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SPECIAL ISSUE

THE KENYA GAZETTE Published by Authority of the Republic of Kenya

(Registered as a Newspaper at the G.P.O.)

Vol. CXIII—No. 9 NAIROBI, 21st January, 2011 Price Sh. 50

GAZETTE NOTICE NO. 744

THE PHARMACY AND POISONS ACT

(Cap. 244)

THE PHARMACY AND POISONS BOARD

IT IS notified that the following drugs have been registered in accordance with the provisions of the Pharmacy and Poisons Act and the Pharmacy and Poisons (Registration of Drugs) Rules, 1981.

REGISTERED DRUGS—10TH APRIL 2008 TO 31ST DECEMBER, 2009

Reg. Number Trade Name Dosage Form Active Ingredient(s) Manufacturer Date of

Registration

Anaesthetics

H2009/20469/483 Anasica Adrenaline 2%

Injection

Injection Lidocaine Hcl Bp 21.33mg,

Adrenaline Bp 0.0125mg Per Vial

Ambalal Sarabhai 4-Aug-09

H2009/20557/418 Atracade Injection Injection Atracurium Besylate Usp 10mg

Per Ml

Bharat Serums And Vaccines;

India

6-Aug-09

H2008/13291/758 Lidocaine &

Adrenaline Injection

Injection Lignocaine Hcl Bp 21.33mg,

Adrenaline 0.0125mg Per Ml

Lincoln Pharmaceuticals 7-Apr-09

H2009/14667/499 Medicaine Injection Injection Lidocaine Hydrochloride Usp 36

Mg Per 1.8ml, Epinephrine

Bitartrate Usp 0.0324 Mg

Equivalent To Epinephrine 0.018

Mg

Houns Co. Ltd 4-Aug-09

H2009/20853/510 Propofol Lipuro

Injection

Injection Propofol 10mg Per Ml B. Braun 6-Aug-09

H2009/20499/426 Sevoflurane Inhalation

Anaesthetic

Inhalation

Solution

Sevoflurane 250ml Per Bottle Piramal Healthcare 6-Aug-09

Analgesics Antipyretics, Nsaids

H2008/19874/840 Abumol Tablets Tablets Paracetamol Bp 325mg, Ibuprofen

Bp 400mg

Benmed Pharmacuticals Ltd 7-Apr-09

H2009/20458/694 Acepar Caplets Tablets Aceclofenac Bp 100mg,

Paracetamol Bp 500mg

Dawa Ltd 2-Dec-09

H2009/20319/447 Panadol Advance

Tablets

Tablets Paracetamol 500mg Glaxosmithkline Ltd 6-Aug-09

H2008/19700/721 Acexx Tablets Tablets Aceclofenac Bp 100mg Metro Pharmaceuticals

Manufactured By Unique

Remedies Ltd

7-Apr-09

H2008/18950/925 Admol – Mr Tablets Tablets Diclofenac Sodium Bp 50mg,

Paracetamol Bp 325mg,

Chlorzoxaxone Usp 250mg

Troikaa Pharmaceuticals Ltd;

India

7-Apr-09

H2009/19167/707 Adol Suppositories Suppository Paracetamol 500mg Gulf Pharmaceuticals Ltd 2-Dec-09

H2008/19158/419 Anadol Capsules Capsules Tramadol Hcl Bp 50 Mg Square Pharmaceuticals,

Bangladesh

7-Apr-09

[199

THE KENYA GAZETTE 21st January, 2011

200


Registration

H2009/20066/060 Apitac 100mg Tablets Tablets Aceclofenac 100mg Acme Laboratories Ltd; Dhaka,

Bangladesh

7-Apr-09

H2008/19840/877 Artifen Plus Tablets Tablets Ibuprofen Bp 400mg, Paracetamol

Bp 500mg

Aglowmed Ltd, 51, Raipur,

Roorkee, 247 661, India

7-Apr-09

H2009/19431/675 Asfen-400 Tablets Tablets Ibuprofen Bp 200mg Astra Lifecare 2-Dec-09

H2009/20198/261 Aspirin 300mg Tablets Tablets Aspirin Bp 300mg Shanxi Yabao Pharmaceutical

(Group) Co. Ltd; China

28-May-09

H2008/19805/843 Bencam 15mg Tablets Tablets Meloxicam Bp 15mg Benmed 7-Apr-09

H2008/19804/844 Bencam 7.5mg Tablets Tablets Meloxicam Bp 7.5mg Benmed 7-Apr-09

H2009/20650/460 Bettam 7.5mg Tablets Tablets Meloxicam 7.5mg Unison Laboratories Co., Ltd,

Thailand For Omaera

Pharmaceuticals Ltd ; Kenya

6-Aug-09

H2009/19380/324 Bio-Nac 50mg Tablets Tablets Diclofenac Sodium Bp 50mg Devang Pharmaceuticals Ltd 6-Aug-09

H2009/19509/116 Bio-Nac P Tablets Tablets Diclofenac Sodium Bp 50mg,


Devang Pharmaceuticals Ltd;

India

7-Apr-09

H2008/16075/420 Brumed 400mg

Tablets

Tablets Ibuprofen Bp 400mg Medreich Sterilab Ltd;

Medreich Hse # 12/8,

Saraswathi Ammal St, Maruthi

Sevanager, Bangalore – 560

033, India

7-Apr-09

H2008/19926/1003 Ceclonec 100mg

Tablets

Tablets Aceclofenac Bp 100mg Unicure Remedies Ltd 7-Apr-09

H2009/19961/639 Cetafen Dispersible

Tablets

Tablets Ibuprofen 100mg, Paracetamol

162.5mg

Sigma Pharmaceuticals 22-Sep-09

H2008/19406/553 Chap-Chap Caplets Tablets Aspirin Bp 400mg; Paracetamol

Bp 200mg; Caffeine Bp 50mg

Universal Corporation Ltd;

Kenya

7-Apr-09

H2008/19549/912 Clanza Tablets Tablets Aceclofenac 100mg Korea United Pharm. 7-Apr-09

H2008/18799/698 Clodol 100 Tablets Tablets Diclofenac Sodium Bp 100mg Mission Pharmaceuticals 7-Apr-09

H2009/18558/467 Clodol Injection Tablets Diclofenac Sodium Bp 25mg Per

Ml

Mission Pharmaceuticals Ltd,

3325, Gidc, Sarigam, Dist.

Valsad, Gujarat – 396 155, India

6-Aug-09

H2008/19362/699 Clof Tablets Tablets Aceclofenac Bp 100mg Biopharma 7-Apr-09

H2009/13015/157 Cosflam-50 Tablets Tablets Diclofenac Sodium Bp 50mg Cosmos Ltd; Kenya 7-Apr-09

H2008/19307/671 D-Fenac 100 Tablets Tablets Diclofenac Tablets Bp 100mg Zest Pharma 7-Apr-09

H2008/19306/672 D-Fenac 5o Tablets Tablets Diclofenac Tablets Bp 50mg Zest Pharma 7-Apr-09

H2009/18534/216 Dfenac Injection Injection Diclofenac Sodium Bp 25 Mg Per

5ml

Swiss Parenterals Pvt Ltd; India 28-May-09

H2008/13286/741 Diclofenac Sodium

Injection

Injection Diclofenac Sodium Bp 25mg Per

Ml

Lincoln Pharmaceuticals Ltd 7-Apr-09

H2009/19979/052 Diclofenac Sodium Sr

Tablets Bp

Tablets Diclofenac Sodium Bp 100mg Sanya Life Sciences, India;

Manufactured By Atra Pharma

Pvt. Ltd; India

7-Apr-09

H2008/19978/1038 Diclofenac Sodium

Tablets

Tablets Diclofenac Sodium Bp 50mg Sanya Life Sciences, India 7-Apr-09

H2008/19326/613 Diclogen Tablets Tablets Diclofenac Sodium Bp 100mg Agio Pharmaceuticals Ltd, A-38

Nandjyot Industrial Estate

Mumbai 400 072, India

7-Apr-09

H2009/15066/369 Dinac Plus Tablets Tablets Paracetamol Bp 500mg,

Diclofenac Sodium Bp 50mg

Universal Corporation Ltd 6-Aug-09

H2009/16096/062 Doloact 50mg Tablets Tablets Diclofenac Potassium Bp 50mg Ochoa Laboratories Ltd 7-Apr-09

H2009/20583/312 Dolviran Tablets Tablets Acetylsalicylic Acid 400mg,

Codeine Phosphate Hemihydrates

9.6mg, Caffeine 50mg

Bayer Schering Pharma 6-Aug-09

H2009/20447/454 Dynapar Aq Injection Injection Diclofenac Sodium Bp 75mg Per

Ampoule

Troikaa Pharmaceuticals Ltd;

India

6-Aug-09

H2009/21029/661 Effermol 1000mg

Tablets

Tablets Paracetamol Ph. Eur. 1000mg Cipla Ltd; India 1-Oct-09

H2008/13378/599 Elfenac Tablets Tablets Diclofenac Sodium Bp 50mg Elys Chemical Industries Ltd,

Idustrial Area, Nairobi

7-Apr-09

H2009/19595/700 Elymol Extra Tablets Tablets Paracetamol Bp 500mg, Caffeine Elys Chemical Industries 2-Dec-09

H2009/20433/424 Fbi 100mg Tablets Tablets Flurbiprofen Usp 100mg Medicraft Pharmaceuticals(Pvt)

Ltd

6-Aug-09

H2008/18355/881 Fenplus Suspension Oral

Suspension

Ibuprofen Bp 100mg, Paracetamol

Bp 120mg Per 5ml

Coral 7-Apr-09

H2009/19559/327 Flamifen 400mg

Tablets

Tablets Ibuprofen Bp 400mg Flamingo Pharmaceuticals 6-Aug-09

H2009/21040/662 Flexi 100mg Tablets Tablets Aceclofenac Bp 100mg Square Pharmaceuticals Ltd;

Bangladesh

1-Oct-09

H2009/21114/683 Gacet 1gm

Suppositories

Suppository Acetaminophen Usp 1gm Bliss Gvs Pharma Lts; India 2-Dec-09

H2009/21112/684 Gacet 500mg

Suppositories

Suppository Acetaminophen Usp 500mg Bliss Gvs Pharma Lts; India 2-Dec-09

H2009/19705/99 Gofen 400 Softgel

Capsules

Capsules Solubilized Ibuprofen Equivalent

To Ibuprofen 400mg

Mega Lifesciences Ltd 7-Apr-09

21st January, 2011 THE KENYA GAZETTE 201


Registration

H2008/15985/434 Ibex Capsules Capsules Ibuprofen Bp 200 Mg;

Paracetamol Bp 325 Mg; Caffeine

Bp 30 Mg

Medreich Sterilab Ltd 7-Apr-09

H2009/19526/173 Ibudafen Suspension Oral

Suspension

Ibuprofen Bp 100 Mg Per 5 Ml Essential Pharmaceutical 7-Apr-09

H2008/19346/384 Ibuflam 200 Mg

Tablets

Tablets Ibuprofen Bp 200 Mg Biodeal Laboratories Ltd;

Kenya

7-Apr-09

H2008/19469/486 Ibuflam 400 Mg

Tablets

Tablets Ibuprofen Bp 400 Mg Biodeal Laboratories Ltd;

Kenya

7-Apr-09

H2008/19971/902 Ibuflam Plus

Suspension

Oral

Suspension


Bp 125mg Per 5ml

Biodeal Laboratories, Kenya 7-Apr-09

H2009/19998/673 Ibupar Suspension Oral

Suspension

Ibuprofen 100mg; Paracetamol

120mg Per 5ml

Dawa 6-Oct-09

H2008/16480/833 Ibuplus Plus Tablets Tablets Ibuprofen Bp 400mg, Paracetamol

Bp 500mg

Leben Pharmaceuticals Ltd 7-Apr-09

H2008/19585/392 Ibuprofen Tablets

200mg

Tablets Ibuprofen 200 Mg Yongkang Ltd 7-Apr-09

H2008/19586/393 Ibuprofen Tablets

600mg

Tablets Ibuprofen 600mg Yongkang Ltd 7-Apr-09

H2009/20561/395 Iburoll 200mg Tablets Tablets Ibuprofen Bp 200mg Aurochem Lab Ltd; India For

Metro Pharmaceuticals Ltd

6-Aug-09

H2009/20562/396 Iburoll 400mg Tablets Tablets Ibuprofen Bp 400mg Aurochem Lab Ltd; India For


6-Aug-09

H2009/19588/520 Indomethacin 25mg

Capsules

Capsules Indomethacin Bp 25mg Yongkang 18-Aug-09

H2008/10376/1012 Indowin Capsules

25mg

Capsules Indomethacine Bp 25mg Caplin Point Laboratories 7-Apr-09

H2009/19973/558 Lysoflam Tablets Tablets Diclofenac 50mg, Paracetamol

500mg, Serratiopeptidase 15mg

Cachet 1-Sep-09

H2008/19704/760 Malvi 7.5mg Tablets Tablets Meloxicam Bp 7.5mg Metro Pharmaceuticals Ltd;

Manufactured By Unicure; India

7-Apr-09

H2009/20133/054 Mefa Capsules Capsules Mefenamic Acid 250mg Sichuan Kewa Pharmaceuticals,

China

7-Apr-09

H2008/19088/476 Mefan Cap 250 Mg

Capsules

Capsules Mefenamic Acid Bp 250 Mg Gracure Pharmaceuticals; India 7-Apr-09

H2008/19852/803 Mefex Tablets Tablets Mefenamic Acid Bp 500mg Neopharma, Abu Dhabi,Uae 7-Apr-09

H2009/20719/670 Melgesic 15mg Tablets Tablets Meloxicam 15mg Aegis Ltd 2-Dec-09

H2008/19334/676 Mel-Od 15 Tablets Tablets Meloxicam Bp 7.5mg Cadila Healthcare Ltd,

Ahmedabad 382 210, India

7-Apr-09

H2009/20246/201 Melonac-15 Tablets Tablets Meloxicam Bp 15mg Zest Pharma 7-Apr-09

H2009/20247/202 Melonac-7.5 Tablets Tablets Meloxicam Bp 7.5mg Zest Pharma 7-Apr-09

H2008/19142/657 Mofic-15 Tablets Tablets Meloxicam Bp 15mg Cure Quick Pharmaceuticals,

20/3, Hsidc,Karnal-132001

Haryana, India

7-Apr-09

H2008/19058/588 Movex 100mg Tablets Tablets Aceclofenac Bp 100mg Opsonin Pharma Limited,

Bangladesh

7-Apr-09

H2008/18997/377 Naloxone 0.4mg/Ml

Injection

Injection Naloxone Hcl Dihydrate 0.44 Mg

Equivalent To Naloxone Hcl 0.4

Mg Per Ml

Rotex Medica, 22946, Trittau,

Germany

7-Apr-09

H2008/19529/963 Nasida Sr Capsules Capsules Diclofenac Sodium Bp 100 Mg Delta Pharma Ltd; Kishoreganj;

Bangladesh

7-Apr-09

H2008/19451/815 Nelstan 500mg Caplets Tablets Mefenamic Acid 500mg Universal Corporation 7-Apr-09

H2009/19901/677 Nortem Oral

Suspension

Oral

Suspension


Bp 250mg Per 5ml

Torque Pharmaceuticals Ltd; 6-Oct-09

H2009/20649/624 Nurofen 200mg Tablets Tablets Ibuprofen 400mg Crookes; Uk For Reckitt

Benckiser

15-Sep-09

H2009/20322/332 Nysa Tablets Tablets Piroxicam Usp 20mg Getz Pharma 6-Aug-09

H2009/20144/566 Okagesic-200 Tablets Tablets Ibupfrofen Bp 200 Mg Okasa Pharma Pvt Ltd 1-Sep-09

H2009/20141/567 Okagesic-400 Tablets Tablets Ibuprofen Bp 400mg Okasa Pharma Pvt. Ltd 1-Sep-09

H2008/15396/423 Orchidol 50mg Tablets Tablets Tramadol Hcl 50 Mg Orchid Healthcare 7-Apr-09

H2008/20054/1050 Ossfen Suspension Oral

Suspension

Ibuprofen Bp 100mg Per 5ml Oss-Chemie (K) Ltd 7-Apr-09

H2009/20051/038 Ossmol Suspension Oral

Suspension

Paracetamol B.P 120mg Per 5ml Oss-Chemie (K) Ltd 7-Apr-09

H2009/20661/731 Parace Suspension Suspension Paracetamol Bp 125mg Zest Pharma 2-Dec-09

H2009/19587/524 Paracetamol Tablets Tablets Paracetamol Bp 500mg Yongkang 18-Aug-09

H2008/19106/534 Paracol Tablets Tablets Paracetamol Bp 500mg Pmc; Kenya For Essential;

Kenya

7-Apr-09

H2009/18549/249 Parafen Anal

Suppositories

Suppositories Paracetamol Bp 80mg, Ibuprofen

Bp 50mg

Gvs Bliss Pharma 28-May-09

H2008/20042/910 Pedifen Syrup Syrup Ibuprofen 100mg Per 5ml Dafra Pharma Ltd;

Manufactured By Atabay Ilac;

Koftuncu Sokak # 134 718,

Istanbul, Turkey

7-Apr-09


202


Registration

H2008/19005/948 Pharmamol 500 Mg

Tablets

Tablets Paracetamol Bp 500 Mg Hebei Jiheng 7-Apr-09

H2008/19394/891 Piroxicam Capsules Capsules Piroxicam 20mg Sishui Xierkang Ltd 7-Apr-09

H2008/19837/718 Pladazol Capsules Capsules Tramadol Hcl Bp 50mg

Equivalent To Tramadol Base

44.09mg

Plethico Pharmaceuticals Ltd,

Dharavara, Kalaria 453 001,

Indore (M.P.), India

7-Apr-09

H2009/19833/183 Plazadol Injection Injection Tramadol Base 44.09 Mg Per Ml Plethico Pharmaceuticals Ltd 7-Apr-09

H2008/17239/521 Powergesic Mr Tablets Tablets Diclofenac 50mg; Paracetamol

500mg; Chlorzoxazone Usp 50mg

Jenburkt Pharmaceuticals Ltd 7-Apr-09

H2009/20564/346 Powernoll Caplets Tablets Paracetamol Bp 500mg Metro Pharmaceuticals Ltd 7-Apr-09

H2008/16924/646 Profenazone Capsules Capsules Ibuprofen 200mg, Chlorzoxazone

250mg

Egyptian Co. For Chemicals

And Pharmaceuticals (Adwia);

Egypt

7-Apr-09

H2008/19834/720 Relievo Tablets Tablets Ibuprofen Bp 400mg, Paracetamol

Bp 325mg




7-Apr-09

H2008/19021/892 Rheumac-Sr Tablets Tablets Diclofenac Sodium Bp 100mg Laboratory & Allied; Kenya 7-Apr-09

H2009/20836/692 Rilif Mr Tablets Tablets Acecclofenac Bp 100mg,

Paracetamol Bp 500mg,

Chlorzoxazone Usp 375mg

Corona Remedies 2-Dec-09

H2009/20036/056 Rilif Plus Tablets Tablets Aceclofenac B.P 100mg,

Paracetamol B.P 500mg

Umedica Labs Pvt Ltd 7-Apr-09

H2009/20036/208 Rilif Plus Tablets Tablets Aceclofenac B.P

100mg,Paracetamol B.P 500mg

Umedica Labs Pvt Ltd 7-Apr-09

H2009/20037/106 Rilif Sr 200mg Tablets Tablets Aceclofenac Bp 200mg Umedica Laboratories Pvt Ltd 7-Apr-09

H2009/20671/354 Rolac 10 Injection Injection Ketorolac Tromethamine Usp

10mg

Renata 6-Aug-09

H2009/20669/654 Rolac 10 Tablets Tablets Ketorolac Tromethamine 10mg Renata Ltd 29-Sep-09

H2009/20672/355 Rolac 30 Injection Injection Ketorolac Tromethamine Usp

30mg

Renata 6-Aug-09

H2008/20084/945 Shift 100mg Tablets Tablets Aceclofenac Bp 100mg Zest Pharma, 275, Sector F,

Sanwer Road, Indore, 452015

(Mp), India

7-Apr-09

H2009/10875/078 Trasic Injection Injection Tramadol 100mg Per 2ml

Ampoule

Kopran 7-Apr-09

H2008/18924/1054 Trd-Contin 100 Tablets Tablets Tramadol Hcl Bp 100mg Modi-Mundipharma Pvt Ltd;

India

7-Apr-09

H2009/20385/477 Uxim 15 Mg Tablets Tablets Meloxicam Bp 15mg Universal Corporation 23-Jun-09

H2009/20384/478 Uxim 7.5 Mg Tablets Tablets Meloxicam Bp 7.5mg Universal Corporation 23-Jun-09

H2009/19727/257 Velcox 7.5mg Tablets Tablets Meloxicam 7.5mg Novell Pharmaceuticals, Bogor,

Indonesia

28-May-09

H2009/17595/631 Velredin 100mg

Tablets

Tablets Diclofenac Sodium B.P 100mg Prism Life Sciences 15-Sep-09

H2009/17594/632 Velredin 50mg Tablets Tablets Diclofenac Sodium B.P 50mg Prism Life Sciences 15-Sep-09

H2009/18695/250 Zerodol – P Tablets Tablets Aceclofenac Bp 100 Mg,

Paracetamol Bp 500 Mg

Ipca Laboratories Ltd 28-May-09

H2009/20532/294 Zerodol-Cr Tablets Tablets Aceclofenac Bp 200mg Ipca 28-May-09

H2008/19463/537 Zyrtal Mr Tablets Tablets Aceclofenac Bp 100mg;

Paracetamol Bp 500mg;

Chlorzoxazone Usp 500mg

Saga Laboratories; Plot 1409,

Phase Iii, G.I.D.C. Estate;

Vatwa, Ahmedbad, 382 445;

India

7-Apr-09

H2008/19464/523 Zyrtal Od Tablets Tablets Aceclofenac Bp 200 Mg Saga Laboratories; Plot 1409,



India

7-Apr-09

H2008/19465/524 Zyrtal Sp Tablets Tablets Aceclofenac Bp 100 Mg Saga Laboratories; Plot 1409,



India

7-Apr-09

Anti-Allergics & Drugs Used In Anaphylaxis

H2009/20789/417 Adco Cetirizine Tablets Tablets Cetirizine Dihydrochloride 10mg Adcock Ingram Ltd; South

Africa

6-Aug-09

H2008/19625/804 Adrenaline Injection Injection Adrenaline Hcl 1mg Per Ml Wuhan Grand For Yongkang 7-Apr-09

H2008/18891/828 Aireez 10 Mg Tablets Tablets Montelukast Sodium Eqiuvalent

To Montelukast 10 Mg

Pharmevo Pvt Ltd, Plot # A-29,

North Western, Industrial Zone,

Port Qasim, Karachi-75020,

Pakistan

7-Apr-09

H2008/18892/691 Aireez 5 Mg Tablets Tablets Montelukast Sodium Eqiuvalent

To Montelukast 5 Mg

Pharmevo Pvt Ltd 7-Apr-09

H2008/19164/506 Alatrol Syrup Syrup Cetirizine Dihydrochloride Bp

5mg Per 5ml

Square Pharmaceuticals Ltd.,

Pabna Unit, Salgaria, Pabna,

Bangladesh

7-Apr-09

H2009/20496/481 Alfree 10mg Tablets Tablets Cetirizine Dihydrochloride Bp

10mg

Stallion Laboratories Ltd; India 4-Aug-09



Registration

H2008/19422/426 Allergo 120mg Tablets Tablets Fexofenadine Hydrochloride 120

Mg

Agio Pharmaceuticals Ltd., At

T-82, M.I.D.C., Bhosari, Pune-

411026

7-Apr-09

H2008/19421/427 Allergo 180mg Tablets Tablets Fexofenadine Hydrochloride 180

Mg

Agio Pharmaceuticals Ltd., At

T-82, M.I.D.C., Bhosari, Pune-

411026

7-Apr-09

H2009/20697/637 Allerstat 120 Tablets Tablets Fexofenadine Hcl 120mg Cadila Pharmaceuticals 22-Sep-09

H2009/20696/638 Allerstat 180 Tablets Tablets Fexofenadine Hcl 180mg Cadila Pharmaceuticals 22-Sep-09

H2009/20225/370 Altrine 10mg Tablets Tablets Cetirizine Hcl Bp 10mg Universal Corporation Ltd; 6-Aug-09

H2009/20240/536 Altrine Syrup Syrup Cetirizine Hcl Bp 5mg Per 5ml Universal Corporation Ltd 1-Sep-09

H2009/16958/532 Alzine Oral Syrup Syrup Cetirizine Hcl Bp 5mg Per 5ml Sphinx Pharmaceuticals 27-Aug-09

H2009/18783/388 Brecare 10 Mg Tablets Tablets Montelukast Sodium Equivalent

To Montelukast Acid 5 Mg

Efroze Chemical Industries 6-Aug-09

H2009/18782/012 Brecare 5 Mg Tablets Tablets Montelukast Sodium Equivalent

To Montelukast Acid 5 Mg

Efroze Chemical Industries

(Pvt) Ltd, 146-147/23, Korangi,

Industrial Area, Karachi,

Pakistan

7-Apr-09

H2008/19812/687 Cerizine Tablets Tablets Levocetirizine 5mg Emcure 7-Apr-09

H2009/20810/541 Cetihis 10mg Tablets Tablets Cetirizine Dihydrochloride Bp

10mg

Unison Laboratories Co., Ltd,

Thailand For Omaera


1-Sep-09

H2008/18298/528 Cetriz-10 Tablets Tablets Cetirizine Hcl Bp 10mg Lab & Allied Ltd; Kenya 7-Apr-09

H2008/19015/580 Citin Tablets Tablets Cetirizine Hcl Bp 10mg Opsonin Pharma Limited,

Bangladesh

7-Apr-09

H2008/17744/581 Copazine Oral Solution Oral Solution Cetirizine Hyrochloride 5mg Per

Ml

Cosmos Ltd 7-Apr-09

H2008/17745/1060 Copazine Tablets Tablets Cetirizine Hyrochloride 10mg Cosmos Ltd 22-Apr-08

H2009/20588/408 Cortitab 10mg Tablets Tablets Hydrocortisone Usp 10mg Unicure Remedies For Metro

Pharmaceuticals Ltd

6-Aug-09

H2008/20105/981 Dawa-Prom Syrup Syrup Promethazine Bp 5mg Per 5ml Dawa Ltd 7-Apr-09

H2009/20352/300 Desodin Tablets Tablets Desloratadine 5mg Eskayef; Bangladesh 28-May-09

H2008/19325/956 D-Loratin Tablets Tablets Desloratadine 5mg Cipla Ltd, Plot No. 338/1-A,

Kachigam, Daman 396 210,

India

7-Apr-09

H2008/15913/525 Algyfree Plus Tablets Tablets Loratadine 10mg;

Pseudoephedrine Hydrochloride

180mg

Nic Pharma; India 7-Apr-09

H2009/20186/551 Ezi-Ride 12.5 Mg

Tablets

Tablets Meclizine Hcl Usp 12.5mg Unicure Remedies; India For


1-Sep-09

H2008/19783/662 Finallerg 10mg Tablets Tablets Cetirizine Hydrochloride 10mg Pharma International Co. Ltd,

Amman, Jordan

7-Apr-09

H2009/19644/025 Folerin 10mg Tablets Tablets Loratadine 10mg Novell Pharmaceutical

Laboratories, Bogor, Indonesia

7-Apr-09

H2009/20375/554 Gulair 10mg Tablets Tablets Montelukast 10mg National Company For

Pharmaceutical Industry

1-Sep-09

H2009/20377/555 Gulair 5mg Tablets Tablets Montelukast 5mg National Company For


1-Sep-09

H2008/13290/751 Hydrocortisone Sodium

Succinate Injection

Injection Hydrocortisone (As Sodium

Succinate) Bp100mg


H2009/20248/709 Irnazin 5mg Tablets Tablets Levocetirizine Dihydrochloride

5mg

Indus Pharma Ltd 2-Dec-09

H2009/19681/066 Letrizine Syrup Oral Syrup Levocetirizine Dihydrochloride

2.5mg Per 5ml

Cipla Ltd; India 7-Apr-09

H2009/20187/263 Levocez Tablets Tablets Levocetirizine 5mg Unicure For Metro

Pharmaceuticals Ltd

28-May-09

H2009/20045/277 Loractiv Tablets Tablets Loratadine Usp 10mg Plethico Pharmaceuticals 28-May-09

H2008/19368/572 Lorata Oral Solution Oral Solution Loratadine Usp 5 Mg Per 5ml Lab & Allied Ltd; Kenya 7-Apr-09

H2008/18297/532 Lorata-10 Tablets Tablets Loratadine Usp 10mg Lab & Allied Ltd; Kenya 7-Apr-09

H2008/19703/759 Lorix 10mg Tablets Tablets Loratadine Usp 10mg Metro Pharmaceuticals Ltd;

Manufactured By Unicure; India

7-Apr-09

H2008/18801/520 Micet Syrup Syrup Cetirizine Hcl Bp 5 Mg Per 5ml Mission Pharmaceuticals Ltd 7-Apr-09

H2009/18191/101 Montair 10 Tablets Tablets Montelukast Sodium Equivalent

To Montelukast 10mg


H2008/18192/395 Montair 5 Tablets Tablets Montelukast Sodium Equivalent

To Montelukast 5 Mg

Cipla Ltd 7-Apr-09

H2009/20363/207 Montene 10mg Tablets Tablets Montelukast 10mg Square Pharmaceuticals

Ltd;Bangladesh

7-Apr-09

H2008/19495/489 Montene 5 Mg Tablets Tablets Montelukast 5 Mg Square Pharmaceuticals Ltd;

Pabna Unit, Salgaria, Pabna;

Bangladesh

7-Apr-09

H2009/20693/500 Osscet Syrup Syrup Cetirizine Dihydrochloride Bp

5mg Per 5ml

Oss-Chemie Ltd 4-Aug-09

H2009/20053/039 Pirioss Syrup Syrup Chlorpheniramine Maleate B.P

4mg Per 10ml

Oss-Chemie (K) Ltd 7-Apr-09


204


Registration

H2009/20612/366 Prednimet 5mg Tablets Tablets Prednisolone Usp 5mg Unicure For Metro 6-Aug-09

H2008/19876/872 Sulid Tablets Tablets Cetirizine Hydrochloride Bp 10mg Benmed Pharmacuticals Ltd 7-Apr-09

H2008/19787/664 Tildor Syrup Syrup Loratadine 5mg Per 5ml Pharma International Co. Ltd,

Amman, Jordan

7-Apr-09

H2008/19786/665 Tildor Tablets Tablets Loratadine 10mg Pharma International Co. Ltd,

Amman, Jordan

7-Apr-09

H2009/20158/071 Triz Syrup Syrup Cetirizine Hcl Bp 5mg Per 5ml Indoco Remedies Ltd, India 7-Apr-09

H2009/20157/072 Triz Tablets Tablets Cetirizine Hcl Bp 10mg Indoco Remedies Ltd, India 7-Apr-09

H2009/18195/085 Ultigra 120 Tablets Tablets Fexofenadine Hydrochloride

120mg

Medley Pharmaceuticals 7-Apr-09

H2009/20031/350 Unizine Syrup Oral Syrup Cetirizine Hcl B.P 5.0mg Pharmaceutical Manufacturing

Co.

6-Aug-09

H2009/19743/505 Unizine Tablets Tablets Cetirizine Hcl Bp 10.0mg Pmc Ltd-Kenya 4-Aug-09

H2009/20712/508 Xenoxin 500mg

Tablets

Tablets Promethazine Hcl 25mg Eskayef Bangladesh Ltd 4-Aug-09

H2008/19798/690 Zocet 5 Tablets Tablets Levocetirizine Dihydrochloride

5mg

Agio Pharmaceuticals 7-Apr-09

Antidotes & Substances Used In Poisonings

H2009/20589/409 Charco Tablets Tablets Activated Charcoal Bp 250mg Unicure Remedies For Metro

Pharmaceuticals Ltd

6-Aug-09

Anti-Malarials

H2009/19776/480 Ago-Quinine Tablets Tablets Quinine Sulphate Bp 300 Mg Agog Pharma Ltd 4-Aug-09

H2008/17290/667 Alphaquine Suspension Oral

Suspension

Amodiaquine Hydrochloride

Equivalent To Amodiaquine 50

Mg Per 5ml

Dawa Pharmaceuticals Ltd 7-Apr-09

H2009/19518/079 Amonate Fdc Adult

Tablets

Tablets Artenusate 100 Mg, Amodiaquine

306.2 Mg (A Pack Of Six (6)

Tablets)

Dafra Pharma Ltd Manufactured

By Famar

7-Apr-09

H2009/19519/080 Amonate Fdc Infant

Tablets

Tablets Artenusate 100 Mg, Amodiaquine

306.2 Mg (A Pack Of Three (3)

Tablets)

Dafra Pharma Ltd Manufactured

By Famar

7-Apr-09

H2008/16670/607 Artefan 20/120 Tablets Tablets Artemether 20 Mg, Lumefatrine

120mg

Ajanta Pharma Limited 7-Apr-09

H2009/19674/124 Artefan 80/480mg

Tablets

Tablets Artemether 80mg, Lumefantrine

480mg

Ajanta Pharma Ltd; India 7-Apr-09

H2008/19342/668 Artefan Suspension Oral

Suspension

Artemether Ph. Int. 180 Mg,

Lumefantrine 1080 Mg Per 60 Ml

Ajanta Pharma Ltd; B-4/5/6,

Midc Area, Paithan 431 128,

India

7-Apr-09

H2009/20044/003 Artemal-M Injection Injection Artemether 80mg Per Ml Plethico Pharmaceuticals Ltd 7-Apr-09

H2008/20044/1033 Artemal-M Injection Injection Artemether 80mg Per Ml Plethico Pharmaceuticals Ltd 7-Apr-09

H2007/336 Artemal-S 50 Tablets Tablets Artesunate 50mg Plethico Pharmaceuticals 20-Jun-07

H2009/20078/356 Artemether &

Lumefantrine


120mg

S Kant Healthcare Ltd; 6-Aug-09

H2008/19358/1034 Artequick Tablets Tablets Artemisinin 62.5mg, Piperaquine

375mg

Artepharm Co. Ltd, China 7-Apr-09

H2008/18107/390 Artequin Paediatric

Oral Sachets

Oral Sachets Artesunate 50 Mg; Mefloquine

125 Mg Per 3 Stickspacks

Mepha, Switzerland 7-Apr-09

H2009/19741/081 Artesiane 40 Injection Injection Artemether 40mg Per Ml Rotex Medica 7-Apr-09

H2009/19563/004 Artheget Tablets Tablets Artemether 20mg, Lumefantrine

120mg

Getz Phama Ltd, 29-30/2,

Karachi, Pakistan

7-Apr-09

H2009/20018/399 Artimal Injection Injection ΑLPHA-ß ARTEETHER 150 MG

PER ML

INDI PHARMA PVT LTD;

INDIA

6-Aug-09

H2009/19881/391 Artrin Tablets Tablets Artemether 20 Mg, Lumefantrine

120 Mg

Medreich Limited; India 6-Aug-09

H2008/19120/737 Co-Arinate Fdc Adult

Tablets

Tablets Artesunate 200mg,

Sulfamethoxypyrazine 500mg,

Pyrimethamine 25mg

Famar Italia S.P.A.; Italy For

Dafra Pharma Ltd; Kenya

7-Apr-09

H2008/19221/738 Co-Arinate Fdc Junior

Tablets

Tablets Artesunate 100mg,

Sulfamethoxypyrazine 250mg,

Pyrimethamine 12.5mg

Famar Italia S.P.A.; Italy For

Dafra Pharma Ltd; Kenya

7-Apr-09

H2008/19407/931 Coartem Dispersible

Tablets


120mg

Novartis 7-Apr-09

H2008/19207/1006 Co-Artemax Tablets Tablets Dihydroartemisinin 40 Mg,

Piperaquine Phosphate 320 Mg

Gap S.A 7-Apr-09

H2009/19865/061 Co-Mether Ds Tablets Tablets Artemether 40mg, Lumefantrine

240mg

Helix Pharma Ltd 7-Apr-09

H2008/18233/612 Curaquine Syrup Syrup Quinine Hydrochloride Bp

Equivalent To Quinine Base

100mg Per 5ml

Regal Pharmaceuticals Ltd 7-Apr-09

H2008/18682/431 D-Codimol 10 Tablets Tablets Dihydrocodeine Tartrate Bp

10mg; Paracetamol Bp 500mg

Cosmos Ltd P.O Box 4143-

00100 Nairobi, Kenya

7-Apr-09

H2009/20252/198 Duo-Cotecxin Tablets Tablets Dihydroartemisinin 20 Mg,

Piperaquine Phosphate 160 Mg

Zhejiang Holley Nanhu

Pharmaceuticals Co. Ltd; China

7-Apr-09



Registration

H2009/20200/199 Duo-Malacur Tablets Tablets Dihydroartemisinin 40mg,

Piperaquine Phosphate 320mg

Shanxi Shuguang Pharma Co.

Ltd; China

7-Apr-09

H2009/20760/517 Duotab Tablets Tablets Dihydroartemisinin 40mg,

Piperaquine Phosphate 320mg

Universal Corporation 18-Aug-09

H2008/19072/808 Fantem-20/120 Tablets Tablets Artemether 20mg, Lumefantrine

120mg

Madras Pharmaceutical, For

Medinomics

7-Apr-09

H2009/20234/470 Hilact Injection 80mg Injection Artemether 80mg Per Ampoule Hilton Pharma 6-Aug-09

H2008/18714/585 Lonart – Ds Tablets Tablets Artemether 80mg, Lumefantrine

480mg

Gvs Bliss Pharma 7-Apr-09

H2008/18715/586 Lonart Forte Tablets Tablets Artemether 40mg, Lumefantrine

240mg

Gvs Bliss Pharma 7-Apr-09

H2009/20341/189 Lonart Suppositories Suppositories Artemether 20mg, Lumefantrine

120mg

Bliss Gvs Pharma Ltd 7-Apr-09

H2009/20643/398 Lufanate Suspension Oral

Suspension

Artemether 180 Mg, Lumefantrine

1080 Mg Per 60ml

Cosmos Limited 6-Aug-09

H2009/20040/100 Lufenart Tablets Tablets Artemether 20mg Lumefantrine

120mg

Umedica Laboratories Pvt Ltd 7-Apr-09

H2009/20716/652 Lumartem Tablets Tablets Artemether 20mg, Lumefantrine

120mg

Square Pharmaceuticals Ltd 29-Sep-09

H2009/18930/145 Lumether Tablets Tablets Artemether 20mg, Lumefantrine

120mg

Themis Medicare Limited 7-Apr-09

H2009/18057/714 Macsunate Fdc Tablets Tablets Artesunate 50mg, Amodiaquine

Hcl Usp 200mg Equivalent To

Amodiaquine Base 153.1mg

Macleods Pharmaceuticals Ltd 2-Dec-09

H2008/18555/890 P-Alaxin Suspension Oral

Suspension

Dihydroartemisinin 80mg,

Piperaquine Phosphate 640mg Per

5ml

Gvs Labs 7-Apr-09

H2009/18702/105 Quinine Injection Injection Quinine Dihydrochloride Bp

300mg Per Ml

Caplin Point Labs Ltd 7-Apr-09

H2008/18965/624 Quinine Sulphate

Tablets Bp 300mg

Tablets Quinine Sulphate Bp 300mg Intas Pharmaceuticals; India 7-Apr-09

H2008/18610/992 S-Quin Injection

300mg/Ml

Injection Quinine Dihydrochloride Bp

300mg Per Ml

Swiss Parenterals Pvt, Ltd 7-Apr-09

H2008/18612/993 Synchlor Injection Injection Chloroquine Phosphate Bp

Equivalent To Chloroquine Base

40mg Per Ml


Anti-Bacterials

H2008/19602/996 Acinet 1000mg Tablets Tablets Amoxicillin Trihydrate Usp

Equivalent To Amoxicillin

875mg, Clavulanate Potassium

Usp Equivalent To Clavulanic

Acid 125mg

Cachet Manufactured By Alkem

Laboratories Ltd; India

7-Apr-09





Acid 125mg



7-Apr-09





Acid 125mg



7-Apr-09

H2008/19603/732 Acinet Dry Syrup

228.5mg/5ml

Oral

Suspension

Amoxicillin Trihydrate Usp




Acid 28.5mg Per 5ml

Cachet Pharmaceuticals

Manufactured By Alkem

Laboratories Ltd, 167/1, Village

Dabhel, Daman-396 210, India

7-Apr-09

H2008/19605/666 Acinet Injection 1.2 G Injection Amoxicillin Sodium Bp

Equivalent To Amoxicillin 1 G,

Clavulanate Potassium Usp

Equivalent To Clavunalic Acid

200 Mg Per Vial

Cachet Pharmaceuticals Ltd;


Laboratories Ltd For Cachet

Pharmaceuticals Ltd At, 167/1

Village Dabhel Daman, 396 210

India

7-Apr-09

H2009/19419/001 Agilevo 500 Mg

Tablets

Tablets Levofloxacin Hemihydrate

Equivalent To Levofloxcin 500

Mg

Agop Pharmaceuticals Ltda-38

Nandiyot Industrial Estate,

Kurla-Anderi Road, Safepool,

Mumbai- 400 072 India

7-Apr-09

H2009/17821/535 Alimox Dry Syrup Syrup Amoxicillin 125 Per 5ml Sphinx Pharmaceuticals 1-Sep-09

H2008/19535/1031 Alzicon 1 Gm Injection Injection Ceftriaxone Sodium Usp

Equivalent To Ceftriaxone 1gm

Alembic Ltd; Alembic Rd,

Vododara 390 003, India

7-Apr-09

H2008/19557/693 Amoxicillin Sodium

And Clavulanate

Potassium 1.2gm

Injection

Injection Amoxicillin As Sodium Salt 1g,

Clavulanic Acid 0.2g As

Potassium Salt

Sichuan Pharmaceuticals 7-Apr-09


206


Registration

H2008/19556/694 Amoxicillin Sodium

And Clavulanate

Potassium 600mg

Injection

Injection Amoxicillin As Sodium Salt 0.5g,

Clavulanic Acid 0.1g As

Potassium Salt


H2009/18958/002 Amoxi-Denk 1000

Chewable Tablets

Tablets Amoxicillin Trihydrate Equivalent

To Amoxicillin 1000mg

Cimex Ag Pharamzeutika,

Birsweg 2 4253 Lieberg,

Switzerland For Denk Pharma

Gmbh & Co. Kg

Prinzregentenstr. 79, 81675

Muenchen, Germany

7-Apr-09

H2008/19896/911 Ampicillin 250 Mg

Injection B.P

Injection Ampicillin 250 Mg Per Vial Gracure Pharmaceuticals 7-Apr-09

H2009/18982/537 Ampiclodawa 500 Mg

Capsules

Capsules Ampicillin Trihydrate Equivalent

To Ampicillin 250 Mg,

Cloxacillin Sodium Equivalent To

Cloxacillin 250 Mg

Dawa Pharmaceuticals 1-Sep-09

H2009/18906/142 Ampiclo-Dawa Powder

For Oral Suspension

Oral

Suspension

Ampicillin 125 Mg, Cloxacillin

125 Mg Per 5ml

Dawa Ltd; Kenya 7-Apr-09

H2009//677 Astiba-500 Tablets Tablets Tinidazole Bp 500mg Astra Lifecare 2-Dec-09

H2009/20159/400 Atm 200 Suspension Oral

Suspension

Azithromycin 200mg As The

Dihydrate Per 5ml

Indoco Remedies Ltd, India 6-Aug-09

H2008/19365/926 Augmenta 625 Tablets Tablets Amoxicillin 500mg, Clavulanic

Acid 125mg

Asia Pharmaceutical Industries

Aleppo, Syria

7-Apr-09

H2009/19554/005 Augmex 625mg

Tablets

Tablets Amoxicillin Trihydrate Equivalent

To Amoxicillin 500mg, Potassium

Clavulanate Equivalent To

Clavulanic Acid 125mg

Korea United Pharm. Inc; 404-

10, Nojang-Myeon, Yeongi,

Chungnam, Korea

7-Apr-09

H2009/19555/006 Augmex Duo Tablets Tablets Amoxicillin Trihydrate Equivalent




Korea United Pharm. Inc; 404-

10, Nojang-Myeon, Yeongi,

Chungnam, Korea

7-Apr-09

H2009/20449/486 Augmok 625mg

Tablets

Tablets Amoxicillin Trihydrate Usp

Equivalent To Amoxicillin 500

Mg, Clavulanate Potassium Usp

Equivalent To Clavulanic Acid

125 Mg

Shapaco Pharmaceutical Ind;

Yemen

4-Aug-09

H2008/18506/464 Auropennz 1.5 Gm

Injection

Injection Ampicillin Sodium Usp

Equivalent To Ampicillin 1.0

Gm; Sulbactam Sodium Usp

Equivalent To Sulbactam 0.5 Gm

Per Vial

Aurobindo Pharma Ltd; Plot

No.2, Maitrivihar, Ameerpet,

Hyderabad-500 038. India

7-Apr-09

H2008/18594/509 Auropenzz 3.0

Injection

Injection Ampicillin Usp 2.0 Gm;

Sulbactam 1.0 Gm Per Vial




7-Apr-09

H2008/18507/465 Aurozil 250mg/5ml

Suspension

Oral

Suspension

Cefprozil H2o Equivalent To

Anhydrous Cefprozil 250 Mg Per

5ml




7-Apr-09

H2009/19745/718 Azar-500 Tablets Azithromycin Anhydrous 500mg Ochoa Laboratory Ltd 2-Dec-09

H2009/19537/738 Azi – Bio Tablets Tablets Azithromycin U.S.P 500 Mg Devang Pharmaceuticals Pvt Ltd 2-Dec-09

H2008/19116/441 Aziagio 500 Tablets Tablets Azithromycin Usp Equivalent To

Azithromycin Anhydrous 500mg

Agio Pharmaceuticals Ltd, India 7-Apr-09

H2009/18656/538 Aziben-250 Tablets Tablets Azithromycin Usp As Dihydrate

Equivalent To Azithromycin

Anhydrous 250mg

Bentley And Remington 1-Sep-09

H2009/19053/007 Azicin 200mg/5ml

Suspension

Oral

Suspension

Azithromycin Dihydrate Usp


200mg Per 5ml

Opsonin Pharma Limited,

Bangladesh

7-Apr-09

H2008/19008/927 Azicin 500 Tablets Tablets Azithromycin 500mg Opsonin Pharma Limited,

Bangladesh

7-Apr-09

H2009/19053/125 Azicin Suspension Oral

Suspension



200mg Per 5ml

Opsonin Pharma Limited 7-Apr-09

H2009/20530/539 Azifast-500 Tablets Tablets Azithromycin Usp 500mg Ipca 1-Sep-09

H2009/20067/143 Azin Oral Suspension Oral

Suspension

Azithromycin Usp 200mg Per 5ml Acme Laboratories Ltd, Dhaka,

Bangladesh

7-Apr-09

H2009/19635/008 Azipar-500mg Tablets Tablets Azithromycin Bp Equivalent To

Anhydrous Azithromycin 500mg

Plethico Pharmaceuticals Ltd;

Dharavara, Kalaria, 453 001,


7-Apr-09

H2008/18948/928 Azithral Injection Injection Azithromycin Dihydrate Usp

Equivalent To Azithromycin Base

500mg Per Vial

Alembic Limited G/17-1, Midc,

Tarapur Industrial Estate,

Boisar, Thane-401 506, India

7-Apr-09

H2008/16199/391 Azithral Liquid 15ml Oral

Suspension

Azithramycin Dihydrate Usp

Equivalent To Azithromycin 40

Mg/Ml

Alembic Ltd 7-Apr-09



Registration

H2009/19886/457 Aztreonam 2gm

Injection

Injection Aztreonam Usp Equivalent To

Aztreonam 2gm Per Vial

Venus Remedies Ltd; India 6-Aug-09

H2009/19885/487 Aztreonam 500mg

Injection

Injection Aztreonam Usp Equivalent To

Aztreonam 500mg Per Vial


H2008/19846/1036 Bactrid Ee Tablets Tablets Amoxicillin Trihydrate Usp




Acid 62.5mg

Nexgen Healthcare Pvt Ltd,

Mumbai, India

7-Apr-09

H2009/18266/009 Benzathine

Benzylpenicillin

Injection 2.4 Mega

Injection Benzathine Benzylpenicillin Bp

2,400,000 Iu Per Vial

Sinochem Ningbo Ltd; China 7-Apr-09

H2008/19810/845 Benzathine Penicillin

2.4mega Injection

Injection Benzathine Penicillin 2.4 Mu Gracure Ltd 7-Apr-09

H2008/16313/491 Benzylpenicillin

Injection Bp 1m I.U.

Injection Benzyl Penicillin Sodium Bp

Equivalent To Benzyl Penicillin

1,000,000 Units (600mg) Per Vial

Nestor Pharmaceuticals Ltd;

India

7-Apr-09


Sodium Bp Injection

Injection Benzylpenicillin 5000000iu Per

Vial

Caplin Point Laboratories Ltd 7-Apr-09


Sodium Injection B.P.

1,000,000 Iu

Injection Benzyl Penicillin Sodium Bp

Equivalent To Benzyl Penicillin,

1,000,000 Iu

Ningoshuagwei Pharmaceuticals

Co. Ltd; China

7-Apr-09

H2009/11063/540 Broadimox 500mg

Capsules

Capsules Amoxicillin Trihydrate Bp

Equivalent Amoxicillin 500mg

Alkem Laboratories 1-Sep-09

H2008/18566/639 Cadiprim Suspension Oral

Suspension

Trimethroprim B.P. 40mg,

Sulphamethoxazole B.P 200mg

Per 5ml

Cadila Pharmaceuticals Ltd;

India

7-Apr-09

H2008/19600/527 Canem 1gm Injection Injection Meropenem B.P 1gm Cachet Manufactured By Alkem


7-Apr-09

H2008/19752/649 Canem 500 Injection Injection Meropenem Trihydrate Usp

500mg

Cachet Pharma. Ltd


Pharmaceuticals Ltd For Cachet

Pharma-India

7-Apr-09

H2008/18819/579 Cebactum 1500

Injection

Injection Ceftriaxone Sodium Usp

Equivalent To Ceftriaxone 1g,

Sulbactum Sodium Usp

Equivalent To Sulbactum 500mg

Per Vial

Leben Laboratories Pvt. Ltd. 7-Apr-09

H2008/17559/492 Cefasyn – 500 Tablets Tablets Cefuroxine Axetil Usp

Cefuroxime 500 Mg


H2008/19536/901 Cefatal 1 Gm Injection Injection Cefotaxime Sodium Ip Equivalent

To Cefotaxime 1gm

Alembic Ltd 7-Apr-09

H2009/20619/703 Cefclor-500 Capsules Capsules Cefaclor Usp 500mg Gracure Pharmaceuticals Ltd 2-Dec-09

H2009/20408/489 Cefdisun 1gm Injection Injection Ceftazidime 1gm Per Vial Suzhou Dawnrays

Pharmaceutical Co. Ltd; China

4-Aug-09

H2009/20406/490 Cefdisun 2gm Injection Injection Ceftazidime 2gm Suzhou Dawnrays


4-Aug-09

H2009/19444/017 Ceficad 1000 Injection Injection Cefepime Hcl Usp Equivalent To

Cefepime 1000mg Per Vial

Cadila Pharmaceuticals, 1389

Dholka-387 810, India

7-Apr-09

H2009/19443/018 Ceficad 2000 Injection Injection Cefepime Hcl Usp Equivalent To

Cefepime 2000mg Per Vial

Cadila Pharmaceuticals, 1389

Dholka-387 810, India

7-Apr-09

H2009/20373/450 Cefinir 300mg

Capsules

Capsules Cefdinir 300mg National Co. For

Pharmaceutical; Syria

6-Aug-09

H2008/19785/929 Cefix 100mg Oral

Suspension

Oral

Suspension

Cefixime Trihydrate Equivalent

To Cefixime 100mg Per 5ml

Pharma International Co. Ltd,

Amman, Jordan

7-Apr-09

H2009/19784/195 Cefix 200mg Capsules Capsules Cefixime Trihydrate Equivalent

To Cefixime 200mg

Pharma International Co. Ltd

Amman, Jordan

7-Apr-09

H2009/19807/260 Ceflorex Dry Syrup Syrup Cefixime Trihydrate Usp 100mg

Per 5ml

Saga Laboratories 28-May-09

H2009/20657/687 Cefoprox-200 Tablets Tablets Cefpodoxine Proxetil Usp

Equivalent To 200mg

Cefpodoxime

Cipla Ltd 2-Dec-09

H2009/20717/491 Cefotil 750mg Injection Injection Cefuroxime Injection Bp 750mg

Per Vial

Square Pharmaceuticals Ltd;

Bangladesh

4-Aug-09

H2009/20409/492 Cefpisun 1gm Injection Injection Cefepime Hydrochloride

Equivalent To Cefepime 1gm Per

Vial

Suzhou Dawnrays


4-Aug-09

H2008/18676/736 Ceftra 1000 Injection Injection Ceftriaxone Sodium U.S.P

Equivalent To Anhydrous

Ceftriaxone 1 G

Cipla Ltd L-2, Additional Area,

Satara 415 004 M.S India

7-Apr-09

H2009/20360/292 Ceftron 1 Gm Injection Injection Ceftriaxone Usp 1 Gm Square Pharmaceuticals Ltd;

Bangladesh

28-May-09

H2009/20397/428 Ceftrxsun 1.0 G

Injection

Injection Anhydrous Ceftriaxone 1.0 G Per

Vial

Sichuan Pharmaceuticals Inc 6-Aug-09


208


Registration

H2009/20396/427 Ceftrxsun 2.0 G

Injection

Injection Anhydrous Ceftriaxone 2.0 G Per

Vial

Sichuan Pharmaceuticals Inc 6-Aug-09

H2008/19558/697 Cefuroxime Sodium

0.75gm Injection

Injection Cefuroxime Sodium Equivalent

To Cefuroxime 0.75gm


H2009/20860/681 Cefuxime 1500 I.V For

Injection B.P

Injection Cefuroxime 1500mg Aurobindo Pharma Ltd 2-Dec-09

H2009/19069/384 Cefuxime 750 Injection Injection Cefuroxime Sodium Ph. Eur.

Equivalent To Cefuroxime 750mg

Per Vial

Aurobindo Pharma Ltd; India 6-Aug-09

H2009/20410/493 Cefxisun 1gm Injection Injection Cefotaxime Sodium Equivalent To

Cefotaxime 1gm Per Vial

Suzhou Dawnrays


4-Aug-09

H2009/20407/494 Cefxisun 2gm Injection Injection Cefotaxime Sodium Equivalent To

Cefotaxime 2gm Per Vial

Suzhou Dawnrays

Pharmaceutical

4-Aug-09

H2009/18421/019 Cepodem 100 Tablets Tablets Cefpodoxime 100 Mg Ranbaxy Laboratories Limited 7-Apr-09

H2009/18421/155 Cepodem 100 Tablets Tablets Cefpodoxime Proxetil Equivalent

To Cefpodoxime 100 Mg

Ranbaxy Laboratories Ltd 7-Apr-09

H2009/18422/020 Cepodem 200 Tablets Tablets Cefpodoxime 200 Mg Ranbaxy Laboratories Limited 7-Apr-09

H2009/18422/156 Cepodem 200 Tablets Tablets Cefpodoxime Proxetil Equivalent

To Cefpodoxime 200 Mg

Ranbaxy Laboratories Ltd 7-Apr-09

H2008/18416/442 Cetazime 1gm Injection Injection Ceftazidizime 5h2o/ Sodium

Carbonate Mixture 1.283 Gm

Equivalent To Ceftazidime 1 Gm

Per Vial

T3a Industrial; Egypt 7-Apr-09

H2008/18088/569 Chloramphenicol

Sodium Succinate

Injection

Injection Chloramphenicol Sodium

Succinate Bp Equivalent To

Chloramphenicol 1gm Per Vial

Macleods Pharmaceuticals Ltd;

India

7-Apr-09

H2009/19632/021 Cibid-500mg Tablets Tablets Ciprofloxacin Hcl 500mg Plethico Pharmaceuticals Ltd;

Dharavara, Kalaria, 453 001,


7-Apr-09

H2009/18987/394 Cifomed 250mg

Tablets

Tablets Ciprofloxacin 250 Mg Aglowmed Ltd 6-Aug-09

H2008/19100/611 Cipad 500 Tablets Tablets Ciprofloxacin Hcl Usp Equivalent

To Ciprofloxacin 500mg

Albert David Ltd., 5/11 D.Gupta

Lane, Kolkata 700 050, India

7-Apr-09

H2008/19101/669 Cipad Injection Injection Ciprofloxacin Usp 200mg Per

100ml

Albert David Ltd., B-12-13,

Meerut Road Industrial Area,

Ghaziabad U.P. 201 003, India

7-Apr-09

H2009/20093/688 Cipclav 1000 Tablets Tablets Amoxycillin 875mg, Clavulanic

Acid 125mg

Cipla Ltd 2-Dec-09

H2009/19402/542 Ciplin Ds Tablets Tablets Sulphamethoxazole B.P 800 Mg,

Trimethoprim B.P 160 Mg

Cipla Ltd; India 1-Sep-09

H2009/19401/397 Ciplin Suspension Oral

Suspension

Trimethoprim U.S.P 40 Mg,

Sulfamethoxazole U.S.P 200 Mg

Per Vial

Cipla Ltd; India 6-Aug-09

H2009/19399/543 Ciplin Tablets Tablets Trimethoprim B.P 80 Mg,

Sulfamethoxazole B.P 400 Mg

Cipla Ltd 1-Sep-09

H2008/19763/784 Ciprodeal Tablets Tablets Ciprofloxacin Bp 500mg Biodeal Labs Ltd 7-Apr-09

H2008/19611/785 Ciprofloxacin 250mg

Tablets

Tablets Ciprofloxacin Hcl Usp Equivalent


Umedica Laboratories Pvt. Ltd.,

Plot No. 221, G.I.D.C., Vapi-

396 195, Gujarat, India

7-Apr-09

H2008/19392/930 Ciprofloxacin 500mg

Tablets

Tablets Ciprofloxacin Hcl 500mg Sishui Xierkang Pharm Ltd;

China

7-Apr-09

H2009/20837/704 Cipromed-500 Tablets Tablets Ciprofloxacin Usp 500mg Gracure Pharmaceuticals Ltd 2-Dec-09

H2008/19187/554 Ciproriv Tablets Tablets Ciprofloxacin Hcl 500mg Riva Pharma Sae, Free Zone

Nasr City Cairo, Egypt

7-Apr-09

H2009/19290/022 Ciprost 500mg Tablets Tablets Ciprofloxacin Hcl Usp Equivalent


Sterling Lab; India 7-Apr-09

H2008/19386/404 Clamoxe 1000 Tablets Tablets Amoxicillin 875mg; Clavulanic

Acid 125mg

National Company For


Aleppo, Syria

7-Apr-09

H2008/19384/405 Clamoxe 457mg/5ml

Suspension

Oral

Suspension

Amoxicillin Trihydrate Equivalent

To Amoxicillin 400mg;

Clavulanic Acid 57mg Per 5 Ml



Aleppo, Syria

7-Apr-09

H2008/19385/406 Clamoxe 625 Tablets Tablets Amoxicillin 500mg; Clavulanic

Acid 125mg



Aleppo, Syria

7-Apr-09

H2008/18198/670 Clamycef Capsules Capsules Clindamycin Hydrochloride Usp

150mg

Unimed Pharmaceuticals Int.Ltd 7-Apr-09

H2009/20064/640 Claneksi 1.2 G I.V

Injection

Injection Amoxicillin B.P 1g, Clavulanic

Acid U.S.P 200 Mg Per Vial

Pt Sanbe Farma 22-Sep-09

H2008/18272/512 Claricos 125

Suspension

Oral

Suspension

Clarithromycin Usp 125mg Per

5ml

Cosmos Ltd; Kenya 7-Apr-09

H2009/19825/647 Clarie Ds 125mg/5ml

Suspension

Oral

Suspension


5ml

Ind-Swift Ltd; India 29-Sep-09



Registration

H2009/19824/648 Clarie Ds 250mg/5ml

Suspension

Oral

Suspension


5ml

Ind-Swift Ltd; India 29-Sep-09

H2009/20125/196 Clavulin 1gm Tablets Tablets Amoxicillin Trihydrate Equivalent




Glaxosmithkline 7-Apr-09

H2009/19964/197 Clavulin 457mg/5ml

Suspension

Oral

Suspension




Clavulanic Acid 57mg Per 5 Ml

Glaxosmithkline 7-Apr-09

H2009/20135/740 Clavulin 600mg

Injection

Injection Amoxicillin As Amoxicillin

Sodium 500mg, Clavulanic Acid

As The Potassium Salt 100mg Per

Vial

Glaxosmithkline 2-Dec-09

H2009/20136/741 Clavulin 1000mg

Injection

Injection Amoxicillin As Amoxicillin

Sodium 1000mg, Clavulanic Acid

As The Potassium Salt 200mg Per

Vial

Glaxosmithkline 2-Dec-09

H2009/17676/544 Claxy 375mg Tablets Tablets Amoxicillin Trihydrate Bp


250mg; Clavulanate Potassium


Acid 125mg

Swiss Parenterals 1-Sep-09

H2008/18455/979 Claxy-156.25

Suspension

Oral

Suspension


To Amoxicillin 125mg,

Clavulanic Acid 31.25mg


H2009/20061/620 Clincin Injection Injection Clindamycin Phosphate 150mg

Per Ml

Indi Pharma Pvt. Ltd 15-Sep-09

H2008/19965/1005 Cloxacillin Sodium

250mg Injection

Injection Cloxacillin 250 Mg Per Vial Gracure Pharmaceuticals 7-Apr-09

H2009/20236/736 Cloxam Dry Syrup Oral

Suspension

Cloxacillin 125 Mg Per Ml Sphinx Pharmaceuticals Ltd 2-Dec-09

H2008/18870/850 Combizol Tablets Tablets Ofloxacin Usp 200mg, Ornidazole

500mg

Zest Pharma Ltd 7-Apr-09

H2009/20680/512 Cotrimoxazole Tablets Tablets Trimethoprim Bp 80mg,

Sulfamethoxazole 400mg

Macleods 18-Aug-09

H2008/18665/493 Cotrimoxazole Tablets Tablets Trimethoprim Bp 80mg;

Sulfamethoxazole Bp 400mg

Mission Pharmaceuticals Ltd;

India

7-Apr-09

H2009/18833/128 Co-Trimoxazole

Tablets

Tablets Trimethorprim Bp 80mg,

Sulfamethoxazole Bp 400mg

Elys Chemical Industries Ltd;

Kenya

7-Apr-09

H2009/19908/696 Dawaphenicol 250

Capsules

Capsules Chloramphenicol 250mg Dawa Ltd 2-Dec-09

H2008/18983/831 Dawaphenicol

Suspension

Oral

Suspension

Chloramphenicol (As Palmitate)

Bp 125mg Per 5ml

Dawa Ltd 7-Apr-09

H2009/18275/496 Doxcef – 100 Tablets Tablets Cefpodoxime Proxetil Usp

Equivalent To Cefpodoxime 100

Mg

Lupin Ltd 4-Aug-09

H2008/19393/934 Doxycycline Hyclate

Capsules

Capsules Doxycycline Hyclate 100mg Sishui Xierkang Pharm Ltd;

China

7-Apr-09

H2008/18511/432 Drox 250 Suspension

B.P

Oral

Suspension

Cefadroxil Monohydrate B.P


Cefadroxil 250 Mg Per 5 Ml

Aurobindo Pharma Ltd 7-Apr-09

H2008/18650/744 Emdrox 125

Suspension

Oral

Suspension

Cefadroxil Usp Equivalent To

Anhydrous Cefadroxil 125mg Per

5ml

Medopharm 7-Apr-09

H2008/18074/616 E-Moxclav 1gm

Tablets

Tablets Amoxicillin (As Trihydrate)

875mg, Clavulanic Acid (As

Potassium Salt) 125mg

E. I. P. Co. Ltd 7-Apr-09

H2008/8839/746 Erythromycin Stearate

Tablets

Tablets Erythromycin (As Stearate)

250mg


H2009/18773/063 Evofix 100 Mg/5ml

Suspension

Oral

Suspension

Cefixime Usp 100 Mg Per 5 Ml Pharma Evo (Pvt) Ltd, Plot # A-

29, North Western, Pakistan

7-Apr-09

H2009/19460/406 Evorox 750 Mg

Injection

Injection Cefuroxime Sodium Equivalent

To Cefuroxime Usp 750 Mg Per

Vial

Pharmevo (Pvt) Ltd; Pakistan 6-Aug-09

H2009/18585/670 Extacef 100dt Tablets Tablets Cefixime Usp As Trihydrate


Cefixime 100mg

Blue Cross Laboratories 6-Oct-09

H2009/20376/552 Flamoxine 500mg

Capsules

Capsules Amoxicillin 250mg, Flucloxacillin

250mg



1-Sep-09

H2009/18157/251 Fleming Suspension Oral

Suspension

Amoxicillin Trihydrate Bp


400mg, Clavulanic Acid 57mg As

The Potassium Salt Per 5ml

Medreich Ltd 28-May-09


210


Registration

H2008/19725/1011 Flubiotic-500mg

Capsules

Capsules Flucloxacillin Bp 500mg Navana Pharmaceuticals 7-Apr-09

H2008/19725/1041 Flubiotic-500mg

Capsules

Capsules Flucloxacillin Bp 500mg Navana Pharmaceuticals 7-Apr-09

H2008/19115/444 Flucaz Capsules Capsules Fluconazole Usp 200mg Agio Pharmaceuticals Ltd, India 7-Apr-09

H2008/18749/468 Flucloxacillin 250 Mg

Capsules

Capsules Flucloxacillin Sodium Bp Equiv

To Flucloxacillin 250 Mg

Alkem Laboratories 167/1,

Village Dabhel, 396 210 India

7-Apr-09

H2009/20524/671 Flucloxin 250 Mg

Capsules

Capsules Flucloxacillin Base 250mg Eskayef Bangladesh Ltd 6-Oct-09

H2009/20525/672 Flucloxin 500 Mg

Capsules

Capsules Flucloxacillin Base 500mg Eskayef Bangladesh Ltd 6-Oct-09

H2008/19012/674 Flux 500 Capsules Capsules Flucloxacillin 500mg Opsonin 7-Apr-09

H2009/21041/724 Genacyn 80mg

Injection

Injection Gentamicin Sulfate Equivalent To

Gentamicin Bp 80mg

Square Pharmaceuticals Ltd 2-Dec-09

H2008/14425/530 Gentamicin Injection

Bp

Injection Gentamicin (As Sulphate) Bp

200,000 Units Equivalent To

Gentamicin Base 20mg

Lab & Allied Ltd; Kenya 7-Apr-09

H2009/19131/674 Hibiotic-N 1gm Tablets Tablets Amoxicillin Trihydrate Equivalent




Amoun Pharmaceuticals Co. 2-Dec-09

H2008/19074/938 Icef – Ds Suspension Oral

Suspension

Cefixime Usp 200 Mg Per 5ml Ici Pakistan Ltd, Life Sciences

Business Pharmaceuticals

Division 5 West Wharf,

Karachi, 74000 Pakistan

7-Apr-09

H2008/19076/939 Icef Capsules Tablets Cefixime Usp 400 Mg Ici Pakistan Ltd, Life Sciences

Business Pharmaceuticals

Division 5 West Wharf,

Karachi, 74000 Pakistan

7-Apr-09

H2009/20498/461 Imbac Iv Injection Injection Imipenem 500 Mg, Cilastatin 500

Mg Per Vial

Popular Pharmaceuticals Ltd;

Bangladesh

6-Aug-09

H2009/19888/601 Immunox – V 1.5gm

Injection

Injection Anhydrous Ceftriaxone 1g;

Vancomycin 0.5 G Per Vial

Venus Remedies Limited; India 8-Sep-09

H2008/18410/422 Indclav 156mg/5 Ml

Suspension

Oral

Suspension

Amoxicillin Trihydrate Usp

Equivalent To Amoxicillin 125

Mg; Clavulanate Potassium Usp

Equivalent To Clavulanic Acid

31.25 Mg Per 5 Ml

Indchemie Health Specialities

Pvt

7-Apr-09

H2008/19596/1013 Indpro-500 Tablets Tablets Ciprofloxacin 500mg Ind-Swift 7-Apr-09

H2009/17002/402 Infrid 750 Mg I.M.I.V

Injection

Injection Cefuroxime Sodium U.S.P 750

Mg Per Vial

Medicraft Pharmaceuticals(Pvt)

Ltd

6-Aug-09

H2008/18791/752 Ixime 400 Tablets Tablets Cefixime Usp Equivalent To

Anhydrous Cefixime 400mg

Lupin Ltd., 198-202, New

Industrial Area No. 2,

Mandideep-462 046, Dist.

Raisen (M.P.) India

7-Apr-09

H2008/18792/1016 Ixime Powder For Oral

Suspension

Oral

Suspension

Anydrous Cefixime 100 Mg Per

5ml

Lupin Ltd 7-Apr-09

H2008/14387/1017 Kanamycin Injection

Bp

Injection Kanamycin Sulphate Bp 1.0 Gm

Per Vial

Gracure Pharmaceuticals 7-Apr-09

H2008/18347/754 Kefrox 125mg/5ml

Suspension

Oral

Suspension

Cefuroxime Axetil Bp Equivalent

To Cefuroxime 125mg Per 5ml

Ccl Pharmaceuticals, 62 –

Industrial Estate, Kot Lakhpat,

Lahore, Pakistan

7-Apr-09

H2009/16194/556 Kelfnir 300mg

Capsules

Capsules Cefdinir 300mg Glenmark 1-Sep-09

H2008/18446/810 Koact 156.25

Suspension

Oral

Suspension

Amoxicillin Trihydrate Ph. Eur.


125mg, Potassium Clavulanate Ph.

Eur. Equivalent To Clavulanic

Acid 31.25mg Per 5ml

Aurobindo 7-Apr-09

H2008/18448/811 Koact 312.50

Suspension

Oral

Suspension

Amoxicillin Trihydrate Ph. Eur.


250mg, Potassium Clavulanate Ph.

Eur. Equivalent To Clavulanic

Acid 62.5mg Per 5ml

Aurobindo 7-Apr-09

H2008/18688/858 Labcor 250mg

Capsules

Capsules Cefaclor Bp Equivalent To

Anydrous Cefaclor 250 Mg

Laboratory & Allied Ltd 7-Apr-09

H2009/19266/031 Lastinem 500 Mg

Injection

Injection Imipenem Usp Equivalent To

Anhydrous Imipenem 500 Mg,

Cilastatin Sodium Usp Equivalent

Cilastatin 500 Mg Per Vial

Venus Remedies Ltd, Unit Ii:

Hill Top Industrial Estate,

Jharmajri, Epip, Phase I

(Extension), Bhatoli, Kalan,

Baddi-H.P. India

7-Apr-09

H2009/20275/674 Lefelo 500mg Tablets Tablets Levofloxacin Trihydrate 500mg Gracure Pharmaceuticals Ltd

For Regency Pharmaceuticals

Ltd

6-Oct-09



Registration

H2008/18481/558 Levobac 500mg

Tablets

Tablets Levofloxacin Hemihydrate Inn

Equivalent To Levofloxacin

500mg


Bangladesh

7-Apr-09

H2009/20516/735 Levobact 250mg

Tablets

Tablets Levofloxacin Hemihydrate


250mg

Micro Labs Ltd; India 2-Dec-09

H2009/19992/174 Levocin Infusion Injection Levofloxacin Hemihydrate


500mg

Pt Sanbe Farma 7-Apr-09

H2008/19011/813 Levonix 500 Tablets Tablets Levofloxacin Inn 500mg Opsonin Pharma Limited 7-Apr-09

H2008/19724/917 Levoquin 500 Mg

Tablets

Tablets Levofloxacin Hemihydrate Inn


Mg

Navana Pharmaceuticals 7-Apr-09

H2008/18829/918 Levox 500 Tablets Tablets Levofloxacin Hemihydrate


500mg

Cipla Ltd. Central Mumbai 7-Apr-09

H2008/19702/919 Lexx 500 Tablets Tablets Levofloxacin Hemihydrate


Mg


Manufactured By Unicure

Remedies Pvt Ltd

7-Apr-09

H2009/20126/067 L-Flox 500 Tablets Tablets Levofloxacin Hemihydrate

Equivalent To Levofloxacin 500

Mg

Lupin Ltd 7-Apr-09

H2009/19400/175 Linospan-600 Tablets Tablets Linezolid 600mg Cipla 7-Apr-09

H2008/18828/446 Maxime For Injection Injection Cefepime 1gm Per Vial Cipla Ltd;India 7-Apr-09

H2008/19858/1045 Mazit 250mg Capsules Capsules Azithromycin Dihydrate 250mg

As Dihydrate

Neopharma, Abu Dhabi,Uae 7-Apr-09

H2008/19831/904 Medifix-200 Tablets Tablets Cefixime Usp 200mg Meditab, India 7-Apr-09

H2009/19208/146 Medim 0.5gm Injection Injection Cefepime Hcl Usp And L-

Arginine Equivalent To Cefepime

0.5gm Per Vial

Mediorals Laboratories Pvt Ltd,

L-2, Additional M. I. D. C,

Satara, 415 004, India

7-Apr-09

H2009/20463/675 Medomox 250mg

Capsules

Capsules Amoxicillin 250 Mg Medopharm Pvt Ltd 6-Oct-09

H2008/19762/920 Meropen 1g Iv

Injection

Injection Meropenem 1gm Usp Per Vial Renata Ltd 7-Apr-09

H2008/19758/921 Meropen 500mg Iv

Injection

Injection Meropenem 500mg Usp Per Vial Renata Ltd 7-Apr-09

H2008/15211/394 Mesporin 250 Injection Injection Ceftriaxone Disodium 298.25 Mg

Equivalent To Ceftriaxone250 Mg

Labesfal S.A; Portugal For

Mepha; Switzerland

7-Apr-09

H2008/19436/762 Mextil Suspension Oral

Suspension


To Cefuroxime 125mg Per 5ml

Biopharma Laboratories Ltd,

Tongi, Bangladesh

7-Apr-09

H2008/19498/962 Moxacil Forte

Suspension

Oral

Suspension

Amoxycillin 3h2o Equivalent To

Amoxycillin 250 Mg Per 5ml


Bangladesh

7-Apr-09

H2009/19524/387 Moxicip 400 Mg

Tablets

Tablets Moxifloxacin 400 Mg Cipla Ltd; India 6-Aug-09

H2008/19721/887 Moxicip 400mg/100ml

Infusion

Injection Moxifloxacin Hydrochloride

Equivalent To Moxifloxacin

400mg, Mannitol Ip 5%W/V


H2009/19562/203 Moxiget 400mg Tablets Tablets Moxifloxacin 400mg Getz Phama Ltd, 29-30/27,

Karachi, Pakistan

7-Apr-09

H2009/19109/176 Moximac 400 Mg

Tablets

Tablets Moxifloxacin 400 Mg Macleods Pharmaceuticals Ltd 7-Apr-09

H2009/20140/562 Neocip-500 Tablets Tablets Ciprofloxacin Hydrochloride Bp

Equivalent To Ciprofloxacin

500mg

Okasa Pharma Pvt. Ltd 1-Sep-09

H2008/19859/1046 Neocipro 500 Mg

Tablets

Tablets Ciprofloxacin Usp 500 Mg Neopharma, Abu Dhabi,Uae 7-Apr-09

H2009/20812/739 Neoclav 1gm Tablets Tablets Amoxicillin As Amoxicillin

Trihydrate 875mg And Clavulanic

Acid As The Potassium Salt

125mg

Neopharma 2-Dec-09

H2009/19855/035 Neoclav 228.5mg/5ml

Suspension

Oral

Suspension


Equivalent To Amoxicillin 200mg

Per 5ml


H2008/19854/1047 Neoclav 375mg Tablets Tablets Amoxicillin 250mg As The

Trihydrate, Clavulanic Acid

125mg As The Potassium Salt


H2009/19857/036 Neoclav 457mg/5ml

Suspension

Oral

Suspension



400mg, Clavulanic Acid 57mg As

The Potassium Salt Bp Per 5ml


H2008/19853/1048 Neoclav 625mg Tablets Tablets Amoxicillin 500mg As The

Trihydrate, Clavulanic Acid

125mg As The Potassium Salt



212


Registration

H2009/20174/058 Neomox 125mg/5ml

Suspension

Oral

Suspension

Amoxycillin Trihydrate Bp

Equivalent To Amoxycillin

125mg Per 5ml

Neopharma; Uae 7-Apr-09

H2008/19856/1049 Neomox 250mg/5ml

Suspension

Oral

Suspension

Amoxicillin 250mg As Trihydrate

Bp Per 5ml


H2009/16337/256 Nesmox 100ml

Suspension

Oral

Suspension


Equivalent To Amoxicillin 125mg

Per 5ml

Nestor Pharmaceuticals Ltd 28-May-09

H2008/15789/794 Niclar 250 Tablets Tablets Clarithromycin Usp 250 Mg Gracure Pharmaceuticals Ltd 7-Apr-09

H2009/18183/706 Niclar-500 Tablets Tablets Clarithromycin Usp 500mg Gracure Pharmaceuticals Ltd 2-Dec-09

H2009/16513/204 Normoxil 500mg

Capsules

Capsules Amoxicillin 500mg Norbrook Kenya Ltd; Kenya 7-Apr-09

H2009/16217/132 Norzole Tablets Tablets Norfoxacin 400mg, Tinidazole

600mg


H2009/18466/565 Novaclav 625 Tablets Tablets Amoxicillin Trihydrate Bp


500mg, Clavulanic Acid 125mg

(As Clavulanate Potassium

Cipla 1-Sep-09

H2008/19839/889 Nutaxin Injection Injection Cefotaxime Sodium Usp 1gm Per

Vial



7-Apr-09

H2009/17553/465 Ocemax-200 Tablets Tablets Cefixime Trihydrate Equivalent

To Anhydrous Cefixime Usp

200mg

Cipla Ltd 6-Aug-09

H2008/16095/1022 Ococef 125 Oral

Suspension

Oral

Suspension

Cefadroxil Monohydrate Bp


Cefadroxil 125mg Per 5ml

Ochoa Laboratories 7-Apr-09

H2008/16097/1023 Ococef 250 Oral

Suspension

Oral

Suspension

Cefadroxil Monohydrate Bp


Cefadroxil 250mg Per 5ml

Ochoa Laboratories 7-Apr-09

H2008/19838/716 Ofloxacin 200mg

Tablets

Tablets Ofloxacin Usp 200mg Universal Corporation Ltd,

Kikuyu, Kenya

7-Apr-09

H2009/20189/179 Ogmentinine 1000

Tablets

Tablets Amoxicillin As Trihydrate 875mg,


Aleppo Pharmaceuticals 7-Apr-09

H2009/20191/180 Ogmentinine 375

Tablets




H2009/20190/181 Ogmentinine 625

Tablets




H2009/20346/474 Onecef 1000mg

Injection

Injection Ceftriaxone For Injection Usp

1000mg Per Vial

Kilitch Drugs Ltd 23-Jun-09

H2009/20343/475 Onecef 500mg

Injection

Injection Ceftriaxone For Injection Usp

500mg Per Vial


H2009/20345/476 Onecef-Sb Injection Injection Ceftriaxone For Injection Usp

1000mg, Sulbactam Sodium Usp

500mg Per Vial


H2009/19995/678 Oracef 500 Capsules Capsules Cephalexin Bp 500mg Dawa Ltd 6-Oct-09

H2009/19474/245 Otrim Ds Tablets Tablets Sulfamethoxazole Bp 800 Mg,

Trimethoprim Bp 160 Mg

Biopharma Laboratories Ltd

Tongi; Bangladesh

28-May-09

H2008/18771/1051 Oxirom - 150 Mg

Tablets

Tablets Roxithromycin Bp 150 Mg Pharmevo (Pvt) Ltd 7-Apr-09

H2008/19092/448 Pancef 1 Gm Injection Injection Ceftriaxone Sodium Usp

Equivalent To Ceftriaxone 1000

Mg Per Vial

Aglowmed Ltd; India 7-Apr-09

H2008/18060/764 Pancef-O 200 Tablets Tablets Cefixime U.S.P Equivalent To

Anhydrous Cefixime 200 Mg


Roorkee; India

7-Apr-09

H2009/20664/469 Pcillin 500 Capsules Capsules Ampicillin Bp 500mg (As

Trihydrate)

Zest Pharma For Synermed 6-Aug-09

H2008/18611/987 P-Clox 500mg

Injection

Injection Ampicillin Sodium Bp Equivalent

To Ampicillin 250mg, Cloxacillin

Sodium Bp Equivalent To

Cloxacillin 250mg Per Vial


H2009/20662/732 Pclox Dry Syrup Syrup Ampicillin Trihydrate Bp

Equivalent To Ampicillin 125mg,

Cloxacillin Sodium Bp Equivalent

To Cloxacillin 125mg

Zest Pharma 2-Dec-09

H2009/19656/569 Pimcef 1 G Injection Injection Cefepime 1.0 Gm (As Sterile

Mixture Of Cefepime Hcl And L-

Arginine)

Venus Remedies Limited 1-Sep-09

H2009/19652/525 Prazone-S 1g For

Injection

Injection Anhydrous Cefoperazone 500 Mg

Per Ml

Venus Remedies Limited 18-Aug-09

H2009/19652/570 Prazone-S 1gm

Injection

Injection Sulbactam Sodium Usp


Sulbactam 500mg, Cefoperazone

Sodium Usp Equivalent To

Anhydrous Cefoperazone 500mg

Venus Remedies 1-Sep-09



Registration

H2009/19653/571 Prazone-S 2gm

Injection

Injection Sulbactam Sodium Usp


Sulbactam 1000mg, Cefoperazone


Anhydrous Cefoperazone 1000mg

Per Vial

Venus Remedies 1-Sep-09

H2009/19653/526 Prazone-S2 For

Injection

Injection Anhydrous Cefoperazone 1000mg

Per Ml

Venus Remedies Limited 18-Aug-09

H2008/18633/397 Proximexa 125mg

Suspension

Oral

Suspension

Cefuroxime Axetil Equivalent To

Cefuroxime 125 Mg Per 5 Ml

Glaxosmithkline, Uk 7-Apr-09

H2008/18634/398 Proximexa 250mg

Suspension

Oral

Suspension

Cefuroxime Axetil Equivalent To

Cefuroxime 250 Mg Per 5 Ml


H2008/18632/399 Proximexa 250mg

Tablets

Tablets Cefuroxime Axetil Equivalent To

Cefuroxime 250 Mg


H2008/18631/400 Proximexa 500mg

Tablets

Tablets Cefuroxime Axetil Equivalent To

Cefuroxime 500 Mg


H2008/19114/477 Rancotrim Forte

Tablets

Tablets Sulphamethoxazole Bp 800mg;

Trimethoprim Bp 160mg

Ranbaxy Laboratories; India 7-Apr-09

H2008/19004/452 Resprox Oral

Suspension

Oral

Suspension

Roxithromycin Bp 50 Mg Per 5

Ml

Lark Laboratories (India) Ltd;

Sp-1192 E, Phase Iv,Bhiwadi

Industrial Area, Bhiwadi –

301019 Rajastan, India

7-Apr-09

H2009/20203/185 Rivaclarithrin 500mg

Capsules

Capsules Clarithromycin 500mg Riva Pharma Sae; Egypt 7-Apr-09

H2008/18912/871 Rivaclox 500 Capsules Capsules Ampicillin Trihydrate Equivalent

To Amplicillin 250mg, Cloxacillin

Sodium Equivalent To Cloxacillin

250mg

Riva Pharma S.A.E 7-Apr-09

H2009/20213/134 Rivaflux 500 Capsules Capsules Flucloxacillin Sodium Equivalent

To Flucloxacillin 500mg

Riva Pharma; Egypt 7-Apr-09

H2008/19357/564 Rivalexin 125

Suspension

Oral

Suspension

Cefalexin Monohydrate

Equivalent To 125mg Per 5ml

Riva Pharma Sae, Free Zone


7-Apr-09

H2008/19356/565 Rivalexin 500 Capsules Capsules Cefalexin Monohydrate

Equivalent To 500mg Cefalexin

Riva Pharma Sae, Free Zone


7-Apr-09

H2008/18780/412 Rivamox 125 Oral

Suspension

Oral

Suspension


To Amoxicillin 125 Mg Per 5ml

Riva Pharma S.A.E.Free Zone

Nasr City, Cairo, Egypt

7-Apr-09

H2008/19808/905 Rivamox 250mg Oral

Suspension

Oral

Suspension


To Amoxicillin 250 Mg Per 5ml

Riva Pharma S.A.E 7-Apr-09

H2008/18779/413 Rivamox 500 Capsules Capsules Amoxicillin Trihydrate Equivalent

To Amoxicillin 500mg

Riva Pharma 7-Apr-09

H2008/19184/589 Rivaxime Powder For

Suspension

Oral

Suspension

Cefixime Trihydrate Equivalent

To Cefixime 100mg Per 5ml

Riva Pharma S.A.E , Free Zone

Nasr, Cairo, Egypt

7-Apr-09

H2008/19298/795 Rogodox Capsules Capsules Doxycycline Bp 100mg Jiangxi Xier Kangtai

Pharmaceuticals Ltd

7-Apr-09

H2009/19651/217 Ronem 500mg

Injection

Injection Meropenem Trihydrate Equivalent

To Anhydrous Meropenem Usp

500mg Per Vial

Venus Remedies Limited; India 28-May-09

H2009/15981/629 Roxicef 250mg

Injection

Injection Cefuroxime (As Cefuroxime

Sodium B.P) 250mg Per Vial

Medreich Sterilab Ltd 15-Sep-09

H2008/18866/454 Roxy 300 Mg Tablets Tablets Roxythromycin Usp 300 Mg Universal Corporation Ltd; P.O.

Box 1748 – 00902 Kikuyu,

Kenya

7-Apr-09

H2008/19388/414 Rozifine 1g Injection Injection Ceftriaxone 1gm Per Vial National Company For


Aleppo, Syria

7-Apr-09

H2008/19389/415 Rozifine 2g Injection Injection Ceftriaxone 2gm Per Vial National Company For


Aleppo, Syria

7-Apr-09

H2008/19387/416 Rozifine 500mg

Injection

Injection Ceftriaxone 500mg Per Vial National Company For


Aleppo, Syria

7-Apr-09

H2009/19133/423 Rtist Powder For Oral

Suspension

Oral

Suspension

Cefdinir 125 Mg Per Ml Lupin Ltd; India 6-Aug-09

H2008/19117/402 Rulicin Tablets 150mg Tablets Roxithromycin Bp 150 Mg Agio Pharmaceuticals Ltd 7-Apr-09

H2008/19009/680 Sefur 750 Injection Injection Cefuroxime 750mg Per Vial Opsonin 7-Apr-09

H2008/19010/923 Sefur Powder For

Suspension

Oral

Suspension


To Cefuroxime 125 Mg Per 5ml

Opsonin Pharma 7-Apr-09

H2008/19503/681 Specbac 1gm Injection Injection Meropenem Usp 1gm Square Pharmaceuticals Ltd.,


Bangladesh

7-Apr-09

H2008/19918/908 Specbac 500mg

Injection

Injection Meropenem Usp 500mg Per Vial Square Pharmaceuticals 7-Apr-09

H2009/19459/258 Spectrix 500 Mg

Tablets

Tablets Levofloxacin 500 Mg Pharm Evo (Pvt) Ltd 28-May-09


214


Registration

H2008/18519/725 Streptomycin Injection

1g

Injection Streptomycin Sulphate B.P

Equivalent To Streptomycin 1g

Shijiazhuang Pharma Group 7-Apr-09

H2008/19268/893 Sulbactomax 1500 Mg

Injection



Ceftriaxone 1000 Mg, Sulbactam


Anhydrous Sulbactam 500 Mg Per

Vial

Venus Remedies Ltd, India 7-Apr-09

H2008/19267/895 Sulbactomax 750 Mg

Injection



Ceftriaxone 500 Mg, Sulbactam


Anhydrous Sulbactam 250 Mg Per

Vial

Venus Remedies Ltd, India 7-Apr-09

H2008/19515/950 Sulfrab Kid Dispersible

Tablets

Tablets Sulphamethoxazole Bp 100mg

Trimethoprim Bp 20 Mg

Universal Corporation Ltd,

Kenya

7-Apr-09

H2008/19568/627 Sulfran-Ds Caplets Tablets Sulphamethoxazole Bp 800mg,



Kenya

7-Apr-09

H2008/18766/994 Syner-Cef 250mg

Tablets

Tablets Cefuroxime Axetil Usp Equivalent

To Cefuroxime 250mg


H2009/18762/430 Syner-Cef 500 Tablets Tablets Cefuroxime Axetil Usp 500mg Swiss Parenterals Ltd; India 6-Aug-09

H2009/19845/413 Tazocin 4 Ef Injection Injection Piperacillin 4gm (As The Sodium

Salt); Tazobactam 500mg (As The

Sodium Salt) Per Vial

Wyeth South Africa (Pty) Ltd,

South Africa

6-Aug-09

H2009/20730/733 Throcin Suspension Suspension Erythromycin Stearate Bp

Equivalent Erythromicin 200mg

Zest Pharma 2-Dec-09

H2009/19636/579 Tprim 960 Tablets Tablets Sulphamethoxazole Bp 800mg,


Alkem Laboratories Ltd; 1-Sep-09

H2009/19730/107 Traxol-S 1.5g Injection Injection Ceftriaxone Sodium Usp

Equivalent To Ceftriaxone

1000mg, Sulbactum Sodium Usp

Equivalent To Sulbactum 500mg

Per Vial

Alkem Laboratories Ltd 7-Apr-09

H2008/19014/684 Traxon 1g Injection Injection Ceftriaxone 1g Per Vial Opsonin 7-Apr-09

H2009/19917/042 Trevox Oral Solution Oral Solution Levofloxacin 250 Mg As

Levofloxacin Hemihydrate Inn Per

5 Ml

Square Pharmaceuticals Ltd 7-Apr-09

H2009/19070/385 Triaxone Injection Injection Ceftriaxone Sodium Ph. Eur.

Equivalent To Ceftriaxone

1000mg Per Vial


H2009/19638/252 Trimoprim Tablets Tablets Sulphamethoxazole Bp 800mg,


Medreich Ltd 28-May-09

H2009/19006/659 U-Cef Injection Injection Cefuroxime Sodium Equivalent

To Cefuroxime 750 Mg Per Vial

Vitapure Corporation; India 29-Sep-09

H2009/19007/660 U-Cef Tablets Tablets Cefuroxime 500 Mg Vitapure Corporation; India 29-Sep-09

H2008/11277/800 Ugiflox-400 Tablets Tablets Norfloxacin Usp 400mg Gracure Pharmaceuticals Ltd 7-Apr-09

H2008/18977/522 Unictam 375mg

Tablets

Tablets Sultamicillin Tosylate Equivalent

To Sultamicillin 375mg

Medical Union; Egypt 7-Apr-09

H2009/18434/389 Vagiclin Vaginal

Suppositories

Vaginal

Suppositories

Clindamycin Phosphate Bp

Equivalent To Clindamycin 100

Mg; Clotrimazole Bp 100 Mg

Erica Pharma Ltd 6-Aug-09

H2009/19071/429 Vanco 500 Injection Injection Vancomycin Hcl Usp 500mg Per

Vial

Swiss Parenterals Ltd; India 6-Aug-09

H2009/19818/341 Vaxcel Injection Injection Ceftazidimepentahydrate 1gm Per

Vial

Kotra Pharma-Malaysia 6-Aug-09

H2009/18450/386 Z Mox 250 Suspension

250mg/5ml

Oral

Suspension

Amoxicillin Usp Equivalent To

Anhydrous Amoxicillin 250mg

Per 5ml


H2009/19672/043 Zaha 250mg Tablets Tablets Azithromycin Dihydrate Usp

Equivalent To Azithromycin Usp

250mg

Ajanta Pharma Ltd; Factory: B-

4/5/6, M.I.Dc. Area, Paitahn 431

128, India

7-Apr-09

H2009/19673/044 Zaha 500mg Tablets Tablets Azithromycin Dihydrate Usp

Equivalent To Azithromycin Usp

500mg



128, India

7-Apr-09

H2008/16548/1056 Zathrin 500mg Tablets Tablets Azithromycin Usp 500mg Fdc (Private) Ltd; India 7-Apr-09

H2009/19637/074 Zaxter 1gm Injection Injection Meropenem 3h2o Usp Equivalent

To Anhydrous Meropenem 1gm

Alkem Laboratories Ltd 7-Apr-09

H2009/20344/479 Zetax-Sb Injection Injection Cefotaxime For Injection Usp

1000mg, Sulbactam Sodium Usp

500mg Per Vial


H2008/19512/595 Zetro 250 Mg Capsules Capsules Azithromycin 250mg Getz Pharma (Pvt) Ltd; 29-

30/27, K.I.A. Karachi; Pakistan

7-Apr-09

H2009/19567/045 Zetro Powder For Oral

Suspension

Oral

Suspension

Azithromycin Usp 200mg Per 5ml Getz Phama Ltd, 29-30/27,

Karachi, Pakistan

7-Apr-09



Registration

H2008/18583/382 Zimax 500 Tablets Tablets Azithromycin Dihydrate Usp 500

Mg

Square Pharmaceuticals 7-Apr-09

H2009/20357/307 Zimax Suspension Oral

Suspension

Azithromycin Usp 200mg Per 5

Ml


Bangladesh

7-Apr-09

H2009/18902/047 Zithroriv 200mg/5ml

Suspension

Oral

Suspension

Azithromycin Dihydrate


200mg Per 5ml

Riva Pharma; Egypt 7-Apr-09

H2008/18903/942 Zithroriv 500mg

Capsules

Capsules Azithromycin Dihydrate


500mg

Riva Pharma S.A.E. Free Zone

Nasr City, Cairo, Egypt

7-Apr-09

H2009/19930/046 Zithrox 200mg/5ml

Suspension

Oral

Suspension



200mg Per 5ml

Eskayef, Bangladesh 7-Apr-09

H2009/20356/445 Zithrox 500 Tablets Tablets Azithromycin 500 Mg Eskayef; Bangladesh 6-Aug-09

H2008/16205/801 Zocin Oral Suspension Oral

Suspension

Azithromycin Usp 200mg Per 5ml Advanced Pharmaceutical

Industries Ltd –Sahab Jordan

7-Apr-09

H2009/20507/588 Zomax 250 Tablets Tablets Azithromycin Usp 250mg Hikma Pharmaceuticals 1-Sep-09

H2009/20506/589 Zomax 500 Tablets Tablets Azithromycin Usp 500mg Hikma Pharmaceuticals 1-Sep-09

H2008/13226/823 Zynclar – 250 Tablets Tablets Clarithromycin Usp 250mg Cipla 7-Apr-09

Anti-Fungals

H2008/18385/841 Alkanazole 150 Mg

Capsules

Capsules Fluconazole 150 Mg Alkan Pharma S.A.E 7-Apr-09

H2009/20099/230 Ascenva Pessaries Pessaries Clotrimazole Bp 100mg Ambalal Sarabhai , India 28-May-09

H2009/19742/646 Candizole Tablets Tablets Fluconazole 50.0mg Pmc Ltd-Kenya 29-Sep-09

H2009/20351/495 Clozole-V3 Pessaries Pessaries Clotrimazole Bp 200mg Pmc Ltd-Kenya 4-Aug-09

H2009/18548/119 Ecozole Pessaries Pessaries Econazole Nitrate Bp Equivalent

To Econazole 150mg

Bliss Gvs Pharma Ltd; India 7-Apr-09

H2008/19282/1010 Etocon Tablets 200mg Tablets Ketoconazole Usp 200mg Sterling Lab 7-Apr-09

H2008/19950/1042 Flucariv Capsules Capsules Fluconazole 150mg Riva Pharma, Cairo, Egypt 7-Apr-09

H2009/20609/362 Flucimet-150 Tablets Tablets Fluconazole 150mg Unicure For Metro 6-Aug-09



H2008/19461/515 Fulcover 100 Mg

Capsules

Capsules Itraconazole 100 Mg Saga Laboratories; Plot 1409,



India

7-Apr-09

H2008/19418/852 Fungata 150 Mg

Capsules

Capsules Fluconazole Inn 150 Mg Biopharma Laboratory Ltd 7-Apr-09

H2008/18823/555 Fungistop 150 Mg

Capsules

Capsules Fluconazole Usp 150 Mg Fourrts Laboratories Ltd; India 7-Apr-09

H2009/18643/98 Fungizol 2 Mg/ Ml

Infusion

Injection Fluconazole 2 Mg Per 1 Ml Oubari Pharma 7-Apr-09

H2009/18360/065 Griseofulvin Tablets

Bp 250mg

Tablets Griseofulvin Bp 250mg Gracure Labs 7-Apr-09

H2009/20310/287 Griso 250mg Tablets Tablets Griseofulvin Bp 250mg Cosmos Ltd; Kenya 28-May-09

H2009/17720/028 Gvfluc Powder For

Oral Suspension

Oral

Suspension

Fluconazole 50mg Per 5ml Bliss Gvs Pharma Ltd; India 7-Apr-09

H2009/20611/365 Itramet Capsules Capsules Itraconazole 100mg Unicure For Metro 6-Aug-09

H2008/1877/730 Kecozol 200mg Tablets Tablets Ketoconazole Usp 200mg Biodeal Laboaratories Ltd,

Kenya

7-Apr-09

H2009/21048/663 Kenazole 200mg

Tablets

Tablets Ketoconazole 200mg Pharma International Co; Jordan 1-Oct-09

H2009/20361/306 Kensren Vt 6 Pessaries Pessaries Clotrimazole Bp 100mg Square Pharmaceuticals Ltd;

Bangladesh

28-May-09

H2008/19391/791 Ketoconazole Tablets Tablets Ketoconazole Usp 200mg Sishui Xierkang Pharm Ltd;

China

7-Apr-09

H2008/17638/518 Kinazol Shampoo Topical

Solution

Ketoconazole 200mg Dafra Pharma Nv/Sa; Belgium 7-Apr-09

H2008/15515/756 Konazol Tablets 200mg Tablets Ketoconazole Usp 200mg Lincoln Pharmaceuticals 7-Apr-09

H2009/16005/200 Lucon Oral Suspension Oral

Suspension

Fluconazole 50mg Per 5 Ml Medreich Sterilab Ltd 7-Apr-09

H2008/16399/447 Miko-Penotran

Pessaries

Pessaries Miconazole Nitrate 1200 Mg Embil Pharmaceutical Co. Ltd 7-Apr-09

H2008/19744/653 Noxafil Oral

Suspension

Oral

Suspension

Posaconazole 40mg Per Ml Schering Plough Ltd 7-Apr-09

H2009/19836/069 Odaft-150 Capsules Capsules Fluconazole Usp 150mg Plethico Pharmaceuticals Ltd,



7-Apr-09

H2008/18540/481 Terbinafine 250 Mg

Tablets

Tablets Terbinafine Hydrochloride

Equivalent To Terbinafine 250

Mg


H2008/18687/821 Ucozole Capsules Capsules Fluconazole 200 Mg Lab And Allied 7-Apr-09

H2008/18938/968 Umifulvin-125 Tablets Tablets

Griseofulvin Bp 125mg Umedica; India 7-Apr-09


216


Registration

H2008/18740/456 Unisten V-1 Vaginal

Tablets

Vaginal

Tablets

Clotrimazole Bp 500 Mg Regal Pharmaceuticals Ltd; Plot

# 7879/18, Off Baba Dogo Road

Ruaraka, P.B. 44421 – Gpo

Nairobi; Kenya

7-Apr-09

H2008/18741/457 Unisten V-6 Vaginal

Tablet

Vaginal

Tablets

Clotrimazole Bp 100 Mg Regal Pharmaceuticals Ltd; Plot

# 7879/18, Off Baba Dogo Road

Ruaraka, P.B. 44421 – Gpo

Nairobi; Kenya

7-Apr-09

Anti-Virals

H2009/19912/213 Aciclovir 400mg

Tablets

Tablets Aciclovir Bp 400mg Flamingo Pharmaceuticals,

India

28-May-09

H2009/19420/141 Aciherpin 400 Tablets Tablets Aciclovir Bp 400mg Agio Pharmaceuticals Ltd; India 7-Apr-09

H2008/11880/777 Acivir-400 Dt Tablets Tablets Acyclovir B.P 400mg Cipla Ltd; India 7-Apr-09

H2009/20183/264 Azzir 400mg Tablets Tablets Aciclovir Bp 400mg Unicure Remedies; India For


28-May-09

H2008/16283/947 Hepirax Dispersible

Tablets

Tablets Acyclovir 200mg Ccms Pharma 7-Apr-09

H2008/19452/770 Univir 800mg Caplets Tablets Acyclovir Bp 800mg Universal Corporation, Kikuyu,

Kenya

7-Apr-09

H2008/16837/438 Univir Suspension Oral

Suspension

Acyclovir Usp 200 Mg Per 5 Ml Universal Corporation 7-Apr-09

H2009/20452/239 Virest 4000mg Tablets Tablets Aciclovir 400mg Hovid Bhd 28-May-09

Anti-Retrovirals

H2009/17384/734 Abacavir 300mg

Tablets

Tablets Abacavir 300mg (As Sulphate) Cipla Ltd 2-Dec-09

H2009/19935/059 Abacavir 60mg/

Lamivudine 30mg

/Zidovudine 60mg

Tablets

Tablets Abacavir Sulfate 60mg,

Lamivudine Usp 30mg,

Zidovudine Usp 60mg

Matrix Labs 7-Apr-09

H2008/18998/504 Abacavir Sulfate Oral

Solution

Oral Solution Abacavir Sulfate Equivalent To

Abacavir 20mg Per Ml




7-Apr-09

H2008/17685/460 Abacavir Sulfate

Tablets

Tablets Abacavir 300mg Aurobindo Pharma Ltd; Plot



7-Apr-09

H2009/20048/617 Abacavir Sulphate

60mg/Lamivudine

30mg Tablets

Tablets Abacavir 60 Mg, Lamivudine

U.S.P 30 Mg

Matrix Laboratories Ltd 15-Sep-09

H2009/20047/618 Abacavir Sulphate

Tablets 60mg

Tablets Abacavir 60 Mg Matrix Laboratories Ltd; India 15-Sep-09

H2008/18314/654 Atripla Tablets Tablets Efivarenz 600mg, Emtricitabine

200mg, Tenofovir Disproxil

Fumarate 300mg

Merck Sharp & Dohme 7-Apr-09

H2008/17833/829 Avirodin-400 Capsules Capsules Indinavir Sulphate Usp Equivalent

To Indinavir 400mg


H2008/19168/552 Avocomb-E Tablets Tablets Lamivudine Usp 150mg;

Zidovudine Usp 300mg; Efavirenz

600mg


H2008/19483/848 Celsentri 150mg

Tablets

Tablets Maraviroc 150mg Pfizer Limited 7-Apr-09

H2008/19484/849 Celsentri 300 Mg

Tablets

Tablets Maraviroc 300mg Pfizer Limited 7-Apr-09

H2009/17385/545 Divir-200mg Tablets Tablets Didanosine 200mg Cipla Ltd 1-Sep-09

H2009/17386/546 Divir-25mg Tablets Tablets Didanosine 25mg Cipla Ltd 1-Sep-09

H2009/15470/023 Efariv Capsules 200mg Capsules Efavirenz 200mg Cosmos Ltd; Kenya 7-Apr-09

H2009/20699/449 Efavirenz Tablets

600mg

Tablets Efavirenz 600mg Macleods; India 6-Aug-09

H2009/17690/024 Efcure 200 Mg Tablets Tablets Efavirenz 200 Mg Emcure Pharmaceuticals Ltd;

India

7-Apr-09

H2008/17734/700 Flufly 75mg Capsules Capsules Oseltamivir 75mg Julphar, Gulf 7-Apr-09

H2009/19514/029 Isentress 400mg

Tablets

Tablets Raltegravir 400mg Merck Sharp & Dohme Bv,

Waarderweg 39, 2031 Bn

Haarlem, Netherlands

7-Apr-09

H2008/15329/066 Lamivir Oral Solution

(100ml)

Solution Lamivudine 50 Mgper 5ml Cipla Ltd; India 13-Feb-08

H2009/20700/603 Lamivudine 150 &

Zidovudine 300mg

Tablets

Tablets Lamivudine Usp 150mg;

Zidovudine Usp 300mg


India

8-Sep-09

H2008/18121/475 Lamivudine

150/Zidovudine

300/Nevirapine 200

Tablets

Tablets Lamivudine 150mg; Zidovudine

300mg; Nevirapine 200mg




7-Apr-09

H2009/20702/604 Lamivudine Tablets

150 Mg

Tablets Lamivudine U.S.P 150 Mg Macleods Pharmaceuticals Ltd;

India

8-Sep-09



Registration

H2008/19936/1043 Lamivudine/

Nevirapine/ Zidovudine

30mg/50mg/60mg

Tablets

Tablets Lamivudineusp 30mg, Nevirapine

Usp 50mg, Zidovudine Usp 60mg

Matrix Laboratories 7-Apr-09

H2008/19593/986 Lamivudine/Zidovudin

e Tablets

Tablets Lamivudine Usp 150 Mg,

Zidovudine Usp 300 Mg

Matrix Labs 7-Apr-09

H2009/20226/368 Lamozid 150/300mg

Tablets

Tablets Lamivudine 150mg, Zidovudine

300mg

Universal Corporation 6-Aug-09

H2009/17692/326 Lavir Solution 100ml Oral Solution Lamivudine Usp 50mg Emcure Pharmaceuticals 6-Aug-09

H2008/18961/1018 Lopinavir/Ritonavir

200mg/50mg Tablets

Tablets Lopinavir 200 Mg, Ritonavir Usp

50 Mg

Matrix Laboratories Ltd 7-Apr-09

H2009/19590/715 Nevirapine Tablets

200mg

Tablets Nevirapine U.S.P 200mg Matrix Laboratories Ltd 2-Dec-09

H2009/20701/608 Nevirapine Tablets

U.S.P 200mg

Tablets Nevirapine U.S.P 200 Mg Macleods Pharmaceuticals Ltd;

India

8-Sep-09

H2008/18054/705 Oseflu Capsules Capsules Oseltamivir Phosphate Inn

Equivalent To Oseltamivir 75mg

Beximco Pharmaceuticals Ltd 7-Apr-09

H2008/19489/766 Prezista 300 Mg

Tablets

Tablets Darunavir Ethanolate 325.23 Mg

Equivalent To Darunavir 300 Mg

Janssen Ortho Llc, State Rd 933

Km 0,1 Mamey Ward, Gurabo,

Puerto Rico, 00778

7-Apr-09

H2008/19235/590 Stocrin 200mg Tablets Tablets Efavirenz 200mg Merck Sharp & Dohme B.V. 7-Apr-09

H2008/19236/591 Stocrin 50 Mg Tablets Tablets Efavirenz 50mg Merck Sharp & Dohme B.V. 7-Apr-09

H2009/18596/682 Zidovudine 100

Capsules

Capsules Zidovudine Usp 100mg Aurobindo Pharma Ltd 2-Dec-09

H2008/19592/1057 Zidovudine 300mg

Tablets

Tablets Zidovudine Usp 300mg Matrix Laboratories Limited. (A

Subsidiary Of Mylan

Laboratories Inc.) F-4 & F-12,

Midc, Malegaon, Sinnar,

Nashik – 422 113,Maharashtra,

India

7-Apr-09

H2009/20698/615 Zidovudine Tablets

Usp 300mg

Tablets Zidovudine Usp 300mg Macleods Pharmaceuticals Ltd;

India

8-Sep-09

Drugs Used For Treatment Of Tuberculosis

H2009/18282/048 Akurit Kid Tablets Tablets Rifampicin U.S.P. 60 Mg,

Isoniazid U.S.P. 30 Mg

Lupin Ltd 7-Apr-09

H2009/19949/464 Ebsar 2-Ds Tablets Tablets Rifampicin Bp 300mg, Isoniazid

Bp 150mg

Rusan Pharma, Kandivli, India 6-Aug-09

H2009/19948/463 Ebsar Tablets Tablets Rifampicin Bp 150mg, Isoniazid

Bp 75mg

Rusan Pharma, Kandivli, India 6-Aug-09

H2009/19134/448 Ethide Tablets Tablets Ethionamide Usp 250 Mg Lupin Ltd; India 6-Aug-09

H2008/18820/832 Ethomid Tablets Tablets Ethionamide 250 Mg Macleods Pharmaceuticals Ltd,

Plot # 25-27, Survey # 366,

Premier Industrial Estate,

Kachigam, Daman 396 210

(U.T.), Anderi (E), Mumbai –

400 059, India

7-Apr-09

H2009/20224/456 Isonide 100 Mg Tablets Tablets Isoniazid B.P 100mg Per Vial Universal Corporation Ltd;

Kenya

6-Aug-09

H2009/18922/401 Protomid Tablets Tablets Prothionamide 250mg Macleods; India 6-Aug-09

H2009/16546/573 Rifampicin 150mg

Capsules

Capsules Rifampicin B.P 150mg Elys Chemicals Ltd; Kenya 1-Sep-09

H2009/20455/627 Rifampicin 60

Mg/Isoniazid 30 Mg/

Pyrazinamide 150 Mg

Tablets

Tablets Rifampicin Bp 60mg, Isoniazid

Bp 30mg

Svizera Labs 15-Sep-09

H2008/19251/453 Rifampicin 60mg/

Isoniazid 30 Mg

Dispersible Tablets

Tablets Rifampicin Bp 60mg; Isoniazid

Bp 30 Mg


India

7-Apr-09

H2009/20453/628 Rifampicin 60mg/

Isoniazid 60mg Tablets

Tablets Rifampicin Bp 60mg, Isoniazid

Bp 60

Svizera 15-Sep-09

H2009/18832/681 Rihaz – P Tablets Tablets Rifampicin Bp 60mg, Isoniazid

Bp 30mg, Pyrazinamide Bp

150mg

Cosmos Ltd., Rangwe Road, 6-Oct-09

H2008/18208/379 Rihide E Tablets Tablets Ethambutol Hydrochloride Usp

275 Mg

Cosmos Limited; Kenya 7-Apr-09

H2008/19332/436 Rimactazid Paed 60/30

Tablets

Tablets Rifampicin 60 Mg; Isoniazid 30

Mg

Sandoz 7-Apr-09

Drugs Used For Migrane

H2008/19345/385 Migranil Forte Tablets Tablets Ergotamine Tartrate Bp 1mg;

Caffeine Bp 100 Mg

Inga Laboratories (Pvt) Ltd;

India

7-Apr-09

Antineoplastics & Immunosuppressive Drugs

H2009/20682/317 Actemra 200mg

Infusion

Injection Tocilizumab 200mg Chugai Pharma 6-Aug-09


218


Registration

H2009/20683/318 Actemra 400mg

Infusion

Injection Tocilizumab 400mg Chugai Pharma 6-Aug-09

H2009/20681/319 Actemra 80mg Infusion Injection Tocilizumab 80mg Chugai Pharma 6-Aug-09

H2008/19548/733 Adricin 10mg Injection Injection Doxorubicin Hcl 10mg Korea United Pharm. Inc. 153

Budong-Ri, Seo-Myeon,

Yeongi-Kun, Chungnam,, Korea

7-Apr-09

H2008/19547/734 Adricin 50mg Injection Injection Doxorubicin Hcl 50mg Korea United Pharm. Inc. 153



7-Apr-09

H2008/19413/510 Azoran 50mg Tablets Tablets Azathioprine Bp 50mg Rpg Life Sciences Ltd; India 7-Apr-09

H2008/18252/568 Biovorin 15 Mg/2 Ml

Injection

Injection Leucovorin Calcium Equivalent

To Leucovorin Usp 7.5 Mg Per Ml

Biochem Pharmaceutical Ltd;

India

7-Apr-09

H2009/19202/693 Bleomycin Injection Injection Bleomycin Sulfate Usp Equivalent

To Bleomycin 15 Units

Dabur Pharma Ltd 2-Dec-09

H2009/19533/407 Caelyx 2mg/Ml

Injection

Injection Doxorubicin 20 Mg Per Vial Schering Plough; Belgium 6-Aug-09

H2009/20111/488 Canol 2.5mg Injection Injection Topotecan Hydrochloride

Equivalent To Topotecan 2.5mg

Per Vial


H2008/18805/846 Carbol Injection Bp Injection Carboplatin Bp 10 Mg Per Ml

And Water For Injection Bp (As

Diluent)

Venus Remedies Limited 7-Apr-09

H2008/19748/650 Cellcept Capsules Capsules Mycophenolate Mofetil 250mg Roche 7-Apr-09

H2009/19890/411 Cristol 1mg/Ml

Injection

Injection Vincristine Sulphate Usp 1mg Per

Ml


H2009/19534/077 Remicade 100 Mg

Injection

Injection Infliximab 10 Mg Per Vial Schering Plough 7-Apr-09

H2008/19551/739 Cycram 1gm Injection Injection Cyclophosphamide 1gm (As

Anhydride)

Korea United Pharm. Inc. 153



7-Apr-09

H2008/19552/740 Cycram 500mg

Injection

Injection Cyclophosphamide 500mg (As

Anhydride)

Korea United Pharm. Inc. 153



7-Apr-09

H2008/20150/1030 Dacticin Injection Injection Dactinomycin 0.5mg Korea United Pharm Inc. 7-Apr-09

H2008/18876/742 Docetax-20 Injection Injection Docetaxel Trihydrate Equivalent

To Anhydrous Docetaxel 20mg

Cipla Ltd., S-103 To S-105 & S-

109, Verna Industrial Estate,

Verna, Goa, India

7-Apr-09

H2008/18875/743 Docetax-80 Injection Injection Docetaxel Trihydrate Equivalent

To Anhydrous Docetaxel 80mg

Cipla Ltd., S-103 To S-105 & S-

109, Verna Industrial Estate,

Verna, Goa, India

7-Apr-09

H2009/19770/170 Donataxel 80mg

Injection

Injection Docetaxel 80mg Per Vial Bioprofarma S.A. 7-Apr-09

H2009/19771/548 Donataxel 20mg

Injection

Injection Docetaxel 20mg Per Vial Bioprofarma S.A.; Group Of

Bago Group; Argentina

1-Sep-09

H2008/19372/407 Doxol 20mg/0.5ml Injection Docetaxel Trihydrate 20mg Per

Vial;Solvent: Each Vial Contains:

Alcohol Usp (95%) 13% W/V;

Water For Injection Q.S. To 1.5

Ml

Venus Remedies Ltd 7-Apr-09

H2008/19371/408 Doxol 80mg/2.0ml Injection Docetaxel Trihydrate 80mg Per

Vial; Solvent: Each Vial Contains:

Alcohol Usp (95%) 13% W/V;

Water For Injection Q.S. To 6 Ml

Venus Remedies Ltd 7-Apr-09

H2008/19871/729 Finide 5 Tablets Tablets Finasteride Usp 5mg Cadila Healthcare,India 7-Apr-09

H2008/19662/603 Finone Tablets Tablets Finasteride Usp 1mg Unicure Remedies Pvt Ltd,

F/25, Bidc Estate, Gorwa India

7-Apr-09

H2009/20443/241 Finosin Tablets Tablets Finasteride Usp 5mg, Tamsulosin

Hcl Bp Equivalent To Tamsulosin

400mcg

Unicure Remedies Ltd; India 28-May-09

H2008/17610/788 Fivoflu 500mg

Injection

Injection Fluorouracil Usp 50mg Per Ml Dabur Pharma Ltd-India 7-Apr-09

H2009/16638/421 Fytosid 100mg

Injection (5ml)

Injection Etoposide Usp 100mg Per 5ml Fresenius Kabi Oncology Ltd;

India

6-Aug-09

H2008/18497/584 Gemtaz 1g Injection Injection Gemcitabine Hydrochloride Usp

Equivalent To Gemcitabine 1gm

Per Vial

Sun Pharmaceuticals Industries

Ltd, Halol – Baroda, Highway,

Halol – 389 350, Gujarat, India

7-Apr-09

H2009/20372/210 Herceptin 440mg

Tablets

Tablets Trastuzumab 440mg F. Hoffmann- La Roche Ltd;

Switzerland

7-Apr-09

H2009/20334/289 Hycamtin 0.25mg

Capsules

Capsules Topotecan Hydrochloride

Equivalent To Topotecan 0.25mg

Glaxosmithkline Ltd 28-May-09

H2009/20335/290 Hycamtin 1mg

Capsules

Capsules Topotecan Hydrochloride

Equivalent To Topotecan 1mg


H2008/19411/859 Mofetyl 250 Tablets Tablets Mycophenolate Mofetil Bp 250mg Rpg Lifesciences Ltd 7-Apr-09

H2008/19412/860 Mofetyl 500 Tablets Tablets Mycophenolate Mofetil Bp 500mg Rpg Lifesciences Ltd 7-Apr-09



Registration

H2008/19044/964 Neoflur Injection Injection Fluorouracil Bp 50mg Per Ml Cipla Ltd; India 7-Apr-09

H2009/19377/206 Nexavar 200mg Tablets Tablets Sorafenib (As Tosylate) 200mg Bayer Healthcare 7-Apr-09

H2008/18804/862 Oxol Injection Injection Oxolipatin Bp 2 Mg Per Ml And

Water For Injection Bp (As

Diluent)

Venus Remedies Limited 7-Apr-09

H2008/18106/494 Paclitaxel 100mg

Injection

Injection Paclitaxel 100mg Per 17.0ml Servycal S.A. For Glenmark;

India

7-Apr-09

H2008/18105/495 Paclitaxel 30mg

Injection

Injection Paclitaxel 30mg Per 5ml Servycal S.A. For Glenmark;

India

7-Apr-09

H2009/20113/410 Platol Injection Injection Cisplatin U.S.P 0.5 Mg, Sodium

Chloride U.S.P 90 Mg, Water For

Injection U.S.P Q.S Per Ml


H2009/20020/184 Rapamune 1mg Tablets Tablets Sirolimus 1mg Wyeth South Africa 7-Apr-09

H2009/19891/468 Sedol 100mg/5ml

Injection

Injection Etoposide Usp 20mg Per Ml Venus Remedies Ltd; India 6-Aug-09

H2009/20414/225 Tamsolin Capsules Capsules Tamsulosin 0.4mg Getz Pharma; Pakistan 28-May-09

H2008/18640/424 Tasigna 200 Mg

Capsules

Capsules Nilotinib 200 Mg Norvatis Pharma 7-Apr-09

H2009/20653/722 Temodal 140mg

Capsules

Capsules Temozolomide 140mg Schering 2-Dec-09

H2009/20654/723 Temodal 180mg Capsules Temozolomide 180mg Schering 2-Dec-09

H2009/19893/412 Trexol 50mg/2ml

Injection

Injection Methotrexate Usp 25mg Per Ml Venus Remedies Ltd; India 6-Aug-09

H2008/19553/924 Unitrexate 2.5mg

Tablets

Tablets Methotrexate 2.5mg Korea United Pharm. 7-Apr-09

H2008/19546/771 Utoral 250mg Injection Injection Fluorouracil 250mg Korea United Pharm. Inc. 153



7-Apr-09

H2008/19550/772 Utoral 500mg Injection Injection Fluorouracil 500mg Korea United Pharm. Inc. 153



7-Apr-09

H2009/19589/234 Vingraf-5 Capsules Capsules Tacrolimus 5mg Emcure Pharmaceuticals Ltd 28-May-09

Antiparkinsonism Drugs

H2009/19598/168 Cabergoline Tablets Tablets Cabergoline 0.5mg Sun Pharmaceutical 7-Apr-09

H2008/19521/503 Pexola 0.125 Mg

Tablets

Tablets Pramipexole Dihydrochloride H2o

0.125 Mg Equivalent To

Pramipexole 0.088 Mg

Boehringer Ingelheim

Pharmaceuticals (Pty) Ltd;

(Edms) Bpk, Pine Avenue;

Ferndale Randburg, Germany

7-Apr-09

H2008/19569/547 Pexola 0.25mg Tablets Tablets Pramipexole Dihydrochloride

Monohydrate 0.25mg

Boehringer Ingelheim Pine

Avenue Iaan, Randburg;

Germany

7-Apr-09

H2008/19570/548 Pexola 1mg Tablets Tablets Pramipexole Dihydrochloride

Monohydrate 1mg

Boehringer Ingelheim Pine

Avenue Iaan, Randburg; Germ.

7-Apr-09

Drugs Affecting The Blood

H2009/19684/050 Arixtra 2.5mg/0.5ml

Injection

Injection Fondaparinux Sodium 2.5mg Per

0.5ml

Glaxosmithkline Ltd 7-Apr-09

H2009/19685/051 Arixtra 7.5mg/0.6ml

Injection

Injection Fondaparinux Sodium 7.5mg Per

0.6ml


H2008/19367/638 Asiapirin Tablets Tablets Aspirin 81 Mg Asia Pharmaceutical Industries,

Aleppo, Syria

7-Apr-09

H2009/20309/286 Cardispirin Dispersible

Tablets

Tablets Aspirin Bp 75mg Cosmos Ltd; Kenya 28-May-09

H2008/13248/782 Chelated Iron Tablets Tablets Iron Glycinate Equivalent To Iron

25mg

Gnld International, Spartan

Manufactured By Nfi, 2125

American Ave, Hayward, Ca,

Usa

7-Apr-09

H2008/18490/467 Clopidogrel Tablets Tablets Clopidogrel Bisulfate Usp

Equivalent To Clopidogrel 75mg


H2008/19701/724 Eazipirin Tablets Tablets Aspirin Usp 75mg Metro Pharmaceuticals

Manufactured By Unique

Remedies Ltd

7-Apr-09

H2009/20250/595 Explat Tablets Tablets Clopidogrel 75mg Indus Pharma 8-Sep-09

H2009/19416/596 Fecontin-F Tablets Tablets Ferrous Glycine Sulphate

Equivalent To 100mg Ferrous Iron

Modi-Mundipharma Pvt. Ltd;

India

8-Sep-09

H2009/19311/622 Ferrose Injection Injection Iron Sucrose Usp 50mg/2.5ml Prism Life Sciences 15-Sep-09

H2009/20914/590 Haemoferon Im/Iv

Injection

Injection Iron Dextran Equivalent To

Elemental Iron 50mg Per Ml

Shreya 3-Sep-09

H2009/20249/651 Indofer 50mg/5ml

Syrup

Syrup Iron (Iii) Hydroxide Polymaltose

Equivalent To Iron 50mg Per 5ml

Indus Pharma Ltd 29-Sep-09

H2009/20964/636 Lomoh-60 Injection Injection Enoxaparin Sodium Injection

Ph.Eur. 60mg

Emcure Pharmaceuticals Ltd 17-Sep-09

H2009/18368/053 Mcbm-69 Tablets Tablets Methylcobalamin 500mcg,

Pyridoxine Hydrochloride Bp

10mg, Folic Acid Bp 5mg

Indoco Remedies Ltd, India 7-Apr-09


220


Registration

H2008/16598/761 Mck-E Injection 2ml Injection Etamsylate Bp 125mg Per Ml Lincoln Ppharmaceuticals 7-Apr-09

H2008/19614/410 Mircera 50mcg/0.3ml

Injection

Injection Methoxy Polyethylene Glucol-

Epoetin Beta/Methoxy

Polyethylene Glycol-Epoetin Beta

50 Micrograms/0.3ml

Roche 7-Apr-09

H2008/19615/411 Mircera 75mcg/0.3ml

Injection

Injection Methoxy Polyethylene Glucol-

Epoetin Beta/Methoxy

Polyethylene Glycol-Epoetin Beta

75 Micrograms/0.3ml

Roche 7-Apr-09

H2009/17704/451 Mundel 75mg Tablets Tablets Clopidogrel Bisulfate Usp


Prism Life Sciences Ltd 6-Aug-09

H2008/19513/1020 Norplat-S Tablets Tablets Clopidogrel 75mg, Aspirin Bp

75mg

Getz Pharma 7-Apr-09

H2009/20325/190 Nugrel Tablets Tablets Clopidogrel Bisulphate Usp


Micro Labs Ltd 7-Apr-09

H2009/20367/211 Plavix 300mg Tablets Tablets Clopidogrel Hydrogen Sulfate


Sanofi Aventis; France 7-Apr-09

H2009/20621/338 Pradaxa 110mg

Capsules

Capsules Dabigatran Etexilate 110mg Ingelheim Pharmaceuticals Ltd 6-Aug-09

H2009/20620/339 Pradaxa 75mg Capsules Capsules Dabigatran Etexilate 75mg Ingelheim Pharmaceuticals Ltd 6-Aug-09

H2008/16111/497 Stanfer Tablets Tablets Dried Ferrous Sulphate Bp 200mg

Equivalent To Ferrous Iron 65mg

Nestor Pharmaceuticals 7-Apr-09

H2009/20873/531 Sterile Dopamine

Concentrate Injection

Injection Dopamine Hcl Bp 200mg Per 5ml Martindale 20-Aug-09

H2008/14828/592 Sylate 125mg Injection

(2ml)

Injection Etamsylate Bp 125mg Per Ml Emcure Pharmaceuticals 7-Apr-09

H2009/20307/166 Xarelto 10mg Tablets Tablets Rivaroxaban 10mg Bayer Schering Pharma;

Germany

7-Apr-09

Blood Products & Blood

Substitutes

H2009/20013/442 Enoxarin-40 Injection Injection Enoxaparin Sodium 40mg Emcure Pharmaceuticals Ltd;

India

6-Aug-09

H2009/20014/443 Enoxarin-60 Injection Injection Enoxaparin Sodium 60mg Emcure Pharmaceuticals Ltd;

India

6-Aug-09

H2009/20208/087 Parin E 20mg/0.2ml

Injection

Injection Enoxaparin Sodium Bp 20mg Per

Syringe

Venus Remedies Ltd; India 7-Apr-09

H2008/19659/604 Parin E Injection

40mg/0.4ml

Injection Enoxaparin Sodium Bp 40mg Venus Remedies Limited, Unit

2, Hill Top, Industrial

Estate,Bhatoli Kalan India

7-Apr-09

H2008/19660/605 Parin E Injection

60mg/0.6ml

Injection Enoxaparin Sodium Bp 60mg Venus Remedies Limited, Unit

2, Hill Top, Industrial

Estate,Bhatoli Kalan India

7-Apr-09

Cardiovascular Drugs

H2008/18392/567 Acepril – 5 Tablets Tablets Enalapril Maleate Bp 5 Mg Lab & Allied Ltd; Kenya 7-Apr-09

H2009/20803/433 Adco Bisco 5mg

Tablets

Tablets Bisoprolol Hemifumarate 10mg

Equivalent To Bisoprolol 8.49mg

Adcock Ingram Ltd; South

Africa

6-Aug-09

H2009/20802/432 Adco Bisco 5mg

Tablets

Tablets Bisoprolol Hemifumarate 5mg

Equivalent To Bisoprolol 4.24mg

Adcock Ingram Ltd; South

Africa

6-Aug-09

H2008/18101/388 Advantec Tablets Tablets Candesartan Cilexetil 16 Mg;

Hydrochlorothiazide Usp 12.5 Mg


H2008/16064/1001 Amdip 10 Tablets Tablets Amlodipine Besylate 10mg Aegis Ltd 7-Apr-09

H2008/19583/543 Amlo-Denk 10 Tablets Tablets Amlodipine Mesilate Equivalent

To Amlodipine 10mg

Denk Pharma Gmbh & Co. Kg;

Prinzregenstennstr. 79 81675

Muenchen, Germany Plant:

84529 Tittmoning, Germany

7-Apr-09

H2008/19582/544 Amlo-Denk 5 Tablets Tablets Amlodipine Mesilate Equivalent

To Amlodipine 5mg

Denk Pharma Gmbh & Co. Kg;




7-Apr-09

H2008/19232/389 Amlozaar Tablets Tablets Losartan Potassium Usp 50 Mg;

Amlodipine Besilate Bp

Equivalent To Amlodipine 5 Mg

Micro Labs Limited, 92, Sipcot,

Hosur-635 126, India

7-Apr-09

H2008/18341/637 Amolab-5 Tablets Tablets Amlodipine As Besylate Bp 5mg Lab & Allied Ltd; Kenya 7-Apr-09

H2008/20085/971 Angel-10 Tablets Tablets Amlodipine Besilate Bp 10mg Zest Pharma; India 7-Apr-09

H2008/20092/972 Angel-5 Tablets Tablets Amlodipine Besilate Bp 10mg Zest Pharma; India 7-Apr-09

H2009/19490/205 Angilock 50 Tablets Tablets Losartan Potassium Usp 50mg Square Pharmaceuticals;

Bangladesh

7-Apr-09

H2008/20160/1058 Angisartan-50 Tablets Tablets Losartan Potassium Usp 50mg Plethico Pharmaceuticals, India 7-Apr-09

H2009/20171/253 Angizaar-50 Tablets Tablets Losartan Potassium Usp 50mg Microlabs Ltd 28-May-09

H2009/20050/204 Angizaar-H Tablets Tablets Losartan Potassium 50mg,

Hydrochlorothiazide Usp 12.5mg

Micro Labs Ltd 7-Apr-09

H2008/19162/842 Arb 16 Tablets Tablets Candesartan Cilexetil Inn 16mg Square Pharmaceuticals 7-Apr-09

H2008/19161/578 Arb 8 Tablets Tablets Candesartan Cilexetil Inn 8mg Square Pharmaceuticals,

Bangladesh

7-Apr-09



Registration

H2008/18467/608 Artocip Ez Tablets Tablets Atorvastatin 10mg, Ezetimibe

10mg

Cipla; India 7-Apr-09

H2008/19951/909 Lipiriv 20mg Capsules Capsules Artovastatin Calcium 21.68 Mg

Equivalent To Artovastatin 20mg

Riva Pharma, Nasr City Egypt 7-Apr-09

H2008/18467/954 Artolip Ez Tablets Tablets Atorvastatin 10mg, Ezetimibe

10mg


H2008/20161/1059 Arvaz-20 Tablets Tablets Atorvastatin Calcium Equivalent

To Atorvastatin 20mg

Plethico Pharmaceuticals, India 7-Apr-09

H2009/20975/745 Atacand 32mg Tablets Tablets Candesartan Cilexetil 32 Mg Astra Zeneca 22-Oct-09

H2008/19675/596 Atorfit Ez Tablets Tablets Atorvastatin Calcium Equivalent

To Atorvastatin 10mg; Ezetimibe

10mg



128, India

7-Apr-09

H2009/20667/672 Atorfitam 20 Tablets Tablets Amlodipine 5mg, Atorvastatin

20mg

Ajanta Ltd 2-Dec-09

H2008/20087/974 Atorid-10 Tablets Tablets Atorvastatin Calcium Bp 10mg Zest Pharma; India 7-Apr-09

H2008/20091/975 Atorid-20 Tablets Tablets Atorvastatin Calcium Bp 20mg Zest Pharma; India 7-Apr-09

H2009/18862/91 Atorva 40 Tablets Tablets Atorvastatin Calcium Equivalent

To Atorvastatin 40 Mg

Zydus Medica (A Division Of

Cadila Healthcare Ltd)

7-Apr-09

H2008/18593/507 Auroliza 10 Tablets Tablets Lisinopril Bp 10 Mg Aurobindo Pharma Ltd; Plot



7-Apr-09

H2008/18592/508 Auroliza 5 Tablets Tablets Lisinopril Bp 5 Mg Aurobindo Pharma Ltd; Plot



7-Apr-09

H2008/18505/463 Auroliza-H 10/12.5 Mg

Tablets

Tablets Lisinopril 2h2o Ph. Eur.


Lisinopril 10 Mg;

Hydrochlorthiazide Ph. Eur. 12.5

Mg




7-Apr-09

H2008/19619/575 Avas-20mg Tablets Tablets Atorvastatin Calcium Equivalent

To Atorvastatin 20mg

Micro Labs Ltd, 92, Sipcot

Hosur, 635 126 India

7-Apr-09

H2009/21011/643 Avastatin 40 Tablets Tablets Atorvastatin 40mg Cosmos Ltd 24-Sep-09

H2009/20481/266 Bpmet-Xl 25 Tablets Tablets S (-) Metoprolol Succinate

23.75mg Equivalent To S (-)

Metoprolol Tartrate 25mg

Emcure Pharmaceuticals Ltd;

India

28-May-09

H2009/20480/267 Bpmet-Xl 50 Tablets Tablets S (-) Metoprolol Succinate 47.5mg

Equivalent To S (-) Metoprolol

Tartrate 50mg


India

28-May-09

H2009/20714/511 Cardoplus 50 Tablets Tablets Losartan Potassium Usp 50mg,

Hydrochlorothiazide Usp12.5mg

Eskayef 18-Aug-09

H2009/19817/276 Carvas-6.25 Tablets Tablets Carvedilol Bp 6.25mg Medley Pharmaceuticals 28-May-09

H2009/19792/014 Carvil 12.5 Tablets Tablets Carvedilol Bp 12.5mg Cadila Healthcare Ltd; India 7-Apr-09

H2009/19793/015 Carvil 25 Tablets Tablets Carvedilol Bp 25mg Cadila Healthcare Ltd; India 7-Apr-09

H2009/19791/016 Carvil 6.25 Tablets Tablets Carvedilol Bp 6.25mg Cadila Healthcare Ltd; India 7-Apr-09

H2008/19728/807 Colestrim Tablets Tablets Fenofibrate Bp 160mg Themis Laboratories India For

Mega Life Sciences

7-Apr-09

H2009/19683/280 Corbis 10mg Tablets Tablets Bisoprolol Fumarate Usp

Equivalent To Bisoprolol 10mg

Unichem Laboratories Ltd 28-May-09

H2009/19682/425 Corbis 5mg Tablets Tablets Bisoprolol Fumarate Usp

Equivalent To Bisoprolol 5mg

Medicraft Pharmaceuticals(Pvt)

Ltd

6-Aug-09

H2009/20711/328 Co-Tasmi Tablets Tablets Telmisartan 40mg,

Hydrochlorothiazide Bp 12.5mg

Getz Pharma 6-Aug-09

H2009/20614/359 Coversyl 10mg Tablets Tablets Perindopril Arginine 10mg Sevier 6-Aug-09

H2009/20613/358 Coversyl 5mg Tablets Tablets Perindopril Arginine 5mg Servier 6-Aug-09

H2008/18689/1007 Cresar 40 Mg Tablets Tablets Telmisartan 40 Mg Cipla Ltd 7-Apr-09

H2009/18733/158 Dawadopa 250 Mg

Tablets

Tablets Methyldopa 250 Mg Dawa Ltd; Kenya 7-Apr-09

H2009/20607/361 Digomet-125 Tablets Tablets Digoxin Bp 125mcg Unicure For Metro 6-Aug-09

H2008/19155/1039 Dilcontin Xl 120

Tablets

Tablets Diltiazem Hcl Usp 120mg Modi-Mundipharma Pvt Ltd,

Modipuram-250 110, Up India

7-Apr-09

H2008/19157/1040 Dilcontin Xl 90 Tablets Tablets Diltiazem Hcl Usp 90mg Modi-Mundipharma Pvt Ltd;

India

7-Apr-09

H2008/19580/545 Ena-Denk 10 Tablets Tablets Enalapril Maleate 10mg Denk Pharma Gmbh & Co. Kg;




7-Apr-09

H2008/19581/546 Ena-Denk 20 Tablets Tablets Enalapril Maleate 20mg Denk Pharma Gmbh & Co. Kg;




7-Apr-09

H2008/19692/600 Enalapril-Agio 10mg

Tablets

Tablets Enalapril Maleate Usp 10mg Agio Pharmaceuticals Ltd, T-82,

M.I.D.C. – 400 072, India

7-Apr-09

H2009/17931/308 Enfelo 2.5 Tablets Tablets Felodipine E.P. 2.5mg Aegis 6-Aug-09

H2009/17930/309 Enfelo 5 Tablets Tablets Felodipine E.P. 5mg Aegis 6-Aug-09


222


Registration

H2009/16551/452 Enril 20h Tablets Tablets Enalapril Maleate U.S.P 20mg,

Hydrochlorothiazide U.S.P

12.5mg

Prism Life Sciences Ltd 6-Aug-09

H2008/18949/935 Eurythmic-200 Tablets Tablets Amiodarone Bp 200mg Troikaa Pharmaceuticals Ltd;

India

7-Apr-09

H2008/19565/786 Fenoget 200mg

Capsules

Capsules Fenofibrate Bp 200mg Getz Phama Ltd, 29-30/27,

Karachi, Pakistan

7-Apr-09

H2008/19564/787 Fenoget 67mg Capsules Capsules Fenofibrate Bp 67mg Getz Phama Ltd, 29-30/27,

Karachi, Pakistan

7-Apr-09

H2009/17696/323 Fenolip 200mg

Capsules

Capsules Fenofibrate 200mg Cipla Ltd 6-Aug-09

H2009/20573/367 Ibertan-H Tablets Tablets Irbesartan Usp 150mg,


Unicure Remedies Ltd 7-Apr-09

H2008/19924/1014 Irbetan 150mg Tablets Tablets Ibesartan Usp 150mg Unicure Remedies Ltd 7-Apr-09

H2008/19925/1015 Irbetan 300mg Tablets Tablets Ibesartan Usp 300mg Unicure Remedies Ltd 7-Apr-09

H2009/19695/298 Irinogen 100mg

Injection

Injection Irinotecan Hydrochloride 20mg

Per Ml

Bago Group Bioprofarma S.A. 28-May-09

H2008/18512/471 Kardak 10mg Tablets Tablets Simvastatin Ph. Eur 10 Mg Aurobindo Pharma Ltd; Plot



7-Apr-09




7-Apr-09




7-Apr-09




7-Apr-09

H2009//678 Kardam 10 Tablets Tablets Amlodipine Besilate 10mg Aurobindo Pharma 2-Dec-09

H2008/18595/517 Kardam 5 Tablets Tablets Amlodipine Besilate Ph. Eur.

Equiv. To Amlodipine 5 Mg




7-Apr-09

H2008/18894/701 Limitrol 10/10 Ez

Tablets

Tablets Ezetimibe 10 Mg, Simvastatin

Usp 10 Mg


H2008/18893/702 Limitrol 10/20 Ez

Tablets

Tablets Ezetimibe 10 Mg, Simvastatin

Usp 20 Mg


H2009/20527/498 Lipicon 10 Tablets Tablets Atorvastatin 10mg Eskayef Bangladesh Ltd 4-Aug-09

H2008/18003/571 Lipril 5 Tablets Tablets Lisinopril Anhydrous 5mg Medreich; India 7-Apr-09

H2008/17743/375 Lisace 10 Tablets Tablets Lisinopril Usp10 Mg Cosmos Limited; Kenya 7-Apr-09

H2008/19183/958 Lisoril-10 Tablets Tablets Lisinopril Usp 10mg Ipca Laboratories Ltd, 48,

Kandivli Industrial Estate,

Mumbai 400 067, India

7-Apr-09

H2008/18482/561 Locol 10 Tablets Tablets Atorvastatin Calcium Inn

Equivalent To 10mg Atorvastatin


Bangladesh

7-Apr-09

H2009/19378/131 Lora-Hc Tablets Tablets Losartan Potassium 50mg,

Hydrochlorthiazide 12.5mg


India

7-Apr-09

H2008/20004/876 Lorvas Sr Tablets Tablets Indapamide Ph Eur 1.5mg Torrent Pharmaceuticals, India 7-Apr-09

H2009/20655/690 Lustatin-10 Tablets Tablets Rosuvastatin Calcium Equivalent

To Rosuvastatin 10mg

Cipla Ltd 2-Dec-09

H2009/20606/320 Lustatin-20 Tablets Tablets Rosuvastatin 20mg Cipla Ltd 6-Aug-09

H2008/18814/435 Methyldopa 250 Mg

Tablets

Tablets Methyldopa Bp 250 Mg Caplinpoint Laboratories 86,

Bazullah Road, T. Madras-600

017; India

7-Apr-09

H2009/19156/120 Monocontin Od Tablets Tablets Isosorbide Mononitrate 50mg Modi-Mundipharma Pvt Ltd 7-Apr-09

H2009/20324/349 Nebilong Tablets Tablets Nebivolol 5mg Micro Labs Ltd 6-Aug-09

H2009/20555/403 Nebilong-H Tablets Tablets Nebivolol Hcl 5mg,


Micro Labs Ltd; India 6-Aug-09

H2009/20875/730 Nelgra 100mg Tablets Tablets Sildenafil 100mg Universal Corporation Ltd 2-Dec-09

H2009/20306/563 Nevol 2.5mg Tablets Tablets Nebivilol Hcl Equivalent To

Nebivilol 2.5mg

Medley Pharmaceuticals Ltd 1-Sep-09

H2009/20011/102 Perigard 2mg Tablets Tablets Perindopril Erbumine Bp 2mg Glenmark Pharmaceuticals Ltd;

India

7-Apr-09

H2009/20012/103 Perigard 4mg Tablets Tablets Perindopril Erbumine Bp 4mg Glenmark Pharmaceuticals Ltd;

India

7-Apr-09

H2009/20010/182 Perigard-D Tablets Tablets Perindopril 3mg, Indapamide Usp

0.65mg

Glenmark Pharmaceuticals 7-Apr-09

H2009/20588/688 Perigard-Df Tablets Tablets Perindopril Erbmine Bp 4mg

Equivalent To Perindopril

3.338mg, Indapamide Usp 1.25mg

Glenmark Pharmaceuticals Ltd;

India

29-Sep-09

H2009/19179/275 Presartan H 50 Tablets Tablets Losartan Potassium Usp 50mg,


Ipca Laboartories Ltd 28-May-09

H2009/20304/572 Primodil 5mg Tablets Tablets Amlodipine Besylate Bp

Equivalent To Amlodipine 5mg




Registration

H2009/18196/104 Primodil-At Tablets Tablets Amlodipine Besylate Bp


Medley Pharmaceuticals 7-Apr-09

H2008/18215/450 Ramitas 2.5 Capsules Capsules Ramipril Bp 2.5mg Intas Pharmaceuticals Ltd; India 7-Apr-09

H2008/18210/451 Ramitas 5 Capsules Capsules Ramipril Bp 5mg Intas Pharmaceuticals Ltd; India 7-Apr-09

H2009/21035/664 Rasilez Hct

150mg/12.5mg Tablets

Tablets Aliskiren 150mg,

Hydrochlorothiazide 12.5mg

Novartis Farma S.P.A. Italy For

Novartis Pharma Ag;

Switzerland

1-Oct-09


150mg/25mg Tablets


Hydrochlorothiazide 25mg


Novartis Pharma Ag;

Switzerland

1-Oct-09


300mg/12.5mg Tablets




Novartis Pharma Ag; Swiss

1-Oct-09

H2008/20086/989 Reten-100 Tablets Tablets Atenolol Bp 100mg Zest Pharma; India 7-Apr-09

H2008/20090/990 Reten-50 Tablets Tablets Atenolol Bp 50mg Zest Pharma; India 7-Apr-09

H2008/19180/869 Revelol Xl 25 Tablets Tablets Metoprolol Succinate Usp

23.75mg Equivalent To


Ipca Laboartories Ltd 7-Apr-09

H2008/19181/870 Revelol Xl 50 Tablets Tablets Metoprolol Succinate Usp



Ipca Laboartories Ltd 7-Apr-09

H2008/19882/776 Rivasc 5mg Capsules Capsules Amlodipine Besylate Equivalent

To Amlodipine 5mg

Riva Pharma S.A.E.; Free Zone

Nasr City, Egypt.

7-Apr-09

H2008/19494/490 Rosuva 10 Mg Tablets Tablets Rosuvastatin 10 Mg Square Pharmaceuticals Ltd;


Bangladesh

7-Apr-09

H2009/18904/655 S-Amlosafe 2.5 Tablets Tablets S (-) Amlodipine Besilate

Equivalent To S (-) Amlodipine

2.5mg

Aristo Pharmaceuticals Ltd.,

India

29-Sep-09

H2009/18905/656 S-Amlosafe 5 Tablets Tablets S (-) Amlodipine Besilate

Equivalent To S (-) Amlodipine

5mg

Aristo Pharmaceuticals Ltd.,

India

29-Sep-09

H2008/19578/549 Simva-Denk 20 Tablets Tablets Simvastatin 20mg Denk Pharma Gmbh & Co. Kg;




7-Apr-09

H2008/19579/550 Simva-Denk 40 Tablets Tablets Simvastatin 40mg Denk Pharma Gmbh & Co. Kg;




7-Apr-09

H2009/20522/502 S-Numlo 10mg Tablets Tablets S (-) Amlodipine Besylate



India

4-Aug-09

H2009/20521/503 S-Numlo 5mg Tablets Tablets S (-) Amlodipine Besylate



India

4-Aug-09

H2009/20231/336 Stiloz-100 Tablets Tablets Cilostazol 100mg Glenmark Pharmaceuticals 6-Aug-09

H2009/20230/337 Stiloz-50 Tablets Tablets Cilostazol 50mg Glenmark Pharmaceuticals 6-Aug-09

H2009/20550/333 Tasmi 20mg Tablets Tablets Telmisartan 20mg Getz Pharma 7-Apr-09



H2009/20501/574 Telmi 40h Tablets Tablets Telmisartan 40mg;


Prism Life Sciences Ltd 1-Sep-09

H2008/20127/1027 Telmi 40mg Tablets Tablets Telmisartan 40mg Prism Life Sciences Ltd 7-Apr-09

H2009/20500/575 Telmi 80h Tablets Tablets Telmisartan 80mg,


Prism Life Sciences Ltd 1-Sep-09

H2008/20128/1028 Telmi 80mg Tablets Tablets Telmisartan 80mg Prism Life Sciences Ltd 7-Apr-09

H2008/18425/536 Teltas 80 Tablets Tablets Telmisartan 80mg Intas Pharmaceuticals Ltd; India 7-Apr-09

H2009/20579/441 Telzart-H Tablets Tablets Telmisartan 40mg,



H2008/18896/709 Treatan 8 Mg Tablets Tablets Candesartan Cilexetil 8 Mg Pharmevo Pvt Ltd 7-Apr-09

H2009/20818/438 Tritace 10mg Tablets Tablets Ramipril 10mg Sanofi Aventis 6-Aug-09

H2009/20827/581 Unitel-80 Tablets Tablets Telmisartan 80mg Corona Remedies 1-Sep-09

H2009/20828/689 Unitel-H 40 Tablets Tablets Telmisartan 40mg;

Hydrochlorthiazide Bp 12.5mg

Corona Remedies 22-Oct-09

H2009/20826/613 Unitel-H 80 Tablets Tablets Telmisartan 80mg;

Hydrochlorthiazide Bp 12.5mg

Corona Remedies 8-Sep-09

H2008/18043/381 Vastor 20-Ez Tablets Tablets Ezetimibe 10 Mg; Atorvastatin

Calcium Equivalent To

Atorvastatin 20 Mg

Aurochem Laboratories 7-Apr-09

H2009/20917/591 Vidol 12.5mg Tablets Tablets Carvedilol Bp 12.5mg Cosmos Ltd 3-Sep-09

H2009/20918/592 Vidol 25mg Tablets Tablets Carvedilol Bp 25mg Cosmos Ltd 3-Sep-09

H2009/20916/593 Vidol 6.25mg Tablets Tablets Carvedilol Bp 6.25mg Cosmos Ltd 3-Sep-09

H2008/18774/439 X-Plended 10 Mg

Tablets

Tablets Rosuvastatin Calcium Equivalent

To Rosuvastatin 10 Mg

Pharma Evo (Pvt) Ltd; Plot # A-

29, North Western; Industrial

Zone, Port Karachi-75020,

Pakistan

7-Apr-09


224


Registration

H2008/18775/428 X-Plended 5 Mg

Tablets

Tablets Rosuvastatin Calcium Equivalent

To Rosuvastatin 5 Mg

Pharma Evo (Pvt) Ltd; Plot # A-

29, North Western; Industrial

Zone, Port Karachi-75020,

Pakistan

7-Apr-09

H2009/16542/188 Ziak 2.5/6.25mg

Tablets

Tablets Bisoprolol Fumarate 2.5mg,


Merck Ltd 7-Apr-09

H2008/18887/711 Zylatan H Tablets Tablets Losartan Potassium Usp 50 Mg,

Hydrochlorthaizide Usp 12.5 Mg

Triokaa Pharmaceuticals Ltd,

Thol – 382 728, Gujarat, India

7-Apr-09

Dermatological Drugs

H2008/19136/538 Aciherpin 5 %W/W

Cream

Cream Acyclovir Ip 5 % W/W Agio Pharmaceuticals Ltd, T –

82, M.Id.C., Bhosari, Pune 411

026, India

7-Apr-09

H2008/15462/999 Albican Dusting

Powder (75g)

Topical

Powder

Clotrimazole Bp 1% W/W Cipla Ltd 7-Apr-09

H2009/20245/325 Antihistamine Cream Topical Cream Mepyramine Maleate Bp 2%

W/W

Elys Chemicals Ltd 6-Aug-09

H2009/19822/422 Axcel Fusi-Corte

Cream

Cream Fusidic Acid 2% W/W,

Betamethasone 17-Valerate 0.1%


H2009/19821/340 Axcel Fusidic Cream Topical Cream Fusidic Acid 2% W/W Kotra Pharma-Malaysia 6-Aug-09

H2008/20023/976 Azonit 1% Vaginal

Cream

Cream Isoconazole Nitrate Bp 10mg/Gm Pharma International Co. 7-Apr-09

H2008/20131/1002 Benasten Cream Cream Betamethasone 0.05%W/W,

Clotrimazole Bp 1% W/W

Benmed, Kenya 7-Apr-09

H2008/19381/511 Beticort Ointment Ointment Betamethasone Bp 0.1% W/W Per

15 Gram

Essential Pharmaceuticals, P.O

Box 18237, Nairobi Kenya

7-Apr-09

H2008/19219/879 Blue Cap Cream Cream Glycyrrhizic Acid 1.9% Catalysis, Macarena, 14 28016,

Spain

7-Apr-09

H2009/20514/283 Brevoxyl Cream Cream Benzoyl Peroxide 4gm Per 100gm Stiefel Laboratories Ltd; South

Africa

28-May-09

H2008/19799/686 Capsifenac Gel Topical Gel Capsaicin 0.025% , Diclofenac

Diethylamine Bp 1.16%,

Racementhol Bp 1%, Methyl

Salicylate Bp 3% Per 20g

Prisma Pharmaceuticals 7-Apr-09

H2009/19647/295 Clobederm Ointment Ointment Clobestasol Propionate Usp 0.05%

W/W

Atco Laboratories 28-May-09

H2009/19538/117 Clo-Sol Cream (15gm) Cream Clobetasol Propionate Bp

0.05%W/W


India

7-Apr-09

H2008/19246/880 Clotisone Cream Cream Clotrimazole Bp 1%W/W Pmc For Essential

Pharmaceuticals Ltd, Industrial

Area Nairobi; Kenya

7-Apr-09

H2009/18692/667 Dapalen Gel Topical Gel Adapalene 0.1 % W/W Per Tube Dwd Pharmaceuticals Ltd 6-Oct-09

H2009/20349/697 Dawavate Cream Cream Betamethasone Valerate Bp 0.1%

W/V

Dawa Ltd 2-Dec-09

H2009/19997/698 Dawavate G Ointment Ointment Betamethasone Valerate Bp 0.1%

W/V, Gentamicin Sulfate Bp 0.1%

W/V

Dawa Ltd 2-Dec-09

H2009/20439/513 Deriva Aqueous Gel Topical Gel Adapalene 0.1% W/W Per 15g Glenmark Pharmaceuticals 18-Aug-09

H2009/20270/152 Dermazine Plus Cream Cream Silver Sulphadiazine Usp

1%W/W, Chlorhexidine

Gluconate 0.2%W/W


H2008/19575/640 Drez Ointment 10g Ointment Iodinated- Povidone Bp 5%W/V,

Metronidazole Bp 1%W/V Per

10gm

Stedman Pharmaceuticals

Private Ltd, C-4, Sidco

Pharmaceutical Complex,

Alathur, Thiruporur- 603 110,

Tamilnadu, India

7-Apr-09

H2008/19574/641 Drez Solution Topical

Solution

Iodinated- Povidone Bp 5%W/V,

Metronidazole Bp 1%W/V Per

30ml





Tamilnadu, India

7-Apr-09

H2008/20009/873 Elovera Cream Cream Aloe Extract 10%, Vitamin E

0.5% Per 100gm

Glenmark Pharmaceuticals,

India

7-Apr-09

H2008/19497/499 Equra 10% Cream Cream Urea Bp 100mg Per Gram Square Pharmaceuticals Ltd.,


Bangladesh

7-Apr-09

H2009/20129/110 Evra Transdermal

Patches

Transdermal

Patches

Norelgestromin 150mcg,

Ethnylestradiol 20mcg Per Patch

Janssen-Cilag 7-Apr-09

H2009/20713/444 Facid Hc Cream Cream Fusidic Acid Bp 20mg;

Hydrocortisone 10mg Per Gram

Eskayef; Bangladesh 6-Aug-09

H2009/20487/265 Flucos Lotion Topical Lotion Fluconazole Usp 2%W/V, Zinc

Pyrithione (Zpto) 1%W/V

Cosme Pharma Ltd; India 28-May-09

H2008/18744A/516 Fusifen Ointment Ointment Sodium Fusidate Bp Equivalent

To Anhydrous Fusidic Acid 2 %

W/W

Fourrts (India) Laboratories Ltd;

Plot # 1, Fourrts Avenue,

Okkiyam Thoraipakkam, Annai

7-Apr-09



Registration

Indira Nagar, Chennai – 600

097, India

H2008/18996/470 Fusigen Ointment Ointment Sodium Fusidate Bp 20 Mg Per

Gram

Geno Pharmaceuticals Ltd,

Mapusa, Goa, 403 507, India

7-Apr-09

H2009/20590/729 Germskutter Ointment Ointment Salicylic 1.428gm, Benzoic Acid

0.294gm

Universal Corporation Ltd 2-Dec-09

H2008/19737/651 Healace Gel Topical Gel Recombinant Human Platelet

Derived Growth Factor 0.01%

Virchow Biotech Pvt, Survey

No. 172 Part, Gagillapur,

Qutubullapur, R.R District, Ap,

India

7-Apr-09

H2008/19427/643 Hyrosone Cream Cream Hydrocortisone 1% Per 10gm Pmc For Essential

Pharmaceuticals Ltd; P.O. Box

18237 Nairobi; Kenya

7-Apr-09

H2008/19424/458 Ionsil Gel Topical Gel Silver Nitrate Gel 0.2% Per 15gm Virchow Biotech Ltd, Survey

No. 172 Part, Gagillapur

Village, India

7-Apr-09

H2009/11713/521 Iruxol Mono Ointment

(10, 30g)

Ointment Collagenase Clostriopeptidase A

1.2 Units, Proteases 0.24 Units Per

G

Smith & Nephew (Pty) Ltd 18-Aug-09

H2009/20513/284 Isotrex Gel Topical Gel Isotretinoin 0.05gm Per 100gm Stiefel Laboratories Ltd; South

Africa

28-May-09

H2008/19234/539 Kemzid Cream Cream Triamcinolone Acetonide 15mg

(0.1%W/W)

Unison Laboratories Co., Ltd,

Thailand For Omaera


7-Apr-09

H2008/19788/663 Kenazole Cream Cream Ketoconazole Usp 20mg Per Gm Pharma International Co. Ltd,

Amman, Jordan

7-Apr-09

H2009/20362/305 Kensten 1% Cream Cream Clotrimazole Bp 10mg Per Gram Square Pharmaceuticals Ltd;

Bangladesh

28-May-09

H2008/15516/755 Konazol Cream 15gm Cream Ketoconazole 2.0%W/W Lincoln Pharmaceuticals 7-Apr-09

H2009/20436/227 Lolita 2.5% Topical

Gel

Topical Gel Ketoprofen 2.5gm Per 100gm Omaera Pharmaceuticals Ltd 28-May-09

H2009/20204/607 Lysoflam Topical Gel Topical Gel Diclofenac Diethylamine Bp

1.116% W/W; Methyl Salicylate

Usp 12.0 % W/W; Menthol Usp

5.0 %W/W


India – Manufacturer Indchemie

Health Specialties Ltd; India

8-Sep-09

H2008/19423/459 Micoson 2% Cream Cream Miconazole Nitrate 2% Per 15gm Agio Pharmaceuticals Ltd, A-

38, Nandjyot Industrial Estate,

Kuria-Andheri Road, Safepool,

Mumbai-400 072 India

7-Apr-09

H2009/19584/237 Monsin Ointment Ointment Mupirocin Usp 20mg Per Gram Ranbaxy 28-May-09

H2009/18690/676 Mupicin Ointment Ointment Mupirocin Usp 2 % W/W Dwd Pharmaceuticals 6-Oct-09

H/2009/20355/303 Mycofin Cream Cream Terbinafine Hydrochloride

1%W/W

Eskayef; Bangladesh 28-May-09

H2008/8438/533 Nebagin Powder 10gm Topical

Powder

Neogracin Sulphate B.P 5mg;

Bacitracin Zinc B.P 2.5mg;

Gramicidin –D Usp 0.5mg

Biodeal Laboratories Ltd;

Kenya

7-Apr-09

H2009/19687/560 Nelcort Ointment Ointment Hydrocortisone Acetate Bp

1.0%W/W


Kenya

1-Sep-09

H2008/18758/888 Norash Cream Cream Dimethicone Bpc 20%W/W, Zinc

Oxide Bp 7.5% W/W, Calamine

Bp 1.5% W/W, Cetrimide Bp

1.125% W/W

Reptakos, Brett & Co. Ltd, India 7-Apr-09

H2008/20025/898 Optimal 0.05% Cream Cream Tretinoin Usp 0.5mg/1gm Pharma International Amman 7-Apr-09

H2008/18716/949 Pil-O-Cure Ointment Ointment Beclomethasone Dipropionate

Usp 0.025 % W/W, Lignocaine

Hydrochloride Usp 2.5 % W/W,

Phenylephrine Hydrochloride Bp

0.10 % W/W Per Gram

Nexgen Healthcare 7-Apr-09

H2009/20690/316 Podosal Ointment Topical

Ointment

Podophyllum Resin Bp 20% Biodeal Laboratories Ltd 6-Aug-09

H2008/18580/401 Remus Ointment Ointment Tacrolimus Inn 0.3 Mg/Gm Square Pharmaceuticals 7-Apr-09

H2009/20073/278 Silverkant Cream Cream Silver Sulfadiazine Usp 1%W/W S Kant Healthcare Ltd 28-May-09

H2008/19227/576 Sonapen Spray Topical Spray Oil Of Wintergreen 15.0%W/W,

Pudina Ka Phool 5.0%W/W,

Turpentine Oil 3.0%W/W, Nilgiri

Ka Tel 2.0%W/W, Cinnamon Oil

0.4%W/W

Parnax Lab Pvt. Ltd., M-163,

M.I.D.C., Waluj Aurangabad-

431136, For Sonal Holdings (K)

Ltd

7-Apr-09

H2009/20232/113 Supirocin-B Ointment Ointment Mupirocin Usp 2%,

Betamethasone Dipropionate Usp

0.05% Per 5g


India

7-Apr-09

H2008/19328/437 Terbized 1% Cream Cream Terbinafine Hydrochloride B.P

1%W/W

Agio Pharm. Ltd 7-Apr-09

H2008/19363/708 Termider 1% Cream Cream Terbinafine Hcl 10mg Per Gram Biopharma Laboratories

Limited, Tongi, Bangladesh

7-Apr-09


226


Registration

H2008/20024/900 Topidic (2%) Ointment Ointment Sodium Fusidate Bp 20mg/1gm Pharma International Amman 7-Apr-09

H2009/20811/580 Trimicon Cream Cream Miconazole 2% Per Ml Unison Laboratories Co., Ltd,

Thailand For Omaera


1-Sep-09

H2008/19247/685 Whitfield Ointment Ointment Benzoic Acid Bp 6% W/W,

Salicylic Acid Bp 3% W/W Per

25g

Pmc For Essential

Pharmaceuticals Ltd, Industrial

Area Nairobi, Kenya

7-Apr-09

H2009/9238/390 Whitfield’s Ointment

(15g)

Ointment Salicylic Acid Bp 3%, Benzoic

Acid Bp 6%

Gesto Pharmaceuticals Ltd;

Kenya

6-Aug-09

H2009/18691/685 Zynex Cream Cream Fusidic Acid Bp Equivalent To

Anhydrous Fusidic Acid 20 Mg

Per Gram

Dwd Pharmaceuticals Ltd 6-Oct-09

Diagnostics Agents (Radiologicals)

H2009/20222/455 Contrapaque 350mg

Injection

Injection Iohexol Usp 755mg Equivalent To

Iodine 350mg Per Ml

Unique Pharmaceuticals Ltd;

India

6-Aug-09

H2009/18759/516 Doutrav Eye Drops

Solution

Eye Drops Travoprost 40 Micrograms,

Timolol 5mg Per Ml

Alcon - Couvreur 18-Aug-09

H2009/18759/549 Duotrav Eye Drops Eye Drops Travoprost 0.04mg, Timolol (As

Timolol Maleate) 5mg

Sa Alcon-Couvreur Nv;

Belgium

1-Sep-09

H2009/20644/689 Lefumide 20 Tablets Tablets Leflunomide 20mg Cipla Ltd 2-Dec-09

H2009/20046/727 Pamidol 370 Injection Injection Iopamidol Usp 755.3mg Unique Pharmaceuticals Ltd 2-Dec-09

H2008/18724/906 Scanlux 300mg/Ml

Injection

Injection Iopamidol 612 Mg Equivalent To

Iodine 300 Mg Per Ml

Sanochemia 7-Apr-09

H2008/18725/907 Scanlux 370 Mg/Ml

Injection

Injection Iopamidol 755 Mg Equivalent To

Iodine 370 Mg Per Ml

Sanochemia 7-Apr-09

Disinfectants & Antiseptics

H2008/19539/830 Chlorhexidine

Gluconate 5 % Solution

Solution Chlorhexidine Gluconate Solution

Bp 25 % W/V Equivalent To

Chlorhexidine Gluconate 5 %

W/V

Sirmaxo Chemicals Plot E-

35,Tarapur, Midc, Boisar, Dist,

Thane, Maharashtra State, India

7-Apr-09

H2008/19689/1004 Chlorhexidine

Gluconate 5%V/V

Antiseptic Solution

Solution Chlorhexidine Gluconate 5%V/V Universal Corporation Ltd 7-Apr-09

H2009/20034/594 Dawadine Mouthwash

& Gargle

Mouthwash Povidone Iodine Usp 1%W/V Dawa Ltd; Kenya 8-Sep-09

H2008/14877/1008 Dermobacter Foaming

Solution (125ml)

Topical

Solution

Benzalkonium Chloride 0.500gm,

Chlorhexidine Digluconate

0.200gm Per 100ml

Innotech Int. 7-Apr-09

H2009/20432/229 Drez Powder Oral Powder Iodinated-Povidone Bp 5.0%

W/W, Metronidazole Bp

1.0%W/W

Stedman Pharmaceuticals Ltd 28-May-09

H2009/18485/055 Quadrajel 15g Gel Oral Gel Chlorhexidine Gluconate Solution

Bp Equivalent To Chlorhexidine

Gluconate 1% W/W,

Metronidazole Benzoate Bp

Equivalent To Metronidazole 1%

W/W, Lidocaine Hydrochloride

Bp Equivalent To Anhydrous

Lidocaine Hydrochloride 2%

W/W Per 15gm

Fourrts 7-Apr-09

H2008/19541/837 Saniquad Ghs Solution Solution Chlorhexidine Gluconate Solution

Bp Equivalent To Chlorhexidine

Gluconate 1.5 % W/V, Cetrimide

Solution Bp Equivalent To

Cetrimide Bp 15 % W/V




7-Apr-09

H2008/19543/991 Saniquad M 20

Solution

Solution Chlorhexidine Gluconate Solution

Bp 20% V/V

Sirmaxo Chemicals Pvt. 7-Apr-09

H2008/19540/838 Saniquad Pvp T

Solution

Solution Povidone Iodine Usp 10 % W/V

Equivalent To Available Iodine

1% W/V




7-Apr-09

H2008/19542/839 Saniscrub E Solution Solution Chlorhexidine Gluconate Solution

Bp 2.5 % W/V Equivalent To

Chlorhexidine Gluconate 0.5 %

W/V, Ethanol 70 % W/V




7-Apr-09

H2009/20333/191 Septadine Oral

Antiseptic

Mouthwash Povidone Iodine 0.1%M/V Per

100ml

Be-Tabs Pharmaceuticals 7-Apr-09

H2008/19073/380 Tbcide Solution Solution Stabilized Sodium Hypochlorite 5

% W/V

Kenya Medical Research

Institute, P.O. Box 54840 –

00200 Nairobi

7-Apr-09

Diuretics

H2008/18342/955 Captolab-25 Tablets Tablets Captopril Usp 25mg Lab & Allied 7-Apr-09

H2008/19508/655 Diuride-10 Tablets Tablets Torsemide Usp 10mg Saga Laboratories Ltd 7-Apr-09

H2008/19507/614 Diuride-100 Tablets Tablets Torsemide Usp 100mg Saga Laboratories Ltd., Plot No.

1409, Phase Iii G.I.D.C., Estate,

7-Apr-09



Registration

Vatwa, Ahmedabad – 382 445,

India

H2008/19506/615 Diuride-20 Tablets Tablets Torsemide Usp 20mg Saga Laboratories Ltd., Plot No.



India

7-Apr-09

H2008/19467/513 Fruselactone 20/100

Tablets

Tablets Frusemide Bp 20 Mg;

Spironolactone Bp 100 Mg




India

7-Apr-09

H2008/19466/514 Fruselactone 20/50

Tablets

Tablets Frusemide Bp 20 Mg;

Spironolactone Bp 50 Mg




India

7-Apr-09

H2009/20560/293 Frusin 40mg Tablets Tablets Furosemide Bp 40mg Aurochem Lab Ltd; India For


28-May-09

H2008/19165/618 Fusid Injection Injection Frusemide Bp 20mg Per 2ml

Ampoule



Bangladesh

7-Apr-09

H2008/19166/421 Fusid Tablets Tablets Frusemide Bp 40 Mg Square Pharmaceuticals,

Bangladesh

7-Apr-09

H2009/19414/602 Indicontin Tablets Tablets Indapamide Usp 1.5mg (In A

Controlled Release System)

Modi-Mundipharma Pvt. Ltd;

India

8-Sep-09

H2008/19477/487 Metoz 2.5 Mg Tablets Tablets Metolazone Usp 2.5 Mg Centaur Pharmaceuticals Ltd;

Karaswada, Mapusa, Goa 403

526; India

7-Apr-09

H2008/19478/793 Metoz 5 Tablets Tablets Metolazone Usp 5mg Centaur Pharmaceuticals Pvt.

Ltd., Karaswada, Mapusa, Goa-

403 526. India

7-Apr-09

H2009/20217/088 Temodal 100mg

Capsules

Capsules Temozolomide 100mg Schering Plough 7-Apr-09

H2009/20218/114 Temodal 20mg

Capsules

Capsules Temozolomide 20mg Schering Plough; Usa;

Manufactured By Orion Pharma

Finland

7-Apr-09

H2009/20216/089 Temodal 250mg

Capsules

Capsules Temozolomide 250mg Schering Plough 7-Apr-09

H2009/20217/115 Temodal 5mg Capsules Capsules Temozolomide 5mg Schering Plough; Usa;

Manufactured By Orion Pharma

Finland

7-Apr-09

H2009/20301/162 Toras-Denk 5mg

Tablets

Tablets Torasemide 5mg Denk Pharma Gmbh & Co. Kg;

Germany

7-Apr-09

Gastrointestinal Drugs

H2008/18975/505 Acicone-S Suspension Oral

Suspension

Magaldrate 540mg; Simethicone

40mg

Medical Union; Egypt 7-Apr-09

H2009/20167/301 Albendazole

Suspension

Oral

Suspension

Albendazole Usp 200mg Per 5ml Gracure Pharmaceuticals 28-May-09

H2009/20677/701 Albendazole Tablets Tablets Albendazole 200mg Gracure Pharmaceuticals Ltd 2-Dec-09

H2009/19986/049 Albendazole Tablets

400mg

Tablets Albendazole Bp 400mg Sanya Life Sciences, India;

Manufactured By Atra Pharma

Pvt. Ltd; India

7-Apr-09

H2009/20736/686 Algin 50mg Tablets Tablets Tiemonium Methylsulphate 50mg Renata 22-Sep-09

H2008/19163/722 Almex 400 Tablets Tablets Albendazole Usp 400mg Square Pharmaceuticals,

Bangladesh

7-Apr-09

H2008/19304/692 Altoa Suspension Oral

Suspension

Albendazole 10% W/V Lab & Allied 7-Apr-09

H2008/19627/723 Altoa Suspension Oral

Suspension

Albendazole Bp 200mg Per 5ml Lab & Allied; Kenya 7-Apr-09

H2008/19397/1000 Aluvia 100mg/25 Mg

Tablets

Tablets Lopinavir 100 Mg, Ritonavir 25

Mg

Abbott Gmbh & Co. Kg 7-Apr-09

H2009/20666/671 Aprazole Plus-20

Powder For Oral

Suspension

Oral Powder Omeprazole Bp 20mg, Sodium

Bicarbonate Bp 1680mg

Ajanta Ltd 2-Dec-09

H2009//676 Astacid Tablets Tablets Magnesium Trisilicate Bp 120mg Astra Lifecare 2-Dec-09

H2008/19806/805 Benaworm Tablets Tablets Albendazole Usp 200mg Benmed 7-Apr-09

H2009/7574/685 Bendex-400mg Tablets Tablets Albendazole Usp 400mg Cipla Ltd 2-Dec-09

H2009/20967/702 Bisacodyl 5mg Tablets Tablets Bisacodyl 5mg Gracure Pharmaceuticals Ltd 2-Dec-09

H2008/18708/847 Catoxymag-N

Suspension

Oral

Suspension

Dried Aluminium Hydroxide Bp

200mg, Magnesium Trisilicate Bp

200mg, Magnesium Hydroxide Bp

100mg, Sodium Alginate Bp

100mg, Simethicone Usp 25mg

Per 5ml

Enicar Pharmaceuticals Pvt. Ltd 7-Apr-09

H2009/20366/302 Colicon 10mg/ 5ml

Syrup

Syrup Dicycloverine Hcl Bp 10mg Per

5ml


Bangladesh

28-May-09


228


Registration

H2009/20359/304 Colicon Injection Injection Dicycloverine Hci Bp 20 Mg Per

2 Ml


Bangladesh

28-May-09

H2008/19775/660 Compound Magnesium

Trisilicate Tablets

Tablets Magnesium Trisilicate Bp 250mg,

Dried Aluminium Hydroxide Bp

120mg, Peppermint Oil Bp

0.003ml Per Chewable Tablet

Agog Pharma Ltd, Plot # 33,

Sector Ii, The Vasai Taluka Indl.

Coop. Estate Ltd, Vasai (E),

Dist,Thane, India

7-Apr-09

H2009/18552/127 Conlax Anal

Suppositories

Suppositories Bisacodyl Usp 10mg Bliss Gvs Pharma Ltd; India 7-Apr-09

H2009/18551/126 Conlax Anal

Suppositories

Suppositories Bisacodyl Usp 5mg Bliss Gvs Pharma Ltd; India 7-Apr-09

H2008/20106/980 Dawamisole Syrup Syrup Levamisole Hcl Bp Equivalent To

Levamisole 40mg Per 5ml

Dawa Ltd 7-Apr-09

H2008/18546/933 Deflux Suspension Oral

Suspension

Domperidone Bp 5mg Per 5ml Beximco 7-Apr-09

H2009/19573/159 De-Spas Tablets Tablets Dicyclomine Hydrochloride Usp

20mg, Paracetamol Bp 500mg

Stedman Pharmaceuticals 7-Apr-09

H2009/20271/153 Dilcontinxl 180 Tablets Tablets Diltiazem Hcl 180mg Modi-Mundipharma Pvt Ltd 7-Apr-09

H2009/16898/351 Domne-Cr 30mg

Capsules

Capsules Domperidone Bp 30mg Raptakos, Bret & C0. 6-Aug-09

H2009/20824/459 Don-A15 Suppositories Suppositories Domperidone 15mg Acme Laboratories Ltd;

Bangladesh

6-Aug-09

H2009/20185/118 Dopmexx 10mg

Tablets

Tablets Domperidone Bp 10mg Unicure Remedies; India For


7-Apr-09

H2009/17265/728 Duxcospan Plus

Tablets

Tablets Paracetamol B.P 500mg, Hyoscine

Butyl Bromide B.P 10mg

Universal Corporation Ltd 2-Dec-09

H2009/20762/393 Duxcospan Syrup Oral Syrup Hyosine Butyl Bromide 5mg Per

5ml


Kenya

6-Aug-09

H2009/19231/246 Elstop Capsules Capsules Loperamide Hcl Usp 2mg Gracure Pharmaceuticals Ltd;

India

28-May-09

H2008/19972/851 Emitino Injection Injection Ondansetron Hcl Usp 2mg Per Ml Cachet Pharmaceuticals, India 7-Apr-09

H2009/20205/439 Emitino Oral Solution Oral Solution Ondansetron Hcl Usp Equivalent

To Ondansetron 2mg Per 5ml


India

6-Aug-09

H2008/19731/745 Emitino Tablets Tablets Ondansetron 4mg Alkem Laboratories 7-Apr-09

H2008/18420/985 Esop Injection Injection Esomeprazole 40mg Per Vial Swiss Parenterals Pvt, Ltd 7-Apr-09

H2009/18655/171 Esoprazole 20mg

Tablets

Tablets Esomeprazole 20mg Bently & Remington 7-Apr-09

H2009/20353/518 Esoral 20 Tablets Tablets Esomeprazole 20mg Sk+F 18-Aug-09

H2009/20354/519 Esoral 40 Tablets Tablets Esomeprazole 40mg Sk+F 18-Aug-09

H2008/19723/747 Esotac 20mg Tablets Tablets Esomeprazole Inn 20mg Navana Pharmaceutals Ltd, 3/C,

Paltan, Dhaka, Bangladesh

7-Apr-09

H2008/19013/642 Esotid 20 Tablets Tablets Esomeprazole Inn 20mg Opsonin Pharma Limited,

Bangladesh

7-Apr-09

H2009/18542/285 Filmet Suspension Oral

Suspension

Metronidazole 200mg Per Ml Beximco Pharmaceuticals Ltd 28-May-09

H2008/19337/529 Gastro Gel Suspension Oral

Suspension

Aluminium Hydroxide Paste

Equivalent To Dried Aluminium

Hydroxide 225 Mg; Magnesium

Hydroxide Paste Equivalent To

Magnesium Hydroxide 200 Mg;

Simethicone Usp 50 Mg Per 5 Ml

Zest Pharma; India 7-Apr-09

H2009/20893/705 Gracid Capsules Capsules Omeprazole Bp 20mg Gracure Pharmaceuticals Ltd 2-Dec-09

H2009/19790/144 Granid Suspension Oral

Suspension

Ornidazole 125mg Per 5ml Nic Pharma 7-Apr-09

H2009/15677/612 Tibezole 500 Tablets Tablets Ornidazole 500mg Pharaonia Pharmaceuticals 8-Sep-09

H2009/20143/576 Tindaz Tablets 500mg Tablets Tinidazole 500mg Okasa Pharma Pvt. Ltd 1-Sep-09

H2009/20000/247 Grasozole-20 Tablets Tablets Esomeprazole Magnesium

Equivalent To Esomeprazole

20mg

Gracure Pharmaceuticals, India 28-May-09

H2008/18299/531 Immolab Capsules Capsules Loperamide Hcl Bp 2mg Lab & Allied Ltd; Kenya 7-Apr-09

H2008/19499/500 Isovent 200 Tablets Tablets Misoprostol Inn 200mcg Square Pharmaceuticals Ltd.,


Bangladesh

7-Apr-09

H2009/20305/557 Kitpylo-C H. Pylori Kit Kit Lansoprazole 30mg (2 Capsules),

Tinidazole Bp 500mg (2 Tablets),

Clarithromycin Usp 250mg (2

Tablets)


H2008/19108/557 Kontrac 200 Tablets Tablets Misoprostol 200mcg Fourrts Laboratoires India,

Vandalur Road, Kelambakkam-

603 103, Tamil Nadu, India

7-Apr-09

H2009/18116/030 Labtac Injection Injection Ranitidine (As Hydrochloride)

25mg Per Ampoule

Laboratory & Allied; Kenya 7-Apr-09

H2008/18769/570 Lactulac Solution

(1ooml, 200ml)

Oral Solution Lactulose 10g Per 15ml Cosme Pharma Ltd 7-Apr-09



Registration

H2009/19746/719 Lacx Solution Oral Solution Each 15ml Contains Lactuclose

10g

Ochoa Laboratory Ltd 2-Dec-09

H2008/18395/812 Levaworm 40 Mg

Tablets

Tablets Levamisole Bp 40 Mg Biodeal Laboratories Ltd 7-Apr-09

H2008/20060/959 Lomizol-20 Capsules Capsules Omeprazole Bp 20mg Benmed Pharmaceuticals Ltd;

Kenya

7-Apr-09

H2009/20415/224 Mebever Capsules Capsules Mebeverine Hcl Equivalent To

Mebeverine 200mg

Getz Pharma 28-May-09

H2009/18587/559 Meftal-Spas Tablets Tablets Mefenamic Acid Bp 250mg,

Dicyclomine Hcl Bp 10mg

Blue Cross Laboratories 1-Sep-09

H2009/20434/431 Motil Tablets Tablets Domperidone Bp 10mg Unichem Laboratories Ltd 6-Aug-09

H2008/18629/1019 Nelzole – 400 Caplets Tablets Metronidazole Bp 200 Mg Universal Corporation Ltd 7-Apr-09

H2008/19441/658 Neo-Penotran Forte

Vaginal Pessaries

Pessaries Metronidazole 750mg Embil Pharmaceuticals Co Ltd

Istanbul/ Turkey

7-Apr-09

H2008/19159/704 Neotack 150 Tablets Tablets Ranitidine Hcl Usp 150mg Square Pharmaceuticals Ltd 7-Apr-09

H2008/19502/677 Neotack Injection Injection Ranitidine Hcl Usp 55.8mg

Equivalent To Ranitidine 50mg

Per 2ml Ampoule



Bangladesh

7-Apr-09

H2009/20957/616 Nexium 10mg Sachets Oral Sachets Esomeprazole 10mg Per Sachet Astrazeneca 10-Sep-09

H2009/20055/037 Nidagyl Suspension Oral

Suspension

Metronidazole B.P 200mg Per 5ml Oss-Chemie (K) Ltd 7-Apr-09

H2009/20737/721 Normanal 500mg

Tablets

Tablets Diosmin 450mg, Hesperidin 50mg Renata Ltd 2-Dec-09

H2009/19814/343 O2 Tablets Tablets Ofloxacin Usp 200mg, Ornidazole

500mg

Medley Pharmaceuticals 6-Aug-09

H2009/19612/070 Odem 8mg Tablets Tablets Ondansetron 8mg Alkem Laboratories Ltd 7-Apr-09

H2009/20170/466 Olmol Forte Tablets Tablets Secnidazole 1g Benmed Pharmaceuticals 6-Aug-09

H2009/19922/082 Omegut Injection Injection Omeprazole Sodium Equivalent

To Omeprazole 40 Mg Per Ml

Popular Pharmaceuticals Ltd 7-Apr-09

H2009/19984/222 Omeprazole 20mg

Capsules

Capsules Omeprazole Bp 20mg Sanya Lifesciences Ltd;India 28-May-09

H2009/16421/522 Omesec 20 Mg

Capsules

Capsules Omeprazole 20 Mg Per Ml Ccm Pharma For Ici Pakistan

Ltd; Pakistan

18-Aug-09

H2008/18927/1024 Omizec Capsules Capsules Omeprazole Bp 20mg Medreich Labs 7-Apr-09

H2009/19203/405 Osspel Suspension Oral

Suspension

Albendazole 200 Mg Per 5 Ml Osschemie (K) Ltd, P. O. Box

68502 – 00622, Nairobi, Kenya

6-Aug-09

H2008/19143/659 Otisec Tablets Tablets Secnidazole 1gm Cure Quick Pharmaceuticals,

20/3, Hsidc,Karnal-132001

Haryana, India

7-Apr-09

H2008/19813/689 Pan Pure Tablets Tablets Pantoprazole Sodium 20mg Emcure 7-Apr-09

H2008/19841/717 Panopaz 40mg Tablets Tablets Pantoprazole Sodium

Sesquihydrate Equivalent To

Pantoprazole 40mg



7-Apr-09

H2009/20771/416 Pansalve Tablets Tablets S (-) Pantoprazole Sodium

Equivalent To S (-) Pantoprazole

20mg


India

6-Aug-09

H2009/20188/281 Pantomet Tablets Tablets Pantoprazole 40mg Unicure For Metro

Pharmaceuticals

28-May-09

H2009/19517/523 Pantosec Tablets Tablets Pantoprazole Sodium


Pantoprazole 40 Mg


H2008/18162/396 Pantotab 40mg Tablets Tablets Pantoprazole Sodium


Pantoprazole 40 Mg

Micro Labs Ltd, 92, Sipcot,

Hosur-635 126, India

7-Apr-09

H2008/19835/719 Pleom-20 Capsules Capsules Omeprazole Bp20mg (As Enteric

Coated Granules)




7-Apr-09

H2009/19445/471 Prazicide Tablets Tablets Praziquantel Bp 600mg Laboratory And Allied 1-Jul-09

H2008/19609/941 Praziquantel 600mg

Tablets

Tablets Praziquantel Usp 600mg Biodeal Laboratories Ltd ;

Kenya

7-Apr-09

H2009/19779/262 Praziquantel 600mg

Tablets

Tablets Praziquantel Usp 600mg Umedica Laboratories Pvt Ltd,

Plot #221, G.I.D.C., Vapi – 396

195, Gujarat,India

28-May-09

H2009/20831/679 Pregsmile Tablets Tablets Doxylamine Succinate Bp 10mg,

Pyridoxine Hcl Bp 10mg, Folic

Acid Bp 2.5mg

Corona Remedies 6-Oct-09

H2008/19510/541 Promto 10 Mg Tablets Tablets Rabeprazole Sodium 10 Mg Getz Pharma (Pvt) Ltd; 29-


7-Apr-09

H2009/20426/228 Digeacid Suspension Oral

Suspension

Magnesium Trisilicate 500mg,

Aluminium Hydroxide 250mg Per

5ml

Sonal Holdings 28-May-09

H2008/19511/542 Promto 20 Mg Tablets Tablets Rabeprazole Sodium 20 Mg Getz Pharma (Pvt) Ltd; 29-


7-Apr-09


230


Registration

H2009/20718/742 Pylotrip Kit Combi-Kit

Tablets

Lansoprazole 30mg, Amoxycillin

Bp 500mg, Clarithromycin Usp

500mg

Square 2-Dec-09

H2009/19079/235 Rabeto 20 Mg Tablets Tablets Rabeprazole Sodium Equivalent

To Rabeprazole 20 Mg

Flamingo Pharmaceuticals 28-May-09

H2008/18212/863 Rabitas 10 Tablets Tablets Rabeprazole Sodium 10mg Intas Ltd 7-Apr-09

H2008/18211/864 Rabitas 20 Tablets Tablets Rabeprazole Sodium 20mg Intas Ltd 7-Apr-09

H2008/19286/1025 Rancer-150 Tablets Tablets Ranitidine Hcl Bp Equivalent To

Ranitidine 150mg

Sterling Lab 7-Apr-09

H2009/19789/248 Ranitidine Tablets Usp

150mg

Tablets Ranitidine Hcl Usp Equivalent To

Ranitidine 150mg

Gracure Pharmaceuticals, India 28-May-09

H2008/19462/574 Razid 20 Mg Tablets Tablets Rabeprazole Sodium 20 Mg Saga Laboratories; Plot 1409,



India

7-Apr-09

H2008/19505/625 Razid-M Capsules Capsules Rabeprazole Sodium 20mg;

Mosapride Citrate 5mg

Saga Laboratories Ltd., Plot No.



India

7-Apr-09

H2009/20528/680 Ridon Tablets Tablets Domperidone 10mg Eskayef 6-Oct-09

H2009/16978/236 Ripra-20mg Tablets Tablets Rabeprazole Sodium Equivalent

To Rabeprazole 20mg

Ochoa Laboratories 28-May-09

H2009/16978/084 Ripra-20mg Tablets Tablets Rabeprazole Sodium Equivalent

To Rabeprazole 20mg

Ochoa Laboratories Ltd 7-Apr-09

H2008/19663/1026 Seole Tablets Tablets Secnidazole 1gm Unicure Remedies Pvt Ltd 7-Apr-09

H2009/19572/160 Siclomin Suspension Oral

Suspension

Dicyclomine Hydrochloride Usp

10mg, Simethicone Emulsion Usp

Equivalent To Simethicone 40mg

Per 5ml

Stedman Pharmaceuticals 7-Apr-09

H2009/13759/658 Skilax Drops (15ml) Oral Drops Sodium Picosulphate 7.5mg Per

Ml

Highnoon Laboratories Ltd 29-Sep-09

H2009/20311/161 Slenfig-10 Capsules Capsules Sibutramine Hcl Monohydrate

10mg

Torrent Pharmaceuticals 7-Apr-09

H2009/18189/725 Sompraz Iv Injection Injection Esomeprazole 40 Mg Sun Pharmaceuticals 2-Dec-09

H2009/20829/683 Spasmocare Tablets Tablets Drotaverine Hcl 80mg Corona Remedies 6-Oct-09

H2008/20104/952 Stopacid Suspension Oral

Suspension

Aluminium Hydroxide Bp 120mg,

Magnesium Trisilicate Bp 250mg

Per 5ml

Dawa Pharmaceuticals Ltd;

Kenya

7-Apr-09

H2009/20269/154 Stopacid Tablets Tablets Aluminium Hydroxide Bp 120mg,

Magnesium Trisilicate Bp 250mg,

Peppermint Oil Bp 0.003ml


H2008/19067/403 Sucrafil O Gel Oral

Suspension

Sucralfate Usp 1 Gm; Oxetacaine

Bp 20mg Per 10 Ml

Fourrts (India) Labs Pvt. Ltd.,

Vandalur Road, Kelambakkam-

603 103 Tamil Nadu, India

7-Apr-09

H2008/14605/482 Trogyl Plus Suspension

(100ml)

Oral

Suspension

Metronidazole (As

Benzoyloxylate) 200mg;

Diloxanide Furoate 250mg


Kenya

7-Apr-09

H2008/14604/483 Trogyl Tablets 200mg Tablets Metronidazole B.P 200mg Biodeal Laboratories Ltd;

Kenya

7-Apr-09

H2008/19875/977 Benagyl-Df Tablets Tablets Diloxanide Furoate Bp 250mg,

Metronidazole Bp 200mg

Benmed 7-Apr-09

H2009/20132/135 T-Zole Tablets Tablets Tinidazole Bp 500mg Sichuan Kewa Pharmaceuticals

Ltd

7-Apr-09

H2009/19780/504 Unidone Tablets Tablets Domperidone Bp 10mg Pmc Ltd-Kenya 4-Aug-09

H2009/20107/582 Vermout Suspension Oral

Suspension

Mebendazole100mg Per 5ml Dawa Pharmaceuticals 1-Sep-09

H2009/20339/192 Vomitin-30

Suppositories

Suppositories Domperidone Bp 30mg Bliss Gvs Pharma Ltd 7-Apr-09

H2009/20340/193 Vomitn-10

Suppositories

Suppositories Domperidone Bp 10mg Bliss Gvs Pharma Ltd 7-Apr-09

H2009/20688/583 Wombit 400mg Tablets Tablets Albendazole 400mg Biodeal 1-Sep-09

H2009/19999/288 Womnil Suspension Oral

Suspension

Albendazole 200mg Per 5ml Dawa Ltd; Kenya 28-May-09

H2008/19634/577 Wormnil-400mg

Tablets

Tablets Albendazole Usp 400mg Per

Chewable Tablet

Plethico Pharmaceuticals Ltd;



7-Apr-09

H2008/190191/425 Wormpel Suspension Oral

Suspension

Albendazole Usp 200 Mg Per 5

Ml


Roorkee – 247 661, India

7-Apr-09

H2009/20728/375 Zeecid Tablets Tablets Dried Aluminium Hydroxide Gel

Bp120mg, Magnesium Trisilicate

Bp 250mg

Zest Pharma 6-Aug-09

H2009/20533/509 Zentel 400mg Tablets Tablets Albendazole 400mg Glaxosmithkline 4-Aug-09

Hormones, Endocrine Drugs, Contraceptives

H2009/19794/011 Bonmax Tablets Tablets Raloxifene Hcl 60mg Cadila Healthcare Ltd; India 7-Apr-09



Registration

H2009/20799/437 Crinone 8% Vaginal

Gel

Vaginal Gel Progesterone 90mg Per Dose Merck Serono 6-Aug-09

H2009/18730/668 Dawasolone Tablets Tablets Prednisolone Bp 5 Mg Dawa Ltd; Kenya 6-Oct-09

H2009/20484/272 Dazolon 100 Tablets Tablets Danazol Usp 100mg Unicure Remedies Ltd; India 28-May-09

H2009/20485/273 Dazolon 200 Tablets Tablets Danazol Usp 200mg Unicure Remedies Ltd; India 28-May-09

H2009/20582/669 Depo-Pred 80mg/2ml

Injection

Injection Methylprednisolone Acetate 80mg

Per Ampoule

Oubari & Co. Pharma 6-Oct-09

H2009/20738/650 Desolon Tablets Tablets Desogestrel Bp 0.15,

Ethinylestradiol Bp 0.03mg

Renata Ltd 29-Sep-09

H2008/19757/913 Emcon Tablets Tablets Levonorgestrel Usp 750 Mcg Renata Ltd 7-Apr-09

H2009/20793/434 Femara 2.5mg Tablets Tablets Letrozole 2.5mg Norvatis Pharma Ag;

Switzerland

6-Aug-09

H2009/20081/726 Lenor-72 Tablets Tablets Levonorgestrel Bp 0.75mg Unicure Remedies Ltd 2-Dec-09

H2008/19756/916 Letrol Tablets Tablets Letrozole Usp 2.5mg Renata Ltd 7-Apr-09

H2008/18878/675 Letroz 2.5mg Tablets Tablets Letrozole Usp 2.5mg Sun Pharmaceuticals Ind. Ltd.

Surveyno. 214, Government

Industrial Area, Phase Ii,

Silvasa-396 230. (U.T. Dadra

&Nagar Haveli), India

7-Apr-09

H2009/19487/032 Levo-72 Tablets Tablets Levonorgestrel Bp 0.75mg West Coast Pharmaceutical

Works Ltd., Meldi Estate, Near

Prasang Party Plot, Opp. Sola

Bhagwat, Sayona City Road,

Gota, Ahmedabad- 82 481-

India.

7-Apr-09

H2008/20117/969 Levogest Tablets Tablets Levonorgestrel Bp 0.75mg Mediorals Laboratores Pvt. Ltd;

J-4/2, Additional, M.I.D.C,

Satara, 415 004, India

7-Apr-09

H2008/19198/587 Lupride 1 Mg/Ml

Injection

Injection Leuprolide Acetate 1 Mg Per Ml Sun Pharmaceuticals Industries

Ltd, Halol – Baroda, Highway,

Halol – 389 350, Gujarat, India

7-Apr-09

H2009/18954/033 Medroxyprogesterone

Acetate-150 Injection

Injection Medroxyprogesterone Acetate

Usp 150 Mg Per Ml

Star Drugs & Research Ltd 7-Apr-09

H2008/20082/944 Nonorm-P Tablets Tablets Norethisterone Bp 5mg Unicure Remedies Ltd; F-25,

Bidc Estate, Gorwa, Baroda,

390016, India

7-Apr-09

H2009/19086/232 Omnidex 0.5 Mg

Tablets

Tablets Dexamethasone Bp 0.5 Mg Aurochem Laboratories (Pvt)

Ltd

28-May-09

H2009/19086/083 Omnidex 0.5 Mg

Tablets

Tablets Dexamethasone Bp 0.5 Mg Aurochem Laboratories Ltd 7-Apr-09

H2008/19759/922 Ovulet Tablets Tablets Clomiphene Citrate Bp 50mg Renata Ltd 7-Apr-09

H2009/19928/372 Premarin 0.3 Tablets Tablets Conjugated Estrogens 0.3mg Wyeth 6-Aug-09

H2009/19927/373 Premelle Ld Tablets Tablets Conjugated Oestrogens 0.3mg,

Medroxyprogesterone Acetate

1.5mg

Wyeth 6-Aug-09

H2008/19661/820 Tibon Tablets Tablets Tibolone 2.5mg Unicure Remedies Pvt Ltd,

F/25, Bidc Estate, Gorwa, India

7-Apr-09

H2008/19473/773 Zarin Implants Dermal

Implant

Levonogestrel 75mg Per Sub

Dermal Implant

Shanghai Dahua Pharmaceutical

Company Limited, China

7-Apr-09

Immunologicals, Antisera And Vaccines

H2009/20634/619 Botox Injection Injection Botulinum Toxin Type A, Human

Albumin And Sodium Chloride

100units

Allergan Pharmaceuticals 15-Sep-09

H2009/20628/314 Comvac 4-Hb Vaccine Vaccine Diphtheria Toxoid 20lf-25lf,

Tetanus Toxoid 5lf-7.5lf, B.

Pertusis 15ou-20ou, Hbsag(Rdna)

10mcg

Bhort Biotech Ltd 6-Aug-09

H2009/19952/446 Elaxim Injection Injection Recombinant Tissue Plasminogen

Activator 52.5mg Per Vial

Gennova Biopharmaceuticals;

India

6-Aug-09

H2008/19769/774 Eritrogen 4000 Iu

Injection

Injection R-Human Alpha-Erythropoietin

4000 Iu

Bioprofarma S.A.; Group Of

Bago Group; Argentina

7-Apr-09

H2008/20002/874 Erykine 2000iu/1ml

Injection

Injection Recombinant Human

Erythropoietin Alfa 2000 Iu Per

Ml

Intas Pharmaceuticals, India 7-Apr-09

H2008/20003/875 Erykine 4000iu/1ml

Injection

Injection Recombinant Human

Erythropoietin Alfa 4000 Iu Per

Ml

Intas Pharmaceuticals, India 7-Apr-09

H2009/19613/708 Elovac-B Vaccine Vaccine Hepatitis-B Surface Antigen

20mcg

Human Biologicals Institute 2-Dec-09

H2009/20889/600 Haemophillus B

Vaccine

Vaccine Influenza Type B Conjugate

Vaccine Per Vial

Serum Institute Of India 8-Sep-09

H2009/20180/057 Imovax Polio Vaccine Vaccine Poliovirus Type 1, Mahoney

Strain (Inactivated) 40 D-Antigen

Unit, Poliovirus Type 2, Mef-I

Sanofi Pasteur; France 7-Apr-09


232


Registration


Unit, Poliovirus Type 3, Saukett


Unit Per Dose

H2009/20710/329 Insuget 70/30 Injection Injection Human Insulin E.Ph.100iu Getz Pharma 6-Aug-09

H2009/20709/330 Insuget-N Injection Injection Human Insulin E.Ph. 100iu Getz Pharma 6-Aug-09

H2009/20708/331 Insuget-R Injection Injection Human Insulin E.Ph. 100iu Getz Pharma 6-Aug-09

H2009/20368/212 Insuman Basal

100iu/Ml Injection

Injection Human Insulin 100iu Per Ml Sanofi Aventis; Germany 7-Apr-09

H2008/19616/409 Mircera 200mcg/0.3ml

Injection

Injection Epoetin Beta 200 Micrograms Per

0.3 Ml

Roche Diagnostics Gmbh,

Mannheim, Germany

7-Apr-09

H2009/20238/111 Priorix-Tetra Vaccine Vaccine Live Attenuated Measles Virus

103 Ccid50, Live Attenuated

Mumps Virus 104.4 Ccid50, Live

Attenuated Rubella Virus 10

Ccid50, Live Attenuated Varicela

Virus 103.3 Pfu Per Vial


H2008/19847/865 Recosulin Injection Injection Human Recombinant Insulin Usp

100 Iu

Shreya Life Sciences Pvt Ltd 7-Apr-09

H2008/19850/866 Recosulin M30

Injection

Injection Human Recombinant Insulin Usp

100 Iu (30% Regular Neutral

Human Insulin And 70% Isophane

Human Insulin)


H2008/19848/867 Recosulin M50

Injection

Injection Human Recombinant Insulin Usp

100 Iu (50% Regular Neutral

Human Insulin And 50% Isophane

Human Insulin)


H2008/19849/868 Recosulin N Injection Injection Human Recombinant Insulin Usp

100 Iu


H2009/20627/315 Revac-B+ Vaccine Vaccine Purified Hbsag 10mcg Bhort Biotech Ltd 6-Aug-09

H2008/20026/899 Shan 5 Vaccine Injection Diphtheria Toxoid 30iu, Tetanus

Toxoid 60iu, Bordetella Pertussis

4iu, Purified Hepatitis-B Surface

Antigen 10mcg, Purified

Polysaccharide Of Tetanus Toxoid

10mcg Per 0.5ml Dose

Shantha Biotechnics 7-Apr-09

H2009/20028/186 Shantetra Multi Dose

Injection

Injection Diphtheria Toxoid 30iu, Tetanus

Toxoid 60iu, B.Pertussis 4iu, R-

Dna Hepatitis-B Surface Antigen

10mcg Per 0.5ml Vial


H2009/20027/187 Shantetra Single Dose

Injection

Injection Diphtheria Toxoid 30iu, Tetanus

Toxoid 60iu, B.Pertussis 4iu, R-

Dna Hepatitis-B Surface Antigen

10mcg Per 0.5ml Vial


H2009/20418/682 Snake Venom

Antiserum

Injection Equine Immunoglobulin

Fragments F(Ab)2 Against Naja,

Dendrocispis, Bitis And Echis

Venoms Per 10ml

Vins Bioproducts Ltd 6-Oct-09

H2008/18426/480 Speeda Vaccine Injection Freeze Dried Rabies Vaccine ≥2.5

I.U. Per 0.5 Ml

Liaoning Cheng Da Biotech;

China

7-Apr-09

H2008/17452/896 Thymogam I.V

Injection (5ml)

Injection Antithymocyte Globulin (Equine)

250mg Per Vial

Bharat Serum And Vaccines Ltd 7-Apr-09

H2008/19023/726 Uniferon 3 Miu

Injection

Injection Recombinant Human Interferon

Alfa-2b E.Ph 3million Iu


H2008/19022/727 Uniferon 5miu

Injection

Injection Recombinant Human Interferon

Alfa-2b E.Ph 5 Million Iu


H2009/20419/684 Vinrab 1000 Iu

Injection

Injection Equine Antirabies

Immunoglobulins Fragments Not

Less Than 1000iu Per Vial

Vins Bioproducts Ltd 6-Oct-09

Muscle Relaxants

H2009/14539/547 Doloact-Mr Tablets Tablets Chlorzoxazone Usp 250mg,

Diclofenac Potassium 50mg,


Ochoa Laboratories 1-Sep-09

H2008/18609/707 Somadril Tablets Tablets Carisoprodol 200 Mg,

Paracetamol 160 Mg, Caffeine 32

Mg

Minapharm Pharmaceuticals 7-Apr-09

Ophtalmic, Ear Nose And Throat Preparations

H2009/20268/151 Alphagan Purite Eye

Drops

Eye Drops Brimonidine Tartrate 1.5mg/Ml Allergan Pharmaceuticals (Sa)

Ltd

7-Apr-09

H2009/18726/122 Apdrops Dx Eye Drops Eye Drops Moxifloxacin Hydrochloride

Equivalent To Moxifloxacin 5mg,

Dexamethasone Sodium

Phosphate Bp Equivalent To

Dexamethasone Phosphate 1 Mg




Registration

Per Ml

H2009/18601/123 Apdrops Eye Drops Eye Drops Moxifloxacin Hydrochloride

Equivalent To Moxifloxacin 5mg

Per Ml


H2009/19089/243 Atrop 1 % Eye Drops Eye Drops Atropine Sulphate Ip 1 % W/V Aurolab, Aravind Eye Hospital

Laico Building, 72 Kk Salai,

Gandhi Nagar, Madurai – 625

020, India

28-May-09

H2008/19747/647 Avamys Nasal Spray Nasal Spray Fluticasone Furoate 27.5mcg Per

Actuation

Gsk 7-Apr-09

H2009/19648/296 Betaxol Eye Drops Eye Drops Betaxolol Hcl Bp 5.6mg

Equivalent To Betaxolol Base

5mg Per Ml

Atco Laboratories Limited 28-May-09

H2008/8436/526 Boric Acid In Spirit Ear

Drops

Ear Drops Boric Acid 2%W/V; Ethanol B.P

20%V/V Per 10ml


Kenya

7-Apr-09

H2008/18952/466 Bracin Eye Drops Eye Drops Tobramycin Usp 3mg As

Tobramycin Sulphate Per Ml

Atco Laboratories Ltd, B-18,

S.I.T.E. Karachi, Pakistan

7-Apr-09

H2009/20689/737 Clomzole Ear Drops Ear Drops Clotrimazole Bp 1% Per 15ml Biodeal Laboratories 2-Dec-09

H2009/20394/223 Combigan Eye Drops Eye Drops Brimonidine Tartrate 2mg,

Timolol Maleate 5mg Per Ml

Allergan Pharmaceuticals Ltd 28-May-09

H2009/20094/169 Desmopressin Acetate

Nasal Spray

Nasal Spray Desmopressin Acetate 10mcg Per

Spray

Cipla Ltd, India 7-Apr-09

H2009/17187/514 Dexatrol Eye/Ear

Suspension

Eye/Ear Drops Dexamethasone 1mg, Neomycin

(As Sulphate) 3.5mg, Polymyxin-

B-Sulphate 6000 Iu,

Benzalkonium Chloride 0.04mg

E.I.P.I Co. 18-Aug-09

H2008/17197/1009 Dexatrol Eye/Ear

Suspension

Eye/Ear Drops Dexamethasone 1 Mg, Neomycin

(As Sulphate) 3.5 Mg, Polymyxin-

B-Sulphate 6000iu, Benzalkonium

Chloride 0.04 Mg Per Ml

Eyptian Inter. Pharmaceutical

Industries

7-Apr-09

H2008/19468/485 Disowax Ear Drops Ear Drops Docusate Sodium Bp 0.5 % W/V;

Glycerine Water To 100 %


Kenya

7-Apr-09

H2008/19205/748 Eyforex Eye Drops Eye Drops Ofloxacin Usp 3 Mg Per Ml Atco Laboratories Ltd,

Ophthalmic Division, B-18,

S.I.T.E., Karachi, Pakistan

7-Apr-09

H2009/19993/172 Flamar Sterile Eye

Drops

Eye Drops Diclofenac Sodium 1 Mg Per Ml Pt Sanbe Farma 7-Apr-09

H2009/20062/064 Flamergi Eye Drops Eye Drops Naphazoline Hcl 0.25mg;

Pheniramine Maleate 3mg Per Ml

Pt Sanbe Farma Sanbe Vision 7-Apr-09

H2008/19496/617 Flonaspray Nasal Spray Fluticasone Propionate Bp 50mcg

Per Actuation



Bangladesh

7-Apr-09

H2009/20422/226 Floral Sterile

Ophthalmic Suspension

Opthalmic

Suspension

Fluorometholone 1mg Per Ml Helix 28-May-09

H2008/19649/809 Gentacil Eye Drops Eye Drops Gentamicin Base 0.3%W/V (As

Gentamicin Bp)

Atco Laboratories 7-Apr-09

H2009/19480/027 Glucotim 0.5% Eye

Drops

Eye Drops Timolol Maleate Usp Equivalent

To Timolol 0.5%W/V

Centaur 7-Apr-09

H2008/19735/652 Hyopt 10mg/Ml Sterile

Eye Solution

Eye Drops Sodium Hyaluronate Bp 10mg Per

Ml

Virchow Biotech Pvt, Survey

No. 172 Part, Gagillapur,

Qutubullapur, R.R District, Ap,

India

7-Apr-09

H2008/19020/834 Labvir Eye Ointment Eye Ointment Aciclovir Bp 30mg Per Gram Laboratory & Allied 7-Apr-09

H2008/19677/757 Lacoma Eye Drops Eye Drops Latanoprost 50mcg Ajanta Pharma Ltd; Factory: B-


128, India

7-Apr-09

H2008/19679/731 Metaspray Nasal Spray Nasal Spray Mometasone Furoate

Monohydrate Equivalent To

Mometasone Furoate Usp 50mcg


H2008/19259/1021 Novaflox Eye Drops Eye Drops Ciprofloxacin Hcl Equivalent To

Ciprofloxacin 3 Mg Per Ml

Ashford Laboratories Ltd 7-Apr-09

H2008/19375/965 Occumol 0.25% W/V

Eye Drops

Eye Drops Timolol 0.25%W/V Marck; India 7-Apr-09

H2008/19376/966 Occumol 0.5% W/V

Eye Drops

Eye Drops Timolol 0.5%W/V Marck; India 7-Apr-09

H2009/19479/178 Oculast Eye Drops Eye Drops Azelastine Hydrochloride Bp 0.5

Mg Per Ml

Atco Laboratories 7-Apr-09

H2009/19697/233 Otipax Ear Drops Ear Drops Phenazone 4gm, Lidocaine

Hydrochloride 1gm Per 16gm

Biocodex 28-May-09

H2009/19697/299 Otipax Ear Drops Ear Drops Phenazone 4gm, Lidocaine

Hydrochloride 1gm Per 16gm

Biocodex 28-May-09

H2008/19206/765 Polytrol Eye Drops Eye Drops Neomycin Sulphate Bp 6.78 Mg,

Polymyxin B Sulphate Bp 1.15

Mg, Dexamethasone Bp 1.0 Mg

Atco Laboratories Ltd,

Ophthalmic Division, B-18,

S.I.T.E., Karachi, Pakistan

7-Apr-09


234


Registration

Per Ml

H2008/18951/563 Proloxin Eye Drops Eye Drops Ciprofloxacin Hcl Usp 3.5mg

Equivalent To Ciprofloxacin Base

3mg Per Ml

Atco Laboratories Ltd, B-18,

S.I.T.E. Karachi, Pakistan

7-Apr-09

H2009/19646/297 Tml Eye Drops Eye Drops Timolol Maleate Usp 6.83mg

Equivalent To Timolol 5mg Per

Ml

Atco Laboratories Limited 28-May-09

H2008/19270/498 Ulcip – D Eye/Ear

Drops

Eye/Ear Drops Ciprofloxacin Hcl Usp Equivalent

To Ciprofloxacin 0.3 % W/V;

Dexamethasone Usp 0.1 % W/V


H2008/19374/418 Xcipro Eye Drops Eye Drops Ciprofloxacin Hcl 0.3% W/V Marck 7-Apr-09

Oxytocics And Antioxytocics

H2008/19931/826 Cypress Tablets Tablets Cyproterone Acetate Bp 2mg,

Ethinylestradiol 0.035mg

Famy Care Ltd-India 7-Apr-09

H2008/18361/984 Ergometrine Injection Injection Ergometrine Maleate Bp 500mcg

Per Ampoule

Healthcare Pharmaceuticals 7-Apr-09

H2008/19761/914 Giane 35 Tablets Tablets Cyproterone Acetate Bp 2mg,

Ethinylestradiol Bp 0.035mg

Renata Ltd 7-Apr-09

H2009/19870/068 Methylergonovine

Maleate Injection

Injection Methylergonovine Maleate Usp

0.2mg Per Ml

Sandoz 7-Apr-09

H2009/19869/310 Oxitin 10iu Injection Injection Oxytocin Bp 10 Iu Per Ml Aproov International, India 6-Aug-09

H2009/19868/311 Oxitin 5iu Injection Injection Oxytocin Bp 5iu Per Ml Aproov International, India 6-Aug-09

H2009/20723/435 Syntocinon 10iu

Injection

Injection Oxytocin10iu Per Ampoule Norvatis Pharma Ag;

Switzerland

6-Aug-09

H2009/4478/577 Tocinox Injection

5iu/Ml

Injection Oxytocin Bp 5iu Per Ml Geofman 1-Sep-09

Psychotherapeutic Drugs

H2008/19370/778 Amitriptyline 25mg

Tablets

Tablets Amitriptyline Hcl 25mg Biodeal Labs Ltd 7-Apr-09

H2009/19937/482 Amitriptyline 25mg

Tablets

Tablets Amitriptyline Hcl Bp 25mg Universal Corporation Ltd 4-Aug-09

H2009/19230/90 Amitriptylline Tablets Tablets Amitriptyline Hcl Bp 25mg Gracure Pharmaceuticals 7-Apr-09

H2009/20065/259 Braxidin Tablets Tablets Chlordiazepoxide Usp 5mg,

Clinidium Usp 2.5mg

Pt Sanbe Farma; Jl. Industries #

8, Cimareme, Padalang,

Bandung, Indonesia

28-May-09

H2009/20962/633 Cabalin 150mg

Capsules

Capsules Pregabalin 150mg Cachet Pharmaceuticals Ltd 17-Sep-09

H2009/20963/634 Cabalin 25mg Capsules Capsules Pregabalin 25mg Cachet Pharmaceuticals Ltd 17-Sep-09

H2009/20961/635 Cabalin 75mg Capsules Capsules Pregabalin 75mg Cachet Pharmaceuticals Ltd 17-Sep-09

H2009/16316/254 Chlorpromazine

Injection Bp

Injection Chlorpromazine Hydrochloride

Bp 25mg Per Ml

Nestor Pharmaceuticals Ltd 28-May-09

H2009/20358/238 Deprex 5mg Tablets Tablets Olanzapine 5mg Square Pharmaceuticals 28-May-09

H2009/16315/255 Diazepam Injection Bp Injection Diazepam Bp 5mg Per Ml Nestor Pharmaceuticals Ltd 28-May-09

H2009/19982/279 Diazepam Tablets Bp Tablets Diazepam Bp 5mg Sanya Life Sciences, India 28-May-09

H2008/18561/582 Dicorate Er 250 Tablets Tablets Divalproex Sodium Equivalent To

Valproic Acid 250mg

Sun Pharmaceuticals 7-Apr-09

H2008/18560/583 Dicorate Er 500 Tablets Tablets Divalproex Sodium Equivalent To

Valproic Acid 500mg

Sun Pharmaceuticals 7-Apr-09

H2008/17078/673 Encorate Chrono 500

Tablets

Tablets Sodium Valproate Bp 500mg Sun Pharmaceuticals 7-Apr-09

H2008/19666/602 Epilim 300 Tablets Tablets Sodium Valproate 300mg Sanofi Aventis, France 7-Apr-09

H2008/19667/946 Epilim Intravenous

Injection

Injection Sodium Valproate 400mg Per Vial Sanofi Aventis 7-Apr-09

H2008/19097/853 Gabapentin Capsules

300 Mg

Capsules Gabapentin 300 Mg Universal Corporation Ltd 7-Apr-09

H2008/19903/936 Gabica 100mg

Capsules

Capsules Pregabalin 100mg Getz Pharma Ltd; Pakistan 7-Apr-09

H2009/20476/268 Gabica 150mg

Capsules

Capsules Pregabalin 150mg Getz Pharma Ltd; Pakistan 28-May-09

H2008/19904/937 Gabica 300mg

Capsules

Tablets Pregabalin 300mg Getz Pharma Ltd; Pakistan 7-Apr-09

H2009/20477/269 Gabica 50mg Capsules Capsules Pregabalin 50mg Getz Pharma Ltd; Pakistan 28-May-09

H2009/19902/026 Gabica 75mg Capsules Capsules Pregabalin 75mg Getz Pharma Ltd; Pakistan 7-Apr-09

H2008/18845/792 Labtol-200 Tablets Tablets Carbamazepine Bp 200mg Lab And Allied 7-Apr-09

H2009/18797/710 Lamigin-100 Tablets Tablets Lamotrigine 100mg Intas Pharmaceuticals Ltd 2-Dec-09

H2009/18796/711 Lamigin-50 Tablets Tablets Lamotrigine 50mg Intas Pharmaceuticals Ltd 2-Dec-09

H2008/18932/445 Lamosyn 25 Tablets Tablets Lamotrigine 25mg Sun Pharmaceuticals Ind Survey

No.259/15 Dadra-396 191; India

7-Apr-09

H2008/19504/501 Laxyl 3mg Tablets Tablets Bromazepam Bp 3mg Square Pharmaceuticals Ltd.,


Bangladesh

7-Apr-09

H2008/19493/488 Mexitol Tablets Tablets Flupenthixol Hcl Bp Equivalent

To Flupenthixol 0.5 Mg;

Melitracen Hcl Inn Equivalent To



Bangladesh

7-Apr-09



Registration

Melitracen 10 Mg

H2008/16893/573 Neurotrol Tablets

100mg

Tablets Carbamazepine 100mg Universal Corporation Ltd;

Kenya

7-Apr-09

H2009/20804/564 Nocte Zolpidem 10mg

Tablets

Tablets Zolpidem Tartrate 10mg Laboratorios Bago 1-Sep-09

H2009/20865/529 Novatin 100 Capsules Capsules Gabapentin 100mg Aurobindo Pharma 20-Aug-09

H2009/20866/530 Novatin 300 Capsules Capsules Gabapentin 300mg Aurobindo Pharma 20-Aug-09

H2008/18644/678 Oleanz 10 Mg Tablets Tablets Olanzepine 10 Mg Sun Pharmaceuticals Ind. Ltd.





7-Apr-09

H2008/18817/679 Oleanz 5 Tablets Tablets Olanzapine 5mg Sun Pharmaceuticals Ind. Ltd.





7-Apr-09

H2009/20459/240 Seroplex 10mg Tablets Tablets Escitalopram 10mg Sanofi Aventis 28-May-09

H2009/20371/419 Slipizem – 5mg

Suppositories

Suppositories Diazepam 5 Mg Bliss Gvs Pharma Ltd; India 6-Aug-09

H2009/20370/420 Slipizem 2.5mg

Suppositories

Suppositories Diazepam 2 Mg Bliss Gvs Pharma Ltd; India 6-Aug-09

H2009/19415/506 Valcontin 200 Tablets Tablets Sodium Valproate Bp 133.5mg,

Valproic Acid Usp 58mg (Both

Together Correspond To Sodium

Valproate 200mg In A Controlled

Release System)

Modi-Mundipharma Pvt. Ltd.

India

4-Aug-09

H2009/19417/507 Valcontin 500 Tablets Tablets Sodium Valproate Bp 333mg,

Valproic Acid Usp 145mg (Both

Together Correspond To Sodium

Valproate 500mg In A Controlled

Release System)

Modi-Mundipharma Pvt. Ltd,

India

4-Aug-09

H2009/20656/614 Valtec Cr-500 Tablets Tablets Sodium Valproate Bp 333mg,

Valproic Acid Usp 145mg

Cipla Ltd ; India 8-Sep-09

H2009/20740/630 Valtec-Cr 300mg

Tablets

Tablets Sodium Valproate Bp 200mg,

Valproic Acid Usp 87mg

Cipla Ltd; India 15-Sep-09

H2008/19566/551 Zavesca 10mg Tablets Tablets Escitalopram 10mg Getz Phama Ltd, 29-30/27,

Karachi, Pakistan

7-Apr-09

H2009/20774/415 Zolaram 0.25mg

Tablets

Tablets Alprozolam 0.25mg Aegis Ltd; Cyprus 6-Aug-09

H2009/20773/414 Zolaram 0.5mg Tablets Tablets Alprozolam 0.5mg Aegis Ltd; Cyprus 6-Aug-09

Respiratory Tract Drugs

H2008/18382/387 123 Cold Flu Tablets Tablets Paracetamol 500 Mg;

Pseudoephedrine Hcl 30 Mg;

Chlorpheniramine Maleate 2 Mg

Alkan Pharma 7-Apr-09

H2008/15601/953 Ambrodil Drops (15ml) Oral Drops Ambroxol Hcl Bp 7.5mg Per 5ml Aristo Pharmaceuticals 7-Apr-09

H2008/19491/606 Ambrox 75sr Capsules Capsules Ambroxol Hcl 75mg Square Pharmaceuticals Ltd.,


Bangladesh

7-Apr-09

H2008/19946/824 Ambrox-Denk 60

Tablets

Tablets Ambroxol Hcl 60mg Denk Pharma, Germany 7-Apr-09

H2008/13992/973 Asmadeal Tablets Tablets Ephedrine Hcl 12 Mg,

Theophylline Anhydrous 120 Mg

Biodeal Laboratories Ltd 7-Apr-09

H2008/19772/1035 Asmalin 4 Mg Tablets Tablets Sulbutamol B.P 4 Mg (As

Sulphate)

Universal Corporation Ltd 7-Apr-09

H2007/562 Asmalin Syrup Oral Syrup Salbutamol B.P 2mg Per 5ml Universal Corporation Ltd;

Kenya

17-Jul-07

H2008/19740/878 Becoryl Cough Syrup Syrup Diphenhydramine Hcl Bp

14.08mg, Ammonium Chloride

Bp 138mg, Sodium Citrate Bp

57.03mg, Racementhol Bp

1.14mg Per 5ml

Aglowmed Ltd-India 7-Apr-09

H2008/14131/429 Benacoff Paediatric

Expectorant

Syrup Diphenhydramine Hcl 7mg;

Sodium Citrate 28.5 Mg; Menthol

0.55 Mg Per 5 Ml

Sphinx Pharm. Ltd 7-Apr-09

H2009/20169/92 Benaflu Tablets Tablets Paracetamol Bp 500mg, Caffeine

Bp 30mg, Phenylepherine Hcl

5mg, Chlorpheniramine Maleate

2mg

Benmed Pharmaceuticals Ltd;

Kenya

7-Apr-09

H2008/19382/806 Betasil Medicated

Lozenges

Lozenges Dichlorobenzyl Alcohol

Amylmetacresol Bp 0.6mg

Beta Healthcare Ltd, Industrial

Area Nairobi, Kenya

7-Apr-09

H2008/14934/779 Biocof Compound

Linctus Syrup

Syrup Tincture Squill Bp 0.15ml,

Ammonium Chloride135mg,

Sodium Citrate Bp 57mg,

Biodeal Labs Ltd 7-Apr-09


236


Registration

Ephedrine Hcl Bp 8mg,

Diphenhydramine Hcl Bp 5mg,

Codeine Phosphate Bp 10mg Per

5ml

H2008/14740/780 Biocof Forte

Suspension (100ml)

Oral

Suspension

Tincture Squill Bp 0.15ml,

Ammonium Chloride Bp135mg,


Ephedrine Hcl Bp 8mg,

Diphenhydramine Hcl Bp 5mg Per

5ml

Biodeal Labs Ltd 7-Apr-09

H2009/20233/109 Bisolvon Linctus Da

Sugar Free

Oral Syrup Orciprenaline Sulphate 5mg,

Bromhexine Hcl 4mg Per 5ml

Boehringer Ingelheim 7-Apr-09

H2008/17970/1037 Bromsal Expectorant Syrup Salbutamol Sulphate Bp

Equivalent To Salbutamol 1mg,

Bromhexine Hydrochloride Bp

2mg, Guaifenesin Bp 50mg Per

5ml

Cosmos Ltd 7-Apr-09

H2009/20052/013 Bronchomol Syrup Syrup Salbutamol Sulphate B.P 2mg Per

5ml


H2009/19939/93 Cadex Cough Syrup Oral Syrup Bromhexine Hcl 4mg,

Ammonium Chloride 50mg,

Menthol 2.5mg Per 5ml

Sakar Healthcare-India 7-Apr-09

H2008/12386/597 Chestcof Cough Syrup Syrup Liquorice Liquid Extract Bp 1ml,

Menthol Bp 45mg, Anise Oil Bp

0.05ml, Dementholised Mint Oil

Bp 0.135ml, Ipecacuanha Liquid

Extract Bp 0.075ml, Capsicum

Tincture Bpc 1ml Per 100ml

Elys Chemical Industries Ltd,

Industrial Area Nairobi

7-Apr-09

H2008/10940/598 Chestcof Tablets Tablets Liquorice Liquid Extract 35mg,

Menthol Bp 10mg, Anise Oil Bp

0.001ml, Dementholised Mint Oil

Bp O.Oo1ml, Capsicum Tincture

Bpc 0.02ml, Pumilio Pine Oil Bp

0.001ml, Eucalyptus Oil Bp

0.002ml, Creosote 0.002ml

Elys Chemical Industries Ltd,

Industrial Area Nairobi

7-Apr-09

H2009/20969/743 Ciclohale 80 Inhaler Inhaler Ciclesonide 80 Mcg Per Each

Actuation Delivery

Cipla Ltd 22-OCT-09

H2009/20970/744 Ciclohale 160 Inhaler Inhaler Ciclesonide 160 Mcg Per Each

Actuation Delivery

Cipla Ltd 22-OCT-09

H2009/19240/649 Coldact Capsules Capsules Paracetamol B.P 400mg,

Chlorpheniramine Maleate Bp

4mg, Pseudoephedrine Hcl Bp

30mg, Caffeine Anhydrous Bp

30mg


Kenya

29-Sep-09

H2008/8843/932 Coldamol-P Syrup Syrup Chlorpheniramine Maleate Bp

2mg, Pseudoephrine Hcl Bp

10mg, Paracetamol Bp 120mg Per

5ml


Kenya

7-Apr-09

H2009/18830/533 Cosome Expectorant Syrup Bromhexine Hcl Bp 4.0mg,

Phenylephrine Hcl Bp 5.0mg,

Chlorpheniramine Maleate Bp

2.0mg Per 5ml

Cradel Pharmaceuticals For

Merck India

27-Aug-09

H2009/18877/534 Cosome Syrup Syrup Dextromethrphan Hbr Usp 10mg,

Phenylephrine Hcl Usp 5.0mg,

Chlorpheniramine Maleate Usp

2.0mg Per 5ml

Cradel Pharmaceuticals For

Merck India

27-Aug-09

H2009/18571/621 Dacof Dry Suspension Oral

Suspension

Diphenhydramine Hcl Bp 12.5mg,

Dextromethorphan Hbr 6.5mg,

Menthol Bp 1.10mg Per 5ml

Dawa Ltd 15-Sep-09

H2009/18574/207 Dacof Expectorant Oral Syrup Diphenhydramine Hcl Bp 14mg,

Ammonium Chloride Bp

135.0mg, Sodium Citrate Bp

55mg, Menthol Bp 1.10mg Per 5

Ml

Dawa Ltd 7-Apr-09

H2009/18572/695 Dacof Paediatric Syrup Syrup Diphenhydramine Hcl Bp 7.0mg,

Sodium Citrate Bp 28.5mg,

Menthol Bp 0.55mg

Dawa Ltd 2-Dec-09

H2009/19396/94 Derinide 100 Inhaler Inhaler Budesonide Bp 20mg Per

Canister

Cadila Healthcare Ltd; India 7-Apr-09

H2009/19395/95 Derinide 200 Inhaler Inhaler Budesonide Bp 40mg Per

Canister


H2009/19488/550 Duovent Hfa Inhaler Inhaler Ipratropium Bromide

Monohydrate21μg (Equivalent To

Ipratropium Bromide Anhydrous

20μg) Fenoterol Hbr 50μg Per

Boehringer Ingeilhem 1-Sep-09



Registration

50μl Metered Dose

H2009/19488/497 Duovent Hfa Inhaler Inhaler Ipratropium Bromide

Monohydrate 21mcg (Equivalent

To Ipratropium Bromide

Anhydrous 20mcg) Fenoterol Hbr

50mcg Per 50ml Metered Dose

Boehringer Ingeilhem Pharma.

Gmbh & Co. Kg Ingelheim,

Germany

4-Aug-09

H2009/18707/453 Flemnil Rb Capsules Capsules Bromhexine Hcl Bp 5mg,

Phenylephrine Hcl Bp 5mg,

Guaifenesin Bp 100mg

Raptakos, Bret & Co. 6-Aug-09

H2008/19795/688 Forair 125 Inhaler Inhaler Salmeterol Xinafoate Bp

Equivalent To Salmeterol 25mcg,

Fluticasone Propionate 125mcg

Per Actuation

Cadila Healthcare Ltd 7-Apr-09

H2009/19803/96 Formonide 200 Inhaler Inhaler Budesonide Bp 200mcg;

Formoterol Fumarate 6mcg Per

Actuation


H2009/19796/97 Formonide 400 Inhaler Inhaler Budesonide Bp 400mcg;

Formoterol Fumarate 6mcg Per

Actuation


H2008/19253/620 Indirab Vaccine Injection Purified Bpl Inactivated Rabies

Virus ≥ 2.5 I.U. Per Dose

Bharat Biotech

Internationalnltd; Genome

Valley, Shameerpet, Hyderabad

500078 A. P. India

7-Apr-09

H2008/19842/714 Instaryl Expectorant Syrup Salbutamol Sulphate Bp

Equivalent To Salbutamol 4mg,

Bromhexine Hcl Bp 8mg,

Phenylephrine Hcl Bp 5mg Per

10ml



7-Apr-09

H2008/20083/943 Instaryl-D Syrup Syrup Chlorpheniramine Maleate Bp

2mg, Dextromethorphan

Hydrobromide Bp10mg,

Guaifenesin Bp 50mg,

Ammonium Chloride Bp 75mg

Per 5ml

Aglowmed Ltd; 190, Dabhel,

Nani Daman, 396210, India

7-Apr-09

H2008/20096/951 Kofarest Syrup Syrup Salbutamol Sulphate Bp 2mg,

Ambroxol Hcl Bp 30mg,

Guaifenesin Bp 100mg, Menthol

Bp 5mg Per 5ml

Centaur Pharmaceuticals Ltd,

India

7-Apr-09

H2008/19019/644 Lastmol Injection Injection Salbutamol Base 0.5mg As

Sulphate Bp Per Ml

Lab & Allied Ltd; Kenya 7-Apr-09

H2008/19269/621 Levolin 1.25 Mg

Respules

Solution For

Inhalation

Levosalbutamol Sulphate

Equivalent To Levosalbutamol

1.25 Mg Per 2.5ml

Cipla Ltd; Plot # L-139, Verna,

Goa 403 722, India

7-Apr-09

H2008/19160/519 Levostar Syrup Syrup Levosalbutamol Inn 1mg Per 5ml Square Pharmaceuticals Ltd.,


Bangladesh

7-Apr-09

H2008/19708/633 Mediform Plus-200 Hfa

Inhaler

Inhaler Formoterol Fumarate Ph Eur

6mcg, Budesonide Bp 200mcg Per

Metered Dose

Meditab Specialities Pvt Ltd, L-

139 Verna Goa, India

7-Apr-09

H2009/19281/034 Mestil-S Syrup Syrup Ambroxol Hcl 15mg, R-

Salbutamol 1mg, Guaifenesin Bp

50mg, Menthol 1mg Per 5ml

Universal Pharmaceuticals Ltd,

(India), Pipdic Industrial Estate,

India

7-Apr-09

H2008/19501/502 Mucospel Syrup Syrup Bromhexine Hcl Bp 4mg Per 5ml Square Pharmaceuticals Ltd.,


Bangladesh

7-Apr-09

H2009/20255/717 Nexahist Syrup Syrup Promethazine Hcl Bp 2.5mg,

Diphenhydramine Hcl Bp 5mg,

Ammonium Chloride Bp 90mg,


Ephedrine Hcl Bp 7.5mg

Naxpar For Sonal Holdings 2-Dec-09

H2008/18545/940 Nokof Syrup Syrup Carbocisteine Bp 125mg Per 5ml Beximco 7-Apr-09

H2009/19938/205 Onacof Syrup Oral Syrup Salbutamol 1mg, Bromhexine Hcl

2mg, Guaiphenesin 50mg,

Menthol 0.5mg Per 5ml

Sakar Healthcare-India 7-Apr-09

H2009/20724/436 Osscoff Syrup Oral Syrup Diphenhydramine 12.5mg,

Ammonium Chloride 12.5 Per 5ml

Osschemie Ltd; Kenya 6-Aug-09

H2008/19104/817 Ossthiol Expectorant

5% Syrup

Syrup Carbocistein 5gm Per 100ml Oss-Chemie (K) Ltd 7-Apr-09

H2008/19102/818 Ossthiol Promethazine

Syrup

Syrup Carbocisteine 2gm, Promethazine

Hcl 0.05gm Per 100ml


H2008/19013/819 Osthiol Carbocistein

2% Syrup

Syrup Carbocistein 2gm Per 100ml Oss-Chemie (K) Ltd 7-Apr-09

H2009/20244/568 Pectadyl Expectorant

Syrup

Syrup Diphenhydramine Hcl Bp 10mg,


Sodium Citrate Bp 35mg, Menthol

Elys Chemicals Ltd; Kenya 1-Sep-09


238


Registration

Bp 1mg Per 5ml

H2009/20338/609 Pulmin Inhaler Inhaler Salbutamol 0.2mg Kopran Ltd-Manufacturer

Midas Care Ltd; India

8-Sep-09

H2009/20285/313 Revac-B Mcf Injection Injection Purified Hepatitis B Surface

Antigen (>98% Purity) 10mcg

Bharat Biotech International Ltd 6-Aug-09

H2008/19404/796 Rynadil 2% Syrup Syrup Carbocisteine Bp 100mg Per 5ml Coral Laboratories Ltd 7-Apr-09

H2008/19403/797 Rynadil 5% Syrup Syrup Carbocisteine Bp 250mg Per 5ml Coral Laboratories Ltd 7-Apr-09

H2008/19405/798 Rynadil Promethazine

Syrup

Syrup Carbocisteine Bp 100mg,

Promethazine Hcl Bp 2.5mg Per

5ml

Coral Laboratories Ltd 7-Apr-09

H2009/20565/347 Salburon 4mg Tablets Tablets Salbutamol 4mg Metro Pharmaceuticals Ltd 7-Apr-09

H2008/16600/767 Saphyllin Syrup 100ml Syrup Ambroxol Hydrochloride 15mg,

Salbutamol Sulphate Ip Equivalent

To Salbutamol 1mg Per 5ml


H2008/19678/967 Seroflo 250mg Inhaler Inhaler Salmeterol Xinafoate Equivalent

To Salmeterol Ph. Eur. 25mg,

Fluticasone Propionate Bp

250mcg Per Actuation


H2008/17616/799 Seroflo-500 Multihaler Inhaler Salmeterol (As Xinafoate) 50mcg,

Fluticasone Propionate Bp

500mcg Per Actuation


H2008/19272/535 Simply One 160

Inhaler

Inhaler Ciclesonide 160 Mcg; Formoterol

Fumarate 2h2o Ph. Eur. 4.5 Mcg

Per Actuation


H2008/19271/893 Simply One 80 Inhaler Inhaler Ciclesonide 80 Mcg, Formoterol

Fumarate 2h2o Ph. Eur 4.5 Mcg

Per Actuation

Cipla Ltd; Plot # L-139, Verna,

Goa 403 722, India

7-Apr-09

H2009/19942/112 Sinumax Allergy Sinus

Caplets

Tablets Paracetamol 500mg,

Pseudoephedrine Hcl 30mg,

Chlorpheniramine Maleate 2mg


H2009/19943/214 Sinumax Caplets Tablets Paracetamol 500mg,

Pseudoephedrine Hcl 30mg

Janssen-Cilag 28-May-09

H2009/19944/611 Sinumax Cold And Flu

Caplets

Tablets Ibuprofen 200mg,

Pseudoephedrine Hcl30mg

Janssen-Cilag 8-Sep-09

H2009/19941/206 Sinumax With Codeine

Caplets

Tablets Paracetamol 500mg,

Pseudoephedrine Hcl 30mg,

Codeine Phosphate 8mg


H2008/19226/479 Sonacof Tablets Tablets Menthol 10mg; Camphor 0.15mg;

Thymol 0.2mg; Eucalyptus Oil

2mg

Sonal Holdings(K) Ltd

Manufactured By Naxpar; India

7-Apr-09

H2009/20256/140 Sonacold With Vitamin

C Caplets

Tablets Paracetamol Bp 500mg,

Phenyepherine Hcl Bp 5mg,

Caffeine Bp 25mg, Terpin

Hydrate Usp 20mg, Vitamin C

30mg

Naxpar For Sonal Holdings (K)

Ltd

7-Apr-09

H2009/20647/352 Strepsil Cool Lozenges Lozenges Dichlorobenzyl Alcohol 1.2mg,

Amylmetacresol Bp 600mcg

Reckit Benkiser 6-Aug-09

H2009/20648/353 Strepsil Orange Vit C

Lozenges

Lozenges Dichlorobenzyl Alcohol 1.2mg,

Amylmetacresol Bp 600mcg,

Vitamin C 100mg

Reckit Benkiser 6-Aug-09

H2008/13562/1029 Trizine-D Tablets Tablets Cetirizine Hcl Bp 5mg,

Pseudoephedrine Hcl Bp 120mg

Cipla 7-Apr-09

H2008/15928/710 Tussex Syrup Syrup Dextromethorphan Hydrobromide

Bp 10mg, Guaiphenesin Bp

100mg, Paracetamol Bp 250mg,

Menthol Usp 1.5mg Per 5 Ml

Medriech Sterilab Ltd 7-Apr-09

H2009/18923/121 Unicontin 400 Tablets Tablets Theophylline Bp 400mg Modi-Mundipharma Pvt Ltd 7-Apr-09

H2008/19137/1055 Unicontin 600 Mg

Tablets

Tablets Theophylline Bp 600 Mg Modi-Mundipharma Pvt. Ltd;

India

7-Apr-09

H2009/20314/163 Upacof Dry Cough

Syrup

Oral Syrup Dextromethorphan Hbr Bp 15mg

Per 5ml


Kenya

7-Apr-09

H2009/20312/164 Upacof Expectorant Oral Syrup Diphenhydramine Hcl Bp 12.5mg,


Sodium Citrate Bp 50mg Per 5ml


Kenya

7-Apr-09

H2009/20313/165 Upacof Paediatric

Syrup

Oral Syrup Diphenhydramine Hcl Bp 6.25mg,


Sodium Citrate Bp 25mg Per 5ml


Kenya

7-Apr-09

H2008/20030/995 Ventil Tablets Tablets Salbutamol Sulphate Bp 4mg Biodeal Laboratories 7-Apr-09

H2008/14723/594 Vifex Syrup (100ml) Syrup Salbutamol (Sulphate) Bp1mg,

Bromhexine Hcl Bp 2mg,

Guaifenesin Bp 50mg Per 5ml

Emcure Pharmaceuticals 7-Apr-09

H2009/19900/108 Zyntus-D Cough Syrup Oral Syrup Dextromethorphan Hydrobromide

Bp 5mg, Bromhexine Hcl Bp

4mg, Chlorpheniramine Maleate

Sakar Heathcare, India 7-Apr-09



Registration

Bp 2mg Per 5ml

Solutions For Water, Electrolyte, Acid-Base Disturbance

H2008/19359/443 Dipeptiven Infusion Injection N-L-Alanyl-L-Glutamine 200gm

Per 1000ml

Fresenius Kabi Deutschland

Gmbh, D-61346 Homburg;

Germany

7-Apr-09

H2008/19278/433 Haes-Steril 6%

Infusion

Injection Poly(O-2-Hydroxyethyl) Starch

60.00 Gm; Sodium Chloride 9.00

Gm

Infusion Kenya Ltd 7-Apr-09

H2009/19989/130 Livamin Infusion Injection L-Isoleucine 3.80g, L-Leucine

4.25g, L-Lysine Monomalate

3.93g, L-Methionine 0.25g, L-

Phenylalanine 0.25g, L-Threonine

0.60g, L-Tryptophan 0.05g, L-

Valine 3.20g, L-Arginine 2.45g,

L-Histidine 0.30g, L-Ornithine-L-

Aspartate 4.015g, L-Alanine

1.05g, N- Acet


H2008/19594/814 Mannitol Iv Infusion Injection Mannitol Bp 20.0gm Per 100ml Marck Biosciences Ltd 7-Apr-09

H2009/19990/133 Precopar Infusion Injection L-Isoleucine 4.225g, L-Leucine

4.73g, L-Valine 3.545g, L-

Arginine 7.5g, L-Ornithine-L-

Aspartate 5.00g, L-Malic Acid

3.50g, Xylitol 25.0g, Pyridoxine

Hydrochloride 0.06g,

Nicotinamide 0.04g, Sodium

Acetate 0.915g, Sodium Chloride

0.993g, Magnesium Sulfate


H2008/19940/827 Sterile Water For

Injection

Injection Sterile Water For Injection 5ml Medreich-India 7-Apr-09

Vitamin & Minerals

H2008/19280/960 Magnesium Sulfate 50

%W/V Injection

Injection Magnesium Sulfate Heptahydrate

500 Mg Per 5 Ml

Pharmaceutical Solutions

Industry Ltd, P.O. 17476,

Jeddah, 21484, Kingdom Of

Saudi Arabia

7-Apr-09

H2008/18115/903 Magnesium Sulphate

50% Injection

Injection Magnesium Sulphate

Heptahydrate Bp 50%W/V

Equivalent To Magnesium Ions

2.03mmol Per Ml

Lab & Allied; Kenya 7-Apr-09

H2008/18353/897 Uroxia Liquid Oral Liquid L-Leucine Usp 18.3mg, L-

Isoleucine Usp 5.9mg, L-Lysine

Hcl Usp 25mg, L-Phenylalanine

Usp 5mg, L-Threonine Usp

4.2mg, L-Methionine Usp 9.2mg,

L-Tryptophan Usp 5mg, L-Valine

Usp 6.7mg, Thiamine Hcl Bp

5mg, Riboflavin Bp 3mg,

Pyridoxine Hcl 1.5mg, Nicotina

Coral 7-Apr-09

H2009/20100/231 Slow Kal-K Tablets Tablets Potassium Chloride Bp 600mg Ambalal Sarabhai , India 28-May-09

H2008/19360/440 Additrace Infusion Injection Iron 2.0 Micromol; Zinc 10.0

Micromol; Manganese 0.5

Micromol; Copper 2.0 Micromol;

Chromium 0.02 Micromol;

Selenium 0.04 Micromol;

Molybdenum 0.5 Micromol;

Floride 5.0 Micromol; Iodide 0.1

Micromol Per 10 Ml



Germany

7-Apr-09

H2008/19749/1032 Amifer Iron Syrup Syrup Ferric Ammonium Citrate

172.41mg, Folic Acid 2.5mg,

Vitamin B12 0.02mg Per 5ml

Dafra Pharma Ltd, Kenya 7-Apr-09

H2008/19340/383 Apcal Forte Tablets Tablets Calcium Citrate Usp Equivalent

To Elemental Calcium 250 Mg

Ajanta Pharma Ltd; B-4/5/6;

Midc Area, Paithan 431 128,

India

7-Apr-09

H2009/19766/673 Apcal Syrup Syrup Calcium 150mg, Magnesium

25mg, Zinc 4mg, Cholecalciferol

Bp 200iu

Ajanta Pharma Ltd 2-Dec-09

H2009/19844/712 Appeton A To Z Kids

Vitamin C Strawberry

Flavour Tablets

Tablets Vitamin C 19.8mg, Sodium

Ascorbate 14.55mg

Kotra Pharma - Malaysia 2-Dec-09

H2009/19844/645 Appeton A To Z Kids

Vitamin C Tablets

Tablets Vitamin C 30mg Kotra Pharma; Malaysia 29-Sep-09

H2009/19819/484 Appeton Activ-C

Blackcurrant Tablets

Tablets Vitamin C 40mg, Sodium

Ascorbate 67.5mg


H2009/19820/485 Appeton Activ-C

Orange Tablets

Tablets Vitamin C 60mg, Sodium

Ascorbate 67.5mg


H2008/15095/735 Appevite Forte Syrup Syrup Cyproheptadine Hcl 2mg, Sphinx Pharmaceuticals; Kenya 7-Apr-09


240


Registration

Carnitine Chlorhydrate 150mg,

Lysine Chlorhydrate 150mg,

Vitamin B1 10mg, Vitamin B6

10mg, Vitamin B12 100mcg Per

5ml

H2008/12231/462 Astymin-Sn Injection Injection Isoleucine 5.6mg; Leucine

12.5mg; Lysine 11mg; Methionine

3.5mg; Phenylalanine 9.35mg;

Threonine 6.5mg; Tryptophan

1.3mg; Valine 4.5mg; Alanine

6.2mg; Arginine 6.2mg; Aspartic

Acid 3.8mg; Cystine 1.45mg;

Glutamic Acid 6.5mg; Histidine

8.11mg; Proline 3.3m

Tablets (India) Ltd; India 7-Apr-09

H2008/18980/609 Bebevit Oral Drops Oral Drops Vitamin A 1500 I.U, Vitamin D3

400 I.U, Vitamin E 5.0mg,

Vitamin B1 0.5mg, Vitamin B2

0.6mg, Vitamin B6 0.6mg,

Nicotinamine 8.0mg, Vitamin C

40.0mg Per Ml

Medical Union Pharamceuticals,

Abu-Sultan, Ismailia, Egypt.

7-Apr-09

H2009/19720/686 Betavit Plus Capsules Capsules Calcium, 75.0mg, Magnesium

Sulphate Equivalent To

Magnesium 3.0mg, Phosphorus

58.0mg, Zinc Oxide Equivalent

To Zinc 10.0mg, Selenious Acid

Equivalent To Selenium 100mcg,

Copper Sulphate Equivalent To

Copper 0.25mg, Manganese

Sulphate Equivalent To Mangane

Cipla Ltd 2-Dec-09

H2008/19500/695 Bicozin Syrup Syrup Thiamine Hcl Bp 5mg, Riboflavin

(As Riboflavin-5-Phosphate

Sodium Bp) 2mg, Pyridoxine Hcl

Bp 20mg, Nicotinamide Bp 20mg,

Zinc 10mg Per 5 Ml

Square Pharmaceuticals 7-Apr-09

H2009/18928/344 Bioferon Capsules Capsules Ferrous Fumerate 305mg

Equivalent To Elemental Iron

100mg, Folic Acid 0.75mg,

Cyanocobalamin 5mcg, Ascorbic

Acid 75mg, Zinc Sulphate 5mg

Medreich Ltd; India 6-Aug-09

H2008/19739/648 Bnc Syrup Syrup Vitamin B1 2.5mg, Vitamin B2

2.5mg, Vitamin B6 1.5mg,

Nicotinamide Bp 25mg,

Dexpanthenol Bp 2.5mg, Vitamin

C Bp 37.5mg Per 5ml

Aglowmed Ltd India 7-Apr-09

H2009/20178/440 Cachnerve Capsules Capsules Alpha Lipoic Acid Usp100mg,

Gamma Linolenic Acid 60mg,

Pyridoxine Hcl Bp 3mg,

Methylcobalamin 1.5mg,

Chromium Picolinate Usp

Equivalent To Chromium 50mcg


India

6-Aug-09

H2008/19947/825 Calci D-Denk Tablets Tablets Calcium Carbonate 2500mg

Equivalent To Calcium 1000mg,

Cholecalciferol 22mcg Equivalent

To 880 Iu Vitamin D3

Denk Pharma, Germany 7-Apr-09

H2008/18837/978 Calcium Gluconate

Injection

Injection Calcium Gluconate 1gm Per

Ampoule

Caplin Point Labs 7-Apr-09

H2008/18358/610 Calcium Sandoz Junior

Tablets

Tablets Calcium Carbonate Ip 625mg Atra Pharmaceutucals Pvt. Ltd.,

H-19, Midc, Waluj,

Aurangabad-431133, India For

Novartis Healthcare Pvt. Ltd.

7-Apr-09

H2008/13249/781 Cal-Mag Tablets Tablets Calcium Glycinate Equivalent To

Calcium 300mg, Magnesium

Glycinate Equivalent To

Magnesium150mg




Usa

7-Apr-09

H2009/20660/374 Calter Plus Suspension Oral

Suspension

Calcium Carbonate Bp 150mg,

Magnesium Hydroxide 25mg,

Zinc Gluconate Usp 2mg, Vitamin

D3 Bp 200iu

Zest 6-Aug-09

H2009/20291/218 Calter Plus Tablets Tablets Calcium Carbonate Bp 1000mg

Equivalent To Elemental Calcium

400mg, Magnesium Hydroxide Bp

240mg Equivalent To Elemental

Magnesium 100mg, Zinc Sulphate

Monohydrate Usp 11mg

Equivalent To Elemental Zinc

Zest Pharma Ltd; India 28-May-09



Registration

4mg, Vitamin D3 Bp 200iu

H2008/13250/783 Chelated Zinc Tablets Tablets Zinc Methionate Equivalent To

Zinc 30mg




Usa

7-Apr-09

H2009/18984/699 Dawavite Syrup Syrup Vitamin A Bp 1500 I.U, Vitamin

D3 Bp 25 I.U, Thiamine Hcl

(Vitamin B1) Bp 0.5mg,

Riboflavine (Vitamin B2) Bp

0.5mg

Dawa Ltd 2-Dec-09

H2009/20156/203 Dexorange Capsules Tablets Ferric Ammonium Citrate Bp

160mg, Cyanocobalamin Bp

7.5mcg, Folic Acid Bp 0.5mg,

Zinc Sulphate Monohydrate Usp

20.61mg

Franco-Indian Pharmaceuticals 7-Apr-09

H2008/19561/957 Fecontin-Z Tablets Tablets Ferrous Glycine Sulfate

Equivalent To Ferrous Iron

100mg, Zinc Sulfate Monohydrate

Usp 61.8mg, Folic Acid Bp 0.5mg

Modi-Mundipharma Pvt. Ltd.

At Modipuram-250 110, Up.,

India

7-Apr-09

H2008/18354/882 Ferizest Suspension Oral

Suspension

Elemental Iron 50mg, Folic Acid

Bp 500mcg, Cyanocobalamin Bp

6mcg, Elemental Zinc 11mg Per

5ml

Coral 7-Apr-09

H2008/15518/749 Feton Syrup Syrup Folic Acid Bp 0.5mg, Iron- (111)-

Hydroxide Polymaltose Complex

30% Equivalent To Elemental

Iron 50mg Per 5ml


H2008/15517/750 Feton Tablets Tablets Folic Acid Bp 1mg, Iron- (111)-

Hydroxide Polymaltose Complex

30% Equivalent To Elemental

Iron 100mg


H2008/17370/469 Fortaline Gels Capsules Epa/Dha 500mg; Dl Alpha

Tocopherol Acetate 10mg

Mpf Bv Applehof Netherlands 7-Apr-09

H2008/13251/789 Gnld Vitasquares

Tablets

Tablets Vitamin A 3000 I.U, Vitamin D

400 I.U, Vitamin E 10 Mg,

Vitamin C 60mg, Vitamin

B11.5mg, Vitamin B2 1.5mg,

Vitamin B6 1.4mg, Vitamin B12

3.0mcg, Nicotinamide 1.3mg,

Folic Acid 200mcg, Biotin

150mcg, Pantothenic Acid 10mg,

Iron 6mg, Iodine 75mcg, Zinc

7.5m




Usa

7-Apr-09

H2009/19800/221 Ideos Chewable Tablets Tablets Calcium Carbonate 1.25g

Corresponding To Elemental

Calcium 500mg, Vitamin D3 400

Iu

Innotech International 28-May-09

H2008/19098/540 Maxivit Capsules Capsules Vitamin A Palmitate Usp 5000iu;

Vitamin D3 Usp 400iu; Vitamin

B1 (Mono Nitrate) Bp 4.5mg;

Vitamin B2 Bp 5mg; Vitamin B6

Bp 1.5mg; Vitamin B12 Bp 5mcg;

Calcium D-Pantothenate Bp 5mg;

Vitamin C Bp 75mg; Niacinamide

Bp 45mg; Dibasic Calcium

Phosphate Usp 96.

Agio Pharmaceuticals Ltd., 86-

A, L.B.S. Marg, Mulund(W),

Mumbai-400 080, India

7-Apr-09

H2008/19571/645 M-Calz Suspension Oral

Suspension

Calcium Citrate Usp Equivalent

To Elemental Calcium 100mg,

Colecalciferol Bp 200iu Per 5ml





Tamilnadu, India

7-Apr-09

H2009/20431/641 M-Calz Tablets Tablets Calcium Citrate Usp 1000mcg,

Magnesium Hydroxide Bp100mg,

Zinc Sulphate Monohydrate Usp

4mg, Colecalciferol Bp 200iu

Stedman Pharmaceuticals Ltd 22-Sep-09

H2009/20563/345 Multiace Tablets Tablets Vitamin A Bp 2500iu, Vitamin B1

Bp 2mg, Vitamin B2, Bp 3mg,

Vitamin B3 Bp 26mg, Vitamin C

Bp 50mg, Vitamin D3 Bp 300iu

Metro Pharmaceuticals Ltd 7-Apr-09

H2008/18630/562 Nervijen Capsules Capsules Methlycobalamine 700 Mcg;

Alpha Lipoic Acid Usp 100 Mg;

Thiamine Mononitrate Bp 5 Mg;

Riboflavine Bp 5 Mg; Pyridoxine

Hydrochloride Bp 1.5 Mg;

Nicotinamide Bp 50 Mg; Calcium

Jenburkt Pharmaceuticals Ltd;

India

7-Apr-09


242


Registration

Pantothenate Bp 25 Mg; Folic

Acid Bp 0.75 Mg Per Soft Gelatin

Capsule

H2008/19492/622 Neuro-B Tablets Tablets Thiamine Mononitrate (Vit. B1)

Bp 100mg, Pyridoxine Hcl (Vit.

B6) Bp 200mg, Cyanocobalamin

(Vit. B12 Bp 200mcg



Bangladesh

7-Apr-09

H2009/20670/720 Neurobest Injection Injection Thiamine Hydrochloride Bp

100mg, Pyridoxine Hydrochloride

Bp 100mg, Cyanocobalamine Bp

1mg

Renata Ltd 2-Dec-09

H2009/20735/687 Neurobest Tablets Tablets Thiamine Mononitrate Bp 100mg,

Pyridoxine Hydrochloride Bp

200mg, Cyanocobalamine Bp

200mcg

Renata 29-Sep-09

H2008/19455/861 Nutrifer Junior Syrup Syrup Ferrous Fumarate Bp 100mg,

Cyanocobalamin Bp 5mcg, Folic

Acid Bp 0.5mg Per 5ml

Ajanta Pharma Ltd 7-Apr-09

H2009/19059/177 Ocin Injection Injection Synthetic Oxytocin Bp 5iu Per

Ampoule

Opsonin 7-Apr-09

H2009/20604/691 Osteocal Suspension Suspension Milk Calcium 600mg Equivalent

To Elemental Calcium 150mg,

Elemental Phosphorus 75mg,

Colecalciferol Bp 200 I.U

Dwd Pharmaceuticals Ltd 2-Dec-09

H2008/18693/623 Osteocal Tablets Tablets Milk Calcium 1200 Mg

Equivalent To Elemental Calcium

300 Mg, Elemental Phosphorous

150 Mg, Vitamin D3 Bp 100 I.U.

Dwd Pharmaceuticals Ltd 7-Apr-09

H2009/20526/625 Ostocal D Tablets Tablets Calcium 500mg, Vitamin D 200iu Eskayef; Bangladesh 15-Sep-09

H2008/19361/449 Peditrace Solution For

Injection

Injection Zinc 3.82 Micromol (250 Mg);

Copper 20.0 Mg; Manganese 1.0

Mg; Selenium 2.0 Mg; Floride

57.0 Mg; Iodide 1.0 Mg



Germany

7-Apr-09

H2009/20182/076 Polybenvite Syrup Oral Syrup Vitamin A Bp 1000iu, Vitamin B1

Bp 0.5mg, Vitamin B2 Bp 0.5mg,

Vitamin B6 Bp 0.5mg, Vitamin C

Bp 20mg, Vitamin D3 Bp 200iu,

Nicotinamide Bp 5mg Per 5ml

Benmed Pharmaceuticals Ltd;

Kenya

7-Apr-09

H2009/20448/501 Pregnavit Fortified

With Omega 3 Tablets

Tablets Carbonyl Iron Equivalent To

Elemental Iron 120mg, Vitamin C

100mg, Vitamin B6 20mg,

Vitamin E 10iu, Vitamin B1 3mg,

Vitamin B2 3mg, Vitamin A

2700iu, Vitamin D3 400iu,

Vitamin B12 12mcg, Docusate

Sodium 50mg, Omega 3 Lipid

Concentrate 20mg, Niacinamide

20

Shapaco Pharmaceutical Ind;

Yemen

4-Aug-09

H2009/17429/215 Purecal Suspension Oral

Suspension

Calcium 160 Mg, Phosphorus 69

Mg, Vitamin D3 Bp 200 Iu Per 5

Ml

Sai Mirra Innopharm Pvt. Ltd;

India Forprisma

Pharmaceuticals Ltd; United

Kingdom

28-May-09

H2008/18868/496 Redin Plus Capsules Capsules Elemental Iron (As Carbonyl Iron)

100mg; Folic Acid Bp 5mg; Zinc

Sulphate Monohydrate Usp 30mg;

Selenium (As Sodium Selenite)

50mcg; Histidine Hcl

Monohydrate Bp 4mg; Lysine Hcl

Usp 25mg; Choline Bitartrtate

Usp 50mg

Fourrts (India) Lab Pvt. Ltd 7-Apr-09

H2008/18869/378 Redin Pn Solution Oral Solution Ferric Ammonium Citrate 230

Mg; Calcium Lactate Pentahydrate

Bp 50 Mg; Protein Hydrolysate

(Equivalent To 75% Of Protein)

100 Mg; Cyanocobalamin Bp 2.5

Mcg; Folic Acid Bp 0.5 Mg; Zinc

Sulphate Heptahydrate Bp 35 Mg;

Selenium (As Sodium Selenite) 25

Mcg; M

Fourrts (India) Lab Pvt. Ltd,

Vandalur Road, Kelambakkam

– 603 103, Tamil Nadu, India

7-Apr-09

H2009/18900/360 Salmoncal Injection Injection Synthetic Salmon Calcitonin B.P.

100 I.U

Shreya Life Sciences Pvt 6-Aug-09

H2009/20019/392 Seven Seas Capsules Capsules Pure Cod Liver Oil 525mg,

Omega-3 120mg, Vitamin A

800mcg, Vitamin D 2.5mcg,

Vitamin E 0.33mcg

Seven Seas Healthcare, Uk 6-Aug-09



Registration

H2008/19373/417 Sterilised Water For

Injection

Injection Water For Injection 10ml Marck 7-Apr-09

H2009/19801/578 Tot Hema Oral

Solution

Oral Solution Iron Gluconate Equivalent To Iron

50mg, Manganese Gluconate

Equivalent To Manganese

1.33mg, Copper Gluconate

Equivalent To Copper 0.70mg

Laboratoire Innotech 1-Sep-09

H2009/19823/713 Vitalic Capsules Capsules Vitamin B1 100mg, Vitamin B6

200mg, Vitamin B12 200mg

Kotra Pharma - Malaysia 2-Dec-09

H2008/19722/728 Zifer-Tr Capsules Capsules Ferrous Sulphate Usp 150mg,

Zinc Sulfate Monohydrate Usp

61.8mg, Folic Acid Usp 0.5mg

Navana Pharmaceuticals Ltd,

3/C, Purana Paltan, Dhaka,

Bangladesh

7-Apr-09

H2009/20545/584 Zincofer Liquid Oral Solution Ferric Ammonium Citrate Usp

225mg, Cyanocobalamin Bp

7.5mg, Pyridoxine Hcl Bp 1.5mg,

Nicotinamide Bp 50mg, Zinc

Sulphate 22.2mg Per Ml

Apex Laboratories 1-Sep-09

H2009/20543/585 Zincovit Drops Oral Solution Vitamin A Bp 2500iu, Vitamin D3

Bp 200iu, Vitamin E Bp 2.5iu,

Thiamine Nitrate Bp 1mg,

Riboflavine Bp 1mg, Pyridoxine

Hcl Bp 0.5mg, Calcium

Pantothenate Bp 1mg,

Nicotinamide Bp 10mg, Ascorbic

Acid 40mg, Lysine Hcl 10mg,

Zinc Sulphate 22.2mg


H2009/20542/586 Zincovit Syrup Syrup Vitamin A Bp 800iu, Vitamin D3

Bp 100iu, Vitamin E Bp 2.5iu,

Thiamine Nitrate Bp 0.75mg,

Riboflavine Bp 0.75mg,

Pyridoxine Hcl Bp 0.5mg,

Cyanocobalamin Bp 0.5mg,

Calcium Pantothenate Bp 0.5mg,

Nicotinamide Bp 7.5mg, Lysine

Hcl 5mg, Copper Sulphate Bp 100


H2009/20541/587 Zincovit Tablets Tablets Vitamin A Bp 500iu, Vitamin D3

Bp 400iu, Vitamin E Bp 15iu,

Thiamine Nitrate Bp 10mg,

Riboflavine Bp10mg, Pyridoxine

Hcl Bp 2mg, Cyanocobalamin Bp

7.5mg, Calcium Pantothenate Bp

10mg, Ascorbic Acid Bp 75mg,

Magnesium Oxide Bp 30mg,

Manganese Sulphate Bp


H2009/19987/167 Benutrion Ve Infusion Injection L- Isoleucine 0.628g, L- Leucine

0.698g, L- Lysine 0.523g, L-

Methionine 0.244g Per 250ml

Pt Sanbe Farma, Indonesia 7-Apr-09

H2009/20412/472 Famusun 10% Injection Injection Soybean Oil 10gm, Glycerol

2.2gm, Egg Lecithin 1.2gm Per

100ml

Sichuan Kelun Pharmaceutical

Co.Ltd; China

23-Jun-09

H2009/20413/473 Famusun 20% Injection Injection Soybean Oil 20gm, Glycerol

2.2gm, Egg Lecithin 1.2gm Per

100ml

Sichuan Kelun Pharmaceutical

Co.Ltd; China

23-Jun-09

Miscellaneous

H2008/18405/461 Anaeban Capsules Capsules Bacillus Subtilis Pb6 Complex Kemin Pharma Bvba(Bg) 7-Apr-09

H2009/18556/075 Anomex Anal

Suppositories

Suppositories Hydrocortisone Acetate Bp

0.25%, Lidocaineusp 3%, Zinc

Oxide Usp 5%, Allantoin Bp 0.5%

Per Suppository

Bliss Gvs Pharma Ltd; India 7-Apr-09

H2009/20202/086 Aquarest 250mg Oral

Powder

Oral Powder Saccharomyces Boulardii

(Lyophilized) 282.5mg Equivalent

To Yeast 250mg Per Sachet

Sai Mirra Imnopharm Pvt Ltd;

India

7-Apr-09

H2009/18852/194 Bonefos 800 Mg

Tablets

Tablets Disodium Clodronate 4h2o


Disodium Clodronate 800 Mg

Bayer Schering 7-Apr-09

H2008/18895/696 Bongard 70 Mg Tablets Tablets Alendronate Sodium 3 H2o

Equivalent To Alendronic Acid

Usp 70 Mg


H2009/20823/458 Cinoplus Suppositories Suppositories Cinchocain Hcl Bp 5mg,

Hydrocortisone 5mg, Framycetin

Sulphate Bp 10mg, Aesculin Inn

10mg

Acme Laboratories Ltd;

Bangladesh

6-Aug-09

H2009/19185/515 Diariv Suspension Oral

Suspension

Di-Iodo Hydroxyquinoline

150mg, Phthalyl Sulphathiazole

1mg, Homatropine Methyl

Riva Pharma S.A.E 18-Aug-09


244


Registration

Bromide 100mg, Stretomycin

Sulphate 100mg Per 5ml

H2008/19665/601 Enterogermina

Suspension

Oral

Suspension

Spores Of Polyantibiotic Resistant

Bacillus Clausii 2 Billion Per Vial

Sanofi Aventis 7-Apr-09

H2009/19873/597 Foseal 400 Tablets Tablets Sevelamer Hydrochloride 420mg

Equivalent To Sevelamer 400mg

Emcure Pharmaceuticals Ltd,

India

8-Sep-09

H2009/19872/598 Foseal 800 Tablets Tablets Sevelamer Hydrochloride 840mg

Equivalent To Sevelamer 800mg

Emcure Pharmaceuticals Ltd,

India

8-Sep-09

H2009/19486/553 Gemfos 35mg Tablets Tablets Risedronate Sodium 35mg (As

Risedronate Hemi-Pentahydrate)

Alkem Laboratories Ltd. 1-Sep-09

H2008/19217/883 Glizigen Spray 60ml Spray Glycyrrhizic Acid 1.9% Catalysis, Macarena, 14 28016,

Spain

7-Apr-09

H2008/19895/775 G-R Six Capsules Capsules Bioflavonoids 100mg, Royal Jelly

90mg, Ginseng Extract 40mg,

Wheat Germ Oil 200mg,

Safflower Oil 300mg, Yeast

Concentrate 200mg

Medical Union Pharmaceuticals,

Egypt

7-Apr-09

H2009/20467/599 Gripe Water Oral Solution Sodium Bicarbonate Bp 50mg;

Terpeneless Dillseed Oil Bp

2.1mg

Dawa Ltd; Kenya 8-Sep-09

H2009/20043/129 Gyno Kit Tablets Tablets Secnidazole 1gm, Azithromycin

1gm, Fluconazole Usp 150mg Per

Kit

Plethico Pharmaceuticals 7-Apr-09

H2008/19736/884 Hyorth Injection Injection Sodium Hyaluronate Bp 10mg Per

Ml

Virchow 7-Apr-09

H2009/20581/209 Immulox Modulator

Spray

Spray Proline-Rich Polypeptides From

Bovine Colostrums 8mg

Advanced Protein Systems 28-May-09

H2008/19454/790 Kamagra 100mg

Tablets

Tablets Sildenafil Citrate Equivalent To

Sildenafil 100mg

Ajanta Pharma Ltd., B-4/5/6,

Midc Area, Paithan 431 128;

India

7-Apr-09

H2008/19453/753 Kamagra 50mg Tablets Tablets Sildenafil Citrate Equivalent To

Sildenafil 50mg

Ajanta Pharma Ltd., B-4/5/6,

Midc, Area,Paithan 431 128;

India

7-Apr-09

H2009/20077/357 Mygra 100mg Tablets Tablets Sildenafil Citrate Equivalent To S Kant Healthcare Ltd; 6-Aug-09

H2009/20761/561 Nelgra-50 Tablets Tablets Sildenafil 50mg Tablets Universal Corporation 1-Sep-09

H2009/20747/653 Osteocerin Tablets Tablets Glucosamine Sulphate Kcl Usp

750mg, Methyl Sulphonyl

Methane (Msm) 250mg, Diacerein

50mg

Bravo For Medisel 29-Sep-09

H2008/16923/763 Osteonate Tablets Tablets Alendronate 10mg (As

Alendronate Sodium)

Egyptian Co. For Chemicals

And Pharmaceuticals (Adwia);

Egypt

7-Apr-09

H2009/19802/342 Phlebodia 600mg

Tablets

Tablets Diosmin 600mg Laboratoires Innothera 6-Aug-09

H2008/14881/706 Polygynax Vaginal

Capsules

Capsules Neomycin Sulphate 35000 I.U,

Polymixin Sulphate 35000 I.U,

Nystatin 100000 I.U

Innotech 7-Apr-09

H2009/20039/040 Powergra 100mg

Tablets

Tablets Sildenafil Citrate Equivalent To

Sildenafil 100mg

Umedica Laboratories Pvt Ltd,

Plot # 221, Gidc, Vapi – 396

195, Gujarat, India

7-Apr-09

H2009/20038/041 Powergra 50mg Tablets Tablets Sildenafil Citrate Equivalent To

Sildenafil 50mg

Umedica Laboratories Pvt Ltd,

Plot # 221, Gidc, Vapi – 396

195, Gujarat, India

7-Apr-09

H2009/18857/371 Procomil 5 Mg Tablets Tablets Yohimbine Hcl 5mg Walter Ritter Gmbh + 6-Aug-09

H2009/14025/657 Serratiopeptidase

Tablets

Tablets Serratiopeptidase 10mg Flamingo Pharmaceuticals Ltd;

India

29-Sep-09

H2009/16915/610 Sibutrim -10 Capsules Capsules Sibutramine Hcl Monohydrate

10mg


India

8-Sep-09

H2009/20556/404 Silybon-140mg Tablets Tablets Silymarin 140mg Micro Labs Ltd; India 6-Aug-09

H2009/19698/244 Stimol Sachets Oral Sachets Citrulline Malate 1.0gm Per

Sachet

Biocodex, 1 Avenue, Blaise

Pascal, 60000 Beauvais, France

28-May-09

H2009/19696/642 Stresam Capsules Capsules Etifoxine Hydrochloride 50mg Biocodex, 7 Avenue, Gallieni,

94250, Gentilly, France

22-Sep-09

H2008/19339/386 Sym Tablets Tablets Silymarin 200 Mg Getz Pharma (Pvt) Ltd; 29-


7-Apr-09

H2009/19797/274 Synflorix Injection Injection Saccharide 1mcg For Serotypes 1,

5, 6b, 7f, 9v, 14 And 23f Per

Ampoule


H2008/17944/593 Triokit Tablets Tablets Azithromycin Dihydrate Usp


Azithromycin 1gm (Sunset

Yellow), Fluconazole 150mg

(Brilliant Blue), Secnidazole

Tablets 1gm (Quinoline Yellow)

Zest Pharma 7-Apr-09



Registration

Per Kit

H2009/19277/073 Unihep Forte Tablets Tablets Ursodeoxycholic Acid Bp 300 Mg Win-Medicare Pvt. Ltd,

Modipuram -250 110 U.P.,

India

7-Apr-09

H2008/19764/822 Zegra-50 Tablets Tablets Sildenafil Citrate 50mg Benmed Pharm. Ltd 7-Apr-09

Anti-Diabetics

H2008/19302/970 Amaryl M 1mg/250mg

Tablets

Tablets Glimepiride 1mg, Metformin Hcl

250mg

Sanofi Aventis 7-Apr-09

H2009/18657/219 Benmet-500 Tablets Tablets Metformin Hcl Bp 500mg Bentley And Remington 28-May-09

H2009/18658/220 Benmet-850 Tablets Tablets Metformin Hcl Bp 850mg Bentley And Remington 28-May-09

H2008/19919/802 Comet 850mg Tablets Tablets Metformin Hydrochloride Bp

850mg

Square Pharmaceuticals Ltd-

Bangladesh

7-Apr-09

H2009/20987/644 Diagluc 80mg Tablets Tablets Gliclazide 80mg Cosmos Ltd 24-Sep-09

H2008/19768/661 Diapride-2 Tablets Tablets Glimepiride Usp 2mg Micro Labs Ltd 7-Apr-09

H2009/20323/348 Diapride-4 Tablets Tablets Glimepiride Usp 4mg Micro Labs Ltd 6-Aug-09

H2008/20089/982 Diarid-15 Tablets Tablets Pioglitazone Hcl 15mg Zest Pharma; India 7-Apr-09

H2008/20088/983 Diarid-30 Tablets Tablets Pioglitazone Hcl 30mg Zest Pharma; India 7-Apr-09

H2009/20874/527 Dibizide 5mg Tablets Tablets Glipizide Bp 5mg Microlabs 20-Aug-09

H2008/19716/628 Espadien Tablets Tablets Glibenclamide Bp 5mg,

Metformin Hcl 500mg

Wockhardt Ltd, Wockhardt

Towers, Bandra-Kurla

Complex, Mumbai India.

7-Apr-09

H2009/20241/321 Exermet 1000 Tablets Tablets Metformin Hydrochloride Bp

1000mg

Cipla Ltd 6-Aug-09

H2009/20242/322 Exermet 500 Tablets Tablets Metformin Hydrochloride Bp

500mg

Cipla Ltd 6-Aug-09

H2009/18639/291 Galvus 50 Mg Tablets Tablets Vildagliptin 50 Mg Norvatis Pharma 28-May-09

H2008/17862/854 Gansulin 30r Injection Injection Mixture Recombinant Human

Insulin 30/70 100 International

Units Per Vial

Tonghua Dongbao 7-Apr-09

H2008/17864/855 Gansulin N Injection Injection Recombinant Human Insulin

Isophane Injection 100

International Units Per Vial


H2008/17863/856 Gansulin R Injection Injection Regular Recombinant Human

Insulin 100 International Units Per

Vial


H2009/20508/282 Glibil 5 Tablets Tablets Glibenclamide Bp 5mg Hikma Pharmaceuticals 28-May-09

H2008/19828/712 Glimadien-1 Tablets Tablets Glimepiride Usp 1mg, Metformin

Hydrochloride Bp 500mg

Wockhardt-India 7-Apr-09

H2008/19829/713 Glimadien-2 Tablets Tablets Glimepiride Usp 2mg, Metformin

Hydrochloride Bp 500mg


H2008/19712/629 Glimauno-1 Tablets Tablets Glimepiride 1mg Wockhardt Ltd, Wockhardt



7-Apr-09

H2008/19711/630 Glimauno-2 Tablets Tablets Glimepiride Usp 2mg Wockhardt Ltd, Wockhardt



7-Apr-09




7-Apr-09




7-Apr-09

H2008/17615/915 Glinil M Tablets Tablets Metformin Hcl 500mg,

Glibenclamide 5.0mg

Cipla Ltd 7-Apr-09

H2008/18524/619 Glitas-G-2 Tablets Tablets Pioglitazone Hcl Equivalent To

Pioglitazone 15mg, Glimepiride

Usp 2mg

Intas Pharmaceuticals; India 7-Apr-09

H2009/20257/136 Glorion 1mg Tablets Tablets Glimepiride 1mg Hikma Pharmaceuticals 7-Apr-09




H2008/16892/556 Glucomet – N Tablets Tablets Glibenclamide Bp 5mg ;

Metformin Hcl Bp 500mg


H2008/18394/656 Gludown 500 Tablets Tablets Metformin Hydrochloride Bp 500

Mg

Lab & Allied Ltd 7-Apr-09

H2009/18180/242 Glycigon – M Tablets Tablets Gliclazide Bp 80mg, Metformin

Hydrochloride Ip 500mg

Aristo Pharmaceuticals Ltd 28-May-09

H2008/19182/857 Glycinorm-80 Tablets Tablets Gliclazide Bp 80mg Ipca Laboartories Ltd 7-Apr-09

H2008/18477/559 Limaryl 1mg Tablets Tablets Glimepiride Inn 1mg Popular Pharmaceuticals Ltd;

Bangladesh

7-Apr-09

H2008/18478/560 Limaryl 2mg Tablets Tablets Glimepiride Inn 2mg Popular Pharmaceuticals Ltd;

Bangladesh

7-Apr-09

H2009/17520/605 Lipimet 500mg Tablets Tablets Metformin Hcl Bp500mg Prism Life Sciences Ltd; India 8-Sep-09

H2009/17521/606 Lipimet 850mg Tablets Tablets Metformin Hcl Bp 850mg Prism Life Sciences Ltd; India 8-Sep-09


246


Registration

H2008/18867/376 Meftil 500 Mg Tablets Tablets Metformin Bp 500 Mg Fourrts (India) Lab Pvt. Ltd,

Vandalur Road, Kelambakkam

– 603 103, Tamil Nadu, India

7-Apr-09

H2008/19442/703 Melmet-1000 Sr

Tablets

Tablets Metformin Hcl Bp 1000mg Micro Labs Ltd, 92, Sipcot,

Hosur-635 126 India

7-Apr-09

H2008/19830/715 Metadien 500 Tablets Tablets Metformin Hydrochloride Bp

500mg


H2009/19228/147 Metcon Plus Tablets Tablets Metformin Hcl Bp 500mg,

Glibenclamide Bp 5mg

Efroze Chemical Ltd; Pakistan 7-Apr-09

H2009/20572/623 Metformin 850mg

Tablets

Tablets Metformin Hcl Bp 850mg S Kant Healthcare Ltd; India 15-Sep-09

H2009/20861/528 Metformin

Hydrochloride Tablets

Bp 850mg

Tablets Metformin Hydrochloride Bp

850mg

Aurobindo 20-Aug-09

H2008/18937/961 Metformin Tablets Bp

850mg

Tablets Metformin Hcl Bp 850mg Umedica; India 7-Apr-09

H2008/19178/885 Metswift 500mg

Tablets

Tablets Metformin Hcl Ep 500mg Ind-Swift Ltd., Global Business

Unit, Jawaharpur, Off Nh 21,

Derabassi, Distt. Mohali,

Punjab-140507. India

7-Apr-09

H2008/19252/886 Metswift 850 Mg

Tablets

Tablets Metformin Hcl Eur Ph 850 Mg Ind-Swift Ltd., Global Business

Unit, Jawaharpur, Off Nh 21,

Derabassi, Distt. Mohali,

Punjab-140507. India

7-Apr-09

H2008/19706/816 Nilgar 30mg Tablets Tablets Pioglitazone Hydrochloride


Pioglitazone 30mg

Mega Lifesciences 7-Apr-09

H2009/20145/148 Perglim M-1 Tablets Tablets Glimepiride Usp 1mg, Metformin

Hcl Bp 500mg


H2009/20146/149 Perglim M-2 Tablets Tablets Glimepiride Usp 2mg, Metformin

Hcl Bp 500mg


H2008/18010/988 Piosafe Mf 15/500

Tablets

Tablets Pioglitazone Hydrochloride

Equivalent To Pioglitazone 15mg,

Metformin Hydrochloride Bp

500mg

Aristo Pharma 7-Apr-09

H2008/19713/634 Piouno-15 Tablets Tablets Pioglitazone Hcl 15mg Wockhardt Ltd, Wockhardt



7-Apr-09




7-Apr-09




7-Apr-09

H2009/20746/626 Piozone-Mf Tablets Tablets Pioglitazone Hcl 15mg,

Metformin Hcl 500mg

Bravo 15-Sep-09

H2008/19520/478 Ranophage Od Tablets Tablets Metformin Hcl Bp 1gm Ranbaxy Laboratories; India 7-Apr-09

H2009/20364/208 Secrin 1mg Tablets Tablets Glimepiride Usp 1mg Square Pharmaceuticals

Ltd;Bangladesh

7-Apr-09

H2009/20365/202 Secrin 2mg Tablets Tablets Glimepiride Usp 2mg Square Pharmaceuticals

Ltd;Bangladesh

7-Apr-09

H2008/19718/1052 Tralomina 500 Tablets Tablets Metformin Hcl 500mg Medreich For Glaxosmithline 7-Apr-09

H2008/19717/1053 Tralomina 850 Tablets Tablets Metformin Hcl 850mg Medreich For Glaxosmithline 7-Apr-09

H2009/20478/270 Zolip Plus 15/500mg

Tablets

Tablets Pioglitazone Hcl 15mg,

Metformin Hcl 500mg

Getz Pharma Ltd; Pakistan 28-May-09

H2009/20479/271 Zolip Plus 15/850mg

Tablets

Tablets Pioglitazone Hcl 15mg,

Metformin Hcl 850mg

Getz Pharma Ltd; Pakistan 28-May-09

Veterinary Products

V2008/20029/050 Abezole 10%W/V

Suspension

Oral

Suspension

Albendazole 10%W/V Biodeal Laboratories Ltd;

Kenya

17-Sep-08

V2008/18310/052 Albafas 2.5%

Suspension

Oral

Suspension

Albendazole Bp 25mg Per Ml Norbrook 15-Oct-08

V2009/20475/012 Albendazole 10%

Suspension

Oral

Suspension

Albendazole 100mg Per Ml Metrovet (K) Ltd 1-Jul-09

V2009/20474/011 Albendazole 2.5%

Suspension

Oral

Suspension

Albendazole 25mg Per Ml Metrovet (K) Ltd 1-Jul-09

V2009/19140/035 Amprolium 20 Powder Oral Powder Amprolium Hcl 200mg Per Gram Nerix Pharma Ltd; Kenya 16-Sep-09

V2008/17995/058 Aniverm Forte

Suspension

Suspension Levamisole Hcl 30mg,

Oxyclozanide 60mg Per Ml

Vapco 26-Nov-08

V2008/18531/059 Aniverm Oral Drench Oral Drench Levamisole Hcl 15mg,

Oxyclozanide 30mg

Vapco 26-Nov-08

V2009/19906/001 Ashialben 10%

Suspension

Injection Albendazole Bp 100mg Per Ml Ashish Life Science 18-Feb-09

V2009/19905/002 Ashialben 2.5% Injection Albendazole Bp 25mg Per Ml Ashish Life Science 18-Feb-09



Registration

Suspension

V2008/19352/041 Ashialben 2500mg

Bolus

Tablets Albendazole Bp 2500mg Ashish Life Science Ltd; India 21-May-08

V2008/19353/042 Ashialben 3000mg

Bolus

Tablets Albendazole Bp 3000mg Ashish Life Science Ltd; India 21-May-08

V2008/19525/054 Ashialben 600 Bolus Tablets Albendazole Bp 600mg Ashish Life Science Ltd; India 22-Oct-08

V2008/19354/053 Ashiver 1% W/V

Injection

Injection Ivermectin Bp 10mg/Ml, Benzyl

Alcohol Bp 1.5%V/V

Ashish Life Ltd; India 15-Oct-08

V2009/19354/032 Ashiver 1% W/V

Injection

Injection Ivermectin Bp 10mg/Ml Ashish Life Sciences Pvt Ltd;

India

16-Sep-09

V2009/19438/019 Avi Ibd Inter Vaccine Vaccine Infectious Bursal Disease Virus

Strain Libdv Min 103.0 Eid50 Per

Vial

Laprovet; Hungary 1-Jul-09

V2009/19630/020 Avi Nd Hbi + Ib

Vaccine

Vaccine Newcastle Disease Virus ≥ 105.5

Eid50, Avian Infectious

Bronchitis Virus≥ 102.6 Eid50 Per

Vial

Ceva Phylaxia Veterinary 1-Jul-09

V2009/19437/006 Avi Nd Lasota Vaccine Injection Newcastle Disease Virus Lasota

Strain Min 105.5eid50 Per Dose

Laprovet; Hungary 4-Mar-09

V2008/18936/044 Bio-Tetra 10%

Injection

Injection Oxytetracycline Hcl 100mg Per

Ml

Bio-Pharmachemie Co. 30-Jul-08

V2009/19843/027 Bioxy Vet Powder Oral Powder Oxytetracycline Hcl Bp 5.5% Per

100g


Kenya

3-Aug-09

V2008/17965/045 Bupaquone Injection Injection Buparvaquone 50mg Per Ml Eagle Chemical Co. Ltd 13-Aug-08

V2009/19618/031 Cevac Fpl Vaccine Vaccine Fowl Pox Virus Strain Cutter

Min102.7eid50 Per Dose

Ceva Sante Animale; Hungary 16-Sep-09

V2009/19476/007 Coli-Am Powder Oral Powder Ampicillin Trihydrate 10g,

Colistin Sulfate 25000000

Eagle Vet 27-May-09

V2009/8338/033 Contavax Vaccine Vaccine Mycoplasma Mycoides Strain

T1/44 Min Titre 107 Per Dose

Kenya Veterinary Vaccines

Institute; Kenya

16-Sep-09

V2008/15315/064 Coopers New Milking

Salve (100g)

Cream Dichlorophene Bp 0.55% W/W,

Lanolin 2% W/W

Norbrook Epz E.A Ltd For

Cooper (K) Ltd

10-Sep-08

V2009/20033/038 Dabendazole 10%

Suspension

Suspension Albendazole 10% W/V Per Ml Dawa Ltd; Kenya 7-Oct-09

V2009/20032/037 Dabendazole 2.5%

Suspension

Suspension Albendazole 2.5% W/V Per Ml Dawa Ltd; Kenya 7-Oct-09

V2008/20017/051 Dexamethasone

Injection

Injection Dexamethasone 1.0mg, Sodium

Citrate 2.5mg, Phenol 1.5mg,

Lidocaine Hcl 5.0mg Per Ml

Eagle Vet Tech. Co. Ltd., 256-

Dugok-Ri, Shinam-Myun, Un,

Chungchongnam-Do, Korea.

17-Sep-08

V2008/13232/046 Diminaphen Injection Injection Diminazine Diaceturate 445mg,

Phenazone 550mg

Kela Laboratoria N.V., St

Lenaartseweg, 48 2320,

Hoogstraten, Belgium

13-Aug-08

V2008/19428/047 Eagle Long-Ps

Injection

Injection Penicillin G Benzathine 100,000

Iu, Procaine Pennicillin G 150,000

Iu, Dihydrostreptomycin Hcl 200

Mg Per Ml

Eagle Vet. Tech. Co. Ltd; 256-

46 Dugok, Shinam, Yesan,

Chungchongnam, Korea

13-Aug-08

V2009/19883/008 Eagle Salinomycin-60

Powder

Oral Powder Salinomycin 60mg Per Gram Eagle Vet 27-May-09

V2008/19123/065 E-Mectin Plus Injection Injection Ivermectin 1% W/V, Clorsulon

10% W/V

Eagle Vet Tech. Co. Ltd., 256-

46, Dugok-Ri, Shinam-Myun,

Yesan-Kun, Chungchongnam-

Do, Korea.

10-Sep-08

V2008/19124/060 E-Mectin-One Injection Injection Ivermectin 10gm Per Ml Eagle Vet Tech. Co. Ltd., 256,

Dugok-Ri, Shinam-Myun, Un,

Chungchongnam-Do, Korea

26-Nov-08

V2008/16087/043 Fencar 250mg Tablets Tablets Fenbendazole Bp 250 Mg Unversal Corporation Ltd;

Kenya

9-Jul-08

V2009/8330/021 Fowl Pox Vaccine Vaccine Freeze Dried Pellet Of Live

Attenuated Fowl Pox Virus Min

Titre Log10 3.5 Eid50 Per Vial


Institute

29-Jul-09

V2008/17982/031 Genta-100 Injection Injection Gentamicin Base 100 Mg/Ml Interchemie, Horsterweg 26a,

5811, Ac, Castenray, Holland

26-Mar-08

V2008/17984/032 Glucortin-20 Injection Injection Dexamethasone Sodium

Phosphate Equivalent To

Dexamethasone Base 20 Mg

Interchemie, Horsterweg 26a,


26-Mar-08

V2008/17981/033 Interflox-100 Injection Injection Edrofloxacin 100 Mg Interchemie, Horsterweg 26a,


26-Mar-08

V2008/17978/034 Intermectin Injection Injection Ivermectin 10 Mg/Ml Interchemie, Horsterweg 26a,


26-Mar-08

V2008/17985/035 Intertrim Injection Injection Sulphamethoxazole 200 Mg;

Trimethoprim 40 Mg Per Ml



26-Mar-08

V2008/13955/061 Lasota Newcastle

Disease Oral/Injectable

Vaccine

Oral/Injection

Vaccine

Newcastle Disease Virus, Lasota

Strain In Freeze-Dried Form At

Least 106.0 Eid50 Per Dose

Abic Ltd 26-Nov-08


248


Registration

V2009/18898/026 Levazan Poultry

Suspension

Suspension Levamisole Hcl Bp 7.5% W/V Per

100ml


Kenya

3-Aug-09

V2009/20872/036 Levimet 1.5% Drench Suspension Levamisole Hcl Bp (Vet) 15mg

Per Ml

Nerix Pharma Ltd; Kenya For

Merovet Kenya Ltd; Kenya

30-Sep-09

V2009/20321/017 Levimox Super

Suspension

Oral

Suspension

Levamisole Hcl 30mg,

Oxyclozanide Bp 60mg Per Ml

Nerix 1-Jul-09

V2009/8329/029 Lumpivax Vaccine Vaccine Live Attenuated ‘Neethling’ Strain

Of Lumpy Skin Disease Virus 104

Tcid50 Per Dose


Institute; Kenya

3-Aug-09

V2008/17979/036 Macrolan-200 Injection Injection Tylosin Base 200 Mg/Ml Interchemie, Horsterweg 26a,


26-Mar-08

V2009/20456/028 Muguga Cocktail Vaccine Kiambu 104 – 105, Muguga 104 –

105, Serengeti Transformed 104 –

105 Per Ml

International Livestock

Research Institute (Ilri); Kenya

3-Aug-09

V2009/20263/015 Murphyzole 10%

Suspension

Oral

Suspension

Albendazole Usp 100mg Per Ml Nerix For Murphy 1-Jul-09

V2009/19139/034 Nexotrim Powder Oral Powder Trimethoprim Bp 20mg,

Sulphamethoxazole Bp 100mg Per

Gram

Nerix Pharma Ltd; Kenya 16-Sep-09

V2009/16123/025 Norocarp Tablets 50mg Tablets Carprofen 50mg Norbrook Kenya Ltd; Kenya 3-Aug-09

V2008/18728/062 Noroprost Injection Injection Dinoprost 5mg With 0.25%W/V

Phenol Per Ml

Norbrook 3-Dec-08

V2008/10427/048 Opticlox Eye Ointment Eye Ointment Cloxacillin(As Benzathine Bp)

Vet 16.7%W/W

Norbrook 13-Aug-08

V2008/17980/037 Oxytocin-10 Injection Injection Oxytocin 10 Iu/Ml Interchemie, Horsterweg 26a,


26-Mar-08

V2009/18615/016 Penistrepto 20/20

Injection

Injection Benzyl Penicillin Procain 20

Million I.U, Dihydrostreptomycin

Sulphate 20g Per 100ml

Ceva Sante Animale 1-Jul-09

V2008/20223/055 Pestevac Vaccine Injection Live Attenuated Homologous

Peste Des Petit Ruminant Seed

Virus Strain Nig75/1

102.5(Tcid50) Per Dose

Jordan Bio-Industries Centre

(Jovac); Jordan

22-Oct-08

V2008/18860/056 Polvac Ndw Vaccine Injection Allantoic Liquid 106.5 Eid50 Per

1ml Dose

Fort Dodge 22-Oct-08

V2008/18861/057 Polvac Pox Ae Vaccine Injection Fowl Pox Viral Fluids ≥ 105.5

Eid50; Avian Encephalomyelitis

Viral Fluids ≥ 104.0 Eid50 Per Ml

Fort Dodge 22-Oct-08

V2009/17581/003 Pouvac In Lasota +

Bh120 Vaccine

Injection Ncd Viral Suspension ≥ 109.5

Eid50/Ml 0.045ml, Ib Viral

Suspension ≥ 108.0eid50/Ml

0.065ml Per Ml

Fort Dodge 18-Feb-09

V2009/17579/004 Pro Vac 3 Vaccine Injection Ibd Virus-Bearing Fluids ≥ 105.2

Tcid50/Dose 0.050ml, Ncd Virus-

Bearing Fluids ≥ 107.7

Eid50/Dose 0.050ml, Bronchitis

Virus-Bearing Fluids ≥ 106.9

Eid50/Dose 0.075ml Per 0.5ml


V2009/17580/005 Pro Vac 4 Vaccine Injection Ibd Virus-Bearing Fluids ≥ 6.5

Tcid50 0.050ml, Ncd Virus-

Bearing Fluids ≥ 9.0 Tcid50

0.050ml, Bronchitis Virus-Bearing

Fluids ≥ 8.0 Tcid50 0.075ml,

Retrovirus Strain #1733 Virus

Bearing Fluids ≥ 7.8 Tcid50

0.025ml, Retrovirus Strain #2408

Virus Bearing Fl


V2009/8334/022 S & G Vax Injection Injection Freeze Dried Pellet Of Live

Attenuated Kenya Sheep And

Goat Pox Virus Min Titre Log10

4.0 Tcid50 Per Ml


Institute

29-Jul-09

V2009/15335/040 Sulfran-Vet Powder Oral Powder Sulphamethoxazole B.P 1.0g,

Trimethoprim B.P 0.2g

Universal Corporation 2-Dec-09

V2009/21102/039 Sulprim Injection Injection Trimethoprim 80mg,

Sulphadiazine

Hilton Pharma 2-Dec-09

V2008/19241/049 Tetramisole Bolus Tablets Tetramisole Hydrochloride 600mg Universal Corporation Ltd;

Kenya

13-Aug-08

V2008/18453/066 Troxakel Injection Injection Nitroxinil 340mg Per Ml Kela N. V. 10-Sep-08

V2009/20553/030 Trypashish Injection Injection Isometamidium Chloride

Hydrochloride 0.5gm Per Vial

Ashish Life Sciences Pvt Ltd;

India

26-Aug-09

V2008/17983/038 Tryponil Injection Injection Diminazine Aceturate 1.05 Gm;

Phenazone 1.31gm



26-Mar-08

V2008/19475/063 Tylosin 200 Injection Injection Tylosin Tartarate 200mg Eaglevet 3-Dec-08

V2009/15084/041 Unipro-Vet Soluble Oral Powder Amprolium Hcl Usp 6g Universal Corporation 2-Dec-09



Registration

Powder

V2008/18098/040 V. H. + H – 120

Vaccine

Injection Newcastle V.H+ Bronchitis H-120

Strains Per Vial

Abic 30-Apr-08

V2009/17074/023 Veriben B12 Injection

2.36g

Injection Diminazene Diaceturate 1.05g,

Cyanocobalamin (Vit. B12)

0.6mg, Hydroxycobalamin (Vit.

B12a) 2.4mg Per Vial

Ceva Sante Animale 29-Jul-09

Dated the 18th August, 2010.

K. C. KOSKEI,

Registrar.

PRINTED AND PUBLISHED BY THE GOVERNMENT PRINTER, NAIROBI

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Transcript of Are You suprised - Amazon S3€¦ · Troikaa Pharmaceuticals Ltd; India 7-Apr-09 H2009/19167/707...