Drug Register (September 2020)
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/8513BHARGAVA PHYTOLAB PVT. LTDPLANET PHARMACEUTICALS UGANDA LTDMENIPHIBBHARGAVA PHYTOLAB PVT. LTD -E-1216, PHASE – 1, EXTN. GHATAL, BHIWADI INDUSTRIAL AREA, BHIWADI (RAJ.) INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X20.0 TABLET BLISTER01/07/2016
2NDA/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 BOTTLE03/12/2016
3NDA/MAL/HHP/7959BHARGAVA PHYTOLAB PVT. LTDPLANET PHARMACEUTICALS UGANDA LTDTONIPHIBBHARGAVA PHYTOLAB PVT. LTD -E-1216, PHASE – 1, EXTN. GHATAL, BHIWADI INDUSTRIAL AREA, BHIWADI (RAJ.) INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X6.0 TABLET BLISTER01/07/2015
4NDA/MAL/HHP/7958KREMOINT PHARMA PVT.LTDGOOD DAY PHARMACY LIMITEDKOFFENGES(GINGER FLAVOUR)KREMOINT PHARMA PVT LTD - -RAGHAV ESTATE, K.S.S.I.D.C. INDUSTRIAL ESTATE AREA, SHIGGAON ROAD, SAVANUR 581118, DIST: HAVERI, KARNATAKA, INDIA INDIAORAL SOLID ORDINARY LOZENGES1.0X5.0X4.0 LOZENGE BLISTER,1.0X10.0X6.0 LOZENGE BLISTER01/12/2016
5NDA/MAL/HHP/7961KREMOINT PHARMA PVT.LTDGOOD DAY PHARMACY LIMITEDKOFFENGES LOZENGES MINTKREMOINT PHARMA PVT LTD - -RAGHAV ESTATE, K.S.S.I.D.C. INDUSTRIAL ESTATE AREA, SHIGGAON ROAD, SAVANUR 581118, DIST: HAVERI, KARNATAKA, INDIA INDIAORAL SOLID ORDINARY LOZENGES1.0X5.0X4.0 LOZENGE BLISTER,1.0X10.0X6.0 LOZENGE BLISTER01/12/2016
6NDA/MAL/HHP/7931DAR AL DAWA DEVELOPMENT AND INVESTMENT CO. LTDGAMA PHARMACEUTICALS (U) LIMITEDLIBLAB SYRUPDAR AL DAWA DEVELOPMENT AND INVESTMENT CO. LTD,-NA’UR PRINCE HASHEM BIN AL-HUSSEIN STREET, AMMAN, JORDAN. JORDANORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE01/07/2012
7NDA/MAL/HHP/7942MEGA LIFESCIENCES PUBLIC COMPANY LTDABACUS PHARMA (AFRICA) LIMITEDEUGICA FORTDHG PHARMACEUTICALJOINT-STOCK COMPANY (DHG PHARMA)-NO. 288 BIS, NGUYEN VAN CN STREET, AN HOA WARD, NINHKIEN DISTRICT, CAN THO CITY
THAILANDORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER01/07/2016
8NDA/MAL/HHP/5570PANACEA BIOTEC LTDVITACARE LIMITEDSITCOMPANACEA BIOTEC LTD--MALPUR, BADDI, TEHSIL, NALAGARH, DIST. SOLAN HIMACHAL PRADESH – 173 205 INDIAORAL SOLID ORDINARY TABLETS1.0X2.0X7.0 TABLET BLISTER01/07/2013
9NDA/MAL/HHP/7926HOVID BERHADUNITED HEALTHCARE DISTRIBUTORS LTDHOVID GINGKOHOVID BERHAD-121, JALAN TUNKU ABDUL RAHMAN, 30010 IPOH, PERAK, MALAYSIA MALAYSIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2011
10NDA/MAL/HHP/6915GREAT INDIA INDUSTRIAL & PHARAMCEUTICALS LABORATORIESANDYCO PHARMACY (UGANDA) LTDGIPLA GRIPE WATERGREAT INDIA -19 SUN MILL COMPOUNDINDIAORAL LIQUID ORDINARY LIQUIDS1.0X135.0 ML BOTTLE01/07/2014
11NDA/MAL/HHP/7949UNIQUE PHARMACEUTICAL LABORATORIES. (A DIVISION OF J.B. CHEMICALS AND PHARMACEUTICALS LTD)TATA UGANDA LIMITEDZECUF HERBAL COUGH (SUGAR FREE)UNIQUE PHARMACEUTICAL LABORATORIES --PLOT NO. 215-219 AND 304 - 308 G.I.D.C. INDUSTRIAL AREA,PANOLI—394 116,INDIA. INDIAORAL SOLID ORDINARY LOZENGES1.0X2.0X12.0 LOZENGE CONTAINER01/07/2016
12NDA/MAL/HHP/7946SHEBAC PHARMANORVIK ENTERPRISES LIMITEDAPONTISAEROMAC (INDIA) INC-12, MELDI ESTATE, GOTA AHMEDABAD -382481, GUJARAT, INDIA INDIATOPICAL EXTERNAL SPRAYS WITHOUT GAS1.0X150.0 ML BOTTLE01/07/2015
13NDA/MAL/HHP/7960KREMOINT PHARMA PVT.LTDGOOD DAY PHARMACY LIMITEDKOFFENGES(ORANGE FLAVOUR)KREMOINT PHARMA PVT LTD - -RAGHAV ESTATE, K.S.S.I.D.C. INDUSTRIAL ESTATE AREA, SHIGGAON ROAD, SAVANUR 581118, DIST: HAVERI, KARNATAKA, INDIA INDIAORAL SOLID ORDINARY LOZENGES1.0X5.0X4.0 LOZENGE BLISTER,1.0X10.0X6.0 LOZENGE BLISTER01/12/2016
14NDA/MAL/HHP/5534SOUTH EGYPT DRUG INDUSTRIES CO. (SEDICO)WIDE SPECTRUM ENTERPRISES (U) LIMITEDEUCARBONSOUTH EGYPT DRUG INDUSTRIES CO. (SEDICO)-1ST INDUSTRIAL ZONE, 6 OCTOVER CITY, P.O. BOX 43 EGYPTORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2000
15NDA/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 BOTTLE03/12/2016
16NDA/MAL/HHP/6863KREMOINT PHARMA PVT.LTDGOOD DAY PHARMACY LIMITEDKOFFENGES LOZENGES (HONEY & LEMON FLAVOUR)KREMOINT PHARMA PVT LTD - -RAGHAV ESTATE, K.S.S.I.D.C. INDUSTRIAL ESTATE AREA, SHIGGAON ROAD, SAVANUR 581118, DIST: HAVERI, KARNATAKA, INDIA INDIAORAL SOLID ORDINARY LOZENGES1.0X5.0X4.0 LOZENGE BLISTER,1.0X10.0X6.0 LOZENGE BLISTER01/12/2016
17NDA/MAL/HHP/5518MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDPENODEX OINTMENTMEHTA UNANI PHARMACY & CO LTD-INDIAINDIATOPICAL EXTERNAL OINTMENTS1.0X20.0 G CONTAINER01/07/2007
18NDA/MAL/HHP/5519AJANTA PHARMA LTD 31-0ABACUS PHARMA (AFRICA) LIMITEDAPDYL-H, HERBAL COUGH SYRUPSAVERA PHARMACEUTICALS PVT LTD --H-39 & 40, M.I.D.C, WALUJ, AURANGABAD, INDIA. AJANTA PHARMA LTD - -31-0 M.I.D.C. INDUSTRIAL AREA CHIKALTHANA- AURANGABAD 431210 DIST AURANGABAD INDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE01/07/2004
19NDA/MAL/HHP/5532MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDATMANANTHAN COLD RUBMETA UNANI PHARMACY & CO PVT-G 5524, GIDC, LODHIKA METODA, DIST RAJKOT, GUJARATI INDIANASAL TOPICAL LIQUID INHALATIONS1.0X12.0X1.0 G ROD01/07/2009
20NDA/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 BOTTLE01/07/2004
21NDA/MAL/HHP/5547SHURIK LTDSHURIK LTDMENTHOSIL COUGH DROPMEHTA HERBALS PVT LTD-INDIAINDIAORAL SOLID ORDINARY LOZENGES1.0X35.0X2.0 LOZENGE STRIP01/07/2001
22NDA/MAL/HHP/5559SHURIK LTDSHURIK LTDSTAR SKIN OINTMENTMEHTA UNANI PHARMACY & CO LTD-INDIAINDIATOPICAL EXTERNAL OINTMENTS1.0X12.0 G TUBE01/07/2001
23NDA/MAL/HHP/5576SHURIK LTDSHURIK LTDNO SCAR CREAMMETHA UNANI PHARMACY-METHA UNANI PHARMACY G-524 LODHIKA, G.I.D.C METODA INDIATOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE01/07/2007
24NDA/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 INDIAORAL LIQUID ORDINARY SYRUPS1.0X250.0 MG BOTTLE01/07/2016
25NDA/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 BOTTLE03/12/2016
26NDA/MAL/HHP/7929WOCKHARD LTDSTAR PHARMACEUTICALS LTDMANIX HERBAL CAPSULESTIRUPATI LIFESCIENCES-NAHAN ROAD, PAONTA SAHIB, DISTT. SIRMOUR HIMACHAL PRADESH-173025, INDIA INDIAORAL SOLID ORDINARY CAPSULES1.0X2.0X10.0 CAPSULE BLISTER01/07/2015
27NDA/MAL/HHP/7947UNIQUE PHARMACEUTICAL LABORATORIES. (A DIVISION OF J.B. CHEMICALS AND PHARMACEUTICALS LTD)TATA UGANDA LIMITEDZECUF HERBAL COUGH LOZENGES(HONEY LEMON)UNIQUE PHARMACEUTICAL LABORATORIES. -SURVEY NO.101/2 AND 102/1,DAMAN INDUSTRIAL ESTATE, AIRPORT ROAD, KADAIYA, DAMAN-396 210 INDIA INDIAORAL SOLID ORDINARY LOZENGES1.0X5.0X4.0 LOZENGE STRIP01/07/2014
28NDA/MAL/HHP/7950UNIQUE PHARMACEUTICAL LABORATORIES. (A DIVISION OF J.B. CHEMICALS AND PHARMACEUTICALS LTD)TATA UGANDA LIMITEDZECUF HERBAL COUGH LOZENGES(RASPBERRY)UNIQUE PHARMACEUTICAL LABORATORIES. -SURVEY NO.101/2 AND 102/1,DAMAN INDUSTRIAL ESTATE, AIRPORT ROAD, KADAIYA, DAMAN-396 210 INDIA INDIAORAL SOLID ORDINARY LOZENGES1.0X5.0X4.0 LOZENGE STRIP01/07/2014
29NDA/MAL/HHP/7954UNIQUE PHARMACEUTICAL LABORATORIES. (A DIVISION OF J.B. CHEMICALS AND PHARMACEUTICALS LTD)TATA UGANDA LIMITEDZECUF HERBAL COUGH LOZENGES(PINEAPPLE)UNIQUE PHARMACEUTICAL LABORATORIES. -SURVEY NO.101/2 AND 102/1,DAMAN INDUSTRIAL ESTATE, AIRPORT ROAD, KADAIYA, DAMAN-396 210 INDIA INDIAORAL SOLID ORDINARY LOZENGES1.0X5.0X4.0 LOZENGE STRIP01/07/2014
30NDA/MAL/HHP/7962GOOD DAY PHARMACY LIMITEDPLANET PHARMACEUTICALS UGANDA LTDKREMOINT BABY CARE GRIPE WATERKREMOINT PHARMA PVT LTD---B-8 ADDITIONAL AMBERNATH MIDC OPP. ANAND NAGAR POLICE CHECK POST AMBERNATH (E) DIST THANE 421 506INDIAORAL LIQUID ORDINARY LIQUIDS1.0X135.0 ML BOTTLE01/07/2015
31NDA/MAL/HHP/7966BHARGAVA PHYTOLAB PVT LTDPLANET PHARMACEUTICALS UGANDA LTDKIDFLAMEBHARGAVA PHYTOLAB PVT LTD-B-92, SECTOR – 2 , NOIDA – 201301, U.P. ( INDIA) INDIAORAL SOLID ORDINARY TABLETS1.0X4.0X5.0 TABLET BLISTER01/07/2015
32NDA/MAL/HHP/5597CIRON DRUGS & PHARMACEUTICALS PVT LTDRENE PHARMACY LTDTOOCHE DROPSCIRON DRUGS AND PHARMACEUTICALS PVT LTD-N-118 M.I.D.C, TAAPUR,BOISAR,DIST.THANE MAHARASHTRA INDIA INDIAORAL TOPICAL DROPS1.0X10.0 ML BOTTLE01/07/2014
33NDA/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 BLISTER01/07/2016
34NDA/MAL/HHP/7956UNIQUE PHARMACEUTICAL LABORATORIES. (A DIVISION OF J.B. CHEMICALS AND PHARMACEUTICALS LTD)TATA UGANDA LIMITEDZECUF HERBAL (SUGAR FREE)UNIQUE PHARMACEUTICAL LABORATORIES. -SURVEY NO.101/2 AND 102/1,DAMAN INDUSTRIAL ESTATE, AIRPORT ROAD, KADAIYA, DAMAN-396 210 INDIA INDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE01/07/2015
35NDA/MAL/HHP/5618SHURIK LTDSHURIK LTDVYBRANTVITAL CARE-INDIAINDIAORAL SOLID ORDINARY CAPSULES5.0X10.0 CAPSULE BLISTER01/07/2000
36NDA/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 BLISTER01/07/2016
37NDA/MAL/HHP/5500CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDAPTIZOOM SYRUPCHARAK PHARMA PVT LTD,-EVERGREEN INDUSTRIAL ESTATE, SHAUTI MILL LANE, MUMBAI-400011 INDIA INDIAORAL LIQUID ORDINARY SYRUPS1.0X1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE01/07/2000
38NDA/MAL/HHP/5546CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDPAEDRITONE SYRUPCHARAK PHARMA PVT LTD,-EVERGREEN INDUSTRIAL ESTATE, SHAUTI MILL LANE, MUMBAI-400011 INDIA INDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE01/07/2015
39NDA/MAL/HHP/5550CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDGUM TONE GELCHARAK PHARMA PVT LTD,-EVERGREEN INDUSTRIAL ESTATE, SHAUTI MILL LANE, MUMBAI-400011 INDIA INDIAORAL TOPICAL GELS AND SOLS1.0X50.0 G TUBE01/07/2015
40NDA/MAL/HHP/5572CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDVIGOMAX FORTE CHARAK PHARMA PVT LTD-JAURASI ROAD,PAUTI VILLAGE,G.T ROAD,SAMALKHA-132 101 INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X20.0 TABLET BLISTER01/07/2011
41NDA/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 LOZENGES1.0X3.0X4.0 LOZENGE STRIP01/07/2014
42NDA/MAL/HHP/5498AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDFIGURINAJANTA PHARMA LTD 31-0-AJANTA PHARMA LTD 31-0 MIDC INDUSTRIAL AREACHIKALTHANA 431210 DIST AURANGABAD MAHARASHTRAINDIAORAL SOLID ORDINARY CAPSULES1.0X6.0X10.0 CAPSULE BLISTER01/07/2000
43NDA/MAL/HHP/5503ABACUS PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDAMODEX OINTMENTPOOJA DRUGS-POOJA DRUGSINDIATOPICAL EXTERNAL OINTMENTS1.0X25.0 G JAR01/07/2000
44NDA/MAL/HHP/5505VENUS REMIDIES LTDHARLEYS UGANDA LIMITEDAMPUCARE HERBAL OILPLANET HERBS LIFESCIENCES LIMITED -B-4 SARA INDUSTRIAL ESTATE, SELAQUI, DEHRADUN-248197, UTTARKHAND, INDIA INDIATOPICAL EXTERNAL LIQUIDS1.0X50.0 ML BOTTLE01/07/2008
45NDA/MAL/HHP/5528VIRCHOW HEALTHCARE PVT LTDSURGIPHARM (U) LIMITEDAQUAREST288,SIDCO ESTATE-AMBATTUR, CHENNAI 600 098, TAMIL NADU, INDIA INDIAORAL SOLID ORDINARY POWDERS1.0X10.0X765.0 MG SACHET01/07/2009
46NDA/MAL/HHP/5549HIMALAYA DRUG COMPANY.EUROPA HEALTHCARE (U) LTDBONISAN LIQUIDHIMALAYA DRUG COMPANY-27256287 INDIAINDIAORAL LIQUID ORDINARY LIQUIDS1.0X120.0 ML BOTTLE01/07/2000
47NDA/MAL/HHP/5553ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDMENTHOXYL DOUBLE ACTION HERBAL COUGH LOZENGESLEAMARK HEALTHCAREPVT LTD-SARKHEJ-BAVLA HIGHWAY MATODA AHMEDABADINDIAORAL SOLID ORDINARY LOZENGES1.0X10.0X2.0 LOZENGE STRIP,1.0X50.0X2.0 LOZENGE STRIP01/07/2009
48NDA/MAL/HHP/5557BETA HEALTH CARE INTERNATIONAL LTDBETA HEALTHCARE UGANDA LIMITEDNEW BETA GRIPE WATERSYDLER REMEDIES PVT LTD-M-190 MIDC WALUJ AURANGABAD 431136 BETA HEALTHCARE INTERNATIONAL LTD--PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA,NAIROBI,KENYA INDIAORAL LIQUID ORDINARY LIQUIDS1.0X120.0 ML BOTTLE,1.0X100.0 ML BOTTLE01/07/2014
49NDA/MAL/HHP/5561MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDCOLDDROP MEDICATED COUGH DROPSMEHTA HERBALS PVT LTD-AMRUTMANTHAN HOUSE, SADAR,RAJKOT,GUJARAT - 360 001,INDIA, RAJKOT, GUJARAT 360001, INDIA INDIAORAL SOLID ORDINARY LOZENGES1.0X1.0X100.0 LOZENGE CARTON01/07/2009
50NDA/MAL/HHP/5565ABACUS PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDDENTEX TOOTHACEPOOJA DRUGS-POOJA DRUGSINDIATOPICAL EXTERNAL LIQUIDS1.0X5.0 ML BOTTLE01/07/2000
51NDA/MAL/HHP/5571ABACUS PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDDRAGON LIQUID BALMAMRUTANJAN HEALTH CARE LIMITED-PLOT NO 37,38&39, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR VILLAGE, THIRUPORUR TALUK, KANCHEEPURAM DISTRICT 603110, INDIA INDIATOPICAL EXTERNAL OTHER OINTMENTS1.0X10.0 ML CONTAINER,1.0X5.0 ML CONTAINER01/07/2004
52NDA/MAL/HHP/5574AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDNEW PINKOO GRIPE WATERAJANTA PHARMA LIMITED-31-0 MIDC INDUSTRIAL AREA CHIKALTHANA 431210 DIST AURANGABAD MAHARASHTRA STATEINDIAORAL LIQUID ORDINARY LIQUIDS1.0X120.0 ML BOTTLE01/07/2009
53NDA/MAL/HHP/5580MEGA LIFESCIENCES (AUSTRALIA) PTY LTDABACUS PHARMA (AFRICA) LIMITEDEUGICA SYRUPDHG PHARMACEUTICALJOINT-STOCK COMPANY (DHG PHARMA)-NO. 288 BIS, NGUYEN VAN CN STREET, AN HOA WARD, NINHKIEN DISTRICT, CAN THO CITY
VIETNAMORAL LIQUID ORDINARY SYRUPS1.0X60.0 ML BOTTLE01/07/2016
54NDA/MAL/HHP/5593ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDSYDLER GRIPE WATERSYDLER REMEDIES PVT LTD -M-190, M.I.D.C, WALUJ, AURANGABAD 431 136 (M.S), INDIA.

INDIAORAL LIQUID ORDINARY LIQUIDS1.0X120.0 ML BOTTLE01/07/2010
55NDA/MAL/HHP/5613DR. KIM AYURVEDIC PHARMACYJ.P.IMPEX PHARMACY (U) LIMITEDSMOOTH COUGH DROPSDR KIM AYURVEDIC PHARMACY-INDIAINDIAORAL SOLID ORDINARY LOZENGES1.0X100.0X2.0 LOZENGE STRIP01/07/2005
56NDA/MAL/HHP/5620UNIQUE PHARMACEUTICAL LABORATORIESPLANET PHARMACEUTICALS UGANDA LTDZECUF COLD RUBUNIQUE PHARMACEUTICAL LABORATORIES-PLOT NO. 4 PASE IV, GIDC PANOLI -394 116
GUJARAT INDIA
INDIATOPICAL EXTERNAL OINTMENTS1.0X20.0 G CONTAINER01/07/2009
57NDA/MAL/HHP/5623UNIQUE PHARMACEUTICAL LABORATORIESTATA UGANDA LIMITEDZECUF HERBAL COUGH LOZENGES(FRUITY FLAVOUR)UNIQUE PHARMACEUTICAL LABORATORIES. -SURVEY NO.101/2 AND 102/1,DAMAN INDUSTRIAL ESTATE, AIRPORT ROAD, KADAIYA, DAMAN-396 210 INDIA INDIAORAL SOLID ORDINARY LOZENGES1.0X5.0X4.0 LOZENGE STRIP01/07/2005
58NDA/MAL/HHP/5629UNIQUE PHARMACEUTICAL LABORATORIESTATA UGANDA LIMITEDZECUF HERBAL COUGH LOZENGES(ORANGE FLAVOUR)UNIQUE PHARMACEUTICAL LABORATORIES. -SURVEY NO.101/2 AND 102/1,DAMAN INDUSTRIAL ESTATE, AIRPORT ROAD, KADAIYA, DAMAN-396 210 INDIA INDIAORAL SOLID ORDINARY LOZENGES1.0X5.0X4.0 LOZENGE STRIP01/07/2005
59NDA/MAL/HHP/5630UNIQUE PHARMACEUTICAL LABORATORIESTATA UGANDA LIMITEDZECUF HERBAL COUGH REMEDYUNIQUE PHARMACEUTICAL LABORATORIES --PLOT NO. 215-219 AND 304 - 308 G.I.D.C. INDUSTRIAL AREA,PANOLI—394 116,INDIA. INDIAORAL LIQUID ORDINARY LIQUIDS1.0X100.0 ML BOTTLE01/07/2000
60NDA/MAL/HHP/5631UNIQUE PHARMACEUTICAL LABORATORIESTATA UGANDA LIMITEDZECUF HERBAL COUGH LOZENGES(LEMON)UNIQUE PHARMACEUTICAL LABORATORIES. -SURVEY NO.101/2 AND 102/1,DAMAN INDUSTRIAL ESTATE, AIRPORT ROAD, KADAIYA, DAMAN-396 210 INDIA INDIAORAL SOLID ORDINARY LOZENGES1.0X5.0X4.0 LOZENGE STRIP01/07/2014
61NDA/MAL/HHP/5560AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDSTAMINAAJANTA PHARMA LTD-31-0, M.I.D.C. CHIKALTHANA, CHIKALTHANA, AURANGABAD, MAHARASHTRA STATE, INDIA INDIAORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER01/07/2000
62NDA/MAL/HHP/3115SHURIK LTDSHURIK LTDRHINO BALMMEHTA UNANI PHARMACY & CO LTD-INDIAINDIATOPICAL EXTERNAL OINTMENTS1.0X20.0 G CONTAINER,1.0X10.0 G CONTAINER07/11/2018
63NDA/MAL/HHP/7965BHARGAVA PHYTOLAB PVT. LTDPLANET PHARMACEUTICALS UGANDA LTDCO-EXBHARGAVA PHYTOLAB PVT. LTD -E-1216, PHASE – 1, EXTN. GHATAL, BHIWADI INDUSTRIAL AREA, BHIWADI (RAJ.) INDIA INDIAORAL LIQUID ORDINARY LIQUIDS1.0X100.0 ML BOTTLE01/07/2017
64NDA/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 BOTTLE15/01/2019
65NDA/MAL/HHP/8071EVA PHARMAWIDE SPECTRUM ENTERPRISES (U) LIMITEDMOOVE MASSAGE CREAMEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT EGYPTTOPICAL EXTERNAL LOTIONS1.0X1.0X40.0 G TUBE01/07/2017
66NDA/MAL/HHP/8094BHARGAVA PHYTOLAB PVT. LTDPLANET PHARMACEUTICALS UGANDA LTDPOSTORALBHARGAVA PHYTOLAB PVT. LTD -E-1216, PHASE – 1, EXTN. GHATAL, BHIWADI INDUSTRIAL AREA, BHIWADI (RAJ.) INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X2.0X15.0 TABLET BLISTER01/07/2017
67NDA/MAL/HHP/8220AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDNOCOLICAJANTA PHARMA LTD - -31-0 M.I.D.C. INDUSTRIAL AREA CHIKALTHANA- AURANGABAD 431210 DIST AURANGABADINDIAORAL LIQUID ORDINARY LIQUIDS1.0X120.0 ML BOTTLE01/07/2017
68NDA/MAL/HHP/8379CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDM2 TONE TABLET CHARAK PHARMA PVT LTD-INDUSTRIALESTATE, SHAUTI MILL LANE, MUMBAI-400011 INDIAORAL SOLID ORDINARY TABLETS1.0X60.0 TABLET BOTTLE20/09/2017
69NDA/MAL/HHP/8457BHARGAVA PHYTOLAB PVT. LTDPLANET PHARMACEUTICALS UGANDA LTDGASTICA SYRUPBHARGAVA PHYTOLAB PVT.LTD-E-1216 PHASE-1, EXTN. GHATAL,BHIWADI INDUSTRIAL AREA, BHIWADI(RAJ.) INDIA INDIAORAL LIQUID ORDINARY SYRUPS1.0X200.0 ML BOTTLE01/07/2017
70NDA/MAL/HHP/8505CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDLIVOMYN SYRUP CHARAK PHARMA PVT LTD-INDUSTRIALESTATE, SHAUTI MILL LANE, MUMBAI-400011 INDIAORAL LIQUID ORDINARY LIQUIDS1.0X200.0 ML BOTTLE02/02/2018
71NDA/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 BOTTLE02/02/2018
72NDA/MAL/HHP/8507SYDLER REMEDIES PVT LTD M-190ROYAL PHARMA 2011 LIMITEDCUFSOL LOZENGES ORANGESYDLER REMEDIES PVT LTD-M-190 MIDC WALUJ AURANGABAD 431136INDIAORAL SOLID ORDINARY LOZENGES1.0X2.0X50.0 LOZENGE BLISTER02/02/2018
73NDA/MAL/HHP/8508CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDKOFOL SF SYRUP CHARAK PHARMA PVT LTD-INDUSTRIALESTATE, SHAUTI MILL LANE, MUMBAI-400011 INDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE02/02/2018
74NDA/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
75NDA/MAL/HHP/8510BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDFRICKS COUGH SYRUPBLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIAINDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE06/03/2018
76NDA/MAL/HHP/8511BHARGAVA PHYTOLAB PVT. LTDPLANET PHARMACEUTICALS UGANDA LTDTHUNDER-MBHARGAVA PHYTOLAB PVT. LTD -E-1216, PHASE – 1, EXTN. GHATAL, BHIWADI INDUSTRIAL AREA, BHIWADI (RAJ.) INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2017
77NDA/MAL/HHP/8512BHARGAVA PHYTOLAB PVT. LTDPLANET PHARMACEUTICALS UGANDA LTDINFAB SYRUPBHARGAVA PHYTOLAB PVT. LTD -E-1216, PHASE – 1, EXTN. GHATAL, BHIWADI INDUSTRIAL AREA, BHIWADI (RAJ.) INDIA INDIAORAL LIQUID ORDINARY SYRUPS1.0X120.0 ML BOTTLE01/07/2017
78NDA/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
INDIATOPICAL EXTERNAL GELS AND SOLS1.0X10.0 ML TUBE24/11/2017
79NDA/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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JORDANTOPICAL EXTERNAL OINTMENTS1.0X30.0 G TUBE,1.0X15.0 G TUBE13/07/2017
80NDA/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
81NDA/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 BOTTLE01/07/2018
82NDA/MAL/HHP/9093BETA HEALTHCARE UGANDA LIMITEDBETA HEALTHCARE UGANDA LIMITEDCOFTA EXTRA SYRUPBETA HEALTHCARE INTERNATIONAL LTD -PLOT NO LR 209/6534 MOGADISHU ROADKENYAORAL LIQUID ORDINARY LIQUIDS1.0X100.0 ML BOTTLE22/03/2019
83NDA/MAL/HHP/9094BETA HEALTHCARE UGANDA LIMITEDBETA HEALTHCARE UGANDA LIMITEDBETASIL HERBAL COUGH SYSRUPBETA HEALTHCARE INTERNATIONAL LTD -PLOT NO LR 209/6534 MOGADISHU ROADKENYAORAL LIQUID ORDINARY LIQUIDS1.0X100.0 ML BOTTLE22/03/2019
84NDA/MAL/HHP/9115NZEN ENTERPRISEHEALTHCARE LTD.DO-MO CAPSULES ABARIS HEALTHCARE PVT. LTD-SURVEY NO. 1407/11, VILLAGE RAJPUR, TAL KADI DIST. MEHSANA, GUJARAT-382740 INDIAORAL SOLID ORDINARY CAPSULES1.0X4.0X10.0 CAPSULE BLISTER16/07/2019
85NDA/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 CARTON11/03/2020
86NDA/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 BOTTLE11/03/2020
87NDA/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 BOTTLE11/03/2020
88NDA/MAL/HHP/9124HINUCONBOOTS PHARMACEUTICALS LIMITEDINSTUM QUICK MELT SACHET (ORANGE FLAVOUR)HINUCON -PLOT NO.12/1 SECTOR 15,KORANGI INDUSTRIAL AREA, KARACHI 9TH FLOOR PROGRESSIVE PLAZA,BEAUMONT ROAD,KARACHI,PAKISTAN PAKISTANORAL LIQUID ORDINARY SOLUBLE POWDERS1.0X12.0X5.0 SACHET CARTON11/03/2020
89NDA/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 CARTON11/03/2020
90NDA/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 BOTTLE11/03/2020
91NDA/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 JAR11/03/2020
92NDA/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 BOTTLE11/03/2020
93NDA/MAL/HHP/9170SMC ECOPHARMYURIA PHARM EAST AFRICA LIMITEDPROTEFLAZIDPHARMEX GROUP LLC100 -SHEVCHENKA STR., BORYSPIL, KYIV REGION, 08300, UKRAINE UKRAINERECTAL SYSTEMIC SUPPOSITORIES1.0X2.0X5.0 SUPPOSITORY BLISTER11/12/2019
94NDA/MAL/HHP/9171SMC ECOPHARMYURIA PHARM EAST AFRICA LIMITEDPROTEFLAZID DROPSPHARMEX GROUP LLC100 -SHEVCHENKA STR., BORYSPIL, KYIV REGION, 08300, UKRAINE UKRAINEVAGINAL LIQUIDS1.0X30.0 ML BOTTLE11/12/2019
95NDA/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 BLISTER29/01/2020
96NDA/MAL/HHP/9181REDDYS PHARMA LIMITEDREDDYS PHARMA LIMITEDZEBAGREAT INDIA INDUSTRIAL AND PHARMACEUTICAL LABORATORIES-19,SUN MILLS COMPD,MUMBAI 400 013 INDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE,1.0X120.0 ML BOTTLE,1.0X135.0 ML BOTTLE11/03/2020
97NDA/MAL/HHP/9182NZEN ENTERPRISEHEALTHCARE 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 BOTTLE11/03/2020
98NDA/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 BLISTER22/05/2020
99NDA/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 BLISTER22/05/2020
100NDA/MAL/HHP/9254UNIQUE PHARMACEUTICALS LABORATORIESTATA UGANDA LIMITEDZECUF 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 STRIP18/07/2020
101NDA/MAL/HHP/9330ECHO PHARMACYECHO PHARMACY (U) LIMITEDHEMOZEL CREAMALFA MANUFACTURING LLC-4701 NW. 77 AVENUE,MIAMI,FL 33166 UNITED STATESTOPICAL EXTERNAL CREAMS1.0X40.0 G TUBE07/08/2020
102NDA/MAL/HHP/7934STAR PHARMACEUTICALS LTDSTAR PHARMACEUTICALS LTDSENSUR RUBEFACIENTGLENMARK PHARMACEUTICAL LIMITED-61-62 COMPOUND, DEWAS NAKA, LASUDIA MORI INDIATOPICAL EXTERNAL OINTMENTS1.0X30.0 G TUBE01/07/2015
103NDA/MAL/HHP/7937GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDSENSUR OILGLENMARK PHARMACEUTICAL LIMITED-61-62 COMPOUND, DEWAS NAKA, LASUDIA MORI INDIATOPICAL EXTERNAL LIQUIDS1.0X10.0 ML VIAL01/07/2015
104NDA/MAL/HHP/7940GLENMARK PHARMACEUTICALS LTDSTAR PHARMACEUTICALS LTDSENSUR LOTIONGLENMARK PHARMACEUTICAL LIMITED-61-62 COMPOUND, DEWAS NAKA, LASUDIA MORI INDIATOPICAL EXTERNAL OTHER CREAMS1.0X50.0 ML BOTTLE01/07/2015
S/NNDA REGISTRATION NUMBERLICENSE HOLDERLOCAL TECHNICAL REPRESENTATIVENAME OF DRUGMANUFACTURERCOUNTRY OF MANUFACTUREDOSAGE FORMPACK SIZEREGISTRATION DATE
1NDA/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/6348ABARIS HEALTHCARE PVT. LTDROYAL PHARMA 2011 LIMITEDCOMPOUND SODIUM LACTATE INTRAVENOUS INFUSION BPSODIUM LACTATE SOLUTION +SODIUM CHLORIDE + CALCIUM CHLORIDE + POTASSIUM CHLORIDE0.533 GM +0.600 GM + 0.027G+ 0.040 GM/100ML ABARIS HEALTHCARE PVT. LTD--PLOT NO: 1407-1411 VILLAGE: RAJPUR TALUKA: KADI, DIST.: MEHSANA 382 740, GUJARAT INDIA INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X500.0 ML BOTTLE28/03/2018
2NDA/MAL/HDP/6389ABARIS HEALTHCARE PVT. LTDROYAL PHARMA 2011 LIMITEDMETRONIDAZOLE BPMETRONIDAZOLE0.5%W/V ABARIS HEALTHCARE PVT. LTD--PLOT NO: 1407-1411 VILLAGE: RAJPUR TALUKA: KADI, DIST.: MEHSANA 382 740, GUJARAT INDIA INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X100.0 ML BOTTLE28/03/2018
3NDA/MAL/HDP/6426ABARIS HEALTHCARE PVT. LTDROYAL PHARMA 2011 LIMITEDSODIUM CHLORIDE INTRAVENOUS INFUSION BPSODIUM CHLORIDE0.9%W/V ABARIS HEALTHCARE PVT. LTD--PLOT NO: 1407-1411 VILLAGE: RAJPUR TALUKA: KADI, DIST.: MEHSANA 382 740, GUJARAT INDIA INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X500.0 ML BOTTLE01/07/2017
4NDA/MAL/HDP/6456ABARIS HEALTHCARE PVT. LTDROYAL PHARMA 2011 LIMITEDGLUCOSE INTRAVENOUS INFUSION BP (5% W/V)GLUCOSE ANHYDROUS5%W/V ABARIS HEALTHCARE PVT. LTD--PLOT NO: 1407-1411 VILLAGE: RAJPUR TALUKA: KADI, DIST.: MEHSANA 382 740, GUJARAT INDIA INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X500.0 ML BOTTLE01/07/2017
5NDA/MAL/HDP/7234ABARIS HEALTHCARE PVT. LTDROYAL PHARMA 2011 LIMITEDLEVOFLOXACIN INTRAVENOUS INFUSIONLEVOFLOXACIN HEMIHYDRATE + GLUCOSE ANHYDROUS500MG + 5W/V% ABARIS HEALTHCARE PVT. LTD-SURVEY NO. 1407/11, VILLAGE RAJPUR, TAL KADI DIST. MEHSANA, GUJARAT-382740 INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X100.0 ML BOTTLE28/08/2019
6NDA/MAL/HDP/8396MARIE STOPES INTERNATIONALMARIE STOPES UGANDA LIMITEDBACK-UPLEVONORGESTREL1.5MGACME FORMULATION PVT LTD.- ROPAR ROAD NALAGARH DIST SOLAN (H.P) -174 101INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0 TABLET BLISTER29/11/2017
7NDA/MAL/HDP/6369I CARE PHARMA LIMITEDAIVEEN (U) LIMITEDAIVXIM SUSPENSIONCEFIXIME TRIHYDRATE100MG/5ML ASSOCIATED BIOTECH-VILLAGE : KISHANPURA,
GURU MAJRA, BADDI,
DISTT. SOLAN,
INDIA.
INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X60.0 ML BOTTLE31/01/2018
8NDA/MAL/HDP/3011ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDGYNESTCLOTRIMAZOLE100MG ASTRA LIFE CARE (INDIA) PVT-PLOT 57 ROJADA382220, BAVLA AHMEDABAD INDIA INDIAVAGINAL TABLETS1.0X6.0 TABLET BLISTER01/07/2008
9NDA/MAL/HDP/4682AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDLAMIVUDINELAMIVUDINE10MG/ML AUROBINDO PHARMA LIMITED-UNIT – III-SURVEY NO.:313 & 314,BACHUPALLY (VILLAGE)QUTHUBULLAPUR MANDAL, RANGA REDDY DISTRICT, TELANGANA STATE.INDIA. INDIAORAL LIQUID ORDINARY SYRUPS1.0X240.0 ML BOTTLE01/07/2006
10NDA/MAL/HDP/6239BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDGSUNATEARTESUNATE60MGBLISS GVS PHARMA LTD- PLOT 73 -76 SILVER INDUSTRIAL ESTATE BHIMPORE DAMAN 396 210 (UT)INDIAPARENTERAL ORDINARY DRY VIALS1.0X60.0 MG VIAL + 1*5 ML AMPOULE OF 0.9%W/V NACL + 1*1 ML OF 5%W/V SODIUM BICARBONATE01/07/2016
11NDA/MAL/HDP/7071CIPLA LTD.QUALITY CHEMICALS LTD - HUMANFORACORT-200FORMOTEROL FUMARATE DIHYDRATE + BUDESONIDE6MCG + 200MCG CIPLA LIMITED-PLOT NO 9 & 10, PHARMA ZONE, PHASE II, INDORE SPECIAL
ECONOMIC ZONE, PITHAMPUR, DIST: DHAR, MADHYA PRADESH – 454 775, INDIA.
INDIALUNG ADMINISTRATION METERED-DOSE POWDER INHALER1.0X1.0X120.0 METERED DOSE CANNISTER25/07/2018
12NDA/MAL/HDP/7074CIPLA LTDQUALITY CHEMICALS LTD - HUMANFORACORT-100FORMETEROL FUMARATE DIHYDRATE + BUDESONIDE6 MCG+100 MCG CIPLA LIMITED-PLOT NO 9 & 10, PHARMA ZONE, PHASE II, INDORE SPECIAL
ECONOMIC ZONE, PITHAMPUR, DIST: DHAR, MADHYA PRADESH – 454 775, INDIA.
INDIALUNG ADMINISTRATION METERED-DOSE POWDER INHALER1.0X1.0X120.0 METERED DOSE CANNISTER25/07/2018
13NDA/MAL/HDP/7077CIPLA LTDQUALITY CHEMICALS LTD - HUMANFORACORT-400FORMOTEROL FUMARATE DIHYDRATE + BUDESONIDE6MCG + 400MCG CIPLA LIMITED-PLOT NO 9 & 10, PHARMA ZONE, PHASE II, INDORE SPECIAL
ECONOMIC ZONE, PITHAMPUR, DIST: DHAR, MADHYA PRADESH – 454 775, INDIA.
INDIALUNG ADMINISTRATION METERED-DOSE POWDER INHALER1.0X1.0X120.0 METERED DOSE CANNISTER25/07/2018
14NDA/MAL/HDP/7157CIPLA LTD.QUALITY CHEMICALS LTD - HUMANLINEZOLID TABLETS 600MGLINEZOLID600MG CIPLA LIMITED-PLOT NO 9 & 10, PHARMA ZONE, PHASE II, INDORE SPECIAL
ECONOMIC ZONE, PITHAMPUR, DIST: DHAR, MADHYA PRADESH – 454 775, INDIA.
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X10.0 TABLET BOTTLE,1.0X20.0 TABLET CONTAINER31/01/2018
15NDA/MAL/HDP/2679CIPLA LTD.QUALITY CHEMICALS LTD - HUMANALERID 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 BOTTLE01/07/2006
16NDA/MAL/HDP/7127CIPLA LTD.QUALITY CHEMICALS LTD - HUMANCASPOGIN 50CASPOFUNGIN ACETATE50MG CIPLA LTD-UNIT IX, M-61, M-62 & M-63,
VERNA INDUSTRIAL ESTATE,
VERNA, SALCETTE
GOA 403 722
INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0 VIAL CARTON07/11/2018
17NDA/MAL/HDP/7132CIPLA LTD.QUALITY CHEMICALS LTD - HUMANCASPOGIN 70CASPOFUNGIN ACETATE70MG CIPLA LTD-UNIT IX, M-61, M-62 & M-63,
VERNA INDUSTRIAL ESTATE,
VERNA, SALCETTE
GOA 403 722
INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0 VIAL CARTON07/11/2018
18NDA/MAL/HDP/6833DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDON.SENTRON-DENK 8MG ODTONDANSETRON8MGDENK PHARMA GMBH & CO. KG -GOLLSTR. 1 84529 TITTMONINGGERMANYORAL SOLID ORDINARY SOLUBLE TABLETS1.0X6.0 TABLET BLISTER01/07/2016
19NDA/MAL/HDP/8145DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDDENK- AIR 10MONTELUKAST SODIUM10MGDENK PHARMA GMBH & CO. KG -GOLLSTR. 1 84529 TITTMONINGGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X14.0 TABLET BLISTER01/07/2017
20NDA/MAL/HDP/8146DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDDENK- AIR JUNIOR 4MONTELUKAST SODIUM4MGDENK PHARMA GMBH & CO. KG -GOLLSTR. 1 84529 TITTMONINGGERMANYORAL SOLID ORDINARY CHEWABLE TABLETS1.0X2.0X14.0 TABLET BLISTER01/07/2017
21NDA/MAL/HDP/8147DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDDENK- AIR JUNIOR 5MONTELUKAST SODIUM5 MGDENK PHARMA GMBH & CO. KG -GOLLSTR. 1 84529 TITTMONINGGERMANYORAL SOLID ORDINARY CHEWABLE TABLETS1.0X2.0X14.0 TABLET BLISTER01/07/2017
22NDA/MAL/HDP/0816DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDGLIMEPIRIDE DENK 2GLIMEPIRIDE2MGDENK PHARMA GMBH & CO. KG -GOLLSTR. 1 84529 TITTMONINGGERMANYORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2012
23NDA/MAL/HDP/0821DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDGLIMEPIRIDE DENK 3GLIMEPIRIDE3MGDENK PHARMA GMBH & CO. KG -GOLLSTR. 1 84529 TITTMONINGGERMANYORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2012
24NDA/MAL/HDP/6179DENK PHARMA GMBH & CO KGBENLE CONSULT LIMITEDON.SETRON-DENK 4MG ODTONDANSENTRON4MGDENK PHARMA GMBH & CO. KG -GOLLSTR. 1 84529 TITTMONINGGERMANYORAL SOLID ORDINARY SOLUBLE TABLETS1.0X6.0 TABLET BLISTER01/07/2016
25NDA/MAL/HDP/6185DENK PHARMA GMBH & CO KGBENLE CONSULT LIMITEDDOLOFORTE DENKTRAMADOL HYDROCHLORIDE + PARACETAMOL37.5MG + 325MGDENK PHARMA GMBH & CO. KG -GOLLSTR. 1 84529 TITTMONINGGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X10.0 TABLET BLISTER01/07/2016
26NDA/MAL/HDP/3589DENK PHARMA GMBH & COBENLE CONSULT LIMITEDSIMVA-DENK 20SIMVASTATIN20MGDENK PHARMA GMBH & CO-.GK GOII STR.1 84529 TIHMONINGGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2011
27NDA/MAL/HDP/6075EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDOLOHISTINEOLOPATADINE HYDROCHLORIDE1MG/MLEGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREAEGYPTOPHTHALMIC DROPS1.0X5.0 ML BOTTLE01/07/2017
28NDA/MAL/HDP/6078EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDTIMOLOL MALEATETIMOLOL MALEATE5MG/MLEGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREAEGYPTOPHTHALMIC DROPS1.0X5.0 ML BOTTLE01/07/2017
29NDA/MAL/HDP/7686EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDOPTIGENT EYE/EAR DROPSGENTAMICIN SULPHATE0.3W/VEGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREAEGYPTOPHTHALMIC DROPS1.0X5.0 ML BOTTLE01/07/2017
30NDA/MAL/HDP/8197EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDAMIKACINAMIKACIN SULPHATE500MG/2MLEGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREAEGYPTPARENTERAL ORDINARY VIALS1.0X2.0 ML VIAL01/07/2017
31NDA/MAL/HDP/2322EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDTREFLUCANFLUCONAZOLE150MGEGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREAEGYPTORAL SOLID ORDINARY CAPSULES1.0X2.0X1.0 CAPSULE STRIP01/07/2007
32NDA/MAL/HDP/1447EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDVITONA PLUSVITAMINS + MINERALSMULTI-INGREDIENTEGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREAEGYPTORAL SOLID ORDINARY CAPSULES1.0X2.0X6.0 CAPSULE BLISTER01/07/2014
33NDA/MAL/HDP/2144EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDEPICOTILTENOXICAM20MGEGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREAEGYPTPARENTERAL ORDINARY VIALS1.0X3.0 VIAL CARTON + 1*3*2ML WFI AMPOULE01/07/2014
34NDA/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 BOTTLE01/07/2013
35NDA/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 CARTON01/07/2011
36NDA/MAL/HDP/3502EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDHYDROCORTISONE SODIUM SUCCINATEHYDROCORTISONE SODIUM SUCCINATE100MGEGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREAEGYPTPARENTERAL ORDINARY DRY VIALS1.0X100.0 MG VIAL + 1*2ML AMPOULE OF WFI01/07/2010
37NDA/MAL/HDP/3781EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDALZENTELALBENDAZOLE20MG/MLEGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREAEGYPTORAL LIQUID ORDINARY SUSPENSIONS1.0X20.0 ML BOTTLE01/07/2014
38NDA/MAL/HDP/3932EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDEPIRAX TABLETSCLIDINIUM BROMIDE + CHLORDIAZEPOXIDE2.5MG + 5MGEGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREAEGYPTORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET STRIP01/07/2008
39NDA/MAL/HDP/4401EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDEPICEPHINCEFTRIAXONE DISODIUM2GEGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREAEGYPTPARENTERAL ORDINARY DRY VIALS1.0X2.0 G VIAL + 2*5 ML OF WFI GLASS AMPOULES01/07/2014
40NDA/MAL/HDP/4413EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDEPICEPHINCEFTRIAXONE1GEGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREAEGYPTPARENTERAL ORDINARY DRY VIALS1.0X1.0 G VIAL + 2 PLASTIC AMPOULES OF WFI01/07/2011
41NDA/MAL/HDP/4417EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDEPICEPHINCEFTRIAXONE SODIUM500MGEGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREAEGYPTPARENTERAL ORDINARY DRY VIALS1.0X0.5 G VIAL + 1*5 ML OF WFI GLASS AMPOULES01/07/2014
42NDA/MAL/HDP/4419EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDEPIGONAL 75HUMAN MENOPAUSAL GONADOTROPHIN75IU/5MLEGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREAEGYPTPARENTERAL ORDINARY VIALS1.0X5.0 ML VIAL + 1 ML AMPOULE 0.9%W/V NACL01/07/2010
43NDA/MAL/HDP/4774EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDFERROFOL VIT-ZFERROUS SULPHATE+FOLIC ACID+ASCORBIC ACID+THIAMINE MONONITRATE+RIBOTLAVINE+PYRIDOXINE HCL+NICOTINAMIDE+ZINC150MG+0.5MG+50MG+2MG+2MG+1MG+10MG+25MGEGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREAEGYPTORAL SOLID ORDINARY CAPSULES1.0X5.0X6.0 CAPSULE BLISTER01/07/2014
44NDA/MAL/HDP/5279EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDDOSINDOXAZOCIN2MGEGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREAEGYPTORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER01/07/2011
45NDA/MAL/HDP/4141SANOFI WINTHROP A.M.OSURGIPHARM (U) LIMITEDEPILIM 200SODIUM VALPROATE200MG FISONS LTD (ALSO KNOWN AS SANOFI-AVENTIS)-RIELL, SPAIN SPAINORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2001
46NDA/MAL/HDP/6583ZIFAM PINNACLE LTDBOOTS PHARMACEUTICALS LIMITEDAZIFAM 500AZITHROMYCIN500 MG FREDUN PHARMACEUTICALS LIMITED-14,15,16, ZORABIAN INDUSTRIAL COMPLEX,VEOOR,PALGHAR (E), DIST: PALGHAR-401 404 INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER28/08/2019
47NDA/MAL/HDP/6584ZIFAM PINNACLE LTDBOOTS PHARMACEUTICALS LIMITEDZIFLODIP 5AMLODIPINE BESYLATE5 MG FREDUN PHARMACEUTICALS LIMITED-14,15,16, ZORABIAN INDUSTRIAL COMPLEX,VEOOR,PALGHAR (E), DIST: PALGHAR-401 404 INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER28/08/2019
48NDA/MAL/HDP/6585ZIFAM PINNACLE PTY. LTD.BOOTS PHARMACEUTICALS LIMITEDZIFLODIP 10AMLODIPINE BESYLATE10 MG FREDUN PHARMACEUTICALS LIMITED-14,15,16, ZORABIAN INDUSTRIAL COMPLEX,VEOOR,PALGHAR (E), DIST: PALGHAR-401 404 INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER28/08/2019
49NDA/MAL/HDP/6981ZIFAM PINNACLE PTY. LTD.BOOTS PHARMACEUTICALS LIMITEDKIT LANZLANSOPRAZOLE + CLARITHROMYCIN + TINIDAZOLE30MG + 250MG + 500MG FREDUN PHARMACEUTICALS LIMITED-14,15,16, ZORABIAN INDUSTRIAL COMPLEX,VEOOR,PALGHAR (E), DIST: PALGHAR-401 404 INDIAORAL SOLID ORDINARY OTHER SPECIAL FORMS1.0X7.0X6.0 TABLET BLISTER PACK HAS BOTH CAPSULES AND TABLETS28/08/2019
50NDA/MAL/HDP/7095PLANET PHARMACEUTICALS UGANDA LTDPLANET PHARMACEUTICALS UGANDA LTDFREMOL EXTRAPARACETAMOL + CAFFEINE500MG + 65MG FREDUN PHARMACEUTICALS LIMITED-14,15,16, ZORABIAN INDUSTRIAL COMPLEX,VEOOR,PALGHAR (E), DIST: PALGHAR-401 404 INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER27/11/2019
51NDA/MAL/HDP/6232FREDUN PHARMACEUTICALS LTDPLANET PHARMACEUTICALS UGANDA LTDH-CURELANSOPRAZOLE + CLARITHROMYCIN + TINIDAZOLE30MG + 250MG + 500MGFREDUN PHARMACEUTICALS LTD-VEOOR PALGHAR ( E ) 401 404INDIAORAL SOLID ORDINARY TABLETS1.0X7.0X6.0 TABLET BLISTER (BLISTER CONTAINS 2CAPSULES OF LANSOPRAZOLE + 2 TABLETS OF CLARITHROMYCIN + 2 TABLETS OF TINIDAZOLE)01/07/2016
52NDA/MAL/HDP/6236MOONLINK PHARMACEUTICALS LTDPLANET PHARMACEUTICALS UGANDA LTDFREMOL ADVANCEPARACETAMOL + IBUPROFEN + CAFFEINE325 MG + 400 MG + 40 MGFREDUN PHARMACEUTICALS LTD-VEOOR PALGHAR ( E ) 401 404INDIAORAL SOLID ORDINARY CAPSULES1.0X40.0X2.0X10.0 CAPSULE BLISTER01/07/2016
53NDA/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 BOTTLE01/07/1997
54NDA/MAL/HDP/6116DENK PHARMA GMBH & CO KGBENLE CONSULT LIMITEDZOLEDRO-DENK 4MG/5MLZOLEDRONIC ACID4MG/5MLHAMELN PHARMACEUTICALS GMBH-LANGES FELD 13 31789 HAMELNGERMANYPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X5.0 ML VIAL01/07/2017
55NDA/MAL/HDP/7671IPCA LABORATORIES LTDMEDVIN PHARMA LIMITEDDICHLOR-25CHLORTHALIDONE25MG IPCA LABORATORIES LTD,PLOT NO. T-139 -SEJAVTA, RATLAM-457 002 (M.P.) INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2017
56NDA/MAL/HDP/3108IPCA LABORATOIES LTDMEDVIN PHARMA LIMITEDZERODOLACECLOFENAC100MG IPCA LABORATORIES LTD,PLOT NO. T-139 -SEJAVTA, RATLAM-457 002 (M.P.) INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER01/07/2005
57NDA/MAL/HDP/1922IPCA LABORATORIES LIMITEDMEDVIN PHARMA LIMITEDAZIFAST-500AZITHROMYCIN500MG IPCA LABORATORIES LTD,PLOT NO. T-139 -SEJAVTA, RATLAM-457 002 (M.P.) INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X3.0 TABLET BLISTER01/07/2007
58NDA/MAL/HDP/3205EAGLEVET UGANDA LIMITEDMEDVIN PHARMA LIMITEDAZIFAST-250AZITHROMYCIN250MG IPCA LABORATORIES LTD,PLOT NO. T-139 -SEJAVTA, RATLAM-457 002 (M.P.) INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X6.0 TABLET BLISTER01/07/2007
59NDA/MAL/HDP/1747IPCA LABORATORIES LTDMEDVIN PHARMA LIMITEDPRESARTAN H 50LOSARTAN POTASSIUM + HYDROCHLOROTHIAZIDE 50MG + 12.5MG IPCA LABORATORIES LTD-PLOT NO. 255/1,
VILLAGE ATHAL,
SILVASSA-396230,
DADRA AND NAGAR HAVELI, INDIA.
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X14.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER01/07/2008
60NDA/MAL/HDP/2271EAGLEVET UGANDA LIMITEDMEDVIN PHARMA LIMITEDARTEMETHER 20MG/LUMEFANTRINE 120MGARTEMETHER + LUMEFANTRINE20MG + 120MG IPCA LABORATORIES LTD-PLOT NO. 255/1,
VILLAGE ATHAL,
SILVASSA-396230,
DADRA AND NAGAR HAVELI, INDIA.
INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X3.0X6.0 TABLET BLISTER,1.0X30.0X18.0 TABLET BLISTER,1.0X30.0X24.0 TABLET BLISTER,1.0X10.0X1.0X6.0 TABLET BLISTER,1.0X10.0X2.0X6.0 TABLET BLISTER,1.0X30.0X12.0 TABLET BLISTER,1.0X30.0X4.0X6.0 TABLET BLISTER,1.0X30.0X3.0X6.0 TABLET BLISTER,1.0X30.0X2.0X6.0 TABLET BLISTER,1.0X30.0X6.0 TABLET BLISTER,1.0X10.0X4.0X6.0 TABLET BLISTER01/07/2010
61NDA/MAL/HDP/2130IPCA LABORATORIESMEDVIN PHARMA LIMITEDZERODOL-CRACECLOFENAC200MG IPCA LABORATORIES LTD-PLOT NO. 255/1,
VILLAGE ATHAL,
SILVASSA-396230,
DADRA AND NAGAR HAVELI, INDIA.
INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2011
62NDA/MAL/HDP/0929IPCA LABORATORIES LTDMEDVIN PHARMA LIMITEDDUOQUINDIHYDROARTEMISININ + PIPERAQUINE PHOSPHATE40MG +320MG IPCA LABORATORIES LTD-PLOT NO. 255/1,
VILLAGE ATHAL,
SILVASSA-396230,
DADRA AND NAGAR HAVELI, INDIA.
INDIAORAL SOLID ORDINARY TABLETS10.0X1.0X9.0 TABLET BLISTER,10.0X1.0X8.0 TABLET BLISTER01/07/2012
63NDA/MAL/HDP/1259IPCA LABORATORIES LTDMEDVIN PHARMA LIMITEDCARDOZ- 6.25CARVEDILOL6.25MG IPCA LABORATORIES LTD-PLOT NO. 255/1,
VILLAGE ATHAL,
SILVASSA-396230,
DADRA AND NAGAR HAVELI, INDIA.
INDIAORAL SOLID ORDINARY TABLETS1.0X2.0X14.0 TABLET BLISTER01/07/2013
64NDA/MAL/HDP/1261IPCA LABORATORIES LTDMEDVIN PHARMA LIMITEDCARDOZ-12.5CARVEDILOL12.5MG IPCA LABORATORIES LTD-PLOT NO. 255/1,
VILLAGE ATHAL,
SILVASSA-396230,
DADRA AND NAGAR HAVELI, INDIA.
INDIAORAL SOLID ORDINARY TABLETS1.0X2.0X14.0 TABLET BLISTER01/07/2013
65NDA/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 BLISTER01/07/2013
66NDA/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 BLISTER01/07/2008
67NDA/MAL/HDP/6118LEBEN LABORATORIES PVT LTDANDYCO PHARMACY (UGANDA) LTDL-TRIM DSSULPHAMETHOXAZOLE + TRIMETHOPRIM800MG + 160MG LEBEN LABORATORIES PVT. LTD-PLOT NO. L-4, PHASE-III, MIDC,
AKOLA– 444 104 (MS).
INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2017
68NDA/MAL/HDP/6374LEBEN LABORATORIES PVT. LTD., INDIAANDYCO PHARMACY (UGANDA) LTDPREDLEB-5 DTPREDNISOLONE5MG LEBEN LABORATORIES PVT. LTD-PLOT NO. L-4, PHASE-III, MIDC,
AKOLA– 444 104 (MS).
INDIAORAL SOLID ORDINARY SOLUBLE TABLETS1.0X10.0X20.0 TABLET BLISTER28/03/2018
69NDA/MAL/HDP/7338LEBEN LABORATORIES PVT.LTDANDYCO PHARMACY (UGANDA) LTDIBUPLUSIBUPROFEN + PARACETAMOL400MG + 325MG LEBEN LABORATORIES PVT. LTD-PLOT NO. L-4, PHASE-III, MIDC,
AKOLA– 444 104 (MS).
INDIAORAL SOLID ORDINARY TABLETS1.0X15.0X2.0X20.0 TABLET BLISTER05/12/2019
70NDA/MAL/HDP/7708LEBEN LABORATORIES PVT.LTDANDYCO PHARMACY (UGANDA) LTDLAMPYKLOX CAPSULESAMPICILLIN TRIHYDRATE+CLOXACILLIN SODIUM250MG+250MG LEBEN LABORATORIES PVT. LTD-PLOT NO. L-4, PHASE-III, MIDC,
AKOLA– 444 104 (MS).
INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER01/07/2017
71NDA/MAL/HDP/0526LEBEN LABORATORIES LTDANDYCO PHARMACY (UGANDA) LTDAMILEB- 25AMITRIPTYLINE25MG LEBEN LABORATORIES PVT. LTD-PLOT NO. L-4, PHASE-III, MIDC,
AKOLA– 444 104 (MS).
INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X20.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER01/07/2014
72NDA/MAL/HDP/4057LEBEN LABORATORIES PVT. LTD., INDIAANDYCO PHARMACY (UGANDA) LTDLAMPYAMPICILLIN250MG LEBEN LABORATORIES PVT. LTD-PLOT NO. L-4, PHASE-III, MIDC,
AKOLA– 444 104 (MS).
INDIAORAL SOLID ORDINARY CAPSULES1.0X1000.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0X10.0 CAPSULE BLISTER01/07/2011
73NDA/MAL/HDP/4379LEBEN LABORATORIES PVT.LTDANDYCO PHARMACY (UGANDA) LTDSINURHONMULTI-INGREDIENT5MG/ 2MG/ 500MG / 30MG LEBEN LABORATORIES PVT. LTD-PLOT NO. L-4, PHASE-III, MIDC,
AKOLA– 444 104 (MS).
INDIAORAL SOLID ORDINARY TABLETS1.0X12.0X40.0 TABLET BLISTER,1.0X1.0X6.0X20.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER01/07/2010
74NDA/MAL/HDP/5381LEBEN LABORATORIES PVT LTDANDYCO PHARMACY (UGANDA) LTDADIFLAM GELDICLOFENAC DIETHYLAMINE1.16%W/W LEBEN LABORATORIES PVT. LTD-PLOT NO. L-4, PHASE-III, MIDC,
AKOLA– 444 104 (MS).
INDIATOPICAL EXTERNAL GELS AND SOLS1.0X30.0 G TUBE01/07/2008
75NDA/MAL/HDP/5454LEBEN LABORATORIES PVT.LTDANDYCO PHARMACY (UGANDA) LTDMOXILEBAMOXICILLIN125MG/5ML LEBEN LABORATORIES PVT. LTD-PLOT NO. L-4, PHASE-III, MIDC,
AKOLA– 444 104 (MS).
INDIAORAL SOLID ORDINARY POWDERS1.0X100.0 ML BOTTLE01/07/2010
76NDA/MAL/HDP/7533ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDASUNATE 60ARTESUNATE60 MG LINCOLN PARENTERAL LIMITED- 11, TRIMUL ESTATE, KHATRAJ, TAL. KALOL,
DIST. GANDHINAGAR,
GUJARAT, INDIA.
INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0 VIAL CARTON + 1*5ML 0.9%W/W SODIUM CHLORIDE SOLUTION AMPOULE + 1*1ML 5.0%W/W SODIUM BICARBONATE SOLUTION AMPOULE26/09/2018
77NDA/MAL/HDP/8359ABACUS PARENTERAL DRUGS LIMITEDABACUS PHARMA (AFRICA) LIMITEDASUNATE 120ARTESUNATE120MG LINCOLN PARENTERAL LIMITED- 11, TRIMUL ESTATE, KHATRAJ, TAL. KALOL,
DIST. GANDHINAGAR,
GUJARAT, INDIA.
INDIAPARENTERAL ORDINARY DRY VIALS1.0X120.0 MG VIAL + 1*10 ML SODIUM CHLORIDE IN GLASS AMPOULE + 1*2 ML SODIUM BICARBONATE IN GLASS AMPOULE29/11/2017
78NDA/MAL/HDP/8822ABACUS PARENTERAL DRUGS LIMITED.ABACUS PHARMA (AFRICA) LIMITEDALIDOLIDOCAINE HYDROCHLORIDE2%W/V LINCOLN PARENTERAL LIMITED- 11, TRIMUL ESTATE, KHATRAJ, TAL. KALOL,
DIST. GANDHINAGAR,
GUJARAT, INDIA.
INDIAPARENTERAL ORDINARY VIALS1.0X1.0X30.0 ML VIAL30/05/2018
79NDA/MAL/HDP/8825LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDLAXALINKLACTULOSE3.35G/5ML LINCOLN PARENTERAL LIMITED- 11, TRIMUL ESTATE, KHATRAJ, TAL. KALOL,
DIST. GANDHINAGAR,
GUJARAT, INDIA.
INDIAORAL LIQUID ORDINARY LIQUIDS1.0X1.0X150.0 ML BOTTLE30/05/2018
80NDA/MAL/HDP/3175M.J.BIOPHARM PVT LTDTATA UGANDA 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 BLISTER01/07/2012
81NDA/MAL/HDP/5066M.J.BIOPHARM PVT LTDTATA UGANDA LIMITEDDEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATE4MG/ML M.J. BIOPHARM PVT. LTD-L-7, M.I.D.C. , TALOJA, DISTRICT RAIGAD - 410 208
NAVI MUMBAI, INDIA
INDIAPARENTERAL ORDINARY AMPOULES1.0X100.0X1.0 ML AMPOULE01/07/2015
82NDA/MAL/HDP/7012MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDMYHEP DVIRDACLATASVIR + SOFOSBUVIR60MG + 400MG MYLAN LABORATORIES LIMITED-F- 4 & F-12, MIDC, MALEGAON,
SINNAR, NASHIK -422 113 MAHARASHTRA, INDIA.
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X28.0 TABLET BOTTLE31/01/2018
83NDA/MAL/HDP/7236MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDMYDEKLA 30.DACLATASVIR DIHYDROCHLORIDE30 MG MYLAN LABORATORIES LIMITED-F- 4 & F-12, MIDC, MALEGAON,
SINNAR, NASHIK -422 113 MAHARASHTRA, INDIA.
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X28.0 TABLET CONTAINER07/11/2018
84NDA/MAL/HDP/8504MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDLEDVIRLEDIPASVIR + SOFOSBUVIR90MG + 400MG MYLAN LABORATORIES LIMITED-F- 4 & F-12, MIDC, MALEGAON,
SINNAR, NASHIK -422 113 MAHARASHTRA, INDIA.
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X28.0 TABLET BOTTLE29/11/2017
85NDA/MAL/HDP/7231NATIONAL HEALTHCARE PVT LTDANDYCO PHARMACY (UGANDA) LTDLIGNAT 2%LIDOCAINE HYDROCHLORIDE2% W/VNATIONAL HEALTHCARE PVT LTD-CHHATAPIPRA 3 BARANEPALPARENTERAL ORDINARY VIALS1.0X30.0 ML VIAL01/07/2017
86NDA/MAL/HDP/8221NATIONAL HEALTHCAREANDYCO PHARMACY (UGANDA) LTDNEMADOLTRAMADOL HYDROCHLORIDE50MG/MLNATIONAL HEALTHCARE PVT LTD-CHHATAPIPRA 3 BARANEPALPARENTERAL ORDINARY AMPOULES1.0X5.0X2.0 ML AMPOULE01/07/2017
87NDA/MAL/HDP/6144NATIONAL HEALTHCAREANDYCO PHARMACY (UGANDA) LTDNIKOPARACETAMOL500MGNATIONAL HEALTHCARE PVT LTD-CHHATAPIPRA 3 BARANEPALORAL SOLID ORDINARY TABLETS1.0X10.0X100.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER01/07/2016
88NDA/MAL/HDP/6166NATIONAL HEALTHCAREANDYCO PHARMACY (UGANDA) LTDGMICINGENTAMICIN SULPHATE0.3%W/VNATIONAL HEALTHCARE PVT LTD-CHHATAPIPRA 3 BARANEPALOPHTHALMIC DROPS1.0X10.0 ML BOTTLE01/07/2016
89NDA/MAL/HDP/6037GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAVITVITAMIN A200,000 IU OLIVE HEALTHCARE-197/2, ATHIYAWAD DABHEL VILLAGE DAMAN 396210 (U.T) INDIAORAL SOLID ORDINARY CAPSULES1.0X30.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE JAR01/07/2017
90NDA/MAL/HDP/3380PHARMEDIC LABORATORIES(PVT) LIMITEDHEALTHCARE LTD.MALASANARTEMETHER80MG/ML PHARMEDIC LABORATORIES (PVT) LTD-16KM, MULTAN ROAD, LAHORE – PAKISTAN PAKISTANPARENTERAL ORDINARY AMPOULES1.0X5.0X1.0 ML AMPOULE01/07/2004
91NDA/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 CONTAINER01/07/2000
92NDA/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 CONTAINER01/07/2005
93NDA/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 BOTTLE01/07/2007
94NDA/MAL/HDP/2680RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDAMPIREN CAPSULESAMPICILLIN TRIHYDRATE250MG RENE INDUSTRIES LTD-680,KAMULI,KIREKA
KAMPALA,UGANDA
UGANDAORAL SOLID ORDINARY CAPSULES1.0X1000.0 CAPSULE CONTAINER01/07/2007
95NDA/MAL/HDP/2681RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDAMOXIRENAMOXICILLIN TRIHYDRATE250MG RENE INDUSTRIES LTD-680,KAMULI,KIREKA
KAMPALA,UGANDA
UGANDAORAL SOLID ORDINARY CAPSULES1.0X1000.0 CAPSULE CONTAINER01/07/2007
96NDA/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 BOTTLE01/07/2007
97NDA/MAL/HDP/3474RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDAMCLOREN DRY SYRUPAMPICILLIN + CLOXACILLIN125MG+125MG/5ML RENE INDUSTRIES LTD-680,KAMULI,KIREKA
KAMPALA,UGANDA
UGANDAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE01/07/2008
98NDA/MAL/HDP/3478RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDDICLORENDICLOFENAC SODIUM BP50MG RENE INDUSTRIES LTD-680,KAMULI,KIREKA
KAMPALA,UGANDA
UGANDAORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2009
99NDA/MAL/HDP/3582RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDSULPHADIMIDINESULPHADIMIDINE500MG RENE INDUSTRIES LTD-680,KAMULI,KIREKA
KAMPALA,UGANDA
UGANDAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER01/07/2009
100NDA/MAL/HDP/3677RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDIBURENIBUPROFEN200MG RENE INDUSTRIES LTD-680,KAMULI,KIREKA
KAMPALA,UGANDA
UGANDAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2008
101NDA/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 TUBE01/07/2009
102NDA/MAL/HDP/6344S KAGE EXPORTSABACUS PHARMA (AFRICA) LIMITEDLACTEASELACTULOSE SOLUTION66.7% W/W S KANT HEALTHCARE LTD-PLOT NO. 1802-1805, G.I.D.C. PHASE III, VAPI 396 195. GUJARAT. INDIAORAL LIQUID ORDINARY LIQUIDS1.0X1.0X100.0 ML BOTTLE26/09/2018
103NDA/MAL/HDP/7128S K AGE EXPORTSABACUS PHARMA (AFRICA) LIMITEDCOTRIKANT-960TRIMETHOPRIM+SULFAMETHOXAZOLE800MG+160MG S KANT HEALTHCARE LTD-PLOT NO. 1802-1805, G.I.D.C. PHASE III, VAPI 396 195. GUJARAT. INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER26/09/2018
104NDA/MAL/HDP/2069SK AGE EXPORTSABACUS PHARMA (AFRICA) LIMITEDSK DERMBETAMETHASONE + CLOTRIMOXAZOLE + GENTAMYCIN0.05%W/W + 1%W/W + 0.1%W/W S KANT HEALTHCARE LTD-PLOT NO. 1802-1805, G.I.D.C. PHASE III, VAPI 396 195. GUJARAT. INDIATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE,1.0X30.0 G TUBE01/07/2010
105NDA/MAL/HDP/6207S K AGE EXPORTSABACUS PHARMA (AFRICA) LIMITEDGO!GELDICLOFENAC DIETHYLAMINE+METHYL SALICYLATE1.16%W/W + 10%W/W S KANT HEALTHCARE LTD-PLOT NO. 1802-1805, G.I.D.C. PHASE III, VAPI 396 195. GUJARAT. INDIATOPICAL EXTERNAL GELS AND SOLS1.0X30.0 G TUBE01/07/2013
106NDA/MAL/HDP/6410S KAGE EXPORTSABACUS PHARMA (AFRICA) LIMITEDERYTHROKANT ES-DSERYTHROMYCIN ETHYL SUCCINATE250MG/5ML S KANT HEALTHCARE LTD-PLOT NO. 1802-1805, G.I.D.C. PHASE III, VAPI 396 195. GUJARAT. INDIAORAL LIQUID ORDINARY OTHER POWDERS/GRANULES1.0X1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE
107NDA/MAL/HDP/1468CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDOCID CAPSULESOMEPRAZOLE20MG S KANT HEALTHCARE LTD-PLOT NO. 1802-1805, G.I.D.C. PHASE III, VAPI 396 195. GUJARAT. CADILA HEALTH CARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA INDIAORAL SOLID RETARD CAPSULES1.0X10.0X10.0 CAPSULE STRIP01/07/1998
108NDA/MAL/HDP/1666SANOFI AVENTISSURGIPHARM (U) LIMITEDAMARYL 1GLIMEPIRIDE1MGSANOFI AVENTIS-2 BOND STREET MIDRAND 1685 SOUTH AFRICASOUTH AFRICAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2005
109NDA/MAL/HDP/6818SANOFI PASTEURLABOREX UGANDA LIMITEDIMOVAX POLIOPOLIO VIRUS; (MAHONEY) TYPE 1- INACTIVE + (MEF-1) TYPE 2- INACTIVE + (SAUKETT) TYPE 3-INACTIVE40 D + 8D + 32 D ANTIGEN UNITS/ 0.5MLSANOFI PASTEUR-MÉRIEUX 69280 MARCY L’ETOILEFRANCEPARENTERAL ORDINARY VIALS1.0X1.0 ML VIAL01/07/2016
110NDA/MAL/HDP/6788SOUTH EGYPT DRUG INDUSTRIES CO. (SEDICO)WIDE SPECTRUM ENTERPRISES (U) LIMITEDROYAL VIT GMULTI-INGREDIENTSMULTI-INGREDIENTS SOUTH EGYPT DRUG INDUSTRIES CO. (SEDICO)-1ST INDUSTRIAL ZONE, S" OF OCTOBER CITY, EGYPT.
PO. BOX 43, OCTOBER CITY. POSTAL CODE NO.12566
EGYPTORAL SOLID ORDINARY CAPSULES1.0X2.0X10.0 CAPSULE BLISTER01/07/2005
111NDA/MAL/HDP/6109SQUARE PHARMACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDMEXLOLOMEFLOXACIN HYDROCHLORIDE0.3%W/VSQUARE PHARMACEUTICALS LTD - DHAKA UNIT KALIAKOIR GAZIPURBANGLADESHOPHTHALMIC DROPS1.0X5.0 ML BOTTLE01/07/2017
112NDA/MAL/HDP/6111SQUARE PHARMACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDMOTIFASTDOMPERIDONE10MGSQUARE PHARMACEUTICALS LTD - DHAKA UNIT KALIAKOIR GAZIPURBANGLADESHORAL SOLID ORDINARY OTHER TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER01/07/2017
113NDA/MAL/HDP/6139SQUARE PHARMACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDSERVIN CAPSULEFERROUS SULPHATE+FOLIC ACID+THIAMINE MONONITRATE+RIBOFLAVIN+PYRIDOXINE HYDROCHLORIDE+NICOTINAMIDE+ASCORBIC ACID150MG+0.5MG+2MG+2MG+1MG+10MG+50MGSQUARE PHARMACEUTICALS LTD - DHAKA UNIT KALIAKOIR GAZIPURBANGLADESHORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X3.0X10.0 CAPSULE BLISTER01/07/2016
114NDA/MAL/HDP/6182SQUARE PHARMACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDALARIDKETOTIFEN FUMARATE0.025%W/VSQUARE PHARMACEUTICALS LTD - DHAKA UNIT KALIAKOIR GAZIPURBANGLADESHOPHTHALMIC DROPS1.0X5.0 ML BOTTLE01/07/2016
115NDA/MAL/HDP/6624SQUARE PHARMACEUTICALS LTD.PABNA UNITGAMA PHARMACEUTICALS (U) LIMITEDCIPROKENCIPROFLOXACIN HYDROCHLORIDE0.3%W/VSQUARE PHARMACEUTICALS LTD - DHAKA UNIT KALIAKOIR GAZIPURBANGLADESHOPHTHALMIC DROPS1.0X5.0 ML BOTTLE01/07/2016
116NDA/MAL/HDP/8343TROIKAA PHARMACEUTICALS LIMITEDABACUS PHARMA (AFRICA) LIMITEDXYKAA EXTEND 1000PARACETAMOL BP(IMMEDIATE RELEASE)+ PARACETAMOL BP(EXTENDED RELEASE)325MG+675MG TROIKAA PHARMACEUTICALS LTD .-SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHAND, INDIA INDIAORAL SOLID RETARD FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER,2.0X10.0 TABLET BLISTER28/11/2019
117NDA/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 VIAL01/07/2012
118NDA/MAL/HDP/0920TROIKAA PHARMACEUTICALS LIMITEDABACUS PHARMA (AFRICA) LIMITEDBUPITROY HEAVYBUPIVACAINE HYDROCHLORIDE5MG/ML TROIKAA PHARMACEUTICALS LTD .-SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHAND, INDIA INDIAPARENTERAL ORDINARY VIALS1.0X5.0X4.0 ML VIAL01/07/2012
119NDA/MAL/HDP/4958TROIKAA PHARMACEUTICALS LIMITEDABACUS PHARMA (AFRICA) LIMITEDBENZOSEDMIDAZOLAM1MG/ML TROIKAA PHARMACEUTICALS LTD .-SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHAND, INDIA INDIAPARENTERAL ORDINARY VIALS1.0X1.0X5.0 ML VIAL01/07/2011
120NDA/MAL/HDP/5316TROIKAA PHARMACEUTICALS LIMITEDABACUS PHARMA (AFRICA) LIMITEDDYNAPARDICLOFENAC SODIUM + PARACETAMOL50MG + 500MG TROIKAA PHARMACEUTICALS LTD .-SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHAND, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2009
121NDA/MAL/HDP/5318TROIKAA PHARMACEUTICALS LIMITEDABACUS PHARMA (AFRICA) LIMITEDDYNAPAR AQ (1ML)DICLOFENAC SODIUM75MG/ML TROIKAA PHARMACEUTICALS LTD .-SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHAND, INDIA INDIAPARENTERAL ORDINARY AMPOULES1.0X5.0X1.0 ML AMPOULE01/07/2009
122NDA/MAL/HDP/6122TROIKAA PHARMACEUTICALS LIMITEDABACUS PHARMA (AFRICA) LIMITEDROCUTROYROCURONIUM BROMIDE10MGTROIKAA PHARMACEUTICALS LTD- SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHANDINDIAPARENTERAL ORDINARY VIALS1.0X5.0 ML VIAL01/07/2017
123NDA/MAL/HDP/0726TROIKAA PHARMACEUTICALS LIMITEDABACUS PHARMA (AFRICA) LIMITEDT DOL RAPIDTRAMADOL HYDROCHLORIDE50MGTROIKAA PHARMACEUTICALS LTD- SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHANDINDIAORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS1.0X10.0X10.0 TABLET STRIP01/07/2014
124NDA/MAL/HDP/0127DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDCORYCARDONIRBESARTAN + HYDROCHLOROTHIAZIDE300MG + 12.5MG ZHEJIANG HUAHAI PHARMACEUTICAL CO. LTD-XUNQIAO, LINHAI, ZHEJIANG PROVINCE 317024 PEOPLES’ REPUBLIC OF CHINA CHINAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2013
125NDA/MAL/HDP/0128DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDCORYCARDONIRBESARTAN + HYDROCHLOROTHIAZIDE150MG + 12.5MG ZHEJIANG HUAHAI PHARMACEUTICAL CO. LTD-XUNQIAO, LINHAI, ZHEJIANG PROVINCE 317024 PEOPLES’ REPUBLIC OF CHINA CHINAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2013
126NDA/MAL/HDP/0152DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDRYCARDON 150IRBESARTAN150MG ZHEJIANG HUAHAI PHARMACEUTICAL CO. LTD-XUNQIAO, LINHAI, ZHEJIANG PROVINCE 317024 PEOPLES’ REPUBLIC OF CHINA DELORBIS PHARMACEUTICALS LTD-17 ATHINON STR., ERGATES INDUSTRIAL AREA, 2643 ERGATES, P.O. BOX 28629, 2081 LEFKOSIA, CYPRUS CHINAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2013
127NDA/MAL/HDP/0153DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDRYCARDON 300IRBESARTAN300MG ZHEJIANG HUAHAI PHARMACEUTICAL CO. LTD-XUNQIAO, LINHAI, ZHEJIANG PROVINCE 317024 PEOPLES’ REPUBLIC OF CHINA DELORBIS PHARMACEUTICALS LTD-17 ATHINON STR., ERGATES INDUSTRIAL AREA, 2643 ERGATES, P.O. BOX 28629, 2081 LEFKOSIA, CYPRUS CHINAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2013
128NDA/MAL/HDP/2394MERCK SHARP & DOHME BVPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDSTOCRINEFAVIRENZ600MG ZHEJIANG HUAHAI PHARMACEUTICAL CO. LTD-XUNQIAO, LINHAI, ZHEJIANG PROVINCE 317024 PEOPLES’ REPUBLIC OF CHINA MERCK SHARP & DOHME B.V-WAARDENWEG 392031 BN, HAARLEM CHINAORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET BOTTLE01/07/2004
129NDA/MAL/HDP/8488ZIM LABORATORIES LTDGITTOES PHARMACEUTICALS LIMITEDCEFRAZ 200CEFIXIME TRIHYDRATE200MG ZIM LABORATORIES LIMITED-B-21122, MIDC AREA,
KALMESHWAR -441 501,
DIST. NAGPUR,INDIA.
INDIAORAL SOLID ORDINARY CAPSULES1.0X1.0X10.0 CAPSULE BLISTER31/01/2018
130NDA/MAL/HDP/6310ZIM LABORATORIES LTDGITTOES PHARMACEUTICALS LIMITEDZIMCOX 100CELECOXIB100MG ZIM LABORATORIES LTD-B-21/22, M.I.D.C. AREA,
KALMESHWAR – 441501,
DIST. NAGPUR,
MAHARASHTRA,
INDIAORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER26/09/2018
131NDA/MAL/HDP/6405ZIM LABORATORIES LTDGITTOES PHARMACEUTICALS LIMITEDCLOPRAZCLOPIDOGREL BISULFATE75MG ZIM LABORATORIES LTD-B-21/22, M.I.D.C. AREA,
KALMESHWAR – 441501,
DIST. NAGPUR,
MAHARASHTRA,
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2017
132NDA/MAL/HDP/6407ZIM LABORATORIES LTDGITTOES PHARMACEUTICALS LIMITEDZIMCOX 200CELECOXIB200 MG ZIM LABORATORIES LTD-B-21/22, M.I.D.C. AREA,
KALMESHWAR – 441501,
DIST. NAGPUR,
MAHARASHTRA,
INDIAORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER29/11/2017
133NDA/MAL/HDP/6442ZIM LABORATORIES LTDROYAL PHARMA 2011 LIMITEDAZITO SUSPENSIONAZITHROMYCIN DIHYDRATE200 MG/5ML ZIM LABORATORIES LTD-B-21/22, M.I.D.C. AREA,
KALMESHWAR – 441501,
DIST. NAGPUR,
MAHARASHTRA,
INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X30.0 ML BOTTLE,1.0X15.0 ML BOTTLE01/07/2018
134NDA/MAL/HDP/6444ZIM LABORATORIES LTDGITTOES PHARMACEUTICALS LIMITEDCEFRAZ 100CEFIXIME TRIHYDRATE100MG ZIM LABORATORIES LTD-B-21/22, M.I.D.C. AREA,
KALMESHWAR – 441501,
DIST. NAGPUR,
MAHARASHTRA,
INDIAORAL SOLID ORDINARY SOLUBLE TABLETS1.0X2.0X10.0 TABLET BLISTER31/01/2018
135NDA/MAL/HDP/7029ZIM LABORATORIES LTDGITTOES PHARMACEUTICALS LIMITEDLIPIZAR 20ATORVASTATIN CALCIUM (TRIHYDRATE)20MG ZIM LABORATORIES LTD-B-21/22, M.I.D.C. AREA,
KALMESHWAR – 441501,
DIST. NAGPUR,
MAHARASHTRA,
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER28/03/2018
136NDA/MAL/HDP/8653PSA INTERNATIONAL (EXPORT DIVISION OF PSA CHEMICALS AND PHARMACEUTICALS PVT. LTD)ROYAL PHARMA 2011 LIMITEDLEFLOXIN 500LEVOFLOXACIN HEMIHYDRATE500MG ZIM LABORATORIES LTD-B-21/22, M.I.D.C. AREA,
KALMESHWAR – 441501,
DIST. NAGPUR,
MAHARASHTRA,
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X10.0 TABLET BLISTER28/03/2018
137NDA/MAL/HDP/8815ZIM LABORATORIES LTDGITTOES PHARMACEUTICALS LIMITEDZIMAGRA – ODS 50SLIDENAFIL CITRATE50 MG ZIM LABORATORIES LTD-B-21/22, M.I.D.C. AREA,
KALMESHWAR – 441501,
DIST. NAGPUR,
MAHARASHTRA,
INDIAOTHER SYSTEMIC SPECIAL SOLIDS1.0X1.0X10.0 SACHET CARTON30/05/2018
138NDA/MAL/HDP/8316AUROBINDOM PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDDOLUTEGRAVIR 50 MG/ LAMIVUDINE 300 MG/ TENOFOVIR DISOPROXIL FUMARATE 300 MG TABLETSDOLUTEGRAVIR SODIUM + LAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE50MG + 300MG + 300MG"AUROBINDO PHARMA LIMITED-UNIT –VII, SEZ, TSIIC, PLOT NO. SI,S. NO.’S 411/P, 425/P, 434/P, 435/P & 458/P,GREEN INDUSTRIAL PARK, POLEPALLY VILLAGE, JEDCHERLA MANDAL,
MAHABOOB NAGAR DISTRICT -509 302
TELANGANA STATE, INDIA"
AUROBINDO PHARMA LTD, UNIT X-NO. 16, APIIC MULTI PRODUCTS SEZ, MENAKUR VILLAGE, NAIDUPETA MANDAL, SPSR, NELLORE DISTRICT, ANDHRA PRADESH, PIN 524421
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X30.0 TABLET BOTTLE30/05/2018
139NDA/MAL/HDP/6293MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDNEUROGAB 150PREGABALIN150MG"MACLEODS PHARMACEUTICALS LTD,--BLOCK N2, VILLAGE THEDA, POST OFFICE LODHIMAJRA, TEHSIL BADDI, DISTRICT SOLAN,
HIMACHAL PRADESH – 174101
INDIA."
INDIAORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER17/12/2018
140NDA/MAL/HDP/9055MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDPYRAZINAMIDE TABLETS BP 150MGPYRAZINAMIDE150MG"MACLEODS PHARMACEUTICALS LTD,--BLOCK N2, VILLAGE THEDA, POST OFFICE LODHIMAJRA, TEHSIL BADDI, DISTRICT SOLAN,
HIMACHAL PRADESH – 174101
INDIA."
INDIAORAL SOLID ORDINARY SOLUBLE TABLETS1.0X100.0 TABLET CONTAINER26/09/2018
141NDA/MAL/HDP/8108MEDIPHARM SALES LIMITEDMEDIPHARM INDUSTRIES (E.A) LTDORSGLUCOSE ANHYDROUS+TRISODIUM CITRATE+SODIUM CHLORIDE+POTASSIUM CHLORIDE6.75G + 1.45G + 1.3G + 0.75G: MEDIPHARM INDUSTRIES LTD-PLOT 65, KAKAJJO ROAD, BWEYOGERERE
POSTAL ADDRESS : P.O.BOX 5917, KAMPALA.
UGANDAORAL LIQUID ORDINARY SOLUBLE POWDERS1.0X10.0X25.0 G SACHET01/07/2017
142NDA/MAL/HDP/0747MEDIPHARM SALES LIMITEDMEDIPHARM INDUSTRIES (E.A) LTDORALYTE ORANGE CO-PACKGLUCOSE ANHYDROUS + SODIUM CHLORIDE + TRISSODIUM CITRATE DEHYDRATE + POTASSIUM CHLORIDE / ZINC SULPHATE13.5G + 2.6G + 2.9G + 1.5G/ SACHET + 27.43MG/5ML: MEDIPHARM INDUSTRIES LTD-PLOT 65, KAKAJJO ROAD, BWEYOGERERE
POSTAL ADDRESS : P.O.BOX 5917, KAMPALA.
UGANDAORAL LIQUID ORDINARY OTHER SOLID SPECIAL FORMS1.0X20.8 G SACHET + 60 ML BOTTLE01/07/2013
143NDA/MAL/HDP/4358A.MENARINI INDUSTRIE FARMACEUTICHE S.R.IPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDLIOTONHEPARIN SODIUM1000I.U/GA. MENARINI MANUFACTURING LOGICTICS AND SERVICES-VIA 3 SETTE SANTI FLORENCE 50131 ITALYITALYTOPICAL EXTERNAL GELS AND SOLS1.0X30.0 G TUBE,1.0X15.0 G TUBE01/07/2016
144NDA/MAL/HDP/8352MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A.PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDKETESSEDEXKETOPROFEN TROMETAMOL50MG/2MLA. MENARINI MANUFACTURING LOGISTICS AND SERVICES S.R.L-VIA SETTE SANTI 3, 50131 FIRENZE ITALYPARENTERAL ORDINARY AMPOULES1.0X1.0 AMPOULE CARTON,1.0X6.0 AMPOULE CARTON,1.0X20.0 AMPOULE CARTON,1.0X5.0 AMPOULE CARTON26/11/2019
145NDA/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 TUBE01/07/2005
146NDA/MAL/HDP/7288MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A.PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDKETESSE FILM COATED TABLETSDEXKETOPROFEN TROMETAMOL25MGA.MENARINI MANUFACTURING LOGISTICS AND SERVICES S.R.I-VIA CAMPO DI PILE 67100 L'AQUILAITALYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X10.0 TABLET BLISTER31/01/2017
147NDA/MAL/HDP/3504MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A.PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDBIFRILZOFENOPRIL30MGA.MENARINI MANUFACTURING LOGISTICS AND SERVICES S.R.I-VIA CAMPO DI PILE 67100 L'AQUILAITALYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X14.0 TABLET BLISTER,1.0X1.0X7.0 TABLET BLISTER01/07/2015
148NDA/MAL/HDP/7656A.MENARINI INDUSTRIE FARMACEUTICHE RIUNITEPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDSPASMOMENOTILONIUM BROMIDE40MGA.MENARINI MANUFACTURING LOGISTICS AND SERVICES S.R.L-VIA CAMPO DI PILE, L’AQUILA (AQ), ITALY ITALYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X15.0 TABLET BLISTER01/07/2017
149NDA/MAL/HDP/6820ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDABBORI EAR DROPSBORIC ACID1.83%W/VABACUS PARENTERAL DRUGS LIMITED-BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA. UGANDAOTIC DROPS1.0X10.0 ML BOTTLE01/07/2017
150NDA/MAL/HDP/7674ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDABLEVOXLEVOFLOXACIN HEMIHYDRATE5G/LABACUS PARENTERAL DRUGS LIMITED-BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA. UGANDAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X100.0 ML BOTTLE01/07/2017
151NDA/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 BOTTLE01/07/2010
152NDA/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 BOTTLE01/07/2012
153NDA/MAL/HDP/1122ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDABCHLOR EAR DROPSCHLORAMPHENICOL5%W/VABACUS PARENTERAL DRUGS LIMITED-BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA. UGANDAOTIC DROPS1.0X10.0 ML VIAL,1.0X5.0 ML VIAL01/07/2013
154NDA/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 BOTTLE01/07/2014
155NDA/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 VIAL01/07/2015
156NDA/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 AMPOULE01/07/2010
157NDA/MAL/HDP/4784ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDD50GLUCOSE INTRAVENOUS INFUSION50%W/VABACUS PARENTERAL DRUGS LIMITED-BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA. UGANDAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X100.0 ML BOTTLE01/07/2011
158NDA/MAL/HDP/4910ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDFLUZOLFLUCONAZOLE200MGABACUS PARENTERAL DRUGS LIMITED-BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA. UGANDAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X100.0 ML BOTTLE01/07/2011
159NDA/MAL/HDP/8816ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDABPARAPARACETAMOL1%W/VABACUS PARENTERAL DRUGS LIMITED-BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA. UGANDAPARENTERAL ORDINARY INFUSION BAGS1.0X1.0X100.0 ML BOTTLE30/05/2018
160NDA/MAL/HDP/8934ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDCYCLO P EYE DROPSCYCLOPENTOLATE HYDROCHLORIDE1.0%W/VABACUS PARENTERAL DRUGS LIMITED-BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA. UGANDAOPHTHALMIC DROPS1.0X1.0X10.0 ML VIAL25/07/2018
161NDA/MAL/HDP/6812ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDNOFLOXNORFLOXACIN0.3%W/VABACUS PARENTERAL DRUGS LIMITED-PLOT 114, BLOCK 191 UGANDAOPHTHALMIC DROPS1.0X10.0 ML BOTTLE01/07/2016
162NDA/MAL/HDP/6815ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDABCROM EYE DROPSSODIUM CROMOGLYCATE2%W/VABACUS PARENTERAL DRUGS LTD.-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE,
MUKONO
UGANDAOPHTHALMIC DROPS1.0X10.0 ML BOTTLE,1.0X5.0 ML BOTTLE01/07/2016
163NDA/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 VIAL01/07/2011
164NDA/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 VIAL01/07/2015
165NDA/MAL/HDP/3411ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDABNAL NASAL DROPSSODIUM CHLORIDE0.9%W/VABACUS PARENTERAL DRUGS LTD.-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE,
MUKONO
UGANDANASAL SYSTEMIC DROPS1.0X10.0 ML VIAL01/07/2011
166NDA/MAL/HDP/3866ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDRLCOMPOUND SODIUM LACTATE INFUSION BP0.6/ 0.25 /0.04 / 0.027 % W/VABACUS PARENTERAL DRUGS LTD.-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE,
MUKONO
UGANDAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X250.0 ML BOTTLE,1.0X500.0 ML BOTTLE01/07/2010
167NDA/MAL/HDP/4702ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDABTOL 20%W/VMANNITOL200MG/MLABACUS PARENTERAL DRUGS LTD.-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE,
MUKONO
UGANDAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X100.0 ML BOTTLE01/07/2011
168NDA/MAL/HDP/4703ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDABGYLMETRONIDAZOLE500MGABACUS PARENTERAL DRUGS LTD.-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE,
MUKONO
UGANDAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X1.0X100.0 ML BOTTLE01/07/2011
169NDA/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 BOTTLE01/07/2011
170NDA/MAL/HDP/0633ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDCIPROCINCIPROFLOXACIN0.3%W/VABACUS PARENTERAL DRUGS LTD-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE,
MUKONO
UGANDAOPHTHALMIC DROPS1.0X10.0 ML VIAL01/07/2013
171NDA/MAL/HDP/0638PHARMACIE BETHELABACUS PARENTERAL DRUGS LIMITEDABLOL-5 EYE DROPSTIMOLOL MALEATE0.5% W/VABACUS PARENTERAL DRUGS LTD-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE,
MUKONO
UGANDAOPHTHALMIC DROPS1.0X10.0 ML VIAL01/07/2013
172NDA/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 VIAL01/07/2013
173NDA/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 BOTTLE01/07/2013
174NDA/MAL/HDP/4030ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDXBETA- NBETAMETHASONE + NEOMYCIN0.1%W/V +0.5%W/VABACUS PARENTERAL DRUGS LTD-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE,
MUKONO
UGANDAOPHTHALMIC DROPS1.0X1.0X10.0 ML VIAL,1.0X5.0 ML VIAL01/07/2011
175NDA/MAL/HDP/4394ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDNSSODIUM CHLORIDE0.9% 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 BOTTLE01/07/2010
176NDA/MAL/HDP/4796ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDDARROWS SOLUTION (HALF STRENGTH)POTASSIUM CHLORIDE+SODIUM CHLORIDE+SODIUM LACTATE0.13%+0.20%+0.30%ABACUS PARENTERAL DRUGS LTD-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE,
MUKONO
UGANDAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X500.0 ML BOTTLE01/07/2011
177NDA/MAL/HDP/7154ABARIS HEALTHCARE PVT. LTDROYAL PHARMA 2011 LIMITEDCIPROFLOXACIN HYDROCHLORIDECIPROFLOXACIN HYDROCHLORIDE2MG/MLABARIS HEALTHCARE PVT LTD - -SURVEY NO. 1407-11, VILLAGE RAJPUR, TALUKA KADI DIST. MEHSANA, GUJARAT-382740 INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X100.0 ML BOTTLE29/11/2017
178NDA/MAL/HDP/5261ABOTT LABORATORIES S.A (PTY) LIMITEDHARLEYS UGANDA LIMITEDENTAMIZOLEDILOXINIDE FUROATE/METRONIDAZOLE250MG/200MGABBOT LABORATORIES (PAKISTAN) LTD-PLOT NO.13 SECTOR 20 KORANG INDUSTRAL AREA, KARACHI PAKISTAN PAKISTANORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2006
179NDA/MAL/HDP/5270ABOTT LABORATORIES S.A (PTY) LIMITEDHARLEYS UGANDA LIMITEDENTAMIZOLE DSDILOXANIDE FUROATE/ METRONIDAZOLE500MG/400MGABBOT LABORATORIES (PAKISTAN) LTD-PLOT NO.13 SECTOR 20 KORANG INDUSTRAL AREA, KARACHI PAKISTAN PAKISTANORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X15.0 TABLET BLISTER01/07/2006
180NDA/MAL/HDP/3744ABBOTT HEALTHCARE PRODUCTS B.V.HARLEYS UGANDA LIMITEDDUPHALAC SOLUTIONLACTULOSE67G/100MLABBOTT BIOLOGICALS B.V -ABBOTT BIOLOGICALS B.V VEERWEG 12 8121 AA OLSTNETHERLANDSORAL LIQUID ORDINARY LIQUIDS1.0X200.0 ML BOTTLE,1.0X10.0X15.0 ML BOTTLE01/07/2001
181NDA/MAL/HDP/5311ABBOTT HEALTHCARE PRODUCTS B.V.HARLEYS UGANDA LIMITEDDUPHASTON TABLETSDYDROGESTERONE10MGABBOTT BIOLOGICALS B.V -ABBOTT BIOLOGICALS B.V VEERWEG 12 8121 AA OLSTNETHERLANDSORAL SOLID ORDINARY FILM-COATED TABLETS1.0X20.0 TABLET BLISTER01/07/2001
182NDA/MAL/HDP/8491MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDCETROTIDE 0.25MGCETRORELIX0.25MGABBOTT BIOLOGICALS B.V VEERWEG -12,NL-8121 AA OLST
THE NETHERLANDS PIERRE FABRE MEDICAMENT -AQUITAINE PHARM INTERNATIONAL SITE 1
FRANCEPARENTERAL ORDINARY COMBINATION PACK VIALS1.0X1.0 VIAL CARTON,1.0X1.0 PREFILLED SYRINGE CARTON31/01/2018
183NDA/MAL/HDP/5266ABOTT LABORATORIES S.A (PTY) LIMITEDHARLEYS UGANDA LIMITEDENTAMIZOLE SUSPENSIONDILOXANIDE FUROATE/ METRONIDAZOLE250MG+200MG/10MLABBOTT LABORATORIES PAKSTAN LTD-PLOT 13, SECTOR 20, KORANGI INDUSTRIAL AREA, KARACHI PAKISTAN. PAKISTANORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE01/07/2006
184NDA/MAL/HDP/0369ABBOT LABORATORIES S.A. (PTY) LTDHARLEYS UGANDA LIMITEDKLACID 250MGCLARITHROMYCIN250MGABBOTT LABORATORIES S.A (PTY) LTD-ABBOTT PLACE,219 GOLF CLUB
TERRACE,CONSTANTIA KLOOF 1709 P.O BOX 7208 WELTEVREDENPARK 1715
SOUTH AFRICAORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER01/07/1998
185NDA/MAL/HDP/0132ABBOT LABORATORIES S.A. (PTY) LTDHARLEYS UGANDA LIMITEDKLACID 500MGCLARITHROMYCIN500MGABBOTT LABORATORIES S.A (PTY) LTD-ABBOTT PLACE,219 GOLF CLUB
TERRACE,CONSTANTIA KLOOF 1709 P.O BOX 7208 WELTEVREDENPARK 1715
SOUTH AFRICAORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER,1.0X14.0 TABLET BLISTER01/07/1998
186NDA/MAL/HDP/0131ABBOT LABORATORIES S.A. (PTY) LTDHARLEYS UGANDA LIMITEDKLACID P125CLARITHROMYCIN125MG/5MLABBOTT LABORATORIES S.A (PTY) LTD-ABBOTT PLACE,219 GOLF CLUB
TERRACE,CONSTANTIA KLOOF 1709 P.O BOX 7208 WELTEVREDENPARK 1715
SOUTH AFRICAORAL LIQUID ORDINARY OTHER POWDERS/GRANULES1.0X50.0 ML BOTTLE,1.0X100.0 ML BOTTLE01/07/1998
187NDA/MAL/HDP/0133ABBOT LABORATORIES S.A. (PTY) LTDHARLEYS UGANDA LIMITEDKLACID P250CLARITHROMYCIN250MG/5MLABBOTT LABORATORIES S.A (PTY) LTD-ABBOTT PLACE,219 GOLF CLUB
TERRACE,CONSTANTIA KLOOF 1709 P.O BOX 7208 WELTEVREDENPARK 1715
SOUTH AFRICAORAL LIQUID ORDINARY OTHER POWDERS/GRANULES1.0X50.0 ML BOTTLE,1.0X100.0 ML BOTTLE01/07/1998
188NDA/MAL/HDP/1661ABBVIE (PTY) LTDMEDICAL ACCESS (UGANDA) LIMITEDALUVIA 100/25LOPINAVIR/ RITONAVIR100MG/25MGABBVIE DEUTSCHLAND GMBH & CO. KG.-KNOLLSTASSE 50, D-67061, LUDWIGSHAFEN, GERMANY. GERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X60.0 TABLET CONTAINER01/07/2007
189NDA/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 BOTTLE01/07/2013
190NDA/MAL/HDP/3831ABBVIE (PTY) LTDMEDICAL ACCESS (UGANDA) LIMITEDALUVIALOPINAVIR+RITONAVIR200MG+50MGABBVIE DEUTSCHLAND GMBH & CO. KG.-KNOLLSTASSE 50, D-67061, LUDWIGSHAFEN, GERMANY. GERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X120.0 TABLET CONTAINER01/07/2007
191NDA/MAL/HDP/6243ABBVIE (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDSURVANTABERACTANT100MG/4MLABBVIE NORTH CHICAGO FACILITY-1401 SHERDAN ROAD NORTH CHICAGO FACILITY ILLINOIS 60064 -4000UNITED STATESTOPICAL EXTERNAL INSTILLATION VIALS1.0X4.0 ML VIAL,1.0X8.0 ML VIAL01/07/2016
192NDA/MAL/HDP/3005ACINO PHARMA AGGOODMAN INTERNATIONAL LTDOLFEN-100 SR DEPOCAPSDICLOFENAC SODIUM100MGACINO PHARMA AG (FORMER MEPHA LLC)-DORNACHERSTRASSE 114 P.O BOX 445 CH4147, AESCH/BL SWITZERLANDORAL SOLID RETARD CAPSULES1.0X10.0 CAPSULE BLISTER01/07/1997
193NDA/MAL/HDP/3686ACINO PHARMA AGGOODMAN INTERNATIONAL LTDNEURORUBINEMULTIVITAMINMULTINGREDIENTACINO PHARMA AG (FORMER MEPHA LLC)-DORNACHERSTRASSE 114 P.O BOX 445 CH4147, AESCH/BL SWITZERLANDORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER01/07/1997
194NDA/MAL/HDP/3492ACINO PHARMA AGGOODMAN INTERNATIONAL LTDOLFEN-50DICLOFENAC SODIUM50MGACINO PHARMA AG -DORNACHERSTRASSE, 114, 4147, AESCH, SWITZERLAND SWITZERLANDORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X10.0 TABLET BLISTER01/07/1997
195NDA/MAL/HDP/4626ACINO PHARMA AGGOODMAN INTERNATIONAL LTDGASEC-20OMEPRAZOLE20MGACINO PHARMA AG -DORNACHERSTRASSE, 114, 4147, AESCH, SWITZERLAND SWITZERLANDORAL SOLID ORDINARY CAPSULES1.0X1.0X14.0 CAPSULE BOTTLE01/07/2005
196NDA/MAL/HDP/2774ACINO PHARMA AGGOODMAN INTERNATIONAL LTDBACTIFLOX NEO 500CIPROFLOXACIN500MGACINO PHARMA AG.-DORNACHERSTRASSE 114, CH-4147 AESCH, SWITZERLAND SWITZERLANDORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER01/07/2005
197NDA/MAL/HDP/2451ACINO PHARMA AGGOODMAN INTERNATIONAL LTDOLFEN 75 SRDICLOFENAC SODIUM75 MGACINO PHARMA AG-DORNACHERSTRASSE 114, CH-4147 AESCH SWITZERLANDORAL SOLID RETARD TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2004
198NDA/MAL/HDP/2455ACINO PHARMA AGGOODMAN INTERNATIONAL LTDARTEQUIN 600/750 LACTABARTESUNATE + MEFLOQUINE200 MG + 250 MGACINO PHARMA AG-DORNACHERSTRASSE 114, CH-4147 AESCH SWITZERLANDORAL SOLID ORDINARY TABLETS1.0X6.0 TABLET BLISTER01/07/2004
199NDA/MAL/HDP/2579ACINO PHARMA AGGOODMAN INTERNATIONAL LTDARTEQUIN 300/375 LACTABARTESUNATE + MEFLOQUINE300 MG + 375 MGACINO PHARMA AG-DORNACHERSTRASSE 114, CH-4147 AESCH SWITZERLANDORAL SOLID ORDINARY TABLETS1.0X6.0 TABLET BLISTER01/07/2005
200NDA/MAL/HDP/3400ACINO PHARMA AGGOODMAN INTERNATIONAL LTDOLFEN GELDICLOFENAC SODIUM1%W/WACINO PHARMA AG-DORNACHERSTRASSE 114, CH-4147 AESCH SOFARIMEX INDUSTRIA QUIMIRA E FARMACEUTICA SA-AV. DAS INDUSTRIAS - ALTO DO COLARIDE, 2735-213 AGUALVA CACEM GERMANYTOPICAL EXTERNAL GELS AND SOLS1.0X50.0 G TUBE,1.0X20.0 G TUBE01/07/1997
201NDA/MAL/HDP/7395PLANET PHARMACEUTICALS (U) LTDPLANET PHARMACEUTICALS UGANDA LTDACE KITMIFEPRISTONE + MISOPROSTOL200MG + 20MCGACME FORMULATION PVT LTD -ROPAR ROAD, NALAGARH DISTT. SOLAN HP-174101 INDIAORAL SOLID ORDINARY TABLETS1.0X5.0 TABLET BLISTER05/12/2019
202NDA/MAL/HDP/4875PHARM ACCESS AFRICA LTDMARIE STOPES UGANDA LIMITEDMISOCLEARMISOPROSTOL200MCGACME FORMULATION PVT LTD,-ACME FORMULATION PVT LTD ROPAR ROAD NALAGARH DIST SOLAN HIMACHAL PRADESH INDIAORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER01/07/2011
203NDA/MAL/HDP/0351MANKIND PHARM LTDTATA UGANDA LIMITEDDEPREGDINALEVONORGESTREL1.5MGACME FORMULATION PVT LTD.-ROPAR ROAD, NALAGARH, DIST. SOLAN, HIMACHAL PRADESH 174101 INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X1.0 TABLET BLISTER01/07/2014
204NDA/MAL/HDP/0010STALLION LABORATORIES PVT LTDSHREEJI PHARMACEUTICALS LIMITED02-LONOFLOXACIN + ORNIDAZOLE200MG + 500MGACME FORMULATION PVT LTD.-ROPAR ROAD, NALAGARH, DIST. SOLAN, HIMACHAL PRADESH 174101 INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2014
205NDA/MAL/HDP/6995STALLION LABORATORIES PVT LTDSHREEJI PHARMACEUTICALS LIMITEDT-MEFTRANEXAMIC ACID + MEFENAMIC ACID250MG + 500MGACME FORMULATION PVT. LTD-ROPAR ROAD, NALAGARH, DIST. SOLAN, HIMACHAL PRADESH 174101 INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER28/08/2019
206NDA/MAL/HDP/6998STALLION LABORATORIES PVT LTDSHREEJI PHARMACEUTICALS LIMITEDL-DIPIN-55LOSARTAN POTASSIUM + AMLODIPINE BESILATE50MG + 5MGACME FORMULATION PVT. LTD-ROPAR ROAD, NALAGARH, DIST. SOLAN, HIMACHAL PRADESH 174101 INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER28/08/2019
207NDA/MAL/HDP/7308STALLION LABORATORIES PVT LTDSHREEJI PHARMACEUTICALS LIMITEDAPSIDASEACECLOFENAC + PARACETAMOL + SERRATIOPEPTIDASE100MG + 500MG + 10MGACME FORMULATION PVT. LTD-ROPAR ROAD, NALAGARH, DIST. SOLAN, HIMACHAL PRADESH 174101 INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER28/08/2019
208NDA/MAL/HDP/7535ACME FORMULATION PVT. LTD.MARIE STOPES UGANDA LIMITEDMARIPRISTMIFEPRISTONE + MISOPROSTOL200MG + 200MCGACME FORMULATION PVT. LTD-ROPAR ROAD, NALAGARH, DIST. SOLAN, HIMACHAL PRADESH 174101 INDIAORAL SOLID ORDINARY TABLETS1.0X1.0X1.0X4.0 TABLET BLISTER28/08/2019
209NDA/MAL/HDP/3102PFIZER LABORATORIES (PTY) LTDLABOREX UGANDA LIMITEDEPANUTIN READY MIXEDPHENYTOIN SODIUM50MG/MLACTAVIS ITALY S.P.A-VIALE PASTEUR, 10 20014 NERVIANO(MILAN) - ITALY ITALYPARENTERAL ORDINARY AMPOULES1.0X5.0X5.0 ML AMPOULE01/07/1997
210NDA/MAL/HDP/7344ACULIFE HEALTHCARELIFE PHARMA AFRICA LIMITEDHEPANIRHEPARIN SODIUM1000IU/MLACULIFE HEALTH CARE, FORMALLY NIRMA(HEALTHCARE DIVISION)-VILLAGE: SACHANA, TALUKA: VIRAMGAM DISTRICT: AHMEDABAD-382150 GUJARAT, INDIA INDIAPARENTERAL ORDINARY VIALS1.0X5.0 ML VIAL29/11/2017
211NDA/MAL/HDP/1716NIRMA LIMITED (HEALTHCARE DI VISION) NIRLIFE HEALTHCARELIFE PHARMA AFRICA LIMITEDNIRMIN 5SMULTI-INGREDIENTMULTI-INGREDIENTACULIFE HEALTH CARE, FORMALLY NIRMA(HEALTHCARE DIVISION)-VILLAGE: SACHANA, TALUKA: VIRAMGAM DISTRICT: AHMEDABAD-382150 GUJARAT, INDIA INDIAPARENTERAL ORDINARY INFUSION DRY VIALS/BOTTLES1.0X500.0 ML BOTTLE01/07/2010
212NDA/MAL/HDP/1719NIRMA LIMITED (HEALTHCARE DI VISION) NIRLIFE HEALTHCARELIFE PHARMA AFRICA LIMITEDNIRMIN 10 PLUSMULTI-INGREDIENTMULTI-INGREDIENTACULIFE HEALTH CARE, FORMALLY NIRMA(HEALTHCARE DIVISION)-VILLAGE: SACHANA, TALUKA: VIRAMGAM DISTRICT: AHMEDABAD-382150 GUJARAT, INDIA INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X500.0 ML BOTTLE01/07/2010
213NDA/MAL/HDP/4868NIRMA LIMITED (HEALTHCARE DI VISION) NIRLIFE HEALTHCARELIFE PHARMA AFRICA LIMITEDFLUCANIRFLUCONAZOLE2MG/MLACULIFE HEALTHCARE PVT LTD-VILLAGE SACHANA, TALUKA, VIRAMGAM, DIST. AHMEDABAD 382150, GUJARAT INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X100.0 ML BOTTLE01/07/2011
214NDA/MAL/HDP/7189ACULIFE HEALTHCARELIFE PHARMA AFRICA LIMITEDMERONIRMEROPENEM SODIUM1000MGACULIFE HEALTHCARE PVT. LTD-VILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARAT INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0 G VIAL + 1*20ML AMPOULE OF WFI29/11/2017
215NDA/MAL/HDP/8317ACULIFE HEALTHCARELIFE PHARMA AFRICA LIMITEDMERONIR 500MEROPENEM500MGACULIFE HEALTHCARE PVT. LTD-VILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARAT INDIAPARENTERAL ORDINARY DRY VIALS1.0X500.0 MG VIAL + 1*10ML AMPOULE OF WFI29/11/2017
216NDA/MAL/HDP/8318ACULIFE HEALTHCARELIFE PHARMA AFRICA LIMITEDB-CANE HEAVYBUPIVACAINE HYDROCHLORIDE BP5 MG/MLACULIFE HEALTHCARE PVT. LTD-VILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARAT INDIAPARENTERAL ORDINARY AMPOULES1.0X4.0 ML AMPOULE29/11/2017
217NDA/MAL/HDP/0058NIRMA LIMITED.LIFE PHARMA AFRICA LIMITEDWATER FOR INJECTION B.P.WATER FOR INJECTIONN/AACULIFE HEALTHCARE PVT. LTD-VILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARAT INDIAPARENTERAL ORDINARY AMPOULES1.0X5.0 ML AMPOULE,1.0X10.0 ML AMPOULE01/07/1997
218NDA/MAL/HDP/2158NIRMA LIMITED (HEALTHCARE DI VISION) NIRLIFE HEALTHCARELIFE PHARMA AFRICA LIMITEDNIRPIDINTRAVENOUS FAT EMULSION20%W/VACULIFE HEALTHCARE PVT. LTD-VILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARAT INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X500.0 ML BOTTLE01/07/2010
219NDA/MAL/HDP/2156NIRMA LIMITED (HEALTHCARE DI VISION) NIRLIFE HEALTHCARELIFE PHARMA AFRICA LIMITEDNIRPID 10 INTRAVENOUS FAT EMULSIONSOYA OIL10%W/VACULIFE HEALTHCARE PVT. LTD-VILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARAT INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X500.0 ML BOTTLE01/07/2011
220NDA/MAL/HDP/3208NIRMA LIMITED.LIFE PHARMA AFRICA 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 VIAL01/07/2010
221NDA/MAL/HDP/4398NIRMA LIMITED (HEALTHCARE DI VISION) NIRLIFE HEALTHCARELIFE PHARMA AFRICA LIMITEDSODIUM CHLORIDESODIUM CHLORIDE0.9 % W/VACULIFE HEALTHCARE PVT. LTD-VILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARAT INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X500.0 ML BOTTLE,1.0X250.0 ML BOTTLE01/07/1997
222NDA/MAL/HDP/4955NIRMA LIMITED.LIFE PHARMA AFRICA LIMITEDCOMPOUND SODIUM LACTATE INFU.COMPOUND SODIUM LACTATEMULTI INGREDIENTACULIFE HEALTHCARE PVT. LTD-VILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARAT INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X500.0 ML BOTTLE01/07/1997
223NDA/MAL/HDP/5064NIRMA LIMITED (HEALTHCARE DI VISION) NIRLIFE HEALTHCARELIFE PHARMA AFRICA LIMITEDMANNITOL INFUSIONMANNITOL20%W/VACULIFE HEALTHCARE PVT. LTD-VILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARAT INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X100.0 ML BOTTLE01/07/2011
224NDA/MAL/HDP/5110NIRMA LIMITED.LIFE PHARMA AFRICA LIMITEDGLUCOSE INFUSION BPDEXTROSE5%W/VACULIFE HEALTHCARE PVT. LTD-VILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARAT INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X250.0 ML BOTTLE,1.0X500.0 ML BOTTLE01/07/1997
225NDA/MAL/HDP/5214NIRMA LIMITED.LIFE PHARMA AFRICA LIMITEDNIRMETMETRONIDAZOLE500MG/100MLACULIFE HEALTHCARE PVT. LTD-VILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARAT INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X100.0 ML BOTTLE01/07/2010
226NDA/MAL/HDP/5427NIRMA LIMITED.LIFE PHARMA AFRICA LIMITEDNIRCIPCIPROFLOXACIN200MG/100MGACULIFE HEALTHCARE PVT. LTD-VILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARAT INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X100.0 ML BOTTLE01/07/2010
227NDA/MAL/HDP/6079ADCOCK INGRAM LIMITEDUGANDA HEALTH MARKETING GROUP LIMITEDALLERGEXCHLORPHENIRAMINE MALEATE4MGADCOCK INGRAM LIMITED -49C & D BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK, BANGALORE
560099, KARNATAKA STATE, INDIA
INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2017
228NDA/MAL/HDP/6758ADCOCK INGRAM LIMITEDUGANDA HEALTH MARKETING GROUP LIMITEDADCO-NAPAMOLPARACETAMOL500MGADCOCK INGRAM LIMITED -49C & D BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK, BANGALORE
560099, KARNATAKA STATE, INDIA
INDIAORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER01/07/2016
229NDA/MAL/HDP/6763ADCOCK INGRAM LIMITEDUGANDA HEALTH MARKETING GROUP LIMITEDCOMPRAL HEADACHE TABLETSPARACETAMOL+ASPIRIN+CAFFEINE ANHYDROUS100MG+400MG+130MGADCOCK INGRAM LIMITED -49C & D BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK, BANGALORE
560099, KARNATAKA STATE, INDIA
INDIAORAL SOLID ORDINARY TABLETS1.0X48.0X2.0 TABLET STRIP01/07/2005
230NDA/MAL/HDP/6759ADCOCK INGRAM LIMITEDUGANDA HEALTH MARKETING GROUP LIMITEDBETAPYNPARACETAMOL+CODEINE PHOSPHATE+DOXYLAMINE+CAFFEINE450 MG+10 MG+5 MG+50 MGADCOCK INGRAM LIMITED -49C & D BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK, BANGALORE
560099, KARNATAKA STATE, INDIA
INDIAORAL SOLID ORDINARY TABLETS2.0X9.0 TABLET BLISTER,6.0X9.0 TABLET BLISTER,1.0X1.0X9.0 TABLET BLISTER01/07/1999
231NDA/MAL/HDP/0496ADCOCK INGRAM LIMITEDUGANDA HEALTH MARKETING GROUP LIMITEDMYPRODOLPARACETAMOL + IBUPROFEN + CODEINE PHOSPHATE250MG + 200MG + 10MGADCOCK INGRAM LIMITED -49C & D BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK, BANGALORE
560099, KARNATAKA STATE, INDIA
INDIAORAL SOLID ORDINARY CAPSULES1.0X20.0 CAPSULE BLISTER,1.0X3.0X10.0 CAPSULE BLISTER01/07/2014
232NDA/MAL/HDP/4356ADCOCK INGRAM LIMITEDUGANDA HEALTH MARKETING GROUP LIMITEDFRESHENBISACODYL5 MGADCOCK INGRAM LIMITED -49C & D BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK, BANGALORE
560099, KARNATAKA STATE, INDIA
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X12.0 TABLET BLISTER01/07/2016
233NDA/MAL/HDP/6761ADCOCK INGRAM LIMITEDUGANDA HEALTH MARKETING GROUP LIMITEDDAWANOL TABLETSPARACETAMOL+ACETYLSALICYLIC ACID+CAFFEINE200MG+300MG+30MGADCOCK INGRAM LIMITED -49C & D BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK, BANGALORE
560099, KARNATAKA STATE, INDIA
DAR AL DAWA-NA’UR – PRINCE HASHEM BIN AL-HUSSEIN STREET P.O. BOX 9364 AMMAN 11191 JORDAN
KENYAORAL SOLID ORDINARY TABLETS1.0X100.0 TABLET CARTON01/07/1997
234NDA/MAL/HDP/0713DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDPANTO-DENK 20PANTOPRAZOLE SODIUM SESQUIHYDRATE20MGADVANCE PHARMA GMBH..-WALLENRODER STR.12-14, 13435 BERLIN GERMANYORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X2.0X14.0 TABLET BLISTER01/07/2015
235NDA/MAL/HDP/0715DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDPANTO-DENK 40PANTOPRAZOLE SODIUM SESQUIHYDRATE40MGADVANCE PHARMA GMBH..-WALLENRODER STR.12-14, 13435 BERLIN GERMANYORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X2.0X14.0 TABLET BLISTER01/07/2015
236NDA/MAL/HDP/7631ADWIAWIDE SPECTRUM ENTERPRISES (U) LIMITEDAMADOL 100MG SR TABLETTRAMADOL HYDROCHLORIDE100MGADWIA CO. S.A.E-10TH OF RAMADAN CITY, INDUSTRIAL AREA A2, EGYPT EGYPTORAL SOLID RETARD TABLETS1.0X1.0X10.0 TABLET BLISTER25/07/2018
237NDA/MAL/HDP/4535DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDCLERON 250CLARITHROMYCIN250MGAEGIS LTD-17 ATHINON STREET, ERGATON INDUSTRIAL AREA, NICOSIA CYPRUS CYPRUSORAL SOLID ORDINARY COATED TABLETS1.0X2.0X7.0 TABLET BLISTER01/07/2008
238NDA/MAL/HDP/6060NOVARTIS ACCESSSURGIPHARM (U) LIMITEDSALBUTAMOLSALBUTAMOL100MCGAEROPHARM GMBH...-RUDOLSTADT ALLEMAGNEGERMANYLUNG ADMINISTRATION LIQUID FOR INHALATION1.0X200.0 METERED DOSE CONTAINER01/07/2017
239NDA/MAL/HDP/1569ABBVIE (PTY) LTDMEDICAL ACCESS (UGANDA) LIMITEDKALETRALOPINAVIR+RITONAVIR80MG + 20MGAESICA PHARMACEUTICALS SRL-QUEENBOROUGH KENT ME 11 5EL, UNITED KINGDOM UNITED KINGDOMORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X5.0X1.0X60.0 ML BOTTLE01/07/2007
240NDA/MAL/HDP/1805MSD (PTY) LIMITED SASURGIPHARM (U) LIMITEDJANUMETSITAGLIPTIN + METFORMIN HYDROCHLORIDE50MG + 1000MGAESICA QUEESNBOROUGH LTD .-NORTH ROAD, QUEENBOROUGH KENT ME 11 5EL, UNITED KINGDOM UNITED KINGDOMORAL SOLID ORDINARY FILM-COATED TABLETS1.0X4.0X14.0 TABLET BLISTER01/07/2014
241NDA/MAL/HDP/1873MSD (PTY) LIMITED SASURGIPHARM (U) LIMITEDJANUMETSITAGLIPTIN + METFORMIN HYDROCHLORIDE50MG + 850MGAESICA QUEESNBOROUGH LTD .-NORTH ROAD, QUEENBOROUGH KENT ME 11 5EL, UNITED KINGDOM UNITED KINGDOMORAL SOLID ORDINARY TABLETS1.0X4.0X14.0 TABLET BLISTER01/07/2014
242NDA/MAL/HDP/3506ABBVIE (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDULTANESEVOFLURANE100%W/WAESICA QUEESNBOROUGH LTD- NORTH RD. QUEENSBOROUGH KENTUNITED KINGDOMNASAL SYSTEMIC UNIT DOSE LIQUIDS1.0X250.0 ML BOTTLE01/07/2011
243NDA/MAL/HDP/8300AFRICURE PHARMACEUTICALS (INDIA) PRIVATELIMITEDROYAL PHARMA 2011 LIMITEDCIPRONE-500CIPROFLOXACIN HYDROCHLORIDE500MGAFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED (755793)-PLOT 9-12,DEWAN & SONS INDUSTRIAL. AREA, VEOOR,PALGHAR-401404. INDIA. INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2007
244NDA/MAL/HDP/8299NAME AFRICURE PHARMACEUTICALS (INDIA) PRIVATELIMITEDROYAL PHARMA 2011 LIMITEDDICLOFENAC TABLETS BPDICLOFENAC SODIUM50MGAFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED (755793)-PLOT 9-12,DEWAN & SONS INDUSTRIAL. AREA, VEOOR,PALGHAR-401404. INDIA. INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2007
245NDA/MAL/HDP/8302NAME AFRICURE PHARMACEUTICALS (INDIA) PRIVATELIMITEDROYAL PHARMA 2011 LIMITEDSIMFEN 400MGIBUPROFEN400MGAFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED (755793)-PLOT 9-12,DEWAN & SONS INDUSTRIAL. AREA, VEOOR,PALGHAR-401404. INDIA. INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER01/07/2008
246NDA/MAL/HDP/8185AFRICURE PHARMACEUTICALS (INDIA) LTDROYAL PHARMA 2011 LIMITEDINDOSIMINDOMETHACIN25MGAFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED (755793)-PLOT 9-12,DEWAN & SONS INDUSTRIAL. AREA, VEOOR,PALGHAR-401404. INDIA. INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER01/07/2008
247NDA/MAL/HDP/8307NAME AFRICURE PHARMACEUTICALS (INDIA) PRIVATELIMITEDROYAL PHARMA 2011 LIMITEDMETFORMIN 500METFORMIN500MGAFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED (755793)-PLOT 9-12,DEWAN & SONS INDUSTRIAL. AREA, VEOOR,PALGHAR-401404. INDIA. INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2008
248NDA/MAL/HDP/8184AFRICURE PHARMACEUTICALS (INDIA) LTDROYAL PHARMA 2011 LIMITEDTETRASIMTETRACYCLINE HYDROCHLORIDE250MGAFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED (755793)-PLOT 9-12,DEWAN & SONS INDUSTRIAL. AREA, VEOOR,PALGHAR-401404. INDIA. INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER,1.0X500.0 CAPSULE CONTAINER01/07/2008
249NDA/MAL/HDP/8228AFRICURE PHARMACEUTICALS (INDIA) LTDROYAL PHARMA 2011 LIMITEDVITAMIN B-COMPLEX (BEEKO)VITAMINS B1 + B2 + B6 + NIACINAMIDE1MG +1MG +1MG +15MGAFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED (755793)-PLOT 9-12,DEWAN & SONS INDUSTRIAL. AREA, VEOOR,PALGHAR-401404. INDIA. INDIAORAL SOLID ORDINARY OTHER COATED TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2017
250NDA/MAL/HDP/1855INTERMEDROYAL PHARMA 2011 LIMITEDQUININE SULPHATEQUININE SULPHATE300MGAFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED (755793)-PLOT 9-12,DEWAN & SONS INDUSTRIAL. AREA, VEOOR,PALGHAR-401404. INDIA. INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER01/07/2004
251NDA/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 BLISTER01/07/2005
252NDA/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 BLISTER01/07/2005
253NDA/MAL/HDP/5161AFRICURE PHARMACEUTICALS (INDIA) PRIVATELIMITEDROYAL PHARMA 2011 LIMITEDGRISEOSIM-500GRISEOFULVIN500MGAFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED (755793)-PLOT 9-12,DEWAN & SONS INDUSTRIAL. AREA, VEOOR,PALGHAR-401404. INDIA. INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2005
254NDA/MAL/HDP/2243AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITEDROYAL PHARMA 2011 LIMITEDSIMDOL TABLETSPARACETAMOL500MGAFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED-PLOT 9-12,DEWAN & SONS INDL. AREA, VEOOR,PALGHAR-401404. INDIA.
INDIAORAL SOLID ORDINARY TABLETS10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER01/07/1997
255NDA/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 CONTAINER01/07/1997
256NDA/MAL/HDP/3760AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITEDROYAL PHARMA 2011 LIMITEDCOMPOUND MAGNESIUM TRISILICATEMAGNESIUM TRISILICATE370MGAFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED-PLOT 9-12,DEWAN & SONS INDL. AREA, VEOOR,PALGHAR-401404. INDIA.
INDIAORAL SOLID ORDINARY CHEWABLE TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER01/07/1997
257NDA/MAL/HDP/4112AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITEDROYAL PHARMA 2011 LIMITEDERYTHRONE TABLETS 250MGERYTHROMYCIN250MGAFRICURE 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 CONTAINER
258NDA/MAL/HDP/4701AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITEDROYAL PHARMA 2011 LIMITEDMEBRONE 100 TABLETSMEBENDAZOLE100MGAFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED-PLOT 9-12,DEWAN & SONS INDL. AREA, VEOOR,PALGHAR-401404. INDIA.
INDIAORAL SOLID ORDINARY CHEWABLE TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X6.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER01/07/1997
259NDA/MAL/HDP/4928AFRICURE PHARMACEUTICALS (INDIA) LTDROYAL PHARMA 2011 LIMITEDFOLIC ACID TABLETSFOLIC ACID5MGAFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED-PLOT 9-12,DEWAN & SONS INDL. AREA, VEOOR,PALGHAR-401404. INDIA.
INDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET STRIP01/07/1997
260NDA/MAL/HDP/4971AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITEDROYAL PHARMA 2011 LIMITEDFRUSEMIDE TABLETSFUROSEMIDE40MGAFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED-PLOT 9-12,DEWAN & SONS INDL. AREA, VEOOR,PALGHAR-401404. INDIA.
INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET STRIP,1.0X1000.0 TABLET CONTAINER01/07/1997
261NDA/MAL/HDP/6670AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITEDROYAL PHARMA 2011 LIMITEDMETROSIM-200METRONIDAZOLE200MGAFRICURE 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 CONTAINER01/07/1997
262NDA/MAL/HDP/0440AGIO PHARMACEUTICALS LTDROYAL PHARMA 2011 LIMITEDAGICLOB-GMCLOBETASOL/GENTAMICIN/MICONAZOLE0.5MG+3.4MG+20MG/1GAGIO PHARMACEUTICALS LTD-PLOT NO. T-81, 82 MIDC, BHOSARI, PUNE-26 INDIATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE01/07/2014
263NDA/MAL/HDP/0445AGIO PHARMACEUTICALS LTDROYAL PHARMA 2011 LIMITEDAZIAGIO 500AZITHROMYCIN500MGAGIO PHARMACEUTICALS LTD-PLOT NO. T-81, 82 MIDC, BHOSARI, PUNE-26 INDIAORAL SOLID ORDINARY TABLETS1.0X3.0 TABLET BLISTER01/07/2014
264NDA/MAL/HDP/0441AGIO PHARMACEUTICALS LTDROYAL PHARMA 2011 LIMITEDAGISECSECNIDAZOLE1GMAGIO PHARMACEUTICALS LTD-PLOT NO. T-81, 82 MIDC, BHOSARI, PUNE-26 INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0 TABLET BLISTER01/07/2015
265NDA/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 BLISTER01/07/1998
266NDA/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 BOTTLE01/07/2007
267NDA/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 BOTTLE01/07/2007
268NDA/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 BLISTER01/07/2007
269NDA/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 BLISTER01/07/2007
270NDA/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 BOTTLE01/07/2007
271NDA/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 BLISTER01/07/2007
272NDA/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 CONTAINER01/07/2007
273NDA/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 BLISTER07/07/2007
274NDA/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 BLISTER01/07/2012
275NDA/MAL/HDP/3031GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOMETHASONEDEXAMETHASONE0.5MGAGOG PHARMA LTD.-NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER01/07/2007
276NDA/MAL/HDP/3063GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGODIC-50DICLOFENAC SODIUM50MGAGOG PHARMA LTD.-NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER01/07/2007
277NDA/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 CONTAINER01/07/2007
278NDA/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 BLISTER01/07/2012
279NDA/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 TUBE01/07/2013
280NDA/MAL/HDP/1786GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGONAC TABLETS (THANE)DICLOFENAC50MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER01/07/2001
281NDA/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 BLISTER01/07/2005
282NDA/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 STRIP01/07/2005
283NDA/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 BLISTER01/07/2006
284NDA/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 BOTTLE01/07/2006
285NDA/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 BLISTER01/07/2006
286NDA/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 BLISTER01/07/2006
287NDA/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 BLISTER01/07/2011
288NDA/MAL/HDP/1123GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOPARPARACETAMOL500 MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CONTAINER01/07/2012
289NDA/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 TUBE01/07/2012
290NDA/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 BOTTLE01/07/2013
291NDA/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 TUBE01/07/2013
292NDA/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 CARTON01/07/2013
293NDA/MAL/HDP/1242GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDTOPHEN-100PHENYTOIN100MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER01/07/2013
294NDA/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 TUBE01/07/2013
295NDA/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 TUBE01/07/2013
296NDA/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 BLISTER01/07/2014
297NDA/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 BLISTER01/07/2014
298NDA/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 TUBE01/07/2016
299NDA/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 TUBE01/07/2016
300NDA/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 CONTAINER01/07/2007
301NDA/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 BOTTLE01/07/2000
302NDA/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 CONTAINER01/07/2011
303NDA/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 BLISTER01/07/2010
304NDA/MAL/HDP/3634GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOPLUSPARACETAMOL+DEXTROMETHORPHAN HCL+ CHLORPHENIRAMINE+PHENYLEPHRINE HCL500MG+15MG+2MG+10MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIAORAL SOLID ORDINARY CAPSULES1.0X2.0X10.0 CAPSULE BLISTER01/07/2008
305NDA/MAL/HDP/3391GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDCEZIN TABLETCETIRIZINE10MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X2.0X5.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,100.0X10.0 TABLET BLISTER01/07/2017
306NDA/MAL/HDP/6041GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDCANDIZOLCLOTRIMAZOLE100MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAVAGINAL TABLETS1.0X6.0 PESSARY STRIP01/07/2017
307NDA/MAL/HDP/8157GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDD LYTE- PLAINANHYDROUS GLUCOSE + SODIUM CHLORIDE + TRISODIUM CITRATE + POTASSIUM CHLORIDE13.50G + 2.60G + 2.90G +1.50G/ 1LAGOG 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 POWDERS1.0X20.5 G SACHET01/07/2016
308NDA/MAL/HDP/8154GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOGCORTHYDROCORTISONE ACETATE1%W/WAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE01/07/2013
309NDA/MAL/HDP/8178GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDNYSTAGO TABLETSNYSTATIN500,000I.UAGOG 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 TABLETS1.0X1.0X10.0 TABLET BLISTER,1.0X100.0 TABLET BOTTLE,1.0X10.0X10.0 TABLET BLISTER01/07/2005
310NDA/MAL/HDP/8151GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGO-CVITAMIN C100MGAGOG 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 TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET STRIP01/07/2005
311NDA/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 BOTTLE01/07/1998
312NDA/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 CARTON01/07/1998
313NDA/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 BLISTER01/07/1998
314NDA/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 CONTAINER01/07/1998
315NDA/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 BOTTLE01/07/2000
316NDA/MAL/HDP/2007GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDB-COX TABLETSVITAMIN B COMPLEXBCP FORMULAAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER01/07/2001
317NDA/MAL/HDP/2335GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOBEN TABLETS(THANE)MEBENDAZOLE100MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY CHEWABLE TABLETS10.0X10.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,1.0X250.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER01/07/2001
318NDA/MAL/HDP/1544GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDPROMETHAZINE HYDROCHLORIDE B.PPROMETHAZINE HCL25MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER01/07/2004
319NDA/MAL/HDP/1809GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOVIT-6PYRIDOXINE25MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER01/07/2004
320NDA/MAL/HDP/2031GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOZID TABLETSISONIAZID100MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER01/07/2004
321NDA/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 CONTAINER01/07/2007
322NDA/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 BOTTLE01/07/2007
323NDA/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 CONTAINER01/07/2007
324NDA/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 BLISTER01/07/2007
325NDA/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 BLISTER01/07/2007
326NDA/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 BLISTER01/07/2007
327NDA/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 STRIP01/07/2007
328NDA/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 BLISTER01/07/2007
329NDA/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 BLISTER01/07/2008
330NDA/MAL/HDP/0022GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDQUININE SULPHATEQUININE SULPHATE300MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER01/07/2009
331NDA/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 INDIAORAL SOLID ORDINARY OTHER COATED TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER01/07/2009
332NDA/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 BLISTER01/07/2009
333NDA/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 BLISTER01/07/2009
334NDA/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 CONTAINER01/07/2010
335NDA/MAL/HDP/2095GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOMOLPARACETAMOL100MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER01/07/2010
336NDA/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 BOTTLE01/07/2010
337NDA/MAL/HDP/2571GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDCO-METHERARTEMETHER + LUMEFANTRINE180 MG + 1080 MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X60.0 ML BOTTLE,1.0X30.0 ML BOTTLE01/07/2010
338NDA/MAL/HDP/1054GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAZ-250AZITHROMYCIN250MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY CAPSULES1.0X1.0X6.0 CAPSULE BLISTER01/07/2011
339NDA/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 BLISTER01/07/2011
340NDA/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 CONTAINER01/07/2011
341NDA/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 BLISTER01/07/2011
342NDA/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 BOTTLE01/07/2011
343NDA/MAL/HDP/1748GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAZ-500AZITHROMYCIN500MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY CAPSULES1.0X3.0 CAPSULE BLISTER01/07/2011
344NDA/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 BLISTER01/07/2011
345NDA/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 BOTTLE01/07/2013
346NDA/MAL/HDP/1124GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGO SCRUBCHLORHEXIDINE GLUCONATE4%W/VAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIATOPICAL EXTERNAL LIQUIDS1.0X1.0X500.0 ML BOTTLE01/07/2013
347NDA/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 BLISTER01/07/2013
348NDA/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 BLISTER01/07/2013
349NDA/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 BLISTER01/07/2013
350NDA/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 BLISTER01/07/2013
351NDA/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 BLISTER01/07/2013
352NDA/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 CONTAINER01/07/2013
353NDA/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 BLISTER01/07/2013
354NDA/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 BOTTLE01/07/2013
355NDA/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 TUBE01/07/2013
356NDA/MAL/HDP/1142GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDCANDIZOLCLOTRIMAZOLE1%W/WAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIATOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE01/07/2013
357NDA/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 BOTTLE01/07/2013
358NDA/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 BLISTER01/07/2014
359NDA/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 TUBE01/07/2014
360NDA/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 BLISTERS01/07/2015
361NDA/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 TUBE01/07/2013
362NDA/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 BOTTLE01/07/1998
363NDA/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 BLISTER01/07/2000
364NDA/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 BLISTER01/07/2011
365NDA/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 CONTAINER01/07/2003
366NDA/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 BLISTER01/07/2011
367NDA/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 BOTTLE01/07/2010
368NDA/MAL/HDP/3451GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOPHENOL CAPSULES (THANE0CHLORAMPHENICOL250MGAGOG 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,1.0X100.0 CAPSULE CONTAINER,1.0X1000.0 CAPSULE CONTAINER,1.0X500.0 CAPSULE CONTAINER01/07/1998
369NDA/MAL/HDP/3647GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDNYSTAGO ORAL SUSPENSIONNYSTATIN100000 IUAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL TOPICAL SUSPENSIONS1.0X30.0 ML BOTTLE01/07/2008
370NDA/MAL/HDP/3746GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDBENDROBENDROFLUMETHIAZIDE5MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER01/07/2011
371NDA/MAL/HDP/3748GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOSPIRINACETYL SALICYLIC ACID100MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER01/07/2010
372NDA/MAL/HDP/3773GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOBUTOL-4SALBUTAMOL SULPHATE4 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,1.0X100.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER01/07/2005
373NDA/MAL/HDP/3794GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOMET-200METRONIDAZOLE200MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER01/07/2005
374NDA/MAL/HDP/3860GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOLACLACTULOSE3.35MG/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,1.0X60.0 ML BOTTLE,1.0X200.0 ML BOTTLE01/07/2009
375NDA/MAL/HDP/3991GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOFULVINGRISEOFULVIN TABLETS500MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2008
376NDA/MAL/HDP/3996GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOTOIN TABLETSNITROFURANTOIN BP100MGAGOG 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,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER01/07/2007
377NDA/MAL/HDP/3998GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOKOFF SYRUPTERBUTALINE SULPHATE +GUAIFENESIN+BROMHEXINE HYDROCHLORIDE +LEVOMENTHOL1.25MG/5ML+50MG//5ML+4MG/5ML+2.5MG/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 SYRUPS1.0X1.0X100.0 ML BOTTLE,1.0X1.0X60.0 ML BOTTLE01/07/2008
378NDA/MAL/HDP/4001GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOCOLD PLUS SYRUPPARACETAMOL+PHENYLEPHRINE+CHLORPHENIRAMINE+SODIUM CITRATE125MG/5ML+2.5MG/5ML+1MG/5ML+60MG /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 SYRUPS1.0X1.0X100.0 ML BOTTLE,1.0X1.0X60.0 ML BOTTLE01/07/2008
379NDA/MAL/HDP/4002GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOCIDALUMINIUM HYDROXIDE+MAGNESIUM HYDROXIDE250MG/5ML+ 250MG/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,1.0X170.0 ML BOTTLE01/07/2007
380NDA/MAL/HDP/4064GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDTERAFINETERBINAFINE250MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X1.0X14.0 TABLET BLISTER01/07/2010
381NDA/MAL/HDP/4188GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOPRAZPRAZIQUANTEL600MGAGOG 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,1.0X2.0X4.0 TABLET BLISTER,1.0X1.0X4.0 TABLET BLISTER01/07/2013
382NDA/MAL/HDP/4329GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGO-CPMCHLORPHENIRAMINE MALEATE2MG/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 SYRUPS1.0X1.0X100.0 ML BOTTLE,1.0X1.0X60.0 ML BOTTLE01/07/2010
383NDA/MAL/HDP/4406GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDSATISFIL -100SILDENAFIL100MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X4.0 TABLET BLISTER01/07/2011
384NDA/MAL/HDP/4526GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAZ-500AZITHROMYCIN500MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0 TABLET BLISTER01/07/2011
385NDA/MAL/HDP/4598GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAZ-250AZITHROMYCIN250MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X6.0 TABLET BLISTER01/07/2011
386NDA/MAL/HDP/4605GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGODRYL SYRUPBROMHEXINE HCL+DEXTROMETHORPHAN HBR+AMMONIUM CHLORIDE+MENTHOL4MG/5ML+5MG/5ML+50MG/5ML+2.5MG/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 SYRUPS1.0X1.0X100.0 ML BOTTLE,1.0X1.0X60.0 ML BOTTLE01/07/2009
387NDA/MAL/HDP/4751GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDFEROLFERROUS SULPHATE200MGAGOG 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 BLISTER,1.0X100.0X10.0 TABLET BLISTER01/07/2009
388NDA/MAL/HDP/4766GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOBEN SUSPENSIONMEBENDAZOLE100MG/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 SUSPENSIONS1.0X30.0 ML BOTTLE01/07/2001
389NDA/MAL/HDP/4769GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOBEXMEBENDAZOLE100MGAGOG 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 TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER01/07/2009
390NDA/MAL/HDP/4805GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOFENIBUPROFEN200MGAGOG 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 TABLETS10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER01/07/2000
391NDA/MAL/HDP/4806GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOFERFERROUS SULPHATE+FOLIC ACID200MG + 0.25MGAGOG 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,1.0X100.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER01/07/2009
392NDA/MAL/HDP/4807GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOFORMINMETFORMIN500MGAGOG 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,1.0X1000.0 TABLET CONTAINER01/07/2011
393NDA/MAL/HDP/4809GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOCORT SKIN CREAMHYDROCORTISONE0.1%W/WAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE01/07/2013
394NDA/MAL/HDP/4811GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOGYLMETRONIDAZOLE200MGAGOG 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 BLISTER01/07/2009
395NDA/MAL/HDP/4812GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOMETROL SUSPENSIONMETRONIDAZOLE BENZOATE125MG/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 BOTTLE01/07/2001
396NDA/MAL/HDP/4813GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOMETROL TABLETS (THANE)METRONIDAZOLE200MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X500.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER01/07/1998
397NDA/MAL/HDP/4836GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDMETRONMETRONIDAZOLE200MGAGOG 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 BLISTER,1.0X1000.0 TABLET CONTAINER01/07/2009
398NDA/MAL/HDP/4903GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDCMT-TABLETSMAGNESIUM TRISILICATE+DRIED ALUMINIUM HYDROXIDE+PEPPERMINT OIL250MG+120MG+0.003MLAGOG 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 TABLETS1.0X100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER01/07/2008
399NDA/MAL/HDP/4924GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDMULTIVIT TABLETMULTIVITAMINMULTI-INGREDIENTAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY CHEWABLE TABLETS1.0X1000.0 TABLET CONTAINER01/07/2001
400NDA/MAL/HDP/4940GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDFOLONFOLIC ACID5MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER01/07/2006
401NDA/MAL/HDP/5115GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDINDOS-25INDOMETHACIN25MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY CAPSULES1000.0 CAPSULE CONTAINER,20.0X5.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER01/07/2000
402NDA/MAL/HDP/5188GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDITRAZ CAPSULESITRACONAZOLE100MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY CAPSULES1.0X3.0X5.0 CAPSULE BLISTER,1.0X6.0X10.0 CAPSULE BLISTER01/07/2009
403NDA/MAL/HDP/5272GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDDIXDIGOXIN0.25MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER01/07/2011
404NDA/MAL/HDP/5302GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDIBUGO-COMBIIBUPROFEN + PARACETAMOL + CAFFEINE200MG + 325MG + 30MGAGOG 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 BLISTER,1.0X100.0X10.0 CAPSULE BLISTER01/07/2014
405NDA/MAL/HDP/5305GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDIBUGO - 200IBUPROFEN200MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY OTHER COATED TABLETS1.0X100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER01/07/2008
406NDA/MAL/HDP/5419GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGO-CPMCHLORPHENIRAMINE4MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER01/07/2005
407NDA/MAL/HDP/5429GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDCIPRO-500CIPROFLOXACIN500MGAGOG 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 TABLETS1.0X100.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0 TABLET CARTON01/07/2006
408NDA/MAL/HDP/5435GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDPICPARACETAMOL+IBUPROFEN+CAFFEINE500MG+200MG+30MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X25.0X4.0 TABLET STRIP01/07/2015
409NDA/MAL/HDP/5464GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDCO-METHERARTEMETHER + LUMEFANTRINE20MG + 120MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X4.0 TABLET BLISTER,1.0X3.0X8.0 TABLET BLISTER,1.0X6.0 TABLET BLISTER,2.0X6.0 TABLET BLISTER,4.0X6.0 TABLET BLISTER,1.0X1.0X24.0 TABLET BLISTER,1.0X1.0X6.0 TABLET BLISTER,1.0X1.0X12.0 TABLET BLISTER01/07/2007
410NDA/MAL/HDP/5482GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGO-LINSALBUTAMOL2MG/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 SYRUPS1.0X1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE01/07/2010
411NDA/MAL/HDP/5495AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOCAL TABLETSCALCIUM LACTATE300MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER01/07/2001
412NDA/MAL/HDP/6142GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOCARBACTIVATED CHARCOAL0.25MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X100.0 TABLET BOTTLE,1.0X10.0X10.0 TABLET BLISTER01/07/2016
413NDA/MAL/HDP/6190GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDD-LYTEANHYDROUS GLUCOSE+SODIUM CHLORIDE+TRISODIUM CITRATE+POTASSIUM CHLORIDE,ANHYDROUS GLUCOSE+SODIUM CHLORIDE+TRISODIUM CITRATE+POTASSIUM CHLORIDE,ANHYDROUS GLUCOSE+SODIUM CHLORIDE+TRISODIUM CITRATE+POTASSIUM CHLORIDE2.7MG+0.52MG+0.58MG+0.30MG PER 200ML SACHET,6.75MG+1.30MG+1.45MG+0.75MG PER 500ML SACHET,13.5MG+2.60MG+2.90MG+1.50MG 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 SOLUBLE POWDERS1.0X500.0 ML SACHET,1.0X1000.0 ML SACHET,1.0X200.0 ML SACHET01/07/2015
414NDA/MAL/HDP/6631GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOBURNSILVER SULFADIAZINE1%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 TUBE,1.0X500.0 G JAR01/07/2016
415NDA/MAL/HDP/3790GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOFLOX-PPEFLOXACIN400MGAGOG PHARMA-PLOT 33 SECTOR THE VASAI-TULUKA CO-OP ESTATE LTD INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2005
416NDA/MAL/HDP/3985GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOMYCIN SUSPENSIONERYTHROMYCIN ESTOLATE125MG/5MLAGOG PHARMA-PLOT 33 SECTOR THE VASAI-TULUKA CO-OP ESTATE LTD INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X1.0X100.0 ML BOTTLE01/07/2008
417NDA/MAL/HDP/7241EXPHAR SA.SURGIPHARM (U) LIMITEDGENTASOLGENTAMICIN SULFATE0.3%W/VAHLCON PARENTERAL (I) LTD.--SP-918,BHLWADI (RAJ) INDIA M.LIC.: RAJ 2002 INDIAOPHTHALMIC DROPS1.0X5.0 ML BOTTLE29/11/2017
418NDA/MAL/HDP/1078MICRO LABS LTDLABOREX UGANDA LIMITEDLEVOBACT INFUSIONLEVOFLOXACIN HEMIHYDRATE500MGAHLCON PARENTERALS (INDIA) LTD-SP-917-918, PHASE-III BHIWADI-301019, ALWAR, RAJASTHAN INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X100.0 ML BOTTLE01/07/2013
419NDA/MAL/HDP/5073CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDDEXONA EYE/EAR DROPDEXAMATHASONE SODIUM PHOSPHATE+NEOMYCIN SULPHATE0.35%W/V+0.1%W/VAHLCON PARENTERALS (INDIA) LTD-SP-917-918, PHASE-III BHIWADI-301019, ALWAR, RAJASTHAN INDIAOPHTHALMIC DROPS1.0X5.0 ML BOTTLE,1.0X2.5 ML BOTTLE01/07/1997
420NDA/MAL/HDP/6082EXPHAR SASURGIPHARM (U) LIMITEDCROMSOLSODIUM CROMOGLYCATE2%W/VAHLCONPARENTERALS (INDIA) LIMITED-SP-918, PHASE-III, BHIWADI-301019, RAJASTHAN (INDIA)
TEL: +91-1493-305300 (30 LINES)
FAX: +91-1493-221045, 305345
INDIAOPHTHALMIC DROPS1.0X5.0 ML BOTTLE01/07/2017
421NDA/MAL/HDP/6354EXPHAR SA.SURGIPHARM (U) LIMITEDTIMOSOL ®TIMOLOL MALEATEO.5%W/VAHLCONPARENTERALS (INDIA) LIMITED-SP-918, PHASE-III, BHIWADI-301019, RAJASTHAN (INDIA)
TEL: +91-1493-305300 (30 LINES)
FAX: +91-1493-221045, 305345
INDIAOPHTHALMIC DROPS1.0X5.0 ML BOTTLE01/07/2017
422NDA/MAL/HDP/6537EXPHAR SASURGIPHARM (U) LIMITEDCARBOSOLCARMELLOSE SODIUM0.5%W/VAHLCONPARENTERALS (INDIA) LIMITED-SP-918, PHASE-III, BHIWADI-301019, RAJASTHAN (INDIA)
TEL: +91-1493-305300 (30 LINES)
FAX: +91-1493-221045, 305345
INDIAOPHTHALMIC DROPS1.0X10.0 ML BOTTLE31/01/2018
423NDA/MAL/HDP/8129MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIAKIMSY MEDS LTDATOREG 20ATORVASTATIN CALCIUM20MGAIZANT DRUG RESEARCH SOLUTIONS PVT LTD.-SY. N0. 172 & 173,PARK ROAD, DULAPALLY VILLAGE INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2017
424NDA/MAL/HDP/6518MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIAKIMSY MEDS LTDCARDISAR HTVALSARTAN + HYDROCHLOROTHIAZIDE80 MG + 25 MGAIZANT DRUG RESEARCH SOLUTIONS PVT LTD-SY. NO 172 &. 173, APPAREL PARK ROAD, DULAPALLY VILLAGE, QUTHBULLAPUR MANDAL, RR DIST., HYDERABAD- 500 100, TELANGANA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER28/08/2019
425NDA/MAL/HDP/7320MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIAKIMSY MEDS LTDCARDISAR HTVALSARTAN + HYDROCHLOROTHIAZIDE160 MG + 25 MGAIZANT DRUG RESEARCH SOLUTIONS PVT LTD-SY. NO 172 &. 173, APPAREL PARK ROAD, DULAPALLY VILLAGE, QUTHBULLAPUR MANDAL, RR DIST., HYDERABAD- 500 100, TELANGANA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER28/08/2019
426NDA/MAL/HDP/7322MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIAKIMSY MEDS LTDCARDISAR HTVALSARTAN + HYDROCHLOROTHIAZIDE160MG + 12.5MGAIZANT DRUG RESEARCH SOLUTIONS PVT LTD-SY. NO 172 &. 173, APPAREL PARK ROAD, DULAPALLY VILLAGE, QUTHBULLAPUR MANDAL, RR DIST., HYDERABAD- 500 100, TELANGANA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER28/08/2019
427NDA/MAL/HDP/7735AJANTA PHARMA LIMITEDABACUS PHARMA (AFRICA) LIMITEDIBUMOL 400PARACETAMOL + IBUPROFEN325MG + 400MGAJANTA PHARMA LIMITED PAITHAN-MANUFACTURING UNIT B-4/5/6 MIDC PAITHAN DISTRICT AURANGABAD 431 148 MAHARASTRA STATE INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2017
428NDA/MAL/HDP/1478AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDKAMAGRASILDENAFIL50MGAJANTA PHARMA LIMITED PAITHAN-MANUFACTURING UNIT B-4/5/6 MIDC PAITHAN DISTRICT AURANGABAD 431 148 MAHARASTRA STATE INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X1.0X4.0 TABLET BLISTER01/07/2001
429NDA/MAL/HDP/2005AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDKAMAGRA-100SILDENAFIL CITRATE100MGAJANTA PHARMA LIMITED PAITHAN-MANUFACTURING UNIT B-4/5/6 MIDC PAITHAN DISTRICT AURANGABAD 431 148 MAHARASTRA STATE INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X1.0X4.0 TABLET BLISTER01/07/2005
430NDA/MAL/HDP/1615AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDAPCALIS SXTADALAFIL20MGAJANTA PHARMA LIMITED PAITHAN-MANUFACTURING UNIT B-4/5/6 MIDC PAITHAN DISTRICT AURANGABAD 431 148 MAHARASTRA STATE INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X2.0 TABLET BLISTER01/07/2005
431NDA/MAL/HDP/1796AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDZAHA 250AZITHROMYCIN250 MGAJANTA PHARMA LIMITED PAITHAN-MANUFACTURING UNIT B-4/5/6 MIDC PAITHAN DISTRICT AURANGABAD 431 148 MAHARASTRA STATE INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER,1.0X10.0X1.0X6.0 TABLET BLISTER01/07/2006
432NDA/MAL/HDP/2040AJANTA PHARMA LIMITEDABACUS PHARMA (AFRICA) LIMITEDARTEFAN 20/120ARTEMETHER + LUMEFANTRINE20 MG + 120 MGAJANTA PHARMA LIMITED PAITHAN-MANUFACTURING UNIT B-4/5/6 MIDC PAITHAN DISTRICT AURANGABAD 431 148 MAHARASTRA STATE INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X30.0X12.0 TABLET BLISTER,1.0X3.0X8.0 TABLET BLISTER,1.0X30.0X24.0 TABLET BLISTER,1.0X30.0X18.0 TABLET BLISTER,1.0X30.0X6.0 TABLET BLISTER,1.0X1.0X6.0 TABLET BLISTER,1.0X1.0X12.0 TABLET BLISTER,1.0X1.0X24.0 TABLET BLISTER,1.0X1.0X18.0 TABLET BLISTER,1.0X1.0X24.0 TABLET BLISTER01/07/2006
433NDA/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 BLISTER01/07/2013
434NDA/MAL/HDP/3551AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDZAHA-500MGAZITHROMYCIN500MGAJANTA PHARMA LIMITED PAITHAN-MANUFACTURING UNIT B-4/5/6 MIDC PAITHAN DISTRICT AURANGABAD 431 148 MAHARASTRA STATE INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X3.0 TABLET BLISTER,1.0X10.0X1.0X3.0 TABLET BLISTER01/07/2009
435NDA/MAL/HDP/3653AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDARTEFANARTEMETHER + LUMEFANTRINE80 MG + 480 MGAJANTA PHARMA LIMITED PAITHAN-MANUFACTURING UNIT B-4/5/6 MIDC PAITHAN DISTRICT AURANGABAD 431 148 MAHARASTRA STATE INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X6.0 TABLET BLISTER (WITH AMFM LOGO),1.0X6.0 TABLET BLISTER (WITHOUT AMFM LOGO),30.0X1.0X6.0 TABLET BLISTER (WITH AMFM LOGO),30.0X1.0X6.0 TABLET BLISTER (WITHOUT AMFM LOGO)01/07/2008
436NDA/MAL/HDP/3827AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDATORFIT-10ATORVASTATIN10MGAJANTA PHARMA LIMITED PAITHAN-MANUFACTURING UNIT B-4/5/6 MIDC PAITHAN DISTRICT AURANGABAD 431 148 MAHARASTRA STATE INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X6.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER01/07/2005
437NDA/MAL/HDP/4801AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDDAZEL KITFLUCONAZOLE + AZITHROMYCIN + SECNIDAZOLE150MG + 1G + 1GAJANTA PHARMA LIMITED PAITHAN-MANUFACTURING UNIT B-4/5/6 MIDC PAITHAN DISTRICT AURANGABAD 431 148 MAHARASTRA STATE INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X4.0 TABLET BLISTER01/07/2009
438NDA/MAL/HDP/6612AJANTA PHARMA LIMITEDABACUS PHARMA (AFRICA) LIMITEDAPRAZOLE PLUS-20OMEPRAZOLE + SODIUM BICARBONATE20MG/6G + 1680MG/6GAJANTA PHARMA LIMITED PAITHAN-MANUFACTURING UNIT B-4/5/6 MIDC PAITHAN DISTRICT AURANGABAD 431 148 MAHARASTRA STATE INDIAINDIAORAL SOLID ORDINARY POWDERS1.0X20.0X6.0 G SACHET01/07/2008
439NDA/MAL/HDP/7355AJANTA PHARMA LIMITEDABACUS PHARMA (AFRICA) LIMITEDARTEFAN SUSPENSIONARTEMETHER+LUMEFANTRINE180MG+1080MGAJANTA PHARMA LIMITED.-B-41516, MIDC INDUSTRIAL AREA,
PAITHAN, AURANGABAD-431 148 DIST: AURANGABAD MAHARASHTRA,INDIA
INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X60.0 ML BOTTLE31/01/2018
440NDA/MAL/HDP/1901AJANTA PHARMA LTD 31-0ABACUS PHARMA (AFRICA) LIMITEDIBUMOLIBUPROFEN + PARACETAMOL100MG + 162.5 MG /5MLAJANTA PHARMA LIMITED-31-0 MIDC INDUSTRIAL AREA CHIKALTHANA 431210 DIST AURANGABAD MAHARASHTRA STATEINDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE01/07/2013
441NDA/MAL/HDP/0941AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDZAHAAZITHROMYCIN200MG/5MLAJANTA PHARMA LIMITED-31-0 MIDC INDUSTRIAL AREA CHIKALTHANA 431210 DIST AURANGABAD MAHARASHTRA STATEINDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X15.0 ML BOTTLE01/07/2013
442NDA/MAL/HDP/3899AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDFEDATE SYRUPSODIUM FEREDETATE + PYRIDOXINE + CYANOCOBALAMIN + FOLIC ACID216.87MG + 1.5MG + 7.5MCG + 1.5MGAJANTA PHARMA LIMITED-31-0 MIDC INDUSTRIAL AREA CHIKALTHANA 431210 DIST AURANGABAD MAHARASHTRA STATEINDIAORAL LIQUID ORDINARY SYRUPS1.0X200.0 ML BOTTLE01/07/2013
443NDA/MAL/HDP/4713AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDMEFLAMMEFENAMIC ACID50MG/5MLAJANTA PHARMA LIMITED-31-0 MIDC INDUSTRIAL AREA CHIKALTHANA 431210 DIST AURANGABAD MAHARASHTRA STATEINDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X1.0X100.0 ML BOTTLE01/07/2011
444NDA/MAL/HDP/6617AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDAPFLUCHLOROPHENERAMINE + PARACETAMOL + VITAMIN C0.5MG + 120MG + 50MGAJANTA PHARMA LIMITED-31-0 MIDC INDUSTRIAL AREA CHIKALTHANA 431210 DIST AURANGABAD MAHARASHTRA STATEINDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE01/07/2009
445NDA/MAL/HDP/8353AJANTA PHARMA LIMITEDABACUS PHARMA (AFRICA) LIMITEDNURIFER CAPSULESCARBONYL IRON + FOLIC ACID + VITAMIN B12 + VITAMIN C + ZINC SULFATE MONOHYDRATE100MG+1.5 MG + 15 MCG + 75 MG + 61.8 MGAJANTA PHARMA LIMITED-AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. INDIAORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER29/11/2017
446NDA/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. INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET STRIP01/07/2013
447NDA/MAL/HDP/3527AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDLEVOTOP-500LEVOFLOXACIN500MGAJANTA PHARMA LIMITED-AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X10.0 TABLET BLISTER01/07/2009
448NDA/MAL/HDP/3874AJANTA PHARMA LTD 31-0ABACUS PHARMA (AFRICA) LIMITEDRIDMAL 40/320DIHYDROARTEMISININ + PIPERAQUINE40MG + 320MGAJANTA PHARMA LIMITED-AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X12.0 TABLET BLISTER,1.0X1.0X3.0 TABLET BLISTER,1.0X1.0X8.0 TABLET BLISTER,1.0X1.0X9.0 TABLET BLISTER,1.0X1.0X6.0 TABLET BLISTER01/07/2010
449NDA/MAL/HDP/5379AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDZOLANAS-30LANSOPRAZOLE30MGAJANTA PHARMA LIMITED-AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. INDIAORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER01/07/2008
450NDA/MAL/HDP/8795AJANTA PHARMA LIMITEDABACUS PHARMA (AFRICA) LIMITEDARTEFAN 60/360ARTEMETHER + LUMEFANTRINE60MG + 360MGAJANTA PHARMA LIMITED-B-4/5/6 MIDC PAITHAN DISTRICT AURANGABAD MAHARASHTRA STATE INDIA 431 128INDIAORAL SOLID ORDINARY TABLETS1.0X30.0X1.0X6.0 TABLET BLISTER26/11/2019
451NDA/MAL/HDP/4365AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDACTINAC PLUSACECLOFENAC + PARACETAMOL100 MG + 500 MGAJANTA PHARMA LIMITED-B-4/5/6,MIDC AREA, PAITHAN,431 148 INDIA. INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X10.0 TABLET BLISTER01/07/2009
452NDA/MAL/HDP/7339AJANTA PHARMA LIMITEDABACUS PHARMA (AFRICA) LIMITEDADERAN 16CANDESARTAN CILEXETIL16 MGAJANTA PHARMA LIMITED-B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER30/05/2018
453NDA/MAL/HDP/8346AJANTA PHARMA LIMITEDABACUS PHARMA (AFRICA) LIMITEDADERAN 8CANDESARTAN CILEXETIL8MGAJANTA PHARMA LIMITED-B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER29/11/2017
454NDA/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 BLISTER01/07/2005
455NDA/MAL/HDP/4325AJANTA PHARMA LTD 31-0ABACUS PHARMA (AFRICA) LIMITEDACTINAC 100ACECLOFENAC100MGAJANTA PHARMA LIMITED-B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X2.0X10.0 TABLET BLISTER01/07/2009
456NDA/MAL/HDP/9062AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDADERAN 32CANDESARTAN CILEXETIL32 MGAJANTA PHARMA LIMITED-B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER26/09/2018
457NDA/MAL/HDP/8078AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDAPMOD 100/270ARTESUNATE + AMODIAQUINE100 MG + 270 MGAJANTA PHARMA LTD .-B-4//5/6, MIDC INDUSTRIALAREA, PAITHAN-431 128, AURANGBAD INDIAORAL SOLID ORDINARY LAYERED TABLETS1.0X6.0 TABLET BLISTER,1.0X3.0 TABLET BLISTER01/07/2011
458NDA/MAL/HDP/6392AJANTA PHARMA LIMITEDABACUS PHARMA (AFRICA) LIMITEDMET XL 50METOPROLOL SUCCINATE50 MGAJANTA PHARMA LTD .-B-4//5/6, MIDC INDUSTRIALAREA, PAITHAN-431 128, AURANGBAD INDIAORAL SOLID RETARD FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER30/05/2018
459NDA/MAL/HDP/2272AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDCLARANTA -500CLARITHROMYCIN500MGAJANTA PHARMA LTD .-B-4//5/6, MIDC INDUSTRIALAREA, PAITHAN-431 128, AURANGBAD INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X2.0X10.0 TABLET BLISTER01/07/2005
460NDA/MAL/HDP/3515AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDARTEFAN 40/240ARTEMETHER + LUMEFANTRINE40 MG + 40 MGAJANTA PHARMA LTD .-B-4//5/6, MIDC INDUSTRIALAREA, PAITHAN-431 128, AURANGBAD INDIAORAL SOLID ORDINARY TABLETS1.0X2.0X6.0 TABLET BLISTER,1.0X6.0 TABLET BLISTER (WITH AMFM LOGO),1.0X30.0X1.0X6.0 TABLET BLISTER (WITH AMFM LOGO),1.0X30.0X1.0X6.0 TABLET BLISTER (WITHOUT AMFM LOGO)01/07/2007
461NDA/MAL/HDP/0964AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDAPMOD 25 / 67.5ARTESUNATE + AMODIAQUINE25 MG + 67.5 MGAJANTA PHARMA LTD--B-4/5/6 MIDC INDUSTRIAL AREA PAITHAN 431 128 AURANGABADINDIAORAL SOLID ORDINARY LAYERED TABLETS1.0X1.0X3.0 TABLET BLISTER01/07/2013
462NDA/MAL/HDP/0963AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDAPMODARTESUNATE+AMODIAQUINE50MG+135MGAJANTA PHARMA LTD--B-4/5/6 MIDC INDUSTRIAL AREA PAITHAN 431 128 AURANGABADINDIAORAL SOLID ORDINARY LAYERED TABLETS1.0X3.0 TABLET BLISTER01/07/2013
463NDA/MAL/HDP/3702AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDATORFIT-20ATORVASTATIN20MGAJANTA PHARMA LTD--B-4/5/6 MIDC INDUSTRIAL AREA PAITHAN 431 128 AURANGABADINDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2005
464NDA/MAL/HDP/7451AKRITI PHARMACEUTICALS PVT LTDROYAL PHARMA 2011 LIMITEDMYTHRO 500AZITHROMYCIN DIHYDRATE500MGAKRITI PHARMACEUTICALS PVT LTD-PLOT NO. D-10 & 11, MIDC, JEJURI, TAL. PURANDAR, DIST. PUNE (MAHARASHTRA) INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X3.0 TABLET BLISTER28/11/2019
465NDA/MAL/HDP/7468AKRITI PHARMACEUTICALS PVT LTDROYAL PHARMA 2011 LIMITEDGYNO PLUSMETRONIDAZOLE + MICONAZOLE NITRATE100MG + 100MGAKRITI PHARMACEUTICALS PVT LTD-PLOT NO. D-10 & 11, MIDC, JEJURI, TAL. PURANDAR, DIST. PUNE (MAHARASHTRA) INDIA INDIAVAGINAL TABLETS1.0X1.0X10.0 TABLET BLISTER28/11/2019
466NDA/MAL/HDP/7470AKRITI PHARMACEUTICALS PVT LTDROYAL PHARMA 2011 LIMITEDAKSONECEFTRIAXONE SODIUM1GAKRITI PHARMACEUTICALS PVT LTD-PLOT NO. D-10 & 11, MIDC, JEJURI, TAL. PURANDAR, DIST. PUNE (MAHARASHTRA) INDIA INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0 G VIAL28/11/2019
467NDA/MAL/HDP/7476AKRITI PHARMACEUTICALS PVT LTDROYAL PHARMA 2011 LIMITEDAKRIDOL 12.5CARVEDILOL12.5 MGAKRITI PHARMACEUTICALS PVT LTD-PLOT NO. D-10 & 11, MIDC, JEJURI, TAL. PURANDAR, DIST. PUNE (MAHARASHTRA) INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER27/11/2019
468NDA/MAL/HDP/6090UNOSOURCE PHARMA LTDESCORTS PHARMACEUTICALS LIMITEDPROSTAR 200PROGESTERONE100MG/MLAKUMS DRUGS & PHARMACEUTICALS LTD .-47, 48 SECTOR 6A I.I.E SIDCUL RANIPUR HARIDWAR 249 403 INDIAPARENTERAL ORDINARY AMPOULES1.0X5.0X2.0 ML AMPOULE01/07/2017
469NDA/MAL/HDP/6289UNOSOURCE PHARMA LTDESCORTS PHARMACEUTICALS LIMITEDUNOPROG GELPROGESTERONE8.0% W/WAKUMS DRUGS & PHARMACEUTICALS LTD .-47, 48 SECTOR 6A I.I.E SIDCUL RANIPUR HARIDWAR 249 403 INDIAVAGINAL GELS AND SOLS1.0X1.0X1.0X1.125 G PREFILLED PEN17/12/2018
470NDA/MAL/HDP/6304UNOSOURCE PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDUNOSURE 72LEVONORGESTREL1.5MGAKUMS DRUGS & PHARMACEUTICALS LTD .-47, 48 SECTOR 6A I.I.E SIDCUL RANIPUR HARIDWAR 249 403 INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0 TABLET BLISTER28/03/2019
471NDA/MAL/HDP/8321UNOSOURCE PHARMA LTD.ABACUS PHARMA (AFRICA) LIMITEDPROSTAR- 200 CAPSULESPROGESTERONE200 MGAKUMS DRUGS & PHARMACEUTICALS LTD .-47, 48 SECTOR 6A I.I.E SIDCUL RANIPUR HARIDWAR 249 403 INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X3.0X10.0 CAPSULE BLISTER31/01/2018
472NDA/MAL/HDP/7912UNOSOURCE PHARMA LTD.ABACUS PHARMA (AFRICA) LIMITEDGLIMEWEL M-1GLIMEPIRIDE + METFORMIN HYDROCHLORIDE1MG + 500MGAKUMS DRUGS & PHARMACEUTICALS LTD --19,20,21, SECTOR 6A, I.I.E, SIDCUL, RANIPUR, HARIDWAR 249403 DISTRICT: UTTARAKHAND INDIA INDIAORAL SOLID ORDINARY LAYERED TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2017
473NDA/MAL/HDP/6681UNOSOURCE PHARMA LTD.ESCORTS PHARMACEUTICALS LIMITEDWELQUINELEVOFLOXACIN0.5%W/VAKUMS DRUGS & PHARMACEUTICALS LTD. -PLANT III, PLOT NO. 2, 3, 4 & 5, SECTOR 6-B, IIE, SIDCUL, RANIPUR,
HARIDWAR, UTTARAKHAND
INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X100.0 ML BOTTLE01/07/2016
474NDA/MAL/HDP/4370UNOSOURCE PHARMA LTDESCORTS PHARMACEUTICALS LIMITEDAKUMEROMEROPENEM1000 MGAKUMS DRUGS & PHARMACEUTICALS LTD. -PLANT III, PLOT NO. 2, 3, 4 & 5, SECTOR 6-B, IIE, SIDCUL, RANIPUR,
HARIDWAR, UTTARAKHAND
INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0 G VIAL07/01/2016
475NDA/MAL/HDP/6675UNOSOURCE PHARMA LTD.ABACUS PHARMA (AFRICA) LIMITEDUNOSEMIDE -10FUROSEMIDE10MG/MLAKUMS DRUGS & PHARMACEUTICALS LTD. -PLANT III,-PLOT NO. 2, 3, 4 & 5, SECTOR 6-B, IIE, SIDCUL,RANIPUR, 249 403
INDIAPARENTERAL ORDINARY AMPOULES1.0X10.0X2.0 ML AMPOULE01/07/2016
476NDA/MAL/HDP/0030UNOSOURCE PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDTRADMINTRAMADOL HYDROCHLORIDE50MG/MLAKUMS DRUGS & PHARMACEUTICALS LTD. -PLANT III,-PLOT NO. 2, 3, 4 & 5, SECTOR 6-B, IIE, SIDCUL,RANIPUR, 249 403
INDIAPARENTERAL ORDINARY AMPOULES1.0X5.0X2.0 ML AMPOULE01/07/2015
477NDA/MAL/HDP/6165UNOSOURCE PHARMA LTD.ESCORTS PHARMACEUTICALS LIMITEDCEFTRISONE - 1000CEFTRIAXONE SODIUM1G/VIALAKUMS DRUGS & PHARMACEUTICALS LTD. -PLANT III,-PLOT NO. 2, 3, 4 & 5, SECTOR 6-B, IIE, SIDCUL,RANIPUR, 249 403
INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0 G VIAL01/07/2016
478NDA/MAL/HDP/6167UNOSOURCE PHARMA LTD.ABACUS PHARMA (AFRICA) LIMITEDAKUROSEIRON SUCROSE20MG/MLAKUMS DRUGS & PHARMACEUTICALS LTD. -PLANT III,-PLOT NO. 2, 3, 4 & 5, SECTOR 6-B, IIE, SIDCUL,RANIPUR, 249 403
INDIAPARENTERAL ORDINARY INFUSION AMPOULES1.0X5.0X5.0 ML AMPOULE07/01/2016
479NDA/MAL/HDP/6641UNOSOURCE PHARMA LTD.ABACUS PHARMA (AFRICA) LIMITEDCEFTRISONE- S 1.5GCEFTRIAXONE SODIUM + SULBACTAM SODIUM1.0G + 0.5GAKUMS DRUGS & PHARMACEUTICALS LTD. -PLANT III,-PLOT NO. 2, 3, 4 & 5, SECTOR 6-B, IIE, SIDCUL,RANIPUR, 249 403
INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.5 G VIAL + 10ML WFI AMPOULE01/07/2016
480NDA/MAL/HDP/6577UNOSOURCE PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDCEFIWEL-200CEFIXIME200MGAKUMS DRUGS & PHARMACEUTICALS LTD..-19-20,21, SECTOR 6-4, SIDCUL, IIE, RANIPUR HARIDWAR-249403 INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER13/01/2020
481NDA/MAL/HDP/7740UNOSOURCE PHARMA LTD.ABACUS PHARMA (AFRICA) LIMITEDMETHICOWEL 1500METHYLCOBALAMIN1500 MCG/MLAKUMS DRUGS & PHARMACEUTICALS LTD.-2, 3, 4, & 5, SEC-6B, I.I.E., SIDCUL, RANIPUR, HARIDWAR-249403 (INDIA INDIAPARENTERAL ORDINARY AMPOULES1.0X5.0X1.0 ML AMPOULE01/07/2017
482NDA/MAL/HDP/7747UNOSOURCE PHARMA LTD.ESCORTS PHARMACEUTICALS LIMITEDTHERMODOLPARACETAMOL1.0%W/VAKUMS DRUGS & PHARMACEUTICALS LTD.-2, 3, 4, & 5, SEC-6B, I.I.E., SIDCUL, RANIPUR, HARIDWAR-249403 (INDIA INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X100.0 ML BOTTLE01/07/2017
483NDA/MAL/HDP/8103UNOSOURCE PHARMA LTD.ABACUS PHARMA (AFRICA) LIMITEDWELQUINE 500LEVOFLOXACIN500MGAKUMS DRUGS & PHARMACEUTICALS LTD.-PLANT III, PLOT NO. 19, 20, 21, SECTOR 6-A, IIE, SIDCUL, RANIPUR, DISTRICT: UTTARAKHAND INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER01/07/2016
484NDA/MAL/HDP/7695UNOSOURCE PHARMA LTD.ESCORTS PHARMACEUTICALS LIMITEDCORTUM 500CEFUROXIME AXETIL500MGAKUMS DRUGS & PHARMACEUTICALS LTD.-PLANT III, PLOT NO. 19, 20, 21, SECTOR 6-A, IIE, SIDCUL, RANIPUR, DISTRICT: UTTARAKHAND INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2017
485NDA/MAL/HDP/6086UNOSOURCE PHARMA LTDESCORTS PHARMACEUTICALS LIMITEDACEWEL-PACECLOFENAC+PARACETAMOL100MG+500MGAKUMS DRUGS & PHARMACEUTICALS LTD-19, 20,21 SECTOR 6A IIE SIDCUL RANIPUR HARIDWAR 249 403 INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER01/07/2017
486NDA/MAL/HDP/8356UNOSOURCE PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDLORFACT-DDESLORATIDINE5MG,AKUMS DRUGS & PHARMACEUTICALS LTD-19, 20,21 SECTOR 6A IIE SIDCUL RANIPUR HARIDWAR 249 403 INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER29/11/2017
487NDA/MAL/HDP/4318UNOSOURCE PHARMA LTD.ESCORTS PHARMACEUTICALS LIMITEDAKUGABALINPREGABALIN75 MGAKUMS DRUGS & PHARMACEUTICALS LTD-19, 20,21 SECTOR 6A IIE SIDCUL RANIPUR HARIDWAR 249 403 INDIAORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER07/01/2016
488NDA/MAL/HDP/6141UNOSOURCE PHARMA LTDESCORTS PHARMACEUTICALS LIMITEDACEWELACECLOFENAC100MGAKUMS DRUGS & PHARMACEUTICALS LTD-19, 20,21 SECTOR 6A IIE SIDCUL RANIPUR HARIDWAR 249 403 INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER01/07/2016
489NDA/MAL/HDP/6036UNOSOURCE PHARMA LTD.ABACUS PHARMA (AFRICA) LIMITEDOFLOTECH-OOFLOXACIN + ORNIDAZOLE200MG + 500MGAKUMS DRUGS & PHARMACEUTICALS LTD-19-20,21, SECTOR 6-4, SIDCUL, IIE, RANIPUR HARIDWAR-249403 INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER28/03/2019
490NDA/MAL/HDP/8418UNOSOURCE PHARMA LTD.ABACUS PHARMA (AFRICA) LIMITEDCLOPIDOWEL 75CLOPIDOGREL75MGAKUMS DRUGS & PHARMACEUTICALS LTD-19-20,21, SECTOR 6-4, SIDCUL, IIE, RANIPUR HARIDWAR-249403 INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER13/01/2020
491NDA/MAL/HDP/8564UNOSOURCE PHARMA LTD.ABACUS PHARMA (AFRICA) LIMITEDFINAMAXFINASTERIDE5MGAKUMS DRUGS & PHARMACEUTICALS LTD-19-20,21, SECTOR 6-4, SIDCUL, IIE, RANIPUR HARIDWAR-249403 INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER13/01/2020
492NDA/MAL/HDP/6579UNOSOURCE PHARMA LTD.ABACUS PHARMA (AFRICA) LIMITEDPLENCOXIB 200CELECOXIB200 MGAKUMS DRUGS & PHARMACEUTICALS LTD-PLANT II, PLOT NO. 22, SECTOR- 6A, IIE, SIDCUL, RANIPUR, DISTT.: HARIDWAR, UTTARAKHAND INDIAORAL SOLID ORDINARY CAPSULES1.0X6.0X10.0 CAPSULE BLISTER28/08/2019
493NDA/MAL/HDP/8566UNOSOURCE PHARMA LTD.ABACUS PHARMA (AFRICA) LIMITEDAZINOWELAZITHROMYCIN200MG/5MLAKUMS DRUGS & PHARMACEUTICALS LTD-PLANT II, PLOT NO. 22, SECTOR- 6A, IIE, SIDCUL, RANIPUR, DISTT.: HARIDWAR, UTTARAKHAND INDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X15.0 ML BOTTLE29/11/2019
494NDA/MAL/HDP/7751UNOSOURCE PHARMA LTD.ABACUS PHARMA (AFRICA) LIMITEDUNODEX COUGH SYRUPBROMHEXINE HYDROCHLORIDE + DEXTROMETHORPHAN HYDROBROMIDE + AMMONIUM CHLORIDE8MG + 10MG + 100MGAKUMS DRUGS & PHARMACEUTICALS LTD-PLANT II-PLOT NO.22, SECTOR 6-A, IIE, SIDCUL, RANIPUR,DISTRICT: HARIDWAR 249 403, INDIA INDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE01/07/2017
495NDA/MAL/HDP/8648UNOSOURCE PHARMA LTD.ABACUS PHARMA (AFRICA) LIMITEDUNODEX PLUSTERBUTALINE SULPHATE + BROMHEXINE HYDROCHLORIDE + GUAIFENESIN2.5MG + 8MG + 100MGAKUMS DRUGS & PHARMACEUTICALS LTD-PLANT II-PLOT NO.22, SECTOR 6-A, IIE, SIDCUL, RANIPUR,DISTRICT: HARIDWAR 249 403, INDIA INDIAORAL LIQUID ORDINARY SYRUPS1.0X1.0X100.0 ML BOTTLE28/03/2018
496NDA/MAL/HDP/8819UNOSOURCE PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDLORFACT-D SYRUPDESLORATADINE5MG/5MLAKUMS DRUGS & PHARMACEUTICALS LTD-PLANT II-PLOT NO.22, SECTOR 6-A, IIE, SIDCUL, RANIPUR,DISTRICT: HARIDWAR 249 403, INDIA INDIAORAL LIQUID ORDINARY SYRUPS1.0X1.0X100.0 ML BOTTLE30/05/2018
497NDA/MAL/HDP/7098UNOSOURCE PHARMA LTD.ABACUS PHARMA (AFRICA) LIMITEDACEFORCE SPACECLOFENAC+PARACETAMOL+SERRATIOPEPTIDASE100MG+325MG+15MGAKUMS DRUGS AND PHARMACEUTICALS LTD-PLANT-1 PLOT NO.19, 20&21 SECTOR-6A, 11E, SIDCUL, RAHIPUR DISTT; HARIDWAR, 249403, (UTTRAKHAND) INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER31/01/2018
498NDA/MAL/HDP/7123UNOSOURCE PHARMA LTD.ESCORTS PHARMACEUTICALS LIMITEDMARTINEZ 10MONTELUKAST SODIUM10MGAKUMS DRUGS AND PHARMACEUTICALS LTD-PLANT-1 PLOT NO.19, 20&21 SECTOR-6A, 11E, SIDCUL, RAHIPUR DISTT; HARIDWAR, 249403, (UTTRAKHAND) INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER28/03/2018
499NDA/MAL/HDP/8105UNOSOURCE PHARMA LTD.ABACUS PHARMA (AFRICA) LIMITEDXERINLEVOCETIRIZINE HYDROCHLORIDE + MONTELUKAST SODIUM5MG + 10MGAKUMS DRUGS AND PHARMACEUTICALS LTD-PLANT-1 PLOT NO.19, 20&21 SECTOR-6A, 11E, SIDCUL, RAHIPUR DISTT; HARIDWAR, 249403, (UTTRAKHAND) INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2017
500NDA/MAL/HDP/6181UNOSOURCE PHARMA LTD.ABACUS PHARMA (AFRICA) LIMITEDAZINOWEL-500AZITHROMYCIN500MGAKUMS DRUGS AND PHARMACEUTICALS LTD-PLANT-1 PLOT NO.19, 20&21 SECTOR-6A, 11E, SIDCUL, RAHIPUR DISTT; HARIDWAR, 249403, (UTTRAKHAND) INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0 TABLET BLISTER01/07/2016
501NDA/MAL/HDP/6669UNOSOURCE PHARMA LTD.ABACUS PHARMA (AFRICA) LIMITEDSUPER WELGRA -100SILDENAFIL CITRATE + DAPOXETINE HYDROCHLORIDE100MG + 60MGAKUMS DRUGS AND PHARMACEUTICALS LTD-PLANT-1 PLOT NO.19, 20&21 SECTOR-6A, 11E, SIDCUL, RAHIPUR DISTT; HARIDWAR, 249403, (UTTRAKHAND) INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X4.0 TABLET BLISTER01/07/2016
502NDA/MAL/HDP/4738NORVATIS PHARMA AG- SWITZERLANDLABOREX UGANDA LIMITEDCILOXANCIPROFLOXACIN0.3%W/VALCON -ALCON COUVREUR NV B-2870 PUURS BELGIUMBELGIUMOPHTHALMIC DROPS1.0X5.0 ML BOTTLE01/07/1997
503NDA/MAL/HDP/1738ALCON PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.TEARS NATURALE IINATURAL TEARS15MLALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUM BELGIUMOPHTHALMIC DROPS1.0X15.0 ML BOTTLE01/07/1997
504NDA/MAL/HDP/0572NORVATIS PHARMA AG- SWITZERLANDLABOREX UGANDA LIMITEDAZARGABRINZOLAMIDE + TIMOLOL10MG/ML + 5MG/MLALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUM BELGIUMOPHTHALMIC DROPS1.0X5.0 ML VIAL01/07/2010
505NDA/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 VIAL01/07/2009
506NDA/MAL/HDP/2545NORVATIS PHARMA AG- SWITZERLANDLABOREX UGANDA LIMITEDTOBREXTOBRAMYCIN0.3%W/VALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUM BELGIUMOPHTHALMIC DROPS1.0X5.0 ML BOTTLE01/07/1997
507NDA/MAL/HDP/2974NORVATIS PHARMA AG- SWITZERLANDLABOREX UGANDA LIMITEDTRAVATANTRAVOPROST4µG/MLALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUM BELGIUMOPHTHALMIC DROPS1.0X2.5 ML VIAL01/07/2009
508NDA/MAL/HDP/3331NORVATIS PHARMA AG- SWITZERLANDLABOREX UGANDA LIMITEDBETOPTICBETAXOLOLO.5%W/VALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUM BELGIUMOPHTHALMIC DROPS1.0X5.0 ML VIAL01/07/1997
509NDA/MAL/HDP/4060NORVATIS PHARMA AG- SWITZERLANDLABOREX UGANDA LIMITEDTOBRADEXTOBRAMYCIN/DEXAMETHASONE0.3%W/V+ 0.1%W/VALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUM BELGIUMOPHTHALMIC DROPS1.0X5.0 ML BOTTLE01/07/1997
510NDA/MAL/HDP/4650NORVATIS PHARMA AG- SWITZERLANDLABOREX UGANDA LIMITEDDUOTRAVTRAVOPROST + TIMOLOL MALEATE40MG/ML + 5MG/MLALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUM BELGIUMOPHTHALMIC DROPS1.0X1.0X2.5 ML VIAL01/07/2010
511NDA/MAL/HDP/4927NORVATIS PHARMA AG- SWITZERLANDLABOREX UGANDA LIMITEDAZOPTBRINZOLAMIDE10MG/MLALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUM BELGIUMOPHTHALMIC SUSPENSIONS1.0X5.0 ML BOTTLE01/07/2009
512NDA/MAL/HDP/5041NORVATIS PHARMA AG- SWITZERLANDLABOREX UGANDA LIMITEDMAXITROLDEXAMETHASONE/NEOMYCIN/POLYMYXIN B0.1%W/W +0.1%W/W+6000 I.UALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUM BELGIUMOPHTHALMIC OINTMENTS1.0X3.5 G TUBE01/07/1997
513NDA/MAL/HDP/5043NORVATIS PHARMA AG- SWITZERLANDLABOREX UGANDA LIMITEDMAXITROLDEXAMETHASONE/NEOMYCIN/POLYMYXIN B0.1%W/W+3500I.U/ML+6000I.U/MLALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUM BELGIUMOPHTHALMIC DROPS1.0X5.0 ML BOTTLE01/07/1997
514NDA/MAL/HDP/5050NORVATIS PHARMA AG- SWITZERLANDLABOREX UGANDA LIMITEDMAXIDEXDEXAMETHASONE0.1%W/VALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUM BELGIUMOPHTHALMIC DROPS1.0X5.0 ML BOTTLE01/07/1997
515NDA/MAL/HDP/4321NORVATIS PHARMA AG- SWITZERLANDLABOREX UGANDA LIMITEDCUSIMOLOL 0.5%TIMOLOL MALEATE0.5% W/VALCON CUSI S.A .-CAMIL FABRA,58 08320 EL MASNOU BARCELONA SPAIN SPAINOPHTHALMIC DROPS1.0X5.0 ML VIAL01/07/2000
516NDA/MAL/HDP/4326NORVATIS PHARMA AG- SWITZERLANDLABOREX UGANDA LIMITEDCUSICROM 4% EYE DROPSSODIUM CROMOGLYCATE4 %W/VALCON CUSI S.A .-CAMIL FABRA,58 08320 EL MASNOU BARCELONA SPAIN SPAINOPHTHALMIC DROPS1.0X10.0 ML VIAL01/07/2002
517NDA/MAL/HDP/2961NORVATIS PHARMA AG- SWITZERLANDLABOREX UGANDA LIMITEDOFTALMOLOSA CUSI ERYTHROMYCIN 0.5%ERYTHROMYCIN0.5%W/WALCON CUSI SA-CAMIL FABRA 58 08320 EL MASNOUR BARCELONASPAINOPHTHALMIC OINTMENTS1.0X3.5 G TUBE01/07/2001
518NDA/MAL/HDP/8935AL-FAZAL PHARMA INDUSTRIES (PVT.) LTDHEALTHCARE LTD.FECLO GELDICLOFENAC DIETHYLAMMONIUM SALT1%W/WAL-FAZAL PHARMA INDUSTRIES (PVT.) LTD-PLOT 20,21,22- DEFENCE INDUSTRIAL ZONE-MOMAN PURA, 16KM SHEIKHUPURA ROAD, (LAHORE) - PAKISTAN PAKISTANTOPICAL EXTERNAL EMULSION GELS1.0X1.0X20.0 G TUBE,1.0X1.0X15.0 G TUBE25/07/2018
519NDA/MAL/HDP/8936AL-FAZAL PHARMA INDUSTRIES (PVT.) LTDHEALTHCARE LTD.ESOFOLEESOMEPRAZOLE MAGNESIUM TRIHYDRATE40MGAL-FAZAL PHARMA INDUSTRIES (PVT.) LTD-PLOT 20,21,22- DEFENCE INDUSTRIAL ZONE-MOMAN PURA, 16KM SHEIKHUPURA ROAD, (LAHORE) - PAKISTAN PAKISTANORAL SOLID ORDINARY CAPSULES1.0X2.0X7.0 CAPSULE BLISTER25/07/2018
520NDA/MAL/HDP/7706CACHET PHARMACEUTICALS PVT LIMITEDASTRA PHARMA (U) LIMITEDCACEF 200CEFPODOXIME PROXETIL200MGALKEM LABORATORIES LIMITED -VILLAGE- THANA BADDI, YEH
NALAGAR, DISTRICT SOLAN, HIMACHAL PRADESH
INDIA
INDIAORAL SOLID ORDINARY TABLETS1.0X6.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER01/07/2017
521NDA/MAL/HDP/3616: ALKEM LABORATORIES LIMITED?ABACUS PHARMA (AFRICA) LIMITEDZAXTERMEROPENEM1GALKEM LABORATORIES LIMITED.-VILLAGE THANA, BADDI, TEHSIL-NALAGARH, DISTT-SOLAN, (HP), INDIA-173205 INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0 G VIAL01/07/2011
522NDA/MAL/HDP/3685GALPHAR LABORATORIES LTDAIVEEN (U) LIMITEDODICEFCEFTRIAXONE1GALKEM LABORATORIES LIMITED.-VILLAGE THANA, BADDI, TEHSIL-NALAGARH, DISTT-SOLAN, (HP), INDIA-173205 INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0 G VIAL01/07/2013
523NDA/MAL/HDP/4577ALKEM LABORATORIES LIMITEDABACUS PHARMA (AFRICA) LIMITEDMAGTAMCEFOPERAZONE + SULBACTAM500 MG + 500 MGALKEM LABORATORIES LIMITED.-VILLAGE THANA, BADDI, TEHSIL-NALAGARH, DISTT-SOLAN, (HP), INDIA-173205 INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0 G VIAL01/07/2011
524NDA/MAL/HDP/4677: ALKEM LABORATORIES LIMITED?ABACUS PHARMA (AFRICA) LIMITEDZOCEFCEFUROXIME125MG/5MLALKEM LABORATORIES LIMITED.-VILLAGE THANA, BADDI, TEHSIL-NALAGARH, DISTT-SOLAN, (HP), INDIA-173205 INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X1.0X30.0 ML BOTTLE,1.0X70.0 ML BOTTLE01/07/2011
525NDA/MAL/HDP/4678: ALKEM LABORATORIES LIMITED?ABACUS PHARMA (AFRICA) LIMITEDZOCEF-500CEFUROXIME AXETIL500MGALKEM LABORATORIES LIMITED.-VILLAGE THANA, BADDI, TEHSIL-NALAGARH, DISTT-SOLAN, (HP), INDIA-173205 INDIAORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER01/07/2009
526NDA/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 BLISTER01/07/2009
527NDA/MAL/HDP/3948: ALKEM LABORATORIES LIMITED?ABACUS PHARMA (AFRICA) LIMITEDTAXIM-OCEFIXIME50MG/5MLALKEM 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 LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE01/07/2009
528NDA/MAL/HDP/0521ALKEM LABORATORIES LIMITEDABACUS PHARMA (AFRICA) LIMITEDPAN 40PANTOPRAZOLE SODIUM40MGALKEM LABORATORIES LTD .- VILLAGE THANA BADDI TEHSIL NALAGARH DIST SOLAN HIMACHAL PRADESHINDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER01/07/2014
529NDA/MAL/HDP/7383ALKEM LABORATORIES LIMITEDABACUS PHARMA (AFRICA) LIMITEDOLKEM 20OLMESARTAN MEDOXOMIL20MGALKEM LABORATORIES LTD .,.-VILLAGE THANA BADDI DIST-SOLAN TEHSIL NALAGARH HIMACHAL PRADESH 173205 INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER28/11/2019
530NDA/MAL/HDP/3310ALKEM LABORATORIES LIMITEDABACUS PHARMA (AFRICA) LIMITEDGEMFOSRISEDRONATE SODIUM35MGALKEM LABORATORIES LTD .,.-VILLAGE THANA BADDI DIST-SOLAN TEHSIL NALAGARH HIMACHAL PRADESH 173205 INDIAORAL SOLID ORDINARY TABLETS1.0X4.0 TABLET BLISTER01/07/2011
531NDA/MAL/HDP/1954: ALKEM LABORATORIES LIMITED?ABACUS PHARMA (AFRICA) LIMITEDRAPEED-20RABEPRAZOLE20MGALKEM LABORATORIES LTD .-VILLAGE THANA, BADDI, TEHSIL-NALAGARH, DISTT-SOLAN, (HP), INDIA-173205 INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET STRIP,1.0X1.0X10.0 TABLET STRIP01/07/2011
532NDA/MAL/HDP/8485CACHET PHARMACEUTICALS PVT LIMITEDASTRA PHARMA (U) LIMITEDTRIAXONCEFIXIME400MGALKEM LABORATORIES LTD .-VILLAGE THANA, BADDI, TEHSIL-NALAGARH, DISTT-SOLAN, (HP), INDIA-173205 INDIAORAL SOLID ORDINARY COATED TABLETS1.0X10.0 TABLET BLISTER31/01/2018
533NDA/MAL/HDP/8495CACHET PHARMACEUTICALS PRIVATE LIMITEDASTRA PHARMA (U) LIMITEDCACEF 50CEFPODOXIME PROXETIL USP50MG / 5MLALKEM LABORATORIES LTD.-VILLAGE THANA, BADDI, DISTT. SOLAN,HIMACHAL PRADESH 173205 INDIA. INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X30.0 ML BOTTLE31/01/2018
534NDA/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 VIAL01/07/2011
535NDA/MAL/HDP/8344CACHET PHARMACEUTICALS PRIVATE LIMITEDASTRA PHARMA (U) LIMITEDCELZA DRY SYRUPCEFUROXIME AXETIL USP125 MG/5 MLALKEM LABORATORIES LTD--PURANA BARRIER, VILLAGE THANA, BADDI, DISTT. SOLAN, HIMACHAL PRADESH INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X50.0 ML BOTTLE29/11/2017
536NDA/MAL/HDP/8345CACHET PHARMACEUTICALS PRIVATE LIMITEDASTRA PHARMA (U) LIMITEDCELZA 500CEFUROXIME AXETIL USP500 MGALKEM LABORATORIES LTD--PURANA BARRIER, VILLAGE THANA, BADDI, DISTT. SOLAN, HIMACHAL PRADESH INDIAORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER29/11/2017
537NDA/MAL/HDP/1088GALPHA LABORATORIES LTDAIVEEN (U) LIMITEDRESTUMCEFUROXIME SODIUM750MGALKEM LABORATORIES LTD-VILLAGE – THANA, BADDI TEHSIL – NALAGARH, DIST-SOLAN (HP), INDIA – 173205 INDIAPARENTERAL ORDINARY DRY VIALS1.0X750.0 MG VIAL01/07/2015
538NDA/MAL/HDP/1187GALPHA LABORATORIES LTDAIVEEN (U) LIMITEDKEFTAZ-1000CEFTAZIDIME1 GALKEM LABORATORIES LTD-VILLAGE – THANA, BADDI TEHSIL – NALAGARH, DIST-SOLAN (HP), INDIA – 173205 INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0X1.0 G VIAL + 1*10 ML WATER FOR INJECTION01/07/2013
539NDA/MAL/HDP/1345ALKEM LABORATORIES LIMITEDABACUS PHARMA (AFRICA) LIMITEDSWICH-200CEFPODOXIME200MGALKEM LABORATORIES LTD-VILLAGE – THANA, BADDI TEHSIL – NALAGARH, DIST-SOLAN (HP), INDIA – 173205 INDIAORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER01/07/2010
540NDA/MAL/HDP/8087ALKEM LABORATORIES LIMITEDABACUS PHARMA (AFRICA) LIMITEDONDEM INJECTION 4MG/2MLONDANSETRON4MG/2MLALKEM LABORATORIES LTD-VILLAGE – THANA, BADDI TEHSIL – NALAGARH, DIST-SOLAN (HP), INDIA – 173205 INDIAPARENTERAL ORDINARY AMPOULES1.0X10.0X2.0 ML AMPOULE01/07/2011
541NDA/MAL/HDP/8088ALKEM LABORATORIES LIMITEDABACUS PHARMA (AFRICA) LIMITEDONDEM INJECTION 8MG/4MLONDANSETRON8MG/4MLALKEM LABORATORIES LTD-VILLAGE – THANA, BADDI TEHSIL – NALAGARH, DIST-SOLAN (HP), INDIA – 173205 INDIAPARENTERAL ORDINARY AMPOULES1.0X10.0X4.0 ML AMPOULE01/07/2011
542NDA/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 WFI01/07/2013
543NDA/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 WFI01/07/2013
544NDA/MAL/HDP/7371ALKEM LABORATORIES LIMITEDABACUS PHARMA (AFRICA) LIMITEDOLKEM 40OLMESARTAN MEDOXOMIL40MGALKEM LABS LTD.-VILLAGE THANA, BADDI, THE NALAGARH, DIST SOLAN (HP) 173205 INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER28/11/2019
545NDA/MAL/HDP/7491DENK PHARMA GMBH & COBENLE CONSULT LIMITEDCIPRO-DENK 750CIPROFLOXACIN HYDROCHLORIDE750MGALLPHAMED PHARBIL ARZNEIMITTEL GMBH. -HILDEBRANDSTRABE 12 37081 GOTTINGENGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER01/07/2017
546NDA/MAL/HDP/2212DENK PHARMABENLE CONSULT LIMITEDCIPRO-DENK 500CIPROFLOXACIN500MGALLPHARMED PHARBIL ARZNEIMITTEL GMBH-12 D377081GERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER01/07/2005
547NDA/MAL/HDP/7079MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDBENDAMUSTINEBENDAMUSTINE HYDROCHLORIDE100MGALLY PHARMA OPTIONS PVT LTD..-J-7, MIDC, TARAPUR INDUSTRIAL AREA,
BOISAR, DIST-THANE
INDIAPARENTERAL ORDINARY DRY VIALS1.0X50.0 ML VIAL13/01/2020
548NDA/MAL/HDP/7081MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDBENDAMUSTINEBENDAMUSTINE HYDROCHLORIDE25MG/VIALALLY PHARMA OPTIONS PVT LTD..-J-7, MIDC, TARAPUR INDUSTRIAL AREA,
BOISAR, DIST-THANE
INDIAPARENTERAL ORDINARY DRY VIALS1.0X20.0 ML VIAL13/01/2020
549NDA/MAL/HDP/7727AMANTA HEALTHCARE LTDPHARMA VILLE LIMITEDRINGER LACTATECOMPOUND SODIUM LACTATEMULTI-INGREDIENTAMANTA HEALTHCARE LIMITED (FORMERLY KNOWN AS MARCK BIOSCIENCES LTD)-PLOT NO. 876, N.H. NO. 8, VILLAGE - HARIYALA, DIST - KHEDA 387411, GUJARAT INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X500.0 ML BOTTLE01/07/2017
550NDA/MAL/HDP/2877AMANTA HEALTHCARE LTDPHARMA VILLE LIMITEDCANDICANFLUCONAZOLE0.2%W/VAMANTA HEALTHCARE LIMITED (FORMERLY KNOWN AS MARCK BIOSCIENCES LTD)-PLOT NO. 876, N.H. NO. 8, VILLAGE - HARIYALA, DIST - KHEDA 387411, GUJARAT INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X100.0 ML BOTTLE01/07/2005
551NDA/MAL/HDP/1150AMANTA HEALTHCARE LTDPHARMA VILLE LIMITEDFEBRAMOLPARACETAMOL INFUSION10MG/MLAMANTA HEALTHCARE LIMITED (FORMERLY KNOWN AS MARCK BIOSCIENCES LTD)-PLOT NO. 876, N.H. NO. 8, VILLAGE - HARIYALA, DIST - KHEDA 387411, GUJARAT INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X100.0 ML BOTTLE01/07/2013
552NDA/MAL/HDP/2742AMANTA HEALTHCARE LTDPHARMA VILLE LIMITEDSTERILIZED WATER FOR INJECTION BPSTERILIZED WATER FOR INJECTION BPMULTI-INGREDIENTAMANTA HEALTHCARE LIMITED (FORMERLY KNOWN AS MARCK BIOSCIENCES LTD)-PLOT NO. 876, N.H. NO. 8, VILLAGE - HARIYALA, DIST - KHEDA 387411, GUJARAT INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X10.0X5.0X10.0 ML BOTTLE
553NDA/MAL/HDP/3394AMANTA HEALTHCARE LTDPHARMA VILLE LIMITEDMAGNESIUM SULPHATEMAGNESIUM SULPHATE50%W/VAMANTA HEALTHCARE LIMITED (FORMERLY KNOWN AS MARCK BIOSCIENCES LTD)-PLOT NO. 876, N.H. NO. 8, VILLAGE - HARIYALA, DIST - KHEDA 387411, GUJARAT INDIAPARENTERAL ORDINARY AMPOULES1.0X50.0X10.0 ML AMPOULE01/07/2010
554NDA/MAL/HDP/4633AMANTA HEALTHCARE LTDPHARMA VILLE LIMITEDMETRONIDAZOLE INFUSIONMETRONIDAZOLE5MG/MLAMANTA HEALTHCARE LIMITED (FORMERLY KNOWN AS MARCK BIOSCIENCES LTD)-PLOT NO. 876, N.H. NO. 8, VILLAGE - HARIYALA, DIST - KHEDA 387411, GUJARAT INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X100.0 ML BOTTLE01/07/2014
555NDA/MAL/HDP/6149AMANTA HEALTHCARE LTDPHARMA VILLE LIMITEDSODIUM CHLORIDE INFUSIONSODIUM CHLORIDE0.9%W/VAMANTA HEALTHCARE LIMITED (FORMERLY KNOWN AS MARCK BIOSCIENCES LTD)-PLOT NO. 876, N.H. NO. 8, VILLAGE - HARIYALA, DIST - KHEDA 387411, GUJARAT INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X500.0 ML BOTTLE01/07/2016
556NDA/MAL/HDP/6204AMANTA HEALTHCARE LTDPHARMA VILLE LIMITEDGLUCOSE 5% I.VGLUCOSE5%W/VAMANTA HEALTHCARE LIMITED (FORMERLY KNOWN AS MARCK BIOSCIENCES LTD)-PLOT NO. 876, N.H. NO. 8, VILLAGE - HARIYALA, DIST - KHEDA 387411, GUJARAT INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X500.0 ML BOTTLE01/07/2016
557NDA/MAL/HDP/0866GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDLIZOLIDLINEZOLID2MG/MLAMANTA HEALTHCARE LIMITED-PLOT NO. 876 N.H. NO. 8 VILLAGE-HIRIYALA TALUKA, MATAR, DIST KHEDA-387 411, GUJARAT INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X300.0 ML BOTTLE,1.0X100.0 ML BOTTLE01/07/2013
558NDA/MAL/HDP/4099GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDGLEVO I.VLEVOFLOXACIN500MG/100MLAMANTA HEALTHCARE LIMITED-PLOT NO. 876 N.H. NO. 8 VILLAGE-HIRIYALA TALUKA, MATAR, DIST KHEDA-387 411, GUJARAT INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X100.0 ML BOTTLE01/07/2007
559NDA/MAL/HDP/7510AMMAN PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDIMAVIR EYE OINTMENTACYCLOVIR3%AMMAN PHARMACEUTICAL INDUSTRIES-KING ABDULLAH II, INDUSTRIAL ESTATE,
SAHAB, AMMAN, JORDAN

MMAN, JORDAN
JORDANOPHTHALMIC OINTMENTS1.0X5.0 G TUBE29/05/2019
560NDA/MAL/HDP/1741AMMAN PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDNEOPRED-PPREDNISOLONE ACETATE + NEOMYCIN SULPHATE+ POLYMYXIN-B5MG/ML +5MG/ML + 1M I.U/MLAMMAN PHARMACEUTICALS INDUSTRIES .-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDAN JORDANOPHTHALMIC DROPS1.0X1.0X10.0 ML VIAL01/07/2005
561NDA/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 VIAL01/07/2005
562NDA/MAL/HDP/1758AMMAN PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDAPICORTPREDNISOLONE ACETATE0.12%W/VAMMAN PHARMACEUTICALS INDUSTRIES .-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDAN JORDANOPHTHALMIC DROPS1.0X1.0X10.0 ML VIAL01/07/2005
563NDA/MAL/HDP/1762AMMAN PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDAPITROPINATROPINE1%W/VAMMAN PHARMACEUTICALS INDUSTRIES .-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDAN JORDANOPHTHALMIC DROPS1.0X1.0X10.0 ML VIAL01/07/2005
564NDA/MAL/HDP/1754AMMAN PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDAPIMOLTIMOLOL MALEATE0.5%W/VAMMAN PHARMACEUTICALS INDUSTRIES .-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDAN JORDANOPHTHALMIC DROPS1.0X1.0X5.0 ML VIAL01/07/2005
565NDA/MAL/HDP/1751AMMAN PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDOPTIFUCINFUSIDIC ACID1%W/VAMMAN PHARMACEUTICALS INDUSTRIES .-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDAN JORDANOPHTHALMIC DROPS1.0X5.0 ML AMPOULE01/07/2005
566NDA/MAL/HDP/1745AMMAN PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDAPIGENGENTAMYCIN SULPHATE0.3%W/VAMMAN PHARMACEUTICALS INDUSTRIES-AMMAN PHARMACEUTICAL INDUSTRIES-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDAN JORDANOPHTHALMIC DROPS1.0X1.0X10.0 ML VIAL01/07/2005
567NDA/MAL/HDP/1750AMMAN PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDAPIFLOXNORFLOXACIN0.3%W/VAMMAN PHARMACEUTICALS INDUSTRIES-AMMAN PHARMACEUTICAL INDUSTRIES-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDAN JORDANOPHTHALMIC DROPS1.0X1.0X10.0 ML VIAL01/07/2005
568NDA/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 VIAL01/07/2005
569NDA/MAL/HDP/6408AMMAN PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDDECOZALXYLOMETAZOLINE HCL0.1%W/VAMMAN PHARMACEUTICALS INDUSTRIES-KING ABDULLAH II, INDUSTRIAL ESTATE, SAHAB, AMMAN JORDANNASAL TOPICAL METERED DOSE AEROSOLS1.0X10.0 ML BOTTLE29/05/2019
570NDA/MAL/HDP/7483AMMAN PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDAPISOPT PLUSDORZOLAMIDE HYDROCHLORIDE + TIMOLOL MALEATE2%W/V + 0.5%W/VAMMAN PHARMACEUTICALS INDUSTRIES-KING ABDULLAH II, INDUSTRIAL ESTATE, SAHAB, AMMAN JORDANOPHTHALMIC LIQUIDS1.0X5.0 ML VIAL27/11/2019
571NDA/MAL/HDP/7524AMMAN PHARMACEUTICALS LTDWIDE SPECTRUM ENTERPRISES (U) LIMITEDLOPROSTANLATANOPROST + TIMOLOL MALEATE0.005% W/V + 0.5%W/VAMMAN PHARMACEUTICALS INDUSTRIES-KING ABDULLAH II, INDUSTRIAL ESTATE, SAHAB, AMMAN JORDANOPHTHALMIC LIQUIDS1.0X2.5 ML VIAL27/11/2019
572NDA/MAL/HDP/7595AMMAN PHARMACEUTICALS LTDWIDE SPECTRUM ENTERPRISES (U) LIMITEDLOPROSTLATANOPROST0.005% W/VAMMAN PHARMACEUTICALS INDUSTRIES-KING ABDULLAH II, INDUSTRIAL ESTATE, SAHAB, AMMAN JORDANOPHTHALMIC VIALS1.0X2.5 ML VIAL27/11/2019
573NDA/MAL/HDP/3798AMOUN PHARMACEUTICAL COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDNEUROTON TABLETMULTI-INGREDIENTN/AAMOUN PHARMACETICAL COMPANY-1ST INDUSTRIAL ZONE, EL OBOUR CITY, CAIRO, EGYPT EGYPTORAL SOLID ORDINARY COATED TABLETS1.0X2.0X10.0 TABLET BLISTER01/07/2004
574NDA/MAL/HDP/1227AMOUN PHARMACEUTICALS COMPANYBOOTS PHARMACEUTICALS LIMITEDFUNGISAFETERBINAFINE HCL250MGAMOUN PHARMACEUTICAL CO. S.A.E-1ST INDUSTRIAL ZONE A, PLOTS NO. 1B,2,3,4,5 BLOCK 13015, EL-OBOUR CITY,
KALYOUBIA CAIRO EGYPT
EGYPTORAL SOLID ORDINARY FILM-COATED TABLETS1.0X7.0 TABLET STRIP01/07/2013
575NDA/MAL/HDP/6191AMOUN PHARMACEUTICALS COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDKAPRON AMPOULETRANEXAMIC ACID500MG/5MLAMOUN PHARMACEUTICAL CO. S.A.E-1ST INDUSTRIAL ZONE A, PLOTS NO. 1B,2,3,4,5 BLOCK 13015, EL-OBOUR CITY,
KALYOUBIA CAIRO EGYPT
EGYPTPARENTERAL ORDINARY AMPOULES1.0X6.0X5.0 ML AMPOULE01/07/2016
576NDA/MAL/HDP/1863AMOUN PHARMACEUTICALS COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDORACURE GELLIDOCAINE HCL+CETYL PYRIDINUM CHLORIDE2 GM+0.1 GMAMOUN PHARMACEUTICALS CO. S.A.E-1ST INDUSTRIAL ZONE, EL-OBOUR CITY, EGYPT. EGYPTORAL TOPICAL GELS AND SOLS1.0X15.0 G TUBE01/07/2004
577NDA/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 BOTTLE01/07/2004
578NDA/MAL/HDP/1638AMOUN PHARMACEUTICAL COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDFLADAZOLESECNIDAZOLE500MGAMOUN PHARMACEUTICALS CO. S.A.E-1ST INDUSTRIAL ZONE, EL-OBOUR CITY, EGYPT. EGYPTORAL SOLID ORDINARY TABLETS1.0X4.0 TABLET BLISTER01/07/2005
579NDA/MAL/HDP/0192AMOUN PHARMACEUTICALS COMPANYBOOTS PHARMACEUTICALS LIMITEDAMOCOMB CREAMNEOMYCIN + TRIAMCINOLONE ACETONIDE + GRAMICIDIN0.25GM + 0.1G + 100000IU + 0.025G/100GAMOUN PHARMACEUTICALS CO. S.A.E-1ST INDUSTRIAL ZONE, EL-OBOUR CITY, EGYPT. EGYPTTOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE01/07/2014
580NDA/MAL/HDP/0187AMOUN PHARMACEUTICAL COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDKAPRON TABLETTRANEXAMIC ACID500 MGAMOUN PHARMACEUTICALS CO. S.A.E-1ST INDUSTRIAL ZONE, EL-OBOUR CITY, EGYPT. EGYPTORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER01/07/2014
581NDA/MAL/HDP/0186WIDE SPECTRUM ENTERPRISES (U) LIMITEDWIDE SPECTRUM ENTERPRISES (U) LIMITEDBBC SPRAYBENZOCAINE+BENZYDAMINE+CATALKONIUM CHLORIDE1.5%W/V+0.15%W/V+0.0413%W/VAMOUN PHARMACEUTICALS CO. S.A.E-1ST INDUSTRIAL ZONE, EL-OBOUR CITY, EGYPT. EGYPTORAL TOPICAL SPRAYS WITHOUT GAS1.0X25.0 ML BOTTLE01/07/2014
582NDA/MAL/HDP/0188AMOUN PHARMACEUTICALS LTDBOOTS PHARMACEUTICALS LIMITEDLEVOXINLEVOFLOXACIN500MGAMOUN PHARMACEUTICALS CO. S.A.E-1ST INDUSTRIAL ZONE, EL-OBOUR CITY, EGYPT. EGYPTORAL SOLID ORDINARY FILM-COATED TABLETS1.0X5.0 TABLET BLISTER01/07/2014
583NDA/MAL/HDP/3459AMOUN PHARMACEUTICALS COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDENEMAXHYPERTONIC SOLUTION OF SODIUM PHOSPHATES6GM AND 16GM/100MLAMOUN PHARMACEUTICALS COMPANY-1ST INDUSTRIAL ZONE EL OBOUR CITY CAIRO EGYPTEGYPTRECTAL SYSTEMIC ENEMA LIQUIDS1.0X120.0 ML BOTTLE01/07/1997
584NDA/MAL/HDP/3609AMOUN PHARMACEUTICALS COMPANYBOOTS PHARMACEUTICALS LIMITEDANTINALNIFUROXAZIDE200MGAMOUN PHARMACEUTICALS COMPANY-1ST INDUSTRIAL ZONE EL OBOUR CITY CAIRO EGYPTEGYPTORAL SOLID ORDINARY CAPSULES1.0X2.0X12.0 CAPSULE BLISTER,1.0X12.0 CAPSULE BLISTER01/07/1997
585NDA/MAL/HDP/3650AMOUN PHARMACEUTICALS COMPANYBOOTS PHARMACEUTICALS LIMITEDANTINALNIFUROXAZIDE220MG/5MLAMOUN PHARMACEUTICALS COMPANY-1ST INDUSTRIAL ZONE EL OBOUR CITY, CAIRO EGYPT EGYPTORAL LIQUID ORDINARY SYRUPS1.0X60.0 ML BOTTLE01/07/2011
586NDA/MAL/HDP/3770AMOUN PHARMACEUTICALS COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDXITHRONEAZITHROMYCIN500 MGAMOUN PHARMACEUTICALS COMPANY-1ST INDUSTRIAL ZONE EL OBOUR CITY, CAIRO EGYPT EGYPTORAL SOLID ORDINARY COATED TABLETS1.0X1.0X5.0 TABLET BLISTER01/07/2005
587NDA/MAL/HDP/3778AMOUN PHARMACEUTICALS COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDXITHRONEAZITHROMYCIN200MG/5MLAMOUN PHARMACEUTICALS COMPANY-1ST INDUSTRIAL ZONE EL OBOUR CITY, CAIRO EGYPT EGYPTORAL LIQUID ORDINARY SYRUPS1.0X15.0 ML BOTTLE01/07/2004
588NDA/MAL/HDP/4000AMOUN PHARMACEUTICAL COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDAPIDONE SYRUPCHLORPHENARIMINE MALEATE/DEXAMETHASONE2MG/5ML + 0.5MG/5MLAMOUN PHARMACEUTICALS COMPANY-1ST INDUSTRIAL ZONE,EL OBOUR CITY, CAIRO, EGYPT EGYPTORAL LIQUID ORDINARY SYRUPS1.0X125.0 ML BOTTLE01/07/2008
589NDA/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 STRIP01/07/2007
590NDA/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 BOTTLE01/07/2011
591NDA/MAL/HDP/1169ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDNEBI 5NEBIVOLOL HYDROCHLORIDE5MGARISTO PHARMACEUTCALS PVT LTD-PLOT NO.208 NEW INDUSTRIAL AREA NO.II MANDIDEEP 462046 RAISEN MADHYA PRADESHINDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER01/07/2013
592NDA/MAL/HDP/2956ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDTRANLOK 500MG TABLETSTRANEXAMIC ACID500MGARISTO 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 BLISTER,1.0X3.0X10.0 TABLET BLISTER01/07/2007
593NDA/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 STRIP01/07/2009
594NDA/MAL/HDP/0430ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDARISTO ACECLO PLUSACECLOFENAC+PARACETAMOL100MG+500MGARISTO PHARMACEUTICALS PVT LIMITED-PLOT 208, NEW INDUSTRIAL AREA NO II, MANDIDEEP-462 046 (DISTRICT) RAISEN, MADHYA PRADESH INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X15.0X10.0 TABLET BLISTER01/07/2013
595NDA/MAL/HDP/0326ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDOSTEBONCALCIUM + COLECALCIFEROL250MG + 125 IUARISTO PHARMACEUTICALS PVT LIMITED-PLOT 208, NEW INDUSTRIAL AREA NO II, MANDIDEEP-462 046 (DISTRICT) RAISEN, MADHYA PRADESH INDIA INDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X200.0 ML BOTTLE01/07/2014
596NDA/MAL/HDP/4528ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDPIOSAFE MF 15/500PIOGLITAZONE + METFORMIN15 MG + 500 MGARISTO PHARMACEUTICALS PVT LIMITED-PLOT 208, NEW INDUSTRIAL AREA NO II, MANDIDEEP-462 046 (DISTRICT) RAISEN, MADHYA PRADESH INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2008
597NDA/MAL/HDP/0593ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDPANTOP-DPANTOPRAZOLE SODIUM SESQUIHYDRATE + DOMPERIDONE CAPSULES20MG+10MGARISTO PHARMACEUTICALS PVT LTD .-MAKHNUMAJRA P.O BHUD BADDI DISTRICT SOLAN HIMACHAL PRADESHINDIAORAL SOLID ORDINARY ENTERIC-COATED CAPSULES1.0X10.0X10.0 CAPSULE STRIP,1.0X3.0X10.0 CAPSULE STRIP01/07/2014
598NDA/MAL/HDP/6772ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDPIOSAFE 30PIOGLITAZONE HCL30MGARISTO PHARMACEUTICALS PVT LTD -PLOT NO 208 NEW INDUSTRIAL GREEN NO2 MANDIDEED 462046INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2007
599NDA/MAL/HDP/1728ARISTO PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDDELISPRIN 75MGASPIRIN75MGARISTO PHARMACEUTICALS PVT LTD -PLOT NO 208 NEW INDUSTRIAL GREEN NO2 MANDIDEED 462046INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X10.0X10.0 TABLET STRIP,1.0X10.0X14.0 TABLET STRIP01/07/2007
600NDA/MAL/HDP/3580ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDFEXOFEN-120FEXOFENADINE HYDROCHLORIDE120MGARISTO PHARMACEUTICALS PVT LTD-PLOT NO 208 NEW INDUSTRIAL AREA N0 11 MANDIDEEPINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X6.0 TABLET BLISTER01/07/2008
601NDA/MAL/HDP/3588ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDFEXOFEN-180FEXOFENADINE180MGARISTO PHARMACEUTICALS PVT LTD-PLOT NO 208 NEW INDUSTRIAL AREA N0 11 MANDIDEEPINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X6.0 TABLET BLISTER01/07/2008
602NDA/MAL/HDP/4519ARISTO PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDS-AMLOSAFE 5AMLODIPINE BESILATE5MGARISTO PHARMACEUTICALS PVT LTD-PLOT NO 208 NEW INDUSTRIAL AREA N0 11 MANDIDEEPINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2007
603NDA/MAL/HDP/4522ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDS-AMLOSAFE 2.5AMLODIPINE BESILATE2.5 MGARISTO PHARMACEUTICALS PVT LTD-PLOT NO 208 NEW INDUSTRIAL AREA N0 11 MANDIDEEPINDIAORAL SOLID ORDINARY OTHER TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2007
604NDA/MAL/HDP/0584ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDTRIGLIMIPREX 1GLIMEPIRIDE+PIOGLITAZONE+METFORMIN HYDROCHLORIDE1MG+15MG+500MGARISTO PHARMACEUTICALS PVT LTD---VILLAGE MAKHNUMAJRA P.O BHUD BADDI DISTRICT SOLAN (H.P) 173205INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER01/07/2014
605NDA/MAL/HDP/0589ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDTRIGLIMIPREX 2GLIMEPIRIDE+PIOGLITAZONE+METFORMIN HYDROCHLORIDE2MG+15MG+500MGARISTO PHARMACEUTICALS PVT LTD---VILLAGE MAKHNUMAJRA P.O BHUD BADDI DISTRICT SOLAN (H.P) 173205INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER01/07/2014
606NDA/MAL/HDP/0595ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDORNOFORNIDAZOLE + OFLOXACIN500MG + 200MGARISTO PHARMACEUTICALS PVT LTD---VILLAGE MAKHNUMAJRA P.O BHUD BADDI DISTRICT SOLAN (H.P) 173205INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER01/07/2015
607NDA/MAL/HDP/0582ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDACECLO SERAACECLOFENAC+PARACETAMOL+SERRATIOPEPTIDASE100MG + 500MG + 15MGARISTO PHARMACEUTICALS PVT LTD-VILLAGE: MAKHNUMAJRA P.O. BHUD BADDI DISTRIC: SOLAN (H.P) 173205INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER01/07/2015
608NDA/MAL/HDP/2170ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDALSARTAN-AMLOSARTAN + AMLODIPINE50MG + 5MGARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO. II, MANDIDEEP-462046, DIST. - RAISEN, MADHYA PRADESH, INDIA. INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X4.0X7.0 TABLET BLISTER01/07/2011
609NDA/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 STRIP01/07/2013
610NDA/MAL/HDP/0429ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDFLEXON MRIBUPROFEN + PARACETAMOL + CHLORZOXAZONE400MG + 325MG + 250MGARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO. II, MANDIDEEP-462046, DIST. - RAISEN, MADHYA PRADESH, INDIA. INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2014
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 BLISTER01/07/2014
612NDA/MAL/HDP/1463ARISTO PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDARISTOZYME LIQUIDDIASTASE+PEPSIN50MG+10MGARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO. II, MANDIDEEP-462046, DIST. - RAISEN, MADHYA PRADESH, INDIA. INDIAORAL LIQUID ORDINARY LIQUIDS1.0X200.0 ML BOTTLE01/07/2015
613NDA/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 STRIP01/07/2007
614NDA/MAL/HDP/2077ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDAMBRODILAMBROXOL HYDROCHLORIDE30MG/5MLARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO.II,MANDIDEEEP PRADESH INDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE01/07/2007
615NDA/MAL/HDP/0460ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDAMBRODILAMBROXOL HYDROCHLORIDE7.5MG/MLARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO.II,MANDIDEEEP PRADESH INDIAORAL LIQUID ORDINARY LIQUIDS1.0X15.0 ML BOTTLE01/07/2009
616NDA/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 AMPOULE01/07/2010
617NDA/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 AMPOULE01/07/2013
618NDA/MAL/HDP/4307ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDMIKACINAMIKACIN SULPHATE500MG/2MLARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO.II,MANDIDEEEP PRADESH INDIAPARENTERAL ORDINARY VIALS1.0X5.0X8.0X2.0 ML VIAL,1.0X1.0X2.0 ML VIAL01/07/2009
619NDA/MAL/HDP/4523ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDBIGOMET SR 500METFORMIN HYDROCHLORIDE500MGARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO.II,MANDIDEEEP PRADESH INDIAORAL SOLID RETARD TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2008
620NDA/MAL/HDP/2593E DENK OHGBENLE CONSULT LIMITEDATENOLOL DENK 50ATENOLOL50MGARTESAN PHARMA GMBH & CO. KG -WENDLANDSTRABE 1,29439 LUCHOW,GERMANY GERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2005
621NDA/MAL/HDP/0600DENK PHARM GMBH&CO.KGBENLE CONSULT LIMITEDCARVEDI-DENK 6.25CARVEDILOL6.25MGARTESAN PHARMA GMBH & CO. KG -WENDLANDSTRABE 1,29439 LUCHOW,GERMANY GERMANYORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2015
622NDA/MAL/HDP/0605DENK PHARM GMBH&CO.KGBENLE CONSULT LIMITEDCARVEDI-DENK 25CARVEDILOL25MGARTESAN PHARMA GMBH & CO. KG -WENDLANDSTRABE 1,29439 LUCHOW,GERMANY GERMANYORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2015
623NDA/MAL/HDP/0609DENK PHARMA GMBH & CO KGBENLE CONSULT LIMITEDCLOPI-DENK 75CLOPIDOGREL BESYLATE75MGARTESAN PHARMA GMBH & CO. KG -WENDLANDSTRABE 1,29439 LUCHOW,GERMANY GERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2015
624NDA/MAL/HDP/8778I CARE PHARMA LIMITEDAIVEEN (U) LIMITEDAIVCEF-250CEFUROXIME AXETIL250MGASSOCIATED BIOTECH-KRISHANPURA, P. O GURUMAJRA, BADDI, DIST. SOLAN INDIAORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER26/11/2019
625NDA/MAL/HDP/8781I CARE PHARMA LIMITEDAIVEEN (U) LIMITEDAIVXIM-400CEFIXIME400MGASSOCIATED BIOTECH-KRISHANPURA, P. O GURUMAJRA, BADDI, DIST. SOLAN INDIAORAL SOLID ORDINARY TABLETS1.0X1.0X6.0 TABLET BLISTER26/11/2019
626NDA/MAL/HDP/8784I CARE PHARMA LIMITEDAIVEEN (U) LIMITEDAIVCEF-500CEFUROXIME AXETIL500MGASSOCIATED BIOTECH-KRISHANPURA, P. O GURUMAJRA, BADDI, DIST. SOLAN INDIAORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER26/11/2019
627NDA/MAL/HDP/8785I CARE PHARMA LIMITEDAIVEEN (U) LIMITEDAIVCEF SUSPENSIONCEFUROXIME AXETIL125MG/5MLASSOCIATED BIOTECH-KRISHANPURA, P. O GURUMAJRA, BADDI, DIST. SOLAN INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X60.0 ML BOTTLE26/11/2019
628NDA/MAL/HDP/8786I CARE PHARMA LIMITEDAIVEEN (U) LIMITEDAIVXIMCEFIXIME TRIHYDRATE100MGASSOCIATED BIOTECH-KRISHANPURA, P. O GURUMAJRA, BADDI, DIST. SOLAN INDIAORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER26/11/2019
629NDA/MAL/HDP/8787I CARE PHARMA LIMITEDAIVEEN (U) LIMITEDAIVXIM-200CEFIXIME200MGASSOCIATED BIOTECH-KRISHANPURA, P. O GURUMAJRA, BADDI, DIST. SOLAN INDIAORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER26/11/2019
630NDA/MAL/HDP/8788I CARE PHARMA LIMITEDAIVEEN (U) LIMITEDAIVPOD-200CEFPODOXIME PROXETIL200MGASSOCIATED BIOTECH-KRISHANPURA, P. O GURUMAJRA, BADDI, DIST. SOLAN INDIAORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER26/11/2019
631NDA/MAL/HDP/1808ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDASTACIDMAGNESIUM TRISILICATE370MGASTRA LIFE CARE (INDIA) PVT LIMITED-57/P RAJODA
382220 BAVIA
AHMEDABAD INDIA
INDIAORAL SOLID ORDINARY CHEWABLE TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER01/07/1997
632NDA/MAL/HDP/1481ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDASTROGYLMETRONIDAZOLE200MGASTRA LIFE CARE (INDIA) PVT LIMITED-57/P RAJODA
382220 BAVIA
AHMEDABAD INDIA
INDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER01/07/1997
633NDA/MAL/HDP/1614ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDASTAGRA-50SILDENAFIL50MGASTRA LIFE CARE (INDIA) PVT LIMITED-57/P RAJODA
382220 BAVIA
AHMEDABAD INDIA
INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X1.0X4.0 TABLET BLISTER01/07/2011
634NDA/MAL/HDP/2936ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDFEMIN-PNYSTATIN100,000IUASTRA LIFE CARE (INDIA) PVT LTD-57/P,RAJODA 382220, BAVLA AHMEDABAD INDIA INDIAVAGINAL TABLETS1.0X15.0 PESSARY BLISTER01/07/2007
635NDA/MAL/HDP/3493ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDASVIRACICLOVIR200MGASTRA LIFE CARE (INDIA) PVT LTD-57/P,RAJODA 382220, BAVLA AHMEDABAD INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2007
636NDA/MAL/HDP/3505ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDASFLICFOLIC ACID5MGASTRA LIFE CARE (INDIA) PVT LTD-57/P,RAJODA 382220, BAVLA AHMEDABAD INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER01/07/2007
637NDA/MAL/HDP/3660ASTRA PHARMA (U) PVT LTDASTRA PHARMA (U) LIMITEDASTAGRASILDENAFIL CITRATE100MGASTRA LIFE CARE (INDIA) PVT LTD-57/P,RAJODA 382220, BAVLA AHMEDABAD INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X4.0 TABLET BLISTER01/07/2010
638NDA/MAL/HDP/1645ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDASTAZOLEMEBENDAZOLE100MGASTRA LIFE CARE (INDIA) PVT.LTD-PLOT 57/P, RAJODA-382220, BAVLA AHMEDABAD, INDIA INDIAORAL SOLID ORDINARY CHEWABLE TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER01/07/1997
639NDA/MAL/HDP/0025ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDAMLOAS-5AMLODIPINE5MGASTRA LIFE CARE (INDIA) PVT.LTD-PLOT 57/P, SARKHEJ-BAVLA HIGHWAY, RAJODA 382 220,TALUKA BAVLA DIST AHMEDABAD, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2013
640NDA/MAL/HDP/1346ASTRA PHARMA LTDASTRA PHARMA (U) LIMITEDASIXFUROSEMIDE40MGASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER01/07/2010
641NDA/MAL/HDP/2549ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDAZY-250AZITHROMYCIN250MGASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X6.0 TABLET BLISTER01/07/2011
642NDA/MAL/HDP/0026ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDAMLOAS-10AMLODIPINE10MGASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2015
643NDA/MAL/HDP/0385ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDASFORMINMETFORMIN HYDROCHLORIDE500MGASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2015
644NDA/MAL/HDP/0332ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDROSUVAX 20ROSUVASTATIN CALCIUM20MGASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X15.0 TABLET BLISTER01/07/2015
645NDA/MAL/HDP/3161ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDASCILLINAMPICILLIN250MGASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIA INDIAORAL SOLID ORDINARY CAPSULES1.0X1000.0 CAPSULE CONTAINER,1.0X100.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER01/07/1997
646NDA/MAL/HDP/3345ASTRA PHARMACY (U) PVT LTDASTRA PHARMA (U) LIMITEDPAINOL-PPARACETAMOL + CAFFEINE650MG + 50MGASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X25.0X4.0 TABLET STRIP01/07/2010
647NDA/MAL/HDP/3401ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDASCODYLBISACODYL5MGASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIA INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2010
648NDA/MAL/HDP/3570ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDASTRIM-960TRIMETHOPRIM/SULFAMETHOXAZOLE160MG/800MGASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER01/07/2008
649NDA/MAL/HDP/3675ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDASCOPAN - SCHYOSCINE BUTYLBROMIDE10MGASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIA INDIAORAL SOLID ORDINARY OTHER COATED TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER01/07/2008
650NDA/MAL/HDP/4021ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDAZY-500AZITHROMYCIN500MGASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0 TABLET BLISTER01/07/2011
651NDA/MAL/HDP/4295ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDASTRAFLAM TABLETSPARACETAMOL + IBUPROFEN500MG + 400MGASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2016
652NDA/MAL/HDP/4571ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDASPICLOXAMPICILLIN + CLOXACILLIN250 MG + 250 MGASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIA INDIAORAL SOLID ORDINARY CAPSULES10.0X10.0 CAPSULE STRIP,1.0X1000.0 CAPSULE CONTAINER01/07/1997
653NDA/MAL/HDP/4662ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDASDOLTRAMADOL50MGASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIA INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER01/07/2011
654NDA/MAL/HDP/4873ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDFLUCASFLUCONAZOLE200MGASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIA INDIAORAL SOLID ORDINARY CAPSULES1.0X4.0 CAPSULE BLISTER01/07/2011
655NDA/MAL/HDP/4884ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDASFULVIN-500GRISEOFULVIN500MGASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2008
656NDA/MAL/HDP/1833ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDASMOXAMOXICILLIN500MGASTRA LIFE CARE (INDIA) PVT-SURVEY NO.57/P, SARKHEJ-BAVLA HIGHWAY, POST- RAJOD-382220, TALUKA-BAVLA, DIST-AHMEDABAD. INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER01/07/2011
657NDA/MAL/HDP/0093ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDLORASLORATADINE10MGASTRA LIFE CARE (INDIA) PVT-SURVEY NO.57/P, SARKHEJ-BAVLA HIGHWAY, POST- RAJOD-382220, TALUKA-BAVLA, DIST-AHMEDABAD. INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER01/07/2013
658NDA/MAL/HDP/0099ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDCARBASCARBAMAZEPINE200MGASTRA LIFE CARE (INDIA) PVT-SURVEY NO.57/P, SARKHEJ-BAVLA HIGHWAY, POST- RAJOD-382220, TALUKA-BAVLA, DIST-AHMEDABAD. INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER01/07/2014
659NDA/MAL/HDP/0982ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDASMETO-10METOCLOPRAMIDE10MGASTRA LIFE CARE (INDIA) PVT-SURVEY NO.57/P, SARKHEJ-BAVLA HIGHWAY, POST- RAJOD-382220, TALUKA-BAVLA, DIST-AHMEDABAD. INDIAORAL SOLID ORDINARY OTHER COATED TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER01/07/2014
660NDA/MAL/HDP/0096ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDLIPORATORVASTATIN20MGASTRA LIFE CARE (INDIA) PVT-SURVEY NO.57/P, SARKHEJ-BAVLA HIGHWAY, POST- RAJOD-382220, TALUKA-BAVLA, DIST-AHMEDABAD. INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X15.0 TABLET BLISTER01/07/2015
661NDA/MAL/HDP/0169ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDROSUVAX 10ROSUVASTATIN10MGASTRA LIFE CARE (INDIA) PVT-SURVEY NO.57/P, SARKHEJ-BAVLA HIGHWAY, POST- RAJOD-382220, TALUKA-BAVLA, DIST-AHMEDABAD. INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X15.0 TABLET BLISTER01/07/2015
662NDA/MAL/HDP/2934ASTRA LIFE CARE PVT LTDASTRA PHARMA (U) LIMITEDASTOLONPREDNISOLONE5MGASTRA LIFE CARE PVT LTD-57/P RAJODA-382220 BAVIA AHMEDABAD INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER01/07/2007
663NDA/MAL/HDP/3366ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDDIASGLIBENCLAMIDE5MGASTRA LIFE CARE(INDIA) PVT LTD-57/P, POJODA, 382220, BOVIA, AHMEDOBAD, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2011
664NDA/MAL/HDP/3900ASTRA PHARMA UGANDA LTDASTRA PHARMA (U) LIMITEDASTIBA-500TINIDAZOLE500MGASTRA LIFE CARE(INDIA) PVT LTD-57/P, POJODA, 382220, BOVIA, AHMEDOBAD, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X25.0X4.0 TABLET BLISTER01/07/2009
665NDA/MAL/HDP/6509ASTRA LIFECARE (INDIA) PVT. LTDASTRA PHARMA (U) LIMITEDASPYROXPIROXICAM20MGASTRA LIFE CARE(INDIA) PVT LTD-PLOT NO. 57/P, SARKHEJ – BAVLA HIGHWAY, POST. RAJODA – 382220, TALUKA: BAVLA, DIST. AHMEDABAD INDIAORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER01/07/2017
666NDA/MAL/HDP/6881ASTRA LIFECARE (INDIA) PVT. LTDASTRA PHARMA (U) LIMITEDASTRALEVOFLOXALEVOFLOXACIN500MGASTRA LIFE CARE(INDIA) PVT LTD-PLOT NO. 57/P, SARKHEJ – BAVLA HIGHWAY, POST. RAJODA – 382220, TALUKA: BAVLA, DIST. AHMEDABAD INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER31/01/2018
667NDA/MAL/HDP/8283ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDQUINASQUININE SULPHATE BP300MGASTRA LIFE CARE(INDIA) PVT LTD-PLOT NO. 57/P, SARKHEJ – BAVLA HIGHWAY, POST. RAJODA – 382220, TALUKA: BAVLA, DIST. AHMEDABAD INDIAORAL SOLID ORDINARY COATED TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER01/07/2009
668NDA/MAL/HDP/3560ASTRA PHARMA UGANDA LIMITEDASTRA PHARMA (U) LIMITEDDERMIZOLKETOCONAZOLE200MGASTRA LIFE CARE(INDIA) PVT LTD-PLOT NO. 57/P, SARKHEJ – BAVLA HIGHWAY, POST. RAJODA – 382220, TALUKA: BAVLA, DIST. AHMEDABAD INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER01/07/2009
669NDA/MAL/HDP/3923ASTRA PHARMA UGANDA LIMITEDASTRA PHARMA (U) LIMITEDAXASONEDEXAMETHASONE0.5MGASTRA LIFE CARE(INDIA) PVT LTD-PLOT NO. 57/P, SARKHEJ – BAVLA HIGHWAY, POST. RAJODA – 382220, TALUKA: BAVLA, DIST. AHMEDABAD INDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER01/07/2008
670NDA/MAL/HDP/7390ASTRA LIFECARE (INDIA) PVT. LTDASTRA PHARMA (U) LIMITEDCIDOPRAZESOMEPRAZOLE40MGASTRA LIFECARE (INDIA) PVT. LTD'-PLOT 57 / P, SARKHEJ - BAVLA HIGHWAY RAJODA AHMEDABA INDIAORAL SOLID ORDINARY TABLETS1.0X15.0 TABLET BLISTER28/11/2019
671NDA/MAL/HDP/2939ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDASTODIUMLOPERAMIDE HYDROCHLORIDE2MGASTRA LIFECARE (INDIA) PVT. LTD-PLOT 57/P, SARKHEJ-BAVLA HIGHWAY, RAJODA 382 220, AHMEDABAD, INDIA INDIAORAL SOLID ORDINARY OTHER CAPSULES1.0X10.0X10.0 CAPSULE BLISTER01/07/2007
672NDA/MAL/HDP/0028ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDHYPERLOK-50ATENOLOL50MGASTRA LIFECARE (INDIA) PVT. LTD-PLOT 57/P, SARKHEJ-BAVLA HIGHWAY, RAJODA 382 220, AHMEDABAD, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2013
673NDA/MAL/HDP/0029ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDHYPERLOK-100ATENOLOL100MGASTRA LIFECARE (INDIA) PVT. LTD-PLOT 57/P, SARKHEJ-BAVLA HIGHWAY, RAJODA 382 220, AHMEDABAD, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2013
674NDA/MAL/HDP/0336ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDAS-DP TABLETSDICYCLOMINE HCL + PARACETAMOL20MG+500MGASTRA LIFECARE (INDIA) PVT. LTD-PLOT 57/P, SARKHEJ-BAVLA HIGHWAY, RAJODA 382 220, AHMEDABAD, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET STRIP01/07/2013
675NDA/MAL/HDP/1228ASTRA LIFECARE (INDIA) PVT. LTDASTRA PHARMA (U) LIMITEDLUMETHERARTEMETHER + LUMEFANTRINE20 MG + 120 MGASTRA LIFECARE (INDIA) PVT. LTD-PLOT 57/P, SARKHEJ-BAVLA HIGHWAY, RAJODA 382 220, AHMEDABAD, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X4.0X6.0 TABLET BLISTER01/07/2010
676NDA/MAL/HDP/0360ASTRA ZENECA ABMACNAUGHTON LIMITEDNEXIUM 20MGESOMEPRAZOLE20MGASTRA ZENECA AB, SODERTALJE-GARTUNAYEGEN, SODERTALJE SWEDENORAL SOLID ORDINARY TABLETS1.0X4.0X7.0 TABLET BLISTER,1.0X7.0 TABLET BLISTER,1.0X14.0 TABLET CARTON01/07/2001
677NDA/MAL/HDP/4367ASTRA ZENECAMACNAUGHTON LIMITEDATACAND 8MGCANDESARTAN8MGASTRA ZENECA AB, SODERTALJE-GARTUNAYEGEN, SODERTALJE SWEDENORAL SOLID ORDINARY TABLETS1.0X2.0X14.0 TABLET BLISTER01/07/2010
678NDA/MAL/HDP/4411ASTRA ZENECAMACNAUGHTON LIMITEDATACAND PLUSCANDESARTAN + HYDROCHLOROTHIAZIDE16 MG + 12.5 MGASTRA ZENECA AB, SODERTALJE-GARTUNAYEGEN, SODERTALJE UNITED KINGDOMORAL SOLID ORDINARY TABLETS1.0X2.0X14.0 TABLET BLISTER01/07/2010
679NDA/MAL/HDP/5143ASTRA ZENECAMACNAUGHTON LIMITEDBETALOC ZOK - 25MGMETOPROLOL25MGASTRA ZENECA AB-GARTUNAVGEN SE 151 58 SODAERTAJJE SWEDENSWEDENORAL SOLID ORDINARY TABLETS1.0X1.0X14.0 TABLET BLISTER01/07/2011
680NDA/MAL/HDP/5147ASTRA ZENECAMACNAUGHTON LIMITEDBETALOC ZOK - 50MGMETOPROLOL50MGASTRA ZENECA AB-GARTUNAVGEN SE 151 58 SODAERTAJJE SWEDENSWEDENORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET CONTAINER01/07/2011
681NDA/MAL/HDP/1211ASTRA ZENECAMACNAUGHTON LIMITEDBRILINTATICAGRELOR90MGASTRA ZENECA AB-SE-151 85 SODERTALJE, SWEDEN (GARTUNAVAGEN & SNACKVIKEN) UNITED KINGDOMORAL SOLID ORDINARY TABLETS1.0X4.0X14.0 TABLET BLISTER01/07/2011
682NDA/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 CARTON01/07/2013
683NDA/MAL/HDP/5146ASTRA ZENECAMACNAUGHTON LIMITEDBETALOC ZOK - 100MGMETOPROLOL100MGASTRA ZENECA AB-SE-151 85 SODERTALJE, SWEDEN (GARTUNAVAGEN & SNACKVIKEN) SWEDENORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET CONTAINER01/07/2011
684NDA/MAL/HDP/5496ASTRA ZENECAMACNAUGHTON LIMITEDATACAND 16MGCANDESARTAN CILEXETIL16MGASTRA ZENECA AB-SE-151 85 SODERTALJE, SWEDEN (GARTUNAVAGEN & SNACKVIKEN) SWEDENORAL SOLID ORDINARY TABLETS1.0X2.0X14.0 TABLET BLISTER01/07/2010
685NDA/MAL/HDP/2233ASTRAZENECAMACNAUGHTON LIMITEDPULMICORT NEBULISERBUDESONIDE0.25MG/MLASTRA ZENECA SWEDEN OPERATIONS LIQUID PRODUCTION -KVARNBERGAGATANLZ SE-151-85,SWEDEN SWEDENLUNG ADMINISTRATION LIQUID FOR INHALATION1.0X4.0X5.0X2.0 ML VIAL01/07/2011
686NDA/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 VIAL01/07/2011
687NDA/MAL/HDP/1415ASTRA ZENECAMACNAUGHTON LIMITEDATACANDCANDESARTAN32MGASTRA ZENECA SWEDEN OPERATIONS-TABLET PRODUCTION SE-151 85, GARTUNAVAGEN, SODERTALJE
SWEDENORAL SOLID ORDINARY TABLETS1.0X2.0X14.0 TABLET BLISTER01/07/2011
688NDA/MAL/HDP/1392ASTRA ZENECAMACNAUGHTON LIMITEDZOLADEXGOSERELIN3.6MGASTRA ZENECA UK LIMITED-ASTRAZENECA UK LIMITED SILK ROAD BUSINESS PARK, MACCLES FIELD,CHESHIRE SK 10 2NA, UNITED KINGDOMPARENTERAL ORDINARY PRE-FILLED SYRINGES1.0X1.0 PREFILLED SYRINGE CARTON01/07/1997
689NDA/MAL/HDP/1931ASTRAZENECAMACNAUGHTON LIMITEDZOLADEX LAGOSERELIN ACETATE10.8MGASTRA ZENECA UK LIMITED-ASTRAZENECA UK LIMITED SILK ROAD BUSINESS PARK, MACCLES FIELD,CHESHIRE SK 10 2NA, UNITED KINGDOMPARENTERAL RETARD PRE-FILLED SYRINGES1.0X10.8 MG IMPLANT01/07/2010
690NDA/MAL/HDP/5363ASTRA ZENECAMACNAUGHTON LIMITEDCASODEX 50MGBICALUTAMIDE50MGASTRA ZENECA UK LIMITED-ASTRAZENECA UK LIMITED SILK ROAD BUSINESS PARK, MACCLES FIELD,CHESHIRE SK 10 2NA, BULK CORDEN PHARMA GMBH-OTT HAHN STRASSE ,68723
GERMANY
UNITED KINGDOMORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X14.0 TABLET BLISTER01/07/1997
691NDA/MAL/HDP/0946ASTRAZENECAMACNAUGHTON LIMITEDTENORETICATENOLOL + CHLORTHALIDONE100 MG + 25 MGASTRA ZENECA UK LIMITED-SILK ROAD BUSINESS PARK,MACCLESFIELD,CHESHIRE SK 10 2NA, UNITED KINGDOMORAL SOLID ORDINARY FILM-COATED TABLETS1.0X14.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER01/07/1997
692NDA/MAL/HDP/1828ASTRAZENECAMACNAUGHTON LIMITEDTENORETATENOLOL + CHLORTHALIDONE50 MG + 12.5 MGASTRA ZENECA UK LIMITED-SILK ROAD BUSINESS PARK,MACCLESFIELD,CHESHIRE SK 10 2NA, UNITED KINGDOMORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X14.0 TABLET BLISTER01/07/1997
693NDA/MAL/HDP/1395ASTRA ZENECA ABMACNAUGHTON LIMITEDNEXIUM 40MG IVESOMEPRAZOLE40MG/5MLASTRA ZENECA--KVARNBERGAGATAN12, SE-151 SODERTALIJE SWEDENPARENTERAL ORDINARY VIALS1.0X1.0X5.0 ML VIAL,1.0X10.0X5.0 ML VIAL01/07/2010
694NDA/MAL/HDP/0858ASTRAZENECAMACNAUGHTON LIMITEDPLENDILFELODIPINE5MGASTRAZENECA AB,-GARTUNA & SNACKVIKEN STOCKHOLM SWEDENORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET CONTAINER01/07/2001
695NDA/MAL/HDP/1397ASTRAZENECAMACNAUGHTON LIMITEDPLENDILFELODIPINE10MGASTRAZENECA AB,-GARTUNA & SNACKVIKEN STOCKHOLM SWEDENORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET CONTAINER01/07/2001
696NDA/MAL/HDP/1793MACNAUNGHTON LIMITEDMACNAUGHTON LIMITEDSYMBICORT TURBUHALERBUDESONIDE+FORMOTEROL80MCG+4.5MCG/DOSEASTRAZENECA AB,-GARTUNA & SNACKVIKEN STOCKHOLM SWEDENLUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER1.0X60.0 DOSE CANNISTER01/07/2001
697NDA/MAL/HDP/2615ASTRA ZENECA ABMACNAUGHTON LIMITEDSYMBICORT TURBUHALERBUDESONIDE+FORMOTEROL160MCG+4.5MCG/DOSEASTRAZENECA AB,-GARTUNA & SNACKVIKEN STOCKHOLM SWEDENLUNG ADMINISTRATION METERED-DOSE POWDER INHALER1.0X60.0 DOSE CANNISTER01/07/2001
698NDA/MAL/HDP/2350ASTRA ZENECA ABMACNAUGHTON LIMITEDPULMICORT TURBUHALERBUDESONIDE200MCGASTRAZENECA AB,-GARTUNA & SNACKVIKEN STOCKHOLM SWEDENLUNG ADMINISTRATION METERED-DOSE INHALER1.0X100.0 DOSE CANNISTER01/07/2001
699NDA/MAL/HDP/1803ASTRA ZENECA ABMACNAUGHTON LIMITEDNEXIUM 40MGESOMEPRAZOLE40MGASTRAZENECA AB.-GARTUNA & SNACKVIKEN STOCKHOLMSWEDENORAL SOLID ORDINARY FILM-COATED TABLETS1.0X7.0 TABLET BLISTER,1.0X14.0 TABLET CARTON,1.0X28.0 TABLET CARTON01/07/2001
700NDA/MAL/HDP/1452ASTRA ZENECAMACNAUGHTON LIMITEDZESTORETICLISINOPRIL/HYDROCHLOROTHIAZIDE20MG/12.5MGASTRAZENECA MACCLESFIELD-CHESHIREUNITED KINGDOMORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X14.0 TABLET BLISTER01/07/1997
701NDA/MAL/HDP/5362ASTRA ZENECAMACNAUGHTON LIMITEDCASODEX 150MGBICALUTAMIDE150MGASTRAZENECA MACCLESFIELD-CHESHIREUNITED KINGDOMORAL SOLID ORDINARY TABLETS2.0X14.0 TABLET STRIP01/07/2001
702NDA/MAL/HDP/1575ASTRAZENECAMACNAUGHTON LIMITEDZESTRILLISINOPRIL20MGASTRAZENECA PHARMACEUTICALS LP -HUANGSHAN ROAD, WUXI 214028, JIANGSU, CHINA. ASTRAZENECA MACCLESFIELD-CHESHIRE UNITED KINGDOMORAL SOLID ORDINARY TABLETS1.0X2.0X14.0 TABLET BLISTER01/07/1997
703NDA/MAL/HDP/1576ASTRAZENECAMACNAUGHTON LIMITEDZESTRILLISINOPRIL10MGASTRAZENECA PHARMACEUTICALS LP -HUANGSHAN ROAD, WUXI 214028, JIANGSU, CHINA. ASTRAZENECA MACCLESFIELD-UNITED KINGDOM UNITED KINGDOMORAL SOLID ORDINARY TABLETS1.0X1.0X14.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER01/07/1997
704NDA/MAL/HDP/4360ASTRAZENECAMACNAUGHTON LIMITEDZESTRILLISINOPRIL5MGASTRAZENECA PHARMACEUTICALS LP -HUANGSHAN ROAD, WUXI 214028, JIANGSU, CHINA. ASTRAZENECA MACCLESFIELD-UNITED KINGDOM UNITED KINGDOMORAL SOLID ORDINARY TABLETS1.0X14.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER01/07/1997
705NDA/MAL/HDP/0418ASTRA ZENECAMACNAUGHTON LIMITEDKOMBIGLYZE XR 5MG/1000SAXAGLIPTIN + METFORMIN5MG + 1000MGASTRAZENECA PHARMACEUTICALS LP.-4601 HIGHWAY 62 EAST MOUNT VERNON INDIANA 47620 USAUNITED STATESORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET BOTTLE01/07/2013
706NDA/MAL/HDP/0419ASTRAZENECAMACNAUGHTON LIMITEDKOMBIGLYZE XR 2.5MG/1000MGSAXAGLIPTIN + METFORMIN2.5MG + 1000MGASTRAZENECA PHARMACEUTICALS LP.-4601 HIGHWAY 62 EAST MOUNT VERNON INDIANA 47620 USAUNITED STATESORAL SOLID ORDINARY TABLETS1.0X60.0 TABLET BOTTLE01/07/2013
707NDA/MAL/HDP/1781ASTRAZENECAMACNAUGHTON LIMITEDARIMIDEXANASTROZOLE1MGASTRAZENECA PHARMACEUTICALS LP-NEWARK, DELAWARE UNITED STATESORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X14.0 TABLET BLISTER01/07/2000
708NDA/MAL/HDP/4943ASTRAZENECAMACNAUGHTON LIMITEDNOLVADEXTAMOXIFEN20MGASTRAZENECA UK LIMITED -ASTRAZENECA UK LIMITED SILK ROAD BUSINESS PARK, MACCLES FIELD,CHESHIRE SK 10 2NA, UNITED KINGDOMORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/1997
709NDA/MAL/HDP/1331ROYAL GROUPABACUS PHARMA (AFRICA) LIMITEDBETADERM N OINTMENTBETAMETHASONE VALERATE + NEOMYCIN0.1%W/W + 0.5%W/WATCO LABORATORIES PVT LTD-B-18,S.I.T.E KARACHI 75700, PAKISTAN PAKISTANTOPICAL EXTERNAL OINTMENTS1.0X15.0 G TUBE,1.0X5.0 G TUBE01/07/1997
710NDA/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 TUBE01/07/1997
711NDA/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 VIAL01/07/1997
712NDA/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 TUBE01/07/1997
713NDA/MAL/HDP/3867ROYAL GROUPABACUS PHARMA (AFRICA) LIMITEDBETADERM OINTMENTBETAMETHASONE 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 TUBE01/07/1997
714NDA/MAL/HDP/3406ATCO LABORATORIES LTDHARLEYS UGANDA LIMITEDMICRONEMANYSTATIN ORAL SUSPENSION,SODIUM CITRATE + SODIUM LAURYL SULPHATE + GLYCERIN26,450MG/10ML+75MG/10ML+ 90%V/VATCO LABORATORIES PVT LTD-B-18,S.I.T.E KARACHI, PAKISTAN PAKISTANRECTAL SYSTEMIC ENEMA LIQUIDS1.0X10.0 ML BOTTLE01/07/2005
715NDA/MAL/HDP/3421ROYAL GROUPABACUS PHARMA (AFRICA) LIMITEDCOMBINOL EATCO LABORATORIES PVT LTD-B-18,S.I.T.E KARACHI, PAKISTAN PAKISTANORAL LIQUID ORDINARY SYRUPS1.0X120.0 ML BOTTLE01/07/1999
716NDA/MAL/HDP/5187ATCO LABORATORIES LTDHARLEYS UGANDA LIMITEDHEALIT SKIN OINTMENTBACITRACIN+POLYMYXIN B SO4+NEOMYCIN+LIDOCAINE500UNITS+5000UNITS+3.5MG+40MG/GATCO LABORATORIES PVT LTD-B-18,S.I.T.E KARACHI, PAKISTAN PAKISTANTOPICAL EXTERNAL OINTMENTS1.0X10.0 G TUBE01/07/2007
717NDA/MAL/HDP/5636ATCO LABORATORIES LTDABACUS PHARMA (AFRICA) LIMITEDBETADERM NM CREAMMICONAZOLE+NEOMYCIN +BETAMETHASONE VALERATE2MG+0.5G + 0.1GATCO LABORATORIES PVT LTD-B-18,S.I.T.E KARACHI, PAKISTAN PAKISTANTOPICAL EXTERNAL CREAMS1.0X10.0 G TUBE01/07/2004
718NDA/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 TUBE01/07/2005
719NDA/MAL/HDP/6911ATCO LABORATORIES LTDHARLEYS UGANDA LIMITEDSCABIONCROTAMITON + SULPHUR10 G + 2 GATCO LABS LTD,-B-18, S.I.T.E, KARACHI INDIATOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE01/07/2005
720NDA/MAL/HDP/7487ATCO LABORATORIES LTDHARLEYS UGANDA LIMITEDBETASALICBETAMETHASONE DIPROPIONATE + SALICYLIC ACID0.05%W/W + 3%W/WATCO LABS LTD,-B-18, S.I.T.E, KARACHI PAKISTANTOPICAL EXTERNAL OINTMENTS1.0X15.0 G TUBE27/11/2019
721NDA/MAL/HDP/7610ATCO LABORATORIES LTDHARLEYS UGANDA LIMITEDTERBIDERM FORTETERBINAFINE HYDROCHLORIDE250 MGATCO LABS LTD,-B-18, S.I.T.E, KARACHI PAKISTANORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER27/11/2019
722NDA/MAL/HDP/5096ATCO LABORATORIES LTDHARLEYS UGANDA LIMITEDSCABIONCROTAMITON + SULPHUR10 G + 2G/100GATCO LABS LTD,-B-18, S.I.T.E, KARACHI INDIATOPICAL EXTERNAL OINTMENTS1.0X60.0 ML BOTTLE01/07/2003
723NDA/MAL/HDP/5287AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDEFAVIRENZ + LAMIVUDINE + TENOFOVIR DISOPROXIL FUMERATEEFAVIRENZ + LAMIVUDINE + TENOFOVIR DISOPROXIL FUMERATE600MG + 300MG + 300MGAUROBINDO PHARMA LIMITED (SEZ, UNIT – VII), -SURVEY NO.411, 425, 434, 435 & 458, APIIC, PLOT NO. SI GREEN INDUSTRIAL PARK, POLEPALLY VILLAGE, JEDCHERLA MANDAL, MAHABOOB NAGAR DISTRICT, HYDERABAD, ANDHRA PRADESH 500090, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET CONTAINER01/07/2015
724NDA/MAL/HDP/8159AUROBINDO PHARMA LIMITED (UNIT III)GITTOES PHARMACEUTICALS LIMITEDLOPINAVIR + RITONAVIRLOPINAVIR + RITONAVIR100MG + 25MGAUROBINDO PHARMA LIMITED (UNIT III) -AURO HOUSE, 313, BUCHUPALLY, QUTHUBULLAPAR(M), RR DISTRICT HYDERABAD-500090, ANDHERA PRADESH, INDIA. INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X60.0 TABLET BOTTLE01/07/2017
725NDA/MAL/HDP/1937AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDEFAVIRENZEFAVIRENZ600MGAUROBINDO PHARMA LIMITED (UNIT III) -AURO HOUSE, 313, BUCHUPALLY, QUTHUBULLAPAR(M), RR DISTRICT HYDERABAD-500090, ANDHERA PRADESH, INDIA. INDIAORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET CONTAINER01/07/2005
726NDA/MAL/HDP/3731AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDEFAVIRENZ 50MGEFAVIRENZ50MGAUROBINDO PHARMA LIMITED (UNIT III) -AURO HOUSE, 313, BUCHUPALLY, QUTHUBULLAPAR(M), RR DISTRICT HYDERABAD-500090, ANDHERA PRADESH, INDIA. INDIAORAL SOLID ORDINARY CAPSULES1.0X30.0 CAPSULE CONTAINER01/07/2007
727NDA/MAL/HDP/5275AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDEFAVIRENZEFAVIRENZ200MGAUROBINDO PHARMA LIMITED (UNIT III) -AURO HOUSE, 313, BUCHUPALLY, QUTHUBULLAPAR(M), RR DISTRICT HYDERABAD-500090, ANDHERA PRADESH, INDIA. INDIAORAL SOLID ORDINARY CAPSULES1.0X90.0 CAPSULE CONTAINER,1.0X30.0 CAPSULE CONTAINER01/07/2007
728NDA/MAL/HDP/2337AUROBINDOM PHARMA LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDAUROXETIL-500CEFUROXIME AXETIL500MGAUROBINDO 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 INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X10.0 TABLET BLISTER01/07/2007
729NDA/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 VIAL01/07/2009
730NDA/MAL/HDP/6626AUROBINDO PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDONEGABA 300GABAPENTIN300MGAUROBINDO PHARMA LIMITED, UNIT – III-SURVEY NO.:113 & 314,BACHUPALLY (VILLAGE)QUTHUBULLAPUR MANDAL, RANGA REDDY DISTRICT, TELANGANA STATE.INDIA.
INDIAORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER01/07/2010
731NDA/MAL/HDP/0213AUROBINDO PHARMA LTD (UNIT VI)PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDAUROPODOX 200CEFPODOXIME200MGAUROBINDO PHARMA LTD (UNIT VI) ,.,.,-SURVEY NOS. 329/39 & 329/47, CHITKUL VILLAGE, PATANCHERU MANDAL, MEDAK DISTRICT PIN CODE 502307, ANDHRA PRADESH INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER01/07/2013
732NDA/MAL/HDP/3004AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAUROPODOX 100CEFPODOXIME PROXETIL100MGAUROBINDO PHARMA LTD (UNIT VI) ,.,.,-SURVEY NOS. 329/39 & 329/47, CHITKUL VILLAGE, PATANCHERU MANDAL, MEDAK DISTRICT PIN CODE 502307, ANDHRA PRADESH INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER01/07/2007
733NDA/MAL/HDP/1112AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDZIDOVUDINE CAPSULESZIDOVUDINE100MGAUROBINDO PHARMA LTD .-UNIT III SURVEY NO.313 BACHUINDIAORAL SOLID ORDINARY CAPSULES1.0X100.0 CAPSULE CONTAINER01/07/2008
734NDA/MAL/HDP/4686AUROBINDOM PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDZIDOVUDINE ORAL SOLUTION USPZIDOVUDINE50MG/5MLAUROBINDO PHARMA LTD .-UNIT III SURVEY NO.313 BACHUINDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X240.0 ML BOTTLE01/07/2007
735NDA/MAL/HDP/8190AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDLAMIVUDINE TABLETSLAMIVUDINE150 MGAUROBINDO PHARMA LTD UNIT III-AUROBINDO PHARMA LTD UNIT III SURVEY NO. 313 BACHUPALLY VILLAGE QUTHUBULLAPUR MANDAL RANGA REDDY DISTRICT (A.P)INDIAORAL SOLID ORDINARY TABLETS1.0X60.0 TABLET BOTTLE01/07/2005
736NDA/MAL/HDP/5224AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDEMTRICITABINE+TENOFOVIR DISOPROXIL FUMERATEEMTRICITABINE/TENOFOVIR DISOPROXIL FUMERATE200MG/300MGAUROBINDO PHARMA LTD UNIT III-AUROBINDO PHARMA LTD UNIT III SURVEY NO. 313 BACHUPALLY VILLAGE QUTHUBULLAPUR MANDAL RANGA REDDY DISTRICT (A.P)INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X30.0 TABLET CONTAINER01/07/2009
737NDA/MAL/HDP/4410AUROBINDO PHARMA LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDM-KAST 4MONTELUKAST CHEWABLE TABLETS 4 MG4MGAUROBINDO 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 CHEWABLE TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2016
738NDA/MAL/HDP/4412AUROBINDO PHARMA LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDM-KAST 5MONTELUKAST SODIUM5MGAUROBINDO 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 CHEWABLE TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2016
739NDA/MAL/HDP/8661AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDDOLUTEGRAVIR TABLETS 50MGDOLUTEGRAVIR SODIUM50MGAUROBINDO 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 FILM-COATED TABLETS1.0X1.0X30.0 TABLET BOTTLE28/03/2018
740NDA/MAL/HDP/8188AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDLAMIVUDINE + ZIDOVUDINE + NEVIRAPINELAMIVUDINE + ZIDOVUDINE + NEVIRAPINE150MG + 300MG + 200MGAUROBINDO PHARMA LTD UNIT VII-SEZ SURVEY NO. 411/P,425/P, 434/P, 435/P AND 458/P PLOT NO S1 ( PART) SPECIAL ECONOMIC ZONE GREEN INDUSTRIAL PARK POLEPALLY VILLAGRE ANDHRA PRADESH 509302 INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X60.0 TABLET BOTTLE01/07/2011
741NDA/MAL/HDP/5281AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDEFAVIRENZ+EMTRICITABINE+TENOFOVIR DISOPROXILEFAVIRENZ + EMTRICITABINE + TENOFOVIR DISOPROXIL FUMARATE600MG +200MG + 300MGAUROBINDO PHARMA LTD UNIT VII-SEZ SURVEY NO. 411/P,425/P, 434/P, 435/P AND 458/P PLOT NO S1 ( PART) SPECIAL ECONOMIC ZONE GREEN INDUSTRIAL PARK POLEPALLY VILLAGRE ANDHRA PRADESH 509302 INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X30.0 TABLET CONTAINER01/07/2015
742NDA/MAL/HDP/7315AUROBINDO PHARMA LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDAROXICAM 7.5MELOXICAM7.5MGAUROBINDO PHARMA LTD, UNIT III -SURVEY NO. 313, 314 BACHUPALLY (VILLAGE) QUTHUBULLAPUR (MANDAL) RR DISTRICT HYDERABAD ANDHRA PRADESH 500090 INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER27/11/2019
743NDA/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 BOTTLE01/07/2007
744NDA/MAL/HDP/2346AUROBINDOM PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDABACAVIR SULFATE ORAL SOLUTIONABACAVIR SULPHATE20MG/MLAUROBINDO PHARMA LTD, UNIT III -SURVEY NO. 313, 314 BACHUPALLY (VILLAGE) QUTHUBULLAPUR (MANDAL) RR DISTRICT HYDERABAD ANDHRA PRADESH 500090 INDIAORAL LIQUID ORDINARY LIQUIDS1.0X240.0 ML BOTTLE01/07/2008
745NDA/MAL/HDP/3322AUROBINDOM PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDNEVIRAPINENEVIRAPINE50MGAUROBINDO PHARMA LTD, UNIT III -SURVEY NO. 313, 314 BACHUPALLY (VILLAGE) QUTHUBULLAPUR (MANDAL) RR DISTRICT HYDERABAD ANDHRA PRADESH 500090 INDIAORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET CONTAINER01/07/2012
746NDA/MAL/HDP/3397AUROBINDOM PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDTENOFOVIR DISOPROXIL FUMARATETENOFOVIR DISOPROXIL FUMARATE300MGAUROBINDO PHARMA LTD, UNIT III -SURVEY NO. 313, 314 BACHUPALLY (VILLAGE) QUTHUBULLAPUR (MANDAL) RR DISTRICT HYDERABAD ANDHRA PRADESH 500090 INDIAORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET BOTTLE01/07/2011
747NDA/MAL/HDP/2342AUROBINDO PHARMA LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDKOACT-625AMOXICILLIN + CLAVULANATE POTASSIUM500 MG + 125 MGAUROBINDO PHARMA LTD, UNIT XII,.-SURVEY NO 314, BACHUPALLY VILLAGE, QUTHUBULLAPAR, R.R DISTRICT .A. PRADESH INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X5.0 TABLET BLISTER01/07/2007
748NDA/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 BLISTER01/07/2007
749NDA/MAL/HDP/4175AUROBINDO PHARMA LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDKOACT 156.25AMOXYCILLIN TRIHYDRATE+POTASSIUM CLAVUNALATE156.25MG/5MLAUROBINDO PHARMA LTD, UNIT XII,.-SURVEY NO 314, BACHUPALLY VILLAGE, QUTHUBULLAPAR, R.R DISTRICT .A. PRADESH INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE01/07/2007
750NDA/MAL/HDP/8191AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDDIDANOSINE DELAYED-RELEASEDIDANOSINE DELAYED-RELEASE400MGAUROBINDO PHARMA LTD-UNIT III-SURVEY NO.313,BACHUPALLY VILLAGE,QUTHUBULLAPUR MANDAL R.R DISTRICT(A.P),INDIA INDIAORAL SOLID RETARD CAPSULES1.0X30.0 CAPSULE BOTTLE01/07/2009
751NDA/MAL/HDP/2327AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDABACAVIR SULPHATEABACAVIR SULPHATE300MGAUROBINDO PHARMA LTD-UNIT III-SURVEY NO.313,BACHUPALLY VILLAGE,QUTHUBULLAPUR MANDAL R.R DISTRICT(A.P),INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X60.0 TABLET CONTAINER01/07/2007
752NDA/MAL/HDP/3127AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDDIDANOSINE DELAYED - RELEASDIDANOSINE DELAYED RELEASE250MGAUROBINDO PHARMA LTD-UNIT III-SURVEY NO.313,BACHUPALLY VILLAGE,QUTHUBULLAPUR MANDAL R.R DISTRICT(A.P),INDIA INDIAORAL SOLID RETARD CAPSULES1.0X30.0 CAPSULE CONTAINER01/07/2009
753NDA/MAL/HDP/2132AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDLOPINAVIR/ RITONAVIRLOPINAVIR/ RITONAVIR200MG/ 50MGAUROBINDO PHARMA LTD-UNIT III-SURVEY NO.313,BACHUPALLY VILLAGE,QUTHUBULLAPUR MANDAL R.R DISTRICT(A.P),INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X120.0 TABLET CONTAINER01/07/2010
754NDA/MAL/HDP/4068AUROBINDO PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDLAMIVUDINE/ZIDOVUDINE/EFAVIRENZLAMIVUDINE+ZIDOVUDINE + EFAVIRENZ150MG + 300MG + 600MGAUROBINDO PHARMA LTD-UNIT III-SURVEY NO.313,BACHUPALLY VILLAGE,QUTHUBULLAPUR MANDAL R.R DISTRICT(A.P),INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X6.0X15.0 TABLET BLISTER01/07/2007
755NDA/MAL/HDP/4570AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDNEVIRAPINENEVIRAPINE200MGAUROBINDO PHARMA LTD-UNIT III-SURVEY NO.313,BACHUPALLY VILLAGE,QUTHUBULLAPUR MANDAL R.R DISTRICT(A.P),INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X60.0 TABLET CONTAINER01/07/2005
756NDA/MAL/HDP/4834AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDFINAGENFINASTERIDE5MGAUROBINDO PHARMA LTD-UNIT III-SURVEY NO.313,BACHUPALLY VILLAGE,QUTHUBULLAPUR MANDAL R.R DISTRICT(A.P),INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X10.0 TABLET BLISTER01/07/2004
757NDA/MAL/HDP/5431AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDZIDOVUDINEZIDOVUDINE300MGAUROBINDO PHARMA LTD-UNIT III-SURVEY NO.313,BACHUPALLY VILLAGE,QUTHUBULLAPUR MANDAL R.R DISTRICT(A.P),INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X60.0 TABLET BOTTLE01/07/2005
758NDA/MAL/HDP/1493AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDKOACT 1000AMOXICILLIN/CLAVULANATE POTASSIUM875MG/125MGAUROBINDO PHARMA LTD-UNIT VII (SEZ), PLOT NO.S1, GREEN INDUSTRIAL PARK,
POLEPALLY (V) JEDCHERIA (M), MAHABOOB NAGAR
INDIAORAL SOLID RETARD TABLETS1.0X3.0X5.0 TABLET BLISTER01/07/2007
759NDA/MAL/HDP/7498AUROBINDOM PHARMA LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDCELDOL 100CELECOXIB200 MGAUROBINDO PHARMA LTD-UNIT VII ,/-SY. NO'S 411, 425, 434, 435 & 458, PLOT NO. S1 (PART), SPECIAL ECONOMIC ZONE (PHARMA), APIIC, GREEN INDUSTRIAL PARK, POLEPALLY VILLAGE JEDEHERLA MANDAL, MAHABOOB NAGAR DISTRICT-509302, ANDHRA PRADESH INDIAORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER27/11/2019
760NDA/MAL/HDP/7499AUROBINDOM PHARMA LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDCELDOL 200CELECOXIB200 MGAUROBINDO PHARMA LTD-UNIT VII ,/-SY. NO'S 411, 425, 434, 435 & 458, PLOT NO. S1 (PART), SPECIAL ECONOMIC ZONE (PHARMA), APIIC, GREEN INDUSTRIAL PARK, POLEPALLY VILLAGE JEDEHERLA MANDAL, MAHABOOB NAGAR DISTRICT-509302, ANDHRA PRADESH INDIAORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER27/11/2019
761NDA/MAL/HDP/7503AUROBINDOM PHARMA LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDDUTABIT 0.5DUTASTERIDE0.5 MGAUROBINDO PHARMA LTD-UNIT VII ,/-SY. NO'S 411, 425, 434, 435 & 458, PLOT NO. S1 (PART), SPECIAL ECONOMIC ZONE (PHARMA), APIIC, GREEN INDUSTRIAL PARK, POLEPALLY VILLAGE JEDEHERLA MANDAL, MAHABOOB NAGAR DISTRICT-509302, ANDHRA PRADESH INDIAORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER27/11/2019
762NDA/MAL/HDP/5376AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDLAMIVUDINE & ZIDOVUDINELAMIVUDINE + ZIDOVUDINE150MG+300MGAUROBINDOPHARMA LIMITED,-SURVEY NO. 313 & 314, BACHUPALLY VILLAGE,
QUTHUBULLAPUR MANDAL, HYDERABAD,
RANGA REDDY (DT),
ANDHRA PRADESH - 500090
INDIA.
INDIAORAL SOLID ORDINARY TABLETS1.0X60.0 TABLET CONTAINER01/07/2005
763NDA/MAL/HDP/4468AUROBINDO PHARMA LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDTOPRAZ 40PANTOPRAZOLE SODIUM SESQUIHYDRATE40MGAUROBINDOPHARMA LIMITED,-UNIT VII, SEZ APIIC, PLOT NO.SI SURVEY NO’S 425, 434,435 & 458 GREEN INDUSTRIAL PARK, POLEPALLY VILLAGEJEDCHERTA MANDAL, MAHABOOBNAGAR DISTTRICT, ANDRA PRADESH, INDIA. AUROBINDO UNIT XV-PLOT NO. 17 A, E. BONANGI (VILLAGE), JAWAHARLAL NEHRU PHARMA CITY, PARAWADA MANDAL, VISAKHAPATNAM DIST, ANDHRA PRADESH -531021 INDIA INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2016
764NDA/MAL/HDP/7373OCHOA LABORATORIESSUPER MEDIC LTDFUSIGO CREAMFUSIDIC ACID2.0 % W/WAUROCHEM LABORATORIES (I) PVT LTD--8 PALGHAR TALUKA INDUSTRIAL CO-OP ESTATE LTD PALGHAR 401 404 DIST THANEINDIATOPICAL EXTERNAL CREAMS1.0X10.0 G TUBE01/07/2017
765NDA/MAL/HDP/7374OCHOA LABORATORIESSUPER MEDIC LTDFUSIGO-HC CREAMFUSIDIC ACID +HYDROCORTISONE ACETATE2.0 % W/W+1.0 % W/WAUROCHEM LABORATORIES (I) PVT LTD--8 PALGHAR TALUKA INDUSTRIAL CO-OP ESTATE LTD PALGHAR 401 404 DIST THANEINDIATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE29/11/2017
766NDA/MAL/HDP/7450OCHOA LABORATORIESSUPER MEDIC LTDDOLOACT GELKETOPROFEN + CAPSICUM OLEORESIN2.50%W/W + 0.25%W/WAUROCHEM LABORATORIES (I) PVT LTD--8 PALGHAR TALUKA INDUSTRIAL CO-OP ESTATE LTD PALGHAR 401 404 DIST THANEINDIATOPICAL EXTERNAL GELS AND SOLS1.0X30.0 G TUBE29/11/2017
767NDA/MAL/HDP/7482OCHOA LABORATORIESSUPER MEDIC LTDFUSIGO-B CREAMFUSIDIC ACID BP AND BETAMETHASONE VALERATE BP2.0%W/W+0.1%W/WAUROCHEM LABORATORIES (I) PVT LTD--8 PALGHAR TALUKA INDUSTRIAL CO-OP ESTATE LTD PALGHAR 401 404 DIST THANEINDIATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE29/11/2017
768NDA/MAL/HDP/7589OCHOA LABORATORIESSUPER MEDIC LTDLACX SYRUPLACTULOSE10G/15MLAUROCHEM LABORATORIES (I) PVT LTD--8 PALGHAR TALUKA INDUSTRIAL CO-OP ESTATE LTD PALGHAR 401 404 DIST THANEINDIAORAL LIQUID ORDINARY SYRUPS1.0X200.0 ML BOTTLE,1.0X100.0 ML BOTTLE29/11/2017
769NDA/MAL/HDP/8243OCHOA LABORATORIESSUPER MEDIC LTDTRANEXAMIC ACID + MEFENAMIC ACIDTRANEXAMIC ACID + MEFENAMIC ACID500MG + 250MGAUROCHEM LABORATORIES (I) PVT LTD--8 PALGHAR TALUKA INDUSTRIAL CO-OP ESTATE LTD PALGHAR 401 404 DIST THANEINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2017
770NDA/MAL/HDP/7452OCHOA LABORATORIESSUPER MEDIC LTDXTRADERM CREAMBETAMETHASONE DIPROPIONATE + GENTAMICIN SULFATE + CLOTRIMAZOLE0.64 MG/1 G + 0.1 MG/1 G + 10 MG/1 GAUROCHEM LABORATORIES LTD -PLOT 08 PALGHAR 401404 MAHARASHTRA, INDIA INDIATOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE,1.0X15.0 G TUBE,1.0X10.0 G TUBE29/11/2017
771NDA/MAL/HDP/7586OCHOA LABORATORIESSUPER MEDIC LTDCLEAR-T GELCLINDAMYCIN PHOSPHATE + TRETINOIN1.0%W/W + 0.025%W/WAUROCHEM LABORATORIES LTD -PLOT 08 PALGHAR 401404 MAHARASHTRA, INDIA INDIATOPICAL EXTERNAL GELS AND SOLS1.0X20.0 G TUBE29/11/2017
772NDA/MAL/HDP/6324AUROCHEM LABORATORIES(I) PVT LTDSUPER MEDIC LTDFUSIGOFUSIDIC ACID2.0%W/WAUROCHEM LABS (I) PVT LTD-PLOT 08, PTICE LTD PALGHAR 401404 INDIATOPICAL EXTERNAL CREAMS1.0X1.0X10.0 G TUBE28/03/2019
773NDA/MAL/HDP/7448OCHOA LABORATORIESSUPER MEDIC LTDSORID OINTMENTCALCIPOTRIOL MONOHYDRATE + BETAMETHASONE DIPROPIONATE50MCG +0.5MGAUROCHEM PHAMACEAUTICALS (1) LTD-58 PALGHAR TALUKA INDUSTRIAL CO-OEPERATIVE ESTATE LTD BOISAR RD PALGHAR DIST THANE 401404 INDIAINDIATOPICAL EXTERNAL OINTMENTS1.0X30.0 G TUBE29/11/2017
774NDA/MAL/HDP/7588OCHOA LABORATORIESSUPER MEDIC LTDEXEVATE-MF OINTMENTBETAMETHASONE DIPROPIONATE + SALICYLIC ACID + UREA + LACTIC ACID + SODIUM LACTATE SOLUTION0.05 % W/W + 3.0 % W/W + 10.0 % W/W + 3.0 % W/W + 2.0 % W/WAUROCHEM PHAMACEAUTICALS (1) LTD-58 PALGHAR TALUKA INDUSTRIAL CO-OEPERATIVE ESTATE LTD BOISAR RD PALGHAR DIST THANE 401404 INDIAINDIATOPICAL EXTERNAL OINTMENTS1.0X20.0 G TUBE29/11/2017
775NDA/MAL/HDP/7425AUROCHEM LABORATORIES(I) PVT LTDAIVEEN (U) LIMITEDDOLOACT PLUSACECLOFENAC + PARACETAMOL100MG + 500MGAUROCHEM PHARMACEUTICALS (I)-PLOT NO. 58, PTICE LTD PALGHAR 401404, MAHARASHTRA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER28/11/2019
776NDA/MAL/HDP/7365AUROCHEM PHARMACEUTICALS (INDIA) PVT LTDSUPER MEDIC LTDDOLOACT MRPARACETAMOL+ DICLOFENAC POTASSIUM+CHLORZOXAZONE500 MG+50 MG+250 MGAUROCHEM PHARMACEUTICALS INDIA PRIVATE LIMITED-58, PALGHAR TALUKA INDUSTRIAL CO - OPERATIVE ESTATE LIMITED PALGHAR, DISTRICT - PALGHAR, 401 404 INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2017
777NDA/MAL/HDP/7191AUROLABSWASTIK PHARMACEUTICAL LTDAUROSOLHYPROMELLOSE0.7%W/VAUROLAB .-NO. 1, SIVAGANGAI MAIN ROAD, VEERAPANJANI, MADURAI 1 - 625 020 INDIAOPHTHALMIC LIQUIDS1.0X1.0X10.0 ML VIAL06/02/2019
778NDA/MAL/HDP/9130AUROLABSWASTIK PHARMACEUTICAL LTDMFLOX-DMMOXIFLOXACIN + DEXAMETHASONE SODIUM PHOSPHATE0.5%W/V + 0.1%W/VAUROLAB LIMITED-NO 1 SIVAGANGAI MAIN ROAD, VEERAPANJAN MADURAI – 625 020 TAMIL NADU INDIA INDIAOPHTHALMIC DROPS1.0X5.0 ML BOTTLE26/11/2019
779NDA/MAL/HDP/0594AUROLABSWASTIK PHARMACEUTICAL LTDAUROVISC-2ML PFSHYPROMELLOSE OPHTHALMIC SOLUTION USP2%W/VAUROLAB.-SIVAGANGAI MAIN ROAD, VEERAPANJAN, MADURAI 625 020 TAMIL INDIA INDIAOPHTHALMIC PRE-FILLED SYRINGES1.0X2.0 ML PRE- FILLED SYRINGE01/07/2013
780NDA/MAL/HDP/6223AUROLABSWASTIK PHARMACEUTICAL LTDAUROPROST- RTLATANOPROST0.005%W/VAUROLAB.-SIVAGANGAI MAIN ROAD, VEERAPANJAN, MADURAI 625 020 TAMIL INDIA INDIAOPHTHALMIC DROPS1.0X2.5 ML BOTTLE01/07/2016
781NDA/MAL/HDP/0592AUROLABSWASTIK PHARMACEUTICAL LTDAUROCHROMECROMOLYN SODIUM2%W/VAUROLAB-NO 1 SIVAGANGAI MAIN ROAD, VEERAPANJAN MADURAI – 625 020 TAMIL NADU, INDIA INDIAOPHTHALMIC LIQUIDS1.0X10.0 ML CONTAINER01/07/2013
782NDA/MAL/HDP/0588AUROLABSWASTIK PHARMACEUTICAL LTDAUROFORTPREDNISOLONE ACETATE1%W/VAUROLAB-NO 1 SIVAGANGAI MAIN ROAD, VEERAPANJAN MADURAI – 625 020 TAMIL NADU, INDIA INDIAOPHTHALMIC SUSPENSIONS1.0X5.0 ML BOTTLE01/07/2013
783NDA/MAL/HDP/1341AUROLABSWASTIK PHARMACEUTICAL LTDG-FLOXGATIFLOXACIN SESQUIHYDRATE0.3%W/VAUROLAB-NO 1 SIVAGANGAI MAIN ROAD, VEERAPANJAN MADURAI – 625 020 TAMIL NADU, INDIA INDIAOPHTHALMIC LIQUIDS1.0X5.0 ML VIAL01/07/2016
784NDA/MAL/HDP/4390AUROLABSWASTIK PHARMACEUTICAL LTDAUROCOLCHLORAMPHENICOL0.5%W/VAUROLAB-NO 1 SIVAGANGAI MAIN ROAD, VEERAPANJAN MADURAI – 625 020 TAMIL NADU, INDIA INDIAOPHTHALMIC DROPS1.0X10.0 ML BOTTLE01/07/2016
785NDA/MAL/HDP/4279AUROLABSWASTIK PHARMACEUTICAL LTDAUROTIMTIMOLOL MALEATE0.5% W/VAUROLAB-NO. 1, SIVAGANGAI MAIN ROAD, VEERAPANJAN, MADURAI INDIAOPHTHALMIC DROPS1.0X5.0 ML BOTTLE01/07/2016
786NDA/MAL/HDP/0753AUROBINDO PHARMA LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDMEROGRAM 500MEROPENEM500MGAURONEXT PHARMA PRIVATE LIMITED,-A-1128, RIICO INDUSTRIAL AREA, PHASE-III,BHIWADI-301019, DISTRICT- ALWAR (RAJASTHAN), INDIA. INDIAPARENTERAL ORDINARY DRY VIALS1.0X500.0 MG VIAL01/07/2014
787NDA/MAL/HDP/0749AUROBINDO PHARMA LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDMEROGRAM 1000MEROPENEM1000MGAURONEXT PHARMA PVT LTD.-A- 1128 RIICO INDUSTRIAL AREA, PHASE III, DISTALWAR, BHIWADI INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0 G VIAL01/07/2014
788NDA/MAL/HDP/2118AVENTIS PHARMA (PTY) LTD SOUTH AFRICASURGIPHARM (U) LIMITEDRIFAFOURE E-275RIFAMPICIN+ISONIAZID+PYRAZINAMIDE+ETHAMBUTOL150MG+75MG+400MG+275MGAVENTIS PHARMA-AVENTIS PHARMA, 315 WALTLOO ROAD, SILVERTON 0127 PRETORIA SOUTH AFRICAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X4.0X20.0 TABLET BLISTER01/07/2005
789NDA/MAL/HDP/1669SANOFI AVENTISSURGIPHARM (U) LIMITEDAMARYL 2GLIMEPIRIDE2MGAVENTIS PHARMA-AVENTIS PHARMA, 315 WALTLOO ROAD, SILVERTON 0127 PRETORIA SOUTH AFRICAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2005
790NDA/MAL/HDP/1670SANOFI AVENTISSURGIPHARM (U) LIMITEDAMARYL 4GLIMIPIRIDE4MGAVENTIS PHARMA-AVENTIS PHARMA, 315 WALTLOO ROAD, SILVERTON 0127 PRETORIA SOUTH AFRICAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2005
791NDA/MAL/HDP/4121AVENTIS PHARMA (PTY) LTD SOUTH AFRICASURGIPHARM (U) LIMITEDRIFINAH 300RIFAMPICIN + ISONIAZID300MG + 150MGAVENTIS PHARMA-AVENTIS PHARMA, 315 WALTLOO ROAD, SILVERTON 0127 PRETORIA SOUTH AFRICAORAL SOLID ORDINARY TABLETS1.0X20.0 TABLET BLISTER01/07/2005
792NDA/MAL/HDP/6512AXA PARENTERALS LTDVITACARE LIMITEDAXACIPCIPROFLOXACIN200MG/100MLAXA PARENTERAL LIMITED-PLOT NO.936,937&939,
VILL. KISHANPUR, JAMALPUR,ROORKEE 247667, DISTT. HARIDWAR
(UTTARAKHAND) INDIA.
INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X100.0 ML BOTTLE31/01/2018
793NDA/MAL/HDP/7444AXA PARENTERALS LTDVITACARE LIMITEDFRESH EYESCARMELLOSE SODIUM0.5%W/VAXA PARENTERAL LIMITED-PLOT NO.936,937&939,
VILL. KISHANPUR, JAMALPUR,ROORKEE 247667, DISTT. HARIDWAR
(UTTARAKHAND) INDIA.
INDIAOPHTHALMIC DROPS1.0X1.0X10.0 ML VIAL20/12/2018
794NDA/MAL/HDP/7906AXA PARENTERALS LTDVITACARE LIMITEDIVMOLPARACETAMOL10MG/MLAXA PARENTERAL LIMITED-PLOT NO.936,937&939,
VILL. KISHANPUR, JAMALPUR,ROORKEE 247667, DISTT. HARIDWAR
(UTTARAKHAND) INDIA.
INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X100.0 ML BOTTLE01/07/2016
795NDA/MAL/HDP/2114AXA PARENTERALS LTDVITACARE LIMITEDAXA-LEVOLEVOFLOXACIN HEMIHYDRATE500MG/100MLAXA PARENTERAL LIMITED-PLOT NO.936,937&939,
VILL. KISHANPUR, JAMALPUR,ROORKEE 247667, DISTT. HARIDWAR
(UTTARAKHAND) INDIA.
INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X100.0 ML VIAL01/07/2015
796NDA/MAL/HDP/4909AXA PARENTERALS LTDVITACARE LIMITEDAXAGYLMETRONIDAZOLE0.5%W/VAXA PARENTERAL LIMITED-PLOT NO.936,937&939,
VILL. KISHANPUR, JAMALPUR,ROORKEE 247667, DISTT. HARIDWAR
(UTTARAKHAND) INDIA.
INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X100.0 ML BOTTLE01/07/2015
797NDA/MAL/HDP/1372AXA PARENTERALS LTDVITACARE LIMITEDRLCOMPOUND SODIUM LACTATE (NACL + KCL + CACL )0.115 G + 0.6G + 0.027AXA PARENTERALS LTD-KISHNPUR, JAMALPUR ROORKEE- 247677 INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X500.0 ML BOTTLE01/07/2014
798NDA/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 BOTTLE01/07/2014
799NDA/MAL/HDP/6576AXA PARENTERALS LTDVITACARE LIMITEDAXA-ZOLE FFLUCONAZOLE200 MGAXA PARENTERALS LTD-PLOT NO. 936, 937 & 939, VILLAGE KISHANPUR, JAMALPUR ROORKEE-247667, DIST. HARIDWAR, UTTARAKHAND INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X100.0 ML BOTTLE28/08/2019
800NDA/MAL/HDP/7303AXA PARENTERALS LTDVITACARE LIMITEDAXATOL-20MANNITOL20%W/VAXA PARENTERALS LTD-PLOT NO. 936, 937 & 939, VILLAGE KISHANPUR, JAMALPUR ROORKEE-247667, DIST. HARIDWAR, UTTARAKHAND INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X100.0 ML BOTTLE06/02/2019
801NDA/MAL/HDP/7394AXA PARENTERALS LTDVITACARE LIMITEDAXADEX (D50%)GLUCOSE ANHYDROUS50%W/VAXA PARENTERALS LTD-PLOT NO. 936, 937 & 939, VILLAGE KISHANPUR, JAMALPUR ROORKEE-247667, DIST. HARIDWAR, UTTARAKHAND INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X100.0 ML BOTTLE28/11/2019
802NDA/MAL/HDP/0745CADILA PHARMACEUTICALS LIMITEDESCORTS PHARMACEUTICALS LIMITEDTELI 80TELMISARTAN80MGB. BRAUN MELSUNGEN - MISTELWEG-1389, TRABAD ROAD, DHOLKA 387 810, DISTRICT AHMEDABAD, GUJARAT, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2013
803NDA/MAL/HDP/6303NAPP PHARMACEUTICALS LIMITEDSURGIPHARM (U) LIMITEDOXYNORM 5MGOXYCODONE HYDROCHLORIDE5MGBARD PHARMACEUTICALS LIMITED-UNIT 191, CAMBRIDGE SCIENCE PARK, MILTON ROAD, CAMBRIDGE, CB4 0GW, U.K UNITED KINGDOMORAL SOLID ORDINARY OTHER CAPSULES1.0X4.0X14.0 CAPSULE BLISTER20/12/2018
804NDA/MAL/HDP/6311NAPP PHARMACEUTICALS LIMITEDSURGIPHARM (U) LIMITEDOXYNORM 10MGOXYCODONE HYDROCHLORIDE10MGBARD PHARMACEUTICALS LIMITED-UNIT 191, CAMBRIDGE SCIENCE PARK, MILTON ROAD, CAMBRIDGE, CB4 0GW, U.K UNITED KINGDOMORAL SOLID ORDINARY OTHER CAPSULES1.0X4.0X14.0 CAPSULE BLISTER20/12/2018
805NDA/MAL/HDP/6321NAPP PHARMACEUTICALS LIMITEDSURGIPHARM (U) LIMITEDOXYNORM 20MGOXYCODONE HYDROCHLORIDE20MGBARD PHARMACEUTICALS LIMITED-UNIT 191, CAMBRIDGE SCIENCE PARK, MILTON ROAD, CAMBRIDGE, CB4 0GW, U.K UNITED KINGDOMORAL SOLID ORDINARY OTHER CAPSULES1.0X4.0X14.0 CAPSULE BLISTER20/12/2018
806NDA/MAL/HDP/5176BAYER AGSURGIPHARM (U) LIMITEDCANESTENCLOTRIMAZOLE100MGBAYER AG -D-51368 LEVERKUSEN GERMANYGERMANYVAGINAL TABLETS1.0X6.0 TABLET STRIP01/07/1997
807NDA/MAL/HDP/5174BAYER AGSURGIPHARM (U) LIMITEDCANESTEN CREAMCLOTRIMAZOLE1%W/VBAYER AG-D-51368 LEVERKUSEN GERMANYGERMANYTOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE01/07/1997
808NDA/MAL/HDP/0175BAYER SCHERING PHARMASURGIPHARM (U) LIMITEDXARELTO 10MGRIVAROXABAN10MGBAYER HEALTHCARE AG,-D-51368, LEVERKUSEN GERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X10.0 TABLET BLISTER01/07/2013
809NDA/MAL/HDP/0411BAYER PHARMA AGSURGIPHARM (U) LIMITEDJADELLE SINELEVONORGESTREL150MGBAYER OY-PANSIONATE 47 20210 TURKU FINLANDFINLANDPARENTERAL RETARD IMPLANTS1.0X10.0X1.0X2.0X75.0 MG IMPLANT01/07/2003
810NDA/MAL/HDP/2070BAYER PHARMA AGSURGIPHARM (U) LIMITEDMIRENALEVONORGESTREL52MGBAYER OY-PANSIONATE 47 20210 TURKU FINLANDFINLANDPARENTERAL RETARD IMPLANTS1.0X1.0 IMPLANT CARTON01/07/2009
811NDA/MAL/HDP/1433BAYER PHARMA AGSURGIPHARM (U) LIMITEDNORISTERATNORETHISTERONE ENANTATE200MGBAYER PHARMA A.G-MULLERSTRASSE 178, 13353 BERLIN, GERMANY GERMANYPARENTERAL ORDINARY VIALS1.0 ML PRE- FILLED SYRINGE,1.0X100.0X1.0 ML VIAL01/07/1997
812NDA/MAL/HDP/2149BAYER PHARMA AGSURGIPHARM (U) LIMITEDPRIMOLUT DEPOTHYDROXYPROGESTERONE HEXANOATE250MGBAYER PHARMA A.G-MULLERSTRASSE 178, 13353 BERLIN, GERMANY GERMANYPARENTERAL ORDINARY AMPOULES1.0X1.0 ML AMPOULE01/07/1997
813NDA/MAL/HDP/2063BAYER PHARMA AGSURGIPHARM (U) LIMITEDMICROGYNON FELEVONORGESTREL / ETHINYLESTRADIOL.0.15MG / 0.03MGBAYER PHARMA A.G-MULLERSTRASSE 178, 13353 BERLIN, GERMANY GERMANYORAL SOLID ORDINARY TABLETS1.0X1.0X28.0 TABLET BLISTER01/07/1997
814NDA/MAL/HDP/2306BAYER PHARMA AGSURGIPHARM (U) LIMITEDMICROLUTLEVONORGESTREL0.03MGBAYER PHARMA A.G-MULLERSTRASSE 178, 13353 BERLIN, GERMANY GERMANYORAL SOLID ORDINARY TABLETS1.0X3.0X35.0 TABLET BLISTER01/07/2010
815NDA/MAL/HDP/1294BAYER SCHERING PHARMASURGIPHARM (U) LIMITEDULTRAVIST 370IOPROMIDE370MG/MLBAYER PHARMA A.G-MULLERSTRASSE 178, 13353 BERLIN, GERMANY GERMANYPARENTERAL ORDINARY VIALS1.0X100.0 ML VIAL,1.0X50.0 ML VIAL01/07/2012
816NDA/MAL/HDP/1291BAYER SCHERING PHARMASURGIPHARM (U) LIMITEDULTRAVIST-300IOPROMIDE300MG/MLBAYER PHARMA A.G-MULLERSTRASSE 178, 13353 BERLIN, GERMANY GERMANYPARENTERAL ORDINARY VIALS1.0X50.0 ML VIAL,1.0X100.0 ML VIAL01/07/2012
817NDA/MAL/HDP/4035BAYER SCHERING PHARMASURGIPHARM (U) LIMITEDYASMINDROSPIRENONE + ETHINYLESTRADIOL3MG+0.3MGBAYER PHARMA A.G-MULLERSTRASSE 178, 13353 BERLIN, GERMANY GERMANYORAL SOLID ORDINARY TABLETS1.0X1.0X21.0 TABLET BLISTER01/07/2010
818NDA/MAL/HDP/4187BAYER PHARMA AGSURGIPHARM (U) LIMITEDNORIGYNONESTRADIOL VALERATE +NORETHINDRONE ENANTHATE5 MG+50 MG / MLBAYER PHARMA A.G-MULLERSTRASSE 178, 13353 BERLIN, GERMANY GERMANYPARENTERAL ORDINARY AMPOULES1.0X1.0 ML AMPOULE01/07/1997
819NDA/MAL/HDP/3568BAYER PHARMA AGSURGIPHARM (U) LIMITEDMYCOSPOR CREAMBIFONAZOLE1%W/WBAYER PHARMA AG -51368 LEVERKUSEN GERMANYGERMANYTOPICAL EXTERNAL CREAMS1.0X50.0 G TUBE,1.0X15.0 G TUBE01/07/1997
820NDA/MAL/HDP/3730BAYER PHARMA AGSURGIPHARM (U) LIMITEDAVELOXMOXIFLOXACIN HYDROCHLORIDE400MGBAYER PHARMA AG -51368 LEVERKUSEN GERMANYGERMANYORAL SOLID ORDINARY TABLETS2.0X5.0 TABLET BLISTER,1.0X5.0 TABLET BLISTER01/07/2001
821NDA/MAL/HDP/3768BAYER PHARMA AGSURGIPHARM (U) LIMITEDNIMOTOP 30MGNIMODIPINE30MGBAYER PHARMA AG -51368 LEVERKUSEN GERMANYGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2009
822NDA/MAL/HDP/3789BAYER PHARMA AGSURGIPHARM (U) LIMITEDLEVITRAVARDENAFIL HCL5MGBAYER PHARMA AG -51368 LEVERKUSEN GERMANYGERMANYORAL SOLID ORDINARY TABLETS1.0X1.0X4.0 TABLET BLISTER01/07/2005
823NDA/MAL/HDP/3802BAYER PHARMA AGSURGIPHARM (U) LIMITEDLEVITRA 10MGVARDENAFIL MONOHYDROCHLORIDE TRIHYDRATE10 MGBAYER PHARMA AG -51368 LEVERKUSEN GERMANYGERMANYORAL SOLID ORDINARY TABLETS1.0X1.0X4.0 TABLET BLISTER01/07/2005
824NDA/MAL/HDP/3846BAYER PHARMA AGSURGIPHARM (U) LIMITEDLEVITRAVARDENAFIL HCL20 MGBAYER PHARMA AG -51368 LEVERKUSEN GERMANYGERMANYORAL SOLID ORDINARY TABLETS1.0X1.0X4.0 TABLET BLISTER01/07/2005
825NDA/MAL/HDP/4901BAYER PHARMA AGSURGIPHARM (U) LIMITEDAVELOX IVMOXIFLOXACIN HCL400MG/250MLBAYER PHARMA AG -51368 LEVERKUSEN GERMANYGERMANYPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X250.0 ML BOTTLE01/07/2004
826NDA/MAL/HDP/5469BAYER PHARMA AGSURGIPHARM (U) LIMITEDNIMOTOPNIMODIPINE0.2MG/MLBAYER PHARMA AG -51368 LEVERKUSEN GERMANYGERMANYPARENTERAL ORDINARY I V VIALS1.0X50.0 ML VIAL01/07/2009
827NDA/MAL/HDP/8142BAYER EAST AFRICA LTDSURGIPHARM (U) LIMITEDXARELTORIVAROXABAN2.5MGBAYER PHARMA AG 51368 LEVERKUSEN-BAYER PHARMA AG 51368 LEVERKUSENGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X14.0 TABLET BLISTER01/07/2017
828NDA/MAL/HDP/0748BAYER PHARMASURGIPHARM (U) LIMITEDXARELTO 15MGRIVAROXABAN15MGBAYER PHARMA AG 51368 LEVERKUSEN-BAYER PHARMA AG 51368 LEVERKUSENGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X14.0 TABLET BLISTER01/07/2013
829NDA/MAL/HDP/0750BAYER PHARMASURGIPHARM (U) LIMITEDXARELTO 20MGRIVAROXABAN20MGBAYER PHARMA AG 51368 LEVERKUSEN-BAYER PHARMA AG 51368 LEVERKUSENGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X14.0 TABLET BLISTER01/07/2013
830NDA/MAL/HDP/2167BAYER AGSURGIPHARM (U) LIMITEDMYCOSPOR SOLUTIONBIFONAZOLE10MGBAYER PHARMA AG-D-51368 LEVERKUSEN, GERMANY GERMANYTOPICAL EXTERNAL LIQUIDS1.0X15.0 ML BOTTLE,1.0X50.0 ML BOTTLE01/07/1997
831NDA/MAL/HDP/3714BAYER EAST AFRICA LTDSURGIPHARM (U) LIMITEDADALAT LANIFEDIPINE30MGBAYER PHARMA AG-D-51368 LEVERKUSEN, GERMANY GERMANYORAL SOLID RETARD FILM-COATED TABLETS2.0X14.0 TABLET BLISTER,3.0X10.0 TABLET BLISTER01/07/2001
832NDA/MAL/HDP/4055BAYER PHARMA AGSURGIPHARM (U) LIMITEDBAYER ASPIRIN CARDIOACETYLSALICYLIC ACID100MGBAYER PHARMA AG-D-51368 LEVERKUSEN, GERMANY GERMANYORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X3.0X10.0 TABLET STRIP01/07/2006
833NDA/MAL/HDP/0484KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDPILPLAN PLUSETHINYL ESTRADIOL + LEVONORGESTREL / FERROUS FUMARATE0.03MG+0.15MG/75MGBAYER SCHERING PHARMA AG.-13342, BERLIN GERMANYORAL SOLID ORDINARY TABLETS1.0X10.0X3.0X28.0 TABLET BLISTER01/07/2014
834NDA/MAL/HDP/1529BAYER PHARMA AGSURGIPHARM (U) LIMITEDPROVIRONMESTEROLONE25MGBAYER WEIMAR GMBH & CO. KG-DOBEREINERSTRASSE 20 D-99427 WEIMAR, GERMANY GERMANYORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER01/07/1997
835NDA/MAL/HDP/2219BAYER PHARMA AGSURGIPHARM (U) LIMITEDPRIMOLUT NNORETHISTERONE5MGBAYER WEIMAR GMBH & CO. KG-DOBEREINERSTRASSE 20 D-99427 WEIMAR, GERMANY GERMANYORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X30.0 TABLET CONTAINER01/07/1997
836NDA/MAL/HDP/3901BAYER SCHERING PHARMA FRANCESURGIPHARM (U) LIMITEDMICROGYNON ED FELEVONORGESTREL + ETHINYLESTRADIOL0.15MG + 0.03MGBAYER WEIMER GMBH- DOBEREINERSTRASSE 20, D-99427 WEIMER 2.BAYER PHARMA AG 13342, BERLIN BAYER PHARMA AG -51368 LEVERKUSEN GERMANY FRANCEORAL SOLID ORDINARY TABLETS1.0X3.0X28.0 TABLET BLISTER01/07/2011
837NDA/MAL/HDP/3495BELL SONS & CO.(DRUGGISTS) LTDECHO PHARMACY (U) LIMITEDMENTHODEX COUGH MIXTUREMULTIINGREDIENTN/ABELL SONS & CO (DRUGGISTS) LTD-SLAIDBURN CRES
CHESHIRE HOUSE/GORSEY LA
UNITED KINGDOMORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE01/07/2001
838NDA/MAL/HDP/6629MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A.PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDNEBILET PLUS 5/25NEBIVOLOL+HYDROCHLOROTHIAZIDE5MG+25MGBERLIN-CHEMIE AG, SITE BRITZ (BULK PRODUCTION)-TEMPELHOFER WEG 83
D-12347 BERLIN GERMANY BERLIN-CHEMIE AG/MENARINI-GLIENICKER WEG 125, D-12489 BERLIN GERMANY(BATCH RELEASE)
GERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X14.0 TABLET BLISTER,1.0X1.0X4.0 TABLET BLISTER01/07/2016
839NDA/MAL/HDP/6625MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A.PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDNEBILET PLUS 5/12.5NEBIVOLOL HYDROCHLORIDE + HYDROCHLOROTHIAZIDE5MG + 12.5MGBERLIN-CHEMIE AG, SITE BRITZ (BULK PRODUCTION, -) BERLIN-CHEMIE AG, SITE BRITZ (BULK PRODUCTION, BATCH CONTROL)
TEMPELHOFER WEG 83
D-12347 BERLIN
GERMANY
BERLIN-CHEMIE AG/MENARINI,-GLIENICKER WEG 125, D-12489 BERLIN GERMANY
GERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X14.0 TABLET BLISTER01/07/2016
840NDA/MAL/HDP/6620MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A.PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDNEBILET 5MGNEBIVOLOL HYDROCHLORIDE5MGBERLIN-CHEMIE AG-BERLIN-CHEMIE AG GLIENICKER WEG 125 D-12489 BERLINGERMANYORAL SOLID ORDINARY TABLETS1.0X14.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER01/07/2016
841NDA/MAL/HDP/7120BESINS HEALTHCARE BENELUX SASURGIPHARM (U) LIMITEDANDROGELTESTOSTERONE16.2MG/GBESINS MANUFACTURING BELGIUM (BMB)-GROOT BIJGAARDENSTRAAT, 128. 1620 BELGIUMTOPICAL EXTERNAL EMULSION GELS1.0X88.0 G CANNISTER27/11/2019
842NDA/MAL/HDP/9167AICA LABORATORIES COMPANYECHO PHARMACY (U) LIMITEDZOLEDRONIC ACIDZOLEDRONIC ACID MONOHYDRATE4 MGBEU PHARMACY LABORATORIES LIORAD-27A STREET NUMBER 26402 BETWEEN 264 AND 268, SAN AGUSTIN, LA LISA CUBAPARENTERAL ORDINARY DRY VIALS1.0X25.0 VIAL CARTON27/11/2019
843NDA/MAL/HDP/1532BF BIOSCIENCES LTDHARLEYS UGANDA LIMITEDNOVAPRESSINTERLIPRESSIN1MG/VIALBF BIOSCIENCES LTD. -RAIWIND,PAKISTAN PAKISTANPARENTERAL ORDINARY VIALS1.0X1.0 MG VIAL01/07/2014
844NDA/MAL/HDP/6333BHARAT BIOTECH INTERNATIONAL LIMITEDPILLAR PHARMA LIMITEDREVAC-B+®HEPATITIS B SURFACE ANTIGEN (HBSAG)20MCG/MLBHARAT BIOTECH INTERNATIONAL LTD-GENOME VALLEY, SHAMEERPET MANDAL, RANGAREDDY, TELANGANA STATE-500078 INDIA INDIAPARENTERAL ORDINARY VIALS1.0X1.0X0.5 ML VIAL,1.0X1.0X1.0 ML VIAL,1.0X1.0X10.0 ML VIAL28/03/2019
845NDA/MAL/HDP/4092PRISMA PHARMACEUTICALS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDFLORANORMSACCHAROMYCES BOULARDII250MGBHARAT BIOTECH INTERNATIONAL LTD-TURKPALLY
SHAMEX
500 078
MYDERAHAD
INDIA
INDIAORAL LIQUID ORDINARY SOLUBLE POWDERS1.0X2.0X250.0 MG SACHET,1.0X10.0X250.0 MG SACHET01/07/2010
846NDA/MAL/HDP/7907BHARAT SERUMS AND VACCINES LTDABACUS PHARMA (AFRICA) LIMITEDHUCOG 5000 HPCHORIONIC GONADOTROPHIN5000 I.U/ VIALBHARAT SERUMS & VACCINES LIMITED -PLOT NO. K-27, ADDITIONAL MIDC,
AMBERNATH (E) MAHARASHTRA STATE 421501
INDIAPARENTERAL ORDINARY DRY VIALS1.0X5000.0 I.U VIAL + 1*1ML 0.9%W/V NACL AMBER GLASS AMPOULE01/07/2017
847NDA/MAL/HDP/7090BHARAT SERUMS AND VACCINES LTDABACUS PHARMA (AFRICA) LIMITEDENDOPROSTCARBOPROST TROMETHAMINE125MCG/0.5MLBHARAT SERUMS & VACCINES LTD.-PLOT NO. K–27, JAMBIVILI VILLAGE,
ANAND NAGAR, ADDITIONAL M.I.D.C., AMBERNATH (EAST)-INDIA
INDIAPARENTERAL ORDINARY VIALS1.0X1.0 VIAL CARTON31/01/2018
848NDA/MAL/HDP/6040BHARAT SERUMS AND VACCINES LTDABACUS PHARMA (AFRICA) LIMITEDU-TRYPULINASTATIN100,000 I.UBHARAT SERUMS AND VACCINES LIMITED,-PLOT NO. K-27, ADDITIONAL MIDC,
AMBERNATH (EAST), INDIA
INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0 VIAL CARTON01/07/2017
849NDA/MAL/HDP/0590BHARAT SERUMS AND VACCINES LTDABACUS PHARMA (AFRICA) LIMITEDASNA ANTIVENOM CB.GABONICA/B.ARIENTANS/ B.NASICORNIS/ DENDROASPIS/ POLYEPIS/D.ANGUSTICEPS/ N.NIVEA /N.NLGRCOLLIS/N.HAJE25/25/20/25/25/25/25/25/20/25/20/25 I.UBHARAT SERUMS AND VACCINES LIMITED,-PLOT NO. K-27, ADDITIONAL MIDC,
AMBERNATH (EAST), INDIA
INDIAPARENTERAL ORDINARY VIALS1.0X1.0X10.0 ML VIAL01/07/2012
850NDA/MAL/HDP/0570BHARAT SERUMS AND VACCINES LTDABACUS PHARMA (AFRICA) LIMITEDTETGLOB 250 I.UHUMAN TETANUS IMMUNOGLOBULIN250IUBHARAT SERUMS AND VACCINES LIMITED,-PLOT NO. K-27, ADDITIONAL MIDC,
AMBERNATH (EAST), INDIA
INDIAPARENTERAL ORDINARY I M VIALS1.0X1.0X2.0 ML VIAL (1 DOSE VIAL)01/07/2013
851NDA/MAL/HDP/0553BHARAT SERUMS AND VACCINES LTDABACUS PHARMA (AFRICA) LIMITEDEQUIRABRABIES ANTISERUM1000IU/ 5MLBHARAT SERUMS AND VACCINES LIMITED,-PLOT NO. K-27, ADDITIONAL MIDC,
AMBERNATH (EAST), INDIA
INDIAPARENTERAL ORDINARY VIALS1.0X1.0X5.0 ML VIAL (5 DOSE VIAL)01/07/2013
852NDA/MAL/HDP/1571BHARAT SERUMS AND VACCINES LTDABACUS PHARMA (AFRICA) LIMITEDRHOCLONEMONOCLONAL ANTI-D IMMUNOGLOBULIN300MCGBHARAT SERUMS AND VACCINES LIMITED,-PLOT NO. K-27, ADDITIONAL MIDC,
AMBERNATH (EAST), INDIA
INDIAPARENTERAL ORDINARY DRY VIALS1.0X2.0 ML VIAL (1 DOSE VIAL)01/07/2013
853NDA/MAL/HDP/3711BHARAT SERUMS AND VACCINES LTDABACUS PHARMA (AFRICA) LIMITEDPOLY-MXBPOLYMYXIN B500,000 UNITSBHARAT SERUMS AND VACCINES LIMITED,-PLOT NO. K-27, ADDITIONAL MIDC,
AMBERNATH (EAST), INDIA
INDIAPARENTERAL ORDINARY DRY VIALS1.0X5.0 ML VIAL01/07/2013
854NDA/MAL/HDP/4404BHARAT SERUMS AND VACCINES LTDABACUS PHARMA (AFRICA) LIMITEDFOLIGRAFRECOMBINANT HUMAN FOLLICLE STIMULATING HORMONE75I.U/ VIALBHARAT SERUMS AND VACCINES LIMITED,-PLOT NO. K-27, ADDITIONAL MIDC,
AMBERNATH (EAST), INDIA
INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0 VIAL CARTON01/07/2016
855NDA/MAL/HDP/6137BHARAT SERUMS AND VACCINES LTDABACUS PHARMA (AFRICA) LIMITEDLUPRODEXLEUPROLIDE ACETATE3.75MGBHARAT SERUMS AND VACCINES LIMITED,-PLOT NO. K-27, ADDITIONAL MIDC,
AMBERNATH (EAST), INDIA
INDIAPARENTERAL ORDINARY S C VIALS1.0X1.0 ML VIAL + 1*2ML GLASS AMPOULE OF DILUENT (EACH ML CONTAINS 50MG OF D-MANNITOL AND WFI TO Q.S) + 1 DISPOSABLE SYRINGE, 2 NEEDLES AND 2 ALCOHOL SWABS01/07/2016
856NDA/MAL/HDP/8162BHARAT SERUMS AND VACCINES LTDABACUS PHARMA (AFRICA) LIMITEDHUMOG 75 HPHIGHLY PURIFIED MENOTROPHIN [ CORRESPONDING TO FOLLICLE STIMULATING HORMONE ACTIVITY (FSH) 75 IU + LUTEINISING HORMONE ACTIVITY (LH) 75 IU] /150 I.U75 IU + 75 IU/ 150 I.U VIALBHARAT SERUMS AND VACCINES LTD- PLOT NO. K-27 ADDITIONAL MIDC AMBERNATH (E ) 412 501INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0 VIAL CARTON + 1*1 ML AMPOULE OF 0.9%W/V NACL01/07/2017
857NDA/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 CARTON01/07/2012
858NDA/MAL/HDP/8043DAFRA PHARMA GMBHLABOREX UGANDA LIMITEDRABEZOLRABEPRAZOLE SODIUM20MGB?L?M PHARMACEUTICALS-GOSB 41480 GEBZE-KOCAEL?/TURKETURKEYORAL SOLID ORDINARY TABLETS1.0X14.0 TABLET BLISTER01/07/2017
859NDA/MAL/HDP/4824MISSION PHARMA A/SJOINT MEDICAL STORE (UPMB - UCMB)FERROUS SULPHATE+FOLIC ACIDFERROUS SULPHATE+FOLIC ACID200MG+0.25MGBIO NOVA PHARM LTD.-C-66/1 OKHLA INDUSTIAL AREA PHASE II NEW DEHLIINDIAORAL SOLID ORDINARY COATED TABLETS1.0X1000.0 TABLET CONTAINER01/07/2008
860NDA/MAL/HDP/1026BIOCON LTDABACUS PHARMA (AFRICA) LIMITEDINSUGEN R (REGULAR)INSULIN HUMAN100 IU/MLBIOCON LIMITED-SPECIAL ECONOMIC ZONE PLOT 204 PHASE IV BOMMASANDRA JIGANI LINK ROADINDIAPARENTERAL ORDINARY S C VIALS1.0X10.0 ML VIAL,1.0X1.0X5.0X3.0 ML CARTRIDGE01/07/2012
861NDA/MAL/HDP/1027BIOCON LTDABACUS PHARMA (AFRICA) LIMITEDINSUGEN-N (NPH)INSULIN HUMAN100 IU/MLBIOCON LIMITED-SPECIAL ECONOMIC ZONE PLOT 204 PHASE IV BOMMASANDRA JIGANI LINK ROADINDIAPARENTERAL ORDINARY S C VIALS1.0X10.0 ML VIAL,1.0X1.0X5.0X3.0 ML CARTRIDGE01/07/2012
862NDA/MAL/HDP/1028BIOCON LTDABACUS PHARMA (AFRICA) LIMITEDINSUGEN -30/70 (BIPHASIC)INSULIN HUMAN30/70I.U/MLBIOCON LIMITED-SPECIAL ECONOMIC ZONE PLOT 204 PHASE IV BOMMASANDRA JIGANI LINK ROADINDIAPARENTERAL ORDINARY S C VIALS1.0X10.0 ML VIAL,1.0X1.0X5.0X3.0 ML CARTRIDGE01/07/2012
863NDA/MAL/HDP/6145MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIAKIMSY MEDS LTDENDULIN SELECTINSULIN GLARGINE(R-DNA ORGIN)100I.U/MLBIOCON LIMITED-SPECIAL ECONOMIC ZONE,
PLOT NO.2-4, PHASE IV, BOMMASANDRA- JIGANI LINK ROAD BANGALORE-560 099 INDIA
INDIAPARENTERAL ORDINARY PRE-FILLED PENS1.0X3.0 ML PREFILLED PEN01/07/2016
864NDA/MAL/HDP/6147MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIAKIMSY MEDS LTDENDULIN VAILINSULIN GLARGINE (R-DNA ORIGIN)100I.U/MLBIOCON LIMITED-SPECIAL ECONOMIC ZONE,
PLOT NO.2-4, PHASE IV, BOMMASANDRA- JIGANI LINK ROAD BANGALORE-560 099 INDIA
INDIAPARENTERAL ORDINARY S C VIALS1.0X10.0 ML VIAL01/07/2016
865NDA/MAL/HDP/6047MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIAKIMSY MEDS LTDHERTRAZ 150TRASTUZUMAB (R-DNA ORIGIN)150MGBIOCON LIMITED-SPECIAL ECONOMIC ZONE,
PLOT NO.2-4, PHASE IV, BOMMASANDRA- JIGANI LINK ROAD
BANGALORE-560 099
INDIAPARENTERAL ORDINARY INFUSION DRY VIALS/BOTTLES1.0X150.0 MG VIAL ,1X10ML VIAL OF WFI01/07/2017
866NDA/MAL/HDP/8244MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIAKIMSY MEDS LTDHERTRAZ 440TRASTUZUMAB (R-DNA ORIGIN)440MGBIOCON LIMITED-SPECIAL ECONOMIC ZONE,
PLOT NO.2-4, PHASE IV, BOMMASANDRA- JIGANI LINK ROAD
BANGALORE-560 099
INDIAPARENTERAL ORDINARY DRY VIALS1.0X440.0 MG VIAL ,1X2X10ML VIALS OF WFI01/07/2017
867NDA/MAL/HDP/8156TATA UGANDA LIMITEDGITTOES PHARMACEUTICALS LIMITEDDIPHTHERIA + TETANUS + PERTUSSIS + HEPATITIS B + HAEMOPHILUS TYPE B CONJUGATE VACCINEDIPHTHERIA + TETANUS + PERTUSSIS + HEPATITIS B + HAEMOPHILUS TYPE B CONJUGATE VACCINE25 LF (? 30 IU)+5.5 LF (? 40 IU)+16 IOU (? 4.0 IU)+12.5MCG+11MCGBIOLOGICAL E LTD-PLOT NO.1, S.P BIOTECHNOLOGY PARK, PHASE II KOLTHER (V), SHAMEERPET(M), RANGA REDDY(DIST), ANDHRA PRADESH, INDIA 500078 INDIAPARENTERAL ORDINARY I M VIALS1.0X48.0X0.5 ML VIAL (1 DOSE VIAL),1.0X24.0X5.0 ML VIAL (10 DOSE VIAL)01/07/2014
868NDA/MAL/HDP/0271BIOLOGICAL E. LTDGITTOES PHARMACEUTICALS LIMITEDBETTTETANUS VACCNE ADSORBED40 I.UBIOLOGICAL E LTD-PLOT NO.1, S.P BIOTECHNOLOGY PARK, PHASE II KOLTHER (V), SHAMEERPET(M), RANGA REDDY(DIST), ANDHRA PRADESH, INDIA 500078 INDIAPARENTERAL ORDINARY AMPOULES1.0X20.0X10.0 ML AMPOULE,1.0X24.0X10.0 ML AMPOULE,1.0X5.0 ML VIAL (10 DOSES)01/07/2001
869NDA/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)01/07/2015
870NDA/MAL/HDP/8927BIOLOGICAL E. LTDGITTOES PHARMACEUTICALS LIMITEDDIPHTHERIA AND TETANUS VACCINE (ADSORBED REDUCED ANTIGEN(S) CONTENT)DIPHTHERIA TOXOID + TETANUS TOXOID2 LF ( NOT LESS THAN 2 IU) + 8.8 LF (NOT LESS THAN 20 IU)/ 0.5MLBIOLOGICAL E. LIMITED--PLOT NO.1 SHAPOORJI PALLONJI BIOTECH PARK
PHASE II, KOLTHUR VILLAGE, SHAMEERPET,
MANDAL, R.R. DISTRICT, ANDRA PRADESH 500078, INDIA
INDIAPARENTERAL ORDINARY VIALS1.0X24.0X1.0X10.0 DOSE VIAL,1.0X48.0X1.0 DOSE VIAL25/07/2018
871NDA/MAL/HDP/6245BIOLOGICAL E. LTDABACUS PHARMA (AFRICA) LIMITEDCOSCOPIN LINCTUSNOSCAPINE + CHLORPHENIRAMINE MALEATE + SODIUM CITRATE + AMMONIUM CHLORIDE7MG+2 MG+ 3.25 MG+28 MG/5 ML.BIOLOGICAL E. LTD -PLOT NO.31 & 32 PHARMA CITY SELAQUI INDUSTRIAL AREA SELAQUI DEHRADUN-248 197 UTTARAKHAND,INDIA INDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE01/07/2016
872NDA/MAL/HDP/6338BIOTON S.A.BHL HEALTHCARE LIMITEDGENSULIN M30 (30/70)INSULIN HUMAN OF RECOMBINANT DNA ORIGIN (30% SOLUBLE INSULIN + 70% ISOPHANE INSULIN)100 IU/MLBIOTON S.A-MACIERZYSZ, POZNANSKA 12 STR., 05-850 OZAROW MAZOWIECKI POLANDPARENTERAL ORDINARY S C VIALS1.0X1.0X10.0 ML VIAL,1.0X5.0X3.0 ML CARTRIDGE28/03/2019
873NDA/MAL/HDP/6343BIOTON S.A.BHL HEALTHCARE LIMITEDGENSULIN NISOPHANE HUMAN HUMAN OF RECOMBINANT DNA ORIGIN100 IU/MLBIOTON S.A-MACIERZYSZ, POZNANSKA 12 STR., 05-850 OZAROW MAZOWIECKI POLANDPARENTERAL ORDINARY S C VIALS1.0X1.0X10.0 ML VIAL,1.0X5.0X3.0 ML CARTRIDGE28/03/2019
874NDA/MAL/HDP/6346BIOTON S.A.BHL HEALTHCARE LIMITEDGENSULIN RSOLUBLE HUMAN INSULIN OF RECOMBINANT DNA ORIGIN100 IU/MLBIOTON S.A-MACIERZYSZ, POZNANSKA 12 STR., 05-850 OZAROW MAZOWIECKI POLANDPARENTERAL ORDINARY S C VIALS1.0X1.0X10.0 ML VIAL,1.0X5.0X3.0 ML CARTRIDGE28/03/2019
875NDA/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 BLISTER01/07/2007
876NDA/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 BLISTER01/07/2007
877NDA/MAL/HDP/1312BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDSLIPIZEM- 2.5DIAZEPAM2.5MGBLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIAINDIARECTAL SYSTEMIC PAEDIATRIC SUPPOSITORIES1.0X5.0 SUPPOSITORY BLISTER01/07/2007
878NDA/MAL/HDP/1220BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDLONARTARTEMETHER + LUMEFANTRINE180 MG + 1080 MGBLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X60.0 ML BLISTER01/07/2008
879NDA/MAL/HDP/1215BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDGYNANFORT VAGINAL PESSARYMETRONIDAZOLE+NEOMYCIN SULPHATE+NYSTATIN500MG+65,000I.U+100,000I.UBLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIAINDIAVAGINAL SUPPOSITORIES1.0X10.0 TABLET BLISTER01/07/2013
880NDA/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 BLISTER01/07/2013
881NDA/MAL/HDP/0366BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDAGYCIN 500AZITHROMYCIN500MGBLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0 TABLET BLISTER01/07/2014
882NDA/MAL/HDP/0363BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDAGYCINAZITHROMYCIN250MGBLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X6.0 TABLET BLISTER01/07/2014
883NDA/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 BLISTER01/07/2007
884NDA/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 BLISTER01/07/2007
885NDA/MAL/HDP/3130BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDGSUNATE 200 SUPPOSITORYARTESUNATE200MGBLISS 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 SUPPOSITORIES1.0X6.0 SUPPOSITORY STRIP01/07/2009
886NDA/MAL/HDP/3736PHARMAVET LTDDELMAW ENTERPRISES LIMITEDRECTOL 125 SUPPOSITORYPARACETAMOL125MGBLISS GVS PHARMA LIMITED-PLOT NO. 10/11, SURVEY NO. 38/1, DEWAN UDYOG NAGAR, ALIYALI VILLAGE INDIARECTAL SYSTEMIC SUPPOSITORIES1.0X1.0X5.0 SUPPOSITORY BLISTER01/07/2007
887NDA/MAL/HDP/8153BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDASNORBIN-1000VITAMIN C1000MGBLISS GVS PHARMA LTD,-PLOT 10, SURVEY NO. 38/1, DEWAN UDYONG NAGAR ALIYALI VILLAGE TAL PALGHAR DIST. THANE - INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X4.0X4.0 TABLET BLISTER26/11/2019
888NDA/MAL/HDP/2809BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDMAITRIPEG 150OBP/ PEG 1000BP1280MG/ 320MGBLISS GVS PHARMA LTD-PLOT.NO 10,SURVEY NO 38/1,DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR, TAL: PALGHAR DIST.THANE, MAHARASHTRA-INDIA INDIAVAGINAL TABLETS1.0X5.0 PESSARY STRIP01/07/2008
889NDA/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 BOTTLE01/07/2008
890NDA/MAL/HDP/2450BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDTODAY PESSARYNONOXYNOL-95%W/VBLISS GVS PHARMA LTD-PLOT.NO 10,SURVEY NO 38/1,DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR, TAL: PALGHAR DIST.THANE, MAHARASHTRA-INDIA INDIAVAGINAL TABLETS1.0X5.0 PESSARY BLISTER01/07/2011
891NDA/MAL/HDP/1925BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDG - ALFENAC- PACECLOFENAC + PARACETAMOL100MG + 500MGBLISS GVS PHARMA LTD-PLOT.NO 10,SURVEY NO 38/1,DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR, TAL: PALGHAR DIST.THANE, MAHARASHTRA-INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER01/07/2014
892NDA/MAL/HDP/3340BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDPOVEDPOVIDONE IODINE200MGBLISS GVS PHARMA LTD-PLOT.NO 10,SURVEY NO 38/1,DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR, TAL: PALGHAR DIST.THANE, MAHARASHTRA-INDIA INDIAVAGINAL TABLETS1.0X2.0X7.0 PESSARY STRIP01/07/2008
893NDA/MAL/HDP/3600BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDP-ALAXIN TABLETSDIHYDROARTEMISININ + PIPERAQUINE PHOSPHATE40MG + 320MGBLISS GVS PHARMA LTD-PLOT.NO 10,SURVEY NO 38/1,DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR, TAL: PALGHAR DIST.THANE, MAHARASHTRA-INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X9.0 TABLET BLISTER,1.0X6.0 TABLET BLISTER,1.0X12.0 TABLET BLISTER,1.0X15.0 TABLET BLISTER01/07/2008
894NDA/MAL/HDP/8637BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDAGYCINAZITHROMYCIN DIHYDRATE40MG/MLBLISS 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/DROPS1.0X1.0X15.0 ML BOTTLE28/03/2018
895NDA/MAL/HDP/3803BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDDICLODYNE SUPPOSITORYDICLOFENAC SODIUM100MGBLISS GVS PHARMA LTD-PLOT.NO 10,SURVEY NO 38/1,DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR, TAL: PALGHAR DIST.THANE, MAHARASHTRA-INDIA INDIARECTAL SYSTEMIC ADULT SUPPOSITORIES1.0X5.0 SUPPOSITORY BLISTER01/07/2007
896NDA/MAL/HDP/4839PHARMAVET LTDDELMAW ENTERPRISES LIMITEDANOMEXZINC OXIDE+LIDOCAINE+HYDROCORTISONE+ALLANTOIN5%W/W+3%W/W+0.25%W/W+0.5%W/WBLISS GVS PHARMA LTD-PLOT.NO 10,SURVEY NO 38/1,DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR, TAL: PALGHAR DIST.THANE, MAHARASHTRA-INDIA INDIARECTAL SYSTEMIC SUPPOSITORIES1.0X1.0X5.0 SUPPOSITORY BLISTER,1.0X2.0X5.0 SUPPOSITORY BLISTER01/07/2007
897NDA/MAL/HDP/5169BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDGVGYL SUPPOSITORYMETRONIDAZOLE BP500MGBLISS GVS PHARMA LTD-PLOT.NO 10,SURVEY NO 38/1,DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR, TAL: PALGHAR DIST.THANE, MAHARASHTRA-INDIA INDIARECTAL SYSTEMIC SUPPOSITORIES1.0X2.0X5.0 SUPPOSITORY BLISTER01/07/2007
898NDA/MAL/HDP/5274BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDECOZOLEECONAZOLE150MGBLISS GVS PHARMA LTD-PLOT.NO 10,SURVEY NO 38/1,DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR, TAL: PALGHAR DIST.THANE, MAHARASHTRA-INDIA INDIAVAGINAL TABLETS1.0X3.0 PESSARY STRIP01/07/2008
899NDA/MAL/HDP/6176BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDG-GLUTAMIN PLUSVITAMIN B1 +B6+B12 WITH L-GLUTAMIC ACID100MG+50MG+100MCG+50MGBLISS GVS PHARMA LTD-PLOT.NO 10,SURVEY NO 38/1,DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR, TAL: PALGHAR DIST.THANE, MAHARASHTRA-INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X10.0 TABLET BLISTER01/07/2010
900NDA/MAL/HDP/8643ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDARTESUNATE 60MGARTESUNATE60MGBLISS INDAS LIFESCIENCE P. LTD..-PLOT 73-76, SILVER INDUSTRIAL ESTATE, BHIMPORE, DAMAN INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0X60.0 MG VIAL + 1*1*5ML AMPOULE OF 0.9%W/V NACL + 1*1*1ML AMPOULE OF 5%W/V NAHCO328/03/2018
901NDA/MAL/HDP/6349BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDGSUNATE -120ARTESUNATE120MGBLISS INDASI LIFESCINCES PRIVATE LIMITED - -PLOT 73-76 SILVER INDUSTRIAL ESTATE,
BHIMPORE, DAMAN 396 210, INDIA
INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0 VIAL CARTON + 1*10ML 0.9%W/W SODIUM CHLORIDE SOLUTION AMPOULE + 1*2ML 5.0%W/W SODIUM BICARBONATE SOLUTION AMPOULE26/09/2018
902NDA/MAL/HDP/1806BLUE CROSS LABORATORIES LIMITEDSTAR PHARMACEUTICALS LTDBLUMOX PAMOXYCILLIN125MGBLUE CROSS LABORATORIES LIMITED-A-12 MIDC AMBAD-NASHIK-422010 MAHARASHTRA STATE, INDIA INDIAORAL SOLID ORDINARY TABLETS10.0X10.0X2.0 TABLET STRIP01/07/2000
903NDA/MAL/HDP/2617BLUE CROSS LABORATORIES LIMITEDSTAR PHARMACEUTICALS LTDBLUDROX TABLETS DISPERSABLECEFADROXIL250MGBLUE CROSS LABORATORIES LIMITED-A-12 MIDC AMBAD-NASHIK-422010 MAHARASHTRA STATE, INDIA INDIAORAL SOLID ORDINARY TABLETS10.0X10.0 TABLET STRIP01/07/2001
904NDA/MAL/HDP/6679BLUE CROSS LABORATORIES LIMITEDSTAR PHARMACEUTICALS LTDWOMIBAN TABLETSALBENDAZOLE400MGBLUE CROSS LABORATORIES LTD-A-12, M.I.D.C AMBAD NASHIK-422010 BLUE CROSS LABORATORIES LTD-L-17, VERNA INDUSTRIAL ESTATE,VERNA GOA-403722 INDIAORAL SOLID ORDINARY CHEWABLE TABLETS1.0X1.0 TABLET STRIP01/07/1997
905NDA/MAL/HDP/8443BLUE CROSS LABORATORIES LTDSTAR PHARMACEUTICALS LTDEKON-D TABLETSCETIRIZINE10 MGBLUE CROSS LABORATORIES LTD-L-17, VERNA INDUSTRIAL ESTATE,VERNA GOA-403722 INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET STRIP,1.0X10.0X12.0 TABLET STRIP01/07/2001
906NDA/MAL/HDP/1821BLUE CROSS LABORATORIES LTDSTAR PHARMACEUTICALS LTDMEFTAL 500 TABLETSMEFENAMIC ACID500MGBLUE CROSS LABORATORIES LTD-L-17, VERNA INDUSTRIAL ESTATE,VERNA GOA-403722 INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET STRIP01/07/1997
907NDA/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 TUBE01/07/2007
908NDA/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 BOTTLE01/07/2007
909NDA/MAL/HDP/4715BLUE CROSS LABARATORIES LIMITEDSTAR PHARMACEUTICALS LTDMEFTAL FORTEMEFENAMIC ACID + PARACETAMOL500MG + 450MGBLUE CROSS LABORATORIES LTD-L-17, VERNA INDUSTRIAL ESTATE,VERNA GOA-403722 INDIAORAL SOLID ORDINARY TABLETS1.0X5.0X2.0X10.0 TABLET BLISTER01/07/2008
910NDA/MAL/HDP/4717BLUE CROSS LABARATORIES LIMITEDSTAR PHARMACEUTICALS LTDMEFTAL-SPASMEFENAMIC ACID + DICYCLOMINE HYDROCHLORIDE250MG + 10MGBLUE CROSS LABORATORIES LTD-L-17, VERNA INDUSTRIAL ESTATE,VERNA GOA-403722 INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X20.0 TABLET BLISTER01/07/2008
911NDA/MAL/HDP/6678BLUE CROSS LABORATORIES LIMITEDSTAR PHARMACEUTICALS LTDTUSQ-DXCHLORPHENIRAMINE MALEATE + DEXTROMETHORPHAN HBR + PHENYLEPHRINE2MG/5ML + 15MG/5ML + 5MG/5MLBLUECROSS LABORATORIES LIMITED-A-12,M.I.D.C,NASHIK 422010 INDIAORAL LIQUID ORDINARY SYRUPS1.0X1.0X100.0 ML BOTTLE01/07/2008
912NDA/MAL/HDP/6753BLUE CROSS LABARATORIES LIMITEDSTAR PHARMACEUTICALS LTDTUSQ X SYRUPTERBUTALINE+BROMHEXINE+GUAIFENESIN1.25MG+4MG+50MG/5MLBLUECROSS LABORATORIES LIMITED-A-12,M.I.D.C,NASHIK 422010 INDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE01/07/2001
913NDA/MAL/HDP/8694MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDERBITUXCETUXIMAB5MG/MLBOEHRINGER INGELHEIM PHARMA GMBH & CO. KG - -BIRKENDORFER STRASSE 65, 88397, BIBERACH AN DER RISS, GERMANY. GERMANYPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X1.0X20.0 ML VIAL01/07/2018
914NDA/MAL/HDP/6805BOEHRINGER INGELHEIM INTERNATIONAL GMBHSURGIPHARM (U) LIMITEDMOBIC 7.5 TABLETSMELOXICAM7.5MGBOEHRINGER INGELHEIM PHARMA GMBH & CO. KG.,-BIRKENDORFER STRASSE 65, 88397, BIBERACH AN DER RISS GERMANYORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET CONTAINER,1.0X3.0X10.0 TABLET BLISTER07/01/2002
915NDA/MAL/HDP/0001INGELHEIM PHARMACEUTICAL LTDSURGIPHARM (U) LIMITEDMICARDIS 40TELMISARTAN40MGBOEHRINGER INGELHEIM PHARMA GMBH & CO. KG.,-BIRKENDORFER STRASSE 65, 88397, BIBERACH AN DER RISS GERMANYORAL SOLID ORDINARY TABLETS1.0X4.0X7.0 TABLET BLISTER01/07/1997
916NDA/MAL/HDP/0018INGELHEIM PHARMACEUTICAL LTDSURGIPHARM (U) LIMITEDCO-MICARDISTELMISARTAN + HYDROCHLOROTHIAZIDE40MG + 12.5MGBOEHRINGER INGELHEIM PHARMA GMBH & CO. KG.,-BIRKENDORFER STRASSE 65, 88397, BIBERACH AN DER RISS GERMANYORAL SOLID ORDINARY TABLETS1.0X4.0X7.0 TABLET BLISTER01/07/1997
917NDA/MAL/HDP/0032INGELHEIM PHARMACEUTICAL LTDSURGIPHARM (U) LIMITEDCO-MICARDISTELMISARTAN + HYDROCHLOROTHIZIDE80MG + 12.5MGBOEHRINGER INGELHEIM PHARMA GMBH & CO. KG.,-BIRKENDORFER STRASSE 65, 88397, BIBERACH AN DER RISS GERMANYORAL SOLID ORDINARY TABLETS1.0X4.0X7.0 TABLET BLISTER01/07/2013
918NDA/MAL/HDP/0011INGELHEIM PHARMACEUTICAL LTDSURGIPHARM (U) LIMITEDMICARDIS 80TELMISARTAN80MGBOEHRINGER INGELHEIM PHARMA GMBH & CO. KG.,-BIRKENDORFER STRASSE 65, 88397, BIBERACH AN DER RISS GERMANYORAL SOLID ORDINARY TABLETS1.0X4.0X7.0 TABLET BLISTER01/07/2015
919NDA/MAL/HDP/9145BOEHERINGER INGELHEIM INTERNATIONAL GMBHSURGIPHARM (U) LIMITEDMETALYSE®TENECTAPLASE50MG/10MLBOEHRINGER INGELHEIM PHARMA GMBH & CO. KG.,-BIRKENDORFER STRASSE 65, 88397, BIBERACH AN DER RISS GERMANYPARENTERAL ORDINARY VIALS1.0X20.0 ML VIAL27/11/2019
920NDA/MAL/HDP/6352BRAWN LABORATORIES LTDTATA UGANDA LIMITEDOMIPIN-20OMEPRAZOLE20MGBRAWN LABORATORIES LTD .-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA INDIAORAL SOLID ORDINARY OTHER CAPSULES1.0X10.0X10.0 CAPSULE STRIP28/03/2019
921NDA/MAL/HDP/6859BRAWN LABORATORIES LTDTATA UGANDA LIMITEDBRUVEL-500 TABLETSLEVOFLOXACIN HEMIHYDRATE500MGBRAWN LABORATORIES LTD..-13,NEW INDUSTRIAL TOWNSHIP, FARIDABAD-121 001,HARYANA -INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER26/09/2018
922NDA/MAL/HDP/6871BRAWN LABORATORIES LTDTATA UGANDA LIMITEDVIVAX 100SILDENAFIL100MGBRAWN LABORATORIES LTD..-13,NEW INDUSTRIAL TOWNSHIP, FARIDABAD-121 001,HARYANA -INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X4.0 TABLET BLISTER26/09/2018
923NDA/MAL/HDP/6873BRAWN LABORATORIES LTDTATA UGANDA LIMITEDROXITHIN TABLETSROXITHROMYCIN150MGBRAWN LABORATORIES LTD..-13,NEW INDUSTRIAL TOWNSHIP, FARIDABAD-121 001,HARYANA -INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER26/09/2018
924NDA/MAL/HDP/6431BRAWN LABORATORIES LTDTATA UGANDA LIMITEDBRUMOX 125AMOXICILLIN TRIHYDRATE125MG/5MLBRAWN LABORATORIES LTD.-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE01/07/2017
925NDA/MAL/HDP/6433BRAWN LABORATORIES LTDTATA UGANDA LIMITEDFICYC CREAMACICLOVIR5%W/WBRAWN LABORATORIES LTD.-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA INDIATOPICAL EXTERNAL CREAMS1.0X10.0 G TUBE01/07/2017
926NDA/MAL/HDP/6435BRAWN LABORATORIES LTDTATA UGANDA LIMITEDFIMABUTE 200CEFIXIME TRIHYDRATE200MGBRAWN LABORATORIES LTD.-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER01/07/2017
927NDA/MAL/HDP/6447BRAWN LABORATORIES LTDTATA UGANDA LIMITEDAZIBRU 500AZITHROMYCIN DIHYDRATE500MGBRAWN LABORATORIES LTD.-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0 TABLET BLISTER01/07/2017
928NDA/MAL/HDP/6455BRAWN LABORATORIES LTDTATA UGANDA LIMITEDFICYC TABLETSACYCLOVIR200MGBRAWN LABORATORIES LTD.-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2017
929NDA/MAL/HDP/6857BRAWN LABORATORIES LTDTATA UGANDA LIMITEDBRUCIPRO TABLETSCIPROFLOXACIN500MGBRAWN LABORATORIES LTD.-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS10.0X10.0 TABLET BLISTER29/11/2017
930NDA/MAL/HDP/6862BRAWN LABORATORIES LTDTATA UGANDA LIMITEDDITS GELDICLOFENAC DIETHYLAMINE1%W/WBRAWN LABORATORIES LTD.-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA INDIATOPICAL EXTERNAL GELS AND SOLS1.0X15.0 G TUBE,1.0X10.0 G TUBE01/07/2017
931NDA/MAL/HDP/6865BRAWN LABORATORIES LTDTATA UGANDA LIMITEDDITS INJECTIONDICLOFENAC SODIUM25MG/MLBRAWN LABORATORIES LTD.-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA INDIAPARENTERAL ORDINARY AMPOULES1.0X5.0X3.0 ML AMPOULE29/11/2017
932NDA/MAL/HDP/6870BRAWN LABORATORIES LTDTATA UGANDA LIMITEDHYDROSONE 100MGHYDROCORTISONE SODIUM SUCCINATE100MGBRAWN LABORATORIES LTD.-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0 VIAL CARTON (1*100MG GLASS VIAL + 1*2ML AMP WFI)29/11/2017
933NDA/MAL/HDP/6872BRAWN LABORATORIES LTDTATA UGANDA LIMITEDNETRACORTIL EYE/EAR SUSPENSIONOXYTETRACYCLINE HYDROCHLORIDE +HYDROCORTISONE ACETATE+POLYMYXIN B SULPHATE10MG+5MG+10000I.UBRAWN LABORATORIES LTD.-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA INDIAOPHTHALMIC SUSPENSIONS1.0X5.0 ML BOTTLE01/07/2017
934NDA/MAL/HDP/6874BRAWN LABORATORIES LTDTATA UGANDA LIMITEDCEZIN TABLETSCETIRIZINE HYDROCHLORIDE10MGBRAWN LABORATORIES LTD.-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2017
935NDA/MAL/HDP/6875BRAWN LABORATORIES LTDTATA UGANDA LIMITEDBRUMOX-250 CAPSULESAMOXICILLIN TRIHYDRATE250MGBRAWN LABORATORIES LTD.-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA INDIAORAL SOLID ORDINARY CAPSULES10.0X10.0 CAPSULE BLISTER01/07/2017
936NDA/MAL/HDP/8206BRAWN LABORATORIES LTDTATA UGANDA LIMITEDBRULEXINCEFALEXIN MONOHYDRATE125MG/5MLBRAWN LABORATORIES LTD.-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE01/07/2017
937NDA/MAL/HDP/0892ASTRA ZENECAMACNAUGHTON LIMITEDONGLYZASAXAGLIPTIN2.5MGBRISTOL-4601 HIGHWAY 62 EAST MOUNT VERNON INDIANA 47620
USA
UNITED STATESORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET CONTAINER01/07/2013
938NDA/MAL/HDP/6218ASTRA ZENECAMACNAUGHTON LIMITEDFORXIGADAPAGLIFLOZIN10MGBRISTOL-4601 HIGHWAY 62 EAST MOUNT VERNON INDIANA 47620
USA
UNITED STATESORAL SOLID ORDINARY TABLETS1.0X2.0X14.0 TABLET BLISTER01/07/2016
939NDA/MAL/HDP/0904ASTRA ZENECAMACNAUGHTON LIMITEDONGLYZASAXAGLIPTIN5MGBRISTOL-4601 HIGHWAY 62 EAST MOUNT VERNON INDIANA 47620
USA ASTRA ZENECA UK LIMITED-ASTRAZENECA UK LIMITED SILK ROAD BUSINESS PARK, MACCLES FIELD,CHESHIRE SK 10 2NA,
UNITED STATESORAL SOLID ORDINARY FILM-COATED TABLETS1.0X30.0 TABLET CONTAINER01/07/2013
940NDA/MAL/HDP/6575BROOKES PHARMA (PRIVATE) LIMITEDHARLEYS UGANDA LIMITEDSENSOCAINBUPIVACAINE HYDROCHLORIDE0.75% W/VBROOKES PHARMA (PRIVATE) LIMITED-58-59, SECTOR NO. 15, KORANGI INDUSTRIAL AREA, KARACHI-74900 PAKISTANPARENTERAL ORDINARY AMPOULES1.0X5.0X2.0 ML AMPOULE28/08/2019
941NDA/MAL/HDP/7209BROOKES PHARMA (PRIVATE) LIMITEDHARLEYS UGANDA LIMITEDMINOXIN SOLUTIONMINOXIDIL2%W/VBROOKES PHARMA (PRIVATE) LIMITED-58-59, SECTOR NO. 15, KORANGI INDUSTRIAL AREA, KARACHI-74900 PAKISTANTOPICAL EXTERNAL LIQUIDS1.0X1.0X60.0 ML BOTTLE26/09/2018
942NDA/MAL/HDP/7213BROOKES PHARMA (PRIVATE) LIMITEDHARLEYS UGANDA LIMITEDACURONATRACURIUM BESYLATE10MG /MLBROOKES PHARMA (PRIVATE) LIMITED-58-59, SECTOR NO. 15, KORANGI INDUSTRIAL AREA, KARACHI-74900 PAKISTANPARENTERAL ORDINARY AMPOULES1.0X5.0X3.0 ML AMPOULE28/08/2019
943NDA/MAL/HDP/7463BROOKES PHARMA (PRIVATE) LIMITEDHARLEYS UGANDA LIMITEDACURONATRACURIUM BESYLATE10MG/MLBROOKES PHARMA (PRIVATE) LIMITED-58-59, SECTOR NO. 15, KORANGI INDUSTRIAL AREA, KARACHI-74900 PAKISTANPARENTERAL ORDINARY AMPOULES1.0X5.0X5.0 ML AMPOULE28/08/2019
944NDA/MAL/HDP/7467BROOKES PHARMA (PRIVATE) LIMITEDHARLEYS UGANDA LIMITEDTEZOLE CREAMKETOCONAZOLE20 MGBROOKES PHARMA (PRIVATE) LIMITED-58-59, SECTOR NO. 15, KORANGI INDUSTRIAL AREA, KARACHI-74900 PAKISTANTOPICAL EXTERNAL CREAMS1.0X10.0 G TUBE28/08/2019
945NDA/MAL/HDP/6897BROOKES PHARMACEUTICAL LABORATORIES LHARLEYS UGANDA LIMITEDPYODINE GARGLE & MOUTH WASHPOVIDONE IODINE1G/100MLBROOKES PHARMACEUTICALS LABORATORIES (PAKISTAN) LTD-PLOT 58 SECTOR 15 KORANGI
INDUSTRIAL AREA, KARACHI-PAKISTAN
PAKISTANORAL TOPICAL LIQUIDS1.0X60.0 ML BOTTLE01/07/2006
946NDA/MAL/HDP/2026BROOKES PHARMACEUTICAL LABORATORIES LHARLEYS UGANDA LIMITEDCORAM 10MGAMLODIPINE BESYLATE10MGBROOKES PHARMACEUTICALS LABORATORIES (PAKISTAN) LTD-PLOT 58 SECTOR 15 KORANGI
INDUSTRIAL AREA, KARACHI-PAKISTAN
PAKISTANORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER01/07/2009
947NDA/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 BOTTLE01/07/2006
948NDA/MAL/HDP/6057BROOKES PHARMACEUTICAL LABORATORIES LHARLEYS UGANDA LIMITEDCORAM 5MGAMLODIPINE BESYLATE5MGBROOKES PHARMACEUTICALS LABORATORIES (PAKISTAN) LTD-PLOT 58 SECTOR 15 KORANGI
INDUSTRIAL AREA, KARACHI-PAKISTAN
PAKISTANORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER01/07/2009
949NDA/MAL/HDP/8324CACHET PHARMACEUTICALS PRIVATE LIMITEDASTRA PHARMA (U) LIMITEDLOOBID TABLETSOFLOXACIN + ORNIDAZOLE200MG + 500 MGCACHET PHARMACEUTICAL PVT LTD. HIMACHAL-THANA, BADDI, HIMACHAL PRADESH-173 205,
INDIA
INDIAORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER29/11/2017
950NDA/MAL/HDP/7316CACHET PHARMACEUTICALS PVT LIMITEDASTRA PHARMA (U) LIMITEDI-UP TABLETSFERROUS ASCORBATE + FOLIC ACID100MG + 1.5MGCACHET PHARMACEUTICAL PVT LTD. -VILLAGE-THANA, NEAR BADDI, TEHSIL_NALAGARH, DIST. SOLAN, HIMACHAL PRADESH - 173205 INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER27/11/2019
951NDA/MAL/HDP/7317CACHET PHARMACEUTICALS PVT LIMITEDASTRA PHARMA (U) LIMITEDEMITINO TABLETS 8MGONDANSETRON8MGCACHET PHARMACEUTICAL PVT LTD. -VILLAGE-THANA, NEAR BADDI, TEHSIL_NALAGARH, DIST. SOLAN, HIMACHAL PRADESH - 173205 INDIAORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER27/11/2019
952NDA/MAL/HDP/6715CACHET PHARMACEUTICALS PVT LTDASTRA PHARMA (U) LIMITEDCAZITHROAZITHROMYCIN200MG/5MLCACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X1.0X15.0 ML BOTTLE01/07/2009
953NDA/MAL/HDP/6717CACHET PHARMACEUTICALS PVT LTDASTRA PHARMA (U) LIMITEDCAZITHROAZITHROMYCIN500MGCACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X1.0X3.0 TABLET BLISTER01/07/2011
954NDA/MAL/HDP/6734CACHET PHARMACEUTICALS PVT LTDASTRA PHARMA (U) LIMITEDEASCOFBROMHEXIDINE HCL + SALBUTAMOL SULPHATE + GUAIPHENESIN24MG/100ML + 42MG/100ML + 1G/MLCACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIAINDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE01/07/2009
955NDA/MAL/HDP/6700CACHET PHAMACUITICALS PVT LTDASTRA PHARMA (U) LIMITEDARTIMEDDICLOFENAC SODIUM50MGCACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIAINDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2009
956NDA/MAL/HDP/6765CACHET PHARMACEUTICALS PVT LTDASTRA PHARMA (U) LIMITEDIBUCACH 200IBUPROFEN200MGCACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER01/07/2010
957NDA/MAL/HDP/6706CACHET PHARMACEUTICALS PVT LTDASTRA PHARMA (U) LIMITEDCACH-E-WORMMEBENDAZOLE100MG/5MLCACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X30.0 ML BOTTLE01/07/2009
958NDA/MAL/HDP/6705CACHET PHARMACEUTICALS PVT LTDASTRA PHARMA (U) LIMITEDCACHEWORMMEBENDAZOLE100MGCACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIAINDIAORAL SOLID ORDINARY CHEWABLE TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER01/07/2010
959NDA/MAL/HDP/6713CACHET PHARMACEUTICALS PVT LTDASTRA PHARMA (U) LIMITEDCAMETMETOCLOPRAMIDE HYDROCHLORIDE10MGCACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2009
960NDA/MAL/HDP/7357CACHET PHARMACEUTICALS PVT LTDASTRA PHARMA (U) LIMITEDPAMAGIN-C SYRUPCETIRIZINE HYDROCHLORIDE+DEXTROMETHORPHAN HYDROBROMIDE+ACETAMINOPHEN+PHENYLEPHRINE HYDROCHLORIDE+ZINC GLUCONATE+MENTHOL2.5MG+7.5MG+125MG+5MG+7.5MG+2.5MG/5MLCACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIAINDIAORAL LIQUID ORDINARY SYRUPS1.0X60.0 ML BOTTLE31/01/2018
961NDA/MAL/HDP/6712CACHET PHARMACEUTICALS PVT LTDASTRA PHARMA (U) LIMITEDCACID-OOMEPRAZOLE20MGCACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIAINDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE STRIP01/07/2011
962NDA/MAL/HDP/6711CACHET PHARMACEUTICALS PVT LTDASTRA PHARMA (U) LIMITEDCACHPARPARACETAMOL125MG/5MLCACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE01/07/2009
963NDA/MAL/HDP/6703CACHET PHARMACEUTICALS PVT LTDASTRA PHARMA (U) LIMITEDCACHCOLD PLUSPARACETAMOL/ CAFFEINE/ PHENYLEPHRINE/ CHLORPHENIRAMINE500MG/ 30MG/ 5MG/ 2MGCACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X50.0X4.0 TABLET STRIP01/07/2011
964NDA/MAL/HDP/8264CACHET PHARMA PVT LTDASTRA PHARMA (U) LIMITEDEMITINO ORAL SOLUTIONONDANSETRON2MG/5MLCACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIAINDIAORAL LIQUID ORDINARY LIQUIDS1.0X30.0 ML BOTTLE01/07/2017
965NDA/MAL/HDP/6230CACHET PHAMACUITICALS PVT LTDASTRA PHARMA (U) LIMITEDEMITINOONDANSENTRON4MGCACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIAINDIAORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS1.0X10.0 TABLET BLISTER01/07/2016
966NDA/MAL/HDP/6701CACHET PHARMACEUTICALS PVT LTDASTRA PHARMA (U) LIMITEDCACH-ART DSARTEMETHER / LUMEFANTRINE80MG/ 480MGCACHET PHARMACEUTICALS PVT LTD-VILLAGE AND POST THANA BADDI TEHSIL NALAGARH SOLAN DISTRICT HIMACHAL PRADESH 173 205INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X6.0 TABLET BLISTER01/07/2011
967NDA/MAL/HDP/7105CACHET PHARMACEUTICALS PVT LIMITEDASTRA PHARMA (U) LIMITEDTRAMACETAL TABLETSACETAMINOPHEN +TRAMADOL HYDROCHLORIDE325MG+37.5MGCACHET PHARMACEUTICALS PVT LTD-VILLAGE AND POST THANA BADDI TEHSIL NALAGARH SOLAN DISTRICT HIMACHAL PRADESH 173 205INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER01/07/2017
968NDA/MAL/HDP/6709CACHET PHARMACEUTICALS PVT LTDASTRA PHARMA (U) LIMITEDCACHPARPARACETAMOL500MGCACHET PHARMACEUTICALS PVT LTD-VILLAGE AND POST THANA BADDI TEHSIL NALAGARH SOLAN DISTRICT HIMACHAL PRADESH 173 205INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER01/07/2012
969NDA/MAL/HDP/8644CACHET PHARMACEUTICALS PVT LTDASTRA PHARMA (U) LIMITEDLOOBID SUSPENSIONOFLOXACIN + ORNIDAZOLE50MG + 125MG / 5MLCACHET PHARMACEUTICALS PVT LTD-VILLAGE AND POST THANA BADDI TEHSIL NALAGARH SOLAN DISTRICT HIMACHAL PRADESH 173 205INDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X1.0X30.0 ML BOTTLE28/03/2018
970NDA/MAL/HDP/4545CACHET PHAMACUITICALS PVT LTDASTRA PHARMA (U) LIMITEDCACH-ART 20/120ARTEMETHER + LUMEFANTRINE20 MG + 120 MGCACHET PHARMACEUTICALS PVT LTD-VILLAGE AND POST THANA BADDI TEHSIL NALAGARH SOLAN DISTRICT HIMACHAL PRADESH 173 205INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X8.0 TABLET BLISTER01/07/2010
971NDA/MAL/HDP/8665CACHET PHARMACEUTICALS PVT LTDASTRA PHARMA (U) LIMITEDPAMAGIN-CCETIRIZINE HYDROCHLORIDE + DEXTROMETHORPHAN HYDROBROMIDE + ACETAMINOPHEN + PHENYLEPHRINE HYDROCHLORIDE + ZINC GLUCONATE5.0 MG +15 MG + 500 MG + 5 MG + 7.5 MGCACHET PHARMACEUTICALS PVT LTD-VILLAGE AND POST THANA BADDI TEHSIL NALAGARH SOLAN DISTRICT HIMACHAL PRADESH 173 205INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X10.0 TABLET BLISTER28/03/2018
972NDA/MAL/HDP/6244CACHET PHAMACUITICALS PVT LTDASTRA PHARMA (U) LIMITEDCABALINPREGABALIN75MGCACHET PHARMACEUTICALS PVT LTD-VILLAGE AND POST THANA BADDI TEHSIL NALAGARH SOLAN DISTRICT HIMACHAL PRADESH 173 205INDIAORAL SOLID ORDINARY CAPSULES1.0X2.0X12.0 CAPSULE BLISTER01/07/2016
973NDA/MAL/HDP/6737CACHET PHARMACEUTICALS PVT LTDASTRA PHARMA (U) LIMITEDESENVITGLYCERIN/ ZINC SULPHATE/ SODIUM MOLYBDATE/ MANGANESE CHLORIDE/ LYSINE HCL5.0G/ 263.83MG/ 0.4035MG/ 57.66MG/ 612MGCACHET PHARMACEUTICALSPVT.LTD.--415,SHAH NAHAR,WORLI
MUMBAI
INDIAORAL LIQUID ORDINARY SYRUPS1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE01/07/2008
974NDA/MAL/HDP/6138CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDNUCOXIA 60ETORICOXIB60MGCADILA HEALTH CARE LIMITED -PLOT 203-213, KUNDAIM INDUSTRIAL ESTATE, GOA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2016
975NDA/MAL/HDP/6581CADILA HEALTHCARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDZYDALIS 20TADALAFIL20 MGCADILA HEALTH CARE LIMITED-KUNDAIM INDUSTRIAL ESTATE, PONDA, GOA-403401, INDIA.
.
INDIAORAL SOLID ORDINARY TABLETS1.0X4.0 TABLET BLISTER28/08/2019
976NDA/MAL/HDP/4594CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDTINIBA-500 TABLETSTINIDAZOLE500MGCADILA HEALTH CARE LIMITED-KUNDAIM INDUSTRIAL ESTATE, PONDA, GOA-403401, INDIA.
.
INDIAORAL SOLID ORDINARY TABLETS1.0X60.0X4.0 TABLET BLISTER,1.0X25.0X4.0 TABLET BLISTER01/07/1997
977NDA/MAL/HDP/2377CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDR-LOC TABLETSRANITIDINE150MGCADILA HEALTH CARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/1998
978NDA/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 BLISTER01/07/2003
979NDA/MAL/HDP/1681CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDLOSACAR 25LOSARTAN POTASSIUM25MGCADILA HEALTH CARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X7.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER01/07/2003
980NDA/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 BLISTER01/07/2005
981NDA/MAL/HDP/0733CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDZYNACACECLOFENAC100MGCADILA HEALTH CARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2013
982NDA/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 BLISTER01/07/2012
983NDA/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 BLISTER01/07/2012
984NDA/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 STRIP01/07/2004
985NDA/MAL/HDP/3569CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDCARBADAC-200CARBAMAZEPINE200MGCADILA HEALTH CARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA INDIAORAL SOLID ORDINARY TABLETS10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER01/07/1997
986NDA/MAL/HDP/4049CADILA HEALTH CARE LTDABACUS PHARMA (AFRICA) LIMITEDLEVODAY 500LEVOFLOXACIN HEMIHYDRATE500MGCADILA HEALTH CARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X2.0X5.0 TABLET BLISTER,1.0X20.0X5.0 TABLET BLISTER,1.0X6.0X2.0X5.0 TABLET BLISTER01/07/2004
987NDA/MAL/HDP/4169CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDFLUCOZYD-200FLUCONAZOLE200MGCADILA HEALTH CARE LTD-SARKHEJ BAVLA N.H NO. 8A MORAIJA, TAL, SANARD, AHMEDAD 382210, INDIA INDIAORAL SOLID ORDINARY CAPSULES1.0X4.0X7.0 CAPSULE BLISTER,1.0X5.0X4.0 CAPSULE BLISTER01/07/2008
988NDA/MAL/HDP/6357CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDNUCOXIA 90ETORICOXIB90MGCADILA HEALTHCARE LIMITED -KUNDAIM INDUSTRIAL ESTATE,PLOT NO.203-213, KUNDAIM GOA, 403115, INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER28/03/2019
989NDA/MAL/HDP/6358CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDZYROVA 20ROSUVASTATIN CALCIUM20MGCADILA HEALTHCARE LIMITED -KUNDAIM INDUSTRIAL ESTATE,PLOT NO.203-213, KUNDAIM GOA, 403115, INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET STRIP28/03/2019
990NDA/MAL/HDP/6580CADILA HEALTHCARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDOXEPTAL 600XCARBAZEPINE600 MGCADILA HEALTHCARE LIMITED -KUNDAIM INDUSTRIAL ESTATE,PLOT NO.203-213, KUNDAIM GOA, 403115, INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER28/08/2019
991NDA/MAL/HDP/6582CADILA HEALTHCARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDBISOLOL 10BISOPROLOL FUMARATE10 MGCADILA HEALTHCARE LIMITED -KUNDAIM INDUSTRIAL ESTATE,PLOT NO.203-213, KUNDAIM GOA, 403115, INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER28/08/2019
992NDA/MAL/HDP/6912CADILA HEALTHCARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDZYROVA 5ROSUVASTATIN CALCIUM5 MGCADILA HEALTHCARE LIMITED -KUNDAIM INDUSTRIAL ESTATE,PLOT NO.203-213, KUNDAIM GOA, 403115, INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER28/08/2019
993NDA/MAL/HDP/6913CADILA HEALTHCARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDZYROVA 10ROSUVASTATIN CALCIUM10 MGCADILA HEALTHCARE LIMITED -KUNDAIM INDUSTRIAL ESTATE,PLOT NO.203-213, KUNDAIM GOA, 403115, INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER28/08/2019
994NDA/MAL/HDP/7001CADILA HEALTHCARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDDACIHEP 60DACLATASVIR DIHYDROCHLORIDE60 MGCADILA HEALTHCARE LIMITED -KUNDAIM INDUSTRIAL ESTATE,PLOT NO.203-213, KUNDAIM GOA, 403115, INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER28/08/2019
995NDA/MAL/HDP/7086CADILA HEALTHCARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDZYLIN 75PREGABALIN75MGCADILA HEALTHCARE LIMITED -KUNDAIM INDUSTRIAL ESTATE,PLOT NO.203-213, KUNDAIM GOA, 403115, INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X3.0X10.0 CAPSULE BLISTER28/03/2019
996NDA/MAL/HDP/7484CADILA HEALTHCARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDATORVA AM 10/20AMLODIPINE BESYLATE + ATORVASTATIN CALCIUM10MG + 20MGCADILA HEALTHCARE LIMITED -KUNDAIM INDUSTRIAL ESTATE,PLOT NO.203-213, KUNDAIM GOA, 403115, INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER27/11/2019
997NDA/MAL/HDP/7485CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDATORVA AM 5/10AMLODIPINE BESYLATE + ATORVASTATIN CALCIUM5MG + 10MGCADILA HEALTHCARE LIMITED -KUNDAIM INDUSTRIAL ESTATE,PLOT NO.203-213, KUNDAIM GOA, 403115, INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER27/11/2019
998NDA/MAL/HDP/7486CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDATORVA AM 5/20AMLODIPINE BESYLATE + ATORVASTATIN CALCIUM5MG + 20MGCADILA HEALTHCARE LIMITED -KUNDAIM INDUSTRIAL ESTATE,PLOT NO.203-213, KUNDAIM GOA, 403115, INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET CARTON27/11/2019
999NDA/MAL/HDP/0245CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDEUGLIM 4GLIMEPIRIDE4MGCADILA HEALTHCARE LIMITED -KUNDAIM INDUSTRIAL ESTATE,PLOT NO.203-213, KUNDAIM GOA, 403115, INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2014
1000NDA/MAL/HDP/0756CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDTOLFREE 100TOLPERISONE100MGCADILA HEALTHCARE LIMITED -KUNDAIM INDUSTRIAL ESTATE,PLOT NO.203-213, KUNDAIM GOA, 403115, INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2014
1001NDA/MAL/HDP/0757CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDTOLFREE 150TOLPERISONE150MGCADILA HEALTHCARE LIMITED -KUNDAIM INDUSTRIAL ESTATE,PLOT NO.203-213, KUNDAIM GOA, 403115, INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2014
1002NDA/MAL/HDP/3739CADILA HEALTH CARE LTDABACUS PHARMA (AFRICA) LIMITEDALDRENALENDRONATE70MGCADILA HEALTHCARE LIMITED -KUNDAIM INDUSTRIAL ESTATE,PLOT NO.203-213, KUNDAIM GOA, 403115, INDIAORAL SOLID ORDINARY TABLETS1.0X4.0 TABLET BLISTER01/07/2011
1003NDA/MAL/HDP/4067CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDCATENOL-50 TABLETSATENOLOL50MGCADILA HEALTHCARE LIMITED -KUNDAIM INDUSTRIAL ESTATE,PLOT NO.203-213, KUNDAIM GOA, 403115, INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER01/07/1997
1004NDA/MAL/HDP/5405CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDOLANDUS 10OLANZAPINE10MGCADILA HEALTHCARE LIMITED -KUNDAIM INDUSTRIAL ESTATE,PLOT NO.203-213, KUNDAIM GOA, 403115, INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2005
1005NDA/MAL/HDP/6136CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDNUCOXIA 120ETORICOXIB120MGCADILA HEALTHCARE LIMITED -PLOT 203-213, KUNDAIM INDUSTRIAL ESTATE, GOA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2016
1006NDA/MAL/HDP/5075CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDDEXONA TABLETSDEXAMETHASONE0.5MGCADILA HEALTHCARE LIMITED SARKHEJ-SARKHEJ-BAVLA N.H NO.8A, N.H NO.8A, INDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET STRIP01/07/1997
1007NDA/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 BLISTER01/07/1997
1008NDA/MAL/HDP/2220CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDAMLODAC 5AMLODIPINE BESYLATE5MGCADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA INDIAORAL SOLID ORDINARY TABLETS10.0X10.0 TABLET STRIP,1.0X3.0X10.0 TABLET BLISTER01/07/2003
1009NDA/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 BLISTER01/07/2004
1010NDA/MAL/HDP/0400CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDIBSOL 1.2MESALAMINE DELAYED RELEASE1.2GMCADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA INDIAORAL SOLID RETARD FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2013
1011NDA/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 BLISTER01/07/2001
1012NDA/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 BLISTER01/07/2005
1013NDA/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 BLISTER01/07/1997
1014NDA/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 STRIP01/07/1997
1015NDA/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 BLISTER01/07/2004
1016NDA/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 BLISTER01/07/2001
1017NDA/MAL/HDP/3743CADILA HEALTH CARE LTDABACUS PHARMA (AFRICA) LIMITEDCARVIL 3.125CARVEDILOL3.125 MGCADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS10.0X10.0 TABLET BLISTER01/07/2006
1018NDA/MAL/HDP/4132CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDZYCEL 200CELECOXIB200MGCADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER01/07/2001
1019NDA/MAL/HDP/4170CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDTRAMAZACTRAMADOL HYDROCHLORIDE50MGCADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER01/07/2000
1020NDA/MAL/HDP/4364CADILA HEALTHCARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDVOMIZ OD 8ONDANSETRON HYDROCHLORIDE DIHYDRATE8MGCADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2016
1021NDA/MAL/HDP/5148CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDBETANASE TABLETSGLIBENCLAMIDE5MGCADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X5.0X3.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X2.0X50.0 TABLET BLISTER01/07/1997
1022NDA/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 BLISTER01/07/1997
1023NDA/MAL/HDP/2827CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDR-LOCRANITIDINE25MG/MLCADILA HEALTHCARE LTD SARKHEJ-BAVLA NH NO.8A MORAIYA TAL SANAND DISTRICT AHMEDABAD 382210INDIAPARENTERAL ORDINARY AMPOULES1.0X5.0X2.0 ML AMPOULE01/07/2010
1024NDA/MAL/HDP/0934CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDODIMONT 4MONTELUKAST4MGCADILA HEALTHCARE LTD SARKHEJ-BAVLA NH NO.8A MORAIYA TAL SANAND DISTRICT AHMEDABAD 382210INDIAORAL SOLID ORDINARY CHEWABLE COATED TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2011
1025NDA/MAL/HDP/8233CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDCOLSTIMFILGRASTIM300µG/MLCADILA HEALTHCARE LTD.--PLOT SURVEY NO. 23, 25/P, 37, 40/P, 42 TO 47 SARKHEJ BAVLA N.H NO.8A OPP.RAMDEV MASALA CHANGODAR TAL. SANAND DIST AHMEDABAD 382213 INDIAPARENTERAL ORDINARY PRE-FILLED SYRINGES1.0X1.0 ML PRE- FILLED SYRINGE01/07/2017
1026NDA/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 BLISTER01/07/2003
1027NDA/MAL/HDP/0630CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDNEO LORIDINDESLORATADINE5MGCADILA HEALTHCARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO.203-213, KUNDAIM GOA, 403115, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER01/07/2011
1028NDA/MAL/HDP/0823CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDTRAP TABLETSTRAMADOL HCL + PARACETAMOL37.5MG+325MGCADILA HEALTHCARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO.203-213, KUNDAIM GOA, 403115, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2013
1029NDA/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 BLISTER01/07/2001
1030NDA/MAL/HDP/3663CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDAMLODAC 10AMLODIPINE BESYLATE10MGCADILA HEALTHCARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO.203-213, KUNDAIM GOA, 403115, INDIA INDIAORAL SOLID ORDINARY TABLETS10.0X10.0 TABLET STRIP,1.0X3.0X10.0 TABLET BLISTER01/07/2003
1031NDA/MAL/HDP/3704CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDPENEGRA 100SILDENAFIL100MGCADILA 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 BLISTER01/07/2002
1032NDA/MAL/HDP/4621CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDCARVIL 6.25CARVEDILOL6.25MGCADILA HEALTHCARE LTD--PLOT 203-213, KUNDAIM INDUSTRIAL ESTATE, GOA 403401 INDIAORAL SOLID ORDINARY TABLETS10.0X10.0 TABLET BLISTER01/07/2006
1033NDA/MAL/HDP/2187CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDVOMIZONDANSETRON4MG/2MLCADILA HEALTHCARE LTD---SARKHEJ-PLOT 417,419,420, SARKHEJ-BAVLA NH NO.8A,VILLAGE: MORAIYA TAL: SANAND DISTRICT AHMEDABAD 382210 INDIAPARENTERAL ORDINARY AMPOULES1.0X5.0X2.0 ML AMPOULE,1.0X5.0X4.0 ML AMPOULE01/07/2005
1034NDA/MAL/HDP/1519CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDFORMONIDE 400BUDESONIDE + FORMOTEROL FUMARATE120 METERED DOSES (400MCG/6MCG)CADILA HEALTHCARE LTD---SARKHEJ-PLOT 417,419,420, SARKHEJ-BAVLA NH NO.8A,VILLAGE: MORAIYA TAL: SANAND DISTRICT AHMEDABAD 382210 INDIALUNG ADMINISTRATION METERED-DOSE INHALER1.0X1.0 CANNISTER CARTON01/07/2007
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 CANNISTER01/07/2007
1036NDA/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 BLISTER01/07/2011
1037NDA/MAL/HDP/0700CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDVAXIRAB NINACTIVATED RABIES VIRUS(PITMAN MOORE STRAIN)>2.5 I.UCADILA HEALTHCARE LTD---SARKHEJ-PLOT 417,419,420, SARKHEJ-BAVLA NH NO.8A,VILLAGE: MORAIYA TAL: SANAND DISTRICT AHMEDABAD 382210 INDIAPARENTERAL ORDINARY VIALS1.0X1.0 ML VIAL + 1ML AMPOULE OF WFI(1 DOSE VIAL)01/07/2015
1038NDA/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 CARTON01/07/2007
1039NDA/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 AMPOULE01/07/2001
1040NDA/MAL/HDP/5051CADILA HEALTHCARE LIMITED SARKHEJABACUS PHARMA (AFRICA) LIMITEDDERIHALERSALBUTAMOL100CMG/DOSECADILA 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 INHALER1.0X200.0 METERED DOSE CANNISTER01/07/2005
1041NDA/MAL/HDP/2751CADILA PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.FLUDAC CAPSULESFLUOXETINE HCL20MGCADILA PHARMACEUTICALS LIMITED-1389 DHOLKA 387810 DISTRCT AHMEDABAD GUJARAT STATEINDIAORAL SOLID ORDINARY CAPSULES1.0X20.0 CAPSULE BLISTER01/07/1997
1042NDA/MAL/HDP/6843CADILA PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.FYTOBACTCEFOPERAZONE + SULBACTAM0.5 G + 0.5 GCADILA PHARMACEUTICALS LIMITED-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0 G VIAL01/07/2009
1043NDA/MAL/HDP/6845CADILA PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.FYTOBACT 2GSULBACTAM SODIUM + CEFOPERAZONE SODIUM1G + 1GCADILA PHARMACEUTICALS LIMITED-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA INDIAPARENTERAL ORDINARY DRY VIALS1.0X2.0 G VIAL01/07/2017
1044NDA/MAL/HDP/8743CADILA PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.ISONIAZIDISONIAZID300 MGCADILA PHARMACEUTICALS LIMITED-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X24.0X28.0 TABLET BLISTER01/07/2010
1045NDA/MAL/HDP/7342CADILA PHARMACEUTICALS LIMITEDESCORTS PHARMACEUTICALS LIMITEDZEALARGYRUPATADINE FUMERATE10 MGCADILA PHARMACEUTICALS LIMITED-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2017
1046NDA/MAL/HDP/8312CADILA PHARMACEUTICALS LIMITEDESCORTS PHARMACEUTICALS LIMITEDTRICORT 40TRIAMCINOLONE ACETONIDE40MG/MLCADILA PHARMACEUTICALS LIMITED-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA INDIAPARENTERAL ORDINARY VIALS1.0X1.0 ML VIAL29/11/2017
1047NDA/MAL/HDP/1635CADILA PHARMACEUTICALS LIMITEDESCORTS PHARMACEUTICALS LIMITEDORITAXIM 1000MG INJECTIONCEFOTAXIME SODIUM1GMCADILA PHARMACEUTICALS LIMITED-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA INDIAPARENTERAL ORDINARY VIALS1.0X1.0 G VIAL01/07/1997
1048NDA/MAL/HDP/2093CADILA PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.TRIGAN-D TABLETPARACETAMOL + DICYCLOMINE500MG + 20MGCADILA PHARMACEUTICALS LIMITED-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA INDIAORAL SOLID ORDINARY TABLETS10.0X10.0 TABLET STRIP01/07/1999
1049NDA/MAL/HDP/2071CADILA PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.CEFAMOR DRY SYRUPCEFALEXIN125MG/5MLCADILA PHARMACEUTICALS LIMITED-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE01/07/2000
1050NDA/MAL/HDP/1445CADILA PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.AXONE 1000CEFTRIAXONE SODIUM1000MGCADILA PHARMACEUTICALS LIMITED-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA INDIAPARENTERAL ORDINARY DRY VIALS1.0X1000.0 MG VIAL01/07/2003
1051NDA/MAL/HDP/2765CADILA PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.HAEM FFOLICACID+ VITAMIN B12+IRON AMMONIUM CITRATE1MG+5MCG+200MG/15MLCADILA PHARMACEUTICALS LIMITED-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA INDIAORAL LIQUID ORDINARY SYRUPS1.0X200.0 ML BOTTLE01/07/2004
1052NDA/MAL/HDP/1941CADILA PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.RABELOC IVRABEPRAZOLE20MG/VIALCADILA PHARMACEUTICALS LIMITED-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA INDIAPARENTERAL ORDINARY VIALS1.0X5.0 ML VIAL01/07/2005
1053NDA/MAL/HDP/0984CADILA PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.JOVAN T20TADALAFIL20MGCADILA PHARMACEUTICALS LIMITED-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER01/07/2013
1054NDA/MAL/HDP/0673CADILA PHARMACEUTICALS LIMITEDESCORTS PHARMACEUTICALS LIMITEDONSETT 8ONDANSETRON8MGCADILA PHARMACEUTICALS LIMITED-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2013
1055NDA/MAL/HDP/0676CADILA PHARMACEUTICALS LIMITEDESCORTS PHARMACEUTICALS LIMITEDONSETT 4ONDANSETRON4MGCADILA PHARMACEUTICALS LIMITED-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2013
1056NDA/MAL/HDP/0587CADILA PHARMACEUTICALS LIMITEDESCORTS PHARMACEUTICALS LIMITEDCADIGRELCLOPIDOGREL75MGCADILA PHARMACEUTICALS LIMITED-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2013
1057NDA/MAL/HDP/0668CADILA PHARMACEUTICALS LIMITEDESCORTS PHARMACEUTICALS LIMITEDTELI 40TELMISARTAN40MGCADILA PHARMACEUTICALS LIMITED-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2013
1058NDA/MAL/HDP/0988CADILA PHARMACEUTICALS LIMITEDESCORTS PHARMACEUTICALS LIMITEDCADITOR 20ATORVASTATIN20MGCADILA PHARMACEUTICALS LIMITED-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2013
1059NDA/MAL/HDP/0586CADILA PHARMACEUTICALS LIMITEDESCORTS PHARMACEUTICALS LIMITEDONSETTONDANSETRON2MG/MLCADILA PHARMACEUTICALS LIMITED-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA INDIAPARENTERAL ORDINARY AMPOULES1.0X5.0X2.0 ML AMPOULE,1.0X5.0X4.0 ML AMPOULE01/07/2013
1060NDA/MAL/HDP/3571CADILA PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.CADIPHEN EXPECTORANTCHLORPHENIRAMINE/GUAIFENESIN/AMMONIUM CHLORIDE2MG//80MG/100MGCADILA PHARMACEUTICALS LIMITED-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA INDIAORAL LIQUID ORDINARY SYRUPS1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE01/07/1997
1061NDA/MAL/HDP/3779CADILA PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.LOSIUM 50LOSARTAN POTASSIUM50MGCADILA PHARMACEUTICALS LIMITED-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X2.0X1.0X14.0 TABLET BLISTER01/07/2011
1062NDA/MAL/HDP/8641CADILA PHARMACEUTICALS LIMITEDESCORTS PHARMACEUTICALS LIMITEDTELI HTELMISARTAN + HYDROCHLOROTHIAZIDE40MG + 12.5MGCADILA PHARMACEUTICALS LIMITED-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA INDIAORAL SOLID ORDINARY LAYERED TABLETS1.0X3.0X10.0 TABLET BLISTER28/03/2018
1063NDA/MAL/HDP/4015CADILA PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.TAMBAC 50CEFPODOXIME PROXETIL50MG/5MLCADILA PHARMACEUTICALS LIMITED-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X60.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE01/07/2005
1064NDA/MAL/HDP/4987CADILA PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.PYRAZINAMIDEPYRAZINAMIDE400 MGCADILA PHARMACEUTICALS LIMITED-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X24.0X28.0 TABLET BLISTER01/07/2009
1065NDA/MAL/HDP/5233CADILA PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.ENVAS 10 MG TABLETSENALAPRIL10MGCADILA PHARMACEUTICALS LIMITED-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/1997
1066NDA/MAL/HDP/5234CADILA PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.ENVAS 5MG TABLETSENALAPRIL MALEATE5MGCADILA PHARMACEUTICALS LIMITED-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/1997
1067NDA/MAL/HDP/5300CADILA PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.DOLACKETOROLAC TROMETHAMINE30MGCADILA PHARMACEUTICALS LIMITED-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA INDIAPARENTERAL ORDINARY AMPOULES1.0X10.0X1.0 ML AMPOULE01/07/2015
1068NDA/MAL/HDP/5619CADILA PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.RABELOC 20RABEPRAZOLE SODIUM20MGCADILA PHARMACEUTICALS LIMITED-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X1.0X10.0 TABLET STRIP01/07/2006
1069NDA/MAL/HDP/9169CADILA PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.PROCTICADLACTITOL MONOHYDRATE10 GM/15MLCADILA PHARMACEUTICALS LIMITED-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA INDIAORAL LIQUID ORDINARY LIQUIDS1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE27/11/2019
1070NDA/MAL/HDP/5436CADILA PHARMACEUTICALS LIMITEDESCORTS PHARMACEUTICALS LIMITEDCEFICAD 1000CEFEPIME HCL1000MGCADILA PHARMACEUTICALS LTD. .-1389, TRASAD ROAD, DHOLKA-387810, GUJARAT STATE INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0X1000.0 MG VIAL01/07/2009
1071NDA/MAL/HDP/2967CADILA PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.HAEM-FFERROUS FUMARATE200MGCADILA PHARMACEUTICALS LTD.-1389, TRASAD ROAD, DHOLKA 387810 DISTRICT AHMEDABAD GUJARAT STATE INDIAORAL SOLID ORDINARY CAPSULES1.0X30.0 CAPSULE BOTTLE01/07/2003
1072NDA/MAL/HDP/3694CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDLORIDIN RAPITABLORATADINE10MGCADILANHEALTH CARE LTD ,,;-KUNDAIN INDUSTRIAL ESTATE PONDA GOA INDIAORAL SOLID ORDINARY SOLUBLE TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2002
1073NDA/MAL/HDP/6716NOVARTIS PHARMA SERVICES INCSURGIPHARM (U) LIMITEDCATAFLAM 50DICLOFENAC POTASSIUM50MGCATALENT GERMANY EBERBACH GMBH..-GAMMELS BACHERSTRASSE2
GERMANYORAL SOLID ORDINARY OTHER CAPSULES1.0X10.0 CAPSULE BLISTER,1.0X20.0 CAPSULE BLISTER01/07/2016
1074NDA/MAL/HDP/0576GLAXO SMITH KLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDDUODARTDUTASTERIDE + TAMSULOSIN0.5MG + 0.4MGCATALENT GERMANY SCHONDORF GMBH -STEINBEISSTRASSE 1-2, 73614 SCHORNDORF, GERMANY GERMANYORAL SOLID ORDINARY CAPSULES1.0X30.0 CAPSULE CONTAINER01/07/2015
1075NDA/MAL/HDP/6359CCL PHARMACEUTICALS (PVT.)LTD.HARLEYS UGANDA LIMITEDNEO-KLAR 250MGCLARITHROMYCIN250MGCCL PHARMACEUTICALS (PVT) LTD -62 INDUSTRIAL ESTATE, KOT LAKHPAT, LAHORE-54770, PAKISTAN PAKISTANORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X10.0 TABLET BLISTER28/03/2019
1076NDA/MAL/HDP/6696CCL PHARMACEUTICALS (PVT.)LTD.HARLEYS UGANDA LIMITEDGABLINPREGABALIN75MGCCL PHARMACEUTICALS (PVT) LTD -62 INDUSTRIAL ESTATE, KOT LAKHPAT, LAHORE-54770, PAKISTAN PAKISTANORAL SOLID ORDINARY OTHER CAPSULES1.0X2.0X7.0 CAPSULE BLISTER28/03/2019
1077NDA/MAL/HDP/7477CHEPLAPHARM ARZNEIMITTEL GMBHLABOREX UGANDA LIMITEDROHYPNOLFLUNITRAZEPAM1 MGCENEXI S.A.S-52, RUE MARCEL ET JACQUES GAUCHER 94120 FONTENAY-SOUS-BOIS- FRANCE FRANCEORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER28/03/2019
1078NDA/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 TUBE01/07/2000
1079NDA/MAL/HDP/3574CENTAUR PHARMACEUTICALS PRIVATE LIMITEDGITTOES PHARMACEUTICALS LIMITEDMETOZ 2.5 TABLETMETOLAZONE TABLETS USP2.5MGCENTAUR PHARMA PVT.LIMITED-PLANT I-PLOT3,TIVIM INDUSTRIAL ESTATE,KARASWADA,MAPUSA GOA INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER01/07/2007
1080NDA/MAL/HDP/3581CENTAUR PHARMACEUTICALS PRIVATE LIMITEDGITTOES PHARMACEUTICALS LIMITEDMETOZ 5METOLAZONE5MGCENTAUR PHARMA PVT.LTD-PLANT I-PLOT 3,TIVIM INDUSTRIAL ESTATE,KARASWADA,MAPUSA GOA INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER01/07/2007
1081NDA/MAL/HDP/2940CENTAUR PHARMACEUTICALS PRIVATE LIMITEDGITTOES PHARMACEUTICALS LIMITEDBENZOX 5 GELBENZOYL PEROXIDE5%W/WCENTAUR PHARMACEUTICALS LTD- PLOT NO. 39 TIVIN IN
INDIATOPICAL EXTERNAL OTHER GELS/SOLS1.0X2.0 G TUBE01/07/2005
1082NDA/MAL/HDP/2018CENTAUR PHARMACEUTICALS LTDGITTOES PHARMACEUTICALS LIMITEDORAXIN SYRUPCYPROHEPTADINE+TRICHOLINE CITRATE2MG+275MGCENTAUR PHARMACEUTICALS LTD,--KARASWADA MAPUSA GOA INDIAORAL LIQUID ORDINARY SYRUPS1.0X200.0 ML BOTTLE,1.0X100.0 ML BOTTLE01/07/1997
1083NDA/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 BLISTER01/07/1997
1084NDA/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 BLISTER01/07/2004
1085NDA/MAL/HDP/3754CENTAUR PHARMACEUTICALS PRIVATE LIMITEDGITTOES PHARMACEUTICALS LIMITEDSINAREST PD NASAL DROPSOXYMETAZOLINE HYDROCHLORIDE0.025%W/VCENTAUR PHARMACEUTICALS LTD-PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIAINDIANASAL TOPICAL DROPS1.0X10.0 ML BOTTLE01/07/2006
1086NDA/MAL/HDP/4182CENTAUR PHARMACEUTICALS LTDGITTOES PHARMACEUTICALS LIMITEDSINAREST- FORTEMULTI INGREDIENTMULTI INGREDIENTCENTAUR PHARMACEUTICALS LTD-PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X50.0X4.0 TABLET STRIP01/07/2007
1087NDA/MAL/HDP/5122CENTAUR PHARMACEUTICALS LTDGITTOES PHARMACEUTICALS LIMITEDKOFAREST SYRUPSALBUTAMOL SULPHATE/AMBROXOL SULPHATE/GUAFENESIN/MENTHOL2MG+30MG+100MG+5MG/10MLCENTAUR PHARMACEUTICALS LTD-PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIAINDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE01/07/2007
1088NDA/MAL/HDP/4118CENTAUR PHARMACEUTICALS LTDGITTOES PHARMACEUTICALS LIMITEDOCUREST-AHPHENYLEPHRINE HYDROCHLORIDE+NAPHAZOLINE HYDROCHLORIDE+CHLORPHRENIRAMINE MALEATE+MENTHOL+CAMPHOR0.12%+0.05%+0.1%+0.005%+0.01%CENTAUR PHARMACEUTICALS PRIVATE LIMITED-PLOT NO.3,TIVIM INDUSTRIAL ESTATE KARASWADA MUPUSA-GOA 403 526 INDIA INDIAOPHTHALMIC DROPS1.0X10.0 ML VIAL01/07/2005
1089NDA/MAL/HDP/3357CENTAUR PHAMACUITICALSGITTOES PHARMACEUTICALS LIMITEDESOREST 20ESOMEPRAZOLE20MGCENTAUR PHARMACEUTICALS PVT L.T.D.-CENTAUR HOUSE NEARINDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2008
1090NDA/MAL/HDP/3364CENTAUR PHAMACUITICALSGITTOES PHARMACEUTICALS LIMITEDESOREST 40ESOMEPRAZOLE40MGCENTAUR PHARMACEUTICALS PVT L.T.D.-CENTAUR HOUSE NEARINDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2008
1091NDA/MAL/HDP/1264CENTAUR PHARMACEUTICALS PRIVATE LIMITEDGITTOES PHARMACEUTICALS LIMITEDOCUCYCLINE EYE OINTMENTTETRACYCLINE HYDROCHLORIDE1%W/WCENTAUR PHARMACEUTICALS PVT LTD --PLANT II PLOT 39-41 TIVIM INDUSTRIAL ESTATE KARASWADA MAPUSA GOA 403 526INDIAOPHTHALMIC OINTMENTS1.0X5.0 G TUBE,1.0X3.5 G TUBE01/07/2000
1092NDA/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 TUBE01/07/2001
1093NDA/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 TUBE01/07/2005
1094NDA/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 TUBE01/07/2005
1095NDA/MAL/HDP/2141CENTAUR PHARMACEUTICALS PRIVATE LIMITEDGITTOES PHARMACEUTICALS LIMITEDINFLAZONEMULTIINGREDIENTN/ACENTAUR PHARMACEUTICALS PVT LTD --PLANT II PLOT 39-41 TIVIM INDUSTRIAL ESTATE KARASWADA MAPUSA GOA 403 526INDIATOPICAL EXTERNAL OINTMENTS1.0X30.0 G TUBE01/07/2005
1096NDA/MAL/HDP/4867CENTAUR PHARMACEUTICALS PVT LTDGITTOES PHARMACEUTICALS LIMITEDMICONA ORAL GELMICONAZOLE20MGCENTAUR PHARMACEUTICALS PVT LTD --PLANT II PLOT 39-41 TIVIM INDUSTRIAL ESTATE KARASWADA MAPUSA GOA 403 526INDIAORAL TOPICAL GELS AND SOLS1.0X40.0 G TUBE,1.0X20.0 G TUBE01/07/2003
1097NDA/MAL/HDP/5228CENTAUR PHARMACEUTICALS PVT LTDGITTOES PHARMACEUTICALS LIMITEDDICLOGENTADICLOFENAC SODIUM+GENTAMICIN SULPHATE1MG/ML+3MG/MLCENTAUR PHARMACEUTICALS PVT LTD --PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIAINDIAOPHTHALMIC DROPS1.0X5.0 ML BOTTLE01/07/2009
1098NDA/MAL/HDP/5415CENTAUR PHARMACEUTICALS PVT LTDGITTOES PHARMACEUTICALS LIMITEDSINARESTOXYMETAZOLINE0.05%W/VCENTAUR PHARMACEUTICALS PVT LTD --PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIAINDIANASAL TOPICAL DROPS1.0X10.0 ML VIAL01/07/2009
1099NDA/MAL/HDP/1589CENTAUR PHARMACEUTICALS PVT LTDGITTOES PHARMACEUTICALS LIMITEDCENTACID SUSPENSIONMAGNESIUM HYDROXIDE + ALUMINIUM HYDROXIDE+SIMETHICONE40MG+200MG+250MG/5MLCENTAUR PHARMACEUTICALS PVT LTD-PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE,1.0X170.0 ML BOTTLE01/07/1997
1100NDA/MAL/HDP/1591CENTAUR PHARMACEUTICALS LTDGITTOES PHARMACEUTICALS LIMITEDCENTIPAR ELIXIRPIPERAZINE CITRATE750ML/5MLCENTAUR PHARMACEUTICALS PVT LTD-PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIAINDIAORAL LIQUID ORDINARY LIQUIDS1.0X30.0 ML BOTTLE01/07/1997
1101NDA/MAL/HDP/4023CENTAUR PHARMACEUTICALS LTDGITTOES PHARMACEUTICALS LIMITEDSINAREST LINCTUSCHLORPHENIRAMINE+DEXTROMETHORPHAN+METHANOL2MG+10MG+1.5MGCENTAUR PHARMACEUTICALS PVT LTD-PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIAINDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE01/07/1997
1102NDA/MAL/HDP/4101CENTAUR PHARMACEUTICALS PVT LTDGITTOES PHARMACEUTICALS LIMITEDAMLOTRUST 5AMLODIPINE5MGCENTAUR PHARMACEUTICALS PVT LTD-PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER01/07/2015
1103NDA/MAL/HDP/4082SANOFI AVENTISSURGIPHARM (U) LIMITEDNO-SPA FORTEDROTAVERINE HCL80MGCHINOIN PHARMACEITCAULS AND CHEMICAL WORKS CO. LTD-H10-45 BUDAPEST TOU HUNGARY.HUNGARYORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER01/07/2010
1104NDA/MAL/HDP/2569SANOFI AVENTISSURGIPHARM (U) LIMITEDNO-SPADROTAVERINE HYDROCHLORIDE40MG/2MLCHINOIN PHARMACEUTICAL AND CHEMICAL WORKS PRIVATE CO. LTD CSANYIKVOLGY SITE-CSANYIKVOLGY, P.O.BOX 565.3510, MISKOLC, HUGARY HUNGARYPARENTERAL ORDINARY AMPOULES1.0X2.0 ML AMPOULE01/07/1998
1105NDA/MAL/HDP/3977CHINOIN PHARMACEUTICALS AND CHEMICAL WORKS, CO. LTDSURGIPHARM (U) LIMITEDNO-SPA 40MGDROTAVERINE HYDROCHLORIDE40MGCHINOIN PHARMACEUTICAL AND CHEMICAL WORKS PRIVATE CO.LTD-H-2112, VERESEGYHAZ, LEVAI U.5.HUNGARY HUNGARYORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X2.0X10.0 TABLET BLISTER01/07/1998
1106NDA/MAL/HDP/2507CIPLA LTDQUALITY CHEMICALS LTD - HUMANEXERMET 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 BLISTER01/07/2007
1107NDA/MAL/HDP/8826CIPLA LTD.QUALITY CHEMICALS LTD - HUMANABACAVIR SULFATE AND LAMIVUDINE TABLETS FOR ORAL SUSPENSION 120/60 MGABACAVIR SULFATE + LAMIVUDINE120MG + 60MGCIPLA LIMITED -PLOT NO A – 33, A – 2 (UNIT – I),
MIDC PATALGANGA,
DISTRICT RAIGAD, 410 220
MAHARASHTRA, INDIA
INDIAORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS1.0X1.0X60.0 TABLET BOTTLE30/05/2018
1108NDA/MAL/HDP/3191CIPLA LTDQUALITY CHEMICALS LTD - HUMANERECTO -100SILDENAFIL CITRATE100 MGCIPLA LIMITED PUNE-MIDC, KURKUMBH DISTRICT PUNE 413802 INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0 TABLET BLISTER01/07/2014
1109NDA/MAL/HDP/3193CIPLA LTDQUALITY CHEMICALS LTD - HUMANERECTO- 50SILDENAFIL CITRATE50MGCIPLA LIMITED PUNE-MIDC, KURKUMBH DISTRICT PUNE 413802 INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0 TABLET BLISTER01/07/2005
1110NDA/MAL/HDP/3220CIPLA LTDQUALITY CHEMICALS LTD - HUMANPYLO 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)01/07/2005
1111NDA/MAL/HDP/6312CIPLA LTDQUALITY CHEMICALS LTD - HUMANDARUNAVIR (AS ETHANOLATE) TABLETS 800 MGDARUNAVIR ETHANOLATE800MGCIPLA LIMITED,-PLOT NO A–42 (UNIT–II ) MIDC PATALGANGA,
DISTRICT RAIGAD, 410 220 MAHARASHTRA,INDIA
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X30.0 TABLET CONTAINER07/11/2018
1112NDA/MAL/HDP/8690CIPLA LTDQUALITY CHEMICALS LTD - HUMANARTESUNATE SUPPOSITORIES 100MGARTESUNATE100MGCIPLA LIMITED.,-PLOT NO.D-7 MIDC INDUSTRIAL AREA,
KURKUMBH,DIST:PUNE 413802,INDIA
INDIARECTAL SYSTEMIC SUPPOSITORIES1.0X1.0X2.0 BLISTER CARTON26/09/2018
1113NDA/MAL/HDP/2193CIPLA LTD..QUALITY CHEMICALS LTD - HUMANCIPLOX-500CIPROFLOXACIN500MGCIPLA LIMITED.-PLOT NO. L-139, S-103 & M-62, VERNA INDUSTRIAL ESTATE, VERNA SALCETTE, GOA, PIN 403722 INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CONTAINER01/07/2007
1114NDA/MAL/HDP/8933CIPLA LTDQUALITY CHEMICALS LTD - HUMANQ-TIBSULFAMETHOXAZOLE + TRIMETHOPRIM + ISONIAZID + PYRIDOXINE HYDROCHLORIDE800MG + 160MG + 300MG +25MGCIPLA LIMITED>-A-33, A-37/2/2 & A-2, M.I.D.C, PATALANGA 410 220, DISTRICT RAIGAD, M.S, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X1.0X30.0 TABLET BOTTLE25/07/2018
1115NDA/MAL/HDP/1525CIPLA LIMITED.QUALITY CHEMICALS LTD - HUMANBENDEXALBENDAZOLE20MG/5MLCIPLA LTD ,,-PLOT NO. 9,10,15 INDORE SPECIAL ECONOMIC ZONE PHASE II PITHAMPUR DISTRICT DHAR MADHYA PRADESH PIN. 454775 INDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X10.0 ML BOTTLE01/07/2007
1116NDA/MAL/HDP/7457CIPLA LTD.QUALITY CHEMICALS LTD - HUMANCIPLADONPARACETAMOL EFFERVESCENT1000MGCIPLA LTD ,,-PLOT NO. 9,10,15 INDORE SPECIAL ECONOMIC ZONE PHASE II PITHAMPUR DISTRICT DHAR MADHYA PRADESH PIN. 454775 INDIAORAL SOLID ORDINARY EFFERVESCENT TABLETS1.0X6.0X4.0 TABLET BLISTER28/11/2019
1117NDA/MAL/HDP/7008CIPLA LTD.QUALITY CHEMICALS LTD - HUMANDARUNAVIR TABLETSDARUNAVIR ETHANOLATE400 MGCIPLA LTD ,.-PLOT NO. A-33, A-2 (UNIT 1), A42 (UNIT II), MIDC PATALGANGA, DISTRICT-RAIGAD MAHARASHTRA, 410220 INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X60.0 TABLET CONTAINER28/08/2019
1118NDA/MAL/HDP/7009CIPLA LTD.QUALITY CHEMICALS LTD - HUMANDARUNAVIR TABLETSDARUNAVIR ETHANOLATE600 MGCIPLA LTD ,.-PLOT NO. A-33, A-2 (UNIT 1), A42 (UNIT II), MIDC PATALGANGA, DISTRICT-RAIGAD MAHARASHTRA, 410220 INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X60.0 TABLET CONTAINER28/08/2019
1119NDA/MAL/HDP/7427CIPLA LTD.QUALITY CHEMICALS LTD - HUMANEFAVIRENZ + LAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATEEFAVIRENZ + LAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE400MG + 300MG + 300MGCIPLA LTD ,.-PLOT NO. A-33, A-2 (UNIT 1), A42 (UNIT II), MIDC PATALGANGA, DISTRICT-RAIGAD MAHARASHTRA, 410220 INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET BOTTLE28/11/2019
1120NDA/MAL/HDP/1777CIPLA LTD.QUALITY CHEMICALS LTD - HUMANNUZAC 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 BLISTER01/07/2003
1121NDA/MAL/HDP/6183CIPLA LTD..QUALITY CHEMICALS LTD - HUMANPRAZIQUANTEL TABLETSPRAZIQUANTEL600MGCIPLA LTD .-352 KUNDAIM INDL. ESTATE KUNDAIM GOA 403 115INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X100.0 TABLET BOTTLE,1.0X500.0 TABLET BOTTLE01/07/2016
1122NDA/MAL/HDP/4880CIPLA LTDQUALITY CHEMICALS LTD - HUMANMISOPROST 200MISOPROSTOL200MCGCIPLA LTD .-CIPLA GOA UNIT 8 L-147 TO L-147/1 L-147-3 TO L-138 VERNA INDUSTRIAL ESTATE VERNA GOAINDIAORAL SOLID ORDINARY TABLETS1.0X1.0X4.0 TABLET BLISTER,1.0X7.0X4.0 TABLET BLISTER,1.0X15.0X4.0 TABLET BLISTER01/07/2014
1123NDA/MAL/HDP/1399CIPLA LTD.QUALITY CHEMICALS LTD - HUMANASTHALINSALBUTAMOL100MCG/DOSECIPLA LTD .-PLOT NO. 9, 10 AND 15, INDORE SPECIAL ECONOMIC ZONE, PHASE –II, PITHAMPUR, DISTRICT DHAR, PIN CODE: 454775, MADHYA PRADESH INDIALUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER1.0X200.0 METERED DOSE CANNISTER01/07/2010
1124NDA/MAL/HDP/2175CIPLA LTDQUALITY CHEMICALS LTD - HUMANPARAFIZZPARACETAMOL500MGCIPLA LTD .-PLOT NO. 9, 10 AND 15, INDORE SPECIAL ECONOMIC ZONE, PHASE –II, PITHAMPUR, DISTRICT DHAR, PIN CODE: 454775, MADHYA PRADESH INDIAORAL SOLID ORDINARY SOLUBLE TABLETS1.0X12.0X4.0 TABLET STRIP,1.0X4.0X4.0 TABLET STRIP01/07/2005
1125NDA/MAL/HDP/3062MULTISORBQUALITY CHEMICALS LTD - HUMANLAMIVUDINE,ZIDOVUDINE, NEVIRAPINELAMIVUDINE/ZIDOVUDINE/NEVIRAPINE150MG + 300MG + 200MGCIPLA LTD .-PLOT NO. 9, 10 AND 15, INDORE SPECIAL ECONOMIC ZONE, PHASE –II, PITHAMPUR, DISTRICT DHAR, PIN CODE: 454775, MADHYA PRADESH CIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X60.0 TABLET BOTTLE01/07/2007
1126NDA/MAL/HDP/5374CIPLA LIMITED.QUALITY CHEMICALS LTD - HUMANLAMIVIR ORAL SOLUTIONLAMIVUDINE50MG/5MLCIPLA LTD .-PLOT NO. 9, 10 AND 15, INDORE SPECIAL ECONOMIC ZONE, PHASE –II, PITHAMPUR, DISTRICT DHAR, PIN CODE: 454775, MADHYA PRADESH CIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA INDIAORAL LIQUID ORDINARY LIQUIDS1.0X100.0 ML BOTTLE,1.0X240.0 ML BOTTLE01/07/2004
1127NDA/MAL/HDP/1515CIPLA LTD.QUALITY CHEMICALS LTD - HUMANCIPLACEF 1000CEFTRIAXONE1000MGCIPLA LTD C/O OKASA-OKASA PHARMA PVT LTD L-2 ADDITIONAL MIDC SATARA 415004INDIAPARENTERAL ORDINARY DRY VIALS1.0X15.0 ML VIAL 1X1 WFI AMPOULE01/07/2007
1128NDA/MAL/HDP/6284CIPLA LTDQUALITY CHEMICALS LTD - HUMANPAEDIATRIC PARACETAMOL ORAL SOLUTIONPARACETAMOL120MG/5MLCIPLA LTD INDORE -PLOT NO. 9 AND 10, INDORE SPECIAL ECONOMIC ZONE, PHASE –II, PITHAMPUR, DISTRICT DHAR, 454 775, MADHYA PRADESH - INDIA INDIAORAL LIQUID ORDINARY LIQUIDS1.0X100.0 ML BOTTLE07/11/2018
1129NDA/MAL/HDP/6061CIPLA LTD..QUALITY CHEMICALS LTD - HUMANNASEHALERMOMETASONE FUROATE50MCG /SPRAYCIPLA LTD INDORE-PLOT 9 & 10 INDORE SEZ PITHAMPUR M.P 454 775INDIANASAL TOPICAL SPRAYS WITHOUT GAS1.0X140.0 METERED DOSE BOTTLE01/07/2017
1130NDA/MAL/HDP/8250CIPLA LTD.QUALITY CHEMICALS LTD - HUMANLUMARTEM DTARTEMETHER+LUMEFANTRINE20MG+120MGCIPLA LTD INDORE-PLOT 9 & 10 INDORE SEZ PITHAMPUR M.P 454 775INDIAORAL SOLID ORDINARY SOLUBLE TABLETS1.0X12.0 TABLET BLISTER,1.0X6.0 TABLET BLISTER,1.0X30.0X6.0 TABLET BLISTER,1.0X30.0X12.0 TABLET BLISTER01/07/2017
1131NDA/MAL/HDP/5389CIPLA LTDQUALITY CHEMICALS LTD - HUMANLUMARTEMARTEMETHER + LUMEFANTRINE20MG + 120 MGCIPLA LTD INDORE-PLOT 9 & 10 INDORE SEZ PITHAMPUR M.P 454 775 CIPLA LTD., PATALGANGA UNIT I & UNIT II-PLOT NO. A-33(UNIT-I), A-42( UNIT-II), MIDC PATALGANGA, 410220 DISTRICT RAIGAD, MAHARASHTRA, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X1.0X24.0 TABLET BLISTER,1.0X1.0X6.0 TABLET BLISTER,1.0X30.0X6.0 TABLET BLISTER,1.0X1.0X12.0 TABLET BLISTER,1.0X1.0X18.0 TABLET BLISTER,1.0X30.0X12.0 TABLET BLISTER,1.0X30.0X18.0 TABLET BLISTER,1.0X30.0X24.0 TABLET BLISTER01/07/2011
1132NDA/MAL/HDP/1156CIPLA LTDQUALITY CHEMICALS LTD - HUMANFUNGICIPCLOTRIMAZOLE1%W/WCIPLA LTD ----L139 TO L-146 VERNA INDUSTRIAL ESTATE VERNA SALCETTE GOA 403 722INDIATOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE01/07/2011
1133NDA/MAL/HDP/6173CIPLA LTD..QUALITY CHEMICALS LTD - HUMANMONTAIR 5MONTELUKAST SODIUM5MGCIPLA LTD ----L139 TO L-146 VERNA INDUSTRIAL ESTATE VERNA SALCETTE GOA 403 722INDIAORAL SOLID ORDINARY CHEWABLE TABLETS1.0X10.0 TABLET BLISTER01/07/2016
1134NDA/MAL/HDP/6652CIPLA LTD.QUALITY CHEMICALS LTD - HUMANLAMIVUDINE +TENOFOVIR DISOPROXIL FUMARATELAMIVUDINE+TENOFOVIR DISOPROXIL FUMARATE300MG+300MGCIPLA LTD -MIDC PATALGANGA MS 410 220 INDIA MFG LIC: 845
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X30.0 TABLET BOTTLE01/07/2017
1135NDA/MAL/HDP/0608CIPLA LTDQUALITY CHEMICALS LTD - HUMANLOPINAVIR AND RITONAVIR TABLETS 200MG/50MGLOPINAVIR + RITONAVIR200MG + 50MGCIPLA LTD -MIDC PATALGANGA MS 410 220 INDIA MFG LIC: 845
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X120.0 TABLET BOTTLE01/07/2012
1136NDA/MAL/HDP/3480CIPLA LTDQUALITY CHEMICALS LTD - HUMANHYOSPANHYOSCINE BUTYL BROMIDE10MGCIPLA LTD -MIDC PATALGANGA MS 410 220 INDIA MFG LIC: 845
INDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER01/07/2009
1137NDA/MAL/HDP/4376CIPLA LTD.QUALITY CHEMICALS LTD - HUMANEFAVIRENZ+LAMIVUDINE & TENOFOVIR TABLETSEFAVIRENZ + LAMIVUDINE + TENOFOVIR600MG +300MG + 300MGCIPLA LTD -MIDC PATALGANGA MS 410 220 INDIA MFG LIC: 845
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X30.0 TABLET CONTAINER01/07/2016
1138NDA/MAL/HDP/6655CIPLA LTD.QUALITY CHEMICALS LTD - HUMANATORLIP-20ATORVASTATIN CALCIUM20MGCIPLA LTD -MIDC PATALGANGA MS 410 220 INDIA MFG LIC: 845
INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2004
1139NDA/MAL/HDP/2497CIPLA LTDQUALITY CHEMICALS LTD - HUMANNEVIMUNENEVIRAPINE50MG/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 BOTTLE01/07/2004
1140NDA/MAL/HDP/3286CIPLA LIMITEDQUALITY CHEMICALS LTD - HUMANLOMAC-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 BLISTER01/07/2009
1141NDA/MAL/HDP/2678CIPLA LTD.QUALITY CHEMICALS LTD - HUMANFORCAN-150FLUCONAZOLE150MGCIPLA LTD -PLOT NO. L-139, VERNA, GOA 403 722 INDIA INDIAORAL SOLID ORDINARY CAPSULES1.0X5.0 CAPSULE BLISTER01/07/2004
1142NDA/MAL/HDP/2983CIPLA LTD.QUALITY CHEMICALS LTD - HUMANFUCOL 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 BLISTER01/07/2004
1143NDA/MAL/HDP/3553CIPLA LTD.QUALITY CHEMICALS LTD - HUMANFALCIMON 25/67.5 B/LARTESUNATE+AMODIAQUINE25MG+67.5MGCIPLA LTD UNIT II-A-42 MIDC PATALGANGA DISTRICT RAIGAD MAHARASHTRA STATEINDIAORAL SOLID ORDINARY LAYERED TABLETS1.0X3.0 TABLET BLISTER,1.0X25.0X3.0 TABLET BLISTER,1.0X25.0X6.0 TABLET BLISTER01/07/2014
1144NDA/MAL/HDP/5457CIPLA LIMITEDQUALITY CHEMICALS LTD - HUMANFALCIMON 100/270 B/LARTESUNATE+AMODIAQUINE100MG+270MGCIPLA LTD UNIT II-A-42 MIDC PATALGANGA DISTRICT RAIGAD MAHARASHTRA STATEINDIAORAL SOLID ORDINARY TABLETS1.0X3.0 TABLET BLISTER,1.0X6.0 TABLET BLISTER,1.0X25.0X3.0 TABLET BLISTER,1.0X25.0X6.0 TABLET BLISTER01/07/2014
1145NDA/MAL/HDP/5458CIPLA LTDQUALITY CHEMICALS LTD - HUMANFALCIMON 50/135 B/LARTESUNATE+AMODIAQUINE50MG+135MGCIPLA LTD UNIT II-A-42 MIDC PATALGANGA DISTRICT RAIGAD MAHARASHTRA STATEINDIAORAL SOLID ORDINARY TABLETS1.0X3.0 TABLET BLISTER,1.0X25.0X3.0 TABLET BLISTER01/07/2014
1146NDA/MAL/HDP/7266CIPLA LTD.QUALITY CHEMICALS LTD - HUMANATAZANAVIR SULFATE AND RITONAVIR TABLETSATAZANAVIR SULFATE + RITONAVIR USP300 MG + 100 MGCIPLA LTD(PATALGANGA)-CIPLA LIMITED,
PLOT NO. A-42 (UNIT II),MIDC,PATALGANGADISTRICT - RAIGAD, MAHARASHTRA,INDIA
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X30.0 TABLET BOTTLE30/05/2018
1147NDA/MAL/HDP/1381CIPLA LTDQUALITY CHEMICALS LTD - HUMANLAMIVUDINE,/ ZIDOVUDINE TABLETSLAMIVUDINE,+ ZIDOVUDINE150MG+300MGCIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X60.0 TABLET BOTTLE01/07/2007
1148NDA/MAL/HDP/1384CIPLA LTDQUALITY CHEMICALS LTD - HUMANLAMIVUDINE AND ZIDOVUDINE TABLETSLAMIVUDINE + ZIDOVUDINE30MG + 60MGCIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA INDIAORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS1.0X60.0 TABLET BOTTLE01/07/2013
1149NDA/MAL/HDP/2092CIPLA LTD.QUALITY CHEMICALS LTD - HUMANDUOVIR-NLAMIVUDINE + ZIDOVUDINE + NEVIRAPINE150MG + 300MG + 200MGCIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA INDIAORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET BOTTLE,1.0X60.0 TABLET BOTTLE01/07/2004
1150NDA/MAL/HDP/2125CIPLA LTDQUALITY CHEMICALS LTD - HUMANBECLATE 100BECLOMETASONE100MCG/DOSECIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA INDIANASAL SYSTEMIC METERED-DOSE LIQUIDS1.0X200.0 METERED DOSE CANNISTER01/07/2009
1151NDA/MAL/HDP/2671CIPLA LTD..QUALITY CHEMICALS LTD - HUMANDUOLIN 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 VIAL01/07/2005
1152NDA/MAL/HDP/2910CIPLA LTDQUALITY CHEMICALS LTD - HUMANTENVIR 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 BOTTLE01/07/2009
1153NDA/MAL/HDP/3041CIPLA LTDQUALITY CHEMICALS LTD - HUMANLEVOFLOXACINLEVOFLOXACIN250MGCIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2009
1154NDA/MAL/HDP/3049CIPLA LTD..QUALITY CHEMICALS LTD - HUMANEFAVIRENZEFAVIRENZ600MGCIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA INDIAORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET BOTTLE01/07/2007
1155NDA/MAL/HDP/3088CIPLA LTDQUALITY CHEMICALS LTD - HUMANPILL 72LEVONORGESTREL0.75MGCIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA INDIAORAL SOLID ORDINARY TABLETS1.0X2.0 TABLET BLISTER01/07/2014
1156NDA/MAL/HDP/3441CIPLA LTDQUALITY CHEMICALS LTD - HUMANLEVOFLOXACINLEVOFLOXACIN500MGCIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2009
1157NDA/MAL/HDP/3548CIPLA LIMITEDQUALITY CHEMICALS LTD - HUMANBECORT 200BECLOMETASONE200MCG/DOSECIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA INDIALUNG ADMINISTRATION METERED-DOSE INHALER1.0X200.0 METERED DOSE CANNISTER01/07/2009
1158NDA/MAL/HDP/3558CIPLA LTDQUALITY CHEMICALS LTD - HUMANSEROFLO-250SALMETEROL+ FLUTICASONE PROPIONATE25MCG + 250MCGCIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA INDIALUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER1.0X120.0 METERED DOSE CANNISTER01/07/2009
1159NDA/MAL/HDP/3684CIPLA LTDQUALITY CHEMICALS LTD - HUMANI-PILLLEVONORGESTREL1.5MGCIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X1.0 TABLET BLISTER01/07/2009
1160NDA/MAL/HDP/4647CIPLA LTD..QUALITY CHEMICALS LTD - HUMANLEVOLINLEVOSALBUTAMOL50MCGCIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA INDIANASAL SYSTEMIC METERED-DOSE LIQUIDS1.0X200.0 METERED DOSE CANNISTER01/07/2013
1161NDA/MAL/HDP/5202CIPLA LIMITEDQUALITY CHEMICALS LTD - HUMANHYDROCORT INJECTIONHYDROCORTISONE SODIUM SUCCINATE100MGCIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA INDIAPARENTERAL ORDINARY DRY VIALS1.0X100.0 MG VIAL01/07/2010
1162NDA/MAL/HDP/5371CIPLA LIMITED.QUALITY CHEMICALS LTD - HUMANLAMIVUDINELAMIVUDINE10MG/MLCIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA INDIAORAL LIQUID ORDINARY LIQUIDS1.0X100.0 ML BOTTLE01/07/2007
1163NDA/MAL/HDP/5478CIPLA LTDQUALITY CHEMICALS LTD - HUMANBECLATE-50BECLOMETHASONE DIPROPIONATE50MCG/ACTUATIONCIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA INDIALUNG ADMINISTRATION METERED-DOSE INHALER1.0X1.0X200.0 METERED DOSE CANNISTER01/07/2010
1164NDA/MAL/HDP/8021CIPLA LIMITEDQUALITY CHEMICALS LTD - HUMANLAMIVIR-150 TABLETSLAMIVUDINE150MGCIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X60.0 TABLET BOTTLE01/07/2001
1165NDA/MAL/HDP/8022CIPLA LTD.QUALITY CHEMICALS LTD - HUMANLAMIVUDINE + NEVIRAPINE + ZIDOVUDINELAMIVUDINE + NEVIRAPINE + ZIDOVUDINE30MG +50MG + 60MGCIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X60.0 TABLET BOTTLE01/07/2016
1166NDA/MAL/HDP/1698CIPLA LTDQUALITY CHEMICALS LTD - HUMANAZEE-500AZITHROMYCIN500MGCIPLA LTD.-VERNA IND. ESTATE GOA 403 722 INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X1.0X3.0 TABLET BLISTER01/07/2009
1167NDA/MAL/HDP/2966CIPLA LTDQUALITY CHEMICALS LTD - HUMANTENVIRTENOFOVIR DISOPROXIL FUMARATE300MGCIPLA LTD.-VERNA IND. ESTATE GOA 403 722 INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET BOTTLE01/07/2007
1168NDA/MAL/HDP/8032CIPLA LTD.QUALITY CHEMICALS LTD - HUMANABACAVIR SULFATE/LAMIVUDINEABACAVIR SULFATE + LAMIVUDINE600 MG + 300 MGCIPLA LTD-A-33 & A-37/2/2 MIDC PATALGANGA 410220INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X30.0 TABLET BOTTLE01/07/2011
1169NDA/MAL/HDP/3141CIPLA LTD.QUALITY CHEMICALS LTD - HUMANAMLOPRESS-5AMLODIPINE BESYLATE5MGCIPLA LTD-CIPLA LTD PLOT NO L-139,VERNA IND ESTATE, VERNA GOA INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X1.0X10.0 TABLET BLISTER01/07/2007
1170NDA/MAL/HDP/3182CIPLA LTDQUALITY CHEMICALS LTD - HUMANTADACIP 20TADALAFIL20MGCIPLA LTD-CIPLA LTD PLOT NO L-139,VERNA IND ESTATE, VERNA GOA INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X4.0 TABLET BLISTER01/07/2005
1171NDA/MAL/HDP/3215CIPLA LTDQUALITY CHEMICALS LTD - HUMANSEROFLO-125MGSALMETEROL 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 CANNISTER01/07/2009
1172NDA/MAL/HDP/3920CIPLA LTDQUALITY CHEMICALS LTD - HUMANPHOTERICIN BAMPHOTERICIN B50MGCIPLA LTD-M-61, M-62 & M-63, VERNA INDUSTRIAL ESTATE VERNA GOA,INDIA INDIAPARENTERAL ORDINARY VIALS1.0X50.0 MG VIAL01/07/2011
1173NDA/MAL/HDP/1255CIPLA LTDQUALITY CHEMICALS LTD - HUMANNIFELAT RETARDNIFEDIPINE20MGCIPLA LTD-MIDC PATALGANGA 410 220 DIST. RAIGADINDIAORAL SOLID RETARD TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/1997
1174NDA/MAL/HDP/3055CIPLA LTD.QUALITY CHEMICALS LTD - HUMANABACAVIR SULFATEABACAVIR SULPHATE300MGCIPLA LTD-MIDC PATALGANGA 410 220 DIST. RAIGADINDIAORAL SOLID ORDINARY TABLETS1.0X60.0 TABLET BOTTLE01/07/2007
1175NDA/MAL/HDP/6657CIPLA LTD.QUALITY CHEMICALS LTD - HUMANMETFORMINMETFORMIN HYDROCHLORIDE500MGCIPLA LTD-MIDC PATALGANGA 410 220 DIST. RAIGADINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2010
1176NDA/MAL/HDP/4351CIPLA LTDQUALITY CHEMICALS LTD - HUMANABACAVIR SULFATEABACAVIR SULPHATE60MGCIPLA LTD-PATALGANGA UNIT II PLOT MO A-33 A42 MIDC RAIGADINDIAORAL SOLID ORDINARY TABLETS1.0X60.0 TABLET BOTTLE01/07/2010
1177NDA/MAL/HDP/0189CIPLA LTDQUALITY CHEMICALS LTD - HUMANNEVIMUNE TABLETSNEVIRAPINE200MGCIPLA LTD--PLOT NO L-139,VERNA IND ESTATE, VERNA GOA-403 INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X6.0X10.0 TABLET BLISTER,1.0X60.0 TABLET CONTAINER01/07/2001
1178NDA/MAL/HDP/3084CIPLA LIMITEDQUALITY CHEMICALS LTD - HUMANNEVIRAPINENEVIRAPINE200MGCIPLA LTD--PLOT NO L-139,VERNA IND ESTATE, VERNA GOA-403 INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X60.0 TABLET CONTAINER01/07/2007
1179NDA/MAL/HDP/3212CIPLA LTD.QUALITY CHEMICALS LTD - HUMANCLOPIVAS 75MGCLOPIDOGREL BISULPHATE75MGCIPLA 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 BLISTER01/07/2005
1180NDA/MAL/HDP/1811CIPLA LTDQUALITY CHEMICALS LTD - HUMANDUOVIR TABLETSZIDOVUDINE+ LAMIVUDINE300MG + 150MGCIPLA LTD---PLOT NO. 143 AND L-144A VERNA IND. ESTATE SALCETTE GOA 403 722 CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED - -PLOT 1-7 1ST RING ROAD, LUZIRA, KAMPALA INDIAORAL SOLID ORDINARY TABLETS1.0X6.0X10.0 TABLET BLISTER,1.0X60.0 TABLET BOTTLE01/07/2001
1181NDA/MAL/HDP/1360CIPLA LTDQUALITY CHEMICALS LTD - HUMANABAMUNE-L BABYABACAVIR SULPHATE + LAMIVUDINE60MG + 30MGCIPLA LTD-UNIT I & II A-32 & A-42 MIDC PATALGANGA 410220 DIST-RAIGAD, MAHARASHTRA INDIA INDIAORAL SOLID ORDINARY SOLUBLE TABLETS1.0X60.0 TABLET CONTAINER01/07/2016
1182NDA/MAL/HDP/1907CIPLA LTDQUALITY CHEMICALS LTD - HUMANABACAVIRABACAVIR300MGCIPLA LTD-UNIT I & II A-32 & A-42 MIDC PATALGANGA 410220, DIST- RAIGAD, MAHARASHTRA, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X60.0 TABLET BOTTLE01/07/2004
1183NDA/MAL/HDP/6326CIPLA LIMITEDQUALITY CHEMICALS LTD - HUMANONCOGEM 1000GEMCITABINE HYDROCHLORIDE1000MGCIPLA LTD-UNIT VII PRODUCTION II, PLOT NOS. S-103 TO S-105, S-107 TO S-112, L-147/1 TO L-147/3, L-138, L-147/A, VERNA INDUSTIRAL ESTATE, VERNA SALCETTE-GOA INDIAPARENTERAL ORDINARY I V VIALS1.0X1000.0 MG VIAL20/12/2018
1184NDA/MAL/HDP/3972CIPLA LTD.QUALITY CHEMICALS LTD - HUMANFERTOMID-50CLOMIPHENE50MGCIPLA LTD-VERNA INDIA ESTATES 403722 GOA INDAINDIAORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER01/07/2007
1185NDA/MAL/HDP/4368CIPLA LTD.QUALITY CHEMICALS LTD - HUMANLAMIVUDINE, NEVIRAPINE AND ZIDOVUDINE LAMIVUDINE + ZIDOVUDINE + NEVIRAPINE150MG + 300MG + 200MGCIPLA LTD-VERNA INDIA ESTATES 403722 GOA INDAINDIAORAL SOLID ORDINARY TABLETS1.0X60.0 TABLET CONTAINER01/07/2007
1186NDA/MAL/HDP/2527CIPLA LTD.QUALITY CHEMICALS LTD - HUMANACIVIR CREAMACICLOVIR5%W/WCIPLA LTD-VERNA INDUSTRIAL ESTATE, GOA INDIATOPICAL EXTERNAL CREAMS1.0X10.0 G TUBE,1.0X5.0 G TUBE01/07/1998
1187NDA/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 CONTAINER01/07/2013
1188NDA/MAL/HDP/0198CIPLA LIMITEDCIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDNEVIRAPINE TABLETS 200 MGNEVIRAPINE200MGCIPLA QUALITY CHEMICAL INDUSTRIES LIMITED - -PLOT 1-7 1ST RING ROAD, LUZIRA, KAMPALA UGANDAORAL SOLID ORDINARY TABLETS1.0X60.0 TABLET BOTTLE01/07/2013
1189NDA/MAL/HDP/0197CIPLA LTDQUALITY CHEMICALS LTD - HUMANEFAVIR-600EFAVIRENZ600MGCIPLA QUALITY CHEMICAL INDUSTRIES LIMITED - -PLOT 1-7 1ST RING ROAD, LUZIRA, KAMPALA CIPLA LTD -PLOT NO. L-139, VERNA, GOA 403 722 INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET CONTAINER01/07/2004
1190NDA/MAL/HDP/7250CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDCIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDDOLUTEGRAVIR SODIUM, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATEDOLUTEGRAVIR SODIUM +LAMIVUDINE +TENOFOVIR DISOPROXIL FUMARATE50MG + 300MG + 300MGCIPLA QUALITY CHEMICAL INDUSTRIES LIMITED (CIPLAQCIL)-PLOT 1-7, 1ST RING ROAD, LUZIRA INDUSTRIAL PARK UGANDAORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET BOTTLE29/11/2019
1191NDA/MAL/HDP/8093CIPLA LIMITEDCIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDLAMIVUDINE/ ZIDOVUDINE/ NEVIRAPINE TABLETS 150MG/300MG/200MGZIDOVUDINE + LAMIVUDINE + NEVIRAPINE 300MG + 150MG + 200MGCIPLA QUALITY CHEMICAL INDUSTRIES LIMITED (CIPLAQCIL)-PLOT 1-7, 1ST RING ROAD, LUZIRA INDUSTRIAL PARK UGANDAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X60.0 TABLET BOTTLE01/07/2010
1192NDA/MAL/HDP/7162ACG PHARMAPACK PVT. LTDCIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDTEXAVIRTENOFOVIR DISOPROXIL FUMARATE300MGCIPLA QUALITY CHEMICAL INDUSTRIES LIMITED-PLOT 1-7, LUZIRA UGANDAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X30.0 TABLET BOTTLE01/07/2017
1193NDA/MAL/HDP/1906ACG PHARMAPACK PVT. LTDCIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDEFAVIRENZ TABLETS 600MGEFAVIRENZ600MGCIPLA QUALITY CHEMICAL INDUSTRIES LIMITED-PLOT 1-7, LUZIRA UGANDAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X30.0 TABLET CONTAINER01/07/2013
1194NDA/MAL/HDP/7274CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDCIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDZENTAIR 0.5MGENTECAVIR0.5MGCIPLA QUALITY CHEMICAL INDUSTRIES LIMITED-PLOT 1-7, LUZIRA UGANDAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER01/07/2017
1195NDA/MAL/HDP/7663CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDCIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDZENTAIRENTECAVIR MONOHYDRATE1.0MGCIPLA QUALITY CHEMICAL INDUSTRIES LIMITED-PLOT 1-7, LUZIRA UGANDAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER01/07/2017
1196NDA/MAL/HDP/7449CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDCIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDLAMIVUDINE/ TENOFOVIR DF 300/300MGLAMIVUDINE+TENOFOVIR DISOPROXIL FUMARATE300MG+300MGCIPLA QUALITY CHEMICALS INDUSTRIES LIMITED--PLOT 1-7 1ST RING ROAD, LUZIRA INDUSTRIAL PARK P O BOX 34871, KAMPALA, UGANDA UGANDAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X30.0 TABLET BOTTLE31/01/2018
1197NDA/MAL/HDP/7617CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDCIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDEFAVIRENZ, LAMIVUDINE & TENOFOVIR DISOPROXIL FUMARATE TABLETS 600 MG/300 MG /300 MGEFAVIRENZ + LAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE600 MG + 300 MG + 300 MGCIPLA QUALITY CHEMICALS INDUSTRIES LIMITED--PLOT 1-7 1ST RING ROAD, LUZIRA INDUSTRIAL PARK P O BOX 34871, KAMPALA, UGANDA UGANDAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X30.0 TABLET BOTTLE28/03/2018
1198NDA/MAL/HDP/1167CIRON DRUGS AND PHARMACEUTICALS PVT LTDRENE PHARMACY LTDMETOCLOPRAMIDE INJECTIONMETOCLOPRAMIDE5MG/MLCIRON DRUGS & PHARMACEUTICALS PVT LTD .-N-118,M.I.D.C, TARAPUR,BOISAR, DIST.THANE-401506, MAHARASHTRA,INDIA. INDIAPARENTERAL ORDINARY AMPOULES1.0X10.0X10.0X2.0 ML AMPOULE01/07/2010
1199NDA/MAL/HDP/1172CIRON DRUGS AND PHARMACEUTICALS PVT LTDRENE PHARMACY LTDLIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDE 20MG/MLCIRON DRUGS & PHARMACEUTICALS PVT LTD .-N-118,M.I.D.C, TARAPUR,BOISAR, DIST.THANE-401506, MAHARASHTRA,INDIA. INDIAPARENTERAL ORDINARY VIALS1.0X20.0 ML VIAL,1.0X30.0 ML VIAL01/07/2010
1200NDA/MAL/HDP/5380CIRON DRUGS & PHARMACEUTICALS PVT LTDRENE PHARMACY LTDCIROZEPDIAZEPAM5MG/MLCIRON DRUGS & PHARMACEUTICALS PVT LTD .-N-118,M.I.D.C, TARAPUR,BOISAR, DIST.THANE-401506, MAHARASHTRA,INDIA. INDIAPARENTERAL ORDINARY AMPOULES1.0X10.0X10.0X2.0 ML AMPOULE01/07/2013
1201NDA/MAL/HDP/6548CIRON DRUGS & PHARMACEUTICAL PVT LTDROYAL PHARMA 2011 LIMITEDCIROPAIN GELDICLOFENAC DIETHYLAMINE BP1%W/WCIRON DRUGS & PHARMACEUTICALS PVT LTD--N-118, 119 MIDC TARAPUR BOISAR DIST THANE 4011 506 INDIATOPICAL EXTERNAL GELS AND SOLS1.0X20.0 G TUBE01/07/2017
1202NDA/MAL/HDP/8210CIRON DRUGS & PHARMACEUTICALS PVT LTDRENE PHARMACY LTDHYDROCORTISONE SODIUM SUCCINATE FOR INJECTION BPHYDROCORTISONE100MGCIRON DRUGS & PHARMACEUTICALS PVT LTD--N-118, 119 MIDC TARAPUR BOISAR DIST THANE 4011 506 INDIAPARENTERAL ORDINARY DRY VIALS1.0X50.0X100.0 MG VIAL01/07/2007
1203NDA/MAL/HDP/8201CIRON DRUGS AND PHARMACEUTICALS PVT LTDRENE PHARMACY LTDCENTROZINECETIRIZINE HYDROCHLORIDE5MG/5MLCIRON DRUGS & PHARMACEUTICALS PVT LTD--N-118, 119 MIDC TARAPUR BOISAR DIST THANE 4011 506 INDIAORAL LIQUID ORDINARY SYRUPS1.0X60.0 ML BOTTLE01/07/2017
1204NDA/MAL/HDP/2923CIRON DRUGS & PHARMACEUTICALS PVT LTDRENE PHARMACY LTDCOLD PLUS SYRUPPARACETAMOL + PHENYLEPHRINE HYDROCHLORIDE + CHLORPHENIRAMINE MALEATE125MG + 2.5MG + 2.5MG/ 5MLCIRON DRUGS & PHARMACEUTICALS PVT LTD--N-118, 119 MIDC TARAPUR BOISAR DIST THANE 4011 506 INDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE01/07/2014
1205NDA/MAL/HDP/7147AJANTA PHARMA LIMITEDABACUS PHARMA (AFRICA) LIMITEDBIMATBIMATOPROST0.03% W/VCIRON DRUGS & PHARMACEUTICALS PVT LTD-N-118, N-119 MIDC TARAPUR BOISAR DIST THANE 401506 MAHARASHTRA INDIA INDIAOPHTHALMIC DROPS1.0X1.0X3.0 ML VIAL30/05/2018
1206NDA/MAL/HDP/7149AJANTA PHARMA LIMITEDABACUS PHARMA (AFRICA) LIMITEDOLOPAT ODOLOPATADINE HYDROCHLORIDE0.2% W/VCIRON DRUGS & PHARMACEUTICALS PVT LTD-N-118, N-119 MIDC TARAPUR BOISAR DIST THANE 401506 MAHARASHTRA INDIA INDIAOPHTHALMIC DROPS1.0X1.0X3.0 ML VIAL30/05/2018
1207NDA/MAL/HDP/7151AJANTA PHARMA LIMITEDABACUS PHARMA (AFRICA) LIMITEDAPDROPS DXMOXIFLOXACIN HYDROCHLORIDE + DEXAMETHASONE SODIUM PHOSPHATE5MG+1MG/MLCIRON DRUGS & PHARMACEUTICALS PVT LTD-N-118, N-119 MIDC TARAPUR BOISAR DIST THANE 401506 MAHARASHTRA INDIA INDIAOPHTHALMIC DROPS1.0X1.0X5.0 ML VIAL30/05/2018
1208NDA/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 AMPOULE01/07/2014
1209NDA/MAL/HDP/3635CIRON DRUGS & PHARMACEUTICALS PVT LTDRENE PHARMACY LTDCIROGANPROMETHAZINE HYDROCHLORIDE25MG/MLCIRON DRUGS & PHARMACEUTICALS PVT LTD-N-118, N-119 MIDC TARAPUR BOISAR DIST THANE 401506 MAHARASHTRA INDIA INDIAPARENTERAL ORDINARY AMPOULES1.0X10.0X10.0X2.0 ML AMPOULE01/07/2011
1210NDA/MAL/HDP/3873CIRON DRUGS & PHARMACEUTICALS PVT LTDRENE PHARMACY LTDCHLORPROMAZINE INJECTION B.PCHLORPROMAZINE25MG/MLCIRON DRUGS & PHARMACEUTICALS PVT LTD-N-118, N-119 MIDC TARAPUR BOISAR DIST THANE 401506 MAHARASHTRA INDIA INDIAPARENTERAL ORDINARY AMPOULES1.0X10.0X10.0X2.0 ML AMPOULE01/07/2011
1211NDA/MAL/HDP/3938CIRON DRUGS & PHARMACEUTICALS PVT LTDRENE PHARMACY LTDADRENALINE INJECTIONADRENALINE1MG/MLCIRON DRUGS & PHARMACEUTICALS PVT LTD-N-118, N-119 MIDC TARAPUR BOISAR DIST THANE 401506 MAHARASHTRA INDIA INDIAPARENTERAL ORDINARY AMPOULES1.0X100.0X1.0 ML AMPOULE01/07/2013
1212NDA/MAL/HDP/4737CIRON DRUGS AND PHARMACEUTICALS PVT LTDRENE PHARMACY LTDCICOL DROPSDICYCLOMINE HYDROCHLORIDE + SIMETICONE10MG + 40MG/ 5MLCIRON DRUGS & PHARMACEUTICALS PVT LTD-N-118, N-119 MIDC TARAPUR BOISAR DIST THANE 401506 MAHARASHTRA INDIA INDIAORAL LIQUID ORDINARY DROPS1.0X10.0 ML BOTTLE01/07/2014
1213NDA/MAL/HDP/8818AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDLEVOTOP-PFLEVOFLOXACIN HEMIHYDRATE1.5%W/VCIRON DRUGS & PHARMACEUTICALS PVT LTD-N-118, N-119 MIDC TARAPUR BOISAR DIST THANE 401506 MAHARASHTRA INDIA INDIAOPHTHALMIC DROPS1.0X1.0X5.0 ML VIAL30/05/2018
1214NDA/MAL/HDP/8824AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDNEPAFLAMNEPAFENAC0.1% W/VCIRON DRUGS & PHARMACEUTICALS PVT LTD-N-118, N-119 MIDC TARAPUR BOISAR DIST THANE 401506 MAHARASHTRA INDIA INDIAOPHTHALMIC SUSPENSIONS1.0X1.0X5.0 ML VIAL30/05/2018
1215NDA/MAL/HDP/6999CIRON DRUGS & PHARMACEUTICAL PVT LTDROYAL PHARMA 2011 LIMITEDNYSTATIN ORAL SUSPENSIONNYSTATIN100000 UNITS/5MLCIRON DRUGS & PHARMACEUTICALS PVT LTD-N-118, N-119, N-113 MIDC TARAPUR BOISAR DIST. THANE 401506 MAHARASHTRA INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X30.0 ML BOTTLE31/01/2018
1216NDA/MAL/HDP/3485CIRON DRUGS & PHARMACEUTICALS PVT LTDRENE PHARMACY LTDERGOMETRINEERGOMETRINE MALEATE0.5MG/MLCIRON DRUGS AND PHARMACEUTICALS PRIVATE LTD-N-118 MIDC TARAPUM BOISAR DIST THANE 401506 MAHARASHTRA, INDIA INDIAPARENTERAL ORDINARY AMPOULES1.0X100.0X1.0 ML AMPOULE01/07/2007
1217NDA/MAL/HDP/3594CIRON DRUGS & PHARMACEUTICALS PVT LTDRENE PHARMACY LTDSTERILE QUININE DIHYDROCHLORIDEQUININE DIHYDROCHLORIDE300MG/MLCIRON DRUGS AND PHARMACEUTICALS PVT LIMITED-N-118, N119, N113, MIDC TARAPUR BOISAR DIST THANE 401506, INIDA INDIAPARENTERAL ORDINARY AMPOULES1.0X100.0X2.0 ML AMPOULE01/07/2007
1218NDA/MAL/HDP/3680CIRON DRUGS & PHARMACEUTICALS PVT LTDRENE PHARMACY LTDSUXAMETHONIUM CHLORIDE INJECTION B.PSUXAMETHONIUM CHLORIDE50MG/MLCIRON DRUGS AND PHARMACEUTICALS PVT LTD .-N-118, N119, N113, MIDC, TARAPUR, BOISAR, DIST. THANE 401506, INDIA INDIAPARENTERAL ORDINARY AMPOULES1.0X10.0X10.0X2.0 ML AMPOULE01/07/2011
1219NDA/MAL/HDP/8208CIRON DRUGS & PHARMACEUTICAL PVT LTDRENE PHARMACY LTDCHLORAMPHENICOL SODIUM SUCCINATECHLORAMPHENICOL SODIUM SUCCINATE1GCIRON DRUGS AND PHARMACEUTICALS PVT LTD-N-118 M.I.D.C, TAAPUR,BOISAR,DIST.THANE MAHARASHTRA INDIA INDIAPARENTERAL ORDINARY DRY VIALS1.0X25.0X1.0 G VIAL01/07/2007
1220NDA/MAL/HDP/1432CIRON DRUGS & PHARMACEUTICALS PVT LTDRENE PHARMACY LTDCHLORAMPHENICOL EAR DROPSCHLORAMPHENICOL5%W/VCIRON DRUGS AND PHARMACEUTICALS PVT LTD-N-118 M.I.D.C, TAAPUR,BOISAR,DIST.THANE MAHARASHTRA INDIA INDIAOTIC DROPS1.0X10.0 ML VIAL01/07/2007
1221NDA/MAL/HDP/3584CIRON DRUGS & PHARMACEUTICALS PVT LTDRENE PHARMACY LTDCHLORAMPHENICOL EYE DROPSCHLORAMPHENICOL0.5%W/VCIRON DRUGS AND PHARMACEUTICALS PVT LTD-N-118 M.I.D.C, TAAPUR,BOISAR,DIST.THANE MAHARASHTRA INDIA INDIAOPHTHALMIC DROPS1.0X1.0X10.0 ML VIAL01/07/2007
1222NDA/MAL/HDP/4587CIRON DRUGS AND PHARMACEUTICALS PVT LTDRENE PHARMACY LTDCIRATROATROPINE1MG/MLCIRON DRUGS AND PHARMACEUTICALS PVT LTD-N-118 M.I.D.C, TAAPUR,BOISAR,DIST.THANE MAHARASHTRA INDIA INDIAPARENTERAL ORDINARY AMPOULES1.0X10.0X10.0X1.0 ML AMPOULE01/07/2008
1223NDA/MAL/HDP/4979CIRON DRUGS & PHARMACEUTICALS PVT LTDRENE PHARMACY LTDFUROSEMIDEFUROSEMIDE10MG/MLCIRON DRUGS AND PHARMACEUTICALS PVT LTD-N-118 M.I.D.C, TAAPUR,BOISAR,DIST.THANE MAHARASHTRA INDIA INDIAPARENTERAL ORDINARY AMPOULES1.0X10.0X10.0X2.0 ML AMPOULE01/07/2010
1224NDA/MAL/HDP/5013CIRON DRUGS & PHARMACEUTICALS PVT LTDRENE PHARMACY LTDGENTAMYCIN EYE/EAR DROPSGENTAMYCIN0.3%W/VCIRON DRUGS AND PHARMACEUTICALS PVT LTD-N-118 M.I.D.C, TAAPUR,BOISAR,DIST.THANE MAHARASHTRA INDIA INDIAOPHTHALMIC DROPS1.0X10.0 ML VIAL01/07/2009
1225NDA/MAL/HDP/6246CIRON DRUGS & PHARMACEUTICALS PVT LTDRENE PHARMACY LTDLUTHERARTEMETHER80MG/MLCIRON DRUGS AND PHARMACEUTICALS PVT. LTD-N-118, N119, N113, MIDC, TARAPUR, BOISAR, DIST. THANE 401506, INDIA INDIAPARENTERAL ORDINARY I M AMPOULES1.0X6.0X1.0 ML AMPOULE01/07/2016
1226NDA/MAL/HDP/2670ELDA INTERNATIONAL DMCCREDDYS PHARMA LIMITEDSENSINILLIDOCAINE2%W/VCLARIS INJECTABLE LIMITED--CHACHARWADI VASANA AHMEDABAD GUJARATINDIAPARENTERAL ORDINARY VIALS1.0X5.0 ML VIAL,1.0X20.0 ML VIAL,1.0X30.0 ML VIAL,1.0X5.0X20.0 ML VIAL01/07/2005
1227NDA/MAL/HDP/6660ELDA INTERNATIONAL DMCCREDDYS PHARMA LIMITEDKETAJEXKETAMINE50MG/MLCLARIS INJECTABLE LIMITED--CHACHARWADI VASANA AHMEDABAD GUJARATINDIAPARENTERAL ORDINARY VIALS1.0X10.0 ML VIAL01/07/2005
1228NDA/MAL/HDP/2045ELDA INTERNATIONAL DMCCREDDYS PHARMA LIMITEDBUPICANBUPIVACAINE0.5% W/VCLARIS INJECTABLES LIMITED---CHACHARWADI VASANA 382 213 AHMEDABAD GUJARATINDIAPARENTERAL ORDINARY VIALS1.0X20.0 ML VIAL01/07/2006
1229NDA/MAL/HDP/3396ELDA INTERNATIONAL DMCCREDDYS PHARMA LIMITEDBUPICAN HEAVYBUPIVACAINE HYDROCHLORIDE IN DEXTROSE0.5%W/VCLARIS INJECTABLES LIMITED---CHACHARWADI VASANA 382 213 AHMEDABAD GUJARATINDIAPARENTERAL ORDINARY AMPOULES1.0X25.0X4.0 ML AMPOULE01/07/2007
1230NDA/MAL/HDP/5438ELDA INTERNATIONAL DMCCREDDYS PHARMA LIMITEDTAMINPARACETAMOL10MG/MLCLARIS INJECTABLES LIMITED---CHACHARWADI VASANA 382 213 AHMEDABAD GUJARATINDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X100.0 ML BOTTLE,1.0X1.0X50.0 ML BOTTLE,1.0X1.0X100.0 ML VIAL01/07/2013
1231NDA/MAL/HDP/7593AMRING PHARMAERIS LTDPARACETAMOL AMRINGPARACETAMOL10 MG/MLCLARIS INJECTABLES LIMITED-VASANA-CHACHARWADI, TAL-SANAND-382 213, INDIA INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X1.0X100.0 ML BOTTLE27/11/2019
1232NDA/MAL/HDP/9168AMRING FARMA S.R.LERIS LTDZOLEDRONIC ACIDZOLEDRONIC MONOHYDRATE0.8 MG/MLCLARIS INJECTABLES LIMITED-VASANA-CHACHARWADI, TAL-SANAND-382 213, INDIA CUBAPARENTERAL ORDINARY VIALS1.0X5.0 ML VIAL27/11/2019
1233NDA/MAL/HDP/3797ELDA INTERNATIONAL DMCCREDDYS PHARMA LIMITEDPROVIVE 1%PROPOFOL10MG/MLCLARIS LIFE SCIENCES LIMITED-CHACHOSWADIII VASNA.AHMEDABAD-382213,INDIA INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X50.0 ML VIAL,1.0X20.0 ML VIAL01/07/2002
1234NDA/MAL/HDP/6140CLARIS OTSUKA LIMITEDREDDYS PHARMA LIMITEDKIDROLYTESODIUM ACETATE + DIBASIC POTASSIUM PHOSPHATE + MAGNESSIUM CHLORIDE + DEXTROSE MONONOHYDRATE + POTASSIUM CHLORIDE(0.32G + 0.026G + 0.031G + 5.50G + 0.13G)/100MLCLARIS OTSUKA LIMITED .-VILLAGE VASANA CHACHARWADI TAL:SANAD DIST -AHMEDABAD 382 213INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X500.0 ML BOTTLE01/07/2016
1235NDA/MAL/HDP/5028THE MENTHOLATUM COMPANY LTD TWYHARLEYS UGANDA LIMITEDDEEP HEAT SPRAYMULTI-INGREDIENTMULTI-INGREDIENTCOLEP LAUPHEIM GMBH & CO KG-FOCKESTRASSE 12, 88471, LAUPHEIM THE MENTHOLATUM COMPANY LTD, TWYFORD,-1 REDWOOD AVENUE, PEEL PARK CAMPUS EAST KILBRIDE, G74 SCOTLAND UNITED KINGDOMTOPICAL EXTERNAL PRESSURISED AEROSOLS1.0X150.0 ML CANNISTER01/07/1997
1236NDA/MAL/HDP/6924I CARE PHARMA LIMITEDAIVEEN (U) LIMITEDNAC MRDICLOFENAC POTASSIUM+PARACETAMOL+CHLORZOXAZONE50MG+325MG+250MGCORONA REMEDIES PVT LIMITED-VILLAGE JATOLI, POST OFFICE - OACHGHAT, TEHSIL SOLAN, DIST. SOLAN HIMACHAL PRADESH – 173223. INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER31/01/2018
1237NDA/MAL/HDP/7003I CARE PHARMA LIMITEDAIVEEN (U) LIMITEDNAC-SPDICLOFENAC POTASSIUM + SERRATIOPEPTIDASE50MG + 10MGCORONA REMEDIES PVT LTD..-VILLAGE JATOLI,
POST OFFICE - OACHGHAT,
TEHSIL SOLAN, DIST. SOLAN
HIMACHAL PRADESH
INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER01-07-19
1238NDA/MAL/HDP/6920I CARE PHARMA LIMITEDAIVEEN (U) LTD - WILSON ROADOFZOLEOFLOXACIN+ORNIDAZOLE200MG+500MGCORONA REMEDIES PVT LTD..-VILLAGE JATOLI,
POST OFFICE - OACHGHAT,
TEHSIL SOLAN, DIST. SOLAN
HIMACHAL PRADESH
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X10.0 TABLET BLISTER03/12/2018
1239NDA/MAL/HDP/7596INTERNATIONAL ORGANIZATION FOR MIGRATIONAIVEEN (U) LTD - WILSON ROADPEGASET 150PREGABALIN150 MGCORONA REMEDIES PVT LTD..-VILLAGE JATOLI,
POST OFFICE - OACHGHAT,
TEHSIL SOLAN, DIST. SOLAN
HIMACHAL PRADESH
INDIAORAL SOLID ORDINARY CAPSULES1.0X4.0X7.0 CAPSULE BLISTER27/11/2019
1240NDA/MAL/HDP/6365I CARE PHARMA LIMITEDAIVEEN (U) LIMITEDEASY PILLLEVONORGESTREL1.5MGCORONA REMEDIES PVT LTD-CORONA HOUSE, C MONDEAL BUSINESS PARK, NR. GURUDWARA GOVINDDHAM LANE, SG HIGHWAY, THALTEJ, AHMEDABAD 380059, GUJARAT INDIAORAL SOLID ORDINARY TABLETS1.0X1.0 TABLET BLISTER28/03/2019
1241NDA/MAL/HDP/6988I-CARE PHARMA LTDAIVEEN (U) LIMITEDESZOLEESOMEPRAZOLE MAGNESIUM TRIHYDRATE40 MGCORONA REMEDIES PVT. LTD-VILLAGE JATOLI, POST OFFICE- OACHGHAT, TEHSIL, SOLAN, DISTT. SOLAN (H.P) 173223 INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER28/08/2019
1242NDA/MAL/HDP/7454MEDISEL(K) LTDAIVEEN (U) LIMITEDGITITOPRIDE HYDROCHLORIDE150MGCORONA REMEDIES PVT. LTD-VILLAGE JATOLI, POST OFFICE- OACHGHAT, TEHSIL, SOLAN, DISTT. SOLAN (H.P) 173223 INDIAOPHTHALMIC DROPS1.0X1.0X10.0 TABLET BLISTER28/11/2019
1243NDA/MAL/HDP/7526CORONA REMEDIES PVT. LTDAIVEEN (U) LIMITEDMANIGRA 100SILDENAFIL CITRATE100 MGCORONA REMEDIES PVT. LTD-VILLAGE JATOLI, POST OFFICE- OACHGHAT, TEHSIL, SOLAN, DISTT. SOLAN (H.P) 173223 INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X4.0 TABLET BLISTER27/11/2019
1244NDA/MAL/HDP/7527I-CARE PHARMA LTDAIVEEN (U) LIMITEDMANIGRA 50SILDENAFIL CITRATE50 MGCORONA REMEDIES PVT. LTD-VILLAGE JATOLI, POST OFFICE- OACHGHAT, TEHSIL, SOLAN, DISTT. SOLAN (H.P) 173223 INDIAORAL SOLID ORDINARY TABLETS1.0X1.0X4.0 TABLET BLISTER27/11/2019
1245NDA/MAL/HDP/7528I-CARE PHARMA LTDAIVEEN (U) LIMITEDMANIGRA PLUSSILDENAFIL CITRATE + DAPOXETINE HYDROCHLORIDE100MG + 60MGCORONA REMEDIES PVT. LTD-VILLAGE JATOLI, POST OFFICE- OACHGHAT, TEHSIL, SOLAN, DISTT. SOLAN (H.P) 173223 INDIAORAL SOLID ORDINARY TABLETS1.0X4.0 TABLET BLISTER27/11/2019
1246NDA/MAL/HDP/9136I CARE PHARMA LIMITEDAIVEEN (U) LIMITEDI-CEF DPSCEFIXIME50MG/5MLCORONA REMEDIES PVT. LTD-VILLAGE JATOLI, POST OFFICE- OACHGHAT, TEHSIL, SOLAN, DISTT. SOLAN (H.P) 173223 INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE26/11/2019
1247NDA/MAL/HDP/9137I CARE PHARMA LIMITEDAIVEEN (U) LIMITEDDOM RRABEPRAZOLE SODIUM + DOMPERIDONE SR20MG + 30MGCORONA REMEDIES PVT. LTD-VILLAGE JATOLI, POST OFFICE- OACHGHAT, TEHSIL, SOLAN, DISTT. SOLAN (H.P) 173223 INDIAORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER26/11/2019
1248NDA/MAL/HDP/9138I CARE PHARMA LIMITEDAIVEEN (U) LIMITEDL-THROX 50LEVOTHYROXINE SODIUM50MCGCORONA REMEDIES PVT. LTD-VILLAGE JATOLI, POST OFFICE- OACHGHAT, TEHSIL, SOLAN, DISTT. SOLAN (H.P) 173223 INDIAORAL SOLID ORDINARY TABLETS1.0X100.0 TABLET BOTTLE26/11/2019
1249NDA/MAL/HDP/9139I CARE PHARMA LIMITEDAIVEEN (U) LIMITEDL THROX 100LEVOTHYROXINE SODIUM100MCGCORONA REMEDIES PVT. LTD-VILLAGE JATOLI, POST OFFICE- OACHGHAT, TEHSIL, SOLAN, DISTT. SOLAN (H.P) 173223 INDIAORAL SOLID ORDINARY TABLETS1.0X100.0 TABLET BOTTLE26/11/2019
1250NDA/MAL/HDP/9140I CARE PHARMA LIMITEDAIVEEN (U) LIMITEDCLOMIPHENE CITRATECLOMIPHENE CITRATE50MGCORONA REMEDIES PVT. LTD-VILLAGE JATOLI, POST OFFICE- OACHGHAT, TEHSIL, SOLAN, DISTT. SOLAN (H.P) 173223 INDIAORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER26/11/2019
1251NDA/MAL/HDP/9141I CARE PHARMA LIMITEDAIVEEN (U) LIMITEDRABZOLERABEPRAZOLE SODIUM + LEVOSULPIRIDE20MG + 75MGCORONA REMEDIES PVT. LTD-VILLAGE JATOLI, POST OFFICE- OACHGHAT, TEHSIL, SOLAN, DISTT. SOLAN (H.P) 173223 INDIAORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER26/11/2019
1252NDA/MAL/HDP/8180COSMOS LTDASTRA PHARMA (U) LIMITEDCOSMOL TABLETS 500MGPARACETAMOL500MGCOSMOS LIMITED -RANGWA ROAD, OFF LUNGA LUNGA ROAD, INDUSTRIAL AREA KENYAORAL SOLID ORDINARY TABLETS1.0X50.0X2.0 TABLET STRIP,1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER01/07/1997
1253NDA/MAL/HDP/1911COSMOS LTDASTRA PHARMA (U) LIMITEDCODEINE PHOSPHATE TABLETS BP 30CODEINE PHOSPHATE30MGCOSMOS LIMITED -RANGWA ROAD, OFF LUNGA LUNGA ROAD, INDUSTRIAL AREA KENYAORAL SOLID ORDINARY TABLETS1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER01/07/1998
1254NDA/MAL/HDP/5370COSMOS LTDASTRA PHARMA (U) LIMITEDHYOSCINE BUTYLBROMIDEHYOSCINE N-BUTYLBROMIDE10 MGCOSMOS LIMITED -RANGWA ROAD, OFF LUNGA LUNGA ROAD, INDUSTRIAL AREA KENYAORAL SOLID ORDINARY OTHER COATED TABLETS1.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET BLISTER01/07/2005
1255NDA/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 BOTTLE01/07/2012
1256NDA/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 BLISTER01/07/2013
1257NDA/MAL/HDP/0784COSMOS LTDASTRA PHARMA (U) LIMITEDHEMOSANFERROUS FUMERATE300MGCOSMOS LIMITED, KENYA-RANGWE ROAD, OFF LUNGA ROAD, INDUSTRIAL AREA
NAIROBI - KENYA
KENYAORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER01/07/2013
1258NDA/MAL/HDP/0746COSMOS LTDASTRA PHARMA (U) LIMITEDDTS-Z KITTABLET-ZINC, SACHET-NACL + KCL + TRISODIUM CITRATE + ANHYDROUS GLUCOSETABLET-54.89MG , SACHET 1.3G + 0.75G + 1.45G + 6.75GCOSMOS LIMITED, KENYA-RANGWE ROAD, OFF LUNGA ROAD, INDUSTRIAL AREA
NAIROBI - KENYA
KENYAORAL LIQUID ORDINARY UNIT DOSE POWDERS1.0X4.0X10.3 G SACHET + 1.0X10.0 TABLET BLISTER01/07/2013
1259NDA/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 BLISTER01/07/2012
1260NDA/MAL/HDP/4710COSMOS LTDASTRA PHARMA (U) LIMITEDMEDOPRESS TABLETS 250MGMETHYLDOPA250MGCOSMOS LIMITED..-RANGWE ROAD, OFF LUNGA LUNGA ROAD, INDUSTRIAL AREA KENYAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER01/07/1998
1261NDA/MAL/HDP/8297COSMOS LTDASTRA PHARMA (U) LIMITEDISONIAZIDE TABLETSISONIAZID100MGCOSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA KENYAORAL SOLID ORDINARY TABLETS10.0X10.0 TABLET BLISTER,1000.0 TABLET CONTAINER01/07/2001
1262NDA/MAL/HDP/2374COSMOS LTDASTRA PHARMA (U) LIMITEDPYRAZINAMIDE TABLETSPYRAZINAMIDE500MGCOSMOS 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 STRIP01/07/1997
1263NDA/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 CONTAINER01/07/1998
1264NDA/MAL/HDP/1856COSMOS LTDASTRA PHARMA (U) LIMITEDPROPRANOLOL TABLETS B.P. 40MGPROPRANOLOL HYDROCHLORIDE40MGCOSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA KENYAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER01/07/1998
1265NDA/MAL/HDP/1254COSMOS LTDASTRA PHARMA (U) LIMITEDCOSATRIM TABLETSCO-TRIMOXAZOLE480MGCOSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA KENYAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER01/07/1998
1266NDA/MAL/HDP/0141COSMOS LTDASTRA PHARMA (U) LIMITEDNYCOSTAT SUSPENSIONNYSTATIN100,000 I.U/MLCOSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA KENYAORAL LIQUID ORDINARY SUSPENSIONS1.0X30.0 ML BOTTLE01/07/1998
1267NDA/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 BLISTER01/07/1998
1268NDA/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 CONTAINER01/07/2000
1269NDA/MAL/HDP/0948COSMOS LTDASTRA PHARMA (U) LIMITEDLORHISTINA SYRUP 5MG/5MLLORATADINE5MG/5MLCOSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA KENYAORAL LIQUID ORDINARY LIQUIDS1.0X60.0 ML BOTTLE01/07/2013
1270NDA/MAL/HDP/3516COSMOS LTDASTRA PHARMA (U) LIMITEDBENZHEXOL TABLETS BP 5MGTRIHEXYPHENIDYL HYDROCHLORIDE5MGCOSMOS 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 BLISTER01/07/1998
1271NDA/MAL/HDP/3752COSMOS LTDASTRA PHARMA (U) LIMITEDPAINOTAB 200PARACETAMOL/CAFFEINE500MG+65MGCOSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA KENYAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2003
1272NDA/MAL/HDP/3837COSMOS LTDASTRA PHARMA (U) LIMITEDNITROFURANTOINNITROFURANTOIN100MGCOSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA KENYAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER01/07/1998
1273NDA/MAL/HDP/4400COSMOS LTDASTRA PHARMA (U) LIMITEDORAL REHYDRATION SALT (DTS)ORAL REHYDRATION SALTN/ACOSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA KENYAORAL LIQUID ORDINARY SOLUBLE POWDERS1.0X100.0X20.6 G SACHET,1.0X100.0X10.3 G SACHET01/07/1997
1274NDA/MAL/HDP/4544COSMOS LTDASTRA PHARMA (U) LIMITEDSALBUT TABLET 4MGSALBUTAMOL4MGCOSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA KENYAORAL SOLID ORDINARY FILM-COATED TABLETS10.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CONTAINER01/07/2000
1275NDA/MAL/HDP/4974COSMOS LTDASTRA PHARMA (U) LIMITEDFRUSEMIDE TABLETS BP 40MGFUROSEMIDE40MGCOSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA KENYAORAL SOLID ORDINARY TABLETS1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER01/07/1998
1276NDA/MAL/HDP/5042COSMOS LTDASTRA PHARMA (U) LIMITEDCOSATRIM DS TABLETSCO-TRIMOXAZOLE960MGCOSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA KENYAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X500.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER01/07/1998
1277NDA/MAL/HDP/5099COSMOS LTDASTRA PHARMA (U) LIMITEDGLUCOMETMETFORMIN500MGCOSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA KENYAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER,1.0X4.0X14.0 TABLET BLISTER01/07/2005
1278NDA/MAL/HDP/5200COSMOS LTDASTRA PHARMA (U) LIMITEDHYDRALAZINE TABLETS B.P 25MG.HYDRALAZINE HYDROCHLORIDE25MGCOSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA KENYAORAL SOLID ORDINARY TABLETS1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER01/07/1998
1279NDA/MAL/HDP/2319COSMOS LTDASTRA PHARMA (U) LIMITEDCOSMOLPARACETAMOL120MG/5MLCOSMOS LIMITED-RANGWE ROAD, OFF LUNGA ROAD - INDUSTRIAL AREA NAROBI KENYAORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE01/07/1998
1280NDA/MAL/HDP/2101COSMOS LTDASTRA PHARMA (U) LIMITEDCARDISPRINACETYL SALICYLIC ACID75MGCOSMOS LIMITED-RANGWE ROAD, OFF LUNGA ROAD - INDUSTRIAL AREA NAROBI KENYAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X14.0 TABLET BLISTER01/07/2010
1281NDA/MAL/HDP/3761COSMOS LTDASTRA PHARMA (U) LIMITEDRIFACOS-300RIFAMPICIN300 MGCOSMOS LIMITED-RANGWE ROAD, OFF LUNGA ROAD - INDUSTRIAL AREA NAROBI KENYAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER01/07/1998
1282NDA/MAL/HDP/6917COSMOS LIMITEDASTRA PHARMA (U) LIMITEDDAPSONEDAPSONE100 MGCOSMOS LTD -RANGWE ROAD OFF LUNGA LUNGA ROAD INDUSTRIAL AREA NAIROBIKENYAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER28/08/2019
1283NDA/MAL/HDP/6728COSMOS LTDASTRA PHARMA (U) LIMITEDCIPROCOS-500 TABLETSCIPROFLOXACIN500MGCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI KENYAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER,10.0X10.0 TABLET BLISTER01/07/2000
1284NDA/MAL/HDP/8009COSMOS LTD.ASTRA PHARMA (U) LIMITEDGRISO-500GRISEOFULVIN500MGCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI KENYAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/1998
1285NDA/MAL/HDP/8010COSMOS LTD.ASTRA PHARMA (U) LIMITEDMETROZOLE TABLETSMETRONIDAZOLE200MGCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI KENYAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER01/07/2001
1286NDA/MAL/HDP/6762COSMOS LTDASTRA PHARMA (U) LIMITEDFLUCOLD CAPSULESMULTIINGREDIENTNACOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI KENYAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER01/07/1998
1287NDA/MAL/HDP/6729COSMOS LTDASTRA PHARMA (U) LIMITEDCOSCOF 'C' LINCTUSMULTI-INGREDIENTMULTI-INGREDIENTCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI KENYAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE01/07/2010
1288NDA/MAL/HDP/6732COSMOS LTDASTRA PHARMA (U) LIMITEDCOSCOF EXPECTORANT ORIGINALMULTI-INGREDIENTMULTI-INGREDIENTCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI KENYAORAL LIQUID ORDINARY SYRUPS1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE01/07/2010
1289NDA/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 STRIP01/07/1997
1290NDA/MAL/HDP/0424COSMOS LTDASTRA PHARMA (U) LIMITEDCHLORPROMAZINE TABLETS B.P 25MGCHLORPROMAZINE25MGCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI KENYAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER01/07/1998
1291NDA/MAL/HDP/0278COSMOS LTDASTRA PHARMA (U) LIMITEDCHLORPROMAZINE TABLETS B.P 100MGCHLORPROMAZINE HYDROCHLORIDE100MGCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI KENYAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER01/07/1998
1292NDA/MAL/HDP/2043COSMOS LTDASTRA PHARMA (U) LIMITEDDIASTOP TABLETSATTAPULGITE/ ALUMINIUM HYDROXIDEN/ACOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI KENYAORAL SOLID ORDINARY TABLETS1.0X25.0X4.0 TABLET STRIP01/07/1998
1293NDA/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 CONTAINER01/07/2000
1294NDA/MAL/HDP/2046COSMOS LTDASTRA PHARMA (U) LIMITEDLORHISTINALORATADINE10MGCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI KENYAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2005
1295NDA/MAL/HDP/1730COSMOS LTDASTRA PHARMA (U) LIMITEDZITHROXAZITHROMYCIN500MGCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI KENYAORAL SOLID ORDINARY TABLETS1.0X3.0 TABLET BLISTER01/07/2008
1296NDA/MAL/HDP/2009COSMOS LTDASTRA PHARMA (U) LIMITEDZITHROXAZITHROMYCIN200MG/5MLCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI KENYAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X15.0 ML BOTTLE,1.0X30.0 ML BOTTLE01/07/2010
1297NDA/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 CONTAINER01/07/2005
1298NDA/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 BLISTER01/07/2008
1299NDA/MAL/HDP/3610COSMOS LTDASTRA PHARMA (U) LIMITEDPROMETHAZINE TABLETS BP 25MGPROMETHAZINE HYDROCHLORIDE25MGCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI KENYAORAL SOLID ORDINARY TABLETS10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER01/07/1998
1300NDA/MAL/HDP/4148COSMOS LIMITEDASTRA PHARMA (U) LIMITEDAMITRIPTYLINE TABLETSAMITRIPTYLINE25MGCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI KENYAORAL SOLID ORDINARY TABLETS10.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER01/07/1998
1301NDA/MAL/HDP/4982COSMOS LTDASTRA PHARMA (U) LIMITEDCOSMAG TABLETSMAGNESIUM TRISILICATE370MGCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI KENYAORAL SOLID ORDINARY CHEWABLE TABLETS1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER01/07/1998
1302NDA/MAL/HDP/5164COSMOS LTDASTRA PHARMA (U) LIMITEDBROMSAL EXPECTORANTSALBUTAMOL SULPHATE+BROMHEXINE HYDROCHLORIDE+GUAIFENESIN+MENTHOL1MG+2MG+50MG+0.5MGCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI KENYAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE01/07/2010
1303NDA/MAL/HDP/5259COSMOS LTDASTRA PHARMA (U) LIMITEDCARDINOL TABLETATENOLOL100MGCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI KENYAORAL SOLID ORDINARY FILM-COATED TABLETS2.0X14.0 TABLET STRIP01/07/1997
1304NDA/MAL/HDP/5334COSMOS LTDASTRA PHARMA (U) LIMITEDETHAM-400ETHAMBUTOL400MGCOSMOS 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 CONTAINER01/07/1997
1305NDA/MAL/HDP/6918RESONANT PHARMACEUTICALSSHREEJI PHARMACEUTICALS LIMITEDNO COLDPARACTAMOL + PHENYL HYDROCHLORIDE + CHLORPHENAMINE MALEATE + CAFFEINE ANHYDROUS500MG + 10MG + 2MG + 30MGCRIS PHARMA (INDIA) LIMITED-E-11, UPSIDC INDUSTRIAL AREA, SELAQUI, DEHRADUN, UTTARAKHAND INDIA UGANDAORAL SOLID ORDINARY TABLETS1.0X50.0X4.0 TABLET BLISTER,1.0X25.0X4.0 TABLET BLISTER28/08/2019
1306NDA/MAL/HDP/7500RESONANT PHARMACEUTICALSSHREEJI PHARMACEUTICALS LIMITEDDICLOZONE MR TABLETSDICLOFENAC POTASSIUM + PARACETAMOL + CHLORZOXAZONE50 MG + 325 MG + 250 MGCRIS PHARMA (INDIA) LIMITED-E-11, UPSIDC INDUSTRIAL AREA, SELAQUI, DEHRADUN, UTTARAKHAND INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER27/11/2019
1307NDA/MAL/HDP/7517RESONANT PHARMACEUTICALS PVT LTDSHREEJI PHARMACEUTICALS LIMITEDLEVOCET-MLEVOCETIRIZINE DIHYDROCHLORIDE + MONTELUKAST SODIUM5MG + 10MGCRIS PHARMA (INDIA) LIMITED-E-11, UPSIDC INDUSTRIAL AREA, SELAQUI, DEHRADUN, UTTARAKHAND INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER27/11/2019
1308NDA/MAL/HDP/7518RESONANT PHARMACEUTICALSSHREEJI PHARMACEUTICALS LIMITEDLEVOCET-M SUSPENSIONLEVOCETIRIZINE DIHYDROCHLORIDE + MONTELUKAST SODIUM2.5MG / 5ML + 4MG / 5MLCRIS PHARMA (INDIA) LIMITED-E-11, UPSIDC INDUSTRIAL AREA, SELAQUI, DEHRADUN, UTTARAKHAND INDIA INDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X1.0X100.0 ML BOTTLE27/11/2019
1309NDA/MAL/HDP/7600RESONANT PHARMACEUTICALS PVT LTDSHREEJI PHARMACEUTICALS LIMITEDNO COLD SYRUPPARACTAMOL + PHENYL HYDROCHLORIDE + CHLORPHENAMINE MALEATE + SODIUM CITRATE125MG + 5MG + 1MG + 60MG / 5MLCRIS PHARMA (INDIA) LIMITED-E-11, UPSIDC INDUSTRIAL AREA, SELAQUI, DEHRADUN, UTTARAKHAND INDIA INDIAORAL LIQUID ORDINARY LIQUIDS1.0X1.0X100.0 ML BOTTLE27/11/2019
1310NDA/MAL/HDP/2989METRO PHARMACEUTICALS LIMITEDMETRO PHARMACEUTICALS LIMITEDDICLOFENACDICLOFENAC25MG/MLCSPC OUYI PHARMACEUTICAL CO. LTD.-WORKSHOPS 112,113 AND 117 PLOT NO. 88 YANGZI ROAD,ECONOMIC AND TECHNOLOGICAL DEVELOPMENT ZONE, SHIJIAZHUANG CITY, HEBEI PROVINCE, CHINA CHINAPARENTERAL ORDINARY AMPOULES1.0X10.0X10.0X3.0 ML AMPOULE01/07/2011
1311NDA/MAL/HDP/5006METRO PHARMACEUTICALS LIMITEDMETRO PHARMACEUTICALS LIMITEDGENTAMICIN SULPHATEGENTAMICIN SULPHATE40MG/MLCSPC OUYI PHARMACEUTICAL CO. LTD.-WORKSHOPS 112,113 AND 117 PLOT NO. 88 YANGZI ROAD,ECONOMIC AND TECHNOLOGICAL DEVELOPMENT ZONE, SHIJIAZHUANG CITY, HEBEI PROVINCE, CHINA CHINAPARENTERAL ORDINARY AMPOULES1.0X10.0X10.0X2.0 ML AMPOULE01/07/2011
1312NDA/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 VIAL01/07/2001
1313NDA/MAL/HDP/3522GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDCLOXACILLIN SODIUM FOR INJECTIONCLOXACILLIN SODIUM500MGCSPC ZHONGNUO PHARMACEUTICAL (SCIJIAZHUANG) CO. LTD WORKSHOP -NO. 88 YANGZI ROAD, SHIJIAZHUANG CITY, HEBEI PROVINCE, CHINA WORKSHOP 406 AND 407 CHINAPARENTERAL ORDINARY VIALS1.0X10.0X500.0 MG VIAL01/07/2011
1314NDA/MAL/HDP/4241GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAMPICILLIN SODIUM FOR INJECTION BPAMPICILLIN SODIUM500MGCSPC ZHONGNUO PHARMACEUTICAL (SCIJIAZHUANG) CO. LTD WORKSHOP -NO. 88 YANGZI ROAD, SHIJIAZHUANG CITY, HEBEI PROVINCE, CHINA WORKSHOP 406 AND 407 CHINAPARENTERAL ORDINARY DRY VIALS1.0X10.0X500.0 MG VIAL01/07/2011
1315NDA/MAL/HDP/4969GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDBENZATHINE PENICILLINBENZATHINE PENICILLIN2.4 M.UCSPC ZHONGNUO PHARMACEUTICAL (SCIJIAZHUANG) CO. LTD WORKSHOP -NO. 88 YANGZI ROAD, SHIJIAZHUANG CITY, HEBEI PROVINCE, CHINA WORKSHOP 406 AND 407 CHINAPARENTERAL ORDINARY DRY VIALS1.0X2.4 MU VIAL01/07/2001
1316NDA/MAL/HDP/5644GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDFORTIFIED PROCAINE PENICILLINFORTIFIED PROCAINE PENICILLIN4 MEGA UNITSCSPC ZHONGNUO PHARMACEUTICAL (SCIJIAZHUANG) CO. LTD WORKSHOP -NO. 88 YANGZI ROAD, SHIJIAZHUANG CITY, HEBEI PROVINCE, CHINA WORKSHOP 406 AND 407 CHINAPARENTERAL ORDINARY VIALS1.0X4.0 MU VIAL01/07/2001
1317NDA/MAL/HDP/0266ASTRA PHARMA (UK) LTDASTRA PHARMA (U) LIMITEDBENZATHINE PENICILLIN INJECTIONBENZATHINE PENICILLIN2.400.000 IUCSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG)CO. LTD-NO. 88, YANGZI ROAD, SHIJIAZHUANG CITY, HEBEI PROVINCE(WORKSHOP 406 AND 407) CHINAPARENTERAL ORDINARY DRY VIALS1.0X50.0 VIAL CARTON01/07/2001
1318NDA/MAL/HDP/1924ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDAMPICILLIN SODIUMAMPICILLIN SODIUM500MGCSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG)CO. LTD-NO. 88, YANGZI ROAD, SHIJIAZHUANG CITY, HEBEI PROVINCE(WORKSHOP 406 AND 407) CHINAPARENTERAL ORDINARY DRY VIALS1.0X50.0X500.0 MG VIAL01/07/2013
1319NDA/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 CARTON01/07/2001
1320NDA/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 CARTON01/07/2001
1321NDA/MAL/HDP/3618ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDCLOXACILLIN SODIUMCLOXACILLIN SODIUM500MGCSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG)CO. LTD-NO. 88, YANGZI ROAD, SHIJIAZHUANG CITY, HEBEI PROVINCE(WORKSHOP 406 AND 407) CHINAPARENTERAL ORDINARY DRY VIALS1.0X50.0 VIAL CARTON01/07/2011
1322NDA/MAL/HDP/3817ROYAL PHARMAROYAL PHARMA 2011 LIMITEDBENZYLPENICILLIN INJECTIONBENZYLPENICILLIN SODIUM1000000 I.UCSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG)CO. LTD-NO. 88, YANGZI ROAD, SHIJIAZHUANG CITY, HEBEI PROVINCE(WORKSHOP 406 AND 407) CHINAPARENTERAL ORDINARY DRY VIALS1.0X1.0 MU VIAL01/07/2002
1323NDA/MAL/HDP/3717GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDCEFTRIAXONE SODIUMCEFTRIAXONE SODIUM1GCSPC ZHONGNUO PHARMACEUTICALS LTD-NO. 88, YANGZI ROAD, SHIJIAZHUANG CITY CHINA CHINAPARENTERAL ORDINARY DRY VIALS1.0X1.0 G VIAL,1.0X10.0X1.0 G VIAL01/07/2011
1324NDA/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 BLISTER01/07/2009
1325NDA/MAL/HDP/2437DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDGAMA PHARMACEUTICALS (U) LIMITEDRISDONERISPERIDONE1MG/MLDAR AI DAWA-NA UR PLANT,AMMAN,JORDAN JORDANORAL LIQUID ORDINARY LIQUIDS1.0X100.0 ML BOTTLE01/07/2012
1326NDA/MAL/HDP/1055DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDGAMA PHARMACEUTICALS (U) LIMITEDROZITTA 40ROSUVASTATIN CALCIUM40MGDAR AI DAWA-NA UR PLANT,AMMAN,JORDAN JORDANORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET STRIP01/07/2013
1327NDA/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 STRIP01/07/2013
1328NDA/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 STRIP01/07/2013
1329NDA/MAL/HDP/3500DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDGAMA PHARMACEUTICALS (U) LIMITEDGIZLAN 300IRBESARTAN300MGDAR AI DAWA-NA UR PLANT,AMMAN,JORDAN JORDANORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2014
1330NDA/MAL/HDP/4078DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDGAMA PHARMACEUTICALS (U) LIMITEDEPIGABPREGABALIN75MGDAR AI DAWA-NA UR PLANT,AMMAN,JORDAN JORDANORAL SOLID ORDINARY CAPSULES1.0X14.0 CAPSULE BLISTER01/07/2013
1331NDA/MAL/HDP/4945DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDGAMA PHARMACEUTICALS (U) LIMITEDFORMITMETFORMIN850MGDAR AI DAWA-NA UR PLANT,AMMAN,JORDAN JORDANORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2011
1332NDA/MAL/HDP/5046DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDGAMA PHARMACEUTICALS (U) LIMITEDGIZLAN PLUS 150/12.5IRBESARTAN+HYDROCHLOROTHIAZIDE150MG+12.5MGDAR AI DAWA-NA UR PLANT,AMMAN,JORDAN JORDANORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET STRIP01/07/2013
1333NDA/MAL/HDP/5049DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDGAMA PHARMACEUTICALS (U) LIMITEDGIZLAN PLUS 300/12.5IRBESARTAN/HYDROCHLOROTHIAZIDE300MG/12.5MGDAR AI DAWA-NA UR PLANT,AMMAN,JORDAN JORDANORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET STRIP01/07/2013
1334NDA/MAL/HDP/5093DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDGAMA PHARMACEUTICALS (U) LIMITEDLIPODAR 10ATORVASTATIN10MGDAR AI DAWA-NA UR PLANT,AMMAN,JORDAN JORDANORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2011
1335NDA/MAL/HDP/5350DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDGAMA PHARMACEUTICALS (U) LIMITEDCEPHADAR FORTECEPHALEXIN250MG/5MLDAR AI DAWA-NA UR PLANT,AMMAN,JORDAN JORDANORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE01/07/2010
1336NDA/MAL/HDP/5351DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDGAMA PHARMACEUTICALS (U) LIMITEDCEPHADARCEPHALEXIN MONOHYDRATE125MG/5MLDAR AI DAWA-NA UR PLANT,AMMAN,JORDAN JORDANORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE01/07/2009
1337NDA/MAL/HDP/6188DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDGAMA PHARMACEUTICALS (U) LIMITEDGIZLAN 150IRBESARTAN150MGDAR AI DAWA-NA UR PLANT,AMMAN,JORDAN JORDANORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2016
1338NDA/MAL/HDP/8125DAR AL DAWA DEVELOPMENT AND INVESTMENT CO. LTDGAMA PHARMACEUTICALS (U) LIMITEDMATADORLEVOFLOXACIN500MGDAR AL DAWA DEVELOPMENT AND INVESTMENT CO. LTD, -NA’UR PRINCE HASHEM BIN AL-HUSSEIN STREET, AMMAN, JORDAN JORDANORAL SOLID ORDINARY TABLETS1.0X1.0X7.0 TABLET BLISTER01/07/2009
1339NDA/MAL/HDP/4657DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDGAMA PHARMACEUTICALS (U) LIMITEDVOLAR 300MGGABAPENTIN300MGDAR AL DAWA-DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD. NA’UR PRINCE HASHEM BIN AL-HUSSEIN STREET. AMMAN, JORDAN JORDANORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER01/07/2013
1340NDA/MAL/HDP/4660DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDGAMA PHARMACEUTICALS (U) LIMITEDRISDONE 2MGRISPERIDONE2MGDAR AL DAWA-DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD. NA’UR PRINCE HASHEM BIN AL-HUSSEIN STREET. AMMAN, JORDAN JORDANORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X10.0 TABLET BLISTER01/07/2013
1341NDA/MAL/HDP/4663DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDGAMA PHARMACEUTICALS (U) LIMITEDLORATANLORATIDINE5MG/5MLDAR AL DAWA-DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD. NA’UR PRINCE HASHEM BIN AL-HUSSEIN STREET. AMMAN, JORDAN JORDANORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE01/07/2013
1342NDA/MAL/HDP/4669DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDGAMA PHARMACEUTICALS (U) LIMITEDDICLOGESIC 100MG SUPPOSITORIESDICLOFENAC SODIUM.100MGDAR AL DAWA-DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD. NA’UR PRINCE HASHEM BIN AL-HUSSEIN STREET. AMMAN, JORDAN JORDANTOPICAL EXTERNAL ADULT SUPPOSITORIES1.0X5.0 SUPPOSITORY STRIP01/07/2013
1343NDA/MAL/HDP/4675DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDGAMA PHARMACEUTICALS (U) LIMITEDDICLOGESIC RETARD 100DICLOFENAC SODIUM100MGDAR AL DAWA-DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD. NA’UR PRINCE HASHEM BIN AL-HUSSEIN STREET. AMMAN, JORDAN JORDANORAL SOLID ORDINARY CAPSULES1.0X2.0X6.0 CAPSULE BLISTER01/07/2013
1344NDA/MAL/HDP/4704DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDGAMA PHARMACEUTICALS (U) LIMITEDDICLOGESIC 12.5DICLOFENAC SODIUM12.5MGDAR AL DAWA-DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD. NA’UR PRINCE HASHEM BIN AL-HUSSEIN STREET. AMMAN, JORDAN JORDANRECTAL SYSTEMIC SUPPOSITORIES1.0X2.0X5.0 SUPPOSITORY BLISTER01/07/2012
1345NDA/MAL/HDP/4705DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDGAMA PHARMACEUTICALS (U) LIMITEDDICLOGESIC-50DICLOFENAC50MGDAR AL DAWA-DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD. NA’UR PRINCE HASHEM BIN AL-HUSSEIN STREET. AMMAN, JORDAN JORDANRECTAL SYSTEMIC SUPPOSITORIES1.0X2.0X5.0 SUPPOSITORY BLISTER01/07/2012
1346NDA/MAL/HDP/4759DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDGAMA PHARMACEUTICALS (U) LIMITEDCIPRODARCIPROFLOXACIN500MGDAR AL DAWA-DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD. NA’UR PRINCE HASHEM BIN AL-HUSSEIN STREET. AMMAN, JORDAN JORDANORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER01/07/2009
1347NDA/MAL/HDP/4795DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDGAMA PHARMACEUTICALS (U) LIMITEDDAROXIMECEFUROXIME500MGDAR AL DAWA-DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD. NA’UR PRINCE HASHEM BIN AL-HUSSEIN STREET. AMMAN, JORDAN JORDANORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BOTTLE01/07/2010
1348NDA/MAL/HDP/4895DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDGAMA PHARMACEUTICALS (U) LIMITEDCLOMIFERTCLOMIPHENE50MGDAR AL DAWA-DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD. NA’UR PRINCE HASHEM BIN AL-HUSSEIN STREET. AMMAN, JORDAN JORDANORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER01/07/2010
1349NDA/MAL/HDP/4948DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDGAMA PHARMACEUTICALS (U) LIMITEDFORMIT 1000METFORMIN HYDROCHLORIDE1000MGDAR AL DAWA-DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD. NA’UR PRINCE HASHEM BIN AL-HUSSEIN STREET. AMMAN, JORDAN JORDANORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2010
1350NDA/MAL/HDP/4950DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDGAMA PHARMACEUTICALS (U) LIMITEDFORMIT 500METFORMIN500MGDAR AL DAWA-DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD. NA’UR PRINCE HASHEM BIN AL-HUSSEIN STREET. AMMAN, JORDAN JORDANORAL SOLID ORDINARY FILM-COATED TABLETS1.0X5.0X10.0 TABLET BLISTER01/07/2009
1351NDA/MAL/HDP/1618DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDGAMA PHARMACEUTICALS (U) LIMITEDAMOXYDARAMOXYCILLIN TRIHYDRATE125MG/5MLDAR AL DAWA-NA'UR PLANT AMMANJORDANORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE01/07/2009
1352NDA/MAL/HDP/2686DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDGAMA PHARMACEUTICALS (U) LIMITEDAMOXYDAR FORTEAMOXICILLIN TRIHYDRATE250MG/5MLDAR AL DAWA-NA'UR PLANT AMMANJORDANORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE01/07/2009
1353NDA/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 BLISTER01/07/2009
1354NDA/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 BLISTER01/07/2009
1355NDA/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 BOTTLE01/07/2010
1356NDA/MAL/HDP/2129DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDGAMA PHARMACEUTICALS (U) LIMITEDCLAVODARAMOXICILLIN/CLAVULANIC ACID500MG/125MGDAR AL DAWA-NA'UR PLANT AMMANJORDANORAL SOLID ORDINARY TABLETS1.0X2.0X7.0 TABLET BLISTER01/07/2011
1357NDA/MAL/HDP/1792DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDGAMA PHARMACEUTICALS (U) LIMITEDLIPODARATORVASTATIN20MGDAR AL DAWA-NA'UR PLANT AMMANJORDANORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2013
1358NDA/MAL/HDP/3724DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDGAMA PHARMACEUTICALS (U) LIMITEDEPIGABPREGABALIN150MGDAR AL DAWA-NA'UR PLANT AMMANJORDANORAL SOLID ORDINARY CAPSULES1.0X4.0X14.0 CAPSULE BLISTER01/07/2015
1359NDA/MAL/HDP/3897DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDGAMA PHARMACEUTICALS (U) LIMITEDCLAVODARAMOXICILLIN/CLAVULANIC ACID875MG/125MGDAR AL DAWA-NA'UR PLANT AMMANJORDANORAL SOLID ORDINARY TABLETS1.0X2.0X7.0 TABLET BLISTER01/07/2010
1360NDA/MAL/HDP/4666DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDGAMA PHARMACEUTICALS (U) LIMITEDANTIPLEXCLOPIDOGREL BISULFATE30MGDAR AL DAWA-NA'UR PLANT AMMANJORDANORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2013
1361NDA/MAL/HDP/4804DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDGAMA PHARMACEUTICALS (U) LIMITEDCLAVODARAMOXICILLIN + CLAVULANIC200MG + 28MG /5MLDAR AL DAWA-NA'UR PLANT AMMANJORDANORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X70.0 ML BOTTLE01/07/2012
1362NDA/MAL/HDP/5321DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDGAMA PHARMACEUTICALS (U) LIMITEDIBUGESIC COLD & SINUSIBUPROFEN/PSEUDOEPHEDRINE200MG/30MGDAR AL DAWA-NA'UR PLANT AMMANJORDANORAL SOLID ORDINARY GELATIN-COATED TABLETS1.0X2.0X10.0 TABLET BLISTER01/07/2012
1363NDA/MAL/HDP/7520DAWA LIMITEDSUPER MEDIC LTDLEVOXCINLEVOFLOXACIN HEMIHYDRATE750 MGDAWA LIMITED -16633-00620, RUARAKA, BABA DOGO ROAD, NAIROBI KENYAORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER27/11/2019
1364NDA/MAL/HDP/0604DAWA PHARMACEUTICALS LIMITEDSUPER MEDIC LTD-MBARARATRIMOXOLCO-TRIMOXAZOLE480MGDAWA LIMITED -16633-00620, RUARAKA, BABA DOGO ROAD, NAIROBI KENYAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER01/07/1997
1365NDA/MAL/HDP/2297DAWA LIMITEDSUPER MEDIC LTDSABULIN SYRUPSALBUTAMOL SULPHATE2MG/5MLDAWA LIMITED -BABA DOGO RWARAKAKENYAORAL LIQUID ORDINARY SYRUPS1.0X1.0X100.0 ML BOTTLE01/07/2008
1366NDA/MAL/HDP/2387DAWA LIMITEDSUPER MEDIC LTDVERMOUTMEBENDAZOLE100MG/5MLDAWA LIMITED -BABA DOGO RWARAKAKENYAORAL LIQUID ORDINARY SUSPENSIONS1.0X30.0 ML BOTTLE01/07/2010
1367NDA/MAL/HDP/0119DAWA LIMITEDSUPER MEDIC LTDDACOLDCAFFEINE ANHYDROUS+CHLORPHENIRAMINE MALEATE+PARACETAMOL+PSEUDOEPHEDRINE30MG+4MG+400MG+30MGDAWA LIMITED -BABA DOGO RWARAKAKENYAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER01/07/2013
1368NDA/MAL/HDP/0692DAWA LIMITEDSUPER MEDIC LTDDAWACLOX -250CLOXACILLIN SODIUM250MGDAWA LIMITED -BABA DOGO RWARAKAKENYAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER01/07/2015
1369NDA/MAL/HDP/1105DAWA LIMITEDSUPER MEDIC LTDDERMAZINE PLUSSILVER SULPHADIAZINE AND CHLORHEXIDINE GLUCONATE1%W/W / 10.0%W/WDAWA LIMITED -BABA DOGO RWARAKAKENYATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE01/07/2014
1370NDA/MAL/HDP/7439DAWA PHARMACEUTICALS LIMITEDSUPER MEDIC LTDLORVICLORATADINE5MG/5MLDAWA LIMITED-16633-00620, RUARAKA, BABA DOGO ROAD, NAIROBI KENYAORAL LIQUID ORDINARY SYRUPS1.0X60.0 ML BOTTLE28/11/2019
1371NDA/MAL/HDP/7442DAWA LIMITED-SUPER MEDIC LTDNERVILIN NTPREGABALIN + NORTRIPTYLINE HYDROCHLORIDE75MG + 10MGDAWA LIMITED-16633-00620, RUARAKA, BABA DOGO ROAD, NAIROBI KENYAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER28/11/2019
1372NDA/MAL/HDP/7443DAWA LIMITED-SUPER MEDIC LTDGOUTSTAT 40FEBUXOSTAT40MGDAWA LIMITED-16633-00620, RUARAKA, BABA DOGO ROAD, NAIROBI KENYAORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER28/11/2019
1373NDA/MAL/HDP/7445DAWA LIMITED-SUPER MEDIC LTDGOUTSTAT 80FEBUXOSTAT80MGDAWA LIMITED-16633-00620, RUARAKA, BABA DOGO ROAD, NAIROBI KENYAORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER28/11/2019
1374NDA/MAL/HDP/7525DAWA LIMITEDSUPER MEDIC LTDLORVICLORATADINE10 MGDAWA LIMITED-16633-00620, RUARAKA, BABA DOGO ROAD, NAIROBI KENYAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER27/11/2019
1375NDA/MAL/HDP/7587DAWA LIMITEDSUPER MEDIC LTDNERVILIN 75PREGABALIN75 MGDAWA LIMITED-16633-00620, RUARAKA, BABA DOGO ROAD, NAIROBI KENYAORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER27/11/2019
1376NDA/MAL/HDP/1168DAWA LIMITEDSUPER MEDIC LTDDAWA-CORT CREAMHYDROCORTISONE1%W/WDAWA LTD -BABA DOGO ROAD, RUARAKA P.O.BOX 16633-00620, NAIROBI KENYA KENYATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE01/07/2009
1377NDA/MAL/HDP/6689DAWA LIMITEDSUPER MEDIC LTDEFLARONMETRONIDAZOLE200MGDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER01/07/1997
1378NDA/MAL/HDP/7329DAWA LIMITEDSUPER MEDIC LTDACEPAR- MRPARACETAMOL +ACECLOFENAC+CHLORZOXAZONE500 MG+100 MG +375 MGDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X10.0 TABLET BLISTER28/03/2018
1379NDA/MAL/HDP/6686DAWA LIMITEDSUPER MEDIC LTDDAWASOLONEPREDNISOLONE5MGDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER01/07/2010
1380NDA/MAL/HDP/0467DAWA PHARMACEUTICALS LIMITEDSUPER MEDIC LTDCURAMOL PLUSPARACETAMOL/CAFFEINE500MG/60MGDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYAORAL SOLID ORDINARY TABLETS50.0X2.0 TABLET STRIP01/07/1997
1381NDA/MAL/HDP/1015DAWA LIMITEDSUPER MEDIC LTDORACEFCEFALEXIN250MGDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER01/07/2013
1382NDA/MAL/HDP/1082DAWA LIMITEDSUPER MEDIC LTDDACOF PAEDIATRICDIPHENHYDRAMINE HYDROCHLORIDE + SODIUM CITRATE + MENTHOL75MG + 28.5MG + 0.55MGDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE01/07/2013
1383NDA/MAL/HDP/1184DAWA LIMITEDSUPER MEDIC LTDDACOF MUCOLYTICSALBUTAMOL + BROMHEXINE + GUAIPHENESIN + MENTHOL2.0MG + 4.0MG +100MG + 1.0MGDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE01/07/2013
1384NDA/MAL/HDP/1185DAWA LIMITEDSUPER MEDIC LTDDACOF DRYDIPHENHYDRAMINE + DEXTROMETHORPHAN + MENTHOL12.5MG + 6.5MG + 1.10MGDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE01/07/2013
1385NDA/MAL/HDP/1186DAWA LIMITEDSUPER MEDIC LTDDACOF EXPECTORANTDIPHENHYDRAMINE HYDROCHLORIDE + AMMONIUM CHLORIDE + SODIUM CITRATE + MENTHOL14.0MG + 135.0MG + 57.0MG + 1.10MGDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE01/07/2013
1386NDA/MAL/HDP/0320DAWA LIMITEDSUPER MEDIC LTDDAZOLECLOTRIMAZOLE1%W/WDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYATOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE01/07/2013
1387NDA/MAL/HDP/0550DAWA LIMITEDSUPER MEDIC LTDDA-ZEPAMDIAZEPAM5MGDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER01/07/2014
1388NDA/MAL/HDP/0126DAWA LIMITEDSUPER MEDIC LTDWHITFIELD'SBENZOIC ACID + SALICYLIC ACID6.0%W/W +3.0%W/WDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYATOPICAL EXTERNAL OINTMENTS1.0X20.0 G TUBE01/07/2014
1389NDA/MAL/HDP/0124DAWA LIMITEDSUPER MEDIC LTDAMPECINAMPICILLIN TRIHYDRATE125MG/5MLDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE01/07/2015
1390NDA/MAL/HDP/0125DAWA LIMITEDSUPER MEDIC LTDSULPHUR OINTMENTSULPHUR10%W/WDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYATOPICAL EXTERNAL OINTMENTS1.0X20.0 G TUBE01/07/2013
1391NDA/MAL/HDP/0318DAWA LIMITEDSUPER MEDIC LTDSABULINSALBUTAMOL4MGDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2013
1392NDA/MAL/HDP/3466DAWA LIMITEDSUPER MEDIC LTDDAWASECSECNIDAZOLE1GDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYAORAL SOLID ORDINARY TABLETS1.0X2.0 TABLET BLISTER01/07/2015
1393NDA/MAL/HDP/3657DAWA LIMITEDSUPER MEDIC LTDDAWASTINNYSTATIN100000IU/MLDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYAORAL LIQUID ORDINARY SUSPENSIONS1.0X30.0 ML BOTTLE01/07/2009
1394NDA/MAL/HDP/3687DAWA LIMITEDSUPER MEDIC LTDDAWA-PROMPROMETHAZINE HCL5MG/5MLDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYAORAL LIQUID ORDINARY SUSPENSIONS1.0X60.0 ML BOTTLE01/07/2010
1395NDA/MAL/HDP/3966DAWA LIMITEDSUPER MEDIC LTDASCORBIC ACID TABLETSASCORBIC ACID100 MGDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYAORAL SOLID ORDINARY CHEWABLE TABLETS1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER01/07/2008
1396NDA/MAL/HDP/4800DAWA LIMITEDSUPER MEDIC LTDDAWAVITE SYRUPMULTI-INGREDIENTMULTI-INGREDIENTDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE01/07/2009
1397NDA/MAL/HDP/4872DAWA LIMITEDSUPER MEDIC LTDMICLOCIN CREAMMICONAZOLE NITRATE + CLOBETASOL PROPRIONATE + GENTAMICN2%W/W+0.5%W/W+0.1W/WDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE01/07/2013
1398NDA/MAL/HDP/8434DAWA LIMITEDSUPER MEDIC LTDDACINAZOLEMICONAZOLE NITRATE2%W/WDAWA LTD-BABA DOGO ROAD RUARAKAKENYATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE01/07/2009
1399NDA/MAL/HDP/8235DAWA LIMITED-SUPER MEDIC LTDACEPARACECLOFENAC + SERRATIOPEPTIDASE + PARACETAMOL100MG + 15MG + 500MGDAWA LTD-BABA DOGO ROAD RUARAKAKENYAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER01/07/2017
1400NDA/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 BOTTLE01/07/2010
1401NDA/MAL/HDP/1367DAWA LIMITEDSUPER MEDIC LTDACEPARACECLOFENAC + PARACETAMOL100 MG + 500 MGDAWA LTD-BABA DOGO ROAD RUARAKAKENYAORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER01/07/2013
1402NDA/MAL/HDP/1813DAWA LIMITEDSUPER MEDIC LTDMOXAFORTEAMOXICILLIN + FLUCLOXACILLIN125 MG + 125MGDAWA LTD-BABA DOGO ROAD RUARAKAKENYAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE01/07/2014
1403NDA/MAL/HDP/0542DAWA LIMITEDSUPER MEDIC LTDPHENBITALPHENOBARBITAL30MGDAWA LTD-BABA DOGO ROAD RUARAKAKENYAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER01/07/2014
1404NDA/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 BLISTER01/07/2013
1405NDA/MAL/HDP/4104DAWA LIMITEDSUPER MEDIC LTDDAWA-PROMPROMETHAZINE HCL25MGDAWA LTD-BABA DOGO ROAD RUARAKAKENYAORAL SOLID ORDINARY COATED TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER01/07/2009
1406NDA/MAL/HDP/4335DAWA LIMITEDSUPER MEDIC LTDCURAMOL SUSPENSIONPARACETAMOL120MG/5MLDAWA LTD-BABA DOGO ROAD RUARAKAKENYAORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE01/07/2009
1407NDA/MAL/HDP/4629DAWA LIMITEDSUPER MEDIC LTDORACEFCEFALEXIN MONOHYDRATE125MG/5MLDAWA LTD-BABA DOGO ROAD RUARAKAKENYAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE01/07/2015
1408NDA/MAL/HDP/2269DAWA LIMITEDSUPER MEDIC LTDDAWAMOXAMOXYCILLIN TRIHYDRATE125MG/5MLDAWA PHARMACEUTICALS LIMITED-PLOT 7879, BABA DOGO ROAD RUARAKA KENYAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE01/07/1997
1409NDA/MAL/HDP/0221DAWA LIMITEDSUPER MEDIC LTDAMPICLO-DAWAAMPICILLIN + CLOXACILLIN250 MG + 250 MGDAWA PHARMACEUTICALS LIMITED-PLOT 7879, BABA DOGO ROAD RUARAKA KENYAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER01/07/2013
1410NDA/MAL/HDP/0283DAWA LIMITEDSUPER MEDIC LTDAMPICLO-DAWAAMPICILLIN + CLOXACILLIN125 MG + 125 MGDAWA PHARMACEUTICALS LIMITED-PLOT 7879, BABA DOGO ROAD RUARAKA KENYAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE01/07/2013
1411NDA/MAL/HDP/1111DAWA LIMITEDSUPER MEDIC LTDFAST-ACT GELDICLOFENAC DIETHYLAMINE + METHYL SALICYLATE + LINSEED OIL + MENTHOL CRYSTALS1.16%W/W + 10%W/W + 3%W/W + 5%W/WDAWA PHARMACEUTICALS LIMITED-PLOT 7879, BABA DOGO ROAD RUARAKA KENYATOPICAL EXTERNAL GELS AND SOLS1.0X20.0 G TUBE01/07/2013
1412NDA/MAL/HDP/0693DAWA LIMITEDSUPER MEDIC LTDMOXACIL -250AMOXYCILLIN TRIHYDRATE250MGDAWA PHARMACEUTICALS LIMITED-PLOT 7879, BABA DOGO ROAD RUARAKA KENYAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER01/07/2014
1413NDA/MAL/HDP/0139ANGLIAN NUTRITION PRODUCTS COMPANYSUPER MEDIC LTDMOXAFORTEFLUCLOXACILLIN SODIUM + AMOXICILLIN TRIHYDRATE250MG + 250MGDAWA PHARMACEUTICALS LIMITED-PLOT 7879, BABA DOGO ROAD RUARAKA KENYAORAL SOLID ORDINARY CAPSULES1.0X2.0X10.0 CAPSULE BLISTER01/07/2014
1414NDA/MAL/HDP/1109DAWA LIMITEDSUPER MEDIC LTDDAWA-CPMCHLORPHENIRAMINE MALEATE2MG/5MLDAWA PHARMACEUTICALS LIMITED-PLOT 7879, BABA DOGO ROAD RUARAKA KENYAORAL LIQUID ORDINARY SYRUPS1.0X60.0 ML BOTTLE01/07/2014
1415NDA/MAL/HDP/1508DAWA LIMITED-SUPER MEDIC LTDWOMNILALBENDAZOLE200MG/5MLDAWA-PLOT 7879, BABA DOGO ROAD RUARAKA, NAIROBI, KENYA KENYAORAL LIQUID ORDINARY SUSPENSIONS1.0X10.0 ML BOTTLE01/07/2009
1416NDA/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 BOTTLE01/07/2009
1417NDA/MAL/HDP/4534DELOBORIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDLORYTEC 10LORATADINE10MGDELORBIS PHARMACEUTICALS LTD-17 ATHINON STR., ERGATES INDUSTRIAL AREA, 2643 ERGATES, P.O. BOX 28629, 2081 LEFKOSIA, CYPRUS CYPRUSORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER01/07/2007
1418NDA/MAL/HDP/3450DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDTRAMADEX 50TRAMADOL50MGDELORBIS PHARMACEUTICALS LTD-17, ATHINON STREET, ERGATES INDUSTRIAL AREA, 2643 ERGATES P.O. BOX 28629, 2081 LEFKOSIA CYPRUSORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER01/07/2009
1419NDA/MAL/HDP/4524DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDFLUCOZAL 150FLUCONAZOLE150MGDELORBIS PHARMACEUTICALS LTD-17, ATHINON STREET, ERGATES INDUSTRIAL AREA, 2643 ERGATES P.O. BOX 28629, 2081 LEFKOSIA CYPRUSORAL SOLID ORDINARY CAPSULES1.0X1.0 CAPSULE BLISTER01/07/2008
1420NDA/MAL/HDP/4530DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDTREDOL 100ATENOLOL100MGDELORBIS PHARMACEUTICALS LTD-17, ATHINON STREET, ERGATES INDUSTRIAL AREA, 2643 ERGATES P.O. BOX 28629, 2081 LEFKOSIA CYPRUSORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER01/07/2008
1421NDA/MAL/HDP/4531DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDTREDOL 50ATENOLOL50MGDELORBIS PHARMACEUTICALS LTD-17, ATHINON STREET, ERGATES INDUSTRIAL AREA, 2643 ERGATES P.O. BOX 28629, 2081 LEFKOSIA CYPRUSORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER01/07/2008
1422NDA/MAL/HDP/4532DELOBORIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDVIRUCID 400ACICLOVIR400 MGDELORBIS PHARMACEUTICALS LTD-17, ATHINON STREET, ERGATES INDUSTRIAL AREA, 2643 ERGATES P.O. BOX 28629, 2081 LEFKOSIA CYPRUSORAL SOLID ORDINARY OTHER TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2008
1423NDA/MAL/HDP/4540DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDVIPROLOX 500CIPROFLOXACIN500MGDELORBIS PHARMACEUTICALS LTD-17, ATHINON STREET, ERGATES INDUSTRIAL AREA, 2643 ERGATES P.O. BOX 28629, 2081 LEFKOSIA CYPRUSORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X10.0 TABLET BLISTER01/07/2008
1424NDA/MAL/HDP/4542DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDCLERON 500CLARITHROMYCIN500MGDELORBIS PHARMACEUTICALS LTD-17, ATHINON STREET, ERGATES INDUSTRIAL AREA, 2643 ERGATES P.O. BOX 28629, 2081 LEFKOSIA CYPRUSORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X14.0 TABLET BLISTER01/07/2008
1425NDA/MAL/HDP/4636DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDZOLARAM 0.5ALPRAZOLAM0.5MGDELORBIS PHARMACEUTICALS LTD-17, ATHINON STREET, ERGATES INDUSTRIAL AREA, 2643 ERGATES P.O. BOX 28629, 2081 LEFKOSIA CYPRUSORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2009
1426NDA/MAL/HDP/4887DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDFLUCOZALFLUCONAZOLE200MGDELORBIS PHARMACEUTICALS LTD-17, ATHINON STREET, ERGATES INDUSTRIAL AREA, 2643 ERGATES P.O. BOX 28629, 2081 LEFKOSIA CYPRUSORAL SOLID ORDINARY CAPSULES1.0X10.0 CAPSULE BLISTER01/07/1997
1427NDA/MAL/HDP/4889DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDFLUCOZALFLUCONAZOLE50MGDELORBIS PHARMACEUTICALS LTD-17, ATHINON STREET, ERGATES INDUSTRIAL AREA, 2643 ERGATES P.O. BOX 28629, 2081 LEFKOSIA CYPRUSORAL SOLID ORDINARY CAPSULES1.0X14.0 CAPSULE BLISTER01/07/1999
1428NDA/MAL/HDP/4890DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDFLUCOZALFLUCONAZOLE100MGDELORBIS PHARMACEUTICALS LTD-17, ATHINON STREET, ERGATES INDUSTRIAL AREA, 2643 ERGATES P.O. BOX 28629, 2081 LEFKOSIA CYPRUSORAL SOLID ORDINARY CAPSULES1.0X10.0 CAPSULE BLISTER01/07/1997
1429NDA/MAL/HDP/5007DELOBORIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDVIRUCIDACYCLOVIR200MGDELORBIS PHARMACEUTICALS LTD-17, ATHINON STREET, ERGATES INDUSTRIAL AREA, 2643 ERGATES P.O. BOX 28629, 2081 LEFKOSIA CYPRUSORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X25.0 TABLET CONTAINER01/07/1997
1430NDA/MAL/HDP/4743DAFRA PHARMA N.V/S.ALABOREX UGANDA LIMITEDMERONIA 1000MEROPENEM1000MGDEMO SA-21ST KM NATIONAL ROAD, ATHENS, LAMIA 14568 KRYONERI, ATHENS GREECEPARENTERAL ORDINARY VIALS1.0X1000.0 MG VIAL01/07/2013
1431NDA/MAL/HDP/4744DAFRA PHARMA N.V/S.ALABOREX UGANDA LIMITEDMERONIA 500MEROPENEM500MGDEMO SA-21ST KM NATIONAL ROAD, ATHENS, LAMIA 14568 KRYONERI, ATHENS GREECEPARENTERAL ORDINARY DRY VIALS1.0X500.0 MG VIAL01/07/2013
1432NDA/MAL/HDP/4315DENK PHARMA GMB H &CO. KGBENLE CONSULT LIMITEDDESLORA-DENK 5DESLORATIDINE5MGDENK PHARMA GMBH & CO.KG -GOLLSTR 1,84529 TITTMONING GERMANY GERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER01/07/2016
1433NDA/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 BLISTER01/07/2005
1434NDA/MAL/HDP/4334DENK PHARM GMBH&CO.KGBENLE CONSULT LIMITEDLOSAR-DENK 50LOSARTAN50MGDENK PHARMA GMBH & CO.-PRINZREGENTENSTR. 79, 81675 MÜNCHEN, GÖLLSTR. 1, 84529 TITTMONING, GERMANY GERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X14.0 TABLET BLISTER01/07/2011
1435NDA/MAL/HDP/4634DENK PHARMA GMB H &CO. KGBENLE CONSULT LIMITEDLOSAR-DENK 100LOSARTAN100MGDENK PHARMA GMBH & CO.-PRINZREGENTENSTR. 79, 81675 MÜNCHEN, GÖLLSTR. 1, 84529 TITTMONING, GERMANY GERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X14.0 TABLET BLISTER01/07/2011
1436NDA/MAL/HDP/3583DENK PHARMA GMBH & COBENLE CONSULT LIMITEDSIMVA-DENK 40SIMVASTATIN40MGDENK PHARMA GMBH & CO-G0 11 STR.1 84529 T,HMONING GERMANY GERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2011
1437NDA/MAL/HDP/8095DENK PHARMA GMB H &CO. KGBENLE CONSULT LIMITEDCOLOSAR-DENK 100/12.5LOSARTAN POTASSIUM + HYDROCHLOROTHIAZIDE100MG + 12.5MGDENK PHARMA GMBH &CO.KG--PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANY GERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X14.0 TABLET BLISTER01/07/2016
1438NDA/MAL/HDP/2525ERIS LTDBENLE 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 BLISTER01/07/1998
1439NDA/MAL/HDP/2647DENK PHARMABENLE 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 BLISTER01/07/2005
1440NDA/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 BLISTER01/07/2007
1441NDA/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 BLISTER01/07/2014
1442NDA/MAL/HDP/0754DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDTORAS DENK 10TORASEMIDE10MGDENK PHARMA GMBH &CO.KG--PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANY GERMANYORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2015
1443NDA/MAL/HDP/3631DENK PHARMA GMBH & CO KGBENLE CONSULT LIMITEDENA-DENK 10ENALAPRIL MALEATE10MGDENK PHARMA GMBH &CO.KG--PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANY GERMANYORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER01/07/2008
1444NDA/MAL/HDP/3728ERIS LTDBENLE CONSULT LIMITEDDICLO-DENK 50DICLOFENAC SODIUM50MGDENK PHARMA GMBH &CO.KG--PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANY GERMANYORAL SOLID ORDINARY FILM-COATED TABLETS10.0X10.0 TABLET BLISTER + 1 * 10 SAMPLE01/07/1998
1445NDA/MAL/HDP/4317DENK PHARMA GMB H &CO. KGBENLE CONSULT LIMITEDCOLOSAR-DENK 50/12.5LOSARTAN + HYDROCHLOROTHIAZIDE50MG + 12.5MGDENK PHARMA GMBH &CO.KG--PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANY GERMANYORAL SOLID ORDINARY TABLETS1.0X1.0X14.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER01/07/2011
1446NDA/MAL/HDP/4757ERIS LTDBENLE CONSULT LIMITEDMETFORMIN-DENK 500METFORMIN500MGDENK PHARMA GMBH &CO.KG--PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANY GERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER01/07/1998
1447NDA/MAL/HDP/4758DENK PHARMA GMB H &CO. KGBENLE CONSULT LIMITEDMETFORMIN DENK 1000METFORMIN1000MGDENK PHARMA GMBH &CO.KG--PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANY GERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X15.0 TABLET BLISTER01/07/2011
1448NDA/MAL/HDP/2296ERIS LTDBENLE CONSULT LIMITEDRANI-DENK 150RANITIDINE150MGDENK PHARMA GMBH &CO.KG-PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 GERMANYORAL SOLID ORDINARY TABLETS1.0X20.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER,1.0X50.0 TABLET CONTAINER01/07/2000
1449NDA/MAL/HDP/4147ERIS LTDBENLE CONSULT LIMITEDNIFEDI-DENK 20 RETARDNIFEDIPINE20MGDENK PHARMA GMBH &CO.KG-PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 GERMANYORAL SOLID RETARD FILM-COATED TABLETS1.0X10.0X10.0 TABLET STRIP01/07/2000
1450NDA/MAL/HDP/2746ERIS LTDBENLE 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 BLISTER01/07/2000
1451NDA/MAL/HDP/5392DENK PHARMA GMB H &CO. KGBENLE CONSULT LIMITEDAMLO-DENK 10AMLODIPINE MESILATE MONOHYDRATE10MGDENK PHARMA GMBH &CO.KG-PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANY GERMANYORAL SOLID ORDINARY TABLETS1.0X5.0X10.0 TABLET BLISTER01/07/2008
1452NDA/MAL/HDP/5393DENK PHARMA GMB H &CO. KGBENLE CONSULT LIMITEDAMLO-DENK 5AMLODIPINE MESILATE MONOHYDRATE5MGDENK PHARMA GMBH &CO.KG-PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANY GERMANYORAL SOLID ORDINARY TABLETS1.0X5.0X10.0 TABLET BLISTER01/07/2008
1453NDA/MAL/HDP/2429ERIS LTDBENLE 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 CARTON01/07/1998
1454NDA/MAL/HDP/3197ERIS LTDBENLE CONSULT LIMITEDTRIAM-DENK 40 INJECTION TRIAMCINOLONE ACETONIDE40 MG/MLDENK PHARMA, GOLLSTR.,-1-D-845 529 TITTMONING GERMANY
GERMANYPARENTERAL ORDINARY AMPOULES1.0X10.0X1.0 ML AMPOULE01/07/2004
1455NDA/MAL/HDP/3619ERIS LTDBENLE CONSULT LIMITEDCAPTOPRIL DENK -25CAPTOPRIL25MGDENK PHARMA, GOLLSTR.,-1-D-845 529 TITTMONING GERMANY
GERMANYORAL SOLID ORDINARY TABLETS10.0X10.0 TABLET BLISTER,2.0X10.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER01/07/2000
1456NDA/MAL/HDP/6495DAFRA PHARMA GMBHLABOREX UGANDA LIMITEDMACROLYN® 500 MG FILM COATED TABLETSAZITHROMYCIN DIHYDRATE500MGDEVA HOLDING A. S.-ÇERKEZKÖY ORGANIZE SANAYI BOLGESI. KARAA?AÇ MAH. ATATÜRK CAD. NO: 32 KAPAKLI- TEKIRDA?/ TURKEYTURKEYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X3.0 TABLET BLISTER29/11/2017
1457NDA/MAL/HDP/8130DEVA HOLDING A.SSHREEJI PHARMACEUTICALS LIMITEDDEGRA 100SILDENAFIL CITRATE100MGDEVA HOLDING A. S.-ÇERKEZKÖY ORGANIZE SANAYI BOLGESI. KARAA?AÇ MAH. ATATÜRK CAD. NO: 32 KAPAKLI- TEKIRDA?/ TURKEYTURKEYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X4.0 TABLET BLISTER30/05/2018
1458NDA/MAL/HDP/8131DEVA HOLDING A.SSHREEJI PHARMACEUTICALS LIMITEDDEGRASILDENAFIL CITRATE50MGDEVA HOLDING A. S.-ÇERKEZKÖY ORGANIZE SANAYI BOLGESI. KARAA?AÇ MAH. ATATÜRK CAD. NO: 32 KAPAKLI- TEKIRDA?/ TURKEYTURKEYORAL SOLID ORDINARY TABLETS1.0X4.0 TABLET BLISTER01/07/2017
1459NDA/MAL/HDP/8226DEVA HOLDING A.SSHREEJI PHARMACEUTICALS LIMITEDSALRES