c

Maldives Food and Drug Authority

Ministry of Health
Male’, Republic of Maldives

Approved Drug List

Number: MTG/RE-AL/Li 0009/2019-0010

Acronym Expansion Remarks

R Registered product These are pharmaceutical products registered and approved
with full dossier submission. Product safety, quality and
efficacy has been evaluated based on the submitted
documents and certificates of the manufacture and the
product Once registered and approved, it is the
Re Registered product which has
responsibility of the marketing authorization holder to
been given exclusivity under set
provide all necessary information required and if there is any
condition.
change in the product/packaging etc., and to ensure that the
product is available in the market.
EA Exemption Approvals These are special approvals for importing pharmaceutical
products based on minimum evaluation of safety and quality
of the product with information of the imports and
availability in the market of the same. This approval is a
temporary approval granted for a period of 1 year. For
further import after 1 year, it has to be registered by full
dossier submission under the registration criteria. Once
registered by submitting full dossier then it will be added to
the registered product list.
TA Temporary Approvals These are the Products approved based on physicians
requisition forms submitted by clinicians, and these products
are in generic name and Pre Authorization has to be taken
prior to import.These products will be kept as approved
products for a period of 1 year , and as pre authorization
required products. If needed for further import it has to be
registered by full dossier submission under the registeration
criteria.
PP Primordial Products These are the products that has been in Approved Drug List
from the beginning as approved products but not registered
with full dossier submission. This has been kept in the
Approved Drug List due to the unavailability of any
alternative, plus that these products are kept on the fact
that it has been in the market for a long time.
Pre Authorization For all those products highlighted These are in generics and it is mentioned that Pre
required products (PA) in Green Authorization has to be taken prior to import. Pre-
authorization is an approval taken to import these products
and it has to be taken for each product and for every
shipment for import.

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 1 of 2 Authorized by:DG,MFDA
Restricted for Hospital Medicines restricted to special These are the medicines that can only be imported by
and institutional use only expertise and Health facilties and designated parties.These products cannot be kept for sale in
(HI) clinics with registered medical pharmacies.
practitioners

Restricted for Hospital use Medicine restricted to special These are the medicines that can only be imported by
only (HO) expertise for hospitals only designated parties.These products cannot be kept for sale in
pharmacies.
Restricted for the National Restricted to Use for the National These medicines can only be imported to be used by the
programs only (NP) programes only (eg. Filaria, National Programes based on a valid request by the
Leprosy, Malaria, TB,HIV,EPI, concerned agency
Reproductive Health Programs
etc)
CONTROLLED ( C ) Controlled Drugs which include These are medicines which are controlled and can only be
Narcotics and Psychotropics imported by designated parties.From these medicines
(Internationally and Nationally Narcotics cannot be kept in pharmacies for sale
Controlled).
OTC Over the counter medicine (OTC) These are the medicines that can be sold without
prescriptions
POM Prescription only medicine (POM) These are medicines that can be sold to a valid prescription
only.
E Essential medicine These are medicines that are essential and is in the most
recent National Essential medicine list

Updated on: 7th September 2019

Color codes
Category Text/Highlighted Colour Explanation
Prescription Only Black All the "POM" drugs are in black text
Medicine (POM)
Over the Counter (OTC) Blue All the "OTC" drugs are in blue text

CONTROLLED Purple All the "Controlled" medicine are in purple text

Restricted for Hospital Dark Blue All the "Restricted for Hospital use only & Restricted
use only & Restricted for Hospital use/institutional use only" medicines are
for Hospital in dark blue text
use/institutional use
only

Restricted and to be Dark Red All the "Restricted and to be used for the National
used for the National program only" medicines are in dark red text
program only
Pre-Authorization required before import All the "Pre-Authorization required before import"
items are highlighted in light green
Products proposed to be removed after evaluation "Products proposed to be removed after evaluation"
are highlighted in red colour

1. For the Products in this list where the formulation is mentioned, that specific formulation only can be imported
2. For those products in which the fomulation is not mentioned, the product imported should be of export quality and not specified for a
specific market

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 2 of 2 Authorized by:DG,MFDA
 List 1: Registered Product List
These are pharmaceutical products registered and approved with full dossier submission. Product safety, quality and efficacy has been evaluated based on the submitted documents and
certificates of the manufacture and the product Once registered and approved, it is the responsibility of the marketing authorization holder to provide all necessary information required and if
there is any change in the product/packaging etc., and to ensure that the product is available in the market.
Serial No.

Essentiality
Product Generic name Product name Manufacturer / Company Dosage form Strength Catergory Status Registered Remarks
No name Date

1 P2123 ACARBOSE BP Glucar - 50 Glenmark Pharmaceuticals Tablet 50 mg POM R E

Ltd., India

2 P2423 ACECLOFENAC Aceclo Aristo India Tablet 100 mg POM R 25.10.2010 Registered by ADK
Company Pvt Ltd
3 P3678 ACECLOFENAC BP Acelodon 100 Swiss Garnier Life Sciences, Tablet 100 mg POM Re 01.03.2016- Market Exclusivity
No. 21-23, Industrial Area, 28.02.2021 given to AMDC Pvt.
Mehatpur, Dist: UNA, (H.P.)- Ltd.
174 315, India

4 P2716 ACECLOFENAC BP Acedol Torrent Pharmaceuticals, Tablet 100 mg POM R 19.02.2013 Registered by Life
India Support Pvt Ltd
5 P2275 ACECLOFENAC BP Acenac Medley Pharmaceuticals Ltd, Tablet 100 mg POM R Registered by ADK
India. Company Pvt Ltd
6 P3140 ACECLOFENAC BP Aeronac Cassel Research Laboratories, Tablet 100 mg POM R 19.08.2014 Registered by My
India Chemist Wholesale

7 P3508 ACECLOFENAC BP Acenac-SR Medley Pharmaceuticals Ltd, Sustained Release 200 mg POM Re 19.05.2015- Market Exclusivity
India. Tablet 18.05.2020 given to ADK Company
Pvt. Ltd.
8 P3267 ACECLOFENAC BP + LINSEED OIL BP + Stednac Stedman Pharmaceuticals Pvt. Gel 1.5% w/w + 3.0% + 10% + 5% POM R 06.01.2015 Registered by AMDC
METHYL SALICYLATE BP + MENTHOL GEL Ltd., India Pvt Ltd
USP
9 P2427 ACETYL SALICYLIC ACID Delisprin 75 Aristo India Tablet (Delayed 75 mg POM R E 25.10.2010 Registered by ADK
Release) Company Pvt Ltd

10 P3932 ACETYL SALICYLIC ACID (ASPIRIN) Casprin Y.S.P. Industries (M) Sdn. Bhd. Enteric Micro- 100 mg POM Re E 01.11.2016 - Market Exclusivity
Lot 3, 5 & 7, Jalan P/7, Section encaptulated 31.10.2021 given to Treetop
13, Kawasan Perindustrian Capsule Health Pvt. Ltd.
Bandar Baru bangi, 43000
Kajang, Selangor Darul Ehsan,
Malaysia

11 P4329 ACICLOVIR / ACYCLOVIR BP Virox SM Pharmaceuticals Sdn. Bhd. Tablet 200mg POM Re E 02.10.2018 - Market Exclusivity
Lot 88, Sungai Petani 01.10.2023 given to Green
Industrial Estate, 08000 Pharmacy Godown
Sungai Petani, Kedah,
Malaysia

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 1 of 113 Authorized by:DG,MFDA
 12 P4330 ACICLOVIR / ACYCLOVIR BP Virox SM Pharmaceuticals Sdn. Bhd. Tablet 400mg POM Re E 02.10.2018 - Market Exclusivity
Lot 88, Sungai Petani 01.10.2023 given to Green
Industrial Estate, 08000 Pharmacy Godown
Sungai Petani, Kedah,
Malaysia
13 P2611 ACICLOVIR/ ACYCLOVIR Virest Hovid Bhd, Malaysia Cream 5% POM R E 10.07.2012 Registered by GKT
Pharmacy
14 P2185 ACICLOVIR/ ACYCLOVIR Herperax 200 Micro Labs ltd., India Tablet 200 mg POM R E Registered by ADK
Company Pvt Ltd
15 P2607 ACICLOVIR/ ACYCLOVIR Virest Hovid Bhd, Malaysia Tablet 400 mg POM R E 10.07.2012 Registered by GKT
Pharmacy
16 P2608 ACICLOVIR/ ACYCLOVIR Virest Hovid Bhd, Malaysia Tablet 200 mg POM R E 10.07.2012 Registered by GKT
Pharmacy
17 P2804 ACICLOVIR/ ACYCLOVIR Zovirax GlaxoSmithKline , Spain Tablet 200 mg POM R E 26.08.2013 Registered by ADK
Company Pvt Ltd
18 P2805 ACICLOVIR/ ACYCLOVIR Zovirax GlaxoSmithKline , Spain Tablet 800 mg POM R E 26.08.2013 Registered by ADK
Company Pvt Ltd
19 P2203 ACICLOVIR/ ACYCLOVIR Herperax Micro Labs ltd Ointment 5% POM R E Registered by ADK
Company Pvt Ltd
20 P3214 ACICLOVIR/ ACYCLOVIR Zovirax Glaxo Operations, UK Cream 5% w/w POM R E 06.11.2014 Registerd by State
Trading Organization
Plc.
21 P606 ACICLOVIR/ ACYCLOVIR Zovirax GlaxoSmithKline Injection 250mg/vial POM R E 06.11.2014 Registerd by State
Manufacturing S.p.A, Italy Trading Organization
Plc.
22 P1832 ACICLOVIR/ ACYCLOVIR Declovir cream HOE Pharmaceutical Cream 5.00% POM R E
Manufacturing (M) Sdn. Bhd.,
Malaysia
23 P1974 ACICLOVIR/ ACYCLOVIR Virux Square Formulations Tablet 200 mg POM R E
Ltd. Tangail, Bangladesh
24 P3939 ACICLOVIR/ ACYCLOVIR Axcel Acyclovir Kotra Pharma (M) Sdn. Bhd., Cream 5% w/w (5g tube) POM Re E 01.11.2016 - Market Exclusivity
1, 2, & 3 Jalan TTC 12, Cheng 31.10.2021 given to State Trading
Industrial Estate, 75250 Organization Plc.
Melaka, Malaysia

25 P1822 ACICLOVIR/ ACYCLOVIR IP Ocuvir DT 800 FDC Limited, India Dispersible Tablet 800 mg POM R E

26 P2184 ACICLOVIR/ ACYCLOVIR USP Herperax 800 Micro Labs ltd., India Tablet 800 mg POM R E Registered by ADK
Company Pvt Ltd
27 P1336 ACTIVATED DIMETHICONE IP + Colimex Wallace Pharmaceuticals, Oral Drops 10mg + 40mg OTC R 06.01.2015 Registered by AMDC
DICYCLOMINE IP India Pvt Ltd
28 P4070 ACYCLOVIR / ACICLOVIR Lovir Remington Pharmaceutical Ophthalmic 30mg (3.0%) POM Re 03.10.2017 - Market Exclusivity
Industries (Pvt) Ltd, 18km Ointment 02.10.2022 given to ADK
Multan Road, Lahore, Pharmaceutical
Pakistan Company Pvt. Ltd.

29 P4469 ACYCLOVIR / ACICLOVIR Avorax Xepa-Soul Pattinson Tablet 400mg POM Re E 09.04.2019 - Market Exclusivity
(Malaysia) SDN. BHD. 1-5 08.04.2024 given to ADK
Cheng Industrial Estate, 75250 Pharmaceuticals
Melaka, Malaysia Company Pvt. Ltd.

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 2 of 113 Authorized by:DG,MFDA
 30 P2803 ADAPALENE T3 ADA Gel HOE Pharmaceutical Gel 0.1% POM R 26.08.2013 Registered by Dial
Manufacturing (M) Sdn. Bhd., Trade and Travels Pte.
Malaysia Ltd.
31 P795 ADAPALENE Deriva Aqueous Glenmark , India Gel 1% POM R Registered by ADK
Gel Company Pvt Ltd
32 P2340 ADAPALENE + CLINDAMYCIN USP Deriva C Gel Glenmark , India Gel 1 mg + 10 mg POM R 13.05.2010 Registered by ADK
Company Pvt Ltd
33 P2690 ADAPALENE MICROSPHERES Deriva MS GEL Glenmark , India Gel 0.1% w/w POM R 28.01.2013 Registered by ADK
Company Pvt Ltd
34 P2285 ALBENDAZOLE Albex 400 Saga Laboratories, India Tablet 400 mg OTC R E Registered by Dial
Trade and Travels Pte.
Ltd.
35 P1552 ALBENDAZOLE Zentel SKB, Pakistan Tablet 200 mg OTC R E 31.03.2010 Registered by ADK
Company Pvt Ltd
36 P2687 ALBENDAZOLE Albenz Sterling Lab, India. Tablet 400 mg OTC R E 28.01.2013 Registered by AMDC
Pvt Ltd
37 P1970 ALBENDAZOLE Almex Square Pharmaceuticals, Tablet 400 mg OTC R E
Bangladesh
38 P2400 ALBENDAZOLE USP Alworm Medopharm, India Oral Liquid 200mg/ 5 ml OTC R E 30.09.2010 Registered by Green
Suspension Pharmacy
39 P2693 ALBENDAZOLE USP Xenda Micro Labs ltd Tablet 400 mg OTC R E 28.01.2013 Registered by ADK
Company Pvt Ltd
40 P145 ALBENDAZOLE USP Womiban Blue Cross Laboratories India Tablet 400 mg OTC R E Registered by ADK
Company Pvt Ltd
41 P3688 ALENDRONATE SODIUM (ALENDRONIC Osteofos Cipla Ltd, India Tablet 70 mg POM R E 01.03.2016 Registered
ACID) USP
42 P3619 ALENDRONATE SODIUM TRIHYDRATE BonGard PharmEvo (Private) Limited, Tablet 70 mg POM Re E 17.11.2015- Market Exclusivity
(ALENDRONIC ACID) USP Plot # A-29, North Western 16.11.2020 given to Life Support
Industrial Zone, Port Qasim, Pvt. Ltd.
Karachi-75020, Pakistan

43 P1964 ALENDRONIC ACID (ALENDRONATE) Ostel Square Pharmaceuticals, Tablet 10 mg POM R

Bangladesh
44 P2794 ALFACALCIDOL / ALPHACALCIDOL Anibone Pharmix Laboratorie, Pakistan Capsule 0.5 mg POM R E 05.06.2013 Registered by Life
Support Pvt Ltd
45 P3101 ALGINIC ACID BP +MAGNESIUM HYDROXIDE Megacid Sai Mirra Innopharm Pvt Ltd, Oral Liquid 200 mg +250mg + 250 mg + OTC R 20.05.2014 Registered by AMDC
BP +DRIED ALUMINIUM HYDROXIDE BP + India 250 mg + 125 mg in 15ml Pvt Ltd
MAGNESIUM TRISILICATE BP +
DIMETHICONE BP
46 P2819 ALGINIC ACID+DRIED ALMINIUM Emcid Suspension MMC Health Care Ltd,India Oral Liquid 200 mg+ 250 mg+ 250 mg+ 250 OTC R 26.08.2013 Registered by Green
HYDROXIDE+MAGNESIUM HYDROXIDE mg + 125 mg in 15ml Pharmacy
+MAGNESIUM TRISILICATE+DIMETHICONE
BP
47 P2783 ALLOPURINOL Allopurinol Hovid Bhd, Malaysia Tablet 100 mg POM R E 05.06.2013 Registered by GKT
Pharmacy
48 P1045 ALPHA CALCITROL One Alpha Leo pharma, Denmark Capsule 0.25mg POM R
49 P2673 ALPRAZOLAM Zam SR East West Pharma,India Tablet (SR) 1mg INTERNATIONALLY R 22.01.2013 Registerd by State
CONTROLLED Trading Organization
(PSYCHOTROPIC) Plc.

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 3 of 113 Authorized by:DG,MFDA
 50 P2671 ALPRAZOLAM Zam East West Pharma,India Tablet 0.25 mg INTERNATIONALLY R E 22.01.2013 Registerd by State
CONTROLLED Trading Organization
(PSYCHOTROPIC) Plc.
51 P2672 ALPRAZOLAM Zam East West Pharma,India Tablet 0.50 mg INTERNATIONALLY R E 22.01.2013 Registerd by State
CONTROLLED Trading Organization
(PSYCHOTROPIC) Plc.
52 P467 ALUMINIUM HYDROXIDE + MAGNESIUM Trisil plus Efroze Pakistan Oral Liquid ALUMINIUM HYDROXIDE + OTC R E Registered by Green
HYDROXIDE + SIMETHICONE MAGNESIUM HYDROXIDE + Pharmacy
SIMETHICONE
53 P843 ALUMINIUM HYDROXIDE + MAGNESIUM Zellox – II Double HOE Pharmaceutical Oral Liquid 800 mg+800 mg+ 60 mg in 10 OTC R E Registered by Dial
HYDROXIDE + SIMETHICONE Manufacturing (M) Sdn. Bhd., ml Trade and Travels Pte.
Malaysia Ltd.
54 P2874 ALUMINIUM HYDROXIDE BP + MAGNESIUM Relcer Glenmark , India Tablet 250mg +250mg + 4mg+40mg OTC R E 07.01.2014 Registered by ADK
HYDROXIDE USP + LIQUORICE + Company Pvt Ltd
SIMETHICONE USP
55 P2526 ALUMINIUM HYDROXIDE BP + MAGNESIUM Filmacid M Searle, Pakistan Oral Liquid 300 mg + 150 mg + 125 mg in OTC R E 23.06.2011 Registered by ADK
HYDROXIDE+ SIMETHICONE USP 5ml Company Pvt Ltd

56 P2870 ALUMINIUM HYDROXIDE IP + MAGNESIUM Diovol Forte Wallace Pharmaceuticals, Oral Liquid 300 mg + 250 mg + 40 mg in OTC R E 07.01.2014 Registered by AMDC
HYDROXIDE IP + ACTIVATED DIMETHICONE Suspension India 5ml Pvt Ltd
IP
57 P802 ALUMINIUM HYDROXIDE USP + Relcer Glenmark , India Oral Liquid 365 mg + 80 mg + 100 mg + OTC R E Registered by ADK
MAGNESIUM HYDROXIDE USP + 400 mg in 5 ml Company Pvt Ltd
SIMETHICONE USP + LIQUORICE
58 P969 ALUMINIUM HYDROXIDE+ MAGNESIUM Digene gel Abbott India Oral Liquid 830 mg (IP) + 185 mg (IP)+ OTC R E 20.05.2014 Registered by Life
HYDROXIDE+ SIMETHICONE+SODIUM 50mg(IP)+100 Support Pvt Ltd
CARBOXYMETHYLCELLULOSE mg(IP) in 10ml

59 P2298 AMBROXODIL HCL Ambrodil Aristo India Oral Liquid 30mg/5 ml POM R Registered by ADK
Company Pvt Ltd
60 P2299 AMBROXODIL HCL IP Ambrodil Aristo India Tablet 30 mg POM R Registered by ADK
Company Pvt Ltd
61 P2492 AMBROXOL HCL BP + GUAIPHENESIN BP + Cofsy Oral liquid MMC Health Care Ltd,India Oral Liquid 15 mg + 50 mg + 1 mg + 1 mg POM R 23.02.2011 Registered by Green
SALBUTAMOL SULPHATE + MENTHOL BP in 5ml Pharmacy

62 P2401 AMBROXOL HCL BP + GUAIPHENESIN BP + Exolit Oral liquid Medopharm, India Oral Liquid 15mg + 50 mg + 1.25 mg in POM R 30.09.2010 Registered by Green
TERBUTALINE SULPHATE BP 5ml Pharmacy
63 P2415 AMBROXOL HDL + SALBUTAMOL SULPHATE Ambrodil S Aristo India Oral Liquid 15 mg + 1 mg POM R 07.10.2010 Registered by ADK
Company Pvt Ltd
64 P1802 AMIKACIN Amikin Injection Bristol Myers Squibb Pakistan Injection 500mg in 2ml POM R E
500mg
65 P1804 AMIKACIN Amikin Bristol Myers Squibb Pakistan Injection 100 mg/2ml POM R E

66 P1803 AMIKACIN Amikin Bristol Myers Squibb Pakistan Injection 250mg/2ml POM R E

67 P2523 AMINOPHYLLINE + AMMONIUM CHLORIDE Hydrllin Searle, Pakistan Oral Liquid 32 mg + 30 mg + 8 mg in 5ml POM R 23.06.2011 Registered by ADK
+ DIPHENHYDRAMINE HCL Company Pvt Ltd
68 P2335 AMITRIPTYLINE BP Amitriptyline Ambalal Sarabhai Tablet 10 mg POM R E 09.05.2010 Registered by ADK
India/Assence Pharma Pvt Ltd Company Pvt Ltd

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 4 of 113 Authorized by:DG,MFDA
 69 P2336 AMITRIPTYLINE BP Amitriptyline Ambalal Sarabhai Tablet 25 mg POM R E 09.05.2010 Registered by ADK
India/Assence Pharma Pvt Ltd Company Pvt Ltd

70 P2854 AMLODIPINE Hovasc 5 Hovid Bhd, Malaysia Tablet 5 mg POM R E 07.11.2013 Registered by GKT
Pharmacy
71 P2855 AMLODIPINE Hovasc 10 Hovid Bhd, Malaysia Tablet 10 mg POM R E 07.11.2013 Registered by GKT
Pharmacy
72 P2240 AMLODIPINE Amlosafe 5 Aristo India Tablet 5 mg POM R E Registered by ADK
Company Pvt Ltd
73 P2504 AMLODIPINE Amlopress Cipla India Tablet 5 mg POM R E Registered by ADK
Company Pvt Ltd
74 P510 AMLODIPINE Amodep FDC India Tablet 5mg POM R E

75 P1127 AMLODIPINE BESYLATE Primodil 5 Medley Pharmaceuticals Ltd. Uncoated Tablet 5mg POM Re E 02.10.2018 - Market Exclusivity
Plot No. 18 & 19, Survey No. 01.10.2023 given to ADK
378/7 & 8, 379/2&3, Zari Pharmaceutical
Causeway Road, Kachigam, Company Pvt. Ltd.
Daman - 396210, India

76 P3180 AMLODIPINE BESYLATE + VALSARTAN Exforge Novartis Farmaceutica S.A., Tablet 5 mg + 80 mg POM R 16.09.2014 Registered by
Spain Mediquip Maldives
Pvt. Ltd.
77 P3716 AMLODIPINE BESYLATE + VALSARTAN Exforge Novartis Farmaceutica S.A., Film coated Tablet 5mg+160mg POM Re 17.05.2016 - Market Exclusivity
Spain 16.05.2021 given to Mediquip
Maldives Pvt. Ltd.
78 P3717 AMLODIPINE BESYLATE + VALSARTAN Exforge Novartis Farmaceutica S.A., Film coated Tablet 10mg+160mg POM Re 17.05.2016 - Market Exclusivity
Spain 16.05.2021 given to Mediquip
Maldives Pvt. Ltd.
79 P3986 AMLODIPINE BESYLATE USP Amloswiz-5 Swiss Garnier Life Sciences, Uncoated Tablet 5mg POM Re 20.06.2017 - Market Exclusivity
No:21-23 Industrial Area, 20.06.2022 given to AMDC Pvt.
Mehatpur, Dist UNA, Ltd.
Himachel Pradesh, 174315,
INDIA

80 P2337 AMLODIPINE BP Amsach Ambalal Sarabhai Tablet 2.5 mg POM R E 09.05.2010 Registered by ADK
India/Assence Pharma Pvt Ltd Company Pvt Ltd

81 P2338 AMLODIPINE BP Amsach Ambalal Sarabhai Tablet 5 mg POM R E 09.05.2010 Registered by ADK
India/Assence Pharma Pvt Ltd Company Pvt Ltd

82 P2339 AMLODIPINE BP Amsach Ambalal Sarabhai Tablet 10 mg POM R E 09.05.2010 Registered by ADK
India/Assence Pharma Pvt Ltd Company Pvt Ltd

83 P2717 AMLODIPINE BP Amlocor 5 Torrent Pharmaceuticals, Tablet 5 mg POM R E 19.02.2013 Registered by Life
India Support Pvt Ltd
84 P2197 AMLODIPINE BP Amlong 10 Micro Labs Limited, 92, Tablet 10 mg POM R E Registered by ADK
SIPCOT, HOSUR-635 126 INDIA Company Pvt Ltd

85 P1894 AMLODIPINE BP Camlodin Square Pharmaceuticals, Tablet 5 mg POM R E

Bangladesh

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 5 of 113 Authorized by:DG,MFDA
 86 P2198 AMLODIPINE BP Amlong 5 Micro Labs ltd Tablet 5 mg POM R E Registered by ADK
Company Pvt Ltd
87 P3531 AMLODIPINE BP D-Lip 5 Atoz Pharmaceuticals, India Tablet 5 mg POM Re E 19.05.2015- Market Exclusivity
18.05.2020 given to My Chemist
Wholesale
88 P3532 AMLODIPINE BP D-Lip 10 Atoz Pharmaceuticals, India Tablet 10 mg POM Re E 19.05.2015- Market Exclusivity
18.05.2020 given to My Chemist
Wholesale
89 P3726 AMLODIPINE BP Stamlo 5 Dr.Reddy's Laboratories Tablet 5mg POM Re E 17.05.2016 - Market Exclusivity
Ltd.,India 16.05.2021 given to State Trading
Organization Plc.

90 P3727 AMLODIPINE BP Stamlo 10 Dr.Reddy's Laboratories Tablet 10mg POM Re E 17.05.2016 - Market Exclusivity
Ltd.,India 16.05.2021 given to State Trading
Organization Plc.

91 P3512 AMLODIPINE IP Primodil Medley Ltd, India. Tablet 10 mg POM Re E 19.05.2015- Market Exclusivity
18.05.2020 given to ADK Company
Pvt. Ltd.
92 P2490 AMLODIPINE USP Amlowin MMC Health Care Ltd,India Tablet 10 mg POM R E 23.02.2011 Registered by Green
Pharmacy
93 P2315 AMOXICILLIN Amoxil Glaxo Wellcome, France Capsule 500 mg POM R E 28.02.2010 Registered by ADK
Company Pvt Ltd
94 P2316 AMOXICILLIN Amoxil Glaxo Wellcome, France Capsule 250 mg POM R E 28.02.2010 Registered by ADK
Company Pvt Ltd
95 P2663 AMOXICILLIN Amoxicap Hovid Bhd, Malaysia Capsule 250 mg POM R E 27.11.2012 Registered by GKT
Pharmacy
96 P2664 AMOXICILLIN Amoxicap Hovid Bhd, Malaysia Capsule 500mg POM R E 27.11.2012 Registered by GKT
Pharmacy
97 P2650 AMOXICILLIN Moxol Sterling Lab, India. Capsule 500 mg POM R E 02.10.2012 Registered by AMDC
Pvt Ltd
98 P146 AMOXICILLIN Blumox Blue Cross Laboratories India Tablet 125 mg POM R E Registered by ADK
Company Pvt Ltd
99 P2324 AMOXICILLIN Amoxil Glaxo Wellcome, France Oral Liquid 125mg / 5 ml POM R E 31.03.2010 Registered by ADK
Company Pvt Ltd
100 P26 AMOXICILLIN Amoxycillin Alembic Pharmaceuticals Capsule 250 mg POM R E Registered by Dial
Limited India Trade and Travels Pte.
Ltd.
101 P27 AMOXICILLIN Amoxycillin Alembic Pharmaceuticals Capsule 500 mg POM R E Registered by Dial
Limited India Trade and Travels Pte.
Ltd.
102 P1988 AMOXICILLIN Medomox 250 Medopharm, India Capsule 250 mg POM R E Registered by Green
Pharmacy
103 P1989 AMOXICILLIN Medomox 500 Medopharm, India Capsule 500 mg POM R E Registered by Green
Pharmacy
104 P2447 AMOXICILLIN Medomox Medopharm, India Oral Liquid 125 mg / 5 ml POM R E 22.10.2010 Registered by Green
Pharmacy
105 P2448 AMOXICILLIN Medomox Medopharm, India Oral Liquid 250 mg / 5 ml POM R E 22.10.2010 Registered by Green
Pharmacy

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 6 of 113 Authorized by:DG,MFDA
 106 P2787 AMOXICILLIN Amoxigran Hovid Bhd, Malaysia Oral Liquid 250 mg/5 ml POM R E 05.06.2013 Registered by GKT
Pharmacy
107 P2018 AMOXICILLIN Genamox General Pharmacueticals Capsule 250 mg POM R E
Ltd,Bangladesh
108 P1923 AMOXICILLIN Beamoxy granules Upha Pharmaceutical Oral Liquid 125mg/5ml POM R E
125 Manufacturing (M) Sdn. Bhd.,
Malaysia
109 P2014 AMOXICILLIN Genamox General Pharmacueticals Ltd, Oral Drops 125 mg /1.25ml POM R E
Paediatric drops Bangladesh

110 P2022 AMOXICILLIN Genamox General Pharmacueticals Ltd, Oral Liquid 125 mg /5 mg POM R E
Bangladesh
111 P2902 AMOXICILLIN Amoxicillin Cresent Pharma, London Oral Liquid 125mg/5ml POM R E 18.02.2014 Registered by Life
Support Pvt Ltd
112 P4279 AMOXICILLIN + CLAVULANATE POTASSIUM Clavamox PT. Dankos Farma JI. Rawa Oral Suspension 125mg/5ml (125mg + POM Re E 17.04.2018 - Market Exclusivity
Gatel Block III S, Kav. 37-38, (Dry syrup) 31.25mg) 16.04.2023 given to State Trading
Kawasan Industri Pulo Gadung Organization Plc.
Jakata 13930, Indonesia. (For
PT. Kalbe Farma TBK Kawasan
Industri Delta Silicon JI. M.H.
Thamrin Blok A3-1, Lippo
Cikarang Bekasi, Indonesia)

113 P2313 AMOXICILLIN + CLAVULANIC ACID Augmentin GlaxoSmithKline , UK Oral Drops 50mg + 12.5 mg POM R E 28.02.2010 Registered by ADK
Company Pvt Ltd
114 P3161 AMOXICILLIN + CLAVULANIC ACID Clamovid BID Bilim Pharmaceuticals, Turkey Granules (Dry 228 mg/5 ml ( 200mg+ 28 mg) POM R E 19.08.2014 Registered by GKT
Oral liquid) Pharmacy

115 P3251 AMOXICILLIN + CLAVULANIC ACID Hovid Clamovid Hovid Bhd, Malaysia Injection 1000 mg + 200 mg POM R E 06.01.2015 Registered by GKT
Pharmacy
116 P2724 AMOXICILLIN + CLAVULANIC ACID Clamovid Bilim Pharmaceuticals, Turkey Oral Suspension 156.25mg/5 ml (125mg + POM R E 05.03.2013 Registered by GKT
31.25) Pharmacy
117 P1554 AMOXICILLIN + CLAVULANIC ACID Augmentin GlaxoSmithKline , UK Injection 1g+200 mg POM R E Registered by ADK
Company Pvt Ltd
118 P1573 AMOXICILLIN + CLAVULANIC ACID Augmentin SKB, UK Injection 500 mg + 100 mg POM R E Registered by ADK
Company Pvt Ltd
119 P1557 AMOXICILLIN + CLAVULANIC ACID Augmentin GlaxoSmithKline , UK Tablet 250 mg + 125 mg POM R E Registered by ADK
Company Pvt Ltd
120 P1574 AMOXICILLIN + CLAVULANIC ACID Augmentin SKB, UK Tablet 500 mg+125mg POM R E Registered by ADK
Company Pvt Ltd
121 P1555 AMOXICILLIN + CLAVULANIC ACID Augmentin GlaxoSmithKline , UK Oral Liquid 156 mg/ 5 ml POM R E Registered by ADK
Company Pvt Ltd
122 P1556 AMOXICILLIN + CLAVULANIC ACID Augmentin GlaxoSmithKline , UK Oral Liquid 228 mg/5 ml POM R E Registered by ADK
Company Pvt Ltd
123 P2723 AMOXICILLIN + CLAVULANIC ACID Clamovid Bilim Pharmaceuticals, Turkey Tablet 625 mg ( 500 mg + 125mg) POM R E 05.03.2013 Registered by GKT
Pharmacy
124 P2173 AMOXICILLIN + CLAVULANIC ACID Cledomox Medopharm, India Oral Liquid 228.5mg/5ml POM R E
125 P2130 AMOXICILLIN + CLAVULANIC ACID Avacan 375 Khandelwal Laboratories Pvt Tablet 375 mg POM R E
Ltd

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Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 7 of 113 Authorized by:DG,MFDA
 126 P2131 AMOXICILLIN + CLAVULANIC ACID Avacan 625 Khandelwal Laboratories Pvt Tablet 625 mg POM R E
Ltd
127 P3561 AMOXICILLIN + CLAVULANIC ACID Clamovid Hovid Bhd. 121, Jalan Tunku Injection 500 mg + 100 mg POM Re E 08.09.2015 - Market Exclusivity
Abdul Rahman, 30010 Ipoh, 07.09.2020 given to My Chemist
Malaysia Wholesale
128 P2623 AMOXICILLIN + CLAVULANIC ACID BP Bactoclav Dry Oral Micro Labs ltd Oral Liquid 250 mg + 62.5 mg POM R E 18.09.2012 Registered by ADK
liquid Company Pvt Ltd
129 P2624 AMOXICILLIN + CLAVULANIC ACID BP Bactoclav Dry Oral Micro Labs ltd Oral Liquid 125 mg + 31.25 mg POM R E 18.09.2012 Registered by ADK
liquid Company Pvt Ltd
130 P2245 AMOXICILLIN + CLAVULANIC ACID BP Bactoclav 375 Micro Labs ltd Tablet 375 mg POM R E Registered by ADK
Company Pvt Ltd
131 P2246 AMOXICILLIN + CLAVULANIC ACID BP Bactoclav 625 Micro Labs ltd Tablet 625 mg POM R E Registered by ADK
Company Pvt Ltd
132 P2171 AMOXICILLIN + CLAVULANIC ACID BP Cledomox 375 Medopharm, India Tablet 375 mg POM R E
133 P2172 AMOXICILLIN + CLAVULANIC ACID BP Cledomox 625 Medopharm, India Tablet 625 mg POM R E
134 P3655 AMOXICILLIN TRIHYDRATE + CLAVULANIC Novaclav 625 Cipla India Tablet 500 mg + 125 mg POM R E 21.01.2016 Registered
ACID
135 P3992 AMOXICILLIN TRIHYDRATE USP + Clavamox PT Dankos Farma, JI. Rawa Film Coated tablet 500mg + 125mg POM Re E 01.08.2017 - Market Exclusivity
POTASSIUM CLAVULANATE USP Gatel Blok III S, Kav. 37-38, 01.08.2022 given to State Trading
Kawasan Industri Pulo Gadung Organization Plc.
Jakarta 13930-Indonesia

136 P1925 AMPICILLIN Ampicillin granules Upha Pharmaceutical Oral Liquid 125mg/5ml POM R E
125 Manufacturing (M) Sdn. Bhd.,
Malaysia
137 P3252 AMPICILLIN + SULBACTAM USP Hovid Sulbacyn Hovid Bhd, Malaysia Injection 500 mg + 250 mg POM R 06.01.2015 Registered by GKT
Pharmacy
138 P3254 AMPICILLIN + SULBACTAM USP Hovid Sulbacyn Hovid Bhd, Malaysia Injection 1000 mg +500 mg POM R 06.01.2015 Registered by GKT
Pharmacy
139 P2657 AMPICILLIN USP Ampicillin Swiss Parentrals,India Injection 500 mg POM R E 27.11.2012 Registered by Life
Support Pvt Ltd
140 P2871 AMUMINIUM HYDROXIDE IP + MAGNESIUM Diovol Tablet Wallace Pharmaceuticals, Tablet (Chewable) 240 mg + 100 mg + 60 mg + 25 POM R 07.01.2014 Registered by AMDC
HYDROXIDE IP + LIGHT MAGNESIUM India mg Pvt Ltd
CARBONATE IP + ACTIVATED DIMETHICONE
IP
141 P4467 ANASTROZOLE USP Anzonat Natco Pharma Limited Kothur- Tablet 1mg POM Re 09.04.2019 - Market Exclusivity
509 228, Rangareddy District 08.04.2024 given to ADK
Telangana, India Pharmaceuticals
Company Pvt. Ltd.
142 P2113 ANTAZOLINE + TETRAZOLIN Allerex Eye Drops Ashford Laboratories Ltd Eye Drops 0.05% + l 0.4% POM R

143 P2242 ASCORBIC ACID C-VIT Cipla India Tablet 500 mg OTC R E 30.07.2009 Registered by ADK
Company Pvt Ltd
144 P965 ASCORBIC ACID Xon-ce PT Kalbe Farma, JI.M.H. Chewable Tablet 500 mg OTC Re E 06.12.2016 - Market Exclusivity
Thamrin Blok A3-1, Kawasan 05.12.2021 given to State Trading
Industri Delta Silicon, Lippo Organization Plc.
Cikarang, Bekasi, INDONESIA

MTG Division, MFDA Rec. Name: Approved Drug List

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Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 8 of 113 Authorized by:DG,MFDA
 145 P3596 ASCORBIC ACID Limcee Ambalal Sarabhai Chewable Tablet 500 mg OTC R E 24.06.2014 Registered by ADK
India/Assence Pharma Pvt Ltd Company Pvt Ltd

146 P3598 ASCORBIC ACID Vitcee 500 Medopharm, India Chewable Tablet 500 mg OTC R E Registered by Green
Pharmacy
147 P1922 ASCORBIC ACID (VITAMIN C) Champs C with Upha Pharmaceutical Tablet 100mg OTC R E
Lysine Manufacturing (M) Sdn. Bhd.,
Malaysia
148 P1914 ASCORBIC ACID (VITAMIN C) Flavettes Vitamin C Upha Pharmaceutical Tablet 250mg OTC R E
Blackcurrant Manufacturing (M) Sdn Bhd
250mg

149 P1915 ASCORBIC ACID (VITAMIN C) Flavettes Tablet Upha Pharmaceutical Tablet 500mg OTC R E
500mg (Orange) Manufacturing (M) Sdn. Bhd.,
Malaysia
150 P3599 ASCORBIC ACID (VITAMIN C) BP Well-C Aeon Formulations Pvt. Ltd., Chewable Tablet 500 mg OTC Re E 20.10.2015 - Market Exclusivity
India 19.10.2020 given to Moonima
Medicals
151 P4122 ASCORBIC ACID USP + SODIUM ASCORBATE Flavettes Tablet Upha Pharmaceutical Tablet 96.08mg + 328mg OTC R
500mg (Orange) Manufacturing (M) Sdn. Bhd.

152 P4123 ASCORBIC ACID USP + SODIUM ASCORBATE Flavettes Tablet Upha Pharmaceutical Tablet 96.08mg+ 173.23mg OTC R
250mg (Orange) Manufacturing (M) Sdn. Bhd.

153 P4124 ASCORBIC ACID USP + SODIUM ASCORBATE Flavettes Sugar Upha Pharmaceutical Tablet 96.08mg+ 173.23mg OTC R
Free C Tablet Manufacturing (M) Sdn. Bhd.
250mg (Orange)
154 P4121 ASCORBIC ACID, SODIUM ASCORBATE Flavettes Vitamin C Upha Pharmaceutical Tablet 96.08mg+ 173.23mg OTC R
Blackcurrant Manufacturing (M) Sdn. Bhd.
250mg

155 P4165 ASORBIC ACID + SODIUM ASCORBIC Chewette Hovid Bhd, Malaysia Tablet 56.70mg + 51.20mg OTC R Registered by GKT
Pharmacy
156 P320 ASPARTAME Lo cal Cipla India Tablet 20 x 1g OTC R Registered by ADK
Company Pvt Ltd
157 P2517 ATENOLOL B.P Norm 50 Medley Ltd, India. Tablet 50 mg POM R 23.06.2011 Registered by ADK
Company Pvt Ltd
158 P2862 ATENOLOL Ternolol Hovid Bhd, Malaysia Tablet 50 mg POM R 07.11.2013 Registered by GKT
Pharmacy
159 P1650 ATENOLOL Tensimin Unique, India Tablet 100mg POM R Registered by ADK
Company Pvt Ltd
160 P1651 ATENOLOL Tensimin Unique, India Tablet 50mg POM R Registered by ADK
Company Pvt Ltd
161 P2743 ATENOLOL Atenolol Cresent Pharma,London Tablet 25 mg POM R 08.05.2013 Registered by Life
Support Pvt Ltd
162 P2744 ATENOLOL Atenolol Cresent Pharma,London Tablet 50 mg POM R 08.05.2013 Registered by Life
Support Pvt Ltd
163 P2287 ATORVASTATIN Carato Saga Laboratories, India Tablet 10mg POM R E Registered by Dial
Trade and Travels Pte.
Ltd.

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 9 of 113 Authorized by:DG,MFDA
 164 P3108 ATORVASTATIN Hovid Lipiduce 10 Hovid Bhd, Malaysia Tablet 10 mg POM R E 20.05.2014 Registered by GKT
Pharmacy
165 P3109 ATORVASTATIN Hovid Lipiduce 20 Hovid Bhd, Malaysia Tablet 20mg POM R E 20.05.2014 Registered by GKT
Pharmacy
166 P1128 ATORVASTATIN Atorin - 10 Medley Ltd, India. Tablet 10mg POM R E Registered by ADK
Company Pvt Ltd
167 P1129 ATORVASTATIN Atorin - 20 Medley Ltd, India. Tablet 20mg POM R E Registered by ADK
Company Pvt Ltd
168 P2188 ATORVASTATIN Astat 20 Micro Labs ltd Tablet 20 mg POM R E Registered by ADK
Company Pvt Ltd
169 P2189 ATORVASTATIN Astat 10 Micro Labs ltd Tablet 10 mg POM R E Registered by ADK
Company Pvt Ltd
170 P2648 ATORVASTATIN Litor Sterling Lab, India. Tablet 20 mg POM R E 02.10.2012 Registered by AMDC
Pvt Ltd
171 P2649 ATORVASTATIN Litor Sterling Lab, India. Tablet 10mg POM R E 02.10.2012 Registered by AMDC
Pvt Ltd
172 P3259 ATORVASTATIN Lilo Hetro Labs Limited, India Tablet 10 mg POM R E 06.01.2015 Registerd by State
Trading Organization
Plc.
173 P2117 ATORVASTATIN Emstat 10 Medopharm, India Tablet 10 mg POM R E
174 P2118 ATORVASTATIN Emstat 20 Medopharm, India Tablet 20 mg POM R E
175 P3690 ATORVASTATIN Atocor 10 Dr Reddy`s Laboratories,India Tablet 10 mg POM Re E 01.03.2016- Market Exclusivity
28.02.2021 given to State Trading
Organization Plc.

176 P3691 ATORVASTATIN Atocor 20 Dr Reddy`s Laboratories,India Tablet 20mg POM Re E 01.03.2016- Market Exclusivity
28.02.2021 given to State Trading
Organization Plc.

177 P3692 ATORVASTATIN Atocor 40 Dr Reddy`s Laboratories,India Tablet 40 mg POM Re E 01.03.2016- Market Exclusivity
28.02.2021 given to State Trading
Organization Plc.

178 P2739 ATORVASTATIN BP Modlip 10 Torrent Pharmaceuticals, Tablet 10 mg POM R E 08.05.2013 Registered by Life
India Support Pvt Ltd
179 P2740 ATORVASTATIN BP Modlip 20 Torrent Pharmaceuticals, Tablet 20 mg POM R E 08.05.2013 Registered by Life
India Support Pvt Ltd
180 P3653 ATORVASTATIN CALCIUM Atorlip 20 Cipla Ltd. Mumbai Central, Tablet 20 mg POM R E 21.01.2016 Registered
Mumbai-400 008, India

181 P3654 ATORVASTATIN CALCIUM Atorlip 10 Cipla Ltd. Mumbai Central, Tablet 10 mg POM R E 21.01.2016 Registered
Mumbai-400 008, India

182 P2129 ATORVASTATIN IP Atorin 5 Medley Ltd, India. Tablet 5 mg POM R E

183 P3458 ATORVASTATIN USP Tiginor Incepta pharmaceuticals Tablet 10 mg POM Re E 24.03.2015 - Market Exclusivity
Limited, Bangladesh 23.03.2020 given to Dial Trade
and Travels Pte. Ltd.
184 P2817 ATORVASTATIN USP Trova 10 MMC Health Care Ltd,India Tablet 10 mg POM R E 26.08.2013 Registered by Green
Pharmacy

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 10 of 113 Authorized by:DG,MFDA
 185 P2818 ATORVASTATIN USP Trova 20 MMC Health Care Ltd,India Tablet 20 mg POM R E 26.08.2013 Registered by Green
Pharmacy
186 P3213 ATRACURIUM Tracrium GlaxoSmithKline Injection 50mg/ 5ml Restricted for R E 06.11.2014 Registerd by State
Manufacturing S.p.A, Italy Hospital use only Trading Organization
Plc.
187 P12 ATROPINE SULPHATE Isopto atropine 1% Alcon,Belgium Eye Drops 1% POM R E 02.01.2000 Registered by ADK
Company Pvt Ltd
188 P2334 AZITHROMYCIN Azisara Ambalal Sarabhai Capsule 250 mg POM R E 09.05.2010 Registered by ADK
India/Assence Pharma Pvt Ltd Company Pvt Ltd

189 P28 AZITHROMYCIN Azithral Alembic Pharmaceuticals Tablet 500mg POM R E Registered by Dial
Limited India Trade and Travels Pte.
Ltd.
190 P29 AZITHROMYCIN Azithral Alembic Pharmaceuticals Oral Liquid 200mg/5ml POM R E Registered by Dial
Limited India Trade and Travels Pte.
Ltd.
191 P2444 AZITHROMYCIN Ortiza Medopharm, India Tablet 250 mg POM R E 22.10.2010 Registered by Green
Pharmacy
192 P3454 AZITHROMYCIN Tridosil 500 Incepta pharmaceuticals Tablet 500 mg POM Re E 24.03.2015 - Market Exclusivity
Limited, Bangladesh 23.03.2020 given to Dial Trade
and Travels Pte. Ltd.
193 P3480 AZITHROMYCIN Alide Pharmix Laboratories Pakistan Suspension 200 mg/ 5 ml POM Re E 21.04.2015 - Market Exclusivity
20.04.2020 given to Life Support
Pvt. Ltd.
194 P3757 AZITHROMYCIN DIHYDRATE USP Zimax 500 Square Pharmaceuticals, Film coated tablet 500 mg POM Re E 06.09.2016 - Market Exclusivity
Bangladesh 05.09.2021 given to Dial Trade
and Travels Pte. Ltd.
195 P3758 AZITHROMYCIN DIHYDRATE USP Zimax 250 Square Pharmaceuticals, Capsule 250 mg POM Re E 06.09.2016 - Market Exclusivity
Bangladesh 05.09.2021 given to Dial Trade
and Travels Pte. Ltd.
196 P1729 AZITHROMYCIN IP Aziwok Wockhardt, India Capsule 250 mg POM R E
197 P2311 AZITHROMYCIN USP Aziwok Suspension Wockhardt, India Oral Liquid 200 mg /5 ml POM R E Registered by Life
Support Pvt Ltd
198 P2443 AZITHROMYCIN USP Ortiza Medopharm, India Tablet 500 mg POM R E 22.10.2010 Registered by Green
Pharmacy
199 P2282 AZITHROMYCIN USP Zithrocin Astron Limited, Sri Capsule 250 mg POM R E Registered by ADK
Lanka Company Pvt Ltd
200 P2186 AZITHROMYCIN USP Azilide 500 Micro Labs ltd Tablet 500 mg POM R E Registered by ADK
Company Pvt Ltd
201 P2187 AZITHROMYCIN USP Azilide 250 Micro Labs ltd Tablet 250 mg POM R E Registered by ADK
Company Pvt Ltd
202 P2484 AZITHROMYCIN USP Azithrotab MMC Health Care Ltd,India Tablet 250 mg POM R E 23.02.2011 Registered by Green
Pharmacy
203 P2485 AZITHROMYCIN USP Azithrotab MMC Health Care Ltd,India Tablet 500 mg POM R E 23.02.2011 Registered by Green
Pharmacy
204 P3479 AZITHROMYCIN USP Alide Pharmix Laboratories Pakistan Capsule 500 mg POM Re E 21.04.2015 - Market Exclusivity
20.04.2020 given to Life Support
Pvt. Ltd.

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 11 of 113 Authorized by:DG,MFDA
 205 P3524 AZITHROMYCIN USP Inozith-500 Atoz Pharmaceuticals, India Tablet 500 mg POM Re E 19.05.2015- Market Exclusivity
18.05.2020 given to My Chemist
Wholesale
206 P160 AZTREONAM Azactam 0.5g Bristol Myers Squibb Pakistan Injection 500 mg POM R Registered by ADK
Company Pvt Ltd
207 P161 AZTREONAM Azactam 1 g Bristol Myers Squibb Pakistan Injection 1 gm POM R Registered by ADK
Company Pvt Ltd
208 P2168 AZTREONAM Azenam 1 g Aristo India Injection 1g POM R
209 P1246 BACLOFEN Lioresal Novartis Farma Italy, / Tablet 25 mg POM R E 02.02.2010 Registerd by State
Norvartis Pharma Trading Organization
AG/Switzerland Plc.
210 P1247 BACLOFEN Lioresal Novartis Farma, Italy / Tablet 10mg POM R E 02.02.2010 Registerd by State
Norvartis Pharma Trading Organization
AG/Switzerland Plc.
211 P807 BECLOMETASONE + CLOTRIMAZOLE Candid B Glenmark , India Cream 0.025% +1% POM R 16.08.2010 Registered by ADK
Company Pvt Ltd
212 P808 BECLOMETASONE + CLOTRIMAZOLE Candid B Glenmark , India Lotion 0.025% +1% POM R Registered by ADK
Company Pvt Ltd
213 P2120 BECLOMETASONE BP + SALICYLIC ACID BP Ecziderm S Glenmark , India Topical Ointment 0.025% w/w + 3% w/w POM R

214 P2907 BECLOMETHASONE Ibicar 250 Glenmark , India Oral Inhaler 250 mcg/md POM R E 18.02.2014 Registered by ADK
Company Pvt Ltd
215 P3215 BECLOMETHASONE Ibicar 100 Glenmark , India Oral Inhaler 100 mcg/md POM R E 06.11.2014 Registered by ADK
Company Pvt Ltd
216 P3216 BECLOMETHASONE Ibicar 200 Glenmark , India Oral Inhaler 200 mcg/md POM R E 06.11.2014 Registered by ADK
Company Pvt Ltd
217 P2509 BECLOMETHASONE Cycloson 400 Pharmachemie BV, The Inhalation Capsule 400µg POM R E 25.05.2011 Registered by ADK
Netherland Company Pvt Ltd
218 P2510 BECLOMETHASONE Cycloson 200 Pharmachemie BV, The Inhalation Capsule 200µg POM R E 25.05.2011 Registered by ADK
Netherland Company Pvt Ltd
219 P237 BECLOMETHASONE Beclate Cipla India Aerosol 100 mcg/md POM R E Registered by ADK
Company Pvt Ltd
220 P239 BECLOMETHASONE Beclate Cipla India Aerosol 200 mcg/md POM R E 17.12.2009 Registered by ADK
Company Pvt Ltd
221 P2797 BECLOMETHASONE Beclate Cipla India Aerosol 250 mcg/md POM R E 26.08.2013 Registered by ADK
Company Pvt Ltd
222 P686 BECLOMETHASONE Becodisk Glaxo Wellcome , UK Inhaler 100mcg POM R E Registered by ADK
Company Pvt Ltd
223 P687 BECLOMETHASONE Becodisk Glaxo Wellcome , UK Inhaler 200mcg POM R E Registered by ADK
Company Pvt Ltd
224 P688 BECLOMETHASONE Becodisk Glaxo Wellcome , UK Inhaler 400mcg POM R E Registered by ADK
Company Pvt Ltd
225 P241 BECLOMETHASONE Beclate aquanase Cipla India Nasal Spray 50 mcg/md POM R E 17.12.2009 Registered by ADK
Company Pvt Ltd
226 P221 BECLOMETHASONE Clenil Forte Spray Chiesi Farmaceutici SPA Italy Inhaler 250mcg/metered dose POM R E

227 P222 BECLOMETHASONE Clenil Spray Chiesi Farmaceutici SPA Italy Inhaler 50mcg/metered dose POM R E

228 P223 BECLOMETHASONE Rino Clenil spray Chiesi Farmaceutici SPA Italy Inhaler 100 mcg/ml POM R E

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 12 of 113 Authorized by:DG,MFDA
 229 P2000 BECLOMETHASONE DIPROPIONATE IP + Beclosal Cream 15 Liva Health Ltd ,India Cream 0.025% + 3.000 W/W POM R Registered by Green
SALICYLIC ACID IP G Pharmacy
230 P2005 BECLOMETHASONE DIPROPIONATE IP + Beclosal Ointment Liva Health Ltd ,India Ointment 0.025% + 3.000% W/W POM R Registered by Green
SALICYLIC ACID IP 10G Pharmacy
231 P3687 BECLOMETHASONE DIPROPRIATE BP Ibicar 50 Glenmark , India Inhalation Aerosol 50 mcg / Actuation POM Re E 01.03.2016- Market Exclusivity
28.02.2021 given to ADK Company
Pvt. Ltd.
232 P2371 BENZOIC ACID Emoderm Cream GlaxoSmithKline, India Cream 0.20% OTC R 05.07.2010 Registered by ADK
Company Pvt Ltd
233 P3563 BENZOIC ACID + SALICYLIC ACID BP Whitfield's Hovid Bhd. 121, Jalan Tunku Ointment 6% w/w + 3% w/w POM Re 08.09.2015 - Market Exclusivity
Abdul Rahman, 30010 Ipoh, 07.09.2020 given to My Chemist
Malaysia Wholesale
234 P3274 BETACAROTENE Naturalle Beta Upha Pharmaceutical Capsule 6 mg POM R 06.01.2015 Registered by Dial
Carotene Manufacturing (M) Sdn. Bhd., Trade and Travels Pte.
Malaysia Ltd.
235 P2801 BETAHISTINE DIHYDROCHLORIDE Menaril Incepta pharmaceuticals Tablet 8 mg POM R 26.08.2013 Registered by Dial
Limited, Bangladesh Trade and Travels Pte.
Ltd.
236 P849 BETAMETHASONE Beprogel HOE Pharmaceutical Topical Solution 0.064% w/v in 30ml POM R E Registered by Dial
Manufacturing (M) Sdn. Bhd., Trade and Travels Pte.
Malaysia Ltd.
237 P846 BETAMETHASONE Bepresone cream HOE Pharmaceutical Cream 0.064% w/w in 15g POM R E Registered by Dial
Manufacturing (M) Sdn. Bhd., Trade and Travels Pte.
Malaysia Ltd.
238 P845 BETAMETHASONE Bepresone HOE Pharmaceutical Topical Ointment 0.064% w/w in 15g POM R E Registered by Dial
Ointment Manufacturing (M) Sdn. Bhd., Trade and Travels Pte.
Malaysia Ltd.
239 P3751 BETAMETHASONE Axcel Kotra Pharma, Malaysia Cream 5 g 0.10% POM Re 30.08.2016 - Market Exclusivity
Betamethasone 29.08.2021 given to State Trading
Organization Plc.

240 P3754 BETAMETHASONE Axcel Kotra Pharma, Malaysia Cream 15 g 0.1% POM Re 30.08.2016 - Market Exclusivity
Betamethasone 29.08.2021 given to State Trading
Organization Plc.

241 P847 BETAMETHASONE + GENTAMICIN Beprogent Cream HOE Pharmaceutical Cream 0.064% w/w + 0.17%w/w in POM R Registered by Dial
SULPHATE Manufacturing (M) Sdn. Bhd., 15g Trade and Travels Pte.
Malaysia Ltd.
242 P3270 BETAMETHASONE + NEOMYCINE Betadrop -N Remington Ear/Eye/Nose 0.1% + 0.5% POM R 06.01.2015 Registered by ADK
Pharmaceuticals,Pakistan Drops Company Pvt Ltd

243 P848 BETAMETHASONE + SALICYLIC ACID Beprosalic HOE Pharmaceutical Topical Ointment 0.064%w/v + 3%w/w in 15g POM R E Registered by Dial
Ointment Manufacturing (M) Sdn. Bhd., Trade and Travels Pte.
Malaysia Ltd.
244 P1850 BETAMETHASONE + SALICYLIC ACID Beprosalic Lotion HOE Pharmaceutical Lotion 0.064%w/v+ 2%w/w in 30ml POM R E
Manufacturing (M) Sdn. Bhd.,
Malaysia
245 P2143 BETAMETHASONE BP Atnovate Arvind Remedies Ltd, India Cream 0.1% 15 BP POM R E

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Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 13 of 113 Authorized by:DG,MFDA
 246 P2002 BETAMETHASONE DIPROPIONATE USP + Camiderm S Liva Health Ltd ,India Ointment 0.64 mg/g + 30 mg/g POM R Registered by Green
SALICYLIC ACID IP Ointment 10 G Pharmacy
247 P4429 BETAMETHASONE-17 VALERATE + Uniflex-N Xepa-Soul Pattinson Cream 0.1% w/w + 0.5% w/w (15g) POM Re E 19.03.2019 - Market Exclusivity
NEOMYCIN SULPHATE (Malaysia) SDN. BHD. 1-5 18.03.2024 given to ADK
Cheng Industrial Estate, 75250 Pharmaceuticals
Melaka, Malaysia Company Pvt. Ltd.
248 P13 BETAXOLOL Betoptic S Alcon,Belgium Eye Drops 0.25% POM R 02.01.2000 Registered by ADK
Company Pvt Ltd
249 P2320 BIOTIN + VIT E Biotinex E Medopharm, India Capsule 250mcg + 50 mg POM R 28.02.2010 Registered by Green
Pharmacy
250 P3759 BISOPROLOL FUMARATE USP Bisocor 2.5 Square Formulations Film coated tablet 2.5 mg POM Re 06.09.2016 - Market Exclusivity
Ltd. Tangail, Bangladesh 05.09.2021 given to Dial Trade
and Travels Pte. Ltd.
251 P1916 BORIC ACID + BORAX Eye Glow Regular Duopharma (M) Sdn. Bhd., Eye Drops 1% w/v + 0.25% w/v OTC R
Malaysia
252 P1917 BORIC ACID + BORAX + Distilled Witch Hazel Eye Glow Plus Duopharma (M) Sdn. Bhd., Eye Drops 1.3% w/v + 0.3% w/v+5% v/v OTC R
Malaysia
253 P3499 BRIMONIDINE TARTRATE Alphaten Aristo Pharma Limited, Eye Drops 0.2% POM Re 19.05.2015- Market Exclusivity
Bangladesh 18.05.2020 given to Life Support
Pvt. Ltd.
254 P2026 BRINZOLAMIDE Azopt Alcon, USA Ophthalmic 10 mg/ ml POM R
Solution
255 P4440 BRINZOLAMIDE Azopt Alcon Couvreur N.V Rijksweg Ophthalmic 10 mg/ml (1.0% w/v) POM Re 19.03.2019 - Market Exclusivity
14, B-2870, Puurs, Belgium suspension 5ml 18.03.2024 given to ADK
Pharmaceutical
Company Pvt. Ltd.
256 P2859 BROMHEXINE Hosolvon Hovid Bhd, Malaysia Elixir 4mg/5 ml POM R 07.11.2013 Registered by GKT
Pharmacy
257 P3942 BROMHEXINE HYDROCHLORIDE Axcel Bromhexine Kotra Pharma (M) Sdn. Bhd., Tablet 8 mg POM Re 01.11.2016 - Market Exclusivity
1, 2, & 3 Jalan TTC 12, Cheng 31.10.2021 given to State Trading
Industrial Estate, 75250 Organization Plc.
Melaka, Malaysia

258 P4436 BROMHEXINE HYDROCHLORIDE Mucolix Xepa-Soul Pattinson Elixir 4mg/5ml (90ml) POM Re 19.03.2019 - Market Exclusivity
(Malaysia) SDN. BHD. 1-5 18.03.2024 given to ADK
Cheng Industrial Estate, 75250 Pharmaceuticals
Melaka, Malaysia Company Pvt. Ltd.
259 P3588 BROMHEXINE HYDROCHLORIDE BP Ekxine Pharmaniaga Manufacturing Tablet 8 mg POM Re 20.10.2015- Market Exclusivity
Berhad, 11A, Jalan P/1, 19..10.2020 given to Dial Trade
Kawasan Perusahaan Bangi, and Travels Pte. Ltd.
43650 Bandar Baru Bangi,
Selangor Darul Ehsan,
Malaysia

260 P2906 BUDESONIDE Budenase AQ Cipla India Nasal Spray 100 mcg POM R 18.02.2014 Registered by ADK
Company Pvt Ltd
261 P2908 BUDESONIDE Budenide HOE Pharmaceutical Nasal Spray 64 mcg POM R E 18.02.2014 Registered by Dial
Manufacturing (M) Sdn. Bhd., Trade and Travels Pte.
Malaysia Ltd.

MTG Division, MFDA Rec. Name: Approved Drug List

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Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 14 of 113 Authorized by:DG,MFDA
 262 P2751 BUDESONIDE BP Budesonide Glenmark , India Inhaler 200 mcg POM R 08.05.2013 Registered by ADK
(06.09.2017) Company Pvt Ltd
263 P2737 BUPIVACAINE HYDROCHLORIDE + Anawin 0.5% Neon Laboratories, India Injection 5 mg/ml Restricted for R 16.04.2013 Registerd by State
DEXTROSE Hospital use only Trading Organization
Plc.
264 P2736 BUPIVACAINE HYDROCHLORIDE + Anawin Heavy Neon Laboratories, India Injection 5 mg+ 80 mg in 1ml Restricted for R 16.04.2013 Registerd by State
DEXTROSE USP 0.5% Hospital use only Trading Organization
Plc.
265 P796 BUTENEFINE HCL Fintop Cream Glenmark , India Cream 1% POM R Registered by ADK
Company Pvt Ltd
266 P4340 CALAMINE BP + ZINC OXIDE BP Dermoplex Upha Pharmaceutical Cream 4% w/w + 3% w/w (25g) OTC Re 02.10.2018 - Market Exclusivity
Manufacturing (M) Sdn. Bhd. 01.10.2023 given to Dial Trade
Lot 2& 4, Jalan p/7, Section and Travels Pte. Ltd.
13, Bangi Industrial Estate,
43650, Bandar Baru Bangi,
Selangor Darul Ehsan,
Malaysia

267 P3993 CALCIPOTRIOL Dipsotrex Glenmark Pharmaceuticals Ointment 50 micrograms ( 0.005%w/v) POM Re 01.08.2017 - Market Exclusivity
Ltd.Plot No: S-7, Colvale 01.08.2022 given to ADK
Industrial Estate, Colvale, Pharmaceutical
Bardez, Goa-403513, India Company Pvt. Ltd.

268 P1476 CALCITRIOL Rocaltrol Roche, Switzerland Capsule 0.25 mcg POM R
269 P3147 CALCITRIOL BP Calcitriol Sai Mirra Innopharm Pvt Ltd, Capsule 0.25 mg POM R 19.08.2014 Registered by AMDC
India Pvt Ltd
270 P4132 CALCIUM , VITAMIN C , POTASSIUM Multivitamin + Sunlife Laboratories, Germany Effervescent 80 mg + 60 mg+ 40 mg + 30 OTC R 16.04.13 Registered by ADK
,MAGNESIUM ,NIACIN , VITAMIN E, Mineral Tablet mg + 18 m g+ 10 mg+ Acid 6 Company Pvt Ltd
PANTOTHENIC ACID , VITAMIN B , VITAMIN Effervescent Tablet mg + 62 mg + 1.6 mg + 1.4 mg
B2 , VITAMIN B1, FOLIC ACID, + 200μg + 150 μg +2 1 μg
BIOTIN,VITAMIN B 12
271 P4134 CALCIUM , VITAMIN D3 Calcium + Vitamin Sunlife Laboratories, Germany Tablet 500 mg + 2.5μg OTC R 16.04.13 Registered by ADK
D3 Tablet Company Pvt Ltd

272 P4175 Calcium + Vitamin C Sunlife Calcium + Sunlife Laboratories, Germany Tablet 300mg + 75 mg OTC R 16.04.13 Registered by ADK
Vitamin C Company Pvt Ltd
273 P2150 CALCIUM CARBONATE + COLECALCIFEROL Calciven 500 Arvind Remedies Ltd, India Tablet 1250 mg equivalent to POM R E
BP Element Calcium 500 mg,
Colecalciferol 250IU
274 P2688 CALCIUM CARBONATE + LACTOSE + SOYA Menosoy Sterling Lab, India. Tablet 150 mg + 256.70 + 50mg OTC R 28.01.2013 Registered by AMDC
ISOFLAVONE Pvt Ltd
275 P2429 CALCIUM CARBONATE + VITAMIND3 Calcivita Forte Mega Life Sciences Capsule 1500 mg + 200IU POM R Registered by ADK
Ltd,Thailand Company Pvt Ltd
276 P4150 CALCIUM CARBONATE ELEMENT CALCIUM, Indical Indi Pharma Pvt ltd, India for Suspension 150mg+25 mg + 1.5 mg + 200 OTC R 20.05.2014 Registered by AMDC
MAGNESIUM HYDROXIDE IP MAGNESIUM Wallace Pharmaceuticals, iu /5 ml Pvt Ltd
ZINC GLUCONAT ZINC VITAMIN D3 India

277 P1932 CALCIUM CITRATE USP + CHOLECALCIFEROL Milical Tablets Glenmark , India Tablet 1000 mg + 200 IU POM R E
USP

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Rev. No.: 02 Page 15 of 113 Authorized by:DG,MFDA
 278 P2393 CALCIUM CITRATE USP + MAGNESIUM CALCIPLUS MMC Health Care Ltd,India Tablet 1000 mg + 100 mg + 11 mg + OTC R 08.09.2010 Registered by Green
HYDROXIDE USP + ZINC SULPHATE 200 IU Pharmacy
MONOHYDRATE USP + VITAMIN D3
279 P4167 CALCIUM LACTATE GLUCONATE,CALCIUM Cavic C Incepta pharmaceuticals Tablet 1000mg +327 mg +500 mg OTC Re 24.03.2015 - Market Exclusivity
CARBONATE, ASCORBIC ACID Limited, Bangladesh 23.03.2020 given to Dial Trade
and Travels Pte. Ltd.
280 P3631 CANDESARTAN CILEXETIL Treatan PharmEvo (Private) Limited, Tablet 16 mg POM Re 19.01.2016- Market Exclusivity
At Plot # A-29, Northe 18.01.2021 given to Life Support
Western Industrial Zone, Port Pvt. Ltd.
Qasim, Karachi, Karachi-
75020, Pakistan

281 P3632 CANDESARTAN CILEXETIL Treatan PharmEvo (Private) Limited, Tablet 8 mg POM Re 19.01.2016- Market Exclusivity
At Plot # A-29, Northe 18.01.2021 given to Life Support
Western Industrial Zone, Port Pvt. Ltd.
Qasim, Karachi, Karachi-
75020, Pakistan

282 P3633 CANDESARTAN CILEXETIL Treatan PharmEvo (Private) Limited, Tablet 4 mg POM Re 19.01.2016- Market Exclusivity
At Plot # A-29, Northe 18.01.2021 given to Life Support
Western Industrial Zone, Port Pvt. Ltd.
Qasim, Karachi, Karachi-
75020, Pakistan

283 P1477 CAPECITABINE Xeloda Roche, Switzerland Tablet 150 mg POM R E

284 P2347 CAPSAICIN Menzza OA HOE Pharmaceutical Cream 0.025% OTC R 26.05.2010 Registered by Dial
Manufacturing (M) Sdn. Bhd., Trade and Travels Pte.
Malaysia Ltd.
285 P162 CAPTOPRIL Capoten GlaxoSmithKline, Pakistan Tablet 25 mg POM R Registered by ADK
Company Pvt Ltd
286 P3467 CAPTOPRIL USP Catoper Pharmix Laboratories Pakistan Tablet 25 mg POM Re 21.04.2015 - Market Exclusivity
20.04.2020 given to Life Support
Pvt. Ltd.
287 P1249 CARBAMAZEPINE Tegretol CR Novartis Pharmaceuticals UK Tablet 200 mg POM R E 02.02.2010 Registerd by State
Ltd UK/Norvartis Pharma AG, Trading Organization
Switzerland,Italy Plc.

288 P1262 CARBAMAZEPINE Tegretol Novartis Pharma, Italy Tablet 200 mg POM R E Registerd by State
Trading Organization
Plc.
289 P2658 CARBAMAZEPINE Tegretol 2% Delpharm Huningue S.A.S., Oral Liquid 100mg / 5ml POM R E 27.11.2012 Registered by
Huningue, France (For Mediquip Maldives
Norvatis Pharma AG, Basle, Pvt. Ltd.
Switzerland)
290 P2308 CARBOMER +HYPROMELLOSE Genteal Novartis Ophthalmics Eye Gel 22% + 3 % POM R 02.02.2010 Registerd by State
AG,Switzeland Trading Organization
Plc.

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 16 of 113 Authorized by:DG,MFDA
 291 P3949 CARVEDILOL Carvidex 6.25 Dr. Reddy's Laboratories Ltd., Film coated tablet 6.25 mg POM Re E 06.12.2016- Market Exclusivity
Survey No. 42, 45 & 46, 05.12.2021 given to State Trading
Bachupally - 500 090. A. P., Organization Plc.
INDIA
292 P3950 CARVEDILOL Carvidex 12.5 Dr. Reddy's Laboratories Ltd., Film coated tablet 12.5 mg POM Re 06.12.2016- Market Exclusivity
Survey No. 42, 45 & 46, 05.12.2021 given to State Trading
Bachupally - 500 090. A. P., Organization Plc.
INDIA
293 P3951 CARVEDILOL Carvidex 25 Dr. Reddy's Laboratories Ltd., Film coated tablet 25 mg POM Re 06.12.2016- Market Exclusivity
Survey No. 42, 45 & 46, 05.12.2021 given to State Trading
Bachupally - 500 090. A. P., Organization Plc.
INDIA
294 P1867 CARVEDILOL Carvas 12.5 Medley Ltd, India. Tablet 12.5mg POM R Registered by ADK
Company Pvt Ltd
295 P1877 CARVEDILOL Carvas 6.25 Medley Ltd, India. Tablet 6.25 mg POM R E
296 P164 CEFADROXIL Duricef Bristol Myers Squibb Pakistan Capsule 250 mg POM R E Registered by ADK
Company Pvt Ltd
297 P163 CEFADROXIL Duricef Bristol Myers Squibb Pakistan Oral Liquid 125mg/ 5ml POM R E Registered by ADK
Company Pvt Ltd
298 P2413 CEFADROXIL Cefadrox Aristo India Oral Liquid 125mg/ 5 ml POM R E 07.10.2010 Registered by ADK
Company Pvt Ltd
299 P2426 CEFADROXIL Cefadrox Kid Aristo India Tablet 250 mg POM R E 25.10.2010 Registered by ADK
Company Pvt Ltd
300 P2412 CEFADROXIL Cefadrox Aristo India Oral Liquid 250mg/ 5 ml POM R 07.10.2010 Registered by ADK
Company Pvt Ltd
301 P2414 CEFADROXIL IP Cefadrox Aristo India Tablet 500 mg POM R E 07.10.2010 Registered by ADK
Company Pvt Ltd
302 P1130 CEFADROXIL USP Zoxil 500 Medley Pharmaceuticals Ltd, Tablet 500mg POM R E Registered by ADK
India. Company Pvt Ltd
303 P1131 CEFADROXIL USP Zoxil 125 DT Medley Ltd, India. Tablet 125mg POM R E Registered by ADK
Company Pvt Ltd
304 P1132 CEFADROXIL USP Zoxil 250 DT Medley Ltd, India. Tablet 250mg POM R E Registered by ADK
Company Pvt Ltd
305 P1900 CEFADROXIL USP Stercef Sterling Lab, India Capsule 500mg POM R E Registered by AMDC
Pvt Ltd
306 P2167 CEFEPIME Maxicef 1 g Aristo India Injection 1g POM R
307 P2166 CEFEPIME Maxicef 500 Aristo India Injection 500 mg POM R
308 P3567 CEFEPIME HYDROCHLORIDE USP Hovid Sefepim Hovid Bhd. 121, Jalan Tunku Injection 1 gm/vial POM Re 08.09.2015 - Market Exclusivity
Abdul Rahman, 30010 Ipoh, 07.09.2020 given to My Chemist
Malaysia Wholesale
309 P2622 CEFEXIME USP Rite - O - Cef Micro Labs ltd Tablet 200 mg POM R E 18.09.2012 Registered by ADK
Company Pvt Ltd
310 P1134 CEFIXIME Cefo DT Medley Ltd, India. Tablet 100mg POM R E Registered by ADK
Company Pvt Ltd
311 P1135 CEFIXIME Cefo DT Medley Ltd, India. Tablet 200mg POM R E Registered by ADK
Company Pvt Ltd
312 P1133 CEFIXIME Cefo Oral liquid Medley Ltd, India. Powder for Oral 50mg/5ml POM R E Registered by ADK
Solution Company Pvt Ltd

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Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 17 of 113 Authorized by:DG,MFDA
 313 P2531 CEFIXIME Tocef General Pharmacueticals Capsule 200mg POM R E 29.08.2011 Registered by Dial
Ltd,Bangladesh Trade and Travels Pte.
Ltd.
314 P2685 CEFIXIME Ciftaze Sterling Lab, India. Tablet (DT) 200 mg POM R E 28.01.2013 Registered by AMDC
Pvt Ltd
315 P2686 CEFIXIME Ciftaze Sterling Lab, India. Tablet (DT) 100 mg POM R E 28.01.2013 Registered by AMDC
Pvt Ltd
316 P2036 CEFIXIME + LACTOBACILLUS Cefo L - Oral liquid Medley Ltd, India. Dry Powder Oral 50 mg/5ml POM R E
Liquid
317 P2033 CEFIXIME + LACTOBACILLUS Cefo L - 50 Medley Ltd, India. Tablet (Disperible) 50 mg + 60 million spores POM R

318 P2035 CEFIXIME + LACTOBACILLUS Cefo L - 200 Medley Ltd, India. Tablet (Disperible) 200mg + 60 POM R
million spores
319 P2034 CEFIXIME + LACTOBACILLUS Cefo L - 100 Medley Ltd, India. Tablet (Disperible) 100 mg + 60 POM R
million spores
320 P4277 CEFIXIME TRIHYDRATE (ANHYDROUS) Trifix PT. Dankos Farma JI. Rawa Oral Suspension 100mg/5ml POM Re 17.04.2018 - Market Exclusivity
Gatel Block III S, Kav. 36-38, (Dry syrup) 16.04.2023 given to State Trading
Kawasan Industri Pulo Gadung Organization Plc.
Jakata 13930, Indonesia.

321 P4278 CEFIXIME TRIHYDRATE (ANHYDROUS) Trifix 200 PT. Dankos Farma JI. Rawa Film coated tablet 200mg POM Re E 17.04.2018 - Market Exclusivity
Gatel Block III S, Kav. 37-38, 16.04.2023 given to State Trading
Kawasan Industri Pulo Gadung Organization Plc.
Jakata 13930, Indonesia.

322 P3762 CEFIXIME TRIHYDRATE USP Cef-3 Square Pharmaceuticals Ltd., Capsule 200 mg POM Re E 06.09.2016 - Market Exclusivity
Kaliakoir, Bangladesh 05.09.2021 given to Dial Trade
and Travels Pte. Ltd.
323 P3517 CEFIXIME USP Inoxime-200 Atoz Pharmaceuticals, India Tablet 200 mg POM Re E 19.05.2015- Market Exclusivity
18.05.2020 given to My Chemist
Wholesale
324 P2896 CEFOTAXIME Zetaxim Innova Captab Pvt Ltd, Injection 1 g IP POM R E 05.03.2014 Registered by Life
India/Nitin Lifes Support Pvt Ltd
Sciences,India
325 P2895 CEFOTAXIME IP Zetaxim Shivek Labs Ltd,India Injection 500mg POM R E 05.03.2014 Registered by Life
Support Pvt Ltd
326 P1733 CEFOTAXIME USP Zetaxim Wockhardt, India Injection 500mg POM R E Registered by Life
Support Pvt Ltd
327 P2813 CEFOTAXIME USP Zetaxim Wockhardt India,C/o San Injection 1g POM R E 26.08.2013 Registered by Life
Laboratories ,India Support Pvt Ltd
328 P2397 CEFPODOXIME Ximeprox Incepta pharmaceuticals Tablet 200 mg POM R 02.09.2010 Registered by Dial
Limited, Bangladesh Trade and Travels Pte.
Ltd.
329 P2646 CEFPODOXIME Kefodime 200 Medley Ltd, India. Tablet 200 mg POM R 02.10.2012 Registered by ADK
Company Pvt Ltd
330 P2161 CEFPODOXIME Monocef -O 100 Aristo India Tablet 100 mg POM R
331 P2162 CEFPODOXIME Monocef -O 100 Aristo India Oral Liquid 100 mg/5ml POM R
332 P2163 CEFPODOXIME Monocef -O 200 Aristo India Tablet 200 mg POM R
333 P2645 CEFPODOXIME IP Kefodime 100 Medley Ltd, India. Tablet 100 mg POM R 02.10.2012 Registered by ADK
Company Pvt Ltd

MTG Division, MFDA Rec. Name: Approved Drug List

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 334 P2518 CEFPODOXIME USP Kefodime Medley Ltd, India. Oral Liquid 50 mg /5ml POM R 23.06.2011 Registered by ADK
Company Pvt Ltd
335 P165 CEFRADINE Velosef Bristol Myers Squibb Pakistan Capsule 250 mg POM R Registered by ADK
Company Pvt Ltd
336 P166 CEFRADINE Velosef GlaxoSmithKline, Pakistan Injection 500 mg POM R Registered by ADK
Company Pvt Ltd
337 P167 CEFRADINE Velosef GlaxoSmithKline, Pakistan Injection 250 mg POM R Registered by ADK
Company Pvt Ltd
338 P168 CEFRADINE Velosef GlaxoSmithKline, Pakistan Injection 1000 mg POM R Registered by ADK
Company Pvt Ltd
339 P169 CEFRADINE Velosef GlaxoSmithKline, Pakistan Oral Liquid 125mg/ 5ml POM R Registered by ADK
Company Pvt Ltd
340 P717 CEFTAZIDIME Fortum GlaxoSmithKline, Italy,India Injection 1 gm POM R E 05.06.13 Registerd by State
Trading Organization
Plc.
341 P719 CEFTAZIDIME Fortum GlaxoSmithKline, Italy,India Injection 500 mg POM R E 05.06.13 Registerd by State
Trading Organization
Plc.
342 P3622 CEFTAZIDIME PENTAHYDRATE USP EvoZid PharmEvo (Private) Limited, Injection (dry 1 g/vial POM Re E 17.11.2015- Market Exclusivity
Plot # A-29, North Western powder) 16.11.2020 given to Life Support
Industrial Zone, Port Qasim, Pvt. Ltd.
Karachi-75020, Pakistan

343 P3623 CEFTAZIDIME PENTAHYDRATE USP EvoZid PharmEvo (Private) Limited, Injection (dry 500 mg/vial POM Re E 17.11.2015- Market Exclusivity
Plot # A-29, North Western powder) 16.11.2020 given to Life Support
Industrial Zone, Port Qasim, Pvt. Ltd.
Karachi-75020, Pakistan

344 P2656 CEFTAZIDIME USP Ceftazidime Swiss Parentrals,India Injection 500 mg POM R E 27.11.2012 Registered by Life
Support Pvt Ltd
345 P2655 CEFTAZIDIME USP Ceftazidime Swiss Parentrals,India Injection 1gm POM R E 27.11.2012 Registered by Life
Support Pvt Ltd
346 P65 CEFTRIAXONE Monocef Aristo India Injection 250 mg /ml POM R E Registered by ADK
Company Pvt Ltd
347 P3761 CEFTRIAXONE Ceftron Square Pharmaceuticals, Injection 1g/Vial POM Re E 06.09.2016 - Market Exclusivity
Bangladesh 05.09.2021 given to Dial Trade
and Travels Pte. Ltd.
348 P3689 CEFTRIAXONE SODIUM Monocef Aristo Pharmaceuticals Pvt Injection 1G POM Re E 01.03.2016- Market Exclusivity
Ltd, Inida 28.02.2021 given to ADK Company
Pvt. Ltd.
349 P2892 CEFTRIAXONE SODIUM IP Powercef 1g Zeiss Pharma Ltd, Unit II India Injection 1g/vial POM R E 05.03.2014 Registered by Life
Support Pvt Ltd
350 P2893 CEFTRIAXONE SODIUM IP Powercef 500 Zeiss Pharmaceuticals Pvt Ltd, Injection 500mg POM R E 05.03.2014 Registered by Life
India Support Pvt Ltd
351 P2894 CEFTRIAXONE SODIUM IP Powercef 250 Zeiss Pharma Ltd, Unit II India Injection 250mg POM R E 05.03.2014 Registered by Life
Support Pvt Ltd
352 P2312 CEFTRIAXONE SODIUM USP Powercef 500 Wockhardt, India Injection 500mg POM R E Registered by Life
Support Pvt Ltd
353 P3208 CEFTRIAXONE SODIUM USP Hoftrex Hovid Bhd, Malaysia Injection 1 g per 10ml POM R E 06.11.2014 Registered by GKT
Pharmacy

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Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 19 of 113 Authorized by:DG,MFDA
 354 P2310 CEFTRIAXONE SODIUM USP Powercef 250 Wockhardt, India Injection 250 mg POM R E Registered by Life
Support Pvt Ltd
355 P2812 CEFTRIAXONE SODIUM USP Powercef 1g Wockhardt India,C/o San Injection 1g POM R E 26.08.2013 Registered by Life
Laboratories Support Pvt Ltd
356 P4337 CEFTRIAXONE SODIUM USP Vaxcel Ceftriaxone Kotra Pharma (M) Sdn. Bhd., Injection 500mg/vial POM Re E 02.10.2018 - Market Exclusivity
1, 2 & 3 Jalan TTC 12, Cheng 01.10.2023 given to State Trading
Industrial Estate, 75250, Organization Plc.
Malaka, Malaysia

357 P4338 CEFTRIAXONE SODIUM USP Vaxcel Ceftriaxone Kotra Pharma (M) Sdn. Bhd., Injection 1g/vial POM Re E 02.10.2018 - Market Exclusivity
1, 2 & 3 Jalan TTC 12, Cheng 01.10.2023 given to State Trading
Industrial Estate, 75250, Organization Plc.
Malaka, Malaysia

358 P2267 CEFUROXIME Forcef 750 Aristo India Injection 750 mg POM R E Registered by ADK
Company Pvt Ltd
359 P2271 CEFUROXIME Forcef 250 Aristo India Tablet 250 mg POM R E Registered by ADK
Company Pvt Ltd
360 P2272 CEFUROXIME Forcef 500 Aristo India Tablet 500 mg POM R E Registered by ADK
Company Pvt Ltd
361 P658 CEFUROXIME Zinacef GlaxoSmithKline, Italy Injection 250mg/vial POM R E 23.05.2010 Registered by ADK
Company Pvt Ltd
362 P659 CEFUROXIME Zinacef GlaxoSmithKline, Italy Injection 750mg/vial POM R E 23.05.2010 Registered by ADK
Company Pvt Ltd
363 P661 CEFUROXIME Zinacef GlaxoSmithKline, Italy Injection 1.5g/vial POM R E 23.05.2010 Registered by ADK
Company Pvt Ltd
364 P2436 CEFUROXIME Forcef 125 Aristo India Tablet 125 mg POM R E 23.11.2010 Registered by ADK
Company Pvt Ltd
365 P2654 CEFUROXIME Cefuroxime Swiss Parentrals,India Injection 750 mg POM R E 27.11.2012 Registered by Life
Support Pvt Ltd
366 P662 CEFUROXIME AXETIL Zinnat GlaxoSmithKline , UK Tablet 250 mg POM R E 10.09.2013 Registered by ADK
Company Pvt Ltd
367 P2209 CEFUROXIME AXETIL Zinnat GlaxoSmithKline , UK Tablet 500 mg POM R E Registered by ADK
Company Pvt Ltd
368 P2844 CEFUROXIME AXETIL Zinnat GlaxoSmithKline , UK Oral Liquid 125 mg/5ml POM R E 10.09.2013 Registered by ADK
Company Pvt Ltd
369 P798 CEFUROXIME AXETIL Altacef 500 Tablet Glenmark , India Tablet 500mg POM R E Registered by ADK
Company Pvt Ltd
370 P2192 CEFUROXIME AXETIL USP Pulmocef Micro Labs ltd Tablet 500 mg POM R E Registered by ADK
Company Pvt Ltd
371 P2193 CEFUROXIME AXETIL USP Pulmocef Micro Labs ltd Tablet 250 mg POM R E Registered by ADK
Company Pvt Ltd
372 P2811 CEFUROXIME AXETIL USP Kefstar Wockhardt, India Tablet 250 mg POM R E 26.08.2013 Registered by Life
Support Pvt Ltd
373 P2809 CEFUROXIME AXETIL USP Kefstar Wockhardt, India Oral Liquid 125mg/ 5 ml POM R E 26.08.2013 Registered by Life
Support Pvt Ltd
374 P3456 CEFUROXIME AXETIL USP Kilbac Incepta pharmaceuticals Tablet 250 mg POM Re E 24.03.2015 - Market Exclusivity
Limited, Bangladesh 23.03.2020 given to Dial Trade
and Travels Pte. Ltd.
375 P1878 CEFUROXIME AXETIL USP Ceurox 250 Medley Ltd, India. Tablet 250mg POM R E

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Rev. No.: 02 Page 20 of 113 Authorized by:DG,MFDA
 376 P2142 CEFUROXIME AXETIL USP Ceurox 500 Medley Ltd, India. Tablet 500 mg POM R E
377 P797 CEFUROXIME AXETIL USP Altacef 250 Tablet Glenmark , India Tablet 250mg POM R E Registered by ADK
Company Pvt Ltd
378 P2810 CEFUROXIME AXETIL USP Kefstar Wockhardt, India Tablet 500 mg POM R E 26.08.2013 Registered by Life
Support Pvt Ltd
379 P2247 CEFUROXIME SODIUM Pulmocef Micro Labs ltd Injection 750 mg POM R E Registered by ADK
Company Pvt Ltd
380 P4333 CEFUROXIME SODIUM (Eqv. CEFUROXIME) Vaxcel Cefuroxime Kotra Pharma (M) Sdn. Bhd., Injection 750mg/vial POM Re E 02.10.2018 - Market Exclusivity
1, 2 & 3 Jalan TTC 12, Cheng 01.10.2023 given to State Trading
Industrial Estate, 75250, Organization Plc.
Malaka, Malaysia

381 P3249 CEFUROXIME USP Hovid Cmaxid Nector Life Sciences Ltd ,India Injection 1.5 gm POM R E 06.01.2015 Registered by GKT
Pharmacy
382 P3250 CEFUROXIME USP Hovid Cmaxid Nector Life Sciences Ltd ,India Injection 750 mg POM R E 06.01.2015 Registered by GKT
Pharmacy
383 P4280 CELECOXIB Celox-R Renata Limited, (Milk Vita Capsule 200mg POM R 17.04.2018 Registered
Road, Section - VII, Mirpur,
Dhaka-1216,) Bangladesh

384 P2437 CEPHALEXIN Cephadex Cipla India Capsule 250 mg POM R E 23.11.2010 Registered by ADK
Company Pvt Ltd
385 P147 CEPHALEXIN Blucef p Blue Cross Laboratories India Tablet 125 mg POM R E Registered by ADK
Company Pvt Ltd
386 P2494 CEPHALEXIN Cafalexin Arvind Remedies Ltd, India Capsule 250 mg POM R 23.02.2011 Registered by Green
Pharmacy
387 P2514 CEPHALEXIN Sepexin 500 Lyka BDR India Capsule 500 mg POM R 23.06.2011 Registered by Green
Pharmacy
388 P2697 CEPHALEXIN Cefex Micro Labs ltd Capsule 250 mg POM R 28.01.2013 Registered by ADK
Company Pvt Ltd
389 P2683 CEPHALEXIN Cephast Sterling Lab, India. Capsule 500 mg POM R 28.01.2013 Registered by AMDC
Pvt Ltd
390 P2684 CEPHALEXIN Cephast Sterling Lab, India. Oral Liquid 125mg/5 ml POM R 28.01.2013 Registered by AMDC
Pvt Ltd
391 P1902 CEPHALEXIN Cephast - 250 Sterling Lab, India Capsule 250mg POM R E Registered by AMDC
Capsules Pvt Ltd
392 P771 CEPHALEXIN Ceporex GlaxoSmithKline, Bangladesh Oral Liquid 125mg/5ml 100ml POM R E 10.09.2013 Registerd by State
Trading Organization
Plc.
393 P1924 CEPHALEXIN Uphalexin 250 Upha Pharmaceutical Oral Liquid 250mg/5ml POM R E
Granules Manufacturing (M) Sdn. Bhd.,
Malaysia
394 P2573 CEPHALEXIN Safexin- 125 Saga Laboratories, India Oral Liquid 125 mg / 5 ml POM R 06.03.2012 Registered by Dial
Trade and Travels Pte.
Ltd.
395 P2015 CEPHALEXIN Nufex Suspension General Pharmacueticals Oral Liquid 125mg/5 ml POM R E
Ltd,Bangladesh
396 P3552 CEPHALEXIN Uphalexin Upha Pharmaceutical Capsule 250 mg POM Re 25.08.2015- Market Exclusivity
Manufacturing (M) Sdn. Bhd., 27.08.2020 given to Dial Trade
Malaysia and Travels Pte. Ltd.

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 21 of 113 Authorized by:DG,MFDA
 397 P3553 CEPHALEXIN Uphalexin Upha Pharmaceutical Capsule 500 mg POM Re 25.08.2015- Market Exclusivity
Manufacturing (M) Sdn. Bhd., 24.08.2020 given to Dial Trade
Malaysia and Travels Pte. Ltd.
398 P3583 CEPHALEXIN Cephalexin Pharmaniaga, Malaysia Capsule 500 mg POM Re 06.10.2015- Market Exclusivity
05.10.2020 given to Dial Trade
and Travels Pte. Ltd.
399 P2698 CEPHALEXIN BP Cefex Micro Labs ltd Capsule 500 mg POM R 28.01.2013 Registered by ADK
Company Pvt Ltd
400 P3607 CEPHALEXIN IP Cephadex Okasa Pharma Pvt. Ltd. L-2, Dry Syrup 125 mg/ 5 ml POM R 06.10.2015 Registered
Additional MIDC, Satara 415
004, Maharashtra State, India

401 P867 CETEARYL ALCOHOL + DIMETHICONE + Ellgy Plus HOE Pharmaceutical Cream 25g POM R Registered by Dial
ISOPROPYL MYRISTATE + PORTULACA Manufacturing (M) Sdn. Bhd. Trade and Travels Pte.
OLERACEA EXTRACT + SODIUM LACTATE + Lot 10, Jalan Sultan Mohd. 6, Ltd.
GLYCEROL + ETHYLPARABEN+ IMIDUREA+ Bandar Sultan Suleiman
LAVENDER OIL+ METHYLPARABEN + 42000 Port Klang, Malaysia
PHENOXYETHANOL + PROPYLENE GLYCOL +
PROPYLPARABEN

402 P3145 CETIRIZINE CETIRIZINE Cassel Research Laboratories, Tablet 10 mg OTC R E 19.08.2014 Registered by My
DEHYDROCHLORID India Chemist Wholesale
E
403 P2384 CETIRIZINE Allercet Micro Labs ltd Oral Liquid 5mg/5 ml OTC R E 16.08.2010 Registered by ADK
Company Pvt Ltd
404 P2489 CETIRIZINE Citri MMC Health Care Ltd,India Oral Liquid 5 mg/5ml OTC R E 23.02.2011 Registered by Green
Pharmacy
405 P2793 CETIRIZINE Alergo Pharmix Laboratorie, Pakistan Oral Liquid 5mg/5 ml OTC R E 05.06.2013 Registered by Life
Support Pvt Ltd
406 P2821 CETIRIZINE Ricam Tablet Ankur Drugs and Pharma Tablet 10 mg OTC R E 26.08.2013 Registered
Limited, India
407 P2682 CETIRIZINE Hister Sterling Lab, India. Oral Liquid 5mg/5 ml OTC R E 28.01.2013 Registered by AMDC
Pvt Ltd
408 P1901 CETIRIZINE Hister Sterling Lab, India Tablet 10mg OTC R E Registered by AMDC
Pvt Ltd
409 P2820 CETIRIZINE Ricam Oral liquid Ankur Drugs and Pharma Oral Liquid 5 mg/ 5 ml OTC R E 26.08.2013 Registered by GKT
Limited, India Pharmacy
410 P1896 CETIRIZINE Alatrol Square Pharmaceuticals, Tablet 10 mg OTC R E
Bangladesh
411 P2148 CETIRIZINE Arizin 10 Arvind Remedies Ltd, India Tablet 10mg OTC R E

412 P2158 CETIRIZINE Medocetinax Medopharm, India Tablet 10mg OTC R E

413 P2008 CETIRIZINE Alatrol Oral liquid Square Pharmaceuticals, Oral Liquid 5 mg/ 5 ml OTC R E
Bangladesh
414 P3475 CETIRIZINE Alergo Pharmix Laboratories Pakistan Tablet 10 mg OTC Re E 21.04.2015 - Market Exclusivity
20.04.2020 given to Life Support
Pvt. Ltd.
415 P2199 CETIRIZINE BP Allercet 10 Micro Labs ltd Tablet 10 mg OTC R E Registered by ADK
Company Pvt Ltd

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 22 of 113 Authorized by:DG,MFDA
 416 P148 CETIRIZINE BP Ekon D T Blue Cross Laboratories India Tablet 10 mg OTC R E Registered by ADK
Company Pvt Ltd
417 P1136 CETIRIZINE BP Oncet Medley Ltd, India. Tablet 10 mg OTC R E Registered by ADK
Company Pvt Ltd
418 P3747 CETIRIZINE DIHYDROCHLORIDE Axcel Cetirizine Kotra Pharma, Malaysia Syrup 5 mg/5ml OTC Re E 30.08.2016 - Market Exclusivity
29.08.2021 given to State Trading
Organization Plc.

419 P3947 CETIRIZINE DIHYDROCHLORIDE Axcel Cetirizine Kotra Pharma (M) Sdn. Bhd., Tablet 10 mg OTC Re E 01.11.2016 - Market Exclusivity
1, 2, & 3 Jalan TTC 12, Cheng 31.10.2021 given to State Trading
Industrial Estate, 75250 Organization Plc.
Melaka, Malaysia

420 P3601 CETIRIZINE HYDROCHLORIDE BP Allercure Aeon Formulations Pvt. Ltd., Film Coated Tablet 10 mg OTC Re E 20.10.2015 - Market Exclusivity
India 19.10.2020 given to Moonima
Medicals
421 P3723 CETIRIZINE HYDROCHLORIDE BP Alerid Cipla Ltd, India Oral Liquid 5mg/5ml (30ml) OTC R E 17.05.2016 Registered
422 P4435 CHLORAMPHENICOL Xepanicol Xepa-Soul Pattinson Eye Drops 0.5% w/w (5ml) POM Re E 19.03.2019 - Market Exclusivity
(Malaysia) SDN. BHD. 1-5 18.03.2024 given to ADK
Cheng Industrial Estate, 75250 Pharmaceuticals
Melaka, Malaysia Company Pvt. Ltd.
423 P48 CHLORAMPHENICOL Asclor eye oint Ambalal Sarabhai Eye Ointment 1% POM R E Registered by ADK
India/Assence Pharma Pvt Ltd Company Pvt Ltd

424 P3562 CHLORAMPHENICOL BP Chloramphenicol Hovid Bhd. 121, Jalan Tunku Capsule 250 mg POM Re E 08.09.2015 - Market Exclusivity
Abdul Rahman, 30010 Ipoh, 07.09.2020 given to My Chemist
Malaysia Wholesale
425 P803 CHLORAMPHENICOL BP + ANHYDROUS Candibiotic Glenmark , India Ear Drops 5% + 0.025% + 1% + 2% POM R 16.08.2010 Registered by ADK
BECLAMETHASONE DIPROPIONATE BP + Company Pvt Ltd
CLOTRIMAZOLE USP + LIDOCAINE HCL BP

426 P2112 CHLORAMPHENICOL USP Optomycin Ashford Laboratories Ltd Eye Drops 5 mg POM R E
427 P2679 CHLORDIAZEPOXIDE Ebrium East West Pharma,India Tablet 10 mg INTERNATIONALLY R E 22.01.2013 Registerd by State
CONTROLLED Trading Organization
(PSYCHOTROPIC) Plc.
428 P3031 CHLORHEXIDINE Bacidin Xepa-Soul Pattinson Concentrated 5% w/v (500ml) OTC Re E 09.04.2019 - Market Exclusivity
(Malaysia) SDN. BHD. 1-5 Solution 08.04.2024 given to ADK
Cheng Industrial Estate, 75250 Pharmaceuticals
Melaka, Malaysia Company Pvt. Ltd.
429 P3107 CHLORPHENIRAMINE Horamine Hovid Bhd, Malaysia Oral Liquid 4mg/5 ml BP OTC R 20.05.2014 Registered by GKT
Pharmacy
430 P647 CHLORPHENIRAMINE Piriton Oral liquid GlaxoSmithKline, SriLanka Oral Liquid 2 mg/5ml OTC R E 21.03.2010 Registered by ADK
Company Pvt Ltd
431 P2729 CHLORPHENIRAMINE Horamine Hovid Bhd, Malaysia Tablet 4 mg OTC R E 05.03.2013 Registered by GKT
Pharmacy
432 P2169 CHLORPHENIRAMINE Chlorphenamine Medopharm, India Oral Liquid 2mg/5ml OTC R

433 P646 CHLORPHENIRAMINE + NH4CL Piriton Exp GlaxoSmithKline, SriLanka Oral Liquid 2mg +100mg OTC R E 03.02.2010 Registered by ADK
Company Pvt Ltd

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 23 of 113 Authorized by:DG,MFDA
 434 P2323 CHLORPHENIRAMINE + Piriton DM GlaxoSmithKline, SriLanka Oral Liquid 2mg + 10 mg POM R 21.03.2010 Registered by ADK
DEXTROMETHORPHAN Company Pvt Ltd
435 P3587 CHLORPHENIRAMINE MALEATE Chlorpheniramine Pharmaniaga Manufacturing Tablet 4 mg OTC Re 20.10.2015- Market Exclusivity
Berhad, 11A, Jalan P/1, 19..10.2020 given to Dial Trade
Kawasan Perusahaan Bangi, and Travels Pte. Ltd.
43650 Bandar Baru Bangi,
Selangor Darul Ehsan,
Malaysia

436 P3957 CHLORPHENIRAMINE MALEATE Axcel Kotra Pharma (M) Sdn. Bhd., Syrup 4 mg / 5 ml POM Re 06.12.2016- Market Exclusivity
Chlorpheniramine- 1, 2, & 3 Jalan TTC 12, Cheng 05.12.2021 given to State Trading
4 Industrial Estate, 75250 Organization Plc.
Melaka, Malaysia

437 P3593 CHLORPHENIRAMINE MALEATE BP + Tuscure MMC Healthcare Ltd. India Oral Liquid 2mg + 5mg +10mg /5ml POM Re 27.10.2015- Market Exclusivity
PHENYLEPHRINE HYDROCHLORIDE BP + 26.10.2020 given to Green
DEXTROMETHORPHAN HYDROBROMIDE BP Pharmacy Godown

438 P96 CHLORPHENIRAMINE MALEATE + Corex D Astron Limited, Sri Lanka Oral Liquid 2 mg +15 mg /5 ml POM R E 01.04.2014 Registerd by State
DEXTROMETHORPHEN HYDROBROMIDE Trading Organization
Plc.
439 P3264 CHLORPHENIRAMINE MALEATE + Contus Paediatric Stedman Pharmaceuticals, Oral Liquid 1 mg (BP)+ 5 mg(BP)+10 mg POM Re 20.01.2015 - Market Exclusivity
PHENYLEPHRINE HYDROCHLORIDE + Linctus India (BP)/5ml 19.01.2020 given to AMDC Pvt.
DEXTROMETHORPHEN HYDROBROMIDE Ltd.

440 P3265 CHLORPHENIRAMINE MALEATE + Contus Stedman Pharmaceuticals, Tablet 2mg (BP) + 5 mg(BP)+10 mg POM Re 20.01.2015 - Market Exclusivity
PHENYLEPHRINE HYDROCHLORIDE + CoughTablet India (BP) 19.01.2020 given to AMDC Pvt.
DEXTROMETHORPHEN HYDROBROMIDE Ltd.

441 P3693 CHOLECALCIFEROL JusDee Stedman Pharmaceuticals, Granules 60,000 iu/Sachet POM Re E 01.03.2016- Market Exclusivity
India ( in Sachet ) 28.02.2021 given to AMDC Pvt.
Ltd.
442 P3694 CHOLECALCIFEROL JusDee Stedman Pharmaceuticals, Oral Drops 400 iu/ml POM Re E 01.03.2016- Market Exclusivity
India 28.02.2021 given to AMDC Pvt.
Ltd.
443 P3155 CHOLINE SALICYLATE AND OrreGel HOE Pharmaceutical Oral Gel 8.7% w/w + 0.1% w/w OTC R 19.08.2014 Registered by Dial
CETYLPYRIDINIUM CHLORIDE Manufacturing (M) Sdn. Bhd., Trade and Travels Pte.
Malaysia Ltd.
444 P930 CINNARIZINE Stugeron J&J, India Tablet 25 mg POM Re E 08.09.2015 - Market Exclusivity
07.09.2020 given to Mediquip
Maldives Pvt. Ltd.
445 P3955 CINNARIZINE Axcel Cinnarizine Kotra Pharma (M) Sdn. Bhd., Tablet 25 mg POM Re E 06.12.2016- Market Exclusivity
1, 2, & 3 Jalan TTC 12, Cheng 05.12.2021 given to State Trading
Industrial Estate, 75250 Organization Plc.
Melaka, Malaysia

446 P3464 CIPROFIBRATE Glenlipid Glenmark , India Tablet 100 mg BP POM Re 24.03.2015 - Market Exclusivity
23.03.2020 given to ADK Company
Pvt. Ltd.

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 24 of 113 Authorized by:DG,MFDA
 447 P2341 CIPROFLOXACIN Ciproglen Glenmark , India Tablet 500 mg POM R E 13.05.2010 Registered by ADK
Company Pvt Ltd
448 P149 CIPROFLOXACIN Cebran Blue Cross Laboratories India Tablet 250 mg USP POM R E Registered by ADK
Company Pvt Ltd
449 P150 CIPROFLOXACIN Cebran Blue Cross Laboratories India Tablet 500 mg USP POM R E Registered by ADK
Company Pvt Ltd
450 P2382 CIPROFLOXACIN Microflox 250 Micro Labs ltd Tablet 250 mg USP POM R E 16.08.2010 Registered by ADK
Company Pvt Ltd
451 P2383 CIPROFLOXACIN Microflox 500 Micro Labs ltd Tablet 500mg USP POM R E 16.08.2010 Registered by ADK
Company Pvt Ltd
452 P2291 CIPROFLOXACIN Q- Bact Saga Laboratories, India Tablet 250 mg POM R E Registered by Dial
Trade and Travels Pte.
Ltd.
453 P2292 CIPROFLOXACIN Q- Bact Saga Laboratories, India Tablet 500 mg POM R E Registered by Dial
Trade and Travels Pte.
Ltd.
454 P1109 CIPROFLOXACIN Ciprofloxacin Marck Bio Sciences Ltd,India Injection 200mg/100ml (USP) in normal POM R E Each
Injection U. S. P. saline Shipment
should be
accompanied
by the batch
certificates

455 P2493 CIPROFLOXACIN Iflos 500 MMC Health Care Ltd,India Tablet 500 mg POM R 23.02.2011 Registered by Green
Pharmacy
456 P245 CIPROFLOXACIN Ciplox Cipla India Ear/Eye Drops 0.30% POM R E 17.12.2009 Registered by ADK
Company Pvt Ltd
457 P1895 CIPROFLOXACIN Ciprocin Square Formulations Tablet 500 mg POM R E
Ltd. Tangail, Bangladesh
458 P2043 CIPROFLOXACIN Supraflox Khandelwal Laboratories Pvt Tablet 500 mg POM R E
Ltd
459 P2125 CIPROFLOXACIN Ecoflox 250 Medley Ltd, India. Tablet 250 mg POM R E
460 P1965 CIPROFLOXACIN Ciprocin 250 Square Pharmaceuticals, Tablet 250 mg POM R E
Bangladesh
461 P2621 CIPROFLOXACIN Microflox Eye Micro Labs ltd Ophthalmic 0.30% POM R E 18.09.2012 Registered by ADK
Drops Solution Company Pvt Ltd
462 P3605 CIPROFLOXACIN HCL USP Ciplox 500 Cipla Ltd. Mumbai Central Film-coated Tablet 500 mg POM R E 06.10.2015 Registered
Mumbai-400 008, India

463 P2720 CIPROFLOXACIN BP Quintor Torrent Pharmaceuticals, Tablet 500 mg POM R E 19.02.2013 Registered by Life
India Support Pvt Ltd
464 P2124 CIPROFLOXACIN BP Ecoflox 500 Medley Ltd, India. Tablet 500 mg POM R E
465 P3990 CIPROFLOXACIN HYDROCHLORIDE USP Cipromen CCL Pharmaceuticals (Pvt) Ltd, Film coated tablet 250 mg POM Re E 01.08.2017 - Market Exclusivity
62-Industrial estate, Kot 01.08.2022 given to State Trading
Lakhpat, Lahore, Pakistan Organization Plc.

466 P3991 CIPROFLOXACIN HYDROCHLORIDE USP Cipromen CCL Pharmaceuticals (Pvt) Ltd, Film coated tablet 500 mg POM Re E 01.08.2017 - Market Exclusivity
62-Industrial estate, Kot 01.08.2022 given to State Trading
Lakhpat, Lahore, Pakistan Organization Plc.

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 25 of 113 Authorized by:DG,MFDA
 467 P4357 CIPROFLOXACIN HYDROCHLORIDE USP Ciloxan Alcon- Convreur, N.V. Ophthalmic 0.3% (3mg)/ml (5ml) POM Re E 16.10.2018 - Market Exclusivity
Rijksweg 14, B-2870 Puurs, Solution 15.10.2023 given to ADK
Belgium Pharmaceutical
Company Pvt. Ltd.
468 P113 CIPROFLOXACIN IP Ciprofloxacin Baxter Ltd, India. Injection 200mg /100ml POM R E Each Registered by ADK
Shipment Company Pvt Ltd
should be
accompanied
by the batch
certificates

469 P1903 CIPROFLOXACIN IP Ciprost - 250 Sterling Lab, India Tablet 250mg POM R E Registered by AMDC
Pvt Ltd
470 P1904 CIPROFLOXACIN IP Ciprost - 500 Sterling Lab, India Tablet 500mg POM R E Registered by AMDC
Pvt Ltd
471 P2441 CIPROFLOXACIN USP Floximed Medopharm, India Tablet 500 mg POM R E 22.10.2010 Registered by Green
Pharmacy
472 P2262 CIPROFLOXACIN USP Abact Ambalal Sarabhai Tablet 250mg POM R E Registered by ADK
India/Assence Pharma Pvt Ltd Company Pvt Ltd

473 P2040 CIPROFLOXACIN USP Novaflox Ashford Laboratories Ltd Eye Drops 3. 00 mg POM R E
474 P3476 CIPROFLOXACIN USP Bionip Pharmix Laboratories Pakistan Tablet 500 mg POM Re E 21.04.2015 - Market Exclusivity
20.04.2020 given to Life Support
Pvt. Ltd.
475 P3763 CIPROFLOXACINE HCL Ciprocin Square Pharmaceuticals, Eye/Ear Drops 0.3% POM Re E 06.09.2016 - Market Exclusivity
Bangladesh 05.09.2021 given to Dial Trade
and Travels Pte. Ltd.
476 P4147 CITROUS BIOFLAVONOIDS+ GOLDCARE Vitabiotics Capsule 16 mg +3mg +10mg + 10 mcg OTC R 18.02.14 Registered by Life
BETACAROTEINE + GINKO BILOBA + +200 mg + 80mg + 12mg + Support Pvt Ltd
VITAMIN D+ VITAMIN E + VITAMIN C + 20mg +500 mcg + 20 mcg+ 10
THIAMINE + NIACINE + VITAMIN B + FOLIC mg+ 6 mg+75 mg + 15 mg +
ACID + VITAMIN B12+ PANTOTHENIC ACID 130 mcg + 2 mg + 1 mg + 1mg
+ IRON + MGNESIUM + ZINC + IODINE + + 100 mcg + 150 mg
MANGANESE +COPPER + BORON +
CHROMIUM + SELENIUM

477 P2877 CLARITHROMYCIN Maclar Glenmark , India Tablet 500 mg POM R E 07.01.2014 Registered by ADK
Company Pvt Ltd
478 P30 CLARITHROMYCIN Clarithro Alembic Pharmaceuticals Tablet 250mg POM R E Registered by Dial
Limited India Trade and Travels Pte.
Ltd.
479 P2792 CLARITHROMYCIN Efelide Pharmix Laboratorie, Pakistan Oral Liquid 125mg/5 ml POM R E 05.06.2013 Registered by Life
Support Pvt Ltd
480 P2219 CLARITHROMYCIN Klaribact 250 Merck Limited, Pakistan Tablet 250 mg POM R E Registered by ADK
Company Pvt Ltd
481 P2220 CLARITHROMYCIN Klaribact 500 Merck Limited, Pakistan Tablet 500 mg POM R E Registered by ADK
Company Pvt Ltd
482 P2221 CLARITHROMYCIN Klaribact Dry Oral Merck Limited, Pakistan Oral Liquid 125 mg/5ml POM R E Registered by ADK
liquid Company Pvt Ltd

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 26 of 113 Authorized by:DG,MFDA
 483 P1971 CLARITHROMYCIN Remac Square Pharmaceuticals, Tablet 250 mg POM R E
Bangladesh
484 P2121 CLARITHROMYCIN Maclar Glenmark , India Tablet 250 mg (IP) POM R E
485 P3579 CLARITHROMYCIN Neo-Klar CCL Pharmaceuticals, Oral Liquid 125 mg/ 5 ml POM Re E 06.10.2015- Market Exclusivity
Pakistan 05.10.2020 given to State Trading
Organization Plc.

486 P2248 CLARITHROMYCIN USP Clariwin Micro Labs ltd Tablet 250 mg POM R E Registered by ADK
Company Pvt Ltd
487 P2749 CLINDAMYCIN Acnegon Gel Zyg Pharma, India Gel 1% POM R 08.05.2013 Registerd by State
Trading Organization
Plc.
488 P1836 CLINDAMYCIN T3 Mycin gel HOE Pharmaceutical Gel 1.2% w/w POM R E
Manufacturing (M) Sdn. Bhd.,
Malaysia
489 P1837 CLINDAMYCIN T3 Mycin lotion HOE Pharmaceutical Lotion 1.2% w/w in 30ml POM R E
Manufacturing (M) Sdn. Bhd.,
Malaysia
490 P3958 CLINDAMYCIN PHOSPHATE Axcel Clindamycin Kotra Pharma (M) Sdn. Bhd., Topical Solution 1% w/v POM Re 06.12.2016- Market Exclusivity
1% 1, 2, & 3 Jalan TTC 12, Cheng 05.12.2021 given to State Trading
Industrial Estate, 75250 Organization Plc.
Melaka, Malaysia

491 P3684 CLINDAMYCIN PHOSPHATE + Vagid-CL Bliss GVS Pharma Limited, Vaginal 100mg + 200mg POM Re 03.05.2016 - Market Exclusivity
CLOTRIMAZOLE India Suppositories 02.05.2021 given to Green
Pharmacy Godown
492 P2680 CLOBAZAM Czam East West Pharma,India Tablet 5 mg INTERNATIONALLY R 22.01.2013 Registerd by State
CONTROLLED Trading Organization
(PSYCHOTROPIC) Plc.
493 P2681 CLOBAZAM Czam East West Pharma,India Tablet 10mg INTERNATIONALLY R 22.01.2013 Registerd by State
CONTROLLED Trading Organization
(PSYCHOTROPIC) Plc.
494 P850 CLOBETASOL Cloderm cream HOE Pharmaceutical Cream 0.05%w/w in 15g POM R E Registered by Dial
Manufacturing (M) Sdn. Bhd., Trade and Travels Pte.
Malaysia Ltd.
495 P851 CLOBETASOL Cloderm scalp HOE Pharmaceutical Scalp application 0.05% w/w in 30ml POM R E Registered by Dial
application Manufacturing (M) Sdn. Bhd., Trade and Travels Pte.
Malaysia Ltd.
496 P852 CLOBETASOL Cloderm HOE Pharmaceutical Ointment 0.05%w/w in 15g POM R E Registered by Dial
Manufacturing (M) Sdn. Bhd., Trade and Travels Pte.
Malaysia Ltd.
497 P811 CLOBETASOL BP Powercort Glenmark , India Cream 0.05% in 15g POM R E Registered by ADK
Company Pvt Ltd
498 P3940 CLOBETASOL PROPIONATE Axcel Clobetasol Kotra Pharma (M) Sdn. Bhd., Cream 0.05% w/w (15g tube) POM Re 01.11.2016 - Market Exclusivity
1, 2, & 3 Jalan TTC 12, Cheng 31.10.2021 given to State Trading
Industrial Estate, 75250 Organization Plc.
Melaka, Malaysia

MTG Division, MFDA Rec. Name: Approved Drug List

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Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 27 of 113 Authorized by:DG,MFDA
 499 P3941 CLOBETASOL PROPIONATE Axcel Clobetasol Kotra Pharma (M) Sdn. Bhd., Cream 0.05% w/w (5g tube) POM Re 01.11.2016 - Market Exclusivity
1, 2, & 3 Jalan TTC 12, Cheng 31.10.2021 given to State Trading
Industrial Estate, 75250 Organization Plc.
Melaka, Malaysia

500 P3954 CLOBETASOL PROPIONATE Axcel Clobetasol Kotra Pharma (M) Sdn. Bhd., Ointment 0.05% w/w (15g tube) POM Re 06.12.2016- Market Exclusivity
1, 2, & 3 Jalan TTC 12, Cheng 05.12.2021 given to State Trading
Industrial Estate, 75250 Organization Plc.
Melaka, Malaysia

501 P1998 CLOBETASOL PROPIONATE + MICONAZOLE Clop MG Cream Liva Health Ltd ,India Cream 0.050% w/w + 2.00%(IP) + POM R Registered by Green
NITRATE+ GENTAMYCIN SULPHATE 10 G 0.100% W/W(IP) Pharmacy

502 P2229 CLOBETASOL USP Steriderm-S Micro Labs ltd Cream 0.05% POM R E Registered by ADK
Company Pvt Ltd
503 P1997 CLOBETASOL USP Clop Cream 10 G Liva Health Ltd ,India Cream 0.050% w/w POM R E Registered by Green
Pharmacy
504 P2897 CLOBETASOLE PROPIONATE + ZINC Zincoderm Apex Laboratories, India Cream 0.050% w/w + 1% w/w POM R 18.02.2014 Registered by ADK
SULPHATE Company Pvt Ltd
505 P2899 CLOBETASOLE PROPIONATE + ZINC Zincoderm-G Apex Laboratories, India Cream 0.050% w/w + 1% w/w + POM R 18.02.2014 Registered by ADK
SULPHATE + GENTAMYCIN SULPHATE 0.100% Company Pvt Ltd
506 P2898 CLOBETASOLE PROPIONATE + ZINC Zincoderm-M Apex Laboratories, India Cream 0.050% w/w + 1% w/w + 2% POM R 18.02.2014 Registered by ADK
SULPHATE +MICONAZOLE NITRATE Company Pvt Ltd
507 P1839 CLOBETASONE U-closone HOE Pharmaceutical Cream 0.05% POM R
Manufacturing (M) Sdn. Bhd.,
Malaysia
508 P1838 CLOBETASONE U-closone HOE Pharmaceutical Topical Ointment 0.05% POM R
Manufacturing (M) Sdn. Bhd.,
Malaysia
509 P2238 CLOBETASONE BP Sterisone 0.05% Micro Labs ltd Cream 0.05% POM R Registered by ADK
Company Pvt Ltd
510 P4069 CLOMIFENE CITRATE Ovulet Renata Limited, (Milk Vita Tablet 50mg POM Re E 03.10.2017 - Market Exclusivity
Road , Section - VII, Mirpur, 02.10.2022 given to ADK
Dhaka- 1216,) Bangladesh. Pharmaceutical
Company Pvt. Ltd.
511 P2669 CLONAZEPAM Clopam East West Pharma, India Tablet 2 mg INTERNATIONALLY R 22.01.2013 Registerd by State
CONTROLLED Trading Organization
(PSYCHOTROPIC) Plc.
512 P2670 CLONAZEPAM Clopam East West Pharma, India Tablet 0.5mg INTERNATIONALLY R 22.01.2013 Registerd by State
CONTROLLED Trading Organization
(PSYCHOTROPIC) Plc.
513 P3281 CLONAZEPAM Zapiz Intus Pharmaceuticals Tablet 0.25 mg INTERNATIONALLY R 10.02.2015 Product registered
CONTROLLED based on a special
(PSYCHOTROPIC) request from a
clinician
514 P2288 CLOPIDOGREL Aplatin Saga Laboratories, India Tablet 75 mg POM R E Registered by Dial
Trade and Travels Pte.
Ltd.
515 P2273 CLOPIDOGREL Cloflow 75 Aristo India Tablet 75 mg IP POM R E Registered by ADK
Company Pvt Ltd

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 28 of 113 Authorized by:DG,MFDA
 516 P2440 CLOPIDOGREL Medovix 75 Medopharm, India Tablet 75 mg POM R E 22.10.2010 Registered by Green
Pharmacy
517 P1893 CLOPIDOGREL Anclog Tablet Square Pharmaceuticals, Tablet 75 mg POM R E
Bangladesh
518 P1137 CLOPIDOGREL BISULFATE Platfree Medley Ltd, India. Tablet 75mg USP POM R E Registered by ADK
Company Pvt Ltd
519 P2661 CLOPIDOGREL BISULFATE Clopitab CCL Pharmaceuticals, Tablet 75mg POM R E 27.11.2012 Registered by ADK
Pakistan Company Pvt Ltd
520 P2231 CLOPIDOGREL BISULFATE Plagerine 75 Micro Labs ltd Tablet 75 mg USP POM R E Registered by ADK
Company Pvt Ltd
521 P3665 CLOPIDOGREL BISULFATE Plagril Dr Reddy`s Laboratories,India Tablet 75 mg POM Re E 21.01.2016 - Market Exclusivity
20.01.2021 given to State Trading
Organization Plc.

522 P3931 CLOPIDOGREL BISULFATE Apo-Clopidogrel Apotex Inc., 150 Signet Drive Tablet 75 mg POM Re E 01.11.2016 - Market Exclusivity
Toronto (Weston), Ontario, 31.10.2021 given to Treetop
Canada M9L 1T9, Canada Health Pvt. Ltd.

523 P2706 CLOPIDOGREL BISULFATE IP Deplatt Torrent Pharmaceuticals, Tablet 75 mg POM R E 19.02.2013 Registered by Life
India Support Pvt Ltd
524 P3141 CLOPIDOGREL BISULFATE USP Clogrel Cassel Research Laboratories, Tablet 75 mg POM R E 19.08.2014 Registered by My
India Chemist Wholesale

525 P816 CLOTRIMAZOLE Candid Glenmark , India Mouth Paint 1% w/v in 15ml POM R E Registered by ADK
Company Pvt Ltd
526 P818 CLOTRIMAZOLE Candid V 3 Glenmark , India Tablet (Vaginal) 200 mg POM R E Registered by ADK
Company Pvt Ltd
527 P819 CLOTRIMAZOLE Candid V 6 Glenmark , India Tablet (Vaginal) 100 mg POM R E Registered by ADK
Company Pvt Ltd
528 P853 CLOTRIMAZOLE Candazole HOE Pharmaceuticals Sdn. Cream 1% w/w (15g) POM Re E 19.03.2019 - Market Exclusivity
Bhd., Lot 10, Jalan Sultan 18.03.2024 given to Dial Trade
Mohamed. 6, Bandar Sultan and Travels Pte. Ltd.
Suleiman, 42000 Port Klang,
Malaysia

529 P854 CLOTRIMAZOLE Candazole HOE Pharmaceutical Ointment 1% POM R E Registered by Dial
Manufacturing (M) Sdn. Bhd., Trade and Travels Pte.
Malaysia Ltd.
530 P855 CLOTRIMAZOLE Candazole Lotion HOE Pharmaceutical Lotion 1%w/v in 10ml POM R E Registered by Dial
Manufacturing (M) Sdn. Bhd., Trade and Travels Pte.
Malaysia Ltd.
531 P2380 CLOTRIMAZOLE Surfaz Dusting Franco Indian Remedies Pvt Powder 1% w/w OTC R 25.07.2010 Registered by ADK
Powder Ltd India Company Pvt Ltd
532 P1945 CLOTRIMAZOLE Surfaz Vaginal Franco Indian Remedies Pvt Tablet (Vaginal) 100 mg POM R E 25.07.2010 Registered by ADK
Tablets Ltd India Company Pvt Ltd
533 P814 CLOTRIMAZOLE Candid Glenmark , India Topical Solution 1% POM R E Registered by ADK
(lotion) Company Pvt Ltd

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 29 of 113 Authorized by:DG,MFDA
 534 P3196 CLOTRIMAZOLE Candazole V HOE Pharmaceutical Cream (Vaginal) 10% POM R E 06.11.2014 Registered by Dial
Cream Manufacturing (M) Sdn. Bhd., Trade and Travels Pte.
Malaysia Ltd.
535 P815 CLOTRIMAZOLE Candid Glenmark , India Cream 1% POM R E Registered by ADK
Company Pvt Ltd
536 P4295 CLARITHROMYCIN Claritrox 500 SM Pharmaceuticals Sdn. Bhd. Fim coated tablet 500mg POM Re 15.05.2018 - Market Exclusivity
(218620-M) Lot 88, Sungai 14.05.2023 given to Green
Petani, Industrial Estate, Pharmacy Godown
08000 Sungai Petani, Kedah,
Malaysia
537 P2390 CLOTRIMAZOLE SURFAZ Franco Indian Remedies Pvt Cream 1.000% POM R 25.07.2010 Registered by Green
Ltd India Pharmacy
538 P804 CLOTRIMAZOLE USP + BECLOMETASONE Candiderm Glenmark , India Cream 1% + 0.025% + 01% in 15gm POM R 16.08.2010 Registered by ADK
BP + GENTAMYCIN Company Pvt Ltd
539 P856 CLOTRIMAZOLE + HYDROCORTISONE Candacort HOE Pharmaceutical Cream 1% w/w + 1% w/w POM R Registered by Dial
Manufacturing (M) Sdn. Bhd., Trade and Travels Pte.
Malaysia Ltd.
540 P821 CLOTRIMAZOLE + SELENIUM SULFIDE Candid TV Glenmark , India Topical Suspension 1% + 2.5 % POM R 16.10.2010 Registered by ADK
Company Pvt Ltd
541 P4293 Clotrimazole BP Clozole SM Pharmaceuticals Sdn. Bhd. Ointment 10mg (1% w/w) (15g tube) POM Re 15.05.2018 - Market Exclusivity
(218620-M) Lot 88, Sungai 14.05.2023 given to Green
Petani, Industrial Estate, Pharmacy Godown
08000 Sungai Petani, Kedah,
Malaysia
542 P4380 CLOTRIMAZOLE BP + TRIAMCINOLONE Flurocomb SM Pharmaceuticals SDN BHD Cream 1% w/w (10mg) + 0.1% w/w POM Re 23.10.2018 - Market Exclusivity
ACETONIDE BP (218620-M) Lot 88, Sungai (1mg) 22.10.2023 given to Green
Petani, Industrial Estate, Pharmacy Godown
08000 Sungai, Petani, Kedah, Only
Malaysia
543 P812 CLOTRIMAZOLE USP Candid Glenmark , India Ear Drops 1% POM R E Registered by ADK
Company Pvt Ltd
544 P817 CLOTRIMAZOLE USP Candid V Glenmark , India Gel 2% POM R E Registered by ADK
Company Pvt Ltd
545 P2389 CLOTRIMAZOLE USP + BETAMETHASONE SURFAZ -SN Franco Indian Remedies Pvt Cream 1% + 0.05% + 0.5% POM R 25.07.2010 Registered by Green
USP + NEOMYCIN Ltd India Pharmacy
546 P778 CODEINE + PARACETAMOL Panadeine GlaxoSmithKline, Australia Tablet 8mg + 500mg POM R Registered by ADK
Company Pvt Ltd
547 P95 CODEINE PHOSPHATE + Corex Astron Limited, Sri Lanka Oral Liquid 10mg + 4mg /5ml NATIONALLY R E 01.04.2010 Registerd by State
CHLORPHENIRAMINE MELEATE CONTROLLED Trading Organization
(PSYCHOTROPIC) Plc.
548 P4149 COLECALCIFEROL + THIAMINE + VITAMIN + Zincovit D Apex Laboratories Pvt Ltd, Oral Drops 2500 iu +200 iu+ 1 mg + 2.5 iu OTC R 18.02.14 Registered by ADK
RIBOFLAVIN + SODIUM PHOSPHATE + India + 0.1mg + 0.50 mg + 10 mg+ 50 Company Pvt Ltd
PYRIDOXINE HCL + DEXPANTHENOL + mcg + 13.3mg/ml
NICOTINAMIDE + POTASSIUM IODINE +
ZINC + SULPHATE HEPTAHYDRATE

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 30 of 113 Authorized by:DG,MFDA
 549 P3136 COMPOUND SODIUM LACTATE (SODIUM Flagolact Axa Parentrals limited Injection 0.320gm + 0.600 gm + 0.040 POM R E 19.08.2014 Registered by Medlab
LACTATE + SODIUM CHLORIDE (BP) + gm + 0.027 gm in 100ml Diagnostics Pvt. Ltd.
POTASSIUM CHLORIDE BP + CALCIUM
CHLORIDE DIHYDRATE BP

550 P2498 CO-TRIMOXAZOLE (SULFAMETHOXAZOLE) Arcotrim Arvind Remedies Ltd, India Oral Liquid 40 mg + 200 mg in 5ml POM R 23.02.2011 Registered by Green
BP + TRIMETHOPRIM) Pharmacy

551 P523 CO-TRIMOXAZOLE (SULFAMETHOXAZOLE) Cotrimoxazole FDC India Oral Liquid 40 mg + 200 mg in 5ml POM R E
BP + TRIMETHOPRIM) BP

552 P4133 CRANBERRY FRUIT POWDER , VITAMIN C Cranberry + Sunlife Laboratories, Germany Lozenges 450 mg + 40 mg OTC R 16.04.13 Registered by ADK
Vitamin C Company Pvt Ltd
Lozenges
553 P2041 CROMOLYN SODIUM USP Cromax-2 Ashford Laboratories Ltd Eye Drops 20 mg POM R
554 P857 CROTAMITON A- Bite Cream HOE Pharmaceutical Cream 10% W/W in 15g OTC R E Registered by Dial
Manufacturing (M) Sdn. Bhd., Trade and Travels Pte.
Malaysia Ltd.
555 P1242 CYCLOSPORIN Sandimmun Neoral Catalent Germany Eberbach Capsule 50mg POM R E Registerd by State
GmbH/ Novartis Pharma AG, Trading Organization
Switzerland Plc.

556 P1243 CYCLOSPORIN Sandimmun Neoral Catalent Germany Eberbach Capsule 25mg POM R E Registerd by State
GmbH/ Novartis Pharma AG, Trading Organization
Switzerland Plc.

557 P1241 CYCLOSPORIN Sandimmun Neoral Catalent Germany Eberbach Capsule 100mg POM R E
GmbH/ Novartis Pharma AG,
Switzerland

558 P1312 CYCLOSPORIN USP Panimun Bioral Panacea Biotec Ltd, India. Capsule 50mg POM R E

559 P1311 CYCLOSPORIN USP Panimun Bioral Panacea Biotec Ltd, India. Capsule 25mg POM R E

560 P1310 CYCLOSPORIN USP Panimun Bioral Panacea Biotec Ltd, India. Capsule 100mg POM R E

561 P1309 CYCLOSPORIN USP Panimun Bioral Panacea Biotec Ltd, India. Oral Liquid 100mg in 1ml POM R E

562 P2212 CYPROHEPTADINE Cypro Medopharm, India Tablet 4 mg POM R E Registered by Green
Pharmacy
563 P252 CYPROHEPTADINE Ciplactin Cipla India Tablet 4 mg POM R 05.05.2009 Registered by ADK
Company Pvt Ltd
564 P251 CYPROHEPTADINE Ciplactin Cipla India Oral Liquid 2 mg/5ml POM R 05.05.2009 Registered by ADK
Company Pvt Ltd
565 P253 DANAZOL Danogen Cipla India Capsule 100 mg POM R E 17.12.2009 Registered by ADK
Company Pvt Ltd
566 P254 DANAZOL Danogen Cipla India Capsule 200 mg POM R E 17.12.2009 Registered by ADK
Company Pvt Ltd

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 31 of 113 Authorized by:DG,MFDA
 567 P2233 DEFERASIROX Asunra 100 Novartis Pharma AG, Tablet 100 mg POM R Registered by
Switzerland Mediquip Maldives
Pvt. Ltd.
568 P2232 DEFERASIROX Asunra 400 Novartis Pharma AG, Tablet 400 mg POM R Registered by
Switzerland Mediquip Maldives
Pvt. Ltd.
569 P4283 DEFERASIROX Jadenu 360 Novartis Pharma Stein AG, Film coated tablet 360mg POM Re 17.04.2018 - Market Exclusivity
Stein, Switzerland (Novartis 16.04.2023 given to Mediquip
Pharma Stein AG Maldives Pvt. Ltd.
Schaffhauserstrass 4332 stein
Switzerland)
570 P4284 DEFERASIROX Jadenu 180 Novartis Pharma Stein AG, Film coated tablet 180mg POM Re 17.04.2018 - Market Exclusivity
Stein, Switzerland (Novartis 16.04.2023 given to Mediquip
Pharma Stein AG Maldives Pvt. Ltd.
Schaffhauserstrass 4332 stein
Switzerland)
571 P4285 DEFERASIROX Jadenu 90 Novartis Pharma Stein AG, Film coated tablet 90mg POM Re 17.04.2018 - Market Exclusivity
Stein, Switzerland (Novartis 16.04.2023 given to Mediquip
Pharma Stein AG Maldives Pvt. Ltd.
Schaffhauserstrass 4332 stein
Switzerland)
572 P1980 DEFERIPRONE Kelfer 500 Cipla India Capsule 500 mg POM R 23.05.2005
573 P2055 DEFERIPRONE Ferriprox Apotex Europe Ltd/ Srini Tablet 500 mg POM R
Pharmaceuticals, India
574 P1257 DEFEROXAMINE (desferrioxamine) Desferal Wasserburger Injection 500 mg/ml POM R E 02.02.2010 Registered by
Arzneimittelwerk Mediquip Maldives
GmbH,Germany Pvt. Ltd.
575 P2580 DEFEROXAMINE (desferrioxamine) Talifer Lemery ,S.A DE C.V, Mexico Powder for 500 mg POM R 05.06.2012 Registered by
Injection Mediquip Maldives
(Lyophilized) Pvt. Ltd.
576 P3962 DEFEROXAMINE MESILATE DEMOFERIDON DEMO SA, Pharmaceutical Injection 500mg / vial POM R 14.03.2017 Registered
Industry, 21st km National (Lyophilised
Road Athens-Lamis, GR-145 powder )
68 Krioneri, Attica, Greece.

577 P2297 DESLORATADINE Lorinex 5 Micro Labs ltd Tablet 5 mg OTC R E Registered by ADK
Company Pvt Ltd
578 P3556 DESLORATADINE Lorinex -DT 2.5 Micro Labs Limited, 92, Uncoated 2.5 mg OTC Re 25.08.2015- Market Exclusivity
SIPCOT, HOSUR-635 126 INDIA dispersible tablet 24.08.2020 given to ADK Company
Pvt. Ltd.
579 P3557 DESLORATADINE Lorinex -DT 5 Micro Labs Limited, 92, Uncoated 5 mg OTC Re 25.08.2015- Market Exclusivity
SIPCOT, HOSUR-635 126 INDIA dispersible tablet 24.08.2020 given to ADK Company
Pvt. Ltd.
580 P4000 DESOGESTREL + ETHINYLESTRADIOL Desolon Renata Limited, Milk Vita Tablet 0.15 mg + 0.03 mg POM R 15.08.2017 Registered
Road , Section - VII, Mirpur,
Dhaka- 1216, Bangladesh.

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 32 of 113 Authorized by:DG,MFDA
 581 P16 DEXAMETHASONE Maxidex Alcon Couvreur N.V Rijksweg Eye Drops 0.1% POM Re E 19.03.2019 - Market Exclusivity
14, B-2870, Puurs, Belgium 18.03.2024 given to ADK
Pharmaceutical
Company Pvt. Ltd.
582 P4358 DEXAMETHASONE + NEOMYCIN SULPHATE Maxitrol Alcon Couvreur, N.V Rigsweg Ophthalmic (1ml) 0.1% + 3500 IU/ml + POM Re 16.10.2018 - Market Exclusivity
+ POLYMYXIN B SULPHATE 14, B-2870 Puurs, Belgium Suspension 6000 IU/ml (5ml) 15.10.2023 given to ADK
Pharmaceutical
Company Pvt. Ltd.
583 P2110 DEXAMETHASONE USP + NEOMYCIN USP Dexoptic-N Eye Ashford Laboratories Ltd Eye Drops 1 mg + 3mg POM R
Drops
584 P2536 DEXTOANHYDROUS+POTASIUM CHLORIDE+ EP Baxter Ltd, India. Injection 5.0g+ 0.13g+0.026g+0.32g POM R Each
DIBASIC POTASIUM PHOSPHATE+SODIUM +0.031g+0.021 g in 100ml Shipment
ACETATE+MAGNESIUM CHLORIDE+SODIUM should be
METABISULPHATE accompanied
by the batch
certificates

585 P4471 DEXTRAN 70 + HYPROMELLOSE Tears Naturale II Alcon Couvreur N.V Rijksweg Eye Drops 1.0mg/ml (0.1%w/v) + POM Re E 09.04.2019 - Market Exclusivity
14, B-2870, Puurs, Belgium 0.3mg/ml (0.3%w/v) 15ml 08.04.2024 given to ADK
Pharmaceuticals
Company Pvt. Ltd.
586 P18 DEXTRAN+HYPROMELLOSE Tears Naturale Alcon, Singapore Eye Drops 70 0.1%+0.3% POM R 13.06.2010 Registered by ADK
Company Pvt Ltd
587 P1866 DEXTROMETHORPHAN BP + New Tuxuril Medley Ltd, India. Oral Liquid 10 mg +5 mg + 5 mg in 10ml POM R Registered by ADK
HYDROBROMIDE BP + PHENYLEPHRINE HCL Company Pvt Ltd
BP + MENTHOL USP

588 P1948 DEXTROMETHORPHAN HCL BP + Grilinctus Oral Wardex Pharmacueticals Pvt Oral Liquid 5 mg + 2.5 mg + 50 mg + 60 mg POM R
CHLORPHENIRAMINE MALEATE BP + liquid Ltd, India
GUAIPHENESIN BP + AMOMONIUM
CHLORIDE
589 P2402 DEXTROMETHORPHAN HCL BP + Exil D Oral liquid Medopharm, India Oral Liquid 10 mg + 5 mg + 2mg in 5ml POM R 30.09.2010 Registered by Green
PHENYLEPHERINE HCL BP + Pharmacy
CHLORPHENAMINE MELEATE BP
590 P4350 DEXTROMETHORPHAN HYDROBROMIDE Tussidex Forte Xepa-Soul Pattinson Linctus 15mg/5ml POM Re 23.10.2018 - Market Exclusivity
(Malaysia) SDN. BHD. 1-5 (120ml) 22.10.2023 given to ADK
Cheng Industrial Estate, 75250 Pharmaceutical
Melaka, Malaysia Company Pvt. Ltd.
591 P549 DEXTROSE Dextrose 5% Fresenius Kabi, India Injection 5% POM R E Each
Shipment
should be
accompanied
by the batch
certificates

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 33 of 113 Authorized by:DG,MFDA
 592 P550 DEXTROSE Dextrose 10% Fresenius Kabi, India Injection 10% POM R E Each
Shipment
should be
accompanied
by the batch
certificates

593 P115 DEXTROSE Glucose Baxter Ltd, India. Injection 25% POM R E Each Registered by ADK
Intravenous Shipment Company Pvt Ltd
Infusion B. P. (25% should be
W/V) accompanied
by the batch
certificates

594 P117 DEXTROSE HYDROUS+ SODIUM Dianeal PD-2 Baxter Ltd, India. Solution (Didalysis) 2.5g+538+448mg+25.7 POM R Each Registered by ADK
CHLORIDE+CALCIUM mg+5.08 Shipment Company Pvt Ltd
CHLORIDE+MAGNESIUM CHORIDE should be
accompanied
by the batch
certificates

595 P1110 DEXTROSE BP Glucose Marck Bio Sciences Ltd,India Injection 5% w/v POM R E Each
Intravenous Shipment
Infusion B. P. (5% should be
W/V) accompanied
by the batch
certificates

596 P114 DEXTROSE BP Glucose Baxter Ltd, India. Injection 5% w/v POM R E Each Registered by ADK
Intravenous Shipment Company Pvt Ltd
Infusion B. P. (5% should be
W/V) accompanied
by the batch
certificates

597 P1111 DEXTROSE NORMAL SALINE (SODIUM Sodium Chloride Marck Bio Sciences Ltd,India Injection 0.9% W/V+5% W/V POM R E Each
CHLORIDE +DEXTROSE) BP 0.9% and Dextrose Shipment
5% should be
accompanied
by the batch
certificates

598 P116 DEXTROSE NORMAL SALINE (SODIUM Sodium Chloride Baxter Ltd, India. Injection 0.9% W/V+5% W/V POM R E Each Registered by ADK
CHLORIDE +DEXTROSE) BP 0.9% and Dextrose Shipment Company Pvt Ltd
5% should be
accompanied
by the batch
certificates

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 34 of 113 Authorized by:DG,MFDA
 599 P3135 DEXTROSE USP Flagodext - 25 Axa Parentrals limited Injection 25% w/v in 100ml POM R E 19.08.2014 Registered by Medlab
Each Diagnostics Pvt. Ltd.
Shipment
should be
accompanied
by the batch
certificates

600 P3138 DEXTROSE USP Flagodext - 5 Axa Parentrals limited Injection 5% in 100ml POM R E 19.08.2014 Registered by Medlab
Each Diagnostics Pvt. Ltd.
Shipment
should be
accompanied
by the batch
certificates

601 P2667 DIAIZEPAM Diacalm East West Pharma,India Tablet 10 mg INTERNATIONALLY R 22.01.2013 Registerd by State
CONTROLLED Trading Organization
(PSYCHOTROPIC) Plc.
602 P2668 DIAZEPAM Diacalm East West Pharma,India Tablet 5 mg INTERNATIONALLY R 22.01.2013 Registerd by State
CONTROLLED Trading Organization
(PSYCHOTROPIC) Plc.
603 P2407 DIBASIC CALCIUM PHOSPHATE + CALCIUM Calcivita Mega Life Sciences Capsule 150mg + 50 mg + 2500 IU + OTC R 06.10.2010 Registered by ADK
CARBONATE + VITAMIN A + VITAMIN D3 Ltd,Thailand 400 IU Company Pvt Ltd

604 P2605 DICLFENAC SODIUM Clofenac SR Hovid Bhd, Malaysia Tablet 100 mg POM R 10.07.2012 Registered by GKT
Pharmacy
605 P2007 DICLOFENAC Clofenac Gel Square Pharmaceuticals, Gel 10 mg/ gm OTC R
Bangladesh
606 P3686 DICLOFENAC DIETHLMINE + LINSEE OIL Lofnac Bliss GVS Pharma Limited, Topical Gel 1.16% + 3% + 10% + 5% POM Re 01.03.2016- Market Exclusivity
+METHYL SALICYLATE + MENTHOL India 28.02.2021 given to Green
Pharmacy Godown
607 P2145 DICLOFENAC DIETHYLAMINE BP Aflamin Gel Arvind Remedies Ltd, India Gel 1.16% w/w OTC R

608 P2699 DICLOFENAC DIETHYLAMINE BP + LINSEED Divon Gel Micro Labs Limited, 67/68A, Gel 1.16% w/w + 1.0 w/w + 3.00 POM R 28.01.2013 Registered by ADK
OIL _ METHYL SALICYLATE BP + MENTHOL + 3rd Phase, Peenya, Bangalore- w/w + 10.00 w/w + 5.00% w/w Company Pvt Ltd
BENZOYL ALCOHOL BP 560 058, INDIA

609 P2001 DICLOFENAC DIETHYLAMINE BP + OLEUM + Flemigel -AF 30 G Liva Health Ltd ,India Ointment 1.16% +3.00 % W/w + 10.00% POM R Registered by Green
METHYLSALICYLATE IP W/W Pharmacy
610 P321 DICLOFENAC DIETHYLAMMONIUM Cofenac Cipla India Gel 1% 30gm OTC R Registered by ADK
Company Pvt Ltd
611 P1284 DICLOFENAC DIETHYLAMMONIUM Voltaren Emulgel Novartis Pharma, Germany/ Gel 1% OTC R Registerd by State
Novartis Switzerland Trading Organization
Plc.
612 P2225 DICLOFENAC POTASSIUM Neodol - K Micro Labs ltd Tablet 50 mg OTC R Registered by ADK
Company Pvt Ltd
613 P1213 DICLOFENAC POTASSIUM Cataflam Novartis Kurtkoy, Tablet 50 mg OTC R 12.02.2014 Registerd by State
Turkey/Novartis Pharma Trading Organization
AG,Switzerland Plc.

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 35 of 113 Authorized by:DG,MFDA
 614 P3576 DICLOFENAC POTASSIUM BP Deflam CCL Pharmaceuticals, Tablet 50 mg POM Re E 06.10.2015- Market Exclusivity
Pakistan 05.10.2020 given to State Trading
Organization Plc.

615 P2508 DICLOFENAC SODIUM Biclopan 50 Pharmachemie BV, The Tablet 50 mg OTC R 25.01.2011 Registered by ADK
Netherland Company Pvt Ltd
616 P2505 DICLOFENAC SODIUM Clofenac 50 Square Pharmaceuticals, Suppository 50 mg POM R 04.07.2011 Registered by Dial
Bangladesh Trade and Travels Pte.
Ltd.
617 P3160 DICLOFENAC SODIUM Hovid Clofenac 75 Hovid Bhd, Malaysia Injection 75 mg/3ml POM R 19.08.2014 Registered by GKT
Pharmacy
618 P1652 DICLOFENAC SODIUM Dicloran Unique, India Injection 75mg/3ml POM R E Registered by ADK
Company Pvt Ltd
619 P256 DICLOFENAC SODIUM Reactin SR Cipla India Tablet 100mg OTC R E 17.12.2009 Registered by ADK
Company Pvt Ltd
620 P2307 DICLOFENAC SODIUM Voltaren Ophtha Excelvision Ag Switzerland/ Eye Drops 1% POM R 02.02.2010 Registerd by State
Oftalmico Novartis Pharma Ag Trading Organization
Switzerland Plc.
621 P1285 DICLOFENAC SODIUM Voltaren Delpharm Huningue SAS, Tablet 25 mg OTC R E Registerd by State
France Trading Organization
Plc.
622 P1286 DICLOFENAC SODIUM Voltaren 50 Novartis Urunleri, Istanbul Enteric coated 50 mg OTC R E Registerd by State
Turkey tablet Trading Organization
Plc.
623 P1881 DICLOFENAC SODIUM Voltaren SR 75 Novartis Farma Tablet 75 mg OTC R E Registerd by State
SpA,Italy/Novartis Pharma Trading Organization
A.G Switzerland Plc.
624 P1290 DICLOFENAC SODIUM Voltaren Delpharm Huningue Suppository 12.5 mg POM R E Registerd by State
SAS,France Trading Organization
Plc.
625 P1287 DICLOFENAC SODIUM Voltaren Novartis Pharma SAS,France / Suppository 25 mg OTC R E Registerd by State
Novartis Pharma AG Trading Organization
Switzerland Plc.
626 P1288 DICLOFENAC SODIUM Voltaren Novartis Pharma SAS,France / Suppository 50 mg OTC R E Registerd by State
Novartis Pharma AG Trading Organization
Switzerland Plc.
627 P2604 DICLOFENAC SODIUM Clofenac 50 Hovid Bhd, Malaysia Tablet 50 mg OTC R 10.07.2012 Registered by GKT
Pharmacy
628 P1960 DICLOFENAC SODIUM Clofenac Square Pharmaceuticals, Injection 75 mg POM R E
Bangladesh
629 P2136 DICLOFENAC SODIUM Inflavan 50 Khandelwal Laboratories Pvt Tablet 50 mg OTC R
Ltd
630 P2137 DICLOFENAC SODIUM Inflavan 25 Khandelwal Laboratories Pvt Tablet 25 mg OTC R
Ltd
631 P1968 DICLOFENAC SODIUM Clofenac SR Square Formulations Tablet 100 mg OTC R E
Ltd. Tangail, Bangladesh
632 P1972 DICLOFENAC SODIUM Clofenac DT Square Pharmaceuticals, Tablet 50 mg OTC R E
Bangladesh
633 P1291 DICLOFENAC SODIUM Voltaren SR Novartis Pharma AG, Tablet 100 mg OTC R E
Switzerland

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 36 of 113 Authorized by:DG,MFDA
 634 P2864 DICLOFENAC SODIUM Voren 50 Suppo Y.S.P Inductries , Malaysia Suppository 50 mg POM R 07.11.2013 Registered by Dial
Trade and Travels Pte.
Ltd.
635 P2865 DICLOFENAC SODIUM Voren 25 Suppo Y.S.P Inductries , Malaysia Suppository 25 mg POM R 07.11.2013 Registered by Dial
Trade and Travels Pte.
Ltd.
636 P1977 DICLOFENAC SODIUM Profenac 25 Cipla India Suppository 25 mg POM R E 23.05.2005
637 P1978 DICLOFENAC SODIUM Profenac 50 Cipla India Suppository 50 mg POM R E 23.05.2005
638 P1979 DICLOFENAC SODIUM Profenac 100 Cipla India Suppository 100 mg POM R E 23.05.2005
639 P1961 DICLOFENAC SODIUM Clofenac 12.5 Square Pharmaceuticals, Suppository 12.5 mg POM R
Suppository Bangladesh
640 P3490 DICLOFENAC SODIUM Diclomol Win-Medicare Pvt Ltd, India Injection 25mg/ 1 ml (3ml) POM Re 19.05.2015- Market Exclusivity
18.05.2020 given to AMDC Pvt.
Ltd.
641 P3491 DICLOFENAC SODIUM Soludol Win-Medicare Pvt Ltd, India Disperible Tablet 46.5mg (equivallent 50 mg) POM Re 19.05.2015- Market Exclusivity
18.05.2020 given to AMDC Pvt.
Ltd.
642 P4341 DICLOFENAC SODIUM Zolterol SR Upha Pharmaceutical Sustained release 100mg POM Re E 02.10.2018 - Market Exclusivity
Manufacturing (M) Sdn. Bhd. tablet 01.10.2023 given to Dial Trade
Lot 2& 4, Jalan p/7, Section and Travels Pte. Ltd.
13, Bangi Industrial Estate,
43650, Bandar Baru Bangi,
Selangor Darul Ehsan,
Malaysia

643 P4342 DICLOFENAC SODIUM Zolterol SR Upha Pharmaceutical Sustained release 75mg POM Re E 02.10.2018 - Market Exclusivity
Manufacturing (M) Sdn. Bhd. tablet 01.10.2023 given to Dial Trade
Lot 2& 4, Jalan p/7, Section and Travels Pte. Ltd.
13, Bangi Industrial Estate,
43650, Bandar Baru Bangi,
Selangor Darul Ehsan,
Malaysia

644 P4327 DICLOFENAC SODIUM (Contains Benzoyl Zobid SM Pharmaceuticals Sdn. Bhd. Injection 25mg/ml (3ml ampoule) POM Re E 02.10.2018 - Market Exclusivity
alcohol 4% 0.12ml) Lot 88, Sungai Petani 01.10.2023 given to Green
Industrial Estate, 08000 Pharmacy Godown
Sungai Petani, Kedah,
Malaysia
645 P2049 DICLOFENAC SODIUM BP Diclo 50 Medopharm, India Tablet 50 mg OTC R Registered by Green
Pharmacy
646 P2210 DICLOFENAC SODIUM BP Diclo 100 Medopharm, India Tablet 100 mg OTC R E Registered by Green
Pharmacy
647 P151 DICLOFENAC SODIUM BP Diclotal DT Blue Cross Laboratories India Tablet 50 mg OTC R E Registered by ADK
Company Pvt Ltd
648 P2126 DICLOFENAC SODIUM BP Decifen SR Medley Ltd, India. Tablet 100 mg OTC R
649 P3945 DICYCLOMINE HYDROCHLORIDE + Axcel Dicyclomine- Kotra Pharma (M) Sdn. Bhd., Syrup 5mg+50mg per 5ml (100ml POM Re 01.11.2016 - Market Exclusivity
SIMETHICONE S 1, 2, & 3 Jalan TTC 12, Cheng bottle) 31.10.2021 given to State Trading
Industrial Estate, 75250 Organization Plc.
Melaka, Malaysia

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 37 of 113 Authorized by:DG,MFDA
 650 P1519 DIFLUCORTLONE VALERATE Nerisone Schering AG, Germany Cream 0.10% POM R
651 P1520 DIFLUCORTLONE VALERATE Nerisone Schering AG, Germany Ointment 0.10% POM R
652 P1521 DIFLUCORTLONE VALERATE Nerisone C Schering AG, Germany Cream 0.10% POM R
+CHLORGUINADOL
653 P1585 DILTIAZEM Herbesser SR Tanabe Seiyaku, Japan Tablet 100mg POM R
654 P1586 DILTIAZEM Herbesser SR Tanabe Seiyaku, Japan Tablet 200mg POM R
655 P325 DILTIAZEM Dilzem Douglas New Zealand Tablet 30 mg POM R
656 P326 DILTIAZEM Dilzem Douglas New Zealand Tablet 60 mg POM R
657 P3994 DILTIAZEM HYDROCHLORIDE Dilcontin XL 120 Modi-Mundipharma Private Controlled Release 120mg POM Re 01.08.2017 - Market Exclusivity
Limited, Modipuram - 250 Tablet 01.08.2022 given to AMDC Pvt.
110, Uttar Pradesh, India Ltd.

658 P3995 DILUTED NITROGLYCERIN USP Nitrocontin 6.4 Modi-Mundipharma Private Controlled Release 6.4mg POM Re 01.08.2017 - Market Exclusivity
Limited, Modipuram - 250 Tablet 01.08.2022 given to AMDC Pvt.
110, Uttar Pradesh, India Ltd.

659 P3996 DILUTED NITROGLYCERIN USP Nitrocontin 2.6 Modi-Mundipharma Private Controlled Release 2.6mg POM Re 01.08.2017 - Market Exclusivity
Limited, Modipuram - 250 Tablet 01.08.2022 given to AMDC Pvt.
110, Uttar Pradesh, India Ltd.

660 P3534 DIPHENHYDRAMINE HCL + AMMONIUM Hova Expectorant Hovid Bhd. 121, Jalan Tunku Oral Liquid 14 mg+ 135mg + 57 mg / 5 ml POM Re 19.05.2015- Market Exclusivity
CHLORIDE +SODIUM CITRATE Abdul Rahman, 30010 Ipoh, 18.05.2020 given to My Chemist
Malaysia Wholesale
661 P2405 DIPHENHYDRAMINE HCL + AMMONIUM Emcof Medopharm, India Oral Liquid 12.5mg+100mg +2mg in 5ml POM R 30.09.2010 Registered by Green
CHLORIDE BP + LEVOMENTHOL BP Pharmacy

662 P1793 DIPHENHYDRAMINE HCL BP + Zeet Expectorant Alembic Pharmaceuticals Oral Liquid 8mg + 4mg + 50mg + 100mg + POM R
BROMOHEXINE HCL BP + GUAIPHENESIN BP Limited India 1mg in 5ml
+ AMMONIUM CHLORIDE BP +
LEVOMENTHOL BP
663 P3463 DIPTHERIA TOXOID + PERTUSIS TOXOID + Boostrix Glaxo Smithkline Biologicals, Vaccine Each 0.5 ml (single dose) POM Re 24.03.2015 - Market Exclusivity
TETANUS TOXOID Belgium Diptheria toxoid 2.5 Lf 23.03.2020 given to ADK Company
(not less tha 2IU) + Tetanus Pvt. Ltd.
Toxoid 5.0 LF
(not less than 20 IU) + Pertusis
Toxoid 8µg

664 P805 DM + TRIPROLIDINE HCL + PHENYLEPHRINE Ascoril D Glenmark , India Oral Liquid 10mg + 1.25mg + 5 mg in 5 ml POM R E 16.08.2010 Registered by ADK
Company Pvt Ltd
665 P2260 DM BP + TRIPROLIDINE HCL + Ascodex Glenmark , India Oral Liquid 10 mg + 1.25 mg + 30 mg in NATIONALLY R Registered by ADK
PSEUDOEPHEDRINE BP 5ml CONTROLLED Company Pvt Ltd
(PSYCHOTROPIC)
666 P1060 DOBUTAMINE Dobutrex Neon Laboratories, India Injection 250mg/20ml POM R E
667 P1835 DOCUSATE SODIUM (CERUMOLYTIC) Soluwax HOE Pharmaceutical Ear Drops 0.50% OTC R E
Manufacturing (M) Sdn. Bhd.,
Malaysia
668 P2406 DOMPERIDONE Dolium 10 Medopharm, India Tablet 10 mg POM R 30.09.2010 Registered by Green
Pharmacy
669 P1868 DOMPERIDONE Motinorm Drops Medley Ltd, India. Oral Drops 10mg/ml in 5ml POM R Registered by ADK
Company Pvt Ltd

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 38 of 113 Authorized by:DG,MFDA
 670 P2577 DOMPERIDONE Vometa Dexa Medica, Indonesia Oral Liquid 5 mg/5 ml POM R 03.04.2012 Registered by ADK
Company Pvt Ltd
671 P3569 DOMPERIDONE Motilium M J&J, India Tablet 10 mg POM Re 08.09.2015 - Market Exclusivity
07.09.2020 given to Mediquip
Maldives Pvt. Ltd.
672 P3738 DOMPERIDONE Motidone Duopharma (M) Tablet 10mg POM Re 24.05.2016 - Market Exclusivity
Sdn.Bhd,Malaysia 23.05.2021 given to Dial Trade
and Travels Pte. Ltd.
673 P3963 DOMPERIDONE Omidon Incepta Pharmaceuticals Ltd, Suspension 5mg/5ml POM Re 14.03.2017 - Market Exclusivity
Dewan Idris Road, Bara 14.03.2022 given to Dial Trade
Rangamatia, Ziranbo, Savar, and Travels Pte. Ltd.
Dhaka, Bangladesh

674 P259 DOMPERIDONE Vomistop Cipla India Tablet 10 mg POM R 23.11.2009 Registered by ADK
Company Pvt Ltd
675 P2718 DOMPERIDONE BP Domstal Torrent Pharmaceuticals, Tablet 10 mg POM R 19.02.2013 Registered by Life
India Support Pvt Ltd
676 P2479 DOMPERIDONE BP Dompi Suspension MMC Health Care Ltd,India Oral Liquid 1 mg/ml POM R Registered by Green
Pharmacy
677 P3210 DOMPERIDONE BP Smood Hovid Bhd, Malaysia Tablet 10 mg POM R 06.11.2014 Registered by GKT
Pharmacy
678 P2386 DOMPERIDONE BP Emelium 10 Micro Labs ltd Tablet 10 mg POM R E 16.08.2010 Registered by ADK
Company Pvt Ltd
679 P3468 DOMPERIDONE BP Emidone Pharmix Laboratories Pakistan Suspension 1mg/1ml POM Re 21.04.2015 - Market Exclusivity
20.04.2020 given to Life Support
Pvt. Ltd.
680 P3483 DOMPERIDONE BP Emidone Pharmix Laboratories Pakistan Tablet 10 mg POM Re 21.04.2015 - Market Exclusivity
20.04.2020 given to Life Support
Pvt. Ltd.
681 P3202 DOMPERIDONE BP Motigut Square Pharmaceuticals, Oral Liquid 5 mg in 5ml POM R 06.11.2014 Registered by Dial
Bangladesh Trade and Travels Pte.
Ltd.
682 P1138 DOMPERIDONE BP Motinorm Medley Ltd, India. Tablet 10 mg POM R Registered by ADK
Company Pvt Ltd
683 P1879 DOMPERIDONE BP Motinorm Oral Medley Ltd, India. Oral Liquid 5mg/5ml POM R
liquid
684 P3117 DOMPERIDONE BP + PANTOPRAZOLE USP Dompan OD Medley Ltd, India. Tablet 30 mg(in SR form) + 40 mg POM R 08.07.2014 Registered by ADK
Company Pvt Ltd
685 P971 DOSULEPIN( Dothiepin) Prothiaden Acme Generics LLP, Plot No. Tablet 25 mg POM R 07.01.14 Registered by Life
115, HPSIDC, Indusrial Area Support Pvt Ltd
Davni, P.O. Gurumajra, Tehsil
Nalagarh, Distt. Solan (H.P)
INDIA

686 P972 DOSULEPIN( Dothiepin) Prothiaden Acme Generics LLP, Plot No. Tablet 75mg POM R 07.01.14 Registered by Life
115, HPSIDC, Indusrial Area Support Pvt Ltd
Davni, P.O. Gurumajra, Tehsil
Nalagarh, Distt. Solan (H.P)
INDIA

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 39 of 113 Authorized by:DG,MFDA
 687 P1991 DOXYCYCLINE Doxicon Medopharm, India Capsule 100 mg POM R E Registered by Green
Pharmacy
688 P2785 DOXYCYCLINE Doxycap Hovid Bhd, Malaysia Capsule 100 mg POM R 05.06.2013 Registered by GKT
Pharmacy
689 P1671 DOXYCYCLINE Doxi – 1 USV, India Capsule 100 mg POM R E
690 P2016 DOXYCYCLINE Doxigen General Pharmacueticals Capsule 100 mg POM R E
Ltd,Bangladesh
691 P3589 DOXYCYCLINE HYDROCHLORIDE Doxycycline Pharmaniaga Manufacturing Capsule 100 mg POM Re 20.10.2015- Market Exclusivity
Berhad, 11A, Jalan P/1, 19.10.2020 given to Dial Trade
Kawasan Perusahaan Bangi, and Travels Pte. Ltd.
43650 Bandar Baru Bangi,
Selangor Darul Ehsan,
Malaysia

692 P2416 DOXYCYCLINE IP Lenteclin Aristo India Capsule 100mg POM R 07.10.2010 Registered by ADK
Company Pvt Ltd
693 P2373 DPT + HEP B Tritanrix Hep B GlaxoSmithKline, Belgium Vaccine POM R
Vaccine
694 P968 DREIED ALUMINIUM HYDROXIDE GEL I.P + Digene Abbott India Limited Tablet 300mg+50mg+25mg+25mg OTC R E 18.05.2014 Registered by Life
MAGNESIUM ALUMINIUM SILICATE Support Pvt Ltd
HYDRATE + MAGNESIUM HYDROXIDE I.P +
SIMETHICONE I.P
695 P3997 DRIED ALUMINIUM HYDROXIDE GEL I.P. + Digene (Mint Abbott India Limited L-18 Chewable tablet 300mg + 50mg + 25mg + 25mg OTC Re E 01.08.2017 - Market Exclusivity
MAGNESIUM ALUMINIUM SILICATE Flavour) Verna Industrial Area, Verna, 01.08.2022 given to ADK
HYDRATE + MAGNESIUM HYDROXIDE I.P. + Salcette, Goa-403 722, INDIA Pharmaceutical
SIMETHICONE I.P. Company Pvt. Ltd.
696 P3481 DULOXETINE Durole Pharmix Laboratories Pakistan Capsule 60 mg POM Re 21.04.2015 - Market Exclusivity
20.04.2020 given to Life Support
Pvt. Ltd.
697 P3952 DUTASTERIDE Avodart GlaxoSmithKline Soft Capsule 0.5 mg POM Re 06.12.2016- Market Exclusivity
Pharmaceuticals S.A., Poznan, 05.12.2021 given to State Trading
Poland Organization Plc.

698 P3482 DYDROGESTERONE Hirone Pharmix Laboratories Pakistan Tablet 10 mg POM Re 21.04.2015 - Market Exclusivity
20.04.2020 given to Life Support
Pvt. Ltd.
699 P438 DYDROGESTERONE IP Duphaston Abbott, India Tablet 10 mg POM R 3.2018

700 P4136 EACH TABLET CONTAINS VITAMIN D , Pregnacare Vitabiotics, England Tablet 10 mcg + 70 mg + 3mg + OTC R 18.06.13 Registered by Life
VITAMIN C, THIAMIN, VITAMIN B6, Vitamin B 6 9 mg + 5 mg + 20 Support Pvt Ltd
RIBOFLAVIN ,NIACIN ,VITAMIN B6, FOLIC mg + 20 mg + 400mcg + 126
ACID,VITAMIN B ,BIOTIN , PANTOTHENIC mcg + 150mcg, 6 mg + 150 mg,
ACID ,MAGNESIUM , IRON,,ZINC , COPPER + 17 mg + 15 mg + 1000 mcg +
SELENIUM,IODINE 30mcg + Iodine 140 mcg

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 40 of 113 Authorized by:DG,MFDA
 701 P4137 EACH TABLET CONTAINS VITAMIN D, Neurozan Vitabiotics, England Capsule 20μg + 36 mg + 25 mg + 3 mg + OTC R 18.06.13 Registered by Life
VITAMIN E, THIAMINE, RIBOFLAVIN , 8 mg + 100μg + 400μg + 32 mg Support Pvt Ltd
VITAMIN B6, VITAMIN B ,FOLACIN,NIACI, + 12 mg+ 8 mg + 15 mg + 75
PANTOTHENICACID,IRON mg + 1 mg + 110μg + 150μg +
,ZINC,MAGNESIUM,COPPER, 40 mg
SELENIUM,,IODINE,L- ARGININE

702 P858 ECONAZOLE + TRIAMICINOLONE Ecocort HOE Pharmaceutical Cream 1% w/w + 0.1% w/w 15g POM R Registered by Dial
ACETONIDE Manufacturing (M) Sdn. Bhd., Trade and Travels Pte.
Malaysia Ltd.
703 P859 ECONAZOLE NITRATE Ecoderm Cream HOE Pharmaceutical Cream 1%w/w in 15g POM R Registered by Dial
Manufacturing (M) Sdn. Bhd., Trade and Travels Pte.
Malaysia Ltd.
704 P4381 ECONAZOLE NITRATE + TRIAMCINOLONE Fungi-Stat SM Pharmaceuticals SDN BHD Cream 1% w/w + 0.1% w/w (15g) POM Re 23.10.2018 - Market Exclusivity
ACETONIDE (218620-M) Lot 88, Sungai 22.10.2023 given to Green
Petani, Industrial Estate, Pharmacy Godown
08000 Sungai, Petani, Kedah, Only
Malaysia
705 P3937 EICOSAPENTAENOIC ACID + Maxepa MERCK LIMITED, Plot No. Soft Gelatin 180 mg + 120 mg POM Re 01.11.2016 - Market Exclusivity
DOCOSAHEXAENOIC ACID 11/1, Marwasodo, Usgaon, Capsule 31.10.2021 given to State Trading
Ponda, Goa - 403 407, India Organization Plc.

706 P3484 ELEMENT IRON + FOLIC ACID BP Polyrole Pharmix Laboratories Pakistan Tablet 100 mg + 0.35 mg POM Re 21.04.2015 - Market Exclusivity
20.04.2020 given to Life Support
Pvt. Ltd.
707 P799 Elemental Iron+ Folic Acid Mumfer Chewable Glenmark , India Tablet 100 mg+500 mcg OTC R E Registered by ADK
Tablet Company Pvt Ltd

708 P1794 ENALAPRIL Minipril Alembic Pharmaceuticals Tablet 5 mg POM R E

Limited India
709 P2119 ENALAPRIL Emlapril Medopharm, India Tablet 5 mg POM R Registered by Green
Pharmacy
710 P261 ENALAPRIL Dilvas Cipla India Tablet 5 mg POM R E 17.12.2009 Registered by ADK
Company Pvt Ltd
711 P1967 ENALAPRIL Vasopril 5 Square Pharmaceuticals, Tablet 5 mg POM R E
Bangladesh
712 P1139 ENALAPRIL USP Encardil-5 Medley Ltd, India. Tablet 5 mg POM R E Registered By ADK
Company Pvt Ltd
713 P3755 ENOXAPARIN Clexane Sanofi Winthrop Industries , Injection 6000 anti-Xa IU/0.6ml POM Re 06.09.2016 - Market Exclusivity
France 05.09.2021 given to State Trading
Organization Plc.

714 P3574 EPOETIN ALFA (RECOMBINANT HUMAN Hemapo Shandong Kexing Bioproducts Injection 2000 IU/ ml POM Re 06.10.2015- Market Exclusivity
ERYTHROPOIETIN) Co.Ltd, Tangwangshan Road, 05.10.2020 given to State Trading
Mingshui Development Zone Organization Plc.
Zhangqiu, Shandong - China

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 41 of 113 Authorized by:DG,MFDA
 715 P3999 EPOETIN ALFA (RECOMBINANT HUMAN Hemapo Epoetin Shandong Kexing Bioproducts Injection (pre- 3000IU/ml POM Re 15.08.2017 - Market Exclusivity
ERYTHROPOIETIN) alfa Co.Ltd, Shandong- China filled syringe) 14.08.2022 given to State Trading
(Address: No.2666,Chuangye Organization Plc.
Road, mingshui Development
Zone, Zhangqiu, Shandong,
China)

716 P1479 EPOETIN BETA Recormon Roche, Switzerland Injection 1000 IU POM R
717 P1480 EPOETIN BETA Recormon Roche, Switzerland Injection 2000 IU POM R
718 P1481 EPOETIN BETA Recormon Roche, Switzerland Injection 5000 IU POM R
719 P32 ERYTHROMYCIN Althrocin S Alembic Pharmaceuticals Tablet 250mg POM R E Registered by Dial
Limited India Trade and Travels Pte.
Ltd.
720 P33 ERYTHROMYCIN Althrocin S Alembic Pharmaceuticals Tablet 500mg POM R E Registered by Dial
Limited India Trade and Travels Pte.
Ltd.
721 P31 ERYTHROMYCIN Althrocin E Alembic Pharmaceuticals Oral Liquid 125mg POM R E Registered by Dial
Limited India Trade and Travels Pte.
Ltd.
722 P2445 ERYTHROMYCIN Nivamycin Medopharm, India Tablet 500 mg POM R E 22.10.2010 Registered by Green
Pharmacy
723 P2446 ERYTHROMYCIN Nivamycin Medopharm, India Tablet 250 mg POM R E 22.10.2010 Registered by Green
Pharmacy
724 P2786 ERYTHROMYCIN Erogran Hovid Bhd, Malaysia Granules (Dry 200 mg/5 ml POM R E 05.06.2013 Registered by GKT
Oral liquid) Pharmacy

725 P2802 ERYTHROMYCIN Firmac Incepta pharmaceuticals Tablet 250 mg POM R 26.08.2013 Registered by Dial
Limited, Bangladesh Trade and Travels Pte.
Ltd.
726 P2019 ERYTHROMYCIN Eromac General Pharmacueticals Oral Liquid 125 mg/5 ml POM R E
Ltd,Bangladesh
727 P3585 ERYTHROMYCIN Pharmaniaga Idaman Pharma Oral Liquid 200 mg/5 ml POM Re 14.03.2017 - Market Exclusivity
Erythromycin Manufacturing Sdn Bhd Lot 13.03.2022 given to Dial Trade
No. 24, Bakar Arang Industrial and Travels Pte. Ltd.
Estate 08000 Sungai Petani,
Kedah, Malaysia

728 P3956 ERYTHROMYCIN Axcel Erythomycin Kotra Pharma (M) Sdn. Bhd., Dry Powder 200mg / 5ml POM Re 06.12.2016- Market Exclusivity
ES-200 1, 2, & 3 Jalan TTC 12, Cheng 05.12.2021 given to State Trading
Industrial Estate, 75250 Organization Plc.
Melaka, Malaysia

729 P4355 ERYTHROMYCIN ETHYLSUCCINATE Erysol Xepa-Soul Pattinson Powder for Oral 200mg/5ml (60ml) POM Re E 16.10.2018 - Market Exclusivity
(Malaysia) SDN. BHD. 1-5 Suspension 15.10.2023 given to ADK
Cheng Industrial Estate, 75250 Pharmaceutical
Melaka, Malaysia Company Pvt. Ltd.
730 P1905 ERYTHROMYCIN STEARATE IP Erostat Sterling Lab, India Tablet 250mg POM R Registered by AMDC
Pvt Ltd

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 42 of 113 Authorized by:DG,MFDA
 731 P2481 ERYTHROMYCIN USP Leothrocin MMC Health Care Ltd,India Tablet 500 mg POM R 23.02.2011 Registered by Green
Pharmacy
732 P2633 ERYTHROPOEITIN BP Relipoietin Reliance Life Sciences Pvt Injection 4000 IU POM R 18.09.2012 Registerd by State
Ltd,India Trading Organization
Plc.
733 P2634 ERYTHROPOEITIN BP Relipoietin Reliance Life Sciences Pvt Injection 2000 IU POM R 18.09.2012 Registerd by State
Ltd,India Trading Organization
Plc.
734 P2542 ERYTHROPOEITIN IP Wepox Wockhardt, India Injection 2000IU/0.5ml POM R 17.01.2012 Registered by Life
(Prefilled) Support Pvt Ltd
735 P2543 ERYTHROPOEITIN IP Wepox Wockhardt, India Injection 4000IU/0.5ml POM R 17.01.2012 Registered by Life
(Prefilled) Support Pvt Ltd
736 P2545 ESCITALOPRAM Feliz-S Torrent Pharmaceuticals, Tablet 10 mg POM R
India
737 P3477 ESCITALOPRAM Anidep Pharmix Laboratories Pakistan Tablet 10 mg POM Re 21.04.2015 - Market Exclusivity
20.04.2020 given to Life Support
Pvt. Ltd.
738 P2876 ESOMEPRAZOLE Esoz Glenmark , India Injection 40 mg POM R E 07.01.2014 Registered by ADK
Company Pvt Ltd
739 P2256 ESOMEPRAZOLE Esonix 20 Incepta pharmaceuticals Tablet 20 mg POM R Registered by Dial
Limited, Bangladesh Trade and Travels Pte.
Ltd.
740 P2321 ESOMEPRAZOLE Esopel Medopharm, India Tablet 20 mg POM R 28.02.2010 Registered by Green
Pharmacy
741 P2322 ESOMEPRAZOLE Esopel Medopharm, India Tablet 40 mg POM R 28.02.2010 Registered by Green
Pharmacy
742 P2243 ESOMEPRAZOLE Esofag 40 Micro Labs ltd Tablet 40 mg POM R Registered by ADK
Company Pvt Ltd
743 P3462 ESOMEPRAZOLE Esonix Incepta pharmaceuticals Tablet 40 mg POM Re 24.03.2015 - Market Exclusivity
Limited, Bangladesh 23.03.2020 given to Dial Trade
and Travels Pte. Ltd.
744 P1934 ESOMEPRAZOLE Esoz 20 Glenmark , India Tablet 20 mg POM R E
745 P2237 ESOMEPRAZOLE Esofag 20 Micro Labs ltd Tablet 20mg POM R E Registered by ADK
Company Pvt Ltd
746 P3472 ESOMEPRAZOLE Trutil Pharmix Laboratories Pakistan Capsule 20 mg POM Re E 21.04.2015 - Market Exclusivity
20.04.2020 given to Life Support
Pvt. Ltd.
747 P3474 ESOMEPRAZOLE Trutil Pharmix Laboratories Pakistan Capsule 40 mg POM Re E 21.04.2015 - Market Exclusivity
20.04.2020 given to Life Support
Pvt. Ltd.
748 P3658 ESOMEPRAZOLE Espra CCL Pharmaceuticals, Capsule 20 mg POM Re 21.01.2016 - Market Exclusivity
Pakistan 20.01.2021 given to State Trading
Organization Plc.

749 P3659 ESOMEPRAZOLE Espra CCL Pharmaceuticals, Capsule 40 mg POM Re 21.01.2016 - Market Exclusivity
Pakistan 20.01.2021 given to State Trading
Organization Plc.

750 P1933 ESOMEPRAZOLE BP Esoz 40 Glenmark , India Tablet 40 mg POM R E

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 43 of 113 Authorized by:DG,MFDA
 751 P2708 ESOMEPRAZOLE IP Nexpro Torrent Pharmaceuticals, Tablet 40 mg POM R 19.02.2013 Registered by Life
India Support Pvt Ltd
752 P2707 ESOMEPRAZOLE IP Nexpro Torrent Pharmaceuticals, Tablet 20 mg POM R E 19.02.2013 Registered by Life
India Support Pvt Ltd
753 P3624 ESOMEPRAZOLE MAGNESIUM TRIHYDRATE Fasteso PharmEvo (Private) Limited, Enteric coated 40 mg POM Re E 17.11.2015- Market Exclusivity
Plot # A-29, North Western tablet 16.11.2020 given to Life Support
Industrial Zone, Port Qasim, Pvt. Ltd.
Karachi-75020, Pakistan

754 P3627 ESOMEPRAZOLE MAGNESIUM TRIHYDRATE Fasteso PharmEvo (Private) Limited, Enteric coated 20 mg POM Re E 17.11.2015- Market Exclusivity
Plot # A-29, North Western tablet 16.11.2020 given to Life Support
Industrial Zone, Port Qasim, Pvt. Ltd.
Karachi-75020, Pakistan

755 P3679 ESOMEPRAZOLE MAGNESIUM TRIHYDRATE Esoswift 40 Swiss Garnier Life Sciences, Tablet 40 mg POM Re 01.03.2016- Market Exclusivity
USP No. 21-23, Industrial Area, 28.02.2021 given to AMDC Pvt.
Mehatpur, Dist: UNA, (H.P.)- Ltd.
174 315, India

756 P3680 ESOMEPRAZOLE MAGNESIUM TRIHYDRATE Esoswift 20 Swiss Garnier Life Sciences, Tablet 20 mg POM Re 01.03.2016- Market Exclusivity
USP No. 21-23, Industrial Area, 28.02.2021 given to AMDC Pvt.
Mehatpur, Dist: UNA, (H.P.)- Ltd.
174 315, India

757 P3504 ESOMEPRAZOLE SODIUM Emep IV Aristo Pharma Limited, Injection 40 mg POM Re E 19.05.2015- Market Exclusivity
Bangladesh 18.05.2020 given to Life Support
Pvt. Ltd.
758 P3150 ESOMEPRAZOLE USP EPZ - 20 Atoz Pharmaceuticals ,India Tablet 20 mg POM R 19.08.2014 Registered by My
Chemist Wholesale

759 P3151 ESOMEPRAZOLE USP EPZ - 40 Atoz Pharmaceuticals ,India Tablet 40 mg POM R 19.08.2014 Registered by My
Chemist Wholesale

760 P1823 ETHAMSYLATE Ethasyl Tablet FDC India Tablet 250mg POM R
761 P1824 ETHAMSYLATE Ethasyl Tablet FDC India Tablet 500mg POM R
762 P2502 ETONOGESTREL Implanon N.V.Organon Implant 68 mg Restricted for R 21.04.2011 Registered by ADK
Hospital use only Company Pvt Ltd

763 P3735 ETONOGESTREL Implanon NXT N.V.Organon,Oss, Implant 68mg Restricted for R 24.05.2016 Registered
Netherlands Hospital use only

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 44 of 113 Authorized by:DG,MFDA
 764 P4468 ETORICOXIB Etohope 120 Glenmark Pharmaceuticals Film coated tablet 120mg POM Re 09.04.2019 - Market Exclusivity
Ltd. B/2, Mahalaxmi 08.04.2024 given to ADK
Chambers, 22, Bhulabhai Pharmaceuticals
Desai Road, Mumbai- 400 026 Company Pvt. Ltd.
(INDIA)
At: Plot No. 2, Phase - II,
Pharma Zone, SEZ, Pithampur,
Dist. Dhar - 454775, Madhya
Pradesh

765 P4315 ETORICOXIB Etohope 90 Glenmark Pharmaceuticals Film coated Tablet 90mg POM Re 09.04.2019 - Market Exclusivity
Ltd. B/2, Mahalaxmi 08.04.2024 given to ADK
Chambers, 22, Bhulabhai Pharmaceuticals
Desai Road, Mumbai- 400 026 Company Pvt. Ltd.
(INDIA)
At: Plot No. 2, Phase - II,
Pharma Zone, SEZ, Pithampur,
Dist. Dhar - 454775, Madhya
Pradesh

766 P4300 ETORICOXIB Etohope 60 Glenmark Pharmaceuticals Film coated Tablet 60mg POM Re 09.04.2019 - Market Exclusivity
Ltd. B/2, Mahalaxmi 08.04.2024 given to ADK
Chambers, 22, Bhulabhai Pharmaceuticals
Desai Road, Mumbai- 400 026 Company Pvt. Ltd.
(INDIA)
At: Plot No. 2, Phase - II,
Pharma Zone, SEZ, Pithampur,
Dist. Dhar - 454775, Madhya
Pradesh

767 P2330 EVAROLIMUS Certican Novartis Pharma AG, Tablet 0.25 mg POM R 12.02.2010 Registerd by State
Switzerland Trading Organization
Plc.
768 P4339 EVENING PRIMROSE OIL Naturalle Evening Upha Pharmaceutical Soft GelCapsule 1000mg OTC Re 02.10.2018 - Market Exclusivity
Primrose Manufacturing (M) Sdn. Bhd. 01.10.2023 given to Dial Trade
Lot 2& 4, Jalan p/7, Section and Travels Pte. Ltd.
13, Bangi Industrial Estate,
43650, Bandar Baru Bangi,
Selangor Darul Ehsan,
Malaysia

769 P1499 EVENING PRIMROSE OIL Vita EPA plus RP Scherer Holdings Pty Ltd Capsule OTC R

770 P4117 EVENING PRIMROSE OIL Evening Primrose RP Scherer Holdings Pty Ltd Capsule 1000 mg OTC R
oil
771 P4118 EVENING PRIMROSE OIL Evening Primrose RP Scherer Holdings Pty Ltd Capsule 600 mg OTC R
oil

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 45 of 113 Authorized by:DG,MFDA
 772 P3998 EZETIMIBE Ezemibe CCL Pharmaceuticals (Pvt) Ltd, Tablet 10mg POM Re 15.08.2017 - Market Exclusivity
62-Industrial estate, Kot 14.08.2022 given to State Trading
lakhpat, Lahore, Pakistan Organization Plc.

773 P2277 FAMOTIDINE Optifam Merck Marker, Pakistan Tablet 40 mg POM R Registered by ADK
Company Pvt Ltd
774 P2278 FAMOTIDINE Optifam Merck Marker, Pakistan Tablet 20 mg POM R Registered by ADK
Company Pvt Ltd
775 P3613 FEBUXOSTAT Xanurix-40 Micro Labs Limited, 92, Film Coated Tablet 40 mg POM R 25.05.2015 Registered
SIPCOT, HOSUR-635 126 INDIA

776 P3615 FEBUXOSTAT Xanurix-80 Micro Labs Limited, 92, Film Coated Tablet 80mg POM R 25.05.2015 Registered
SIPCOT, HOSUR-635 126 INDIA

777 P2258 FENOFIBRATE Fibral Micro Labs ltd Capsule 200 mg BP POM R Registered by ADK
Company Pvt Ltd
778 P4428 FENOFIBRATE BP Feno-TG Troikaa Pharmaceuticals Film coated tablet 160mg POM Re E 19.03.2019 - Market Exclusivity
Limited, C-1 Sara Industrial 18.03.2024 given to ADK
Estate, Selaqui, Dehradun-248 Pharmaceuticals
197, Uttarakhand, India Company Pvt. Ltd.

779 P2762 FENTANYL Fent Neon Laboratories, India Injection 50mcg/ml in 2 ml INTERNATIONALLY R 08.05.2013 Registerd by State
CONTROLLED Trading Organization
(NARCORTIC) Plc.
780 P1951 FERRIC AMMONIUM CITRATE + FOLIC ACID Dexorange Oral Wardex Pharmacueticals Pvt Oral Liquid 160 mcg (BP)+ 0.5 mg(BP) +7.5 POM R
+ CYNACOBALAMIN +ALCOHOL liquid Ltd, India mcg(BP)+ 96%(USP) in 0.87 ml

781 P2153 FERRIC AMMONIUM CITRATE + FOLIC ACID Fesozinc Liquid Arvind Remedies Ltd, India Oral liquid 100 mg(USP) + 1 mg (BP)+ 5 POM R
+ CYANOCOBALAMIN + PYRIDOXINE mcg (BP)+ 1.5 mg (BP) + 25
HYDROCHLORIDE + ZINC SULPHATE + mg(BP) + 45 mg(BP) in 5 ml
NICOTINAMIDE
782 P2626 FERROUS FUMARATE + CYANOCOBALAMIN Zincofer Apex Laboratories, India Capsule 350 mg+ 5 mcg+ 1 mg+ 75 mg OTC R 18.09.2012 Registered by ADK
+ FOLIC ACID + ASCORBIC ACID + + 1.5mg + 55 mg Company pvt Ltd
PYRIDOXIDE HYDROCHLORIDE + ZINC
SULFATE MONOHYDRATE

783 P2432 Ferrous Fumarate + Folic Acid + vitamin B Ferrovit Mega Life Sciences Capsule 162 mg + 0.75 mg + 7.50 mcg POM R Registered by ADK
Ltd,Thailand Company Pvt Ltd
784 P2417 FERROUS FUMARATE + FOLIC ACID+ Softeron Z Aristo India Capsule 165mg(IP)+750 mcg OTC R 07.10.2010 Registered by ADK
COPPER+ DOCUSATE SODIUM (IP)+1mg+50 mg (IP) Company Pvt Ltd
785 P97 FERROUS FUMARATE + VITAMIN B Dumasules Astron Limited, Sri Lanka Capsule 300mg + Vitamin B complex + OTC R E Registered by ADK
COMPLEX +VITAMIN C Vitamin C Company Pvt Ltd
786 P1679 FERROUS FUMARATE + VITAMIN B12 + Hemsyneral – TD USV, India Capsule 200mg+ 15mcg+1.5mg OTC R E
FOLIC ACID
787 P2487 Ferrous Fumarate+Folic Acid Vefer -HB MMC Health Care Ltd,India Capsule 300 mg (BP)+1 mg (BP)+10 mcg POM R 23.02.2011 Registered by Green
+Cyanocobalamin +Zinc Sulphate +Dioctyl (BP)+ 12.5 mg (USP)+ 50 Pharmacy
Sodium Sulfosuccinate mg(BP)

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 46 of 113 Authorized by:DG,MFDA
 788 P1148 FERROUS GLUCONATE+VITAMIN C+ R.B. Tone Medley Ltd, India. Oral Liquid 200 mg (BP) + 38 mg(BP)+ 12 4 OTC R E Registered By ADK
VITAMIN B 12+THIAMINE NITRATE + mcg(BP )+ 3 mg(BP)+2.5 mg Company Pvt Ltd
RIBOFLAVIN +VITAMIN B 6 +CALCIUM (BP) +1 mg(BP)+ 2.5 mg(BP) +
PANTOTHENATE + NIACINAMIDE + 23 mg(BP) + 150 mg(BP)
CALCIUM LACTATE
789 P1147 FERROUS GLUCONATE+VITAMIN C+ R.B. Tone Medley Ltd, India. Capsule 200 mg (BP) + 38 mg(BP)+ 12 4 OTC R E Registered By ADK
VITAMIN B 12+THIAMINE NITRATE + mcg(BP )+ 3 mg(BP)+2.5 mg Company Pvt Ltd
RIBOFLAVIN +VITAMIN B 6 +CALCIUM (BP) +1 mg(BP)+ 2.5 mg(BP) +
PANTOTHENATE + NIACINAMIDE + 23 mg(BP) + 150 mg(BP)
CALCIUM LACTATE
790 P3260 FEXOFENADINE Allegra Sanofi India Ltd Oral Liquid 30 mg in 5ml POM R 06.01.2015 Registered by ADK
Company Pvt Ltd
791 P2868 FEXOFENADINE Cerafex 120 MMC Health Care Ltd,India Tablet 120 mg POM R 07.01.2014 Registered by Green
Pharmacy
792 P2265 FEXOFENADINE Fexofen 120 Aristo India Tablet 120 mg POM R Registered by ADK
Company Pvt Ltd
793 P2056 FEXOFENADINE Ultigra 180 Medley Ltd, India. Tablet 180mg POM R Registered by ADK
Company Pvt Ltd
794 P2127 FEXOFENADINE Ultigra Suspension Medley Ltd, India. Oral Liquid 60 mg/5ml POM R

795 P2134 FEXOFENADINE Allerfast 180 Khandelwal Laboratories Pvt Tablet 180 mg POM R
Ltd
796 P2651 FEXOFENADINE Allefast Sterling Lab, India. Tablet 120 mg POM R 02.10.2012 Registered by AMDC
Pvt Ltd
797 P2377 FEXOFENADINE Allegra 120 Sanofi India Ltd Tablet 120 mg POM R 25.07.2010 Registered by ADK
Company Pvt Ltd
798 P2378 FEXOFENADINE Allegra 180 Sanofi India Ltd Tablet 180 mg POM R 25.07.2010 Registered by ADK
Company Pvt Ltd
799 P2376 FEXOFENADINE Allegra 30 Sanofi India Ltd Tablet 30 mg POM R 25.07.2010 Registered by ADK
Company Pvt Ltd
800 P3520 FEXOFENADINE HCL USP Alfex -180 Atoz Pharmaceuticals, India Tablet 180 mg POM Re 19.05.2015- Market Exclusivity
18.05.2020 given to My Chemist
Wholesale
801 P3522 FEXOFENADINE HCL USP Alfex - 120 Atoz Pharmaceuticals, India Tablet 120 mg POM Re 19.05.2015- Market Exclusivity
18.05.2020 given to My Chemist
Wholesale
802 P2264 FEXOFENADINE IP Fexofen 180 Aristo India Tablet 180 mg POM R Registered by ADK
Company Pvt Ltd
803 P3154 FEXOFENADINE USP Alrin CCL Pharmaceuticals, Tablet 60 mg POM R E 19.08.2014 Registered by ADK
Pakistan Company Pvt Ltd
804 P2499 FEXOFENADINE USP Fexovin Arvind Remedies Ltd, India Tablet 120 mg POM R 23.02.2011 Registered by Green
Pharmacy
805 P2867 FEXOFENADINE USP Cerafex 180 MMC Health Care Ltd,India Tablet 180 mg POM R 07.01.2014 Registered by Green
Pharmacy
806 P1874 FEXOFENADINE USP Ultigra -120 Medley Ltd, India. Tablet 120mg POM R

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 47 of 113 Authorized by:DG,MFDA
 807 P4140 FLAX SED, GARLIC , VITAMIN E , THIAMIN , Cardioace Vitabiotics Ltd, UK Tablet 100 mg + 200 mg, 40 mg + 10 OTC R 26.08.13 Registered by Life
RIBOFLAVIN , VITAMIN B6, VITAMIN B 12 , mg + 1.4 mg + B6 8 mg + 20 Support Pvt Ltd
FOLIC ACID , VITAMIN D3, SELENIUM, mcg + 100 mcg + 80 mg + 2
VITAMIN C , MANGANESE, CHROMIUM , mg+ 100 mcg + Iron 10 mg +
IRON,IDODINE, NIACIN , MAGNESIUM 150 mcg + 16 mg + 60 mg

808 P823 FLUCINOLONE + NEOMYCIN Supricort N Glenmark , India Cream 0.025%+0.5% POM R 16.10.2010 Registered by ADK
Company Pvt Ltd
809 P3142 FLUCONAZOLE Flucoject -150 Cassel Research Laboratories, Capsule 150 mg(USP ) POM R 19.08.2014 Registered by My
India Chemist Wholesale

810 P2911 FLUCONAZOLE Fungicon 150 Micro Labs ltd Capsule 150 mg POM R E 18.03.2014 Registered by ADK
Company Pvt Ltd
811 P2856 FLUCONAZOLE Difluvid Hovid Bhd, Malaysia Capsule 150 mg POM R 07.11.2013 Registered by GKT
Pharmacy
812 P2181 FLUCONAZOLE Avezole 150 Aegis Ltd Capsule 150 mg POM R E
813 P525 FLUCONAZOLE Zocon FDC India Tablet 150 mg POM R E
814 P2012 FLUCONAZOLE Flugal Square Pharmaceuticals, Capsule 150 mg POM R E
Bangladesh
815 P3494 FLUCONAZOLE Logican Win-Medicare Pvt Ltd, India Capsule 150 mg POM Re 19.05.2015- Market Exclusivity
18.05.2020 given to AMDC Pvt.
Ltd.
816 P3469 FLUCONAZOLE Onlezole Pharmix Laboratories Pakistan Capsule 50 mg USP POM Re 21.04.2015 - Market Exclusivity
20.04.2020 given to Life Support
Pvt. Ltd.
817 P3470 FLUCONAZOLE Onlezole Pharmix Laboratories Pakistan Capsule 150 mg USP POM Re 21.04.2015 - Market Exclusivity
20.04.2020 given to Life Support
Pvt. Ltd.
818 P932 FLUNARIZINE Sibelium J&J, India Tablet 10 mg POM Re 08.09.2015- Market Exclusivity
07.09.2020 given to Mediquip
Maldives Pvt. Ltd.
819 P933 FLUNARIZINE Sibelium J&J, India Tablet 5mg POM Re 08.09.2015- Market Exclusivity
07.09.2020 given to Mediquip
Maldives Pvt. Ltd.
820 P3144 FLUNARIZINE Flunar 10 Cassel Research Laboratories, Tablet 10 mg POM R 19.08.2014 Registered by My
India Chemist Wholesale

821 P3143 FLUNARIZINE Flunar 5 Cassel Research Laboratories, Tablet 5 mg POM R 19.08.2014 Registered by My
India Chemist Wholesale

822 P2381 FLUOCINOLONE Supricort Glenmark , India Cream 0.025% POM R

823 P1099 FLUOCINOLONE Flucort Glenmark , India Cream 0.03% POM R Registered by ADK
Company Pvt Ltd
824 P860 FLUOCINOLONE Fluciderm Cream HOE Pharmaceutical Cream 0.025% W/W POM R Registered by Dial
Manufacturing (M) Sdn. Bhd., Trade and Travels Pte.
Malaysia Ltd.
825 P2342 FLUOCINOLONE + MICONAZOLE BP Flucort MZ Glenmark , India Ointment 0.01% + 2.0 % POM R 13.05.2010 Registered by ADK
Company Pvt Ltd

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 48 of 113 Authorized by:DG,MFDA
 826 P3715 FLUOROMETHOLONE USP Eyfem Remington Pharmaceutical Eye Drops 0.1% (1mg)/ml (5ml) POM Re 17.05.2016 - Market Exclusivity
Industries, Pakistan 16.05.2021 given to ADK
Pharmaceutical
Company Pvt. Ltd.
827 P4328 FLUOXETINE HYDROCHLORIDE USP Flexin SM Pharmaceuticals Sdn. Bhd. Capsule 20mg POM Re E 02.10.2018 - Market Exclusivity
Lot 88, Sungai Petani 01.10.2023 given to Green
Industrial Estate, 08000 Pharmacy Godown
Sungai Petani, Kedah,
Malaysia
828 P2385 FLUOXETINE USP Dawnex 20 Micro Labs ltd Tablet 20 mg POM R E 16.08.2010 Registered by ADK
Company Pvt Ltd
829 P1222 FLUROMETHOLONE + NAPHAZOLINE Efemoline Excelvision Ag Eye Drops 0.1%+0.025% POM R 12.02.2010 Registerd by State
Switzerland/Novartis Pharma Trading Organization
Ag Switzerland Plc.
830 P2421 FLUTAMIDE Cytomid Cipla India Tablet 250 mg POM R 07.10.2010 Registered by ADK
Company Pvt Ltd
831 P691 FLUTICASONE Cutivate Glaxo Wellcome , UK Cream 0.05% POM R E Registered by ADK
Company Pvt Ltd
832 P692 FLUTICASONE Cutivate Glaxo Wellcome , UK Topical Ointment 0.50% POM R E Registered by ADK
Company Pvt Ltd
833 P2235 FLUTICASONE Flutivate Cream GlaxoSmithKline, India Cream 0.05% POM R Registered by ADK
Company Pvt Ltd
834 P2234 FLUTICASONE Flutivate Ointment GlaxoSmithKline, India Ointment 0.50% POM R Registered by ADK
Company Pvt Ltd
835 P3722 FLUTICASONE Flusort Glenmark Pharmaceuticals Nasal Spray 50mcg(0.05%) BP/Spray POM Re 17.05.2016 - Market Exclusivity
Ltd, India (120MD) 16.05.2021 given to ADK
Pharmaceutical
Company Pvt. Ltd.
836 P2851 FLUTICASONE FUROATE Avamys Glaxo Operations UK Limited Nasal Spray 27.5 mcg/spray POM R 07.11.2013 Registered by ADK
Company Pvt Ltd
837 P2850 FLUTICASONE PROPIONATE Flomist Nasal Cipla India Nasal Spray 50 mcg/puff POM R 07.11.2013 Registered by ADK
Spray Company Pvt Ltd
838 P2314 FLUTICASONE PROPIONATE Flixonase GlaxoSmithKline, Nasal Spray 0.05% POM R 28.02.2010 Registered by ADK
Australia/Spain Company Pvt Ltd
839 P2882 FLUTICASONE PROPIONATE Flohale 125 Cipla India Oral Inhaler 125 mcg POM R 07.01.2014 Registered by ADK
Company Pvt Ltd
840 P3805 FLUTICASONE PROPIONATE BP Ticas Square Pharmaceuticals Ltd., Ointment 0.005% POM Re 11.10.2016- Market Exclusivity
Bangladesh 10.10.2021 given to Dial Trade
and Travels Pte. Ltd.
841 P3806 FLUTICASONE PROPIONATE BP Ticas Square Pharmaceuticals Ltd., Cream 0.05% (10g) POM Re 11.10.2016- Market Exclusivity
Bangladesh 10.10.2021 given to Dial Trade
and Travels Pte. Ltd.
842 P2156 FOLIC ACID Folic Acid Arvind Remedies Ltd, India Tablet 5 mg POM R E

843 P3748 FOLIC ACID Axcel Folic Acid Kotra Pharma, Malaysia Tablet 5 mg POM Re 30.08.2016 - Market Exclusivity
29.08.2021 given to State Trading
Organization Plc.

844 P3112 FOLIC ACID BP FOLIC ACID Hovid Bhd, Malaysia Tablet 5 mg POM R 20.05.2014 Registered by GKT
Pharmacy

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 49 of 113 Authorized by:DG,MFDA
 845 P2155 FOLIC ACID BP Megafit Arvind Remedies Ltd, India Tablet 5 mg POM R

846 P3551 FOLIC ACID BP Upha Folic Upha Pharmaceutical Tablet 5 mg POM Re 25.08.2015- Market Exclusivity
Manufacturing (M) Sdn. Bhd., 24.08.2020 given to Dial Trade
Malaysia and Travels Pte. Ltd.
847 P2516 FONDAPARINUX SODIUM Arixtra Glaxo Welcome , France Injection 2.5mg /0.5 ml POM R 23.06.2011 Registered by ADK
Company Pvt Ltd
848 P2881 FORMOTEROL FUMARATE + BUDESONIDE Foracort Cipla India Oral Inhaler 6 mcg +200 mcg per actuation POM R 07.01.2014 Registered by ADK
Company Pvt Ltd
849 P3711 FORMOTEROL FUMARATE Combiwave FB200 Glenmark Pharmaceuticals Inhalation Aerosol 6mcg BP+200 mcg POM Re 17.05.2016 - Market Exclusivity
DIHYDRATE+BUDESONIDE Ltd, India BP/Actuation (120 MD) 16.05.2021 given to ADK
Pharmaceutical
Company Pvt. Ltd.
850 P1807 FOSINOPRIL SODIUM Monopril Tablet Bristol Myers Squibb Pakistan Tablet 10mg POM R
10mg
851 P880 FRAMYCETIN IP Soframycin Sanofi India Ltd Cream 1% POM R E 29.08.2011 Registered by ADK
Company Pvt Ltd
852 P2780 FUSIDIC ACID Disuf Hovid Bhd, Malaysia Cream 2% OTC R 05.06.2013 Registered by GKT
Pharmacy
853 P2781 FUSIDIC ACID Disuf Hovid Bhd, Malaysia Ointment 2% OTC R 05.06.2013 Registered by GKT
Pharmacy
854 P4354 FUSIDIC ACID Defuzin Xepa-Soul Pattinson Cream 2% w/w (15g) POM Re E 16.10.2018 - Market Exclusivity
(Malaysia) SDN. BHD. 1-5 15.10.2023 given to ADK
Cheng Industrial Estate, 75250 Pharmaceutical
Melaka, Malaysia Company Pvt. Ltd.
855 P2852 FUSIDIC ACID + BETAMETHASONE Disuf B Cream Hovid Bhd, Malaysia Cream 2% + 0.1% POM R 07.11.2013 Registered by GKT
Pharmacy
856 P4434 FUSIDIC ACID + BETAMETHASONE Defuzin-B Xepa-Soul Pattinson Cream 2% w/w + 0.1% w/w (15g) POM Re 19.03.2019 - Market Exclusivity
(Malaysia) SDN. BHD. 1-5 18.03.2024 given to ADK
Cheng Industrial Estate, 75250 Pharmaceuticals
Melaka, Malaysia Company Pvt. Ltd.
857 P3536 FUSIDIC ACID + HYDROCORTISONE ACETATE Disuf -H Hovid Bhd. 121, Jalan Tunku Cream 2% + 1% w/w POM Re 19.05.2015- Market Exclusivity
Abdul Rahman, 30010 Ipoh, 18.05.2020 given to My Chemist
Malaysia Wholesale
858 P2513 FUSIDIC ACID BP Germacid Phamaniaga Manufacturing Cream 2% OTC R 25.05.2011 Registered by ADK
Berhad,Malaysia Company Pvt Ltd

859 P3207 GABAPENTIN Neuran Hovid Bhd, Malaysia Capsule 300 mg POM R E 06.11.2014 Registered by GKT
Pharmacy
860 P2387 GABAPENTIN Gabalept Micro Labs ltd Capsule 300 mg POM R E 16.08.2010 Registered by ADK
Company Pvt Ltd
861 P2775 GABAPENTIN Gaba Atoz Pharmaceuticals ,India Tablet 300 mg POM R E 05.06.2013 Registered by My
Chemist Wholesale

862 P3453 GABAPENTIN Gabapen 300 Incepta pharmaceuticals Tablet 300 mg USP POM Re E 24.03.2015 - Market Exclusivity
Limited, Bangladesh 23.03.2020 given to Dial Trade
and Travels Pte. Ltd.

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 50 of 113 Authorized by:DG,MFDA
 863 P3577 GABAPENTIN Penral CCL Pharmaceuticals, Capsule 100 mg USP POM Re E 06.10.2015- Market Exclusivity
Pakistan 05.10.2020 given to State Trading
Organization Plc.

864 P3578 GABAPENTIN Penral CCL Pharmaceuticals, Capsule 300 mg USP POM Re E 06.10.2015- Market Exclusivity
Pakistan 05.10.2020 given to State Trading
Organization Plc.

865 P3515 GABAPENTIN Gaba-100 Atoz Pharmaceuticals, India Table 100 mg POM Re E 19.05.2015- Market Exclusivity
18.05.2020 given to My Chemist
Wholesale
866 P3273 GATIFLOXACIN Loxiget Remington Pharmaceuticals, Eye Drops 0.3% POM R 06.01.2015 Registered by ADK
Pakistan Company Pvt Ltd

867 P3272 GATIFLOXACIN Loxiget Remington Pharmaceuticals, Eye Ointment 0.3% POM R 06.01.2015 Registered by ADK
Pakistan Company Pvt Ltd

868 P3501 GATIFLOXACIN Tag Aristo Pharma Limited, Eye Drops 0.3% POM Re 19.05.2015- Market Exclusivity
Bangladesh 18.05.2020 given to Life Support
Pvt. Ltd.
869 P4108 GEMCITABINE HYDROCHLORIDE USP Gemhope Glenmark Generics S.A Calle 9 Lyophilized 1g/vial(50ml) Restricted for R 21.11.2017 Registered
Ing. Meyer Oks N° 593 Parque powder for Hospital Use Only
Industrial Pilar Buenose Aires, Injection
Argentina

870 P4109 GEMCITABINE HYDROCHLORIDE USP Gemhope Glenmark Generics S.A Calle 9 Lyophilized 200mg/vial (5ml) Restricted for R 21.11.2017 Registered
Ing. Meyer Oks N° 593 Parque powder for Hospital Use Only
Industrial Pilar Buenose Aires, Injection
Argentina

871 P3110 GEMFIBROZIL LIPISTOROL Hovid Bhd, Malaysia Tablet 300 mg USP POM R 20.05.2014 Registered by GKT
Pharmacy
872 P2790 GEMIFLOXACIN Dugram Pharmix Laboratorie, Pakistan Tablet 320 mg POM R 05.06.2013 Registered by Life
Support Pvt Ltd
873 P53 GENTAMICIN BP Gentamycin Ambalal Sarabhai Injection 80 mg /2ml POM R E 26.04.2014 Registered by ADK
India/Assence Pharma Pvt Ltd Company Pvt Ltd

874 P873 GENTAMICIN SULPHATE Gentamicin Cream HOE Pharmaceutical Cream 0.17% w/w in 15 g POM R Registered by Dial
Manufacturing (M) Sdn. Bhd., Trade and Travels Pte.
Malaysia Ltd.
875 P1918 GENTAMICIN SULPHATE + Betagen Eye/ Ear Upha Pharmaceutical Ear/Eye Drops 0.3% + 0.1% POM R
BETAMETHASONE SODIUM PHOSPHATE Drops Manufacturing (M) Sdn. Bhd.,
Malaysia
876 P2419 GENTAMICIN SULPHATE USP + Betagel - G Micro Labs ltd Topical Gel 0.064%w/w + 0.1% POM R 06.10.2010 Registered by ADK
BETAMETHASONE DIPROPIONATE Company Pvt Ltd
877 P4129 GINSENG EXTRACT , BETACAROTENE Ginsomin Mega Life Sciences Capsule 50 mg +6 mg, 200IU + 2 mg, OTC R Registered by ADK
,VITAMIN D3 , VITAMIN B1, VITAMIN B 12 , Ltd,Thailand 2mcg + 60mg + 15 IU+ 20mg + Company Pvt Ltd
VIT C ,VIT E , NICOTINAMIDE , FOLIC ACID 200 mcg + 2mg + 5 mg
,COPPER , ZINC
878 P1674 GLIBENCLAMIDE Semi-Glyboral USV, India Tablet 2.5 mg POM R E

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 51 of 113 Authorized by:DG,MFDA
 879 P1675 GLIBENCLAMIDE Glyboral USV, India Tablet 5 mg POM R E
880 P2152 GLIBENCLAMIDE BP Gliben 5 Arvind Remedies Ltd, India Tablet 5 mg POM R E

881 P2239 GLIBENCLAMIDE IP Glybovin 5 Aristo India Tablet 5 mg POM R Registered by ADK
Company Pvt Ltd
882 P68 GLICLAZIDE Glycigon Aristo India Tablet 80mg POM R E Registered by ADK
Company Pvt Ltd
883 P2284 GLICLAZIDE Glyfix Saga Laboratories, India Tablet 80 mg POM R E Registered by Dial
Trade and Travels Pte.
Ltd.
884 P2241 GLICLAZIDE Semi Glycigon Aristo India Tablet 40 mg POM R E Registered by ADK
Company Pvt Ltd
885 P2276 GLICLAZIDE Nidonil Merck Marker, Pakistan Tablet 80 mg POM R E Registered by ADK
Company Pvt Ltd
886 P1653 GLICLAZIDE Diatica Unique, India Tablet 80mg POM R E Registered by ADK
Company Pvt Ltd
887 P1141 GLICLAZIDE Glucozid Medley Ltd, India. Tablet 80 mg POM R E Registered By ADK
Company Pvt Ltd
888 P2132 GLICLAZIDE Gliclaz Khandelwal Laboratories Pvt Tablet 80 mg POM R E
Ltd
889 P1676 GLICLAZIDE Glycor USV, India Tablet 80mg POM R
890 P2017 GLICLAZIDE Gored General Pharmacueticals Tablet 80 mg POM R E
Ltd,Bangladesh
891 P1897 GLICLAZIDE Comprid Square Pharmaceuticals, Tablet 80 mg POM R E
Bangladesh
892 P3808 GLICLAZIDE Pharmaniaga Pharmaniaga Manufacturing Tablet 80mg POM Re 11.10.2016- Market Exclusivity
Gliclazide Berhad, 11A, Jalan P/1, 10.10.2021 given to Dial Trade
Kawasan Perusahaan Bangi, and Travels Pte. Ltd.
43650 Bandar Baru Bangi,
Selangor Darul Ehsan,
Malaysia

893 P3523 GLICLAZIDE Glitab-80 BP Atoz Pharmaceuticals, India Tablet 80 mg POM Re 19.05.2015- Market Exclusivity
18.05.2020 given to My Chemist
Wholesale
894 P2418 GLICLAZIDE + METFORMIN Glycigon - M Aristo India Tablet 80 mg + 500 mg POM R 07.10.2010 Registered By ADK
Company Pvt Ltd
895 P2133 GLICLAZIDE + METFORMIN Gliclaz M Khandelwal Laboratories Pvt Tablet 80mg + 500 mg POM R
Ltd
896 P2644 GLICLAZIDE + METFORMIN BP Glucozid M Medley Ltd, India. Tablet 80mg + 500 mg POM R 02.10.2012 Registered By ADK
Company Pvt Ltd
897 P2665 GLICLAZIDE BP Glimicron Hovid Bhd, Malaysia Tablet 80mg POM R E 27.11.2012 Registered by GKT
Pharmacy
898 P2317 GLIMEPIRIDE Amaryl Sanofi India Ltd Tablet 1 mg POM R 21.03.2010 Registered By ADK
Company Pvt Ltd
899 P2318 GLIMEPIRIDE Amaryl Sanofi India Ltd Tablet 2 mg POM R 21.03.2014 Registered By ADK
Company Pvt Ltd
900 P2319 GLIMEPIRIDE Amaryl Sanofi India Ltd Tablet 3 mg POM R 21.03.2014 Registered By ADK
Company Pvt Ltd

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 52 of 113 Authorized by:DG,MFDA
 901 P2253 GLIMEPIRIDE Losucon 1 Incepta pharmaceuticals Tablet 1mg POM R Registered by Dial
Limited, Bangladesh Trade and Travels Pte.
Ltd.
902 P2254 GLIMEPIRIDE Losucon 2 Incepta pharmaceuticals Tablet 2mg POM R Registered by Dial
Limited, Bangladesh Trade and Travels Pte.
Ltd.
903 P3113 GLIMEPIRIDE Glimaryl Hovid Bhd, Malaysia Tablet 2mg POM R 20.05.2014 Registered by GKT
Pharmacy
904 P1143 GLIMEPIRIDE Gepride Medley Ltd, India. Tablet 2 mg POM R Registered By ADK
Company Pvt Ltd
905 P1144 GLIMEPIRIDE Gepride Medley Ltd, India. Tablet 3 mg POM R Registered By ADK
Company Pvt Ltd
906 P3513 GLIMEPIRIDE + METFORMIN HCL IP Gepride M1 Medley Ltd, India. Tablet 1 mg + 500mg POM Re 19.05.2015- Market Exclusivity
18.05.2020 given to ADK Company
Pvt. Ltd.
907 P3514 GLIMEPIRIDE + METFORMIN HCL IP Gepride M2 Medley Ltd, India. Tablet 2mg + 500mg POM Re 19.05.2015- Market Exclusivity
18.05.2020 given to ADK Company
Pvt. Ltd.
908 P2712 GLIMEPIRIDE BP Azulix Torrent Pharmaceuticals, Tablet 1 mg POM R 19.02.2013 Registered by Life
India Support Pvt Ltd
909 P2713 GLIMEPIRIDE BP Azulix Torrent Pharmaceuticals, Tablet 2 mg POM R 19.02.2013 Registered by Life
India Support Pvt Ltd
910 P2714 GLIMEPIRIDE BP Azulix Torrent Pharmaceuticals, Tablet 4 mg POM R 19.02.2013 Registered by Life
India Support Pvt Ltd
911 P3525 GLIMEPIRIDE BP Glimetoz-4 Atoz Pharmaceuticals, India Tablet 4 mg POM Re 19.05.2015- Market Exclusivity
18.05.2020 given to My Chemist
Wholesale
912 P3526 GLIMEPIRIDE BP Glimetoz-2 Atoz Pharmaceuticals, India Tablet 2 mg POM Re 19.05.2015- Market Exclusivity
18.05.2020 given to My Chemist
Wholesale
913 P3530 GLIMEPIRIDE BP Glimetoz-1 Atoz Pharmaceuticals, India Tablet 1 mg POM Re 19.05.2015- Market Exclusivity
18.05.2020 given to My Chemist
Wholesale
914 P1142 GLIMEPIRIDE IP Gepride Medley Ltd, India. Tablet 1 mg POM R Registered By ADK
Company Pvt Ltd
915 P2482 GLIMEPIRIDE USP Gimetab MMC Health Care Ltd,India Tablet 1 mg POM R 23.02.2011 Registered by Green
Pharmacy
916 P2483 GLIMEPIRIDE USP Gimetab MMC Health Care Ltd,India Tablet 2 mg POM R 23.02.2011 Registered by Green
Pharmacy
917 P3126 GLIMEPIRIDE USP Glimulin 2 Glenmark , India Tablet 2 mg POM R E 08.07.2014 Registered By ADK
Company Pvt Ltd
918 P3125 GLIMEPIRIDE USP Glimulin 1 Glenmark , India Tablet 1 mg POM R E 08.07.2014 Registered By ADK
Company Pvt Ltd
919 P2228 GLIMEPIRIDE USP Diapride 2 Micro Labs ltd Tablet 2 mg POM R Registered By ADK
Company Pvt Ltd
920 P1145 GLIMEPIRIDE USP Gepride Medley Ltd, India. Tablet 4 mg POM R Registered By ADK
Company Pvt Ltd

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 53 of 113 Authorized by:DG,MFDA
 921 P3660 GLIMEPRIRIDE Orinase 1 CCL Pharmaceuticals, Film Coated Tablet 1 mg POM Re 21.01.2016 - Market Exclusivity
Pakistan 20.01.2021 given to State Trading
Organization Plc.

922 P3661 GLIMEPRIRIDE Orinase 4 CCL Pharmaceuticals, Film Coated Tablet 4 mg POM Re 21.01.2016 - Market Exclusivity
Pakistan 20.01.2021 given to State Trading
Organization Plc.

923 P1677 GLIPIZIDE Semi-Glynase USV, India Tablet 2.5mg POM R

924 P1678 GLIPIZIDE Glynase USV, India Tablet 5mg POM R
925 P1944 GLIPIZIDE Glide Franco Indian Remedies Pvt Tablet 5 mg POM R
Ltd India
926 P2281 GLIPIZIDE BP Euglizip Astron Limited, Sri Lanka Tablet 5 mg POM R Registered By ADK
Company Pvt Ltd
927 P2909 GLUCOSAMINE Cartril-S Upha Pharmaceutical Sachet 1500 mg OTC R 18.02.2014 Registered by Dial
Manufacturing (M) Sdn. Bhd., Trade and Travels Pte.
Malaysia Ltd.
928 P2807 GLUCOSAMINE SULPHATE + CHONDROITIN Jointace Sport Vitabiotics Ltd ,UK Tablet 500 mg+50 mg+ 20 mg+ 5 OTC R 26.08.2013 Registered by Life
SULPHATE + VITAMIN E + VITAMIN D3 + Tablet mcg+ 10 mcg + 20 mcg + 5 mg Support Pvt Ltd
VITAMIN B12 + FOLIC ACID + ZINC + COPPER + 0.5 mg+2 mg + 40 mg +100
+MANGA NESE + GINGER EXTRACT + mg + 50 mg
BROMELAIN + HYALURONIC

929 P3591 GLUCOSAMINE SULFATE POTASSIUM Cartiplus Forte MMC Healthcare Ltd. No.34- Film Coated Tablet 750 mg + 100 mg + 200 mg + POM Re 27.10.2015- Market Exclusivity
CHLORIDE USP + CHONDROITIN SULFATE B, SIDCO Industrial Estate, 250mg + 200IU 26.10.2020 given to Green
SODIUM USP + METHYL SULFONYL Thirumazhisai, Chennai - 600 Pharmacy Godown
METHANE USP + CALCIUM CARBONATE BP 124, India
+ COLECALCIFEROL BP
930 P3205 GLUCOSAMINE SUlPHATE + CHONDROITIN Cosamine Plus Hovid Bhd, Malaysia Capsule 250 mg + 200 mg OTC R 06.11.2014 Registered by GKT
Pharmacy

931 P2808 GLUCOSAMINE SUlPHATE + CHONDROITIN Ultra Glucosamin Vitabiotics Ltd ,UK Tablet 500 mg + 400 mg OTC R 26.08.2013 Registered by Life
and Chondroitin Support Pvt Ltd

932 P3149 GLUCOSAMINE SULPHATE + Jointact Atoz Pharmaceuticals ,India Tablet 750 mg + 200 mg + 16 mg +20 OTC R 19.08.2014 Registered by My
METHYLSULFONYLMETHANE + VITAMIN E + mg Chemist Wholesale
MANGANESE
933 P3122 GLUCOSAMINE SULPHATE SODIUM + Jointace Gel Vitabiotics Ltd ,UK Gel 5%+ 1% OTC R 08.07.2014 Registered by Life
CHONDROITIN SULPHATE SODIUM Support Pvt Ltd

934 P2392 GLUCOSAMINE SUlPHATE USP CARTIPLUS 750 MMC Health Care Ltd,India Capsule 750 mg OTC R

935 P3123 GLUCOSAMINE SUlPHATE USP Ultra Glucosamin Vitabiotics Ltd ,UK Tablet 750 mg OTC R 08.07.2014 Registered by Life
Support Pvt Ltd

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 54 of 113 Authorized by:DG,MFDA
 936 P3640 GLUCOSE 11% 1180 ML CONTAIN: (1) Kabiven Peripheral Fresnius kabi AB, S-75174 Intravenous (1) Glucose 11% 1180 ml Restricted for Re 15.08.2017 Market Exclusivity
GLUCOSE (ANHYDROUS) PH. EUR. 130G, 1400 kcal Uppsala, Sweden emulsion for contain: Glucose (anhydrous) Hospital use only 14.08.2022 given to State Trading
WATER FOR INJECTIONS PH. EUR TO 1180 Infusion Ph. Eur. 130g, Water for Each Organization Plc.
ML. VAMIN ® 18 NOVUM 400ML CONTAIN: injections Ph. Eur to 1180 ml. Shipment
(2) ALANINE PH.EUR. 6.4G, ARGININE (2) Vamin ® 18 Novum should be
PH.EUR. 4.5G, ASPARTIC ACID PH.EUR. 400ml contain: Alanine accompanied
1.4.0G, GLUTAMIC ACID PH.EUR. 2.2G, Ph.Eur. 6.4g, Arginine Ph.Eur. by the batch
GLYCINE PH.EUR. 3.2G, HISTIDINE PH.EUR. 4.5g, Aspartic acid Ph.Eur. certificates
2.7G, ISOLEUCINE PH.EUR. 2.2G, LEUCINE 1.4.0g, Glutamic acid Ph.Eur.
PH.EUR. 3.2G,LYSINE HYDROCHLORIDE 2.2g, Glycine Ph.Eur. 3.2g,
PH.EUR. CORRESPONDING TO LYSINE 3.6G, Histidine Ph.Eur. 2.7g,
METHIONINE PH.EUR. 2.2G, Isoleucine Ph.Eur. 2.2g,
PHENYLALANINE PH. EUR. 3.2G, PROLINE Leucine Ph.Eur. 3.2g,Lysine
PH.EUR. 2.7G, SERINE PH.EUR. 1.8G, hydrochloride Ph.Eur.
THREONINE PH.EUR.2.2G, TRYPTOPHAN corresponding to Lysine 3.6g,
PH.EUR.0.76G, TYROSINE PH.EUR. 0.09G, Methionine Ph.Eur. 2.2g,
VALINE PH.EUR. 2.9G. CALCIUM CHLORIDE Phenylalanine Ph. Eur. 3.2g,
2H2O PH.EUR. CORRESPONDING TO Proline Ph.Eur. 2.7g, Serine
CALCIUM CHLORIDE 0.30G, SODIUM Ph.Eur. 1.8g, Threonine
GLYCEROPHOSPHATE Ph.Eur.2.2g, Tryptophan
PH.FRANC.CORRESPONDING TO SODIUM Ph.Eur.0.76g, Tyrosine Ph.Eur.
GLYCEROPHOSPHATE (ANHYDROUS) 0.64G, 0.09g, Valine Ph.Eur. 2.9g.
MAGNESIUM SULPHATE 7H2O PH.EUR. Calcium chloride 2H2O Ph.Eur.
CORRESPONDING TO MAGNESIUM corresponding to Calcium
SULPHATE 0.64G, POTASSIUM CHLORIDE chloride 0.30g, Sodium
PH.EUR. 2.4G, SODIUM ACETATE 3H2O glycerophosphate
PH.EUR. CORRESPONDING TO SODIUM Ph.Franc.corresponding to
ACETATE 2.0G, WATER FOR INJECTIONS Sodium glycerophosphate
PH.EUR. TO 400ML. GLACIAL ACETIC ACID (anhydrous) 0.64g, Magnesium
PH.EUR. Q.S.TO PH APPROX. 5.6. sulphate 7H2O Ph.Eur.
INTRALIPID ® 20% 340ML CONTAIN: (3) corresponding to Magnesium
SOYBEAN OIL PH.EUR. 68G, PURIFIED EGG sulphate 0.64g, Potassium
PHOSPHOLIPIDS 4.1G, GLYCEROL chloride Ph.Eur. 2.4g, Sodium
(ANHYDROUS) PH.EUR. 7.5G, WATER FOR acetate 3H2O Ph.Eur.

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 55 of 113 Authorized by:DG,MFDA
 937 P3639 GLUCOSE 11% 885 ML CONTAIN:(1) Kabiven Peripheral Fresnius kabi AB, S-75174 Intravenous (1) Glucose 11% 885 ml Restricted for Re 15.08.2017 Market Exclusivity
GLUCOSE (ANHYDROUS) PH. EUR. 97G, 1000 kcal Uppsala, Sweden emulsion for contain: Glucose (anhydrous) Hospital use only 14.08.2022 given to State Trading
WATER FOR INJECTIONS PH. EUR TO 885 Infusion Ph. Eur. 97g, Water for Each Organization Plc.
ML. VAMIN ® 18 NOVUM 300ML CONTAIN: injections Ph. Eur to 885 ml. Shipment
(2) ALANINE PH.EUR. 4.8G, ARGININE (2) Vamin ® 18 Novum 300ml should be
PH.EUR. 3.4G, ASPARTIC ACID PH.EUR. 1.0G, contain: Alanine Ph.Eur. 4.8g, accompanied
GLUTAMIC ACID PH.EUR. 1.7G, GLYCINE Arginine Ph.Eur. 3.4g, Aspartic by the batch
PH.EUR. 2.4G, HISTIDINE PH.EUR. 2.0G, acid Ph.Eur. 1.0g, Glutamic certificates
ISOLEUCINE PH.EUR. 1.7G, LEUCINE PH.EUR. acid Ph.Eur. 1.7g, Glycine
2.4G, LYSINE HYDROCHLORIDE PH.EUR. Ph.Eur. 2.4g, Histidine Ph.Eur.
2.4G, LYSINE HYDROCHLORIDE PH.EUR. 2.0g, Isoleucine Ph.Eur. 1.7g,
CORRESPONDING TO LYSINE 2.7G, Leucine Ph.Eur. 2.4g, Lysine
METHIONINE PH.EUR. 1.7G, hydrochloride Ph.Eur. 2.4g,
PHENYLALANINE PH. EUR. 2.4G, PROLINE Lysine hydrochloride Ph.Eur.
PH.EUR. 2.0G, SERINE PH.EUR. 1.4G, corresponding to Lysine 2.7g,
THREONINE PH.EUR.1.7G, TRYPTOPHAN Methionine Ph.Eur. 1.7g,
PH.EUR.0.57G, TYROSINE PH.EUR. 0.07G, Phenylalanine Ph. Eur. 2.4g,
VALINE PH.EUR. 2.2G. CALCIUM CHLORIDE Proline Ph.Eur. 2.0g, Serine
2H2O PH.EUR. CORRESPONDING TO Ph.Eur. 1.4g, Threonine
CALCIUM CHLORIDE 0.22G, SODIUM Ph.Eur.1.7g, Tryptophan
GLYCEROPHOSPHATE Ph.Eur.0.57g, Tyrosine Ph.Eur.
PH.FRANC.CORRESPONDING TO SODIUM 0.07g, Valine Ph.Eur. 2.2g.
GLYCEROPHOSPHATE (ANHYDROUS) 1.5G, Calcium chloride 2H2O Ph.Eur.
MAGNESIUM SULPHATE 7H2O PH.EUR. corresponding to Calcium
CORRESPONDING TO MAGNESIUM chloride 0.22g, Sodium
SULPHATE 0.48G, POTASSIUM CHLORIDE glycerophosphate
PH.EUR. 1.8G, SODIUM ACETATE 3H2O Ph.Franc.corresponding to
PH.EUR. CORRESPONDING TO SODIUM Sodium glycerophosphate
ACETATE 1.5G, WATER FOR INJECTIONS (anhydrous) 1.5g, Magnesium
PH.EUR. TO 300ML. GLACIAL ACETIC ACID sulphate 7H2O Ph.Eur.
PH.EUR. Q.S.TO PH APPROX. 5.6. corresponding to Magnesium
INTRALIPID ® 20% 255ML CONTAIN: (3) sulphate 0.48g, Potassium
PURIFIED SOYBEAN OIL PH.EUR. 51G, chloride Ph.Eur. 1.8g, Sodium
PURIFIED EGG PHOSPHOLIPIDS 3.1G, acetate 3H2O Ph.Eur.

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 56 of 113 Authorized by:DG,MFDA
 938 P3643 GLUCOSE 19% 1053 ML CONTAINS: (1) Kabiven 1900 kcal Fresnius kabi AB, S-75174 Intravenous (1) Glucose 19% 1053 ml Restricted for Re 15.08.2017 - Market Exclusivity
GLUCOSE (ANHYDROUS) PH. EUR. 200G, Uppsala, Sweden emulsion for contains: Glucose (anhydrous) Hospital use only 14.08.2022 given to State Trading
WATER FOR INJECTIONS PH. EUR TO 1053 Infusion Ph. Eur. 200g, Water for Each Organization Plc.
ML. VAMIN ® 18 NOVUM 600ML CONTAINS: injections Ph. Eur to 1053 ml. Shipment
(2) ALANINE PH.EUR. 9.6G, ARGININE (2) Vamin ® 18 Novum 600ml should be
PH.EUR. 6.8G, ASPARTIC ACID PH.EUR. 2.0G, contains: Alanine Ph.Eur. 9.6g, accompanied
GLUTAMIC ACID PH.EUR. 3.4G, GLYCINE Arginine Ph.Eur. 6.8g, Aspartic by the batch
PH.EUR. 4.7G, HISTIDINE PH.EUR. 4.1G, acid Ph.Eur. 2.0g, Glutamic certificates
ISOLEUCINE PH.EUR. 3.4G, LEUCINE PH.EUR. acid Ph.Eur. 3.4g, Glycine
4.7G, LYSINE HYDROCHLORIDE PH.EUR. Ph.Eur. 4.7g, Histidine Ph.Eur.
CORRESPONDING TO LYSINE 5.4G, 4.1g, Isoleucine Ph.Eur. 3.4g,
METHIONINE PH.EUR. 3.4G, Leucine Ph.Eur. 4.7g, Lysine
PHENYLALANINE PH. EUR. 4.7G, PROLINE hydrochloride Ph.Eur.
PH.EUR. 4.1G, SERINE PH.EUR. 2.7G, corresponding to Lysine 5.4g,
THREONINE PH.EUR.3.4G, TRYPTOPHAN Methionine Ph.Eur. 3.4g,
PH.EUR.1.1G, TYROSINE PH.EUR. 0.14G, Phenylalanine Ph. Eur. 4.7g,
VALINE PH.EUR. 4.4G. CALCIUM CHLORIDE Proline Ph.Eur. 4.1g, Serine
2H2O PH.EUR. CORRESPONDING TO Ph.Eur. 2.7g, Threonine
CALCIUM CHLORIDE 0.44G, SODIUM Ph.Eur.3.4g, Tryptophan
GLYCEROPHOSPHATE Ph.Eur.1.1g, Tyrosine Ph.Eur.
PH.FRANC.CORRESPONDING TO SODIUM 0.14g, Valine Ph.Eur. 4.4g.
GLYCEROPHOSPHATE (ANHYDROUS) 3.0G, Calcium chloride 2H2O Ph.Eur.
MAGNESIUM SULPHATE 7H2O PH.EUR. corresponding to Calcium
CORRESPONDING TO MAGNESIUM chloride 0.44g, Sodium
SULPHATE 0.96G, POTASSIUM CHLORIDE glycerophosphate
PH.EUR. 3.6G, SODIUM ACETATE 3H2O Ph.Franc.corresponding to
PH.EUR. CORRESPONDING TO SODIUM Sodium glycerophosphate
ACETATE 2.9G, WATER FOR INJECTIONS (anhydrous) 3.0g, Magnesium
PH.EUR. TO 600ML. GLACIAL ACETIC ACID sulphate 7H2O Ph.Eur.
PH.EUR. Q.S.TO PH APPROX. 5.6. corresponding to Magnesium
INTRALIPID ® 20% 400ML CONTAINS: (3) sulphate 0.96g, Potassium
PURIFIED SOYBEAN OIL PH.EUR. 80G, chloride Ph.Eur. 3.6g, Sodium
PURIFIED EGG PHOSPHOLIPIDS 4.8G, acetate 3H2O Ph.Eur.
GLYCEROL (ANHYDROUS) PH.EUR. 8.8G, corresponding to Sodium

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 57 of 113 Authorized by:DG,MFDA
 939 P4004 GLUCOSE 19% 526 ML CONTAINS: (1) Kabiven 900 kcal Fresnius kabi AB, S-75174 Intravenous (1) Glucose 19% 526 ml Restricted for Re 15.08.2017 Market Exclusivity
GLUCOSE (ANHYDROUS) PH. EUR. 100G, Uppsala, Sweden emulsion for contains: Glucose (anhydrous) Hospital use only 14.08.2022 given to State Trading
WATER FOR INJECTIONS PH. EUR TO 526 Infusion Ph. Eur. 100g, Water for Each Organization Plc.
ML. VAMIN ® 18 NOVUM 300ML CONTAINS: injections Ph. Eur to 526 ml. Shipment
(2) ALANINE PH.EUR. 4.8G, ARGININE (2) Vamin ® 18 Novum 300ml should be
PH.EUR. 3.4G, ASPARTIC ACID PH.EUR. 1.0G, contains: Alanine Ph.Eur. 4.8g, accompanied
GLUTAMIC ACID PH.EUR. 1.7G, GLYCINE Arginine Ph.Eur. 3.4g, Aspartic by the batch
PH.EUR. 2.4G, HISTIDINE PH.EUR. 2.0G, acid Ph.Eur. 1.0g, Glutamic certificates
ISOLEUCINE PH.EUR. 1.7G, LEUCINE PH.EUR. acid Ph.Eur. 1.7g, Glycine
2.4G, LYSINE HYDROCHLORIDE PH.EUR. Ph.Eur. 2.4g, Histidine Ph.Eur.
2.4G, LYSINE HYDROCHLORIDE PH.EUR. 2.0g, Isoleucine Ph.Eur. 1.7g,
CORRESPONDING TO LYSINE 2.7G, Leucine Ph.Eur. 2.4g, Lysine
METHIONINE PH.EUR. 1.7G, hydrochloride Ph.Eur. 2.4g,
PHENYLALANINE PH. EUR. 2.4G, PROLINE Lysine hydrochloride Ph.Eur.
PH.EUR. 2.0G, SERINE PH.EUR. 1.4G, corresponding to Lysine 2.7g,
THREONINE PH.EUR.1.7G, TRYPTOPHAN Methionine Ph.Eur. 1.7g,
PH.EUR.0.57G, TYROSINE PH.EUR. 0.07G, Phenylalanine Ph. Eur. 2.4g,
VALINE PH.EUR. 2.2G. CALCIUM CHLORIDE Proline Ph.Eur. 2.0g, Serine
2H2O PH.EUR. CORRESPONDING TO Ph.Eur. 1.4g, Threonine
CALCIUM CHLORIDE 0.22G, SODIUM Ph.Eur.1.7g, Tryptophan
GLYCEROPHOSPHATE Ph.Eur.0.57g, Tyrosine Ph.Eur.
PH.FRANC.CORRESPONDING TO SODIUM 0.07g, Valine Ph.Eur. 2.2g.
GLYCEROPHOSPHATE (ANHYDROUS) 1.5G, Calcium chloride 2H2O Ph.Eur.
MAGNESIUM SULPHATE 7H2O PH.EUR. corresponding to Calcium
CORRESPONDING TO MAGNESIUM chloride 0.22g, Sodium
SULPHATE 0.48G, POTASSIUM CHLORIDE glycerophosphate
PH.EUR. 1.8G, SODIUM ACETATE 3H2O Ph.Franc.corresponding to
PH.EUR. CORRESPONDING TO SODIUM Sodium glycerophosphate
ACETATE 1.5G, WATER FOR INJECTIONS (anhydrous) 1.5g, Magnesium
PH.EUR. TO 300ML. GLACIAL ACETIC ACID sulphate 7H2O Ph.Eur.
PH.EUR. Q.S.TO PH APPROX. 5.6. corresponding to Magnesium
INTRALIPID ® 20% 200ML CONTAINS: (3) sulphate 0.48g, Potassium
PURIFIED SOYBEAN OIL PH.EUR. 40G, chloride Ph.Eur. 1.8g, Sodium
PURIFIED EGG PHOSPHOLIPIDS 2.4G, acetate 3H2O Ph.Eur.

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 58 of 113 Authorized by:DG,MFDA
 940 P4003 GLUCOSE 19% 790 ML CONTAINS: (1) Kabiven 1400 kcal Fresnius kabi AB, S-75174 Intravenous (1) Glucose 19% 790 ml Restricted for Re 15.08.2017 Market Exclusivity
GLUCOSE (ANHYDROUS) PH. EUR. 150G, Uppsala, Sweden emulsion for contains: Glucose (anhydrous) Hospital use only 14.08.2022 given to State Trading
WATER FOR INJECTIONS PH. EUR TO 790 Infusion Ph. Eur. 150g, Water for Each Organization Plc.
ML. VAMIN ® 18 NOVUM 450ML CONTAINS: injections Ph. Eur to 790 ml. Shipment
(2) ALANINE PH.EUR. 7.2G, ARGININE (2) Vamin ® 18 Novum 450ml should be
PH.EUR. 5.1G, ASPARTIC ACID PH.EUR. 1.5G, contains: Alanine Ph.Eur. 7.2g, accompanied
GLUTAMIC ACID PH.EUR. 2.5G, GLYCINE Arginine Ph.Eur. 5.1g, Aspartic by the batch
PH.EUR. 3.6G, HISTIDINE PH.EUR. 3.1G, acid Ph.Eur. 1.5g, Glutamic certificates
ISOLEUCINE PH.EUR. 2.5G, LEUCINE PH.EUR. acid Ph.Eur. 2.5g, Glycine
3.6G, LYSINE HYDROCHLORIDE PH.EUR. Ph.Eur. 3.6g, Histidine Ph.Eur.
CORRESPONDING TO LYSINE 4.1G, 3.1g, Isoleucine Ph.Eur. 2.5g,
METHIONINE PH.EUR. 2.5G, Leucine Ph.Eur. 3.6g, Lysine
PHENYLALANINE PH. EUR. 3.6G, PROLINE hydrochloride Ph.Eur.
PH.EUR. 3.1G, SERINE PH.EUR. 2.0G, corresponding to Lysine 4.1g,
THREONINE PH.EUR.2.5G, TRYPTOPHAN Methionine Ph.Eur. 2.5g,
PH.EUR.0.86G, TYROSINE PH.EUR. 0.10G, Phenylalanine Ph. Eur. 3.6g,
VALINE PH.EUR. 3.3G. CALCIUM CHLORIDE Proline Ph.Eur. 3.1g, Serine
2H2O PH.EUR. CORRESPONDING TO Ph.Eur. 2.0g, Threonine
CALCIUM CHLORIDE 0.33G, SODIUM Ph.Eur.2.5g, Tryptophan
GLYCEROPHOSPHATE Ph.Eur.0.86g, Tyrosine Ph.Eur.
PH.FRANC.CORRESPONDING TO SODIUM 0.10g, Valine Ph.Eur. 3.3g.
GLYCEROPHOSPHATE (ANHYDROUS) 2.3G, Calcium chloride 2H2O Ph.Eur.
MAGNESIUM SULPHATE 7H2O PH.EUR. corresponding to Calcium
CORRESPONDING TO MAGNESIUM chloride 0.33g, Sodium
SULPHATE 0.72G, POTASSIUM CHLORIDE glycerophosphate
PH.EUR. 2.7G, SODIUM ACETATE 3H2O Ph.Franc.corresponding to
PH.EUR. CORRESPONDING TO SODIUM Sodium glycerophosphate
ACETATE 2.2G, WATER FOR INJECTIONS (anhydrous) 2.3g, Magnesium
PH.EUR. TO 450ML. GLACIAL ACETIC ACID sulphate 7H2O Ph.Eur.
PH.EUR. Q.S.TO PH APPROX. 5.6. (3) corresponding to Magnesium
INTRALIPID ® 20% 300ML CONTAINS: sulphate 0.72g, Potassium
PURIFIED SOYBEAN OIL PH.EUR. 60G, chloride Ph.Eur. 2.7g, Sodium
PURIFIED EGG PHOSPHOLIPIDS 3.6G, acetate 3H2O Ph.Eur.
GLYCEROL (ANHYDROUS) PH.EUR. 6.6G, corresponding to Sodium
941 P1146 GLYCERYL TRINITRATE GTN Spray Medley Ltd, India. Spray 0.4mg/MD POM R Registered By ADK
Company Pvt Ltd
942 P2257 GLYCOLIC ACID Glyco A Cream Micro Labs ltd Cream 12% POM R Registered By ADK
Company Pvt Ltd
943 P2735 GLYCOPYRROLATE Pyrolate Neon Laboratories, India Injection 0.2 mg in 1ml Restricted for R 16.04.2013 Registerd by State
Hospital use only Trading Organization
Plc.
944 P3262 GLYCOPYRRONIUM Seebri Breezhaler Novartis Pharma, Switzerland Inhalation Capsule 50 mcg POM R 06.01.2015 Registered by
Mediquip Maldives
Pvt. Ltd.
945 P3263 GLYCOPYRRONIUM BROMIDE + Ultibro Breezhaler Novartis Pharma, Switzerland Inhalation Capsule 50 mcg + 110 mcg POM R 06.01.2015 Registered by
INDACATEROL Mediquip Maldives
Pvt. Ltd.

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 59 of 113 Authorized by:DG,MFDA
 946 P4349 GRANISETRON HYDROCHLORIDE Emenat 1 Natco Pharma Limited Kothur- Tablet 1mg POM Re 02.10.2018 - Market Exclusivity
509 228, Rangareddy District 01.10.2023 given to ADK
Talangana, India Pharmaceutical
Company Pvt. Ltd.
947 P2211 GRISEOFULVIN Fulvin 250 Medopharm, India Tablet 250 mg POM R E Registered by Green
Pharmacy
948 P3554 GRISEOFULVIN Krisovin 500 Upha Pharmaceutical Tablet 500 mg POM Re 25.08.2015- Market Exclusivity
Manufacturing (M) Sdn. Bhd. 24.08.2020 given to Dial Trade
Lot 2 & 4, Jalan p/7, Seksyen and Travels Pte. Ltd.
13, Kawasan Perusahaan
Bangi, 43650 Bandar Baru
Bangi, Selangor Darul Ehsan,
Malaysia

949 P2294 H1N1 VACCINE H1N1 Vaccine GlaxoSmithKline injection POM R Registered By ADK
Company Pvt Ltd
950 P2141 HAEMOPHILUS INFLUENZAE Type B Vaccine Hiberix Vaccine Glaxo Smithkline Biologicals Injection 10 mcg POM R

951 P3800 HEPARIN SODIUM Unihepa Duopharma (M) Sdn. Injection 5000IU/ml in 5ml vial POM Re 11.10.2016- Market Exclusivity
Malaysia 10.10.2021 given to Dial Trade
and Travels Pte. Ltd.
952 P4335 HEPARIN SODIUM (BOVINE MUCOSA) + Vaxcel Heparin Kotra Pharma (M) Sdn. Bhd., Sterile solution for 5000 I.U./ml (5ml) POM Re E 02.10.2018 - Market Exclusivity
Benzyl Alcohol (as a preservative) Sodium 1, 2 & 3 Jalan TTC 12, Cheng injection 01.10.2023 given to State Trading
Industrial Estate, 75250, Organization Plc.
Malaka, Malaysia

953 P2372 HEPATITIS A + HEPATITIS B Twinrix Vaccine GlaxoSmithKline, Belgium Vaccine POM R 05.07.2010 Registered By ADK
Adult Company Pvt Ltd
954 P1541 HUMAN ALBUMIN HUMAN ALBUMIN Kedrion Biopharma,Italy Injection 20% (200 g/litre) Restricted for R
Hospital use only

955 P2530 HUMAN (Normal) ALBUMIN BP Alburel Reliance Life Sciences Pvt Injection 20% Restricted for R 29.08.2011 Registerd by State
Ltd,India Hospital use only Trading Organization
Plc.
956 P2515 HUMAN PAPLLOMAVIRUS VACCINE (HPV) Cervarix GlaxoSmithKline , Belgium Injection 0.5 ml (single dose) Contains POM R 23.06.2011 Registered By ADK
HPV 16..20µg, HPV 18..20 µg Company Pvt Ltd

957 P54 HYDROCORTISONE Hydrocortisone Ambalal Sarabhai Ophthalmic 1% POM R E Registered By ADK
India/Assence Pharma Pvt Ltd Solution Company Pvt Ltd

958 P1840 HYDROCORTISONE H-cort HOE Pharmaceutical Cream 1% w/w [acetate] in 15g POM R E
Manufacturing (M) Sdn. Bhd.,
Malaysia
959 P2606 HYDROCORTISONE Cortisone Hovid Bhd, Malaysia Cream 1% POM R 10.07.2012 Registered by GKT
Pharmacy
960 P1841 HYDROCORTISONE H-cort ointment HOE Pharmaceutical Topical Ointment 1% w/w [acetate] in 15g POM R E
Manufacturing (M) Sdn. Bhd.,
Malaysia

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 60 of 113 Authorized by:DG,MFDA
 961 P3948 HYDROCORTISONE Axcel Kotra Pharma (M) Sdn. Bhd., Cream 1% w/w (5g tube) POM Re 01.11.2016 - Market Exclusivity
Hydrocortisone 1, 2, & 3 Jalan TTC 12, Cheng 31.10.2021 given to State Trading
Industrial Estate, 75250 Organization Plc.
Melaka, Malaysia

962 P98 HYDROCORTISONE Astrocort cream Astron Limited, Sri Lanka Cream 0.5% 15g POM R E Registered By ADK
0.5% Company Pvt Ltd
963 P99 HYDROCORTISONE Astrocort cream1% Astron Limited, Sri Lanka Cream 1% 15g POM R E Registered By ADK
Company Pvt Ltd
964 P2269 HYDROCORTISONE Astrocort Astron Limited, Sri Lanka Ointment 1% 15g USP POM R E Registered By ADK
Ointment 1% Company Pvt Ltd
965 P1659 HYDROCORTISONE + CINCHOCAINE Proctosedyl Unlmark remedies India for Cream 10gm OTC R E Registered by ADK
HYDROCHLORIDE Aventis Pharma Company Pvt Ltd
966 P866 HYDROCORTISONE + MICONAZOLE Decocort HOE Pharmaceutical Cream 1% w/w + 2% w/w in 15g POM R Registered by Dial
Manufacturing (M) Sdn. Bhd., Trade and Travels Pte.
Malaysia Ltd.
967 P4351 HYDROGEN PEROXIDE Hydrogen Peroxide Xepa-Soul Pattinson Topical Solution 6% w/v (500ml) POM Re E 16.10.2018 - Market Exclusivity
(Malaysia) SDN. BHD. 1-5 15.10.2023 given to ADK
Cheng Industrial Estate, 75250 Pharmaceutical
Melaka, Malaysia Company Pvt. Ltd.
968 P2747 HYDROUS BENZOYL PEROXIDE Enzoxid 5 Gel Zyg Pharma, India Gel 5% POM R 08.05.2013 Registerd by State
Trading Organization
Plc.
969 P2748 HYDROUS BENZOYL PEROXIDE Enzoxid 2.5 Gel Zyg Pharma, India Gel 2.5% POM R 08.05.2013 Registerd by State
Trading Organization
Plc.
970 P1994 HYDROXIDE POLYMALTOSE COMPLEX Mumfer Oral liquid Glenmark , India Oral Liquid 50 mg in 5ml POM R E
EQUIVALENT TO ELEMENTAL IRON
971 P1995 Hydroxide Polymaltose Complex equivalent Mumfer Drops Glenmark , India Oral Drops 50 mg POM R E
to elemental Iron
972 P2872 HYDROXYCHLOROQUINE OXCQ Wallace Pharmaceuticals, Tablet 200 mg POM R 07.01.2014 Registered by AMDC
India Pvt Ltd
973 P2037 HYDROXYPROPYL METHYCELLULOSE USP Cool Eye Drops Ashford Laboratories Ltd Eye Drops 3.0mg OTC R

974 P2309 HYDROXYPROPYL METHYLCELLULOSE Genteal Excelvision France/Novartis Eye Drops 0.30% OTC R 02.02.2010 Registerd by State
Pharma Ag Switzerland Trading Organization
Plc.
975 P1790 HYDROXYPROPYL METHYLCELLULOSE Bion Tears Alcon Laboratories Inc Eye Drops 70 0.1% + 0.3% OTC R
Lubricating Eye
Drops
976 P1919 HYDROXYPROPYL METHYLCELLULOSE Eye Glow Moist Duopharma (M) Sdn. Bhd., Eye Drops 0.3% w/v OTC R
Malaysia
977 P3271 HYDROXYPROPYL METHYLCELLULOSE USP Hicel Remington Pharmaceuticals, Eye Drops 0.5% OTC R 06.01.2015 Registered by ADK
Pakistan Company Pvt Ltd

978 P2213 HYOSCINE BUTYLBROMIDE Hybro 10 Medopharm, India Tablet 10 mg POM R E Registered by Green
Pharmacy
979 P3753 HYOSCINE BUTYLBROMIDE Copan Duopharma (M) Injection 20 mg/ml POM Re 23.08.2016 - Market Exclusivity
Sdn.Bhd,Malaysia 22.08.2021 given to Dial Trade
and Travels Pte. Ltd.

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 61 of 113 Authorized by:DG,MFDA
 980 P3497 IBANDRONIC SODIUM Ibandron Aristo Pharma Limited, Tablet 150 mg POM Re 19.05.2015- Market Exclusivity
Bangladesh 18.05.2020 given to Life Support
Pvt. Ltd.
981 P271 IBUPROFEN Ibugesic Cipla India Oral Liquid 100 mg /5 ml OTC R E 17.12.2009 Registered by ADK
Company Pvt Ltd
982 P3132 IBUPROFEN Ibuprofen Cresent Pharma,London Tablet 200 mg OTC R E 08.07.2014 Registered by Life
Support Pvt Ltd
983 P3133 IBUPROFEN Ibuprofen Cresent Pharma,London Tablet 400 mg OTC R E 08.07.2014 Registered by Life
Support Pvt Ltd
984 P2174 IBUPROFEN Promed 400 mg Medopharm, India Tablet 400 mg OTC R
985 P3938 IBUPROFEN Axcel Ibuprofen Kotra Pharma (M) Sdn. Bhd., Paediatric Syrup 100 mg per 5ml (60ml bottle) POM Re 01.11.2016 - Market Exclusivity
1, 2, & 3 Jalan TTC 12, Cheng 31.10.2021 given to State Trading
Industrial Estate, 75250 Organization Plc.
Melaka, Malaysia

986 P2501 IBUPROFEN BP Arfen Arvind Remedies Ltd, India Tablet 200 mg OTC R 23.02.2011 Registered by Green
Pharmacy
987 P3158 IBUPROFEN IP Brufen 200 Abbott India Tablet 200 mg OTC R E 19.08.2014 Registered by Life
Support Pvt Ltd
988 P3157 IBUPROFEN IP Brufen 400 Abbott India Tablet 400 mg OTC R E 19.08.2014 Registered by Life
Support Pvt Ltd
989 P973 IBUPROFEN IP Brufen Abbott India Tablet 600 mg OTC R E 20.05.2014 Registered by Life
Support Pvt Ltd
990 P3677 IMATINIB MESYLATE Glivec Novartis Pharma Stein AG, Capsule 100 mg POM Re 23.02.2016 - Market Exclusivity
Stein, Switzerland 22.02.2021 given to Mediquip
Maldives Pvt. Ltd.
991 P3538 INDACATEROL MALEATE Onbrez Breezhaler Novartis Pharma Stein AG, Inhalation Capsule 150 mcg POM Re 30.06.2015 - Market Exclusivity
Stein, Switzerland 29.06.2020 given to Mediquip
Maldives Pvt. Ltd.
992 P3539 INDACATEROL MALEATE Onbrez Breezhaler Novartis Pharma Stein AG, Inhalation Capsule 300 mcg POM Re 30.06.2015 - Market Exclusivity
Stein, Switzerland 29.06.2020 given to Mediquip
Maldives Pvt. Ltd.
993 P2046 INDOMETHACIN Emcid Medopharm, India Capsule 25 mg POM R Registered by Green
Pharmacy
994 P3731 INSULIN ASPART NovoRapid Novo Nordisk A/S , Denmark Pre-filled injection 100U(3.5mg)/ml (3ml) POM Re 24.05.2016 - Market Exclusivity
FlexPen (Pre-filled pen) 23.05.2021 given to ADK
Pharmaceutical
Company Pvt. Ltd.
995 P3732 INSULIN DETERMIR Levemir FlexPen Novo Nordisk A/S , Denmark Pre-filled injection 100U(14.2mg)/ml (3ml) POM Re 24.05.2016 - Market Exclusivity
(Pre-filled pen) 23.05.2021 given to ADK
Pharmaceutical
Company Pvt. Ltd.
996 P3764 INSULIN GLARGINE Lantus Sanofi - Aventis Deutschland Solution for 100 IU/ml POM Re 06.09.2016 - Market Exclusivity
GmbH, Germany injection in 05.09.2021 given to State Trading
Catriage Organization Plc.

997 P1056 INSULIN HUMAN Humulin(70/30) Lilly France Injection 100iu/ml POM R E
998 P1057 INSULIN HUMAN Humulin(NPH) Lilly France Injection 100iu/ml POM R E
999 P1058 INSULIN HUMAN Humulin(R) Lilly France Injection 100iu/ml POM R E

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 62 of 113 Authorized by:DG,MFDA
 1000 P3765 INSULIN HUMAN 25% Insuman Comb 25 Sanofi - Aventis Deutschland Suspension for 100 IU/ml POM Re 06.09.2016 - Market Exclusivity
dissolvedinsulin +75% crystalline protamine GmbH, Germany injection in 05.09.2021 given to State Trading
insulin cartriage Organization Plc.

1001 P3730 INSULIN HUMAN (rDNA) Insulatard Novo Nordisk A/S , Denmark Injection 100IU(3.5mg)/ml (10ml) POM Re 24.05.2016 - Market Exclusivity
23.05.2021 given to ADK
Pharmaceutical
Company Pvt. Ltd.
1002 P3733 INSULIN HUMAN (rDNA) Insulatard Penfill Novo Nordisk A/S , Denmark Penfill Cartridge 100IU(3.5mg)/ml (3ml) POM Re 24.05.2016 - Market Exclusivity
23.05.2021 given to ADK
Pharmaceutical
Company Pvt. Ltd.
1003 P3718 INSULIN HUMAN(rDNA) Actrapid Novo Nordisk A/S , Denmark Injection 100IU(3.5mg)/ml (10ml) POM Re 17.05.2016 - Market Exclusivity
16.05.2021 given to ADK
Pharmaceutical
Company Pvt. Ltd.
1004 P3720 INSULIN HUMAN(rDNA) Actrapid Penfill Novo Nordisk A/S , Denmark Penfill Cartridge 100IU(3.5mg)/ml (3ml) POM Re 17.05.2016 - Market Exclusivity
16.05.2021 given to ADK
Pharmaceutical
Company Pvt. Ltd.
1005 P3719 INSULIN HUMAN(rDNA) SOLUBLE INSULIN MIXTARD Novo Nordisk A/S , Denmark Injection 100IU(3.5mg)/ml (30%+70%) POM Re 17.05.2016 - Market Exclusivity
+ ISOPHANE INSULIN (10ml) 16.05.2021 given to ADK
Pharmaceutical
Company Pvt. Ltd.
1006 P3721 INSULIN HUMAN(rDNA) SOLUBLE INSULIN + Mixtard Penfill Novo Nordisk A/S , Denmark Penfill Cartridge 100IU(3.5mg)/ml (30%+70%) POM Re 17.05.2016 - Market Exclusivity
ISOPHANE INSULIN (3ml) 16.05.2021 given to ADK
Pharmaceutical
Company Pvt. Ltd.
1007 P1059 INSULIN LISPRO Humalog Lilly France Injection 100iu/ml POM R E
1008 P1483 INTERFERON ALPHA 2a Roferon-A Roche, Switzerland Injection 3MIU/0.5ml POM R
1009 P1485 INTERFERON ALPHA 2a Roferon-A Roche, Switzerland Injection 4.5MIU/0.5ml POM R
1010 P1484 INTERFERON ALPHA 2a Roferon-A Roche, Switzerland Injection 3MIU/1ml POM R
1011 P1486 INTERFERON ALPHA 2a Roferon-A Roche, Switzerland Injection 4.5MIU/1ml vials POM R
1012 P1487 INTERFERON ALPHA 2a PEGYLATED Pegysis-135 Roche, Switzerland Injection 135mcg/vial POM R
1013 P1488 INTERFERON ALPHA 2a PEGYLATED Pegysis-180 Roche, Switzerland Injection 180mcg/vial POM R
1014 P273 IPRATROPIUM BROMIDE Ipravent Cipla India Aerosol 20mcg/puff 200 MD POM R E 17.12.2009 Registered by ADK
Company Pvt Ltd
1015 P224 IPRATROPIUM BROMIDE Atem Spray Chiesi Farmaceutici SPA Italy Inhaler 4 mg/metered dose POM R

1016 P3734 IPRATROPIUM BROMIDE Ipravent Cipla Ltd India DP Capsule 40mcg POM R 24.05.2016 Registered
(Powder for
inhalation)
1017 P1906 IRON CHOLINE CITRATE + FOLIC ACID IP + Folenic 12 Sterling Lab, India Oral Liquid 200mg + 1.5mg + 50mg in 5ml POM R Registered by AMDC
LYSIN USP Pvt Ltd
1018 P2788 IRON PROTEIN SUCCINATE Iropal Oral liquid Pharmix Laboratorie, Pakistan Oral Liquid 800mg/15 ml POM R 05.06.2013 Registered by Life
Support Pvt Ltd
1019 P1524 ISOCONAZOLE Gyno Travogen Schering AG, Germany Ovule 600 mg POM R
1020 P1525 ISOCONAZOLE Travogen Schering AG, Germany Cream 1% in 20g POM R
1021 P1527 ISOCONAZOLE + DIFLUCORTLONE Travacort Schering AG, Germany Cream 10mg, + 1mg per g in 15g POM R

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 63 of 113 Authorized by:DG,MFDA
 1022 P824 ITRACONAZOLE Canditral Glenmark , India Capsule 100mg POM R Registered by ADK
Company Pvt Ltd
1023 P3566 ITRACONAZOLE Inox Hovid Bhd. 121, Jalan Tunku Capsule 100 mg POM Re 08.09.2015 - Market Exclusivity
Abdul Rahman, 30010 Ipoh, 07.09.2020 given to My Chemist
Malaysia Wholesale
1024 P2230 ITRACONAZOLE BP Itracon 100 Micro Labs ltd Capsule 100 mg POM R Registered by ADK
Company Pvt Ltd
1025 P963 KETOCONAZOLE Mycoral Kalbe Farma, Indonesia Cream 2% OTC R E
1026 P964 KETOCONAZOLE Mycoral Kalbe Farma, Indonesia Topical Solution 2% OTC R E

1027 P4356 KETOCONAZOLE Pristinex Xepa-Soul Pattinson Cream 2% w/w (15g) POM Re E 16.10.2018 - Market Exclusivity
(Malaysia) SDN. BHD. 1-5 15.10.2023 given to ADK
Cheng Industrial Estate, 75250 Pharmaceutical
Melaka, Malaysia Company Pvt. Ltd.
1028 P862 KETOCONAZOLE Dezor 60ml HOE Pharmaceutical Medicated 2%w/v in 60ml OTC R E Registered by Dial
Manufacturing (M) Sdn. Bhd., Shampoo Trade and Travels Pte.
Malaysia Ltd.
1029 P863 KETOCONAZOLE Dezor 120ml HOE Pharmaceutical Medicated 2%w/v in 120ml OTC R E Registered by Dial
Manufacturing (M) Sdn. Bhd., Shampoo Trade and Travels Pte.
Malaysia Ltd.
1030 P3170 KETOCONAZOLE Ketoplus Glenmark , India Medicated 2% w/v OTC R 16.09.2014 Registered by ADK
Shampoo Company Pvt Ltd
1031 P2861 KETOCONAZOLE Ketovid Cream Hovid Bhd, Malaysia Cream 2% OTC R 07.11.2013 Registered by GKT
Pharmacy
1032 P3171 KETOCONAZOLE Ketovid Hovid Bhd, Malaysia Medicated 2% OTC R 16.09.2014 Registered by GKT
Shampoo Pharmacy
1033 P2662 KETOCONAZOLE Ketoconazole Hovid Bhd, Malaysia Tablet 200 mg POM R 27.11.2012 Registered by GKT
Pharmacy
1034 P861 KETOCONAZOLE Dezor HOE Pharmaceutical Cream 2%w/w in 15g OTC R E Registered by Dial
Manufacturing (M) Sdn. Bhd., Trade and Travels Pte.
Malaysia Ltd.
1035 P3736 KETOCONAZOLE Ketozotan Duopharma (M) Sdn.Bhd, Tablet 200mg POM Re 24.05.2016 - Market Exclusivity
Malaysia 23.05.2021 given to Dial Trade
and Travels Pte. Ltd.
1036 P3106 KETOPROFEN Ketofen Hovid Bhd. 121, Jalan Tunku Gel 2.5% w/w POM R 20.05.2014 Registered by GKT
Abdul Rahman, 30010 Ipoh, Pharmacy
Malaysia
1037 P2010 KETOPROFEN Kop Injection Square Pharmaceuticals, Injection 100 mg/2 ml POM R
Bangladesh
1038 P2011 KETOPROFEN Kop Tablets Square Pharmaceuticals, Tablet 100 mg POM R
Bangladesh
1039 P4470 KETOTIFEN (as HYDROGEN FUMERATE) Asmafen Xepa-Soul Pattinson Syrup (Peach 1mg/5ml (120ml) POM Re E 09.04.2019 - Market Exclusivity
(Malaysia) SDN. BHD. 1-5 Flavour) 08.04.2024 given to ADK
Cheng Industrial Estate, 75250 Pharmaceuticals
Melaka, Malaysia Company Pvt. Ltd.
1040 P3565 KETOTIFEN FUMARATE Ketotifen Hovid Bhd. 121, Jalan Tunku Oral Liquid 1 mg/5 ml POM Re 08.09.2015 - Market Exclusivity
Abdul Rahman, 30010 Ipoh, 07.09.2020 given to My Chemist
Malaysia Wholesale

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 64 of 113 Authorized by:DG,MFDA
 1041 P3466 KETOTIFEN FUMARATE Antifen Pharmix Laboratories (Pvt) Oral Liquid 0.2mg/ml POM Re 21.04.2015 - Market Exclusivity
Ltd. 21-Km, Ferozepur Road 20.04.2020 given to Life Support
Lahore - 54760 - Pvt. Ltd.
Pakistan

1042 P4282 KETOTIFEN HYDROGEN FUMARATE Astifen PT. Farma Tbk. Kawasan Syrup 1mg/5ml (60ml) POM Re 17.04.2018 - Market Exclusivity
Industri Delta Silicon JI. M.H 16.04.2023 given to State Trading
Thamrin Block A3-1 Lippo Organization Plc.
Cikarang Bekasi - Indonesia
(for PT. Hexpharm Jaya Bekasi
- Indonesia)

1043 P2689 LACTITOL MONOHYDRATE USP Eva Q Oral liquid Medley Ltd, India. Oral Liquid 10 gm in 15ml POM R 28.01.2013 Registered by ADK
Company Pvt Ltd
1044 P2647 LACTULOSE Ecolac Solution Sterling Lab, India. Solution 3.34 g OTC R 02.10.2012 Registered by AMDC
Pvt Ltd
1045 P2488 LACTULOSE USP Feccox MMC Health Care Ltd,India Oral Liquid 10.05g in 15ml OTC R 23.02.2011 Registered by Green
Pharmacy
1046 P3203 LACTULOSE USP Osmolax Square Pharmaceuticals, Oral Liquid 3.40 gm in 5ml OTC R 06.11.2014 Registered by Dial
Bangladesh Trade and Travels Pte.
Ltd.
1047 P441 LACTULOSE USP Duphalac Abbott India Limited, L-18, Oral Liquid 3.335g/5ml OTC Re E 01.08.2017 - Market Exclusivity
Verna Industrial Estate. Verna 01.08.2022 given to ADK
Salcette, Goa 403722, INDIA Pharmaceutical
Company Pvt. Ltd.
1048 P2521 LANSOPRAZOLE Selanz SR Searle, Pakistan Capsule 30 mg POM R 23.06.2011 Registered by ADK
Company Pvt Ltd
1049 P2227 LANSOPRAZOLE Milan 30 Micro Labs ltd Capsule 30 mg POM R Registered by ADK
Company Pvt Ltd
1050 P1907 LANSOPRAZOLE Lansol Sterling Lab, India Capsule 30mg POM R Registered by AMDC
Pvt Ltd
1051 P1892 LANSOPRAZOLE Lanso 30 Square Pharmaceuticals, Tablet 30 mg POM R
Bangladesh
1052 P2266 LANSOPRAZOLE IP Chexid Aristo India Capsule 30mg POM R Registered by ADK
Company Pvt Ltd

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 65 of 113 Authorized by:DG,MFDA
 1053 P2478 L-Arginine Hydrochloride + L-Histidine AMINOPLEX FORTE MMC Health Care Ltd,India Oral Liquid 13.28 mg + 3.71mg + 5.9 mg OTC R 23.02.2011 Registered by Green
Hydrochloride monohydrate + L-Isoleucine + 18.3 mg + 25 mg + 9.2mg Pharmacy
+ L-Leucine + L-Lysine Hydrochloride + L- + 5 mg + 4.2 mg + 5 mg + 6.7
Methionine + L-Phenylalanine + L- mg + A 2500 IU + 10 IU + 200
Threonine + L-Tryptophan + L-Valine + IU + 1.5 mg + 1.7 mg + 1.5 mg
Vitamin A + Vitamin E + Vitamin D3 ( + 1 mcg + 20 mg + 5mg +
Cholecalciferol) + Thiamine Hydrochloride + 0.75mg + 30 mcg + 5mg
Riboflavine (as Riboflavin ) Sodium
Phosphate + Pyridoxine Hydrochloride +
Cyanocobalamin + Nicotinamide + Calcium
Pantothenate + Folic Acid + Biotin +
Elemental Zinc (as Zinc Sulphate
Monohydrate)

1054 P3471 LEFLUNOMIDE Lefodil Pharmix Laboratories Pakistan Tablet 25 mg POM Re 21.04.2015 - Market Exclusivity
20.04.2020 given to Life Support
Pvt. Ltd.
1055 P3473 LEFLUNOMIDE Lefodil Pharmix Laboratories Pakistan Tablet 20 mg POM Re 21.04.2015 - Market Exclusivity
20.04.2020 given to Life Support
Pvt. Ltd.
1056 P3673 LETROZOLE Femara Novartis Pharma Stein AG, Film Coated Tablet 2.5 mg POM Re 23.02.2016 - Market Exclusivity
Stein Switzerland 22.02.2021 given to Mediquip
Maldives Pvt. Ltd.
1057 P4466 LETROZOLE USP Lentronat Natco Pharma Limited Kothur- Tablet 2.5mg POM Re 09.04.2019 - Market Exclusivity
509 228, Rangareddy District 08.04.2024 given to ADK
Telangana, India Pharmaceuticals
Company Pvt. Ltd.
1058 P3681 LEVETIRACETAM Klevra PharmEvo (Private) Limited, Film Coated Tablet 250 mg POM Re E 01.03.2016- Market Exclusivity
At Plot # A-29, Northe 28.02.2021 given to Life Support
Western Industrial Zone, Port Pvt. Ltd.
Qasim, Karachi, Karachi-
75020, Pakistan

1059 P2428 LEVOCETIRIZINE Hatric Aristo India Tablet 5 mg OTC R 25.10.2010 Registered by ADK
Company Pvt Ltd
1060 P2128 LEVOCETIRIZINE Fitin 5 Medley Ltd, India. Tablet 5 mg OTC R
1061 P3461 LEVOCETIRIZINE Seasonix Incepta pharmaceuticals Tablet 5 mg POM Re 24.03.2015 - Market Exclusivity
Limited, Bangladesh 23.03.2020 given to Dial Trade
and Travels Pte. Ltd.
1062 P3628 LEVOCETIRIZINE Xyzal Exemed Pharmaceuticals, Tablet 5 mg OTC Re 17.11.2015- Market Exclusivity
India 16.11.2020 given to Life Support
Pvt. Ltd.
1063 P3987 LEVOCETIRIZINE HYDROCHLORIDE Swicet L Swiss Garnier Life Sciences, Film-coated tablet 5mg POM Re 20.06.2017 - Market Exclusivity
No:21-23 Industrial Area, 20.06.2022 given to AMDC Pvt.
Mehatpur, Dist UNA, Ltd.
Himachel Pradesh, 174315,
INDIA

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 66 of 113 Authorized by:DG,MFDA
 1064 P2806 LEVOCETIRIZINE IP Glencet Glenmark , India Tablet 5 mg OTC R 26.08.2013 Registered by ADK
Company Pvt Ltd
1065 P2715 LEVODOPA + CARBIDOPA BP Tidomet Forte Torrent Pharmaceuticals, Tablet 250 mg+ 25mg POM R 19.02.2013 Registered by Life
India Support Pvt Ltd
1066 P3211 LEVOFLOXACIN Lefovid Hovid Bhd, Malaysia Tablet 500 mg POM R 06.11.2014 Registered by GKT
Pharmacy
1067 P2434 LEVOFLOXACIN Glevo IV Glenmark , India Injection 500mg/100 ml POM R 26.10.2010 Registered by ADK
Each Company Pvt Ltd
Shipment
should be
accompanied
by the batch
certificates

1068 P800 LEVOFLOXACIN Glevo Glenmark , India Tablet 250mg POM R Registered by ADK
Company Pvt Ltd
1069 P2255 LEVOFLOXACIN Levoxin 500 Incepta pharmaceuticals Tablet 500 mg POM R Registered by Dial
Limited, Bangladesh Trade and Travels Pte.
Ltd.
1070 P2532 LEVOFLOXACIN Levogen General Pharmacueticals Tablet 250mg POM R 29.08.2011 Registered by Dial
Ltd,Bangladesh Trade and Travels Pte.
Ltd.
1071 P2533 LEVOFLOXACIN Levogen General Pharmacueticals Tablet 500mg POM R 29.08.2011 Registered by Dial
Ltd,Bangladesh Trade and Travels Pte.
Ltd.
1072 P2403 LEVOFLOXACIN Lev Q 250 Medopharm, India Tablet 250 mg POM R 30.09.2010 Registered by Green
Pharmacy
1073 P2404 LEVOFLOXACIN Lev Q 500 Medopharm, India Tablet 500 mg POM R 30.09.2010 Registered by Green
Pharmacy
1074 P2250 LEVOFLOXACIN Levobact 500 Micro Labs ltd Tablet 500 mg POM R Registered by ADK
Company Pvt Ltd
1075 P2251 LEVOFLOXACIN Levobact 250 Micro Labs ltd Tablet 250 mg POM R Registered by ADK
Company Pvt Ltd
1076 P1830 LEVOFLOXACIN Glevo Glenmark , India Tablet 500mg POM R
1077 P3656 LEVOFLOXACIN Levocil 250 CCL Pharmaceuticals, Tablet 250 mg POM Re 21.01.2016 - Market Exclusivity
Pakistan 20.01.2021 given to State Trading
Organization Plc.

1078 P3662 LEVOFLOXACIN Levocil 500 CCL Pharmaceuticals, Film Coated Tablet 500 mg POM Re 21.01.2016 - Market Exclusivity
Pakistan 20.01.2021 given to State Trading
Organization Plc.

1079 P3516 LEVOFLOXACIN Atoflox -500 Atoz Pharmaceuticals, India Tablet 500 mg POM Re 19.05.2015- Market Exclusivity
18.05.2020 given to My Chemist
Wholesale
1080 P3455 LEVOFLOXACIN USP Levoxin 250 Incepta pharmaceuticals Tablet 250 mg POM Re E 24.03.2015 - Market Exclusivity
Limited, Bangladesh 23.03.2020 given to Dial Trade
and Travels Pte. Ltd.
1081 P2789 LEVOSULPRIDE Eleral Pharmix Laboratorie, Pakistan Tablet 50 mg POM R 05.06.2013 Registered by Life
Support Pvt Ltd

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 67 of 113 Authorized by:DG,MFDA
 1082 P2628 LEVOTHYROXINE SODIUM T4 Montpellier Quimica Montpellier, Tablet 100 mcg POM R 18.09.2012 Registered by ADK
Argentina Company pvt Ltd
1083 P2261 LIGNOCAINE Anasica Jelly Ambalal Sarabhai Gel 2% POM R Registered by ADK
India/Assence Pharma Pvt Ltd Company Pvt Ltd

1084 P4067 LIGNOCAINE HYDROCHLORIDE Axcel Lignocaine Kotra Pharma (M) Sdn. Bhd., Sterile Gel 2.0% w/w (20gm) POM Re 03.10.2017 - Market Exclusivity
2% sterile gel 1, 2 & 3 Jalan TTC 12, Cheng 02.10.2022 given to State Trading
Industrial Estate, 75250 Organization Plc.
Melaka, Malaysia

1085 P4223 LIGNOCAINE HYDROCHLORIDE Vaxcel Ligocaine Kotra Pharma (M) Sdn. Bhd., Injection (Sterile 1% 50mg/5ml Restricted for Re 13.03.2018 - Market Exclusivity
1% 1,2 & 3 Jalan TTC 12, Cheng Solution) Hospital / 12.03.2023 given to State Trading
Industrial Estate, 75250 Institutional Use Organization Plc.
Melaka, Malaysia Only
1086 P4292 LIGNOCAINE HYDROCHLORIDE Vaxcel Lignocaine Kotra Pharma (M) Sdn. Bhd., Injection 2% (200mg/10ml) Restricted for Re 17.04.2018 - Market Exclusivity
2% 1, 2 & 3 Jalan TTC 12, Cheng Hospital / 16.04.2023 given to State Trading
Industrial Estate, 75250 Institutional Use Organization Plc.
Melaka, Malaysia Only

1087 P2115 LIGNOCAINE USP + POLYMYXIN B USP Otocaine Ear Drops Ashford Laboratories Ltd Ear Drops 56 mg + 10,000 Units POM R

1088 P2028 LINEZOLID Lizolid 600 Glenmark , India Tablet 600 mg Restricted for R
Hospital use only

1089 P2433 LINEZOLID + DEXTROSE MONOHYDRATE Lizolid Glenmark Pharmaceuticals Injection 200mg + 5% w/v per 100 ml POM R 26.10.2010 Registered by ADK
USP (Dextrose Anhydrous) Ltd. INDIA Company pvt Ltd

1090 P978 LIQUID PARAFFIN IP + MILK OF MAGNESIA Cremaffin Abbott India Oral Liquid 3.75 ml + 11.25 ml in 5ml OTC R 08.07.2014 Registered by Life
IP Support Pvt Ltd
1091 P2738 LISINOPRIL BP Listril 5 Torrent Pharmaceuticals, Tablet 5 mg POM R 08.05.2013 Registered by Life
India Support Pvt Ltd
1092 P2023 LODOXAMIDE Alomide Alcon,Belgium Ophthalmic 0.10% POM R
Solution
1093 P481 LOPERAMIDE Emod Efroze Pakistan Capsule 2 mg POM R E Registered by Green
Pharmacy
1094 P2610 LOPERAMIDE Colodium Hovid Bhd, Malaysia Capsule 2 mg POM R E 10.07.2012 Registered by GKT
Pharmacy
1095 P3568 LOPERAMIDE IP Imodium J&J, India Capsule 2 mg POM Re 08.09.2015 - Market Exclusivity
07.09.2020 given to Mediquip
Maldives Pvt. Ltd.
1096 P1908 LOPERAMIDE USP Dialamid Sterling Lab, India Capsule 2mg POM R Registered by AMDC
Pvt Ltd
1097 P2289 LORATADINE Allerban Saga Laboratories, India Tablet 10 mg OTC R E Registered by Dial
Trade and Travels Pte.
Ltd.
1098 P1993 LORATADINE Lorahist Medopharm, India Tablet 10 mg OTC R E Registered by Green
Pharmacy
1099 P1813 LORATADINE Loratin Cipla India Tablet 10 mg OTC R E 05.05.2009 Registered by ADK
Company pvt Ltd

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 68 of 113 Authorized by:DG,MFDA
 1100 P1909 LORATADINE Lorax Sterling Lab, India Tablet 10mg OTC R Registered by AMDC
Pvt Ltd
1101 P2799 LORATADINE Loradine Y.S.P Inductries , Malaysia Tablet 10 mg OTC R 26.08.2013 Registered by Dial
Trade and Travels Pte.
Ltd.
1102 P2800 LORATADINE Loradine Y.S.P Inductries , Malaysia Oral Liquid 1mg/ml OTC R 26.08.2013 Registered by Dial
Trade and Travels Pte.
Ltd.
1103 P2609 LORATADINE Loratyn Hovid Bhd, Malaysia Tablet 10 mg OTC R 10.07.2012 Registered by GKT
Pharmacy
1104 P3749 LORATADINE Axcel Loratadine Kotra Pharma, Malaysia Tablet 10 mg OTC Re 30.08.2016 - Market Exclusivity
29.08.2021 given to State Trading
Organization Plc.

1105 P4352 LORATADINE Ezede' Xepa-Soul Pattinson Tablet 10mg OTC Re E 16.10.2018 - Market Exclusivity
(Malaysia) SDN. BHD. 1-5 15.10.2023 given to ADK
Cheng Industrial Estate, 75250 Pharmaceutical
Melaka, Malaysia Company Pvt. Ltd.
1106 P3590 LORATADINE USP Allerdin MMC Healthcare Ltd. India Oral Liquid 5 mg/5 ml POM Re 27.10.2015- Market Exclusivity
26.10.2020 given to Green
Pharmacy Godown
1107 P2674 LORAZEPAM Loracalm East West Pharma,India Tablet 1 mg INTERNATIONALLY R 22.01.2013 Registerd by State
CONTROLLED Trading Organization
(PSYCHOTROPIC) Plc.
1108 P2675 LORAZEPAM Loracalm East West Pharma,India Tablet 2 mg INTERNATIONALLY R 22.01.2013 Registerd by State
CONTROLLED Trading Organization
(PSYCHOTROPIC) Plc.
1109 P3608 L-ORNITHINE-L-ASPARTATE Levanor Micro Labs Limited, 67/68A, Granules (in 3g in 5g sachet POM R 25.05.2015 Registered
3rd Phase, Peenya, Bangalore- Sachets)
560 058, India

1110 P3600 LOSARTAN POTASSIUM BP Losa 50 Aeon Formulations Pvt. Ltd., Film Coated Tablet 50 mg POM Re 20.10.2015 - Market Exclusivity
India 19.10.2020 given to Moonima
Medicals
1111 P2201 LOSARTAN POTASSIUM Angizaar 50 Micro Labs ltd Tablet 50 mg POM R E Registered by ADK
Company pvt Ltd
1112 P2394 LOSARTAN POTASSIUM Osartil 25 Incepta pharmaceuticals Tablet 25 mg POM R 02.09.2010 Registered by Dial
Limited, Bangladesh Trade and Travels Pte.
Ltd.
1113 P2411 LOSARTAN POTASSIUM Alsartan 50 Aristo India Tablet 50 mg POM R 07.10.2010 Registered by ADK
Company pvt Ltd
1114 P2215 LOSARTAN POTASSIUM Lostar 50 Medopharm, India Tablet 50 mg POM R E Registered by Green
Pharmacy
1115 P1654 LOSARTAN POTASSIUM Myotan Unique, India Tablet 25mg POM R Registered by ADK
Company pvt Ltd
1116 P1655 LOSARTAN POTASSIUM Myotan Unique, India Tablet 50mg POM R Registered by ADK
Company pvt Ltd
1117 P2773 LOSARTAN POTASSIUM Lorpam 25 Atoz Pharmaceuticals ,India Tablet 25 mg POM R 05.06.2013 Registered by My
Chemist Wholesale

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 69 of 113 Authorized by:DG,MFDA
 1118 P1936 LOSARTAN POTASSIUM Vazortan 25 Medley Ltd, India. Tablet 25 mg POM R E
1119 P2774 LOSARTAN POTASSIUM + Lorpam H Tablet Atoz Pharmaceuticals ,India Tablet 50mg + 12.5 mg POM R 05.06.2013 Registered by My
HYDROCHLOROTHIAZIDE Chemist Wholesale

1120 P2703 LOSARTAN POTASSIUM + Tozaar H Torrent Pharmaceuticals, Tablet 50 mg + 12.5 mg POM R 19.02.2013 Registered by Life
HYDROCHLOROTHIAZIDE BP India Support Pvt Ltd
1121 P2202 LOSARTAN POTASSIUM + Angizaar H Micro Labs ltd Tablet 50mg +12.5mg POM R Registered by ADK
HYDROCHLOROTHIAZIDE USP Company pvt Ltd
1122 P2701 LOSARTAN POTASSIUM BP Tozaar Torrent Pharmaceuticals, Tablet 25mg POM R E 19.02.2013 Registered by Life
India Support Pvt Ltd
1123 P2702 LOSARTAN POTASSIUM BP Tozaar Torrent Pharmaceuticals, Tablet 50mg POM R E 19.02.2013 Registered by Life
India Support Pvt Ltd
1124 P2815 LOSARTAN POTASSIUM USP Emtan 25 MMC Health Care Ltd,India Tablet 25 mg POM R 26.08.2013 Registered by Green
Pharmacy
1125 P2816 LOSARTAN POTASSIUM USP Emtan 50 MMC Health Care Ltd,India Tablet 50 mg POM R 26.08.2013 Registered by Green
Pharmacy
1126 P2200 LOSARTAN POTASSIUM USP Angizaar 25 Micro Labs ltd Tablet 25 mg POM R E Registered by ADK
Company pvt Ltd
1127 P1935 LOSARTAN POTASSIUM USP Vazortan 50 Medley Ltd, India. Tablet 50 mg POM R E 23.05.2010 Registered by ADK
Company pvt Ltd
1128 P2772 LOSARTAN POTASSIUM USP Lorpam 50 Atoz Pharmaceuticals ,India Tablet 50 mg POM R 05.06.2013 Registered by My
Chemist Wholesale

1129 P3459 LOSARTAN POTASSIUM USP Osartil 50 Incepta pharmaceuticals Tablet 50mg POM Re E 24.03.2015 - Market Exclusivity
Limited, Bangladesh 23.03.2020 given to Dial Trade
and Travels Pte. Ltd.
1130 P3745 LOSARTAN POTASSIUM USP Resilo 50 Dr.Reddy's Laboratories Tablet 50 mg POM Re 30.08.2016 - Market Exclusivity
Ltd.,India 29.08.2021 given to State Trading
Organization Plc.

1131 P3746 LOSARTAN POTASSIUM USP Resilo 25 Dr.Reddy's Laboratories Tablet 25mg POM Re 30.08.2016 - Market Exclusivity
Ltd.,India 29.08.2021 given to State Trading
Organization Plc.

1132 P3460 LOSARTAN POTASSIUM USP + Osartil 50 Plus Incepta pharmaceuticals Tablet 50 mg + 12.5 mg POM Re 24.03.2015 - Market Exclusivity
HYDROCHLOROTHIAZIDE BP Limited, Bangladesh 23.03.2020 given to Dial Trade
and Travels Pte. Ltd.
1133 P2352 LOSARTAN POTASSIUM USP + Vazortan- H Medley Ltd, India. Tablet 50mg + 12.5mg POM R Registered by ADK
HYDROCHLOROTHIAZIDE USP Company pvt Ltd
1134 P34 LOVASTATIN Lovameg Alembic Pharmaceuticals Tablet 20mg POM R Registered by Dial
Limited India Trade and Travels Pte.
Ltd.
1135 P2798 LOVASTATIN Lovastin Y.S.P Inductries , Malaysia Tablet 20 mg POM R 26.08.2013 Registered by Dial
Trade and Travels Pte.
Ltd.
1136 P2734 MAGNESIUM + CALCIUM + VITAMIN D3 Sunlife Calcium + Sunlife Laboratories, Germany sachet (Stick) 300mg+600 mg + 5μg OTC R 16.04.2013 Registered by ADK
Magnesium +D3 Company Pvt Ltd
Sticks

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 70 of 113 Authorized by:DG,MFDA
 1137 P2731 MAGNESIUM CARBONATE Sunlife Magnesium Sunlife Laboratories, Germany Tablet 200mg POM R 16.04.2013 Registered by ADK
Carbonate Company Pvt Ltd

1138 P4172 MAGNESIUM CARBONATE Magesium Sunlife Productions, Australia Effervescent 200 mg OTC Re 30.06.2015- Market Exclusivity
Tablet 29.06.2020 given to ADK Company
Pvt. Ltd.
1139 P3257 MAGNESIUM HYDROXIDE + SIMETHICONE + Digecaine Akums Drugs and Oral Liquid 600 mg(IP) + 25 mg(IP) + 10 OTC R 06.01.2015 Registered by Life
OXETACAINE Pharmaceuticals, India mg(BP) in 5ml Support Pvt Ltd
1140 P4075 MAGNESIUM HYDROXIDE I.P + Digene gel (Mint Abbott India Limited L18 Oral Liquid 185mg+50mg+100mg+830mg OTC Re E 03.10.2017 - Market Exclusivity
SIMETHICONE I.P + SODIUM Flavour) Verna Industrial Area, Verna, in 10ml 02.10.2022 given to ADK
CARBOXYMETHYLCELLULOSE I.P + DRIED Salcetta Goa-403722, India Pharmaceutical
ALUMINIUM HYDROXIDE I.P Company Pvt. Ltd.
1141 P3111 MAGNESIUM TRISILICATE MIXTURE Mixture Hovid Bhd, Malaysia Oral Liquid 3.33%w/v + 3.33%w/v + 3.33% POM R 20.05.2014 Registered by GKT
+MAGNESIUM CARBONATE+SODIUM Magnesium w/v in 5ml Pharmacy
BICARBONATE Trisilicate
1142 P864 MALATHION A - Lices Scalp and HOE Pharmaceutical Topical Liquid 1% in 30ml W/V OTC R Registered by Dial
Body Hygiene Manufacturing (M) Sdn. Bhd., Trade and Travels Pte.
Shampoo Malaysia Ltd.

1143 P118 MANNITOL MANNITOL Fresenius Kabi, India Injection 20% POM R E Each
Shipment
should be
accompanied
by the batch
certificates

1144 P276 MEBENDAZOLE Mebex Cipla India Tablet 100 mg OTC R E 03.02.2010 Registered by ADK
Company Pvt Ltd
1145 P277 MEBENDAZOLE Mebex Cipla India Oral Liquid 100 mg/ 5 ml OTC R E 03.02.2010 Registered by ADK
Company Pvt Ltd
1146 P2050 MEBENDAZOLE Meboz Medopharm, India Tablet 100 mg OTC R Registered by Green
Pharmacy
1147 P1149 MEBENDAZOLE Helmintol Medley Ltd, India. Tablet 100 mg OTC R E Registered by ADK
Company Pvt Ltd
1148 P3614 MEBEVERINE HYDROCHLORIDE BP Mevir-135 Micro Labs Limited, 92, Film Coated Tablet 135 mg POM Re 25.05.2015- Market Exclusivity
SIPCOT, HOSUR-635 126 INDIA 24.05.2020 given to ADK Company
Pvt. Ltd.
1149 P3592 MECOBALAMIN + ALPHA LIPOIC ACID + Neurogen MMC Health Care Ltd., No. 34- Hard gelatin 300mcg JP + 100mg USP+ 5mg POM Re 27.10.2015- Market Exclusivity
THIAMINE NITRATE + RIBOFLAVIN + B, SIDCO Industrial Estate, Capsule BP+2.1mg BP + 1.5mg BP+ 26.10.2020 given to Green
PYRIDOXINE HCL + NICOTINAMIDE + Thirumazhisai, Chennai-600 20mg BP+ 10mg BP + 1mg BP Pharmacy Godown
CALCIUM PANTOLENATE + FOLIC ACID 124, India

1150 P2408 MECOBALAMIN JP + ALPHA LIPOIC ACID Mecobion-OD Medley Pharmaceuticals Ltd, Film coated tablet 1500mcg + 100mg + 200mcg + POM R 06.10.2010 Registered by ADK
USP + CHROMIUM PICOLINATE USP + India. 3mg + 45mg + 1.5mg + 50mg Company Pvt Ltd
PYRIDOXINE HYDROCHLORIDE IP +
NICOTINAMIDE IP + FOLIC ACID IP +
CALCIUM PANTOTHENATE IP
1151 P1883 MEDROXYPROGESTERONE Megestron Organon, Netherland Injection 150mg/ml POM R E

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 71 of 113 Authorized by:DG,MFDA
 1152 P4427 MEDROXYPROGESTERONE ACETATE Depo Progestin P.T. Harsen Laboratories JI. Injection 150mg/ml POM Re E 19.03.2019 - Market Exclusivity
Raya Bogor KM 24,6, Jakarta (suspension) 18.03.2024 given to ADK
Timur-13750, Indonesia Pharmaceutical
Company Pvt. Ltd.
1153 P153 MEFENAMIC ACID Meftal P Blue Cross Laboratories India Tablet 100 mg OTC R E Registered by ADK
Company Pvt Ltd
1154 P482 MEFENAMIC ACID Mefnac Efroze Pakistan Tablet 250 mg OTC R E Registered by Green
Pharmacy
1155 P484 MEFENAMIC ACID Mefnac DS Efroze Pakistan Tablet 500 mg OTC R E Registered by Green
Pharmacy
1156 P3946 MEFENAMIC ACID Axcel Mefenamic Kotra Pharma (M) Sdn. Bhd., Suspension 125 mg per 5ml (60ml bottle) POM Re 01.11.2016 - Market Exclusivity
Acid 1, 2, & 3 Jalan TTC 12, Cheng 31.10.2021 given to State Trading
Industrial Estate, 75250 Organization Plc.
Melaka, Malaysia

1157 P4272 MEFENAMIC ACID Mefcid SM Phamaceuticals SDN BHD Film coated tablet 500mg POM Re 17.04.2018 - Market Exclusivity
(218620-M) Lot 88, Sungai 16.04.2023 given to Green
Petani, Industrial Estate, Pharmacy Godown
08000 Sungai Petani, Kedah,
Malaysia
1158 P3934 MEFENAMIC ACID Pontalon Y.S.P. Industries (M) Sdn. Bhd. Capsule 250 mg POM Re 01.11.2016 - Market Exclusivity
Lot 3, 5 & 7, Jalan P/7, Section 31.10.2021 given to Treetop
13, Kawasan Perindustrian Health Pvt. Ltd.
Bandar Baru bangi, 43000
Kajang, Selangor Darul Ehsan,
Malaysia

1159 P3519 MEFENAMIC ACID BP Mefanor-500 Atoz Pharmaceuticals, India Tablet 500 mg POM Re 19.05.2015- Market Exclusivity
18.05.2020 given to My Chemist
Wholesale
1160 P152 MEFENAMIC ACID BP Meftal Blue Cross Laboratories India Tablet 500 mg OTC R E Registered by ADK
Company Pvt Ltd
1161 P2496 MEFENAMIC ACID BP Moniban Arvind Remedies Ltd, India Tablet 500 mg OTC R 23.02.2011 Registered by Green
Pharmacy
1162 P2694 MEFENAMIC ACID BP Mefril 500 Micro Labs ltd Tablet 500 mg OTC R 28.01.2013 Registered by ADK
Company Pvt Ltd
1163 P1834 MENTHOL + METHYL PARABEN + PROPYL Menzza Ice HOE Pharmaceutical Gel 4% w/w + 0.08% w/w + 0.02% OTC R
PARABEN Manufacturing (M) Sdn. Bhd., w/w
Malaysia
1164 P3935 MEROPENAM TRIHYDRATE USP Merofen 0.5g PT. DANKOS FARMA, Kawasan Powder for 0.5 g POM Re 01.11.2016 - Market Exclusivity
Industri Pulagadung, JI. Rawa Injection 31.10.2021 given to State Trading
Gatel Blok III S, Kav. 36 - 38, Organization Plc.
Jakata, Indonesia

1165 P3936 MEROPENAM TRIHYDRATE USP Merofen 1g PT. DANKOS FARMA, Kawasan Powder for 1g POM Re 01.11.2016 - Market Exclusivity
Industri Pulagadung, JI. Rawa Injection 31.10.2021 given to State Trading
Gatel Blok III S, Kav. 36 - 38, Organization Plc.
Jakata, Indonesia

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 72 of 113 Authorized by:DG,MFDA
 1166 P2695 METAPROLOL USP Metapro - XL Micro Labs ltd Tablet 50 mg POM R 28.01.2013 Registered by ADK
Company Pvt Ltd
1167 P2435 METFORMIN HCL Bigomet 850 Aristo India Tablet 850 mg POM R 23.11.2010 Registered by ADK
Company Pvt Ltd
1168 P2875 METFORMIN HCL Xmet ER 500 Glenmark , India Tablet 500 mg POM R E 07.01.2014 Registered by ADK
Company Pvt Ltd
1169 P2506 METFORMIN HCL Glucophage 850 Merck Limited, Pakistan Tablet 850 mg POM R 25.1.2011 Registered by ADK
Company Pvt Ltd
1170 P2860 METFORMIN HCL Diabetmin XR 500 Hovid Bhd, Malaysia Tablet 500 mg POM R E 07.11.2013 Registered by GKT
Pharmacy
1171 P2728 METFORMIN HCL Diabetmin Hovid Bhd, Malaysia Tablet 850 mg POM R E 05.03.2013 Registered by GKT
Pharmacy
1172 P2182 METFORMIN HCL Glucon 500 Aegis Ltd Tablet 500 mg POM R E
1173 P2183 METFORMIN HCL Glucon 850 Aegis Ltd Tablet 850 mg POM R E
1174 P1795 METFORMIN HCL Forminal Alembic Pharmaceuticals Tablet 500 mg POM R E
Limited India
1175 P1962 METFORMIN HCL Comet 500 Square Pharmaceuticals, Tablet 500 mg POM R E
Bangladesh
1176 P1680 METFORMIN HCL Glycomet USV, India Tablet 500 mg POM R E
1177 P1681 METFORMIN HCL Glycomet USV, India Tablet 850 mg POM R E
1178 P3581 METFORMIN HCL Glumet XR Pharmaniaga Manufacturing Extended Release 750 mg POM Re E 20.10.2015- Market Exclusivity
Berhad, 11A, Jalan P/1, Tablet 19.10.2020 given to Dial Trade
Kawasan Perusahaan Bangi, and Travels Pte. Ltd.
43650 Bandar Baru Bangi,
Selangor Darul Ehsan,
Malaysia

1179 P3582 METFORMIN HCL Glumet XR Pharmaniaga Manufacturing Extended Release 500 mg POM Re E 20.10.2015- Market Exclusivity
Berhad, 11A, Jalan P/1, Tablet 19.10.2020 given to Dial Trade
Kawasan Perusahaan Bangi, and Travels Pte. Ltd.
43650 Bandar Baru Bangi,
Selangor Darul Ehsan,
Malaysia

1180 P3586 METFORMIN HCL Glumet - forte Pharmaniaga Manufacturing film coated Tablet 850 mg POM Re 20.10.2015- Market Exclusivity
Berhad, 11A, Jalan P/1, 19..10.2020 given to Dial Trade
Kawasan Perusahaan Bangi, and Travels Pte. Ltd.
43650 Bandar Baru Bangi,
Selangor Darul Ehsan,
Malaysia

1181 P3629 METFORMIN HCL Metadien Wockardt Limited , India Extended Release 500 mg POM Re 17.11.2015- Market Exclusivity
Tablet 16.11.2020 given to Life Support
Pvt. Ltd.
1182 P2204 METFORMIN HCL BP Melmet 500 Micro Labs ltd Tablet 500 mg POM R E Registered by ADK
Company Pvt Ltd
1183 P2047 METFORMIN HCL BP Emformin Medopharm, India Tablet 500 mg POM R E Registered by Green
Pharmacy
1184 P2666 METFORMIN HCL BP Diabetmin Hovid Bhd, Malaysia Tablet 500 mg POM R E 27.11.2012 Registered by GKT
Pharmacy

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 73 of 113 Authorized by:DG,MFDA
 1185 P2709 METFORMIN HCL BP Dibeta SR Torrent Pharmaceuticals, Tablet 500 mg POM R E 19.02.2013 Registered by Life
India Support Pvt Ltd
1186 P2625 METFORMIN HCL BP Melmet 1000 SR Micro Labs ltd Tablet (SR) 1000 mg POM R 18.09.2012 Registered by ADK
Company Pvt Ltd
1187 P3124 METFORMIN HCL BP Xmet 500 Glenmark , India Tablet 500 mg POM R E 08.07.2014 Registered by ADK
Company Pvt Ltd
1188 P3156 METFORMIN HCL BP Xmet 850 Glenmark , India Tablet 850 mg POM R E 19.08.2014 Registered by ADK
Company Pvt Ltd
1189 P2388 METFORMIN HCL IP Glyciphage Franco Indian Remedies Pvt Tablet 850 mg POM R E 08.09.2010 Registered by Green
Ltd India Pharmacy
1190 P3256 METFORMIN HCL IP Obimet Acme Formulation,India Tablet 500 mg POM R E 06.01.2015 Registered by Life
Support Pvt Ltd
1191 P2268 METFORMIN HCL IP Bigomet SR 500 Aristo India Tablet 500 mg POM R Registered by ADK
Company Pvt Ltd
1192 P1943 METFORMIN HCL IP Glyciphage Franco Indian Remedies Pvt Tablet 500 mg POM R E
Ltd India
1193 P4274 METFORMIN HYDROCHLORIDE Glucophage 500 MERCK SANTE, 2 rue du Film coated tablet 500mg POM Re 17.04.2018 - Market Exclusivity
Pressoir Vert, SEMOY, 45400, 16.04.2023 given to State Trading
France Organization Plc.

1194 P4275 METFORMIN HYDROCHLORIDE Glucophage 850 MERCK SANTE, 2 rue du Film coated tablet 850mg POM Re 17.04.2018 - Market Exclusivity
Pressoir Vert, SEMOY, 45400, 16.04.2023 given to State Trading
France Organization Plc.

1195 P4276 METFORMIN HYDROCHLORIDE Glucophage 1000 MERCK SANTE, 2 rue du Film coated tablet 1000mg POM Re 17.04.2018 - Market Exclusivity
Pressoir Vert, SEMOY, 45400, 16.04.2023 given to State Trading
France Organization Plc.

1196 P3981 METFORMIN HYDROCHLORIDE USP Oromet 500 Swiss Garnier Life Sciences, Uncoated Tablet 500mg POM Re 20.06.2017 - Market Exclusivity
No:21-23 Industrial Area, 20.06.2022 given to AMDC Pvt.
Mehatpur, Dist UNA, Ltd.
Himachel Pradesh, 174315,
INDIA

1197 P4348 METFORMIN HYDROCHLORIDE BP Metformin Medley Pharmaceuticals Ltd. Film coated tablet 500mg POM Re E 02.10.2018 - Market Exclusivity
Plot No. 18 & 19, Survey No. 01.10.2023 given to ADK
378/7 & 8, 379/2&3, Zari Pharmaceutical
Causeway Road, Kachigam, Company Pvt. Ltd.
Daman - 396210, India

1198 P3575 METFORMIN HYDROCHLORIDE Ph. Eur. Glucophage Merck (Private) Limited, 7 Jail Film coated tablet 500 mg POM Re E 06.10.2015- Market Exclusivity
Road, Quetta, Pakistan 05.10.2020 given to State Trading
Organization Plc.

1199 P2044 METHOCARBAMOL Robinax Khandelwal Laboratories Pvt Injection 1G POM R

Ltd
1200 P2045 METHOCARBAMOL Robinax Khandelwal Laboratories Pvt Tablet 500 mg POM R
Ltd

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 74 of 113 Authorized by:DG,MFDA
 1201 P3535 METHYL SALICYLATE + MENTHOL + Ultimax Hovid Bhd, Malaysia Cream 25.5% + 3.3%+ 10% w/w OTC Re 19.05.2015- Market Exclusivity
EUCALYPTUS OIL 18.05.2020 given to My Chemist
Wholesale
1202 P3564 METHYL SALICYLATE + MENTHOL + Hovid Minyak Hovid Bhd. 121, Jalan Tunku Medicated Oil 17.9% w/w + 16.00% w/w+ OTC Re 08.09.2015 - Market Exclusivity
CAMPHOR + EUCALYPTUS OIL + SPIKE Anginl Abdul Rahman, 30010 Ipoh, 10.1% w/w + 9.4% w/w + 4.5% 07.09.2020 given to My Chemist
LAVENDER + PEPPERMINT OIL + CAPSICUM Malaysia w/w + 1.3% w/w + 1.0%w/w Wholesale
OLEORESIN
1203 P1833 METHYL SALICYLATE + MENTHOL + METHYL Menzza HOE Pharmaceutical Cream 250 mg + 50 mg + 0.15% + OTC R Registered by Dial
PARABEN + PROPYL PARABEN Manufacturing (M) Sdn. Bhd., 0.02% Trade and Travels Pte.
Malaysia Ltd.
1204 P2795 METHYL TESTOSTERONE Menwin Pharmix Laboratorie, Pakistan Tablet 25 mg POM R 05.06.2013 Registered by Life
Support Pvt Ltd
1205 P2858 METHYLDOPA Dopatab Hovid Bhd, Malaysia Tablet 250 mg POM R 07.11.2013 Registered by GKT
Pharmacy
1206 P2578 METHYLPREDNISOLONE ACETATE Medixon 4 Dexa Medica, Indonesia Tablet 4 mg POM R 03.04.2012 Registered by ADK
Company Pvt Ltd
1207 P2579 METHYLPREDNISOLONE ACETATE Medixon 16 Dexa Medica, Indonesia Tablet 16mg POM R 03.04.2012 Registered by ADK
Company Pvt Ltd
1208 P3209 METOCLOPRAMIDE BP Metolon Hovid Bhd, Malaysia Tablet 10 mg POM R 06.11.2014 Registered by GKT
Pharmacy
1209 P4281 METOCLOPRAMIDE HYDROCHLORIDE Axcel Kotra Pharma (M) Sdn. Bhd., Tablet 10mg POM Re 17.04.2018 - Market Exclusivity
Metoclopramide 1, 2 & 3 Jalan TTC 12, Cheng 16.04.2023 given to State Trading
Industrial Estate, 75250 Organization Plc.
Melaka, Malaysia

1210 P2425 METRONIDAZOLE Aristogyl Aristo India Oral Liquid 100mg/5 ml POM R E 25.10.2010 Registered by ADK
Company Pvt Ltd
1211 P3121 METRONIDAZOLE Metronidazole Cresent Pharma,London Tablet 200 mg POM R E 08.07.2014 Registered by Life
Support Pvt Ltd
1212 P119 METRONIDAZOLE Metronidazole Baxter Ltd, India. Injection 500mg POM R E Registered by ADK
Company Pvt Ltd

1213 P1656 METRONIDAZOLE Metrogyl Unique, India Gel 1% POM R E Registered by ADK
Company Pvt Ltd
1214 P2568 METRONIDAZOLE Flagyl Sanofi Bangladesh Ltd Injection 500 mg/100ml POM R E 31.01.2012 Registered by ADK
Company Pvt Ltd

1215 P2565 METRONIDAZOLE Flagyl 400 Sanofi Bangladesh Ltd Tablet 400 POM R E 31.01.2012 Registered by ADK
Company Pvt Ltd
1216 P2566 METRONIDAZOLE Flagyl 200 Sanofi Bangladesh Ltd Tablet 200 POM R E 31.01.2012 Registered by ADK
Company Pvt Ltd
1217 P551 METRONIDAZOLE Fresogyl Fresenius Kabi, India Injection 100ml POM R E

1218 P1984 METRONIDAZOLE Flazole Vaginal Cipla India Suppository 500 mg POM R E 23.05.2005
Suppository
1219 P2214 METRONIDAZOLE BP Rogyl 400 Medopharm, India Tablet 400 mg POM R E Registered by Green
Pharmacy
1220 P2116 METRONIDAZOLE BP Rogyl Medopharm, India Tablet 200 mg POM R Registered by Green
Pharmacy

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 75 of 113 Authorized by:DG,MFDA
 1221 P3685 METRONIDAZOLE BP + CLOTRIMAZOLE BP + Klovinal Bliss GVS Pharma Limited, Vaginal 500 mg + 100 mg + 150 Million POM Re 01.03.2016- Market Exclusivity
LACTOBACILLUS India Suppositories Spores 28.02.2021 given to Green
Pharmacy Godown
1222 P2410 METRONIDAZOLE IP Aristogyl 200 Aristo India Tablet 200 mg POM R 07.10.2010 Registered by ADK
Company Pvt Ltd
1223 P2409 METRONIDAZOLE IP Aristogyl 400 Aristo India Tablet 400 mg POM R 07.10.2010 Registered by ADK
Company Pvt Ltd
1224 P1112 METRONIDAZOLE USP Metronidazole Marck Bio Sciences Ltd,India Injection 5g /L POM R E
Injection U. S. P.

1225 P3139 METRONIDAZOLE USP Metroflag Axa Parentrals limited Injection 500 mg in 100ml POM R E 19.08.2014 Registered by Medlab
Diagnostics Pvt. Ltd.

1226 P2348 MICONAZOLE Menzza NP HOE Pharmaceutical Cream 0.075% OTC R 26.05.2010 Registered by Dial
Manufacturing (M) Sdn. Bhd., Trade and Travels Pte.
Malaysia Ltd.
1227 P2346 MICONAZOLE Decozol HOE Pharmaceuticals Sdn. Oral Gel 2% w/w (15g) OTC Re E 19.03.2019 - Market Exclusivity
Bhd., Lot 10, Jalan Sultan 18.03.2024 given to Dial Trade and
Mohamed. 6, Bandar Sultan Travels Pte. Ltd.
Suleiman, 42000 Port Klang,
Malaysia

1228 P865 MICONAZOLE Decozole HOE Pharmaceutical Cream 2% w/w 15g POM R E 26.05.2010 Registered by Dial
Manufacturing (M) Sdn. Bhd., Trade and Travels Pte.
Malaysia Ltd.
1229 P2149 MICONAZOLE BP Armizole Arvind Remedies Ltd, India Cream 2% POM R E

1230 P4353 MICONAZOLE NITRATE Zarin Xepa-Soul Pattinson Cream 2% w/w (15g) POM Re 16.10.2018 - Market Exclusivity
(Malaysia) SDN. BHD. 1-5 15.10.2023 given to ADK
Cheng Industrial Estate, 75250 Pharmaceutical
Melaka, Malaysia Company Pvt. Ltd.
1231 P4432 MICONAZOLE NITRATE + HYDROCORTISONE Zaricort Xepa-Soul Pattinson Cream 2% w/w + 1% w/w (15g) POM Re E 19.03.2019 - Market Exclusivity
(Malaysia) SDN. BHD. 1-5 18.03.2024 given to ADK
Cheng Industrial Estate, 75250 Pharmaceuticals
Melaka, Malaysia Company Pvt. Ltd.
1232 P3268 MICONAZOLE NITRATE BP + Drez -V Stedman Pharmaceuticals, Gel (Vaginal ) 2% w/w + 1 % POM R 06.01.2015 Registered by AMDC
METRONIDAZOLE BP India Pvt Ltd
1233 P2759 MIDAZOLAM Mezolam Neon Laboratories, India Tablet 5 mg INTERNATIONALLY R 08.05.2013 Registerd by State
CONTROLLED Trading Organization
(PSYCHOTROPIC) Plc.
1234 P2746 MOMETASONE Elosone HOE Pharmaceutical Cream 0.1% POM R 08.05.2013 Registered by Dial
Manufacturing (M) Sdn. Bhd., Trade and Travels Pte.
Malaysia Ltd.
1235 P2745 MOMETASONE Elosone HOE Pharmaceutical Ointment 0.1% POM R 08.05.2013 Registered by Dial
Manufacturing (M) Sdn. Bhd., Trade and Travels Pte.
Malaysia Ltd.
1236 P2635 MOMETASONE FUROATE + SALICYLIC ACID Momate S Glenmark , India Ointment 1mg + 50 mg POM R 18.09.2012 Registered by ADK
USP Company Pvt Ltd

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 76 of 113 Authorized by:DG,MFDA
 1237 P3606 MOMETASONE FUROATE MONOHYDRATE Momate Glenmark Pharmaceuticals Nasal Spray 0.05% w/w (50 mcg /spray) POM Re 06.10.2015 - Market Exclusivity
Ltd., At:Village: Kishanpura, 05.10.2020 given to ADK Company
Baddi-Nalagarh Road, Tehsil Pvt. Ltd.
Baddi, Distt. Solan, (H.P.) - 173
205, India

1238 P826 MOMETASONE USP Momate Glenmark , India Ointment 0.1% 5g POM R Registered by ADK
Company Pvt Ltd
1239 P2343 MOMETASONE USP Momate Glenmark , India Cream 0.1% 15 g POM R 13.05.2010 Registered by ADK
Company Pvt Ltd
1240 P2395 MONTELUKAST Montair Incepta pharmaceuticals Tablet 4 mg POM R 02.09.2010 Registered by Dial
Limited, Bangladesh Trade and Travels Pte.
Ltd.
1241 P2396 MONTELUKAST Montair Incepta pharmaceuticals Tablet 5 mg POM R 02.09.2010 Registered by Dial
Limited, Bangladesh Trade and Travels Pte.
Ltd.
1242 P2696 MONTELUKAST Monest-5 Micro Labs Limited, 92, Tablet 5 mg POM R 28.01.2013 Registered by ADK
SIPCOT, HOSUR-635 126 INDIA Company Pvt Ltd

1243 P2770 MONTELUKAST Monteka 5 Atoz Pharmaceuticals ,India Tablet 5 mg POM R 05.06.2013 Registered by My
Chemist Wholesale

1244 P2750 MONTELUKAST Glemont 10 IR Glenmark , India IR Tablet 10 mg POM R 08.05.2013 Registered by ADK
Company Pvt Ltd
1245 P2758 MONTELUKAST Montelair Hovid Bhd, Malaysia Tablet 10mg POM R 08.05.2013 Registered by GKT
Pharmacy
1246 P2325 MONTELUKAST Montef Efroze Pakistan Tablet 10 mg POM R
1247 P3457 MONTELUKAST Montair Incepta pharmaceuticals Tablet 10mg POM Re 24.03.2015 - Market Exclusivity
Limited, Bangladesh 23.03.2020 given to Dial Trade
and Travels Pte. Ltd.
1248 P2691 MONTELUKAST IP Glemont CT Glenmark , India Tablet 4 mg POM R 28.01.2013 Registered by ADK
Company Pvt Ltd
1249 P2692 MONTELUKAST IP Glemont CT Glenmark , India Tablet 5 mg POM R 28.01.2013 Registered by ADK
Company Pvt Ltd
1250 P3980 MONTELUKAST SODIUM Aspira 10 Pharmaniaga Manufacturing Tablet 10mg POM Re 20.06.2017 - Market Exclusivity
Berhad, 11A, Jalan P/1, 20.06.2022 given to Dial Trade
Kawasan Perusahaan Bangi, and Travels Pte. Ltd.
Bandar Baru Bangi, Selangor
Darul Ehsan, Malaysia

1251 P3988 MONTELUKAST SODIUM Monteluk CCL Pharmaceuticals (Pvt) Ltd, Chewable tablet 5 mg POM Re 01.08.2017 - Market Exclusivity
62-Industrial estate, Kot 01.08.2022 given to State Trading
lakhpat, Lahore, Pakistan Organization Plc.

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 77 of 113 Authorized by:DG,MFDA
 1252 P3989 MONTELUKAST SODIUM Monteluk CCL Pharmaceuticals (Pvt) Ltd, Film coated tablet 10 mg POM Re 01.08.2017 - Market Exclusivity
62-Industrial estate, Kot 01.08.2022 given to State Trading
lakhpat, Lahore, Pakistan Organization Plc.

1253 P2771 MONTELUKAST USP Monteka 10 Atoz Pharmaceuticals ,India Tablet 10mg POM R 05.06.2013 Registered by My
Chemist Wholesale

1254 P3714 MOXIFLOXACIN Ocumox Remington Pharmaceutical Eye Ointment 0.5% (5mg) BP/g (3.5g) POM Re 17.05.2016 - Market Exclusivity
Industries, Pakistan 16.05.2021 given to ADK
Pharmaceutical
Company Pvt. Ltd.
1255 P2886 MOXIFLOXACIN HYDROCHLORIDE Vigamox Alcon Laboratories INC. Fort Ophthalmic 5.45mg (eqv.5mg/ml) in 5ml POM Re 19.03.2019 - Market Exclusivity
Worth Texas 76134, USA Solution bottle 18.03.2024 given to ADK
Pharmaceutical
Company Pvt. Ltd.
1256 P3496 MOXIFLOXACIN HYDROCHLORIDE Optimox Eye Drops Aristo Pharma Limited, Eye Drops 0.5% POM Re 19.05.2015- Market Exclusivity
Bangladesh 18.05.2020 given to Life Support
Pvt. Ltd.
1257 P3544 MOXIFLOXACIN HYDROCHLORIDE Ocumox Remington Pharmaceutical Eye Drops 0.5% POM Re 30.06.2015 - Market Exclusivity
Industries, Pakistan 29.06.2020 given to ADK Company
Pvt. Ltd.
1258 P4158 MULTI VITAMINS + IRON + IODINE Ovron Astron Ltd, SriLanka Capsule 45mg + 50mcg OTC R Registered by ADK
Company Pvt Ltd
1259 P2280 MULTIVITAMIN AND MINERALS Ovran Astron Limited, Sri Lanka Capsule POM R Registered by ADK
Company Pvt Ltd
1260 P2333 MUPIROCIN Bactroban GlaxoSmithKline, Phillipines Ointment 2% OTC R E 09.05.2010 Registered by ADK
Company Pvt Ltd
1261 P782 MUPIROCIN Bactroban GlaxoSmithKline, Phillipines Cream 2% OTC R E Registered by ADK
Company Pvt Ltd
1262 P4326 MUPIROCIN Bactricin SM Pharmaceuticals Sdn. Bhd. Ointment 2.0% w/w (15g tube) POM Re E 02.10.2018 - Market Exclusivity
Lot 88, Sungai Petani 01.10.2023 given to Green
Industrial Estate, 08000 Pharmacy Godown
Sungai Petani, Kedah,
Malaysia
1263 P2537 Mupirocin Muprin HOE Pharmaceutical Ointment 2% w/w OTC R Registered by Dial
Manufacturing (M) Sdn. Bhd., Trade and Travels Pte.
Malaysia Ltd.
1264 P2226 MUPIROCIN USP Mupirax Ointment Micro Labs ltd Ointment 2% OTC R E Registered by ADK
Company Pvt Ltd
1265 P801 MUPIROCIN USP Supirocin Glenmark , India Topical Ointment 2% OTC R E 02.11.2011 Registered by ADK
Ointments Company Pvt Ltd
1266 P1996 MUPIROCIN USP + BETAMETHASONE Supirocin B Oint Glenmark , India Ointment 2% w/w + 0.05w/w POM R
DIPROPIONATE USP
1267 P1489 MYCOPHENOLATE MOFETIL IP CellCept F. Hoffmann-La Roche Ltd, Film coated tablet 500 mg POM R
Grenzacherstrasse 124, CH-
4070 Basel, Switzerland at
Roche S.p.A., Via Morelli, No.
2, 20090 Segrate, Milan, Italy

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 78 of 113 Authorized by:DG,MFDA
 1268 P2305 MYCOPHENOLATE SODIUM Myfortic 180 Novartis Pharma AG, Tablet 180 mg POM R 02.02.2010 Registerd by State
Switzerland Trading Organization
Plc.
1269 P2306 MYCOPHENOLATE SODIUM Myfortic 360 Novartis Pharma AG, Tablet 360 mg POM R 02.02.2010 Registerd by State
Switzerland Trading Organization
Plc.
1270 P4343 MYCOPHENOLATE SODIUM Myfortic Novartis Pharma Produktion Gastro-resistant 360mg POM Re E 16.10.2018 - Market Exclusivity
(MYCOPHENOLIC ACID) GmbH, Oeflinger Str 44 79664, tablet 15.10.2023 given to State Trading
Wehr, Germany Organization Plc.

1271 P4344 MYCOPHENOLATE SODIUM Myfortic Novartis Pharma Produktion Gastro-resistant 180mg POM Re E 16.10.2018 - Market Exclusivity
(MYCOPHENOLIC ACID) GmbH, Oeflinger Str 44 79664, tablet 15.10.2023 given to State Trading
Wehr, Germany Organization Plc.

1272 P2500 NALIDIXIC ACID Neganil Arvind Remedies Ltd, India Tablet 500 mg BP POM R 23.02.2011 Registered by Green
Pharmacy
1273 P19 NAPHAZOLINE HYDROCHLORIDE + Naphcon - A Alcon Couvreur N.V Rijksweg Ophthalmic 0.025% w/v (0.25mg/ml) + POM Re 19.03.2019 - Market Exclusivity
PHENIRAMINE MALEATE 14, B-2870, Puurs, Belgium Solution 0.3% w/v (3mg/ml) 18.03.2024 given to ADK
Pharmaceutical
Company Pvt. Ltd.
1274 P1921 NAPHAZOLINE, ANTAZOLINE Napha Eye Drops Upha Pharmaceutical Eye Drops POM R
Manufacturing (M) Sdn. Bhd.,
Malaysia
1275 P327 NAPROXEN Naxen Douglas New Zealand Tablet 250 mg POM R E
1276 P328 NAPROXEN Naxen Douglas New Zealand Tablet 500 mg POM R E
1277 P2903 NAPROXEN Naproxen Cresent Pharma, London Tablet 500 mg POM R 18.02.2014 Registered by Life
Support Pvt Ltd
1278 P2217 NAPROXEN Neoprox 250 Merck Limited, Pakistan Tablet 250 mg POM R E Registered by ADK
Company Pvt Ltd
1279 P2218 NAPROXEN Neoprox 500 Merck Limited, Pakistan Tablet 500 mg POM R E Registered by ADK
Company Pvt Ltd
1280 P3801 NAPROXEN BP Ticoflex Incepta Pharmaceuticals Ltd, Tablet 500mg POM Re 11.10.2016- Market Exclusivity
Dewan Idris Road, Bara 10.10.2021 given to Dial Trade
Rangamatia, Zirabo, Savar, and Travels Pte. Ltd.
Dhaka, Bangladesh

1281 P3802 NAPROXEN BP Ticoflex Incepta Pharmaceuticals Ltd, Tablet 250mg POM Re 11.10.2016- Market Exclusivity
Dewan Idris Road, Bara 10.10.2021 given to Dial Trade
Rangamatia, Zirabo, Savar, and Travels Pte. Ltd.
Dhaka, Bangladesh

1282 P3729 NATURAL FISH OIL+VITAMIN A+VITAMIN Champs Omega 3 Upha Pharmaceutical Chewable Sugar 62.5mg+11.25mg+7.5mg+2000 POM Re 24.05.2016 - Market Exclusivity
D+VITAMIN E+VITAMIN C+VITAMIN Plus Manufacturing (M) Sdn. Bhd., free Tablet IU+150IU+15mg+15mg+60mg+ 23.05.2021 given to Dial Trade
B1+VITAMIN B2+VITAMIN B6+VITAMIN Malaysia 0.5mg+0.5mg+0.5mg+2mcg+6 and Travels Pte. Ltd.
B12+NICOTINAMIDE mg
1283 P2519 NEBIVOLOL IP Nevol 2.5 Medley Ltd, India. Tablet 2.5 mg POM R 23.06.2011 Registered by ADK
Company Pvt Ltd
1284 P2520 NEBIVOLOL IP Nevol 5 Medley Ltd, India. Tablet 5 mg POM R 23.06.2011 Registered by ADK
Company Pvt Ltd

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Rev. No.: 02 Page 79 of 113 Authorized by:DG,MFDA
 1285 P2913 NEPAFENAC Nevanac Alcon Couvreur N.V Rijksweg Eye Drops 1mg/ml POM Re 19.03.2019 - Market Exclusivity
14, B-2870, Puurs, Belgium 18.03.2024 given to ADK
Pharmaceutical
Company Pvt. Ltd.
1286 P3269 NEPAFENAC Nepanac Remington Pharmaceuticals, Eye Drops 0.1% (1 mg) POM R 06.01.2015 Registered by ADK
Pakistan Company Pvt Ltd

1287 P3498 NEPAFENAC Nevan Aristo Pharma Limited, Ophthalmic 0.1% POM Re 19.05.2015- Market Exclusivity
Bangladesh Solution 18.05.2020 given to Life Support
Pvt. Ltd.
1288 P4439 NEPAFENAC Nevanac Alcon Laboratories INC. Fort Eye Drops 1mg/ml POM Re 19.03.2019 - Market Exclusivity
Worth Texas 76134, USA 18.03.2024 given to ADK
Pharmaceuticals
Company Pvt. Ltd.
1289 P2733 NIACIN + PANTOTHENIC ACID + VITAMIN B2 Sunlife Vitamin B - Sunlife Laboratories, Germany Tablet (Chewable) 20 mg + 255 mg + 2 mg+ 2 POM R 16.04.2013 Registered by ADK
+ VITAMIN B 6 + VITAMIN B 12 Complex Chewable mg+ 2 μg Company Pvt Ltd
Tablet

1290 P2719 NIFEDIPINE BP Calcigard Retard Torrent Pharmaceuticals, Tablet (SR) 20 mg POM R 19.02.2013 Registered by Life
India Support Pvt Ltd
1291 P3100 NIFEDIPINE BP Nifedipine 10 Sai Mirra Innopharm Pvt Ltd, Tablet 10mg POM R 20.05.2014 Registered by AMDC
India Pvt Ltd
1292 P3674 NILOTINIB Tasigna Novartis Pharma Stein AG, Capsule 150 mg POM Re 23.02.2016 - Market Exclusivity
Stein Switzerland 22.02.2021 given to Mediquip
Maldives Pvt. Ltd.
1293 P3695 NILOTINIB Tasigna Novartis Pharma Stein AG, Capsule 200 mg POM Re 23.02.2016 - Market Exclusivity
Stein Switzerland 22.02.2021 given to Mediquip
Maldives Pvt. Ltd.
1294 P1682 NIMODIPINE Nimodip USV, India Tablet 30 mg POM R
1295 P3116 NITROUS OXIDE + OXYGEN Entonox Ceylon Oxygen Limited, Medical Gas 50% Nitrous Oxide + 50% Restricted for R 24.06.2014 Registered by Maldives
Srilanka Oxygen(Pre mixed ) Hospital use only Gas

1296 P281 NORFLOXACIN Norflox Cipla India Eye Drops 0.30% POM R E 13.05.10 Registered by ADK
Company Pvt Ltd
1297 P154 NORFLOXACIN Norspan Blue Cross Laboratories India Tablet 400 mg POM R E Registered by ADK
Company Pvt Ltd
1298 P2442 NORFLOXACIN Emnor Medopharm, India Tablet 400 mg POM R E 22.10.2010 Registered by Green
Pharmacy
1299 P59 NYSTATIN Candistatin V Ambalal Sarabhai Tablet (Vaginal) 10,000 Units POM R E 09.05.2014 Registered by ADK
India/Assence Pharma Pvt Ltd Company Pvt Ltd

1300 P1151 OFLOXACIN Ofoxin 400 Medley Ltd, India. Tablet 400mg POM R Registered by ADK
Company Pvt Ltd
1301 P2109 OFLOXACIN Alfacin Eye Drops Ashford Laboratories Ltd Eye Drops 3 mg POM R

1302 P2135 OFLOXACIN Ofla 400 Khandelwal Laboratories Pvt Tablet 400 mg POM R
Ltd
1303 P3103 OFLOXACIN IP Oflox Cipla India Eye Drops 0.03% POM R 20.05.2014 Registered by ADK
Company Pvt Ltd

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 80 of 113 Authorized by:DG,MFDA
 1304 P2480 OFLOXACIN USP Nichflox MMC Health Care Ltd,India Tablet 400 mg POM R 23.02.2011 Registered by Green
Pharmacy
1305 P2497 OFLOXACIN USP Offcin Arvind Remedies Ltd, India Tablet 200 mg POM R 23.02.2011 Registered by Green
Pharmacy
1306 P1150 OFLOXACIN USP Ofoxin 200 Medley Ltd, India. Tablet 200mg POM R Registered By ADK
Company Pvt Ltd
1307 P3198 OFLOXACIN USP Rutix 200 Square Pharmaceuticals, Tablet 200 mg POM R E 06.11.2014 Registered by Dial
Bangladesh Trade and Travels Pte.
Ltd.
1308 P3199 OFLOXACIN USP Rutix 400 Square Pharmaceuticals, Tablet 400 mg POM R E 06.11.2014 Registered by Dial
Bangladesh Trade and Travels Pte.
Ltd.
1309 P3648 OFLOXACIN USP Kunoxy Plus Remington Pharmaceutical Ear Drops 0.6% POM Re 21.01.2016 - Market Exclusivity
Industries Pvt. Ltd., 18 Km 20.01.2021 given to ADK Company
Multan Road, Lahore, Pvt. Ltd.
Pakistan

1310 P2244 OLANZAPINE OLAN 5 Micro Labs ltd Tablet 5 mg NATIONALLY R Registered by ADK
CONTROLLED Company Pvt Ltd
(PSYCHOTROPIC)
1311 P2676 OLANZAPINE Olpin East West Pharma,India Tablet 2.5 mg NATIONALLY R 22.01.2013 Registerd by State
CONTROLLED Trading Organization
(PSYCHOTROPIC) Plc.
1312 P2677 OLANZAPINE Olpin East West Pharma,India Tablet 5 mg NATIONALLY R 22.01.2013 Registerd by State
CONTROLLED Trading Organization
(PSYCHOTROPIC) Plc.
1313 P2678 OLANZAPINE Olpin East West Pharma,India Tablet 10 mg NATIONALLY R 22.01.2013 Registerd by State
CONTROLLED Trading Organization
(PSYCHOTROPIC) Plc.
1314 P3979 OLMESARTAN MEDOXOMIL PH. EUR. Benitec 40 Hetero Labs Limited (Unit III), Film-coated tablet 40mg POM Re 06.06.2017 - Market Exclusivity
At: Kalyanpur (Village) 06.06.2022 given to State Trading
Chakkan Road, Baddi (Tehsil), Organization Plc.
Solan (Distt.), Himachal
Pradesh - 173 205, INDIA

1315 P3503 OLOPATADINE Olpadin DS Aristo Pharma Limited, Eye Drops 0.2% POM Re 19.05.2015- Market Exclusivity
Bangladesh 18.05.2020 given to Life Support
Pvt. Ltd.
1316 P1791 OLOPATADINE HYDROCHLORIDE Patanol Alcon, Singapore Eye Drops 0.1% w/v POM R
1317 P3200 OLOPATADINE HYDROCHLORIDE Alacot Square Pharmaceuticals, Eye Drops 1 mg/ml POM R 06.11.2014 Registered by Dial
Bangladesh Trade and Travels Pte.
Ltd.
1318 P4437 OLOPATADINE HYDROCHLORIDE Patanol Alcon Couvreur N.V Rijksweg Ophthalmic 1mg/ml (0.1% w/v) in 5ml POM Re E 19.03.2019 - Market Exclusivity
14, B-2870, Puurs, Belgium Solution 18.03.2024 given to ADK
Pharmaceuticals
Company Pvt. Ltd.
1319 P4438 OLOPATADINE HYDROCHLORIDE Patanol Alcon Laboratories INC. Fort Ophthalmic 1mg/ml (0.1% w/v) in 5ml POM Re E 19.03.2019 - Market Exclusivity
Worth Texas 76134, USA Solution 18.03.2024 given to ADK
Pharmaceuticals
Company Pvt. Ltd.

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 81 of 113 Authorized by:DG,MFDA
 1320 P4071 OLOPATADINE HYDROCHLORIDE Zolopat Forte Remington Pharmaceutical Sterile Ophthalmic 0.2% ( 2mg) POM Re 03.10.2017 - Market Exclusivity
Industries (Pvt) Ltd, 18km Suspension 02.10.2022 given to ADK
Multan Road, Lahore, Pharmaceutical
Pakistan Company Pvt. Ltd.

1321 P2880 OMEPRAZOLE Lomac Cipla India Capsule 20 mg POM R 07.01.2014 Registered by ADK
Company Pvt Ltd
1322 P155 OMEPRAZOLE Omepren Blue Cross Laboratories India Capsule 20 mg BP POM R Registered by ADK
Company Pvt Ltd
1323 P2290 OMEPRAZOLE Omecid Saga Laboratories, India Capsule 20 mg POM R Registered by Dial
Trade and Travels Pte.
Ltd.
1324 P35 OMEPRAZOLE Omezol Alembic Pharmaceuticals Capsule 20mg POM R Registered by Dial
Limited India Trade and Travels Pte.
Ltd.
1325 P2784 OMEPRAZOLE Omezole Hovid Bhd, Malaysia Capsule 20 mg POM R 05.06.2013 Registered by GKT
Pharmacy
1326 P1963 OMEPRAZOLE Seclo 20 Square Formulations Capsule 20 mg POM R
Ltd. Tangail, Bangladesh
1327 P1579 OMEPRAZOLE Trisec Sterling Lab, India. Capsule 20mg POM R
1328 P2704 OMEPRAZOLE BP Omizac Torrent Pharmaceuticals, Capsule 20 mg POM R 19.02.2013 Registered by Life
India Support Pvt Ltd
1329 P3725 OMEPRAZOLE BP Omez Dr.Reddy's Laboratories Capsule 20mg POM Re 17.05.2016 - Market Exclusivity
Ltd.,India 16.05.2021 given to State Trading
Organization Plc.

1330 P4332 OMEPRAZOLE SODIUM (Eqv. OMEPRAZOLE) Vaxcel Omeprazole Kotra Pharma (M) Sdn. Bhd., Injection 40mg/vial POM Re 02.10.2018 - Market Exclusivity
1, Jalan TTC 12, Cheng 01.10.2023 given to State Trading
Industrial Estate, 75250, Organization Plc.
Malaka, Malaysia
1331 P4066 OMEPRAZOLE SODIUM BP Omez Dr.Reddy's Laboratories Injection 40mg/vial POM Re 03.10.2017 - Market Exclusivity
Limited,( Formulation Unit - 6 (Lyophilised) 02.10.2022 given to State Trading
) Village Khol, Nalagarh Organization Plc.
Road, Baddi Dist, Solan , H.P,
(173205) , India

1332 P2146 OMEPRAZOLE USP Armezac 20 Arvind Remedies Ltd, India Capsule (Delayed 20 mg POM R
Release)

1333 P3521 OMEPRAZOLE USP Inopep Atoz Pharmaceuticals, India Capsule 20 mg POM Re 19.05.2015- Market Exclusivity
18.05.2020 given to My Chemist
Wholesale
1334 P3602 OMEPRAZOLE USP OMI 20 Aeon Formulations Pvt. Ltd., Hard gelatin 20 mg POM Re 20.10.2015 - Market Exclusivity
India Capsule (delayed- 19.10.2020 given to Moonima
release pellets) Medicals

1335 P287 ONDANSETRON Emeset Cipla India Injection 2mg/ml POM R E 13.05.2010 Registered by ADK
Company Pvt Ltd

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 82 of 113 Authorized by:DG,MFDA
 1336 P288 ONDANSETRON Emeset Cipla India Tablet 4 mg POM R E 05.11.2009 Registered by ADK
Company Pvt Ltd
1337 P2777 ONDANSETRON Neomit Neon Laboratories, India Tablet 8 mg/2 ml POM R 05.06.2013 Registerd by State
Trading Organization
Plc.
1338 P2778 ONDANSETRON Neomit Neon Laboratories, India Tablet 4 mg/2 ml POM R 05.06.2013 Registerd by State
Trading Organization
Plc.
1339 P1985 ONDANSETRON Emeset Cipla India Suppository 16 mg POM R 23.05.2005
1340 P3152 ONDANSETRON BP Onderon Atoz Pharmaceuticals ,India Tablet 4 mg POM R 19.08.2014 Registered by My
Chemist Wholesale

1341 P1490 ORLISTAT Xenical Roche, Switzerland Capsule 120 mg POM R

1342 P2300 ORNIDAZOLE IP Ornida Aristo India Tablet 500 mg POM R Registered by ADK
Company Pvt Ltd
1343 P2304 OXCARBAZAPINE Trileptal Norvartis Pharma,Italy / Tablet 300 mg POM R 02.02.2010 Registerd by State
Novartis Pharma AG Trading Organization
Switzerland Plc.
1344 P1842 OXYMETAZOLINE OxyNase HOE Pharmaceutical Nasal solution 0.05% in 10ml POM R E
Manufacturing (M) Sdn. Bhd.,
Malaysia
1345 P1844 OXYMETAZOLINE OxyNase HOE Pharmaceutical Nasal solution 0.025% in 10ml POM R E
Manufacturing (M) Sdn. Bhd.,
Malaysia
1346 P1845 OXYMETAZOLINE OxyNase 0.025% HOE Pharmaceutical Nasal Spray 0.025% in 15ml POM R E
Manufacturing (M) Sdn. Bhd.,
Malaysia
1347 P2003 OXYMETAZOLINE Xynose Nasal Liva Health Ltd ,India Nasal solution 0.05% W/V(USP) POM R E Registered by Green
Solution Pharmacy
1348 P3803 OXYMETAZOLINE HYDROCHLORIDE Rynex Incepta Pharmaceuticals Ltd, Nasal Drop 0.25mg (0.025%) BP POM Re 11.10.2016- Market Exclusivity
Dewan Idris Road, Bara 10.10.2021 given to Dial Trade
Rangamatia, Zirabo, Savar, and Travels Pte. Ltd.
Dhaka, Bangladesh

1349 P454 OXYMETAZOLINE HYDROCHLORIDE USP Nasivion Merck Limited, Shiv Sagar Nasal solution (0.25mg) 0.025% in 10ml POM Re E 06.10.2015- Market Exclusivity
(PAEDIATRIC) Estate 'A' Dr. Annie Besant 05.10.2020 given to State Trading
Road, Worli, Mumbai - 400 Organization Plc.
018, India
1350 P453 OXYMETAZOLINE HYDROCHLORIDE USP Nasivion mini Merck Limited, At: D-9, Nasal Drops (0.1mg) 0.01% in 10ml POM Re E 06.10.2015- Market Exclusivity
Industrial Area, Haridwar - 05.10.2020 given to State Trading
249 401, Uttarakhand, India Organization Plc.

1351 P452 OXYMETAZOLINE HYDROCHLORIDE USP Nasivion Merck Limited, Shiv Sagar Nasal solution (0.5mg) 0.05% in 10ml POM Re E 06.10.2015- Market Exclusivity
Estate 'A' Dr. Annie Besant 05.10.2020 given to State Trading
Road, Worli, Mumbai - 400 Organization Plc.
018, India
1352 P1843 OXYMETAZOLINE USP OxyNase HOE Pharmaceutical Nasal Drops 0.05% in 15ml POM R E
Manufacturing (M) Sdn. Bhd.,
Malaysia

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 83 of 113 Authorized by:DG,MFDA
 1353 P2279 OXYTETRACYCLIN +Polymycin B Polymycin Astron Limited, Sri Lanka Ointment 30mg(BP) + 10000 Units (USP) POM R Registered by ADK
Ointment in 1g Company Pvt Ltd
1354 P4073 PACLITAXEL USP Paclihope Glenmark Generics S.A., Calle Injection 30mg/vial (5ml) (6mg/ml) Restricted for Re 03.10.2017 - Market Exclusivity
9 Ing. Meyer Oks N: 593 Hospital Use Only 02.10.2022 given to ADK
Parque Industrial Pilar Buenos Pharmaceutical
Aires, Argentina Company Pvt. Ltd.

1355 P4074 PACLITAXEL USP Paclihope Glenmark Generics S.A., Calle Injection 300mg/vial (50ml) (6mg/ml) Restricted for Re 03.10.2017 - Market Exclusivity
9 Ing. Meyer Oks N: 593 Hospital Use Only 02.10.2022 given to ADK
Parque Industrial Pilar Buenos Pharmaceutical
Aires, Argentina Company Pvt. Ltd.

1356 P2869 PANTOPRAZOLE Zanpan 40 Wallace Pharmaceuticals, Tablet 40 mg POM R 07.01.2014 Registered by AMDC
India Pvt Ltd
1357 P2866 PANTOPRAZOLE Pantoril 40 MMC Health Care Ltd,India Tablet 40 mg POM R 07.01.2014 Registered by Green
Pharmacy
1358 P2274 PANTOPRAZOLE Pantop Aristo India Tablet 40 mg POM R Registered by ADK
Company Pvt Ltd
1359 P1152 PANTOPRAZOLE Pantaz Medley Ltd, India. Tablet 40mg POM R Registered by ADK
Company Pvt Ltd
1360 P2776 PANTOPRAZOLE Gastrozole Atoz Pharmaceuticals ,India Tablet 40 mg POM R 05.06.2013 Registered by My
Chemist Wholesale

1361 P3663 PANTOPRAZOLE Zovanta Dr Reddy`s Laboratories,India Tablet 40 mg POM Re 21.01.2016 - Market Exclusivity
20.01.2021 given to State Trading
Organization Plc.

1362 P3664 PANTOPRAZOLE Zovanta Dr Reddy`s Laboratories,India Tablet 20 mg POM Re 21.01.2016 - Market Exclusivity
20.01.2021 given to State Trading
Organization Plc.

1363 P2710 PANTOPRAZOLE BP Pantor Torrent Pharmaceuticals, Tablet 20 mg POM R E 19.02.2013 Registered by Life
India Support Pvt Ltd
1364 P2711 PANTOPRAZOLE BP Pantor Torrent Pharmaceuticals, Tablet 40 mg POM R E 19.02.2013 Registered by Life
India Support Pvt Ltd
1365 P3162 PANTOPRAZOLE USP Gastrozole Atoz Pharmaceuticals ,India Tablet 20 mg POM R 19.08.2014 Registered by My
Chemist Wholesale

1366 P3148 PANTOPRAZOLE USP + DOMPERIDONE Gastrozole - D Atoz Pharmaceuticals ,India Capsule 40 mg + 30 mg POM R 19.08.2014 Registered by My
Chemist Wholesale

1367 P783 PARACETAMOL Panadol GlaxoSmithKline, SriLanka Tablet 500mg OTC R E Registered by ADK
Company Pvt Ltd
1368 P2053 PARACETAMOL Uphamol Upha Pharmaceutical Oral Liquid 120mg/5ml OTC R E Registered by Dial
Manufacturing (M) Sdn. Bhd., Trade and Travels Pte.
Malaysia Ltd.
1369 P2051 PARACETAMOL Uphamol Upha Pharmaceutical Tablet 650 mg OTC R E Registered by Dial
Manufacturing (M) Sdn. Bhd., Trade and Travels Pte.
Malaysia Ltd.

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 84 of 113 Authorized by:DG,MFDA
 1370 P2052 PARACETAMOL Uphamol Upha Pharmaceutical Oral Liquid 250mg/5 ml OTC R E Registered by Dial
Manufacturing (M) Sdn. Bhd., Trade and Travels Pte.
Malaysia Ltd.
1371 P2905 PARACETAMOL Paracetamol Cresent Pharma,London Tablet 500 mg OTC R E 18.02.2014 Registered by Life
Support Pvt Ltd
1372 P1569 PARACETAMOL Panadol GlaxoSmithKline, SriLanka Oral Drops 80mg/0.8 ml (100mg/ml ) OTC R E Registered by ADK
Company Pvt Ltd
1373 P628 PARACETAMOL Calpol GlaxoSmithKline, SriLanka Oral Liquid 120 mg/5ml OTC R E 21.03.2010 Registered by ADK
Company Pvt Ltd
1374 P1568 PARACETAMOL Panadol GlaxoSmithKline, SriLanka Oral Liquid 120mg/5ml OTC R E Registered by ADK
Company Pvt Ltd
1375 P2725 PARACETAMOL Setamol Hovid Bhd, Malaysia Tablet 500 mg OTC R E 05.03.2013 Registered by GKT
Pharmacy
1376 P1969 PARACETAMOL Ace Paediatric Square Pharmaceuticals, Oral Drops 80 mg/ ml OTC R E
Drop Bangladesh
1377 P2726 PARACETAMOL Parmol Hovid Bhd, Malaysia Oral Liquid 250mg/5ml OTC R E 05.03.2013 Registered by GKT
Pharmacy
1378 P2727 PARACETAMOL Parmol Hovid Bhd, Malaysia Oral Liquid 120mg/5ml OTC R E 05.03.2013 Registered by GKT
Pharmacy
1379 P1846 PARACETAMOL Hoemal HOE Pharmaceutical Oral Liquid 125mg/5ml OTC R E
Manufacturing (M) Sdn. Bhd.,
Malaysia
1380 P2021 PARACETAMOL Atp General Pharmacueticals Tablet 500 mg OTC R E
Ltd,Bangladesh
1381 P1818 PARACETAMOL Kaldol Cipla India Tablet 500mg OTC R E
1382 P2020 PARACETAMOL Atp General Pharmacueticals Ltd, Oral Liquid 120 mg/5 ml OTC R E
Bangladesh
1383 P1966 PARACETAMOL ACE 250 Square Pharmaceuticals, Suppository 250 mg OTC R E
Bangladesh
1384 P1973 PARACETAMOL Ace 125 Square Pharmaceuticals, Suppository 125 mg OTC R E
Bangladesh
1385 P1952 PARACETAMOL Paracetol Oral Gamma Pharmacueticals Pvt Oral Liquid 120 mg / 5 ml Oral liquid OTC R E
liquid Ltd, SriLanka
1386 P2379 PARACETAMOL Lanol 500 Lyka BDR India Tablet 500 mg OTC R E 25.07.2010 Registered by ADK
Company Pvt Ltd
1387 P3756 PARACETAMOL Reset Incepta pharmaceuticals Tablet 500 mg OTC Re E 06.09.2016 - Market Exclusivity
Limited, Bangladesh 05.09.2021 given to Dial Trade
and Travels Pte. Ltd.
1388 P3953 PARACETAMOL Axcel Paracetamol- Kotra Pharma (M) Sdn. Bhd., Suspension 250 mg / 5ml OTC Re E 06.12.2016- Market Exclusivity
250 1, 2, & 3 Jalan TTC 12, Cheng (Strawberry 05.12.2021 given to State Trading
Industrial Estate, 75250 Flavor) Organization Plc.
Melaka, Malaysia

1389 P4289 PARACETAMOL PARACIL SM Phamaceuticals SDN BHD Tablet 500mg OTC Re E 17.04.2018 - Market Exclusivity
(218620-M) Lot 88, Sungai 16.04.2023 given to Green
Petani, Industrial Estate, Pharmacy Godown
08000 Sungai Petani, Kedah,
Malaysia

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 85 of 113 Authorized by:DG,MFDA
 1390 P4290 PARACETAMOL PARACIL SM Phamaceuticals SDN BHD Oral Suspension 120mg/5ml OTC Re E 17.04.2018 - Market Exclusivity
(218620-M) Lot 88, Sungai 16.04.2023 given to Green
Petani, Industrial Estate, Pharmacy Godown
08000 Sungai Petani, Kedah,
Malaysia
1391 P4291 PARACETAMOL PARACIL SM Phamaceuticals SDN BHD Oral Suspension 250mg/5ml OTC Re E 17.04.2018 - Market Exclusivity
(218620-M) Lot 88, Sungai 16.04.2023 given to Green
Petani, Industrial Estate, Pharmacy Godown
08000 Sungai Petani, Kedah,
Malaysia
1392 P4382 PARACETAMOL Axcel Paracetamol- Kotra Pharma (M) Sdn. Bhd., Tablet 500mg OTC Re E 23.10.2018 - Market Exclusivity
500 1, 2 & 3, Jalan TTC 12, Cheng 22.10.2023 given to State Trading
Industrial Estate, 75250 Organization Plc
Melaka, Malaysia

1393 P4383 PARACETAMOL AxPain Kotra Pharma (M) Sdn. Bhd., Caplet 650mg OTC Re E 23.10.2018 - Market Exclusivity
1, 2 & 3, Jalan TTC 12, Cheng 22.10.2023 given to State Trading
Industrial Estate, 75250 Organization Plc
Melaka, Malaysia

1394 P1788 PARACETAMOL Progesic Xepa Soul Pattinson Tablet 500 mg OTC Re E 19.03.2019 - Market Exclusivity
(Malaysia) SDN. BHD. 1-5 18.03.2024 given ADK
Cheng Industrial Estate, 75250 Pharmaceutical
Melaka, Malaysia Company Pvt. Ltd.
1395 P3495 PARACETAMOL + PAMABROM Uphamol Upha Pharmaceutical Tablet 500 mg + 25 mg POM Re 19.05.2015- Market Exclusivity
Menstrual Tablet Manufacturing (M) Sdn. Bhd., 18.05.2020 given to Dial Trade
Malaysia and Travels Pte. Ltd.
1396 P2796 PARACETAMOL BP Dolo 650 Micro Labs ltd Tablet 650 mg OTC R E 30.07.2013 Registered by ADK
Company Pvt Ltd
1397 P2170 PARACETAMOL BP Medomol 650 Medopharm, India Tablet 650 mg OTC R E Registered by Green
Pharmacy
1398 P1852 PARACETAMOL BP Paracetol Interpharm Private Limited, Tablet 500mg OTC R E
Sri Lanka
1399 P1798 PARACETAMOL BP Rapisol Astron Limited, Sri Lanka Tablet 500mg OTC R E
1400 P3750 PARACETAMOL BP Axcel Paracetamol Kotra Pharma, Malaysia Suspension 250 mg/5 ml OTC Re E 30.08.2016 - Market Exclusivity
(Orange Flavor) 29.08.2021 given to State Trading
Organization Plc.

1401 P3603 PARACETAMOL BP PM 500 Aeon Formulations Pvt. Ltd., Uncoated Tablet 500 mg OTC Re E 20.10.2015 - Market Exclusivity
India 19.10.2020 given to Moonima
Medicals
1402 P3604 PARACETAMOL BP PM 650 Aeon Formulations Pvt. Ltd., Uncoated Tablet 650 mg OTC Re E 20.10.2015 - Market Exclusivity
India 19.10.2020 given to Moonima
Medicals
1403 P4331 PARACETAMOL BP Axcel Paracetamol- Kotra Pharma (M) Sdn. Bhd., Syrup 120mg/5ml (60ml) OTC Re E 02.10.2018 - Market Exclusivity
120 (Cherry) 1, Jalan TTC 12, Cheng 01.10.2023 given to State Trading
Industrial Estate, 75250, Organization Plc.
Malaka, Malaysia

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 86 of 113 Authorized by:DG,MFDA
 1404 P4431 PARACETAMOL BP Dolo Micro Lab Limite, 92, Sipcot Tablet 500mg OTC Re E 19.03.2019 - Market Exclusivity
Industrial Complex, Hosur-635 18.03.2024 given to ADK
126, India Pharmaceuticals
Company Pvt. Ltd.
1405 P1809 PARAVASTATIN Pravachol Bristol Myers Squibb Pakistan Tablet 20mg POM R

1406 P4159 PEPSIN IP , PAPAIN IP, SODIUM CITRATE, Xymex Drops Medley Ltd, India. Drop Oral 1:3000 + 10mg + 6 mg+40 mg+ OTC R Registered by ADK
CITRIC ACID MONOHYDRATE, GINGER OIL 8mg + 0.0012 ml + 0.0012 Company Pvt Ltd
,CINNAMON OIL ml/ml
1407 P4160 PEPSIN + FUNGAL DIATASE+THIAMINE HCL+ Xymex Syrup Medley Pharmaceuticals, syrup 20 mg + 40 mg + 2.5 mg +2.5 OTC R Registered by ADK
ROBOFLAVIN+ VITAMIN B6+ India mg + 1 mg + 2.5 mg + 23 mg Company Pvt Ltd
DEXPANTHENOL + NIACINAMIDE /10 ml
1408 P4161 PEPSIN + FUNGAL DIATASE+THIAMINE HCL+ Xymex MPS Medley Pharmaceuticals, Tablet 20 mg BP +) 40 mg + 2.5 mg + OTC R Registered by ADK
ROBOFLAVIN+ VITAMIN B6+ India 2.5 mg + 1 mg, 2.5 mg+ 23 mg Company Pvt Ltd
DEXPANTHENOL + NIACINAMIDE
1409 P3555 PERMETHRIN Glenper Glenmark Pharmaceuticals Cream 5% w/w OTC Re 25.08.2015- Market Exclusivity
Ltd. At: Plot No. E-37, 39, 24.08.2020 given to ADK Company
MIDC Area, Satpur, Nasik - Pvt. Ltd.
422 007, Maharashtra, India

1410 P2761 PETHIDINE Pethidine Neon Laboratories, India Injection 50 mg/ml INTERNATIONALLY R 08.05.2013 Registerd by State
CONTROLLED Trading Organization
(NARCORTIC) Plc.
1411 P2151 Phenoxymethyl Penicillin BP Arpecillin 250 Arvind Remedies Ltd, India Tablet 250 mg POM R E

1412 P4336 PHOLCODINE Axcel Iridin Linctus Kotra Pharma (M) Sdn. Bhd., Syrup 10mg/5ml NATIONALLY Re 02.10.2018 - Market Exclusivity
1, 2 & 3 Jalan TTC 12, Cheng CONTROLLED 01.10.2023 given to State Trading
Industrial Estate, 75250, (PSYCHOTROPIC) Organization Plc.
Malaka, Malaysia

1413 P1976 PIOGLITAZONE HYDROCHLORIDE Glito 15 Medley Ltd, India. Tablet 15 mg POM R
1414 P1975 PIOGLITAZONE HYDROCHLORIDE Glito 30 Medley Ltd, India. Tablet 30 mg POM R
1415 P3253 PIPERACILLIN + TAZOBACTAM USP PIPERACILLIN + Hovid Bhd, Malaysia Injection 4g + 0.5 g POM R 06.01.2015 Registered by GKT
TAZOBACTAM Pharmacy
1416 P3724 PIPERACILLIN USP + TAZOBACTAM USP Aristo Durataz 4.5 Aristo Pharmaceuticals Injection 4g + 0.5g POM Re 17.05.2016 - Market Exclusivity
Pvt.Ltd., India 16.05.2021 given to ADK
Pharmaceutical
Company Pvt. Ltd.
1417 P2180 PIPERRACILLIN+ TAZOBACTAM Zobactin 4.5 g Aurobindi Pharma Ltd,India Injection 4.5 g POM R

1418 P290 PIROXICAM Pirox Cipla India Gel 0.50% POM R 13.05.2010 Registered by ADK
Company Pvt Ltd
1419 P2853 PIROXICAM Flexicam 20 Hovid Bhd, Malaysia Capsule 20 mg POM R 07.11.2013 Registered by GKT
Pharmacy

1420 P1848 PIROXICAM + METHYL PARABEN + PROPYL Rhumagel HOE Pharmaceutical Gel 0.5% + 0.1% + 0.05% POM R
PARABEN Manufacturing (M) Sdn. Bhd.,
Malaysia

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 87 of 113 Authorized by:DG,MFDA
 1421 P225 PIROXICAM BETA CYCLODEXTRIN Brexin Chiesi Farmaceutici SPA Italy Tablet 20mg POM R

1422 P2486 PIROXICAM BP Medicam DT MMC Health Care Ltd,India Tablet 20 mg POM R 23.02.2011 Registered by Green
Pharmacy
1423 P2653 PNEUMOCOCCAL VACCINE Synflorix GlaxoSmithKline, Belgium Vaccine 0.5 ml contains 1 mcg of POM R 27.11.2012 Registered by ADK
saccharide of Serotypes Company Pvt Ltd
1,5,6B,7 F,9V, 14 and 23F and
3mcg of Serotypes4,18C and
19 F
1424 P2029 POLYETHYLENE GLYCOL + PROPYLENE Systane Alcon Eye Drops 0.4%+ 0.3% POM R
GLYCOL
1425 P3505 POLYETHYLENE GLYCOL + PROPYLENE Systear Aristo Pharma Limited, Eye Drops 0.4% + 0.3% POM Re 19.05.2015- Market Exclusivity
GLYCOL Bangladesh 18.05.2020 given to Life Support
Pvt. Ltd.
1426 P4294 Polymycin B Sulphate + Oxytetracycline HCl Polytet SM Pharmaceuticals Sdn. Bhd. Eye Ointment 6000 units + 5mg (3.5gm in a POM Re 15.05.2018 - Market Exclusivity
(218620-M) Lot 88, Sungai tube) 14.05.2023 given to Green
Petani, Industrial Estate, Pharmacy Godown
08000 Sungai Petani, Kedah,
Malaysia
1427 P2038 POLYMYXIN B SULFATE + NEOMYCIN Maxisporin Ashford Laboratories Ltd Eye Drops POM R
SULPHATE + DEXAMETHASONE
1428 P1725 POVIDONE IODINE Betadine Win Medicare, India Vaginal Pessaries 200 mg POM Re E 17.05.2016- Market Exclusivity
16.05.2021 given to AMDC Pvt.
Ltd.
1429 P1910 POVIDONE IODINE USP Steridine ointment Sterling Lab, India Ointment 5% w/w OTC R E Registered by AMDC
Pvt Ltd
1430 P1847 POVIDONE IODINE USP Poviderm HOE Pharmaceutical Ointment 10% w/w OTC R E
ointment Manufacturing (M) Sdn. Bhd.,
Malaysia
1431 P1724 POVIDONE IODINE USP (Povidone-iodine Betadine Ointment G.S Pharmbutor Pvt Ltd, B- Topical Ointment 10% w/w OTC Re E 01.03.2016- Market Exclusivity
IP) 172, Industrial Area, Behror- 28.02.2021 given to AMDC Pvt.
301701, Rajasthan, India Ltd.

1432 P3266 POVIDONE IODINE BP + METRONIDAZOLE Drez Stedman Pharmaceuticals, Ointment 5%w/w + 1% w/w POM R 06.01.2015 Registered by AMDC
BP India Pvt Ltd
1433 P2048 PREDNISOLONE Emsolone Medopharm, India Tablet 5 mg POM R Registered by Green
Pharmacy
1434 P2782 PREDNISOLONE Prednisolone Hovid Bhd, Malaysia Tablet 5 mg POM R 05.06.2013 Registered by GKT
Pharmacy
1435 P2919 PREDNISOLONE Zoralone HOE Pharmaceutical Oral Liquid 3mg/5ml POM R E 18.03.2014 Registered by Dial
Manufacturing (M) Sdn. Bhd., Trade and Travels Pte.
Malaysia Ltd.
1436 P3933 PREDNISOLONE Prednisolone Y.S.P. Industries (M) Sdn. Bhd. Syrup 3mg /5ml (60ml bottle) POM Re 01.11.2016 - Market Exclusivity
Lot 3, 5 & 7, Jalan P/7, Section 31.10.2021 given to Treetop
13, Kawasan Perindustrian Health Pvt. Ltd.
Bandar Baru bangi, 43000
Kajang, Selangor Darul Ehsan,
Malaysia

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 88 of 113 Authorized by:DG,MFDA
 1437 P1792 PREDNISOLONE ACETATE Econopred Plus 1% Alcon Laboratories Inc Eye Drops 1% w/v POM R E
Sterile Opthalmic
Suspension

1438 P3647 PREDNISOLONE ACETATE USP Mildopred Remington Pharmaceutical Ophthalmic 0.12% POM Re 21.01.2016 - Market Exclusivity
Industries Pvt. Ltd., 18 Km Suspension 20.01.2021 given to ADK Company
Multan Road, Lahore, Pvt. Ltd.
Pakistan

1439 P4072 PREDNISOLONE ACETATE USP Fortipred Remington Pharmaceutical Sterile Ophthalmic 1% (10 mg) POM Re 03.10.2017 - Market Exclusivity
Industries (Pvt) Ltd, 18km Suspension 02.10.2022 given to ADK
Multan Road, Lahore, Pharmaceutical
Pakistan Company Pvt. Ltd.

1440 P2755 PREGABALIN Gablin CCL Pharmaceuticals (Pvt.) Capsule 75 mg POM R 08.05.2013 Registered by ADK
Ltd. 62-Industrial Estate, Kot Company Pvt Ltd
Lakhpat, Lahore - Pakistan.

1441 P2756 PREGABALIN Gablin CCL Pharmaceuticals (Pvt.) Capsule 150 mg POM R 08.05.2013 Registered by ADK
Ltd. 62-Industrial Estate, Kot Company Pvt Ltd
Lakhpat, Lahore - Pakistan.

1442 P3518 PREGABALIN Gabalin -75 Atoz Pharmaceuticals, India Capsule 75 mg POM Re 19.05.2015- Market Exclusivity
18.05.2020 given to My Chemist
Wholesale
1443 P3760 PREGABALIN INN Neurolin 50 Square Pharmaceuticals Ltd., Capsule 50 mg POM Re 06.09.2016 - Market Exclusivity
Bangladesh 05.09.2021 given to Dial Trade
and Travels Pte. Ltd.
1444 P3807 PREGABALIN INN Neurolin 75 Square Pharmaceuticals Ltd., Capsule 75mg POM Re 11.10.2016- Market Exclusivity
Pabna Unit, Salgaria, Pabna, 10.10.2021 given to Dial Trade
Bangladesh and Travels Pte. Ltd.

1445 P2570 PROCHLORPERAZINE Stemetil Sanofi Bangladesh Ltd Tablet 5 mg POM R 31.01.2012 Registered by ADK
Company Pvt Ltd
1446 P2569 PROCHLORPERAZINE MALEATE Stemetil Nitin Life Sciences Ltd, Unit-III, Injection 12.5 mg/ml POM R 31.01.2012 Registered by ADK
India Company Pvt Ltd
1447 P2571 PROMETHAZINE Avomine Sanofi Bangladesh Ltd Tablet 25 mg OTC R E 31.01.2012 Registered by ADK
Company Pvt Ltd
1448 P2144 PROMETHAZINE BP Arphen 10 Arvind Remedies Ltd, India Tablet 10 mg OTC R E

1449 P3570 PROMETHAZINE HCL BP Promethazine Upha Pharmaceutical Oral Suspension 5mg/5 ml POM Re 08.09.2015 - Market Exclusivity
Manufacturing (M) Sdn. Bhd. 07.09.2020 given to Dial Trade
Lot 2 & 4, Jalan P/7, Seksyen and Travels Pte. Ltd.
13, Kawasan Perusahaan
Bangi, 43650 Bandar Baru
Bangi, Selangor Darul Ehsan,
Malaysia

1450 P2042 PROPARACAINE USP Primax Ashford Laboratories Ltd Eye Drops 5mg POM R

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 89 of 113 Authorized by:DG,MFDA
 1451 P2779 PROPOFOL Neorof Neon Laboratories, India Injection 1% Restricted for R E 05.06.2013 Registerd by State
Hospital use only Trading Organization
Plc.
1452 P4002 PROPOFOL Fresofol 1% Fresenius Kabi Austria GmbH Emulsion for 10mg/ml (1%) Restricted for Re 15.08.2017 - Market Exclusivity
MCT/LCT Fresenius (HafnerstraBe 36), A-8055 injection or Hospital use only 14.08.2022 given to State Trading
Graz, Austria Infusion Organization Plc.
(ampoules)
1453 P4433 PROPOFOL BP Troypofol Troikaa Pharmaceuticals Emulsion for 10mg/ml (1% w/v) (20ml vial) POM Re E 19.03.2019 - Market Exclusivity
Limited, C-1 Sara Industrial injection or 18.03.2024 given to ADK
Estate, Selaqui, Dehradun-248 Infusion Pharmaceuticals
197, Uttarakhand, India Company Pvt. Ltd.

1454 P2283 PYRANTEL PAMOATE Pyrentel Astron Limited, Sri Lanka Tablet 125 mg OTC R Registered by ADK
Company Pvt Ltd
1455 P2157 PYRIDOXINE HYDROCHLORIDE IP + Cobadex CZS Remedix Pharma Pvt Tablet 3 mg+100 mg+15 mcg+1500 POM R
NICOTINAMIDE IP + CYNACOBALAMIN IP + Ltd/GSK,India mcg
FOLIC ACID IP
1456 P3146 RABEPRAZOLE SODIUM Rabitone - 20 Cassel Research Laboratories, Tablet 20 mg POM R E 19.08.2014 Registered by My
India Chemist Wholesale

1457 P1938 RABEPRAZOLE SODIUM Repraz 20 Medley Ltd, India. Tablet 20 mg POM R
1458 P1939 RABEPRAZOLE SODIUM Repraz10 Medley Ltd, India. Tablet 10 mg POM R
1459 P3533 RABEPRAZOLE SODIUM Rabocia 20 Atoz Pharmaceuticals, India Tablet 20 mg POM Re 19.05.2015- Market Exclusivity
18.05.2020 given to My Chemist
Wholesale
1460 P2329 RAMIPRIL Cardace Sanofi India Ltd Tablet 10 mg POM R 31.03.2010 Registered by ADK
Company Pvt Ltd
1461 P2326 RAMIPRIL Cardace Sanofi India Ltd Tablet 1.25 mg POM R
1462 P2327 RAMIPRIL Cardace Sanofi India Ltd Tablet 2.5 mg POM R
1463 P2328 RAMIPRIL Cardace Sanofi India Ltd Tablet 5 mg POM R
1464 P3545 RANIBIZUMAB Lucentis Novartis Pharma AG, Injection 10 mg/ml POM Re 30.06.2015 - Market Exclusivity
Switzerland 29.06.2020 given to Mediquip
Maldives Pvt. Ltd.
1465 P1658 RANITIDINE Rantac Unique, India/ JB Chemicals Injection 25mg/ml POM R E Registered by ADK
Company Pvt Ltd
1466 P674 RANITIDINE Zantac GlaxoSmithKline, China Tablet 150 mg POM R E 28.02.2010 Registered by ADK
Company Pvt Ltd
1467 P1657 RANITIDINE Rantac Unique, India/ JB Chemicals Tablet 150mg POM R E Registered by ADK
Company Pvt Ltd
1468 P2009 RANITIDINE Neotack 150 Square Pharmaceuticals, Tablet 150 mg POM R E
Bangladesh
1469 P1911 RANITIDINE Rancer - 150 Sterling Lab, India Tablet 150mg POM R Registered by AMDC
Pvt Ltd
1470 P2705 RANITIDINE BP Ranitin Torrent Pharmaceuticals, Tablet 150 mg POM R E 19.02.2013 Registered by Life
India Support Pvt Ltd
1471 P1990 RANITIDINE USP Emtac 150 Medopharm, India Tablet 150 mg POM R E Registered by Green
Pharmacy
1472 P2620 RANITIDINE USP Zynol Micro Labs ltd Tablet 150 mg POM R 18.09.2012 Registered by ADK
Company Pvt Ltd

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 90 of 113 Authorized by:DG,MFDA
 1473 P3611 RANOLAZINE Cartinex - OD Micro Labs Limited, 92, Film coated 1000 mg POM R 25.05.2015 Registered
SIPCOT, HOSUR-635 126 INDIA Extended Release
Tablet
1474 P3612 RANOLAZINE Cartinex Micro Labs Limited, 92, Extended Release 500 mg POM R 25.05.2015 Registered
SIPCOT, HOSUR-635 126 INDIA Tablet

1475 P3159 RETAPAMULIN Altargro Glaxo , UK Ointment 1% POM R 19.08.2014 Registered by ADK
Company Pvt Ltd
1476 P1113 RINGER LACTATE Compound Sodium Marck Bio Sciences Ltd,India Injection 500ml POM R E Each Registered by ADK
Lactate IV Infusion Shipment Company Pvt Ltd
B.P. should be
accompanied
by the batch
certificates

1477 P120 RINGER LACTATE Compound Sodium Baxter Ltd, India. Injection 500ml POM R E Each Registered by ADK
Lactate IV Infusion Shipment Company Pvt Ltd
B.P. should be
accompanied
by the batch
certificates

1478 P3478 RISEDRRONATE SODIUM Azebone Pharmix Laboratories Pakistan Tablet 35 mg POM Re 21.04.2015 - Market Exclusivity
20.04.2020 given to Life Support
Pvt. Ltd.
1479 P3609 RIZATRIPTAN BENZOATE USP Rizamig-10 Micro Labs Limited, 92, Orodiapersible 10 mg POM R 25.05.2015 Registered
SIPCOT, HOSUR-635 126 INDIA Tablet

1480 P3610 RIZATRIPTAN BENZOATE USP Rizamig-5 Micro Labs Limited, 92, Orodiapersible 5mg POM R 25.05.2015 Registered
SIPCOT, HOSUR-635 126 INDIA Tablet

1481 P2878 ROSUVASTATIN Rosulip Cipla India Tablet 10 mg POM R 07.01.2014 Registered by ADK
Company Pvt Ltd
1482 P2879 ROSUVASTATIN Rosulip Cipla India Tablet 20 mg POM R 07.01.2014 Registered by ADK
Company Pvt Ltd
1483 P2752 ROSUVASTATIN Crestat 5 CCL Pharmaceuticals, Tablet 5 mg POM R 08.05.2013 Registered by ADK
Pakistan Company Pvt Ltd
1484 P2753 ROSUVASTATIN Crestat 10 CCL Pharmaceuticals, Tablet 10 mg POM R 08.05.2013 Registered by ADK
Pakistan Company Pvt Ltd
1485 P2754 ROSUVASTATIN Crestat 20 CCL Pharmaceuticals, Tablet 20 mg POM R 08.05.2013 Registered by ADK
Pakistan Company Pvt Ltd
1486 P3595 ROSUVASTATIN Rosvalip MMC Healthcare Ltd. India Film coated tablet 20 mg POM Re 27.10.2015- Market Exclusivity
26.10.2020 given to Green
Pharmacy Godown
1487 P3594 ROSUVASTATIN CALCIUM Rosvalip MMC Healthcare Ltd. India Film coated tablet 10 mg POM Re 27.10.2015- Market Exclusivity
26.10.2020 given to Green
Pharmacy Godown
1488 P3506 ROSUVASTATIN CALCIUM Rosvin-10 Medley Ltd, India. Tablet 10 mg IP POM Re 19.05.2015- Market Exclusivity
18.05.2020 given to ADK Company
Pvt. Ltd.

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 91 of 113 Authorized by:DG,MFDA
 1489 P3507 ROSUVASTATIN CALCIUM Rosvin-5 Medley Ltd, India. Tablet 5 mg IP POM Re 19.05.2015- Market Exclusivity
18.05.2020 given to ADK Company
Pvt. Ltd.
1490 P3616 ROSUVASTATIN CALCIUM X-Plended PharmEvo (Private) Limited, Film coated tablet 20 mg POM Re 17.11.2015- Market Exclusivity
At Plot # A-29, Northe 16.11.2020 given to Life Support
Western Industrial Zone, Port Pvt. Ltd.
Qasim, Karachi, Karachi-
75020, Pakistan

1491 P3617 ROSUVASTATIN CALCIUM X-Plended PharmEvo (Private) Limited, Film coated tablet 10 mg POM Re 17.11.2015- Market Exclusivity
At Plot # A-29, Northe 16.11.2020 given to Life Support
Western Industrial Zone, Port Pvt. Ltd.
Qasim, Karachi, Karachi-
75020, Pakistan

1492 P3618 ROSUVASTATIN CALCIUM X-Plended PharmEvo (Private) Limited, Film coated tablet 5 mg POM Re 17.11.2015- Market Exclusivity
At Plot # A-29, Northe 16.11.2020 given to Life Support
Western Industrial Zone, Port Pvt. Ltd.
Qasim, Karachi, Karachi-
75020, Pakistan

1493 P3258 ROSUVASTATIN IP Rosutec Hetro Labs Limited, India Tablet 10 mg POM R 06.01.2015 Registerd by State
Trading Organization
Plc.
1494 P2236 ROTAVIRUS Rotarix Oral Glaxo Smithkline Biologicals Vaccine 10 CDLD 50/ml POM R Registered by ADK
Vaccine Company Pvt Ltd
1495 P2422 ROXITHROMYCIN Roxem Aristo India Tablet 150 mg POM R 25.10.2010 Registered by ADK
Company Pvt Ltd
1496 P2286 ROXITHROMYCIN Hycin Saga Laboratories, India Tablet 150mg POM R Registered by Dial
Trade and Travels Pte.
Ltd.
1497 P37 ROXITHROMYCIN Roxid Drops Alembic Pharmaceuticals Oral Liquid 50mg/10ml POM R Registered by Dial
Limited India Trade and Travels Pte.
Ltd.
1498 P36 ROXITHROMYCIN Roxid Alembic Pharmaceuticals Tablet 150mg POM R Registered by Dial
Limited India Trade and Travels Pte.
Ltd.
1499 P38 ROXITHROMYCIN Roxid Kid Alembic Pharmaceuticals Tablet 50mg POM R Registered by Dial
Limited India Trade and Travels Pte.
Ltd.
1500 P39 ROXITHROMYCIN Roxid Liquid Alembic Pharmaceuticals Oral Liquid 50mg/30ml POM R Registered by Dial
Limited India Trade and Travels Pte.
Ltd.
1501 P1992 ROXITHROMYCIN Medirox Medopharm, India Tablet 150 mg POM R Registered by Green
Pharmacy
1502 P1912 ROXITHROMYCIN Roxter - 150 Sterling Lab, India Tablet 150mg POM R Registered by AMDC
Pvt Ltd
1503 P2424 S (-) AMLODIPINE S-Amlosafe 5 Aristo India Tablet 5 mg POM R 25.10.2010 Registered by ADK
Company Pvt Ltd

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 92 of 113 Authorized by:DG,MFDA
 1504 P4286 SACUBITRIL + VALSARTAN Entresto 50 Novartis Pharma Stein AG, Film coated tablet 50mg (24.3mg + 25.7g) POM Re 17.04.2018 - Market Exclusivity
Stein, Switzerland 16.04.2023 given to Mediquip
Maldives Pvt. Ltd.
1505 P4287 SACUBITRIL + VALSARTAN Entresto 100 Novartis Pharma Stein AG, Film coated tablet 100mg (48.6mg + 54.1mg) POM Re 17.04.2018 - Market Exclusivity
Stein, Switzerland 16.04.2023 given to Mediquip
Maldives Pvt. Ltd.
1506 P4288 SACUBITRIL + VALSARTAN Entresto 200 Novartis Pharma Stein AG, Film coated tablet 200mg (97.2mg + 102.8mg) POM Re 17.04.2018 - Market Exclusivity
Stein, Switzerland 16.04.2023 given to Mediquip
Maldives Pvt. Ltd.
1507 P3212 SALBUTAMOL Ventamol Oral Hovid Bhd, Malaysia Oral Liquid 2 mg/5ml ( BP) POM R 06.11.2014 Registered by GKT
liquid Pharmacy
1508 P2512 SALBUTAMOL Cybutol 200 Pharmachemie BV, The Inhalation Capsule 200mcg POM R 25.05.2011 Registered by ADK
Netherland Company Pvt Ltd
1509 P2511 SALBUTAMOL Cybutol 400 Pharmachemie BV, The Inhalation Capsule 400mcg POM R 25.05.2011 Registered by ADK
Netherland Company Pvt Ltd
1510 P3166 SALBUTAMOL Asthalin DP Cipla India Inhalation Capsule 400 mcg POM R 16.09.2014 Registered by ADK
Company Pvt Ltd
1511 P741 SALBUTAMOL Ventolin GlaxoSmithKline, SriLanka Oral Liquid 2 mg/ 5ml POM R E 21.03.2010 Registered by ADK
Company Pvt Ltd
1512 P298 SALBUTAMOL Asthalin Cipla India Inhaler 100 mcg/md POM R E 13.07.2009 Registered by ADK
Company Pvt Ltd
1513 P302 SALBUTAMOL Asthalin Resp Cipla India Nebulising 5mg POM R E Registered by ADK
solution Solution Company Pvt Ltd
1514 P300 SALBUTAMOL Asthalin Cipla India Oral Liquid 2 mg /5 ml POM R E 17.12.2009 Registered by ADK
Company Pvt Ltd
1515 P676 SALBUTAMOL Ventolin GlaxoSmithKline, Bangladesh Tablet 2 mg POM R E 10.09.13 Registerd by State
Trading Organization
Plc.
1516 P226 SALBUTAMOL Butovent Spray Chiesi Farmaceutici SPA Italy Inhaler 100mcg/metered dose POM R E

1517 P693 SALBUTAMOL Ventolin Evohaler Glaxo Wellcome Aerosol 100 mcg/md in 200md POM R E 01.11.2010 Registered by ADK
Australia/Spain Company Pvt Ltd
1518 P1953 SALBUTAMOL Salbutamol Gamma Pharmacueticals Pvt Oral Liquid 2 mg / 5 ml POM R E
Ltd, SriLanka
1519 P3206 SALBUTAMOL + GUAPHENESIN Ventamol Hovid Bhd, Malaysia Oral Liquid 1.2 mg + 50 mg in 5ml POM R E 06.11.2014 Registered by GKT
Expectorant Pharmacy
1520 P4273 SALBUTAMOL SULPHATE Breathnine SM Phamaceuticals SDN BHD Syrup 2mg/5ml POM Re 17.04.2018 - Market Exclusivity
(218620-M) Lot 88, Sungai 16.04.2023 given to Green
Petani, Industrial Estate, Pharmacy Godown
08000 Sungai Petani, Kedah,
Malaysia
1521 P4334 SALBUTAMOL SULPHATE Axcel Salbutamol Kotra Pharma (M) Sdn. Bhd., Syrup 2mg/5ml POM Re E 02.10.2018 - Market Exclusivity
1, 2 & 3 Jalan TTC 12, Cheng 01.10.2023 given to State Trading
Industrial Estate, 75250, Organization Plc.
Malaka, Malaysia

1522 P3153 SALBUTAMOL SULPHATE BP + BROMHEXINE Ascoril Glenmark , India Tablet 2 mg+ 8mg+ 100 mg POM R 19.08.2014 Registered by ADK
HCL BP + GUAIFENESIN USP Company Pvt Ltd

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 93 of 113 Authorized by:DG,MFDA
 1523 P2259 SALBUTAMOL SULPHATE BP + BROMHEXINE Ascoril Glenmark Pharmaceuticals Oral Liquid 2 mg+4 mg +100 mg + 1mg POM Re 14.03.2017 - Market Exclusivity
HYDROCHLORIDE BP +GUAIFENESIN USP + Expectorant Ltd., At:Village: Kishanpura, /10ml 14.03.2022 given to ADK
MENTHOL BP Baddi-Nalagarh Road, Tehsil Pharmaceutical
Baddi, Distt. Solan, (H.P.) - 173 Company Pvt. Ltd.
205, India

1524 P2873 SALFASALAZINE Sazo EN 500 Wallace Pharmaceuticals, Tablet (Delayed 500 mg POM R 07.01.2014 Registered by AMDC
India Release) Pvt Ltd

1525 P2863 SALICYLIC ACID Ellgy Solution HOE Pharmaceutical Topical Solution 17% w/v POM R 07.11.2013 Registered by Dial
Manufacturing (M) Sdn. Bhd., Trade and Travels Pte.
Malaysia Ltd.
1526 P303 SALMETEROL Serobid Cipla India Aerosol 25 mcg/md POM R E 13.05.10 Registered by ADK
Company Pvt Ltd
1527 P1820 SALMETEROL + FLUTICASONE Seroflo-125 Cipla India Inhaler 25mcg/puff + 25 mcg/puff POM R
1528 P1821 SALMETEROL + FLUTICASONE Seroflo-250 Cipla India Inhaler 25mcg/puff +250 mcg/puff POM R
1529 P1819 SALMETEROL + FLUTICASONE Seroflo-50 Cipla India Inhaler 25mcg/puff + 50 mcg/puff POM R
1530 P3163 SALMETEROL + FLUTICASONE BP Seroflo 100 Cipla India Inhalation Capsule 50 mcg + 100 mcg POM R 16.09.2014 Registered by ADK
Company Pvt Ltd
1531 P3164 SALMETEROL + FLUTICASONE BP Seroflo 250 Cipla India Inhalation Capsule 50 mcg + 250 mcg POM R 16.09.2014 Registered by ADK
Company Pvt Ltd
1532 P3165 SALMETEROL + FLUTICASONE BP Seroflo 500 Cipla India Inhalation Capsule 50 mcg + 500 mcg POM R 16.09.2014 Registered by ADK
Company Pvt Ltd
1533 P1826 SALMETEROL + FLUTICASONE PROPIONATE Seretide Glaxo Wellcome Production - Accuhaler 50mcg + 100mcg /puff POM R
Accuhaler™ / Evreux, France
Diskus™ 100
1534 P1827 SALMETEROL + FLUTICASONE PROPIONATE Seretide Glaxo Wellcome Production - Accuhaler 50mcg + 250mcg /puff POM R
Accuhaler™ / Evreux, France
Diskus™ 250
1535 P1828 SALMETEROL + FLUTICASONE PROPIONATE Seretide Glaxo Wellcome Production - Accuhaler 50mcg + 500mcg /puff POM R
Accuhaler™ / Evreux, France
Diskus™ 500
1536 P3651 SALMETEROL + FLUTICASONE PROPIONATE Combiwave SF 125 Glenmark Pharmaceuticals Inhaler 25+125 mcg/Actuation POM Re 21.01.2016 - Market Exclusivity
Ltd., At:Village: Kishanpura, 20.01.2021 given to ADK Company
Baddi-Nalagarh Road, Tehsil Pvt. Ltd.
Baddi, Distt. Solan, (H.P.) - 173
205, India

1537 P3652 SALMETEROL + FLUTICASONE PROPIONATE Combiwave SF 250 Glenmark Pharmaceuticals Inhaler 25+250 mcg/ Actuation POM Re 21.01.2016 - Market Exclusivity
Ltd., At:Village: Kishanpura, 20.01.2021 given to ADK Company
Baddi-Nalagarh Road, Tehsil Pvt. Ltd.
Baddi, Distt. Solan, (H.P.) - 173
205, India

MTG Division, MFDA Rec. Name: Approved Drug List

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Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 94 of 113 Authorized by:DG,MFDA
 1538 P4001 SALMETEROL XINAFOATE BP + Combiwave SF 50 Glenmark Pharmaceuticals Inhaler 25mcg + 50mcg (120 Metered POM Re 15.08.2017 - Market Exclusivity
FLUTICASONE PROPIONATE BP Ltd., At:Village: Kishanpura, Doses) 14.08.2022 given to ADK
Baddi-Nalagarh Road, Tehsil Pharmaceutical
Baddi, Distt. Solan, (H.P.) - 173 Company Pvt. Ltd.
205, India

1539 P2030 FLUTICASONE PROPIONATE + SALMETEROL Seretide Glaxo Wellcome Production, Evohaler 50mcg/25mcg per dose POM R
(as xinafoate) Zone Inductrielle n°2, 23, Rue (120 metered actuations)
Lavoiser, Evreux Cedex -
France

1540 P2031 FLUTICASONE PROPIONATE + SALMETEROL Seretide Glaxo Wellcome Production, Evohaler 125mcg/25mcg per dose POM R
(as xinafoate) Zone Inductrielle n°2, 23, Rue (120 metered actuations)
Lavoiser, Evreux Cedex -
France

1541 P2032 FLUTICASONE PROPIONATE + SALMETEROL Seretide Glaxo Wellcome Production, Evohaler 250mcg/25mcg per dose POM R
(as xinafoate) Zone Inductrielle n°2, 23, Rue (120 metered actuations)
Lavoiser, Evreux Cedex -
France

1542 P2140 SALMON CALCITONIN Miacalcic Nasal Delpharm Huningue SAS, Nasal Spray 200 IU POM R
Spray France
1543 P3752 SECUKINUMAB Cosentyx Novartis Pharma Stein AG, Pre-filled Syringe 150 mg/ml POM Re 23.08.2016 - Market Exclusivity
Switzerland 22.08.2021 given to Mediquip
Maldives Pvt. Ltd.
1544 P2420 SERRATIOPEPTIDASE Tolpa Micro Labs ltd Tablet 10 mg POM R 06.10.2010 Registered by ADK
Company Pvt Ltd
1545 P3178 SERTACONAZOLE NITRATE BP Onabet Glenmark Pharmaceuticals Cream 2% w/w (20mg/g) POM Re 25.08.2015- Market Exclusivity
Ltd. Plot No. E-37, 39, MIDC 24.08.2020 given to ADK Company
Area, Satpur, Nasik - 422 007, Pvt. Ltd.
Maharashtra, India

1546 P2791 SETRALINE HCL Trinin Pharmix Laboratories, Tablet 50 mg POM R 05.06.2013 Registered by Life
Pakistan Support Pvt Ltd
1547 P3204 SILDENAFIL Vigorex Square Pharmaceuticals, Tablet 50 mg POM R 06.11.2014 Registered by Dial
Bangladesh Trade and Travels Pte.
Ltd.
1548 P2539 SILDENAFIL Kamagra Ajanta Pharma Ltd, India Tablet 100 mg POM R 15.12.2012 Registered by ADK
Company Pvt Ltd
1549 P2538 SILDENAFIL Kamagra Ajanta Pharma Ltd, India Tablet 50 mg POM R 15.12.2012 Registered by ADK
Company Pvt Ltd
1550 P2912 SILDENAFIL Novagra Forte Micro Labs ltd Capsule 100 mg POM R 18.03.2014 Registered by ADK
Company Pvt Ltd
1551 P305 SILDENAFIL Silagra Cipla India Tablet 100mg POM R E 17.12.2009 Registered by ADK
Company Pvt Ltd
1552 P307 SILDENAFIL Silagra Cipla India Tablet 50mg POM R E 17.12.2009 Registered by ADK
Company Pvt Ltd

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 95 of 113 Authorized by:DG,MFDA
 1553 P2491 SILDENAFIL Charge 100 MMC Health Care Ltd, India Tablet 100 mg POM R 23.02.2011 Registered by Green
Pharmacy
1554 P2249 SILDENAFIL Novagra 50 Micro Labs ltd Tablet 50 mg POM R Registered by ADK
Company Pvt Ltd
1555 P2495 SILVER SULPHADIAZINE USP Bactin Arvind Remedies Ltd, India Cream 1% w/w POM R 23.02.2011 Registered by Green
Pharmacy
1556 P1986 SIMVASTATIN Simvastin 10 Medopharm, India Tablet 10 mg POM R E Registered by Green
Pharmacy
1557 P1987 SIMVASTATIN Simvastin 20 Medopharm, India Tablet 20 mg POM R E Registered by Green
Pharmacy
1558 P2741 SIMVASTATIN Simvastatin Cresent Pharma,London Tablet 10 mg POM R 08.05.2013 Registered by Life
Support Pvt Ltd
1559 P2742 SIMVASTATIN Simvastatin Cresent Pharma,London Tablet 20 mg POM R 08.05.2013 Registered by Life
Support Pvt Ltd
1560 P3197 SIMVASTATIN Vascor HOE Pharmaceutical Tablet 20 mg POM R E 06.11.2014 Registered by Dial
Manufacturing (M) Sdn. Bhd., Trade and Travels Pte.
Malaysia Ltd.
1561 P1937 SIMVASTATIN Simvin 20 Medley Ltd, India. Tablet 20 mg POM R E
1562 P1872 SIMVASTATIN Simvin - 10 Medley Ltd, India. Tablet 10mg POM R E Registered by ADK
Company Pvt Ltd
1563 P1871 SIMVASTATIN Simvin - 5 Medley Ltd, India. Tablet 5mg POM R E Registered by ADK
Company Pvt Ltd
1564 P4065 SIMVASTATIN Pharmaniaga Pharmaniaga Manufacturing Film coated Tablet 10mg POM Re 03.10.2017 - Market Exclusivity
Simvastatin Berhad (60016-D) 11A Jalan 02.10.2022 given to Dial Trade
P/1, Kawasan Perusahan and Travels Pte. Ltd.
Bangi, 43650 Bandar Baru
Bangi, Selangor Darul Ehsan,
Malaysia

1565 P3105 SIMVASTATIN USP Stavid Hovid Bhd, Malaysia Tablet 20mg POM R 20.05.2014 Registered by GKT
Pharmacy
1566 P2190 SIMVASTATIN USP Simvas 10 Micro Labs ltd Tablet 10 mg POM R E Registered by ADK
Company Pvt Ltd
1567 P2191 SIMVASTATIN USP Simvas 20 Micro Labs ltd Tablet 20 mg POM R E Registered by ADK
Company Pvt Ltd
1568 P2659 SITAGLIPTIN PHOSPHATE MONOHYDRATE Sita CCL Pharmaceuticals (Pvt.) Film coated tablet 50 mg POM R 27.11.2012 Registered by ADK
Ltd. 62-Industrial Estate, Kot Company Pvt Ltd
Lakhpat, Lahore - Pakistan.

1569 P2660 SITAGLIPTIN PHOSPHATE MONOHYDRATE Sita CCL Pharmaceuticals (Pvt.) Film coated tablet 100 mg POM R 27.11.2012 Registered by ADK
Ltd. 62-Industrial Estate, Kot Company Pvt Ltd
Lakhpat, Lahore - Pakistan.

1570 P3743 SITAGLIPTIN PHOSPHATE MONOHYDRATE Siglita 50 Square Pharmaceuticals Ltd., Film coated tablet 50 mg POM Re 30.08.2016 - Market Exclusivity
INN Pabna, Bangladesh 29.08.2021 given to Dial Trade
and Travels Pte. Ltd.
1571 P3744 SITAGLIPTIN PHOSPHATE MONOHYDRATE Siglita 100 Square Pharmaceuticals Ltd., Film coated tablet 100 mg POM Re 30.08.2016 - Market Exclusivity
INN Pabna, Bangladesh 29.08.2021 given to Dial Trade
and Travels Pte. Ltd.

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 96 of 113 Authorized by:DG,MFDA
 1572 P3984 SITAGLIPTIN PHOSPHATE MONOHYDRATE Swizglipt 50 Swiss Garnier Life Sciences, Film-coated tablet 50mg POM Re 20.06.2017 - Market Exclusivity
No:21-23 Industrial Area, 20.06.2022 given to AMDC Pvt.
Mehatpur, Dist UNA, Ltd.
Himachel Pradesh, 174315,
INDIA

1573 P3985 SITAGLIPTIN PHOSPHATE MONOHYDRATE Swizglipt 100 Swiss Garnier Life Sciences, Film-coated tablet 100mg POM Re 20.06.2017 - Market Exclusivity
No:21-23 Industrial Area, 20.06.2022 given to AMDC Pvt.
Mehatpur, Dist UNA, Ltd.
Himachel Pradesh, 174315,
INDIA

1574 P2828 SODIUM CHLORIDE Normal Saline Fresenius Kabi India Ltd,India Injection 1 % w/v in 100ml POM R E

1575 P552 SODIUM CHLORIDE Normal Saline Fresenius Kabi, India Injection 0.9%w/v in 500 ml POM R E

1576 P3548 SODIUM CHLORIDE BD PosiFlush Becton, Dickinson and Pre-Filled Syring 0.9% ( 10 ml) OTC Re 25.08.2015- Market Exclusivity
Company, Franklin Lakes, NJ 24.08.2020 given to Medlab
07417, USA Diagnostics
1577 P3549 SODIUM CHLORIDE BD PosiFlush Becton, Dickinson and Pre-Filled Syring 0.9% ( 5 ml) OTC Re 25.08.2015- Market Exclusivity
Company, Franklin Lakes, NJ 24.08.2020 given to Medlab
07417, USA Diagnostics
1578 P3550 SODIUM CHLORIDE BD PosiFlush Becton, Dickinson and Pre-Filled Syring 0.9% ( 3 ml) OTC Re 25.08.2015- Market Exclusivity
Company, Franklin Lakes, NJ 24.08.2020 given to Medlab
07417, USA Diagnostics
1579 P4415 SODIUM CHLORIDE B. Braun 0.9% NaCl B. Braun Medical Industries Intravenous 0.9% w/v (0.9g/100ml) in 10ml POM Re E 19.03.2019 - Market Exclusivity
S/B 11900 Bayan Lepas, solution for single dose container 18.03.2024 given to Medtech
Penang, Malaysia infusion Maldives Pvt. Ltd. only

1580 P4416 SODIUM CHLORIDE B. Braun 0.9% NaCl B. Braun Medical Industries Intravenous 0.9% w/v (0.9g/1000ml) in POM Re E 19.03.2019 - Market Exclusivity
S/B 11900 Bayan Lepas, solution for 100ml single dose container 18.03.2024 given to Medtech
Penang, Malaysia infusion Maldives Pvt. Ltd. only

1581 P4417 SODIUM CHLORIDE B. Braun 0.9% NaCl B. Braun Medical Industries Intravenous 0.9% w/v (0.9g/1000ml) in POM Re E 19.03.2019 - Market Exclusivity
S/B 11900 Bayan Lepas, solution for 500ml single dose container 18.03.2024 given to Medtech
Penang, Malaysia infusion Maldives Pvt. Ltd. only

1582 P4418 SODIUM CHLORIDE B. Braun 0.9% NaCl B. Braun Medical Industries Intravenous 0.9% w/v (0.9g/1000ml) in POM Re E 19.03.2019 - Market Exclusivity
S/B 11900 Bayan Lepas, solution for 1000ml single dose container 18.03.2024 given to Medtech
Penang, Malaysia infusion Maldives Pvt. Ltd. only

1583 P2108 Sodium Chloride Salacyn 5% Eye Ashford Laboratories Ltd Eye Drops 50 mg POM R
Drops
1584 P553 SODIUM CHLORIDE + DEXTROSE DNS (Dextrose Fresenius Kabi India Pvt. Injection 0.9%w/v + 5%w/v in 500 ml POM R E
Normal Saline) Limited

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 97 of 113 Authorized by:DG,MFDA
 1585 P3102 SODIUM CHLORIDE + POTASSIUM Walyte (ORS) Indi pHarma Pvt ltd for Powder for 2.6 g+1.5 g + 2.9g(IP)+13.5 g OTC R 20.05.2014 Registered by AMDC
CHLORIDE + SODIUM CITRATE + DEXTROSE Wallace Pharmaceuticals, solution per sachet Pvt Ltd
India
1586 P2522 SODIUM CHLORIDE + POTASSIUM Peditral Powder Searle, Pakistan Powder for Oral 2.60g+ 1.50 + 2.90g+ 13.50g OTC R 23.06.2011 Registered by ADK
CHLORIDE+TRICARBOXYLATE DIHYDRATE+ Solution per sachet Company Pvt Ltd
DEXTROSE
1587 P3134 SODIUM CHLORIDE BP Tonoflag Axa Parentrals limited Injection 0.9% w/v in 100ml POM R E 19.08.2014 Registered by Medlab
Diagnostics Pvt. Ltd.

1588 P121 SODIUM CHLORIDE BP Sodium Chloride IV Baxter Ltd, India. Injection 0.90% POM R E Registered by ADK
Infusion B. P. (0.9% Company Pvt Ltd
W/V)

1589 P3560 SODIUM CHLORIDE BP Hovid Cleaq Hovid Bhd, Malaysia Nasal Solution 0.65% POM Re 08.09.2015 - Market Exclusivity
07.09.2020 given to My Chemist
Wholesale
1590 P3137 SODIUM CHLORIDE BP + DEXTROSE BP Dexoship Axa Parentrals limited Injection 0.9% w/v + 5.0% w/v in 100ml POM R E 19.08.2014 Registered by Medlab
Diagnostics Pvt. Ltd.

1591 P3580 SODIUM CHLORIDE USP Nasi-Saline Merck Limited, Shiv Sagar Nasal Drops 0.65% w/v in 10 ml OTC Re E 06.10.2015- Market Exclusivity
Estate 'A', Dr. Annie Besant 05.10.2020 given to State Trading
Road, Worli, Mumbai - 400 Organization Plc.
018, India
1592 P869 SODIUM FUSIDATE Fobancort HOE Pharmaceutical Ointment 2% w/w +0.064% OTC R E Registered by Dial
Manufacturing (M) Sdn. Bhd., Trade and Travels Pte.
Malaysia Ltd.
1593 P868 SODIUM FUSIDATE Foban HOE Pharmaceutical Cream/ Ointment 2%w/w OTC R E Registered by Dial
Manufacturing (M) Sdn. Bhd., Trade and Travels Pte.
Malaysia Ltd.
1594 P3261 SODIUM FUSIDATE Sofinox Apex Laboratories, India Cream 2% OTC R 06.01.2015 Registered by ADK
Company Pvt Ltd
1595 P1849 SODIUM FUSIDATE Fobancort HOE Pharmaceutical Cream 2%w/w OTC R E
Manufacturing (M) Sdn. Bhd.,
Malaysia
1596 P3943 SODIUM FUSIDATE (FUSIDIC ACID) Axcel Fusidic acid Kotra Pharma (M) Sdn. Bhd., Cream 2% w/w (5g tube) POM Re 01.11.2016 - Market Exclusivity
1, 2, & 3 Jalan TTC 12, Cheng 31.10.2021 given to State Trading
Industrial Estate, 75250 Organization Plc.
Melaka, Malaysia

1597 P3944 SODIUM FUSIDATE (FUSIDIC ACID) Axcel Fusidic acid Kotra Pharma (M) Sdn. Bhd., Ointment 2% w/w (5g tube) POM Re 01.11.2016 - Market Exclusivity
1, 2, & 3 Jalan TTC 12, Cheng 31.10.2021 given to State Trading
Industrial Estate, 75250 Organization Plc.
Melaka, Malaysia

1598 P554 SODIUM LACTATE Compound Sodium Fresenius Kabi, India Injection 500ml POM R E
Lactate
Intravenous
Infusion 500ml

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 98 of 113 Authorized by:DG,MFDA
 1599 P3255 SODIUM PICOSULPHATE BP Cremalax Acme Formulation,India Tablet 10 mg POM R 06.01.2015 Registered by Life
Support Pvt Ltd
1600 P1637 SODIUM VALPORATE BP Valparin Torrent, India Oral Liquid 200 mg/5ml POM R E 07.01.14 Registered by Life
Support Pvt Ltd
1601 P1636 SODIUM VALPORATE BP Valparin Torrent, India Tablet 200 mg POM R E 07.01.14 Registered by Life
Support Pvt Ltd
1602 P3728 SOLUBLE INSULIN ASPART + INSULIN NovoMix FlexPen Novo Nordisk A/S , Denmark Pre-filled injection 100U(3.5mg)/ml (30% + 70%) POM Re 24.05.2016 - Market Exclusivity
ASPART CRYSTALLIZED WITH PROTAMINE (Pre-filled pen) (3ml) 23.05.2021 given to ADK
Pharmaceutical
Company Pvt. Ltd.
1603 P2524 SPIRONOLACTONE Aldactone 100 Searle, Pakistan Tablet 100 mg POM R 23.06.2011 Registered by ADK
Company Pvt Ltd
1604 P2525 SPIRONOLACTONE Aldactone 25 Searle, Pakistan Tablet 25 mg POM R 23.06.2011 Registered by ADK
Company Pvt Ltd
1605 P4141 STAR FLOWER OIL, EVENING PRIME ROSE WellWoman Vitabiotics Ltd ,UK Capsule 100 mg + 100 mg + 5 mcg + 60 OTC R 26.08.13 Registered by Life
OIL , VITAMIN D 3, VITAMIN C, THIAMIN, Capsule mg + 10 mg + 5 mg + 36 mg + Support Pvt Ltd
RIBOFLAVIN, NIACIN,VITAMIN B6 ,FOLIC 10mg + 400 iu + 12 20 iu +
ACID, VITAMIN B, BIOTIN, VITAMIN K Biotin + 9mg + 6mg + 30 mg +
,PANTOTHENIC 100 mg,+ 12 mg
ACID,VITAMINE,MAGNESIUM,ZINC

1606 P2652 STECULIA + FRAGULA Laxinorm Sachet Sterling Lab, India. Sachet 62% + 8% POM R 02.10.2012 Registered by AMDC
Pvt Ltd
1607 P1875 SYNTHETIC VITAMIN A CONCENTRATE + Gromin Oral liquid Medley Ltd, India. Oral Liquid 2500IU(BP) + 200 IU + 1.5 OTC R
CHOLECALCIFEROL (VITAMIN D3) mg(BP) + 1.25 mg(BP)+ 0.5 mg
+THIAMINE HCL+ RIBOFLAVIN + VITAMIN (BP) + 19 mg +1.5 mg(USP) +
B6 + ASCORBIC ACID + DEXPANTHENOL + 11.5 mg (BP) + 15 mg(BP) +0.05
NIACINAMIDE + CALCIUM LACTATE + mg(BP) + 5 mg (USP) + 16.5
MAGNESIUM SULPHATE + LYSINE HCL + mg(USP) in 5ml
ZINC SULPHATE

1608 P2122 Tacrolimus Tacroz Glenmark , India Ointment 0.03% w/w POM R
1609 P2345 TAMSULOSIN HCL Urimax Cipla India Capsule 400 mcg POM R 13.05.2010 Registered by ADK
Company Pvt Ltd
1610 P2757 TAMSULOSIN HCL Maxflow CCL Pharmaceuticals, Capsule 0.4 mg POM R 08.05.2013 Registered by ADK
Pakistan Company Pvt Ltd
1611 P3620 TELMISARTAN Telsarta PharmEvo (Private) Limited, Tablet 40 mg POM Re 17.11.2015- Market Exclusivity
At Plot # A-29, Northe 16.11.2020 given to Life Support
Western Industrial Zone, Port Pvt. Ltd.
Qasim, Karachi, Karachi-
75020, Pakistan

1612 P3621 TELMISARTAN Telsarta PharmEvo (Private) Limited, Tablet 20 mg POM Re 17.11.2015- Market Exclusivity
At Plot # A-29, Northe 16.11.2020 given to Life Support
Western Industrial Zone, Port Pvt. Ltd.
Qasim, Karachi, Karachi-
75020, Pakistan

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 99 of 113 Authorized by:DG,MFDA
 1613 P3527 TELMISARTAN + HYDROCHLOROTHIAZIDE T-Sartan-H Atoz Pharmaceuticals, India Tablet 40 mg+ 12.5 mg POM Re 19.05.2015- Market Exclusivity
BP 18.05.2020 given to My Chemist
Wholesale
1614 P3528 TELMISARTAN BP T-Sartan-40 Atoz Pharmaceuticals, India Tablet 40 mg POM Re 19.05.2015- Market Exclusivity
18.05.2020 given to My Chemist
Wholesale
1615 P3529 TELMISARTAN BP T-Sartan-20 Atoz Pharmaceuticals, India Tablet 20 mg POM Re 19.05.2015- Market Exclusivity
18.05.2020 given to My Chemist
Wholesale
1616 P3977 TELMISARTAN BP T-Sar CCL Pharmaceuticals (Pvt) Ltd, Film coated tablet 20 mg POM Re 01.08.2017 - Market Exclusivity
62-Industrial estate, Kot 01.08.2022 given to State Trading
lakhpat, Lahore, Pakistan Organization Plc.

1617 P3978 TELMISARTAN BP T-Sar CCL Pharmaceuticals (Pvt) Ltd, Film coated tablet 40 mg POM Re 01.08.2017 - Market Exclusivity
62-Industrial estate, Kot 01.08.2022 given to State Trading
lakhpat, Lahore, Pakistan Organization Plc.

1618 P2847 TELMISARTAN IP Telma 20 mg Glenmark , India Tablet 20 mg POM R 07.11.2013 Registered by ADK
Company Pvt Ltd
1619 P2848 TELMISARTAN IP Telma 40 mg Glenmark , India Tablet 40 mg POM R 07.11.2013 Registered by ADK
Company Pvt Ltd
1620 P3115 TELMISARTAN IP Cresar 40 mg Cipla India Tablet 40 mg POM R 24.06.2014 Registered by ADK
Company Pvt Ltd
1621 P2849 TELMISARTAN IP Telma 80 mg Glenmark , India Tablet 80 mg POM R 07.11.2013 Registered by ADK
Company Pvt Ltd
1622 P2540 TELMISARTAN IP Telmed 20 Medley Ltd, India. Tablet 20 mg POM R 17.01.2012 Registered by ADK
Company Pvt Ltd
1623 P2541 TELMISARTAN IP Telmed 40 Medley Ltd, India. Tablet 40 mg POM R 17.01.2012 Registered by ADK
Company Pvt Ltd
1624 P3509 TELMISARTAN IP Telmed 80 Medley Ltd, India. Tablet 80 mg POM Re 19.05.2015- Market Exclusivity
18.05.2020 given to ADK Company
Pvt. Ltd.
1625 P2575 TELMISARTAN IP + HYDROCHLOROTHIAZIDE Telmed H Medley Ltd, India. Tablet 40mg + 12.5 mg POM R 08.04.2012 Registered by ADK
IP Company Pvt Ltd
1626 P3982 TELMISARTAN USP Telsure 20 Swiss Garnier Life Sciences, Film-coated tablet 20mg POM Re 20.06.2017 - Market Exclusivity
No:21-23 Industrial Area, 20.06.2022 given to AMDC Pvt.
Mehatpur, Dist UNA, Ltd.
Himachel Pradesh, 174315,
INDIA

1627 P3983 TELMISARTAN USP Telsure 40 Swiss Garnier Life Sciences, Film-coated tablet 40mg POM Re 20.06.2017 - Market Exclusivity
No:21-23 Industrial Area, 20.06.2022 given to AMDC Pvt.
Mehatpur, Dist UNA, Ltd.
Himachel Pradesh, 174315,
INDIA

1628 P4 TERAZOSIN Hytrin Acme Formulation,India Tablet 1 mg POM R E 06.01.2015 Registered by Life
Support Pvt Ltd
1629 P5 TERAZOSIN Hytrin Acme Formulation,India Tablet 2 mg POM R E 06.01.2015 Registered by Life
Support Pvt Ltd

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 100 of 113 Authorized by:DG,MFDA
 1630 P1950 TERBUTALINE + BROMHEXIN HCL BP Grilinctus BM Wardex Pharmacueticals Pvt Oral Liquid 1.5 mg+ 4 mg in 5ml POM R
Paediatric Oral Ltd, India
liquid
1631 P1949 TERBUTALINE + BROMHEXIN HCL BP Grilinctus BM Oral Wardex Pharmacueticals Pvt Oral Liquid 2.5 mg+ 8 mg POM R
liquid Ltd, India
1632 P2160 TETANUS TOXOID Tetanus Toxoid Serum Institute, India Injection ≥ 5 Lf (≥ 40IU) POM R E
1633 P2449 TETRACYCLINE Emcycline Medopharm, India Capsule 500 mg POM R E 22.10.2010 Registered by Green
Pharmacy
1634 P2263 TETRACYCLINE Tetracycline Ambalal Sarabhai Eye Ointment 3% POM R E Registered by ADK
India/Assence Pharma Pvt Ltd Company Pvt Ltd

1635 P63 TETRACYCLINE HYDROCHLORIDE USP Tetracycline Alpha Laboratories Limited, Eye Ointment 1% (10mg/gm) (3.5g) POM R E Registered by ADK
Hydrochloride India Company Pvt Ltd
1636 P3737 TETRAHYDROZOLINE HYDROCHLORIDE Allersine Duopharma (M) Sdn. Bhd., Eye Drops 0.05% (0.5mg)/ml (5ml) POM Re 24.05.2016 - Market Exclusivity
Malaysia 23.05.2021 given to Dial Trade
and Travels Pte. Ltd.
1637 P170 THEOPHYLLINE Quibron T/SR GlaxoSmithKline, Pakistan Tablet 300 mg POM R Registered by ADK
Company Pvt Ltd
1638 P176 THEOPHYLLINE Euphyllin Retard Byk Gulden Lomberg Germany Tablet 200 mg POM R

1639 P1175 THEOPHYLLINE BP Unicontin 400 Modi-Mundipharma Private Controlled 400mg POM Re 06.12.2016 - Market Exclusivity
Limited, At: Modipuram-250 Released Tablet 05.12.2021 given to AMDC Pvt.
110, Uttar Pradesh, India Ltd.

1640 P1176 THEOPHYLLINE BP Unicontin 600 Modi-Mundipharma Private Controlled 600 POM Re 06.12.2016 - Market Exclusivity
Limited, At: Modipuram-250 Released Tablet 05.12.2021 given to AMDC Pvt.
110, Uttar Pradesh, India Ltd.

1641 P4143 THIAMIN, RIBOFLAVIN, VITAMIN B6, Feroglobin Vitabiotics Ltd, UK Liquid 5 mg+ 1mg + 1 mg + 12 5 μg + OTC R 07.01.14 Registered by Life
VITAMIN B, FOLACIN, PANTOTHENIC ACID, 50 μg, 2mg + 10 mg + 10 mg + Support Pvt Ltd
CALCIUM GLYCERPPHOSPHATE,NIACIN, 10 mg + 3 mg + 0.2 mg + 0.25
IRON, ZINC, COPPER, MANGANESE mg/ 5 ml

1642 P4174 THIAMINE HCL + RIBOFLAVIN + B Complex Upha Pharmaceutical Tablet 5 mg+ 1.5 mg+1 mg +3 mcg + OTC Re 28.08.2015- Market Exclusivity
PYRIDOXINE HCL + CYANOCOBALAMIN + Manufacturing (M) Sdn. Bhd. 10 mg 27.08.2020 given to Dial Trade
NICOTINAMIDE Lot 2 & 4, Jalan P/7, Seksyen and Travels Pte. Ltd.
13, Malaysia
1643 P4152 THIAMINE MONONITRATE, RIBFLAVIN, Theragran Stress GSK, Pakistan Tablet 20 mg +10 mg + 5 mg + 12 OTC R 24.06.2014 Registered by ADK
PYRIDOXINE HCL, CYNOCOBALAMINE , mcg+30 iu + 400 mcg + 45 mcg Company Pvt Ltd
VITAMIN E, FOLIC ACID,BIOTIN, + 25 mg+ 23.9 mg + 3 mg
PANTHOTHENIC ACID, ZINC, COPPER

1644 P3804 THIAMINE MONONITRATE BP + PYRIDOXINE Vitabion Incepta Pharmaceuticals Ltd, Tablet 100mg + 200mg + 200mcg POM Re 11.10.2016- Market Exclusivity
HYDROCHLORIDE BP + CYANOCOBALAMIN Dewan Idris Road, Bara 10.10.2021 given to Dial Trade
BP Rangamatia, Zirabo, Savar, and Travels Pte. Ltd.
Dhaka, Bangladesh

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 101 of 113 Authorized by:DG,MFDA
 1645 P464 THIAMINE MONONITRATE IP + RIBOFLAVIN Neurobion Forte Merck Marker, India Injection 10 mg + 10 mg + 3 mg + 15 POM R E 15.06.2010 Registered by ADK
IP + PYRIDOXINE HCL IP + mcg + 45 mg + 50 mg Company Pvt Ltd
CYANOCOBALAMIN IP + NICOTINAMIDE IP +
CALCIUM PANTOTHENATE IP

1646 P2147 THIAMINE NITRATE BP + RIBOFLAVIN BP + Dinplex Arvind Remedies Ltd, India Capsule 10 mg+ 10 mg+ 3 mg +5 OTC R
PYRIDOXINE HYDROCHLORIDE BP + mcg+50 mg +1.5 mg+ 40 x 10
CYNOCOBALAMINE BP + NICOTINAMIDE BP Spores
+ FOLIC ACID + LACTIC ACID BACILLUS

1647 P2252 THIAMINE NITRATE BP + RIBOFLAVINE BP + Berocin NF Micro Labs ltd Capsule 10 mg BP + 10 mg BP + 3mg POM R Registered by ADK
PYRIDOXINE HCL BP + CALCIUM BP + 12.5 mgBP + 400 mcg BP Company Pvt Ltd
PANTOTHENATE BP + FOLIC ACID BP + + 15 mcg BP + 61.8 mg
CYNOCOBALAMIN BP + ZINC SULFATE BP

1648 P1942 THIAMINE PROPYL DISULPHIDE+VITAMIN B Benuron Forte Franco Indian Remedies Pvt Tablet 5.625mg+ 1. 575 mg + 5. 250 OTC R
6 +VITAMIN B2+NIACINAMIDE +VITAMIN Ltd India mg + 49.750 mg + 93.750 mg +
C+LACTOOSE 77.60 mg

1649 P902 THYMOSIN ALPHA 1 Zadaxin I.S.F S.p.A. Italy Injection 1.6mg POM R Registered by ADK
Company Pvt Ltd
1650 P2888 THYROXINE Thyronorm Acme Generics LLP, Plot No. Tablet 100 mcg POM R 18.02.2014 Registered by Life
115, HPSIDC, Indusrial Area Support Pvt Ltd
Davni, P.O. Gurumajra, Tehsil
Nalagarh, Distt. Solan (H.P)
INDIA

1651 P2889 THYROXINE Thyronorm Acme Generics LLP, Plot No. Tablet 50 mcg POM R 18.02.2014 Registered by Life
115, HPSIDC, Indusrial Area Support Pvt Ltd
Davni, P.O. Gurumajra, Tehsil
Nalagarh, Distt. Solan (H.P)
INDIA

1652 P2890 THYROXINE Thyronorm Acme Generics LLP, Plot No. Tablet 25 mcg POM R 18.02.2014 Registered by Life
115, HPSIDC, Indusrial Area Support Pvt Ltd
Davni, P.O. Gurumajra, Tehsil
Nalagarh, Distt. Solan (H.P)
INDIA

1653 P1955 TICARCILLIN + CLAVULANIC ACID Timentin 1.6 g GlaxoSmithKline, UK Injection 1.5g +100 mg POM R
1654 P1954 TICARCILLIN + CLAVULANIC ACID Timentin 3.2 g GlaxoSmithKline, UK Injection 3g + 200 mg POM R
1655 P1684 TICLOPIDINE Ticlovas USV, India Tablet 250 mg POM R
1656 P1232 TIMOLOL Nyolol Excelvision, France/Novartis Eye Drops 0.25% POM R 12.02.2014 Registerd by State
Pharma AG / Austria Trading Organization
Plc.
1657 P1233 TIMOLOL Nyolol Excelvision, France/Novartis Eye Drops 0.50% POM R 12.02.2014 Registerd by State
Pharma AG / Austria Trading Organization
Plc.
1658 P2111 Timolol Optimol Eye Drops Ashford Laboratories Ltd Eye Drops 5 mg POM R

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 102 of 113 Authorized by:DG,MFDA
 1659 P3649 TIMOLOL MALEATE USP Blotim Remington Pharmaceutical Eye Drops 0.5% POM Re 21.01.2016 - Market Exclusivity
Industries Pvt. Ltd., Pakistan 20.01.2021 given to ADK Company
Pvt. Ltd.

1660 P2344 TOBRAMYCIN Tobrex Alcon, Singapore Ophthalmic 0.30% POM R 13.06.2010 Registered by ADK
Solution Company Pvt Ltd
1661 P4441 TOBRAMYCIN Tobrex Alcon Couvreur N.V Rijksweg Ophthalmic 3mg/ml (0.3% w/v) POM Re 19.03.2019 - Market Exclusivity
14, B-2870, Puurs, Belgium Solution 5ml 18.03.2024 given to ADK
Pharmaceutical
Company Pvt. Ltd.
1662 P2391 TOBRAMYCIN Tobrex Alcon Couvreur N.V Rijksweg Ophthalmic 3mg/g (0.3%) 3.5g POM Re 19.03.2019 - Market Exclusivity
14, B-2870, Puurs, Belgium Ointment 18.03.2024 given to ADK
Pharmaceutical
Company Pvt. Ltd.
1663 P3546 TOBRAMYCIN Tobi Podhaler Novartis Pharmaceuticals Inhalation Capsule 28 mg POM Re 30.06.2015 - Market Exclusivity
Corporation , San Carlos USA 29.06.2020 given to Mediquip
Maldives Pvt. Ltd.

1664 P3502 TOBRAMYCIN + DEXAMETHASONE T-Mycin Plus Aristo Pharma Limited, Ophthalmic 0.3% + 0.1% POM Re 19.05.2015- Market Exclusivity
Bangladesh Solution 18.05.2020 given to Life Support
Pvt. Ltd.
1665 P3543 TOBRAMYCIN + DEXAMETHASONE Amgydex Remington Pharmaceutical Eye Drops 0.3% + 0.1% POM Re 30.06.2015 - Market Exclusivity
Industries, Pakistan 29.06.2020 given to ADK Company
Pvt. Ltd.
1666 P2025 TOBRAMYCIN + DEXAMETHASONE TobraDex Alcon- Convreur, B-2870 Sterile Ophthalmic 0.3% w/v + 0.1% w/v POM Re 03.10.2017 - Market Exclusivity
Puurs, Belgium Suspension 02.10.2022 given to ADK
Pharmaceutical
Company Pvt. Ltd.
1667 P4068 TOBRAMYCIN + DEXAMETHASONE TobraDex Alcon Singapore Sterile Ophthalmic 0.3% w/v + 0.1% w/v POM Re 03.10.2017 - Market Exclusivity
Manufacturing Pte Ltd 19 Suspension 02.10.2022 given to ADK
Tuas South Avenue 14 Pharmaceutical
Singapore 637313 Company Pvt. Ltd.
1668 P2114 TOBRAMYCIN USP Ocusyn Eye Drops Ashford Laboratories Ltd Eye Drops 3 mg POM R

1669 P3650 TOBRAMYCIN USP Nebra Remington Pharmaceutical Eye Ointment 0.3% POM Re 21.01.2016 - Market Exclusivity
Industries Pvt. Ltd., 18 Km 20.01.2021 given to ADK Company
Multan Road, Lahore - Pvt. Ltd.
Pakistan

1670 P3713 TOBRAMYCIN+DEXAMETHASONE Tobec-D Remington Pharmaceutical Ear Drops 0.3% (3mg) USP + 0.1% (1mg) POM Re 17.05.2016 - Market Exclusivity
Industries, Pakistan USP/ml (5ml) 16.05.2021 given to ADK
Pharmaceutical
Company Pvt. Ltd.
1671 P870 TOLNAFTATE Tolnaderm cream HOE Pharmaceutical Cream 1% w/w in 15g POM R E Registered by Dial
Manufacturing (M) Sdn. Bhd., Trade and Travels Pte.
Malaysia Ltd.
1672 P871 TOLNAFTATE Tolnaderm lotion HOE Pharmaceutical Lotion 1% w/v in 10ml POM R E Registered by Dial
Manufacturing (M) Sdn. Bhd., Trade and Travels Pte.
Malaysia Ltd.

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 103 of 113 Authorized by:DG,MFDA
 1673 P2760 TRAMADOL Supridol Neon Laboratories, India Injection 50 mg/ml NATIONALLY R 08.05.2013 Registerd by State
CONTROLLED Trading Organization
(PSYCHOTROPIC) Plc.
1674 P2165 TRANEXAMIC ACID Tranlok 500 Aristo India Injection 500 mg POM R
1675 P3201 TRANEXAMIC ACID Frabex 500 Square Formulations Capsule 500 mg (BP) POM R 06.11.2014 Registered by Dial
Ltd. Tangail, Bangladesh Trade and Travels Pte.
Ltd.
1676 P2164 TRANEXAMIC ACID Tranlok 500 Aristo India Tablet 500 mg (BP) POM R
1677 P2027 TRAVOPROST Travatan Alcon, Singapore Ophthalmic 40 mcg/ml POM R
Solution
1678 P3500 TRAVOPROST Avatan Aristo Pharma Limited, Eye Drops 0.004% POM Re 19.05.2015- Market Exclusivity
Bangladesh 18.05.2020 given to Life Support
Pvt. Ltd.
1679 P4430 TRAVOPROST Travatan Alcon Couvreur, N.V Rigsweg Ophthalmic 40mcg/ml (0.004% w/v) POM Re 19.03.2019 - Market Exclusivity
14, B-2870 Puurs, Belgium Solution 18.03.2024 given to ADK
Pharmaceuticals
Company Pvt. Ltd.
1680 P64 TRIAMCINOLONE Trinocort Ambalal Sarabhai Injection 40 mg POM R 20.05.2014 Registered by ADK
India/Assence Pharma Pvt Ltd Company Pvt Ltd

1681 P172 TRIAMCINOLONE Kenacort GlaxoSmithKline, Pakistan Injection 10 mg/ml POM R Registered by ADK
Company Pvt Ltd
1682 P174 TRIAMCINOLONE Kenacort A GlaxoSmithKline Pakistan Injection 40 mg/ml POM R Registered by ADK
Limited., 35-Dockyard Road, Company Pvt Ltd
West Wharf, Karachi

1683 P173 TRIAMCINOLONE Kenacort Bristol Myers Squibb Pakistan Tablet 4mg POM R Registered by ADK
Company Pvt Ltd
1684 P872 TRIAMCINOLONE Orrepaste HOE Pharmaceutical Paste 0.10% W/W POM R Registered by Dial
Manufacturing (M) Sdn. Bhd., Trade and Travels Pte.
Malaysia Ltd.
1685 P1808 TRIAMCINOLONE Kenalog in Orabase GlaxoSmithKline, Pakistan Ointment 1mg/gm in 5g Tube POM R E
Ointment

1686 P1805 TRIAMICINOLONE ACETONIDE +NEOMYCIN Kenacomb GlaxoSmithKline, Pakistan Ointment 1mg/gm+2mg/gm+ 100000 POM R
SULPHATE + NYSTATIN +GRAMICIDIN Ointment 10g units/gm+ 0.25 mg/gm in 10g
Tube
1687 P1806 TRIAMICINOLONE ACETONIDE +NEOMYCIN Kenacomb Otic Bristol Myers Squibb Pakistan Ear Drops 1mg/gm+2mg/gm+100000 POM R
SULPHATE +NYSTATIN + GRAMICIDIN Drops 7.5ml units/gm + 0.25 mg/gm

1688 P171 TRIAMICINOLONE ACETONIDE +NEOMYCIN Kenacomb GlaxoSmithKline, Pakistan Cream 1%+2.5mg+100000units+0.25 POM R Registered by ADK
SULPHATE+NYSTATIN + GRAMICIDIN mg/gm Company Pvt Ltd

1689 P1301 TRIBENOSIDE Glyvenol Catalent Germany Eberbach Capsule 400 mg POM R 02.02.2010 Registerd by State
GmbH/ Novartis Pharma AG, Trading Organization
Switzerland Plc.

1690 P2349 TRICLOSAN A-Septic As Gel HOE Pharmaceutical Topical Gel 0.30% OTC R 26.05.2010 Registered by Dial
Manufacturing (M) Sdn. Bhd., Trade and Travels Pte.
Malaysia Ltd.

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 104 of 113 Authorized by:DG,MFDA
 1691 P3120 TRIHEXYPHENIDYL BP Trihexyphenidyl Cresent Pharma,London Tablet 2 mg POM R 08.07.2014 Registered by Life
Support Pvt Ltd
1692 P1873 TRIMETAZIDINE Triadin Tablet Medley Ltd, India. Tablet 20mg POM R Registered by ADK
Company Pvt Ltd
1693 P25 TROPICAMIDE Mydriacyl SA. Alcon-Couvreur N.V, Ophthalmic 10.0mg/ml (0.1% w/v) POM Re E 09.04.2019 - Market Exclusivity
Rijksweg 14,B-2870 Puurs, Solution 08.04.2024 given to ADK
Belgium Pharmaceutical
Company Pvt. Ltd.
1694 P2039 TROPICAMIDE Tropicamide Ashford Laboratories Ltd Eye Drops 1% POM R
1695 P3712 TROPICAMIDE USP Mydromide Remington Pharmaceutical Eye Drops 1% (10mg)/ml (15ML) POM Re 17.05.2016 - Market Exclusivity
Industries, Pakistan 16.05.2021 given to ADK
Pharmaceutical
Company Pvt. Ltd.
1696 P2374 TYPHOID VACCINE Typherix Vaccine GlaxoSmithKline, Belgium Vaccine 25 mcg/0.5 ml POM R 05.07.2010 Registered by ADK
Company Pvt Ltd
1697 P3657 URSODEOXYCHOLIC ACID Triptor CCL Pharmaceuticals, Tablet 250 mg POM Re 21.01.2016 - Market Exclusivity
Pakistan 20.01.2021 given to State Trading
Organization Plc.

1698 P3492 URSODEOXYCHOLIC ACID BP Udihep Win-Medicare Pvt Ltd, India Tablet 150 mg POM Re 19.05.2015- Market Exclusivity
18.05.2020 given to AMDC Pvt.
Ltd.
1699 P3493 URSODEOXYCHOLIC ACID BP Udihep Forte Win-Medicare Pvt Ltd, India Tablet 300 mg POM Re 19.05.2015- Market Exclusivity
18.05.2020 given to AMDC Pvt.
Ltd.
1700 P3558 URSODEOXYCHOLIC ACID BP Ursodox -SR Micro Labs Limited, 92, Film coated 450 mg POM R 25.08.2015 Registered
SIPCOT, HOSUR-635 126 INDIA sustained-release
tablet
1701 P3559 URSODEOXYCHOLIC ACID PH. EUR. Ursodox Micro Labs ltd Capsule 250 mg POM R 25.08.2015 Registered

1702 P3097 URSODIOL(URSODEOXY CHOLIC) ACID USP Udiliv 300 Abbott India Tablet 300 mg POM R E 20.05.2014 Registered by Life
Support Pvt Ltd
1703 P3096 URSODIOL(URSODEOXYCHOLIC) ACID USP Udiliv 150 Abbott India Tablet 150 mg POM R E 20.05.2014 Registered by Life
Support Pvt Ltd
1704 P1825 VACCINE HEPATITIS A (Inactivated hepatitis Havrix A GlaxoSmithKline, Belgium Injection POM R E 05.07.2010 Registered by ADK
A virus) Company Pvt Ltd
1705 P2375 VACCINE HEPATITIS A (Inactivated hepatitis Havrix P GlaxoSmithKline, Belgium Injection POM R E 05.07.2010 Registered by ADK
A virus) Company Pvt Ltd
1706 P744 VACCINE HEPATITIS B Engerix B GlaxoSmithKline, Belgium Injection 20 mcg/ml POM R E 23.05.2010 Registered by ADK
Company Pvt Ltd
1707 P2206 VACCINE HEPATITIS B (Adult) Hepatitis B Adult Serum Institute, India Injection 1 ml contains Purified POM R Registered by ADK
Vaccine Hepatitis B surface Antigen 20 Company Pvt Ltd
mcg
1708 P2207 VACCINE HEPATITIS B (Paediatric) Hepatitis B Serum Institute, India Injection 0.5 ml contains Purified POM R Registered by ADK
Paediatric Vaccine Hepatitis B surface Antigen 10 Company Pvt Ltd
mcg

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 105 of 113 Authorized by:DG,MFDA
 1709 P2208 VACCINE MMR Priorix Vaccine Glaxo Smithkline Biologicals Injection 0.5ml (After reconsitution) POM R Registered by ADK
contains Measles Company Pvt Ltd
Virus 1000 CCID 50/dose,
Mumps Virus 5000 CCID
50/dose, Rubella
Virus 1000 CCID 50/dose

1710 P2205 VACCINE MMR MMR Vaccine Serum Institute, India Injection 0.5ml (After reconsitution) POM R Registered by ADK
contains Measles Company Pvt Ltd
Virus 1000 CCID 50/dose,
Mumps Virus 5000 CCID
50/dose, Rubella
Virus 1000 CCID 50/dose

1711 P2351 VACCINE VARICELLA Varicella GlaxoSmithKline, Belgium Vaccine Live attenuated varicella Virus POM R E
Vaccine 2000 PFU
1712 P2636 VALSARTAN Diovan 80 Novartis Farmaceutica S.A., Film coated tablet 80 mg POM R 02.10.2012 Registered by
Barbera del Valles, Spain Mediquip Maldives
Pvt. Ltd.
1713 P2637 VALSARTAN Diovan 160 Novartis Farmaceutica S.A., Film coated tablet 160 mg POM R 02.10.2012 Registered by
Barbera del Valles, Spain Mediquip Maldives
Pvt. Ltd.
1714 P3675 VALSARTAN + HYDROCHLOROTHIAZIDE Co-Diovan 160 Novartis Farma S.p.A., Torre Film coated tablet 160 mg + 12.5 mg POM Re 23.02.2016 - Market Exclusivity
Annunziata, Italy 22.02.2021 given to Mediquip
Maldives Pvt. Ltd.
1715 P3676 VALSARTAN + HYDROCHLOROTHIAZIDE Co-Diovan 80 Novartis Farma S.p.A., Torre Film coated tablet 80 mg + 12.5 mg POM Re 23.02.2016 - Market Exclusivity
Annunziata, Italy 22.02.2021 given to Mediquip
Maldives Pvt. Ltd.
1716 P3625 VALSARTAN USP Nuval PharmEvo (Private) Limited, Film coated tablet 160 mg POM Re 17.11.2015- Market Exclusivity
At Plot # A-29, Northe 16.11.2020 given to Life Support
Western Industrial Zone, Port Pvt. Ltd.
Qasim, Karachi, Karachi-
75020, Pakistan

1717 P3626 VALSARTAN USP Nuval PharmEvo (Private) Limited, Film coated tablet 80 mg POM Re 17.11.2015- Market Exclusivity
At Plot # A-29, Northe 16.11.2020 given to Life Support
Western Industrial Zone, Port Pvt. Ltd.
Qasim, Karachi, Karachi-
75020, Pakistan

1718 P3682 VALSARTAN USP + HYDROCHLOROTHIAZIDE Nuval-D PharmEvo (Private) Limited, Film coated tablet 80 mg + 12.5 mg POM Re 01.03.2016- Market Exclusivity
USP At Plot # A-29, Northe 28.02.2021 given to Life Support
Western Industrial Zone, Port Pvt. Ltd.
Qasim, Karachi, Karachi-
75020, Pakistan

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 106 of 113 Authorized by:DG,MFDA
 1719 P3683 VALSARTAN USP + HYDROCHLOROTHIAZIDE Nuval-D PharmEvo (Private) Limited, Film coated tablet 160 mg + 25 mg POM Re 01.03.2016- Market Exclusivity
USP At Plot # A-29, Northe 28.02.2021 given to Life Support
Western Industrial Zone, Port Pvt. Ltd.
Qasim, Karachi, Karachi-
75020, Pakistan

1720 P3167 VILDAGLIPTIN Galvus Novartis Farmaceutica S.A, Tablet 50mg POM Re 15.05.2018 - Market Exclusivity
Barbera del Valles, Spain 14.05.2023 given to Mediquip
Maldives Pvt. Ltd.
1721 P3169 VILDAGLIPTIN + METFORMIN HCL Galvus Met Novartis Pharma Productions Film-coated Tablet 50mg + 1000mg POM Re 06.06.2017 - Market Exclusivity
GmbH, Wehr, Germany 06.06.2022 given to Mediquip
Maldives Pvt. Ltd.
1722 P3168 VILDAGLIPTIN + METFORMIN HCL Galvus Met Novartis Pharma Productions Film-coated tablet 50mg + 850mg POM Re 06.06.2017 - Market Exclusivity
GmbH, Wehr, Germany 06.06.2022 given to Mediquip
Maldives Pvt. Ltd.
1723 P3537 VILDAGLIPTIN + METFORMIN HCL Galvus Met Novartis Pharma Produktions Film coated tablet 50mg + 500mg POM Re 15.05.2018 - Market Exclusivity
GmbH, Wehr, Germany 14.05.2023 given to Mediquip
Maldives Pvt. Ltd.
1724 P4163 VIT B6, VIT B2 , VIT B1, VIT B12, Zinvital Saga Laboratories, India Capsule 3 mg + 10 mg + 10 mg + B12 OTC R Registered by Dial
NIACINAMIDE, VIT A, VIT C, FOLIC ACID ,VIT 5 mcg + 50 mg + 5000 iu + 50 Trade and Travels Pte.
E, CALCIUM PANTOTHENATE, ZINC OXIDE, mg + 1 mg + VIT E 25 iu + 12.5 Ltd.
CUPRIC OXIDE ,MANGANESE CHLORIDE, mg + 2.5 mg+ 1.4 mg + 60 mcg
SELENIUM, (CHROMIC) (CHROMIC) 65 mcg

1725 P2431 ViTAMIIN E Enat Mega Life Sciences Capsule 400 mg POM R Registered by ADK
Ltd,Thailand Company Pvt Ltd
1726 P4148 VITAMIN A , VITAMIN D, VITAMIN C, Diabetone Capsule Vitabiotics, UK Capsule A 700 μg + 30 mg, 120 mg + 15 OTC R 18.02.14 Registered by Life
THIAMIN, RIBOFLAVIN, NIACIN, FOLACIN, mg + 5 mg + 45 mg + 500μg + Support Pvt Ltd
VITAMIN B 12, BIOTIN, PANTOTHENIC ACID, 12 9μg + 200μg+ 10 mg+ 8 mg
IRON, ZINC, CHROMIUM, SELENIUM + 15 mg +200μg + 100 μg + 1
, COPPER , MANGANESE, IODINE mg + 2 mg + 100μg

1727 P4135 VITAMIN A ,CAROTENOIDS , VITAMIN D, Wellman Vitabiotics, England Tablet 750 mcg + 2 mg, + 3 5 mcg + 60 OTC R 18.06.13 Registered by Life
VITAMIN C, THIAMIN, VITAMIN B, mg + 12 mg +6 9 mg + 5 mg + Support Pvt Ltd
RIBOFLAVIN, VITAMIN B12 ,BIOTIN, 9 mcg+ 50 mcg + 500 mcg + 20
FOLACIN ,NIACIN, PANTOTHENIC mg + 10 mg, + 20 mg + 50 mg +
ACID,VITAMIN E ,MAGNESIUM ,ZINC 15 mg
1728 P2627 VITAMIN A + VITAMIN D3 + VITAMIN E + Zincovit Apex Laboratories, India Tablet 5000 IU+ 400 IU + 15 mg + 10 OTC R 18.09.2012 Registered by ADK
THIAMINE NITRATE + RIBOFLAVIN + mg + 10 mg + 2 mg+7.5 mg Company Pvt Ltd
PYRIDOXINE HCL 2 + CYANOCOBALAMIN

1729 P2430 VITAMIN A + VITAMIN B1+ VITAMIN B2 + Vitacap Mega Life Sciences Capsule 5000 IU + 5 mg+ 5 mg+ 2 mg+ 5 OTC R Registered by ADK
VITAMIN B 6 + VITAMIN B 12 + VITAMIN C + Ltd,Thailand mcg+ 75 mg+ 400 IU+15 mg + Company Pvt Ltd
VITAMIN D3 + VITAMIN E+ NICOTINAMIDE + 45 mg+ 1000 mcg+ 50 mg+ 70
FOLIC ACID + FERROUS FUMARATE + mg +1 mg + 0.01 mg+ 50 mg
DIBASIC CALCIUM PHOSPHATE + COPPER+
MANGANESE SULPHATE + ZINC SULPHATE
DRIED

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 107 of 113 Authorized by:DG,MFDA
 1730 P4173 Vitamin A + Vitamin D + Vitamin B 1 + Uphavit Upha Pharmaceutical Oral Liquid 3000iu + 400 iu + 2.5 mg + 1.25 OTC Re 28.08.2015- Market Exclusivity
Vitamin B2 + Vitamin B6 + Vitamin B12 + Manufacturing (M) Sdn. Bhd., mg + 1 mg + 2.5 mcg + 10 mg + 27.08.2020 given to Dial Trade
Nicotinamide + Calcium Pantothenate Malaysia 0.25 mg and Travels Pte. Ltd.

1731 P4170 VITAMIN A + VITAMIN D + VITAMIN E + Proviton Plus Upha Pharmaceuticals Capsule (Strip pack 5000iu+ 400 iu+15 iu+10 mg +5 OTC Re 19.05.2015 – Market Exclusivity
VITAMIN B1 (THIAMINE) + VITAMIN B2 CoQ10 and loose Packs) mg+4 mg +15 mcg+0.06 mg+25 18.05.2020 given to Dial Trade
(RIBOFLAVIN) + VITAMIN B6 (PYRIDOXINE) + mg+0.90 mg+0.1 mg+0.33 mg+ and Travels Pte. Ltd.
VITAMIN B12 (CYANOCOBALAMINE) + 2 mg+5 mg+0.9 mg + 40 mg+50
BIOTIN + NICOTINAMIDE + FOLIC ACID + mg +7.5 mg +0.05 + 0.3 mg
COPPER + MANGANESE + MAGNESIUM + +18.5 mg +5 mg +50 mg +30
IRON + ZINC + CALCIUM + LECITHIN + mg
INOSITOL + IODINE + LYSINE HCL +
PHOSPHORUS + POTASSIUM

1732 P1947 VITAMIN A + VITAMIN D 3 + THIAMINE Beetrion Franco Indian Remedies Pvt Tablet 2500 IU(IP)+ 200 IU + 2 + 3 OTC R E
PROPYL DISULPHIDE + VITAMIN B2 + Ltd India mg(IP)+ 1.5 mg (IP) + 25 mg(IP)
VITAMIN B 6+NIACIANAMIDE+CALCIUM +5 mg (IP)+ 300 mcg
PANTHOTHENATE + FOLIC ACID

1733 P1124 VITAMIN A BP + VITAMIN D3 USP + DIBASIC Calcivita Caps Medicap Ltd, Thailand. Capsule 2500IU + 400IU + 150mg + OTC R E
CALCIUM PHOSPHATE USP + CALCIUM 50mg
CARBONATE IP
1734 P2507 VITAMIN A USP +VITAMIN D3 USP + Multibionta Merck Limited, Pakistan Oral Liquid 3000 IU +400 IU +1.2 + 1mg + OTC R 25.01.2011 Registered by ADK
RIBOFLAVIN USP + PYRODOXINE (USP) + 3mcg + 50mg + 10mg + 5mg + Company Pvt Ltd
CYANOCOBALAMIN USP + ASCORBIC ACID 3mg + 75 mcg + 40 mg + 43
USP + NICOTINAMIDE USP + PANTOTHE USP mg + 0.5 mg + 3mg + 5 mg + 5
+ IRON USP + IODINE BP + CALCIUM mg in 5ml
PHOSPHORUS USP + MAGNESE USP +
MAGNESIUM USP + CHOLINE + INOSITOL
USP
1735 P4169 VITAMIN A, VITAMIN D, Wellbaby Multi- Vitabiotics, England Drops 350µg+ 7µg+ 2 mg+12mg+0.2 OTC Re 21.04.2015- Market Exclusivity
VITAMIN E, VITAMIN C, THIAMIN, vitamin Drops mg+0.25 mg+ 0.25mg+ 0.4µ+ 20.04.2020 given to Life Support
RIBOFLAVIN, VITAMIN B 6, VITAMIN B 50µg + 0.9 mg+ 3mg+ 8µg+ 2.2 Pvt. Ltd.
12, FOLIC ACID , PANTOTHENIC mg+ 1.5 mg+10mg+ 150 mg/ml
ACID , NIACIN, BIOTIN, IRON,
ZINC, L-LYSINE, MALDT EXTRACT

1736 P4168 VITAMIN A, VITAMIN D,VITAMIN E, Wellbaby Liquid Vitabiotics, England Syrup 133µg +2µg+5 mg = 30 mg + OTC Re 21.04.2015- Market Exclusivity
VITAMIN C, THIAMIN, RIBOFLAVIN,NIACIN, 0.5 mg+0.8 mg+ 6 mg+ 0.5 mg+ 20.04.2020 given to Life Support
VITAMIN B12, PANTOTHENIC 80µg+ 1µ+ 2 mg+ 4mg+ 2.5 Pvt. Ltd.
ACID,IRON,ZINC, COPPER, FLAXSEED,MALT mg+ 100µg +31 mg + 500
EXTRACT mg/5ml
1737 P4153 VITAMIN A, COLECALCIFEROL, VITAMIN E, Zincovit - S Apex Laboratories Pvt Ltd, Syrup 800 iu+100 iu+2.5 iu +0.75mg+ OTC R 18.02.14 Registered by ADK
RIBOFLAVIN, SODIUM PHOSPHATE, India 0.50 mg + 0.50 Company Pvt Ltd
PYRIDOXINE HCL, CYNAECOBALAMIN, mcg+0.50mg+7.5 mg +50
DEXPANTHENOL, NICOTINAMIDE, mcg+100 mcg + 22.20mg/5 ml
POTASSIUM IODINE,
COPPERSULPHATEPENTAHYDRATE, ZINC
SULPHATEHEPTAHYDRATE

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 108 of 113 Authorized by:DG,MFDA
 1738 P4151 Vitamin A, Vitamin D, Tiamine Mononitrate, Theragran H GSK, Pakistan Tablet 8.33 iu +133iu + 3.3 mg + 3.3 OTC R 24.06.2014 Registered by ADK
Riboflavin, Niacinamide, Calsium mg, + 33.3 mg+11.7 mg+ 0.67 Company Pvt Ltd
Panthothenate, Copper , Magnesium , Iron mg + 41 .7 mg+ 66.7 mg + 12
Elemental, Vitamin B 12, Folic Acid, Vitamin 50 mcg + 0.33 mg + 100 mg
C

1739 P4145 VITAMIN A, VITAMIN D, VITAMIN E, Menopace with Vitabiotics Ltd, UK Tablet 400μg + 10μg, + 30 mg+ 45 OTC R 07.01.14 Registered by Life
VITAMIN C, THIAMIN, RIBOFLAVIN , Calcium mg+ 10 mg + 5 mg+ Niacin 20 Support Pvt Ltd
NIACIN, MG,VITAMIN B6, FOLIC ACID, mg + 10 mg + 400mg+ 9μg+
VITAMIN B12, BIOTIN,PANTOTHENIC ACID, 30μg+ 30mg + 700 mg + 8 mg
CALCIUM , IRON, MAGNESIUM, ZINC + 100 mg+ 15 mg+ 250 μg, +
IODIINE, MANGANESE, COPPER , 0.5 mg, + 1000μg +100μg
CHROMIUM, SELENIUM
1740 P4166 VITAMIN A, VITAMIN D2, VITAMIN B1 , Forceval Adult CatalentGermany Eberbach Capsule 2500iu + 400 iu+ 1.2 mg + 1.6 OTC R
VITAMIN B , VITAMIN B 6 , VITAMIN B 12 , GmbH, Germany mg + 6 2 mg+ 3mcg + 60 mg+
VITAMIN C , VITAMIN E, BIOTIN, 10mg+100 mcg+ 18 mg + 4 mg
NICOTINAMIDE , PANTOTHENIC ACID, FOLIC + 400 mcg + 100 mg + 12 mg +
ACID , CALCIUM , IRON , COPPER , 2 mg + 77 mg, 30 mg+ 4 mg+
PHOPHORUS, MAGNESIUM, POTASSIUM, 15 mg+ 140 mcg+ 30 mg+ 50
ZINC IODINE , MANGANESE, SELENIUM , mcg +200 mcg
CHROMIUM, MOLYBDENUM

1741 P4146 VITAMIN A, VITAMIN D3, VITAMIN E , Menopace night Vitabiotics, UK Tablet 750μg + 25μg +30 mg+ 45 mg + OTC R 18.02.14 Registered by Life
VITAMIN C, THIAMIN , ROBOFLAVIN, 15 mg + 5 mg+ 24 mg + 10 mg, Support Pvt Ltd
NIACIN,VITAMIN B6,FOLIC ACID, VITAMIN B 400 μg + B 12 20μg+ 50μg 30
12, BIOTIN, PANTOTHENIC ACID, mg + 60 mg + 6 mg + 15 mg+
MAGNESIUM, IRON,ZINC, COPPER , 1000 μg + 2 mg + 110 μg+
MAGNESIUM, SELENIUM, CHROMIUM, 40μg + 150 μg
IODINE
1742 P1946 VITAMIN B 12 IP + VITAMIN D 3 IP Omilcal Forte Franco Indian Remedies Pvt Tablet 25 mcg + 3IU OTC R E
Ltd India
1743 P1940 VITAMIN B ACETATE IP + FOLIC ACID + ZINC Dexorange Softesule Pvt Ltd, India Capsule 25 mg + 0.5 +20.61 mg OTC R E
SULPHATE MONOHYDRATE USP
1744 P4222 VITAMIN B1 + VITAMIN B2 + VITAMIN B6 + Axcel B - Complex Kotra Pharma (M) Sdn. Bhd., Tablet 10mg + 3mg + 1mg + 5mcg + POM Re 13.03.2018 - Market Exclusivity
VITAMIN B12(CYANOCOBALAMINE) + 1,2 & 3 Jalan TTC 12, Cheng 1mg + 25mg 12.03.2023 given to State Trading
CALCIUM PANTOTHENATE + NICOTINAMIDE Industrial Estate, 75250 Organization Plc.
Melaka, Malaysia
1745 P2857 VITAMIN B1 + VITAMIN B6 + VITAMIN B12 Neurovit Fofrte Hovid Bhd, Malaysia Tablet 242.5 mg + 250 mg + 1 mg OTC R 07.11.2013 Registered by GKT
Pharmacy
1746 P705 VITAMIN B1 +VITAMIN B2 +VITAMIN Cytexin p GlaxoSmithKline, SriLanka Oral Liquid 3mg+ 3mg+2mg + 23mg/ 15ml OTC R E 03.02.2010 Registered by ADK
B6+Nicotinamide Company Pvt Ltd
1747 P4164 VITAMIN B1, VITAMIN B2, NIACINAMIDE, D- Vitalise Astron Ltd, SriLanka Oral Liquid 1.4 mg +1.8 mg +18 mg +6 mg OTC R Registered by ADK
PANTHENOL, VITAMIN B6, D-BIOTIN USP, +2 mg +150 mcg+ 400 mcg+ 60 Company Pvt Ltd
FOLIC ACID USP, VITAMIN C, VITAMIN D3, mg+ 200iu+10mg
VITAMIN E

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 109 of 113 Authorized by:DG,MFDA
 1748 P4157 VITAMIN B1, VITAMIN B2, VITAMIN B3, Bezinc Astron Ltd, SriLanka Capsule 10 MG +10 MG +50 MG +15 OTC R Registered by ADK
VITAMIN B5, VITAMIN B6, VITAMIN B 12 , MG +3MG +15 MCG Company Pvt Ltd
VITAMIN C , FOLIC ACID, ZINC +150MG+1 MG +20 MG

1749 P4155 VITAMIN B1, VITAMIN B2, VITAMIN B6, Becosules Astron Ltd, SriLanka Syrup 12.5 MG+ 6.25MG + 2.5MG OTC R Registered by ADK
VITAMIN B12, NIACINAMIDE, D- +3.75 MG +25 MCG + 6.25MG Company Pvt Ltd
PANTHENOL, FOLIC ACID + 0.25 MG/5 ml
1750 P4154 VITAMIN B1, VITAMIN B2, VITAMIN Becosules Astron Limited, Srilanka Capsule 50MG+25 MG + 10 MG +15 OTC R 19.08.2014 Registered by ADK
B6,VITAMIN B12, NIACINAMIDE , CALCIUM MCG +100 MG +25 MG +1 MG Company Pvt Ltd
D -PANTHONOATE,FOLIC ACID,VITAMIN C, +150 MG + 5 MG
COQ10
1751 P704 Vitamin B1+ VITAMIN B2 +VITAMIN B3 + Cytexin A GlaxoSmithKline, SriLanka Oral Liquid 6.3mg+ 2.5mg+ 25mg+ 1.3mg+ OTC R E 03.02.2010 Registered by ADK
VITAMIN B5+VITAMIN B6+VITAMIN B12 0.6mg+ 6mcg /5ml Company Pvt Ltd

1752 P1123 VITAMIN C Medicrafts NAT – C Medicap Ltd, Thailand. Tablet 1000mg OTC R E
Tablets
1753 P4126 VITAMIN C Champs C Upha Pharmaceutical Tablet 100mg OTC R
strawberry Manufacturing (M) Sdn. Bhd.,
Malaysia
1754 P4127 VITAMIN C Champs C Orange Upha Pharmaceutical Tablet 100mg OTC R
Manufacturing (M) Sdn. Bhd.,
Malaysia
1755 P4128 VITAMIN C Champs C Sugar Upha Pharmaceutical Tablet 100mg OTC R
free Manufacturing (M) Sdn. Bhd.,
Malaysia
1756 P2732 VITAMIN C Sunlife Vitamin C Sunlife Laboratories, Germany Tablet 1000 mg OTC R 16.04.2013 Registered by ADK
(ASCORBIC ACID) Company Pvt Ltd
1757 P2730 VITAMIN C + ZINC Sunlife Sunlife Laboratories, Germany Capsule 225 mg + 225 mg OTC R 16.04.2013 Registered by ADK
Multivitamins Company Pvt Ltd
Vitamin C + Zinc
Capsule
1758 P3584 VITAMIN C (ASCORBIC ACID + SODIUM Citrex Pharmaniaga Manufacturing Tablet 1000 mg (350mg + 731.2mg) OTC Re 06.10.2015- Market Exclusivity
ASCORBATE) Berhad, 11A, Jalan P/1, 05.10.2020 given to Dial Trade
Kawasan Perusahaan Bangi, and Travels Pte. Ltd.
43650 Bandar Baru Bangi,
Selangor Darul Ehsan,
Malaysia

1759 P4171 VITAMIN C (ASCORBIC ACID) BP + VITAMIN I-Gold Aristopharma Ltd., Capsule 60mg+30mg+15 mg+ 6 OTC Re 19.05.2015 – Market Exclusivity
E (as ALPHA TOCOPHERYL ACETATE) BP + Bangladesh mg+2mg 18.05.2020 given to Life Support
ZINC (as ZINC OXIDE) BP + LUTEIN Ph. Gr. + Pvt. Ltd.
COPPER (as CUPRIC OXIDE) Ph. Gr.

1760 P4131 Vitamin C , Vitamin E, VitaminA, ACD & E Vitamin Sunlife Laboratories, Germany Pastille 60 mg + 9 mg + 800 μg + 5 μg OTC R 16.04.13 Registered by ADK
Vitamin D Fruitjellies for Company Pvt Ltd
Children

1761 P4130 VITAMIN C , NIACIN , VITAMIN ,VITAMIN B6 Sunlife Sunlife Laboratories, Germany Tablet 70 mg + 10 mg + 8 mg, 0.5 mg OTC R 16.04.13 Registered by ADK
,VITAMIN B2 ,VITAMIN B1 ,FOLIC ACID Multivitamins + 0.9 mg + 0.8 mg +150 iu + Company Pvt Ltd
IU,VTAMIN B 12 1.5iu

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 110 of 113 Authorized by:DG,MFDA
 1762 P4180 VITAMIN C , NIACIN , VITAMIN ,VITAMIN B6 Sunlife Sunlife Laboratories, Germany Tablet 60 mg + 18mg, 10 mg+ 2mg + OTC R 16.04.13 Registered by ADK
,VITAMIN B2 ,VITAMIN B1 ,FOLIC ACID Multivitamins for 16 mg + 14 mg+ 200 iu+ 12 iu+ Company Pvt Ltd
IU,VTAMIN B 13 kids 150 iu
1763 P4125 VITAMIN C +LYSINE Champs C with Upha Pharmaceutical Tablet 100mg + 50mg/ Tab OTC R
Lysine Manufacturing (M) Sdn. Bhd.,
Malaysia
1764 P4144 VITAMIN D, CALCIUM, MAGNESIUM, ZINC Osteocare Vitabiotics Ltd, UK Tablet 200 μg + 800mg + 300 mg +10 OTC R 07.01.14 Registered by Life
mg Support Pvt Ltd
1765 P4139 VITAMIN D, VITAMIN E , VITAMIN C, Perfectil Tablet 5μg + 40 mg + 60 mg + 8 mg + OTC R 18.06.13 Registered by Life
THIAMIN , RIBOFLAVIN , NIACIN , VITAMIN 4 mg + Niacin 18 mg + 10 mg + Support Pvt Ltd
B6 , FOLIC ACID , VITAMIN B ,BIOTIN 500μg + 9μg + 45μg + 40 mg+
,PENTOTHENIC ACID ,IRON , MAGNESIUM , Iron 12 mg + 75 mg, + 15 mg
ZINC ,IODINE, MAGNESIUM , ZINC , COPPER 200μ + 75 mg + 15mg +
, CYSTINE 1000μg + 10μ

1766 P4142 VITAMIN Liveril Tablet Vitabiotics Ltd, UK Tablet 20μg + 30mg+ 10mg, 6mg,10 OTC R 07.01.14 Registered by Life
D,VITAMINE,THIAMIN,RIBOFLAVIN,VITAMI mg, 500μg, 12 30μg, 20 mg,6 Support Pvt Ltd
N,FOLACIN,VITAMIN B, PANTOTHENIC mg, 15 mg, 1000μg, 4 mg,
ACID,IRON ,ZINC 150μg,2mg
,COPPER,MAGNESE,SELENIUM, NATURAL
MIXED CAROTENOIDS
1767 P40 VITAMIN D3 + CALCIUM Calcy Alembic Pharmaceuticals Tablet 250mg OTC R E Registered by Dial
Limited India Trade and Travels Pte.
Ltd.
1768 P4110 VITAMIN D3 + CALCIUM Calcy Alembic Pharmaceuticals Tablet 500mg OTC R Registered by Dial
Limited, India Trade and Travels Pte.
Ltd.
1769 P4111 VITAMIN D3 + CALCIUM Cipcal Cipla, India Tablet 500 mg OTC R Registered by ADK
Company Pvt Ltd
1770 P4112 VITAMIN E Evion 200 Merck Ltd, India Capsule 200 mg OTC R Registered by ADK
Company Pvt Ltd
1771 P4113 VITAMIN E Evion 400 Merck Ltd, India Capsule 400 mg OTC R Registered by ADK
Company Pvt Ltd
1772 P4114 VITAMIN E Evion 600 Merck Ltd, India Capsule 600 mg OTC R Registered by ADK
Company Pvt Ltd
1773 P4119 VITAMIN E Etovit USV, India Capsule 200 mg OTC R
1774 P4120 VITAMIN E Etovit USV, India Capsule 400 mg OTC R

1775 P1941 VITAMIN E ACETATE IP + VIATMIN C IP + Ecarotin Softesule Pvt Ltd, India Capsule 25 mg + 150 mg + 75 mcg + OTC R
SELENIUM SULPHATE MONOHYDRATE USP 61.8 mcg
+ ZINC SULPHATE MONOHYDRATE USP

1776 P1122 VITAMIN PREPERATION SLEN Medicap Ltd, Thailand. Capsule OTC R

1777 P1120 VITAMIN PREPERATION (Marine Protein Glow Medicap Ltd, Thailand. Capsule OTC R
plus Herbal Extracts and Vitamin Capsules)

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 111 of 113 Authorized by:DG,MFDA
 1778 P1121 VITAMIN PREPERATION(Bilberry Extract iiCare Medicap Ltd, Thailand. Capsule OTC R
plus Carotenoids Capsules)

1779 P4138 VITAMIN, , VITAMIN D , VITAMIN C , Menopace Vitabiotics, England Tablet 750 mg + 5 mcg, 45 mg + OTC R 18.06.13 Registered by Life
THIAMIN , VITAMIN B6 , RIBOFLAVIN 10mg + 6 9 mg + Riboflavin 5 Support Pvt Ltd
,NIACIN ,VITAMIN B6, FOLIC ACID mg + 20 mg + 10mg + 500mcg
,VITAMIN B 12 ,BIOTIN , PANTOTHENIC + 12 9 mcg + 30 mcg + 30 mg
ACID ,MAGNESIUM ,IRON 6 ,ZINC , COPPER , + 100 mg + 6 mg + 15 mg +
MAGNESE , SELENIUM, CHROMIUM, IODINE Copper 1000 mcg + 0.5 mg, +
100 mcg + 50 mcg + 225 mcg

1780 P4156 VITAMIN,VITAMIN B1, VITAMIN B2 Minterra Astron Ltd, SriLanka Capsule A 7500 IU + 4 MG +4 MG + 25 OTC R Registered by ADK
USP,NIACINAMIDE B3 , VITAMIN B 5 , MG + 6 MG + 0.5 MG + 1MG + Company Pvt Ltd
VITAMIN B6, FOLIC ACID, VITAMIN B 12, 1.5MCG+ 60 MG + 750 IU + 5IU
VITAMIN C , VITAMIN D2 , VITAMIN E

1781 P313 VITAMINS Betavit AFR Cipla India Capsule OTC R E Registered by ADK
Company Pvt Ltd

1782 P462 VITAMINS Polybion Forte Merck Marker, Pakistan Injection OTC R E Registered by ADK
Company Pvt Ltd

1783 P4162 VITAMINS B COMPLEX + C and ZINC Becosule Z Astron Ltd, SriLanka Capsule 50 MG+25 mg +100 mg+ USP OTC R Registered by ADK
25 mg + 10 mg+ 10 mg+ 1 mg+ Company Pvt Ltd
15 mcg
1784 P2722 VITMAIN D3+VITAMIN A+CYNACOBALAMIN Nutravit Hovid Bhd, Malaysia Oral Liquid 400 IU+ 4000 IU+1.5μg+2m g + POM R 05.03.2013 Registered by GKT
+RIBOFLAVIN 2 MG+PYRIDOXINE 2 mg,+ 2 mg + 3.25 mg + 10mg Pharmacy
HCL+THIAMINE +CALSIUM + 17.5mg +100 mg in 5ml
PENTOTHENATE+NICOTINAMIDE
+ASCORBIC ACID + LYSINE HCL

1785 P3510 VOGLIBOSE Vogli Medley Ltd, India. Mouth Dissolving 0.2 mg POM Re 19.05.2015- Market Exclusivity
Tablet 18.05.2020 given to ADK Company
Pvt. Ltd.
1786 P3511 VOGLIBOSE Vogli Medley Ltd, India. Mouth Dissolving 0.3 mg POM Re 19.05.2015- Market Exclusivity
Tablet 18.05.2020 given to ADK Company
Pvt. Ltd.
1787 P2904 WARFARIN SODIUM Warfarin Cresent Pharma,London Tablet 1 mg POM R E 18.02.2014 Registered by Life
Support Pvt Ltd

1788 P3118 WARFARIN SODIUM Warfarin Cresent Pharma,London Tablet 5 mg POM R E 08.07.2014 Registered by Life
Support Pvt Ltd

1789 P3119 WARFARIN SODIUM Warfarin Cresent Pharma,London Tablet 3 mg POM R E 08.07.2014 Registered by Life
Support Pvt Ltd

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 112 of 113 Authorized by:DG,MFDA
 1790 P319 WARFARIN SODIUM Warf Cipla India Tablet 5 mg POM R E Registered by ADK
Company Pvt Ltd

1791 P1920 ZINC SULPHATE + BENZALKONIUM Eye Glow Relief Duopharma (M) Sdn. Bhd., Eye Drops 0.25% + 0.01% OTC R
CHLORIDE Malaysia
1792 P2638 ZOLENDROINIC Aclasta Novartis Pharma AG Injection 5 mg POM R 02.10.2012 Registered by
Switzerland Mediquip Maldives
Pvt. Ltd.

1.For the Products in this list where the formulation is mentioned, that specific formulation only can be imported
2.For those products in which the fomulation is not mentioned, the product imported should be of export quality and not specified for a specific market

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 113 of 113 Authorized by:DG,MFDA
 List 2: Primordial Products List (PP)
These are the products that has been in Approved Drug List from the beginning as approved products but not registered with full dossier submission. This has been kept in the
Approved Drug List due to the unavailability of any alternative, plus that these products are kept on the fact that it has been in the market for a long time.
Serial No

Product Generic name Product name Manufacturer / Company Dosage form strength Catergory Status Essentiality Remarks
No name

1 P1306 4-CARBOXYMETHYLAMINO-4- Otogesic J&J, India Ear Drops 0.84% + 1.1%(USP) + POM PP
AMINO-DIPHENYLSULPHONE 0.4% + 76% +
DIBUCAINE + N.N- 18%(USNF)
DIOXYMETHYLCARBOMIDE +
GLYCERINE + POLYTHENE GLYCOL
(USNF)
2 P1764 ACETAZOLAMIDE IP Diamox Wyeth Limited, Plot No. L- Uncoated Tablet 250 mg POM PP
137, Phase III-A, Verna
Industrial Estate, Verna,
Goa 403 722, India

3 P573 ACETYL SALICYLIC ACID ASA German Remedies India Tablet 50 mg POM PP E

4 P1411 ACETYL SALICYLIC ACID Colsprin Reckkit & Colman, India Tablet 325 mg POM PP E

5 P1412 ACETYL SALICYLIC ACID Colsprin 100 Reckkit & Colman, India Tablet 100 mg POM PP E

6 P1927 ACETYLSALICYLIC ACID (ASPIRIN) Ecosprin-150 USV Private Limited, INDIA Enteric coated 150 mg POM PP E
(gastro-resistant)
Tablet

7 P1926 ACETYLSALICYLIC ACID (ASPIRIN) Ecosprin-75 USV Private Limited, INDIA Enteric coated 75 mg POM PP E
(gastro-resistant)
Tablet

8 P1410 ACETYLSALICYLIC ACID IP Disprin Reckkit Benckiser (India) Uncoated 350mg POM PP E
Ltd.,At 61 & 62, Hootagalli Effervescent
Ind. Area, Mysore -570 018 Tablet
India
9 P503 ACICLOVIR/ ACYCLOVIR Ocuvir FDC India Cream 3% 5g POM PP E
10 P504 ACICLOVIR/ ACYCLOVIR Ocuvir FDC India Tablet 400 mg POM PP E

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 1 of 52 Authorized by:DG,MFDA
 11 P632 ACICLOVIR/ ACYCLOVIR Zovirax GlaxoSmithKline, Pakistan Tablet 400 mg POM PP E

12 P123 ACICLOVIR/ ACYCLOVIR Bearax Beacons Singapore Tablet 400 mg POM PP E

13 P1784 ACICLOVIR/ ACYCLOVIR Avorax Xepa Soul Pattinson Tablet 400 mg POM PP E
14 P607 ACICLOVIR/ ACYCLOVIR Zovirax GlaxoSmithKline Ointment Eye 3% 5g POM PP E
15 P502 ACICLOVIR/ ACYCLOVIR Ocuvir FDC India Oral Liquid 400 mg/5ml POM PP E
16 P631 ACICLOVIR/ ACYCLOVIR Zovirax Draxis Pharma Inc, Quebec, Eye Ointment 3% w/w ( 4.5 g) POM PP E
Canada (For
GlaxoSmithKline Pakistan
Limited, 35 - Dockyard
Road, West Wharf, Karachi)

17 P504 ACICLOVIR/ ACYCLOVIR Ocuvir FDC Limited, L-121/B, Phase Dispersible Tablet 400mg POM PP E
III/A, Verna Induatrial
Estate, Verna-403 722,
Salcete, Goa. India

18 P1596 ACICLOVIR/ ACYCLOVIR IP Herpex-5% TORRENT Cream 5% w/w POM PP E

PHARMACEUTICALS LTD.
Indrad 382 721, Dist
Mehsana, INDIA
19 P432 ADRENOCHROME Styptochrome Dr Reddys Laboratories Injection 1.5 mg/ ml POM PP
India
20 P181 ADRENOCHROME Cadisper C Cadila/ Zydus Health Care Tablet 60mg+100mg + 20mg OTC PP
(ADRENOCHROME India + 40mg + 1 mg
MONOSEMICARBAZONE+METHYL
HESPERIDIN+ RUTIN+VITAMIN C +
DIBASIC CALCIUM PHOSPHATE)

21 P706 ALBENDAZOLE BP Zentel GlaxoSmithKline Pakistan Oral Liquid 200mg / 5ml OTC PP E
Limited F/268, S.I.T.E., (Suspension)
Karachi.
22 P1553 ALBENDAZOLE IP Zentel GlaxoSmithKline, Oral Liquid 400mg / 10ml OTC PP E
Pharmaceuticals Limited. (Suspension) ( 10 ml Bottles)
At: 34th K.M. Tumkur Road,
Teppada Begur,
Nelamangala, Bangalore
Rural-562-123 , INDIA
23 P574 ALBENDAZOLE IP Zelbend DM Pharma, INDIA Oral Liquid 200mg / 5ml OTC PP
24 P633 ALLOPURINOL BP Zyloric GlaxoSmithKline Pakistan Tablet 100 mg POM PP E
Limited F/268, S.I.T.E.,
Karachi.
25 P608 ALLOPURINOL IP Zyloric GlaxoSmithKline Tablet 100 mg POM PP E
Pharmaceuticals Limited,
INDIA

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 2 of 52 Authorized by:DG,MFDA
 26 P130 ALLYLOESTRENOL Fetugard GlaxoSmithKline, India Tablet 5 mg POM PP

27 P1851 ALLYLOESTRENOL Gestin Infar India Tablet 5 mg POM PP

28 P182 ALLYLOESTRENOL Gravidin Cadila/ Zydus Health Care Tablet 5 mg POM PP
India
29 P1597 ALPRAZOLAM Alprax Torrent, India Tablet 0.25 mg INTERNATIONALLY PP E
CONTROLLED
(PSYCHOTROPIC)
30 P1598 ALPRAZOLAM Alprax Torrent, India Tablet 0.5 mg INTERNATIONALLY PP E
CONTROLLED
(PSYCHOTROPIC)
31 P2069 ALPRAZOLAM SR ALPRAX-SR Torrent, India Tablet 0.5 mg INTERNATIONALLY PP E
CONTROLLED
(PSYCHOTROPIC)
32 P2070 ALPRAZOLAM SR ALPRAX-SR Torrent, India Tablet 1 mg INTERNATIONALLY PP
CONTROLLED
(PSYCHOTROPIC)
33 P2071 ALPRAZOLAM SR ALPRAX-SR Torrent, India Tablet 1.5mg INTERNATIONALLY PP
CONTROLLED
(PSYCHOTROPIC)
34 P1372 ALUMINUM Gestid Tablet Sun pharmaceuticals Tablet 300 mg+25 mg+50 OTC PP E
HYDROXIDE+MAGNESIUM Industry ,India mg+10 mg
HYDROXIDE+MAGNESIUM
TRISILICATE+ SIMETHICONE

35 P1324 AMBROXOL HYDROCHLORIDE IP + Benadryl CR Johnson & Johnson Oral Liquid 15mg + 100mg POM PP
GUAIPHENESIN IP Limited., At: 34th KM, (Syrup) (50 ml Bottles)
Tumkur Road, T-Begur,
Nelamangala, Bangalore
Rural-562 123, INDIA

36 P229 AMIKACIN Amicip Akums Drugs Injection 100 mg/ml POM PP

Pharmaceuticals
37 P230 AMIKACIN Amicip Akums Drugs Injection 250 mg/ml POM PP E
Pharmaceuticals
38 P1177 Amiloride Hydrochloride USP + Moduretic OBS Pakistan (Pvt) Ltd. C- Tablet 5mg + 50mg POM PP
Hydrochlorthiazide USP 14, S.I.T.E., KARACHI -
75700.
39 P1535 AMINEPTINE Survector Servier Research & Tablet 100 mg POM PP
Pharmaceuticals, Pakistan

40 P1728 AMINO ACIDS Aminodrip Wockhardt, India Injection 500ml IP POM PP

41 P609 AMINOPHYLLINE Amphyll GlaxoSmithKline, Pakistan Tablet 100mg POM PP E

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 3 of 52 Authorized by:DG,MFDA
 42 P2467 Amiodarone Hydrochloride IP Cordarone SANOFI WINTHROP Injection 150mg/3ml POM PP E
INDUSTRIE, 1, rue de la
Vierge, Ambares et Lagrave
33565 Carbon Blanc, Cedex,
FRANCE
43 P1178 AMITRIPTYLINE Tryptanol MSD, Pakistan Tablet 10 mg POM PP E
44 P1179 AMITRIPTYLINE Tryptanol MSD, Pakistan Tablet 25 mg POM PP E
45 P1727 AMITRIPTYLINE Tryptomer Wockhardt, India Tablet 25 mg IP POM PP E
46 P1601 AMITRIPTYLINE Amiline Torrent, India Tablet 10 mg POM PP E
47 P209 AMITRIPTYLINE Sarotena Lundbeck India Pvt. Ltd. Tablet 10 mg POM PP E
HYDRODROCHLORIDE IP At:B-249/250, 2nd Stage
Peenya Industrial Estate
Bangalore-560 058, INDIA
48 P210 AMITRIPTYLINE Sarotena Lundbeck India Pvt. Ltd. Tablet 25 mg POM PP E
HYDRODROCHLORIDE IP At:B-249/250, 2nd Stage
Peenya Industrial Estate
Bangalore-560 058, INDIA

49 P433 AMLODIPINE Stamlo Dr Reddys Laboratories Tablet 2.5 mg POM PP E

India
50 P231 AMLODIPINE Amlopress Cipla India Tablet 2.5 mg POM PP E

51 P511 AMLODIPINE Amodep FDC India Tablet 10mg POM PP E

52 P915 AMLODIPINE Calchek Ipca, India Tablet 2.5mg POM PP E
53 P1602 AMLODIPINE Amlocor Torrent, India Tablet 2.5mg POM PP E
54 P177 AMLODIPINE BESILATE IP Amlodac Zydus Healthcare, INDIA Tablet 2.5mg POM PP E

55 P1363 AMOXICILLIN Mox kid Sun pharmaceuticals Tablet 125 mg POM PP E

Industry ,India
56 P1572 AMOXICILLIN SODIUM Amoxil SmithKline Beecham Injection 500mg POM PP E
Pharmaceuticals, Clarendon
Road, Worthing, UK
(for GSK, PAKISTAN)

57 P232 AMOXICILLIN TRIHYDRATE IP Novamox Medispray Laboratories Oral Drops 100 mg / ml ( 10 ml) POM PP E
Pvt. Ltd. 346-348, Kundaim (Paediatric)
Industrial Estate, Goa 403
115, INDIA (UNDER THE
TECHNICAL GUIDANCE OF
CIPLA LTD.)

58 P1578 AMPHOTERICIN B Fungizone IV SPPL, India Injection 50mg/vial POM PP E

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 4 of 52 Authorized by:DG,MFDA
 59 P1365 AMPICILLIN Roscillin Sun Pharmaceutical Capsule 250 mg POM PP E
Industries, India
60 P1077 AMPICILLIN Ampilin Lyka Labs Limited, India Capsule 250 mg POM PP E

61 P1079 AMPICILLIN Ampilin Lyka Labs Limited, India Capsule 500 mg POM PP E

62 P185 AMPICILLIN Tricil Cadila/ Zydus Health Care Capsule 250mg POM PP E
India
63 P186 AMPICILLIN Tricil Cadila/ Zydus Health Care Capsule 500mg POM PP E
India
64 P1456 AMPICILLIN Ampicillin Rhone Poulenc Capsule 250 mg POM PP E
65 P1457 AMPICILLIN Ampicillin Rhone Poulenc Capsule 500 mg POM PP E
66 P233 AMPICILLIN Ampisyn Cipla India Capsule 250 mg POM PP E
67 P235 AMPICILLIN Ampisyn Cipla India Capsule 500 mg POM PP E
68 P1815 AMPICILLIN Hipen Cipla India Capsule 500mg POM PP E
69 P466 AMPICILLIN Acilin Efroze Pakistan Capsule 250 mg POM PP E
70 P837 AMPICILLIN Ampicillin Hindustan Antibiotics, India Capsule 250 mg POM PP E

71 P1078 AMPICILLIN Ampilin Lyka Labs Limited, India Injection 250 mg POM PP E

72 P1080 AMPICILLIN Ampilin Lyka Labs Limited, India Injection 500 mg POM PP E

73 P183 AMPICILLIN Ampicillin Cadila/ Zydus Health Care Injection 250 mg/ml POM PP E
India
74 P184 AMPICILLIN Ampicillin Cadila/ Zydus Health Care Injection 500 mg/ml POM PP E
India
75 P206 AMPICILLIN Zycillin Cadila/ Zydus Health Care Injection 250mg/vial POM PP E
India
76 P207 AMPICILLIN Zycillin Cadila/ Zydus Health Care Injection 500mg/vial POM PP E
India
77 P1810 AMPICILLIN Campicilin Cadila/ Zydus Health Care Injection 250mg POM PP E
India
78 P234 AMPICILLIN Ampisyn Cipla India Injection 250 mg POM PP E
79 P1814 AMPICILLIN Hipen Cipla India Injection 500 mg/ml POM PP E
80 P1370 AMPICILLIN Roscillin DT Sun Pharmaceutical Tablet 125 mg POM PP E
Industries, India
81 P1371 AMPICILLIN Roscillin DT Sun Pharmaceutical Tablet 250 mg POM PP E
Industries, India
82 P1364 AMPICILLIN Roscillin Sun Pharmaceutical Oral Drops 100mg/ml POM PP E
Industries, India
83 P1367 AMPICILLIN Roscillin Sun Pharmaceutical Oral Liquid 250 mg / 5 ml POM PP E
Industries, India
84 P512 AMPICILLIN Ampicillin FDC India Oral Liquid 125 mg / 5 ml POM PP E
85 P637 AMPICILLIN + CLOXACILLIN Ampiclox GlaxoSmithKline, Pakistan Injection 250 mg + 250 mg POM PP E

86 P1083 AMPICILLIN + CLOXACILLIN Basin Lyka BDR India Capsule 500mg POM PP E

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 87 P1669 AMPICILLIN + CLOXACILLIN Ampicillin & Cloxacillin USV, India Capsule 250 mg+250 mg POM PP E

88 P513 AMPICILLIN + CLOXACILLIN Duoclox FDC India Capsule 250 mg POM PP E

89 P516 AMPICILLIN + CLOXACILLIN Duoclox FDC India Capsule 500 mg POM PP E
90 P514 AMPICILLIN + CLOXACILLIN Duoclox FDC India Injection 250 mg POM PP E
91 P517 AMPICILLIN + CLOXACILLIN Duoclox FDC India Injection 500 mg POM PP E
92 P1084 AMPICILLIN + CLOXACILLIN Basin Lyka BDR India Injection 500mg/ml POM PP E
93 P515 AMPICILLIN + CLOXACILLIN Duoclox FDC India Oral Liquid 250 mg /5 ml POM PP E
94 P518 AMPICILLIN + CLOXACILLIN Duoclox FDC India Oral Liquid 500 mg /5 ml POM PP E
95 P1670 AMPICILLIN + CLOXACILLIN Ampicillin & Cloxacillin USV, India Tablet 125 mg+125 mg POM PP E

96 P1368 AMPICILLIN SODIUM Roscillin Ranbaxy Laboratories Capsule 500 mg POM PP E

Limited KH. No. 1341-42,
Village Bhatoli Kalan P.O.
Barotiwala, INDIA

97 P1366 AMPICILLIN SODIUM IP Roscillin 250 Sun Pharmaceutical Ind. Injection 250 mg ( 5 ml) POM PP E
Ltd., Acme Plaza Andheri-
Kurla Road Andheri ( E),
Mumbai - 400 059, At:
Nagarjuna Sagar Nalgonda,
Dist. Telangana State, INDIA

98 P1369 AMPICILLIN SODIUM IP Roscillin 500 Sun Pharmaceutical Ind. Injection 500 mg POM PP E
Ltd., Acme Plaza Andheri-
Kurla Road Andheri ( E),
Mumbai - 400 059, At:
Nagarjuna Sagar Nalgonda,
Dist. Telangana State, INDIA

99 P636 AMPICILLIN TRIHYDRATE BP + Ampiclox 500 GlaxoSmithKline Pakistan Capsule 250 mg + 250 mg POM PP E
CLOXACILLIN SODIUM BP Limited F/268, S.I.T.E.,
Karachi.
100 P638 AMPICILLIN TRIHYDRATE BP + Ampiclox 250 GlaxoSmithKline Pakistan Capsule 125 mg + 125 mg POM PP E
CLOXACILLIN SODIUM BP Limited F/268, S.I.T.E.,
Karachi.
101 P634 AMPICILLIN TRIHYDRATE BP + Ampiclox GlaxoSmithKline Pakistan Oral Drops 60 mg + 30 mg in POM PP E
CLOXACILLIN SODIUM BP Limited, F/268, S.I.T.E., (Neonatal) 0.6ml ( 20 ml Bottle)
Karachi, Pakistan

102 P635 AMPICILLIN TRIHYDRATE BP + Ampiclox GlaxoSmithKline Pakistan Oral Liquid (Syrup 125mg + 125mg per POM PP E
CLOXACILLIN SODIUM BP Limited, F/268, S.I.T.E., ) (in powder form) 5ml ( 20 ml )
Karachi, Pakistan

MTG Division, MFDA Rec. Name: Approved Drug List

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 103 P2825 ANHYDROUS DEXTROSE + Iveolyte M Fresenius Kabi India Injection 5 g + 0.13 g + 0.028 g POM PP E Each Shipment should be
POTASSIUM CHLORIDE + Ltd,India accompanied by the batch
POTASSIUM PHOSPHATE DIBASIC certificates

104 P1214 ANTAZOLINE + TETRAZOLIN + MHP Spersallerg Novartis Cibavision, Eye Drops 0.05% + 0.4% POM PP
Cellulose Pakistan
105 P1714 ASCORBIC ACID Vit C Vulcan, India Injection 500 mg/5ml POM PP E
106 P1789 ASCORBIC ACID Vitamin C Xepa Soul Pattinson Injection 500 mg /5ml OTC PP
107 P3597 ASCORBIC ACID Limcee Ambalal Sarabhai Chewable Tablet 100 mg OTC PP
India/Assence Pharma Pvt
Ltd
108 P1529 ASPARTAME Canderal Searle, India Tablet 20 x 1g OTC PP
109 P916 ATENOLOL Tenolol Ipca, India Tablet 25 mg POM PP E
110 P1816 ATENOLOL IP Hipres-25 CIPLA LTD., 20, Industrial Uncoated Tablet 25 mg POM PP E
Area-1, Baddi (H.P.) 173
205, INDIA

111 P1603 ATENOLOL IP Betacard-25 TORRENT Uncoated Tablet 25 mg POM PP E

PHARMACEUTICALS LTD. 32
No. Middle Camp, NH-31A,
East District, Gangtok,
Sikkim-737 135, INDIA

112 P757 AZATHIOPRINE Imuran GlaxoSmithKline, SriLanka Injection 50 mg/vial POM PP E

113 P613 AZATHIOPRINE Imuran GlaxoSmithKline, India Tablet 50mg POM PP E

114 P755 AZATHIOPRINE Imuran GlaxoSmithKline, SriLanka Tablet 25 mg POM PP E

115 P756 AZATHIOPRINE Imuran GlaxoSmithKline, SriLanka Tablet 50 mg POM PP E

116 P1516 AZELAIC ACID Skinoren Schering AG, Germany Cream 20% 15gm POM PP
117 P1515 AZELAIC ACID BAYER Skinoren Medipharm (Pvt.) Ltd., 108- Cream 0.2g (20%) POM PP
Kotlakhpat Industrial
Estate, Lahore, India

118 P575 AZELASTINE Azep Nasal Spray Cadila Health Care Nasal Spray 0.14mg/actuation in POM PP
Ltd/German Remedies 10ml
119 P4202 B1, B2, B6 3MG, NICOTINAMIDE, Cobadex Forte GSK, SriLanka Capsule 10mg+10mg+100mg OTC PP
B12, C1, CALCIUM PENTOTHENATE +15mcg +
50mg+50mg
120 P4200 B1, B2, B6, B12, C 150MG, Polybion Merck Ltd, India Tablet 10MG +10MG+3MG OTC PP
NICOTINAMIDE, CALCIUM +15MCG+50MG+25
PENTOTHENATE MG

MTG Division, MFDA Rec. Name: Approved Drug List

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 121 P238 BECLOMETASONE Beclate Cipla India Aerosol 50 mcg/md POM PP E

122 P240 BECLOMETASONE Beclate Cipla India Capsule 200 mg POM PP E

123 P648 BECLOMETASONE Beconase GlaxoSmithKline, Aerosol 50 mcg/md POM PP E
Pakistan/Srilanka
124 P649 BECLOMETASONE Becotide GlaxoSmithKline, Aerosol 50 mcg/md POM PP E
Pakistan/Srilanka
125 P806 BECLOMETASONE Beclomethasone Glenmark , India Topical Ointment 0.03% POM PP

126 P242 BECLOMETASONE + CHINOFORM Beclate C Cipla India Cream 0.025% + 3% POM PP

127 P243 BECLOMETASONE + NEOMYCIN Beclate N Cipla India Cream 0.025% + 0.5% in 15g POM PP

128 P244 BECLOMETASONE + SALBUTAMOL Aerocort Cipla India Aerosol 50mcg+100mcg/md POM PP

129 P1929 BECLOMETASONE Quadriderm RF Torrent Pharmaceuticals Cream 0.025% w/w + 1% POM PP E
DIPROPIONATE IP + Ltd. Plot No. 810, Sector-III, w/w
CLOTRIMAZOLE IP + NEOMYCIN Industrial Area, Pithampur, + 0.5% w/w + 0.1%
SULPHATE IP + CHLOROCRESOL IP Dist. Dhar - 454 775 (M.P.), w/w (10g)
(AS A PRESERVATIVE) India

130 P1430 BENZOYLMETRONIDAZOLE Flagyl Abbott Healthcare Pvt. Ltd., Oral Liquid 200 mg/5ml (60ml) POM PP E
(METRONIDAZOLE) IP INDIA (Suspension)
131 P4181 BETACAROTENE, VITAMIN C, Oxigard Astron Ltd, Sri Lanka Capsule 15mg, 200mg, 100mg OTC PP
VITAMIN E
132 P698 BETAMETHASONE Betnesol N GlaxoSmithKline, Pakistan ENT Solution 0.10% POM PP E

133 P689 BETAMETHASONE Betnesol GlaxoSmithKline, Pakistan Eye Drops 0.1% 5ml POM PP E

134 P652 BETAMETHASONE Betnesol GlaxoSmithKline, Injection 4 mg/ml POM PP E

Pakistan/Srilanka
135 P651 BETAMETHASONE Betnesol GlaxoSmithKline, Tablet 0.5 mg POM PP E
Pakistan/Srilanka
136 P650 BETAMETHASONE Betnelan GlaxoSmithKline, Tablet 0.5 mg POM PP E
Pakistan/Srilanka/India

137 P700 BETAMETHASONE Betnovate GlaxoSmithKline, Pakistan Topical Ointment 0.10% POM PP E

138 P701 BETAMETHASONE Betnovate Scalp GlaxoSmithKline, Pakistan Topical Solution 0.10% POM PP E

139 P1517 BETAMETHASONE Celestone Schering AG, Germany Eye Drops 1% POM PP E
140 P751 BETAMETHASONE Betnovate GlaxoSmithKline, India Cream 0.1% 20g POM PP E

MTG Division, MFDA Rec. Name: Approved Drug List

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 141 P653 BETAMETHASONE Betnovate GlaxoSmithKline, Cream 0.1% 20g POM PP E
Pakistan/Srilanka
142 P752 BETAMETHASONE Betnovate GlaxoSmithKline, India Lotion 0.1% 20ml POM PP E

143 P758 BETAMETHASONE Betnovate GlaxoSmithKline, SriLanka Cream 0.1% 5g POM PP E

144 P759 BETAMETHASONE Betnovate GlaxoSmithKline, SriLanka Cream 0.1% 15g POM PP E

145 P762 BETAMETHASONE Betnovate GlaxoSmithKline, SriLanka Lotion 0.1% 30ml POM PP E

146 P761 BETAMETHASONE Betnovate GlaxoSmithKline, SriLanka Topical Ointment 0.1% 15g POM PP E

147 P760 BETAMETHASONE Betnovate GlaxoSmithKline, SriLanka Topical Ointment 0.1% 5g POM PP E

148 P764 BETAMETHASONE + CHINOFORM Betnovate C GlaxoSmithKline, Pakistan Topical Ointment 0.1% + 3% POM PP E

149 P656 BETAMETHASONE + NEOMYCIN Betnovate N GlaxoSmithKline, Cream 0.12% + 0.5% POM PP E
Pakistan/Srilanka
150 P767 BETAMETHASONE + NEOMYCIN Betnovate N GlaxoSmithKline, SriLanka Cream 0.1% + 0.5% 5g POM PP E

151 P769 BETAMETHASONE + NEOMYCIN Betnovate N GlaxoSmithKline, SriLanka Cream 0.1% + 0.5% 15g POM PP E

152 P690 BETAMETHASONE + NEOMYCIN Betnesol N GlaxoSmithKline, India Eye Drops 0.1%+0.5% POM PP E

153 P655 BETAMETHASONE + NEOMYCIN Betnesol N GlaxoSmithKline, Eye Ointment 0.1%+0.5% POM PP E
Pakistan/Srilanka
154 P716 BETAMETHASONE + NEOMYCIN Betnovate N GlaxoSmithKline, India Topical Ointment 0.12% + 0.5% POM PP E

155 P657 BETAMETHASONE + NEOMYCIN Betnovate N GlaxoSmithKline, Topical Ointment 0.12% + 0.5% POM PP E
Pakistan/Srilanka
156 P768 BETAMETHASONE + NEOMYCIN Betnovate N GlaxoSmithKline, SriLanka Topical Ointment 0.1% + 0.5% 5g POM PP E

157 P770 BETAMETHASONE + NEOMYCIN Betnovate N GlaxoSmithKline, SriLanka Topical Ointment 0.1% + 0.5% 15g POM PP E

158 P1062 BETAMETHASONE + SALICYLIC Lupiderm S Lupin Laboratories Ltd, Topical Ointment 0.05%w/w + 3%w/w POM PP E
ACID India in 10g
159 P763 BETAMETHASONE + Betnovate C GlaxoSmithKline Cream 0.10% w/w + 3.0% POM PP E
CLIOQUINOL + CHLOROCRESOL Pharmaceuticals Limited, w/w + 0.1% w/w
India
160 P709 BETAMETHASONE IP Betnelan GlaxoSmithKline Tablet 0.5mg POM PP E
Pharmaceuticals Limited.
At: A-10, M.I.D.C., Ambad-
Pathardi Block, Nashik 422
010, INDIA

MTG Division, MFDA Rec. Name: Approved Drug List

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 161 P714 BETAMETHASONE SODIUM Betnesol N GlaxoSmithKline Pakistan Eye Ointment 0.1% w/w + 0.5% POM PP E
PHOSPAHATE BP + NEOMYCIN Limited, 35-Dockyard Road, w/w in 5g tube
SULPHATE BP West Wharf, Karachi ,
PAKISTAN

162 P654 BETAMETHASONE SODIUM Betnesol N GlaxoSmithKline Pakistan Eye / Ear / Nose 0.1% w/v + 0.5% w/v POM PP E
PHOSPHATE BP + NEOMYCIN Limited, 35-Dockyard Road, Drops in 7.5ml
SULPHATE BP West Wharf, Karachi ,
PAKISTAN

163 P711 BETAMETHASONE SODIUM Betnesol GlaxoSmithKline Oral Drops 0.5ml /ml ( 15 ml) POM PP E
PHOSPHATE IP Pharmaceuticals Limited, At
34th K.M. Tumkur Road,
Teppada Begur,
Nelamangaia, Bangalore
Rural -562 123, INDIA

164 P710 BETAMETHASONE SODIUM Betnesol GlaxoSmithKline Tablet 0.5 mg POM PP E

PHOSPHATE IP Pharmaceuticals Limited.
At: A-10, M.I.D.C., Ambad-
Pathardi Block, Nashik 422
010, INDIA

165 P713 BETAMETHASONE SODIUM Betnesol N GlaxoSmithKline Eye / Ear Drops 0.1% w/v + 0.5% w/v POM PP E
PHOSPHATE IP + NEOMYCIN Pharmaceuticals Limited, + 0.005% w/v in 5ml
SULPHATE IP + THIOMERSAL IP (AS At: Plot No. 32, Sipcot
PRESERVATIVE) Industrial Complex, Hosur
635 126, INDIA

166 P712 BETAMETHASONE SODIUM Betnesol GlaxoSmithKline Injection 4mg + 0.5% w/v /ml POM PP E
PHOSPHATE IP + PHENOL IP (AS Pharmaceuticals Limited.
PRESERVATIVE) At: Plot No. 32, Sipcot
industrial Complex, Phase-
1, Hosur 635 126, INDIA

167 P699 BETAMETHASONE VALERATE IP + Betnovate GlaxoSmithKline Skin Cream 0.10% w/w + 0.1% POM PP E
CHLOROCRESOL (AS Pharmaceuticals Limited. w/w ( 20 g)
PRESERVATIVE) IP At: A-10, M.I.D.C., Ambad-
Pathardi Block, Nashik 422
010, INDIA

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
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 168 P715 BETAMETHASONE VALERATE IP + Betnovate N GlaxoSmithKline Cream 0.10% w/w + 0.5% POM PP E
NEOMYCIN SULPHATE IP + Pharmaceuticals Limited, w/w + 0.1 % w/w in
CHLOROCRESOL IP (AS At: Plot No. C-1, Madkaim 20g
PRESERVATIVE) Industrial Estate, Post
Mardol, Ponda, Goa 403
404, Mumbai, India

169 P521 BETAXOLOL Iobet FDC India Eye Drops 0.50% POM PP
170 P469 BEZAFIBRATE Lipocor Efroze Pakistan Tablet 200 mg POM PP
171 P124 BISACODYL Bisacodyl (Beacons) Beacons Singapore Tablet 10 mg POM PP E
172 P919 BROMHEXINE Bromhexine Ipca Laboratories Pvt Ltd, Oral Liquid 8mg/5 ml POM PP E
India
173 P921 BROMHEXINE HYDROCHLORIDE Solvin Ipca Laboratories Ltd. Tablet 8mg POM PP E
BP Sejavta, Ratlam 457 002,
INDIA
174 P918 BROMHEXINE HYDROCHLORIDE IP Bromhexine Hydrochloride Ipca Laboratories Ltd. C-6, Tablet 8 mg POM PP E
Sara Ind. Estate, Chakrata
Road, Rampur, Dehradun
248 197, India

175 P920 BROMHEXINE HYDROCHLORIDE BP Solvin Ipca Laboratories Ltd. Oral Liquid (Elixir) 4 mg/5 ml (120ml POM PP E
Sejavta, Ratlam 457 002, bottle)
INDIA
176 P579 BROMHEXINE HYDROCHLORIDE IP Bisolvon Cadila Healthcare Limited., Uncoated Tablet 8 mg POM PP E
P.O. Baddi, Dist. Solan (H.P.)-
173 205. INDIA

177 P917 BROMHEXINE HYDROCHLORIDE IP Bromhexine Hydrochloride Ipca Laboratories Ltd. Oral Liquid (Elixir) 4 mg/5 ml POM PP E
Sejavta, Ratlam 457 002,
INDIA
178 P1409 CALAMINE IP + Caladryl Maneesh Pharmaceuticals Lotion 8% w/v + 1.0% w/v + OTC PP E
DIPHENHYDRAMINE Ltd. T-172, M.I.D.C. Bhosari, 2.37% v/v (100ml )
HYDROCHLORIDE IP + ETHANOL Pune-411 026, INDIA
(95%) IP
179 P1373 CALCIUM CARBONATE Sovical Sun pharmaceuticals Tablet 500 mg POM PP E
Industry ,India
180 P4186 CALCIUM CARBONATE, VITAMIN Shelcal Elder India/Akums Drugs Oral Liquid 250mg + 125mg OTC PP
D3 Pharmaceuticals Ltd, India /5ml

181 P1245 CALCIUM GLUBIONATE + CALCIUM Macalvit Novartis, India Oral Liquid 1.18gm + 260mg + OTC PP E
LACTOBIONATE + VITAMIN D3 100iu /5ml

182 P1261 CALCIUM GLUCONATE Calcium Sandoz Novartis, Pakistan Tablet 500mg Ca2+ POM PP E
(Effervescent)

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 183 P1279 CALCIUM LACTATE GLUCONATE + CAC 1000 Novartis Pharma (Pakistan) Effervescent 1000 mg + 500 mg + OTC PP E
VITAMIN C (ASCORBIC ACID) + Ltd. Petaro Road, Jamshoro, Tablet 327 mg
CALCIUM CARBONATE Dist. Dadu, Pakistan

184 P1064 CAPTOPRIL Capotril Lupin Laboratories Ltd, Tablet 12.5mg POM PP
India
185 P1065 CAPTOPRIL Capotril Lupin Laboratories Ltd, Tablet 25 mg POM PP
India
186 P470 CAPTOPRIL Capril Efroze Pakistan Tablet 12.5 mg POM PP
187 P471 CAPTOPRIL Capril Efroze Pakistan Tablet 25 mg POM PP
188 P472 CAPTOPRIL Capril Efroze Pakistan Tablet 50 mg POM PP
189 P1730 CAPTOPRIL Aceten Wockhardt, India Tablet 12.5mg IP POM PP
190 P1731 CAPTOPRIL Aceten Wockhardt, India Tablet 25mg IP POM PP
191 P1604 CARBAMAZEPINE Carbatol Torrent, India Tablet 100 mg POM PP E
192 P1251 CARBAMAZEPINE Tegrital Novartis, India Tablet 400 mg POM PP E
193 P1250 CARBAMAZEPINE Tegretol Novartis, India Oral Liquid 100mg / 5ml POM PP E
194 P1248 CARBAMAZEPINE Tegrital Novartis, India Tablet (Chewable) 100 mg POM PP E

195 P1263 CARBAMAZEPINE Tegral Novartis, Pakistan Oral Liquid 20mg/ml POM PP E

196 P1605 CARBAMAZEPINE IP Carbatol-200 TORRENT Uncoated Tablet 200 mg POM PP E

PHARMACEUTICALS LTD. 32
No. Middle Camp, NH-31A,
East District, Gangtok,
Sikkim-737 135, INDIA

197 P1606 CARBIDOPA + LEVODOPA Tidomet forte Torrent, India Tablet 25 mg +250 mg POM PP E
198 P1180 CARBIDOPA USP + LEVODOPA USP Sinemet OBS Pakistan (Pvt) Ltd. C- Tablet 25mg+250mg POM PP E
14, S.I.T.E., KARACHI -
75700. PAKISTAN
199 P1194 CARBIMAZOLE IP Neo-Mercazole 10 Abbott Healthcare Pvt. Ltd. Uncoated Tablet 10 mg POM PP E
Village Bhatauli Khurd, P.O.
Baddi-173205,Dist. Solan,
HimachalPradesh, INDIA

200 P1195 CARBIMAZOLE IP Neo-Mercazole 5 Abbott Healthcare Pvt. Ltd. Uncoated Tablet 5 mg POM PP E
Village Bhatauli Khurd, P.O.
Baddi-173205,Dist. Solan,
HimachalPradesh, INDIA

201 P1375 CEFACLOR Keflor Sun pharmaceuticals Capsule 250 mg POM PP E

Industry ,India

MTG Division, MFDA Rec. Name: Approved Drug List

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 202 P1376 CEFACLOR Keflor MR Sun pharmaceuticals Capsule 375 mg POM PP E
Industry ,India
203 P497 CEFACLOR Ceclor Eli Lilly Italia, Italy Capsule 250mg POM PP E
204 P499 CEFACLOR Ceclor Eli Lilly Italia, Italy Capsule 500mg POM PP E
205 P498 CEFACLOR Ceclor Eli Lilly Italia, Italy Tablet 375mg POM PP E
206 P1374 CEFACLOR Keflor Sun pharmaceuticals Oral Liquid 125 mg / 5ml POM PP E
Industry ,India
207 P496 CEFACLOR Ceclor Eli Lilly Italia, Italy Oral Liquid 125mg/5ml POM PP E
208 P1067 CEFADROXIL Odoxil Suspension Lupin Laboratories Ltd, Oral Liquid 125mg/5ml POM PP E
India
209 P1068 CEFADROXIL Odoxil tablet Lupin Laboratories Ltd, Tablet 250mg POM PP E
India
210 P1086 CEFATAXIME Lyforan Lyka BDR India Injection 1 gm POM PP E
211 P1380 CEFAZOLIN SODIUM IP Reflin 1g Sun Pharmaceutical Ind. Injection 1 gm (5ml vial) POM PP E
Ltd., Acme Plaza Andheri-
Kurla Road Andheri ( E),
Mumbai - 400 059, At: J-
174. M.I.D.C., Tarapur,
Boisar, Dist. Thane - 401
506, INDIA

212 P1381 CEFAZOLIN SODIUM IP Reflin 250mg Sun Pharmaceutical Ind. Injection 250 mg (5ml vial) POM PP E
Ltd., Acme Plaza Andheri-
Kurla Road Andheri ( E),
Mumbai - 400 059, At: J-
174. M.I.D.C., Tarapur,
Boisar, Dist. Thane - 401
506, INDIA

213 P1382 CEFAZOLIN SODIUM IP Reflin 500mg Sun Pharmaceutical Ind. Injection 500 mg (5ml vial) POM PP E
Ltd., Acme Plaza Andheri-
Kurla Road Andheri ( E),
Mumbai - 400 059, At: J-
174. M.I.D.C., Tarapur,
Boisar, Dist. Thane - 401
506, INDIA

214 P1071 CEFOTAXIME Cefantral Lupin Laboratories Ltd, Injection 1 gm POM PP E

India
215 P875 CEFOTAXIME Omnatax Hoechst Marion Roussel Injection 1 gm POM PP E
India/Aventis Pharma

216 P876 CEFOTAXIME Omnatax Hoechst Marion Roussel Injection 250 mg POM PP E
India/Aventis Pharma

217 P1460 CEFOTAXIME Cefotaxime Rhone Poulenc Injection 250 mg POM PP E

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 218 P1072 CEFOTAXIME SODIUM IP Cefantral LUPIN LTD., 116, 1st Floor, Injection 500 mg POM PP E
K. B. Complex, Opp,
Mahavir Nagar, Vapi - 396
195, Gujarat, INDIA, At:
75/1. G.I.D.C. Vapi, Gujarat -
396 195, INDIA

219 P1732 CEFOTAXIME SODIUM IP Zetaxim Innova Captab Pvt. Ltd., Injection 250mg POM PP E
1281/1, Hill Top Industrial
Estate, Near EPIP Phase I,
Jharmajri, Baddi, Dist: Solan
. (H.P.) 173205, INDIA
(Marketed By Wockhard)

220 P1087 CEFTRIAXONE Lyfaxone Lyka BDR India Injection 1 gm POM PP E

221 P720 CEFUROXIME Supacef GlaxoSmithKline, India Injection 1.5 gm POM PP E

222 P721 CEFUROXIME Supacef GlaxoSmithKline, India Injection 250 mg POM PP E

223 P660 CEFUROXIME Zinacef GlaxoSmithKline, Injection 500mg/vial POM PP E ADK Company Pvt Ltd
Pakistan/Srilanka
224 P772 CEFUROXIME AXETIL Zinnat GlaxoSmithKline Tablet 125 mg POM PP E
225 P1378 CEPHALEXIN Sporidex Sun Pharmaceutical Oral Liquid 125 mg/ 5 ml POM PP E
Industries, India
226 P1379 CEPHALEXIN Sporidex Dis-Tab Sun Pharmaceutical Tablet 250 mg POM PP E
Industries, India
227 P1085 CEPHALEXIN Sepexin Lyka BDR India Oral Liquid 125 mg/ml POM PP E
228 P1069 CEPHALEXIN Ceff Forte Lupin Laboratories Ltd, Oral Liquid 125mg/5ml POM PP E
India
229 P1070 CEPHALEXIN Ceff-kid Lupin Laboratories Ltd, Tablet 125mg POM PP E
India
230 P1377 CEPHALEXIN IP Sporidex Sun Pharmaceutical Ind. Oral Drops 100mg / ml POM PP E
Ltd., Kh. No. 1341-42, (Paediatric) (6g/100ml bottle)
Village Bhatoli Kalan Near
EPIP-I, P.O. Barotiwala, H.O.-
174103, INDIA

231 P187 CHLORAMPHENICOL Chloramphenicol Cadila/ Zydus Health Care Capsule 250 mg POM PP E
India
232 P546 CHLORAMPHENICOL Vanmycetin FDC India Eye Drops 0.40% POM PP E
233 P14 CHLORAMPHENICOL Econochlor Alcon,Belgium Eye Drops 0.50% POM PP E
234 P15 CHLORAMPHENICOL Econochlor Alcon,Belgium Eye Ointment 0.50% POM PP E
235 P125 CHLORAMPHENICOL Beaphenicol Beacons Singapore Eye Ointment 0.50% POM PP E
236 P188 CHLORAMPHENICOL Chloramphenicol Cadila/ Zydus Health Care Tablet 250 mg POM PP E
India

MTG Division, MFDA Rec. Name: Approved Drug List

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Issue No.: 02 Rev.Date: 19.02.2019
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 237 P126 CHLORAMPHENICOL Bephenicol Beacons Singapore Eye Drops 0.30% POM PP E
238 P1197 CHLORDIAZEPOXIDE Librium Abbott Healthcare Pvt. Ltd. Tablet 10mg CONTROLLED PP E
India
239 P1196 CHLORDIAZEPOXIDE Mebrium Medopharm, India Tablet 10 mg CONTROLLED PP E
240 P1198 CHLORDIAZEPOXIDE Benpine Atlantic Lab/ India Tablet 5 mg CONTROLLED PP E
241 P2088 CHLORDIAZEPOXIDE + CLIDINIUM Librax Meda Pharma, Switzerland Tablet 5 +2.5mg CONTROLLED PP

242 P236 CHLORPHENIRAMINE + NH4CL Cofton Cipla India Oral Liquid 2mg/5ml OTC PP
243 P1428 CHLORPROMAZINE CHLORPROMAZINE Sun Pharma Laboratories Tablet 100 mg POM PP E
Ltd,India
244 P1463 CHLORPROMAZINE Chlorpromazine Rhone Poulenc Tablet 10 mg POM PP E
245 P569 CHLORPROMAZINE Chlorazine G Streuli & Co EU Suppository 25 mg POM PP E
246 P1544 CHORIONIC GONADOTROPHIN HUCOG-5000 HP Bharat Serums and Injection 5000 IU (1ml) POM PP
(HIGHLY PURIFIED I.H.) Vaccines Limited, Plot No. K-
27, Additional M.I.D.C.,
Ambernath € -421 501,
INDIA
247 P1098 CHYMOTRYPSIN Alfapsin Lyka BDR India Tablet 5.775 mg POM PP
248 P877 CICLOPIROX OLAMINE Batrafen Hoechst Marion Roussel Cream 10mg/g in 15g POM PP
India/Aventis Pharma

249 P1559 CIMETIDINE Tagamet SKB, Pakistan Injection 400 mg/2 ml POM PP
250 P1560 CIMETIDINE Tagamet SKB, Pakistan Tablet 200 mg POM PP
251 P2054 CINNARIZINE IP Cinzan-25 DT FDC Limited At: Plot No. L Uncoated 25 mg POM PP E
121 B Verna Industrial Dispersible Tablet
Estate, Verna Salcete Goa
403 722, INDIA

252 P931 CINNARIZINE IP Stugeron Forte Encore Healthcare Pvt. Ltd. Uncoated Tablet 75 mg POM PP
Plot No. D-5, MIDC, Paithan -
431 148, INDIA (for Johnson
& Johnson)

253 P246 CIPROFLOXACIN Ciplox Cipla India Eye Ointment 0.30% POM PP E
254 P522 CIPROFLOXACIN HYDROCHLORIDE Zoxan FDC Limited At: T-68 Eye Ointment 0.3% w/w + 0.5% POM PP E
IP + CHLORBUTOL (AS M.I.D.C. Tarapur Boisar, w/w (5g tube)
PRESERVATIVE) IP Dist. Thane 401 506, INDIA

255 P2826 CIPROFLOXACIN IP + SODIUM Fresoflox Fresenius Kabi India Pvt. Injection 0.2g + 0.9g per 100ml POM PP E Each Shipment should be
CHLORIDE IP Limited. A-3, MIDC, accompanied by the batch
Ranjangaon Ganpati, Tal. certificates
Shirur, Dist. Pune 412 220,
INDIA
256 P189 CISAPRIDE Cisapro Cadila/ Zydus Health Care Tablet 10 mg POM PP
India
257 P1607 CISAPRIDE Unipride Torrent, India Tablet 10 mg POM PP

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 258 P1236 CLEMASTINE Tavegyl Novartis, India Tablet 1 mg POM PP
259 P1265 CLEMASTINE Tandegyl Novartis, Pakistan Tablet 2 mg POM PP
260 P1238 CLEMASTINE Tavegyl Novartis, India Oral Drops 500 mcg/5ml POM PP
261 P1266 CLEMASTINE Tandegyl Novartis, Pakistan Oral Drops 250 mcg/5ml POM PP
262 P1237 CLEMASTINE Tavegyl Novartis, India Tablet 2 mg POM PP
263 P1264 CLEMASTINE (AS HYDROGEN Tandegyl Novartis Pharma (Pakistan) Tablet 1 mg POM PP
FUMARATE) USP Ltd. Petaro Road, Jamshoro

264 P2084 CLOBAZAM Frisium Aventis Pharma Ltd Tablet 20 mg CONTROLLED PP

265 P2085 CLOBAZAM Lobazam Sun pharmaceuticals, India Tablet 5mg CONTROLLED PP

266 P2086 CLOBAZAM Lobazam Sun pharmaceuticals, India Tablet 10mg CONTROLLED PP

267 P2089 CLOBAZAM Lobazam Sun pharmaceuticals, India Tablet 20 mg CONTROLLED PP

268 P776 CLOBETASOL Dermovate GlaxoSmithKline, Pakistan Cream 0.05% in 10g POM PP E

269 P724 CLOBETASOL Eumosone GlaxoSmithKline, India Cream 0.05% POM PP

270 P664 CLOBETASOL Dermovate GlaxoSmithKline, Srilanka Cream 0.05% in 5g POM PP E

271 P666 CLOBETASOL Dermovate GlaxoSmithKline, Pakistan Ointment 0.05% in 10g POM PP E

272 P665 CLOBETASOL Dermovate GlaxoSmithKline, Topical Ointment 0.05% 5g POM PP E

Pakistan/Srilanka
273 P1385 CLOBETASOL Exel Sun Pharmaceutical Cream 0.05% in 15g POM PP E
Industries, India
274 P777 CLOBETASOL Dermovate GlaxoSmithKline, SriLanka Topical Ointment 0.05% 15g POM PP E

275 P1089 CLOBETASOL Dermotyl Lyka BDR India Cream 0.05% POM PP E
276 P723 CLOBETASOL PROPIONATE IP + Tenovate M Encube Ethicals Pvt. Ltd. At: Cream 0.05% w/w + 2.0 % POM PP
MICONAZOLE NITRATE IP + Plot No. C-1, Madkaim w/w + 0.1 % w/w
CHLOROCRESOL (AS Industrial Estate, Madkaim, (15g tube)
PRESERVATIVE) IP Post Mardol, Ponda, Goa -
403 404, INDIA (MARKETED
BY GSK)

277 P249 CLOMIFENE Fertomid Cipla India Tablet 100MG POM PP E

278 P248 CLOMIFENE CITRATE IP Fertomid-50 CIPLA LTD. Kumrek, Rangpo Uncoated Tablet 50 mg POM PP E
Sikkim 737 132, INDIA

279 P247 CLOMIFENE CITRATE IP Fertomid-25 CIPLA LTD. Kumrek, Rangpo Uncoated Tablet 25 mg POM PP E
Sikkim 737 132, INDIA

280 P1252 CLOMIPRAMINE Anafranil Novartis, India/Pakistan Tablet 10 mg POM PP E

MTG Division, MFDA Rec. Name: Approved Drug List

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 281 P1253 CLOMIPRAMINE Anafranil Novartis, India/Pakistan Tablet 25 mg POM PP E

282 P1880 CLOMIPRAMINE HYDROCHLORIDE Clomfranil 25 Novartis Pharma (Pakistan) Sugar coated 25 mg POM PP E
Limited, Petaro Road, tablet
Jamshoro, Pakistan

283 P2064 CLONAZEPAM Rivotril Roche Farma,SA Spain Tablet 0.5 mg CONTROLLED PP
284 P2066 CLONAZEPAM Rivotril Roche Farma,SA Spain Tablet 2 mg CONTROLLED PP
285 P2065 CLONAZEPAM Rivotril Roche Farma,SA Spain Tablet 1 mg CONTROLLED PP
286 P580 CLONIDINE Catapress Cadila Health Care Tablet 150 mcg POM PP
Ltd/German Remedies
287 P1530 CLORAZEPATE DIPOTASSIUM Tranxene Searle, Pakistan Capsule 10 mg CONTROLLED PP
288 P1531 CLORAZEPATE DIPOTASSIUM Tranxene Searle, Pakistan Capsule 5 mg CONTROLLED PP
289 P1091 CLOTRIMAZOLE Imidil Lyka BDR India Cream 1% in 15g POM PP E
290 P1092 CLOTRIMAZOLE Imidil Lyka BDR India Powder 1% in 30g POM PP E
291 P1093 CLOTRIMAZOLE Imidil Lyka BDR India Solution 1% w/v in 15ml POM PP E
292 P813 CLOTRIMAZOLE Candid Glenmark , India Topical Ointment 1% POM PP E

293 P820 CLOTRIMAZOLE Candid V 6 Glenmark , India Tablet (Vaginal) 200 mg POM PP E

294 P1090 CLOTRIMAZOLE Imidil Lyka BDR India Tablet (Vaginal) 100 mg POM PP E

295 P834 CLOTRIMAZOLE Nycil Heinz India Powder 1% OTC PP

296 P810 CLOTRIMAZOLE + ANHYDROUS Candid-B Glenmark Pharmaceuticals Lotion 1% + 0.025%(15ml) POM PP
BECLOMETASONE DIPROPIONATE Ltd. B/2, Mahalaxmi
Chambers, 22, Bhulabhai
Desai Road, Bombay - 400
026 (INDIA)

297 P809 CLOTRIMAZOLE USP + Candid-B Glenmark Pharmaceuticals Cream 1% + 0.025% ( 15g) POM PP
BECLOMETASONE DIPROPIONATE Ltd. B/2, Mahalaxmi
BP Chambers, 22, Bhulabhai
Desai Road, Bombay - 400
026 (INDIA)

298 P835 CLOXACILLIN Cloxacillin 250 Hemas, Sri Lanka Capsule 250 mg POM PP E
299 P836 CLOXACILLIN Decalox Hemas, Sri Lanka Capsule 250 mg POM PP E
300 P1095 CLOXACILLIN Cloxacillin Lyka BDR India Capsule 250 mg POM PP E
301 P1096 CLOXACILLIN Klox Lyka BDR India Capsule 250mg POM PP E
302 P1561 CLOXACILLIN Orbenin SKB, Pakistan Capsule 250 mg POM PP E
303 P1097 CLOXACILLIN Klox Lyka BDR India Oral Liquid 125mg/5ml in 40 ml POM PP E

304 P1094 CLOXACILLIN Clox Lyka BDR India Oral Liquid 125 mg POM PP E

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 17 of 52 Authorized by:DG,MFDA
 305 P1429 CODEINE Phensedyl Abbott Oral Liquid 10mg + 4mg/5ml CONTROLLED PP E
PHOSPHATE+CHLORPHENIRAMINE

306 P71 CODEINE Mits Linctus Codeine Astra Zeneca India Oral Liquid 10mg + 4mg/5ml CONTROLLED PP E
PHOSPHATE+CHLORPHENIRAMINE

307 P1267 CO-DERGOCRINE MESILATE Hydergin Novartis, Pakistan Tablet 1.5mg POM PP
308 P2823 COMPOUND SODIUM LACTATE RL Fresenius Kabi India Pvt. Injection 0.32g + 0.60g + POM PP E Each Shipment should be
(RINGER-LACTATE) + SODIUM Limited. A-3, MIDC, 0.040g + 0.027g accompanied by the batch
CHLORIDE BP + POTASSIUM Ranjangaon Ganpati, Tal. (500ml) certificates
CHLORIDE BP + CALCIUM Shirur, Dist. Pune 412 220,
CHLORIDE DIHYDRATE BP INDIA.
309 P1751 CONJUGATED ESTROGENS USP Premarin Pfizer Ireland Sugar coated 0.625 mg POM PP E
Pharmaceuticals, tablet
Newbridge, Co. Kildare,
IRELAND (Marketed by
Wyeth Limited)
310 P615 CO-TRIMOXAZOLE Septran P GlaxoSmithKline, India Tablet 120mg POM PP E
(sulfamethoxazole +
trimethoprim)
311 P1292 CROTAMITON Eurax Novartis, UK Cream 10% OTC PP E
312 P1293 CROTAMITON Eurax Novartis, UK Lotion 10% OTC PP E
313 P250 CYCLIZINE Medazine T Cipla India Tablet 50mg POM PP
314 P1268 CYCLOSPORIN Sandimmun Neoral Catalent Germany Eberbach Soft Gelatin 100mg POM PP E
GmbH, Eberbach/Baden, Capsule
Germany (For Novartis
Pharma AG, Basle,
Switzerland)

315 P1269 CYCLOSPORIN Sandimmun Neoral Catalent Germany Eberbach Soft Gelatin 25mg POM PP E
GmbH, Eberbach/Baden, Capsule
Germany (For Novartis
Pharma AG, Basle,
Switzerland)

316 P1244 CYCLOSPORIN Sandimmun Neoral Catalent Germany Eberbach Injection 100mg/ml in 50ml POM PP E
GmbH/ Novartis Pharma
AG, Switzerland

317 P1239 CYCLOSPORIN Sandimmun Conc 1ml Novartis, India Injection 50mg/ml 1ml POM PP E
318 P1240 CYCLOSPORIN Sandimmun Conc 5ml Novartis, India Injection 50mg/ml 5ml POM PP E
319 P1270 CYCLOSPORIN Sandimmun Novartis, Pakistan Capsule 10mg POM PP E
320 P213 CYPROHEPTADINE Cydine Cosme Remedies / CFL Oral Liquid 2mg/5ml POM PP
Pharmaceutical India/
Lundbeck India
321 P1182 CYPROHEPTADINE Periactin MSD, Pakistan Tablet 4 mg POM PP

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 18 of 52 Authorized by:DG,MFDA
 322 P1181 CYPROHEPTADINE Periactin MSD, Pakistan Oral Liquid 2 mg/5 ml POM PP
323 P1168 CYPROHEPTADINE Practin Merind India/wochartd Tablet 4mg POM PP
324 P255 DANAZOL Danogen Cipla India Capsule 50 mg POM PP
325 P616 DAPSONE Dapsone GlaxoSmithKline, India Tablet 25mg POM PP
326 P617 DAPSONE Dapsone GlaxoSmithKline, India Tablet 50mg POM PP
327 P191 DEXAMETHASONE Dexona Cadila/ Zydus Health Care Injection 4 mg/ml POM PP E
India
328 P1170 DEXAMETHASONE Decdan Merind India/wochartd Injection 4 mg/ ml POM PP E
329 P1169 DEXAMETHASONE Decdan Merind India/wochartd Tablet 0.5 mg POM PP E
330 P1171 DEXAMETHASONE Decdan Merind India/wochartd Tablet 8 mg POM PP E
331 P878 DEXAMETHASONE ACETATE BP + Sofradex SANOFI INDIA LIMITED. Plot Cream 0.1% w/w + 1.0% POM PP
FRAMYCETIN SULPHATE IP + No. C-1, Madkaim Industrial w/w + 0.08% w/w +
METHYL PARABEN IP (AS Estate. Ponda, Goa-403 0.04% w/w in 20g
PRESERVATIVE) + PROPYL 404, INDIA
PARABEN IP (AS A PRESERVATIVE)

332 P190 DEXAMETHASONE IP Dexona Zydus Healthcare Ltd. Uncoated Tablet 0.5 mg POM PP E
Ahmedabad, India
333 P556 DEXCHLORPHENIRAMINE Polaramine Fulford India Tablet 2 mg POM PP
334 P558 DEXCHLORPHENIRAMINE Polaramine Rep Fulford India Tablet 6 mg POM PP
335 P557 DEXCHLORPHENIRAMINE Polaramine Fulford India Oral Liquid 0.5 mg/5ml POM PP
336 P2827 DEXTOANHYDROUS +POTASIUM Electorate P Fresenius Kabi, India Injection 5.0g+ 0.13g+ 0.026g+ POM PP E Each Shipment should be
CHLORIDE+DIBASIC POTASIUM 0.32g + 0.031g+ accompanied by the batch
PHOSPHATE+SODIUM 0.021 g in 100ml certificates
ACETATE+MAGNESIUM
CHLORIDE+SODIUM
METABISULPHATE.

337 P2700 DEXTRAN Microspan Claris Otsuka Pvt Ltd,India Injection 40% Restricted for PP E
Hospital use only

338 P2831 DEXTROSE ANHYDROUS IP Dextrose 25 Fresenius Kabi India Pvt. Injection (25% w/v) 25.0g in POM PP E Each Shipment should be
Limited. A-3, MIDC, 100ml accompanied by the batch
Ranjangaon Ganpati, Tal. certificates
Shirur, Dist. Pune 412 220,
India.
339 P2830 DEXTROSE ANHYDROUS IP Dextrose 5% Fresenius Kabi India Pvt. Injection 5% w/v (5.0g) in POM PP E Each Shipment should be
Limited. A-3, MIDC, 500ml accompanied by the batch
Ranjangaon Ganpati, Tal. certificates
Shirur, Dist. Pune 412 220,
India.

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 19 of 52 Authorized by:DG,MFDA
 340 P67 DIASTASE IP + PEPSIN IP Aristozyme Liquid ARISTO Pharmaceuticals Oral Liquid 50 mg + 10 mg per POM PP
Pvt. Ltd. At: Survey No.: 5ml
371, Kunbar Falia, Village:
Dabhel, Nani Daman- 396
210, DAMAN (U.T.) At: Plot
No. 208, New Industrial
Area No.:2, Mandideep,
Dist.: Raisen (M.P.), INDIA

341 P1472 DIAZEPAM Diazepam MSJ Industries, (Ceylon) Ltd Tablet 2 mg CONTROLLED PP E

342 P1387 DIAZEPAM Sedil Square Pharmaceuticals, Injection 10 mg /2 ml CONTROLLED PP E

Bangladesh

343 P1471 DIAZEPAM Diazepam MSJ Industries, (Ceylon) Ltd Tablet 10 mg CONTROLLED PP E

344 P1473 DIAZEPAM Diazepam MSJ Industries, (Ceylon) Ltd Tablet 5 mg CONTROLLED PP E

345 P1390 DIAZEPAM Diazepam Roche, UK/India Injection 10 mg CONTROLLED PP E

346 P1386 DIAZEPAM Calmpose Sun Pharmaceutical Tablet 10 mg CONTROLLED PP E
Industries, India
347 P1389 DIAZEPAM Calmpose Sun Pharmaceutical Tablet 5 mg CONTROLLED PP E
Industries, India
348 P473 DIAZEPAM Diazepam Efroze Pakistan Tablet 2 mg CONTROLLED PP E
349 P474 DIAZEPAM Diazepam Efroze Pakistan Tablet 5 mg CONTROLLED PP E
350 P1388 DIAZEPAM Calmpose Sun Pharmaceutical Oral Liquid 2 mg/5ml CONTROLLED PP E
Industries, India
351 P1289 DICLOFENAC SODIUM Voltaren Novartis, Switzerland Injection 75 mg /3 ml POM PP E
352 P620 DIETHYLCARBAMAZINE Banocide GlaxoSmithKline, India Oral Liquid 50 mg/5ml POM PP E
353 P619 DIETHYLCARBAMAZINE CITRATE IP Banocide GlaxoSmithKline Uncoated Tablet 50 mg POM PP E
Pharmaceuticals Limited, A-
10, M.I.D.C., Ambad
Pathardi Block, Nashik
422010, INDIA
354 P621 DIETHYLCARBAMAZINE CITRATE IP Banocide forte GlaxoSmithKline Uncoated Tablet 100 mg POM PP E
Pharmaceuticals Limited, At
A-10, M.I.D.C., Ambad-
Parthardi Block, Nashik
422010, INDIA

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
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 355 P618 DIETHYLCARBAMAZINE CITRATE IP Banocide GlaxoSmithKline Oral Liquid 120 mg/5ml (100ml POM PP E
Pharmaceuticals Limited, (Syrup) bottle)
At: B-249/260, Second
Stage, Peenya Industrial
Estate, bangalore 560 058,
INDIA

356 P623 DIGOXIN Lanoxin GlaxoSmithKline Uncoated Tablet 0.25 mg POM PP E

Pharmaceuticals Limited,
Dr. Annie Besant Road,
Mumbai 400 030. INDIA

357 P622 DIGOXIN Digoxin pediatric GlaxoSmithKline, India Oral Drops 0.05 mg/ml 30ml POM PP E
358 P970 DILOXANIDE Furamid Abbott India Tablet 500 mg POM PP
359 P257 DILOXANIDE + METRONIDAZOLE Dyrade M Cipla India Tablet 250mg+200mg POM PP

360 P258 DILOXANIDE + METRONIDAZOLE Dyrade M Cipla India Oral Liquid 125mg+ 100mg/5ml POM PP

361 P1609 DILTIAZEM Dilzem Torrent, India Tablet 60 mg POM PP

362 P1610 DILTIAZEM Dilzem SR Torrent, India Tablet 90 mg POM PP
363 P475 DILTIAZEM Calzem Efroze Pakistan Tablet 30 mg POM PP
364 P476 DILTIAZEM Calzem Efroze Pakistan Tablet 60 mg POM PP
365 P1608 DILTIAZEM HYDROCHLORIDE USP Dilzem-30 TORRENT Film coated tablet 30 mg POM PP
PHARMACEUTICALS LTD.
INDIA

366 P1502 DIMENHYDRINATE Dramamin RPG Life Science, India Oral Liquid 12.5 mg in 5 ml POM PP
367 P1503 DIMENHYDRINATE Dramamin RPG Life Science, India Tablet 50mg POM PP
368 P1073 DIPANTTOTHE.ALC+FUNGAL DIAST Lupizyme Lupin Laboratories Ltd, Oral Liquid 3mg+750mg+12.5mg POM PP
+NICACINAM+PEPSIN +SORBITOL India +12.5mg+220mg+
+VIT. B1+ VIT. B12+VIT B2 4mg+ 4mcg+ 0.5mg
in 5ml
369 P1061 DIPHENHYDRAMINE + AMONIUM Lupihist Lupin Laboratories Ltd, Oral Liquid 15 mg+150 mg(IP) + POM PP
CHLORIDE + SODIUM CITRATE India 85 mg (IP) in 5ml

370 P581 DIPYRIDAMOLE Persantin Cadila Health Care Tablet 100 mg POM PP
Ltd/German Remedies
371 P582 DIPYRIDAMOLE Persantin Cadila Health Care Tablet 25 mg POM PP
Ltd/German Remedies
372 P1164 DIPYRIDAMOLE Persantin Merck Marker, Pakistan Tablet 25 mg POM PP
373 P4064 DISODIUM HYDROGEN CITRATE Citralka Pfizer Limited / India Oral liquid 1.53g/5ml POM PP

374 P1504 DISOPYRAMIDE Norpace RPG Life Science, India Capsule 100mg POM PP
375 P159 DISTILLED WITCH HAZEL Optrex Reckitt Benckiser Eye Drops 13% OTC PP
Healthcare

MTG Division, MFDA Rec. Name: Approved Drug List

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 376 P1882 DISTILLED WITCH HAZEL + Optrex Reckitt Benckiser Eye Lotion 13.0% v/v + 0.005% OTC PP
BENZALKONIUM CHLORIDE Healthcare International w/v
Ltd. Thane Road,
Nottingham, NG90 2DB, UK

377 P733 DITHRANOL + SALICYLIC ACID + Derobin GlaxoSmithKline, India Ointment 1.15%+ 1.15%+5.3% POM PP E
COLTAR SOLUTION
378 P4197 DL-ALPHA TOCOPHERYL ACETATE Oxigard Glenmark, India capsule 25 mg + 30% +10 mg OTC PP
(VITAMIN E) , BETA CAROTENE + 100 mg + 75 mcg+
DISPERSION , ASCORBIC ACID , 1.5 mg+ 27.5 mg
SELENIUM, COPPER ,MANGANEE ,
ZINC
379 P644 DM + TRIPROLIDINE HCL + Actifed DM GlaxoSmithKline, Pakistan Oral Liquid 10mg + 1.25mg + CONTROLLED PP E
PSEUDOEPHEDRINE 30mg in 5ml
380 P753 DM + TRIPROLIDINE HCL + Actifed DM GlaxoSmithKline, SriLanka Oral Liquid 10mg + 1.25mg + CONTROLLED PP E
PSEUDOEPHEDRINE 30mg in 5 ml
381 P1391 DOBUTAMINE HYDROCHLORIDE IP Dotamin NEON LABORATORIES Injection 50mg / ml POM PP E
LIMITED. 28, Mahal Ind. Est. (250mg/5ml
M. Caves Rd. Andheri collectively)
(East), Mumbai - 400 093,
INDIA

382 P1641 DOPAMINE HYDROCHLORIDE IP Domin NEON LABORATORIES Injection 40mg / ml POM PP E
LIMITED. 28, Mahal Ind. Est. (200mg/5ml
M. Caves Rd. Andheri collectively)
(East), Mumbai - 400 093,
INDIA

383 P324 DOXEPIN HCL Noctaderm Sun Pharmaceutical Cream 5% POM PP

Industries, India
384 P1564 DRIED FERROUS SULFATE + FOLIC Fefol Glaxo Smithkline, Pakistan Capsule 150mg+0.5 mg OTC PP E
ACID
385 P228 ECONAZOLE NITRATE Pevaryl Cream Cilag Ltd Cream 1% POM PP
386 P227 ECONAZOLE NITRATE Gyno-Pevaryl 150 Cilag Ltd Pessaries 150mg POM PP
387 P1184 ENALAPRIL Renitec MSD, Pakistan Tablet 20 mg POM PP E
388 P445 ENALAPRIL Myoace Merck Ltd, India Tablet 10mg POM PP E
389 P193 ENALAPRIL MALEATE IP Envas 10 Cadila Pharmaceuticals Tablet 10 mg POM PP E
Limited, Industrial Growth
Center, SIDCO, Samba-184
121, State of J & K, INDIA

390 P1786 ERYTHROMYCIN Erysol Xepa Soul Pattinson Powder for 200 mg/ml POM PP
Topical Solution

MTG Division, MFDA Rec. Name: Approved Drug List

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 391 P2 ERYTHROMYCIN Eryderm Abbott Pakistan Topical Solution 2% 50ml POM PP

392 P1752 ESTROGENS Premarin Wyeth, India Tablet 1.25mg POM PP E

393 P1767 ESTROGENS Premarin Wyeth Lederle, India Tablet 0.625mg POM PP E
394 P1768 ESTROGENS Premarin Wyeth Lederle, India Tablet 1.25mg POM PP E
395 P1753 ETHINYL ESTRADIOL + Ovral Wyeth, India Tablet 0.05mg + 0.25mg POM PP E
LEVONOGESTREL
396 P1769 ETHINYL ESTRADIOL + Nordette Wyeth Lederle, Pakistan Tablet 0.03mg + 0.15mg POM PP E
LEVONOGESTREL
397 P1741 ETHINYL ESTRADIOL + Trinordiol Wyeth Ayerst, SriLanka Tablet 50mcg+50mcg POM PP E
LEVONOGESTREL
398 P583 ETOFYLLINE+THEOPHYLLINE Deriphyllin Cadila Zydus Health Care Oral Liquid 46.5 + 14 mg/ 5 ml POM PP E
,India
399 P586 ETOPHYLLINE IP + THEOPHYLLINE Deriphyllin® retard 150 Zydus Healthcare Ltd., Film coated 115 mg + 35 mg POM PP E
IP INDIA prolonged
released tablet

400 P585 ETOPHYLLINE THEOPHYLLINE IP + Deriphyllin retard 300 Zydus Healthcare, N. H. No. Film coated 231 mg + 69 mg POM PP E
THEOPHYLLINE HYDRATE IP 31A, Majhitar, Rangpo, East prolonged
Sikkim - 737 132, INDIA released tablet

401 P584 ETOPHYLLINE THEOPHYLLINE IP + Deriphyllin Zydus Healthcare, N. H. No. Uncoated Tablet 77 mg + 23 mg POM PP E
THEOPHYLLINE HYDRATE IP 31A, Majhitar, Rangpo, East
Sikkim - 737 132, INDIA

402 P1931 EVENING PRIMROSE OIL Primosa 1000 Universal Medicare Pvt. Soft Gelatin 1000 mg OTC PP
Ltd., Capsulation Premises, Capsule
Deonar, Sion Trombay
Road, Mumbai, At: Plot no.
811, G.I.D.C., Sarigam,
District Valsad, Gujarat -
396 155, INDIA

403 P1218 EYE COMBINATION Vital Eyes Novartis Cibavision, Eye Drops OTC PP
Pakistan
404 P1611 FAMOTIDINE Topcid Torrent, India Tablet 20 mg POM PP
405 P1612 FAMOTIDINE Topcid Torrent, India Tablet 40 mg POM PP
406 P1114 FENTANYL Fentanyl Martindale, UK Injection 50 mcg /ml CONTROLLED PP E
407 P196 FERRIC AMMONIUM CITRATE + Haemup Oral liquid Cadila/ Zydus Health Care Oral Liquid 160 mg(IP) + 0.5 mg POM PP E
FOLIC ACID + CYANOCOBALAMINE India (IP) +7.5 mcg(IP) + 30
+ CUPRIC SULFATE mcg (USP) in 15 ml

408 P434 FINASTERIDE Finast Dr Reddys Laboratories Tablet 5 mg POM PP E

India
409 P3221 FLUCINOLONE + NEOMYCIN Flucort N Glenmark , India Cream 0.025% (BP)+ 0.5% POM PP
(BP) in 15 g

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 23 of 52 Authorized by:DG,MFDA
 410 P1102 FLUCINOLONE + NEOMYCIN Flucort N Glenmark , India Cream 0.025% (BP) + POM PP
0.5%(BP) in 5 g
411 P829 FLUCINOLONE + NEOMYCIN Flucort N Gracewell, India Cream 0.025%(BP) + POM PP
0.5%(BP)
412 P1395 FLUCINOLONE + NEOMYCIN Luci N Sun Pharmaceutical Cream 0.025%+1%(eq. to POM PP
Industries, India 0.7%)
413 P1396 FLUCINOLONE + NEOMYCIN Luci N Sun Pharmaceutical Ointment 0.025%+1%(eq. to POM PP
Industries, India 0.7%)
414 P524 FLUCONAZOLE Zocon FDC India Eye Drops 0.30% POM PP E
415 P526 FLUCONAZOLE Zocon FDC India Tablet 200 mg POM PP E
416 P527 FLUCONAZOLE Zocon FDC India Tablet 50 mg POM PP E
417 P263 FLUCONAZOLE IP Forcan-200 CIPLA LTD. Kumrek, Rangpo Uncoated Tablet 200 mg POM PP E
Sikkim 737 132, INDIA

418 P264 FLUCONAZOLE IP Forcan-50 CIPLA LTD. Kumrek, Rangpo Uncoated Tablet 50 mg POM PP E
Sikkim 737 132, INDIA

419 P1613 FLUNARIZINE Nomigrain Torrent, India Tablet 5 mg POM PP

420 P528 FLUNARIZINE DIHYDROCHLORIDE Flunarin FDC Limited, At: Plot No. Uncoated Tablet 10 mg POM PP
BP L1218 Varna Industrial
Estate Varna salcote Goa
403 722, INDIA

421 P529 FLUNARIZINE DIHYDROCHLORIDE Flunarin FDC Limited, At: Plot No. Uncoated Tablet 5 mg POM PP
BP L1218 Varna Industrial
Estate Varna salcote Goa
403 722, INDIA

422 P1100 FLUOCINOLONE Flucort Glenmark , India Lotion POM PP

423 P822 FLUOCINOLONE Supricort Glenmark , India Ointment 5gm POM PP ADK Company PvtLtd
424 P1392 FLUOCINOLONE Luci Sun Pharmaceutical Cream 0.03% POM PP
Industries, India
425 P828 FLUOCINOLONE + Flucort C Gracewell, India Cream 0.01% (BP) + 1%(USP) POM PP
CICLOPIROXOLAMINE
426 P1101 FLUOCINOLONE + QLIOQUINOL Flucort C Glenmark , India Cream 0.01% (BP) 1%(USP) POM PP
in 5 g
427 P3220 FLUOCINOLONE ACETONIDE IP + Flucort-C Glenmark Pharmaceuticals Cream 0.01% w/w + 1.0% POM PP
CICLOPIROX OLAMINE USP + Ltd., (Unit-II), Village w/w + 0.2% w/w +
(METHYLPARABEN IP + Bhattanwala, P.O. Rajpura, 0.02% w/w (20g
PROPYLPARABEN IP AS Nalagarth, Distt. Solan tube)
PRESERVATIVE) (H.P.)-174101., INDIA

428 P1220 FLUOROMETHOLONE + Infectoflam Novartis Cibavision, Eye Drops 1mg +3mg in 5ml POM PP
GENTAMICIN Pakistan

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Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 24 of 52 Authorized by:DG,MFDA
 429 P1221 FLUOROMETHOLONE + Infectoflam Novartis Cibavision, Eye Ointment 1mg +3mg in 4 g POM PP
GENTAMICIN Pakistan
430 P136 FLUOROURACIL Fluracil Biochem India Capsule 250 mg POM PP
431 P137 FLUOROURACIL Fluracil Biochem India Injection 500 mg / 10ml POM PP
432 P138 FLUOROURACIL Fluracil Biochem India Injection 250 mg / 5 ml POM PP
433 P179 FLUOXETINE Fludac Cadila/ Zydus Health Care Capsule 20mg POM PP E
India
434 P1614 FLUOXETINE Oxedep Torrent, India Capsule 20 mg POM PP E
435 P178 FLUOXETINE Fludac Cadila/ Zydus Health Care Capsule 10 mg POM PP E
India
436 P180 FLUOXETINE Fludac Cadila/ Zydus Health Care Oral Liquid 20mg/5ml POM PP E
India
437 P214 FLUPENTHIXOL Fluanxol Cosme Remedies / CFL Tablet 0.5 mg POM PP E
Pharmaceutical India/
Lundbeck India
438 P218 FLUPENTHIXOL Fluanxol depot Cosme Remedies / CFL Injection 40mg/2ml POM PP E
Pharmaceutical India/
Lundbeck India
439 P215 FLUPENTHIXOL Fluanxol Cosme Remedies / CFL Tablet 3 mg POM PP E
Pharmaceutical India/
Lundbeck India
440 P216 FLUPENTHIXOL Fluanxol Cosme Remedies / CFL Tablet 1 mg POM PP E
Pharmaceutical India/
Lundbeck India
441 P217 FLUPENTHIXOL DECANOATE BP Fluanxol Depot Lundbeck India Pvt. Ltd. At: Injection 20mg/ml (1 ampoule POM PP E
54/1, Boodhihal, of 1 ml)
Nelamangala Taluk,
Bangalore - 562 123, INDIA

442 P883 FRAMYCETIN Soframycin Aventis Pharma Ltd Eye Drops 0.50% POM PP E
443 P884 FRAMYCETIN + DEXAMETHASONE Sofracort Aventis Pharma Ltd Ear/Eye Drops 5mg +0.5mg POM PP

444 P882 FRAMYCETIN SULPHATE BP Sufre tulle Dr. Sethi Pharma Industries Medicated 1% POM PP E
Burewala Road, Dressing
Chichawatni, PAKISTAN

445 P881 FRAMYCETIN SULPHATE IP Soframycin SANOFI INDIA LIMITED. Plot Skin Cream 1% POM PP E
No. C-1, Madkaim Ind.
Estate. Ponda, Goa-403
404, INDIA
446 P885 FRUSEMIDE Lasix Sanofi India Ltd Injection 10 mg/ml POM PP E
447 P886 FRUSEMIDE Lasix Sanofi India Ltd Tablet 40 mg POM PP E
448 P887 FRUSEMIDE + SPIRONOLACTONE Lasilactone-100 Aventis Pharma Ltd Tablet 20mg+100mg POM PP E

449 P888 FRUSEMIDE IP + Lasilactone 50 Sanofi India Limited, India Film coated Tablet 20 mg + 50 mg POM PP E
SPIRONOLACTONE IP

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 25 of 52 Authorized by:DG,MFDA
 450 P726 FURAZOLIDONE Furoxone GlaxoSmithKline, India Oral Liquid 25 mg/5 ml POM PP

451 P725 FURAZOLIDONE BP Furoxone GlaxoSmithKline Pakistan Tablet 100 mg POM PP

Limited, F/268, S.I.T.E.,
Karachi, PAKISTAN

452 P1549 FUSAFUNGINE Locabiotal Servier Les Laboratories Nasal Spray 1% POM PP

453 P1049 FUSIDIC ACID PH. EUR. + Fucicort LEO Pharmaceutical Cream 20 mg + 1 mg in 15g POM PP
BETAMETHASONE PH. EUR. Products Ballerup -
Denmark
454 P1787 GAMMA BENZENE HEXACHLORIDE Kellis Xepa Soul Pattinson Topical Solution 0.20% POM PP

455 P435 GAMMA LINEOLIC ACID GLA 120 Dr Reddys Laboratories Capsule 120mg POM PP
India
456 P1200 GENTAMICIN Genticyn Abbott/Nitin Lifesciences Injection 20 mg / 2 ml POM PP E
Ltd
457 P1865 GENTAMICIN Lupigenta Lupin Laboratories Ltd, Injection 40mg/ml POM PP E
India
458 P1103 GENTAMICIN Lyramycin Lyka BDR India Cream 15g POM PP E
459 P530 GENTAMICIN Bactigen FDC India Eye Drops 0.30% POM PP E
460 P1223 GENTAMICIN Dispagent Novartis Cibavision, Eye Drops 1 mg/ml POM PP E
Pakistan
461 P1104 GENTAMICIN Lyramycin 10 Lyka BDR India Injection 10 mg/ml POM PP E
462 P1105 GENTAMICIN Lyramycin 40 Lyka BDR India Injection 40 mg/ml POM PP E
463 P269 GENTAMICIN Gentacip Cipla India Injection 80mg POM PP E
464 P559 GENTAMICIN Garamycin Fulford India Injection 20 mg /2ml POM PP E
465 P561 GENTAMICIN Garamycin E/E Fulford India Ear/Eye Drops 3 mg /ml POM PP E
466 P1225 GENTAMICIN Dispagent Novartis Cibavision, Eye Ointment 1 mg/ml POM PP E
Pakistan
467 P560 GENTAMICIN Garamycin Fulford India Injection 80 mg /2ml POM PP E
468 P1201 GENTAMICIN + HYDROCORTISONE Genticyn HC Abbott Ear/Eye Drops 0.3% w/v + 1% w/v POM PP

469 P1199 GENTAMYCIN SULPHATE Genticyn Akums Drugs and Eye Drops 0.3% w/v (10ml POM PP E
Pharmaceuticals Ltd, India bottle)

470 P890 GLIBENCLAMIDE Semi Daonil Aventis Pharma Ltd Tablet 2.5 mg POM PP E
471 P477 GLIBENCLAMIDE Semi Glicon Efroze Pakistan Tablet 2.5 mg POM PP E
472 P889 GLIBENCLAMIDE IP Daonil SANOFI INDIA LIMITED, Plot Uncoated Tablet 5 mg POM PP E
No. 3501, 3503-15, 6310 B-
14, G.I.D.C. Estate,
Ankleshwar 393 002., INDIA

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 26 of 52 Authorized by:DG,MFDA
 473 P1536 GLICLAZIDE BP Diamicron Servier Research & Tablet 80 mg POM PP E
Pharmaceuticals (Pakistan)
Pvt. Ltd. 9-km Sheikhupura
Road, Lahore Pakistan

474 P1361 GLUCOSAMINE SULPHATE Cartigen Pharmed Capsule 500mg OTC PP

475 P1514 GLYCERIN BP + SODIUM Glycerin Sapient Pharma, 123/S Suppository 70% + 2% + 8% + 20% OTC PP
CARBONATE + STEARIC ACID + Industrial Area Kot Lakhpat
WATER Lahore-PAKISTAN

476 P3399 GLYCERINE Glycerine Southern Edible Oil Solution 500 ml OTC PP
Industries,Malaysia
477 P626 GLYCERYL TRINITRATE Angised GlaxoSmithKline, India Tablet 0.5 mg POM PP E
(Sublingual)
478 P1254 GLYCERYL TRINITRATE Nitroderm TTS Novartis, India Transdermal 5 mg POM PP E
system
479 P1258 GLYCERYL TRINITRATE Nitroderm TTS Novartis, India Transdermal 10 mg/patch POM PP E
system
480 P1280 GLYCERYL TRINITRATE Nitroderm TTS Novartis, Pakistan Transdermal 10 mg/patch POM PP E
system
481 P667 GLYCERYL TRINITRATE BP Angised GlaxoSmithKline Pakistan Tablet 0.5 mg POM PP E
Limited, F/268, S.I.T.E., (Sublingual)
Karachi, PAKISTAN

482 P727 GRISEOFULVIN Grisovin GlaxoSmithKline, India Tablet 125 mg POM PP E

483 P728 GUAIPHENESIN + SALBUTAMOL Ventorlin Expectorant GlaxoSmithKline, India Oral Liquid 100mg + 2mg in 10ml POM PP

484 P1202 GUAIPHENESIN + SALBUTAMOL Deletus A Abbott Oral Liquid 100mg+2mg/10ml POM PP

485 P3114 HAEMOCOAGULASE ( Haemaccel Abbott Healthcare Private Injection 3.5 gm/500 ml Restricted for PP
Polygeline) Limited, India Hospital/Instituti
onal use only

486 P928 HALOPERIDOL Halopidol J&J, India Tablet 2 mg POM PP E

487 P929 HALOPERIDOL Halopidol J&J, India Tablet 5 mg POM PP E
488 P1505 HALOPERIDOL IP Serenace RPG Life Sciences Ltd. 3102, Uncoated Tablet 0.25 mg POM PP E
G.I.D.C. Estate, Ankleshwar -
393 002, INDIA

489 P1506 HALOPERIDOL IP Serenace 1.5 RPG Life Sciences Ltd. 3102, Uncoated Tablet 1.5 mg POM PP E
G.I.D.C. Estate, Ankleshwar -
393 002, INDIA

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 27 of 52 Authorized by:DG,MFDA
 490 P1507 HALOPERIDOL IP Serenace RPG Life Sciences Ltd. 3102, Oral Liquid 2mg /ml (15ml) POM PP E
G.I.D.C. Estate, Ankleshwar -
393 002, Dist, Bharuch,
Gujarat, INDIA

491 P1509 HALOPERIDOL IP Serenace RPG Life Sciences Ltd. 3, Injection 5mg/ml POM PP E
G.I.D.C. Estate, Ankleshwar -
393 002 At 801/P, G.I.D.C.
Estate, Ankleshwar - 393
002, INDIA

492 P1508 HALOPERIDOL IP Serenace 5 RPG Life Sciences Ltd. 3102, Uncoated Tablet 5 mg POM PP E
G.I.D.C. Estate, Ankleshwar -
393 002, INDIA

493 P729 HEMATINIC Fefol - Z GlaxoSmithKline Capsule POM PP E

494 P730 HEMATINIC Fesovit GlaxoSmithKline, India Capsule POM PP E

495 P143 HEPARIN Beparin Neon Laboratories, India Injection 25000IU POM PP E

496 P144 HEPARIN Heparin Leo Biological Limited ,India Injection 5000 IU POM PP E

497 P588 HEPARIN SODIUM + ETHANOL Thrombophob Cadila Health Care Gel 200 IU (IP) + 95% 0.5 OTC PP E
Ltd/Zydus Alidac g (IP)
498 P2833 HEPARIN SODIUM IP + BENZYL Beparine Biological E. Limited, INDIA Injection 1000IU + 0.95% w/v POM PP E
ALCOHOL IP per ml (5000IU in
5ml)
499 P2834 HEPARIN SODIUM IP + BENZYL Beparine Biological E. Limited, INDIA Injection 5000IU + 0.95% w/v POM PP E
ALCOHOL IP per ml (25000IU in
5ml)
500 P3055 Hepatitis B immunoglobulin Hepatitis B CSL Behriing GmbH, Injection 200U/ml Restricted for PP E
immunoglobulin Germany Hospital use only

501 P1543 HUMAN CHORIONIC Hucog Bharat Serum and Vaccines Injection 2000 IU POM PP
GONADOTROPIN Limited,India
502 P1542 HUMAN CHORIONIC Hucog Bharat Serum and Vaccines Injection 1000 IU POM PP
GONADOTROPIN Limited, India

503 P1719 HUMAN CHORIONIC Corion Win Medicare, India Injection 1000 IU POM PP
GONADOTROPIN
504 P1721 HUMAN CHORIONIC Corion Win Medicare, India Injection 2000 IU POM PP
GONADOTROPIN
505 P1722 HUMAN CHORIONIC Corion Win Medicare, India Injection 5000 IU POM PP
GONADOTROPIN
506 P1720 HUMAN CHORIONIC Corion Win Medicare, India Injection 10000 IU POM PP
GONADOTROPIN

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 28 of 52 Authorized by:DG,MFDA
 507 P780 HYDROCORTISONE Efcortelan Cream GlaxoSmithKline, SriLanka Cream 0.5% 15g POM PP E

508 P781 HYDROCORTISONE Efcortelan Ointment GlaxoSmithKline, SriLanka Topical Ointment 0.5% 15g POM PP E

509 P874 HYDROCORTISONE + Proctosedyl Unimark Remedies/ Aventis Topical Ointment 5mg + 5mg 10mg + OTC PP E
CINCHOCAINE HYDROCHLORIDE + Pharma Limited 10mg + in 10gm
AESCULIN + FRAMYCETIN
SULPHATE
510 P945 HYDROCORTISONE + MICONAZOLE Daktacort J&J, India Cream 1% w/w + 2% w/w in POM PP
5g
511 P732 HYDROCORTISONE + Efcorlin GlaxoSmithKline, India Nasal Drops 0.02% + 0.025% in POM PP E
NAPHAZOLINE 15ml
512 P614 HYDROCORTISONE + NEOMYCIN B Neosporin H GlaxoSmithKline, India Ear Drops 10 mg + 3400 units + POM PP
+ POLYMAXIN SULPHATE 10000 units

513 P1203 HYDROQUINONE USP + Melalite 15 Mepromax Lifesciences Pvt. Cream 2% w/w + 2.5% w/w POM PP
OXYBENZONE USP + OCTINOXATE Ltd. 16, Pharmacity, + 9.0 w/w (30g tube)
USP Selaqui, Dehradun - 248
197, Uttarakhand, INDIA
(Marketed by Abbott)

514 P590 HYDROXYPROGESTERONE Proluton Depot Cadila Healthcare Limited, Injection 250mg / ml (1 ml POM PP E
CAPROATE IP Kundaim Industrial Estate, vial)
Ponda, Goa 403 401, INDIA

515 P591 HYDROXYPROGESTERONE Proluton Depot Cadila Healthcare Limited, Injection 500mg / 2 ml POM PP E
CAPROATE IP Kundaim Industrial Estate,
Ponda, Goa 403 401, INDIA

516 P272 IBUPROFEN Ibugesic Cipla India Tablet 600 mg OTC PP E

517 P983 IBUPROFEN BP Brufen Abbott Laboratories Cream 10 gm (30g tube) OTC PP E
(Pakistan) Ltd. Landhi,
Karachi, Pakistan
518 P1226 IDOXURIDINE Herpidu Novartis Cibavision, Eye Drops OTC PP
Pakistan
519 P1616 IMIPRAMINE Antidep Torrent, India Tablet 75 mg POM PP
520 P1271 IMIPRAMINE Tofranil Novartis, Pakistan Tablet 25 mg POM PP
521 P1615 IMIPRAMINE HYDROCHLORIDE IP Antidep TORRENT Tablet 25 mg POM PP
PHARMACEUTICALS LTD. 32
No. Middle Camp NH-31A,
East Ddistrict, Gangtok,
Sikkim-737 135, INDIA

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 29 of 52 Authorized by:DG,MFDA
 522 P1537 INDAPAMIDE PH. EUR. Natrilix Servier Research & Film coated tablet 2.5 mg POM PP
Pharmaceuticals (Pakistan)
Pvt. Ltd. 9-km Sheikhupura
Road, Lahore PAKISTAN

523 P1538 INDAPAMIDE PH. EUR. Natrilix SR Servier Research & Sustained-release 1.5 mg POM PP
Pharmaceuticals (Pakistan) film coated Tablet
Pvt. Ltd. 9-km Sheikhupura
Road, Lahore Pakistan

524 P974 INSULIN Insulin (P) Abbott India Injection 40 Units/ml POM PP E
525 P975 INSULIN Insulin Lente Abbott India Injection 40 Units/ml POM PP E
526 P977 INSULIN Human Monotard 40 Abbott India Injection 100/ml POM PP E
527 P1397 INSULIN Huminsulin Sun Pharma Laboratories Injection 30/70 POM PP E
Ltd,India
528 P1526 ISOCONAZOLE Travogen 35 Schering AG, Germany Tablet 1% POM PP
529 P2528 ISOFLURANE Isoflurane Raman & Weil Pvt Ltd,India Aneasthetic Gas Restricted for PP
Hospital use only

530 P1742 ISORSORBIDE DINITRATE IP Isordil-10 Ipca Laboratories Ltd., C-6, Uncoated Tablet 10 mg POM PP
Sara Ind. Estate, Chakrata
Road, Rampur, Dehradun
248 197, INDIA

531 P478 ISOSORBIDE DINITRATE Isdin Efroze Pakistan Tablet 10 mg POM PP

532 P1770 ISOSORBIDE DINITRATE Isordil Wyeth Lederle, Pakistan Tablet 10 mg POM PP

533 P1771 ISOSORBIDE DINITRATE Isordil Wyeth Lederle, Pakistan Tablet 5 mg POM PP

534 P1743 ISOSORBIDE DINITRATE IP Isordil Ipca Laboratories Ltd. C-6, Uncoated 5 mg POM PP
Sara Ind. Estate, Chakrata (Sublingual)
Road, Rampur, Dehradun Tablet
248 197, INDIA

535 P479 ISOSORBIDE MONONITRATE Monis Efroze Pakistan Tablet 20 mg POM PP E

536 P480 ISOSORBIDE MONONITRATE Monis Efroze Pakistan Tablet 40 mg POM PP E
537 P1204 ISOSORBIDE MONONITRATE IP Mono Sorbitrate Abbott Healthcare Pvt. Ltd. Tablet 10 mg POM PP E
Village Bhatauli Khurd, P.O.
Baddi-173205,Dist. Solan,
HimachalPradesh, INDIA

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 30 of 52 Authorized by:DG,MFDA
 538 P1205 ISOSORBIDE MONONITRATE IP Mono Sorbitrate Abbott Healthcare Pvt. Ltd. Tablet 20 mg POM PP E
Village Bhatauli Khurd, P.O.
Baddi-173205,Dist. Solan,
HimachalPradesh, INDIA

539 P79 ISOSORBIDE-5-MONONITRATE BP Imdur AstraZeneca Pharma India Prolonged release 30 mg POM PP E
Limited, 12th Mile, Bellary film coated tablet
Road, Bangalore-560 063,
INDIA

540 P80 ISOSORBIDE-5-MONONITRATE BP Imdur AstraZeneca Pharma India Prolonged release 60 mg POM PP E
Limited, 12th Mile, Bellary film coated tablet
Road, Bangalore-560 063,
INDIA

541 P440 ISOXSUPRINE HYDROCHLORIDE Duvadilan Abbott India Limited 801/P Injection (IM/IV) 5mg/ml POM PP
G.I.D.C. Estate, At & Post
Ankleshawar -393 002,
Gujarat, India
542 P1422 ISPAGULA Fybogel Reckkit Benchiser Powder for Oral 3.5 mg OTC PP
Healthcare UK Limited Solution
543 P1421 ISPAGULA Fibril Reckkit & Colman Powder for Oral 3.5 mg OTC PP
Solution
544 P938 KETOCONAZOLE Nizral J&J, India Tablet 200 mg POM PP
545 P1398 KETOCONAZOLE Keto Zole Sun Pharma Laboratories Tablet 200 mg POM PP
Ltd,India
546 P1307 KETOCONAZOLE IP Nizral Johnson & Johnson Cream 2% w/w (15g tube) OTC PP E
Limited., Kimwell
Biopharma Pvt. Ltd., 34th
KM, Tumkur Road, T-Begur,
Nelamangala, Bangalore
Rural - 562123, INDIA

547 P535 KETOTIFEN Tritofen FDC India Oral Liquid 1mg/5ml POM PP
548 P534 KETOTIFEN Tritofen FDC India Tablet 1 mg POM PP
549 P1617 KETOTIFEN FUMERATE Asthafen TORRENT Tablet 1 mg POM PP
PHARMACEUTICALS LTD.
India

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 31 of 52 Authorized by:DG,MFDA
 550 P1618 KETOTIFEN FUMERATE IP Asthafen TORRENT Oral Liquid 1mg/5ml (60ml) POM PP
PHARMACEUTICALS LTD. (Syrup)
Indrad-382 721, Dist.
Mehsana, INDIA, At: Plot
No. 1175, Post: Dabhasa,
Tal: Padra, Dist, Vadodara,
Gujarat 391 440, INDIA

551 P669 LAMOTRIGINE Lamictal GlaxoSmithKline, Tablet 25mg POM PP E

Pakistan/Srilanka
552 P670 LAMOTRIGINE Lamictal GlaxoSmithKline, Tablet 50mg POM PP E
Pakistan/Srilanka
553 P1621 LAMOTRIGINE IP Lamitor DT-100 TORRENT Dispersible Tablet 100 mg POM PP E
PHARMACEUTICALS LTD. 32
No. Middle Camp, NH-31A,
East District, Gangtok,
Sikkim-737 135, INDIA

554 P274 LANSOPRAZOLE Lanzol Cipla India Capsule 15mg POM PP

555 P939 LEVAMISOLE Decaris J&J, India Tablet 150 mg POM PP E
556 P940 LEVAMISOLE Decaris J&J, India Tablet 50 mg POM PP E
557 P1522 LEVONORGESTREL + Mithuri Bayer Health Care, 13342 Tablet 0.15 mg + 0.03mg POM PP E
ETHINYLESTRADIOL Berlin, Germany
558 P270 LEVOSALBUTAMOL SULPHATE IP + Asthalin Expectorant CIPLA LTD. Tarpin block, Oral Liquid 0.5mg + 50mg in 5ml POM PP
GUAIPHENESIN IP Rorathang, Sikkim 737 133 (100ml bottle)
INDIA
559 P707 LIDOCAINE USP + Shield GlaxoSmithKline Ointment 3.0% w/w + 0.25 % POM PP E
HYDROCORTISONE ACETATE IP + Pharmaceuticals Limited, At w/w + 5.0% w/w +
ZINC OXIDE IP + ALLANTOIN IP A-10, M.I.D.C., Ambad- 0.5% w/w (15g)
Parthardi Block, Nashik
422010, INDIA

560 P86 LIGNOCAINE + ADRENALIN Xylocaine with Adrenaline Quayle Dental, India Injection Dental 2% + epinephrine POM PP E
cartridge 1:80 000

561 P1313 LIQUID PARAFFIN + AGAR (NF) + LIQUID PARAFFIN + AGAR Park Davis, India/ Pfizer Oral Liquid 1.60 ml+10 mg OTC PP E
GLCERINE IP + SORBITOL (NF) + GLCERINE IP + (NF)+IP + 70% in
SORBITOL 10ml
562 P1074 LISINOPRIL Lipril 10 Lupin Laboratories Ltd, Tablet 10 mg POM PP
India
563 P1622 LISINOPRIL Listril 2.5 Torrent, India Tablet 2.5 mg POM PP
564 P1076 LISINOPRIL IP Lipril 5 Lupin LTD.,EPIP, SIDCO, Uncoated Tablet 5 mg POM PP
Kartholi, Bari Brahmana,
Jammu J&K - 181133, INDIA

MTG Division, MFDA Rec. Name: Approved Drug List

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Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 32 of 52 Authorized by:DG,MFDA
 565 P1075 LISINOPRIL IP Lipril 2.5 Lupin LTD.,EPIP, SIDCO, Uncoated Tablet 2.5 mg POM PP
Kartholi, Bari Brahmana,
Jammu J&K - 181133, INDIA

566 P1772 LORAZEPAM Ativan Wyeth Lederle, India Tablet 1 mg CONTROLLED PP E

567 P1773 LORAZEPAM Ativan Wyeth Lederle, India Tablet 2 mg CONTROLLED PP E
568 P825 LOVASTATIN Elstatin Glenmark , India Tablet 20mg POM PP
569 P275 LOVASTATIN Lovacard Cipla India Tablet 20mg POM PP
570 P1592 LOVASTATIN Recol Themis, India Tablet 10mg POM PP
571 P1593 LOVASTATIN Recol Themis, India Tablet 20mg POM PP
572 P1734 LOVASTATIN ProHDL Wockhardt, India Tablet 10mg POM PP
573 P1735 LOVASTATIN ProHDL Wockhardt, India Tablet 20mg POM PP
574 P949 MEBENDAZOLE PH. EUR. Vermox Johnson & Johnson Oral Liquid 20mg/ml (2%) (30ml OTC PP E
Pakistan (private) Limited., (Suspension) bottle)
Plot No. 10 & 25, Sector No.
20. Korangi Indstrial Area,
Karachi-74900, PAKISTAN

575 P132 MEDROXYPROGESTERONE Modus GlaxoSmithKline, India/ Tablet 10mg POM PP E

Biddle Sawyer,India

576 P483 MEFENAMIC ACID BP Mefnac Efroze Chemical Industries Oral Liquid 50mg/5ml (60ml OTC PP E
(Pvt.) Ltd., 146/23, Korangi (Suspension) bottle)
Industrial Area, Karachi-
PAKISTAN

577 P1930 MENTHOL + CAMPHOR + MENTHA Sensur Glenmark Pharmaceuticals Cream 14.0% w/w + 14.7% OTC PP
OIL + EUCALYPTUS OIL + CLOVE Ltd. 61-62, S.R. Compound, w/w + 8.0% v/w +
OIL + CINNAMON OIL + PARAFFIN Dewas Naka, Lasudia mori, 7.5% v/w + 7.8%
BASE Indore (M.P.) - 452 010. At: w/w + 2.0% v/w
35-A/4, 35-B/2, Laxmibai
Nagar, Industrial Estate,
Indore - 452 006, INDIA

578 P1154 MENTHOL B.P. + EUCALYPTUS OIL Deep heat rub The Mentholatum Co. Ltd., Cream 5.91% w/w + 1.97% OTC PP
B.P. + METHYL SALICYLATE B.P. + East Kilbride, G74 5PE, UK w/w + 12.80% w/w +
TURPENTINE OIL B.P. 1.47% w/w

579 P1496 MENTHOL+CAMPHOR + METHYL Radian B Roche, UK Lotion 2.54%(BP)+1.43%(BP OTC PP

SALICYLATE + CAPSICUM )+0.42%(BP)+ 0.05%
OLEORESIN
580 P1494 MENTHOL+CAMPHOR + METHYL Radian B Roche, UK Aerosol 2.54%(BP)+1.43%(BP OTC PP
SALICYLATE + CAPSICUM )+0.42%(BP)+ 0.05%
OLEORESIN

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 33 of 52 Authorized by:DG,MFDA
 581 P1495 MENTHOL+CAMPHOR + METHYL Radian B Roche, UK Cream 2.54%(BP)+1.43%(BP OTC PP
SALICYLATE + CAPSICUM )+0.42%(BP)+ 0.05%
OLEORESIN
582 P2572 METHADONE Methadone Biomed Limited, Newzeland Oral Liquid 5mg/ml CONTROLLED ( PP
Restricted and
only for NDA)

583 P1801 METHOTREXATE Oncotrex Biddle Sawyer Ltd India Tablet 2.5 mg POM PP

584 P1558 METHYL SALICYLATE Iodex SKB, Pakistan Spray 25% v/v OTC PP
585 P967 METHYL SALICYLATE Methyl Salicylate Sriram Chemicals/Cipali Topical Solution 25% v/v OTC PP
Pharma India

586 P1163 METHYL SALICYLATE BP + Wintogeno Merck (Private) Limited, 7, Balm 12.17% OTC PP
MENTHOL + EUCALYPTOL + Jail Road, Quetta, Pakistan.
THYMOL + OLEORESIN OF
CAPSICUM
587 P1187 METHYLDOPA Aldomet MSD Pakistan/OBS Pakistan Tablet 250 mg POM PP
( Pvt ) Ltd
588 P1207 METHYLERGOMETRINE Methergin Novartis, India Tablet 0.125 mg POM PP E
589 P1664 METHYLPREDNISOLONE ACETATE Depo Medrol Pfizer Injection 20 mg/ml POM PP E

590 P1666 METHYLPREDNISOLONE ACETATE Depo-Medrol Pfizer Belgium NV Rijksweg Injection 80 mg/2ml POM PP E
12, B- 2870 Puurs - Belgium

591 P1665 METHYLPREDNISOLONE ACETATE Depo-Medrol Pfizer Belgium NV Rijksweg Injection 40 mg/ml POM PP E
12, B- 2870 Puurs - Belgium

592 P923 METOCLOPRAMIDE Perinorm Ipca Laboratories Pvt Ltd, Injection 5 mg / ml POM PP E
India
593 P1567 METOCLOPRAMIDE Maxolon SKB, Pakistan Injection 10 mg/2ml POM PP E
594 P1566 METOCLOPRAMIDE Maxolon SKB, Pakistan Tablet 10 mg POM PP E
595 P485 METOCLOPRAMIDE Gastrolon Efroze Pakistan Tablet 10 mg POM PP E
596 P1565 METOCLOPRAMIDE Maxolon SKB, Pakistan Oral Liquid 5mg/5ml POM PP E
597 P486 METOCLOPRAMIDE Gastrolon Efroze Pakistan Oral Liquid 5mg / 5 ml POM PP E
598 P922 METOCLOPRAMIDE Perinorm Ipca Laboratories Ltd. Tablet 10 mg POM PP E
HYDROCHLORIDE IP 393/394, Melli Jorethang
Road, Gom Block,
Bharikhola, South District,
Sikkim 737 121, INDIA

599 P924 METOCLOPRAMIDE Perinorm Ipca Laboratories Ltd. Oral Liquid 5mg/5ml (30ml POM PP E
HYDROCHLORIDE IP Sejavta, Ratlam 457 002, (Syrup) bottle)
INDIA

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 34 of 52 Authorized by:DG,MFDA
 600 P278 METOCLOPRAMIDE Vominorm Cipla Ltd., India 20, INDL. Tablet 10 mg POM PP E
HYDROCHLORIDE IP Area-1, Baddi (H.P.) 173 205

601 P323 METRONIDAZOLE Metronidazole Parental Drugs(India) Ltd Injection 500 mg/100ml POM PP E Each Shipment should be
accompanied by the batch
certificates
602 P1737 METRONIDAZOLE Metronidazole Wockhardt, India Injection 500 mg POM PP E Each Shipment should be
accompanied by the batch
certificates
603 P279 METRONIDAZOLE + DILOXANIDE Dyrade M Cipla India Oral Liquid 100 mg + 125 mg/ 5 POM PP
ml
604 P1723 METRONIDAZOLE + NALIDIXIC Bactomet Win Medicare, India Suppository POM PP
ACID
605 P1431 METRONIDAZOLE BP Flagyl Sanofi Bangladesh Limited, Injection (0.5% w/v) POM PP E Each Shipment should be
Tongi, Gazipur, Bangladesh (Intravenous 500mg/100ml accompanied by the batch
Infusion) (100ml) certificates
606 P2829 METRONIDAZOLE USP Metronidazole AXA PARENTALS LTD., KH Injection 500mg (100ml) POM PP E Each Shipment should be
No. 936, 937, 939, Vill- accompanied by the batch
Kishampur-Jamipur, certificates
Roorkee-247 667, (UK)
INDIA
607 P594 MEXILETINE Mexitil Cadila Health Care Capsule 150 mg POM PP
Ltd/German Remedies
608 P595 MEXILETINE Mexitil Cadila Health Care Capsule 50 mg POM PP
Ltd/German Remedies
609 P942 MICONAZOLE Daktarin Johnson & Johnson Oral Gel 20mg (20g) POM PP E
Pakistan (private) Limited.,
Plot No. 10 & 25, Sector No.
20. Korangi Indstrial Area,
Karachi-74900

610 P1400 MICONAZOLE Zole Sun Pharmaceuticals, India Tablet (Vaginal) 200 mg POM PP E

611 P943 MICONAZOLE Gyno Dactarin J&J, India Cream 20 mg POM PP E

612 P944 MICONAZOLE NITRATE IP Daktarin Gel Kemwell Biopharma Pvt. Topical Gel 2% w/w (20g tube) POM PP E
Ltd., 34th KM, Tumkur
Road, T-Begur,
Nelamangala, Bangalore
Rural - 562 123, INDIA (For
Johson & Johnson Limited)

613 P280 MICONAZOLE NITRATE IP + Micogel CIPLA LTD. Plot No.-34, Cream 2% w/w (15g) POM PP E
CHLOROCRESOL IP Phase-IV, Bhatoli Kalan,
Baddi - 173 205, Dist. Solan
(H.P.), INDIA

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 35 of 52 Authorized by:DG,MFDA
 614 P1548 MICRONIZED, PURIFIED, Daflon 500 Servier Research & Film coated Tablet 500 mg + 450 mg + POM PP
FLAVONOID FRACTION + DIOSMIN Pharmaceuticals (Pakistan) 50 mg
+ HESPERIDIN (FLAVONOIDS) Pvt. Ltd. 9-km Sheikhupura
Road, Lahore Pakistan

615 P1758 MINOCYCLINE Cynomycin Wyeth, India Capsule 100mg POM PP

616 P437 MINOXIDIL USP Mintop Forte Dr. REDDY'S LABORATORIES Topical Solution 5% v/v (60ml bottle) POM PP
LTD., At: Plot No.: 9/5 & 6,
IDA, Uppal, Hydraabad-
500039, Telangana, INDIA

617 P436 MINOXIDIL USP Mintop Dr. REDDY'S LABORATORIES Topical Solution 2% v/v (60ml bottle) POM PP
LTD., 7-1-27, Ameerpet,
Hyderabad - 500 039, A.P.
(At: Plot No.: 9/5 & 6, IDA,
Uppal, Hydraabad-500039,
A.P.), INDIA

618 P139 MITOMYCIN IP + SODIUM Mitomycin 2 BIOCHEM Injection 2 mg POM PP

CHLORIDE IP PHARMACEUTICAL
INDUSTRIES LTD. Survey No.
48, Ringanwada Village,
Daman (U.T.) 396 210,
INDIA
619 P563 MOMETASONE FUROATE IP Elocon Torrent Pharmaceuticals Cream 1 mg (10g tube) POM PP
Ltd., India

620 P562 MOMETASONE FUROATE IP Elocon Torrent Pharmaceuticals Ointment 1 mg (10g tube) POM PP
Ltd., India

621 P1304 MONOCOMPONENT HUMAN Human Actrapid TORRENT Soluble insulin 40 IU/ml (10ml vial) POM PP E
INSULIN, BIOSYNTHETIC (R-DNA PHARMACEUTICALS LTD. injection
ORIGIN) Indrad-382 721, Dist.
Mehsana, INDIA
622 P976 MONOCOMPONENT HUMAN Human Mixtard TORRENT Biphasic isophane 40 IU/ml (10ml vial) POM PP E
INSULIN, BIOSYNTHETIC (R-DNA PHARMACEUTICALS LTD. insulin injection
ORIGIN) Indrad-382 721, Dist.
Mehsana, INDIA
623 P1116 MORPHINE Morphine Martindale, UK Injection 15 mg/ml CONTROLLED PP E
624 P1115 MORPHINE Morphine Martindale, UK Tablet 10 mg CONTROLLED PP E
625 P1401 NALIDIXIC ACID Gramoneg Sun pharmaceuticals, India Tablet 500mg POM PP

626 P1726 NALIDIXIC ACID Wintomylon Winthrop Mackwoods Ltd, Tablet 500 mg POM PP
SriLanka

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 36 of 52 Authorized by:DG,MFDA
 627 P1402 NALIDIXIC ACID Gramoneg Sun pharmaceuticals, India Oral Liquid 300mg/5ml 30ml,60 POM PP
ml
628 P198 NANDROLONE Decadeurabol Cadila/ Zydus Health Care Injection 50 mg/ml CONTROLLED PP
India
629 P909 NANDROLONE Deca Durabolin Organon India Ltd Injection 25 mg/ml CONTROLLED PP
630 P197 NANDROLONE Decadeurabol Cadila/ Zydus Health Care Injection 25 mg/ml CONTROLLED PP
India
631 P908 NANDROLONE Deca Durabolin Organon India Ltd Injection 100 mg/ml CONTROLLED PP
632 P910 NANDROLONE Durabolin Organon India Ltd Injection 25 mg/ml CONTROLLED PP
633 P1227 NAPHAZOLINE + ZINC SULFATE Oculsan Novartis Cibavision, Eye Drops 0.05 mg/ml POM PP
Pakistan
634 P2216 NAPROXEN Naprosyn Merck Limited, Pakistan Tablet 500 mg POM PP E

635 P639 NEOMYCIIN SULPHATE + Cicatrin GlaxoSmithKline, Pakistan Cream 0.5% + 250 OTC PP E
BACITRACIN ZINC L-CYSTEINE + units/gram + 0.2% +
GLYCENE + DL-THREONINE 1% + 0.1%
636 P694 NEOMYCIN + POLYMYCIN B Neosporin GlaxoSmithKline, India Topical Ointment 3400iu + 5000iu + OTC PP E
SULPHATE + BACITRACIN ZINC 400 iu
637 P640 NEOMYCIN SULPHATE + Cicatrin GlaxoSmithKline, Pakistan Powder for 3300 units per gram OTC PP E
BACITRACIN ZINC Topical use (BP)+ BP 250 units
per gram
638 P1582 NEOSTIGMINE Tilstigmin Tablets India Ltd Tablet 15mg POM PP
639 P1577 NICOUMALONE IP Acitrom 1 Abbott Healthcare Pvt. Ltd. Uncoated Tablet 1 mg POM PP
(ACENOCOUMAROL) Village Bhatauli Khurd, P.O.
Baddi-173205,Dist. Solan,
HimachalPradesh, India

640 P447 NIFEDIPINE Depicor Merck Ltd, India Capsule 10 mg POM PP E

641 P450 NIFEDIPINE Depicor SR Merck Ltd, India Tablet 20 mg POM PP E
642 P448 NIFEDIPINE Depicor Merck Ltd, India Capsule 5 mg POM PP E
643 P449 NIFEDIPINE Depicor SR Merck Ltd, India Tablet 10 mg POM PP E
644 P1623 NIFEDIPINE IP Calcigard-10 TORRENT Soft Gelatin 10 mg POM PP E
PHARMACEUTICALS LTD. Capsule
Indrad-382 721, Dist.
Mehsana, INDIA
645 P1624 NIFEDIPINE IP Calcigard-5 TORRENT Soft Gelatin 5 mg POM PP E
PHARMACEUTICALS LTD. Capsule
Indrad-382 721, Dist.
Mehsana, INDIA
646 P1625 NIFEDIPINE IP Calcigard-10 Retard TORRENT Sustained-release 10 mg POM PP E
PHARMACEUTICALS LTD. film coated Tablet
INDIA
647 P1626 NIFEDIPINE IP Calcigard Retard TORRENT Sustained-release 20 mg POM PP E
PHARMACEUTICALS LTD. film coated Tablet
INDIA

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 37 of 52 Authorized by:DG,MFDA
 648 P736 NITROFURANTOIN Furadantin GlaxoSmithKline, India Tablet 50mg POM PP

649 P737 NITROFURAZON Furacin GlaxoSmithKline, India Cream 0.2%w/w in 20g POM PP

650 P738 NITROFURAZON Furacin GlaxoSmithKline, India Topical Ointment 0.2%w/w in 25g POM PP

651 P596 NORETHISTERONE IP Primolut - N Zydus Healthcare Ltd., Uncoated Tablet 5 mg POM PP E
INDIA
652 P282 NORFLOXACIN Norflox Cipla India Eye Ointment 0.30% POM PP E
653 P1403 NORFLOXACIN Norbactin Sun pharmaceuticals, India Tablet 200 mg POM PP E

654 P1404 NORFLOXACIN Norbactin Sun pharmaceuticals, India Tablet 800 mg POM PP E

655 P284 NORFLOXACIN Norflox Cipla India Tablet 200 mg POM PP E

656 P536 NORFLOXACIN Norzen FDC India Eye Drops 0.30% POM PP E
657 P283 NORFLOXAXIN IP + LACTIC ACID Norflox-400 Pegasus Farmaco India Pvt. Film coated tablet 400mg + 120x10^6 POM PP E
BACILLUS Ltd. Village Tanda Mallu,
Kashipur Road, Ramnagar,
Dist. Nainital, Uttarakhand
244 715, INDIA (Under
Technical guidance of
CIPLA)

658 P1776 NYSTATIN Nilstat Wyeth Lederle, Pakistan Tablet 500000 units Oral POM PP E

659 P1774 NYSTATIN Nilstat Wyeth Lederle, Pakistan Oral Drops 100000 units POM PP E

660 P1744 NYSTATIN Nystatin Wyeth, India Tablet 500000 units POM PP E
661 P1745 NYSTATIN Nystatin Wyeth, India Tablet (Vaginal) 100000 units POM PP E

662 P1775 NYSTATIN Nilstat Wyeth Lederle, Pakistan Tablet (Vaginal) 500000 units POM PP E

663 P4195 OMEGA-3 FATTY ACIDS Vita EPA RP Scherer Holdings Pty ltd Capsule 1000mg OTC PP

664 P285 OMEPRAZOLE Lomac Cipla India Capsule 10 mg POM PP

665 P286 ONDANSETRON IP Emeset CIPLA LTD. Sirinagar, Oral Liquid 2mg/5ml (30ml) POM PP E ADK Company Pvt Ltd
Vijayawada 520 007 INDIA

666 P289 ONDANSETRON IP Emeset CIPLA LTD. Verna Indl. Tablet 8mg POM PP E
Estate Goa 403 722 INDIA

667 P1532 ORAL ELECTROLYTE POWDER Peditral (O.R.S.) SEARLE, The Searle Powder for Oral 3.50 gm + 1.50 gm + OTC PP E
(SODIUM CHLORIDE + POTASSIUM Company Limited, F-319, Solution (Sachets) 2.90 gm + 20.0 gm
CHLORIDE + SODIUM CITRATE + S.I.T.E., Karachi-PAKISTAN (Sachet for one litre)
DEXTROSE ANHYDROUS

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 38 of 52 Authorized by:DG,MFDA
 668 P598 ORCIPRENALINE Alupent Cadila Zydus/German Oral Liquid 10mg/5ml POM PP
Remedies India
669 P597 ORCIPRENALINE Alupent Cadila Zydus/German Tablet 10 mg POM PP
Remedies India
670 P135 ORPHENADRINE Orphiphal Biddle Sawyer Ltd India Tablet 50mg POM PP

671 P1765 OXETHAZINE (WYETH SPECS.) + Mucaine Wyeth Pakistan Limited, S- Oral liquid 10 mg + 291mg + 98 OTC PP E
ALUMINIUM HYDROXIDE USP + 33, Hawkes Bay Road, (Suspension) mg per 5 ml (120ml)
MAGNESIUM HYDROXIDE USP S.I.T.E., Karachi-PAKISTAN

672 P599 OXYFEDRINE Ildamen Cadila Zydus/German Tablet 8 mg POM PP E

Remedies India
673 P1344 OXYTETRACYCLINE Terramycin Pfizer, India Capsule 500mg POM PP
674 P1342 OXYTETRACYCLINE Terramycin Pfizer, India Capsule 250 mg POM PP
675 P1345 OXYTETRACYCLINE Tetracap Pfizer, India Capsule 250 mg POM PP
676 P1349 OXYTETRACYCLINE Oxytetracycline Pfizer, Pakistan Capsule 500 mg POM PP
677 P487 OXYTETRACYCLINE Oxylin Efroze Pakistan Capsule 250 mg POM PP
678 P100 OXYTETRACYCLINE Tetra-Cort Astron Limited, Sri Topical Ointment 30mg + 10mg POM PP
HYDROCHLORIDE BP + Lanka
HYDROCORTISONE USP
679 P879 PANCREATIN Festal N Aventis Pharma Ltd Tablet 212.50 mg POM PP
680 P627 PARACETAMOL Calpol Drops GlaxoSmithKline, India Oral Liquid 15ml 20drops/100mg OTC PP E
paracetamol

681 P129 PARADICHLOROBENZENE + Waxolve BELL PHARMA PVT. LTD. At- Ear Drops 2.0% w/v + 2.7% w/v OTC PP
BENZOCAINE IP + CHLORBUTOL IP Bell House. 73/C, K.C.I.E.L., + 5.0% w/v + 15.0%
+ TURPENTINE OIL BP Kandivli (West), Mumbai- v/v (10ml bottle)
400 067., INDIA

682 P1106 PARAFFIN (white soft paraffin + Cetraben Lyka BDR India Cream 13.2% + 10.2% in 50g OTC PP E
liquid paraffin)
683 P1107 PARAFFIN (white soft paraffin + Cetraben Lyka BDR India Cream 13.2%+ 10.2% in 75g OTC PP E
liquid paraffin)
684 P1747 PENICILLIN BENZATHINE Penidure LA 24 Wyeth, India Injection 2400000 units POM PP E
685 P1748 PENICILLIN BENZATHINE Penidure LA 6 Wyeth, India Injection 600000 units POM PP E
686 P1778 PENICILLIN BENZATHINE Penidure LA 24 Wyeth Lederle, Pakistan Injection 2400000 units POM PP E

687 P1779 PENICILLIN BENZATHINE Penidure LA 6 Wyeth Lederle, Pakistan Injection 600000 units POM PP E

688 P838 PENICILLIN BENZYL Benzyl penicillin 5Lac inj Hindustan Antibiotics, India Injection 50000 iu/5ml POM PP E

689 P839 PENICILLIN V Kaypen Hindustan Antibiotics, India Tablet 250 mg POM PP E

690 P840 PENICILLIN V Procaine pencillin Hindustan Antibiotics, India Tablet 250mg POM PP E

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 39 of 52 Authorized by:DG,MFDA
 691 P841 PENICILLIN V Procaine pencillin Hindustan Antibiotics, India Tablet 500mg POM PP E

692 P1405 PENTAZOCINE Pentazocine Sun pharmaceuticals, India Injection 30 mg CONTROLLED PP E

693 P1406 PENTAZOCINE Fortwin Sun pharmaceuticals, India Injection 30 mg CONTROLLED PP E

694 P1534 PENTAZOCINE Sosegan Searle, India Injection 30 mg / ml CONTROLLED PP E

695 P1533 PENTAZOCINE Sosegan Searle, India Tablet 25 mg CONTROLLED PP E
696 P891 PENTOXIFYLLINE Trental Sanofi India Ltd Injection 300 mg POM PP
697 P892 PENTOXIFYLLINE BP Trental 400 SANOFI INDIA LIMITED, Extended-Release 400 mg POM PP
3501, 3503-15, 6310 B-1, film coated tablet
G.I.D.C. Estate, Ankleshwar-
393 002, INDIA

698 P1117 PETHIDINE Pethidine Martindale, UK Injection 50 mg/ ml CONTROLLED PP E

699 P1333 PHENAZOPYRIDINE Pyridium 200 Akin Laboratories Pvt. Ltd. S- Sugar coated 200 mg POM PP
HYDROCHLORIDE USP 11, Phase-II, Technocrat tablet
Industrial Estate, Balanagar,
Hyderabad - 500 037, INDIA

700 P896 PHENIRAMINE Avil Sanofi Aventis Tablet 50 mg OTC PP E

701 P897 PHENIRAMINE Avil Retard Sanofi Aventis Tablet 75 mg OTC PP E
702 P893 PHENIRAMINE MALEATE BP + Avil Sanofi-aventis Pakistan Oral Liquid 15 mg/5ml (60ml OTC PP E
METHYL-4-HYDROXYBENZOATE Limited, At: Plot No 23, (Syrup) bottle)
AND PROPYL-4- Sector 22, Korangi,
HYDROXYBENZOATE AS Industrial Area, Karachi,
PRESERVATIVE Pakistan
703 P895 PHENIRAMINE MALEATE IP Avil SANOFI INDIA LIMITED, Unit- Injection 22.75 mg / ml POM PP E
III, Rampurghat road,
Paonta-Sahib, District
Sirmour, H.P-173025, INDIA

704 P894 PHENIRAMINE MALEATE IP Avil 25 SANOFI INDIA LIMITED Uncoated tablet 25 mg OTC PP E
3501, 3503 - 15, 6310 B-14,
G.I.D.C. Estate, Ankleshwar,
INDIA
705 P140 PHENOBARBITONE Phenobarbital MSJ Industries, (Ceylon) Ltd Tablet 30 mg CONTROLLED PP E

706 P2087 PHENOBARBITONE Gardenal Samrath India/ Abbott Oral Liquid 20mg/5ml CONTROLLED PP E
,India
707 P1426 PHENOBARBITONE Fenobarb Samarth Pharma Injection 200mg/ml CONTROLLED PP E
708 P142 PHENOBARBITONE Phenobarbital MSJ Industries, (Ceylon) Ltd Injection 30mg /2 ml CONTROLLED PP E

709 P141 PHENOBARBITONE Phenobarbital MSJ Industries, (Ceylon) Ltd Tablet 60 mg CONTROLLED PP E

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 40 of 52 Authorized by:DG,MFDA
 710 P571 PHENOBARBITONE Phenylbarbit G Streuli & Co EU Suppository 50 mg CONTROLLED PP E
711 P984 PHENYLEPHRINE Fenox Abbott Pakistan Nasal solution 0.25% POM PP
712 P20 PHENYLEPHRINE + ZINC Zincfrin A Alcon,Belgium Eye Drops 0.12% + 0.25% POM PP
SULPHATE+NAPHAZOLIN
713 P1334 PHENYTOIN SODIUM Dilantin Park Davis, India Tablet 100 mg POM PP E
714 P1811 PHENYTOIN SODIUM IP Epsolin Cadila Healthcare Limited, Injection 50mg/ml POM PP E
Sarkhej-Bavia N.H. No. 8A,
Moraiya, Tal: Sanand, Dist:
Ahmedabad 382 210, INDIA

715 P540 PILOCARPINE Pilocar FDC India Eye Drops 1% POM PP

716 P541 PILOCARPINE Pilocar FDC India Eye Drops 4% POM PP
717 P542 PILOCARPINE Pilocar FDC India Eye Drops 2% POM PP E
718 P21 PILOCARPINE Isopto Carpine Alcon,Belgium Eye Drops 2% POM PP E
719 P1228 PILOCARPINE Sparasacarpine Novartis Cibavision, Eye Drops 2% POM PP E
Pakistan
720 P1229 PILOCARPINE Sparasacarpine Novartis Cibavision, Eye Drops 4% POM PP E
Pakistan
721 P1628 PIRACETAM Normabrain Torrent, India Capsule 400 mg POM PP
722 P1627 PIRACETAM IP Normabrain TORRENT Oral Liquid 500mg/5ml (100ml POM PP
PHARMACEUTICALS LTD. bottle)
Indrad-382 721, Dist.
Mehsana, INDIA. At: Plot
No. 1175, Dist: Vadodara,
Gujarat 391 440, INDIA

723 P1347 PIROXICAM Dolonex Pfizer, India Capsule 20 mg POM PP

724 P1350 PIROXICAM Feldene Pfizer, Pakistan Tablet 10 mg POM PP
725 P1351 PIROXICAM Feldene Pfizer, Pakistan Tablet 20 mg POM PP
726 P200 PIROXICAM Pirofen Cadila/ Zydus Health Care Capsule 10 mg POM PP
India
727 P201 PIROXICAM Pirofen Cadila/ Zydus Health Care Capsule 20 mg POM PP
India
728 P291 PIROXICAM Pirox Cipla India Capsule 10 mg POM PP
729 P101 PIROXICAM Feldene Astron Limited, Sri Lanka Cream 0.5% 10g POM PP

730 P1346 PIROXICAM Dolonex Pfizer, India Gel 0.5% 15g POM PP
731 P1629 PIROXICAM Toldin Torrent, India Capsule 10 mg POM PP
732 P1630 PIROXICAM Toldin Torrent, India Capsule 20 mg POM PP
733 P1889 PIROXICAM + CAPSAICIN + Capsidol Sun pharmaceuticals, India Cream 0.5% w/w(IP)+ OTC PP
METHYL SALICYLATE +MENTHOL+ 0.025% w/w +
BENZYL ALCOHOL 5%w/w(IP)+ 2%
w/w+ 5% w/w per
30g

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 41 of 52 Authorized by:DG,MFDA
 734 P292 PIROXICAM IP Pirox-20 CIPLA LTD. Village Tanda Capsule 20 mg POM PP
Mallu, Kashipur Road,
Ramnagar, Dist. Nainital,
Uttarakhand 244 715, INDIA

735 P1348 PIROXICAM IP Dolonex DT Pfizer Limited, INDIA Uncoated 20 mg POM PP

Dispersible Tablet

736 P293 PIROXICAM IP + BENZYL ALCOHOL Pirox IM CIPLA LTD. E-65/66 MIDC Injection 20mg + 20mg per ml POM PP
IP Solapur 413 006, INDIA
737 P1352 PIROXICAM USP Feldene Gel Pfizer Pakistan Ltd. B-2, Topical Gel 0.5% (5 mg) (25g POM PP
S.I.T.E., Karachi, PAKISTAN tube)

738 P1550 PODOPHYLLUM RESIN BP + Podowart Akums Drugs & Topical Solution 20% w/v + 10% w/v + POM PP E
BENZOIN IP + ALOES IP + ETHANOL Pharmaceuticals Ltd. 47,48, (Paint) 2% w/v + 5% v/v +
95% IP + METHANOL Sector-6A, I.I.E., SIDCUL, 5% v/v (10ml bottle)
Haridwar-249 403,
Uttarakhand, INDIA

739 P672 POLYMIXIN B + ZINC BACITRACIN Polyfax 10gm GlaxoSmithKline, Topical Ointment 10000IU+ 500IU per POM PP E
Pakistan/Srilanka gram in 10g
740 P673 POLYMIXIN B + ZINC BACITRACIN Polyfax 20gm GlaxoSmithKline, Topical Ointment 10000IU+ 500IU per POM PP E
Pakistan/Srilanka gram in 20g
741 P671 POLYMIXIN B + ZINC BACITRACIN Polyfax GlaxoSmithKline, Eye Ointment 10000iu+ 500iu per POM PP E
Pakistan/Srilanka gram in 4g
742 P643 POLYMIXIN B SUFATE + Neosporin GlaxoSmithKline, Pakistan Eye Ointment 5000 units + 1700 POM PP
NEOMYCIN SULFATE + units + 25 units/ml in
GRAMICIDIN 15ml
743 P641 POLYMIXIN B SULPHATE + Neosporin GlaxoSmithKline, Pakistan Eye Drops 5000units(USP)+ POM PP
GRAMICIDIN + NEOMYCIN 25units+1700 units

744 P708 POLYMIXIN B SULPHATE Neosporin H GlaxoSmithKline, India Topical Ointment 10000units(USP)+ POM PP
+BACITRACIN ZINC+NEOMYCIN+ 400units(IP)+3400
HYDRCOTISONE units+ 10mg

745 P611 POLYMYXIN B SULFATE + Neosporin GlaxoSmithKline, India Powder for 5000 units(USP) + OTC PP E
BACITRACIN ZINC + NEOMYCIN Topical use 400 units (IP) + 3400
SULPHATE units in 1g
746 P642 POLYMYXIN B SULPHATE BP + Otosporin GlaxoSmithKline Pakistan Ear Drops 10000 Units + 3400 POM PP
NEOMYCIN SULPHATE BP + Limited, 35-Dockyard Road, Units + 10 mg
HYDROCORTISONE ACETATE BP West Wharf, Karachi ,
PAKISTAN

747 P1052 POTASSIUM CHLORIDE Addi- k Tab Leo, Pakistan Tablet 600mg POM PP E
748 P295 POVIDONE IODINE Cipladine Cipla India Ointment 5% OTC PP E
749 P1354 PRAZOSIN Minipress Pfizer, Pakistan Tablet 2 mg POM PP

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 42 of 52 Authorized by:DG,MFDA
 750 P1353 PRAZOSIN HYDROCHLORIDE USP Minipress Pfizer Pakistan Ltd. B-2, Tablet 1 mg POM PP
S.I.T.E., Karachi, PAKISTAN

751 P1760 PREDNISOLONE Wysolone Pfizer Limited India Dispersible Tablet 20 mg POM PP E

752 P1281 PREDNISOLONE Ultracortenol Novartis, Pakistan Eye Drops 0.50% POM PP E
753 P1230 PREDNISOLONE Ultracortenol Novartis Cibavision, Eye Ointment 5mg/g in 5g POM PP E
Pakistan
754 P1231 PREDNISOLONE Ultracortenol Novartis Cibavision, Eye Ointment 5mg/ml in 5ml POM PP E
Pakistan
755 P296 PREDNISOLONE Predinisolone Cipla India Tablet 10 mg POM PP E
756 P297 PREDNISOLONE Predinisolone Cipla India Tablet 20 mg POM PP E
757 P22 PREDNISOLONE + Isopto cetapred Alcon,Belgium Eye Drops 10%+ 0.25%(USP) POM PP E
SULPHACETAMIDE
758 P629 PROCYCLIDINE HCL Kemadrin GlaxoSmithKline, India Tablet 5mg POM PP E
759 P548 PROGESTERONE Gestone Ferring India Injection 50mg/ml POM PP E
760 P1440 PROMETHAZINE HCL + Tixylix New Abbot /Promed Oral Liquid 1.5mg+ 1.5mg + PPA POM PP
PHOLCODEINE + Laboratories in 5ml
PHENYLPROPANOLAMINE HCL
761 P1449 PROMETHAZINE THEOCLATE IP Avomine Abbott Healthcare Pvt. Ltd. Uncoated tablet 25 mg OTC PP E
Village Bhatauli Khurd, P.O.
Baddi-173205,Dist. Solan,
HimachalPradesh, INDIA

762 P1510 PROPANTHELINE BROMIDE Probanthine RPG Life Science, India Tablet 15mg POM PP
763 P23 PROPARACAINE Alcaine Alcon,Belgium Eye Drops 0.50% POM PP E
764 P696 Pseudoephedrine, Triprolidine Actifed GlaxoSmithKline Tablet CONTROLLED PP E

765 P1761 PSORALEN Manaderm Wyeth, India Tablet 10 mg POM PP E

766 P925 PYRANTEL PAMOATE Nemocid Ipca Laboratories Pvt Ltd, Tablet 250 mg OTC PP
India
767 P926 PYRANTEL PAMOATE Nemocid Ipca Laboratories Pvt Ltd, Oral Liquid 250 mg/5ml OTC PP
India
768 P127 PYRANTEL PAMOATE Bearantel Beacons Singapore Oral Liquid 125 mg/ 5ml OTC PP
769 P102 PYRANTEL PAMOATE USP Pyrantin Astron Limited, 688, Galle Oral Liquid 50mg/ml (10ml POM PP
Road, Ratmalana, SRILANKA (Suspension) bottle)

770 P1208 PYRIDOXINE Benadon Piramal Enterprises Limited, Tablet 40 mg POM PP

India
771 P1890 PYRIMETHAMINE + Fansidar Roche Tablet 25/500 mg POM PP
SULPHADOXINE
772 P488 PYRIMETHAMINE + Maladar Efroze Pakistan Tablet 25/500 mg POM PP
SULPHADOXINE
773 P456 PYRITINOL Encephabol Merck Ltd, India Oral Liquid 100 mg / 5 ml POM PP
774 P457 PYRITINOL Encephabol Merck Ltd, India Tablet 200 mg POM PP

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 43 of 52 Authorized by:DG,MFDA
 775 P455 PYRITINOL DIHYDROCHLORIDE Encephabol 100 MERCK LIMITED, At: Plot Film coated tablet 100 mg POM PP
MONOHYDRATE No. H-19,M.I.D.C., Waluj,
Aurangabad - 431 133,
INDIA
776 P784 RANITIDINE Zantac GlaxoSmithKline, China Tablet 300 mg POM PP E

777 P739 RANITIDINE Zinetac GlaxoSmithKline, India Tablet 300 mg POM PP E

778 P1631 RANITIDINE Ranitin Torrent, India Tablet 300 mg POM PP E

779 P740 RANITIDINE Zinetac GlaxoSmithKline, India Injection 25 mg/ml POM PP E

780 P675 RANITIDINE Zantac GlaxoSmithKline, Tablet 300 mg POM PP E

Pakistan/Srilanka
781 P785 RANITIDINE HYDROCHLORIDE Zantac GlaxoSmithKline Injection 25mg/ml POM PP E ADK Company PvtLtd
Manufacturing S.p.A. -
Parma, ITALY
782 P1632 RANITIDINE HYDROCHLORIDE IP Ranitin TORRENT Injection 25 mg/ml POM PP E
PHARMACEUTICALS LTD.
Indrad-382 721, Dist.
Mehsana, INDIA, At: Village
: Sachana, Tal,: Viramgam,
Dist.: Ahmedabad 382 150.,
INDIA

783 P1633 RESPERIDONE USP Respidon-2 TORRENT Film coated tablet 2 mg POM PP E
PHARMACEUTICALS LTD. 32
No. Middle Camp, NH-31A,
East District, Gangtok,
Sikkim-737 135, INDIA

784 P1634 RESPERIDONE USP Respidon-1 TORRENT Film coated tablet 1 mg POM PP E
PHARMACEUTICALS LTD. 32
No. Middle Camp, NH-31A,
East District, Gangtok,
Sikkim-737 135, INDIA

785 P202 ROXITHROMYCIN Roxibid Cadila/ Zydus Health Care Tablet 150 mg POM PP
India
786 P927 ROXITHROMYCIN Roxeptin Ipca Laboratories Pvt Ltd, Tablet 50mg POM PP
India
787 P787 SALBUTAMOL Ventolin GlaxoSmithKline, SriLanka Nebulising 5mg/ml in 10ml POM PP E
Solution
788 P677 SALBUTAMOL Ventolin GlaxoSmithKline, Pakistan Tablet 4 mg POM PP E

789 P790 SALBUTAMOL Ventolin GlaxoSmithKline, SriLanka Aerosol 100 mcg/md in 80md POM PP E

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 44 of 52 Authorized by:DG,MFDA
 790 P791 SALBUTAMOL Ventolin GlaxoSmithKline, SriLanka Aerosol 100 mcg/md in POM PP E
200md
791 P792 SALBUTAMOL Ventolin GlaxoSmithKline, SriLanka Injection 5mg / 5ml POM PP E

792 P788 SALBUTAMOL Ventolin GlaxoSmithKline, SriLanka Injection 0.5mg/ml POM PP E

793 P679 SALBUTAMOL Ventolin GlaxoSmithKline, Injection 0.5mg/ml POM PP E

Pakistan/Srilanka
794 P678 SALBUTAMOL Ventolin GlaxoSmithKline, India Nebulising 5mg/ml in 20ml POM PP E
Solution
795 P789 SALBUTAMOL (AS SULPHATE BP) Ventolin Glaxo Wellcome Ceylon Oral Liquid 2 mg/5 ml (100ml) POM PP E
Limited, 121, Galle Road, (Syrup)
Kaldamulla, Moratuwa,
SRILANKA

796 P668 SALBUTAMOL (AS SULPHATE BP) + Ventolin Expectorant GlaxoSmithKline Pakistan Oral Liquid 1mg + 50mg in 5ml POM PP
GUAIPHENESIN BP Limited, F/268, S.I.T.E., (120ml bottle)
Karachi, PAKISTAN

797 P299 SALBUTAMOL SULPHATE IP Asthalin-2 CIPLA LTD., INDIA Uncoated tablet 2 mg POM PP E

798 P680 SALBUTAMOL SULPHATE IP Ventorlin Inhaler GlaxoSmithKline Australia Aerosol 100 mcg/ POM PP E
Pty Ltd., 1061 Mountain 200metered dose
Highway, Boronia 3155, (18g)
AUSTRALIA (Marketed by
GSK INDIA)

799 P301 SALBUTAMOL SULPHATE IP Asthalin Inhaler CIPLA LTD. Kumrek, Rangpo Inhaler 100 mcg/200 POM PP E
Sikkim 737 132, INDIA metered Dose

800 P519 Salicylic acid + Benzoic acid Mycoderm FDC India Powder 3% + 6% in 100gm POM PP
801 P520 SALICYLIC ACID + BENZOIC ACID Mycoderm C FDC India Powder 3%+ 6%+1% in 75gm POM PP E
+CLOTRIMAZOLE
802 P304 SALMETEROL Serobid Cipla India Capsule 50 mcg/md POM PP E
803 P1594 SELEGILINE Eldepryl Themis, India Tablet 5mg POM PP E
804 P1595 SELEGILINE Eldepryl Themis, India Tablet 10mg POM PP E
805 P208 SILDENAFIL Penegra Cadila/ Zydus Health Care Tablet 25mg POM PP E
India
806 P306 SILDENAFIL Silagra Cipla India Tablet 25mg POM PP E
807 P1812 SILDENAFIL Progra Cipla India Tablet 100 mg POM PP E
808 P1528 SIMETHICONE Diptopax Schering AG, Germany Oral Liquid 25mg OTC PP
809 P1335 SIMETHICONE Infacol Sigma Pharmaceuticals, Oral Liquid 40 mg/ ml OTC PP
Australia

810 P66 SIMETHICONE + FUNGAL DIASTASE Aristozyme Aristo India Capsule 50 mg+ 50 mg+ 10 POM PP
+ PEPSIN mg

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 45 of 52 Authorized by:DG,MFDA
 811 P564 SISOMICIN Ensamycin Fulford India Cream 1 mg/ml POM PP
812 P565 SISOMICIN Ensamycin Fulford India Eye Drops 1 mg/ml POM PP
813 P2824 SODIUM ACETATE IP + POTASSIUM Iveolyte-P Fresenius Kabi India Pvt. Iv Infusion 0.32g + 0.13g + POM PP E Each Shipment should be
CHLORIDE IP + DIBASIC Limited. A-3, MIDC, 0.026g + 0.031g + accompanied by the batch
POTASSIUM PHOSPHATE USP + Ranjangaon Ganpati, Tal. 5.0g ( 500 ml) certificates
MAGNESIUM CHLORIDE + Shirur, Dist. Pune 412 220,
DEXTROSE ANHYDROUS IP INDIA.

814 P1415 SODIUM ALGINATE IP + SODIUM Gaviscon Reckitt Benckiser Oral Liquid 250 mg + 133.5 mg + OTC PP E
BICARBONATE IP + CALCIUM Healthcare India Ltd. P.O. 80 mg (150ml)
CARBONATE IP Baddi District , Solan -
173205 (H.P.) INDIA

815 P1416 SODIUM ALGINATE Gaviscon Reckkit Benchiser Tablet 250 mg(Ph.Eur) OTC PP E
PH.EUR+SODIUM BICARBONATE Healthcare UK Limited +133.5 mg(Ph.Eur)+
PH.EUR+CALCIUM 80 mg(Ph.Eur)
CARBONATEPH.EUR

816 P9 SODIUM BICARBONATE Citro-soda granules Abbott Pakistan Powder 1716 mg+ OTC PP E
+TARTARIC ACID+CITRIC ACID+ 858mg+702 mg +613
SODIUM CITRATE mg
817 P1576 SODIUM BICARBONATE BP + Eno salt GlaxoSmithKline Pakistan Powder for Oral 2.32g + 2.18g per 5g OTC PP E
CITRIC ACID BP Limited, 35-Dockyard Road, Solution (Sachets)
West Wharf, Karachi ,
PAKISTAN

818 P1712 SODIUM BICARBONATE IP Sodium Bicarbonate Vulcan Laboratories Pvt. Injection 7.5% w/v POM PP E
Ltd., P-36, Kasba Industrial
Estate, Phase-III, Kolkata -
700 107, INDIA

819 P1713 SODIUM CHLORIDE Sodium Chloride Vulcan, India Injection 0.90% POM PP E Each Shipment should be
accompanied by the batch
certificates
820 P128 SODIUM CHLORIDE Normal Saline Beacons Singapore Eye Drops 0.90% POM PP E
821 P537 SODIUM CHLORIDE + POTASSIUM Electral forte FDC India Powder for Oral 2.6 g+1.5 g + OTC PP
CHLORIDE + SODIUM CITRATE + Solution 2.9g(IP)+13.5 g per
DEXTROSE sachet
822 P1165 SODIUM CHLORIDE + POTASSIUM Electrobion Merck Marker, Pakistan Powder for Oral 2.6 g+1.5 g + OTC PP E
CHLORIDE + SODIUM CITRATE + Solution 2.9g(IP)+13.5 g per
DEXTROSE sachet
823 P538 SODIUM CHLORIDE + POTASSIUM Coslyte FDC India Powder for Oral 2.6 g+1.5 g + OTC PP E
CHLORIDE + SODIUM CITRATE + Solution 2.9g(IP)+13.5 g per
DEXTROSE sachet
824 P543 SODIUM CROMOGLYCATE Allercrom FDC India Eye Drops 2% w/v POM PP E
825 P308 SODIUM CROMOGLYCATE Cromal-5 Inhaler Cipla India Inhaler 5mg/MD POM PP E

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 46 of 52 Authorized by:DG,MFDA
 826 P1427 SODIUM CROMOGLYCATE Fintal Rhone Poulenc Nasal Spray 2% in 20ml POM PP E
827 P1055 SODIUM FUSIDATE Fucidine Tulle Leo, Pakistan Medicated OTC PP E
Dressing
828 P1048 SODIUM FUSIDATE Fucithalmic Leo Pharmaceutical, Eye Ointment 1% in 5gm POM PP E
Germany
829 P1740 SODIUM LACTATE Sodium Lactate Wockhardt, India Injection 500ml IP POM PP E Each Shipment should be
accompanied by the batch
certificates
830 P833 SODIUM NITROPRUSIDE Sonide Mepromax Life Sciences Injection 50mg/5ml POM PP E

831 P981 SODIUM VALPORATE Epilex Akums Drugs & Oral Liquid 200 mg/5ml 100ml POM PP E
Pharmaceuticals Ltd., India

832 P980 SODIUM VALPORATE Epilex Akum Drugs and Tablet 200 mg IP POM PP E
Pharmaceuticals Ltd, India

833 P1511 SPIRONOLACTONE IP Aldactone 100 RPG Life Sciences Limited, Uncoated Tablet 100 mg POM PP E
3102/A, G.I.D.C. Estate,
Ankleshwar - 393 002.,
INDIA

834 P1512 SPIRONOLACTONE IP Aldactone RPG Life Sciences Limited, Uncoated tablet 25 mg POM PP E
3102/A, G.I.D.C. Estate,
Ankleshwar - 393 002.,
INDIA

835 P1209 SULPHACETAMIDE Albucid Abbott/Allergan Topical Solution 10% POM PP E

836 P1210 SULPHACETAMIDE Albucid Abbott/Allergan Topical Solution 20% POM PP E

837 P630 SUXAMETHONIUM CHLORIDE Suxomin Neon Laboratories, India Injection 50mg/ml POM PP E

838 P3 TERAZOSIN Hytrin Abbott Pakistan Tablet 5 mg POM PP E

839 P1888 TERBINAFINE Sebifin cream Sun pharmaceuticals, India Cream 1% 10g POM PP

840 P1275 TERBINAFINE Lamisil Novartis, Pakistan Cream 1% POM PP

841 P1273 TERBINAFINE Lamisil Novartis, Pakistan Tablet 125mg POM PP
842 P1274 TERBINAFINE Lamisil Novartis, Pakistan Tablet 250mg POM PP
843 P842 TETRACYCLINE Tetracycline Hindustan Antibiotics, India Capsule 250 mg POM PP E

844 P901 TETRACYCLINE Hostacycllin Aventis Pharma Ltd Capsule 250 mg POM PP E
845 P1108 TETRACYCLINE Tetracycline Lyka BDR India Capsule 250 mg POM PP E
846 P203 TETRACYCLINE Tetracycline Cadila/ Zydus Health Care Capsule 250 mg POM PP E
India
847 P1683 TETRACYCLINE Tetracap USV, India Capsule 250 mg POM PP

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 47 of 52 Authorized by:DG,MFDA
 848 P10 TETRAHYDROZOLINE Murine Clear Eyes Abbott Pakistan Topical Solution 0.05% POM PP

849 P11 TETRAHYDROZOLINE Murine Plus Abbott Pakistan Topical Solution 0.05% POM PP

850 P681 THEOPHYLLINE Amphyl GlaxoSmithKline, Injection 25 mg /1 ml POM PP

Pakistan/Srilanka
851 P4201 THIAMINE MONONITRATE , Neurobion Forte Merck Limited, India Tablet 10 mg +10 mg +3mg OTC PP
RIBOFLAVIN , PYRIDOXINE HCL , + 15 mcg 45 mg + 50
CYNAECOBALAMIN TRINITRATE , mg
NICOTINAMIDE , CALCIUM
PANTOTHENATE
852 P1276 THIORIDAZINE Melleril Novartis, Pakistan Tablet 10 mg POM PP
853 P1277 THIORIDAZINE Melleril Novartis, Pakistan Tablet 25 mg POM PP
854 P743 THYROXINE SODIUM IP Eltroxin GlaxoSmithKline Uncoated Tablet 100 mcg POM PP E
Pharmaceuticals Limited,
At: A-10, M.I.D.C., Ambad-
Pathardi Block, Nashik 422
010., INDIA

855 P545 TIMOLOL Iotim FDC India Eye Drops 0.50% POM PP
856 P1185 TIMOLOL Timoptol MSD, Pakistan Eye Drops 0.25% POM PP
857 P1186 TIMOLOL Timoptol MSD, Pakistan Eye Drops 0.50% POM PP
858 P544 TIMOLOL Iotim FDC India Eye Drops 0.25% POM PP
859 P1340 TINIDAZOLE Fasigyn Pfizer, India Tablet 500 mg POM PP
860 P1355 TINIDAZOLE Fasigyn Pfizer, Pakistan Tablet 300 mg POM PP
861 P204 TINIDAZOLE Tiniba Cadila/ Zydus Health Care Tablet 500mg POM PP
India
862 P309 TINIDAZOLE Tinidazole Cipla India Tablet 300mg POM PP
863 P310 TINIDAZOLE Tinidazole Cipla India Tablet 500mg POM PP
864 P1341 TINIDAZOLE IP Fasigyn DS Pfizer Limited, At: Plot No. J- Film coated tablet 1000 mg POM PP
76, MIDC, Tarapur, Taluka
Palghar, Dist. Thane 401
506, INDIA
865 P1356 TINIDAZOLE USP Fasigyn Pfizer Limited, At: B-2, Film coated tablet 500 mg POM PP
S.I.T.E., Karachi, PAKISTAN

866 P104 TIOCONAZOLE Trosyd Astron Limited, Sri Lanka Cream 1% in 5gm POM PP

867 P105 TIOCONAZOLE Trosyd Astron Limited, Sri Lanka Cream 1% in 15gm POM PP

868 P103 TIOCONAZOLE Gyno Trosyd Astron Limited, Sri Lanka Tablet (Vaginal) 100 mg POM PP

869 P566 TOLNAFTATE Tinaderm Fulford India Cream 2 mg/ml POM PP E

870 P567 TOLNAFTATE Tinaderm Fulford India Topical Solution 2 mg/ml POM PP E

871 P568 TOLNAFTATE + MICONAZOLE Tinaderm M Fulford India Cream POM PP

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 48 of 52 Authorized by:DG,MFDA
 872 P953 TOPIRAMATE Topamax CILAG LTD, Schaffausen, Tablet 50 mg POM PP
Switzerland
© Jassen Cilag

873 P952 TOPIRAMATE Topamax CILAG LTD, Schaffausen, Tablet 25 mg POM PP

Switzerland
© Jassen Cilag

874 P2463 TRAMADOL Tramazac Zydus Cadila Capsule 50 mg CONTROLLED PP

875 P2462 TRAMADOL Tramazac Zydus Cadila Injection 50 mg/ml CONTROLLED PP
876 P2464 TRAMADOL Tramazac Zydus Cadila Tablet 50 mg CONTROLLED PP
877 P1749 TRIAMCINOLONE Ledercort Wyeth, India Injection 0.10% POM PP
878 P1780 TRIAMCINOLONE Ledercort Wyeth Lederle, Pakistan Injection 0.10% POM PP

879 P1782 TRIAMCINOLONE Ledercort Wyeth Lederle, Pakistan Tablet 4 mg POM PP

880 P1781 TRIAMCINOLONE Ledercort Wyeth Lederle, Pakistan Topical Ointment 0.1% 5g POM PP

881 P734 TRIAMCINOLONE +NEOMYCIN + Pragmatar GlaxoSmithKline, India Topical Ointment 1% + 2.5mg + 100000 POM PP E
NYSTATIN +GRAMICIDIN units + 0.25mg/gm

882 P4189 TRIBASIC CALCIUM PHOSPHATE , Ostocalcium GSK, India Tablet 380mg + D3 400iu OTC PP
VITAMIN D3
883 P4188 TRIBASIC Ostocalcium GSK, SriLanka Oral Liquid 82mg + 200iu+ OTC PP
CALCIUM,PHOSPHATE,VITAMIN 2.5mcg /5ml
D3, B12
884 P1282 TRIBENOSIDE+ LIDOCAINE Proctoglyvenol Novartis, Switzerland Cream 5% + 2% in 100 g POM PP E
HYDROCHLORIDE
885 P1283 TRIBENOSIDE+ LIDOCAINE Proctoglyvenol Novartis, Switzerland Suppository 400 mg + 40 mg in POM PP E
HYDROCHLORIDE 2g
886 P1570 TRIFLUOPERAZINE Stelazin SKB, Pakistan Tablet 1mg POM PP E
887 P1571 TRIFLUOPERAZINE Stelazin SKB, Pakistan Tablet 5mg POM PP E
888 P1234 TRIFLURIDINE Triherpine Novartis Cibavision, Eye Drops 10mg/ml x5ml POM PP E
Pakistan
889 P1235 TRIFLURIDINE Triherpine Novartis Cibavision, Eye Ointment 10mg/g x2.5g POM PP E
Pakistan
890 P1783 TRIHEXYPHENIDYL Pacitane Pfizer Limited, At: Plot No. Uncoated Tablet 2 mg POM PP E
HYDROCHLORIDE IP 47B/2,Phase I, Street No. 4,
I.D.A. Cherlapally,
Hyderabad 500 051, INDIA
(Registered Proprietor -
Wyeth Holdings, USA)

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 49 of 52 Authorized by:DG,MFDA
 891 P1539 TRIMETAZIDINE Flavedon Servier Research & Tablet 20 mg POM PP
Pharmaceuticals, Pakistan

892 P1540 TRIMETAZIDINE Vastarel Servier Research & Tablet 20 mg POM PP

Pharmaceuticals, Pakistan

893 P311 TRIMETAZIDINE Trivedone Cipla India Tablet 20 mg POM PP

894 P489 TRIMETAZIDINE Dinemic Efroze Pakistan Tablet 20 mg POM PP
895 P695 TRIPROLIDINE HCL + Actifed GlaxoSmithKline, SriLanka Oral Liquid 1.25mg+30mg CONTROLLED PP E
PSEUDOEPHEDRINE
896 P754 TRIPROLIDINE HCL Actifed Expectorant GlaxoSmithKline, SriLanka Oral Liquid 1.25mg+30mg+100m CONTROLLED PP E
+PSEUDOEPHEDRINE + g
GUAIPHENESIN
897 P533 UREA IP + LACTIC ACID IP + Cotaryl FDC Limited, At: 75/1 Cream 12% w/w + 6% w/w + OTC PP E
GLYCINE IP + AMMONIUM G.I.D.C., Vapi 396 195 3% w/w + 0.5% w/w
CHLORIDE IP + SODIUM CHLORIDE Gujarat, INDIA + 0.5% w/w + 0.5%
IP + POTASSIUM CHLORIDE IP + w/w + 0.5% w/w +
CALCIUM LACTATE IP + 0.3% w/w + 0.5 %
MAGNESIUM CHLORIDE IP + w/w
SODIUM DIHYDROGEN +
PHOSPHATE DIHYDRATE IP

898 P745 VACCINE HEPATITIS B (Pedeatric) Engerix B GlaxoSmithKline, Belgium Injection 20 mcg/ml POM PP E

899 P793 VARICELLA ZOSTER VIRUS (OKA Varilrix GlaxoSmithKline Biologicals Injection 10^3.3 PFU (0.5ml POM PP ADK Company PvtLtd
STRAIN) S.A. Rue de I'Institut, 89, B- single dose)
1330 Rixensart, BELGIUM

900 P602 VERAPAMIL Isoptin Cadila Health Care Tablet 40mg POM PP
Ltd/German Remedies
901 P1211 VERAPAMIL HYDROCHLORIDE IP Calaptin 40 Abbott Healthcare Pvt. Ltd. Film coated tablet 40 mg POM PP
At: Plot No -225/3, G.I.D.C.,
Vapi - 396 195, Dist. Valsad,
Gujarat, INDIA

902 P1212 VITAMIN A Arovit Abbott Tablet 150000 iu POM PP E

903 P1166 Vitamin A ,Vitamin E , C 500mg, Multibionta Merck Marker, Pakistan Injection Vitamin A 10000 OTC PP E
Vitamin B1,Vitamin B2, Vitamin units, Vitamin E 5mg,
B6 , Nicotinamide , Pentothenyl C 500mg, B1 50mg B2
alcohol 10mg B6 15mg
Nicotinamide 100mg,
Pentothenyl alcohol
25mg

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 50 of 52 Authorized by:DG,MFDA
 904 P4225 Vitamin A + Vitamin D + Omega Codliver Oil Cipla Ltd., India Soft Gelatine 300mg OTC -
3 Capsule
905 P4226 Vitamin A + Vitamin D + Omega Codliver Oil Sun Pharmaceuticals Ltd. Soft Gelatine 300mg OTC -
3 India Capsule
906 P4224 Vitamin A + Vitamin D + Omega SeaCod (Cod Liver Oil) Universal Medicare Pvt. Soft Gelatine 300mg OTC -
3 (BP) Ltd., India Capsule
907 P4227 Vitamin A + Vitamin D + Omega Cod Liver Oil SevenSeaS MERCK LIMITED, India Soft Gelatine 300mg OTC -
3 (BP) Capsule
908 P4228 Vitamin A + Vitamin D + Omega- SeaCod (Cod Liver Oil) UPHA Pharmaceutical Emulsion Each 15ml contains OTC -
3 fatty acids) Mfg, (M) Sdn Bhd, codliver oil 450mg,
Malaysia Vitamin A 850iu,
Vitamin D 85iu
Calcium
Hypophosphite 424
e.q. calcium 100 mg

909 P4229 Vitamin A + Vitamin D + Omega- Codliver Oil CCM Upharmacuticals Emulsion Each 15ml contains OTC -
3 fatty acids) MFG (M) Sdn Bhd, codliver oil 450mg,
Malaysia Vitamin A 850iu,
Vitamin D 85iu
Calcium
Hypophosphite 424
e.q. calcium 100 mg

910 P460 VITAMIN B (B1 + B2 + B6 + B12 + Polybion Merck Ltd, India Injection 5mg+ 2mg+ 2mg+ OTC PP E
NICOTINAMIDE + PENTOTHENYL 4mcg+ 20mg+
ALCOHOL) 3mg/ml
911 P683 VITAMIN B 12 Cytacon GlaxoSmithKline, SriLanka Oral Liquid 35 mcg/ 5 ml OTC PP E

912 P684 VITAMIN B 12 Cytamen GlaxoSmithKline, Pakistan Injection 1000mcg/ml OTC PP E

913 P1475 VITAMIN B1 Benerva Roche, Pakistan Tablet 100 mg OTC PP E

914 P4199 Vitamin B1 2,Viitamin B2 ,Vitamin Polybion Merck Ltd, India Oral Liquid 2mg+ 2.5mg + OTC PP
B6, Vitamin B12 , Nicotinamide , 0.75mg+ 2mcg
Pentothenyl alcohol +15mg+ 3mg/5ml in
100ml
915 P1853 VITAMIN C Cecon Abbott Oral Drops 100 mg/ml OTC PP E
916 P6 VITAMIN C Cecon Abbott Pakistan Tablet 100 mg OTC PP E
917 P1492 VITAMIN C Redoxon Roche, Switzerland Tablet 1 gm OTC PP E
918 P4187 VITAMIN C Celin GSK, India Tablet 100 mg OTC PP
919 P4194 VITAMIN C Sunkist Gum Drops Novartis various Tablet Chewable 60mg OTC PP
manufacturers

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 51 of 52 Authorized by:DG,MFDA
 920 P7 VITAMIN C USP/EUR.P. Cecon Abbott Laboratories Oral Drops 100mg / ml (10ml OTC PP E
(Pakistan) Ltd. Landhi, bottle)
Karachi, PAKISTAN
921 P4183 VITAMIN D3 + CALCIUM Cipcal Cipla, India Tablet 250 mg OTC PP
922 P458 VITAMIN E Evion Merck Ltd, India Oral Drops 50mg/ml OTC PP E
923 P1928 VITAMIN E E Vita-400 Vita Health Laboratories, Capsule 400 IU OTC PP E
Australia.

924 P4182 VITAMIN E Vitamin E Cadila/ Zydus Health Care, Capsule 400 mg OTC PP
India
925 P4184 VITAMIN E Evitam Cipla, India Capsule 400mg OTC PP
926 P4185 VITAMIN E Evion 100 Merck Ltd, India Capsule 100 mg OTC PP
927 P4190 VITAMIN E Evion Merck Marker, Pakistan Capsule 100 mg OTC PP
928 P4191 VITAMIN E Evion Merck Marker, Pakistan Capsule 200 mg OTC PP
929 P4192 VITAMIN E Evion Merck Marker, Pakistan Capsule 400 mg OTC PP
930 P4193 VITAMIN E Evion Merck Marker, Pakistan Capsule 600 mg OTC PP
931 P312 VITAMIN E + ALOE Sofderm Cipla India Cream 0.5% + 10% OTC PP
932 P1493 VITAMIN K (Phytomenadione) Konakion Roche, Switzerland Injection 2mg/0.2ml POM PP E

933 P1715 VITAMIN K 1 (Phytomenadione) Menadione Vulcan, India Injection 10 mg POM PP E

934 P4198 VITAMINS Surbex T Abbott, Pakistan Tablet 15mg+10mg+5mg+4 OTC PP

mcg+500mg+20mg+1
00mg
935 P685 VITAMN A + VITAMIN D+ VITAMIN Becadex GlaxoSmithKline, SriLanka Oral Drops 3000 IU + 500 IU + OTC PP E
B1 + VITAMIN B2 + VITAMIN B12 + 1.5mg +1.2mg+
NICOTINOMIDE 20mcg + 10mg in
200ml
936 P317 WARFARIN SODIUM CLATHRATE IP Warf - 1 CIPLA LTD. Maipur, Dist. Uncoated tablet 1 mg POM PP E
Solan 173 205, INDIA
937 P318 WARFARIN SODIUM CLATHRATE IP Warf - 2 CIPLA LTD. Maipur, Dist. Uncoated tablet 2 mg POM PP E
Solan 173 205, INDIA
938 P603 XANTHINOL NICOTINATE Complamina Zydus Health Care,India Tablet 150 mg POM PP

939 P604 XANTHINOL NICOTINATE Complamina retard Zydus Health Care,India Tablet 500 mg POM PP

940 P605 XANTINOL NICOTINATE Complamina Zydus Health Care,India Injection 300mg/2ml in 2ml POM PP

1.For the Products in this list where the formulation is mentioned, that specific formulation only can be imported
2.For those products in which the fomulation is not mentioned, the product imported should be of export quality and not specified for a specific market

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 52 of 52 Authorized by:DG,MFDA
 List 3: Exemption Approval List (EA)
These are special approvals for importing pharmaceutical products based on minimum evaluation of safety and quality of the product with information of the
imports and availability in the market of the same. This approval is a temporary approval granted for a period of 1 year. For further import after 1 year, it has to
be registered by full dossier submission under the registration criteria. Once registered by submitting full dossier then it will be added to the registered product
list.
Serial No

Product Generic name Product name Manufacturer / Dosage form strength Catergory Status Essen Reg Date Remarks
No Company name tiality

1 P1413 ACETYL SALICYLIC ACID Cardiprin Reckkit & Colman Tablet 100 mg POM EA E 08.10.2017 -
31.07.2019

2 P122 ACETYLCYSTEINE USP Mucomix Samarth Life Sciences Injection 200 mg Restricted for EA E 08.10.2017 -
Pvt. Ltd, India (400mg/2ml Hospital use only 31.07.2019

3 P1706 ADRENALINE Adrenaline Vulcan Labaratories, Injection 0.36 mg/ml Restricted for EA E 08.10.2017 -
India Hospital/Instituti 31.07.2019
onal use only

4 P2926 Adrenaline Bitartrate Injection Vasocon Neon Laboratories Injection 1mg /ml Restricted for EA E 08.10.2017 -
IP Limited, India Hospital/Instituti 31.07.2019
onal use only

5 P1118 ALPROSTADIL Alpostin Samarth Life Sciences Injection 0.5mg/ml Restricted for EA 08.10.2017 -
Pvt. Ltd, India (500mcg/ml) Hospital use only 31.07.2019

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 1 of 17 Authorized by:DG,MFDA
6 P508 AMIKACIN ALFAKIM Nitin Life Sciences Ltd., Injection 250mg/ml (in POM EA E 08.10.2017 -
India 2ml) 31.07.2019

7 P507 AMIKACIN ALFAKIM Nitin Life Sciences Ltd. / Injection 125mg/ml (in POM EA E 08.10.2017 -
INDIA 2ml) 31.07.2019

8 P1599 AMIODARONE IP Cordarone SANOFI - SYNTHELABO Tablet 100 mg POM EA E 08.10.2017 -

(INDIA) LTD., INDIA 31.07.2019

9 P2557 ATOMOXETINE Axepta Intas Pharmaceutical Tablet 10 mg POM EA E 08.10.2017 -

HYDROCHLORIDE IP Ltd., India 31.07.2019

10 P612 ATRACURIUM BESILATE Artacil Neon Laboratories Injection 10mg/ml Restricted for EA E 08.10.2017 -
Limited, India Hospital use only 31.07.2019

11 P2922 ATROPINE SULPHATE Tropine Neon Laboratories Injection 0.65 mg/ml Restricted for EA E 08.10.2017 -
Limited, India Hospital/Instituti 31.07.2019
onal use only

12 P1707 ATROPINE SULPHATE Atropine Vulcan Labaratories, Injection 0.65 mg/ml Restricted for EA E 08.10.2017 -
India Hospital/Instituti 31.07.2019
onal use only

13 P211 BENZOYL PEROXIDE Pernex Ac Adcock Ingram Gel 2.5% w/w OTC EA 08.10.2017 -
Healthcare Pvt Ltd., 31.07.2019
India

14 P156 BISACODYL Dulcoflex Recipharm Tablet 5 mg POM EA E 08.10.2017 -

Pharmaservices Private 31.07.2019
Limited, Bangalore,
India

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 2 of 17 Authorized by:DG,MFDA
15 P576 BISACODYL Dulcoflex Bliss GVS Pharma Suppository 10 mg POM EA E 08.10.2017 -
Ltd,India 31.07.2019

16 P578 BISACODYL Dulcoflex Bliss GVS Pharma Suppository 5 mg POM EA E 08.10.2017 -

Ltd,India 31.07.2019

17 P3360 BISOPROLOL FUMARATE Concor 5 Merck Limited, India Tablet 5mg POM EA 08.10.2017 -
31.07.2019

18 P3228 BUDESONIDE + FORMOTEROL Foracort Cipla Limited, India Inhaler 100/6mcg POM EA E 08.10.2017 -
FUMARATE 31.07.2019

19 P3229 BUDESONIDE + FORMOTEROL Foracort Cipla Limited, India Inhaler 400/6mcg POM EA E 08.10.2017 -
FUMARATE 31.07.2019

20 P76 BUPIVACAINE ANAWIN Neon Laboratories Injection 0.25% Restricted for EA E 08.10.2017 -
HYDROCHLORIDE Limited, India Hospital use only 31.07.2019

21 P77 BUPIVACAINE ANAWIN Neon Laboratories Injection 0.50% Restricted for EA E 08.10.2017 -
HYDROCHLORIDE Limited, India Hospital use only 31.07.2019

22 P1260 CALCIUM GLUCONATE Calcium Gluconate Vulcan Laboratories, Injection 10% Restricted for EA E 08.10.2017 -
Indida Hospital use only 31.07.2019

23 P78 CARBOPROST Endoprost Bharat Serums & Injection 250 mcg / ml Restricted for EA E 08.10.2017 -
TROMETHAMINE IP Vaccines Ltd, India Hospital use only 31.07.2019

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 3 of 17 Authorized by:DG,MFDA
24 P1417 CETALKONIUM CHLORIDE + Bonjela Macter International Ltd Gel 8.7% + 0.01% OTC EA 08.10.2017 -
CHOLINE SALICYLATE ,Pakistan 31.07.2019

25 P490 CHYMOTRYPSIN +TRYPSIN Chymoral Forte WINDLAS BIOTECH Tablet 1,00, 000 units POM EA 08.10.2017 -
LIMITED, INDIA 31.07.2019

26 P1661 CLINDAMYCIN Dalacin C Pfizer Pakistan Ltd., Capsule 150 mg POM EA 08.10.2017 -
Pakistan 31.07.2019

27 P1662 CLINDAMYCIN Dalacin C Pfizer Pakistan Ltd., Capsule 300mg POM EA 08.10.2017 -
Pakistan 31.07.2019

28 P572 CLINDAMYCIN Clindac A Encube Ethicals Pvt. Ltd, Gel 1% w/w POM EA 08.10.2017 -
HYDROCHLORIDE India 31.07.2019

29 P722 CLOBETASOL Tenovate ENCUBE ETHICALS Ointment 0.05% w/w POM EA E 08.10.2017 -
PVT.LTD /INDIA 31.07.2019

30 P555 CLOBETASOL PROPIONATE IP + Dipsalic F TORRENT Ointment 0.05% w/w + 3% POM PP 08.10.2017 -
SALICYLIC ACID IP PHARMACEUTICALS w/w 31.07.2019
LTD., INDIA

31 P1766 CONJUGATED ESTROGEN Premarin Pfizer/Canada Cream (Vaginal) 0.625mg POM EA E 08.10.2017 -
31.07.2019

32 P1589 CYPROHEPTADINE Peritol Ravian Life Science Pvt Oral Liquid 2 mg/5 ml POM EA 08.10.2017 -
Ltd, India 31.07.2019

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 4 of 17 Authorized by:DG,MFDA
33 P1518 CYPROTERONE ACETATE + Diane 35 Bayer Weimar GMBH Tablet 2mg+35mcg POM EA 08.10.2017 -
ETHINYLESTRADIOL UND Co.Kg, Germany 31.07.2019

34 P3174 DESLORATADINE Aerius Merck Limited, Pakistan Oral Liquid 0.5mg/ml OTC EA 08.10.2017 -
31.07.2019

35 P3838 DICLOFENAC DIETHYLAMINE Volini SUN PHARMACEUTICAL SPRAY 1.16% W/V + 1% POM TA 08.10.2017 -
BP + LINSEED OIL BP + METHYL INDIA LTD., INDIA W/W + 3% W/V 31.07.2019
SALICYLATE IP + MENTHOL IP + 10% W/V +
5%W/V
36 P2928 DIGOXIN Dixin Samrath India (Samrath Injection 0.25 mg/ml Restricted for EA E 08.10.2017 -
Biologicals) Hospital use only 31.07.2019

37 P1314 DIMETHICONE IP + GELUSIL MPS PFIZER LIMITED /INDIA Oral Liquid 50MG+ 250MG+ OTC EA E 08.10.2017 -
MAGNESIUM HYDROXIDE IP + 250MG+ 70% 31.07.2019
DRIED ALUMINIUM
HYDROXIDE IP + SORBITOL

38 P2838 DINOPROSTONE Cerviprime AstraZeneca Pharma Gel 0.5 mg Restricted for EA E 08.10.2017 -
India Limited Hospital use only 31.07.2019

39 P1891 DOXYLAMINE SUCCINATE + Doxinate MANEESH Tablet 10 mg+ 10 mg POM EA 08.10.2017 -

PYRIDOXINE PHARMACEUTICALS 31.07.2019
LTD., INDIA

40 P1315 DRIED ALUMINIUM Gelusil MPS Pfizer Limited, India Uncoated 250mg + 250mg OTC EA E 08.10.2017 -
HYDROXIDE IP + MAGNESIUM Chewable tablet + 50mg + 50mg 31.07.2019
HYDROXIDE IP + MAGNESIUM
ALUMINIUM SILICATE
HYDRATE + ACTIVATED
DIMETHICONE IP

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 5 of 17 Authorized by:DG,MFDA
41 P2451 Enoxaparin Sodium Clexane Sanofi Winthrop Injection 20mg/0.2ml POM EA 08.10.2017 -
Industries , France 31.07.2019

42 P2452 Enoxaparin Sodium Clexane Sanofi Winthrop Injection 40mg/0.4ml POM EA 08.10.2017 -
Industries , France 31.07.2019

43 P1189 ESMOLOL HCL Esocard Samarth Life Sciences Injection 100mg/10ml Restricted for EA E 08.10.2017 -
Pvt. Ltd, India (10mg/ml) Hospital use only 31.07.2019

44 P985 EVENING PRIMROSE OIL Primosa Universal Medicare Pvt. Soft Gelatin 500 mg OTC EA 08.10.2017 -
Ltd, / India Capsule 31.07.2019

45 P491 FLAVOXATE HYDROCHLORIDE Flavospas Torrent Tablet 200 mg POM EA 08.10.2017 -

Pharmaceuticals Ltd. 31.07.2019
Gangtok, India

46 P195 GENTAMICIN IP Genticyn Nitin LifeSciences Ltd, Injection 40mg/ml (in 2ml) POM EA E 08.10.2017 -
India 31.07.2019

47 P2529 GLYCERYL TRINITRATE Nitroplus Neon Laboratories Injection 25 mg/5 ml POM EA 08.10.2017 -
(NITROGLYCERIN) Limited, India 31.07.2019

48 P954 HAEMOCOAGULASE Botropase Juggat Pharma, India Injection 1cu/ml Restricted for EA 08.10.2017 -
Hospital/Instituti 31.07.2019
onal use only

49 P3127 HAEMOCOAGULASE Reptilase Troikaa Pharmaceuticals Injection 1cu/ml Restricted for EA 08.10.2017 -
Hospital/Instituti 31.07.2019
onal use only

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 6 of 17 Authorized by:DG,MFDA
50 P2841 HAEMOCOAGULASE Haemaccel Aventis Pharma Ltd Injection 1cu/ml, 3.5 Restricted for EA 08.10.2017 -
(Polygeline) gm/100 ml Hospital/Instituti 31.07.2019
onal use only

51 P903 HALOTHANE Hypnothane Neon Laboratories Solution 100% in 250ml Restricted for EA E 08.10.2017 -
Limited, India Hospital use only 31.07.2019

52 P2910 Hepatitis B Immune Globulin Samahep Samrath India (Samrath Injection 10 mcg/0.5 ml Restricted for EA E 08.10.2017 -
(HBIG) Biologicals) Hospital use only 31.07.2019

53 P1545 HUMAN IMMUNOGLOBULIN IMMUNOGLOBULIN Reliance, India Injection 0.5g/10 ml, Restricted for EA 08.10.2017 -
1g/20 ml, Hospital use only 31.07.2019
5g/100 ml

54 P2842 HUMAN NORMAL Immunorel Reliance Life Sciences Injection 5g Restricted for EA 08.10.2017 -
IMMUNOGLOBULIN Pvt. Ltd., India Hospital use only 31.07.2019

55 P2843 HUMAN NORMAL Immunorel Reliance Life Sciences Injection 50g/l + ≥95% + Restricted for EA 08.10.2017 -
IMMUNOGLOBULIN (PROTEIN Pvt. Ltd., India 100g/l + ≤80mg/l Hospital use only 31.07.2019
CONTENT + (1g(5%) in 20ml
IMMUNOGLOBULIN G +
STABILISER MALTOSE + IGA
CONTENT
56 P2455 Hyaluronidase Hynidase Shreya Life Sciences Pvt. Injection 1500IU (in 2ml) Restricted for EA 08.10.2017 -
Ltd., India Hospital use only 31.07.2019

57 P731 HYDROCORTISONE SODIUM Unicort Neon Laboratories Injection 100 mg/ml POM EA E 08.10.2017 -
SUCCINATE Limited, India 31.07.2019

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 7 of 17 Authorized by:DG,MFDA
58 P3400 HYDROQUINONE + Triglow Glenmark Cream 2.0% w/w + POM EA 08.10.2017 -
TRETINOIN+ FLUOCINOLONE Pharmaceuticals Ltd., 0.05% w/w + 31.07.2019
ACETONIDE INDIA 0.01% w/w

59 P212 HYDROUS BENZOYL PEROXIDE Pernex AC 5% Adcock Ingram Gel 5% w/w OTC EA 08.10.2017 -
BP Healthcare Pvt Ltd., 31.07.2019
India

60 P3766 HYOSCINE BUTYLBROMIDE Buscogast Recipharm Tablet 10mg POM EA E 08.10.2017 -

Pharmaservices Private 31.07.2019
Limited, Bangalore,
India

61 P2918 IMDAZOQUINOLIN AMINE/ Imiquad Glenmark Cream 0.25g single use POM EA 08.10.2017 -
IMIQUIMOD Pharmaceuticals Ltd., sachet contains 31.07.2019
India 12.5mg (5%
w/w)

62 P2596 IPRATROPIUM BROMIDE Ipravent Cipla Limited, India Respiratory 250mcg POM EA E 08.10.2017 -
Solution 31.07.2019

63 P1643 ISOPRENALINE Isolin Samarth Pharma Injection 2 mg/ml Restricted for EA E 08.10.2017 -
Pvt.Ltd., India Hospital use only 31.07.2019

64 P2332 ISOTRETINOIN I Deriva Indchemie Health Capsule 20 mg POM EA 08.10.2017 -

Specialities Private 31.07.2019
Limited ,India

65 P439 ISOXSUPRINE Duvadilan ABBOTT INDIA Tablet 10 mg POM EA 08.10.2017 -

HYDROCHLORIDE IP LIMITED., INDIA 31.07.2019

66 P315 LACTOBACILLUS + PYRIDOXINE Nutrolin B Plus Pegasus Farmaco India Capsule 1mg + 25 mg + OTC EA 08.10.2017 -
HCL + NICORTINAMIDE + Pvt ltd/India 7.5 mg + 750 31.07.2019
CYANOCOBALAMIN + FOLIC mcg
ACID

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 8 of 17 Authorized by:DG,MFDA
67 P316 LACTOBACILLUS + PYRIDOXINE Nutrolin B Symbiosis Co-operative Oral Liquid 42 x 10^6 Spores OTC EA 08.10.2017 -
HYDROCHLORIDE + Pharmaceuticals, India + 1.5mg + 20mg 31.07.2019
NICOTINAMIDE

68 P2640 LACTOBACILLUS ACIDOPHILUS Becelac Dr. Reddy's Capsule 2000 L+ 5 mg+26 OTC EA 08.10.2017 -
+ CALCIUM PANTOTHENATE + Laboratories, India mg+ 1 mcg+50 31.07.2019
NIACINAMIDE + VITAMIN B12+ mg+300 mcg+
VITAMIN C + FOLIC ACID + 1.5 mg+ 3 mg+2
VITAMIN B6 + VITAMIN B2 mg
+THIAMINE MONONITRATE

69 P2078 LEVETIRACETAM Levipil 250 Sun Pharma Tablet 250mg POM EA 08.10.2017 -
Laboratories Ltd, India 31.07.2019

70 P2079 LEVETIRACETAM Levipil Sun Pharma Tablet 500 mg POM EA 08.10.2017 -

Laboratories Ltd,India 31.07.2019

71 P2548 LEVETIRACETAM Levipil Sun Pharma Oral Liquid 100mg/ml POM EA 08.10.2017 -
Laboratories Ltd,India 31.07.2019

72 P3396 LEVOFLOXACIN Glevo Glenmark, India Ear/Eye Drops 0.5% w/v POM EA 08.10.2017 -
31.07.2019

73 P1755 LEVONOGESTREL + Ovral L Pfizer Limited/India Tablet 0.03mg + 0.15mg POM EA E 08.10.2017 -
ETHINYL ESTRADIOL 31.07.2019

74 P3571 LIDOCAINE Xylocaine Astra Zeneca,Sweden Spray 10 mg / in 50 ml Restricted for EA 08.10.2017 -

Hospital use only 31.07.2019

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 9 of 17 Authorized by:DG,MFDA
75 P2921 LIGNOCAINE Lox 2% Neon Laboratories Injection 2% in 20ml Restricted for EA E 08.10.2017 -
Limited, India Hospital/Instituti 31.07.2019
onal use only

76 P82 LIGNOCAINE (LIDOCAINE) Wocaine Wockhardt, India Gel 2% POM EA E 08.10.2017 -

31.07.2019

77 P56 LIGNOCAINE (LIDOCAINE) Lox Neon Laboratories, Topical Ointment 5% POM EA E 08.10.2017 -
India 31.07.2019

78 P2840 LIGNOCAINE + ADRENALIN Lox 2% Adrenalin Neon Laboratories, Injection 2% Restricted for EA 08.10.2017 -
India Hospital use only 31.07.2019

79 P2927 MAGNESIUM SULPHATE Magneon Neon Laboratories, Injection 250mg/ml Restricted for EA E 08.10.2017 -
India Hospital use only 31.07.2019

80 P1710 MAGNESIUM SULPHATE Magnessium Sulphate Vulcan Labaratories Injection 500 mg/ml Restricted for EA E 08.10.2017 -
,India Hospital use only 31.07.2019

81 P1709 MAGNESIUM SULPHATE Magnesium Sulphate Vulcan Labaratories, Injection 250mg/ml Restricted for EA E 08.10.2017 -
India Hospital use only 31.07.2019

82 P1660 MEDROXYPROGESTERONE Depo-Provera Pfizer Manufacturing Injection 150 mg/ml POM EA E 08.10.2017 -
Belgium NV - Belgium 31.07.2019

83 P2476 MEROPENEM Icubac Sandoz Pvt Ltd,India Injection 500 mg POM EA 08.10.2017 -
31.07.2019

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 10 of 17 Authorized by:DG,MFDA
84 P2477 MEROPENEM Mero 1 Aristo Pharmaceuticals Injection 1g POM EA 08.10.2017 -
Pvt. Ltd. INDIA 31.07.2019

85 P1206 METHYLERGOMETRINE Methergin Korten Pharmaceuticals Injection 0.2 mg/ml Restricted for EA E 08.10.2017 -
Pvt Limited,India Hospital use only 31.07.2019

86 P1667 METHYLPREDNISOLONE Solu-Medrol Pharmacia & Upjohn Injection 1 gm/vial (8ml) POM EA E 08.10.2017 -
Company / USA 31.07.2019

87 P1668 METHYLPREDNISOLONE Solu-Medrol Pharmacia & Upjohn Injection 500mg/vial (4ml) POM EA E 08.10.2017 -
SODIUM SUCCINATE Company / USA 31.07.2019

88 P2468 Metoprolol Betaloc Astra Zeneca India Injection 1mg/ml Restricted for EA 08.10.2017 -
Hospital use only 31.07.2019

89 P88 METOPROLOL Metolar Cipla India Tablet 50 mg POM EA E 08.10.2017 -

31.07.2019

90 P3013 METOPROLOL Metolar Cipla India Tablet 25mg POM EA E 08.10.2017 -

31.07.2019

91 P1394 MICONAZOLE NITRATE IP + Zole F MEPROMAX Topical Ointment 2%w/w + POM EA 08.10.2017 -
FLUOCINOLONE ACETONIDE IP LIFESCIENCES PVT.LTD., 0.01%w/w 31.07.2019
INDIA

92 P3219 MICRONISED PROGESTERONE SUSTEN 200 Akums Drugs and Soft Gelatin 200mg POM EA 08.10.2017 -
pharmaceuticals Ltd., / Capsule 31.07.2019
INDIA

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 11 of 17 Authorized by:DG,MFDA
93 P2613 MINOXIDIL + AMINEXIL Hair 4 U Glenmark , India Spray/Solution 5% w/v + 1.5 % POM EA 08.10.2017 -
w/v 31.07.2019

94 P2614 MINOXIDIL + AMINEXIL Hair 4 U Glenmark Spray 10%w/v + 1.5% POM EA 08.10.2017 -
Pharmaceuticals Ltd., w/v 31.07.2019
INDIA

95 P2062 MIRTAZAPINE Mirtaz Sun Pharma Tablet 15 mg POM EA 08.10.2017 -

Laboratories,India 31.07.2019

96 P2839 MISOPROSTOL Zitotec 200 Sun Pharma Tablet 200 mcg Restricted for EA 08.10.2017 -
Laboratories, India Hospital use only 31.07.2019

97 P3177 MOMETASONE FUROATE + Momate F Glenmark , India Cream 0.1% w/w + POM EA 08.10.2017 -
FUSIDIC ACID 2% w/w 31.07.2019

98 P3402 N-ACETYLCYSTEINE Mucinac 600 CIPLA LIMITED, INDIA Effervescent tablet 600 mg POM EA 08.10.2017 -
31.07.2019

99 P3224 NICOTINE POLACRILEX USP 2baconil Candico (l) Ltd, India Chewing Gum 4 mg POM EA E 08.10.2017 -
31.07.2019

100 P3768 NICOTINE USP 2baconil TTS20 Rusan Pharma Ltd, India Transdermal Patch 35.0 mg (14 POM EA 08.10.2017 -
mg/24h) 31.07.2019

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 12 of 17 Authorized by:DG,MFDA
101 P3769 NICOTINE USP 2baconil TTS30 Rusan Pharma Ltd, India Transdermal Patch 52.5mg POM EA 08.10.2017 -
(21mg/24h) 31.07.2019

102 P2574 NORADRENALINE Adrenor Samarth,India Injection 2mg/ml Restricted for EA E 08.10.2017 -
Hospital/Instituti 31.07.2019
onal use only

103 P1754 NORGESTREL + ETHINYL Ovral G Pfizer Limited/India Tablet 0.05mg + 0.5mg POM EA E 08.10.2017 -
ESTRADIOL 31.07.2019

104 P3891 OFLOXACIN USP + O2 Medley Pharmaceuticals Tablet 200mg + 500mg POM TA 08.10.2017 -
ORNIDAZOLE Ltd, India 31.07.2019

105 P2837 OXYTOCIN Syntocinon Korten Pharmaceuticals Injection 5 IU/ml Restricted for EA E 08.10.2017 -
Pvt Limited,India Hospital use only 31.07.2019

106 P3130 OXYTOCIN Evatocin Neon Laboratories, Injection 5 IU/ml Restricted for EA E 08.10.2017 -
India Hospital use only 31.07.2019

107 P2929 PANCURONIUM Neocuron Neon Laboratories, Injection 4 mg /2 ml Restricted for EA E 08.10.2017 -
India Hospital use only 31.07.2019

108 P2139 PANTOPRAZOLE Zepoxin Neon Laboratories Injection 40mg/vial POM EA 08.10.2017 -
Limited, INDIA 31.07.2019

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 13 of 17 Authorized by:DG,MFDA
109 P2887 PARACETAMOL Kabimol Fresenius Kabi India Pvt. Injection 10 mg/ml POM EA 08.10.2017 -
Limited., INDIA. (100mg/10ml, 31.07.2019
500mg/50ml) Each Shipment
should be
accompanied by
the batch
certificates

110 P2461 Phospholipids + Sodium Survanta M/s, AbbVie Inc. 1401, Injection 25mg + 9mg / ml Restricted for EA 08.10.2017 -
chloride Sheridon Road, North Hospital use only 31.07.2019
Chicago, II, 60064 USA
(Marketed by M/s.
Abbott India Ltd)

111 P3131 PHYTOMENADIONE (VITAMIN KENADION 1 Samarth Life Sciences Injection 1 mg/0.5 ml POM EA E 08.10.2017 -
K1) Pvt. Ltd., India 31.07.2019

112 P1711 POTASSIUM CHLORIDE Potassium Chloride Vulcan Labaratories Injection 150 mg Restricted for EA E 08.10.2017 -
,India Hospital use only 31.07.2019

113 P1759 PREDNISOLONE Wysolone Pfizer Limited India Dispersible Tablet 10 mg POM EA E 08.10.2017 -
31.07.2019

114 P1446 PROMETHAZINE Phenergan Nitin Lifesciences Injection 25 mg/ml POM EA E 08.10.2017 -
Lts,India 31.07.2019

115 P1450 PROMETHAZINE IP PHENERGAN ABBOTT HEALTHCARE Oral Liquid 5 mg / 5 ml OTC EA E 08.10.2017 -
PVT. LTD., INDIA 31.07.2019

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 14 of 17 Authorized by:DG,MFDA
116 P111 PROPOFOL PROPOFOL Bharat Serum and Injection 10mg/ml Restricted for EA 08.10.2017 -
Vaccines Limited, India Hospital use only 31.07.2019

117 P2931 PROPOFOL PROPOFOL Bharat Serum and Injection 20mg/ml Restricted for EA E 08.10.2017 -
Vaccines Limited, India Hospital use only 31.07.2019

118 P1580 SALICYLIC ACID + LACTIC ACID Duofilm Stiefel Laboratories Topical Solution 16.7% + 6.7% POM EA E 08.10.2017 -
(IRU) Ltd , Ireland 31.07.2019

119 P3179 SERTACONAZOLE Onabet Glenmark , India Lotion 2% POM EA 08.10.2017 -

31.07.2019

120 P2061 SERTRALINE HYDROCHLORIDE Zosert 50 Sun Pharma Tablet 50 mg POM EA 08.10.2017 -
IP Laboratories Ltd., India 31.07.2019

121 P2721 SEVOFLURANE Sevorane Aesica Queen Borough Solution 100% Restricted for EA 08.10.2017 -
Ltd , UK Hospital use only 31.07.2019

122 P2138 SODIUM CHLORIDE Nasoclear Cadila Health Care India Nasal Spray 0.65%w/v POM EA 08.10.2017 -
31.07.2019

123 P2535 SODIUM CHLORIDE INFUTEC NS INFUTEC HEALTH CARE (For Irrigation Use 0.9% w/v (03 POM PP 08.10.2017 - Each
IRRIGATION (NS) LTD., INDIA Only) litres) 31.07.2019 Shipment
should be
accompanied
by the batch
certificates

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 15 of 17 Authorized by:DG,MFDA
124 P1188 SODIUM DIHYDROGEN Process Proctoclysis Transflex Jawahar Nagar Rectal Solution 10% w/v + 8% POM EA 08.10.2017 -
PHOSPHATE DIHYDROGEN + / India w/v in 100 ml 31.07.2019
DISODIUM

125 P3741 SODIUM VALPORATE Valparin Sanofi-Synthelabo India Oral Liquid 200 mg/5ml POM EA E 08.10.2017 -
Pvt. Ltd 31.07.2019

127 P3098 Surfactant Neosurf Cipla India injection 3 ml Restricted for EA 08.10.2017 -
(Phospholipids) Hospital use only 31.07.2019

128 P2763 Tacrolimus Pangraf Panacea Biotec Ltd, Capsule 0.5 mg POM EA 08.10.2017 -
India. 31.07.2019

129 P2764 Tacrolimus Pangraf Panacea Biotec Ltd, Capsule 1 mg POM EA 08.10.2017 -
India. 31.07.2019

130 P2767 Tacrolimus Tacroz Forte Glenmark , India Ointment 0.1% POM EA 08.10.2017 -
31.07.2019

131 P91 TERBUTALINE Terash Bafna Pharmaceuticals Oral Liquid 1.5 mg/5 ml POM EA E 08.10.2017 -
Ltd, India 31.07.2019

132 P1 THIOPENTAL SODIUM Thiosol Neon Laboratories, Injection 500mg Restricted for EA E 08.10.2017 -
India Hospital use only 31.07.2019

133 P1638 THIORIDAZINE Thioril TORRENT Tablet 10mg POM EA 08.10.2017 -

HYDROCHLORIDE PHARMACEUTICALS 31.07.2019
LIMITED, INDIA

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 16 of 17 Authorized by:DG,MFDA
134 P205 TRIAMCINOLONE ACETONIDE Tricort 40 Cadila Pharmaceutical Injection 40 mg/ml POM EA 08.10.2017 -
IP Limited, India 31.07.2019

135 P1750 TRIHEXYPHENIDYL HCL Pacitane Pfizer Limited India Tablet 2 mg POM EA E 08.10.2017 -
31.07.2019

136 P2466 Tubberculin Diluted Tubberculin Diluted Arkray Health care Pvt Reagent 10TU/0.1 ml in 5 Restricted for EA 08.10.2017 -
(Tuberculin PPD I.P. ) (Tuberculin PPD I.P. Ltd,India ( Mantoux Test) ml solution Hospital/Instituti 31.07.2019
onal use only

137 P3770 TUBERCULIN PPD I.P. TUBERCULIN DILUTED Arkray Health care Pvt Reagent 5TU/0.1 ml Restricted for EA 08.10.2017 -
Ltd,India ( Mantoux Test) Hospital/Instituti 31.07.2019
onal use only

138 P500 VANCOMYCIN Vansafe CP VHB Medi Sciences Injection 500mg Restricted for EA E 08.10.2017 -
Hospital use only 31.07.2019

139 P2458 VECURONIUM Neovec Neon Laboratories, Injection 4mg Restricted for EA 08.10.2017 -
India Hospital use only 31.07.2019

140 P1424 VITAMIN E + ALOE VERA Evion MERCK LIMITED, INDIA Cream 1% w/w OTC EA E 08.10.2017 -
31.07.2019

141 P1500 VITAMINS Guardian Catalent Australia Capsule OTC EA E 08.10.2017 -

31.07.2019

142 P1256 XYLOMETAZOLINE Otrivin (P) Norris Medicine Nasal solution 0.05%/10ml POM EA 08.10.2017 -
Limited,India (Spray/Drops) 31.07.2019

1.For the Products in this list where the formulation is mentioned, that specific formulation only can be imported
2.For those products in which the fomulation is not mentioned, the product imported should be of export quality and not specified for a specific market

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 17 of 17 Authorized by:DG,MFDA
 List 4: Pre-Authorization List (PA)
These are in generics and it is mentioned that Pre Authorization has to be taken prior to import. Pre-authorization is an approval taken to import these products and an approval
for one year will be issued.
Serial No

Product Generic name Product name Manufacturer / Dosage form Strength Category / Status Essen Approved Remarks
No Company name Requirement tiality Date

1 P369 A and B – Strains ( Propagated on VACCINE INFLUENZA Injection A and B – Strains POM (Pre- TA E 05.04.2017 -
hen’s eggs) equivalent to, (Propagated on hen’s authorization 31.07.2019
- A/Michigan/45/2015 (H1N1) eggs) equivalent to, required before
/pdm09 like strain (A/Singapore - A/Michigan/45/2015 import)
/GP1908/2015,IVR-180 ) (H1N1) /pdm09 like
- A/HongKong/4801/2014 (H3N2) strain (A/Singapore
Like strain /GP1908/2015,IVR-180)
(A/HongKong/4801/2014X-263B) -
- B/Brisbane /60/2008-like strain - A/HongKong/4801/2014
(B/Brisbane/60/2008, Wild type ) (H3N2) Like strain
(A/HongKong/4801/201
4X-263B)
- B/Brisbane /60/2008-
like strain
(B/Brisbane/60/2008,
Wild type )

2 P410 ABACAVIR Abacavir Tablet 300 mg Restricted and to be PP 07.10.2017 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

3 P411 ABACAVIR Abacavir Oral Liquid 100mg/5ml Restricted and to be PP 07.10.2017 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 1 of 189 Authorized by:DG,MFDA
 4 P2619 ABACAVIR Abacavir Oral Liquid 10 mg/ml Restricted and to be TA 10.07.2012 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

5 P3793 ABCIXIMAB Abciximab Injection 10mg/5ml Restricted for TA 11.10.2016 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
authorization special request
-
required before from a clinician
import)

6 P4258 ABIRATERONE ABIRATERONE - Tablet 250mg POM (Pre- TA 10.04.2018 - Product approved
authorization 31.07.2019 based on a
required before special request
import) from a clinician

7 P3045 ACARBOSE (STARCH, Acarbose (starch, Tablet 25mg POM (Pre- PP E 20.05.2014 - Product approved
MICROCRYSTALLINE CELLULOSE, microcrystalline cellulose, authorization 31.07.2019 based on a
MAGNESIUM STEARATE, AND magnesium stearate, and required before special request
-
COLLOIDAL SILICON DIOXIDE) colloidal silicon dioxide) import) from a clinician

8 P3046 ACARBOSE (STARCH, Acarbose (starch, Tablet 100 mg POM (Pre- PP E 20.05.2014 - Product approved
MICROCRYSTALLINE CELLULOSE, microcrystalline cellulose, authorization 31.07.2019 based on a
MAGNESIUM STEARATE, AND magnesium stearate, and required before special request
-
COLLOIDAL SILICON DIOXIDE) colloidal silicon dioxide) import) from a clinician

9 P3389 ACENOCOUMAROL Acenocoumarol Tablet 2 mg POM (Pre- TA 17.02.2015 - Product approved

authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

10 P3390 ACENOCOUMAROL Acenocoumarol Tablet 3 mg POM (Pre- TA 17.02.2015 - Product approved

authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 2 of 189 Authorized by:DG,MFDA
 11 P1414 ACETYL SALICYLIC ACID ACETYL SALICYLIC ACID Tablet 300 mg POM (Pre- PP E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

12 P2982 ACICLOVIR/ ACYCLOVIR ACYCLOVIR Injection 250mg POM (Pre- PP E 20.05.2014 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

13 P3840 ACICLOVIR/ ACYCLOVIR Acyclovir Injection 25 mg /5 ml POM (Pre- TA 01.11.2016 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

14 P2459 ADENOSINE ADENOSINE - Injection 3 mg/ ml Restricted for TA 09.04.2019 - MTG/RE-MA/Fo

Hospital use only (Pre- 08.04.2020 0012/2019-0004
authorization
required before
import)
15 P2944 ADRENALINE ADREANALINE Injection 1 mg/ml Restricted for PP E 20.05.2014 - Product approved
Hospital/Institutional 31.07.2019 based on a
use only ( Pre- special request
-
Authorization from a clinician
required before
import )
16 P3232 AGOMELATINE Agomelatine Tablet 5 mg POM (Pre- TA 20.01.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

17 P3233 AGOMELATINE Agomelatine Tablet 10 mg POM (Pre- TA 20.01.2015 - Product approved

authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 3 of 189 Authorized by:DG,MFDA
 18 P3407 ALBUTEROL + IPRATROPIUM Albuterol +Ipratropium Inhaler 100mcg/puff POM (Pre- TA 24.03.2015 - Product approved
BROMIDE Bromide authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

19 P3408 ALBUTEROL + IPRATROPIUM Albuterol +Ipratropium Inhaler 200mcg/puff POM (Pre- TA 24.03.2015 - Product approved
BROMIDE Bromide authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

20 P3406 ALBUTEROL + IPRATROPIUM Albuterol +Ipratropium Nebulising 2.5mg + 0.5mg POM (Pre- TA 24.03.2015 - Product approved
BROMIDE Bromide Solution authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

21 P2469 ALENDRONIC ACID / ALENDRONIC ACID Tablet 10 mg POM (Pre- TA 07.10.2017 - Product approved
ALENDRONATE authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

22 P2470 ALENDRONIC ACID / ALENDRONIC ACID Tablet 35 mg POM (Pre- TA E 07.10.2017 - Product approved
ALENDRONATE authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

23 P2471 ALENDRONIC ACID / ALENDRONIC ACID Tablet 70 mg POM (Pre- TA E 07.10.2017 - Product approved
ALENDRONATE authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

24 P4005 ALENDRONIC ACID / Alendronic Acid Tablet 40mg POM (Pre- TA E 08.10.2017 - Product approved
ALENDRONATE authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 4 of 189 Authorized by:DG,MFDA
 25 P4213 ALFUZOSIN HYDROCHLORIDE ALFUZOSIN HYDROCHLORIDE - Tablet 10mg POM (Pre- TA 13.03.2018 - Product approved
authorization 31.07.2019 based on a
required before special request
import) from a clinician

26 P3086 ALPHACALCIDOL / ALFACALCIDOL Alphacalcidol Tablet 0.25mg Restricted for PP E 20.05.2014 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
authorization special request
-
required before from a clinician
import)

27 P3304 ALTEPLASE Alteplase Powder for 2 mg Restricted for TA 10.02.2015 - Product approved
Injection Hospital use only (Pre- 31.07.2019 based on a
authorization special request
-
required before from a clinician
import)

28 P3306 ALTEPLASE Alteplase Powder for 100 mg Restricted for TA 10.02.2015 - Product approved
Injection Hospital use only (Pre- 31.07.2019 based on a
authorization special request
-
required before from a clinician
import)

29 P4006 ALTEPLASE Alteplase Injection 20mg Restricted for TA E 08.10.2017 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
authorization special request
-
required before from a clinician
import)

30 P4007 ALTEPLASE Alteplase Injection 30mg Restricted for TA E 08.10.2017 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
authorization special request
-
required before from a clinician
import)

31 P3305 ALTEPLASE Alteplase Powder for 50 mg Restricted for TA E 10.02.2015 - Product approved
Injection Hospital use only (Pre- 31.07.2019 based on a
authorization special request
-
required before from a clinician
import)

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 5 of 189 Authorized by:DG,MFDA
 32 P1686 ALUMINIUM DIACETATE Aluminium diacetate Solution 13% POM (Pre- PP E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

33 P4008 AMANTADINE Amantadine Tablet 100mg POM (Pre- TA E 08.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

34 P3175 AMBRISENTAN AMBRISENTAN Tablet 5 mg POM (Pre- EA 08.10.2017 - Product approved

authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

35 P3176 AMBRISENTAN AMBRISENTAN Tablet 10 mg POM (Pre- EA 08.10.2017 - Product approved

authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

36 P505 AMIKACIN AMIKACIN Injection 100 mg/ml POM (Pre- PP 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

37 P509 AMIKACIN AMIKACIN Injection 500 mg/2ml (250mg/ml) POM (Pre- PP E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

38 P2974 AMIKACIN AMIKACIN SULPHATE Injection 1 gm Restricted for TA E 20.05.2014 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 6 of 189 Authorized by:DG,MFDA
 39 P982 AMINACRINE HCL + CETRIMIDE AMINACRINE HCL + Cream 0.1g + 0.5 g OTC (Pre- PP 07.10.2017 - Product approved
CREAM CETRIMIDE CREAM Authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

40 P3634 AMINO ACIDS AMINO ACIDS Injections 7% Restricted for TA 19.01.2016 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization Each special request
required before Shipment from a clinician
- import) should be
accompanied
by the batch
certificates

41 P3636 AMINO ACIDS AMINO ACIDS Injections 8% Restricted for TA 19.01.2016 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization Each special request
required before Shipment from a clinician
- import) should be
accompanied
by the batch
certificates

42 P3637 AMINO ACIDS AMINO ACIDS Injections 5% Restricted for TA 19.01.2016 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization Each special request
required before Shipment from a clinician
- import) should be
accompanied
by the batch
certificates

43 P3646 AMINO ACIDS AMINO ACIDS Injections 10% Restricted for TA E 19.01.2016 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization Each special request
required before Shipment from a clinician
- import) should be
accompanied
by the batch
certificates

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 7 of 189 Authorized by:DG,MFDA
 44 P610 AMINOPHYLLINE AMINOPHYLLINE - Injection 25 mg/ml Restricted for TA E 08.10.2017 - MTG/RE-MA/Fo
Hospital use only (Pre- 31.07.2019 0012/2019-0008
authorization
required before
import)
45 P1600 AMIODARONE AMIODARONE Tablet 200 mg POM (Pre- PP E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

46 P3284 AMISULPRIDE Amisulpride Tablet 100 mg POM (Pre- TA 10.02.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

47 P3843 AMLODIPINE + ATENOLOL Amlodipine + Atenolol Tablet 5 mg + 50 mg POM (Pre- TA 01.11.2016 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

48 P4244 AMOROLFINE AMOROLFINE - Medicated Nail 5% w/v POM (Pre- TA 10.04.2018 - Product approved
Lacquer authorization 31.07.2019 based on a
required before special request
import) from a clinician

49 P4245 AMOROLFINE AMOROLFINE - Cream (0.25%) 2.5mg POM (Pre- TA 10.04.2018 - Product approved
authorization 31.07.2019 based on a
required before special request
import) from a clinician

50 P3775 AMORPHOUS HYDROGEL + Amorphous Hydrogel + Gel 32 ppm POM (Pre- TA 11.10.2016 - Product approved
COLLOIDAL SILVER Colloidal Silver authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 8 of 189 Authorized by:DG,MFDA
 51 P3837 AMOXICILLIN + CLAVULANIC Amoxicillin + Clavulanic Acid Tablet 875 mg + 125 mg POM (Pre- TA E 01.11.2016 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

52 P3189 AMPICILLIN + SULBACTAM AMPICILLIN + SULBACTAM Injection 1.5 g (1g+0.5g) POM (Pre- TA 06.11.2014 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

53 P3190 AMPICILLIN + SULBACTAM AMPICILLIN + SULBACTAM Injection 3 g (2g+1g) POM (Pre- TA 06.11.2014 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

54 P417 AMPRENAVIR Amprenavir Oral Liquid 100 mg Restricted and to be PP 07.10.2017 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

55 P418 AMPRENAVIR Amprenavir Oral Liquid 150 mg Restricted and to be PP 07.10.2017 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

56 P419 AMPRENAVIR Amprenavir Oral Liquid 300 mg Restricted and to be PP 07.10.2017 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

57 P4421 ANASTROZOLE ANASTROZOLE Tablet 1mg POM (Pre- TA 19.03.2019 - Product approved
authorization 18.03.2020 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 9 of 189 Authorized by:DG,MFDA
 58 P3053 ANTITETANUS Antitetanus immunoglobulin Injection 250 IU Restricted for PP E 20.05.2014 - Product approved
IMMUNOGLOBULIN (HUMAN) (human) Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

59 P3054 ANTITETANUS Antitetanus immunoglobulin Injection 500IU Restricted for PP E 20.05.2014 - Product approved
IMMUNOGLOBULIN (HUMAN) (human) Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

60 P3346 APIXABAN Apixaban Tablet 2.5mg POM (Pre- TA 17.02.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

61 P3347 APIXABAN Apixaban Tablet 5 mg POM (Pre- TA 17.02.2015 - Product approved

authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

62 P4361 APREPITANT APREPITANT - Capsule 125mg POM (Pre- TA 23.10.2018 - Product approved
authorization 22.10.2019 based on a
required before special request
import) from a clinician

63 P4101 APREPITANT Aprepitant Capsules 150mg Restricted for TA 05.12.2017- Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

64 P4102 APREPITANT Aprepitant Capsules 80mg Restricted for TA 05.12.2017- Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 10 of 189 Authorized by:DG,MFDA
 65 P4103 APREPITANT Aprepitant Capsules 120mg Restricted for TA 05.12.2017- Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

66 P4345 ARIPIPRAZOLE ARIPIPRAZOLE - Tablet 15mg POM (Pre- TA 16.10.2018 - Product

authorization 15.10.2019 approved based
required before on a special
import) request from a
clinician
67 P3243 ARIPIPRAZOLE Aripiprazole Tablet 10 mg Restricted for TA 20.01.2015 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

68 P3244 ARIPIPRAZOLE Aripiprazole Tablet 30 mg Restricted for TA 20.01.2015 - Product approved

Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

69 P4462 ARSENIC TRIOXIDE ARSENIC TRIOXIDE - Concentrated for 1mg/ml Restricted for TA 09.04.2019 - Product approved
solution for Hospital Use Only 08.04.2020 based on a
infusion (Pre-authorization special request
required before from a clinician
import)

70 P4384 ARTEMETHER Artemether - Tablet 80mg Restricted and to be TA E 04.02.2019 - Product approved
used for the National 05.02.2020 based on a
program only (Pre- Essential
Authorization Medicine List
required before 2018
import)

71 P4385 ARTEMETHER Artemether - Injection 80mg Restricted and to be TA E 04.02.2019 - Product approved
used for the National 05.02.2020 based on a
program only (Pre- Essential
Authorization Medicine List
required before 2018
import)

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 11 of 189 Authorized by:DG,MFDA
 72 P351 ARTEMETHER/LUMEFANTRINE Artemether/Lumefantrine Injection 20mg/120mg Restricted and to be PP 07.10.2017 - Product approved
(COARTEM®) (COARTEM®) used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

73 P3836 ARTESUNATE Artesunte Injection 60 mg Restricted for TA 01.11.2016 - Product approved

Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

74 P4386 ARTESUNATE Artesunate - Tablet 150mg Restricted and to be TA E 04.02.2019 - Product approved
used for the National 05.02.2020 based on a
program only (Pre- Essential
Authorization Medicine List
required before 2018
import)

75 P4387 ARTESUNATE Artesunate - Injection 150mg Restricted and to be TA E 04.02.2019 - Product approved
used for the National 05.02.2020 based on a
program only (Pre- Essential
Authorization Medicine List
required before 2018
import)

76 P3845 ASPIRIN + ATORVASTATIN Aspririn + Atorvastatin Capsule 150 mg+ 20 mg POM (Pre- TA 01.11.2016 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

77 P420 ATAZANAVIR Atazanavir - Oral Liquid 100 mg Restricted and to be PP 07.10.2017 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
Authorization from a clinician
required before
import)

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 12 of 189 Authorized by:DG,MFDA
 78 P421 ATAZANAVIR Atazanavir - Oral Liquid 150 mg Restricted and to be PP 07.10.2017 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
Authorization from a clinician
required before
import)

79 P422 ATAZANAVIR Atazanavir - Oral Liquid 300 mg Restricted and to be PP 07.10.2017 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
Authorization from a clinician
required before
import)

80 P2558 ATOMOXETINE ATOMOXETINE Tablet 18 mg POM (Pre- PP E 07.10.2017 - Product approved

authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

81 P2559 ATOMOXETINE ATOMOXETINE Tablet 25 mg POM (Pre- PP E 07.10.2017 - Product approved

authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

82 P2560 ATOMOXETINE ATOMOXETINE Tablet 40 mg POM (Pre- PP 07.10.2017 - Product approved

authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

83 P2561 ATOMOXETINE ATOMOXETINE Tablet 60 mg POM (Pre- PP 07.10.2017 - Product approved

authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

84 P2562 ATOMOXETINE ATOMOXETINE Tablet 100 mg POM (Pre- PP 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 13 of 189 Authorized by:DG,MFDA
 85 P3870 ATORAVASTATIN + ASPIRIN ATORAVASTATIN + ASPIRIN Tablet 10mg +75mg POM (Pre- TA 07.11.2016 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

86 P3067 ATROPINE SULPHATE ATROPINE SULPHATE Eye Drops 1% POM (Pre- PP E 20.05.2014 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

87 P3068 ATROPINE SULPHATE ATROPINE SULPHATE Eye Drops 0.10% POM (Pre- PP E 20.05.2014 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

88 P3069 ATROPINE SULPHATE ATROPINE SULPHATE Eye Drops 0.50% POM (Pre- PP E 20.05.2014 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

89 P2946 ATROPINE SULPHATE Atropine Injection 1mg/ml Restricted for PP E 20.05.2014 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

90 P3871 ATROPINE SULPHATE ATROPINE SULPHATE Tablet 0.6 mg POM (Pre- TA E 07.11.2016 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

91 P2989 AZATHIOPRINE AZATHIOPRINE Injection 100 mg/ml POM (Pre- PP E 20.05.2014 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 14 of 189 Authorized by:DG,MFDA
 92 P3383 AZATHIOPRINE Azathioprine Injection 100 mg Restricted for TA E 17.02.2015 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

93 P3382 AZATHIOPRINE Azathioprine Tablet 100 mg POM (Pre- TA E 17.02.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

94 P3381 AZATHIOPRINE Azathioprine Tablet 75 mg POM (Pre- TA E 17.02.2015 - Product approved

authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

95 P3380 AZATHIOPRINE Azathioprine Tablet 50 mg POM (Pre- TA E 17.02.2015 - Product approved

authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

96 P2956 AZITHROMYCIN AZITHROMYCIN Injection 500mg POM (Pre- TA E 20.05.2014 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

97 P1357 AZITHROMYCIN Azitromycin Capsule 250 mg POM (Pre- PP E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

98 P3892 BASILIXIMAB BASILIXIMAB Injection 20mg Restricted for TA 07.11.2016 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 15 of 189 Authorized by:DG,MFDA
 99 P3058 BCG vaccine BCG vaccine Injection Restricted for PP E 20.05.2014 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

100 P3858 BECLOMETASONE + Beclometasone + Salbutamol Inhaler 100 mcg +50 mg POM (Pre- TA 01.11.2016 - Product approved
SALBUTAMOL authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

101 P4464 BEDAQUILINE FUMERATE BEDAQUILINE FUMERATE - Uncoated Tablet 100mg Restricted and to be TA 09.04.2019 - Product approved
used for the National 08.04.2020 based on a
program only (Pre- special request
Authorization from a clinician
required before
import)

102 P4463 BENDAMUSTINE BENDAMUSTINE - Powder for 2.5mg/ml Restricted for TA 09.04.2019 - Product approved
concentrate for (100mg/40ml) Hospital Use Only 08.04.2020 based on a
solution for (Pre-authorization special request
infusion required before from a clinician
import)

103 P3217 BENZATHINE BENZYLPENICILLIN Benzathine benzylpenicillin Injection 1,200,000 Units POM (Pre- PP E 20.05.2014 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

104 P2952 BENZATHINE BENZYLPENICILLIN Benzathine benzylpenicillin Injection powder for injection: POM (Pre- PP E 20.05.2014 - Product approved
1.44 g benzylpenicillin authorization 31.07.2019 based on a
(=2.4 million IU), in 5-ml required before special request
-
vial import) from a clinician

105 P3030 BENZYL BENZOATE Benzyl benzoate Lotion 25% POM (Pre- PP E 20.05.2014 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 16 of 189 Authorized by:DG,MFDA
 106 P2953 BENZYLPENICILLIN Benzylpenicillin Injection Powder for injection: POM (Pre- PP E 20.05.2014 - Product approved
600 mg (= 1 million IU); authorization 31.07.2019 based on a
3 g (= 5 million IU) required before special request
- (sodium or potassium import) from a clinician
salt) in vial

107 P4009 BETAMETHASONE Betamethasone Ointment 0.05% POM (Pre- TA E 08.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

108 P4010 BETAMETHASONE Betamethasone Cream 0.05% POM (Pre- TA E 08.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

109 P4045 BETAMETHASONE Betamethasone Injection 6mg/ml POM (Pre- TA E 08.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

110 P766 BETAMETHASONE + CHINOFORM BETAMETHASONE + Topical Ointment 0.1% + 3% 15g POM (Pre- PP E 07.10.2017 - Product approved
CHINOFORM ( Betnovate C) authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

111 P765 BETAMETHASONE + BETAMETHASONE + Cream 0.10% w/w + 3.0% w/w POM (Pre- PP E 07.10.2017 - Product approved
CLIOQUINOL CLIOQUINOL authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

112 P3708 BETHANECHOL CHLORIDE Bethanechol Chloride Tablet 25mg POM (Pre- PP 03.05.2016 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 17 of 189 Authorized by:DG,MFDA
 113 P2302 BEVACIZUMAB BEVACIZUMAB Tablet 300 mg POM (Pre- TA 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

114 P4262 BEVACIZUMAB BEVACIZUMAB - Injection 100mg/4ml (25mg/ml) Restricted for TA 10.04.2018 - Product approved
Hospital Use Only 31.07.2019 based on a
(Pre-authorization special request
required before from a clinician
import)

115 P4263 BEVACIZUMAB BEVACIZUMAB - Injection 400mg/16ml (25mg/ml) Restricted for TA 10.04.2018 - Product approved
Hospital Use Only 31.07.2019 based on a
(Pre-authorization special request
required before from a clinician
import)

116 P3860 BICALUTAMIDE BICALUTAMIDE Tablet 50mg POM (Pre- TA 07.11.2016 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

117 P4249 BIPHASIC ISOPHANE INSULIN BIPHASIC ISOPHANE INSULIN - Injection (Penfill) 100IU/ml (70%+30%) POM (Pre- TA 10.04.2018 - Product approved
(INSULIN ASAPART PROTAMINE + (INSULIN ASAPART authorization 31.07.2019 based on a
INSULIN ASAPART) PROTAMINE + INSULIN required before special request
ASAPART) import) from a clinician

118 P4250 BIPHASIC ISOPHANE INSULIN BIPHASIC ISOPHANE INSULIN - Injection (Penfill) 100IU/ml (50% + 50%) POM (Pre- TA 10.04.2018 - Product approved
(INSULIN ASAPART PROTAMINE + (INSULIN ASAPART authorization 31.07.2019 based on a
INSULIN ASAPART) PROTAMINE + INSULIN required before special request
ASAPART) import) from a clinician

119 P4251 BIPHASIC ISOPHANE INSULIN BIPHASIC ISOPHANE INSULIN - Injection (Flex 100IU/ml (50% + 50%) POM (Pre- TA 10.04.2018 - Product approved
(INSULIN ASAPART PROTAMINE + (INSULIN ASAPART pen) authorization 31.07.2019 based on a
INSULIN ASAPART) PROTAMINE + INSULIN required before special request
ASAPART) import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 18 of 189 Authorized by:DG,MFDA
 120 P4248 BIPHASIC ISOPHANE INSULIN BIPHASIC ISOPHANE INSULIN - Injection (Flex 100IU/ml (70%+30%) POM (Pre- TA 10.04.2018 - Product approved
(ISOPHANE INSULIN + BIPHASIC (ISOPHANE INSULIN + pen) authorization 31.07.2019 based on a
INSULIN) BIPHASIC INSULIN) required before special request
import) from a clinician

121 P577 BISACODYL BISACODYL Tablet 10mg POM (Pre- PP E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

122 P3794 BISOPROLOL Bisoprolol Injection 1.25mg POM (Pre- TA 11.10.2016 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

123 P3362 BISOPROLOL FUMARATE Bisoprolol Fumarate Tablet 20 mg POM (Pre- TA 17.02.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

124 P3361 BISOPROLOL FUMARATE Bisoprolol Fumarate Tablet 10 mg POM (Pre- TA 17.02.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

125 P4457 BLEOMYCIN SULPHATE BLEOMYCIN SULPHATE - Powder for 15 units/vial Restricted for TA 09.04.2019 - Product approved
solution for Hospital Use Only 08.04.2020 based on a
injection (Pre-authorization special request
required before from a clinician
import)

126 P3012 BLOOD whole blood and packed Restricted for PP E 20.05.2014 - Product approved
cells Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 19 of 189 Authorized by:DG,MFDA
 127 P4235 BORTEZOMIB BORTEZOMIB - Injection 2mg/vial Restricted for TA 10.04.2018 - Product approved
Hospital Use Only 31.07.2019 based on a
(Pre-authorization special request
required before from a clinician
import)

128 P4236 BORTEZOMIB BORTEZOMIB - Injection 3.5mg/vial Restricted for TA 10.04.2018 - Product approved
Hospital Use Only 31.07.2019 based on a
(Pre-authorization special request
required before from a clinician
import)

129 P4011 BOSENTAN Bosentan Tablet 62.5mg POM (Pre- TA E 08.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

130 P2465 BOVIN ALBUMIN Bovin Albumin Reagent Restricted for PP 07.10.2017 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

131 P4012 BROMOCRIPTIN Bromocriptin Tablet 5mg POM (Pre- TA E 08.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

132 P131 BROMOCRIPTINE BROMOCRIPTINE Tablet 2.5 mg POM (Pre- TA 27.08.2019 - 26.08.2020
authorization
-
required before
import)
133 P72 BUDESONIDE BUDESONIDE Nasal Spray 100 mcg/md POM (Pre- PP 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

134 P73 BUDESONIDE BUDESONIDE Nasal Spray 200 mcg/md POM (Pre- PP 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 20 of 189 Authorized by:DG,MFDA
 135 P74 BUDESONIDE BUDESONIDE Nasal Spray 50 mcg/md POM (Pre- PP 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

136 P75 BUDESONIDE BUDESONIDE Nasal Spray 50 mcg/md POM (Pre- PP 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

137 P3397 BUDESONIDE Budesonide Respule 1 mg POM (Pre- TA 17.02.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

138 P4426 BUDESONIDE BUDESONIDE Sterile nebuliser 0.25mg/ml (2ml) POM (Pre- TA 19.03.2019 - Product approved
suspension authorization 18.03.2020 based on a
required before special request
-
import) from a clinician

139 P2932 BUPIVACAINE Bupivacaine Injection 0.25% Restricted for PP E 07.10.2017 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

140 P2933 BUPIVACAINE Bupivacaine Injection 0.50% Restricted for PP E 07.10.2017 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

141 P2598 BUPRENORPHINE + NALOXONE BUPRENORPHINE + Tablet 2mg + 0.5mg CONTROLLED TA 05.06.2012 - Product approved
NALOXONE (Restricted and only 31.07.2019 based on a
for NDA) ( Pre- special request
-
Authorization from a clinician
required before
import )

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 21 of 189 Authorized by:DG,MFDA
 142 P2599 BUPRENORPHINE + NALOXONE BUPRENORPHINE + Tablet 8mg + 2mg CONTROLLED TA 05.06.2012 - Product approved
NALOXONE (Restricted and only 31.07.2019 based on a
for NDA) ( Pre- special request
-
Authorization from a clinician
required before
import )
143 P3236 BUPROPION Bupropion Tablet 75 mg POM (Pre- TA 20.01.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

144 P3237 BUPROPION Bupropion Tablet 150 mg POM (Pre- TA 20.01.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

145 P2105 BUSPIRONE Buspirone Tablet 10 mg POM (Pre- PP 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

146 P2104 BUSPIRONE Buspirone Tablet 5 mg POM (Pre- PP 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

147 P4013 CABERGOLIN Cabergolin Tablet 0.5mg POM (Pre- TA E 08.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

148 P3965 CABERGOLINE Cabergoline Tablet 0.5mg POM (Pre- TA 30.05.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 22 of 189 Authorized by:DG,MFDA
 149 P1687 CABERGOLINE Cabergoline Tablet 0.25 mg POM (Pre- PP E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

150 P3093 CAFFEINE CITRATE CAFFEINE CITRATE Injection 20 mg/ml POM (Pre- PP E 20.05.2014 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

151 P2639 CAFFEINE CITRATE CAFFEINE CITRATE Oral Liquid 20 mg/ml POM (Pre- TA 02.10.2012 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

152 P1050 CALCIPOTRIOL CALCIPOTRIOL Cream 0.05% POM (Pre- PP E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

153 P1051 CALCIPOTRIOL CALCIPOTRIOL Topical Ointment 0.05% POM (Pre- PP E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

154 P3667 CALCIUM ACETATE Calcium Acetate Tablet 667 mg POM (Pre- TA 23.02.2016 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

155 P4116 CALCIUM CARBONATE (Eqv.to CALCIUM CARBONATE Tablet 500 mg + 250IU OTC (Pre- EA 08.10.2017 -
ELEMENTAL CALCIUM) + (Eqv.to ELEMENTAL Authorization 31.07.2019
-
VITAMIN D3 CALCIUM) + VITAMIN D4 required before
import)
156 P2923 CALCIUM GLUCONATE CALCIUM GLUCONATE Injection 0.1 Restricted for EA E 08.10.2017 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 23 of 189 Authorized by:DG,MFDA
 157 P3851 CALCIUM POLYSTYRENE Calcium Polystyrene Powder (Sachet) 15 g POM (Pre- TA 01.11.2016 - Product approved
SULFONATE Sulfonate authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

158 P4115 CALCIUMCARBONATE + VITAMIN CALCIUMCARBONATE + - Tablet 250 mg + 125IU OTC (Pre- TA 01.02.2017 - Product approved
D3 VITAMIN D3 Authorization 31.07.2019 based on a
required before special request
import) from a clinician

159 P3710 CANAGLIFLOZIN Canagliflozin Tablet 100mg POM (Pre- PP 03.05.2016 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

160 P1478 CAPECITABINE CAPECITABINE - Tablet 500 mg POM (Pre- TA E MTG/RE-MA/Fo

authorization 0012/2019-0008
required before
import)
161 P4219 CARBACHOL CARBACHOL - Injection (IV) 0.01% Restricted for TA 13.03.2018 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
authorization special request
required before from a clinician
import)

162 P3000 CARBIDOPA + LEVODOPA CARBIDOPA + LEVODOPA Tablet 10 mg +100 mg POM (Pre- PP E 20.05.2014 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

163 P3635 CARBOHYDRATES + AMINO CARBOHYDRATES + AMINO Injections 50g ( Amino Acid and Restricted for TA 19.01.2016 - Product approved
ACIDS ( ACIDS ( Taurine + glucose with Hospital use only (Pre- 31.07.2019 based on a
Taurine + Zinc + Organic Zinc + Organic electrolyte) Authorization Each special request
Glycerophosphate) Glycerophosphate) required before Shipment from a clinician
- import) should be
accompanied
by the batch
certificates

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 24 of 189 Authorized by:DG,MFDA
 164 P2399 CARBOPLANTIN Carboplantin Injection 10mg/ml (450mg/45 ml) Restricted for TA 07.10.2017 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

165 P4205 CARBOPLATIN CARBOPLATIN - Injection 150mg Restricted for TA 13.03.2018 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
authorization special request
required before from a clinician
import)

166 P4206 CARBOPLATIN CARBOPLATIN - Injection 450mg Restricted for TA 13.03.2018 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
authorization special request
required before from a clinician
import)

167 P4388 CARBOPLATIN Carboplatin - Injection 50mg/5ml POM (Pre- TA E 04.02.2019 - Product approved
authorization 05.02.2020 based on a
required before Essential
import) Medicine List
2018

168 P4389 CARVEDILOL Carvedilol - Tablet 3.125mg POM (Pre- TA E 04.02.2019 - Product approved
authorization 05.02.2020 based on a
required before Essential
import) Medicine List
2018

169 P3452 CARVEDOL + Carvedol+ Tablet 25 mg and 12.5 mg POM (Pre- TA 24.03.2015 - Product approved
HYDROCHLORTHIAZIDE Hydochlorthiazide authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

170 P3850 CEFIXIME + CLAVULANIC ACID Cefixime + Clavulanic Acid Tablet 200 mg + 125 mg POM (Pre- TA 01.11.2016 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 25 of 189 Authorized by:DG,MFDA
 171 P3849 CEFOPERAZONE + SULBACTAM Cefoperazone + Sulbactam Injection 0.5g + 0.5 g Restricted for TA 01.11.2016 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

172 P3869 CEFOPERAZONE + SULBACTAM CEFOPERAZONE + Injection 1g+1g Restricted for TA 07.11.2016 - Product approved
SULBACTAM Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

173 P718 CEFTAZIDIME CEFTAZIDIME Injection 250 mg POM (Pre- PP E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

174 P1384 CEFTRIAXONE CEFTRIAXONE Injection 500mg/vial POM (Pre- PP E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

175 P3974 CETRORELIX Cetrorelix Injection 0.25mg / vial Restricted for TA 06.06.2017 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

176 P4269 CETUXIMAB CETUXIMAB - Injection 100mg/50ml (2mg/ml) Restricted for TA 10.04.2018 - Product approved
Hospital Use Only 31.07.2019 based on a
(Pre-authorization special request
required before from a clinician
import)

177 P4270 CETUXIMAB CETUXIMAB - Injection 500mg Restricted for TA 10.04.2018 - Product approved
Hospital Use Only 31.07.2019 based on a
(Pre-authorization special request
required before from a clinician
import)

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 26 of 189 Authorized by:DG,MFDA
 178 P2945 CHARCOAL ACTIVATED CHARCOAL ACTIVATED Powder, 50g cans 50 g cans or packs or POM (Pre- PP E 20.05.2014 - Product approved
or packs or 250mg tablet authorization 31.07.2019 based on a
tablets required before special request
-
import) from a clinician

179 P2600 CHLORAL HYDRATE Chloral Hydrate Tablet 707 mg Restricted for TA 07.10.2017 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

180 P2601 CHLORAL HYDRATE Chloral Hydrate Oral Liquid 500 mg/5 ml Restricted for TA 07.10.2017 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

181 P2602 CHLORAL HYDRATE Chloral Hydrate Oral Liquid 200 mg/5 ml Restricted for TA 07.10.2017 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

182 P2603 CHLORAL HYDRATE Chloral Hydrate Suppository 500 mg Restricted for TA 07.10.2017 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

183 P4014 CHLORAL HYDRATE Chloral Hydrate Oral Liquid 250mg/5ml Restricted for TA E 08.10.2017 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

184 P1322 CHLORAMPHENICOL CHLORAMPHENICOL Capsule 500 mg POM (Pre- PP E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 27 of 189 Authorized by:DG,MFDA
 185 P1320 CHLORAMPHENICOL CHLORAMPHENICOL Capsule 250 mg POM (Pre- PP E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

186 P1318 CHLORAMPHENICOL CHLORAMPHENICOL ENT Solution 0.05% POM (Pre- PP E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

187 P1785 CHLORAMPHENICOL CHLORAMPHENICOL Eye Drops 0.05% POM (Pre- PP E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

188 P1319 CHLORAMPHENICOL CHLORAMPHENICOL Eye Ointment 1% POM (Pre- PP E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

189 P1088 CHLORAMPHENICOL Chloramphenicol Injection 1 gm POM (Pre- PP E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

190 P1321 CHLORAMPHENICOL Chloramphenicol Oral Liquid 125 mg POM (Pre- PP E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

191 P3034 Chlorine base compound Chlorine base compound Powder for 0.10% POM (Pre- PP E 20.05.2014 - Product approved
solution authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 28 of 189 Authorized by:DG,MFDA
 192 P343 CHLOROQUINE CHLOROQUINE Tablet 100 mg Restricted and to be PP E 07.10.2017 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

193 P344 CHLOROQUINE CHLOROQUINE Tablet 150 mg Restricted and to be PP E 07.10.2017 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

194 P4390 CHLOROXYLENOL + TRICLOSAN + CHLOROXYLENOL + Cream 0.3% w/w + 0.3%w/w + OTC (Pre- TA E 09.05.2019 - MTG/RE-MA/Fo
EDETIC ACID TRICLOSAN + EDETIC ACID 0.2%w/w authorization 08.05.2020 0012/2019-0004
-
(DETTOL) required before
import)
195 P1465 CHLORPROMAZINE CHLORPROMAZINE Tablet 25 mg POM (Pre- PP E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

196 P3074 CHLORPROMAZINE Chlorpromazine Oral Liquid 25 mg/5ml POM (Pre- PP E 20.05.2014 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

197 P1442 CHLORPROMAZINE CHLORPROMAZINE Injection 50 mg/2ml POM (Pre- PP E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

198 P1441 CHLORPROMAZINE CHLORPROMAZINE Tablet 50 mg POM (Pre- PP E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 29 of 189 Authorized by:DG,MFDA
 199 P3326 CHOLECALCIFEROL Cholecalciferol Sachet 600,000iu/sachet POM (Pre- TA E 10.02.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

200 P375 Cholera Vaccine Dukoral Vaccine Vaccine 3ml single dose with 5.6 Restricted and to be PP E 07.10.2017 - Product approved
sodium Hydrogen used for the National 31.07.2019 based on a
carbonate sachet program only (Pre- special request
- Authorization from a clinician
required before
import)

201 P3410 CHOLESTYRAMINE Cholestyramine Packet 4g POM (Pre- TA 24.03.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

202 P3841 CHOLINE SALICYLATE + Choline Salicylate Gel 9% w/v + 0.02% w/v POM (Pre- TA 01.11.2016 - Product approved
BENZALKONIUM CHLORIDE Bezalkonium Chloride authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

203 P3976 CHORIOGONADOTROPIN ALPHA Choriogonadotropin Alpha Injection 250mcg/0.5ml Restricted for TA 06.06.2017 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

204 P4105 CHROMIUM PICOLINATE + D- Chromium Picolinate + D- Tablet 200mg Restricted for TA 05.12.2017- Product approved
CHIRO-INOSITOL + MYO- chiro-Inositol + Myo-Inositol Hospital use only (Pre- 31.07.2019 based on a
INOSITOL+VITAMIN D3 + Vitamin D3 Authorization special request
-
required before from a clinician
import)

205 P3846 CILINIDIPINE Cilinidipine Tablet 5 mg POM (Pre- TA 01.11.2016 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 30 of 189 Authorized by:DG,MFDA
 206 P3785 CILNIDIPINE Cilnidipine Tablet 10mg POM (Pre- TA 11.10.2016 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

207 P3786 CILNIDIPINE Cilnidipine Tablet 20mg POM (Pre- TA 11.10.2016 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

208 P3327 CILOSTAZOL Cilostazol Tablet 50 mg POM (Pre- TA 10.02.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

209 P3328 CILOSTAZOL Cilostazol Tablet 100 mg POM (Pre- TA 10.02.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

210 P3701 CINACALCET Cinacalcet Tablet 30mg POM (Pre- PP 03.05.2016 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

211 P3702 CINACALCET Cinacalcet Tablet 60mg POM (Pre- PP 03.05.2016 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

212 P3703 CINACALCET Cinacalcet Tablet 90mg POM (Pre- PP 03.05.2016 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 31 of 189 Authorized by:DG,MFDA
 213 P3092 CINNARIZINE CINNARIZINE Tablet 5 mg POM (Pre- PP E 20.05.2014 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

214 P3842 CIPROFLOXACIN + TINIDAZOLE Ciprofloxacin + Tinidazole Tablet 500 mg + 600 mg POM (Pre- TA 01.11.2016 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

215 P4207 CISPLATIN CISPLATIN - Injection 25mg Restricted for TA E 13.03.2018 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
authorization special request
required before from a clinician
import)

216 P4208 CISPLATIN CISPLATIN - Injection 50mg Restricted for TA E 13.03.2018 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
authorization special request
required before from a clinician
import)

217 P4324 CISPLATIN Cisplatin Injection 10mg Restricted for TA E 02.10.2018 - Product approved
Hospital Use Only 01.10.2019 based on a
(Pre-authorization special request
-
required before from a clinician
import)

218 P3830 CITICHOLINE Citicholine Injection 500 mg Restricted for TA 01.11.2016 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

219 P4314 CLARITHROMYCIN Clarithromycin Injection 500mg Restricted for TA 02.10.2018 - Product approved
Hospital Use Only 01.10.2019 based on a
(Pre-authorization special request
-
required before from a clinician
import)

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 32 of 189 Authorized by:DG,MFDA
 220 P4015 CLINDAMYCIN CLINDAMYCIN Vaginal Pessaries 100mg POM (Pre- TA E 08.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

221 P1673 CLINDAMYCIN CLINDAMYCIN Gel 3% w/w POM (Pre- PP 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

222 P1663 CLINDAMYCIN CLINDAMYCIN Lotion 1% POM (Pre- PP 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

223 P1672 CLINDAMYCIN CLINDAMYCIN Topical Solution 3% w/v POM (Pre- PP 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

224 P4347 CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE - Injection 150mg/2ml Restricted for TA 16.10.2018 - Product
Hospital Use Only 15.10.2019 approved based
(Pre-authorization on a special
required before request from a
import) clinician
225 P2082 CLOBAZAM CLOBAZAM Tablet 5 mg CONTROLLED ( Pre- PP 07.10.2017 - Product approved
Authorization 31.07.2019 based on a
required before special request
-
import ) from a clinician

226 P4016 CLOBAZAM Clobazam Oral Liquid 2.5mg/ml CONTROLLED ( Pre- TA E 08.10.2017 - Product approved
Authorization 31.07.2019 based on a
required before special request
-
import ) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 33 of 189 Authorized by:DG,MFDA
 227 P2083 CLOBAZAM CLOBAZAM Tablet 10 mg CONTROLLED ( Pre- PP 07.10.2017 - Product approved
Authorization 31.07.2019 based on a
required before special request
-
import ) from a clinician

228 P2004 CLOBETASOL PROPIONATE + CLOBETASOL PROPIONATE + Cream 20 g 0.050 % (USP) + 2.00 POM (Pre- PP 07.10.2017 - Product approved
GENTAMICIN SULPHATE GENTAMICIN SULPHATE W/W (IP) authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

229 P2006 CLOBETASOL PROPIONATE + CLOBETASOL PROPIONATE + Cream 10 g 0.05%W/W(IP) + 0.10% POM (Pre- PP 07.10.2017 - Product approved
GENTAMICIN SULPHATE GENTAMICIN SULPHATE W/W(IP) authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

230 P358 CLOFAZIME +RIFAMPACIN MDT (MB) child dose Combination 150 mg+ 450 mg + 50 Restricted and to be PP 07.10.2017 - Product approved
+DAPSONE + CLOFAZIMINE Tablets mg + 50 mg + 50 mg used for the National 31.07.2019 based on a
+DAPSONE program only (Pre- special request
- Authorization from a clinician
required before
import)

231 P357 CLOFAZIME +RIFAMPASIN MDT (MB) adult dose Combination 300 mg+ 600 mg + 100 Restricted and to be PP 07.10.2017 - Product approved
+DAPSONE + CLAFAZIMINE Tablets mg + 50 mg + 100 mg used for the National 31.07.2019 based on a
+DAPSONE program only (Pre- special request
- Authorization from a clinician
required before
import)

232 P353 CLOFAZIMINE CLOFAZIMINE Capsule 100 mg Restricted and to be PP E 07.10.2017 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

233 P354 CLOFAZIMINE CLOFAZIMINE Capsule 50 mg Restricted and to be PP E 07.10.2017 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 34 of 189 Authorized by:DG,MFDA
 234 P4214 CLOMIFENE + CO ENZYME Q10 CLOMIFENE + CO ENZYME - Tablet 50mg + 50mg POM (Pre- TA 13.03.2018 - Product approved
Q10 authorization 31.07.2019 based on a
required before special request
import) from a clinician

235 P4017 CLONAZEPAM Clonazepam Tablet 0.125mg CONTROLLED ( Pre- TA E 08.10.2017 - Product approved
Authorization 31.07.2019 based on a
required before special request
-
import ) from a clinician

236 P4018 CLONIDINE Clonidine Tablet 75mcg POM (Pre- TA E 08.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

237 P4019 CLONIDINE Clonidine Tablet 100mcg POM (Pre- TA E 08.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

238 P3829 CLONIDINE HCL Clonidine HCL Injection 150 mcg Restricted for TA 01.11.2016 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

239 P3854 CLONIDINE HCL Clonidine HCL Tablet 100 mcg POM (Pre- TA 01.11.2016 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

240 P3090 CLOTRIMAZOLE + Clotrimazole + Ear Drops POM (Pre- PP E 20.05.2014 - Product approved
HYDROCORTISONE hydrocortisone authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 35 of 189 Authorized by:DG,MFDA
 241 P4020 CLOXACILLIN Cloxacillin Capsule 500mg POM (Pre- TA E 08.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

242 P2102 CLOZAPINE Clozapine Tablet 25 mg POM (Pre- PP 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

243 P2103 CLOZAPINE Clozapine Tablet 100 mg POM (Pre- PP 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

244 P3028 COAL TAR Coal tar Solution 5% POM (Pre- PP E 20.05.2014 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

245 P4241 COAL TAR + SALICYLIC ACID COAL TAR + SALICYLIC ACID - Solution 4.25% w/v + 2%w/v POM (Pre- TA 10.04.2018 - Product approved
authorization 31.07.2019 based on a
required before special request
import) from a clinician

246 P2994 CODEINE Codeine Tablet 20 mg CONTROLLED ( Pre- PP E 20.05.2014 - Product approved
Authorization 31.07.2019 based on a
required before special request
-
import ) from a clinician

247 P2993 CODEINE Codeine Tablet 30 mg CONTROLLED ( Pre- PP E 20.05.2014 - Product approved
Authorization 31.07.2019 based on a
required before special request
-
import ) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 36 of 189 Authorized by:DG,MFDA
 248 P2995 CODEINE Codeine Oral Liquid 5 mg/ml POM (Pre- PP E 20.05.2014 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

249 P3839 COLCHICINE Colchicine Tablet 0.5 mg POM (Pre- TA 01.11.2016 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

250 P3853 COLISTIMETHATE SODIUM Colistimethate Sodium Injection 50 mg Restricted for TA 01.11.2016 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

251 P4255 COLISTIMETHATE SODIUM COLISTIMETHATE SODIUM - Injection 1 IU Restricted for TA 10.04.2018 - Product approved
Hospital Use Only 31.07.2019 based on a
(Pre-authorization special request
required before from a clinician
import)

252 P3187 COLISTIN (Polymixin E) COLISTIN (Polymixin E) Powder for 150 mg Restricted for PP 06.11.2014 - Product approved
injection Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

253 P3867 COLSTRIDIUM BOTULINUM COLSTRIDIUM BOTULINUM Injection 200 Units Restricted for TA 07.11.2016 - Product approved
TOXIN TYPE A TOXIN TYPE A Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

254 P3868 COLSTRIDIUM BOTULINUM COLSTRIDIUM BOTULINUM Injection 100 Units Restricted for TA 07.11.2016 - Product approved
TOXIN TYPE A TOXIN TYPE A Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 37 of 189 Authorized by:DG,MFDA
 255 P1688 CONTRACEPTIVE DEVICE Diaphragm Diaphragm POM (Pre- PP E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

256 P3008 Cryoprecipitate Cryoprecipitate injection 0.90% Restricted for PP E 20.05.2014 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

257 P4021 CYCLOBENZAPRINE Cyclobenzaprine Tablet 15mg POM (Pre- TA E 08.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

258 P4022 CYCLOBENZAPRINE Cyclobenzaprine Tablet 30mg POM (Pre- TA E 08.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

259 P4023 CYCLOPENTOLATE Cyclopentolate Eye Drop 1% POM (Pre- TA E 08.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

260 P1689 CYCLOPENTOLATE HCL Cyclopentolate Eye Drops 0.50% POM (Pre- PP E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

261 P2990 Cyclophosphamide Cyclophosphamide Tablet 25mg POM (Pre- PP E 20.05.2014 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 38 of 189 Authorized by:DG,MFDA
 262 P2991 Cyclophosphamide Cyclophosphamide Tablet 50mg POM (Pre- PP E 20.05.2014 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

263 P2992 CYCLOPHOSPHAMIDE Cyclophosphamide Injection 500mg/ml Restricted for PP E 20.05.2014 - Product approved
Hospital Use Only 31.07.2019 based on a
(Pre-authorization special request
-
required before from a clinician
import)

264 P4256 CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE - Injection 200mg/ vial Restricted for TA 10.04.2018 - Product approved
Hospital Use Only 31.07.2019 based on a
(Pre-authorization special request
required before from a clinician
import)

265 P4257 CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE - Injection 1000mg/ vial Restricted for TA 10.04.2018 - Product approved
Hospital Use Only 31.07.2019 based on a
(Pre-authorization special request
required before from a clinician
import)

266 P2597 CYCLOSERINE Cycloserine Tablet 500 mg Restricted and to be TA 05.06.2012 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

267 P2975 CYCLOSERINE Cycloserine Capsule 250mg Restricted and to be PP E 20.05.2014 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

268 P3445 CYNOCOBALAMIN + PYRIDOXIN + Cynocobalamin + Pryidoxin + Injection 1000 mg+ 100 mg+ 100 Restricted for TA 24.03.2015 - Product approved
THIAMINE Thiamine mg Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 39 of 189 Authorized by:DG,MFDA
 269 P3319 DABIGATRAN Dabigatran Capsule 110mg POM (Pre- TA 10.02.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

270 P3320 DABIGATRAN Dabigatran Capsule 150mg POM (Pre- TA 10.02.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

271 P3321 DABIGATRAN Dabigatran Capsule 75mg POM (Pre- TA 10.02.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

272 P4456 DACARBAZINE DACARBAZINE - Powder for 200mg Restricted for TA 09.04.2019 - Product approved
solution for Hospital Use Only 08.04.2020 based on a
injection (Pre-authorization special request
required before from a clinician
import)

273 P4391 DACLATASVIR Daclatasvir - Tablet 90mg POM (Pre- TA E 04.02.2019 - Product approved
authorization 05.02.2020 based on a
required before Essential
import) Medicine List
2018

274 P3827 DALTEPARIN SODIUM Dalteparine Sodium Injection 5000 IU Restricted for TA 01.11.2016 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

275 P3822 DALTEPARINE SODIUM Dalteparine Sodium Injection 2500 IU Restricted for TA 01.11.2016 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 40 of 189 Authorized by:DG,MFDA
 276 P3172 DANTROLENE SODIUM DANTROLENE SODIUM Injection 20 g Restricted for EA E 08.10.2017 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

277 P3813 DAPOXETINE Dapoxetine Tablet 30 mg POM (Pre- TA 01.11.2016 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

278 P355 DAPSONE DAPSONE Tablet 25 mg Restricted and to be PP E 07.10.2017 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

279 P356 DAPSONE DAPSONE Tablet 50 mg Restricted and to be PP E 07.10.2017 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

280 P2963 DAPSONE DAPSONE Tablet 100 mg Restricted and to be PP E 20.05.2014 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

281 P3825 DARBEPOETIN Darbepoetin Injection 25 mcg/ml Restricted for TA 01.11.2016 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

282 P4420 DECITABINE DECITABINE IV Infusion 50mg/vial Restricted for TA 19.03.2019 - Product approved
Hospital use only (Pre- 18.03.2020 based on a
authorization special request
-
required before from a clinician
import)

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 41 of 189 Authorized by:DG,MFDA
 283 P4024 DEFERASIROX Deferasirox Tablet 125mg POM (Pre- TA E 08.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

284 P4025 DEFERASIROX Deferasirox Tablet 250mg POM (Pre- TA E 08.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

285 P4026 DEFERASIROX Deferasirox Tablet 500mg POM (Pre- TA E 08.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

286 P2527 DEFERIPRONE Deferiprone Capsule 250mg POM (Pre- TA E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

287 P1690 DEFERIPRONE Deferiprone Tablet 500 mg POM (Pre- PP 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

288 P2159 DEFERIPRONE DEFERIPRONE Oral Liquid 100mg/ml POM (Pre- TA MTG/RE-MA/Fo
authorization 0012/2019-0008
-
required before
import)
289 P4316 DEFLAZACORT Deflazacort Tablet 6mg POM (Pre- TA 02.10.2018 - Product approved
authorization 01.10.2019 based on a
required before special request
-
import) from a clinician

290 P4231 DEHYDROEPIANDROSTERONE + DEHYDROEPIANDROSTERON - Capsule 25mg + 1.5mg POM (Pre- TA 10.04.2018 - Product approved
FOLIC ACID E + FOLIC ACID authorization 31.07.2019 based on a
required before special request
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 42 of 189 Authorized by:DG,MFDA
 291 P4232 DEHYDROEPIANDROSTERONE + DEHYDROEPIANDROSTERON - Capsule 75mg + 3mg + 100mg POM (Pre- TA 10.04.2018 - Product approved
MELATONIN + COENZYME Q10 E + MELATONIN + authorization 31.07.2019 based on a
COENZYME Q10 required before special request
import) from a clinician

292 P4465 DELAMANID DELAMANID - Film coated tablet 50mg Restricted and to be TA 09.04.2019 - Product approved
used for the National 08.04.2020 based on a
program only (Pre- special request
Authorization from a clinician
required before
import)

293 P4211 DENOSUMAB DENOSUMAB - Injection 60mg Restricted for TA 13.03.2018 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
authorization special request
required before from a clinician
import)

294 P4077 DESMOPRESSIN Desmopressin Tablet 60mcg POM (Pre- TA 31.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

295 P4078 DESMOPRESSIN Desmopressin Tablet 120mcg POM (Pre- TA 31.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

296 P3298 DESMOPRESSIN Desmopressin Injection 4mcg / ml Restricted for TA 10.02.2015 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

297 P3301 DESMOPRESSIN Desmopressin Nasal Spray 0.1 mg / ml POM (Pre- TA 10.02.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 43 of 189 Authorized by:DG,MFDA
 298 P3302 DESMOPRESSIN Desmopressin Nasal Spray 0.2 mg /ml POM (Pre- TA 10.02.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

299 P3299 DESMOPRESSIN Desmopressin Tablet 0.1 mg POM (Pre- TA 10.02.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

300 P3300 DESMOPRESSIN Desmopressin Tablet 0.2 mg POM (Pre- TA 10.02.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

301 P3303 DESMOPRESSIN Desmopressin Tablet 0.5 mg/ml POM (Pre- TA 10.02.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

302 P4242 DESONIDE DESONIDE - Cream (0.05%) 0.5mg POM (Pre- TA 10.04.2018 - Product approved
authorization 31.07.2019 based on a
required before special request
import) from a clinician

303 P4243 DESONIDE DESONIDE - Lotion (0.05%) 0.5mg POM (Pre- TA 10.04.2018 - Product approved
authorization 31.07.2019 based on a
required before special request
import) from a clinician

304 P1215 DEXAMETHASONE DEXAMETHASONE Eye Drops 1% POM (Pre- PP E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 44 of 189 Authorized by:DG,MFDA
 305 P49 DEXAMETHASONE Dexamethasone Injection 4 mg / ml POM (Pre- PP E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

306 P1216 DEXAMETHASONE DEXAMETHASONE Eye Drops 1% POM (Pre- PP E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

307 P1217 DEXAMETHASONE PHOSPHATE + DEXAMETHASONE Eye Drops 1mg + 5mg + 0.25mg POM (Pre- PP 07.10.2017 - Product approved
CHLORAMPHENICOL +TETRAZOL PHOSPHATE + authorization 31.07.2019 based on a
HCL CHLORAMPHENICOL required before special request
-
+TETRAZOL HCL import) from a clinician

308 P4321 DEXMEDETOMIDINE Dexmedetomidine HCl Injection 100mcg/ml Restricted for TA 02.10.2018 - Product approved
HYDROCHLORIDE (Solution for Hospital Use Only 01.10.2019 based on a
Injection) (Pre-authorization special request
-
required before from a clinician
import)

309 P3006 DEXTRAN DEXTRAN Injection 70% Restricted for PP E 20.05.2014 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

310 P 3547 DEXTROSE Dextrose Injection 50% POM (Pre- TA 08.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

311 P3818 DEXTROSE Dextrose Injection 0.075 Restricted for TA 01.11.2016 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
authorization special request
-
required before from a clinician
import)

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 45 of 189 Authorized by:DG,MFDA
 312 P4210 DIACEREIN + GLUCOSAMINE DIACEREIN + GLUCOSAMINE - Tablet 50mg + 750mg + 250mg POM (Pre- TA 13.03.2018 - Product approved
SULPHATE + SULPHATE + authorization 31.07.2019 based on a
METHYLSULFONYLMETHANE METHYLSULFONYLMETHANE required before special request
import) from a clinician

313 P3820 DIATRIZOATE MEGLUMINE Diatriziate Meglumine Injection 0.65 Restricted for TA 01.11.2016 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
authorization special request
-
required before from a clinician
import)

314 P2068 DIAZEPAM Diazepam Oral liquid Oral Liquid 2mg/5ml CONTROLLED ( Pre- PP 07.10.2017 - Product approved
Authorization 31.07.2019 based on a
required before special request
-
import ) from a clinician

315 P2067 DIAZEPAM Diazepam Rectal Gel Rectal Gel 2 mg/5ml CONTROLLED ( Pre- PP 07.10.2017 - Product approved
Authorization 31.07.2019 based on a
required before special request
-
import ) from a clinician

316 P1691 DIAZEPAM Diazepam Rectal Solution 10 mg/tube CONTROLLED ( Pre- PP E 07.10.2017 - Product approved
Authorization 31.07.2019 based on a
required before special request
-
import ) from a clinician

317 P4217 DICLOXACILLIN SODIUM DICLOXACILLIN SODIUM - Capsule 500mg POM (Pre- TA 13.03.2018 - Product approved
authorization 31.07.2019 based on a
required before special request
import) from a clinician

318 P3814 DICYCLOMINE Dicyclomine Tablet 10 mg POM (Pre- TA 01.11.2016 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 46 of 189 Authorized by:DG,MFDA
 319 P3815 DICYCLOMINE Dicyclomine Tablet 20 mg POM (Pre- TA 01.11.2016 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

320 P4027 DICYCLOMINE Dicyclomine Oral Liquid 10mg/5ml POM (Pre- TA E 08.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

321 P404 DIDANOSINE Didanosine Powder for oral Powder for 100mg Restricted and to be PP 07.10.2017 - Product approved
solution solution used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

322 P405 DIDANOSINE Didanosine Powder for oral Powder for 167 mg Restricted and to be PP 07.10.2017 - Product approved
solution solution used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

323 P406 DIDANOSINE Didanosine Powder for oral Powder for 200 mg Restricted and to be PP 07.10.2017 - Product approved
solution solution used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

324 P407 DIDANOSINE Didanosine Powder for oral Powder for 125mg Restricted and to be PP 07.10.2017 - Product approved
solution solution used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 47 of 189 Authorized by:DG,MFDA
 325 P408 DIDANOSINE Didanosine Powder for oral Powder for 250mg Restricted and to be PP 07.10.2017 - Product approved
solution solution used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

326 P409 DIDANOSINE Didanosine Powder for oral Powder for 400 mg Restricted and to be PP 07.10.2017 - Product approved
solution solution used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

327 P624 DIGOXIN DIGOXIN Injection 0.25 mg/ml Restricted for PP E 07.10.2017 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

328 P3014 DIGOXIN DIGOXIN Tablet 62.5mcg POM (Pre- PP E 20.05.2014 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

329 P4246 DI-HYDRALAZINE SULPHATE DI-HYDRALAZINE SULPHATE - Tablet 25mg POM (Pre- TA 10.04.2018 - Product approved
authorization 31.07.2019 based on a
required before special request
import) from a clinician

330 P4028 DILTIAZEM Diltiazem Ointment 2% POM (Pre- TA E 08.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

331 P4029 DILTIAZEM Diltiazem Injection 25mg/5ml Restricted for TA E 08.10.2017 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 48 of 189 Authorized by:DG,MFDA
 332 P3828 DILTIAZEM HYDROCHLORID Diltiazem HCL Injection 5 mg/ml Restricted for TA E 08.10.2017 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

333 P3821 DILTIAZEM HYDROCHLORIDE Diltiazem Tablet 120 mg POM (Pre- TA 01.11.2016 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

334 P1692 DIMERCAPROL DIMERCAPROL Injection 50 mg/ml in 2-ml Restricted for PP E 07.10.2017 - Product approved
ampule Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

335 P2768 DINOPROSTONE DINOPROSTONE Tablet (Vaginal) 1 mg Restricted for TA E 08.05.2013 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

336 P2769 DINOPROSTONE DINOPROSTONE Tablet (Vaginal) 3mg Restricted for TA E 08.05.2013 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

337 P4404 DINOPROSTONE Dinoprostone - Injection 0.5% Restricted for TA E 04.02.2019 - Product approved
Hospital Use Only 05.02.2020 based on a
(Pre-authorization Essential
required before Medicine List
import) 2018

338 P372 DIPTHERIA TETANUS Diptheria Tetanus Injection ≥5 Lf (≥40IU) POM (Pre- PP E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 49 of 189 Authorized by:DG,MFDA
 339 P1693 DISTIGMINE BROMIDE Distigmine Tablet 5 mg POM (Pre- PP E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

340 P2060 DIVALPROEX DIVALPROEX Tablet 250 mg POM (Pre- PP 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

341 P2544 DIVALPROEX DIVALPROEX Tablet 500 mg POM (Pre- PP 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

342 P4096 DOCETAXEL Docetaxel Injection 20mg Restricted for TA 05.12.2017 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

343 P4097 DOCETAXEL Docetaxel Injection 80mg Restricted for TA 05.12.2017 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

344 P4098 DOCETAXEL Docetaxel Injection 120mg Restricted for TA 05.12.2017 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

345 P4392 DOCETAXEL Docetaxel - Injection 40mg/ml Restricted for TA E 04.02.2019 - Product approved
Hospital use only (Pre- 05.02.2020 based on a
authorization Essential
required before Medicine List
import) 2018

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 50 of 189 Authorized by:DG,MFDA
 346 P3823 DOMPERIDONE + PARACETAMOL Domperidone + Paracetamol Tablet 10 mg + 500 mg POM (Pre- TA 01.11.2016 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

347 P2076 DONEPEZIL DONEPEZIL Tablet 5 mg POM (Pre- PP 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

348 P2077 DONEPEZIL DONEPEZIL Tablet 10 mg POM (Pre- PP 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

349 P3023 DOPAMINE DOPAMINE Injection 40 mg POM (Pre- PP E 20.05.2014 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

350 P1694 DOXAPRAM HCL DOXAPRAM HCL Injection 20mg/ml Restricted for EA E 08.10.2017 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

351 P3826 DOXOPHYLLINE Doxophyline Tablet 400 mg POM (Pre- TA 08.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

352 P4301 DOXORUBICIN DOXORUBICIN Injection 10mg Restricted for TA 24.07.2018 - Product approved
Hospital Use Only 23.07.2019 based on a
(Pre-authorization special request
-
required before from a clinician
import)

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 51 of 189 Authorized by:DG,MFDA
 353 P4091 DOXORUBICIN Doxorubicin Injection 20mg Restricted for TA 05.12.2017 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

354 P4092 DOXORUBICIN Doxorubicin Injection 50mg Restricted for TA 05.12.2017 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

355 P3817 DROTAVERINE HYDROCHLORIDE Drotaverin HCL Tablet 40 mg Restricted for TA 05.12.2017 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

356 P3819 DROTAVERINE HYDROCHLORIDE Drotaverin HCL Injection 40 mg/2 ml Restricted for TA 05.12.2017 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

357 P3411 DULOXETINE Duloxetine Tablet 10 mg POM (Pre- TA 24.03.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

358 P3812 DULOXETINE HYDROCHLORIDE Duloxetine Hydrochloride Capsule 20 mg POM (Pre- TA 05.12.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

359 P3816 DUTASTERIDE Dutasteride Capsule 0.5 mg POM (Pre- TA 05.12.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 52 of 189 Authorized by:DG,MFDA
 360 P387 Efavirenz Efavirenz Capsule 50 mg Restricted and to be PP 07.10.2017 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

361 P388 Efavirenz Efavirenz Capsule 100 mg Restricted and to be PP 07.10.2017 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

362 P389 Efavirenz Efavirenz Capsule 200 mg Restricted and to be PP 07.10.2017 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

363 P386 Efavirenz Efavirenz Tablet 600 mg Restricted and to be PP 07.10.2017 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

364 P390 Efavirenz Efavirenz Oral Liquid 150 mg/5ml Restricted and to be PP 07.10.2017 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

365 P423 Efavirenz+Emtricitabine+Tenofov Efacvirenz+Emtricitabine+Te Tablet 600 mg+200 mg+300 Restricted and to be PP 07.10.2017 - Product approved
ir nofovir mg used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 53 of 189 Authorized by:DG,MFDA
 366 P3709 EFLORNITHINE HYDROCHLORIDE Eflornithine Hydrochloride Cream 13.90% POM (Pre- PP 03.05.2016 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

367 P4304 ELEMENTAL IRON ELEMENTAL IRON Capsule 30mg OTC (Pre- TA 24.07.2018 - Product approved
authorization 23.07.2019 based on a
required before special request
-
import) from a clinician

368 P3038 Elemental Zinc Elemental Zinc Tablet 10 mg POM (Pre- PP E 20.05.2014 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

369 P3039 Elemental Zinc Elemental Zinc Oral Liquid 20 mg per unit dosage POM (Pre- PP E 20.05.2014 - Product approved
forms. authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

370 P4444 EMPAGLIFLOZIN EMPAGLIFLOZIN - Fim coated tablet 10mg POM (Pre- TA 09.04.2019 - Product approved
authorization 08.04.2020 based on a
required before special request
import) from a clinician

371 P4445 EMPAGLIFLOZIN + LINAGLIPTIN EMPAGLIFLOZIN + - Film coated tablet 10mg POM (Pre- TA 09.04.2019 - Product approved
LINAGLIPTIN authorization 08.04.2020 based on a
required before special request
import) from a clinician

372 P413 Emtricitabine Emtricitabine Oral Liquid 100 mg/5ml Restricted and to be PP 07.10.2017 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 54 of 189 Authorized by:DG,MFDA
 373 P412 Emtricitabine Emtricitabine Capsule 200 mg Restricted and to be PP 07.10.2017 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

374 P4030 EMTRICITABINE + RILPIVIRINE + Emtricitabine + Rilpivirine + Tablet 200mg + 25mg + 300mg Restricted and to be TA E 08.10.2017 - Product approved
TENOFOVIR Tenofovir used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

375 P424 Emtricitabine+Tenofovir Emtricitabine+Tenofovir Tablet 200 mg+300mg Restricted and to be PP 07.10.2017 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

376 P51 ENALAPRIL ENALAPRIL Tablet 2.5 mg POM (Pre- PP E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

377 P2450 Enoxaparin Enoxaparin Injection 100mg/ml POM (Pre- PP 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

378 P4031 ENTECAVIR Entecavir Tablet 0.5mg Restricted and to be TA E 08.10.2017 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 55 of 189 Authorized by:DG,MFDA
 379 P4032 ENTECAVIR Entecavir Tablet 1mg Restricted and to be TA E 08.10.2017 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

380 P1708 EPHEDRINE Ephedrine Injection 30mg CONTROLLED ( Pre- PP E 07.10.2017 - Product approved
Authorization 31.07.2019 based on a
required before special request
-
import ) from a clinician

381 P4093 EPIRUBICIN Epirubicin Injection 10mg Restricted for TA 05.12.2017 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

382 P4094 EPIRUBICIN Epirubicin Injection 50mg Restricted for TA 05.12.2017 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

383 P4095 EPIRUBICIN Epirubicin Injection 100mg Restricted for TA 05.12.2017 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

384 P3450 EPLERENONE Eplerenone Tablet 25 mg POM (Pre- TA 24.03.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

385 P3451 EPLERENONE Eplerenone Tablet 50 mg POM (Pre- TA 24.03.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 56 of 189 Authorized by:DG,MFDA
 386 P3795 EPTIFIBATIDE Eptifibatide Injection 20mg/10ml Restricted for TA 11.10.2016 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

387 P3796 EPTIFIBATIDE Eptifibatide Injection 75mg/100ml Restricted for TA 11.10.2016 - Product approved
Hospital use only (Pre- based on a
Authorization special request
-
required before from a clinician
import)

388 P3797 EPTIFIBATIDE Eptifibatide Injection 200mg/10ml Restricted for TA 11.10.2016 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

389 P625 ERGOTAMINE + CYCLIZINE + ERGOTAMINE + CYCLIZINE + Tablet 2mg + 50mg+100mg POM (Pre- PP 07.10.2017 - Product approved
CAFFEINE CAFFEINE authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

390 P3432 ERLOTINIB Erlotinib Tablet 25 mg POM (Pre- TA 24.03.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

391 P3433 ERLOTINIB Erlotinib Tablet 100 mg POM (Pre- TA 24.03.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

392 P3434 ERLOTINIB Erlotinib Tablet 150 mg POM (Pre- TA 24.03.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 57 of 189 Authorized by:DG,MFDA
 393 P3919 ERTAPENEM ERTAPENEM Injection 1g Restricted for TA 07.11.2016 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

394 P2958 ERYTHROMYCIN Erythromycin injection 500mg POM (Pre- PP E 20.05.2014 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

395 P2957 ERYTHROMYCIN Erythromycin Lotion 3% POM (Pre- PP E 20.05.2014 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

396 P1468 ERYTHROMYCIN Erythromycin Oral Liquid 100 mg/5ml POM (Pre- PP E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

397 P2063 ESCITALOPRAM ESCITALOPRAM Tablet 15 mg POM (Pre- PP 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

398 P3075 ESCITALOPRAM ESCITALOPRAM Tablet 5 mg POM (Pre- PP 20.05.2014 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

399 P4033 ESMOLOL Esmolol Injection 10mg/ml Restricted for TA E 08.10.2017 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 58 of 189 Authorized by:DG,MFDA
 400 P3700 ESTRADIOL Estradiol Transdermal 0.025mg POM (Pre- PP 03.05.2016 - Product approved
Patch authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

401 P3773 ESTRADIOL VALERATE Estradiol Valerate Tablet 1mg POM (Pre- TA 11.10.2016 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

402 P3774 ESTRADIOL VALERATE Estradiol Valerate Tablet 2mg POM (Pre- TA 11.10.2016 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

403 P2099 ESZOPICCLONE Eszopicclone Tablet 1 mg POM (Pre- PP 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

404 P2100 ESZOPICCLONE Eszopicclone Tablet 2 mg POM (Pre- PP 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

405 P2101 ESZOPICCLONE Eszopicclone Tablet 3 mg POM (Pre- PP 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

406 P3334 ETANERCEPT Etanercept Injection 50 mg/ml Restricted for TA 10.02.2015 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 59 of 189 Authorized by:DG,MFDA
 407 P3335 ETANERCEPT Etanercept Injection 25 mg/ml Restricted for TA 10.02.2015 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

408 P329 ETHAMBUTOL ETHAMBUTOL Tablet 200mg Restricted and to be PP E 07.10.2017 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

409 P330 ETHAMBUTOL ETHAMBUTOL Tablet 400mg Restricted and to be PP E 07.10.2017 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

410 P331 ETHAMBUTOL ETHAMBUTOL Tablet 600mg Restricted and to be PP E 07.10.2017 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

411 P2964 ETHAMBUTOL ETHAMBUTOL Tablet 100mg Restricted and to be PP E 20.05.2014 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

412 P3032 Ethanol Ethanol Solution 70% POM (Pre- PP E 20.05.2014 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

413 P3697 ETHINYL ESTRADIOL + Ethinyl Estradiol + Tablet 0.02mg + 0.15mg POM (Pre- PP 03.05.2016 - Product approved
DESOGESTREL Desogestrel authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 60 of 189 Authorized by:DG,MFDA
 414 P3698 ETHINYL ESTRADIOL + Ethinyl Estradiol + Tablet 0.03mg + 0.15mg POM (Pre- PP 03.05.2016 - Product approved
DESOGESTREL Desogestrel authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

415 P3699 ETHINYL ESTRADIOL + Ethinyl Estradiol + Tablet 0.03mg + 3mg POM (Pre- PP 03.05.2016 - Product approved
DROSPIRENONE Drospirenone authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

416 P1523 ETHINYL ESTRADIOL + Microgynon 30ED Fe Tablet 0.03mg+ 0.15mg POM (Pre- PP E 07.10.2017 - Product approved
LEVONOGESTREL authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

417 P3041 Ethinylestradiol Ethinylestradiol Tablet 10 mcg POM (Pre- PP E 20.05.2014 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

418 P3042 Ethinylestradiol Ethinylestradiol Tablet 50mcg POM (Pre- PP E 20.05.2014 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

419 P3043 Ethinylestradiol + cypoterone Ethinylestradiol + Tablet 35mcg +2mg POM (Pre- PP E 20.05.2014 - Product approved
acetate cypoterone acetate authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

420 P3040 Ethinylestradiol + norethisterone Ethinylestradiol + Tablet 35 mcg + 1.0 mg POM (Pre- PP E 20.05.2014 - Product approved
norethisterone authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 61 of 189 Authorized by:DG,MFDA
 421 P2976 ETHIONAMIDE ETHIONAMIDE Tablet 125 mg Restricted and to be PP E 20.05.2014 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

422 P2977 ETHIONAMIDE ETHIONAMIDE Tablet 250 mg Restricted and to be PP E 20.05.2014 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

423 P2615 ETHIONAMIDE ETHIONAMIDE Tablet 500 mg Restricted and to be TA 10.07.2012 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

424 P1326 ETHOSUXIMIDE ETHOSUXIMIDE Capsule 250 mg POM (Pre- PP E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

425 P4034 ETHOSUXIMIDE Ethosuximide Oral Liquid 250mg/5ml POM (Pre- TA E 08.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

426 P1716 ETHYL CHLORIDE Ethyl chloride Spray Aerosol 88 gm/ 100 ml POM (Pre- PP E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

427 P4313 ETOMIDATE Etomidate Injection 2mg/ml (20mg/10ml) Restricted for TA 02.10.2018 - Product approved
Hospital Use Only 01.10.2019 based on a
(Pre-authorization special request
-
required before from a clinician
import)

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 62 of 189 Authorized by:DG,MFDA
 428 P587 ETOPHYLLINE THEOPHYLLINE IP + ETOPHYLLINE THEOPHYLLINE - Injection 84.7 mg + 25.3 g per ml POM (Pre- TA 09.05.2019 - MTG/RE-MA/Fo
THEOPHYLLINE HYDRATE IP IP + authorization 08.05.2020 0012/2019-0005
THEOPHYLLINE HYDRATE IP required before
import)
429 P4312 ETOPOSIDE Etoposide Injection 100mg Restricted for TA 02.10.2018 - Product approved
Hospital Use Only 01.10.2019 based on a
(Pre-authorization special request
-
required before from a clinician
import)

430 P4364 ETOPOSIDE ETOPOSIDE - Injection 50mg Restricted for TA 23.10.2018 - Product approved
Hospital Use Only 22.10.2019 based on a
(Pre-authorization special request
required before from a clinician
import)

431 P4449 ETOPOSIDE ETOPOSIDE - Capsule 50mg POM (Pre- TA 09.04.2019 - Product approved
authorization 08.04.2020 based on a
required before special request
import) from a clinician

432 P4259 EVEROLIMUS EVEROLIMUS - Tablet 2.5mg POM (Pre- TA 10.04.2018 - Product approved
authorization 31.07.2019 based on a
required before special request
import) from a clinician

433 P4260 EVEROLIMUS EVEROLIMUS - Tablet 5mg POM (Pre- TA 10.04.2018 - Product approved
authorization 31.07.2019 based on a
required before special request
import) from a clinician

434 P4261 EVEROLIMUS EVEROLIMUS - Tablet 10mg POM (Pre- TA 10.04.2018 - Product approved
authorization 31.07.2019 based on a
required before special request
import) from a clinician

435 P3010 Factor ix Factor ix injection Restricted for PP E 20.05.2014 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 63 of 189 Authorized by:DG,MFDA
 436 P3009 Factor viii concentrate Factor viii concentrate injection Restricted for PP E 20.05.2014 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

437 P3448 FEBUXOSTAT Febuxostat Tablet 40 mg POM (Pre- TA 24.03.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

438 P3449 FEBUXOSTAT Febuxostat Tablet 80 mg POM (Pre- TA 24.03.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

439 P2934 FENTANYL Fentanyl Oral Liquid 2mg/5ml CONTROLLED ( Pre- PP E 20.05.2014 - Product approved
Authorization 31.07.2019 based on a
required before special request
-
import ) from a clinician

440 P2935 FENTANYL Fentanyl Tablet 2mg CONTROLLED ( Pre- PP E 20.05.2014 - Product approved
Authorization 31.07.2019 based on a
required before special request
-
import ) from a clinician

441 P2936 FENTANYL Fentanyl Tablet 5mg CONTROLLED ( Pre- PP E 20.05.2014 - Product approved
Authorization 31.07.2019 based on a
required before special request
-
import ) from a clinician

442 P3866 FENTANYL CITRATE FENTANYL CITRATE Patch 25mcg CONTROLLED ( Pre- TA 07.11.2016 - Product approved
Authorization 31.07.2019 based on a
required before special request
-
import ) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 64 of 189 Authorized by:DG,MFDA
 443 P3446 FERRIC CARBOXYMALTOSE Ferric carboxymaltose Injection 50 mg/ml Restricted for TA 24.03.2015 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

444 P3447 FERRIC CARBOXYMALTOSE Ferric carboxymaltose Injection 750 mg/15 ml Restricted for TA 24.03.2015 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

445 P4323 FERROUS ASCORBATE + ZINC FERROUS ASCORBATE + ZINC Tablet 100mg + 22.5mg + POM (Pre- TA 02.10.2018 - Product approved
SULPHATE + FOLIC ACID SULPHATE + FOLIC ACID 1.5mg authorization 01.10.2019 based on a
required before special request
-
import) from a clinician

446 P4083 FERROUS FUMERATE + FOLIC Ferrous Fumerate + Folic Tablet 1500mcg POM (Pre- TA 31.10.2017 - Product approved
ACID Acid authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

447 P4221 FERROUS FUMERATE + FOLIC FERROUS FUMERATE + FOLIC - Tablet 150mg + 750mcg + POM (Pre- TA 13.03.2018 - Product approved
ACID + ZINC SULPHATE ACID + ZINC SULPHATE 61.8mg authorization 31.07.2019 based on a
required before special request
import) from a clinician

448 P1482 FILGRASTIM (G-CSF) FILGRASTIM (G-CSF) - Injection 30MU/1.0ml POM (Pre- TA 09.06.2019 - MTG/RE-MA/Fo
authorization 08.06.2020 0012/2019-0006
required before
import)
449 P4376 FLOSEAL HEMOSTATIC MATRIX FLOSEAL HEMOSTATIC - Pre-filled syring 2500 IU /5ml Restricted for TA 23.10.2018 - Product approved
(Bovine derived Gelatin Matrix + MATRIX (Bovine derived with applicator Hospital Use Only 22.10.2019 based on a
human derived thrombin Gelatin Matrix + human tip (Pre-authorization special request
component) derived thrombin required before from a clinician
component) import)

450 P4035 FLUCLOXACILLIN Flucloxacillin Oral Liquid 125mg/5ml POM (Pre- TA E 08.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 65 of 189 Authorized by:DG,MFDA
 451 P4036 FLUCLOXACILLIN Flucloxacillin Tablet 250mg POM (Pre- TA E 08.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

452 P4037 FLUCLOXACILLIN Flucloxacillin Tablet 500mg POM (Pre- TA E 08.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

453 P4038 FLUCLOXACILLIN Flucloxacillin Capsule 250mg POM (Pre- TA E 08.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

454 P4039 FLUCLOXACILLIN Flucloxacillin Capsule 500mg POM (Pre- TA E 08.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

455 P4082 FLUCONAZOLE Fluconazole Tablet 100mg POM (Pre- TA E 31.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

456 P2979 FLUCONAZOLE FLUCONAZOLE Injection 2 mg/ml POM (Pre- PP E 20.05.2014 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

457 P2980 FLUCONAZOLE FLUCONAZOLE Oral Liquid 50 mg/5ml POM (Pre- PP E 20.05.2014 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 66 of 189 Authorized by:DG,MFDA
 458 P3865 FLUCONAZOLE FLUCONAZOLE Injection 2mg/ml Restricted for TA 07.11.2016 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

459 P3666 FLUDROCORTISONE ACETATE Fludrocortisone Acetate Tablet 0.1 mg POM (Pre- TA 23.02.2016 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

460 P1497 FLUMAZENIL FLUMAZENIL Injection 100 mcg/ml Restricted for EA E 08.10.2017 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

461 P3181 FLUMAZENIL FLUMAZENIL Injection 200mcg/ml Restricted for EA E 08.10.2017 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

462 P1393 FLUOCINOLONE + MICONAZOLE FLUOCINOLONE + Cream 0.1% w/w + 2% POM (Pre- PP 07.10.2017 - Product approved
MICONAZOLE authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

463 P1190 FLUORESCEIN SODIUM FLUORESCEIN SODIUM Eye Drops 15ml POM (Pre- PP E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

464 P52 FLUPHENAZINE FLUPHENAZINE Injection 25mg/ml POM (Pre- PP E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 67 of 189 Authorized by:DG,MFDA
 465 P3908 FLUPIRTINE FLUPIRTINE Capsule 100MG CONTROLLED ( Pre- TA 07.11.2016 - Product approved
Authorization 31.07.2019 based on a
required before special request
-
import ) from a clinician

466 P42 FLUROMETHALONE FLUROMETHALONE Eye Drops 0.25% in 5ml POM (Pre- PP E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

467 P41 FLUROMETHALONE FLUROMETHALONE Eye Drops 1mg/ml in 5ml POM (Pre- PP E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

468 P3076 Fluvoxamine Maleate Fluvoxamine Maleate Tablet 25 mg Restricted for PP E 20.05.2014 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

469 P3077 Fluvoxamine Maleate Fluvoxamine Maleate Tablet 50mg Restricted for PP E 20.05.2014 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

470 P3241 Fluvoxamine Maleate Fluvoxamine Maleate Tablet 100mg Restricted for TA E 20.01.2015 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

471 P3001 FOLIC ACID FOLIC ACID Tablet 1mg POM (Pre- PP E 20.05.2014 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 68 of 189 Authorized by:DG,MFDA
 472 P3231 Folic Acid + Methyl Cobalamin + Folic Acid + Methyl Tablet 5mg + 1500 cmg POM (Pre- TA 20.01.2015 - Product approved
Thiamine Cobalamin + Thiamine +100mcg authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

473 P4040 FOLINIC ACID / LEUCOVORIN Folinic Acid / Leucovorin Tablet 5mg POM (Pre- TA E 08.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

474 P4041 FOLINIC ACID / LEUCOVORIN Folinic Acid / Leucovorin Tablet 10mg POM (Pre- TA E 08.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

475 P3967 FOLLICLE STIMULATING Follicle Stimulating Hormone Injection 75 IU/vial Restricted for TA 30.05.2017 - Product approved
HORMONE Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

476 P3968 FOLLICLE STIMULATING Follicle Stimulating Hormone Injection 300 IU/vial Restricted for TA 30.05.2017 - Product approved
HORMONE Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

477 P3969 FOLLICLE STIMULATING Follicle Stimulating Hormone Injection 450 IU/vial Restricted for TA 30.05.2017 - Product approved
HORMONE Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

478 P3970 FOLLICLE STIMULATING Follicle Stimulating Hormone Injection 1200 IU/vial Restricted for TA 30.05.2017 - Product approved
HORMONE Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 69 of 189 Authorized by:DG,MFDA
 479 P3230 FONDAPARINUX SODIUM FONDAPARINUX SODIUM Injection 5 mg/0.4ml POM (Pre- TA 20.01.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

480 P3035 Formaldehyde Formaldehyde Solution POM (Pre- PP E 20.05.2014 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

481 P4322 FOSAPREPITANT Fosaprepitant Injection 150mg Restricted for TA 02.10.2018 - Product approved
Hospital Use Only 01.10.2019 based on a
(Pre-authorization special request
-
required before from a clinician
import)

482 P2059 FOSPHENYTOIN FOSPHENYTOIN Injection 75 mg/ml Restricted for PP 07.10.2017 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

483 P4042 FOSPHENYTOIN Fosphenytoin Injection 150mg Restricted for TA E 08.10.2017 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

484 P3007 Fresh Frozen Plasma(FFP) Fresh Frozen Plasma(FFP) injection Restricted for PP E 20.05.2014 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

485 P3025 FRUSEMIDE FRUSEMIDE Tablet 20 mg POM (Pre- PP E 20.05.2014 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 70 of 189 Authorized by:DG,MFDA
 486 P4365 FULVESTRANT FULVESTRANT - Solution for 50mg/ml (250mg/5ml) Restricted for TA 23.10.2018 - Product approved
Injection Hospital Use Only 22.10.2019 based on a
(Pre-authorization special request
required before from a clinician
import)

487 P1562 FURAZOLIDONE FURAZOLIDONE Tablet 100 mg POM (Pre- PP 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

488 P1563 FURAZOLIDONE FURAZOLIDONE Oral Liquid 25 mg/5 ml POM (Pre- PP 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

489 P1327 GABAPENTIN GABAPENTIN Tablet 300mg POM (Pre- PP E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

490 P1328 GABAPENTIN GABAPENTIN Tablet 400mg POM (Pre- PP E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

491 P1443 GAMMA BENZENE GAMMA BENZENE Topical 1% POM (Pre- PP 07.10.2017 - Product approved
HEXACHLORIDE HEXACHLORIDE Suspension authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

492 P3322 GANCYCLOVIR ( Ganciclovir) Gancyclovir Capsule 200mg POM (Pre- TA 10.02.2015 - Product approved
(Ganciclovir) authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 71 of 189 Authorized by:DG,MFDA
 493 P3323 GANCYCLOVIR ( Ganciclovir) Gancyclovir Capsule 400mg POM (Pre- TA 10.02.2015 - Product approved
(Ganciclovir) authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

494 P3324 GANCYCLOVIR ( Ganciclovir) Gancyclovir Injection 500mg Restricted for TA 10.02.2015 - Product approved
(Ganciclovir) Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

495 P3431 GEFITINIB Gefitinib Tablet 250 mg POM (Pre- TA 24.03.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

496 P4419 GEMCITABINE GEMCITABINE Powder for 1.4g/vial Restricted for TA 19.03.2019 - Product approved
infusion Hospital use only (Pre- 18.03.2020 based on a
authorization special request
-
required before from a clinician
import)

497 P2398 GEMCITAMIDE Gemcitamide Injection 200 mg POM (Pre- TA 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

498 P3182 GEMCITAMIDE Gemcitamide Injection 1g POM (Pre- TA 16.09.2014 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

499 P1330 GEMFIBROZIL GEMFIBROZIL Tablet 600mg POM (Pre- PP 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 72 of 189 Authorized by:DG,MFDA
 500 P1331 GEMFIBROZIL GEMFIBROZIL Tablet 900mg POM (Pre- PP 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

501 P1329 GEMFIBROZIL GEMFIBROZIL Capsule 300 mg POM (Pre- PP 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

502 P1418 GENTAMICIN Gentamycin Cream 0.30% POM (Pre- PP E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

503 P1419 GENTAMICIN GENTAMICIN Injection 10mg/ml POM (Pre- PP E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

504 P1420 GENTAMICIN + GENTAMICIN + Eye Drops 0.3% w/v POM (Pre- PP 07.10.2017 - Product approved
HYDROCORTISONE HYDROCORTISONE authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

505 P3779 GLICLAZIDE Gliclazide Modified Release 30mg POM (Pre- TA 11.10.2016 - Product approved
Tablet authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

506 P3780 GLICLAZIDE Gliclazide Modified Release 60mg POM (Pre- TA 11.10.2016 - Product approved
Tablet authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 73 of 189 Authorized by:DG,MFDA
 507 P3771 GLIMEPIRIDE + METFORMIN + Glimepiride + Metformin + Tablet 1mg + 1000mg + 15mg POM (Pre- TA 11.10.2016 - Product approved
PIOGLITAZONE Pioglitazone authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

508 P3772 GLIMEPIRIDE + METFORMIN + Glimepiride + Metformin + Tablet 2mg + 1000mg + 15mg POM (Pre- TA 11.10.2016 - Product approved
PIOGLITAZONE Pioglitazone authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

509 P3899 GLIPIZIDE + METFORMIN GLIPIZIDE + METFORMIN Tablet 5mg +500mg POM (Pre- TA 07.11.2016 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

510 P1695 GLUCAGON Glucagon Injection 1mg/ml POM (Pre- PP E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

511 P3081 Glucose Glucose Injection 10% POM (Pre- PP E 20.05.2014 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

512 P3082 Glucose Glucose Injection 50% POM (Pre- PP E 20.05.2014 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

513 P3083 Glucose with sodium chloride Glucose with sodium Injection 4% + 0.18% POM (Pre- PP E 20.05.2014 - Product approved
chloride authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 74 of 189 Authorized by:DG,MFDA
 514 P3084 Glucose with sodium chloride Glucose with sodium Injection 5% + 0.45% POM (Pre- PP E 20.05.2014 - Product approved
chloride authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

515 P934 GLUTARAL GLUTARAL Solution 2% Restricted for PP E 07.10.2017 - Product approved
Concentrate Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

516 P2998 GLYCERINE Glycerin Suppository 0.5mg OTC (Pre- PP E 20.05.2014 - Product approved
Authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

517 P2999 GLYCERINE Glycerin Suppository 1gm OTC (Pre- PP E 20.05.2014 - Product approved
Authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

518 P570 GLYCERYL TRINITRATE Nitroglycerin Capsule 0.8 mg POM (Pre- PP E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

519 P2563 GLYCERYL TRINITRATE Glyceryl Trinitrate Injection 50 mg/5 ml POM (Pre- TA 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

520 P3898 GLYCINE IRRIGATION FLUID GLYCINE IRRIGATION FLUID Infusion 1.5% w/v Restricted for TA 07.11.2016 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 75 of 189 Authorized by:DG,MFDA
 521 P1192 GLYCOPYRRONIUM GLYCOPYRRONIUM Injection 200 mcg/ml Restricted for PP E 07.10.2017 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

522 P3417 GOLIMUMAB Golimumab Injection 50 mg/ 0.5 ml Restricted for TA 24.03.2015 - Product approved
(Prefilled) Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

523 P3429 GOSERELIN Goserelin Implant 3.6 mg Restricted for TA 24.03.2015 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

524 P3430 GOSERELIN Goserelin Implant 10.8 mg Restricted for TA 24.03.2015 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

525 P3884 GRANISETRON GRANISETRON Injection 1 mg /ml (in 3 ml) Restricted for TA 07.11.2016 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

526 P3073 Haemodialysis concentrate Haemodialysis concentrate IV Restricted for PP E 20.05.2014 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

527 P904 HALOTHANE HALOTHANE Solution 30ml Restricted for EA E 08.10.2017 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 76 of 189 Authorized by:DG,MFDA
 528 P905 HALOTHANE HALOTHANE Solution 50ml Restricted for EA E 08.10.2017 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

529 P3002 HEPARIN HEPARIN Injection 1000IU POM (Pre- PP E 20.05.2014 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

530 P3003 HEPARIN HEPARIN Injection 20000IU POM (Pre- PP E 20.05.2014 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

531 P589 HEPARIN SODIUM IP + BENZYL HEPARIN SODIUM IP + - Ointment 50 IU + 2 mg + 1.97 mg OTC (Pre- TA E 09.04.2019 - MTG/RE-MA/Fo
NICOTINATE IP + SORBIC ACID IP BENZYL NICOTINATE IP + (20g tube) authorization 08.04.2020 0012/2019-0004
(AS A PRESERVATIVE) SORBIC ACID IP (AS A required before
PRESERVATIVE) import)
532 P376 Hepatitis B Vaccine Hepatitis B Injection Restricted and to be PP E 07.10.2017 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

533 P1696 HOMATROPINE Homatropine Eye Drops 1% POM (Pre- PP E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

534 P3011 HUMAN ALBUMIN HUMAN ALBUMIN Injection 5% Restricted for PP E 20.05.2014 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 77 of 189 Authorized by:DG,MFDA
 535 P937 HUMAN ANTI D HUMAN ANTI D Injection 300mcg POM (Pre- PP E 07.10.2017 - Product approved
IMMUNOGLOBULIN IMMUNOGLOBULIN authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

536 P2456 Hyaluronidase Hyaluronidase Injection 750000IU Restricted for PP 07.10.2017 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

537 P2457 Hyaluronidase Hyaluronidase Injection 1500000 IU Restricted for PP 07.10.2017 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

538 P1298 HYDRALAZINE HYDRALAZINE Injection 20 mg/ml Restricted for PP E 07.10.2017 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

539 P1297 HYDRALAZINE HYDRALAZINE Tablet 25 mg Restricted for PP E 07.10.2017 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

540 P3020 HYDRALAZINE HYDRALAZINE Tablet 50 mg Restricted for PP E 20.05.2014 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

541 P3021 Hydrochlorothiazide Hydrochlorothiazide Tablet 12.5 mg POM (Pre- PP E 20.05.2014 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 78 of 189 Authorized by:DG,MFDA
 542 P3022 Hydrochlorothiazide Hydrochlorothiazide Tablet 25mg POM (Pre- PP E 20.05.2014 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

543 P1756 HYDROCORTISONE Hydrocortisone Injection 25 mg/ml POM (Pre- PP E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

544 P1757 HYDROCORTISONE Hydrocortisone Injection 50 mg/ml POM (Pre- PP E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

545 P702 HYDROCORTISONE Hydrocortisone Topical Ointment 0.50% POM (Pre- PP E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

546 P3485 HYDROCORTISONE Hydrocortisone Tablet 20 mg POM (Pre- TA 10.02.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

547 P3788 HYDROCORTISONE Hydrocortisone Tablet 5mg POM (Pre- TA 11.10.2016 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

548 P3789 HYDROCORTISONE Hydrocortisone Tablet 10mg POM (Pre- TA 11.10.2016 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 79 of 189 Authorized by:DG,MFDA
 549 P3922 HYDROCORTISONE HYDROCORTISONE Tablet 5MG POM (Pre- TA 07.11.2016 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

550 P3923 HYDROCORTISONE HYDROCORTISONE Tablet 10MG POM (Pre- TA 07.11.2016 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

551 P3033 HYDROGEN PEROXIDE Hydrogen Peroxide Solution 6% POM (Pre- PP E 20.05.2014 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

552 P4311 HYDROXOCOBALAMIN Hydroxocobalamin Solution for 1000mg/ml Restricted for TA 02.10.2018 - Product approved
Injection Hospital Use Only 01.10.2019 based on a
(Pre-authorization special request
-
required before from a clinician
import)

553 P2943 HYDROXYCHLOROQUINE HYDROXYCHLOROQUINE Tablet 200 mg POM (Pre- PP E 20.05.2014 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

554 P3852 HYDROXYENTHYL STARCH + Hydroxyenthyl Starch + Injection 6% ( POM (Pre- TA 01.11.2016 - Product approved
SODIUM CHLORIDE Sodium chloride 130/0.4 in 0.9%) authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

555 P4106 HYDROXYETHYL STARCH + Hydroxyethyl starch + Injection 6 g +0.463 g + 0.602 g Restricted for TA 05.12.2017 - Product approved
SODIUM ACETATE TRIHYDRATE + Sodium acetate Trihydrate + +0.03 g +0.03 g + 137 Hospital use only (Pre- 31.07.2019 based on a
SODIUM CHLORIDE + POTASSIUM Sodium chloride + Potassium mmol +4 mmol+1.5 Authorization special request
CHLORIDE + MAGNESIUM chloride + Magnesium mmol+110 mmol required before from a clinician
-
CHLORIDE HEXAHYDRATE + chloride hexahydrate + import)
SODIUM + POTASSIUM + Sodium + Potassium +
MAGNESIUM + CHLORIDE . Magnesium + chloride .

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 80 of 189 Authorized by:DG,MFDA
 556 P532 HYDROXYPROPYL HYDROXYPROPYL - Injection 2% HPMC POM (Pre- PP E
METHYLCELLULOSE METHYLCELLULOSE authorization
required before
import)
557 P531 HYDROXYPROPYL- HYDROXYPROPYL- - Eye Drops 0.7% w/v + 0.19% w/v + POM (Pre- PP E
METHYLCELLULOSE IP + BORAX METHYLCELLULOSE IP + 0.19% w/v + 0.45% w/v authorization
BP +BORIC ACID IP + SODIUM BORAX BP +BORIC ACID IP + + 0.37% w/v + 0.01% required before
CHLORIDE IP + POTASSIUM SODIUM CHLORIDE IP + w/v (5ml) import)
CHLORIDE IP + BENZALKONIUM POTASSIUM CHLORIDE IP +
CHLORIDE (AS PRESERVATIVE) BENZALKONIUM CHLORIDE
(AS PRESERVATIVE)

558 P3441 HYDROXYUREA Hydroxyurea Capsule 200 mg POM (Pre- TA 24.03.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

559 P3442 HYDROXYUREA Hydroxyurea Capsule 300 mg POM (Pre- TA 24.03.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

560 P3443 HYDROXYUREA Hydroxyurea Capsule 400 mg POM (Pre- TA 24.03.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

561 P3437 HYDROXYUREA Hydroxyurea Tablet 200 mg POM (Pre- TA 24.03.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

562 P3438 HYDROXYUREA Hydroxyurea Tablet 300 mg POM (Pre- TA 24.03.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 81 of 189 Authorized by:DG,MFDA
 563 P3439 HYDROXYUREA Hydroxyurea Tablet 400 mg POM (Pre- TA 24.03.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

564 P3440 HYDROXYUREA Hydroxyurea Tablet 500 mg POM (Pre- TA 24.03.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

565 P3444 HYDROXYUREA Hydroxyurea Capsule 500 mg POM (Pre- TA 24.03.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

566 P3742 HYOSCINE BUTYLBROMIDE HYOSCINE BUTYLBROMIDE Injection 20 mg/ml POM (Pre- PP E 30.08.2016 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

567 P4043 HYPROMELLOSE Hypromellose Opthalmic Gel 0.30% OTC (Pre- TA E 08.10.2017 - Product approved
Authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

568 P4450 IBANDRONIC ACID IBANDRONIC ACID - Film coated tablet 50mg POM (Pre- TA 09.04.2019 - Product approved
authorization 08.04.2020 based on a
required before special request
import) from a clinician

569 P3094 Ibuprofen Ibuprofen Injection 5 mg/ml Restricted for PP E 20.05.2014 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 82 of 189 Authorized by:DG,MFDA
 570 P3740 IBUPROFEN IBUPROFEN Oral Liquid 100 mg /5 ml OTC (Pre- PP E 30.08.2016 - Product approved
Authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

571 P4460 IFOSFAMIDE IFOSFAMIDE - Powder for 1g (each milliliter of Restricted for TA 09.04.2019 - Product approved
concentrate for concentrate contains Hospital Use Only 08.04.2020 based on a
solution for 80mg Ifosfamide) (Pre-authorization special request
infusion required before from a clinician
import)

572 P3378 ILOPROST Iloprost Respule 10 mg/ml Restricted for TA 17.02.2015 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

573 P3379 ILOPROST Iloprost Respule 20 mg/ml Restricted for TA 17.02.2015 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

574 P3425 IMATINIB Imatinib Tablet 100 mg POM (Pre- TA 24.03.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

575 P3426 IMATINIB Imatinib Tablet 400 mg POM (Pre- TA 24.03.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

576 P2954 Imipenen+cilastin Imipenen+ cilastin Injection 250mg+250mg Restricted for PP E 20.05.2014 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 83 of 189 Authorized by:DG,MFDA
 577 P2955 Imipenen+cilastin Imipenen+ cilastin Injection 500mg +500 mg Restricted for PP E 20.05.2014 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

578 P414 Indinavir Indinavir Oral Liquid 400mg Restricted and to be PP 07.10.2017 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

579 P3336 INFLIXIMAB Infliximab Injection 100 mg/20 ml Restricted for TA 10.02.2015 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

580 P3668 INSULIN DEGLUDE Insulin Degludec Injection 100 Units/ ml POM (Pre- TA 23.02.2016 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

581 P3669 INSULIN DEGLUDE Insulin Degludec Injection 200 Units /ml POM (Pre- TA 23.02.2016 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

582 P3044 Insulin glargine Insulin glargine Injection - POM (Pre- PP E 20.05.2014 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

583 P3961 INSULIN GLULISINE INSULIN GLULISINE Injection 100 iu/ml Restricted for TA 14.03.2017 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 84 of 189 Authorized by:DG,MFDA
 584 P1697 IPECAC Oral liquid Oral liquid Ipecac Oral Liquid 0% OTC (Pre- PP E 07.10.2017 - Product approved
Authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

585 P3398 IPRATROPIUM BROMIDE Ipratropium Bromide Solution 500 mcg POM (Pre- TA 05.06.2012 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

586 P4099 IRINOTECAN Irinotecan Injection 100mg Restricted for TA 05.12.2017 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

587 P4100 IRINOTECAN Irinotecan Injection 40mg Restricted for TA 05.12.2017- Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

588 P1362 IRON DEXTRAN Iron Dextran Injection 50mg/ml POM (Pre- PP E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

589 P219 IRON SORBITOL IRON SORBITOL Injection 50 mg Restricted for PP E 07.10.2017 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

590 P3285 IRON SUCROSE Iron Sucrose Injection 100 mg Restricted for TA 10.02.2015 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 85 of 189 Authorized by:DG,MFDA
 591 P3286 IRON SUCROSE Iron Sucrose Injection 200 mg Restricted for TA 10.02.2015 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
authorization special request
-
required before from a clinician
import)

592 P3739 ISOLEUCINE PH.EUR ISOLEUCINE PH.EUR Solution for 0.5G+0.74G+0.931G+0.4 Restricted for TA 19.01.2016 - Product approved
0.5G+LEUCINE PH.EUR 0.74G+ 0.5G+LEUCINE PH.EUR infusion (Adult) 3G+0.51G+0.44G+0.2G+ Hospital use only (Pre- 31.07.2019 based on a
LYSINE ACETATE USP 0.931G + 0.74G+ LYSINE ACETATE USP 0.62G+1.2G+0.3G+1.4G authorization Each special request
LYSIN 0.66G + METHIONINE 0.931G + LYSIN 0.66G + +1.1G+1.12G+0.65G+0.0 required before Shipment from a clinician
PH.EUR 0.43G + PHENYLALANINIE METHIONINE PH.EUR 0.43G + 4G+0.1G (10%) import) should be
PH.EUR 0.51G + THREONINE PHENYLALANINIE PH.EUR accompanied
PH.EUR 0.44G + TRYPTOPHAN 0.51G + THREONINE PH.EUR by the batch
PH.EUR 0.2G + VALINE PH.EUR 0.44G + TRYPTOPHAN certificates
0.62G + ARGININE PH.EUR 1.2G + PH.EUR 0.2G + VALINE
HISTIDINE PH.EUR 0.3G + PH.EUR 0.62G + ARGININE -
ALANINE PH.EUR 1.4G +GLYCINE PH.EUR 1.2G + HISTIDINE
PH.EUR 1.1G + PROLINE PH.EUR PH.EUR 0.3G + ALANINE
1.12G + SERINE PH.EUR 0.65G + PH.EUR 1.4G +GLYCINE
TRYOSINE PH.EUR 0.04G + PH.EUR 1.1G + PROLINE
TAURINE 0.1G PH.EUR 1.12G + SERINE
PH.EUR 0.65G + TRYOSINE
PH.EUR 0.04G + TAURINE
0.1G (Aminoven 10%)

593 P332 ISONIAZID ISONIAZID Tablet 100 mg Restricted and to be PP E 07.10.2017 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

594 P333 ISONIAZID ISONIAZID Tablet 300 mg Restricted and to be PP E 07.10.2017 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 86 of 189 Authorized by:DG,MFDA
 595 P2965 ISONIAZID ISONIAZID Tablet (Scored) 50 mg Restricted and to be PP E 20.05.2014 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

596 P3901 ISOPHANE ISOPHANE Suspention for 40iu /ml Restricted for TA 07.11.2016 - Product approved
injection Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

597 P158 ISORSORBIDE MONONITRATE ISORSORBIDE MONONITRATE - Tablet 10 mg POM (Pre- TA E 09.04.2019 - MTG/RE-MA/Fo
authorization 08.04.2020 0012/2019-0004
required before
import)
598 P1158 ISOSORBIDE DINITRATE Isosorbide Dinitrate Tablet 20 mg POM (Pre- PP 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

599 P4216 ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE - Sustained 30mg POM (Pre- TA 13.03.2018 - Product approved
Released Tablet authorization 31.07.2019 based on a
required before special request
import) from a clinician

600 P2331 ISOTRETINOIN ISOTRETINOIN Capsule 10 mg POM (Pre- TA 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

601 P3405 ITRACONAZOLE Itraconazole Injection 10mg/ml Restricted for TA 24.03.2015 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 87 of 189 Authorized by:DG,MFDA
 602 P3404 ITRACONAZOLE Itraconazole Oral Liquid 10mg/ml POM (Pre- TA 24.03.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

603 P3056 IV immunoglobulin IV immunoglobulin Injection 2.5g/vial Restricted for PP E 20.05.2014 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
authorization special request
-
required before from a clinician
import)

604 P3057 IV immunoglobulin IV immunoglobulin Injection 10g/vial Restricted for PP E 20.05.2014 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

605 P4395 IV IMMUNOGLOBULIN (IVIG) IV Immunoglobulin - Injection 5g/vial Restricted for TA E 04.02.2019 - Product approved
Hospital Use Only 05.02.2020 based on a
(Pre-authorization Essential
required before Medicine List
import) 2018

606 P3792 IVABRADINE Ivabradine Tablet 5mg POM (Pre- TA 11.10.2016 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

607 P2978 Kanamycin Kanamycin Injection 1 gm Restricted for PP E 20.05.2014 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

608 P1590 KETAMINE Ketamine Injection 10 mg / ml CONTROLLED ( Pre- PP E 07.10.2017 - Product approved
Authorization 31.07.2019 based on a
required before special request
-
import ) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 88 of 189 Authorized by:DG,MFDA
 609 P1591 KETAMINE Ketamine Injection 50 mg / ml CONTROLLED ( Pre- PP E 07.10.2017 - Product approved
Authorization 31.07.2019 based on a
required before special request
-
import ) from a clinician

610 P3065 KETOCONAZOLE Ketoconazole Eye Drops 0.30% POM (Pre- PP E 20.05.2014 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

611 P1999 KETOCONAZOLE + ZINC KETOCONAZOLE + ZINC Medicated 2.000% W/V(IP) + 1.00 OTC (Pre- PP 07.10.2017 - Product approved
PYRITHIONE PYRITHIONE Shampoo W/V Authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

612 P3862 KETOROLAC TROMETHAMINE KETOROLAC Injection 30 mg Restricted for TA 07.11.2016 - Product approved
TROMETHAMINE Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

613 P4442 KETOROLAC TROMETHAMINE KETOROLAC - Topical Gel 2% POM (Pre- TA 09.04.2019 - Product approved
TROMETHAMINE authorization 08.04.2020 based on a
required before special request
import) from a clinician

614 P4443 KETOROLAC TROMETHAMINE KETOROLAC - Fim coated tablet 10mg POM (Pre- TA 09.04.2019 - Product approved
TROMETHAMINE authorization 08.04.2020 based on a
required before special request
import) from a clinician

615 P2581 LABETOLOL Lebetolol Injection 10 mg POM (Pre- TA 05.06.2012 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 89 of 189 Authorized by:DG,MFDA
 616 P2582 LABETOLOL Lebetolol Injection 20 mg POM (Pre- TA 05.06.2012 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

617 P2583 LABETOLOL Lebetolol Injection 40 mg POM (Pre- TA 05.06.2012 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

618 P3018 LABETOLOL Lebetolol Tablet 200mg POM (Pre- PP E 20.05.2014 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

619 P3019 LABETOLOL Lebetolol Tablet 300mg POM (Pre- PP E 20.05.2014 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

620 P3016 LABETOLOL Lebetolol Injection 5mg/ml POM (Pre- PP E 20.05.2014 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

621 P3017 LABETOLOL Lebetolol Tablet 100mg POM (Pre- PP E 20.05.2014 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

622 P2641 LACTOBACILLUS LACTOBACILLUS Sachet 2000 L+ 5 mg, +26 mg+ OTC (Pre- EA 08.10.2017 - Product approved
ACIDOPHILUS+CALCIUM ACIDOPHILUS+CALCIUM 1 mcg + 50 mg + 300 Authorization 31.07.2019 based on a
PANTOTHENATE+ NIACINAMIDE PANTOTHENATE+ mcg + 1.5 mg + 3 mg + 2 required before special request
+VITAMIN +VITAMIN C +FOLIC NIACINAMIDE +VITAMIN mg import) from a clinician
-
ACID+VITAMIN B6 + VITAMIN B2 +VITAMIN C +FOLIC
+ THIAMINE MONONITRATE ACID+VITAMIN B6 + VITAMIN
B2 + THIAMINE
MONONITRATE

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 90 of 189 Authorized by:DG,MFDA
 623 P3924 LACTULOSE LACTULOSE Powder , Oral 80g POM (Pre- TA 07.11.2016 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

624 P379 Lamivudine Lamivudine Tablet 150mg Restricted and to be PP 07.10.2017 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

625 P2617 Lamivudine Lamivudine Oral Liquid 10 mg/ml Restricted and to be TA 10.07.2012 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

626 P380 Lamivudine Lamivudine Oral Liquid 50mg/ml Restricted and to be PP 07.10.2017 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

627 P425 Lamivudine+Nevirapine+Stavudin Lamivudine+Nevirapine+Stav Tablet 150mg+200mg+30mg Restricted and to be PP 07.10.2017 - Product approved
e udine used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

628 P426 Lamivudine+Nevirapine+Stavudin Lamivudine+Nevirapine+Stav Tablet 30mg+50mg+6mg Restricted and to be PP 07.10.2017 - Product approved
e udine used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 91 of 189 Authorized by:DG,MFDA
 629 P427 Lamivudine+Nevirapine+Stavudin Lamivudine+Nevirapine+Stav Tablet 60mg+100mg+12mg Restricted and to be PP 07.10.2017 - Product approved
e udine used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

630 P428 Lamivudine+Nevirapine+Zidovudi Lamivudine+Nevirapine+Zido Tablet 30mg+50mg+60mg Restricted and to be PP 07.10.2017 - Product approved
ne vudine used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

631 P429 Lamivudine+Nevirapine+Zidovudi Lamivudine+Nevirapine+Zido Tablet 150mg+200mg+300mg Restricted and to be PP 07.10.2017 - Product approved
ne vudine used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

632 P430 Lamivudine+Zidovudine Lamivudine+Zidovudine Tablet 30mg+60mg Restricted and to be PP 07.10.2017 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

633 P431 Lamivudine+Zidovudine Lamivudine+Zidovudine Tablet 150mg+300mg Restricted and to be PP 07.10.2017 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

634 P1619 LAMOTRIGINE LAMOTRIGINE Tablet 25mg POM (Pre- PP E 05.07.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 92 of 189 Authorized by:DG,MFDA
 635 P2546 LAMOTRIGINE LAMOTRIGINE Tablet 150mg POM (Pre- PP E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

636 P1620 LAMOTRIGINE LAMOTRIGINE Tablet 50mg POM (Pre- PP E 05.07.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

637 P3395 LANSOPRAZOLE + CLINDAMYCIN Lansoprazole+ Capsule 300+300+500 POM (Pre- TA 17.02.2015 - Product approved
+ TINIDAZOLE Clindamycin+Tinidazole authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

638 P3394 LANSOPRAZOLE + CLINDAMYCIN Lansoprazole+ Tablet 300+300+500 POM (Pre- TA 17.02.2015 - Product approved
+ TINIDAZOLE Clindamycin+Tinidazole authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

639 P3191 LANTHANUM CARBONATE LANTHANUM CARBONATE Tablet (Chewable) 500 mg POM (Pre- TA 06.11.2014 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

640 P3192 LANTHANUM CARBONATE LANTHANUM CARBONATE Tablet (Chewable) 750 mg POM (Pre- TA 06.11.2014 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

641 P3897 LANTHANUM CARBONATE LANTHANUM CARBONATE Tablet 250mg POM (Pre- TA 07.11.2016 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 93 of 189 Authorized by:DG,MFDA
 642 P3292 LANTHANUM CARBONATE Lanthanum carbonate Tablet 1000 mg POM (Pre- TA 10.02.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

643 P4254 L-CARNITINE + ACETYLCARNITINE L-CARNITINE + - Oral Powder 0.5mg + 1g + 20mg + POM (Pre- TA 10.04.2018 - Product approved
HYDROCHLORIDE + FRUCTOSE + ACETYLCARNITINE (Sachet) 50mg + 500mcg + authorization 31.07.2019 based on a
COENZYME + CITRIC ACID + FOLIC HYDROCHLORIDE + 2.5mcg + 50mcg + 10mg required before special request
ACID + CYANOCOBALAMIN + FRUCTOSE + COENZYME + + 2.5mg (5gm) import) from a clinician
SELENIUM + ZINC + LYCOPENE CITRIC ACID + FOLIC ACID +
(AMINO ACID + VITAMIN + CYANOCOBALAMIN +
MINERALS + LYCOPENE) SELENIUM + ZINC +
LYCOPENE (AMINO ACID +
VITAMIN + MINERALS +
LYCOPENE)
644 P1444 LECITHIN LECITHIN (Essential L) Capsule 250 mg POM (Pre- PP 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

645 P4393 LEDIPASVIR + SOFOSBUVIR Ledispavir + Sofosbuvir - Tablet 90mg + 400mg Restricted and to be TA E 04.02.2019 - Product approved
used for the National 05.02.2020 based on a
program only (Pre- Essential
Authorization Medicine List
required before 2018
import)

646 P3337 LEFLUNOMIDE Leflunomide Tablet 10 mg POM (Pre- TA 10.02.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

647 P3338 LEFLUNOMIDE Leflunomide Tablet 20 mg POM (Pre- TA 10.02.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 94 of 189 Authorized by:DG,MFDA
 648 P4366 LENALIDOMIDE LENALIDOMIDE - Hard capsule 5mg POM (Pre- TA 23.10.2018 - Product approved
authorization 22.10.2019 based on a
required before special request
import) from a clinician

649 P4367 LENALIDOMIDE LENALIDOMIDE - Hard capsule 10mg POM (Pre- TA 23.10.2018 - Product approved
authorization 22.10.2019 based on a
required before special request
import) from a clinician

650 P4448 LENALIDOMIDE LENALIDOMIDE - Capsule 25mg POM (Pre- TA 09.04.2019 - Product approved
authorization 08.04.2020 based on a
required before special request
import) from a clinician

651 P4089 LEUCOVORIN Leucovorin Injection 50mg Restricted for TA 05.12.2017 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

652 P4090 LEUCOVORIN Leucovorin Injection 15mg Restricted for TA 05.12.2017 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

653 P3913 LEUPROLIDE ACCETATE LEUPROLIDE ACCETATE Injection 45mg Restricted for TA 07.11.2016 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

654 P3914 LEUPROLIDE ACCETATE LEUPROLIDE ACCETATE Injection 22.5mg Restricted for TA 07.11.2016 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 95 of 189 Authorized by:DG,MFDA
 655 P3704 LEUPROLIDE ACETATE Leuprolide Acetate Injection 3.75mg Restricted for PP 03.05.2016 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

656 P2080 LEVETIRACETAM LEVETIRACETAM Tablet 750 mg POM (Pre- PP 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

657 P2547 LEVETIRACETAM LEVETIRACETAM Tablet 10mg POM (Pre- PP 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

658 P3872 LEVETIRACETAM LEVETIRACETAM Injection 500 mg/5 ml Restricted for TA 07.11.2016 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

659 P4253 LEVOCARNITINE LEVOCARNITINE - Tablet 500mg POM (Pre- TA 10.04.2018 - Product approved
authorization 31.07.2019 based on a
required before special request
import) from a clinician

660 P4307 LEVOCETRIZINE LEVOCETRIZINE Oral Liquid 2.5mg/5ml POM (Pre- TA 24.07.2018 - Product approved
authorization 23.07.2019 based on a
required before special request
-
import) from a clinician

661 P361 Levonorgestrel Levonorgestrel Tablet 0.75mg Restricted and to be PP 07.10.2017 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 96 of 189 Authorized by:DG,MFDA
 662 P1043 LEVONORGESTREL LEVONORGESTREL Implant 38mg/Implanted rod Restricted and to be PP E 07.10.2017 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

663 P362 Levonorgestrel Levonorgestrel Tablet 0.03mg Restricted and to be PP 07.10.2017 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

664 P3916 LEVOSALBUTAMOL LEVOSALBUTAMOL Inhaler 50 mcg ( 200 MD) POM (Pre- TA 07.11.2016 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

665 P3917 LEVOSALBUTAMOL LEVOSALBUTAMOL Inhaler 100 mcg (200 MD) POM (Pre- TA 07.11.2016 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

666 P4375 LEVOSIMENDAN LEVOSIMENDAN - Concentrated 12.5mg/5ml Restricted for TA 23.10.2018 - Product approved
Solution for Hospital Use Only 22.10.2019 based on a
Infusion (Pre-authorization special request
required before from a clinician
import)

667 P3353 LEVOSULPRIDE Levosulpiride Tablet 25 mg POM (Pre- TA 17.02.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

668 P4394 LEVOTHYROXINE Levothyroxine - Tablet 75mcg POM (Pre- TA E 04.02.2019 - Product approved
authorization 05.02.2020 based on a
required before Essential
import) Medicine List
2018

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 97 of 189 Authorized by:DG,MFDA
 669 P3050 LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM Tablet 50 mcg POM (Pre- PP E 20.05.2014 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

670 P3051 LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM Tablet 25 mcg POM (Pre- PP E 20.05.2014 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

671 P2628 LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM Tablet 100 mcg POM (Pre- R 18.09.2012 -
authorization 31.07.2019
-
required before
import)
672 P3966 LIDOCAINE (LIGNOCAINE) + LIDOCAINE (LIGNOCAINE) + Cream 25mg + 25mg/g Restricted for TA 30.05.2017 - Product approved
PRILOCAINE PRILOCAINE Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

673 P55 LIGNOCAINE (LIDOCAINE) LIGNOCAINE (LIDOCAINE) Injection 2% POM (Pre- PP E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

674 P81 LIGNOCAINE (LIDOCAINE) LIGNOCAINE (LIDOCAINE) Injection 1% POM (Pre- PP E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

675 P2584 LIGNOCAINE (LIDOCAINE) LIGNOCAINE (LIDOCAINE) Injection 4% POM (Pre- TA E 05.06.2012 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

676 P85 LIGNOCAINE (LIDOCAINE) LIGNOCAINE (LIDOCAINE) Topical Ointment 5% POM (Pre- PP E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 98 of 189 Authorized by:DG,MFDA
 677 P2836 LIGNOCAINE (LIDOCAINE) + LIGNOCAINE (LIDOCAINE) + Injection 2% Restricted for PP E 07.10.2017 - Product approved
ADRENALIN ADRENALIN Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

678 P2835 LIGNOCAINE (LIDOCAINE) + LIGNOCAINE (LIDOCAINE) + Injection for 2% + epinephrine 1:80 POM (Pre- PP E 07.10.2017 - Product approved
ADRENALIN ADRENALIN Dental cartridge 000 authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

679 P84 LIGNOCAINE (LIDOCAINE) + LIGNOCAINE (LIDOCAINE) + Injection 5% POM (Pre- PP E 07.10.2017 - Product approved
DEXTROSE DEXTROSE authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

680 P69 LIGNOCAINE (LIDOCAINE) + Lignocaine (lidocaine) + Topical Ointment 60mg + 5mg + 50mg + POM (Pre- PP E 07.10.2017 - Product approved
HYDROCORTISONE ACETATE + hydrocortisone acetate + 400mg in 1g authorization 31.07.2019 based on a
ALUMINIUM SUBACETATE + ZINC aluminium subacetate + zinc required before special request
-
OXIDE oxide( Xyloproct) import) from a clinician

681 P3959 LIGNOCAINE (LIDOCAINE) LIGNOCAINE (LIDOCAINE) Topical Solution 4% POM (Pre- PP 11.01.2017 - Product approved
HYDROCHLORIDE HYDROCHLORIDE authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

682 P70 LIGNOCAINE (LIDOCAINE)+ Lignocaine (lidocaine) + Suppository 60mg + 5mg + 50mg + POM (Pre- PP E 07.10.2017 - Product approved
HYDROCORTISONE ACETATE + hydrocortisone acetate + 400mg per suppository authorization 31.07.2019 based on a
ALUMINIUM SUBACETATE + ZINC aluminium subacetate + zinc required before special request
-
OXIDE oxide (Xylo proct) import) from a clinician

683 P3672 LINAGLIPTIN Linagliptin Tablet 5 mg POM (Pre- TA 23.02.2016 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 99 of 189 Authorized by:DG,MFDA
 684 P3883 LINAGLIPTIN + METFORMIN LINAGLIPTIN + METFORMIN Tablet 2.5mg+1000mg POM (Pre- TA 07.11.2016 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

685 P4212 LINAGLIPTIN + METFORMIN LINAGLIPTIN + METFORMIN - Tablet 2.5mg + 500mg POM (Pre- TA 13.03.2018 - Product approved
HYDROCHLORIDE HYDROCHLORIDE authorization 31.07.2019 based on a
required before special request
import) from a clinician

686 P3287 LIRAGLUTIDE Liraglutide Injection 6 mg /ml Restricted for TA 10.02.2015 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

687 P2590 LITHIUM Lithium Capsule 150 mg POM (Pre- TA 05.06.2012 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

688 P2591 LITHIUM Lithium Capsule 300 mg POM (Pre- TA 05.06.2012 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

689 P2592 LITHIUM Lithium Capsule 600 mg POM (Pre- TA 05.06.2012 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

690 P2588 LITHIUM Lithium Tablet 300 mg POM (Pre- TA 05.06.2012 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 100 of 189 Authorized by:DG,MFDA
 691 P2589 LITHIUM Lithium Tablet 450 mg POM (Pre- TA 05.06.2012 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

692 P2593 LITHIUM Lithium Oral Liquid 300 mg/5 ml POM (Pre- TA 05.06.2012 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

693 P4179 L-LEUCINE PH.EUR+ L- L-LEUCINE PH.EUR+ L- Solution for 1.30G+0.80G+1.20G+0.3 Restricted for TA 07.10.2017 - Product approved
ISOLEUCINE PH.EUR+L-LYSINE ISOLEUCINE PH.EUR+L- infusion (Infant 12G+0.375G+0.440G+0. Hospital use only (Pre- 31.07.2019 based on a
ACETATE USP+ L-LYSIN 0.851G+L- LYSINE ACETATE USP+ L- 10%) 201G+0.900G+0.750G+ Authorization Each special request
METHIONINE PH.EUR+ L- LYSIN 0.851G+L-METHIONINE 0.476G + 0.415G required before Shipment from a clinician
PHENYLALANINIE PH.EUR+ L- PH.EUR+ L-PHENYLALANINIE 0.040G+0.767G+0.930G import) should be
THREONINE PH.EUR+ L- PH.EUR+ L-THREONINE +0.971G+0.5176G+0.07 accompanied
TRYPTOPHAN PH.EUR+ L-VALINE PH.EUR+ L-TRYPTOPHAN 0G+0.262G (10%) by the batch
PH.EUR+ LARGININE PH.EUR+ L- PH.EUR+ L-VALINE PH.EUR+ certificates
HISTIDINE PH.EUR+ GLYCINE LARGININE PH.EUR+ L-
PH.EUR+ TAURINE +L-SERINE HISTIDINE PH.EUR+ GLYCINE
PH.EUR+ L-ALANINE PH.EUR+ L- PH.EUR+ TAURINE +L-SERINE
PROLINE PH.EUR+ N-ACETYL-L PH.EUR+ L-ALANINE PH.EUR+ -
TRYROSINE DAB 1997+ L- L-PROLINE PH.EUR+ N-
TRYOSINE 0.420G + N-ACETYL-L - ACETYL-L TRYROSINE DAB
CYSTEINE DAB 1997+ L-CYSTEINE 1997+ L-TRYOSINE 0.420G +
0.052G + L-MALIC ACI DAB 1997 N-ACETYL-L -CYSTEINE DAB
1997+ L-CYSTEINE 0.052G + L-
MALIC ACI DAB 1997
(Aminoven Infant 10%)

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 101 of 189 Authorized by:DG,MFDA
 694 P4305 L-LEUCINE+ L-ISOLEUCINE+ L- L-LEUCINE+ L-ISOLEUCINE+ L- Oral Liquid 18.3mg+ 5.9mg+ 25mg+ POM (Pre- TA 24.07.2018 - Product approved
LYSINE HCL+ L-PHENYLALANINE+ LYSINE HCL+ L- 5mg+ 4.2mg+ 9.2mg+ authorization 23.07.2019 based on a
L-THREONINE+ L-METHIONINE+ L- PHENYLALANINE+ L- 5mg+ 6.7mg+ 5mg+ required before special request
TRYPTOPHAN+ L-VALLINE + THREONINE+ L- 3mg+ 1.5mg+ 25mg+ import) from a clinician
THIAMINE HYDROCHLORIDE ( METHIONINE+ L- 5mg+ 2.5mg+ 0.75mg+
VITAMINB1)+ RIBOFLAVIN TRYPTOPHAN+ L-VALLINE + 40mg+ 2500IU+
(VITAMIN B2)+ PYRIDOXINE THIAMINE HYDROCHLORIDE ( 200IU+7.5IU / 15ml
HYDROCHLORIDE (VITAMIN B6)+ VITAMINB1)+ RIBOFLAVIN
NICOTAMIDE (VITAMIN B3)+ (VITAMIN B2)+ PYRIDOXINE
CALCIUM PANTOTHENATE HYDROCHLORIDE (VITAMIN
(VITAMIN B5)+ B6)+ NICOTAMIDE (VITAMIN
CYANOCOBALAMIN (VITAMIN B3)+ CALCIUM -
B12) + FOLIC ACID+ ASCORBIC PANTOTHENATE (VITAMIN
ACID (VITAMIN C) + SYNTHETIC B5)+ CYANOCOBALAMIN
RETINOL CONCENTRATE+ (VITAMIN B12) + FOLIC ACID+
COLECALCIFEROL ( VITAMIN D3)+ ASCORBIC ACID (VITAMIN C)
VITAMIN E + SYNTHETIC RETINOL
CONCENTRATE+
COLECALCIFEROL ( VITAMIN
D3)+ VITAMIN E

695 P399 Lopinavir/Ritonav Lopinavir/Ritonav Capsule 133.3mg+33.3mg Restricted and to be PP 07.10.2017 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

696 P401 Lopinavir/Ritonav Lopinavir/Ritonav Tablet 100mg+25mg Restricted and to be PP 07.10.2017 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

697 P402 Lopinavir/Ritonav Lopinavir/Ritonav Tablet 200mg+50 mg Restricted and to be PP 07.10.2017 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 102 of 189 Authorized by:DG,MFDA
 698 P400 Lopinavir/Ritonav Lopinavir/Ritonav Oral Liquid 400mg+100mg/5ml Restricted and to be PP 07.10.2017 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

699 P2947 LORAZEPAM LORAZEPAM injection 2mg/ml CONTROLLED ( Pre- PP E 20.05.2014 - Product approved
Authorization 31.07.2019 based on a
required before special request
-
import ) from a clinician

700 P3975 LUTROPIN ALPHA Lutropin alpha Injection 75IU/vial Restricted for TA 06.06.2017 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

701 P2564 LYNOESTRENOL LYNOESTRENOL Tablet 0.5 mg Restricted and to be PP 07.10.2017 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

702 P363 LYNOESTRENOL Lynestrenol Tablet 0.5mg Restricted and to be PP 07.10.2017 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

703 P4371 MAGNESIUM CARBONATE + MAGNESIUM CARBONATE + - Sterile aqueous 162.65mg + 59.65mg + Restricted for TA 23.10.2018 - Product approved
POTASSIUM CHLORIDE + POTASSIUM CHLORIDE + Solution for 13.64mg Hospital Use Only 22.10.2019 based on a
PROCAINE SOLUTION PROCAINE SOLUTION Infusion (Pre-authorization special request
required before from a clinician
import)

704 P3036 MANNITOL MANNITOL Injection 10% POM (Pre- PP E 20.05.2014 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 103 of 189 Authorized by:DG,MFDA
 705 P3059 Measles vaccine Measles vaccine Injection Restricted and to be PP E 20.05.2014 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

706 P442 MEBEVERINE MEBEVERINE Tablet 135 mg POM (Pre- PP 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

707 P4104 MECOBALAMINE Mecobalamine Tablet 500mcg POM (Pre- TA 05.12.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

708 P3047 MEDROXYPROGESTERONE MEDROXYPROGESTERONE Tablet 2.5 mg POM (Pre- PP E 20.05.2014 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

709 P1332 MEFENAMIC ACID MEFENAMIC ACID Oral Liquid 50 mg/5ml OTC (Pre- PP E 07.10.2017 - Product approved
Authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

710 P4220 MEFENAMIC ACID + MEFENAMIC ACID + - Tablet 250mg + 10mg POM (Pre- TA 13.03.2018 - Product approved
DICYCLOMINE HYDROCHLORIDE DICYCLOMINE authorization 31.07.2019 based on a
HYDROCHLORIDE required before special request
import) from a clinician

711 P347 MEFLOQUINE MEFLOQUINE Tablet 250 mg Restricted and to be PP 07.10.2017 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 104 of 189 Authorized by:DG,MFDA
 712 P4451 MEGESTROL MEGESTROL - Tablet 40mg POM (Pre- TA 09.04.2019 - Product approved
authorization 08.04.2020 based on a
required before special request
import) from a clinician

713 P2534 Meloxicam Meloxicam Tablet 15 mg POM (Pre- TA 20.09.2012 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

714 P3282 MEMANTINE Memantine Tablet 5 mg POM (Pre- TA 10.02.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

715 P3283 MEMANTINE Memantine Tablet 10 mg POM (Pre- TA 10.02.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

716 P4396 MENINGOCOCCAL MENINGITIS Menningococcal Meningitis - Vaccine 50mcg of purified Restricted and to be TA E 04.02.2019 - Product approved
VACCINE Vaccine polysaccaride of used for the National 05.02.2020 based on a
N.menigitidis group A program only (Pre- Essential
and C 0.5ml/ Authorization Medicine List
required before 2018
import)

717 P3696 MENOTROPINS Menotropins Injection 75 IU FSH + 75 IU LH Restricted for PP 03.05.2016 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

718 P1762 MEPHENTERMINE MEPHENTERMINE Injection 15 mg/ml in 1ml Restricted for PP 07.10.2017 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 105 of 189 Authorized by:DG,MFDA
 719 P1763 MEPHENTERMINE MEPHENTERMINE Injection 30 mg/ml in 10ml Restricted for PP 07.10.2017 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

720 P3290 MEPHENTERMINE Mephentermine Injection 30 mg/ml Restricted for TA 10.02.2015 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

721 P3289 MEPHENTERMINE Mephentermine Tablet 10 mg POM (Pre- TA 10.02.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

722 P2475 MEROPENEM MEROPENEM Injection 250 mg POM (Pre- TA 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

723 P3421 MESALAMINE Mesalamine Capsule (Delayed 800 mg POM (Pre- TA 24.03.2015 - Product approved
Release) authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

724 P3422 MESALAMINE Mesalamine Capsule (Delayed 1.2 g POM (Pre- TA 24.03.2015 - Product approved
Release) authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

725 P3423 MESALAMINE Mesalamine Capsule (Delayed 400 mg POM (Pre- TA 24.03.2015 - Product approved
Release) authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 106 of 189 Authorized by:DG,MFDA
 726 P3418 MESALAMINE Mesalamine Tablet 250 mg POM (Pre- TA 24.03.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

727 P3419 MESALAMINE Mesalamine Tablet 375 mg POM (Pre- TA 24.03.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

728 P3420 MESALAMINE Mesalamine Tablet 500 mg POM (Pre- TA 24.03.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

729 P4461 MESNA MESNA - Injection 100mg/ml (400mg/4ml Restricted for TA 09.04.2019 - Product approved
and 100mg/10ml) Hospital Use Only 08.04.2020 based on a
(Pre-authorization special request
required before from a clinician
import)

730 P3855 METFORMIN HCL Metformin HCL Tablet 250 mg POM (Pre- TA 01.11.2016 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

731 P3670 METFORMIN HCL + Metformin Hcl+ Pioglitazone Tablet 500 mg + 15 mg POM (Pre- TA 23.02.2016 - Product approved
PIOGLITAZONE HCL Hcl authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

732 P3078 METHADONE Methadone Oral Liquid 10mg/ml CONTROLLED PP E 20.05.2014 - Product approved
(Restricted and only 31.07.2019 based on a
for NDA) ( Pre- special request
-
Authorization from a clinician
required before
import )

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 107 of 189 Authorized by:DG,MFDA
 733 P3332 Methimazole Methimazole Tablet 5 mg POM (Pre- TA 10.02.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

734 P3333 Methimazole Methimazole Tablet 10 mg POM (Pre- TA 10.02.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

735 P134 METHOTREXATE METHOTREXATE Injection 50mg/2ml POM (Pre- TA 08.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

736 P133 METHOTREXATE METHOTREXATE Tablet 2.5 mg POM (Pre- PP 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

737 P2940 METHOTREXATE METHOTREXATE Tablet 5mg POM (Pre- PP E 20.05.2014 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

738 P2941 METHOTREXATE METHOTREXATE Tablet 7.5mg POM (Pre- PP E 20.05.2014 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

739 P2942 METHOTREXATE METHOTREXATE Tablet 10mg POM (Pre- PP E 20.05.2014 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 108 of 189 Authorized by:DG,MFDA
 740 P4306 METHOTREXATE METHOTREXATE Injection 20mg/ml Restricted for TA 24.07.2018 - Product approved
Hospital Use Only 23.07.2019 based on a
(Pre-authorization special request
-
required before from a clinician
import)

741 P4359 METHOTREXATE METHOTREXATE - Injection 500mg/vial Restricted for TA E 23.10.2018 - Product approved
Hospital Use Only 22.10.2019 based on a
(Pre-authorization special request
required before from a clinician
import)

742 P3929 METHOXY POLYETHYLENE GLYCO - METHOXY POLYETHYLENE Injection 50mcg /0.3ml Restricted for TA 07.11.2016 - Product approved
EPOETIN BETA GLYCO -EPOETIN BETA Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

743 P1153 METHYL NICOTINATE + 2- METHYL NICOTINATE + 2- Spray 1.6% w/w(BP)+ 5.0% OTC (Pre- PP 07.10.2017 - Product approved
HYDROXYETHYL SALICYLATE + HYDROXYETHYL SALICYLATE w/w+ 1.0% w/w(BP)+ Authorization 31.07.2019 based on a
METHYL SALICYLATE + ETHYL + METHYL SALICYLATE + 5.0% w/w and Propan-2- required before special request
-
SALICYLATE AND PROPAN-2-OL + ETHYL SALICYLATE AND ol+ Butane import) from a clinician
BUTANE PROPAN-2-OL + BUTANE

744 P3878 METHYLDOPA METHYLDOPA Tablet 500mg POM (Pre- TA 07.11.2016 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

745 P3863 METHYLENE BLUE METHYLENE BLUE Injection 10 mg/ml (in 5 ml) Restricted for TA 07.11.2016 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

746 P4317 METHYLPREDNISOLONE Methylprednisolone Injection 125mg/2ml Restricted for TA 02.10.2018 - Product approved
Hospital Use Only 01.10.2019 based on a
(Pre-authorization special request
-
required before from a clinician
import)

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 109 of 189 Authorized by:DG,MFDA
 747 P3371 METHYLPREDNISOLONE ACETATE Methylprednisolone Acetate Tablet 2 mg POM (Pre- TA 17.02.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

748 P3372 METHYLPREDNISOLONE ACETATE Methylprednisolone Acetate Tablet 8 mg POM (Pre- TA 17.02.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

749 P57 METOCLOPRAMIDE Metoclopramide Injection 5 mg / ml POM (Pre- PP E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

750 P3354 METOLAZONE Metolazone Tablet 2.5 mg POM (Pre- TA 17.02.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

751 P3355 METOLAZONE Metolazone Tablet 5 mg POM (Pre- TA 17.02.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

752 P3356 METOLAZONE Metolazone Tablet 10 mg POM (Pre- TA 17.02.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

753 P87 METOPROLOL Metoprolol Tablet 100 mg POM (Pre- PP E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 110 of 189 Authorized by:DG,MFDA
 754 P3364 METOPROLOL Metoprolol Tablet (XR) 50 mg POM (Pre- TA 17.02.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

755 P3363 METOPROLOL Metoprolol Tablet (XR) 25 mg POM (Pre- TA 17.02.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

756 P832 MICONAZOLE MICONAZOLE Ointment 2% IP POM (Pre- PP E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

757 P831 MICONAZOLE MICONAZOLE Cream 2% IP POM (Pre- PP E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

758 P2195 MICRONISED PROGESTERONE MICRONISED Capsule (Vaginal) 100mg POM (Pre- TA 07.10.2017 - Product approved
PROGESTERONE authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

759 P2194 MICRONISED PROGESTERONE MICRONISED Tablet 100 mg POM (Pre- TA 07.10.2017 - Product approved
PROGESTERONE authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

760 P3048 Micronised progesterone Micronised progesterone Tablet 25mg POM (Pre- PP E 20.05.2014 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 111 of 189 Authorized by:DG,MFDA
 761 P3049 Micronised progesterone Micronised progesterone Tablet 75mg POM (Pre- PP E 20.05.2014 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

762 P3218 MICRONISED PROGESTERONE MICRONISED Tablet 200 mg POM (Pre- TA 07.10.2017 - Product approved
PROGESTERONE authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

763 P1474 MIDAZOLAM MIDAZOLAM Injection 5mg/ml INTERNATIONALLY TA E 08.10.2017 - Product approved
CONTROLLED 31.07.2019 based on a
(PSYCHOTROPIC) ( Pre- special request
-
Authorization from a clinician
required before
import )
764 P4397 MIDAZOLAM Midazolam - Oral Liquid 2mg/ml INTERNATIONALLY TA E 04.02.2019 - Product approved
CONTROLLED 05.02.2020 based on a
(PSYCHOTROPIC) ( Pre- Essential
Authorization Medicine List
required before 2018
import )
765 P3072 Mifeprostone Mifeprostone Tablet 200mg Restricted for PP E 20.05.2014 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

766 P3325 MILRINONE LACTATE Milrinone Lactate Injection 200mcg/ml Restricted for TA 10.02.2015 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

767 P4372 MILRINONE LACTATE MILRINONE LACTATE - Injection 1mg/ml Restricted for TA 23.10.2018 - Product approved
Hospital Use Only 22.10.2019 based on a
(Pre-authorization special request
required before from a clinician
import)

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 112 of 189 Authorized by:DG,MFDA
 768 P3904 MINOXIDIL MINOXIDIL Tablet 5mg POM (Pre- TA 07.11.2016 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

769 P2612 MINOXIDIL + AMINEXIL Minoxidil + Aminexil Spray/Solution 2% w/v + 1.5 % w/v POM (Pre- TA 10.07.2012 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

770 P4446 MIRABEGRON MIRABEGRON - Prolonged release 50mg POM (Pre- TA 09.04.2019 - Product approved
tablet authorization 08.04.2020 based on a
required before special request
import) from a clinician

771 P4447 MIRABEGRON MIRABEGRON - Prolonged release 25mg POM (Pre- TA 09.04.2019 - Product approved
tablet authorization 08.04.2020 based on a
required before special request
import) from a clinician

772 P2549 MIRTAZAPINE MIRTAZAPINE Tablet 30 mg POM (Pre- PP 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

773 P2367 MISOPROSTOL MISOPROSTOL Tablet 100 mcg Restricted for EA 08.10.2017 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

774 P2930 MISOPROSTOL MISOPROSTOL - Tablet 25 mcg Restricted for TA 09.04.2019 - MTG/RE-MA/Fo
Hospital use only (Pre- 08.04.2020 0012/2019-0004
authorization
required before
import)

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 113 of 189 Authorized by:DG,MFDA
 775 P4422 MITOMYCIN MITOMYCIN Powder for 10mg/vial Restricted for TA 19.03.2019 - Product approved
solution for Hospital use only (Pre- 18.03.2020 based on a
injection authorization special request
-
required before from a clinician
import)

776 P2937 MORPHINE Morphine Injection 10 mg/ml CONTROLLED ( Pre- PP E 20.05.2014 - Product approved
Authorization 31.07.2019 based on a
required before special request
-
import ) from a clinician

777 P2939 MORPHINE Morphine Oral Liquid 10mg/5ml CONTROLLED ( Pre- PP E 20.05.2014 - Product approved
Authorization 31.07.2019 based on a
required before special request
-
import ) from a clinician

778 P2938 MORPHINE Morphine Tablet 30mg CONTROLLED ( Pre- PP E 20.05.2014 - Product approved
Authorization 31.07.2019 based on a
required before special request
-
import ) from a clinician

779 P3831 MORPHINE SULPHATE Morphine Sulphate Injection 5 mg/10 ml ( 0.5 mg/ml) CONTROLLED ( Pre- TA 01.11.2016 - Product approved
Authorization 31.07.2019 based on a
required before special request
-
import ) from a clinician

780 P3926 MOSAPRIDE MOSAPRIDE Tablet 5mg POM (Pre- TA 07.11.2016 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

781 P4308 MOXIFLOXACIN MOXIFLOXACIN Tablet 400mg POM (Pre- TA 24.07.2018 - Product approved
authorization 23.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 114 of 189 Authorized by:DG,MFDA
 782 P3876 MOXONIDINE MOXONIDINE Tablet 300mcg POM (Pre- TA 07.11.2016 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

783 P3877 MOXONIDINE MOXONIDINE Tablet 200mcg POM (Pre- TA 07.11.2016 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

784 P3413 MYCOPHENOLATE MOFETIL Mycophenolate Mofetil Injection 500 mg POM (Pre- TA 24.03.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

785 P3412 MYCOPHENOLATE MOFETIL Mycophenolate Mofetil Tablet 250 mg POM (Pre- TA 24.03.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

786 P3414 MYCOPHENOLATE MOFETIL Mycophenolate Mofetil Oral Liquid 200 mg/ml POM (Pre- TA 24.03.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

787 P3415 MYCOPHENOLATE MOFETIL Mycophenolate Mofetil Tablet (ER) 180 mg POM (Pre- TA 24.03.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

788 P3416 MYCOPHENOLATE MOFETIL Mycophenolate Mofetil Tablet (ER) 360 mg POM (Pre- TA 24.03.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 115 of 189 Authorized by:DG,MFDA
 789 P3641 N(2)- L-ALANYL-L GLUTAMINE N(2)- L-ALANYL-L Injections 20% Restricted for TA 19.01.2016 - Product approved
GLUTAMINE Hospital use only (Pre- 31.07.2019 based on a
Authorization Each special request
required before Shipment from a clinician
- import) should be
accompanied
by the batch
certificates

790 P3403 N-ACETYLCYSTEINE N-acetylcysteine Injection 20% Restricted for TA 24.03.2015 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

791 P3401 N-ACETYLCYSTEINE N-acetylcysteine Nebulising 10% POM (Pre- TA 24.03.2015 - Product approved
Solution authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

792 P3882 NAFTOPIDIL NAFTOPIDIL Tablet 50mg POM (Pre- TA 07.11.2016 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

793 P1640 NALOXONE HCL NALOXONE HCL Injection 400 mcg /1-ml amp CONTROLLED ( Pre- PP E 07.10.2017 - Product approved
Authorization 31.07.2019 based on a
required before special request
-
import ) from a clinician

794 P2362 NALTREXONE HYDROCHLORIDE NALTREXONE Tablet 50 mg CONTROLLED ( Pre- TA 07.10.2017 - Product approved
HYDROCHLORIDE Authorization 31.07.2019 based on a
required before special request
-
import ) from a clinician

795 P2361 NALTREXONE HYDROCHLORIDE NALTREXONE Tablet 25 mg CONTROLLED ( Pre- TA 07.10.2017 - Product approved
HYDROCHLORIDE Authorization 31.07.2019 based on a
required before special request
-
import ) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 116 of 189 Authorized by:DG,MFDA
 796 P4398 NATAMYCIN Natamycin - Eye Drops 0.3% Restricted for TA E 04.02.2019 - Product approved
Hospital Use Only 05.02.2020 based on a
(Pre-authorization Essential
required before Medicine List
import) 2018

797 P4318 N-BUTYL CYANOACRYLATE N-Butyl Cyanoacrylate Injection (Tissue 0.25ml Restricted for TA 02.10.2018 - Product approved
adhesives) Hospital Use Only 01.10.2019 based on a
(Pre-authorization special request
-
required before from a clinician
import)

798 P4319 N-BUTYL CYANOACRYLATE N-Butyl Cyanoacrylate Injection (Tissue 0.5ml Restricted for TA 02.10.2018 - Product approved
adhesives) Hospital Use Only 01.10.2019 based on a
(Pre-authorization special request
-
required before from a clinician
import)

799 P4320 N-BUTYL CYANOACRYLATE N-Butyl Cyanoacrylate Injection (Tissue 1ml Restricted for TA 02.10.2018 - Product approved
adhesives) Hospital Use Only 01.10.2019 based on a
(Pre-authorization special request
-
required before from a clinician
import)

800 P2985 Nelfinavir Nelfinavir Tablet 250mg Restricted and to be PP E 20.05.2014 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

801 P2984 Nelfinavir Nelfinavir Oral Liquid 50mg/g Restricted and to be PP E 20.05.2014 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

802 P1583 NEOSTIGMINE NEOSTIGMINE Injection 1.5mg/ml Restricted for PP 07.10.2017 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 117 of 189 Authorized by:DG,MFDA
 803 P3062 NEOSTIGMINE NEOSTIGMINE Injection 250 mcg /ml Restricted for PP E 20.05.2014 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

804 P1581 NEOSTIGMINE NEOSTIGMINE - Injection 0.5 mg /ml Restricted for TA 17.04.2018 - Product approved
Hospital Use Only 16.04.2019 based on a
(Pre-authorization special request
required before from a clinician
import)

805 P2618 Nevipramine Nevipramine Oral Liquid 10 mg/ml Restricted and to be TA 10.07.2012 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

806 P378 Nevirapine Nevirapine Tablet 50mg Restricted and to be PP 07.10.2017 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

807 P377 Nevirapine Nevirapine Tablet 200mg Restricted and to be PP 07.10.2017 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

808 P2983 Nevirapine Nevirapine Oral Liquid 50mg/ml Restricted for PP 20.05.2014 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

809 P4084 NICORANDIL Nicorandil Injection 2mg/vial Restricted for TA 31.10.2017 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 118 of 189 Authorized by:DG,MFDA
 810 P3343 NICORANDIL Nicorandil Tablet 5 mg POM (Pre- TA 17.02.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

811 P3344 NICORANDIL Nicorandil Tablet 10 mg POM (Pre- TA 17.02.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

812 P3345 NICORANDIL Nicorandil Tablet (SR) 20 mg POM (Pre- TA 17.02.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

813 P3960 NICORANDIL NICORANDIL Injection 48mg Restricted for TA 14.03.2017 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

814 P3790 NICOTINE Nicotine Pastilles 2mg POM (Pre- TA 11.10.2016 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

815 P3791 NICOTINE Nicotine Pastilles 4mg POM (Pre- TA 11.10.2016 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

816 P1302 NICOTINE PATCH Nicotine Patch Transdermal 5 mg POM (Pre- PP 07.10.2017 - Product approved
patch authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 119 of 189 Authorized by:DG,MFDA
 817 P3222 NICOTINE PATCH Nicotine Patch Transdermal 10 mg POM (Pre- PP 07.10.2017 - Product approved
patch authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

818 P3223 NICOTINE PATCH Nicotine Patch Transdermal 15 mg POM (Pre- PP 07.10.2017 - Product approved
patch authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

819 P3767 NICOTINE PATCH NICOTINE PATCH Transdermal 7 mg POM (Pre- TA 06.09.2016 - Product approved
Patch authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

820 P3769 NICOTINE PATCH NICOTINE PATCH Transdermal 21 mg POM (Pre- TA 06.09.2016 - Product approved
Patch authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

821 P3079 Nicotine replacement therapy Nicotine replacement chewing gum 2mg POM (Pre- PP E 20.05.2014 - Product approved
(NRT) therapy (NRT) authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

822 P3080 Nicotine replacement therapy Nicotine replacement Transdermal 5 to 30 mg/16 hrs and POM (Pre- PP E 20.05.2014 - Product approved
(NRT) therapy (NRT) patch 17 to 21mg/24 hrs authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

823 P3896 NICOUMALONE NICOUMALONE Tablet 4mg POM (Pre- TA 07.11.2016 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 120 of 189 Authorized by:DG,MFDA
 824 P58 NIFEDIPINE NIFEDIPINE Capsule(SR) 20mg POM (Pre- PP E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

825 P735 NITROFURANTOIN NITROFURANTOIN - Tablet 100mg POM (Pre- TA

authorization
required before
import)
826 P3873 NITROFURANTOIN NITROFURANTOIN Injection 25mg/5ml Restricted for TA 07.11.2016 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

827 P3907 NITROGLYCERINE NITROGLYCERINE Patch 0.5 mg POM (Pre- TA 07.11.2016 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

828 P4218 NITROGLYCERINE NITROGLYCERINE - Capsule 2.5mg POM (Pre- TA 13.03.2018 - Product approved
authorization 31.07.2019 based on a
required before special request
import) from a clinician

829 P1698 NITROUS OXIDE Nitrous Oxide Gas Cylinders Restricted for PP E 07.10.2017 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

830 P1308 NORETHINDRONE NORETHINDRONE Tablet 0.35mg POM (Pre- PP E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

831 P3188 NORMAL SALINE NORMAL SALINE Injection 3% Restricted for TA 06.11.2014 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 121 of 189 Authorized by:DG,MFDA
 832 P4079 NORTRIPTYLINE Nortriptyline Tablet 25mg POM (Pre- TA 31.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

833 P3910 NORTRIPTYLINE NORTRIPTYLINE Capsule 25mg POM (Pre- TA 07.11.2016 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

834 P3542 NYSTATIN Nystatin Eye Drops 0.2% POM (Pre- TA 30.06.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

835 P3293 OCTREOTIDE Octreotide Injection 0.05 mg /ml Restricted for TA 10.02.2015 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

836 P3294 OCTREOTIDE Octreotide Injection 0.1 mg / ml Restricted for TA 10.02.2015 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

837 P3295 OCTREOTIDE Octreotide Injection 0.2 mg /ml Restricted for TA 10.02.2015 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

838 P3296 OCTREOTIDE Octreotide Injection 0.5mg /ml Restricted for TA 10.02.2015 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 122 of 189 Authorized by:DG,MFDA
 839 P3297 OCTREOTIDE Octreotide Injection 1 mg/ ml Restricted for TA 10.02.2015 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

840 P3776 OCTREOTIDE ACETATE Octreotide Acetate Injectable 20mg POM (Pre- TA 11.10.2016 - Product approved
Suspension authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

841 P3777 OCTREOTIDE ACETATE Octreotide Acetate Injectable 30mg POM (Pre- TA 11.10.2016 - Product approved
Suspension authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

842 P3778 OCTREOTIDE ACETATE Octreotide Acetate Injectable 40mg POM (Pre- TA 11.10.2016 - Product approved
Suspension authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

843 P3091 Ofloxacin + Dexamethasone Ofloxacin + dexamethasone Ear/Eye Drops POM (Pre- PP E 20.05.2014 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

844 P3918 OFLOXACINE OFLOXACINE Injection 200mg Restricted for TA 07.11.2016 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

845 P3927 OFLOXACINE + TINIDAZOLE OFLOXACINE + TINIDAZOLE Tablet 200MG + 600MG POM (Pre- TA 07.11.2016 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 123 of 189 Authorized by:DG,MFDA
 846 P3245 OLANZAPINE Olanzapine Injection 5 mg CONTROLLED ( Pre- TA 20.01.2015 - Product approved
Authorization 31.07.2019 based on a
required before special request
-
import ) from a clinician

847 P3246 OLANZAPINE Olanzapine Injection 10 mg CONTROLLED ( Pre- TA 20.01.2015 - Product approved
Authorization 31.07.2019 based on a
required before special request
-
import ) from a clinician

848 P2095 OLANZAPINE Olanzapine Tablet 2.5 mg CONTROLLED ( Pre- PP 07.10.2017 - Product approved
Authorization 31.07.2019 based on a
required before special request
-
import ) from a clinician

849 P2097 OLANZAPINE Olanzapine Tablet 7.5 mg CONTROLLED ( Pre- PP 07.10.2017 - Product approved
Authorization 31.07.2019 based on a
required before special request
-
import ) from a clinician

850 P3247 OLANZAPINE Olanzapine Tablet 5mg CONTROLLED ( Pre- TA 20.01.2015 - Product approved
(Dispersible) Authorization 31.07.2019 based on a
required before special request
-
import ) from a clinician

851 P3248 OLANZAPINE Olanzapine Tablet 10 mg CONTROLLED TA 20.01.2015 - Product approved

(Dispersible) (Restricted and only 31.07.2019 based on a
for NDA) ( Pre- special request
-
Authorization from a clinician
required before
import )
852 P2096 OLANZAPINE Olanzapine Tablet 5 mg CONTROLLED ( Pre- PP 07.10.2017 - Product approved
Authorization 31.07.2019 based on a
required before special request
-
import ) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 124 of 189 Authorized by:DG,MFDA
 853 P2098 OLANZAPINE Olanzapine Tablet 10 mg CONTROLLED ( Pre- PP 07.10.2017 - Product approved
Authorization 31.07.2019 based on a
required before special request
-
import ) from a clinician

854 P3384 OMALIZUMAB Omalizumab Injection 125mg/ml Restricted for TA 17.02.2015 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

855 P3409 OMALIZUMAB Omalizumab Injection 150mg /1.2ml Restricted for TA 24.03.2015 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

856 P3644 OMEGA 3 FATTY ACID OMEGA 3 FATTY ACID Injections 10% Restricted for TA 19.01.2016 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization Each special request
required before Shipment from a clinician
- import) should be
accompanied
by the batch
certificates

857 P2996 ONDANSETRON ONDANSETRON injection 4mg/ml POM (Pre- PP E 20.05.2014 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

858 P2997 ONDANSETRON ONDANSETRON injection 8mg/ml POM (Pre- PP E 20.05.2014 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

859 P451 ORAL REHYDRATION SALT Oral Rehydration Salt (WHO Powder for Oral OTC (Pre- PP E 07.10.2017 - Product approved
Recommended Brands) Solution Authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 125 of 189 Authorized by:DG,MFDA
 860 P4399 OSELTAMIVIR Oseltamivir - Capsule 30mg POM (Pre- TA E 04.02.2019 - Product approved
authorization 05.02.2020 based on a
required before Essential
import) Medicine List
2018

861 P4400 OSELTAMIVIR Oseltamivir - Capsule 45mg POM (Pre- TA E 04.02.2019 - Product approved
authorization 05.02.2020 based on a
required before Essential
import) Medicine List
2018

862 P4401 OSELTAMIVIR Oseltamivir - Capsule 75mg POM (Pre- TA E 04.02.2019 - Product approved
authorization 05.02.2020 based on a
required before Essential
import) Medicine List
2018

863 P4402 OSELTAMIVIR Oseltamivir - Oral Liquid 12mg/ml POM (Pre- TA E 04.02.2019 - Product approved
authorization 05.02.2020 based on a
required before Essential
import) Medicine List
2018

864 P4087 OXALIPLATIN Oxaliplatin Injection 50mg Restricted for TA 05.12.2017 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

865 P4203 OXALIPLATIN Oxaliplatin Injection 100mg Restricted for TA 05.12.2017 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

866 P1699 OXYBUTYNIN HCL Oxybutynin Tablet 2.5mg POM (Pre- PP E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 126 of 189 Authorized by:DG,MFDA
 867 P3225 OXYBUTYNIN HCL Oxybutynin Tablet 3 mg POM (Pre- PP E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

868 P3226 OXYBUTYNIN HCL Oxybutynin Tablet 5 mg POM (Pre- PP E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

869 P2454 OXYGEN Oxygen Gas Cylinders POM (Pre- PP E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

870 P1272 OXYTOCIN OXYTOCIN Injection 5 IU/ml Restricted for EA E 08.10.2017 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

871 P3071 OXYTOCIN OXYTOCIN Injection 10 IU/ml Restricted for PP E 20.05.2014 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

872 P4237 PACLITAXEL PACLITAXEL - Injection 6mg/ml Restricted for TA 10.04.2018 - Product approved
(30mg/5ml, Hospital use only (Pre- 31.07.2019 based on a
100mg/16.7ml) authorization special request
required before from a clinician
import)

873 P4238 PACLITAXEL PACLITAXEL - Injection 6mg/ml Restricted for TA 10.04.2018 - Product approved
(150mg/25ml, Hospital use only (Pre- 31.07.2019 based on a
260mg/43.3ml, authorization special request
300mg/50ml) required before from a clinician
import)

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 127 of 189 Authorized by:DG,MFDA
 874 P4452 PALBOCICLIB PALBOCICLIB - Capsule 125mg POM (Pre- TA 09.04.2019 - Product approved
authorization 08.04.2020 based on a
required before special request
import) from a clinician

875 P4303 PALONOSETRON PALONOSETRON Injection 0.25mg Restricted for TA 24.07.2018 - Product approved
HYDROCHLORIDE HYDROCHLORIDE Hospital Use Only 23.07.2019 based on a
(Pre-authorization special request
-
required before from a clinician
import)

876 P911 PANCURONIUM PANCURONIUM Injection 4 mg /2 ml Restricted for EA E 08.10.2017 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

877 P3886 PAPAVERINE HYDROCHLORIDE PAPAVERINE Injection 30 mg/ml Restricted for TA 07.11.2016 - Product approved
HYDROCHLORIDE Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

878 P3832 PARACETAMOL Paracetamol Suppositories 80 mg POM (Pre- TA 01.11.2016 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

879 P3847 PARACETAMOL Paracetamol Suppositoriy 170 mg POM (Pre- TA 01.11.2016 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

880 P1584 PARACETAMOL PARACETAMOL Injection 150 mg/ml POM (Pre- PP E 07.10.2017 - Circular # 182-
authorization 31.07.2019 MTG/CIRC/2018/
-
required before 02
import)
881 P1981 PARACETAMOL PARACETAMOL Suppository 125 mg OTC (Pre- TA E 13.03.12 - Product approved
(Acetaminophen) Authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 128 of 189 Authorized by:DG,MFDA
 882 P1983 PARACETAMOL PARACETAMOL Suppository 500 mg OTC (Pre- TA E 13.03.14 - Product approved
(Acetaminophen) Authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

883 P1982 PARACETAMOL PARACETAMOL - Suppository 250mg OTC (Pre- TA E 08.10.2017 -

Authorization 31.07.2019
required before
import)
884 P4239 PARACETAMOL + PARACETAMOL + - Tablet 300mg + 150mg +50mg POM (Pre- TA 10.04.2018 - Product approved
PROPYPHENAZONE + PROPYPHENAZONE + authorization 31.07.2019 based on a
ANHYDROUS CAFFEINE ANHYDROUS CAFFEINE required before special request
import) from a clinician

885 P3239 PAROXETINE HYDROCHLORIDE Paroxetine Hydrochloride Tablet 10 mg POM (Pre- TA 20.01.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

886 P3240 PAROXETINE HYDROCHLORIDE Paroxetine Hydrochloride Tablet 20 mg POM (Pre- TA 20.01.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

887 P1445 PEFLOXACIN PEFLOXACIN Tablet 400 mg POM (Pre- PP 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

888 P4209 PEGFILGRASTIM PEGFILGRASTIM - Injection 6mg Restricted for TA 13.03.2018 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
authorization special request
required before from a clinician
import)

889 P4233 PEMETREXED PEMETREXED - Injection 100mg/vial Restricted for TA 10.04.2018 - Product approved
Hospital Use Only 31.07.2019 based on a
(Pre-authorization special request
required before from a clinician
import)

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 129 of 189 Authorized by:DG,MFDA
 890 P4234 PEMETREXED PEMETREXED - Injection 500mg/vial Restricted for TA 10.04.2018 - Product approved
Hospital Use Only 31.07.2019 based on a
(Pre-authorization special request
required before from a clinician
import)

891 P1777 PENICILLIN BENZATHINE PENICILLIN BENZATHINE Injection 1200000 units POM (Pre- PP E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

892 P60 PENICILLIN BENZYL PENICILLIN BENZYL Injection 100000 iu/5ml POM (Pre- PP E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

893 P2917 PENICILLIN G POTASSIUM PENICILLIN G POTASSIUM Tablet 400 mg POM (Pre- TA 18.03.2014 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

894 P61 PENICILLIN G PROCAINE PENICILLIN G PROCAINE Injection 100000iu/ml , POM (Pre- PP E 07.10.2017 - Product approved
300000iuml authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

895 P1796 PENICILLIN V PENICILLIN V Tablet 400 mg POM (Pre- PP E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

896 P1797 PENICILLIN V PENICILLIN V Tablet 800 mg POM (Pre- PP E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 130 of 189 Authorized by:DG,MFDA
 897 P4403 PENICILLIN V Penicillin V - Oral Liquid 125mg/5ml POM (Pre- TA E 04.02.2019 - Product approved
authorization 05.02.2020 based on a
required before Essential
import) Medicine List
2018

898 P3928 PENTASAN POLYSULFATE PENTASAN POLYSULFATE Capsule 100MG POM (Pre- TA 07.11.2016 - Product approved
SODIUM SODIUM authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

899 P373 Pentavalent vaccine (Diphtheria, Pentavalent vaccine Injection Pentavalent Restricted and to be PP 07.10.2017 - Product approved
pertisis,hepatitis B, Hemophilus (Diphtheria, pertisis,hepatitis used for the National 31.07.2019 based on a
influenza B) B, Hemophilus influenza B) program only (Pre- special request
- Authorization from a clinician
required before
import)

900 P3861 PERITONEAL DIALYSIS PERITONEAL DIALYSIS Solution 2.5% L ( 5000ml) Restricted for TA 07.11.2016 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

901 P4325 PERITONEAL DIALYSIS SOLUTION: PERITONEAL DIALYSIS Solution 1.5 g + 538mg + 448mg Restricted for TA 02.10.2018 - Product approved
DEXTROSE HYDROUS USP, SOLUTION: DEXTROSE + 25.7mg + 5.08mg Hospital Use Only 01.10.2019 based on a
SODIUM CHLORIDE USP (NACL), HYDROUS USP, SODIUM (1.5% Dextrose 2000ml (Pre-authorization special request
SODIUM LACTATE (C3H5NaO3 ), CHLORIDE USP (NACL), solution) required before from a clinician
CALCIUM CHLORIDE USP (CaCl2 SODIUM LACTATE import)
-
•2H2O), MAGNESIUM CHLORIDE (C3H5NAO3 ), CALCIUM
USP (MgCl2 •6H2O) CHLORIDE USP (CACL2
•2H2O), MAGNESIUM
CHLORIDE USP (MGCL2
•6H2O)
902 P1700 PERMETHRIN permethrin Cream 5% OTC (Pre- PP 07.10.2017 - Product approved
Authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 131 of 189 Authorized by:DG,MFDA
 903 P3781 PHENTERMINE + TOPIRAMATE Phentermine + Topiramate Capsule 3.75mg+23mg POM (Pre- TA 11.10.2016 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

904 P3782 PHENTERMINE + TOPIRAMATE Phentermine + Topiramate Capsule 7.5mg+46mg POM (Pre- TA 11.10.2016 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

905 P3783 PHENTERMINE + TOPIRAMATE Phentermine + Topiramate Capsule 11.25mg+69mg POM (Pre- TA 11.10.2016 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

906 P3784 PHENTERMINE + TOPIRAMATE Phentermine + Topiramate Capsule 15mg+92mg POM (Pre- TA 11.10.2016 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

907 P3173 PHENYEPHRINE PHENYLEPHRINE Injection 10mg/ml Restricted for TA 16.09.2014 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

908 P3070 PHENYLEPHRINE PHENYLEPHRINE Eye Drops 0.12% POM (Pre- TA E 20.05.2014 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

909 P539 PHENYLEPHRINE PHENYLEPHRINE ENT Solution 10% POM (Pre- TA 27.08.2019 - 26.08.2020
authorization
-
required before
import)
910 P3392 PHENYLEPHRINE + Phenylephrine+ Oral Liquid 5mg+2mg/5ml POM (Pre- TA 17.02.2015 - Product approved
CHLORPHENIRAMINE MALEATE Chlorpheniramine Maleate authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 132 of 189 Authorized by:DG,MFDA
 911 P979 PHENYTOIN SODIUM PHENYTOIN SODIUM Tablet 100 mg POM (Pre- PP E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

912 P2951 PHENYTOIN SODIUM PHENYTOIN SODIUM Injection 50mg/ml POM (Pre- PP E 20.05.2014 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

913 P2948 PHENYTOIN SODIUM PHENYTOIN SODIUM Tablet 50 mg POM (Pre- PP E 20.05.2014 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

914 P2949 PHENYTOIN SODIUM PHENYTOIN SODIUM Tablet 25 mg POM (Pre- PP E 20.05.2014 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

915 P2950 PHENYTOIN SODIUM PHENYTOIN SODIUM Oral Liquid 25 to 30mg/ml POM (Pre- PP E 20.05.2014 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

916 P3004 Phytomenadione Phytomenadione Injection 10mg/ml POM (Pre- PP E 20.05.2014 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

917 P3005 Phytomenadione Phytomenadione Tablet 10mg POM (Pre- PP E 20.05.2014 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 133 of 189 Authorized by:DG,MFDA
 918 P4405 PILOCARPINE NITRATE Pilocarpine Nitrate - Injection 0.5% Restricted for TA E 04.02.2019 - Product approved
Hospital Use Only 05.02.2020 based on a
(Pre-authorization Essential
required before Medicine List
import) 2018

919 P3242 PIMOZIDE Pimozide Tablet 2 mg Restricted for TA 20.01.2015 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

920 P3824 PIPERACILLIN + TAZOBACTAM Piperacillin + Tazobactam Injection 1000 mg+ 125 mg Restricted for TA 01.11.2016 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

921 P4423 PIRFENIDONE PIRFENIDONE Tablet 200mg POM (Pre- TA 19.03.2019 - Product approved
authorization 18.03.2020 based on a
required before special request
-
import) from a clinician

922 P4424 PIRFENIDONE PIRFENIDONE Hard Capsule 267mg POM (Pre- TA 19.03.2019 - Product approved
authorization 18.03.2020 based on a
required before special request
-
import) from a clinician

923 P1193 POLIDOCANOL POLIDOCANOL Injection 3% Restricted for PP E 07.10.2017 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

924 P4406 POLIO VACCINE - ORAL (m OPV) POLIO VACCINE - ORAL (m - Vaccine - Restricted and to be TA E 04.02.2019 - Product approved
OPV) used for the National 05.02.2020 based on a
program only (Pre- Essential
Authorization Medicine List
required before 2018
import)

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 134 of 189 Authorized by:DG,MFDA
 925 P3060 Polio vaccine- Oral (OPV) Polio vaccine- Oral ( OPV) Injection Restricted and to be PP E 20.05.2014 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

926 P3061 Polio vaccine-Inactivated (IPV) Polio vaccine-Inactivated Injection Restricted for PP E 20.05.2014 - Product approved
(IPV) Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

927 P3893 POLYETHYLENE GLYCOL + POLYETHYLENE GLYCOL + Powder 17g POM (Pre- TA 07.11.2016 - Product approved
ELECTROLYTES ELECTROLYTES authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

928 P898 POLYGELINE (GELATIN POLYGELINE Injection 3.5g + 145mmol + Restricted for PP E 07.10.2017 - Product approved
POLYMER+ SODIUM + 5.1mmol + 6.25mmol+ Hospital use only (Pre- 31.07.2019 based on a
POTASSIUM + CALCIUM + 145mmol /100ml Authorization special request
-
CHLORIDE) required before from a clinician
import)

929 P43 POLYVINYL ALCOHOL POLYVINYL ALCOHOL Eye Drops 15ml POM (Pre- PP 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

930 P4081 POTASSIUM CHLORIDE Potassium Chloride Syrup 1.5mg/5ml POM (Pre- TA E 31.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

931 P2924 POTASSIUM CHLORIDE POTASSIUM CHLORIDE Injection 150 mg Restricted for EA E 08.10.2017 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 135 of 189 Authorized by:DG,MFDA
 932 P1299 POTASSIUM CHLORIDE POTASSIUM CHLORIDE (Slow - Tablet (SR) 600 mg POM (Pre- PP E 07.10.2017 - Product approved
K) authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

933 P4302 POTASSIUM CHLORIDE + SODIUM POTASSIUM CHLORIDE + Power (oral 1.484g + 3.37g + 118g + Restricted for TA 24.07.2018 - Product approved
BICARBONATE + POLYETHYLENE SODIUM BICARBONATE + solution) 2.93g + 11.36g/137.15g Hospital Use Only 23.07.2019 based on a
GLYCOL + SODIUM CHLORIDE + POLYETHYLENE GLYCOL + (Pre-authorization special request
-
SODIUM SULPHATE SODIUM CHLORIDE + required before from a clinician
SODIUM SULPHATE import)

934 P3912 POTASSIUM CITRATE POTASSIUM CITRATE Tablet 10 mEq (1080mg) POM (Pre- TA 07.11.2016 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

935 P3930 POTASSIUM CITRATE POTASSIUM CITRATE Tablet 714.9mg + 263.1mg + POM (Pre- TA 07.11.2016 - Product approved
+MAGNESIUM CITRATE + +MAGNESIUM CITRATE + 15mg authorization 31.07.2019 based on a
PYRIDOXINE PYRIDOXINE required before special request
-
import) from a clinician

936 P2981 Potassium iodide Potassium iodide Saturated POM (Pre- PP E 20.05.2014 - Product approved
solution authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

937 P3925 POTASSIUM MAGNESIUM POTASSIUM MAGNESIUM Capsule 978mg POM (Pre- TA 07.11.2016 - Product approved
CITRATE CITRATE authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

938 P3026 Potassium permanganate Potassium permanganate Crystals, powder POM (Pre- PP E 20.05.2014 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 136 of 189 Authorized by:DG,MFDA
 939 P4247 POTASSUM CITRATE + CITRIC POTASSUM CITRATE + CITRIC - Syrup 1100mg + 334mg / 5ml POM (Pre- TA 10.04.2018 - Product approved
ACID ACID authorization 31.07.2019 based on a
required before special request
import) from a clinician

940 P1739 POVIDONE IODINE POVIDONE IODINE Topical Ointment 5% IP OTC (Pre- PP E 07.10.2017 - Product approved
Authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

941 P1705 PRALIDOXIME PRALIDOXIME Injection 1g/vial, with 20ml Restricted for PP E 07.10.2017 - Product approved
diluent Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

942 P2916 PRASUGREL PRASUGREL Tablet 10 mg POM (Pre- TA 18.03.2014 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

943 P1338 PRAZOSIN HYDROCHLORIDE PRAZOSIN HYDROCHLORIDE Tablet 2.5 mg POM (Pre- EA 08.10.2017 -
authorization 31.07.2019
-
required before
import)
944 P1339 PRAZOSIN HYDROCHLORIDE PRAZOSIN HYDROCHLORIDE Tablet 5 mg POM (Pre- EA 08.10.2017 -
authorization 31.07.2019
-
required before
import)
945 P3888 PREDNISOLONE PREDNISOLONE Tablet 40mg POM (Pre- TA 07.11.2016 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

946 P3889 PREDNISOLONE PREDNISOLONE Tablet 2.5mg POM (Pre- TA 07.11.2016 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 137 of 189 Authorized by:DG,MFDA
 947 P3890 PREDNISOLONE PREDNISOLONE Syrup 15mg/5ml POM (Pre- TA 07.11.2016 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

948 P4080 PREGABALIN + MECOBALAMIN Pregabalin + Mecobalamin Capsule 75mg + 750mcg POM (Pre- TA 31.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

949 P3288 PREMIXED INSULIN Premixed Insulin Injection 50mg /50mg POM (Pre- TA 10.02.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

950 P346 PRIMAQUINE PRIMAQUINE Tablet 7.5 mg Restricted and to be PP 07.10.2017 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

951 P345 PRIMAQUINE PRIMAQUINE Tablet 15mg Restricted and to be PP 07.10.2017 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

952 P4407 PROCAINE BENZYLPENICILLIN Procaine Benzylpenicillin - Injection 1.2 million IU Restricted for TA E 04.02.2019 - Product approved
Hospital Use Only 05.02.2020 based on a
(Pre-authorization Essential
required before Medicine List
import) 2018

953 P4454 PROCARBAZINE PROCARBAZINE - Capsule 50mg POM (Pre- TA 09.04.2019 - Product approved
authorization 08.04.2020 based on a
required before special request
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 138 of 189 Authorized by:DG,MFDA
 954 P3964 PROGESTERONE Progesterone Injection 25mg/ml Restricted for TA 30.05.2017 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

955 P348 PROGUANIL PROGUANIL Tablet 100 mg Restricted and to be PP 07.10.2017 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

956 P1447 PROMETHAZINE PROMETHAZINE Tablet 10 mg OTC (Pre- PP E 07.10.2017 - Product approved
Authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

957 P1439 PROMETHAZINE HCL + PROMETHAZINE HCL + Oral Liquid 1.5mg(BP) + 1.5mg + POM (Pre- PP 07.10.2017 - Product approved
PHOLCODEINE + ALCOHOL PHOLCODEINE + ALCOHOL 3.8% v/v in 5ml authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

958 P3541 PROPACAINE Propacaine Eye Drops 0.5% POM (Pre- TA 30.06.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

959 P906 PROPRANOLOL PROPRANOLOL Injection 1mg/ml Restricted for PP E 07.10.2017 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

960 P2988 PROPRANOLOL Propranolol Tablet 5mg POM (Pre- PP E 20.05.2014 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 139 of 189 Authorized by:DG,MFDA
 961 P4230 PROPRANOLOL HYDROCHLORIDE PROPRANOLOL - Tablet 10mg POM (Pre- TA 10.04.2018 - Product approved
HYDROCHLORIDE authorization 31.07.2019 based on a
required before special request
import) from a clinician

962 P907 PROPRANOLOL HYDROCHLORIDE PROPRANOLOL - Tablet 40 mg POM (Pre- TA E

HYDROCHLORIDE authorization
required before
import)
963 P3052 Propylthiouracil Propylthiouracil Tablet 50 mg POM (Pre- PP E 20.05.2014 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

964 P3095 Prostoglandins E Prostoglandins E Injection prostoglandin E1 Restricted for PP E 20.05.2014 - Product approved
0.5mg/ml in Hospital use only (Pre- 31.07.2019 based on a
alcohol,prostoglandin Authorization special request
-
E2 1mg/ml required before from a clinician
import)

965 P1513 PROTAMINE SULFATE PROTAMINE SULFATE Injection 50mg POM (Pre- PP E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

966 P697 Pseudoephedrine + guaphenesin Pseudoephedrine + Oral Liquid CONTROLLED ( Pre- PP E 07.10.2017 - Product approved
guaphenesin Authorization 31.07.2019 based on a
required before special request
-
import ) from a clinician

967 P1358 PYRANTEL PAMOATE PYRANTEL PAMOATE Oral Liquid 125mg/ml OTC (Pre- PP 07.10.2017 - Product approved
Authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 140 of 189 Authorized by:DG,MFDA
 968 P334 PYRAZINAMIDE PYRAZINAMIDE Tablet 500 mg Restricted and to be PP E 07.10.2017 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

969 P335 PYRAZINAMIDE PYRAZINAMIDE Tablet 750 mg Restricted and to be PP E 07.10.2017 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

970 P336 PYRAZINAMIDE PYRAZINAMIDE Tablet 400 mg Restricted and to be PP E 07.10.2017 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

971 P2966 PYRAZINAMIDE PYRAZINAMIDE Tablet 1000 mg Restricted and to be PP E 20.05.2014 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

972 P3063 Pyridostigmine Pyridostigmine Injection 1mg/ml Restricted for PP E 20.05.2014 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

973 P3064 Pyridostigmine Pyridostigmine Tablet 60mg POM (Pre- PP E 20.05.2014 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

974 P3087 Pyridoxine Pyridoxine Tablet 25 mg POM (Pre- PP E 20.05.2014 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 141 of 189 Authorized by:DG,MFDA
 975 P3630 PYRIDOXINE Pyridoxine Tablet 25 mg POM (Pre- TA E 02.02.2016 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

976 P492 PYRIDOXINE HYDROCHLORIDE IP PYRIDOXINE - Sustained 100 mg POM (Pre- TA

HYDROCHLORIDE IP released Tablet authorization
required before
import)
977 P2987 PYRIMETHAMINE Pyrimethamine Tablet 25 mg POM (Pre- PP E 20.05.2014 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

978 P3277 QUETIAPINE Quetiapine Tablet 100 mg POM (Pre- TA 10.02.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

979 P3278 QUETIAPINE Quetiapine Tablet 300 mg POM (Pre- TA 10.02.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

980 P4076 QUETIAPINE Quetiapine Tablet 25mg POM (Pre- TA 31.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

981 P4204 QUETIAPINE QUETIAPINE - Tablet 50mg POM (Pre- TA 13.03.2018 - Product approved
authorization 31.07.2019 based on a
required before special request
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 142 of 189 Authorized by:DG,MFDA
 982 P4408 QUININE Quinine - Tablet 300mg Restricted and to be TA E 04.02.2019 - Product approved
used for the National 05.02.2020 based on a
program only (Pre- Essential
Authorization Medicine List
required before 2018
import)

983 P4409 QUININE Quinine - Tablet 100mg Restricted and to be TA E 04.02.2019 - Product approved
used for the National 05.02.2020 based on a
program only (Pre- Essential
Authorization Medicine List
required before 2018
import)

984 P4410 QUININE Quinine - Oral Liquid 150mg/ml Restricted and to be TA E 04.02.2019 - Product approved
used for the National 05.02.2020 based on a
program only (Pre- Essential
Authorization Medicine List
required before 2018
import)

985 P349 QUININE DIHYDROCHLORIDE QUININE DIHYDROCHLORIDE Injection 600mg/3ml Restricted and to be PP 07.10.2017 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

986 P350 QUININE DIHYDROCHLORIDE QUININE DIHYDROCHLORIDE Injection 80 mg/ml Restricted and to be PP 07.10.2017 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

987 P3885 RAMOSETRON RAMOSETRON Injection 0.3 mg ( in 2 ml) Restricted for TA 07.11.2016 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 143 of 189 Authorized by:DG,MFDA
 988 P3037 RANITIDINE RANITIDINE Oral Liquid 75mg/5ml POM (Pre- PP E 20.05.2014 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

989 P3369 RASBURICASE Rasburicase Injection 1.5 mg Restricted for TA 17.02.2015 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

990 P3370 RASBURICASE Rasburicase Injection 7.5 mg Restricted for TA 17.02.2015 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

991 P3234 REBOXETINE Reboxetine Tablet 2 mg POM (Pre- TA 20.01.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

992 P3235 REBOXETINE Reboxetine Tablet 4 mg POM (Pre- TA 20.01.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

993 P3486 RECOMBINANT GROWTH Recombinant Growth Injection 5 mg Restricted for TA 10.02.2015 - Product approved
HORMONE Hormone Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

994 P3487 RECOMBINANT GROWTH Recombinant Growth Injection 6 mg Restricted for TA 10.02.2015 - Product approved
HORMONE Hormone Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 144 of 189 Authorized by:DG,MFDA
 995 P3488 RECOMBINANT GROWTH Recombinant Growth Injection 12 mg Restricted for TA 10.02.2015 - Product approved
HORMONE Hormone Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

996 P3864 RECOMBINANT HUMAN RECOMBINANT HUMAN Injection 10,000 iu Restricted for TA 07.11.2016 - Product approved
ERYTHROPOIETIN ALPHA ERYTHROPOIETIN ALPHA Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

997 P3329 REPAGLINIDE Repaglinide Tablet 0.5 mg POM (Pre- TA 10.02.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

998 P3330 REPAGLINIDE Repaglinide Tablet 1 mg POM (Pre- TA 10.02.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

999 P3331 REPAGLINIDE Repaglinide Tablet 2 mg POM (Pre- TA 10.02.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1000 P2091 RESPERIDON RESPERIDON Tablet 1 mg POM (Pre- PP 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1001 P2092 RESPERIDON RESPERIDON Tablet 2mg POM (Pre- PP 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 145 of 189 Authorized by:DG,MFDA
 1002 P2093 RESPERIDON RESPERIDON Tablet 3 mg POM (Pre- PP 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1003 P2094 RESPERIDON RESPERIDON Tablet 4 mg POM (Pre- PP 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1004 P3089 Retinol Retinol Capsule 200 000 IU (as POM (Pre- PP E 20.05.2014 - Product approved
palmitate) (110 mg) authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1005 P3088 Retinol Retinol Tablet 10 000 IU (as POM (Pre- PP E 20.05.2014 - Product approved
palmitate) (5.5 mg) authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1006 P3340 RIBAVIRIN Ribavirin Capsule 400 mg POM (Pre- TA 10.02.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1007 P3339 RIBAVIRIN Ribavirin Tablet 200 mg POM (Pre- TA 10.02.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1008 P3342 RIBAVIRIN Ribavirin Aerosol 6g POM (Pre- TA 17.02.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 146 of 189 Authorized by:DG,MFDA
 1009 P3341 RIBAVIRIN Ribavirin Oral Liquid 40mg/ml POM (Pre- TA 10.02.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1010 P338 RIFAMPICIN RIFAMPICIN Capsule 300 mg Restricted and to be PP E 07.10.2017 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

1011 P339 RIFAMPICIN RIFAMPICIN Oral Liquid 100mg/5ml Restricted and to be PP E 07.10.2017 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

1012 P2967 RIFAMPICIN RIFAMPICIN Oral Liquid 200mg/5ml Restricted and to be PP E 20.05.2014 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

1013 P3875 RIFAMPICIN RIFAMPICIN Capsule 450mg Restricted and to be TA 07.11.2016 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

1014 P3880 RIFAMPICIN RIFAMPICIN Capsule 600mg Restricted and to be TA 07.11.2016 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 147 of 189 Authorized by:DG,MFDA
 1015 P337 RIFAMPICIN RIFAMPICIN Capsule 150 mg Restricted and to be PP E 07.10.2017 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

1016 P4411 RIFAMPICIN + ISONIAZID Rifampicin + Isoniazid - Tablet 300mg + 150mg Restricted and to be TA E 04.02.2019 - Product approved
used for the National 05.02.2020 based on a
program only (Pre- Essential
Authorization Medicine List
required before 2018
import)

1017 P4412 RIFAMPICIN + ISONIAZID Rifampicin + Isoniazid - Tablet 75mg + 50mg Restricted and to be TA E 04.02.2019 - Product approved
used for the National 05.02.2020 based on a
program only (Pre- Essential
Authorization Medicine List
required before 2018
import)

1018 P4413 RIFAMPICIN + ISONIAZID Rifampicin + Isoniazid - Tablet 60mg + 60mg Restricted and to be TA E 04.02.2019 - Product approved
used for the National 05.02.2020 based on a
program only (Pre- Essential
Authorization Medicine List
required before 2018
import)

1019 P2971 Rifampicin + Isoniazid Rifampicin + Isoniazid Combination Rifampicin 150 mg + Restricted and to be PP E 20.05.2014 - Product approved
Tablets Isoniazid 150mg used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

1020 P2968 Rifampicin + Isoniazid Rifampicin + Isoniazid Combination Rifampicin 60mg + Restricted and to be PP E 20.05.2014 - Product approved
Tablets Isoniazid 30 mg used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 148 of 189 Authorized by:DG,MFDA
 1021 P2972 Rifampicin + isoniazid + Rifampicin + isoniazid + Tablet 150mg +75mg +275 mg Restricted and to be PP E 20.05.2014 - Product approved
ethambutol ethambutol used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

1022 P4086 RIFAMPICIN + ISONIAZID + Rifampicin + Isoniazid + Tablet 75mg + 50mg + 150mg Restricted and to be TA 31.10.2017 - Product approved
PYRAZINAMIDE Pyrazinamide used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

1023 P340 Rifampicin 150 mg +Isoniazid 75 STOP TB patient kit (DOTS) Combination Rifampicin 150 mg Restricted and to be PP E 07.10.2017 - Product approved
mg + Pyrizinamide 400 mg Tablets +Isoniazid 75 mg + used for the National 31.07.2019 based on a
+Ethambutol 275 mg Pyrizinamide 400 mg program only (Pre- special request
- +Ethambutol 275 mg Authorization from a clinician
required before
import)

1024 P341 Rifampicin 150mg + Isoniazid 75 STOP TB patient kit (DOTS) Combination Rifampicin 150mg + Restricted and to be PP E 07.10.2017 - Product approved
mg Tablets Isoniazid 75 mg used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

1025 P342 Rifampicin 150mg + Isoniazid STOP TB patient kit (DOTS) Combination Rifampicin 150mg + Restricted and to be PP E 07.10.2017 - Product approved
75mg + Ethambutol 275mg + Category II Tablets Isoniazid 75mg + used for the National 31.07.2019 based on a
Pyrazinamide 400mg / Rifampicin Ethambutol 275mg + program only (Pre- special request
150mg + Isoniazid 75mg + Pyrazinamide 400mg / Authorization from a clinician
Ethambutol 275mg / Rifampicin Rifampicin 150mg + required before
150mg + Isoniazid 75m/ Isoniazid 75mg + import)
-
Streptomycine injection 1g Ethambutol 275mg /
Rifampicin 150mg +
Isoniazid 75m/
Streptomycine injection
1g

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 149 of 189 Authorized by:DG,MFDA
 1026 P360 Rifampicin 450mg +Dapsone MDT (PB) child dose Combination Rifampicin 450mg Restricted and to be PP 07.10.2017 - Product approved
50mg And Dapsone 50mg Tablets +Dapsone 50mg And used for the National 31.07.2019 based on a
Dapsone 50mg program only (Pre- special request
- Authorization from a clinician
required before
import)

1027 P359 Rifampicin 600mg +Dapsone MDT (PB) adult dose Combination Rifampicin 600mg Restricted and to be PP 07.10.2017 - Product approved
100mg And Dapsone 100mg Tablets +Dapsone 100mg And used for the National 31.07.2019 based on a
Dapsone 100mg program only (Pre- special request
- Authorization from a clinician
required before
import)

1028 P2554 RISPERIDONE RISPERIDONE Injection 1mg/ml POM (Pre- PP E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1029 P2553 RISPERIDONE RISPERIDONE Oral Liquid 1mg/ml POM (Pre- PP E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1030 P2551 RISPERIDONE RISPERIDONE Tablet 0.25 mg POM (Pre- PP E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1031 P2552 RISPERIDONE RISPERIDONE Tablet 0.5 mg POM (Pre- PP E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1032 P396 Ritonavir Ritonavir Oral Liquid 400mg/5ml Restricted and to be PP 07.10.2017 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 150 of 189 Authorized by:DG,MFDA
 1033 P397 Ritonavir Ritonavir Tablet 25mg Restricted and to be PP 07.10.2017 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

1034 P398 Ritonavir Ritonavir Tablet 100mg Restricted and to be PP 07.10.2017 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

1035 P3308 RITUXIMAB Rituximab Injection 100 mg/ 10 ml Restricted for TA 10.02.2015 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

1036 P3309 RITUXIMAB Rituximab Injection 500 mg/ 10 ml Restricted for TA 10.02.2015 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

1037 P3348 RIVAROXABAN Rivaroxaban Tablet 10 mg POM (Pre- TA 17.02.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
- import) from a clinician

1038 P3349 RIVAROXABAN Rivaroxaban Tablet 15 mg POM (Pre- TA 17.02.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
- import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 151 of 189 Authorized by:DG,MFDA
 1039 P3350 RIVAROXABAN Rivaroxaban Tablet 20 mg POM (Pre- TA 17.02.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
- import) from a clinician

1040 P2072 RIVASTIGMINE RIVASTIGMINE Tablet 1.5 mg POM (Pre- PP 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1041 P2073 RIVASTIGMINE RIVASTIGMINE Tablet 3 mg POM (Pre- PP 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1042 P2074 RIVASTIGMINE RIVASTIGMINE Tablet 4.5 mg POM (Pre- PP 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1043 P2075 RIVASTIGMINE RIVASTIGMINE Tablet 6 mg POM (Pre- PP 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1044 P4299 ROCURONIUM BROMIDE ROCURONIUM BROMIDE Injection 50mg Restricted for TA 24.07.2018 - Product approved
Hospital Use Only 23.07.2019 based on a
(Pre-authorization special request
-
required before from a clinician
import)

1045 P4310 ROPIVACAINE HYDROCHLORIDE Ropivacaine Hydrochloride Injection 2mg/ml Restricted for TA 02.10.2018 - Product approved
Hospital Use Only 01.10.2019 based on a
(Pre-authorization special request
-
required before from a clinician
import)

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 152 of 189 Authorized by:DG,MFDA
 1046 P3881 ROPIVACAINE HYDROCHLORIDE ROPIVACAINE Injection 7.5mg /ml Restricted for TA 07.11.2016 - Product approved
HYDROCHLORIDE Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

1047 P3705 SALCATONIN Salcatonin Injection 50 units Restricted for PP 03.05.2016 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

1048 P3706 SALCATONIN Salcatonin Injection 100 units Restricted for PP 03.05.2016 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

1049 P3029 Salicylic acid Salicylic acid Solution 5% POM (Pre- PP E 20.05.2014 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1050 P415 Saquinavir Saquinavir Oral Liquid 200mg Restricted and to be PP 07.10.2017 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

1051 P416 Saquinavir Saquinavir Oral Liquid 500 mg Restricted and to be PP 07.10.2017 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

1052 P1435 SECNIDAZOLE SECNIDAZOLE Tablet 500 mg POM (Pre- PP 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 153 of 189 Authorized by:DG,MFDA
 1053 P1434 SECNIDAZOLE SECNIDAZOLE Oral Liquid 500 mg POM (Pre- PP 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1054 P1436 SECNIDAZOLE SECNIDAZOLE Tablet 1 gm POM (Pre- PP 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1055 P2061 SERTRALINE SERTRALINE Tablet 50 mg POM (Pre- PP 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1056 P4346 SERTRALINE SERTRALINE - Tablet 100mg POM (Pre- TA 16.10.2018 - Product
authorization 15.10.2019 approved based
required before on a special
import) request from a
clinician
1057 P3311 SEVELAMER Sevelamer Tablet 800 mg POM (Pre- TA 10.02.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1058 P3185 SEVELAMER SEVELAMER Tablet (Chewable) 400 mg Restricted for EA 08.10.2017 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

1059 P3376 SILDENAFIL Sildenafil Injection 10mg/ 12.5 ml Restricted for TA 17.02.2015 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 154 of 189 Authorized by:DG,MFDA
 1060 P3375 SILDENAFIL Sildenafil Tablet 20 mg POM (Pre- TA 17.02.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1061 P3377 SILDENAFIL Sildenafil Oral Liquid 10mg/ml POM (Pre- TA 17.02.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1062 P1359 SILDENAFIL SILDENAFIL Tablet 25 mg POM (Pre- PP E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1063 P4252 SILODOSIN SILODOSIN - Capsule 8mg POM (Pre- TA 10.04.2018 - Product approved
authorization 31.07.2019 based on a
required before special request
import) from a clinician

1064 P3887 SILODOSIN SILODOSIN Capsule 4mg POM (Pre- TA 07.11.2016 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1065 P3903 SILODOSIN SILODOSIN Tablet 8mg POM (Pre- TA 07.11.2016 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1066 P4044 SIMETHICONE Simethicone Tablet 80mg OTC (Pre- TA E 08.10.2017 - Product approved
Authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 155 of 189 Authorized by:DG,MFDA
 1067 P4046 SIMETHICONE Simethicone Oral Drops 40MG/5ML OTC (Pre- TA E 08.10.2017 - Product approved
Authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1068 P3310 SIROLIMUS Sirolimus Tablet 0.5 mg POM (Pre- TA 10.02.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1069 P2364 SIROLIMUS SIROLIMUS Tablet 1 mg POM (Pre- TA 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1070 P2365 SIROLIMUS SIROLIMUS Tablet 2 mg POM (Pre- TA 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1071 P2366 SIROLIMUS SIROLIMUS Tablet 3 mg POM (Pre- TA 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1072 P2363 SIROLIMUS SIROLIMUS Oral Liquid 1 mg/ml POM (Pre- TA 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1073 P3393 SITAGLIPTIN PHOSPHATE Sitagliptin Tablet 50mg+500mg POM (Pre- TA 17.02.2015 - Product approved
+METFORMIN HCL phosphate+Metformin Hcl authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 156 of 189 Authorized by:DG,MFDA
 1074 P4047 SNAKE ANTIVENOM Snake Antivenom Solution - Restricted for TA E 08.10.2017 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

1075 P4048 SODIUM ALGINATE + Sodium Alginate + Oral Solution - POM (Pre- TA E 08.10.2017 - Product approved
MAGNESIUM ALGINATE Magnesium Alginate authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1076 P4049 SODIUM ALGINATE + Sodium Alginate + Powder - POM (Pre- TA E 08.10.2017 - Product approved
MAGNESIUM ALGINATE Magnesium Alginate authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1077 P3915 SODIUM BICARBONATE SODIUM BICARBONATE Tablet 500 mg POM (Pre- TA 07.11.2016 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1078 P3085 SODIUM BICARBONATE Sodium Bicarbonate Injection 1.40% POM (Pre- PP E 20.05.2014 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1079 P3540 SODIUM CHLORIDE Sodium Chloride Eye Drops 5% POM (Pre- TA 30.06.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1080 P3909 SODIUM CHLORIDE SODIUM CHLORIDE IV Injection 0.03 Restricted for TA 07.11.2016 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 157 of 189 Authorized by:DG,MFDA
 1081 P4176 SODIUM CHLORIDE + POTASSIUM SODIUM CHLORIDE + Electrolyte Ice 2.5mg + 2.2mg + 4.8mg OTC (Pre- TA 08.03.2018 - Product approved
CHLORIDE + CITRIC ACID POTASSIUM CHLORIDE + Blocks (Orange + 16mg (1ml) Authorization 31.07.2019 based on a
MONOHYDRATE + GLUCOSE CITRIC ACID MONOHYDRATE Flavour) required before special request
-
+ GLUCOSE (Hydralyte) import) from a clinician

1082 P4177 SODIUM CHLORIDE + POTASSIUM SODIUM CHLORIDE + Electrolyte Ice 2.5mg + 2.2mg + 4.8mg OTC (Pre- TA 08.03.2018 - Product approved
CHLORIDE + CITRIC ACID POTASSIUM CHLORIDE + Blocks (Apple + 16mg (1ml) Authorization 31.07.2019 based on a
MONOHYDRATE + GLUCOSE CITRIC ACID MONOHYDRATE Blackcurrant required before special request
-
+ GLUCOSE (Hydralyte) Flavour) import) from a clinician

1083 P4296 SODIUM CHLORIDE + POTASSIUM SODIUM CHLORIDE + Electrolyte Ice 2.5mg + 2.2mg + 4.8mg OTC (Pre- TA 04.06.2018 - Product
CHLORIDE + CITRIC ACID POTASSIUM CHLORIDE + Blocks (Lemonade + 16mg (1ml) Authorization 31.07.2019 approved based
MONOHYDRATE + GLUCOSE CITRIC ACID MONOHYDRATE Flavour) required before on a special
- request from a
+ GLUCOSE (Hydralyte) import)
clinician

1084 P4373 SODIUM CHLORIDE + SODIUM SODIUM CHLORIDE + - Sachet (powder 2300mg + 700mg POM (Pre- TA 23.10.2018 - Product approved
BICARBONATE SODIUM BICARBONATE for authorization 22.10.2019 based on a
reconstitution) required before special request
import) from a clinician

1085 P4107 SODIUM CHLORIDE IP + SODIUM Sodium Chloride IP + Sodium Injection 0.526 g +0.502 g + 0.368 Restricted for TA 05.12.2017 - Product approved
GLUCONATE SP + SODIUM Gluconate SP + Sodium g +0.037 g +IP 0.030 g Hospital use only (Pre- 31.07.2019 based on a
ACETATE TRIHYDRATE IP + Acetate Trihydrate IP + Authorization special request
POTASSIUM CHLORIDE IP + Potassium Chloride IP + required before from a clinician
-
MAGNESIUM CHLORIDE Magnesium Chloride import)
HEXAHYDRATE IP + WATER FOR Hexahydrate IP + Water for
INJECTIONS IP Q,S Injections IP q.s.

1086 P24 SODIUM CHONDROITIN SODIUM CHONDROITIN Injection 40 mg + 30 mg per ml Restricted for PP E 07.10.2017 - Product approved
SULPHATE + SODIUM SULPHATE + SODIUM (0.75ml) Hospital use only (Pre- 31.07.2019 based on a
HYALURONATE HYALURONATE authorization special request
-
required before from a clinician
import)

1087 P1437 SODIUM CROMOGLYCATE SODIUM CROMOGLYCATE Eye Drops 2% POM (Pre- PP E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 158 of 189 Authorized by:DG,MFDA
 1088 P1054 SODIUM FUSIDATE ( FUSIDIC SODIUM FUSIDATE Topical Ointment 2% OTC (Pre- PP E 07.10.2017 - Product approved
ACID ) Authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1089 P1701 SODIUM NITRITE sodium nitrite Injection Injection 30 mg/ml in 10-ml POM (Pre- PP E 07.10.2017 - Product approved
ampule authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1090 P4050 SODIUM PHOSPHATE Sodium Phosphate Disposible Enema - POM (Pre- TA E 08.10.2017 - Product approved
MONOHYDRATE + SODIUM Monohydrate + Sodium authorization 31.07.2019 based on a
PHOSPHATE HEPTA HYDRATE Phosphate Hepta Hydrate required before special request
-
import) from a clinician

1091 P3186 SODIUM POLYSTYRENE Resonium A Powder for Oral 15 g Restricted for TA 06.11.2014 - Product approved
SULFONATE /Rectal Solution Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

1092 P2081 SODIUM VALPORATE SODIUM VALPORATE Tablet 500 mg POM (Pre- PP 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1093 P3318 SODIUM VALPORATE SODIUM VALPORATE Tablet 400 mg POM (Pre- TA 10.02.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1094 P1635 SODIUM VALPORATE SODIUM VALPORATE Tablet 100 mg POM (Pre- PP E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 159 of 189 Authorized by:DG,MFDA
 1095 P3911 SODIUM VALPROATE SODIUM VALPROATE Injection 100mg Restricted for TA 07.11.2016 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

1096 P4414 SOFOSBUVIR Sofobuvir - Tablet 400mg Restricted and to be TA E 04.02.2019 - Product approved
used for the National 05.02.2020 based on a
program only (Pre- Essential
Authorization Medicine List
required before 2018
import)

1097 P3921 SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE Tablet 5mg POM (Pre- TA 07.11.2016 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1098 P2460 Somatostatin Somatostatin injection 0.25mg, 3mg Restricted for PP 07.10.2017 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

1099 P4453 SORAFENIB SORAFENIB - Film coated tablet 200mg POM (Pre- TA 09.04.2019 - Product approved
authorization 08.04.2020 based on a
required before special request
import) from a clinician

1100 P3642 SOYA BEANS OIL + MCT + OLIVE SOYA BEANS OIL + MCT + Injections 30% + 30%+ 25% + 15% Restricted for TA 19.01.2016 - Product approved
OIL + FISH OIL + VITAMIN E OLIVE OIL + FISH OIL + +200 mg/dl Hospital use only (Pre- 31.07.2019 based on a
VITAMIN E Authorization Each special request
required before Shipment from a clinician
- import) should be
accompanied
by the batch
certificates

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 160 of 189 Authorized by:DG,MFDA
 1101 P3638 SOYA-BEAN OIL+ REFINED SOYA-BEAN OIL+ REFINED EMULSION FOR 60G+ Restricted for TA 19.01.2016 - Product approved
PH.EUR 60G+TRIGLYCERIDES + PH.EUR 60G+TRIGLYCERIDES INFUSION 60G+50G+30G+163.225 Hospital use only (Pre- 31.07.2019 based on a
MEDIUM CHAIN PH.EUR 60G+ + MEDIUM CHAIN PH.EUR MG+25G+12G+0.3G Authorization Each special request
OLIVE OIL + REFINED PH.EUR 60G+ OLIVE OIL + REFINED (20%) required before Shipment from a clinician
50G+FISH OIL + RICH IN OMEGA3- PH.EUR 50G+FISH OIL + RICH import) should be
ACIDS PH.EUR 30G+ ALL-RAC-A- + IN OMEGA3-ACIDS PH.EUR accompanied
TROCOPHEROL PH.EUR 163- 30G+ ALL-RAC-A- + by the batch
225MG+ GLYCEROL TROCOPHEROL PH.EUR 163- certificates
(ANHYDROUS) PH.EUR 25G+ EGG 225MG+ GLYCEROL
LECITHIN 12G+ SODIUM (ANHYDROUS) PH.EUR 25G+
HYDROXIDE PH.EUR TO APPROX EGG LECITHIN 12G+ SODIUM -
PH8+ SODIUM OLEATE 0.3G+ HYDROXIDE PH.EUR TO
ENERGY CONTENT 8.4MJ/I APPROX PH8+ SODIUM
(2000KCAL/L) PH APPROX 8 + OLEATE 0.3G+ ENERGY
OSMOLALITY 380MOSM/KG H2O CONTENT 8.4MJ/I
(2000KCAL/L) PH APPROX 8 +
OSMOLALITY 380MOSM/KG
H2O (SMOflipid 20%)

1102 P1451 SPIRAMYCIN SPIRAMYCIN Oral Liquid 0.375 miu /5 ml POM (Pre- PP 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1103 P1452 SPIRAMYCIN SPIRAMYCIN Tablet 1.5 MIU POM (Pre- PP 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1104 P1453 SPIRAMYCIN SPIRAMYCIN Tablet 3 MIU POM (Pre- PP 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1105 P391 Stavudin Stavudin Capsule 30 mg Restricted and to be PP 07.10.2017 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 161 of 189 Authorized by:DG,MFDA
 1106 P392 Stavudin Stavudin Capsule 15 mg Restricted and to be PP 07.10.2017 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

1107 P393 Stavudin Stavudin Capsule 20 mg Restricted and to be PP 07.10.2017 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

1108 P394 Stavudin Stavudin Oral Liquid 5 mg/5ml Restricted and to be PP 07.10.2017 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

1109 P395 Stavudin Stavudin Tablet 40 mg Restricted and to be PP 07.10.2017 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

1110 P899 STREPTOKINASE STREPTOKINASE Injection 750000 IU Restricted for EA E 08.10.2017 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

1111 P900 STREPTOKINASE STREPTOKINASE - Injection 1500000 IU Restricted for TA E 08.10.2017 - Product approved
Hospital Use Only 31.07.2019 based on a
(Pre-authorization special request
required before from a clinician
import)

1112 P2973 Streptomycin Streptomycin Injection 1 gm Restricted for PP E 20.05.2014 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 162 of 189 Authorized by:DG,MFDA
 1113 P742 SUCCINYL CHOLINE SUCCINYL CHOLINE Injection 50mg/ml Restricted for TA E 08.10.2017 - MTG/RE-MA/Fo
Hospital use only (Pre- 31.07.2019 0012/2019-0008
- authorization
required before
import)
1114 P4051 SUCRALFATE Sucralfate Oral suspension 1000mg /10ml POM (Pre- TA E 08.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1115 P4052 SUCROSE Sucrose Oral Solution 20% POM (Pre- TA E 08.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1116 P4053 SUCROSE Sucrose Oral Solution 25% POM (Pre- TA E 08.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1117 P352 Sulfadoxine + Pyrimethamine Sulfadoxine and Tablet 500mg + 25mg Restricted and to be PP 07.10.2017 - Product approved
pyrimethamine used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

1118 P2961 Sulfamethoxazole + trimethoprim Sulfamethoxazole + Oral Liquid 200 mg + 40 mg/5 ml POM (Pre- TA E 20.05.2014 - Product approved
trimethoprim authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1119 P2959 Sulfamethoxazole + trimethoprim Sulfamethoxazole + Tablet 100 mg + 20 mg POM (Pre- TA E 20.05.2014 - Product approved
trimethoprim authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 163 of 189 Authorized by:DG,MFDA
 1120 P2960 Sulfamethoxazole + trimethoprim Sulfamethoxazole + Tablet 400 mg + 80 mg POM (Pre- TA E 20.05.2014 - Product approved
trimethoprim authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1121 P3424 SULFASALAZINE Sulfsalazine Tablet 500 mg POM (Pre- TA 24.03.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1122 P2986 Sulphadiazine Sulphadiazine Tablet 500mg POM (Pre- PP E 20.05.2014 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1123 P3844 SULPHAMETHOXAZOLE + Sulphamethoxazole+Trimeth Syrup 400 +80 mg POM (Pre- TA 01.11.2016 - Product approved
TRIMETHOPRIM oprim authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1124 P3859 SULPHAMETHOXAZOLE + SULPHAMETHOXAZOLE + Tablet 800mg+160mg POM (Pre- TA 07.11.2016 - Product approved
TRIMETHOPRIM TRIMETHOPRIM authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1125 P1702 SUMATRIPTAN Sumatriptan Tablet 25mg POM (Pre- PP 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1126 P3227 SUMATRIPTAN Sumatriptan Tablet 50 mg POM (Pre- PP 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 164 of 189 Authorized by:DG,MFDA
 1127 P2301 SUNITINIB SUNITINIB Tablet 50 mg POM (Pre- TA 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1128 P4362 SUNITINIB MALATE SUNITINIB MALATE - Hard capsule 25mg POM (Pre- TA 23.10.2018 - Product approved
authorization 22.10.2019 based on a
required before special request
import) from a clinician

1129 P4363 SUNITINIB MALATE SUNITINIB MALATE - Hard capsule 12.5mg POM (Pre- TA 23.10.2018 - Product approved
authorization 22.10.2019 based on a
required before special request
import) from a clinician

1130 P3099 Surfactant Surfactant injection 5 ml Restricted for EA 20.05.2014 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

1131 P3391 TACROLIMUS Tacrolimus Tablet 2 mg POM (Pre- TA 17.02.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1132 P2765 Tacrolimus Tacrolimus Capsule 5 mg POM (Pre- TA 08.05.2013 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1133 P2766 Tacrolimus Tacrolimus Injection 5mg/ml POM (Pre- TA 08.05.2013 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 165 of 189 Authorized by:DG,MFDA
 1134 P3799 TADALAFIL Tadalafil Tablet 10mg POM (Pre- TA 11.10.2016 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1135 P3879 TADALAFIL TADALAFIL Tablet 5mg POM (Pre- TA 07.11.2016 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1136 P4215 TADALAFIL TADALAFIL - Tablet 20mg POM (Pre- TA 13.03.2018 - Product approved
authorization 31.07.2019 based on a
required before special request
import) from a clinician

1137 P1704 TAMOXIFEN Tamoxifen Tablet 20mg POM (Pre- PP E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1138 P1703 TAMOXIFEN Tamoxifen Tablet 10mg POM (Pre- PP E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1139 P4297 TAMSULOSIN + DUTASTERIDE TAMSULOSIN + Capsule 0.4mg + 0.5mg POM (Pre- TA 24.07.2018 - Product approved
DUTASTERIDE authorization 23.07.2019 based on a
required before special request
-
import) from a clinician

1140 P3833 TAMSULOSIN HCL Tamsulosin HCL Tablet 0.2 mg POM (Pre- TA 01.11.2016 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 166 of 189 Authorized by:DG,MFDA
 1141 P3848 TAMSULOSIN HCL + Tamsulosin HCL + Tablet 0.4 mg + 0.5 mg POM (Pre- TA 01.11.2016 - Product approved
DUTASTERIDE Dutasteride authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1142 P3894 TAPENTADOL TAPENTADOL Tablet 50mg CONTROLLED ( Pre- TA 07.11.2016 - Product approved
Authorization 31.07.2019 based on a
required before special request
-
import ) from a clinician

1143 P3645 TAURIN + N ACETYL TYROSINE + TAURIN + N ACETYL Injections 10% Restricted for TA 19.01.2016 - Product approved
N ACETYL CYSTETEINE TYROSINE + N ACETYL Hospital use only (Pre- 31.07.2019 based on a
CYSTETEINE Authorization Each special request
required before Shipment from a clinician
- import) should be
accompanied
by the batch
certificates

1144 P3387 TEICOPLANIN Teicoplanin Injection 200 mg Restricted for TA 17.02.2015 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

1145 P3388 TEICOPLANIN Teicoplanin Injection 400 mg Restricted for TA 17.02.2015 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

1146 P4085 TELMISARTAN + AMLODIPINE Telmisartan + Amlodipine Tablet 40mg + 5mg POM (Pre- TA 31.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1147 P4368 TEMOZOLOMIDE TEMOZOLOMIDE - Capsule 20mg POM (Pre- TA 23.10.2018 - Product approved
authorization 22.10.2019 based on a
required before special request
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 167 of 189 Authorized by:DG,MFDA
 1148 P4369 TEMOZOLOMIDE TEMOZOLOMIDE - Capsule 100mg POM (Pre- TA 23.10.2018 - Product approved
authorization 22.10.2019 based on a
required before special request
import) from a clinician

1149 P4370 TEMOZOLOMIDE TEMOZOLOMIDE - Capsule 250mg POM (Pre- TA 23.10.2018 - Product approved
authorization 22.10.2019 based on a
required before special request
import) from a clinician

1150 P2472 TENECTEPLASE TENECTEPLASE Injection 30 mg POM (Pre- TA 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1151 P2473 TENECTEPLASE TENECTEPLASE Injection 40 mg POM (Pre- TA 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1152 P2474 TENECTEPLASE TENECTEPLASE Injection 50 mg POM (Pre- TA 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1153 P3973 TENELIGLIPTIN Teneligliptin Tablet 20mg POM (Pre- TA 06.06.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1154 P3971 TENELIGLIPTIN + METFORMIN Teneligliptin + Metformin Tablet (Extended 20mg + 1000mg POM (Pre- TA 06.06.2017 - Product approved
Release) authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 168 of 189 Authorized by:DG,MFDA
 1155 P3972 TENELIGLIPTIN + METFORMIN Teneligliptin + Metformin Tablet (Extended 20mg + 500mg POM (Pre- TA 06.06.2017 - Product approved
Release) authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1156 P403 Tenofovir Tenofovir Tablet 300mg Restricted and to be PP 07.10.2017 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

1157 P90 TERBUTALINE TERBUTALINE Injection 0.5 mg/ml POM (Pre- PP E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1158 P92 TERBUTALINE TERBUTALINE Nebulising 10 mg/ml POM (Pre- PP E 07.10.2017 - Product approved
Solution authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1159 P93 TERBUTALINE TERBUTALINE Tablet 2.5 mg POM (Pre- PP E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1160 P94 TERBUTALINE TERBUTALINE Tablet 5 mg POM (Pre- PP E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1161 P89 TERBUTALINE TERBUTALINE Aerosol 0.25 mg/md 400mds POM (Pre- PP E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 169 of 189 Authorized by:DG,MFDA
 1162 P3707 TERIPARATIDE Teriparatide Injection 750mcg/3ml Restricted for PP 03.05.2016 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

1163 P3307 TERLIPRESSIN Terlipressin Injection 1 mg Restricted for TA 10.02.2015 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

1164 P4054 TERLIPRESSIN Terlipressin Injection 2mg Restricted for TA E 08.10.2017 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

1165 P912 TESTOSTERONE TESTOSTERONE Capsule 40 mg Restricted for PP 07.10.2017 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

1166 P600 TESTOSTERONE TESTOSTERONE Injection 100mg Restricted for PP 07.10.2017 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

1167 P601 TESTOSTERONE TESTOSTERONE Injection 250mg Restricted for PP 07.10.2017 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

1168 P913 TESTOSTERONE TESTOSTERONE Injection 100 mg/ml Restricted for PP 07.10.2017 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 170 of 189 Authorized by:DG,MFDA
 1169 P3905 TESTOSTERONE TESTOSTERONE Injection 1G Restricted for TA 07.11.2016 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

1170 P1546 TETANUS ANTITOXIN TETANUS ANTITOXIN Injection 250 mg Restricted for PP E 07.10.2017 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

1171 P1547 TETANUS ANTITOXIN TETANUS ANTITOXIN Injection 500 mg Restricted for PP E 07.10.2017 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

1172 P3066 TETRACAINE Tetracaine Eye Drops 0.50% POM (Pre- PP E 20.05.2014 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1173 P3671 TETRACOSACTIDE HEXA-ACETATE Tetracosactide Hexa-acetate Injection 250 mcg/ml Restricted for TA 23.02.2016 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

1174 P1300 TETRACYCLINE TETRACYCLINE Capsule 250mg POM (Pre- PP E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1175 P1360 TETRAHYDROZOLINE TETRAHYDROZOLINE Eye Drops 0.05% POM (Pre- PP 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 171 of 189 Authorized by:DG,MFDA
 1176 P4055 THEOPHYLLINE Theophylline Oral Liquid POM (Pre- TA E 08.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1177 P3316 THIAMINE Thiamine Injection 200mg/2 ml Restricted for TA 10.02.2015 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

1178 P3315 THIAMINE Thiamine Tablet 250mg POM (Pre- TA 10.02.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1179 P3317 THIAMINE Thiamine Tablet 500mg POM (Pre- TA 10.02.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1180 P3314 THIAMINE Thiamine Tablet 100mg POM (Pre- TA 10.02.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1181 P1438 THIOPENTAL SODIUM THIOPENTAL SODIUM Injection 1 gm Restricted for PP E 07.10.2017 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

1182 P2555 THIORIDAZINE Thioridazine Tablet 50 mg POM (Pre- PP 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 172 of 189 Authorized by:DG,MFDA
 1183 P1639 THIORIDAZINE THIORIDAZINE Tablet 25mg POM (Pre- PP 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1184 P3835 THYROXINE SODIUM Thyroxine Sodium Tablet 12.5 mg POM (Pre- TA 01.11.2016 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1185 P3798 TICAGRELOR Ticagrelor Film-coated 90mg POM (Pre- TA 11.10.2016 - Product approved
Tablet authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1186 P3811 TIGECYCLINE Tigecycline Injection 50 mg Restricted for TA 01.11.2016 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

1187 P4056 TINIDAZOLE Tinidazole Tablet 2gm POM (Pre- TA E 08.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1188 P1044 TINZAPARIN TINZAPARIN Injection 20000Anti-xa IU/ml Restricted for PP 07.10.2017 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

1189 P3385 TIOTROPIUM BROMIDE Tiotropium Bromide Inhalation 9 mcg/Puff POM (Pre- TA 17.02.2015 - Product approved
Capsule authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 173 of 189 Authorized by:DG,MFDA
 1190 P3386 TIOTROPIUM BROMIDE Tiotropium Bromide Inhalation 18 mcg/Puff POM (Pre- TA 17.02.2015 - Product approved
Capsule authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1191 P4374 TIROFIBAN HYDROCHLORIDE TIROFIBAN HYDROCHLORIDE - Solution for 50mcg/ml (5mg/100ml) Restricted for TA 23.10.2018 - Product approved
Infusion Hospital Use Only 22.10.2019 based on a
(Pre-authorization special request
required before from a clinician
import)

1192 P3373 TOBRAMYCIN Tobramycin Inhalation 300 mg/4 ml POM (Pre- TA 17.02.2015 - Product approved
Solution (powder) authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1193 P3374 TOBRAMYCIN Tobramycin Inhalation 300 mg/ 5 ml POM (Pre- TA 17.02.2015 - Product approved
Solution (powder) authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1194 P3428 TOCILLIZUMAB Tocilizumab Injection 20 mg/ml Restricted for TA 24.03.2015 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

1195 P3427 TOCILLIZUMAB Tocilizumab Injection 162 mg/0.9 ml Restricted for TA 24.03.2015 - Product approved
(Prefilled) Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

1196 P3834 TOLTERODINE Tolterodine Capsule 2 mg POM (Pre- TA 01.11.2016 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 174 of 189 Authorized by:DG,MFDA
 1197 P2368 TOLTERODINE TARTRATE Tolterodine Tartrate Tablet 1mg POM (Pre- TA 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1198 P2369 TOLTERODINE TARTRATE Tolterodine Tartrate Tablet 2 mg POM (Pre- TA 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1199 P2370 TOLTERODINE TARTRATE Tolterodine Tartrate Tablet 4 mg POM (Pre- TA 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1200 P4425 TOLTERODINE TARTRATE TOLTERODINE TARTRATE Prolonged release 4mg POM (Pre- TA 19.03.2019 - Product approved
hard capsule authorization 18.03.2020 based on a
required before special request
-
import) from a clinician

1201 P3351 TOLVAPTAN Tolvaptan Tablet 15 mg POM (Pre- TA 17.02.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1202 P3352 TOLVAPTAN Tolvaptan Tablet 30 mg POM (Pre- TA 17.02.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1203 P951 TOPIRAMATE TOPIRAMATE - Tablet 50mg POM (Pre- PP 08.11.2018 - 07.11.2019
authorization
required before
import)

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 175 of 189 Authorized by:DG,MFDA
 1204 P950 TOPIRAMATE TOPIRAMATE - Film coated tablet 25mg POM (Pre- PP 08.11.2018 - 07.11.2019
authorization
required before
import)

1205 P4264 TOPOTECAN TOPOTECAN - Hard capsule 0.25mg POM (Pre- TA 10.04.2018 - Product approved
authorization 31.07.2019 based on a
required before special request
import) from a clinician

1206 P4265 TOPOTECAN TOPOTECAN - Hard capsule 1mg POM (Pre- TA 10.04.2018 - Product approved
authorization 31.07.2019 based on a
required before special request
import) from a clinician

1207 P4266 TOPOTECAN TOPOTECAN - Powder for 1mg/ml Restricted for TA 10.04.2018 - Product approved
infusion Hospital Use Only 31.07.2019 based on a
(Pre-authorization special request
required before from a clinician
import)

1208 P4267 TOPOTECAN TOPOTECAN - Powder for 4mg/4ml Restricted for TA 10.04.2018 - Product approved
infusion Hospital Use Only 31.07.2019 based on a
(Pre-authorization special request
required before from a clinician
import)

1209 P4268 TOPOTECAN TOPOTECAN - Powder for 4mg/vial Restricted for TA 10.04.2018 - Product approved
infusion Hospital Use Only 31.07.2019 based on a
(Pre-authorization special request
required before from a clinician
import)

1210 P3357 TORSEMIDE Torsemide Tablet 5 mg POM (Pre- TA 17.02.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 176 of 189 Authorized by:DG,MFDA
 1211 P3358 TORSEMIDE Torsemide Tablet 100 mg POM (Pre- TA 17.02.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1212 P3359 TORSEMIDE Torsemide Injection 10 mg/ml Restricted for TA 17.02.2015 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

1213 P3183 TORSEMIDE Torsemide Tablet 10 mg POM (Pre- TA 06.11.2014 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1214 P3184 TORSEMIDE Torsemide Tablet 20 mg POM (Pre- TA 06.11.2014 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1215 P3809 TRAMADOLE + PARACETAMOL Tramadol Hydrochloride + Tablet 37.5 mg + 325 mg CONTROLLED ( Pre- TA 01.11.2016 - Product approved
Paracetamol Authorization 31.07.2019 based on a
required before special request
-
import ) from a clinician

1216 P4057 TRANEXAMIC ACID Tranxenemic Acid Tablet 100mg POM (Pre- TA E 08.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1217 P4058 TRANEXAMIC ACID Tranxenemic Acid Injection 100mg/ml Restricted for TA E 08.10.2017 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
authorization special request
-
required before from a clinician
import)

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 177 of 189 Authorized by:DG,MFDA
 1218 P4271 TRASTUZUMAB TRASTUZUMAB - Injection 440mg/vial Restricted for TA 10.04.2018 - Product approved
Hospital Use Only 31.07.2019 based on a
(Pre-authorization special request
required before from a clinician
import)

1219 P4458 TRASTUZUMAB TRASTUZUMAB - Powder for 150mg Restricted for TA 09.04.2019 - Product approved
concentrate for Hospital Use Only 08.04.2020 based on a
solution for (Pre-authorization special request
infusion required before from a clinician
import)

1220 P947 TRETINOIN TRETINOIN - Cream 0.05% POM (Pre- TA 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
import) from a clinician

1221 P946 TRETINOIN TRETINOIN - Cream 0.025% POM (Pre- PP 07.10.2017 - 31.07.2019
authorization
required before
import)
1222 P4360 TRETINOIN (TRANS RETINOIC TRETINOIN - Softgel Capsule 10mg POM (Pre- TA 23.10.2018 - Product approved
ACID) authorization 22.10.2019 based on a
required before special request
import) from a clinician

1223 P205 TRIAMCINOLONE TRIAMCINOLONE Injection 40 mg POM (Pre- PP 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1224 P4059 TRICHLOROACETIC ACID TRICHLOROACETIC ACID Chemical Peel 15% POM (Pre- TA E 08.10.2017 - Product approved
(crystal) authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1225 P4178 TRICHLOROACETIC ACID TRICHLOROACETIC ACID Chemical Peel 25% POM (Pre- TA E 08.10.2017 - Product approved
(crystal) authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 178 of 189 Authorized by:DG,MFDA
 1226 P4240 TRICLOFOS TRICLOFOS - Syrup 500mg/5ml POM (Pre- TA 10.04.2018 - Product approved
authorization 31.07.2019 based on a
required before special request
import) from a clinician

1227 P2595 TRIHEXYPHENIDYL Trihexyphenidyl Oral Liquid 2 mg/ 5 ml Restricted for TA E 07.10.2017 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

1228 P2594 TRIHEXYPHENIDYL Trihexyphenidyl Tablet 5 mg Restricted for TA E 07.10.2017 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

1229 P3906 TRIMETAZIDINE HYDROCHLORIDE TRIMETAZIDINE Tablet 35mg POM (Pre- TA 07.11.2016 - Product approved
HYDROCHLORIDE authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1230 P1454 TRIMIPRAMINE TRIMIPRAMINE Tablet 25 mg POM (Pre- PP 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1231 P1455 TRIMIPRAMINE TRIMIPRAMINE Tablet 10 mg POM (Pre- PP 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1232 P3787 TRIPTORELIN ACETATE Triptorelin Acetate Powder for 100mcg Restricted for TA 11.10.2016 - Product approved
Injection Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 179 of 189 Authorized by:DG,MFDA
 1233 P4060 TROPICAMIDE Tropicamide Eye Drops 0.50% POM (Pre- TA E 08.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1234 P4061 TRYPAN BLUE Trypan Blue Solution 0.06% Restricted for TA E 08.10.2017 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

1235 P262 TRYPSIN + CHYMOTRYPSIN TRYPSIN + CHYMOTRYPSIN - Enteric coated 100,000 units POM (Pre- TA
(100,000 ARMOUR UNITS OF (100,000 ARMOUR UNITS OF tablet authorization
ENZYMATIC ACTIVITY) ENZYMATIC ACTIVITY) required before
import)
1236 P4377 TWO COMPONENT FIBRIN TWO COMPONENT FIBRIN - Powder and Component 1: 91mg + Restricted for TA 23.10.2018 - Product approved
SEALANT (Component 1: Sealer SEALANT (Component 1: solvent for 3000 KIU Hospital Use Only 22.10.2019 based on a
protein solution (Human Sealer protein solution sealant Component 2: 500 IU + (Pre-authorization special request
fibrinogen - as clottable protein + (Human fibrinogen - as 40 umol required before from a clinician
Synthetic Aptotinin) & clottable protein + Synthetic (2ml) import)
Component 2: Thrombin Solution Aptotinin) &
(Human thrombin + Calcium Component 2: Thrombin
Chloride) Solution (Human thrombin +
Calcium Chloride)

1237 P4378 TWO COMPONENT FIBRIN TWO COMPONENT FIBRIN - Powder and Component 1: 182mg + Restricted for TA 23.10.2018 - Product approved
SEALANT (Component 1: Sealer SEALANT (Component 1: solvent for 6000 KIU Hospital Use Only 22.10.2019 based on a
protein solution (Human Sealer protein solution sealant Component 2: 1000 IU + (Pre-authorization special request
fibrinogen - as clottable protein + (Human fibrinogen - as 80 umol required before from a clinician
Synthetic Aptotinin) & clottable protein + Synthetic (4ml) import)
Component 2: Thrombin Solution Aptotinin) &
(Human thrombin + Calcium Component 2: Thrombin
Chloride) Solution (Human thrombin +
Calcium Chloride)

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 180 of 189 Authorized by:DG,MFDA
 1238 P4379 TWO COMPONENT FIBRIN TWO COMPONENT FIBRIN - Powder and Component 1: 455mg + Restricted for TA 23.10.2018 - Product approved
SEALANT (Component 1: Sealer SEALANT (Component 1: solvent for 15000 KIU Hospital Use Only 22.10.2019 based on a
protein solution (Human Sealer protein solution sealant Component 2: 2500 IU + (Pre-authorization special request
fibrinogen - as clottable protein + (Human fibrinogen - as 200 umol required before from a clinician
Synthetic Aptotinin) & clottable protein + Synthetic (10ml) import)
Component 2: Thrombin Solution Aptotinin) &
(Human thrombin + Calcium Component 2: Thrombin
Chloride) Solution (Human thrombin +
Calcium Chloride)

1239 P3312 UNFRACTIONED HEPARIN Unfractioned Heparin(UFH) Injection 2500iu/ml Restricted for TA 10.02.2015 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

1240 P3313 UNFRACTIONED HEPARIN Unfractioned Heparin(UFH) Injection 5000iu/ml Restricted for TA 10.02.2015 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

1241 P1886 UROKINASE UROKINASE Injection 250000 IU/vial Restricted for TA 08.10.2017 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

1242 P1887 UROKINASE UROKINASE Injection 500000 IU/vial Restricted for TA 08.10.2017 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

1243 P3874 UROKINASE UROKINASE Injection 5000IU Restricted for TA 07.11.2016 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 181 of 189 Authorized by:DG,MFDA
 1244 P366 VACCINE BCG VACCINE BCG Injection lyophilized live BCG Restricted and to be PP E 07.10.2017 - Product approved
strain (freezed dried) used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

1245 P367 VACCINE DPT VACCINE DPT Injection min 30iu diptheria Restricted and to be PP E 07.10.2017 - Product approved
toxoid, min 4iu B used for the National 31.07.2019 based on a
Pertussis, 40iu tetanus program only (Pre- special request
- toxoid adjuvanted with Authorization from a clinician
Al(OH)3 and AlPO4 required before
/0.5ml amp import)

1246 P368 VACCINE DT VACCINE DT (Pediatric) Injection min 30iu diptheria Restricted and to be PP E 07.10.2017 - Product approved
toxoid, 40iu tetanus used for the National 31.07.2019 based on a
toxoid adjuvanted with program only (Pre- special request
- Al(OH)3 /0.5ml amp Authorization from a clinician
required before
import)

1247 P370 VACCINE MEASLES VACCINE MEASLES Injection min 1000 TCID50 of Restricted and to be PP E 07.10.2017 - Product approved
measles virus used for the National 31.07.2019 based on a
(attenuated Schwarz) program only (Pre- special request
- /0.5ml amp Authorization from a clinician
required before
import)

1248 P364 VACCINE MENINGITIS ACY W-135 VACCINE MENINGITIS Injection 50mcg of purified Restricted and to be PP E 07.10.2017 - Product approved
polysaccaride of used for the National 31.07.2019 based on a
N.menigitidis group A program only (Pre- special request
- and C 0.5ml/ Authorization from a clinician
required before
import)

1249 P365 VACCINE MMR VACCINE MMR Injection Live attenuated Restricted and to be PP E 07.10.2017 - Product approved
measles vaccine 1000 used for the National 31.07.2019 based on a
CCID-50' live attenuated program only (Pre- special request
- mumps vaccine 1000 Authorization from a clinician
CCID-50 required before
import)

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 182 of 189 Authorized by:DG,MFDA
 1250 P371 VACCINE POLIO VACCINE POLIO Oral Drops min 106 TCID50 of type Restricted and to be PP E 07.10.2017 - Product approved
I, min 105 TCID50 of used for the National 31.07.2019 based on a
type II min 3x105 program only (Pre- special request
- TCID50 of type III /0.1ml Authorization from a clinician
single tube required before
import)

1251 P1642 VALETHAMATE BROMIDE + VALETHAMATE BROMIDE + - Injection 8mg + 8mg/ml Restricted for TA E 06.02.2018 - Product approved
SODIUM CHLORIDE IP SODIUM CHLORIDE IP Hospital use only (Pre- 31.07.2019 based on a
authorization special request
required before from a clinician
import)

1252 P4298 VALGANCICLOVIR VALGANCICLOVIR Tablet 450mg POM (Pre- TA 24.07.2018 - Product approved
HYDROCHLORIDE HYDROCHLORIDE authorization 23.07.2019 based on a
required before special request
-
import) from a clinician

1253 P2962 VANCOMYCIN VANCOMYCIN Injection 250mg Restricted for PP E 20.05.2014 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

1254 P4062 VARICELLA ZOSTER Varicella Zoster Injection 125IU/vial Restricted and to be TA E 08.10.2017 - Product approved
IMMUNOGLOBULIN Immunoglobulin used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

1255 P4063 VARICELLA ZOSTER Varicella Zoster Injection 100IU/ml Restricted for TA E 08.10.2017 - Product approved
IMMUNOGLOBULIN Immunoglobulin Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

1256 P3291 VASOPRESSIN Vasopressin Injection 20 units/ml Restricted for TA 10.02.2015 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 183 of 189 Authorized by:DG,MFDA
 1257 P2832 VECURONIUM VECURONIUM Injection 4mg Restricted for EA 08.10.2017 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

1258 P3238 VENLAFAXINE Venlafaxine Tablet 25 mg POM (Pre- TA 20.01.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1259 P2090 VENLAFAXINE Venlafexine Tablet 75 mg POM (Pre- TA 20.01.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1260 P2556 VENLAFAXINE Venlafexine Tablet 37.5 mg POM (Pre- TA 20.01.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1261 P3015 VERAPAMIL VERAPAMIL Injection 2.5mg/ml POM (Pre- PP E 20.05.2014 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1262 P2587 VIGABARTIN Vigabartin Oral Liquid 500 mg POM (Pre- TA 05.06.2012 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1263 P2585 VIGABARTIN Vigabartin Sachet 500 mg POM (Pre- TA 05.06.2012 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 184 of 189 Authorized by:DG,MFDA
 1264 P2586 VIGABARTIN Vigabartin Tablet 500 mg POM (Pre- TA 05.06.2012 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1265 P4455 VINCRISTINE SULFATE VINCRISTINE SULFATE - Solution for 1mg/ml Restricted for TA 09.04.2019 - Product approved
Injection Hospital Use Only 08.04.2020 based on a
(Pre-authorization special request
required before from a clinician
import)

1266 P4459 VINORELBINE VINORELBINE - Concentrated 10mg/ml (5ml in a vial) Restricted for TA 09.04.2019 - Product approved
Solution for Hospital Use Only 08.04.2020 based on a
Infusion (Pre-authorization special request
required before from a clinician
import)

1267 P443 VITAMIN D3 VITAMIN D3 Injection 300000 iu/ml POM (Pre- PP E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1268 P444 VITAMIN D3 VITAMIN D3 Injection 600000 iu/ml POM (Pre- PP E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1269 P747 VITAMIN K (Phytomenadione) VITAMIN K Injection POM (Pre- PP E 07.10.2017 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1270 P3435 VOGLIBOSE Voglibose Tablet 0.2 mg POM (Pre- TA 24.03.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 185 of 189 Authorized by:DG,MFDA
 1271 P3436 VOGLIBOSE Voglibose Tablet 0.3 mg POM (Pre- TA 24.03.2015 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1272 P3920 VORICONAZOLE VORICONAZOLE Tablet 200MG POM (Pre- TA 07.11.2016 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1273 P2814 WATER FOR INJECTION Water for Injection Injection OTC (Pre- TA 08.10.2017 -
Authorization 31.07.2019
-
required before
import)
1274 P1255 XYLOMETAZOLINE XYLOMETAZOLINE Nasal Solution 0.1% w/v (10ml) POM (Pre- PP 05.07.2017 - Product approved
HYDROCHLORIDE HYDROCHLORIDE (Nasal Spray) authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1275 P374 YELLOW FEVER VACCINE Yellow fever Vaccine Injection 0.5ml (freeze dried) Restricted and to be PP 07.10.2017 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

1276 P382 ZIDOVUDINE Zidovudine/ azidothymidine Capsule 100 mg Restricted and to be PP 07.10.2017 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

1277 P383 ZIDOVUDINE Zidovudine/ azidothymidine Capsule 250 mg Restricted and to be PP 07.10.2017 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 186 of 189 Authorized by:DG,MFDA
 1278 P385 ZIDOVUDINE Zidovudine/ azidothymidine Injection 10mg/ml Restricted and to be PP 07.10.2017 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

1279 P2616 ZIDOVUDINE Zidovudine Oral Liquid 10 mg/ml Restricted and to be TA 10.07.2012 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

1280 P384 ZIDOVUDINE Zidovudine/ azidothymidine Oral Liquid 50mg/5ml Restricted and to be PP 07.10.2017 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

1281 P381 ZIDOVUDINE Zidovudine/ azidothymidine Tablet 300 mg Restricted and to be PP 07.10.2017 - Product approved
used for the National 31.07.2019 based on a
program only (Pre- special request
- Authorization from a clinician
required before
import)

1282 P3027 ZINC OXIDE Zinc oxide Paste,cream, POM (Pre- PP E 20.05.2014 - Product approved
powder authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1283 P1317 ZINC OXIDE +BISMUTH ZINC OXIDE +BISMUTH Topical Ointment 10.75 g + 2.25 g + 1.875 POM (Pre- PP E 07.10.2017 - Product approved
SUBGALLATE +BALSAM PERU SUBGALLATE +BALSAM PERU g +0.875 g in 100g authorization 31.07.2019 based on a
+BISMUTH OXIDE +BISMUTH OXIDE required before special request
-
import) from a clinician

1284 P2643 ZINC SULPHATE ZINC SULPHATE Oral Liquid 10mg /5 ml POM (Pre- TA 02.10.2012 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 187 of 189 Authorized by:DG,MFDA
 1285 P2642 ZINC SULPHATE ZINC SULPHATE Tablet 50 mg POM (Pre- TA 02.10.2012 - Product approved
authorization 31.07.2019 based on a
required before special request
-
import) from a clinician

1286 P3895 ZOLEDRONIC ACID ZOLEDRONIC ACID Injection 4mg Restricted for TA 07.11.2016 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

1287 P3367 ZOLMITRIPTAN Zolmitriptan Nasal Spray 2.5 mg/puff POM (Pre- TA 17.02.2015 - Product approved
authorization 31.07.2019 based on a
- required before special request
import) from a clinician

1288 P3368 ZOLMITRIPTAN Zolmitriptan Nasal Spray 5 mg/puff POM (Pre- TA 17.02.2015 - Product approved
authorization 31.07.2019 based on a
- required before special request
import) from a clinician

1289 P3365 ZOLMITRIPTAN Zolmitriptan Tablet 2.5 mg POM (Pre- TA 17.02.2015 - Product approved
authorization 31.07.2019 based on a
- required before special request
import) from a clinician

1290 P3366 ZOLMITRIPTAN Zolmitriptan Tablet 5 mg POM (Pre- TA 17.02.2015 - Product approved
- authorization 31.07.2019 based on a
required before special request
import) from a clinician
1291 P3279 ZOLPIDEM Zolpidem Tablet 5 mg CONTROLLED ( Pre- TA 10.02.2015 - Product approved
Authorization 31.07.2019 based on a
required before special request
-
import ) from a clinician

1292 P3280 ZOLPIDEM Zolpidem Tablet 10 mg CONTROLLED ( Pre- TA 10.02.2015 - Product approved
Authorization 31.07.2019 based on a
required before special request
-
import ) from a clinician

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 188 of 189 Authorized by:DG,MFDA
 1293 P3275 ZUCLOPENTHIXOL ACETATE Zuclopenthixol Acetate Injection 50 mg/ml Restricted for TA 10.02.2015 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

1294 P3276 ZUCLOPENTHIXOL ACETATE Zuclopenthixol Acetate Injection 100 mg/ 2 ml Restricted for TA 10.02.2015 - Product approved
Hospital use only (Pre- 31.07.2019 based on a
Authorization special request
-
required before from a clinician
import)

1.For the Products in this list where the formulation is mentioned, that specific formulation only can be imported
2.For those products in which the fomulation is not mentioned, the product imported should be of export quality and not specified for a specific market

MTG Division, MFDA Rec. Name: Approved Drug List

Rec. No.: MTG/RE-AL/Li 0009 Issued Date: 12/02/2018
Issue No.: 02 Rev.Date: 19.02.2019
Rev. No.: 02 Page 189 of 189 Authorized by:DG,MFDA