Drug Register (June 2022)
This list is updated regularly when available data on such products are evaluated and relevant sites are inspected by National Drug Authority. Please enter the criteria below to display products from the Drug Register database.

S/NNDA REGISTRATION NUMBERLICENSE HOLDERLOCAL TECHNICAL REPRESENTATIVENAME OF DRUGMANUFACTURERCOUNTRY OF MANUFACTUREDOSAGE FORMPACK SIZEREGISTRATION DATE
1NDA/MAL/HHP/10011GRIFFON BIOMETRIX PVT.LTDMETRO PHARMACEUTICALS LIMITEDGRIFFON BALMZOETIS MANUFACTURING AND RESEARCH SPAIN, S.L-CTRA. DE CAMPRODIN, S/N, FINCA LA RIBA, VALL DE BIANYA, 17813, GIRONA INDIATOPICAL EXTERNAL OINTMENTS1.0X10.0 G BOTTLE28/2/2022
2NDA/MAL/HHP/10012REVITAL HEALTHCARE (EPZ) LTDREVITAL HEALTH CARE LTDPILEENO OINTMENTPAUL BROOKS HOMOEO LABS-A-69, PHASE 1,SITE SUPER HIGHWAY INDUSTRIAL AREA, SCHEME 33,KARACHI-PAKISTAN PAKISTANTOPICAL EXTERNAL OINTMENTS1.0X20.0 G TUBE28/2/2022
3NDA/MAL/HHP/10013REVITAL HEALTHCARE (EPZ) LTDREVITAL HEALTH CARE LTDSLIM TRIM CAPSULES.PAUL BROOKS HOMOEO LABS-A-69, PHASE 1,SITE SUPER HIGHWAY INDUSTRIAL AREA, SCHEME 33,KARACHI-PAKISTAN PAKISTANORAL SOLID ORDINARY CAPSULES1.0X30.0 CAPSULE BLISTER28/2/2022
4NDA/MAL/HHP/10014REVITAL HEALTHCARE (EPZ) LTDREVITAL HEALTH CARE LTDNEUROCAREPAUL BROOKS HOMOEO LABS-A-69, PHASE 1,SITE SUPER HIGHWAY INDUSTRIAL AREA, SCHEME 33,KARACHI-PAKISTAN PAKISTANTOPICAL EXTERNAL OINTMENTS1.0X50.0 G TUBE28/2/2022
5NDA/MAL/HHP/10015REVITAL HEALTHCARE (EPZ) LTDREVITAL HEALTH CARE LTDDOMO CREAM.PAUL BROOKS HOMOEO LABS-A-69, PHASE 1,SITE SUPER HIGHWAY INDUSTRIAL AREA, SCHEME 33,KARACHI-PAKISTAN PAKISTANTOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE28/2/2022
6NDA/MAL/HHP/10016REVITAL HEALTHCARE (EPZ) LTDREVITAL HEALTH CARE LTDTOTO CARE.PAUL BROOKS HOMOEO LABS-A-69, PHASE 1,SITE SUPER HIGHWAY INDUSTRIAL AREA, SCHEME 33,KARACHI-PAKISTAN PAKISTANORAL LIQUID ORDINARY LIQUIDS1.0X150.0 ML BOTTLE28/2/2022
7NDA/MAL/HHP/10017REVITAL HEALTHCARE (EPZ) LTDREVITAL HEALTH CARE LTDMARKONIL CREAM.PAUL BROOKS HOMOEO LABS-A-69, PHASE 1,SITE SUPER HIGHWAY INDUSTRIAL AREA, SCHEME 33,KARACHI-PAKISTAN PAKISTANTOPICAL EXTERNAL CREAMS1.0X100.0 G TUBE28/2/2022
8NDA/MAL/HHP/10019CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDLIVOMYN TABLETSCHARAK PHARMA PVT. LTD,-PLOT NO. 371, SAYLI RAKHOLI ROAD, SILVASSA-396 230, D.T. OF DADRA & NAGAR HAVELI. INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X20.0 TABLET BLISTER7/3/2022
9NDA/MAL/HHP/10020KALBE INTERNATIONAL PTE LTDABACUS PHARMA (AFRICA) LIMITEDWOOD'S PEPPERMINT LOZENGES (ORIGINAL FLAVOUR)PT.KALBE FARMA TBK-JL.M.H.THAMRIN BLOK A3-1, KAWASAN INDUSTRI DELTA SILIKON,LIPPO CIKARANG,BEKASI- SINGAPOREORAL SOLID ORDINARY LOZENGES1.0X15.0X6.0 LOZENGE SACHET10/3/2022
10NDA/MAL/HHP/10021KALBE INTERNATIONAL PTE LTDABACUS PHARMA (AFRICA) LIMITEDWOOD'S PEPPERMINT LOZENGES(CHERRY FLAVOUR)PT.KALBE FARMA TBK-JL.M.H.THAMRIN BLOK A3-1, KAWASAN INDUSTRI DELTA SILIKON,LIPPO CIKARANG,BEKASI- SINGAPOREORAL SOLID ORDINARY LOZENGES1.0X15.0X6.0 LOZENGE SACHET10/3/2022
11NDA/MAL/HHP/10022KALBE INTERNATIONAL PTE LTDABACUS PHARMA (AFRICA) LIMITEDWOOD'S PEPPERMINT LOZENGES (ORANGE FLAVOUR)PT.KALBE FARMA TBK-JL.M.H.THAMRIN BLOK A3-1, KAWASAN INDUSTRI DELTA SILIKON,LIPPO CIKARANG,BEKASI- SINGAPOREORAL SOLID ORDINARY LOZENGES1.0X15.0X6.0 LOZENGE SACHET10/3/2022
12NDA/MAL/HHP/10023KREMOINT PHARMA PVT.LTDPLANET PHARMACEUTICALS UGANDA LTDKOFFENGES COUGH SYRUPKREMOINT PHARMA PRIVATE LIMITED-A-10/M.I.D.C. TALOJA - 410208, TAL-PANVEL, DIST: RAIGAD, MAHARASHTRA - INDIA INDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE5/4/2022
13NDA/MAL/HHP/10024GAYATRI AYUPHARMA PRIVATE LIMITEDVIDA AFRICA LTDLOZETS MENTHOMAX PLUSPRINCE SUPPLICO-PLOT NO. 90-A, G.I.D.C, CHITRA, BHAVNAGAR INDIAORAL SOLID ORDINARY LOZENGES1.0X50.0X2.0 LOZENGE BLISTER5/4/2022
14NDA/MAL/HHP/10025GAYATRI AYUPHARMA PRIVATE LIMITEDVIDA AFRICA LTDHERO PAIN BALMGAYATRI AYUPHARMA PRIVATE LIMITED-234/2/2, PATEL ESTATE, NIKOL ROAD, AHMEDABAD: 382 350, GUJARAT (INDIA) INDIATOPICAL EXTERNAL OINTMENTS1.0X10.0 ML JAR5/4/2022
15NDA/MAL/HHP/10026NEOMI PHARMACEUTICALS PVT LTDROYAL PHARMA 2011 LIMITEDNEOSILS HERBAL COUGH LOZENGESLEAMARK HEALTHCARE PVT LTD-SARKHEJ BAVLA HIGHWAY,MATODA 382213 AHMEDABAD GUJARAT INDIAORAL SOLID ORDINARY LOZENGES25.0X2.0 LOZENGE STRIP11/4/2022
16NDA/MAL/HHP/10027BHARGAVA PHYTOLAB PVT. LTDREDDYS PHARMA LIMITEDACTIVATED CHARCOAL TABLETSBHARGAVA PHYTOLAB PVT.LTD-E-1216 PHASE-1, EXTN. GHATAL,BHIWADI INDUSTRIAL AREA, BHIWADI(RAJ.) INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X90.0 TABLET BOTTLE21/4/2022
17NDA/MAL/HHP/3115SHURIK LTDSHURIK LTDRHINO BALMMEHTA UNANI PHARMACY & CO LTD-INDIAINDIATOPICAL EXTERNAL OINTMENTS1.0X20.0 G CONTAINER,1.0X10.0 G CONTAINER1/7/2001
18NDA/MAL/HHP/5500CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDAPTIZOOOM SYRUPCHARAK PHARMA PVT. LTD,-PLOT NO. 371, SAYLI RAKHOLI ROAD, SILVASSA-396 230, D.T. OF DADRA & NAGAR HAVELI. INDIA INDIAORAL LIQUID ORDINARY SYRUPS1.0X1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE1/7/2000
19NDA/MAL/HHP/5502HIMALAYA DRUG COMPANY.EUROPA HEALTHCARE (U) LTDGASEXHIMALAYA DRUG COMPANY-27256287 INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X100.0 TABLET CONTAINER,1.0X25.0 TABLET CONTAINER (PHYSICIAN'S SAMPLE)1/7/2000
20NDA/MAL/HHP/5503ABACUS PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDAMODEX OINTMENTPOOJA DRUGS-POOJA DRUGSINDIATOPICAL EXTERNAL OINTMENTS1.0X25.0 G JAR1/7/2000
21NDA/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 BOTTLE1/7/2008
22NDA/MAL/HHP/5517HIMALAYA DRUG COMPANY.EUROPA HEALTHCARE (U) LTDMENTATHIMALAYA DRUG COMPANY-27256287 INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X50.0 TABLET CONTAINER1/7/2004
23NDA/MAL/HHP/5518MACK BROWN PHARMACEUTICALS PVT LIMITEDSHURIK LTDPENODEX OINTMENTMEHTA UNANI PHARMACY & CO LTD-INDIAINDIATOPICAL EXTERNAL OINTMENTS1.0X20.0 G CONTAINER1/7/2007
24NDA/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 BOTTLE1/7/2004
25NDA/MAL/HHP/5520HIMALAYA DRUG COMPANY.EUROPA HEALTHCARE (U) LTDPILEXHIMALAYA DRUG COMPANY-27256287 INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X25.0 TABLET CONTAINER (PHYSICIAN'S SAMPLE),1.0X100.0 TABLET CONTAINER1/7/2001
26NDA/MAL/HHP/5527HIMALAYA DRUG COMPANY.EUROPA HEALTHCARE (U) LTDKOFLETHIMALAYA DRUG COMPANY-27256287 INDIAINDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE1/7/2000
27NDA/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 SACHET1/7/2009
28NDA/MAL/HHP/5530HIMALAYA DRUG COMPANY.EUROPA HEALTHCARE (U) LTDLIV.52 TABLETSHIMALAYA DRUG COMPANY-27256287 INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X100.0 TABLET BOTTLE,1.0X25.0 TABLET BOTTLE1/7/2000
29NDA/MAL/HHP/5531HIMALAYA DRUG COMPANY.EUROPA HEALTHCARE (U) LTDRUMALAYAHIMALAYA DRUG COMPANY-27256287 INDIAINDIATOPICAL EXTERNAL CREAMS1.0X30.0 G TUBE1/7/2000
30NDA/MAL/HHP/5532MACK BROWN PHARMACEUTICALS PVT LIMITEDSHURIK LTDATMANANTHAN COLD RUBMETA UNANI PHARMACY & CO PVT-G 5524, GIDC, LODHIKA METODA, DIST RAJKOT, GUJARATI INDIANASAL TOPICAL LIQUID INHALATIONS1.0X12.0X1.0 G ROD1/7/2009
31NDA/MAL/HHP/5533HIMALAYA DRUG COMPANY.EUROPA HEALTHCARE (U) LTDRUMALAYAHIMALAYA DRUG COMPANY-27256287 INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X100.0 TABLET CONTAINER,1.0X25.0 TABLET CONTAINER (PHYSICIAN SAMPLE)1/7/2000
32NDA/MAL/HHP/5536ABACUS PHARMA LTDJEET PHARMACEUTICALS 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 BOTTLE1/7/2004
33NDA/MAL/HHP/5538HIMALAYA DRUG COMPANY.EUROPA HEALTHCARE (U) LTDSEPTILINHIMALAYA DRUG COMPANY-27256287 INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X100.0 TABLET CONTAINER1/7/2000
34NDA/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 BOTTLE1/7/2015
35NDA/MAL/HHP/5547SHURIK LTDSHURIK LTDMENTHOSIL COUGH DROPMEHTA HERBALS PVT LTD-INDIAINDIAORAL SOLID ORDINARY LOZENGES1.0X35.0X2.0 LOZENGE STRIP1/7/2001
36NDA/MAL/HHP/5549HIMALAYA DRUG COMPANY.EUROPA HEALTHCARE (U) LTDBONISAN LIQUIDHIMALAYA DRUG COMPANY-27256287 INDIAINDIAORAL LIQUID ORDINARY LIQUIDS1.0X120.0 ML BOTTLE1/7/2000
37NDA/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 TUBE1/7/2015
38NDA/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 STRIP1/7/2009
39NDA/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 BOTTLE1/7/2014
40NDA/MAL/HHP/5559SHURIK LTDSHURIK LTDSTAR SKIN OINTMENTMEHTA UNANI PHARMACY & CO LTD-INDIAINDIATOPICAL EXTERNAL OINTMENTS1.0X12.0 G TUBE1/7/2001
41NDA/MAL/HHP/5561MACK BROWN PHARMACEUTICALS PVT LIMITEDSHURIK 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 CARTON1/7/2009
42NDA/MAL/HHP/5563HIMALAYA DRUG COMPANY.EUROPA HEALTHCARE (U) LTDCYSTONEHIMALAYA DRUG COMPANY-27256287 INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X100.0 TABLET CONTAINER1/7/2001
43NDA/MAL/HHP/5565ABACUS PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDDENTEX TOOTHACEPOOJA DRUGS-POOJA DRUGSINDIATOPICAL EXTERNAL LIQUIDS1.0X5.0 ML BOTTLE1/7/2000
44NDA/MAL/HHP/5570PANACEA BIOTEC PHARMA LTDVITACARE LIMITEDSITCOMPANACEA BIOTEC PHARMA LIMITED-MALPURI BADDI, DISTRICT SOLAN, HIMACHAL PRADESH-173205 - INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X2.0X7.0 TABLET BLISTER1/7/2013
45NDA/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 CONTAINER1/7/2004
46NDA/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 BLISTER1/7/2011
47NDA/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 BOTTLE1/7/2009
48NDA/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 TUBE1/7/2007
49NDA/MAL/HHP/5583HIMALAYA DRUG COMPANY.EUROPA HEALTHCARE (U) LTDEVECAREHIMALAYA DRUG COMPANY-27256287 INDIAINDIAORAL SOLID ORDINARY CAPSULES1.0X30.0 CAPSULE CONTAINER1/7/2001
50NDA/MAL/HHP/5587CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDMANOLL SYRUP CHARAK PHARMA PVT LTD-JAURASI ROAD,PAUTI VILLAGE,G.T ROAD,SAMALKHA-132 101 INDIA CHARAK PHARMA PVT. LTD,-PLOT NO. 371, SAYLI RAKHOLI ROAD, SILVASSA-396 230, D.T. OF DADRA & NAGAR HAVELI. INDIA INDIAORAL LIQUID ORDINARY SYRUPS1.0X250.0 MG BOTTLE1/7/2016
51NDA/MAL/HHP/5588CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDKOFOL (HONEY LEMON FLAVOUR)CHARAK PHARMA PVT LTD,-EVERGREEN INDUSTRIAL ESTATE, SHAUTI MILL LANE, MUMBAI-400011 INDIA INDIAORAL SOLID ORDINARY LOZENGES1.0X2.0X6.0 LOZENGE BLISTER1/7/2014
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 BOTTLE1/7/2010
53NDA/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 BOTTLE1/7/2014
54NDA/MAL/HHP/5613DR. KIM AYURVEDIC PHARMACYMEDVIN PHARMA LIMITEDSMOOTH COUGH DROPSDR KIM AYURVEDIC PHARMACY-INDIAINDIAORAL SOLID ORDINARY LOZENGES1.0X100.0X2.0 LOZENGE STRIP1/7/2005
55NDA/MAL/HHP/5618SHURIK LTDSHURIK LTDVYBRANTVITAL CARE-INDIAINDIAORAL SOLID ORDINARY CAPSULES5.0X10.0 CAPSULE BLISTER1/7/2000
56NDA/MAL/HHP/5623UNIQUE PHARMACEUTICALS LTDPLANET PHARMACEUTICALS UGANDA LTDZECUF 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 STRIP1/7/2005
57NDA/MAL/HHP/5629UNIQUE PHARMACEUTICALS LTDPLANET PHARMACEUTICALS UGANDA LTDZECUF 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 STRIP1/7/2005
58NDA/MAL/HHP/5630UNIQUE PHARMACEUTICALS LABORATORIESPLANET PHARMACEUTICALS UGANDA LTDZECUF 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 BOTTLE1/7/2000
59NDA/MAL/HHP/5631UNIQUE PHARMACEUTICALS LABORATORIESPLANET PHARMACEUTICALS UGANDA LTDZECUF 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 STRIP1/7/2014
60NDA/MAL/HHP/6848CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDKOFOL (MINT)LEAMARK HEALTHCARE PVT LTD-SARKHEJ BAVLA HIGHWAY,MATODA 382213 AHMEDABAD GUJARAT INDIAORAL SOLID ORDINARY LOZENGES1.0X3.0X4.0 LOZENGE BLISTER,1.0X2.0X6.0 LOZENGE BLISTER1/7/2016
61NDA/MAL/HHP/6850WILSHIRE LABORATORIES (PVT) LTDHEALTHCARE LTD.BENZIM NATURAL SYRUP 120MLWILSHIRE LABORATORIES LIMITED-124/1-INDUSTRIAL ESTATE, KOT LAKHPAT, LAHORE, PAKISTAN PAKISTANORAL LIQUID ORDINARY SYRUPS1.0X120.0 ML BOTTLE3/12/2016
62NDA/MAL/HHP/6852WILSHIRE LABORATORIES (PVT) LTDHEALTHCARE LTD.DE-FLU SYRUP 120MLWILSHIRE LABORATORIES LIMITED-124/1-INDUSTRIAL ESTATE, KOT LAKHPAT, LAHORE, PAKISTAN PAKISTANORAL LIQUID ORDINARY SYRUPS1.0X120.0 ML BOTTLE3/12/2016
63NDA/MAL/HHP/6853WILSHIRE LABORATORIES (PVT) LTDHEALTHCARE LTD.LIV-LONG TABLETWILSHIRE LABORATORIES LIMITED-124/1-INDUSTRIAL ESTATE, KOT LAKHPAT, LAHORE, PAKISTAN PAKISTANORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER1/7/2016
64NDA/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 BLISTER
65NDA/MAL/HHP/6915GREAT INDIA INDUSTRIAL & PHARAMCEUTICALS LABORATORIESMALIX PHARMA (U) LIMITEDGIPLA GRIPE WATERGREAT INDIA -19 SUN MILL COMPOUNDINDIAORAL LIQUID ORDINARY LIQUIDS1.0X135.0 ML BOTTLE1/7/2014
66NDA/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 BLISTER1/7/2015
67NDA/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 BOTTLE1/7/2012
68NDA/MAL/HHP/7934STAR PHARMACEUTICALS LTDSTAR PHARMACEUTICALS LTDSENSUR RUBEFACIENTGLENMARK PHARMACEUTICAL LIMITED-61-62 COMPOUND, DEWAS NAKA, LASUDIA MORI INDIATOPICAL EXTERNAL OINTMENTS1.0X30.0 G TUBE1/7/2015
69NDA/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 BLISTER1/7/2013
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72NDA/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 STRIP1/7/2014
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75NDA/MAL/HHP/7946SHEBAC PHARMANORVIK ENTERPRISES LIMITEDAPONTISAEROMAC (INDIA) INC-12, MELDI ESTATE, GOTA AHMEDABAD -382481, GUJARAT, INDIA INDIATOPICAL EXTERNAL SPRAYS WITHOUT GAS1.0X150.0 ML BOTTLE1/7/2015
76NDA/MAL/HHP/7947UNIQUE PHARMACEUTICAL LABORATORIES. (A DIVISION OF J.B. CHEMICALS AND PHARMACEUTICALS LTD)PLANET PHARMACEUTICALS UGANDA LTDZECUF 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 STRIP1/7/2014
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79NDA/MAL/HHP/7955KREMOINT PHARMA PVT.LTDPLANET PHARMACEUTICALS UGANDA LTDDICLODAY ROLL-ONKREMOINT PHARMA PVT LTD-B-8,ADDITIONAL AMBERNATH MIDC, AMBERNATH (E),DIST: THANE 421506, INDIA INDIATOPICAL EXTERNAL EMULSIONS1.0X50.0 ML BOTTLE3/12/2016
80NDA/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 BLISTER
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85NDA/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
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87NDA/MAL/HHP/8094BHARGAVA PHYTOLAB PVT. LTDREDDYS PHARMA LIMITEDPOSTORALBHARGAVA PHYTOLAB PVT. LTD -E-1216, PHASE – 1, EXTN. GHATAL, BHIWADI INDUSTRIAL AREA, BHIWADI (RAJ.) INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X2.0X15.0 TABLET BLISTER1/7/2017
88NDA/MAL/HHP/8215AMRUTANJAN HEALTH CARE LTDABACUS PHARMA (AFRICA) LIMITEDAMRUTANJAN DRAGON BACK PAIN ROLL-ONAMRUTANJAN HEALTH CARE LIMITED - -PLOT NO.14, INDUSTRIAL DEVELOPMENT AREA, UPPAL HYDERABAD - 500039, INDIA INDIATOPICAL EXTERNAL LOTIONS1.0X50.0 ML CONTAINER1/7/2004
89NDA/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 BOTTLE1/7/2017
90NDA/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 BOTTLE20/9/2017
91NDA/MAL/HHP/8505CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDLIVOMYN SYRUP CHARAK PHARMA PVT LTD-INDUSTRIALESTATE, SHAUTI MILL LANE, MUMBAI-400011 CHARAK PHARMA PVT. LTD,-PLOT NO. 371, SAYLI RAKHOLI ROAD, SILVASSA-396 230, D.T. OF DADRA & NAGAR HAVELI. INDIA INDIAORAL LIQUID ORDINARY LIQUIDS1.0X200.0 ML BOTTLE2/2/2018
92NDA/MAL/HHP/8506CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDALKA 5 SYRUPCHARAK PHARMA PVT. LTD,-PLOT NO. 371, SAYLI RAKHOLI ROAD, SILVASSA-396 230, D.T. OF DADRA & NAGAR HAVELI. INDIA INDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE2/2/2018
93NDA/MAL/HHP/8508CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDKOFOL SF SYRUP CHARAK PHARMA PVT LTD-INDUSTRIALESTATE, SHAUTI MILL LANE, MUMBAI-400011 CHARAK PHARMA PVT. LTD,-PLOT NO. 371, SAYLI RAKHOLI ROAD, SILVASSA-396 230, D.T. OF DADRA & NAGAR HAVELI. INDIA INDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE2/2/2018
94NDA/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
95NDA/MAL/HHP/8510BLISS GVS PHARMA LIMITEDMEDVIN PHARMA 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 BOTTLE6/3/2018
96NDA/MAL/HHP/8511BHARGAVA PHYTOLAB PVT. LTDREDDYS PHARMA LIMITEDTHUNDER-MBHARGAVA PHYTOLAB PVT. LTD -E-1216, PHASE – 1, EXTN. GHATAL, BHIWADI INDUSTRIAL AREA, BHIWADI (RAJ.) INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER1/7/2017
97NDA/MAL/HHP/8513BHARGAVA PHYTOLAB PVT. LTDREDDYS PHARMA LIMITEDMENIPHIBBHARGAVA PHYTOLAB PVT. LTD -E-1216, PHASE – 1, EXTN. GHATAL, BHIWADI INDUSTRIAL AREA, BHIWADI (RAJ.) INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X20.0 TABLET BLISTER1/7/2016
98NDA/MAL/HHP/8552AMRUTANJAN HEALTHCARE LIMITEABACUS 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
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99NDA/MAL/HHP/8553RAZA INTERNATIONALWIDE SPECTRUM ENTERPRISES (U) LIMITEDHONEY CUREOZONE COSMETICS & NATURAL PRODUCTS MANUFACTURING COMPANY√-SHARA BADRAN, MARJ ALFARAS, INDUSTRIAL ZONE, MUSAWAA STREET.
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100NDA/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
101NDA/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 BOTTLE28/6/2018
102NDA/MAL/HHP/9087HIMONT LABORATORIES PVT LTDBOOTS PHARMACEUTICALS LIMITEDEPITIZEHIMONT LABORATORIES PVT LIMITED-17-KM FEROZEPUR ROAD LAHORE
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103NDA/MAL/HHP/9088HIMOT LABORATORIES PVT LIMITEDBOOTS PHARMACEUTICALS LIMITEDPASMOLEX DROPSHIMOT LABORATORIES PVT LTD-17KM FEROZEPUR ROAD LAHORE PAKISTANPAKISTANORAL LIQUID ORDINARY DROPS1.0X120.0 ML BOTTLE
104NDA/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 BLISTER28/1/2019
105NDA/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 BOTTLE28/1/2019
106NDA/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 BOTTLE22/3/2019
107NDA/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 BOTTLE22/3/2019
108NDA/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 BLISTER23/4/2019
109NDA/MAL/HHP/9096HIMONT LABORATORIES PVT LTDBOOTS PHARMACEUTICALS LIMITEDCOFCIDHIMONT LABORATORIES (PVT) LTD-17KM FEROZEPUR ROAD LAHORE PAKISTANPAKISTANORAL LIQUID ORDINARY SYRUPS1.0X120.0 ML BOTTLE24/5/2019
110NDA/MAL/HHP/9097HIMONT LABORATORIES PVT LTDBOOTS PHARMACEUTICALS LIMITEDFLUCIDHIMONT LABORATORIES (PVT) LTD-17KM FEROZEPUR ROAD LAHORE PAKISTANPAKISTANORAL LIQUID ORDINARY SYRUPS1.0X120.0 ML BOTTLE24/5/2019
111NDA/MAL/HHP/9098HIMONT LABORATORIES PVT LTDBOOTS PHARMACEUTICALS LIMITEDCARIPEPTIC SYRUPHIMONT LABORATORIES (PVT) LTD-17KM FEROZEPUR ROAD LAHORE PAKISTANPAKISTANORAL LIQUID ORDINARY SYRUPS1.0X120.0 ML BOTTLE31/5/2019
112NDA/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 CARTON31/5/2019
113NDA/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 CARTON31/5/2019
114NDA/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 BOTTLE31/5/2019
115NDA/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 BOTTLE31/5/2019
116NDA/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 BOTTLE31/5/2019
117NDA/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 BOTTLE31/5/2019
118NDA/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 BLISTER31/5/2019
119NDA/MAL/HHP/9115HEALTHCARE LTD.HEALTHCARE 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 BLISTER16/7/2019
120NDA/MAL/HHP/9121HINUCONBOOTS PHARMACEUTICALS LIMITEDHILGAS INSTANT 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 CARTON11/3/2020
121NDA/MAL/HHP/9122HINUCONBOOTS PHARMACEUTICALS LIMITEDCOFERB DROPSHINUCON -PLOT NO.12/1 SECTOR 15,KORANGI INDUSTRIAL AREA, KARACHI 9TH FLOOR PROGRESSIVE PLAZA,BEAUMONT ROAD,KARACHI,PAKISTAN PAKISTANORAL LIQUID ORDINARY DROPS1.0X20.0 ML BOTTLE11/3/2020
122NDA/MAL/HHP/9123HINUCONBOOTS PHARMACEUTICALS LIMITEDCOFERB PLUS 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 BOTTLE11/3/2020
123NDA/MAL/HHP/9125HINUCONBOOTS PHARMACEUTICALS LIMITEDRIMONA 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 CARTON11/3/2020
124NDA/MAL/HHP/9126HINUCONBOOTS PHARMACEUTICALS LIMITEDCRANMAX AQUA 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 BOTTLE11/3/2020
125NDA/MAL/HHP/9127HINUCONBOOTS PHARMACEUTICALS LIMITEDFIBO JARHINUCON -PLOT NO.12/1 SECTOR 15,KORANGI INDUSTRIAL AREA, KARACHI 9TH FLOOR PROGRESSIVE PLAZA,BEAUMONT ROAD,KARACHI,PAKISTAN PAKISTANORAL LIQUID ORDINARY SOLUBLE POWDERS1.0X175.0 G JAR11/3/2020
126NDA/MAL/HHP/9128HINUCONBOOTS PHARMACEUTICALS LIMITEDELFERB 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 BOTTLE11/3/2020
127NDA/MAL/HHP/9179CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDADDYZOA CAPSULESCHARAK PHARMA PVT. LTD,-PLOT NO. 371, SAYLI RAKHOLI ROAD, SILVASSA-396 230, D.T. OF DADRA & NAGAR HAVELI. INDIA INDIAORAL SOLID ORDINARY CAPSULES1.0X20.0 CAPSULE BLISTER29/1/2020
128NDA/MAL/HHP/9182HEALTHCARE LTD.HEALTHCARE LTD.HERBICUFASIAN LIFECARE PVT.LTD-MANJUSAR,SAVLI,VADODARA,GUJARAT, INDIA PLOT NO. 3 & 3/A,SHAH INDUSTRIAL PARK-2,NEAR LAMPDAPURA CROSSING,AT&PO INDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE11/3/2020
129NDA/MAL/HHP/9185HEALTHCARE LTD.HEALTHCARE LTD.GINSEMAX-FZEE LABORATORIES LTD-BEHIND 47, INDUSTRIAL AREA, PAONTA SAHIB-173025 DISTT. SIRMOUR HIMACHAL PRADESH INDIAORAL SOLID ORDINARY OTHER CAPSULES1.0X2.0X15.0 CAPSULE BLISTER22/5/2020
130NDA/MAL/HHP/9186HEALTHCARE LTD.HEALTHCARE LTD.GINSEMAXZEE LABORATORIES LTD-BEHIND 47, INDUSTRIAL AREA, PAONTA SAHIB-173025 DISTT. SIRMOUR HIMACHAL PRADESH INDIAORAL SOLID ORDINARY OTHER CAPSULES1.0X2.0X15.0 CAPSULE BLISTER22/5/2020
131NDA/MAL/HHP/9254UNIQUE PHARMACEUTICALS LABORATORIESPLANET PHARMACEUTICALS UGANDA LTDZECUF HERBAL COUGH LOZENGES-STRAWBERRY FLAVOURUNIQUE PHARMACEUTICAL LABORATORIES ;-SURVEY NO. 101/2 & 102/1, DAMAN INDUSTRIAL ESTATE, KAPAIYA, DAMAN 396210 INDIAORAL SOLID ORDINARY LOZENGES1.0X5.0X4.0 LOZENGE STRIP18/7/2020
132NDA/MAL/HHP/9330ECHO PHARMACYECHO PHARMACY (U) LIMITEDHEMOZEL CREAMALFA MANUFACTURING LLC-4701 NW. 77 AVENUE,MIAMI,FL 33166 UNITED STATESTOPICAL EXTERNAL CREAMS1.0X40.0 G TUBE7/8/2020
133NDA/MAL/HHP/9332MEGA LIFESCIENCES PUBLIC COMPANY LTDABACUS PHARMA (AFRICA) LIMITEDEUGICA IVY SYRUPMEGA LIFESCIENCES PUBLIC CO. LTD-PLANT 1; 384 MOO 4, SOI 6, BANGPOO INDUSTRIAL ESTATE, PATTANA 3 ROAD, PHRAEKSA, MUEANG, SAMUTPRAKARN 10280 THAILAND THAILANDORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE31/8/2020
134NDA/MAL/HHP/9333MEGA LIFESCIENCES PUBLIC COMPANY LTDABACUS PHARMA (AFRICA) LIMITEDEUGICA MOUTH SPRAYMEGA LIFESCIENCES PUBLIC CO. LTD-PLANT 1; 384 MOO 4, SOI 6, BANGPOO INDUSTRIAL ESTATE, PATTANA 3 ROAD, PHRAEKSA, MUEANG, SAMUTPRAKARN 10280 THAILAND THAILANDORAL TOPICAL SPRAYS WITHOUT GAS1.0X10.0 ML BOTTLE31/8/2020
135NDA/MAL/HHP/9342GAYATRI AYUPHARMA PRIVATE LIMITEDVIDA AFRICA LTDLOZETS- ORANGEPRINCE SUPPLICO-PLOT NO. 90-A, G.I.D.C, CHITRA, BHAVNAGAR INDIAORAL TOPICAL LOZENGES1.0X2.0X12.0 LOZENGE BLISTER5/11/2020
136NDA/MAL/HHP/9343GAYATRI AYUPHARMA PRIVATE LIMITEDVIDA AFRICA LTDLOZETS-WARM GINGERPRINCE SUPPLICO-PLOT NO. 90-A, G.I.D.C, CHITRA, BHAVNAGAR INDIAORAL TOPICAL LOZENGES1.0X2.0X12.0 LOZENGE BLISTER5/11/2020
137NDA/MAL/HHP/9344GAYATRI AYUPHARMA PRIVATE LIMITEDVIDA AFRICA LTDLOZETS- COOL MINTPRINCE SUPPLICO-PLOT NO. 90-A, G.I.D.C, CHITRA, BHAVNAGAR INDIAORAL TOPICAL LOZENGES1.0X2.0X12.0 LOZENGE BLISTER5/11/2020
138NDA/MAL/HHP/9489KALBE INTERNATIONAL PTE LTDABACUS PHARMA (AFRICA) LIMITEDWOOD'S HERBAL COUGH SYRUPPT.KALBE FARMA TBK-JL.M.H.THAMRIN BLOK A3-1, KAWASAN INDUSTRI DELTA SILIKON,LIPPO CIKARANG,BEKASI- INDONESIAORAL LIQUID ORDINARY SYRUPS1.0X60.0 ML BOTTLE9/2/2021
139NDA/MAL/HHP/9558HEALTHCARE LTD.HEALTHCARE LTD.DR.ZEE HERBAL VAPOREXZEE LABORATORIES LTD-BEHIND 47, INDUSTRIAL AREA, PAONTA SAHIB-173025 DISTT. SIRMOUR HIMACHAL PRADESH INDIANASAL TOPICAL OINTMENTS1.0X25.0 G JAR1/3/2021
140NDA/MAL/HHP/9568BHARGAVA PHYTOLAB PVT LTDSHREEJI CARE LIMITEDJAGUAR POWERBHARGAVA PHYTOLAB PVT.LTD-E-1216 PHASE-1, EXTN. GHATAL,BHIWADI INDUSTRIAL AREA, BHIWADI(RAJ.) INDIA INDIAORAL LIQUID ORDINARY OTHER LIQUIDS1.0X10.0 G BOTTLE5/3/2021
141NDA/MAL/HHP/9569CHEMICURE LABORATORIES PVT. LTD.GOOD DAY PHARMACY LIMITEDVYPOGERMCHEMICURE LABORATORIES PVT. LTD-325, CHARAK MARG, UDAIPUR -313001 INDIATOPICAL EXTERNAL OINTMENTS1.0X15.0 G TIN,1.0X12.0X18.0 G TIN18/3/2021
142NDA/MAL/HHP/9570GAYATRI AYUPHARMA PRIVATE LIMITEDVIDA AFRICA LTDBIO-SLIM ACTIVEGAYATRI AYUPHARMA PRIVATE LIMITED-234/2/2, PATEL ESTATE, NIKOL ROAD, AHMEDABAD: 382 350, GUJARAT (INDIA) INDIAORAL SOLID ORDINARY CAPSULES1.0X6.0X10.0 CAPSULE BLISTER22/3/2021
143NDA/MAL/HHP/9571BHARGAVA PHYTOLAB PVT LTDSONA PHARMACEUTICALS LIMITEDHERO LIQUID BALMBHARGAVA PHYTOLAB PVT.LTD-E-1216 PHASE-1, EXTN. GHATAL,BHIWADI INDUSTRIAL AREA, BHIWADI(RAJ.) INDIA INDIATOPICAL EXTERNAL LIQUIDS1.0X10.0 ML BOTTLE15/4/2021
144NDA/MAL/HHP/9680SOUTH INDIA RESEARCH INSTITUTE PVT. LTD -VEERAM HEALTHCARE (U) LIMITEDTTK GRIPE WATERSOUTH INDIA RESEARCH INSTITUTE PVT.LTD-SIRINAGAR, VIJAYAWADA – 520 007. INDIA INDIAORAL LIQUID ORDINARY LIQUIDS1.0X130.0 ML BOTTLE17/6/2021
145NDA/MAL/HHP/9693SYDLER REMEDIES PVT LTD M-190ABACUS PHARMA (AFRICA) LIMITEDEAZOL COUGH SYRUPSYDLER REMEDIES-PRIM-190, MIDC, WALUJ, AURANGABAD-431136, MAHARASHTRA, INDIA INDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE19/7/2021
146NDA/MAL/HHP/9694GRIFFON BIOMETRIX PVT.LTDABACUS PHARMA (AFRICA) LIMITEDTHROWCUF SYRUPKESAR PHARMA PVT LTD-PLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARAT INDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE22/7/2021
147NDA/MAL/HHP/9700GRIFFON BIOMETRIX PVT.LTDMETRO PHARMACEUTICALS LIMITEDTOTO GRIPE WATERKESAR PHARMA PVT LTD-PLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARAT INDIAORAL LIQUID ORDINARY LIQUIDS1.0X120.0 ML BOTTLE27/8/2021
148NDA/MAL/HHP/9701GRIFFON BIOMETRIX PVT.LTDABACUS PHARMA (AFRICA) LIMITEDTHROWCUF PLUS SYRUPKESAR PHARMA PVT LTD-PLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARAT INDIAORAL LIQUID ORDINARY LIQUIDS1.0X100.0 ML BOTTLE27/8/2021
149NDA/MAL/HHP/9702GRIFFON BIOMETRIX PVT.LTDMETRO PHARMACEUTICALS LIMITEDGRIFFON STRONG BALMRAJESH PHARMACEUTICALS-7, DESHVALI,CHANDLODIYA ROAD,AHMEDABAD, GUJARAT 382 481 INDIATOPICAL EXTERNAL OINTMENTS1.0X9.0 ML BOTTLE27/8/2021
150NDA/MAL/HHP/9703GRIFFON BIOMETRIX PVT.LTDABACUS PHARMA (AFRICA) LIMITEDCURODEX OINTMENTRAJESH PHARMACEUTICALS-7, DESHVALI,CHANDLODIYA ROAD,AHMEDABAD, GUJARAT 382 481 INDIATOPICAL EXTERNAL OINTMENTS1.0X20.0 G BOTTLE27/8/2021
151NDA/MAL/HHP/9704GRIFFON BIOMETRIX PVT.LTDABACUS PHARMA (AFRICA) LIMITEDMENTHOXYL INHALERRAJESH PHARMACEUTICALS-7, DESHVALI,CHANDLODIYA ROAD,AHMEDABAD, GUJARAT 382 481 INDIANASAL TOPICAL LIQUID INHALATIONS1.0X0.5 ML INHALER27/8/2021
152NDA/MAL/HHP/9705PHARMA BAVARIA INTERNATIONAL GMBH -GOODMAN INTERNATIONAL LTDCALMIRELAX™LABO PHYTOPHAR NV-HANDELSTRAAT 19, 8020 OOSTKAMP, BELGIUM/BELGIQUE - BELGIUM BELGIUMORAL SOLID ORDINARY TABLETS1.0X2.0X15.0 TABLET BLISTER,1.0X15.0 TABLET BLISTER3/9/2021
153NDA/MAL/HHP/9706PHARMA BAVARIA INTERNATIONAL GMBH -GOODMAN INTERNATIONAL LTDCALMIDORMIN™LABO PHYTOPHAR NV-HANDELSTRAAT 19, 8020 OOSTKAMP, BELGIUM/BELGIQUE - BELGIUM BELGIUMORAL SOLID ORDINARY TABLETS1.0X2.0X15.0 TABLET BLISTER3/9/2021
154NDA/MAL/HHP/9707PHARMA BAVARIA INTERNATIONAL GMBH -GOODMAN INTERNATIONAL LTDDESIROLXLABO PHYTOPHAR NV-HANDELSTRAAT 19, 8020 OOSTKAMP, BELGIUM/BELGIQUE - BELGIUM BELGIUMORAL SOLID ORDINARY CAPSULES1.0X10.0 CAPSULE BLISTER,1.0X2.0X10.0 CAPSULE BLISTER3/9/2021
155NDA/MAL/HHP/9708PHARMA BAVARIA INTERNATIONAL GMBH -GOODMAN INTERNATIONAL LTDFREESPIRAX™LABO PHYTOPHAR NV-HANDELSTRAAT 19, 8020 OOSTKAMP, BELGIUM/BELGIQUE - BELGIUM BELGIUMORAL SOLID ORDINARY TABLETS1.0X15.0 TABLET BLISTER,1.0X30.0 TABLET BLISTER3/9/2021
156NDA/MAL/HHP/9709HINUCONBOOTS PHARMACEUTICALS LIMITEDLIV LIV 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 BLISTER2/9/2021
157NDA/MAL/HHP/9710PHARMA BAVARIA INTERNATIONAL GMBH -GOODMAN INTERNATIONAL LTDHEPARESIST™XLLABO PHYTOPHAR NV-HANDELSTRAAT 19, 8020 OOSTKAMP, BELGIUM/BELGIQUE - BELGIUM BELGIUMORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER,1.0X2.0X10.0 TABLET BLISTER7/10/2021
158NDA/MAL/HHP/9711MEGA LIFESCIENCES PUBLIC COMPANY LTDABACUS PHARMA (AFRICA) LIMITEDGINSOMINMEGA LIFESCIENCES PUBLIC CO. LTD-PLANT 1; 384 MOO 4, SOI 6, BANGPOO INDUSTRIAL ESTATE, PATTANA 3 ROAD, PHRAEKSA, MUEANG, SAMUTPRAKARN 10280 THAILAND THAILANDORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER7/10/2021
159NDA/MAL/HHP/9833HEALTHCARE LTD.HEALTHCARE LTD.OSTEOCURE GELZEE LABORATORIES LTD-BEHIND 47, INDUSTRIAL AREA, PAONTA SAHIB-173025 DISTT. SIRMOUR HIMACHAL PRADESH INDIATOPICAL EXTERNAL GELS AND SOLS1.0X100.0 G TUBE26/10/2021
160NDA/MAL/HHP/9923GAYATRI AYUPHARMA PRIVATE LIMITEDVIDA AFRICA LTDCHARCO-PLUSGAYATRI AYUPHARMA PRIVATE LIMITED-234/2/2, PATEL ESTATE, NIKOL ROAD, AHMEDABAD: 382 350, GUJARAT (INDIA) INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER21/12/2021
161NDA/MAL/HHP/9928AUSHADHI WELLNESS PVT LTDMATRIX (U) LTDTEENCLEENAUSHADHI WELLNESS PVT. LTD.,RAJKOT,GUJARAT INDIA-SURVEY NO. 654,PLOT NO. 1,VILLAGE: RAVKI, TALUKA,LODHIKA, DISTRICT:RAJKOT- 360035 INDIATOPICAL EXTERNAL COMBINATION PACK CREAMS1.0X20.0 G TUBE,1.0X50.0 G TUBE21/2/2022
162NDA/MAL/HHP/9929AUSHADHI WELLNESS PVT LTDMATRIX (U) LTDHONYKOFAUSHADHI WELLNESS PVT. LTD.,RAJKOT,GUJARAT INDIA-SURVEY NO. 654,PLOT NO. 1,VILLAGE: RAVKI, TALUKA,LODHIKA, DISTRICT:RAJKOT- 360035 INDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE21/2/2022
163NDA/MAL/HHP/9930AUSHADHI WELLNESS PVT LTDMATRIX (U) LTDRAPIDCOOLAUSHADHI WELLNESS PVT. LTD.,RAJKOT,GUJARAT INDIA-SURVEY NO. 654,PLOT NO. 1,VILLAGE: RAVKI, TALUKA,LODHIKA, DISTRICT:RAJKOT- 360035 INDIATOPICAL EXTERNAL GELS AND SOLS1.0X25.0 G TUBE,1.0X50.0 G TUBE21/2/2022
NDA REGISTRATION NUMBERLICENSE HOLDERLOCAL TECHNICAL REPRESENTATIVENAME OF DRUGMANUFACTURERCOUNTRY OF MANUFACTUREDOSAGE FORMPACK SIZEREGISTRATION DATE
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
|
KENYA |OILS1.0X100.0 ML BOTTLE,1.0X250.0 ML BOTTLE7/1/2016
S/NNDA REGISTRATION NUMBERLICENSE HOLDERLOCAL TECHNICAL REPRESENTATIVENAME OF DRUGGENERIC NAME OF DRUGSTRENGTH OF DRUGMANUFACTURERCOUNTRY OF MANUFACTUREDOSAGE FORMPACK SIZEREGISTRATION DATE
1NDA/MAL/HDP/0002ABACUS PARENTERAL DRUGS LIMITED.ABACUS 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 VIAL,1.0X5.0 ML VIAL1/7/2011
2NDA/MAL/HDP/0007GITTOES PHARMACEUTICALS LIMITEDGITTOES 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 BOTTLE,1.0X200.0 ML BOTTLE1/7/2013
3NDA/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 TABLETS1.0X10.0X10.0 TABLET BLISTER1/7/2014
4NDA/MAL/HDP/0017SWISS PARENTERALS LTDSHREEJI CARE LIMITEDS-HYDROHYDROCORTISONE100MGSWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIAINDIAPARENTERAL ORDINARY DRY VIALS1.0X10.0X7.5 ML VIAL1/7/2011
5NDA/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 AMPOULE1/7/2013
6NDA/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 BLISTER1/7/1997
7NDA/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 AMPOULE1/7/2015
8NDA/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 VIAL1/7/2015
9NDA/MAL/HDP/0041RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDRECIMCIMETIDINE200MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA UGANDAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER1/7/2013
10NDA/MAL/HDP/0045GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOMOL CAPLETSPARACETAMOL500MGAGOG 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 BLISTER1/7/2007
11NDA/MAL/HDP/0051H. LUNDBECK A/SPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDCLOPIXOL ACUPHASEZUCLOPENTHIXOL ACETATE50MG/MLH. LUNDBECK A/S - OTTILIAVEJ 9,2500 VALBY DENMARKPARENTERAL ORDINARY AMPOULES1.0X1.0 ML AMPOULE1/7/2015
12NDA/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 AMPOULE1/7/2015
13NDA/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 TUBE1/7/2013
14NDA/MAL/HDP/0055H.LUNDBECK A/SPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDCLOPIXOL DEPOTZUCLOPENTHIXOL DECANOATE200MG/MLH. LUNDBECK A/S ,.,-OTTILIAVEJ 9, DK-2500, VALBY-COPENHAGEN DENMARKPARENTERAL ORDINARY AMPOULES1.0X1.0 ML AMPOULE1/7/2015
15NDA/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 BOTTLE1/7/2015
16NDA/MAL/HDP/0058ACULIFE HEALTHCARE PVT LTDASTRA PHARMA (U) 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 AMPOULE1/7/1997
17NDA/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 APPLICATOR1/7/2006
18NDA/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 S.A -SUCCURSALE D'AUBONNE, ZONE INDUSTRIELLE DE L'OURIETTAZ, 1170 AUBONNE, SWITZERLAND MERCK 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 INJECTION1/7/2015
19NDA/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 CONTAINER1/7/2015
20NDA/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 MERCK SERONO SPA (BARI)-VIA DELLE MAGNOLIE, 15 (LOC FRAZ ZONA INDUSTRIALE) 70026, MODUGNO, BARI SWITZERLANDPARENTERAL ORDINARY CARTRIDGES1.0X1.0 CARTRIDGE PREFILLED PEN + 12 NEEDLES FOR INJECTION1/7/2015
21NDA/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 BLISTER1/7/1999
22NDA/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 BLISTER,1.0X3.0X10.0 TABLET BLISTER1/7/1999
23NDA/MAL/HDP/0073NAARI LTDPHARMA VILLE 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 BLISTER1/7/2013
24NDA/MAL/HDP/0075SUN PHARMACEUTICAL INDUSTRIES LIMITEDSTAR PHARMACEUTICALS LTDSYNRIAMARTEROLANE MALEATE + PIPERAQUINE PHOSPHATE150 MG + 750 MGSUN PHARMACEUTICAL INDUSTRIES LIMITED -INDUSTRIAL AREA 3, A.B. ROAD, DEWAS 455001, MADHYA PRADESH, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0 TABLET BLISTER1/7/2014
25NDA/MAL/HDP/0077ABACUS PARENTERAL DRUGS LIMITEDABACUS 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 VIAL1/7/2015
26NDA/MAL/HDP/0079MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDREVOKE 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 BLISTER1/7/2014
27NDA/MAL/HDP/0088GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDD-LYTE CO-PACKANHYDROUS GLUCOSE+SODIUM CHLORIDE+TRISODIUM CITRATE+POTASSIUM CHLORIDE/ZINC,ANHYDROUS GLUCOSE+SODIUM CHLORIDE+TRISODIUM CITRATE+POTASSIUM CHLORIDE/ZINC,ANHYDROUS GLUCOSE+SODIUM CHLORIDE+TRISODIUM CITRATE+POTASSIUM CHLORIDE/ZINC2.7MG+0.52MG+0.58MG+0.30MG+20MG PER 200ML,6.75MG+1.30MG+1.45MG+0.75MG+20MG PER 500ML SACHET,13.5MG+2.60MG+2.90MG+1.50MG+20MG PER 1000ML SACHETAGOG 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 BLISTERS1/7/2015
28NDA/MAL/HDP/0097MSN LABORATORIES LTDMETRO PHARMACEUTICALS LIMITEDSAFELEVO 750LEVOFLOXACIN750MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER1/7/2013
29NDA/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 BLISTER1/7/2013
30NDA/MAL/HDP/0101GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOTETRA CAPSULESTETRACYCLINE 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 BLISTER1/7/1998
31NDA/MAL/HDP/0102MSN LABORATORIES PRIVATE LIMITEDMETRO 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 BLISTER1/7/2014
32NDA/MAL/HDP/0103MSN LABORATORIES PRIVATE LIMITEDMETRO PHARMACEUTICALS LIMITEDATOREM 20ATORVASTATIN20MGMSN LABORATORIES LTD- PLOT N0.42, ANRICH INDUSTRIAL ESTATE INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER1/7/2013
33NDA/MAL/HDP/0104MSN LABORATORIES PRIVATE LIMITEDMETRO PHARMACEUTICALS LIMITEDSILMELT 50SILDENAFIL CITRATE50MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY TABLETS1.0X2.0X2.0 TABLET BLISTER1/7/2014
34NDA/MAL/HDP/0105GITTOES PHARMACEUTICALS 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 CONTAINER1/7/1998
35NDA/MAL/HDP/0107NVS KENYA LTDSURGIPHARM (U) LIMITEDASUNRADEFERASIROX400MGNOVARTIS PHARMA STEIN AG-H-4332 STEIN SCHAFFAUSERTRASSESWITZERLANDORAL SOLID ORDINARY SOLUBLE TABLETS1.0X5.0X6.0 TABLET BLISTER1/7/2015
36NDA/MAL/HDP/0110MSN LABORATORIES PRIVATE LIMITEDABACUS PHARMA (AFRICA) LIMITEDSAFETELMI 40TELMISARTAN40MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER1/7/2013
37NDA/MAL/HDP/0111MSN LABORATORIES PRIVATE LIMITEDABACUS PHARMA (AFRICA) LIMITEDSAFETELMI 80TELMISARTAN80MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER1/7/2013
38NDA/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 BLISTER1/7/2007
39NDA/MAL/HDP/0114MSN LABORATORIES PRIVATE LIMITEDMETRO 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 BLISTER1/7/2013
40NDA/MAL/HDP/0116MSN LABORATORIES PRIVATE LIMITEDMETRO 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 BLISTER1/7/2013
41NDA/MAL/HDP/0117ALKEM LABORATORIES LIMITEDABACUS PHARMA (AFRICA) LIMITEDZOCEF 1.5GCEFUROXIME SODIUM1.5GALKEM LABORATORIES LTD-VILLAGE – THANA, BADDI TEHSIL – NALAGARH, DIST-SOLAN (HP), INDIA – 173205 SANCE LABORATORIES PVT LTD-VI/51B, P.B. NO.2, KOZHUVANAL, PALA, KOTTAYAM DISTRICT-686573, KERALA, INDIA. INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0X1.5 G VIAL + 1 AMPOULE OF WFI1/7/2013
42NDA/MAL/HDP/0118ALKEM LABORATORIES LIMITEDABACUS PHARMA (AFRICA) LIMITEDZOCEF 750MGCEFUROXIME SODIUM750MGALKEM LABORATORIES LTD-VILLAGE – THANA, BADDI TEHSIL – NALAGARH, DIST-SOLAN (HP), INDIA – 173205 SANCE LABORATORIES PVT LTD-VI/51B, P.B. NO.2, KOZHUVANAL, PALA, KOTTAYAM DISTRICT-686573, KERALA, INDIA. INDIAPARENTERAL ORDINARY DRY VIALS1.0X750.0 MG VIAL + 1 AMPOULE WFI1/7/2013
43NDA/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 BLISTER1/7/2013
44NDA/MAL/HDP/0121SHELYS PHARMACEUTICALS LTDBETA HEALTHCARE UGANDA LIMITEDPEDZINCZINC SULPHATE20MGBETA HEALTH CARE INTERNATIONAL LIMITED/-PLOT NO. LR 209/ 6534 MOGADISHU ROAD, KENYA KENYAORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER1/7/2015
45NDA/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 BOTTLE1/7/2015
46NDA/MAL/HDP/0125DAWA LIMITEDSUPER MEDIC LTDSULPHUR OINTMENTSULPHUR10%W/WDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYATOPICAL EXTERNAL OINTMENTS1.0X20.0 G TUBE1/7/2013
47NDA/MAL/HDP/0127DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDCORYCARDONIRBESARTAN + HYDROCHLOROTHIAZIDE300MG + 12.5MGDELORBIS PHARMACEUTICALS LTD-17, ATHINON STREET, ERGATES INDUSTRIAL AREA, 2643 ERGATES P.O. BOX 28629, 2081 LEFKOSIA CYPRUSORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER1/7/2013
48NDA/MAL/HDP/0128DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDCORYCARDONIRBESARTAN + HYDROCHLOROTHIAZIDE150MG + 12.5MGDELORBIS PHARMACEUTICALS LTD-17, ATHINON STREET, ERGATES INDUSTRIAL AREA, 2643 ERGATES P.O. BOX 28629, 2081 LEFKOSIA CHINAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER1/7/2013
49NDA/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 BLISTER1/7/1998
50NDA/MAL/HDP/0135SHELYS PHARMACEUTICALS LTDBETA HEALTHCARE UGANDA LIMITEDHEMOVIT SYRUPIRON + FOLIC ACID + PYRIDOXINE + CYANOCOBALAMIN + ZINC200MG + 1.5MG + 0.5MG + 50 MCG + 2.33MGBETA HEALTHCARE INTERNATIONAL LTD -PLOT NO LR 209/6534 MOGADISHU ROADKENYAORAL LIQUID ORDINARY SYRUPS1.0X200.0 ML BOTTLE1/7/2013
51NDA/MAL/HDP/0139DAWA LIMITED-SUPER MEDIC LTDMOXAFORTEFLUCLOXACILLIN SODIUM + AMOXICILLIN TRIHYDRATE250MG + 250MGDAWA PHARMACEUTICALS LIMITED-PLOT 7879, BABA DOGO ROAD RUARAKA KENYAORAL SOLID ORDINARY CAPSULES1.0X2.0X10.0 CAPSULE BLISTER1/7/2014
52NDA/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 BOTTLE1/7/1998
53NDA/MAL/HDP/0152DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDRYCARDON 150IRBESARTAN150MGDELORBIS PHARMACEUTICALS LTD-17 ATHINON STR., ERGATES INDUSTRIAL AREA, 2643 ERGATES, P.O. BOX 28629, 2081 LEFKOSIA, CYPRUS CYPRUSORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER1/7/2013
54NDA/MAL/HDP/0153DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDRYCARDON 300IRBESARTAN300MGDELORBIS PHARMACEUTICALS LTD-17 ATHINON STR., ERGATES INDUSTRIAL AREA, 2643 ERGATES, P.O. BOX 28629, 2081 LEFKOSIA, CYPRUS CYPRUSORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER1/7/2013
55NDA/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 BLISTER1/7/2013
56NDA/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 BOTTLE1/7/2015
57NDA/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 BOTTLE1/7/2015
58NDA/MAL/HDP/0163RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDPHENARENPROMETHAZINE HYDROCHLORIDE5MG/5MLRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA UGANDAORAL LIQUID ORDINARY SYRUPS1.0X60.0 ML BOTTLE1/7/2015
59NDA/MAL/HDP/0164RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDRENPRESSPROPRANOLOL40MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA UGANDAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER1/7/2014
60NDA/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 BLISTER1/7/2013
61NDA/MAL/HDP/0166RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDX-PELMEBENDAZOLE100MG/5MLRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA UGANDAORAL LIQUID ORDINARY SUSPENSIONS1.0X30.0 ML BOTTLE1/7/2015
62NDA/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 BLISTER1/7/2013
63NDA/MAL/HDP/0168MSN LABORATORIES PRIVATE LIMITEDMETRO PHARMACEUTICALS LIMITEDFEBUDAYFEBUXOSTAT80MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER1/7/2014
64NDA/MAL/HDP/0175BAYER SCHERING PHARMASURGIPHARM (U) LIMITEDXARELTO 10MGRIVAROXABAN10MGBAYER HEALTHCARE AG,-D-51368, LEVERKUSEN GERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X10.0 TABLET BLISTER1/7/2009
65NDA/MAL/HDP/0182MSN LABORATORIES PRIVATE LIMITEDMETRO 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 BLISTER1/7/2014
66NDA/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 BOTTLE1/7/2014
67NDA/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 BLISTER1/7/2014
68NDA/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 BOTTLE1/7/2013
69NDA/MAL/HDP/0193MEDOPHARM, INDIAPLANET 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 BLISTER,1.0X2.0X10.0 TABLET STRIP1/7/2013
70NDA/MAL/HDP/0196CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDCIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDLAMIVUDINE AND ZIDOVUDINE TABLETSLAMIVUDINE/ZIDOVUDINE150MG/300MGCIPLA QUALITY CHEMICAL INDUSTRIES LIMITED - -PLOT 1-7 1ST RING ROAD, LUZIRA, KAMPALA UGANDAORAL SOLID ORDINARY OTHER COATED TABLETS1.0X60.0 TABLET CONTAINER1/7/2013
71NDA/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 CANNISTER1/7/2015
72NDA/MAL/HDP/0204GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDTIVICAYDOLUTEGRAVIR SODIUM50MGGLAXO OPERATIONS UK LTD-WARE SG120DJ UNITED KINGDOM GLAXOSMITHKLINE PHARMACEUTICALS SA-GRUNWALDZKA 189 STREET, 60-322 POZNANA UNITED KINGDOMORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET CONTAINER1/7/2015
73NDA/MAL/HDP/0205MACLEODS PHARMACEUTICALS LTDS LTDVITACARE 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 BOTTLE1/7/2013
74NDA/MAL/HDP/0207MACLEODS PHARMACEUTICALS LTDVITACARE 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 BOTTLE1/7/2013
75NDA/MAL/HDP/0209HETERO LABS LTDAIVEEN (U) LIMITEDABACAVIR SULPHATE ORAL SOLUTIONABACAVIR SULPHATE20MG/MLHETERO LABS PRIVATE LIMITED UNIT III-SURVEY NO. 51, PLOT 22-110, INDUSTRIAL DEVELOPMENT AREA (I.D.A) JEEDIMETLA, HYDERABAD-500 055, TELANGANA STATE INDIAORAL LIQUID ORDINARY LIQUIDS1.0X240.0 ML BOTTLE1/7/2013
76NDA/MAL/HDP/0213AUROBINDO PHARMA LTD (UNIT VI)PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDAUROPODOX 200CEFPODOXIME200MGAUROBINDO PHARMA LIMITED, UNIT III-SURVEY NO. 313 & 314, BACHUPALLY (MANDAL), MEDCHAL - MALKAJGIRI (DISTRICT) - 500090 TELENGANA (STATE) INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER1/7/2013
77NDA/MAL/HDP/0217PHARMACIE BETHELABACUS 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 AMPOULE1/7/2014
78NDA/MAL/HDP/0218PHARMACIE BETHELABACUS PARENTERAL DRUGS LIMITEDTENOL-100ATENOLOL100MGLINCOLN 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 BLISTER1/7/2015
79NDA/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 BLISTER1/7/2013
80NDA/MAL/HDP/0222ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDAVIR-200ACYCLOVIR500MGLINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT S KANT HEALTHCARE LIMITED-1802 – 1805, G.I.D.C., PHASE III, VAPI -396195 GUJARAT, INDIA. INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER1/7/2013
81NDA/MAL/HDP/0230STRIDES SHASUN LIMITEDDELMAW ENTERPRISES LIMITEDCOMBIARTARTHEMETHER + LUMEFANTRINE20MG +120MGSTRIDES PHARMA SCIENCE LIMITED (STRIDES SHASUN)-KRS GARDENS, PLOT 36/7 SURAGAJKKANAHALLI, INDLAWADI CROSS, ANKAL TALUK, BANGALORE SOUTH - 562106, INDIA 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 BLISTER,1.0X30.0X18.0 TABLET BLISTER,1.0X30.0X24.0 TABLET BLISTER1/7/2013
82NDA/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 BLISTER1/7/2013
83NDA/MAL/HDP/0233MEDOCHEMIE LTDLABOREX UGANDA 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 BLISTER1/7/2014
84NDA/MAL/HDP/0234MEDOCHEMIE LTDLABOREX UGANDA 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 BLISTER1/7/2014
85NDA/MAL/HDP/0235MEDOCHEMIE LTDLABOREX UGANDA LIMITEDAXETINE 500CEFUROXIME AXETIL500MGMEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY.-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA CYPRUSORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET STRIP1/7/2014
86NDA/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 BLISTER,1.0X6.0 TABLET BLISTER,1.0X2.0X6.0 TABLET BLISTER1/7/2014
87NDA/MAL/HDP/0244SAKAR HEALTHCARE PVT LTDROYAL PHARMA 2011 LIMITEDHYOCINHYOSCINE BUTYLBROMIDE20MG/MLSAKAR HEALTHCARE PVT LTD-BLOCK NO. 10-13, NR. M.N DESAI PETRO PUMP, SARKHEJ-BAVLA ROAD, CHANGODAR, DIST: AHMEDABAD-382213, GUJARAT INDIAPARENTERAL ORDINARY AMPOULES1.0X2.0X5.0X1.0 ML AMPOULE1/7/2014
88NDA/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 BLISTER1/7/2014
89NDA/MAL/HDP/0248IPCA LABORATORIES LTDMEDVIN PHARMA LIMITEDPANTONEX DR-40PANTOPRAZOLE40 MG IPCA LABORATORIES LTD-PLOT NO. 255/1,
VILLAGE ATHAL,
SILVASSA-396230,
DADRA AND NAGAR HAVELI, INDIA.
INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER1/7/2013
90NDA/MAL/HDP/0250ABACUS PARENTERAL DRUGS LIMITEDABACUS 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 CONTAINER1/7/2013
91NDA/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 BLISTER1/7/2014
92NDA/MAL/HDP/0253ABACUS PARENTERAL DRUGS LIMITEDABACUS PHARMA (AFRICA) LIMITEDTENLOW-5AMLODIPINE BESYLATE5MGLINCO N PHARMACEUTICALS LIMITED-TRIMUL ESTATE KHATRAJ KALOL GUJARAT INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER1/7/2013
93NDA/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 BLISTER1/7/2013
94NDA/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 CARTON1/7/2001
95NDA/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
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER1/7/2014
96NDA/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 BLISTER1/7/2013
97NDA/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)1/7/2015
98NDA/MAL/HDP/0275GLAXO SMITHLINE LIMITEDUNITED HEALTHCARE DISTRIBUTORS LTDZENTELALBENDAZOLE400MGGLAXOSMITHKLINE CONSUMER HEALTHCARE S.A (PTY) LIMITED-39 HAWKINS AVENUE, EPPING INDUSTRIA 1, 7460, CAPE TOWN, SOUTH AFRICA SOUTH AFRICAORAL SOLID ORDINARY CHEWABLE TABLETS1.0X1.0 TABLET BLISTER1/7/2011
99NDA/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 BLISTER1/7/2013
100NDA/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 BLISTER1/7/1998
101NDA/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 BOTTLE1/7/2013
102NDA/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 TUBE1/7/2013
103NDA/MAL/HDP/0290LABORATORY & 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 CONTAINER,1.0X10.0X10.0 TABLET BLISTER1/7/1997
104NDA/MAL/HDP/0293HETERO LABS LTDAIVEEN (U) LIMITEDDARUNAVIRDARUNAVIR600 MGHETERO LABS LTD-22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESHINDIAORAL SOLID ORDINARY TABLETS1.0X60.0 TABLET BOTTLE1/7/2014
105NDA/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 BLISTER,1.0X10.0X10.0 TABLET BLISTER1/7/1998
106NDA/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 BOTTLE1/7/2013
107NDA/MAL/HDP/0301HETERO LABS LTDAIVEEN (U) LIMITEDMONAST 10MONTELUKAST SODIUM10MGHETERO 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 BLISTER1/7/2013
108NDA/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 CONTAINER1/7/2014
109NDA/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 BOTTLE1/7/2013
110NDA/MAL/HDP/0307HETERO DRUGS LTDAIVEEN (U) LIMITEDLAMIVUDINE ORAL SOLUTIONLAMIVUDINE10MG/MLHETERO DRUGS LTD, UNIT III -22-110, IDA, JEEDIMETLA INDIAORAL LIQUID ORDINARY SOLUBLE POWDERS1.0X240.0 ML CONTAINER1/7/2013
111NDA/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 BLISTER1/7/2013
112NDA/MAL/HDP/0311MARTINDALE PHARMACEUTICALS LTDLABOREX UGANDA LIMITEDFENTANYLFENTANYL CITRATE50MCG/MLMARTINDALE PHARMACEUTICAL LIMITED -BAMPTON ROAD RMM38UG ENGLANDUNITED KINGDOMPARENTERAL ORDINARY AMPOULES1.0X10.0X2.0 ML AMPOULE1/7/2013
113NDA/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 BOTTLE1/7/2013
114NDA/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 AMPOULE1/7/2013
115NDA/MAL/HDP/0318DAWA LIMITEDSUPER MEDIC LTDSABULINSALBUTAMOL4MGDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER1/7/2013
116NDA/MAL/HDP/0320DAWA LIMITEDSUPER MEDIC LTDDAZOLECLOTRIMAZOLE1%W/WDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYATOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE1/7/2013
117NDA/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 BLISTER1/7/2009
118NDA/MAL/HDP/0327GLENMARK PHARMACUTICALS LTDSTAR PHARMACEUTICALS LTDFLEXILOR 8LORNOXICAM8MGGLENMARK PHARMACEUTICAL LIMITED;--VILLAGE KISHANPURA,BADDI-NALAGARH ROAD TEHSIL BADDI,DISTT. SOLAN, HIMACHAL PRADESH -174 101 INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER1/7/2014
119NDA/MAL/HDP/0331AUROBINDO PHARMA LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDLEVOKILZ 500LEVOFLOXACIN500MGAUROBINDO PHARMA LTD UNIT VII (SEZ) APIIC-PLOT NO. S1 SURVEY NO. 411,425,434,435 & 458 GREEN INDUSTRIAL PARK POLEPALLY VILLAGE MAHABOOBNAGAR DISTRICT ANDHRA PRADESH INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER1/7/2014
120NDA/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 BLISTER1/7/2014
121NDA/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 TUBE1/7/2013
122NDA/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 BLISTER1/7/2014
123NDA/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 BLISTER1/7/2014
124NDA/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 TUBE1/7/2013
125NDA/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 BLISTER,1.0X3.0X10.0 TABLET BLISTER1/7/2014
126NDA/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 BLISTER,3.0X10.0 TABLET BLISTER1/7/2014
127NDA/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 TUBE1/7/2013
128NDA/MAL/HDP/0348ABACUS PARENTERAL DRUGS LIMITEDABACUS 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 VIAL,1.0X5.0 ML VIAL1/7/2015
129NDA/MAL/HDP/0349SWISS PARENTERALS PVT LTDSHREEJI CARE 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 VIAL1/7/2013
130NDA/MAL/HDP/0350RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDCETRIRENCETIRIZINE HYDROCHLORIDE10MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA UGANDAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER1/7/2015
131NDA/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 BLISTER1/7/2014
132NDA/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 BLISTER1/7/2013
133NDA/MAL/HDP/0355SWISS PARENTERALS LTDSHREEJI CARE 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 AMPOULE1/7/2015
134NDA/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 BLISTER1/7/2014
135NDA/MAL/HDP/0358SWISS PARENTERALS LTDSHREEJI CARE LIMITEDSTREPTOCINSTREPTOMYCIN SULPHATE1GMSWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIAINDIAPARENTERAL ORDINARY I M VIALS1.0X1.0 G VIAL1/7/2014
136NDA/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 CARTON1/7/2001
137NDA/MAL/HDP/0362SWISS PARENTERALS LTDSHREEJI CARE LIMITEDBUPIBUPIVACAINE5 MG/MLSWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIAINDIAPARENTERAL ORDINARY VIALS1.0X20.0 ML VIAL1/7/2015
138NDA/MAL/HDP/0363BLISS GVS PHARMA LIMITEDMEDVIN PHARMA 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 BLISTER1/7/2014
139NDA/MAL/HDP/0366BLISS GVS PHARMA LIMITEDMEDVIN PHARMA 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 BLISTER1/7/2014
140NDA/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 BLISTER1/7/2010
141NDA/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 BLISTER1/7/2009
142NDA/MAL/HDP/0373MEDOCHEMIE LTDLABOREX UGANDA LIMITEDTEMELINCETIRIZINE HYDROCHLORIDE10MGMEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY.-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA CYPRUSORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER1/7/2013
143NDA/MAL/HDP/0375MEDOCHEMIE LTDLABOREX UGANDA LIMITEDFENAMON SRNIFEDIPINE20MGMEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY.-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA CYPRUSORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X10.0 TABLET BLISTER1/7/2014
144NDA/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 BLISTER1/7/2014
145NDA/MAL/HDP/0380MEDOCHEMIE LTDLABOREX UGANDA LIMITEDAVERNOLCARVEDILOL6.25NGMEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY.-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA CYPRUSORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER1/7/2014
146NDA/MAL/HDP/0382FRESENIUS KABI MANUFACTURING S.A (PTY) LTDSURGIPHARM (U) LIMITEDKETAMINE FRESENIUSKETAMINE HYDROCHLORIDE50MG/MLFRESENIUS KABI MANUFACTURING SA (PTY) LTD-6 GIBAUD ROAD, KORSTEN 6020, PORT ELIZABETH SOUTH AFRICAPARENTERAL ORDINARY VIALS1.0X10.0X10.0 ML VIAL1/7/2014
147NDA/MAL/HDP/0383FRESENIUS KABI MANUFACTURING S.A (PTY) LTDSURGIPHARM (U) LIMITEDMANNITOL FRESENIUSMANNITOL20%W/VFRESENIUS KABI MANUFACTURING SA (PTY) LTD-6 GIBAUD ROAD, KORSTEN 6020, PORT ELIZABETH SOUTH AFRICAPARENTERAL ORDINARY INFUSION BAGS1.0X500.0 ML BAG1/7/2014
148NDA/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 SYRINGE1/7/2014
149NDA/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 BLISTER1/7/1997
150NDA/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 BOTTLE1/7/2014
151NDA/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 BLISTER1/7/2013
152NDA/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 BLISTER1/7/2013
153NDA/MAL/HDP/0403NEON LABARATORIES LTD.NORVIK ENTERPRISES 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 AMPOULE1/7/2013
154NDA/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 JERRYCAN1/7/1997
155NDA/MAL/HDP/0406NEON LABARATORIES LTD.NORVIK ENTERPRISES 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 AMPOULE1/7/2015
156NDA/MAL/HDP/0407NEON LABARATORIES LTD.NORVIK ENTERPRISES 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 VIALS1.0X20.0 ML VIAL1/7/2013
157NDA/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 BLISTER1/7/2013
158NDA/MAL/HDP/0409NEON LABARATORIES LTD.NORVIK ENTERPRISES 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 VIAL1/7/2013
159NDA/MAL/HDP/0410MSN LABORATORIES PRIVATE LIMITEDABACUS PHARMA (AFRICA) LIMITEDLDNIL 20ROSUVASTATIN CALCIUM20MGMSN LABORATORIES LTD- PLOT N0.42, ANRICH INDUSTRIAL ESTATE INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER1/7/2013
160NDA/MAL/HDP/0411BAYER PHARMA AGSURGIPHARM (U) LIMITEDJADELLE SINELEVONORGESTREL150MGBAYER OY-PANSIONATE 47 20210 TURKU FINLANDFINLANDPARENTERAL RETARD IMPLANTS1.0X10.0X1.0X2.0X75.0 MG IMPLANT1/7/2003
161NDA/MAL/HDP/0413NEON LABARATORIES LTD.NORVIK ENTERPRISES 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 AMPOULE1/7/2013
162NDA/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 BOTTLE1/7/1997
163NDA/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 BOTTLE,1.0X4.0X7.0 TABLET BLISTER1/7/2013
164NDA/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 BOTTLE1/7/2013
165NDA/MAL/HDP/0421MSN LABORATORIES PRIVATE LIMITEDMETRO PHARMACEUTICALS LIMITEDPREGASAFE 150PREGABALIN150MGMSN LABORATORIES LTD-PLOT NO.42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, INDIA INDIAORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER1/7/2014
166NDA/MAL/HDP/0422GITTOES PHARMACEUTICALS LIMITEDGITTOES 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 BOTTLE1/7/2013
167NDA/MAL/HDP/0423GITTOES PHARMACEUTICALS 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 BLISTER1/7/2013
168NDA/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 BLISTER1/7/1998
169NDA/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 BLISTER1/7/2015
170NDA/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 BLISTER1/7/2013
171NDA/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 TABLETS10.0X1.0X10.0 TABLET BLISTER,1.0X10.0X1.0X10.0 TABLET BLISTER1/7/2014
172NDA/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 BLISTER1/7/2013
173NDA/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 AMPOULE1/7/2014
174NDA/MAL/HDP/0434LEBEN LABORATORIES PVT LTDMALIX PHARMA (U) LIMITEDPROHIBINGASTRO-RESISTANT OMEPRAZOLE CAPSULES BP 2020 MGLEBEN 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 STRIP1/7/2010
175NDA/MAL/HDP/0435FRESENIUS KABI MANUFACTURING S.A (PTY) LTDSURGIPHARM (U) LIMITEDLIGNOCAINE HCL FRESENIUSLIGNOCAINE HYDROCHLORIDE2%W/VFRESENIUS KABI MANUFACTURING SA (PTY) LTD-6 GIBAUD ROAD, KORSTEN 6020, PORT ELIZABETH SOUTH AFRICAPARENTERAL ORDINARY VIALS1.0X10.0X20.0 ML VIAL1/7/2015
176NDA/MAL/HDP/0437FRESENIUS KABI SOUTH AFRICA (PTY) LIMITEDSURGIPHARM (U) LIMITEDNALOXONE HCL NEONATAL FRESENIUSNALOXONE HYDROCHLORIDE0.02MG/MLFRESENIUS KABI MANUFACTURING SA (PTY) LTD-6 GIBAUD ROAD, KORSTEN 6020, PORT ELIZABETH SOUTH AFRICAPARENTERAL ORDINARY AMPOULES1.0X10.0X2.0 ML AMPOULE1/7/2014
177NDA/MAL/HDP/0439FRESENIUS KABI SOUTH AFRICA (PTY) LIMITEDSURGIPHARM (U) LIMITEDNALOXONE HCL FRESENIUS 0.4MG/1MLNALOXONE HYDROCHLORIDE0.4MG/1MLFRESENIUS KABI MANUFACTURING SA (PTY) LTD-6 GIBAUD ROAD, KORSTEN 6020, PORT ELIZABETH SOUTH AFRICAPARENTERAL ORDINARY AMPOULES1.0X10.0X1.0 ML AMPOULE1/7/2015
178NDA/MAL/HDP/0442PHARMACIE BETHELABACUS PARENTERAL DRUGS LIMITEDZIK-ZAK-50SILDENAFIL CITRATE50MGLINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT INDIAORAL SOLID ORDINARY TABLETS1.0X4.0 TABLET BLISTER1/7/2014
179NDA/MAL/HDP/0444FRESENIUS KABI MANUFACTURING S.A (PTY) LTDSURGIPHARM (U) LIMITEDNEOSTIGMINE METHYLSUIPHATE FRESENIUSNEOSTIGMINE METHYLSULPHATE2.5MG\MLFRESENIUS KABI MANUFACTURING SA (PTY) LTD-6 GIBAUD ROAD, KORSTEN 6020, PORT ELIZABETH SOUTH AFRICAPARENTERAL ORDINARY AMPOULES1.0X10.0X1.0 ML AMPOULE1/7/2015
180NDA/MAL/HDP/0447PT SANBE FARMAMEDVIN PHARMA LIMITEDSANEXON®125METHYLPREDNISOLONE SODIUM SUCCINATE125MG/VIALPT. SANBE FARMA STERILE PREPARATION PLANT - (UNIT 3)-JALAN INDUSTRI CIMAREME NO. 8 DESA CIMAREME, KECAMATAN PADALARANG, KABUPATEN BANDUNG BARAT 40553 - INDONESIAINDONESIAPARENTERAL ORDINARY DRY VIALS1.0X125.0 MG VIAL + 1*2ML AMPOULE OF WFI1/7/2014
181NDA/MAL/HDP/0449PRISMA PHARMA FZEPHILLIPS 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 SACHET1/7/2013
182NDA/MAL/HDP/0451PT SANBE FARMAMEDVIN PHARMA LIMITEDSANEXON®500METHYLPREDNISOLONE SODIUM SUCCINATE500MG/VIALPT. SANBE FARMA STERILE PREPARATION PLANT - (UNIT 3)-JALAN INDUSTRI CIMAREME NO. 8 DESA CIMAREME, KECAMATAN PADALARANG, KABUPATEN BANDUNG BARAT 40553 - INDONESIAINDONESIAPARENTERAL ORDINARY DRY VIALS1.0X500.0 MG VIAL + 1*8ML AMPOULE OF WFI1/7/2014
183NDA/MAL/HDP/0453PRISMA PHARMA FZEPHILLIPS 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 BOTTLE1/7/2013
184NDA/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 BOTTLE1/7/2014
185NDA/MAL/HDP/0456LEBEN LABORATORIES PVT. LTDMALIX PHARMA (U) LIMITEDMETROLEBMETRONIDAZOLE125MG/5MLLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE1/7/2014
186NDA/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 BLISTER1/7/2012
187NDA/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 BOTTLE1/7/2009
188NDA/MAL/HDP/0463GITTOES PHARMACEUTICALS LIMITEDGITTOES 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 BLISTER1/7/2011
189NDA/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 STRIP1/7/1997
190NDA/MAL/HDP/0470NOVO NORDISK PHARMA GULF FZ-LCPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDNOVOMIX 30 FLEXPENINSULIN ASPART100I.U/MLNOVO NORDISK A/S - NOVO ALLE DK-2880 BAGSVAERD NOVO NORDISK PRODUCTION SAS-45 AVENUE D’ORLEANS, 28000 CHARTRES, FRANCE NOVO NORDISK PRODUCAO FARMACEUTICA DO BRASIL LTDA-AV. "C", 1413, DISTRITO INDUSTRIAL - 390404 004 MONTES CLAROS, MINAS GERAIS - BRAZIL DENMARKPARENTERAL ORDINARY DRY PRE-FILLED PENS1.0X5.0X3.0 ML PREFILLED PEN1/7/2014
191NDA/MAL/HDP/0471NOVO NORDISK PHARMA GULF FZ-LCPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDNOVORAPID FLEXPENINSULIN ASPART100 I.U/MLNOVO NORDISK A/S - NOVO ALLE DK-2880 BAGSVAERD NOVO NORDISK PRODUCTION SAS-45 AVENUE D’ORLEANS, 28000 CHARTRES, FRANCE NOVO NORDISK PRODUCAO FARMACEUTICA DO BRASIL LTDA-AV. "C", 1413, DISTRITO INDUSTRIAL - 390404 004 MONTES CLAROS, MINAS GERAIS - BRAZIL DENMARKPARENTERAL ORDINARY PRE-FILLED PENS1.0X5.0X3.0 ML PREFILLED PEN1/7/2014
192NDA/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 VIAL1/7/2015
193NDA/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 BLISTER1/7/2015
194NDA/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 BLISTER1/7/2014
195NDA/MAL/HDP/0482LEBEN LABORATORIES PVT. LTDMALIX PHARMA (U) LIMITEDAZILEB-500AZITHROMYCIN500MGLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X20.0X3.0 TABLET BLISTER1/7/2014
196NDA/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 STRIP1/7/2013
197NDA/MAL/HDP/0489LEBEN LABORATORIES PVT.LTDMALIX PHARMA (U) LIMITEDCEBAY-200 DTCEFIXIME200MGLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL SOLID ORDINARY SOLUBLE TABLETS1.0X10.0 TABLET BLISTER1/7/2014
198NDA/MAL/HDP/0491ABACUS PARENTERAL DRUGS LIMITEDABACUS 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 VIAL1/7/2013
199NDA/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 BOTTLE1/7/1997
200NDA/MAL/HDP/0499NVS KENYA LTDSURGIPHARM (U) LIMITEDBANEOCIN OINTMENTBACITRACIN ZINC+NEOMYCIN SULPHATE250I.U + 5000I.ULEK PHARMACEUTICALS DD-VEROVSKOVA 57, SI-1526 LJUBLJANA MERCK KGAA & CO.-HOSSLGASSE 20 9800 SPITTAL DRAU/ AUSTRIA SLOVENIA AUSTRIATOPICAL EXTERNAL OINTMENTS1.0X20.0 G TUBE1/7/2014
201NDA/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 BOTTLE1/7/2013
202NDA/MAL/HDP/0506REMINGTON PHARMACEUTICAL INDUSTRIES PVT LTDHEALTHCARE LTD.OPTA-ATROPINE EYE DROPSATROPINE SULPHATE1%W/VREMINGTON PHARMACEUTICAL INDUS. PVT LTD-, 117 ALLAM PAKISTANOPHTHALMIC DROPS1.0X10.0 ML VIAL1/7/2001
203NDA/MAL/HDP/0510GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDLIZOLID-600LINEZOLID600MGGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D INDIAORAL SOLID ORDINARY TABLETS1.0X5.0X4.0 TABLET STRIP1/7/2004
204NDA/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 STRIP1/7/2014
205NDA/MAL/HDP/0521ALKEM LABORATORIES LIMITEDABACUS PHARMA (AFRICA) LIMITEDPAN 40PANTOPRAZOLE SODIUM40MGALKEM LABORATORIES LTD .- VILLAGE THANA BADDI TEHSIL NALAGARH DIST SOLAN HIMACHAL PRADESH EAST AFRICAN (INDIA) OVERSEAS-PLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIA INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER1/7/2014
206NDA/MAL/HDP/0526LEBEN LABORATORIES LTDMALIX PHARMA (U) LIMITEDAMILEB- 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 BLISTER1/7/2014
207NDA/MAL/HDP/0531LEBEN LABORATORIES LTDMALIX PHARMA (U) LIMITEDENDERM-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 TUBE1/7/2014
208NDA/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 VIAL1/7/2014
209NDA/MAL/HDP/0542DAWA LIMITEDSUPER MEDIC LTDPHENBITALPHENOBARBITAL30MGDAWA LTD-BABA DOGO ROAD RUARAKAKENYAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER1/7/2014
210NDA/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 BLISTER1/7/2013
211NDA/MAL/HDP/0547NAARI LTDUNITED HEALTHCARE DISTRIBUTORS LTDMISO-KAREMISOPROSTOL200MCGNAARI PHARMA PRIVATE LIMITED-PLOT NO. 14-16 &55-57, SECTOR-5, IIE, PANTNAGAR, RUDRAPUR-263153, DIST. U.S. NAGAR, UTTARAKHAND, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X5.0 TABLET BLISTER (COMBIPACK),1.0X3.0X4.0 TABLET BLISTER1/7/2013
212NDA/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 BLISTER1/7/2012
213NDA/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 BLISTER1/7/2014
214NDA/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 CONTAINER1/7/2014
215NDA/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 CARTON1/7/2014
216NDA/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)1/7/2013
217NDA/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 CARTON1/7/2014
218NDA/MAL/HDP/0558ABACUS PARENTERAL DRUGS LIMITEDABACUS 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 BOTTLE,1.0X5.0 ML VIAL1/7/2014
219NDA/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 BLISTER1/7/2013
220NDA/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 BLISTER1/7/2013
221NDA/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 BOTTLE1/7/2013
222NDA/MAL/HDP/0568RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDFLUOXIRENFLUOXETINE20MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA UGANDAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER1/7/2013
223NDA/MAL/HDP/0569ABACUS PHARMA (A) LTD.ABACUS 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 BOTTLE1/7/2014
224NDA/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)1/7/2013
225NDA/MAL/HDP/0571ABACUS PHARMA (A) LTD.ABACUS 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 BOTTLE1/7/2015
226NDA/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 VIAL1/7/2010
227NDA/MAL/HDP/0573ABACUS PHARMA (A) LTD.ABACUS 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 BOTTLE1/7/2014
228NDA/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 BLISTER1/7/2013
229NDA/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 CONTAINER1/7/2015
230NDA/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 BLISTER1/7/1997
231NDA/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 BLISTER1/7/2015
232NDA/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 BLISTER1/7/2014
233NDA/MAL/HDP/0587CADILA PHARMACEUTICALS LIMITEDPLANET PHARMACEUTICALS UGANDA LTDCADIGRELCLOPIDOGREL75MGCADILA PHARMACEUTICALS LIMITED-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER1/7/2013
234NDA/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 BOTTLE1/7/2013
235NDA/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 BLISTER1/7/2014
236NDA/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 CONTAINER1/7/2013
237NDA/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 STRIP1/7/2014
238NDA/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 BLISTER1/7/2015
239NDA/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 BLISTER1/7/2003
240NDA/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 BLISTER1/7/2013
241NDA/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 BLISTER1/7/2015
242NDA/MAL/HDP/0604DAWA PHARMACEUTICALS LIMITEDSUPER MEDIC LTD-MBARARATRIMOXOLCO-TRIMOXAZOLE480MGMEDICO REMEDIES PVT LTD,.-8 & 9 DEWAN AND SONS, UDYOG NAGAR, PALGHAR, DIST. THANE-401404, MAHARSHITRA DAWA LIMITED -16633-00620, RUARAKA, BABA DOGO ROAD, NAIROBI KENYAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
243NDA/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 BLISTER1/7/2015
244NDA/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 BLISTER1/7/2015
245NDA/MAL/HDP/0610ABACUS PARENTERAL DRUGS LIMITEDABACUS 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)1/7/2014
246NDA/MAL/HDP/0611GALPHAR LABORATORIES LTDAIVEEN (U) LIMITEDGALCIPRO 500CIPROFLOXACIN HYDROCHLORIDE500MGGALPHA LABORATORIES LIMITED-VILLAGE – THANA BADDI, TEHSIL BADDI
SOLAN HIMACHAL PRADESH-173 205 INDIA
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER1/7/2015
247NDA/MAL/HDP/0614GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDCLAVULINAMOXICILLIN + CLAVULANIC ACID125MG/5ML + 31.25MG/5MLSMITHKLINE BEECHAM PHARMACEUTICALS,-CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QH UNITED KINGDOMORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X70.0 ML BOTTLE,1.0X100.0 ML BOTTLE1/7/1998
248NDA/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 TUBE1/7/2014
249NDA/MAL/HDP/0619ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDD10GLUCOSE10%W/VABACUS PARENTERAL DRUGS LTD-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE,
MUKONO
UGANDAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X500.0 ML BOTTLE,1.0X250.0 ML BOTTLE1/7/2013
250NDA/MAL/HDP/0622PHARMACIE BETHELABACUS PARENTERAL DRUGS LIMITEDTENOL-50ATENOLOL50MGLINCOLN 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 BLISTER1/7/2014
251NDA/MAL/HDP/0623ABACUS PARENTERAL DRUGS LIMITEDABACUS 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 PACK1/7/2015
252NDA/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 BLISTER1/7/2015
253NDA/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 BLISTER1/7/2015
254NDA/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 BLISTER1/7/2011
255NDA/MAL/HDP/0633ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDCIPROCINCIPROFLOXACIN0.3%W/VABACUS PARENTERAL DRUGS LTD-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE,
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256NDA/MAL/HDP/0635GITTOES PHARMACEUTICALS 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 BLISTER1/7/2009
257NDA/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 TUBE1/7/2014
258NDA/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,
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259NDA/MAL/HDP/0639NEM LABORATORIES (PVT) LTDRENE PHARMACY LTDRHEUMATIC CREAMMULTI-INGREDIENTMULTI-INGREDIENTNEM LABORATORIES PVT LTD-PLOT NO. 133 KRISHNA IND. ESTATE, VASAI E,DIST PALGHAR- 401210, MAHARASHTRA STATE INDIATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE1/7/1997
260NDA/MAL/HDP/0643NAARI LTDPHARMA VILLE LIMITEDMISOPROMISOPROSTOL200MCGNAARI PHARMA PRIVATE LIMITED-PLOT NO. 14-16, 55-57, SECTOR-5, IIE, PANT NAGAR RUDRAPUR-263153 DIST-U.S. NAGAR UTTARAKHAND INDIAORAL SOLID ORDINARY TABLETS1.0X4.0 TABLET BLISTER,1.0X3.0 TABLET BLISTER,25.0X1.0X4.0 TABLET BLISTER1/7/2013
261NDA/MAL/HDP/0654NVS KENYA LTDSURGIPHARM (U) LIMITEDGALVUS METVILDAGLIPTIN / METFORMIN50MG/500MGNORVATIS PHARMA PRODUCTIONS GMBH, WEHR-GERMANY GERMANYORAL SOLID ORDINARY TABLETS1.0X60.0 TABLET CONTAINER1/7/2013
262NDA/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 BLISTER1/7/2013
263NDA/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 BLISTER1/7/2013
264NDA/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 BLISTER1/7/2013
265NDA/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 BLISTER1/7/2013
266NDA/MAL/HDP/0667ABACUS PHARMA (A) LTD.ABACUS 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 TUBE1/7/2013
267NDA/MAL/HDP/0668CADILA PHARMACEUTICALS LIMITEDPLANET PHARMACEUTICALS UGANDA LTDTELI 40TELMISARTAN40MGCADILA PHARMACEUTICALS LIMITED-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER1/7/2013
268NDA/MAL/HDP/0669ABACUS PHARMA (A) LTD.ABACUS 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 TUBE1/7/2013
269NDA/MAL/HDP/0670GITTOES PHARMACEUTICALS LIMITEDGITTOES 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 BLISTER1/7/2014
270NDA/MAL/HDP/0672GITTOES PHARMACEUTICALS 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 BLISTER1/7/2013
271NDA/MAL/HDP/0674GITTOES PHARMACEUTICALS LIMITEDGITTOES 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 BLISTER1/7/2013
272NDA/MAL/HDP/0675ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDAXCEL METRONIDAZOLE 400METRONIDAZOLE400MGKOTRA PHARMA-BHD
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273NDA/MAL/HDP/0677GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDDOPAMETMETHYLDOPA250MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER1/7/2014
274NDA/MAL/HDP/0678ABACUS PHARMA (A) LTD.ABACUS 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 TUBE1/7/2014
275NDA/MAL/HDP/0679GITTOES PHARMACEUTICALS LIMITEDGITTOES 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 BLISTER1/7/2013
276NDA/MAL/HDP/0681EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDELAXIM 40TENECTEPLASE (RECOMBINANT TISSUE PLASMINOGEN ACTIVATOR)40MG/VIALGENNOVA BIOPHARMACEUTICALS LIMITED-BLOCK 1, PLOT NO. P-1 AND P-2, ITBT PARK, PHASE II, MIDC, HINJAWADI, PUNE - 411057 INDIAPARENTERAL ORDINARY DRY VIALS1.0X40.0 MG VIAL , 1*8 ML VIAL OF WFI1/7/2013
277NDA/MAL/HDP/0685FERRER INTERNACIONAL S.ALABOREX UGANDA LIMITEDSOMAZINACITICOLINE1000MGFERRER INTERNATIONAL, S.A.-C/JOAN BUSCALLA, 1-9.08173 SANT CUGAT DEL VALLES, BARCELONA SPAINPARENTERAL RETARD I M AMPOULES1.0X5.0X4.0 ML AMPOULE1/7/2015
278NDA/MAL/HDP/0687FERRER INTERNACIONAL S.ALABOREX UGANDA LIMITEDSOMAZINACITICOLINE1000MGFERRER INTERNATIONAL, S.A.-C/JOAN BUSCALLA, 1-9.08173 SANT CUGAT DEL VALLES, BARCELONA SPAINORAL LIQUID ORDINARY LIQUIDS1.0X6.0X10.0 ML SACHET1/7/2015
279NDA/MAL/HDP/0688GITTOES PHARMACEUTICALS LIMITEDGITTOES 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 BLISTER1/7/2014
280NDA/MAL/HDP/0689GITTOES PHARMACEUTICALS LIMITEDGITTOES 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 BLISTER1/7/2013
281NDA/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 TUBE1/7/2014
282NDA/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 BLISTER1/7/2013
283NDA/MAL/HDP/0692DAWA LIMITEDSUPER MEDIC LTDDAWACLOX -250CLOXACILLIN SODIUM250MGDAWA LIMITED -BABA DOGO RWARAKAKENYAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER1/7/2015
284NDA/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 CONTAINER1/7/2014
285NDA/MAL/HDP/0694GITTOES PHARMACEUTICALS LIMITEDGITTOES 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 CARTON1/7/2013
286NDA/MAL/HDP/0696BYANSI SERVICES LIMITEDAIVEEN (U) LIMITEDRITONAVIRRITONAVIR100MGHETERO LABS LTD-22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESHINDIAORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET CONTAINER1/7/2014
287NDA/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 TUBE1/7/2003
288NDA/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)1/7/2015
289NDA/MAL/HDP/0702ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDSEPTOCINSTREPTOMYCIN SULPHATE1GMREYOUNG PHARMACEUTICAL CO. LIMITED-NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA CHINAPARENTERAL ORDINARY DRY VIALS1.0X50.0X1.0 G VIAL,1.0X100.0X1.0 G VIAL,1.0X10.0X1.0 G VIAL1/7/2014
290NDA/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 TUBE1/7/2013
291NDA/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 BLISTER1/7/2013
292NDA/MAL/HDP/0705LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDACICLOVIRACICLOVIR5%W/WLINCOLN PHARMACEUTICAL LIMITED-TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIA INDIATOPICAL EXTERNAL CREAMS1.0X10.0 G TUBE1/7/2011
293NDA/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 BLISTER1/7/2013
294NDA/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 BLISTER1/7/2013
295NDA/MAL/HDP/0712GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDZENTELALBENDAZOLE100MG/5MLASPEN BAD OLDESLOE GMBH, INDUSTRIESTRASSE-INDUSTRIESTRASSE 32-36, 23843 BAD OLDESLOE FRANCEORAL LIQUID ORDINARY SUSPENSIONS1.0X20.0 ML BOTTLE1/7/1997
296NDA/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 BLISTER1/7/2015
297NDA/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 BLISTER1/7/2015
298NDA/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 BLISTER1/7/2014
299NDA/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 BLISTER1/7/2014
300NDA/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 SYRINGE1/7/2011
301NDA/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 BOTTLE1/7/2013
302NDA/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 AMPOULE1/7/2014
303NDA/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 BOTTLE1/7/2014
304NDA/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 STRIP1/7/2014
305NDA/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 BOTTLE1/7/2013
306NDA/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 BLISTER1/7/2013
307NDA/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 BLISTER1/7/2013
308NDA/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 BLISTER1/7/2013
309NDA/MAL/HDP/0734AIVEEN (U) LIMITEDAIVEEN (U) LIMITEDOMMED -20OMEPRAZOLE20MGMEDICO REMEDIES PVT LIMITED-8 & 9 DEWAN & SONS, UDYOG NAGAR PALGAR, DISTRICT THANE MAHARASHTRA, INDIA INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE STRIP1/7/2015
310NDA/MAL/HDP/0736MEDOCHEMIE LTDLABOREX UGANDA LIMITEDMABRON 50TRAMADOL HYDROCHLORIDE50MGMEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY.-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA CYPRUSORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER1/7/2013
311NDA/MAL/HDP/0737SANOFI AVENTISSURGIPHARM (U) 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 VIAL1/7/2014
312NDA/MAL/HDP/0740MEDOCHEMIE LTDLABOREX UGANDA 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 BLISTER1/7/2013
313NDA/MAL/HDP/0741MEDOCHEMIE LTDLABOREX UGANDA 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 BLISTER1/7/2013
314NDA/MAL/HDP/0742MEDOCHEMIE LTDLABOREX UGANDA LIMITEDBROTMETFORMIN HYDROCHLORIDE500MGMEDOCHEMIE (FACTORY AZ).-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA, 4101 AGIOS ATHANASSIOS, LIMASSOL CYPRUSORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER1/7/2013
315NDA/MAL/HDP/0745CADILA PHARMACEUTICALS LIMITEDPLANET PHARMACEUTICALS UGANDA LTDTELI 80TELMISARTAN80MGB. BRAUN MELSUNGEN - MISTELWEG-1389, TRABAD ROAD, DHOLKA 387 810, DISTRICT AHMEDABAD, GUJARAT, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER1/7/2013
316NDA/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 BLISTER1/7/2013
317NDA/MAL/HDP/0748BAYER PHARMASURGIPHARM (U) LIMITEDXARELTO 15MGRIVAROXABAN15MGBAYER PHARMA AG 51368 LEVERKUSEN-BAYER PHARMA AG 51368 LEVERKUSENGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X14.0 TABLET BLISTER1/7/2013
318NDA/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 VIAL1/7/2014
319NDA/MAL/HDP/0750BAYER PHARMASURGIPHARM (U) LIMITEDXARELTO 20MGRIVAROXABAN20MGBAYER PHARMA AG 51368 LEVERKUSEN-BAYER PHARMA AG 51368 LEVERKUSENGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X14.0 TABLET BLISTER1/7/2013
320NDA/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 VIAL1/7/2014
321NDA/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 BLISTER1/7/2015
322NDA/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 BLISTER1/7/2014
323NDA/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 BLISTER1/7/2014
324NDA/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 BLISTER1/7/2011
325NDA/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 STRIP1/7/2011
326NDA/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 BOTTLE1/7/1999
327NDA/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 BLISTER1/7/2014
328NDA/MAL/HDP/0774CADILA PHARMACEUTICALS LIMITEDPLANET PHARMACEUTICALS UGANDA LTDNODONNEBIVOLOL10MGCADILA HEALTH CARE LIMITED -PLOT 203-213, KUNDAIM INDUSTRIAL ESTATE, GOA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X1.0X10.0 TABLET BLISTER1/7/2012
329NDA/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 BLISTER1/7/2014
330NDA/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 CONTAINER1/7/1999
331NDA/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 BLISTER1/7/2001
332NDA/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 BLISTER1/7/2013
333NDA/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 BLISTER1/7/2013
334NDA/MAL/HDP/0786TRIVENI FORMULATIONS LIMITEDAIVEEN (U) LIMITEDDERMA 1GRISEOFULVIN500MGTRIVENI FORMULATIONS LTD .-PLOT NO. 52, 53,54 ALEAP INDUSTRIAL ESTATE SURAMPALLI VILLAGE GANNAVARAM MANDAL KRISHNA (DT) A.P INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER1/7/2013
335NDA/MAL/HDP/0794REMINGTON PHARMACEUTICAL INDUSTRIES PVT LTDHEALTHCARE LTD.AMYGYDEXTOBRAMYCIN/DEXAMETHASONE3MG+1MG/MLREMINGTON PHARMACEUTICALS (PVT) LTD-18KM, MULTAN ROAD, LAHORE 53800, PAKISTAN PAKISTANOPHTHALMIC DROPS1.0X5.0 ML BOTTLE1/7/2014
336NDA/MAL/HDP/0796HETERO LABS LTDAIVEEN (U) LIMITEDAMLOSIN 5AMLODIPINE BESILATE5MGHETERO LABS LTD. UNIT (V) .-S.N0.439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE), JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA. HETERO LABS LIMITED, UNIT III - GENERAL- VILLAGE KALYANPUR, CHAKKAN ROAD, BADDI, DIST. SOLAN, HIMACHAL PRADESH, PIN CODE: 173205 - INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER1/7/2013
337NDA/MAL/HDP/0798HETERO LABS LTDAIVEEN (U) LIMITEDAMLOSIN 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 BLISTER,1.0X3.0X10.0 TABLET BLISTER1/7/2013
338NDA/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 BLISTER1/7/2015
339NDA/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 BOTTLE1/7/2005
340NDA/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 BLISTER1/7/2013
341NDA/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 BLISTER1/7/2012
342NDA/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 BLISTER1/7/2012
343NDA/MAL/HDP/0822ABACUS PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDCLOXCIN-500CLOXACILLIN SODIUM500MGREYOUNG PHARMACEUTICAL CO. LIMITED-NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA CHINAPARENTERAL ORDINARY DRY VIALS1.0X50.0X0.5 G VIAL,1.0X100.0X0.5 G VIAL,1.0X10.0X0.5 G VIAL1/7/2014
344NDA/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 BLISTER1/7/2013
345NDA/MAL/HDP/0824I CARE PHARMA LIMITEDVITACARE LTDCLOXACILLINCLOXACILLIN250MGMEDICO REMEDIES PVT LTD,.-8 & 9 DEWAN AND SONS, UDYOG NAGAR, PALGHAR, DIST. THANE-401404, MAHARSHITRA INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER1/7/2013
346NDA/MAL/HDP/0826I CARE PHARMA LIMITEDVITACARE LTDAMOXYCILLINAMOXYCILLIN250MGMEDICO REMEDIES PVT LTD,.-8 & 9 DEWAN AND SONS, UDYOG NAGAR, PALGHAR, DIST. THANE-401404, MAHARSHITRA INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER1/7/2013
347NDA/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 BLISTER1/7/2015
348NDA/MAL/HDP/0831I CARE PHARMA LIMITEDVITACARE LTDAMPICILLIN CAPSULESAMPICILLIN250MG MEDICO REMEDIES PVT LTD,.-8 & 9 DEWAN AND SONS, UDYOG NAGAR, PALGHAR, DIST. THANE-401404, MAHARSHITRA INDIAORAL SOLID ORDINARY OTHER CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER1/7/2013
349NDA/MAL/HDP/0832MERCKUNITED 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 BLISTER1/7/2015
350NDA/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 BLISTER1/7/2013
351NDA/MAL/HDP/0835GITTOES PHARMACEUTICALS LIMITEDGITTOES 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 CONTAINER1/7/2013
352NDA/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 BLISTER1/7/2012
353NDA/MAL/HDP/0841MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDETHOMIDETHIONAMIDE250MGMACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET STRIP1/7/2013
354NDA/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 BLISTER1/7/2013
355NDA/MAL/HDP/0843MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDCOXERINCYCLOSERINE250MGMACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIAINDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE STRIP1/7/2013
356NDA/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 BLISTER,1.0X5.0X1.0X10.0 TABLET BLISTER1/7/2013
357NDA/MAL/HDP/0846MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDMOXIMACMOXIFLOXACIN400MGMACLEODS PHARMACEUTICALS LTD--PLOT 25-27 SURVEY NO. 366 PREMIER INDUSTRIAL ESTATE KACHIGAM DAMANINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X5.0 TABLET BLISTER1/7/2014
358NDA/MAL/HDP/0848MACLEODS PHARMACEUTICALS LTDVITACARE 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 CONTAINER1/7/2014
359NDA/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)1/7/2012
360NDA/MAL/HDP/0853SUN PHARMACEUTICAL INDUSTRIES LIMITED -STAR PHARMACEUTICALS LTDBRUSTAN GELIBUPROFEN + LEVOMENTHOL5% W/W+ 3%W/WRANBAXY LABORATORIES LTD GOA-NO.2 MADKAI INDUSTRIAL ESTATE GOA 403 404INDIATOPICAL EXTERNAL LOTIONS1.0X50.0 G CONTAINER1/7/2012
361NDA/MAL/HDP/0855HETERO LABS LTDAIVEEN (U) LIMITEDLAZINELEVOCETIRIZINE DIHYDROCHLORIDE5MGHETERO LABS LTD-22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESHINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER1/7/2013
362NDA/MAL/HDP/0857GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDCANDID-V6 VAGINAL TABLETSCLOTRIMAZOLE100MGGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D INDIAVAGINAL TABLETS1.0X6.0 PESSARY STRIP1/7/2000
363NDA/MAL/HDP/0858ASTRA ZENECAMACNAUGHTON LIMITEDPLENDILFELODIPINE5MGASTRAZENECA SWEDEN OPERATIONS-ASTRAZENECA SWEDEN OPERATIONS SE-151 85 SODERTALJESWEDENORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET CONTAINER1/7/2001
364NDA/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 BLISTER,1.0X3.0X10.0 TABLET BLISTER1/7/2013
365NDA/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 BOTTLE1/7/2013
366NDA/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 VIALS1.0X2.0X6.0X2.0 ML VIAL1/7/2013
367NDA/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 AMPOULE1/7/2013
368NDA/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 AMPOULE1/7/2010
369NDA/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 VIAL1/7/2013
370NDA/MAL/HDP/0873GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDOXYTOCIN INJECTIONOXYTOCIN10I.U/MLSAKAR HEALTH CARE PVT LTD-10/13 CHONGODAR SARKHEJ BAVLA ROAD DIST AHEMABAD 382213 GUJARATI NINGBO DAHONGYING PHARMACEUTICAL CO LTD-NO 396, MINGZHU ROAD NINGBO CITY CHINA CHINAPARENTERAL ORDINARY AMPOULES1.0X10.0X1.0 ML AMPOULE1/7/2009
371NDA/MAL/HDP/0874LEBEN LABORATORIES PVT LTDMALIX PHARMA (U) LIMITEDLEBASMA-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 BLISTER1/7/2014
372NDA/MAL/HDP/0877LEBEN LABORATORIES LTDMALIX PHARMA (U) LIMITEDANTAGIT 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 BOTTLE1/7/2007
373NDA/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 BLISTER1/7/2012
374NDA/MAL/HDP/0882MERCKUNITED 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 BLISTER1/7/2012
375NDA/MAL/HDP/0883MERCKUNITED 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 BLISTER1/7/2012
376NDA/MAL/HDP/0889ABACUS PARENTERAL DRUGS LIMITEDABACUS 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 BOTTLE1/7/2012
377NDA/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 BLISTER,1.0X4.0 TABLET BLISTER1/7/2014
378NDA/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 SYRINGE1/7/2015
379NDA/MAL/HDP/0897VIRCHOW HEALTHCARE PVT LTDLEGIT MEDEQ 2007 LIMITEDDEBRIDACEPAPAIN + UREA521700UNITS+100MG/GVIRCHOW BIOTECH PVT, -SURVEY NO. 172, PART GAGILLAPUR, QUTHBULLAPUR, R.R, DISTRICT TELANGANA INDIATOPICAL EXTERNAL OINTMENTS1.0X15.0 G TUBE1/7/2015
380NDA/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 WFI1/7/2013
381NDA/MAL/HDP/0902GITTOES PHARMACEUTICALS LIMITEDGITTOES 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 BLISTER1/7/2013
382NDA/MAL/HDP/0906VIRCHOW HEALTHCARE PVT LTDLEGIT MEDEQ 2007 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 TUBE1/7/2015
383NDA/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 TUBE1/7/2015
384NDA/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 VIALS1.0X3.0 ML VIAL,1.0X3.0 ML PREFILLED PEN1/7/2015
385NDA/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 STRIP1/7/2014
386NDA/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 VIAL1/7/2012
387NDA/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 STRIP1/7/2004
388NDA/MAL/HDP/0928AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDINSTACLOP 75CLOPIDOGREL75MGAJANTA PHARMA LIMITED-AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. AJANTA PHARMA LIMITED-PLOT NO.Z/103/A,DAHEJ SEZ PART 11,DISTRICT: BHARUCH,GUJARAT-392130 INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET STRIP1/7/2013
389NDA/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 BLISTER1/7/2012
390NDA/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 BLISTER1/7/2011
391NDA/MAL/HDP/0938FEROZSONS LABORATORIES LTDHARLEYS UGANDA LIMITEDESOMEGA 20MGESOMEPRAZOLE AS MAGNESSIUM TRIHYDRATE PELLETS20MGFEROZSONS LABORATORIES LTD-AMANGARH-NOWSHERA, (KHYBER
PAKHTOONKHWA), PAKISTAN
INDIAORAL SOLID ORDINARY CAPSULES1.0X2.0X7.0 CAPSULE BLISTER1/7/2013
392NDA/MAL/HDP/0939LINCOLN P'CALS LTDMETRO PHARMACEUTICALS LIMITEDARHALPHA -BETA ARTEETHER150MG /2MLLINCOLN PARENTERAL LTD .-11, TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. BOX KHATRAJ 382721 TA: KALOL DIST. GANDHINAGAR GUJARAT INDIAPARENTERAL ORDINARY AMPOULES1.0X3.0X2.0 ML AMPOULE1/7/2012
393NDA/MAL/HDP/0940FEROZSONS LABORATORIES LTDHARLEYS UGANDA LIMITEDESOMEGA 40MGESOMEPRAZOLE AS MAGNESSIUM TRIHYDRATE PELLETS40MGFEROZSONS LABORATORIES LTD-AMANGARH-NOWSHERA, (KHYBER
PAKHTOONKHWA), PAKISTAN
INDIAORAL SOLID ORDINARY CAPSULES1.0X2.0X7.0 CAPSULE BLISTER1/7/2013
394NDA/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 BOTTLE1/7/2013
395NDA/MAL/HDP/0942LINCOLN PARENTERAL LIMITEDMETRO PHARMACEUTICALS LIMITEDARH FORTEALPHA -BETA ARTEETHER225MG/ 3MLLINCOLN PARENTERAL LTD .-11, TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. BOX KHATRAJ 382721 TA: KALOL DIST. GANDHINAGAR GUJARAT INDIAPARENTERAL ORDINARY AMPOULES1.0X3.0X3.0 ML AMPOULE1/7/2012
396NDA/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 BOTTLE1/7/2013
397NDA/MAL/HDP/0952NEON LABARATORIES LTD.NORVIK ENTERPRISES LIMITEDEFECTALCEFTRIAXONE1GNEON LABORATORIES LTD-PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROAD INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0 G VIAL1/7/2013
398NDA/MAL/HDP/0953NEON LABARATORIES LTD.NORVIK ENTERPRISES LIMITEDCIZCANCISPLATIN10MG/10MLNEON LABORATORIES LTD-PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROAD INDIAPARENTERAL ORDINARY VIALS1.0X10.0 ML VIAL1/7/2013
399NDA/MAL/HDP/0954NEON LABARATORIES LTD.NORVIK ENTERPRISES LIMITEDANAWINBUPIVACAINE50MG/20MLNEON LABORATORIES LTD-PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROAD INDIAPARENTERAL RETARD OTHER VIALS1.0X20.0 ML VIAL1/7/2013
400NDA/MAL/HDP/0957MACK BROWN PHARMACEUTICALS PVT LIMITEDSHURIK LTDLYRED SYRUPVITAMINE A + VITAMINE E ACETATE + ASCORBIC ACID + SELENIUM + ZINC2500 IU + 10 IU + 50MG + 35MCG + 3MGTORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506INDIAORAL LIQUID ORDINARY SYRUPS1.0X200.0 ML BOTTLE1/7/2012
401NDA/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 BLISTER1/7/2013
402NDA/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 BLISTER1/7/2013
403NDA/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 BLISTER1/7/2013
404NDA/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 BLISTER1/7/2005
405NDA/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 BLISTER1/7/2013
406NDA/MAL/HDP/0988CADILA PHARMACEUTICALS LIMITEDPLANET PHARMACEUTICALS UGANDA LTDCADITOR 20ATORVASTATIN20MGCADILA PHARMACEUTICALS LIMITED-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER1/7/2013
407NDA/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 TUBE1/7/2013
408NDA/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 BOTTLE1/7/2014
409NDA/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 BLISTER1/7/2013
410NDA/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 BLISTER1/7/2014
411NDA/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 AMPOULE1/7/2012
412NDA/MAL/HDP/1001EVA PHARMAWIDE SPECTRUM ENTERPRISES (U) LIMITEDTHIOEVATHIOTIC ACID300MGEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT EGYPTORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER1/7/2013
413NDA/MAL/HDP/10018RATNAMANI HEALTHCARE PVT. LTDVIDA AFRICA LTDBRUMAX PLUS TABLETSIBUPROFEN + PARACETAMOL400MG + 325MGRATNAMANI HEALTHCARE PRIVATE LIMITED-SURVEY NO. 750/1, AHMEDABAD - MEHSANA HIGHWAY, VILLAGE-INDRAD, NR. CHHATRAL G.I.D.C., TALUKA-KADI, DIST-MEHSANA, PIN-382721 (NG), GUJARAT - INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X10.0 TABLET BLISTER28/2/2022
414NDA/MAL/HDP/10030SAKAR HEALTHCARE LIMITED -TATA UGANDA LIMITEDNISTANNYSTATIN100,000IUSAKAR HEALTHCARE PVT LTD-BLOCK NO. 10-13, NR. M.N DESAI PETRO PUMP, SARKHEJ-BAVLA ROAD, CHANGODAR, DIST: AHMEDABAD-382213, GUJARAT INDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X30.0 ML BOTTLE17/5/2022
415NDA/MAL/HDP/1005AXA PARENTERALS LTDVITACARE LIMITEDAXA-ORNIORNIDAZOLE5MG/MLAXA PARENTERALS LTD-KISHNPUR, JAMALPUR ROORKEE- 247677 INDIAPARENTERAL ORDINARY VIALS1.0X100.0 ML BOTTLE1/7/2015
416NDA/MAL/HDP/1006MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDTRIPRIDE-2GLIMEPIRIDE + PIOGLITAZONE+ METFORMIN2MG+15MG+500MGMICRO LABS LTD 92 SIPCOT -92 SIPCOT HOSUR 635 126 TAMIL NADUINDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER1/7/2012
417NDA/MAL/HDP/1007COSMOS LTDASTRA PHARMA (U) LIMITEDZINCOS DISPERSIBLE TABLETS 20MGZINC SULPHATE20MGCOSMOS LIMITED, KENYA-RANGWE ROAD, OFF LUNGA ROAD, INDUSTRIAL AREA
NAIROBI - KENYA
KENYAORAL SOLID ORDINARY SOLUBLE TABLETS1.0X10.0X10.0 TABLET BLISTER1/7/2013
418NDA/MAL/HDP/1009TROIKAA PHARMACEUTICALS LIMITEDABACUS PHARMA (AFRICA) LIMITEDBUPITROY 0.5%BUPIVACAINE5MG/ML TROIKAA PHARMACEUTICALS LTD .-SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHAND, INDIA INDIAPARENTERAL ORDINARY VIALS1.0X20.0 ML VIAL1/7/2012
419NDA/MAL/HDP/1011COSMOS LTDASTRA PHARMA (U) LIMITEDDABORAL SYRUPAMINOSIDINE125MG/5MLCOSMOS LIMITED, KENYA-RANGWE ROAD, OFF LUNGA ROAD, INDUSTRIAL AREA
NAIROBI - KENYA
KENYAORAL LIQUID ORDINARY SYRUPS1.0X60.0 ML BOTTLE1/7/2012
420NDA/MAL/HDP/1012NEON LABARATORIES LTD.NORVIK ENTERPRISES LIMITEDLOX 2%LIDOCAINE2% W/VNEON LABORATORIES LTD-PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROAD INDIAPARENTERAL ORDINARY OTHER VIALS1.0X50.0 ML VIAL,1.0X20.0 ML VIAL1/7/2013
421NDA/MAL/HDP/1013NEON LABARATORIES LTD.NORVIK ENTERPRISES LIMITEDTHIOSOLTHIOPENTAL SODIUM500MGNEON LABORATORIES LTD-PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROAD INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0X20.0 ML VIAL1/7/2013
422NDA/MAL/HDP/1017ELYS CHEMICAL INDUSTRIES LTDVELVET PHARMA LIMITEDELYCLOXAMPICILLIN/CLOXACILLIN125MG/125MGELYS CHEMICAL INDUSTRIES LIMITED-ROAD B’, OFF ENTERPRISE ROAD
PLOT NO. 209/8927 INDUSTRIAL AREA
KENYAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE1/7/2015
423NDA/MAL/HDP/1018KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAM CHLORCHLORAMPHENICOL250MGKAMPALA PHARMECEUTICALS INDUSTRIES LTD.-PLOT M444B STRETCHER RD, NTINDA KLA UGANDA UGANDAORAL SOLID ORDINARY CAPSULES100.0 CAPSULE CONTAINER,1000.0 CAPSULE CONTAINER,250.0 CAPSULE CONTAINER,500.0 CAPSULE CONTAINER,1.0X10.0 CAPSULE CONTAINER1/7/1997
424NDA/MAL/HDP/1020LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDPA-12PARACETAMOL SUSTAINED RELEASE1000MGLINCOLN PHARMACEUTICALS LIMITED-10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
INDIAORAL SOLID RETARD LAYERED TABLETS1.0X10.0X1.0X12.0 TABLET BLISTER1/7/2012
425NDA/MAL/HDP/1022EVA PHARMA FOR PHARMACEUTICALS & MEDICAL APPLIANCES -WIDE SPECTRUM ENTERPRISES (U) LIMITEDCONVENTINGABAPENTIN300MGEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT EGYPTORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER1/7/2013
426NDA/MAL/HDP/1030LABORATORIOS SALVAT SALABOREX UGANDA LIMITEDMALACURDIHYDROARTEMISININ + PIPERAQUINE PHOSPHATE40MG + 320MGCIRON DRUGS PHARMACEUTICALS PRIVATE LTD,-35-37, 43-45, CFC-B DEWAN UDYOG NAGAR, ALIYALI, DIST - PALGHAR 401 404, MAHARASHTRA INDIAORAL SOLID ORDINARY TABLETS1.0X1.0X12.0 TABLET BLISTER1/7/2014
427NDA/MAL/HDP/1031EVA PHARMAWIDE SPECTRUM ENTERPRISES (U) LIMITEDMOXIFLOXMOXIFLOXACIN400MGEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT EGYPTORAL SOLID ORDINARY TABLETS1.0X1.0X5.0 TABLET BLISTER1/7/2013
428NDA/MAL/HDP/1032EVA PHARMAWIDE SPECTRUM ENTERPRISES (U) LIMITEDARTHFREE 20LEFLUNOMIDE20MGEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT EGYPTORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER1/7/2013
429NDA/MAL/HDP/1033FAES FARMA S.APHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDDYNAMOGENGLUTODINE (CYPROHEPTADINE ALPHA- KETOGLUTARATE) + ARGININE ASPARTATE3MG +1GFAES FARMA, S.A -MAXIMO AGUIRRE, 14, LEJONA 48940 VIZCAYA SPAINORAL LIQUID ORDINARY LIQUIDS1.0X20.0X10.0 ML SACHET1/7/2015
430NDA/MAL/HDP/1035B&O PHARMTRIDEM PHARMA UGANDA LIMITEDG-CIPROXCIPROFLOXACIN500MGGUILIN PHARMACEUTICAL CO.LTD.-NO.43 QUILIDIAN ROAD GUILIN 541002, GUANGXI, CHINA CHINAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER1/7/2014
431NDA/MAL/HDP/1042ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDARISTO TELVAS-H 80/12.5TELMISARTAN +HYDROCHLOROTHIAZIDE80MG +12.5 MGARISTO 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 STRIP,1.0X3.0X10.0 TABLET STRIP1/7/2013
432NDA/MAL/HDP/1044UNITED PHARMACEUTICAL MANUFACTURING CO. LTDWIDE SPECTRUM ENTERPRISES (U) LIMITEDANGINET 80MGVALSARTAN80MGUNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD-P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSINGJORDANORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER1/7/2013
433NDA/MAL/HDP/1047UNITED PHARMACEUTICAL MANUFACTURING CO. LTDWIDE SPECTRUM ENTERPRISES (U) LIMITEDEXOFEN 180MGFEXOFENADINE180MGUNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD-P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSINGJORDANORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X15.0 TABLET BLISTER1/7/2013
434NDA/MAL/HDP/1048UNITED PHARMACEUTICAL MANUFACTURING COMPANY LIMITEDWIDE SPECTRUM ENTERPRISES (U) LIMITEDEXOFEN 120MGFEXOFENADINE120MGUNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD-P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSINGJORDANORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X15.0 TABLET BLISTER1/7/2013
435NDA/MAL/HDP/1049GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOVATEBETAMETHASONE VALERATE0.1%W/WAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIATOPICAL EXTERNAL OINTMENTS1.0X15.0 G TUBE1/7/2013
436NDA/MAL/HDP/1050INTAS PHARMACEUTICALS LIMITEDNORVIK ENTERPRISES LIMITEDAMTAS-10AMLODIPINE10MGINTAS PHARMACEUTICALS LTD-PLOT 457/458, SARKHEJ BAVLA HIGHWAY
MATODA 382 210 TAL: SANAND, AHMEDABAD, INDIA
INTAS PHARMACEUTICALS LIMITED -CAMP ROAD, SELAQUI-248197, DEHRADUN (UTTARAKHAND)
INDIAORAL SOLID ORDINARY TABLETS1.0X2.0X14.0 TABLET BLISTER,10.0X10.0 TABLET BLISTER1/7/2013
437NDA/MAL/HDP/1052GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDMICLOGENMICONAZOLE NITRATE+CLOBETASOLE PROPIONATE+GENTAMICIN SULPHATE2.0%W/W+0.05%W/W+0.1W/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 TUBE1/7/2013
438NDA/MAL/HDP/1056GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOVATE-N OINTMENTBETAMETHASONE + NEOMYCIN0.1%W/W + 0.5% W/WAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIATOPICAL EXTERNAL OINTMENTS1.0X1.0X15.0 G TUBE1/7/2013
439NDA/MAL/HDP/1061SHOSAAN ASIC PACIFICRENE PHARMACY LTDBISACODYL TABLETSBISACODYL5MGNEM LABORATORIES PVT LTD-PLOT NO. 133 KRISHNA IND. ESTATE, VASAI E,DIST PALGHAR- 401210, MAHARASHTRA STATE INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER1/7/2010
440NDA/MAL/HDP/1062VENUS REMEDIES LTDHARLEYS UGANDA LIMITEDVANCONEX-CPVANCOMYCIN500MGVENUS REMEDIES LIMITED-UNIT II HILL TOP INDUSTRIAL ESTATE JHARMAJRI EPIP
PHASE I BHATOLI BADDI (HP) 173205
INDIA
INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0 VIAL CARTON1/7/2013
441NDA/MAL/HDP/1065BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDSLIPIZEM-5DIAZEPAM5MGBLISS 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 BLISTER1/7/2007
442NDA/MAL/HDP/1067MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDIBUPARAIBUPROFEN+PARACETAMOL200MG+ 250MG/10MLTORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506INDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE1/7/2010
443NDA/MAL/HDP/1069CIRON DRUGS & PHARMACEUTICALS PVT LTDRENE PHARMACY LTDK-ONE INJECTIONPHYTOMENADIONE10MG/MLCIRON DRUGS & PHARMACEUTICALS PVT LTD-N-118, N-119 MIDC TARAPUR BOISAR DIST THANE 401506 MAHARASHTRA INDIA INDIAPARENTERAL ORDINARY AMPOULES1.0X10.0X10.0X1.0 ML AMPOULE1/7/2014
444NDA/MAL/HDP/1071UNITED PHARMACEUTICAL MANUFACTURING CO. LTDWIDE SPECTRUM ENTERPRISES (U) LIMITEDCO-ANGINET 160/25MGVALSARTAN + HYDROCHLOROTHIAZIDE160 MG + 25 MGUNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD-P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSINGJORDANORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER1/7/2013
445NDA/MAL/HDP/1072UNITED PHARMACEUTICAL MANUFACTURING CO. LTDWIDE SPECTRUM ENTERPRISES (U) LIMITEDCO-ANGINET 80/12.5MGVALSARTAN + HYDROCHLOROTHIAZIDE80MG + 12.5MGUNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD .-57 UBAYBIN MUAATH STREET AL RAGEEM-SAHAB, AMMAN, JORDAN JORDANORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET STRIP1/7/2013
446NDA/MAL/HDP/1076UNITED PHARMACEUTICAL MANUFACTURING CO. LTDWIDE SPECTRUM ENTERPRISES (U) LIMITEDUNICAST 4MGMONTELUKAST SODIUM4MGUNITED 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 BLISTER1/7/2013
447NDA/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 BOTTLE1/7/2013
448NDA/MAL/HDP/1079GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOG-QUININE 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 BOTTLE1/7/2000
449NDA/MAL/HDP/1080ALKEM LABORATORIES LIMITEDABACUS PHARMA (AFRICA) LIMITEDZOCEF 250 TABLETSCEFUROXIME AXETIL250MGALKEM LABORATORIES LIMITED.-VILLAGE THANA, BADDI, TEHSIL-NALAGARH, DISTT-SOLAN, (HP), INDIA-173205 EAST AFRICAN (INDIA) OVERSEAS-PLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X6.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER1/7/2009
450NDA/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 BOTTLE1/7/2013
451NDA/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 BOTTLE1/7/2013
452NDA/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 BLISTER1/7/2013
453NDA/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 TUBE1/7/2013
454NDA/MAL/HDP/1086SHOSAAN ASIC PACIFICRENE 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 BLISTER1/7/2012
455NDA/MAL/HDP/1087GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOCYCLINETETRACYCLINE3%W/WAGOG PHARMA LTD.-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIATOPICAL EXTERNAL OINTMENTS1.0X15.0 G TUBE1/7/2013
456NDA/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 VIAL1/7/2015
457NDA/MAL/HDP/1093STRIDES SHASUN LIMITEDDELMAW ENTERPRISES LIMITEDEMTRICITABINE + TENOFOVIR DISOPROXIL FUMARATEEMTRICITABINE+TENOFOVIR DISOPROXIL FUMARATE200MG+300MGSTRIDES ARCOLAB LIMITED -36/7 SURAGAJAKKANAHALLI INDLAVADI CROSS ANEKAL TALUK BANGALORE 562 106INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X30.0 TABLET CONTAINER1/7/2013
458NDA/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 BOTTLE1/7/2013
459NDA/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 BLISTER1/7/2012
460NDA/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 TUBE1/7/2012
461NDA/MAL/HDP/1100GITTOES PHARMACEUTICALS LIMITEDGITTOES 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 TUBE1/7/2013
462NDA/MAL/HDP/1103GITTOES PHARMACEUTICALS LIMITEDGITTOES 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 TUBE1/7/2014
463NDA/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 BLISTER1/7/2013
464NDA/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)1/7/2005
465NDA/MAL/HDP/1109DAWA LIMITEDSUPER MEDIC LTDDAWA-CPMCHLORPHENIRAMINE MALEATE2MG/5MLDAWA PHARMACEUTICALS LIMITED-PLOT 7879, BABA DOGO ROAD RUARAKA KENYAORAL LIQUID ORDINARY SYRUPS1.0X60.0 ML BOTTLE1/7/2014
466NDA/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 TUBE1/7/2013
467NDA/MAL/HDP/1113MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDALCID-YELLOWMULTI-INGREDIENTMULTI-INGREDIENTTORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506INDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X400.0 ML BOTTLE,1.0X160.0 ML BOTTLE1/7/1997
468NDA/MAL/HDP/1114SHOSAAN ASIC PACIFICRENE 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 CONTAINER1/7/2012
469NDA/MAL/HDP/1117SHOSAAN ASIC PACIFICRENE 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 TUBE1/7/2013
470NDA/MAL/HDP/1125AUROBINDO PHARMA LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDAUROXONE 1000CEFTRIAXONE1000MGAUROBINDO PHARMA LIMITED, FORMULATIONS UNIT-VI- R7-AUROBINDO PHARMA LIMITED, FORMULATIONS UNIT-VI SY.NO.329/39 & 329/47 CHITKUL(V) PATANCHERU MANDAL, SANGA REDDY DISTTELANGANA502307 INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0 G VIAL1/7/2009
471NDA/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 BLISTER1/7/2013
472NDA/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 BLISTER1/7/2012
473NDA/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 STRIP1/7/2012
474NDA/MAL/HDP/1136GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOSCAB APPLICATIONBENZYL BENZOATE25%W/WAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIATOPICAL EXTERNAL EMULSIONS1.0X1.0X100.0 ML BOTTLE1/7/2013
475NDA/MAL/HDP/1138GITTOES PHARMACEUTICALS LIMITEDGITTOES 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 BOTTLE,1.0X60.0 ML BOTTLE1/7/2013
476NDA/MAL/HDP/1139GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOVATEBETAMETHASONE0.1%W/WAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE1/7/2012
477NDA/MAL/HDP/1140GITTOES PHARMACEUTICALS LIMITEDGITTOES 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 TUBE1/7/2013
478NDA/MAL/HDP/1141LINCOLN P'CALS LTDMETRO PHARMACEUTICALS LIMITEDCALBONECALCIUM CARBONATE + COLECALCIFEROL250MG+125MG/5MLLINCOLN PARENTERAL LTD .-11, TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. BOX KHATRAJ 382721 TA: KALOL DIST. GANDHINAGAR GUJARAT INDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE1/7/2012
479NDA/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 BLISTER1/7/2012
480NDA/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 BOTTLE1/7/2005
481NDA/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 BLISTER1/7/2012
482NDA/MAL/HDP/1149UNIVERSAL CORPORATION LTDDELMAW ENTERPRISES LIMITEDNEUROBAGABAPENTIN300MGUNIVERSAL CORPORATION LTD..-PLOT 13777 CLUB ROAD, PAST KIKUYU KENYAORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER1/7/2015
483NDA/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 VIAL1/7/2012
484NDA/MAL/HDP/1155TRIVENI FORMULATIONS LIMITEDSUPER MEDIC LTDDOXYCYCLINEDOXYCYCLINE100TRIVENI FORMULATION LTD-PLOT NO.52,53,54,63,62,64, ALEAP INDUSTRIAL ESTATE SURAMPALI,
AP-INDIA – 521212
INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER1/7/2012
485NDA/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 BLISTER1/7/2012
486NDA/MAL/HDP/1160DAFRA PHARMA LTDMULTIPHAR UGANDA LIMITEDDAFRACLAVAMOXYCILLIN + CLAVULANIC ACID875MG+125MGBILIM PHARMACEUTICALS--CERKEZKOY PLANT, 59500 CERKEZKOY, TEKIRDAG TURKEYORAL SOLID ORDINARY TABLETS1.0X2.0X5.0 TABLET BLISTER1/7/2011
487NDA/MAL/HDP/1163SHOSAAN ASIC PACIFICRENE PHARMACY LTDFRUSEMIDEFUROSEMIDE40MGNEM LABORATORIES PVT LTD-PLOT NO. 133 KRISHNA IND. ESTATE, VASAI E,DIST PALGHAR- 401210, MAHARASHTRA STATE INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER1/7/2013
488NDA/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 BLISTER1/7/2013
489NDA/MAL/HDP/1166PANACEA BIOTEC PHARMA LTDVITACARE LIMITEDDOLZEROTRAMADOL HYDROCHLORIDE + PARACETAMOL37.5MG + 325MGPANACEA BIOTEC PHARMA LIMITED-MALPURI BADDI, DISTRICT SOLAN, HIMACHAL PRADESH-173205 - INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER1/7/2013
490NDA/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 AMPOULE1/7/2010
491NDA/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 TUBE1/7/2009
492NDA/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 BLISTER,1.0X3.0X3.0X10.0 TABLET BLISTER1/7/2013
493NDA/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 AMPOULES1.0X1.0 ML AMPOULE1/7/2013
494NDA/MAL/HDP/1172CIRON DRUGS AND PHARMACEUTICALS PVT LTDRENE PHARMACY LTDLIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDE20MG/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 VIAL1/7/2010
495NDA/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 CONTAINER1/7/2013
496NDA/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 CARTON1/7/2015
497NDA/MAL/HDP/1182TORRENT PHARAMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.ASTHATOR 5MONTELUKAST SODIUM5MGTORRENT PHARMACEUTICALS LTD .,-AHMEDABAD-MEHSANA HIGHWAY, TALUKA-KADI, DIST. MEHSANA, INDRAD-382721, GUJARAT INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER1/7/2013
498NDA/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 BOTTLE1/7/2013
499NDA/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 BOTTLE1/7/2013
500NDA/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 BOTTLE1/7/2013
501NDA/MAL/HDP/1188ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDGMYCIN-80GENTAMYCIN SULPHATE80MG/2MLREYOUNG PHARMACEUTICAL CO. LIMITED-NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA CHINAPARENTERAL ORDINARY AMPOULES1.0X100.0X2.0 ML AMPOULE1/7/2013
502NDA/MAL/HDP/1189ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDDICLOMAX-75DICLOFENAC SODIUM75MG/MLREYOUNG PHARMACEUTICAL CO. LIMITED-NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA CHINAPARENTERAL ORDINARY AMPOULES1.0X10.0X10.0X3.0 ML AMPOULE1/7/2013
503NDA/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 VIAL1/7/2009
504NDA/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 BOTTLE1/7/2013
505NDA/MAL/HDP/1196UNIVERSAL CORPORATION LTDDELMAW ENTERPRISES LIMITEDACNESOLTRETINOIN0.05%W/WUNIVERSAL CORPORATION LTD..-PLOT 13777 CLUB ROAD, PAST KIKUYU KENYATOPICAL EXTERNAL CREAMS1.0X25.0 G TUBE1/7/2012
506NDA/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 CONTAINER1/7/2008
507NDA/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 CONTAINER1/7/2013
508NDA/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 BOTTLE,1.0X100.0 ML BOTTLE1/7/2011
509NDA/MAL/HDP/1211ASTRA ZENECAMACNAUGHTON LIMITEDBRILINTATICAGRELOR90MGASTRA ZENECA AB-SE-151 85 SODERTALJE, SWEDEN (GARTUNAVAGEN & SNACKVIKEN) UNITED KINGDOMORAL SOLID ORDINARY TABLETS1.0X4.0X14.0 TABLET BLISTER1/7/2011
510NDA/MAL/HDP/1212GUILIN PHARMACEUTICALS CO.LTDTRIDEM PHARMA UGANDA LIMITEDGLINTHERARTEMETHER80MG/MLGUILIN PHARMACEUTICAL CO.,LTD-NO 43 QILIDIAN ROAD GUILIN 541002, GUANGXI CHINAPARENTERAL ORDINARY I M AMPOULES1.0X6.0X1.0 ML AMPOULE1/7/2011
511NDA/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 BLISTER1/7/2013
512NDA/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 BLISTER1/7/2013
513NDA/MAL/HDP/1219DENK PHARMA GMBH & 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 BLISTER1/7/2014
514NDA/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 BLISTER1/7/2008
515NDA/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 TUBE1/7/1997
516NDA/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 BLISTER1/7/2005
517NDA/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 BLISTER1/7/2013
518NDA/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 BOTTLE1/7/2012
519NDA/MAL/HDP/1234MACLEODS PHARMACEUTICALS LTDVITACARE 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 STRIP1/7/2007
520NDA/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 BLISTER1/7/2014
521NDA/MAL/HDP/1244GLENMARK PHARMACUTICALS LTDSTAR PHARMACEUTICALS LTDFLEXILOR SRLORNOXICAM16MGGLENMARK PHARMACEUTICALS LTD .-VILLAGE KISHANPURA, BADDI-NALAGARH ROAD, TEHSIL BADDI, DISTRICT SOLAN HP 173205 INDIAORAL SOLID RETARD FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER1/7/2014
522NDA/MAL/HDP/1245GLENMARK PHARMACUTICALS LTDSTAR PHARMACEUTICALS LTDFLEXILOR P8LORNOXICAM + PARACETAMOL8MG + 500MGGLENMARK PHARMACEUTICALS LTD .-VILLAGE KISHANPURA, BADDI-NALAGARH ROAD, TEHSIL BADDI, DISTRICT SOLAN HP 173205 INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER1/7/2014
523NDA/MAL/HDP/1247GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDPROCIPCYPROHEPTADINE4MGAGOG PHARMA LTD.-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIAORAL SOLID ORDINARY TABLETS1.0X2.0X5.0X10.0 TABLET BLISTER1/7/2012
524NDA/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 BLISTER1/7/2014
525NDA/MAL/HDP/1252MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDZOYSILDENAFIL50MGTORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506INDIAORAL SOLID ORDINARY TABLETS1.0X1.0X4.0 TABLET BLISTER1/7/2013
526NDA/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 CONTAINER1/7/1998
527NDA/MAL/HDP/1255CIPLA LTD.CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDNIFELAT RETARDNIFEDIPINE20MGCIPLA LTD-MIDC PATALGANGA 410 220 DIST. RAIGADINDIAORAL SOLID RETARD TABLETS1.0X10.0X10.0 TABLET BLISTER1/7/1997
528NDA/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 TUBE1/7/2000
529NDA/MAL/HDP/1265GITTOES PHARMACEUTICALS LIMITEDGITTOES 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 BLISTER1/7/2008
530NDA/MAL/HDP/1271INCEPTA PHARMACUTICALS LIMITEDPHARMA VILLE LIMITEDONASERONONDANSETRON4MG/5MLINCEPTA PHARMACEUTICALS LIMITED- DEWAN IDRIS ROAD, BARA RANGAMATIA, ZIRABO
SAVAR, DHAKA, BANGLADESH
BANGLADESHORAL LIQUID ORDINARY LIQUIDS1.0X1.0X50.0 ML BOTTLE1/7/2012
531NDA/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 BLISTER1/7/1997
532NDA/MAL/HDP/1276INCEPTA PHARMACUTICALS LIMITEDPHARMA VILLE 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% NACL1/7/2013
533NDA/MAL/HDP/1278SHANGHAI FOSUN PHARMACEUTICAL DEVELOPMENT CO. LTDTRIDEM PHARMA UGANDA LIMITEDD-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 BLISTER,1.0X25.0X1.0X9.0 TABLET BLISTER1/7/2013
534NDA/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 BLISTER1/7/2016
535NDA/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 VIAL1/7/2012
536NDA/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 BOTTLE1/7/2014
537NDA/MAL/HDP/1288PHARCO PHARMACEUTICALSWIDE SPECTRUM ENTERPRISES (U) LIMITEDVITAMINAT SYRUPVITAMIN B COMPLEXMULT-INGREDIENTPHARCO 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 BOTTLE1/7/1998
538NDA/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 BLISTER1/7/2013
539NDA/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 VIAL1/7/2012
540NDA/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 VIAL1/7/2012
541NDA/MAL/HDP/1295SHAIGAN PHARMACEUTICALS (PVT) LTDHARLEYS UGANDA LIMITEDZEPARALBENDAZOLE200MGSHAIGAN PHARMACEUTICALS (PVT) LTD-14TH KM, ADYALA ROAD, RAWALPINDI-PAKISTAN PAKISTANORAL SOLID ORDINARY TABLETS1.0X2.0 TABLET BLISTER1/7/1997
542NDA/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 VIAL,1.0X50.0X1.0 VIAL CARTON1/7/2012
543NDA/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 CAPSULES1.0X10.0X10.0 CAPSULE BLISTER1/7/1997
544NDA/MAL/HDP/1304MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDDIAPRIDE PLUS 2GLIMEPIRIDE+ METFORMIN2MG + 500MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER1/7/2012
545NDA/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 BLISTER1/7/2007
546NDA/MAL/HDP/1319REMEDICA LTDGOODMAN INTERNATIONAL LTDZESTAVAL 200 F.C TABLETSALBENDAZOLE200MGREMEDICA LTD-AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE, 3056 LIMASSOL CYPRUSORAL SOLID ORDINARY FILM-COATED TABLETS50.0X2.0 TABLET BLISTER,1.0X2.0 TABLET BLISTER1/7/1997
547NDA/MAL/HDP/1324MACK BROWN PHARMACEUTICALS PVT LIMITEDSHURIK LTDTOOTH HEALMULTI INGREDIENTMULTI INGREDIENTTORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506INDIAORAL LIQUID ORDINARY LIQUIDS1.0X1.0X18.0 ML BOTTLE1/7/2005
548NDA/MAL/HDP/1325MACLEODS PHARMACEUTICALS LTDVITACARE 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 BOTTLE1/7/2016
549NDA/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)1/7/1997
550NDA/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 TUBE1/7/1997
551NDA/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 CONTAINER1/7/2016
552NDA/MAL/HDP/1335INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDPREGATASPREGABALIN75MGINTAS PHARMACEUTICALS LTD-CAMP ROAD SELAQUI DEHRADUNINDIAORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER1/7/2012
553NDA/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 CONTAINER1/7/2015
554NDA/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 VIAL1/7/2016
555NDA/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 CONTAINER1/7/2009
556NDA/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 BLISTER1/7/2010
557NDA/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 BLISTER1/7/2010
558NDA/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 STRIP1/7/2009
559NDA/MAL/HDP/1355PIRAMAL HEALTHCARE LTDMEDIWORLD PHARMA AFRICA LTDSEVOFLURANESEVOFLURANE100% V/VPIRAMAL ENTERPRISES LTD, INDIA-DIGWAL VILLAGE KOHIR MENDAL MEDAK DISTRICT,ANDHRA PRADESH INDIAOTHER SYSTEMIC LIQUID INHALATIONS1.0X250.0 ML BOTTLE1/7/2010
560NDA/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 BLISTER1/7/2016
561NDA/MAL/HDP/1361SWISS PARENTERALS LTDSHREEJI CARE 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 AMPOULE1/7/2016
562NDA/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 TABLETS1.0X2.0X6.0 TABLET STRIP1/7/2013
563NDA/MAL/HDP/1366F. HOFFMANN- LA ROCHE LTDLABOREX UGANDA LIMITEDHERCEPTIN 440MGTRASTUZUMAB440MGF. HOFFMANN LA-ROCHE-WURMISWEG CH-4303 KAISERAUGSTSWITZERLANDPARENTERAL ORDINARY INFUSION DRY VIALS/BOTTLES1.0X440.0 MG VIAL ,2OML VIAL OF SOLVENT1/7/2016
564NDA/MAL/HDP/1367DAWA LIMITEDSUPER MEDIC LTDACEPARACECLOFENAC + PARACETAMOL100 MG + 500 MGDAWA LTD-BABA DOGO ROAD RUARAKAKENYAORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER1/7/2013
565NDA/MAL/HDP/1368ABACUS PARENTERAL DRUGS LIMITEDABACUS 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 BOTTLE1/7/2010
566NDA/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 BLISTER1/7/2016
567NDA/MAL/HDP/1370ABACUS PARENTERAL DRUGS LIMITEDABACUS 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 AMPOULE1/7/2010
568NDA/MAL/HDP/1372AXA PARENTERALS LTDVITACARE LIMITEDRLLACTIC ACID + SODIUM HYDROXIDE + SODIUM CHLORIDE + POTASSIUM CHLORIDE + CALCIUM CHLORIDE(0.24 + 0.115 + 0.6 + 0.04 + 0.027)G/100MLAXA PARENTERALS LTD-KISHNPUR, JAMALPUR ROORKEE- 247677 INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X500.0 ML BOTTLE1/7/2014
569NDA/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 AMPOULE1/7/2014
570NDA/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 TUBE1/7/1997
571NDA/MAL/HDP/1384CIPLA LTD.CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDLAMIVUDINE 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 BOTTLE1/7/2013
572NDA/MAL/HDP/1387INTAS PHARMACEUTICALS LIMITEDNORVIK ENTERPRISES LIMITEDLAN-30LANSOPRAZOLE30MGINTAS PHARMACEUTICALS LTD-CAMP ROAD SELAQUI DEHRADUNINDIAORAL SOLID ORDINARY CAPSULES1.0X1.0X5.0X10.0 CAPSULE STRIP1/7/2004
573NDA/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 BLISTER1/7/2010
574NDA/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 CARTON1/7/1997
575NDA/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 BLISTER1/7/2013
576NDA/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 VIAL1/7/2010
577NDA/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 VIAL1/7/2010
578NDA/MAL/HDP/1397ASTRA ZENECAMACNAUGHTON LIMITEDPLENDILFELODIPINE10MGASTRAZENECA SWEDEN OPERATIONS-ASTRAZENECA SWEDEN OPERATIONS SE-151 85 SODERTALJESWEDENORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET CONTAINER1/7/2001
579NDA/MAL/HDP/1399CIPLA LTD.CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDASTHALINSALBUTAMOL100MCG/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 CANNISTER1/7/2010
580NDA/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 BLISTER1/7/2015
581NDA/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 BLISTER1/7/2015
582NDA/MAL/HDP/1406LEBEN LABORATORIES PVT LTDMALIX PHARMA (U) LIMITEDCEBAY 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 BOTTLE1/7/2014
583NDA/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 BOTTLE1/7/2007
584NDA/MAL/HDP/1411LEBEN LABORATORIES PVT LTDMALIX PHARMA (U) LIMITEDCIPIUMCHLORPHENIRAMINE4MGLEBEN LAB PVT LTD-L4 PHASE 111 MIDCS AKOLA 444104 MAHARASTRA INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X20.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER1/7/2011
585NDA/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 BOTTLE1/7/2014
586NDA/MAL/HDP/1415ASTRA ZENECAMACNAUGHTON LIMITEDATACANDCANDESARTAN32MGASTRA ZENECA SWEDEN OPERATIONS-TABLET PRODUCTION SE-151 85, GARTUNAVAGEN, SODERTALJE
SWEDENORAL SOLID ORDINARY TABLETS1.0X2.0X14.0 TABLET BLISTER1/7/2011
587NDA/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 BLISTER1/7/2001
588NDA/MAL/HDP/1418SHOSAAN ASIC PACIFICRENE PHARMACY LTDAMINOPHYLLINE TABLETSAMINOPHYLLINE100MGNEM LABORATORIES PVT LTD-PLOT NO. 133 KRISHNA IND. ESTATE, VASAI E,DIST PALGHAR- 401210, MAHARASHTRA STATE INDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER1/7/2011
589NDA/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 BLISTER1/7/2005
590NDA/MAL/HDP/1422SHAIGAN PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDSTAMINCETIRIZINE DIHYDROCHLORIDE10MGSHAIGAN PHARMACEUTICALS (PVT) LTD-14TH KM, ADYALA ROAD, RAWALPINDI-PAKISTAN PAKISTANORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER
591NDA/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 BLISTER1/7/2016
592NDA/MAL/HDP/1425LEBEN LABORATORIES PVT.LTDMALIX PHARMA (U) LIMITEDL-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 BOTTLE1/7/2007
593NDA/MAL/HDP/1427GITTOES PHARMACEUTICALS LIMITEDGITTOES 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 BLISTER1/7/2011
594NDA/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 BLISTER1/7/2013
595NDA/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 VIAL1/7/1997
596NDA/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 BLISTER1/7/2014
597NDA/MAL/HDP/1441AXA PARENTERALS LTDVITACARE LIMITEDSODIUM CHLORIDESODIUM CHLORIDE0.9%W/VAXA PARENTERALS LTD-KISHNPUR, JAMALPUR ROORKEE- 247677 INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X500.0 ML BOTTLE1/7/2014
598NDA/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 VIAL1/7/2003
599NDA/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 CONTAINER1/7/2015
600NDA/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 BLISTER1/7/2014
601NDA/MAL/HDP/1449SHAIGAN PHARMACEUTICALS (PVT) LTDHARLEYS UGANDA LIMITEDZEPAR SUSPENSIONALBENDAZOLE200MG/5MLSHAIGAN PHARMACEUTICALS (PVT) LTD-14TH KM, ADYALA ROAD, RAWALPINDI-PAKISTAN PAKISTANORAL LIQUID ORDINARY SUSPENSIONS1.0X10.0 ML BOTTLE1/7/2000
602NDA/MAL/HDP/1450GLAXOSMITHKLINE LIMITED LIKONIUNITED HEALTHCARE DISTRIBUTORS LTDVOLTAREN EMULGEL 1%DICLOFENAC DIETHYLAMMONIUM1%W/VGSK CONSUMER HEALTH SA-GSK CONSUMER HEALTH SA, ROUTE DE L’ETRAZ, NYON, 1260, SWITZERLAND SWITZERLANDTOPICAL EXTERNAL GELS AND SOLS1.0X20.0 G TUBE,1.0X50.0 G TUBE1/7/1997
603NDA/MAL/HDP/1451NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDVOLTAREN INJECTIONDICLOFENAC25MG/MLNOVARTIS PHARMA STEIN AG-SCHAFFHARVSERTRASSE CH-4332 STEIN SWITZERLAND.SWITZERLANDPARENTERAL ORDINARY AMPOULES1.0X3.0 ML AMPOULE1/7/1997
604NDA/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 BLISTER1/7/2016
605NDA/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 STRIP1/7/2003
606NDA/MAL/HDP/1457NABIQASIM INDUSTRIES (PVT) LTD.JEET PHARMACEUTICALS LIMITEDDYSEN FORTESECNIDAZOLE1000MGNABIQASIM INDUSTRIES (PVT) LIMITED-17/24, KORANGI INDUSTRIAL AREA, KARACHI, PAKISTAN PAKISTANORAL SOLID ORDINARY TABLETS1.0X2.0 TABLET BLISTER1/7/2006
607NDA/MAL/HDP/1458STRIDES SHASUN LIMITEDDELMAW ENTERPRISES LIMITEDCLAVICIN INJECTIONAMOXICILLIN + POTASSIUM CLAVULANATE1.2GREYOUNG PHARMACEUTICAL CO. LIMITED-NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA CHINAPARENTERAL ORDINARY DRY VIALS1.0X1.2 G VIAL1/7/2013
608NDA/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 BLISTER1/7/2014
609NDA/MAL/HDP/1460VENUS REMEDIES LTDAARON PHARMACEUTICALS LTDPARIN EENOXAPARIN80MGVENUS REMEDIES LTD --UNIT II HILL TOP INDUSTRIAL ESTATE JHARMAJRI EPIP PHASE I BHATOLI KALAN BADDI (H.P)INDIAPARENTERAL ORDINARY PRE-FILLED SYRINGES1.0X10.0X2.0X0.8 ML PRE- FILLED SYRINGE1/7/2009
610NDA/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 BOTTLE1/7/2015
611NDA/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 BLISTER1/7/2014
612NDA/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 CARTON,9.0X1.0X3.0X3.0 SACHET CARTON1/7/2014
613NDA/MAL/HDP/1468CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDOCID 20OMEPRAZOLE20MG 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 EAST AFRICAN (INDIA) OVERSEAS-PLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIA INDIAORAL SOLID RETARD CAPSULES1.0X10.0X10.0 CAPSULE STRIP1/7/1998
614NDA/MAL/HDP/1474GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGODIC GELDICLOFENAC DIETHYLAMINE1%W/WAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIATOPICAL EXTERNAL GELS AND SOLS1.0X30.0 G TUBE1/7/2016
615NDA/MAL/HDP/1476GITTOES PHARMACEUTICALS LIMITEDGITTOES 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 TUBE1/7/2016
616NDA/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 BLISTER1/7/2001
617NDA/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 NS1/7/1997
618NDA/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 BLISTER1/7/2011
619NDA/MAL/HDP/1488DENK PHARMA GMBH & CO. KGBENLE 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 STRIP1/7/2000
620NDA/MAL/HDP/1492DENK PHARMA GMBH & CO. KGBENLE CONSULT LIMITEDDICLO-DENK 75 INJECTIONDICLOFENAC SODIUM25MG/MLHAUPT PHARMA WULFING GMBH;--BETHELNER LANDSTR. 18, 31028 GRONAULLEIRE, GERMANY. GERMANYPARENTERAL ORDINARY AMPOULES1.0X10.0X3.0 ML AMPOULE1/7/1998
621NDA/MAL/HDP/1493AUROBINDO PHARMA LTD UNIT VIIGITTOES PHARMACEUTICALS LIMITEDKOACT 1000AMOXICILLIN/CLAVULANATE POTASSIUM875MG/125MGAUROBINDO PHARMA LIMITED, UNIT III-SURVEY NO. 313 & 314, BACHUPALLY (MANDAL), MEDCHAL - MALKAJGIRI (DISTRICT) - 500090 TELENGANA (STATE) INDIAORAL SOLID RETARD TABLETS1.0X3.0X5.0 TABLET BLISTER1/7/2007
622NDA/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 TUBE1/7/2013
623NDA/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 STRIP1/7/1997
624NDA/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 TUBE1/7/1997
625NDA/MAL/HDP/1500MSD (PTY) LIMITED SASURGIPHARM (U) LIMITEDATRIPLAEFAVIRENZ+EMTRICITABINE + TENOFOVIR600MG +200MG+300MGPATHEON INC-MISSISSAUGA,ON L5N 7K9 CANADA NETHERLANDSORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET CONTAINER1/7/2008
626NDA/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 CARTON1/7/2007
627NDA/MAL/HDP/1508DAWA LIMITED-SUPER MEDIC LTDWOMNILALBENDAZOLE200MG/5MLDAWA-PLOT 7879, BABA DOGO ROAD RUARAKA, NAIROBI, KENYA KENYAORAL LIQUID ORDINARY SUSPENSIONS1.0X10.0 ML BOTTLE1/7/2009
628NDA/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 BLISTER1/7/2007
629NDA/MAL/HDP/1514JOHNSON&JOHNSON PTY LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDVERMOXMEBENDAZOLE100MGSPECPHARM HOLDINGS- 15TH ROAD HALFWAY HOUSE JOHNSON & JOHNSON (PTY) LTD-241 MAIN ROAD, RETREAT, 7945, CAPE TOWN SOUTH AFRICAORAL SOLID ORDINARY CHEWABLE TABLETS1.0X6.0 TABLET BLISTER1/7/1997
630NDA/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 BLISTER1/7/2011
631NDA/MAL/HDP/1517SHOSAAN ASIC PACIFICRENE 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 TUBE1/7/1998
632NDA/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 BOTTLE1/7/2007
633NDA/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 BOTTLE1/7/2008
634NDA/MAL/HDP/1525CIPLA LIMITED.CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDBENDEXALBENDAZOLE20MG/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 BOTTLE1/7/2007
635NDA/MAL/HDP/1526FERRER INTERNACIONAL S.ALABOREX UGANDA LIMITEDGAMALATE B6MAGNESIUM GLUTAMATE HYDROBROMIDE + AMINOBUTYRIC ACID + AMINO HYDROXYBUTYRIC ACID + VITAMIN B675MG + 75MG + 37MG + 37MGFERRER INTERNATIONAL, S.A.-C/JOAN BUSCALLA, 1-9.08173 SANT CUGAT DEL VALLES, BARCELONA SPAINORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER1/7/2015
636NDA/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 BLISTER1/7/2007
637NDA/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 BLISTER1/7/1997
638NDA/MAL/HDP/1532BF BIOSCIENCES LTDHARLEYS UGANDA LIMITEDNOVAPRESSINTERLIPRESSIN1MG/VIALBF BIOSCIENCES LTD. -RAIWIND,PAKISTAN PAKISTANPARENTERAL ORDINARY VIALS1.0X1.0 MG VIAL1/7/2014
639NDA/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 BOTTLE1/7/2007
640NDA/MAL/HDP/1535ABACUS PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDFORTIWIN-4FORTIFIED PROCAINE PENICILLIN SODIUM4 M.UINJECT CARE PARENTERALS PVT LTD-PLOT NO. 130 SILVASSA ROAD, GIDC VAPI 396195 REYOUNG PHARMACEUTICAL CO. LIMITED-NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA CHINAPARENTERAL ORDINARY DRY VIALS1.0X50.0X4.0 MU VIAL,1.0X100.0X4.0 MU VIAL,1.0X10.0X4.0 MU VIAL1/7/2011
641NDA/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 BOTTLE1/7/2003
642NDA/MAL/HDP/1546UNICHEM LABORATORIES LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDLANPROLANSOPRAZOLE30MGUNICHEM LABORATORIES LTD-UNIT II, VILLAGE BHATAULI KALAN, BADDI SOLAN (HP) 173205 UNICHEM LABORATORIES LTD-PLOT NO. 15,16,17,17A & 18, PILERNE INDUSTRIAL ESTATE, PILERNE, BARDEZ, GOA- 403511 INDIAORAL SOLID ORDINARY CAPSULES1.0X5.0X2.0X10.0 CAPSULE BLISTER1/7/1999
643NDA/MAL/HDP/1549REMINGTON PHARMACEUTICAL INDUS. PVT LTD PAKISTANHEALTHCARE LTD.PREDNICOL EYE DROPSPREDNISOLONE/CHLORAMPHENICOL5MG/2MGREMINGTON PHARMACEUTICAL INDUS. PVT LTD-, 117 ALLAM PAKISTANOPHTHALMIC DROPS1.0X10.0 ML VIAL1/7/1999
644NDA/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 BLISTER1/7/2004
645NDA/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 BOTTLE1/7/2004
646NDA/MAL/HDP/1554ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDAXCEL CETIRIZINECETIRIZINE DIHYDROCHLORIDE5MG/5MLKOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA KESAR PHARMA PVT LTD-PLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARAT MALAYSIAORAL LIQUID ORDINARY SYRUPS1.0X60.0 ML BOTTLE1/7/2010
647NDA/MAL/HDP/1555GALENTIC PHARMA LTDVITACARE LIMITEDGALSCRUBCHLORHEXIDINE4%W/WGALENTIC PHARMA PVT. LIMITED -R-673, TTC MIDC, RUBALE, THANE BELAPUR NAVI MUMBAI 400 701
INDIA
INDIATOPICAL EXTERNAL LIQUIDS1.0X500.0 ML BOTTLE1/7/2008
648NDA/MAL/HDP/1556VIRBAC RSA (PTY) LTDMETRO PHARMACEUTICALS LIMITEDVOMISTATONDASENTRON2MG/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 AMPOULE1/7/2014
649NDA/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)1/7/2010
650NDA/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 BLISTER1/7/2003
651NDA/MAL/HDP/1561LINCOLN P'CALS LTDMETRO PHARMACEUTICALS LIMITEDNEOVAGNYSTATIN10000IULINCOLN PHARMACEUTICALS LTD-10, 11, 13, TRIMUL ESTATE KHATRAJ, NEAR KHATRAJ, CHOKADI , KHATRAJ-382721, GHANDINAGAR GUJARAT, INDIA
INDIAVAGINAL TABLETS1.0X14.0 PESSARY STRIP1/7/2004
652NDA/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 BOTTLE1/7/1997
653NDA/MAL/HDP/1566GITTOES PHARMACEUTICALS 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 NULLORAL SOLID ORDINARY OTHER COATED TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER1/7/2009
654NDA/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)1/7/2013
655NDA/MAL/HDP/1572SUN PHARMACEUTICAL INDUSTRIES LIMITEDSTAR PHARMACEUTICALS LTDROSUVAS 20ROSUVASTATIN20MGSUN PHARMACEUTICAL INDUSTRIES LIMITED (FORMERLY RANBAXY LABORATORIES LIMITED)-VILLAGE GANGUWALA. PAONTA SAHIB DISTRICT SIRMOUR - 173025 (H.P), INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X2.0X7.0 TABLET BLISTER1/7/2011
656NDA/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 BLISTER1/7/2003
657NDA/MAL/HDP/1577SEARLE PAKISTAN LTDHEALTHCARE LTD.SPIROMIDESPIRONOLACTONE + FRUSEMIDE50MG+20MGTHE SEARLE COMPANY-32-KM MULTAN ROAD, LAHORE INDIAORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET STRIP1/7/2005
658NDA/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 AMPOULE1/7/2011
659NDA/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 BLISTER1/7/2006
660NDA/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 BLISTER1/7/2005
661NDA/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 BLISTER1/7/2010
662NDA/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 BOTTLE1/7/1997
663NDA/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 BOTTLE1/7/1997
664NDA/MAL/HDP/1598GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOCIM 400CIMETIDINE400MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER1/7/2005
665NDA/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 CONTAINER1/7/2001
666NDA/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 BLISTER1/7/2005
667NDA/MAL/HDP/1616GITTOES PHARMACEUTICALS 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 BOTTLE1/7/2011
668NDA/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 TUBE1/7/2004
669NDA/MAL/HDP/1629INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDCARVETAS 12.5CARVEDILOL12.5MGINTAS PHARMACEUTICALS LIMITED -CAMP ROAD, SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER1/7/2011
670NDA/MAL/HDP/1631AUROBINDOM PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDNEVIRAPINE ORAL SUSPENSIONNEVIRAPINE50MG/5MLAUROBINDO PHARMA LTD, UNIT III -SURVEY NO. 313, 314 BACHUPALLY (VILLAGE) QUTHUBULLAPUR (MANDAL) RR DISTRICT HYDERABAD ANDHRA PRADESH 500090 INDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X240.0 ML BOTTLE,1.0X100.0 ML BOTTLE1/7/2007
671NDA/MAL/HDP/1632: ALKEM LABORATORIES LIMITED√ABACUS PHARMA (AFRICA) LIMITEDCLAVAM 1.2GAMOXICILLIN SODIUM + CLAVULANATE POTASSIUM1000MG +200MG ALKEM LABORATORIES LTD .,.-VILLAGE THANA BADDI DIST-SOLAN TEHSIL NALAGARH HIMACHAL PRADESH 173205 INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0 VIAL CARTON + 1 AMPOULE OF WFI1/7/2005
672NDA/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 VIAL1/7/1997
673NDA/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 BLISTER1/7/2005
674NDA/MAL/HDP/1639GLAXO SMITHLINE LIMITEDUNITED HEALTHCARE DISTRIBUTORS LTDPANADOL EXTRA WITH OPTIZORBPARACETAMOL + CAFFEINE500MG + 65MGGLAXOSMITHKLINE LIMITED - -78392-00507, VIWANDANI LIKONI ROAD NAIROBI KENYA GRANULES INDIA LIMITED-SY. NO. 160/A, 161/E, 162 & 174/A GAGILLAPUR VILLAGE, DUNDIGAL-GANDIMAISAMMA MANDAL, MEDCHAL - MALKHAJGIRI DISTRICT - 500043 TELENGANA KENYAORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CARTON1/7/2003
675NDA/MAL/HDP/1642UMEDICA LABORATORIES PVT LTDVITACARE 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 VIAL1/7/2004
676NDA/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 BLISTER1/7/2002
677NDA/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 BLISTER1/7/2006
678NDA/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 STRIP1/7/2009
679NDA/MAL/HDP/1656AIVEEN (U) LIMITEDAIVEEN (U) 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 BLISTER1/7/2015
680NDA/MAL/HDP/1660GITTOES PHARMACEUTICALS 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 STRIP1/7/2005
681NDA/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 CONTAINER1/7/2007
682NDA/MAL/HDP/1663MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDALCID-PINKALUMINIUM HYDROXIDE/MAGNESIUM TRISILICATE400MG+400MG/50MLTORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506INDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X400.0 ML BOTTLE,1.0X160.0 ML BOTTLE1/7/2003
683NDA/MAL/HDP/1673GLAXO SMITH KLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDAMOXILAMOXYCILLIN250MGGLAXO WELLCOME PRODUCTION -Z.I DE LA PEYENNIERE 53100 MAYENNE FRANCE GLAXO WELLCOME PRODUCTION-ZI DE LA PEYENNIERE, 53100, MAYENNE FRANCEORAL SOLID ORDINARY CAPSULES10.0X10.0 CAPSULE BLISTER1/7/1997
684NDA/MAL/HDP/1675MERCK SHARP & DOHME BVSURGIPHARM (U) 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)1/7/2007
685NDA/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 BLISTER1/7/1997
686NDA/MAL/HDP/1679LEBEN LABORATORIES PVT. LTDMALIX PHARMA (U) LIMITEDCIPROLEBCIPROFLOXACIN500MGLEBEN 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 BLISTER1/7/2007
687NDA/MAL/HDP/1680SHOSAAN ASIC PACIFICRENE PHARMACY LTDH-CORTHYDROCORTISONE0.1%W/WNEM LABORATORIES PVT LTD-PLOT NO. 133 KRISHNA IND. ESTATE, VASAI E,DIST PALGHAR- 401210, MAHARASHTRA STATE INDIATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE1/7/1997
688NDA/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 BLISTER1/7/2005
689NDA/MAL/HDP/1685LINCOLN P'CALS LTDMETRO PHARMACEUTICALS LIMITEDKONAZOLKETOCONAZOLE200MGLINCOLN 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,1.0X3.0X10.0 TABLET BLISTER1/7/2005
690NDA/MAL/HDP/1689SK AGE EXPORTSABACUS PHARMA (AFRICA) LIMITEDOMESKOMEPRAZOLE20MGS.KANT HEALTHCARE LTD-PLOT 1802, 1805, GIDC PHASE III VAPI 39179, GUJARAT INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE STRIP1/7/2010
691NDA/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 BOTTLE1/7/2004
692NDA/MAL/HDP/1691WIDE SPECTRUM ENTERPRISES (U) LIMITEDWIDE SPECTRUM ENTERPRISES (U) LIMITEDZITHRORIVAZITHROMYCIN500MGRIVA PHARMA FREE ZONE-NASR CITY CAIRO EGYPTEGYPTORAL SOLID ORDINARY CAPSULES1.0X3.0 CAPSULE BLISTER1/7/2011
693NDA/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 BOTTLE1/7/2007
694NDA/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 TUBE1/7/2005
695NDA/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 BLISTER1/7/2005
696NDA/MAL/HDP/1698CIPLA LTD.CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDAZEE-500AZITHROMYCIN500MGCIPLA LTD ;-VILLAGE UPPER MALPUR P.O BHUD THE NALAGARH DIST. SOLAN HIMACHAL PRADESH PIN 173205 CIPLA LTD.-VERNA IND. ESTATE GOA 403 722 INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X1.0X3.0 TABLET BLISTER1/7/2009
697NDA/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 BLISTER1/7/2014
698NDA/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 TUBE1/7/2005
699NDA/MAL/HDP/1704DAFRA PHARMA LTDMULTIPHAR UGANDA LIMITEDDAFRACLAVAMOXYCILLIN + POTASSIUM CLAVULANATE500MG + 125MGBILIM ILAC SAN. VE. TIC. A.S.-CERKEZKOY ORGANIZE SANAYI BOLGESI, KARAAGAC, MH. 5. SK. NO. 6, KAPAKLI - TEKIRDAG 59510 TURKEYORAL SOLID ORDINARY TABLETS1.0X3.0X5.0 TABLET BLISTER1/7/2011
700NDA/MAL/HDP/1707XEPA SOUL PATTISON (M) SDN BHDDELMAW ENTERPRISES LIMITEDFEBRICOL TABLETSPARACETAMOL / PSEUDOEPHEDRINE / CHLORPHENIRAMINE500MG / 30MG /2MGXEPA-SOUL PATTINSON (MALAYSIA) SDN BLD -1-5 CHENG INDUSTRIAL ESTATE, 75250
MALEKA, MALAYSIA
MALAYSIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X2.0X10.0 TABLET BLISTER1/7/1997
701NDA/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 BLISTER1/7/1997
702NDA/MAL/HDP/1709REGAL PHARMA U LIMITEDREGAL 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 TUBE1/7/1997
703NDA/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 CONTAINER1/7/1997
704NDA/MAL/HDP/1713MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDLUMITERARTEMETHER + LUMEFANTRINE20 MG + 120 MGMACLEODS PHARMACEUTICALS LTD -BLOCK N2, VILLAGE THEDA, P.O. LODHI MAJRA, TEHSIL BADDI, DIST. SOLAN, HIMACHAL PRADESH 174101 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 BLISTER1/7/2007
705NDA/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 KENYAORAL LIQUID ORDINARY SYRUPS1.0X1.0X100.0 ML BOTTLE1/7/2011
706NDA/MAL/HDP/1716ACULIFE HEALTHCARE PVT LTDASTRA PHARMA (U) 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 BOTTLE1/7/2010
707NDA/MAL/HDP/1719ACULIFE HEALTHCARE PVT LTDASTRA PHARMA (U) 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 BOTTLE1/7/2010
708NDA/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 BOTTLE1/7/2000
709NDA/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 CANNISTER1/7/2009
710NDA/MAL/HDP/1725REMEDICA LTDGOODMAN INTERNATIONAL LTDMYCORIL CREAM 1%CLOTRIMAZOLE1%W/WREMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR CYPRUSTOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE1/7/2000
711NDA/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 STRIP1/7/2007
712NDA/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 BLISTER1/7/2008
713NDA/MAL/HDP/1731REGAL PHARMA U LIMITEDREGAL 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 TUBE1/7/1997
714NDA/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 CONTAINER1/7/1997
715NDA/MAL/HDP/1736MEDOCHEMIE LTDLABOREX UGANDA LIMITEDKLERIMEDCLARITHROMYCIN500MGMEDOCHEMIE (FACTORY AZ).-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA, 4101 AGIOS ATHANASSIOS, LIMASSOL CYPRUSORAL SOLID ORDINARY TABLETS1.0X2.0X7.0 TABLET BLISTER1/7/2009
716NDA/MAL/HDP/1738ALCON PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.TEARS NATURALE IINATURAL TEARS15MLALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUM BELGIUMOPHTHALMIC DROPS1.0X15.0 ML BOTTLE1/7/1997
717NDA/MAL/HDP/1739MEDOCHEMIE LTDLABOREX UGANDA LIMITEDMELOXMELOXICAM15MG MEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA CYPRUSORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER1/7/2009
718NDA/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 VIAL1/7/2005
719NDA/MAL/HDP/1743MEDOCHEMIE LTDLABOREX UGANDA LIMITEDDAPRILLISINOPRIL DIHYDRATE10MGMEDOCHEMIE (FACTORY AZ).-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA, 4101 AGIOS ATHANASSIOS, LIMASSOL CYPRUSORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER1/7/2009
720NDA/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 VIAL1/7/2005
721NDA/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 AMPOULE1/7/2005
722NDA/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 VIAL1/7/2005
723NDA/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 AMPOULE1/7/2005
724NDA/MAL/HDP/1753PHARMATEC PAKISTAN PVT LTDHEALTHCARE LTD.FLU-GONE-P. PLUS SYRUPPARACETAMOL + PSEUDOEPHEDRINE HCL + CHLORPHENIRAMINE MALEATE120MG/5ML + 15MG/5ML + 1MG/5MLPHARMATEC PKISTAN (PVT) LTD-D - 86 / A S.I.T.E KARACHI, PAKISTAN INDIAORAL LIQUID ORDINARY SYRUPS1.0X1.0X120.0 ML BOTTLE1/7/2013
725NDA/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 VIAL1/7/2005
726NDA/MAL/HDP/1756AMMAN PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDAPICROM 2%SODIUM CROMOGLYCATE2%W/VAMMAN PHARMACEUTICALS INDUSTRIES .-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDAN JORDANOPHTHALMIC DROPS1.0X1.0X10.0 ML VIAL1/7/2005
727NDA/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 VIAL1/7/2005
728NDA/MAL/HDP/1759SHAIGAN PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDAMLOPINAMLODIPINE5MGSHAIGAN PHARMACEUTICALS (PVT) LTD-14TH KM, ADYALA ROAD, RAWALPINDI-PAKISTAN PAKISTANORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER
729NDA/MAL/HDP/1760AMMAN PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDNEODEXNEOMYCIN +DEXAMETHASONE0.5%W/V + 0.1%W/VAMMAN PHARMACEUTICALS INDUSTRIES-AMMAN PHARMACEUTICAL INDUSTRIES-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDAN JORDANOTIC DROPS1.0X1.0X10.0 ML VIAL1/7/2005
730NDA/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 BOTTLE1/7/2014
731NDA/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 VIAL1/7/2005
732NDA/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 CONTAINER1/7/1997
733NDA/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 CONTAINER1/7/2006
734NDA/MAL/HDP/1765UMEDICA LABORATORIES PVT LTDVITACARE 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 BLISTER1/7/2012
735NDA/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 BLISTER1/7/2005
736NDA/MAL/HDP/1767EVA PHARMA FOR PHARMACEUTICALS & MEDICAL APPLIANCES -WIDE SPECTRUM ENTERPRISES (U) LIMITEDPROSTETROLALFUZOSIN 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 BLISTER,1.0X3.0X10.0 TABLET BLISTER1/7/2013
737NDA/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)1/7/1997
738NDA/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 BLISTER1/7/2000
739NDA/MAL/HDP/1777CIPLA LTD.CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDNUZAC 20FLUOXETINE20MGCIPLA LTD ..-PLOT NO. 910 & 15 INDORE SPECIAL ECONOMIC ZONE PHASE II PITHAMPUR DISTRICT DHAR MADHYA PRADESH 454775 CIPLA LTD -PLOT NO. L-139, VERNA, GOA 403 722 INDIA INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER1/7/2003
740NDA/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 BLISTER1/7/1998
741NDA/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 BOTTLE,1.0X500.0 ML BOTTLE1/7/1999
742NDA/MAL/HDP/1780RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDRENETRIM SUSPENSIONCO-TRIMOXAZOLE240MG/5MLRENE INDUSTRIES LIMITED-PLOT 680 KAMULI KIREKAUGANDAORAL LIQUID ORDINARY SUSPENSIONS1.0X60.0 ML BOTTLE1/7/2000
743NDA/MAL/HDP/1781ASTRAZENECAMACNAUGHTON LIMITEDARIMIDEXANASTROZOLE1MGASTRAZENECA PHARMACEUTICALS LP-NEWARK, DELAWARE UNITED STATESORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X14.0 TABLET BLISTER1/7/2000
744NDA/MAL/HDP/1782GITTOES PHARMACEUTICALS LIMITEDGITTOES 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 BOTTLE1/7/2010
745NDA/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 TUBE1/7/1997
746NDA/MAL/HDP/1784MACLEODS PHARMACEUTICALS LTDVITACARE 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 BLISTER1/7/2005
747NDA/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 BLISTER1/7/1997
748NDA/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 CONTAINER1/7/1997
749NDA/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 BLISTER1/7/2013
750NDA/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 CONTAINER1/7/1997
751NDA/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 INDIA AJANTA PHARMA LIMITED-PLOT NO.Z/103/A,DAHEJ SEZ PART 11,DISTRICT: BHARUCH,GUJARAT-392130 INDIAORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER,1.0X10.0X1.0X6.0 TABLET BLISTER1/7/2006
752NDA/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 VIAL1/7/2010
753NDA/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 BLISTER1/7/1997
754NDA/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 BLISTER1/7/2001
755NDA/MAL/HDP/1800MICRO LABS LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDAMLONG-10AMLODIPINE10MGMICRO 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 BLISTER1/7/2009
756NDA/MAL/HDP/1801LABORATORY&ALLIED LTDHARLEYS UGANDA LIMITEDLABESTEN PESSARIESCLOTRIMAZOLE100MGLABORATORY & ALLIED LTD.---PLOT 209/10349 OFF MOMBASA RD NAIROBIKENYAVAGINAL TABLETS1.0X1.0X6.0 PESSARY STRIP1/7/1997
757NDA/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 CARTON1/7/2001
758NDA/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 BLISTER1/7/2001
759NDA/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 BOTTLE1/7/1997
760NDA/MAL/HDP/1810GITTOES PHARMACEUTICALS 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 CONTAINER1/7/2010
761NDA/MAL/HDP/1811CIPLA LTD.CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDDUOVIR TABLETSZIDOVUDINE+ LAMIVUDINE300MG + 150MG CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED - -PLOT 1-7 1ST RING ROAD, LUZIRA, KAMPALA UGANDAORAL SOLID ORDINARY TABLETS1.0X6.0X10.0 TABLET BLISTER,1.0X60.0 TABLET BOTTLE1/7/2001
762NDA/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 BLISTER1/7/2001
763NDA/MAL/HDP/1813DAWA LIMITEDSUPER MEDIC LTDMOXAFORTEAMOXICILLIN + FLUCLOXACILLIN125 MG + 125MGDAWA LTD-BABA DOGO ROAD RUARAKAKENYAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE1/7/2014
764NDA/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 TUBE,1.0X5.0 G TUBE1/7/2003
765NDA/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 TUBE1/7/1998
766NDA/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 STRIP1/7/1997
767NDA/MAL/HDP/1822RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDEPHEDRINEEPHEDRINE HYDROCHLORIDE30MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA UGANDAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER1/7/2005
768NDA/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 BOTTLE1/7/2005
769NDA/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 BOTTLE1/7/2006
770NDA/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 BLISTER1/7/2011
771NDA/MAL/HDP/1841MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDFUNGNIL CREAMCLOTRIMAZOLE1%W/WTORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506INDIATOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE1/7/2000
772NDA/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 BLISTER1/7/2002
773NDA/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 BLISTER1/7/2005
774NDA/MAL/HDP/1844GUILIN PHARMACEUTICALS CO.LTDTRIDEM PHARMA UGANDA LIMITEDSULFAMETHOXAZOLE / 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 CONTAINER1/7/2011
775NDA/MAL/HDP/1846LEBEN LABORATORIES PVT LTDMALIX PHARMA (U) LIMITEDANTAGIT 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 BOTTLE1/7/2013
776NDA/MAL/HDP/1847MICRO LABSMALIX PHARMA (U) LIMITEDMOXILEB-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 BLISTER1/7/2007
777NDA/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 BLISTER1/7/1997
778NDA/MAL/HDP/1849ABACUS PARENTERAL DRUGS LIMITEDABACUS 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 BOTTLE1/7/2011
779NDA/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 CONTAINER,1.0X1000.0 TABLET CONTAINER1/7/2010
780NDA/MAL/HDP/1851PRISMA PHARMA FZEPHILLIPS 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 TUBE1/7/2011
781NDA/MAL/HDP/1852SUN PHARMACEUTICAL INDUSTRIES LIMITED -STAR PHARMACEUTICALS LTDVERCEF ORAL SUSPENSIONCEFACLOR125MG/5MLRANBAXY LABORATORIES-LABORATORIES LIMITED INDUSTRIAL AREA 3 DEWAS 455001INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE1/7/1997
782NDA/MAL/HDP/1853MSD (PTY) LIMITED SASURGIPHARM (U) LIMITEDAERIUS ORAL SOLUTIONDESLORATADINE0.5MG/ML MSD (PTY) LTD- LOCATED AT 117 16TH ROAD HALFWAY HOUSE SOUTH AFRICA SCHERING-PLOUGH LABO N.V--INDUSTRIE PARK 30, ZONE A 2220 HEIST-OP-DEN-BERG BELGIUMORAL LIQUID ORDINARY SYRUPS1.0X1.0X60.0 ML BOTTLE,1.0X150.0 ML BOTTLE1/7/2007
783NDA/MAL/HDP/1854ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDFUROSEMIDE INJECTIONFUROSEMIDE10MG/MLREYOUNG PHARMACEUTICAL CO. LIMITED-NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA CHINAPARENTERAL ORDINARY AMPOULES1.0X10.0X2.0 ML AMPOULE,1.0X100.0X2.0 ML AMPOULE1/7/2004
784NDA/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 BLISTER1/7/1998
785NDA/MAL/HDP/1861GUILIN PHARMACEUTICALS CO LTDTRIDEM PHARMA UGANDA LIMITEDSULFAMETHOXAZOLE / 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 CONTAINER1/7/2011
786NDA/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 TUBE1/7/2004
787NDA/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 VIAL1/7/2009
788NDA/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 CONTAINER1/7/2007
789NDA/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 BLISTER1/7/2004
790NDA/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 BLISTER1/7/2004
791NDA/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 BLISTER1/7/2004
792NDA/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 BLISTER1/7/2004
793NDA/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 BLISTER1/7/1997
794NDA/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 CARTON1/7/1997
795NDA/MAL/HDP/1891MACLEODS PHARMACEUTICALS LTDVITACARE 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 BLISTER1/7/2005
796NDA/MAL/HDP/1892MACLEODS PHARMACEUTICALS LTDVITACARE 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 BLISTER1/7/2012
797NDA/MAL/HDP/1895GITTOES PHARMACEUTICALS LIMITEDGITTOES 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 BLISTER1/7/2007
798NDA/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 BLISTER1/7/2001
799NDA/MAL/HDP/1900GITTOES PHARMACEUTICALS LIMITEDGITTOES 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 STRIP1/7/2007
800NDA/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 BOTTLE1/7/2013
801NDA/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 BLISTER1/7/1997
802NDA/MAL/HDP/1905ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDOXYTOCIN INJECTIONOXYTOCIN10I.U/ML KIVIPHARM CO. LTD-NO.5 HANGTIAN STREET DONGSHAN HIGH-TECH INDUSTRIAL DEVELOPMENT ZONE, SHALINGZI TOWN ZHANGJIAKOU CITY, HEBEI PROVINCE CHINAPARENTERAL ORDINARY AMPOULES1.0X10.0X1.0 ML AMPOULE,1.0X100.0X1.0 ML AMPOULE1/7/2007
803NDA/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 BLISTER1/7/1998
804NDA/MAL/HDP/1912MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDD-WORMALBENDAZOLE200MGTORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506INDIAORAL SOLID ORDINARY TABLETS1.0X2.0 TABLET BLISTER1/7/2008
805NDA/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 CONTAINER1/7/2003
806NDA/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 TUBE1/7/1999
807NDA/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 REYOUNG PHARMACEUTICAL CO. LIMITED-NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER1/7/1997
808NDA/MAL/HDP/1921SHAIGAN PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDANTIMINLORATIDINE10MGSHAIGAN PHARMACEUTICALS (PVT) LTD-14TH KM, ADYALA ROAD, RAWALPINDI-PAKISTAN PAKISTANORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER
809NDA/MAL/HDP/1922IPCA LABORATORIESMEDVIN PHARMA LIMITEDAZIFAST-500AZITHROMYCIN500MG IPCA LABORATORIES LTD,PLOT NO. T-139 -SEJAVTA, RATLAM-457 002 (M.P.) INDIA IPCA LABORATORIES LTD, PLOT NO. T-139-PLOT NO. T-139, MIDC, INDUSTRIAL ESTATE, TARAPUR, BOISOR, DIST- PALGHAR, THANE 401506, MAHARASHTRA. INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X3.0 TABLET BLISTER1/7/2007
810NDA/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 VIAL1/7/2013
811NDA/MAL/HDP/1927REGAL PHARMA U LIMITEDREGAL 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 BLISTER1/7/1997
812NDA/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 BLISTER,1.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER1/7/2013
813NDA/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 BLISTER1/7/2012
814NDA/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 IMPLANT1/7/2010
815NDA/MAL/HDP/1934RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDRENECHLOR SUSPENSIONCHLORAMPHENICOL125MG/5MLRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA UGANDAORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE1/7/2001
816NDA/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 CONTAINER1/7/2005
817NDA/MAL/HDP/1940REMEDICA LTDGOODMAN INTERNATIONAL LTDCLOXACILLIN CAPSULESCLOXACILLIN SODIUM250MGREMEDICA LTD-AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE, 3056 LIMASSOL CYPRUSORAL SOLID ORDINARY CAPSULES10.0X10.0 CAPSULE BLISTER1/7/2001
818NDA/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 VIAL1/7/2005
819NDA/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 CONTAINER1/7/2009
820NDA/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 CONTAINER1/7/2009
821NDA/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 STRIP1/7/1998
822NDA/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 BLISTER1/7/1998
823NDA/MAL/HDP/1949MACLEODS PHARMACEUTICALS LTDS LTDVITACARE 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 BLISTER1/7/2011
824NDA/MAL/HDP/1951MACLEODS PHARMACEUTICALS LTDVITACARE 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 STRIP1/7/2006
825NDA/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 STRIP1/7/2011
826NDA/MAL/HDP/1956MILAN LABORATORIES LTDGITTOES PHARMACEUTICALS LIMITEDMILOXYAMOXYCILLIN250MGMILAN LABORATORIES (INDIA) PVT LTD-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 CONTAINER1/7/2006
827NDA/MAL/HDP/1958MILAN LABORATORIES LTDGITTOES PHARMACEUTICALS LIMITEDMILOXYAMOXYCILLIN125MG/5MLMILAN LABORATORIES (INDIA) PVT LTD-PLOT NOS 63, 67 & 87, JAWAHAR CO-OP. INDUSTRIAL
ESTATE LTD., KAMOTHE, PANVEL (NAVI MUMBAI).
INDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE1/7/2005
828NDA/MAL/HDP/1959MILAN LABERATORIES PVT LTDGITTOES PHARMACEUTICALS LIMITEDBETRIM 480CO-TRIMOXAZOLE480MGMILAN LABORATORIES (INDIA) PVT LTD-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 BLISTER1/7/2005
829NDA/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 BLISTER1/7/2003
830NDA/MAL/HDP/1963MILAN LABERATORIES PVT LTDGITTOES PHARMACEUTICALS LIMITEDDICLOFENAC GELDICLOFENAC1%W/WMILAN LABORATORIES (INDIA) PVT LTD-PLOT NOS 63, 67 & 87, JAWAHAR CO-OP. INDUSTRIAL
ESTATE LTD., KAMOTHE, PANVEL (NAVI MUMBAI).
INDIATOPICAL EXTERNAL GELS AND SOLS1.0X35.0 G TUBE1/7/2006
831NDA/MAL/HDP/1964MILAN LABORATORIES LTDGITTOES PHARMACEUTICALS LIMITEDCLONEXCLOTRIMAZOLE1%W/WMILAN LABORATORIES (INDIA) PVT LTD-PLOT NOS 63, 67 & 87, JAWAHAR CO-OP. INDUSTRIAL
ESTATE LTD., KAMOTHE, PANVEL (NAVI MUMBAI).
INDIATOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE1/7/2007
832NDA/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 BLISTER1/7/2005
833NDA/MAL/HDP/1969NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDVOLTAREN SR 75MGDICLOFENAC SODIUM75MGNOVARTIS PHARMA SPA, TORRE ANNUNZIATA ITALY-NA ITALYORAL SOLID RETARD TABLETS1.0X30.0 TABLET CONTAINER1/7/1997
834NDA/MAL/HDP/1970MACK BROWN PHARMACEUTICALS PVT LIMITEDSHURIK LTDCETRAMACCETIRIZINE10MGTORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER1/7/2005
835NDA/MAL/HDP/1971GITTOES PHARMACEUTICALS 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 BOTTLE1/7/1998
836NDA/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 BLISTER1/7/2013
837NDA/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 TUBE1/7/2007
838NDA/MAL/HDP/1977UNICHEM LABORATORIES LTDEUROPA HEALTHCARE (U) LTDLOSAR-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 BLISTER1/7/2011
839NDA/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 BLISTER1/7/2004
840NDA/MAL/HDP/1989FERRER INTERNACIONAL S.ALABOREX UGANDA LIMITEDDERMOFIXSERTACONAZOLE NITRATE2%W/WFERRER INTERNATIONAL, S.A.-C/JOAN BUSCALLA, 1-9.08173 SANT CUGAT DEL VALLES, BARCELONA SPAINTOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE1/7/2014
841NDA/MAL/HDP/1990UNICHEM LABORATORIES LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDTAGERA FORTESECNIDAZOLE1GUNICHEM LABORATORIES LTD-UNIT II, VILLAGE BHATAULI KALAN, BADDI SOLAN (HP) 173205 UNICHEM LABORATORIES LTD---C31 & 32 INDUSTRIAL AREA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X1.0X2.0 TABLET BLISTER1/7/2005
842NDA/MAL/HDP/1997GITTOES PHARMACEUTICALS LIMITEDGITTOES 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 BLISTER,1.0X1000.0 TABLET JAR (WITH STATEMENT "FOR HOSPITAL USE ONLY".)1/7/2011
843NDA/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 BLISTER1/7/2000
844NDA/MAL/HDP/2000TORRENT PHARAMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.CALCIGARD RETARDNIFEDIPINE(SR)20MGTORRENT PHARMACEUTICALS LTD-INDRAD-382721, TAL KADI, AHMEDABAD, INDIA INDIAORAL SOLID RETARD TABLETS1.0X2.0X5.0X10.0 TABLET BLISTER1/7/2000
845NDA/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 BLISTER1/7/2005
846NDA/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 TUBE1/7/2004
847NDA/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 BOTTLE1/7/2010
848NDA/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 BOTTLE1/7/2004
849NDA/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 TUBE1/7/2009
850NDA/MAL/HDP/2016GLENMARK PHARMACUTICALS LTDSTAR PHARMACEUTICALS LTDCANDID CREAMCLOTRIMAZOLE1%W/WGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D INDIATOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE1/7/2000
851NDA/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 BOTTLE1/7/1997
852NDA/MAL/HDP/2019GITTOES PHARMACEUTICALS 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 BLISTER1/7/2011
853NDA/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 CONTAINER1/7/1997
854NDA/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 BLISTER1/7/2000
855NDA/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 BOTTLE1/7/1997
856NDA/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 STRIP1/7/2004
857NDA/MAL/HDP/2025REGAL PHARMA U LIMITEDREGAL 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 BOTTLE1/7/1997
858NDA/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 BLISTER1/7/2009
859NDA/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 BLISTER1/7/2013
860NDA/MAL/HDP/2028SEARLE PAKISTAN LIMITEDHEALTHCARE LTD.SELANZ - SRLANSOPRAZOLE30MGSEARLE PAKISTAN LIMITED-PLOT 35KM, MULTAN ROAD, LAHORE - PAKISTAN PAKISTANORAL SOLID ORDINARY CAPSULES1.0X1.0X7.0 CAPSULE BLISTER1/7/2005
861NDA/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 STRIP1/7/2009
862NDA/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 BLISTER1/7/2004
863NDA/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 CARTRIDGE1/7/1998
864NDA/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 BLISTER1/7/2006
865NDA/MAL/HDP/2042SHOSAAN ASIC PACIFICRENE PHARMACY LTDBURNCURESILVER SULFADIAZINE1%W/WNEM LABORATORIES PVT LTD-PLOT NO. 133 KRISHNA IND. ESTATE, VASAI E,DIST PALGHAR- 401210, MAHARASHTRA STATE INDIATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE1/7/1997
866NDA/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 STRIP1/7/1998
867NDA/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 BLISTER1/7/2005
868NDA/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 BOTTLE1/7/2011
869NDA/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 BLISTER1/7/2005
870NDA/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 BLISTER1/7/2005
871NDA/MAL/HDP/2055SHANGHAI FOSUN PHARMACEUTICAL DEVELOPMENT CO. LTDTRIDEM PHARMA UGANDA LIMITEDARTESUNARTESUNATE120MGGUILIN PHARMACEUTICAL CO. LTD.-NO. 43 QILIDIAN ROAD, GUILIN 541004 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 CHLORIDE1/7/2011
872NDA/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 BOTTLE1/7/1997
873NDA/MAL/HDP/2058MACLEODS PHARMACEUTICALS LTDVITACARE 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 CONTAINER1/7/2006
874NDA/MAL/HDP/2062SHELYS PHARMACEUTICALS LTDBETA HEALTHCARE UGANDA LIMITEDMUCOLYN PAEDIATRIC SYRUPDEXTROMETHORPHAN HYDROBROMIDE BP + CHLORPHENIRAMINE MALEATE BP + AMMONIUM CHLORIDE BP + PSEUDOEPHEDRINE HYDROCHLORIDE BP(5MG + 2MG + 50MG + 10MG)/ 5MLBETA HEALTHCARE INTERNATIONAL LTD -PLOT NO LR 209/6534 MOGADISHU ROADKENYAORAL LIQUID ORDINARY SYRUPS1.0X1.0X100.0 ML BOTTLE1/7/2006
875NDA/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 BLISTER1/7/1997
876NDA/MAL/HDP/2066REMEDICA LTDGOODMAN INTERNATIONAL LTDMETHOTREXATEMETHOTREXATE2.5MGREMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR CYPRUSORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER1/7/2005
877NDA/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 BLISTER1/7/1999
878NDA/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 BLISTER1/7/1999
879NDA/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 TUBE1/7/2010
880NDA/MAL/HDP/2070BAYER PHARMA AGSURGIPHARM (U) LIMITEDMIRENALEVONORGESTREL52MGBAYER OY-PANSIONATE 47 20210 TURKU FINLANDFINLANDPARENTERAL RETARD IMPLANTS1.0X1.0 IMPLANT CARTON1/7/2009
881NDA/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 BOTTLE1/7/2000
882NDA/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 INJECTION1/7/1997
883NDA/MAL/HDP/2074GITTOES PHARMACEUTICALS 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 BOTTLE1/7/1998
884NDA/MAL/HDP/2075GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOPREDPREDNISOLONE5MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER1/7/2006
885NDA/MAL/HDP/2076GITTOES PHARMACEUTICALS LIMITEDGITTOES 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 BLISTER1/7/2006
886NDA/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 BOTTLE1/7/2007
887NDA/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)1/7/2015
888NDA/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 BOTTLE1/7/2013
889NDA/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 BLISTER1/7/2005
890NDA/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 TUBE1/7/2001
891NDA/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 STRIP1/7/1999
892NDA/MAL/HDP/2098GITTOES PHARMACEUTICALS LIMITEDGITTOES 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 BLISTER1/7/2006
893NDA/MAL/HDP/2099XEPA SOUL PATTISON (M) SDN BHDDELMAW ENTERPRISES LIMITEDHYDROCORTISONE 1% CREAMHYDROCORTISONE1%W/WXEPA-SOUL PATTINSON (MALAYSIA) SDN BHD-1-5 CHENG INDUSTRIAL ESTATE, 75250
MALEKA, MALAYSIA
MALAYSIATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE1/7/1998
894NDA/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 BLISTER1/7/2010
895NDA/MAL/HDP/2102MEDREICH PLCSURGIPHARM (U) 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 BLISTER1/7/2006
896NDA/MAL/HDP/2103MEDREICH PLCSURGIPHARM (U) 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 BLISTER1/7/2006
897NDA/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 BOTTLE1/7/2009
898NDA/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 CONTAINER1/7/2011
899NDA/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 CONTAINER1/7/2008
900NDA/MAL/HDP/2116MACLEODS PHARMACEUTICALS LTDVITACARE 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 STRIP1/7/2005
901NDA/MAL/HDP/2120ALKEM LABORATORIES LIMITEDABACUS PHARMA (AFRICA) LIMITEDMEGAPIMECEFEPIME1GALKEM LABORATORIES LTD.-VILLAGE THANA, BADDI, DISTT. SOLAN,HIMACHAL PRADESH 173205 INDIA. SANCE LABORATORIES PVT LTD-VI/51B, P.B. NO.2, KOZHUVANAL, PALA, KOTTAYAM DISTRICT-686573, KERALA, INDIA. INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0X1.0 G VIAL1/7/2011
902NDA/MAL/HDP/2125CIPLA LTD.CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDBECLATE 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 CANNISTER1/7/2009
903NDA/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 AMPOULE1/7/2005
904NDA/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 BLISTER1/7/2011
905NDA/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 CONTAINER1/7/2010
906NDA/MAL/HDP/2133NOVO NORDISKSTAR PHARMACEUTICALS LTDACTRAPIDHUMAN INSULIN100 I.U/MLNOVO NORDISK PHARMA-NOVO ALLE NOVO NORDISK PRODUCTION SAS-45 AVENUE D’ORLEANS, 28000 CHARTRES, FRANCE DENMARKPARENTERAL ORDINARY S C VIALS1.0X10.0 ML VIAL1/7/1997
907NDA/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 TUBE1/7/2005
908NDA/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 AMPOULE1/7/2014
909NDA/MAL/HDP/2149BAYER PHARMA AGSURGIPHARM (U) LIMITEDPRIMOLUT DEPOTHYDROXYPROGESTERONE HEXANOATE250MGBAYER PHARMA A.G-MULLERSTRASSE 178, 13353 BERLIN, GERMANY GERMANYPARENTERAL ORDINARY AMPOULES1.0X1.0 ML AMPOULE1/7/1997
910NDA/MAL/HDP/2150ELI-LILLY (SUISSE) SALABOREX UGANDA LIMITEDHUMULIN MIXTUREHUMAN INSULIN70/30 I.ULILLY EGYPT S.A.E. & ELI LILLY AND COMPANY LILLY TECHNOLOGY CENTRE INDIANAPOLIS,-INDIANA 46285 USA UNITED STATESPARENTERAL ORDINARY S C VIALS1.0X4.0 ML VIAL,1.0X10.0 ML VIAL,1.0X5.0X3.0 ML CARTRIDGE1/7/1997
911NDA/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 BLISTER1/7/2000
912NDA/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 BLISTER1/7/2000
913NDA/MAL/HDP/2158ACULIFE HEALTHCARE PVT LTDASTRA PHARMA (U) LIMITEDNIRPIDINTRAVENOUS FAT EMULSION20%W/VACULIFE HEALTHCARE PVT. LTD-VILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARAT INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X500.0 ML BOTTLE1/7/2010
914NDA/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 BLISTER1/7/2005
915NDA/MAL/HDP/2161REMEDICA LTDGOODMAN INTERNATIONAL LTDCYCLOVAX CREAMACICLOVIR5%W/WREMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR CYPRUSTOPICAL EXTERNAL CREAMS1.0X10.0 G TUBE1/7/1997
916NDA/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 BLISTER1/7/2014
917NDA/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 BLISTER1/7/2011
918NDA/MAL/HDP/2173GLENMARK PHARMACEUTICALS LTDSTAR PHARMACEUTICALS LTDGLEVO-500LEVOFLOXACIN500MGGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D INDIAORAL SOLID ORDINARY TABLETS1.0X5.0X5.0 TABLET BLISTER1/7/2003
919NDA/MAL/HDP/2175CIPLA LTD.CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDCIPLADONPARACETAMOL500MGCIPLA 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 STRIP1/7/2005
920NDA/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 BLISTER1/7/2011
921NDA/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 CONTAINER1/7/1997
922NDA/MAL/HDP/2185GLAXOSMITHKLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDROTARIXLIVE ATTENUATED RIX4414 STRAIN OF HUMAN ROTAVIRUS OF THE G1P[8] TYPENOT LESS THAN 10⁶ CCID₅₀ OF THE RIX4414 STRAINGLAXOSMITHKLINE AUSTRALIA.-GLAXOSMITHKLINE AUSTRALIA, 1061 MOUNTAIN HIGHWAY, BORONIA, VICTORIA, 3155 AUSTRALIA GLAXOSMITHKLINE BOILOGICALS-S.A RUE DE I'INSTITUT 89 B-1330 RIXENSART BELGIUMORAL LIQUID ORDINARY LIQUIDS1.0X1.5 ML TUBE (1 DOSE),1.0X50.0X1.5 ML TUBE (1 DOSE),1.0X7.5 ML TUBE (5-DOSE) FOR GAVI/UNICEF SUPPLY ONLY1/7/2009
923NDA/MAL/HDP/2186ABACUS PHARMA (A) LTD.ABACUS 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 BOTTLE1/7/2008
924NDA/MAL/HDP/2189ABACUS PHARMA (A) LTD.ABACUS 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 TUBE1/7/2008
925NDA/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 BLISTER1/7/1997
926NDA/MAL/HDP/2195XEPA SOUL PATTISON (M) SDN BHDDELMAW ENTERPRISES LIMITEDEUDERM CREAMUREA10%W/WXEPA-SOUL PATTINSON (MALAYSIA) SDN BHD-1-5 CHENG INDUSTRIAL ESTATE, 75250
MALEKA, MALAYSIA
MALAYSIATOPICAL EXTERNAL CREAMS1.0X45.0 G TUBE1/7/1997
927NDA/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 TUBE1/7/1997
928NDA/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 BLISTER1/7/2013
929NDA/MAL/HDP/2201SHAIGAN PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDCLYCINCLINDAMYCIN PHOSPHATE10MG/MLSHAIGAN PHARMACEUTICALS (PVT) LTD-14TH KM, ADYALA ROAD, RAWALPINDI-PAKISTAN PAKISTANTOPICAL EXTERNAL LOTIONS1.0X30.0 ML BOTTLE1/7/2008
930NDA/MAL/HDP/2208ABACUS PHARMA (A) LTD.ABACUS 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 BLISTER1/7/2010
931NDA/MAL/HDP/2211GALENTIC PHARMA (PVT)LTDVITACARE 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 BOTTLE1/7/2005
932NDA/MAL/HDP/2212DENK PHARMABENLE CONSULT LIMITEDCIPRO-DENK 500CIPROFLOXACIN500MGALLPHARMED PHARBIL ARZNEIMITTEL GMBH-12 D377081GERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER1/7/2005
933NDA/MAL/HDP/2214ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDGENTAMICIN INJECTIONGENTAMICIN SULPHATE40MG/MLREYOUNG PHARMACEUTICAL CO. LIMITED-NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA SCOTT-EDIL PHARMACIA LTD (UNIT I)-56, EPIP, PHASE-1, JHARMAJRI, BADDI, DISTT. SOLAN, (H.P), INDIA CHINAPARENTERAL ORDINARY AMPOULES1.0X100.0X2.0 ML AMPOULE1/7/2007
934NDA/MAL/HDP/2216GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDMETOCLOPRAMIDEMETOCLOPRAMIDE5MG/MLNINGBO DAHONGYING PHARMACEUTICAL CO.LTD-NO. 396 MINGZHU ROAD, HI-TECH PARK, NINGBO CITY ZHEJIANG PROVINCE, CHINA REYOUNG PHARMACEUTICAL CO. LIMITED-NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA CHINAPARENTERAL ORDINARY AMPOULES1.0X10.0X10.0X2.0 ML AMPOULE1/7/2005
935NDA/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 CONTAINER,1.0X2.0X15.0 TABLET BLISTER1/7/1997
936NDA/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 BLISTER1/7/2003
937NDA/MAL/HDP/2223ROYAL PHARMAROYAL PHARMA 2011 LIMITEDBENZATHINE PENICILLIN INJECTIONBENZATHINE PENICILLIN2400000 I.UCSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG)CO. LTD-NO. 88, YANGZI ROAD, SHIJIAZHUANG CITY, HEBEI PROVINCE(WORKSHOP 406 AND 407) CHINAPARENTERAL ORDINARY DRY VIALS1.0X2.4 MU VIAL1/7/2002
938NDA/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 SACHET1/7/2004
939NDA/MAL/HDP/2231MEDIPHARM SALES LIMITEDMEDIPHARM 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 BOTTLE1/7/1997
940NDA/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 BLISTER1/7/2011
941NDA/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 VIAL1/7/2011
942NDA/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 VIAL1/7/2006
943NDA/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 BLISTER1/7/1997
944NDA/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 VIAL1/7/2006
945NDA/MAL/HDP/2239NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDTEGRETOL SYRUPCARBAMAZEPINE20MG/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 BOTTLE1/7/2006
946NDA/MAL/HDP/2242REMEDICA LTDGOODMAN INTERNATIONAL LTDCYCLOVAX 200 TABLETSACYCLOVIR200MGREMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR CYPRUSORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER1/7/1997
947NDA/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 CONTAINER1/7/1997
948NDA/MAL/HDP/2245RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDX-PELMEBENDAZOLE100MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA UGANDAORAL SOLID ORDINARY CHEWABLE TABLETS1.0X1000.0 TABLET CONTAINER1/7/2008
949NDA/MAL/HDP/2248GALENTIC PHARMA (PVT)LTDVITACARE LIMITEDTETRACYCLINE OPHTHALMICTETRACYCLINE1%W/WGALENTIC PHARMA PVT. LIMITED-R-673, TTC MIDC, RUBALE, THANE, INDIA INDIAOPHTHALMIC OINTMENTS1.0X3.5 G TUBE,1.0X5.0 G TUBE1/7/2004
950NDA/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 VIAL1/7/2006
951NDA/MAL/HDP/2252JOHNSON&JOHNSON PTY LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDVERMOXMEBENDAZOLE500MGSPECPHARM HOLDINGS- 15TH ROAD HALFWAY HOUSE JOHNSON & JOHNSON (PTY) LTD-241 MAIN ROAD, RETREAT, 7945, CAPE TOWN SOUTH AFRICAORAL SOLID ORDINARY CHEWABLE TABLETS1.0X1.0 TABLET BLISTER1/7/2000
952NDA/MAL/HDP/2254MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDBURN CUR CREAMACRIFLAVINE/THYMOLN/ATORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506INDIATOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE1/7/1998
953NDA/MAL/HDP/2256GLAXOSMITH KLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDAUGMENTIN 457MG/5MLAMOXICILLIN + CLAVULANIC ACID400 MG + 57 MG / 5 MLGLAXO WELLCOME PRODUCTION-ZI DE LA PEYENNIERE, 53100, MAYENNE UNITED KINGDOMORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X1.0X70.0 ML BOTTLE1/7/2010
954NDA/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 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 BOTTLE1/7/2009
955NDA/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 BOTTLE1/7/2001
956NDA/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 BOTTLE1/7/2010
957NDA/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 BOTTLE1/7/2007
958NDA/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 BOTTLE1/7/1997
959NDA/MAL/HDP/2271IPCA LABORATORIES LTDMEDVIN 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 BLISTER1/7/2010
960NDA/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 BLISTER1/7/2005
961NDA/MAL/HDP/2280REMINGTON PHARMACEUTICAL INDUS. PVT LTD PAKISTANHEALTHCARE LTD.BETADROP-NBETAMETHASONE + NEOMYCIN0.1 %W/V + 0.5 %W/VREMINGTON PHARMACEUTICAL INDUS. PVT LTD-, 117 ALLAM PAKISTANOPHTHALMIC DROPS1.0X7.5 ML VIAL1/7/1999
962NDA/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 BLISTER1/7/2007
963NDA/MAL/HDP/2282GITTOES PHARMACEUTICALS LIMITEDGITTOES 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 CONTAINER1/7/2011
964NDA/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)1/7/1997
965NDA/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 CARTON1/7/1997
966NDA/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 BOTTLE1/7/2008
967NDA/MAL/HDP/2292MEDREICH PLCSURGIPHARM (U) LIMITEDFLEMING 1200AMOXICILLIN SODIUM + POTASSIUM CLAVULANATE1000MG + 200MGNATCO PHARMA LTD-VIJAYAPUR, NORTH NAGARIJUNA SAGA,INDIA INDIAPARENTERAL ORDINARY DRY VIALS1.0X5.0X20.0 ML VIAL1/7/2007
968NDA/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 TUBE1/7/2005
969NDA/MAL/HDP/2295DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDGAMA PHARMACEUTICALS (U) LIMITEDROZITTA 10ROSUVASTATIN CALCIUM10MGDAR AI DAWA-NA UR PLANT,AMMAN,JORDAN JORDANORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET STRIP1/7/2013
970NDA/MAL/HDP/2297DAWA LIMITEDSUPER MEDIC LTDSABULIN SYRUPSALBUTAMOL SULPHATE2MG/5MLDAWA LIMITED -BABA DOGO RWARAKAKENYAORAL LIQUID ORDINARY SYRUPS1.0X1.0X100.0 ML BOTTLE1/7/2008
971NDA/MAL/HDP/2298MSN LABORATORIES PRIVATE LIMITEDMETRO PHARMACEUTICALS LIMITEDSAFELEVO 500LEVOFLOXACIN500MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER1/7/2013
972NDA/MAL/HDP/2299DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDGAMA PHARMACEUTICALS (U) LIMITEDROZITTA 20ROSUVASTATIN CALCIUM20MGDAR AI DAWA-NA UR PLANT,AMMAN,JORDAN JORDANORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET STRIP1/7/2013
973NDA/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 BLISTER1/7/2014
974NDA/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 BLISTER1/7/2014
975NDA/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 BLISTER1/7/2014
976NDA/MAL/HDP/2306BAYER PHARMA AGSURGIPHARM (U) LIMITEDMICROLUTLEVONORGESTREL0.03MGBAYER PHARMA A.G-MULLERSTRASSE 178, 13353 BERLIN, GERMANY GERMANYORAL SOLID ORDINARY TABLETS1.0X3.0X35.0 TABLET BLISTER1/7/2010
977NDA/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 BLISTER1/7/2006
978NDA/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 BLISTER1/7/2006
979NDA/MAL/HDP/2314MACLEODS PHARMACEUTICALS LTDVITACARE 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 STRIP1/7/2005
980NDA/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 BOTTLE1/7/2006
981NDA/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 BLISTER1/7/2006
982NDA/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 BOTTLE1/7/1998
983NDA/MAL/HDP/2320GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDERO-125 DRY SYRUPERYTHROMYCIN ESTOLATE125MG/5MLAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE1/7/2006
984NDA/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 STRIP1/7/2007
985NDA/MAL/HDP/2324SWISS PARENTERALS LTDSHREEJI CARE 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 VIAL1/7/2011
986NDA/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 STRIP1/7/2004
987NDA/MAL/HDP/2330NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDCOARTEMARTEMETHER + LUMEFANTRINE20MG + 120MGNOVARTIS PHARMA AG-SCHAFFHAUSERSTRASSE 4332 STEIN SWITZERLAND 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 BLISTER,1.0X4.0X6.0 TABLET BLISTER1/7/2005
988NDA/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)1/7/1997
989NDA/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 DILUENT1/7/1997
990NDA/MAL/HDP/2338GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDCLAVULINAMOXICILLIN + CLAVULANIC ACID200 MG + 28.5 MGGLAXO WELLCOME PRODUCTION-ZI DE LA PEYENNIERE, 53100, MAYENNE FRANCEORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE,1.0X70.0 ML BOTTLE1/7/2003
991NDA/MAL/HDP/2339AUROBINDO PHARMA LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDKOACT-375AMOXICILLIN + CLAVULANATE POTASSIUM250 MG + 125 MGAUROBINDO PHARMA LTD, UNIT XII,.-SURVEY NO 314, BACHUPALLY VILLAGE, QUTHUBULLAPAR, R.R DISTRICT .A. PRADESH INDIAORAL SOLID ORDINARY TABLETS1.0X4.0X5.0 TABLET BLISTER,1.0X20.0X5.0 TABLET BLISTER1/7/2007
992NDA/MAL/HDP/2342AUROBINDO PHARMA LTD UNIT VIIPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDKOACT-625AMOXICILLIN + CLAVULANATE POTASSIUM500 MG + 125 MGAUROBINDO PHARMA LIMITED, UNIT III-SURVEY NO. 313 & 314, BACHUPALLY (MANDAL), MEDCHAL - MALKAJGIRI (DISTRICT) - 500090 TELENGANA (STATE) INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X5.0 TABLET BLISTER1/7/2007
993NDA/MAL/HDP/2348SERUM INSTITUTE OF INDIA LTD.NORVIK ENTERPRISES LIMITEDHEPATITIS B VACCINE(RDNA) ADULTHEPATITIS B VACCINE(RDNA) ADULT20MCG/MLSERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIA INDIAPARENTERAL ORDINARY I M VIALS1.0X10.0X10.0 ML VIAL (10 DOSE VIAL),1.0X50.0X1.0 ML VIAL (1 DOSE VIAL)1/7/2005
994NDA/MAL/HDP/2350ASTRA ZENECA ABMACNAUGHTON LIMITEDPULMICORT TURBUHALERBUDESONIDE200MCGASTRAZENECA AB,-GARTUNA & SNACKVIKEN STOCKHOLM SWEDENLUNG ADMINISTRATION METERED-DOSE INHALER1.0X100.0 DOSE CANNISTER1/7/2001
995NDA/MAL/HDP/2352REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDCOLDCAP DAY TIMEPARACETAMOL/PSEUDOEPHEDRINE HCL/CAFFEINE500MG+30MG+30MGREGAL PHARMACEUTICALS LIMITED -PLOT 7879/18 OF BABA DOGO ROAD, RUARAKA, NAIROBI KENYAORAL SOLID ORDINARY CAPSULES1.0X1.0X12.0 CAPSULE BLISTER1/7/2007
996NDA/MAL/HDP/2353ASTRA ZENECAMACNAUGHTON LIMITEDNEXIUMESOMEPRAZOLE (AS MAGNESIUM TRIHYDRATE)10MGASTRA ZENECA AB-SE-151 85 SODERTALJE, SWEDEN (GARTUNAVAGEN & SNACKVIKEN) SWEDENORAL SOLID ORDINARY GRANULES1.0X28.0 SACHET CARTON1/7/2013
997NDA/MAL/HDP/2354STRIDES SHASUN LIMITEDDELMAW ENTERPRISES LIMITEDLAMIVUDINE + ZIDOVUDINELAMIVUDINE + ZIDOVUDINE150MG + 300MGSTRIDES ARCOLAB LIMITED -36/7 SURAGAJAKKANAHALLI INDLAVADI CROSS ANEKAL TALUK BANGALORE 562 106INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X60.0 TABLET BOTTLE1/7/2006
998NDA/MAL/HDP/2357ACINO PHARMA AGGOODMAN INTERNATIONAL LTDTRABILIN- 50 CAPSULESTRAMADOL50MGMERCKLE GMBH,-LUDWIG MERCKLE STRASSE3 D-89143 BLAUBEUREN GERMANYORAL SOLID ORDINARY CAPSULES1.0X2.0X10.0 CAPSULE BLISTER1/7/2003
999NDA/MAL/HDP/2359REMEDICA LTDGOODMAN INTERNATIONAL LTDASPIREM 75ASPIRIN75MGREMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR CYPRUSORAL SOLID ORDINARY TABLETS1.0X2.0X28.0 TABLET BLISTER1/7/2007
1000NDA/MAL/HDP/2360ELYS CHEMICAL INDUSTRIES LTDVELVET PHARMA LIMITEDFUNGISTIN PESSARIESNYSTATIN100000 IUELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBI INDIAVAGINAL TABLETS1.0X14.0 PESSARY PACK,5.0X3.0 PESSARY STRIP,1.0X100.0 PESSARY CONTAINER1/7/2002
1001NDA/MAL/HDP/2361REMEDICA LTDGOODMAN INTERNATIONAL LTDCLAREM 500CLARITHROMYCIN500MGREMEDICA LTD-AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE, 3056 LIMASSOL CYPRUSORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X7.0 TABLET BLISTER1/7/2007
1002NDA/MAL/HDP/2362GALENTIC PHARMA LTDVITACARE LIMITEDCANDISTATIN OINTMENTNYSTATIN100,000I.UGALENTIC PHARMA PVT. LIMITED -R-673, TTC MIDC, RUBALE, THANE BELAPUR NAVI MUMBAI 400 701
INDIA
INDIATOPICAL EXTERNAL OINTMENTS1.0X30.0 G TUBE1/7/2009
1003NDA/MAL/HDP/2363GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDGENTAMICIN SULPHATEGENTAMICIN SULPHATE80MG/2MLNINGBO DAHONGYING PHARMACEUTICAL CO.LTD-NO. 396 MINGZHU ROAD, HI-TECH PARK, NINGBO CITY ZHEJIANG PROVINCE, CHINA REYOUNG PHARMACEUTICAL CO. LIMITED-NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA CHINAPARENTERAL ORDINARY AMPOULES1.0X10.0X2.0 ML AMPOULE,1.0X10.0X10.0X2.0 ML AMPOULE1/7/2005
1004NDA/MAL/HDP/2364AIVEEN (U) LIMITEDAIVEEN (U) LIMITEDVOXEL-500LEVOFLOXACIN500MGMEDICO REMEDIES PVT LIMITED-8 & 9 DEWAN & SONS, UDYOG NAGAR PALGAR, DISTRICT THANE MAHARASHTRA, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER1/7/2015
1005NDA/MAL/HDP/2366UNIQUE PHARMACEUTICALS LTDPLANET PHARMACEUTICALS UGANDA LTDIFICIPRO INJECTIONCIPROFLOXACIN200MG/100MLUNIQUE PHARMACEUTICALS LABS ( A DIV OF J.B CHEMICALS & PHARMACEUTICAL LTD)--304-308 ,GIDC , PANOLI 394116 INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X100.0 ML BOTTLE1/7/2005
1006NDA/MAL/HDP/2367REMEDICA LTDGOODMAN INTERNATIONAL LTDFELEXIN 125CEPHALEXIN MONOHYDRATE125MG/5MLREMEDICA LIMITED -AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUS CYPRUSORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE1/7/2007
1007NDA/MAL/HDP/2368REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDDERMIDEX CREAMMICONAZOLE NITRATE2%W/WREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA KENYATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE1/7/2007
1008NDA/MAL/HDP/2369ARISTO PHARMACEUTICALSNORVIK ENTERPRISES LIMITEDTRANLOK 500MG INJECTIONTRANEXAMIC ACID500MG/5MLARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO.II,MANDIDEEEP PRADESH INDIAPARENTERAL ORDINARY AMPOULES1.0X5.0X5.0 ML AMPOULE1/7/2010
1009NDA/MAL/HDP/2371PHARMA INTERNATIONAL COMPANYOMAB UGANDA LIMITEDTOPIZONE CREAMFUSIDIC ACID + BETAMETHASONE VALERATE20MG/G+1MG/GPHARMA INTERNATIONAL COMPANY-MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDAN JORDANTOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE1/7/2007
1010NDA/MAL/HDP/2375GLAXO SMITHLINE LIMITEDUNITED HEALTHCARE DISTRIBUTORS LTDCLAVULIN 1GAMOXICILLIN + CLAVULANIC ACID875 MG + 125 MGSMITHKLINE BEECHAM PHARMACEUTICALS,-CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QH UNITED KINGDOMORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X1.0X7.0 TABLET BLISTER1/7/2010
1011NDA/MAL/HDP/2379PT SANBE FARMAMEDVIN PHARMA LIMITEDPUMPITOROMEPRAZOLE40MGPT SANBE FARMA JI INDUSTRI-NO.8 KOMPLEKS INDUSTRI CIMAREME PADALARANG BANDUNGINDONESIAPARENTERAL ORDINARY VIALS1.0X1.0 VIAL CARTON + 1 AMPOULE OF SOLVENT1/7/2014
1012NDA/MAL/HDP/2381AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITEDROYAL PHARMA 2011 LIMITEDSIMTRIM-480 TABLETSCO-TRIMOXAZOLE480MGAFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED-PLOT 9-12,DEWAN & SONS INDL. AREA, VEOOR,PALGHAR-401404. INDIA.
INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER1/7/1997
1013NDA/MAL/HDP/2384PHARMA INTERNATIONAL COOMAB UGANDA LIMITEDCLARIX 500CLARITHROMYCIN500MGPHARMA INTERNATIONAL COMPANY-MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDAN JORDANORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X7.0 TABLET BLISTER1/7/2007
1014NDA/MAL/HDP/2385COSMOS LIMITEDASTRA PHARMA (U) LIMITEDCOZEPAM 5MGDIAZEPAM5MGCOSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA KENYAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER1/7/2000
1015NDA/MAL/HDP/2387DAWA LIMITEDSUPER MEDIC LTDVERMOUTMEBENDAZOLE100MG/5MLDAWA LIMITED -BABA DOGO RWARAKAKENYAORAL LIQUID ORDINARY SUSPENSIONS1.0X30.0 ML BOTTLE1/7/2010
1016NDA/MAL/HDP/2388DAFRA PHARMA LTDMULTIPHAR UGANDA LIMITEDDAFRACLAVAMOXYCILLIN + POTASSIUM CLAVULANATE400MG + 57MGBILIM ILAC SAN. VE. TIC. A.S.-CERKEZKOY ORGANIZE SANAYI BOLGESI, KARAAGAC, MH. 5. SK. NO. 6, KAPAKLI - TEKIRDAG 59510 TURKEYORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X70.0 ML BOTTLE1/7/2011
1017NDA/MAL/HDP/2390BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDP-ALAXINDIHYDROARTEMISININ/ PIPERAQUINE PHOSPHATE80MG /640MGBLISS GVS PHARMA LTD-PLOT.NO 10,SURVEY NO 38/1,DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR, TAL: PALGHAR DIST.THANE, MAHARASHTRA-INDIA INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X80.0 ML BOTTLE,1.0X120.0 ML BOTTLE1/7/2008
1018NDA/MAL/HDP/2394MERCK SHARP & DOHME BV.SURGIPHARM (U) LIMITEDSTOCRINEFAVIRENZ600MG ZHEJIANG HUAHAI PHARMACEUTICAL CO. LTD-XUNQIAO, LINHAI, ZHEJIANG PROVINCE 317024 PEOPLES’ REPUBLIC OF CHINA CHINAORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET BOTTLE1/7/2004
1019NDA/MAL/HDP/2395A.MENARINI INDUSTRIE FARMACEUTICHE S.R.ISTAR PHARMACEUTICALS LTDFASTUM GELKETOPROFEN2.5%W/WA. MENARINI MANUFACTURING LOGISTICS AND SERVICES S.R.L-VIA SETTE SANTI 3, 50131 FIRENZE-ITALY ITALYTOPICAL EXTERNAL GELS AND SOLS1.0X20.0 G TUBE,1.0X30.0 G TUBE,1.0X50.0 G TUBE,1.0X100.0 G TUBE1/7/2005
1020NDA/MAL/HDP/2399SUN PHARMACEUTICAL INDUSTRIES LIMITEDSTAR PHARMACEUTICALS LTDVOLINIMULTI INGREDIENTMULTI INGREDIENTSUN PHARMACEUTICAL IND. LTD-PLOT NO. B-2, MADKAI INDUSTRIAL ESTATE, PONDA- GOA, INDIA-403404 INDIATOPICAL EXTERNAL OTHER GELS/SOLS1.0X1.0X30.0 G TUBE1/7/2005
1021NDA/MAL/HDP/2400PHARMA INTERNATIONAL COMPANYOMAB UGANDA LIMITEDTOPIDIC 2%FUSIDIC ACID20MG/GPHARMA INTERNATIONAL COMPANY-MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDAN JORDANTOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE1/7/2007
1022NDA/MAL/HDP/2401MEGA LIFESCIENCES (AUSTRALIA) PTY LTDABACUS PHARMA (AFRICA) LIMITEDENATNATURAL VITAMIN E400IUMEGA LIFE SCIENCES PUBLIC COMPANY LIMITED-384 SOIB PATTANA 3 RD BANGPOO INDUSTRIAL ESTATE SAMUTPRAKARN 10280THAILANDORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER1/7/2005
1023NDA/MAL/HDP/2404UNICHEM LABORATORIES LIMITED√EUROPA HEALTHCARE (U) LTDLOSAR 50LOSARTAN POTASSIUM50MGUNICHEM LABORATORIES LTD---VILLAGE BHATAULI KALA, BADDI HIMACHAL PRADESH, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER1/7/2005
1024NDA/MAL/HDP/2408RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDRENIRON TONICMULTI-INGREDIENTMULTI-INGREDIENTRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA UGANDAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE,1.0X60.0 ML BOTTLE1/7/2001
1025NDA/MAL/HDP/2409TORRENT PHARMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.DEPLATTCLOPIDOGREL75MGTORRENT PHARMACEUTICALS LTD-INDRAD-382721, TAL KADI, AHMEDABAD, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER1/7/2004
1026NDA/MAL/HDP/2410RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDDOXYRENDOXYCYCLINE100MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA UGANDAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER1/7/2007
1027NDA/MAL/HDP/2411STEDMAN PHARMACEUTICALS PVT. LTDVEERAM HEALTHCARE (U) LIMITEDDREZPOVIDONE IODINE + METRONIDAZOLE5%W/W + 1%W/WSTEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA INDIATOPICAL EXTERNAL OINTMENTS1.0X30.0 G TUBE,1.0X10.0 G TUBE,1.0X100.0 G TUBE,1.0X250.0 G TUBE1/7/2010
1028NDA/MAL/HDP/2414SPARSH BIO-TECH PVT LTDABACUS PHARMA (AFRICA) LIMITEDSPAMCILAMPICILLIN125MG/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 BOTTLE1/7/1998
1029NDA/MAL/HDP/2415CENTAUR PHARMACEUTICALS LTDGITTOES PHARMACEUTICALS LIMITEDSOLINA TABLETSDIAZEPAM5MGCENTAUR PHARMACEUTICALS LTD-PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER1/7/1997
1030NDA/MAL/HDP/2426MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDPROBEX SYRUPMULTI-INGREDIENTMULTI-INGREDIENTTORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506INDIAORAL LIQUID ORDINARY SYRUPS1.0X225.0 ML BOTTLE,1.0X100.0 ML BOTTLE1/7/2000
1031NDA/MAL/HDP/2427SHOSAAN ASIC PACIFICRENE PHARMACY LTDCLONEMCLOTRIMAZOLE1%W/WNEM LABORATORIES PVT LTD-PLOT NO. 133 KRISHNA IND. ESTATE, VASAI E,DIST PALGHAR- 401210, MAHARASHTRA STATE INDIATOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE1/7/1997
1032NDA/MAL/HDP/2428DENK PHARMA GMBH & CO. KGBENLE CONSULT LIMITEDCLOTRI-DENK 1% CREAMCLOTRIMAZOLE1%W/WC.P.M. CONTRACTPHARMA GMBH & COMPANY KG-FRUHLINGSTR. 7, 83620 FELDKIRCHEN - WESTERHAM GERMANYTOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE1/7/1998
1033NDA/MAL/HDP/2429DENK PHARMA GMBH & CO. KGBENLE CONSULT LIMITEDCLOTRI-DENK 100 VAGINALCLOTRIMAZOLE100MGDENK PHARMA GMBH &CO.KG-PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANY ARTESAN PHARMA GMBH & CO. KG -WENDLANDSTRABE 1,29439 LUCHOW,GERMANY GERMANYVAGINAL TABLETS1.0X6.0 PESSARY CARTON1/7/1998
1034NDA/MAL/HDP/2431CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDFORMONIDE 200BUDESONIDE + FORMOTEROL FUMARATE200MCG/ 6MCGCADILA 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 CARTON1/7/2007
1035NDA/MAL/HDP/2432CADILA HEALTH CARE LTDABACUS PHARMA (AFRICA) LIMITEDFORMONIDE 100BUDESONIDE + FORMOTEROL FUMARATE100MCG+6MCGCADILA HEALTHCARE LTD---SARKHEJ-PLOT 417,419,420, SARKHEJ-BAVLA NH NO.8A,VILLAGE: MORAIYA TAL: SANAND DISTRICT AHMEDABAD 382210 INDIALUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER1.0X120.0 METERED DOSE CANNISTER1/7/2007
1036NDA/MAL/HDP/2434STRIDES SHASUN LIMITEDDELMAW ENTERPRISES LIMITEDSOLCEROMEPRAZOLE40MGREYOUNG PHARMACEUTICAL CO. LIMITED-NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA CHINAPARENTERAL ORDINARY DRY VIALS1.0X10.0 ML VIAL1/7/2009
1037NDA/MAL/HDP/2438INTAS, PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDHIFENACACECLOFENAC100MGINTAS PHARMACEUTICALS LTD-CAMP ROAD SELAQUI DEHRADUNINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER1/7/2006
1038NDA/MAL/HDP/2451ACINO PHARMA AGGOODMAN INTERNATIONAL LTDOLFEN -75 SR PROLONGED - BRELEASE TABLETSDICLOFENAC SODIUM75 MGACINO PHARMA AG-DORNACHERSTRASSE 114, CH-4147 AESCH SWITZERLANDORAL SOLID RETARD TABLETS1.0X3.0X10.0 TABLET BLISTER1/7/2004
1039NDA/MAL/HDP/2452REGAL PHARMA U LIMITEDREGAL PHARMA (U) LTDDELASED CHEST COUGH SYRUP (NON DROWSY)GUAIFENESIN + MENTHOL100MG/5ML + 1.1MG/5MLREGAL PHARMACEUTICALS-PLOT 7879/18 BABA DOGO ROAD NAIROBIKENYAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE1/7/2007
1040NDA/MAL/HDP/2458XEPA SOUL PATTISON (M) SDN BHDDELMAW ENTERPRISES LIMITEDPRISTINEX 2% CREAMKETOCONAZOLE2%W/WXEPA-SOUL PATTINSON (MALAYSIA) SDA BHD-1-5, CHENG INDUSTRIAL ESTATE, 75250, MELAKA, MALAYSIA MALAYSIATOPICAL EXTERNAL CREAMS2.0X15.0 G TUBE1/7/2006
1041NDA/MAL/HDP/2460COSMOS LTDASTRA PHARMA (U) LIMITEDBENZHEXOL TABLETS 2MGBENZHEXOL HCL2MGCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI KENYAORAL SOLID ORDINARY TABLETS1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER1/7/2000
1042NDA/MAL/HDP/2462REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDHISTALIN SYRUPCHLORPHENIRAMINE MALEATE/PROMETHAZINE/DIPHENHYDRAMINE/EPHEDRINE/AMMONIUM CHLORIDE/SODIUM CITRATE1.0MG+ 2.5MG+5.0MG+7.5MG+90.0MG+48.0MG/ 5ML.REGAL PHARMACEUTICALS LTD..-PLOT 7879/18 OFF BABA DOGO ROAD, RUARAKA KENYAORAL LIQUID ORDINARY SYRUPS1.0X60.0 ML BOTTLE,1.0X5.0 L JERRYCAN1/7/1997
1043NDA/MAL/HDP/2467CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDNOKLOTCLOPIDOGREL75MGCADILA HEALTHCARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO.203-213, KUNDAIM GOA, 403115, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER1/7/2003
1044NDA/MAL/HDP/2472SHOSAAN ASIC PACIFICRENE PHARMACY LTDTRAN-GELDICLOFENAC DIETHYLAMMONIUM1%W/WNEM LABORATORIES PVT LTD-PLOT NO. 133 KRISHNA IND. ESTATE, VASAI E,DIST PALGHAR- 401210, MAHARASHTRA STATE INDIATOPICAL EXTERNAL GELS AND SOLS1.0X30.0 G TUBE,1.0X20.0 G TUBE1/7/2011
1045NDA/MAL/HDP/2473MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDNUGRELCLOPIDOGREL75MGMICRO LABS LTD 92 SIPCOT -92 SIPCOT HOSUR 635 126 TAMIL NADUINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER1/7/2010
1046NDA/MAL/HDP/2475WIN-MEDICURE LTDSURGIPHARM (U) LIMITEDURGENDOL INJECTIONTRAMADOL HYDROCHLORIDE50MG/MLWIN- MEDICARE LTD-MODIPURAM -250 110,UTTAR PRAADESH, INDIA. INDIAPARENTERAL ORDINARY AMPOULES1.0X1.0 ML AMPOULE,1.0X2.0 ML AMPOULE1/7/2001
1047NDA/MAL/HDP/2476GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDDERIVA AQUEOUS GELADAPALENE0.1%W/WGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D INDIATOPICAL EXTERNAL GELS AND SOLS1.0X15.0 G TUBE1/7/2003
1048NDA/MAL/HDP/2478WIN-MEDICARE PVT LTDSURGIPHARM (U) LIMITEDDICLOMOL PLUSPARACETAMOL+DICLOFENAC500MG+50MGWIN MEDICARE PVT LIMITED-MEERUT, MUZAFFARNAGER ROAD, MODIPURAM – 250110, UTTAR PRADESH -INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER1/7/2005
1049NDA/MAL/HDP/2479SANCE LABORATORIES PVT LTDDELMAW ENTERPRISES LIMITEDSANCEPH-250 CAPCEPHALEXIN250MGSANCE LABORATORIES PVT. LTD.-VI/B, P.B. NO. 2, KOZHUVANAL, PALA, KOTTAYAM DISTRICT-686573, KERALA,
INDIA.
INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER1/7/2012
1050NDA/MAL/HDP/2481GALENTIC PHARMA (PVT)LTDVITACARE LIMITEDNETRACORTHYDROCORTISONE1%W/WGALENTIC PHARMA PVT LIMITED-R-673,MIDC TTC RABALE THANE-BELAPUR ROAD,NAVI MUMBAI INDIATOPICAL EXTERNAL OINTMENTS1.0X15.0 G TUBE,1.0X20.0 G TUBE1/7/2005
1051NDA/MAL/HDP/2497CIPLA LTD.CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDNEVIMUNENEVIRAPINE50MG/5MLCIPLA LTD --PLOT NO 9, 10 & 15, PHARMA ZONE, PHASE II,
SECTOR III, INDORE SPECIAL ECONOMIC ZONE, PITHAMPUR, DIST: DHAR, MADHYA PRADESH – 454 775, INDIA
INDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE1/7/2004
1052NDA/MAL/HDP/2500MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDCHLORAMPHENICOL SODIUM SUCCINATE INJECTION BPCHLORAMPHENICOL SODIUM SUCCINATE1GMACLEODS PHARMACEUTICALS LTD -PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT), INDIA. INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0 G VIAL1/7/2007
1053NDA/MAL/HDP/2502ROYAL GROUPABACUS PHARMA (AFRICA) LIMITEDPROBETA N EYE DROPBETAMETHASONE + NEOMYCIN0.1%W/V+0.5%W/VATCO LABORATORIES PVT LTD-B-18,S.I.T.E KARACHI 75700, PAKISTAN PAKISTANOPHTHALMIC DROPS1.0X7.5 ML VIAL1/7/1997
1054NDA/MAL/HDP/2504LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDRESTOCINPARACETAMOL + CHLORPHENIRAMINE MALEATE + CAFFEINE + PHENYLEPHRINE HCL500MG+ 2MG+ 2MG + 30MGLINCOLN PHARMACEUTICALS LIMITED-10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
INDIAORAL SOLID ORDINARY TABLETS1.0X50.0X1.0X4.0 TABLET STRIP1/7/2008
1055NDA/MAL/HDP/2506WOCKHARDT LTDSTAR PHARMACEUTICALS LTDNADOXINNADIFLOXACIN1%W/WWOCKHARDT LTD -VILLAGE KUNJHAL P.O BAROTIWALA DIST SOLAN HIMACHAL PRADESHINDIATOPICAL EXTERNAL CREAMS1.0X10.0 G TUBE,1.0X20.0 G TUBE1/7/2011
1056NDA/MAL/HDP/2507CIPLA LTDCIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDEXERMET 1000METFORMIN HCL1000MGCIPLA LIMITED ,.,.-VILLAGE UPPER MALPUR, P.O. BHUD, THE. NALAGARH DISTRICT SOLAN HIMACHAL PRADESH PIN 173205 CIPLA LTD ----D-7 MIDC INDUSTRIAL AREA, KURKUMBH, TAL INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER1/7/2007
1057NDA/MAL/HDP/2509BETA HEALTHCARE UGANDA LIMITEDBETA HEALTHCARE UGANDA LIMITEDOPELE LOTIONBENZYL BENZOATE25%W/VBETA HEALTHCARE INTERNATIONAL LTD - -PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYA KENYATOPICAL EXTERNAL LOTIONS1.0X50.0 ML BOTTLE1/7/1997
1058NDA/MAL/HDP/2510PANACEA BIOTEC PHARMA LTDVITACARE LIMITEDGIROORDNIDAZOLE500MGPANACEA BIOTEC PHARMA LIMITED-MALPURI BADDI, DISTRICT SOLAN, HIMACHAL PRADESH-173205 - INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X5.0X2.0X10.0 TABLET BLISTER1/7/2013
1059NDA/MAL/HDP/2512ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDDICLOFENAC SODIUM INJECTABLE SOLUTIONDICLOFENAC SODIUM25MG/MLWUHAN FUXING BIOPHARMACEUTICAL CO., LTD-NO.9, FUXING ROAD, HANCUAN ECONOMIC & DEVELOPMENT DISTRICT, HUBEI PROVINCE CHINAPARENTERAL ORDINARY AMPOULES1.0X10.0X10.0X3.0 ML AMPOULE,1.0X10.0X3.0 ML AMPOULE1/7/2009
1060NDA/MAL/HDP/2513REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDUNIPEN DRY SYRUPPHENOXYMETHYLPENICILLIN125MG/5MLREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA KENYAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE1/7/1997
1061NDA/MAL/HDP/2515AFRICURE PHARMACEUTICALS (INDIA) LTDROYAL PHARMA 2011 LIMITEDSIMFEN 200 TABLETSIBUPROFEN200MGAFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED-PLOT 9-12,DEWAN & SONS INDL. AREA, VEOOR,PALGHAR-401404. INDIA.
INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER1/7/1997
1062NDA/MAL/HDP/2523SHOSAAN ASIC PACIFICRENE PHARMACY LTDSULPHUR OINTMENTSULPHUR10%W/WNEM LABORATORIES PVT LTD---133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAIINDIATOPICAL EXTERNAL OINTMENTS1.0X25.0 G TUBE1/7/1997
1063NDA/MAL/HDP/2525DENK PHARMA GMBH & CO. KGBENLE CONSULT LIMITEDDICLO-DENK 100 RETARDDICLOFENAC SODIUM100MGDENK PHARMA GMBH &CO.KG--PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANY GERMANYORAL SOLID RETARD TABLETS10.0X10.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER1/7/1998
1064NDA/MAL/HDP/2526REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDUNISTEN COMBI PACKCLOTRIMAZOLE500MG & 1 %W/WREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA KENYAVAGINAL COMBINATION PACK TABLETS1.0X1.0 PESSARY BLISTER + 1*20G TUBE1/7/2009
1065NDA/MAL/HDP/2528LABORATORY AND ALLIED LTDHARLEYS UGANDA LIMITEDLABESTENCLOTRIMAZOLE1%W/WLABORATORY & ALLIED LTD.---PLOT 209/10349 OFF MOMBASA RD NAIROBIKENYATOPICAL EXTERNAL CREAMS1.0X1.0X15.0 G TUBE,1.0X1.0X20.0 G TUBE1/7/1997
1066NDA/MAL/HDP/2529B & O PHARM ZACTRIDEM PHARMA UGANDA LIMITEDG-CEFTRIACEFTRIAXONE1GGUILIN PHARMACEUTICAL CO LTD-NO.43 QILIDIAN ROAD GUILIN 541004 GUANGXI CHINA NATIONAL MEDICINES, GUORUI PHARMACEUTICAL CO., LTD-CAOYANG EAST ROAD, HUAINAN ECONOMICAL AND TECHNOLOGICAL DEVELOPMENT ZONE, HUAINAN CITY ANHUI PROVINCE CHINAPARENTERAL ORDINARY DRY VIALS1.0X1.0 G VIAL + 10 ML AMPOULE WFI,1.0X1.0X50.0 G VIAL,1.0X1.0 VIAL CARTON1/7/2012
1067NDA/MAL/HDP/2545NORVATIS PHARMA AG- SWITZERLANDLABOREX UGANDA LIMITEDTOBREXTOBRAMYCIN0.3%W/VALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUM BELGIUMOPHTHALMIC DROPS1.0X5.0 ML BOTTLE1/7/1997
1068NDA/MAL/HDP/2552AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDCAROFITVITAMIN C/ VITAMIN A/ ZINC SULPHATE150MG/10MG/75MGAJANTA PHARMA LIMITED-B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER1/7/2005
1069NDA/MAL/HDP/2553GLENMARK PHARMACEUTICAL LTD.STAR PHARMACEUTICALS LTDESOZ-20ESOMEPRAZOLE20MGGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET STRIP,1.0X10.0 TABLET STRIP1/7/2003
1070NDA/MAL/HDP/2554GLENMARK PHARMACEUTICAL LTD.STAR PHARMACEUTICALS LTDESOZESOMEPRAZOLE40MGGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D INDIAORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET STRIP,1.0X10.0X10.0 TABLET STRIP1/7/2005
1071NDA/MAL/HDP/2555COSMOS LTDASTRA PHARMA (U) LIMITEDPHENOBARBITONE TABLETS BP 30MGPHENOBARBITONE30MGCOSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA KENYAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER1/7/1998
1072NDA/MAL/HDP/2557REMEDICA LTDGOODMAN INTERNATIONAL LTDEPSITRON 25 TABLETSCAPTOPRIL25MGREMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR CYPRUSORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER1/7/1999
1073NDA/MAL/HDP/2558RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDMYCOREN SUSPENSIONNYSTATIN100000 I.U/ML RENE INDUSTRIES LTD-680,KAMULI,KIREKA
KAMPALA,UGANDA
UGANDAORAL TOPICAL SUSPENSIONS1.0X30.0 ML BOTTLE1/7/2007
1074NDA/MAL/HDP/2559RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDERYTHRORENERYTHROMYCIN STEARATE250MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA UGANDAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER1/7/2007
1075NDA/MAL/HDP/2562ACINO PHARMA AGGOODMAN INTERNATIONAL LTDTRABILIN-100TRAMADOL100MG/2MLMERCKLE GMBH,-LUDWIG MERCKLE STRASSE3 D-89143 BLAUBEUREN GERMANYPARENTERAL ORDINARY AMPOULES1.0X1.0X5.0X2.0 ML AMPOULE1/7/2005
1076NDA/MAL/HDP/2565CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDTRAMAZAC INJECTIONTRAMADOL HYDROCHLORIDE50MG/MLCADILA HEALTHCARE LTD---SARKHEJ-PLOT 417,419,420, SARKHEJ-BAVLA NH NO.8A,VILLAGE: MORAIYA TAL: SANAND DISTRICT AHMEDABAD 382210 INDIAPARENTERAL ORDINARY AMPOULES1.0X2.0 ML AMPOULE,1.0X5.0X2.0 ML AMPOULE1/7/2001
1077NDA/MAL/HDP/2567CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDCIPROBID-500CIPROFLOXACIN500MGCADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA S.KANT HEALTHCARE LIMITED--PLOT NO. 1802-1805,GIDC PHASE II-396195,DIST.VALSAD,GUJARAT,INDIA PINNACLE LIFE SCIENCE PVT LTD-KHASRA NO. 1328 - 1330, VILLAGE MANPURA, TEHSIL BADDI, DIST. SOLAN, HIMACHAL PRADESH - 174101 INDIAORAL SOLID ORDINARY FILM-COATED TABLETS10.0X10.0 TABLET BLISTER1/7/1997
1078NDA/MAL/HDP/2568GLAXO WELLCOME (KENYA) LTDUNITED HEALTHCARE DISTRIBUTORS LTDZINNATCEFUROXIME AXETIL500MGGLAXOSMITHKLINE UK LTD-HARMIRE RD BARNARD CASTLE DURHAM, DL12DT UNITED UNITED KINGDOMORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER,1.0X50.0 TABLET CARTON1/7/1997
1079NDA/MAL/HDP/2570REMEDICA LTDGOODMAN INTERNATIONAL LTDAMOXAPEN 250 CAPSULESAMOXYCILLIN250MGREMEDICA LIMITED -AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUS CYPRUSORAL SOLID ORDINARY CAPSULES10.0X10.0 CAPSULE BLISTER,100.0X10.0 CAPSULE BLISTER1/7/1997
1080NDA/MAL/HDP/2576RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDRENEQUINE TABLETSCHLOROQUINE PHOSPHATE250MG RENE INDUSTRIES LTD-680,KAMULI,KIREKA
KAMPALA,UGANDA
UGANDAORAL SOLID ORDINARY TABLETS1.0X250.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER1/7/2000
1081NDA/MAL/HDP/2578REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDMAGNOMINT TABLETSALUMINIUM HYDROXIDE + MAGNESIUM TRISILICATE125MG + 250MGREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA KENYAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER,1.0X50.0X2.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER1/7/1997
1082NDA/MAL/HDP/2580ABACUS PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDHEDON TABLETSPARACETAMOL + ASPIRIN + CAFFEINE250 MG+ 300 MG + 30 MGREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA LINCOLN PHARMACEUTICALS LTD--TRIMUL ESTATE AFER VODSAR VILLAGE KHATJAT 382 721 GUJARAT VADSAR P.O.J TALUKA KALOH DIST GANDHINAGAR INDIA MILAN LABORATORIES (INDIA) PVT LTD - -63,67,87,35,36, 64, 65 JAWAHAR CO-OP INDUSTRIAL ESTATE KAMOTHE, PANVEL NAVI MUMBAI KESAR PHARMA PVT LTD-PLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARAT KENYAORAL SOLID ORDINARY TABLETS1.0X50.0X2.0 TABLET STRIP1/7/1998
1083NDA/MAL/HDP/2593DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDATENOLOL DENK 50ATENOLOL50MGARTESAN PHARMA GMBH & CO. KG -WENDLANDSTRABE 1,29439 LUCHOW,GERMANY GERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER1/7/2005
1084NDA/MAL/HDP/2594GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDFEFFERROUS SULPHATE + FOLIC ACID200MG + 0.4MGAGOG 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 BLISTER1/7/2009
1085NDA/MAL/HDP/2595MEDOCHEMIE LTDLABOREX UGANDA LIMITEDZEPILENCEFAZOLIN1000MGMEDOCHEMIE (FACTORY C)-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA, 4101 AGIOS ATHANASSIOS, LIMASSOL CYPRUSPARENTERAL ORDINARY DRY VIALS1.0X10.0 VIAL CARTON1/7/2009
1086NDA/MAL/HDP/2597E DENK OHGBENLE CONSULT LIMITEDPARA DENK 250PARACETAMOL250MGRUBIEPHARM ARZNEIMITTEL GMHH -GERMANY BENE-ARZNEIMITTEL GMBH-HERTERICHSTR. 1,81479 MUENCHEN, GERMANY GERMANYRECTAL SYSTEMIC SUPPOSITORIES1.0X5.0 SUPPOSITORY STRIP,1.0X2.0X5.0 SUPPOSITORY STRIP1/7/2005
1087NDA/MAL/HDP/2600IND SWIFT LTDPLANET PHARMACEUTICALS UGANDA LTDCLARIE-ODCLARITHROMYCIN(EXTENTED RELEASE)500MGIND-SWIFT-LTD,-GLOBAL BUSINESS UNIT, JAWAHARPUR, OFF NH-21 DERABASSI INDIAORAL SOLID RETARD FILM-COATED TABLETS1.0X10.0X1.0X7.0 TABLET BLISTER1/7/2008
1088NDA/MAL/HDP/2601MEDOCHEMIE LTDLABOREX UGANDA LIMITEDAXETINE 750MGCEFUROXIME750MGMEDOCHEMIE (FACTORY C)-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA, 4101 AGIOS ATHANASSIOS, LIMASSOL CYPRUSPARENTERAL ORDINARY DRY VIALS1.0X10.0 VIAL CARTON1/7/2009
1089NDA/MAL/HDP/2602: ALKEM LABORATORIES LIMITED√ABACUS PHARMA (AFRICA) LIMITEDCLAVAM BIDAMOXICILLIN + CLAVULANIC ACID200 MG + 28.5 MG/ 5 MLINDCHEMIE HEALTH SPECIALITIES PVT. LTD-VILLAGE-THANA, BADDI, DIST. SOLAN, HIMACHAL PRADESH-173 205. INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE1/7/2010
1090NDA/MAL/HDP/2603CIPLA LTD.CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDVIRADAYTENOFOVIR + EMTRICITABINE + EFAVIRENZ300 MG + 200 MG + 600 MGCIPLA 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 BOTTLE1/7/2011
1091NDA/MAL/HDP/2604USV PRIVATE LIMITEDABACUS PHARMA (AFRICA) LIMITEDGROVIT SYRUPMULTI-INGREDIENTMULTI-INGREDIENTSAKAR HEALTHCARE PVT LTD-SAKAR HEALTHCARE PVT LTD, BLOCK NO 10-13, M.N. DESA INDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE1/7/2000
1092NDA/MAL/HDP/2610GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDATROPINEATROPINE1MG/MLNINGBO DAHONGYING PHARMACEUTICALS LTD- NO. 396 MINCHINAPARENTERAL ORDINARY AMPOULES1.0X10.0X1.0 ML AMPOULE1/7/2009
1093NDA/MAL/HDP/2612RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDRENIRONMULTI-INGREDIENTMULTI-INGREDIENTRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA UGANDAORAL SOLID ORDINARY CAPSULES3.0X10.0 CAPSULE BLISTER1/7/2005
1094NDA/MAL/HDP/2615ASTRA ZENECA ABMACNAUGHTON LIMITEDSYMBICORT TURBUHALERBUDESONIDE+FORMOTEROL160MCG+4.5MCG/DOSEASTRAZENECA AB,-GARTUNA & SNACKVIKEN STOCKHOLM SWEDENLUNG ADMINISTRATION METERED-DOSE POWDER INHALER1.0X60.0 DOSE CANNISTER,1.0X120.0 DOSE CANNISTER1/7/2001
1095NDA/MAL/HDP/2628MICRO LABS LTDLABOREX UGANDA LIMITEDAZILIDE-500AZITHROMYCIN500MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X3.0 TABLET BLISTER1/7/2004
1096NDA/MAL/HDP/2641MEDOCHEMIE LTDLABOREX UGANDA LIMITEDAXETINE 250MGCEFUROXIME AXETIL250MGMEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY,FACTORY C-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIALAREA 4101 AGIOS ATHANASSIOUS LIMASSOL CYPRUS CYPRUSORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET STRIP1/7/2014
1097NDA/MAL/HDP/2642MEDOCHEMIE LTDLABOREX UGANDA LIMITEDMEDOXANUMCEFTRIAXONE1GMEDOCHEMIE (FACTORY C)-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA, 4101 AGIOS ATHANASSIOS, LIMASSOL CYPRUSPARENTERAL ORDINARY DRY VIALS1.0X1.0 G VIAL + 10 ML AMPOULE WFI1/7/2009
1098NDA/MAL/HDP/2645SANCE LABORATORIES PVT LTDDELMAW ENTERPRISES LIMITEDSANZIDIME 1000CEFTAZIDIME1000MGSANCE LABORATORIES PVT. LTD.-VI/B, P.B. NO. 2, KOZHUVANAL, PALA, KOTTAYAM DISTRICT-686573, KERALA,
INDIA.
INDIAPARENTERAL ORDINARY DRY VIALS1.0X20.0 ML VIAL1/7/2010
1099NDA/MAL/HDP/2647DENK PHARMA GMBH & CO KGBENLE CONSULT LIMITEDIBUPROFEN DENK 400MGIBUPROFEN400MGDENK PHARMA GMBH &CO.KG--PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANY GERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X10.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER1/7/2005
1100NDA/MAL/HDP/2648E DENK OHGBENLE CONSULT LIMITEDPARA DENK 125PARACETAMOL125MGRUBIEPHARM ARZNEIMITTEL GMHH -GERMANY BENE-ARZNEIMITTEL GMBH-HERTERICHSTR. 1,81479 MUENCHEN, GERMANY GERMANYRECTAL SYSTEMIC SUPPOSITORIES1.0X5.0 SUPPOSITORY STRIP,1.0X2.0X5.0 SUPPOSITORY STRIP1/7/2005
1101NDA/MAL/HDP/2650DENK PHARMABENLE CONSULT LIMITEDVIT-B-DENKTHIAMINE HCL + PYRIDOXINE HCL100MG + 200MGDENK PHARMA GMBH & CO.-PRINZREGENTENSTR. 79, 81675 MÜNCHEN, GÖLLSTR. 1, 84529 TITTMONING, GERMANY GERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET CARTON,1.0X10.0X10.0 TABLET BLISTER1/7/2005
1102NDA/MAL/HDP/2651REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDRINAVIT SYRUPMULTIVITAMINMULTI-INGREDIENTREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA KENYAORAL LIQUID ORDINARY SYRUPS1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE1/7/1997
1103NDA/MAL/HDP/2653BLUE CROSS LABORATORIES LTDSTAR PHARMACEUTICALS LTDSONADERM-GMCLOBETASOL + MICONAZOLE + GENTAMICIN0.05%W/W + 2% W/W+ 0.1%W/WBLUE CROSS LABORATORIES LTD-L-17, VERNA INDUSTRIAL ESTATE,VERNA GOA-403722 INDIATOPICAL EXTERNAL CREAMS1.0X10.0 G TUBE1/7/2007
1104NDA/MAL/HDP/2656ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDAMINOPHYLLINEAMINOPHYLLINE100MGSCOTT-EDIL PHARMACIA LTD (UNIT I)-56, EPIP, PHASE-1, JHARMAJRI, BADDI, DISTT. SOLAN, (H.P), INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X500.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER1/7/2008
1105NDA/MAL/HDP/2671CIPLA LTD..CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDDUOLIN RESPULESIPRATROPIUM BROMIDE & SALBUTAMOL500MG + 2.5 MG /2.5MLCIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA INDIALUNG ADMINISTRATION LIQUID FOR INHALATION4.0X5.0X2.5 ML VIAL1/7/2005
1106NDA/MAL/HDP/2675LEBEN LABORATORIES PVT LTDMALIX PHARMA (U) LIMITEDLIBITUS PLUS SYRUPTERBUTALINE/ BROMHEXINE/ GUAIPHENESIN1.25MG/ 4MG/ 50 MGLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE1/7/2011
1107NDA/MAL/HDP/2678CIPLA LTD.CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDFORCAN-150FLUCONAZOLE150MGCIPLA LTD -PLOT NO. L-139, VERNA, GOA 403 722 INDIA INDIAORAL SOLID ORDINARY CAPSULES1.0X5.0 CAPSULE BLISTER1/7/2006
1108NDA/MAL/HDP/2679CIPLA LTD.CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDALERID SYRUPCETIRIZINE HYDROCHLORIDE5MG/5ML CIPLA LIMITED-PLOT NO 9 & 10, PHARMA ZONE, PHASE II, INDORE SPECIAL
ECONOMIC ZONE, PITHAMPUR, DIST: DHAR, MADHYA PRADESH – 454 775, INDIA.
INDIAORAL LIQUID ORDINARY SYRUPS1.0X30.0 ML BOTTLE1/7/2006
1109NDA/MAL/HDP/2680RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDAMPIREN CAPSULESAMPICILLIN TRIHYDRATE250MG RENE INDUSTRIES LTD-680,KAMULI,KIREKA
KAMPALA,UGANDA
UGANDAORAL SOLID ORDINARY CAPSULES1.0X1000.0 CAPSULE CONTAINER1/7/2007
1110NDA/MAL/HDP/2681RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDAMOXIRENAMOXICILLIN TRIHYDRATE250MG RENE INDUSTRIES LTD-680,KAMULI,KIREKA
KAMPALA,UGANDA
UGANDAORAL SOLID ORDINARY CAPSULES1.0X1000.0 CAPSULE CONTAINER1/7/2007
1111NDA/MAL/HDP/2683RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDVITAMIN CASCORBIC ACID100MG RENE INDUSTRIES LTD-680,KAMULI,KIREKA
KAMPALA,UGANDA
UGANDAORAL SOLID ORDINARY CHEWABLE TABLETS1.0X1000.0 TABLET CONTAINER1/7/2005
1112NDA/MAL/HDP/2685RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDRENEDOL(SUSPENSION)PARACETAMOL120MG/5ML RENE INDUSTRIES LTD-680,KAMULI,KIREKA
KAMPALA,UGANDA
UGANDAORAL LIQUID ORDINARY SUSPENSIONS1.0X1.0X100.0 ML BOTTLE,1.0X1.0X60.0 ML BOTTLE1/7/2007
1113NDA/MAL/HDP/2690ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDAMPIMAX-250AMPICILLIN250MGREYOUNG PHARMACEUTICAL CO. LIMITED-NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA CHINAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER1/7/2011
1114NDA/MAL/HDP/2691ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDAMPIMAX-500AMPICILLIN500MGINJECT CARE PARENTERALS PVT LTD-PLOT NO. 130 SILVASSA ROAD, GIDC VAPI 396195 REYOUNG PHARMACEUTICAL CO. LIMITED-NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA CHINAPARENTERAL ORDINARY DRY VIALS1.0X50.0X500.0 MG VIAL,1.0X100.0 VIAL CARTON1/7/2011
1115NDA/MAL/HDP/2696BHARAT SERUMS AND VACCINES LTDABACUS PHARMA (AFRICA) LIMITEDAMPHOTRETAMPHOTERICIN B50MGBHARAT SERUMS AND VACCINES LTD- PLOT NO. K-27 ADDITIONAL MIDC AMBERNATH (E ) 412 501INDIAPARENTERAL ORDINARY VIALS1.0X1.0 VIAL CARTON1/7/2012
1116NDA/MAL/HDP/2697REGAL PHARMA U LIMITEDREGAL PHARMA (U) LTDLUCIN OINTMENTHYDROCORTISONE1%W/WREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA KENYATOPICAL EXTERNAL OINTMENTS1.0X15.0 G TUBE1/7/1997
1117NDA/MAL/HDP/2698CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDAZICIN-500AZITHROMYCIN500MGPINNACLE LIFE SCIENCE PVT LTD-KHASRA NO. 1328 - 1330, VILLAGE MANPURA, TEHSIL BADDI, DIST. SOLAN, HIMACHAL PRADESH - 174101 INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X3.0 TABLET BLISTER1/7/2009
1118NDA/MAL/HDP/2699CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDCARVIL 12.5CARVEDILOL12.5 MGCADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER1/7/2005
1119NDA/MAL/HDP/2702CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDEUGLIM 2GLIMEPIRIDE2MGCADILA HEALTH CARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET STRIP1/7/2004
1120NDA/MAL/HDP/2703AUROBINDO PHARMA LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDKOACT 312.50CO-AMOXICLAV (AMOXYCILLIN TRIHYDRATE+POTASSIUM CLAVUNATE)250+62.50MG/ 5MLAUROBINDO PHARMA LTD, UNIT XII,.-SURVEY NO 314, BACHUPALLY VILLAGE, QUTHUBULLAPAR, R.R DISTRICT .A. PRADESH INDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE1/7/2007
1121NDA/MAL/HDP/2705ASTRAZENECAMACNAUGHTON LIMITEDPULMICORT NEBULISERBUDESONIDE0.5MG/MLASTRA ZENECA SWEDEN OPERATIONS LIQUID PRODUCTION -KVARNBERGAGATANLZ SE-151-85,SWEDEN SWEDENLUNG ADMINISTRATION LIQUID FOR INHALATION1.0X4.0X5.0X2.0 ML VIAL1/7/2011
1122NDA/MAL/HDP/2707KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMCLOXACLOXACILLIN250MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD-PLOT M 444B STRETCHER ROAD NTINDAUGANDAORAL SOLID ORDINARY CAPSULES100.0 CAPSULE CONTAINER,250.0 CAPSULE CONTAINER,500.0 CAPSULE CONTAINER,1000.0 CAPSULE CONTAINER,10.0 CAPSULE CONTAINER1/7/1997
1123NDA/MAL/HDP/2708MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDHYPER TABLETSPROPRANOLOL HYDROCHLORIDE40MGTORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506INDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X2.0X50.0 TABLET BLISTER1/7/2000
1124NDA/MAL/HDP/2710GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDAUGMENTIN BDAMOXICILLIN + CLAVULANIC ACID500 MG + 125 MGSMITHKLINE BEECHAM PHARMACEUTICALS,-CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QH UNITED KINGDOMORAL SOLID ORDINARY TABLETS1.0X14.0 TABLET BLISTER1/7/1997
1125NDA/MAL/HDP/2712NEON LABARATORIES LTD.NORVIK ENTERPRISES LIMITEDANAWINBUPIVACAINE0.025%W/VNEON LABORATORIES LTD-PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROAD INDIAPARENTERAL ORDINARY VIALS1.0X20.0 ML VIAL1/7/2014
1126NDA/MAL/HDP/2715MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDLAMIVUDINELAMIVUDINE150MGMYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE
INDIAORAL SOLID ORDINARY TABLETS1.0X1.0X60.0 TABLET CONTAINER1/7/2008
1127NDA/MAL/HDP/2717CENTAUR PHARMACEUTICALS PRIVATE LIMITEDGITTOES PHARMACEUTICALS LIMITEDOCUMYCIN EYE OINTMENTCHLORAMPHENICOL1%W/WCENTAUR PHARMA PVT. LTD-PLOT 39-41, TIVIM INDUSTRIAL ESTATE, KARASWADA, MAPUSA GOA INDIA INDIAOPHTHALMIC OINTMENTS1.0X3.5 G TUBE1/7/2000
1128NDA/MAL/HDP/2718SHAIGAN PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDGYNOMINZZSHAIGAN PHARMACEUTICALS (PVT) LIMITED-14 KM ADYALA RD, RAWALPINDI, PAKISTAN PAKISTANORAL SOLID ORDINARY TABLETS1.0X2.0 TABLET BLISTER1/7/1997
1129NDA/MAL/HDP/2719SEDICO PHARMACEUTICAL CO.WIDE SPECTRUM ENTERPRISES (U) LIMITEDLORASEDLORATADINE10MGSEDICO PHARMACEUTICAL CO.-1ST INDUSTRIAL ZONE 6 TH OCTOBER CITY GIZA,EGYPT EGYPTORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET STRIP1/7/2007
1130NDA/MAL/HDP/2720SEDICO PHARMACEUTICAL CO.WIDE SPECTRUM ENTERPRISES (U) LIMITEDFLUCAMOX 250MG POWDER FOR ORAL SUSPENSIONAMOXICILLIN +FLUCLOXACILLIN125MG/5ML+125MG/5MLSEDICO PHARMACEUTICAL CO.-1ST INDUSTRIAL ZONE 6 TH OCTOBER CITY GIZA,EGYPT EGYPTORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X80.0 ML BOTTLE1/7/2007
1131NDA/MAL/HDP/2721MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDPRIMAFEN TABLETIBUPROFEN + PARACETAMOL400MG + 325MGTORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER1/7/2007
1132NDA/MAL/HDP/2722MACK BROWN PHARMACEUTICALS PVT LIMITEDSHURIK LTDNO SORESCHOLINE SALICYLATE/LIDOCAINE8.7%W/W+2%W/WTORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506INDIAORAL TOPICAL GELS AND SOLS1.0X10.0 G TUBE1/7/2007
1133NDA/MAL/HDP/2725ASTRA PHARMA (U) LTDASTRA PHARMA (U) LIMITEDSTREPTOMYCIN SULPHATE FOR INJECTIONSTREPTOMYCIN SULPHATE1GMREYOUNG PHARMACEUTICAL CO. LIMITED-NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA CHINAPARENTERAL ORDINARY DRY VIALS1.0X5.0X1.0X10.0 VIAL CARTON1/7/2011
1134NDA/MAL/HDP/2734DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDGAMA PHARMACEUTICALS (U) LIMITEDAMLODAR-10AMLODIPINE BESILATE10MGDAR AL DAWA-NA'UR PLANT AMMANJORDANORAL SOLID ORDINARY CAPSULES1.0X2.0X14.0 CAPSULE BLISTER1/7/2009
1135NDA/MAL/HDP/2737SHAIGAN PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDSENEX FORTESECNIDAZOLE1GSHAIGAN PHARMACEUTICALS (PVT) LTD-14TH KM, ADYALA ROAD, RAWALPINDI-PAKISTAN PAKISTANORAL SOLID ORDINARY TABLETS1.0X1.0X2.0 TABLET BLISTER
1136NDA/MAL/HDP/2738WIN-MEDICARE PVT LTDSURGIPHARM (U) LIMITEDHEPA-MERZ INFUSIONL-ORNITHINE- L-ASPARTATE5G/10MLWIN-MEDICARE PRIVATE LIMITED-MEERUT-MUZAFFARNAGAR ROAD, MODIPURAM - 250110 UTTAR PRADESH INDIAPARENTERAL ORDINARY I V VIALS1.0X5.0X10.0 ML VIAL1/7/2001
1137NDA/MAL/HDP/2739REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDBISPANOL TABLETHYOSCINE BUTYLBROMIDE10MGREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA KENYAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER1/7/2001
1138NDA/MAL/HDP/2743BEIJING HOLLEY COTEC PHARMA CHINASUPER PHARMACEUTICALS LIMITEDDUO-COTECXINDIHYDROARTEMISININ + PIPERAQUINE PHOSPHATE40MG + 320MGKBN- ZHEJIANG PHARMACEUTICAL CO. LTD-NO. 340 YUNHAI ROAD JIAXING ECONOMIC DEVELOPMENT ZONE, JIAXING CITY, ZHEJIANG PROVINCE CHINAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X9.0 TABLET BLISTER,1.0X1.0X4.0 TABLET BLISTER,1.0X30.0X9.0 TABLET BLISTER1/7/2005
1139NDA/MAL/HDP/2745RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDRENFORMINMETFORMIN HYDROCHLORIDE500MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA UGANDAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER1/7/2015
1140NDA/MAL/HDP/2746DENK PHARMA GMBH & CO. KGBENLE CONSULT LIMITEDACYCLOVIR DENK 200ACYCLOVIR200MGDENK PHARMA GMBH &CO.KG-PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANY GERMANYORAL SOLID ORDINARY TABLETS1.0X25.0 TABLET BLISTER1/7/2000
1141NDA/MAL/HDP/2753MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDPRASILMETOCLOPRAMIDE HYDROCHLORIDE10MGTORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER1/7/2009
1142NDA/MAL/HDP/2754FDC LTDAIVEEN (U) LIMITEDZATHRIN 500AZITHROMYCIN DIHYDRATE500MGFDC LIMITED -PLOT NO. L121 B PHASE 111A VERNA INDUSTRIAL ESTATE VERNA SALCETE GOA 403 722INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X1.0X3.0 TABLET BLISTER,1.0X50.0X1.0X1.0X3.0 TABLET BLISTER1/7/2016
1143NDA/MAL/HDP/2756PFIZER LABORATORIES LTDLABOREX UGANDA LIMITEDCYTOTECMISOPROSTOL200MCGPIRAMAL HEALTHCARE LIMITED-WALTON ROAD MORPETH NORTHUMBERLAND NE 613YAUNITED KINGDOMORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X14.0 TABLET BLISTER1/7/2010
1144NDA/MAL/HDP/2760REGAL PHARMA U LIMITEDREGAL PHARMA (U) LTDDELASED DRY COUGH SYRUPDIPHENHYDRAMINE HYDROCHLORIDE+DEXTROMETHORPHAN+SODIUM CITRATE+MENTHOL14MG+6.5MG+57MG+2MGREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA KENYAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE1/7/1997
1145NDA/MAL/HDP/2761REMEDICA LTDGOODMAN INTERNATIONAL LTDTRIFLUOPERAZINETRIFLUOPERAZINE HYDROCHLORIDE5MGREMEDICA LTD-AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE, 3056 LIMASSOL CYPRUSORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER1/7/2010
1146NDA/MAL/HDP/2763ELYS CHEMICAL INDUSTRIES LTDVELVET PHARMA LIMITEDCANDISTATCLOTRIMAZOLE100MGELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBI KENYAVAGINAL SUPPOSITORIES1.0X2.0X3.0 PESSARY STRIP1/7/1997
1147NDA/MAL/HDP/2773REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDBISPANOL ELIXIRHYOSCINE-N-BUTYLBROMIDE5MG/5MLREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA, NAIROBI, KENYA KENYAORAL LIQUID ORDINARY SYRUPS1.0X1.0X60.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE1/7/2004
1148NDA/MAL/HDP/2774ACINO PHARMA AG -GOODMAN INTERNATIONAL LTDBACTIFLOX NEO 500CIPROFLOXACIN500MGACINO PHARMA AG.-DORNACHERSTRASSE 114, CH-4147 AESCH, SWITZERLAND ACINO PHARMA AG-BIRSWEG 2, 4253, LIESBERG - SWITZERLAND SWITZERLANDORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER1/7/2005
1149NDA/MAL/HDP/2776UNIQUE PHARMACEUTICALS LABORATORIESPLANET PHARMACEUTICALS UGANDA LTDTENSIMIN-100ATENOLOL100MGUNIQUE PHARMACEUTICAL LABORATORIES (A DIV. OF J.B CHEMICALS & PHARMACEUTICALS LTD)-216-219 GIDC INDUSTRIAL AREA PANOLI 394 116 DIST BHARUCHINDIAORAL SOLID ORDINARY TABLETS10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,14.0X10.0 TABLET BLISTER1/7/1997
1150NDA/MAL/HDP/2779BROOKES PHARMACEUTICAL LABORATORIES LHARLEYS UGANDA LIMITEDPYODINE SURGICAL SCRUBPOVIDONE IODINE7.5%W/VBROOKES PHARMACEUTICALS LABORATORIES (PAKISTAN) LTD-PLOT 58 SECTOR 15 KORANGI
INDUSTRIAL AREA, KARACHI-PAKISTAN
PAKISTANTOPICAL EXTERNAL LIQUIDS1.0X60.0 ML BOTTLE,1.0X450.0 ML BOTTLE,1.0X500.0 ML BOTTLE1/7/2000
1151NDA/MAL/HDP/2781INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDCARVETAS 6.25CARVEDILOL6.25MGINTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER1/7/2011
1152NDA/MAL/HDP/2783NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDVOLTAREN SUPPOSITORIES 25MGDICLOFENAC SODIUM25MGDELPHARM HUNINGUE S.A.S--SITE INDUSTRIAL HUNINGUE26, RUE DE LA CHAPELLE, F-68330, HUNINGUE FRANCERECTAL SYSTEMIC SUPPOSITORIES1.0X1.0X10.0 SUPPOSITORY STRIP1/7/2006
1153NDA/MAL/HDP/2787MEDOPHARM PRIVATE LIMITEDPLANET PHARMACEUTICALS UGANDA LTDMEDOMOX 125 DTAMOXICILLIN125MGMEDOPHARM PVT LTD.-NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADUINDIAORAL SOLID ORDINARY SOLUBLE TABLETS1.0X2.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER1/7/2013
1154NDA/MAL/HDP/2788RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDMULTIRENMULTIINGREDIENTN/ARENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA UGANDAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER1/7/2010
1155NDA/MAL/HDP/2796ASTRA PHARMA (UK) LTDASTRA PHARMA (U) LIMITEDBENZYLPENICILLIN INJECTIONBENZYLPENICILLIN SODIUM1,000,000I.UCSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG)CO. LTD-NO. 88, YANGZI ROAD, SHIJIAZHUANG CITY, HEBEI PROVINCE(WORKSHOP 406 AND 407) CHINAPARENTERAL ORDINARY DRY VIALS1.0X10.0 VIAL CARTON,1.0X50.0 VIAL CARTON1/7/2001
1156NDA/MAL/HDP/2797RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDLUMARENARTEMETHER + LUMEFANTRINE20 MG + 120 MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA UGANDAORAL SOLID ORDINARY TABLETS1.0X3.0X8.0 TABLET BLISTER1/7/2010
1157NDA/MAL/HDP/2800NOVO NORDISKSTAR PHARMACEUTICALS LTDACTRAPID HM PENFILLHUMAN INSULIN100 I.U/MLNOVO NORDISK PHARMA-NOVO ALLE NOVO NORDISK PRODUCTION SAS-45 AVENUE D’ORLEANS, 28000 CHARTRES, FRANCE NOVO NORDISK PRODUCAO FARMACEUTICA DO BRASIL LTDA-AV. "C", 1413, DISTRITO INDUSTRIAL - 390404 004 MONTES CLAROS, MINAS GERAIS - BRAZIL DENMARKPARENTERAL ORDINARY PRE-FILLED PENS1.0X1.5 ML FLEXPEN,1.0X3.0 ML FLEXPEN1/7/1997
1158NDA/MAL/HDP/2802CENTAUR PHARMACEUTICALS PRIVATE LIMITEDGITTOES PHARMACEUTICALS LIMITEDTASOLCLOBETASOL0.05%W/WCENTAUR PHARMACEUTICALS PVT LTD --PLANT II PLOT 39-41 TIVIM INDUSTRIAL ESTATE KARASWADA MAPUSA GOA 403 526INDIATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE1/7/2005
1159NDA/MAL/HDP/2805REMEDICA LTDGOODMAN INTERNATIONAL LTDNIFELAT 20R TABLETSNIFEDIPINE20MGREMEDICA LIMITED -AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUS CYPRUSORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER1/7/1997
1160NDA/MAL/HDP/2807GUILIN PHARMACEUTICALS CO.LTDTRIDEM PHARMA UGANDA LIMITEDASAQ GPSCARTESUNATE + AMODIAQUINE100 MG + 270 MGGUILIN PHARMACEUTICALS CO. LTD-NO 43 SHANGHAI ROAD GUILIN GUANGXI CHINACHINAORAL SOLID ORDINARY TABLETS1.0X20.0X3.0 TABLET BLISTER,1.0X20.0X6.0 TABLET BLISTER,1.0X25.0X3.0 TABLET BLISTER,1.0X25.0X6.0 TABLET BLISTER1/7/2011
1161NDA/MAL/HDP/2811REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDSULPHUR OINTMENTSULPHUR PRECIPITATED10%W/WREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA KENYATOPICAL EXTERNAL OINTMENTS1.0X25.0 G TUBE1/7/2001
1162NDA/MAL/HDP/2812DAFRA PHARMA LTDMULTIPHAR UGANDA LIMITEDCO-ARTESIANEBETA ARTEMETHER + LUMEFANTRINE180 MG/60ML + 1080 MG/60MLS KANT HEALTHCARE LIMITED-1802 – 1805, G.I.D.C., PHASE III, VAPI -396195 GUJARAT, INDIA. NETHERLANDSORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X60.0 ML BOTTLE1/7/2005
1163NDA/MAL/HDP/2813REGAL PHARMA U LIMITEDREGAL PHARMA (U) LTDINTACYCLINE SKIN OINTMENTTETRACYCLINE HYDROCHLORIDE3%W/WREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA KENYATOPICAL EXTERNAL OINTMENTS1.0X15.0 G TUBE1/7/1997
1164NDA/MAL/HDP/2816CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDCATENOL-100 TABLETSATENOLOL100MGCADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA INDIAORAL SOLID ORDINARY TABLETS10.0X10.0 TABLET BLISTER1/7/1997
1165NDA/MAL/HDP/2821LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDDIOLIN-MGLIBENCLAMIDE+METFORMIN HYDROCHLORIDE TABLETS5MG+500MGLINCOLN PHARMACEUTICAL LIMITED..-LINCOLN PHARMACEUTICALS LIMITED, TRIMUL ESTATE, KHATRAJ, TAL. KALOL, DIST. GANDHINAGAR INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET STRIP1/7/2011
1166NDA/MAL/HDP/2826GLAXO SMITH KLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDPIRITON SYRUPCHLORPHENIRAMINE MALEATE4MG/10ML GLAXOSMITHKLINE-LIKONI ROAD IND. AREA, NAIROBI KENYAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE,1.0X2.0 L BOTTLE1/7/1997
1167NDA/MAL/HDP/2835LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDSOLUDINE-MPOVIDONE IODINE / METRONIDAZOLE5%W/W / 1%W/WLINCOLN PHARMACEUTICALS LIMITED-10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
INDIATOPICAL EXTERNAL OINTMENTS1.0X20.0 G TUBE,1.0X125.0 G TUBE1/7/2011
1168NDA/MAL/HDP/2838MODI MUNDI PHARMA PVT LTDSURGIPHARM (U) LIMITEDDILCONTIN XL 120CONTROLLED RELEASE TABLETS OF DILTIAZEM HYDROCHLORIDE120MGMODI MUNDIPHARMA (PVT) LTD-MEERUT - MUZAFFARNAGAR ROAD, MODIPURAM, UTTAR PRADESH ESTATE INDIAORAL SOLID RETARD FILM-COATED TABLETS1.0X10.0X10.0 TABLET STRIP1/7/2010
1169NDA/MAL/HDP/2848MSD (PTY) LIMITED SASURGIPHARM (U) LIMITEDDIPROGENTA OINTMENTBETAMETHASONE /GENTAMICIN SULPHATE0.5MG/G+1.0MG/GSCHERING-PLOUGH LABONV-INDUSTRIE PARK 30, B-220 HEIST-OP-DEN-BERG, BELGIUM CANADATOPICAL EXTERNAL OINTMENTS1.0X15.0 G TUBE,1.0X30.0 G TUBE1/7/2001
1170NDA/MAL/HDP/2868CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDLOSACAR 50LOSARTAN POTASSIUM50MGCADILA HEALTH CARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X10.0X7.0 TABLET BLISTER1/7/2003
1171NDA/MAL/HDP/2869GLAXO SMITHKLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDPRIORIX VACCINEMEASLES + MUMPS + RUBELLA103.0CCID50 + 103.7CCID50 + 103.0CCID50GLAXO SMITHKLINE BIOLOGICALS S.A-RUE DE L'INSTITUT, 89 B-1330 RIXENSART BELGIUMPARENTERAL ORDINARY DRY VIALS1.0X0.5 ML VIAL (1 DOSE)1/7/2010
1172NDA/MAL/HDP/2873INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDHELIGO KITTINIDAZOLE/CLARITHROMYCIN/LANSOPRAZOLE500MG+ 250MG+30MGINTAS PHARMACEUTICALS LTD .-PLOT NOS. 457, 458 & 191/218P SARKHEJ-BAVLA HIGHWAY MATODA SANAND AHMEDABAD GUJARAT INDIAORAL SOLID ORDINARY TABLETS1.0X7.0X6.0 TABLET BLISTER1/7/2001
1173NDA/MAL/HDP/2878PHARCO PHARMACEUTICALS LTDWIDE SPECTRUM ENTERPRISES (U) LIMITEDFARCOCIN CREAMGENTAMYCIN SULPHATE0.1%W/WPHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT.
P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT
EGYPTTOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE1/7/2000
1174NDA/MAL/HDP/2879CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDOFLIN-200OFLOXACIN200MGCADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X20.0 TABLET BLISTER,1.0X2.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,10.0X1.0X10.0 TABLET BLISTER1/7/2004
1175NDA/MAL/HDP/2880REMEDICA LTDGOODMAN INTERNATIONAL LTDCARBIMAZOLE 5CARBIMAZOLE5MGREMEDICA LIMITED,-LIMASSOL INDUSTRIAL ESTATE, AHARNON ST, P.O. BOX 51706,3508 LIMASSOL CYPRUSORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER1/7/2010
1176NDA/MAL/HDP/2885MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDFORECOX-TRACRIFAMPICIN + ISONIAZID + PYRAZINAMIDE + ETHAMBUTOL150MG + 75MG+ 400MG + 275MGMACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIA OXALIS LABS LIMITED-VILLAGE THEDA, P.O LODHIMAJRA, TEHSIL,BADDI, DIST.SOLAN, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X6.0 TABLET BLISTER,1.0X24.0X28.0 TABLET BLISTER1/7/2005
1177NDA/MAL/HDP/2891MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDTORVAST 20ATORVASTATIN20MGMACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER1/7/2006
1178NDA/MAL/HDP/2892UNIQUE PHARMACEUTICALS LABORATORIESPLANET PHARMACEUTICALS UGANDA LTDNICARDIA-20 TABLETSNIFEDIPINE20MGUNIQUE PHARMACEUTICAL LABORATORIES-PLOT NO. 215-219, G.I.D.C. INDUSTRIAL AREA,PANOLI — 394 116, GUJARAT, INDIA.
INDIAORAL SOLID ORDINARY TABLETS1.0X5.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER1/7/1997
1179NDA/MAL/HDP/2893DAWA LIMITEDSUPER MEDIC LTDSTOPACID SUSPENSIONMAGNESIUM TRISILICATE + ALUMINIUM HYDROXIDE250MG/5ML + 120MG/5MLDAWA-PLOT 7879, BABA DOGO ROAD RUARAKA, NAIROBI, KENYA KENYAORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE1/7/2009
1180NDA/MAL/HDP/2894EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDMUCOGEL SUSPENSIONDRIED ALUMINIUM HYDROXIDE + MAGNESSIUM HYDROXIDE + OXETHAZAINE8G/100ML + 2G/100ML + 0.2 G/100MLEGYPIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES CO EIPICO-10TH OF RAMADAN CITY-FIRST INDUSTRIAL AREA -EGYPTEGYPTORAL LIQUID ORDINARY SUSPENSIONS1.0X125.0 ML BOTTLE1/7/2005
1181NDA/MAL/HDP/2896KPI INDUSTRIES(1996) LTEDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDMCG CREAMMICONAZOLE NITRATE BP + CLOBETASOL PROPIONATE BP + GENTAMYCIN SULPHATE2.0%W/W + 0.05%W/W + 0.1 %W/WKPI INDUSTRIES (1996) LTD-PLOT NO.M444B STRETCHER RD, NTINDA, KAMPALA UGANDATOPICAL EXTERNAL CREAMS1.0X30.0 G TUBE,1.0X15.0 G TUBE,1.0X25.0 G TUBE1/7/2005
1182NDA/MAL/HDP/2898MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDTORVAST 10ATORVASTATIN10MGMACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER1/7/2006
1183NDA/MAL/HDP/2900MICRO LABS LTDLABOREX UGANDA LIMITEDGRAMOCEF-O-200CEFIXIME200MGMICRO LABS LIMITED, BOMMASANDRA -PLOT NO. 121-124 4TH PHASE K.I.A.D.B BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK BANGALORE 560 099 INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0 CAPSULE BLISTER1/7/2005
1184NDA/MAL/HDP/2902MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDMEGALIS-20TADALAFIL20MGMACLEODS PHARMACEUTICALS LIMITED (BLOCK –N1)-VILLAGE THEDA, P.O. LODHI MAJRA,TEHSIL BADDI, HIMACHAL PRADESH -174101,INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X15.0X1.0X4.0 TABLET STRIP1/7/2005
1185NDA/MAL/HDP/2905EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDBRONCHOPHANE SYRUPGUAIPHENESIN+EPHEDRINE HYDROCHLORIDE+DIPHENHYDRAMINE HYDROCHLORIDE+DEXTROMETHORPHAN50MG+7.5MG+5MG+4.58MGEGYPT INTERNATIONAL PHARMACEUTICAL INDUSTRIES CO. EIPICO-10TH STREET RAMADAN CITY, FIST INDUSTRIES ARE EGYPTORAL LIQUID ORDINARY SYRUPS1.0X1.0X125.0 ML BOTTLE1/7/2007
1186NDA/MAL/HDP/2907BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDLONART DSARTEMETHER + LUMEFANTRINE80 MG + 480 MGBLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X6.0 TABLET BLISTER1/7/2008
1187NDA/MAL/HDP/2908SHOSAAN ASIC PACIFICRENE PHARMACY LTDPAINGO MEDICATED CREAMMETHYLSALICYLATE+CAPSICUM OLEORESIN+TURPENTINE OIL15%W/W + 1%W/W + 1.47%W/WNEM LABORATORIES PVT LTD-PLOT NO. 133 KRISHNA IND. ESTATE, VASAI E,DIST PALGHAR- 401210, MAHARASHTRA STATE INDIATOPICAL EXTERNAL CREAMS1.0X2.0X15.0 G TUBE1/7/2010
1188NDA/MAL/HDP/2910CIPLA LTD.CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDTENVIR EMTENOFOVIR DISOPROXIL FUMARATE + EMTRICITABINE300MG+200MGCIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X30.0 TABLET BOTTLE1/7/2009
1189NDA/MAL/HDP/2911ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDAXCEL LORATADINELORATADINE10MGKOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA MALAYSIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER1/7/2010
1190NDA/MAL/HDP/2914REGAL PHARMA U LIMITEDREGAL PHARMA (U) LTDCHLOROCIDE SUSPENSIONCHLORAMPHENICOL PALMITATE125MG/5MLREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA KENYAORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE1/7/1997
1191NDA/MAL/HDP/2917REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDCETAMOL TABLETSPARACETAMOL500MGREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA KENYAORAL SOLID ORDINARY TABLETS1.0X50.0X2.0 TABLET STRIP,1.0X500.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET STRIP,1.0X100.0X10.0 TABLET BLISTER1/7/1997
1192NDA/MAL/HDP/2919CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDODIMONT 5MONTELUKAST5MGCADILA HEALTHCARE LTD---SARKHEJ-PLOT 417,419,420, SARKHEJ-BAVLA NH NO.8A,VILLAGE: MORAIYA TAL: SANAND DISTRICT AHMEDABAD 382210 INDIAORAL SOLID ORDINARY CHEWABLE TABLETS1.0X3.0X10.0 TABLET BLISTER1/7/2011
1193NDA/MAL/HDP/2920CENTAUR PHARMACEUTICALS LTDGITTOES PHARMACEUTICALS LIMITEDTRANSLIPO -C CREAMCLOTRIMAZOLE1%W/WCENTAUR PHARMACEUTICALS PVT LTD --PLANT II PLOT 39-41 TIVIM INDUSTRIAL ESTATE KARASWADA MAPUSA GOA 403 526INDIATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE,1.0X20.0 G TUBE,1.0X10.0 G TUBE1/7/2001
1194NDA/MAL/HDP/2940CENTAUR PHARMACEUTICALS PVT. LTDGITTOES PHARMACEUTICALS LIMITEDBENZOX 5 GELBENZOYL PEROXIDE5%W/WCENTAUR PHARMACEUTICALS LTD- PLOT NO. 39 TIVIN IN
INDIATOPICAL EXTERNAL OTHER GELS/SOLS1.0X20.0 G TUBE1/7/2005
1195NDA/MAL/HDP/2941CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDATORVA 20ATORVASTATIN20MGCADILA HEALTH CARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X5.0X7.0 TABLET BLISTER1/7/2005
1196NDA/MAL/HDP/2942CENTAUR PHARMACEUTICALS PRIVATE LIMITEDGITTOES PHARMACEUTICALS LIMITEDARGISSEPT CREAMCHOLRHEXIDINE GLUCONATE/SILVER SULPHADIAZINE0.2%W/W / 1%W/WCENTAUR PHARMACEUTICALS PVT LTD --PLANT II PLOT 39-41 TIVIM INDUSTRIAL ESTATE KARASWADA MAPUSA GOA 403 526INDIATOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE,1.0X10.0 G TUBE1/7/2005
1197NDA/MAL/HDP/2946GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDTRIMAGO ORAL SUSPENSIONCO-TRIMOXAZOLE240MG/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 SUSPENSIONS1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE1/7/1998
1198NDA/MAL/HDP/2947GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDTRIMAGO TABLETSCO-TRIMOXAZOLE480MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X100.0X10.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X250.0 BLISTER CARTON1/7/1998
1199NDA/MAL/HDP/2948DENK PHARMA GMBH & CO KGBENLE CONSULT LIMITEDMETFORMIN DENK 850METFORMIN HYDROCHLORIDE850MGDENK PHARMA GMBH &CO.KG--PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANY GERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X15.0 TABLET BLISTER,1.0X8.0X15.0 TABLET BLISTER1/7/2007
1200NDA/MAL/HDP/2950PFIZER LABORATORIES PTY LTDLABOREX UGANDA LIMITEDXALATANLATANOPROST0.005%W/VPFIZER MANUFACTURING -NV/NA, RIJKSWEG 12 2870, PUURS BELGIUMOPHTHALMIC DROPS1.0X2.5 ML BOTTLE1/7/1998
1201NDA/MAL/HDP/2951BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDLONART FORTE TABLETSARTEMETHER + LUMEFANTRINE40 MG + 240 MGBLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X2.0X6.0 TABLET BLISTER1/7/2007
1202NDA/MAL/HDP/2957MEDIPHARM SALES LIMITEDABACUS PHARMA (AFRICA) LIMITEDMEDITROLCALCITRIOL0.25MCGMEGA LIFE SCIENCES LIMITED-: PLANT I : 384 SOI 6, PATTANA 3 ROAD, BANGPOO INDUSTRIAL ESTATE, SAMUTPRAKAN 10280, THAILAND THAILANDORAL SOLID ORDINARY CAPSULES1.0X6.0X5.0 CAPSULE BLISTER,1.0X3.0X10.0 CAPSULE BLISTER1/7/2009
1203NDA/MAL/HDP/2959REGAL PHARMA U LIMITEDREGAL PHARMA (U) LTDCETAMOL SYRUPPARACETAMOL120MG/5MLREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA KENYAORAL LIQUID ORDINARY SYRUPS1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE1/7/1997
1204NDA/MAL/HDP/2960DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDGAMA PHARMACEUTICALS (U) LIMITEDCLAVODARAMOXICILLIN/CLAVULANIC ACID400MG/57MGDAR AL DAWA-NA'UR PLANT AMMANJORDANORAL SOLID ORDINARY GRANULES1.0X70.0 ML BOTTLE1/7/2010
1205NDA/MAL/HDP/2969UNIQUE PHARMACEUTICALS LTDPLANET PHARMACEUTICALS UGANDA LTDTENSIMIN-50ATENOLOL50MGUNIQUE PHARMACEUTICAL LABORATORIES (A DIV. OF J.B CHEMICALS & PHARMACEUTICALS LTD)-216-219 GIDC INDUSTRIAL AREA PANOLI 394 116 DIST BHARUCHINDIAORAL SOLID ORDINARY TABLETS10.0X10.0 TABLET BLISTER,14.0X10.0 TABLET BLISTER1/7/1997
1206NDA/MAL/HDP/2970USV PRIVATE LIMITEDABACUS PHARMA (AFRICA) LIMITEDGLYCOMET 500METFORMIN500MGFREDUN PHARMACEUTICALS LIMITED---14,15,16 ZORABIAN INDUSTRIAL COMPLEX PALAGHAR (EAST), DIST THANE 401 404 INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER1/7/2000
1207NDA/MAL/HDP/2971TORRENT PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.LEFRA-20 TABLETSLEFLUNOMIDE20MGTORRENT PHARMACEUTICALS LTD-INDRAD-382 721, DIST.MEHSANA,INDIA.AT:VILL.MANAKPUR,TEH.NALAGARH,DIST.SOLAN(H.P.) INDIAORAL SOLID ORDINARY TABLETS1.0X5.0X10.0 TABLET BLISTER1/7/2004
1208NDA/MAL/HDP/2979ROYAL GROUPABACUS PHARMA (AFRICA) LIMITEDBETADERM N CREAMBETAMETHASONE VALERATE + NEOMYCIN0.1%W/W + 0.5%W/WATCO LABORATORIES PVT LTD-B-18,S.I.T.E KARACHI 75700, PAKISTAN PAKISTANTOPICAL EXTERNAL CREAMS1.0X5.0 G TUBE,1.0X15.0 G TUBE1/7/1997
1209NDA/MAL/HDP/2980BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDLONART TABLETSARTEMETHER + LUMEFANTRINE20 MG + 120 MGBLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X3.0X8.0 TABLET BLISTER,1.0X6.0 TABLET BLISTER,1.0X2.0X6.0 TABLET BLISTER,1.0X3.0X6.0 TABLET BLISTER,1.0X24.0 TABLET BLISTER,1.0X12.0 TABLET BLISTER,1.0X18.0 TABLET BLISTER,1.0X24.0 TABLET BLISTER1/7/2007
1210NDA/MAL/HDP/2982CENTAUR PHARMACEUTICALS PVT LTDGITTOES PHARMACEUTICALS LIMITEDNEURO-FORTE TABLETSVITAMIN B1 + VITAMIN B6 + VITAMIN B12200MG + 50MG + 1MGCENTAUR PHARMACEUTICALS LTD-PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X10.0 TABLET BLISTER1/7/2004
1211NDA/MAL/HDP/2983CIPLA LTD.CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDFUCOL 200FLUCONAZOLE200MGCIPLA LTD -PLOT NO. L-139, VERNA, GOA 403 722 INDIA CIPLA LTD KURKUMBH-D-7 MIDC INDUSTRIAL AREA, KURKUMBH, TALUKA-DAUND, PUNE, MAHARASHTRA INDIAORAL SOLID ORDINARY CAPSULES1.0X5.0X1.0X4.0 CAPSULE BLISTER1/7/2004
1212NDA/MAL/HDP/2990MICRO LABS LTDLABOREX UGANDA LIMITEDPULMOCEF-500CEFUROXIME AXETIL USP500MGMICRO LABS LTD--NO. 121-124 4TH PHASE K.I.A.D.B BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK BANGALORE 560 099INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X10.0 TABLET BLISTER,1.0X3.0X4.0 TABLET BLISTER1/7/2004
1213NDA/MAL/HDP/2995GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDGALLOPLOPERAMIDE HYDROCHLORIDE USP2MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIAORAL SOLID ORDINARY OTHER CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0 CAPSULE CONTAINER1/7/2007
1214NDA/MAL/HDP/3003GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOVIRACICLOVIR200MGAGOG 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,1.0X10.0 TABLET BLISTER1/7/2007
1215NDA/MAL/HDP/3005ACINO PHARMA AG -GOODMAN INTERNATIONAL LTDOLFEN-100 SR PROLONGED-RELEASE CAPSULESDICLOFENAC SODIUM100MGACINO PHARMA AG-BIRSWEG 2, 4253, LIESBERG - SWITZERLAND SWITZERLANDORAL SOLID RETARD CAPSULES1.0X10.0 CAPSULE BLISTER1/7/1997
1216NDA/MAL/HDP/3007INTAS PHARMACEUTICALS LIMITEDNORVIK ENTERPRISES LIMITEDTORTAS 5TORSEMIDE5MGINTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER1/7/2013
1217NDA/MAL/HDP/3009VENUS REMEDIES LIMITEDHARLEYS UGANDA LIMITEDSULBACTOMAX 1.5GCEFTRIAXONE+SULBACTAM1000MG+500MGVENUS REMEDIES LTD, UNIT II,-HILL TOP INDUSTRIAL ESTATE, JHARMAJTI, EPIP, PHASE-1 (EXTENSION), BHATOLI KALAN, BADDI -HP INDIAPARENTERAL ORDINARY DRY VIALS1.0X20.0 ML VIAL1/7/2009
1218NDA/MAL/HDP/3012WIN-MEDICARE PVT LTDSURGIPHARM (U) LIMITEDDICLOMOL TABLETSDICLOFENAC SODIUM50MGWIN MEDICARE PVT LIMITED-MEERUT, MUZAFFARNAGER ROAD, MODIPURAM – 250110, UTTAR
PRADESH - INDIA
INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER1/7/1998
1219NDA/MAL/HDP/3013GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOZOLEALBENDAZOLE400MGAGOG 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 TABLETS1.0X1.0X1.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER1/7/2007
1220NDA/MAL/HDP/3015CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDPENEGRA-50 TABLETSSILDENAFIL50MGCADILA HEALTHCARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO.203-213, KUNDAIM GOA, 403115, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X1.0X4.0 TABLET BLISTER,1.0X20.0X4.0 TABLET BLISTER1/7/2001
1221NDA/MAL/HDP/3019MJ BIOPHARM PVT LTDVITACARE LIMITEDBIOSULIN 30/70INSULIN SOLUBLE + INSULIN ISOPHANE30 I.U + 70 I.UMJ BIOPHARM PRT LTD-L-7 MIDC INDUSTRIAL AREA, TALOJA, NARI MUMBAI MAHARASHTRA INDIAPARENTERAL ORDINARY VIALS1.0X10.0 ML VIAL1/7/2008
1222NDA/MAL/HDP/3020M.J BIOPHARM PVT LTDVITACARE LIMITEDBIOSULIN NINSULIN ISOPHANE100 I.U/MLM.J .BIOPHARM-L7, M.I.D.C INDUSTRIAL AREA TALOJA, NAVI MUMBAI MAHARAHTRA INDIAPARENTERAL ORDINARY S C VIALS1.0X10.0 ML VIAL1/7/2008
1223NDA/MAL/HDP/3021GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDGLIBENCLAMIDE TABLETSGLIBENCLAMIDE5MGAGOG PHARMA LIMITED-PLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER1/7/2007
1224NDA/MAL/HDP/3023GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOTRAXLEVAMISOLE HYDROCHLORIDE40MGAGOG PHARMA LTD.-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIAORAL SOLID ORDINARY TABLETS10.0X10.0 TABLET STRIP,1.0X10.0X1.0X3.0 TABLET STRIP,1.0X500.0 TABLET CONTAINER1/7/2007
1225NDA/MAL/HDP/3024MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDLAMIVUDINE + NEVIRAPINE + ZIDOVUDINELAMIVUDINE + NEVIRAPINE + ZIDOVUDINE150MG + 200MG + 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 QUESTA CARE LIMITED-PLOT NO 209/7184 HOMABAY RD TERMINUS GATE NO-19, INDUSTRIAL AREA NAIROBI, KENYA.
INDIAORAL SOLID ORDINARY TABLETS1.0X60.0 TABLET BOTTLE1/7/2008
1226NDA/MAL/HDP/3029GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOZOLE SUSPENSIONALBENDAZOLE USP200 MG/ 5 MLAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X10.0 ML BOTTLE1/7/2007
1227NDA/MAL/HDP/3030MJ BIOPHARM PVT LTDVITACARE LIMITEDBIOSULIN RINSULIN SOLUBLE100 IU/MLM.J BIOPHARM PVT LTD --L-7 MIDC INDUSTRIAL AREA, DIST . RAIGAD , TALOJA , NAVI MUMBAI INDIAPARENTERAL ORDINARY S C VIALS1.0X10.0 ML VIAL1/7/2008
1228NDA/MAL/HDP/3032ACINO PHARMA AGGOODMAN INTERNATIONAL LTDXYLO-ACINO 0.05%XYLOMETAZOLINE0.05%W/VMERCKLE GMBH,-LUDWIG MERCKLE STRASSE3 D-89143 BLAUBEUREN GERMANYNASAL TOPICAL SPRAYS WITHOUT GAS1.0X10.0 ML BOTTLE1/7/2007
1229NDA/MAL/HDP/3035GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOFORTE TONICFERRIC AMMONIUM CITRATE + FOLIC ACID + PYRIDOXINE HCL + THIAMINE HCL + NICOTINAMIDE + VITAMIN B1250MG + 0.55MG + 2.4MG + 1.2MG + 11MG + 2.5MGAGOG PHARMA LIMITED-PLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIA INDIAORAL LIQUID ORDINARY SYRUPS1.0X200.0 ML BOTTLE,1.0X60.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE1/7/2007
1230NDA/MAL/HDP/3037GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOVIT SYRUPVITAMIN A + VITAMIN D3 + VITAMIN B1 + VITAMIN B2 + NIACINAMIDE + VITAMIN B12 + VITAMIN C1000I.U + 200I.U + 1.5MG + 1.5MG+ 10MG + 2.5MCG + 40MGAGOG PHARMA LIMITED-PLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIA INDIAORAL LIQUID ORDINARY SYRUPS1.0X1.0X60.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE1/7/2007
1231NDA/MAL/HDP/3040GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGODOXDOXYCYCLINE100MGAGOG PHARMA LIMITED-PLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIA INDIAORAL SOLID ORDINARY CAPSULES1.0X100.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER,1.0X100.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER1/7/2007
1232NDA/MAL/HDP/3044CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDPIRICAM-20 CAPSULESPIROXICAM20MGCADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA INDIAORAL SOLID ORDINARY CAPSULES10.0X10.0 CAPSULE BLISTER,2.0X10.0 CAPSULE BLISTER1/7/1997
1233NDA/MAL/HDP/3046GLAXO SMITHLINE LIMITEDUNITED HEALTHCARE DISTRIBUTORS LTDCLAVULINAMOXICILLIN + CLAVULANIC ACID400 MG + 57 MGGLAXO WELLCOME PRODUCTION-ZI DE LA PEYENNIERE, 53100, MAYENNE UNITED KINGDOMORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X70.0 ML BOTTLE1/7/2009
1234NDA/MAL/HDP/3048GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDTRIMAGO-DS TABLETSSULFAMETHOXAZOLE/TRIMETHOPRIM800MG/160MGAGOG PHARMA LIMITED-PLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X6.0X10.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER,1.0X10.0X10.0 TABLET CONTAINER,1.0X3.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER1/7/2007
1235NDA/MAL/HDP/3050SHAIGAN PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDPEFLOXPEFLOXACIN400MGSHAIGAN PHARMACEUTICALS (PVT) LTD-14TH KM, ADYALA ROAD, RAWALPINDI-PAKISTAN PAKISTANORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER
1236NDA/MAL/HDP/3051BETA HEALTHCARE UGANDA LIMITEDBETA HEALTHCARE UGANDA LIMITEDBETROZOLEDILOXANIDE FUROATE+METRONIDAZOLE BENZOATE+SIMETHICONE125MG+160MG+25MGBETA HEALTHCARE INTERNATIONAL LTD - -PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYA KENYAORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE1/7/2005
1237NDA/MAL/HDP/3057GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDCOLD-A-GO CAPSULESPARACETAMOL + PHENYLEPHRINE HYDROCHLORIDE + DIPHENHYDRAMINE + CAFFEINE400MG + 5MG + 12.5MG + 30MGAGOG PHARMA LIMITED-PLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIA INDIAORAL SOLID ORDINARY CAPSULES1.0X2.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER1/7/2007
1238NDA/MAL/HDP/3058SANOFI-AVENTISSURGIPHARM (U) LIMITEDXATRAL LP 10MGALFUZOSIN10MGSANOFI WINTHROP INDUSTRIE,-30-36, AVENUE GUSTAVEEIFFEL BP 27166 - 37071 TOURS CEDEX 2 FRANCEORAL SOLID ORDINARY COATED TABLETS1.0X3.0X10.0 TABLET BLISTER1/7/2008
1239NDA/MAL/HDP/3060GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDKETOS TABLETKETOCONAZOLE USP200 MGAGOG PHARMA LIMITED-PLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/7/2007
1240NDA/MAL/HDP/3064GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDTIN-TIN TABLETSTINIDAZOLE500MGAGOG 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 TABLETS1.0X4.0 TABLET BLISTER1/7/2007
1241NDA/MAL/HDP/3067GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDPROMAGO SYRUPPROMETHAZINE5MG/5MLAGOG PHARMA LIMITED-PLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIA INDIAORAL LIQUID ORDINARY SYRUPS1.0X1.0X100.0 ML BOTTLE,1.0X1.0X60.0 ML BOTTLE1/7/2007
1242NDA/MAL/HDP/3069GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOMOVE CAPSULESPIROXICAM20MGAGOG 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,1.0X100.0 CAPSULE CONTAINER1/7/2007
1243NDA/MAL/HDP/3072GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOMOL TABLETS(THANE)PARACETAMOL500 MGAGOG PHARMA LIMITED-PLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER1/7/1998
1244NDA/MAL/HDP/3073COSMOS LTDASTRA PHARMA (U) LIMITEDCARDINOL TABLETATENOLOL50MGCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI KENYAORAL SOLID ORDINARY FILM-COATED TABLETS2.0X14.0 TABLET STRIP1/7/1997
1245NDA/MAL/HDP/3076ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDARISTO TELVAS 40TELMISARTAN40MGARISTO PHAMACUTLAB PVT LTD-PLOT NO.208 NEW INDUSTRIAL AREA NO.2 MANIDIDEEP 462.046INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET STRIP,3.0X10.0 TABLET BLISTER1/7/2007
1246NDA/MAL/HDP/3077REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDUNISTEN HC CREAMCLOTRIMAZOLE + HYDROCORTISONE1%W/W + 1%W/WREGAL PHERMACUTICALS -PLOT 7879/18 OFF BABA RWARAKA NAIROBI KENYAKENYATOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE1/7/2008
1247NDA/MAL/HDP/3078JOHNSON&JOHNSON PTY LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDSINUTAB ALLERGY CONGESTIONPARACETAMOL/ CHLORPHENIRAMINE/ EPHEDRINE500MG/ 2MG/ 30MGJOHNSON&JOHNSON PTY LTD.-EDMS BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICA SOUTH AFRICAORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER1/7/2010
1248NDA/MAL/HDP/3083ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDARISTO TELVAS 80TELMISARTAN80MGARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO.II,MANDIDEEEP PRADESH INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET STRIP,3.0X10.0 TABLET STRIP1/7/2007
1249NDA/MAL/HDP/3085GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOCOLD TABLETSPARACETAMOL+PHENYLEPHRINE HCL+CAFFEINE+CHLORPHENIRAMINE HYDROCHLORIDE500.MG+5.0MG+30.0MG+2.0MGAGOG PHARMA LIMITED-PLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X25.0X4.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X4.0 TABLET BLISTER,1.0X50.0X4.0 TABLET BLISTER1/7/2007
1250NDA/MAL/HDP/3090PHARMA INTERNATIONAL COOMAB UGANDA LIMITEDCEFODOXCEFPODOXIME PROXETIL100MG/5MLPHARMA INTERNATIONAL CO.-AMMAN JORDAN PLANT
AL-QARTAL MARKETING DEPARTMENT
ALBUJAH COMPLEX, ALJUBAIHA
JORDANORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X50.0 ML BOTTLE1/7/2004
1251NDA/MAL/HDP/3091SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDONDIONDANSETRON2MG/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 AMPOULES1.0X2.0X5.0X2.0 ML AMPOULE1/7/2013
1252NDA/MAL/HDP/3092NOVARTIS PHARMA SERVICES INCSURGIPHARM (U) LIMITEDEXFORGE HCT 10MG/160MG/12.5MGAMLODIPINE + VALSARTAN + HYDROCHLOROTHIAZIDE10MG + 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 BLISTER1/7/2015
1253NDA/MAL/HDP/3095LEBEN LABORATORIES PVT LTDMALIX PHARMA (U) LIMITEDAMPHEN SUSPENSIONCHLORAMPHENICOL PALMITATE125MG/5MLLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE1/7/2007
1254NDA/MAL/HDP/3098AMOUN PHARMACEUTICAL COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDMOSEDINLORATADINE5MG/5MLAMOUN PHARMACEUTICALS CO. S.A.E-1ST INDUSTRIAL ZONE, EL-OBOUR CITY, EGYPT. EGYPTORAL LIQUID ORDINARY SYRUPS1.0X60.0 ML BOTTLE1/7/2004
1255NDA/MAL/HDP/3099PHARMA INTERNATIONAL COMPANYOMAB UGANDA LIMITEDZONA 0.1% CREAMHYDROCORTISONE 17-BUTYRATE0.1%W/WPHARMA INTERNATIONAL CO.,-AL-QASTAL AREA, AIRPORT ROAD, 11941, AMMAN JORDANTOPICAL EXTERNAL CREAMS1.0X1.0X30.0 G TUBE1/7/2007
1256NDA/MAL/HDP/3101DAWA LIMITEDSUPER MEDIC LTDDACOLD SYRUPPARACETAMOL + PSEUDOEPHEDRINE HCL + CHLORPHENIRAMINE MALEATE120MG/5ML+10MG/5ML+2MG/5MLDAWA LTD-BABA DOGO ROAD RUARAKAKENYAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE1/7/2010
1257NDA/MAL/HDP/3104LEBEN LABORATORIES PVT LTDMALIX PHARMA (U) LIMITEDNYSTALEB ORAL SUSPENSIONNYSTATIN100000IU/MLLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X30.0 ML BOTTLE1/7/2007
1258NDA/MAL/HDP/3105CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDDEPIN-E RETARDNIFEDIPINE20MGCADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA INDIAORAL SOLID RETARD TABLETS1.0X10.0X10.0 TABLET STRIP1/7/1997
1259NDA/MAL/HDP/3108IPCA LABORATOIES LTDMEDVIN PHARMA LIMITEDZERODOLACECLOFENAC100MG IPCA LABORATORIES LTD,PLOT NO. T-139 -SEJAVTA, RATLAM-457 002 (M.P.) INDIA IPCA LABORATORIES LTD, PLOT NO. T-139-PLOT NO. T-139, MIDC, INDUSTRIAL ESTATE, TARAPUR, BOISOR, DIST- PALGHAR, THANE 401506, MAHARASHTRA. INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER1/7/2005
1260NDA/MAL/HDP/3111GLAXOSMITH KLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDCALPOLPARACETAMOL120MG/5MLGLAXOSMITHKLINE LIMITED - -78392-00507, VIWANDANI LIKONI ROAD NAIROBI KENYA KENYAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE1/7/1997
1261NDA/MAL/HDP/3116LABORATORY & ALLIED LTDHARLEYS UGANDA LIMITEDKLOXYCLOXACILLIN125MG/5MLLABORATORY & ALLIED LTD.---PLOT 209/10349 OFF MOMBASA RD NAIROBIKENYAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X1.0X100.0 ML BOTTLE,1.0X100.0 ML BOTTLE1/7/1997
1262NDA/MAL/HDP/3117KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTDTATA UGANDA LIMITEDHYDROCORTISONE SODIUM SUCCINATEHYDROCORTISONE SODIUM SUCCINATE100MGKARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD- #14, II PHASE PIA, BANGALORE 560058 INDIAPARENTERAL ORDINARY DRY VIALS1.0X10.0X100.0 MG VIAL,1.0X50.0X100.0 MG VIAL1/7/2010
1263NDA/MAL/HDP/3118CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDCIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDLUMARTEMARTEMETHER /LUMEFANTRINE20MG /120MGQUALITY CHEMICAL INDUSTRIES LIMITED. -PLOT NO. 1-7 LUZIRA INDUSTRIAL PARK, KAMPALA UGANDAORAL SOLID ORDINARY TABLETS1.0X1.0X24.0 TABLET BLISTER,1.0X30.0X18.0 TABLET BLISTER,1.0X30.0X24.0 TABLET BLISTER,1.0X30.0X12.0 TABLET BLISTER,1.0X30.0X6.0 TABLET BLISTER,1.0X1.0X18.0 TABLET BLISTER,1.0X1.0X12.0 TABLET BLISTER,1.0X1.0X6.0 TABLET BLISTER1/7/2011
1264NDA/MAL/HDP/3122USV PRIVATE LIMITEDABACUS PHARMA (AFRICA) LIMITEDGROVIT CHEWABLE TABLETSMULTI-INGREDIENTMULTI-INGREDIENTREMIDEX PHARMA PVT LTD- B-249+ 250 II STAGE PEENYA INDUSTRIAL ESTATE BANGLORE 560058.INDIAORAL SOLID ORDINARY CHEWABLE TABLETS1.0X3.0X10.0 TABLET BLISTER1/7/2002
1265NDA/MAL/HDP/3123BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDRECTOL 250 SUPPOSITORYPARACETAMOL BP250 MGBLISS GVS PHARMA LIMITED-PLOT NO. 10/11 SURVEY NO.39/1 DEWAN UDYOG
NAGAR ALIYALI VILLAGE TAL PALGHAR
DIST. THANE 401404 MAHARASHTRA
INDIA
INDIARECTAL SYSTEMIC PAEDIATRIC SUPPOSITORIES1.0X1.0X5.0 SUPPOSITORY BLISTER1/7/2007
1266NDA/MAL/HDP/3125DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDGAMA PHARMACEUTICALS (U) LIMITEDAMLODAR 5AMLODIPINE BESILATE5MGDAR AL DAWA-NA'UR PLANT AMMANJORDANORAL SOLID ORDINARY CAPSULES1.0X2.0X14.0 CAPSULE BLISTER1/7/2009
1267NDA/MAL/HDP/3134PANACEA BIOTEC PHARMA LTDVITACARE LIMITEDTOFF PLUSPARACETAMOL+CHLORPHENIRAMINE MALEATE+ DEXTROMETHORPHAN + PHENYLEPHRINE500 MG + 2 MG + 15 MG + 10 MGPANACEA BIOTEC PHARMA LIMITED-MALPURI BADDI, DISTRICT SOLAN, HIMACHAL PRADESH-173205 - INDIA INDIAORAL SOLID ORDINARY CAPSULES1.0X2.0X10.0 CAPSULE BLISTER1/7/2004
1268NDA/MAL/HDP/3136MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDTENOFOVIR DISOPROXIL FUMARATETENOFOVIR DISOPROXIL FUMARATE300MGMYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X30.0 TABLET BOTTLE1/7/2007
1269NDA/MAL/HDP/3139DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDGAMA PHARMACEUTICALS (U) LIMITEDOMEDAROMEPRAZOLE20MGDAR AI DAWA-NA UR PLANT,AMMAN,JORDAN JORDANORAL SOLID ORDINARY TABLETS1.0X1.0X14.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER1/7/2009
1270NDA/MAL/HDP/3141CIPLA LTD.CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDAMLOPRESS-5AMLODIPINE BESYLATE5MGCIPLA LTD-CIPLA LTD PLOT NO L-139,VERNA IND ESTATE, VERNA GOA INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X1.0X10.0 TABLET BLISTER1/7/2007
1271NDA/MAL/HDP/3144KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDULSECOMEPRAZOLE20MGKAMPALA PHARMECEUTICALS INDUSTRIES LTD-PLOT M444B STRETCHER RD, NTINDA KLA UGANDA UGANDAORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE STRIP1/7/2007
1272NDA/MAL/HDP/3147ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDARISTO TELVAS-H 40/12.5TELMISARTAN/HYDROCHLOROTHIAZIDE40MG/12.5MGARISTO PHARMACEUTICALS PVT LIMITED-PLOT 208, NEW INDUSTRIAL AREA NO II, MANDIDEEP-462 046 (DISTRICT) RAISEN, MADHYA PRADESH INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET STRIP,3.0X10.0 TABLET BLISTER1/7/2009
1273NDA/MAL/HDP/3155MEDREICH PLCSURGIPHARM (U) LIMITEDBIOFERONFERRIC AMMONIUM CITRATE + CYANOCOBALAMIN + FOLIC ACID200MG/5ML + 10MG/5ML + 750MCG/5MLTHE MADRAS PHARMACEUTICALS..-NO. 137B, OLD MAHABALIPURAM ROAD, KARAPAKKAM, CHENNAI 600096 INDIAORAL LIQUID ORDINARY SYRUPS1.0X200.0 ML BOTTLE1/7/2007
1274NDA/MAL/HDP/3156PFIZER LABORATORIES (PTY)PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDBENYLIN DAYTIME FLUPSEUDOEPHEDRINE HCL + IBUPROFEN30MG + 200MGJOHNSON&JOHNSON PTY LTD.-EDMS BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICA SOUTH AFRICAORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET STRIP1/7/2008
1275NDA/MAL/HDP/3158MJ BIOPHARM PVT LTDVITACARE LIMITEDGLIBEX-5GLIBENCLAMIDE5MGM.J BIOPHARM PVT LTD --L-7 MIDC INDUSTRIAL AREA, DIST . RAIGAD , TALOJA , NAVI MUMBAI INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET STRIP1/7/2012
1276NDA/MAL/HDP/3163NORVATIS PHARMA AGSURGIPHARM (U) LIMITEDVOLTAREN SUPPOSITORIES 50MGDICLOFENAC SODIUM50MGDELPHARM HUNINGUE S.A.S--SITE INDUSTRIAL HUNINGUE26, RUE DE LA CHAPELLE, F-68330, HUNINGUE FRANCERECTAL SYSTEMIC ADULT SUPPOSITORIES1.0X1.0X10.0 SUPPOSITORY STRIP1/7/2006
1277NDA/MAL/HDP/3167MJ BIOPHARM PVT LTDKIMSY MEDS LTDMONAN-0.5GMEROPENEM0.5GM.J BIOPHARM PVT LTD --L-7 MIDC INDUSTRIAL AREA, DIST . RAIGAD , TALOJA , NAVI MUMBAI INDIAPARENTERAL ORDINARY DRY VIALS1.0X0.5 G VIAL1/7/2010
1278NDA/MAL/HDP/3169SUN PHARMACEUTICAL INDUSTRIES LIMITEDSTAR PHARMACEUTICALS LTDRANOPHAGE ODMETFORMIN HCL1000MGSUN PHARMACEUTICAL INDUSTRIES LIMITED -INDUSTRIAL AREA 3, A.B. ROAD, DEWAS 455001, MADHYA PRADESH, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER1/7/2008
1279NDA/MAL/HDP/3175M.J.BIOPHARM PVT LTDVITACARE LIMITEDSPACOVINDROTAVERINE40MG M.J. BIOPHARM PVT. LTD-L-7, M.I.D.C. , TALOJA, DISTRICT RAIGAD - 410 208
NAVI MUMBAI, INDIA
INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER1/7/2012
1280NDA/MAL/HDP/3176AFRICURE PHARMACEUTICALS (INDIA) PRIVATELIMITEDROYAL PHARMA 2011 LIMITEDDOXYRONE-100DOXYCYCLINE HYDROCHLORIDE100AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED (755793)-PLOT 9-12,DEWAN & SONS INDUSTRIAL. AREA, VEOOR,PALGHAR-401404. INDIA. INDIAORAL SOLID ORDINARY CAPSULES1.0X100.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER1/7/2005
1281NDA/MAL/HDP/3177ROYAL GROUPABACUS PHARMA (AFRICA) LIMITEDBETADERM CREAMBETAMETHASONE VALERATE0.1%W/WATCO LABORATORIES PVT LTD-B-18,S.I.T.E KARACHI 75700, PAKISTAN PAKISTANTOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE,1.0X5.0 G TUBE1/7/1997
1282NDA/MAL/HDP/3178COSMOS LTDASTRA PHARMA (U) LIMITEDBENDURIC TABLETSBENDROFLUMETHIAZIDE5MGCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI KENYAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER1/7/2005
1283NDA/MAL/HDP/3179GOOD DAY PHARMACY LIMITEDPLANET PHARMACEUTICALS UGANDA LTDSULFUR OINTMENTSULPHUR10%W/WKREMOINT PHARMA PVT LTD---B-8 ADDITIONAL AMBERNATH MIDC OPP. ANAND NAGAR POLICE CHECK POST AMBERNATH (E) DIST THANE 421 506INDIATOPICAL EXTERNAL OINTMENTS1.0X1.0X25.0 G TUBE1/7/2013
1284NDA/MAL/HDP/3180MJ BIOPHARM PVT LTDVITACARE LIMITEDLOFIN 500METFORMIN HYDROCHLORIDE500MGM.J BIOPHARM PVT LTD --L-7 MIDC INDUSTRIAL AREA, DIST . RAIGAD , TALOJA , NAVI MUMBAI INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER1/7/2008
1285NDA/MAL/HDP/3184M.J BOPHARM PUT LTDKIMSY MEDS LTDMONANMEROPENEM1GM.J BIOPHARM PUT LTD -L-7 MIDC INDUSTRIOL DIST GAIDED TOLOJAINDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0 G VIAL1/7/2008
1286NDA/MAL/HDP/3191CIPLA LTD.CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDERECTO -100SILDENAFIL CITRATE100 MGCIPLA LIMITED PUNE-MIDC, KURKUMBH DISTRICT PUNE 413802 INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0 TABLET BLISTER1/7/2007
1287NDA/MAL/HDP/3192MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDANZAVIR-RATAZANAVIR + RITONAVIR300 MG + 100 MGMYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE
INDIAORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET CONTAINER1/7/2013
1288NDA/MAL/HDP/3193CIPLA LTD.CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDERECTO- 50SILDENAFIL CITRATE50MGCIPLA LIMITED PUNE-MIDC, KURKUMBH DISTRICT PUNE 413802 INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0 TABLET BLISTER1/7/2005
1289NDA/MAL/HDP/3197DENK PHARMA GMBH & CO. KGBENLE CONSULT LIMITEDTRIAM-DENK 40 INJECTIONTRIAMCINOLONE ACETONIDE40 MG/MLFISIOPHARMA S.R.L.-NUCLEOO INDUSTRIALE, 84020, PALOMONTE (SA) - ITALY ITALYPARENTERAL ORDINARY AMPOULES1.0X10.0X1.0 ML AMPOULE1/7/2004
1290NDA/MAL/HDP/3199MERCK SHARP & DOHME BV.SURGIPHARM (U) LIMITEDISENTRESSRALTEGRAVIR400MGZHEIJIANG HUAHAI PHARMACEUTICAL CO LTD -ZHEIJIANG HUAHAI PHARMACEUTICAL CO LTD XUNQIAE LINHAI ZHIJIANGCHINAORAL SOLID ORDINARY TABLETS1.0X60.0 TABLET CONTAINER1/7/2011
1291NDA/MAL/HDP/3200LABORATORY AND ALLIED LTDHARLEYS UGANDA LIMITEDLETRAXLEVAMISOLE HYDROCHLORIDE40MGLABORATORY & 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 CONTAINER,1.0X200.0 TABLET CONTAINER,1.0X25.0X3.0 TABLET BLISTER,1.0X3.0 TABLET BLISTER1/7/1997
1292NDA/MAL/HDP/3202IPCA LABORATORIES LTDMEDVIN PHARMA LIMITEDPRESARTAN-50LOSARTAN50MG 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,1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER1/7/2008
1293NDA/MAL/HDP/3203SERUM INSTITUTE OF INDIA LTD.NORVIK ENTERPRISES LIMITEDTETANUS ANTITOXINTETANUS ANTITOXIN1500 I.USERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIA INDIAPARENTERAL ORDINARY AMPOULES1.0X50.0X1.0 ML AMPOULE (1 DOSE AMPOULE)1/7/2013
1294NDA/MAL/HDP/3204GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDRELCER GELALUMINIUM HYDROXIDE/MAGNESIUM HYDROXIDE/DIMETHICONE/LIQUORICE6G+80MG+100MG+400MG/5MLGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D INDIAORAL LIQUID ORDINARY LIQUIDS1.0X180.0 ML BOTTLE,1.0X100.0 ML BOTTLE1/7/2000
1295NDA/MAL/HDP/3207MODI MUNDI PHARMA PVT LTDSURGIPHARM (U) LIMITEDDILCONTIN XL 90CONTROLLED RELEASE TABLETS OF DILTIAZEM HYDROCHLORIDE90MGMODI MUNDIPHARMA (PVT) LTD-MEERUT - MUZAFFARNAGAR ROAD, MODIPURAM, UTTAR PRADESH ESTATE INDIAORAL SOLID RETARD FILM-COATED TABLETS1.0X10.0X10.0 TABLET STRIP1/7/2010
1296NDA/MAL/HDP/3208ACULIFE HEALTHCARE PVT LTDASTRA PHARMA (U) LIMITEDNIRFOL 1%PROPOFOL1%W/VACULIFE HEALTHCARE PVT. LTD-VILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARAT INDIAPARENTERAL ORDINARY VIALS1.0X10.0X1.0X20.0 ML VIAL,1.0X10.0X50.0 ML VIAL1/7/2010
1297NDA/MAL/HDP/3212CIPLA LTD.CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDCLOPRESS 75MGCLOPIDOGREL BISULPHATE75MGCIPLA LIMITED ,.,.-VILLAGE UPPER MALPUR, P.O. BHUD, THE. NALAGARH DISTRICT SOLAN HIMACHAL PRADESH PIN 173205 CIPLA LTD--PLOT NO L-139,VERNA IND ESTATE, VERNA GOA-403 INDIA INDIAORAL SOLID ORDINARY TABLETS10.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER1/7/2005
1298NDA/MAL/HDP/3214MODI MUNDI PHARMA PVT LTDSURGIPHARM (U) LIMITEDINDICONTININDAPAMIDE1.5MGMODI MUNDIPHARMA PVT. LTD-MEERUT-MUZAFFARNAGAR ROAD, MODIPURAM – 250110 UTTAR PRADESH INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER1/7/2010
1299NDA/MAL/HDP/3215CIPLA LTD.CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDSEROCORT 125SALMETEROL XINAFOATE + FLUTICASONE PROPIONATE25MCG + 125MCGCIPLA LTD-CIPLA LTD PLOT NO L-139,VERNA IND ESTATE, VERNA GOA INDIA INDIALUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER1.0X120.0 METERED DOSE CANNISTER1/7/2009
1300NDA/MAL/HDP/3219GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOPHENOL ORAL SUSPENSIONCHLORAMPHENICOL125MG/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 SUSPENSIONS1.0X100.0 ML BOTTLE1/7/1998
1301NDA/MAL/HDP/3220CIPLA LTD.CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDPYLO KITLANSOPRAZOLE+TINIDAZOLE+CLARITHROMYCIN30MG+500MG+250 MGCIPLA LIMITED PUNE-MIDC, KURKUMBH DISTRICT PUNE 413802 INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X7.0X1.0X6.0 TABLET BLISTER (BLISTER CONTAINS 2 CAPSULES AND 4 TABLETS)1/7/2005
1302NDA/MAL/HDP/3221REMINGTON PHARMACEUTICAL INDUS. PVT LTD PAKISTANHEALTHCARE LTD.OPTADEX-N EYE DROPSDEXAMETHASONE/NEOMYCIN1MG/3MGREMINGTON PHARMACEUTICAL INDUS. PVT LTD-, 117 ALLAM PAKISTANOPHTHALMIC DROPS1.0X5.0 ML VIAL1/7/1999
1303NDA/MAL/HDP/3224KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAM FLUFED ELIXIRMULTI-INGREDIENTMULTI-INGREDIENTTIL HEALTHCARE PVT LIMITED-PLOT 100, WEST R-5, SOUTH, SRICITY SEZ, CHERIVE9 (VI), DISTRICT: CHITOOR 517588 ANDHRA PRADESH- INDIAORAL LIQUID ORDINARY LIQUIDS1.0X60.0 ML BOTTLE1/7/1997
1304NDA/MAL/HDP/3225LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDDIFLAMEDICLOFENAC DIETHYLAMINE + LINSEED OIL + METHYL SALICYLATE MENTHOLN/ALINCOLN PHARMACEUTICAL LIMITED-TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIA INDIATOPICAL EXTERNAL GELS AND SOLS1.0X15.0 G TUBE,1.0X30.0 G TUBE1/7/2010
1305NDA/MAL/HDP/3233SHOSAAN ASIC PACIFICRENE PHARMACY LTDWHITFIELD'S OINTMENT BPBENZOIC ACID + SALICYLIC ACID0.06G+0.03GNEM LABORATORIES PVT LTD-PLOT NO. 133 KRISHNA IND. ESTATE, VASAI E,DIST PALGHAR- 401210, MAHARASHTRA STATE INDIATOPICAL EXTERNAL OINTMENTS1.0X20.0 G TUBE1/7/1997
1306NDA/MAL/HDP/3237LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDKONAZOL CREAMKETOCONAZOLE2% W/WLINCOLN PHARMACEUTICAL LIMITED-TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIA INDIATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE1/7/2008
1307NDA/MAL/HDP/3241LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDCLOTRILINCLOTRIMAZOLE1%W/WLINCOLN PHARMACEUTICALS LTD--TRIMUL ESTATE AFER VODSAR VILLAGE KHATJAT 382 721 GUJARAT VADSAR P.O.J TALUKA KALOH DIST GANDHINAGAR INDIAINDIATOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE,1.0X15.0 G TUBE1/7/2008
1308NDA/MAL/HDP/3243MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDRAPITUSLEVODROPROPIZINE30MG/5MLMACLEODS PHARMACEUTICALS LTD -BLOCK N2, VILLAGE THEDA, P.O. LODHI MAJRA, TEHSIL BADDI, DIST. SOLAN, HIMACHAL PRADESH 174101 INDIAORAL LIQUID ORDINARY SYRUPS1.0X120.0 ML BOTTLE
1309NDA/MAL/HDP/3245EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDNYSTATIN ORAL DROPSNYSTATIN100,000 I.U/MLEGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREAEGYPTORAL TOPICAL DROPS1.0X30.0 ML BOTTLE1/7/2013
1310NDA/MAL/HDP/3246GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDCOMPOUND MAGNESIUM TRISILICATEMAGNESIUM TRISILICATE370MGAGOG 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 TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER1/7/2000
1311NDA/MAL/HDP/3248ATCO LABORATORIES LTDHARLEYS UGANDA LIMITEDRUMAFEN GEL 10%IBUPROFEN10%W/WATCO LABS (PVT) LTD-B18 S.I.T.E KARACHI, PAKISTAN PAKISTANORAL TOPICAL UNIT DOSE GELS/SOLS1.0X30.0 G TUBE1/7/2005
1312NDA/MAL/HDP/3249CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDLOSACAR-HLOSARTAN POTASSIUM + HYDROCHLOROTHIAZIDE50MG + 12.5MGCADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER1/7/2004
1313NDA/MAL/HDP/3252GALENTIC PHARMA LTDVITACARE LIMITEDPYLOOCAINBETAMETHASONE + PHENYLEPHRINE + LIDOCAINEO.5 MG/G + 1 MG/G + 25 MG/GGALENTIC PHARMA( INDIA ) PVT LTD-R-673,MIDC TTC RABALE THANE-BELAPUR ROAD,NAVI INDIATOPICAL EXTERNAL OINTMENTS1.0X1.0X30.0 G TUBE1/7/2005
1314NDA/MAL/HDP/3255GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDSATISFIL-50SILDENAFIL CITRATE50MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X1.0X4.0 TABLET BLISTER1/7/2011
1315NDA/MAL/HDP/3259SHOSAAN ASIC PACIFICRENE PHARMACY LTDTIGBODERMBETAMETHASONE + CHLOROCRESOL + GENTAMICIN + CLIOQUINOL + TOLNAFTATE0.05% W/W + 0.1% W/W + 0.1% W/W + 1% W/W + 1% W/WNEM LABORATORIES PVT LTD-PLOT NO. 133 KRISHNA IND. ESTATE, VASAI E,DIST PALGHAR- 401210, MAHARASHTRA STATE INDIATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE1/7/1997
1316NDA/MAL/HDP/3261MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDTENOFOVIR DF + EMTRICITABINE + EFAVIRENZTENOFOVIR DF + EMTRICITABINE + EFAVIRENZ300MG+200MG+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 MYLAN LABORATORIES LIMITED -PLOT NO. 11,12&13 INDORE SPECIAL ECONOMIC ZONE
INDIAORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET BOTTLE1/7/2008
1317NDA/MAL/HDP/3262RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDRENEGELMAGNESIUM HYDROXIDE + ALUMINIUM HYDROXIDE250MG + 250MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA UGANDAORAL SOLID ORDINARY CHEWABLE COATED TABLETS1.0X10.0X10.0 TABLET BLISTER1/7/2007
1318NDA/MAL/HDP/3263REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDTRIMEX MUCOLYTIC SYRUPSALBUTAMOL SULPHATE + BROMHEXINE HYDROCHLORIDE + GUAIFENESIN2MG/5ML + 4MG/5ML + 100MG/5MLREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA KENYAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE1/7/2009
1319NDA/MAL/HDP/3265ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDAMOXICILLINAMOXICILLIN TRIHYDRATE250MGSHIJIAZHUANG PHARMA GROUP, ZHOUGNUO, PHARMACEUTICAL-N0188 GONGNONG ROAD, SHIJIAZHUANG CITY HEBEI PROVINCE, PEOPLE'S REP. CHINA CHINAORAL SOLID ORDINARY CAPSULES1.0X1000.0 CAPSULE CONTAINER1/7/2010
1320NDA/MAL/HDP/3266BETA HEALTHCARE UGANDA LIMITEDBETA HEALTHCARE UGANDA LIMITEDSALIMIA LINIMENTMETHYL SALICYLATE+TURPENTINE OIL5ML+25MLBETA HEALTHCARE INTERNATIONAL LTD - -PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYA KENYATOPICAL EXTERNAL LIQUIDS1.0X60.0 ML BOTTLE,1.0X50.0 ML BOTTLE1/7/1997
1321NDA/MAL/HDP/3270ASTRA PHARMA (UK) LTDASTRA PHARMA (U) LIMITEDFORTIFIED PROCAINE PENICILLINFORTIFIED PROCAINE PENICILLIN4000000 IUCSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG)CO. LTD-NO. 88, YANGZI ROAD, SHIJIAZHUANG CITY, HEBEI PROVINCE(WORKSHOP 406 AND 407) CHINAPARENTERAL ORDINARY DRY VIALS1.0X10.0 VIAL CARTON,1.0X50.0 VIAL CARTON1/7/2001
1322NDA/MAL/HDP/3273KAMPALA PHARMACEUTICAL INDUSTRIES LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDBETASOL CREAMBETAMETHASONE VALERATE0.1%W/WKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALAUGANDATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE,1.0X30.0 G TUBE1/7/1997
1323NDA/MAL/HDP/3275LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDMEFLIN-500MEFENAMIC ACID500MGLINCOLN PHARMACEUTICALS LIMITED -10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER1/7/2010
1324NDA/MAL/HDP/3277HILTON PHARMA (PVT) LTDHEALTHCARE LTD.TRANSAMIN CAPSULES 500MGTRANEXAMIC ACID500MGHILTON PHARMA (PVT) LTD-PLOT 13 SECTOR 15 KORANGI INDUSTRIAL AREA KARACHIPAKISTANORAL SOLID ORDINARY CAPSULES1.0X2.0X10.0 CAPSULE BLISTER1/7/2001
1325NDA/MAL/HDP/3279ROYAL GROUPABACUS PHARMA (AFRICA) LIMITEDHAEMOFORTE SYRUPMULTI-INGREDIENTMULTI-INGREDIENTMILAN LABORATORIES (INDIA ) PVT LTD-PLOT NO 63/67/87 J.C.I.E LTD KAMOTHE PANVER, NAVI MUMBAI,INDIA BAROQUE PHARMACEUTICALS PVT LTD --S.NO.192/2 & S.NO.192/2 &3 SOKHADA-388 620 KHAMBHAT. DIST. ANAND GUJARAT INDIA INDIAORAL LIQUID ORDINARY SYRUPS1.0X90.0 ML BOTTLE,1.0X250.0 ML BOTTLE,1.0X200.0 ML BOTTLE1/7/1997
1326NDA/MAL/HDP/3282MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDKOFF-GOPHENYLEPHRINE HCL + CHLORPHENIRAMINE MALEATE + DEXTROMETHORPHAN5MG/5ML + 2MG/5ML + 10MG/5MLTORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506INDIAORAL LIQUID ORDINARY SYRUPS1.0X1.0X100.0 ML BOTTLE1/7/2009
1327NDA/MAL/HDP/3284LABORATORY&ALLIED LTDHARLEYS UGANDA LIMITEDCHALEATECHLORPHENIRAMINE MALEATE4MGLABORATORY & ALLIED LTD--PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, MOMBASA ROAD P.O. BOX 42875, GPO 00100, NAIROBI, KENYA KENYAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER1/7/1997
1328NDA/MAL/HDP/3285GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDAMOXIL FORTE 250MG/5MLAMOXYCILLIN250MG/5MLGLAXO WELLCOME PRODUCTION.-ZONE INDUSTRIELLE DE LA PEYENNIERE 53100 MAYENNE, FRANCE FRANCEORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE1/7/1997
1329NDA/MAL/HDP/3286CIPLA LIMITEDCIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDLOMAC-20OMEPRAZOLE20 MGCIPLA LTD --PLOT NO 9, 10 & 15, PHARMA ZONE, PHASE II,
SECTOR III, INDORE SPECIAL ECONOMIC ZONE, PITHAMPUR, DIST: DHAR, MADHYA PRADESH – 454 775, INDIA
INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER1/7/2009
1330NDA/MAL/HDP/3288REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDDELASED CHESTY COUGHS SYRUPDIPHENHYDRAMINE HCL BP+AMMONIUM CHLORIDE BP+SODIUM CITRATE BP+MENTHOL BP14MG+135MG+57MG+1.1MG/5MLREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA KENYAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE1/7/1997
1331NDA/MAL/HDP/3289GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDCANDID DUSTING POWDERCLOTRIMAZOLE1%W/WGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D INDIATOPICAL EXTERNAL DUSTING POWDERS1.0X30.0 G BOTTLE,1.0X100.0 G BOTTLE1/7/1999
1332NDA/MAL/HDP/3291GLENMARK PHARMACEUTICALS LTDSTAR PHARMACEUTICALS LTDFINTOPBUTENAFINE HCL1%W/WGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D INDIATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE1/7/2003
1333NDA/MAL/HDP/3292REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDDELASED PAEDIATRIC SYRUPDIPHENHYDRAMINE HYDROCHLORIDE+SODIUM CITRATE+MENTHOL7MG+28.5MG+0.55MGREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA KENYAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE1/7/1997
1334NDA/MAL/HDP/3294WIN-MEDICARE LTDSURGIPHARM (U) LIMITEDURGENDOL CAPSULESTRAMADOL HYDROCHLORIDE50 MGWIN- MEDICARE LTD-MODIPURAM -250 110,UTTAR PRAADESH, INDIA. INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER1/7/2004
1335NDA/MAL/HDP/3295GLENMARK PHARMACEUTICALS LTDSTAR PHARMACEUTICALS LTDGLEVATECLOBETASOL0.05%W/WGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D INDIATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE1/7/2008
1336NDA/MAL/HDP/3296MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIAKIMSY MEDS LTDLOPINAVIR / RITONAVIRLOPINAVIR / RITONAVIR100MG / 25MGMYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE
INDIAORAL SOLID ORDINARY TABLETS1.0X120.0 TABLET CONTAINER,1.0X60.0 TABLET CONTAINER1/7/2011
1337NDA/MAL/HDP/3297LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDNEPIN-SR-20NIFEDIPINE20MGLINCOLN PHARMACEUTICALS LIMITED-10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
INDIAORAL SOLID RETARD FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER1/7/2011
1338NDA/MAL/HDP/3299SEARLE PAKISTAN LIMITEDHEALTHCARE LTD.METODINE-DF SUSPENSIONMETRONIDAZOLE/DILOXANIDE FUROATE200MG/250MGSEARLE PAKISTAN LIMITED-PLOT 35KM, MULTAN ROAD, LAHORE - PAKISTAN PAKISTANORAL LIQUID ORDINARY SUSPENSIONS1.0X60.0 ML BOTTLE1/7/2004
1339NDA/MAL/HDP/3301HILTON PHARMA (PVT) LTDHEALTHCARE LTD.TRANSAMIN CAPSULES 250TRANEXAMIC ACID250MGHILTON PHARMA (PVT) LTD-PLOT 13, SECTOR 15, KORANGI INDUSTRIAL AREA,KARACHI, PAKISTAN. PAKISTANORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER1/7/2000
1340NDA/MAL/HDP/3304REMEDICA LTDGOODMAN INTERNATIONAL LTDFELEXINCEFALEXIN MONOHYDRATE250MGREMEDICA LIMITED -AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUS CYPRUSORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER1/7/2007
1341NDA/MAL/HDP/3309UMEDICA LABORATORIES PVT LTDVITACARE LIMITEDCLORIFORT VAGINAL TABLETSCLOTRIMAZOLE100MGUMEDICA LABORATORIES PVT LTD-PLOT NO. 221, 2ND PHASE, GIDC, VAPI 396195, GUJARAT. INDIA. INDIAVAGINAL TABLETS1.0X6.0 PESSARY STRIP1/7/2002
1342NDA/MAL/HDP/3312TORRENT PHARAMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.TIDOMET FORTECO-CARELDOPA25MG/250MGTORRENT PHARMACEUTICAL LTD-AHMEDABAD-MEHSANA HIGHWAY,TALUKA-KADI,DIST.MEHSANA,INDRAD-382721 INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER1/7/2004
1343NDA/MAL/HDP/3314SUN PHARMACEUTICAL INDUSTRIES LIMITEDSTAR PHARMACEUTICALS LTDSILVEREXSILVER SULFADIAZINE + CHLORHEXIDINE GLUCONATE10MG/G+10MG/GSUN PHARMACEUTICALS IND. LTD-B-2,MADAKAI INDUSTRIAL ESTATE, PONDA,GOA-403404, INDIA INDIATOPICAL EXTERNAL CREAMS1.0X250.0 G TUBE,1.0X25.0 G TUBE,1.0X10.0 G TUBE1/7/2004
1344NDA/MAL/HDP/3315GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDERO-250 TABLETSERYTHROMYCIN STEARATE250MGAGOG 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 CONTAINER1/7/2003
1345NDA/MAL/HDP/3316SPARSH BIO-TECH PVT LTDABACUS PHARMA (AFRICA) LIMITEDSPAMOXAMOXYCILLIN TRIHYDRATE125MG/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 BOTTLE1/7/1998
1346NDA/MAL/HDP/3318RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDRENETRIM TABLETSCO-TRIMOXAZOLE480MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA UGANDAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER1/7/2000
1347NDA/MAL/HDP/3319MEGA LIFESCIENCES (AUSTRALIA) PTY LTDABACUS PHARMA (AFRICA) LIMITEDFERROTONE CAPSULESFERROUS FUMERATE+FOLIC ACID+VITAMIN B12162MG +0.75MG +7.5MCGMEGA LIFESCIENCES LTD.-384 PATTANA 3 ROAD BANGPOO INDUSTRIAL ESTATE SUMUTPRAKANTHAILANDORAL SOLID ORDINARY CAPSULES1.0X5.0X10.0 CAPSULE BLISTER1/7/2005
1348NDA/MAL/HDP/3321LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDDERMOLIN-GMCLOBETASOL+GENTAMICIN+MICONAZOLE0.05%W/W+0.1%W/W+2%W/WLINCOLN PHARMACEUTICALS LIMITED-10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
INDIATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE1/7/2008
1349NDA/MAL/HDP/3328GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDBENZYLPENICILLIN INJECTIONBENZYLPENICILLIN1 MUCSPC ZHONGNUO PHARMACEUTICAL (SCIJIAZHUANG) CO. LTD WORKSHOP -NO. 88 YANGZI ROAD, SHIJIAZHUANG CITY, HEBEI PROVINCE, CHINA WORKSHOP 406 AND 407 CHINAPARENTERAL ORDINARY DRY VIALS1.0X50.0X1.0 MU VIAL,1.0X10.0X1.0 MU VIAL1/7/2001
1350NDA/MAL/HDP/3331NORVATIS PHARMA AG- SWITZERLANDLABOREX UGANDA LIMITEDBETOPTICBETAXOLOLO.5%W/VALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUM BELGIUMOPHTHALMIC DROPS1.0X5.0 ML VIAL1/7/1997
1351NDA/MAL/HDP/3333CIPLA LTD.CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDNOVACLAV-625AMOXICILLIN + CLAVULANATE POTASSIUM500 MG + 125 MGMEDISPRAY LABORATORIES PVT LTD,UNIT II-368-348 KUNDAIM INDUSTRIAL ESTATE,KUNDAIM GOA - 403115,INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X4.0X5.0 TABLET BLISTER1/7/2009
1352NDA/MAL/HDP/3334UNICHEM LABORATORIES LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDMYCLAV 375AMOXICILLIN + CLAVULANIC ACID250 MG + 125 MGUNICHEM LABORATORIES LIMITED UNIT II-VILLAGE BHATAULI KALAN BADDI DIST SOLAN HIMACHAL PRADESH 173 205INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X10.0 TABLET STRIP,1.0X10.0X6.0 TABLET STRIP1/7/2005
1353NDA/MAL/HDP/3341LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDAZILIN-250AZITHROMYCIN250MGLINCOLN PHARMACEUTICALS LIMITED-10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X6.0 TABLET BLISTER1/7/2008
1354NDA/MAL/HDP/3342SEARLE PAKISTAN LTDHEALTHCARE LTD.METODINE DF TABLETSMETRONIDAZOLE+DILOXANIDE400MG+500MGSEARLE PAKISTAN LTD-PLOT F-319, SITE KARACH, 75700 PAKISTAN PAKISTANORAL SOLID ORDINARY SOLUBLE TABLETS1.0X3.0X5.0 TABLET BLISTER1/7/2004
1355NDA/MAL/HDP/3343REGAL PHARMA U LIMITEDREGAL PHARMA (U) LTDMEDIVEN-CREAMBETAMETHASONE VALERATE0.1%W/WREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA KENYATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE1/7/1997
1356NDA/MAL/HDP/3346WOCKHARDT LTDSTAR PHARMACEUTICALS LTDZEDEXBROMHEXINE +AMMONIUM CHLORIDE+ MENTHOL + DEXTROMETHORPHAN8MG+100MG+5MG+10MGWOCKHARDT LIMITED --PLOT 57 VILLAGE KUNJHAL, JHAMAJRI, BAROTIWALA, BADDI, TEHSIL-NALAGARH, DISTRICT SOLAN, 174103 HIMACHAL PRADESH, INDIA INDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE1/7/1997
1357NDA/MAL/HDP/3347REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDUNIPEN TABLETSPHENOXYMETHYLPENICILLIN250MGREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA KENYAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER1/7/1997
1358NDA/MAL/HDP/3348VENUS REMEDIES LTDHARLEYS UGANDA LIMITEDPIMCEFCEFEPIME USP1GVENUS REMEDIES LTD.-UNIT 11 HOLL TOP INDUSTRIAL ESTATE JHARMAJRIINDIAPARENTERAL ORDINARY DRY VIALS1.0X20.0 ML VIAL1/7/2007
1359NDA/MAL/HDP/3354REGAL PHARMA U LIMITEDREGAL PHARMA (U) LTDMEDIVEN OINTMENTBETAMETHASONE VALERATE0.1%W/WREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA KENYATOPICAL EXTERNAL OINTMENTS1.0X15.0 G TUBE1/7/1997
1360NDA/MAL/HDP/3356CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDZYCEL-100 CAPSULESCELECOXIB100MGCADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA INDIAORAL SOLID ORDINARY CAPSULES10.0X10.0 CAPSULE BLISTER1/7/2001
1361NDA/MAL/HDP/3357CENTAUR PHAMACUITICALSGITTOES PHARMACEUTICALS LIMITEDESOREST 20ESOMEPRAZOLE20MGCENTAUR PHARMACEUTICALS PVT L.T.D.-CENTAUR HOUSE NEARINDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER1/7/2008
1362NDA/MAL/HDP/3359SWISS PARENTERALS LTDSHREEJI CARE LIMITEDARTIARTEMETHER80MG/MLSWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIAINDIAPARENTERAL ORDINARY I M AMPOULES1.0X6.0X1.0 ML AMPOULE1/7/2011
1363NDA/MAL/HDP/3364CENTAUR PHAMACUITICALSGITTOES PHARMACEUTICALS LIMITEDESOREST 40ESOMEPRAZOLE40MGCENTAUR PHARMACEUTICALS PVT L.T.D.-CENTAUR HOUSE NEARINDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER1/7/2008
1364NDA/MAL/HDP/3367GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOMOL SUSPENSIONPARACETAMOL125 MG/5MLAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE1/7/2000
1365NDA/MAL/HDP/3368PFIZER LABORATORIES (PTY) LTDLABOREX UGANDA LIMITEDVIAGRA 50MGSILDENAFIL50MGPFIZER PGM -AMBROISE ZONE INDUSTRIELLE 29 ROUTE DES INDUSTRIES 37530 POCE SUR CISSEFRANCEORAL SOLID ORDINARY TABLETS1.0X12.0 TABLET BLISTER,1.0X8.0 TABLET BLISTER,1.0X4.0 TABLET BLISTER1/7/1998
1366NDA/MAL/HDP/3369LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDAZILIN-500AZITHROMYCIN500MGLINCOLN PHARMACEUTICALS LIMITED-10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X3.0 TABLET BLISTER1/7/2008
1367NDA/MAL/HDP/3370RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDDERMOREN 500GRISEOFULVIN500MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA UGANDAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER1/7/2009
1368NDA/MAL/HDP/3372S K AGE EXPORTSABACUS PHARMA (AFRICA) LIMITEDMUCOLEXAMBROXOL HYDROCHLORIDE + SALBUTAMOL SULPHATE + GUAIFENESIN + MENTHOL30 MG/5ML + 1 MG/5ML + 50 MG/5ML + 0.5 MG/5MLS KANT HEALTHCARE LTD-1802-1805 GIDC PHASE III VAPI 396 195INDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE1/7/2014
1369NDA/MAL/HDP/3373UNICHEM LABORATORIES LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDMYCLAV 625AMOXILLICIN/CLAVULANATE500MG/125MGUNICHEM LABORATORIES LIMITED UNIT II-VILLAGE BHATAULI KALAN BADDI DIST SOLAN HIMACHAL PRADESH 173 205INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X7.0 TABLET STRIP,1.0X10.0X6.0 TABLET STRIP1/7/2005
1370NDA/MAL/HDP/3374COSMOS LIMITEDASTRA PHARMA (U) LIMITEDZITHROX 250MGAZITHROMYCIN250MGCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI KENYAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X6.0 TABLET BLISTER1/7/2008
1371NDA/MAL/HDP/3377GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAMILINEAMITRIPTYLINE25 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 TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER1/7/2011
1372NDA/MAL/HDP/3378GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDCHLOZINE TABLETSCHLORPROMAZINE100MGAGOG 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 CONTAINER1/7/2011
1373NDA/MAL/HDP/3379EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDEPIFASIHUMAN CHORIONIC GONADOTROPIN5000I.UEGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREAEGYPTPARENTERAL ORDINARY AMPOULES1.0X2.0 AMPOULE CARTON1/7/2011
1374NDA/MAL/HDP/3382GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOFEN SUSPENSIONIBUPROFEN100MG/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 SUSPENSIONS1.0X1.0X60.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE1/7/2010
1375NDA/MAL/HDP/3383GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDZEPIN-200CARBAMAZEPINE200 MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIAORAL SOLID ORDINARY TABLETS1.0X100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER1/7/2010
1376NDA/MAL/HDP/3384GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDPROXIMEXA 250MGCEFUROXIME AXETIL250MGGLAXOSMITHKLINE UK LTD-HARMIRE RD BARNARD CASTLE DURHAM, DL12DT UNITED UNITED KINGDOMORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X10.0 TABLET BLISTER1/7/2007
1377NDA/MAL/HDP/3385BLUE CROSS LABORATORIES LTDSTAR PHARMACEUTICALS LTDMEFTAL-P-SUSPENSIONMEFENAMIC ACID100MG/5MLBLUE CROSS LABORATORIES LTD-L-17, VERNA INDUSTRIAL ESTATE,VERNA GOA-403722 INDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X60.0 ML BOTTLE1/7/2007
1378NDA/MAL/HDP/3387GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDPROXIMEXA 500MGCEFUROXIME AXETIL500MGGLAXOSMITHKLINE UK LTD-HARMIRE RD BARNARD CASTLE DURHAM, DL12DT UNITED UNITED KINGDOMORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X10.0 TABLET BLISTER1/7/2007
1379NDA/MAL/HDP/3389BAYER PHARMA AGSURGIPHARM (U) LIMITEDCLARINASE REPE TABSLORATADINE + PSEUDOEPHEDRINE5MG + 120MGSCHERING PLOUGH LABO N.V,-INDUSTRY PARK 30, 2220 HEIST OPDENBERG BELGIUM BELGIUMORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X7.0 TABLET BLISTER1/7/2009
1380NDA/MAL/HDP/3390ELYS CHEMICAL INDUSTRIES LTDVELVET PHARMA LIMITEDALUGELALUMINIUM HYDROXIDEL / MAGNESIUM TRISLICATE120MG/250MGELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBI KENYAORAL LIQUID ORDINARY SUSPENSIONS