Drug Register (November 2018)
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 SIZE
1NDA/MAL/HHP/3115SHURIK LTDSHURIK LTDRHINO BALMMEHTA UNANI PHARMACY & CO LTD-INDIAINDIATOPICAL EXTERNAL OINTMENTS1.0X20.0 G CONTAINER,1.0X10.0 G CONTAINER
2NDA/MAL/HHP/5498AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDFIGURINAJANTA PHARMA LTD 31-0-AJANTA PHARMA LTD 31-0 MIDC INDUSTRIAL AREACHIKALTHANA 431210 DIST AURANGABAD MAHARASHTRAINDIAORAL SOLID ORDINARY CAPSULES1.0X6.0X10.0 CAPSULE BLISTER
3NDA/MAL/HHP/5503ABACUS PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDAMODEX OINTMENTPOOJA DRUGS-POOJA DRUGSINDIATOPICAL EXTERNAL OINTMENTS1.0X25.0 G JAR
4NDA/MAL/HHP/5505VENUS REMIDIES LTDHARLEYS UGANDA LIMITEDAMPUCARE HERBAL OILPLANET HERBS LIFESCIENCES LIMITED -B-4 SARA INDUSTRIAL ESTATE, SELAQUI, DEHRADUN-248197, UTTARKHAND, INDIAINDIATOPICAL EXTERNAL LIQUIDS1.0X50.0 ML BOTTLE
5NDA/MAL/HHP/5506MONA LABVRUSHIK INVESTMENT LIMITEDSTOPAIN ROLL ONMONA LAB-20/2 CHAMPSI BHIMJI ROAD, THAKKAR IND. ESTATE UNIT 2, 2ND FLOOR, MAZGOAN MUMBAI-400010INDIAORAL LIQUID ORDINARY LIQUIDS1.0X6.0 ML BOTTLE
6NDA/MAL/HHP/5516MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDANCARE CAPSULESVITAL CARE PVT LTD-361-362 GIDC POR
RAMAGANDI VADODARA
INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER
7NDA/MAL/HHP/5518MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDPENODEX OINTMENTMEHTA UNANI PHARMACY & CO LTD-INDIAINDIATOPICAL EXTERNAL OINTMENTS1.0X20.0 G CONTAINER
8NDA/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 AURANGABADINDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE
9NDA/MAL/HHP/5528VIRCHOW HEALTHCARE PVT LTDSURGIPHARM (U) LIMITEDAQUAREST288,SIDCO ESTATE-AMBATTUR, CHENNAI 600 098, TAMIL NADU, INDIAINDIAORAL SOLID ORDINARY POWDERS1.0X10.0X765.0 MG SACHET
10NDA/MAL/HHP/5532MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDATMANANTHAN COLD RUBMETA UNANI PHARMACY & CO PVT-G 5524, GIDC, LODHIKA METODA, DIST RAJKOT, GUJARATIINDIANASAL TOPICAL OINTMENTS1.0X12.0 G CONTAINER
11NDA/MAL/HHP/5536ABACUS PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDMENTHO PLUS PAIN BALMEMAMI LTD-EMAMI LIMITED COLLEGE NAGAR ABHOYPUR, GUWAHATI 781031, ASSAM INDIA / EMAMI LIMITED PLOT NO 200 SANJAN -AMAGOAN ROAD DONGARI TALASARIINDIANASAL 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 BOTTLE
12NDA/MAL/HHP/5547SHURIK LTDSHURIK LTDMENTHOSIL COUGH DROPMEHTA HERBALS PVT LTD-INDIAINDIAORAL SOLID ORDINARY LOZENGES1.0X35.0X2.0 LOZENGE STRIP
13NDA/MAL/HHP/5548EMAMI LTDJEET PHARMACEUTICALS LIMITEDHIMANI FAST HERBAL PAIN RELIEF OINTMENTEMAMI LTD-EMAMI LIMITED COLLEGE NAGAR ABHOYPUR, GUWAHATI 781031, ASSAM INDIA / EMAMI LIMITED PLOT NO 200 SANJAN -AMAGOAN ROAD DONGARI TALASARIINDIATOPICAL EXTERNAL OINTMENTS1.0X4.0 ML BOTTLE,1.0X25.0 ML BOTTLE,1.0X50.0 ML BOTTLE,1.0X12.0 ML BOTTLE
14NDA/MAL/HHP/5551EMAMI LTDJEET PHARMACEUTICALS LIMITEDHIMANI FAST HERBAL PAIN BALMEMAMI LTD-EMAMI LIMITED COLLEGE NAGAR ABHOYPUR, GUWAHATI 781031, ASSAM INDIA / EMAMI LIMITED PLOT NO 200 SANJAN -AMAGOAN ROAD DONGARI TALASARIINDIATOPICAL EXTERNAL OINTMENTS1.0X25.0 ML BOTTLE
15NDA/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 STRIP
16NDA/MAL/HHP/5554EMAMI LTDJEET PHARMACEUTICALS LIMITEDHIMANI FIRST HERBAL PAIN RELIF SPRAYEMAMI LTD-EMAMI LIMITED COLLEGE NAGAR ABHOYPUR, GUWAHATI 781031, ASSAM INDIA / EMAMI LIMITED PLOT NO 200 SANJAN -AMAGOAN ROAD DONGARI TALASARIINDIATOPICAL EXTERNAL PRESSURISED AEROSOLS1.0X150.0 ML CANNISTER
17NDA/MAL/HHP/5556SHURIK LTDSHURIK LTDCOLD RUB VAPORIZINGMETHA UNANI PHARMACY-INDIAINDIANASAL TOPICAL EMULSION OINTMENTS1.0X5.0 G CONTAINER,1.0X9.0 G CONTAINER,1.0X10.0 G CONTAINER
18NDA/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,KENYAINDIAORAL LIQUID ORDINARY LIQUIDS1.0X120.0 ML BOTTLE,1.0X100.0 ML BOTTLE
19NDA/MAL/HHP/5558EMAMI LTDJEET PHARMACEUTICALS LIMITEDHIMANI FIRST HERBAL VAPOUR RUBEMAMI LTD-EMAMI LIMITED COLLEGE NAGAR ABHOYPUR, GUWAHATI 781031, ASSAM INDIA / EMAMI LIMITED PLOT NO 200 SANJAN -AMAGOAN ROAD DONGARI TALASARIINDIATOPICAL EXTERNAL OTHER OINTMENTS1.0X25.0 ML JAR
20NDA/MAL/HHP/5559SHURIK LTDSHURIK LTDSTAR SKIN OINTMENTMEHTA UNANI PHARMACY & CO LTD-INDIAINDIATOPICAL EXTERNAL OINTMENTS1.0X12.0 G TUBE
21NDA/MAL/HHP/5560AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDSTAMINAAJANTA PHARMA LTD-31-0, M.I.D.C. CHIKALTHANA, CHIKALTHANA, AURANGABAD, MAHARASHTRA STATE, INDIAINDIAORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER
22NDA/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, INDIAINDIAORAL SOLID ORDINARY LOZENGES1.0X1.0X100.0 LOZENGE CARTON
23NDA/MAL/HHP/5564AIL HEALTH CAREVRUSHIK INVESTMENT LIMITEDFRESH HERBAL COUGH SYRUPAIL HEALTH CARE-816/1 RAKANPUR KALOL GENDHINAGAR GUJRATINDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE
24NDA/MAL/HHP/5565ABACUS PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDDENTEX TOOTHACEPOOJA DRUGS-POOJA DRUGSINDIATOPICAL EXTERNAL LIQUIDS1.0X5.0 ML BOTTLE
25NDA/MAL/HHP/5570PANACEA BIOTEC LTDABACUS PHARMA (AFRICA) LIMITEDSITCOMPANACEA BIOTEC LTD--MALPUR, BADDI, TEHSIL, NALAGARH, DIST. SOLAN HIMACHAL PRADESH – 173 205INDIAORAL SOLID ORDINARY TABLETS1.0X2.0X7.0 TABLET BLISTER
26NDA/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, INDIAINDIATOPICAL EXTERNAL OTHER OINTMENTS1.0X10.0 ML CONTAINER,1.0X5.0 ML CONTAINER
27NDA/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 BOTTLE
28NDA/MAL/HHP/5576SHURIK LTDSHURIK LTDNO SCAR CREAMMETHA UNANI PHARMACY-METHA UNANI PHARMACY G-524 LODHIKA, G.I.D.C METODAINDIATOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE
29NDA/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 BOTTLE
30NDA/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 BOTTLE
31NDA/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 INDIAINDIAORAL TOPICAL DROPS1.0X10.0 ML BOTTLE
32NDA/MAL/HHP/5613ANDYCO PHARMACYANDYCO PHARMACY (UGANDA) LTDSMOOTH COUGH DROPSDR KIM AYURVEDIC PHARMACY-INDIAINDIAORAL SOLID ORDINARY LOZENGES1.0X100.0X2.0 LOZENGE STRIP
33NDA/MAL/HHP/5618SHURIK LTDSHURIK LTDVYBRANTVITAL CARE-INDIAINDIAORAL SOLID ORDINARY CAPSULES5.0X10.0 CAPSULE BLISTER
34NDA/MAL/HHP/5620UNIQUE PHARMACEUTICAL LABORATORIESTATA UGANDA LIMITEDZECUF COLD RUBUNIQUE PHARMACEUTICAL LABORATORIES-PLOT NO. 4 PASE IV, GIDC PANOLI -394 116
GUJARAT INDIA
INDIATOPICAL EXTERNAL OINTMENTS1.0X20.0 G CONTAINER
35NDA/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 INDIAINDIAORAL SOLID ORDINARY LOZENGES1.0X5.0X4.0 LOZENGE STRIP
36NDA/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 INDIAINDIAORAL SOLID ORDINARY LOZENGES1.0X5.0X4.0 LOZENGE STRIP
37NDA/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 BOTTLE
38NDA/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 INDIAINDIAORAL SOLID ORDINARY LOZENGES1.0X5.0X4.0 LOZENGE STRIP
39NDA/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, INDIAINDIAORAL SOLID ORDINARY LOZENGES1.0X5.0X4.0 LOZENGE BLISTER,1.0X10.0X6.0 LOZENGE BLISTER
40NDA/MAL/HHP/7929WOCKHARD LTDSTAR PHARMACEUTICALS LTDMANIX HERBAL CAPSULESTIRUPATI LIFESCIENCES-NAHAN ROAD, PAONTA SAHIB, DISTT. SIRMOUR HIMACHAL PRADESH-173025, INDIAINDIAORAL SOLID ORDINARY CAPSULES1.0X2.0X10.0 CAPSULE BLISTER
41NDA/MAL/HHP/7931DAR AL DAWA DEVELOPMENT AND INVESTMENT CO. LTDKIMSY MEDS LTDLIBLAB 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 BOTTLE
42NDA/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 BLISTER
43NDA/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 INDIAINDIAORAL SOLID ORDINARY LOZENGES1.0X5.0X4.0 LOZENGE STRIP
44NDA/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 CONTAINER
45NDA/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 INDIAINDIAORAL SOLID ORDINARY LOZENGES1.0X5.0X4.0 LOZENGE STRIP
46NDA/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 INDIAINDIAORAL SOLID ORDINARY LOZENGES1.0X5.0X4.0 LOZENGE STRIP
47NDA/MAL/HHP/7955KREMOINT PHARMA PVT.LTDGOOD DAY PHARMACY LIMITEDDICLODAY ROLL-ONKREMOINT PHARMA PVT LTD-B-8,ADDITIONAL AMBERNATH MIDC, AMBERNATH (E),DIST: THANE 421506, INDIA INDIATOPICAL EXTERNAL EMULSIONS1.0X50.0 ML BOTTLE
48NDA/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 INDIAINDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE
49NDA/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, INDIAINDIAORAL SOLID ORDINARY LOZENGES1.0X5.0X4.0 LOZENGE BLISTER,1.0X10.0X6.0 LOZENGE BLISTER
50NDA/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, INDIAINDIAORAL SOLID ORDINARY LOZENGES1.0X5.0X4.0 LOZENGE BLISTER,1.0X10.0X6.0 LOZENGE BLISTER
51NDA/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, INDIAINDIAORAL SOLID ORDINARY LOZENGES1.0X5.0X4.0 LOZENGE BLISTER,1.0X10.0X6.0 LOZENGE BLISTER
52NDA/MAL/HHP/7962GOODDAY P HARMACYL IMITEDGOOD DAY PHARMACY LIMITEDKREMOINT BABY CARE GRIPE WATERKREMOINT PHARMA PVT LTD---B-8 ADDITIONAL AMBERNATH MIDC OPP. ANAND NAGAR POLICE CHECK POST AMBERNATH (E) DIST THANE 421 506INDIAORAL LIQUID ORDINARY LIQUIDS1.0X135.0 ML BOTTLE
53NDA/MAL/HHP/7972MONA LABVRUSHIK INVESTMENT LIMITEDSTOPAIN BALMMONA LAB-20/2 CHAMPSI BHIMJI ROAD, THAKKAR IND. ESTATE UNIT 2, 2ND FLOOR, MAZGOAN MUMBAI-400010INDIATOPICAL EXTERNAL OINTMENTS1.0X9.0 G JAR,1.0X5.0 G CONTAINER
54NDA/MAL/HHP/7975MONA LABVRUSHIK INVESTMENT LIMITEDSTOPAIN INHALERMONA LAB-20/2 CHAMPSI BHIMJI ROAD, THAKKAR IND. ESTATE UNIT 2, 2ND FLOOR, MAZGOAN MUMBAI-400010INDIANASAL SYSTEMIC UNIT DOSE AEROSOLS1.0X1.0 CARTON CONTAINER
55NDA/MAL/HHP/8070LEXINE TECHNOCHEM PVT LTDMUKWANO PHARMACEUTICALS LIMITEDKWIK PAIN RELIEVING CREAMLEXINE TECHNOCHEM PVT LTD.-INDIAINDIATOPICAL EXTERNAL CREAMS1.0X30.0 G TUBE
56NDA/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, EGYPTEGYPTTOPICAL EXTERNAL LOTIONS1.0X1.0X40.0 G TUBE
57NDA/MAL/HHP/8215AMRUTANJAN HEALTH CARE LTDABACUS PHARMA (A) LTD - WILSON LANEAMRUTANJAN DRAGON BACK PAIN ROLL-ONAMRUTANJAN HEALTH CARE LIMITED - -PLOT NO.14, INDUSTRIAL DEVELOPMENT AREA, UPPAL HYDERABAD - 500039, INDIA INDIATOPICAL EXTERNAL LOTIONS1.0X50.0 ML CONTAINER
58NDA/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 BOTTLE
59NDA/MAL/HHP/8289HIMALAYA DRUG COMPANYMETAPLUS (U) LIMITEDGERIFORTEHIMALAYA DRUG COMPANY-27256287 INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X100.0 TABLET CONTAINER
60NDA/MAL/HHP/8379CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDM2 TONE TABLET CHARAK PHARMA PVT LTD-INDUSTRIALESTATE, SHAUTI MILL LANE, MUMBAI-400011INDIAORAL SOLID ORDINARY TABLETS1.0X60.0 TABLET BOTTLE
61NDA/MAL/HHP/8385GULF PHARMACEUTICAL INDUSTRIES(JULPHAR).GAMA PHARMACEUTICALS (U) LIMITEDMEBOSCAR OINTMENTGULF PHARMACEUTICAL INDUSTRIES (JULPHAR)-AIRPORT ROAD,
DIGDAGA STREET
RAS AL KHAIMAH
UNITED ARAB EMIRATESTOPICAL EXTERNAL OINTMENTS1.0X30.0 G TUBE
62NDA/MAL/HHP/8505CHARAK PHARMA PVT LTDABACUS PHARMA (A) LTD - WILSON LANELIVOMYN SYRUP CHARAK PHARMA PVT LTD-INDUSTRIALESTATE, SHAUTI MILL LANE, MUMBAI-400011INDIAORAL LIQUID ORDINARY LIQUIDS1.0X200.0 ML BOTTLE
63NDA/MAL/HHP/8506CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDALKA 5 SYRUP CHARAK PHARMA PVT LTD-INDUSTRIALESTATE, SHAUTI MILL LANE, MUMBAI-400011INDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE
64NDA/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 BLISTER
65NDA/MAL/HHP/8508CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDKOFOL SF SYRUP CHARAK PHARMA PVT LTD-INDUSTRIALESTATE, SHAUTI MILL LANE, MUMBAI-400011INDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE
66NDA/MAL/HHP/8509CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDEVANOVA CAPSULE CHARAK PHARMA PVT LTD-INDUSTRIALESTATE, SHAUTI MILL LANE, MUMBAI-400011INDIAORAL SOLID ORDINARY CAPSULES1.0X20.0 CAPSULE BLISTER
67NDA/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 BOTTLE
68NDA/MAL/HHP/8548ARTURA PHARMACEUTICALS PVT LTDMEDVIN PHARMA LIMITEDPEPSOLARTURA PHARMACEUTICALS PVT LTD-PLOT NO. 1505 PORTIA ROAD SIRI CITY SEZ SATYAVEDU MANDAL CHITTOOR DISTRICT ANDHRA PRADESHI - 517 588 INDIAINDIAORAL SOLID ORDINARY OTHER CAPSULES1.0X3.0X10.0 CAPSULE BLISTER
69NDA/MAL/HHP/8549UNOSOURCE PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDUNOSOYMAXCURE NUTRVEDIC LTD-PLOT NO. 13, SECTOR 6-A,INTEGRATED INDUSTRIAL ESTATE(IIE), SIDCUL
HARIDWAR-249403 UTTARAKHAND
INDIAORAL SOLID ORDINARY OTHER CAPSULES1.0X60.0 CAPSULE BOTTLE
70NDA/MAL/HHP/8550UNOSOURCE PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDUNOCALMMAXCURE NUTRVEDIC LTD-PLOT NO. 13, SECTOR 6-A,INTEGRATED INDUSTRIAL ESTATE(IIE), SIDCUL
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INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X60.0 TABLET BOTTLE
71NDA/MAL/HHP/8551AMRUTANJAN HEALTHCARE LIMITEABACUS PHARMA (AFRICA) LIMITEDAMRUTANJAN RELIEF COUGH AND COLD SYRUPAMRUTANJAN HEALTH CARE LIMITED -PLOT NO.14, INDUSTRIAL DEVELOPMENT AREA, UPPAL HYDERABAD - 500039, INDIA
PLOT NO.:37, 38 & 39, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR VILLAGE, THIRUPORUR TK,
KANCHEEPURAM, DIST. – 603 110, TAMILNADU, INDIA
INDIAORAL LIQUID ORDINARY UNIT DOSE LIQUIDS1.0X8.0 ML SACHET
72NDA/MAL/HHP/8552AMRUTANJAN HEALTHCARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDAMRUTANJAN DRAGON BALMAMRUTANJAN HEALTH CARE LIMITED -PLOT NO.14, INDUSTRIAL DEVELOPMENT AREA, UPPAL HYDERABAD - 500039, INDIA
PLOT NO.:37, 38 & 39, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR VILLAGE, THIRUPORUR TK,
KANCHEEPURAM, DIST. – 603 110, TAMILNADU, INDIA
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73NDA/MAL/HHP/8553RAZA INTERNATIONALWIDE SPECTRUM ENTERPRISES (U) LIMITEDHONEY CUREOZONE COSMETICS & NATURAL PRODUCTS MANUFACTURING COMPANY?-SHARA BADRAN, MARJ ALFARAS, INDUSTRIAL ZONE, MUSAWAA STREET.
OZONE INDUSTRIAL COMPLEX. P.O. BOX : 1764. AMMAN 11953, JORDAN
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74NDA/MAL/HHP/8554OVIANI PHARMACHEM PVT. LTDMUKWANO PHARMACEUTICALS LIMITEDDIGLOCISHA AGRO DEVELOPERS PVT.LTD-36A/55AB, LONAVALA CO.OP.INDL.EST.LTD,
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INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X60.0 TABLET BOTTLE
75NDA/MAL/HHP/8555MUSANA PHARMACEUTICALS LIMITEDMUSANA PHARMACEUTICALS LTDNATURAL AIDNIXON BIOTECH PRIVATE LIMITED-PLOT NO. 861 INDUSTRIAL AREA-4 LUDHIANA-3(PUNJAB) INDIAINDIAORAL SOLID ORDINARY OTHER CAPSULES1.0X30.0 CAPSULE BOTTLE
76NDA/MAL/HHP/8556MANKIND PHARMA LTD.TATA UGANDA LIMITEDUNIORTHO-500TIRUPATI LIFESCIENCES-NAHAN ROAD, PAONTA SAHIB, DISTT. SIRMOUR HIMACHAL PRADESH-173025, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER
77NDA/MAL/HHP/8557MANKIND PHARMA LTD.TATA UGANDA LIMITEDUNIORTHO-250TIRUPATI LIFESCIENCES-NAHAN ROAD, PAONTA SAHIB, DISTT. SIRMOUR HIMACHAL PRADESH-173025, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER
78NDA/MAL/HHP/8672OVIANI PHARMACHEM PVT. LTDMUKWANO PHARMACEUTICALS LIMITEDHYARTHO CAPSULESISHA AGRO DEVELOPERS PVT.LTD-36A/55AB, LONAVALA CO.OP.INDL.EST.LTD,
VILLAGE-NANGARGAON, LONAVALA,TALUKA-MAVAL,DIST. PUNE 410401 MAHARASHTRA INDIA
INDIAORAL SOLID ORDINARY OTHER CAPSULES1.0X60.0 CAPSULE BOTTLE
79NDA/MAL/HHP/8673OVIANI PHARMACHEM PVT. LTDMUKWANO PHARMACEUTICALS LIMITEDCALMLA CAPSULEISHA AGRO DEVELOPERS PVT.LTD-36A/55AB, LONAVALA CO.OP.INDL.EST.LTD,
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INDIAORAL SOLID ORDINARY OTHER CAPSULES1.0X60.0 CAPSULE BOTTLE
80NDA/MAL/HHP/8674OVIANI PHARMACHEM PVT. LTDMUKWANO PHARMACEUTICALS LIMITEDPYLKER TABLETSISHA AGRO DEVELOPERS PVT.LTD-36A/55AB, LONAVALA CO.OP.INDL.EST.LTD,
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INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X60.0 TABLET BOTTLE
81NDA/MAL/HHP/8675OVIANI PHARMACHEM PVT. LTDMUKWANO PHARMACEUTICALS LIMITEDDIBCARE TABLETSISHA AGRO DEVELOPERS PVT.LTD-36A/55AB, LONAVALA CO.OP.INDL.EST.LTD,
VILLAGE-NANGARGAON, LONAVALA,TALUKA-MAVAL,DIST. PUNE 410401 MAHARASHTRA INDIA
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X60.0 TABLET BOTTLE
82NDA/MAL/HHP/8676OVIANI PHARMACHEM PVT. LTDMUKWANO PHARMACEUTICALS LIMITEDSUTRIM TABLETSISHA AGRO DEVELOPERS PVT.LTD-36A/55AB, LONAVALA CO.OP.INDL.EST.LTD,
VILLAGE-NANGARGAON, LONAVALA,TALUKA-MAVAL,DIST. PUNE 410401 MAHARASHTRA INDIA
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X60.0 TABLET BOTTLE
83NDA/MAL/HHP/8837PILLAR PHARMA LIMITEDPILLAR LOGISTICS LIMITEDHEPTOVITMILENNIUM HERBAL CARE LTD-12B, NIRMAL, 241/242, BACKBAY RECLAMATION, NARIMAN POINT, MUMBAI 400 021INDIAORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER
84NDA/MAL/HHP/8840UNOSOURCE PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDOBECONMAXCURE NUTRVEDIC LTD-PLOT NO. 13, SECTOR 6-A,INTEGRATED INDUSTRIAL ESTATE(IIE), SIDCUL
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INDIAORAL SOLID ORDINARY CAPSULES1.0X60.0 CAPSULE BOTTLE
85NDA/MAL/HHP/8841DEWYX INTERNATIONAL LTDDEWYX PHARMACEUTICALS LIMITEDM-ENERGEX CAPSULESBIO GALLERY-SDN BHDMALAYSIAORAL SOLID ORDINARY CAPSULES1.0X50.0X1.0 CAPSULE BLISTER,1.0X25.0X1.0 CAPSULE BLISTER
86NDA/MAL/HHP/8842DEWYX INTERNATIONAL LTDDEWYX PHARMACEUTICALS LIMITEDM-ENERGEX COFFEEBIO GALLERY-SDN BHDMALAYSIAORAL SOLID ORDINARY POWDERS1.0X10.0X20.0 G SACHET
87NDA/MAL/HHP/8892NANO BIOPHARMA LIMITEDUNEED GLOBAL GROUP LIMITEDANGIPARSNANO HAYAT DAROU (NANO BIOPHARMA)-NO.168/2 16TH NOAVARI STREET, PARDIS TECHNOLOGY PARK-PARDIS-TEHRAN-IRANIRANTOPICAL EXTERNAL OINTMENTS1.0X30.0 G TUBE
88NDA/MAL/HHP/8893NANO BIOPHARMA LIMITEDUNEED GLOBAL GROUP LIMITEDANGIPARSNANO HAYAT DAROU (NANO BIOPHARMA)-NO.168/2 16TH NOAVARI STREET, PARDIS TECHNOLOGY PARK-PARDIS-TEHRAN-IRANIRANORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER
89NDA/MAL/HHP/8899LEXINE TECHNOCHEM PVT LTDMUKWANO PHARMACEUTICALS LIMITEDLEXICOF HERBAL COUGH SYRUPLEXINE TECHNOCHEM PVT LTD -SURVEY PLOT NO. 373,
OPP. RAMAKAKA DERI CHHANI, VADODARA – 391704 GUJARAT, INDIA
INDIAORAL LIQUID ORDINARY SYRUPS1.0X1.0X100.0 ML BOTTLE
90NDA/MAL/HHP/8900UNOSOURCE PHARMA LTD.ABACUS PHARMA (AFRICA) LIMITEDMIGROSTOPUNOSOURCE PHARMA LTD -503/504, HUBTOWN SOLARIS, N.S PHADKE MARG, ANDHERRI EAST, MUMAI 400069 INDIAINDIAORAL SOLID ORDINARY OTHER CAPSULES1.0X60.0 CAPSULE CONTAINER
91NDA/MAL/HHP/8901NANO BIOPHARMA LIMITEDUNEED GLOBAL GROUP LIMITEDANGIPARSNANO HAYAT DAROU (NANO BIOPHARMA)-NO.168/2 16TH NOAVARI STREET, PARDIS TECHNOLOGY PARK-PARDIS-TEHRAN-IRANIRANTOPICAL EXTERNAL PRESSURISED OINTMENTS1.0X30.0 G TUBE
92NDA/MAL/HHP/8902NANO BIOPHARMA LIMITEDUNEED GLOBAL GROUP LIMITEDANGIPARSNANO HAYAT DAROU (NANO BIOPHARMA)-NO.168/2 16TH NOAVARI STREET, PARDIS TECHNOLOGY PARK-PARDIS-TEHRAN-IRANIRANORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER
93NDA/MAL/HHP/8979LEXINE TECHNOCHEM PVT LTDMUKWANO PHARMACEUTICALS LIMITEDKWIK PAIN BALMLEXINE TECHNOCHEM PVT LTD -SURVEY PLOT NO. 373,
OPP. RAMAKAKA DERI CHHANI, VADODARA – 391704 GUJARAT, INDIA
INDIATOPICAL EXTERNAL OINTMENTS1.0X10.0 G TUBE,1.0X22.0 G TUBE
94NDA/MAL/HHP/9026LEXINE TECHNOCHEM PVT LTDMUKWANO PHARMACEUTICALS LIMITEDBABY CARE + GRIPE WATER 130MLLEXINE TECHNOCHEM PVT LTD -SURVEY PLOT NO. 373,
OPP. RAMAKAKA DERI CHHANI, VADODARA – 391704 GUJARAT, INDIA
INDIAORAL LIQUID ORDINARY LIQUIDS1.0X130.0 ML BOTTLE
S/NNDA REGISTRATION NUMBERLICENSE HOLDERLOCAL TECHNICAL REPRESENTATIVENAME OF DRUGMANUFACTURERCOUNTRY OF MANUFACTUREDOSAGE FORMPACK SIZE
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
KENYAUNKNOWN OILS1.0X100.0 ML BOTTLE,1.0X250.0 ML BOTTLE
S/NNDA REGISTRATION NUMBERLICENSE HOLDERLOCAL TECHNICAL REPRESENTATIVENAME OF DRUGGENERIC NAME OF DRUGSTRENGTH OF DRUGMANUFACTURERCOUNTRY OF MANUFACTUREDOSAGE FORMPACK SIZE
1NDA/MAL/HDP/0002ABACUS PARENTERAL DRUGS LIMITEDABACUS 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
2NDA/MAL/HDP/0003UNI MEDICO LABSHREEJI PHARMACEUTICALS LIMITEDUMOXIL CLAV 625AMOXICILLIN + CLAVULANATE POTASSIUM500 MG + 125 MGUNI MEDICOLABS-21-22 PHARMACITY SELAQUI DEHRADUN 248197INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X7.0 TABLET BLISTER
3NDA/MAL/HDP/0005STALLION LABORATORIES PVT LTDSHREEJI PHARMACEUTICALS LIMITEDALPRAZEC 0.25ALPRAZOLAM0.25MGACME FORMULATION PVT LTD -ROPAR ROAD NALAGARH DIST SOLAN HIMACHAL PRADESHINDIAORAL SOLID ORDINARY COATED TABLETS1.0X4.0X10.0 TABLET BLISTER
4NDA/MAL/HDP/0007AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDPROCIP SYRUPCYPROHEPTADINE HYDROCHLORIDE2MG/5MLAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE
5NDA/MAL/HDP/0008STALLION LABORATORIES PVT LTDSHREEJI PHARMACEUTICALS LIMITEDOMEPRICOMEPRAZOLE DELAYED-RELEASE20MGACME FORMULATION PVT LTD.-ROPAR ROAD NALAGARH DIST SOLAN HIMACHAL PRADESHINDIAORAL SOLID RETARD CAPSULES1.0X10.0X10.0 CAPSULE BLISTER
6NDA/MAL/HDP/0009STALLION LABORATORIES PVT LTDSHREEJI PHARMACEUTICALS LIMITEDDINASOD-100DICLOFENAC100MGACME FORMULATION PVT LTD,-ACME FORMULATION PVT LTD ROPAR ROAD NALAGARH DIST SOLAN HIMACHAL PRADESHINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER
7NDA/MAL/HDP/0010STALLION LABORATORIES PVT LTDSHREEJI PHARMACEUTICALS LIMITED02-LONOFLOXACIN + ORNIDAZOLE200MG + 500MGACME FORMULATION PVT LTD.-ROPAR ROAD, NALAGARH, DIST. SOLAN, HIMACHAL PRADESH 174101 INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER
8NDA/MAL/HDP/0016REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDCODIMEX-CT TABLETSCETIRIZINE DIHYDROCHLORIDE10MGREGAL PHARMACEUTICALS LIMITED -PLOT 7879/18 OF BABA DOGO ROAD, RUARAKA, NAIROBIKENYAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X10.0 TABLET BLISTER
9NDA/MAL/HDP/0017SWISS PARENTERALS PVT LTDSHREEJI PHARMACEUTICALS LIMITEDHYCORTHYDROCORTISONE100MGSWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIAINDIAPARENTERAL ORDINARY DRY VIALS1.0X10.0X7.5 ML VIAL
10NDA/MAL/HDP/0021SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDQUINSQUININE DIHYDROCHLORIDE300MG/MLSAKAR HEALTHCARE PVT. LTD-PLOT 10/13 SAKHEJ-BAVLA ROAD, AHMEDABAD,GUJURAT,INDIAINDIAPARENTERAL ORDINARY AMPOULES1.0X100.0X2.0 ML AMPOULE,1.0X2.0X5.0X2.0 ML AMPOULE
11NDA/MAL/HDP/0022AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDQUININE SULPHATEQUININE SULPHATE300MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
12NDA/MAL/HDP/0024KOPRAN LIMITEDTATA UGANDA LIMITEDAMPICLOXAAMPICILLIN + CLOXACILLIN250 MG + 250 MGKOPRAN LIMITED-VILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIAINDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER
13NDA/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, INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER
14NDA/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 INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER
15NDA/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, INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER
16NDA/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, INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER
17NDA/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
INDIAORAL LIQUID ORDINARY LIQUIDS1.0X5.0X2.0 ML AMPOULE
18NDA/MAL/HDP/0031MANKIND PHARM LTDTATA UGANDA LIMITEDCEFTATIME-SB 1.5CEFTRIAXONE+SULBACTAM1000MG+500MGMANKIND PHARMA LTD--VILLAGE KISHANPURA P.O JAMNI WALA TEHSIL PAONTA SAHIB DISTT SIRMOUR 173025 HIMACHAL PRADESHINDIAPARENTERAL ORDINARY DRY VIALS1.0X1.5 G VIAL
19NDA/MAL/HDP/0033ELYS CHEMICAL INDUSTRIES LTDVELVET PHARMA LIMITEDELYVATE CREAMBETAMETHASONE VALERATE0.1%W/WELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBIKENYATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE
20NDA/MAL/HDP/0037MIRACALUS PHARMA PVT.LTDAIVEEN (U) LIMITEDL-ASPASEL-ASPARGINASE 1000 I.UNAPROD LIFE SCIENCE PVT LTD-PLOT G-17/1 MIDC TARAPUR BOISAR, DIST. THANE-401506
MAHARASTRA, INDIA.
INDIAPARENTERAL ORDINARY I M VIALS1.0X10.0 ML VIAL
21NDA/MAL/HDP/0038MIRACALUS PHARMA PVT.LTDAIVEEN (U) LIMITEDARZI 200DACARBAZINE200MGNAPROD LIFE SCIENCE PVT LTD-PLOT G-17/1 MIDC TARAPUR BOISAR, DIST. THANE-401506
MAHARASTRA, INDIA.
INDIAPARENTERAL ORDINARY VIALS1.0X20.0 ML VIAL
22NDA/MAL/HDP/0039MIRACALUS PHARMA PVT.LTDAIVEEN (U) LIMITEDNZYTOPETOPOSIDE INJECTION USP100MGNAPROD LIFE SCIENCE PVT LTD-PLOT G-17/1 MIDC TARAPUR BOISAR, DIST. THANE-401506
MAHARASTRA, INDIA.
INDIAPARENTERAL ORDINARY VIALS1.0X5.0 ML VIAL
23NDA/MAL/HDP/0041RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDRECIMCIMETIDINE200MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKAUGANDAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER
24NDA/MAL/HDP/0042MIRACALUS PHARMA PVT.LTDAIVEEN (U) LIMITEDCISPLATINCISPLATIN1MG/MLNAPROD LIFE SCIENCE PVT LTD-PLOT G-17/1 MIDC TARAPUR BOISAR, DIST. THANE-401506
MAHARASTRA, INDIA.
INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X50.0 ML VIAL
25NDA/MAL/HDP/0043KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMADOL JUNIORPARACETAMOL250MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALAUGANDAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER
26NDA/MAL/HDP/0044MIRACALUS PHARMA PVT.LTDAIVEEN (U) LIMITEDNAPRO-TAXPACLITAXEL6MG/MLNAPROD LIFE SCIENCE PVT LTD-PLOT G-17/1 MIDC TARAPUR BOISAR, DIST. THANE-401506
MAHARASTRA, INDIA.
INDIAPARENTERAL ORDINARY OTHER VIALS1.0X1.0X20.0 ML VIAL
27NDA/MAL/HDP/0045AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOMOLPARACETAMOL500MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER
28NDA/MAL/HDP/0046MIRACALUS PHARMA PVT.LTDAIVEEN (U) LIMITEDABINGEMGEMCITABINE1GNAPROD LIFE SCIENCES PVT LTD-G-17, MIDC, TARAPUR INDUSTRIAL AREA, BIOSAR THANE, MUMBAIINDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0 G VIAL
29NDA/MAL/HDP/0047MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDLAMIHOPE ETEFAVIRENZ + LAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE600MG + 300MG + 300MGMACLEODS PHARMACEUTICALS LIMITED (BLOCK –N1)-VILLAGE THEDA, P.O. LODHI MAJRA,TEHSIL BADDI, HIMACHAL PRADESH -174101,INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X30.0 TABLET BOTTLE
30NDA/MAL/HDP/0051H. LUNDBECK A/SPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDCLOPIXOL ACUPHASE ZUCLOPENTHIXOL ACETATE50MG/MLH. LUNDBECK A/S - OTTILIAVEJ 9,2500 VALBYDENMARKPARENTERAL ORDINARY AMPOULES1.0X1.0 ML AMPOULE
31NDA/MAL/HDP/0052MEDICAL UNION PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.DISPERCAMPIROXICAM0.5%W/VMEDICAL UNION PHARMACEUTICALS CO -36 DR MOHAMED HASSAN EL GAMAL ST. 6TH DISTRICT NASR CITY, CAIROEGYPTTOPICAL EXTERNAL GELS AND SOLS1.0X15.0 G TUBE,1.0X30.0 G TUBE
32NDA/MAL/HDP/0053H. LUNDBECK A/SPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDFLUANXOL DEPOTFLUPENTIXOL DECANOATE20MG/MLH. LUNDBECK A/S ,.,-OTTILIAVEJ 9, DK-2500, VALBY-COPENHAGENDENMARKPARENTERAL RETARD AMPOULES1.0X1.0 ML AMPOULE
33NDA/MAL/HDP/0054GOOD DAY PHARMACY LIMITEDGOOD DAY PHARMACY LIMITEDFUNGOALCLOTRIMAZOLE1%W/WKREMOINT PHARMA PVT LTD---B-8 ADDITIONAL AMBERNATH MIDC OPP. ANAND NAGAR POLICE CHECK POST AMBERNATH (E) DIST THANE 421 506INDIATOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE
34NDA/MAL/HDP/0055H.LUNDBECK A/SPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDCLOPIXOL DEPOT ZUCLOPENTHIXOL DECANOATE200MG/MLH. LUNDBECK A/S ,.,-OTTILIAVEJ 9, DK-2500, VALBY-COPENHAGENDENMARKPARENTERAL ORDINARY AMPOULES1.0X1.0 ML AMPOULE
35NDA/MAL/HDP/0056TROIKAA PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDDYNAPAR QPSDICLOFENAC4%W/VTROIKAA PHARMACEUTICALS LTD-THOL VILLAGE, DIST. MEHSANA- 382728, GUJARAT, INDIAINDIATOPICAL EXTERNAL SPRAYS WITHOUT GAS1.0X30.0 ML BOTTLE
36NDA/MAL/HDP/0059NABIQASIM INDUSTRIES (PVT) LTD.JEET PHARMACEUTICALS LIMITEDVAGIBACT CREAMCLINDAMYCIN PHOSPHATE2%W/WNABIQASIM INDUSTRIES (PVT) LTD?-17/24,KORANGI INDUSTRIAL AREA, KORANGI, KARACHI- PAKISTAN.
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37NDA/MAL/HDP/0060MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDGONAL-F PEN 300 IU/0,5 ML (22 µG/0,5 ML)FOLLITROPIN ALFA22 µG/0,5 MLMERCK SERONO S.A. (MSA) -1170 SUCCURSALE D’AUBONNE ZONE INDUSTRIELLE DE L’OURIETTAZ, SWITZERLANDSWITZERLANDPARENTERAL ORDINARY PRE-FILLED PENS1.0X1.0 CARTRIDGE PREFILLED PEN + 8 NEEDLES FOR INJECTION
38NDA/MAL/HDP/0063HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDABACAVIR SULPHATE + LAMIVUDINEABACAVIR SULFATE + LAMIVUDINE600MG + 300MGHETERO LABS LTD. UNIT (V)-439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE),
JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA.
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39NDA/MAL/HDP/0064MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDGONAL-F PEN 450 IU/ IE 0,75 ML (33 µG)FOLLITROPIN ALFA33µG/ 0.7MLMERCK SERONO S.A. (MSA) -1170 SUCCURSALE D’AUBONNE ZONE INDUSTRIELLE DE L’OURIETTAZ, SWITZERLANDSWITZERLANDPARENTERAL ORDINARY CARTRIDGES1.0X1.0 CARTRIDGE PREFILLED PEN + 12 NEEDLES FOR INJECTION
40NDA/MAL/HDP/0067SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDARTEES?-? ARTEETHER75MG/MLSAKAR HEALTHCARE PVT LTD --406, SILVER OAKS COMMERCIAL COMPLEX,INDIAPARENTERAL ORDINARY AMPOULES1.0X3.2 ML AMPOULE
41NDA/MAL/HDP/0069PFIZER LABORATORIES PTY LTDLABOREX UGANDA LIMITEDLIPITORATORVASTATIN10MGPFIZER LABORATORIES-GODECKE MOOSWALDALLE 179090 FR ,PFIZER PHARMACEUTICALS LLC, ROAD 689 KM 1.9 VEGA BAJA, PUERTO RICOGERMANYORAL SOLID ORDINARY TABLETS1.0X28.0 TABLET BLISTER
42NDA/MAL/HDP/0070PFIZER LABORATORIES PTY LTDLABOREX UGANDA LIMITEDLIPITORATORVASTATIN20MGPFIZER LABORATORIES-GODECKE MOOSWALDALLE 179090 FR ,PFIZER PHARMACEUTICALS LLC, ROAD 689 KM 1.9 VEGA BAJA, PUERTO RICOGERMANYORAL SOLID ORDINARY TABLETS1.0X28.0 TABLET BLISTER
43NDA/MAL/HDP/0072VHB MEDI SCIENCES LTDLLOYDS PHARMACY UGANDA LTD.AMTERICINAMPHOTERICIN50MGVHB MEDI SCIENCES LTD-PLOT 20, 21, 22 & 49,50, 51. INTEGRATED INDUSTRIAL AREA SECTOR 5, RUDRAPUR, UTTARAKHAND - INDIAINDIAPARENTERAL ORDINARY VIALS1.0X50.0 MG VIAL
44NDA/MAL/HDP/0073NAARI LTDECHO PHARMACY (U) LIMITEDFASILE-ONELEVONORGESTREL TABLETS BP1.5MGNAARI PHARMA PRIVATE LIMITED-PLOT NO. 14-16, 55-57, SECTOR-5, IIE, PANT NAGAR RUDRAPUR-263153 DIST-U.S. NAGAR UTTARAKHANDINDIAORAL SOLID ORDINARY TABLETS1.0X1.0 TABLET BLISTER
45NDA/MAL/HDP/0075SUN PHARMACEUTICAL INDUSTRIES LIMITEDSTAR PHARMACEUTICALS LTDSYNRIAMARTEROLANE MALEATE + PIPERAQUINE PHOSPHATE150 MG + 750 MGSUN PHARMACEUTICALS IND. LTD-B-2,MADAKAI INDUSTRIAL ESTATE, PONDA,GOA-403404, INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X3.0 TABLET BLISTER
46NDA/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 VIAL
47NDA/MAL/HDP/0079MYLAN LABORATORIES LIMITED.NORVIK ENTERPRISES LIMITEDREVOKE 72LEVONORGESTREL750MCGMYLAN LABORATORIES LIMITED.--PLOT NO. 1606-1609, SARIGAM INDUSTRIAL AREA, GIDC, SARIGAM, TAL-UMERGAM, DIST VALSAD, 396155, GUJARAT, INDIA.,MYLAN LABORATORIES LIMITED..-PLOT NO.20 & 21, PHARMEZ, SARKHEJ-BAVLA NATIONAL HIGHWAY NO. 08A, NEAR VILLAGE MATODA, TAL-SANAND, AHMEDABAD, GUJARAT, INDIA 382213INDIAORAL SOLID ORDINARY TABLETS1.0X2.0 TABLET BLISTER
48NDA/MAL/HDP/0083MYLAN LABORATORIES LIMITED.NORVIK ENTERPRISES LIMITEDZINNIA-FLEVONORGESTREL & ETHINYLESTRADIOL + FERROUS FUMARATE150MCG + 30MCG + 75MGMYLAN LABORATORIES LIMITED.--PLOT NO. 1606-1609, SARIGAM INDUSTRIAL AREA, GIDC, SARIGAM, TAL-UMERGAM, DIST VALSAD, 396155, GUJARAT, INDIA.,MYLAN LABORATORIES LIMITED..-PLOT NO.20 & 21, PHARMEZ, SARKHEJ-BAVLA NATIONAL HIGHWAY NO. 08A, NEAR VILLAGE MATODA, TAL-SANAND, AHMEDABAD, GUJARAT, INDIA 382213INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X28.0 TABLET BLISTER
49NDA/MAL/HDP/0085HETERO LABS LTD UNIT IXABACUS PHARMA (AFRICA) LIMITEDPIOGEN-30PIOGLITAZONE HYDROCHLORIDE30MGHETERO LABS LTD. UNIT (V)-S.N0.439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE),
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INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER
50NDA/MAL/HDP/0088AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDD-LYTE CO-PACKANHYDROUS GLUCOSE/SODIUM CHLORIDE/TRISODIUM CITRATE/POTASSIUM CHLORIDE(2.7G/0.52G/0.58G/0.3G)/20MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL 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 BLISTERS
51NDA/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 BLISTER
52NDA/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 BLISTER
53NDA/MAL/HDP/0097MSN LABORATORIES LTDPLANET PHARMACEUTICALS UGANDA LTDSAFELEVO 750LEVOFLOXACIN 750MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER
54NDA/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 CONTAINER
55NDA/MAL/HDP/0101AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOTETRA CAPSULES (THANE)TETRACYCLINE HYDROCHLORIDE250MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL 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 BLISTER
56NDA/MAL/HDP/0102MSN LABORATORIES LTDPLANET PHARMACEUTICALS UGANDA LTDSILMELT 100SILDENAFIL CITRATE100MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X2.0 TABLET BLISTER
57NDA/MAL/HDP/0104MSN LABORATORIES LTDPLANET PHARMACEUTICALS UGANDA LTDSILMELT 50SILDENAFIL CITRATE50MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY TABLETS1.0X2.0X2.0 TABLET BLISTER
58NDA/MAL/HDP/0105AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOSPRIN TABLETSACETYL SALICYLIC ACID300MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS10.0X10.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER
59NDA/MAL/HDP/0106MSN LABORATORIES LTDPLANET PHARMACEUTICALS UGANDA LTDSAFELEVOLEVOFLOXACIN500MG/100MLMARCK BIOSCIENCES -PLOT NO 876, NH NO 8 HARIYALA KHEDA- 387411 GUJARAT, INDIAINDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X1.0X100.0 ML BOTTLE
60NDA/MAL/HDP/0112NORVATIS PHARMA AGSURGIPHARM (U) LIMITEDEXFORGE 5MG/160MGAMLODIPINE + VALSARTAN5 MG + 160 MGNOVARTIS PHARMA STEIN AG-H-4332 STEIN SCHAFFAUSERTRASSE,NOVARTIS FARMACEUTICA SA-RONDA DE SANTA MARIA,158, E-08210 BARBERA DEL VALLES BARCELONA SPAINSWITZERLANDORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X14.0 TABLET BLISTER
61NDA/MAL/HDP/0114MSN LABORATORIES LTDPLANET PHARMACEUTICALS UGANDA LTDBREATHEZY 4MONTELUKAST SODIUM4MGMSN LABORATORIES LTD -PLOT NO. 42 INDUSTRIAL ESTARE BOLLARAM MEDAK DISTRIC 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY CHEWABLE TABLETS1.0X3.0X10.0 TABLET BLISTER
62NDA/MAL/HDP/0117ALKEM LABORATORIES LIMITEDABACUS PHARMA (AFRICA) LIMITEDZOCEF 1.5GCEFUROXIME SODIUM1.5GALKEM LABORATORIES LTD-VILLAGE – THANA, BADDI TEHSIL – NALAGARH, DIST-SOLAN (HP), INDIA – 173205INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0X1.5 G VIAL
63NDA/MAL/HDP/0118ALKEM LABORATORIES LIMITEDABACUS PHARMA (AFRICA) LIMITEDZOCEF 750MGCEFUROXIME SODIUM750MGALKEM LABORATORIES LTD-VILLAGE – THANA, BADDI TEHSIL – NALAGARH, DIST-SOLAN (HP), INDIA – 173205INDIAPARENTERAL ORDINARY DRY VIALS1.0X750.0 MG VIAL
64NDA/MAL/HDP/0119DAWA LIMITEDSUPER MEDIC LTDDACOLDCAFFEINE ANHYDROUS+CHLORPHENIRAMINE MALEATE+PARACETAMOL+PSUDOEPHEDRINE30MG+4MG+400MG+30MGDAWA LIMITED -BABA DOGO RWARAKAKENYAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER
65NDA/MAL/HDP/0122NABROS PHARMA PVT LTDSHREEJI PHARMACEUTICALS LIMITEDLEVOXINE-500LEVOFLOXACIN HEMIHYDRATE500MGNABROS PHARMA PVT. LTD-3RD FLOOR, NABROS HOUSE, OPP. ART GALLERY,
BEHIND BRITISH LIBRARY, LAW GARDEN,
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66NDA/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 BOTTLE
67NDA/MAL/HDP/0125DAWA LIMITEDSUPER MEDIC LTDSULPHUR OINTMENTSULPHUR10%W/WDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYATOPICAL EXTERNAL OINTMENTS1.0X20.0 G TUBE
68NDA/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 TUBE
69NDA/MAL/HDP/0127DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDCORYCARDONIRBESARTAN + HYDROCHLOROTHIAZIDE300MG + 12.5MG ZHEJIANG HUAHAI PHARMACEUTICAL CO. LTD-XUNQIAO, LINHAI, ZHEJIANG PROVINCE 317024 PEOPLES’ REPUBLIC OF CHINACHINAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER
70NDA/MAL/HDP/0128DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDCORYCARDONIRBESARTAN + HYDROCHLOROTHIAZIDE150MG + 12.5MG ZHEJIANG HUAHAI PHARMACEUTICAL CO. LTD-XUNQIAO, LINHAI, ZHEJIANG PROVINCE 317024 PEOPLES’ REPUBLIC OF CHINACHINAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER
71NDA/MAL/HDP/0129HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDPIOGENPIOGLITAZONE HYDROCHLORIDE15MGHETERO LABS LIMITED UNIT V-APIIC PHARMA SEZ, S. NO. 439, 440, 441 & 458 POLEPALLY VILLAGE, JADCHERLA MANDAL, MAHABOOBNAGAR (DISTRICT). PIN 509301INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER
72NDA/MAL/HDP/0130CADILA PHARMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.TRIGAN -DDICYCLOMINE HYDROCHLORIDE10MG/MLCADILA PHARMACEUTICALS LTD-1389 DHOLKA 387 810 DIST AHMEDABAD GUJARATINDIAPARENTERAL ORDINARY AMPOULES1.0X2.0 ML AMPOULE
73NDA/MAL/HDP/0131ABBOT LABORATORIES S.A. (PTY) LTDHARLEYS UGANDA LIMITEDKLACID P125CLARITHROMYCIN125MG/5MLABBOTT LABORATORIES S.A (PTY) LTD-ABBOTT PLACE,219 GOLF CLUB
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74NDA/MAL/HDP/0132ABBOT LABORATORIES S.A. (PTY) LTDHARLEYS UGANDA LIMITEDKLACID 500MGCLARITHROMYCIN500MGABBOTT LABORATORIES S.A (PTY) LTD-ABBOTT PLACE,219 GOLF CLUB
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75NDA/MAL/HDP/0133ABBOT LABORATORIES S.A. (PTY) LTDHARLEYS UGANDA LIMITEDKLACID P250CLARITHROMYCIN250MG/5MLABBOTT LABORATORIES S.A (PTY) LTD-ABBOTT PLACE,219 GOLF CLUB
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76NDA/MAL/HDP/0139ANGLIAN NUTRITION PRODUCTS COMPANYSUPER MEDIC LTDMOXAFORTEFLUCLOXACILLIN SODIUM + AMOXICILLIN TRIHYDRATE250MG + 250MGDAWA PHARMACEUTICALS LIMITED-PLOT 7879, BABA DOGO ROAD RUARAKAKENYAORAL SOLID ORDINARY CAPSULES1.0X2.0X10.0 CAPSULE BLISTER
77NDA/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 AREAKENYAORAL LIQUID ORDINARY SUSPENSIONS1.0X30.0 ML BOTTLE
78NDA/MAL/HDP/0142PFIZER LAB LTDLABOREX UGANDA LIMITEDPREVENAR 13PNEUMOCOCCAL POLYSACCHARIDE CONJUGATE VACCINE (13-VALENT.ADSORBED)2.2MCG OF POLYSACCHARIDE FOR SEROTYPES 1,3,4,5,6A,7F.9V,14,18C,19A,19F,23F,AND 4.4MCG FOR SEROTYPE 6BWYETH PHARMACEUTICALS INC-401 N MIDDLETOWN RD PEARL RIVER NY 10965UNITED STATESPARENTERAL ORDINARY VIALS1.0X0.5 ML VIAL (1 DOSE)
79NDA/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, CYPRUSCHINAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER
80NDA/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, CYPRUSCHINAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER
81NDA/MAL/HDP/0155TORRENT PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.ASTHATOR 10MONTELUKAST SODIUM10MGTORRENT PHARMACEUTICALS LTD .,-AHMEDABAD-MEHSANA HIGHWAY, TALUKA-KADI, DIST. MEHSANA, INDRAD-382721, GUJARATINDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER
82NDA/MAL/HDP/0157RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDRECODINCODEINE PHOSPHATE + CHLORPHENIRAMINE MALEATE10MG + 4MG /5MLRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKAUGANDAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE
83NDA/MAL/HDP/0158MEGA LIFESCIENCES (AUSTRALIA) PTY LTDABACUS PHARMA (AFRICA) LIMITEDKIPEL 10MONTELUKAST SODIUM10MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER
84NDA/MAL/HDP/0161RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDTRAMARENTRAMADOL HYDROCHLORIDE50MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKAUGANDAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER
85NDA/MAL/HDP/0162RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDCOSYP-D LINCTUSDEXTROMETHORPHAN HYDROBROMIDE + CHLORPHENAMINE MALEATE10MG +4MG /5MLRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKAUGANDAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE
86NDA/MAL/HDP/0163RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDPHENARENPROMETHAZINE HYDROCHLORIDE5MG/5MLRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKAUGANDAORAL LIQUID ORDINARY SYRUPS1.0X60.0 ML BOTTLE
87NDA/MAL/HDP/0164RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDRENPRESSPROPRANOLOL40MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKAUGANDAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER
88NDA/MAL/HDP/0165TORRENT PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.TOLANZ 5OLANZAPINE ORODISPERSIBLE TABLETS5MGTORRENT PHARMACEUTICALS LTD .,-AHMEDABAD-MEHSANA HIGHWAY, TALUKA-KADI, DIST. MEHSANA, INDRAD-382721, GUJARATINDIAORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS1.0X3.0X10.0 TABLET BLISTER
89NDA/MAL/HDP/0166RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDX-PELMEBENDAZOLE100MG/5MLRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKAUGANDAORAL LIQUID ORDINARY SUSPENSIONS1.0X30.0 ML BOTTLE
90NDA/MAL/HDP/0167TORRENT PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.TOLANZ 10OLANZAPINE ORODISPERSIBLE TABLETS10MGTORRENT PHARMACEUTICALS LTD .,-AHMEDABAD-MEHSANA HIGHWAY, TALUKA-KADI, DIST. MEHSANA, INDRAD-382721, GUJARATINDIAORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS1.0X3.0X10.0 TABLET BLISTER
91NDA/MAL/HDP/0168MSN LABORATORIES LTDPLANET PHARMACEUTICALS UGANDA LTDFEBUDAYFEBUXOSTAT80MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER
92NDA/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 BLISTER
93NDA/MAL/HDP/0174GLAXO SMITHKLINE LTDERIS LTDFLIXOTIDE 50FLUTICASONE PROPIONATE50MCGGLAXO WELLCOME S.A.-AVENIDA DE EXTREMADURA 3
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94NDA/MAL/HDP/0175BAYER SCHERING PHARMASURGIPHARM (U) LIMITEDXARELTO 10MGRIVAROXABAN10MGBAYER HEALTHCARE AG,-D-51368, LEVERKUSENGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X10.0 TABLET BLISTER
95NDA/MAL/HDP/0177MSN LABORATORIES LTDPLANET PHARMACEUTICALS UGANDA LTDILET B2GLIMEPIRIDE+METFORMIN HYDROCHLORIDE2MG+500 MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER
96NDA/MAL/HDP/0178REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDCOLDCAP DAYTIME AND NIGHT TIME CAPSULEDAY TIME(PARACETAMOL +CAFFEINE ANHYDROUS+PSEUDOEPHEDRINE HCL) AND NIGHT TIME(PARACETAMOL +CHLORPHENIRAMINE MALEATE)DAY TIME (500MG + 30MG + 30MG) AND NIGHT TIME (500MG +2MG)REGAL PHARMACEUTICALS LIMITED -PLOT 7879/18 OF BABA DOGO ROAD, RUARAKA, NAIROBIKENYAORAL SOLID ORDINARY CAPSULES1.0X3.0X8.0 CAPSULE BLISTER
97NDA/MAL/HDP/0182MSN LABORATORIES LTDPLANET PHARMACEUTICALS UGANDA LTDFEBUDAY 40FEBUXOSTAT40MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER
98NDA/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 BOTTLE
99NDA/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 BLISTER
100NDA/MAL/HDP/0189CIPLA LTDQUALITY CHEMICALS LTD - HUMANNEVIMUNE TABLETSNEVIRAPINE200MGCIPLA LTD--PLOT NO L-139,VERNA IND ESTATE, VERNA GOA-403 INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X6.0X10.0 TABLET BLISTER,1.0X60.0 TABLET CONTAINER
101NDA/MAL/HDP/0191MEDOPHARM PRIVATE LIMITEDPLANET PHARMACEUTICALS UGANDA LTDCLEDOMOX 228.5AMOXICILLIN + CLAVULANATE200 MG + 28.5 MGMEDOPHARM PVT LTD.-NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADUINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X70.0 ML BOTTLE
102NDA/MAL/HDP/0193MEDOPHARM PRIVATE LIMITEDPLANET PHARMACEUTICALS UGANDA LTDCLEDOMOX 625AMOXICILLIN + CLAVULANIC ACID500 MG + 125 MGMEDOPHARM PVT LTD.-NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADUINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X7.0 TABLET BLISTER
103NDA/MAL/HDP/0196CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDCIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDDUOVIRLAMIVUDINE/ZIDOVUDINE150MG/300MGCIPLA QUALITY CHEMICAL INDUSTRIES LIMITED - -PLOT 1-7 1ST RING ROAD, LUZIRA, KAMPALAUGANDAORAL SOLID ORDINARY OTHER COATED TABLETS1.0X60.0 TABLET CONTAINER
104NDA/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 INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET CONTAINER
105NDA/MAL/HDP/0198CIPLA LIMITEDCIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDNEVIRAPINE TABLETS 200 MGNEVIRAPINE200MGCIPLA QUALITY CHEMICAL INDUSTRIES LIMITED - -PLOT 1-7 1ST RING ROAD, LUZIRA, KAMPALAUGANDAORAL SOLID ORDINARY TABLETS1.0X60.0 TABLET BOTTLE
106NDA/MAL/HDP/0201GLAXO SMITH KLINE LTDERIS LTDFLIXOTIDE 125FLUTICASONE PROPIONATE125MCGGLAXO WELLCOME S.A.-AVENIDA DE EXTREMADURA 3
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107NDA/MAL/HDP/0203GLAXOSMITHLINE LTDERIS LTDSERETIDE EVOHALER 250SALMETEROL XINAFOATE + FLUTICASONE PROPIONATE25MCG + 250MCGGLAXO WELLCOME-PRODUCTION ZONE INDUSTRIELLE NO. 2 23, RUE LAVOISIER 27000 EVREUXFRANCELUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER1.0X120.0 METERED DOSE CANNISTER
108NDA/MAL/HDP/0204GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDTIVICAYDOLUTEGRAVIR SODIUM50MGGLAXO OPERATIONS UK LTD-WARE SG120DJ UNITED KINGDOMUNITED KINGDOMORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET CONTAINER
109NDA/MAL/HDP/0205MACLEODS PHARMACEUTICALS LTDS LTDNORVIK ENTERPRISES LIMITEDTENOFOVIR DISOPROXIL FUMARATETENOFOVIR DISOPROXIL FUMARATE300MGMACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET BOTTLE
110NDA/MAL/HDP/0207MACLEODS PHARMACEUTICAL LTDNORVIK ENTERPRISES LIMITEDLAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATELAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE300MG +300MGMACLEODS PHARMACEUTICALS LTD---PLOT NO 25-27 SURVEY PREMEIRE INDUSTRIAL ESTATE KACHIGAM DAMAN (U.T) 396401,MACLEODS PHARMACEUTICALS LIMITED (BLOCK –N1)-VILLAGE THEDA, P.O. LODHI MAJRA,TEHSIL BADDI, HIMACHAL PRADESH -174101,INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X30.0 TABLET BOTTLE
111NDA/MAL/HDP/0209HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDABACAVIR SULPHATE ORAL SOLUTIONABACAVIR SULPHATE20MG/MLHETERO LABS LTD, UNIT III-KALYANPUR, CHAKKAN ROAD, BADDI, DIST. SOLAN, HIMACHAL PRADESH, INDIAINDIAORAL LIQUID ORDINARY LIQUIDS1.0X240.0 ML BOTTLE
112NDA/MAL/HDP/0210MEDICAL UNION PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.HEPATICUMSILYMARIN140MGMEDICAL UNION PHARMACEUTICALS-36 DR MOHAMED HASSAN EL-GAMAL ST.6TH DISTRICT NASR CITY EGYPTEGYPTORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER
113NDA/MAL/HDP/0212MEDICAL UNION PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.HEPATICUMSILYMARIN1G/100MLMEDICAL UNION PHARMACEUTICALS-36 DR MOHAMED HASSAN EL-GAMAL ST.6TH DISTRICT NASR CITY EGYPTEGYPTORAL LIQUID ORDINARY SUSPENSIONS1.0X120.0 ML BOTTLE
114NDA/MAL/HDP/0217ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDPALETHERARTEMETHER80MG/MLLINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARATINDIAPARENTERAL ORDINARY I M AMPOULES2.0X3.0X1.0 ML AMPOULE
115NDA/MAL/HDP/0221DAWA LIMITEDSUPER MEDIC LTDAMPICLO-DAWAAMPICILLIN + CLOXACILLIN250 MG + 250 MGDAWA PHARMACEUTICALS LIMITED-PLOT 7879, BABA DOGO ROAD RUARAKAKENYAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER
116NDA/MAL/HDP/0222ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDAVIR-200ACYCLOVIR500MGLINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARATINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER
117NDA/MAL/HDP/0223ABACUS PHARMA LTDABACUS PARENTERAL DRUGS LIMITEDTOPCID-150RANITIDINE150MGLINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARATINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET STRIP
118NDA/MAL/HDP/0225ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDDIKON PLUSDICLOFENAC/SALICYLATE/MENTHOL/LINSEED1%W/W+10%W/W+5%W/W+3%W/WLINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARATINDIATOPICAL EXTERNAL GELS AND SOLS1.0X15.0 G CONTAINER
119NDA/MAL/HDP/0228KOPRAN LIMITEDTATA UGANDA LIMITEDTRIM-960TRIMETHOPRIM/SULFAMETHOXAZOLE160MG/800MGKOPRAN LTD-VILLAGE SAVROLI TAL KHARAPUR DIST RAIGAD 410 202INDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
120NDA/MAL/HDP/0230STRIDES ARCOLAB LTDDELMAW ENTERPRISES LIMITEDCOMBIARTARTHEMETHER + LUMEFANTRINE20MG +120MGSTRIDES ARCOLAB LIMITED -36/7 SURAGAJAKKANAHALLI INDLAVADI CROSS ANEKAL TALUK BANGALORE 562 106INDIAORAL SOLID ORDINARY TABLETS1.0X4.0X6.0 TABLET BLISTER,1.0X1.0X6.0 TABLET BLISTER,1.0X1.0X12.0 TABLET BLISTER,1.0X1.0X18.0 TABLET BLISTER,1.0X1.0X24.0 TABLET BLISTER,1.0X24.0 TABLET BLISTER
121NDA/MAL/HDP/0232TORRENT PHARAMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.BRANTALOSARTAN POTASSIUM + AMLODIPINE BESILATE50MG + 5MGTORRENT PHARMACEUTICALS LTD .,-AHMEDABAD-MEHSANA HIGHWAY, TALUKA-KADI, DIST. MEHSANA, INDRAD-382721, GUJARATINDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER
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123NDA/MAL/HDP/0243UNIVERSAL CORPORATION LTDHARLEYS UGANDA LIMITEDLAMOZIDLAMIVUDINE + ZIDOVUDINE150MG +300MGUNIVERSAL CORPORATION LIMITED -PLOT 13777 KIKUYU ROAD, KIKUYU TOWN, PAST POST OFFICEKENYAORAL SOLID ORDINARY TABLETS1.0X60.0 TABLET BOTTLE
124NDA/MAL/HDP/0245CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDEUGLIM 4GLIMEPIRIDE4MGCADILA HEALTHCARE LTD -KUNDAIM INDUSTRIAL ESTATE PONDA GOA 403 401INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER
125NDA/MAL/HDP/0248IPCA LABORATORIES LTDMEDVIN PHARMA LIMITEDPANTONEX DR-40PANTOPRAZOLE40 MG IPCA LABORATORIES LTD-PLOT NO. 255/1,
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126NDA/MAL/HDP/0250ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDDIKONDICLOFENAC1%W/WLINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARATINDIATOPICAL EXTERNAL GELS AND SOLS1.0X20.0 G CONTAINER
127NDA/MAL/HDP/0251MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDLAMIVUDINE/ZIDOVUDINE/NEVIRAPINELAMIVUDINE + ZIDOVUDINE + NEVIRAPINE150MG + 300MG + 200MGMACLEODS PHARMACEUTICALS LTD(BLOCK N2)-VILLAGE THEDA,P.O LODHI MAJRA,TEHSIL BADDI,HIMACHAL PRADESH 174101,MACLEODS PHARMACEUTICALS LTD., NO. 25-27-PLOT NO. 25-26-27, SURVEY NO.366, PREMIER INDUSTRIAL ESTATE ., DAMAN - 396210, KACHIGAM, DAMANINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X60.0 TABLET BOTTLE
128NDA/MAL/HDP/0252LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDVAST-40ATORVASTATIN40MGLINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARATINDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER
129NDA/MAL/HDP/0254MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDCONCOR 5BISOPROLOL HEMIFUMARATE5MGMERCK KGAA-250 FRANKFRUTER STRASSE 250-64293 DARMSTADT,WINTHROP PHARMACEUTICALS(PTY) LTD,-315 WATLOO ROAD,WATLOO,PRETORIA,SOUTHAFRICA (FPP SECONDARY PACKAGING,FPP RELEASE/QC TESTING SITE)GERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER
130NDA/MAL/HDP/0255HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDCAPETERO 150CAPECITABINE150MGHETERO LABS (UNIT VI), INDIA-APIIC, FORMULATION SEZ, POLEPALLY (V),JEDCHERLA(M) MAHABOOBNAGER DISTRICT ANDHRA PRADESH-509301, INDIA.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X60.0 TABLET CONTAINER
131NDA/MAL/HDP/0256HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDCAPETERO 500CAPECITABINE500MGHETERO LABS (UNIT VI), INDIA-APIIC, FORMULATION SEZ, POLEPALLY (V),JEDCHERLA(M) MAHABOOBNAGER DISTRICT ANDHRA PRADESH-509301, INDIA.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X120.0 TABLET CONTAINER
132NDA/MAL/HDP/0257SANOFI AVENTS FRANCELABOREX UGANDA LIMITEDCORDARONEAMIODARONE HYDROCHLORIDE200MGSANOFI WINTHROP INDUSTRIE-LAGRAGE 33565 CARBON BLANC CEDEX FRANCE
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133NDA/MAL/HDP/0261HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDLOSAGEN -100LOSARTAN POTASSIUM100MGHETERO LABS LTD (UNIT-V)-SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER
134NDA/MAL/HDP/0267HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDPENVIR 750FAMCICLOVIR750MGHETERO LABS LTD (UNIT-V)-SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER
135NDA/MAL/HDP/0269LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDVOMISTAT-8ONDANSETRON8MGLINCOLN PHARMACEUTICALS LIMITED -10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
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136NDA/MAL/HDP/0270HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDLEVIN 500MGLEVOFLOXACIN HEMIHYDRATE500MGHETERO LABS LTD (UNIT-V)-SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER
137NDA/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 500078INDIAPARENTERAL ORDINARY AMPOULES1.0X20.0X10.0 ML AMPOULE,1.0X24.0X10.0 ML AMPOULE,1.0X5.0 ML VIAL (10 DOSES)
138NDA/MAL/HDP/0272HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDLEVIN 250LEVOFLOXACIN250MGHETERO LABS LTD. UNIT (V)-439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE),
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139NDA/MAL/HDP/0275GLAXO SMITHLINE LIMITEDERIS LTDZENTELALBENDAZOLE400MGGLAXOSMITHKLINE SOUTH AFRICA (PTY) LTD-39 HAWKINS AVENUE, EPPING INDUSTRIAL, CAPE TOWN, 7460, SOUTH AFRICASOUTH AFRICAORAL SOLID ORDINARY CHEWABLE TABLETS1.0X1.0 TABLET BLISTER
140NDA/MAL/HDP/0276MICRO LABS LTDLABOREX UGANDA LIMITEDMELANOV 80GLICLAZIDE80MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER
141NDA/MAL/HDP/0278COSMOS LTDASTRA PHARMA (U) LIMITEDCHLORPROMAZINE TABLETS B.P 100MGCHLORPROMAZINE HYDROCHLORIDE100MGCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBIKENYAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER
142NDA/MAL/HDP/0283DAWA LIMITEDSUPER MEDIC LTDAMPICLO-DAWAAMPICILLIN + CLOXACILLIN125 MG + 125 MGDAWA PHARMACEUTICALS LIMITED-PLOT 7879, BABA DOGO ROAD RUARAKAKENYAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE
143NDA/MAL/HDP/0284GLAXO SMITHLINE LIMITEDERIS LTDCLAVULINAMOXICILLIN + CLAVULANIC ACID1000 MG + 200 MGSMITHKLINE BEECHAM PHARMACEUTICALS,-CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QHUNITED KINGDOMPARENTERAL ORDINARY DRY VIALS10.0X1.2 G VIAL
144NDA/MAL/HDP/0287GOOD DAY PHARMACY LIMITEDGOOD DAY PHARMACY LIMITEDPOWER HEATMETHYL SALICYLATE BP15000MGKREMOINT PHARMA PVT LTD---B-8 ADDITIONAL AMBERNATH MIDC OPP. ANAND NAGAR POLICE CHECK POST AMBERNATH (E) DIST THANE 421 506INDIATOPICAL EXTERNAL CREAMS1.0X25.0 G TUBE,1.0X30.0 G TUBE
145NDA/MAL/HDP/0289ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDTETRASTETRACYCLINE HYDROCHLORIDE250MGASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIAINDIAORAL SOLID ORDINARY CAPSULES1.0X10000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER
146NDA/MAL/HDP/0290LABORATORY AND ALLIED LTDHARLEYS UGANDA LIMITEDNATOAMEBENDAZOLE100MGLABORATORY & ALLIED LTD--PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, MOMBASA ROAD P.O. BOX 42875, GPO 00100, NAIROBI, KENYAKENYAORAL SOLID ORDINARY CHEWABLE TABLETS1.0X1.0X6.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
147NDA/MAL/HDP/0296COSMOS LTDASTRA PHARMA (U) LIMITEDPRAZITEL TABLETSPRAZIQUANTEL600MGCOSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREAKENYAORAL SOLID ORDINARY FILM-COATED TABLETS2.0X10.0 TABLET BLISTER
148NDA/MAL/HDP/0298SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDSEFIXI-50 DRY SYRUPCEFIXIME50MGSAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIAINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X1.0X60.0 ML BOTTLE
149NDA/MAL/HDP/0301HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDMONTE - H 10MONTELUKAST SODIUM10MGHETERO LABS LTD. UNIT (V)-S.N0.439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE),
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150NDA/MAL/HDP/0303HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDABACAVIR SULPHATEABACAVIR SULPHATE300MGHETERO DRUGS LTD, UNIT III -22-110, IDA, JEEDIMETLAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X60.0 TABLET CONTAINER
151NDA/MAL/HDP/0304HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDDARUNAVIRDARUNAVIR400MGHETERO LABS LTD-22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESHINDIAORAL SOLID ORDINARY TABLETS1.0X60.0 TABLET CONTAINER
152NDA/MAL/HDP/0305SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDCEFAX-250 DRY SYRUPCEFALEXIN250MG/5MLSAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIAINDIAORAL LIQUID ORDINARY SOLUBLE POWDERS1.0X1.0X50.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE
153NDA/MAL/HDP/0308SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDCEFAX-250CEFALEXIN250MGSAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIAINDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER
154NDA/MAL/HDP/0310YURIA PHARM EAST AFRICA LIMITEDYURIA PHARM EAST AFRICA LIMITEDLATRENPENTOXIFYLLINE0.5MG/MLYURIA-PHARM, LTD-108, VERBOVETSKOGO STREET CHERKASSY, 18030, UKRAINEUKRAINEPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X200.0 ML BOTTLE
155NDA/MAL/HDP/0311MARTINDALE PHARMACEUTICALS LTDLABOREX UGANDA LIMITEDFENTANYLFENTANYL CITRATE50MCG/MLMARTINDALE PHARMACEUTICAL LIMITED -BAMPTON ROAD RMM38UG ENGLANDUNITED KINGDOMPARENTERAL ORDINARY AMPOULES1.0X2.0 ML AMPOULE
156NDA/MAL/HDP/0312SPARSH BIO-TECH PVT LTDABACUS PHARMA (AFRICA) LIMITEDCLOXISPA ORAL SOLUTION 125CLOXACILLIN125MG/5MLSPARSH BIO-TECH LTD-PLOT NO.1 SURVEY NO.242/234/244, VILLAGE LAKHABARAD, JAMNAGAR-361006INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE
157NDA/MAL/HDP/0314MARTINDALE PHARMACEUTICALS LTDLABOREX UGANDA LIMITEDSUXAMETHONIUM CHLORIDE SOLUTION FOR INJECTIONSUXAMETHONIUM CHLORIDE50MG/MLMARTINDALE PHARMA -BAMPTON ROAD, HAROLD HILL,ROMFORD,RM3844UNITED KINGDOMORAL LIQUID ORDINARY LIQUIDS1.0X10.0X2.0 ML AMPOULE
158NDA/MAL/HDP/0316YURIA PHARM EAST AFRICA LIMITEDYURIA PHARM EAST AFRICA LIMITEDOFLOXACIN-UFOFLOXACIN2MG/MLYURIA-PHARM, LTD. -18030 VERBOVETSKOGO STR. 108 CHERKASSY, UKRAINE..UKRAINEPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE
159NDA/MAL/HDP/0317YURIA PHARM EAST AFRICA LIMITEDYURIA PHARM EAST AFRICA LIMITEDCIPROFLOXACIN-UFCIPROFLOXACIN2MG/MLYURIA-PHARM, LTD-108, VERBOVETSKOGO STREET CHERKASSY, 18030, UKRAINEUKRAINEPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X200.0 ML BOTTLE,1.0X100.0 ML BOTTLE
160NDA/MAL/HDP/0318DAWA LIMITEDSUPER MEDIC LTDSABULINSALBUTAMOL4MGDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER
161NDA/MAL/HDP/0320DAWA LIMITEDSUPER MEDIC LTDDAZOLECLOTRIMAZOLE1%W/WDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYATOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE
162NDA/MAL/HDP/0322MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDNEBILONG-5NEBIVOLOL HCL5MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER
163NDA/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 INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X200.0 ML BOTTLE
164NDA/MAL/HDP/0327GLENMARK PHARMACUTICALS LTDSTAR PHARMACEUTICALS LTDFLEXILOR 8LORNOXICAM8MGGLENMARK PHARMACEUTICAL LIMITED;--VILLAGE KISHANPURA,BADDI-NALAGARH ROAD TEHSIL BADDI,DISTT. SOLAN, HIMACHAL PRADESH -174 101 INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER
165NDA/MAL/HDP/0330ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDASBUTOL-4SALBUTAMOL4MGASTRA LIFECARE (INDIA) PVT. LTD-PLOT 57/P, SARKHEJ-BAVLA HIGHWAY, RAJODA 382 220, AHMEDABAD, INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER
166NDA/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 INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X15.0 TABLET BLISTER
167NDA/MAL/HDP/0333KOPRAN LIMITEDTATA UGANDA LIMITEDCLAVAMYN-625AMOXICILLIN TRIHYDRATE + POTASSIUM CLAVULANATE500MG +125MGKOPRAN LIMITED-VILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER
168NDA/MAL/HDP/0335GOOD DAY PHARMACY LIMITEDGOOD DAY PHARMACY LIMITEDNEOMYCIN SULPHATE CREAM USPNEOMYCIN SULPHATE CREAM USP0.5%WWKREMOINT PHARMA PVT LTD-B-8,ADDITIONAL AMBERNATH MIDC, AMBERNATH (E),DIST: THANE 421506, INDIA INDIATOPICAL EXTERNAL CREAMS1.0X1.0X30.0 G TUBE
169NDA/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, INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET STRIP
170NDA/MAL/HDP/0337IND-SWIFTPLANET PHARMACEUTICALS UGANDA LTDSWAZI *500AZITHROMYCIN500MGIND SWIFT LTD-GLOBAL BUSINESS UNIT JAWAHARPUR OFF NH-21 DERABASSI DIST MOHALI PUNJAB 140507INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0 TABLET BLISTER
171NDA/MAL/HDP/0338KOPRAN LIMITEDTATA UGANDA LIMITEDKORAB 20RABEPRAZOLE SODIUM20MGKOPRAN LIMITED-VILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER
172NDA/MAL/HDP/0339IND-SWIFTPLANET PHARMACEUTICALS UGANDA LTDSWAZI *250AZITHROMYCIN250MGIND SWIFT LTD-GLOBAL BUSINESS UNIT JAWAHARPUR OFF NH-21 DERABASSI DIST MOHALI PUNJAB 140507INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X6.0 TABLET BLISTER
173NDA/MAL/HDP/0340GOOD DAY PHARMACY LIMITEDGOOD DAY PHARMACY LIMITEDSONADAYCLOBETASOL-17-BUTYRATE + GENTAMYCIN SULPHATE + MICONAZOLE NITRATE0.05%W/W+0.1%W/W+2%W/WKREMOINT PHARMA PVT LTD---B-8 ADDITIONAL AMBERNATH MIDC OPP. ANAND NAGAR POLICE CHECK POST AMBERNATH (E) DIST THANE 421 506INDIATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE
174NDA/MAL/HDP/0341IND SWIFT LTDPLANET PHARMACEUTICALS UGANDA LTDTELSWIFT- H 40TELMISARTAN + HYDROCHLOROTHIAZIDE40MG + 12.5MGIND SWIFT LTD-GLOBAL BUSINESS UNIT JAWAHARPUR OFF NH-21 DERABASSI DIST MOHALI PUNJAB 140507INDIAORAL SOLID ORDINARY TABLETS1.0X4.0X10.0 TABLET BLISTER
175NDA/MAL/HDP/0342IND SWIFT LTDPLANET PHARMACEUTICALS UGANDA LTDTELSWIFT- H 80TELMISARTAN + HYDROCHLOROTHIAZIDE80MG + 12.5MGIND SWIFT LTD-GLOBAL BUSINESS UNIT JAWAHARPUR OFF NH-21 DERABASSI DIST MOHALI PUNJAB 140507INDIAORAL SOLID ORDINARY TABLETS1.0X4.0X7.0 TABLET BLISTER
176NDA/MAL/HDP/0343GOOD DAY PHARMACY LIMITEDGOOD DAY PHARMACY LIMITEDWHITFIELD'S OINTMENT B.PBENZOIC ACID + SALICYLIC ACID6% W/W + 3% W/WKREMOINT PHARMA PVT LTD---B-8 ADDITIONAL AMBERNATH MIDC OPP. ANAND NAGAR POLICE CHECK POST AMBERNATH (E) DIST THANE 421 506INDIATOPICAL EXTERNAL OINTMENTS1.0X25.0 G TUBE
177NDA/MAL/HDP/0347MATRIX UGANDA LTDVITACARE LTDCHLORAMPHENICAL EYE DROPSCHLORAMPHENICAL EYE DROPS5MG/MLGRAND PHARMACEUTICAL(CHINA) CO.LTD-NO.5 GUTIAN ROAD QIAOKOU DISTRICT WUHAN CITY HUBEI PROVINCECHINAOPHTHALMIC DROPS1.0X1.0X10.0 ML BOTTLE
178NDA/MAL/HDP/0348ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDXBETABETAMETHASONE SODIUM PHOSPHATE0.1%W/VABACUS PARENTERAL DRUGS LIMITED-BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA.UGANDAOPHTHALMIC DROPS1.0X10.0 ML VIAL
179NDA/MAL/HDP/0349SWISS PARENTERALS PVT LTDSHREEJI PHARMACEUTICALS LIMITEDCLAXY 1.2 GCOAMOXICLAV1.2GSWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIAINDIAPARENTERAL ORDINARY DRY VIALS1.0X1.2 G VIAL
180NDA/MAL/HDP/0350RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDCETRIRENCETIRIZINE HYDROCHLORIDE10MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKAUGANDAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER
181NDA/MAL/HDP/0351MANKIND PHARM LTDTATA UGANDA LIMITEDDEPREGDINALEVONORGESTREL1.5MGACME FORMULATION PVT LTD.-ROPAR ROAD, NALAGARH, DIST. SOLAN, HIMACHAL PRADESH 174101 INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X1.0 TABLET BLISTER
182NDA/MAL/HDP/0354KOPRAN LIMITEDTATA UGANDA LIMITEDLEVOKOPLEVOFLOXACIN500MGKOPRAN LIMITED-VILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER
183NDA/MAL/HDP/0355SWISS PARENTERALS PVT. LTD.SHREEJI PHARMACEUTICALS LIMITEDBICO VITATHIAMINE HCL + RIBOFLAVIN + PYRIDOXINE HCL + NICOTINAMIDE10MG + 0.1MG + 1MG + 10MGSWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIAINDIAPARENTERAL ORDINARY AMPOULES1.0X10.0X2.0 ML AMPOULE
184NDA/MAL/HDP/0356DENK PHARMA GMBH & CO KGBENLE CONSULT LIMITEDLEVO DENK 50OLEVOFLOXACIN HEMIHYDRATE500MGROTTENDORF PHARMA GMBH-OSTENFELDER STRASSE 51-61 59320 ENNIGERLOH GERMANYGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X5.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER
185NDA/MAL/HDP/0358SWISS PARENTERALS PVT LTDSHREEJI PHARMACEUTICALS LIMITEDSTREPTOCINSTREPTOMYCIN SULPHATE1GMSWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIAINDIAPARENTERAL ORDINARY I M VIALS1.0X1.0 G VIAL
186NDA/MAL/HDP/0360ASTRA ZENECA ABMACNAUGHTON LIMITEDNEXIUM 20MGESOMEPRAZOLE20MGASTRAZENECA AB.-GARTUNA & SNACKVIKEN STOCKHOLMSWEDENORAL SOLID ORDINARY TABLETS1.0X4.0X7.0 TABLET BLISTER,1.0X7.0 TABLET BLISTER,1.0X14.0 TABLET CARTON
187NDA/MAL/HDP/0361I CARE PHARMA LIMITEDVITACARE LTDATROPINE INJECTIONATROPINEIMG/MLWUHAN GRAND PHARMACEUTICALS GROUP CO.LTD-M/S NO. 5 GUTIAN RD, WUHAN, HUBEI CHINACHINAPARENTERAL ORDINARY I V AMPOULES1.0X5.0X10.0 ML AMPOULE
188NDA/MAL/HDP/0362SWISS PARENTERALS PVT. LTD.SHREEJI PHARMACEUTICALS LIMITEDBUPIBUPIVACAINE5 MG/MLSWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIAINDIAPARENTERAL ORDINARY VIALS1.0X20.0 ML VIAL
189NDA/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 BLISTER
190NDA/MAL/HDP/0365UNIVERSAL CORPORATION LTDHARLEYS UGANDA LIMITEDSULFRAN- DSTRIMETHOPRIM/SULFAMETHOXAZOLE160MG/800MGUNIVERSAL CORPORATION LIMITED -PLOT 13777 KIKUYU ROAD, KIKUYU TOWN, PAST POST OFFICEKENYAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER
191NDA/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 BLISTER
192NDA/MAL/HDP/0367BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDBG-ZOLE -400ALBENDAZOLE400MGBLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIAINDIAORAL SOLID ORDINARY CHEWABLE TABLETS1.0X1.0 TABLET BLISTER
193NDA/MAL/HDP/0368ROTEX MEDICA GBH ARZNEIMITTELIGITTOES PHARMACEUTICALS LIMITEDQUININE DI HYDROCHLORIDE INJECTIONQUININE DIHYDROCHLORIDE300MG/MLROTEXMEDICA GMBH ARZEIMITTEL WERK-BUNSENSTRASSE 4, 22946 TRITTAUCHINAPARENTERAL ORDINARY AMPOULES1.0X10.0X2.0 ML AMPOULE
194NDA/MAL/HDP/0369ABBOT LABORATORIES S.A. (PTY) LTDHARLEYS UGANDA LIMITEDKLACID 250MGCLARITHROMYCIN250MGABBOTT LABORATORIES S.A (PTY) LTD-ABBOTT PLACE,219 GOLF CLUB
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195NDA/MAL/HDP/0370MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDNEBILONG-HNEBIVOLOL + HYDROCHLOROTHIAZIDE5MG + 12.5MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER
196NDA/MAL/HDP/0372UNICHEM LABORATORIES LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDLEZYNCETLEVOCETIRIZINE5MGUNICHEM LABORATORIES LIMITED-UNICHEM LABORATORIES LIMITED. UNIT II, VILLAGE BHATAULI KALAN, BADDI, DIST. SOLAN PIN CODE 173 205, HIMACHAL PRADESH, INDIA

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197NDA/MAL/HDP/0376EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDASOMEX-DAMLODIPINE + HYDROCHLOROTHIAZIDE2.5 MG + 12.5 MGEMCURE PHARMACEUTICALS LTD-LANE NO.3 PHASE II SIDCO INDUSTRIAL COMPLEX BARI BRAHMANA JAMMU (J&K) 18113INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER
198NDA/MAL/HDP/0379I CARE PHARMA LIMITEDVITACARE LTDAMINOPHYLLINE INJECTIONAMINOPHYLLINE250MG/10MLWUHAN GRAND PHARMACEUTICALS GROUP CO.LTD-M/S NO. 5 GUTIAN RD, WUHAN, HUBEI CHINACHINAPARENTERAL ORDINARY I V VIALS1.0X10.0X10.0 ML VIAL
199NDA/MAL/HDP/0381MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDEFAVIRENZ/EMTRICITABINE/TENOFOVIREFAVIRENZ + EMTRICITABINE + TENOFOVIR600MG + 200MG + 300MGMACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET BOTTLE
200NDA/MAL/HDP/0382FRESENIUS KABI MANUFACTURING S.A (PTY) LTDSURGIPHARM (U) LIMITEDKETAMINE FRESENIUSKETAMINE HYDROCHLORIDE50MG/MLFRESENIUS KABI MANUFACTURING SA (PTY) LTD-6 GIBAUD ROAD, KORSTEN 6020, PORT ELIZABETHSOUTH AFRICAPARENTERAL ORDINARY VIALS1.0X10.0X10.0 ML VIAL
201NDA/MAL/HDP/0383FRESENIUS KABI MANUFACTURING S.A (PTY) LTDSURGIPHARM (U) LIMITEDMANNITOL FRESENIUSMANNITOL20%W/VFRESENIUS KABI MANUFACTURING SA (PTY) LTD-6 GIBAUD ROAD, KORSTEN 6020, PORT ELIZABETHSOUTH AFRICAPARENTERAL ORDINARY INFUSION BAGS1.0X500.0 ML BAG
202NDA/MAL/HDP/0384FRESENIUS KABI MANUFACTURING S.A (PTY) LTDSURGIPHARM (U) LIMITEDPANCURONIUM BROMIDE FRESENIUSPANCURONIUM BROMIDE4MG/2MLFRESENIUS KABI MANUFACTURING SA (PTY) LTD-6 GIBAUD ROAD, KORSTEN 6020, PORT ELIZABETHSOUTH AFRICAPARENTERAL ORDINARY AMPOULES1.0X10.0X2.0 ML AMPOULE
203NDA/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 INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER
204NDA/MAL/HDP/0386EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDLOMOH-80ENOXAPARIN SODIUM80MG/ 0.8MLEMCURE PHARMACEUTICALS LTD -PLOT NO. P-1 ITBT PARK PHASE II MIDC HINJWADI PUNE 411057INDIAPARENTERAL ORDINARY PRE-FILLED SYRINGES1.0X1.0 ML PRE- FILLED SYRINGE
205NDA/MAL/HDP/0388KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDAZUCLOXAMPICILLIN + CLOXACILLIN250 MG + 250 MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALAUGANDAORAL SOLID ORDINARY CAPSULES1.0X10.0 CAPSULE STRIP,1.0X250.0 CAPSULE CONTAINER,1.0X1000.0 CAPSULE CONTAINER,1.0X500.0 CAPSULE CONTAINER,1.0X100.0X10.0 CAPSULE BLISTER
206NDA/MAL/HDP/0389PT SANBE FARMAMEDVIN PHARMA LIMITEDSANMOL INFUSION IVPARACETAMOL1000MG/100MLPT SANBE FARMA JI INDUSTRI-NO.8 KOMPLEKS INDUSTRI CIMAREME PADALARANG BANDUNGINDONESIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X100.0 ML BOTTLE
207NDA/MAL/HDP/0393NAARI LTDECHO PHARMACY (U) LIMITEDMISO-KAREMISOPROSTOL200MCGNAARI PHARMA PRIVATE LIMITED-PLOT NO. 14-16, 55-57, SECTOR-5, IIE, PANT NAGAR RUDRAPUR-263153 DIST-U.S. NAGAR UTTARAKHANDINDIAORAL SOLID ORDINARY TABLETS1.0X3.0X4.0 TABLET BLISTER
208NDA/MAL/HDP/0394LEBEN LABORATORIES PVT.LTDANDYCO PHARMACY (UGANDA) LTDDOXYLEBDOXYCYCLINE100MGLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER
209NDA/MAL/HDP/0397EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDASOMEX-LTAMLODIPINE + LOSARTAN POTASSIUM2.5 MG + 50 MGEMCURE PHARMACEUTICALS LTD-LANE NO.3 PHASE II SIDCO INDUSTRIAL COMPLEX BARI BRAHMANA JAMMU (J&K) 18113INDIAORAL SOLID ORDINARY TABLETS1.0X2.0X3.0X10.0 TABLET BLISTER
210NDA/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, INDIAINDIAORAL SOLID RETARD FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER
211NDA/MAL/HDP/0401FOURRTS (INDIA) LABORATORIES PVT LTDDELMAW ENTERPRISES LIMITEDL MONTUSLEVOCETIRIZINE HYDROCHLORIDE + MONTELUKAST SODIUM5MG + 10MGFOURRTS (INDIA) LABORATORIES (PVT) LTD-FOURRTS AVENUE, VANDALUR ROADINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET STRIP
212NDA/MAL/HDP/0402IVEE AQUA EPZ LTDASTRA PHARMA (U) LIMITEDIVYSONE OPHTHALMIC SUSPENSIONHYDROCORTISONE ACETATE1%W/VIVEE INFUSIONS EPZ LTD--LR NO.18474/84,ATHI RIVER BOX 25251 00100 NAIROBI KENYA ATHI RIVER,KENYAKENYAOPHTHALMIC SUSPENSIONS5.0 ML VIAL
213NDA/MAL/HDP/0403NEON LABARATORIES LTDAIVEEN (U) LIMITEDSUPRIDOLTRAMADOL HYDROCHLORIDE50MG/MLNEON LABORATORIES LTD --PLOT NO. 29, 30, 31, 32, 57 & 60, THE PALGHAR TALUKA - CO-OP ESTATE LTD., BOISAR ROAD, PALGHAR, DIST - THANE - 401404, MAHARASHTRAINDIAPARENTERAL ORDINARY I V AMPOULES1.0X2.0X5.0X1.0 ML AMPOULE
214NDA/MAL/HDP/0404GLAXOSMITH KLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDACTIFED WET COUGH & COLDTRIPLORIDINE HCL/PSEUDOEPHEDRINE/GUAIPHENESIN1.25MG/30MG/100MGGLAXO WELLCOME EGYPT SAE.-EL SALAM CITY 11491, CAIROEGYPTORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE,1.0X2.0 L JERRYCAN
215NDA/MAL/HDP/0405NEON LABARATORIES LTDAIVEEN (U) LIMITEDCHEMLETLETROZOLE2.5MGNEON LABORATORIES LTD-PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROADINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER
216NDA/MAL/HDP/0406NEON LABARATORIES LTDAIVEEN (U) LIMITEDEVATOCINOXYTOCIN10 I.U./ MLNEON LABORATORIES LTD-PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROADINDIAPARENTERAL ORDINARY I V AMPOULES1.0X2.0X5.0X1.0 ML AMPOULE
217NDA/MAL/HDP/0407NEON LABARATORIES LTDAIVEEN (U) LIMITEDNEOROFPROPOFOL1%W/VNEON LABORATORIES LTD --PLOT NO. 29, 30, 31, 32, 57 & 60, THE PALGHAR TALUKA - CO-OP ESTATE LTD., BOISAR ROAD, PALGHAR, DIST - THANE - 401404, MAHARASHTRAINDIAPARENTERAL ORDINARY I V AMPOULES1.0X20.0 ML AMPOULE
218NDA/MAL/HDP/0409NEON LABARATORIES LTDAIVEEN (U) LIMITEDTYDE-S*CHLORAMPHENICOL SODIUM SUCCINATE1G/VIALNEON LABORATORIES LTD --PLOT NO. 29, 30, 31, 32, 57 & 60, THE PALGHAR TALUKA - CO-OP ESTATE LTD., BOISAR ROAD, PALGHAR, DIST - THANE - 401404, MAHARASHTRAINDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0 G VIAL
219NDA/MAL/HDP/0411BAYER PHARMA AGSURGIPHARM (U) LIMITEDJADELLE SINELEVONORGESTREL150MGBAYER OY-PANSIONATE 47 20210 TURKU FINLANDFINLANDPARENTERAL RETARD IMPLANTS1.0X3.0X1.0 IMPLANT STRIP
220NDA/MAL/HDP/0413NEON LABARATORIES LTDAIVEEN (U) LIMITEDXSPASHYOSCINE BUTYLBROMIDE20MG/MLNEON LABORATORIES LTD --PLOT NO. 29, 30, 31, 32, 57 & 60, THE PALGHAR TALUKA - CO-OP ESTATE LTD., BOISAR ROAD, PALGHAR, DIST - THANE - 401404, MAHARASHTRAINDIAPARENTERAL ORDINARY I V AMPOULES1.0X2.0X5.0X1.0 ML AMPOULE
221NDA/MAL/HDP/0415MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDRELEXDIPHENHYDRAMINE HYDROCHLORIDE+AMMONIUM CHLORIDE+SODIUM CITRATE+MENTHOL14.03MG+138MG+57.03MG+0.90MGTORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506INDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE
222NDA/MAL/HDP/0416NOVARTIS PHARMA SERVICES INC.SURGIPHARM (U) LIMITEDRAMIZID 5RAMIPRIL5MGLEK S.A-95 - 010 STRYKÓW, PODLIPIE 16, POLANDPOLANDORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER
223NDA/MAL/HDP/0418ASTRA ZENECAMACNAUGHTON LIMITEDKOMBIGLYZE XR 5MG/1000SAXAGLIPTIN + METFORMIN5MG + 1000MGASTRAZENECA PHARMACEUTICALS LP.-4601 HIGHWAY 62 EAST MOUNT VERNON INDIANA 47620 USAUNITED STATESORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET BOTTLE
224NDA/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 BOTTLE
225NDA/MAL/HDP/0422AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDPARAFLAMIBUPROFEN + PARACETAMOL100MG + 162.5MG /5MLAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE
226NDA/MAL/HDP/0423AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOTRAMTRAMADOL50MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0X10.0 CAPSULE BLISTER
227NDA/MAL/HDP/0424COSMOS LTDASTRA PHARMA (U) LIMITEDCHLORPROMAZINE TABLETS B.P 25MGCHLORPROMAZINE25MGCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBIKENYAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER
228NDA/MAL/HDP/0426HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDLAMIVUDINE + ZIDOVUDINE + NEVIRAPINELAMIVUDINE + ZIDOVUDINE + NEVIRAPINE150MG +300MG + 200MGHETERO LABS LTD-22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESHINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X60.0 TABLET CONTAINER
229NDA/MAL/HDP/0427MICRO LABS LTDLABOREX UGANDA LIMITEDAMLOZAAR -HLOSARTAN POTASSIUM + AMLODIPINE BESILATE + HYDROCHLOROTHIAZIDE50MG + 5MG + 12.5MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER
230NDA/MAL/HDP/0428MICRO LABS LTDLABOREX UGANDA LIMITEDMICROMOX-400MOXIFLOXACIN400MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X5.0 TABLET BLISTER
231NDA/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 BLISTER
232NDA/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 INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X15.0X10.0 TABLET BLISTER
233NDA/MAL/HDP/0432FOURRTS (INDIA) LABORATORIES PVT LTDDELMAW ENTERPRISES LIMITEDK MAC ORAL SOLUTIONPOTASSIUM CITRATE + MAGNESIUM CITRATE22MG + 7.5MGFOURRTS INDIA LABORATORIES PVT. LIMITED-VANDALUR ROAD, KELAMBAKKAM 603103, CHENNAI, TAMIL NADU, INDIAINDIAORAL LIQUID ORDINARY LIQUIDS1.0X200.0 ML BOTTLE
234NDA/MAL/HDP/0433PT SAMBE FARMAMEDVIN PHARMA LIMITEDPROANES MCT/LCTPROPOFOL1%W/VPT SANBE FARMA JI INDUSTRI-NO.8 KOMPLEKS INDUSTRI CIMAREME PADALARANG BANDUNGINDONESIAPARENTERAL ORDINARY I V AMPOULES1.0X5.0X20.0 ML AMPOULE
235NDA/MAL/HDP/0434LEBEN LABORATORIES PVT LTDANDYCO PHARMACY (UGANDA) LTDPROHIBINOMEPRAZOLE20MGLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE STRIP
236NDA/MAL/HDP/0435FRESENIUS KABI MANUFACTURING S.A (PTY) LTDSURGIPHARM (U) LIMITEDLIGNOCAINE HCL FRESENIUSLIGNOCAINE HYDROCHLORIDE2%W/VFRESENIUS KABI MANUFACTURING SA (PTY) LTD-6 GIBAUD ROAD, KORSTEN 6020, PORT ELIZABETHSOUTH AFRICAPARENTERAL ORDINARY VIALS1.0X10.0X20.0 ML VIAL
237NDA/MAL/HDP/0436PT SANBE FARMAMEDVIN PHARMA LIMITEDSANBE HEST 130POLY (0-2-HYDROXYETHYL) STARCH30GPT SANBE FARMA-JI LEUIGAJAH NO. 162 CIMINDI, INDONESIAINDONESIAPARENTERAL ORDINARY INFUSION BAGS1.0X500.0 ML BOTTLE
238NDA/MAL/HDP/0437FRESENIUS KABI SOUTH AFRICA (PTY) LIMITEDSURGIPHARM (U) LIMITEDNALOXONE HCL NEONATAL FRESENIUSNALOXONE HYDROCHLORIDE0.02MG/MLFRESENIUS KABI MANUFACTURING SA (PTY) LTD-6 GIBAUD ROAD, KORSTEN 6020, PORT ELIZABETHSOUTH AFRICAPARENTERAL ORDINARY AMPOULES1.0X10.0X2.0 ML AMPOULE
239NDA/MAL/HDP/0438PT SANBE FARMAMEDVIN PHARMA LIMITEDSANBE HEST 200POLY (0-2-HYDROXYETHYL) STARCHMW 200,000PT SANBE FARMA-JI LEUIGAJAH NO. 162 CIMINDI, INDONESIAINDONESIAPARENTERAL ORDINARY INFUSION BAGS1.0X500.0 ML BOTTLE
240NDA/MAL/HDP/0439FRESENIUS KABI SOUTH AFRICA (PTY) LIMITEDSURGIPHARM (U) LIMITEDNALOXONE HCL FRESENIUS 0.4MG/1MLNALOXONE HYDROCHLORIDE0.4MG/1MLFRESENIUS KABI MANUFACTURING SA (PTY) LTD-6 GIBAUD ROAD, KORSTEN 6020, PORT ELIZABETHSOUTH AFRICAPARENTERAL ORDINARY AMPOULES1.0X10.0X1.0 ML AMPOULE
241NDA/MAL/HDP/0444FRESENIUS KABI MANUFACTURING S.A (PTY) LTDSURGIPHARM (U) LIMITEDNEOSTIGMINE METHYLSUIPHATE FRESENIUSNEOSTIGMINE METHYLSULPHATE2.5MG\MLFRESENIUS KABI MANUFACTURING SA (PTY) LTD-6 GIBAUD ROAD, KORSTEN 6020, PORT ELIZABETHSOUTH AFRICAPARENTERAL ORDINARY AMPOULES1.0X10.0X1.0 ML AMPOULE
242NDA/MAL/HDP/0449PHILLIPS PHARMACEUTICALS LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDAMINOGUARD GRANULESCYANOCOBALAMIN5MCGSTEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIAINDIAORAL SOLID ORDINARY GRANULES1.0X10.0X5.0 G SACHET
243NDA/MAL/HDP/0452I CARE PHARMA LIMITEDVITACARE LTDCALCIUM GLUCONATE INJECTIONCALCIUM GLUCONATE INJECTION1G/10MLGRAND PHARMACEUTICAL(CHINA) CO.LTD-NO.5 GUTIAN ROAD QIAOKOU DISTRICT WUHAN CITY HUBEI PROVINCECHINAPARENTERAL ORDINARY INFUSION AMPOULES1.0X10.0X10.0 ML AMPOULE
244NDA/MAL/HDP/0453PHILLIPS PHARMACEUTICALS LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDAMINOGUARD LIQUIDAMINO ACIDS + MULTIVITAMINSMULTI INGREDIENTSSTEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIAINDIAORAL LIQUID ORDINARY LIQUIDS1.0X200.0 ML BOTTLE
245NDA/MAL/HDP/0454PT SANBE FARMAMEDVIN PHARMA LIMITEDLEVOCIN INFUSIONLEVOFLOXACIN HEMIHYDRATE500 MGPT SANBE FARMA JI INDUSTRI-NO.8 KOMPLEKS INDUSTRI CIMAREME PADALARANG BANDUNGINDONESIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X100.0 ML BOTTLE
246NDA/MAL/HDP/0455I CARE PHARMA LIMITEDVITACARE LTDADRENALINE INJECTIONADRENALINE INJECTION1MG/1MLWUHAN GRAND PHARMACEUTICALS GROUP CO.LTD-M/S NO. 5 GUTIAN RD, WUHAN, HUBEI CHINACHINAPARENTERAL ORDINARY I V AMPOULES1.0X1.0X10.0X1.0 ML AMPOULE
247NDA/MAL/HDP/0456LEBEN LABORATORIES PVT. LTDANDYCO PHARMACY (UGANDA) LTDMETROLEBMETRONIDAZOLE125MG/5MLLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE
248NDA/MAL/HDP/0457UNIVERSAL CORPORATION LTDDELMAW ENTERPRISES LIMITEDUNIBROL 250MGAMINOSIDINE250MGUNIVERSAL CORPORATION LTD-UNIVERSAL CORPORATION LTDKENYAORAL SOLID ORDINARY TABLETS1.0X2.0X6.0 TABLET BLISTER, 1.0X4.0X6.0 TABLET BLISTER
249NDA/MAL/HDP/0460ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDAMBRODILAMBROXOL HYDROCHLORIDE7.5MG/MLARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO.II,MANDIDEEEP PRADESHINDIAORAL LIQUID ORDINARY LIQUIDS1.0X15.0 ML BOTTLE
250NDA/MAL/HDP/0463AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDTOPHENPHENYTOIN100MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0 CAPSULE CONTAINER,1.0X100.0X10.0 CAPSULE BLISTER
251NDA/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 STRIP
252NDA/MAL/HDP/0468NECTAR LIFESCIENCES LTDAIVEEN (U) LIMITEDCEFUAXIT 750CEFUROXIME750MGNECTAR LIFESCIENCES LIMITED-VILL. BHATOLIKALAN, ADJOININGJHARMJRI,
P.O BAROTIWALA DIST SOLAN H.P 173205
INDIAPARENTERAL ORDINARY DRY VIALS1.0X750.0 MG VIAL + 10ML WFI AMPOULE
253NDA/MAL/HDP/0470NOVO NORDISK PHARMA GULF FZ-LCPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDNOVOMIX 30 FLEXPENINSULIN ASPART100I.U/MLNOVO NORDISK A/S - NOVO ALLE DK-2880 BAGSVAERDDENMARKPARENTERAL ORDINARY DRY PRE-FILLED PENS1.0X5.0X3.0 ML PREFILLED PEN
254NDA/MAL/HDP/0471NOVO NORDISK PHARMA GULF FZ-LCPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDNOVORAPID FLEXPENINSULIN ASPART100 I.U/MLNOVO NORDISK A/S - NOVO ALLE DK-2880 BAGSVAERDDENMARKPARENTERAL ORDINARY PRE-FILLED PENS1.0X5.0X3.0 ML PREFILLED PEN
255NDA/MAL/HDP/0472SERUM INSTITUTE OF INDIA LTD.NORVIK ENTERPRISES LIMITEDBCG VACCINE (FREEZE DRIED)BCG VACCINE(FREEZE DRIED)1.33*100000 C.F.U/0.1MLSERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIAINDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0 ML VIAL,1.0X0.5 ML VIAL
256NDA/MAL/HDP/0475LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDTINI-500TINIDAZOLE500MGLINCOLN PHARMACEUTICALS LIMITED -10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X25.0X4.0 TABLET BLISTER
257NDA/MAL/HDP/0477LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDVOMISTAT-4ONDANSETRON4MGLINCOLN PHARMACEUTICALS LIMITED -10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER
258NDA/MAL/HDP/0480CIPLA LTDQUALITY CHEMICALS LTD - HUMANEFAVIRENZ, LAMIVUDINE & TENOFOVIR DISOPROXIL FUMERATE 600/300/300 MGEFAVIRENZ + LAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE600MG+300MG+300MGCIPLA QUALITY CHEMICAL INDUSTRIES LIMITED - -PLOT 1-7 1ST RING ROAD, LUZIRA, KAMPALA,CIPLA L.T.D -MIDC PATALGANGA MAHARASHTRA 410 220,CIPLA LTD UNIT VII PD II-S-103 TO S-105, S-107 TO S-112, L-138, L-147/1 TO L-147/3, L-147A, VERNA INDUSTRIAL ESTATE, VERNA SALCETTE, GOA 403722, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X30.0 TABLET CONTAINER
259NDA/MAL/HDP/0482LEBEN LABORATORIES PVT. LTDANDYCO PHARMACY (UGANDA) LTDAZILEB-500AZITHROMYCIN500MGLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X20.0X3.0 TABLET BLISTER
260NDA/MAL/HDP/0483FOUNTIL LIFE SCIENCES PVT LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDULGICID TABLETSALGINIC ACID+ MAGNESIUM HYDROXIDE+ ALUMINIUM HYDROXIDE+ MAGNESIUM TRISILICATE + SIMETICONE200MG + 250MG + 250MG + 250MG + 125MGSTEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIAINDIAORAL SOLID ORDINARY CHEWABLE TABLETS1.0X3.0X10.0 TABLET STRIP
261NDA/MAL/HDP/0484KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDPILPLAN PLUSETHINYL ESTRADIOL + LEVONORGESTREL / FERROUS FUMARATE0.03MG+0.15MG/75MGBAYER SCHERING PHARMA AG.-13342, BERLINGERMANYORAL SOLID ORDINARY TABLETS1.0X10.0X3.0X28.0 TABLET BLISTER
262NDA/MAL/HDP/0489LEBEN LABORATORIES PVT.LTDANDYCO PHARMACY (UGANDA) LTDCEBAY-200 DTCEFIXIME200MGLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL SOLID ORDINARY SOLUBLE TABLETS1.0X10.0 TABLET BLISTER
263NDA/MAL/HDP/0490SISONKELABOREX UGANDA LIMITEDORELOXCEFPODOXIME200MGSANOFI WINTHROP INDUSTRIE-SANOFI WINTHROP INDUSTRIE
56, RUE DE CHOISY AU BAC
60205 COMPIÈGNE
FRANCEORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER
264NDA/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 VIAL
265NDA/MAL/HDP/0493MSN LABORATORIES LTDPLANET PHARMACEUTICALS UGANDA LTDPRASUSAFE 10PRASUGREL10MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER
266NDA/MAL/HDP/0497LABORATORY&ALLIED LTDHARLEYS UGANDA LIMITEDKEMOXYL DRY SUSPENSIONAMOXYCILLIN TRIHYDRATE125MG/5MLLABORATORY & ALLIED LTD-PLOT NO. 209/10349
OFF MOMBASA ROAD, NAIROBI
P.O. BOX 42875, NAIROBI, KENYA.
KENYAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE
267NDA/MAL/HDP/0499NVS KENYA LTDSURGIPHARM (U) LIMITEDBANEOCIN OINTMENTBACITRACIN ZINC+NEOMYCIN SULPHATE250I.U + 5000I.UMERCK KGAA & CO.-HOSSLGASSE 20 9800 SPITTAL DRAU/ AUSTRIAAUSTRIATOPICAL EXTERNAL OINTMENTS1.0X20.0 G TUBE
268NDA/MAL/HDP/0507FOURRTS (INDIA) LABORATORIES PVT LTDDELMAW ENTERPRISES LIMITEDFILDILOL 12.5CARVEDILOL12.5 MGFOURRTS(INDIA) LABORATORIES PVT.LIMITED-VANDALUR ROAD,KELAMBAKKAM-603 103,
TAMIL NADU,INDIA
INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER
269NDA/MAL/HDP/0508ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDASTARGANPROMETHAZINE HYDROCHLORIDE25MGASTRA LIFE CARE (INDIA) PVT.LTD-PLOT 57/P, RAJODA-382220, BAVLA AHMEDABAD, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER
270NDA/MAL/HDP/0509FOURRTS (INDIA) LABORATORIES (PVT) LTDDELMAW ENTERPRISES LIMITEDFILDILOL 25CARVEDILOL25MGFOURRTS(INDIA) LABORATORIES PVT.LIMITED-VANDALUR ROAD,KELAMBAKKAM-603 103,
TAMIL NADU,INDIA
INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER
271NDA/MAL/HDP/0510GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDLIZOLID-600LINEZOLID600MGGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,DINDIAORAL SOLID ORDINARY TABLETS1.0X5.0X4.0 TABLET STRIP
272NDA/MAL/HDP/0512FOURRTS(INDIA) LABORATORIES PVT.LIMITEDDELMAW ENTERPRISES LIMITEDFILSTAT 10ATORVASTATIN CALCIUM10MGFOURRTS(INDIA) LABORATORIES PVT.LIMITED-VANDALUR ROAD,KELAMBAKKAM-603 103,
TAMIL NADU,INDIA
INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER
273NDA/MAL/HDP/0515FOURRTS(INDIA) LABORATORIES PVT.LIMITEDDELMAW ENTERPRISES LIMITEDFILSTAT 20ATORVASTATIN20MGFOURRTS(INDIA) LABORATORIES PVT.LIMITED-VANDALUR ROAD,KELAMBAKKAM-603 103,
TAMIL NADU,INDIA
INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER
274NDA/MAL/HDP/0517SANOFI AVENTIS KENYA LTDLABOREX UGANDA LIMITEDSHANVAC -BR- DNA HEPATITIS -B SURFACE ANTIGEN PURIFIED20MCG/MLSHANTHA BIOTECHNICS LTD -SURVEY NO. 274, ATHVELLI VILLAGE, MEDCHAL MANDAL – 501401, RANGA REDDY DISTRICT, ANDHRA PRADESH, INDIAINDIAPARENTERAL ORDINARY VIALS1.0X35.0X1.0 ML VIAL (1 ADULT DOSE),1.0X35.0X0.5 ML VIAL (1 PEDIATRIC DOSE)
275NDA/MAL/HDP/0518RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDCYCLORENACICLOVIR200MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET STRIP
276NDA/MAL/HDP/0520FOURRTS(INDIA) LABORATORIES PVT.LIMITEDDELMAW ENTERPRISES LIMITEDFILSTAT 40ATORVASTATIN CALCIUM40MGFOURRTS(INDIA) LABORATORIES PVT.LIMITED-VANDALUR ROAD,KELAMBAKKAM-603 103,
TAMIL NADU,INDIA
INDIAORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER
277NDA/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 BLISTER
278NDA/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
279NDA/MAL/HDP/0528ABACUS PARENTERAL DRUGS LIMITEDABACUS PHARMA (AFRICA) LIMITEDCLARY 500CLARITHROMYCIN500MGLINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARATINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER
280NDA/MAL/HDP/0529MANKIND PHARMA LIMITEDTATA UGANDA LIMITEDMOXIKIND-CVAMOXICILLIN + CLAVULANIC ACID200 MG + 28.5 MGMEDOPHARM PVT LTD -NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY-603203 TAMIL NADUINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML CONTAINER
281NDA/MAL/HDP/0531LEBEN LABORATORIES LTDANDYCO PHARMACY (UGANDA) LTDENDERM-GMCLOBETASOL PROPIONATE + GENTAMYCIN + MICONAZOLE NITRATE0.05%W/W + 0.10%W/W + 2.0%W/WLEBEN LABORATORIES PVT. LTD.-PLOT NO. L-4, PHASE –III, M.I.D.C, AKOLA, 444104, MAHARASHTRA, INDIA.INDIATOPICAL EXTERNAL CREAMS1.0X30.0 G TUBE,1.0X15.0 G TUBE
282NDA/MAL/HDP/0532ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDSARTAN-50LOSARTAN POTASSIUM50MGLINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARATINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER
283NDA/MAL/HDP/0534MANKIND PHARMA LIMITEDTATA UGANDA LIMITEDMOXIKIND-CV 375AMOXICILLIN + POTASSIUM CLAVULANATE250 MG + 125 MGMEDOPHARM PVT LTD.-NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADUINDIAORAL SOLID ORDINARY TABLETS1.0X2.0X6.0 TABLET BLISTER
284NDA/MAL/HDP/0536MANKIND PHARMA LIMITEDTATA UGANDA LIMITEDMOXIKIND-CV 625AMOXICILLIN + POTASSIUM CLAVULANATE500 MG + 125 MGMEDOPHARM PVT LTD.-NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADUINDIAORAL SOLID ORDINARY TABLETS1.0X2.0X6.0 TABLET BLISTER
285NDA/MAL/HDP/0538MICRO LABS LTDLABOREX UGANDA LIMITEDXONADINE 180FEXOFENADINE HYDROCHLORIDE180 MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER
286NDA/MAL/HDP/0540ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDHYDRICORTHYDROCORTISONE SODIUM SUCCINATE100MGLINCOLN PARENTERAL LTD-11, TRIMUL ESTATE, NEAR KHATRAJ CHOLADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARATINDIAPARENTERAL ORDINARY DRY VIALS1.0X50.0X100.0 MG VIAL
287NDA/MAL/HDP/0541MICRO LABS LTDLABOREX UGANDA LIMITEDXONADINE 120FEXOFENADINE HYDROCHLORIDE120MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER
288NDA/MAL/HDP/0542DAWA LIMITEDSUPER MEDIC LTDPHENBITALPHENOBARBITAL30MGDAWA LTD-BABA DOGO ROAD RUARAKAKENYAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER
289NDA/MAL/HDP/0544MICRO LABS LIMITEDLABOREX UGANDA LIMITEDDOLOWIN PLUSACECLOFENAC + PARACETAMOL100 MG + 500 MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER
290NDA/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 CONTAINER
291NDA/MAL/HDP/0551SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDREDAMOXAMOXICILLIN + CLAVULANIC ACID125 MG/ 5 ML + 31.25 MG/ 5 MLSAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIAINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE
292NDA/MAL/HDP/0553BHARAT SERUMS AND VACCINES LTDGITTOES PHARMACEUTICALS 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)
293NDA/MAL/HDP/0554ABACUS PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDINDOCAP-25INDOMETHACIN25 MGSHANDONG XIER KANGTAI PHARMACEUTICALS CO. LTD PRIVATE-PRIVATE ECONOMY ZONE,XINYAN TOWN, YANZHOU DISTRICT, JINING CITY,SHANDONG,CHINA PRCHINAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER
294NDA/MAL/HDP/0557SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDREDAMOX 312.5AMOXICILLIN + POTASSIUM CLAVULANATE250 MG/5 ML + 62.5 MG/5 MLSAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIAINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE
295NDA/MAL/HDP/0558ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDABGENTA EYE DROPSGENTAMICIN SULPHATE0.3% W/VABACUS PARENTERAL DRUGS LIMITED-BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA.UGANDAOPHTHALMIC DROPS1.0X10.0 ML BOTTLE
296NDA/MAL/HDP/0562KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAM COTRICO-TRIMOXAZOLE240MG/5MLKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALAUGANDAORAL LIQUID ORDINARY SUSPENSIONS100.0 ML BOTTLE,60.0 ML BOTTLE
297NDA/MAL/HDP/0563IND SWIFT LTDPLANET PHARMACEUTICALS UGANDA LTDEZO 40ESOMEPRAZOLE MAGNESIUM40MGIND-SWIFT-LTD,-GLOBAL BUSINESS UNIT, JAWAHARPUR, OFF NH-21 DERABASSIINDIAORAL SOLID RETARD TABLETS1.0X10.0X10.0 TABLET BLISTER
298NDA/MAL/HDP/0565YURIA PHARM LTDYURIA PHARM EAST AFRICA LIMITEDAMINOCAPROIC ACID-UFAMINOCARPROIC ACID5G/100MLYURIA-PHARM, LTD.-18030 VERBOVETSKOGO STR. 108 CHERKASSY, UKRAINE.UKRAINEPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X100.0 ML BOTTLE
299NDA/MAL/HDP/0566SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDCEFROTIL SUSPENSIONCEFUROXIME AXETIL125MG/5MLSAKAR HEALTHCARE PVT. LTD-PLOT 10/13 SAKHEJ-BAVLA ROAD, AHMEDABAD,GUJURAT,INDIAINDIAORAL LIQUID ORDINARY SOLUBLE POWDERS1.0X1.0X50.0 ML BOTTLE
300NDA/MAL/HDP/0568RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDFLUOXIRENFLUOXETINE20MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKAUGANDAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER
301NDA/MAL/HDP/0570BHARAT SERUMS AND VACCINES LIMITED,GITTOES PHARMACEUTICALS 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)
302NDA/MAL/HDP/0572NORVATIS PHARMA AG- SWITZERLANDLABOREX UGANDA LIMITEDAZARGABRINZOLAMIDE + TIMOLOL10MG/ML + 5MG/MLALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUMBELGIUMOPHTHALMIC DROPS1.0X5.0 ML VIAL
303NDA/MAL/HDP/0575MICRO LABS LTDLABOREX UGANDA LIMITEDMICROMOXMOXIFLOXACIN400MG/100MLAHLCON PARENTERALS (INDIA) LTD-SP-917-918, PHASE-III BHIWADI-301019, ALWAR, RAJASTHANINDIAPARENTERAL ORDINARY INFUSION BAGS1.0X100.0 ML BOTTLE
304NDA/MAL/HDP/0576GLAXO SMITH KLINE LTDERIS LTDDUODARTDUTASTERIDE + TAMSULOSIN0.5MG + 0.4MGCATALENT GERMANY SCHONDORF GMBH -STEINBEISSTRASSE 1-2, 73614 SCHORNDORF, GERMANYGERMANYORAL SOLID ORDINARY CAPSULES1.0X30.0 CAPSULE CONTAINER
305NDA/MAL/HDP/0580KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDFLUCAPMULTINGREDIENTMULTINGREDIENTKAMPALA PHARMECEUTICALS INDUSTRIES LTD.-PLOT M444B STRETCHER RD, NTINDA KLA UGANDAUGANDAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER
306NDA/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 BLISTER
307NDA/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 BLISTER
308NDA/MAL/HDP/0586CADILA PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.ONSETTONDANSETRON2MG/MLCADILA PHARMACEUTICALS LTD-1389 DHOLKA 387 810 DIST AHMEDABAD GUJARATINDIAPARENTERAL ORDINARY AMPOULES1.0X5.0X2.0 ML AMPOULE,1.0X5.0X4.0 ML AMPOULE
309NDA/MAL/HDP/0587CADILA PHARMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.CADIGRELCLOPIDOGREL75MGCADILA PHARMACEUTICALS LTD-1389 DHOLKA 387 810 DIST AHMEDABAD GUJARATINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER
310NDA/MAL/HDP/0588AUROLABSWASTIK PHARMACEUTICAL LTDAUROFORTPREDNISOLONE ACETATE1%W/VAUROLAB-NO 1 SIVAGANGAI MAIN ROAD, VEERAPANJAN MADURAI – 625 020 TAMIL NADU, INDIAINDIAOPHTHALMIC SUSPENSIONS1.0X5.0 ML BOTTLE
311NDA/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 BLISTER
312NDA/MAL/HDP/0590BHARAT SERUMS AND VACCINES LTDGITTOES PHARMACEUTICALS 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 VIAL
313NDA/MAL/HDP/0592AUROLABSWASTIK PHARMACEUTICAL LTDAUROCHROMECROMOLYN SODIUM2%W/VAUROLAB-NO 1 SIVAGANGAI MAIN ROAD, VEERAPANJAN MADURAI – 625 020 TAMIL NADU, INDIAINDIAOPHTHALMIC LIQUIDS1.0X10.0 ML CONTAINER
314NDA/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 STRIP
315NDA/MAL/HDP/0594AUROLABSWASTIK PHARMACEUTICAL LTDAUROVISC-2ML PFSHYPROMELLOSE OPHTHALMIC SOLUTION USP2%W/VAUROLAB.-SIVAGANGAI MAIN ROAD, VEERAPANJAN, MADURAI 625 020 TAMIL INDIAINDIAOPHTHALMIC VIALS1.0X2.0 ML PRE- FILLED SYRINGE
316NDA/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 BLISTER
317NDA/MAL/HDP/0596MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDARBITEL-HTELMISARTAN/HYDROCHLOROTHIAZIDE40MG/12.5MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET STRIP
318NDA/MAL/HDP/0598INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDLIPICURE-20ATORVASTATIN20MGINTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER
319NDA/MAL/HDP/0599MICRO LABS LTDLABOREX UGANDA LIMITEDGRAMOCEF-O-400CEFIXIME400MGMICROLABS LIMITED-PLOT NO. 121-124, KIADB, BOMMASANDRA , -JIGNI LINK ROAD, ANEKUL TALUK,BANGALORE, KARNATAKA, INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X6.0 TABLET BLISTER
320NDA/MAL/HDP/0600DENK PHARM GMBH&CO.KGBENLE CONSULT LIMITEDCARVEDI-DENK 6.25CARVEDILOL6.25MGARTESAN PHARMA GMBH & CO. KG -WENDLANDSTRABE 1,29439 LUCHOW,GERMANYGERMANYORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER
321NDA/MAL/HDP/0605DENK PHARM GMBH&CO.KGBENLE CONSULT LIMITEDCARVEDI-DENK 25CARVEDILOL25MGARTESAN PHARMA GMBH & CO. KG -WENDLANDSTRABE 1,29439 LUCHOW,GERMANYGERMANYORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER
322NDA/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 BOTTLE
323NDA/MAL/HDP/0609DENK PHARMA GMBH & CO KGBENLE CONSULT LIMITEDCLOPI-DENK 75CLOPIDOGREL BESYLATE75MGARTESAN PHARMA GMBH & CO. KG -WENDLANDSTRABE 1,29439 LUCHOW,GERMANYGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER
324NDA/MAL/HDP/0610ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDPYLOR KITLANSOPRAZOLE DELAYED RELEASE + CLARITHROMYCIN+ TINIDAZOLE30MG + 250MG + 500MGLINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARATINDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X7.0X1.0X6.0 TABLET BLISTER (BLISTER CONTAINS 2 CAPSULES AND 4 TABLETS)
325NDA/MAL/HDP/0611GALPHAR LABORATORIES LTDAIVEEN (U) LIMITEDGALCIPRO 500CIPROFLOXACIN HYDROCHLORIDE500MGGALPHA LABORATORIES LIMITED-VILLAGE – THANA BADDI, TEHSIL BADDI
SOLAN HIMACHAL PRADESH-173 205 INDIA
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER
326NDA/MAL/HDP/0614GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDCLAVULINAMOXICILLIN + CLAVULANIC ACID126 MG/ 5 ML + 31.25 MG/ 5 MLSMITHKLINE BEECHAM PHARMACEUTICALS,-CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QHUNITED KINGDOMORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X70.0 ML BOTTLE,1.0X100.0 ML BOTTLE
327NDA/MAL/HDP/0615HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDVALSAR 80VALSARTAN80MGHETERO LABS LTD. UNIT (V)-S.N0.439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE),
JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER
328NDA/MAL/HDP/0617ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDSILVEXSILVER SULFADIAZINE + CHLORHEXIDINE1%W/W + 0.2%W/WLINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARATINDIATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE
329NDA/MAL/HDP/0618HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDVALSAR 160VALSARTAN160MGHETERO LABS LTD. UNIT (V)-439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE),
JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA.
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER
330NDA/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 BOTTLE
331NDA/MAL/HDP/0621HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDALZERDONEPEZIL HYDROCHLORIDE10MGHETERO LABS LTD. UNIT (V)-439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE),
JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA.
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER
332NDA/MAL/HDP/0623ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDGELCIDMAGNESIUM SULPHATE50%W/VLINCOLN PHARMACEUTICALS LTD--11 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARATINDIAPARENTERAL ORDINARY AMPOULES1.0X10.0X5.0X10.0 ML AMPOULE,1.0X10.0X5.0X5.0 ML AMPOULE IN BLISTER PACK
333NDA/MAL/HDP/0625SANOFI PASTEURLABOREX UGANDA LIMITEDVERORABRABIES VACCINE1 DOSESANOFI PASTEUR-1541 AVENUE MARCEL MERIEUX, 69280 MARCY, LETOILEFRANCEPARENTERAL ORDINARY VIALS1.0X1.0 DOSE VIAL
334NDA/MAL/HDP/0626KPI INDUSTRIES(1996) LTEDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDCARDIPAC-10AMLODIPINE BESILATE10MGKPI INDUSTRIES (1996) LTD-PLOT NO.M444B STRETCHER RD, NTINDA, KAMPALAUGANDAORAL SOLID ORDINARY TABLETS1.0X1.0X10.0X10.0 TABLET BLISTER
335NDA/MAL/HDP/0627KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDAMOXIKIDAMOXICILLIN TRIHYDRATE125MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD-PLOT M 444B STRETCHER ROAD NTINDAUGANDAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET STRIP,1.0X2.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER
336NDA/MAL/HDP/0630CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDNEO LORIDINDESLORATADINE5MGCADILA HEALTHCARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO.203-213, KUNDAIM GOA, 403115, INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER
337NDA/MAL/HDP/0633ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDCIPROCINCIPROFLOXACIN0.3%W/VABACUS PARENTERAL DRUGS LTD-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE,
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UGANDAOPHTHALMIC DROPS1.0X10.0 ML VIAL
338NDA/MAL/HDP/0635AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGO-AMINAMINOPHYLLINE100MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER
339NDA/MAL/HDP/0636MYLAN LABORATORIES LIMITED.NORVIK ENTERPRISES LIMITEDREVOKE-1.5LEVONORGESTREL1.5MGMYLAN LABORATORIES LIMITED.--PLOT NO. 1606-1609, SARIGAM INDUSTRIAL AREA, GIDC, SARIGAM, TAL-UMERGAM, DIST VALSAD, 396155, GUJARAT, INDIA.,MYLAN LABORATORIES LIMITED..-PLOT NO.20 & 21, PHARMEZ, SARKHEJ-BAVLA NATIONAL HIGHWAY NO. 08A, NEAR VILLAGE MATODA, TAL-SANAND, AHMEDABAD, GUJARAT, INDIA 382213INDIAORAL SOLID ORDINARY TABLETS1.0X1.0 TABLET BLISTER
340NDA/MAL/HDP/0637NABIQASIM INDUSTRIES (PVT) LIMITEDJEET PHARMACEUTICALS LIMITEDZUDICORTFUSIDIC ACID + BETAMETHASONE VALERATE20MG + 1MG/GNABIQASIM INDUSTRIES (PVT) LIMITED-17/24, KORANGI INDUSTRIAL AREA, KARACHI, PAKISTANPAKISTANTOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE
341NDA/MAL/HDP/0638ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDABLOL-5 EYE DROPSTIMOLOL MALEATE0.5% W/VABACUS PARENTERAL DRUGS LTD-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE,
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342NDA/MAL/HDP/0639NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDRHEUMATIC CREAMMULTI-INGREDIENTMULTI-INGREDIENTNEM LABORATORIES PVT LTD-133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAIINDIATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE
343NDA/MAL/HDP/0640SANDOZ KENYA C/O NOVARTIS PHARMA SERVICES INCSURGIPHARM (U) LIMITEDBIODROXIL 250MG/5MLCEFADROXIL (ANHYDROUS)250MG/5MLSANDOZ GMBH-BIOCHEMIESTRASSE 10, A6250 KUNDL, TYROL, AUSTRIA AUSTRIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X60.0 ML BOTTLE
344NDA/MAL/HDP/0641ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDGYNAZOLECLOTRIMAZOLE2%W/WLINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARATINDIATOPICAL EXTERNAL CREAMS1.0X30.0 G TUBE
345NDA/MAL/HDP/0643NAARI AGECHO PHARMACY (U) LIMITEDMISOPROMISOPROSTOL200MCGNAARI PHARMA PRIVATE LIMITED-PLOT NO. 14-16, 55-57, SECTOR-5, IIE, PANT NAGAR RUDRAPUR-263153 DIST-U.S. NAGAR UTTARAKHANDARGENTINAORAL SOLID ORDINARY TABLETS1.0X4.0 TABLET BLISTER
346NDA/MAL/HDP/0651SANDOZ KENYA C/O NOVARTIS PHARMA SERVICES INCSURGIPHARM (U) LIMITEDBIODROXIL 500MGCEFADROXIL (ANHYDROUS)500MGSANDOZ GMBH-BIOCHEMIESTRASSE 10, A6250 KUNDL, TYROL, AUSTRIA AUSTRIAORAL SOLID ORDINARY CAPSULES1.0X2.0X6.0 CAPSULE BLISTER
347NDA/MAL/HDP/0652NVS KENYA LTDSURGIPHARM (U) LIMITEDGALVUSVILDAGLIPTIN50MGNOVARTIS PHARMA STEIN AG-SCHAFFHARVSERTRASSE CH-4332 STEIN SWITZERLAND.,NOVARTIS BARBERA -SPAINSWITZERLANDORAL SOLID ORDINARY TABLETS1.0X4.0X14.0 TABLET BLISTER
348NDA/MAL/HDP/0654NVS KENYA LTDSURGIPHARM (U) LIMITEDGALVUS METVILDAGLIPTIN / METFORMIN50MG/500MGNORVATIS PHARMA PRODUCTIONS GMBH, WEHR-GERMANYGERMANYORAL SOLID ORDINARY TABLETS1.0X60.0 TABLET CONTAINER
349NDA/MAL/HDP/0657NVS KENYA LTDSURGIPHARM (U) LIMITEDGALVUS METVILDAGLIPTIN / METFORMIN50MG / 850MGNORVATIS PHARMA PRODUCTIONS GMBH, WEHR-GERMANYGERMANYORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X6.0X10.0 TABLET BLISTER
350NDA/MAL/HDP/0658NVS KENYA LTDSURGIPHARM (U) LIMITEDGALVUS METVILDAGLIPTIN/ METFORMIN50MG/1000MGNORVATIS PHARMA PRODUCTIONS GMBH, WEHR-GERMANYGERMANYORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X6.0X10.0 TABLET BLISTER
351NDA/MAL/HDP/0662PHARMAVET LTDDELMAW ENTERPRISES LIMITEDRECTIN 100INDOMETHACIN100MGBLISS GVS PHARMA LTD-PLOT.NO 10,SURVEY NO 38/1,DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR, TAL: PALGHAR DIST.THANE, MAHARASHTRA-INDIAINDIARECTAL SYSTEMIC ADULT SUPPOSITORIES1.0X2.0X5.0 SUPPOSITORY STRIP
352NDA/MAL/HDP/0663BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDGLYCERINGLYCERIN1GBLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIAINDIARECTAL SYSTEMIC ADULT SUPPOSITORIES1.0X5.0 SUPPOSITORY STRIP
353NDA/MAL/HDP/0665HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDIRBIS 150IRBESARTAN150MGHETERO LABS LTD (UNIT-V)-SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X1.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER
354NDA/MAL/HDP/0666HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDIRBIS-H 300IRBESARTAN300MGHETERO LABS LTD (UNIT-V)-SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X1.0X10.0 TABLET BLISTER
355NDA/MAL/HDP/0668CADILA PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.TELI 40TELMISARTAN40MGCADILA PHARMACEUTICALS LTD.-1389, TRASAD ROAD, DHOLKA 387810 DISTRICT AHMEDABAD GUJARAT STATEINDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER
356NDA/MAL/HDP/0670AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDFLUNAZ-200FLUCONAZOLE200MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIAORAL SOLID ORDINARY CAPSULES1.0X4.0 CAPSULE BLISTER,1.0X5.0X4.0 CAPSULE BLISTER
357NDA/MAL/HDP/0672AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGONOR TABLETSNORFLOXACIN400MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER
358NDA/MAL/HDP/0674AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGODAPS-100DAPSONE100MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER
359NDA/MAL/HDP/0676CADILA PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.ONSETT 4ONDANSETRON4MGCADILA PHARMACEUTICALS LTD-1389 DHOLKA 387 810 DIST AHMEDABAD GUJARATINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER
360NDA/MAL/HDP/0677AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDDOPAMETMETHYLDOPA250MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER
361NDA/MAL/HDP/0679AGOG PHARMAGITTOES PHARMACEUTICALS LIMITEDMEFENA-250 CAPSULESMEFENAMIC ACID250MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY OTHER CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0X10.0 CAPSULE BLISTER
362NDA/MAL/HDP/0681GENNOVA BIOPHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDELAXIM 40TENECTEPLASE (RECOMBINANT TISSUE PLASMINOGEN ACTIVATOR)40MG/VIALEMCURE PHARMACEUTICALS LTD .-PLOT NO. P-2 IT-BT PARK PHASE II MIDC HINJWADI PUNE 411057INDIAPARENTERAL ORDINARY DRY VIALS1.0X40.0 MG VIAL , 1*8 ML VIAL OF WFI
363NDA/MAL/HDP/0685FERRER INTERNACIONAL S.ALABOREX UGANDA LIMITEDSOMAZINACITICOLINE1000MGFERRER INTERNACIONAL S.A --GRAN VIA CARLOS III 94 08028 BARCELONASPAINPARENTERAL RETARD I M AMPOULES1.0X5.0X4.0 ML AMPOULE
364NDA/MAL/HDP/0687FERRER INTERNACIONAL S.ALABOREX UGANDA LIMITEDSOMAZINACITICOLINE1000MGFERRER INTERNACIONAL S.A --GRAN VIA CARLOS III 94 08028 BARCELONASPAINORAL LIQUID ORDINARY LIQUIDS1.0X6.0X10.0 ML SACHET
365NDA/MAL/HDP/0688AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDHBBHYOSCINE BUTYLBROMIDE10MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY COATED TABLETS1.0X10.0X10.0 TABLET BLISTER
366NDA/MAL/HDP/0689AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGONALNALIDIXIC ACID500MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER
367NDA/MAL/HDP/0690MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDHEALTHEASE CREAMBECLOMETHASONE DIPROPRIONATE + PHENYLEPHRINE HCL + LIGNOCAINE HCL + CHLOROCRESOL0.025%W/W + 0.1%W/W + 2.5%W/W + 0.1%W/WTORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506INDIATOPICAL EXTERNAL CREAMS1.0X30.0 G TUBE
368NDA/MAL/HDP/0691MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDOLMAT-20OLMESARTAN MEDOXOMIL20 MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER
369NDA/MAL/HDP/0692DAWA LIMITEDSUPER MEDIC LTDDAWACLOX -250CLOXACILLIN SODIUM250MGDAWA LIMITED -BABA DOGO RWARAKAKENYAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER
370NDA/MAL/HDP/0693DAWA LIMITEDSUPER MEDIC LTDMOXACIL -250AMOXYCILLIN TRIHYDRATE250MGDAWA PHARMACEUTICALS LIMITED-PLOT 7879, BABA DOGO ROAD RUARAKAKENYAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER
371NDA/MAL/HDP/0694AGOG PHARMA LTD.GITTOES PHARMACEUTICALS LIMITEDDT ZINC-20 TABLETSZINC SULPHATE20MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIAORAL SOLID ORDINARY SOLUBLE TABLETS1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET CARTON
372NDA/MAL/HDP/0696HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDRITONAVIRRITONAVIR100MGHETERO LABS LTD-22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESHINDIAORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET CONTAINER
373NDA/MAL/HDP/0698ELYS CHEMICAL INDUSTRIES LTDVELVET PHARMA LIMITEDWHITFIELD'S OINTMENTBENZOIC ACID+SALICYLIC CID6%W/W + 3%W/WELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBIKENYATOPICAL EXTERNAL OINTMENTS1.0X20.0 G TUBE
374NDA/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 382210INDIAPARENTERAL ORDINARY VIALS1.0X1.0 ML VIAL + 1ML AMPOULE OF WFI(1 DOSE VIAL)
375NDA/MAL/HDP/0702ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDSEPTOCINSTREPTOMYCIN SULPHATE1GMREYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100CHINAPARENTERAL ORDINARY DRY VIALS1.0X50.0X1.0 G VIAL
376NDA/MAL/HDP/0703GOOD DAY PHARMACY LIMITEDGOOD DAY PHARMACY LIMITEDDICLODAY GELDICLOFENAC DIETHYLAMINE+ LINSEED OIL+ METHYL SALICYLATE +MENTHOL11.6MG + 30MG + 100MG + 50MGKREMOINT PHARMA PVT LTD---B-8 ADDITIONAL AMBERNATH MIDC OPP. ANAND NAGAR POLICE CHECK POST AMBERNATH (E) DIST THANE 421 506INDIATOPICAL EXTERNAL GELS AND SOLS1.0X30.0 G TUBE
377NDA/MAL/HDP/0704HETERO LABS LTD UNIT IXABACUS PHARMA (AFRICA) LIMITEDM-FLOXMOXIFLOXACIN HYDROCHLORIDE400MGHETERO LABS LTD (UNIT-V)-SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIA,HETERO LABS LTD-UNIT II & III BADDI THE NALAGARH DIST SOLAN H.PINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER,10.0X1.0X5.0 TABLET BLISTER
378NDA/MAL/HDP/0705LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDACICLOVIRACICLOVIR5%W/WLINCOLN PHARMACEUTICAL LIMITED-TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIAINDIATOPICAL EXTERNAL CREAMS1.0X10.0 G TUBE
379NDA/MAL/HDP/0706INTAS PHARMACEUTICALS LIMITEDNORVIK ENTERPRISES LIMITEDROVAS 5ROSUVASTATIN5MGINTAS PHARMACEUTICALS LIMITED -CAMP ROAD, SELAQUI-248197,DEHRADUN UTTARAKHAND, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER
380NDA/MAL/HDP/0707HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDPENVIR 500FAMCICLOVIR500MGHETERO LABS LTD(UNIT V).-JADCHERLA (M),MAHABOOBNAGAR DIST, ANDHRA PRADESH,INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER
381NDA/MAL/HDP/0710INTAS PHARMACEUTICALS LIMITEDNORVIK ENTERPRISES LIMITEDROVAS 20ROSUVASTATIN20MGINTAS PHARMACEUTICALS LIMITED -CAMP ROAD, SELAQUI-248197,DEHRADUN UTTARAKHAND, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER
382NDA/MAL/HDP/0712GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDZENTELALBENDAZOLE100MG/5MLFARMACLAIR -440 AVENUE DU GENERAL DE GAULLE 14200 HEROUVILLE SAINT CLAIR FRANCEFRANCEORAL LIQUID ORDINARY SUSPENSIONS1.0X20.0 ML BOTTLE
383NDA/MAL/HDP/0713DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDPANTO-DENK 20PANTOPRAZOLE SODIUM SESQUIHYDRATE20MGADVANCE PHARMA GMBH..-WALLENRODER STR.12-14, 13435 BERLINGERMANYORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X2.0X14.0 TABLET BLISTER
384NDA/MAL/HDP/0715DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDPANTO-DENK 40PANTOPRAZOLE SODIUM SESQUIHYDRATE40MGADVANCE PHARMA GMBH..-WALLENRODER STR.12-14, 13435 BERLINGERMANYORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X2.0X14.0 TABLET BLISTER
385NDA/MAL/HDP/0716LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDGLYMET-1GLIMEPIRIDE+METFORMIN HYDROCHLORIDE1MG + 500MGLINCOLN PHARMACEUTICALS L.T.D-TRIMUL ESTATE KHATRAJ 382721 GHANDINAGAR GUJARATINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER
386NDA/MAL/HDP/0718LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDGLYMET-2GLIMEPIRIDE+METFORMIN HYDROCHLORIDE2MG + 500MGLINCOLN PHARMACEUTICALS L.T.D-TRIMUL ESTATE KHATRAJ 382721 GHANDINAGAR GUJARATINDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X5.0X10.0 TABLET BLISTER
387NDA/MAL/HDP/0719WOCKHARDT LTDSTAR PHARMACEUTICALS LTDWEPOX 4000RECOMBINANT HUMAN ERYTHROPOIETIN4000 I.UWOCKHARDT LIMITED --WOCKHARDT BIOTECH PARK, H14/2, M.I.D.C, WALUJ, AURANGABAD 431136 MAHARASHTRA INDIAINDIAPARENTERAL ORDINARY PRE-FILLED SYRINGES1.0X0.4 ML PRE- FILLED SYRINGE
388NDA/MAL/HDP/0721MISSION PHARMAMETRO PHARMACEUTICALS LIMITEDARH-AARTEMETHER80MG/MLLINCOLN PARENTERAL LTD-11, TRIMUL ESTATE, NEAR KHATRAJ CHOLADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARATINDIAPARENTERAL ORDINARY I M AMPOULES1.0X2.0X3.0X1.0 ML AMPOULE,1.0X1.0X6.0 ML AMPOULE
389NDA/MAL/HDP/0722FDC LTDAIVEEN (U) LIMITEDIOTIM 0.5%TIMOLOL MALEATE0.5% W/VFDC LIMITED -B-8, M.I.D.C., INDUSTRIAL AREA, WALUJ – AURANGABAD- 431 136 MAHARASHTRA, INDIA. INDIAOPHTHALMIC DROPS1.0X5.0 ML BOTTLE
390NDA/MAL/HDP/0725TROIKAA PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDSPASMOTROY 40DROTAVERINE HYDROCHLORIDE40MG TROIKAA PHARMACEUTICALS LTD .-SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHAND, INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER
391NDA/MAL/HDP/0726TROIKAA PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDT DOL RAPIDTRAMADOL HYDROCHLORIDE50MGTROIKAA PHARMACEUTICALS LTD- SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHANDINDIAORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS1.0X10.0X10.0 TABLET STRIP
392NDA/MAL/HDP/0727MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDSTOMACH FIT SYRUPBISMUTH AMMONIUM CITRATE+BELLADONA DRY EXTRACT+THYMOL+MENTHOL140MG+9MG+0.15MG+0.2/5MLTORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506INDIAORAL LIQUID ORDINARY LIQUIDS1.0X225.0 ML BOTTLE
393NDA/MAL/HDP/0737SANOFI AVENTISLABOREX UGANDA LIMITEDTAXOTERE 80MGDOCETAXEL TRIHYDRATE80MG/4MLSANOFI-AVENTIS DEUTSCHLAND GMBH -INDUSTRIEPARK HOECHST, BRUNINGSTRASSEN, BUILDING
H650 65926 FRANKFURT AM MAIN, GERMANY
GERMANYPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X4.0 ML VIAL
394NDA/MAL/HDP/0738INDOCO REMEDIES LIMITEDTATA UGANDA LIMITEDCIPRIND-500CIPROFLOXACIN500MGINDOCO REMEDIES LTD-B-20, MIDC, WALUJ, AURANGABAB 431136 INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X5.0X200.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER
395NDA/MAL/HDP/0739SANOFI AVENTISLABOREX UGANDA LIMITEDTAXOTERE 20MGDOCETAXEL TRIHYDRATE20MG/MLSANOFI-AVENTIS DEUTSCHLAND GMBH-INDUSTRIEPARK HOESCHST,BRUNINGSTRASSEN BUIDING,H65065926, FRANKFURT AM MAINGERMANYPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X1.0 ML VIAL
396NDA/MAL/HDP/0745CADILA PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.TELI 80TELMISARTAN80MGB. BRAUN MELSUNGEN - MISTELWEG-1389, TRABAD ROAD, DHOLKA 387 810, DISTRICT AHMEDABAD, GUJARAT, INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER
397NDA/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 BLISTER
398NDA/MAL/HDP/0748BAYER PHARMASURGIPHARM (U) LIMITEDXARELTO 15MGRIVAROXABAN15MGBAYER PHARMA AG 51368 LEVERKUSEN-BAYER PHARMA AG 51368 LEVERKUSENGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X14.0 TABLET BLISTER
399NDA/MAL/HDP/0750BAYER PHARMASURGIPHARM (U) LIMITEDXARELTO 20MGRIVAROXABAN20MGBAYER PHARMA AG 51368 LEVERKUSEN-BAYER PHARMA AG 51368 LEVERKUSENGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X14.0 TABLET BLISTER
400NDA/MAL/HDP/0751MICRO LABS LIMITEDLABOREX UGANDA LIMITEDDOLOWINACECLOFENAC100MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER
401NDA/MAL/HDP/0752FERRER INTERNACIONAL S.ALABOREX UGANDA LIMITEDNUCLEO C.M.P FORTECYTIDINE + URIDINE10MG + 6MGFERRER INTERNACIONAL S.A --GRAN VIA CARLOS III 94 08028 BARCELONASPAINPARENTERAL ORDINARY DRY PRE-FILLED PENS1.0X3.0 ML AMPOULE + 1 *2ML CLEAR GLASS AMPOULES FOR SOLVENT
402NDA/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 GERMANYGERMANYORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER
403NDA/MAL/HDP/0755TROIKAA PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDT- DOLTRAMADOL HYDROCHLORIDE50MG/MLTROIKAA PHARMACEUTICALS LTD- SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHANDINDIAPARENTERAL ORDINARY AMPOULES1.0X5.0X2.0 ML AMPOULE
404NDA/MAL/HDP/0756CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDTOLFREE 100TOLPERISONE100MGCADILA HEALTHCARE LTD-PLOT 203-213, KUNDAIM INDUSTRIAL ESTATE, GOAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER
405NDA/MAL/HDP/0757CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDTOLFREE 150TOLPERISONE150MGCADILA HEALTHCARE LTD-PLOT 203-213, KUNDAIM INDUSTRIAL ESTATE, GOAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER
406NDA/MAL/HDP/0759MICRO LABS LTDLABOREX UGANDA LIMITEDCOTRIMOXAZOLECOTRIMOXAZOLE960MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER
407NDA/MAL/HDP/0760STRIDESSUPER PHARMACEUTICALS LIMITEDCEFAXCEFTRIAXONE1GREYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100CHINAPARENTERAL ORDINARY DRY VIALS1.0X10.0X1.0 G VIAL
408NDA/MAL/HDP/0761BEIJING HOLLEY COTEC PHARMA CHINASUPER PHARMACEUTICALS LIMITEDBENZILINBENZATHINE BENZYLPENICILLIN 2.4MEGA/VIALREYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100CHINAPARENTERAL ORDINARY DRY VIALS1.0X50.0X2.4 MU VIAL
409NDA/MAL/HDP/0764UNICHEM LABORATORIES LTDEUROPA HEALTHCARE (U) LTDCORVADIL 5AMLODIPINE5MGUNICHEM LABORATORIES LIMITED UNIT II-VILLAGE BHATAULI KALAN BADDI DIST SOLAN HIMACHAL PRADESH 173 205INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET STRIP
410NDA/MAL/HDP/0765PHARM ACCESS AFRICA LTDUNITED HEALTHCARE DISTRIBUTORS LTDLEVOPLANTLEVONORGESTREL75MGSHANGHAI DAHUA PHARMACEUTICAL CO. LTD-CHANG ZENG FARM, CHONGMING COUNTY, SHANGHAICHINAPARENTERAL RETARD IMPLANTS1.0X10.0X2.0 ROD IMPLANT
411NDA/MAL/HDP/0768FDC LTDAIVEEN (U) LIMITEDPYRIMON EYE DROPDEXAMETHASONE/CHLORAMPHENICOL1%W/V + 0.1%W/VFDC LIMITED -B-8, M.I.D.C., INDUSTRIAL AREA, WALUJ – AURANGABAD- 431 136 MAHARASHTRA, INDIA. INDIAOPHTHALMIC DROPS1.0X5.0 ML BOTTLE
412NDA/MAL/HDP/0769BEIJING HOLLEY COTEC PHARMA CHINASUPER PHARMACEUTICALS LIMITEDAMPIL-1000AMPICILLIN1GREYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100CHINAPARENTERAL ORDINARY DRY VIALS1.0X50.0 VIAL CARTON
413NDA/MAL/HDP/0770BEIJING HOLLEY COTEC PHARMA CHINASUPER PHARMACEUTICALS LIMITEDAMPIL-500AMPICILLIN500MGREYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100CHINAPARENTERAL ORDINARY DRY VIALS1.0X50.0X500.0 MG VIAL
414NDA/MAL/HDP/0772MEGA LIFESCIENCES (AUSTRALIA) PTY LTDABACUS PHARMA (AFRICA) LIMITEDLIGABA - 150PREGABALIN150MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER
415NDA/MAL/HDP/0774CADILA PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.NODONNEBIVOLOL10MGCADILA HEALTH CARE LIMITED -PLOT 203-213, KUNDAIM INDUSTRIAL ESTATE, GOAINDIAORAL SOLID ORDINARY TABLETS1.0X3.0X1.0X10.0 TABLET BLISTER
416NDA/MAL/HDP/0775MEGA LIFESCIENCES (AUSTRALIA) PTY LTDABACUS PHARMA (AFRICA) LIMITEDLIGABA - 75PREGABALIN75MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER
417NDA/MAL/HDP/0776FREDUN PHARMACEUTICALS LTDPLANET PHARMACEUTICALS UGANDA LTDFREMOL TABLETSPARACETAMOL TABLETS500MGFREDUN PHARMACEUTICALS LTD-14,15,16 ZORBIAN INDUSTRIAL COMPLEX VEOOR PALGHAR EAST INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
418NDA/MAL/HDP/0780CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDATORVA TABLETSATORVASTATIN10MGCADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X5.0X1.0X7.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER
419NDA/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 BLISTER
420NDA/MAL/HDP/0792ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDAS-VPHENOXYMETHYL PENICILLIN250MGASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET STRIP
421NDA/MAL/HDP/0795AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOPEN-250PHENOXYMETHYL PENICILLIN POTASSIUM250MGMILAN LABORATORIES (INDIA) PVT LTD .-PLOTS 63,67,87,35,36,64,65, JAWAHAR CO-OP IND. ESTATE LTD, KAMOTHE, PANVEL (NAVI MUMBAI)INDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
422NDA/MAL/HDP/0796HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDAMLO-H 5AMLODIPINE BESILATE5MGHETERO LABS LTD. UNIT (V) .-S.N0.439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE), JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA.INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER
423NDA/MAL/HDP/0797NVS KENYA LTDSURGIPHARM (U) LIMITEDAFINITOR 5MGEVEROLIMUS5MGNORVATIS PHARMA STEIN AG-SCHAFF HAUSER STRASSE 4332, STEIN - SWITZERLANDSWITZERLANDORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET BLISTER
424NDA/MAL/HDP/0798HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDAMLO-H 10AMLODIPINE BESILATE10MGHETERO LABS LTD (UNIT-V)-SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER
425NDA/MAL/HDP/0799NVS KENYA LTDSURGIPHARM (U) LIMITEDAFINITOR 10MGEVEROLIMUS10MGNORVATIS PHARMA STEIN AG-SCHAFF HAUSER STRASSE 4332, STEIN - SWITZERLANDSWITZERLANDORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET BLISTER
426NDA/MAL/HDP/0802NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDEXFORGE HCT 5MG/ 160MG/12.5MGAMLODIPINE + VALSARTAN + HYDROCHLOROTHIAZIDE5MG+ 160MG+ 12.5MGNOVARTIS PHARMA STEIN AG-SCHAFFHARVSERTRASSE CH-4332 STEIN SWITZERLAND.,NOVARTIS FARMACEUTICA SA-RONDA DE SANTA MARIA,158, E-08210 BARBERA DEL VALLES BARCELONA SPAINSWITZERLANDORAL SOLID ORDINARY FILM-COATED TABLETS1.0X4.0X7.0 TABLET BLISTER
427NDA/MAL/HDP/0808PIRAMAL HEALTHCARE LTDTATA UGANDA LIMITEDISOFLURANEISOFLURANE250MLPIRAMAL ENTERPRISES LTD, INDIA-DIGWAL VILLAGE KOHIR MENDAL MEDAK DISTRICT,ANDHRA PRADESHINDIAOTHER SYSTEMIC LIQUID INHALATIONS1.0X250.0 ML BOTTLE,1.0X100.0 ML BOTTLE
428NDA/MAL/HDP/0811MICRO LABS LIMITEDLABOREX UGANDA LIMITEDDOLOWIN -SRACECLOFENAC200MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER
429NDA/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 BLISTER
430NDA/MAL/HDP/0820MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDFIXIME 400MGCEFIXIME400MGNKUNZI PHARMACEUTICALS-259 DAVIDSON ROAD, WADEVILLEGERMISTON, 1428 SOUTH AFRICASOUTH AFRICAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X5.0 TABLET BLISTER,1.0X1.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER
431NDA/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 BLISTER
432NDA/MAL/HDP/0822ABACUS PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDCLOXCIN-500CLOXACILLIN SODIUM500MGREYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100CHINAPARENTERAL ORDINARY DRY VIALS1.0X50.0X1.0 G VIAL
433NDA/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, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER
434NDA/MAL/HDP/0824I CARE PHARMA LIMITEDVITACARE LTDCLOXACILLINCLOXACILLIN250MGREYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER, 1.0X1000.0 CAPSULE CONTAINER
435NDA/MAL/HDP/0826I CARE PHARMA LIMITEDVITACARE LTDAMOXYCILLINAMOXYCILLIN250MGREYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER, 1.0X1000.0 CAPSULE CONTAINER
436NDA/MAL/HDP/0827GALPHA LABORATORIES LTDAIVEEN (U) LIMITEDCLANOXY 1.2AMOXICILLIN + CLAVULANATE1000 MG + 200 MGGALPHA LABORATORIES LTD-AT: ALKEM LABORATORIES LTD PLOT 167/2 MAHATMA UDYOG NAGAR AMALIYA DAMAN 396210INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0 ML VIAL 1*20ML VIAL OF WFI
437NDA/MAL/HDP/0830MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDEUTHYROX 25 MCGLEVOTHYROXINE SODIUM25 MCGMERCK KGAA - -FRANKFRUTER STRASSE 250, D-64293,DARMSTADT- GERMANYGERMANYORAL SOLID ORDINARY TABLETS1.0X1.0X30.0 TABLET BLISTER,1.0X4.0X25.0 TABLET BLISTER
438NDA/MAL/HDP/0831I CARE PHARMA LIMITEDVITACARE LTDAMPICILLIN CAPSULESAMPICILLIN250MGREYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100CHINAORAL SOLID ORDINARY OTHER CAPSULES1.0X10.0X10.0 CAPSULE BLISTER, 1.0X1000.0 CAPSULE CONTAINER
439NDA/MAL/HDP/0832MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDEUTHYROX 100MCGLEVOTHYROXINE100MCGMERCK KGAA - -FRANKFRUTER STRASSE 250, D-64293,DARMSTADT- GERMANYGERMANYORAL SOLID ORDINARY TABLETS1.0X4.0X25.0 TABLET BLISTER,1.0X1.0X30.0 TABLET BLISTER
440NDA/MAL/HDP/0834LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDVOMI-6DOXYLAMINE SUCCINATE & PYRIDOXINE HYDROCHLORIDE10MG + 10MGLINCOLN PHARMACEUTICALS LIMITED.-TRIMUL ESTATE NEAR KHATRAJ CHOKADI KHATRAJ 382721 GHANDHINAGAR GUJARATINDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X10.0X1.0X10.0 TABLET BLISTER
441NDA/MAL/HDP/0835AGOG PHARMA LTD.GITTOES PHARMACEUTICALS LIMITEDAGOBISBISACODYL5MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
442NDA/MAL/HDP/0836LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDCALBONE-500CALCIUM CARBONATE + COLECALCIFEROL1250MG + 250 I.ULINCOLN PHARMACEUTICALS LIMITED -10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER
443NDA/MAL/HDP/0841MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDETHOMIDETHIONAMIDE250MGMACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET STRIP
444NDA/MAL/HDP/0842LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDSACSECNIDAZOLE1000MGLINCOLN PHARMACEUTICALS LIMITED -10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X2.0 TABLET BLISTER
445NDA/MAL/HDP/0843MACLEODS PHARMACEUTICAL LTDNORVIK ENTERPRISES LIMITEDCOXERINCYCLOSERINE250MGMACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIAINDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE STRIP
446NDA/MAL/HDP/0845VIRBAC RSA (PTY) LTDMETRO PHARMACEUTICALS LIMITEDOLEVO-500LEVOFLOXACIN500 MGLINCOLN PHARMACEUTICALS LIMITED -10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X5.0X10.0 TABLET BLISTER
447NDA/MAL/HDP/0846MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDMOXIMACMOXIFLOXACIN400MGMACLEODS PHARMACEUTICALS LTD--PLOT 25-27 SURVEY NO. 366 PREMIER INDUSTRIAL ESTATE KACHIGAM DAMANINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X5.0 TABLET BLISTER
448NDA/MAL/HDP/0848MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDMACROZIDE 500PYRAZINAMIDE500MGMACLEODS PHARMACEUTICALS LTD---PLOT NO 25-27 SURVEY PREMEIRE INDUSTRIAL ESTATE KACHIGAM DAMAN (U.T) 396401INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CONTAINER
449NDA/MAL/HDP/0850LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDLCT KITLANSOPRAZOLE + CLARITHROMYCIN + TINIDAZOLE30MG + 250MG + 500MGLINCOLN PHARMACEUTICALS LIMITED -10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X7.0X1.0X6.0 TABLET BLISTER (BLISTER CONTAINS 2 CAPSULES AND 4 TABLETS)
450NDA/MAL/HDP/0852MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDKAPOCIN-1GCAPREOMYCIN1000MGMACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIAINDIAPARENTERAL ORDINARY DRY VIALS1.0X50.0 VIAL CARTON
451NDA/MAL/HDP/0854GLENMARK PHARMACUTICALS LTDSTAR PHARMACEUTICALS LTDIBICAR-50BECLOMETASONE50MCG PER ACTUATIONGLENMARK PHARMACEUTICALS LTD (UNIT III).-UNIT III VILLAGE KISHANPURA,BADDI-NALAGARH ROAD TEHSIL BADDI,DISTT. SOLAN, HIMACHAL PRADESH -173 205 INDIA
INDIALUNG ADMINISTRATION METERED-DOSE INHALER1.0X200.0 METERED DOSE CANNISTER
452NDA/MAL/HDP/0855HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDLAZINELEVOCETIRIZINE DIHYDROCHLORIDE5MGHETERO LABS LTD-22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESHINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER
453NDA/MAL/HDP/0856MACLEODS PHARMACEUTICAL LTDNORVIK ENTERPRISES LIMITEDKANAMAC-1000KANAMYCIN1GMACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIAINDIAPARENTERAL ORDINARY DRY VIALS1.0X50.0X1000.0 MG VIAL
454NDA/MAL/HDP/0857GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDCANDID-V6 VAGINAL TABLETSCLOTRIMAZOLE100MGGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,DINDIAVAGINAL TABLETS1.0X6.0 PESSARY STRIP
455NDA/MAL/HDP/0858ASTRAZENECAMACNAUGHTON LIMITEDPLENDILFELODIPINE5MGASTRAZENECA AB,-GARTUNA & SNACKVIKEN STOCKHOLMSWEDENORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET CONTAINER
456NDA/MAL/HDP/0860MSN LABORATORIES LTDPLANET PHARMACEUTICALS UGANDA LTDFLOXSAFE 400MOXIFLOXACIN HYDROCHLORIDE400MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X5.0 TABLET BLISTER
457NDA/MAL/HDP/0861SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDPROZINEPROMETHAZINE25MG/MLSAKAR HEALTHCARE PVT. LTD-PLOT 10/13 SAKHEJ-BAVLA ROAD, AHMEDABAD,GUJURAT,INDIAINDIAPARENTERAL ORDINARY AMPOULES2.0X5.0X2.0 ML AMPOULE
458NDA/MAL/HDP/0862GLENMARK PHARMACUTICALS LTDSTAR PHARMACEUTICALS LTDIBICAR- 200BECLOMETASONE200MCG PER ACTUATIONGLENMARK PHARMACEUTICALS LTD (UNIT III).-UNIT III VILLAGE KISHANPURA,BADDI-NALAGARH ROAD TEHSIL BADDI,DISTT. SOLAN, HIMACHAL PRADESH -173 205 INDIA
INDIALUNG ADMINISTRATION METERED-DOSE INHALER1.0X200.0 METERED DOSE CANNISTER
459NDA/MAL/HDP/0864HETERO LABS LTD UNIT IXABACUS PHARMA (AFRICA) LIMITEDPANTIN-40PANTOPRAZOLE SODIUM40 MGHETERO LABS LIMITED UNIT V-APIIC PHARMA SEZ, S. NO. 439, 440, 441 & 458 POLEPALLY VILLAGE, JADCHERLA MANDAL, MAHABOOBNAGAR (DISTRICT). PIN 509301INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER
460NDA/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, GUJARATINDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X300.0 ML BOTTLE,1.0X100.0 ML BOTTLE
461NDA/MAL/HDP/0867HETERO LABS LTD UNIT IXABACUS PHARMA (AFRICA) LIMITEDPANTIN-20PANTOPRAZOLE SODIUM20MGHETERO LABS LIMITED UNIT V-APIIC PHARMA SEZ, S. NO. 439, 440, 441 & 458 POLEPALLY VILLAGE, JADCHERLA MANDAL, MAHABOOBNAGAR (DISTRICT). PIN 509301INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER
462NDA/MAL/HDP/0868SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDVARMIKA-500AMIKACIN500MGSAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIAINDIAPARENTERAL ORDINARY AMPOULES1.0X2.0X5.0X2.0 ML AMPOULE
463NDA/MAL/HDP/0869SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDLARTRMARTEMETHER80MG/MLSAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIAINDIAPARENTERAL ORDINARY I M AMPOULES1.0X6.0X1.0 ML AMPOULE
464NDA/MAL/HDP/0870TROIKAA PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDTROY-KPHYTOMENADIONE10MG/MLTROIKAA PHARMACEUTICALS LIMITED-THOL, DIST. MEHSANA-382728, GUJARAT,INDIAINDIAPARENTERAL ORDINARY AMPOULES1.0X10.0X1.0 ML AMPOULE
465NDA/MAL/HDP/0871SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDDEXADEXAMETHASONE SODIUM4MG/MLSAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIAINDIAPARENTERAL ORDINARY DRY VIALS2.0X6.0X2.0 ML VIAL
466NDA/MAL/HDP/0873GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDOXYTOCIN INJECTIONOXYTOCIN10I.U/MLNINGBO DAHONGYING PHARMACEUTICAL CO LTD-NO 396, MINGZHU ROAD NINGBO CITY CHINACHINAPARENTERAL ORDINARY AMPOULES1.0X10.0X1.0 ML AMPOULE
467NDA/MAL/HDP/0874LEBEN LABORATORIES PVT LTDANDYCO PHARMACY (UGANDA) LTDLEBASMA-4SALBUTAMOL4MGLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL SOLID ORDINARY TABLETS1.0X20.0X10.0 TABLET BLISTER
468NDA/MAL/HDP/0877LEBEN LABORATORIES LTDANDYCO PHARMACY (UGANDA) LTDANTAGIT DS GEL MINT FLAVOURDRIED ALUMINIUM HYDROXIDE + MAGNESIUM HYDROXIDE + SIMETHICONE400MG + 400MG + 50MGLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X1.0X170.0 ML BOTTLE
469NDA/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 BLISTER
470NDA/MAL/HDP/0882MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDGLUCOVANCE 500MG/2.5MGMETFORMIN + GLIBENCLAMIDE500MG + 2.5MGMERCK SANTE S.A.S-CENTRE DE PRODUCTION DE SEMOY 2 RUE DU PRESSIOR VERT 45400 SEMOYFRANCEORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X15.0 TABLET BLISTER,1.0X4.0X15.0 TABLET BLISTER
471NDA/MAL/HDP/0883MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDGLUCOVANCE 500MG/5MGMETFORMIN + GLIBENCLAMIDE500MG + 5MGMERCK SANTE S.A.S-CENTRE DE PRODUCTION DE SEMOY 2 RUE DU PRESSIOR VERT 45400 SEMOYFRANCEORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X15.0 TABLET BLISTER,1.0X4.0X15.0 TABLET BLISTER
472NDA/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 BOTTLE
473NDA/MAL/HDP/0894HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDGIAGRA 100SILDENAFIL CITRATE100MGHETERO LABS LTD. UNIT (V)-439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE),
JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA.
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X4.0X10.0 TABLET BLISTER
474NDA/MAL/HDP/0895VIRCHOW HEALTHCARE PVT LTDSURGIPHARM (U) LIMITEDHYORTHSODIUM HYALURONATE10MG/1MLVIRCHOW BIOTECH PVT, LTD-SURVEY NO. 172, PART GAGILLAPUR, QUTHBULLAPUR, R.R, DISTINDIAPARENTERAL ORDINARY PRE-FILLED SYRINGES1.0X2.0 ML PRE- FILLED SYRINGE
475NDA/MAL/HDP/0897VIRCHOW HEALTHCARE PVT LTDSURGIPHARM (U) LIMITEDDEBRIDACEPAPAIN + UREA521700UNITS+100MG/GVIRCHOW BIOTECH PVT, -SURVEY NO. 172, PART GAGILLAPUR, QUTHBULLAPUR, R.R, DISTRICT TELANGANAINDIATOPICAL EXTERNAL OINTMENTS1.0X15.0 G TUBE
476NDA/MAL/HDP/0898HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDLOSAGEN 50LOSARTAN POTASSIUM50MGHETERO LABS LTD (UNIT-V)-SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER
477NDA/MAL/HDP/0899VIRCHOW HEALTHCARE PVT LTDSURGIPHARM (U) LIMITEDVIRIAXONECEFTRIAXONE1GINJECTCARE PARENTERALS PVT. LTD.-PLOT130 SILVASSA ROAD GIDC VAPI 396195 GUJARATINDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0 G VIAL + 10 ML VIAL WFI
478NDA/MAL/HDP/0900ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDLAPSONEDAPSONE100MGASTRA LIFECARE (INDIA) PVT. LTD-PLOT 57/P, SARKHEJ-BAVLA HIGHWAY, RAJODA 382 220, AHMEDABAD, INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
479NDA/MAL/HDP/0902AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOPINE SRNIFEDIPINE20MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID RETARD FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER
480NDA/MAL/HDP/0903GLAXO WELLCOME(KENYA) LTDERIS LTDZANTACRANITIDINE50MG/2MLGLAXO SMITHKLINE MANUFACTURING S.P.A .-STARDA PROVINCIALE ASOLANA 90, 43056 SAN POLO DI TORRILE (PARMA)ITALYPARENTERAL ORDINARY AMPOULES1.0X2.0 ML AMPOULE
481NDA/MAL/HDP/0905NECTAR LIFESCIENCES LTDAIVEEN (U) LIMITEDNECPODCEFPODOXIME PROXETIL200MGNECTAR LIFESCIENCES LTD UNIT VI-BHATOLIKALAN P.O BAROTIWALA DISTT SOLAN HIMACHAL PRADESH 173205INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET STRIP
482NDA/MAL/HDP/0906VIRCHOW HEALTHCARE PVT LTDSURGIPHARM (U) LIMITEDIONSILSILVER NITRATE0.2%W/WVIRCHOW BIOTECH PVT, -SURVEY NO. 172, PART GAGILLAPUR, QUTHBULLAPUR, R.R, DISTRICT TELANGANAINDIATOPICAL EXTERNAL GELS AND SOLS1.0X15.0 G TUBE
483NDA/MAL/HDP/0907NECTAR LIFESCIENCES LTDAIVEEN (U) LIMITEDCEFUAXITCEFUROXIME AXETIL250MGNECTAR LIFE SCIENCES LTD--UNIT VI BHATOLIKALAN DIST SOLAN H.PINDIAORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET STRIP
484NDA/MAL/HDP/0908VIRCHOW HEALTHCARE PVT LTDSURGIPHARM (U) LIMITEDHYOPT PLUSSODIUM HYALURONATE11.9MG/0.85MLVIRCHOW BIOTECH PVT, -SURVEY NO. 172, PART GAGILLAPUR, QUTHBULLAPUR, R.R, DISTRICT TELANGANAINDIAPARENTERAL ORDINARY PRE-FILLED SYRINGES1.0X0.85 ML PRE- FILLED SYRINGE
485NDA/MAL/HDP/0909NECTAR LIFESCIENCES LTDAIVEEN (U) LIMITEDFIXINECTCEFIXIME100MGNECTAR LIFESCIENCES LTD UNIT VI-BHATOLIKALAN P.O BAROTIWALA DISTT SOLAN HIMACHAL PRADESH 173205INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET STRIP
486NDA/MAL/HDP/0911VIRCHOW HEALTHCARE PVT LTDSURGIPHARM (U) LIMITEDHEALACERECOMBINANT HUMAN PLATELET DERIVED GROWTH FACTOR -B100MCG/GVIRCHOW BIOTECH PVT, LTD-SURVEY NO. 172, PART GAGILLAPUR, QUTHBULLAPUR, R.R, DISTINDIATOPICAL EXTERNAL GELS AND SOLS1.0X15.0 G TUBE
487NDA/MAL/HDP/0914VIRCHOW HEALTHCARE PVT LTDSURGIPHARM (U) LIMITEDOSTEOTIDETERIPARATIDE [RECOMBINANT HUMAN PARATHYROID HORMONE (1-34)] INJECTION250MCG/MLVIRCHOW BIOTECH PVT LTD -SURVEY NO. 172, PART GAGILLAPUR, QUTHBULLAPUR, R.R, DISTRICT ANDHRA PRADESHINDIAORAL LIQUID ORDINARY LIQUIDS1.0X3.0 ML VIAL
488NDA/MAL/HDP/0915NOVARTIS PHARMA SERVICES INCSURGIPHARM (U) LIMITEDCURAMAMOXICILLIN + CLAVULANIC ACID875 MG + 125 MGSANDOZ GMBH-BIOCHEMIESTRASSE 10, A6250 KUNDL, TYROL, AUSTRIA AUSTRIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X7.0X2.0 TABLET STRIP
489NDA/MAL/HDP/0920TROIKAA PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDBUPITROY HEAVYBUPIVACAINE HYDROCHLORIDE5MG/ML TROIKAA PHARMACEUTICALS LTD .-SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHAND, INDIAINDIAPARENTERAL ORDINARY VIALS1.0X5.0X4.0 ML VIAL
490NDA/MAL/HDP/0926MICRO LABS LIMITEDLABOREX UGANDA LIMITEDBACTOCLAV-375AMOXICILLIN +CLAVULANATE POTASSIUM250MG + 125MGMICRO LABS LIMITED.-PLOT 16, VEERASANDRA IND. AREA,ANEKAL TALUK, BANGALORE INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X6.0 TABLET STRIP,1.0X2.0X10.0 TABLET STRIP
491NDA/MAL/HDP/0928AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDINSTACLOP 75CLOPIDOGREL75MGAJANTA PHARMA LTD--B-4/5/6 MIDC INDUSTRIAL AREA PAITHAN 431 128 AURANGABADINDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET STRIP
492NDA/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 BLISTER
493NDA/MAL/HDP/0931LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDARH JUNIORALPHA-BETA ARTEETHER75MG/MLSAKAR HEALTHCARE PVT. LTD-PLOT 10/13 SAKHEJ-BAVLA ROAD, AHMEDABAD,GUJURAT,INDIAINDIAPARENTERAL ORDINARY AMPOULES1.0X3.0X1.0 ML AMPOULE
494NDA/MAL/HDP/0934CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDODIMONT 4MONTELUKAST4MGB. BRAUN MELSUNGEN - MISTELWEG-1389, TRABAD ROAD, DHOLKA 387 810, DISTRICT AHMEDABAD, GUJARAT, INDIAINDIAORAL SOLID ORDINARY CHEWABLE COATED TABLETS1.0X3.0X10.0 TABLET BLISTER
495NDA/MAL/HDP/0937CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDVALAZYD H 92.5VALSARTAN/HYDROCHLOROTHIAZIDE80MG/12.5MGCADILA HEALTH CARE LIMITED-KUNDAIM INDUSTRIAL ESTATE, PONDA, GOA-403401, INDIA.
.
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER
496NDA/MAL/HDP/0939LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDARHALPHA -BETA ARTEETHER150MG /2MLSAKAR HEALTHCARE PVT. LTD-PLOT 10/13 SAKHEJ-BAVLA ROAD, AHMEDABAD,GUJURAT,INDIAINDIAPARENTERAL ORDINARY AMPOULES1.0X3.0X2.0 ML AMPOULE
497NDA/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 BOTTLE
498NDA/MAL/HDP/0942LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDARH FORTEALPHA -BETA ARTEETHER225MG/ 3MLSAKAR HEALTHCARE PVT. LTD-PLOT 10/13 SAKHEJ-BAVLA ROAD, AHMEDABAD,GUJURAT,INDIAINDIAPARENTERAL ORDINARY AMPOULES1.0X3.0X3.0 ML AMPOULE
499NDA/MAL/HDP/0943MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDSTREPTOMYCIN INJECTION BPSTREPTOMYCIN1GMACLEODS PHARMACEUTICALS LTD--PLOT 25-27 SURVEY NO. 366 PREMIER INDUSTRIAL ESTATE KACHIGAM DAMANINDIAPARENTERAL ORDINARY DRY VIALS1.0X100.0X1.0 G VIAL
500NDA/MAL/HDP/0945CLARIS LIFE SCIENCES LIMITEDREDDYS PHARMA LIMITEDZOFEXOFLOXACIN2 MG/MLCLARIS OTSUKA LIMITED-VILLAGE – VASANA – CHACHARWADIP,
TAL: SANAND, AHMADABAD
INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X100.0 ML BOTTLE
501NDA/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 BLISTER
502NDA/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 AREAKENYAORAL LIQUID ORDINARY LIQUIDS1.0X60.0 ML BOTTLE
503NDA/MAL/HDP/0951NEON LABARATORIES LTDAIVEEN (U) LIMITEDNORADSTERILE NORADRENALINE CONCENTRATE2MG/2MLNEON LABORATORIES LTD-PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROADINDIAPARENTERAL ORDINARY S C AMPOULES1.0X5.0X2.0 ML AMPOULE
504NDA/MAL/HDP/0952NEON LABARATORIES LTDAIVEEN (U) LIMITEDEFECATALCEFTRIAXONE1GNEON LABORATORIES LTD-PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROADINDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0 G VIAL
505NDA/MAL/HDP/0953NEON LABARATORIES LTDAIVEEN (U) LIMITEDCIZCANCISPLATIN10MG/10MLNEON LABORATORIES LTD-PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROADINDIAPARENTERAL ORDINARY VIALS1.0X10.0 ML VIAL
506NDA/MAL/HDP/0954NEON LABARATORIES LTDAIVEEN (U) LIMITEDANAWINBUPIVACAINE50MG/20MLNEON LABORATORIES LTD-PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROADINDIAPARENTERAL RETARD OTHER VIALS1.0X20.0 ML VIAL
507NDA/MAL/HDP/0955I CARE PHARMA LIMITEDVITACARE LTDINDOXINDOMETHACIN USP25MGWUHAN GRAND PHARMACEUTICAL GROUP.CO.LTD-NO.5 GUTIAN ROAD WUHAN HUBEL PR OF CHINACHINAORAL SOLID ORDINARY CAPSULES1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER
508NDA/MAL/HDP/0956I CARE PHARMA LIMITEDVITACARE LTDGENTAMICIN INJECTION BPGENTAMICIN80MG/2MLGRAND PHARMACEUTICAL(CHINA) CO.LTD-NO.5 GUTIAN ROAD QIAOKOU DISTRICT WUHAN CITY HUBEI PROVINCECHINAPARENTERAL ORDINARY AMPOULES1.0X10.0X2.0 ML AMPOULE
509NDA/MAL/HDP/0957MACK BROWN PHARMACEUTICALS PVT LIMITEDSHURIK LTDLYRED SYRUPVITAMINE A + VITAMINE E ACETATE + ASCORBIC ACID + SELENIUM + ZINC2500 IU + 10 IU + 50MG + 35MCG + 3MGTORQUE PHARMACEUTICALS PVT LTD-ISAAPUR P.O DAPPAR 140056 INDIAINDIAORAL LIQUID ORDINARY SYRUPS1.0X200.0 ML BOTTLE
510NDA/MAL/HDP/0958I CARE PHARMA LIMITEDVITACARE LTDFUROSEMIDEFUROSEMIDE10MG/2MLGRAND PHARMACEUTICAL(CHINA) CO.LTD-NO.5 GUTIAN ROAD QIAOKOU DISTRICT WUHAN CITY HUBEI PROVINCECHINAPARENTERAL ORDINARY AMPOULES1.0X10.0X2.0 ML AMPOULE
511NDA/MAL/HDP/0960I CARE PHARMA LIMITEDVITACARE LTDVITAMIN B COMPLEX INJECTIONVITAMIN B1+VITAMIN B6+ VITAMIN B2+VITAMIN B5+ NICOTINAMIDE20MG+2MG+27.4MG+1MG+30MGWUHAN GRAND PHARMACEUTICALS GROUP CO.LTD-M/S NO. 5 GUTIAN RD, WUHAN, HUBEI CHINACHINAPARENTERAL ORDINARY AMPOULES1.0X10.0X2.0 ML AMPOULE
512NDA/MAL/HDP/0962I CARE PHARMA LIMITEDVITACARE LTDFORTIFIED PROCAINE BENZYL PENICILLINFORTIFIED PROCAINE BENZYL PENICILLIN4 MUREYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100CHINAPARENTERAL ORDINARY I M VIALS1.0X4.0 MU VIAL
513NDA/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 BLISTER
514NDA/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 BLISTER
515NDA/MAL/HDP/0967I CARE PHARMA LIMITEDVITACARE LTDSTREPTOMYCINSTREPTOMYCIN1GREYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100CHINAPARENTERAL ORDINARY VIALS1.0X10.0 VIAL CARTON
516NDA/MAL/HDP/0969EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDASOMEX-2.5AMLODIPINE BESILATE2.5MGEMCURE PHARMACEUTICALS LTD -LANE NO.3 PHASE II,SIDCO INDUSTRIAL COMPLEX,BARI-BRAHMANA JAMMU 181 133, INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X5.0X10.0 TABLET BLISTER
517NDA/MAL/HDP/0971I CARE PHARMA LIMITEDVITACARE LTDBENZYLPENICILLIN INJECTIONBENZYL PENICILLIN SODIUM1MUREYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100CHINAPARENTERAL ORDINARY I M VIALS1.0X10.0 VIAL CARTON,1.0X50.0 VIAL CARTON
518NDA/MAL/HDP/0972PHARCO PHARMACEUTICALS COMPANY LTDECHO PHARMACY (U) LIMITEDAZOMYCINAZITHROMYCIN DIHYDRATE200 MG/5MLPHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT.
P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT
EGYPTORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X15.0 ML BOTTLE
519NDA/MAL/HDP/0975PHARCO PHARMACEUTICALSECHO PHARMACY (U) LIMITEDCETRAK SYRUPCETIRIZINE DIHYDROCHLORIDE5MG/5MLPHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT.
P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT
EGYPTORAL LIQUID ORDINARY SYRUPS1.0X120.0 ML BOTTLE
520NDA/MAL/HDP/0977PHARCO PHARMACEUTICALSECHO PHARMACY (U) LIMITEDCETRAKCETIRIZINE DIHYDROCHLORIDE10MGPHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT.
P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT
EGYPTORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER
521NDA/MAL/HDP/0980PHARCO PHARMACEUTICALSECHO PHARMACY (U) LIMITEDAZOMYCINAZITHROMYCIN250MGPHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT.
P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT
EGYPTORAL SOLID ORDINARY CAPSULES1.0X1.0X6.0 CAPSULE BLISTER
522NDA/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 CONTAINER
523NDA/MAL/HDP/0984CADILA PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.JOVAN T20TADALAFIL20MGCADILA PHARMACEUTICALS LIMITED-1389 DHOLKA 387810 DISTRCT AHMEDABAD GUJARAT STATEINDIAORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER
524NDA/MAL/HDP/0986EVA PHARMAWIDE SPECTRUM ENTERPRISES (U) LIMITEDCONVENTINGABAPENTIN100MGEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPTEGYPTORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER
525NDA/MAL/HDP/0988CADILA PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.CADITOR 20ATORVASTATIN20MGCADILA PHARMACEUTICALS LIMITED-1389 DHOLKA 387810 DISTRCT AHMEDABAD GUJARAT STATEINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER
526NDA/MAL/HDP/0990EVA PHARMAWIDE SPECTRUM ENTERPRISES (U) LIMITEDFUSIDERM CREAMFUSIDIC ACID2%W/WEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPTEGYPTTOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE
527NDA/MAL/HDP/0995LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDFLUCOMOLPARACETAMOL + PHENYLEPHRINE HCL + DEXTROMETHORPHAN HBR + CHLORPHENIRAMINE MALEATE250MG + 5MG + 10MG + 2MGLINCOLN PHARMACEUTICALS LTD--TRIMUL ESTATE AFER VODSAR VILLAGE KHATJAT 382 721 GUJARAT VADSAR P.O.J TALUKA KALOH DIST GANDHINAGAR INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE
528NDA/MAL/HDP/0997EVA PHARMAWIDE SPECTRUM ENTERPRISES (U) LIMITEDGENUPHILGLUCOSAMINE SULPHATE SODIUM CHLORIDE+METHYLSULPHONYLMETHANE+CHONDROITIN SULPHATE375MG+375MG+300MGEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPTEGYPTORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER
529NDA/MAL/HDP/0998ROYAL GROUPHARLEYS UGANDA LIMITEDQUININE DIHYDROCHLORIDE INJECTIONQUININE DIHYDROCHLORIDE600MG/2MLGRAND PHARMACEUTICAL (CHINA) CO. LTD--LAKE ROAD NELL JINYINHU ECOLOGICAL PARKDONG XI HU DISTRICT, WUHAN, HEBEI PROVINCE.CHINAPARENTERAL ORDINARY AMPOULES1.0X10.0X2.0 ML AMPOULE
530NDA/MAL/HDP/0999EVA PHARMAWIDE SPECTRUM ENTERPRISES (U) LIMITEDTHIOEVATHIOTIC ACID600MGEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPTEGYPTORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X10.0 TABLET BLISTER
531NDA/MAL/HDP/1000TROIKAA PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDTROYCURIUMATRACURIUM10MG/MLTROIKAA PHARMACEUTICALS LIMITED-THOL, DIST. MEHSANA-382728, GUJARAT,INDIAINDIAPARENTERAL ORDINARY AMPOULES1.0X5.0X3.0 ML AMPOULE,1.0X5.0X2.5 ML AMPOULE
532NDA/MAL/HDP/1001EVA PHARMAWIDE SPECTRUM ENTERPRISES (U) LIMITEDTHIOTACID ACIDTHIOTIC ACID300MGEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPTEGYPTORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER
533NDA/MAL/HDP/1003EVA PHARMAWIDE SPECTRUM ENTERPRISES (U) LIMITEDZEFICAMLORNOXICAM8MGEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPTEGYPTORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X10.0 TABLET BLISTER
534NDA/MAL/HDP/1006MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDTRIPRIDE-2GLIMEPIRIDE + PIOGLITAZONE+ METFORMIN2MG+15MG+500MGMICRO LABS LTD 92 SIPCOT -92 SIPCOT HOSUR 635 126 TAMIL NADUINDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER
535NDA/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 BLISTER
536NDA/MAL/HDP/1009TROIKAA PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDBUPITROY 0.5%BUPIVACAINE5MG/ML TROIKAA PHARMACEUTICALS LTD .-SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHAND, INDIAINDIAPARENTERAL ORDINARY VIALS1.0X20.0 ML VIAL
537NDA/MAL/HDP/1010ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDASDOPA TABLETSMETHYLDOPA250MGASTRA LIFECARE (INDIA) PVT. LTD-PLOT 57/P, SARKHEJ-BAVLA HIGHWAY, RAJODA 382 220, AHMEDABAD, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER
538NDA/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 BOTTLE
539NDA/MAL/HDP/1013NEON LABARATORIES LTDAIVEEN (U) LIMITEDTHIOSOLTHIOPENTAL SODIUM500MGNEON LABORATORIES LTD-PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROADINDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0X20.0 ML VIAL
540NDA/MAL/HDP/1014ELYS CHEMICAL INDUSTRIES LTDVELVET PHARMA LIMITEDTIDAZOL TABLETSTINIDAZOLE500MGELYS CHEMICAL INDUSTRIES LIMITED-ROAD B’, OFF ENTERPRISE ROAD
PLOT NO. 209/8927 INDUSTRIAL AREA
KENYAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X20.0X4.0 TABLET BLISTER
541NDA/MAL/HDP/1015DAWA LIMITEDSUPER MEDIC LTDORACEFCEFALEXIN250MGDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER
542NDA/MAL/HDP/1016ELYS CHEMICAL INDUSTRIES LTDVELVET PHARMA LIMITEDASCORBIC ACIDASCORBIC ACID200MGELYS CHEMICAL INDUSTRIES LIMITED-ROAD B’, OFF ENTERPRISE ROAD
PLOT NO. 209/8927 INDUSTRIAL AREA
KENYAORAL SOLID ORDINARY TABLETS1.0X100.0X10.0 TABLET BLISTER
543NDA/MAL/HDP/1017ELYS CHEMICAL INDUSTRIES LTDVELVET PHARMA LIMITEDELYCLOXAMPICILLIN/CLOXACILLIN125MG/125MGELYS CHEMICAL INDUSTRIES LIMITED-ROAD B’, OFF ENTERPRISE ROAD
PLOT NO. 209/8927 INDUSTRIAL AREA
KENYAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE
544NDA/MAL/HDP/1018KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAM CHLORCHLORAMPHENICOL250MGKAMPALA PHARMECEUTICALS INDUSTRIES LTD.-PLOT M444B STRETCHER RD, NTINDA KLA UGANDAUGANDAORAL SOLID ORDINARY CAPSULES100.0 CAPSULE CONTAINER,1000.0 CAPSULE CONTAINER,250.0 CAPSULE CONTAINER,500.0 CAPSULE CONTAINER,1.0X10.0 CAPSULE CONTAINER
545NDA/MAL/HDP/1020LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDPA-12PARACETAMOL SUSTAINED RELEASE1000MGLINCOLN PHARMACEUTICALS LIMITED-10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
INDIAORAL SOLID RETARD LAYERED TABLETS1.0X10.0X1.0X12.0 TABLET BLISTER
546NDA/MAL/HDP/1021PT NOVELL PHARMACEUTICAL LABORATORIESECHO PHARMACY (U) LIMITEDCLINDAMYCINCLINDAMYCIN150MGPT NOVELL PHARMACEUTICAL LABORATORIES -J1 WANAHERANG NO. 35, TLAJUNG UDIK, GUNUNG
PUTRI, BORGO 16962
INDONESIA
INDONESIAORAL SOLID ORDINARY CAPSULES1.0X5.0X10.0 CAPSULE BLISTER
547NDA/MAL/HDP/1022EVA PHARMAWIDE SPECTRUM ENTERPRISES (U) LIMITEDCONVENTINGABAPENTIN300MGEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPTEGYPTORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER
548NDA/MAL/HDP/1023MYLAN LABORATORIES LIMITED.NORVIK ENTERPRISES LIMITEDZINNIA PLEVONORGESTREL + ETHINYLESTRADIOL 150MCG + 30MCGMYLAN LABORATORIES LIMITED.--PLOT NO. 1606-1609, SARIGAM INDUSTRIAL AREA, GIDC, SARIGAM, TAL-UMERGAM, DIST VALSAD, 396155, GUJARAT, INDIA.,MYLAN LABORATORIES LIMITED..-PLOT NO.20 & 21, PHARMEZ, SARKHEJ-BAVLA NATIONAL HIGHWAY NO. 08A, NEAR VILLAGE MATODA, TAL-SANAND, AHMEDABAD, GUJARAT, INDIA 382213INDIAORAL SOLID ORDINARY TABLETS1.0X28.0 TABLET BLISTER
549NDA/MAL/HDP/1025SANOFI –AVENTIS DEUTSCHLANDLABOREX UGANDA LIMITEDINSUMAN COMB 30INSULIN HUMAN100IU/MLSANOFI-AVENTIS DEUTSCHLAND GMBH -INDUSTRIEPARK HOECHST, BRUNINGSTRASSEN, BUILDING
H650 65926 FRANKFURT AM MAIN, GERMANY
GERMANYPARENTERAL ORDINARY S C VIALS1.0X10.0 ML VIAL,1.0X3.0 ML PRE- FILLED SYRINGE
550NDA/MAL/HDP/1031EVA PHARMAWIDE SPECTRUM ENTERPRISES (U) LIMITEDMOXIFLOXMOXIFLOXACIN400MGEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPTEGYPTORAL SOLID ORDINARY TABLETS1.0X1.0X5.0 TABLET BLISTER
551NDA/MAL/HDP/1032EVA PHARMAWIDE SPECTRUM ENTERPRISES (U) LIMITEDARTHFREE 20LEFLUNOMIDE20MGEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPTEGYPTORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER
552NDA/MAL/HDP/1033FAES FARMA S.ALABOREX UGANDA LIMITEDDYNAMOGENGLUTODINE (CYPROHEPTADINE ALPHA- KETOGLUTARATE) + ARGININE ASPARTATE3MG +1GFAES FARMA, S.A -MAXIMO AGUIRRE, 14, LEJONA 48940 VIZCAYASPAINORAL LIQUID ORDINARY LIQUIDS1.0X20.0X10.0 ML SACHET
553NDA/MAL/HDP/1034VOGEN LABORATORIES LTDBUFFALO HEALTH CARE LTDDURAMOXAMOXICILLIN250MG/5MLVOGEN LABORATORIES LTD-70, M.HERACLEOUS STR. AYIOS ATHANASIOS INDUSTRIAL AREA, LIMASSOL, CYPRUSCYPRUSORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE
554NDA/MAL/HDP/1035GUILIN PHARMACEUTICAL CO.LTDSTAR PHARMACEUTICALS LTDG-CIPROXCIPROFLOXACIN500MGGUILIN PHARMACEUTICAL CO.LTD.-NO.43 QUILIDIAN ROAD GUILIN 541002, GUANGXI, CHINACHINAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER
555NDA/MAL/HDP/1041SERUM INSTITUTE OF INDIA LTD.NORVIK ENTERPRISES LIMITEDREPOITINRECOMBINANT HUMAN ERYTHROPOIETIN4000 I.U/1MLSERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIAINDIAPARENTERAL ORDINARY PRE-FILLED SYRINGES1.0X1.0X1.0 ML PRE- FILLED SYRINGE,1.0X1.0X1.0 ML VIAL
556NDA/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 STRIP
557NDA/MAL/HDP/1049AGOG PHARMA LTD.GITTOES PHARMACEUTICALS LIMITEDAGOVATEBETAMETHASONE VALERATE0.1%W/WAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIATOPICAL EXTERNAL OINTMENTS1.0X15.0 G TUBE
558NDA/MAL/HDP/1050INTAS PHARMACEUTICALS LIMITEDNORVIK ENTERPRISES LIMITEDAMTAS-10AMLODIPINE10MGINTAS PHARMACEUTICALS LTD-PLOT 457/458, SARKHEJ BAVLA HIGHWAY
MATODA 382 210 TAL: SANAND, AHMEDABAD, INDIA
INDIAORAL SOLID ORDINARY TABLETS1.0X2.0X14.0 TABLET BLISTER,10.0X10.0 TABLET BLISTER
559NDA/MAL/HDP/1052AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDMICLOGENMICONAZOLE NITRATE+NEOMYCIN SULPHATE+CLOBETASOL PROPIONATE2.0%W/W+0.5%W/W+0.05%W/WAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE
560NDA/MAL/HDP/1054AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAZ-250AZITHROMYCIN250MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY CAPSULES1.0X1.0X6.0 CAPSULE BLISTER
561NDA/MAL/HDP/1056AGOG PHARMA LTD.GITTOES 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 TUBE
562NDA/MAL/HDP/1061NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDBISALAXBISACODYL5MGNEM LABORATORIES PVT LTD-133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAIINDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
563NDA/MAL/HDP/1062VENUS REMEDIES LTDHARLEYS UGANDA LIMITEDVANCONEX-CPVANCOMYCIN500MGVENUS REMEDIES LIMITED-UNIT II HILL TOP INDUSTRIAL ESTATE JHARMAJRI EPIP
PHASE I BHATOLI BADDI (HP) 173205
INDIA
INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0 VIAL CARTON
564NDA/MAL/HDP/1063EVA PHARMAWIDE SPECTRUM ENTERPRISES (U) LIMITEDVIRECTASILDENAFIL CITRATE100MGEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPTINDIAORAL SOLID ORDINARY TABLETS1.0X2.0X3.0 TABLET BLISTER
565NDA/MAL/HDP/1064VENUS REMEDIES LTDAARON PHARMACEUTICALS LTDOXOLOXALIPLATIN2MG/MLVENUS REMEDIES LTD --UNIT II HILL TOP INDUSTRIAL ESTATE JHARMAJRI EPIP PHASE I BHATOLI KALAN BADDI (H.P)INDIAPARENTERAL ORDINARY VIALS1.0X5.0 ML VIAL
566NDA/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 BLISTER
567NDA/MAL/HDP/1067MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDIBUPARAIBUPROFEN+PARACETAMOL200MG+ 250MG/10MLTORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506INDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE
568NDA/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 INDIAINDIAPARENTERAL ORDINARY AMPOULES1.0X10.0X10.0X1.0 ML AMPOULE
569NDA/MAL/HDP/1073GLENMARK PHARMACUTICALS LTDSTAR PHARMACEUTICALS LTDIBICAR-250BECLOMETASONE250MCG PER ACTUATIONGLENMARK PHARMACEUTICALS LTD (UNIT III).-UNIT III VILLAGE KISHANPURA,BADDI-NALAGARH ROAD TEHSIL BADDI,DISTT. SOLAN, HIMACHAL PRADESH -173 205 INDIA
INDIALUNG ADMINISTRATION METERED-DOSE INHALER1.0X200.0 METERED DOSE CANNISTER
570NDA/MAL/HDP/1075NECTAR LIFESCIENCES LTDAIVEEN (U) LIMITEDNECPIMECEFEPIME1000MGNECTAR LIFESCIENCES LTD UNIT VI-BHATOLIKALAN P.O BAROTIWALA DISTT SOLAN HIMACHAL PRADESH 173205INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0X1.0 G VIAL + 1*10 ML WATER FOR INJECTION
571NDA/MAL/HDP/1077NECTAR LIFESCIENCES LTDAIVEEN (U) LIMITEDNECTRAMCEFTRIAXONE1GNECTAR LIFESCIENCES LTD UNIT VI-BHATOLIKALAN P.O BAROTIWALA DISTT SOLAN HIMACHAL PRADESH 173205INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0X1.0 G VIAL + 1*10 ML WFI AMPOULE
572NDA/MAL/HDP/1078MICRO LABS LTDLABOREX UGANDA LIMITEDLEVOBACT INFUSIONLEVOFLOXACIN HEMIHYDRATE500MGAHLCON PARENTERALS (INDIA) LTD-SP-917-918, PHASE-III BHIWADI-301019, ALWAR, RAJASTHANINDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X100.0 ML BOTTLE
573NDA/MAL/HDP/1079AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOG-QUINE SYRUPQUININE HYDROCHLORIDE100MG/5MLAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE
574NDA/MAL/HDP/1080ALKEM LABORATORIES LIMITEDABACUS PHARMA (AFRICA) LIMITEDZOCEF 250 TABLETSCEFUROXIME AXETIL250MGALKEM LABORATORIES LIMITED.-VILLAGE THANA, BADDI, TEHSIL-NALAGARH, DISTT-SOLAN, (HP), INDIA-173205INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X6.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER
575NDA/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 BOTTLE
576NDA/MAL/HDP/1083GALPHA LABORATORIES LTDAIVEEN (U) LIMITEDCHOCOFER SYRUPIRON + FOLIC ACID50MG + 0.5MG /5MLGALPHA LABORATORIES LIMITED-VILLAGE – THANA BADDI, TEHSIL BADDI
SOLAN HIMACHAL PRADESH-173 205 INDIA
INDIAORAL LIQUID ORDINARY SYRUPS1.0X200.0 ML BOTTLE
577NDA/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 BLISTER
578NDA/MAL/HDP/1086NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDSYNOGEN TABLETSDIACEREIN + METHYL SULPHONYL METHANE + GLUCOSAMINE SULPHATE50MG +250MG + 750MGNEM LABORATORIES LIMITED-133 KRISHNA IND. ESTATE, VASAI (E),
THANE – 401 210, MAHARASHTRA – INDIA
INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER
579NDA/MAL/HDP/1087AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOCYCLINETETRACYCLINE3%W/WAGOG PHARMA LTD.-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIATOPICAL EXTERNAL OINTMENTS1.0X15.0 G TUBE
580NDA/MAL/HDP/1088GALPHA LABORATORIES LTDAIVEEN (U) LIMITEDRESTUMCEFUROXIME SODIUM750MGALKEM LABORATORIES LTD-VILLAGE – THANA, BADDI TEHSIL – NALAGARH, DIST-SOLAN (HP), INDIA – 173205INDIAPARENTERAL ORDINARY DRY VIALS1.0X750.0 MG VIAL
581NDA/MAL/HDP/1094MICRO LABS LTDLABOREX UGANDA LIMITEDGRAMOCEF-O-100CEFIXIME100MG/5MLMICRO LABS LTD--NO. 121-124 4TH PHASE K.I.A.D.B BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK BANGALORE 560 099INDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE
582NDA/MAL/HDP/1095MICRO LABS LTDLABOREX UGANDA LIMITEDEROSTINE-20EBASTINE20MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER
583NDA/MAL/HDP/1099GLENMARK PHARMACEUTICAL LTD.STAR PHARMACEUTICALS LTDMOMATE F CREAMFUSIDIC ACID+MOMETASONE FUROATE2.1%W/W + 0.1W/WGLENMARK PHARMACEUTICALS LTD UNIT II.-UNIT II VILLAGE BHATTANWALA NALAGARH DIST SOLAN HIMACHAL PRADESHINDIATOPICAL EXTERNAL CREAMS1.0X10.0 G TUBE
584NDA/MAL/HDP/1100AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOVIR SKIN CREAMACICLOVIR5% W/WAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIATOPICAL EXTERNAL CREAMS1.0X10.0 G TUBE,1.0X5.0 G TUBE
585NDA/MAL/HDP/1102MATRIX UGANDA LTDROYAL PHARMA 2011 LIMITEDOVUREXCLOMIPHENE50MG Y.S.P INDUSTRIES (M) SDN BDH - LOT 3,5 & 7 P/7 SECTION 13 KAWASAN PERINDUSTRIAN BANDAR BARU BANGI 43000 KAJANG SELANGOR DARUL EHSANMALAYSIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER
586NDA/MAL/HDP/1103AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOCIN CREAMNEOMYCIN SULPHATE0.5% W/WAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE
587NDA/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 TUBE
588NDA/MAL/HDP/1106EVA PHARMAWIDE SPECTRUM ENTERPRISES (U) LIMITEDDIACEREINDIACEREIN50MGEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPTEGYPTORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER,1.0X2.0X10.0 CAPSULE BLISTER
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590NDA/MAL/HDP/1109DAWA LIMITEDSUPER MEDIC LTDDAWA-CPMCHLORPHENIRAMINE MALEATE2MG/5MLDAWA PHARMACEUTICALS LIMITED-PLOT 7879, BABA DOGO ROAD RUARAKAKENYAORAL LIQUID ORDINARY SYRUPS1.0X60.0 ML BOTTLE
591NDA/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 RUARAKAKENYATOPICAL EXTERNAL GELS AND SOLS1.0X20.0 G TUBE
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596NDA/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 VIAL
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598NDA/MAL/HDP/1124AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGO SCRUBCHLORHEXIDINE GLUCONATE4%W/VAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIATOPICAL EXTERNAL LIQUIDS1.0X1.0X500.0 ML BOTTLE
599NDA/MAL/HDP/1128LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDBTC KITFLUCONAZOLE + AZITHROMYCIN + SECNIDAZOLE150MG + 1G + 1GLINCOLN PHARMACEUTICALS L.T.D-TRIMUL ESTATE KHATRAJ 382721 GHANDINAGAR GUJARATINDIAORAL SOLID ORDINARY COMBINATION PACK TABLETS1.0X4.0 TABLET BLISTER
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603NDA/MAL/HDP/1139AGOG PHARMA LTD.GITTOES PHARMACEUTICALS LIMITEDAGOVATEBETAMETHASONE0.1%W/WAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE
604NDA/MAL/HDP/1140AGOG PHARMA LTD.GITTOES PHARMACEUTICALS LIMITEDAGOVATE-NBETAMETHASONE+NEOMYCIN SULPHATE0.1%W/W+0.5%W/WAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE
605NDA/MAL/HDP/1141LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDCALBONECALCIUM CARBONATE + COLECALCIFEROL250MG+125MG/5MLSAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE
606NDA/MAL/HDP/1142AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDCANDIZOLCLOTRIMAZOLE1%W/WAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIATOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE
607NDA/MAL/HDP/1143LINCOLN P'CALS LTDMETRO PHARMACEUTICALS LIMITEDLOSA-HLOSARTAN + HYDROCHLOROTHIAZIDE50MG + 12.5MGLINCOLN PHARMACEUTICALS LIMITED-10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
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608NDA/MAL/HDP/1147CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDVALAZYDVALSARTAN80MGCADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER
609NDA/MAL/HDP/1148CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDODIMONT 10MONTELUKAST10MGCADILA HEALTHCARE LIMITED -KUNDAIM INDUSTRIAL ESTATE,PLOT NO.203-213, KUNDAIM GOA, 403115, INDIAORAL SOLID ORDINARY COATED TABLETS1.0X10.0X10.0 TABLET BLISTER
610NDA/MAL/HDP/1149UNIVERSAL CORPORATION LTDDELMAW ENTERPRISES LIMITEDNEUROBAGABAPENTIN300MGUNIVERSAL CORPORATION LTD..-PLOT 13777 CLUB ROAD, PAST KIKUYUKENYAORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER
611NDA/MAL/HDP/1154SUN PHARMACEUTICAL INDUSTRIES LIMITEDSTAR PHARMACEUTICALS LTDBACQUREIMIPENEM + CILASTATIN500MG + 500MGSUN PHARMACEUTICAL INDUSTRIES LIMITED-INDUSTRIAL AREA NO.3, A.B. ROAD DEWAS, 455001 (MP), INDIA.

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612NDA/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 TUBE
613NDA/MAL/HDP/1157Y.S.P INDUSTRIES (M) SDN BHDROYAL PHARMA 2011 LIMITEDTRETINONTRETINOIN0.05%W/WY.S.P.INDUSTRIES(M)SBD,BHD-LOT 3,5,& 7,JALANP/7,SECTION13,KAWASAN PERINDUSTRIAN BANDAR BARUBANGI,43000 KAJANG SELANGOR DARUL EHSAN, MALAYSIAMALAYSIATOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE
614NDA/MAL/HDP/1159Y.S.P INDUSTRIES (M) SDN BHDROYAL PHARMA 2011 LIMITEDVORENDICLOFENAC SODIUM50MGY.S.P.INDUSTRIES(M)SBD,BHD-LOT 3,5,& 7,JALANP/7,SECTION13,KAWASAN PERINDUSTRIAN BANDAR BARUBANGI,43000 KAJANG SELANGOR DARUL EHSAN, MALAYSIAMALAYSIARECTAL SYSTEMIC SUPPOSITORIES1.0X2.0X5.0 SUPPOSITORY STRIP,1.0X10.0X10.0 SUPPOSITORY STRIP
615NDA/MAL/HDP/1160DAFRA PHARMA LTDLABOREX UGANDA LIMITEDDAFRACLAVAMOXYCILLIN + CLAVULANIC ACID875MG+125MGBILIM PHARMACEUTICALS--CERKEZKOY PLANT, 59500 CERKEZKOY, TEKIRDAGTURKEYORAL SOLID ORDINARY TABLETS1.0X2.0X5.0 TABLET BLISTER
616NDA/MAL/HDP/1163NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDFRUSEMIDEFUROSEMIDE40MGNEM LABORATORIES LIMITED-133 KRISHNA IND. ESTATE, VASAI (E),
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617NDA/MAL/HDP/1166PANACEA BIOTEC LTDABACUS PHARMA (AFRICA) LIMITEDDOLZEROTRAMADOL HYDROCHLORIDE + PARACETAMOL37.5MG + 325MGPANACEA BIOTEC LTD-MALPUR, BADDI, TEHSIL, NALAGARH, DIST. SOLAN (H.P) – 173 205INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER
618NDA/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 AMPOULE
619NDA/MAL/HDP/1168DAWA LIMITEDSUPER MEDIC LTDDAWA-CORT CREAMHYDROCORTISONE1%W/WDAWA LTD -BABA DOGO ROAD, RUARAKA P.O.BOX 16633-00620, NAIROBI KENYAKENYATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE
620NDA/MAL/HDP/1169ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDNEBI 5NEBIVOLOL HYDROCHLORIDE5MGARISTO PHARMACEUTCALS PVT LTD-PLOT NO.208 NEW INDUSTRIAL AREA NO.II MANDIDEEP 462046 RAISEN MADHYA PRADESHINDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER
621NDA/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 VIAL
622NDA/MAL/HDP/1178HETERO DRUGS LTDABACUS PHARMA (AFRICA) LIMITEDTENOFOVIRTENOFOVIR DISOPROXIL FUMARATE300MGHETERO LABS LTD-22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESHINDIAORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET CONTAINER
623NDA/MAL/HDP/1179MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDOVITRELLECHORIOGONADOTROPIN ALFA250MCG/0.5MLMERCK SERONO SA-1170 AUBONNE(SWITZERLAND),MERCK SERONO S.P.A-VIA DELLE MAGNOLIE,15.70026 MODUGNO (BA).ITALYSWITZERLANDPARENTERAL ORDINARY PRE-FILLED SYRINGES1.0X1.0 PREFILLED SYRINGE CARTON
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625NDA/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 BOTTLE
626NDA/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 BOTTLE
627NDA/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 BOTTLE
628NDA/MAL/HDP/1187GALPHA LABORATORIES LTDAIVEEN (U) LIMITEDKEFTAZ-1000CEFTAZIDIME1 GALKEM LABORATORIES LTD-VILLAGE – THANA, BADDI TEHSIL – NALAGARH, DIST-SOLAN (HP), INDIA – 173205INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0X1.0 G VIAL + 1*10 ML WATER FOR INJECTION
629NDA/MAL/HDP/1194VENUS REMEDIES LTDHARLEYS UGANDA LIMITEDPISAPIPERACILLIN + TAZOBACTAM4000MG/VIAL + 500MG/VIALVENUS REMEDIES LTD, UNIT II,-HILL TOP INDUSTRIAL ESTATE, JHARMAJTI, EPIP, PHASE-1 (EXTENSION), BHATOLI KALAN, BADDI -HPINDIAPARENTERAL ORDINARY VIALS1.0X1.0X30.0 ML VIAL
630NDA/MAL/HDP/1195UNIVERSAL CORPORATION LTDHARLEYS UGANDA LIMITEDALTRINECETIRIZINE5MG/5MLUNIVERSAL CORPORATION LIMITED -PLOT 13777 KIKUYU ROAD, KIKUYU TOWN, PAST POST OFFICEKENYAORAL LIQUID ORDINARY SYRUPS1.0X60.0 ML BOTTLE,1.0X30.0 ML BOTTLE
631NDA/MAL/HDP/1196UNIVERSAL CORPORATION LTDDELMAW ENTERPRISES LIMITEDACNESOLTRETINOIN0.05%W/WUNIVERSAL CORPORATION LTD..-PLOT 13777 CLUB ROAD, PAST KIKUYUKENYATOPICAL EXTERNAL CREAMS1.0X25.0 G TUBE
632NDA/MAL/HDP/1206THE METHOLATUM CO. LTDHARLEYS UGANDA LIMITEDDEEP RELIEFIBUPROFEN + MENTHOL5%W/W + 3% W/WTHE MENTHOLATUM CO. LTD. -1 REDWOOD AVE PEEL PARK CAMPUS EAST KILBRIDEUNITED KINGDOMTOPICAL EXTERNAL OTHER GELS/SOLS1.0X50.0 G CONTAINER,1.0X15.0 G CONTAINER,1.0X30.0 G CONTAINER
633NDA/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
634NDA/MAL/HDP/1209MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDARBITEL-80TELMISARTAN80MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER
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636NDA/MAL/HDP/1212GUILIN PHARMACEUTICALS CO.LTDSTAR PHARMACEUTICALS LTDGLINTHERARTEMETHER80MG/MLGUILIN PHARMACEUTICAL CO.,LTD-NO 43 QILIDIAN ROAD GUILIN 541002, GUANGXICHINAPARENTERAL ORDINARY I M AMPOULES1.0X6.0X1.0 ML AMPOULE
637NDA/MAL/HDP/1214FERRER INTERNACIONAL S.ALABOREX UGANDA LIMITEDNUCLEO C.M.P FORTECYTIDINE+URIDINE5MG+3MGFERRER INTERNACIONAL, S.A-JOAN BUCSALA 1-9, 08173 SANT CUGAT DEL VALLES, BARCELONA, SPAINSPAINORAL SOLID ORDINARY CAPSULES1.0X2.0X15.0 CAPSULE BLISTER
638NDA/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 BLISTER
639NDA/MAL/HDP/1217SANOFI AVENTISLABOREX UGANDA LIMITEDINSUMAN BASALRECOMBINANT HUMAN INSULIN100 IU/MLSANOFI-AVENTIS DEUTSCHLAND GMBH -INDUSTRIEPARK HOECHST, BRUNINGSTRASSEN, BUILDING
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640NDA/MAL/HDP/1218BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDGSUNATE-50ARTESUNATE50MGBLISS INDASI LIFESCINCES PRIVATE LIMITED - -PLOT 73-76 SILVER INDUSTRIAL ESTATE,
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641NDA/MAL/HDP/1219DENK PHARMA GMB H &CO. KGBENLE CONSULT LIMITEDTORAS-DENK 5TORASEMIDE5MGDENK PHARMA GMBH &CO.KG--PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANYGERMANYORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER
642NDA/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 BLISTER
643NDA/MAL/HDP/1222MIRACALUS PHARMA PVT.LTDAIVEEN (U) LIMITEDBUPIVACAINE HYDROCHLORIDE IN DEXTROSE USPBUPIVACAINE HYDROCHLORIDE20MG/4MLNAPROD LIFE SCIENCES (PVT) LIMITED-PLOT G-17/1 MIDC TARAPUR BOISAR, DIST. THANE-401506 MAHARASTRA, INDIA INDIAPARENTERAL ORDINARY AMPOULES1.0X5.0X4.0 ML AMPOULE
644NDA/MAL/HDP/1223REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDWHITFIELD'S OINTMENTBENZOIC ACID + SALICYLIC ACID6%W/W + 3%W/WREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYATOPICAL EXTERNAL OINTMENTS1.0X1.0X25.0 G TUBE
645NDA/MAL/HDP/1226AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITEDROYAL PHARMA 2011 LIMITEDSALBUTAMOLSALBUTAMOL4MGSTRIDES ARCOLAB LIMITED .-DEWAN & SONS IND. AREA, VEOOR, PALGHAR, MAHARASTRAINDIAORAL SOLID ORDINARY TABLETS1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER
646NDA/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 STRIP
647NDA/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, INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X4.0X6.0 TABLET BLISTER
648NDA/MAL/HDP/1230MEDOPHARM PRIVATE LIMITEDPLANET PHARMACEUTICALS UGANDA LTDLOXAMPAMPICILLIN + CLOXACILLIN250 MG + 250 MGMEDOPHARM PVT LTD.-NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADUINDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER
649NDA/MAL/HDP/1231NORVIK ENTERPRISES LIMITEDPLANET PHARMACEUTICALS UGANDA LTDMEDOMOX 125AMOXYCILLIN125MG/5MLMEDOPHARM PVT LTD.-NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADUINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE
650NDA/MAL/HDP/1234MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDBISACODYL TABLETS BPBISACODYL5MGMACLEODS PHARMACEUTICALS LTD.-PLOT NO. 25-27 SURVEY NO. 366,
PREMIER INDUSTRIAL ESTATE, KACHIGAM,
DAMAN (UT) - 396210, INDIA.
INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X10.0X10.0 TABLET STRIP
651NDA/MAL/HDP/1238PHARMACARE LIMITEDBETA HEALTHCARE UGANDA LIMITEDSEPTRIN INJECTIONCO-TRIMOXAZOLE480MG/5MLDRAXIS PHARMA INC.- QUEBEC, CANADACANADAPARENTERAL ORDINARY AMPOULES1.0X10.0X5.0 ML AMPOULE
652NDA/MAL/HDP/1239IPCA LABORATORIES LTDMEDVIN PHARMA LIMITEDPECTYLIN-CDIPHENHYDRAMINE HYDROCHLORIDE+AMMONIUM HYDROCHLORIDE+SODIUM CITRATE+MENTHOL14MG+135MG+57MG+1.1MG IPCA LABORATORIES LTD,PLOT NO. T-139 -SEJAVTA, RATLAM-457 002 (M.P.) INDIAINDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE
653NDA/MAL/HDP/1242AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDTOPHEN-100PHENYTOIN100MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
654NDA/MAL/HDP/1243DENK PHARMA GMBH & CO KGBENLE CONSULT LIMITEDLEVO DENK 250LEVOFLOXACIN HEMIHYDRATE250MGROTTENDORF PHARMA GMBH-OSTENFELDER STRASSE 51-61 59320 ENNIGERLOH GERMANYGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER
655NDA/MAL/HDP/1244GLENMARK PHARMACUTICALS LTDSTAR PHARMACEUTICALS LTDFLEXILOR SRLORNOXICAM16MGGLENMARK PHARMACEUTICAL LIMITED;--VILLAGE KISHANPURA,BADDI-NALAGARH ROAD TEHSIL BADDI,DISTT. SOLAN, HIMACHAL PRADESH -174 101 INDIAINDIAORAL SOLID RETARD FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER
656NDA/MAL/HDP/1245GLENMARK PHARMACUTICALS LTDSTAR PHARMACEUTICALS LTDFLEXILOR P8LORNOXICAM + PARACETAMOL8MG + 500MGGLENMARK PHARMACEUTICAL LIMITED;--VILLAGE KISHANPURA,BADDI-NALAGARH ROAD TEHSIL BADDI,DISTT. SOLAN, HIMACHAL PRADESH -174 101 INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER
657NDA/MAL/HDP/1246GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDGLEMONT CT 4MONTELUKAST4MGGLENMARK PHARMACEUTICALS LTD-VILLAGE: KISHANPURA, BADDI NALAGARH DISTRICT SOLAN - 174101, INDIAINDIAORAL SOLID ORDINARY CHEWABLE TABLETS1.0X10.0X10.0 TABLET BLISTER
658NDA/MAL/HDP/1247AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDPROCIPCYPROHEPTADINE4MGAGOG PHARMA LTD.-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIAORAL SOLID ORDINARY TABLETS1.0X2.0X5.0X10.0 TABLET BLISTER
659NDA/MAL/HDP/1252MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDZOYSILDENAFIL50MGTORQUE PHAMACEAUTICALS PVT LTD-VILL ISSAPUR P.O DAPPAR INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X1.0X4.0 TABLET BLISTER
660NDA/MAL/HDP/1254COSMOS LTDASTRA PHARMA (U) LIMITEDCOSATRIM TABLETSCO-TRIMOXAZOLE480MGCOSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREAKENYAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER
661NDA/MAL/HDP/1255CIPLA LTDQUALITY CHEMICALS LTD - HUMANNIFELAT RETARDNIFEDIPINE20MGCIPLA LTD-MIDC PATALGANGA 410 220 DIST. RAIGADINDIAORAL SOLID RETARD TABLETS1.0X10.0X10.0 TABLET BLISTER
662NDA/MAL/HDP/1256SIRMAXO CHEMICALS PVT LTDSUPER MEDIC LTDSANIQUAD PVP TPOVIDONE IODINE10%W/WSIRMAXO CHEMICALS PVT LTD-PLOT NO. E-35. TARAPRU MIDC BOISAR, THANE, MUMBAI, INDIAINDIATOPICAL EXTERNAL LIQUIDS1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X1000.0 ML BOTTLE
663NDA/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 BLISTER
664NDA/MAL/HDP/1260BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDDIABETAGLIBENCLAMIDE5MGBLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER
665NDA/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 TUBE
666NDA/MAL/HDP/1265AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDCOMBIPLEXVITAMIN B1 + VITAMIN B2 + NICOTINAMIDE + VITAMIN B61.0 MG + 1.0 MG + 15 MG + 0.5 MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY COATED TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
667NDA/MAL/HDP/1270MATRIX LABORATORIES LTDVITACARE LTDPARAPARACETAMOL500MGHEBEI (ZHANGJIAKOU) KAIWEI PHARMACEUTICAL CO-27 LINGYUAN STREET, ZHANGJIAKOU, QIAO DONG DISTRICT HEBEI PROVINCE - PEOPLES’ REPUBLIC OF CHINAINDIAORAL SOLID ORDINARY TABLETS1.0X100.0X10.0 CAPSULE BLISTER, 1.0X1000.0 CAPSULE CONTAINER
668NDA/MAL/HDP/1274SURGE LAB (PVT) LIMITEDJEET PHARMACEUTICALS LIMITEDROMYCINAZITHROMYCIN250MGNABIQASIM INDUSTRIES (PVT) LTD--17/24,KORANGI INDUSTRIAL AREA, KORANGI, KARACHI- PAKISTAN.PAKISTANORAL SOLID ORDINARY CAPSULES1.0X1.0X6.0 CAPSULE BLISTER
669NDA/MAL/HDP/1275REMEDICA LTDGOODMAN INTERNATIONAL LTDNIFELAT 10 F.C TABLETSNIFEDIPINE10MGREMEDICA LIMITED -AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUSCYPRUSORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER
670NDA/MAL/HDP/1277SANOTI AVENTISLABOREX UGANDA LIMITEDINSUMAN RAPIDINSULIN HUMAN100 IU/MLSANOFI-AVENTIS DEUTSCHLAND GMBH-INDUSTRIEPARK HOECHST, BRUNINGSTRASSEN, BUILDING D-65926 FRANKFURT AM MAIN, GERMANY GERMANYPARENTERAL ORDINARY S C VIALS1.0X5.0 ML VIAL
671NDA/MAL/HDP/1278GUILIN PHARMACEUTICALS CO.LTDSTAR PHARMACEUTICALS LTDD-ARTEPPDIHYDROARTEMESININ + PIPERAQUINE PHOSPHATE40MG +320MGGUILIN PHARMACEUTICAL CO LTD-NO.43 QILIDIAN ROAD GUILIN 541004 GUANGXICHINAORAL SOLID ORDINARY TABLETS1.0X9.0 TABLET BLISTER,1.0X8.0 TABLET BLISTER
672NDA/MAL/HDP/1282ZEE PHARMACEUTICALS LTDZEE PHARMACEUTICALS LIMITEDLOSABERGLOSARTAN POTASSIUM50MGTHE MADRAS PHARMACEUTICALS..-NO. 137B, OLD MAHABALIPURAM ROAD, KARAPAKKAM, CHENNAI 600096INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER
673NDA/MAL/HDP/1291BAYER SCHERING PHARMASURGIPHARM (U) LIMITEDULTRAVIST-300IOPROMIDE300MG/MLBAYER PHARMA A.G-MULLERSTRASSE 178, 13353 BERLIN, GERMANYGERMANYPARENTERAL ORDINARY VIALS1.0X50.0 ML VIAL,1.0X100.0 ML VIAL
674NDA/MAL/HDP/1293ZEE PHARMACEUTICALS LTDZEE PHARMACEUTICALS LIMITEDZEEGRA - 100SILDENAFIL CITRATE100MGTHE MADRAS PHARMACEUTICALS..-NO. 137B, OLD MAHABALIPURAM ROAD, KARAPAKKAM, CHENNAI 600096INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X4.0 TABLET BLISTER
675NDA/MAL/HDP/1294BAYER SCHERING PHARMASURGIPHARM (U) LIMITEDULTRAVIST 370IOPROMIDE370MG/MLBAYER PHARMA A.G-MULLERSTRASSE 178, 13353 BERLIN, GERMANYGERMANYPARENTERAL ORDINARY VIALS1.0X100.0 ML VIAL,1.0X50.0 ML VIAL
676NDA/MAL/HDP/1297CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDOLMY 40OLMESARTAN40MGCADILA HEALTHCARE LTD -KUNDAIM INDUSTRIAL ESTATE PONDA GOA 403 401INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER
677NDA/MAL/HDP/1300KOPRAN LIMITEDTATA UGANDA LIMITEDATENOLOL-100ATENOLOL100MGKOPRAN LIMITED-VILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X16.0X14.0 TABLET BLISTER
678NDA/MAL/HDP/1302CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDHIPEN CAPSULESAMOXYCILLIN250MGSPARSH BIO-TECH PVT. LIMITED-PLOT NO. 1;SURVEY NO. 242/243/244,LAKHABAVAD,JAMNAGAR-361 006, INDIA.
INDIAORAL SOLID ORDINARY CAPSULES1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER
679NDA/MAL/HDP/1304MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDDIAPRIDE PLUS 2GLIMEPIRIDE+ METFORMIN1MG + 500MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER
680NDA/MAL/HDP/1307MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDARBITEL 40TELMISARTAN40MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER
681NDA/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 BLISTER
682NDA/MAL/HDP/1315ZEE PHARMACEUTICALS LTDZEE PHARMACEUTICALS LIMITEDZESOZ-20ESOMEPRAZOLE20MGTHE MADRAS PHARMACEUTICALS..-NO. 137B, OLD MAHABALIPURAM ROAD, KARAPAKKAM, CHENNAI 600096INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER
683NDA/MAL/HDP/1319REMEDICA LTDGOODMAN INTERNATIONAL LTDZESTAVAL 200 F.C TABLETSALBENDAZOLE200MGREMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHARCYPRUSORAL SOLID ORDINARY FILM-COATED TABLETS50.0X2.0 TABLET BLISTER
684NDA/MAL/HDP/1324MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDTOOTH HEALMULTI INGREDIENTMULTI INGREDIENTTORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506INDIAORAL LIQUID ORDINARY LIQUIDS1.0X1.0X18.0 ML BOTTLE
685NDA/MAL/HDP/1325MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDLAMIVUDINE + ZIDOVUDINELAMIVUDINE + ZIDOVUDINE150MG + 300MGMACLEODS PHARMACEUTICALS LTD., NO. 25-27-PLOT NO. 25-26-27, SURVEY NO.366, PREMIER INDUSTRIAL ESTATE ., DAMAN - 396210, KACHIGAM, DAMANINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X60.0 TABLET BOTTLE
686NDA/MAL/HDP/1326IDAKIMSY MEDS LTDCO-TRIMOXAZOLE 480MGCO-TRIMOXAZOLE480MGMEDOPHARM--34-B, INDUSTRIAL AREA, MALUR 563 160 KARNATAKE,INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X100.0 TABLET BLISTER
687NDA/MAL/HDP/1330IPCA LABORATORIES LTDMEDVIN PHARMA LIMITEDRAPICLAV-625AMOXYCILLIN+CLAVULANIC ACID500MG+125MGIPCA LABORATORIES LTD,.-PLOT 69 TO 72 (B), SECTOR II, KASEZ, GANDHIDHAM - 370230, GUJARATINDIAORAL SOLID ORDINARY TABLETS1.0X5.0X2.0 TABLET STRIP,1.0X7.0X3.0 TABLET STRIP
688NDA/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, PAKISTANPAKISTANTOPICAL EXTERNAL OINTMENTS1.0X15.0 G TUBE,1.0X5.0 G TUBE
689NDA/MAL/HDP/1335INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDPREGATASPREGABALIN75MGINTAS PHARMACEUTICALS LTD-CAMP ROAD SELAQUI DEHRADUNINDIAORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER
690NDA/MAL/HDP/1337FOURRTS(INDIA) LABORATORIES PVT.LIMITEDDELMAW ENTERPRISES LIMITEDFOURTS BTHIAMINE +RIBOFLAVIN + PYRIDOXINE + NICOTINAMIDE + FOLIC ACID + ASCORBIC ACID + COLECALCIFEROL + ACETYL CYSTEINE + GLYCINE + GLUTAMIC ACID + CHROMIUM + VANADIUM + ZINC + SELENIUM10MG + 10MG + 3MG + 50MG + 1MG + 75MG + 400IU + 25MG +25MG +MG +200MCG + 100MCG + 55MG +100MCGFOURRTS INDIA LABORATORIES PVT. LIMITED-VANDALUR ROAD, KELAMBAKKAM 603103, CHENNAI, TAMIL NADU, INDIAINDIAORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER
691NDA/MAL/HDP/1338LEBEN LABORATORIES PVT LTDANDYCO PHARMACY (UGANDA) LTDGRISEBEN 500GRISEOFULVIN500 MGLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER
692NDA/MAL/HDP/1341AUROLABSWASTIK PHARMACEUTICAL LTDG-FLOXGATIFLOXACIN SESQUIHYDRATE0.3%W/VAUROLAB-NO 1 SIVAGANGAI MAIN ROAD, VEERAPANJAN MADURAI – 625 020 TAMIL NADU, INDIAINDIAOPHTHALMIC LIQUIDS1.0X5.0 ML VIAL
693NDA/MAL/HDP/1345ALKEM LABORATORIES LIMITEDABACUS PHARMA (AFRICA) LIMITEDSWICH-200CEFPODOXIME200MGALKEM LABORATORIES LTD-VILLAGE – THANA, BADDI TEHSIL – NALAGARH, DIST-SOLAN (HP), INDIA – 173205INDIAORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER
694NDA/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 INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
695NDA/MAL/HDP/1347MICRO LABS LIMITEDLABOREX UGANDA LIMITEDORNILOXORNIDAZOLE + OFLOXACIN500MG + 200MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X10.0 TABLET BLISTER
696NDA/MAL/HDP/1348TORRENT PHARAMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.VALPARIN CHRONO 500SODIUM VALPROATE (CONTROLLED RELEASE)500MGTORRENT PHARMACEUTICAL LTD-AHMEDABAD-MEHSANA HIGHWAY,TALUKA-KADI,DIST.MEHSANA,INDRAD-382721INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET STRIP
697NDA/MAL/HDP/1355PIRAMAL HEALTHCARE LTDTATA UGANDA LIMITEDSEVOFLURANESEVOFLURANE100% V/VPIRAMAL ENTERPRISES LTD, INDIA-DIGWAL VILLAGE KOHIR MENDAL MEDAK DISTRICT,ANDHRA PRADESHINDIAOTHER SYSTEMIC LIQUID INHALATIONS1.0X250.0 ML BOTTLE
698NDA/MAL/HDP/1359KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDDIFENAC-100 SRDICLOFENAC SODIUM100MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD-PLOT M 444B STRETCHER ROAD NTINDAUGANDAORAL SOLID RETARD CAPSULES1.0X10.0 CAPSULE BLISTER
699NDA/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 INDIAINDIAORAL SOLID ORDINARY SOLUBLE TABLETS1.0X60.0 TABLET CONTAINER
700NDA/MAL/HDP/1361SWISS PARENTERALS PVT. LTD.SHREEJI PHARMACEUTICALS LIMITEDFALCI CAREARTESUNATE120MGSWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIAINDIAPARENTERAL ORDINARY DRY VIALS1.0X30.0 MG VIAL + 1*5ML OF 0.9%W/V NACL AMPOULE + 1*1ML OF 5%W/V NAHCO3 AMPOULE
701NDA/MAL/HDP/1362MICRO LABS LIMITEDLABOREX UGANDA LIMITEDBACTOCLAV-1000AMOXICILLIN + CLAVULANATE875 MG + 125 MGMICRO LABS LIMITED -PLOT 16 VEERASANDRA IND. AREA,ANEKAL TALUK,BANGALORE INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X7.0 TABLET STRIP
702NDA/MAL/HDP/1367DAWA LIMITEDSUPER MEDIC LTDACEPARACECLOFENAC + PARACETAMOL100 MG + 500 MGDAWA LTD-BABA DOGO ROAD RUARAKAKENYAORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER
703NDA/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 BOTTLE
704NDA/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 AMPOULE
705NDA/MAL/HDP/1377OTSUKA PHARMACEUTICAL INDIA PRIVATE LIMITEDREDDYS PHARMA LIMITEDWATER FOR INJECTIONWATER FOR INJECTIONN/AOTSUKA PHARMACEUTICAL INDIA PRIVATE LTD-VILLAGE – VASANA – CHACHARWADIP, TAL: SANAND, AHMADABADINDIAPARENTERAL ORDINARY AMPOULES1.0X10.0 ML AMPOULE
706NDA/MAL/HDP/1380KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDHYCORT CREAMHYDROCORTISONE1%W/WKAMPALA PHARMECEUTICALS INDUSTRIES LTD.-PLOT M444B STRETCHER RD, NTINDA KLA UGANDAUGANDATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE,1.0X30.0 G TUBE
707NDA/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 GOAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X60.0 TABLET BOTTLE
708NDA/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 GOAINDIAORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS1.0X60.0 TABLET BOTTLE
709NDA/MAL/HDP/1387INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDLAN-30LANSOPRAZOLE30MGINTAS PHARMACEUTICALS LTD-CAMP ROAD SELAQUI DEHRADUNINDIAORAL SOLID ORDINARY CAPSULES1.0X1.0X5.0X10.0 CAPSULE STRIP
710NDA/MAL/HDP/1389UNIVERSAL CORPORATION LTDHARLEYS UGANDA LIMITEDNELSTATNYSTATIN100000 I.U/MLUNIVERSAL CORPORATION LIMITED -PLOT 13777 KIKUYU ROAD, KIKUYU TOWN, PAST POST OFFICEKENYAORAL TOPICAL SUSPENSIONS1.0X30.0 ML BOTTLE
711NDA/MAL/HDP/1390ASTRA ZENECAMACNAUGHTON LIMITEDCRESTORROSUVASTATIN CALCIUM5MGIPR PHARMACEUTICALS INC,-LOT 17 INDUSTRIAL PARK PUERTO RICO, SAN ISIDRO, PUERTO RICOPUERTO RICOORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X14.0 TABLET BLISTER
712NDA/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 CARTON
713NDA/MAL/HDP/1395ASTRA ZENECA ABMACNAUGHTON LIMITEDNEXIUM 40MG IVESOMEPRAZOLE40MG/5MLASTRA ZENECA--KVARNBERGAGATAN12, SE-151 SODERTALIJESWEDENPARENTERAL ORDINARY VIALS1.0X1.0X5.0 ML VIAL,1.0X10.0X5.0 ML VIAL
714NDA/MAL/HDP/1397ASTRAZENECAMACNAUGHTON LIMITEDPLENDILFELODIPINE10MGASTRAZENECA AB,-GARTUNA & SNACKVIKEN STOCKHOLMSWEDENORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET CONTAINER
715NDA/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 PRADESHINDIALUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER1.0X200.0 METERED DOSE CANNISTER
716NDA/MAL/HDP/1400MEGA LIFESCIENCES (AUSTRALIA) PTY LTDABACUS PHARMA (AFRICA) LIMITEDPANFOR SR 500METFORMIN HYDROCHLORIDE500MGINVENTIA HEALTHCARE PRIVATE LIMITED-F1-F1/1, ADDITIONAL AMBERNATH MIDC, AMBERNATH
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MAHARASHTRA, INDIA.
INDIAORAL SOLID RETARD TABLETS1.0X5.0X20.0 TABLET BLISTER
717NDA/MAL/HDP/1402MEGA LIFESCIENCES (AUSTRALIA) PTY LTDABACUS PHARMA (AFRICA) LIMITEDPANFOR SR 1000METFORMIN HYDROCHLORIDE1000MGINVENTIA HEALTHCARE PRIVATE LIMITED-F1-F1/1, ADDITIONAL AMBERNATH MIDC, AMBERNATH
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MAHARASHTRA, INDIA.
INDIAORAL SOLID RETARD TABLETS1.0X5.0X20.0 TABLET BLISTER
718NDA/MAL/HDP/1403VHB MEDI SCIENCES LTDLLOYDS PHARMACY UGANDA LTD.DOMAXIN-RD 10MGDOXORUBICIN HCL10MGVHB MEDI SCIENCES LTD-PLOT 20, 21, 22 & 49,50, 51. INTEGRATED INDUSTRIAL AREA SECTOR 5, RUDRAPUR, UTTARAKHAND - INDIAINDIAPARENTERAL ORDINARY VIALS1.0X10.0 MG VIAL
719NDA/MAL/HDP/1404MIRACALUS PHARMA PVT.LTDAIVEEN (U) LIMITEDNAPRODOX-10DOXORUBICIN HCL100MGNAPROD LIFE SCIENCES (PVT) LIMITED-PLOT G-17/1 MIDC TARAPUR BOISAR, DIST. THANE-401506 MAHARASTRA, INDIA INDIAPARENTERAL ORDINARY VIALS1.0X5.0 ML VIAL
720NDA/MAL/HDP/1406LEBEN LABORATORIES PVT LTDANDYCO PHARMACY (UGANDA) LTDCEBAY DRY SYRUPCEFIXIME TRIHYDRATE50MG/5MLLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE
721NDA/MAL/HDP/1407PHARMATHEN S.AGOODMAN INTERNATIONAL LTDBELIFAXOMEPRAZOLE20MGPHARMATHEN S.A-6,DERVENAKION STR,PALLINI,AHICA GREECEGREECEORAL SOLID ORDINARY CAPSULES1.0X14.0 CAPSULE BOTTLE
722NDA/MAL/HDP/1408TORRENT PHARAMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.ROSUCORROSUVASTATIN20MGTORRENT PHARMACEUTICALS LTD-VILLAGE. BHUD-MAKHNU MAJRA, TEHSIL: BADDI 173205 DIST SOLAN (H.P)INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER
723NDA/MAL/HDP/1409SURGE LAB (PVT) LIMITEDJEET PHARMACEUTICALS LIMITEDROMYCINAZITHROMYCIN200MG/5MLNABIQASIM INDUSTRIES (PVT) LTD--17/24,KORANGI INDUSTRIAL AREA, KORANGI, KARACHI- PAKISTAN.PAKISTANORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X1.0X15.0 ML BOTTLE
724NDA/MAL/HDP/1411LEBEN LABORATORIES PVT LTDANDYCO PHARMACY (UGANDA) LTDCIPIUMCHLORPHENIRAMINE4MGLEBEN LAB PVT LTD-L4 PHASE 111 MIDCS AKOLA 444104 MAHARASTRA INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X20.0 TABLET BLISTER
725NDA/MAL/HDP/1413BETA HEALTHCARE INTERNATIONAL LTDBETA HEALTHCARE UGANDA LIMITEDPODINE MOUTH WASHPOVIDONE IODINE0.1%W/VBETA HEALTHCARE INTERNATIONAL LTD - -PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYAKENYAORAL TOPICAL LIQUIDS1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE
726NDA/MAL/HDP/1415ASTRA ZENECAMACNAUGHTON LIMITEDATACANDCANDESARTAN32MGASTRA ZENECA SWEDEN OPERATIONS-TABLET PRODUCTION SE-151 85, GARTUNAVAGEN, SODERTALJE
SWEDENORAL SOLID ORDINARY TABLETS1.0X2.0X14.0 TABLET BLISTER
727NDA/MAL/HDP/1417GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDMILICAL TABLETSCALCIUM CITRATE + VITAMIN D31000MG +200 I.UGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,DINDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER
728NDA/MAL/HDP/1418NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDAMINOPHYLLINE TABLETSAMINOPHYLLINE100MGNEM LABORATORIES PVT LTD-133 KRISHNA INDUSTRIAL ESTATE VASAI (E) DIST THANE 401 210 MAHARASHTRAINDIAORAL SOLID ORDINARY TABLETS1.0X100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
729NDA/MAL/HDP/1419GLOBAL NAPI PHARMACEUTICALSWIDE SPECTRUM ENTERPRISES (U) LIMITEDSINOPRIL 10LISINOPRIL10MGGLOBAL NAPI PHARMACEUTICALS -2ND INDUSTRIAL ZONE, NO.40, ST. NO 18, 6TH OCTOBER, GIZA, EGYPTORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER
730NDA/MAL/HDP/1420IVEE INFUSIONS EPZ LTDASTRA PHARMA (U) LIMITEDSODIUM CHLORIDE + GLUCOSESODIUM CHLORIDE + GLUCOSE0.9%W/V + 5%W/VIVEE INFUSION EPZ LTD-ATHI RIVER EXPORT PROCESSING ZONE LR NO. 18474184 NAIROBIKENYAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X500.0 ML BOTTLE
731NDA/MAL/HDP/1423SANDOZ KENYA C/O NOVARTIS PHARMA SERVICES INCSURGIPHARM (U) LIMITEDCURAMAMOXYCILLIN + POTASSIUM CLAVULANATE500MG+125MGSANDOZ GMBH-BIOCHEMIESTRASSE 10, A6250 KUNDL, TYROL, AUSTRIA AUSTRIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X7.0X2.0 TABLET BLISTER
732NDA/MAL/HDP/1425LEBEN LABORATORIES PVT.LTDANDYCO PHARMACY (UGANDA) LTDL-TRIMCOTRIMOXAZOLE240MG/5MLLEBEN LABORATORIES PVT. LTD-L-4, PHASE –III, M.I.D.C, INDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X60.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE
733NDA/MAL/HDP/1426LEBEN LABORATORIES PVT.LTDANDYCO PHARMACY (UGANDA) LTDMETROLEBMETRONIDAZOLE200MGLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER
734NDA/MAL/HDP/1427AGOG PHARMA LTD.GITTOES PHARMACEUTICALS LIMITEDTENA-50ATENOLOL50MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X28.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER
735NDA/MAL/HDP/1431INTAS PHARMACUITICALS LTDNORVIK ENTERPRISES LIMITEDTORTAS 10TORSEMIDE10MGINTAS PHARMACEUTICALS LIMITED -CAMP ROAD, SELAQUI-248197,DEHRADUN UTTARAKHAND, INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER
736NDA/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 INDIAINDIAOTIC DROPS1.0X10.0 ML VIAL
737NDA/MAL/HDP/1433BAYER PHARMA AGSURGIPHARM (U) LIMITEDNORISTERATNORETHISTERONE ENANTATE200MGBAYER PHARMA A.G-MULLERSTRASSE 178, 13353 BERLIN, GERMANYGERMANYPARENTERAL ORDINARY VIALS1.0 ML PRE- FILLED SYRINGE,1.0X100.0X1.0 ML VIAL
738NDA/MAL/HDP/1436MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDCONCOR 10BISOPROLOL HEMIFUMARATE10MGMERCK KGAA-250 FRANKFRUTER STRASSE 250-64293 DARMSTADT,WINTHROP PHARMACEUTICALS(PTY) LTD,-315 WATLOO ROAD,WATLOO,PRETORIA,SOUTHAFRICA (FPP SECONDARY PACKAGING,FPP RELEASE/QC TESTING SITE)GERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER
739NDA/MAL/HDP/1445CADILA PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.AXONE 1000CEFTRIAXONE SODIUM1000MGCADILA PHARMACEUTICALS LTD.-1389, TRASAD ROAD, DHOLKA 387810 DISTRICT AHMEDABAD GUJARAT STATEINDIAPARENTERAL ORDINARY DRY VIALS1.0X1000.0 MG VIAL
740NDA/MAL/HDP/1446RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDVITAMIN B COMPLEXVITAMINS B1 + B2 + B6 + NIACINAMIDE0.5 MG + 0.5MG + 7.5MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER
741NDA/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 BLISTER
742NDA/MAL/HDP/1450GLAXOSMITHKLINE LIMITED LIKONIUNITED HEALTHCARE DISTRIBUTORS LTDVOLTAREN EMULGEL 1%DICLOFENAC DIETHYLAMMONIUM1%W/VNOVARTIS CONSUMER HEALTH SA-CH-1260 NYON SWTZERLANDSWITZERLANDTOPICAL EXTERNAL GELS AND SOLS1.0X20.0 G TUBE,1.0X50.0 G TUBE
743NDA/MAL/HDP/1451NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDVOLTAREN INJECTIONDICLOFENAC25MG/MLNOVARTIS PHARMA STEIN AG-SCHAFFHARVSERTRASSE CH-4332 STEIN SWITZERLAND.SWITZERLANDPARENTERAL ORDINARY AMPOULES1.0X3.0 ML AMPOULE
744NDA/MAL/HDP/1452ASTRA ZENECAMACNAUGHTON LIMITEDZESTORETICLISINOPRIL/HYDROCHLOROTHIAZIDE20MG/12.5MGASTRAZENECA MACCLESFIELD-CHESHIREUNITED KINGDOMORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X14.0 TABLET BLISTER
745NDA/MAL/HDP/1453ZEE PHARMACEUTICALS LTDZEE PHARMACEUTICALS LIMITEDZESOZ-40ESOMEPRAZOLE40MGMADRAS PHARMACEUTICALS -137-B, OLD MAHABALIPURAM ROAD, KARAPAKKAM, CHENNAI – 600 096, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER
746NDA/MAL/HDP/1454RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDPAINEXPARACETAMOL + ASPIRIN + CAFFEINE500MG + 400MG + 50 MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL SOLID ORDINARY TABLETS1.0X25.0X4.0 TABLET STRIP
747NDA/MAL/HDP/1456FOURRTS(INDIA) LABORATORIES PVT.LIMITEDDELMAW ENTERPRISES LIMITEDSUCRAFIL O GELSUCRALFATE + OXETACAINE10MG + 0.2MGFOURRTS INDIA LABORATORIES PVT. LIMITED-VANDALUR ROAD, KELAMBAKKAM 603103, CHENNAI, TAMIL NADU, INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE
748NDA/MAL/HDP/1457NABIQASIM INDUSTRIES (PVT) LIMITEDJEET PHARMACEUTICALS LIMITEDDYSEN FORTESECNIDAZOLE1000MGNABIQASIM INDUSTRIES (PVT) LIMITED-17/24, KORANGI INDUSTRIAL AREA, KARACHI, PAKISTANPAKISTANORAL SOLID ORDINARY TABLETS1.0X2.0 TABLET BLISTER
749NDA/MAL/HDP/1459NVS KENYA LTDSURGIPHARM (U) LIMITEDTASIGNA 200NILOTINIB200MGNORVATIS PHARMA STEIN AG-SCHAFF HAUSER STRASSE 4332, STEIN - SWITZERLANDSWITZERLANDORAL SOLID ORDINARY CAPSULES1.0X2.0X14.0 CAPSULE BLISTER
750NDA/MAL/HDP/1460VENUS REMEDIES LIMITEDAARON PHARMACEUTICALS LTDPARIN EENOXAPARIN80MGVENUS REMEDIES LTD --UNIT II HILL TOP INDUSTRIAL ESTATE JHARMAJRI EPIP PHASE I BHATOLI KALAN BADDI (H.P)INDIAPARENTERAL ORDINARY PRE-FILLED SYRINGES1.0X10.0X2.0 ML PRE- FILLED SYRINGE
751NDA/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 BOTTLE
752NDA/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 BLISTER
753NDA/MAL/HDP/1465NORVATIS PHARMA AGSURGIPHARM (U) LIMITEDVOLTFASTDICLOFENAC POTASSIUM50MGMIPHARM S.P.A -VIA BERNARDO QUARANTA, 12-20141, MILANO ITALY.ITALYORAL LIQUID ORDINARY SOLUBLE POWDERS1.0X3.0 SACHET CARTON
754NDA/MAL/HDP/1468CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDOCID CAPSULESOMEPRAZOLE20MGCADILA HEALTHCARE LTD-PLOT 203-213, KUNDAIM INDUSTRIAL ESTATE, GOA, S KANT HEALTHCARE LTD-PLOT NO. 1802-1805, G.I.D.C. PHASE III, VAPI 396 195. GUJARAT.INDIAORAL SOLID RETARD CAPSULES1.0X10.0X10.0 CAPSULE STRIP
755NDA/MAL/HDP/1469VOGEN LABORATORIES LTDBUFFALO HEALTH CARE LTDDURAMOX 125AMOXICILLIN125MG/5MLVOGEN LABORATORIES LTD-70, M.HERACLEOUS STR. AYIOS ATHANASIOS INDUSTRIAL AREA, LIMASSOL, CYPRUSCYPRUSORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE
756NDA/MAL/HDP/1471PT SAMBE FARMAMEDVIN PHARMA LIMITEDTEMIRALACICLOVIR30MG/GPT SANBE FARMA JI INDUSTRI-NO.8 KOMPLEKS INDUSTRI CIMAREME PADALARANG BANDUNGINDONESIAOPHTHALMIC OINTMENTS1.0X3.5 G TUBE
757NDA/MAL/HDP/1472GLAXO WELLCOME (KENYA) LTDERIS LTDFORTUM INJECTIONCEFTAZIDIME1GMGLAXOSMITHKLINE LTD MANUFACTURING SPA-VERONAITALYPARENTERAL ORDINARY VIALS1.0X1.0 G VIAL
758NDA/MAL/HDP/1474AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGODICDICLOFENAC DIETHYLAMINE1%W/WAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIATOPICAL EXTERNAL GELS AND SOLS1.0X30.0 G TUBE
759NDA/MAL/HDP/1476AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDSEPTOLSILVER SULFADIAZINE + CHLORHEXIDINE GLUCONATE1%W/W + 0.20W/WAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIATOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE
760NDA/MAL/HDP/1478AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDKAMAGRASILDENAFIL50MGAJANTA PHARMA LTD .-B-4//5/6, MIDC INDUSTRIALAREA, PAITHAN-431 128, AURANGBADINDIAORAL SOLID ORDINARY TABLETS1.0X1.0X4.0 TABLET BLISTER
761NDA/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 BLISTER
762NDA/MAL/HDP/1482SANOFI PASTEURLABOREX UGANDA LIMITEDSTAMARIL PASTEURYELLOW FEVER VIRUS 17D-204 STRAIN(LIVE ATTENUATED)NLT 1000 I.USANOFI PASTEUR-1541 AVENUE MARCEL MERIEUX, 69280 MARCY, LETOILE,SANOFI PASTEUR S.A-2,AVENUE PONT PASTEUR 69007 LYON-FRANCE(BUSINESS ADDRESS)FRANCEPARENTERAL ORDINARY VIALS1.0X1.0 DOSE VIAL + 0.5ML OF SOLVENT IN PRE-FILLED SYRINGE
763NDA/MAL/HDP/1486ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDAMPIMAX-1AMPICILLIN1GREYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG PROVINCE P.R. 256100CHINAPARENTERAL ORDINARY DRY VIALS1.0X50.0X1.0 G VIAL
764NDA/MAL/HDP/1487BAYER PHARMA AGSURGIPHARM (U) LIMITEDSCHERIPROCT SUPPOSITORIESPREDNISOLONE CAPROATE/ CINCHOCAINE HYDROCHLORIDE1.3MG/ 1MGBAYER HEALTH CARE MANUFACTURING S.R.I -S.P.A VIA SCHERING,21 20090 SEGRATE (MILAN) ITALYITALYRECTAL SYSTEMIC SUPPOSITORIES1.0X12.0 SUPPOSITORY STRIP
765NDA/MAL/HDP/1488ERIS LTDBENLE CONSULT LIMITEDDICLO-DENK 100 RECTALDICLOFENAC SODIUM100MGHAUPT PHARMA WULFING GMBH.-BETHELNER LANDSTR. 18, 31028 GRONAUGERMANYRECTAL SYSTEMIC ADULT SUPPOSITORIES10.0X1.0X2.0X5.0 SUPPOSITORY STRIP,1.0X5.0 SUPPOSITORY STRIP
766NDA/MAL/HDP/1492ERIS LTDBENLE CONSULT LIMITEDDICLO-DENK 75 INJECTIONDICLOFENAC SODIUM25MG/MLHAUPT PHARMA WULFING GMBH;--BETHELNER LANDSTR. 18, 31028 GRONAULLEIRE, GERMANY.GERMANYPARENTERAL ORDINARY AMPOULES1.0X10.0X3.0 ML AMPOULE
767NDA/MAL/HDP/1494FERRER INTERNACIONAL S.ALABOREX UGANDA LIMITEDPEITEL 0.25%PREDNICARBATE0.25%W/WFERRER INTERNACIONAL, S.A-JOAN BUCSALA 1-9, 08173 SANT CUGAT DEL VALLES, BARCELONA, SPAINSPAINTOPICAL EXTERNAL CREAMS1.0X30.0 G TUBE
768NDA/MAL/HDP/1495WOCKHARDT LTDSTAR PHARMACEUTICALS LTDPELOX-400PEFLOXACIN400MGWOCKHARDT LIMITED --PLOT 57 VILLAGE KUNJHAL, JHAMAJRI, BAROTIWALA, BADDI, TEHSIL-NALAGARH, DISTRICT SOLAN, 174103 HIMACHAL PRADESH, INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET STRIP
769NDA/MAL/HDP/1497LABORATORY AND ALLIED LTDHARLEYS UGANDA LIMITEDLAEOVATE CREAMBETAMETHASONE VALERATE0.1%W/WLABORATORY & ALLIED LTD--PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, MOMBASA ROAD P.O. BOX 42875, GPO 00100, NAIROBI, KENYAKENYATOPICAL EXTERNAL CREAMS1.0X1.0X15.0 G TUBE
770NDA/MAL/HDP/1499GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDPROMETHAZINEPROMETHAZINE HYDROCHLORIDE25MG/MLNINGBO DAHONGYING PHARMACEUTICALS LTD- NO. 396 MINCHINAPARENTERAL ORDINARY AMPOULES1.0X2.0 ML AMPOULE
771NDA/MAL/HDP/1500MERCK SHARP & DOHME BVPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDATRIPLAEFAVIRENZ+EMTRICITABINE + TENOFOVIR600MG +200MG+300MGPATHEON INC-MISSISSAUGA,ON L5N 7K9 CANADANETHERLANDSORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET CONTAINER
772NDA/MAL/HDP/1501REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDCURAQUIN SYRUPQUININE HYDROCHLORIDE100MG/5MLREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE
773NDA/MAL/HDP/1503MEDICAL UNION PHARMACUITICALSKARURI PHARMACEUTICALS LTD.SEDIPROCT CREAMHYDROCORTISONE+CINCHOCAINE0.5%W/W + 0.5%W/WMEDICAL UNION PHARMA .CO-ABU-SULTAN ISMAILIA EGYPTEGYPTTOPICAL EXTERNAL OTHER CREAMS1.0X20.0 G TUBE
774NDA/MAL/HDP/1505GLAXOSMITHKLINEERIS LTDSERETIDE EVOHALERSALMETEROL/ FLUTICASONE PROPIONATE25/50 MCGGLAXO WELLCOME PRODUCTION-ZONE INDUSTRIELLE NO.2
23 RUE LAVOISER 27000 EVREUX
FRANCELUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER1.0X1.0 CANNISTER CARTON
775NDA/MAL/HDP/1506WOCKHARDT LTDSTAR PHARMACEUTICALS LTDWEPOX 2000RECOMBINANT HUMAN ERYTHROPOIETIN2000 IUWOCKHARDT LIMITED --WOCKHARDT BIOTECH PARK, H14/2, M.I.D.C, WALUJ, AURANGABAD 431136 MAHARASHTRA INDIAINDIAPARENTERAL ORDINARY PRE-FILLED SYRINGES1.0X0.5 ML PRE- FILLED SYRINGE
776NDA/MAL/HDP/1508DAWA LIMITEDSUPER MEDIC LTDWOMNILALBENDAZOLE200MG/5MLDAWA-PLOT 7879, BABA DOGO ROAD RUARAKA, NAIROBI, KENYAKENYAORAL LIQUID ORDINARY SUSPENSIONS1.0X10.0 ML BOTTLE
777NDA/MAL/HDP/1509BETA HEALTHCARE UGANDA LIMITEDBETA HEALTHCARE UGANDA LIMITEDFEVEREXPARACETAMOL120MG/5MLBETA HEALTHCARE INTERNATIONAL LTD-PLOT LR 209/6554 MOGADISHU ROAD, OFF LUNGA LUNGA ROAD, INDUSTRIAL AREA NAIROBI, 00100,KENYAORAL LIQUID ORDINARY SUSPENSIONS1.0X60.0 ML BOTTLE
778NDA/MAL/HDP/1510JOHNSON &JOHNSON (PTY) LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDLISTERINE ANTISEPTICTHYMOL + ALCOHOL 95%12.78MG/20ML + 5.60ML/MLJOHNSON&JOHNSON PTY LTD.-EDMS BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICASOUTH AFRICAORAL LIQUID ORDINARY LIQUIDS1.0X500.0 ML BOTTLE,1.0X250.0 ML BOTTLE
779NDA/MAL/HDP/1513ANKUR DRUGS AND PHARMA LTDJOINT MEDICAL STORE (UPMB - UCMB)VEXACEFCEFTRIAXONE1GANKUR DRUGS AND PHARMA LTD-WHITE TO OFF WHITE VILLAGE – MANAKPUR, PO – LODHIMAJRA, NELAGARH DIST.INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0 G VIAL
780NDA/MAL/HDP/1514JOHNSON&JOHNSON PTY LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDVERMOXMEBENDAZOLE100MGSPECPHARM HOLDINGS- 15TH ROAD HALFWAY HOUSESOUTH AFRICAORAL SOLID ORDINARY CHEWABLE TABLETS1.0X6.0 TABLET BLISTER
781NDA/MAL/HDP/1516WIN-MEDICARE LTDSURGIPHARM (U) LIMITEDURGENDOL PTRAMADOL/ PARACETAMOL37.5MG/ 325MGWIN MEDICARE PVT LIMITED-MEERUT, MUZAFFARNAGER ROAD, MODIPURAM – 250110, UTTAR
PRADESH - INDIA
INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER
782NDA/MAL/HDP/1517NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDVEST MENTAMU BALMCOMPOUND METHYLSALICYLATEMULTI INGREDIENTNEM LABORATORIES PVT LTD-133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAIINDIATOPICAL EXTERNAL OINTMENTS1.0X15.0 G TUBE
783NDA/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 382210INDIALUNG ADMINISTRATION METERED-DOSE INHALER1.0X1.0 CANNISTER CARTON
784NDA/MAL/HDP/1522GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDPENAMOXAMOXYCILLIN250MGMEDREICH STERILAB LTD-12TH MILE, OLD MADRAS ROAD, VIRGONAGOR, BANGALORE 560049, INDIAINDIAORAL SOLID ORDINARY CAPSULES10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER
785NDA/MAL/HDP/1523RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDAMPIRENAMPICILLIN125MG/5MLRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKAUGANDAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE
786NDA/MAL/HDP/1524RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDAMOXIRENAMOXICILLIN TRIHYDRATE125 MG / 5 MLRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKAUGANDAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE
787NDA/MAL/HDP/1525CIPLA LTDQUALITY CHEMICALS LTD - HUMANBENDEXALBENDAZOLE20MG/5MLCIPLA LTD-VERNA INDUSTRIAL ESTATE, GOAINDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X10.0 ML BOTTLE
788NDA/MAL/HDP/1526FERRER INTERNACIONAL S.ALABOREX UGANDA LIMITEDGAMALATE B6MAGNESIUM GLUTAMATE HYDROBROMIDE + AMINOBUTYRIC ACID + AMINO HYDROXYBUTYRIC ACID + VITAMIN B675MG + 75MG + 37MG + 37MGFERRER INTERNACIONAL S.A --FOR LABORATORIOS NOVAG S.A GRAN VIA CARLOS III 94 08028 BARCELONASPAINORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER
789NDA/MAL/HDP/1527MICRO LABS LTDLABOREX UGANDA LIMITEDBACTOCLAVAMOXICILLIN + CLAVULANATE POTASSIUM200MG + 28.5MG/ 5MLMICRO LABS LIMITED.-PLOT 16, VEERASANDRA IND. AREA,ANEKAL TALUK, BANGALORE INDIAINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X1.0X100.0 ML BOTTLE
790NDA/MAL/HDP/1528MICRO LABS LTDLABOREX UGANDA LIMITEDBACTOCLAV-625AMOXYCILLIN + CLAVULANATE POTASSIUM500 MG + 125 MGMICRO LABS LIMITED -PLOT 16 VEERASANDRA IND. AREA,ANEKAL TALUK,BANGALORE INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X1.0X6.0 TABLET BLISTER,1.0X2.0X10.0 TABLET BLISTER
791NDA/MAL/HDP/1529BAYER PHARMA AGSURGIPHARM (U) LIMITEDPROVIRONMESTEROLONE25MGBAYER WEIMAR GMBH & CO. KG-DOBEREINERSTRASSE 20 D-99427 WEIMAR, GERMANYGERMANYORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER
792NDA/MAL/HDP/1531CIPLA LTDQUALITY CHEMICALS LTD - HUMANNOVATAXCEFOTAXIME1GMMEDISPRAY LABORATORIES PVT LTD --L-1/1, L-1/2/2, ADDITIONAL MIDC SATARA 415004INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0 G VIAL
793NDA/MAL/HDP/1533OTSUKA PHARMACEUTICAL INDIA PRIVATE LIMITEDREDDYS PHARMA LIMITED5DGLUCOSE50G/LOTSUKA PHARMACEUTICAL INDIA PRIVATE LTD-VILLAGE – VASANA – CHACHARWADIP, TAL: SANAND, AHMADABADINDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X500.0 ML BOTTLE,1.0X250.0 ML BOTTLE
794NDA/MAL/HDP/1534BEIJING HOLLEY COTEC PHARMA CHINASUPER PHARMACEUTICALS LIMITEDPARACETAMOLPARACETAMOL500MGSHANDONG XIER KANGTAI PHARMACEUTICAL CO LTD-YANZHOU CITY, CHINACHINAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER
795NDA/MAL/HDP/1535ABACUS PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDFORTIWIN-4FORTIFIED PROCAINE PENICILLIN SODIUM4 M.UREYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG PROVINCE P.R. 256100CHINAPARENTERAL ORDINARY DRY VIALS1.0X50.0X4.0 MU VIAL
796NDA/MAL/HDP/1537ELYS CHEMICAL INDUSTRIES LTDVELVET PHARMA LIMITEDELYZOLEALBENDAZOLE200MGELYS CHEMICAL INDUSTRIES LIMITED-ROAD B’, OFF ENTERPRISE ROAD
PLOT NO. 209/8927 INDUSTRIAL AREA
KENYAORAL SOLID ORDINARY TABLETS1.0X20.0X2.0 TABLET BLISTER
797NDA/MAL/HDP/1538ELYS CHEMICAL INDUSTRIES LTDVELVET PHARMA LIMITEDELYZOLE SUSPENSIONALBENDAZOLE200MGELYS CHEMICAL INDUSTRIES LIMITED-ROAD B’, OFF ENTERPRISE ROAD
PLOT NO. 209/8927 INDUSTRIAL AREA
KENYAORAL LIQUID ORDINARY SUSPENSIONS1.0X10.0 ML BOTTLE
798NDA/MAL/HDP/1539KWALITY AFRO ASIA LIMITEDKWALITY AFRO ASIA LIMITEDK-TRIMSULFAMETHOXAZOLE + TRIMETHOPRIM200MG + 40MGKWALITY AFRO-ASIA LTD-PLOT 165 KAWEMPE BOMBO ROADUGANDAORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE
799NDA/MAL/HDP/1544AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDPROMETHAZINE HYDROCHLORIDE B.PPROMETHAZINE HCL25MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
800NDA/MAL/HDP/1546UNICHEM LABORATORIES LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDLANPROLANSOPRAZOLE30MGUNICHEM LABORATORIES LTD--PLOT 17 & 18, PILERNE IND. ESTATE, PILERNE, BARDEZ GOA-403511INDIAORAL SOLID ORDINARY CAPSULES1.0X5.0X2.0X10.0 CAPSULE BLISTER
801NDA/MAL/HDP/1547MYLAN LABORATORIES LIMITED.NORVIK ENTERPRISES LIMITEDLUSIA-FNORGESTREL/ ETHINYL ESTRADIOL + FERROUS FUMARATE0.3MG/ 0.03MG + 75MGMYLAN LABORATORIES LIMITED.--PLOT NO. 1606-1609, SARIGAM INDUSTRIAL AREA, GIDC, SARIGAM, TAL-UMERGAM, DIST VALSAD, 396155, GUJARAT, INDIA.,MYLAN LABORATORIES LIMITED..-PLOT NO.20 & 21, PHARMEZ, SARKHEJ-BAVLA NATIONAL HIGHWAY NO. 08A, NEAR VILLAGE MATODA, TAL-SANAND, AHMEDABAD, GUJARAT, INDIA 382213INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X28.0 TABLET BLISTER
802NDA/MAL/HDP/1550GALENTIC PHARMA( INDIA)PVT LTDNORVIK ENTERPRISES LIMITEDRUBIGELMULTI-INGREDIENTMULTI-INGREDIENTGALENTIC PHARMA PVT. LIMITED -R-673, TTC MIDC, RUBALE, THANE BELAPUR NAVI MUMBAI 400 701
INDIA
INDIAORAL TOPICAL GELS AND SOLS1.0X30.0 G TUBE
803NDA/MAL/HDP/1551EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDCALOSHELL-500CALCIUM CARBONATE + VITAMIN D31250MG + 250IUEMCURE PHARMACEUTICALS LTD-LANE NO.3 PHASE II SIDCO INDUSTRIAL COMPLEX BARI BRAHMANA JAMMU (J&K) 18113INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER
804NDA/MAL/HDP/1553EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDVIFEXSALBUTAMOL + BROMHEXINE + GUAIFENESIN1MG/5ML+2MG/5ML+50MG/5MLEMCURE PHARMACEUTICALS LTD-LANE NO.3 PHASE II SIDCO INDUSTRIAL COMPLEX BARI BRAHMANA JAMMU (J&K) 18113INDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE
805NDA/MAL/HDP/1555GALENTIC PHARMA( INDIA)PVT LTDNORVIK ENTERPRISES LIMITEDGALSCRUBCHLORHEXIDINE4%W/WGALENTIC PHARMA PVT. LIMITED -R-673, TTC MIDC, RUBALE, THANE BELAPUR NAVI MUMBAI 400 701
INDIA
INDIATOPICAL EXTERNAL LIQUIDS1.0X500.0 ML BOTTLE
806NDA/MAL/HDP/1556VIRBAC RSA (PTY) LTDMETRO PHARMACEUTICALS LIMITEDDOMI UPONDASENTRON2MG/MLLINCOLN PARENTERAL LTD-11, TRIMUL ESTATE, NEAR KHATRAJ CHOLADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARATINDIAPARENTERAL ORDINARY AMPOULES1.0X10.0X2.0 ML AMPOULE
807NDA/MAL/HDP/1557GLAXOSMITHKLINEERIS LTDSYNFLORIX VACCINEPNEUMOCOCCAL POLYSACCHARIDE SEROTYPES (1,5,6B,7F,9V,14,23F) + (4,18C,19F) + PROTEIN D+TETANUS TOXOID+DIPTHERIA TOXOID CARRIER PROTEINS AND ALUMINIUM PHOSPHATE1MCG+3MCG+13MCG+8MCG+5MCG+0.5MGGLAXOSMITHKLINE BOILOGICALS-S.A RUE DE I'INSTITUT 89 B-1330 RIXENSARTBELGIUMPARENTERAL ORDINARY PRE-FILLED SYRINGES1.0X0.5 ML PRE- FILLED SYRINGE (1 DOSE),1.0X100.0X0.5 ML VIAL (1 DOSE)
808NDA/MAL/HDP/1558PFIZER LABORATORIES (PTY) LTDLABOREX UGANDA LIMITEDGABBRORALAMINOSIDINE SULPHATE250MGPHARMACIA AND UPJOHN S.P.A-RIJKSWEG 12, B-2870 PUURSBELGIUMORAL SOLID ORDINARY TABLETS1.0X12.0 TABLET STRIP
809NDA/MAL/HDP/1559LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDDOLOMOLPARACETAMOL500MGLINCOLN PHARMACEUTICALS LTD-10, 11, 13, TRIMUL ESTATE KHATRAJ, NEAR KHATRAJ, CHOKADI , KHATRAJ-382721, GHANDINAGAR GUJARAT, INDIA
INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X1.0X10.0 TABLET BLISTER
810NDA/MAL/HDP/1563GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDAMOXILAMOXYCILLIN125MG/5MLGLAXO WELLCOME PRODUCTION.-ZONE INDUSTRIELLE DE LA PEYENNIERE 53100 MAYENNE, FRANCEFRANCEORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE
811NDA/MAL/HDP/1566AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDVITAVITMULTI-INGREDIENTMULTI-INGREDIENTAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY OTHER COATED TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
812NDA/MAL/HDP/1568: ALKEM LABORATORIES LIMITED?ABACUS PHARMA (AFRICA) LIMITEDCLAVAMAMOXICILLIN AND CLAVULANATE POTASSIUM156.25MGALKEM LABORATORIES LTD-PLOT 167/1 VILLABE DAHBEL AMALIYA DAMAN 396210INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE
813NDA/MAL/HDP/1570KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAM AMOXYAMOXYCILLIN125MG/5MLKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALAUGANDAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE
814NDA/MAL/HDP/1571BHARAT SERUMS AND VACCINES LTDGITTOES PHARMACEUTICALS 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)
815NDA/MAL/HDP/1574INTAS, PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDAMTAS-5AMLODIPINE5MGINTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIAINDIAORAL SOLID ORDINARY TABLETS2.0X2.0X7.0 TABLET BLISTER,10.0X10.0 TABLET BLISTER
816NDA/MAL/HDP/1575ASTRAZENECAMACNAUGHTON LIMITEDZESTRILLISINOPRIL20MGASTRAZENECA PHARMACEUTICALS LP -HUANGSHAN ROAD, WUXI 214028, JIANGSU, CHINA.,ASTRAZENECA MACCLESFIELD-CHESHIREUNITED KINGDOMORAL SOLID ORDINARY TABLETS1.0X2.0X14.0 TABLET BLISTER
817NDA/MAL/HDP/1576ASTRAZENECAMACNAUGHTON LIMITEDZESTRILLISINOPRIL10MGASTRAZENECA PHARMACEUTICALS LP -HUANGSHAN ROAD, WUXI 214028, JIANGSU, CHINA.,ASTRAZENECA MACCLESFIELD-UNITED KINGDOMUNITED KINGDOMORAL SOLID ORDINARY TABLETS1.0X1.0X14.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER
818NDA/MAL/HDP/1579PT SANBE FARMAMEDVIN PHARMA LIMITEDPLASMINEXTRANEXAMIC ACID100MG/MLPT SANBE FARMA JI INDUSTRI-NO.8 KOMPLEKS INDUSTRI CIMAREME PADALARANG BANDUNGINDONESIAPARENTERAL ORDINARY AMPOULES1.0X10.0X5.0 ML AMPOULE
819NDA/MAL/HDP/1581MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDPANTOTABPANTOPRAZOLE40MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIAINDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER
820NDA/MAL/HDP/1582LINCON PHARMCUETICALS LIMITEDMETRO PHARMACEUTICALS LIMITEDCEEPRO-500CIPROFLOXACIN500MGLINCOLN PHARMACEUTICALS LTD--TRIMUL ESTATE AFER VODSAR VILLAGE KHATJAT 382 721 GUJARAT VADSAR P.O.J TALUKA KALOH DIST GANDHINAGAR INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER
821NDA/MAL/HDP/1583INDOCO REMEDIES LIMITEDTATA UGANDA LIMITEDABZEEALBENDAZOLE200MG/5MLINDOCO REMEDIES LTD-B-20, MIDC, WALUJ, AURANGABAB 431136 INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X10.0 ML BOTTLE
822NDA/MAL/HDP/1584UNI MEDICO LABSHREEJI PHARMACEUTICALS LIMITEDUCLOXCLOXACILLIN SODIUM500MGUNI MEDICOLABS.- 21-22 PHARMACITY SELAQUI DEHRADUN 248197INDIAPARENTERAL ORDINARY DRY VIALS1.0X500.0 MG VIAL
823NDA/MAL/HDP/1585WIN-MEDICARE PVT LTDSURGIPHARM (U) LIMITEDUDIHEP FORTEURSODEOXYCHOLIC ACID300MGWIN-MEDICARE PRIVATE LIMITED-MEERUT-MUZAFFARNAGAR ROAD, MODIPURAM - 250110 UTTAR PRADESHINDIAORAL SOLID ORDINARY TABLETS1.0X5.0X10.0 TABLET BLISTER
824NDA/MAL/HDP/1588TORRENT PHARAMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.TOZAAR-HLOSARTAN POTASSIUM + HYDROCHLOROTHIAZIDE50MG + 12.5MGTORRENT PHARMACEUTICALS LIMITED -AHMEDABAD-MEHSANA HIGHWAY, TAL. KADI, DIST. MEHSANA, INDRAD 382 721, GUJARATINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET STRIP,1.0X4.0X7.0 TABLET BLISTER
825NDA/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 BOTTLE
826NDA/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 BOTTLE
827NDA/MAL/HDP/1598AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOCIM 400CIMETIDINE400MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER
828NDA/MAL/HDP/1605RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDASPIRIN TABLETSACETYL SALICYLIC ACID300MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL SOLID ORDINARY TABLETS1.0X500.0 TABLET CONTAINER
829NDA/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 BLISTER
830NDA/MAL/HDP/1615AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDAPCALIS SXTADALAFIL20MGAJANTA PHARMA LTD .-B-4//5/6, MIDC INDUSTRIALAREA, PAITHAN-431 128, AURANGBADINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X2.0 TABLET BLISTER
831NDA/MAL/HDP/1616AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDCEZINCETIRIZINE5MG/5MLAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE,1.0X30.0 ML BOTTLE,1.0X60.0 ML BOTTLE
832NDA/MAL/HDP/1620IRAN MEDICAL GROUP COMPANYUNEED GLOBAL GROUP LIMITEDLORAXONECEFTRIAXONE1000MGEXIR PHARMACEUTICAL FACTORY-2ND KM, BORUJERD, RUIRANPARENTERAL ORDINARY DRY VIALS1.0X1000.0 MG VIAL
833NDA/MAL/HDP/1627GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDCANDID-V GELCLOTRIMAZOLE2%W/WGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,DINDIAVAGINAL GELS AND SOLS1.0X30.0 G TUBE
834NDA/MAL/HDP/1629INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDCARVETAS 12.5CARVEDILOL12.5MGINTAS PHARMACEUTICALS LTD-SELAQUI DEHRADUN 248197INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER
835NDA/MAL/HDP/1631AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDNEVIRAPINE ORAL SUSPENSIONNEVIRAPINE50MG/5MLAUROBINDO PHARMA LTD-UNIT III SURVEY NO 313& 314, BACHUPALLY (V),QUTHUBULLAPUR (M), RANGA REDDY (DIST) TELANGANA STATE,INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X240.0 ML BOTTLE,1.0X100.0 ML BOTTLE
836NDA/MAL/HDP/1632: ALKEM LABORATORIES LIMITED?ABACUS PHARMA (AFRICA) LIMITEDCLAVAM 1.2GAMOXICILLIN SODIUM + CLAVULANATE POTASSIUM1000MG +200MGALKEMS LABORATORIES LIMITED-PLOT 167/1 MAHATMA GHANDHI, UDYOG NAGAR, DABHEL, AMALIYA DAMAN- 396 210
UTTARANCHAL, INDIA.
INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0 VIAL CARTON
837NDA/MAL/HDP/1635CADILA PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.ORITAXIM 1000MG INJECTIONCEFOTAXIME SODIUM1GMCADILA PHARMACEUTICALS LTD.-1389, TRASAD ROAD, DHOLKA 387810 DISTRICT AHMEDABAD GUJARAT STATEINDIAPARENTERAL ORDINARY VIALS1.0X1.0 G VIAL
838NDA/MAL/HDP/1636NORVATIS PHARMA AG- SWITZERLANDLABOREX UGANDA LIMITEDVIGAMOXMOXIFLOXACIN5MG/MLS.A.ALCON COUVREUR N.V-RIJKSWEG 14, B-2870 PUURS BELGIUMBELGIUMOPHTHALMIC DROPS1.0X5.0 ML BOTTLE
839NDA/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 BLISTER
840NDA/MAL/HDP/1639GLAXO SMITHLINE LIMITEDUNITED HEALTHCARE DISTRIBUTORS LTDPANADOL EXTRAPARACETAMOL + CAFFEINE500MG + 65MGGLAXOSMITHKLINE LIMITED - -78392-00507, VIWANDANI LIKONI ROAD NAIROBI KENYAKENYAORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CARTON
841NDA/MAL/HDP/1641UNICHEM LABORATORIES LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDUNIENZYME C MPSNICOTINAMIDE+SIMETHICONE+PAPAIN+FUNGAL DIASTASE+CHARCOAL25MG+50MG+30MG+20MG+75MGUNICHEM LABORATORIES LTD---C31 & 32 INDUSTRIAL AREAINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET STRIP
842NDA/MAL/HDP/1645ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDASTAZOLEMEBENDAZOLE100MGASTRA LIFE CARE (INDIA) PVT.LTD-PLOT 57/P, RAJODA-382220, BAVLA AHMEDABAD, INDIAINDIAORAL SOLID ORDINARY CHEWABLE TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
843NDA/MAL/HDP/1646BETA HEALTHCARE INTERNATIONAL LTDBETA HEALTHCARE UGANDA LIMITEDBETROZOLE TABLETSMETRONIDAZOLE+DILOXANIDE200MG+250MGBETA HEALTHCARE INTERNATIONAL LTD - -PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYAKENYAORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET BLISTER
844NDA/MAL/HDP/1650NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDTEGRETOL CR 200CARBAMAZEPINE200MGNOVARTIS FARMA S.P.A.-VIA PROVINCIALE SCHITO 131, 80058 TORRE ANNUNZIATA, ITALYITALYORAL SOLID RETARD TABLETS1.0X5.0X10.0 TABLET BLISTER
845NDA/MAL/HDP/1651FOURTS(INDIA) LABORATORIES PVT LTDDELMAW ENTERPRISES LIMITEDMEGATRIM SUSPENSIONCO-TRIMOXAZOLE240MG/5MLFOURTS (INDIA) LABORATORIES PRIVATE LIMITED -VANDALUR ROADINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE
846NDA/MAL/HDP/1660AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOCIM-200CIMEDITINE200MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET STRIP
847NDA/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 CONTAINER
848NDA/MAL/HDP/1663MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDALCID-PINKALUMINIUM HYDROXIDE/MAGNESIUM TRISILICATE400MG+400MG/50MLTORQUE PHARMACEUTICALS PVT LTD-ISAAPUR P.O DAPPAR 140056 INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X400.0 ML BOTTLE,1.0X160.0 ML BOTTLE
849NDA/MAL/HDP/1665AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOXIN CAPSULESAMOXICILLIN TRIHYDRATE250MGMILAN LABORATORIES (INDIA ) PVT LTD-PLOT NO 63/67/87 J.C.I.E LTD KAMOTHE PANVER, NAVI MUMBAI,INDIAINDIAORAL SOLID ORDINARY CAPSULES1.0X100.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER
850NDA/MAL/HDP/1666SANOFI AVENTISLABOREX UGANDA LIMITEDAMARYL 1GLIMEPIRIDE1MGSANOFI AVENTIS-2 BOND STREET MIDRAND 1685 SOUTH AFRICASOUTH AFRICAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER
851NDA/MAL/HDP/1669SANOFI AVENTISLABOREX UGANDA LIMITEDAMARYL 2GLIMEPIRIDE2MGAVENTIS PHARMA-AVENTIS PHARMA, 315 WALTLOO ROAD, SILVERTON 0127 PRETORIASOUTH AFRICAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER
852NDA/MAL/HDP/1670SANOFI AVENTISLABOREX UGANDA LIMITEDAMARYL 4GLIMIPIRIDE4MGAVENTIS PHARMA-AVENTIS PHARMA, 315 WALTLOO ROAD, SILVERTON 0127 PRETORIASOUTH AFRICAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER
853NDA/MAL/HDP/1673GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDAMOXILAMOXYCILLIN250MGGLAXO WELLCOME PRODUCTION -Z.I DE LA PEYENNIERE 53100 MAYENNE FRANCEFRANCEORAL SOLID ORDINARY CAPSULES10.0X10.0 CAPSULE BLISTER
854NDA/MAL/HDP/1675MERCK SHARP & DOHME BVPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDGARDASILQUADRIVALENT HUMAN PAPILLOMAVIRUS RECOMBINANT VACCINE (TYPES 6, 11, 16, 18)(20MCG+40MCG+40MCG+20MCG)/0.5MLMERK & CO. INC-SUMNEYTOWN PIKE, P.O BOX 4, WEST POINT, PENNSYLVANIA, U.S. 19486, USAUNITED STATESPARENTERAL ORDINARY PRE-FILLED SYRINGES1.0X0.5 ML PRE- FILLED SYRINGE (1 DOSE),1.0X10.0X0.5 ML VIAL (1 DOSE)
855NDA/MAL/HDP/1676KOPRAN LIMITEDTATA UGANDA LIMITEDCLOXIN-250CLOXACILLIN250MGKOPRAN LTD-VILLAGE SAVROLI TAL KHARAPUR DIST RAIGAD 410 202INDIAORAL SOLID ORDINARY CAPSULES1.0X100.0 CAPSULE CONTAINER,1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER
856NDA/MAL/HDP/1677MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDZIDOVUDINEZIDOVUDINE300MGMACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X60.0 TABLET BOTTLE
857NDA/MAL/HDP/1678ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDHYDROCORTISONE SODIUM SUCCINATEHYDROCORTISONE SODIUM SUCCINATE100MG/VIALZHEJIANG RUIXIN PHARMACEUTICAL CO. LTD-KAIFA ROAD, LISHUI, ZHEJIANG P.R OF CHINACHINAPARENTERAL ORDINARY DRY VIALS1.0X10.0X100.0 MG VIAL
858NDA/MAL/HDP/1679LEBEN LABORATORIES PVT. LTDANDYCO PHARMACY (UGANDA) LTDCIPROLEBCIPROFLOXACIN500MGLEBEN LABORATORIES PVT. LTD.-PLOT NO. L-4, PHASE –III, M.I.D.C, AKOLA, 444104, MAHARASHTRA, INDIA.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER
859NDA/MAL/HDP/1680NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDH-CORTHYDROCORTISONE0.1%W/WNEM LABORATORIES PVT LTD-133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAIINDIATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE
860NDA/MAL/HDP/1681CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDLOSACAR 25LOSARTAN POTASSIUM25MGCADILA HEALTH CARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X7.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER
861NDA/MAL/HDP/1682VIRBAC RSA (PTY) LTDMETRO PHARMACEUTICALS LIMITEDTOFLOX-200OFLOXACIN200MGLINCOLN PHARMACEUTICAL LIMITED-TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER,1.0X10.0X1.0X10.0 TABLET BLISTER
862NDA/MAL/HDP/1683Y.S.P INDUSTRIES (M) SDN BHDROYAL PHARMA 2011 LIMITEDVOREN PLUSDICLOFENAC10MG/ML Y.S.P INDUSTRIES (M) SDN BDH - LOT 3,5 & 7 P/7 SECTION 13 KAWASAN PERINDUSTRIAN BANDAR BARU BANGI 43000 KAJANG SELANGOR DARUL EHSANMALAYSIATOPICAL EXTERNAL GELS AND SOLS1.0X20.0 G TUBE,1.0X45.0 G TUBE
863NDA/MAL/HDP/1684LINCOLN PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDIBUN-200IBUPROFEN200MGLINCOLN PHARMACEUTICALS LTD-10, 11, 13, TRIMUL ESTATE KHATRAJ, NEAR KHATRAJ, CHOKADI , KHATRAJ-382721, GHANDINAGAR GUJARAT, INDIA
INDIAORAL SOLID ORDINARY COATED TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER
864NDA/MAL/HDP/1687LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDALLDOXDOXYCYLINE100MGLINCOLN PHARMACEUTICALS LIMITED-10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER
865NDA/MAL/HDP/1690PHARMA INTERNATIONAL COOMAB UGANDA LIMITEDFINALLERGCETIRIZINE DIHYDROCHLORIDE1MG/MLPHARMA INTERNATIONAL COMPANY-MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDANJORDANORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE
866NDA/MAL/HDP/1691WIDE SPECTRUM ENTERPRISES (U) LIMITEDWIDE SPECTRUM ENTERPRISES (U) LIMITEDZITHRORIVAZITHROMYCIN500MGRIVA PHARMA FREE ZONE-NASR CITY CAIRO EGYPTEGYPTORAL SOLID ORDINARY CAPSULES1.0X3.0 CAPSULE BLISTER
867NDA/MAL/HDP/1692PHARMA INTERNATIONAL COOMAB UGANDA LIMITEDCEFODOX 50MG/5ML SUSPENSIONCEFPODOXIME PROXETIL50MG/5MLPHARMA INTERNATIONAL CO.,-AL-QASTAL AREA, AIRPORT ROAD, 11941, AMMANJORDANORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X50.0 ML BOTTLE
868NDA/MAL/HDP/1693PHARMA INTERNATIONAL COMPANYOMAB UGANDA LIMITEDOPTIMAL (0.05%) CREAMTRETINOIN USP0.5MG/1GPHARMA INTERNATIONAL COMPANY .-MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDANJORDANTOPICAL EXTERNAL CREAMS1.0X1.0X30.0 G TUBE
869NDA/MAL/HDP/1694GLAXO WELLCOME(KENYA),LTDERIS LTDBETNOVATE CREAMBETAMETHASONE VALERATE0.1%W/WGLAXOSMITHKLINE HARMIRE -GLAXOSMITHKLINE HARMIRE ROAD BARNARD CASTLE DURHAMUNITED KINGDOMTOPICAL EXTERNAL CREAMS1.0X30.0 G TUBE,1.0X15.0 G TUBE
870NDA/MAL/HDP/1697PHARMA INTERNATIONAL COOMAB UGANDA LIMITEDFINALLERGCETIRIZINE DIHYDROCHLORIDE10MGPHARMA INTERNATIONAL COMPANY-MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDANJORDANORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER
871NDA/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 BLISTER
872NDA/MAL/HDP/1701KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDFORMINMETFORMIN HYDROCHLORIDE500MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALAUGANDAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER
873NDA/MAL/HDP/1702PHARMA INTERNATIONAL COMPANYOMAB UGANDA LIMITEDDELORCLOBETASOL PROPIONATE0.05%W/WPHARMA INTERNATIONAL COMPANY-MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDANJORDANTOPICAL EXTERNAL OINTMENTS1.0X25.0 G TUBE
874NDA/MAL/HDP/1704DAFRA PHARMA LTDLABOREX UGANDA LIMITEDDAFRACLAVAMOXYCILLIN + POTASSIUM CLAVULANATE500MG + 125MGBILIM PHARMACEUTICALS--CERKEZKOY PLANT, 59500 CERKEZKOY, TEKIRDAGTURKEYORAL SOLID ORDINARY TABLETS1.0X3.0X5.0 TABLET BLISTER
875NDA/MAL/HDP/1707XEPA SOUL PATTISON (M) SDN BHDDELMAW ENTERPRISES LIMITEDFEBRICOL TABLETSPARACETAMOL / PSEUDOEPHEDRINE / CHLORPHENIRAMINE500MG / 30MG /2MGXEPA-SOUL PATTINSON (MALAYSIA) SDN BLD -1-5 CHENG INDUSTRIAL ESTATE, 75250
MALEKA, MALAYSIA
MALAYSIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X2.0X10.0 TABLET BLISTER
876NDA/MAL/HDP/1708LABORATORY AND ALLIED LTDHARLEYS UGANDA LIMITEDDENTAMOLACETAMINOPHEN500MGLABORATORY & ALLIED LTD-PLOT NO. 209/10349
OFF MOMBASA ROAD, NAIROBI
P.O. BOX 42875, NAIROBI, KENYA.
KENYAORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER
877NDA/MAL/HDP/1709REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDLUCIN CREAMHYDROCORTISONE1%W/WREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYATOPICAL EXTERNAL CREAMS1.0X10.0 G TUBE,1.0X15.0 G TUBE,1.0X5.0 G TUBE
878NDA/MAL/HDP/1711KOPRAN LIMITEDTATA UGANDA LIMITEDAMYN-250AMOXYCILLIN250MGKOPRAN LIMITED-VILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIAINDIAORAL SOLID ORDINARY CAPSULES10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER
879NDA/MAL/HDP/1712I CARE PHARMA LIMITEDVITACARE LTDAMPICILLIN SODIUMAMPICILLIN SODIUM500MGREYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100CHINAPARENTERAL ORDINARY DRY VIALS1.0X10.0 VIAL CARTON
880NDA/MAL/HDP/1713MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDLUMITERARTEMETHER + LUMEFANTRINE20 MG + 120 MGMACLEODS PHARMACEUTICALS LTD -PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT), INDIA.,OXALIS LABS -VILLAGE THEDA P.O LODHIMAJRA, THESIL BADDI DISTRICT SOLAN HIMACHAL PRADESH INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X8.0 TABLET BLISTER,1.0X1.0X6.0 TABLET BLISTER,1.0X1.0X24.0 TABLET BLISTER,1.0X30.0X12.0 TABLET BLISTER,1.0X1.0X12.0 TABLET BLISTER,1.0X30.0X18.0 TABLET BLISTER,1.0X1.0X18.0 TABLET BLISTER,1.0X30.0X6.0 TABLET BLISTER,1.0X30.0X24.0 TABLET BLISTER
881NDA/MAL/HDP/1715SHELYS PHARMACEUTICALS LTDBETA HEALTHCARE UGANDA LIMITEDMUCOLYN SYRUPAMMONIUM CHLORIDE+CHLORPHENIRAMINE+DEXTROMETHORPHAN+BROMHEXINE50MG+2MG+5MG+4MGBETA HEALTHCARE INTERNATIONAL LTD - -PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYA,SHELYS PHARMACEUTICALS LTD,-NEW BAGAMOYO ROAD, MWENGE, PLOT NO 696,BLOCK NO 32, P.O.BOX 3016, DAR ES SALAAMTANZANIAORAL LIQUID ORDINARY SYRUPS1.0X1.0X100.0 ML BOTTLE
882NDA/MAL/HDP/1723ABACUS PHARMA (AFRICA) LIMITEDABACUS PHARMA (AFRICA) LIMITEDGROVIT MULTIVITAMINMULTI-INGREDIENTMULTI-INGREDIENTSAKAR HEALTHCARE PVT LTD-SAKAR HEALTHCARE PVT LTD, BLOCK NO 10-13, M.N. DESAINDIAORAL LIQUID ORDINARY DROPS1.0X15.0 ML BOTTLE
883NDA/MAL/HDP/1724GLAXOSMITHKLINE LTDERIS LTDAVAMYS NASAL SPRAYFLUTICASONE FUROATE27.5MCG/ACTUATIONGLAXO OPERATIONS UK LTD---HARMIRE ROAD, BARNARD CASTLE, DURHAM DL128 DT UKUNITED KINGDOMNASAL TOPICAL SPRAYS WITHOUT GAS1.0X120.0 METERED DOSE CANNISTER
884NDA/MAL/HDP/1725REMEDICA LTDGOODMAN INTERNATIONAL LTDMYCORIL CREAM 1%CLOTRIMAZOLE1%W/WREMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHARCYPRUSTOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE
885NDA/MAL/HDP/1726GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDHAVRIX 720INACTIVATED HEPATITIS A VIRUS ADSORBED ON ALUMINIUM HYDROXIDE HYDRATED720 ELISA UNITS ADSORBED ON 0.25MG ALUMINIUM HYDROXIDESMITHKLINE BEECHAM BIOLOGICALS , BELGIUM- BELGIUMBELGIUMPARENTERAL ORDINARY VIALS1.0X0.5 ML VIAL (1 DOSE)
886NDA/MAL/HDP/1727MISSION PHARMAJOINT MEDICAL STORE (UPMB - UCMB)TETRACYCLINE HYDROCLORIDETETRACYCLINE HYDROCHLORIDE3%W/WNANJING BAIJINGYN PHARMACEUTICALS CO.LTD NO-1 HUIZHONG ROAD NANJING ECONOMIC AND TECHNICAL DEVELOPMENT ZONECHINATOPICAL EXTERNAL OINTMENTS1.0X15.0 G TUBE
887NDA/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 STRIP
888NDA/MAL/HDP/1730COSMOS LTDASTRA PHARMA (U) LIMITEDZITHROXAZITHROMYCIN500MGCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBIKENYAORAL SOLID ORDINARY TABLETS1.0X3.0 TABLET BLISTER
889NDA/MAL/HDP/1731REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDMEDIVEN-S OINTMENTBETAMETHASONE VALERATE + SALICYLIC ACID0.05%W/W + 3%W/WREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYATOPICAL EXTERNAL OINTMENTS1.0X15.0 G TUBE
890NDA/MAL/HDP/1732MICRO LABS LTDLABOREX UGANDA LIMITEDCEFEX-250CEPHALEXIN250MGMICROLABS LIMITED-PLOT NO. 121-124, KIADB, BOMMASANDRA , -JIGNI LINK ROAD, ANEKUL TALUK,BANGALORE, KARNATAKA, INDIAINDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER
891NDA/MAL/HDP/1734KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMOMINTCOMPOUND MAGNESIUM TRISILICATE500MGTIL HEALTH CARE-PLOT 100,WEST,R-5,SOUTH;SRICITY SEZ,CHERIVI,IRUHULAM,PSOT,SATYAVEDU MANDAL,CHITOOR DISTRICT-ANDRA PRADESH-517588, INDIAINDIAORAL SOLID ORDINARY CHEWABLE TABLETS10.0 TABLET CONTAINER,250.0 TABLET CONTAINER,500.0 TABLET CONTAINER,100.0 TABLET CONTAINER,1000.0 TABLET CONTAINER
892NDA/MAL/HDP/1738ALCON PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.TEARS NATURALE IINATURAL TEARS15MLALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUMBELGIUMOPHTHALMIC DROPS1.0X15.0 ML BOTTLE
893NDA/MAL/HDP/1746MISSION PHARMA A/SJOINT MEDICAL STORE (UPMB - UCMB)PRAZIQUANTELPRAZIQUANTEL USP600MGCSPC OUYI PHARMACEUTICAL CO.LTD. LIMITED-NO. 276, WEST ZHONGSTAN ROAD, SHIJIAZHUANG, CHINACHINAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER
894NDA/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 BLISTER
895NDA/MAL/HDP/1748AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAZ-500AZITHROMYCIN500MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY CAPSULES1.0X3.0 CAPSULE BLISTER
896NDA/MAL/HDP/1749LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDVITAMIN B COMPLEXVITAMIN B COMPLEXN/ALINCOLN PARENTERAL LTD-11, TRIMUL ESTATE KHATRAJ DISI. GANDHINAGAR-38272, GUJARATINDIAPARENTERAL ORDINARY AMPOULES1.0X10.0X10.0X2.0 ML AMPOULE
897NDA/MAL/HDP/1761EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDATAZOR-RATAZANAVIR + RITONAVIR300 MG + 100 MGEMCURE PHARMACEUTICALS LTD .-PLOT NO. P-2 IT-BT PARK PHASE II MIDC HINJWADI PUNE 411057INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X30.0 TABLET BOTTLE
898NDA/MAL/HDP/1763LABORATORY&ALLIED LTDHARLEYS UGANDA LIMITEDASPIRIN TABLETS BPACETYL SALICYLIC ACID300MGLABORATORY & ALLIED LTD.-PLOT 209/10349 OFF MOMBASA RD NAIROBIKENYAORAL SOLID ORDINARY TABLETS1.0X20.0X10.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER
899NDA/MAL/HDP/1764JOHNSON &JOHNSON (PTY) LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDFRESH BURST LISTERINEALCOHOL + THYMOL95 % W/V + 12 MGJOHNSON&JOHNSON PTY LTD..-241 MAIN ROAD RETREAT 794
SOUTH AFRICAORAL LIQUID ORDINARY LIQUIDS1.0X250.0 ML CONTAINER,1.0X500.0 ML CONTAINER
900NDA/MAL/HDP/1766RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDCOLDEASE CAPSULESPARACETAMOL+CAFFEINE CITRATE+CHLORPHENIRAMINE MALEATE+PSEUDOEPHEDRINE HYDROCHLORIDE400MG+30MG+4MG+30MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKAUGANDAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER
901NDA/MAL/HDP/1767EVA PHARMAWIDE SPECTRUM ENTERPRISES (U) LIMITEDPROSTEROLALFUZOSIN HYDROCHLORIDE10MGEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPTEGYPTORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER
902NDA/MAL/HDP/1768GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDULTIVA INJECTION 2MGREMIFENTANIL2MGGLAXOSMITHKLINE LTD MANUFACTURING SPA-VERONAITALYPARENTERAL ORDINARY DRY VIALS1.0X1.0 VIAL CARTON
903NDA/MAL/HDP/1769GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDENGERIX-B VACCINEHEPATITIS B SURFACE ANTIGEN10MCG/MLGLAXOSMITHKLINE BOILOGICALS-S.A RUE DE I'INSTITUT 89 B-1330 RIXENSARTBELGIUMPARENTERAL ORDINARY VIALS1.0X10.0X0.5 ML VIAL (1 DOSE),1.0X25.0X0.5 ML VIAL (1 DOSE)
904NDA/MAL/HDP/1771MISSION PHARMA A/SJOINT MEDICAL STORE (UPMB - UCMB)ORAL REHYDRATION SALTS BPMULTI-INGREDIENTMULTI-INGREDIENTMEDICAMEN BIOTECH LTD-SP-1192, A &B, PHASE –IV,
INDUSTRIAL AREA BHIWADI -301019 DIST. ALWAR (RAJASTHAN)
INDIAORAL LIQUID ORDINARY UNIT DOSE POWDERS1.0X100.0X20.5 G SACHET
905NDA/MAL/HDP/1772SUN PHARMACEUTICAL INDUSTRIES LIMITEDSTAR PHARMACEUTICALS LTDGESTID TABLETSCOMPOUND MAGNESIUM TRISILICATE385MGSUN PHARMACEUTICAL INDUSTRIES LIMITED,-INDUSTRIAL AREA NO.3, A.B.ROAD DEWAS,455001 MADHYA PRADESH INDIA.INDIAORAL SOLID ORDINARY TABLETS1.0X5.0X4.0 TABLET BLISTER
906NDA/MAL/HDP/1773MICRO LABS LTDLABOREX UGANDA LIMITEDLEVOBACT 500LEVOFLOXACIN HEMIHYDRATE500MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X20.0X5.0 TABLET BLISTER
907NDA/MAL/HDP/1777CIPLA LTDQUALITY CHEMICALS LTD - HUMANNUZAC 20FLUOXETINE20MGCIPLA LTD -PLOT NO. L-139, VERNA, GOA 403 722 INDIAINDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER
908NDA/MAL/HDP/1778PHARCO PHARMACEUTICALSWIDE SPECTRUM ENTERPRISES (U) LIMITEDFARCONCIL 500MG CAPSULESAMOXYCILLIN TRIHYDRATE500MGPHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT.
P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT
EGYPTORAL SOLID ORDINARY CAPSULES1.0X2.0X10.0 CAPSULE BLISTER
909NDA/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
910NDA/MAL/HDP/1780RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDRENETRIM SUSPENSIONCO-TRIMOXAZOLE240MG/5MLRENE INDUSTRIES LIMITED-PLOT 680 KAMULI KIREKAUGANDAORAL LIQUID ORDINARY SUSPENSIONS1.0X60.0 ML BOTTLE
911NDA/MAL/HDP/1781ASTRAZENECAMACNAUGHTON LIMITEDARIMIDEXANASTROZOLE1MGASTRAZENECA PHARMACEUTICALS LP-NEWARK, DELAWAREUNITED STATESORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X14.0 TABLET BLISTER
912NDA/MAL/HDP/1782AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDCO-METHERARTEMETHER + LUMEFANTRINEPER 5ML: 15MG + 90MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X60.0 ML BOTTLE,1.0X30.0 ML BOTTLE
913NDA/MAL/HDP/1783LABORATORY AND ALLIED LTDHARLEYS UGANDA LIMITEDLAEOVATE OINTMENTBETAMETHASONE VALERATE0.1%W/WLABORATORY & ALLIED LTD--PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, MOMBASA ROAD P.O. BOX 42875, GPO 00100, NAIROBI, KENYAKENYATOPICAL EXTERNAL OINTMENTS1.0X1.0X15.0 G TUBE
914NDA/MAL/HDP/1784MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDAZICURE-500AZITHROMYCIN500MGMACLEODS PHARMACEUTICALS LIMITED (BLOCK –N1)-VILLAGE THEDA, P.O. LODHI MAJRA,TEHSIL BADDI, HIMACHAL PRADESH -174101,INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X3.0 TABLET BLISTER
915NDA/MAL/HDP/1785BETA HEALTHCAREBETA HEALTHCARE UGANDA LIMITEDACTION TABLETSACETYL SALICYLATE + CAFFEINE + PARACETAMOL600MG+50MG+300MGBETA HEALTHCARE INTERNATIONAL LTD - -PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYAKENYAORAL SOLID ORDINARY TABLETS1.0X200.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,1.0X110.0 TABLET STRIP,1.0X12.0 TABLET BLISTER
916NDA/MAL/HDP/1786AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGONAC TABLETS (THANE)DICLOFENAC50MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
917NDA/MAL/HDP/1790REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDUNITRIM TABLETCO-TRIMOXAZOLE480MGREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL SOLID ORDINARY TABLETS10.0X10.0 TABLET BLISTER,1.0X250.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER
918NDA/MAL/HDP/1793MACNAUNGHTON LIMITEDMACNAUGHTON LIMITEDSYMBICORT TURBUHALERBUDESONIDE+FORMOTEROL80MCG+4.5MCG/DOSEASTRAZENECA AB,-GARTUNA & SNACKVIKEN STOCKHOLMSWEDENLUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER1.0X60.0 DOSE CANNISTER
919NDA/MAL/HDP/1795KOPRAN LIMITEDTATA UGANDA LIMITEDAMPIK-250AMPICILLIN250MGKOPRAN LIMITED-VILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIAINDIAORAL SOLID ORDINARY CAPSULES10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER
920NDA/MAL/HDP/1796AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDZAHA 250AZITHROMYCIN250 MGAJANTA PHARMA LTD .-B-4//5/6, MIDC INDUSTRIALAREA, PAITHAN-431 128, AURANGBADINDIAORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER,1.0X10.0X1.0X6.0 TABLET BLISTER
921NDA/MAL/HDP/1797KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTDTATA UGANDA LIMITEDAMPICILLIN+CLOXACILLINAMPICILLIN + CLOXACILLIN250 MG + 250 MGKARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD- #14, II PHASE PIA, BANGALORE 560058INDIAPARENTERAL ORDINARY DRY VIALS1.0X10.0X500.0 MG VIAL
922NDA/MAL/HDP/1798INTAS PHARMACEUTICALS LIMITEDNORVIK ENTERPRISES LIMITEDCARDITAS RETARDNIFEDIPINE20MGINTAS PHARMACEUTICALS LTD, VATVA-7/3 G.I.D.C. ESTATE, PHASE-1, B/H DENA BANK VATVA, AHMEDABAD-382 445 GUJARAT, INDIA
,INTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIA
INDIAORAL SOLID RETARD FILM-COATED TABLETS10.0X10.0 TABLET BLISTER
923NDA/MAL/HDP/1799INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDSECZOL DSSECNIDAZOLE1GMINTAS PHARMACEUTICALS LTD-PLOT 457/458, SARKHEJ BAVLA HIGHWAY
MATODA 382 210 TAL: SANAND, AHMEDABAD, INDIA
INDIAORAL SOLID ORDINARY TABLETS1.0X2.0 TABLET BLISTER
924NDA/MAL/HDP/1800MICRO LABS LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDAMLONG-10AMLODIPINE5MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER
925NDA/MAL/HDP/1801LABORATORY AND ALLIED LTDHARLEYS UGANDA LIMITEDLABESTEN PESSARIESCLOTRIMAZOLE100MGLABORATORY & ALLIED LTD.---PLOT 209/10349 OFF MOMBASA RD NAIROBIKENYAVAGINAL TABLETS1.0X1.0X6.0 PESSARY STRIP
926NDA/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 CARTON
927NDA/MAL/HDP/1804TORRENT PHARMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.LISTRILLISINOPRIL5MGTORRENT PHARMACEUTICAL LTD-AHMEDABAD-MEHSANA HIGHWAY,TALUKA-KADI,DIST.MEHSANA,INDRAD-382721INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER
928NDA/MAL/HDP/1805MSD (PTY) LIMITED SAPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDJANUMETSITAGLIPTIN + METFORMIN HYDROCHLORIDE50MG + 1000MGAESICA QUEESNBOROUGH LTD .-NORTH ROAD, QUEENBOROUGH KENT ME 11 5EL, UNITED KINGDOMUNITED KINGDOMORAL SOLID ORDINARY FILM-COATED TABLETS1.0X4.0X14.0 TABLET BLISTER
929NDA/MAL/HDP/1807GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDAMPICLOX NEONATAL DROPSAMPICILLIN + CLOXACILLIN60 MG / 0.6 ML + 30 MG / 0.6 MLMEDREICH STERILAB LTD-12TH MILE, OLD MADRAS ROAD, VIRGONAGOR, BANGALORE 560049, INDIAINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X8.0 ML BOTTLE
930NDA/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 BLISTER
931NDA/MAL/HDP/1809AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOVIT-6PYRIDOXINE25MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
932NDA/MAL/HDP/1810AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOTRITRIFLUOPERAZINE5MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
933NDA/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, KAMPALAINDIAORAL SOLID ORDINARY TABLETS1.0X6.0X10.0 TABLET BLISTER,1.0X60.0 TABLET BOTTLE
934NDA/MAL/HDP/1812RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDREQUIN TABLETSQUININE SULPHATE300MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKAUGANDAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
935NDA/MAL/HDP/1813DAWA LIMITEDSUPER MEDIC LTDMOXAFORTEAMOXICILLIN + FLUCLOXACILLIN125 MG + 125MGDAWA LTD-BABA DOGO ROAD RUARAKAKENYAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE
936NDA/MAL/HDP/1815GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDSUPIROCIN OINTMENTMUPIROCIN2%W/WGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,DINDIATOPICAL EXTERNAL OTHER OINTMENTS1.0X15.0 G TUBE
937NDA/MAL/HDP/1816MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDDRESS UP CREAMNEOMYCIN SULPHATE0.5%W/WTORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506INDIATOPICAL EXTERNAL CREAMS1.0X30.0 G TUBE
938NDA/MAL/HDP/1822RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDEPHEDRINEEPHEDRINE HYDROCHLORIDE30MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKAUGANDAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER
939NDA/MAL/HDP/1824NABIQASIM INDUSTRIES (PVT) LIMITEDJEET PHARMACEUTICALS LIMITEDGLANDIN E2 GELDINOPROSTONE0.5MGNABIQASIM INDUSTRIES (PVT) LTD?-17/24,KORANGI INDUSTRIAL AREA, KORANGI, KARACHI- PAKISTAN.
PAKISTANTOPICAL EXTERNAL GELS AND SOLS1.0X3.0 G TUBE WITH STERILE CATHETER
940NDA/MAL/HDP/1825RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDCOLDEASE SYRUPPARACETAMOL+CHLORPHENIRAMINE MALEATE+PSEUDOEPHEDRINE HYDROCHLORIDE120MG+2MG+15MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKAUGANDAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE
941NDA/MAL/HDP/1826WIN-MEDICARE LTDSURGIPHARM (U) LIMITEDLOGICAN-200FLUCONAZOLE200MGWIN-MEDICARE PRIVATE LIMITED-MEERUT-MUZAFFARNAGAR ROAD, MODIPURAM - 250110 UTTAR PRADESHINDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X4.0 CAPSULE BLISTER
942NDA/MAL/HDP/1827REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDALBASOL SUSPENSIONALBENDAZOLE200MG/5MLREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL LIQUID ORDINARY SUSPENSIONS1.0X10.0 ML BOTTLE
943NDA/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 BLISTER
944NDA/MAL/HDP/1832ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDDICLOASDICLOFENAC SODIUM50MGASTRA LIFE CARE(INDIA) PVT LTD-57/P, POJODA, 382220, BOVIA, AHMEDOBAD, INDIAINDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X5.0X20.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
945NDA/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 BLISTER
946NDA/MAL/HDP/1838INDOCO REMEDIES LIMITEDTATA UGANDA LIMITEDABZEEALBENDAZOLE400MGINDOCO REMEDIES LTD-B-20, MIDC, WALUJ, AURANGABAB 431136 INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X1.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER
947NDA/MAL/HDP/1840REMEDICA LTDGOODMAN INTERNATIONAL LTDOVA-MITCLOMIPHENE50MGREMEDICA LIMITED -AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUSCYPRUSORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER
948NDA/MAL/HDP/1841MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDFUNGNIL CREAMCLOTRIMAZOLE1%W/WTORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506INDIATOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE
949NDA/MAL/HDP/1842KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDSUGAQUIN TABLETSCHLOROQUINE PHOSPHATE250MGKAMPALA PHARMACEUTICALS INDUSTIES-PLOT NO M44B STRETCHER ROAD INTINDAUGANDAORAL SOLID ORDINARY OTHER COATED TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
950NDA/MAL/HDP/1843USV LIMITEDABACUS PHARMA (AFRICA) LIMITEDECORIN-75ASPIRIN75MGREMEDEX PHARMA-B-249/250 PEENYA INDUSTRIAL ESTATE BANGALORE 560 058
INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER
951NDA/MAL/HDP/1844GUILIN PHARMACEUTICALS CO.LTDSTAR PHARMACEUTICALS LTDSULFAMETHOXAZOLE / TRIMETHOPRIMSULFAMETHOXAZOLE / TRIMETHOPRIM800MG /160MGGUILIN PHARMACEUTICAL CO.LTD.-NO.43 QUILIDIAN ROAD GUILIN 541002, GUANGXI, CHINACHINAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
952NDA/MAL/HDP/1846LEBEN LABORATORIES PVT LTDANDYCO PHARMACY (UGANDA) LTDANTAGIT DS GEL ORANGE FLAVOURALUMINIUM HYDROXIDE + MAGNESIUM + SIMETHICONE400MG + 400MG + 50MGLEBEN LABORATORIES PVT. LTD.-PLOT NO. L-4, PHASE –III, M.I.D.C, AKOLA, 444104, MAHARASHTRA, INDIA.INDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X170.0 ML BOTTLE
953NDA/MAL/HDP/1847LEBEN LABORATORIES PVT. LTD., INDIAANDYCO PHARMACY (UGANDA) LTDMOXILEB-250 CAPSULEAMOXICILLIN250MGLEBEN LABORATORIES PVT. LTD.-PLOT NO. L-4, PHASE –III, M.I.D.C, AKOLA, 444104, MAHARASHTRA, INDIA.INDIAORAL SOLID ORDINARY CAPSULES1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0X10.0 CAPSULE BLISTER
954NDA/MAL/HDP/1848LABORATORY&ALLIED LTDHARLEYS UGANDA LIMITEDPARATALPARACETAMOL500MGLABORATORY & ALLIED LTD--PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, MOMBASA ROAD P.O. BOX 42875, GPO 00100, NAIROBI, KENYAKENYAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER
955NDA/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 BOTTLE
956NDA/MAL/HDP/1850RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDALZOL TABLETSALBENDAZOLE400MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL SOLID ORDINARY TABLETS1.0X500.0 TABLET CONTAINER
957NDA/MAL/HDP/1851PHILLIPS PHARMACEUTICALS LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDCAPSIFENAC GELCAPSAICIN + DICLOFENAC + LEVOMENTHOL + METHYL SALICYLATE0.438 G + 0.335 G + 0.135 G + 0.918 GSTEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIAINDIATOPICAL EXTERNAL EMULSION GELS1.0X1.0X20.0 G TUBE,1.0X1.0X10.0 G TUBE
958NDA/MAL/HDP/1853MSD (PTY) LIMITED SAPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDAERIUS ORAL SOLUTIONDESLORATADINE0.5MG/ML MSD (PTY) LTD- LOCATED AT 117 16TH ROAD HALFWAY HOUSE SOUTH AFRICA,SCHERING-PLOUGH LABO N.V--INDUSTRIE PARK 30, ZONE A 2220 HEIST-OP-DEN-BERGBELGIUMORAL LIQUID ORDINARY SYRUPS1.0X1.0X60.0 ML BOTTLE,1.0X150.0 ML BOTTLE
959NDA/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 AREAKENYAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
960NDA/MAL/HDP/1861GUILIN PHARMACEUTICALS CO LTDSTAR PHARMACEUTICALS LTDSULFAMETHOXAZOLE / TRIMETHOPRIMSULFAMETHOXAZOLE / TRIMETHOPRIM400MG /80MGGUILIN PHARMACEUTICAL CO.LTD.-NO.43 QUILIDIAN ROAD GUILIN 541002, GUANGXI, CHINACHINAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
961NDA/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 TUBE
962NDA/MAL/HDP/1864NORVATIS PHARMA AG- SWITZERLANDLABOREX UGANDA LIMITEDPATANOLOLOPATADINE HYDROCHLORIDE0.1%W/VALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUMBELGIUMOPHTHALMIC DROPS1.0X5.0 ML VIAL
963NDA/MAL/HDP/1865FDC LTDAIVEEN (U) LIMITEDMYCODERM-C POWDERCLOTRIMAZOLE1%W/WFDC LIMITED -B-8, M.I.D.C., INDUSTRIAL AREA, WALUJ – AURANGABAD- 431 136 MAHARASHTRA, INDIA. INDIATOPICAL EXTERNAL POWDERS1.0X75.0 G CONTAINER
964NDA/MAL/HDP/1866JASSEN-CILAG (PTY) LTDLABOREX UGANDA LIMITEDNIZORALKETOCONAZOLE20MG/GSPECPHARM HOLDINGS- 15TH ROAD HALFWAY HOUSESOUTH AFRICATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE
965NDA/MAL/HDP/1867RENE PHARMACY(R) LTD..RENE PHARMACY LTDLEVATEX TABLETSLEVAMISOLE HYDROCHLORIDE40MGCYANO PHARMA(P)-115-C IND ESTATE POLOGROUND, INDORE 452015INDIAORAL SOLID ORDINARY TABLETS500.0 TABLET CONTAINER,1.0X10.0X3.0 TABLET BLISTER
966NDA/MAL/HDP/1869MERCK SHARP & DOHME BVPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDSTOCRIN 200EFAVIRENZ200MG ZHEJIANG HUAHAI PHARMACEUTICAL CO. LTD-XUNQIAO, LINHAI, ZHEJIANG PROVINCE 317024 PEOPLES’ REPUBLIC OF CHINA,MERCK SHARP & DOHME.-WAADERWAG 39, POSTBUS 581. 2003 PC HAARLEMNETHERLANDSORAL SOLID ORDINARY FILM-COATED TABLETS1.0X90.0 TABLET BOTTLE
967NDA/MAL/HDP/1873MSD (PTY) LIMITED SAPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDJANUMETSITAGLIPTIN + METFORMIN HYDROCHLORIDE50MG + 850MGAESICA QUEESNBOROUGH LTD .-NORTH ROAD, QUEENBOROUGH KENT ME 11 5EL, UNITED KINGDOMUNITED KINGDOMORAL SOLID ORDINARY TABLETS1.0X4.0X14.0 TABLET BLISTER
968NDA/MAL/HDP/1877RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDMINT-O-COOLDRIED ALUMINIUM HYDROXIDE + MAGNESIUM TRISILICATE120MG + 250MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL SOLID ORDINARY TABLETS1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER
969NDA/MAL/HDP/1879SPARSH BIO-TECH PVT LTDABACUS PHARMA (AFRICA) LIMITEDSPENIVPHENOXYMETHYL PENICILLIN250MGSPARSH BIO-TECH LTD-PLOT NO.1 SURVEY NO.242/234/244, VILLAGE LAKHABARAD, JAMNAGAR-361006INDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
970NDA/MAL/HDP/1880SPARSH BIO-TECH PVT. LTDABACUS PHARMA (AFRICA) LIMITEDSPAMCLOXAMPICILLIN + CLOXACILLIN250 MG + 250 MGSPARSH BIO-TECH LTD-PLOT NO.1 SURVEY NO.242/234/244, VILLAGE LAKHABARAD, JAMNAGAR-361006INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER,1.0X100.0X10.0 CAPSULE BLISTER
971NDA/MAL/HDP/1881SPARSH BIO-TECH PVT. LTDABACUS PHARMA (AFRICA) LIMITEDSPAMOXAMOXYCILLIN250MGSPARSH BIO-TECH PVT. LIMITED-PLOT NO. 1;SURVEY NO. 242/243/244,LAKHABAVAD,JAMNAGAR-361 006, INDIA.
INDIAORAL SOLID ORDINARY CAPSULES1.0X100.0X10.0 CAPSULE BLISTER,1.0X1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER
972NDA/MAL/HDP/1882SPARSH BIO-TECH PVT LTDABACUS PHARMA (AFRICA) LIMITEDSPAMCILAMPICILLIN250MGSPARSH BIO-TECH LTD-PLOT NO.1 SURVEY NO.242/234/244, VILLAGE LAKHABARAD, JAMNAGAR-361006INDIAORAL SOLID ORDINARY CAPSULES1.0X100.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER
973NDA/MAL/HDP/1886KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAM QUIN TABLETSCHLOROQUINE PHOSPHATE250MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALAUGANDAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER
974NDA/MAL/HDP/1887KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMADOLPARACETAMOL500MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALAUGANDAORAL SOLID ORDINARY TABLETS1.0X100.0X10.0 TABLET BLISTER,100.0 TABLET CONTAINER,250.0 TABLET CONTAINER,500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
975NDA/MAL/HDP/1888KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAM QUIN SYRUPCHLOROQUINE PHOSPHATE80MG/5MLKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD-PLOT M 444B STRETCHER ROAD NTINDAUGANDAORAL LIQUID ORDINARY SYRUPS1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE
976NDA/MAL/HDP/1889KAMPALA PHARMACEUTICAL INDUSTRIES LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAM PREDSOLPREDNISOLONE5MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALAUGANDAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X500.0 TABLET CONTAINER,1.0X250.0 TABLET CONTAINER,1.0X100.0 TABLET CARTON,1.0X10.0 TABLET CARTON
977NDA/MAL/HDP/1891MACLEODS PHARMACEUTICAL LTDNORVIK ENTERPRISES LIMITEDLEVOMAC 500LEVOFLOXACIN500MGMACLEODS PHARMACEUTICALS LTD -PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT), INDIA.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X20.0X5.0 TABLET BLISTER
978NDA/MAL/HDP/1892MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDLEVOMAC 250LEVOFLOXACIN250MGMACLEODS PHARMACEUTICALS LTD -PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT), INDIA.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X20.0X5.0 TABLET BLISTER
979NDA/MAL/HDP/1894KOPRAN LIMITEDTATA UGANDA LIMITEDTRIM-480CO-TRIMOXAZOLE480MGKOPRAN LIMITED-VILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIAINDIAORAL SOLID ORDINARY TABLETS10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
980NDA/MAL/HDP/1895AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDTRIMAGO (PAEDIATRIC)CO-TRIMOXAZOLE100MG/20MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER
981NDA/MAL/HDP/1898WIN-MEDICARE LTDSURGIPHARM (U) LIMITEDZAPACID - 30LANSOPRAZOLE30MGWIN MEDICARE PVT LIMITED-MEERUT, MUZAFFARNAGER ROAD, MODIPURAM – 250110, UTTAR
PRADESH - INDIA
INDIAORAL SOLID ORDINARY CAPSULES3.0X10.0 CAPSULE BLISTER
982NDA/MAL/HDP/1899INDOCO REMEDIES LIMITEDTATA UGANDA LIMITEDTUSPRESS COUGH SUPPRESSANTMULTI-INGREDIENTMULTI-INGREDIENTINDOCO REMEDIES LTD - 0-.L-14 VERNA INDUSTRIAL AREA, VERNA, GOA-403722INDIAORAL LIQUID ORDINARY SYRUPS1.0X1.0X100.0 ML BOTTLE
983NDA/MAL/HDP/1900AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOM 20OMEPRAZOLE20MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY CAPSULES1.0X2.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE STRIP
984NDA/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 BOTTLE
985NDA/MAL/HDP/1902KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMODIUMLOPERAMIDE HYDROCHLORIDE2MGKAMPALA PHARMECEUTICALS INDUSTRIES LTD.-PLOT M444B STRETCHER RD, NTINDA KLA UGANDAUGANDAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER
986NDA/MAL/HDP/1903DAFRA PHARMA LTDLABOREX UGANDA LIMITEDARTESIANE 100ARTEMETHER100MG/MLROTEXMEDICA GMBH ARZEIMITTEL WERK-BUNSENSTRASSE 4, 22946 TRITTAUGERMANYPARENTERAL ORDINARY I M AMPOULES1.0X10.0X1.0 ML AMPOULE
987NDA/MAL/HDP/1905ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDOXYTOCIN INJECTIONOXYTOCIN10I.U/MLZHEJIANG RUIXIN PHARMACEUTICAL CO. LTD-KAIFA ROAD, LISHUI, ZHEJIANG P.R OF CHINACHINAPARENTERAL ORDINARY AMPOULES1.0X10.0X1.0 ML AMPOULE,1.0X100.0X1.0 ML AMPOULE
988NDA/MAL/HDP/1906ACG PHARMAPACK PVT. LTDCIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDEFAVIRENZ TABLETS 600MGEFAVIRENZ600MGCIPLA QUALITY CHEMICAL INDUSTRIES LIMITED-PLOT 1-7, LUZIRAUGANDAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X30.0 TABLET CONTAINER
989NDA/MAL/HDP/1907CIPLA LTDQUALITY CHEMICALS LTD - HUMANABACAVIRABACAVIR300MGCIPLA LTD-UNIT I & II A-32 & A-42 MIDC PATALGANGA 410220, DIST- RAIGAD, MAHARASHTRA, INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X60.0 TABLET BOTTLE
990NDA/MAL/HDP/1908CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDOLMY 20OLMESARTAN20MGCADILA HEALTH CARE LIMITED-KUNDAIM INDUSTRIAL ESTATE, PONDA, GOA-403401, INDIA.
.
INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER
991NDA/MAL/HDP/1911COSMOS LTDASTRA PHARMA (U) LIMITEDCODIENE PHOSPHATE TABLETS BP 30CODEINE PHOSPHATE30MGCOSMOS LIMITED -RANGWA ROAD, OFF LUNGA LUNGA ROAD, INDUSTRIAL AREAKENYAORAL SOLID ORDINARY TABLETS1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
992NDA/MAL/HDP/1912MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDD-WORMALBENDAZOLE200MGTORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506INDIAORAL SOLID ORDINARY TABLETS1.0X2.0 TABLET BLISTER
993NDA/MAL/HDP/1914RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDCHLORPHENIRAMINECHLORPHENIRAMINE4MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER
994NDA/MAL/HDP/1915HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDATAZANAVIR SULPHATE + RITONAVIRATAZANAVIR SULPHATE + RITONAVIR300 MG + 100 MGHETERO LABS LTD UNIT III-22-110 IDA JEEDIMETIA HYDERABAD ANDHRA PRADESH ,,HETERO LABS LTD (UNIT-V)-SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET CONTAINER
995NDA/MAL/HDP/1919GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDCANDIDERM CREAMBECLOMETASONE/CLOTRIMAZOLE/GENTAMYCIN0.025%W/W+1%W/W+0.1%W/WGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,DINDIATOPICAL EXTERNAL CREAMS1.0X5.0 G TUBE,1.0X15.0 G TUBE
996NDA/MAL/HDP/1920STRIDES ARCOLAB LTDROYAL PHARMA 2011 LIMITEDASCORBIC ACID TABLETASCORBIC ACID100MG STRIDES ARCO LAB LTD-K.R.S GARDENS SURAGAJAKKANAHALLI,INDLAWADI CROSS ANEKAL TALUK,BANGALOREINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
997NDA/MAL/HDP/1922IPCA LABORATORIES LIMITEDMEDVIN PHARMA LIMITEDAZIFAST-500AZITHROMYCIN500MG IPCA LABORATORIES LTD,PLOT NO. T-139 -SEJAVTA, RATLAM-457 002 (M.P.) INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X3.0 TABLET BLISTER
998NDA/MAL/HDP/1923GALENTIC PHARMA (PVT)LTDNORVIK ENTERPRISES LIMITEDBETAMETHASONEBETAMETHASONE0.1%W/WGALENTIC PHARMA( INDIA ) PVT LTD-R-673,MIDC TTC RABALE THANE-BELAPUR ROAD,NAVIINDIATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE
999NDA/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-INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER
1000NDA/MAL/HDP/1927REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDINTAPLEX TABLETVITAMIN B COMPOUNDN/AREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL SOLID ORDINARY TABLETS1.0X100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
1001NDA/MAL/HDP/1929CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDATORVA 40ATORVASTATIN40MGCADILA HEALTH CARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER
1002NDA/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 IMPLANT
1003NDA/MAL/HDP/1932ELYS CHEMICAL INDUSTRIES LTDVELVET PHARMA LIMITEDCANDISTAT CREAMCLOTRIMAZOLE1%W/WELYS CHEMICAL INDUSTRIES LIMITED-ROAD B’, OFF ENTERPRISE ROAD
PLOT NO. 209/8927 INDUSTRIAL AREA
KENYAORAL TOPICAL CREAMS1.0X20.0 G TUBE
1004NDA/MAL/HDP/1934RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDRENECHLOR SUSPENSIONCHLORAMPHENICOL125MG/5MLRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKAUGANDAORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE
1005NDA/MAL/HDP/1935NABIQASIM INDUSTRIES (PVT) LTD.JEET PHARMACEUTICALS LIMITEDSULPHA KREAM-NSULPHANILAMIDE15%W/WNABIQASIM INDUSTRIES (PVT) LTD--17/24,KORANGI INDUSTRIAL AREA, KORANGI, KARACHI- PAKISTAN.PAKISTANTOPICAL EXTERNAL CREAMS1.0X1.0X80.0 G TUBE
1006NDA/MAL/HDP/1936GLAXO SMITH KLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDPIRITON EXPECTORANTCHLORPHENIRAMINE MALEATE + AMMONIUM CHLORIDEMULTINGREDIENTGLAXO WELLCOME (KENYA) LTD-KENYAKENYAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE
1007NDA/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 CONTAINER
1008NDA/MAL/HDP/1938YURIA PHARM EAST AFRICA LIMITEDYURIA PHARM EAST AFRICA LIMITEDINFULGANPARACETAMOL10MG/MLYURIA-PHARM, LTD.-18030 VERBOVETSKOGO STR. 108 CHERKASSY, UKRAINE.UKRAINEPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X100.0 ML BOTTLE,1.0X20.0 ML BOTTLE
1009NDA/MAL/HDP/1940REMEDICA LTDGOODMAN INTERNATIONAL LTDCLOXACILLIN CAPSULESCLOXACILLIN SODIUM250MGREMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHARCYPRUSORAL SOLID ORDINARY CAPSULES10.0X10.0 CAPSULE BLISTER
1010NDA/MAL/HDP/1941CADILA PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.RABELOC IVRABEPRAZOLE20MG/VIALCADILA PHARMACEUTICALS LTD.-1389, TRASAD ROAD, DHOLKA 387810 DISTRICT AHMEDABAD GUJARAT STATEINDIAPARENTERAL ORDINARY VIALS1.0X5.0 ML VIAL
1011NDA/MAL/HDP/1942RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDAMCLORENAMPICILLIN + CLOXACILLIN250 MG + 250 MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKAUGANDAORAL SOLID ORDINARY CAPSULES1.0X100.0 CAPSULE CONTAINER
1012NDA/MAL/HDP/1943MODI MUNDI PHARMA PVT LTDSURGIPHARM (U) LIMITEDNITROCONTIN 2.6NITROGLYCERIN (CONTROLLED RELEASE)2.6MGMODI MUNDIPHARMA (PVT) LTD-MEERUT - MUZAFFARNAGAR ROAD, MODIPURAM, UTTAR PRADESH ESTATEINDIAORAL SOLID RETARD TABLETS1.0X25.0 TABLET CONTAINER
1013NDA/MAL/HDP/1946WIN-MEDICARE LTDSURGIPHARM (U) LIMITEDSOLUDOL TABLETSDICLOFENAC SODIUM50MGWIN MEDICARE PVT LIMITED-MEERUT, MUZAFFARNAGER ROAD, MODIPURAM – 250110, UTTAR
PRADESH - INDIA
INDIAORAL SOLID ORDINARY SOLUBLE TABLETS10.0X10.0 TABLET STRIP
1014NDA/MAL/HDP/1948PFIZER LABORATORIES PTY LTDLABOREX UGANDA LIMITEDZITHROMAXAZITHROMYCIN DIHYDRATE500MGHAUPT PHARMA LATINA S.R.L LATINA-SS 156KM 47,600-04100,BORGO SAN,MICHELE, PFIZER LABORATORIES (PTY) LTD;--SOUTH AFRICASOUTH AFRICAORAL SOLID ORDINARY TABLETS1.0X3.0 TABLET BLISTER,1.0X2.0 TABLET BLISTER
1015NDA/MAL/HDP/1949MACLEODS PHARMACEUTICALS LTDS LTDNORVIK ENTERPRISES LIMITEDTRENAXA 500TRANEXAMIC ACID500MGMACLEODS PHARMACEUTICALS -PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT), INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X5.0X6.0 TABLET BLISTER
1016NDA/MAL/HDP/1951MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDCLOPI 75CLOPIDOGREL75MGMACLEODS PHARMACEUTICALS -PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT), INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET STRIP,3.0X10.0 TABLET STRIP
1017NDA/MAL/HDP/1952JOHNSON &JOHNSON (PTY) LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDNIZORALKETOCONAZOLE20MG/GSPECPHARM HOLDINGS- 15TH ROAD HALFWAY HOUSESOUTH AFRICATOPICAL EXTERNAL LIQUID SOAPS/WASHES1.0X80.0 ML BOTTLE
1018NDA/MAL/HDP/1953UNIQUE PHARMACEUTICALS LABORATORIESTATA UGANDA LIMITEDRANTAB-150RANITIDINE150MGUNIQUE PHARMACEUTICAL LABORATORIES (A DIV. OF J.B CHEMICALS & PHARMACEUTICALS LTD)--216-219 GIDC INDUSTRIAL AREA PANOLI 394 116 DIST BHARUCHINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER
1019NDA/MAL/HDP/1954: ALKEM LABORATORIES LIMITED?ABACUS PHARMA (AFRICA) LIMITEDRAPEED-20RABEPRAZOLE20MGALKEM LABORATORIES LTD .-VILLAGE THANA, BADDI, TEHSIL-NALAGARH, DISTT-SOLAN, (HP), INDIA-173205INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET STRIP,1.0X1.0X10.0 TABLET STRIP
1020NDA/MAL/HDP/1955MILAN LABORATORIES LTDGITTOES PHARMACEUTICALS LIMITEDMILCILLINAMPICILLIN250MGMILAN LABORATORIES -PLOT NOS 63, 67 & 87, JAWAHAR CO-OP. INDUSTRIAL
ESTATE LTD., KAMOTHE, PANVEL (NAVI MUMBAI).
INDIAORAL SOLID ORDINARY CAPSULES1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER
1021NDA/MAL/HDP/1956MILAN LABORATORIES LTDGITTOES PHARMACEUTICALS LIMITEDMILOXYAMOXYCILLIN250MGMILAN LABORATORIES -PLOT NOS 63, 67 & 87, JAWAHAR CO-OP. INDUSTRIAL
ESTATE LTD., KAMOTHE, PANVEL (NAVI MUMBAI).
INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER
1022NDA/MAL/HDP/1957MILAN LABORATORIES LTDGITTOES PHARMACEUTICALS LIMITEDMILCILLINAMPICILLIN125MG/5MLMILAN LABORATORIES -PLOT NOS 63, 67 & 87, JAWAHAR CO-OP. INDUSTRIAL
ESTATE LTD., KAMOTHE, PANVEL (NAVI MUMBAI).
INDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE
1023NDA/MAL/HDP/1958MILAN LABORATORIES LTDGITTOES PHARMACEUTICALS LIMITEDMILOXYAMOXYCILLIN125MG/5MLMILAN LABORATORIES -PLOT NOS 63, 67 & 87, JAWAHAR CO-OP. INDUSTRIAL
ESTATE LTD., KAMOTHE, PANVEL (NAVI MUMBAI).
INDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE
1024NDA/MAL/HDP/1959MILAN LABERATORIES PVT LTDGITTOES PHARMACEUTICALS LIMITEDBETRIM 480CO-TRIMOXAZOLE480MGMILAN LABORATORIES -PLOT NOS 63, 67 & 87, JAWAHAR CO-OP. INDUSTRIAL
ESTATE LTD., KAMOTHE, PANVEL (NAVI MUMBAI).
INDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
1025NDA/MAL/HDP/1960KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDDIFENACDICLOFENAC SODIUM50MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD -PLOT NO. M444B, STRETCHER ROAD, NTINDA, KAMPALA UGANDAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER
1026NDA/MAL/HDP/1962GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDNIMBEXCISATRACURIUM BESYLATE2MG/MLGLAXOSMITHKLINE S.P.A -STRADA PROVINCIALE ASOLANA 9ITALYPARENTERAL ORDINARY VIALS2.5 ML VIAL,1.0X10.0 ML VIAL
1027NDA/MAL/HDP/1963MILAN LABERATORIES PVT LTDGITTOES PHARMACEUTICALS LIMITEDDICLOFENAC GELDICLOFENAC1%W/WMILAN LABORATORIES -PLOT NOS 63, 67 & 87, JAWAHAR CO-OP. INDUSTRIAL
ESTATE LTD., KAMOTHE, PANVEL (NAVI MUMBAI).
INDIATOPICAL EXTERNAL GELS AND SOLS1.0X35.0 G TUBE
1028NDA/MAL/HDP/1964MILAN LABORATORIES LTDGITTOES PHARMACEUTICALS LIMITEDCLONEXCLOTRIMAZOLE1%W/WMILAN LABORATORIES -PLOT NOS 63, 67 & 87, JAWAHAR CO-OP. INDUSTRIAL
ESTATE LTD., KAMOTHE, PANVEL (NAVI MUMBAI).
INDIATOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE
1029NDA/MAL/HDP/1966MACK BROWN PHARMACEUTICALS PVT LIMITEDSHURIK LTDPARACINPARACETAMOL500MGTORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506INDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
1030NDA/MAL/HDP/1969NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDVOLTAREN SR 75MGDICLOFENAC SODIUM75MGNOVARTIS PHARMA SPA, TORRE ANNUNZIATA ITALY-NAITALYORAL SOLID RETARD TABLETS1.0X30.0 TABLET CONTAINER
1031NDA/MAL/HDP/1970MACK BROWN PHARMACEUTICALS PVT LIMITEDSHURIK LTDCETRAMACCETIRIZINE10MGTORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER
1032NDA/MAL/HDP/1971AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOMPICLOX ORAL SUSPENSIONAMPICILLIN + CLOXACILLIN125 MG/5ML + 125 MG/5MLMILAN LABORATORIES (INDIA ) PVT LTD-PLOT NO.63-67 & 87,JAWAHAR CO.OP.INDUSTRIAL ESTATE LTD KAMOTHE,PANVEL DIST. THANE,MAHARASTRA-410209,INDIAINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE
1033NDA/MAL/HDP/1974SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDCEFROTILCEFUROXIME AXETIL500MGSAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER
1034NDA/MAL/HDP/1975LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDBET-CODERM NBETAMETHASONE + NEOMYCIN0.1 W/W + 0.5 W/WLINCOLN PHARMACEUTICALS LTD-10, 11, 13, TRIMUL ESTATE KHATRAJ, NEAR KHATRAJ, CHOKADI , KHATRAJ-382721, GHANDINAGAR GUJARAT, INDIA
INDIATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE
1035NDA/MAL/HDP/1977UNICHEM LABORATORIES LTDEUROPA HEALTHCARE (U) LTDLOSA-HLOSARTAN + HYDROCHLOROTHIAZIDE50MG + 12.5MGUNICHEM LABORATORIES LIMITED-UNICHEM LABORATORIES LIMITED. UNIT II, VILLAGE BHATAULI KALAN, BADDI, DIST. SOLAN PIN CODE 173 205, HIMACHAL PRADESH, INDIA

INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER
1036NDA/MAL/HDP/1984ELI-LILLY (SUISSE) SALABOREX UGANDA LIMITEDCIALISTADALAFIL20MGLILLY SA, AVDA DE LA INDUSTRIA-LILLY SA, AVDA DE LA INDUSTRIA, 30 28108 ALCOBENDAS - MADRIDSPAINORAL SOLID ORDINARY TABLETS2.0X2.0 TABLET BLISTER
1037NDA/MAL/HDP/1985GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDPROXIMEXA ORAL SUSPENSION 250MG/5MLCEFUROXIME AXETIL250MG/5MLGLAXOSMITHKLINE UK LTD-HARMIRE RD BARNARD CASTLE DURHAM, DL12DT UNITEDUNITED KINGDOMORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X1.0X50.0 ML BOTTLE
1038NDA/MAL/HDP/1987FOURTS(INDIA) LABORATORIES PVT LTDDELMAW ENTERPRISES LIMITEDFOMYCETINCHLORAMPHENICOL250MGFOURRTS(INDIA) LABORATORIES PVT.LIMITED-VANDALUR ROAD,KELAMBAKKAM-603 103,
TAMIL NADU,INDIA
INDIAORAL SOLID ORDINARY CAPSULES1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER
1039NDA/MAL/HDP/1989FERRER INTERNACIONAL S.ALABOREX UGANDA LIMITEDDERMOFIXSERTACONAZOLE NITRATE2%W/WFERRER INTERNACIONAL,S.A.-GRAN VIA CARLOS III 94 BARCELONA (ESPANA /SPAIN)SPAINTOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE
1040NDA/MAL/HDP/1990UNICHEM LABORATORIES LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDTAGERA FORTESECNIDAZOLE1GUNICHEM LABORATORIES LTD---C31 & 32 INDUSTRIAL AREAINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X1.0X2.0 TABLET BLISTER
1041NDA/MAL/HDP/1991BEIJING HOLLEY COTEC PHARMA CHINASUPER PHARMACEUTICALS LIMITEDTETRACYCLINETETRACYCLINE250MGSHANDONG XIER KANGTAI PHARMACEUTICAL CO LTD-YANZHOU CITY, CHINACHINAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER,1.0X100.0X10.0 CAPSULE BLISTER
1042NDA/MAL/HDP/1994UNIQUE PHARMACEUTICALS LABORATORIESTATA UGANDA LIMITEDPANUM 40PANTOPRAZOLE40MGJ.B. CHEMICALS AND PHARMACEUTICALS LTD .-128/1, GIDC, ANKLESHWAR 393 002, GUJARATINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER
1043NDA/MAL/HDP/1997AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDTENA-100ATENOLOL100MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER
1044NDA/MAL/HDP/1998M.J.BIOPHARM PVT LTDTATA UGANDA LIMITEDTEICO 500CEFEPIME500MGM.J BIOPHARM PVT LTD --L-7 MIDC INDUSTRIAL AREA, DIST . RAIGAD , TALOJA , NAVI MUMBAIINDIAPARENTERAL ORDINARY DRY VIALS1.0X500.0 MG VIAL
1045NDA/MAL/HDP/1999TORRENT PHARAMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.CARBATOL 200CARBAMAZEPINE200MGTORRENT PHARMACEUTICALS LTD-INDRAD-382721, TAL KADI, AHMEDABAD, INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,2.0X5.0X10.0 TABLET BLISTER
1046NDA/MAL/HDP/2000TORRENT PHARAMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.CALCIGARD RETARDNIFEDIPINE(SR)20MGTORRENT PHARMACEUTICALS LTD-INDRAD-382721, TAL KADI, AHMEDABAD, INDIAINDIAORAL SOLID RETARD TABLETS10.0X10.0 TABLET BLISTER
1047NDA/MAL/HDP/3961MEDREICH PLCLABOREX UGANDA LIMITEDBIOFERONMULTI INGREDIENTN/AMEDREICH STERILAB LIMITED-NO. 4/3, AVALAHALI ANJANAPURA POST,OFF KANAKAPWA ROAD, BANGALORE 560062 INDIAINDIAORAL SOLID ORDINARY OTHER CAPSULES1.0X3.0X10.0 CAPSULE BLISTER
1048NDA/MAL/HDP/3963NOVARTIS PHARMA SERVICES INCSURGIPHARM (U) LIMITEDCOARTEM DISPERSIBLE TABLETSARTEMETHER + LUMEFANTRINE20MG + 120MGNOVARTIS URUNLERI TURKEY-YENISEHIR MAHALLESI, IHLARA VADISI SOKAK, NO. 2, TR 34912, PENDIK, INSTANBUL, TURKEY.UNITED STATESORAL SOLID ORDINARY SOLUBLE TABLETS1.0X2.0X6.0 TABLET BLISTER,1.0X30.0X6.0 TABLET BLISTER,1.0X1.0X6.0 TABLET BLISTER,2.0X1.0X24.0 TABLET BLISTER,2.0X1.0X18.0 TABLET BLISTER,1.0X36.0X6.0 TABLET BLISTER
1049NDA/MAL/HDP/3965EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDOROFER SYRUPIRON(II) HYDROXIDE POLYMALTOSE COMPLEX50MG/5MLEMCURE PHARMACEUTICALS LTD -LANE NO.3 PHASE II,SIDCO INDUSTRIAL COMPLEX,BARI-BRAHMANA JAMMU 181 133, INDIAINDIAORAL LIQUID ORDINARY SYRUPS1.0X150.0 ML BOTTLE
1050NDA/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 BLISTER
1051NDA/MAL/HDP/3967AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOCLOX-125CLOXACILLIN125MG/5MLMILAN LABORATORIES -PLOT NOS 63, 67 & 87, JAWAHAR CO-OP. INDUSTRIAL
ESTATE LTD., KAMOTHE, PANVEL (NAVI MUMBAI).
INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE
1052NDA/MAL/HDP/3968CIPLA LTDQUALITY CHEMICALS LTD - HUMANNORLUT-NNORETHISTERONE ACETATE5MGCIPLA LTD-VERNA INDIA ESTATES 403722 GOA INDAINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER
1053NDA/MAL/HDP/3969PHARCO PHARMACEUTICALSWIDE SPECTRUM ENTERPRISES (U) LIMITEDFAWAR FRUIT EFFERVESCENT GRANULESSODIUM CARBONATE + TARTARIC ACID + CITRIC ACID2.8G + 1.33G + 0.82GPHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT.
P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT
EGYPTORAL LIQUID ORDINARY EFFERVESCENT POWDERS/GRANULES1.0X6.5 G SACHET
1054NDA/MAL/HDP/3970LABORATORY AND ALLIED LTDHARLEYS UGANDA LIMITEDLECOTRIMCO-TRIMOXAZOLE480MGLABORATORY & ALLIED LTD--PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, MOMBASA ROAD P.O. BOX 42875, GPO 00100, NAIROBI, KENYAKENYAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
1055NDA/MAL/HDP/3971VIRCHOW HEALTHCARE PVT LTDSURGIPHARM (U) LIMITEDVIRIAXONE-SLCEFTRIAXONE + SULBACTAM1G+500MGVIRCHOW HEALTHCARE PVT LTD,-PLOT NO.130, SILVASSA ROAD, GGID VAPI-396 195, GUJURATINDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0 VIAL CARTON + 10 ML AMPOULE WFI
1056NDA/MAL/HDP/3972CIPLA LTD.QUALITY CHEMICALS LTD - HUMANFERTOMID-50CLOMIPHENE50MGCIPLA LTD-VERNA INDIA ESTATES 403722 GOA INDAINDIAORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER
1057NDA/MAL/HDP/3973IPCA LABORATORIES LIMITEDMEDVIN PHARMA LIMITEDLARITHERARTEMETHER80MG/MLIPCA LABORATORIES LTD,-SEJAVTA,RATLAM 457-002 REG.OFF.48 KANDIVLI IND.ESTATE MUMBAI 400067INDIAPARENTERAL ORDINARY I M AMPOULES1.0X6.0X1.0 ML AMPOULE,1.0X8.0X1.0 ML AMPOULE
1058NDA/MAL/HDP/3974KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMCLOXACLOXACILLIN125MG/5MLKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD-PLOT M 444B STRETCHER ROAD NTINDAUGANDAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS100.0 ML BOTTLE
1059NDA/MAL/HDP/3977CHINOIN PHARMACEUTICALS AND CHEMICAL WORKS, CO. LTDLABOREX UGANDA LIMITEDNO-SPA 40MGDROTAVERINE HYDROCHLORIDE40MGCHINOIN PHARMACEUTICAL AND CHEMICAL WORKS PRIVATE CO.LTD-H-2112, VERESEGYHAZ, LEVAI U.5.HUNGARYHUNGARYORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X2.0X10.0 TABLET BLISTER
1060NDA/MAL/HDP/3980UNEED GLOBAL GROUP LIMITEDABACUS PHARMA (AFRICA) LIMITEDAB-TONE TONICVITAMIN B1 + VITAMIN B2 + VITMAIN B6 + VITAMIN B12 + FOLIC ACID + VITAMIN B5 + CALCIUM GLUCONATE + VITAMIN B3 + IRON + ZINC SULPHATE + COPPER SULPHATE + MANGANESE CHLORIDE + LYSINE HCL + HONEY + MALTMG PER 5ML: 5 + 1 + 1 + 5 + 50 + 2 + 20 + 10 + 10 + 3 + 0.2 + 0.25 + 20 + 100 + 100MAXHEAL PHARMACEUTICALS INDIA LTD-J-7 MIDC, TARAPUR INDUSTRIAL AREA, BOISAR- 401506, DIST.THANE, MARAHASHTRA, INDIAINDIAORAL LIQUID ORDINARY SYRUPS1.0X1.0X200.0 ML BOTTLE,1.0X90.0 ML BOTTLE
1061NDA/MAL/HDP/3981GLAXO SMITH KLINE LTDERIS LTDPENAMOXAMOXYCILLIN500MGMEDREICH STERILAB LTD-12TH MILE, OLD MADRAS ROAD, VIRGONAGOR, BANGALORE 560049, INDIAINDIAORAL SOLID ORDINARY CAPSULES25.0X20.0 CAPSULE BLISTER,10.0X10.0 CAPSULE BLISTER,1.0X500.0 CAPSULE CONTAINER
1062NDA/MAL/HDP/3983UNEED GLOBAL GROUP LIMITEDABACUS PHARMA (AFRICA) LIMITEDEXTRADOLPARACETAMOL/CAFFEINE TABLETS500MG/65MGMAXHEAL PHARMACEUTICALS INDIA LTD-J-7 MIDC, TARAPUR INDUSTRIAL AREA, BOISAR- 401506, DIST.THANE, MARAHASHTRA, INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X50.0X2.0 TABLET BLISTER
1063NDA/MAL/HDP/3985AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOMYCIN SUSPENSIONERYTHROMYCIN ESTOLATE125MG/5MLAGOG PHARMA-PLOT 33 SECTOR THE VASAI-TULUKA CO-OP ESTATE LTD INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X1.0X100.0 ML BOTTLE
1064NDA/MAL/HDP/3987REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDROHISOL SYRUPLEVAMISOLE HYDROCHLORIDE40MG/5MLREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL LIQUID ORDINARY SYRUPS1.0X500.0 ML BOTTLE,1.0X15.0 ML BOTTLE
1065NDA/MAL/HDP/3989UNICHEM LABORATORIES LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDCELIB 200MGCELECOXIB200MGUNICHEM LABORATORIES LTD--PLOT 17 & 18, PILERNE IND. ESTATE, PILERNE, BARDEZ GOA-403511INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER
1066NDA/MAL/HDP/3990REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDUNIXIL SYRUPAMOXYCILLIN TRIHYDRATE125MG/5MLREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X1.0X100.0 ML BOTTLE
1067NDA/MAL/HDP/3991AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOFULVINGRISEOFULVIN TABLETS500MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER
1068NDA/MAL/HDP/3993NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDNEM SCABMULTI-INGREDIENTMULTI-INGREDIENTNEM LABORATORIES PVT LTD-133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAIINDIATOPICAL EXTERNAL OINTMENTS1.0X15.0 G TUBE
1069NDA/MAL/HDP/3996AGOG PHARMA 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 INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
1070NDA/MAL/HDP/3998AGOG PHARMA 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 INDIAINDIAORAL LIQUID ORDINARY SYRUPS1.0X1.0X100.0 ML BOTTLE,1.0X1.0X60.0 ML BOTTLE
1071NDA/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, EGYPTEGYPTORAL LIQUID ORDINARY SYRUPS1.0X125.0 ML BOTTLE
1072NDA/MAL/HDP/4001AGOG PHARMA 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 INDIAINDIAORAL LIQUID ORDINARY SYRUPS1.0X1.0X100.0 ML BOTTLE,1.0X1.0X60.0 ML BOTTLE
1073NDA/MAL/HDP/4002AGOG PHARMA 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 INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE,1.0X170.0 ML BOTTLE
1074NDA/MAL/HDP/4003TATA UGANDA LIMITEDTATA UGANDA LIMITEDOXYTOCIN INJOXYTOCIN10IU/MLGLAND PHARMA LIMITTED 143-148-D P PALLY, QUTHUBULLAPUL MANDAL, RANDA REDDY DIST, HYBERABAD, IN-500 043, INDIAINDIAPARENTERAL ORDINARY AMPOULES1.0 ML AMPOULE
1075NDA/MAL/HDP/4004LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDANTHELALBENDAZOLE400MGLINCOLN PHARMACEUTICALS LTD--TRIMUL ESTATE AFER VODSAR VILLAGE KHATJAT 382 721 GUJARAT VADSAR P.O.J TALUKA KALOH DIST GANDHINAGAR INDIAINDIAORAL SOLID ORDINARY CHEWABLE TABLETS1.0X1.0X1.0 TABLET BLISTER
1076NDA/MAL/HDP/4006SANOFI-AVENTISLABOREX UGANDA LIMITEDRHINATHIOL 5% FOR ADULTS SUGARFREECARBOCISTEINE5G/100MLNATTERMAN & CIE , GMBH NATTERMANNALLEE 1 -,50829 COLOGNE , GERMANYGERMANYORAL LIQUID ORDINARY SYRUPS1.0X200.0 ML BOTTLE
1077NDA/MAL/HDP/4007SANOFI PASTEURLABOREX UGANDA LIMITEDSHANCHOL CHOLERA VACCINEV.CHOLERA STRAINS- 01 INABA FORMALDEHYDE KILLED +01 OGAWA HEAT KILLED + 01 OGAWA FORMALDEHYDE KILLED + 01 INABA HEAT KILLED + 0139 FORMALDEHYDE KILLED600 + 300 +300 +300 + 600 ELISA UNITS(EU) OF LIPOPOLYSACCHARIDE (LPS)SHANTHA BIOTECHNICS LTD -SURVEY NO. 274, ATHVELLI VILLAGE, MEDCHAL MANDAL – 501401, RANGA REDDY DISTRICT, ANDHRA PRADESH, INDIAINDIAPARENTERAL ORDINARY I M VIALS1.0X10.0X1.5 ML VIAL (1 DOSE)
1078NDA/MAL/HDP/4010KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDPYRIPYRIDOXINE HYDROCHLORIDE25MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALAUGANDAORAL SOLID ORDINARY TABLETS1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,1.0X500.0 TABLET CONTAINER,1.0X250.0 TABLET CONTAINER,1.0X10.0 TABLET BLISTER
1079NDA/MAL/HDP/4012ACINO PHARMA AGGOODMAN INTERNATIONAL LTDMESPORIN 2000CEFTRIAXONE2000MGLABESFAL LABORATORIOS ALMIRO, S.A ,.-ZONA INDUSTRIAL DO LABENGO, 3465-157 SANTIAGO DE BESTEIROSPORTUGALPARENTERAL ORDINARY DRY VIALS1.0X1.0X50.0 ML VIAL
1080NDA/MAL/HDP/4014GENO PHARMACEUTICALS PVT LTDHARLEYS UGANDA LIMITEDFUSIGENSODIUM FUSIDATE20MG/GGENO PHARMACEUTICALS LIMITED-KARASWADA,MAPUSAINDIATOPICAL EXTERNAL OINTMENTS1.0X10.0 G TUBE
1081NDA/MAL/HDP/4015CADILA PHARMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.TAMBAC 50CEFPODOXIME PROXETIL50MG/5MLCADILA PHARMACEUTICALS LTD.-1389, TRASAD ROAD, DHOLKA 387810 DISTRICT AHMEDABAD GUJARAT STATEINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X60.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE
1082NDA/MAL/HDP/4016OTSUKA PHARMACEUTICAL INDIA PRIVATE LIMITEDREDDYS PHARMA LIMITEDCOMPOUND SODIUM LACATE INTRAVENOUS INFUSIONMULTI-INGREDIENTMULTI-INGREDIENTOTSUKA PHARMACEUTICAL INDIA PRIVATE LTD-VILLAGE – VASANA – CHACHARWADIP, TAL: SANAND, AHMADABADINDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X500.0 ML BOTTLE
1083NDA/MAL/HDP/4017THE ARAB P'CAL MANUFACTIRING CO.GOODMAN INTERNATIONAL LTDZOCIN CAPSULESAZITHROMYCIN250MGARAB PHARMACEUTICAL MANUFACTURING INDUSTRIES --KING ABDULAH 2ND STREET / INDUSTRIAL AREA BUILDING NO. 1 AL-BUHAIRAH / SULT-JORDANJORDANORAL SOLID ORDINARY CAPSULES1.0X6.0 CAPSULE BLISTER
1084NDA/MAL/HDP/4018MEDREICH PLCLABOREX UGANDA LIMITEDZEBENALBENDAZOLE100MG/5MLMEDREICH LTD-4/3 OFF KANAPURA ROAD, AVALAHALLI, A, TEJKAMAL PHARMACEUTICAL PVT, SURVEY NO.6/2 ALADAHALLI,SOMAPURAHOBIL,NELAMANGALA TALUK,BANGALORE RURAL-562111,INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X20.0 ML BOTTLE
1085NDA/MAL/HDP/4019SEDICO PHARMACEUTICAL CO.WIDE SPECTRUM ENTERPRISES (U) LIMITEDFLUCAMOX 1GAMOXICILLIN + FLUCLOXACILLIN500 MG + 500 MGSEDICO PHARMACEUTICAL CO.-1ST INDUSTRIAL ZONE 6 TH OCTOBER CITY GIZA,EGYPTEGYPTPARENTERAL ORDINARY VIALS1.0X1.0 G VIAL
1086NDA/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 INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X3.0 TABLET BLISTER
1087NDA/MAL/HDP/4022ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDASPI-MCHLORPHENIRAMINE4MGASTRA LIFE CARE(INDIA) PVT LTD-57/P, POJODA, 382220, BOVIA, AHMEDOBAD, INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER
1088NDA/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 BOTTLE
1089NDA/MAL/HDP/4024SEDICO PHARMACEUTICAL CO.WIDE SPECTRUM ENTERPRISES (U) LIMITEDSEDALAC SYRUPLACTULOSE3.350G/5MLSEDICO PHARMACEUTICAL CO.-1ST INDUSTRIAL ZONE 6 TH OCTOBER CITY GIZA,EGYPTEGYPTORAL LIQUID ORDINARY SYRUPS1.0X120.0 ML BOTTLE
1090NDA/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
1091NDA/MAL/HDP/4031SEDICO PHARMACEUTICAL COWIDE SPECTRUM ENTERPRISES (U) LIMITEDSALBUTAMOL SYRUPSALBUTAMOL2MG/5MLSIDECO PHARMACEUTICAL CO LTD- EGYPT-1ST INDUSTRIAL ZONE, 6 OCTOBER CITY- EGYPTEGYPTORAL LIQUID ORDINARY SYRUPS1.0X1.0X120.0 ML BOTTLE
1092NDA/MAL/HDP/4033JOHNSON&JOHNSON PTY LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDBENYLIN PAEDIATRIC SYRUPDIPHENHYDRAMINE HYDROCHLORIDE7MG/5MLJOHNSON&JOHNSON PTY LTD.-EDMS BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICASOUTH AFRICAORAL LIQUID ORDINARY SYRUPS1.0X1.0X100.0 ML BOTTLE
1093NDA/MAL/HDP/4035BAYER SCHERING PHARMASURGIPHARM (U) LIMITEDYASMINDROSPIRENONE + ETHINYLESTRADIOL3MG+0.3MGBAYER PHARMA A.G-MULLERSTRASSE 178, 13353 BERLIN, GERMANYGERMANYORAL SOLID ORDINARY TABLETS1.0X1.0X21.0 TABLET BLISTER
1094NDA/MAL/HDP/4038NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDPREDSONE-5PREDNISOLONE5MGNEM LABORATORIES PVT LTD-133 KRISHNA INDUSTRIAL ESTATE VASAI (E) DIST THANE 401 210 MAHARASHTRAINDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
1095NDA/MAL/HDP/4042SWISS PARENTERALS PVT. LTD.SHREEJI PHARMACEUTICALS LIMITEDS-CHLORCHLORAMPHENICOL1GSWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIAINDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0 G VIAL
1096NDA/MAL/HDP/4043KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAM AMPIAMPICILLIN125MG/MLKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALAUGANDAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE
1097NDA/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, INDIAINDIAORAL 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 BLISTER
1098NDA/MAL/HDP/4052HETERO DRUGS LTDABACUS PHARMA (AFRICA) LIMITEDEFAVIRENZEFAVIRENZ600MGHETERO DRUGS LTD-UNIT-111 NO 22-110 I.D.A JEEDIMETTA HYDRABAD 500055,HETERO LABS LTD. UNIT (V) .-S.N0.439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE), JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X30.0 TABLET CONTAINER
1099NDA/MAL/HDP/4055BAYER PHARMA AGSURGIPHARM (U) LIMITEDBAYER ASPIRIN CARDIOACETYLSALICYLIC ACID100MGBAYER PHARMA AG-D-51368 LEVERKUSEN, GERMANYGERMANYORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X3.0X10.0 TABLET STRIP
1100NDA/MAL/HDP/4057LEBEN LABORATORIES PVT. LTDANDYCO 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 BLISTER
1101NDA/MAL/HDP/4060NORVATIS PHARMA AG- SWITZERLANDLABOREX UGANDA LIMITEDTOBRADEXTOBRAMYCIN/DEXAMETHASONE0.3%W/V+ 0.1%W/VALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUMBELGIUMOPHTHALMIC DROPS1.0X5.0 ML BOTTLE
1102NDA/MAL/HDP/4062GLAXO SMITH KLEINE LIMITEDERIS LTDKIVEXAABACAVIR SULFATE + LAMIVUDINE600 MG + 300 MGGLAXO WELLCOME S.A.-AVENIDA DE EXTREMADURA 3
09400 ARANDA DE DUERO
BURGOS
SPAIN
SPAINORAL SOLID ORDINARY TABLETS1.0X1.0X30.0 TABLET CONTAINER,1.0X3.0X10.0 TABLET BLISTER
1103NDA/MAL/HDP/4064AGOG PHARMA LTD.GITTOES PHARMACEUTICALS LIMITEDTERAFINETERBINAFINE250MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X1.0X14.0 TABLET BLISTER
1104NDA/MAL/HDP/4066UNIVERSAL CORPORATION LTDDELMAW ENTERPRISES LIMITEDUNIBROLAMINOSIDINE125MG/MLUNIVERSAL CORPORATION LTD-KIKUYU NAIROBI KENYAKENYAORAL LIQUID ORDINARY SYRUPS1.0X1.0X60.0 ML BOTTLE
1105NDA/MAL/HDP/4067CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDCATENOL-50 TABLETSATENOLOL50MGCADILA HEALTH CARE LIMITED-KUNDAIM INDUSTRIAL ESTATE, PONDA, GOA-403401, INDIA.
.
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER
1106NDA/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),INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X6.0X15.0 TABLET BLISTER
1107NDA/MAL/HDP/4072SIRMAXO CHEMICALS PVT LTDSUPER MEDIC LTDSANIQUAD M 20CHLORHEXIDINE4%W/VSIRMAXO CHEMICALS-PLOT NO E 35, TARAPUR, BOISAR DIST, MUMBAIINDIATOPICAL EXTERNAL LIQUIDS1.0X500.0 ML BOTTLE,1.0X5.0 L JERRYCAN
1108NDA/MAL/HDP/4079PHARMA INTL CO..OMAB UGANDA LIMITEDNERVAMINEMECOBALAMIN500MCGPHARMA INTERNATIONAL CO.-AMMAN JORDAN PLANT
AL-QARTAL MARKETING DEPARTMENT
ALBUJAH COMPLEX, ALJUBAIHA
JORDANORAL SOLID ORDINARY FILM-COATED TABLETS1.0X30.0 TABLET CONTAINER
1109NDA/MAL/HDP/4082SANOFI AVENTISLABOREX UGANDA LIMITEDNO-SPA FORTEDROTAVERINE HCL80MGCHINOIN PHARMACEITCAULS AND CHEMICAL WORKS CO. LTD-H10-45 BUDAPEST TOU HUNGARY.HUNGARYORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER
1110NDA/MAL/HDP/4084IVEE INFUSIONS EPZ LTDASTRA PHARMA (U) LIMITEDWATER FOR INJECTIONSTERILIZED WATER FOR INJECTIONN/AIVEE INFUSIONS EPZ LTD--LR NO.18474/84,ATHI RIVER BOX 25251 00100 NAIROBI KENYA ATHI RIVER,KENYAKENYAPARENTERAL ORDINARY VIALS1.0X1.0 ML VIAL
1111NDA/MAL/HDP/4085GLAXO WELLCOME (KENYA) LTDERIS LTDZINACEFCEFUROXIME SODIUM750MGGLAXO WELLCOME -VERONA ITALYITALYPARENTERAL ORDINARY DRY VIALS1.0X750.0 MG VIAL
1112NDA/MAL/HDP/4086LEBEN LABORATORIES PVT LTDANDYCO PHARMACY (UGANDA) LTDKELVIN SUSPENSIONPARACETAMOL120MG/5MLLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X60.0 ML BOTTLE
1113NDA/MAL/HDP/4089ELYS CHEMICAL INDUSTRIES LTDVELVET PHARMA LIMITEDCONAZOLKETOCONAZOLE200MGELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBIKENYAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER
1114NDA/MAL/HDP/4092SANDOZ KENYA C/O NOVARTIS PHARMA SERVICES INCPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDFLORANORMSACCHAROMYCES BOULARDII250MGBHARAT BIOTECH INTERNATIONAL LTD-TURKPALLY
SHAMEX
500 078
MYDERAHAD
INDIA
INDIALUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER1.0X2.0X250.0 MG SACHET,1.0X10.0X250.0 MG SACHET
1115NDA/MAL/HDP/4093LEBEN LABORATORIES LTDANDYCO PHARMACY (UGANDA) LTDBECLOMIN OINTMENTBECLOMETHASONE+MICONAZOLE+NEOMYCIN0.025%W/W + 2%W/W + 0.5%W/WLEBEN LAB PVT LTD-L4 PHASE 111 MIDCS AKOLA 444104 MAHARASTRA INDIAINDIATOPICAL EXTERNAL OINTMENTS1.0X15.0 G TUBE
1116NDA/MAL/HDP/4095LEBEN LABORATORIES PVT LTDANDYCO PHARMACY (UGANDA) LTDIBUT-200IBUPROFEN200MGLEBEN LAB PVT LTD-L4 PHASE 111 MIDCS AKOLA 444104 MAHARASTRA INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER
1117NDA/MAL/HDP/4097GLAXOSMITHKLINE LTD UKERIS LTDDERMOVATECLOBETASOL PROPIONATE0.05%W/WGLAXOSMITHKLINE HARMIRE -GLAXOSMITHKLINE HARMIRE ROAD BARNARD CASTLE DURHAMUNITED KINGDOMTOPICAL EXTERNAL CREAMS1.0X25.0 G TUBE,1.0X30.0 G TUBE
1118NDA/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, GUJARATINDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X100.0 ML BOTTLE
1119NDA/MAL/HDP/4100REMEDICA LTDGOODMAN INTERNATIONAL LTDNORETHISTERONENORETHISTERONE5MGREMEDICA LIMITED -AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUSCYPRUSORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER
1120NDA/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 BLISTER
1121NDA/MAL/HDP/4102TORRENT PHARMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.AZULIX-2GLIMEPIRIDE2MGTORRENT PHARMACEUTICALS LTD-INDRAD-382721, TAL KADI, AHMEDABAD, INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER
1122NDA/MAL/HDP/4103GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDPOLIO SABIN - ONE AND THREE [ORAL]LIVE ATTENUATED POLIOMYELITIS VIRUS VACCINE OF THE SABIN STRAINS TYPE 1 +TYPE 210?CCID??+10?.?CCID??GLAXO SMITHKLINE BIOLOGICALS S.A-RUE DE L'INSTITUT, 89 B-1330 RIXENSARTBELGIUMPARENTERAL ORDINARY I M VIALS1.0X100.0X2.0 ML VIAL (20 DOSES)
1123NDA/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 BLISTER
1124NDA/MAL/HDP/4107ABBOTT HEALTHCARE , SASHARLEYS UGANDA LIMITEDDUSPATALIN 200 MGMEBEVERINE200MGSOLVY PHARMACEUTICALS LTD-VEERWEG 12 NL 8121 NETHERLANDSNETHERLANDSORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 TABLET BLISTER
1125NDA/MAL/HDP/4109CIPLA LTD.QUALITY CHEMICALS LTD - HUMANCIPLIN DSSULFAMETHOXAZOLE + TRIMETHOPRIM800MG + 160MGCIPLA LIMITED -PLOT NO A – 33, A – 2 (UNIT – I),
MIDC PATALGANGA,
DISTRICT RAIGAD, 410 220
MAHARASHTRA, INDIA
INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER
1126NDA/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
1127NDA/MAL/HDP/4113MICRO LABS LTDLABOREX UGANDA LIMITEDEROSTIN 10EBASTINE10 MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIAINDIAORAL SOLID ORDINARY TABLETS10.0X10.0 TABLET BLISTER
1128NDA/MAL/HDP/4114REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDRINALIN SYRUPCHLORPHENIRAMINE MALEATE2MG/5MLREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL LIQUID ORDINARY SYRUPS1.0X60.0 ML BOTTLE
1129NDA/MAL/HDP/4115REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDPREDILONEPREDNISOLONE5.0 MGREGAL PHARMACEUICALS LTD-PLOT NO 7879 OFF BABA DOGO ROAD KUARAKA NAIROBIKENYAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER
1130NDA/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 INDIAINDIAOPHTHALMIC DROPS1.0X10.0 ML VIAL
1131NDA/MAL/HDP/4121AVENTIS PHARMA (PTY) LTD SOUTH AFRICALABOREX UGANDA LIMITEDRIFINAH 300RIFAMPICIN + ISONIAZID300MG + 150MGAVENTIS PHARMA-AVENTIS PHARMA, 315 WALTLOO ROAD, SILVERTON 0127 PRETORIASOUTH AFRICAORAL SOLID ORDINARY TABLETS1.0X20.0 TABLET BLISTER
1132NDA/MAL/HDP/4123HETERO LABS LTD UNIT VIABACUS PHARMA (AFRICA) LIMITEDNEVIRAPINENEVIRAPINE200MGHETERO LABS LTD (UNIT-V)-SEZ JADCHERIA HYDRABAD,HETERO LABS LIMITED .-UNIT 111, H22-110, I.D.A, JEEDIMETLA, HYDERABAD, 500055INDIAORAL SOLID ORDINARY TABLETS1.0X60.0 TABLET CONTAINER
1133NDA/MAL/HDP/4126UNICHEM LABORATORIES LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDCELIB 100MGCELECOXIB100MGUNICHEM LABORATORIES LTD--PLOT 17 & 18, PILERNE IND. ESTATE, PILERNE, BARDEZ GOA-403511INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER
1134NDA/MAL/HDP/4127SANOFI AVENTS FRANCELABOREX UGANDA LIMITEDEPILIMSODIUM VALPROATE200MG/5MLUNITHER LIQUID MANUFACTURING INDUSTRIE -COLOMIERS 1-3 ALLE DE LA NESTE L DEN SIGAL 31770FRANCEORAL LIQUID ORDINARY SYRUPS1.0X200.0 ML BOTTLE,1.0X300.0 ML BOTTLE
1135NDA/MAL/HDP/4128RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDVITAREN SYRUPVITAMIN A + VITAMIN B2 + VITAMIN B1 + VITAMIN B6 + VITAMIN C + VITAMIN E + VITAMIN B31500IU/5ML + 1MG/5ML + 1MG/5ML + 0.5MG/5ML + 20MG/5ML + 100 IU/5ML + 10MG/5MLRENE INDUSTRIES LIMITED-PLOT 680 KAMULI- KIREKAUGANDAORAL LIQUID ORDINARY SYRUPS1.0X1.0X60.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE
1136NDA/MAL/HDP/4130WOCKHARDT LTDSTAR PHARMACEUTICALS LTDKEFSTAR-250CEFUROXIME AXETIL250MGSANCE LABORATORIES PVT. LTD.-VI/B, P.B. NO. 2, KOZHUVANAL, PALA, KOTTAYAM DISTRICT-686573, KERALA,
INDIA.
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X4.0 TABLET STRIP, 1.0X10.0 TABLET BLISTER
1137NDA/MAL/HDP/4132CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDZYCEL 200CELECOXIB200MGCADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIAINDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER
1138NDA/MAL/HDP/4133ELYS CHEMICAL INDUSTRIES LTDVELVET PHARMA LIMITEDELYCETINCHLORAMPHENICOL125MG/MLELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBIKENYAORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE,1.0X5.0 L JERRYCAN
1139NDA/MAL/HDP/4134INDOCO REMEDIES LTDTATA UGANDA LIMITEDCITALDISODIUM HYDROGEN CITRATE1.37G/5MLINDOCO REMEDIES LTD-B-20, MIDC, WALUJ, AURANGABAB 431136 INDIAINDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE
1140NDA/MAL/HDP/4138ELYS CHEMICAL INDUSTRIES LTDVELVET PHARMA LIMITEDELYCLOX CAPSULESAMPICILLIN + CLOXACILLIN250 MG + 250 MGELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBIKENYAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X500.0 CAPSULE CONTAINER
1141NDA/MAL/HDP/4140ROTEX MEDICA GBH ARZNEIMITTELIGITTOES PHARMACEUTICALS LIMITEDDIAZEPAM INJECTIONDIAZEPAM10MG/2MLROTEXMEDICA GMBH ARZEIMITTEL WERK-BUNSENSTRASSE 4, 22946 TRITTAUGERMANYPARENTERAL ORDINARY AMPOULES1.0X10.0X2.0 ML AMPOULE
1142NDA/MAL/HDP/4141SANOFI WINTHROP A.M.OLABOREX UGANDA LIMITEDEPILIM 200SODIUM VALPROATE200MG FISONS LTD (ALSO KNOWN AS SANOFI-AVENTIS)-RIELL, SPAINSPAINORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER
1143NDA/MAL/HDP/4142DAFRA PHARMA LTDLABOREX UGANDA LIMITEDCO-ARTESAINEARTEMETHER + LUMEFANTRINE360MG + 2160MGMPF BV-APPLEHOF 13; NI 8465 RX OUDEHASKE
NETHERLANDS
NETHERLANDSORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X120.0 ML BOTTLE
1144NDA/MAL/HDP/4143MODI NUNDIPHARMA PVT LTDSURGIPHARM (U) LIMITEDTAM CONTIN 0.4TAMSULOSIN HYDROCHLORIDE0.4MGMODI MUNDIPHARMA PVT. LTD-MEERUT-MUZAFFARNAGAR ROAD, MODIPURAM – 250110 UTTAR PRADESHINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET STRIP
1145NDA/MAL/HDP/4146AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOMPICLOXAMPICILLIN + CLOXACILLIN250 MG + 250 MGMILAN LABORATORIES (INDIA ) PVT LTD-PLOT NO.63-67 & 87,JAWAHAR CO.OP.INDUSTRIAL ESTATE LTD KAMOTHE,PANVEL DIST. THANE,MAHARASTRA-410209,INDIAINDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER
1146NDA/MAL/HDP/4147ERIS LTDBENLE CONSULT LIMITEDNIFEDI-DENK 20 RETARDNIFEDIPINE20MGDENK PHARMA GMBH &CO.KG-PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529GERMANYORAL SOLID RETARD FILM-COATED TABLETS1.0X10.0X10.0 TABLET STRIP
1147NDA/MAL/HDP/4148COSMOS LIMITEDASTRA PHARMA (U) LIMITEDAMITRIPTYLINE TABLETSAMITRIPTYLINE25MGCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBIKENYAORAL SOLID ORDINARY TABLETS10.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER
1148NDA/MAL/HDP/4149GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDTRACRIUM INJECTIONATRACURIUM BESYLATE10MG/MLGLAXO SMITHKLINE MANUFACTURING S.P.A .-STARDA PROVINCIALE ASOLANA 90, 43056 SAN POLO DI TORRILE (PARMA),GLAXOSMITHKLINE SPA FLEMING -2, 37135 PARMAITALYPARENTERAL ORDINARY AMPOULES1.0X2.5 ML AMPOULE,1.0X5.0 ML AMPOULE,1.0X10.0 ML AMPOULE
1149NDA/MAL/HDP/4150TORRENT PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.ANGIOPRIL-25CAPTOPRIL25MGTORRENT PHARMACEUTICALS LTD-INDRAD-382 721, DIST.MEHSANA,INDIA.AT:VILL.MANAKPUR,TEH.NALAGARH,DIST.SOLAN(H.P.)INDIAORAL SOLID ORDINARY TABLETS10.0X10.0 TABLET BLISTER
1150NDA/MAL/HDP/4153TATA UGANDA LIMITEDTATA UGANDA LIMITEDDIAZEPAM INJECTIONDIAZEPAM5MG/MLGLAND PHARMA LTD.-GLAND PHARMA LTD, D.P. PALLY, SURVEY NO. 143,150 &INDIAPARENTERAL ORDINARY AMPOULES1.0X10.0X2.0 ML AMPOULE
1151NDA/MAL/HDP/4165CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDZEFONE INJECTIONCEFTRIAXONE SODIUM1GSAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIA,REYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG PROVINCE P.R. 256100,INJECTCARE PARENTERALS PVT. LTD.-PLOT130 SILVASSA ROAD GIDC VAPI 396195 GUJARAT,ZEISS PHARMACEUTICALS PVT LTD-72 EXPORT PROMOTION INDUSTRIAL PARK ,PHASE-1,JHARMAJRI, BADDI DIST:SOLAN H.P INDIAINDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0 G VIAL
1152NDA/MAL/HDP/4169CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDFLUCOZYD-200FLUCONAZOLE200MGCADILA HEALTH CARE LTD-SARKHEJ BAVLA N.H NO. 8A MORAIJA, TAL, SANARD, AHMEDAD 382210, INDIAINDIAORAL SOLID ORDINARY CAPSULES1.0X4.0X7.0 CAPSULE BLISTER
1153NDA/MAL/HDP/4170CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDTRAMAZACTRAMADOL HYDROCHLORIDE50MGCADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIAINDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER
1154NDA/MAL/HDP/4171MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDTOREXMULTIINGREDIENTN/ATORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER
1155NDA/MAL/HDP/4172RENE INDUSTRIESRENE INDUSTRIES LIMITEDKOF OFF EXPECTORANTMULTI-INGREDIENTMULTI-INGREDIENTRENE INDUSTRIES-PLOT 680 KAMULI KIREKAUGANDAORAL LIQUID ORDINARY SYRUPS1.0X110.0 ML BOTTLE
1156NDA/MAL/HDP/4173MSD (PTY) LIMITED SAPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDNASONEXMOMETASONE FUROATE MONOHYDRATE0.05%W/VMSD PTY LTD-117 16TH ROAD, HALFWAY HOUSE 1685,SCHERING PLOUGH LABO N.V,-INDUSTRY PARK 30, 2220 HEIST OPDENBERG BELGIUMBELGIUMNASAL SYSTEMIC METERED-DOSE LIQUIDS1.0X1.0X120.0 METERED DOSE CANNISTER
1157NDA/MAL/HDP/4180WIN-MEDICARE PVT LTDSURGIPHARM (U) LIMITEDOSMOWINLACTULOSE10G/15MLG.S PHAMBUTOR PVT LTD-G.S PHAMBUTOR PVT LTD B-172 RIICO IND ,BEHOR 301701 DIST ALWAR RAJASTHAN INDIAINDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE
1158NDA/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 STRIP
1159NDA/MAL/HDP/4183GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDCHLORPROMAZINECHLORPROMAZINE25MG/MLNINGBO DAHONGYING PHARMACEUTICAL CO LTD-NO 396, MINGZHU ROAD NINGBO CITY CHINACHINAPARENTERAL ORDINARY AMPOULES1.0X10.0X2.0 ML AMPOULE
1160NDA/MAL/HDP/4187BAYER PHARMA AGSURGIPHARM (U) LIMITEDNORIGYNONESTRADIOL VALERATE +NORETHINDRONE ENANTHATE5 MG+50 MG / MLBAYER PHARMA A.G-MULLERSTRASSE 178, 13353 BERLIN, GERMANYGERMANYPARENTERAL ORDINARY AMPOULES1.0X1.0 ML AMPOULE
1161NDA/MAL/HDP/4188AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOPRAZPRAZIQUANTEL600MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X2.0X4.0 TABLET BLISTER,1.0X1.0X4.0 TABLET BLISTER
1162NDA/MAL/HDP/4276SWISS PARENTERALS PVT. LTD.SHREEJI PHARMACEUTICALS LIMITEDFALCI CAREARTESUNATE60MGSWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIAINDIAPARENTERAL ORDINARY DRY VIALS1.0X60.0 MG VIAL + 5 ML NACL + 1 ML SODIUM BICARBONATE
1163NDA/MAL/HDP/4277NABIQASIM INDUSTRIES (PVT) LIMITEDJEET PHARMACEUTICALS LIMITEDVIVIRON PLUS SYRUPFERRIC AMMONIUM CITRATE +FOLIC ACID + PYRIDOXINE HCL + THIAMINE HCL + NICOTINAMIDE50MG + 0.5MG + 2.2MG + 1.3MG +11MGNABIQASIM INDUSTRIES (PVT) LTD--17/24,KORANGI INDUSTRIAL AREA, KORANGI, KARACHI- PAKISTAN.PAKISTANORAL LIQUID ORDINARY SYRUPS1.0X90.0 ML BOTTLE,1.0X250.0 ML BOTTLE
1164NDA/MAL/HDP/4279AUROLABSWASTIK PHARMACEUTICAL LTDAUROTIMTIMOLOL MALEATE0.5% W/VAUROLAB-NO. 1, SIVAGANGAI MAIN ROAD, VEERAPANJAN, MADURAIINDIAOPHTHALMIC DROPS1.0X5.0 ML BOTTLE
1165NDA/MAL/HDP/4286ZEE PHARMACEUTICALS LTDZEE PHARMACEUTICALS LIMITEDZEEGRA-50SILDENAFIL CITRATE50MGTHE MADRAS PHARMACEUTICALS-137-B,OLD MAHABALI PURAM ROAD,KARAPAKKAM,CHENNAL INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X4.0 TABLET BLISTER
1166NDA/MAL/HDP/4288SANDOZ KENYA C/O NOVARTIS PHARMA SERVICES INCSURGIPHARM (U) LIMITEDCOLESTOPATORVASTATIN10MGLEK PHARMACEUTICALS-D.D VEROVŠKOVA 57, 1526 LJUBLJANA SLOVENIASLOVENIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER
1167NDA/MAL/HDP/4289GLAXOSMITHKLINE LTDERIS LTDTWINRIX ADULTINACTIVATED HEPATITIS A ANTIGEN + HEPATITIS B SURFACE ANTIGEN720 ELISA UNITS + 20MCGGLAXOSMITHKLINE BOILOGICALS-S.A RUE DE I'INSTITUT 89 B-1330 RIXENSARTBELGIUMPARENTERAL ORDINARY VIALS1.0X1.0 ML VIAL (1 DOSE)
1168NDA/MAL/HDP/4290CIPLA LTD.QUALITY CHEMICALS LTD - HUMANCIPLINSULFAMETHOXAZOLE/TRIMETHOPRIM400MG/80MGCIPLA LTD-UNIT I & II A-32 & A-42 MIDC PATALGANGA 410220 DIST-RAIGAD, MAHARASHTRA INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER, 1.0X100.0 TABLET CONTAINER, 1.0X10.0X10.0 TABLET BLISTER
1169NDA/MAL/HDP/4291GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDVITAMIN B COMPLEX INJECTIONVITAMIN B COMPLEX10MG/2MLNINGBO DAHONGYING PHARMACEUTICALS LTD- NO. 396 MINCHINAPARENTERAL ORDINARY AMPOULES1.0X10.0X2.0 ML AMPOULE
1170NDA/MAL/HDP/4292F. HOFFMANN LA-ROCHELABOREX UGANDA LIMITEDHERCEPTIN 150MGTRASTUZUMAB150MGROCHE DIAGNOSTICS GMBH MANNHEIM--SANDHOFER STRASSE 116 -68305 MANNHEIM GERMANY.SWITZERLANDPARENTERAL ORDINARY DRY VIALS1.0X1.0 VIAL CARTON
1171NDA/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 INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER
1172NDA/MAL/HDP/4297INDOCO REMEDIES LIMITEDTATA UGANDA LIMITEDCLOBEN-GCLOTRIMAZOLE/BECLOMETHASONE/GENTAMYCIN1%W/W+0.025%W/W+0.1%W/WINDOCO REMEDIES LIMITED-L-14 VERNA INDUSTRIAL AREA VERNAINDIATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE
1173NDA/MAL/HDP/4298SANDOZ GMBH, KENYA C/O NORVATIS PHARMA SERVICES INCSURGIPHARM (U) LIMITEDCOLESTOPATORVASTATIN40MGLEK PHARMACEUTICALS-D.D VEROVŠKOVA 57, 1526 LJUBLJANA SLOVENIASLOVENIAORAL SOLID ORDINARY FILM-COATED TABLETS3.0X10.0 TABLET BLISTER
1174NDA/MAL/HDP/4303PFIZER LABORATORIES (PTY)LABOREX UGANDA LIMITEDSAYANA PRESSMEDROXYPROGESTERONE ACETATE104MG/0.65MLPFIZER MANUFACTURING -NV/NA, RIJKSWEG 12 2870, PUURSBELGIUMPARENTERAL ORDINARY I M PRE-FILLED SYRINGES1.0X200.0X0.65 ML PRE- FILLED SYRINGE
1175NDA/MAL/HDP/4309HETERO DRUGS LTDABACUS PHARMA (AFRICA) LIMITEDLAMIVUDINE + ZIDOVUDINELAMIVUDINE + ZIDOVUDINE150MG + 300MGHETERO LABS LTD (UNIT-V)-SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIA,HETERO LABS LTD-22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESHINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X60.0 TABLET BOTTLE
1176NDA/MAL/HDP/4310GLAXOSMITHLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDACTIFED SYRUPTRIPLORIDINE HCL/PSEUDOEPHEDRINE1.25MG/30MGGLAXO WELLCOME EGYPT SAE.-EL SALAM CITY 11491, CAIROEGYPTORAL LIQUID ORDINARY SYRUPS1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE,1.0X2.0 L JERRYCAN
1177NDA/MAL/HDP/4312MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDGONAL-FFOLLITROPIN ALFA75IU/IEMERCK SERONO S.P.A-VIA DELLE MAGNOLIE,15.70026 MODUGNO (BA).ITALY,MERCK SERONO S.A. (MSA) -1170 SUCCURSALE D’AUBONNE ZONE INDUSTRIELLE DE L’OURIETTAZ, SWITZERLANDSWITZERLANDPARENTERAL ORDINARY DRY VIALS1.0X1.0 VIAL CARTON + 1 PRE FILLED SYRINGE OF WFI
1178NDA/MAL/HDP/4315DENK PHARMA GMB H &CO. KGBENLE CONSULT LIMITEDDESLORA-DENK 5DESLORATIDINE5MGDENK PHARMA GMBH & CO.KG -GOLLSTR 1,84529 TITTMONING GERMANYGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER
1179NDA/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 GERMANYGERMANYORAL SOLID ORDINARY TABLETS1.0X1.0X14.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER
1180NDA/MAL/HDP/4320STRIDES ARCOLAB LIMITEDROYAL PHARMA 2011 LIMITEDHYOSCINE BUTYL BROMIDEHYOSCINE BUTYL BROMIDE10MGSTRIDES ARCOLAB LIMITED-DEWAN & SONS IND. AREA,VEOOR, PALGHAR, MAHARASTRAINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
1181NDA/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 SPAINSPAINOPHTHALMIC DROPS1.0X5.0 ML VIAL
1182NDA/MAL/HDP/4324MSN LABORATORIES LTDPLANET PHARMACEUTICALS UGANDA LTDPRASUSAFE 5PRASUGREL5MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER
1183NDA/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 BLISTER
1184NDA/MAL/HDP/4326NORVATIS PHARMA AG- SWITZERLANDLABOREX UGANDA LIMITEDCUSICROM 4% EYE DROPSSODIUM CROMOGLYCATE4 %W/VALCON CUSI S.A .-CAMIL FABRA,58 08320 EL MASNOU BARCELONA SPAINSPAINOPHTHALMIC DROPS1.0X10.0 ML VIAL
1185NDA/MAL/HDP/4329AGOG PHARMA 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 INDIAINDIAORAL LIQUID ORDINARY SYRUPS1.0X1.0X100.0 ML BOTTLE,1.0X1.0X60.0 ML BOTTLE
1186NDA/MAL/HDP/4330SPARSH BIO-TECH PVT. LTDABACUS PHARMA (AFRICA) LIMITEDFLUCLOXACILLIN CAPSULESFLUCLOXACILLIN250MGSPARSH BIO-TECH PVT. LTD.--PLOT NO. 1, SURVEY NO. 242/243/244, VILLAGE LAKHABAVAD POST KHODIYAR COLONY DISTRICT, JAMNAGAR – 361006 GUJARAT INDIAINDIAORAL SOLID ORDINARY CAPSULES1.0X10.0 CAPSULE STRIP
1187NDA/MAL/HDP/4331STEDMAN PHARMACEUTICALS PVT. LTDVEERAM HEALTHCARE (U) LIMITEDSTEDNACACECLOFENAC100MGSTEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER
1188NDA/MAL/HDP/4333ZEE PHARMACEUTICALS LTDZEE PHARMACEUTICALS LIMITEDCARVIBERGCARVEDILOL USP6.25MGTHE MADRAS PHARMACEUTICALS-137-B,OLD MAHABALI PURAM ROAD,KARAPAKKAM,CHENNAL INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER
1189NDA/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 BLISTER
1190NDA/MAL/HDP/4335DAWA LIMITEDSUPER MEDIC LTDCURAMOL SUSPENSIONPARACETAMOL120MG/5MLDAWA LTD-BABA DOGO ROAD RUARAKAKENYAORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE
1191NDA/MAL/HDP/4338MISSION PHARMAJOINT MEDICAL STORE (UPMB - UCMB)ALBENDAZOLEALBENDAZOLE400MGMEDICAMEN BIOTECH LTD-SP-1192, A &B, PHASE –IV,
INDUSTRIAL AREA BHIWADI -301019 DIST. ALWAR (RAJASTHAN)
INDIAORAL SOLID ORDINARY TABLETS1.0X500.0 TABLET CONTAINER
1192NDA/MAL/HDP/4339GLAXOSMITHKLINE LIMITEDERIS LTDSERETIDE 125 EVOHALERSALMETEROL XINAFOATE + FLUTICASONE PROPIONATE25MCG/125MCGGLAXO WELLCOME PRODUCTION-ZONE INDUSTRIELLE NO.2
23 RUE LAVOISER 27000 EVREUX
FRANCELUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER1.0X120.0 METERED DOSE CANNISTER
1193NDA/MAL/HDP/4340ASTRA PHARMA (U) LTDASTRA PHARMA (U) LIMITEDVITAMIN B COMPLEXVITAMIN B1 + VITAMIN B2 + SODIUM NICOTINAMIDE + VITAMIN B6 + D-PANTHENOL SODIUM10MG + 1.37MG + 15MG + 1MG + 0.5MGZHEJIANG RUIXIN PHARMACEUTICAL CO., LTD--KAITEE ROAD, TIANNING INDUSTRIAL ZONE, LISHUI, ZHEJIANG, P.R.CHINACHINAPARENTERAL ORDINARY AMPOULES1.0X10.0X2.0 ML AMPOULE,1.0X10.0X10.0X2.0 ML AMPOULE
1194NDA/MAL/HDP/4343PASTEUR MERIEUX CONNANGHTLABOREX UGANDA LIMITEDEUVAX B (PAEDIATRIC)HEPATITIS B VACCINE, RECOMBINANT20MCG/MLLG LIFE SCIENCES LTD- 601, YONGJEI-DONG, IKSAN, JESOUTH KOREAPARENTERAL ORDINARY I M VIALS1.0X0.5 ML VIAL (1 DOSE)
1195NDA/MAL/HDP/4344TORRENT PHARMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.LISTRIL-10LISINOPRIL10MGTORRENT PHARMACEUTICAL LTD-AHMEDABAD-MEHSANA HIGHWAY,TALUKA-KADI,DIST.MEHSANA,INDRAD-382721INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER
1196NDA/MAL/HDP/4347GENO PHARMACEUTICALS PVT LTDHARLEYS UGANDA LIMITEDVERTIGONCINNARIZINE25MGGENO PHARMACEUTICALS LTD. -TIVIM INDUSTRIAL ESTATE, KARASWADA, MAPUSA, GOAINDIAORAL SOLID ORDINARY TABLETS1.0X4.0X5.0X10.0 TABLET BLISTER
1197NDA/MAL/HDP/4348REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDMEDICLOAMP SYRUPCLOXACILLIN+AMPICILLIN250MG/5MLREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE
1198NDA/MAL/HDP/4350ACINO PHARMA AGGOODMAN INTERNATIONAL LTDOLFEN-75DICLOFENAC SODIUM75MG/2MLMERCKLE GMBH,-LUDWIG MERCKLE STRASSE3 D-89143 BLAUBEURENGERMANYPARENTERAL ORDINARY AMPOULES1.0X5.0X2.0 ML AMPOULE
1199NDA/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 BOTTLE
1200NDA/MAL/HDP/4352RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDREQUIN SYRUPQUININE HYDROCHLORIDE100MG/5MLRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE
1201NDA/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 TUBE
1202NDA/MAL/HDP/4360ASTRAZENECAMACNAUGHTON LIMITEDZESTRILLISINOPRIL5MGASTRAZENECA PHARMACEUTICALS LP -HUANGSHAN ROAD, WUXI 214028, JIANGSU, CHINA.,ASTRAZENECA MACCLESFIELD-UNITED KINGDOMUNITED KINGDOMORAL SOLID ORDINARY TABLETS1.0X14.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER
1203NDA/MAL/HDP/4361: ALKEM LABORATORIES LIMITED?ABACUS PHARMA (AFRICA) LIMITEDTAXIM-OCEFIXIME200MGALKEM LABORATORIES LIMITED.-VILLAGE THANA, BADDI, TEHSIL-NALAGARH, DISTT-SOLAN, (HP), INDIA-173205INDIAORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER
1204NDA/MAL/HDP/4362MACLEODS PHARMACEUTICAL LTDNORVIK ENTERPRISES LIMITEDLEVOMAC 750LEVOFLOXACIN HEMIHYDRATE750MGMACLEODS PHARMACEUTICALS LIMITED -BLOCK-N2 VILLAGE THEDA POST OFFICE LODHIMAJRA
TEHSIL BADDI DISTRICT SOLAN HIMACHAL PRADESH – 174101
INDIA
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER
1205NDA/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, INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER
1206NDA/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 BLISTER
1207NDA/MAL/HDP/4366SPARSH BIO-TECH PVT LTDABACUS PHARMA (AFRICA) LIMITEDCLOXISPACLOXACILLIN250MGSPARSH BIO-TECH LTD-PLOT NO.1 SURVEY NO.242/234/244, VILLAGE LAKHABARAD, JAMNAGAR-361006INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER,1.0X100.0X10.0 CAPSULE BLISTER
1208NDA/MAL/HDP/4367ASTRA ZENECAMACNAUGHTON LIMITEDATACAND 8MGCANDESARTAN8MGASTRA ZENECA AB, SODERTALJE-GARTUNAYEGEN, SODERTALJESWEDENORAL SOLID ORDINARY TABLETS1.0X2.0X14.0 TABLET BLISTER
1209NDA/MAL/HDP/4369KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDFLUCAPCHLORPHENAMINE MALEATE+PSEUDOEPHEDRINE HYDROCHLORIDE+PARACETAMOL1.25MG+10MG+120MGTIL HEALTH CARE-PLOT 100,WEST,R-5,SOUTH;SRICITY SEZ,CHERIVI,IRUHULAM,PSOT,SATYAVEDU MANDAL,CHITOOR DISTRICT-ANDRA PRADESH-517588, INDIAINDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE
1210NDA/MAL/HDP/4370UNOSOURCE PHARMA LTDABACUS PHARMA (AFRICA) 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 VIAL
1211NDA/MAL/HDP/4371MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDNEVIHOPE 200NEVIRAPINE200MGMACLEODS PHARMACEUTICALS LTD.-PLOT NO. 25-27 SURVEY NO. 366,
PREMIER INDUSTRIAL ESTATE, KACHIGAM,
DAMAN (UT) - 396210, INDIA.
INDIAORAL SOLID ORDINARY TABLETS1.0X60.0 TABLET BOTTLE
1212NDA/MAL/HDP/4373ZEE PHARMACEUTICALS LTDZEE PHARMACEUTICALS LIMITEDAZIBERGAZITHROMYCIN DIHYDRATE500MGTHE MADRAS PHARMACEUTICALS-137-B,OLD MAHABALI PURAM ROAD,KARAPAKKAM,CHENNAL INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0 TABLET BLISTER
1213NDA/MAL/HDP/4375PFIZER LABORATORIES PTY LTDLABOREX UGANDA LIMITEDZITHROMAXAZITHROMYCIN DIHYDRATE200MG/5MLHAUPT PHARMA LATINA S.R.L LATINA-SS 156KM 47,600-04100,BORGO SAN,MICHELE, PFIZER LABORATORIES (PTY) LTD;--SOUTH AFRICAITALYORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X30.0 ML BOTTLE,1.0X15.0 ML BOTTLE
1214NDA/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 CONTAINER
1215NDA/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 CONTAINER
1216NDA/MAL/HDP/4381LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDDICLOFENAC SODIUMDICLOFENAC SODIUM50MGLINCOLN PHARMACEUTICALS LTD-10, 11, 13, TRIMUL ESTATE KHATRAJ, NEAR KHATRAJ, CHOKADI , KHATRAJ-382721, GHANDINAGAR GUJARAT, INDIA
INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS10.0X10.0 TABLET BLISTER
1217NDA/MAL/HDP/4383ZEE PHARMACEUTICALS LTDZEE PHARMACEUTICALS LIMITEDZEEMYCIN - 150CLINDAMYCIN HYDROCHLORIDE BP150MGTHE MADRAS PHARMACEUTICALS-137-B,OLD MAHABALI PURAM ROAD,KARAPAKKAM,CHENNAL INDIAINDIAORAL SOLID ORDINARY OTHER CAPSULES1.0X10.0X10.0 CAPSULE BLISTER
1218NDA/MAL/HDP/4388SWISS PARENTERALS PVT LTDSHREEJI PHARMACEUTICALS LIMITEDTAZOBAKPIPERACILLIN SODIUM + TAZOBACTAM SODIUM4.0G + 0.5GSWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIAINDIAPARENTERAL ORDINARY DRY VIALS1.0X4.5 G VIAL
1219NDA/MAL/HDP/4389PHARMACARE LTDMEDICAL ACCESS (UGANDA) LIMITEDPREZISTADARUNAVIR600MGJANSSEN ORTHO LLC.--STATE ROAD 933 KM 0.1 MARNEY WARD GURABO PUERTO RICO 00778UNITED STATESORAL SOLID ORDINARY TABLETS1.0X60.0 TABLET CONTAINER
1220NDA/MAL/HDP/4390AUROLABSWASTIK PHARMACEUTICAL LTDAUROCOLCHLORAMPHENICOL0.5%W/VAUROLAB-NO 1 SIVAGANGAI MAIN ROAD, VEERAPANJAN MADURAI – 625 020 TAMIL NADU, INDIAINDIAOPHTHALMIC DROPS1.0X10.0 ML BOTTLE
1221NDA/MAL/HDP/4391LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDMOBYLE-AACECLOFENAC + PARACETAMOL100 MG + 325 MGLINCOLN PHARMACEUTICALS LTD-TRIMUL ESTATE AT & POST KHATRAJ TAL KALOL DIST GANDHINAGAR GUJARATINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER
1222NDA/MAL/HDP/4392IND SWIFT LTDPLANET PHARMACEUTICALS UGANDA LTDCAPLORCLOPIDOGREL75MGIND SWIFT LTD-GBU JAWAHARPUR OFF NH-21 DERABASSI DIST MOHALIINDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER
1223NDA/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 BOTTLE
1224NDA/MAL/HDP/4399FOURTS(INDIA) LABORATORIES PVT LTDDELMAW ENTERPRISES LIMITEDGEFILCOMPOUND MAGNESIUM TRISILICATEALUMINIUM HYDROXIDE & MAGNESIUM TRISILICATE 132 &FOURTS (INDIA) LABORATORIES PRIVATE LIMITED -VANDALUR ROADCHINAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER
1225NDA/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 AREAKENYAORAL LIQUID ORDINARY SOLUBLE POWDERS1.0X100.0X20.6 G SACHET,1.0X100.0X10.3 G SACHET
1226NDA/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 AMPOULES
1227NDA/MAL/HDP/4402VIRBAC RSA (PTY) LTDMETRO PHARMACEUTICALS LIMITEDCLOTRILINCLOTRIMAZOLE100MGLINCOLN PHARMACEUTICALS LTD-10, 11, 13, TRIMUL ESTATE KHATRAJ, NEAR KHATRAJ, CHOKADI , KHATRAJ-382721, GHANDINAGAR GUJARAT, INDIA
INDIAVAGINAL TABLETS1.0X6.0 TABLET STRIP
1228NDA/MAL/HDP/4404BHARAT SERUMS AND VACCINES LIMITED,GITTOES PHARMACEUTICALS LIMITEDFOLIGRAFRECOMBINANT HUMAN FOLLICLE STIMULATING HORMONE75I.U/ VIALBHARAT SERUMS AND VACCINES LIMITED,-PLOT NO. K-27, ADDITIONAL MIDC,
AMBERNATH (EAST), INDIA
INDIAPARENTERAL RETARD OTHER VIALS1.0X1.0 VIAL CARTON
1229NDA/MAL/HDP/4406AGOG PHARMAGITTOES PHARMACEUTICALS LIMITEDSATISFIL -100SILDENAFIL100MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X4.0 TABLET BLISTER
1230NDA/MAL/HDP/4407FRESENIUS KABI MANUFACTURING S.A (PTY) LTDSURGIPHARM (U) LIMITEDSUXAMETHONIUM CHLORIDE- FRESENIUSSUXAMETHONIUM CHLORIDE100MG/2ML FRESENIUS KABI MANUFACTURING S.A (PTY) LTD ?-6 GIBAUD…ROAD KORSTEN, PORT ELIZABETH, SOUTH AFRICA.SOUTH AFRICAPARENTERAL ORDINARY AMPOULES1.0X10.0X2.0 ML AMPOULE
1231NDA/MAL/HDP/4408REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDUNISTEN CREAMCLOTRIMAZOLE1%W/WREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYATOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE
1232NDA/MAL/HDP/4409SANDOZ GBH LTDSURGIPHARM (U) LIMITEDROBESTAR 10MGROSUVASTATIN CALCIUM10MGLEK PHARMACEUTICALS .D.D -VEROVSKOVA 57, 1526 LJUBLJANA
SLOVENIA
SLOVENIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER
1233NDA/MAL/HDP/4411ASTRA ZENECAMACNAUGHTON LIMITEDATACAND PLUSCANDESARTAN + HYDROCHLOROTHIAZIDE16 MG + 12.5 MGASTRA ZENECA AB, SODERTALJE-GARTUNAYEGEN, SODERTALJEUNITED KINGDOMORAL SOLID ORDINARY TABLETS1.0X2.0X14.0 TABLET BLISTER
1234NDA/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 WFI
1235NDA/MAL/HDP/4414SANDOZ KENYA C/O NOVARTIS PHARMA SERVICES INCSURGIPHARM (U) LIMITEDROBESTAR 20MGROSUVASTATIN CALCIUM20MGLEK PHARMACEUTICALS LTD-LEK PHARMACEUTICALS VEROVSKOVA 57 SI 1526 LJUBLJANA SLOVENIASLOVENIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER
1236NDA/MAL/HDP/4415NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDCATAFLAM 5OMG TABLETSDICLOFENAC POTASSIUM50MGNOVARTIS PHARMA SPA,-TORRE ANNUNZIATA ITALY,NOVARTIS--URUNLERI INSTABUL TURKEYITALYORAL SOLID ORDINARY COATED TABLETS10.0X10.0 TABLET BLISTER,1.0X2.0X10.0 TABLET BLISTER
1237NDA/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 AMPOULES
1238NDA/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 NACL
1239NDA/MAL/HDP/4425RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDREQUIN FCQUININE300MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1000.0 TABLET CONTAINER
1240NDA/MAL/HDP/4480MEGA LIFESCIENCES (AUSTRALIA) PTY LTDABACUS PHARMA (AFRICA) LIMITEDKIPEL 5MONTELUKAST5MGMSN LABORATORIES PVT. LIMITED-PLOT NO. 42 ANRICH INDUSTRIAL ESTATE, BOLLARAM MEDAK DISTRICT
PIN CODE 502 325
ANDHRA PRADESH, INDIA.
INDIAORAL SOLID ORDINARY CHEWABLE TABLETS1.0X3.0X10.0 TABLET BLISTER
1241NDA/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 BLISTER
1242NDA/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 BLISTER
1243NDA/MAL/HDP/4523ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDBIGOMET SR 500METFORMIN HYDROCHLORIDE500MGARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO.II,MANDIDEEEP PRADESHINDIAORAL SOLID RETARD TABLETS1.0X3.0X10.0 TABLET BLISTER
1244NDA/MAL/HDP/4524DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDFLUCOZAL 150FLUCONAZOLE150MGAEGIS LTD-17 ATHINON STREET, ERGATON INDUSTRIAL AREA, NICOSIA CYPRUSCYPRUSORAL SOLID ORDINARY CAPSULES1.0X1.0 CAPSULE BLISTER
1245NDA/MAL/HDP/4526AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAZ-500AZITHROMYCIN500MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X3.0 TABLET BLISTER
1246NDA/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 INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER
1247NDA/MAL/HDP/4530DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDTREDOL 100ATENOLOL100MGAEGIS LIMITED -17, ATHINON STREET, ERGATES INDUSTRIAL AREA, 2643 ERGATES, P.O. BOX 28629, 2081, LEFKOSIACYPRUSORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER
1248NDA/MAL/HDP/4531DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDTREDOL 50ATENOLOL50MGAEGIS LIMITED -17, ATHINON STREET, ERGATES INDUSTRIAL AREA, 2643 ERGATES, P.O. BOX 28629, 2081, LEFKOSIACYPRUSORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER
1249NDA/MAL/HDP/4532DELOBORIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDVIRUCID 400ACICLOVIR400 MGAEGIS LTD-17 ATHINON STREET, ERGATON INDUSTRIAL AREA, NICOSIA CYPRUSCYPRUSORAL SOLID ORDINARY OTHER TABLETS1.0X3.0X10.0 TABLET BLISTER
1250NDA/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, CYPRUSCYPRUSORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER
1251NDA/MAL/HDP/4535DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDCLERON 250CLARITHROMYCIN250MGAEGIS LTD-17 ATHINON STREET, ERGATON INDUSTRIAL AREA, NICOSIA CYPRUSCYPRUSORAL SOLID ORDINARY COATED TABLETS1.0X2.0X7.0 TABLET BLISTER
1252NDA/MAL/HDP/4536SEDICO PHARMACEUTICAL CO.WIDE SPECTRUM ENTERPRISES (U) LIMITEDFLUCAMOXFLUCLOXACILLIN + AMOXICILLIN250MG+250MGSEDICO PHARMACEUTICAL CO.-1ST INDUSTRIAL ZONE 6 TH OCTOBER CITY GIZA,EGYPTEGYPTORAL SOLID ORDINARY CAPSULES1.0X4.0X4.0 CAPSULE STRIP
1253NDA/MAL/HDP/4539VENUS REMEDIES LTDAARON PHARMACEUTICALS LTDCRISTOLVINCRISTINE SULPHATE1MGVENUS REMIDIES LTD-UNIT-11 HILL TOP INDUSTRIAL ESTATE JHARMATIINDIAPARENTERAL ORDINARY VIALS1.0X1.0X1.0 ML VIAL
1254NDA/MAL/HDP/4540DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDVIPROLOX500CIPROFLOXACIN500MGAEGIS LTD-17 ATHINON STREET, ERGATON INDUSTRIAL AREA, NICOSIA CYPRUSCYPRUSORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X10.0 TABLET BLISTER
1255NDA/MAL/HDP/4542DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDCLERON 500CLARITHROMYCIN500MGAEGIS LTD-17 ATHINON STREET, ERGATON INDUSTRIAL AREA, NICOSIA CYPRUSCYPRUSORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X14.0 TABLET BLISTER
1256NDA/MAL/HDP/4543SANOFI-AVENTISLABOREX UGANDA LIMITEDRHINATHIOL 5%CARBOCISTEINE5%W/VNATTERMAN & CIE , GMBH NATTERMANNALLEE 1 -,50829 COLOGNE , GERMANYGERMANYORAL LIQUID ORDINARY SYRUPS1.0X125.0 ML BOTTLE
1257NDA/MAL/HDP/4544COSMOS LTDASTRA PHARMA (U) LIMITEDSALBUT TABLET 4MGSALBUTAMOL4MGCOSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREAKENYAORAL SOLID ORDINARY FILM-COATED TABLETS10.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CONTAINER
1258NDA/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 BLISTER
1259NDA/MAL/HDP/4546KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTDTATA UGANDA LIMITEDCHLORAMPHENICOL INJECTION IGCHLORAMPHENICOL SODIUM SUCCINATE1GKARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD- #14, II PHASE PIA, BANGALORE 560058INDIAPARENTERAL ORDINARY DRY VIALS1.0X100.0X1.0 G VIAL,1.0X50.0X1.0 G VIAL
1260NDA/MAL/HDP/4549REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDUNIXIL 500MGAMOXYCILLIN TRIHYDRATE500MGREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER
1261NDA/MAL/HDP/4550SANOFI AVENTS FRANCELABOREX UGANDA LIMITEDRHINATHIOL 2%CARBOCISTEINE20MG/MLUNITHER LIQUID MANUFACTURING INDUSTRIE -COLOMIERS 1-3 ALLE DE LA NESTE L DEN SIGAL 31770,A. NATTERMANN & CIE GMBH.-NATTERMANNALLEE 1 ,50829 COLOGNE, GERMANYFRANCEORAL LIQUID ORDINARY SYRUPS1.0X125.0 ML BOTTLE
1262NDA/MAL/HDP/4553GUILIN PHARMACEUTICALS CO.LTDSTAR PHARMACEUTICALS LTDARTESUNARTESUNATE30MGGUILIN PHARMACEUTICAL CO.,LTD-NO 43 QILIDIAN ROAD GUILIN 541002, GUANGXICHINAPARENTERAL ORDINARY DRY VIALS1.0X30.0 MG VIAL + 1*0.5 ML SODIUM BICARBONATE
1263NDA/MAL/HDP/4556ALKEM LABORATORIES LIMITEDABACUS PHARMA (AFRICA) LIMITEDCLAVAM 375AMOXICILLIN TRIHYDRATE + CLAVULANATE POTASSIUM250MG + 125MGALKEM LABORATORIES LTD--167/1, VILLAGE DABHEL, AMALIYA DAMAN-396210, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X10.0 TABLET STRIP
1264NDA/MAL/HDP/4557HETERO DRUGS LTDABACUS PHARMA (AFRICA) LIMITEDLAMIVUDINELAMIVUDINE150MGHETERO LABS LTD-HETERO LABS LTD, UNIT 111, H22-110, I.D.A, JEEDIMETLA, HYDERABAD, 500055,HETERO LABS LTD (UNIT-V)-SEZ JADCHERIA HYDRABADINDIAORAL SOLID ORDINARY TABLETS1.0X60.0 TABLET BOTTLE
1265NDA/MAL/HDP/4558UNIQUE PHARMACEUTICALS LABORATORIESTATA UGANDA LIMITEDIFICIPRO 500CIPROFLOXACIN500MGUNIQUE PHARMACEUTICALS LABS ( A DIV OF J.B CHEMICALS & PHARMACEUTICAL LTD)--304-308 ,GIDC , PANOLI 394116INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER
1266NDA/MAL/HDP/4559MSN LABORATORIES LTDPLANET PHARMACEUTICALS UGANDA LTDPREGASAFE 75PREGABALIN75MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER
1267NDA/MAL/HDP/4561TORRENT PHARMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.LORVAS SRINDAPAMIDE1.5MGTORRENT PHARMACEUTICALS LTD-VILLAGE. BHUD-MAKHNU MAJRA, TEHSIL: BADDI 173205 DIST SOLAN (H.P)INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET CONTAINER
1268NDA/MAL/HDP/4563TATA UGANDA LIMITEDTATA UGANDA LIMITEDQUININE DIHYDROCHLORIDE INJECTIONQUININE DIHYDROCHLORIDE300MG/MLGLAND PHARMA LTD .-D.P. PALLY, SURVEY 143-148, 150&INDIAPARENTERAL ORDINARY AMPOULES1.0X10.0X2.0 ML AMPOULE
1269NDA/MAL/HDP/4566TATA UGANDA LIMITEDTATA UGANDA LIMITEDFUROSEMIDE INJECTION BPFUROSEMIDE10MG/MLGLAND PHARMA LTD .-D.P. PALLY, SURVEY 143-148, 150&INDIAPARENTERAL ORDINARY AMPOULES1.0X10.0X2.0 ML AMPOULE
1270NDA/MAL/HDP/4568ALKEM LABORATORIES LIMITEDABACUS PHARMA (AFRICA) LIMITEDCLAVAM 625AMOXICILLIN TRIHYDRATE + CLAVULANATE POTASSIUM500MG + 125MGALKEM LABORATORIES LTD--167/1, VILLAGE DABHEL, AMALIYA DAMAN-396210, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X10.0 TABLET STRIP
1271NDA/MAL/HDP/4569KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMADOL SYRUPPARACETAMOL120MG/5MLKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALAUGANDAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE
1272NDA/MAL/HDP/4570AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDNEVIRAPINENEVIRAPINE200MGAUROBINDO PHARMA LTD-UNIT III-SURVEY NO.313,BACHUPALLY VILLAGE,QUTHUBULLAPUR MANDAL R.R DISTRICT(A.P),INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X60.0 TABLET CONTAINER
1273NDA/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 INDIAINDIAORAL SOLID ORDINARY CAPSULES10.0X10.0 CAPSULE STRIP,1.0X1000.0 CAPSULE CONTAINER
1274NDA/MAL/HDP/4573ALKEM LABORATORIES LIMITEDABACUS PHARMA (AFRICA) LIMITEDCLAVAM DT 228.5MGAMOXICILLIN TRIHYDRATE + CLAVULANATE POTASSIUM200MG + 28.5MGALKEM LABORATORIES LTD--167/1, VILLAGE DABHEL, AMALIYA DAMAN-396210, INDIAINDIAORAL SOLID ORDINARY SOLUBLE TABLETS1.0X1.0X10.0 TABLET STRIP
1275NDA/MAL/HDP/4575FDC LTDAIVEEN (U) LIMITEDPYRICORT EYE/EAR DROPSDEXAMETHASONE+GENTAMICIN0.1%+0.3%W/VFDC LIMITED -B-8, M.I.D.C., INDUSTRIAL AREA, WALUJ – AURANGABAD- 431 136 MAHARASHTRA, INDIA. INDIAOPHTHALMIC DROPS1.0X5.0 ML BOTTLE
1276NDA/MAL/HDP/4577ALKEM LABORATORIES LIMITEDABACUS PHARMA (AFRICA) LIMITEDMAGTAMCEFOPERAZONE + SULBACTAM500 MG + 500 MGALKEM LABORATORIES LIMITED.-VILLAGE THANA, BADDI, TEHSIL-NALAGARH, DISTT-SOLAN, (HP), INDIA-173205INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0 G VIAL
1277NDA/MAL/HDP/4579ACINO PHARMA AGGOODMAN INTERNATIONAL LTDMESPORIN 500 IV VIALSCEFTRIAXONE500MGLABESFAL LABORATORIOS ALMIRO, S.A ,.-ZONA INDUSTRIAL DO LABENGO, 3465-157 SANTIAGO DE BESTEIROSPORTUGALPARENTERAL ORDINARY DRY VIALS1.0X500.0 MG VIAL + 1*5 ML WFI AMPOULE
1278NDA/MAL/HDP/4581ALKEM LABORATORIES LIMITEDABACUS PHARMA (AFRICA) LIMITEDCLAVAM 1000AMOXICILLIN TRIHYDRATE + CLAVULANATE POTASSIUM875MG + 125MGALKEM LABORATORIES LTD--167/1, VILLAGE DABHEL, AMALIYA DAMAN-396210, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X10.0 TABLET STRIP
1279NDA/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 INDIAINDIAPARENTERAL ORDINARY AMPOULES1.0X10.0X10.0X1.0 ML AMPOULE
1280NDA/MAL/HDP/4588LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDFLUCAN 200FLUCONAZOLE200MGLINCOLN PHARMACEUTICAL LIMITED-TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X1.0 TABLET BLISTER
1281NDA/MAL/HDP/4591S KAGE EXPORTSABACUS PHARMA (AFRICA) LIMITEDSILVER KANTSILVER SULPHADIAZINE USP1%W/WS.KANT HEALTHCARE LTD-1802-18-5 GIDC PHASE III, VAPI-396195,GUJARAT INDIAINDIATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE
1282NDA/MAL/HDP/4592LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDPENTALINK 40PANTOPRAZOLE40MGLINCOLN PHARMACEUTICAL LIMITED-TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIAINDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X10.0X10.0 TABLET STRIP,1.0X3.0X10.0 TABLET BLISTER
1283NDA/MAL/HDP/4593SK AGE EXPORTSABACUS PHARMA (AFRICA) LIMITEDERYTHROKANT-250ERYTHROMYCIN STEARATE250MGS.KANT HEALTHCARE LTD-PLOT 1802, 1805, GIDC PHASE III VAPI 39179, GUJARATINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER
1284NDA/MAL/HDP/4594CADILA HEALTHCARE LTDABACUS 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 BLISTER
1285NDA/MAL/HDP/4595LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDVAST-20ATORVASTATIN20MGLINCOLN PHARMACEUTICAL LIMITED-TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER
1286NDA/MAL/HDP/4598AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAZ-250AZITHROMYCIN250MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X6.0 TABLET BLISTER
1287NDA/MAL/HDP/4601SANOFI PASTEURLABOREX UGANDA LIMITEDPENTAXIM VACCINEMULTI-INGREDIENTMULTI-INGREDIENTSANOFI PASTEUR-1541 AVENUE MARCEL MERIEUX, 69280 MARCY, LETOILE,SANOFI PASTEUR S.A-2,AVENUE PONT PASTEUR 69007 LYON-FRANCE(BUSINESS ADDRESS)FRANCEPARENTERAL ORDINARY I M PRE-FILLED SYRINGES1.0X0.5 ML PRE- FILLED SYRINGE,1.0X0.5 ML VIAL
1288NDA/MAL/HDP/4602ELI-LILLY (SUISSE) SALABOREX UGANDA LIMITEDHUMALOG MIX 50INSULIN LISPRO100 .IU(50 I.U+50 I.U)LILLY FRANCE SA-FRANCEFRANCEPARENTERAL ORDINARY S C VIALS1.0X3.0 ML VIAL,1.0X5.0 ML VIAL
1289NDA/MAL/HDP/4603REMEDICA LTDGOODMAN INTERNATIONAL LTDHALOXEN - 5HALOPERIDOL5MGREMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHARCYPRUSORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER
1290NDA/MAL/HDP/4605AGOG PHARMA 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 INDIAINDIAORAL LIQUID ORDINARY SYRUPS1.0X1.0X100.0 ML BOTTLE,1.0X1.0X60.0 ML BOTTLE
1291NDA/MAL/HDP/4606INTAS PHARMACEUTICALS LIMITEDNORVIK ENTERPRISES LIMITEDROVAS 10ROSUVASTATIN10MGINTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER
1292NDA/MAL/HDP/4609ELYS CHEMICAL INDUSTRIES LTDVELVET PHARMA LIMITEDELYCORTHYDROCORTISONE1%W/WELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBIKENYATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE
1293NDA/MAL/HDP/4611DAFRA PHARMA LTDLABOREX UGANDA LIMITEDDAFRACLAVAMOXYCILLIN + POTASSIUM CLAVULANATE200MG + 28MGBILIM PHARMACEUTICALS-ISLETMESI 59501 CERKEZKOY TEKIRDAGTURKEYORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X70.0 ML BOTTLE
1294NDA/MAL/HDP/4614GALENTIC PHARMA LTDNORVIK ENTERPRISES LIMITEDCOMPOUND BENZOIC ACID OINTMENTBENZOIC ACID + SALICYLIC ACID6 %W/W + 3 %W/WGALENTIC PHARMA( INDIA ) PVT LTD-R-673,MIDC TTC RABALE THANE-BELAPUR ROAD,NAVIINDIATOPICAL EXTERNAL OINTMENTS1.0X25.0 G TUBE,1.0X500.0 G TUBE
1295NDA/MAL/HDP/4615NVS KENYA LTDSURGIPHARM (U) LIMITEDTASIGNA 150NILOTONIB HYDROCHLORIDE MONOHYDRATE150MGNOVARTIS PHARMA STEIN AG-SCHAFFHARVSERTRASSE CH-4332 STEIN SWITZERLAND.SWITZERLANDORAL SOLID ORDINARY CAPSULES1.0X7.0X4.0 CAPSULE BLISTER
1296NDA/MAL/HDP/4617ASTRA ZENECAMACNAUGHTON LIMITEDCRESTORROSUVASTATIN10MGIPR PHARMACEUTICALS INC,-LOT 17 INDUSTRIAL PARK PUERTO RICO, SAN ISIDRO, PUERTO RICOPUERTO RICOORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X14.0 TABLET BLISTER
1297NDA/MAL/HDP/4620GLAXO SMITH KLINE LTDERIS LTDMALANIL PAEDIATRIC TABLETATOVAQUONE + PROGUANIL62.5 MG + 25.0 MGGLAXO WELLCOME S.A ARANDA-ARANDA AVDA EXTREMADURA 3, 09400 ARANDA DE DUERO BURGOSSPAINORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X12.0 TABLET BLISTER
1298NDA/MAL/HDP/4621CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDCARVIL 6.25CARVEDILOL6.25MGCADILA HEALTHCARE LTD--PLOT 203-213, KUNDAIM INDUSTRIAL ESTATE, GOA 403401INDIAORAL SOLID ORDINARY TABLETS10.0X10.0 TABLET BLISTER
1299NDA/MAL/HDP/4622RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDCLOXARENCLOXACILLIN250MGRENE INDUSTRIES-PLOT 680 KAMULI KIREKAUGANDAORAL SOLID ORDINARY CAPSULES10.0X10.0 CAPSULE BLISTER
1300NDA/MAL/HDP/4623RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDLOPERARENLOPERAMIDE HYDROCHLORIDE2MGRENE INDUSTRIAL LTD-RENE INDUSTRIES LTD, PLOT 680, KAMULI-KIREKA KAMPALA UGANDAUGANDAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER
1301NDA/MAL/HDP/4626ACINO PHARMA AGGOODMAN INTERNATIONAL LTDGASEC-20OMEPRAZOLE20MGACINO PHARMA AG -DORNACHERSTRASSE, 114, 4147, AESCH, SWITZERLANDSWITZERLANDORAL SOLID ORDINARY CAPSULES1.0X1.0X14.0 CAPSULE BOTTLE
1302NDA/MAL/HDP/4627LABORATORY AND ALLIED LTDHARLEYS UGANDA LIMITEDHYCORUM CREAMHYDROCORTISONE1%W/WLABORATORY AND ALLIED LTD-PLOT 209/10349-MOMBASA ROAD NAIROBIKENYATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE
1303NDA/MAL/HDP/4629DAWA LIMITEDSUPER MEDIC LTDORACEFCEFALEXIN MONOHYDRATE125MG/5MLDAWA LTD-BABA DOGO ROAD RUARAKAKENYAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE
1304NDA/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 BLISTER
1305NDA/MAL/HDP/4635SANOFI-AVENTISLABOREX UGANDA LIMITEDRHINATHIOL 5%CARBOCISTEINE5%W/VUNITHER LIQUID MANUFACTURING INDUSTRIE -COLOMIERS 1-3 ALLE DE LA NESTE L DEN SIGAL 31770FRANCEORAL LIQUID ORDINARY SYRUPS1.0X125.0 ML BOTTLE
1306NDA/MAL/HDP/4636DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDZOLARAM 0.5ALPRAZOLAM0.5MGAEGIS LIMITED -17, ATHINON STREET, ERGATES INDUSTRIAL AREA, 2643 ERGATES, P.O. BOX 28629, 2081, LEFKOSIACYPRUSORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER
1307NDA/MAL/HDP/4637ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDPARACETAMOLPARACETAMOL500MGHEBEI (JIHENG GRP) PHARMACEUTICALS CO.LTD-368 JIANSHE ST HENGSHUI CITY HEBEI 053000CHINAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER
1308NDA/MAL/HDP/4641YURIA PHARM EAST AFRICA LIMITEDYURIA PHARM EAST AFRICA LIMITEDRHEOSORBILACTSORBITOL + SODIUM LACTATE + NACL + CALCIUM CHLORIDE + MAGNESIUM CHLORIDE6G +1.9G +0.6G + 0.01G +0.03G +0.02YURIA-PHARM, LTD.-18030 VERBOVETSKOGO STR. 108 CHERKASSY, UKRAINE.UKRAINEPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X200.0 ML BOTTLE,1.0X400.0 ML BOTTLE
1309NDA/MAL/HDP/4645ASTRA ZENECAMACNAUGHTON LIMITEDCRESTORROSUVASTATIN CALCIUM20MGIPR PHARMACEUTICALS INC,-LOT 17 INDUSTRIAL PARK PUERTO RICO, SAN ISIDRO, PUERTO RICOPUERTO RICOORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X14.0 TABLET BLISTER
1310NDA/MAL/HDP/4646YURIA PHARM EAST AFRICA LIMITEDYURIA PHARM EAST AFRICA LIMITEDLEFLOCINLEVOFLOXACIN5MG/MLYURIA-PHARM, LTD.-18030 VERBOVETSKOGO STR. 108 CHERKASSY, UKRAINE.UKRAINEPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X1.0X150.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE
1311NDA/MAL/HDP/4647CIPLA LTD..QUALITY CHEMICALS LTD - HUMANLEVOLINLEVOSALBUTAMOL50MCGCIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOAINDIANASAL SYSTEMIC METERED-DOSE LIQUIDS1.0X200.0 METERED DOSE CANNISTER
1312NDA/MAL/HDP/4650NORVATIS PHARMA AG- SWITZERLANDLABOREX UGANDA LIMITEDDUOTRAVTRAVOPROST + TIMOLOL MALEATE40MG/ML + 5MG/MLALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUMBELGIUMOPHTHALMIC DROPS1.0X1.0X2.5 ML VIAL
1313NDA/MAL/HDP/4652SERUM INSTITUTE OF INDIA LTD.NORVIK ENTERPRISES LIMITEDSII TETANUS TOXOID VACCINETETANUS TOXOID ADSORBED ON ALUMINIUM PHOSPHATE? 5 LF (? 40 IU) ON ? 1.25 MG OF ALUMINIUM PHOSPHATESERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIAINDIAPARENTERAL ORDINARY AMPOULES1.0X5.0 ML AMPOULE (1 DOSE AMPOULE),1.0X10.0 ML VIAL (20 DOSE VIAL)
1314NDA/MAL/HDP/4655YURIA PHARM EAST AFRICA LIMITEDYURIA PHARM EAST AFRICA LIMITEDDECASANDECAMETHOXIN0.2MG/1MLYURIA-PHARM, LTD-108, VERBOVETSKOGO STREET CHERKASSY, 18030, UKRAINEUKRAINETOPICAL EXTERNAL LIQUIDS1.0X200.0 ML BOTTLE,1.0X100.0 ML BOTTLE,1.0X400.0 ML BOTTLE,1.0X1000.0 ML CONTAINER,1.0X2.0 ML CONTAINER
1315NDA/MAL/HDP/4656ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDASCETCETIRIZINE10MGASTRA LIFE CARE(INDIA) PVT LTD-57/P, POJODA, 382220, BOVIA, AHMEDOBAD, INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER
1316NDA/MAL/HDP/4658PT SANBE FARMAMEDVIN PHARMA LIMITEDMEROSAN 0.5MEROPENEM0.5GPT SANBE FARMA-JI LEUWIGAJAH I62 CIMINDI CIMAHI WEST JAVA INDONESIAINDONESIAPARENTERAL ORDINARY DRY VIALS1.0X0.5 G VIAL
1317NDA/MAL/HDP/4660DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDKIMSY MEDS LTDRISDONE 2MGRISPERIDONE2MGDAR AL DAWA-DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD. NA’UR PRINCE HASHEM BIN AL-HUSSEIN STREET. AMMAN, JORDANJORDANORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X10.0 TABLET BLISTER
1318NDA/MAL/HDP/4661YURIA PHARM EAST AFRICA LIMITEDYURIA PHARM EAST AFRICA LIMITEDFLUCONAZOLE-UFFLUCONAZOLE2MG/MLYURIA-PHARM, LTD-108, VERBOVETSKOGO STREET CHERKASSY, 18030, UKRAINEUKRAINEPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X50.0 ML BOTTLE,1.0X100.0 ML BOTTLE
1319NDA/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 INDIAINDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER
1320NDA/MAL/HDP/4663DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDKIMSY MEDS LTDLORATANLORATIDINE5MG/5MLDAR AL DAWA-DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD. NA’UR PRINCE HASHEM BIN AL-HUSSEIN STREET. AMMAN, JORDANJORDANORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE
1321NDA/MAL/HDP/4665YURIA PHARM LTDYURIA PHARM EAST AFRICA LIMITEDORNIGILORNIDAZOLE5MG/MLYURIA-PHARM, LTD. -18030 VERBOVETSKOGO STR. 108 CHERKASSY, UKRAINE..UKRAINEPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X200.0 ML BOTTLE,1.0X100.0 ML BOTTLE
1322NDA/MAL/HDP/4677: ALKEM LABORATORIES LIMITED?ABACUS PHARMA (AFRICA) LIMITEDZOCEFCEFUROXIME125MG/5MLALKEM LABORATORIES LIMITED.-VILLAGE THANA, BADDI, TEHSIL-NALAGARH, DISTT-SOLAN, (HP), INDIA-173205INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X1.0X30.0 ML BOTTLE,1.0X70.0 ML BOTTLE
1323NDA/MAL/HDP/4678: ALKEM LABORATORIES LIMITED?ABACUS PHARMA (AFRICA) LIMITEDZOCEF-500CEFUROXIME AXETIL500MGALKEM LABORATORIES LIMITED.-VILLAGE THANA, BADDI, TEHSIL-NALAGARH, DISTT-SOLAN, (HP), INDIA-173205INDIAORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER
1324NDA/MAL/HDP/4681SANOFI AVENTISLABOREX UGANDA LIMITEDINSUMAN COMB 30DISSOLVED INSULIN+CRYSTALLINE PROTAMINE INSULIN30%+70%SANOFI-AVENTIS DEUTSCHLAND GMBH -INDUSTRIEPARK HOECHST, BRUNINGSTRASSEN, BUILDING
H650 65926 FRANKFURT AM MAIN, GERMANY
GERMANYPARENTERAL ORDINARY VIALS1.0X5.0X3.0 ML CARTRIDGE
1325NDA/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 BOTTLE
1326NDA/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 BOTTLE
1327NDA/MAL/HDP/4690ELYS CHEMICAL INDUSTRIES LTDVELVET PHARMA LIMITEDELYPENPHENOXYMETHYL PENICILLIN250MGELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBIKENYAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
1328NDA/MAL/HDP/4693ELYS CHEMICAL INDUSTRIES LTDVELVET PHARMA LIMITEDELYVATEBETAMETHASONE VALERATE1%W/WELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBIKENYATOPICAL EXTERNAL OINTMENTS1.0X15.0 G TUBE
1329NDA/MAL/HDP/4694MERCK SHARP & DOHME INTAPHARMAPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDROTATEQROTAVIRUS LIVE REASSORTANT VIRUS G1+G2+G3+G4 &P12.2M IU+2.8M IU+2.2M IU+2.0M IUMERK & CO. INC-SUMNEYTOWN PIKE, P.O BOX 4, WEST POINT, PENNSYLVANIA, U.S. 19486, USAUNITED STATESORAL LIQUID ORDINARY EMULSIONS1.0X10.0 ML BOTTLE
1330NDA/MAL/HDP/4697PT SAMBE FARMAMEDVIN PHARMA LIMITEDSANBE CLANEKSIAMOXICILLIN + CLAVULANIC ACID1000 MG + 200 MGPT SANBE FARMA-JI LEUIGAJAH NO. 162 CIMINDI, INDONESIAINDONESIAPARENTERAL ORDINARY VIALS1.0X6.0 VIAL CARTON
1331NDA/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 CONTAINER
1332NDA/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 BOTTLE
1333NDA/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 BOTTLE
1334NDA/MAL/HDP/4705DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDKIMSY MEDS LTDDICLOGESIC-50DICLOFENAC50MGDAR AL DAWA-DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD. NA’UR PRINCE HASHEM BIN AL-HUSSEIN STREET. AMMAN, JORDANJORDANRECTAL SYSTEMIC SUPPOSITORIES1.0X2.0X5.0 SUPPOSITORY BLISTER
1335NDA/MAL/HDP/4706WIN-MEDICARE PVT LTDSURGIPHARM (U) LIMITEDDICLOMOL GELDICLOFENAC DIETHYLAMINE1.16%W/WG,S PHARMBUTOR PVT LTD -B-172 INDUSTRIAL AREA BEHROR 301701 RAJASTHANINDIATOPICAL EXTERNAL GELS AND SOLS1.0X20.0 G CONTAINER
1336NDA/MAL/HDP/4707WIN-MEDICARE PVT LTDSURGIPHARM (U) LIMITEDDICLOMOL INJECTIONDICLOFENAC SODIUM25MG/MLWIN MEDICARE PVT LIMITED-MEERUT, MUZAFFARNAGER ROAD, MODIPURAM – 250110, UTTAR
PRADESH - INDIA
INDIAPARENTERAL ORDINARY AMPOULES1.0X3.0 ML AMPOULE
1337NDA/MAL/HDP/4710COSMOS LTDASTRA PHARMA (U) LIMITEDMEDOPRESS TABLETS 250MGMETHYLDOPA250MGCOSMOS LIMITED..-RANGWE ROAD, OFF LUNGA LUNGA ROAD, INDUSTRIAL AREAKENYAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
1338NDA/MAL/HDP/4712ABACUS PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDMEFINAL-500MEFENAMIC ACID500MGMAXHEAL PHARMACEUTICALS INDIA LTD-J-7 MIDC, TARAPUR INDUSTRIAL AREA, BOISAR- 401506, DIST.THANE, MARAHASHTRA, INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER
1339NDA/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 BOTTLE
1340NDA/MAL/HDP/4714PHARCO PHARMACEUTICALSWIDE SPECTRUM ENTERPRISES (U) LIMITEDCEPHOXIN 250MG/5MLCEPHALEXIN250MG/5MLPHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT.
P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT
EGYPTORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE
1341NDA/MAL/HDP/4718MEGA LIFESCIENCES (AUSTRALIA) PTY LTDSURGIPHARM (U) LIMITEDACNOTIN 20ISOTRETINOIN20MGMEGA LIFE SCIENCES PUBLIC COMPANY LIMITED-384 SOIB PATTANA 3 RD BANGPOO INDUSTRIAL ESTATE SAMUTPRAKARN 10280THAILANDORAL SOLID ORDINARY OTHER CAPSULES1.0X3.0X10.0 CAPSULE BLISTER
1342NDA/MAL/HDP/4719MEGA LIFESCIENCES (AUSTRALIA) PTY LTDSURGIPHARM (U) LIMITEDACNOTIN 10ISOTRETINOIN10MGMEGA LIFE SCIENCES PUBLIC COMPANY LIMITED-384 SOIB PATTANA 3 RD BANGPOO INDUSTRIAL ESTATE SAMUTPRAKARN 10280THAILANDORAL SOLID ORDINARY OTHER CAPSULES1.0X3.0X10.0 CAPSULE BLISTER
1343NDA/MAL/HDP/4720SQUARE CEPHALOSPORINS LTDGAMA PHARMACEUTICALS (U) LIMITEDCEFTRONCEFTRIAXONE1GSQUARE PHARMACEUTICALS LIMITED--DHAKA UNIT KALIAKOIR GAZIPUR – 1750, BANGLADESHBANGLADESHPARENTERAL ORDINARY DRY VIALS1.0X1.0 G VIAL + 1*10 ML AMPOULE WATER FOR INJECTION
1344NDA/MAL/HDP/4721PT SAMBE FARMAMEDVIN PHARMA LIMITEDMEGABALMECOBALAMIN5000MCGPT SANBE FARMA,UNIT 1-JI INDUSTRI NO.9 LEUWIGAJAH CIMINDI CIMAHI WEST JAVA,INDONESIAINDONESIAORAL SOLID ORDINARY OTHER CAPSULES1.0X10.0X10.0 CAPSULE STRIP
1345NDA/MAL/HDP/4722GLAXO SMITHKLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDACTIFED COLD TABLETSTRIPROLIDINE HYDROCHLORIDE+PSEUDOPHEDRINE HYDROCHLORIDE2.5MG+60MGGLAXO WELLCOME PRODUCTION -Z.I DE LA PEYENNIERE 53100 MAYENNE FRANCEFRANCEORAL SOLID ORDINARY TABLETS1.0X500.0 TABLET BLISTER,1.0X12.0 TABLET BLISTER,1.0X96.0 TABLET BLISTER,1.0X480.0 TABLET BLISTER
1346NDA/MAL/HDP/4723REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDMEGYL SUSPENSIONMETRONIDAZOLE BENZOATE200MG/5MLREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE
1347NDA/MAL/HDP/4724GLAXOSMITH KLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDACTIFED DRY COUGH & COLDTRIPROLIDINE HYDROCHLORIDE+PSEUDOEPHEDRINE HYDROCHLORIDE+DEXTROMETHORPHAN1.25MG+30MG+10MGGLAXO WELLCOME PRODUCTION -Z.I DE LA PEYENNIERE 53100 MAYENNE FRANCEFRANCEORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE,1.0X2.0 L BOTTLE
1348NDA/MAL/HDP/4725REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDMEGYL TABLETMETRONIDAZOLE200MGREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X250.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER
1349NDA/MAL/HDP/4726MACK BROWN PHARMACEUTICALS PVT LIMITEDSHURIK LTDADB MIN MULTIPOWERMULTI-INGREDIENTMULTI-INGREDIENTTORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506INDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE,1.0X300.0 ML BOTTLE
1350NDA/MAL/HDP/4728M.J.BIOPHARM PVT LTDTATA UGANDA LIMITEDADRENALINEADRENALINEIMG/MLM.J BIOPHARM PVT LTD-TALOJA DISTRICT RAIGAD 410208 NAVI MUMBAIINDIAPARENTERAL ORDINARY AMPOULES1.0X10.0X10.0 ML AMPOULE
1351NDA/MAL/HDP/4730SANOFI PASTEURLABOREX UGANDA LIMITEDMENACTRAMENINGOCOCCAL GROUPS (A + C +Y + W-135) + POLYSACCHARIDE DIPTHERIA TOXOID CONJUGATE VACCINE4MCG + 4MCG + 4MCG + 4MCG + 48MCGSANOFI PASTEUR-INC DISCOVERY DRIVE SWIFTWATER PENNSYLVANIA 183370-0187UNITED STATESPARENTERAL ORDINARY I M VIALS1.0X5.0 ML VIAL (10 DOSE VIAL)
1352NDA/MAL/HDP/4731SERUM INSTITUTE OF INDIA LTD.NORVIK ENTERPRISES LIMITEDMENAFRIVACMENINGOCOCCAL A CONJUGATE VACCINE10MCG/ 0.5ML + 10-33MCG/0.5MLSERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIAINDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0X10.0 DOSE VIAL + 1*5ML AMPOULE OF DILUENT
1353NDA/MAL/HDP/4735MENTHOLATUMHARLEYS UGANDA LIMITEDMENTHOLATUM BALMMULTI-INGREDIENTMULTI-INGREDIENTTHE MENTHOLATUM COMPANY LTD- TWYFORD, BENKSHIRE, EUNITED KINGDOMTOPICAL EXTERNAL OINTMENTS1.0X30.0 G TUBE,1.0X4.0 G TUBE
1354NDA/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 INDIAINDIAORAL LIQUID ORDINARY DROPS1.0X10.0 ML BOTTLE
1355NDA/MAL/HDP/4738NORVATIS PHARMA AG- SWITZERLANDLABOREX UGANDA LIMITEDCILOXANCIPROFLOXACIN0.3%W/VALCON -ALCON COUVREUR NV B-2870 PUURS BELGIUMBELGIUMOPHTHALMIC DROPS1.0X5.0 ML BOTTLE
1356NDA/MAL/HDP/4739SWISS PARENTERALS PVT. LTD.SHREEJI PHARMACEUTICALS LIMITEDMEROMEROPENEM1GSWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIAINDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0 G VIAL
1357NDA/MAL/HDP/4743DAFRA PHARMA N.V/S.ALABOREX UGANDA LIMITEDMERONIA 1000MEROPENEM1000MGPHARMATHEN S.A-6,DERVENAKION STR,PALLINI,AHICA GREECEGREECEPARENTERAL ORDINARY VIALS1.0X1000.0 MG VIAL
1358NDA/MAL/HDP/4744DAFRA PHARMA N.V/S.ALABOREX UGANDA LIMITEDMERONIA 500MEROPENEM500MGPHARMATHEN S.A-6,DERVENAKION STR,PALLINI,AHICA GREECEGREECEPARENTERAL ORDINARY DRY VIALS1.0X500.0 MG VIAL
1359NDA/MAL/HDP/4745ALKEM LABORATORIES LIMITEDABACUS PHARMA (AFRICA) LIMITEDPIPZOPIPERACILLIN + TAZOBACTAM4.5GALKEM LABORATORIES LTD--PLOT NO. 167/1, MAHATMA GANDHI UDYONG NAGAR, AMALIYA, DABHEL, DAMAN,396210 INDIA.INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0X4.5 G VIAL
1360NDA/MAL/HDP/4746MIRACALUS PHARMA PVT.LTDAIVEEN (U) LIMITEDABINGEM-200GEMCITABINE200MGNAPROD LIFE SCIENCES PVT LTD-G-17, MIDC, TARAPUR INDUSTRIAL AREA, BIOSAR THANE, MUMBAIINDIAPARENTERAL ORDINARY VIALS1.0X200.0 MG VIAL
1361NDA/MAL/HDP/4747RIVA PHARMA FREE ZONEWIDE SPECTRUM ENTERPRISES (U) LIMITEDZITHRORIVAZITHROMYCIN200MG/5MLRIVA PHARMA FREE ZONE-NASR CITY CAIRO EGYPTEGYPTORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X22.5 ML BOTTLE
1362NDA/MAL/HDP/4748MEDICAL UNION PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.ACICONE-S CHEWABLE TABLETMAGALDRATE+SIMETHICONE720MG+25MGMEDICAL UNION PHARMA .CO-ABU-SULTAN ISMAILIA EGYPTEGYPTORAL SOLID ORDINARY CHEWABLE TABLETS1.0X5.0X4.0 TABLET BLISTER
1363NDA/MAL/HDP/4749PT SANBE FARMAMEDVIN PHARMA LIMITEDMEROSANMEROPENEM1GPT SANBE FARMA-JI LEUWIGAJAH I62 CIMINDI CIMAHI WEST JAVA INDONESIAINDONESIAPARENTERAL ORDINARY DRY VIALS1.0X1.0 G VIAL
1364NDA/MAL/HDP/4751AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDFEROLFERROUS SULPHATE200MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY COATED TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER
1365NDA/MAL/HDP/4752PFIZER LABORATORIES LTDLABOREX UGANDA LIMITEDADRIBLASTINA RDDOXORUBICIN HYDROCHLORIDE10MGPHARMACIA AND UPJOHN S.P.A ITALY-VIA COMMESCION MARINO DEL TRONTO(ASCOLI PICENE)ITALYITALYPARENTERAL ORDINARY OTHER VIALS1.0X10.0 ML VIAL
1366NDA/MAL/HDP/4755BAYER SCHERING AGSURGIPHARM (U) LIMITEDADVANTAN CREAMMETHYL PREDNISOLONE ACEPONATE0.1%W/WBAYER HEALTH CARE MANUFACTURING S.R.I -S.P.A VIA SCHERING,21 20090 SEGRATE (MILAN) ITALYITALYTOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE
1367NDA/MAL/HDP/4757ERIS LTDBENLE CONSULT LIMITEDMETFORMIN-DENK 500METFORMIN500MGDENK PHARMA GMBH &CO.KG--PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANYGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER
1368NDA/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 GERMANYGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X15.0 TABLET BLISTER
1369NDA/MAL/HDP/4761ZAHRAVI PHARMACEUTICAL COMPANYUNEED GLOBAL GROUP LIMITEDADVIFENIBUPROFEN400MGZAHRAVI PHARMACEUTICAL COMPANY-19TH KM TABRIZ TEHRAN ROAD OPPOSITE TO THE AGRICULTURE TRAINING CENTER TABRIZIRANORAL SOLID ORDINARY COMBINATION PACK CAPSULES1.0X10.0X5.0 CAPSULE BLISTER
1370NDA/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 INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X30.0 ML BOTTLE
1371NDA/MAL/HDP/4769AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOBEXMEBENDAZOLE100MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY CHEWABLE TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER
1372NDA/MAL/HDP/4771ROTEX MEDICA GBH ARZNEIMITTELIGITTOES PHARMACEUTICALS LIMITEDMETHYLERGOMETRINEMETHYLERGOMETRINE MALEATE20MCG/MLROTEXMEDICA GMBH ARZEIMITTEL WERK-BUNSENSTRASSE 4, 22946 TRITTAUGERMANYPARENTERAL ORDINARY AMPOULES1.0X1.0 ML AMPOULE
1373NDA/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 BLISTER
1374NDA/MAL/HDP/4778PHARCO PHARMACEUTICALSWIDE SPECTRUM ENTERPRISES (U) LIMITEDCURISAFECEFADROXIL MONOHYDRATE125MG/5MLPHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT.
P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT
EGYPTORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X60.0 ML BOTTLE
1375NDA/MAL/HDP/4781CYANO PHARMA(P)RENE PHARMACY LTDCYANO IRON TABLETSFERROUS SULPHATE200MGCYANO PHARMA(P)-115-C IND ESTATE POLO GROUND INDOREINDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
1376NDA/MAL/HDP/4782VHB MEDI SCIENCES LTDLLOYDS PHARMACY UGANDA LTD.CYBIN PFCYTARABINE100MG/MLVHB MEDI SCIENCES LTD-PLOT 20, 21, 22 & 49,50, 51. INTEGRATED INDUSTRIAL AREA SECTOR 5, RUDRAPUR, UTTARAKHAND - INDIAINDIAPARENTERAL ORDINARY AMPOULES1.0X2.0 ML AMPOULE
1377NDA/MAL/HDP/4783CIRON DRUGS AND PHARMACEUTICALS PVT LTDRENE PHARMACY LTDCYPOTINCYPROHEPTADINE HYDROCHLORIDE2MG/5MLCIRON DRUGS & PHARMACEUTICALS PVT LTD-N-118, N-119 MIDC TARAPUR BOISAR DIST THANE 401506 MAHARASHTRA INDIAINDIAORAL LIQUID ORDINARY LIQUIDS1.0X100.0 ML BOTTLE
1378NDA/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 BOTTLE
1379NDA/MAL/HDP/4785JASSEN-CILAG (PTY) LTDLABOREX UGANDA LIMITEDDAKTACORTMICONAZOLE NITRATE+HYDROCORTISONE2%W/W+1%W/WSPECPHARM HOLDINGS- 15TH ROAD HALFWAY HOUSESOUTH AFRICATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE
1380NDA/MAL/HDP/4786MISSION PHARMA A/SJOINT MEDICAL STORE (UPMB - UCMB)COTRIMOXAZOLE 960MGSULPHAMETHOXAZOLE + TRIMETHOPRIM800MG + 160MGMEDICAMEN BIOTECH LTD-SP-1192, A &B, PHASE –IV,
INDUSTRIAL AREA BHIWADI -301019 DIST. ALWAR (RAJASTHAN)
INDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER
1381NDA/MAL/HDP/4787JASSEN-CILAG (PTY) LTDLABOREX UGANDA LIMITEDDAKTARINMICONAZOLE NITRATE20MG/GSPECPHARM HOLDINGS- 15TH ROAD HALFWAY HOUSESOUTH AFRICATOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE
1382NDA/MAL/HDP/4788JASSEN-CILAG (PTY) LTDLABOREX UGANDA LIMITEDDAKTARIN ORAL GELMICONAZOLE NITRATE20MG/GSPECPHARM HOLDINGS- 15TH ROAD HALFWAY HOUSESOUTH AFRICAORAL TOPICAL GELS AND SOLS1.0X40.0 G TUBE
1383NDA/MAL/HDP/4789PFIZER LABORATORIES PTY LTDLABOREX UGANDA LIMITEDDALACIN CCLINDAMYCIN HYDROCHLORIDE300MGFAREVA AMBOISE - -ZONE INDUSTRIELLE, 29 ROUTE DES INDUSTRIES, 37530 POCE SUR CISSE, FRANCEFRANCEORAL SOLID ORDINARY CAPSULES1.0X100.0 CAPSULE CARTON,1.0X2.0X8.0 CAPSULE STRIP
1384NDA/MAL/HDP/4790PFIZER LABORATORIES (PTY) LTDLABOREX UGANDA LIMITEDDALACIN CCLINDAMYCIN HYDROCHLORIDE150MGFAREVA AMBOISE - -ZONE INDUSTRIELLE, 29 ROUTE DES INDUSTRIES, 37530 POCE SUR CISSE, FRANCEBELGIUMORAL SOLID ORDINARY CAPSULES1.0X2.0X8.0 CAPSULE STRIP,1.0X100.0 CAPSULE CARTON
1385NDA/MAL/HDP/4791PFIZER LABORATORIES (PTY) LTDLABOREX UGANDA LIMITEDDALACIN CCLINDAMYCIN PALMITATE75MG/5MLPHARMACIA AND UPJOHN S.P.A-RIJKSWEG 12, B-2870 PUURSBELGIUMORAL LIQUID ORDINARY OTHER POWDERS/GRANULES1.0X80.0 ML BOTTLE
1386NDA/MAL/HDP/4792PFIZER LABORATORIES (PTY) LTDLABOREX UGANDA LIMITEDDALACIN CCLINDAMYCIN PHOSPHATE150MG/MLPFIZER GLOBAL MANUFACTURING BELGIUM NV-RIJKSWEG 12, 2870 PUURS - BELGIUMBELGIUMPARENTERAL ORDINARY VIALS1.0X4.0 ML VIAL,1.0X2.0 ML VIAL
1387NDA/MAL/HDP/4793PFIZER LABORATORIES (PTY) LTDLABOREX UGANDA LIMITEDDALACIN TCLINDAMYCIN PHOSPHATE1%W/VPHARMACIA AND UPJOHN S.P.A-RIJKSWEG 12, B-2870 PUURSBELGIUMTOPICAL EXTERNAL LIQUIDS1.0X30.0 ML BOTTLE
1388NDA/MAL/HDP/4794NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDDALADOLDICLOFENAC SODIUM + PARACETAMOL50MG+500MGNEM LABORATORIES PVT LTD-133 KRISHNA INDUSTRIAL ESTATE VASAI (E) DIST THANE 401 210 MAHARASHTRAINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER
1389NDA/MAL/HDP/4795DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDKIMSY MEDS LTDDAROXIMECEFUROXIME500MGDAR AL DAWA-DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD. NA’UR PRINCE HASHEM BIN AL-HUSSEIN STREET. AMMAN, JORDANJORDANORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BOTTLE
1390NDA/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 BOTTLE
1391NDA/MAL/HDP/4798VENUS REMIDIES LTDAARON PHARMACEUTICALS LTDCITABOLGEMCITABINE2MG/MLVENUS REMEDIES LTD, UNIT II,-HILL TOP INDUSTRIAL ESTATE, JHARMAJTI, EPIP, PHASE-1 (EXTENSION), BHATOLI KALAN, BADDI -HPINDIAPARENTERAL ORDINARY VIALS1.0X50.0 ML VIAL
1392NDA/MAL/HDP/4799PHARCO PHARMACEUTICALSWIDE SPECTRUM ENTERPRISES (U) LIMITEDCITROLIN SOLUTIONCETRIMIDE+LIDOCAINE25MG+3MGPHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT.
P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT
EGYPTORAL TOPICAL LIQUIDS1.0X120.0 ML BOTTLE
1393NDA/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 BOTTLE
1394NDA/MAL/HDP/4801AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDDAZEL KITFLUCONAZOLE + AZITHROMYCIN + SECNIDAZOLE150MG + 1G + 1GAJANTA PHARMA LTD--B-4/5/6 MIDC INDUSTRIAL AREA PAITHAN 431 128 AURANGABADINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X4.0 TABLET BLISTER
1395NDA/MAL/HDP/4804DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDKIMSY MEDS LTDCLAVODARAMOXICILLIN + CLAVULANIC200MG + 28MG /5MLDAR AL DAWA-NA'UR PLANT AMMANJORDANORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X70.0 ML BOTTLE
1396NDA/MAL/HDP/4805AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOFENIBUPROFEN200MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
1397NDA/MAL/HDP/4806AGOG PHARMA LTDGITTOES 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 INDIAINDIAORAL SOLID ORDINARY COATED TABLETS1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER
1398NDA/MAL/HDP/4807AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOFORMINMETFORMIN500MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
1399NDA/MAL/HDP/4809AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOCORTHYDROCORTISONE0.1%W/WAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE
1400NDA/MAL/HDP/4810TATA UGANDA LIMITEDTATA UGANDA LIMITEDMETHYLERGONOVINEMETHYLERGONOVINE MALEATE0.2MG/MLGLAND PHARMA LTD -D.P.PALLY, DUNDIGAU POST NEAR GANDIMAISAMMA CROSS ROAD, QUTHBULLAPUR MANDAL, RANGA REDDY DISTRICT, HYDERABAD - 500043, ANDHRA PRADESHINDIAPARENTERAL ORDINARY AMPOULES1.0X10.0X1.0 ML AMPOULE
1401NDA/MAL/HDP/4811AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOGYLMETRONIDAZOLE200MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
1402NDA/MAL/HDP/4812AGOG PHARMA LTDGITTOES 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 INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE
1403NDA/MAL/HDP/4813AGOG PHARMA LTDGITTOES 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 INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X500.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER
1404NDA/MAL/HDP/4814EUROLIFE HEALTHCARE PVT LIMITEDAIVEEN (U) LIMITEDMETLIFEMETRONIDAZOLE500MG/100MLEUROLIFE HEALTHCARE PVT LTD-BHAGWANPUR ROAD, UTTARAKHANDINDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X100.0 ML BOTTLE
1405NDA/MAL/HDP/4815LABORATORY AND ALLIED LTDHARLEYS UGANDA LIMITEDFERROLIC-LFFERROUS SULPHATE +FOLIC ACID200MG+0.4MGLABORATORY & ALLIED LTD-PLOT NO. 209/10349
OFF MOMBASA ROAD, NAIROBI
P.O. BOX 42875, NAIROBI, KENYA.
KENYAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
1406NDA/MAL/HDP/4817CYANO PHARMA(P)RENE PHARMACY LTDMETOCLOPRAMIDE TABLETSMETOCLOPRAMIDE10MGCYANO PHARMA(P)-115-C IND ESTATE POLO GROUND INDOREINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
1407NDA/MAL/HDP/4818LABORATORY AND ALLIED LTDHARLEYS UGANDA LIMITEDFERROUS SULPHATEFERROUS SULPHATE200MGLABORATORY & ALLIED LTD-PLOT NO. 209/10349
OFF MOMBASA ROAD, NAIROBI
P.O. BOX 42875, NAIROBI, KENYA.
KENYAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
1408NDA/MAL/HDP/4819FDC LTDAIVEEN (U) LIMITEDORAL REHYDRATION SALTORAL REHYDRATION SALT27.9GMFDC LIMITED -B-8, M.I.D.C., INDUSTRIAL AREA, WALUJ – AURANGABAD- 431 136 MAHARASHTRA, INDIA. INDIAORAL LIQUID ORDINARY UNIT DOSE POWDERS1.0X27.9 G SACHET
1409NDA/MAL/HDP/4820IDAKIMSY MEDS LTDFERROUS SULPHATE+FOLIC ACIDFERROUS SULPHATE+FOLIC ACID200MG+0.4MGBIO NOVA PHARM LTD.-C-66/1 OKHLA INDUSTIAL AREA PHASE II NEW DEHLIINDIAORAL SOLID ORDINARY COATED TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
1410NDA/MAL/HDP/4821EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDMETPURE-XL 50METOPROLOL50MGEMCURE PHARMACEUTICALS LIMITED -LANE NO.3 PHASE II SIDCO INDUSTRIAL COMPLEX BARI-BRAHMANA JAMMU ,181133INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER
1411NDA/MAL/HDP/4823OTSUKA PHARMACEUTICAL INDIA PRIVATE LIMITEDREDDYS PHARMA LIMITEDMETRIS INFUSIONMETRONIDAZOLE5MG/MLOTSUKA PHARMACEUTICAL INDIA PRIVATE LTD-VILLAGE – VASANA – CHACHARWADIP, TAL: SANAND, AHMADABADINDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X100.0 ML BOTTLE
1412NDA/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 CONTAINER
1413NDA/MAL/HDP/4826UNIQUE PHARMACEUTICALS LTDTATA UGANDA LIMITEDMETROGYL DENTA GELMETRONIDAZOLE + CHLORHEXIDINE1%W/W + 0.25%W/WUNIQUE PHARMACEUTICAL LABORATORIES (A DIV. OF J.B CHEMICALS & PHARMACEUTICALS LTD)--216-219 GIDC INDUSTRIAL AREA PANOLI 394 116 DIST BHARUCHINDIAORAL TOPICAL GELS AND SOLS1.0X20.0 G TUBE
1414NDA/MAL/HDP/4828UNIQUE PHARMACEUTICALS LABORATORIESTATA UGANDA LIMITEDMETROGYL GELMETRONIDAZOLE1%W/WUNIQUE PHARMACEUTICAL LABORATORIES (A DIV. OF J.B CHEMICALS & PHARMACEUTICALS LTD)--304-308 GIDC INDUSTRIAL AREA PANOLI 394 116 DIST BHARUCHINDIATOPICAL EXTERNAL EMULSION GELS1.0X30.0 G TUBE
1415NDA/MAL/HDP/4830UNIQUE PHARMACEUTICALS LABORATORIESTATA UGANDA LIMITEDMETROGYL INJECTIONMETRONIDAZOLE5MG/MLUNIQUE PHARMACEUTICAL LABORATORIES, (A DIVISION OF J.B CHEMICALS & PHARMACEUTICALS LTD-PLOT NO 4, PHASE IV, GIDC INDUSTRIAL AREA, PANOLI 394 116,UNIQUE PHARMACEUTICAL LABORATORIES (A DIV. OF J.B CHEMICALS & PHARMACEUTICALS LTD)--304-308 GIDC INDUSTRIAL AREA PANOLI 394 116 DIST BHARUCHINDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X100.0 ML BOTTLE
1416NDA/MAL/HDP/4832UNIQUE PHARMACEUTICALS LABORATORIESTATA UGANDA LIMITEDMETROGYL SUSPENSIONMETRONIDAZOLE200MG/5MLUNIQUE PHARMACEUTICAL LABORATORIES-PLOT NO. 215-219, G.I.D.C. INDUSTRIAL AREA,PANOLI — 394 116, GUJARAT, INDIA.
,J.B. CHEMICALS AND PHARMACEUTICALS LTD .-128/1, GIDC, ANKLESHWAR 393 002, GUJARAT
INDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE
1417NDA/MAL/HDP/4836AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDMETRONMETRONIDAZOLE200MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
1418NDA/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-INDIAINDIARECTAL SYSTEMIC SUPPOSITORIES1.0X1.0X5.0 SUPPOSITORY BLISTER,1.0X2.0X5.0 SUPPOSITORY BLISTER
1419NDA/MAL/HDP/4840BEIJING HOLLEY COTEC PHARMA CHINASUPER PHARMACEUTICALS LIMITEDMETRONIDAZOLEMETRONIDAZOLE200MGSHANDONG XIER KANGTAI PHARMACEUTICALS CO. LTD PRIVATE-PRIVATE ECONOMY ZONE,XINYAN TOWN, YANZHOU DISTRICT, JINING CITY,SHANDONG,CHINA PRCHINAORAL SOLID ORDINARY TABLETS1.0X100.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
1420NDA/MAL/HDP/4845TORRENT PHARMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.ANTIDEPIMIPRAMINE25MGTORRENT PHARMACEUTICALS LTD-INDRAD-382 721, DIST.MEHSANA,INDIA.AT:VILL.MANAKPUR,TEH.NALAGARH,DIST.SOLAN(H.P.)INDIAORAL SOLID ORDINARY TABLETS10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
1421NDA/MAL/HDP/4854RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDMETROREN FCMETRONIDAZOLE200MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1000.0 TABLET CONTAINER
1422NDA/MAL/HDP/4855GLENMARK PHARMACEUTICALS LTDSTAR PHARMACEUTICALS LTDASCORIL EXPECTORANTBROMHEXINE+MENTHOL+TERBUTALINE+GUAIFENESIN2MG+0.5MG+1.25MG+50MGGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,DINDIAORAL LIQUID ORDINARY SYRUPS1.0X200.0 ML BOTTLE,1.0X100.0 ML BOTTLE
1423NDA/MAL/HDP/4856RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDMETRORENMETRONIDAZOLE200MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X20.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
1424NDA/MAL/HDP/4858RENE INDUSTRIESRENE INDUSTRIES LIMITEDMETROREN SUSPENSIONMETRONIDAZOLE BENZOATE200MG/5MLRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE
1425NDA/MAL/HDP/4859GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDFLOXAPENFLUCLOXACILLIN250MGSMITHLINE BEECHAM CLARENDON RD WORTHIN-CLARENDON RD WORTHING WEST SUSSEXUNITED KINGDOMORAL SOLID ORDINARY CAPSULES1.0X100.0 CAPSULE CARTON
1426NDA/MAL/HDP/4860KWALITY AFRO ASIA LIMITEDKWALITY AFRO ASIA LIMITEDK-FEN SUSPENSIONIBUPROFEN100MG/5MLKWALITY AFRO-ASIA LTD-PLOT 165 KAWEMPE BOMBO ROADUGANDAORAL LIQUID ORDINARY SUSPENSIONS1.0X60.0 ML BOTTLE
1427NDA/MAL/HDP/4863MEDICAL UNION PHARMACUITICALSKARURI PHARMACEUTICALS LTD.MICONAZ ORAL GELMICONAZOLE2%W/WMEDICAL UNION PHARMA .CO-ABU-SULTAN ISMAILIA EGYPTEGYPTORAL TOPICAL GELS AND SOLS1.0X20.0 G TUBE
1428NDA/MAL/HDP/4865MEDICAL UNION PHARMACUITICALSKARURI PHARMACEUTICALS LTD.MICONAZ CREAMMICONAZOLE NITRATE2%W/WMEDICAL UNION PHARMA .CO-ABU-SULTAN ISMAILIA EGYPTEGYPTVAGINAL CREAMS1.0X20.0 G TUBE
1429NDA/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 TUBE
1430NDA/MAL/HDP/4869CIPLA LIMITED.QUALITY CHEMICALS LTD - HUMANMICOGEL CREAMMICONAZOLE NITRATE2%W/WCIPLA LTD--PLOT NO L-139,VERNA IND ESTATE, VERNA GOA-403 INDIAINDIATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE
1431NDA/MAL/HDP/4870ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDFLUCASFLUCONAZOLE150MGASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIAINDIAORAL SOLID ORDINARY CAPSULES1.0X1.0 CAPSULE BLISTER
1432NDA/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 TUBE
1433NDA/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 INDIAINDIAORAL SOLID ORDINARY CAPSULES1.0X4.0 CAPSULE BLISTER
1434NDA/MAL/HDP/4874SANOFI-AVENTISLABOREX UGANDA LIMITEDCLEXANEENOXAPARIN SODIUM100MG/MLSANOFI WINTHROP INDUSTRIE--180 RUE JEAN JUARES BP 4094702 MAISON ALFORT CEDEXFRANCEPARENTERAL ORDINARY PRE-FILLED SYRINGES1.0X2.0X0.6 ML PRE- FILLED SYRINGE
1435NDA/MAL/HDP/4875PHARM ACCESS AFRICA LTDMARIE STOPES UGANDA LIMITEDMISOCLEARMISOPROSTOL200MCGACME FORMULATION PVT LTD,-ACME FORMULATION PVT LTD ROPAR ROAD NALAGARH DIST SOLAN HIMACHAL PRADESHINDIAORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER
1436NDA/MAL/HDP/4876SANOFI-AVENTISLABOREX UGANDA LIMITEDCLEXANEENOXAPARIN SODIUM100MG/MLSANOFI WINTHROP INDUSTRIE--180 RUE JEAN JUARES BP 4094702 MAISON ALFORT CEDEXFRANCEPARENTERAL ORDINARY PRE-FILLED SYRINGES1.0X2.0X0.8 ML PRE- FILLED SYRINGE
1437NDA/MAL/HDP/4877SANOFI-AVENTISLABOREX UGANDA LIMITEDCLEXANEENOXAPARIN SODIUM100MG/MLSANOFI WINTHROP INDUSTRIE--180 RUE JEAN JUARES BP 4094702 MAISON ALFORT CEDEXFRANCEPARENTERAL ORDINARY PRE-FILLED SYRINGES1.0X2.0X0.4 ML PRE- FILLED SYRINGE
1438NDA/MAL/HDP/4878EUROLIFE HEALTHCARE PVT LIMITEDAIVEEN (U) LIMITEDFLUCOLIFEFLUCONAZOLE200MG/100MLEUROLIFE HEALTHCARE PVT LTD-BHAGWANPUR ROAD, UTTARAKHANDINDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X100.0 ML BOTTLE
1439NDA/MAL/HDP/4879SANOFI-AVENTISLABOREX UGANDA LIMITEDCLEXANEENOXAPARIN SODIUM100MG/MLSANOFI WINTHROP INDUSTRIE--180 RUE JEAN JUARES BP 4094702 MAISON ALFORT CEDEXFRANCEPARENTERAL ORDINARY PRE-FILLED SYRINGES1.0X2.0X0.2 ML PRE- FILLED SYRINGE
1440NDA/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 BLISTER
1441NDA/MAL/HDP/4881ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDASDOXINDOXYCYCLINE100MGASTRA LIFE CARE(INDIA) PVT LTD-57/P, POJODA, 382220, BOVIA, AHMEDOBAD, INDIAINDIAORAL SOLID ORDINARY CAPSULES1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 TABLET BLISTER
1442NDA/MAL/HDP/4883ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDASFEN-FCIBUPROFEN200MGASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIAINDIAORAL SOLID ORDINARY TABLETS10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
1443NDA/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 INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER
1444NDA/MAL/HDP/4887DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDFLUCOZALFLUCONAZOLE200MGAEGIS LTD-17 ATHINON STREET, ERGATON INDUSTRIAL AREA, NICOSIA CYPRUSCYPRUSORAL SOLID ORDINARY CAPSULES1.0X10.0 CAPSULE BLISTER
1445NDA/MAL/HDP/4888ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDASOMYCINERYTHROMYCIN250MGASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER
1446NDA/MAL/HDP/4889DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDFLUCOZALFLUCONAZOLE50MGAEGIS LTD-17 ATHINON STREET, ERGATON INDUSTRIAL AREA, NICOSIA CYPRUSCYPRUSORAL SOLID ORDINARY CAPSULES1.0X14.0 CAPSULE BLISTER
1447NDA/MAL/HDP/4890DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDFLUCOZALFLUCONAZOLE100MGAEGIS LTD-17 ATHINON STREET, ERGATON INDUSTRIAL AREA, NICOSIA CYPRUSCYPRUSORAL SOLID ORDINARY CAPSULES1.0X10.0 CAPSULE BLISTER
1448NDA/MAL/HDP/4891REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDASPEC TABLETASPIRIN+PARACETAMOL+CAFFEINE ANHYDROUS150MG+250MG+300MGREGAL PHARMACEUTICALS LTD-OFF BABA DOGO RD, RUARAKA, NAIROBI, KENYAKENYAORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER
1449NDA/MAL/HDP/4892KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDFLUFED COUGH FORMULAMULTI-INGREDIENTMULTI-INGREDIENTKAMPALA PHARMECEUTICALS INDUSTRIES LTD.-PLOT M444B STRETCHER RD, NTINDA KLA UGANDAUGANDAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE
1450NDA/MAL/HDP/4893NAARI AG BASELECHO PHARMACY (U) LIMITEDMIFETRILMIFEPRISTONE200MGJAGSONPAL PHARMACEUTICALS LTD-PLOT NO.14-16,55-57,SECTOR-5,IIE PANT NAGAR,SIDCUL,RUDRAPUR UDHAM SINGH NAGAR,UTTARAKHAND-263153 INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X3.0 TABLET BLISTER
1451NDA/MAL/HDP/4901BAYER PHARMA AGSURGIPHARM (U) LIMITEDAVELOX IVMOXIFLOXACIN HCL400MG/250MLBAYER PHARMA AG -51368 LEVERKUSEN GERMANYGERMANYPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X250.0 ML BOTTLE
1452NDA/MAL/HDP/4903AGOG PHARMA LTD.GITTOES 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 INDIAINDIAORAL SOLID ORDINARY CHEWABLE TABLETS1.0X100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
1453NDA/MAL/HDP/4904NOVO NORDISKSTAR PHARMACEUTICALS LTDMIXTARD 30INSULIN HUMAN100 I.U/MLNOVO NORDISK PHARMA-NOVO ALLEDENMARKPARENTERAL ORDINARY S C VIALS1.0X10.0 ML VIAL
1454NDA/MAL/HDP/4905XEPA-SOUL PATTINSONDELMAW ENTERPRISES LIMITEDAVORAX CREAMACYCLOVIR5%W/WXEPA-SOUL PATTINSON (MALAYSIA) SDN BHD-1-5 CHENG INDUSTRIAL ESTATE, 75250
MALEKA, MALAYSIA
MALAYSIATOPICAL EXTERNAL CREAMS1.0X5.0 G TUBE
1455NDA/MAL/HDP/4908NOVO NORDISKSTAR PHARMACEUTICALS LTDMIXTARD 30 PENFILLBIPHASIC ISOPHANE INSULIN (HUMAN)100 I.U/MLNOVO NORDISK A/S - NOVO ALLE DK-2880 BAGSVAERDDENMARKPARENTERAL ORDINARY CARTRIDGES1.0X3.0 ML CARTRIDGE,1.0X1.5 ML CARTRIDGE
1456NDA/MAL/HDP/4909AXA PARENTERALS LTDGITTOES PHARMACEUTICALS 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 BOTTLE
1457NDA/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 BOTTLE
1458NDA/MAL/HDP/4911EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDMOFILET-500MYCOPHENOLATE MOFETIL500MGEMCURE PHARMACEUTICALS LIMITED -LANE NO.3 PHASE II SIDCO INDUSTRIAL COMPLEX BARI-BRAHMANA JAMMU ,181133INDIAORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER
1459NDA/MAL/HDP/4915FOURTS(INDIA) LABORATORIES PVT LTDDELMAW ENTERPRISES LIMITEDFOGYL-S TABLETSMETRONIDAZOLE200MGFOURTS (INDIA) LABORATORIES PRIVATE LIMITED -VANDALUR ROADINDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER
1460NDA/MAL/HDP/4918FOURTS(INDIA) LABORATORIES PVT LTDDELMAW ENTERPRISES LIMITEDFOGYL SUSPENSIONMETRONIDAZOLE BENZOATE200MG/5MLFOURTS (INDIA) LABORATORIES PRIVATE LIMITED -VANDALUR ROADINDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE
1461NDA/MAL/HDP/4920LEBEN LABORATORIES LTDANDYCO PHARMACY (UGANDA) LTDFOLIBENFOLIC ACID5MGLEBEN LAB PVT LTD-L4 PHASE 111 MIDCS AKOLA 444104 MAHARASTRA INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X20.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
1462NDA/MAL/HDP/4922KOPRAN LIMITEDTATA UGANDA LIMITEDCIPROQUIN-500CIPROFLOXACIN500MGKOPRAN LIMITED-VILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS10.0X10.0 TABLET BLISTER
1463NDA/MAL/HDP/4924AGOG PHARMA 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 INDIAINDIAORAL SOLID ORDINARY CHEWABLE TABLETS1.0X1000.0 TABLET CONTAINER
1464NDA/MAL/HDP/4926LABORATORY&ALLIED LTDHARLEYS UGANDA LIMITEDFOLIC ACIDFOLIC ACID5MGLABORATORY & ALLIED LTD-PLOT NO. 209/10349
OFF MOMBASA ROAD, NAIROBI
P.O. BOX 42875, NAIROBI, KENYA.
KENYAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
1465NDA/MAL/HDP/4927NORVATIS PHARMA AG- SWITZERLANDLABOREX UGANDA LIMITEDAZOPTBRINZOLAMIDE10MG/MLALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUMBELGIUMOPHTHALMIC SUSPENSIONS1.0X5.0 ML BOTTLE
1466NDA/MAL/HDP/4928AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITEDROYAL PHARMA 2011 LIMITEDFOLIC ACID TABLETSFOLIC ACID5MGAFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED-PLOT 9-12,DEWAN & SONS INDL. AREA, VEOOR,PALGHAR-401404. INDIA.
INDIAORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET STRIP,1.0X1000.0 TABLET CONTAINER
1467NDA/MAL/HDP/4929MARTINDALE AND AURUM PHARMACEUTICALLABOREX UGANDA LIMITEDMORPHINE INJECTIONMORPHINE15MG/MLMARTINDALE PHARMACEUTICAL LIMITED -BAMPTON ROAD RMM38UG ENGLANDUNITED KINGDOMPARENTERAL ORDINARY AMPOULES1.0X1.0 ML AMPOULE
1468NDA/MAL/HDP/4932MARTINDALE AND AURUM PHARMACEUTICALLABOREX UGANDA LIMITEDMORPHINE INJECTIONMORPHINE10MG/MLMARTINDALE PHARMACEUTICAL LIMITED -BAMPTON ROAD RMM38UG ENGLANDUNITED KINGDOMPARENTERAL ORDINARY AMPOULES1.0X1.0 ML AMPOULE
1469NDA/MAL/HDP/4933KAMPALA PHARMACEUTICAL INDUSTRIES LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDAZUDOXDOXYCYCLINE HYDROCHLORIDE100MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD -PLOT NO. M444B, STRETCHER ROAD, NTINDA, KAMPALA UGANDAORAL SOLID ORDINARY CAPSULES1.0X100.0 CAPSULE CONTAINER,1.0X10.0 CAPSULE BLISTER,1.0X500.0 CAPSULE CONTAINER,1.0X250.0 CAPSULE CONTAINER,1.0X1000.0 CAPSULE CONTAINER
1470NDA/MAL/HDP/4935GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDBACTROBAN OINTMENTMUPIROCIN2%W/WGLAXO OPERATIONS UK LTD -PRIORY STREET, WARE
HERTFORDSHIRE SG12 0DJ, UK
UNITED KINGDOMTOPICAL EXTERNAL OINTMENTS1.0X3.0 G TUBE,1.0X15.0 G TUBE
1471NDA/MAL/HDP/4936RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDCOMBIFENIBUPROFEN + PARACETAMOL400MG + 500MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER
1472NDA/MAL/HDP/4937JASSEN-CILAG (PTY) LTDLABOREX UGANDA LIMITEDMOTILIUMDOMPERIDONE10MGJANSSEN-CILAG-27 100 VAL DE REUIL, FRANCEFRANCEORAL SOLID ORDINARY FILM-COATED TABLETS1.0X20.0 TABLET CARTON,1.0X30.0 TABLET CARTON
1473NDA/MAL/HDP/4938GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDBACTROBAN CREAMMUPIROCIN2%W/WGLAXO OPERATIONS UK LTD -PRIORY STREET, WARE
HERTFORDSHIRE SG12 0DJ, UK
UNITED KINGDOMTOPICAL EXTERNAL CREAMS1.0X1.0X15.0 G TUBE
1474NDA/MAL/HDP/4939RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDFOLIRENFOLIC ACID5MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER
1475NDA/MAL/HDP/4940AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDFOLONFOLIC ACID5MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
1476NDA/MAL/HDP/4941GLAXO SMITH KLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDBEECHAMS POWDERS HOT LEMONPARACETAMOL+PHENYLEPHEDRINE600MG+10MGSMITHLINE BEECHAM (NAIROBI)-NAIROBI, KENYAKENYAORAL LIQUID ORDINARY SOLUBLE POWDERS1.0X48.0X5.6 G SACHET,1.0X5.0X5.6 G SACHET
1477NDA/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 BLISTER
1478NDA/MAL/HDP/4946ESAPHARMA S.R.L..BYAMAKA PHARMACEUTICAL COMPANY LTDMOVATECLOBETASOL0.05%W/WESAPHARMA S.R.L.VIA-VIA ALCIDE DE GASPERI, 23, MELZO MI, ITALY
ITALYTOPICAL EXTERNAL CREAMS1.0X30.0 G TUBE
1479NDA/MAL/HDP/4949JOHNSON&JOHNSON PTY LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDBENYLIN DRY COUGH DMDEXTROMETHORPHAN HYDROBROMIDE15MG/MLJOHNSON&JOHNSON PTY LTD.-EDMS BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICASOUTH AFRICAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE
1480NDA/MAL/HDP/4950DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDKIMSY MEDS LTDFORMIT 500METFORMIN500MGDAR AL DAWA-DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD. NA’UR PRINCE HASHEM BIN AL-HUSSEIN STREET. AMMAN, JORDANJORDANORAL SOLID ORDINARY FILM-COATED TABLETS1.0X5.0X10.0 TABLET BLISTER
1481NDA/MAL/HDP/4951JOHNSON&JOHNSON PTY LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDBENYLIN ORIGINALDIPHENHYDRAMINE HYDROCHLORIDE + AMMONIUM CHLORIDE12.5 MG/5ML + 125 MG/5MLJOHNSON&JOHNSON PTY LTD.-EDMS BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICASOUTH AFRICAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE,1.0X2.5 L BOTTLE
1482NDA/MAL/HDP/4952JOHNSON&JOHNSON PTY LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDBENYLIN WITH CODEINEDIPHENHYDRAMINE HCL + AMMONIUM CHLORIDE + CODEINE PHOSPHATE12.5MG/5ML +125MG/5ML +10MG/5MLJOHNSON&JOHNSON PTY LTD.-EDMS BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICASOUTH AFRICAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE
1483NDA/MAL/HDP/4953MEGA LIFESCIENCES (AUSTRALIA) PTY LTDSURGIPHARM (U) LIMITEDNAT-BMULTI-INGREDIENTMULTI-INGREDIENTMEGA LIFE SCIENCES PUBLIC COMPANY LIMITED-384 SOIB PATTANA 3 RD BANGPOO INDUSTRIAL ESTATE SAMUTPRAKARN 10280THAILANDORAL SOLID ORDINARY OTHER CAPSULES1.0X3.0X10.0 CAPSULE BLISTER
1484NDA/MAL/HDP/4956UNIQUE PHARMACEUTICALS LABORATORIESTATA UGANDA LIMITEDCONTRAPAQUE 30IOHEXOL350MGUNIQUE PHARMACEUTICAL LABORATORIES, (A DIVISION OF J.B CHEMICALS & PHARMACEUTICALS LTD-PLOT NO 4, PHASE IV, GIDC INDUSTRIAL AREA, PANOLI 394 116INDIAPARENTERAL ORDINARY VIALS1.0X50.0 ML VIAL
1485NDA/MAL/HDP/4957GLENMARK PHARMACUTICALS LTDSTAR PHARMACEUTICALS LTDMUMFERIRON (111) POLYMALTOSE COMPLEX + FOLIC ACID100MG + 500MCGGLENMARK PHARMACEUTICALS LTD PLOT E-PLOT NO. E-37, 39, MIDC AREA, SATPUR, NASIK - 422 007, MAHARASHTRAINDIAORAL SOLID ORDINARY CHEWABLE COATED TABLETS1.0X3.0X10.0 TABLET BLISTER
1486NDA/MAL/HDP/4958TROIKAA PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDBENZOSEDMIDAZOLAM1MG/ML TROIKAA PHARMACEUTICALS LTD .-SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHAND, INDIAINDIAPARENTERAL ORDINARY VIALS1.0X1.0X5.0 ML VIAL
1487NDA/MAL/HDP/4962SK AGE EXPORTSABACUS PHARMA (AFRICA) LIMITEDBETADBETAMETHASONE DIPROPRIONATE0.05%W/WS.KANT HEALTHCARE LTD-PLOT 1802, 1805, GIDC PHASE III VAPI 39179, GUJARATINDIATOPICAL EXTERNAL CREAMS1.0X1.0X30.0 G TUBE,1.0X1.0X15.0 G TUBE
1488NDA/MAL/HDP/4965BETA HEALTHCARE INTERNATIONAL LTDBETA HEALTHCARE UGANDA LIMITEDBETAFEN SYRUPIBUPROFEN100MG/5MLBETA HEALTHCARE INTERNATIONAL LTD - -PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYAKENYAORAL LIQUID ORDINARY SYRUPS1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE
1489NDA/MAL/HDP/4967MEDIPHARM SALES (E.A) LTDMEDIPHARM INDUSTRIES (E.A) LTDPIRITEX JUNIORMULTI-INGREDIENTMULTI-INGREDIENTMEDIPHARM INDUSTRIES (E.A) LTD-PLOT 65, KAKAJJO ROAD, BWEYOGEREREUGANDAORAL LIQUID ORDINARY SYRUPS1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE
1490NDA/MAL/HDP/4968GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDFRUSEMIDE INJECTIONFUROSEMIDE10MG/MLNINGBO DAHONGYING PHARMACEUTICAL CO.LTD-NO. 396 MINGZHU ROAD, HI-TECH PARK, NINGBO CITY ZHEJIANG PROVINCE, CHINACHINAPARENTERAL ORDINARY AMPOULES1.0X10.0X2.0 ML AMPOULE
1491NDA/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 CONTAINER
1492NDA/MAL/HDP/4972JOHNSON &JOHNSON (PTY) LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDCOOLMINT LISTERINEMENTHOL + ALCOHOL 95%0.02% + 4.58MLJOHNSON&JOHNSON PTY LTD.-EDMS BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICASOUTH AFRICAORAL LIQUID ORDINARY LIQUIDS1.0X250.0 ML CONTAINER,1.0X500.0 ML CONTAINER
1493NDA/MAL/HDP/4973MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDPERGOVERISFOLLITROPIN ALFA/LUTROPIN ALFA150 I.U/75 I.UMERCK SERONO S.A. (MSA) -1170 SUCCURSALE D’AUBONNE ZONE INDUSTRIELLE DE L’OURIETTAZ, SWITZERLANDSWITZERLANDPARENTERAL ORDINARY DRY VIALS1.0X1.0 ML VIAL + 1*1ML VIAL OF WFI
1494NDA/MAL/HDP/4974COSMOS LTDASTRA PHARMA (U) LIMITEDFRUSEMIDE TABLETS BP 40MGFUROSEMIDE40MGCOSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREAKENYAORAL SOLID ORDINARY TABLETS1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER
1495NDA/MAL/HDP/4976MEGA LIFESCIENCES (AUSTRALIA) PTY LTDABACUS PHARMA (AFRICA) LIMITEDPERGLIM 2GLIMEPIRIDE2MGINVENTIA HEALTHCARE PVT. LTD .-FI – FI /1 ADDITIONAL AMBERNATH(EAST) – 421 506,MAHARASHTRA DIST. THANE, INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER
1496NDA/MAL/HDP/4978REMEDICA LTDGOODMAN INTERNATIONAL LTDPERAZONEDEXAMETHASONE0.5MGREMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHARCYPRUSORAL SOLID ORDINARY TABLETS10.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CONTAINER
1497NDA/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 INDIAINDIAPARENTERAL ORDINARY AMPOULES1.0X10.0X10.0X2.0 ML AMPOULE
1498NDA/MAL/HDP/4982COSMOS LTDASTRA PHARMA (U) LIMITEDCOSMAG TABLETSMAGNESIUM TRISILICATE370MGCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBIKENYAORAL SOLID ORDINARY CHEWABLE TABLETS1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER
1499NDA/MAL/HDP/4983PT SAMBE FARMAMEDVIN PHARMA LIMITEDPELASTINIMIPENEM + CILASTATIN500MG + 500MGPT SANBE FARMA-JI LEUWIGAJAH I62 CIMINDI CIMAHI WEST JAVA INDONESIAINDONESIAPARENTERAL ORDINARY DRY VIALS1.0X1.0 G VIAL
1500NDA/MAL/HDP/4987CADILA PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.PYRAZINAMIDEPYRAZINAMIDE400 MGCADILA PHARMACEUTICALS LIMITED-1389,TRASAD ROAD, DHOLKA-382 225, AHMEDABAD GUJARAT STATE,INDIA.INDIAORAL SOLID ORDINARY TABLETS1.0X24.0X28.0 TABLET BLISTER
1501NDA/MAL/HDP/4990IDA FOUNDATIONKIMSY MEDS LTDCOTRIMOXAZOLESULFAMETHOXAZOLE + TRIMETHOPRIM800MG +160MGMEDOPHARM -34B INDUSTRIAL AREA MALUR 563130INDIAORAL SOLID ORDINARY TABLETS1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
1502NDA/MAL/HDP/4995ROYAL GROUPHARLEYS UGANDA LIMITEDGENTABACT EYE/EAR DROPSGENTAMYCIN SULPHATE0.3%W/VAHLCON PARENTERALS (I) LIMITED-SP-918,INDUSTRIAL AREA,PHASE III BHIWADI DIST, ALWAR (RAJASTHAN) INDIAINDIAOPHTHALMIC DROPS1.0X10.0 ML VIAL
1503NDA/MAL/HDP/4998MYLAN LABORATORIES LIMITED.NORVIK ENTERPRISES LIMITEDHYANLEVONORGESTREL0.03MGMYLAN LABORATORIES LIMITED.--PLOT NO. 1606-1609, SARIGAM INDUSTRIAL AREA, GIDC, SARIGAM, TAL-UMERGAM, DIST VALSAD, 396155, GUJARAT, INDIA.,MYLAN LABORATORIES LIMITED..-PLOT NO.20 & 21, PHARMEZ, SARKHEJ-BAVLA NATIONAL HIGHWAY NO. 08A, NEAR VILLAGE MATODA, TAL-SANAND, AHMEDABAD, GUJARAT, INDIA 382213INDIAORAL SOLID ORDINARY TABLETS1.0X28.0 TABLET BLISTER
1504NDA/MAL/HDP/4999UNIQUE PHARMACEUTICAL LABORATORIESTATA UGANDA LIMITEDPAMIDOL*370IOPAMIDOL755.3MG/MLUNIQUE PHARMACEUTICAL LABORATORIES, (A DIVISION OF J.B CHEMICALS & PHARMACEUTICALS LTD-PLOT NO 4, PHASE IV, GIDC INDUSTRIAL AREA, PANOLI 394 116INDIAPARENTERAL ORDINARY VIALS1.0X50.0 ML VIAL,1.0X1.0X100.0 ML VIAL
1505NDA/MAL/HDP/5001ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDGENTAMICIN INJECTIONGENTAMYCIN80MG/2MLZHEJIANG RUIXIN PHARMACEUTICAL CO. LTD-KAIFA ROAD, LISHUI, ZHEJIANG P.R OF CHINACHINAPARENTERAL ORDINARY AMPOULES1.0X10.0X10.0X2.0 ML AMPOULE
1506NDA/MAL/HDP/5002ELI-LILLY EXPORT SALABOREX UGANDA LIMITEDHUMALOG MIX 25INSULIN LISPRO + INSULIN LISPRO PROTAMINE 25I.U+75I.ULILLY FRANCE SA-FRANCEFRANCEPARENTERAL ORDINARY S C VIALS1.0X10.0 ML VIAL,1.0X5.0X3.0 ML CARTRIDGE
1507NDA/MAL/HDP/5004GLAXOSMITHKLINE LIMITED LIKONIBETA HEALTHCARE UGANDA LIMITEDCOFTA TABLETSMULTI-INGREDIENTN/AGLAXOSMITHKLINE LIMITED - -78392-00507, VIWANDANI LIKONI ROAD NAIROBI KENYA,BETA HEALTHCARE INTERNATIONAL LTD - -PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYAKENYAORAL SOLID ORDINARY LOZENGES1.0X100.0 TABLET CARTON,1.0X50.0 TABLET CARTON,1.0X150.0 TABLET CARTON
1508NDA/MAL/HDP/5005MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDCOLD GOPARACETAMOL+PHENYLEPHRINE HYDROCHLORIDE+CHLORPHENIRAMINE MALEATE+CAFFEINE325MG+10MG+2MG+30MGTORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506INDIAORAL SOLID ORDINARY TABLETS1.0X50.0X1.0X4.0 TABLET BLISTER
1509NDA/MAL/HDP/5009I CARE PHARMA LIMITEDVITACARE LTDGENTAMYCINGENTAMYCIN0.3%W/VGRAND PHARMACEUTICAL(CHINA) CO.LTD-NO.5 GUTIAN ROAD QIAOKOU DISTRICT WUHAN CITY HUBEI PROVINCECHINAOPHTHALMIC DROPS1.0X1.0X10.0 ML VIAL
1510NDA/MAL/HDP/5010XEPA SOUL PATTISON (M) SDN BHDDELMAW ENTERPRISES LIMITEDZARIN CREAMCLOTRIMAZOLE2%W/WXEPA-SOUL PATTINSON (MALAYSIA) SDA BHD-1-5, CHENG INDUSTRIAL ESTATE, 75250, MELAKA, MALAYSIAMALAYSIATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE
1511NDA/MAL/HDP/5012ROYAL GROUPHARLEYS UGANDA LIMITEDGENTAMICIN INJECTIONGENTAMYCIN SULPHATE40MG/MLGRAND PHARMACEUTICAL (CHINA) CO. LTD--LAKE ROAD NELL JINYINHU ECOLOGICAL PARKDONG XI HU DISTRICT, WUHAN, HEBEI PROVINCE.CHINAPARENTERAL ORDINARY AMPOULES1.0X100.0X2.0 ML AMPOULE
1512NDA/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 INDIAINDIAOPHTHALMIC DROPS1.0X10.0 ML VIAL
1513NDA/MAL/HDP/5014UNIQUE PHARMACEUTICAL LABORATORIESTATA UGANDA LIMITEDVERMOREX SUSPENSIONMEBENDAZOLE100MG/5MLJ.B CHEMICALS & PHARMACEUTICALS LTD-128/1 GIDC ANKLESHWAR 393 022 GUJARAT INDIA,UNIQUE PHARMACEUTICAL LABORATORIES (A DIV. OF J.B CHEMICALS & PHARMACEUTICALS LTD)-216-219 GIDC INDUSTRIAL AREA PANOLI 394 116 DIST BHARUCHINDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X30.0 ML BOTTLE
1514NDA/MAL/HDP/5015REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDCOLDCAP CAPSULESPHENYLEPHRINE HYDROCHLORIDE+CHLORPHENIRAMINE5MG+4MGREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL SOLID ORDINARY CAPSULES1.0X500.0 CAPSULE CONTAINER,1.0X1000.0 CAPSULE CONTAINER,1.0X8.0X12.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER,1.0X12.0 CAPSULE BLISTER,1.0X10.0 CAPSULE BLISTER
1515NDA/MAL/HDP/5017REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDCOLDCAP SYRUPPARACETAMOL+PROMETHAZINE HYDROCHLORIDE+CODEINE PHOSPATE+PSEUDOEPHEDRINE HYDROCHLORIDE120MG+6.5MG+5MG+25MGREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE
1516NDA/MAL/HDP/5018GLAXO WELLCOME (KENYA) LTDERIS LTDVENTOLINSALBUTAMOL100MCGGLAXO WELLCOME PRODUCTION.-ZONE INDUSTRIELLE NO.2 23, RUE LAVOISIER 27000 EVREUX,FRANCE.FRANCERECTAL SYSTEMIC METERED-DOSE PRESSURISED AEROSOLS1.0X200.0 METERED DOSE CANNISTER
1517NDA/MAL/HDP/5019EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDCOLOSPASMIN FORTEMEBEVERINE135MGEGYPTIAN INT.PHARMACEUTICAL INDUSTRIES CO (E.I.P.C.O)-EGYPTIAN INT.PHARMACEUTICAL INDUSTRIES CO (E.I.P.C.O)EGYPTORAL SOLID ORDINARY TABLETS1.0X20.0 TABLET BLISTER
1518NDA/MAL/HDP/5020GLAXO WELLCOME (KENYA) LTDERIS LTDVENTOLINSALBUTAMOL2MG/MLGLAXO WELLCOME EGYPT SAE.-EL SALAM CITY 11491, CAIROKENYAORAL LIQUID ORDINARY SYRUPS1.0X150.0 ML BOTTLE,1.0X100.0 ML BOTTLE
1519NDA/MAL/HDP/5021BAYER SCHERING PHARMA FRANCESURGIPHARM (U) LIMITEDCOMBINATION 3ETHINYL ESTRADIOL+ LEVONORGESTREL+FERROUS FUMARATE0.03MG+0.15MG+75MGDELPHARMA SAS ZONE INDUSTRIELLE -DELPHARMA SAS ZONE INDUSTRIELLE DE ROUBAIX EST RUE DE TOUFFLERS BP 50070 59452 LYS LEZLANNOY CEDEX / BAYER PHARMA AG BERLIN,BAYER PHARMA AG -13353 BERLIN GERMANY,BAYER WEIMAR GMBH UND CO. KG,-WEIMAR DEBEREINERSTRASSE 20, 99427 WEIMAR GERMANYFRANCEORAL SOLID ORDINARY TABLETS1.0X100.0X28.0 TABLET BLISTER
1520NDA/MAL/HDP/5025THE MENTHOLATUM COMPANY LTDHARLEYS UGANDA LIMITEDDEEP FREEZE COLD GELMENTHOL2%W/WTHE MENTHOLATUM COMPANY LTD, TWYFORD,-TWYFORD, BENKSHIRE, EUNITED KINGDOMTOPICAL EXTERNAL GELS AND SOLS1.0X35.0 G TUBE,1.0X50.0 G TUBE,1.0X100.0 G TUBE
1521NDA/MAL/HDP/5027PFIZER LAB LTDLABOREX UGANDA LIMITEDTERRA-CORTRILMULTI-INGREDIENTMULTI-INGREDIENTPFIZER PGM ORLEANS FRANCE-AVENUE DE CONCYR, F-450FRANCEOPHTHALMIC LIQUIDS1.0X10.0 ML BOTTLE,1.0X5.0 ML BOTTLE,1.0X4.0 ML BOTTLE
1522NDA/MAL/HDP/5028THE MENTHOLATUM COMPANY LTD TWYHARLEYS UGANDA LIMITEDDEEP HEAT SPRAYMULTI-INGREDIENTMULTI-INGREDIENTTHE MENTHOLATUM COMPANY LTD, TWYFORD,-1 REDWOOD AVENUE, PEEL PARK CAMPUS EAST KILBRIDE, G74 SCOTLANDUNITED KINGDOMTOPICAL EXTERNAL PRESSURISED AEROSOLS1.0X150.0 ML CANNISTER
1523NDA/MAL/HDP/5030PFIZER LAB LTDLABOREX UGANDA LIMITEDSOLU-MEDROLMETHYLPREDNISOLONE HEMISUCCINATE125MG/2MLPFIZER GLOBAL MANUFACTURING BELGIUM NV-RIJKSWEG 12, 2870 PUURS - BELGIUMBELGIUMPARENTERAL ORDINARY DRY VIALS1.0X2.0 ML VIAL,1.0X8.0 ML VIAL
1524NDA/MAL/HDP/5031THE MENTHOLATUM COMPANY LTDHARLEYS UGANDA LIMITEDDEEP HEAT RUBMULTI-INGREDIENTMULTI-INGREDIENTTHE MENTHOLATUM COMPANY LTD, TWYFORD,-1 REDWOOD AVENUE, PEEL PARK CAMPUS EAST KILBRIDE, G74 SCOTLANDUNITED KINGDOMTOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE,1.0X35.0 G TUBE,1.0X67.0 G TUBE,1.0X100.0 G TUBE
1525NDA/MAL/HDP/5032REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDDELASED DRY COUGH SYRUP (NON DROWSY)DEXTROMETHORPHAN7.5MG/5MLREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE
1526NDA/MAL/HDP/5033FOURRTS(INDIA) LABORATORIES PVT.LIMITEDDELMAW ENTERPRISES LIMITEDMEBFIL TABLETSMEBENDAZOLE100MGFOURRTS(INDIA) LABORATORIES PVT.LIMITED-VANDALUR ROAD,KELAMBAKKAM-603 103,
TAMIL NADU,INDIA
INDIAORAL SOLID ORDINARY CHEWABLE TABLETS1.0X1000.0 TABLET CONTAINER
1527NDA/MAL/HDP/5035ABACUS PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDMEBENDAZOLEMEBENDAZOLE100MG/5MLMEDICAMEN BIOTECH LTD - -SP-1192 A&B PHASE IV INDUSTRIAL AREA BHIWADI 301019 DIST. ALWAR (RAJASTHAN) - INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X30.0 ML BOTTLE
1528NDA/MAL/HDP/5038UNICHEM LABORATORIES LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDM-CAM TABLETSMELOXICAM15MGUNICHEM LABORATORIES LIMITED-UNICHEM LABORATORIES LIMITED. UNIT II, VILLAGE BHATAULI KALAN, BADDI, DIST. SOLAN PIN CODE 173 205, HIMACHAL PRADESH, INDIA

INDIAORAL SOLID ORDINARY TABLETS1.0X4.0X5.0X10.0 TABLET BLISTER
1529NDA/MAL/HDP/5039MEGA LIFESCIENCES (AUSTRALIA) PTY LTDSURGIPHARM (U) LIMITEDGILOBAGINKO BILOBA EXTRACT40MGMEGA LIFE SCIENCES LIMITED-: PLANT I : 384 SOI 6, PATTANA 3 ROAD, BANGPOO INDUSTRIAL ESTATE, SAMUTPRAKAN 10280, THAILAND THAILANDORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER
1530NDA/MAL/HDP/5040PFIZER LABORATORIES (PTY) LTD BELGIUMLABOREX UGANDA LIMITEDDEPO-MEDROLMETHYLPREDNISOLONE ACETATE40MG/MLPFIZER GLOBAL MANUFACTURING BELGIUM NV-RIJKSWEG 12, 2870 PUURS - BELGIUMBELGIUMPARENTERAL ORDINARY VIALS1.0X1.0 ML VIAL,1.0X2.0 ML VIAL,1.0X5.0 ML VIAL
1531NDA/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 BELGIUMBELGIUMOPHTHALMIC OINTMENTS1.0X3.5 G TUBE
1532NDA/MAL/HDP/5042COSMOS LTDASTRA PHARMA (U) LIMITEDCOSATRIM DS TABLETSCO-TRIMOXAZOLE960MGCOSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREAKENYAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X500.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER
1533NDA/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 BELGIUMBELGIUMOPHTHALMIC DROPS1.0X5.0 ML BOTTLE
1534NDA/MAL/HDP/5044PFIZER LABORATORIES (PTY) LTD BELGIUMLABOREX UGANDA LIMITEDDEPO-PROVERAMEDROXYPROGESTERONE ACETATE150MG/MLPFIZER GLOBAL MANUFACTURING BELGIUM NV-RIJKSWEG 12, 2870 PUURS - BELGIUMBELGIUMPARENTERAL ORDINARY I M VIALS1.0X3.5 ML VIAL,1.0X1.0 ML VIAL
1535NDA/MAL/HDP/5047VHB MEDI SCIENCES LTDLLOYDS PHARMACY UGANDA LTD.MAXINEM 500MGMEROPENEM500MGVHB MEDI SCIENCES LTD-PLOT 20, 21, 22 & 49,50, 51. INTEGRATED INDUSTRIAL AREA SECTOR 5, RUDRAPUR, UTTARAKHAND - INDIAINDIAPARENTERAL ORDINARY DRY VIALS1.0X500.0 MG VIAL
1536NDA/MAL/HDP/5048VHB MEDI SCIENCES LTDLLOYDS PHARMACY UGANDA LTD.MAXINEM 1GMEROPENEM1GVHB MEDI SCIENCES LTD-PLOT 20, 21, 22 & 49,50, 51. INTEGRATED INDUSTRIAL AREA SECTOR 5, RUDRAPUR, UTTARAKHAND - INDIAINDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0 G VIAL
1537NDA/MAL/HDP/5050NORVATIS PHARMA AG- SWITZERLANDLABOREX UGANDA LIMITEDMAXIDEXDEXAMETHASONE0.1%W/VALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUMBELGIUMOPHTHALMIC DROPS1.0X5.0 ML BOTTLE
1538NDA/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 382210INDIALUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER1.0X200.0 METERED DOSE CANNISTER
1539NDA/MAL/HDP/5052CADILA PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.GLAMIDE TABLETSGLIBENCLAMIDE5 MGLA-MED HEALTHCARE PVT LTD-1389 TRASAD ROAD, DHOLKA, AHMEDABAD, GUJARAT INDIAINDIAORAL SOLID ORDINARY TABLETS2.0X50.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER
1540NDA/MAL/HDP/5054SANOFI AVENTIS KENYA LTDLABOREX UGANDA LIMITEDMAALOXMAGNESIUM HYDROXIDE + ALUMINIUM HYDROXIDE200MG + 200MGWINTHROP PHARMACEUTICALS (PTY) LTD.-PLOT NO.315 WALTLOO ROAD,PRETORIA,0186PRETORIA-PRIVATE BAG X516,SILVERTON,0127,SOUTH AFRICASOUTH AFRICAORAL SOLID ORDINARY CHEWABLE TABLETS1.0X10.0 TABLET BLISTER,1.0X5.0X10.0 TABLET BLISTER
1541NDA/MAL/HDP/5055GLAXOSMITHKLINE LTD UKERIS LTDDERMOVATECLOBETASOL PROPIONATE0.05%W/WGLAXOSMITHKLINE HARMIRE -GLAXOSMITHKLINE HARMIRE ROAD BARNARD CASTLE DURHAMUNITED KINGDOMTOPICAL EXTERNAL OINTMENTS1.0X30.0 G TUBE,1.0X25.0 G TUBE
1542NDA/MAL/HDP/5056AVENTIS PHARMA (PTY) LTD SOUTH AFRICALABOREX UGANDA LIMITEDMAALOX SUSPENSIONMAGNESIUM HYDROXIDE + ALUMINIUM HYDROXIDE665MG/5ML + 200MG/5MLWINTHROP PHARMACEUTICALS (PTY) LTD.-PLOT NO.315 WALTLOO ROAD,PRETORIA,0186PRETORIA-PRIVATE BAG X516,SILVERTON,0127,SOUTH AFRICASOUTH AFRICAORAL LIQUID ORDINARY SUSPENSIONS1.0X350.0 ML BOTTLE,1.0X150.0 ML BOTTLE,1.0X100.0 ML BOTTLE,1.0X500.0 ML BOTTLE
1543NDA/MAL/HDP/5057SANOFI AVENTIS KENYA LTDLABOREX UGANDA LIMITEDMAALOX PLUSMAGNESIUM HYDROXIDE + ALUMINIUM HYDROXIDE + SIMETHICONE200MG + 200MG + 25MGWINTHROP PHARMACEUTICALS (PTY) LTD.-PLOT NO.315 WALTLOO ROAD,PRETORIA,0186PRETORIA-PRIVATE BAG X516,SILVERTON,0127,SOUTH AFRICASOUTH AFRICAORAL SOLID ORDINARY CHEWABLE TABLETS1.0X4.0X10.0 TABLET BLISTER
1544NDA/MAL/HDP/5059AVENTIS PHARMA (PTY) LTD SOUTH AFRICALABOREX UGANDA LIMITEDMAALOX PLUS SUSPENSIONMAGNESIUM HYDROXIDE + ALUMINIUM HYDROXIDE665MG/5ML + 200MG/5MLWINTHROP PHARMACEUTICALS (PTY) LTD.-PLOT NO.315 WALTLOO ROAD,PRETORIA,0186PRETORIA-PRIVATE BAG X516,SILVERTON,0127,SOUTH AFRICASOUTH AFRICAORAL LIQUID ORDINARY SUSPENSIONS1.0X350.0 ML BOTTLE,1.0X150.0 ML BOTTLE,1.0X100.0 ML BOTTLE,1.0X500.0 ML BOTTLE
1545NDA/MAL/HDP/5061TATA UGANDA LIMITEDTATA UGANDA LIMITEDMAGNESIUM SULPHATEMAGNESIUM SULPHATE50MG/MLGLAND PHARMA LIMITTED 143-148-SURVEY NOS. 143-148, 150&151, NEAR GANDIMAISAMMA CROSS ROADS. RANGA REDDY DISTRICT HYDERABAD 500043INDIAPARENTERAL ORDINARY AMPOULES1.0X5.0X5.0 ML AMPOULE
1546NDA/MAL/HDP/5062EUROLIFE HEALTHCARE PVT LIMITEDAIVEEN (U) LIMITEDMANNILIFEMANNITOL20MG/100MLEUROLIFE HEALTHCARE PVT LTD-BHAGWANPUR ROAD, UTTARAKHANDINDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X100.0 ML BOTTLE
1547NDA/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 AMPOULE
1548NDA/MAL/HDP/5068GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDDEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATE8MG/2MLNINGBO DAHONGYING PHARMACEUTICAL CO LTD.-NO. 3986, HI-TECH PARK MINZHU ROAD, NINGBO CITY, ZHEJIANGCHINAPARENTERAL ORDINARY AMPOULES1.0X10.0X2.0 ML AMPOULE
1549NDA/MAL/HDP/5070EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDLOMOH-60ENOXAPARIN SODIUM60MG/0.6MLEMCURE PHARMACEUTICALS LTD -PLOT NO. P-1 ITBT PARK PHASE II MIDC HINJWADI PUNE 411057INDIAPARENTERAL ORDINARY PRE-FILLED SYRINGES1.0X1.0 ML PRE- FILLED SYRINGE
1550NDA/MAL/HDP/5071EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDLOMOH-40ENOXAPARIN SODIUM40MG/0.4MLEMCURE PHARMACEUTICALS LTD -PLOT NO. P-1 ITBT PARK PHASE II MIDC HINJWADI PUNE 411057INDIAPARENTERAL ORDINARY PRE-FILLED SYRINGES1.0X1.0 ML PRE- FILLED SYRINGE
1551NDA/MAL/HDP/5072CYANO PHARMA(P)RENE PHARMACY LTDDEXAMETHASONE TABLETSDEXAMETHASONE0.5MGCYANO PHARMA(P)-115-C IND ESTATE POLO GROUND INDOREINDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER
1552NDA/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, RAJASTHANINDIAOPHTHALMIC DROPS1.0X5.0 ML BOTTLE,1.0X2.5 ML BOTTLE
1553NDA/MAL/HDP/5074CADILA HEALTH CARE LTDABACUS PHARMA (AFRICA) LIMITEDDEXONA INJECTIONDEXAMETHASONE DISODIUM PHOSPHATE4MG/MLCADILA HEALTH CARE LTD-SARKHEJ BAVLA N.H NO. 8A MORAIJA, TAL, SANARD, AHMEDAD 382210, INDIAINDIAPARENTERAL ORDINARY VIALS1.0X2.0 ML VIAL
1554NDA/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 STRIP
1555NDA/MAL/HDP/5078NABIQASIM INDUSTRIES (PVT) LTD.JEET PHARMACEUTICALS LIMITEDGLANDIN E2 VAGINALDINOPROSTONE3MGNABIQASIM INDUSTRIES (PVT) LIMITED-17/24, KORANGI INDUSTRIAL AREA, KARACHI, PAKISTANPAKISTANVAGINAL TABLETS1.0X1.0 TABLET STRIP
1556NDA/MAL/HDP/5079GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDGLEMONT CT 5MONTELUKAST5MGGLENMARK PHARMACEUTICALS LTD-VILLAGE: KISHANPURA, BADDI NALAGARH DISTRICT SOLAN - 174101, INDIAINDIAORAL SOLID ORDINARY CHEWABLE TABLETS1.0X10.0X10.0 TABLET BLISTER
1557NDA/MAL/HDP/5080GENO PHARMACEUTICALS PVT LTDHARLEYS UGANDA LIMITEDLOBAKDICLOFENAC/PARACETAMOL/CHLORZOXAZONE50MG/325MG/250MGGENO PHARMACEUTICALS LTD--PHARMACEUTICAL COMPLEX, TIVIM INDUSTRIAL ESTATE, P.O. KARASWADA, MAPUSA, GOA 403526INDIAORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER
1558NDA/MAL/HDP/5086FOURRTS (INDIA) LABORATORIES PVT LTDDELMAW ENTERPRISES LIMITEDGLIFIL M FORTGLIBENCLAMIDE + METFORMIN HYDROCHLORIDE5MG+500MGFOURRTS(INDIA) LABORATORIES PVT.LIMITED-VANDALUR ROAD,KELAMBAKKAM-603 103,
TAMIL NADU,INDIA
INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER
1559NDA/MAL/HDP/5087PHARCO PHARMACEUTICALSWIDE SPECTRUM ENTERPRISES (U) LIMITEDDIABEN TABLETSGLIBENCLAMIDE5MGPHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT.
P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT
EGYPTORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER
1560NDA/MAL/HDP/5092MICRO LABS LTD 92 SIPCOTPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDDIAPRIDEGLIMEPIRIDE2MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER
1561NDA/MAL/HDP/5095MICRO LABS LTDLABOREX UGANDA LIMITEDDIAPRIDE PLUSGLIMEPIRIDE + METFORMIN1MG + 500MGMICRO LABS LTD 92 SIPCOT -92 SIPCOT HOSUR 635 126 TAMIL NADUINDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER
1562NDA/MAL/HDP/5097EUROLIFE HEALTHCARE PVT LIMITEDAIVEEN (U) LIMITEDGLUCOLIFEGLUCOSE5%W/VEUROLIFE HEALTHCARE PVT LTD-BHAGWANPUR ROAD, UTTARAKHANDINDIAPARENTERAL ORDINARY INFUSION DRY VIALS/BOTTLES1.0X100.0 ML BOTTLE
1563NDA/MAL/HDP/5098RIVA PHARMA FREE ZONEWIDE SPECTRUM ENTERPRISES (U) LIMITEDDIARIVDI-IODO HYDROXYQUINOLINE/ PHTHALYL SULPHATHIAZOLE/ HOMATROPINE / STREPTOMYCIN125MG/ 150MG/ 1MG/ 100MGRIVA PHARMA FREE ZONE-NASR CITY CAIRO EGYPTEGYPTORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X60.0 ML BOTTLE
1564NDA/MAL/HDP/5099COSMOS LTDASTRA PHARMA (U) LIMITEDGLUCOMETMETFORMIN500MGCOSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREAKENYAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER
1565NDA/MAL/HDP/5100LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDL-GENTAGENTAMICIN0.3%W/VLINCOLN PHARMACEUTICALS LTD--TRIMUL ESTATE AFER VODSAR VILLAGE KHATJAT 382 721 GUJARAT VADSAR P.O.J TALUKA KALOH DIST GANDHINAGAR INDIAINDIAOPHTHALMIC DROPS1.0X10.0 ML VIAL
1566NDA/MAL/HDP/5102MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDGLUCOPHAGE 500MGMETFORMIN500MGMERCK SANTÉ-2, RUE DU PRESSOIR VERT F 45400, SEMOY,NKUNZI PHARMACEUTICALS (PTY) LTD.-259 DAVIDSON ROAD CNR PEDDIE STREET, WADEVILLE EST. 1 GERMISTON 1422FRANCEORAL SOLID ORDINARY FILM-COATED TABLETS1.0X500.0 TABLET CONTAINER,1.0X6.0X15.0 TABLET BLISTER,1.0X30.0 TABLET BLISTER
1567NDA/MAL/HDP/5103MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDGLUCOPHAGE 1000MGMETFORMIN1000MGNKUNZI PHARMACEUTICALS (PTY) LTD --259 DAVIDSON ROAD, WADEVILLE, EXT 1, GERMINSTON, SOUTH AFRICAFRANCEORAL SOLID ORDINARY FILM-COATED TABLETS1.0X4.0X15.0 TABLET BLISTER
1568NDA/MAL/HDP/5104NOVO NORDISK PHARMA GULF FZ-LCPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDLEVEMIR FLEXPENINSULIN DETEMIR100 I.U/MLNOVO NORDISK A/S - NOVO ALLE DK-2880 BAGSVAERDDENMARKPARENTERAL ORDINARY PRE-FILLED PENS1.0X5.0X3.0 ML PREFILLED PEN
1569NDA/MAL/HDP/5106ESAPHARMA S.R.L..BYAMAKA PHARMACEUTICAL COMPANY LTDLEMONVATE CREAMCLOBETASOL PROPIONATE0.05%W/WESAPHARMA S.R.L.VIA-VIA ALCIDE DE GASPERI, 23, MELZO MI, ITALY
ITALYTOPICAL EXTERNAL CREAMS1.0X30.0 G TUBE
1570NDA/MAL/HDP/5107RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDINDOREN CAPSULESINDOMETHACIN25MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL SOLID ORDINARY CAPSULES10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER
1571NDA/MAL/HDP/5109LEBEN LABORATORIES PVT LTDANDYCO PHARMACY (UGANDA) LTDLEBASMA ORAL SOLUTIONSALBUTAMOL2MG/5MLLEBEN LAB PVT LTD-L4 PHASE 111 MIDCS AKOLA 444104 MAHARASTRA INDIAINDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE
1572NDA/MAL/HDP/5112WIN-MEDICARE PVT LTDSURGIPHARM (U) LIMITEDDICLOMOL SR TABLETSDICLOFENAC SODIUM100MGWIN MEDICARE PVT LIMITED-MEERUT, MUZAFFARNAGER ROAD, MODIPURAM – 250110, UTTAR PRADESH -INDIAINDIAORAL SOLID RETARD TABLETS1.0X10.0X10.0 TABLET BLISTER
1573NDA/MAL/HDP/5114NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDLATONE MULTIVITAMINMULTIVITAMINMULTI-INGREDIENTNEM LABORATORIES PVT LTD-NEM LABORATORIES PVT LTD, 133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAIINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER
1574NDA/MAL/HDP/5115AGOG PHARMA LTD.GITTOES PHARMACEUTICALS LIMITEDINDOS-25(THANE)INDOMETHACIN25MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY CAPSULES1000.0 CAPSULE CONTAINER,20.0X5.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER
1575NDA/MAL/HDP/5117VENUS REMEDIES LIMITEDHARLEYS UGANDA LIMITEDLASTINEMIMIPENEM + CILASTATIN500MG + 500MGVENUS REMMEDIES-UNIT II HILLTOP INDUSTRIAL ESTATES JHARMAJRI EPIP PHASE 1 BHOTOLI KALA BADDI INDIAINDIAPARENTERAL ORDINARY DRY VIALS1.0X10.0 ML VIAL
1576NDA/MAL/HDP/5119FOURRTS(INDIA) LABORATORIES PVT.LIMITEDDELMAW ENTERPRISES LIMITEDKONTRAC 200MISOPROSTOL200MCGFOURRTS INDIA LABORATORIES PVT. LIMITED-VANDALUR ROAD, KELAMBAKKAM 603103, CHENNAI, TAMIL NADU, INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X1.0X2.0 TABLET STRIP,1.0X10.0X10.0 TABLET BLISTER
1577NDA/MAL/HDP/5120REMEDICA LTDGOODMAN INTERNATIONAL LTDGLYFORMIN 500 TABLETSMETFORMIN500MGREMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHARCYPRUSORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER
1578NDA/MAL/HDP/5121UNIQUE PHARMACEUTICALS LABORATORIESTATA UGANDA LIMITEDDICLORAN GELDICLOFENAC DIETHYLAMMONIUM1%W/WUNIQUE PHARMACEUTICALS LABS ( A DIV OF J.B CHEMICALS & PHARMACEUTICAL LTD)--304-308 ,GIDC , PANOLI 394116INDIATOPICAL EXTERNAL GELS AND SOLS1.0X50.0 G TUBE,1.0X20.0 G TUBE
1579NDA/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 BOTTLE
1580NDA/MAL/HDP/5123REMEDICA LTDGOODMAN INTERNATIONAL LTDGLYFORMIN 850 TABLETSMETFORMIN850MGREMEDICA LIMITED -AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUSCYPRUSORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER
1581NDA/MAL/HDP/5124GLAXOSMITHKLINE LTD BELGIUMERIS LTDINFANRIX-HEXADIPHTHERIA + PERTUSSIS + BORDETELLA/PERTUSSIS + PERTUSSIS + HAEMAGGLUTININ + PERTACTIN + (HEPATITIS B/POLIOVIRUS TYPE 1 +2 +3)NLT 30 IU + NLT 40IU + 25MCG + 25MCG + 8MCG + 10MCG + (TYPE I 40D +TYPE 2 + TYPE 3)GLAXOSMITHKLINE BOILOGICALS-S.A RUE DE I'INSTITUT 89 B-1330 RIXENSARTBELGIUMPARENTERAL ORDINARY COMBINATION PACK VIALS1.0X0.5 ML VIAL (1 DOSE)
1582NDA/MAL/HDP/5125MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDGLYGESIC FORTE RHUMETIC CREAMMULTI INGREDIENTN/ATORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506INDIATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE
1583NDA/MAL/HDP/5126UNIVERSAL CORPORATION LTDDELMAW ENTERPRISES LIMITEDKNAC-75DICLOFENAC75MGUNIVERSAL CORPORATION LIMITED -PLOT 13777 KIKUYU ROAD, KIKUYU TOWN, PAST POST OFFICEKENYAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER
1584NDA/MAL/HDP/5127UNIQUE PHARMACEUTICALS LABORATORIESTATA UGANDA LIMITEDDICLORAN INJECTIONDICLOFENAC SODIUM25MG/MLUNIQUE PHARMACEUTICALS LABS ( A DIV OF J.B CHEMICALS & PHARMACEUTICAL LTD)--304-308 ,GIDC , PANOLI 394116INDIAPARENTERAL ORDINARY AMPOULES1.0X100.0X3.0 ML AMPOULE,1.0X5.0X3.0 ML AMPOULE
1585NDA/MAL/HDP/5128MEDIPHARM SALES LTDABACUS PHARMA (AFRICA) LIMITEDGOFEN 400 CLEARCAPIBUPROFEN400MGMEGA LIFESCIENCES LTD.-384 PATTANA 3 ROAD BANGPOO INDUSTRIAL ESTATE SUMUTPRAKANTHAILANDORAL SOLID ORDINARY CAPSULES6.0X1.0X10.0 CAPSULE BLISTER
1586NDA/MAL/HDP/5129NABIQASIM INDUSTRIES (PVT) LTD.JEET PHARMACEUTICALS LIMITEDKLEEN ENEMADISODIUM BISPHOSPHATE/ SODIUM PHOSPHATE19.2G+7.2G/ 120MLNABIQASIM INDUSTRIES (PVT) LIMITED-17/24, KORANGI INDUSTRIAL AREA, KARACHI, PAKISTANPAKISTANRECTAL SYSTEMIC ENEMA LIQUIDS1.0X135.0 ML BOTTLE
1587NDA/MAL/HDP/5130UNIQUE PHARMACEUTICALS LTDTATA UGANDA LIMITEDDICLORAN MS GELDICLOFENAC+METHYL SALICYLATE+MENTHOL1%W/W+10%W/W+5%W/WUNIQUE PHARMACEUTICALS LABS ( A DIV OF J.B CHEMICALS & PHARMACEUTICAL LTD)--304-308 ,GIDC , PANOLI 394116INDIATOPICAL EXTERNAL GELS AND SOLS1.0X30.0 G TUBE
1588NDA/MAL/HDP/5131NOVO NORDISKSTAR PHARMACEUTICALS LTDINSULATARD HMISOPHANE INSULIN (HUMAN)100 I.U/MLNOVO NORDISK PHARMA-NOVO ALLEDENMARKPARENTERAL ORDINARY S C VIALS1.0X10.0 ML VIAL
1589NDA/MAL/HDP/5132REMEDICA LTDGOODMAN INTERNATIONAL LTDKETROZOL 200 TABLETSKETOCONAZOLE200MGREMEDICA LIMITED,-LIMASSOL INDUSTRIAL ESTATE, AHARNON ST, P.O. BOX 51706,3508 LIMASSOLCYPRUSORAL SOLID ORDINARY TABLETS10.0X10.0 TABLET BLISTER
1590NDA/MAL/HDP/5133MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDGONAL-F PEN 900IU/1.5ML(66MCG/1.5ML)FOLLITROPIN ALFA66MCG/1.5MLMERCK SERONO S.A. (MSA) -1170 SUCCURSALE D’AUBONNE ZONE INDUSTRIELLE DE L’OURIETTAZ, SWITZERLANDSWITZERLANDPARENTERAL ORDINARY PRE-FILLED PENS1.