Drug Register (October 2019)
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S/NNDA REGISTRATION NUMBERLICENSE HOLDERLOCAL TECHNICAL REPRESENTATIVENAME OF DRUGMANUFACTURERCOUNTRY OF MANUFACTUREDOSAGE FORMPACK SIZEREGISTRATION DATE
1NDA/MAL/HHP/3115SHURIK LTDSHURIK LTDRHINO BALMMEHTA UNANI PHARMACY & CO LTD-INDIAINDIATOPICAL EXTERNAL OINTMENTS1.0X20.0 G CONTAINER,1.0X10.0 G CONTAINER07/11/2018
2NDA/MAL/HHP/5498AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDFIGURINAJANTA PHARMA LTD 31-0-AJANTA PHARMA LTD 31-0 MIDC INDUSTRIAL AREACHIKALTHANA 431210 DIST AURANGABAD MAHARASHTRAINDIAORAL SOLID ORDINARY CAPSULES1.0X6.0X10.0 CAPSULE BLISTER01/07/2000
3NDA/MAL/HHP/5500CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDAPTIZOOM SYRUPCHARAK PHARMA PVT LTD,-EVERGREEN INDUSTRIAL ESTATE, SHAUTI MILL LANE, MUMBAI-400011 INDIA INDIAORAL LIQUID ORDINARY SYRUPS1.0X1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE01/07/2000
4NDA/MAL/HHP/5502HIMALAYA DRUG COMPANYMETAPLUS (U) LIMITEDGASEXHIMALAYA DRUG COMPANY-27256287 INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X100.0 TABLET CONTAINER,1.0X25.0 TABLET CONTAINER (PHYSICIAN'S SAMPLE)01/07/2000
5NDA/MAL/HHP/5503ABACUS PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDAMODEX OINTMENTPOOJA DRUGS-POOJA DRUGSINDIATOPICAL EXTERNAL OINTMENTS1.0X25.0 G JAR01/07/2000
6NDA/MAL/HHP/5505VENUS REMIDIES LTDHARLEYS UGANDA LIMITEDAMPUCARE HERBAL OILPLANET HERBS LIFESCIENCES LIMITED -B-4 SARA INDUSTRIAL ESTATE, SELAQUI, DEHRADUN-248197, UTTARKHAND, INDIA INDIATOPICAL EXTERNAL LIQUIDS1.0X50.0 ML BOTTLE01/07/2008
7NDA/MAL/HHP/5506MONA LABVRUSHIK INVESTMENT LIMITEDSTOPAIN ROLL ONMONA LAB-20/2 CHAMPSI BHIMJI ROAD, THAKKAR IND. ESTATE UNIT 2, 2ND FLOOR, MAZGOAN MUMBAI-400010 INDIAORAL LIQUID ORDINARY LIQUIDS1.0X6.0 ML BOTTLE01/07/2009
8NDA/MAL/HHP/5515HIMALAYA DRUG COMPANYMETAPLUS (U) LIMITEDMENTATHIMALAYA DRUG COMPANY-27256287 INDIAINDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE01/07/2004
9NDA/MAL/HHP/5516MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDANCARE CAPSULESVITAL CARE PVT LTD-361-362 GIDC POR
RAMAGANDI VADODARA
INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER01/07/2001
10NDA/MAL/HHP/5517HIMALAYA DRUG COMPANYMETAPLUS (U) LIMITEDMENTATHIMALAYA DRUG COMPANY-27256287 INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X50.0 TABLET CONTAINER01/07/2004
11NDA/MAL/HHP/5518MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDPENODEX OINTMENTMEHTA UNANI PHARMACY & CO LTD-INDIAINDIATOPICAL EXTERNAL OINTMENTS1.0X20.0 G CONTAINER01/07/2007
12NDA/MAL/HHP/5519AJANTA PHARMA LTD 31-0ABACUS PHARMA (AFRICA) LIMITEDAPDYL-H, HERBAL COUGH SYRUPSAVERA PHARMACEUTICALS PVT LTD --H-39 & 40, M.I.D.C, WALUJ, AURANGABAD, INDIA. AJANTA PHARMA LTD - -31-0 M.I.D.C. INDUSTRIAL AREA CHIKALTHANA- AURANGABAD 431210 DIST AURANGABAD INDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE01/07/2004
13NDA/MAL/HHP/5520HIMALAYA DRUG COMPANYMETAPLUS (U) LIMITEDPILEXHIMALAYA DRUG COMPANY-27256287 INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X25.0 TABLET CONTAINER (PHYSICIAN'S SAMPLE),1.0X100.0 TABLET CONTAINER01/07/2001
14NDA/MAL/HHP/5522HIMALAYA DRUG COMPANYMETAPLUS (U) LIMITEDHIMCOLINHIMALAYA DRUG COMPANY-27256287 INDIAINDIATOPICAL EXTERNAL EMULSION GELS1.0X30.0 G TUBE01/07/2004
15NDA/MAL/HHP/5524HIMALAYA DRUG COMPANYMETAPLUS (U) LIMITEDHERBOLAXHIMALAYA DRUG COMPANY-27256287 INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X100.0 TABLET CONTAINER01/07/2000
16NDA/MAL/HHP/5527HIMALAYA DRUG COMPANYMETAPLUS (U) LIMITEDKOFLETHIMALAYA DRUG COMPANY-27256287 INDIAINDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE01/07/2000
17NDA/MAL/HHP/5528VIRCHOW HEALTHCARE PVT LTDSURGIPHARM (U) LIMITEDAQUAREST288,SIDCO ESTATE-AMBATTUR, CHENNAI 600 098, TAMIL NADU, INDIA INDIAORAL SOLID ORDINARY POWDERS1.0X10.0X765.0 MG SACHET01/07/2009
18NDA/MAL/HHP/5529HIMALAYA DRUG COMPANYMETAPLUS (U) LIMITEDLIV.52HIMALAYA DRUG COMPANY-27256287 INDIAINDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE (PHYSICIAN'S SAMPLE)01/07/2000
19NDA/MAL/HHP/5530HIMALAYA DRUG COMPANYMETAPLUS (U) LIMITEDLIV.52 TABLETSHIMALAYA DRUG COMPANY-27256287 INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X100.0 TABLET BOTTLE,1.0X25.0 TABLET BOTTLE01/07/2000
20NDA/MAL/HHP/5531HIMALAYA DRUG COMPANYMETAPLUS (U) LIMITEDRUMALAYAHIMALAYA DRUG COMPANY-27256287 INDIAINDIATOPICAL EXTERNAL CREAMS1.0X30.0 G TUBE01/07/2000
21NDA/MAL/HHP/5532MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDATMANANTHAN COLD RUBMETA UNANI PHARMACY & CO PVT-G 5524, GIDC, LODHIKA METODA, DIST RAJKOT, GUJARATI INDIANASAL TOPICAL LIQUID INHALATIONS1.0X12.0X1.0 G ROD01/07/2009
22NDA/MAL/HHP/5533HIMALAYA DRUG COMPANYMETAPLUS (U) LIMITEDRUMALAYAHIMALAYA DRUG COMPANY-27256287 INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X100.0 TABLET CONTAINER,1.0X25.0 TABLET CONTAINER (PHYSICIAN SAMPLE)01/07/2000
23NDA/MAL/HHP/5534SOUTH EGYPT DRUG INDUSTRIES CO. (SEDICO)WIDE SPECTRUM ENTERPRISES (U) LIMITEDEUCARBONSOUTH EGYPT DRUG INDUSTRIES CO. (SEDICO)-1ST INDUSTRIAL ZONE, 6 OCTOVER CITY, P.O. BOX 43 EGYPTORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2000
24NDA/MAL/HHP/5536ABACUS PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDMENTHO PLUS PAIN BALMEMAMI LTD-EMAMI LIMITED COLLEGE NAGAR ABHOYPUR, GUWAHATI 781031, ASSAM INDIA / EMAMI LIMITED PLOT NO 200 SANJAN -AMAGOAN ROAD DONGARI TALASARI INDIANASAL TOPICAL OINTMENTS1.0X24.0X3.5 ML VIAL,1.0X1.2 G JAR,1.0X4.0 G JAR,1.0X9.0 G JAR,1.0X30.0 G JAR,1.0X1.2 ML VIAL,1.0X4.0 ML VIAL,1.0X9.0 ML VIAL,1.0X30.0 ML BOTTLE01/07/2004
25NDA/MAL/HHP/5538HIMALAYA DRUG COMPANYMETAPLUS (U) LIMITEDSEPTILINHIMALAYA DRUG COMPANY-27256287 INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X100.0 TABLET CONTAINER01/07/2000
26NDA/MAL/HHP/5540HIMALAYA DRUG COMPANYMETAPLUS (U) LIMITEDSEPTILINHIMALAYA DRUG COMPANY-27256287 INDIAINDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE01/07/2000
27NDA/MAL/HHP/5546CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDPAEDRITONE SYRUPCHARAK PHARMA PVT LTD,-EVERGREEN INDUSTRIAL ESTATE, SHAUTI MILL LANE, MUMBAI-400011 INDIA INDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE01/07/2015
28NDA/MAL/HHP/5547SHURIK LTDSHURIK LTDMENTHOSIL COUGH DROPMEHTA HERBALS PVT LTD-INDIAINDIAORAL SOLID ORDINARY LOZENGES1.0X35.0X2.0 LOZENGE STRIP01/07/2001
29NDA/MAL/HHP/5548EMAMI LTDJEET PHARMACEUTICALS LIMITEDHIMANI FAST HERBAL PAIN RELIEF OINTMENTEMAMI LTD-EMAMI LIMITED COLLEGE NAGAR ABHOYPUR, GUWAHATI 781031, ASSAM INDIA / EMAMI LIMITED PLOT NO 200 SANJAN -AMAGOAN ROAD DONGARI TALASARI INDIATOPICAL EXTERNAL OINTMENTS1.0X4.0 ML BOTTLE,1.0X25.0 ML BOTTLE,1.0X50.0 ML BOTTLE,1.0X12.0 ML BOTTLE01/07/2000
30NDA/MAL/HHP/5549HIMALAYA DRUG COMPANYMETAPLUS (U) LIMITEDBONISAN LIQUIDHIMALAYA DRUG COMPANY-27256287 INDIAINDIAORAL LIQUID ORDINARY LIQUIDS1.0X120.0 ML BOTTLE01/07/2000
31NDA/MAL/HHP/5550CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDGUM TONE GELCHARAK PHARMA PVT LTD,-EVERGREEN INDUSTRIAL ESTATE, SHAUTI MILL LANE, MUMBAI-400011 INDIA INDIAORAL TOPICAL GELS AND SOLS1.0X50.0 G TUBE01/07/2015
32NDA/MAL/HHP/5551EMAMI LTDJEET PHARMACEUTICALS LIMITEDHIMANI FAST HERBAL PAIN BALMEMAMI LTD-EMAMI LIMITED COLLEGE NAGAR ABHOYPUR, GUWAHATI 781031, ASSAM INDIA / EMAMI LIMITED PLOT NO 200 SANJAN -AMAGOAN ROAD DONGARI TALASARI INDIATOPICAL EXTERNAL OINTMENTS1.0X25.0 ML BOTTLE01/07/2015
33NDA/MAL/HHP/5553ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDMENTHOXYL DOUBLE ACTION HERBAL COUGH LOZENGESLEAMARK HEALTHCAREPVT LTD-SARKHEJ-BAVLA HIGHWAY MATODA AHMEDABADINDIAORAL SOLID ORDINARY LOZENGES1.0X10.0X2.0 LOZENGE STRIP,1.0X50.0X2.0 LOZENGE STRIP01/07/2009
34NDA/MAL/HHP/5554EMAMI LTDJEET PHARMACEUTICALS LIMITEDHIMANI FIRST HERBAL PAIN RELIF SPRAYEMAMI LTD-EMAMI LIMITED COLLEGE NAGAR ABHOYPUR, GUWAHATI 781031, ASSAM INDIA / EMAMI LIMITED PLOT NO 200 SANJAN -AMAGOAN ROAD DONGARI TALASARI INDIATOPICAL EXTERNAL PRESSURISED AEROSOLS1.0X150.0 ML CANNISTER01/07/2015
35NDA/MAL/HHP/5556SHURIK LTDSHURIK LTDCOLD RUB VAPORIZINGMETHA UNANI PHARMACY-INDIAINDIANASAL TOPICAL EMULSION OINTMENTS1.0X5.0 G CONTAINER,1.0X9.0 G CONTAINER,1.0X10.0 G CONTAINER01/07/2000
36NDA/MAL/HHP/5557BETA HEALTH CARE INTERNATIONAL LTDBETA HEALTHCARE UGANDA LIMITEDNEW BETA GRIPE WATERSYDLER REMEDIES PVT LTD-M-190 MIDC WALUJ AURANGABAD 431136 BETA HEALTHCARE INTERNATIONAL LTD--PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA,NAIROBI,KENYA INDIAORAL LIQUID ORDINARY LIQUIDS1.0X120.0 ML BOTTLE,1.0X100.0 ML BOTTLE01/07/2014
37NDA/MAL/HHP/5558EMAMI LTDJEET PHARMACEUTICALS LIMITEDHIMANI FIRST HERBAL VAPOUR RUBEMAMI LTD-EMAMI LIMITED COLLEGE NAGAR ABHOYPUR, GUWAHATI 781031, ASSAM INDIA / EMAMI LIMITED PLOT NO 200 SANJAN -AMAGOAN ROAD DONGARI TALASARI INDIATOPICAL EXTERNAL OTHER OINTMENTS1.0X25.0 ML JAR01/07/2015
38NDA/MAL/HHP/5559SHURIK LTDSHURIK LTDSTAR SKIN OINTMENTMEHTA UNANI PHARMACY & CO LTD-INDIAINDIATOPICAL EXTERNAL OINTMENTS1.0X12.0 G TUBE01/07/2001
39NDA/MAL/HHP/5560AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDSTAMINAAJANTA PHARMA LTD-31-0, M.I.D.C. CHIKALTHANA, CHIKALTHANA, AURANGABAD, MAHARASHTRA STATE, INDIA INDIAORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER01/07/2000
40NDA/MAL/HHP/5561MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDCOLDDROP MEDICATED COUGH DROPSMEHTA HERBALS PVT LTD-AMRUTMANTHAN HOUSE, SADAR,RAJKOT,GUJARAT - 360 001,INDIA, RAJKOT, GUJARAT 360001, INDIA INDIAORAL SOLID ORDINARY LOZENGES1.0X1.0X100.0 LOZENGE CARTON01/07/2009
41NDA/MAL/HHP/5563HIMALAYA DRUG COMPANYMETAPLUS (U) LIMITEDCYSTONEHIMALAYA DRUG COMPANY-27256287 INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X100.0 TABLET CONTAINER01/07/2001
42NDA/MAL/HHP/5564AIL HEALTH CAREVRUSHIK INVESTMENT LIMITEDFRESH HERBAL COUGH SYRUPAIL HEALTH CARE-816/1 RAKANPUR KALOL GENDHINAGAR GUJRATINDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE01/07/2014
43NDA/MAL/HHP/5565ABACUS PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDDENTEX TOOTHACEPOOJA DRUGS-POOJA DRUGSINDIATOPICAL EXTERNAL LIQUIDS1.0X5.0 ML BOTTLE01/07/2000
44NDA/MAL/HHP/5569HIMALAYA DRUG COMPANYMETAPLUS (U) LIMITEDDIAREXHIMALAYA DRUG COMPANY-27256287 INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X100.0 TABLET CONTAINER01/07/2000
45NDA/MAL/HHP/5570PANACEA BIOTEC LTDABACUS PHARMA (AFRICA) LIMITEDSITCOMPANACEA BIOTEC LTD--MALPUR, BADDI, TEHSIL, NALAGARH, DIST. SOLAN HIMACHAL PRADESH – 173 205 INDIAORAL SOLID ORDINARY TABLETS1.0X2.0X7.0 TABLET BLISTER01/07/2013
46NDA/MAL/HHP/5571ABACUS PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDDRAGON LIQUID BALMAMRUTANJAN HEALTH CARE LIMITED-PLOT NO 37,38&39, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR VILLAGE, THIRUPORUR TALUK, KANCHEEPURAM DISTRICT 603110, INDIA INDIATOPICAL EXTERNAL OTHER OINTMENTS1.0X10.0 ML CONTAINER,1.0X5.0 ML CONTAINER01/07/2004
47NDA/MAL/HHP/5572CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDVIGOMAX FORTE CHARAK PHARMA PVT LTD-JAURASI ROAD,PAUTI VILLAGE,G.T ROAD,SAMALKHA-132 101 INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X20.0 TABLET BLISTER01/07/2011
48NDA/MAL/HHP/5574AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDNEW PINKOO GRIPE WATERAJANTA PHARMA LIMITED-31-0 MIDC INDUSTRIAL AREA CHIKALTHANA 431210 DIST AURANGABAD MAHARASHTRA STATEINDIAORAL LIQUID ORDINARY LIQUIDS1.0X120.0 ML BOTTLE01/07/2009
49NDA/MAL/HHP/5576SHURIK LTDSHURIK LTDNO SCAR CREAMMETHA UNANI PHARMACY-METHA UNANI PHARMACY G-524 LODHIKA, G.I.D.C METODA INDIATOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE01/07/2007
50NDA/MAL/HHP/5580MEGA LIFESCIENCES (AUSTRALIA) PTY LTDABACUS PHARMA (AFRICA) LIMITEDEUGICA SYRUPDHG PHARMACEUTICALJOINT-STOCK COMPANY (DHG PHARMA)-NO. 288 BIS, NGUYEN VAN CN STREET, AN HOA WARD, NINHKIEN DISTRICT, CAN THO CITY
VIETNAMORAL LIQUID ORDINARY SYRUPS1.0X60.0 ML BOTTLE01/07/2016
51NDA/MAL/HHP/5583HIMALAYA DRUG COMPANYMETAPLUS (U) LIMITEDEVECAREHIMALAYA DRUG COMPANY-27256287 INDIAINDIAORAL SOLID ORDINARY CAPSULES1.0X30.0 CAPSULE CONTAINER01/07/2001
52NDA/MAL/HHP/5593ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDSYDLER GRIPE WATERSYDLER REMEDIES PVT LTD -M-190, M.I.D.C, WALUJ, AURANGABAD 431 136 (M.S), INDIA.

INDIAORAL LIQUID ORDINARY LIQUIDS1.0X120.0 ML BOTTLE01/07/2010
53NDA/MAL/HHP/5595HIMALAYA DRUG COMPANYMETAPLUS (U) LIMITEDTENTEX ROYALHIMALAYA DRUG COMPANY-27256287 INDIAINDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER07/01/2004
54NDA/MAL/HHP/5597CIRON DRUGS & PHARMACEUTICALS PVT LTDRENE PHARMACY LTDTOOCHE DROPSCIRON DRUGS AND PHARMACEUTICALS PVT LTD-N-118 M.I.D.C, TAAPUR,BOISAR,DIST.THANE MAHARASHTRA INDIA INDIAORAL TOPICAL DROPS1.0X10.0 ML BOTTLE01/07/2014
55NDA/MAL/HHP/5613DR. KIM AYURVEDIC PHARMACYJ.P IMPEX PHARMACY (U) LTDSMOOTH COUGH DROPSDR KIM AYURVEDIC PHARMACY-INDIAINDIAORAL SOLID ORDINARY LOZENGES1.0X100.0X2.0 LOZENGE STRIP01/07/2005
56NDA/MAL/HHP/5616HIMALAYA DRUG COMPANYMETAPLUS (U) LIMITEDV-GELHIMALAYA DRUG COMPANY-27256287 INDIAINDIATOPICAL EXTERNAL GELS AND SOLS1.0X30.0 G TUBE07/01/2004
57NDA/MAL/HHP/5618SHURIK LTDSHURIK LTDVYBRANTVITAL CARE-INDIAINDIAORAL SOLID ORDINARY CAPSULES5.0X10.0 CAPSULE BLISTER01/07/2000
58NDA/MAL/HHP/5620UNIQUE PHARMACEUTICAL LABORATORIESPLANET PHARMACEUTICALS UGANDA LTDZECUF COLD RUBUNIQUE PHARMACEUTICAL LABORATORIES-PLOT NO. 4 PASE IV, GIDC PANOLI -394 116
GUJARAT INDIA
INDIATOPICAL EXTERNAL OINTMENTS1.0X20.0 G CONTAINER01/07/2009
59NDA/MAL/HHP/5623UNIQUE PHARMACEUTICAL LABORATORIESTATA UGANDA LIMITEDZECUF HERBAL COUGH LOZENGES(FRUITY FLAVOUR)UNIQUE PHARMACEUTICAL LABORATORIES. -SURVEY NO.101/2 AND 102/1,DAMAN INDUSTRIAL ESTATE, AIRPORT ROAD, KADAIYA, DAMAN-396 210 INDIA INDIAORAL SOLID ORDINARY LOZENGES1.0X5.0X4.0 LOZENGE STRIP01/07/2005
60NDA/MAL/HHP/5629UNIQUE PHARMACEUTICAL LABORATORIESTATA UGANDA LIMITEDZECUF HERBAL COUGH LOZENGES(ORANGE FLAVOUR)UNIQUE PHARMACEUTICAL LABORATORIES. -SURVEY NO.101/2 AND 102/1,DAMAN INDUSTRIAL ESTATE, AIRPORT ROAD, KADAIYA, DAMAN-396 210 INDIA INDIAORAL SOLID ORDINARY LOZENGES1.0X5.0X4.0 LOZENGE STRIP01/07/2005
61NDA/MAL/HHP/5630UNIQUE PHARMACEUTICAL LABORATORIESTATA UGANDA LIMITEDZECUF HERBAL COUGH REMEDYUNIQUE PHARMACEUTICAL LABORATORIES --PLOT NO. 215-219 AND 304 - 308 G.I.D.C. INDUSTRIAL AREA,PANOLI—394 116,INDIA. INDIAORAL LIQUID ORDINARY LIQUIDS1.0X100.0 ML BOTTLE01/07/2000
62NDA/MAL/HHP/5631UNIQUE PHARMACEUTICAL LABORATORIESTATA UGANDA LIMITEDZECUF HERBAL COUGH LOZENGES(LEMON)UNIQUE PHARMACEUTICAL LABORATORIES. -SURVEY NO.101/2 AND 102/1,DAMAN INDUSTRIAL ESTATE, AIRPORT ROAD, KADAIYA, DAMAN-396 210 INDIA INDIAORAL SOLID ORDINARY LOZENGES1.0X5.0X4.0 LOZENGE STRIP01/07/2014
63NDA/MAL/HHP/6850WILSHIRE LABORATORIES (PVT) LTDHEALTHCARE LTD.BENZIM NATURAL SYRUP 120MLWILSHIRE LABORATORIES LIMITED-124/1-INDUSTRIAL ESTATE, KOT LAKHPAT, LAHORE, PAKISTAN PAKISTANORAL LIQUID ORDINARY SYRUPS1 X 120ML03/12/2016
64NDA/MAL/HHP/6852WILSHIRE LABORATORIES (PVT) LTDHEALTHCARE LTD.DE-FLU SYRUP 120MLWILSHIRE LABORATORIES LIMITED-124/1-INDUSTRIAL ESTATE, KOT LAKHPAT, LAHORE, PAKISTAN INDIAORAL LIQUID ORDINARY SYRUPS1 X 120ML03/12/2016
65NDA/MAL/HHP/6853WILSHIRE LABORATORIES (PVT) LTDHEALTHCARE LTD.LIV-LONG TABLETWILSHIRE LABORATORIES LIMITED-124/1-INDUSTRIAL ESTATE, KOT LAKHPAT, LAHORE, PAKISTAN PAKISTANORAL SOLID ORDINARY TABLETS1X3X10 BLISTERS01/07/2016
66NDA/MAL/HHP/6863KREMOINT PHARMA PVT.LTDGOOD DAY PHARMACY LIMITEDKOFFENGES LOZENGES (HONEY & LEMON FLAVOUR)KREMOINT PHARMA PVT LTD - -RAGHAV ESTATE, K.S.S.I.D.C. INDUSTRIAL ESTATE AREA, SHIGGAON ROAD, SAVANUR 581118, DIST: HAVERI, KARNATAKA, INDIA INDIAORAL SOLID ORDINARY LOZENGES1.0X5.0X4.0 LOZENGE BLISTER,1.0X10.0X6.0 LOZENGE BLISTER01/07/2014
67NDA/MAL/HHP/6915GREAT INDIA INDUSTRIAL & PHARAMCEUTICALS LABORATORIESANDYCO PHARMACY (UGANDA) LTDGIPLA GRIPE WATERGREAT INDIA -19 SUN MILL COMPOUNDINDIAORAL LIQUID ORDINARY LIQUIDS1.0X135.0 ML BOTTLE01/07/2014
68NDA/MAL/HHP/7926HOVID BERHADUNITED HEALTHCARE DISTRIBUTORS LTDHOVID GINGKOHOVID BERHAD-121, JALAN TUNKU ABDUL RAHMAN, 30010 IPOH, PERAK, MALAYSIA MALAYSIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2011
69NDA/MAL/HHP/7929WOCKHARD LTDSTAR PHARMACEUTICALS LTDMANIX HERBAL CAPSULESTIRUPATI LIFESCIENCES-NAHAN ROAD, PAONTA SAHIB, DISTT. SIRMOUR HIMACHAL PRADESH-173025, INDIA INDIAORAL SOLID ORDINARY CAPSULES1.0X2.0X10.0 CAPSULE BLISTER01/07/2015
70NDA/MAL/HHP/7931DAR AL DAWA DEVELOPMENT AND INVESTMENT CO. LTDGAMA PHARMACEUTICALS (U) LIMITEDLIBLAB SYRUPDAR AL DAWA DEVELOPMENT AND INVESTMENT CO. LTD,-NA’UR PRINCE HASHEM BIN AL-HUSSEIN STREET, AMMAN, JORDAN. JORDANORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE01/07/2012
71NDA/MAL/HHP/7934STAR PHARMACEUTICALS LTDSTAR PHARMACEUTICALS LTDSENSUR RUBEFACIENTGLENMARK PHARMACEUTICAL LIMITED-61-62 COMPOUND, DEWAS NAKA, LASUDIA MORI INDIATOPICAL EXTERNAL OINTMENTS1.0X30.0 G TUBE01/07/2015
72NDA/MAL/HHP/7936SQUARE HERBAL AND NUTRACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDGILOBA 60 CAPSULESQUARE HERBAL AND NUTRACEUTICALS LTD-48, MOHAKHALI COMMERCIAL AREA, DHAKA-1212 BANGLADESHORAL SOLID ORDINARY CAPSULES1.0X5.0X6.0 CAPSULE BLISTER01/07/2013
73NDA/MAL/HHP/7937GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDSENSUR OILGLENMARK PHARMACEUTICAL LIMITED-61-62 COMPOUND, DEWAS NAKA, LASUDIA MORI INDIATOPICAL EXTERNAL LIQUIDS1.0X10.0 ML VIAL01/07/2015
74NDA/MAL/HHP/7938SQUARE HERBAL AND NUTRACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDSILYBIN 140SQUARE HERBAL AND NUTRACEUTICALS LTD -48 MOHAKHALI COMERCIAL AREA, DHAKA-1212 BANGLADESHORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER01/07/2013
75NDA/MAL/HHP/7939SQUARE HERBAL AND NUTRACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDGINTEXSQUARE HERBAL AND NUTRACEUTICALS LTD-48, MOHAKHALI COMMERCIAL AREA, DHAKA-1212 BANGLADESHORAL SOLID ORDINARY CAPSULES1.0X5.0X6.0 CAPSULE STRIP01/07/2014
76NDA/MAL/HHP/7940GLENMARK PHARMACEUTICALS LTDSTAR PHARMACEUTICALS LTDSENSUR LOTIONGLENMARK PHARMACEUTICAL LIMITED-61-62 COMPOUND, DEWAS NAKA, LASUDIA MORI INDIATOPICAL EXTERNAL OTHER CREAMS1.0X50.0 ML BOTTLE01/07/2015
77NDA/MAL/HHP/7942MEGA LIFESCIENCES PUBLIC COMPANY LTDABACUS PHARMA (AFRICA) LIMITEDEUGICA FORTDHG PHARMACEUTICALJOINT-STOCK COMPANY (DHG PHARMA)-NO. 288 BIS, NGUYEN VAN CN STREET, AN HOA WARD, NINHKIEN DISTRICT, CAN THO CITY
THAILANDORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER01/07/2016
78NDA/MAL/HHP/7947UNIQUE PHARMACEUTICAL LABORATORIES. (A DIVISION OF J.B. CHEMICALS AND PHARMACEUTICALS LTD)TATA UGANDA LIMITEDZECUF HERBAL COUGH LOZENGES(HONEY LEMON)UNIQUE PHARMACEUTICAL LABORATORIES. -SURVEY NO.101/2 AND 102/1,DAMAN INDUSTRIAL ESTATE, AIRPORT ROAD, KADAIYA, DAMAN-396 210 INDIA INDIAORAL SOLID ORDINARY LOZENGES1.0X5.0X4.0 LOZENGE STRIP01/07/2014
79NDA/MAL/HHP/7949UNIQUE PHARMACEUTICAL LABORATORIES. (A DIVISION OF J.B. CHEMICALS AND PHARMACEUTICALS LTD)TATA UGANDA LIMITEDZECUF HERBAL COUGH (SUGAR FREE)UNIQUE PHARMACEUTICAL LABORATORIES --PLOT NO. 215-219 AND 304 - 308 G.I.D.C. INDUSTRIAL AREA,PANOLI—394 116,INDIA. INDIAORAL SOLID ORDINARY LOZENGES1.0X2.0X12.0 LOZENGE CONTAINER01/07/2016
80NDA/MAL/HHP/7950UNIQUE PHARMACEUTICAL LABORATORIES. (A DIVISION OF J.B. CHEMICALS AND PHARMACEUTICALS LTD)TATA UGANDA LIMITEDZECUF HERBAL COUGH LOZENGES(RASPBERRY)UNIQUE PHARMACEUTICAL LABORATORIES. -SURVEY NO.101/2 AND 102/1,DAMAN INDUSTRIAL ESTATE, AIRPORT ROAD, KADAIYA, DAMAN-396 210 INDIA INDIAORAL SOLID ORDINARY LOZENGES1.0X5.0X4.0 LOZENGE STRIP01/07/2014
81NDA/MAL/HHP/7954UNIQUE PHARMACEUTICAL LABORATORIES. (A DIVISION OF J.B. CHEMICALS AND PHARMACEUTICALS LTD)TATA UGANDA LIMITEDZECUF HERBAL COUGH LOZENGES(PINEAPPLE)UNIQUE PHARMACEUTICAL LABORATORIES. -SURVEY NO.101/2 AND 102/1,DAMAN INDUSTRIAL ESTATE, AIRPORT ROAD, KADAIYA, DAMAN-396 210 INDIA INDIAORAL SOLID ORDINARY LOZENGES1.0X5.0X4.0 LOZENGE STRIP01/07/2014
82NDA/MAL/HHP/7955KREMOINT PHARMA PVT.LTDGOOD DAY PHARMACY LIMITEDDICLODAY ROLL-ONKREMOINT PHARMA PVT LTD-B-8,ADDITIONAL AMBERNATH MIDC, AMBERNATH (E),DIST: THANE 421506, INDIA INDIATOPICAL EXTERNAL EMULSIONS1.0X50.0 ML BOTTLE03/12/2016
83NDA/MAL/HHP/7956UNIQUE PHARMACEUTICAL LABORATORIES. (A DIVISION OF J.B. CHEMICALS AND PHARMACEUTICALS LTD)TATA UGANDA LIMITEDZECUF HERBAL (SUGAR FREE)UNIQUE PHARMACEUTICAL LABORATORIES. -SURVEY NO.101/2 AND 102/1,DAMAN INDUSTRIAL ESTATE, AIRPORT ROAD, KADAIYA, DAMAN-396 210 INDIA INDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE01/07/2015
84NDA/MAL/HHP/7958KREMOINT PHARMA PVT.LTDGOOD DAY PHARMACY LIMITEDKOFFENGES(GINGER FLAVOUR)KREMOINT PHARMA PVT LTD - -RAGHAV ESTATE, K.S.S.I.D.C. INDUSTRIAL ESTATE AREA, SHIGGAON ROAD, SAVANUR 581118, DIST: HAVERI, KARNATAKA, INDIA INDIAORAL SOLID ORDINARY LOZENGES1.0X5.0X4.0 LOZENGE BLISTER,1.0X10.0X6.0 LOZENGE BLISTER01/12/2016
85NDA/MAL/HHP/7959BHARGAVA PHYTOLAB PVT. LTDPLANET PHARMACEUTICALS UGANDA LTDTONIPHIBBHARGAVA PHYTOLAB PVT. LTD -E-1216, PHASE – 1, EXTN. GHATAL, BHIWADI INDUSTRIAL AREA, BHIWADI (RAJ.) INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X6.0 TABLET BLISTER01/07/2015
86NDA/MAL/HHP/7960KREMOINT PHARMA PVT.LTDGOOD DAY PHARMACY LIMITEDKOFFENGES(ORANGE FLAVOUR)KREMOINT PHARMA PVT LTD - -RAGHAV ESTATE, K.S.S.I.D.C. INDUSTRIAL ESTATE AREA, SHIGGAON ROAD, SAVANUR 581118, DIST: HAVERI, KARNATAKA, INDIA INDIAORAL SOLID ORDINARY LOZENGES1.0X5.0X4.0 LOZENGE BLISTER,1.0X10.0X6.0 LOZENGE BLISTER01/12/2016
87NDA/MAL/HHP/7961KREMOINT PHARMA PVT.LTDGOOD DAY PHARMACY LIMITEDKOFFENGES LOZENGES MINTKREMOINT PHARMA PVT LTD - -RAGHAV ESTATE, K.S.S.I.D.C. INDUSTRIAL ESTATE AREA, SHIGGAON ROAD, SAVANUR 581118, DIST: HAVERI, KARNATAKA, INDIA INDIAORAL SOLID ORDINARY LOZENGES1.0X5.0X4.0 LOZENGE BLISTER,1.0X10.0X6.0 LOZENGE BLISTER01/07/2016
88NDA/MAL/HHP/7962GOODDAY P HARMACYL IMITEDGOOD DAY PHARMACY LIMITEDKREMOINT BABY CARE GRIPE WATERKREMOINT PHARMA PVT LTD---B-8 ADDITIONAL AMBERNATH MIDC OPP. ANAND NAGAR POLICE CHECK POST AMBERNATH (E) DIST THANE 421 506INDIAORAL LIQUID ORDINARY LIQUIDS1.0X135.0 ML BOTTLE01/07/2015
89NDA/MAL/HHP/7965BHARGAVA PHYTOLAB PVT. LTDPLANET PHARMACEUTICALS UGANDA LTDCO-EXBHARGAVA PHYTOLAB PVT. LTD -E-1216, PHASE – 1, EXTN. GHATAL, BHIWADI INDUSTRIAL AREA, BHIWADI (RAJ.) INDIA INDIAORAL LIQUID ORDINARY LIQUIDS1.0X100.0 ML BOTTLE01/07/2017
90NDA/MAL/HHP/7966BHARGAVA PHYTOLAB PVT LTDPLANET PHARMACEUTICALS UGANDA LTDKIDFLAMEBHARGAVA PHYTOLAB PVT LTD-B-92, SECTOR – 2 , NOIDA – 201301, U.P. ( INDIA) INDIAORAL SOLID ORDINARY TABLETS1.0X4.0X5.0 TABLET BLISTER01/07/2015
91NDA/MAL/HHP/7972MONA LABVRUSHIK INVESTMENT LIMITEDSTOPAIN BALMMONA LAB-20/2 CHAMPSI BHIMJI ROAD, THAKKAR IND. ESTATE UNIT 2, 2ND FLOOR, MAZGOAN MUMBAI-400010 INDIATOPICAL EXTERNAL OINTMENTS1.0X9.0 G JAR,1.0X5.0 G CONTAINER01/07/2009
92NDA/MAL/HHP/7974WILSHIRE LABORATORIES (PVT) LTDHEALTHCARE LTD.APPERIZE SYRUP 120MLWILSHIRE LABORATORIES (PVT) LTD-124/1 INDUSTRIAL AREA, KOT LAKHPAT LAHORE PAKISTAN PAKISTANORAL LIQUID ORDINARY SYRUPS1.0X120.0 ML BOTTLE
93NDA/MAL/HHP/7975MONA LABVRUSHIK INVESTMENT LIMITEDSTOPAIN INHALERMONA LAB-20/2 CHAMPSI BHIMJI ROAD, THAKKAR IND. ESTATE UNIT 2, 2ND FLOOR, MAZGOAN MUMBAI-400010 INDIANASAL SYSTEMIC UNIT DOSE AEROSOLS1.0X1.0 CARTON CONTAINER01/07/2009
94NDA/MAL/HHP/8070LEXINE TECHNOCHEM PVT LTDMUKWANO PHARMACEUTICALS LIMITEDKWIK PAIN RELIEVING CREAMLEXINE TECHNOCHEM PVT LTD.-INDIAINDIATOPICAL EXTERNAL CREAMS1.0X30.0 G TUBE28/07/2018
95NDA/MAL/HHP/8071EVA PHARMAWIDE SPECTRUM ENTERPRISES (U) LIMITEDMOOVE MASSAGE CREAMEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT EGYPTTOPICAL EXTERNAL LOTIONS1.0X1.0X40.0 G TUBE01/07/2017
96NDA/MAL/HHP/8094BHARGAVA PHYTOLAB PVT. LTDPLANET PHARMACEUTICALS UGANDA LTDPOSTORALBHARGAVA PHYTOLAB PVT. LTD -E-1216, PHASE – 1, EXTN. GHATAL, BHIWADI INDUSTRIAL AREA, BHIWADI (RAJ.) INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X2.0X15.0 TABLET BLISTER01/07/2017
97NDA/MAL/HHP/8220AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDNOCOLICAJANTA PHARMA LTD - -31-0 M.I.D.C. INDUSTRIAL AREA CHIKALTHANA- AURANGABAD 431210 DIST AURANGABADINDIAORAL LIQUID ORDINARY LIQUIDS1.0X120.0 ML BOTTLE01/07/2017
98NDA/MAL/HHP/8289HIMALAYA DRUG COMPANYMETAPLUS (U) LIMITEDGERIFORTEHIMALAYA DRUG COMPANY-27256287 INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X100.0 TABLET CONTAINER01/07/2000
99NDA/MAL/HHP/8379CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDM2 TONE TABLET CHARAK PHARMA PVT LTD-INDUSTRIALESTATE, SHAUTI MILL LANE, MUMBAI-400011 INDIAORAL SOLID ORDINARY TABLETS1.0X60.0 TABLET BOTTLE20/09/2017
100NDA/MAL/HHP/8385GULF PHARMACEUTICAL INDUSTRIES(JULPHAR).GAMA PHARMACEUTICALS (U) LIMITEDMEBOSCAR OINTMENTGULF PHARMACEUTICAL INDUSTRIES (JULPHAR)-AIRPORT ROAD,
DIGDAGA STREET
RAS AL KHAIMAH
UNITED ARAB EMIRATESTOPICAL EXTERNAL OINTMENTS1.0X30.0 G TUBE24/10/2017
101NDA/MAL/HHP/8457BHARGAVA PHYTOLAB PVT. LTDPLANET PHARMACEUTICALS UGANDA LTDGASTICA SYRUPBHARGAVA PHYTOLAB PVT.LTD-E-1216 PHASE-1, EXTN. GHATAL,BHIWADI INDUSTRIAL AREA, BHIWADI(RAJ.) INDIA INDIAORAL LIQUID ORDINARY SYRUPS1.0X200.0 ML BOTTLE01/07/2017
102NDA/MAL/HHP/8505CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDLIVOMYN SYRUP CHARAK PHARMA PVT LTD-INDUSTRIALESTATE, SHAUTI MILL LANE, MUMBAI-400011 INDIAORAL LIQUID ORDINARY LIQUIDS1.0X200.0 ML BOTTLE02/02/2018
103NDA/MAL/HHP/8506CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDALKA 5 SYRUP CHARAK PHARMA PVT LTD-INDUSTRIALESTATE, SHAUTI MILL LANE, MUMBAI-400011 INDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE02/02/2018
104NDA/MAL/HHP/8507SYDLER REMEDIES PVT LTD M-190ROYAL PHARMA 2011 LIMITEDCUFSOL LOZENGES ORANGESYDLER REMEDIES PVT LTD-M-190 MIDC WALUJ AURANGABAD 431136INDIAORAL SOLID ORDINARY LOZENGES1.0X2.0X50.0 LOZENGE BLISTER02/02/2018
105NDA/MAL/HHP/8508CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDKOFOL SF SYRUP CHARAK PHARMA PVT LTD-INDUSTRIALESTATE, SHAUTI MILL LANE, MUMBAI-400011 INDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE02/02/2018
106NDA/MAL/HHP/8509CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDEVANOVA CAPSULE CHARAK PHARMA PVT LTD-INDUSTRIALESTATE, SHAUTI MILL LANE, MUMBAI-400011 INDIAORAL SOLID ORDINARY CAPSULES1.0X20.0 CAPSULE BLISTER29/11/2017
107NDA/MAL/HHP/8510BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDFRICKS COUGH SYRUPBLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIAINDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE06/03/2018
108NDA/MAL/HHP/8511BHARGAVA PHYTOLAB PVT. LTDPLANET PHARMACEUTICALS UGANDA LTDTHUNDER-MBHARGAVA PHYTOLAB PVT. LTD -E-1216, PHASE – 1, EXTN. GHATAL, BHIWADI INDUSTRIAL AREA, BHIWADI (RAJ.) INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2017
109NDA/MAL/HHP/8512BHARGAVA PHYTOLAB PVT. LTDPLANET PHARMACEUTICALS UGANDA LTDINFAB SYRUPBHARGAVA PHYTOLAB PVT. LTD -E-1216, PHASE – 1, EXTN. GHATAL, BHIWADI INDUSTRIAL AREA, BHIWADI (RAJ.) INDIA INDIAORAL LIQUID ORDINARY SYRUPS1.0X120.0 ML BOTTLE01/07/2017
110NDA/MAL/HHP/8513BHARGAVA PHYTOLAB PVT. LTDPLANET PHARMACEUTICALS UGANDA LTDMENIPHIBBHARGAVA PHYTOLAB PVT. LTD -E-1216, PHASE – 1, EXTN. GHATAL, BHIWADI INDUSTRIAL AREA, BHIWADI (RAJ.) INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X20.0 TABLET BLISTER01/07/2016
111NDA/MAL/HHP/8548ARTURA PHARMACEUTICALS PVT LTDMEDVIN PHARMA LIMITEDPEPSOLARTURA PHARMACEUTICALS PVT LTD-PLOT NO. 1505 PORTIA ROAD SIRI CITY SEZ SATYAVEDU MANDAL CHITTOOR DISTRICT ANDHRA PRADESHI - 517 588 INDIAINDIAORAL SOLID ORDINARY OTHER CAPSULES1.0X3.0X10.0 CAPSULE BLISTER24/10/2017
112NDA/MAL/HHP/8549UNOSOURCE PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDUNOSOYMAXCURE NUTRVEDIC LTD-PLOT NO. 13, SECTOR 6-A,INTEGRATED INDUSTRIAL ESTATE(IIE), SIDCUL
HARIDWAR-249403 UTTARAKHAND
INDIAORAL SOLID ORDINARY OTHER CAPSULES1.0X60.0 CAPSULE BOTTLE24/10/2017
113NDA/MAL/HHP/8550UNOSOURCE PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDUNOCALMMAXCURE NUTRVEDIC LTD-PLOT NO. 13, SECTOR 6-A,INTEGRATED INDUSTRIAL ESTATE(IIE), SIDCUL
HARIDWAR-249403 UTTARAKHAND
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X60.0 TABLET BOTTLE24/10/2017
114NDA/MAL/HHP/8551AMRUTANJAN HEALTHCARE LIMITEABACUS PHARMA (AFRICA) LIMITEDAMRUTANJAN RELIEF COUGH AND COLD SYRUPAMRUTANJAN HEALTH CARE LIMITED -PLOT NO.14, INDUSTRIAL DEVELOPMENT AREA, UPPAL HYDERABAD - 500039, INDIA
PLOT NO.:37, 38 & 39, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR VILLAGE, THIRUPORUR TK,
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INDIAORAL LIQUID ORDINARY UNIT DOSE LIQUIDS1.0X8.0 ML SACHET24/11/2017
115NDA/MAL/HHP/8552AMRUTANJAN HEALTHCARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDAMRUTANJAN DRAGON BALMAMRUTANJAN HEALTH CARE LIMITED -PLOT NO.14, INDUSTRIAL DEVELOPMENT AREA, UPPAL HYDERABAD - 500039, INDIA
PLOT NO.:37, 38 & 39, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR VILLAGE, THIRUPORUR TK,
KANCHEEPURAM, DIST. – 603 110, TAMILNADU, INDIA
INDIATOPICAL EXTERNAL GELS AND SOLS1.0X10.0 G CONTAINER24/11/2017
116NDA/MAL/HHP/8553RAZA INTERNATIONALWIDE SPECTRUM ENTERPRISES (U) LIMITEDHONEY CUREOZONE COSMETICS & NATURAL PRODUCTS MANUFACTURING COMPANY?-SHARA BADRAN, MARJ ALFARAS, INDUSTRIAL ZONE, MUSAWAA STREET.
OZONE INDUSTRIAL COMPLEX. P.O. BOX : 1764. AMMAN 11953, JORDAN
JORDANTOPICAL EXTERNAL OINTMENTS1.0X30.0 G TUBE,1.0X15.0 G TUBE13/07/2017
117NDA/MAL/HHP/8554OVIANI PHARMACHEM PVT. LTDMUKWANO PHARMACEUTICALS LIMITEDDIGLOCISHA AGRO DEVELOPERS PVT.LTD-36A/55AB, LONAVALA CO.OP.INDL.EST.LTD,
VILLAGE-NANGARGAON, LONAVALA,TALUKA-MAVAL,DIST. PUNE 410401 MAHARASHTRA INDIA
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X60.0 TABLET BOTTLE21/11/2017
118NDA/MAL/HHP/8555MUSANA PHARMACEUTICALS LIMITEDMUSANA PHARMACEUTICALS LTDNATURAL AIDNIXON BIOTECH PRIVATE LIMITED-PLOT NO. 861 INDUSTRIAL AREA-4 LUDHIANA-3(PUNJAB) INDIAINDIAORAL SOLID ORDINARY OTHER CAPSULES1.0X30.0 CAPSULE BOTTLE13/11/2017
119NDA/MAL/HHP/8556MANKIND PHARMA LTD.TATA UGANDA LIMITEDUNIORTHO-500TIRUPATI LIFESCIENCES-NAHAN ROAD, PAONTA SAHIB, DISTT. SIRMOUR HIMACHAL PRADESH-173025, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER10/11/2017
120NDA/MAL/HHP/8557MANKIND PHARMA LTD.TATA UGANDA LIMITEDUNIORTHO-250TIRUPATI LIFESCIENCES-NAHAN ROAD, PAONTA SAHIB, DISTT. SIRMOUR HIMACHAL PRADESH-173025, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER10/11/2017
121NDA/MAL/HHP/8672OVIANI PHARMACHEM PVT. LTDMUKWANO PHARMACEUTICALS LIMITEDHYARTHO CAPSULESISHA AGRO DEVELOPERS PVT.LTD-36A/55AB, LONAVALA CO.OP.INDL.EST.LTD,
VILLAGE-NANGARGAON, LONAVALA,TALUKA-MAVAL,DIST. PUNE 410401 MAHARASHTRA INDIA
INDIAORAL SOLID ORDINARY OTHER CAPSULES1.0X60.0 CAPSULE BOTTLE28/03/2018
122NDA/MAL/HHP/8673OVIANI PHARMACHEM PVT. LTDMUKWANO PHARMACEUTICALS LIMITEDCALMLA CAPSULEISHA AGRO DEVELOPERS PVT.LTD-36A/55AB, LONAVALA CO.OP.INDL.EST.LTD,
VILLAGE-NANGARGAON, LONAVALA,TALUKA-MAVAL,DIST. PUNE 410401 MAHARASHTRA INDIA
INDIAORAL SOLID ORDINARY OTHER CAPSULES1.0X60.0 CAPSULE BOTTLE28/03/2018
123NDA/MAL/HHP/8674OVIANI PHARMACHEM PVT. LTDMUKWANO PHARMACEUTICALS LIMITEDPYLKER TABLETSISHA AGRO DEVELOPERS PVT.LTD-36A/55AB, LONAVALA CO.OP.INDL.EST.LTD,
VILLAGE-NANGARGAON, LONAVALA,TALUKA-MAVAL,DIST. PUNE 410401 MAHARASHTRA INDIA
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X60.0 TABLET BOTTLE27/03/2018
124NDA/MAL/HHP/8675OVIANI PHARMACHEM PVT. LTDMUKWANO PHARMACEUTICALS LIMITEDDIBCARE TABLETSISHA AGRO DEVELOPERS PVT.LTD-36A/55AB, LONAVALA CO.OP.INDL.EST.LTD,
VILLAGE-NANGARGAON, LONAVALA,TALUKA-MAVAL,DIST. PUNE 410401 MAHARASHTRA INDIA
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X60.0 TABLET BOTTLE28/03/2018
125NDA/MAL/HHP/8676OVIANI PHARMACHEM PVT. LTDMUKWANO PHARMACEUTICALS LIMITEDSUTRIM TABLETSISHA AGRO DEVELOPERS PVT.LTD-36A/55AB, LONAVALA CO.OP.INDL.EST.LTD,
VILLAGE-NANGARGAON, LONAVALA,TALUKA-MAVAL,DIST. PUNE 410401 MAHARASHTRA INDIA
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X60.0 TABLET BOTTLE27/03/2018
126NDA/MAL/HHP/8837PILLAR PHARMA LIMITEDPILLAR LOGISTICS LIMITEDHEPTOVITMILENNIUM HERBAL CARE LTD-12B, NIRMAL, 241/242, BACKBAY RECLAMATION, NARIMAN POINT, MUMBAI 400 021 INDIAORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER07/06/2018
127NDA/MAL/HHP/8840UNOSOURCE PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDOBECONMAXCURE NUTRVEDIC LTD-PLOT NO. 13, SECTOR 6-A,INTEGRATED INDUSTRIAL ESTATE(IIE), SIDCUL
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INDIAORAL SOLID ORDINARY CAPSULES1.0X60.0 CAPSULE BOTTLE01/07/2018
128NDA/MAL/HHP/8892NANO BIOPHARMA LIMITEDUNEED GLOBAL GROUP LIMITEDANGIPARSNANO HAYAT DAROU (NANO BIOPHARMA)-NO.168/2 16TH NOAVARI STREET, PARDIS TECHNOLOGY PARK-PARDIS-TEHRAN-IRAN IRANTOPICAL EXTERNAL OINTMENTS1.0X30.0 G TUBE28/06/2018
129NDA/MAL/HHP/8893NANO BIOPHARMA LIMITEDUNEED GLOBAL GROUP LIMITEDANGIPARSNANO HAYAT DAROU (NANO BIOPHARMA)-NO.168/2 16TH NOAVARI STREET, PARDIS TECHNOLOGY PARK-PARDIS-TEHRAN-IRAN IRANORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER28/06/2018
130NDA/MAL/HHP/8899LEXINE TECHNOCHEM PVT LTDMUKWANO PHARMACEUTICALS LIMITEDLEXICOF HERBAL COUGH SYRUPLEXINE TECHNOCHEM PVT LTD -SURVEY PLOT NO. 373,
OPP. RAMAKAKA DERI CHHANI, VADODARA – 391704 GUJARAT, INDIA
INDIAORAL LIQUID ORDINARY SYRUPS1.0X1.0X100.0 ML BOTTLE14/03/2018
131NDA/MAL/HHP/8900UNOSOURCE PHARMA LTD.ABACUS PHARMA (AFRICA) LIMITEDMIGROSTOPUNOSOURCE PHARMA LTD -503/504, HUBTOWN SOLARIS, N.S PHADKE MARG, ANDHERRI EAST, MUMAI 400069 INDIA INDIAORAL SOLID ORDINARY OTHER CAPSULES1.0X60.0 CAPSULE CONTAINER20/07/2018
132NDA/MAL/HHP/8901WILSHIRE LABORATORIES (PVT) LTDHEALTHCARE LTD.DE-TUZ LOZENGESWILSHIRE LABORATORIES (PVT) LTD-124/1 INDUSTRIAL AREA, KOT LAKHPAT LAHORE PAKISTAN PAKISTANORAL SOLID ORDINARY LOZENGES1.0X3.0X10.0 LOZENGE BLISTER28/06/2018
133NDA/MAL/HHP/8902WILSHIRE LABORATORIES (PVT) LTDHEALTHCARE LTD.DE-TUZ SYRUPWILSHIRE LABORATORIES (PVT) LTD-124/1 INDUSTRIAL AREA, KOT LAKHPAT LAHORE PAKISTAN PAKISTANORAL LIQUID ORDINARY SYRUPS1.0X120.0 ML BOTTLE28/06/2018
134NDA/MAL/HHP/8979LEXINE TECHNOCHEM PVT LTDMUKWANO PHARMACEUTICALS LIMITEDKWIK PAIN BALMLEXINE TECHNOCHEM PVT LTD -SURVEY PLOT NO. 373,
OPP. RAMAKAKA DERI CHHANI, VADODARA – 391704 GUJARAT, INDIA
INDIATOPICAL EXTERNAL OINTMENTS1.0X10.0 G TUBE,1.0X22.0 G TUBE14/03/2018
135NDA/MAL/HHP/9026LEXINE TECHNOCHEM PVT LTDMUKWANO PHARMACEUTICALS LIMITEDBABY CARE + GRIPE WATER 130MLLEXINE TECHNOCHEM PVT LTD -SURVEY PLOT NO. 373,
OPP. RAMAKAKA DERI CHHANI, VADODARA – 391704 GUJARAT, INDIA
INDIAORAL LIQUID ORDINARY LIQUIDS1.0X130.0 ML BOTTLE01/07/2015
136NDA/MAL/HHP/9085BRAWN COSMETICS & HERBALS PVT LTDMEDVIN PHARMA LIMITEDACH..OO 2 IN 1BRAWN COSMETICS & HERBALS PVT LTD-PLOT NO-30, SECTOR –33, NEAR INFOCITY,GURGAON II–122001,HARYANA,INDIA INDIATOPICAL EXTERNAL TABLETS1.0X2.0X6.0 ML ROD07/11/2018
137NDA/MAL/HHP/9086DR. KIM AYURVEDIC PHARMACYJ.P.IMPEX PHARMACY (U) LIMITEDSMOOTH C-COOL COUGH TABLETSDR KIM AYURVEDIC PHARMACY-SHED NO. 139, ADARSH ESTATE, NEAR CHAKUDIA TEMPLE, RAKHIAL AHMEDABAD GUJARAT - INDIA INDIAORAL SOLID ORDINARY LOZENGES1.0X100.0 LOZENGE CARTON07/11/2018
138NDA/MAL/HHP/9087HIMONT LABORATORIES PVT LTDBOOTS PHARMACEUTICALS LIMITEDEPITIZEHIMONT LABORATORIES PVT LIMITED-17-KM FEROZEPUR ROAD LAHORE
PAKISTAN
PAKISTANORAL LIQUID ORDINARY SYRUPS1.0X120.0 ML BOTTLE01/07/2015
139NDA/MAL/HHP/9088HIMOT LABORATORIES PVT LIMITEDBOOTS PHARMACEUTICALS LIMITEDPASMOLEX DROPSHIMOT LABORATORIES PVT LTD-17KM FEROZEPUR ROAD LAHORE PAKISTANPAKISTANORAL LIQUID ORDINARY DROPS1.0X120.0 ML BOTTLE01/07/2015
140NDA/MAL/HHP/9090I_CARE PHARMA LIMITEDAIVEEN (U) LIMITEDFATNILEWEST COAST PHARMACEUTICAL WORKS LTD-1143,MELDI ESTATE,NR PRASANG PARTY PLOT,GOTA, AHMEDEBAD INDIAORAL SOLID ORDINARY OTHER CAPSULES1.0X4.0X15.0 CAPSULE BLISTER28/01/2019
141NDA/MAL/HHP/9091UNOSOURCE PHARMA LTDESCORTS PHARMACEUTICALS LIMITEDKOFCLEAN SYRUP (HERBAL COUGH SYRUP)MAXCURE NUTRAVEDICS LTD -PLOT NO.13 SEC-6A IIE,SIDCUL,RANIPUR,HARIDWAR-249 403, UTTRAKHAND INDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE28/01/2019
142NDA/MAL/HHP/9092SYDLER REMEDIES PVT LTDABACUS PHARMA (AFRICA) LIMITEDEAZOL HERBAL COUGH LOZENGES (HERBAL FLAVOUR)SYDLER REMEDIES-PRIM-190, MIDC, WALUJ, AURANGABAD-431136, MAHARASHTRA, INDIA INDIAORAL SOLID ORDINARY LOZENGES1.0X5.0X4.0 LOZENGE STRIP22/03/2019
143NDA/MAL/HHP/9093BETA HEALTHCARE UGANDA LIMITEDBETA HEALTHCARE UGANDA LIMITEDCOFTA EXTRA SYRUPBETA HEALTHCARE INTERNATIONAL LTD -PLOT NO LR 209/6534 MOGADISHU ROADKENYAORAL LIQUID ORDINARY LIQUIDS1.0X100.0 ML BOTTLE22/03/2019
144NDA/MAL/HHP/9094BETA HEALTHCARE UGANDA LIMITEDBETA HEALTHCARE UGANDA LIMITEDBETASIL HERBAL COUGH SYSRUPBETA HEALTHCARE INTERNATIONAL LTD -PLOT NO LR 209/6534 MOGADISHU ROADKENYAORAL LIQUID ORDINARY LIQUIDS1.0X100.0 ML BOTTLE22/03/2019
145NDA/MAL/HHP/9095WILSHIRE LABORATORIES (PVT) LTDHEALTHCARE LTD.X-TREMEWILSHIRE LABORATORIES (PVT) LTD-124/1 INDUSTRIAL AREA, KOT LAKHPAT LAHORE PAKISTAN PAKISTANORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER23/04/2019
146NDA/MAL/HHP/9096HIMONT LABORATORIES PVT LTDBOOTS PHARMACEUTICALS LIMITEDCOFCIDHIMONT LABORATORIES (PVT) LTD-17KM FEROZEPUR ROAD LAHORE PAKISTANPAKISTANORAL LIQUID ORDINARY SYRUPS1.0X120.0 ML BOTTLE24/05/2019
147NDA/MAL/HHP/9097HIMONT LABORATORIES PVT LTDBOOTS PHARMACEUTICALS LIMITEDFLUCIDHIMONT LABORATORIES (PVT) LTD-17KM FEROZEPUR ROAD LAHORE PAKISTANPAKISTANORAL LIQUID ORDINARY SYRUPS1.0X120.0 ML BOTTLE24/05/2019
148NDA/MAL/HHP/9098HIMONT LABORATORIES PVT LTDBOOTS PHARMACEUTICALS LIMITEDCARIPEPTIC SYRUPHIMONT LABORATORIES (PVT) LTD-17KM FEROZEPUR ROAD LAHORE PAKISTANPAKISTANORAL LIQUID ORDINARY SYRUPS1.0X120.0 ML BOTTLE31/05/2019
149NDA/MAL/HHP/9099HINUCONBOOTS PHARMACEUTICALS LIMITEDCRAN MAX PRO SACHETHINUCON -PLOT NO.12/1 SECTOR 15,KORANGI INDUSTRIAL AREA, KARACHI 9TH FLOOR PROGRESSIVE PLAZA,BEAUMONT ROAD,KARACHI,PAKISTAN PAKISTANORAL LIQUID ORDINARY SOLUBLE POWDERS1.0X10.0 SACHET CARTON31/05/2019
150NDA/MAL/HHP/9100HINUCONBOOTS PHARMACEUTICALS LIMITEDFIBO SACHETHINUCON -PLOT NO.12/1 SECTOR 15,KORANGI INDUSTRIAL AREA, KARACHI 9TH FLOOR PROGRESSIVE PLAZA,BEAUMONT ROAD,KARACHI,PAKISTAN PAKISTANORAL LIQUID ORDINARY SOLUBLE POWDERS1.0X10.0 SACHET CARTON31/05/2019
151NDA/MAL/HHP/9101HINUCONBOOTS PHARMACEUTICALS LIMITEDFIBO SYRUPHINUCON -PLOT NO.12/1 SECTOR 15,KORANGI INDUSTRIAL AREA, KARACHI 9TH FLOOR PROGRESSIVE PLAZA,BEAUMONT ROAD,KARACHI,PAKISTAN PAKISTANORAL LIQUID ORDINARY SYRUPS1.0X120.0 ML BOTTLE31/05/2019
152NDA/MAL/HHP/9102HINUCONBOOTS PHARMACEUTICALS LIMITEDEPTI SYRUPHINUCON -PLOT NO.12/1 SECTOR 15,KORANGI INDUSTRIAL AREA, KARACHI 9TH FLOOR PROGRESSIVE PLAZA,BEAUMONT ROAD,KARACHI,PAKISTAN PAKISTANORAL LIQUID ORDINARY SYRUPS1.0X120.0 ML BOTTLE31/05/2019
153NDA/MAL/HHP/9103HINUCONBOOTS PHARMACEUTICALS LIMITEDHILGAS SYRUPHINUCON -PLOT NO.12/1 SECTOR 15,KORANGI INDUSTRIAL AREA, KARACHI 9TH FLOOR PROGRESSIVE PLAZA,BEAUMONT ROAD,KARACHI,PAKISTAN PAKISTANORAL LIQUID ORDINARY SYRUPS1.0X120.0 ML BOTTLE31/05/2019
154NDA/MAL/HHP/9104HINUCONBOOTS PHARMACEUTICALS LIMITEDCOLOREST DROPSHINUCON -PLOT NO.12/1 SECTOR 15,KORANGI INDUSTRIAL AREA, KARACHI 9TH FLOOR PROGRESSIVE PLAZA,BEAUMONT ROAD,KARACHI,PAKISTAN PAKISTANORAL LIQUID ORDINARY DROPS1.0X30.0 ML BOTTLE31/05/2019
155NDA/MAL/HHP/9105HINUCONBOOTS PHARMACEUTICALS LIMITEDRIMONA CAPSULESHINUCON -PLOT NO.12/1 SECTOR 15,KORANGI INDUSTRIAL AREA, KARACHI 9TH FLOOR PROGRESSIVE PLAZA,BEAUMONT ROAD,KARACHI,PAKISTAN PAKISTANORAL SOLID ORDINARY CAPSULES1.0X2.0X10.0 CAPSULE BLISTER31/05/2019
156NDA/MAL/HHP/9106BHARGAVA PHYTOLAB PVT. LTDFARHAN LIMITEDPILORALBHARGAVA PHYTOLAB PVT.LTD-E-1216 PHASE-1, EXTN. GHATAL,BHIWADI INDUSTRIAL AREA, BHIWADI(RAJ.) INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X2.0X15.0 TABLET BLISTER13/06/2019
157NDA/MAL/HHP/9107BHARGAVA PHYTOLAB PVT. LTDFARHAN LIMITEDHEPATINA TABLETSBHARGAVA PHYTOLAB PVT.LTD-E-1216 PHASE-1, EXTN. GHATAL,BHIWADI INDUSTRIAL AREA, BHIWADI(RAJ.) INDIA INDIAORAL SOLID ORDINARY TABLETS1X2X15 TABLET BLISTER13/06/2019
158NDA/MAL/HHP/9108BHARGAVA PHYTOLAB PVT. LTDFARHAN LIMITEDARTHARAL TABLETBHARGAVA PHYTOLAB PVT.LTD-E-1216 PHASE-1, EXTN. GHATAL,BHIWADI INDUSTRIAL AREA, BHIWADI(RAJ.) INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER13/06/2019
159NDA/MAL/HHP/9115NZEN ENTERPRISEHEALTHCARE LTD.DO-MO CAPSULES ABARIS HEALTHCARE PVT. LTD-SURVEY NO. 1407/11, VILLAGE RAJPUR, TAL KADI DIST. MEHSANA, GUJARAT-382740 INDIAORAL SOLID ORDINARY CAPSULES1.0X4.0X10.0 CAPSULE BLISTER16/07/2019
NDA REGISTRATION NUMBERLICENSE HOLDERLOCAL TECHNICAL REPRESENTATIVENAME OF DRUGMANUFACTURERCOUNTRY OF MANUFACTUREDOSAGE FORMPACK SIZE
NDA/MAL/VHP/8117COOPER K-BRANDS LTDCEE K-BRANDS LIMITEDSOOTHING OILCOOPER K. BRANDS LTD -P.O. BOX 40596 00100 NAIROBI,KENYA. ON KAPTAGAT ROAD, OFF WAIYAKI WAY,
NAIROBI
KENYAOILS1.0X100.0 ML BOTTLE,1.0X250.0 ML BOTTLE
S/NNDA REGISTRATION NUMBERLICENSE HOLDERLOCAL TECHNICAL REPRESENTATIVENAME OF DRUGGENERIC NAME OF DRUGSTRENGTH OF DRUGMANUFACTURERCOUNTRY OF MANUFACTUREDOSAGE FORMPACK SIZEREGISTRATION DATE
1NDA/MAL/HDP/0001INGELHEIM PHARMACEUTICAL LTDSURGIPHARM (U) LIMITEDMICARDIS 40TELMISARTAN40MGBOEHRINGER INGELHEIM PHARMA GMBH & CO. KG.,-BIRKENDORFER STRASSE 65, 88397, BIBERACH AN DER RISS GERMANYORAL SOLID ORDINARY TABLETS1.0X4.0X7.0 TABLET BLISTER01/07/1997
2NDA/MAL/HDP/0002PHARMACIE BETHELABACUS PARENTERAL DRUGS LIMITEDX-SONE-NDEXAMETHASONE+NEOMYCIN0.1W/V+ 0.35W/VABACUS PARENTERAL DRUGS LTD.-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE,
MUKONO
UGANDAOPHTHALMIC DROPS1.0X10.0 ML VIAL01/07/2011
3NDA/MAL/HDP/0003UNI MEDICO LABSHREEJI PHARMACEUTICALS LIMITEDUMOXIL CLAV 625AMOXICILLIN + CLAVULANATE POTASSIUM500 MG + 125 MGUNI MEDICOLABS-21-22 PHARMACITY SELAQUI DEHRADUN 248197INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X7.0 TABLET BLISTER01/07/2015
4NDA/MAL/HDP/0005STALLION LABORATORIES PVT LTDSHREEJI PHARMACEUTICALS LIMITEDALPRAZEC 0.25ALPRAZOLAM0.25MGACME FORMULATION PVT LTD -ROPAR ROAD NALAGARH DIST SOLAN HIMACHAL PRADESHINDIAORAL SOLID ORDINARY COATED TABLETS1.0X4.0X10.0 TABLET BLISTER01/07/2014
5NDA/MAL/HDP/0006HOVID BHDUNITED HEALTHCARE DISTRIBUTORS LTDDIAMIDEGLIBENCLAMIDE + METFORMIN HYDROCHLORIDE5MG + 500MGHOVID BHD (IPOH SITE)-121 ,JALAN TUNKU ABDUL RAHMAN , 30010 IPOH , PERAK , MALAYSIA MALAYSIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X12.0 TABLET BLISTER01/07/2014
6NDA/MAL/HDP/0007AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDPROCIP SYRUPCYPROHEPTADINE HYDROCHLORIDE2MG/5MLAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE01/07/2013
7NDA/MAL/HDP/0008STALLION LABORATORIES PVT LTDSHREEJI PHARMACEUTICALS LIMITEDOMEPRICOMEPRAZOLE DELAYED-RELEASE20MGACME FORMULATION PVT LTD.-ROPAR ROAD NALAGARH DIST SOLAN HIMACHAL PRADESHINDIAORAL SOLID RETARD CAPSULES1.0X10.0X10.0 CAPSULE BLISTER01/07/2014
8NDA/MAL/HDP/0009STALLION LABORATORIES PVT LTDSHREEJI PHARMACEUTICALS LIMITEDDINASOD-100DICLOFENAC100MGACME FORMULATION PVT LTD,-ACME FORMULATION PVT LTD ROPAR ROAD NALAGARH DIST SOLAN HIMACHAL PRADESH INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2014
9NDA/MAL/HDP/0010STALLION LABORATORIES PVT LTDSHREEJI PHARMACEUTICALS LIMITED02-LONOFLOXACIN + ORNIDAZOLE200MG + 500MGACME FORMULATION PVT LTD.-ROPAR ROAD, NALAGARH, DIST. SOLAN, HIMACHAL PRADESH 174101 INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2014
10NDA/MAL/HDP/0011INGELHEIM PHARMACEUTICAL LTDSURGIPHARM (U) LIMITEDMICARDIS 80TELMISARTAN80MGBOEHRINGER INGELHEIM PHARMA GMBH & CO. KG.,-BIRKENDORFER STRASSE 65, 88397, BIBERACH AN DER RISS GERMANYORAL SOLID ORDINARY TABLETS1.0X4.0X7.0 TABLET BLISTER01/07/2015
11NDA/MAL/HDP/0012HOVID BHDUNITED HEALTHCARE DISTRIBUTORS LTDPENGESIC SRTRAMADOL HYDROCHLORIDE SR100MGHOVID BHD-LOT 56442, 7.5 MILE JALAN IPOH/CHEMO 31200 CHEMOR, PERAK MALAYSIA MALAYSIAORAL SOLID RETARD TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2013
12NDA/MAL/HDP/0014PLOUGHUNITED HEALTHCARE DISTRIBUTORS LTDMONTELAIR 10MG TABLETMONTELUKAST10MGHOVID BHD (IPOH SITE)-121 ,JALAN TUNKU ABDUL RAHMAN , 30010 IPOH , PERAK , MALAYSIA MALAYSIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2014
13NDA/MAL/HDP/0016REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDCODIMEX-CT TABLETSCETIRIZINE DIHYDROCHLORIDE10MGREGAL PHARMACEUTICALS LIMITED -PLOT 7879/18 OF BABA DOGO ROAD, RUARAKA, NAIROBI KENYAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X10.0 TABLET BLISTER01/07/2014
14NDA/MAL/HDP/0017SWISS PARENTERALS PVT LTDSHREEJI PHARMACEUTICALS LIMITEDHYCORTHYDROCORTISONE100MGSWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIAINDIAPARENTERAL ORDINARY DRY VIALS1.0X10.0X7.5 ML VIAL01/07/2011
15NDA/MAL/HDP/0018INGELHEIM PHARMACEUTICAL LTDSURGIPHARM (U) LIMITEDCO-MICARDISTELMISARTAN + HYDROCHLOROTHIAZIDE40MG + 12.5MGBOEHRINGER INGELHEIM PHARMA GMBH & CO. KG.,-BIRKENDORFER STRASSE 65, 88397, BIBERACH AN DER RISS GERMANYORAL SOLID ORDINARY TABLETS1.0X4.0X7.0 TABLET BLISTER01/07/1997
16NDA/MAL/HDP/0021SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDQUINSQUININE DIHYDROCHLORIDE300MG/MLSAKAR HEALTHCARE PVT. LTD-PLOT 10/13 SAKHEJ-BAVLA ROAD, AHMEDABAD,GUJURAT,INDIA INDIAPARENTERAL ORDINARY AMPOULES1.0X100.0X2.0 ML AMPOULE,1.0X2.0X5.0X2.0 ML AMPOULE01/07/2013
17NDA/MAL/HDP/0022AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDQUININE SULPHATEQUININE SULPHATE300MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER01/07/2009
18NDA/MAL/HDP/0024KOPRAN LIMITEDTATA UGANDA LIMITEDAMPICLOXAAMPICILLIN + CLOXACILLIN250 MG + 250 MGKOPRAN LIMITED-VILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIA INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER01/07/1997
19NDA/MAL/HDP/0025ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDAMLOAS-5AMLODIPINE5MGASTRA LIFE CARE (INDIA) PVT.LTD-PLOT 57/P, SARKHEJ-BAVLA HIGHWAY, RAJODA 382 220,TALUKA BAVLA DIST AHMEDABAD, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2013
20NDA/MAL/HDP/0026ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDAMLOAS-10AMLODIPINE10MGASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2015
21NDA/MAL/HDP/0028ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDHYPERLOK-50ATENOLOL50MGASTRA LIFECARE (INDIA) PVT. LTD-PLOT 57/P, SARKHEJ-BAVLA HIGHWAY, RAJODA 382 220, AHMEDABAD, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2013
22NDA/MAL/HDP/0029ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDHYPERLOK-100ATENOLOL100MGASTRA LIFECARE (INDIA) PVT. LTD-PLOT 57/P, SARKHEJ-BAVLA HIGHWAY, RAJODA 382 220, AHMEDABAD, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2013
23NDA/MAL/HDP/0030UNOSOURCE PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDTRADMINTRAMADOL HYDROCHLORIDE50MG/MLAKUMS DRUGS & PHARMACEUTICALS LTD. -PLANT III,-PLOT NO. 2, 3, 4 & 5, SECTOR 6-B, IIE, SIDCUL,RANIPUR, 249 403
INDIAPARENTERAL ORDINARY AMPOULES1.0X5.0X2.0 ML AMPOULE01/07/2015
24NDA/MAL/HDP/0031MANKIND PHARM LTDTATA UGANDA LIMITEDCEFTATIME-SB 1.5CEFTRIAXONE+SULBACTAM1000MG+500MGMANKIND PHARMA LTD--VILLAGE KISHANPURA P.O JAMNI WALA TEHSIL PAONTA SAHIB DISTT SIRMOUR 173025 HIMACHAL PRADESHINDIAPARENTERAL ORDINARY DRY VIALS1.0X1.5 G VIAL01/07/2015
25NDA/MAL/HDP/0032INGELHEIM PHARMACEUTICAL LTDSURGIPHARM (U) LIMITEDCO-MICARDISTELMISARTAN + HYDROCHLOROTHIZIDE80MG + 12.5MGBOEHRINGER INGELHEIM PHARMA GMBH & CO. KG.,-BIRKENDORFER STRASSE 65, 88397, BIBERACH AN DER RISS GERMANYORAL SOLID ORDINARY TABLETS1.0X4.0X7.0 TABLET BLISTER01/07/2013
26NDA/MAL/HDP/0033ELYS CHEMICAL INDUSTRIES LTDVELVET PHARMA LIMITEDELYVATE CREAMBETAMETHASONE VALERATE0.1%W/WELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBI KENYATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE01/07/1997
27NDA/MAL/HDP/0037MIRACALUS PHARMA PVT.LTDAIVEEN (U) LIMITEDL-ASPASEL-ASPARGINASE 1000 I.UNAPROD LIFE SCIENCE PVT LTD-PLOT G-17/1 MIDC TARAPUR BOISAR, DIST. THANE-401506
MAHARASTRA, INDIA.
INDIAPARENTERAL ORDINARY I M VIALS1.0X10.0 ML VIAL01/07/2013
28NDA/MAL/HDP/0038MIRACALUS PHARMA PVT.LTDAIVEEN (U) LIMITEDARZI 200DACARBAZINE200MGNAPROD LIFE SCIENCE PVT LTD-PLOT G-17/1 MIDC TARAPUR BOISAR, DIST. THANE-401506
MAHARASTRA, INDIA.
INDIAPARENTERAL ORDINARY VIALS1.0X20.0 ML VIAL01/07/2013
29NDA/MAL/HDP/0039MIRACALUS PHARMA PVT.LTDAIVEEN (U) LIMITEDNZYTOPETOPOSIDE INJECTION USP100MGNAPROD LIFE SCIENCE PVT LTD-PLOT G-17/1 MIDC TARAPUR BOISAR, DIST. THANE-401506
MAHARASTRA, INDIA.
INDIAPARENTERAL ORDINARY VIALS1.0X5.0 ML VIAL01/07/2013
30NDA/MAL/HDP/0041RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDRECIMCIMETIDINE200MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA UGANDAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2013
31NDA/MAL/HDP/0042MIRACALUS PHARMA PVT.LTDAIVEEN (U) LIMITEDCISPLATINCISPLATIN1MG/MLNAPROD LIFE SCIENCE PVT LTD-PLOT G-17/1 MIDC TARAPUR BOISAR, DIST. THANE-401506
MAHARASTRA, INDIA.
INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X50.0 ML VIAL01/07/2012
32NDA/MAL/HDP/0043KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMADOL JUNIORPARACETAMOL250MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALAUGANDAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2013
33NDA/MAL/HDP/0044MIRACALUS PHARMA PVT.LTDAIVEEN (U) LIMITEDNAPRO-TAXPACLITAXEL6MG/MLNAPROD LIFE SCIENCE PVT LTD-PLOT G-17/1 MIDC TARAPUR BOISAR, DIST. THANE-401506
MAHARASTRA, INDIA.
INDIAPARENTERAL ORDINARY OTHER VIALS1.0X1.0X20.0 ML VIAL01/07/2012
34NDA/MAL/HDP/0045AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOMOLPARACETAMOL500MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER01/07/2007
35NDA/MAL/HDP/0046MIRACALUS PHARMA PVT.LTDAIVEEN (U) LIMITEDABINGEMGEMCITABINE1GNAPROD LIFE SCIENCES PVT LTD-G-17, MIDC, TARAPUR INDUSTRIAL AREA, BIOSAR THANE, MUMBAI INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0 G VIAL01/07/2012
36NDA/MAL/HDP/0047MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDLAMIHOPE ETEFAVIRENZ + LAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE600MG + 300MG + 300MGMACLEODS PHARMACEUTICALS LIMITED (BLOCK –N1)-VILLAGE THEDA, P.O. LODHI MAJRA,TEHSIL BADDI, HIMACHAL PRADESH -174101,INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X30.0 TABLET BOTTLE01/07/2015
37NDA/MAL/HDP/0051H. LUNDBECK A/SPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDCLOPIXOL ACUPHASE ZUCLOPENTHIXOL ACETATE50MG/MLH. LUNDBECK A/S - OTTILIAVEJ 9,2500 VALBY DENMARKPARENTERAL ORDINARY AMPOULES1.0X1.0 ML AMPOULE01/07/2015
38NDA/MAL/HDP/0052MEDICAL UNION PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.DISPERCAMPIROXICAM0.5%W/VMEDICAL UNION PHARMACEUTICALS CO -36 DR MOHAMED HASSAN EL GAMAL ST. 6TH DISTRICT NASR CITY, CAIRO EGYPTTOPICAL EXTERNAL GELS AND SOLS1.0X15.0 G TUBE,1.0X30.0 G TUBE01/07/2014
39NDA/MAL/HDP/0053H. LUNDBECK A/SPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDFLUANXOL DEPOTFLUPENTIXOL DECANOATE20MG/MLH. LUNDBECK A/S ,.,-OTTILIAVEJ 9, DK-2500, VALBY-COPENHAGEN DENMARKPARENTERAL RETARD AMPOULES1.0X1.0 ML AMPOULE01/07/2015
40NDA/MAL/HDP/0054GOOD DAY PHARMACY LIMITEDPLANET PHARMACEUTICALS UGANDA LTDFUNGOALCLOTRIMAZOLE1%W/WKREMOINT PHARMA PVT LTD---B-8 ADDITIONAL AMBERNATH MIDC OPP. ANAND NAGAR POLICE CHECK POST AMBERNATH (E) DIST THANE 421 506INDIATOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE01/07/2013
41NDA/MAL/HDP/0055H.LUNDBECK A/SPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDCLOPIXOL DEPOT ZUCLOPENTHIXOL DECANOATE200MG/MLH. LUNDBECK A/S ,.,-OTTILIAVEJ 9, DK-2500, VALBY-COPENHAGEN DENMARKPARENTERAL ORDINARY AMPOULES1.0X1.0 ML AMPOULE01/07/2015
42NDA/MAL/HDP/0056TROIKAA PHARMACEUTICALS LIMITEDABACUS PHARMA (AFRICA) LIMITEDDYNAPAR QPSDICLOFENAC4%W/VTROIKAA PHARMACEUTICALS LTD-THOL VILLAGE, DIST. MEHSANA- 382728, GUJARAT, INDIA TROIKAA PHARMACEUTICALS LTD-BLOCK NO. 2019, 2020, 2023, VILLAGE VIROCHANNAGAR, TAL-SANAND CITY: AHMEDABAD, DIST. AHMEDABAD-382170, GUJARAT STATE INDIATOPICAL EXTERNAL SPRAYS WITHOUT GAS1.0X30.0 ML BOTTLE,1.0X15.0 ML BOTTLE01/07/2015
43NDA/MAL/HDP/0058NIRMA LIMITED.LIFE PHARMA AFRICA LIMITEDWATER FOR INJECTION B.P.WATER FOR INJECTIONN/AACULIFE HEALTHCARE PVT. LTD-VILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARAT INDIAPARENTERAL ORDINARY AMPOULES1.0X5.0 ML AMPOULE,1.0X10.0 ML AMPOULE01/07/1997
44NDA/MAL/HDP/0059NABIQASIM INDUSTRIES (PVT) LTD.JEET PHARMACEUTICALS LIMITEDVAGIBACT CREAMCLINDAMYCIN PHOSPHATE2%W/WNABIQASIM INDUSTRIES (PVT) LTD?-17/24,KORANGI INDUSTRIAL AREA, KORANGI, KARACHI- PAKISTAN.
PAKISTANTOPICAL EXTERNAL CREAMS1.0X40.0 G TUBE + 1 APPLICATOR01/07/2006
45NDA/MAL/HDP/0060MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDGONAL-F PEN 300 IU/0,5 ML (22 µG/0,5 ML)FOLLITROPIN ALFA22 µG/0,5 MLMERCK SERONO SPA (BARI)-VIA DELLE MAGNOLIE, 15 (LOC FRAZ ZONA INDUSTRIALE) 70026, MODUGNO, BARI SWITZERLAND ITALYPARENTERAL ORDINARY PRE-FILLED PENS1.0X1.0 CARTRIDGE PREFILLED PEN + 8 NEEDLES FOR INJECTION01/07/2015
46NDA/MAL/HDP/0063HETERO LABS LTDAIVEEN (U) LIMITEDABACAVIR SULPHATE + LAMIVUDINEABACAVIR SULFATE + LAMIVUDINE600MG + 300MGHETERO LABS LTD. UNIT (V)-439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE),
JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA.
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X30.0 TABLET CONTAINER01/07/2015
47NDA/MAL/HDP/0064MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDGONAL-F PEN 450 IU/ IE 0,75 ML (33 µG)FOLLITROPIN ALFA33µG/ 0.7MLMERCK SERONO S.A. (MSA) -1170 SUCCURSALE D’AUBONNE ZONE INDUSTRIELLE DE L’OURIETTAZ, SWITZERLAND SWITZERLANDPARENTERAL ORDINARY CARTRIDGES1.0X1.0 CARTRIDGE PREFILLED PEN + 12 NEEDLES FOR INJECTION01/07/2015
48NDA/MAL/HDP/0065HOVID BHDUNITED HEALTHCARE DISTRIBUTORS LTDALENDRONATE 70MGALENDRONATE SODIUM70MGHOVID BHD-LOT 56442 7 1/2 MILES JALAN IPOH / CHEMOR 31200 CHEMORMALAYSIAORAL SOLID ORDINARY TABLETS1.0X4.0 TABLET BLISTER01/07/2015
49NDA/MAL/HDP/0067SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDARTEES?-? ARTEETHER75MG/MLSAKAR HEALTHCARE PVT LTD --406, SILVER OAKS COMMERCIAL COMPLEX, INDIAPARENTERAL ORDINARY AMPOULES1.0X3.2 ML AMPOULE01/07/2013
50NDA/MAL/HDP/0069PFIZER LABORATORIES PTY LTDLABOREX UGANDA LIMITEDLIPITORATORVASTATIN10MGPFIZER LABORATORIES-GODECKE MOOSWALDALLE 179090 FR ,PFIZER PHARMACEUTICALS LLC, ROAD 689 KM 1.9 VEGA BAJA, PUERTO RICO GERMANYORAL SOLID ORDINARY TABLETS1.0X28.0 TABLET BLISTER01/07/1999
51NDA/MAL/HDP/0070PFIZER LABORATORIES PTY LTDLABOREX UGANDA LIMITEDLIPITORATORVASTATIN20MGPFIZER LABORATORIES-GODECKE MOOSWALDALLE 179090 FR ,PFIZER PHARMACEUTICALS LLC, ROAD 689 KM 1.9 VEGA BAJA, PUERTO RICO GERMANYORAL SOLID ORDINARY TABLETS1.0X28.0 TABLET BLISTER01/07/1999
52NDA/MAL/HDP/0072VHB MEDI SCIENCES LTDLLOYDS PHARMACY LIMITEDAMTERICINAMPHOTERICIN50MGVHB MEDI SCIENCES LTD-PLOT 20, 21, 22 & 49,50, 51. INTEGRATED INDUSTRIAL AREA SECTOR 5, RUDRAPUR, UTTARAKHAND - INDIA INDIAPARENTERAL ORDINARY VIALS1.0X50.0 MG VIAL01/07/2013
53NDA/MAL/HDP/0073NAARI LTDECHO PHARMACY (U) LIMITEDFASILE-ONELEVONORGESTREL TABLETS BP1.5MGNAARI PHARMA PRIVATE LIMITED-PLOT NO. 14-16, 55-57, SECTOR-5, IIE, PANT NAGAR RUDRAPUR-263153 DIST-U.S. NAGAR UTTARAKHAND INDIAORAL SOLID ORDINARY TABLETS1.0X1.0 TABLET BLISTER01/07/2013
54NDA/MAL/HDP/0075SUN PHARMACEUTICAL INDUSTRIES LIMITEDSTAR PHARMACEUTICALS LTDSYNRIAMARTEROLANE MALEATE + PIPERAQUINE PHOSPHATE150 MG + 750 MGSUN PHARMACEUTICALS IND. LTD-B-2,MADAKAI INDUSTRIAL ESTATE, PONDA,GOA-403404, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0 TABLET BLISTER01/07/2014
55NDA/MAL/HDP/0077PHARMACIE BETHELABACUS PARENTERAL DRUGS LIMITEDX-SONEDEXAMETHASONE SODIUM PHOSPHATE0.1 % W/VABACUS PARENTERAL DRUGS LTD.-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE,
MUKONO
UGANDAOPHTHALMIC DROPS1.0X10.0 ML VIAL01/07/2015
56NDA/MAL/HDP/0079MYLAN LABS LTDNORVIK ENTERPRISES LIMITEDREVOKE 72LEVONORGESTREL750MCGMYLAN LABORATORIES LIMITED.--PLOT NO. 1606-1609, SARIGAM INDUSTRIAL AREA, GIDC, SARIGAM, TAL-UMERGAM, DIST VALSAD, 396155, GUJARAT, INDIA. MYLAN LABORATORIES LIMITED..-PLOT NO.20 & 21, PHARMEZ, SARKHEJ-BAVLA NATIONAL HIGHWAY NO. 08A, NEAR VILLAGE MATODA, TAL-SANAND, AHMEDABAD, GUJARAT, INDIA 382213 INDIAORAL SOLID ORDINARY TABLETS1.0X2.0 TABLET BLISTER01/07/2014
57NDA/MAL/HDP/0081ANKUR DRUGS AND PHARMA LTDJOINT MEDICAL STORE (UPMB - UCMB)VEXAPEN-625AMOXICILLIN + CLAVULANATE500 MG + 125 MGANKUR DRUGS AND PHARMA LTD- UNIT I-VILLAGE – MANAKPUR, PO – LODHIMAJRA, NALAGARH DIST.
SOLAN (HP) – 174 101(INDIA)
INDIAORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER01/07/2013
58NDA/MAL/HDP/0082ANKUR DRUGS AND PHARMA LTDJOINT MEDICAL STORE (UPMB - UCMB)CEPOVEX-50CEFPODOXIME PROXETIL50MGANKUR DRUGS AND PHARMA LTD- UNIT I-VILLAGE – MANAKPUR, PO – LODHIMAJRA, NALAGARH DIST.
SOLAN (HP) – 174 101(INDIA)
INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X60.0 ML BOTTLE01/07/2013
59NDA/MAL/HDP/0083MYLAN LABS LTDNORVIK ENTERPRISES LIMITEDZINNIA-FLEVONORGESTREL & ETHINYLESTRADIOL + FERROUS FUMARATE150MCG + 30MCG + 75MGMYLAN LABORATORIES LIMITED.--PLOT NO. 1606-1609, SARIGAM INDUSTRIAL AREA, GIDC, SARIGAM, TAL-UMERGAM, DIST VALSAD, 396155, GUJARAT, INDIA. MYLAN LABORATORIES LIMITED..-PLOT NO.20 & 21, PHARMEZ, SARKHEJ-BAVLA NATIONAL HIGHWAY NO. 08A, NEAR VILLAGE MATODA, TAL-SANAND, AHMEDABAD, GUJARAT, INDIA 382213 INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X28.0 TABLET BLISTER01/07/2014
60NDA/MAL/HDP/0084ANKUR DRUGS AND PHARMA LTDJOINT MEDICAL STORE (UPMB - UCMB)VEXIME CP-625CEFUROXIME AXETIL + POTASSIUM CLAVULANATE500MG + 125MGANKUR DRUGS AND PHARMA LTD- UNIT I-VILLAGE – MANAKPUR, PO – LODHIMAJRA, NALAGARH DIST.
SOLAN (HP) – 174 101(INDIA)
INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X4.0 TABLET BLISTER01/07/2014
61NDA/MAL/HDP/0085HETERO LABS LTD UNIT IXAIVEEN (U) LIMITEDPIOGEN-30PIOGLITAZONE HYDROCHLORIDE30MGHETERO LABS LTD. UNIT (V)-S.N0.439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE),
JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA
INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2015
62NDA/MAL/HDP/0086ANKUR DRUGS AND PHARMA LTDJOINT MEDICAL STORE (UPMB - UCMB)VEXAPEN -228.5AMOXICILLIN + CLAVULANATE200 MG + 28.5 MGANKUR DRUGS AND PHARMA LTD- UNIT I-VILLAGE – MANAKPUR, PO – LODHIMAJRA, NALAGARH DIST.
SOLAN (HP) – 174 101(INDIA)
INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE01/07/2013
63NDA/MAL/HDP/0087ANKUR DRUGS AND PHARMA LTDJOINT MEDICAL STORE (UPMB - UCMB)VEXAPEN CP-457AMOXICILLIN + CLAVULANATE400 MG + 57 MGANKUR DRUGS AND PHARMA LTD- UNIT I-VILLAGE – MANAKPUR, PO – LODHIMAJRA, NALAGARH DIST.
SOLAN (HP) – 174 101(INDIA)
INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE01/07/2013
64NDA/MAL/HDP/0088AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDD-LYTE CO-PACKANHYDROUS GLUCOSE/SODIUM CHLORIDE/TRISODIUM CITRATE/POTASSIUM CHLORIDE(2.7G/0.52G/0.58G/0.3G)/20MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL LIQUID ORDINARY COMBINATION PACK POWDERS/GRANULES4.0X500.0 ML SACHET + 1*10 BLISTERS,10.0X200.0 ML SACHET + 1*10 BLISTERS,2.0X1000.0 ML SACHET + 1*10 BLISTERS01/07/2015
65NDA/MAL/HDP/0089ANKUR DRUGS AND PHARMA LTDJOINT MEDICAL STORE (UPMB - UCMB)CEPOVEX-200CEFPODOXIME PROXETIL200MGANKUR DRUGS AND PHARMA LTD- UNIT I-VILLAGE – MANAKPUR, PO – LODHIMAJRA, NALAGARH DIST.
SOLAN (HP) – 174 101(INDIA)
INDIAORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET STRIP01/07/2013
66NDA/MAL/HDP/0093ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDLORASLORATADINE10MGASTRA LIFE CARE (INDIA) PVT-SURVEY NO.57/P, SARKHEJ-BAVLA HIGHWAY, POST- RAJOD-382220, TALUKA-BAVLA, DIST-AHMEDABAD. INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER01/07/2013
67NDA/MAL/HDP/0095NORVATIS PHARMA SERVICES INC.SURGIPHARM (U) LIMITEDCURAMAMOXICILLIN + CLAVULANATE125MG + 31.25MG/5MLSANDOZ GMBH (NORVATIS PHARMA SERVICES INC) -BIOCHEMIESTRABE 10, A-6250 KUNDL, TYROL INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X60.0 ML BOTTLE07/01/2014
68NDA/MAL/HDP/0096ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDLIPORATORVASTATIN20MGASTRA LIFE CARE (INDIA) PVT-SURVEY NO.57/P, SARKHEJ-BAVLA HIGHWAY, POST- RAJOD-382220, TALUKA-BAVLA, DIST-AHMEDABAD. INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X15.0 TABLET BLISTER01/07/2015
69NDA/MAL/HDP/0097MSN LABORATORIES LTDMETRO PHARMACEUTICALS LIMITEDSAFELEVO 750LEVOFLOXACIN 750MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2013
70NDA/MAL/HDP/0098MSN LABORATORIES LTDMETRO PHARMACEUTICALS LIMITEDATOREM 10ATORVASTATIN10MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2013
71NDA/MAL/HDP/0099ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDCARBASCARBAMAZEPINE200MGASTRA LIFE CARE (INDIA) PVT-SURVEY NO.57/P, SARKHEJ-BAVLA HIGHWAY, POST- RAJOD-382220, TALUKA-BAVLA, DIST-AHMEDABAD. INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER01/07/2014
72NDA/MAL/HDP/0101AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOTETRA CAPSULES (THANE)TETRACYCLINE HYDROCHLORIDE250MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY CAPSULES10.0X10.0 CAPSULE BLISTER,1.0X500.0 CAPSULE CONTAINER,1.0X1000.0 CAPSULE CONTAINER,1.0X100.0 CAPSULE CONTAINER,1.0X100.0X10.0 CAPSULE BLISTER01/07/1998
73NDA/MAL/HDP/0102MSN LABORATORIES LTDMETRO PHARMACEUTICALS LIMITEDSILMELT 100SILDENAFIL CITRATE100MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X2.0 TABLET BLISTER01/07/2014
74NDA/MAL/HDP/0103MSN LABORATORIES LTDMETRO PHARMACEUTICALS LIMITEDATOREM 20ATORVASTATIN20MGMSN LABORATORIES LTD- PLOT N0.42, ANRICH INDUSTRIAL ESTATE INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2013
75NDA/MAL/HDP/0104MSN LABORATORIES LTDMETRO PHARMACEUTICALS LIMITEDSILMELT 50SILDENAFIL CITRATE50MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY TABLETS1.0X2.0X2.0 TABLET BLISTER01/07/2014
76NDA/MAL/HDP/0105AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOSPRIN TABLETSACETYL SALICYLIC ACID300MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY TABLETS10.0X10.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER01/07/1998
77NDA/MAL/HDP/0106MSN LABORATORIES LTDPLANET PHARMACEUTICALS UGANDA LTDSAFELEVOLEVOFLOXACIN500MG/100MLMARCK BIOSCIENCES -PLOT NO 876, NH NO 8 HARIYALA KHEDA- 387411 GUJARAT, INDIA INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X1.0X100.0 ML BOTTLE01/07/2013
78NDA/MAL/HDP/0110MSN LABORATORIES LTDPLANET PHARMACEUTICALS UGANDA LTDSAFETELMI 40TELMISARTAN40MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2013
79NDA/MAL/HDP/0111MSN LABORATORIES LTDPLANET PHARMACEUTICALS UGANDA LTDSAFETELMI 80TELMISARTAN80MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2013
80NDA/MAL/HDP/0112NORVATIS PHARMA AGSURGIPHARM (U) LIMITEDEXFORGE 5MG/160MGAMLODIPINE + VALSARTAN5 MG + 160 MGNOVARTIS PHARMA STEIN AG-H-4332 STEIN SCHAFFAUSERTRASSE NOVARTIS FARMACEUTICA SA-RONDA DE SANTA MARIA,158, E-08210 BARBERA DEL VALLES BARCELONA SPAIN SWITZERLANDORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X14.0 TABLET BLISTER01/07/2007
81NDA/MAL/HDP/0114MSN LABORATORIES LTDMETRO PHARMACEUTICALS LIMITEDBREATHEZY 4MONTELUKAST SODIUM4MGMSN LABORATORIES LTD -PLOT NO. 42 INDUSTRIAL ESTARE BOLLARAM MEDAK DISTRIC 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY CHEWABLE TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2013
82NDA/MAL/HDP/0116MSN LABORATORIES LTDMETRO PHARMACEUTICALS LIMITEDBREATHEZY CW 5MONTELUKAST SODIUM5MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY CHEWABLE TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2013
83NDA/MAL/HDP/0117ALKEM LABORATORIES LIMITEDABACUS PHARMA (AFRICA) LIMITEDZOCEF 1.5GCEFUROXIME SODIUM1.5GALKEM LABORATORIES LTD-VILLAGE – THANA, BADDI TEHSIL – NALAGARH, DIST-SOLAN (HP), INDIA – 173205 INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0X1.5 G VIAL01/07/2013
84NDA/MAL/HDP/0118ALKEM LABORATORIES LIMITEDABACUS PHARMA (AFRICA) LIMITEDZOCEF 750MGCEFUROXIME SODIUM750MGALKEM LABORATORIES LTD-VILLAGE – THANA, BADDI TEHSIL – NALAGARH, DIST-SOLAN (HP), INDIA – 173205 INDIAPARENTERAL ORDINARY DRY VIALS1.0X750.0 MG VIAL01/07/2013
85NDA/MAL/HDP/0119DAWA LIMITEDSUPER MEDIC LTDDACOLDCAFFEINE ANHYDROUS+CHLORPHENIRAMINE MALEATE+PARACETAMOL+PSEUDOEPHEDRINE30MG+4MG+400MG+30MGDAWA LIMITED -BABA DOGO RWARAKAKENYAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER01/07/2013
86NDA/MAL/HDP/0120ABOTT LABORATORIES S.A (PTY) LIMITEDHARLEYS UGANDA LIMITEDTARKA 240/4VERAPAMIL HYDROCHLORIDE + TRANDOLAPRIL240MG/4MGABOTT GMBH & CO KG -KNOLLSTRASSE 67061 LUDWIGSHAFENGERMANYORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2013
87NDA/MAL/HDP/0121SHELYS PHARMACEUTICALS LTDBETA HEALTHCARE UGANDA LIMITEDPEDZINCZINC SULPHATE20MGSHELYS PHAMACEUTICALS LTD .-NEW BAGAMOYO RD, MWENGE, PLOT 696, DAR ES SALAAM TANZANIAORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER01/07/2015
88NDA/MAL/HDP/0122NABROS PHARMA PVT LTDSHREEJI PHARMACEUTICALS LIMITEDLEVOXINE-500LEVOFLOXACIN HEMIHYDRATE500MG NABROS PHARMA PVT LTD-. SURVEY NO. 110/A/2, AMIT FARM, JAIN UPASRAYA, NEAR COCA COLA FACTORY N.H NO. 8 KAJIPURA KHEDA 387 411 INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER01/07/2015
89NDA/MAL/HDP/0124DAWA LIMITEDSUPER MEDIC LTDAMPECINAMPICILLIN TRIHYDRATE125MG/5MLDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE01/07/2015
90NDA/MAL/HDP/0125DAWA LIMITEDSUPER MEDIC LTDSULPHUR OINTMENTSULPHUR10%W/WDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYATOPICAL EXTERNAL OINTMENTS1.0X20.0 G TUBE01/07/2013
91NDA/MAL/HDP/0126DAWA LIMITEDSUPER MEDIC LTDWHITFIELD'SBENZOIC ACID + SALICYLIC ACID6.0%W/W +3.0%W/WDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYATOPICAL EXTERNAL OINTMENTS1.0X20.0 G TUBE01/07/2014
92NDA/MAL/HDP/0127DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDCORYCARDONIRBESARTAN + HYDROCHLOROTHIAZIDE300MG + 12.5MG ZHEJIANG HUAHAI PHARMACEUTICAL CO. LTD-XUNQIAO, LINHAI, ZHEJIANG PROVINCE 317024 PEOPLES’ REPUBLIC OF CHINA CHINAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2013
93NDA/MAL/HDP/0128DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDCORYCARDONIRBESARTAN + HYDROCHLOROTHIAZIDE150MG + 12.5MG ZHEJIANG HUAHAI PHARMACEUTICAL CO. LTD-XUNQIAO, LINHAI, ZHEJIANG PROVINCE 317024 PEOPLES’ REPUBLIC OF CHINA CHINAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2013
94NDA/MAL/HDP/0129HETERO LABS LTDAIVEEN (U) LIMITEDPIOGENPIOGLITAZONE HYDROCHLORIDE15MGHETERO LABS LIMITED UNIT V-APIIC PHARMA SEZ, S. NO. 439, 440, 441 & 458 POLEPALLY VILLAGE, JADCHERLA MANDAL, MAHABOOBNAGAR (DISTRICT). PIN 509301 INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2015
95NDA/MAL/HDP/0130CADILA PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.TRIGAN -DDICYCLOMINE HYDROCHLORIDE10MG/MLCADILA PHARMACEUTICALS LIMITED-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA INDIAPARENTERAL ORDINARY AMPOULES1.0X2.0 ML AMPOULE01/07/2015
96NDA/MAL/HDP/0131ABBOT LABORATORIES S.A. (PTY) LTDHARLEYS UGANDA LIMITEDKLACID P125CLARITHROMYCIN125MG/5MLABBOTT LABORATORIES S.A (PTY) LTD-ABBOTT PLACE,219 GOLF CLUB
TERRACE,CONSTANTIA KLOOF 1709 P.O BOX 7208 WELTEVREDENPARK 1715
SOUTH AFRICAORAL LIQUID ORDINARY OTHER POWDERS/GRANULES1.0X50.0 ML BOTTLE,1.0X100.0 ML BOTTLE01/07/1998
97NDA/MAL/HDP/0132ABBOT LABORATORIES S.A. (PTY) LTDHARLEYS UGANDA LIMITEDKLACID 500MGCLARITHROMYCIN500MGABBOTT LABORATORIES S.A (PTY) LTD-ABBOTT PLACE,219 GOLF CLUB
TERRACE,CONSTANTIA KLOOF 1709 P.O BOX 7208 WELTEVREDENPARK 1715
SOUTH AFRICAORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER,1.0X14.0 TABLET BLISTER01/07/1998
98NDA/MAL/HDP/0133ABBOT LABORATORIES S.A. (PTY) LTDHARLEYS UGANDA LIMITEDKLACID P250CLARITHROMYCIN250MG/5MLABBOTT LABORATORIES S.A (PTY) LTD-ABBOTT PLACE,219 GOLF CLUB
TERRACE,CONSTANTIA KLOOF 1709 P.O BOX 7208 WELTEVREDENPARK 1715
SOUTH AFRICAORAL LIQUID ORDINARY OTHER POWDERS/GRANULES1.0X50.0 ML BOTTLE,1.0X100.0 ML BOTTLE01/07/1998
99NDA/MAL/HDP/0135SHELYS PHARMACEUTICALS LTDBETA HEALTHCARE UGANDA LIMITEDHEMOVIT SYRUPIRON + FOLIC ACID + PYRIDOXINE + CYANOCOBALAMIN + ZINC200MG + 1.5MG + 0.5MG + 50 MCG + 2.33MGSHELYS PHAMACEUTICALS LTD .-NEW BAGAMOYO RD, MWENGE, PLOT 696, DAR ES SALAAM TANZANIAORAL LIQUID ORDINARY SYRUPS1.0X200.0 ML BOTTLE01/07/2013
100NDA/MAL/HDP/0139ANGLIAN NUTRITION PRODUCTS COMPANYSUPER MEDIC LTDMOXAFORTEFLUCLOXACILLIN SODIUM + AMOXICILLIN TRIHYDRATE250MG + 250MGDAWA PHARMACEUTICALS LIMITED-PLOT 7879, BABA DOGO ROAD RUARAKA KENYAORAL SOLID ORDINARY CAPSULES1.0X2.0X10.0 CAPSULE BLISTER01/07/2014
101NDA/MAL/HDP/0141COSMOS LTDASTRA PHARMA (U) LIMITEDNYCOSTAT SUSPENSIONNYSTATIN100,000 I.U/MLCOSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA KENYAORAL LIQUID ORDINARY SUSPENSIONS1.0X30.0 ML BOTTLE01/07/1998
102NDA/MAL/HDP/0142PFIZER LAB LTDLABOREX UGANDA LIMITEDPREVENAR 13PNEUMOCOCCAL POLYSACCHARIDE CONJUGATE VACCINE (13-VALENT.ADSORBED)2.2MCG OF POLYSACCHARIDE FOR SEROTYPES 1,3,4,5,6A,7F.9V,14,18C,19A,19F,23F,AND 4.4MCG FOR SEROTYPE 6BWYETH PHARMACEUTICALS INC-401 N MIDDLETOWN RD PEARL RIVER NY 10965UNITED STATESPARENTERAL ORDINARY VIALS1.0X0.5 ML VIAL (1 DOSE)01/07/2011
103NDA/MAL/HDP/0144MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIAKIMSY MEDS LTDNEXQUIN 500LEVOFLOXACIN500MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER01/07/2013
104NDA/MAL/HDP/0145MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIAKIMSY MEDS LTDTELKAST 10MONTELUKAST SODIUM10MGMSN LABORATORIES LTD -PLOT NO. 42 INDUSTRIAL ESTARE BOLLARAM MEDAK DISTRIC 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2013
105NDA/MAL/HDP/0148MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIAKIMSY MEDS LTDSYNCLAV 1000AMOXICILLIN + CLAVULANATE POTASSIUM875 MG + 125 MGMEDREICH LIMITED UNIT 1-12TH MILE, OLD MADRAS ROAD, VIRGONAGAR, BANGOLORE-560049 MEDOPHARM PVT LTD -NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY-603203 TAMIL NADU INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X7.0 TABLET BLISTER01/07/2013
106NDA/MAL/HDP/0149MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIAKIMSY MEDS LTDSYNCLAV 625AMOXICILLIN + POTASSIUM CLAVULANATE500 MG + 125 MGMEDREICH LIMITED –UNIT I-12TH MILE, OLD MADRAS ROAD, VIRGONAGAR
BANGALORE-560 049, INDIA
MEDOPHARM PVT LTD -NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY-603203 TAMIL NADU
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X7.0 TABLET BLISTER01/07/2013
107NDA/MAL/HDP/0150MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIAKIMSY MEDS LTDSYNCLAV 228AMOXYCILLIN + CLAVULANATE POTASSIUM200 MG + 28.5 MGMEDREICH LIMITED –UNIT I-12TH MILE, OLD MADRAS ROAD, VIRGONAGAR
BANGALORE-560 049, INDIA
INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X70.0 ML BOTTLE01/07/2013
108NDA/MAL/HDP/0151MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIAKIMSY MEDS LTDCARDITEL 80TELMISARTAN80MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2013
109NDA/MAL/HDP/0152DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDRYCARDON 150IRBESARTAN150MG ZHEJIANG HUAHAI PHARMACEUTICAL CO. LTD-XUNQIAO, LINHAI, ZHEJIANG PROVINCE 317024 PEOPLES’ REPUBLIC OF CHINA DELORBIS PHARMACEUTICALS LTD-17 ATHINON STR., ERGATES INDUSTRIAL AREA, 2643 ERGATES, P.O. BOX 28629, 2081 LEFKOSIA, CYPRUS CHINAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2013
110NDA/MAL/HDP/0153DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDRYCARDON 300IRBESARTAN300MG ZHEJIANG HUAHAI PHARMACEUTICAL CO. LTD-XUNQIAO, LINHAI, ZHEJIANG PROVINCE 317024 PEOPLES’ REPUBLIC OF CHINA DELORBIS PHARMACEUTICALS LTD-17 ATHINON STR., ERGATES INDUSTRIAL AREA, 2643 ERGATES, P.O. BOX 28629, 2081 LEFKOSIA, CYPRUS CHINAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2013
111NDA/MAL/HDP/0155TORRENT PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.ASTHATOR 10MONTELUKAST SODIUM10MGTORRENT PHARMACEUTICALS LTD .,-AHMEDABAD-MEHSANA HIGHWAY, TALUKA-KADI, DIST. MEHSANA, INDRAD-382721, GUJARAT INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2013
112NDA/MAL/HDP/0157RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDRECODINCODEINE PHOSPHATE + CHLORPHENIRAMINE MALEATE10MG + 4MG /5MLRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA UGANDAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE01/07/2015
113NDA/MAL/HDP/0158MEGA LIFESCIENCES (AUSTRALIA) PTY LTDABACUS PHARMA (AFRICA) LIMITEDKIPEL 10MONTELUKAST SODIUM10MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2015
114NDA/MAL/HDP/0160UNICHEM LABORATORIES LTDEUROPA HEALTHCARE (U) LTDTIZIGESICTIZANIDINE HYDROCHLORIDE2MGUNICHEM LABORATORIES LIMITED-C–31,32 & D-10, INDUSTRIAL AREA, MEERUT ROAD, GHAZIABAD, U.P. INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2016
115NDA/MAL/HDP/0161RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDTRAMARENTRAMADOL HYDROCHLORIDE50MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA UGANDAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER01/07/2014
116NDA/MAL/HDP/0162RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDCOSYP-D LINCTUSDEXTROMETHORPHAN HYDROBROMIDE + CHLORPHENAMINE MALEATE10MG +4MG /5MLRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA UGANDAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE01/07/2015
117NDA/MAL/HDP/0163RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDPHENARENPROMETHAZINE HYDROCHLORIDE5MG/5MLRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA UGANDAORAL LIQUID ORDINARY SYRUPS1.0X60.0 ML BOTTLE01/07/2015
118NDA/MAL/HDP/0164RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDRENPRESSPROPRANOLOL40MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA UGANDAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2014
119NDA/MAL/HDP/0165TORRENT PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.TOLANZ 5OLANZAPINE ORODISPERSIBLE TABLETS5MGTORRENT PHARMACEUTICALS LTD .,-AHMEDABAD-MEHSANA HIGHWAY, TALUKA-KADI, DIST. MEHSANA, INDRAD-382721, GUJARAT INDIAORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2013
120NDA/MAL/HDP/0166RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDX-PELMEBENDAZOLE100MG/5MLRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA UGANDAORAL LIQUID ORDINARY SUSPENSIONS1.0X30.0 ML BOTTLE01/07/2015
121NDA/MAL/HDP/0167TORRENT PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.TOLANZ 10OLANZAPINE ORODISPERSIBLE TABLETS10MGTORRENT PHARMACEUTICALS LTD .,-AHMEDABAD-MEHSANA HIGHWAY, TALUKA-KADI, DIST. MEHSANA, INDRAD-382721, GUJARAT INDIAORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2013
122NDA/MAL/HDP/0168MSN LABORATORIES LTDMETRO PHARMACEUTICALS LIMITEDFEBUDAYFEBUXOSTAT80MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2014
123NDA/MAL/HDP/0169ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDROSUVAX 10ROSUVASTATIN10MGASTRA LIFE CARE (INDIA) PVT-SURVEY NO.57/P, SARKHEJ-BAVLA HIGHWAY, POST- RAJOD-382220, TALUKA-BAVLA, DIST-AHMEDABAD. INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X15.0 TABLET BLISTER01/07/2015
124NDA/MAL/HDP/0174GLAXO SMITHKLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDFLIXOTIDE 50FLUTICASONE PROPIONATE50MCGGLAXO WELLCOME S.A.-AVENIDA DE EXTREMADURA 3
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125NDA/MAL/HDP/0175BAYER SCHERING PHARMASURGIPHARM (U) LIMITEDXARELTO 10MGRIVAROXABAN10MGBAYER HEALTHCARE AG,-D-51368, LEVERKUSEN GERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X10.0 TABLET BLISTER01/07/2013
126NDA/MAL/HDP/0177MSN LABORATORIES LTDPLANET PHARMACEUTICALS UGANDA LTDILET B2GLIMEPIRIDE+METFORMIN HYDROCHLORIDE2MG+500 MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2014
127NDA/MAL/HDP/0178REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDCOLDCAP DAYTIME AND NIGHT TIME CAPSULEDAY TIME(PARACETAMOL +CAFFEINE ANHYDROUS+PSEUDOEPHEDRINE HCL) AND NIGHT TIME(PARACETAMOL +CHLORPHENIRAMINE MALEATE)DAY TIME (500MG + 30MG + 30MG) AND NIGHT TIME (500MG +2MG)REGAL PHARMACEUTICALS LIMITED -PLOT 7879/18 OF BABA DOGO ROAD, RUARAKA, NAIROBI KENYAORAL SOLID ORDINARY CAPSULES1.0X3.0X8.0 CAPSULE BLISTER01/07/2013
128NDA/MAL/HDP/0182MSN LABORATORIES LTDMETRO PHARMACEUTICALS LIMITEDFEBUDAY 40FEBUXOSTAT40MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2014
129NDA/MAL/HDP/0186WIDE SPECTRUM ENTERPRISES (U) LIMITEDWIDE SPECTRUM ENTERPRISES (U) LIMITEDBBC SPRAYBENZOCAINE+BENZYDAMINE+CATALKONIUM CHLORIDE1.5%W/V+0.15%W/V+0.0413%W/VAMOUN PHARMACEUTICALS CO. S.A.E-1ST INDUSTRIAL ZONE, EL-OBOUR CITY, EGYPT. EGYPTORAL TOPICAL SPRAYS WITHOUT GAS1.0X25.0 ML BOTTLE01/07/2014
130NDA/MAL/HDP/0187AMOUN PHARMACEUTICAL COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDKAPRON TABLETTRANEXAMIC ACID500 MGAMOUN PHARMACEUTICALS CO. S.A.E-1ST INDUSTRIAL ZONE, EL-OBOUR CITY, EGYPT. EGYPTORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER01/07/2014
131NDA/MAL/HDP/0188AMOUM PHARMACEUTICALS LTDBOOTS PHARMACEUTICALS LIMITEDLEVOXINLEVOFLOXACIN500MGAMOUN PHARMACEUTICALS CO. S.A.E-1ST INDUSTRIAL ZONE, EL-OBOUR CITY, EGYPT. EGYPTORAL SOLID ORDINARY FILM-COATED TABLETS1.0X5.0 TABLET BLISTER01/07/2014
132NDA/MAL/HDP/0189CIPLA LTDQUALITY CHEMICALS LTD - HUMANNEVIMUNE TABLETSNEVIRAPINE200MGCIPLA LTD--PLOT NO L-139,VERNA IND ESTATE, VERNA GOA-403 INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X6.0X10.0 TABLET BLISTER,1.0X60.0 TABLET CONTAINER01/07/2001
133NDA/MAL/HDP/0190AMOUN PHARMACEUTICAL COMPANYBOOTS PHARMACEUTICALS LIMITEDACNE FREE CREAMTRETINOIN50MGAMOUN PHARMACEUTICALS CO. S.A.E-1ST INDUSTRIAL ZONE, EL-OBOUR CITY, EGYPT. EGYPTTOPICAL EXTERNAL CREAMS1.0X30.0 G TUBE01/07/2014
134NDA/MAL/HDP/0191MEDOPHARM PRIVATE LIMITEDPLANET PHARMACEUTICALS UGANDA LTDCLEDOMOX 228.5AMOXICILLIN + CLAVULANATE200 MG + 28.5 MGMEDOPHARM PVT LTD.-NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADUINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X70.0 ML BOTTLE01/07/2013
135NDA/MAL/HDP/0192AMOUN PHARMACEUTICALS COMPANYBOOTS PHARMACEUTICALS LIMITEDAMOCOMB CREAMNEOMYCIN + TRIAMCINOLONE ACETONIDE + GRAMICIDIN0.25GM + 0.1G + 100000IU + 0.025G/100GAMOUN PHARMACEUTICALS CO. S.A.E-1ST INDUSTRIAL ZONE, EL-OBOUR CITY, EGYPT. EGYPTTOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE01/07/2014
136NDA/MAL/HDP/0193MEDOPHARM PRIVATE LIMITEDPLANET PHARMACEUTICALS UGANDA LTDCLEDOMOX 625AMOXICILLIN + CLAVULANIC ACID500 MG + 125 MGMEDOPHARM PVT LTD.-NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADUINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X7.0 TABLET BLISTER01/07/2013
137NDA/MAL/HDP/0196CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDCIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDDUOVIRLAMIVUDINE/ZIDOVUDINE150MG/300MGCIPLA QUALITY CHEMICAL INDUSTRIES LIMITED - -PLOT 1-7 1ST RING ROAD, LUZIRA, KAMPALA UGANDAORAL SOLID ORDINARY OTHER COATED TABLETS1.0X60.0 TABLET CONTAINER01/07/2013
138NDA/MAL/HDP/0197CIPLA LTDQUALITY CHEMICALS LTD - HUMANEFAVIR-600EFAVIRENZ600MGCIPLA QUALITY CHEMICAL INDUSTRIES LIMITED - -PLOT 1-7 1ST RING ROAD, LUZIRA, KAMPALA CIPLA LTD -PLOT NO. L-139, VERNA, GOA 403 722 INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET CONTAINER01/07/2004
139NDA/MAL/HDP/0198CIPLA LIMITEDCIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDNEVIRAPINE TABLETS 200 MGNEVIRAPINE200MGCIPLA QUALITY CHEMICAL INDUSTRIES LIMITED - -PLOT 1-7 1ST RING ROAD, LUZIRA, KAMPALA UGANDAORAL SOLID ORDINARY TABLETS1.0X60.0 TABLET BOTTLE01/07/2013
140NDA/MAL/HDP/0201GLAXO SMITH KLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDFLIXOTIDE 125FLUTICASONE PROPIONATE125MCGGLAXO WELLCOME S.A.-AVENIDA DE EXTREMADURA 3
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141NDA/MAL/HDP/0203GLAXOSMITHLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDSERETIDE EVOHALER 250SALMETEROL XINAFOATE + FLUTICASONE PROPIONATE25MCG + 250MCGGLAXO WELLCOME-PRODUCTION ZONE INDUSTRIELLE NO. 2 23, RUE LAVOISIER 27000 EVREUX FRANCELUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER1.0X120.0 METERED DOSE CANNISTER01/07/2015
142NDA/MAL/HDP/0204GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDTIVICAYDOLUTEGRAVIR SODIUM50MGGLAXO OPERATIONS UK LTD-WARE SG120DJ UNITED KINGDOMUNITED KINGDOMORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET CONTAINER01/07/2015
143NDA/MAL/HDP/0205MACLEODS PHARMACEUTICALS LTDS LTDNORVIK ENTERPRISES LIMITEDTENOFOVIR DISOPROXIL FUMARATETENOFOVIR DISOPROXIL FUMARATE300MGMACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET BOTTLE01/07/2013
144NDA/MAL/HDP/0206MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIAKIMSY MEDS LTDCARDITEL 40TELMISARTAN40MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2013
145NDA/MAL/HDP/0207MACLEODS PHARMACEUTICAL LTDNORVIK ENTERPRISES LIMITEDLAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATELAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE300MG +300MGMACLEODS PHARMACEUTICALS LTD---PLOT NO 25-27 SURVEY PREMEIRE INDUSTRIAL ESTATE KACHIGAM DAMAN (U.T) 396401 MACLEODS PHARMACEUTICALS LIMITED (BLOCK –N1)-VILLAGE THEDA, P.O. LODHI MAJRA,TEHSIL BADDI, HIMACHAL PRADESH -174101,INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X30.0 TABLET BOTTLE10/07/2013
146NDA/MAL/HDP/0209HETERO LABS LTDAIVEEN (U) LIMITEDABACAVIR SULPHATE ORAL SOLUTIONABACAVIR SULPHATE20MG/MLHETERO LABS LTD, UNIT III-KALYANPUR, CHAKKAN ROAD, BADDI, DIST. SOLAN, HIMACHAL PRADESH, INDIA INDIAORAL LIQUID ORDINARY LIQUIDS1.0X240.0 ML BOTTLE01/07/2013
147NDA/MAL/HDP/0210MEDICAL UNION PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.HEPATICUMSILYMARIN140MGMEDICAL UNION PHARMACEUTICALS-36 DR MOHAMED HASSAN EL-GAMAL ST.6TH DISTRICT NASR CITY EGYPTEGYPTORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER01/07/2011
148NDA/MAL/HDP/0212MEDICAL UNION PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.HEPATICUMSILYMARIN1G/100MLMEDICAL UNION PHARMACEUTICALS-36 DR MOHAMED HASSAN EL-GAMAL ST.6TH DISTRICT NASR CITY EGYPTEGYPTORAL LIQUID ORDINARY SUSPENSIONS1.0X120.0 ML BOTTLE01/07/2012
149NDA/MAL/HDP/0213AUROBINDO PHARMA LTD (UNIT VI)PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDAUROPODOX 200CEFPODOXIME200MGAUROBINDO PHARMA LTD (UNIT VI) ,.,.,-SURVEY NOS. 329/39 & 329/47, CHITKUL VILLAGE, PATANCHERU MANDAL, MEDAK DISTRICT PIN CODE 502307, ANDHRA PRADESH INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER01/07/2013
150NDA/MAL/HDP/0217ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDPALETHERARTEMETHER80MG/MLLINCOLN PARENTERAL LTD .-11, TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. BOX KHATRAJ 382721 TA: KALOL DIST. GANDHINAGAR GUJARAT INDIAPARENTERAL ORDINARY I M AMPOULES2.0X3.0X1.0 ML AMPOULE01/07/2014
151NDA/MAL/HDP/0221DAWA LIMITEDSUPER MEDIC LTDAMPICLO-DAWAAMPICILLIN + CLOXACILLIN250 MG + 250 MGDAWA PHARMACEUTICALS LIMITED-PLOT 7879, BABA DOGO ROAD RUARAKA KENYAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER01/07/2013
152NDA/MAL/HDP/0222PHARMACIE BETHELABACUS PARENTERAL DRUGS LIMITEDAVIR-200ACYCLOVIR500MGLINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2013
153NDA/MAL/HDP/0223ABACUS PHARMA LTDABACUS PARENTERAL DRUGS LIMITEDTOPCID-150RANITIDINE150MGLINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET STRIP01/07/2013
154NDA/MAL/HDP/0225PHARMACIE BETHELABACUS PARENTERAL DRUGS LIMITEDDIKON PLUSDICLOFENAC/SALICYLATE/MENTHOL/LINSEED1%W/W+10%W/W+5%W/W+3%W/WLINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT INDIATOPICAL EXTERNAL GELS AND SOLS1.0X15.0 G CONTAINER01/07/2013
155NDA/MAL/HDP/0226AMOUM PHARMACEUTICALS LTDBOOTS PHARMACEUTICALS LIMITEDULTRASOLV SYRUPOXOMEMAZINE HCL & CARBOCYSTEINE & GUAIFENESIN2MG+125MG+100MG/5MLAMOUN PHARMACEUTICALS CO. S.A.E-1ST INDUSTRIAL ZONE, EL-OBOUR CITY, EGYPT. EGYPTORAL LIQUID ORDINARY SYRUPS1.0X120.0 ML BOTTLE01/07/2014
156NDA/MAL/HDP/0227AMOUM PHARMACEUTICALS LTDBOOTS PHARMACEUTICALS LIMITEDCYRINOL SYRUPPHOLCODINE+EPHEDRINE HCL +CARBINOXAMINE MALEATE4MG+7MG+2MG /5MLAMOUN PHARMACEUTICALS COMPANY-1ST INDUSTRIAL ZONE EL OBOUR CITY CAIRO EGYPTEGYPTORAL LIQUID ORDINARY SYRUPS1.0X60.0 ML BOTTLE01/07/2014
157NDA/MAL/HDP/0228KOPRAN LIMITEDTATA UGANDA LIMITEDTRIM-960TRIMETHOPRIM/SULFAMETHOXAZOLE160MG/800MGKOPRAN LTD-VILLAGE SAVROLI TAL KHARAPUR DIST RAIGAD 410 202INDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER01/07/2014
158NDA/MAL/HDP/0230STRIDES SHASUN LIMITEDDELMAW ENTERPRISES LIMITEDCOMBIARTARTHEMETHER + LUMEFANTRINE20MG +120MGSTRIDES SHASUN LIMITED-NO. 36/7, SURAGAJAKKANAHALLI, INDLAVADI CROSS, ANEKAL TALUK, BENGALURU, KARNATAKA, 562106 INDIAORAL SOLID ORDINARY TABLETS1.0X4.0X6.0 TABLET BLISTER,1.0X1.0X6.0 TABLET BLISTER,1.0X1.0X12.0 TABLET BLISTER,1.0X1.0X18.0 TABLET BLISTER,1.0X1.0X24.0 TABLET BLISTER,1.0X24.0 TABLET BLISTER01/07/2013
159NDA/MAL/HDP/0232TORRENT PHARAMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.BRANTALOSARTAN POTASSIUM + AMLODIPINE BESILATE50MG + 5MGTORRENT PHARMACEUTICALS LTD .,-AHMEDABAD-MEHSANA HIGHWAY, TALUKA-KADI, DIST. MEHSANA, INDRAD-382721, GUJARAT INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2013
160NDA/MAL/HDP/0233MEDOCHEMIE LTDBOOTS PHARMACEUTICALS LIMITEDCEFIMED 400CEFIXIME TRIHYDRATE400MGMEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY,FACTORY C-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIALAREA 4101 AGIOS ATHANASSIOUS LIMASSOL CYPRUS CYPRUSORAL SOLID ORDINARY FILM-COATED TABLETS1.0X5.0 TABLET BLISTER01/07/2014
161NDA/MAL/HDP/0234MEDOCHEMIE LTDBOOTS PHARMACEUTICALS LIMITEDCEFIMED 200CEFIXIME TRIHYDRATE200MGMEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY.-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA CYPRUSORAL SOLID ORDINARY FILM-COATED TABLETS1.0X8.0 TABLET BLISTER,1.0X2.0X5.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER01/07/2014
162NDA/MAL/HDP/0235MEDOCHEMIE LTDBOOTS PHARMACEUTICALS LIMITEDAXETINE 500CEFUROXIME AXETIL500MGMEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY.-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA CYPRUSORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET STRIP01/07/2014
163NDA/MAL/HDP/0236INDOCO REMEDIES LIMITEDTATA UGANDA LIMITEDCLOBCLOTRIMAZOLE1%W/WINDOCO REMEDIES LIMITED-L-14 VERNA INDUSTRIAL AREA VERNAINDIATOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE,1.0X15.0 G TUBE01/07/2004
164NDA/MAL/HDP/0237MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDKOMEFAN 280ARTEMETHER + LUMEFANTRINE40 MG + 240 MGMYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE
INDIAORAL SOLID ORDINARY TABLETS1.0X12.0 TABLET BLISTER01/07/2041
165NDA/MAL/HDP/0239MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDKOMEFAN 140ARTEMETHER + LUMEFANTRINE20 MG+ 120 MGMYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE
INDIAORAL SOLID ORDINARY TABLETS1.0X6.0X3.0 TABLET BLISTER,1.0X18.0 TABLET BLISTER,1.0X24.0 TABLET BLISTER01/07/2014
166NDA/MAL/HDP/0243UNIVERSAL CORPORATION LTDHARLEYS UGANDA LIMITEDLAMOZIDLAMIVUDINE + ZIDOVUDINE150MG +300MGUNIVERSAL CORPORATION LIMITED -PLOT 13777 KIKUYU ROAD, KIKUYU TOWN, PAST POST OFFICE KENYAORAL SOLID ORDINARY TABLETS1.0X60.0 TABLET BOTTLE01/07/2013
167NDA/MAL/HDP/0245CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDEUGLIM 4GLIMEPIRIDE4MGCADILA HEALTHCARE LIMITED -KUNDAIM INDUSTRIAL ESTATE,PLOT NO.203-213, KUNDAIM GOA, 403115, INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2014
168NDA/MAL/HDP/0248IPCA LABORATORIES LTDMEDVIN PHARMA LIMITEDPANTONEX DR-40PANTOPRAZOLE40 MG IPCA LABORATORIES LTD-PLOT NO. 255/1,
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SILVASSA-396230,
DADRA AND NAGAR HAVELI, INDIA.
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169NDA/MAL/HDP/0250PHARMACIE BETHELABACUS PARENTERAL DRUGS LIMITEDDIKONDICLOFENAC1%W/WLINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT INDIATOPICAL EXTERNAL GELS AND SOLS1.0X20.0 G CONTAINER01/07/2013
170NDA/MAL/HDP/0251MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDLAMIVUDINE/ZIDOVUDINE/NEVIRAPINELAMIVUDINE + ZIDOVUDINE + NEVIRAPINE150MG + 300MG + 200MGMACLEODS PHARMACEUTICALS LTD(BLOCK N2)-VILLAGE THEDA,P.O LODHI MAJRA,TEHSIL BADDI,HIMACHAL PRADESH 174101 MACLEODS PHARMACEUTICALS LTD., NO. 25-27-PLOT NO. 25-26-27, SURVEY NO.366, PREMIER INDUSTRIAL ESTATE ., DAMAN - 396210, KACHIGAM, DAMAN INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X60.0 TABLET BOTTLE01/07/2013
171NDA/MAL/HDP/0252LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDVAST-40ATORVASTATIN40MGLINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2014
172NDA/MAL/HDP/0254MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDCONCOR 5BISOPROLOL HEMIFUMARATE5MGMERCK KGAA-250 FRANKFRUTER STRASSE 250-64293 DARMSTADT WINTHROP PHARMACEUTICALS(PTY) LTD,-315 WATLOO ROAD,WATLOO,PRETORIA,SOUTHAFRICA (FPP SECONDARY PACKAGING,FPP RELEASE/QC TESTING SITE) GERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2013
173NDA/MAL/HDP/0255HETERO LABS LTDAIVEEN (U) LIMITEDCAPETERO 150CAPECITABINE150MGHETERO LABS (UNIT VI), INDIA-APIIC, FORMULATION SEZ, POLEPALLY (V),JEDCHERLA(M) MAHABOOBNAGER DISTRICT ANDHRA PRADESH-509301, INDIA. INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X60.0 TABLET CONTAINER01/07/2015
174NDA/MAL/HDP/0256HETERO LABS LTDAIVEEN (U) LIMITEDCAPETERO 500CAPECITABINE500MGHETERO LABS (UNIT VI), INDIA-APIIC, FORMULATION SEZ, POLEPALLY (V),JEDCHERLA(M) MAHABOOBNAGER DISTRICT ANDHRA PRADESH-509301, INDIA. INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X120.0 TABLET CONTAINER01/07/2015
175NDA/MAL/HDP/0257SANOFI AVENTS FRANCELABOREX UGANDA LIMITEDCORDARONEAMIODARONE HYDROCHLORIDE200MGSANOFI WINTHROP INDUSTRIE-LAGRAGE 33565 CARBON BLANC CEDEX FRANCE
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176NDA/MAL/HDP/0261HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDLOSAGEN -100LOSARTAN POTASSIUM100MGHETERO LABS LTD (UNIT-V)-SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2013
177NDA/MAL/HDP/0266ASTRA PHARMA (UK) LTDASTRA PHARMA (U) LIMITEDBENZATHINE PENICILLIN INJECTIONBENZATHINE PENICILLIN2.400.000 IUCSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG)CO. LTD-NO. 88, YANGZI ROAD, SHIJIAZHUANG CITY, HEBEI PROVINCE(WORKSHOP 406 AND 407) CHINAPARENTERAL ORDINARY DRY VIALS1.0X50.0 VIAL CARTON01/07/2001
178NDA/MAL/HDP/0267HETERO LABS LTDAIVEEN (U) LIMITEDPENVIR 750FAMCICLOVIR750MGHETERO LABS LTD (UNIT-V)-SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2013
179NDA/MAL/HDP/0269LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDVOMISTAT-8ONDANSETRON8MGLINCOLN PHARMACEUTICALS LIMITED -10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
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180NDA/MAL/HDP/0270HETERO LABS LTDAIVEEN (U) LIMITEDLEVIN 500MGLEVOFLOXACIN HEMIHYDRATE500MGHETERO LABS LTD (UNIT-V)-SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER01/07/2013
181NDA/MAL/HDP/0271BIOLOGICAL E. LTDGITTOES PHARMACEUTICALS LIMITEDBETTTETANUS VACCNE ADSORBED40 I.UBIOLOGICAL E LTD-PLOT NO.1, S.P BIOTECHNOLOGY PARK, PHASE II KOLTHER (V), SHAMEERPET(M), RANGA REDDY(DIST), ANDHRA PRADESH, INDIA 500078 INDIAPARENTERAL ORDINARY AMPOULES1.0X20.0X10.0 ML AMPOULE,1.0X24.0X10.0 ML AMPOULE,1.0X5.0 ML VIAL (10 DOSES)01/07/2015
182NDA/MAL/HDP/0272HETERO LABS LTDAIVEEN (U) LIMITEDLEVIN 250LEVOFLOXACIN250MGHETERO LABS LTD. UNIT (V)-439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE),
JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA.
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2019
183NDA/MAL/HDP/0275GLAXO SMITHLINE LIMITEDUNITED HEALTHCARE DISTRIBUTORS LTDZENTELALBENDAZOLE400MGGLAXOSMITHKLINE SOUTH AFRICA (PTY) LTD-39 HAWKINS AVENUE, EPPING INDUSTRIAL, CAPE TOWN, 7460, SOUTH AFRICA SOUTH AFRICAORAL SOLID ORDINARY CHEWABLE TABLETS1.0X1.0 TABLET BLISTER01/07/2011
184NDA/MAL/HDP/0276MICRO LABS LTDLABOREX UGANDA LIMITEDMELANOV 80GLICLAZIDE80MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2013
185NDA/MAL/HDP/0278COSMOS LTDASTRA PHARMA (U) LIMITEDCHLORPROMAZINE TABLETS B.P 100MGCHLORPROMAZINE HYDROCHLORIDE100MGCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI KENYAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER01/07/1998
186NDA/MAL/HDP/0283DAWA LIMITEDSUPER MEDIC LTDAMPICLO-DAWAAMPICILLIN + CLOXACILLIN125 MG + 125 MGDAWA PHARMACEUTICALS LIMITED-PLOT 7879, BABA DOGO ROAD RUARAKA KENYAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE01/07/2013
187NDA/MAL/HDP/0284GLAXO SMITHLINE LIMITEDUNITED HEALTHCARE DISTRIBUTORS LTDCLAVULINAMOXICILLIN + CLAVULANIC ACID1000 MG + 200 MGSMITHKLINE BEECHAM PHARMACEUTICALS,-CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QH UNITED KINGDOMPARENTERAL ORDINARY DRY VIALS10.0X1.2 G VIAL01/07/2009
188NDA/MAL/HDP/0286GUILIN PHARMACEUTICAL CO.LTDSTAR PHARMACEUTICALS LTDGLUMACARTEMETHER+LUMEFANTRINE20MG+120MGGUILIN PHARMACEUTICAL CO. LTD-NO. 17 SHANGHAI ROAD, GUILIN 541002, GUANXI CHINA CHINAORAL SOLID ORDINARY TABLETS1.0X24.0 TABLET BLISTER,1.0X6.0 TABLET BLISTER,1.0X18.0 TABLET BLISTER,1.0X12.0 TABLET BLISTER01/07/2014
189NDA/MAL/HDP/0287GOOD DAY PHARMACY LIMITEDPLANET PHARMACEUTICALS UGANDA LTDPOWER HEATMETHYL SALICYLATE15%W/WKREMOINT PHARMA PVT LTD---B-8 ADDITIONAL AMBERNATH MIDC OPP. ANAND NAGAR POLICE CHECK POST AMBERNATH (E) DIST THANE 421 506INDIATOPICAL EXTERNAL CREAMS1.0X25.0 G TUBE,1.0X30.0 G TUBE01/07/2013
190NDA/MAL/HDP/0289ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDTETRASTETRACYCLINE HYDROCHLORIDE250MGASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIA INDIAORAL SOLID ORDINARY CAPSULES1.0X10000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER01/07/1997
191NDA/MAL/HDP/0290LABORATORY AND ALLIED LTDHARLEYS UGANDA LIMITEDNATOAMEBENDAZOLE100MGLABORATORY & ALLIED LTD--PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, MOMBASA ROAD P.O. BOX 42875, GPO 00100, NAIROBI, KENYA KENYAORAL SOLID ORDINARY CHEWABLE TABLETS1.0X1.0X6.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER01/07/1997
192NDA/MAL/HDP/0296COSMOS LTDASTRA PHARMA (U) LIMITEDPRAZITEL TABLETSPRAZIQUANTEL600MGCOSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA KENYAORAL SOLID ORDINARY FILM-COATED TABLETS2.0X10.0 TABLET BLISTER01/07/1998
193NDA/MAL/HDP/0298SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDSEFIXI-50 DRY SYRUPCEFIXIME50MGSAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIA INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X1.0X60.0 ML BOTTLE01/07/2013
194NDA/MAL/HDP/0301HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDMONAST 10MONTELUKAST SODIUM10MGHETERO LABS LTD. UNIT (V)-S.N0.439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE),
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195NDA/MAL/HDP/0303HETERO LABS LTDAIVEEN (U) LIMITEDABACAVIR SULPHATEABACAVIR SULPHATE300MGHETERO DRUGS LTD, UNIT III -22-110, IDA, JEEDIMETLA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X60.0 TABLET CONTAINER01/07/2014
196NDA/MAL/HDP/0304HETERO LABS LTDAIVEEN (U) LIMITEDDARUNAVIRDARUNAVIR400MGHETERO LABS LTD-22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESHINDIAORAL SOLID ORDINARY TABLETS1.0X60.0 TABLET CONTAINER01/07/2014
197NDA/MAL/HDP/0305SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDCEFAX-250 DRY SYRUPCEFALEXIN250MG/5MLSAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIA INDIAORAL LIQUID ORDINARY SOLUBLE POWDERS1.0X1.0X50.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE01/07/2013
198NDA/MAL/HDP/0308SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDCEFAX-250CEFALEXIN250MGSAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIA INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER01/07/2013
199NDA/MAL/HDP/0311MARTINDALE PHARMACEUTICALS LTDLABOREX UGANDA LIMITEDFENTANYLFENTANYL CITRATE50MCG/MLMARTINDALE PHARMACEUTICAL LIMITED -BAMPTON ROAD RMM38UG ENGLANDUNITED KINGDOMPARENTERAL ORDINARY AMPOULES1.0X2.0 ML AMPOULE01/07/2013
200NDA/MAL/HDP/0312SPARSH BIO-TECH PVT LTDABACUS PHARMA (AFRICA) LIMITEDCLOXISPA ORAL SOLUTION 125CLOXACILLIN125MG/5MLSPARSH BIO-TECH LTD-PLOT NO.1 SURVEY NO.242/234/244, VILLAGE LAKHABARAD, JAMNAGAR-361006 INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE01/07/2013
201NDA/MAL/HDP/0314MARTINDALE PHARMACEUTICALS LTDLABOREX UGANDA LIMITEDSUXAMETHONIUM CHLORIDE SOLUTION FOR INJECTIONSUXAMETHONIUM CHLORIDE50MG/MLMARTINDALE PHARMA -BAMPTON ROAD, HAROLD HILL,ROMFORD,RM3844 UNITED KINGDOMPARENTERAL ORDINARY AMPOULES1.0X10.0X2.0 ML AMPOULE01/07/2013
202NDA/MAL/HDP/0318DAWA LIMITEDSUPER MEDIC LTDSABULINSALBUTAMOL4MGDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2013
203NDA/MAL/HDP/0320DAWA LIMITEDSUPER MEDIC LTDDAZOLECLOTRIMAZOLE1%W/WDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYATOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE01/07/2013
204NDA/MAL/HDP/0322MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDNEBILONG-5NEBIVOLOL HCL5MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2009
205NDA/MAL/HDP/0326ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDOSTEBONCALCIUM + COLECALCIFEROL250MG + 125 IUARISTO PHARMACEUTICALS PVT LIMITED-PLOT 208, NEW INDUSTRIAL AREA NO II, MANDIDEEP-462 046 (DISTRICT) RAISEN, MADHYA PRADESH INDIA INDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X200.0 ML BOTTLE01/07/2014
206NDA/MAL/HDP/0330ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDASBUTOL-4SALBUTAMOL4MGASTRA LIFECARE (INDIA) PVT. LTD-PLOT 57/P, SARKHEJ-BAVLA HIGHWAY, RAJODA 382 220, AHMEDABAD, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2013
207NDA/MAL/HDP/0332ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDROSUVAX 20ROSUVASTATIN CALCIUM20MGASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X15.0 TABLET BLISTER01/07/2015
208NDA/MAL/HDP/0333KOPRAN LIMITEDTATA UGANDA LIMITEDCLAVAMYN-625AMOXICILLIN TRIHYDRATE + POTASSIUM CLAVULANATE500MG +125MGKOPRAN LIMITED-VILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER01/07/2014
209NDA/MAL/HDP/0334ABOTT LABORATORIES S.A (PTY) LIMITEDHARLEYS UGANDA LIMITEDTARKA 180/2VERAPAMIL HYDROCHLORIDE + TRANDOLAPRIL180MG+3MGABOTT GMBH & CO KG -KNOLLSTRASSE 67061 LUDWIGSHAFENGERMANYORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2013
210NDA/MAL/HDP/0335GOOD DAY PHARMACY LIMITEDPLANET PHARMACEUTICALS UGANDA LTDNEOMYCIN SULPHATE CREAM USPNEOMYCIN SULPHATE CREAM USP0.5%WWKREMOINT PHARMA PVT LTD-B-8,ADDITIONAL AMBERNATH MIDC, AMBERNATH (E),DIST: THANE 421506, INDIA INDIATOPICAL EXTERNAL CREAMS1.0X1.0X30.0 G TUBE01/07/2013
211NDA/MAL/HDP/0336ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDAS-DP TABLETSDICYCLOMINE HCL + PARACETAMOL20MG+500MGASTRA LIFECARE (INDIA) PVT. LTD-PLOT 57/P, SARKHEJ-BAVLA HIGHWAY, RAJODA 382 220, AHMEDABAD, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET STRIP01/07/2013
212NDA/MAL/HDP/0337IND-SWIFTPLANET PHARMACEUTICALS UGANDA LTDSWAZI *500AZITHROMYCIN500MGIND SWIFT LTD-GLOBAL BUSINESS UNIT JAWAHARPUR OFF NH-21 DERABASSI DIST MOHALI PUNJAB 140507INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0 TABLET BLISTER01/07/2014
213NDA/MAL/HDP/0338KOPRAN LIMITEDTATA UGANDA LIMITEDKORAB 20RABEPRAZOLE SODIUM20MGKOPRAN LIMITED-VILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER01/07/2013
214NDA/MAL/HDP/0339IND-SWIFTPLANET PHARMACEUTICALS UGANDA LTDSWAZI *250AZITHROMYCIN250MGIND SWIFT LTD-GLOBAL BUSINESS UNIT JAWAHARPUR OFF NH-21 DERABASSI DIST MOHALI PUNJAB 140507INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X6.0 TABLET BLISTER01/07/2014
215NDA/MAL/HDP/0340GOOD DAY PHARMACY LIMITEDPLANET PHARMACEUTICALS UGANDA LTDSONADAYCLOBETASOL-17-BUTYRATE + GENTAMYCIN SULPHATE + MICONAZOLE NITRATE0.05%W/W+0.1%W/W+2%W/WKREMOINT PHARMA PVT LTD---B-8 ADDITIONAL AMBERNATH MIDC OPP. ANAND NAGAR POLICE CHECK POST AMBERNATH (E) DIST THANE 421 506INDIATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE01/07/2013
216NDA/MAL/HDP/0341IND SWIFT LTDPLANET PHARMACEUTICALS UGANDA LTDTELSWIFT- H 40TELMISARTAN + HYDROCHLOROTHIAZIDE40MG + 12.5MGIND SWIFT LTD-GLOBAL BUSINESS UNIT JAWAHARPUR OFF NH-21 DERABASSI DIST MOHALI PUNJAB 140507INDIAORAL SOLID ORDINARY TABLETS1.0X4.0X10.0 TABLET BLISTER01/07/2014
217NDA/MAL/HDP/0342IND SWIFT LTDPLANET PHARMACEUTICALS UGANDA LTDTELSWIFT- H 80TELMISARTAN + HYDROCHLOROTHIAZIDE80MG + 12.5MGIND SWIFT LTD-GLOBAL BUSINESS UNIT JAWAHARPUR OFF NH-21 DERABASSI DIST MOHALI PUNJAB 140507INDIAORAL SOLID ORDINARY TABLETS1.0X4.0X7.0 TABLET BLISTER01/07/2014
218NDA/MAL/HDP/0343GOOD DAY PHARMACY LIMITEDPLANET PHARMACEUTICALS UGANDA LTDWHITFIELD'S OINTMENT B.PBENZOIC ACID + SALICYLIC ACID6% W/W + 3% W/WKREMOINT PHARMA PVT LTD---B-8 ADDITIONAL AMBERNATH MIDC OPP. ANAND NAGAR POLICE CHECK POST AMBERNATH (E) DIST THANE 421 506INDIATOPICAL EXTERNAL OINTMENTS1.0X25.0 G TUBE01/07/2013
219NDA/MAL/HDP/0348PHARMACIE BETHELABACUS PARENTERAL DRUGS LIMITEDXBETABETAMETHASONE SODIUM PHOSPHATE0.1%W/VABACUS PARENTERAL DRUGS LIMITED-BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA. UGANDAOPHTHALMIC DROPS1.0X10.0 ML VIAL01/07/2015
220NDA/MAL/HDP/0349SWISS PARENTERALS PVT LTDSHREEJI PHARMACEUTICALS LIMITEDCLAXY 1.2 GCOAMOXICLAV1.2GSWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIAINDIAPARENTERAL ORDINARY DRY VIALS1.0X1.2 G VIAL01/07/2013
221NDA/MAL/HDP/0350RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDCETRIRENCETIRIZINE HYDROCHLORIDE10MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA UGANDAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2015
222NDA/MAL/HDP/0351MANKIND PHARM LTDTATA UGANDA LIMITEDDEPREGDINALEVONORGESTREL1.5MGACME FORMULATION PVT LTD.-ROPAR ROAD, NALAGARH, DIST. SOLAN, HIMACHAL PRADESH 174101 INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X1.0 TABLET BLISTER01/07/2014
223NDA/MAL/HDP/0353HOVID BHDUNITED HEALTHCARE DISTRIBUTORS LTDDEROX-10AMLODIPINE BESILATE10MGHOVID BHD -121 ,JALAN TUNKU ABDUL RAHMAN , 30010 IPOH , PERAK , MALAYSIA MALAYSIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X3.0X1.0X10.0 TABLET BLISTER01/07/2015
224NDA/MAL/HDP/0354KOPRAN LIMITEDTATA UGANDA LIMITEDLEVOKOPLEVOFLOXACIN500MGKOPRAN LIMITED-VILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER01/07/2013
225NDA/MAL/HDP/0355SWISS PARENTERALS PVT. LTD.SHREEJI PHARMACEUTICALS LIMITEDBICO VITATHIAMINE HCL + RIBOFLAVIN + PYRIDOXINE HCL + NICOTINAMIDE10MG + 0.1MG + 1MG + 10MGSWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIAINDIAPARENTERAL ORDINARY AMPOULES1.0X10.0X2.0 ML AMPOULE01/07/2015
226NDA/MAL/HDP/0356DENK PHARMA GMBH & CO KGBENLE CONSULT LIMITEDLEVO DENK 50OLEVOFLOXACIN HEMIHYDRATE500MGROTTENDORF PHARMA GMBH-OSTENFELDER STRASSE 51-61 59320 ENNIGERLOH GERMANYGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X5.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER01/07/2014
227NDA/MAL/HDP/0358SWISS PARENTERALS PVT LTDSHREEJI PHARMACEUTICALS LIMITEDSTREPTOCINSTREPTOMYCIN SULPHATE1GMSWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIAINDIAPARENTERAL ORDINARY I M VIALS1.0X1.0 G VIAL01/07/2014
228NDA/MAL/HDP/0360ASTRA ZENECA ABMACNAUGHTON LIMITEDNEXIUM 20MGESOMEPRAZOLE20MGASTRA ZENECA AB, SODERTALJE-GARTUNAYEGEN, SODERTALJE SWEDENORAL SOLID ORDINARY TABLETS1.0X4.0X7.0 TABLET BLISTER,1.0X7.0 TABLET BLISTER,1.0X14.0 TABLET CARTON01/07/2001
229NDA/MAL/HDP/0362SWISS PARENTERALS PVT. LTD.SHREEJI PHARMACEUTICALS LIMITEDBUPIBUPIVACAINE5 MG/MLSWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIAINDIAPARENTERAL ORDINARY VIALS1.0X20.0 ML VIAL01/07/2015
230NDA/MAL/HDP/0363BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDAGYCINAZITHROMYCIN250MGBLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X6.0 TABLET BLISTER01/07/2014
231NDA/MAL/HDP/0365UNIVERSAL CORPORATION LTDHARLEYS UGANDA LIMITEDSULFRAN- DSTRIMETHOPRIM/SULFAMETHOXAZOLE160MG/800MGUNIVERSAL CORPORATION LIMITED -PLOT 13777 KIKUYU ROAD, KIKUYU TOWN, PAST POST OFFICE KENYAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER01/07/2015
232NDA/MAL/HDP/0366BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDAGYCIN 500AZITHROMYCIN500MGBLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0 TABLET BLISTER01/07/2014
233NDA/MAL/HDP/0367BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDBG-ZOLE -400ALBENDAZOLE400MGBLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIAINDIAORAL SOLID ORDINARY CHEWABLE TABLETS1.0X1.0 TABLET BLISTER01/07/2013
234NDA/MAL/HDP/0368ROTEX MEDICA GBH ARZNEIMITTELIGITTOES PHARMACEUTICALS LIMITEDQUININE DI HYDROCHLORIDE INJECTIONQUININE DIHYDROCHLORIDE300MG/MLROTEXMEDICA GMBH ARZEIMITTEL WERK-BUNSENSTRASSE 4, 22946 TRITTAU CHINAPARENTERAL ORDINARY AMPOULES1.0X10.0X2.0 ML AMPOULE01/07/1997
235NDA/MAL/HDP/0369ABBOT LABORATORIES S.A. (PTY) LTDHARLEYS UGANDA LIMITEDKLACID 250MGCLARITHROMYCIN250MGABBOTT LABORATORIES S.A (PTY) LTD-ABBOTT PLACE,219 GOLF CLUB
TERRACE,CONSTANTIA KLOOF 1709 P.O BOX 7208 WELTEVREDENPARK 1715
SOUTH AFRICAORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER01/07/1998
236NDA/MAL/HDP/0370MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDNEBILONG-HNEBIVOLOL + HYDROCHLOROTHIAZIDE5MG + 12.5MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2010
237NDA/MAL/HDP/0372UNICHEM LABORATORIES LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDLEZYNCETLEVOCETIRIZINE5MGUNICHEM LABORATORIES LIMITED-UNICHEM LABORATORIES LIMITED. UNIT II, VILLAGE BHATAULI KALAN, BADDI, DIST. SOLAN PIN CODE 173 205, HIMACHAL PRADESH, INDIA

INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X10.0 TABLET BLISTER,5.0X2.0X10.0 TABLET BLISTER01/07/2009
238NDA/MAL/HDP/0373MEDOCHEMIE LTDBOOTS PHARMACEUTICALS LIMITEDTEMELINCETIRIZINE HYDROCHLORIDE10MGMEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY.-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA CYPRUSORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2013
239NDA/MAL/HDP/0375MEDOCHEMIE LTDBOOTS PHARMACEUTICALS LIMITEDFENAMON SRNIFEDIPINE20MGMEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY.-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA CYPRUSORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X10.0 TABLET BLISTER01/07/2014
240NDA/MAL/HDP/0376EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDASOMEX-DAMLODIPINE + HYDROCHLOROTHIAZIDE2.5 MG + 12.5 MGEMCURE PHARMACEUTICALS LTD-LANE NO.3 PHASE II SIDCO INDUSTRIAL COMPLEX BARI BRAHMANA JAMMU (J&K) 18113INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2014
241NDA/MAL/HDP/0377MEDOCHEMIE LTDBOOTS PHARMACEUTICALS LIMITEDDUINUMCLOMIFENE50MGMEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY.-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA CYPRUSORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER01/07/2014
242NDA/MAL/HDP/0380MEDOCHEMIE LTDBOOTS PHARMACEUTICALS LIMITEDAVERNOLCARVEDILOL6.25NGMEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY.-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA CYPRUSORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2014
243NDA/MAL/HDP/0381MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDEFAVIRENZ/EMTRICITABINE/TENOFOVIREFAVIRENZ + EMTRICITABINE + TENOFOVIR600MG + 200MG + 300MGMACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET BOTTLE01/07/2013
244NDA/MAL/HDP/0385ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDASFORMINMETFORMIN HYDROCHLORIDE500MGASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2015
245NDA/MAL/HDP/0386EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDLOMOH-80ENOXAPARIN SODIUM80MG/ 0.8MLEMCURE PHARMACEUTICALS LTD -PLOT NO. P-1 ITBT PARK PHASE II MIDC HINJWADI PUNE 411057INDIAPARENTERAL ORDINARY PRE-FILLED SYRINGES1.0X1.0 ML PRE- FILLED SYRINGE01/07/2014
246NDA/MAL/HDP/0388KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDAZUCLOXAMPICILLIN + CLOXACILLIN250 MG + 250 MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALAUGANDAORAL SOLID ORDINARY CAPSULES1.0X10.0 CAPSULE STRIP,1.0X250.0 CAPSULE CONTAINER,1.0X1000.0 CAPSULE CONTAINER,1.0X500.0 CAPSULE CONTAINER,1.0X100.0X10.0 CAPSULE BLISTER01/07/1997
247NDA/MAL/HDP/0389PT SANBE FARMAMEDVIN PHARMA LIMITEDSANMOL INFUSION IVPARACETAMOL1000MG/100MLPT SANBE FARMA JI INDUSTRI-NO.8 KOMPLEKS INDUSTRI CIMAREME PADALARANG BANDUNGINDONESIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X100.0 ML BOTTLE01/07/2014
248NDA/MAL/HDP/0393NAARI LTDECHO PHARMACY (U) LIMITEDMISO-KAREMISOPROSTOL200MCGNAARI PHARMA PRIVATE LIMITED-PLOT NO. 14-16, 55-57, SECTOR-5, IIE, PANT NAGAR RUDRAPUR-263153 DIST-U.S. NAGAR UTTARAKHAND INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X4.0 TABLET BLISTER01/07/2013
249NDA/MAL/HDP/0394LEBEN LABORATORIES PVT.LTDANDYCO PHARMACY (UGANDA) LTDDOXYLEBDOXYCYCLINE100MGLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER01/07/2014
250NDA/MAL/HDP/0397EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDASOMEX-LTAMLODIPINE + LOSARTAN POTASSIUM2.5 MG + 50 MGEMCURE PHARMACEUTICALS LTD-LANE NO.3 PHASE II SIDCO INDUSTRIAL COMPLEX BARI BRAHMANA JAMMU (J&K) 18113INDIAORAL SOLID ORDINARY TABLETS1.0X2.0X3.0X10.0 TABLET BLISTER01/07/2013
251NDA/MAL/HDP/0400CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDIBSOL 1.2MESALAMINE DELAYED RELEASE1.2GMCADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA INDIAORAL SOLID RETARD FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2013
252NDA/MAL/HDP/0402IVEE AQUA EPZ LTDASTRA PHARMA (U) LIMITEDIVYSONE OPHTHALMIC SUSPENSIONHYDROCORTISONE ACETATE1%W/VIVEE INFUSIONS EPZ LTD--LR NO.18474/84,ATHI RIVER BOX 25251 00100 NAIROBI KENYA ATHI RIVER,KENYA KENYAOPHTHALMIC SUSPENSIONS5.0 ML VIAL01/07/2000
253NDA/MAL/HDP/0403NEON LABARATORIES LTDAIVEEN (U) LIMITEDSUPRIDOLTRAMADOL HYDROCHLORIDE50MG/MLNEON LABORATORIES LTD --PLOT NO. 29, 30, 31, 32, 57 & 60, THE PALGHAR TALUKA - CO-OP ESTATE LTD., BOISAR ROAD, PALGHAR, DIST - THANE - 401404, MAHARASHTRA INDIAPARENTERAL ORDINARY I V AMPOULES1.0X2.0X5.0X1.0 ML AMPOULE01/07/2013
254NDA/MAL/HDP/0404GLAXOSMITH KLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDACTIFED WET COUGH & COLDTRIPLORIDINE HCL/PSEUDOEPHEDRINE/GUAIPHENESIN1.25MG/30MG/100MGGLAXO WELLCOME EGYPT SAE.-EL SALAM CITY 11491, CAIRO EGYPTORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE,1.0X2.0 L JERRYCAN01/07/1997
255NDA/MAL/HDP/0405NEON LABARATORIES LTDAIVEEN (U) LIMITEDCHEMLETLETROZOLE2.5MGNEON LABORATORIES LTD-PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROAD INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2013
256NDA/MAL/HDP/0406NEON LABARATORIES LTDAIVEEN (U) LIMITEDEVATOCINOXYTOCIN10 I.U./ MLNEON LABORATORIES LTD-PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROAD INDIAPARENTERAL ORDINARY I V AMPOULES1.0X2.0X5.0X1.0 ML AMPOULE01/07/2015
257NDA/MAL/HDP/0407NEON LABARATORIES LTDAIVEEN (U) LIMITEDNEOROFPROPOFOL1%W/VNEON LABORATORIES LTD --PLOT NO. 29, 30, 31, 32, 57 & 60, THE PALGHAR TALUKA - CO-OP ESTATE LTD., BOISAR ROAD, PALGHAR, DIST - THANE - 401404, MAHARASHTRA INDIAPARENTERAL ORDINARY I V AMPOULES1.0X20.0 ML AMPOULE01/07/2013
258NDA/MAL/HDP/0408MSN LABORATORIES LTDMETRO PHARMACEUTICALS LIMITEDALGIC - PACECLOFENAC + PARACETAMOL100 MG + 500 MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2013
259NDA/MAL/HDP/0409NEON LABARATORIES LTDAIVEEN (U) LIMITEDTYDE-S*CHLORAMPHENICOL SODIUM SUCCINATE1G/VIALNEON LABORATORIES LTD --PLOT NO. 29, 30, 31, 32, 57 & 60, THE PALGHAR TALUKA - CO-OP ESTATE LTD., BOISAR ROAD, PALGHAR, DIST - THANE - 401404, MAHARASHTRA INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0 G VIAL01/07/2013
260NDA/MAL/HDP/0410MSN LABORATORIES LTDPLANET PHARMACEUTICALS UGANDA LTDLDNIL 20ROSUVASTATIN CALCIUM20MGMSN LABORATORIES LTD- PLOT N0.42, ANRICH INDUSTRIAL ESTATE INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2013
261NDA/MAL/HDP/0411BAYER PHARMA AGSURGIPHARM (U) LIMITEDJADELLE SINELEVONORGESTREL150MGBAYER OY-PANSIONATE 47 20210 TURKU FINLANDFINLANDPARENTERAL RETARD IMPLANTS1.0X10.0X1.0X2.0X75.0 MG IMPLANT01/07/2003
262NDA/MAL/HDP/0412MSN LABORATORIES LTDPLANET PHARMACEUTICALS UGANDA LTDLDNIL 5ROSUVASTATIN CALCIUM5MGMSN LABORATORIES LTD- PLOT N0.42, ANRICH INDUSTRIAL ESTATE INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2013
263NDA/MAL/HDP/0413NEON LABARATORIES LTDAIVEEN (U) LIMITEDXSPASHYOSCINE BUTYLBROMIDE20MG/MLNEON LABORATORIES LTD --PLOT NO. 29, 30, 31, 32, 57 & 60, THE PALGHAR TALUKA - CO-OP ESTATE LTD., BOISAR ROAD, PALGHAR, DIST - THANE - 401404, MAHARASHTRA INDIAPARENTERAL ORDINARY I V AMPOULES1.0X2.0X5.0X1.0 ML AMPOULE01/07/2013
264NDA/MAL/HDP/0415MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDRELEXDIPHENHYDRAMINE HYDROCHLORIDE+AMMONIUM CHLORIDE+SODIUM CITRATE+MENTHOL14.03MG+138MG+57.03MG+0.90MGTORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506INDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE01/07/1997
265NDA/MAL/HDP/0416NOVARTIS PHARMA SERVICES INC.SURGIPHARM (U) LIMITEDRAMIZID 5RAMIPRIL5MGLEK S.A-95 - 010 STRYKÓW, PODLIPIE 16, POLAND POLANDORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2014
266NDA/MAL/HDP/0418ASTRA ZENECAMACNAUGHTON LIMITEDKOMBIGLYZE XR 5MG/1000SAXAGLIPTIN + METFORMIN5MG + 1000MGASTRAZENECA PHARMACEUTICALS LP.-4601 HIGHWAY 62 EAST MOUNT VERNON INDIANA 47620 USAUNITED STATESORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET BOTTLE01/07/2013
267NDA/MAL/HDP/0419ASTRAZENECAMACNAUGHTON LIMITEDKOMBIGLYZE XR 2.5MG/1000MGSAXAGLIPTIN + METFORMIN2.5MG + 1000MGASTRAZENECA PHARMACEUTICALS LP.-4601 HIGHWAY 62 EAST MOUNT VERNON INDIANA 47620 USAUNITED STATESORAL SOLID ORDINARY TABLETS1.0X60.0 TABLET BOTTLE01/07/2013
268NDA/MAL/HDP/0421MSN LABORATORIES LTDMETRO PHARMACEUTICALS LIMITEDPREGASAFE 150PREGABALIN150MGMSN LABORATORIES LTD-PLOT NO.42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, INDIA INDIAORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER01/07/2014
269NDA/MAL/HDP/0422AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDPARAFLAMIBUPROFEN + PARACETAMOL100MG + 162.5MG /5MLAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE01/07/2013
270NDA/MAL/HDP/0423AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOTRAMTRAMADOL50MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0X10.0 CAPSULE BLISTER01/07/2013
271NDA/MAL/HDP/0424COSMOS LTDASTRA PHARMA (U) LIMITEDCHLORPROMAZINE TABLETS B.P 25MGCHLORPROMAZINE25MGCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI KENYAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER01/07/1998
272NDA/MAL/HDP/0426HETERO LABS LTDAIVEEN (U) LIMITEDLAMIVUDINE + ZIDOVUDINE + NEVIRAPINELAMIVUDINE + ZIDOVUDINE + NEVIRAPINE150MG +300MG + 200MGHETERO LABS LIMITED (UNIT III)...-22-110, I.D.A, JEEDIMETLA, HYDERABAD-500 055, ANDHRA PRADESH, INDIA HETERO LABS LIMITED (UNIT V)-SY NO. 436,440, 441 & 458, APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M), MAHABOOBNAGAR, DISTRICT ANDHRA PRADESH 509301 INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X60.0 TABLET CONTAINER01/07/2013
273NDA/MAL/HDP/0427MICRO LABS LTDLABOREX UGANDA LIMITEDAMLOZAAR -HLOSARTAN POTASSIUM + AMLODIPINE BESILATE + HYDROCHLOROTHIAZIDE50MG + 5MG + 12.5MGMICRO LABS LTD ..-57, SIPCOT INDUSTRIAL COMPLEX, HOSUR-635126, TAMIIL NADU INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2015
274NDA/MAL/HDP/0428MICRO LABS LTDLABOREX UGANDA LIMITEDMICROMOX-400MOXIFLOXACIN400MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X5.0 TABLET BLISTER01/07/2013
275NDA/MAL/HDP/0429ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDFLEXON MRIBUPROFEN + PARACETAMOL + CHLORZOXAZONE400MG + 325MG + 250MGARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO. II, MANDIDEEP-462046, DIST. - RAISEN, MADHYA PRADESH, INDIA. INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2014
276NDA/MAL/HDP/0430ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDARISTO ACECLO PLUSACECLOFENAC+PARACETAMOL100MG+500MGARISTO PHARMACEUTICALS PVT LIMITED-PLOT 208, NEW INDUSTRIAL AREA NO II, MANDIDEEP-462 046 (DISTRICT) RAISEN, MADHYA PRADESH INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X15.0X10.0 TABLET BLISTER01/07/2013
277NDA/MAL/HDP/0433PT SAMBE FARMAMEDVIN PHARMA LIMITEDPROANES MCT/LCTPROPOFOL1%W/VPT SANBE FARMA JI INDUSTRI-NO.8 KOMPLEKS INDUSTRI CIMAREME PADALARANG BANDUNGINDONESIAPARENTERAL ORDINARY I V AMPOULES1.0X5.0X20.0 ML AMPOULE01/07/2014
278NDA/MAL/HDP/0434LEBEN LABORATORIES PVT LTDANDYCO PHARMACY (UGANDA) LTDPROHIBINOMEPRAZOLE20MGLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE STRIP01/07/2010
279NDA/MAL/HDP/0436PT SANBE FARMAMEDVIN PHARMA LIMITEDSANBE HEST 130POLY (0-2-HYDROXYETHYL) STARCH30GPT SANBE FARMA-JI LEUIGAJAH NO. 162 CIMINDI, INDONESIA INDONESIAPARENTERAL ORDINARY INFUSION BAGS1.0X500.0 ML BOTTLE01/07/2014
280NDA/MAL/HDP/0438PT SANBE FARMAMEDVIN PHARMA LIMITEDSANBE HEST 200POLY (0-2-HYDROXYETHYL) STARCHMW 200,000PT SANBE FARMA-JI LEUIGAJAH NO. 162 CIMINDI, INDONESIA INDONESIAPARENTERAL ORDINARY INFUSION BAGS1.0X500.0 ML BOTTLE01/07/2014
281NDA/MAL/HDP/0440AGIO PHARMACEUTICALS LTDROYAL PHARMA 2011 LIMITEDAGICLOB-GMCLOBETASOL/GENTAMICIN/MICONAZOLE0.5MG+3.4MG+20MG/1GAGIO PHARMACEUTICALS LTD-PLOT NO. T-81, 82 MIDC, BHOSARI, PUNE-26 INDIATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE01/07/2014
282NDA/MAL/HDP/0441AGIO PHARMACEUTICALS LTDROYAL PHARMA 2011 LIMITEDAGISECSECNIDAZOLE1GMAGIO PHARMACEUTICALS LTD-PLOT NO. T-81, 82 MIDC, BHOSARI, PUNE-26 INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0 TABLET BLISTER01/07/2015
283NDA/MAL/HDP/0445AGIO PHARMACEUTICALS LTDROYAL PHARMA 2011 LIMITEDAZIAGIO 500AZITHROMYCIN500MGAGIO PHARMACEUTICALS LTD-PLOT NO. T-81, 82 MIDC, BHOSARI, PUNE-26 INDIAORAL SOLID ORDINARY TABLETS1.0X3.0 TABLET BLISTER01/07/2014
284NDA/MAL/HDP/0449PHILLIPS PHARMACEUTICALS LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDAMINOGUARD GRANULESCYANOCOBALAMIN5MCGSTEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA INDIAORAL SOLID ORDINARY GRANULES1.0X10.0X5.0 G SACHET01/07/2013
285NDA/MAL/HDP/0453PHILLIPS PHARMACEUTICALS LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDAMINOGUARD LIQUIDAMINO ACIDS + MULTIVITAMINSMULTI INGREDIENTSSTEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA INDIAORAL LIQUID ORDINARY LIQUIDS1.0X200.0 ML BOTTLE01/07/2013
286NDA/MAL/HDP/0454PT SANBE FARMAMEDVIN PHARMA LIMITEDLEVOCIN INFUSIONLEVOFLOXACIN HEMIHYDRATE500 MGPT SANBE FARMA JI INDUSTRI-NO.8 KOMPLEKS INDUSTRI CIMAREME PADALARANG BANDUNGINDONESIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X100.0 ML BOTTLE01/07/2014
287NDA/MAL/HDP/0456LEBEN LABORATORIES PVT. LTDANDYCO PHARMACY (UGANDA) LTDMETROLEBMETRONIDAZOLE125MG/5MLLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE01/07/2014
288NDA/MAL/HDP/0457UNIVERSAL CORPORATION LTDDELMAW ENTERPRISES LIMITEDUNIBROL 250MGAMINOSIDINE250MGUNIVERSAL CORPORATION LTD-UNIVERSAL CORPORATION LTDKENYAORAL SOLID ORDINARY TABLETS1.0X2.0X6.0 TABLET BLISTER,1.0X4.0X6.0 TABLET BLISTER01/07/2012
289NDA/MAL/HDP/0460ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDAMBRODILAMBROXOL HYDROCHLORIDE7.5MG/MLARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO.II,MANDIDEEEP PRADESH INDIAORAL LIQUID ORDINARY LIQUIDS1.0X15.0 ML BOTTLE01/07/2009
290NDA/MAL/HDP/0461BEXIMCO PHARMACEUTICALS LTDKIMSY MEDS LTDBEXITROL-F HFA 25/125SALMETEROL XINAFOATE + FLUTICASONE PROPIONATE25MCG+125MCGBEXIMCO PHARMACEUTICALS LTD-TONGI- 1711, GAZIPUR, BANGLADESH BANGLADESHTOPICAL EXTERNAL METERED-DOSE PRESSURISED AEROSOLS1.0X120.0 METERED DOSE CANNISTER01/07/2015
291NDA/MAL/HDP/0462BEXIMCO PHARMACEUTICALS LTDKIMSY MEDS LTDDECOMIT 50 HFABECLOMETHASONE50MCGBEXIMCO PHARMACEUTICALS LTD-TONGI- 1711, GAZIPUR, BANGLADESH BANGLADESHTOPICAL EXTERNAL METERED-DOSE PRESSURISED AEROSOLS1.0X200.0 METERED DOSE CANNISTER01/07/2015
292NDA/MAL/HDP/0463AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDTOPHENPHENYTOIN100MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0 CAPSULE CONTAINER,1.0X100.0X10.0 CAPSULE BLISTER01/07/2011
293NDA/MAL/HDP/0465BEXIMCO PHARMACEUTICALS LTDKIMSY MEDS LTDDECOMIT 100 HFABECLOMETHASONE DIPROPIONATE200MCGBEXIMCO PHARMACEUTICALS LTD-TONGI- 1711, GAZIPUR, BANGLADESH BANGLADESHTOPICAL EXTERNAL METERED-DOSE PRESSURISED AEROSOLS1.0X200.0 METERED DOSE CANNISTER01/07/2015
294NDA/MAL/HDP/0466BEXIMCO PHARMACEUTICALS LTDKIMSY MEDS LTDALPHIN DSALBENDAZOLE400MGBEXIMCO PHARMACEUTICALS LTD-TONGI- 1711, GAZIPUR, BANGLADESH BANGLADESHORAL SOLID ORDINARY CHEWABLE TABLETS1.0X50.0 TABLET BLISTER,1.0X50.0X1.0 TABLET BLISTER01/07/2015
295NDA/MAL/HDP/0467DAWA PHARMACEUTICALS LIMITEDSUPER MEDIC LTDCURAMOL PLUSPARACETAMOL/CAFFEINE500MG/60MGDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYAORAL SOLID ORDINARY TABLETS50.0X2.0 TABLET STRIP01/07/1997
296NDA/MAL/HDP/0468NECTAR LIFESCIENCES LTDAIVEEN (U) LIMITEDCEFUAXIT 750CEFUROXIME750MGNECTAR LIFESCIENCES LIMITED-VILL. BHATOLIKALAN, ADJOININGJHARMJRI,
P.O BAROTIWALA DIST SOLAN H.P 173205
INDIAPARENTERAL ORDINARY DRY VIALS1.0X750.0 MG VIAL + 10ML WFI AMPOULE01/07/2013
297NDA/MAL/HDP/0470NOVO NORDISK PHARMA GULF FZ-LCPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDNOVOMIX 30 FLEXPENINSULIN ASPART100I.U/MLNOVO NORDISK A/S - NOVO ALLE DK-2880 BAGSVAERDDENMARKPARENTERAL ORDINARY DRY PRE-FILLED PENS1.0X5.0X3.0 ML PREFILLED PEN01/07/2014
298NDA/MAL/HDP/0471NOVO NORDISK PHARMA GULF FZ-LCPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDNOVORAPID FLEXPENINSULIN ASPART100 I.U/MLNOVO NORDISK A/S - NOVO ALLE DK-2880 BAGSVAERDDENMARKPARENTERAL ORDINARY PRE-FILLED PENS1.0X5.0X3.0 ML PREFILLED PEN01/07/2014
299NDA/MAL/HDP/0472SERUM INSTITUTE OF INDIA LTD.NORVIK ENTERPRISES LIMITEDBCG VACCINE (FREEZE DRIED)BCG VACCINE(FREEZE DRIED)1.33*100000 C.F.U/0.1MLSERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIA INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0 ML VIAL,1.0X0.5 ML VIAL01/07/2015
300NDA/MAL/HDP/0475LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDTINI-500TINIDAZOLE500MGLINCOLN PHARMACEUTICALS LIMITED -10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X25.0X4.0 TABLET BLISTER01/07/2015
301NDA/MAL/HDP/0477LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDVOMISTAT-4ONDANSETRON4MGLINCOLN PHARMACEUTICALS LIMITED -10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2014
302NDA/MAL/HDP/0480CIPLA LTDQUALITY CHEMICALS LTD - HUMANEFAVIRENZ, LAMIVUDINE & TENOFOVIR DISOPROXIL FUMERATE 600/300/300 MGEFAVIRENZ + LAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE600MG+300MG+300MGCIPLA QUALITY CHEMICAL INDUSTRIES LIMITED - -PLOT 1-7 1ST RING ROAD, LUZIRA, KAMPALA CIPLA L.T.D -MIDC PATALGANGA MAHARASHTRA 410 220 CIPLA LTD UNIT VII PD II-S-103 TO S-105, S-107 TO S-112, L-138, L-147/1 TO L-147/3, L-147A, VERNA INDUSTRIAL ESTATE, VERNA SALCETTE, GOA 403722, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X30.0 TABLET CONTAINER01/07/2014
303NDA/MAL/HDP/0482LEBEN LABORATORIES PVT. LTD., INDIAANDYCO PHARMACY (UGANDA) LTDAZILEB-500AZITHROMYCIN500MGLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X20.0X3.0 TABLET BLISTER01/07/2014
304NDA/MAL/HDP/0483FOUNTIL LIFE SCIENCES PVT LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDULGICID TABLETSALGINIC ACID+ MAGNESIUM HYDROXIDE+ ALUMINIUM HYDROXIDE+ MAGNESIUM TRISILICATE + SIMETICONE200MG + 250MG + 250MG + 250MG + 125MGSTEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA INDIAORAL SOLID ORDINARY CHEWABLE TABLETS1.0X3.0X10.0 TABLET STRIP01/07/2013
305NDA/MAL/HDP/0484KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDPILPLAN PLUSETHINYL ESTRADIOL + LEVONORGESTREL / FERROUS FUMARATE0.03MG+0.15MG/75MGBAYER SCHERING PHARMA AG.-13342, BERLIN GERMANYORAL SOLID ORDINARY TABLETS1.0X10.0X3.0X28.0 TABLET BLISTER01/07/2014
306NDA/MAL/HDP/0489LEBEN LABORATORIES PVT.LTDANDYCO PHARMACY (UGANDA) LTDCEBAY-200 DTCEFIXIME200MGLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL SOLID ORDINARY SOLUBLE TABLETS1.0X10.0 TABLET BLISTER01/07/2014
307NDA/MAL/HDP/0490SANOFILABOREX UGANDA LIMITEDORELOXCEFPODOXIME200MGSANOFI WINTHROP INDUSTRIE-SANOFI WINTHROP INDUSTRIE
56, RUE DE CHOISY AU BAC
60205 COMPIÈGNE
FRANCEORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER01/07/2013
308NDA/MAL/HDP/0491PHARMACIE BETHELABACUS PARENTERAL DRUGS LIMITEDABCHLOR EYE DROPSCHLORAMPHENICOL0.5% W/VABACUS PARENTERAL DRUGS LTD-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE,
MUKONO
UGANDAOPHTHALMIC DROPS1.0X5.0 ML VIAL,1.0X10.0 ML VIAL01/07/2013
309NDA/MAL/HDP/0492BEXIMCO PHARMACEUTICALS LTDKIMSY MEDS LTDZOLFINACECLOFENAC100MGBEXIMCO PHARMACEUTICALS LTD-TONGI- 1711, GAZIPUR, BANGLADESH BANGLADESHORAL SOLID ORDINARY FILM-COATED TABLETS1.0X15.0X10.0 TABLET BLISTER01/07/2013
310NDA/MAL/HDP/0493MSN LABORATORIES LTDPLANET PHARMACEUTICALS UGANDA LTDPRASUSAFE 10PRASUGREL10MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2013
311NDA/MAL/HDP/0494BEXIMCO PHARMACEUTICALS LIMITEDKIMSY MEDS LTDINFORMET 500METFORMIN HYDROCHLORIDE500MGBEXIMCO PHARMACEUTICALS LTD-TONGI- 1711, GAZIPUR, BANGLADESH BANGLADESHORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2013
312NDA/MAL/HDP/0496ADCOCK INGRAM LIMITEDUGANDA HEALTH MARKETING GROUP LIMITEDMYPRODOLPARACETAMOL + IBUPROFEN + CODEINE PHOSPHATE250MG + 200MG + 10MGADCOCK INGRAM LIMITED -49C & D BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK, BANGALORE
560099, KARNATAKA STATE, INDIA
INDIAORAL SOLID ORDINARY CAPSULES1.0X20.0 CAPSULE BLISTER,1.0X3.0X10.0 CAPSULE BLISTER01/07/2014
313NDA/MAL/HDP/0497LABORATORY&ALLIED LTDHARLEYS UGANDA LIMITEDKEMOXYL DRY SUSPENSIONAMOXYCILLIN TRIHYDRATE125MG/5MLLABORATORY & ALLIED LTD-PLOT NO. 209/10349
OFF MOMBASA ROAD, NAIROBI
P.O. BOX 42875, NAIROBI, KENYA.
KENYAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE01/07/2014
314NDA/MAL/HDP/0498BEXIMCO PHARMACEUTICALS LTDKIMSY MEDS LTDEVO 500LEVOFLOXACIN500MGBEXIMCO PHARMACEUTICALS LTD-TONGI- 1711, GAZIPUR, BANGLADESH BANGLADESHORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X10.0 TABLET BLISTER01/07/2013
315NDA/MAL/HDP/0499NVS KENYA LTDSURGIPHARM (U) LIMITEDBANEOCIN OINTMENTBACITRACIN ZINC+NEOMYCIN SULPHATE250I.U + 5000I.UMERCK KGAA & CO.-HOSSLGASSE 20 9800 SPITTAL DRAU/ AUSTRIAAUSTRIATOPICAL EXTERNAL OINTMENTS1.0X20.0 G TUBE01/07/2014
316NDA/MAL/HDP/0502STEDMAN PHARMACEUTICALS LTDVEERAM HEALTHCARE (U) LIMITEDDREZ GARGLEIODINATED POVIDONE2%W/VSTEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA INDIAORAL LIQUID ORDINARY LIQUIDS1.0X50.0 ML BOTTLE,1.0X100.0 ML BOTTLE01/07/2013
317NDA/MAL/HDP/0505MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDOSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATE75MGMYLAN LABORATORIES LTD -- PLOT NO. H-12 & H-13 MIDCWALUJ INDUSTRIAL AREA AURANGABAD 431136 MAHARASTRAINDIAORAL SOLID ORDINARY CAPSULES1.0X30.0 CAPSULE CONTAINER,1.0X10.0 CAPSULE BLISTER01/07/2013
318NDA/MAL/HDP/0508ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDASTARGANPROMETHAZINE HYDROCHLORIDE25MGASTRA LIFE CARE (INDIA) PVT.LTD-PLOT 57/P, RAJODA-382220, BAVLA AHMEDABAD, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER01/07/1997
319NDA/MAL/HDP/0510GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDLIZOLID-600LINEZOLID600MGGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D INDIAORAL SOLID ORDINARY TABLETS1.0X5.0X4.0 TABLET STRIP01/07/2004
320NDA/MAL/HDP/0511STRIDES SHASUN LIMITEDDELMAW ENTERPRISES LIMITEDLAMIVUDINE, NEVIRAPINE AND ZIDOVUDINE LAMIVUDINE + NEVIRAPINE + ZIDOVUDINE150MG + 200MG + 300MGSTRIDES ARCOLAB LIMITED .-PLOT 9-12, DEWAN & SONS INDUSTRIAL AREA, VEOOR, PALGHAR, MAHARASHTRA 401404 INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X60.0 TABLET BOTTLE01/07/2013
321NDA/MAL/HDP/0514MANKIND PHARM LTDTATA UGANDA LIMITEDCEFAKIND-500CEFUROXIME AXETIL500MGBAROQUE PHARMACEUTICALS PVT LTD -192/2&3, SOKHADA-388 620 KHAMBHAT. DIST. ANAND GUJARAT INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER01/07/2013
322NDA/MAL/HDP/0517SANOFI AVENTIS KENYA LTDLABOREX UGANDA LIMITEDSHANVAC -BR- DNA HEPATITIS -B SURFACE ANTIGEN PURIFIED20MCG/MLSHANTHA BIOTECHNICS LTD -SURVEY NO. 274, ATHVELLI VILLAGE, MEDCHAL MANDAL – 501401, RANGA REDDY DISTRICT, ANDHRA PRADESH, INDIA INDIAPARENTERAL ORDINARY VIALS1.0X35.0X1.0 ML VIAL (1 ADULT DOSE),1.0X35.0X0.5 ML VIAL (1 PEDIATRIC DOSE)01/07/2015
323NDA/MAL/HDP/0518RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDCYCLORENACICLOVIR200MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA UGANDAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET STRIP01/07/2006
324NDA/MAL/HDP/0519MANKIND PHARM LTDTATA UGANDA LIMITEDCEFAKIND-250CEFUROXIME AXETIL250MGBAROQUE PHARMACEUTICALS PVT LTD -192/2&3, SOKHADA-388 620 KHAMBHAT. DIST. ANAND GUJARAT INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER01/07/2013
325NDA/MAL/HDP/0521ALKEM LABORATORIES LIMITEDABACUS PHARMA (AFRICA) LIMITEDPAN 40PANTOPRAZOLE SODIUM40MGALKEM LABORATORIES LTD .- VILLAGE THANA BADDI TEHSIL NALAGARH DIST SOLAN HIMACHAL PRADESHINDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER01/07/2014
326NDA/MAL/HDP/0522MEDLEY PHARMACEUTICALS LTDMEDVIN PHARMA LIMITEDVAZORTAN 50LOSARTAN POTASSIUM50MGMEDLEY PHARMACEUTICALS LTD -PLOT NO. 18 AND 19, SURVEY NO. 378/8 & 379/2, KEBRA INDUSTRIAL ESTATE, KACHIGAM
, DAMAN-396 210, INDIA
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2015
327NDA/MAL/HDP/0526LEBEN LABORATORIES LTDANDYCO PHARMACY (UGANDA) LTDAMILEB- 25AMITRIPTYLINE25MG LEBEN LABORATORIES PVT. LTD-PLOT NO. L-4, PHASE-III, MIDC,
AKOLA– 444 104 (MS).
INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X20.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER01/07/2014
328NDA/MAL/HDP/0528PHARMACIE BETHELABACUS PHARMA (AFRICA) LIMITEDCLARY 500CLARITHROMYCIN500MGLINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2013
329NDA/MAL/HDP/0529MANKIND PHARMA LIMITEDTATA UGANDA LIMITEDMOXIKIND-CVAMOXICILLIN + CLAVULANIC ACID200 MG + 28.5 MGMEDOPHARM PVT LTD -NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY-603203 TAMIL NADUINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML CONTAINER01/07/2013
330NDA/MAL/HDP/0531LEBEN LABORATORIES LTDANDYCO PHARMACY (UGANDA) LTDENDERM-GMCLOBETASOL PROPIONATE + GENTAMYCIN + MICONAZOLE NITRATE0.05%W/W + 0.10%W/W + 2.0%W/WLEBEN LABORATORIES PVT. LTD.-PLOT NO. L-4, PHASE –III, M.I.D.C, AKOLA, 444104, MAHARASHTRA, INDIA. INDIATOPICAL EXTERNAL CREAMS1.0X30.0 G TUBE,1.0X15.0 G TUBE01/07/2014
331NDA/MAL/HDP/0532PHARMACIE BETHELABACUS PARENTERAL DRUGS LIMITEDSARTAN-50LOSARTAN POTASSIUM50MGLINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2013
332NDA/MAL/HDP/0533MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIAKIMSY MEDS LTDTELKAST 5MONTELUKAST SODIUM5MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY CHEWABLE TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2013
333NDA/MAL/HDP/0534MANKIND PHARMA LIMITEDTATA UGANDA LIMITEDMOXIKIND-CV 375AMOXICILLIN + POTASSIUM CLAVULANATE250 MG + 125 MGMEDOPHARM PVT LTD.-NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADUINDIAORAL SOLID ORDINARY TABLETS1.0X2.0X6.0 TABLET BLISTER01/07/2014
334NDA/MAL/HDP/0536MANKIND PHARMA LIMITEDTATA UGANDA LIMITEDMOXIKIND-CV 625AMOXICILLIN + POTASSIUM CLAVULANATE500 MG + 125 MGMEDOPHARM PVT LTD.-NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADUINDIAORAL SOLID ORDINARY TABLETS1.0X2.0X6.0 TABLET BLISTER01/07/2014
335NDA/MAL/HDP/0538MICRO LABS LTDLABOREX UGANDA LIMITEDXONADINE 180FEXOFENADINE HYDROCHLORIDE180 MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2013
336NDA/MAL/HDP/0539MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIAKIMSY MEDS LTDTELKAST 4MONTELUKAST SODIUM4MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY CHEWABLE TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2013
337NDA/MAL/HDP/0540PHARMACIE BETHELABACUS PARENTERAL DRUGS LIMITEDHYDRICORTHYDROCORTISONE SODIUM SUCCINATE100MGLINCOLN PARENTERAL LTD-11, TRIMUL ESTATE, NEAR KHATRAJ CHOLADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT INDIAPARENTERAL ORDINARY DRY VIALS1.0X50.0X100.0 MG VIAL01/07/2014
338NDA/MAL/HDP/0541MICRO LABS LTDLABOREX UGANDA LIMITEDXONADINE 120FEXOFENADINE HYDROCHLORIDE120MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2013
339NDA/MAL/HDP/0542DAWA LIMITEDSUPER MEDIC LTDPHENBITALPHENOBARBITAL30MGDAWA LTD-BABA DOGO ROAD RUARAKAKENYAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2014
340NDA/MAL/HDP/0543UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTDWIDE SPECTRUM ENTERPRISES (U) LIMITEDGLIMERYL 2GLIMEPIRIDE2MGUNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD-P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSINGJORDANORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2013
341NDA/MAL/HDP/0544MICRO LABS LIMITEDLABOREX UGANDA LIMITEDDOLOWIN PLUSACECLOFENAC + PARACETAMOL100 MG + 500 MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2013
342NDA/MAL/HDP/0548UNITED PHARMACEUTICAL MANUFACTURING COMPANY LIMITEDWIDE SPECTRUM ENTERPRISES (U) LIMITEDUNICASTMONTELUKAST5MGUNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD .--P.O BOX 69 AMMAM 11591 JORDAN NUZHAT SAHID AL-RAQEEM NEAR PUBLIC HOUSING SECURITYJORDANORAL SOLID ORDINARY CHEWABLE TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2012
343NDA/MAL/HDP/0549ABOTT LABORATORIES S.A (PTY) LTDHARLEYS UGANDA LIMITEDHIDRASECRACECADOTRIL100 MGLABORATOIRES SOPHARTEX-21 RUE DU PRESSOIR, 28500 VERNOUILLET, FRANCE FRANCEORAL SOLID ORDINARY CAPSULES1.0X2.0X10.0 CAPSULE BLISTER01/07/2014
344NDA/MAL/HDP/0550DAWA LIMITEDSUPER MEDIC LTDDA-ZEPAMDIAZEPAM5MGDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER01/07/2014
345NDA/MAL/HDP/0551SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDREDAMOXAMOXICILLIN + CLAVULANIC ACID125 MG/ 5 ML + 31.25 MG/ 5 MLSAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIA INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE01/07/2014
346NDA/MAL/HDP/0552ABOTT LABORATORIES S.A (PTY) LIMITEDHARLEYS UGANDA LIMITEDHIDRASEC INFANTSRACECADOTRIL10 MGLABORATOIRES SOPHARTEX-21 RUE DU PRESSOIR, 28500 VERNOUILLET, FRANCE FRANCEORAL LIQUID ORDINARY OTHER POWDERS/GRANULES1.0X16.0 SACHET CARTON01/07/2014
347NDA/MAL/HDP/0553BHARAT SERUMS AND VACCINES LTDABACUS PHARMA (AFRICA) LIMITEDEQUIRABRABIES ANTISERUM1000IU/ 5MLBHARAT SERUMS AND VACCINES LIMITED,-PLOT NO. K-27, ADDITIONAL MIDC,
AMBERNATH (EAST), INDIA
INDIAPARENTERAL ORDINARY VIALS1.0X1.0X5.0 ML VIAL (5 DOSE VIAL)01/07/2013
348NDA/MAL/HDP/0555HOVID BHDUNITED HEALTHCARE DISTRIBUTORS LTDCARZEPINCARBAMAZEPINE200MGHOVID BHD-LOT 56442,71/2 MILES JALAN IPOH,PERAK,MALAYSIA MALAYSIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2013
349NDA/MAL/HDP/0556ABOTT LABORATORIES S.A (PTY) LTDHARLEYS UGANDA LIMITEDHIDRASEC CHILDRENRACECADOTRIL30 MGLABORATOIRES SOPHARTEX-21 RUE DU PRESSOIR, 28500 VERNOUILLET, FRANCE FRANCEORAL LIQUID ORDINARY OTHER POWDERS/GRANULES1.0X30.0 SACHET CARTON01/07/2014
350NDA/MAL/HDP/0557SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDREDAMOX 312.5AMOXICILLIN + POTASSIUM CLAVULANATE250 MG/5 ML + 62.5 MG/5 MLSAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIA INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE01/07/2013
351NDA/MAL/HDP/0558PHARMACIE BETHELABACUS PARENTERAL DRUGS LIMITEDABGENTA EYE DROPSGENTAMICIN SULPHATE0.3% W/VABACUS PARENTERAL DRUGS LIMITED-BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA. UGANDAOPHTHALMIC DROPS1.0X10.0 ML BOTTLE01/07/2014
352NDA/MAL/HDP/0559HOVID BHDMEDICAL ACCESS (UGANDA) LIMITEDDIABETMIN RETARDMETFORMIN HYDROCHLORIDE850MGHOVID BHD-LOT 56442,71/2 MILES JALAN IPOH,PERAK,MALAYSIA MALAYSIAORAL SOLID RETARD TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2014
353NDA/MAL/HDP/0560UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTDWIDE SPECTRUM ENTERPRISES (U) LIMITEDGLIMERYL 1GLIMEPIRIDE1MGUNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD .--P.O BOX 69 AMMAM 11591 JORDAN NUZHAT SAHID AL-RAQEEM NEAR PUBLIC HOUSING SECURITYJORDANORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2013
354NDA/MAL/HDP/0562KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAM COTRICO-TRIMOXAZOLE240MG/5MLKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALAUGANDAORAL LIQUID ORDINARY SUSPENSIONS100.0 ML BOTTLE,60.0 ML BOTTLE01/07/1997
355NDA/MAL/HDP/0563IND SWIFT LTDPLANET PHARMACEUTICALS UGANDA LTDEZO 40ESOMEPRAZOLE MAGNESIUM40MGIND-SWIFT-LTD,-GLOBAL BUSINESS UNIT, JAWAHARPUR, OFF NH-21 DERABASSI INDIAORAL SOLID RETARD TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2013
356NDA/MAL/HDP/0566SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDCEFROTIL SUSPENSIONCEFUROXIME AXETIL125MG/5MLSAKAR HEALTHCARE PVT. LTD-PLOT 10/13 SAKHEJ-BAVLA ROAD, AHMEDABAD,GUJURAT,INDIA INDIAORAL LIQUID ORDINARY SOLUBLE POWDERS1.0X1.0X50.0 ML BOTTLE01/07/2013
357NDA/MAL/HDP/0567KOTRA PHARMA SDN BDNABACUS PHARMA (AFRICA) LIMITEDVAXCEL CEFTRIAZONE 500MGCEFTRIAXONE500MGKOTRA PHARMA SDN BDN-1, 2, &3, JALANTTC12 CHENG INDUSTRIAL ESTATE, 75250, MELAKA, MALAYSIA MALAYSIAPARENTERAL ORDINARY DRY VIALS1.0X500.0 MG VIAL01/07/2013
358NDA/MAL/HDP/0568RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDFLUOXIRENFLUOXETINE20MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA UGANDAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER01/07/2013
359NDA/MAL/HDP/0569KOTRA PHARMA SDN BDNABACUS PHARMA (AFRICA) LIMITEDAXCELLRIDIN LINCTUSPHOLCODINE10MG/5MLKOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA MALAYSIAORAL LIQUID ORDINARY SYRUPS1.0X90.0 ML BOTTLE01/07/2014
360NDA/MAL/HDP/0570BHARAT SERUMS AND VACCINES LTDABACUS PHARMA (AFRICA) LIMITEDTETGLOB 250 I.UHUMAN TETANUS IMMUNOGLOBULIN250IUBHARAT SERUMS AND VACCINES LIMITED,-PLOT NO. K-27, ADDITIONAL MIDC,
AMBERNATH (EAST), INDIA
INDIAPARENTERAL ORDINARY I M VIALS1.0X1.0X2.0 ML VIAL (1 DOSE VIAL)01/07/2013
361NDA/MAL/HDP/0571KOTRA PHARMA (M) SDN BHDABACUS PHARMA (AFRICA) LIMITEDAXCEL KAOPECLIGHT KAOLIN + PECTIN (CITRUS)1G + 20MG/5MLKOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA MALAYSIAORAL LIQUID ORDINARY SUSPENSIONS1.0X120.0 ML BOTTLE01/07/2015
362NDA/MAL/HDP/0572NORVATIS PHARMA AG- SWITZERLANDLABOREX UGANDA LIMITEDAZARGABRINZOLAMIDE + TIMOLOL10MG/ML + 5MG/MLALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUM BELGIUMOPHTHALMIC DROPS1.0X5.0 ML VIAL01/07/2010
363NDA/MAL/HDP/0573KOTRA PHARMA (M) SDN,BHDABACUS PHARMA (AFRICA) LIMITEDAXCEL PARACETAMOL-250PARACETAMOL250MG/5MLKOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA MALAYSIAORAL LIQUID ORDINARY SUSPENSIONS1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE01/07/2014
364NDA/MAL/HDP/0574IPCA LABORATOIES LTDMEDVIN PHARMA LIMITEDARTESUNATE AND AMODIAQUINE TABLETS 100/270ARTESUNATE AND AMODIAQUINE100MG+270MGIPCA LABORATORIES LIMITED -SEJAVTA VILLAGE, DIST. RATLAM (M.P) 457002 INDIA. INDIAORAL SOLID ORDINARY TABLETS1.0X1.0X3.0 TABLET BLISTER, 1.0X1.0X6.0 TABLET BLISTER01/07/2013
365NDA/MAL/HDP/0575MICRO LABS LTDLABOREX UGANDA LIMITEDMICROMOXMOXIFLOXACIN400MG/100MLAHLCON PARENTERALS (INDIA) LTD-SP-917-918, PHASE-III BHIWADI-301019, ALWAR, RAJASTHAN INDIAPARENTERAL ORDINARY INFUSION BAGS1.0X100.0 ML BOTTLE01/07/2013
366NDA/MAL/HDP/0576GLAXO SMITH KLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDDUODARTDUTASTERIDE + TAMSULOSIN0.5MG + 0.4MGCATALENT GERMANY SCHONDORF GMBH -STEINBEISSTRASSE 1-2, 73614 SCHORNDORF, GERMANY GERMANYORAL SOLID ORDINARY CAPSULES1.0X30.0 CAPSULE CONTAINER01/07/2015
367NDA/MAL/HDP/0580KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDFLUCAPMULTINGREDIENTMULTINGREDIENTKAMPALA PHARMECEUTICALS INDUSTRIES LTD.-PLOT M444B STRETCHER RD, NTINDA KLA UGANDA UGANDAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER01/07/1997
368NDA/MAL/HDP/0582ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDACECLO SERAACECLOFENAC+PARACETAMOL+SERRATIOPEPTIDASE100MG + 500MG + 15MGARISTO PHARMACEUTICALS PVT LTD-VILLAGE: MAKHNUMAJRA P.O. BHUD BADDI DISTRIC: SOLAN (H.P) 173205INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER01/07/2015
369NDA/MAL/HDP/0584ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDTRIGLIMIPREX 1GLIMEPIRIDE+PIOGLITAZONE+METFORMIN HYDROCHLORIDE1MG+15MG+500MGARISTO PHARMACEUTICALS PVT LTD---VILLAGE MAKHNUMAJRA P.O BHUD BADDI DISTRICT SOLAN (H.P) 173205INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER01/07/2014
370NDA/MAL/HDP/0586CADILA PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.ONSETTONDANSETRON2MG/MLCADILA PHARMACEUTICALS LIMITED-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA INDIAPARENTERAL ORDINARY AMPOULES1.0X5.0X2.0 ML AMPOULE,1.0X5.0X4.0 ML AMPOULE01/07/2013
371NDA/MAL/HDP/0587CADILA PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.CADIGRELCLOPIDOGREL75MGCADILA PHARMACEUTICALS LIMITED-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2013
372NDA/MAL/HDP/0588AUROLABSWASTIK PHARMACEUTICAL LTDAUROFORTPREDNISOLONE ACETATE1%W/VAUROLAB-NO 1 SIVAGANGAI MAIN ROAD, VEERAPANJAN MADURAI – 625 020 TAMIL NADU, INDIA INDIAOPHTHALMIC SUSPENSIONS1.0X5.0 ML BOTTLE01/07/2013
373NDA/MAL/HDP/0589ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDTRIGLIMIPREX 2GLIMEPIRIDE+PIOGLITAZONE+METFORMIN HYDROCHLORIDE2MG+15MG+500MGARISTO PHARMACEUTICALS PVT LTD---VILLAGE MAKHNUMAJRA P.O BHUD BADDI DISTRICT SOLAN (H.P) 173205INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER01/07/2014
374NDA/MAL/HDP/0590BHARAT SERUMS AND VACCINES LTDABACUS PHARMA (AFRICA) LIMITEDASNA ANTIVENOM CB.GABONICA/B.ARIENTANS/ B.NASICORNIS/ DENDROASPIS/ POLYEPIS/D.ANGUSTICEPS/ N.NIVEA /N.NLGRCOLLIS/N.HAJE25/25/20/25/25/25/25/25/20/25/20/25 I.UBHARAT SERUMS AND VACCINES LIMITED,-PLOT NO. K-27, ADDITIONAL MIDC,
AMBERNATH (EAST), INDIA
INDIAPARENTERAL ORDINARY VIALS1.0X1.0X10.0 ML VIAL01/07/2012
375NDA/MAL/HDP/0592AUROLABSWASTIK PHARMACEUTICAL LTDAUROCHROMECROMOLYN SODIUM2%W/VAUROLAB-NO 1 SIVAGANGAI MAIN ROAD, VEERAPANJAN MADURAI – 625 020 TAMIL NADU, INDIA INDIAOPHTHALMIC LIQUIDS1.0X10.0 ML CONTAINER01/07/2013
376NDA/MAL/HDP/0593ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDPANTOP-DPANTOPRAZOLE SODIUM SESQUIHYDRATE + DOMPERIDONE CAPSULES20MG+10MGARISTO PHARMACEUTICALS PVT LTD .-MAKHNUMAJRA P.O BHUD BADDI DISTRICT SOLAN HIMACHAL PRADESHINDIAORAL SOLID ORDINARY ENTERIC-COATED CAPSULES1.0X10.0X10.0 CAPSULE STRIP,1.0X3.0X10.0 CAPSULE STRIP01/07/2014
377NDA/MAL/HDP/0594AUROLABSWASTIK PHARMACEUTICAL LTDAUROVISC-2ML PFSHYPROMELLOSE OPHTHALMIC SOLUTION USP2%W/VAUROLAB.-SIVAGANGAI MAIN ROAD, VEERAPANJAN, MADURAI 625 020 TAMIL INDIA INDIAOPHTHALMIC VIALS1.0X2.0 ML PRE- FILLED SYRINGE01/07/2013
378NDA/MAL/HDP/0595ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDORNOFORNIDAZOLE + OFLOXACIN500MG + 200MGARISTO PHARMACEUTICALS PVT LTD---VILLAGE MAKHNUMAJRA P.O BHUD BADDI DISTRICT SOLAN (H.P) 173205INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER01/07/2015
379NDA/MAL/HDP/0596MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDARBITEL-HTELMISARTAN/HYDROCHLOROTHIAZIDE40MG/12.5MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET STRIP01/07/2011
380NDA/MAL/HDP/0598INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDLIPICURE-20ATORVASTATIN20MGINTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER01/07/2003
381NDA/MAL/HDP/0599MICRO LABS LIMITEDLABOREX UGANDA LIMITEDGRAMOCEF-O-400CEFIXIME400MGMICROLABS LIMITED-PLOT NO. 121-124, KIADB, BOMMASANDRA , -JIGNI LINK ROAD, ANEKUL TALUK,BANGALORE, KARNATAKA, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X6.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER01/07/2013
382NDA/MAL/HDP/0600DENK PHARM GMBH&CO.KGBENLE CONSULT LIMITEDCARVEDI-DENK 6.25CARVEDILOL6.25MGARTESAN PHARMA GMBH & CO. KG -WENDLANDSTRABE 1,29439 LUCHOW,GERMANY GERMANYORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2015
383NDA/MAL/HDP/0603MEDLEY PHARMACEUTICALS LTDMEDVIN PHARMA LIMITEDGROMIN SYRUPMULTI-INGREDIENTMULTI-INGREDIENTMEDLEY PHARMACEUTICALS LTD-PLOT NO.18 AND 19, SURVEY NO.378/8 & 379/2, KEBRA INDUSTRIAL ESTATE, KACHIGAM, DAMAN-396210 INDIA INDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE01/07/1999
384NDA/MAL/HDP/0604DAWA PHARMACEUTICALS LIMITEDSUPER MEDIC LTD-MBARARATRIMOXOLCO-TRIMOXAZOLE480MGDAWA LIMITED -16633-00620, RUARAKA, BABA DOGO ROAD, NAIROBI KENYAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER01/07/1997
385NDA/MAL/HDP/0605DENK PHARM GMBH&CO.KGBENLE CONSULT LIMITEDCARVEDI-DENK 25CARVEDILOL25MGARTESAN PHARMA GMBH & CO. KG -WENDLANDSTRABE 1,29439 LUCHOW,GERMANY GERMANYORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2015
386NDA/MAL/HDP/0608CIPLA LTDQUALITY CHEMICALS LTD - HUMANLOPINAVIR AND RITONAVIR TABLETS 200MG/50MGLOPINAVIR + RITONAVIR200MG + 50MGCIPLA LTD -MIDC PATALGANGA MS 410 220 INDIA MFG LIC: 845
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X120.0 TABLET BOTTLE01/07/2012
387NDA/MAL/HDP/0609DENK PHARMA GMBH & CO KGBENLE CONSULT LIMITEDCLOPI-DENK 75CLOPIDOGREL BESYLATE75MGARTESAN PHARMA GMBH & CO. KG -WENDLANDSTRABE 1,29439 LUCHOW,GERMANY GERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2015
388NDA/MAL/HDP/0610PHARMACIE BETHELABACUS PARENTERAL DRUGS LIMITEDPYLOR KITLANSOPRAZOLE DELAYED RELEASE + CLARITHROMYCIN+ TINIDAZOLE30MG + 250MG + 500MGLINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X7.0X1.0X6.0 TABLET BLISTER (BLISTER CONTAINS 2 CAPSULES AND 4 TABLETS)01/07/2014
389NDA/MAL/HDP/0611GALPHAR LABORATORIES LTDAIVEEN (U) LIMITEDGALCIPRO 500CIPROFLOXACIN HYDROCHLORIDE500MGGALPHA LABORATORIES LIMITED-VILLAGE – THANA BADDI, TEHSIL BADDI
SOLAN HIMACHAL PRADESH-173 205 INDIA
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390NDA/MAL/HDP/0614GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDCLAVULINAMOXICILLIN + CLAVULANIC ACID126 MG/ 5 ML + 31.25 MG/ 5 MLSMITHKLINE BEECHAM PHARMACEUTICALS,-CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QH UNITED KINGDOMORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X70.0 ML BOTTLE,1.0X100.0 ML BOTTLE01/07/1998
391NDA/MAL/HDP/0615HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDVALSAR 80VALSARTAN80MGHETERO LABS LTD. UNIT (V)-S.N0.439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE),
JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA
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392NDA/MAL/HDP/0617PHARMACIE BETHELABACUS PARENTERAL DRUGS LIMITEDSILVEXSILVER SULFADIAZINE + CHLORHEXIDINE1%W/W + 0.2%W/WLINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT INDIATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE01/07/2014
393NDA/MAL/HDP/0618HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDVALSAR 160VALSARTAN160MGHETERO LABS LTD. UNIT (V)-439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE),
JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA.
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394NDA/MAL/HDP/0619PHARMACIE BETHELABACUS PARENTERAL DRUGS LIMITEDD10GLUCOSE10%W/VABACUS PARENTERAL DRUGS LTD-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE,
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UGANDAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X500.0 ML BOTTLE,1.0X250.0 ML BOTTLE01/07/2013
395NDA/MAL/HDP/0621HETERO LABS LTDAIVEEN (U) LIMITEDALZERDONEPEZIL HYDROCHLORIDE10MGHETERO LABS LTD. UNIT (V)-439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE),
JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA.
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396NDA/MAL/HDP/0623PHARMACIE BETHELABACUS PARENTERAL DRUGS LIMITEDGELCIDMAGNESIUM SULPHATE50%W/VLINCOLN PHARMACEUTICALS LTD--11 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT INDIAPARENTERAL ORDINARY AMPOULES1.0X10.0X5.0X10.0 ML AMPOULE,1.0X10.0X5.0X5.0 ML AMPOULE IN BLISTER PACK,1.0X5.0 ML AMPOULE IN BLISTER PACK01/07/2015
397NDA/MAL/HDP/0625SANOFI PASTEURLABOREX UGANDA LIMITEDVERORABRABIES VACCINE1 DOSESANOFI PASTEUR-1541 AVENUE MARCEL MERIEUX, 69280 MARCY, LETOILE FRANCEPARENTERAL ORDINARY VIALS1.0X1.0 DOSE VIAL,1.0X5.0X1.0 DOSE VIAL + 1.0X5.0X0.5ML GLASS AMPOULES OF 0.9% SODIUM CHLORIDE01/07/1997
398NDA/MAL/HDP/0626KPI INDUSTRIES(1996) LTEDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDCARDIPAC-10AMLODIPINE BESILATE10MGKPI INDUSTRIES (1996) LTD-PLOT NO.M444B STRETCHER RD, NTINDA, KAMPALA UGANDAORAL SOLID ORDINARY TABLETS1.0X1.0X10.0X10.0 TABLET BLISTER01/07/2015
399NDA/MAL/HDP/0627KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDAMOXIKIDAMOXICILLIN TRIHYDRATE125MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD-PLOT M 444B STRETCHER ROAD NTINDAUGANDAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET STRIP,1.0X2.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER01/07/2015
400NDA/MAL/HDP/0630CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDNEO LORIDINDESLORATADINE5MGCADILA HEALTHCARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO.203-213, KUNDAIM GOA, 403115, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER01/07/2011
401NDA/MAL/HDP/0633PHARMACIE BETHELABACUS PARENTERAL DRUGS LIMITEDCIPROCINCIPROFLOXACIN0.3%W/VABACUS PARENTERAL DRUGS LTD-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE,
MUKONO
UGANDAOPHTHALMIC DROPS1.0X10.0 ML VIAL01/07/2013
402NDA/MAL/HDP/0634MEDLEY PHARMACEUTICALSMEDVIN PHARMA LIMITEDTRISOLIVANDROGRAPHOLIDES/TRICHOLINE CITRATE50MCG+50MG/MLMEDLEY PHARMACEUTICALS LTD-PLOT NO.18 AND 19, SURVEY NO.378/8 & 379/2, KEBRA INDUSTRIAL ESTATE, KACHIGAM, DAMAN-396210 INDIA INDIAORAL LIQUID ORDINARY SYRUPS1.0X200.0 ML BOTTLE01/07/2014
403NDA/MAL/HDP/0635AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGO-AMINAMINOPHYLLINE100MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER01/07/2009
404NDA/MAL/HDP/0636MYLAN LABS LTDNORVIK ENTERPRISES LIMITEDREVOKE-1.5LEVONORGESTREL1.5MGMYLAN LABORATORIES LIMITED.--PLOT NO. 1606-1609, SARIGAM INDUSTRIAL AREA, GIDC, SARIGAM, TAL-UMERGAM, DIST VALSAD, 396155, GUJARAT, INDIA. MYLAN LABORATORIES LIMITED..-PLOT NO.20 & 21, PHARMEZ, SARKHEJ-BAVLA NATIONAL HIGHWAY NO. 08A, NEAR VILLAGE MATODA, TAL-SANAND, AHMEDABAD, GUJARAT, INDIA 382213 INDIAORAL SOLID ORDINARY TABLETS1.0X1.0 TABLET BLISTER01/07/2014
405NDA/MAL/HDP/0637NABIQASIM INDUSTRIES (PVT) LIMITEDJEET PHARMACEUTICALS LIMITEDZUDICORTFUSIDIC ACID + BETAMETHASONE VALERATE20MG + 1MG/GNABIQASIM INDUSTRIES (PVT) LIMITED-17/24, KORANGI INDUSTRIAL AREA, KARACHI, PAKISTAN PAKISTANTOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE01/07/2014
406NDA/MAL/HDP/0638PHARMACIE BETHELABACUS PARENTERAL DRUGS LIMITEDABLOL-5 EYE DROPSTIMOLOL MALEATE0.5% W/VABACUS PARENTERAL DRUGS LTD-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE,
MUKONO
UGANDAOPHTHALMIC DROPS1.0X10.0 ML VIAL01/07/2013
407NDA/MAL/HDP/0639NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDRHEUMATIC CREAMMULTI-INGREDIENTMULTI-INGREDIENTNEM LABORATORIES PVT LTD-133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAIINDIATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE01/07/1997
408NDA/MAL/HDP/0640SANDOZ KENYA C/O NOVARTIS PHARMA SERVICES INCSURGIPHARM (U) LIMITEDBIODROXIL 250MG/5MLCEFADROXIL (ANHYDROUS)250MG/5MLSANDOZ GMBH-BIOCHEMIESTRASSE 10, A6250 KUNDL, TYROL, AUSTRIA AUSTRIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X60.0 ML BOTTLE01/07/2013
409NDA/MAL/HDP/0641PHARMACIE BETHELABACUS PARENTERAL DRUGS LIMITEDGYNAZOLECLOTRIMAZOLE2%W/WLINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT INDIATOPICAL EXTERNAL CREAMS1.0X30.0 G TUBE01/07/2014
410NDA/MAL/HDP/0643NAARI AGECHO PHARMACY (U) LIMITEDMISOPROMISOPROSTOL200MCGNAARI PHARMA PRIVATE LIMITED-PLOT NO. 14-16, 55-57, SECTOR-5, IIE, PANT NAGAR RUDRAPUR-263153 DIST-U.S. NAGAR UTTARAKHAND ARGENTINAORAL SOLID ORDINARY TABLETS1.0X4.0 TABLET BLISTER01/07/2013
411NDA/MAL/HDP/0651SANDOZ KENYA C/O NOVARTIS PHARMA SERVICES INCSURGIPHARM (U) LIMITEDBIODROXIL 500MGCEFADROXIL (ANHYDROUS)500MGSANDOZ GMBH-BIOCHEMIESTRASSE 10, A6250 KUNDL, TYROL, AUSTRIA AUSTRIAORAL SOLID ORDINARY CAPSULES1.0X2.0X6.0 CAPSULE BLISTER01/07/2013
412NDA/MAL/HDP/0652NVS KENYA LTDSURGIPHARM (U) LIMITEDGALVUSVILDAGLIPTIN50MGNOVARTIS PHARMA STEIN AG-SCHAFFHARVSERTRASSE CH-4332 STEIN SWITZERLAND. NOVARTIS BARBERA -SPAINSWITZERLANDORAL SOLID ORDINARY TABLETS1.0X4.0X14.0 TABLET BLISTER01/07/2014
413NDA/MAL/HDP/0654NVS KENYA LTDSURGIPHARM (U) LIMITEDGALVUS METVILDAGLIPTIN / METFORMIN50MG/500MGNORVATIS PHARMA PRODUCTIONS GMBH, WEHR-GERMANY GERMANYORAL SOLID ORDINARY TABLETS1.0X60.0 TABLET CONTAINER01/07/2013
414NDA/MAL/HDP/0657NVS KENYA LTDSURGIPHARM (U) LIMITEDGALVUS METVILDAGLIPTIN / METFORMIN50MG / 850MGNORVATIS PHARMA PRODUCTIONS GMBH, WEHR-GERMANY GERMANYORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X6.0X10.0 TABLET BLISTER01/07/2013
415NDA/MAL/HDP/0658NVS KENYA LTDSURGIPHARM (U) LIMITEDGALVUS METVILDAGLIPTIN/ METFORMIN50MG/1000MGNORVATIS PHARMA PRODUCTIONS GMBH, WEHR-GERMANY GERMANYORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X6.0X10.0 TABLET BLISTER01/07/2013
416NDA/MAL/HDP/0662PHARMAVET LTDDELMAW ENTERPRISES LIMITEDRECTIN 100INDOMETHACIN100MGBLISS GVS PHARMA LTD-PLOT.NO 10,SURVEY NO 38/1,DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR, TAL: PALGHAR DIST.THANE, MAHARASHTRA-INDIA INDIARECTAL SYSTEMIC ADULT SUPPOSITORIES1.0X2.0X5.0 SUPPOSITORY STRIP01/07/2014
417NDA/MAL/HDP/0663BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDGLYCERINGLYCERIN1GBLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIAINDIARECTAL SYSTEMIC ADULT SUPPOSITORIES1.0X5.0 SUPPOSITORY STRIP01/07/2014
418NDA/MAL/HDP/0665HETERO LABS LTDAIVEEN (U) LIMITEDIRBIS 150IRBESARTAN150MGHETERO LABS LTD (UNIT-V)-SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X1.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER01/07/2013
419NDA/MAL/HDP/0666HETERO LABS LTDAIVEEN (U) LIMITEDIRBIS-H 300IRBESARTAN300MGHETERO LABS LTD (UNIT-V)-SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X1.0X10.0 TABLET BLISTER01/07/2013
420NDA/MAL/HDP/0667KOTRA PHARMA (M) SDN,BHDABACUS PHARMA (AFRICA) LIMITEDAXEL MICONAZOLEMICONAZOLE NITRATE2%W/WKOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA MALAYSIATOPICAL EXTERNAL CREAMS1.0X5.0 G TUBE,1.0X15.0 G TUBE01/07/2013
421NDA/MAL/HDP/0668CADILA PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.TELI 40TELMISARTAN40MGCADILA PHARMACEUTICALS LIMITED-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2013
422NDA/MAL/HDP/0669KOTRA PHARMA (M) SDN,BHDABACUS PHARMA (AFRICA) LIMITEDAXEL FUNGICORT CREAMMICONAZOLE NITRATE + HYDROCORTISONE2% W/W + 1% W/WKOTRA PHARMA SDN BDN-1, 2, &3, JALANTTC12 CHENG INDUSTRIAL ESTATE, 75250, MELAKA, MALAYSIA MALAYSIATOPICAL EXTERNAL CREAMS1.0X5.0 G TUBE,1.0X15.0 G TUBE01/07/2013
423NDA/MAL/HDP/0670AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDFLUNAZ-200FLUCONAZOLE200MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIAORAL SOLID ORDINARY CAPSULES1.0X4.0 CAPSULE BLISTER,1.0X5.0X4.0 CAPSULE BLISTER01/07/2014
424NDA/MAL/HDP/0671KOTRA PHARMA (M) SDN BHDABACUS PHARMA (AFRICA) LIMITEDAXCEL LIGNOCAINELIDOCAINE2%W/WKOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA MALAYSIATOPICAL EXTERNAL GELS AND SOLS1.0X20.0 G TUBE01/07/2014
425NDA/MAL/HDP/0672AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGONOR TABLETSNORFLOXACIN400MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER01/07/2013
426NDA/MAL/HDP/0673MIRACLE CENTRE KAWEMPEKARURI PHARMACEUTICALS LTD.ONSETT 8ONDANSETRON8MGB. BRAUN MELSUNGEN - MISTELWEG-1389, TRABAD ROAD, DHOLKA 387 810, DISTRICT AHMEDABAD, GUJARAT, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2013
427NDA/MAL/HDP/0674AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGODAPS-100DAPSONE100MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER01/07/2013
428NDA/MAL/HDP/0675KOTRA PHARMA (M) SDN,BHDABACUS PHARMA (AFRICA) LIMITEDAXCEL METRONIDAZOLE 400METRONIDAZOLE400MGKOTRA PHARMA-BHD
1, JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA, MALAYSIA
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429NDA/MAL/HDP/0676CADILA PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.ONSETT 4ONDANSETRON4MGCADILA PHARMACEUTICALS LIMITED-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2013
430NDA/MAL/HDP/0677AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDDOPAMETMETHYLDOPA250MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2014
431NDA/MAL/HDP/0678KOTRA PHARMA (M) SDN BHDABACUS PHARMA (AFRICA) LIMITEDAXCEL HYDROCORTISONE CREAMHYDROCORTISONE1%W/WKOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA MALAYSIATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE,1.0X5.0 G TUBE01/07/2014
432NDA/MAL/HDP/0679AGOG PHARMAGITTOES PHARMACEUTICALS LIMITEDMEFENA-250 CAPSULESMEFENAMIC ACID250MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY OTHER CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0X10.0 CAPSULE BLISTER01/07/2013
433NDA/MAL/HDP/0681GENNOVA BIOPHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDELAXIM 40TENECTEPLASE (RECOMBINANT TISSUE PLASMINOGEN ACTIVATOR)40MG/VIALEMCURE PHARMACEUTICALS LTD .-PLOT NO. P-2 IT-BT PARK PHASE II MIDC HINJWADI PUNE 411057INDIAPARENTERAL ORDINARY DRY VIALS1.0X40.0 MG VIAL , 1*8 ML VIAL OF WFI01/07/2013
434NDA/MAL/HDP/0684TROGE MEDICAL GMBHECHO PHARMACY (U) LIMITEDTRO-CEFTRIAX 1GCEFTRIAXONE1GREYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100 CHINAPARENTERAL ORDINARY DRY VIALS1.0X1.0 G VIAL + 1X5ML WFI AMPOULE01/07/2014
435NDA/MAL/HDP/0685FERRER INTERNACIONAL S.ALABOREX UGANDA LIMITEDSOMAZINACITICOLINE1000MGFERRER INTERNACIONAL S.A --GRAN VIA CARLOS III 94 08028 BARCELONASPAINPARENTERAL RETARD I M AMPOULES1.0X5.0X4.0 ML AMPOULE01/07/2015
436NDA/MAL/HDP/0687FERRER INTERNACIONAL S.ALABOREX UGANDA LIMITEDSOMAZINACITICOLINE1000MGFERRER INTERNACIONAL S.A --GRAN VIA CARLOS III 94 08028 BARCELONASPAINORAL LIQUID ORDINARY LIQUIDS1.0X6.0X10.0 ML SACHET01/07/2015
437NDA/MAL/HDP/0688AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDHBBHYOSCINE BUTYLBROMIDE10MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY COATED TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2014
438NDA/MAL/HDP/0689AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGONALNALIDIXIC ACID500MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2013
439NDA/MAL/HDP/0690MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDHEALTHEASE CREAMBECLOMETHASONE DIPROPRIONATE + PHENYLEPHRINE HCL + LIGNOCAINE HCL + CHLOROCRESOL0.025%W/W + 0.1%W/W + 2.5%W/W + 0.1%W/WTORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506INDIATOPICAL EXTERNAL CREAMS1.0X30.0 G TUBE01/07/2014
440NDA/MAL/HDP/0691MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDOLMAT-20OLMESARTAN MEDOXOMIL20 MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2013
441NDA/MAL/HDP/0692DAWA LIMITEDSUPER MEDIC LTDDAWACLOX -250CLOXACILLIN SODIUM250MGDAWA LIMITED -BABA DOGO RWARAKAKENYAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER01/07/2015
442NDA/MAL/HDP/0693DAWA LIMITEDSUPER MEDIC LTDMOXACIL -250AMOXYCILLIN TRIHYDRATE250MGDAWA PHARMACEUTICALS LIMITED-PLOT 7879, BABA DOGO ROAD RUARAKA KENYAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER01/07/2014
443NDA/MAL/HDP/0694AGOG PHARMA LTD.GITTOES PHARMACEUTICALS LIMITEDDT ZINC-20 TABLETSZINC SULPHATE20MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIAORAL SOLID ORDINARY SOLUBLE TABLETS1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET CARTON01/07/2013
444NDA/MAL/HDP/0696HETERO LABS LTDAIVEEN (U) LIMITEDRITONAVIRRITONAVIR100MGHETERO LABS LTD-22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESHINDIAORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET CONTAINER01/07/2014
445NDA/MAL/HDP/0698ELYS CHEMICAL INDUSTRIES LTDVELVET PHARMA LIMITEDWHITFIELD'S OINTMENTBENZOIC ACID+SALICYLIC CID6%W/W + 3%W/WELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBI KENYATOPICAL EXTERNAL OINTMENTS1.0X20.0 G TUBE01/07/2003
446NDA/MAL/HDP/0700CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDVAXIRAB NINACTIVATED RABIES VIRUS(PITMAN MOORE STRAIN)>2.5 I.UCADILA HEALTHCARE LTD---SARKHEJ-PLOT 417,419,420, SARKHEJ-BAVLA NH NO.8A,VILLAGE: MORAIYA TAL: SANAND DISTRICT AHMEDABAD 382210 INDIAPARENTERAL ORDINARY VIALS1.0X1.0 ML VIAL + 1ML AMPOULE OF WFI(1 DOSE VIAL)01/07/2015
447NDA/MAL/HDP/0702ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDSEPTOCINSTREPTOMYCIN SULPHATE1GMREYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100 CHINAPARENTERAL ORDINARY DRY VIALS1.0X50.0X1.0 G VIAL01/07/2014
448NDA/MAL/HDP/0703GOOD DAY PHARMACY LIMITEDPLANET PHARMACEUTICALS UGANDA LTDDICLODAY GELDICLOFENAC DIETHYLAMINE+ LINSEED OIL+ METHYL SALICYLATE +MENTHOL11.6MG + 30MG + 100MG + 50MGKREMOINT PHARMA PVT LTD---B-8 ADDITIONAL AMBERNATH MIDC OPP. ANAND NAGAR POLICE CHECK POST AMBERNATH (E) DIST THANE 421 506INDIATOPICAL EXTERNAL GELS AND SOLS1.0X30.0 G TUBE01/07/2013
449NDA/MAL/HDP/0704HETERO LABS LTD UNIT IXAIVEEN (U) LIMITEDM-FLOXMOXIFLOXACIN HYDROCHLORIDE400MGHETERO LABS LTD (UNIT-V)-SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIA HETERO LABS LTD-UNIT II & III BADDI THE NALAGARH DIST SOLAN H.P INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER,10.0X1.0X5.0 TABLET BLISTER01/07/2013
450NDA/MAL/HDP/0705LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDACICLOVIRACICLOVIR5%W/WLINCOLN PHARMACEUTICAL LIMITED-TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIA INDIATOPICAL EXTERNAL CREAMS1.0X10.0 G TUBE01/07/2011
451NDA/MAL/HDP/0706INTAS PHARMACEUTICALS LIMITEDNORVIK ENTERPRISES LIMITEDROVAS 5ROSUVASTATIN5MGINTAS PHARMACEUTICALS LIMITED -CAMP ROAD, SELAQUI-248197,DEHRADUN UTTARAKHAND, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2013
452NDA/MAL/HDP/0707HETERO LABS LTDAIVEEN (U) LIMITEDPENVIR 500FAMCICLOVIR500MGHETERO LABS LTD(UNIT V).-JADCHERLA (M),MAHABOOBNAGAR DIST, ANDHRA PRADESH,INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2013
453NDA/MAL/HDP/0710INTAS PHARMACEUTICALS LIMITEDNORVIK ENTERPRISES LIMITEDROVAS 20ROSUVASTATIN20MGINTAS PHARMACEUTICALS LIMITED -CAMP ROAD, SELAQUI-248197,DEHRADUN UTTARAKHAND, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2013
454NDA/MAL/HDP/0712GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDZENTELALBENDAZOLE100MG/5MLFARMACLAIR -440 AVENUE DU GENERAL DE GAULLE 14200 HEROUVILLE SAINT CLAIR FRANCEFRANCEORAL LIQUID ORDINARY SUSPENSIONS1.0X20.0 ML BOTTLE01/07/1997
455NDA/MAL/HDP/0713DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDPANTO-DENK 20PANTOPRAZOLE SODIUM SESQUIHYDRATE20MGADVANCE PHARMA GMBH..-WALLENRODER STR.12-14, 13435 BERLIN GERMANYORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X2.0X14.0 TABLET BLISTER01/07/2015
456NDA/MAL/HDP/0715DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDPANTO-DENK 40PANTOPRAZOLE SODIUM SESQUIHYDRATE40MGADVANCE PHARMA GMBH..-WALLENRODER STR.12-14, 13435 BERLIN GERMANYORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X2.0X14.0 TABLET BLISTER01/07/2015
457NDA/MAL/HDP/0716LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDGLYMET-1GLIMEPIRIDE+METFORMIN HYDROCHLORIDE1MG + 500MGLINCOLN PHARMACEUTICALS L.T.D-TRIMUL ESTATE KHATRAJ 382721 GHANDINAGAR GUJARATINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER01/07/2014
458NDA/MAL/HDP/0718LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDGLYMET-2GLIMEPIRIDE+METFORMIN HYDROCHLORIDE2MG + 500MGLINCOLN PHARMACEUTICALS L.T.D-TRIMUL ESTATE KHATRAJ 382721 GHANDINAGAR GUJARATINDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X5.0X10.0 TABLET BLISTER01/07/2014
459NDA/MAL/HDP/0719WOCKHARDT LTDSTAR PHARMACEUTICALS LTDWEPOX 4000RECOMBINANT HUMAN ERYTHROPOIETIN4000 I.UWOCKHARDT LIMITED --WOCKHARDT BIOTECH PARK, H14/2, M.I.D.C, WALUJ, AURANGABAD 431136 MAHARASHTRA INDIA INDIAPARENTERAL ORDINARY PRE-FILLED SYRINGES1.0X0.4 ML PRE- FILLED SYRINGE01/07/2011
460NDA/MAL/HDP/0720STEDMAN PHARMACEUTICALS PVT. LTDVEERAM HEALTHCARE (U) LIMITEDJUSDEE 400 DROPSCOLECALCIFEROL400 I.U/MLSTEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA INDIAORAL LIQUID ORDINARY DROPS1.0X15.0 ML BOTTLE01/07/2013
461NDA/MAL/HDP/0721MISSION PHARMAMETRO PHARMACEUTICALS LIMITEDARH-AARTEMETHER80MG/MLLINCOLN PARENTERAL LTD-11, TRIMUL ESTATE, NEAR KHATRAJ CHOLADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT INDIAPARENTERAL ORDINARY I M AMPOULES1.0X2.0X3.0X1.0 ML AMPOULE,1.0X1.0X6.0 ML AMPOULE01/07/2014
462NDA/MAL/HDP/0722FDC LTDAIVEEN (U) LIMITEDIOTIM 0.5%TIMOLOL MALEATE0.5% W/VFDC LIMITED -B-8, M.I.D.C., INDUSTRIAL AREA, WALUJ – AURANGABAD- 431 136 MAHARASHTRA, INDIA. INDIAOPHTHALMIC DROPS1.0X5.0 ML BOTTLE07/01/14
463NDA/MAL/HDP/0725TROIKAA PHARMACEUTICALS LIMITEDABACUS PHARMA (AFRICA) LIMITEDSPASMOTROY 40DROTAVERINE HYDROCHLORIDE40MG TROIKAA PHARMACEUTICALS LTD .-SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHAND, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER01/07/2013
464NDA/MAL/HDP/0726TROIKAA PHARMACEUTICALS LIMITEDABACUS PHARMA (AFRICA) LIMITEDT DOL RAPIDTRAMADOL HYDROCHLORIDE50MGTROIKAA PHARMACEUTICALS LTD- SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHANDINDIAORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS1.0X10.0X10.0 TABLET STRIP01/07/2014
465NDA/MAL/HDP/0727MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDSTOMACH FIT SYRUPBISMUTH AMMONIUM CITRATE+BELLADONA DRY EXTRACT+THYMOL+MENTHOL140MG+9MG+0.15MG+0.2/5MLTORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506INDIAORAL LIQUID ORDINARY LIQUIDS1.0X225.0 ML BOTTLE01/07/2013
466NDA/MAL/HDP/0728IPCA LABORATOIES LTDMEDVIN PHARMA LIMITEDARTESUNATE AND AMODIAQUINE 25/67.5ARTESUNATE+AMODIAQUINE25MG+67.5MGIPCA LABORATORIES LIMITED -SEJAVTA VILLAGE, DIST. RATLAM (M.P) 457002 INDIA. INDIAORAL SOLID ORDINARY TABLETS1.0X1.0X3.0 TABLET BLISTER01/07/2013
467NDA/MAL/HDP/0731IPCA LABORATORIES LTDMEDVIN PHARMA LIMITEDARTESUNATE AND AMODIAQUINE 50/135ARTESUNATE + AMODIAQUINE50/135MGIPCA LABORATORIES LIMITED -SEJAVTA VILLAGE, DIST. RATLAM (M.P) 457002 INDIA. INDIAORAL SOLID ORDINARY TABLETS1.0X1.0X3.0 TABLET BLISTER01/07/2013
468NDA/MAL/HDP/0732ANHIUMAISHA MEDICAL SUPPLIES LIMITEDVOLTAMED-100DICLOFENAC100 MGMEDICO REMEDIES PVT LIMITED-8 & 9 DEWAN & SONS, UDYOG NAGAR PALGAR, DISTRICT THANE MAHARASHTRA, INDIA INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2015
469NDA/MAL/HDP/0733CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDZYNACACECLOFENAC100MGCADILA HEALTH CARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2013
470NDA/MAL/HDP/0734ANHIUMAISHA MEDICAL SUPPLIES LIMITEDOMMED -20OMEPRAZOLE20MGMEDICO REMEDIES PVT LIMITED-8 & 9 DEWAN & SONS, UDYOG NAGAR PALGAR, DISTRICT THANE MAHARASHTRA, INDIA INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE STRIP01/07/2015
471NDA/MAL/HDP/0736MEDOCHEMIE LTDBOOTS PHARMACEUTICALS LIMITEDMABRON 50TRAMADOL HYDROCHLORIDE50MGMEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY.-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA CYPRUSORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER01/07/2013
472NDA/MAL/HDP/0737SANOFI AVENTISLABOREX UGANDA LIMITEDTAXOTERE 80MGDOCETAXEL TRIHYDRATE80MG/4MLSANOFI-AVENTIS DEUTSCHLAND GMBH -INDUSTRIEPARK HOECHST, BRUNINGSTRASSEN, BUILDING
H650 65926 FRANKFURT AM MAIN, GERMANY
GERMANYPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X4.0 ML VIAL01/07/2014
473NDA/MAL/HDP/0739SANOFI AVENTISLABOREX UGANDA LIMITEDTAXOTERE 20MGDOCETAXEL TRIHYDRATE20MG/MLSANOFI-AVENTIS DEUTSCHLAND GMBH-INDUSTRIEPARK HOESCHST,BRUNINGSTRASSEN BUIDING,H65065926, FRANKFURT AM MAIN GERMANYPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X1.0 ML VIAL01/07/2014
474NDA/MAL/HDP/0740MEDOCHEMIE LTDBOOTS PHARMACEUTICALS LIMITEDCOTRIMCO-TRIMOXAZOLE960MGMEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY.-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA CYPRUSORAL SOLID ORDINARY TABLETS1.0X17.0X6.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER01/07/2013
475NDA/MAL/HDP/0741MEDOCHEMIE LTDBOOTS PHARMACEUTICALS LIMITEDMEDOCIPRINCIPROFLOXACIN500MG MEDOCHEMIE LTD (FACTORY AZ)-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS, INDUSTRIAL AREA, 4101 AGIOS ATHANASSIOS, LIMASSOL, CYPRUS CYPRUSORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER01/07/2013
476NDA/MAL/HDP/0742MEDOCHEMIE LTDBOOTS PHARMACEUTICALS LIMITEDBROTMETFORMIN HYDROCHLORIDE500MGMEDOCHEMIE LTD-CENTRAL FACTORY A-1-10 CONSTANTINOUPOLEUS STREET 3011 LIMASSOLCYPRUSORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2013
477NDA/MAL/HDP/0745CADILA PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.TELI 80TELMISARTAN80MGB. BRAUN MELSUNGEN - MISTELWEG-1389, TRABAD ROAD, DHOLKA 387 810, DISTRICT AHMEDABAD, GUJARAT, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2013
478NDA/MAL/HDP/0746COSMOS LTDASTRA PHARMA (U) LIMITEDDTS-Z KITTABLET-ZINC, SACHET-NACL + KCL + TRISODIUM CITRATE + ANHYDROUS GLUCOSETABLET-54.89MG , SACHET 1.3G + 0.75G + 1.45G + 6.75GCOSMOS LIMITED, KENYA-RANGWE ROAD, OFF LUNGA ROAD, INDUSTRIAL AREA
NAIROBI - KENYA
KENYAORAL LIQUID ORDINARY UNIT DOSE POWDERS1.0X4.0X10.3 G SACHET + 1.0X10.0 TABLET BLISTER01/07/2013
479NDA/MAL/HDP/0747MEDIPHARM INDUSTRIES LTDMEDIPHARM INDUSTRIES (E.A) LTDORALYTE ORANGE CO-PACKGLUCOSE ANHYDROUS + SODIUM CHLORIDE + TRISSODIUM CITRATE DEHYDRATE + POTASSIUM CHLORIDE / ZINC SULPHATE13.5G + 2.6G + 2.9G + 1.5G/ SACHET + 27.43MG/5ML: MEDIPHARM INDUSTRIES LTD-PLOT 65, KAKAJJO ROAD, BWEYOGERERE
POSTAL ADDRESS : P.O.BOX 5917, KAMPALA.
UGANDAORAL LIQUID ORDINARY OTHER SOLID SPECIAL FORMS1.0X20.8 G SACHET + 60 ML BOTTLE01/07/2013
480NDA/MAL/HDP/0748BAYER PHARMASURGIPHARM (U) LIMITEDXARELTO 15MGRIVAROXABAN15MGBAYER PHARMA AG 51368 LEVERKUSEN-BAYER PHARMA AG 51368 LEVERKUSENGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X14.0 TABLET BLISTER01/07/2013
481NDA/MAL/HDP/0749AUROBINDO PHARMA LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDMEROGRAM 1000MEROPENEM1000MGAURONEXT PHARMA PVT LTD.-A- 1128 RIICO INDUSTRIAL AREA, PHASE III, DISTALWAR, BHIWADI INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0 G VIAL01/07/2014
482NDA/MAL/HDP/0750BAYER PHARMASURGIPHARM (U) LIMITEDXARELTO 20MGRIVAROXABAN20MGBAYER PHARMA AG 51368 LEVERKUSEN-BAYER PHARMA AG 51368 LEVERKUSENGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X14.0 TABLET BLISTER01/07/2013
483NDA/MAL/HDP/0751MICRO LABS LIMITEDLABOREX UGANDA LIMITEDDOLOWINACECLOFENAC100MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2013
484NDA/MAL/HDP/0752FERRER INTERNACIONAL S.ALABOREX UGANDA LIMITEDNUCLEO C.M.P FORTECYTIDINE + URIDINE10MG + 6MGFERRER INTERNACIONAL S.A --GRAN VIA CARLOS III 94 08028 BARCELONASPAINPARENTERAL ORDINARY DRY PRE-FILLED PENS1.0X3.0 ML AMPOULE + 1 *2ML CLEAR GLASS AMPOULES FOR SOLVENT07/01/15
485NDA/MAL/HDP/0753AUROBINDO PHARMA LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDMEROGRAM 500MEROPENEM500MGAURONEXT PHARMA PRIVATE LIMITED,-A-1128, RIICO INDUSTRIAL AREA, PHASE-III,BHIWADI-301019, DISTRICT- ALWAR (RAJASTHAN), INDIA. INDIAPARENTERAL ORDINARY DRY VIALS1.0X500.0 MG VIAL01/07/2014
486NDA/MAL/HDP/0754DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDTORAS DENK 10TORASEMIDE10MGDENK PHARMA GMBH &CO.KG--PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANY GERMANYORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2015
487NDA/MAL/HDP/0755TROIKAA PHARMACEUTICALS LIMITEDABACUS PHARMA (AFRICA) LIMITEDT- DOLTRAMADOL HYDROCHLORIDE50MG/MLTROIKAA PHARMACEUTICALS LIMITED..-THOL, DIST MEHSANA PIN 382728, GUJARAT INDIAPARENTERAL ORDINARY AMPOULES1.0X5.0X2.0 ML AMPOULE01/07/2014
488NDA/MAL/HDP/0756CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDTOLFREE 100TOLPERISONE100MGCADILA HEALTHCARE LIMITED -KUNDAIM INDUSTRIAL ESTATE,PLOT NO.203-213, KUNDAIM GOA, 403115, INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2014
489NDA/MAL/HDP/0757CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDTOLFREE 150TOLPERISONE150MGCADILA HEALTHCARE LIMITED -KUNDAIM INDUSTRIAL ESTATE,PLOT NO.203-213, KUNDAIM GOA, 403115, INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2014
490NDA/MAL/HDP/0759MICRO LABS LTDPHARMA VILLE LIMITEDCOTRIMOXAZOLECOTRIMOXAZOLE960MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER01/07/2011
491NDA/MAL/HDP/0760STRIDES PHARMASUPER PHARMACEUTICALS LIMITEDCEFAXCEFTRIAXONE1GREYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100 CHINAPARENTERAL ORDINARY DRY VIALS1.0X10.0X1.0 G VIAL01/07/2013
492NDA/MAL/HDP/0761BEIJING HOLLEY COTEC PHARMA CHINASUPER PHARMACEUTICALS LIMITEDBENZILINBENZATHINE BENZYLPENICILLIN 2.4MEGA/VIALREYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100 CHINAPARENTERAL ORDINARY DRY VIALS1.0X50.0X2.4 MU VIAL07/01/13
493NDA/MAL/HDP/0764UNICHEM LABORATORIES LTDEUROPA HEALTHCARE (U) LTDCORVADIL 5AMLODIPINE5MGUNICHEM LABORATORIES LIMITED UNIT II-VILLAGE BHATAULI KALAN BADDI DIST SOLAN HIMACHAL PRADESH 173 205INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET STRIP07/01/11
494NDA/MAL/HDP/0765PHARM ACCESS AFRICA LTDUNITED HEALTHCARE DISTRIBUTORS LTDLEVOPLANTLEVONORGESTREL75MGSHANGHAI DAHUA PHARMACEUTICAL CO. LTD-CHANG ZENG FARM, CHONGMING COUNTY, SHANGHAI CHINAPARENTERAL RETARD IMPLANTS1.0X10.0X2.0 ROD IMPLANT07/01/10
495NDA/MAL/HDP/0768FDC LTDAIVEEN (U) LIMITEDPYRIMON EYE DROPDEXAMETHASONE/CHLORAMPHENICOL1%W/V + 0.1%W/VFDC LIMITED -B-8, M.I.D.C., INDUSTRIAL AREA, WALUJ – AURANGABAD- 431 136 MAHARASHTRA, INDIA. INDIAOPHTHALMIC DROPS1.0X5.0 ML BOTTLE07/01/99
496NDA/MAL/HDP/0769BEIJING HOLLEY COTEC PHARMA CHINASUPER PHARMACEUTICALS LIMITEDAMPIL-1000AMPICILLIN1GREYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100 CHINAPARENTERAL ORDINARY DRY VIALS1.0X50.0 VIAL CARTON01/07/2013
497NDA/MAL/HDP/0770BEIJING HOLLEY COTEC PHARMA CHINASUPER PHARMACEUTICALS LIMITEDAMPIL-500AMPICILLIN500MGREYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100 CHINAPARENTERAL ORDINARY DRY VIALS1.0X50.0X500.0 MG VIAL01/07/2013
498NDA/MAL/HDP/0772MEGA LIFESCIENCES (AUSTRALIA) PTY LTDABACUS PHARMA (AFRICA) LIMITEDLIGABA - 150PREGABALIN150MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER07/01/14
499NDA/MAL/HDP/0774CADILA PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.NODONNEBIVOLOL10MGCADILA HEALTH CARE LIMITED -PLOT 203-213, KUNDAIM INDUSTRIAL ESTATE, GOA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X1.0X10.0 TABLET BLISTER01/07/2012
500NDA/MAL/HDP/0775MEGA LIFESCIENCES (AUSTRALIA) PTY LTDABACUS PHARMA (AFRICA) LIMITEDLIGABA - 75PREGABALIN75MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER07/01/14
501NDA/MAL/HDP/0776FREDUN PHARMACEUTICALS LTDPLANET PHARMACEUTICALS UGANDA LTDFREMOL TABLETSPARACETAMOL TABLETS500MGFREDUN PHARMACEUTICALS LTD-14,15,16 ZORBIAN INDUSTRIAL COMPLEX VEOOR PALGHAR EAST INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER01/07/1999
502NDA/MAL/HDP/0780CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDATORVA TABLETSATORVASTATIN10MGCADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X5.0X1.0X7.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER07/01/01
503NDA/MAL/HDP/0781TRIVENI FORMULATIONS LIMITEDAIVEEN (U) LIMITEDTRICOLDPARACETAMOL/PHENYLEPHRINE HYDROCHLORIDE/CAFFEINE ANHYDROUS/CHLORPHENIRAMINE500MG/10MG/30MG/2MGTRIVENI FORMULATIONS LIMITED --PLOT NO 52-54,62-64 ALEAP INDUSTRIAL ESTATE SURAMPALLI (V) VIJAYAWADA A.P INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X50.0X4.0 TABLET BLISTER01/07/2013
504NDA/MAL/HDP/0783TRIVENI FORMULATIONS LIMITEDAIVEEN (U) LIMITEDCYPOLIVECYPROHEPTADINE HYDROCHLORIDE4 MGTRIVENI FORMULATIONS LIMITED--PLOT NO: 52,53,54, 62,63 & 64 ALEAP INDUSTRIAL ESTATE SURAMPALI VILLAGE, GANNAVARAM MANDAL KRISHNA (DT) A.P INDIAORAL SOLID ORDINARY TABLETS1.0X2.0X50.0 TABLET BLISTER01/07/2013
505NDA/MAL/HDP/0784COSMOS LTDASTRA PHARMA (U) LIMITEDHEMOSANFERROUS FUMERATE300MGCOSMOS LIMITED, KENYA-RANGWE ROAD, OFF LUNGA ROAD, INDUSTRIAL AREA
NAIROBI - KENYA
KENYAORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER01/07/2013
506NDA/MAL/HDP/0788TRIVENI FORMULATIONS LIMITEDAIVEEN (U) LIMITEDTRIDANTINNITROFURANTOIN100 MGTRIVENI FORMULATIONS LIMITED .- PLOT NO 52,53-54,63-64 ALEAP INDUSTRIAL ESTATE SURAMPALLI VILLAGE GANNAVARAN MANDAL KRISHNA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2013
507NDA/MAL/HDP/0792ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDAS-VPHENOXYMETHYL PENICILLIN250MGASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET STRIP01/07/2010
508NDA/MAL/HDP/0795AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOPEN-250PHENOXYMETHYL PENICILLIN POTASSIUM250MGMILAN LABORATORIES (INDIA) PVT LTD .-PLOTS 63,67,87,35,36,64,65, JAWAHAR CO-OP IND. ESTATE LTD, KAMOTHE, PANVEL (NAVI MUMBAI) INDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER01/07/2013
509NDA/MAL/HDP/0796HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDAMLO-H 5AMLODIPINE BESILATE5MGHETERO LABS LTD. UNIT (V) .-S.N0.439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE), JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA. INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2013
510NDA/MAL/HDP/0797NVS KENYA LTDSURGIPHARM (U) LIMITEDAFINITOR 5MGEVEROLIMUS5MGNORVATIS PHARMA STEIN AG-SCHAFF HAUSER STRASSE 4332, STEIN - SWITZERLAND SWITZERLANDORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET BLISTER01/07/2015
511NDA/MAL/HDP/0798HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDAMLO-H 10AMLODIPINE BESILATE10MGHETERO LABS LTD (UNIT-V)-SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2013
512NDA/MAL/HDP/0799NVS KENYA LTDSURGIPHARM (U) LIMITEDAFINITOR 10MGEVEROLIMUS10MGNORVATIS PHARMA STEIN AG-SCHAFF HAUSER STRASSE 4332, STEIN - SWITZERLAND SWITZERLANDORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET BLISTER01/07/2015
513NDA/MAL/HDP/0802NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDEXFORGE HCT 5MG/ 160MG/12.5MGAMLODIPINE + VALSARTAN + HYDROCHLOROTHIAZIDE5MG+ 160MG+ 12.5MGNOVARTIS PHARMA STEIN AG-SCHAFFHARVSERTRASSE CH-4332 STEIN SWITZERLAND. NOVARTIS FARMACEUTICA SA-RONDA DE SANTA MARIA,158, E-08210 BARBERA DEL VALLES BARCELONA SPAIN SWITZERLANDORAL SOLID ORDINARY FILM-COATED TABLETS1.0X4.0X7.0 TABLET BLISTER01/07/2015
514NDA/MAL/HDP/0806SQUARE PHARMACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDSQUARE ZINCZINC SULPHATE20MGSQUARE PHARMACEUTICALS LIMITED-KALIAKOIR GAZIPUR – 1750, BANGLADESH BANGLADESHORAL SOLID ORDINARY SOLUBLE TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2013
515NDA/MAL/HDP/0808PIRAMAL HEALTHCARE LTDTATA UGANDA LIMITEDISOFLURANEISOFLURANE250MLPIRAMAL ENTERPRISES LTD, INDIA-DIGWAL VILLAGE KOHIR MENDAL MEDAK DISTRICT,ANDHRA PRADESH INDIAOTHER SYSTEMIC LIQUID INHALATIONS1.0X250.0 ML BOTTLE,1.0X100.0 ML BOTTLE01/07/2005
516NDA/MAL/HDP/0809BRICVED LTDBOOTS PHARMACEUTICALS LIMITEDPARAPAEDPARACETAMOL120MG/5MLPINEWOOD LABORATORIES LTD-BALLYMACARBRY, CLONMEL, TIPPERARY, IRELAND IRELANDORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE01/07/2013
517NDA/MAL/HDP/0811MICRO LABS LIMITEDLABOREX UGANDA LIMITEDDOLOWIN -SRACECLOFENAC200MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2013
518NDA/MAL/HDP/0812BRICVED LTDBOOTS PHARMACEUTICALS LIMITEDFENPAEDIBUPROFEN100MG/5MLPINEWOOD LABORATORIES LTD-BALLYMACARBRY, CLONMEL, TIPPERARY, IRELAND IRELANDORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE01/07/2013
519NDA/MAL/HDP/0816DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDGLIMEPIRIDE DENK 2GLIMEPIRIDE2MGDENK PHARMA GMBH & CO. KG -GOLLSTR. 1 84529 TITTMONINGGERMANYORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2012
520NDA/MAL/HDP/0820MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDFIXIME 400MGCEFIXIME400MGNKUNZI PHARMACEUTICALS-259 DAVIDSON ROAD, WADEVILLEGERMISTON, 1428 SOUTH AFRICA SOUTH AFRICAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X5.0 TABLET BLISTER,1.0X1.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER01/07/2015
521NDA/MAL/HDP/0821DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDGLIMEPIRIDE DENK 3GLIMEPIRIDE3MGDENK PHARMA GMBH & CO. KG -GOLLSTR. 1 84529 TITTMONINGGERMANYORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2012
522NDA/MAL/HDP/0822ABACUS PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDCLOXCIN-500CLOXACILLIN SODIUM500MGREYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100 CHINAPARENTERAL ORDINARY DRY VIALS1.0X50.0X1.0 G VIAL01/07/2014
523NDA/MAL/HDP/0823CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDTRAP TABLETSTRAMADOL HCL + PARACETAMOL37.5MG+325MGCADILA HEALTHCARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO.203-213, KUNDAIM GOA, 403115, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2013
524NDA/MAL/HDP/0824I CARE PHARMA LIMITEDVITACARE LTDCLOXACILLINCLOXACILLIN250MGREYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100 INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER01/07/2013
525NDA/MAL/HDP/0826I CARE PHARMA LIMITEDVITACARE LTDAMOXYCILLINAMOXYCILLIN250MGREYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100 INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER01/07/2013
526NDA/MAL/HDP/0827GALPHA LABORATORIES LTDAIVEEN (U) LIMITEDCLANOXY 1.2AMOXICILLIN + CLAVULANATE1000 MG + 200 MGGALPHA LABORATORIES LTD-AT: ALKEM LABORATORIES LTD PLOT 167/2 MAHATMA UDYOG NAGAR AMALIYA DAMAN 396210INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0 ML VIAL 1*20ML VIAL OF WFI01/07/2015
527NDA/MAL/HDP/0830MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDEUTHYROX 25 MCGLEVOTHYROXINE SODIUM25 MCGMERCK KGAA - -FRANKFRUTER STRASSE 250, D-64293,DARMSTADT- GERMANY GERMANYORAL SOLID ORDINARY TABLETS1.0X1.0X30.0 TABLET BLISTER,1.0X4.0X25.0 TABLET BLISTER07/01/15
528NDA/MAL/HDP/0831I CARE PHARMA LIMITEDVITACARE LTDAMPICILLIN CAPSULESAMPICILLIN250MGREYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100 CHINAORAL SOLID ORDINARY OTHER CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER01/07/2013
529NDA/MAL/HDP/0832MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDEUTHYROX 100MCGLEVOTHYROXINE100MCGMERCK KGAA - -FRANKFRUTER STRASSE 250, D-64293,DARMSTADT- GERMANY GERMANYORAL SOLID ORDINARY TABLETS1.0X4.0X25.0 TABLET BLISTER,1.0X1.0X30.0 TABLET BLISTER07/01/15
530NDA/MAL/HDP/0834LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDVOMI-6DOXYLAMINE SUCCINATE & PYRIDOXINE HYDROCHLORIDE10MG + 10MGLINCOLN PHARMACEUTICALS LIMITED.-TRIMUL ESTATE NEAR KHATRAJ CHOKADI KHATRAJ 382721 GHANDHINAGAR GUJARATINDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X10.0X1.0X10.0 TABLET BLISTER01/07/2013
531NDA/MAL/HDP/0835AGOG PHARMA LTD.GITTOES PHARMACEUTICALS LIMITEDAGOBISBISACODYL5MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER01/07/2013
532NDA/MAL/HDP/0836LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDCALBONE-500CALCIUM CARBONATE + COLECALCIFEROL1250MG + 250 I.ULINCOLN PHARMACEUTICALS LIMITED -10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER01/07/2012
533NDA/MAL/HDP/0841MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDETHOMIDETHIONAMIDE250MGMACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET STRIP01/07/2013
534NDA/MAL/HDP/0842LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDSACSECNIDAZOLE1000MGLINCOLN PHARMACEUTICALS LIMITED -10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X2.0 TABLET BLISTER01/07/2013
535NDA/MAL/HDP/0843MACLEODS PHARMACEUTICAL LTDNORVIK ENTERPRISES LIMITEDCOXERINCYCLOSERINE250MGMACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIAINDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE STRIP01/07/2013
536NDA/MAL/HDP/0845VIRBAC RSA (PTY) LTDMETRO PHARMACEUTICALS LIMITEDOLEVO-500LEVOFLOXACIN500 MGLINCOLN PHARMACEUTICALS LIMITED -10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X5.0X10.0 TABLET BLISTER01/07/2013
537NDA/MAL/HDP/0846MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDMOXIMACMOXIFLOXACIN400MGMACLEODS PHARMACEUTICALS LTD--PLOT 25-27 SURVEY NO. 366 PREMIER INDUSTRIAL ESTATE KACHIGAM DAMANINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X5.0 TABLET BLISTER01/07/2014
538NDA/MAL/HDP/0848MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDMACROZIDE 500PYRAZINAMIDE500MGMACLEODS PHARMACEUTICALS LTD---PLOT NO 25-27 SURVEY PREMEIRE INDUSTRIAL ESTATE KACHIGAM DAMAN (U.T) 396401INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CONTAINER01/07/2014
539NDA/MAL/HDP/0850LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDLCT KITLANSOPRAZOLE + CLARITHROMYCIN + TINIDAZOLE30MG + 250MG + 500MGLINCOLN PHARMACEUTICALS LIMITED -10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X7.0X1.0X6.0 TABLET BLISTER (BLISTER CONTAINS 2 CAPSULES AND 4 TABLETS)01/07/2012
540NDA/MAL/HDP/0852MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDKAPOCIN-1GCAPREOMYCIN1000MGMACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIAINDIAPARENTERAL ORDINARY DRY VIALS1.0X50.0 VIAL CARTON01/07/2013
541NDA/MAL/HDP/0854GLENMARK PHARMACUTICALS LTDSTAR PHARMACEUTICALS LTDIBICAR-50BECLOMETASONE50MCG PER ACTUATIONGLENMARK PHARMACEUTICALS LTD (UNIT III).-UNIT III VILLAGE KISHANPURA,BADDI-NALAGARH ROAD TEHSIL BADDI,DISTT. SOLAN, HIMACHAL PRADESH -173 205 INDIA
INDIALUNG ADMINISTRATION METERED-DOSE INHALER1.0X200.0 METERED DOSE CANNISTER01/07/2013
542NDA/MAL/HDP/0855HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDLAZINELEVOCETIRIZINE DIHYDROCHLORIDE5MGHETERO LABS LTD-22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESHINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2013
543NDA/MAL/HDP/0856MACLEODS PHARMACEUTICAL LTDNORVIK ENTERPRISES LIMITEDKANAMAC-1000KANAMYCIN1GMACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIAINDIAPARENTERAL ORDINARY DRY VIALS1.0X50.0X1000.0 MG VIAL01/07/2013
544NDA/MAL/HDP/0857GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDCANDID-V6 VAGINAL TABLETSCLOTRIMAZOLE100MGGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D INDIAVAGINAL TABLETS1.0X6.0 PESSARY STRIP01/07/2000
545NDA/MAL/HDP/0858ASTRAZENECAMACNAUGHTON LIMITEDPLENDILFELODIPINE5MGASTRAZENECA AB,-GARTUNA & SNACKVIKEN STOCKHOLM SWEDENORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET CONTAINER01/07/2001
546NDA/MAL/HDP/0860MSN LABORATORIES LTDMETRO PHARMACEUTICALS LIMITEDFLOXSAFE 400MOXIFLOXACIN HYDROCHLORIDE400MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X5.0 TABLET BLISTER01/07/2012
547NDA/MAL/HDP/0861SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDPROZINEPROMETHAZINE25MG/MLSAKAR HEALTHCARE PVT. LTD-PLOT 10/13 SAKHEJ-BAVLA ROAD, AHMEDABAD,GUJURAT,INDIA INDIAPARENTERAL ORDINARY AMPOULES2.0X5.0X2.0 ML AMPOULE01/07/2013
548NDA/MAL/HDP/0862GLENMARK PHARMACUTICALS LTDSTAR PHARMACEUTICALS LTDIBICAR- 200BECLOMETASONE200MCG PER ACTUATIONGLENMARK PHARMACEUTICALS LTD (UNIT III).-UNIT III VILLAGE KISHANPURA,BADDI-NALAGARH ROAD TEHSIL BADDI,DISTT. SOLAN, HIMACHAL PRADESH -173 205 INDIA
INDIALUNG ADMINISTRATION METERED-DOSE INHALER1.0X200.0 METERED DOSE CANNISTER01/07/2013
549NDA/MAL/HDP/0864HETERO LABS LTD UNIT IXAIVEEN (U) LIMITEDPANTIN-40PANTOPRAZOLE SODIUM40 MGHETERO LABS LIMITED UNIT V-APIIC PHARMA SEZ, S. NO. 439, 440, 441 & 458 POLEPALLY VILLAGE, JADCHERLA MANDAL, MAHABOOBNAGAR (DISTRICT). PIN 509301 INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2013
550NDA/MAL/HDP/0866GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDLIZOLIDLINEZOLID2MG/MLAMANTA HEALTHCARE LIMITED-PLOT NO. 876 N.H. NO. 8 VILLAGE-HIRIYALA TALUKA, MATAR, DIST KHEDA-387 411, GUJARAT INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X300.0 ML BOTTLE,1.0X100.0 ML BOTTLE01/07/2013
551NDA/MAL/HDP/0867HETERO LABS LTD UNIT IXAIVEEN (U) LIMITEDPANTIN-20PANTOPRAZOLE SODIUM20MGHETERO LABS LIMITED UNIT V-APIIC PHARMA SEZ, S. NO. 439, 440, 441 & 458 POLEPALLY VILLAGE, JADCHERLA MANDAL, MAHABOOBNAGAR (DISTRICT). PIN 509301 INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2013
552NDA/MAL/HDP/0868SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDVARMIKA-500AMIKACIN500MGSAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIA INDIAPARENTERAL ORDINARY AMPOULES1.0X2.0X5.0X2.0 ML AMPOULE01/07/2013
553NDA/MAL/HDP/0869SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDLARTRMARTEMETHER80MG/MLSAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIA INDIAPARENTERAL ORDINARY I M AMPOULES1.0X6.0X1.0 ML AMPOULE01/07/2013
554NDA/MAL/HDP/0870TROIKAA PHARMACEUTICALS LIMITEDABACUS PHARMA (AFRICA) LIMITEDTROY-KPHYTOMENADIONE10MG/MLTROIKAA PHARMACEUTICALS LIMITED-THOL, DIST. MEHSANA-382728, GUJARAT,INDIA INDIAPARENTERAL ORDINARY AMPOULES1.0X10.0X1.0 ML AMPOULE01/07/2010
555NDA/MAL/HDP/0871SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDDEXADEXAMETHASONE SODIUM4MG/MLSAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIA INDIAPARENTERAL ORDINARY DRY VIALS2.0X6.0X2.0 ML VIAL01/07/2013
556NDA/MAL/HDP/0873GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDOXYTOCIN INJECTIONOXYTOCIN10I.U/MLNINGBO DAHONGYING PHARMACEUTICAL CO LTD-NO 396, MINGZHU ROAD NINGBO CITY CHINA CHINAPARENTERAL ORDINARY AMPOULES1.0X10.0X1.0 ML AMPOULE01/07/2009
557NDA/MAL/HDP/0874LEBEN LABORATORIES PVT LTDANDYCO PHARMACY (UGANDA) LTDLEBASMA-4SALBUTAMOL4MGLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL SOLID ORDINARY TABLETS1.0X20.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER01/07/2014
558NDA/MAL/HDP/0877LEBEN LABORATORIES LTDANDYCO PHARMACY (UGANDA) LTDANTAGIT DS GEL MINT FLAVOURDRIED ALUMINIUM HYDROXIDE + MAGNESIUM HYDROXIDE + SIMETHICONE400MG + 400MG + 50MGLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X1.0X170.0 ML BOTTLE01/07/2007
559NDA/MAL/HDP/0879COSMOS LTD.ASTRA PHARMA (U) LIMITEDTRIBEES FORTE FILM COATED TABLETSTHIAMINE + PYRIDOXINE + CYANOCOBALAMIN200MG + 50MG +1000MCGCOSMOS LIMITED, KENYA-RANGWE ROAD, OFF LUNGA ROAD, INDUSTRIAL AREA
NAIROBI - KENYA
KENYAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X10.0 TABLET BLISTER07/01/12
560NDA/MAL/HDP/0882MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDGLUCOVANCE 500MG/2.5MGMETFORMIN + GLIBENCLAMIDE500MG + 2.5MGMERCK SANTE S.A.S-CENTRE DE PRODUCTION DE SEMOY 2 RUE DU PRESSIOR VERT 45400 SEMOYFRANCEORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X15.0 TABLET BLISTER,1.0X4.0X15.0 TABLET BLISTER01/07/2012
561NDA/MAL/HDP/0883MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDGLUCOVANCE 500MG/5MGMETFORMIN + GLIBENCLAMIDE500MG + 5MGMERCK SANTE S.A.S-CENTRE DE PRODUCTION DE SEMOY 2 RUE DU PRESSIOR VERT 45400 SEMOYFRANCEORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X15.0 TABLET BLISTER,1.0X4.0X15.0 TABLET BLISTER01/07/2012
562NDA/MAL/HDP/0889PHARMACIE BETHELABACUS PARENTERAL DRUGS LIMITEDDNSSODIUM CHLORIDE + GLUCOSE0.9%W/V + 5% W/VABACUS PARENTERAL DRUGS LIMITED-BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA. UGANDAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X250.0 ML BOTTLE,1.0X500.0 ML BOTTLE01/07/2012
563NDA/MAL/HDP/0892ASTRA ZENECAMACNAUGHTON LIMITEDONGLYZASAXAGLIPTIN2.5MGBRISTOL-4601 HIGHWAY 62 EAST MOUNT VERNON INDIANA 47620
USA
UNITED STATESORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET CONTAINER01/07/2013
564NDA/MAL/HDP/0894HETERO LABS LTDAIVEEN (U) LIMITEDGIAGRA 100SILDENAFIL CITRATE100MGHETERO LABS LTD. UNIT (V)-439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE),
JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA.
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X4.0X10.0 TABLET BLISTER01/07/2014
565NDA/MAL/HDP/0895VIRCHOW HEALTHCARE PVT LTDSURGIPHARM (U) LIMITEDHYORTHSODIUM HYALURONATE10MG/1MLVIRCHOW BIOTECH PVT, LTD-SURVEY NO. 172, PART GAGILLAPUR, QUTHBULLAPUR, R.R, DIST INDIAPARENTERAL ORDINARY PRE-FILLED SYRINGES1.0X2.0 ML PRE- FILLED SYRINGE01/07/2015
566NDA/MAL/HDP/0897VIRCHOW HEALTHCARE PVT LTDSURGIPHARM (U) LIMITEDDEBRIDACEPAPAIN + UREA521700UNITS+100MG/GVIRCHOW BIOTECH PVT, -SURVEY NO. 172, PART GAGILLAPUR, QUTHBULLAPUR, R.R, DISTRICT TELANGANA INDIATOPICAL EXTERNAL OINTMENTS1.0X15.0 G TUBE01/07/2015
567NDA/MAL/HDP/0898HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDLOSAGEN 50LOSARTAN POTASSIUM50MGHETERO LABS LTD (UNIT-V)-SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2013
568NDA/MAL/HDP/0899VIRCHOW HEALTHCARE PVT LTDSURGIPHARM (U) LIMITEDVIRIAXONECEFTRIAXONE1GINJECTCARE PARENTERALS PVT. LTD.-PLOT130 SILVASSA ROAD GIDC VAPI 396195 GUJARATINDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0 G VIAL + 10 ML VIAL WFI07/01/13
569NDA/MAL/HDP/0900ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDLAPSONEDAPSONE100MGASTRA LIFECARE (INDIA) PVT. LTD-PLOT 57/P, SARKHEJ-BAVLA HIGHWAY, RAJODA 382 220, AHMEDABAD, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER01/07/2013
570NDA/MAL/HDP/0902AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOPINE SRNIFEDIPINE20MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID RETARD FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2013
571NDA/MAL/HDP/0903GLAXO WELLCOME(KENYA) LTDUNITED HEALTHCARE DISTRIBUTORS LTDZANTACRANITIDINE50MG/2MLGLAXO SMITHKLINE MANUFACTURING S.P.A .-STARDA PROVINCIALE ASOLANA 90, 43056 SAN POLO DI TORRILE (PARMA) ITALYPARENTERAL ORDINARY AMPOULES1.0X2.0 ML AMPOULE01/07/1997
572NDA/MAL/HDP/0904ASTRA ZENECAMACNAUGHTON LIMITEDONGLYZASAXAGLIPTIN5MGBRISTOL-4601 HIGHWAY 62 EAST MOUNT VERNON INDIANA 47620
USA ASTRA ZENECA UK LIMITED-ASTRAZENECA UK LIMITED SILK ROAD BUSINESS PARK, MACCLES FIELD,CHESHIRE SK 10 2NA,
UNITED STATESORAL SOLID ORDINARY FILM-COATED TABLETS1.0X30.0 TABLET CONTAINER
573NDA/MAL/HDP/0905NECTAR LIFESCIENCES LTDAIVEEN (U) LIMITEDNECPODCEFPODOXIME PROXETIL200MGNECTAR LIFESCIENCES LTD UNIT VI-BHATOLIKALAN P.O BAROTIWALA DISTT SOLAN HIMACHAL PRADESH 173205INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET STRIP01/07/2013
574NDA/MAL/HDP/0906VIRCHOW HEALTHCARE PVT LTDSURGIPHARM (U) LIMITEDIONSILSILVER NITRATE0.2%W/WVIRCHOW BIOTECH PVT, -SURVEY NO. 172, PART GAGILLAPUR, QUTHBULLAPUR, R.R, DISTRICT TELANGANA INDIATOPICAL EXTERNAL GELS AND SOLS1.0X15.0 G TUBE01/07/2015
575NDA/MAL/HDP/0907NECTAR LIFESCIENCES LTDAIVEEN (U) LIMITEDCEFUAXITCEFUROXIME AXETIL250MGNECTAR LIFE SCIENCES LTD--UNIT VI BHATOLIKALAN DIST SOLAN H.PINDIAORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET STRIP01/07/2013
576NDA/MAL/HDP/0908VIRCHOW HEALTHCARE PVT LTDSURGIPHARM (U) LIMITEDHYOPT PLUSSODIUM HYALURONATE11.9MG/0.85MLVIRCHOW BIOTECH PVT, -SURVEY NO. 172, PART GAGILLAPUR, QUTHBULLAPUR, R.R, DISTRICT TELANGANA INDIAPARENTERAL ORDINARY PRE-FILLED SYRINGES1.0X0.85 ML PRE- FILLED SYRINGE01/07/2015
577NDA/MAL/HDP/0909NECTAR LIFESCIENCES LTDAIVEEN (U) LIMITEDFIXINECTCEFIXIME100MGNECTAR LIFESCIENCES LTD UNIT VI-BHATOLIKALAN P.O BAROTIWALA DISTT SOLAN HIMACHAL PRADESH 173205INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET STRIP01/07/2013
578NDA/MAL/HDP/0911VIRCHOW HEALTHCARE PVT LTDSURGIPHARM (U) LIMITEDHEALACERECOMBINANT HUMAN PLATELET DERIVED GROWTH FACTOR -B100MCG/GVIRCHOW BIOTECH PVT, LTD-SURVEY NO. 172, PART GAGILLAPUR, QUTHBULLAPUR, R.R, DIST INDIATOPICAL EXTERNAL GELS AND SOLS1.0X15.0 G TUBE01/07/2015
579NDA/MAL/HDP/0913NOVARTIS PHARMASURGIPHARM (U) LIMITEDFEMARALETROZOLE2.5MGNORVATIS PHARMA STEIN AG-SCHAFF HAUSER STRASSE 4332, STEIN - SWITZERLAND SWITZERLANDORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2013
580NDA/MAL/HDP/0914VIRCHOW HEALTHCARE PVT LTDSURGIPHARM (U) LIMITEDOSTEOTIDETERIPARATIDE [RECOMBINANT HUMAN PARATHYROID HORMONE (1-34)] INJECTION250MCG/MLVIRCHOW BIOTECH PVT LTD -SURVEY NO. 172, PART GAGILLAPUR, QUTHBULLAPUR, R.R, DISTRICT ANDHRA PRADESH INDIAPARENTERAL ORDINARY AMPOULES1.0X3.0 ML VIAL01/07/2015
581NDA/MAL/HDP/0915NOVARTIS PHARMA SERVICES INCSURGIPHARM (U) LIMITEDCURAMAMOXICILLIN + CLAVULANIC ACID875 MG + 125 MGSANDOZ GMBH-BIOCHEMIESTRASSE 10, A6250 KUNDL, TYROL, AUSTRIA AUSTRIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X7.0X2.0 TABLET STRIP01/07/2014
582NDA/MAL/HDP/0920TROIKAA PHARMACEUTICALS LIMITEDABACUS PHARMA (AFRICA) LIMITEDBUPITROY HEAVYBUPIVACAINE HYDROCHLORIDE5MG/ML TROIKAA PHARMACEUTICALS LTD .-SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHAND, INDIA INDIAPARENTERAL ORDINARY VIALS1.0X5.0X4.0 ML VIAL01/07/2012
583NDA/MAL/HDP/0926MICRO LABS LIMITEDLABOREX UGANDA LIMITEDBACTOCLAV-375AMOXICILLIN +CLAVULANATE POTASSIUM250MG + 125MGMICRO LABS LIMITED.-PLOT 16, VEERASANDRA IND. AREA,ANEKAL TALUK, BANGALORE INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X6.0 TABLET STRIP,1.0X2.0X10.0 TABLET STRIP01/07/2004
584NDA/MAL/HDP/0928AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDINSTACLOP 75CLOPIDOGREL75MGAJANTA PHARMA LTD--B-4/5/6 MIDC INDUSTRIAL AREA PAITHAN 431 128 AURANGABADINDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET STRIP01/07/2013
585NDA/MAL/HDP/0929IPCA LABORATORIES LTDMEDVIN PHARMA LIMITEDDUOQUINDIHYDROARTEMISININ + PIPERAQUINE PHOSPHATE40MG +320MG IPCA LABORATORIES LTD-PLOT NO. 255/1,
VILLAGE ATHAL,
SILVASSA-396230,
DADRA AND NAGAR HAVELI, INDIA.
INDIAORAL SOLID ORDINARY TABLETS10.0X1.0X9.0 TABLET BLISTER,10.0X1.0X8.0 TABLET BLISTER01/07/2012
586NDA/MAL/HDP/0931LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDARH JUNIORALPHA-BETA ARTEETHER75MG/MLSAKAR HEALTHCARE PVT. LTD-PLOT 10/13 SAKHEJ-BAVLA ROAD, AHMEDABAD,GUJURAT,INDIA INDIAPARENTERAL ORDINARY AMPOULES1.0X3.0X1.0 ML AMPOULE01/07/2012
587NDA/MAL/HDP/0934CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDODIMONT 4MONTELUKAST4MGCADILA HEALTHCARE LTD SARKHEJ-BAVLA NH NO.8A MORAIYA TAL SANAND DISTRICT AHMEDABAD 382210INDIAORAL SOLID ORDINARY CHEWABLE COATED TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2011
588NDA/MAL/HDP/0937CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDVALAZYD H 92.5VALSARTAN/HYDROCHLOROTHIAZIDE80MG/12.5MGCADILA HEALTH CARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER07/01/12
589NDA/MAL/HDP/0939LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDARHALPHA -BETA ARTEETHER150MG /2MLSAKAR HEALTHCARE PVT. LTD-PLOT 10/13 SAKHEJ-BAVLA ROAD, AHMEDABAD,GUJURAT,INDIA INDIAPARENTERAL ORDINARY AMPOULES1.0X3.0X2.0 ML AMPOULE01/07/2012
590NDA/MAL/HDP/0941AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDZAHAAZITHROMYCIN200MG/5MLAJANTA PHARMA LIMITED-31-0 MIDC INDUSTRIAL AREA CHIKALTHANA 431210 DIST AURANGABAD MAHARASHTRA STATEINDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X15.0 ML BOTTLE01/07/2013
591NDA/MAL/HDP/0942LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDARH FORTEALPHA -BETA ARTEETHER225MG/ 3MLSAKAR HEALTHCARE PVT. LTD-PLOT 10/13 SAKHEJ-BAVLA ROAD, AHMEDABAD,GUJURAT,INDIA INDIAPARENTERAL ORDINARY AMPOULES1.0X3.0X3.0 ML AMPOULE01/07/2012
592NDA/MAL/HDP/0943MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDSTREPTOMYCIN INJECTION BPSTREPTOMYCIN1GMACLEODS PHARMACEUTICALS LTD--PLOT 25-27 SURVEY NO. 366 PREMIER INDUSTRIAL ESTATE KACHIGAM DAMANINDIAPARENTERAL ORDINARY DRY VIALS1.0X100.0X1.0 G VIAL01/07/2013
593NDA/MAL/HDP/0945CLARIS LIFE SCIENCES LIMITEDREDDYS PHARMA LIMITEDZOFEXOFLOXACIN2 MG/MLCLARIS OTSUKA LIMITED-VILLAGE – VASANA – CHACHARWADIP,
TAL: SANAND, AHMADABAD
INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X100.0 ML BOTTLE01/07/2013
594NDA/MAL/HDP/0946ASTRAZENECAMACNAUGHTON LIMITEDTENORETICATENOLOL + CHLORTHALIDONE100 MG + 25 MGASTRA ZENECA UK LIMITED-SILK ROAD BUSINESS PARK,MACCLESFIELD,CHESHIRE SK 10 2NA, UNITED KINGDOMORAL SOLID ORDINARY FILM-COATED TABLETS1.0X14.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER01/07/1997
595NDA/MAL/HDP/0948COSMOS LTDASTRA PHARMA (U) LIMITEDLORHISTINA SYRUP 5MG/5MLLORATADINE5MG/5MLCOSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA KENYAORAL LIQUID ORDINARY LIQUIDS1.0X60.0 ML BOTTLE01/07/2013
596NDA/MAL/HDP/0951NEON LABARATORIES LTDAIVEEN (U) LIMITEDNORADSTERILE NORADRENALINE CONCENTRATE2MG/2MLNEON LABORATORIES LTD-PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROAD INDIAPARENTERAL ORDINARY S C AMPOULES1.0X5.0X2.0 ML AMPOULE01/07/2013
597NDA/MAL/HDP/0952NEON LABARATORIES LTDAIVEEN (U) LIMITEDEFECATALCEFTRIAXONE1GNEON LABORATORIES LTD-PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROAD INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0 G VIAL01/07/2013
598NDA/MAL/HDP/0953NEON LABARATORIES LTDAIVEEN (U) LIMITEDCIZCANCISPLATIN10MG/10MLNEON LABORATORIES LTD-PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROAD INDIAPARENTERAL ORDINARY VIALS1.0X10.0 ML VIAL01/07/2013
599NDA/MAL/HDP/0954NEON LABARATORIES LTDAIVEEN (U) LIMITEDANAWINBUPIVACAINE50MG/20MLNEON LABORATORIES LTD-PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROAD INDIAPARENTERAL RETARD OTHER VIALS1.0X20.0 ML VIAL01/07/2013
600NDA/MAL/HDP/0957MACK BROWN PHARMACEUTICALS PVT LIMITEDSHURIK LTDLYRED SYRUPVITAMINE A + VITAMINE E ACETATE + ASCORBIC ACID + SELENIUM + ZINC2500 IU + 10 IU + 50MG + 35MCG + 3MGTORQUE PHARMACEUTICALS PVT LTD-ISAAPUR P.O DAPPAR 140056 INDIAINDIAORAL LIQUID ORDINARY SYRUPS1.0X200.0 ML BOTTLE01/07/2012
601NDA/MAL/HDP/0959AJANTA PHARMA LTD 31-0ABACUS PHARMA (AFRICA) LIMITEDARTEFAN DISPERSIBLE 20/120ARTEMETHER + LUMEFANTRINE20MG + 120MGAJANTA PHARMA LIMITED PAITHAN-MANUFACTURING UNIT B-4/5/6 MIDC PAITHAN DISTRICT AURANGABAD 431 148 MAHARASTRA STATE INDIAINDIAORAL SOLID ORDINARY SOLUBLE TABLETS1.0X12.0 TABLET BLISTER,1.0X6.0 TABLET BLISTER,1.0X30.0X6.0 TABLET BLISTER,1.0X30.0X12.0 TABLET BLISTER07/01/13
602NDA/MAL/HDP/0962I CARE PHARMA LIMITEDVITACARE LTDFORTIFIED PROCAINE BENZYL PENICILLINFORTIFIED PROCAINE BENZYL PENICILLIN4MUREYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100 CHINAPARENTERAL ORDINARY I M VIALS1.0X4.0 MU VIAL01/07/2013
603NDA/MAL/HDP/0963AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDAPMODARTESUNATE+AMODIAQUINE50MG+135MGAJANTA PHARMA LTD--B-4/5/6 MIDC INDUSTRIAL AREA PAITHAN 431 128 AURANGABADINDIAORAL SOLID ORDINARY LAYERED TABLETS1.0X3.0 TABLET BLISTER01/07/2013
604NDA/MAL/HDP/0964AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDAPMOD 25 / 67.5ARTESUNATE + AMODIAQUINE25 MG + 67.5 MGAJANTA PHARMA LTD--B-4/5/6 MIDC INDUSTRIAL AREA PAITHAN 431 128 AURANGABADINDIAORAL SOLID ORDINARY LAYERED TABLETS1.0X1.0X3.0 TABLET BLISTER01/07/2013
605NDA/MAL/HDP/0966SQUARE PHARMACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDCLOFENAC DTDICLOFENAC SODIUM50MGSQUARE PHARMACEUTICALS LIMITED-KALIAKOIR GAZIPUR – 1750, BANGLADESH BANGLADESHORAL SOLID ORDINARY SOLUBLE TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2014
606NDA/MAL/HDP/0967I CARE PHARMA LIMITEDVITACARE LTDSTREPTOMYCINSTREPTOMYCIN1GREYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100 CHINAPARENTERAL ORDINARY VIALS1.0X10.0 VIAL CARTON01/07/2013
607NDA/MAL/HDP/0969EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDASOMEX-2.5AMLODIPINE BESILATE2.5MGEMCURE PHARMACEUTICALS LTD -LANE NO.3 PHASE II,SIDCO INDUSTRIAL COMPLEX,BARI-BRAHMANA JAMMU 181 133, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X5.0X10.0 TABLET BLISTER07/01/05
608NDA/MAL/HDP/0971I CARE PHARMA LIMITEDVITACARE LTDBENZYLPENICILLIN INJECTIONBENZYL PENICILLIN SODIUM1MUREYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100 CHINAPARENTERAL ORDINARY I M VIALS1.0X10.0 VIAL CARTON,1.0X50.0 VIAL CARTON01/07/2013
609NDA/MAL/HDP/0972PHARCO PHARMACEUTICALS COMPANY LTDECHO PHARMACY (U) LIMITEDAZOMYCINAZITHROMYCIN DIHYDRATE200 MG/5MLPHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT.
P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT
EGYPTORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X15.0 ML BOTTLE01/07/2013
610NDA/MAL/HDP/0974SQUARE CEPHALOSPORINS LTDGAMA PHARMACEUTICALS (U) LIMITEDCEF-3CEFIXIME100MG/5MLSQUARE CEPHALOSPORINS LTD-KALIAKOIR, GAZIPUR – 1750, BANGLADESH BANGLADESHORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X50.0 ML BOTTLE01/07/2015
611NDA/MAL/HDP/0975PHARCO PHARMACEUTICALSECHO PHARMACY (U) LIMITEDCETRAK SYRUPCETIRIZINE DIHYDROCHLORIDE5MG/5MLPHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT.
P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT
EGYPTORAL LIQUID ORDINARY SYRUPS1.0X120.0 ML BOTTLE01/07/2013
612NDA/MAL/HDP/0977PHARCO PHARMACEUTICALSECHO PHARMACY (U) LIMITEDCETRAKCETIRIZINE DIHYDROCHLORIDE10MGPHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT.
P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT
EGYPTORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER01/07/2013
613NDA/MAL/HDP/0980PHARCO PHARMACEUTICALSECHO PHARMACY (U) LIMITEDAZOMYCINAZITHROMYCIN250MGPHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT.
P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT
EGYPTORAL SOLID ORDINARY CAPSULES1.0X1.0X6.0 CAPSULE BLISTER07/01/13
614NDA/MAL/HDP/0981HOVID BHDUNITED HEALTHCARE DISTRIBUTORS LTDCLOFENAC SR TABLETSDICLOFENAC SODIUM100MGHOVID BERHAD (CHEMOR SITE)--LOT 56442, 71/2, JALAN IPOH/CHEMOR 31200, PERAK. MALAYSIA MALAYSIAORAL SOLID RETARD FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2008
615NDA/MAL/HDP/0982ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDASMETO-10METOCLOPRAMIDE10MGASTRA LIFE CARE (INDIA) PVT-SURVEY NO.57/P, SARKHEJ-BAVLA HIGHWAY, POST- RAJOD-382220, TALUKA-BAVLA, DIST-AHMEDABAD. INDIAORAL SOLID ORDINARY OTHER COATED TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER01/07/2014
616NDA/MAL/HDP/0984CADILA PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.JOVAN T20TADALAFIL20MGCADILA PHARMACEUTICALS LIMITED-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER01/07/2013
617NDA/MAL/HDP/0986EVA PHARMAWIDE SPECTRUM ENTERPRISES (U) LIMITEDCONVENTINGABAPENTIN100MGEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT EGYPTORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER01/07/2013
618NDA/MAL/HDP/0987SQUARE PHARMACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDALATROL TABLETSCETIRIZINE10MGSQUARE PHARMACEUTICALS LIMITED-KALIAKOIR GAZIPUR – 1750, BANGLADESH BANGLADESHORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2013
619NDA/MAL/HDP/0988CADILA PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.CADITOR 20ATORVASTATIN20MGCADILA PHARMACEUTICALS LIMITED-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2013
620NDA/MAL/HDP/0990EVA PHARMAWIDE SPECTRUM ENTERPRISES (U) LIMITEDFUSIDERM CREAMFUSIDIC ACID2%W/WEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT EGYPTTOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE01/07/2013
621NDA/MAL/HDP/0995LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDFLUCOMOLPARACETAMOL + PHENYLEPHRINE HCL + DEXTROMETHORPHAN HBR + CHLORPHENIRAMINE MALEATE250MG + 5MG + 10MG + 2MGLINCOLN PHARMACEUTICALS LTD--TRIMUL ESTATE AFER VODSAR VILLAGE KHATJAT 382 721 GUJARAT VADSAR P.O.J TALUKA KALOH DIST GANDHINAGAR INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE07/01/14
622NDA/MAL/HDP/0997EVA PHARMAWIDE SPECTRUM ENTERPRISES (U) LIMITEDGENUPHILGLUCOSAMINE SULPHATE SODIUM CHLORIDE+METHYLSULPHONYLMETHANE+CHONDROITIN SULPHATE375MG+375MG+300MGEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT EGYPTORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2013
623NDA/MAL/HDP/0999EVA PHARMAWIDE SPECTRUM ENTERPRISES (U) LIMITEDTHIOEVATHIOTIC ACID600MGEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT EGYPTORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X10.0 TABLET BLISTER01/07/2014
624NDA/MAL/HDP/1000TROIKAA PHARMACEUTICALS LIMITEDABACUS PHARMA (AFRICA) LIMITEDTROYCURIUMATRACURIUM10MG/MLTROIKAA PHARMACEUTICALS LIMITED-THOL, DIST. MEHSANA-382728, GUJARAT,INDIA INDIAPARENTERAL ORDINARY AMPOULES1.0X5.0X3.0 ML AMPOULE,1.0X5.0X2.5 ML AMPOULE01/07/2012
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626NDA/MAL/HDP/1002SQUARE PHARMACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDCIPROCIN T 750CIPROFLOXACIN750MGSQUARE PHARMACEUTICALS LIMITED-KALIAKOIR GAZIPUR – 1750, BANGLADESH BANGLADESHORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X10.0 TABLET BLISTER01/07/2013
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647NDA/MAL/HDP/1028BIOCON LTDABACUS PHARMA (AFRICA) LIMITEDINSUGEN -30/70 (BIPHASIC)INSULIN HUMAN30/70I.U/MLBIOCON LIMITED-SPECIAL ECONOMIC ZONE PLOT 204 PHASE IV BOMMASANDRA JIGANI LINK ROADINDIAPARENTERAL ORDINARY S C VIALS1.0X10.0 ML VIAL,1.0X1.0X5.0X3.0 ML CARTRIDGE01/07/2012
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683NDA/MAL/HDP/1077NECTAR LIFESCIENCES LTDAIVEEN (U) LIMITEDNECTRAMCEFTRIAXONE1GNECTAR LIFESCIENCES LTD UNIT VI-BHATOLIKALAN P.O BAROTIWALA DISTT SOLAN HIMACHAL PRADESH 173205INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0X1.0 G VIAL + 1*10 ML WFI AMPOULE01/07/2013
684NDA/MAL/HDP/1078MICRO LABS LTDLABOREX UGANDA LIMITEDLEVOBACT INFUSIONLEVOFLOXACIN HEMIHYDRATE500MGAHLCON PARENTERALS (INDIA) LTD-SP-917-918, PHASE-III BHIWADI-301019, ALWAR, RAJASTHAN INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X100.0 ML BOTTLE01/07/2013
685NDA/MAL/HDP/1079AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOG-QUINE SYRUPQUININE HYDROCHLORIDE100MG/5MLAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE01/07/2000
686NDA/MAL/HDP/1080ALKEM LABORATORIES LIMITEDABACUS PHARMA (AFRICA) LIMITEDZOCEF 250 TABLETSCEFUROXIME AXETIL250MGALKEM LABORATORIES LIMITED.-VILLAGE THANA, BADDI, TEHSIL-NALAGARH, DISTT-SOLAN, (HP), INDIA-173205 INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X6.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER01/07/2009
687NDA/MAL/HDP/1081BRICVED LTDBOOTS PHARMACEUTICALS LIMITEDACIDEXSODIUM BICARBONATE + SODIUM ALGINATE + CALCIUM CARBONATE267MG + 500MG + 160MG /10MLPINEWOOD LABORATORIES LTD-BALLYMACARBRY, CLONMEL, TIPPERARY, IRELAND IRELANDORAL LIQUID ORDINARY SUSPENSIONS1.0X200.0 ML BOTTLE01/07/2013
688NDA/MAL/HDP/1082DAWA LIMITEDSUPER MEDIC LTDDACOF PAEDIATRICDIPHENHYDRAMINE HYDROCHLORIDE + SODIUM CITRATE + MENTHOL75MG + 28.5MG + 0.55MGDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE01/07/2013
689NDA/MAL/HDP/1083GALPHA LABORATORIES LTDAIVEEN (U) LIMITEDCHOCOFER SYRUPIRON + FOLIC ACID50MG + 0.5MG /5MLGALPHA LABORATORIES LIMITED-VILLAGE – THANA BADDI, TEHSIL BADDI
SOLAN HIMACHAL PRADESH-173 205 INDIA
INDIAORAL LIQUID ORDINARY SYRUPS1.0X200.0 ML BOTTLE01/07/2013
690NDA/MAL/HDP/1084DAWA LIMITEDSUPER MEDIC LTDDAWA-CPMCHLORPHENIRAMINE MALEATE4MGDAWA LTD-BABA DOGO ROAD RUARAKAKENYAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER07/01/13
691NDA/MAL/HDP/1085AGIO PHARMACEUTICALS LTDROYAL PHARMA 2011 LIMITEDDICLOGEN 1% GELDICLOFENAC GEL BP1%W/WAGIO PHARMACEUTICALS LTD .-A-82, MIDC, BHOSARI, PUNE-411026 INDIATOPICAL EXTERNAL OTHER GELS/SOLS1.0X20.0 G TUBE,1.0X30.0 G TUBE01/07/2013
692NDA/MAL/HDP/1086NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDSYNOGEN TABLETSDIACEREIN + METHYL SULPHONYL METHANE + GLUCOSAMINE SULPHATE50MG +250MG + 750MGNEM LABORATORIES LIMITED-133 KRISHNA IND. ESTATE, VASAI (E),
THANE – 401 210, MAHARASHTRA – INDIA
INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2012
693NDA/MAL/HDP/1087AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOCYCLINETETRACYCLINE3%W/WAGOG PHARMA LTD.-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIATOPICAL EXTERNAL OINTMENTS1.0X15.0 G TUBE01/07/2013
694NDA/MAL/HDP/1088GALPHA LABORATORIES LTDAIVEEN (U) LIMITEDRESTUMCEFUROXIME SODIUM750MGALKEM LABORATORIES LTD-VILLAGE – THANA, BADDI TEHSIL – NALAGARH, DIST-SOLAN (HP), INDIA – 173205 INDIAPARENTERAL ORDINARY DRY VIALS1.0X750.0 MG VIAL01/07/2015
695NDA/MAL/HDP/1094MICRO LABS LTDLABOREX UGANDA LIMITEDGRAMOCEF-O-100CEFIXIME100MG/5MLMICRO LABS LTD--NO. 121-124 4TH PHASE K.I.A.D.B BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK BANGALORE 560 099INDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE01/07/2013
696NDA/MAL/HDP/1095MICRO LABS LTDLABOREX UGANDA LIMITEDEROSTINE-20EBASTINE20MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER01/07/2012
697NDA/MAL/HDP/1099GLENMARK PHARMACEUTICAL LTD.STAR PHARMACEUTICALS LTDMOMATE F CREAMFUSIDIC ACID+MOMETASONE FUROATE2.1%W/W + 0.1W/WGLENMARK PHARMACEUTICALS LTD UNIT II.-UNIT II VILLAGE BHATTANWALA NALAGARH DIST SOLAN HIMACHAL PRADESHINDIATOPICAL EXTERNAL CREAMS1.0X10.0 G TUBE01/07/2012
698NDA/MAL/HDP/1100AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOVIR SKIN CREAMACICLOVIR5% W/WAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIATOPICAL EXTERNAL CREAMS1.0X10.0 G TUBE,1.0X5.0 G TUBE07/01/13
699NDA/MAL/HDP/1102MATRIX UGANDA LTDROYAL PHARMA 2011 LIMITEDOVUREXCLOMIPHENE50MG Y.S.P INDUSTRIES (M) SDN BDH - LOT 3,5 & 7 P/7 SECTION 13 KAWASAN PERINDUSTRIAN BANDAR BARU BANGI 43000 KAJANG SELANGOR DARUL EHSAN MALAYSIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER01/07/2011
700NDA/MAL/HDP/1103AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOCIN CREAMNEOMYCIN SULPHATE0.5% W/WAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE01/07/2014
701NDA/MAL/HDP/1104HOVID BHDUNITED HEALTHCARE DISTRIBUTORS LTDLIPIDUCE 10ATORVASTATIN10MGHOVID BHD -121 ,JALAN TUNKU ABDUL RAHMAN , 30010 IPOH , PERAK , MALAYSIA MALAYSIAORAL SOLID ORDINARY TABLETS1.0X10.0X3.0 TABLET BLISTER01/07/2014
702NDA/MAL/HDP/1105DAWA LIMITEDSUPER MEDIC LTDDERMAZINE PLUSSILVER SULPHADIAZINE AND CHLORHEXIDINE GLUCONATE1%W/W / 10.0%W/WDAWA LIMITED -BABA DOGO RWARAKAKENYATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE07/01/14
703NDA/MAL/HDP/1106EVA PHARMAWIDE SPECTRUM ENTERPRISES (U) LIMITEDDIACEREINDIACEREIN50MGEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT EGYPTORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER,1.0X2.0X10.0 CAPSULE BLISTER01/07/2013
704NDA/MAL/HDP/1107SERUM INSTITUTE OF INDIA LTD.NORVIK ENTERPRISES LIMITEDHEPATITIS B VACCINE(RDNA) (PAEDIATRIC))HEPATITIS B VACCINE(RDNA)10MCG /0.5MLSERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIA INDIAPARENTERAL ORDINARY I M VIALS1.0X25.0X5.0 ML VIAL (10 DOSES),1.0X10.0X0.5 ML VIAL (1 DOSE)01/07/2005
705NDA/MAL/HDP/1109DAWA LIMITEDSUPER MEDIC LTDDAWA-CPMCHLORPHENIRAMINE MALEATE2MG/5MLDAWA PHARMACEUTICALS LIMITED-PLOT 7879, BABA DOGO ROAD RUARAKA KENYAORAL LIQUID ORDINARY SYRUPS1.0X60.0 ML BOTTLE01/07/2014
706NDA/MAL/HDP/1111DAWA LIMITEDSUPER MEDIC LTDFAST-ACT GELDICLOFENAC DIETHYLAMINE + METHYL SALICYLATE + LINSEED OIL + MENTHOL CRYSTALS1.16%W/W + 10%W/W + 3%W/W + 5%W/WDAWA PHARMACEUTICALS LIMITED-PLOT 7879, BABA DOGO ROAD RUARAKA KENYATOPICAL EXTERNAL GELS AND SOLS1.0X20.0 G TUBE01/07/2013
707NDA/MAL/HDP/1112AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDZIDOVUDINE CAPSULESZIDOVUDINE100MGAUROBINDO PHARMA LTD .-UNIT III SURVEY NO.313 BACHUINDIAORAL SOLID ORDINARY CAPSULES1.0X100.0 CAPSULE CONTAINER01/07/2008
708NDA/MAL/HDP/1113MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDALCID-YELLOWMULTI-INGREDIENTMULTI-INGREDIENTTORQUE PHARMACEUTICALS PVT LTD-ISAAPUR P.O DAPPAR 140056 INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X400.0 ML BOTTLE,1.0X160.0 ML BOTTLE01/07/1997
709NDA/MAL/HDP/1114NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDTRANGEL ULTRADICLOFENAC/METHYL SALICYLATE/MENTHOL/CAPSICUM OLEORESIN10MG/80MG/60MG/0.15MGNEM LABORATORIES LIMITED-133 KRISHNA IND. ESTATE, VASAI (E),
THANE – 401 210, MAHARASHTRA – INDIA
INDIATOPICAL EXTERNAL GELS AND SOLS1.0X20.0 G CONTAINER01/07/2012
710NDA/MAL/HDP/1117NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDTETRACYCLINE EYE OINTMENT USP 1%TETRACYCLINE1%W/WNEM LABORATORIES LIMITED-133 KRISHNA IND. ESTATE, VASAI (E),
THANE – 401 210, MAHARASHTRA – INDIA
INDIAOPHTHALMIC OINTMENTS1.0X20.0X3.5 G TUBE01/07/2013
711NDA/MAL/HDP/1122PHARMACIE BETHELABACUS PARENTERAL DRUGS LIMITEDABCHLOR EAR DROPSCHLORAMPHENICOL5%W/VABACUS PARENTERAL DRUGS LIMITED-BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA. UGANDAOTIC DROPS1.0X10.0 ML VIAL,1.0X5.0 ML VIAL01/07/2013
712NDA/MAL/HDP/1123AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOPARPARACETAMOL500 MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CONTAINER01/07/2012
713NDA/MAL/HDP/1124AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGO SCRUBCHLORHEXIDINE GLUCONATE4%W/VAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIATOPICAL EXTERNAL LIQUIDS1.0X1.0X500.0 ML BOTTLE01/07/2013
714NDA/MAL/HDP/1125AUROBINDO PHARMA LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDAUROXONE 1000CEFTRIAXONE1000MGAPI AMMAN PHARMACEUTICAL INDUSTRIES-UNIT VI, SY. NO 329/39, 329/ INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0 G VIAL01/07/2009
715NDA/MAL/HDP/1128LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDBTC KITFLUCONAZOLE + AZITHROMYCIN + SECNIDAZOLE150MG + 1G + 1GLINCOLN PHARMACEUTICALS L.T.D-TRIMUL ESTATE KHATRAJ 382721 GHANDINAGAR GUJARATINDIAORAL SOLID ORDINARY COMBINATION PACK TABLETS1.0X4.0 TABLET BLISTER01/07/2013
716NDA/MAL/HDP/1130LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDKLARO-500CLARITHROMYCIN TABLETS500MGLINCOLN PHARMACEUTICALS LIMITED-10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X1.0X10.0 TABLET BLISTER01/07/2012
717NDA/MAL/HDP/1132STEDMAN PHARMACEUTICALS PVT. LTDVEERAM HEALTHCARE (U) LIMITEDM-CALZCALCIUM CITRATE +MAGNESIUM HYDROXIDE + ZINC SULPHATE + COLECALCIFEROL1000MG+100MG+4MG+200.I.USTEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET STRIP01/07/2012
718NDA/MAL/HDP/1133MEDIPHARM INDUSTRIES LTDMEDIPHARM INDUSTRIES (E.A) LTDMEDICOL SUSPENSIONCHLORAMPHENICOL125MG/5MLMEDIPHARM INDUSTRIES (E.A) LTD-PLOT 65, KAKAJJO ROAD, BWEYOGERERE UGANDAORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE01/07/2007
719NDA/MAL/HDP/1136AGOG PHARMA LTD.GITTOES PHARMACEUTICALS LIMITEDAGOSCAB APPLICATIONBENZYL BENZOATE25%W/WAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIATOPICAL EXTERNAL EMULSIONS1.0X1.0X100.0 ML BOTTLE01/07/2013
720NDA/MAL/HDP/1138AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGO-CALAMINECALAMINE15%W/WAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIATOPICAL EXTERNAL LOTIONS1.0X1.0X100.0 ML BOTTLE01/07/2013
721NDA/MAL/HDP/1139AGOG PHARMA LTD.GITTOES PHARMACEUTICALS LIMITEDAGOVATEBETAMETHASONE0.1%W/WAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE01/07/2013
722NDA/MAL/HDP/1140AGOG PHARMA LTD.GITTOES PHARMACEUTICALS LIMITEDAGOVATE-NBETAMETHASONE+NEOMYCIN SULPHATE0.1%W/W+0.5%W/WAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE01/07/2013
723NDA/MAL/HDP/1141LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDCALBONECALCIUM CARBONATE + COLECALCIFEROL250MG+125MG/5MLSAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIA INDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE01/07/2012
724NDA/MAL/HDP/1142AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDCANDIZOLCLOTRIMAZOLE1%W/WAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIATOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE01/07/2013
725NDA/MAL/HDP/1143LINCOLN P'CALS LTDMETRO PHARMACEUTICALS LIMITEDLOSA-HLOSARTAN + HYDROCHLOROTHIAZIDE50MG + 12.5MGLINCOLN PHARMACEUTICALS LIMITED-10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2012
726NDA/MAL/HDP/1145HILTON PHARMA (PVT) LTDHEALTHCARE LTD.HILACLACTULOSE68%W/VHILTON PHARMA (PVT) LTD-PLOT 13 SECTOR 15 KORANGI INDUSTRIAL AREA KARACHIPAKISTANORAL LIQUID ORDINARY SYRUPS1.0X120.0 ML BOTTLE01/07/2005
727NDA/MAL/HDP/1147CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDVALAZYDVALSARTAN80MGCADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER07/01/11
728NDA/MAL/HDP/1148CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDODIMONT 10MONTELUKAST10MGCADILA HEALTH CARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA INDIAORAL SOLID ORDINARY COATED TABLETS1.0X10.0X10.0 TABLET BLISTER07/01/12
729NDA/MAL/HDP/1149UNIVERSAL CORPORATION LTDDELMAW ENTERPRISES LIMITEDNEUROBAGABAPENTIN300MGUNIVERSAL CORPORATION LTD..-PLOT 13777 CLUB ROAD, PAST KIKUYU KENYAORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER01/07/2015
730NDA/MAL/HDP/1154SUN PHARMACEUTICAL INDUSTRIES LIMITEDSTAR PHARMACEUTICALS LTDBACQUREIMIPENEM + CILASTATIN500MG + 500MGSUN PHARMACEUTICAL INDUSTRIES LIMITED-INDUSTRIAL AREA NO.3, A.B. ROAD DEWAS, 455001 (MP), INDIA.

INDIAPARENTERAL ORDINARY DRY VIALS1.0X30.0 ML VIAL01/07/2012
731NDA/MAL/HDP/1156CIPLA LTDQUALITY CHEMICALS LTD - HUMANFUNGICIPCLOTRIMAZOLE1%W/WCIPLA LTD ----L139 TO L-146 VERNA INDUSTRIAL ESTATE VERNA SALCETTE GOA 403 722INDIATOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE01/07/2011
732NDA/MAL/HDP/1157Y.S.P INDUSTRIES (M) SDN BHDROYAL PHARMA 2011 LIMITEDTRETINONTRETINOIN0.05%W/WY.S.P.INDUSTRIES(M)SBD,BHD-LOT 3,5,& 7,JALANP/7,SECTION13,KAWASAN PERINDUSTRIAN BANDAR BARUBANGI,43000 KAJANG SELANGOR DARUL EHSAN, MALAYSIA MALAYSIATOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE01/07/2013
733NDA/MAL/HDP/1158TRIVENI FORMULATIONS LIMITEDAIVEEN (U) LIMITEDTRAMADOLTRAMADOL50MGTRIVENI FORMULATIONS LTD .-PLOT NO. 52, 53,54 ALEAP INDUSTRIAL ESTATE SURAMPALLI VILLAGE GANNAVARAM MANDAL KRISHNA (DT) A.P INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER01/07/2012
734NDA/MAL/HDP/1159Y.S.P INDUSTRIES (M) SDN BHDROYAL PHARMA 2011 LIMITEDVORENDICLOFENAC SODIUM50MGY.S.P.INDUSTRIES(M)SBD,BHD-LOT 3,5,& 7,JALANP/7,SECTION13,KAWASAN PERINDUSTRIAN BANDAR BARUBANGI,43000 KAJANG SELANGOR DARUL EHSAN, MALAYSIA MALAYSIARECTAL SYSTEMIC SUPPOSITORIES1.0X2.0X5.0 SUPPOSITORY STRIP,1.0X10.0X10.0 SUPPOSITORY STRIP01/07/2013
735NDA/MAL/HDP/1160DAFRA PHARMA LTDLABOREX UGANDA LIMITEDDAFRACLAVAMOXYCILLIN + CLAVULANIC ACID875MG+125MGBILIM PHARMACEUTICALS--CERKEZKOY PLANT, 59500 CERKEZKOY, TEKIRDAG TURKEYORAL SOLID ORDINARY TABLETS1.0X2.0X5.0 TABLET BLISTER01/07/2011
736NDA/MAL/HDP/1163NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDFRUSEMIDEFUROSEMIDE40MGNEM LABORATORIES LIMITED-133 KRISHNA IND. ESTATE, VASAI (E),
THANE – 401 210, MAHARASHTRA – INDIA
INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER01/07/2013
737NDA/MAL/HDP/1164TRIVENI FORMULATIONS LIMITEDAIVEEN (U) LIMITEDPIROXICAMPIROXICAM20MGTRIVENI FORMULATIONS LTD .-PLOT NO. 52, 53,54 ALEAP INDUSTRIAL ESTATE SURAMPALLI VILLAGE GANNAVARAM MANDAL KRISHNA (DT) A.P INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER01/07/2013
738NDA/MAL/HDP/1166PANACEA BIOTEC LTDABACUS PHARMA (AFRICA) LIMITEDDOLZEROTRAMADOL HYDROCHLORIDE + PARACETAMOL37.5MG + 325MGPANACEA BIOTEC LTD-MALPUR, BADDI, TEHSIL, NALAGARH, DIST. SOLAN (H.P) – 173 205 INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2013
739NDA/MAL/HDP/1167CIRON DRUGS AND PHARMACEUTICALS PVT LTDRENE PHARMACY LTDMETOCLOPRAMIDE INJECTIONMETOCLOPRAMIDE5MG/MLCIRON DRUGS & PHARMACEUTICALS PVT LTD .-N-118,M.I.D.C, TARAPUR,BOISAR, DIST.THANE-401506, MAHARASHTRA,INDIA. INDIAPARENTERAL ORDINARY AMPOULES1.0X10.0X10.0X2.0 ML AMPOULE01/07/2010
740NDA/MAL/HDP/1168DAWA LIMITEDSUPER MEDIC LTDDAWA-CORT CREAMHYDROCORTISONE1%W/WDAWA LTD -BABA DOGO ROAD, RUARAKA P.O.BOX 16633-00620, NAIROBI KENYA KENYATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE01/07/2009
741NDA/MAL/HDP/1169ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDNEBI 5NEBIVOLOL HYDROCHLORIDE5MGARISTO PHARMACEUTCALS PVT LTD-PLOT NO.208 NEW INDUSTRIAL AREA NO.II MANDIDEEP 462046 RAISEN MADHYA PRADESHINDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER01/07/2013
742NDA/MAL/HDP/1170ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDARISTO MEGANEURONMETHYLCOBALAMIN500MCGARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO.II,MANDIDEEEP PRADESH INDIAPARENTERAL ORDINARY I M AMPOULES1.0X1.0ML AMPOULE01/07/2013
743NDA/MAL/HDP/1172CIRON DRUGS AND PHARMACEUTICALS PVT LTDRENE PHARMACY LTDLIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDE 20MG/MLCIRON DRUGS & PHARMACEUTICALS PVT LTD .-N-118,M.I.D.C, TARAPUR,BOISAR, DIST.THANE-401506, MAHARASHTRA,INDIA. INDIAPARENTERAL ORDINARY VIALS1.0X20.0 ML VIAL,1.0X30.0 ML VIAL01/07/2010
744NDA/MAL/HDP/1176AMOUN PHARMACEUTICALS COMPANYBOOTS PHARMACEUTICALS LIMITEDFUNGISAFETERBINAFINE HYDROCHLORIDE1%W/WAMOUN PHARMACEUTICAL CO. S.A.E-1ST INDUSTRIAL ZONE A, PLOTS NO. 1B,2,3,4,5 BLOCK 13015, EL-OBOUR CITY,
KALYOUBIA CAIRO EGYPT
EGYPTTOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE01/07/2013
745NDA/MAL/HDP/1178HETERO DRUGS LTDAIVEEN (U) LIMITEDTENOFOVIRTENOFOVIR DISOPROXIL FUMARATE300MGHETERO LABS LTD-22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESHINDIAORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET CONTAINER07/01/13
746NDA/MAL/HDP/1179MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDOVITRELLECHORIOGONADOTROPIN ALFA250MCG/0.5MLMERCK SERONO SA-1170 AUBONNE(SWITZERLAND) MERCK SERONO S.P.A-VIA DELLE MAGNOLIE,15.70026 MODUGNO (BA).ITALY SWITZERLANDPARENTERAL ORDINARY PRE-FILLED SYRINGES1.0X1.0 PREFILLED SYRINGE CARTON01/07/2015
747NDA/MAL/HDP/1180SQUARE PHARMACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDZIF TIMED RELEASED CAPSULESDRIED FERROUS SULPHATE+ZINC SULPHATE MONOHYDRATE+FOLIC ACID150MG+61.8MG+0.5MGSQUARE PHARMACEUTICALS LIMITED--DHAKA UNIT KALIAKOIR GAZIPUR – 1750, BANGLADESH BANGLADESHORAL SOLID RETARD CAPSULES1.0X10.0X10.0 CAPSULE BLISTER01/07/2013
748NDA/MAL/HDP/1181TORRENT PHARAMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.ASTHATOR 4MONTELUKAST SODIUM4 MGTORRENT PHARMACEUTICALS LIMITED-VILLAGE .BHUD-MAKHNU MAJRA, TEHSIL: BADDI 173205 DIST SOLAN (H.P), INDIA. INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2013
749NDA/MAL/HDP/1182TORRENT PHARAMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.ASTHATOR 5MONTELUKAST SODIUM5MGTORRENT PHARMACEUTICALS LIMITED-VILLAGE .BHUD-MAKHNU MAJRA, TEHSIL: BADDI 173205 DIST SOLAN (H.P), INDIA. INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2013
750NDA/MAL/HDP/1184DAWA LIMITEDSUPER MEDIC LTDDACOF MUCOLYTICSALBUTAMOL + BROMHEXINE + GUAIPHENESIN + MENTHOL2.0MG + 4.0MG +100MG + 1.0MGDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE01/07/2013
751NDA/MAL/HDP/1185DAWA LIMITEDSUPER MEDIC LTDDACOF DRYDIPHENHYDRAMINE + DEXTROMETHORPHAN + MENTHOL12.5MG + 6.5MG + 1.10MGDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE01/07/2013
752NDA/MAL/HDP/1186DAWA LIMITEDSUPER MEDIC LTDDACOF EXPECTORANTDIPHENHYDRAMINE HYDROCHLORIDE + AMMONIUM CHLORIDE + SODIUM CITRATE + MENTHOL14.0MG + 135.0MG + 57.0MG + 1.10MGDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE01/07/2013
753NDA/MAL/HDP/1187GALPHA LABORATORIES LTDAIVEEN (U) LIMITEDKEFTAZ-1000CEFTAZIDIME1 GALKEM LABORATORIES LTD-VILLAGE – THANA, BADDI TEHSIL – NALAGARH, DIST-SOLAN (HP), INDIA – 173205 INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0X1.0 G VIAL + 1*10 ML WATER FOR INJECTION01/07/2013
754NDA/MAL/HDP/1194VENUS REMEDIES LTDHARLEYS UGANDA LIMITEDPISAPIPERACILLIN + TAZOBACTAM4000MG/VIAL + 500MG/VIALVENUS REMEDIES LTD, UNIT II,-HILL TOP INDUSTRIAL ESTATE, JHARMAJTI, EPIP, PHASE-1 (EXTENSION), BHATOLI KALAN, BADDI -HP INDIAPARENTERAL ORDINARY VIALS1.0X1.0X30.0 ML VIAL01/07/2009
755NDA/MAL/HDP/1195UNIVERSAL CORPORATION LTDHARLEYS UGANDA LIMITEDALTRINECETIRIZINE5MG/5MLUNIVERSAL CORPORATION LIMITED -PLOT 13777 KIKUYU ROAD, KIKUYU TOWN, PAST POST OFFICE KENYAORAL LIQUID ORDINARY SYRUPS1.0X60.0 ML BOTTLE,1.0X30.0 ML BOTTLE01/07/2013
756NDA/MAL/HDP/1196UNIVERSAL CORPORATION LTDDELMAW ENTERPRISES LIMITEDACNESOLTRETINOIN0.05%W/WUNIVERSAL CORPORATION LTD..-PLOT 13777 CLUB ROAD, PAST KIKUYU KENYATOPICAL EXTERNAL CREAMS1.0X25.0 G TUBE01/07/2012
757NDA/MAL/HDP/1202MEDIPHARM INDUSTRIES LTDMEDIPHARM INDUSTRIES (E.A) LTDQUINIMIX SYRUPQUININE HYDROCHLORIDE100MG/5MLMEDIPHARM INDUSTRIES (E.A) LTD-PLOT 65, KAKAJJO ROAD, BWEYOGERERE UGANDAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE01/07/2003
758NDA/MAL/HDP/1205MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDEFAVIRENZEFAVIRENZ600MGMYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE
MYLAN LABORATORIES LTD -- PLOT NO. H-12 & H-13 MIDCWALUJ INDUSTRIAL AREA AURANGABAD 431136 MAHARASTRA
INDIAORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET CONTAINER07/01/08
759NDA/MAL/HDP/1206THE METHOLATUM CO. LTDHARLEYS UGANDA LIMITEDDEEP RELIEFIBUPROFEN + MENTHOL5%W/W + 3% W/WTHE MENTHOLATUM CO. LTD. -1 REDWOOD AVE PEEL PARK CAMPUS EAST KILBRIDEUNITED KINGDOMTOPICAL EXTERNAL OTHER GELS/SOLS1.0X50.0 G CONTAINER,1.0X15.0 G CONTAINER,1.0X30.0 G CONTAINER01/07/2013
760NDA/MAL/HDP/1208ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDVISCO LIQUIDALGINIC ACID + MAGNESIUM HYDROXIDE + ALUMINIUM HYDROXIDE + SIMETHICONE100 MG + 250 MG + 125 MG + 50 MGARISTO PHARMACEUTCALS PVT LTD-PLOT NO.208 NEW INDUSTRIAL AREA NO.II MANDIDEEP 462046 RAISEN MADHYA PRADESHINDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X1.0X200.0 ML BOTTLE01/07/2011
761NDA/MAL/HDP/1209MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDARBITEL-80TELMISARTAN80MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER07/01/11
762NDA/MAL/HDP/1211ASTRA ZENECAMACNAUGHTON LIMITEDBRILINTATICAGRELOR90MGASTRA ZENECA AB-SE-151 85 SODERTALJE, SWEDEN (GARTUNAVAGEN & SNACKVIKEN) UNITED KINGDOMORAL SOLID ORDINARY TABLETS1.0X4.0X14.0 TABLET BLISTER01/07/2011
763NDA/MAL/HDP/1212GUILIN PHARMACEUTICALS CO.LTDSTAR PHARMACEUTICALS LTDGLINTHERARTEMETHER80MG/MLGUILIN PHARMACEUTICAL CO.,LTD-NO 43 QILIDIAN ROAD GUILIN 541002, GUANGXI CHINAPARENTERAL ORDINARY I M AMPOULES1.0X6.0X1.0 ML AMPOULE01/07/2011
764NDA/MAL/HDP/1214FERRER INTERNACIONAL S.ALABOREX UGANDA LIMITEDNUCLEO C.M.P FORTECYTIDINE+URIDINE5MG+3MGFERRER INTERNACIONAL, S.A-JOAN BUCSALA 1-9, 08173 SANT CUGAT DEL VALLES, BARCELONA, SPAIN SPAINORAL SOLID ORDINARY CAPSULES1.0X2.0X15.0 CAPSULE BLISTER07/01/13
765NDA/MAL/HDP/1215BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDGYNANFORT VAGINAL PESSARYMETRONIDAZOLE+NEOMYCIN SULPHATE+NYSTATIN500MG+65,000I.U+100,000I.UBLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIAINDIAVAGINAL SUPPOSITORIES1.0X10.0 TABLET BLISTER01/07/2013
766NDA/MAL/HDP/1217SANOFI AVENTISLABOREX UGANDA LIMITEDINSUMAN BASALRECOMBINANT HUMAN INSULIN100 IU/MLSANOFI-AVENTIS DEUTSCHLAND GMBH -INDUSTRIEPARK HOECHST, BRUNINGSTRASSEN, BUILDING
H650 65926 FRANKFURT AM MAIN, GERMANY
GERMANYPARENTERAL ORDINARY VIALS1.0X5.0X3.0 ML CARTRIDGE,1.0X5.0 ML VIAL01/07/2014
767NDA/MAL/HDP/1218BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDGSUNATE-50ARTESUNATE50MGBLISS INDASI LIFESCINCES PRIVATE LIMITED - -PLOT 73-76 SILVER INDUSTRIAL ESTATE,
BHIMPORE, DAMAN 396 210, INDIA
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768NDA/MAL/HDP/1219DENK PHARMA GMB H &CO. KGBENLE CONSULT LIMITEDTORAS-DENK 5TORASEMIDE5MGDENK PHARMA GMBH &CO.KG--PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANY GERMANYORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2014
769NDA/MAL/HDP/1220BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDLONARTARTEMETHER + LUMEFANTRINE180 MG + 1080 MGBLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X60.0 ML BLISTER01/07/2008
770NDA/MAL/HDP/1222MIRACALUS PHARMA PVT.LTDAIVEEN (U) LIMITEDBUPIVACAINE HYDROCHLORIDE IN DEXTROSE USPBUPIVACAINE HYDROCHLORIDE20MG/4MLNAPROD LIFE SCIENCES (PVT) LIMITED-PLOT G-17/1 MIDC TARAPUR BOISAR, DIST. THANE-401506 MAHARASTRA, INDIA INDIAPARENTERAL ORDINARY AMPOULES1.0X5.0X4.0 ML AMPOULE01/07/2012
771NDA/MAL/HDP/1223REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDWHITFIELD'S OINTMENTBENZOIC ACID + SALICYLIC ACID6%W/W + 3%W/WREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA KENYATOPICAL EXTERNAL OINTMENTS1.0X1.0X25.0 G TUBE01/07/1997
772NDA/MAL/HDP/1224KOTRAPHARMA (M) SDN.BHDABACUS PHARMA (AFRICA) LIMITEDVAXCEL CEFTRIAXONECEFTRIAXONE1GKOTRA PHARMA SDN BDN-1, 2, &3, JALANTTC12 CHENG INDUSTRIAL ESTATE, 75250, MELAKA, MALAYSIA MALAYSIAPARENTERAL ORDINARY DRY VIALS1.0X1.0 G VIAL01/07/2013
773NDA/MAL/HDP/1225AMOUN PHARMACEUTICAL COMPANYBOOTS PHARMACEUTICALS LIMITEDMOSEDIN PLUS SRPSEUDOEPHEDRINE HYDROCHLORIDE + LORATADINE120MG + 5MGAMOUN PHARMACEUTICAL CO. S.A.E-1ST INDUSTRIAL ZONE A, PLOTS NO. 1B,2,3,4,5 BLOCK 13015, EL-OBOUR CITY,
KALYOUBIA CAIRO EGYPT
EGYPTORAL SOLID ORDINARY CAPSULES1.0X1.0X10.0 CAPSULE BLISTER01/07/2013
774NDA/MAL/HDP/1226AFRICURE PHARMACEUTICALS (INDIA) LTDROYAL PHARMA 2011 LIMITEDSALBUTAMOLSALBUTAMOL4MGAFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED (755793)-PLOT 9-12,DEWAN & SONS INDUSTRIAL. AREA, VEOOR,PALGHAR-401404. INDIA. INDIAORAL SOLID ORDINARY TABLETS1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER07/01/05
775NDA/MAL/HDP/1227AMOUN PHARMACEUTICALS COMPANYBOOTS PHARMACEUTICALS LIMITEDFUNGISAFETERBINAFINE HCL250MGAMOUN PHARMACEUTICAL CO. S.A.E-1ST INDUSTRIAL ZONE A, PLOTS NO. 1B,2,3,4,5 BLOCK 13015, EL-OBOUR CITY,
KALYOUBIA CAIRO EGYPT
EGYPTORAL SOLID ORDINARY FILM-COATED TABLETS1.0X7.0 TABLET STRIP01/07/2013
776NDA/MAL/HDP/1228ASTRA LIFECARE (INDIA) PVT. LTDASTRA PHARMA (U) LIMITEDLUMETHERARTEMETHER + LUMEFANTRINE20 MG + 120 MGASTRA LIFECARE (INDIA) PVT. LTD-PLOT 57/P, SARKHEJ-BAVLA HIGHWAY, RAJODA 382 220, AHMEDABAD, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X4.0X6.0 TABLET BLISTER07/01/10
777NDA/MAL/HDP/1230MEDOPHARM PRIVATE LIMITEDPLANET PHARMACEUTICALS UGANDA LTDLOXAMPAMPICILLIN + CLOXACILLIN250 MG + 250 MGMEDOPHARM PVT LTD.-NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADUINDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER07/01/13
778NDA/MAL/HDP/1231NORVIK ENTERPRISES LIMITEDPLANET PHARMACEUTICALS UGANDA LTDMEDOMOX 125AMOXYCILLIN125MG/5MLMEDOPHARM PVT LTD.-NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADUINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE07/01/12
779NDA/MAL/HDP/1234MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDBISACODYL TABLETS BPBISACODYL5MGMACLEODS PHARMACEUTICALS LTD.-PLOT NO. 25-27 SURVEY NO. 366,
PREMIER INDUSTRIAL ESTATE, KACHIGAM,
DAMAN (UT) - 396210, INDIA.
INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X10.0X10.0 TABLET STRIP01/07/2007
780NDA/MAL/HDP/1238BETA HEALTHCARE UGANDA LIMITEDBETA HEALTHCARE UGANDA LIMITEDSEPTRIN INJECTIONCO-TRIMOXAZOLE480MG/5MLDRAXIS PHARMA INC.- QUEBEC, CANADA CANADAPARENTERAL ORDINARY AMPOULES1.0X10.0X5.0 ML AMPOULE01/07/1997
781NDA/MAL/HDP/1239IPCA LABORATORIES LTDMEDVIN PHARMA LIMITEDPECTYLIN-CDIPHENHYDRAMINE HYDROCHLORIDE+AMMONIUM HYDROCHLORIDE+SODIUM CITRATE+MENTHOL14MG+135MG+57MG+1.1MG IPCA LABORATORIES LTD,PLOT NO. T-139 -SEJAVTA, RATLAM-457 002 (M.P.) INDIA INDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE01/07/1997
782NDA/MAL/HDP/1242AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDTOPHEN-100PHENYTOIN100MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER01/07/2013
783NDA/MAL/HDP/1243DENK PHARMA GMBH & CO KGBENLE CONSULT LIMITEDLEVO DENK 250LEVOFLOXACIN HEMIHYDRATE250MGROTTENDORF PHARMA GMBH-OSTENFELDER STRASSE 51-61 59320 ENNIGERLOH GERMANYGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER01/07/2014
784NDA/MAL/HDP/1247AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDPROCIPCYPROHEPTADINE4MGAGOG PHARMA LTD.-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIAORAL SOLID ORDINARY TABLETS1.0X2.0X5.0X10.0 TABLET BLISTER01/07/2012
785NDA/MAL/HDP/1250STRIDES SHASUN LIMITEDDELMAW ENTERPRISES LIMITEDSTRIMOL EXTRAPARACETAMOL+CAFFEINE500MG+30MGSTRIDES ARCOLAB LTD-36/7 SURAGAJAKKANAHALI INDLAWADICROSS ANEKAL TALUK BANYALURE-562106INDIAORAL SOLID ORDINARY TABLETS1.0X5.0X4.0 TABLET BLISTER01/07/2014
786NDA/MAL/HDP/1252MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDZOYSILDENAFIL50MGTORQUE PHAMACEAUTICALS PVT LTD-VILL ISSAPUR P.O DAPPAR INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X1.0X4.0 TABLET BLISTER01/07/2013
787NDA/MAL/HDP/1254COSMOS LTDASTRA PHARMA (U) LIMITEDCOSATRIM TABLETSCO-TRIMOXAZOLE480MGCOSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA KENYAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER01/07/1998
788NDA/MAL/HDP/1255CIPLA LTDQUALITY CHEMICALS LTD - HUMANNIFELAT RETARDNIFEDIPINE20MGCIPLA LTD-MIDC PATALGANGA 410 220 DIST. RAIGADINDIAORAL SOLID RETARD TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/1997
789NDA/MAL/HDP/1256SIRMAXO CHEMICALS PVT LTDSUPER MEDIC LTDSANIQUAD PVP TPOVIDONE IODINE10%W/WSIRMAXO CHEMICALS PVT LTD-PLOT NO. E-35. TARAPRU MIDC BOISAR, THANE, MUMBAI, INDIA INDIATOPICAL EXTERNAL LIQUIDS1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X1000.0 ML BOTTLE01/07/2015
790NDA/MAL/HDP/1259IPCA LABORATORIES LTDMEDVIN PHARMA LIMITEDCARDOZ- 6.25CARVEDILOL6.25MG IPCA LABORATORIES LTD-PLOT NO. 255/1,
VILLAGE ATHAL,
SILVASSA-396230,
DADRA AND NAGAR HAVELI, INDIA.
INDIAORAL SOLID ORDINARY TABLETS1.0X2.0X14.0 TABLET BLISTER01/07/2013
791NDA/MAL/HDP/1260BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDDIABETAGLIBENCLAMIDE5MGBLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2013
792NDA/MAL/HDP/1261IPCA LABORATORIES LTDMEDVIN PHARMA LIMITEDCARDOZ-12.5CARVEDILOL12.5MG IPCA LABORATORIES LTD-PLOT NO. 255/1,
VILLAGE ATHAL,
SILVASSA-396230,
DADRA AND NAGAR HAVELI, INDIA.
INDIAORAL SOLID ORDINARY TABLETS1.0X2.0X14.0 TABLET BLISTER01/07/2013
793NDA/MAL/HDP/1264CENTAUR PHARMACEUTICALS PRIVATE LIMITEDGITTOES PHARMACEUTICALS LIMITEDOCUCYCLINE EYE OINTMENTTETRACYCLINE HYDROCHLORIDE1%W/WCENTAUR PHARMACEUTICALS PVT LTD --PLANT II PLOT 39-41 TIVIM INDUSTRIAL ESTATE KARASWADA MAPUSA GOA 403 526INDIAOPHTHALMIC OINTMENTS1.0X5.0 G TUBE,1.0X3.5 G TUBE01/07/2000
794NDA/MAL/HDP/1265AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDCOMBIPLEXVITAMIN B1 + VITAMIN B2 + NICOTINAMIDE + VITAMIN B61.0 MG + 1.0 MG + 15 MG + 0.5 MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY COATED TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER01/07/2008
795NDA/MAL/HDP/1270I CARE PHARMA LIMITEDVITACARE LTDPARAPARACETAMOL500MGHEBEI (ZHANGJIAKOU) KAIWEI PHARMACEUTICAL CO-27 LINGYUAN STREET, ZHANGJIAKOU, QIAO DONG DISTRICT HEBEI PROVINCE - PEOPLES’ REPUBLIC OF CHINA INDIAORAL SOLID ORDINARY TABLETS1.0X100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER01/07/2013
796NDA/MAL/HDP/1271INCEPTA PHARMACUTICALS LIMITEDECHO PHARMACY (U) LIMITEDONASERONONDANSETRON4MG/5MLINCEPTA PHARMACEUTICALS LIMITED- DEWAN IDRIS ROAD, BARA RANGAMATIA, ZIRABO
SAVAR, DHAKA, BANGLADESH
BANGLADESHORAL LIQUID ORDINARY LIQUIDS1.0X1.0X50.0 ML BOTTLE01/07/2012
797NDA/MAL/HDP/1274SURGE LAB (PVT) LIMITEDJEET PHARMACEUTICALS LIMITEDROMYCINAZITHROMYCIN250MGNABIQASIM INDUSTRIES (PVT) LTD--17/24,KORANGI INDUSTRIAL AREA, KORANGI, KARACHI- PAKISTAN. PAKISTANORAL SOLID ORDINARY CAPSULES1.0X1.0X6.0 CAPSULE BLISTER01/07/2007
798NDA/MAL/HDP/1275REMEDICA LTDGOODMAN INTERNATIONAL LTDNIFELAT 10 F.C TABLETSNIFEDIPINE10MGREMEDICA LIMITED -AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUS CYPRUSORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/1997
799NDA/MAL/HDP/1276INCEPTA PHARMACUTICALS LIMITEDECHO PHARMACY (U) LIMITEDPANTONIX 40 INJECTIONPANTOPRAZOLE SODIUM SEQUIHYDRATE40MGINCEPTA PHARMACEUTICALS LIMITED- DEWAN IDRIS ROAD, BARA RANGAMATIA, ZIRABO
SAVAR, DHAKA, BANGLADESH
BANGLADESHPARENTERAL ORDINARY AMPOULES1.0X1.0X40.0 MG VIAL 1*10ML AMPOULE OF 0.9% NACL01/07/2013
800NDA/MAL/HDP/1277SANOTI AVENTISLABOREX UGANDA LIMITEDINSUMAN RAPIDINSULIN HUMAN100 IU/MLSANOFI-AVENTIS DEUTSCHLAND GMBH-INDUSTRIEPARK HOECHST, BRUNINGSTRASSEN, BUILDING D-65926 FRANKFURT AM MAIN, GERMANY GERMANYPARENTERAL ORDINARY S C VIALS1.0X5.0 ML VIAL01/07/2015
801NDA/MAL/HDP/1278GUILIN PHARMACEUTICALS CO.LTDSTAR PHARMACEUTICALS LTDD-ARTEPPDIHYDROARTEMESININ + PIPERAQUINE PHOSPHATE40MG +320MGGUILIN PHARMACEUTICAL CO LTD-NO.43 QILIDIAN ROAD GUILIN 541004 GUANGXICHINAORAL SOLID ORDINARY TABLETS1.0X9.0 TABLET BLISTER,1.0X8.0 TABLET BLISTER01/07/2013
802NDA/MAL/HDP/1279INCEPTA PHARMACUTICALS LIMITEDECHO PHARMACY (U) LIMITEDOSTEO-D INJECTIONCHOLECALCIFEROL200000IU/MLINCEPTA PHARMACEUTICALS LIMITED- DEWAN IDRIS ROAD, BARA RANGAMATIA, ZIRABO
SAVAR, DHAKA, BANGLADESH
BANGLADESHPARENTERAL ORDINARY AMPOULES1.0X1.0X1.0 ML AMPOULE01/07/2012
803NDA/MAL/HDP/1281INCEPTA PHARMACUTICALS LIMITEDECHO PHARMACY (U) LIMITEDTOPICACINCAPSAICIN0.025%W/WINCEPTA PHARMACEUTICALS LIMITED- DEWAN IDRIS ROAD, BARA RANGAMATIA, ZIRABO
SAVAR, DHAKA, BANGLADESH
BANGLADESHTOPICAL EXTERNAL CREAMS1.0X1.0X20.0 G TUBE01/07/2012
804NDA/MAL/HDP/1282ZEE PHARMACEUTICALS LTDZEE PHARMACEUTICALS LIMITEDLOSABERGLOSARTAN POTASSIUM50MGTHE MADRAS PHARMACEUTICALS..-NO. 137B, OLD MAHABALIPURAM ROAD, KARAPAKKAM, CHENNAI 600096 INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2016
805NDA/MAL/HDP/1283INCEPTA PHARMACUTICALS LIMITEDECHO PHARMACY (U) LIMITEDTIMOZIN INJECTIONTIEMONIUM METHYLSULPHATE5MG/2MLINCEPTA PHARMACEUTICALS LIMITED- DEWAN IDRIS ROAD, BARA RANGAMATIA, ZIRABO
SAVAR, DHAKA, BANGLADESH
BANGLADESHPARENTERAL ORDINARY AMPOULES1.0X5.0X2.0 ML AMPOULE01/07/2012
806NDA/MAL/HDP/1285SANCE LABORATORIES PVT LTDDELMAW ENTERPRISES LIMITEDSANFUR-750CEFUROXIME750MGSANCE LABORATORIES PRIVATE LTD-PB NO. 2 ELAPPUNKAL JN, KOOZLUVANAL , 686 523, PALA, KOTTAYAM DISTRICT, KERALA, INDIA. INDIAPARENTERAL ORDINARY DRY VIALS1.0X750.0 MG VIAL01/07/2012
807NDA/MAL/HDP/1287SANCE LABORATORIES PVT LTDDELMAW ENTERPRISES LIMITEDSANIX- DS 100CEFIXIME100MG/5MLSANCE LABORATORIES PRIVATE LTD-PB NO. 2 ELAPPUNKAL JN, KOOZLUVANAL , 686 523, PALA, KOTTAYAM DISTRICT, KERALA, INDIA. INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE01/07/2014
808NDA/MAL/HDP/1290SANCE LABORATORIES PVT LTDDELMAW ENTERPRISES LIMITEDSANIX 400 CAPCEFIXIME400MGSANCE LABORATORIES PRIVATE LTD-PB NO. 2 ELAPPUNKAL JN, KOOZLUVANAL , 686 523, PALA, KOTTAYAM DISTRICT, KERALA, INDIA. INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER01/07/2013
809NDA/MAL/HDP/1291BAYER SCHERING PHARMASURGIPHARM (U) LIMITEDULTRAVIST-300IOPROMIDE300MG/MLBAYER PHARMA A.G-MULLERSTRASSE 178, 13353 BERLIN, GERMANY GERMANYPARENTERAL ORDINARY VIALS1.0X50.0 ML VIAL,1.0X100.0 ML VIAL01/07/2012
810NDA/MAL/HDP/1292AUROBINDO PHARMA LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDBE-STEDY 16BETAHISTINE DIHYDROCHLORIDE TABLETS16MGAUROBINDOPHARMA LIMITED,-SURVEY NO. 313 & 314, BACHUPALLY VILLAGE,
QUTHUBULLAPUR MANDAL, HYDERABAD,
RANGA REDDY (DT),
ANDHRA PRADESH - 500090
INDIA.
INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2013
811NDA/MAL/HDP/1293ZEE PHARMACEUTICALS LTDZEE PHARMACEUTICALS LIMITEDZEEGRA - 100SILDENAFIL CITRATE100MGTHE MADRAS PHARMACEUTICALS..-NO. 137B, OLD MAHABALIPURAM ROAD, KARAPAKKAM, CHENNAI 600096 INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X4.0 TABLET BLISTER01/07/2016
812NDA/MAL/HDP/1294BAYER SCHERING PHARMASURGIPHARM (U) LIMITEDULTRAVIST 370IOPROMIDE370MG/MLBAYER PHARMA A.G-MULLERSTRASSE 178, 13353 BERLIN, GERMANY GERMANYPARENTERAL ORDINARY VIALS1.0X100.0 ML VIAL,1.0X50.0 ML VIAL01/07/2012
813NDA/MAL/HDP/1295SHAIGAN PHARMACEUTICALS (PVT) LTDHEALTHCARE LTD.ZEPARALBENDAZOLE200MGSHAIGAN PHARMACEUTICALS (PVT) LTD-14TH KM, ADYALA ROAD, RAWALPINDI-PAKISTAN PAKISTANORAL SOLID ORDINARY TABLETS1.0X2.0 TABLET BLISTER01/07/1997
814NDA/MAL/HDP/1297CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDOLMY 40OLMESARTAN40MGCADILA HEALTH CARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2012
815NDA/MAL/HDP/1298HOVID BHDUNITED HEALTHCARE DISTRIBUTORS LTDNEUROVIT FORTETHIAMINE MONONITRATE/ PYRIDOXINE/ CYANOCOBALAMIN245.5MG/ 250MG/ 1.4MGHOVID BHD (IPOH SITE)-121 ,JALAN TUNKU ABDUL RAHMAN , 30010 IPOH , PERAK , MALAYSIA MALAYSIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2013
816NDA/MAL/HDP/1299SANCE LABORATORIES PVT LTDDELMAW ENTERPRISES LIMITEDSANAXONE PLUS-1000CEFTRIAXONE+SULBACTAM1000MG+500MGSANCE LABORATORIES PRIVATE LTD-PB NO. 2 ELAPPUNKAL JN, KOOZLUVANAL , 686 523, PALA, KOTTAYAM DISTRICT, KERALA, INDIA. INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.5 G VIAL01/07/2012
817NDA/MAL/HDP/1300KOPRAN LIMITEDTATA UGANDA LIMITEDATENOLOL-100ATENOLOL100MGKOPRAN LIMITED-VILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X16.0X14.0 TABLET BLISTER01/07/1997
818NDA/MAL/HDP/1301HOVID BHDUNITED HEALTHCARE DISTRIBUTORS LTDCOSAMINE PLUSGLUCOSAMINE SULPHATE + CHONDROITIN SULPHATE250MG + 200MGHOVID BERHAD (CHEMOR SITE)--LOT 56442, 71/2, JALAN IPOH/CHEMOR 31200, PERAK. MALAYSIA MALAYSIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2013
819NDA/MAL/HDP/1302CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDHIPEN CAPSULESAMOXYCILLIN250MGSPARSH BIO-TECH PVT. LIMITED-PLOT NO. 1;SURVEY NO. 242/243/244,LAKHABAVAD,JAMNAGAR-361 006, INDIA.
INDIAORAL SOLID ORDINARY CAPSULES1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER01/07/1997
820NDA/MAL/HDP/1304MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDDIAPRIDE PLUS 2GLIMEPIRIDE+ METFORMIN1MG + 500MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2012
821NDA/MAL/HDP/1307MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDARBITEL 40TELMISARTAN40MGMICRO LABS LTD ..-57, SIPCOT INDUSTRIAL COMPLEX, HOSUR-635126, TAMIIL NADU INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2013
822NDA/MAL/HDP/1312BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDSLIPIZEM- 2.5DIAZEPAM2.5MGBLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIAINDIARECTAL SYSTEMIC PAEDIATRIC SUPPOSITORIES1.0X5.0 SUPPOSITORY BLISTER01/07/2007
823NDA/MAL/HDP/1315ZEE PHARMACEUTICALS LTDZEE PHARMACEUTICALS LIMITEDZESOZ-20ESOMEPRAZOLE20MGTHE MADRAS PHARMACEUTICALS..-NO. 137B, OLD MAHABALIPURAM ROAD, KARAPAKKAM, CHENNAI 600096 INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2016
824NDA/MAL/HDP/1319REMEDICA LTDGOODMAN INTERNATIONAL LTDZESTAVAL 200 F.C TABLETSALBENDAZOLE200MGREMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR CYPRUSORAL SOLID ORDINARY FILM-COATED TABLETS50.0X2.0 TABLET BLISTER,1.0X2.0 TABLET BLISTER07/01/97
825NDA/MAL/HDP/1324MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDTOOTH HEALMULTI INGREDIENTMULTI INGREDIENTTORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506INDIAORAL LIQUID ORDINARY LIQUIDS1.0X1.0X18.0 ML BOTTLE01/07/2005
826NDA/MAL/HDP/1325MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDLAMIVUDINE + ZIDOVUDINELAMIVUDINE + ZIDOVUDINE150MG + 300MGMACLEODS PHARMACEUTICALS LTD., NO. 25-27-PLOT NO. 25-26-27, SURVEY NO.366, PREMIER INDUSTRIAL ESTATE ., DAMAN - 396210, KACHIGAM, DAMAN INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X60.0 TABLET BOTTLE01/07/2016
827NDA/MAL/HDP/1326IDAKIMSY MEDS LTDCO-TRIMOXAZOLE 480MGCO-TRIMOXAZOLE480MGMEDOPHARM--34-B, INDUSTRIAL AREA, MALUR 563 160 KARNATAKE,INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X100.0 TABLET BLISTER01/07/2010
828NDA/MAL/HDP/1328GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDENGERIX-B VACCINEHEPATITIS B SURFACE ANTIGEN20MCG/MLGLAXOSMITHKLINE BOILOGICALS-S.A RUE DE I'INSTITUT 89 B-1330 RIXENSARTBELGIUMPARENTERAL ORDINARY VIALS1.0X10.0X1.0 ML VIAL (1 DOSE),1.0X25.0X1.0 ML VIAL (1 DOSE)01/07/1997
829NDA/MAL/HDP/1330IPCA LABORATORIES LTDMEDVIN PHARMA LIMITEDRAPICLAV-625AMOXYCILLIN+CLAVULANIC ACID500MG+125MGIPCA LABORATORIES LTD,.-PLOT 69 TO 72 (B), SECTOR II, KASEZ, GANDHIDHAM - 370230, GUJARAT INDIAORAL SOLID ORDINARY TABLETS1.0X5.0X2.0 TABLET STRIP,1.0X7.0X3.0 TABLET STRIP01/07/2003
830NDA/MAL/HDP/1331ROYAL GROUPABACUS PHARMA (AFRICA) LIMITEDBETADERM N OINTMENTBETAMETHASONE VALERATE + NEOMYCIN0.1%W/W + 0.5%W/WATCO LABORATORIES PVT LTD-B-18,S.I.T.E KARACHI 75700, PAKISTAN PAKISTANTOPICAL EXTERNAL OINTMENTS1.0X15.0 G TUBE,1.0X5.0 G TUBE01/07/1997
831NDA/MAL/HDP/1334MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDOSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATE30MGMYLAN LABORATORIES LTD -- PLOT NO. H-12 & H-13 MIDCWALUJ INDUSTRIAL AREA AURANGABAD 431136 MAHARASTRAINDIAORAL SOLID ORDINARY CAPSULES1.0X10.0 CAPSULE BLISTER,1.0X30.0 CAPSULE CONTAINER01/07/2016
832NDA/MAL/HDP/1335INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDPREGATASPREGABALIN75MGINTAS PHARMACEUTICALS LTD-CAMP ROAD SELAQUI DEHRADUNINDIAORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER01/07/2012
833NDA/MAL/HDP/1336MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDOSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATE45MGMYLAN LABORATORIES LTD -- PLOT NO. H-12 & H-13 MIDCWALUJ INDUSTRIAL AREA AURANGABAD 431136 MAHARASTRAINDIAORAL SOLID ORDINARY CAPSULES1.0X10.0 CAPSULE BLISTER, CAPSULE CONTAINER01/07/2015
834NDA/MAL/HDP/1338LEBEN LABORATORIES PVT LTDANDYCO PHARMACY (UGANDA) LTDGRISEBEN 500GRISEOFULVIN500 MGLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2016
835NDA/MAL/HDP/1341AUROLABSWASTIK PHARMACEUTICAL LTDG-FLOXGATIFLOXACIN SESQUIHYDRATE0.3%W/VAUROLAB-NO 1 SIVAGANGAI MAIN ROAD, VEERAPANJAN MADURAI – 625 020 TAMIL NADU, INDIA INDIAOPHTHALMIC LIQUIDS1.0X5.0 ML VIAL01/07/2016
836NDA/MAL/HDP/1342KOTRA PHARMA (M) SDN BHDABACUS PHARMA (AFRICA) LIMITEDAXCEL CEPHALEXIN 250CEPHALEXIN MONOHYDRATE250MGKOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA MALAYSIAORAL SOLID ORDINARY CAPSULES1.0X100.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER01/07/2008
837NDA/MAL/HDP/1343MICRO LABS LTDPHARMA VILLE LIMITEDPRAZIQUANTELPRAZIQUANTEL600MGMICRO LABS LIMITED .,-92, SIPCOT, HOSUR 635126 MICRO LABS LIMITED, BOMMASANDRA (ML07),-PLOT 121-124, IV PHASE KIADB, BOMMASANDRA IND. AREA, JIGNI LINK ROAD INDIAORAL SOLID ORDINARY TABLETS1.0X500.0 TABLET CONTAINER01/07/2013
838NDA/MAL/HDP/1345ALKEM LABORATORIES LIMITEDABACUS PHARMA (AFRICA) LIMITEDSWICH-200CEFPODOXIME200MGALKEM LABORATORIES LTD-VILLAGE – THANA, BADDI TEHSIL – NALAGARH, DIST-SOLAN (HP), INDIA – 173205 INDIAORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER01/07/2010
839NDA/MAL/HDP/1346ASTRA PHARMA LTDASTRA PHARMA (U) LIMITEDASIXFUROSEMIDE40MGASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER01/07/2010
840NDA/MAL/HDP/1347MICRO LABS LIMITEDLABOREX UGANDA LIMITEDORNILOXORNIDAZOLE + OFLOXACIN500MG + 200MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X10.0 TABLET BLISTER01/07/2010
841NDA/MAL/HDP/1348TORRENT PHARAMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.VALPARIN CHRONO 500SODIUM VALPROATE (CONTROLLED RELEASE)500MGTORRENT PHARMACEUTICAL LTD-AHMEDABAD-MEHSANA HIGHWAY,TALUKA-KADI,DIST.MEHSANA,INDRAD-382721 INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET STRIP01/07/2009
842NDA/MAL/HDP/1351MEDLEY PHARMACEUTICALS LTDMEDVIN PHARMA LIMITEDATORINATORVASTATIN CALCIUM20MGMEDLEY PHARMACEUTICALS LTD,-PLOT 18 & 19 SURVEY NO 378/7 & 379/ 2&3 ZARI CAUSEWAY ROAD KACHIGAM INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER07/01/14
843NDA/MAL/HDP/1352MEDLEY PHARMACEUTICALS LTDMEDVIN PHARMA LIMITEDPLATFREECLOPIDOGREL75MGMEDLEY PHARMACEUTICALS LTD-PLOT NO.18 AND 19, SURVEY NO.378/8 & 379/2, KEBRA INDUSTRIAL ESTATE, KACHIGAM, DAMAN-396210 INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2014
844NDA/MAL/HDP/1353MEDLEY PHARMACEUTICALS LTDMEDVIN PHARMA LIMITEDKITPYLO - CLANSOPRAZOLE + TINIDAZOLE + CLARITHROMYCIN30MG +500MG + 250MGMEDLEY PHARMACEUTICALS LTD,-PLOT 18 & 19 SURVEY NO 378/7 & 379/ 2&3 ZARI CAUSEWAY ROAD KACHIGAM INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X7.0X1.0X6.0 TABLET BLISTER (BLISTER CONTAINS 2 CAPSULES AND 4 TABLETS)01/07/2015
845NDA/MAL/HDP/1355PIRAMAL HEALTHCARE LTDTATA UGANDA LIMITEDSEVOFLURANESEVOFLURANE100% V/VPIRAMAL ENTERPRISES LTD, INDIA-DIGWAL VILLAGE KOHIR MENDAL MEDAK DISTRICT,ANDHRA PRADESH INDIAOTHER SYSTEMIC LIQUID INHALATIONS1.0X250.0 ML BOTTLE01/07/2010
846NDA/MAL/HDP/1359KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDDIFENAC-100 SRDICLOFENAC SODIUM100MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD-PLOT M 444B STRETCHER ROAD NTINDAUGANDAORAL SOLID RETARD CAPSULES1.0X10.0 CAPSULE BLISTER01/07/2016
847NDA/MAL/HDP/1360CIPLA LTDQUALITY CHEMICALS LTD - HUMANABAMUNE-L BABYABACAVIR SULPHATE + LAMIVUDINE60MG + 30MGCIPLA LTD-UNIT I & II A-32 & A-42 MIDC PATALGANGA 410220 DIST-RAIGAD, MAHARASHTRA INDIA INDIAORAL SOLID ORDINARY SOLUBLE TABLETS1.0X60.0 TABLET CONTAINER01/07/2016
848NDA/MAL/HDP/1361SWISS PARENTERALS PVT. LTD.SHREEJI PHARMACEUTICALS LIMITEDFALCI CAREARTESUNATE120MGSWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIAINDIAPARENTERAL ORDINARY DRY VIALS1.0X30.0 MG VIAL + 1*5ML OF 0.9%W/V NACL AMPOULE + 1*1ML OF 5%W/V NAHCO3 AMPOULE01/07/2016
849NDA/MAL/HDP/1362MICRO LABS LIMITEDLABOREX UGANDA LIMITEDBACTOCLAV-1000AMOXICILLIN + CLAVULANATE875 MG + 125 MGMICRO LABS LIMITED -PLOT 16 VEERASANDRA IND. AREA,ANEKAL TALUK,BANGALORE INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X7.0 TABLET STRIP01/07/2013
850NDA/MAL/HDP/1367DAWA LIMITEDSUPER MEDIC LTDACEPARACECLOFENAC + PARACETAMOL100 MG + 500 MGDAWA LTD-BABA DOGO ROAD RUARAKAKENYAORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER01/07/2013
851NDA/MAL/HDP/1368PHARMACIE BETHELABACUS PARENTERAL DRUGS LIMITEDD5GLUCOSE5%W/VABACUS PARENTERAL DRUGS LIMITED-BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA. UGANDAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X500.0 ML BOTTLE,1.0X250.0 ML BOTTLE01/07/2010
852NDA/MAL/HDP/1369MEDIPHARM (EA) LTDMEDIPHARM INDUSTRIES (E.A) LTDORALYTE CO-PACK ORANGE FLAVOURDT ZINC-20 + ORAL REHYDRATION SALTS (ORS)20GMEDICAMEN BIOTECH LTD,.-SP-1192 A&B PHASE IV INDUSTRIAL AREA BHIWADI 301019 DIST. ALWAR (RAJASTHAN) - INDIA MEDIPHARM INDUSTRIES( EA) LTD-PLOT 65 KAKAJJO ROAD BWEYOGERERE P.O.BOX 6218,KAMPALA,UGANDA AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL LIQUID ORDINARY SOLUBLE POWDERS1.0X2.0X20.8 G SACHET + 1.0 *10.0 TABLET BLISTER01/07/2016
853NDA/MAL/HDP/1370PHARMACIE BETHELABACUS PARENTERAL DRUGS LIMITEDSTERILIZED WATER FOR INJECTIONWATER FOR INJECTIONNEUTRALABACUS PARENTERAL DRUGS LIMITED-BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA. UGANDAPARENTERAL ORDINARY AMPOULES1.0X5.0 ML AMPOULE,1.0X10.0 ML AMPOULE,1.0X7.5 ML AMPOULE07/01/10
854NDA/MAL/HDP/1374HILTON PHARMA (PVT) LTDHEALTHCARE LTD.VALODIN -125CEPHADRINE125MG/5MLHILTON PHARMA (PVT) LTD-PLOT 13 SECTOR 15 KORANGI INDUSTRIAL AREA KARACHIPAKISTANORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE01/07/2003
855NDA/MAL/HDP/1375HILTON PHARMA (PVT) LTDHEALTHCARE LTD.VALODIN CAPSULESCEPHADRINE250MGHILTON PHARMA (PVT) LTD-PLOT 13 SECTOR 15 KORANGI INDUSTRIAL AREA KARACHIPAKISTANORAL SOLID ORDINARY CAPSULES1.0X3.0X4.0 CAPSULE BLISTER01/07/2001
856NDA/MAL/HDP/1377OTSUKA PHARMACEUTICAL INDIA PRIVATE LIMITEDREDDYS PHARMA LIMITEDWATER FOR INJECTIONWATER FOR INJECTIONN/AOTSUKA PHARMACEUTICAL INDIA PRIVATE LTD-VILLAGE – VASANA – CHACHARWADIP, TAL: SANAND, AHMADABAD INDIAPARENTERAL ORDINARY AMPOULES1.0X10.0 ML AMPOULE07/01/14
857NDA/MAL/HDP/1380KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDHYCORT CREAMHYDROCORTISONE1%W/WKAMPALA PHARMECEUTICALS INDUSTRIES LTD.-PLOT M444B STRETCHER RD, NTINDA KLA UGANDA UGANDATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE,1.0X30.0 G TUBE01/07/1997
858NDA/MAL/HDP/1381CIPLA LTDQUALITY CHEMICALS LTD - HUMANLAMIVUDINE,/ ZIDOVUDINE TABLETSLAMIVUDINE,+ ZIDOVUDINE150MG+300MGCIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X60.0 TABLET BOTTLE01/07/2007
859NDA/MAL/HDP/1382HOVID BERHADUNITED HEALTHCARE DISTRIBUTORS LTDINOX CAPSULESITRACONAZOLE100MGHOVID BHD-LOT 56442, 7.5 MILE JALAN IPOH/CHEMO 31200 CHEMOR, PERAK MALAYSIA MALAYSIAORAL SOLID ORDINARY CAPSULES1.0X7.0X4.0 CAPSULE BLISTER01/07/2012
860NDA/MAL/HDP/1383HOVID BHDUNITED HEALTHCARE DISTRIBUTORS LTDKETOFEN GELKETOPROFEN2.5%W/WHOVID BHD (IPOH SITE)-121 ,JALAN TUNKU ABDUL RAHMAN , 30010 IPOH , PERAK , MALAYSIA MALAYSIATOPICAL EXTERNAL GELS AND SOLS1.0X30.0 G CONTAINER01/07/2013
861NDA/MAL/HDP/1384CIPLA LTDQUALITY CHEMICALS LTD - HUMANLAMIVUDINE AND ZIDOVUDINE TABLETSLAMIVUDINE + ZIDOVUDINE30MG + 60MGCIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA INDIAORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS1.0X60.0 TABLET BOTTLE01/07/2013
862NDA/MAL/HDP/1387INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDLAN-30LANSOPRAZOLE30MGINTAS PHARMACEUTICALS LTD-CAMP ROAD SELAQUI DEHRADUNINDIAORAL SOLID ORDINARY CAPSULES1.0X1.0X5.0X10.0 CAPSULE STRIP01/07/2004
863NDA/MAL/HDP/1389UNIVERSAL CORPORATION LTDHARLEYS UGANDA LIMITEDNELSTATNYSTATIN100000 I.U/MLUNIVERSAL CORPORATION LIMITED -PLOT 13777 KIKUYU ROAD, KIKUYU TOWN, PAST POST OFFICE KENYAORAL TOPICAL SUSPENSIONS1.0X30.0 ML BOTTLE01/07/2010
864NDA/MAL/HDP/1390ASTRA ZENECAMACNAUGHTON LIMITEDCRESTORROSUVASTATIN CALCIUM5MGIPR PHARMACEUTICALS INC,-LOT 17 INDUSTRIAL PARK PUERTO RICO, SAN ISIDRO, PUERTO RICO PUERTO RICOORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X14.0 TABLET BLISTER07/01/10
865NDA/MAL/HDP/1392ASTRA ZENECAMACNAUGHTON LIMITEDZOLADEXGOSERELIN3.6MGASTRA ZENECA UK LIMITED-ASTRAZENECA UK LIMITED SILK ROAD BUSINESS PARK, MACCLES FIELD,CHESHIRE SK 10 2NA, UNITED KINGDOMPARENTERAL ORDINARY PRE-FILLED SYRINGES1.0X1.0 PREFILLED SYRINGE CARTON01/07/1997
866NDA/MAL/HDP/1393SANCE LABORATORIES PVT LTDDELMAW ENTERPRISES LIMITEDSANFURCEFUROXIME500MGSANCE LABORATORIES PRIVATE LTD-PB NO. 2 ELAPPUNKAL JN, KOOZLUVANAL , 686 523, PALA, KOTTAYAM DISTRICT, KERALA, INDIA. INDIAORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER07/01/13
867NDA/MAL/HDP/1394SANCE LABORATORIES PVT LTDDELMAW ENTERPRISES LIMITEDSANPIME -1000CEFEPIME1000MGSANCE LABORATORIES PRIVATE LTD-PB NO. 2 ELAPPUNKAL JN, KOOZLUVANAL , 686 523, PALA, KOTTAYAM DISTRICT, KERALA, INDIA. INDIAPARENTERAL ORDINARY DRY VIALS1.0X15.0 ML VIAL01/07/2010
868NDA/MAL/HDP/1395ASTRA ZENECA ABMACNAUGHTON LIMITEDNEXIUM 40MG IVESOMEPRAZOLE40MG/5MLASTRA ZENECA--KVARNBERGAGATAN12, SE-151 SODERTALIJE SWEDENPARENTERAL ORDINARY VIALS1.0X1.0X5.0 ML VIAL,1.0X10.0X5.0 ML VIAL01/07/2010
869NDA/MAL/HDP/1397ASTRAZENECAMACNAUGHTON LIMITEDPLENDILFELODIPINE10MGASTRAZENECA AB,-GARTUNA & SNACKVIKEN STOCKHOLM SWEDENORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET CONTAINER01/07/2001
870NDA/MAL/HDP/1399CIPLA LTD.QUALITY CHEMICALS LTD - HUMANASTHALINSALBUTAMOL100MCG/DOSECIPLA LTD .-PLOT NO. 9, 10 AND 15, INDORE SPECIAL ECONOMIC ZONE, PHASE –II, PITHAMPUR, DISTRICT DHAR, PIN CODE: 454775, MADHYA PRADESH INDIALUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER1.0X200.0 METERED DOSE CANNISTER01/07/2010
871NDA/MAL/HDP/1400MEGA LIFESCIENCES (AUSTRALIA) PTY LTDABACUS PHARMA (AFRICA) LIMITEDPANFOR SR 500METFORMIN HYDROCHLORIDE500MGINVENTIA HEALTHCARE PRIVATE LIMITED-F1-F1/1, ADDITIONAL AMBERNATH MIDC, AMBERNATH
(EAST), DISTRICT THANE, 421 0506, DIST. THANE,
MAHARASHTRA, INDIA.
INDIAORAL SOLID RETARD TABLETS1.0X5.0X20.0 TABLET BLISTER07/01/15
872NDA/MAL/HDP/1402MEGA LIFESCIENCES (AUSTRALIA) PTY LTDABACUS PHARMA (AFRICA) LIMITEDPANFOR SR 1000METFORMIN HYDROCHLORIDE1000MGINVENTIA HEALTHCARE PRIVATE LIMITED-F1-F1/1, ADDITIONAL AMBERNATH MIDC, AMBERNATH
(EAST), DISTRICT THANE, 421 0506, DIST. THANE,
MAHARASHTRA, INDIA.
INDIAORAL SOLID RETARD TABLETS1.0X5.0X20.0 TABLET BLISTER07/01/15
873NDA/MAL/HDP/1403VHB MEDI SCIENCES LTDLLOYDS PHARMACY LIMITEDDOMAXIN-RD 10MGDOXORUBICIN HCL10MGVHB MEDI SCIENCES LTD-PLOT 20, 21, 22 & 49,50, 51. INTEGRATED INDUSTRIAL AREA SECTOR 5, RUDRAPUR, UTTARAKHAND - INDIA INDIAPARENTERAL ORDINARY VIALS1.0X10.0 MG VIAL07/01/10
874NDA/MAL/HDP/1404MIRACALUS PHARMA PVT.LTDAIVEEN (U) LIMITEDNAPRODOX-10DOXORUBICIN HCL100MGNAPROD LIFE SCIENCES (PVT) LIMITED-PLOT G-17/1 MIDC TARAPUR BOISAR, DIST. THANE-401506 MAHARASTRA, INDIA INDIAPARENTERAL ORDINARY VIALS1.0X5.0 ML VIAL01/07/2010
875NDA/MAL/HDP/1406LEBEN LABORATORIES PVT LTDANDYCO PHARMACY (UGANDA) LTDCEBAY DRY SYRUPCEFIXIME TRIHYDRATE50MG/5MLLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE01/07/2014
876NDA/MAL/HDP/1407PHARMATHEN S.AGOODMAN INTERNATIONAL LTDBELIFAXOMEPRAZOLE20MGPHARMATHEN S.A-6,DERVENAKION STR,PALLINI,AHICA GREECE GREECEORAL SOLID ORDINARY CAPSULES1.0X14.0 CAPSULE BOTTLE01/07/1997
877NDA/MAL/HDP/1408TORRENT PHARAMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.ROSUCORROSUVASTATIN20MGTORRENT PHARMACEUTICALS LTD-VILLAGE. BHUD-MAKHNU MAJRA, TEHSIL: BADDI 173205 DIST SOLAN (H.P) INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2011
878NDA/MAL/HDP/1409SURGE LAB (PVT) LIMITEDJEET PHARMACEUTICALS LIMITEDROMYCINAZITHROMYCIN200MG/5MLNABIQASIM INDUSTRIES (PVT) LTD--17/24,KORANGI INDUSTRIAL AREA, KORANGI, KARACHI- PAKISTAN. PAKISTANORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X1.0X15.0 ML BOTTLE01/07/2007
879NDA/MAL/HDP/1411LEBEN LABORATORIES PVT LTDANDYCO PHARMACY (UGANDA) LTDCIPIUMCHLORPHENIRAMINE4MGLEBEN LAB PVT LTD-L4 PHASE 111 MIDCS AKOLA 444104 MAHARASTRA INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X20.0 TABLET BLISTER01/07/2011
880NDA/MAL/HDP/1413BETA HEALTHCARE INTERNATIONAL LTDBETA HEALTHCARE UGANDA LIMITEDPODINE MOUTH WASHPOVIDONE IODINE0.1%W/VBETA HEALTHCARE INTERNATIONAL LTD - -PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYA KENYAORAL TOPICAL LIQUIDS1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE07/01/14
881NDA/MAL/HDP/1414UNIQUE PHARMACEUTICALS LABORATORIESPLANET PHARMACEUTICALS UGANDA LTDDICLORAN SR TABLETSDICLOFENAC SODIUM100MGUNIQUE PHARMACEUTICAL LABS LIMITED. .-215-216, 216-219, 304-308, GIDC PANOLI 394116-GUJARAT INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2016
882NDA/MAL/HDP/1415ASTRA ZENECAMACNAUGHTON LIMITEDATACANDCANDESARTAN32MGASTRA ZENECA SWEDEN OPERATIONS-TABLET PRODUCTION SE-151 85, GARTUNAVAGEN, SODERTALJE
SWEDENORAL SOLID ORDINARY TABLETS1.0X2.0X14.0 TABLET BLISTER01/07/2011
883NDA/MAL/HDP/1417GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDMILICAL TABLETSCALCIUM CITRATE + VITAMIN D31000MG +200 I.UGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2001
884NDA/MAL/HDP/1418NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDAMINOPHYLLINE TABLETSAMINOPHYLLINE100MGNEM LABORATORIES PVT LTD-133 KRISHNA INDUSTRIAL ESTATE VASAI (E) DIST THANE 401 210 MAHARASHTRAINDIAORAL SOLID ORDINARY TABLETS1.0X100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER01/07/2011
885NDA/MAL/HDP/1419GLOBAL NAPI PHARMACEUTICALSWIDE SPECTRUM ENTERPRISES (U) LIMITEDSINOPRIL 10LISINOPRIL10MGGLOBAL NAPI PHARMACEUTICALS -2ND INDUSTRIAL ZONE, NO.40, ST. NO 18, 6TH OCTOBER, GIZA, EGYPTORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER01/07/2005
886NDA/MAL/HDP/1420IVEE INFUSIONS EPZ LTDASTRA PHARMA (U) LIMITEDSODIUM CHLORIDE + GLUCOSESODIUM CHLORIDE + GLUCOSE0.9%W/V + 5%W/VIVEE INFUSION EPZ LTD-ATHI RIVER EXPORT PROCESSING ZONE LR NO. 18474184 NAIROBIKENYAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X500.0 ML BOTTLE01/07/2016
887NDA/MAL/HDP/1423SANDOZ KENYA C/O NOVARTIS PHARMA SERVICES INCSURGIPHARM (U) LIMITEDCURAMAMOXYCILLIN + POTASSIUM CLAVULANATE500MG+125MGSANDOZ GMBH-BIOCHEMIESTRASSE 10, A6250 KUNDL, TYROL, AUSTRIA AUSTRIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X7.0X2.0 TABLET BLISTER01/07/2016
888NDA/MAL/HDP/1425LEBEN LABORATORIES PVT.LTDANDYCO PHARMACY (UGANDA) LTDL-TRIMCOTRIMOXAZOLE240MG/5MLLEBEN LABORATORIES PVT. LTD-L-4, PHASE –III, M.I.D.C, INDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X60.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE01/07/2007
889NDA/MAL/HDP/1426LEBEN LABORATORIES PVT.LTDANDYCO PHARMACY (UGANDA) LTDMETROLEBMETRONIDAZOLE200MGLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2015
890NDA/MAL/HDP/1427AGOG PHARMA LTD.GITTOES PHARMACEUTICALS LIMITEDTENA-50ATENOLOL50MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X28.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER01/07/2011
891NDA/MAL/HDP/1428UNIVERSAL CORPORATION LTDROYAL PHARMA 2011 LIMITEDDINAC-50DICLOFENAC SODIUM50 MGUNIVERSAL CORPORATION LTD.-CLUB ROAD, PAST KIKUYU POST OFFICE, P.O. BOX 1748-00902 KIKUYU TOWN KENYAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/07
892NDA/MAL/HDP/1431INTAS PHARMACUITICALS LTDNORVIK ENTERPRISES LIMITEDTORTAS 10TORSEMIDE10MGINTAS PHARMACEUTICALS LIMITED -CAMP ROAD, SELAQUI-248197,DEHRADUN UTTARAKHAND, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2013
893NDA/MAL/HDP/1432CIRON DRUGS & PHARMACEUTICALS PVT LTDRENE PHARMACY LTDCHLORAMPHENICOL EAR DROPSCHLORAMPHENICOL5%W/VCIRON DRUGS AND PHARMACEUTICALS PVT LTD-N-118 M.I.D.C, TAAPUR,BOISAR,DIST.THANE MAHARASHTRA INDIA INDIAOTIC DROPS1.0X10.0 ML VIAL01/07/2007
894NDA/MAL/HDP/1433BAYER PHARMA AGSURGIPHARM (U) LIMITEDNORISTERATNORETHISTERONE ENANTATE200MGBAYER PHARMA A.G-MULLERSTRASSE 178, 13353 BERLIN, GERMANY GERMANYPARENTERAL ORDINARY VIALS1.0 ML PRE- FILLED SYRINGE,1.0X100.0X1.0 ML VIAL01/07/1997
895NDA/MAL/HDP/1436MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDCONCOR 10BISOPROLOL HEMIFUMARATE10MGMERCK KGAA-250 FRANKFRUTER STRASSE 250-64293 DARMSTADT WINTHROP PHARMACEUTICALS(PTY) LTD,-315 WATLOO ROAD,WATLOO,PRETORIA,SOUTHAFRICA (FPP SECONDARY PACKAGING,FPP RELEASE/QC TESTING SITE) GERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2014
896NDA/MAL/HDP/1445CADILA PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.AXONE 1000CEFTRIAXONE SODIUM1000MGCADILA PHARMACEUTICALS LIMITED-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA INDIAPARENTERAL ORDINARY DRY VIALS1.0X1000.0 MG VIAL01/07/2003
897NDA/MAL/HDP/1446RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDVITAMIN B COMPLEXVITAMINS B1 + B2 + B6 + NIACINAMIDE0.5 MG + 0.5MG + 7.5MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA UGANDAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER01/07/2015
898NDA/MAL/HDP/1447EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDVITONA PLUSVITAMINS + MINERALSMULTI-INGREDIENTEGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREAEGYPTORAL SOLID ORDINARY CAPSULES1.0X2.0X6.0 CAPSULE BLISTER01/07/2014
899NDA/MAL/HDP/1449SHAIGAN PHARMACEUTICALS (PVT) LTDHEALTHCARE LTD.ZEPAR SUSPENSIONALBENDAZOLE200MG/5MLSHAIGAN PHARMACEUTICALS (PVT) LTD-14TH KM, ADYALA ROAD, RAWALPINDI-PAKISTAN PAKISTANORAL LIQUID ORDINARY SUSPENSIONS1.0X10.0 ML BOTTLE01/07/2000
900NDA/MAL/HDP/1450GLAXOSMITHKLINE LIMITED LIKONIUNITED HEALTHCARE DISTRIBUTORS LTDVOLTAREN EMULGEL 1%DICLOFENAC DIETHYLAMMONIUM1%W/VNOVARTIS CONSUMER HEALTH SA-CH-1260 NYON SWTZERLANDSWITZERLANDTOPICAL EXTERNAL GELS AND SOLS1.0X20.0 G TUBE,1.0X50.0 G TUBE07/01/97
901NDA/MAL/HDP/1451NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDVOLTAREN INJECTIONDICLOFENAC25MG/MLNOVARTIS PHARMA STEIN AG-SCHAFFHARVSERTRASSE CH-4332 STEIN SWITZERLAND.SWITZERLANDPARENTERAL ORDINARY AMPOULES1.0X3.0 ML AMPOULE01/07/1997
902NDA/MAL/HDP/1452ASTRA ZENECAMACNAUGHTON LIMITEDZESTORETICLISINOPRIL/HYDROCHLOROTHIAZIDE20MG/12.5MGASTRAZENECA MACCLESFIELD-CHESHIREUNITED KINGDOMORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X14.0 TABLET BLISTER01/07/1997
903NDA/MAL/HDP/1453ZEE PHARMACEUTICALS LTDZEE PHARMACEUTICALS LIMITEDZESOZ-40ESOMEPRAZOLE40MGMADRAS PHARMACEUTICALS -137-B, OLD MAHABALIPURAM ROAD, KARAPAKKAM, CHENNAI – 600 096, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2016
904NDA/MAL/HDP/1454RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDPAINEXPARACETAMOL + ASPIRIN + CAFFEINE500MG + 400MG + 50 MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA UGANDAORAL SOLID ORDINARY TABLETS1.0X25.0X4.0 TABLET STRIP01/07/2003
905NDA/MAL/HDP/1457NABIQASIM INDUSTRIES (PVT) LIMITEDJEET PHARMACEUTICALS LIMITEDDYSEN FORTESECNIDAZOLE1000MGNABIQASIM INDUSTRIES (PVT) LIMITED-17/24, KORANGI INDUSTRIAL AREA, KARACHI, PAKISTAN PAKISTANORAL SOLID ORDINARY TABLETS1.0X2.0 TABLET BLISTER01/07/2006
906NDA/MAL/HDP/1458STRIDES SHASUN LIMITEDDELMAW ENTERPRISES LIMITEDCLAVICIN INJECTIONAMOXICILLIN + POTASSIUM CLAVULANATE1.2GSTRIDES ARCOLAB LTD -BILEKAHALLI OPP IIM BANNERGHATTA ROAD
BANGALORE 560076
INDIA
INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.2 G VIAL01/07/2013
907NDA/MAL/HDP/1459NVS KENYA LTDSURGIPHARM (U) LIMITEDTASIGNA 200NILOTINIB200MGNORVATIS PHARMA STEIN AG-SCHAFF HAUSER STRASSE 4332, STEIN - SWITZERLAND SWITZERLANDORAL SOLID ORDINARY CAPSULES1.0X2.0X14.0 CAPSULE BLISTER01/07/2014
908NDA/MAL/HDP/1460VENUS REMEDIES LIMITEDAARON PHARMACEUTICALS LTDPARIN EENOXAPARIN80MGVENUS REMEDIES LTD --UNIT II HILL TOP INDUSTRIAL ESTATE JHARMAJRI EPIP PHASE I BHATOLI KALAN BADDI (H.P)INDIAPARENTERAL ORDINARY PRE-FILLED SYRINGES1.0X10.0X2.0 ML PRE- FILLED SYRINGE01/07/2009
909NDA/MAL/HDP/1463ARISTO PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDARISTOZYME LIQUIDDIASTASE+PEPSIN50MG+10MGARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO. II, MANDIDEEP-462046, DIST. - RAISEN, MADHYA PRADESH, INDIA. INDIAORAL LIQUID ORDINARY LIQUIDS1.0X200.0 ML BOTTLE01/07/2015
910NDA/MAL/HDP/1464ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDORNIDAORNIDAZOLE500MGARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO. II, MANDIDEEP-462046, DIST. - RAISEN, MADHYA PRADESH, INDIA. INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER01/07/2014
911NDA/MAL/HDP/1465NORVATIS PHARMA AGSURGIPHARM (U) LIMITEDVOLTFAST 50MGDICLOFENAC POTASSIUM50MGMIPHARM S.P.A -VIA BERNARDO QUARANTA, 12-20141, MILANO ITALY. ITALYORAL LIQUID ORDINARY SOLUBLE POWDERS1.0X3.0 SACHET CARTON01/07/2014
912NDA/MAL/HDP/1468CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDOCID CAPSULESOMEPRAZOLE20MG S KANT HEALTHCARE LTD-PLOT NO. 1802-1805, G.I.D.C. PHASE III, VAPI 396 195. GUJARAT. CADILA HEALTH CARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA INDIAORAL SOLID RETARD CAPSULES1.0X10.0X10.0 CAPSULE STRIP07/01/98
913NDA/MAL/HDP/1469VOGEN LABORATORIES LTDBUFFALO HEALTH CARE LTDDURAMOX 125AMOXICILLIN125MG/5MLVOGEN LABORATORIES LTD-70, M.HERACLEOUS STR. AYIOS ATHANASIOS INDUSTRIAL AREA, LIMASSOL, CYPRUS CYPRUSORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE01/07/2007
914NDA/MAL/HDP/1471PT SAMBE FARMAMEDVIN PHARMA LIMITEDTEMIRALACICLOVIR30MG/GPT SANBE FARMA JI INDUSTRI-NO.8 KOMPLEKS INDUSTRI CIMAREME PADALARANG BANDUNGINDONESIAOPHTHALMIC OINTMENTS1.0X3.5 G TUBE01/07/2011
915NDA/MAL/HDP/1472GLAXO WELLCOME (KENYA) LTDUNITED HEALTHCARE DISTRIBUTORS LTDFORTUM INJECTIONCEFTAZIDIME1GMGLAXOSMITHKLINE LTD MANUFACTURING SPA-VERONAITALYPARENTERAL ORDINARY VIALS1.0X1.0 G VIAL01/07/1997
916NDA/MAL/HDP/1474AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGODICDICLOFENAC DIETHYLAMINE1%W/WAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIATOPICAL EXTERNAL GELS AND SOLS1.0X30.0 G TUBE01/07/2016
917NDA/MAL/HDP/1476AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDSEPTOLSILVER SULFADIAZINE + CHLORHEXIDINE GLUCONATE1%W/W + 0.20W/WAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIATOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE01/07/2016
918NDA/MAL/HDP/1478AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDKAMAGRASILDENAFIL50MGAJANTA PHARMA LIMITED PAITHAN-MANUFACTURING UNIT B-4/5/6 MIDC PAITHAN DISTRICT AURANGABAD 431 148 MAHARASTRA STATE INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X1.0X4.0 TABLET BLISTER01/07/2001
919NDA/MAL/HDP/1481ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDASTROGYLMETRONIDAZOLE200MGASTRA LIFE CARE (INDIA) PVT LIMITED-57/P RAJODA
382220 BAVIA
AHMEDABAD INDIA
INDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER01/07/1997
920NDA/MAL/HDP/1482SANOFI PASTEURLABOREX UGANDA LIMITEDSTAMARIL PASTEURYELLOW FEVER VIRUS 17D-204 STRAIN(LIVE ATTENUATED)NLT 1000 I.USANOFI PASTEUR-1541 AVENUE MARCEL MERIEUX, 69280 MARCY, LETOILE SANOFI PASTEUR S.A-2,AVENUE PONT PASTEUR 69007 LYON-FRANCE(BUSINESS ADDRESS) FRANCEPARENTERAL ORDINARY VIALS1.0X1.0 DOSE VIAL + 0.5ML OF SOLVENT IN PRE-FILLED SYRINGE,1.0X10.0X10.0 DOSE VIAL + 1*10*10 DOSE AMPOULE OF NS01/07/1997
921NDA/MAL/HDP/1484SHAIGAN PHARMACEUTICALS LTDHEALTHCARE LTD.CLYCIN.VCLINDAMYCIN2%W/WSHAIGAN PHARMACEUTICALS (PVT) LIMITED-14 KM ADYALA RD, RAWALPINDI, PAKISTAN PAKISTANTOPICAL EXTERNAL OTHER CREAMS1.0X40.0 G TUBE + APPLICATOR01/07/2004
922NDA/MAL/HDP/1485UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTDWIDE SPECTRUM ENTERPRISES (U) LIMITEDDICLOFEN 25DICLOFENAC25MGUNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD-P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSINGJORDANRECTAL SYSTEMIC SUPPOSITORIES1.0X2.0X5.0 SUPPOSITORY BLISTER01/07/2011
923NDA/MAL/HDP/1486ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDAMPIMAX-1AMPICILLIN1GREYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG PROVINCE P.R. 256100 CHINAPARENTERAL ORDINARY DRY VIALS1.0X50.0X1.0 G VIAL01/07/2011
924NDA/MAL/HDP/1487BAYER PHARMA AGSURGIPHARM (U) LIMITEDSCHERIPROCT SUPPOSITORIESPREDNISOLONE CAPROATE/ CINCHOCAINE HYDROCHLORIDE1.3MG/ 1MGBAYER HEALTH CARE MANUFACTURING S.R.I -S.P.A VIA SCHERING,21 20090 SEGRATE (MILAN) ITALY ITALYRECTAL SYSTEMIC SUPPOSITORIES1.0X12.0 SUPPOSITORY STRIP01/07/1997
925NDA/MAL/HDP/1488ERIS LTDBENLE CONSULT LIMITEDDICLO-DENK 100 RECTALDICLOFENAC SODIUM100MGHAUPT PHARMA WULFING GMBH.-BETHELNER LANDSTR. 18, 31028 GRONAU GERMANYRECTAL SYSTEMIC ADULT SUPPOSITORIES10.0X1.0X2.0X5.0 SUPPOSITORY STRIP,1.0X5.0 SUPPOSITORY STRIP01/07/2000
926NDA/MAL/HDP/1489GUILIN PHARMACEUTICAL CO.LTDSTAR PHARMACEUTICALS LTDPARACETAMOLPARACETAMOL500MGGUILIN PHARMACEUTICAL CO. LTD-NO. 17 SHANGHAI ROAD, GUILIN 541002, GUANXI CHINA CHINAORAL SOLID ORDINARY TABLETS1.0X500.0 TABLET CONTAINER01/07/2010
927NDA/MAL/HDP/1490GUILIN PHARMACEUTICAL CO.LTDSTAR PHARMACEUTICALS LTDMETRONIDAZOLE TABLETS BPMETRONIDAZOLE TABLETS BP200MGGUILIN PHARMACEUTICALS CO. LTD-NO.7 SHANGHAI ROAD GUILIN 541002, GUANGXI, CHINA CHINAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER01/07/2010
928NDA/MAL/HDP/1492ERIS LTDBENLE CONSULT LIMITEDDICLO-DENK 75 INJECTIONDICLOFENAC SODIUM25MG/MLHAUPT PHARMA WULFING GMBH;--BETHELNER LANDSTR. 18, 31028 GRONAULLEIRE, GERMANY. GERMANYPARENTERAL ORDINARY AMPOULES1.0X10.0X3.0 ML AMPOULE07/01/98
929NDA/MAL/HDP/1493AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDKOACT 1000AMOXICILLIN/CLAVULANATE POTASSIUM875MG/125MGAUROBINDO PHARMA LTD-UNIT VII (SEZ), PLOT NO.S1, GREEN INDUSTRIAL PARK,
POLEPALLY (V) JEDCHERIA (M), MAHABOOB NAGAR
INDIAORAL SOLID RETARD TABLETS1.0X3.0X5.0 TABLET BLISTER01/07/2007
930NDA/MAL/HDP/1494FERRER INTERNACIONAL S.ALABOREX UGANDA LIMITEDPEITEL 0.25%PREDNICARBATE0.25%W/WFERRER INTERNACIONAL, S.A-JOAN BUCSALA 1-9, 08173 SANT CUGAT DEL VALLES, BARCELONA, SPAIN SPAINTOPICAL EXTERNAL CREAMS1.0X30.0 G TUBE07/01/13
931NDA/MAL/HDP/1495WOCKHARDT LTDSTAR PHARMACEUTICALS LTDPELOX-400PEFLOXACIN400MGWOCKHARDT LIMITED --PLOT 57 VILLAGE KUNJHAL, JHAMAJRI, BAROTIWALA, BADDI, TEHSIL-NALAGARH, DISTRICT SOLAN, 174103 HIMACHAL PRADESH, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET STRIP01/07/1997
932NDA/MAL/HDP/1497LABORATORY AND ALLIED LTDHARLEYS UGANDA LIMITEDLAEOVATE CREAMBETAMETHASONE VALERATE0.1%W/WLABORATORY & ALLIED LTD--PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, MOMBASA ROAD P.O. BOX 42875, GPO 00100, NAIROBI, KENYA KENYATOPICAL EXTERNAL CREAMS1.0X1.0X15.0 G TUBE01/07/1997
933NDA/MAL/HDP/1499GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDPROMETHAZINEPROMETHAZINE HYDROCHLORIDE25MG/MLNINGBO DAHONGYING PHARMACEUTICALS LTD- NO. 396 MINCHINAPARENTERAL ORDINARY AMPOULES1.0X2.0 ML AMPOULE01/07/2005
934NDA/MAL/HDP/1500MERCK SHARP & DOHME BVPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDATRIPLAEFAVIRENZ+EMTRICITABINE + TENOFOVIR600MG +200MG+300MGPATHEON INC-MISSISSAUGA,ON L5N 7K9 CANADA NETHERLANDSORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET CONTAINER01/07/2008
935NDA/MAL/HDP/1501REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDCURAQUIN SYRUPQUININE HYDROCHLORIDE100MG/5MLREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA KENYAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE01/07/2009
936NDA/MAL/HDP/1503MEDICAL UNION PHARMACUITICALSKARURI PHARMACEUTICALS LTD.SEDIPROCT CREAMHYDROCORTISONE+CINCHOCAINE0.5%W/W + 0.5%W/WMEDICAL UNION PHARMA .CO-ABU-SULTAN ISMAILIA EGYPTEGYPTTOPICAL EXTERNAL OTHER CREAMS1.0X20.0 G TUBE01/07/2003
937NDA/MAL/HDP/1505GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDSERETIDE EVOHALERSALMETEROL/ FLUTICASONE PROPIONATE25/50 MCGGLAXO WELLCOME PRODUCTION-ZONE INDUSTRIELLE NO.2
23 RUE LAVOISER 27000 EVREUX
FRANCELUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER1.0X1.0 CANNISTER CARTON01/07/2007
938NDA/MAL/HDP/1506WOCKHARDT LTDSTAR PHARMACEUTICALS LTDWEPOX 2000RECOMBINANT HUMAN ERYTHROPOIETIN2000 IUWOCKHARDT LIMITED --WOCKHARDT BIOTECH PARK, H14/2, M.I.D.C, WALUJ, AURANGABAD 431136 MAHARASHTRA INDIA INDIAPARENTERAL ORDINARY PRE-FILLED SYRINGES1.0X0.5 ML PRE- FILLED SYRINGE01/07/2011
939NDA/MAL/HDP/1508IMMUCORSUPER MEDIC LTDWOMNILALBENDAZOLE200MG/5MLDAWA-PLOT 7879, BABA DOGO ROAD RUARAKA, NAIROBI, KENYA KENYAORAL LIQUID ORDINARY SUSPENSIONS1.0X10.0 ML BOTTLE01/07/2009
940NDA/MAL/HDP/1509BETA HEALTHCARE UGANDA LIMITEDBETA HEALTHCARE UGANDA LIMITEDFEVEREXPARACETAMOL500MGBETA HEALTHCARE INTERNATIONAL LTD-PLOT LR 209/6554 MOGADISHU ROAD, OFF LUNGA LUNGA ROAD, INDUSTRIAL AREA NAIROBI, 00100, KENYAORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER01/07/2007
941NDA/MAL/HDP/1510JOHNSON &JOHNSON (PTY) LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDLISTERINE ANTISEPTICTHYMOL + ALCOHOL 95%12.78MG/20ML + 5.60ML/MLJOHNSON&JOHNSON PTY LTD.-EDMS BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICA SOUTH AFRICAORAL LIQUID ORDINARY LIQUIDS1.0X500.0 ML BOTTLE,1.0X250.0 ML BOTTLE01/07/2001
942NDA/MAL/HDP/1513ANKUR DRUGS AND PHARMA LTDJOINT MEDICAL STORE (UPMB - UCMB)VEXACEFCEFTRIAXONE1GANKUR DRUGS AND PHARMA LTD-WHITE TO OFF WHITE VILLAGE – MANAKPUR, PO – LODHIMAJRA, NELAGARH DIST. INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0 G VIAL01/07/2014
943NDA/MAL/HDP/1514JOHNSON&JOHNSON PTY LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDVERMOXMEBENDAZOLE100MGSPECPHARM HOLDINGS- 15TH ROAD HALFWAY HOUSESOUTH AFRICAORAL SOLID ORDINARY CHEWABLE TABLETS1.0X6.0 TABLET BLISTER01/07/1997
944NDA/MAL/HDP/1515CIPLA LTDQUALITY CHEMICALS LTD - HUMANCIPLACEF 1000CEFTRIAXONE1000MGCIPLA LTD C/O OKASA-OKASA PHARMA PVT LTD L-2 ADDITIONAL MIDC SATARA 415004INDIAPARENTERAL ORDINARY DRY VIALS1.0X15.0 ML VIAL + 1X1 WFI AMPOULE01/07/2007
945NDA/MAL/HDP/1516WIN-MEDICARE LTDSURGIPHARM (U) LIMITEDURGENDOL PTRAMADOL/ PARACETAMOL37.5MG/ 325MGWIN MEDICARE PVT LIMITED-MEERUT, MUZAFFARNAGER ROAD, MODIPURAM – 250110, UTTAR
PRADESH - INDIA
INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2011
946NDA/MAL/HDP/1517NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDVEST MENTAMU BALMCOMPOUND METHYLSALICYLATEMULTI INGREDIENTNEM LABORATORIES PVT LTD-133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAIINDIATOPICAL EXTERNAL OINTMENTS1.0X15.0 G TUBE01/07/1998
947NDA/MAL/HDP/1519CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDFORMONIDE 400BUDESONIDE + FORMOTEROL FUMARATE120 METERED DOSES (400MCG/6MCG)CADILA HEALTHCARE LTD---SARKHEJ-PLOT 417,419,420, SARKHEJ-BAVLA NH NO.8A,VILLAGE: MORAIYA TAL: SANAND DISTRICT AHMEDABAD 382210 INDIALUNG ADMINISTRATION METERED-DOSE INHALER1.0X1.0 CANNISTER CARTON01/07/2007
948NDA/MAL/HDP/1522GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDPENAMOXAMOXYCILLIN250MGMEDREICH STERILAB LTD-12TH MILE, OLD MADRAS ROAD, VIRGONAGOR, BANGALORE 560049, INDIA INDIAORAL SOLID ORDINARY CAPSULES10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER01/07/1997
949NDA/MAL/HDP/1523RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDAMPIRENAMPICILLIN125MG/5MLRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA UGANDAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE01/07/2007
950NDA/MAL/HDP/1524RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDAMOXIRENAMOXICILLIN TRIHYDRATE125 MG / 5 MLRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA UGANDAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE01/07/2008
951NDA/MAL/HDP/1525CIPLA LIMITED.QUALITY CHEMICALS LTD - HUMANBENDEXALBENDAZOLE20MG/5MLCIPLA LTD ,,-PLOT NO. 9,10,15 INDORE SPECIAL ECONOMIC ZONE PHASE II PITHAMPUR DISTRICT DHAR MADHYA PRADESH PIN. 454775 INDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X10.0 ML BOTTLE01/07/2007
952NDA/MAL/HDP/1526FERRER INTERNACIONAL S.ALABOREX UGANDA LIMITEDGAMALATE B6MAGNESIUM GLUTAMATE HYDROBROMIDE + AMINOBUTYRIC ACID + AMINO HYDROXYBUTYRIC ACID + VITAMIN B675MG + 75MG + 37MG + 37MGFERRER INTERNACIONAL S.A --FOR LABORATORIOS NOVAG S.A GRAN VIA CARLOS III 94 08028 BARCELONASPAINORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER07/01/15
953NDA/MAL/HDP/1527MICRO LABS LTDLABOREX UGANDA LIMITEDBACTOCLAVAMOXICILLIN + CLAVULANATE POTASSIUM200MG + 28.5MG/ 5MLMICRO LABS LIMITED.-PLOT 16, VEERASANDRA IND. AREA,ANEKAL TALUK, BANGALORE INDIA INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X1.0X100.0 ML BOTTLE01/07/2012
954NDA/MAL/HDP/1528MICRO LABS LTDLABOREX UGANDA LIMITEDBACTOCLAV-625AMOXYCILLIN + CLAVULANATE POTASSIUM500 MG + 125 MGMICRO LABS LIMITED -PLOT 16 VEERASANDRA IND. AREA,ANEKAL TALUK,BANGALORE INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X1.0X6.0 TABLET BLISTER,1.0X2.0X10.0 TABLET BLISTER01/07/2007
955NDA/MAL/HDP/1529BAYER PHARMA AGSURGIPHARM (U) LIMITEDPROVIRONMESTEROLONE25MGBAYER WEIMAR GMBH & CO. KG-DOBEREINERSTRASSE 20 D-99427 WEIMAR, GERMANY GERMANYORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER01/07/1997
956NDA/MAL/HDP/1531CIPLA LTDQUALITY CHEMICALS LTD - HUMANNOVATAXCEFOTAXIME1GMMEDISPRAY LABORATORIES PVT LTD --L-1/1, L-1/2/2, ADDITIONAL MIDC SATARA 415004 INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0 G VIAL01/07/2009
957NDA/MAL/HDP/1533OTSUKA PHARMACEUTICAL INDIA PRIVATE LIMITEDREDDYS PHARMA LIMITED5DGLUCOSE50G/LOTSUKA PHARMACEUTICAL INDIA PRIVATE LTD-VILLAGE – VASANA – CHACHARWADIP, TAL: SANAND, AHMADABAD INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X500.0 ML BOTTLE,1.0X250.0 ML BOTTLE07/01/07
958NDA/MAL/HDP/1535ABACUS PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDFORTIWIN-4FORTIFIED PROCAINE PENICILLIN SODIUM4 M.UREYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG PROVINCE P.R. 256100 CHINAPARENTERAL ORDINARY DRY VIALS1.0X50.0X4.0 MU VIAL01/07/2011
959NDA/MAL/HDP/1537ELYS CHEMICAL INDUSTRIES LTDVELVET PHARMA LIMITEDELYZOLEALBENDAZOLE200MGELYS CHEMICAL INDUSTRIES LIMITED-ROAD B’, OFF ENTERPRISE ROAD
PLOT NO. 209/8927 INDUSTRIAL AREA
KENYAORAL SOLID ORDINARY TABLETS1.0X20.0X2.0 TABLET BLISTER01/07/2005
960NDA/MAL/HDP/1538ELYS CHEMICAL INDUSTRIES LTDVELVET PHARMA LIMITEDELYZOLE SUSPENSIONALBENDAZOLE200MGELYS CHEMICAL INDUSTRIES LIMITED-ROAD B’, OFF ENTERPRISE ROAD
PLOT NO. 209/8927 INDUSTRIAL AREA
KENYAORAL LIQUID ORDINARY SUSPENSIONS1.0X10.0 ML BOTTLE01/07/2003
961NDA/MAL/HDP/1539KWALITY AFRO ASIA LIMITEDKWALITY AFRO ASIA LIMITEDK-TRIMSULFAMETHOXAZOLE + TRIMETHOPRIM200MG + 40MGKWALITY AFRO-ASIA LTD-PLOT 165 KAWEMPE BOMBO ROADUGANDAORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE01/07/2010
962NDA/MAL/HDP/1543MEDIPHARM INDUSTRIES LTDMEDIPHARM INDUSTRIES (E.A) LTDPROMAZINE ELIXIRPROMETHAZINE HYDROCHLORIDE5MG/MLMEDIPHARM INDUSTRIES( EA) LTD-PLOT 65 KAKAJJO ROAD BWEYOGERERE P.O.BOX 6218,KAMPALA,UGANDA UGANDAORAL LIQUID ORDINARY LIQUIDS1.0X60.0 ML BOTTLE01/07/1997
963NDA/MAL/HDP/1544AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDPROMETHAZINE HYDROCHLORIDE B.PPROMETHAZINE HCL25MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER01/07/2004
964NDA/MAL/HDP/1546UNICHEM LABORATORIES LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDLANPROLANSOPRAZOLE30MGUNICHEM LABORATORIES LTD--PLOT 17 & 18, PILERNE IND. ESTATE, PILERNE, BARDEZ GOA-403511 INDIAORAL SOLID ORDINARY CAPSULES1.0X5.0X2.0X10.0 CAPSULE BLISTER01/07/1999
965NDA/MAL/HDP/1547MYLAN LABS LTDNORVIK ENTERPRISES LIMITEDLUSIA-FNORGESTREL/ ETHINYL ESTRADIOL + FERROUS FUMARATE0.3MG/ 0.03MG + 75MGMYLAN LABORATORIES LIMITED.--PLOT NO. 1606-1609, SARIGAM INDUSTRIAL AREA, GIDC, SARIGAM, TAL-UMERGAM, DIST VALSAD, 396155, GUJARAT, INDIA. MYLAN LABORATORIES LIMITED..-PLOT NO.20 & 21, PHARMEZ, SARKHEJ-BAVLA NATIONAL HIGHWAY NO. 08A, NEAR VILLAGE MATODA, TAL-SANAND, AHMEDABAD, GUJARAT, INDIA 382213 INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X28.0 TABLET BLISTER01/07/2007
966NDA/MAL/HDP/1550GALENTIC PHARMA( INDIA)PVT LTDNORVIK ENTERPRISES LIMITEDRUBIGELMULTI-INGREDIENTMULTI-INGREDIENTGALENTIC PHARMA PVT. LIMITED -R-673, TTC MIDC, RUBALE, THANE BELAPUR NAVI MUMBAI 400 701
INDIA
INDIAORAL TOPICAL GELS AND SOLS1.0X30.0 G TUBE01/07/2007
967NDA/MAL/HDP/1551EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDCALOSHELL-500CALCIUM CARBONATE + VITAMIN D31250MG + 250IUEMCURE PHARMACEUTICALS LTD-LANE NO.3 PHASE II SIDCO INDUSTRIAL COMPLEX BARI BRAHMANA JAMMU (J&K) 18113INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2004
968NDA/MAL/HDP/1553EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDVIFEXSALBUTAMOL + BROMHEXINE + GUAIFENESIN1MG/5ML+2MG/5ML+50MG/5MLEMCURE PHARMACEUTICALS LTD-LANE NO.3 PHASE II SIDCO INDUSTRIAL COMPLEX BARI BRAHMANA JAMMU (J&K) 18113INDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE01/07/2004
969NDA/MAL/HDP/1554KOTRA PHARMA (M) SDN BHDABACUS PHARMA (AFRICA) LIMITEDAXCEL CETIRIZINECETIRIZINE DIHYDROCHLORIDE5MG/5MLKOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA MALAYSIAORAL LIQUID ORDINARY SYRUPS1.0X60.0 ML BOTTLE01/07/2010
970NDA/MAL/HDP/1555GALENTIC PHARMA( INDIA)PVT LTDNORVIK ENTERPRISES LIMITEDGALSCRUBCHLORHEXIDINE4%W/WGALENTIC PHARMA PVT. LIMITED -R-673, TTC MIDC, RUBALE, THANE BELAPUR NAVI MUMBAI 400 701
INDIA
INDIATOPICAL EXTERNAL LIQUIDS1.0X500.0 ML BOTTLE01/07/2008
971NDA/MAL/HDP/1556VIRBAC RSA (PTY) LTDMETRO PHARMACEUTICALS LIMITEDDOMI UPONDASENTRON2MG/MLLINCOLN PARENTERAL LTD-11, TRIMUL ESTATE, NEAR KHATRAJ CHOLADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT INDIAPARENTERAL ORDINARY AMPOULES1.0X10.0X2.0 ML AMPOULE01/07/2014
972NDA/MAL/HDP/1557GLAXOSMITHKLINEUNITED HEALTHCARE DISTRIBUTORS LTDSYNFLORIX VACCINEPNEUMOCOCCAL POLYSACCHARIDE SEROTYPES (1,5,6B,7F,9V,14,23F) + (4,18C,19F) + PROTEIN D+TETANUS TOXOID+DIPTHERIA TOXOID CARRIER PROTEINS AND ALUMINIUM PHOSPHATE1MCG+3MCG+13MCG+8MCG+5MCG+0.5MGGLAXOSMITHKLINE BOILOGICALS-S.A RUE DE I'INSTITUT 89 B-1330 RIXENSARTBELGIUMPARENTERAL ORDINARY PRE-FILLED SYRINGES1.0X0.5 ML PRE- FILLED SYRINGE (1 DOSE),1.0X100.0X0.5 ML VIAL (1 DOSE)07/01/10
973NDA/MAL/HDP/1558PFIZER LABORATORIES (PTY) LTDLABOREX UGANDA LIMITEDGABBRORALAMINOSIDINE SULPHATE250MGPHARMACIA AND UPJOHN S.P.A-RIJKSWEG 12, B-2870 PUURS BELGIUMORAL SOLID ORDINARY TABLETS1.0X12.0 TABLET STRIP01/07/1998
974NDA/MAL/HDP/1559LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDDOLOMOLPARACETAMOL500MGLINCOLN PHARMACEUTICALS LTD-10, 11, 13, TRIMUL ESTATE KHATRAJ, NEAR KHATRAJ, CHOKADI , KHATRAJ-382721, GHANDINAGAR GUJARAT, INDIA
INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X1.0X10.0 TABLET BLISTER01/07/2003
975NDA/MAL/HDP/1563GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDAMOXILAMOXYCILLIN125MG/5MLGLAXO WELLCOME PRODUCTION.-ZONE INDUSTRIELLE DE LA PEYENNIERE 53100 MAYENNE, FRANCE FRANCEORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE07/01/97
976NDA/MAL/HDP/1566AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDVITAVITMULTI-INGREDIENTMULTI-INGREDIENTAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY OTHER COATED TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER01/07/2009
977NDA/MAL/HDP/1568: ALKEM LABORATORIES LIMITED?ABACUS PHARMA (AFRICA) LIMITEDCLAVAMAMOXICILLIN AND CLAVULANATE POTASSIUM156.25MGALKEM LABORATORIES LTD-PLOT 167/1 VILLABE DAHBEL AMALIYA DAMAN 396210INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE01/07/2008
978NDA/MAL/HDP/1569ABBVIE (PTY) LTDMEDICAL ACCESS (UGANDA) LIMITEDKALETRALOPINAVIR+RITONAVIR80MG + 20MGAESICA PHARMACEUTICALS SRL-QUEENBOROUGH KENT ME 11 5EL, UNITED KINGDOM UNITED KINGDOMORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X5.0X1.0X60.0 ML BOTTLE07/01/07
979NDA/MAL/HDP/1570KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAM AMOXYAMOXYCILLIN125MG/5MLKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALAUGANDAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE01/07/1997
980NDA/MAL/HDP/1571BHARAT SERUMS AND VACCINES LTDABACUS PHARMA (AFRICA) LIMITEDRHOCLONEMONOCLONAL ANTI-D IMMUNOGLOBULIN300MCGBHARAT SERUMS AND VACCINES LIMITED,-PLOT NO. K-27, ADDITIONAL MIDC,
AMBERNATH (EAST), INDIA
INDIAPARENTERAL ORDINARY DRY VIALS1.0X2.0 ML VIAL (1 DOSE VIAL)01/07/2013
981NDA/MAL/HDP/1574INTAS, PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDAMTAS-5AMLODIPINE5MGINTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIA INDIAORAL SOLID ORDINARY TABLETS2.0X2.0X7.0 TABLET BLISTER,10.0X10.0 TABLET BLISTER01/07/2003
982NDA/MAL/HDP/1575ASTRAZENECAMACNAUGHTON LIMITEDZESTRILLISINOPRIL20MGASTRAZENECA PHARMACEUTICALS LP -HUANGSHAN ROAD, WUXI 214028, JIANGSU, CHINA. ASTRAZENECA MACCLESFIELD-CHESHIRE UNITED KINGDOMORAL SOLID ORDINARY TABLETS1.0X2.0X14.0 TABLET BLISTER01/07/1997
983NDA/MAL/HDP/1576ASTRAZENECAMACNAUGHTON LIMITEDZESTRILLISINOPRIL10MGASTRAZENECA PHARMACEUTICALS LP -HUANGSHAN ROAD, WUXI 214028, JIANGSU, CHINA. ASTRAZENECA MACCLESFIELD-UNITED KINGDOM UNITED KINGDOMORAL SOLID ORDINARY TABLETS1.0X1.0X14.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER01/07/1997
984NDA/MAL/HDP/1577SEARLE PAKISTAN LTDHEALTHCARE LTD.SPIROMIDESPIRONOLACTONE + FRUSEMIDE50MG+20MGTHE SEARLE COMPANY-32-KM MULTAN ROAD, LAHORE INDIAORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET STRIP01/07/2005
985NDA/MAL/HDP/1579PT SANBE FARMAMEDVIN PHARMA LIMITEDPLASMINEXTRANEXAMIC ACID100MG/MLPT SANBE FARMA JI INDUSTRI-NO.8 KOMPLEKS INDUSTRI CIMAREME PADALARANG BANDUNGINDONESIAPARENTERAL ORDINARY AMPOULES1.0X10.0X5.0 ML AMPOULE01/07/2011
986NDA/MAL/HDP/1581MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDPANTOTABPANTOPRAZOLE40MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2006
987NDA/MAL/HDP/1582LINCON PHARMCUETICALS LIMITEDMETRO PHARMACEUTICALS LIMITEDCEEPRO-500CIPROFLOXACIN500MGLINCOLN PHARMACEUTICALS LTD--TRIMUL ESTATE AFER VODSAR VILLAGE KHATJAT 382 721 GUJARAT VADSAR P.O.J TALUKA KALOH DIST GANDHINAGAR INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2005
988NDA/MAL/HDP/1584UNI MEDICO LABSHREEJI PHARMACEUTICALS LIMITEDUCLOXCLOXACILLIN SODIUM500MGUNI MEDICOLABS.- 21-22 PHARMACITY SELAQUI DEHRADUN 248197INDIAPARENTERAL ORDINARY DRY VIALS1.0X500.0 MG VIAL01/07/2015
989NDA/MAL/HDP/1585WIN-MEDICARE PVT LTDSURGIPHARM (U) LIMITEDUDIHEP FORTEURSODEOXYCHOLIC ACID300MGWIN-MEDICARE PRIVATE LIMITED-MEERUT-MUZAFFARNAGAR ROAD, MODIPURAM - 250110 UTTAR PRADESH INDIAORAL SOLID ORDINARY TABLETS1.0X5.0X10.0 TABLET BLISTER01/07/2010
990NDA/MAL/HDP/1588TORRENT PHARAMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.TOZAAR-HLOSARTAN POTASSIUM + HYDROCHLOROTHIAZIDE50MG + 12.5MGTORRENT PHARMACEUTICALS LIMITED -AHMEDABAD-MEHSANA HIGHWAY, TAL. KADI, DIST. MEHSANA, INDRAD 382 721, GUJARAT INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET STRIP,1.0X4.0X7.0 TABLET BLISTER01/07/2005
991NDA/MAL/HDP/1589CENTAUR PHARMACEUTICALS PVT LTDGITTOES PHARMACEUTICALS LIMITEDCENTACID SUSPENSIONMAGNESIUM HYDROXIDE + ALUMINIUM HYDROXIDE+SIMETHICONE40MG+200MG+250MG/5MLCENTAUR PHARMACEUTICALS PVT LTD-PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE,1.0X170.0 ML BOTTLE01/07/1997
992NDA/MAL/HDP/1591CENTAUR PHARMACEUTICALS LTDGITTOES PHARMACEUTICALS LIMITEDCENTIPAR ELIXIRPIPERAZINE CITRATE750ML/5MLCENTAUR PHARMACEUTICALS PVT LTD-PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIAINDIAORAL LIQUID ORDINARY LIQUIDS1.0X30.0 ML BOTTLE01/07/1997
993NDA/MAL/HDP/1598AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOCIM 400CIMETIDINE400MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2005
994NDA/MAL/HDP/1605RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDASPIRIN TABLETSACETYL SALICYLIC ACID300MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA UGANDAORAL SOLID ORDINARY TABLETS1.0X500.0 TABLET CONTAINER01/07/2001
995NDA/MAL/HDP/1614ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDASTAGRA-50SILDENAFIL50MGASTRA LIFE CARE (INDIA) PVT LIMITED-57/P RAJODA
382220 BAVIA
AHMEDABAD INDIA
INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X1.0X4.0 TABLET BLISTER01/07/2011
996NDA/MAL/HDP/1615AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDAPCALIS SXTADALAFIL20MGAJANTA PHARMA LIMITED PAITHAN-MANUFACTURING UNIT B-4/5/6 MIDC PAITHAN DISTRICT AURANGABAD 431 148 MAHARASTRA STATE INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X2.0 TABLET BLISTER01/07/2005
997NDA/MAL/HDP/1616AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDCEZINCETIRIZINE5MG/5MLAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE,1.0X30.0 ML BOTTLE,1.0X60.0 ML BOTTLE01/07/2011
998NDA/MAL/HDP/1620IRAN MEDICAL GROUP COMPANYUNEED GLOBAL GROUP LIMITEDLORAXONECEFTRIAXONE1000MGEXIR PHARMACEUTICAL FACTORY-2ND KM, BORUJERD, RU IRANPARENTERAL ORDINARY DRY VIALS1.0X1000.0 MG VIAL01/07/2008
999NDA/MAL/HDP/1627GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDCANDID-V GELCLOTRIMAZOLE2%W/WGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D INDIAVAGINAL GELS AND SOLS1.0X30.0 G TUBE01/07/2004
1000NDA/MAL/HDP/1629INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDCARVETAS 12.5CARVEDILOL12.5MGINTAS PHARMACEUTICALS LTD-SELAQUI DEHRADUN 248197INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2011
1001NDA/MAL/HDP/1631AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDNEVIRAPINE ORAL SUSPENSIONNEVIRAPINE50MG/5MLAUROBINDO PHARMA LTD-UNIT III SURVEY NO 313& 314, BACHUPALLY (V),QUTHUBULLAPUR (M), RANGA REDDY (DIST) TELANGANA STATE,INDIA INDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X240.0 ML BOTTLE,1.0X100.0 ML BOTTLE01/07/2007
1002NDA/MAL/HDP/1632: ALKEM LABORATORIES LIMITED?ABACUS PHARMA (AFRICA) LIMITEDCLAVAM 1.2GAMOXICILLIN SODIUM + CLAVULANATE POTASSIUM1000MG +200MGALKEMS LABORATORIES LIMITED-PLOT 167/1 MAHATMA GHANDHI, UDYOG NAGAR, DABHEL, AMALIYA DAMAN- 396 210
UTTARANCHAL, INDIA.
INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0 VIAL CARTON01/07/2005
1003NDA/MAL/HDP/1635CADILA PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.ORITAXIM 1000MG INJECTIONCEFOTAXIME SODIUM1GMCADILA PHARMACEUTICALS LIMITED-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA INDIAPARENTERAL ORDINARY VIALS1.0X1.0 G VIAL01/07/1997
1004NDA/MAL/HDP/1636NORVATIS PHARMA AG- SWITZERLANDLABOREX UGANDA LIMITEDVIGAMOXMOXIFLOXACIN5MG/MLS.A.ALCON COUVREUR N.V-RIJKSWEG 14, B-2870 PUURS BELGIUM BELGIUMOPHTHALMIC DROPS1.0X5.0 ML BOTTLE07/01/13
1005NDA/MAL/HDP/1638AMOUN PHARMACEUTICAL COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDFLADAZOLESECNIDAZOLE500MGAMOUN PHARMACEUTICALS CO. S.A.E-1ST INDUSTRIAL ZONE, EL-OBOUR CITY, EGYPT. EGYPTORAL SOLID ORDINARY TABLETS1.0X4.0 TABLET BLISTER01/07/2005
1006NDA/MAL/HDP/1639GLAXO SMITHLINE LIMITEDUNITED HEALTHCARE DISTRIBUTORS LTDPANADOL EXTRAPARACETAMOL + CAFFEINE500MG + 65MGGLAXOSMITHKLINE LIMITED - -78392-00507, VIWANDANI LIKONI ROAD NAIROBI KENYA KENYAORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CARTON07/01/03
1007NDA/MAL/HDP/1641UNICHEM LABORATORIES LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDUNIENZYME C MPSNICOTINAMIDE+SIMETHICONE+PAPAIN+FUNGAL DIASTASE+CHARCOAL25MG+50MG+30MG+20MG+75MGUNICHEM LABORATORIES LTD---C31 & 32 INDUSTRIAL AREAINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET STRIP01/07/2004
1008NDA/MAL/HDP/1642UMEDICA LABORATORIES PVT LTDGITTOES PHARMACEUTICALS LIMITEDEUCHLOR-1000CHLORAMPHENICOL SODIUM SUCCINNATE B.P1GUMEDICA LABORATORIES PVT LTD-PLOT NO. 221, 2ND PHASE, GIDC, VAPI 396195, GUJARAT. INDIA. INDIAPARENTERAL ORDINARY VIALS1.0X1.0 G VIAL01/07/2004
1009NDA/MAL/HDP/1645ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDASTAZOLEMEBENDAZOLE100MGASTRA LIFE CARE (INDIA) PVT.LTD-PLOT 57/P, RAJODA-382220, BAVLA AHMEDABAD, INDIA INDIAORAL SOLID ORDINARY CHEWABLE TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER01/07/1997
1010NDA/MAL/HDP/1646BETA HEALTHCARE INTERNATIONAL LTDBETA HEALTHCARE UGANDA LIMITEDBETROZOLE TABLETSMETRONIDAZOLE+DILOXANIDE200MG+250MGBETA HEALTHCARE INTERNATIONAL LTD - -PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYA KENYAORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET BLISTER01/07/2002
1011NDA/MAL/HDP/1650NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDTEGRETOL CR 200CARBAMAZEPINE200MGNOVARTIS FARMA S.P.A.-VIA PROVINCIALE SCHITO 131, 80058 TORRE ANNUNZIATA, ITALY ITALYORAL SOLID RETARD TABLETS1.0X5.0X10.0 TABLET BLISTER01/07/2006
1012NDA/MAL/HDP/1652TORRENT PHARAMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.VALPARIN CHRONO 300SODIUM VALPROATE300MGTORRENT PHARMACEUTICAL LTD-AHMEDABAD-MEHSANA HIGHWAY,TALUKA-KADI,DIST.MEHSANA,INDRAD-382721 INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET STRIP01/07/2009
1013NDA/MAL/HDP/1656ANHIUMAISHA MEDICAL SUPPLIES LIMITEDAZIGYL-500AZITHROMYCIN500MGMEDICO REMEDIES PVT LIMITED-8 & 9 DEWAN & SONS, UDYOG NAGAR PALGAR, DISTRICT THANE MAHARASHTRA, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER,1.0X3.0 TABLET BLISTER01/07/2015
1014NDA/MAL/HDP/1659FREDUN PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDPROFRED 40 TABLETSPROPRANOLOL40MGFREDUN PHARMACEUTICALS LTD MANOJ-MANOJ INDUSTRIAL PREMISES G.D AMBEKAR MARG WEDALA MUMBAI 400031INDIAORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER01/07/1999
1015NDA/MAL/HDP/1660AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOCIM-200CIMEDITINE200MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET STRIP01/07/2005
1016NDA/MAL/HDP/1661ABBVIE (PTY) LTDMEDICAL ACCESS (UGANDA) LIMITEDALUVIA 100/25LOPINAVIR/ RITONAVIR100MG/25MGABBVIE DEUTSCHLAND GMBH & CO. KG.-KNOLLSTASSE 50, D-67061, LUDWIGSHAFEN, GERMANY. GERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X60.0 TABLET CONTAINER01/07/2007
1017NDA/MAL/HDP/1663MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDALCID-PINKALUMINIUM HYDROXIDE/MAGNESIUM TRISILICATE400MG+400MG/50MLTORQUE PHARMACEUTICALS PVT LTD-ISAAPUR P.O DAPPAR 140056 INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X400.0 ML BOTTLE,1.0X160.0 ML BOTTLE01/07/2003
1018NDA/MAL/HDP/1665AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOXIN CAPSULESAMOXICILLIN TRIHYDRATE250MGMILAN LABORATORIES (INDIA ) PVT LTD-PLOT NO 63/67/87 J.C.I.E LTD KAMOTHE PANVER, NAVI MUMBAI,INDIA INDIAORAL SOLID ORDINARY CAPSULES1.0X100.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER01/07/1998
1019NDA/MAL/HDP/1666SANOFI AVENTISLABOREX UGANDA LIMITEDAMARYL 1GLIMEPIRIDE1MGSANOFI AVENTIS-2 BOND STREET MIDRAND 1685 SOUTH AFRICASOUTH AFRICAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER07/01/05
1020NDA/MAL/HDP/1669SANOFI AVENTISLABOREX UGANDA LIMITEDAMARYL 2GLIMEPIRIDE2MGAVENTIS PHARMA-AVENTIS PHARMA, 315 WALTLOO ROAD, SILVERTON 0127 PRETORIA SOUTH AFRICAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER07/01/05
1021NDA/MAL/HDP/1670SANOFI AVENTISLABOREX UGANDA LIMITEDAMARYL 4GLIMIPIRIDE4MGAVENTIS PHARMA-AVENTIS PHARMA, 315 WALTLOO ROAD, SILVERTON 0127 PRETORIA SOUTH AFRICAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER07/01/05
1022NDA/MAL/HDP/1673GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDAMOXILAMOXYCILLIN250MGGLAXO WELLCOME PRODUCTION -Z.I DE LA PEYENNIERE 53100 MAYENNE FRANCEFRANCEORAL SOLID ORDINARY CAPSULES10.0X10.0 CAPSULE BLISTER07/01/97
1023NDA/MAL/HDP/1675MERCK SHARP & DOHME BVPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDGARDASILQUADRIVALENT HUMAN PAPILLOMAVIRUS RECOMBINANT VACCINE (TYPES 6, 11, 16, 18)(20MCG+40MCG+40MCG+20MCG)/0.5MLMERK & CO. INC-SUMNEYTOWN PIKE, P.O BOX 4, WEST POINT, PENNSYLVANIA, U.S. 19486, USA UNITED STATESPARENTERAL ORDINARY PRE-FILLED SYRINGES1.0X0.5 ML PRE- FILLED SYRINGE (1 DOSE),1.0X10.0X0.5 ML VIAL (1 DOSE)01/07/2007
1024NDA/MAL/HDP/1676KOPRAN LIMITEDTATA UGANDA LIMITEDCLOXIN-250CLOXACILLIN250MGKOPRAN LTD-VILLAGE SAVROLI TAL KHARAPUR DIST RAIGAD 410 202INDIAORAL SOLID ORDINARY CAPSULES1.0X100.0 CAPSULE CONTAINER,1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER01/07/1997
1025NDA/MAL/HDP/1677MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDZIDOVUDINEZIDOVUDINE300MGMACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X60.0 TABLET BOTTLE01/07/2011
1026NDA/MAL/HDP/1679LEBEN LABORATORIES PVT. LTDANDYCO PHARMACY (UGANDA) LTDCIPROLEBCIPROFLOXACIN500MGLEBEN LABORATORIES PVT. LTD.-PLOT NO. L-4, PHASE –III, M.I.D.C, AKOLA, 444104, MAHARASHTRA, INDIA. INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2007
1027NDA/MAL/HDP/1680NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDH-CORTHYDROCORTISONE0.1%W/WNEM LABORATORIES PVT LTD-133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAIINDIATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE01/07/1997
1028NDA/MAL/HDP/1681CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDLOSACAR 25LOSARTAN POTASSIUM25MGCADILA HEALTH CARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X7.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER01/07/2003
1029NDA/MAL/HDP/1682VIRBAC RSA (PTY) LTDMETRO PHARMACEUTICALS LIMITEDTOFLOX-200OFLOXACIN200MGLINCOLN PHARMACEUTICAL LIMITED-TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER,1.0X10.0X1.0X10.0 TABLET BLISTER01/07/2005
1030NDA/MAL/HDP/1683Y.S.P INDUSTRIES (M) SDN BHDROYAL PHARMA 2011 LIMITEDVOREN PLUSDICLOFENAC10MG/ML Y.S.P INDUSTRIES (M) SDN BDH - LOT 3,5 & 7 P/7 SECTION 13 KAWASAN PERINDUSTRIAN BANDAR BARU BANGI 43000 KAJANG SELANGOR DARUL EHSAN MALAYSIATOPICAL EXTERNAL GELS AND SOLS1.0X20.0 G TUBE,1.0X45.0 G TUBE07/01/10
1031NDA/MAL/HDP/1684LINCOLN PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDIBUN-200IBUPROFEN200MGLINCOLN PHARMACEUTICALS LTD-10, 11, 13, TRIMUL ESTATE KHATRAJ, NEAR KHATRAJ, CHOKADI , KHATRAJ-382721, GHANDINAGAR GUJARAT, INDIA
INDIAORAL SOLID ORDINARY COATED TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER01/07/2005
1032NDA/MAL/HDP/1686LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDQUININE SULPHATEQUININE SULPHATE300MGLINCOLN PHARMACEUTICALS LTD-10, 11, 13, TRIMUL ESTATE KHATRAJ, NEAR KHATRAJ, CHOKADI , KHATRAJ-382721, GHANDINAGAR GUJARAT, INDIA
INDIAORAL SOLID ORDINARY COATED TABLETS1.0X1000.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER01/07/2005
1033NDA/MAL/HDP/1687LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDALLDOXDOXYCYLINE100MGLINCOLN PHARMACEUTICALS LIMITED-10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER01/07/2005
1034NDA/MAL/HDP/1690PHARMA INTERNATIONAL COOMAB UGANDA LIMITEDFINALLERGCETIRIZINE DIHYDROCHLORIDE1MG/MLPHARMA INTERNATIONAL COMPANY-MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDAN JORDANORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE01/07/2004
1035NDA/MAL/HDP/1691WIDE SPECTRUM ENTERPRISES (U) LIMITEDWIDE SPECTRUM ENTERPRISES (U) LIMITEDZITHRORIVAZITHROMYCIN500MGRIVA PHARMA FREE ZONE-NASR CITY CAIRO EGYPTEGYPTORAL SOLID ORDINARY CAPSULES1.0X3.0 CAPSULE BLISTER01/07/2011
1036NDA/MAL/HDP/1692PHARMA INTERNATIONAL COOMAB UGANDA LIMITEDCEFODOX 50MG/5ML SUSPENSIONCEFPODOXIME PROXETIL50MG/5MLPHARMA INTERNATIONAL CO.,-AL-QASTAL AREA, AIRPORT ROAD, 11941, AMMAN JORDANORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X50.0 ML BOTTLE01/07/2007
1037NDA/MAL/HDP/1693PHARMA INTERNATIONAL COMPANYOMAB UGANDA LIMITEDOPTIMAL (0.05%) CREAMTRETINOIN USP0.5MG/1GPHARMA INTERNATIONAL COMPANY .-MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDANTOPICAL EXTERNAL CREAMS1.0X1.0X30.0 G TUBE01/07/2005
1038NDA/MAL/HDP/1694GLAXO WELLCOME(KENYA),LTDUNITED HEALTHCARE DISTRIBUTORS LTDBETNOVATE CREAMBETAMETHASONE VALERATE0.1%W/WGLAXOSMITHKLINE HARMIRE -GLAXOSMITHKLINE HARMIRE ROAD BARNARD CASTLE DURHAMUNITED KINGDOMTOPICAL EXTERNAL CREAMS1.0X30.0 G TUBE,1.0X15.0 G TUBE01/07/1998
1039NDA/MAL/HDP/1697PHARMA INTERNATIONAL COOMAB UGANDA LIMITEDFINALLERGCETIRIZINE DIHYDROCHLORIDE10MGPHARMA INTERNATIONAL COMPANY-MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDAN JORDANORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER01/07/2005
1040NDA/MAL/HDP/1698CIPLA LTDQUALITY CHEMICALS LTD - HUMANAZEE-500AZITHROMYCIN500MGCIPLA LTD.-VERNA IND. ESTATE GOA 403 722 INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X1.0X3.0 TABLET BLISTER01/07/2009
1041NDA/MAL/HDP/1701KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDFORMINMETFORMIN HYDROCHLORIDE500MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALAUGANDAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2014
1042NDA/MAL/HDP/1702PHARMA INTERNATIONAL COMPANYOMAB UGANDA LIMITEDDELORCLOBETASOL PROPIONATE0.05%W/WPHARMA INTERNATIONAL COMPANY-MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDAN JORDANTOPICAL EXTERNAL OINTMENTS1.0X25.0 G TUBE01/07/2005
1043NDA/MAL/HDP/1704DAFRA PHARMA LTDLABOREX UGANDA LIMITEDDAFRACLAVAMOXYCILLIN + POTASSIUM CLAVULANATE500MG + 125MGBILIM PHARMACEUTICALS--CERKEZKOY PLANT, 59500 CERKEZKOY, TEKIRDAG TURKEYORAL SOLID ORDINARY TABLETS1.0X3.0X5.0 TABLET BLISTER01/07/2011
1044NDA/MAL/HDP/1708LABORATORY AND ALLIED LTDHARLEYS UGANDA LIMITEDDENTAMOLACETAMINOPHEN500MGLABORATORY & ALLIED LTD-PLOT NO. 209/10349
OFF MOMBASA ROAD, NAIROBI
P.O. BOX 42875, NAIROBI, KENYA.
KENYAORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER01/07/1997
1045NDA/MAL/HDP/1709REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDLUCIN CREAMHYDROCORTISONE1%W/WREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA KENYATOPICAL EXTERNAL CREAMS1.0X10.0 G TUBE,1.0X15.0 G TUBE,1.0X5.0 G TUBE01/07/1997
1046NDA/MAL/HDP/1711KOPRAN LIMITEDTATA UGANDA LIMITEDAMYN-250AMOXYCILLIN250MGKOPRAN LIMITED-VILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIA INDIAORAL SOLID ORDINARY CAPSULES10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER01/07/1997
1047NDA/MAL/HDP/1712I CARE PHARMA LIMITEDVITACARE LTDAMPICILLIN SODIUMAMPICILLIN SODIUM500MGREYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100 CHINAPARENTERAL ORDINARY DRY VIALS1.0X10.0 VIAL CARTON01/07/2013
1048NDA/MAL/HDP/1713MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDLUMITERARTEMETHER + LUMEFANTRINE20 MG + 120 MGMACLEODS PHARMACEUTICALS LTD -PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT), INDIA. OXALIS LABS -VILLAGE THEDA P.O LODHIMAJRA, THESIL BADDI DISTRICT SOLAN HIMACHAL PRADESH INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X8.0 TABLET BLISTER,1.0X1.0X6.0 TABLET BLISTER,1.0X1.0X24.0 TABLET BLISTER,1.0X30.0X12.0 TABLET BLISTER,1.0X1.0X12.0 TABLET BLISTER,1.0X30.0X18.0 TABLET BLISTER,1.0X1.0X18.0 TABLET BLISTER,1.0X30.0X6.0 TABLET BLISTER,1.0X30.0X24.0 TABLET BLISTER01/07/2007
1049NDA/MAL/HDP/1715SHELYS PHARMACEUTICALS LTDBETA HEALTHCARE UGANDA LIMITEDMUCOLYN SYRUPAMMONIUM CHLORIDE+CHLORPHENIRAMINE+DEXTROMETHORPHAN+BROMHEXINE50MG+2MG+5MG+4MGBETA HEALTHCARE INTERNATIONAL LTD - -PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYA SHELYS PHARMACEUTICALS LTD,-NEW BAGAMOYO ROAD, MWENGE, PLOT NO 696,BLOCK NO 32, P.O.BOX 3016, DAR ES SALAAM TANZANIAORAL LIQUID ORDINARY SYRUPS1.0X1.0X100.0 ML BOTTLE07/01/11
1050NDA/MAL/HDP/1716NIRMA LIMITED (HEALTHCARE DI VISION) NIRLIFE HEALTHCARELIFE PHARMA AFRICA LIMITEDNIRMIN 5SMULTI-INGREDIENTMULTI-INGREDIENTACULIFE HEALTH CARE, FORMALLY NIRMA(HEALTHCARE DIVISION)-VILLAGE: SACHANA, TALUKA: VIRAMGAM DISTRICT: AHMEDABAD-382150 GUJARAT, INDIA INDIAPARENTERAL ORDINARY INFUSION DRY VIALS/BOTTLES1.0X500.0 ML BOTTLE01/07/2010
1051NDA/MAL/HDP/1719NIRMA LIMITED (HEALTHCARE DI VISION) NIRLIFE HEALTHCARELIFE PHARMA AFRICA LIMITEDNIRMIN 10 PLUSMULTI-INGREDIENTMULTI-INGREDIENTACULIFE HEALTH CARE, FORMALLY NIRMA(HEALTHCARE DIVISION)-VILLAGE: SACHANA, TALUKA: VIRAMGAM DISTRICT: AHMEDABAD-382150 GUJARAT, INDIA INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X500.0 ML BOTTLE01/07/2010
1052NDA/MAL/HDP/1723USV PRIVATE LIMITEDABACUS PHARMA (AFRICA) LIMITEDGROVIT MULTIVITAMIN DROPSMULTI-INGREDIENTMULTI-INGREDIENTSAKAR HEALTHCARE PVT LTD-SAKAR HEALTHCARE PVT LTD, BLOCK NO 10-13, M.N. DESA INDIAORAL LIQUID ORDINARY DROPS1.0X15.0 ML BOTTLE01/07/2000
1053NDA/MAL/HDP/1724GLAXOSMITHKLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDAVAMYS NASAL SPRAYFLUTICASONE FUROATE27.5MCG/ACTUATIONGLAXO OPERATIONS UK LTD---HARMIRE ROAD, BARNARD CASTLE, DURHAM DL128 DT UK UNITED KINGDOMNASAL TOPICAL SPRAYS WITHOUT GAS1.0X120.0 METERED DOSE CANNISTER01/07/2009
1054NDA/MAL/HDP/1725REMEDICA LTDGOODMAN INTERNATIONAL LTDMYCORIL CREAM 1%CLOTRIMAZOLE1%W/WREMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR CYPRUSTOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE01/07/2000
1055NDA/MAL/HDP/1726GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDHAVRIX 720INACTIVATED HEPATITIS A VIRUS ADSORBED ON ALUMINIUM HYDROXIDE HYDRATED720 ELISA UNITS ADSORBED ON 0.25MG ALUMINIUM HYDROXIDESMITHKLINE BEECHAM BIOLOGICALS , BELGIUM- BELGIUM BELGIUMPARENTERAL ORDINARY VIALS1.0X0.5 ML VIAL (1 DOSE)01/07/1997
1056NDA/MAL/HDP/1727MISSION PHARMAJOINT MEDICAL STORE (UPMB - UCMB)TETRACYCLINE HYDROCLORIDETETRACYCLINE HYDROCHLORIDE3%W/WNANJING BAIJINGYN PHARMACEUTICALS CO.LTD NO-1 HUIZHONG ROAD NANJING ECONOMIC AND TECHNICAL DEVELOPMENT ZONECHINATOPICAL EXTERNAL OINTMENTS1.0X15.0 G TUBE01/07/2014
1057NDA/MAL/HDP/1728ARISTO PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDDELISPRIN 75MGASPIRIN75MGARISTO PHARMACEUTICALS PVT LTD -PLOT NO 208 NEW INDUSTRIAL GREEN NO2 MANDIDEED 462046INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X10.0X10.0 TABLET STRIP,1.0X10.0X14.0 TABLET STRIP01/07/2007
1058NDA/MAL/HDP/1730COSMOS LTDASTRA PHARMA (U) LIMITEDZITHROXAZITHROMYCIN500MGCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI KENYAORAL SOLID ORDINARY TABLETS1.0X3.0 TABLET BLISTER01/07/2008
1059NDA/MAL/HDP/1731REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDMEDIVEN-S OINTMENTBETAMETHASONE VALERATE + SALICYLIC ACID0.05%W/W + 3%W/WREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA KENYATOPICAL EXTERNAL OINTMENTS1.0X15.0 G TUBE01/07/1997
1060NDA/MAL/HDP/1732MICRO LABS LTDLABOREX UGANDA LIMITEDCEFEX-250CEPHALEXIN250MGMICROLABS LIMITED-PLOT NO. 121-124, KIADB, BOMMASANDRA , -JIGNI LINK ROAD, ANEKUL TALUK,BANGALORE, KARNATAKA, INDIA INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER01/07/1999
1061NDA/MAL/HDP/1734KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMOMINTCOMPOUND MAGNESIUM TRISILICATE500MGTIL HEALTH CARE-PLOT 100,WEST,R-5,SOUTH;SRICITY SEZ,CHERIVI,IRUHULAM,PSOT,SATYAVEDU MANDAL,CHITOOR DISTRICT-ANDRA PRADESH-517588, INDIA INDIAORAL SOLID ORDINARY CHEWABLE TABLETS10.0 TABLET CONTAINER,250.0 TABLET CONTAINER,500.0 TABLET CONTAINER,100.0 TABLET CONTAINER,1000.0 TABLET CONTAINER07/01/97
1062NDA/MAL/HDP/1736MEDOCHEMIE LTDBOOTS PHARMACEUTICALS LIMITEDKLERIMEDCLARITHROMYCIN500MGMEDOCHEMIE LTD-1-10 CONSTANTINOUPOLEOS TREET 3011 LIMASSOLCYPRUSORAL SOLID ORDINARY TABLETS1.0X2.0X7.0 TABLET BLISTER01/07/2009
1063NDA/MAL/HDP/1738ALCON PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.TEARS NATURALE IINATURAL TEARS15MLALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUM BELGIUMOPHTHALMIC DROPS1.0X15.0 ML BOTTLE01/07/1997
1064NDA/MAL/HDP/1739MEDOCHEMIE LTDBOOTS PHARMACEUTICALS LIMITEDMELOXMELOXICAM15MG MEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA CYPRUSORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER01/07/2009
1065NDA/MAL/HDP/1741AMMAN PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDNEOPRED-PPREDNISOLONE ACETATE + NEOMYCIN SULPHATE+ POLYMYXIN-B5MG/ML +5MG/ML + 1M I.U/MLAMMAN PHARMACEUTICALS INDUSTRIES .-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDAN JORDANOPHTHALMIC DROPS1.0X1.0X10.0 ML VIAL01/07/2005
1066NDA/MAL/HDP/1743MEDOCHEMIE LTDBOOTS PHARMACEUTICALS LIMITEDDAPRILLISINOPRIL DIHYDRATE10MGMEDOCHEMIE LTD-1-10 CONSTANTINOUPOLEOS TREET 3011 LIMASSOLCYPRUSORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2009
1067NDA/MAL/HDP/1745AMMAN PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDAPIGENGENTAMYCIN SULPHATE0.3%W/VAMMAN PHARMACEUTICALS INDUSTRIES-AMMAN PHARMACEUTICAL INDUSTRIES-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDAN JORDANOPHTHALMIC DROPS1.0X1.0X10.0 ML VIAL01/07/2005
1068NDA/MAL/HDP/1747IPCA LABORATORIES LTDMEDVIN PHARMA LIMITEDPRESARTAN H 50LOSARTAN POTASSIUM + HYDROCHLOROTHIAZIDE 50MG + 12.5MG IPCA LABORATORIES LTD-PLOT NO. 255/1,
VILLAGE ATHAL,
SILVASSA-396230,
DADRA AND NAGAR HAVELI, INDIA.
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X14.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER01/07/2008
1069NDA/MAL/HDP/1748AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAZ-500AZITHROMYCIN500MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY CAPSULES1.0X3.0 CAPSULE BLISTER01/07/2011
1070NDA/MAL/HDP/1749LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDVITAMIN B COMPLEXVITAMIN B COMPLEXN/ALINCOLN PARENTERAL LTD-11, TRIMUL ESTATE KHATRAJ DISI. GANDHINAGAR-38272, GUJARAT INDIAPARENTERAL ORDINARY AMPOULES1.0X10.0X10.0X2.0 ML AMPOULE01/07/2005
1071NDA/MAL/HDP/1750AMMAN PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDAPIFLOXNORFLOXACIN0.3%W/VAMMAN PHARMACEUTICALS INDUSTRIES-AMMAN PHARMACEUTICAL INDUSTRIES-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDAN JORDANOPHTHALMIC DROPS1.0X1.0X10.0 ML VIAL01/07/2005
1072NDA/MAL/HDP/1751AMMAN PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDOPTIFUCINFUSIDIC ACID1%W/VAMMAN PHARMACEUTICALS INDUSTRIES .-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDAN JORDANOPHTHALMIC DROPS1.0X5.0 ML AMPOULE01/07/2005
1073NDA/MAL/HDP/1754AMMAN PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDAPIMOLTIMOLOL MALEATE0.5%W/VAMMAN PHARMACEUTICALS INDUSTRIES .-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDAN JORDANOPHTHALMIC DROPS1.0X1.0X5.0 ML VIAL01/07/2005
1074NDA/MAL/HDP/1755MEMPHIS COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDDOPAGON TABLETSBROMOCRIPTINE2.5MGMEMPHIS COMPANY--8 EL SAWAH STREET, CAIRO. EGYPT EGYPTORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER01/07/1999
1075NDA/MAL/HDP/1758AMMAN PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDAPICORTPREDNISOLONE ACETATE0.12%W/VAMMAN PHARMACEUTICALS INDUSTRIES .-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDAN JORDANOPHTHALMIC DROPS1.0X1.0X10.0 ML VIAL01/07/2005
1076NDA/MAL/HDP/1761EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDATAZOR-RATAZANAVIR + RITONAVIR300 MG + 100 MGEMCURE PHARMACEUTICALS LTD .-PLOT NO. P-2 IT-BT PARK PHASE II MIDC HINJWADI PUNE 411057INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X30.0 TABLET BOTTLE07/01/14
1077NDA/MAL/HDP/1762AMMAN PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDAPITROPINATROPINE1%W/VAMMAN PHARMACEUTICALS INDUSTRIES .-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDAN JORDANOPHTHALMIC DROPS1.0X1.0X10.0 ML VIAL01/07/2005
1078NDA/MAL/HDP/1763LABORATORY&ALLIED LTDHARLEYS UGANDA LIMITEDASPIRIN TABLETS BPACETYL SALICYLIC ACID300MGLABORATORY & ALLIED LTD.-PLOT 209/10349 OFF MOMBASA RD NAIROBIKENYAORAL SOLID ORDINARY TABLETS1.0X20.0X10.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER01/07/1997
1079NDA/MAL/HDP/1764JOHNSON &JOHNSON (PTY) LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDFRESH BURST LISTERINEALCOHOL + THYMOL95 % W/V + 12 MGJOHNSON&JOHNSON PTY LTD..-241 MAIN ROAD RETREAT 794
SOUTH AFRICAORAL LIQUID ORDINARY LIQUIDS1.0X250.0 ML CONTAINER,1.0X500.0 ML CONTAINER01/07/2006
1080NDA/MAL/HDP/1765UMEDICA LABORATORIES PVT LTDGITTOES PHARMACEUTICALS LIMITEDRILIF PLUSACECLOFENAC + PARACETAMOL100MG + 500MGUMEDICA LABORATORIES PVT LTD-PLOT NO. 221, 2ND PHASE, GIDC, VAPI 396195, GUJARAT. INDIA. INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2012
1081NDA/MAL/HDP/1766RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDCOLDEASE CAPSULESPARACETAMOL+CAFFEINE CITRATE+CHLORPHENIRAMINE MALEATE+PSEUDOEPHEDRINE HYDROCHLORIDE400MG+30MG+4MG+30MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA UGANDAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER01/07/2005
1082NDA/MAL/HDP/1767EVA PHARMAWIDE SPECTRUM ENTERPRISES (U) LIMITEDPROSTEROLALFUZOSIN HYDROCHLORIDE10MGEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT EGYPTORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER01/07/2013
1083NDA/MAL/HDP/1768BETA HEALTHCARE UGANDA LIMITEDBETA HEALTHCARE UGANDA LIMITEDULTIVA INJECTION 2MGREMIFENTANIL2MGGLAXOSMITHKLINE MANUFACTURING SPA ,.,-STRADA PROVINCIALE ASOLANA, 90-43056, S.POLO DI TORRILE (PARMA) ITALYPARENTERAL ORDINARY DRY VIALS1.0X1.0 VIAL CARTON01/07/1999
1084NDA/MAL/HDP/1769GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDENGERIX-B VACCINEHEPATITIS B SURFACE ANTIGEN10MCG/MLGLAXOSMITHKLINE BOILOGICALS-S.A RUE DE I'INSTITUT 89 B-1330 RIXENSARTBELGIUMPARENTERAL ORDINARY VIALS1.0X10.0X0.5 ML VIAL (1 DOSE),1.0X25.0X0.5 ML VIAL (1 DOSE)01/07/1997
1085NDA/MAL/HDP/1771MISSION PHARMA A/SJOINT MEDICAL STORE (UPMB - UCMB)ORAL REHYDRATION SALTS BPMULTI-INGREDIENTMULTI-INGREDIENTMEDICAMEN BIOTECH LTD-SP-1192, A &B, PHASE –IV,
INDUSTRIAL AREA BHIWADI -301019 DIST. ALWAR (RAJASTHAN)
INDIAORAL LIQUID ORDINARY UNIT DOSE POWDERS1.0X100.0X20.5 G SACHET01/07/2010
1086NDA/MAL/HDP/1772SUN PHARMACEUTICAL INDUSTRIES LIMITEDSTAR PHARMACEUTICALS LTDGESTID TABLETSCOMPOUND MAGNESIUM TRISILICATE385MGSUN PHARMACEUTICAL INDUSTRIES LIMITED,-INDUSTRIAL AREA NO.3, A.B.ROAD DEWAS,455001 MADHYA PRADESH INDIA. INDIAORAL SOLID ORDINARY TABLETS1.0X5.0X4.0 TABLET BLISTER01/07/2000
1087NDA/MAL/HDP/1773MICRO LABS LTDLABOREX UGANDA LIMITEDLEVOBACT 500LEVOFLOXACIN HEMIHYDRATE500MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X20.0X5.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER01/07/2005
1088NDA/MAL/HDP/1777CIPLA LTDQUALITY CHEMICALS LTD - HUMANNUZAC 20FLUOXETINE20MGCIPLA LTD -PLOT NO. L-139, VERNA, GOA 403 722 INDIA INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER01/07/2003
1089NDA/MAL/HDP/1778PHARCO PHARMACEUTICALSWIDE SPECTRUM ENTERPRISES (U) LIMITEDFARCONCIL 500MG CAPSULESAMOXYCILLIN TRIHYDRATE500MGPHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT.
P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT
EGYPTORAL SOLID ORDINARY CAPSULES1.0X2.0X10.0 CAPSULE BLISTER01/07/1998
1090NDA/MAL/HDP/1779BROOKES PHARMACEUTICAL LABORATORIES LHARLEYS UGANDA LIMITEDPYODINE SOLUTIONPOVIDONE IODINE10.0G/100MLBROOKES PHARMACEUTICALS LABORATORIES (PAKISTAN) LTD-PLOT 58 SECTOR 15 KORANGI
INDUSTRIAL AREA, KARACHI-PAKISTAN
PAKISTANTOPICAL EXTERNAL LIQUIDS1.0X60.0 ML BOTTLE,1.0X450.0 ML BOTTLE07/01/06
1091NDA/MAL/HDP/1780RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDRENETRIM SUSPENSIONCO-TRIMOXAZOLE240MG/5MLRENE INDUSTRIES LIMITED-PLOT 680 KAMULI KIREKAUGANDAORAL LIQUID ORDINARY SUSPENSIONS1.0X60.0 ML BOTTLE01/07/2000
1092NDA/MAL/HDP/1781ASTRAZENECAMACNAUGHTON LIMITEDARIMIDEXANASTROZOLE1MGASTRAZENECA PHARMACEUTICALS LP-NEWARK, DELAWARE UNITED STATESORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X14.0 TABLET BLISTER01/07/2000
1093NDA/MAL/HDP/1782AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDCO-METHERARTEMETHER + LUMEFANTRINEPER 5ML: 15MG + 90MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X60.0 ML BOTTLE,1.0X30.0 ML BOTTLE01/07/2010
1094NDA/MAL/HDP/1783LABORATORY AND ALLIED LTDHARLEYS UGANDA LIMITEDLAEOVATE OINTMENTBETAMETHASONE VALERATE0.1%W/WLABORATORY & ALLIED LTD--PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, MOMBASA ROAD P.O. BOX 42875, GPO 00100, NAIROBI, KENYA KENYATOPICAL EXTERNAL OINTMENTS1.0X1.0X15.0 G TUBE01/07/1997
1095NDA/MAL/HDP/1784MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDAZICURE-500AZITHROMYCIN500MGMACLEODS PHARMACEUTICALS LIMITED (BLOCK –N1)-VILLAGE THEDA, P.O. LODHI MAJRA,TEHSIL BADDI, HIMACHAL PRADESH -174101,INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0 TABLET BLISTER01/07/2005
1096NDA/MAL/HDP/1785BETA HEALTHCARE UGANDA LIMITEDBETA HEALTHCARE UGANDA LIMITEDACTION TABLETSACETYL SALICYLATE + CAFFEINE + PARACETAMOL600MG+50MG+300MGBETA HEALTHCARE INTERNATIONAL LTD - -PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYA KENYAORAL SOLID ORDINARY TABLETS1.0X200.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,1.0X110.0 TABLET STRIP,1.0X12.0 TABLET BLISTER01/07/1997
1097NDA/MAL/HDP/1786AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGONAC TABLETS (THANE)DICLOFENAC50MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER01/07/2001
1098NDA/MAL/HDP/1790REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDUNITRIM TABLETCO-TRIMOXAZOLE480MGREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA KENYAORAL SOLID ORDINARY TABLETS10.0X10.0 TABLET BLISTER,1.0X250.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER01/07/1997
1099NDA/MAL/HDP/1792DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDGAMA PHARMACEUTICALS (U) LIMITEDLIPODARATORVASTATIN20MGDAR AL DAWA-NA'UR PLANT AMMANJORDANORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2013
1100NDA/MAL/HDP/1793MACNAUNGHTON LIMITEDMACNAUGHTON LIMITEDSYMBICORT TURBUHALERBUDESONIDE+FORMOTEROL80MCG+4.5MCG/DOSEASTRAZENECA AB,-GARTUNA & SNACKVIKEN STOCKHOLM SWEDENLUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER1.0X60.0 DOSE CANNISTER01/07/2001
1101NDA/MAL/HDP/1795KOPRAN LIMITEDTATA UGANDA LIMITEDAMPIK-250AMPICILLIN250MGKOPRAN LIMITED-VILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIA INDIAORAL SOLID ORDINARY CAPSULES10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER01/07/1997
1102NDA/MAL/HDP/1796AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDZAHA 250AZITHROMYCIN250 MGAJANTA PHARMA LIMITED PAITHAN-MANUFACTURING UNIT B-4/5/6 MIDC PAITHAN DISTRICT AURANGABAD 431 148 MAHARASTRA STATE INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER,1.0X10.0X1.0X6.0 TABLET BLISTER01/07/2006
1103NDA/MAL/HDP/1797KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTDTATA UGANDA LIMITEDAMPICILLIN+CLOXACILLINAMPICILLIN + CLOXACILLIN250 MG + 250 MGKARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD- #14, II PHASE PIA, BANGALORE 560058 INDIAPARENTERAL ORDINARY DRY VIALS1.0X10.0X500.0 MG VIAL01/07/2010
1104NDA/MAL/HDP/1798INTAS PHARMACEUTICALS LIMITEDNORVIK ENTERPRISES LIMITEDCARDITAS RETARDNIFEDIPINE20MGINTAS PHARMACEUTICALS LTD, VATVA-7/3 G.I.D.C. ESTATE, PHASE-1, B/H DENA BANK VATVA, AHMEDABAD-382 445 GUJARAT, INDIA
INTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIA
INDIAORAL SOLID RETARD FILM-COATED TABLETS10.0X10.0 TABLET BLISTER01/07/1997
1105NDA/MAL/HDP/1799INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDSECZOL DSSECNIDAZOLE1GMINTAS PHARMACEUTICALS LTD-PLOT 457/458, SARKHEJ BAVLA HIGHWAY
MATODA 382 210 TAL: SANAND, AHMEDABAD, INDIA
INDIAORAL SOLID ORDINARY TABLETS1.0X2.0 TABLET BLISTER01/07/2001
1106NDA/MAL/HDP/1800MICRO LABS LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDAMLONG-10AMLODIPINE5MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER01/07/2009
1107NDA/MAL/HDP/1801LABORATORY&ALLIED LTDHARLEYS UGANDA LIMITEDLABESTEN PESSARIESCLOTRIMAZOLE100MGLABORATORY & ALLIED LTD.---PLOT 209/10349 OFF MOMBASA RD NAIROBIKENYAVAGINAL TABLETS1.0X1.0X6.0 PESSARY STRIP01/07/1997
1108NDA/MAL/HDP/1803ASTRA ZENECA ABMACNAUGHTON LIMITEDNEXIUM 40MGESOMEPRAZOLE40MGASTRAZENECA AB.-GARTUNA & SNACKVIKEN STOCKHOLMSWEDENORAL SOLID ORDINARY FILM-COATED TABLETS1.0X7.0 TABLET BLISTER,1.0X14.0 TABLET CARTON,1.0X28.0 TABLET CARTON01/07/2001
1109NDA/MAL/HDP/1804TORRENT PHARMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.LISTRILLISINOPRIL5MGTORRENT PHARMACEUTICAL LTD-AHMEDABAD-MEHSANA HIGHWAY,TALUKA-KADI,DIST.MEHSANA,INDRAD-382721 INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2001
1110NDA/MAL/HDP/1805MSD (PTY) LIMITED SAPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDJANUMETSITAGLIPTIN + METFORMIN HYDROCHLORIDE50MG + 1000MGAESICA QUEESNBOROUGH LTD .-NORTH ROAD, QUEENBOROUGH KENT ME 11 5EL, UNITED KINGDOM UNITED KINGDOMORAL SOLID ORDINARY FILM-COATED TABLETS1.0X4.0X14.0 TABLET BLISTER01/07/2014
1111NDA/MAL/HDP/1807GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDAMPICLOX NEONATAL DROPSAMPICILLIN + CLOXACILLIN60 MG / 0.6 ML + 30 MG / 0.6 MLMEDREICH STERILAB LTD-12TH MILE, OLD MADRAS ROAD, VIRGONAGOR, BANGALORE 560049, INDIA INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X8.0 ML BOTTLE07/01/97
1112NDA/MAL/HDP/1808ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDASTACIDMAGNESIUM TRISILICATE370MGASTRA LIFE CARE (INDIA) PVT LIMITED-57/P RAJODA
382220 BAVIA
AHMEDABAD INDIA
INDIAORAL SOLID ORDINARY CHEWABLE TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER01/07/1997
1113NDA/MAL/HDP/1809AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOVIT-6PYRIDOXINE25MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER01/07/2004
1114NDA/MAL/HDP/1810AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOTRITRIFLUOPERAZINE5MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER01/07/2010
1115NDA/MAL/HDP/1811CIPLA LTDQUALITY CHEMICALS LTD - HUMANDUOVIR TABLETSZIDOVUDINE+ LAMIVUDINE300MG + 150MGCIPLA LTD---PLOT NO. 143 AND L-144A VERNA IND. ESTATE SALCETTE GOA 403 722 CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED - -PLOT 1-7 1ST RING ROAD, LUZIRA, KAMPALA INDIAORAL SOLID ORDINARY TABLETS1.0X6.0X10.0 TABLET BLISTER,1.0X60.0 TABLET BOTTLE01/07/2001
1116NDA/MAL/HDP/1812RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDREQUIN TABLETSQUININE SULPHATE300MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA UGANDAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER01/07/2001
1117NDA/MAL/HDP/1813DAWA LIMITEDSUPER MEDIC LTDMOXAFORTEAMOXICILLIN + FLUCLOXACILLIN125 MG + 125MGDAWA LTD-BABA DOGO ROAD RUARAKAKENYAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE01/07/2014
1118NDA/MAL/HDP/1815GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDSUPIROCIN OINTMENTMUPIROCIN2%W/WGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D INDIATOPICAL EXTERNAL OTHER OINTMENTS1.0X15.0 G TUBE01/07/2003
1119NDA/MAL/HDP/1816MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDDRESS UP CREAMNEOMYCIN SULPHATE0.5%W/WTORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506INDIATOPICAL EXTERNAL CREAMS1.0X30.0 G TUBE01/07/1998
1120NDA/MAL/HDP/1821BLUE CROSS LABORATORIES LTDSTAR PHARMACEUTICALS LTDMEFTAL 500 TABLETSMEFENAMIC ACID500MGBLUE CROSS LABORATORIES LTD-L-17, VERNA INDUSTRIAL ESTATE,VERNA GOA-403722 INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET STRIP01/07/1997
1121NDA/MAL/HDP/1822RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDEPHEDRINEEPHEDRINE HYDROCHLORIDE30MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA UGANDAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER01/07/2005
1122NDA/MAL/HDP/1824NABIQASIM INDUSTRIES (PVT) LIMITEDJEET PHARMACEUTICALS LIMITEDGLANDIN E2 GELDINOPROSTONE0.5MGNABIQASIM INDUSTRIES (PVT) LTD?-17/24,KORANGI INDUSTRIAL AREA, KORANGI, KARACHI- PAKISTAN.
PAKISTANTOPICAL EXTERNAL GELS AND SOLS1.0X3.0 G TUBE WITH STERILE CATHETER01/07/2006
1123NDA/MAL/HDP/1825RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDCOLDEASE SYRUPPARACETAMOL+CHLORPHENIRAMINE MALEATE+PSEUDOEPHEDRINE HYDROCHLORIDE120MG+2MG+15MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA UGANDAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE01/07/2005
1124NDA/MAL/HDP/1826WIN-MEDICARE LTDSURGIPHARM (U) LIMITEDLOGICAN-200FLUCONAZOLE200MGWIN-MEDICARE PRIVATE LIMITED-MEERUT-MUZAFFARNAGAR ROAD, MODIPURAM - 250110 UTTAR PRADESH INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X4.0 CAPSULE BLISTER07/01/04
1125NDA/MAL/HDP/1827REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDALBASOL SUSPENSIONALBENDAZOLE200MG/5MLREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA KENYAORAL LIQUID ORDINARY SUSPENSIONS1.0X10.0 ML BOTTLE01/07/2006
1126NDA/MAL/HDP/1828ASTRAZENECAMACNAUGHTON LIMITEDTENORETATENOLOL + CHLORTHALIDONE50 MG + 12.5 MGASTRA ZENECA UK LIMITED-SILK ROAD BUSINESS PARK,MACCLESFIELD,CHESHIRE SK 10 2NA, UNITED KINGDOMORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X14.0 TABLET BLISTER01/07/1997
1127NDA/MAL/HDP/1832ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDDICLOASDICLOFENAC SODIUM50MGASTRA LIFE CARE(INDIA) PVT LTD-57/P, POJODA, 382220, BOVIA, AHMEDOBAD, INDIA INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X5.0X20.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER01/07/2007
1128NDA/MAL/HDP/1833ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDASMOXAMOXICILLIN500MGASTRA LIFE CARE (INDIA) PVT-SURVEY NO.57/P, SARKHEJ-BAVLA HIGHWAY, POST- RAJOD-382220, TALUKA-BAVLA, DIST-AHMEDABAD. INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER01/07/2011
1129NDA/MAL/HDP/1840REMEDICA LTDGOODMAN INTERNATIONAL LTDOVA-MITCLOMIPHENE50MGREMEDICA LIMITED -AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUS CYPRUSORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER01/07/2011
1130NDA/MAL/HDP/1841MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDFUNGNIL CREAMCLOTRIMAZOLE1%W/WTORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506INDIATOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE01/07/2000
1131NDA/MAL/HDP/1842KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDSUGAQUIN TABLETSCHLOROQUINE PHOSPHATE250MGKAMPALA PHARMACEUTICALS INDUSTIES-PLOT NO M44B STRETCHER ROAD INTINDAUGANDAORAL SOLID ORDINARY OTHER COATED TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER01/07/2002
1132NDA/MAL/HDP/1843USV PRIVATE LIMITEDABACUS PHARMA (AFRICA) LIMITEDECORIN-75ASPIRIN75MGREMEDEX PHARMA-B-249/250 PEENYA INDUSTRIAL ESTATE BANGALORE 560 058
INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2005
1133NDA/MAL/HDP/1844GUILIN PHARMACEUTICALS CO.LTDSTAR PHARMACEUTICALS LTDSULFAMETHOXAZOLE / TRIMETHOPRIMSULFAMETHOXAZOLE / TRIMETHOPRIM800MG /160MGGUILIN PHARMACEUTICAL CO.LTD.-NO.43 QUILIDIAN ROAD GUILIN 541002, GUANGXI, CHINA CHINAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER01/07/2011
1134NDA/MAL/HDP/1846LEBEN LABORATORIES PVT LTDANDYCO PHARMACY (UGANDA) LTDANTAGIT DS GEL ORANGE FLAVOURALUMINIUM HYDROXIDE + MAGNESIUM + SIMETHICONE400MG + 400MG + 50MGLEBEN LABORATORIES PVT. LTD.-PLOT NO. L-4, PHASE –III, M.I.D.C, AKOLA, 444104, MAHARASHTRA, INDIA. INDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X170.0 ML BOTTLE07/01/13
1135NDA/MAL/HDP/1847LEBEN LABORATORIES PVT. LTD., INDIAANDYCO PHARMACY (UGANDA) LTDMOXILEB-250 CAPSULEAMOXICILLIN250MGLEBEN LABORATORIES PVT. LTD.-PLOT NO. L-4, PHASE –III, M.I.D.C, AKOLA, 444104, MAHARASHTRA, INDIA. INDIAORAL SOLID ORDINARY CAPSULES1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0X10.0 CAPSULE BLISTER01/07/2007
1136NDA/MAL/HDP/1848LABORATORY&ALLIED LTDHARLEYS UGANDA LIMITEDPARATALPARACETAMOL500MGLABORATORY & ALLIED LTD--PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, MOMBASA ROAD P.O. BOX 42875, GPO 00100, NAIROBI, KENYA KENYAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER01/07/1997
1137NDA/MAL/HDP/1849PHARMACIE BETHELABACUS PARENTERAL DRUGS LIMITEDCIFINCIPROFLOXACIN0.2%W/VABACUS PARENTERAL DRUGS LTD-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE,
MUKONO
UGANDAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X100.0 ML BOTTLE01/07/2011
1138NDA/MAL/HDP/1850RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDALZOL TABLETSALBENDAZOLE400MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA UGANDAORAL SOLID ORDINARY TABLETS1.0X500.0 TABLET CONTAINER01/07/2010
1139NDA/MAL/HDP/1851PHILLIPS PHARMACEUTICALS LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDCAPSIFENAC GELCAPSAICIN + DICLOFENAC + LEVOMENTHOL + METHYL SALICYLATE0.438 G + 0.335 G + 0.135 G + 0.918 GSTEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA INDIATOPICAL EXTERNAL EMULSION GELS1.0X1.0X20.0 G TUBE,1.0X1.0X10.0 G TUBE01/07/2011
1140NDA/MAL/HDP/1856COSMOS LTDASTRA PHARMA (U) LIMITEDPROPRANOLOL TABLETS B.P. 40MGPROPRANOLOL HYDROCHLORIDE40MGCOSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA KENYAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER01/07/1998
1141NDA/MAL/HDP/1861GUILIN PHARMACEUTICALS CO LTDSTAR PHARMACEUTICALS LTDSULFAMETHOXAZOLE / TRIMETHOPRIMSULFAMETHOXAZOLE / TRIMETHOPRIM400MG /80MGGUILIN PHARMACEUTICAL CO.LTD.-NO.43 QUILIDIAN ROAD GUILIN 541002, GUANGXI, CHINA CHINAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER01/07/2011
1142NDA/MAL/HDP/1863AMOUN PHARMACEUTICALS COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDORACURE GELLIDOCAINE HCL+CETYL PYRIDINUM CHLORIDE2 GM+0.1 GMAMOUN PHARMACEUTICALS CO. S.A.E-1ST INDUSTRIAL ZONE, EL-OBOUR CITY, EGYPT. EGYPTORAL TOPICAL GELS AND SOLS1.0X15.0 G TUBE01/07/2004
1143NDA/MAL/HDP/1864NORVATIS PHARMA AG- SWITZERLANDLABOREX UGANDA LIMITEDPATANOLOLOPATADINE HYDROCHLORIDE0.1%W/VALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUM BELGIUMOPHTHALMIC DROPS1.0X5.0 ML VIAL07/01/09
1144NDA/MAL/HDP/1865FDC LTDAIVEEN (U) LIMITEDMYCODERM-C POWDERCLOTRIMAZOLE1%W/WFDC LIMITED -B-8, M.I.D.C., INDUSTRIAL AREA, WALUJ – AURANGABAD- 431 136 MAHARASHTRA, INDIA. INDIATOPICAL EXTERNAL POWDERS1.0X75.0 G CONTAINER07/01/14
1145NDA/MAL/HDP/1866JASSEN-CILAG (PTY) LTDLABOREX UGANDA LIMITEDNIZORALKETOCONAZOLE20MG/GSPECPHARM HOLDINGS- 15TH ROAD HALFWAY HOUSESOUTH AFRICATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE01/07/1997
1146NDA/MAL/HDP/1869MERCK SHARP & DOHME BVPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDSTOCRIN 200EFAVIRENZ200MG ZHEJIANG HUAHAI PHARMACEUTICAL CO. LTD-XUNQIAO, LINHAI, ZHEJIANG PROVINCE 317024 PEOPLES’ REPUBLIC OF CHINA MERCK SHARP & DOHME.-WAADERWAG 39, POSTBUS 581. 2003 PC HAARLEM NETHERLANDSORAL SOLID ORDINARY FILM-COATED TABLETS1.0X90.0 TABLET BOTTLE01/07/2008
1147NDA/MAL/HDP/1873MSD (PTY) LIMITED SAPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDJANUMETSITAGLIPTIN + METFORMIN HYDROCHLORIDE50MG + 850MGAESICA QUEESNBOROUGH LTD .-NORTH ROAD, QUEENBOROUGH KENT ME 11 5EL, UNITED KINGDOM UNITED KINGDOMORAL SOLID ORDINARY TABLETS1.0X4.0X14.0 TABLET BLISTER01/07/2014
1148NDA/MAL/HDP/1877RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDMINT-O-COOLDRIED ALUMINIUM HYDROXIDE + MAGNESIUM TRISILICATE120MG + 250MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA UGANDAORAL SOLID ORDINARY TABLETS1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER01/07/2007
1149NDA/MAL/HDP/1879SPARSH BIO-TECH PVT LTDABACUS PHARMA (AFRICA) LIMITEDSPENIVPHENOXYMETHYL PENICILLIN250MGSPARSH BIO-TECH LTD-PLOT NO.1 SURVEY NO.242/234/244, VILLAGE LAKHABARAD, JAMNAGAR-361006 INDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER01/07/2004
1150NDA/MAL/HDP/1880SPARSH BIO-TECH PVT. LTDABACUS PHARMA (AFRICA) LIMITEDSPAMCLOXAMPICILLIN + CLOXACILLIN250 MG + 250 MGSPARSH BIO-TECH LTD-PLOT NO.1 SURVEY NO.242/234/244, VILLAGE LAKHABARAD, JAMNAGAR-361006 INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER,1.0X100.0X10.0 CAPSULE BLISTER01/07/2004
1151NDA/MAL/HDP/1881SPARSH BIO-TECH PVT. LTDABACUS PHARMA (AFRICA) LIMITEDSPAMOXAMOXYCILLIN250MGSPARSH BIO-TECH PVT. LIMITED-PLOT NO. 1;SURVEY NO. 242/243/244,LAKHABAVAD,JAMNAGAR-361 006, INDIA.
INDIAORAL SOLID ORDINARY CAPSULES1.0X100.0X10.0 CAPSULE BLISTER,1.0X1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER01/07/2004
1152NDA/MAL/HDP/1882SPARSH BIO-TECH PVT LTDABACUS PHARMA (AFRICA) LIMITEDSPAMCILAMPICILLIN250MGSPARSH BIO-TECH LTD-PLOT NO.1 SURVEY NO.242/234/244, VILLAGE LAKHABARAD, JAMNAGAR-361006 INDIAORAL SOLID ORDINARY CAPSULES1.0X100.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER01/07/2004
1153NDA/MAL/HDP/1886KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAM QUIN TABLETSCHLOROQUINE PHOSPHATE250MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALAUGANDAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2001
1154NDA/MAL/HDP/1887KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMADOLPARACETAMOL500MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALAUGANDAORAL SOLID ORDINARY TABLETS1.0X100.0X10.0 TABLET BLISTER,100.0 TABLET CONTAINER,250.0 TABLET CONTAINER,500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER01/07/1997
1155NDA/MAL/HDP/1888KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAM QUIN SYRUPCHLOROQUINE PHOSPHATE80MG/5MLKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD-PLOT M 444B STRETCHER ROAD NTINDAUGANDAORAL LIQUID ORDINARY SYRUPS1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE01/07/2001
1156NDA/MAL/HDP/1889KAMPALA PHARMACEUTICAL INDUSTRIES LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAM PREDSOLPREDNISOLONE5MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALAUGANDAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X500.0 TABLET CONTAINER,1.0X250.0 TABLET CONTAINER,1.0X100.0 TABLET CARTON,1.0X10.0 TABLET CARTON01/07/1997
1157NDA/MAL/HDP/1891MACLEODS PHARMACEUTICAL LTDNORVIK ENTERPRISES LIMITEDLEVOMAC 500LEVOFLOXACIN500MGMACLEODS PHARMACEUTICALS LTD -PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT), INDIA. INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X20.0X5.0 TABLET BLISTER01/07/2005
1158NDA/MAL/HDP/1892MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDLEVOMAC 250LEVOFLOXACIN250MGMACLEODS PHARMACEUTICALS LTD -PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT), INDIA. INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X20.0X5.0 TABLET BLISTER01/07/2012
1159NDA/MAL/HDP/1894KOPRAN LIMITEDTATA UGANDA LIMITEDTRIM-480CO-TRIMOXAZOLE480MGKOPRAN LIMITED-VILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIA INDIAORAL SOLID ORDINARY TABLETS10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER01/07/1997
1160NDA/MAL/HDP/1895AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDTRIMAGO (PAEDIATRIC)CO-TRIMOXAZOLE100MG/20MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER01/07/2007
1161NDA/MAL/HDP/1898WIN-MEDICARE LTDSURGIPHARM (U) LIMITEDZAPACID - 30LANSOPRAZOLE30MGWIN MEDICARE PVT LIMITED-MEERUT, MUZAFFARNAGER ROAD, MODIPURAM – 250110, UTTAR
PRADESH - INDIA
INDIAORAL SOLID ORDINARY CAPSULES3.0X10.0 CAPSULE BLISTER01/07/2001
1162NDA/MAL/HDP/1899INDOCO REMEDIES LIMITEDTATA UGANDA LIMITEDTUSPRESS COUGH SUPPRESSANTMULTI-INGREDIENTMULTI-INGREDIENTINDOCO REMEDIES LTD - 0-.L-14 VERNA INDUSTRIAL AREA, VERNA, GOA-403722 INDIAORAL LIQUID ORDINARY SYRUPS1.0X1.0X100.0 ML BOTTLE01/07/2010
1163NDA/MAL/HDP/1900AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOM 20OMEPRAZOLE20MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY CAPSULES1.0X2.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE STRIP01/07/2007
1164NDA/MAL/HDP/1901AJANTA PHARMA LTD 31-0ABACUS PHARMA (AFRICA) LIMITEDIBUMOLIBUPROFEN + PARACETAMOL100MG + 162.5 MG /5MLAJANTA PHARMA LIMITED-31-0 MIDC INDUSTRIAL AREA CHIKALTHANA 431210 DIST AURANGABAD MAHARASHTRA STATEINDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE01/07/2013
1165NDA/MAL/HDP/1902KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMODIUMLOPERAMIDE HYDROCHLORIDE2MGKAMPALA PHARMECEUTICALS INDUSTRIES LTD.-PLOT M444B STRETCHER RD, NTINDA KLA UGANDA UGANDAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER01/07/1997
1166NDA/MAL/HDP/1903DAFRA PHARMA LTDLABOREX UGANDA LIMITEDARTESIANE 100ARTEMETHER100MG/MLROTEXMEDICA GMBH ARZEIMITTEL WERK-BUNSENSTRASSE 4, 22946 TRITTAU GERMANYPARENTERAL ORDINARY I M AMPOULES1.0X10.0X1.0 ML AMPOULE01/07/2007
1167NDA/MAL/HDP/1906ACG PHARMAPACK PVT. LTDCIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDEFAVIRENZ TABLETS 600MGEFAVIRENZ600MGCIPLA QUALITY CHEMICAL INDUSTRIES LIMITED-PLOT 1-7, LUZIRA UGANDAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X30.0 TABLET CONTAINER01/07/2013
1168NDA/MAL/HDP/1907CIPLA LTDQUALITY CHEMICALS LTD - HUMANABACAVIRABACAVIR300MGCIPLA LTD-UNIT I & II A-32 & A-42 MIDC PATALGANGA 410220, DIST- RAIGAD, MAHARASHTRA, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X60.0 TABLET BOTTLE01/07/2004
1169NDA/MAL/HDP/1908CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDOLMY 20OLMESARTAN20MGCADILA HEALTH CARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2011
1170NDA/MAL/HDP/1911COSMOS LTDASTRA PHARMA (U) LIMITEDCODEINE PHOSPHATE TABLETS BP 30CODEINE PHOSPHATE30MGCOSMOS LIMITED -RANGWA ROAD, OFF LUNGA LUNGA ROAD, INDUSTRIAL AREA KENYAORAL SOLID ORDINARY TABLETS1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER01/07/1998
1171NDA/MAL/HDP/1912MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDD-WORMALBENDAZOLE200MGTORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506INDIAORAL SOLID ORDINARY TABLETS1.0X2.0 TABLET BLISTER01/07/2008
1172NDA/MAL/HDP/1914RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDCHLORPHENIRAMINECHLORPHENIRAMINE4MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA UGANDAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER01/07/2003
1173NDA/MAL/HDP/1915HETERO LABS LTDAIVEEN (U) LIMITEDATAZANAVIR SULPHATE + RITONAVIRATAZANAVIR SULPHATE + RITONAVIR300 MG + 100 MGHETERO LABS LTD UNIT III-22-110 IDA JEEDIMETIA HYDERABAD ANDHRA PRADESH , HETERO LABS LTD (UNIT-V)-SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET CONTAINER07/01/13
1174NDA/MAL/HDP/1919GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDCANDIDERM CREAMBECLOMETASONE/CLOTRIMAZOLE/GENTAMYCIN0.025%W/W+1%W/W+0.1%W/WGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D INDIATOPICAL EXTERNAL CREAMS1.0X5.0 G TUBE,1.0X15.0 G TUBE01/07/1999
1175NDA/MAL/HDP/1920STRIDES ARCOLAB LTDROYAL PHARMA 2011 LIMITEDASCORBIC ACID TABLETASCORBIC ACID100MG STRIDES ARCO LAB LTD-K.R.S GARDENS SURAGAJAKKANAHALLI,INDLAWADI CROSS ANEKAL TALUK,BANGALORE INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER01/07/1997
1176NDA/MAL/HDP/1922IPCA LABORATORIES LIMITEDMEDVIN PHARMA LIMITEDAZIFAST-500AZITHROMYCIN500MG IPCA LABORATORIES LTD,PLOT NO. T-139 -SEJAVTA, RATLAM-457 002 (M.P.) INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X3.0 TABLET BLISTER01/07/2007
1177NDA/MAL/HDP/1923GALENTIC PHARMA (PVT)LTDNORVIK ENTERPRISES LIMITEDBETAMETHASONEBETAMETHASONE0.1%W/WGALENTIC PHARMA( INDIA ) PVT LTD-R-673,MIDC TTC RABALE THANE-BELAPUR ROAD,NAVI INDIATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE01/07/2005
1178NDA/MAL/HDP/1924ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDAMPICILLIN SODIUMAMPICILLIN SODIUM500MGCSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG)CO. LTD-NO. 88, YANGZI ROAD, SHIJIAZHUANG CITY, HEBEI PROVINCE(WORKSHOP 406 AND 407) CHINAPARENTERAL ORDINARY DRY VIALS1.0X50.0X500.0 MG VIAL01/07/2013
1179NDA/MAL/HDP/1925BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDG - ALFENAC- PACECLOFENAC + PARACETAMOL100MG + 500MGBLISS GVS PHARMA LTD-PLOT.NO 10,SURVEY NO 38/1,DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR, TAL: PALGHAR DIST.THANE, MAHARASHTRA-INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER01/07/2014
1180NDA/MAL/HDP/1927REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDINTAPLEX TABLETVITAMIN B COMPOUNDN/AREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA KENYAORAL SOLID ORDINARY TABLETS1.0X100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER07/01/97
1181NDA/MAL/HDP/1928STEDMAN PHARMACEUTICALS PVT. LTDVEERAM HEALTHCARE (U) LIMITEDNEUTRAFLUXALGINIC ACID + MAGNESIUM HYDROXIDE +ALUMINIUM HYDROXIDE + MAGNESIUM TRISILICATE + SIMETHICONE200MG + 250MG +250MG +250MG + 125MGSTEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2013
1182NDA/MAL/HDP/1929CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDATORVA 40ATORVASTATIN40MGCADILA HEALTH CARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER07/01/12
1183NDA/MAL/HDP/1931ASTRAZENECAMACNAUGHTON LIMITEDZOLADEX LAGOSERELIN ACETATE10.8MGASTRA ZENECA UK LIMITED-ASTRAZENECA UK LIMITED SILK ROAD BUSINESS PARK, MACCLES FIELD,CHESHIRE SK 10 2NA, UNITED KINGDOMPARENTERAL RETARD PRE-FILLED SYRINGES1.0X10.8 MG IMPLANT01/07/2010
1184NDA/MAL/HDP/1932ELYS CHEMICAL INDUSTRIES LTDVELVET PHARMA LIMITEDCANDISTAT CREAMCLOTRIMAZOLE1%W/WELYS CHEMICAL INDUSTRIES LIMITED-ROAD B’, OFF ENTERPRISE ROAD
PLOT NO. 209/8927 INDUSTRIAL AREA
KENYAORAL TOPICAL CREAMS1.0X20.0 G TUBE01/07/2001
1185NDA/MAL/HDP/1934RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDRENECHLOR SUSPENSIONCHLORAMPHENICOL125MG/5MLRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA UGANDAORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE01/07/2001
1186NDA/MAL/HDP/1935NABIQASIM INDUSTRIES (PVT) LTD.JEET PHARMACEUTICALS LIMITEDSULPHA KREAM-NSULPHANILAMIDE15%W/WNABIQASIM INDUSTRIES (PVT) LTD--17/24,KORANGI INDUSTRIAL AREA, KORANGI, KARACHI- PAKISTAN. PAKISTANTOPICAL EXTERNAL CREAMS1.0X1.0X80.0 G TUBE01/07/2006
1187NDA/MAL/HDP/1936GLAXO SMITH KLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDPIRITON EXPECTORANTCHLORPHENIRAMINE MALEATE + AMMONIUM CHLORIDEMULTINGREDIENTGLAXO WELLCOME (KENYA) LTD-KENYAKENYAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE07/01/97
1188NDA/MAL/HDP/1937AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDEFAVIRENZEFAVIRENZ600MGAUROBINDO PHARMA LIMITED (UNIT III) -AURO HOUSE, 313, BUCHUPALLY, QUTHUBULLAPAR(M), RR DISTRICT HYDERABAD-500090, ANDHERA PRADESH, INDIA. INDIAORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET CONTAINER01/07/2005
1189NDA/MAL/HDP/1940REMEDICA LTDGOODMAN INTERNATIONAL LTDCLOXACILLIN CAPSULESCLOXACILLIN SODIUM250MGREMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR CYPRUSORAL SOLID ORDINARY CAPSULES10.0X10.0 CAPSULE BLISTER01/07/2001
1190NDA/MAL/HDP/1941CADILA PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.RABELOC IVRABEPRAZOLE20MG/VIALCADILA PHARMACEUTICALS LIMITED-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA INDIAPARENTERAL ORDINARY VIALS1.0X5.0 ML VIAL01/07/2005
1191NDA/MAL/HDP/1942RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDAMCLORENAMPICILLIN + CLOXACILLIN250 MG + 250 MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA UGANDAORAL SOLID ORDINARY CAPSULES1.0X100.0 CAPSULE CONTAINER01/07/2009
1192NDA/MAL/HDP/1943MODI MUNDI PHARMA PVT LTDSURGIPHARM (U) LIMITEDNITROCONTIN 2.6NITROGLYCERIN (CONTROLLED RELEASE)2.6MGMODI MUNDIPHARMA (PVT) LTD-MEERUT - MUZAFFARNAGAR ROAD, MODIPURAM, UTTAR PRADESH ESTATE INDIAORAL SOLID RETARD TABLETS1.0X25.0 TABLET CONTAINER01/07/2009
1193NDA/MAL/HDP/1946WIN-MEDICARE LTDSURGIPHARM (U) LIMITEDSOLUDOL TABLETSDICLOFENAC SODIUM50MGWIN MEDICARE PVT LIMITED-MEERUT, MUZAFFARNAGER ROAD, MODIPURAM – 250110, UTTAR
PRADESH - INDIA
INDIAORAL SOLID ORDINARY SOLUBLE TABLETS10.0X10.0 TABLET STRIP01/07/1998
1194NDA/MAL/HDP/1948PFIZER LABORATORIES PTY LTDLABOREX UGANDA LIMITEDZITHROMAXAZITHROMYCIN DIHYDRATE500MGHAUPT PHARMA LATINA S.R.L LATINA-SS 156KM 47,600-04100,BORGO SAN,MICHELE PFIZER LABORATORIES (PTY) LTD;--SOUTH AFRICA SOUTH AFRICAORAL SOLID ORDINARY TABLETS1.0X3.0 TABLET BLISTER,1.0X2.0 TABLET BLISTER01/07/1998
1195NDA/MAL/HDP/1949MACLEODS PHARMACEUTICALS LTDS LTDNORVIK ENTERPRISES LIMITEDTRENAXA 500TRANEXAMIC ACID500MGMACLEODS PHARMACEUTICALS -PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT), INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X5.0X6.0 TABLET BLISTER01/07/2011
1196NDA/MAL/HDP/1951MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDCLOPI 75CLOPIDOGREL75MGMACLEODS PHARMACEUTICALS -PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT), INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET STRIP,3.0X10.0 TABLET STRIP01/07/2006
1197NDA/MAL/HDP/1952JOHNSON &JOHNSON (PTY) LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDNIZORALKETOCONAZOLE20MG/GSPECPHARM HOLDINGS- 15TH ROAD HALFWAY HOUSESOUTH AFRICATOPICAL EXTERNAL LIQUID SOAPS/WASHES1.0X80.0 ML BOTTLE01/07/1997
1198NDA/MAL/HDP/1953UNIQUE PHARMACEUTICALS LABORATORIESTATA UGANDA LIMITEDRANTAB-150RANITIDINE150MGUNIQUE PHARMACEUTICAL LABORATORIES (A DIV. OF J.B CHEMICALS & PHARMACEUTICALS LTD)--216-219 GIDC INDUSTRIAL AREA PANOLI 394 116 DIST BHARUCHINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/1997
1199NDA/MAL/HDP/1954: ALKEM LABORATORIES LIMITED?ABACUS PHARMA (AFRICA) LIMITEDRAPEED-20RABEPRAZOLE20MGALKEM LABORATORIES LTD .-VILLAGE THANA, BADDI, TEHSIL-NALAGARH, DISTT-SOLAN, (HP), INDIA-173205 INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET STRIP,1.0X1.0X10.0 TABLET STRIP01/07/2011
1200NDA/MAL/HDP/1955MILAN LABORATORIES LTDGITTOES PHARMACEUTICALS LIMITEDMILCILLINAMPICILLIN250MGMILAN LABORATORIES -PLOT NOS 63, 67 & 87, JAWAHAR CO-OP. INDUSTRIAL
ESTATE LTD., KAMOTHE, PANVEL (NAVI MUMBAI).
INDIAORAL SOLID ORDINARY CAPSULES1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER01/07/2005
1201NDA/MAL/HDP/1956MILAN LABORATORIES LTDGITTOES PHARMACEUTICALS LIMITEDMILOXYAMOXYCILLIN250MGMILAN LABORATORIES -PLOT NOS 63, 67 & 87, JAWAHAR CO-OP. INDUSTRIAL
ESTATE LTD., KAMOTHE, PANVEL (NAVI MUMBAI).
INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER01/07/2006
1202NDA/MAL/HDP/1957MILAN LABORATORIES LTDGITTOES PHARMACEUTICALS LIMITEDMILCILLINAMPICILLIN125MG/5MLMILAN LABORATORIES -PLOT NOS 63, 67 & 87, JAWAHAR CO-OP. INDUSTRIAL
ESTATE LTD., KAMOTHE, PANVEL (NAVI MUMBAI).
INDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE01/07/2005
1203NDA/MAL/HDP/1958MILAN LABORATORIES LTDGITTOES PHARMACEUTICALS LIMITEDMILOXYAMOXYCILLIN125MG/5MLMILAN LABORATORIES -PLOT NOS 63, 67 & 87, JAWAHAR CO-OP. INDUSTRIAL
ESTATE LTD., KAMOTHE, PANVEL (NAVI MUMBAI).
INDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE01/07/2005
1204NDA/MAL/HDP/1959MILAN LABERATORIES PVT LTDGITTOES PHARMACEUTICALS LIMITEDBETRIM 480CO-TRIMOXAZOLE480MGMILAN LABORATORIES -PLOT NOS 63, 67 & 87, JAWAHAR CO-OP. INDUSTRIAL
ESTATE LTD., KAMOTHE, PANVEL (NAVI MUMBAI).
INDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER01/07/2005
1205NDA/MAL/HDP/1960KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDDIFENACDICLOFENAC SODIUM50MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD -PLOT NO. M444B, STRETCHER ROAD, NTINDA, KAMPALA UGANDAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2003
1206NDA/MAL/HDP/1961TRIVENI FORMULATIONS LIMITEDAIVEEN (U) LIMITEDMUILTIZEBEXVITAMIN A + CHOLECALCIFEROL + THIAMINE + RIBOFLAVINE + PYRIDOXINE + NICOTINAMIDE2500 IU + 200IU + 1MG +1MG + 0.5MG +15MGTRIVENI FORMULATIONS LIMITED --PLOT NO 52-54,62-64 ALEAP INDUSTRIAL ESTATE SURAMPALLI (V) VIJAYAWADA A.P INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET STRIP01/07/2014
1207NDA/MAL/HDP/1962BETA HEALTHCARE UGANDA LIMITEDBETA HEALTHCARE UGANDA LIMITEDNIMBEXCISATRACURIUM BESYLATE2MG/MLGLAXOSMITHKLINE S.P.A -STRADA PROVINCIALE ASOLANA 9ITALYPARENTERAL ORDINARY VIALS2.5 ML VIAL,1.0X10.0 ML VIAL01/07/1997
1208NDA/MAL/HDP/1963MILAN LABERATORIES PVT LTDGITTOES PHARMACEUTICALS LIMITEDDICLOFENAC GELDICLOFENAC1%W/WMILAN LABORATORIES -PLOT NOS 63, 67 & 87, JAWAHAR CO-OP. INDUSTRIAL
ESTATE LTD., KAMOTHE, PANVEL (NAVI MUMBAI).
INDIATOPICAL EXTERNAL GELS AND SOLS1.0X35.0 G TUBE01/07/2006
1209NDA/MAL/HDP/1964MILAN LABORATORIES LTDGITTOES PHARMACEUTICALS LIMITEDCLONEXCLOTRIMAZOLE1%W/WMILAN LABORATORIES -PLOT NOS 63, 67 & 87, JAWAHAR CO-OP. INDUSTRIAL
ESTATE LTD., KAMOTHE, PANVEL (NAVI MUMBAI).
INDIATOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE01/07/2007
1210NDA/MAL/HDP/1966MACK BROWN PHARMACEUTICALS PVT LIMITEDSHURIK LTDPARACINPARACETAMOL500MGTORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506INDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER01/07/2005
1211NDA/MAL/HDP/1969NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDVOLTAREN SR 75MGDICLOFENAC SODIUM75MGNOVARTIS PHARMA SPA, TORRE ANNUNZIATA ITALY-NA ITALYORAL SOLID RETARD TABLETS1.0X30.0 TABLET CONTAINER01/07/1997
1212NDA/MAL/HDP/1970MACK BROWN PHARMACEUTICALS PVT LIMITEDSHURIK LTDCETRAMACCETIRIZINE10MGTORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2005
1213NDA/MAL/HDP/1971AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOMPICLOX ORAL SUSPENSIONAMPICILLIN + CLOXACILLIN125 MG/5ML + 125 MG/5MLMILAN LABORATORIES (INDIA ) PVT LTD-PLOT NO.63-67 & 87,JAWAHAR CO.OP.INDUSTRIAL ESTATE LTD KAMOTHE,PANVEL DIST. THANE,MAHARASTRA-410209,INDIA INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE01/07/1998
1214NDA/MAL/HDP/1974SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDCEFROTILCEFUROXIME AXETIL500MGSAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER01/07/2013
1215NDA/MAL/HDP/1975LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDBET-CODERM NBETAMETHASONE + NEOMYCIN0.1 W/W + 0.5 W/WLINCOLN PHARMACEUTICALS LTD-10, 11, 13, TRIMUL ESTATE KHATRAJ, NEAR KHATRAJ, CHOKADI , KHATRAJ-382721, GHANDINAGAR GUJARAT, INDIA
INDIATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE01/07/2007
1216NDA/MAL/HDP/1977UNICHEM LABORATORIES LTDEUROPA HEALTHCARE (U) LTDLOSA-HLOSARTAN + HYDROCHLOROTHIAZIDE50MG + 12.5MGUNICHEM LABORATORIES LIMITED-UNICHEM LABORATORIES LIMITED. UNIT II, VILLAGE BHATAULI KALAN, BADDI, DIST. SOLAN PIN CODE 173 205, HIMACHAL PRADESH, INDIA

INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER07/01/11
1217NDA/MAL/HDP/1984ELI-LILLY (SUISSE) SALABOREX UGANDA LIMITEDCIALISTADALAFIL20MGLILLY SA, AVDA DE LA INDUSTRIA-LILLY SA, AVDA DE LA INDUSTRIA, 30 28108 ALCOBENDAS - MADRID SPAINORAL SOLID ORDINARY TABLETS2.0X2.0 TABLET BLISTER01/07/2004
1218NDA/MAL/HDP/1985GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDPROXIMEXA ORAL SUSPENSION 250MG/5MLCEFUROXIME AXETIL250MG/5MLGLAXOSMITHKLINE UK LTD-HARMIRE RD BARNARD CASTLE DURHAM, DL12DT UNITED UNITED KINGDOMORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X1.0X50.0 ML BOTTLE01/07/2007
1219NDA/MAL/HDP/1988KUNMING PHARMACEUTICALS CORPSINO AFRICA MEDICINES & HEALTH LTDARTEMEDINE INJECTIONARTEMETHER80MG/MLKUNMING PHARMACEUTICAL CORP.-QIGONGLI, WEST SURBURB, KUNMING 650106 - YUNNAM PROVINCE, P.R. CHINA CHINAPARENTERAL ORDINARY I M AMPOULES1.0X0.5 ML AMPOULE01/07/1999
1220NDA/MAL/HDP/1989FERRER INTERNACIONAL S.ALABOREX UGANDA LIMITEDDERMOFIXSERTACONAZOLE NITRATE2%W/WFERRER INTERNACIONAL,S.A.-GRAN VIA CARLOS III 94 BARCELONA (ESPANA /SPAIN) SPAINTOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE07/01/14
1221NDA/MAL/HDP/1990UNICHEM LABORATORIES LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDTAGERA FORTESECNIDAZOLE1GUNICHEM LABORATORIES LTD---C31 & 32 INDUSTRIAL AREAINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X1.0X2.0 TABLET BLISTER01/07/2005
1222NDA/MAL/HDP/1994UNIQUE PHARMACEUTICALS LABORATORIESTATA UGANDA LIMITEDPANUM 40PANTOPRAZOLE40MGJ.B. CHEMICALS AND PHARMACEUTICALS LTD .-128/1, GIDC, ANKLESHWAR 393 002, GUJARAT INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2007
1223NDA/MAL/HDP/1997AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDTENA-100ATENOLOL100MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER01/07/2011
1224NDA/MAL/HDP/1998M.J.BIOPHARM PVT LTDTATA UGANDA LIMITEDTEICO 500CEFEPIME500MGM.J BIOPHARM PVT LTD --L-7 MIDC INDUSTRIAL AREA, DIST . RAIGAD , TALOJA , NAVI MUMBAI INDIAPARENTERAL ORDINARY DRY VIALS1.0X500.0 MG VIAL01/07/2013
1225NDA/MAL/HDP/1999TORRENT PHARAMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.CARBATOL 200CARBAMAZEPINE200MGTORRENT PHARMACEUTICALS LTD-INDRAD-382721, TAL KADI, AHMEDABAD, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,2.0X5.0X10.0 TABLET BLISTER01/07/2000
1226NDA/MAL/HDP/2000TORRENT PHARAMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.CALCIGARD RETARDNIFEDIPINE(SR)20MGTORRENT PHARMACEUTICALS LTD-INDRAD-382721, TAL KADI, AHMEDABAD, INDIA INDIAORAL SOLID RETARD TABLETS10.0X10.0 TABLET BLISTER01/07/2000
1227NDA/MAL/HDP/2003GLAXO SMITHKLINE LTD(ITALY)UNITED HEALTHCARE DISTRIBUTORS LTDPROTEDEX 1GCEFTRIAXONE1GGLAXOSMITHKLINE LTD MANUFACTURING SPA-VERONAITALYPARENTERAL ORDINARY DRY VIALS1.0X1.0 G VIAL01/07/2014
1228NDA/MAL/HDP/2004MEDLEY PHARMACEUTICALS LTDMEDVIN PHARMA LIMITEDR.B.TONEFERROUS GLUCONATE + VITAMIN C + VITAMIN B12 + VITAMIN B1 + VITAMIN B2 + VITAMIN B6 + CALCIUM PANTOTHENATE + VITAMIN B3 + FOLIC ACID + DIBASIC CA PO4 + ZINC SULPHATE200MG + 38MG + 4MCG + 3MG + 2.5MG + 1MG + 2.5MG + 1MG + 2.5MG + 23MG + 0.5MG + 100MG + 33MGMEDLEY PHARMACEUTICALS LTD-PLOT NO.18 AND 19, SURVEY NO.378/8 & 379/2, KEBRA INDUSTRIAL ESTATE, KACHIGAM, DAMAN-396210 INDIA INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X15.0 CAPSULE BLISTER01/07/2008
1229NDA/MAL/HDP/2005AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDKAMAGRA-100SILDENAFIL CITRATE100MGAJANTA PHARMA LIMITED PAITHAN-MANUFACTURING UNIT B-4/5/6 MIDC PAITHAN DISTRICT AURANGABAD 431 148 MAHARASTRA STATE INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X1.0X4.0 TABLET BLISTER01/07/2005
1230NDA/MAL/HDP/2007AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDB-COX TABLETSVITAMIN B COMPLEXBCP FORMULAAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER01/07/2001
1231NDA/MAL/HDP/2008GLENMARK PHARMACUTICALS LTDSTAR PHARMACEUTICALS LTDCANDID -B- CREAMCLOTRIMAZOLE + BECLOMETASONE DIPROPRIONATE CREAM1%W/W + 0.025%W/WGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D INDIATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE01/07/2004
1232NDA/MAL/HDP/2009COSMOS LTDASTRA PHARMA (U) LIMITEDZITHROXAZITHROMYCIN200MG/5MLCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI KENYAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X15.0 ML BOTTLE,1.0X30.0 ML BOTTLE01/07/2010
1233NDA/MAL/HDP/2011HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDSIFE 50SILDENAFIL CITRATE50MGHETERO LABS LTD. UNIT (V) .-S.N0.439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE), JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA. INDIAORAL SOLID ORDINARY TABLETS1.0X4.0 TABLET BLISTER01/07/2013
1234NDA/MAL/HDP/2012GLENMARK PHARMACUTICALS LTDSTAR PHARMACEUTICALS LTDCANDID -B- LOTIONCLOTRIMAZOLE + BECLOMETHASONE DIPROPIONATE1%W/V + 0.025%W/VGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D INDIATOPICAL EXTERNAL LOTIONS1.0X15.0 ML BOTTLE01/07/2004
1235NDA/MAL/HDP/2014SK AGE EXPORTSABACUS PHARMA (AFRICA) LIMITEDCANI-MAKSCLOTRIMAZOLE1%W/W S KANT HEALTHCARE LTD-1802-1805 GIDC OHASE II VAPS-396195, GUJARAT, INDIA INDIATOPICAL EXTERNAL CREAMS1.0X1.0X15.0 G TUBE07/01/09
1236NDA/MAL/HDP/2016GLENMARK PHARMACUTICALS LTDSTAR PHARMACEUTICALS LTDCANDID CREAMCLOTRIMAZOLE1%W/WGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D INDIATOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE01/07/2000
1237NDA/MAL/HDP/2018CENTAUR PHARMACEUTICALS LTDGITTOES PHARMACEUTICALS LIMITEDORAXIN SYRUPCYPROHEPTADINE+TRICHOLINE CITRATE2MG+275MGCENTAUR PHARMACEUTICALS LTD,--KARASWADA MAPUSA GOA INDIAORAL LIQUID ORDINARY SYRUPS1.0X200.0 ML BOTTLE,1.0X100.0 ML BOTTLE01/07/1997
1238NDA/MAL/HDP/2019AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOHALHALOPERIDOL10MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2011
1239NDA/MAL/HDP/2020KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDQUINEQUININE SULPHATE300MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALAUGANDAORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X500.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,1.0X250.0 TABLET CONTAINER01/07/1997
1240NDA/MAL/HDP/2021PHARCO PHARMACEUTICALSWIDE SPECTRUM ENTERPRISES (U) LIMITEDPREGVIT ZINCMULTIVITAMIN/MINERALSMULT-INGREDIENTPHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT.
P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT
EGYPTORAL SOLID ORDINARY CAPSULES1.0X12.0X2.0 CAPSULE BLISTER01/07/2000
1241NDA/MAL/HDP/2022MACK BROWN PHARMACEUTICALS PVT LIMITEDSHURIK LTDTORACTINCYPROHEPTADINE2MG/5MLTORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506INDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE01/07/1997
1242NDA/MAL/HDP/2024TORRENT PHARMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.NEXPRO - 40ESOMEPRAZOLE MAGNESIUM TABLET40MGTORRENT PHARMACEUTICALS LTD-INDRAD-382 721, DIST.MEHSANA,INDIA.AT:VILL.MANAKPUR,TEH.NALAGARH,DIST.SOLAN(H.P.) INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET STRIP01/07/2004
1243NDA/MAL/HDP/2025REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDFERRO-B COMPLEX SYRUPMULTI-INGREDIENTMULTI-INGREDIENTREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA KENYAORAL LIQUID ORDINARY SYRUPS1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE01/07/1997
1244NDA/MAL/HDP/2026BROOKES PHARMACEUTICAL LABORATORIES LHARLEYS UGANDA LIMITEDCORAM 10MGAMLODIPINE BESYLATE10MGBROOKES PHARMACEUTICALS LABORATORIES (PAKISTAN) LTD-PLOT 58 SECTOR 15 KORANGI
INDUSTRIAL AREA, KARACHI-PAKISTAN
PAKISTANORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER01/07/2009
1245NDA/MAL/HDP/2027UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTDWIDE SPECTRUM ENTERPRISES (U) LIMITEDCO-ANGINET 160/12.5MGVALSARTAN + HYDROCHLOROTHIAZIDE160MG + 12.5MGUNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD-P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSINGJORDANORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2013
1246NDA/MAL/HDP/2028SEARLE PAKISTAN LIMITEDHEALTHCARE LTD.SELANZ - SRLANSOPRAZOLE30MGSEARLE PAKISTAN LIMITED-PLOT 35KM, MULTAN ROAD, LAHORE - PAKISTAN PAKISTANORAL SOLID ORDINARY CAPSULES1.0X1.0X7.0 CAPSULE BLISTER01/07/2005
1247NDA/MAL/HDP/2031AGOG PHARMA LTD.GITTOES PHARMACEUTICALS LIMITEDAGOZID TABLETSISONIAZID100MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER01/07/2004
1248NDA/MAL/HDP/2033MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDANGIZAAR-50LOSARTAN POTASSIUM50MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET STRIP01/07/2009
1249NDA/MAL/HDP/2035KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDNEOSIDARSULPHADOXINE + PYRIMETHAMINE500MG + 25MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALAUGANDAORAL SOLID ORDINARY TABLETS1.0X25.0X3.0 TABLET BLISTER,1.0X50.0X3.0 TABLET BLISTER01/07/2004
1250NDA/MAL/HDP/2036ELI-LILLY (SUISSE) SALABOREX UGANDA LIMITEDHUMULIN REGULARHUMAN INSULIN100IUELI LILLY & COMPANY-LILLY TECHNOLOGY CENTER, 1555 S HARDING, INDIANAPOLIS, INDIANA, 46221 LILLY FRANCE SA-FRANCE FRANCEPARENTERAL ORDINARY S C VIALS1.0X10.0 ML VIAL,1.0X5.0X3.0 ML CARTRIDGE01/07/1998
1251NDA/MAL/HDP/2037MERCK SHARP & DOHME BVPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDSTOCRIN 50EFAVIRENZ50MG ZHEJIANG HUAHAI PHARMACEUTICAL CO. LTD-XUNQIAO, LINHAI, ZHEJIANG PROVINCE 317024 PEOPLES’ REPUBLIC OF CHINA MERCK SHARP & DOHME.-WAADERWAG 39, POSTBUS 581. 2003 PC HAARLEM NETHERLANDSORAL SOLID ORDINARY FILM-COATED TABLETS1.0X30.0 TABLET BOTTLE01/07/2008
1252NDA/MAL/HDP/2039GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDRANITIDINE INJECTION USPRANITIDINE25MG/MLNINGBO DAHONGYING PHARMACEUTICALS LTD- NO. 396 MINCHINAPARENTERAL ORDINARY AMPOULES1.0X1.0X10.0X2.0 ML AMPOULE01/07/2011
1253NDA/MAL/HDP/2040AJANTA PHARMA LIMITEDABACUS PHARMA (AFRICA) LIMITEDARTEFAN 20/120ARTEMETHER + LUMEFANTRINE20 MG + 120 MGAJANTA PHARMA LIMITED PAITHAN-MANUFACTURING UNIT B-4/5/6 MIDC PAITHAN DISTRICT AURANGABAD 431 148 MAHARASTRA STATE INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X30.0X12.0 TABLET BLISTER,1.0X3.0X8.0 TABLET BLISTER,1.0X30.0X24.0 TABLET BLISTER,1.0X30.0X18.0 TABLET BLISTER,1.0X30.0X6.0 TABLET BLISTER,1.0X1.0X6.0 TABLET BLISTER,1.0X1.0X12.0 TABLET BLISTER,1.0X1.0X24.0 TABLET BLISTER,1.0X1.0X18.0 TABLET BLISTER,1.0X1.0X24.0 TABLET BLISTER01/07/2006
1254NDA/MAL/HDP/2041IDAKIMSY MEDS LTDOXYTOCINOXYTOCIN10IUGLAND PHARMA LIMITTED 143-148-D P PALLY, QUTHUBULLAPUL MANDAL, RANDA REDDY DIST, HYBERABAD, IN-500 043, INDIA INDIAPARENTERAL ORDINARY AMPOULES1.0X10.0X1.0 ML AMPOULE01/07/2005
1255NDA/MAL/HDP/2042NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDBURNCURESILVER SULFADIAZINE1%W/WNEM LABORATORIES PVT LTD-133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAIINDIATOPICAL EXTERNAL CREAMS1.0X200.0 G TUBE,1.0X15.0 G TUBE01/07/1997
1256NDA/MAL/HDP/2043COSMOS LTDASTRA PHARMA (U) LIMITEDDIASTOP TABLETSATTAPULGITE/ ALUMINIUM HYDROXIDEN/ACOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI KENYAORAL SOLID ORDINARY TABLETS1.0X25.0X4.0 TABLET STRIP01/07/1998
1257NDA/MAL/HDP/2044ELYS CHEMICAL INDUSTRIES LTDVELVET PHARMA LIMITEDCLOXACILLIN CAPSULESCLOXACILLIN250MGELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBI KENYAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER01/07/1997
1258NDA/MAL/HDP/2045ELDA INTERNATIONAL DMCCREDDYS PHARMA LIMITEDBUPICANBUPIVACAINE0.5% W/VCLARIS INJECTABLES LIMITED---CHACHARWADI VASANA 382 213 AHMEDABAD GUJARATINDIAPARENTERAL ORDINARY VIALS1.0X20.0 ML VIAL07/01/06
1259NDA/MAL/HDP/2046COSMOS LTDASTRA PHARMA (U) LIMITEDLORHISTINALORATADINE10MGCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI KENYAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2005
1260NDA/MAL/HDP/2047MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDRITONAVIRRITONAVIR100MGMYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE
INDIAORAL SOLID ORDINARY TABLETS1.0X120.0 TABLET CONTAINER,1.0X30.0 TABLET BOTTLE01/07/2011
1261NDA/MAL/HDP/2049WOCKHARDT LTDSTAR PHARMACEUTICALS LTDKEFSTAR-500CEFUROXIME AXETIL500MGSANCE LABORATORIES PVT LTD-VI/51B, P.B. NO.2, KOZHUVANAL, PALA, KOTTAYAM DISTRICT-686573, KERALA, INDIA. INDIAORAL SOLID ORDINARY TABLETS1.0X1.0X4.0 TABLET STRIP,1.0X1.0X10.0 TABLET BLISTER01/07/2005
1262NDA/MAL/HDP/2050NORVATIS PHARMA AG- SWITZERLANDLABOREX UGANDA LIMITEDISOPTO CARPINE 2%PILOCARPINE2%W/VALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUM BELGIUMOPHTHALMIC DROPS1.0X15.0 ML BOTTLE07/01/97
1263NDA/MAL/HDP/2051GLAXO SMITH KLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDPIRITON TABLETSCHLORPHENIRAMINE MALEATE4MGGLAXO WELLCOME (KENYA) LTD-KENYAKENYAORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER07/01/97
1264NDA/MAL/HDP/2053EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDASOMEX-5AMLODIPINE BESILATE5MGEMCURE PHARMACEUTICALS LTD -LANE NO.3 PHASE II,SIDCO INDUSTRIAL COMPLEX,BARI-BRAHMANA JAMMU 181 133, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X5.0X10.0 TABLET BLISTER07/01/05
1265NDA/MAL/HDP/2055GUILIN PHARMACEUTICALS CO.LTDSTAR PHARMACEUTICALS LTDARTESUNARTESUNATE120MGGUILIN PHARMACEUTICAL CO.,LTD-NO 43 QILIDIAN ROAD GUILIN 541002, GUANGXI CHINAPARENTERAL ORDINARY DRY VIALS1.0X120.0 MG VIAL + 1 *2 ML AMPOULE OF 5% SODIUM BICARBONATE SOLUTION + 1*10 ML AMPOULE OF 0.9% SODIUM CHLORIDE01/07/2011
1266NDA/MAL/HDP/2056WOCKHARDT LTDSTAR PHARMACEUTICALS LTDBRO-ZEDEXTERBUTALINE SULPHATE +BROMHEXINE HYDROCHLORIDE+GUAIPHENESIN+MENTHOL1.25MG+ 4 MG+50 MG+2.5 MG/5 MLWOCKHARDT LIMITED --PLOT 57 VILLAGE KUNJHAL, JHAMAJRI, BAROTIWALA, BADDI, TEHSIL-NALAGARH, DISTRICT SOLAN, 174103 HIMACHAL PRADESH, INDIA INDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE01/07/1997
1267NDA/MAL/HDP/2058MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDQUININE SULPHATEQUININE SULPHATE300MGMACLEODS PHARMACEUTICALS -PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT), INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER01/07/2006
1268NDA/MAL/HDP/2063BAYER PHARMA AGSURGIPHARM (U) LIMITEDMICROGYNON FELEVONORGESTREL / ETHINYLESTRADIOL.0.15MG / 0.03MGBAYER PHARMA A.G-MULLERSTRASSE 178, 13353 BERLIN, GERMANY GERMANYORAL SOLID ORDINARY TABLETS1.0X1.0X28.0 TABLET BLISTER01/07/1997
1269NDA/MAL/HDP/2066REMEDICA LTDGOODMAN INTERNATIONAL LTDMETHOTREXATEMETHOTREXATE2.5MGREMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR CYPRUSORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2005
1270NDA/MAL/HDP/2067UNICHEM LABORATORIES LTDEUROPA HEALTHCARE (U) LTDZYNCETCETIRIZINE DIHYDROCHLORIDE10MGUNICHEM LABORATORIES LIMITED UNIT II-VILLAGE BHATAULI KALAN BADDI DIST SOLAN HIMACHAL PRADESH 173 205INDIAORAL SOLID ORDINARY TABLETS1.0X4.0X5.0X10.0 TABLET BLISTER07/01/99
1271NDA/MAL/HDP/2068UNICHEM LABORATORIES LTDEUROPA HEALTHCARE (U) LTDDOMADOLTRAMADOL HYDROCHLORIDE50MGUNICHEM LABORATORIES LIMITED UNIT II-VILLAGE BHATAULI KALAN BADDI DIST SOLAN HIMACHAL PRADESH 173 205INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER07/01/99
1272NDA/MAL/HDP/2069SK AGE EXPORTSABACUS PHARMA (AFRICA) LIMITEDSK DERMBETAMETHASONE + CLOTRIMOXAZOLE + GENTAMYCIN0.05%W/W + 1%W/W + 0.1%W/W S KANT HEALTHCARE LTD-PLOT NO. 1802-1805, G.I.D.C. PHASE III, VAPI 396 195. GUJARAT. INDIATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE,1.0X30.0 G TUBE01/07/2010
1273NDA/MAL/HDP/2070BAYER PHARMA AGSURGIPHARM (U) LIMITEDMIRENALEVONORGESTREL52MGBAYER OY-PANSIONATE 47 20210 TURKU FINLANDFINLANDPARENTERAL RETARD IMPLANTS1.0X1.0 IMPLANT CARTON01/07/2009
1274NDA/MAL/HDP/2071CADILA PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.CEFAMOR DRY SYRUPCEFALEXIN125MG/5MLCADILA PHARMACEUTICALS LIMITED-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE01/07/2000
1275NDA/MAL/HDP/2073SERUM INSTITUTE OF INDIA LTD.NORVIK ENTERPRISES LIMITEDSII MEASLES VACCINE LIVE ATTENUATED(FREEZE-DRIED)MEASLES VIRUSNOT LESS THAN 1000CCID50/ DOSESERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIA INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0 DOSE VIAL + 0.5ML AMPOULE OF STERILE WATER FOR INJECTION,1.0X10.0 DOSE VIAL + 5ML AMPOULE OF STERILE WATER FOR INJECTION01/07/1997
1276NDA/MAL/HDP/2074AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOXIN ORAL SUSPENSIONAMOXYCILLIN TRIHYDRATE125MG/5MLMILAN LABORATORIES (INDIA ) PVT LTD-PLOT NO 63/67/87 J.C.I.E LTD KAMOTHE PANVER, NAVI MUMBAI,INDIA INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE01/07/1998
1277NDA/MAL/HDP/2075AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOPREDPREDNISOLONE5MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER01/07/2006
1278NDA/MAL/HDP/2076AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOMIDEFUROSEMIDE40MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER01/07/2006
1279NDA/MAL/HDP/2077ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDAMBRODILAMBROXOL HYDROCHLORIDE30MG/5MLARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO.II,MANDIDEEEP PRADESH INDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE01/07/2007
1280NDA/MAL/HDP/2078LEBEN LABORATORIES PVT LTDANDYCO PHARMACY (UGANDA) LTDALCLOX SYRUPCLOXACILLIN SODIUM125MG/5MLLEBEN LAB PVT LTD-L4 PHASE 111 MIDCS AKOLA 444104 MAHARASTRA INDIAINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE01/07/2007
1281NDA/MAL/HDP/2079GALENTIC PHARMA (PVT)LTDNORVIK ENTERPRISES LIMITEDNETRAVIRACICLOVIR5%W/WGALENTIC PHARMA PVT. LIMITED-R-673, TTC MIDC, RUBALE, THANE, INDIA INDIATOPICAL EXTERNAL CREAMS1.0X5.0 G TUBE01/07/2005
1282NDA/MAL/HDP/2080GALENTIC PHARMA( INDIA)PVT LTDNORVIK ENTERPRISES LIMITEDBETAMETHASONE VALERATEBETAMETHASONE VALERATE0.1%W/VGALENTIC PHARMA PVT. LIMITED-R-673, TTC MIDC, RUBALE, THANE BELAPURNAVI MUMBAI 400 701
INDIA
INDIATOPICAL EXTERNAL OINTMENTS1.0X15.0 G TUBE,1.0X30.0 G TUBE07/01/09
1283NDA/MAL/HDP/2081IVEE INFUSIONS EPZ LTDASTRA PHARMA (U) LIMITEDCOMPOUND SODIUM LACTATESODIUM LACTATE+SODIUM CHLORIDE+POTASSIUM CHLORIDE+ CALCIUM CHLORIDE DIHYDRATE0.32G+0.6G+0.04+0.027/100MLIVEE INFUSION EPZ LTD-ATHI RIVER EXPORT PROCESSING ZONE LR NO. 18474184KENYAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X500.0 ML BOTTLE01/07/2016
1284NDA/MAL/HDP/2083BIOLOGICAL E. LTDGITTOES PHARMACEUTICALS LIMITEDBEVACPURIFIED HEPATITIS B SURFACE ANTIGEN20MCGBIOLOGICAL E LTD-PLOT NO.1, S.P BIOTECHNOLOGY PARK, PHASE II KOLTHER (V), SHAMEERPET(M), RANGA REDDY(DIST), ANDHRA PRADESH, INDIA 500078 INDIAPARENTERAL ORDINARY VIALS1.0X35.0X1.0 ML VIAL (1 DOSE VIAL),1.0X24.0X10.0 ML VIAL (10 DOSE VIAL)07/01/15
1285NDA/MAL/HDP/2086ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDBENDASALBENDAZOLE200MGASTRA LIFE CARE(INDIA) PVT LTD-57/P, POJODA, SARKEJ BAVLA HIGHWAY RAJODA AHMEDABAD 382220, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X1.0X2.0 TABLET STRIP01/07/2011
1286NDA/MAL/HDP/2087ABBVIE LOGISTICS BVMEDICAL ACCESS (UGANDA) LIMITEDNORVIRRITONAVIR100MGABBVIE DEUTSCHLAND GMBH & CO. KG.-KNOLLSTASSE 50, D-67061, LUDWIGSHAFEN, GERMANY. GERMANYORAL SOLID ORDINARY TABLETS1.0X60.0 TABLET BOTTLE07/01/13
1287NDA/MAL/HDP/2089HOVID BHDUNITED HEALTHCARE DISTRIBUTORS LTDDIABETMIN XR 500MGMETFORMIN HCL EXTENDED RELEASE500MGHOVID BHD-LOT 56442, 7.5 MILE JALAN IPOH/CHEMO 31200 CHEMOR, PERAK MALAYSIA MALAYSIAORAL SOLID ORDINARY OTHER COATED TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2013
1288NDA/MAL/HDP/2090RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDCIPRORENCIPROFLOXACIN500MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA UGANDAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2005
1289NDA/MAL/HDP/2091KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDCAMSTONCLOTRIMAZOLE1%W/WKPI ( KAMPALA PHARMACEUTICAL INDUSTIRES LTD-PLOT M444 B STRETCHER ROAD NTINDAUGANDATOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE01/07/2001
1290NDA/MAL/HDP/2092CIPLA LTDQUALITY CHEMICALS LTD - HUMANDUOVIR-NLAMIVUDINE + ZIDOVUDINE + NEVIRAPINE150MG + 300MG + 200MGCIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA INDIAORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET BOTTLE,1.0X60.0 TABLET BOTTLE01/07/2004
1291NDA/MAL/HDP/2093CADILA PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.TRIGAN-D TABLETPARACETAMOL + DICYCLOMINE500MG + 20MGCADILA PHARMACEUTICALS LIMITED-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA INDIAORAL SOLID ORDINARY TABLETS10.0X10.0 TABLET STRIP01/07/1999
1292NDA/MAL/HDP/2094MICRO LABS LTDLABOREX UGANDA LIMITEDLEVOBACT-750LEVOFLOXACIN HEMIHYDRATE750MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X10.0 TABLET BLISTER01/07/2010
1293NDA/MAL/HDP/2095AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOMOLPARACETAMOL100MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER01/07/2010
1294NDA/MAL/HDP/2097LEBEN LABORATORIES PVT LTDANDYCO PHARMACY (UGANDA) LTDALCLOXCLOXACILLIN250MGLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL SOLID ORDINARY CAPSULES1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER01/07/2011
1295NDA/MAL/HDP/2098AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGO QUININEQUININE SULPHATE300MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER01/07/2006
1296NDA/MAL/HDP/2100MYLAN LABS LTDNORVIK ENTERPRISES LIMITEDORALCON - FLEVONORGESTREL & ETHINYLESTRADIOL+ FERROUS FUMARATE0.15MG + 0.03MG + 75MGMYLAN LABORATORIES LIMITED.--PLOT NO. 1606-1609, SARIGAM INDUSTRIAL AREA, GIDC, SARIGAM, TAL-UMERGAM, DIST VALSAD, 396155, GUJARAT, INDIA. MYLAN LABORATORIES LIMITED..-PLOT NO.20 & 21, PHARMEZ, SARKHEJ-BAVLA NATIONAL HIGHWAY NO. 08A, NEAR VILLAGE MATODA, TAL-SANAND, AHMEDABAD, GUJARAT, INDIA 382213 INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X28.0 TABLET BLISTER01/07/2007
1297NDA/MAL/HDP/2101COSMOS LTDASTRA PHARMA (U) LIMITEDCARDISPRINACETYL SALICYLIC ACID75MGCOSMOS LIMITED-RANGWE ROAD, OFF LUNGA ROAD - INDUSTRIAL AREA NAROBI KENYAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X14.0 TABLET BLISTER01/07/2010
1298NDA/MAL/HDP/2102MEDREICH PLCLABOREX UGANDA LIMITEDFLEMING 625AMOXYCILLIN + CLAVULANATE POTASSIUM500 MG + 125 MGMEDREICH LIMITED –UNIT I-12TH MILE, OLD MADRAS ROAD, VIRGONAGAR
BANGALORE-560 049, INDIA
INDIAORAL SOLID ORDINARY TABLETS1.0X2.0X7.0 TABLET BLISTER01/07/2006
1299NDA/MAL/HDP/2103MEDREICH PLCLABOREX UGANDA LIMITEDFLEMING 1000 TABAMOXYCILLIN + CLAVULANATE POTASSIUM875 MG + 125 MGMEDREICH LIMITED –UNIT I-12TH MILE, OLD MADRAS ROAD, VIRGONAGAR
BANGALORE-560 049, INDIA
INDIAORAL SOLID ORDINARY TABLETS1.0X2.0X7.0 TABLET BLISTER01/07/2006
1300NDA/MAL/HDP/2104MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDLAMIVUDINE/NEVIRAPINE /ZIDOVUDINE DISPERSIBLE TABLETSLAMIVUDINE + NEVIRAPINE + ZIDOVUDINE30MG + 50MG + 60MGMYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE
INDIAORAL SOLID ORDINARY SOLUBLE TABLETS1.0X60.0 TABLET BOTTLE01/07/2009
1301NDA/MAL/HDP/2105MEDREICH PLCLABOREX UGANDA LIMITEDFLEMING 156MG/5MLAMOXYCILLIN + CLAVULANATE POTASSIUM125 MG + 31.5 MG/5 MLMEDREICH LIMITED –UNIT I-12TH MILE, OLD MADRAS ROAD, VIRGONAGAR
BANGALORE-560 049, INDIA
INDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE01/07/2006
1302NDA/MAL/HDP/2108ELYS CHEMICAL INDUSTRIES LTDVELVET PHARMA LIMITEDELYMOX CAPSULES 250MGAMOXYCILLIN250MGELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBI KENYAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER01/07/1997
1303NDA/MAL/HDP/2111HETERO LABS LTDAIVEEN (U) LIMITEDLOPINAVIR / RITONAVIRLOPINAVIR / RITONAVIR200MG /50MGHETERO LABS LTD. UNIT (V) .-S.N0.439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE), JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA. HETERO LABS LTD-22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESH INDIAORAL SOLID ORDINARY TABLETS1.0X120.0 TABLET CONTAINER01/07/2011
1304NDA/MAL/HDP/2112MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDLOPINAVIR + RITONAVIRLOPINAVIR + RITONAVIR200MG + 50MGMYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE
INDIAORAL SOLID ORDINARY TABLETS1.0X120.0 TABLET CONTAINER01/07/2008
1305NDA/MAL/HDP/2114AXA PARENTERALS LTDGITTOES PHARMACEUTICALS LIMITEDAXA-LEVOLEVOFLOXACIN HEMIHYDRATE500MG/100MLAXA PARENTERAL LIMITED-PLOT NO.936,937&939,
VILL. KISHANPUR, JAMALPUR,ROORKEE 247667, DISTT. HARIDWAR
(UTTARAKHAND) INDIA.
INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X100.0 ML VIAL01/07/2015
1306NDA/MAL/HDP/2115ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDASTRIMCO-TRIMOXAZOLE480MGASTRA LIFE CARE (INDIA) PVT LIMITED-57/P RAJODA
382220 BAVIA
AHMEDABAD INDIA
INDIAORAL SOLID ORDINARY TABLETS10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER01/07/1997
1307NDA/MAL/HDP/2116MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDAMLOVAS-10AMLODIPINE BESILATE10MGMACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET STRIP01/07/2005
1308NDA/MAL/HDP/2118AVENTIS PHARMA (PTY) LTD SOUTH AFRICALABOREX UGANDA LIMITEDRIFAFOURE E-275RIFAMPICIN+ISONIAZID+PYRAZINAMIDE+ETHAMBUTOL150MG+75MG+400MG+275MGAVENTIS PHARMA-AVENTIS PHARMA, 315 WALTLOO ROAD, SILVERTON 0127 PRETORIA SOUTH AFRICAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X4.0X20.0 TABLET BLISTER01/07/2005
1309NDA/MAL/HDP/2120ALKEM LABORATORIES LIMITEDABACUS PHARMA (AFRICA) LIMITEDMEGAPIMECEFEPIME1GALKEM LABORATORIES LTD.-VILLAGE THANA, BADDI, DISTT. SOLAN,HIMACHAL PRADESH 173205 INDIA. INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0X1.0 G VIAL01/07/2011
1310NDA/MAL/HDP/2122ELYS CHEMICAL INDUSTRIES LTDVELVET PHARMA LIMITEDELYMOLPARACETAMOL120MG/5MLELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBI KENYAORAL LIQUID ORDINARY SUSPENSIONS1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE01/07/1997
1311NDA/MAL/HDP/2123VHB MEDI SCIENCES LTDLLOYDS PHARMACY LIMITEDPLATFIRSTCISPLATIN1MG/MLVHB MEDI SCIENCES LTD-PLOT 20, 21, 22 & 49,50, 51. INTEGRATED INDUSTRIAL AREA SECTOR 5, RUDRAPUR, UTTARAKHAND - INDIA INDIAPARENTERAL ORDINARY VIALS1.0X50.0 ML VIAL07/01/14
1312NDA/MAL/HDP/2124ELYS CHEMICAL INDUSTRIES LTDVELVET PHARMA LIMITEDELYMOXAMOXYCILLIN125MG/5MLELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBI KENYAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE01/07/1997
1313NDA/MAL/HDP/2125CIPLA LTDQUALITY CHEMICALS LTD - HUMANBECLATE 100BECLOMETASONE100MCG/DOSECIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA INDIANASAL SYSTEMIC METERED-DOSE LIQUIDS1.0X200.0 METERED DOSE CANNISTER01/07/2009
1314NDA/MAL/HDP/2128HILTON PHARMA (PVT) LTDHEALTHCARE LTD.TRANSAMIN INJECTION 500MGTRANEXAMIC ACID500MG/5MLHILTON PHARMA (PVT) LTD-PLOT 13 SECTOR 15 KORANGI INDUSTRIAL AREA KARACHIPAKISTANPARENTERAL ORDINARY AMPOULES1.0X10.0X5.0 ML AMPOULE01/07/2005
1315NDA/MAL/HDP/2129DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDGAMA PHARMACEUTICALS (U) LIMITEDCLAVODARAMOXICILLIN/CLAVULANIC ACID500MG/125MGDAR AL DAWA-NA'UR PLANT AMMANJORDANORAL SOLID ORDINARY TABLETS1.0X2.0X7.0 TABLET BLISTER01/07/2011
1316NDA/MAL/HDP/2130IPCA LABORATORIESMEDVIN PHARMA LIMITEDZERODOL-CRACECLOFENAC200MG IPCA LABORATORIES LTD-PLOT NO. 255/1,
VILLAGE ATHAL,
SILVASSA-396230,
DADRA AND NAGAR HAVELI, INDIA.
INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2011
1317NDA/MAL/HDP/2132AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDLOPINAVIR/ RITONAVIRLOPINAVIR/ RITONAVIR200MG/ 50MGAUROBINDO PHARMA LTD-UNIT III-SURVEY NO.313,BACHUPALLY VILLAGE,QUTHUBULLAPUR MANDAL R.R DISTRICT(A.P),INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X120.0 TABLET CONTAINER01/07/2010
1318NDA/MAL/HDP/2133NOVO NORDISKSTAR PHARMACEUTICALS LTDACTRAPIDHUMAN INSULIN100 I.U/MLNOVO NORDISK PHARMA-NOVO ALLEDENMARKPARENTERAL ORDINARY S C VIALS1.0X10.0 ML VIAL01/07/1997
1319NDA/MAL/HDP/2134CADILA PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.CEFAMOR-250CEFALEXIN250MGLA-MED HEALTHCARE PVT LTD-1389 TRASAD ROAD, DHOLKA, AHMEDABAD, GUJARAT INDIA INDIAORAL SOLID ORDINARY CAPSULES1.0X5.0X20.0 CAPSULE BLISTER01/07/1997
1320NDA/MAL/HDP/2135VHB MEDI SCIENCES LTDLLOYDS PHARMACY LIMITEDSOLITAXCEFTRIAXONE1GVHB MEDI SCIENCES LTD-PLOT 20, 21, 22 & 49,50, 51. INTEGRATED INDUSTRIAL AREA SECTOR 5, RUDRAPUR, UTTARAKHAND - INDIA INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0 G VIAL07/01/10
1321NDA/MAL/HDP/2136MEDICAL UNION PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.SEDIPROCT SUPOSITORYHYDROCORTISONE+ CINCHOCAINE+ ESCULOSIDE+ FRAMYCETIN5MG + 5MG +10MG +10MGMEDICAL UNION PHARMA .CO-ABU-SULTAN ISMAILIA EGYPTEGYPTTOPICAL EXTERNAL SUPPOSITORIES1.0X6.0 SUPPOSITORY STRIP01/07/2003
1322NDA/MAL/HDP/2141CENTAUR PHARMACEUTICALS PRIVATE LIMITEDGITTOES PHARMACEUTICALS LIMITEDINFLAZONEMULTIINGREDIENTN/ACENTAUR PHARMACEUTICALS PVT LTD --PLANT II PLOT 39-41 TIVIM INDUSTRIAL ESTATE KARASWADA MAPUSA GOA 403 526INDIATOPICAL EXTERNAL OINTMENTS1.0X30.0 G TUBE01/07/2005
1323NDA/MAL/HDP/2144EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDEPICOTILTENOXICAM20MGEGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREAEGYPTPARENTERAL ORDINARY VIALS1.0X3.0 VIAL CARTON + 1*3*2ML WFI AMPOULE01/07/2014
1324NDA/MAL/HDP/2149BAYER PHARMA AGSURGIPHARM (U) LIMITEDPRIMOLUT DEPOTHYDROXYPROGESTERONE HEXANOATE250MGBAYER PHARMA A.G-MULLERSTRASSE 178, 13353 BERLIN, GERMANY GERMANYPARENTERAL ORDINARY AMPOULES1.0X1.0 ML AMPOULE01/07/1997
1325NDA/MAL/HDP/2151USV PRIVATE LIMITEDABACUS PHARMA (AFRICA) LIMITEDGLYCOMET 850METFORMIN850MGFREDUN PHARMACEUTICALS LIMITED---14,15,16 ZORABIAN INDUSTRIAL COMPLEX PALAGHAR (EAST), DIST THANE 401 404 INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2000
1326NDA/MAL/HDP/2154ABACUS PHARMA (AFRICA) LIMITEDABACUS PHARMA (AFRICA) LIMITEDGLYNASEGLIPIZIDE5MGFREDUN PHARMACEUTICALS LIMITED---14,15,16 ZORABIAN INDUSTRIAL COMPLEX PALAGHAR (EAST), DIST THANE 401 404 INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2000
1327NDA/MAL/HDP/2156NIRMA LIMITED (HEALTHCARE DI VISION) NIRLIFE HEALTHCARELIFE PHARMA AFRICA LIMITEDNIRPID 10 INTRAVENOUS FAT EMULSIONSOYA OIL10%W/VACULIFE HEALTHCARE PVT. LTD-VILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARAT INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X500.0 ML BOTTLE01/07/2011
1328NDA/MAL/HDP/2158NIRMA LIMITED (HEALTHCARE DI VISION) NIRLIFE HEALTHCARELIFE PHARMA AFRICA LIMITEDNIRPIDINTRAVENOUS FAT EMULSION20%W/VACULIFE HEALTHCARE PVT. LTD-VILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARAT INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X500.0 ML BOTTLE01/07/2010
1329NDA/MAL/HDP/2159SANOFI PASTEURLABOREX UGANDA LIMITEDVAXIGRIPINFLUENZA VIRUS STRAINS H1N1 + H3N2 + B15MCG + 15MCG + 15MCGSANOFI PASTEUR-1541 AVENUE MARCEL MERIEUX, 69280 MARCY, LETOILE SANOFI PASTEUR S.A-2,AVENUE PONT PASTEUR 69007 LYON-FRANCE(BUSINESS ADDRESS) FRANCEPARENTERAL ORDINARY PRE-FILLED SYRINGES1.0X0.5 ML PRE- FILLED SYRINGE (1 DOSE)01/07/2011
1330NDA/MAL/HDP/2160EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDACEM-500CLARITHROMYCIN500MGEMCURE PHARMACEUTICALS LTD-LANE NO.3 PHASE II SIDCO INDUSTRIAL COMPLEX BARI BRAHMANA JAMMU (J&K) 18113INDIAORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER01/07/2005
1331NDA/MAL/HDP/2161REMEDICA LTDGOODMAN INTERNATIONAL LTDCYCLOVAX CREAMACICLOVIR5%W/WREMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR CYPRUSTOPICAL EXTERNAL CREAMS1.0X10.0 G TUBE01/07/1997
1332NDA/MAL/HDP/2164ELYS CHEMICAL INDUSTRIES LTDVELVET PHARMA LIMITEDELYCORTHYDROCORTISONE1%W/WELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBI KENYATOPICAL EXTERNAL OINTMENTS1.0X15.0 G TUBE01/07/1997
1333NDA/MAL/HDP/2165RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDTRAMARENTRAMADOL HYDROCHLORIDE50MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA UGANDAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER07/01/14
1334NDA/MAL/HDP/2170ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDALSARTAN-AMLOSARTAN + AMLODIPINE50MG + 5MGARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO. II, MANDIDEEP-462046, DIST. - RAISEN, MADHYA PRADESH, INDIA. INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X4.0X7.0 TABLET BLISTER01/07/2011
1335NDA/MAL/HDP/2171IDAKIMSY MEDS LTDCO-TRIMOXAZOLE 120MG BPCO-TRIMOXAZOLE100MG/20MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER01/07/2005
1336NDA/MAL/HDP/2173GLENMARK PHARMACEUTICALS LTDSTAR PHARMACEUTICALS LTDGLEVO-500LEVOFLOXACIN500MGGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D INDIAORAL SOLID ORDINARY TABLETS1.0X5.0X5.0 TABLET BLISTER01/07/2003
1337NDA/MAL/HDP/2175CIPLA LTDQUALITY CHEMICALS LTD - HUMANPARAFIZZPARACETAMOL500MGCIPLA LTD .-PLOT NO. 9, 10 AND 15, INDORE SPECIAL ECONOMIC ZONE, PHASE –II, PITHAMPUR, DISTRICT DHAR, PIN CODE: 454775, MADHYA PRADESH INDIAORAL SOLID ORDINARY SOLUBLE TABLETS1.0X12.0X4.0 TABLET STRIP,1.0X4.0X4.0 TABLET STRIP01/07/2005
1338NDA/MAL/HDP/2176INTAS PHARMACUITICALS LTDNORVIK ENTERPRISES LIMITEDRISPITAS-2RISPERIDONE2MGINTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X5.0X10.0 TABLET BLISTER07/01/11
1339NDA/MAL/HDP/2177KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAM ERYMYCINERYTHROMYCIN ESTOLATE125MG/5MLKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALAUGANDAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE01/07/1997
1340NDA/MAL/HDP/2178KOTRA PHARMA (M) SDN BHDABACUS PHARMA (AFRICA) LIMITEDAXCEL CEFUROXIME-250CEFUROXIME AXETIL250MGKOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA MALAYSIAORAL SOLID ORDINARY CAPSULES1.0X10.0 CAPSULE BLISTER01/07/2008
1341NDA/MAL/HDP/2179BEIJING HOLLEY COTEC PHARMA CHINASUPER PHARMACEUTICALS LIMITEDPENICINBENZYLPENICILLIN1MEGAREYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100 CHINAPARENTERAL ORDINARY DRY VIALS1.0X50.0 VIAL CARTON01/07/2013
1342NDA/MAL/HDP/2180KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAM PEN VPHENOXYMETHYLPENICILLIN125MG/5MLKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALAUGANDAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE01/07/1997
1343NDA/MAL/HDP/2181KAMPALA PHARMACEUTICAL INDUSTRIES LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAM PHENPHENOXYMETHYLPENICILLIN250MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALAUGANDAORAL SOLID ORDINARY TABLETS100.0 TABLET CONTAINER,1000.0 TABLET CONTAINER,500.0 TABLET CONTAINER,250.0 TABLET CONTAINER01/07/1997
1344NDA/MAL/HDP/2183CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDOCID I.V.OMEPRAZOLE40MG/VIALCADILA HEALTHCARE LTD-PLOT 203-213, KUNDAIM INDUSTRIAL ESTATE, GOA INDIAPARENTERAL ORDINARY VIALS1.0X1.0 VIAL CARTON01/07/2007
1345NDA/MAL/HDP/2184KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAM QUIN MIXTURESQUININE100MG/5MLKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALAUGANDAORAL LIQUID ORDINARY LIQUIDS1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE01/07/1997
1346NDA/MAL/HDP/2185GLAXOSMITHKLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDROTARIXLIVE ATTENUATED RIX4414 STRAIN OF HUMAN ROTAVIRUS OF THE G1P[8] TYPENOT LESS THAN 10? CCID?? OF THE RIX4414 STRAINGLAXOSMITHKLINE BOILOGICALS-S.A RUE DE I'INSTITUT 89 B-1330 RIXENSARTBELGIUMORAL LIQUID ORDINARY LIQUIDS1.0X1.5 ML TUBE (1 DOSE)01/07/2013
1347NDA/MAL/HDP/2186KOTRA PHARMA (M) SDN BHDABACUS PHARMA (AFRICA) LIMITEDAXCEL DIPHENHYDRAMINE PAEDIATRIC SYRUPDIPHENHYDRAMINE HYDROCHLORIDE + AMMONIUM CHLORIDE7MG+67.5MG/5MLKOTRA PHARMA-BHD
1, JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA, MALAYSIA
MALAYSIAORAL LIQUID ORDINARY SYRUPS1.0X60.0 ML BOTTLE01/07/2008
1348NDA/MAL/HDP/2187CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDVOMIZONDANSETRON4MG/2MLCADILA HEALTHCARE LTD---SARKHEJ-PLOT 417,419,420, SARKHEJ-BAVLA NH NO.8A,VILLAGE: MORAIYA TAL: SANAND DISTRICT AHMEDABAD 382210 INDIAPARENTERAL ORDINARY AMPOULES1.0X5.0X2.0 ML AMPOULE,1.0X5.0X4.0 ML AMPOULE01/07/2005
1349NDA/MAL/HDP/2188CIPLA LTDQUALITY CHEMICALS LTD - HUMANPREDNISOLONEPREDNISOLONE5MGCIPLA LTD .-PLOT NO. S-103 TO S-105, S-107 TO S-112, L-147 TO L-1147-1, VERNA ELECTRONIC CITY GOA INDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER01/07/2010
1350NDA/MAL/HDP/2189KOTRA PHARMA (M) SDN BHDABACUS PHARMA (AFRICA) LIMITEDAXCEL BETAMETHASONEBETAMETHASONE0.1%W/WKOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA MALAYSIATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE,1.0X5.0 G TUBE01/07/2008
1351NDA/MAL/HDP/2191LABORATORY AND ALLIED LTDHARLEYS UGANDA LIMITEDKLOXYCLOXACILLIN250MGLABORATORY & ALLIED LTD.---PLOT 209/10349 OFF MOMBASA RD NAIROBIKENYAORAL SOLID ORDINARY CAPSULES1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER01/07/1997
1352NDA/MAL/HDP/2193CIPLA LTD..QUALITY CHEMICALS LTD - HUMANCIPLOX-500CIPROFLOXACIN500MGCIPLA LIMITED.-PLOT NO. L-139, S-103 & M-62, VERNA INDUSTRIAL ESTATE, VERNA SALCETTE, GOA, PIN 403722 INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CONTAINER01/07/2007
1353NDA/MAL/HDP/2196PFIZER LABORATORIES LTDLABOREX UGANDA LIMITEDMYCOBUTINRIFABUTIN150MGPHARMACIA AND UPJOHN S.P.A ITALY-VIA COMMESCION MARINO DEL TRONTO(ASCOLI PICENE)ITALYITALYORAL SOLID ORDINARY CAPSULES1.0X30.0 CAPSULE BOTTLE01/07/1998
1354NDA/MAL/HDP/2197LABORATORY&ALLIED LTDHARLEYS UGANDA LIMITEDWHITFIELD'S OINTMENTBENZOIC ACID + SALICYLIC ACID6%W/W + 3%W/WLABORATORY & ALLIED LTD-PLOT NO. 209/10349
OFF MOMBASA ROAD, NAIROBI
P.O. BOX 42875, NAIROBI, KENYA.
KENYATOPICAL EXTERNAL OINTMENTS1.0X20.0 G TUBE
1355NDA/MAL/HDP/2198TROGE MEDICAL GMBHECHO PHARMACY (U) LIMITEDTRO- CEFTRIAXCEFTRIAXONE SODIUM1GREYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100 CHINAPARENTERAL ORDINARY DRY VIALS1.0X50.0 VIAL CARTON01/07/2014
1356NDA/MAL/HDP/2199MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDEUTHYROX 50MCGLEVOTHYROXINE SODIUM50MCGMERCK KGAA - -FRANKFRUTER STRASSE 250, D-64293,DARMSTADT- GERMANY GERMANYORAL SOLID ORDINARY TABLETS1.0X4.0X25.0 TABLET BLISTER,1.0X1.0X30.0 TABLET BLISTER07/01/13
1357NDA/MAL/HDP/2203REMEDICA LTDGOODMAN INTERNATIONAL LTDMYCORIL 100 VAGINAL TABLETSCLOTRIMAZOLE100MGREMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR CYPRUSVAGINAL TABLETS1.0X2.0X3.0 PESSARY STRIP01/07/1998
1358NDA/MAL/HDP/2206GALENTIC PHARMA( INDIA)PVT LTDNORVIK ENTERPRISES LIMITEDNETRA CORTHYDROCORTISONE ACETATE1%W/WGALENTIC PHARMA PVT. LIMITED-R-673, TTC MIDC, RUBALE, THANE BELAPURNAVI MUMBAI 400 701
INDIA
INDIATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE01/07/2005
1359NDA/MAL/HDP/2208KOTRA PHARMA SDN BDNABACUS PHARMA (AFRICA) LIMITEDAXCEL CEPHALEXINCEPHALEXIN MONOHYDRATE500MGKOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA MALAYSIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER01/07/2010
1360NDA/MAL/HDP/2211GALENTIC PHARMA (PVT)LTDNORVIK ENTERPRISES LIMITEDBENZYL BENZOATEBENZYL BENZOATE25%W/WGALENTIC PHARMA PVT. LIMITED-R-673, TTC MIDC, RUBALE, THANE BELAPURNAVI MUMBAI 400 701
INDIA
INDIATOPICAL EXTERNAL EMULSIONS1.0X200.0 ML BOTTLE,1.0X100.0 ML BOTTLE,1.0X1000.0 ML BOTTLE01/07/2005
1361NDA/MAL/HDP/2212DENK PHARMABENLE CONSULT LIMITEDCIPRO-DENK 500CIPROFLOXACIN500MGALLPHARMED PHARBIL ARZNEIMITTEL GMBH-12 D377081GERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER01/07/2005
1362NDA/MAL/HDP/2216GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDMETOCLOPRAMIDEMETOCLOPRAMIDE5MG/MLNINGBO DAHONGYING PHARMACEUTICAL CO.LTD-NO. 396 MINGZHU ROAD, HI-TECH PARK, NINGBO CITY ZHEJIANG PROVINCE, CHINA CHINAPARENTERAL ORDINARY AMPOULES1.0X10.0X10.0X2.0 ML AMPOULE01/07/2005
1363NDA/MAL/HDP/2217GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAMINOPHYLINEAMINOPHYLLINE20MGNINGBO DAHONGYING PHARMACEUTICAL CO.LTD-NO. 396 MINGZHU ROAD, HI-TECH PARK, NINGBO CITY ZHEJIANG PROVINCE, CHINA CHINAPARENTERAL ORDINARY AMPOULES1.0X50.0X10.0 ML AMPOULE01/07/2005
1364NDA/MAL/HDP/2218LEBEN LABORATORIES LTDANDYCO PHARMACY (UGANDA) LTDZINECTIL-100CHLORPROMAZINE100MGLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER01/07/2008
1365NDA/MAL/HDP/2219BAYER PHARMA AGSURGIPHARM (U) LIMITEDPRIMOLUT NNORETHISTERONE5MGBAYER WEIMAR GMBH & CO. KG-DOBEREINERSTRASSE 20 D-99427 WEIMAR, GERMANY GERMANYORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X30.0 TABLET CONTAINER01/07/1997
1366NDA/MAL/HDP/2220CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDAMLODAC 5AMLODIPINE BESYLATE5MGCADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA INDIAORAL SOLID ORDINARY TABLETS10.0X10.0 TABLET STRIP,1.0X3.0X10.0 TABLET BLISTER01/07/2003
1367NDA/MAL/HDP/2224VOGEN LABORATORIES LTDBUFFALO HEALTH CARE LTDDURAMOX 500AMOXICILLIN500MGVOGEN LABORATORIES LTD-70, M.HERACLEOUS STR. AYIOS ATHANASIOS INDUSTRIAL AREA, LIMASSOL, CYPRUS CYPRUSORAL SOLID ORDINARY CAPSULES1.0X2.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER01/07/2007
1368NDA/MAL/HDP/2226WIN-MEDICARE PVT LTDSURGIPHARM (U) LIMITEDHEPA-MERZ GRANULESL-ORNITHINE-L-ASPARTATE3G/5GWIN-MEDICARE PRIVATE LIMITED-MEERUT-MUZAFFARNAGAR ROAD, MODIPURAM - 250110 UTTAR PRADESH INDIAORAL LIQUID ORDINARY OTHER POWDERS/GRANULES1.0X10.0X5.0 G SACHET01/07/2004
1369NDA/MAL/HDP/2231MEDIPHARM INDUSTRIES LTDMEDIPHARM INDUSTRIES (E.A) LTDPIRITEX WITH CODEINEMULTI-INGREDIENTMULTI-INGREDIENTMEDIPHARM INDUSTRIES( EA) LTD-PLOT 65 KAKAJJO ROAD BWEYOGERERE P.O.BOX 6218,KAMPALA,UGANDA UGANDAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE01/07/1997
1370NDA/MAL/HDP/2232UNITED PHARMACEUTICAL MANUFACTURING CO. LTDWIDE SPECTRUM ENTERPRISES (U) LIMITEDUNICASTMONTELUKAST10MGUNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD-P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSINGJORDANORAL SOLID ORDINARY CHEWABLE TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2011
1371NDA/MAL/HDP/2233ASTRAZENECAMACNAUGHTON LIMITEDPULMICORT NEBULISERBUDESONIDE0.25MG/MLASTRA ZENECA SWEDEN OPERATIONS LIQUID PRODUCTION -KVARNBERGAGATANLZ SE-151-85,SWEDEN SWEDENLUNG ADMINISTRATION LIQUID FOR INHALATION1.0X4.0X5.0X2.0 ML VIAL01/07/2011
1372NDA/MAL/HDP/2235WOCKHARDT LTDABACUS PHARMA (AFRICA) LIMITEDWOSULIN-NINSULIN HUMAN(RECOMBINANT DNA ORIGIN)100IU/MLWOCKHARDT-WOCKHARDT BIOTECH PARK, H14/2, M.I.D.C, WALUJ, AURANGABAD 431136 MAHARASHTRA INDIAPARENTERAL ORDINARY S C VIALS1.0X3.0 ML VIAL,1.0X10.0 ML VIAL01/07/2006
1373NDA/MAL/HDP/2236NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDTEGRETOL 200CARBAMAZEPINE200MGNOVARTIS FARMA S.P.A.-VIA PROVINCIALE SCHITO 131, 80058 TORRE ANNUNZIATA, ITALY ITALYORAL SOLID ORDINARY TABLETS1.0X5.0X10.0 TABLET BLISTER01/07/1997
1374NDA/MAL/HDP/2237WOCKHARDT LTDABACUS PHARMA (AFRICA) LIMITEDWOSULIN-30/70INSULIN HUMAN(RECOMBINANT DNA ORIGIN)100I.U/MLWOCKHARDT LIMITED --WOCKHARDT BIOTECH PARK, H14/2, M.I.D.C, WALUJ, AURANGABAD 431136 MAHARASHTRA INDIA INDIAPARENTERAL ORDINARY S C VIALS1.0X10.0 ML VIAL,1.0X3.0 ML VIAL01/07/2006
1375NDA/MAL/HDP/2238UNI MEDICO LABSHREEJI PHARMACEUTICALS LIMITEDUMOCLOXAMPICILLIN + CLOXACILLIN125MG +125MGUNI MEDICOLABS.- 21-22 PHARMACITY SELAQUI DEHRADUN 248197INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE01/07/2015
1376NDA/MAL/HDP/2239NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDTEGRETOL ORAL SUSPENSIONCARBAMAZEPINE20MG/MLDELPHARMA HUNINGUE S.A.S-26, RUE DE LA CHAPELLE, 68330 HUNINGUE, FRANCE FRANCEORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE,1.0X250.0 ML BOTTLE01/07/2006
1377NDA/MAL/HDP/2241IVEE AQUA EPZ LTDASTRA PHARMA (U) LIMITEDIVYPHENOCOL EYE DROPSCHLORAMPHENICOL0.5%W/VIVEE INFUSIONS EPZ LTD--LR NO.18474/84,ATHI RIVER BOX 25251 00100 NAIROBI KENYA ATHI RIVER,KENYA KENYAOPHTHALMIC DROPS5.0 ML VIAL,10.0 ML VIAL01/07/2000
1378NDA/MAL/HDP/2242REMEDICA LTDGOODMAN INTERNATIONAL LTDCYCLOVAX 200 TABLETSACYCLOVIR200MGREMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR CYPRUSORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/1997
1379NDA/MAL/HDP/2243AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITEDROYAL PHARMA 2011 LIMITEDSIMDOL TABLETSPARACETAMOL500MGAFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED-PLOT 9-12,DEWAN & SONS INDL. AREA, VEOOR,PALGHAR-401404. INDIA.
INDIAORAL SOLID ORDINARY TABLETS10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER01/07/1997
1380NDA/MAL/HDP/2244IVEE INFUSIONS EPZ LTDASTRA PHARMA (U) LIMITEDIVYDEXNICOL EYE DROPSDEXAMETHASONE/CHLORAMPHENICOL0.1% & 1%W/VIVEE INFUSIONS EPZ LTD--LR NO.18474/84,ATHI RIVER BOX 25251 00100 NAIROBI KENYA ATHI RIVER,KENYA KENYAOPHTHALMIC DROPS1.0X5.0 ML BOTTLE01/07/2000
1381NDA/MAL/HDP/2245RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDX-PELMEBENDAZOLE100MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA UGANDAORAL SOLID ORDINARY CHEWABLE TABLETS1.0X1000.0 TABLET CONTAINER01/07/2008
1382NDA/MAL/HDP/2247CIPLA LTD.QUALITY CHEMICALS LTD - HUMANESOMACESOMEPRAZOLE20MGOKASA PHARMA PVT LTD-L-2, ADDITIONAL M.I.D.C. AREA, SATARA SATARA-415004, MAHARASHTRA, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2012
1383NDA/MAL/HDP/2248GALENTIC PHARMA (PVT)LTDNORVIK ENTERPRISES LIMITEDTETRACYCLINE OPHTHALMICTETRACYCLINE1%W/WGALENTIC PHARMA PVT. LIMITED-R-673, TTC MIDC, RUBALE, THANE, INDIA INDIAOPHTHALMIC OINTMENTS1.0X3.5 G TUBE,1.0X5.0 G TUBE01/07/2004
1384NDA/MAL/HDP/2249WOCKHARDT LTDABACUS PHARMA (AFRICA) LIMITEDWOSULIN-RINSULIN100MLWOCKHARDT LIMITED --WOCKHARDT BIOTECH PARK, H14/2, M.I.D.C, WALUJ, AURANGABAD 431136 MAHARASHTRA INDIA INDIAPARENTERAL ORDINARY S C VIALS1.0X3.0 ML VIAL,1.0X10.0 ML VIAL01/07/2006
1385NDA/MAL/HDP/2250GALENTIC PHARMA LTDNORVIK ENTERPRISES LIMITEDCANDIGENCLOTRIMAZOLE1%W/WGALENTIC PHARMA PVT. LIMITED -R-673, TTC MIDC, RUBALE, THANE BELAPUR NAVI MUMBAI 400 701
INDIA
INDIATOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE01/07/2004
1386NDA/MAL/HDP/2252JOHNSON&JOHNSON PTY LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDVERMOXMEBENDAZOLE500MGSPECPHARM HOLDINGS- 15TH ROAD HALFWAY HOUSESOUTH AFRICAORAL SOLID ORDINARY CHEWABLE TABLETS1.0X1.0 TABLET BLISTER01/07/2000
1387NDA/MAL/HDP/2253GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDINDOMETHACININDOMETHACIN25MGNINGBO DAHONGYING PHARMACEUTICAL CO LTD-NO 396, MINGZHU ROAD NINGBO CITY CHINA CHINAORAL SOLID ORDINARY CAPSULES1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER01/07/2005
1388NDA/MAL/HDP/2254MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDBURN CUR CREAMACRIFLAVINE/THYMOLN/ATORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506INDIATOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE01/07/1998
1389NDA/MAL/HDP/2256GLAXOSMITH KLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDAUGMENTIN 457MG/5MLAMOXICILLIN + CLAVULANIC ACID400 MG + 57 MG / 5 MLSMITHKLINE BEECHAM PHARMACEUTICALS,-CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QH UNITED KINGDOMORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X1.0X70.0 ML BOTTLE01/07/2010
1390NDA/MAL/HDP/2258MYLAN LABORATORIES LIMITED (OTL)KIMSY MEDS LTDTENOFOVIR DISOPROXIL + LAMIVUDINE + EFAVIRENZTENOFOVIR DISOPROXIL + LAMIVUDINE + EFAVIRENZ300MG/300MG/600MGMYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE
MYLAN LABORATORIES LTD -- PLOT NO. H-12 & H-13 MIDCWALUJ INDUSTRIAL AREA AURANGABAD 431136 MAHARASTRA GREEN STONE LIMITED-PLOT NO. 11,12&13 INDORE SPECIAL ECONOMIC ZONE QUESTA CARE LIMITED-PLOT NO 209/7184 HOMABAY RD TERMINUS GATE NO-19, INDUSTRIAL AREA NAIROBI, KENYA.
INDIAORAL SOLID ORDINARY TABLETS1.0X100.0 TABLET BOTTLE,1.0X1.0X30.0 TABLET BOTTLE07/01/09
1391NDA/MAL/HDP/2262CIPLA LTDQUALITY CHEMICALS LTD - HUMANTENOFOVIR DISOPROXIL FUMARATETENOFOVIR DISOPROXIL FUMARATE300MGCIPLA LTD .-PLOT NO. S-103 TO S-105, S-107 TO S-112, L-147 TO L-1147-1, VERNA ELECTRONIC CITY GOA INDIAORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET BOTTLE01/07/2010
1392NDA/MAL/HDP/2263OTSUKA PHARMACEUTICAL INDIA PRIVATE LIMITEDREDDYS PHARMA LIMITEDCELEMIN 10 PLUSAMINO ACIDS/ELECTROLYTES10%W/V+10%W/VOTSUKA PHARMACEUTICAL INDIA PRIVATE LTD-VILLAGE – VASANA – CHACHARWADIP, TAL: SANAND, AHMADABAD INDIAPARENTERAL ORDINARY INFUSION BAGS1.0X500.0 ML BOTTLE07/01/01
1393NDA/MAL/HDP/2265HETERO DRUGS LTDAIVEEN (U) LIMITEDTENOFOVIR/ LAMUVIDINETENOFOVIR DISOPROXIL FUMARATE + LAMIVUDINE300MG + 300MGHETERO LABS LTD (UNIT-V)-SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIA HETERO LABS LTD-22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESH INDIAORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET BOTTLE01/07/2010
1394NDA/MAL/HDP/2267MYLAN LABORATORIES LIMITED (OTL)KIMSY MEDS LTDTENOFOVIR DISOPROXIL FUMARATE + LAMIVUDINETENOFOVIR DISOPROXIL FUMARATE + LAMIVUDINE300MG+300MGMYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE
MYLAN LABORATORIES LTD -- PLOT NO. H-12 & H-13 MIDCWALUJ INDUSTRIAL AREA AURANGABAD 431136 MAHARASTRA QUESTA CARE LIMITED-PLOT NO 209/7184 HOMABAY RD TERMINUS GATE NO-19, INDUSTRIAL AREA NAIROBI, KENYA.
INDIAORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET BOTTLE07/01/07
1395NDA/MAL/HDP/2269DAWA LIMITEDSUPER MEDIC LTDDAWAMOXAMOXYCILLIN TRIHYDRATE125MG/5MLDAWA PHARMACEUTICALS LIMITED-PLOT 7879, BABA DOGO ROAD RUARAKA KENYAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE01/07/1997
1396NDA/MAL/HDP/2270UNIQUE PHARMACEUTICAL LABORATORIESTATA UGANDA LIMITEDZITHROCIN 500AZITHROMYCIN500MGJ.B. CHEMICALS AND PHARMACEUTICALS LTD .-128/1, G.I.D.C. INDUSTRIAL AREA, ANKLESHWAR, GUJARAT 393002 INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X3.0 TABLET BLISTER01/07/2006
1397NDA/MAL/HDP/2271EAGLEVET UGANDA LIMITEDMEDVIN PHARMA LIMITEDARTEMETHER 20MG/LUMEFANTRINE 120MGARTEMETHER + LUMEFANTRINE20MG + 120MG IPCA LABORATORIES LTD-PLOT NO. 255/1,
VILLAGE ATHAL,
SILVASSA-396230,
DADRA AND NAGAR HAVELI, INDIA.
INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X3.0X6.0 TABLET BLISTER,1.0X30.0X18.0 TABLET BLISTER,1.0X30.0X24.0 TABLET BLISTER,1.0X10.0X1.0X6.0 TABLET BLISTER,1.0X10.0X2.0X6.0 TABLET BLISTER,1.0X30.0X12.0 TABLET BLISTER,1.0X30.0X4.0X6.0 TABLET BLISTER,1.0X30.0X3.0X6.0 TABLET BLISTER,1.0X30.0X2.0X6.0 TABLET BLISTER,1.0X30.0X6.0 TABLET BLISTER,1.0X10.0X4.0X6.0 TABLET BLISTER01/07/2010
1398NDA/MAL/HDP/2272AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDCLARANTA -500CLARITHROMYCIN500MGAJANTA PHARMA LTD .-B-4//5/6, MIDC INDUSTRIALAREA, PAITHAN-431 128, AURANGBAD INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X2.0X10.0 TABLET BLISTER01/07/2005
1399NDA/MAL/HDP/2278AVENTIS INTERCONTINENTALLABOREX UGANDA LIMITEDORELOXCEFPODOXIME PROXETIL100MGSANOFI WINTHROP INDUSTRIE-SANOFI WINTHROP INDUSTRIE
56, RUE DE CHOISY AU BAC
60205 COMPIÈGNE
FRANCEORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER01/07/2010
1400NDA/MAL/HDP/2281SURGE LAB (PVT) LIMITEDJEET PHARMACEUTICALS LIMITEDLUMFORTLORATADINE10MGNABIQASIM INDUSTRIES (PVT) LIMITED-17/24, KORANGI INDUSTRIAL AREA, KARACHI, PAKISTAN PAKISTANORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2007
1401NDA/MAL/HDP/2282AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDPROPANPROPRANOLOL40MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER01/07/2011
1402NDA/MAL/HDP/2283SERUM INSTITUTE OF INDIA LTD.NORVIK ENTERPRISES LIMITEDSII DIPHTHERIA TETANUS PERTUSISDIPTHERIA TOXOID+TETANUS TOXOID+B.PERTUSIS ADSORBED ON ALUMINIUM PHOSPATE>25LF(>30IU)+>5LF(>40IU)+<16OU(>4PU) ADSORBED ON ?1.5MGSERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIA INDIAPARENTERAL ORDINARY VIALS1.0X10.0 ML VIAL (20 DOSES),1.0X5.0 ML VIAL (10 DOSES),1.0X0.5 ML AMPOULE (1 DOSE)01/07/1997
1403NDA/MAL/HDP/2284SURGE LAB (PVT) LIMITEDJEET PHARMACEUTICALS LIMITEDLUMFORT SYRUPLORATADINE5MG/5MLNABIQASIM INDUSTRIES (PVT) LIMITED-17/24, KORANGI INDUSTRIAL AREA, KARACHI, PAKISTAN PAKISTANORAL LIQUID ORDINARY SYRUPS1.0X60.0 ML BOTTLE01/07/2007
1404NDA/MAL/HDP/2285MEDREICH PLCLABOREX UGANDA LIMITEDBRUMEDIBUPROFEN100MG/5MLMEDRIECH STERILAB LTD-AVALAHALLI BANGALORE-560 049, INDIA INDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X1.0X100.0 ML BOTTLE01/07/2005
1405NDA/MAL/HDP/2287GLAXO WELLCOME (KENYA) LTDUNITED HEALTHCARE DISTRIBUTORS LTDZINNATCEFUROXIME AXETIL250MGGLAXOSMITHKLINE UK LTD-HARMIRE RD BARNARD CASTLE DURHAM, DL12DT UNITED UNITED KINGDOMORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER,1.0X50.0 TABLET CARTON01/07/1997
1406NDA/MAL/HDP/2289GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDCHLORAMPHENICOLCHLORAMPHENICOL250MGNINGBO DAHONGYING PHARMACEUTICAL CO.LTD-NO. 396 MINGZHU ROAD, HI-TECH PARK, NINGBO CITY ZHEJIANG PROVINCE, CHINA CHINAORAL SOLID ORDINARY CAPSULES10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER01/07/2005
1407NDA/MAL/HDP/2290MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDLAMIVUDINE + ZIDOVUDINELAMIVUDINE + ZIDOVUDINE150MG + 300MGMYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE
MYLAN LABORATORIES LTD --H-12 & H-13, MIDC, WALUJ,AURANGABAD- 431136 MAHARASHTRA, INDIA
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X60.0 TABLET BOTTLE07/01/08
1408NDA/MAL/HDP/2291HETERO DRUGS LTDAIVEEN (U) LIMITEDVALOVIRVALACYCLOVIR500MGHETERO LABS LTD (UNIT-V)-SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIA HETERO LABS LTD-22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESH INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2011
1409NDA/MAL/HDP/2292MEDREICH PLCLABOREX UGANDA LIMITEDFLEMING 1200AMOXICILLIN SODIUM + POTASSIUM CLAVULANATE1000MG + 200MGNATCO PHARMA LTD-VIJAYAPUR, NORTH NAGARIJUNA SAGA,INDIA INDIAPARENTERAL ORDINARY DRY VIALS1.0X5.0X20.0 ML VIAL01/07/2007
1410NDA/MAL/HDP/2293GLOBAL NAPI PHARMACEUTICALSWIDE SPECTRUM ENTERPRISES (U) LIMITEDTIOCONTIOCONAZOLE1%W/WGLOBAL NAPI PHARMACEUTICALS -2ND INDUSTRIAL ZONE, NO.40, ST. NO 18, 6TH OCTOBER, GIZA, EGYPTTOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE01/07/2005
1411NDA/MAL/HDP/2296ERIS LTDBENLE CONSULT LIMITEDRANI-DENK 150RANITIDINE150MGDENK PHARMA GMBH &CO.KG-PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 GERMANYORAL SOLID ORDINARY TABLETS1.0X20.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER,1.0X50.0 TABLET CONTAINER01/07/2000
1412NDA/MAL/HDP/2297DAWA LIMITEDSUPER MEDIC LTDSABULIN SYRUPSALBUTAMOL SULPHATE2MG/5MLDAWA LIMITED -BABA DOGO RWARAKAKENYAORAL LIQUID ORDINARY SYRUPS1.0X1.0X100.0 ML BOTTLE01/07/2008
1413NDA/MAL/HDP/2298MSN LABORATORIES LTDMETRO PHARMACEUTICALS LIMITEDSAFELEVO 500LEVOFLOXACIN500MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2013
1414NDA/MAL/HDP/2303MERCK PHARMACEUTICAL MANUFACTURING (PYT) LTDUNITED HEALTHCARE DISTRIBUTORS LTDZIAK 5/6.25BISOPROLOL + HYDROCHLOROTHIAZIDE5 MG + 6.25 MGMERCK KGAA-FRANKFURTER STRASSE 250 64271 DARMSTADT GERMANYGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2014
1415NDA/MAL/HDP/2304MERCK PHARMACEUTICAL MANUFACTURING (PYT) LTDUNITED HEALTHCARE DISTRIBUTORS LTDZIAK 10/6.25BISOPROLOL + HYDROCHLOROTHIAZIDE10 MG + 6.25 MGMERCK KGAA-FRANKFURTER STRASSE 250 64271 DARMSTADT GERMANYGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2014
1416NDA/MAL/HDP/2305MERCK PHARMACEUTICAL MANUFACTURING (PYT) LTDUNITED HEALTHCARE DISTRIBUTORS LTDZIAK 2.5/6.25BISOPROLOL + HYDROCHLOROTHIAZIDE2.5 MG + 6.25 MGMERCK KGAA-FRANKFURTER STRASSE 250 64271 DARMSTADT GERMANYGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2014
1417NDA/MAL/HDP/2306BAYER PHARMA AGSURGIPHARM (U) LIMITEDMICROLUTLEVONORGESTREL0.03MGBAYER PHARMA A.G-MULLERSTRASSE 178, 13353 BERLIN, GERMANY GERMANYORAL SOLID ORDINARY TABLETS1.0X3.0X35.0 TABLET BLISTER01/07/2010
1418NDA/MAL/HDP/2307THE ARAB P'CAL MANUFACTIRING CO.GOODMAN INTERNATIONAL LTDZOCIN SUSPENSIONAZITHROMYCIN200MG/5MLARAB PHARMACEUTICAL MANUFACTURING INDUSTRIES --KING ABDULAH 2ND STREET / INDUSTRIAL AREA BUILDING NO. 1 AL-BUHAIRAH / SULT-JORDANJORDANORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X15.0 ML BOTTLE,1.0X22.5 ML BOTTLE07/01/01
1419NDA/MAL/HDP/2312REMEDICA LTDGOODMAN INTERNATIONAL LTDCLAVOMID 625AMOXICILLIN + CLAVULANIC ACID500 MG + 125 MGREMEDICA LIMITED -AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUS CYPRUSORAL SOLID ORDINARY FILM-COATED TABLETS2.0X10.0 TABLET BLISTER01/07/2006
1420NDA/MAL/HDP/2313REMEDICA LTDGOODMAN INTERNATIONAL LTDCLAVOMID 375AMOXICILLIN + CLAVULANIC ACID250 MG + 125 MGREMEDICA LIMITED -AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUS CYPRUSORAL SOLID ORDINARY FILM-COATED TABLETS2.0X10.0 TABLET BLISTER07/01/06
1421NDA/MAL/HDP/2314MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDRABEMAC-20RABEPRAZOLE SODIUM20MGMACLEODS PHARMACEUTICALS LTD -PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT), INDIA. INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET STRIP01/07/2005
1422NDA/MAL/HDP/2315MICRO LABS LTDLABOREX UGANDA LIMITEDGRAMOCEF-O-50CEFIXIME50MG/5MLMICRO LABS LIMITED, BOMMASANDRA -PLOT NO. 121-124 4TH PHASE K.I.A.D.B BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK BANGALORE 560 099 INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X30.0 ML BOTTLE,1.0X100.0 ML BOTTLE01/07/2006
1423NDA/MAL/HDP/2317ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDASMOLPARACETAMOL500MGASTRA LIFE CARE(INDIA) PVT LTD-57/P, POJODA, 382220, BOVIA, AHMEDOBAD, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X500.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER01/07/1997
1424NDA/MAL/HDP/2318MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDDIAPRIDE-4GLIMEPIRIDE4MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2006
1425NDA/MAL/HDP/2319COSMOS LTDASTRA PHARMA (U) LIMITEDCOSMOLPARACETAMOL120MG/5MLCOSMOS LIMITED-RANGWE ROAD, OFF LUNGA ROAD - INDUSTRIAL AREA NAROBI KENYAORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE01/07/1998
1426NDA/MAL/HDP/2320AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDERO-125ERYTHROMYCIN ESTOLATE125MG/5MLAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE01/07/2006
1427NDA/MAL/HDP/2321JOHNSON&JOHNSON PTY LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDBENYLIN CHESTYORCIPRENALINE+BROMHEXINE5MG/5ML+ 4MG/5MLJOHNSON&JOHNSON PTY LTD.-EDMS BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICA SOUTH AFRICAORAL LIQUID ORDINARY LIQUIDS1.0X200.0 ML BOTTLE,1.0X100.0 ML BOTTLE01/07/2001
1428NDA/MAL/HDP/2322EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDTREFLUCANFLUCONAZOLE150MGEGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREAEGYPTORAL SOLID ORDINARY CAPSULES1.0X2.0X1.0 CAPSULE STRIP01/07/2007
1429NDA/MAL/HDP/2323ELYS CHEMICAL INDUSTRIES LTDVELVET PHARMA LIMITEDALPRIMCO-TRIMOXAZOLE240MG/5MLELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBI KENYAORAL LIQUID ORDINARY SUSPENSIONS1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE,1.0X5.0 L JERRYCAN01/07/1997
1430NDA/MAL/HDP/2324SWISS PARENTERALS PVT. LTD.SHREEJI PHARMACEUTICALS LIMITEDSWISSCLOXAAMPICILLIN + CLOXACILLIN250 MG + 250 MGSWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIAINDIAPARENTERAL ORDINARY DRY VIALS1.0X7.5 ML VIAL01/07/2011
1431NDA/MAL/HDP/2325IDA FOUNDATIONKIMSY MEDS LTDPARAMOMYCINPAROMOMYCIN375MG/MLGLAND PHARMA LTD -D.P PALLY DUNDIGAL POST QUTBULLAPUR MANDAL RANGA REDDY DISTRICT HYDERABAB 500043INDIAPARENTERAL ORDINARY AMPOULES1.0X10.0X2.0 ML AMPOULE01/07/2011
1432NDA/MAL/HDP/2326EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDSYLATE-500ETAMSYLATE50MGEMCURE PHARMACEUTICALS LTD-LANE NO.3 PHASE II SIDCO INDUSTRIAL COMPLEX BARI BRAHMANA JAMMU (J&K) 18113INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X6.0 TABLET STRIP01/07/2004
1433NDA/MAL/HDP/2327AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDABACAVIR SULPHATEABACAVIR SULPHATE300MGAUROBINDO PHARMA LTD-UNIT III-SURVEY NO.313,BACHUPALLY VILLAGE,QUTHUBULLAPUR MANDAL R.R DISTRICT(A.P),INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X60.0 TABLET CONTAINER01/07/2007
1434NDA/MAL/HDP/2330NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDCOARTEMARTEMETHER + LUMEFANTRINE20MG + 120MGNOVARTIS PHARMA AG-SCHAFFHAUSERSTRASSE 4332 STEIN SWITZERLAND BEIJING NOVARTIS PHARMA LTD-31ST YONG'AN ROAD, CHANGPING DISTRICT, BEIJING P.R NORVATIS SAGLIK GIDA VE TARIM URENLERI SAN, VE TIC-AC-YENISEHIR MAHALLESI IHLA VADISI SOKAK, NO.2, 34912 KURTKOY, INSTANBUL - TURKEY SWITZERLANDORAL SOLID ORDINARY TABLETS1.0X24.0 TABLET BLISTER,1.0X30.0X24.0 TABLET BLISTER,1.0X30.0X6.0 TABLET BLISTER,1.0X36.0X6.0 TABLET BLISTER,1.0X3.0X8.0 TABLET BLISTER,1.0X30.0X12.0 TABLET BLISTER,1.0X30.0X18.0 TABLET BLISTER01/07/2005
1435NDA/MAL/HDP/2333SERUM INSTITUTE OF INDIA LTD.NORVIK ENTERPRISES LIMITEDSII DIPHTHERIA & TETANUS VACCINE ADSORBED(PEDIATRIC)DIPTHERIA TOXOID+TETANUS TOXOID ADSORBED ON ALUMINIUM PHOSPHATE>25LF(>30IU)+>5LF(>40IU) ADSORBED ON ?1.5MGSERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIA INDIAPARENTERAL ORDINARY AMPOULES1.0X10.0 ML VIAL (20 DOSES),1.0X5.0 ML VIAL (10 DOSES),1.0X0.5 ML AMPOULE (1 DOSE)01/07/1997
1436NDA/MAL/HDP/2334SERUM INSTITUTE OF INDIA LTD.NORVIK ENTERPRISES LIMITEDSII MEASLES MUMPS & RUBELLAMEASLES VIRUS+MUMPS VIRUS+RUBELLA VIRUSNLT 1000 CCID50+NLT 5000 CCID50 +NLT1000 CCID50SERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIA INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0 DOSE VIAL + 0.5ML OF THE DILUENT01/07/1997
1437NDA/MAL/HDP/2335AGOG PHARMA LTD.GITTOES PHARMACEUTICALS LIMITEDAGOBEN TABLETS(THANE)MEBENDAZOLE100MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY CHEWABLE TABLETS10.0X10.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,1.0X250.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER01/07/2001
1438NDA/MAL/HDP/2337AUROBINDO PHARMA LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDAUROXETIL-500CEFUROXIME AXETIL500MGAPI AMMAN PHARMACEUTICAL INDUSTRIES-UNIT VI, SY. NO 329/39, 329/