National Drug Register of Uganda - Human Medicines - August 2020 PDF

NATIONAL DRUG REGISTER OF UGANDA HUMAN MEDICINES AUGUST 2020
LOCAL
NDA GENERIC COUNTRY OF
LICENSE TECHNICAL NAME OF STRENGTH DOSAGE REGISTRATIO
S/N REGISTRATIO NAME OF MANUFACTURER MANUFACTU PACK SIZE
HOLDER REPRESENTATIV DRUG OF DRUG FORM N DATE
N NUMBER DRUG RE
E
1 NDA/MAL/H INGELHEIM SURGIPHARM MICARDIS TELMISARTA 40MG BOEHRINGER INGELHEIM GERMANY ORAL SOLID 1.0X4.0X7 7/1/1997
DP/0001 PHARMACEUT (U) LIMITED 40 N PHARMA GMBH & CO. ORDINARY .0 TABLET
ICAL LTD KG.,-BIRKENDORFER TABLETS BLISTER
STRASSE 65, 88397,
BIBERACH AN DER RISS
2 NDA/MAL/H ABACUS ABACUS X-SONE-N DEXAMETHAS 0.1W/V+ ABACUS PARENTERAL UGANDA OPHTHALMI 1.0X10.0 7/1/2011
DP/0002 PARENTERAL PARENTERAL ONE+NEOMY 0.35W/V DRUGS LTD.-PLOT NO. C DROPS ML
DRUGS DRUGS LIMITED CIN 114, BLOCK 191, VIAL,1.0X
LIMITED. GWAGAMYA, KINGA, 5.0 ML
KAPEKE, VIAL
MUKONO
3 NDA/MAL/H UNI MEDICO SHREEJI UMOXIL AMOXICILLIN 500 MG + UNI MEDICOLABS-21-22 INDIA ORAL SOLID 1.0X2.0X7 7/1/2015
DP/0003 LAB PHARMACEUTIC CLAV 625 + 125 MG PHARMACITY SELAQUI ORDINARY .0 TABLET
ALS LIMITED CLAVULANAT DEHRADUN 248197 FILM- BLISTER
E POTASSIUM COATED
TABLETS
4 NDA/MAL/H HOVID BHD UNITED DIAMIDE GLIBENCLAMI 5MG + HOVID BHD (IPOH SITE)- MALAYSIA ORAL SOLID 1.0X10.0X 7/1/2014
DP/0006 HEALTHCARE DE + 500MG 121 ,JALAN TUNKU ABDUL ORDINARY 12.0
DISTRIBUTORS METFORMIN RAHMAN , 30010 IPOH , FILM- TABLET
LTD HYDROCHLOR PERAK , MALAYSIA COATED BLISTER
IDE TABLETS
5 NDA/MAL/H GITTOES GITTOES PROCIP CYPROHEPTA 2MG/5ML AGOG PHARMA LTD-PLOT INDIA ORAL LIQUID 1.0X100.0 7/1/2013
DP/0007 PHARMACEUT PHARMACEUTIC SYRUP DINE NO.33,SECTOR ORDINARY ML
ICALS LIMITED ALS LIMITED HYDROCHLOR II,VASAI,TALUKA INDL CO- SYRUPS BOTTLE
IDE OP ESTATE LTD,GAURAI
PADA,VASAI(E)DIST.THAN
E INDIA
6 NDA/MAL/H STALLION SHREEJI 02-LON OFLOXACIN + 200MG + ACME FORMULATION PVT INDIA ORAL SOLID 1.0X10.0X 7/1/2014
DP/0010 LABORATORIE PHARMACEUTIC ORNIDAZOLE 500MG LTD.-ROPAR ROAD, ORDINARY 10.0
S PVT LTD ALS LIMITED NALAGARH, DIST. SOLAN, FILM- TABLET
HIMACHAL PRADESH COATED BLISTER
174101 INDIA TABLETS
7 NDA/MAL/H INGELHEIM SURGIPHARM MICARDIS TELMISARTA 80MG BOEHRINGER INGELHEIM GERMANY ORAL SOLID 1.0X4.0X7 7/1/2015
DP/0011 PHARMACEUT (U) LIMITED 80 N PHARMA GMBH & CO. ORDINARY .0 TABLET
ICAL LTD KG.,-BIRKENDORFER TABLETS BLISTER
STRASSE 65, 88397,
8 NDA/MAL/H HOVID BHD UNITED PENGESIC TRAMADOL 100MG HOVID BHD-LOT 56442, MALAYSIA ORAL SOLID 1.0X3.0X1 7/1/2013
DP/0012 HEALTHCARE SR HYDROCHLOR 7.5 MILE JALAN RETARD 0.0
DISTRIBUTORS IDE SR IPOH/CHEMO 31200 TABLETS TABLET
LTD CHEMOR, PERAK BLISTER
MALAYSIA
9 NDA/MAL/H HOVID BHD UNITED MONTELAI MONTELUKAS 10MG HOVID BHD (IPOH SITE)- MALAYSIA ORAL SOLID 1.0X3.0X1 7/1/2014
DP/0014 HEALTHCARE R 10MG T 121 ,JALAN TUNKU ABDUL ORDINARY 0.0
DISTRIBUTORS TABLET RAHMAN , 30010 IPOH , FILM- TABLET
LTD PERAK , MALAYSIA COATED BLISTER
TABLETS
10 NDA/MAL/H REGAL REGAL PHARMA CODIMEX- CETIRIZINE 10MG REGAL KENYA ORAL SOLID 1.0X1.0X1 7/1/2014
DP/0016 PHARMACEUT (U) LTD CT TABLETS DIHYDROCHL PHARMACEUTICALS ORDINARY 0.0
ICALS LTD ORIDE LIMITED -PLOT 7879/18 FILM- TABLET
OF BABA DOGO ROAD, COATED BLISTER
RUARAKA, NAIROBI TABLETS
11 NDA/MAL/H SWISS SHREEJI HYCORT HYDROCORTI 100MG SWISS PARENTERALS LTD- INDIA PARENTERAL 1.0X10.0X 7/1/2011
DP/0017 PARENTERALS PHARMACEUTIC SONE 809 KERALA IND ESTATE ORDINARY 7.5 ML
LTD ALS LIMITED GIDC NEAR BAVLA DIST DRY VIALS VIAL
AHMEDABAD 382220
GUJARAT INDIA
12 NDA/MAL/H INGELHEIM SURGIPHARM CO- TELMISARTA 40MG + BOEHRINGER INGELHEIM GERMANY ORAL SOLID 1.0X4.0X7 7/1/1997
DP/0018 PHARMACEUT (U) LIMITED MICARDIS N+ 12.5MG PHARMA GMBH & CO. ORDINARY .0 TABLET
ICAL LTD HYDROCHLOR KG.,-BIRKENDORFER TABLETS BLISTER
OTHIAZIDE STRASSE 65, 88397,
13 NDA/MAL/H SAKAR ROYAL PHARMA QUINS QUININE 300MG/ML SAKAR HEALTHCARE PVT. INDIA PARENTERAL 1.0X100.0 7/1/2013
DP/0021 HEALTH CARE 2011 LIMITED DIHYDROCHL LTD-PLOT 10/13 SAKHEJ- ORDINARY X2.0 ML
PVT .LTD ORIDE BAVLA ROAD, AMPOULES AMPOULE
AHMEDABAD,GUJURAT,IN ,1.0X2.0X5
DIA .0X2.0 ML
AMPOULE
14 NDA/MAL/H GITTOES GITTOES QUININE QUININE 300MG AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1.0X10.0X 7/1/2009
DP/0022 PHARMACEUT PHARMACEUTIC SULPHATE SULPHATE NO.33,SECTOR ORDINARY 10.0
ICALS LIMITED ALS LIMITED II,VASAI,TALUKA INDL CO- TABLETS TABLET
OP ESTATE LTD,GAURAI BLISTER,1.
PADA,VASAI(E)DIST.THAN 0X1000.0
E INDIA TABLET
CONTAIN
ER
15 NDA/MAL/H KOPRAN TATA UGANDA AMPICLOXA AMPICILLIN + 250 MG + KOPRAN LIMITED-VILLAGE- INDIA ORAL SOLID 1.0X10.0X 7/1/1997
DP/0024 LIMITED LIMITED CLOXACILLIN 250 MG SAVROLI (KHOPOLI), ORDINARY 10.0
TALUKA- KHALAPUR, DIST. CAPSULES CAPSULE
RAIGAD, MAHARASHTRA, BLISTER
INDIA
16 NDA/MAL/H ASTRA LIFE ASTRA PHARMA AMLOAS-5 AMLODIPINE 5MG ASTRA LIFE CARE (INDIA) INDIA ORAL SOLID 1.0X10.0X 7/1/2013
DP/0025 CARE (INDIA) (U) LIMITED PVT.LTD-PLOT 57/P, ORDINARY 10.0
PVT LTD SARKHEJ-BAVLA TABLETS TABLET
HIGHWAY, RAJODA 382 BLISTER
220,TALUKA BAVLA DIST
AHMEDABAD, INDIA
17 NDA/MAL/H ASTRA LIFE ASTRA PHARMA AMLOAS-10 AMLODIPINE 10MG ASTRA LIFE CARE (INDIA) INDIA ORAL SOLID 1.0X10.0X 7/1/2015
DP/0026 CARE (INDIA) (U) LIMITED PVT.LTD-PLOT NO. 57/P, ORDINARY 10.0
HIGHWAY, POST RAJODA- BLISTER
382220, TALUKA BAVLA,
AHMEDABAD INDIA
18 NDA/MAL/H ASTRA LIFE ASTRA PHARMA HYPERLOK- ATENOLOL 50MG ASTRA LIFECARE (INDIA) INDIA ORAL SOLID 1.0X10.0X 7/1/2013
DP/0028 CARE (INDIA) (U) LIMITED 50 PVT. LTD-PLOT 57/P, ORDINARY 10.0
220, AHMEDABAD, INDIA
19 NDA/MAL/H ASTRA LIFE ASTRA PHARMA HYPERLOK- ATENOLOL 100MG ASTRA LIFECARE (INDIA) INDIA ORAL SOLID 1.0X10.0X 7/1/2013
DP/0029 CARE (INDIA) (U) LIMITED 100 PVT. LTD-PLOT 57/P, ORDINARY 10.0
20 NDA/MAL/H UNOSOURCE ABACUS TRADMIN TRAMADOL 50MG/ML AKUMS DRUGS & INDIA PARENTERAL 1.0X5.0X2 7/1/2015
DP/0030 PHARMA LTD PHARMA HYDROCHLOR PHARMACEUTICALS LTD. - ORDINARY .0 ML
(AFRICA) IDE PLANT III,-PLOT NO. 2, 3, 4 AMPOULES AMPOULE
LIMITED & 5, SECTOR 6-B, IIE,
SIDCUL,RANIPUR, 249 403
21 NDA/MAL/H MANKIND TATA UGANDA CEFTATIME- CEFTRIAXONE 1000MG+5 MANKIND PHARMA LTD-- INDIA PARENTERAL 1.0X1.5 G 7/1/2015
DP/0031 PHARM LTD LIMITED SB 1.5 +SULBACTAM 00MG VILLAGE KISHANPURA P.O ORDINARY VIAL
JAMNI WALA TEHSIL DRY VIALS
PAONTA SAHIB DISTT
SIRMOUR 173025
HIMACHAL PRADESH
22 NDA/MAL/H INGELHEIM SURGIPHARM CO- TELMISARTA 80MG + BOEHRINGER INGELHEIM GERMANY ORAL SOLID 1.0X4.0X7 7/1/2013
DP/0032 PHARMACEUT (U) LIMITED MICARDIS N+ 12.5MG PHARMA GMBH & CO. ORDINARY .0 TABLET
ICAL LTD HYDROCHLOR KG.,-BIRKENDORFER TABLETS BLISTER
OTHIZIDE STRASSE 65, 88397,
23 NDA/MAL/H ELYS VELVET ELYVATE BETAMETHAS 0.1%W/W ELYS CHEMICAL KENYA TOPICAL 1.0X15.0 7/1/1997
DP/0033 CHEMICAL PHARMA CREAM ONE INDUSTRIES LTD-ROAD 'B' EXTERNAL G TUBE
INDUSTRIES LIMITED VALERATE OFF ENTERPRISE ROAD, CREAMS
LTD INDUSTRIAL AREA
NAIROBI
24 NDA/MAL/H RENE RENE RECIM CIMETIDINE 200MG RENE INDUSTRIES LIMITED- UGANDA ORAL SOLID 1.0X10.0X 7/1/2013
DP/0041 INDUSTRIES INDUSTRIES PLOT 680, KAMULI ROAD, ORDINARY 10.0
LTD LIMITED KIREKA TABLETS TABLET
BLISTER
25 NDA/MAL/H KAMPALA KAMPALA KAMADOL PARACETAM 250MG KAMPALA UGANDA ORAL SOLID 1.0X10.0X 7/1/2013
DP/0043 PHARMACEUT PHARMACEUTIC JUNIOR OL PHARMACEUTICAL ORDINARY 10.0
ICAL AL INDUSTRIES INDUSTRIES (1996) TABLETS TABLET
INDUSTRIES 1996 LIMITED LIMITED - -STRETCHER BLISTER
(1996) LTD ROAD PLOT M444B
NTINDA KAMPALA
26 NDA/MAL/H GITTOES GITTOES AGOMOL PARACETAM 500MG AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1.0X1000. 7/1/2007
DP/0045 PHARMACEUT PHARMACEUTIC CAPLETS OL NO.33,SECTOR ORDINARY 0 TABLET
ICALS LIMITED ALS LIMITED II,VASAI,TALUKA INDL CO- TABLETS CONTAIN
OP ESTATE LTD,GAURAI ER,1.0X10
PADA,VASAI(E)DIST.THAN 0.0X10.0
E INDIA TABLET
BLISTER,1.
0X10.0X10
.0 TABLET
BLISTER
27 NDA/MAL/H MACLEODS NORVIK LAMIHOPE EFAVIRENZ + 600MG + MACLEODS INDIA ORAL SOLID 1.0X30.0 7/1/2015
DP/0047 PHARMACEUT ENTERPRISES ET LAMIVUDINE 300MG + PHARMACEUTICALS ORDINARY TABLET
ICALS LTD LIMITED + TENOFOVIR 300MG LIMITED (BLOCK –N1)- FILM- BOTTLE,1.
DISOPROXIL VILLAGE THEDA, P.O. COATED 0X90.0
FUMARATE LODHI MAJRA,TEHSIL TABLETS TABLET
BADDI, HIMACHAL CONTAIN
PRADESH -174101,INDIA ER,1.0X18
0.0
TABLET
CONTAIN
ER
28 NDA/MAL/H H. LUNDBECK PHILLIPS CLOPIXOL ZUCLOPENT 50MG/ML H. LUNDBECK A/S - DENMARK PARENTERAL 1.0X1.0 7/1/2015
DP/0051 A/S PHARMACEUTIC ACUPHASE HIXOL OTTILIAVEJ 9,2500 VALBY ORDINARY ML
ALS (UGANDA) ACETATE AMPOULES AMPOULE
LIMITED
29 NDA/MAL/H MEDICAL KARURI DISPERCAM PIROXICAM 0.5%W/V MEDICAL UNION EGYPT TOPICAL 1.0X15.0 7/1/2014
DP/0052 UNION PHARMACEUTIC PHARMACEUTICALS CO - EXTERNAL G
PHARMACEUT ALS LTD. 36 DR MOHAMED HASSAN GELS AND TUBE,1.0X
ICALS EL GAMAL ST. 6TH SOLS 30.0 G
DISTRICT NASR CITY, TUBE
CAIRO
30 NDA/MAL/H H. LUNDBECK PHILLIPS FLUANXOL FLUPENTIXOL 20MG/ML H. LUNDBECK A/S ,.,- DENMARK PARENTERAL 1.0X1.0 7/1/2015
DP/0053 A/S PHARMACEUTIC DEPOT DECANOATE OTTILIAVEJ 9, DK-2500, RETARD ML
ALS (UGANDA) VALBY-COPENHAGEN AMPOULES AMPOULE
LIMITED
31 NDA/MAL/H GOOD DAY PLANET FUNGOAL CLOTRIMAZO 1%W/W KREMOINT PHARMA PVT INDIA TOPICAL 1.0X20.0 7/1/2013
DP/0054 PHARMACY PHARMACEUTIC LE LTD---B-8 ADDITIONAL EXTERNAL G TUBE
LIMITED ALS UGANDA AMBERNATH MIDC OPP. CREAMS
LTD ANAND NAGAR POLICE
CHECK POST AMBERNATH
(E) DIST THANE 421 506
32 NDA/MAL/H H.LUNDBECK PHILLIPS CLOPIXOL ZUCLOPENT 200MG/ML H. LUNDBECK A/S ,.,- DENMARK PARENTERAL 1.0X1.0 7/1/2015
DP/0055 A/S PHARMACEUTIC DEPOT HIXOL OTTILIAVEJ 9, DK-2500, ORDINARY ML
ALS (UGANDA) DECANOATE VALBY-COPENHAGEN AMPOULES AMPOULE
LIMITED
33 NDA/MAL/H TROIKAA ABACUS DYNAPAR DICLOFENAC 4%W/V TROIKAA INDIA TOPICAL 1.0X30.0 7/1/2015
DP/0056 PHARMACEUT PHARMA QPS PHARMACEUTICALS LTD- EXTERNAL ML
ICALS LIMITED (AFRICA) THOL VILLAGE, DIST. SPRAYS BOTTLE,1.
LIMITED MEHSANA- 382728, WITHOUT 0X15.0 ML
GUJARAT, INDIA TROIKAA GAS BOTTLE
PHARMACEUTICALS LTD-
BLOCK NO. 2019, 2020,
2023, VILLAGE
VIROCHANNAGAR, TAL-
SANAND CITY:
AHMEDABAD, DIST.
AHMEDABAD-382170,
34 NDA/MAL/H NIRMA LIFE PHARMA WATER FOR WATER FOR N/A ACULIFE HEALTHCARE INDIA PARENTERAL 1.0X5.0 7/1/1997
DP/0058 LIMITED. AFRICA LIMITED INJECTION INJECTION PVT. LTD-VILLAGE ORDINARY ML
B.P. SACHANA ,TALUKA - AMPOULES AMPOULE
VIRAMGAM , ,1.0X10.0
AHMEDABAD 382150 ML
GUJARAT AMPOULE
35 NDA/MAL/H NABIQASIM JEET VAGIBACT CLINDAMYCI 2%W/W NABIQASIM INDUSTRIES PAKISTAN TOPICAL 1.0X40.0 7/1/2006
DP/0059 INDUSTRIES PHARMACEUTIC CREAM N (PVT) LTD√- EXTERNAL G TUBE +
(PVT) LTD. ALS LIMITED PHOSPHATE 17/24,KORANGI CREAMS 1
INDUSTRIAL AREA, APPLICAT
KORANGI, KARACHI- OR
PAKISTAN.
36 NDA/MAL/H MERCK (PTY) UNITED GONAL-F FOLLITROPIN 22 µG/0,5 MERCK SERONO SPA ITALY PARENTERAL 1.0X1.0 7/1/2015
DP/0060 LTD HEALTHCARE PEN 300 ALFA ML (BARI)-VIA DELLE SWITZERLAN ORDINARY CARTRIDG
DISTRIBUTORS IU/0,5 ML MAGNOLIE, 15 (LOC FRAZ D PRE-FILLED E
LTD (22 µG/0,5 ZONA INDUSTRIALE) PENS PREFILLED
ML) 70026, MODUGNO, BARI PEN + 8
NEEDLES
FOR
INJECTIO
N
37 NDA/MAL/H HETERO LABS AIVEEN (U) ABACAVIR ABACAVIR 600MG + HETERO LABS LTD. UNIT INDIA ORAL SOLID 1.0X30.0 7/1/2015
DP/0063 LTD LIMITED SULPHATE SULFATE + 300MG (V)-439, 440, 441& 458, ORDINARY TABLET
+ LAMIVUDINE APIIC, PHARMA SEZ, FILM- CONTAIN
LAMIVUDIN POLLEPALLY (VILLAGE), COATED ER
E JADCHERLA (MANDAL) TABLETS
MAHABOOB NAGAR (DIST)-
509301 INDIA.
38 NDA/MAL/H MERCK (PTY) UNITED GONAL-F FOLLITROPIN 33µG/ MERCK SERONO S.A. SWITZERLAN PARENTERAL 1.0X1.0 7/1/2015
DP/0064 LTD HEALTHCARE PEN 450 ALFA 0.7ML (MSA) -1170 SUCCURSALE D ORDINARY CARTRIDG
DISTRIBUTORS IU/ IE 0,75 D’AUBONNE ZONE CARTRIDGES E
LTD ML (33 µG) INDUSTRIELLE DE PREFILLED
L’OURIETTAZ, PEN + 12
SWITZERLAND NEEDLES
FOR
INJECTIO
N
39 NDA/MAL/H HOVID BHD UNITED ALENDRON ALENDRONAT 70MG HOVID BHD-LOT 56442 7 MALAYSIA ORAL SOLID 1.0X4.0 7/1/2015
DP/0065 HEALTHCARE ATE 70MG E SODIUM 1/2 MILES JALAN IPOH / ORDINARY TABLET
DISTRIBUTORS CHEMOR 31200 CHEMOR TABLETS BLISTER
LTD
40 NDA/MAL/H SAKAR ROYAL PHARMA ARTEES Α-Β 75MG/ML SAKAR HEALTHCARE PVT INDIA PARENTERAL 1.0X3.2 7/1/2013
DP/0067 HEALTH CARE 2011 LIMITED ARTEETHER LTD --406, SILVER OAKS ORDINARY ML
PVT .LTD COMMERCIAL COMPLEX, AMPOULES AMPOULE
41 NDA/MAL/H PFIZER LABOREX LIPITOR ATORVASTATI 10MG PFIZER LABORATORIES- GERMANY ORAL SOLID 1.0X28.0 7/1/1999
DP/0069 LABORATORIE UGANDA N GODECKE ORDINARY TABLET
S PTY LTD LIMITED MOOSWALDALLE 179090 TABLETS BLISTER
FR ,PFIZER
PHARMACEUTICALS LLC,
ROAD 689 KM 1.9 VEGA
BAJA, PUERTO RICO
42 NDA/MAL/H PFIZER LABOREX LIPITOR ATORVASTATI 20MG PFIZER LABORATORIES- GERMANY ORAL SOLID 1.0X28.0 7/1/1999
DP/0070 LABORATORIE UGANDA N GODECKE ORDINARY TABLET
S PTY LTD LIMITED MOOSWALDALLE 179090 TABLETS BLISTER,1.
FR ,PFIZER 0X3.0X10.
PHARMACEUTICALS LLC, 0 TABLET
ROAD 689 KM 1.9 VEGA BLISTER
BAJA, PUERTO RICO
43 NDA/MAL/H VHB MEDI LLOYDS AMTERICIN AMPHOTERIC 50MG VHB MEDI SCIENCES LTD- INDIA PARENTERAL 1.0X50.0 7/1/2013
DP/0072 SCIENCES LTD PHARMACY IN PLOT 20, 21, 22 & 49,50, ORDINARY MG VIAL
LIMITED 51. INTEGRATED VIALS
INDUSTRIAL AREA SECTOR
5, RUDRAPUR,
UTTARAKHAND - INDIA
44 NDA/MAL/H NAARI LTD ECHO FASILE-ONE LEVONORGES 1.5MG NAARI PHARMA PRIVATE INDIA ORAL SOLID 1.0X1.0 7/1/2013
DP/0073 PHARMACY (U) TREL TABLETS LIMITED-PLOT NO. 14-16, ORDINARY TABLET
LIMITED BP 55-57, SECTOR-5, IIE, TABLETS BLISTER
PANT NAGAR RUDRAPUR-
263153 DIST-U.S. NAGAR
UTTARAKHAND
45 NDA/MAL/H SUN STAR SYNRIAM ARTEROLANE 150 MG + SUN PHARMACEUTICALS INDIA ORAL SOLID 1.0X3.0 7/1/2014
DP/0075 PHARMACEUT PHARMACEUTIC MALEATE + 750 MG IND. LTD-B-2,MADAKAI ORDINARY TABLET
ICAL ALS LTD PIPERAQUINE INDUSTRIAL ESTATE, TABLETS BLISTER
INDUSTRIES PHOSPHATE PONDA,GOA-403404,
LIMITED INDIA
46 NDA/MAL/H ABACUS ABACUS X-SONE DEXAMETHAS 0.1 % W/V ABACUS PARENTERAL UGANDA OPHTHALMI 1.0X10.0 7/1/2015
DP/0077 PARENTERAL PARENTERAL ONE SODIUM DRUGS LTD.-PLOT NO. C DROPS ML VIAL
DRUGS DRUGS LIMITED PHOSPHATE 114, BLOCK 191,
LIMITED GWAGAMYA, KINGA,
KAPEKE,
MUKONO
47 NDA/MAL/H MYLAN KIMSY MEDS REVOKE 72 LEVONORGES 750MCG MYLAN LABORATORIES INDIA ORAL SOLID 1.0X2.0 7/1/2014
DP/0079 LABORATORIE LTD TREL LIMITED.--PLOT NO. 1606- ORDINARY TABLET
S LIMITED 1609, SARIGAM TABLETS BLISTER
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
48 NDA/MAL/H MYLAN KIMSY MEDS ZINNIA-F LEVONORGES 150MCG + MYLAN LABORATORIES INDIA ORAL SOLID 1.0X3.0X2 7/1/2014
DP/0083 LABORATORIE LTD TREL & 30MCG + LIMITED.--PLOT NO. 1606- ORDINARY 8.0
S LIMITED ETHINYLESTR 75MG 1609, SARIGAM TABLETS TABLET
ADIOL + INDUSTRIAL AREA, GIDC, BLISTER
FERROUS SARIGAM, TAL-UMERGAM,
FUMARATE DIST VALSAD, 396155,
PLOT NO.20 & 21,
PHARMEZ, SARKHEJ-
BAVLA NATIONAL
49 NDA/MAL/H GITTOES GITTOES D-LYTE CO- ANHYDROUS 2.7MG+0.5 AGOG PHARMA LTD-PLOT INDIA ORAL LIQUID 4.0X500.0 7/1/2015
DP/0088 PHARMACEUT PHARMACEUTIC PACK GLUCOSE+SO 2MG+0.58 NO.33,SECTOR ORDINARY ML
ICALS LIMITED ALS LIMITED DIUM MG+0.30M II,VASAI,TALUKA INDL CO- COMBINATI SACHET +
CHLORIDE+TR G+20MG OP ESTATE LTD,GAURAI ON PACK 1*10
ISODIUM PER PADA,VASAI(E)DIST.THAN POWDERS/G BLISTERS,
CITRATE+POT 200ML,6.7 E INDIA RANULES 10.0X200.
ASSIUM 5MG+1.30 0 ML
CHLORIDE/ZI MG+1.45M SACHET +
NC,ANHYDRO G+0.75MG 1*10
US +20MG BLISTERS,
GLUCOSE+SO PER 500ML 2.0X1000.
DIUM SACHET,13 0 ML
50 NDA/MAL/H ASTRA LIFE ASTRA PHARMA LORAS LORATADINE 10MG ASTRA LIFE CARE (INDIA) INDIA ORAL SOLID 1.0X3.0X1 7/1/2013
DP/0093 CARE (INDIA) (U) LIMITED PVT-SURVEY NO.57/P, ORDINARY 0.0
HIGHWAY, POST- RAJOD- BLISTER,1.
382220, TALUKA-BAVLA, 0X10.0X10
DIST-AHMEDABAD. .0 TABLET
BLISTER
51 NDA/MAL/H ASTRA LIFE ASTRA PHARMA LIPOR ATORVASTATI 20MG ASTRA LIFE CARE (INDIA) INDIA ORAL SOLID 1.0X2.0X1 7/1/2015
DP/0096 CARE (INDIA) (U) LIMITED N PVT-SURVEY NO.57/P, ORDINARY 5.0
PVT LTD SARKHEJ-BAVLA FILM- TABLET
HIGHWAY, POST- RAJOD- COATED BLISTER
382220, TALUKA-BAVLA, TABLETS
DIST-AHMEDABAD.
52 NDA/MAL/H MSN METRO SAFELEVO LEVOFLOXACI 750MG MSN LABORATORIES LTD- INDIA ORAL SOLID 1.0X3.0X1 7/1/2013
DP/0097 LABORATORIE PHARMACEUTIC 750 N PLOT 42 ANRICH ORDINARY 0.0
S LTD ALS LIMITED INDUSTRIAL ESTATE FILM- TABLET
BOLLARAM MEDAK COATED BLISTER,1.
DISTRICT 502325 ANDHRA TABLETS 0X1.0X10.
PRADESH 0 TABLET
BLISTER
53 NDA/MAL/H MSN METRO ATOREM 10 ATORVASTATI 10MG MSN LABORATORIES LTD- INDIA ORAL SOLID 1.0X3.0X1 7/1/2013
DP/0098 LABORATORIE PHARMACEUTIC N PLOT 42 ANRICH ORDINARY 0.0
S LTD ALS LIMITED INDUSTRIAL ESTATE FILM- TABLET
BOLLARAM MEDAK COATED BLISTER
DISTRICT 502325 ANDHRA TABLETS
PRADESH
54 NDA/MAL/H ASTRA LIFE ASTRA PHARMA CARBAS CARBAMAZEP 200MG ASTRA LIFE CARE (INDIA) INDIA ORAL SOLID 1.0X10.0X 7/1/2014
DP/0099 CARE (INDIA) (U) LIMITED INE PVT-SURVEY NO.57/P, ORDINARY 10.0
HIGHWAY, POST- RAJOD- BLISTER,1.
382220, TALUKA-BAVLA, 0X1000.0
DIST-AHMEDABAD. TABLET
CONTAIN
ER
55 NDA/MAL/H GITTOES GITTOES AGOTETRA TETRACYCLIN 250MG AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 10.0X10.0 7/1/1998
DP/0101 PHARMACEUT PHARMACEUTIC CAPSULES E NO.33,SECTOR ORDINARY CAPSULE
ICALS LIMITED ALS LIMITED HYDROCHLOR II,VASAI,TALUKA INDL CO- CAPSULES BLISTER,1.
IDE OP ESTATE LTD,GAURAI 0X500.0
PADA,VASAI(E)DIST.THAN CAPSULE
E INDIA CONTAIN
ER,1.0X10
00.0
CAPSULE
CONTAIN
ER,1.0X10
0.0
56 NDA/MAL/H MSN METRO SILMELT SILDENAFIL 100MG MSN LABORATORIES LTD- INDIA ORAL SOLID 1.0X2.0X2 7/1/2014
DP/0102 LABORATORIE PHARMACEUTIC 100 CITRATE PLOT 42 ANRICH ORDINARY .0 TABLET
S PRIVATE ALS LIMITED INDUSTRIAL ESTATE FILM- BLISTER
LIMITED BOLLARAM MEDAK COATED
PRADESH
57 NDA/MAL/H MSN METRO ATOREM 20 ATORVASTATI 20MG MSN LABORATORIES LTD- INDIA ORAL SOLID 1.0X3.0X1 7/1/2013
DP/0103 LABORATORIE PHARMACEUTIC N PLOT N0.42, ANRICH ORDINARY 0.0
S PRIVATE ALS LIMITED INDUSTRIAL ESTATE FILM- TABLET
LIMITED COATED BLISTER
TABLETS
58 NDA/MAL/H MSN METRO SILMELT 50 SILDENAFIL 50MG MSN LABORATORIES LTD- INDIA ORAL SOLID 1.0X2.0X2 7/1/2014
DP/0104 LABORATORIE PHARMACEUTIC CITRATE PLOT 42 ANRICH ORDINARY .0 TABLET
S PRIVATE ALS LIMITED INDUSTRIAL ESTATE TABLETS BLISTER
LIMITED BOLLARAM MEDAK
DISTRICT 502325 ANDHRA
PRADESH
59 NDA/MAL/H GITTOES GITTOES AGOSPRIN ACETYL 300MG AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 10.0X10.0 7/1/1998
DP/0105 PHARMACEUT PHARMACEUTIC TABLETS SALICYLIC NO.33,SECTOR ORDINARY TABLET
ICALS LIMITED ALS LIMITED ACID II,VASAI,TALUKA INDL CO- TABLETS BLISTER,1.
OP ESTATE LTD,GAURAI 0X500.0
PADA,VASAI(E)DIST.THAN TABLET
E INDIA CONTAIN
ER,1.0X10
0.0
TABLET
CONTAIN
ER,1.0X10
00.0
60 NDA/MAL/H MSN ABACUS SAFETELMI TELMISARTA 40MG MSN LABORATORIES LTD- INDIA ORAL SOLID 1.0X3.0X1 7/1/2013
DP/0110 LABORATORIE PHARMA 40 N PLOT 42 ANRICH ORDINARY 0.0
S PRIVATE (AFRICA) INDUSTRIAL ESTATE TABLETS TABLET
LIMITED LIMITED BOLLARAM MEDAK BLISTER
PRADESH
61 NDA/MAL/H MSN ABACUS SAFETELMI TELMISARTA 80MG MSN LABORATORIES LTD- INDIA ORAL SOLID 1.0X3.0X1 7/1/2013
DP/0111 LABORATORIE PHARMA 80 N PLOT 42 ANRICH ORDINARY 0.0
PRADESH
62 NDA/MAL/H NORVATIS SURGIPHARM EXFORGE AMLODIPINE 5 MG + NOVARTIS PHARMA STEIN SWITZERLAN ORAL SOLID 1.0X2.0X1 7/1/2007
DP/0112 PHARMA AG (U) LIMITED 5MG/160M + VALSARTAN 160 MG AG-H-4332 STEIN D ORDINARY 4.0
G SCHAFFAUSERTRASSE FILM- TABLET
NOVARTIS FARMACEUTICA COATED BLISTER
SA-RONDA DE SANTA TABLETS
MARIA,158, E-08210
BARBERA DEL VALLES
BARCELONA SPAIN
63 NDA/MAL/H MSN METRO BREATHEZY MONTELUKAS 4MG MSN LABORATORIES LTD - INDIA ORAL SOLID 1.0X3.0X1 7/1/2013
DP/0114 LABORATORIE PHARMACEUTIC 4 T SODIUM PLOT NO. 42 INDUSTRIAL ORDINARY 0.0
S PRIVATE ALS LIMITED ESTARE BOLLARAM CHEWABLE TABLET
LIMITED MEDAK DISTRIC 502325 TABLETS BLISTER
ANDHRA PRADESH
64 NDA/MAL/H MSN METRO BREATHEZY MONTELUKAS 5MG MSN LABORATORIES LTD- INDIA ORAL SOLID 1.0X3.0X1 7/1/2013
DP/0116 LABORATORIE PHARMACEUTIC CW 5 T SODIUM PLOT 42 ANRICH ORDINARY 0.0
S PRIVATE ALS LIMITED INDUSTRIAL ESTATE CHEWABLE TABLET
LIMITED BOLLARAM MEDAK TABLETS BLISTER
PRADESH
65 NDA/MAL/H ALKEM ABACUS ZOCEF 1.5G CEFUROXIME 1.5G ALKEM LABORATORIES INDIA PARENTERAL 1.0X1.0X1 7/1/2013
DP/0117 LABORATORIE PHARMA SODIUM LTD-VILLAGE – THANA, ORDINARY .5 G VIAL
S LIMITED (AFRICA) BADDI TEHSIL – DRY VIALS +1
LIMITED NALAGARH, DIST-SOLAN AMPOULE
(HP), INDIA – 173205 OF WFI
SANCE LABORATORIES
PVT LTD-VI/51B, P.B.
NO.2, KOZHUVANAL,
PALA, KOTTAYAM
DISTRICT-686573,
KERALA, INDIA.
66 NDA/MAL/H ALKEM ABACUS ZOCEF CEFUROXIME 750MG ALKEM LABORATORIES INDIA PARENTERAL 1.0X750.0 7/1/2013
DP/0118 LABORATORIE PHARMA 750MG SODIUM LTD-VILLAGE – THANA, ORDINARY MG VIAL
S LIMITED (AFRICA) BADDI TEHSIL – DRY VIALS +1
LIMITED NALAGARH, DIST-SOLAN AMPOULE
(HP), INDIA – 173205 WFI
SANCE LABORATORIES
NO.2, KOZHUVANAL,
PALA, KOTTAYAM
DISTRICT-686573,
KERALA, INDIA.
67 NDA/MAL/H DAWA SUPER MEDIC DACOLD CAFFEINE 30MG+4M DAWA LIMITED -BABA KENYA ORAL SOLID 1.0X10.0X 7/1/2013
DP/0119 LIMITED LTD ANHYDROUS+ G+400MG+ DOGO RWARAKA ORDINARY 10.0
CHLORPHENI 30MG CAPSULES CAPSULE
RAMINE BLISTER
MALEATE+PA
RACETAMOL+
PSEUDOEPHE
DRINE
68 NDA/MAL/H SHELYS BETA PEDZINC ZINC 20MG SHELYS PHAMACEUTICALS TANZANIA ORAL SOLID 1.0X10.0 7/1/2015
DP/0121 PHARMACEUT HEALTHCARE SULPHATE LTD .-NEW BAGAMOYO ORDINARY TABLET
ICALS LTD UGANDA RD, MWENGE, PLOT 696, TABLETS BLISTER
LIMITED DAR ES SALAAM BETA
HEALTH CARE
INTERNATIONAL LIMITED/-
PLOT NO. LR 209/ 6534
MOGADISHU ROAD,
KENYA
69 NDA/MAL/H DAWA SUPER MEDIC AMPECIN AMPICILLIN 125MG/5 DAWA LTD -PLOT KENYA ORAL LIQUID 1.0X100.0 7/1/2015
DP/0124 LIMITED LTD TRIHYDRATE ML NO.7879/8 BABA ROAD ORDINARY ML
RUARAKA NAIROBI DRY BOTTLE
SUSPENSION
S/SYRUPS/D
ROPS
70 NDA/MAL/H DAWA SUPER MEDIC SULPHUR SULPHUR 10%W/W DAWA LTD -PLOT KENYA TOPICAL 1.0X20.0 7/1/2013
DP/0125 LIMITED LTD OINTMENT NO.7879/8 BABA ROAD EXTERNAL G TUBE
RUARAKA NAIROBI OINTMENTS
71 NDA/MAL/H DAWA SUPER MEDIC WHITFIELD' BENZOIC 6.0%W/W DAWA LTD -PLOT KENYA TOPICAL 1.0X20.0 7/1/2014
DP/0126 LIMITED LTD S ACID + +3.0%W/W NO.7879/8 BABA ROAD EXTERNAL G TUBE
SALICYLIC RUARAKA NAIROBI OINTMENTS
ACID
72 NDA/MAL/H DELORBIS ABACUS CORYCARD IRBESARTAN 300MG + ZHEJIANG HUAHAI CHINA ORAL SOLID 1.0X3.0X1 7/1/2013
DP/0127 PHARMACEUT PHARMA ON + 12.5MG PHARMACEUTICAL CO. ORDINARY 0.0
ICALS LTD (AFRICA) HYDROCHLOR LTD-XUNQIAO, LINHAI, FILM- TABLET
LIMITED OTHIAZIDE ZHEJIANG PROVINCE COATED BLISTER
317024 PEOPLES’ TABLETS
REPUBLIC OF CHINA
73 NDA/MAL/H DELORBIS ABACUS CORYCARD IRBESARTAN 150MG + ZHEJIANG HUAHAI CHINA ORAL SOLID 1.0X3.0X1 7/1/2013
DP/0128 PHARMACEUT PHARMA ON + 12.5MG PHARMACEUTICAL CO. ORDINARY 0.0
ICALS LTD (AFRICA) HYDROCHLOR LTD-XUNQIAO, LINHAI, FILM- TABLET
LIMITED OTHIAZIDE ZHEJIANG PROVINCE COATED BLISTER
REPUBLIC OF CHINA
74 NDA/MAL/H ABBOT HARLEYS KLACID CLARITHROM 125MG/5 ABBOTT LABORATORIES SOUTH ORAL LIQUID 1.0X50.0 7/1/1998
DP/0131 LABORATORIE UGANDA P125 YCIN ML S.A (PTY) LTD-ABBOTT AFRICA ORDINARY ML
S S.A. (PTY) LIMITED PLACE,219 GOLF CLUB OTHER BOTTLE,1.
LTD TERRACE,CONSTANTIA POWDERS/G 0X100.0
KLOOF 1709 P.O BOX 7208 RANULES ML
WELTEVREDENPARK 1715 BOTTLE
75 NDA/MAL/H ABBOT HARLEYS KLACID CLARITHROM 500MG ABBOTT LABORATORIES SOUTH ORAL SOLID 1.0X10.0 7/1/1998
DP/0132 LABORATORIE UGANDA 500MG YCIN S.A (PTY) LTD-ABBOTT AFRICA ORDINARY TABLET
S S.A. (PTY) LIMITED PLACE,219 GOLF CLUB TABLETS BLISTER,1.
LTD TERRACE,CONSTANTIA 0X14.0
KLOOF 1709 P.O BOX 7208 TABLET
WELTEVREDENPARK 1715 BLISTER
76 NDA/MAL/H ABBOT HARLEYS KLACID CLARITHROM 250MG/5 ABBOTT LABORATORIES SOUTH ORAL LIQUID 1.0X50.0 7/1/1998
DP/0133 LABORATORIE UGANDA P250 YCIN ML S.A (PTY) LTD-ABBOTT AFRICA ORDINARY ML
S S.A. (PTY) LIMITED PLACE,219 GOLF CLUB OTHER BOTTLE,1.
LTD TERRACE,CONSTANTIA POWDERS/G 0X100.0
KLOOF 1709 P.O BOX 7208 RANULES ML
WELTEVREDENPARK 1715 BOTTLE
77 NDA/MAL/H SHELYS BETA HEMOVIT IRON + FOLIC 200MG + BETA HEALTHCARE TANZANIA ORAL LIQUID 1.0X200.0 7/1/2013
DP/0135 PHARMACEUT HEALTHCARE SYRUP ACID + 1.5MG + INTERNATIONAL LTD - ORDINARY ML
ICALS LTD UGANDA PYRIDOXINE + 0.5MG + PLOT NO LR 209/6534 SYRUPS BOTTLE
LIMITED CYANOCOBAL 50 MCG + MOGADISHU ROAD
AMIN + ZINC 2.33MG SHELYS PHAMACEUTICALS
LTD .-NEW BAGAMOYO
RD, MWENGE, PLOT 696,
DAR ES SALAAM
78 NDA/MAL/H ANGLIAN SUPER MEDIC MOXAFORT FLUCLOXACIL 250MG + DAWA PHARMACEUTICALS KENYA ORAL SOLID 1.0X2.0X1 7/1/2014
DP/0139 NUTRITION LTD E LIN SODIUM + 250MG LIMITED-PLOT 7879, BABA ORDINARY 0.0
PRODUCTS AMOXICILLIN DOGO ROAD RUARAKA CAPSULES CAPSULE
COMPANY TRIHYDRATE BLISTER
79 NDA/MAL/H COSMOS LTD ASTRA PHARMA NYCOSTAT NYSTATIN 100,000 COSMOS LIMITED-- KENYA ORAL LIQUID 1.0X30.0 7/1/1998
DP/0141 (U) LIMITED SUSPENSIO I.U/ML RANGWA ROAD, OFF ORDINARY ML
N LUNGA LUNGA ROAD,P.O SUSPENSION BOTTLE
BOX 414 33, NAIORBI S
INDUSTRIAL AREA
80 NDA/MAL/H PFIZER LAB LABOREX PREVENAR PNEUMOCOC 2.2MCG OF WYETH UNITED PARENTERAL 1.0X0.5 7/1/2011
DP/0142 LTD UGANDA 13 CAL POLYSACC PHARMACEUTICALS INC- STATES ORDINARY ML VIAL
LIMITED POLYSACCHA HARIDE 401 N MIDDLETOWN RD VIALS (1 DOSE)
RIDE FOR PEARL RIVER NY 10965
CONJUGATE SEROTYPES
VACCINE (13- 1,3,4,5,6A,
VALENT.ADSO 7F.9V,14,1
RBED) 8C,19A,19F
,23F,AND
4.4MCG
FOR
SEROTYPE
81 NDA/MAL/H MYLAN KIMSY MEDS NEXQUIN LEVOFLOXACI 500MG MSN LABORATORIES LTD- INDIA ORAL SOLID 1.0X10.0 7/1/2013
DP/0144 PHARMACEUT LTD 500 N PLOT 42 ANRICH ORDINARY TABLET
ICAL PRIVATE INDUSTRIAL ESTATE FILM- BLISTER
LIMITED, BOLLARAM MEDAK COATED
INDIA DISTRICT 502325 ANDHRA TABLETS
PRADESH
82 NDA/MAL/H MYLAN KIMSY MEDS TELKAST 10 MONTELUKAS 10MG MSN LABORATORIES LTD - INDIA ORAL SOLID 1.0X3.0X1 7/1/2013
DP/0145 PHARMACEUT LTD T SODIUM PLOT NO. 42 INDUSTRIAL ORDINARY 0.0
ICAL PRIVATE ESTARE BOLLARAM TABLETS TABLET
LIMITED, MEDAK DISTRIC 502325 BLISTER
INDIA ANDHRA PRADESH
83 NDA/MAL/H MYLAN KIMSY MEDS SYNCLAV AMOXICILLIN 875 MG + MEDREICH LIMITED UNIT INDIA ORAL SOLID 1.0X2.0X7 7/1/2013
DP/0148 PHARMACEUT LTD 1000 + 125 MG 1-12TH MILE, OLD ORDINARY .0 TABLET
ICAL PRIVATE CLAVULANAT MADRAS ROAD, FILM- BLISTER
LIMITED, E POTASSIUM VIRGONAGAR, COATED
INDIA BANGOLORE-560049 TABLETS
MEDOPHARM PVT LTD -
NO. 50 KAYARAMBEDU
VILLAGE GUDUVANCHERY-
603203 TAMIL NADU
84 NDA/MAL/H MYLAN KIMSY MEDS SYNCLAV AMOXICILLIN 500 MG + MEDREICH LIMITED –UNIT INDIA ORAL SOLID 1.0X2.0X7 7/1/2013
DP/0149 PHARMACEUT LTD 625 + POTASSIUM 125 MG I-12TH MILE, OLD MADRAS ORDINARY .0 TABLET
ICAL PRIVATE CLAVULANAT ROAD, VIRGONAGAR FILM- BLISTER
LIMITED, E COATED
INDIA BANGALORE-560 049, TABLETS
INDIA
MEDOPHARM PVT LTD -
NO. 50 KAYARAMBEDU
VILLAGE GUDUVANCHERY-
603203 TAMIL NADU
85 NDA/MAL/H MYLAN KIMSY MEDS SYNCLAV AMOXYCILLIN 200 MG + MEDREICH LIMITED –UNIT INDIA ORAL LIQUID 1.0X70.0 7/1/2013
DP/0150 PHARMACEUT LTD 228 + 28.5 MG I-12TH MILE, OLD MADRAS ORDINARY ML
ICAL PRIVATE CLAVULANAT ROAD, VIRGONAGAR DRY BOTTLE
LIMITED, E POTASSIUM SUSPENSION
INDIA BANGALORE-560 049, S/SYRUPS/D
INDIA ROPS
86 NDA/MAL/H MYLAN KIMSY MEDS CARDITEL TELMISARTA 80MG MSN LABORATORIES LTD- INDIA ORAL SOLID 1.0X3.0X1 7/1/2013
DP/0151 PHARMACEUT LTD 80 N PLOT 42 ANRICH ORDINARY 0.0
ICAL PRIVATE INDUSTRIAL ESTATE TABLETS TABLET
LIMITED, BOLLARAM MEDAK BLISTER
INDIA DISTRICT 502325 ANDHRA
PRADESH
87 NDA/MAL/H DELORBIS ABACUS RYCARDON IRBESARTAN 150MG ZHEJIANG HUAHAI CHINA ORAL SOLID 1.0X3.0X1 7/1/2013
DP/0152 PHARMACEUT PHARMA 150 PHARMACEUTICAL CO. ORDINARY 0.0
ICALS LTD (AFRICA) LTD-XUNQIAO, LINHAI, FILM- TABLET
LIMITED ZHEJIANG PROVINCE COATED BLISTER
REPUBLIC OF CHINA
DELORBIS
17 ATHINON STR.,
ERGATES INDUSTRIAL
AREA, 2643 ERGATES, P.O.
BOX 28629, 2081
88 NDA/MAL/H DELORBIS ABACUS RYCARDON IRBESARTAN 300MG ZHEJIANG HUAHAI CHINA ORAL SOLID 1.0X3.0X1 7/1/2013
DP/0153 PHARMACEUT PHARMA 300 PHARMACEUTICAL CO. ORDINARY 0.0
ICALS LTD (AFRICA) LTD-XUNQIAO, LINHAI, FILM- TABLET
LIMITED ZHEJIANG PROVINCE COATED BLISTER
REPUBLIC OF CHINA
DELORBIS
17 ATHINON STR.,
ERGATES INDUSTRIAL
BOX 28629, 2081
89 NDA/MAL/H TORRENT KARURI ASTHATOR MONTELUKAS 10MG TORRENT INDIA ORAL SOLID 1.0X3.0X1 7/1/2013
DP/0155 PHARMACEUT PHARMACEUTIC 10 T SODIUM PHARMACEUTICALS LTD .,- ORDINARY 0.0
ICALS LIMITED ALS LTD. AHMEDABAD-MEHSANA TABLETS TABLET
HIGHWAY, TALUKA-KADI, BLISTER
DIST. MEHSANA, INDRAD-
382721, GUJARAT
90 NDA/MAL/H RENE RENE RECODIN CODEINE 10MG + RENE INDUSTRIES LIMITED- UGANDA ORAL LIQUID 1.0X100.0 7/1/2015
DP/0157 INDUSTRIES INDUSTRIES PHOSPHATE + 4MG /5ML PLOT 680, KAMULI ROAD, ORDINARY ML
LTD LIMITED CHLORPHENI KIREKA SYRUPS BOTTLE
RAMINE
MALEATE
91 NDA/MAL/H MEGA ABACUS KIPEL 10 MONTELUKAS 10MG MSN LABORATORIES LTD- INDIA ORAL SOLID 1.0X3.0X1 7/1/2015
DP/0158 LIFESCIENCES PHARMA T SODIUM PLOT 42 ANRICH ORDINARY 0.0
(AUSTRALIA) (AFRICA) INDUSTRIAL ESTATE FILM- TABLET
PTY LTD LIMITED BOLLARAM MEDAK COATED BLISTER
PRADESH
92 NDA/MAL/H UNICHEM EUROPA TIZIGESIC TIZANIDINE 2MG UNICHEM LABORATORIES INDIA ORAL SOLID 1.0X3.0X1 7/1/2016
DP/0160 LABORATORIE HEALTHCARE HYDROCHLOR LIMITED-C–31,32 & D-10, ORDINARY 0.0
S LTD (U) LTD IDE INDUSTRIAL AREA, TABLETS TABLET
MEERUT ROAD, BLISTER
GHAZIABAD, U.P.
93 NDA/MAL/H RENE RENE COSYP-D DEXTROMET 10MG RENE INDUSTRIES LIMITED- UGANDA ORAL LIQUID 1.0X100.0 7/1/2015
DP/0162 INDUSTRIES INDUSTRIES LINCTUS HORPHAN +4MG PLOT 680, KAMULI ROAD, ORDINARY ML
LTD LIMITED HYDROBROM /5ML KIREKA SYRUPS BOTTLE
IDE +
CHLORPHENA
MINE
MALEATE
94 NDA/MAL/H RENE RENE PHENAREN PROMETHAZI 5MG/5ML RENE INDUSTRIES LIMITED- UGANDA ORAL LIQUID 1.0X60.0 7/1/2015
DP/0163 INDUSTRIES INDUSTRIES NE PLOT 680, KAMULI ROAD, ORDINARY ML
LIMITED LIMITED HYDROCHLOR KIREKA SYRUPS BOTTLE
IDE
95 NDA/MAL/H RENE RENE RENPRESS PROPRANOLO 40MG RENE INDUSTRIES LIMITED- UGANDA ORAL SOLID 1.0X10.0X 7/1/2014
DP/0164 INDUSTRIES INDUSTRIES L PLOT 680, KAMULI ROAD, ORDINARY 10.0
LIMITED LIMITED KIREKA TABLETS TABLET
BLISTER
96 NDA/MAL/H TORRENT KARURI TOLANZ 5 OLANZAPINE 5MG TORRENT INDIA ORAL SOLID 1.0X3.0X1 7/1/2013
DP/0165 PHARMACEUT PHARMACEUTIC ORODISPERSI PHARMACEUTICALS LTD .,- ORDINARY 0.0
ICALS LIMITED ALS LTD. BLE TABLETS AHMEDABAD-MEHSANA ORALLY TABLET
HIGHWAY, TALUKA-KADI, DISINTEGRA BLISTER
DIST. MEHSANA, INDRAD- TING
382721, GUJARAT TABLETS
97 NDA/MAL/H RENE RENE X-PEL MEBENDAZOL 100MG/5 RENE INDUSTRIES LIMITED- UGANDA ORAL LIQUID 1.0X30.0 7/1/2015
DP/0166 INDUSTRIES INDUSTRIES E ML PLOT 680, KAMULI ROAD, ORDINARY ML
LTD LIMITED KIREKA SUSPENSION BOTTLE
S
98 NDA/MAL/H TORRENT KARURI TOLANZ 10 OLANZAPINE 10MG TORRENT INDIA ORAL SOLID 1.0X3.0X1 7/1/2013
DP/0167 PHARMACEUT PHARMACEUTIC ORODISPERSI PHARMACEUTICALS LTD .,- ORDINARY 0.0
ICALS LIMITED ALS LTD. BLE TABLETS AHMEDABAD-MEHSANA ORALLY TABLET
HIGHWAY, TALUKA-KADI, DISINTEGRA BLISTER
DIST. MEHSANA, INDRAD- TING
382721, GUJARAT TABLETS
99 NDA/MAL/H MSN METRO FEBUDAY FEBUXOSTAT 80MG MSN LABORATORIES LTD- INDIA ORAL SOLID 1.0X3.0X1 7/1/2014
DP/0168 LABORATORIE PHARMACEUTIC PLOT 42 ANRICH ORDINARY 0.0
S PRIVATE ALS LIMITED INDUSTRIAL ESTATE TABLETS TABLET
LIMITED BOLLARAM MEDAK BLISTER
PRADESH
100 NDA/MAL/H ASTRA LIFE ASTRA PHARMA ROSUVAX ROSUVASTATI 10MG ASTRA LIFE CARE (INDIA) INDIA ORAL SOLID 1.0X2.0X1 7/1/2015
DP/0169 CARE (INDIA) (U) LIMITED 10 N PVT-SURVEY NO.57/P, ORDINARY 5.0
HIGHWAY, POST- RAJOD- COATED BLISTER
382220, TALUKA-BAVLA, TABLETS
DIST-AHMEDABAD.
101 NDA/MAL/H BAYER SURGIPHARM XARELTO RIVAROXABA 10MG BAYER HEALTHCARE AG,-D- GERMANY ORAL SOLID 1.0X1.0X1 7/1/2013
DP/0175 SCHERING (U) LIMITED 10MG N 51368, LEVERKUSEN ORDINARY 0.0
PHARMA FILM- TABLET
COATED BLISTER
TABLETS
102 NDA/MAL/H REGAL REGAL PHARMA COLDCAP DAY DAY TIME REGAL KENYA ORAL SOLID 1.0X3.0X8 7/1/2013
DP/0178 PHARMACEUT (U) LTD DAYTIME TIME(PARACE (500MG + PHARMACEUTICALS ORDINARY .0
ICALS LTD AND NIGHT TAMOL 30MG + LIMITED -PLOT 7879/18 CAPSULES CAPSULE
TIME +CAFFEINE 30MG) OF BABA DOGO ROAD, BLISTER
CAPSULE ANHYDROUS+ AND RUARAKA, NAIROBI
PSEUDOEPHE NIGHT
DRINE HCL) TIME
AND NIGHT (500MG
TIME(PARACE +2MG)
TAMOL
+CHLORPHEN
IRAMINE
103 NDA/MAL/H MSN METRO FEBUDAY FEBUXOSTAT 40MG MSN LABORATORIES LTD- INDIA ORAL SOLID 1.0X3.0X1 7/1/2014
DP/0182 LABORATORIE PHARMACEUTIC 40 PLOT 42 ANRICH ORDINARY 0.0
S PRIVATE ALS LIMITED INDUSTRIAL ESTATE FILM- TABLET
LIMITED BOLLARAM MEDAK COATED BLISTER
PRADESH
104 NDA/MAL/H WIDE WIDE BBC SPRAY BENZOCAINE 1.5%W/V+ AMOUN EGYPT ORAL 1.0X25.0 7/1/2014
DP/0186 SPECTRUM SPECTRUM +BENZYDAMI 0.15%W/V PHARMACEUTICALS CO. TOPICAL ML
ENTERPRISES ENTERPRISES NE+CATALKO +0.0413% S.A.E-1ST INDUSTRIAL SPRAYS BOTTLE
(U) LIMITED (U) LIMITED NIUM W/V ZONE, EL-OBOUR CITY, WITHOUT
CHLORIDE EGYPT. GAS
105 NDA/MAL/H AMOUN WIDE KAPRON TRANEXAMIC 500 MG AMOUN EGYPT ORAL SOLID 1.0X2.0X1 7/1/2014
DP/0187 PHARMACEUT SPECTRUM TABLET ACID PHARMACEUTICALS CO. ORDINARY 0.0
ICAL ENTERPRISES S.A.E-1ST INDUSTRIAL TABLETS TABLET
COMPANY (U) LIMITED ZONE, EL-OBOUR CITY, BLISTER
EGYPT.
106 NDA/MAL/H AMOUN BOOTS LEVOXIN LEVOFLOXACI 500MG AMOUN EGYPT ORAL SOLID 1.0X5.0 7/1/2014
DP/0188 PHARMACEUT PHARMACEUTIC N PHARMACEUTICALS CO. ORDINARY TABLET
ICALS LTD ALS LIMITED S.A.E-1ST INDUSTRIAL FILM- BLISTER
ZONE, EL-OBOUR CITY, COATED
EGYPT. TABLETS
107 NDA/MAL/H CIPLA LTD QUALITY NEVIMUNE NEVIRAPINE 200MG CIPLA LTD--PLOT NO L- INDIA ORAL SOLID 1.0X6.0X1 7/1/2001
DP/0189 CHEMICALS LTD - TABLETS 139,VERNA IND ESTATE, ORDINARY 0.0
HUMAN VERNA GOA-403 INDIA TABLETS TABLET
BLISTER,1.
0X60.0
TABLET
CONTAIN
ER
108 NDA/MAL/H MEDOPHARM PLANET CLEDOMOX AMOXICILLIN 200 MG + MEDOPHARM PVT LTD.- INDIA ORAL LIQUID 1.0X70.0 7/1/2013
DP/0191 PRIVATE PHARMACEUTIC 228.5 + 28.5 MG NO. 50 KAYARAMBEDU ORDINARY ML
LIMITED ALS UGANDA CLAVULANAT VILLAGE GUDUVANCHERY DRY BOTTLE
LTD E 603 203 CHENGALPET SUSPENSION
DISTRICT TAMIL NADU S/SYRUPS/D
ROPS
109 NDA/MAL/H MEDOPHARM PLANET CLEDOMOX AMOXICILLIN 500 MG + MEDOPHARM PVT LTD.- INDIA ORAL SOLID 1.0X2.0X7 7/1/2013
DP/0193 PRIVATE PHARMACEUTIC 625 + 125 MG NO. 50 KAYARAMBEDU ORDINARY .0 TABLET
LIMITED ALS UGANDA CLAVULANIC VILLAGE GUDUVANCHERY FILM- BLISTER
LTD ACID 603 203 CHENGALPET COATED
DISTRICT TAMIL NADU TABLETS
110 NDA/MAL/H CIPLA CIPLA QUALITY LAMIVUDIN LAMIVUDINE/ 150MG/30 CIPLA QUALITY CHEMICAL UGANDA ORAL SOLID 1.0X60.0 7/1/2013
DP/0196 QUALITY CHEMICAL E AND ZIDOVUDINE 0MG INDUSTRIES LIMITED - - ORDINARY TABLET
CHEMICAL INDUSTRIES ZIDOVUDIN PLOT 1-7 1ST RING ROAD, OTHER CONTAIN
INDUSTRIES LIMITED E TABLETS LUZIRA, KAMPALA COATED ER
LIMITED TABLETS
111 NDA/MAL/H CIPLA LTD QUALITY EFAVIR-600 EFAVIRENZ 600MG CIPLA QUALITY CHEMICAL INDIA ORAL SOLID 1.0X30.0 7/1/2004
DP/0197 CHEMICALS LTD - INDUSTRIES LIMITED - - ORDINARY TABLET
HUMAN PLOT 1-7 1ST RING ROAD, TABLETS CONTAIN
LUZIRA, KAMPALA CIPLA ER
LTD -PLOT NO. L-139,
VERNA, GOA 403 722
INDIA
112 NDA/MAL/H CIPLA CIPLA QUALITY NEVIRAPIN NEVIRAPINE 200MG CIPLA QUALITY CHEMICAL UGANDA ORAL SOLID 1.0X60.0 7/1/2013
DP/0198 LIMITED CHEMICAL E TABLETS INDUSTRIES LIMITED - - ORDINARY TABLET
INDUSTRIES 200 MG PLOT 1-7 1ST RING ROAD, TABLETS BOTTLE
LIMITED LUZIRA, KAMPALA
113 NDA/MAL/H GLAXOSMITH UNITED SERETIDE SALMETEROL 25MCG + GLAXO WELLCOME- FRANCE LUNG 1.0X120.0 7/1/2015
DP/0203 LINE LTD HEALTHCARE EVOHALER XINAFOATE + 250MCG PRODUCTION ZONE ADMINISTRA METERED
DISTRIBUTORS 250 FLUTICASONE INDUSTRIELLE NO. 2 23, TION CFC- DOSE
LTD PROPIONATE RUE LAVOISIER 27000 FREE CANNISTE
EVREUX METERED- R
DOSE
INHALER
114 NDA/MAL/H GLAXOSMITH UNITED TIVICAY DOLUTEGRAV 50MG GLAXO OPERATIONS UK UNITED ORAL SOLID 1.0X30.0 7/1/2015
DP/0204 KLINE HEALTHCARE IR SODIUM LTD-WARE SG120DJ KINGDOM ORDINARY TABLET
PHARMACEUT DISTRIBUTORS UNITED KINGDOM TABLETS CONTAIN
ICAL KENYA LTD ER
LTD
115 NDA/MAL/H MACLEODS NORVIK LAMIVUDIN LAMIVUDINE 300MG MACLEODS INDIA ORAL SOLID 1.0X30.0 7/10/2013
DP/0207 PHARMACEUT ENTERPRISES E AND + TENOFOVIR +300MG PHARMACEUTICALS LTD--- ORDINARY TABLET
ICAL LTD LIMITED TENOFOVIR DISOPROXIL PLOT NO 25-27 SURVEY FILM- BOTTLE
DISOPROXIL FUMARATE PREMEIRE INDUSTRIAL COATED
FUMARATE ESTATE KACHIGAM TABLETS
DAMAN (U.T) 396401
MACLEODS
PHARMACEUTICALS
LIMITED (BLOCK –N1)-
VILLAGE THEDA, P.O.
LODHI MAJRA,TEHSIL
BADDI, HIMACHAL
116 NDA/MAL/H HETERO LABS AIVEEN (U) ABACAVIR ABACAVIR 20MG/ML HETERO LABS PRIVATE INDIA ORAL LIQUID 1.0X240.0 7/1/2013
DP/0209 LTD LIMITED SULPHATE SULPHATE LIMITED UNIT III-SURVEY ORDINARY ML
ORAL NO. 51, PLOT 22-110, LIQUIDS BOTTLE
SOLUTION INDUSTRIAL
DEVELOPMENT AREA
(I.D.A) JEEDIMETLA,
HYDERABAD-500 055,
TELANGANA STATE
117 NDA/MAL/H MEDICAL KARURI HEPATICU SILYMARIN 140MG MEDICAL UNION EGYPT ORAL SOLID 1.0X3.0X1 7/1/2011
DP/0210 UNION PHARMACEUTIC M PHARMACEUTICALS-36 DR ORDINARY 0.0
PHARMACEUT ALS LTD. MOHAMED HASSAN EL- CAPSULES CAPSULE
ICALS GAMAL ST.6TH DISTRICT BLISTER
NASR CITY EGYPT
118 NDA/MAL/H MEDICAL KARURI HEPATICU SILYMARIN 1G/100ML MEDICAL UNION EGYPT ORAL LIQUID 1.0X120.0 7/1/2012
DP/0212 UNION PHARMACEUTIC M PHARMACEUTICALS-36 DR ORDINARY ML
PHARMACEUT ALS LTD. MOHAMED HASSAN EL- SUSPENSION BOTTLE
ICALS GAMAL ST.6TH DISTRICT S
NASR CITY EGYPT
119 NDA/MAL/H AUROBINDO PHILLIPS AUROPODO CEFPODOXIM 200MG AUROBINDO PHARMA LTD INDIA ORAL SOLID 1.0X10.0 7/1/2013
DP/0213 PHARMA LTD PHARMACEUTIC X 200 E (UNIT VI) ,.,.,-SURVEY ORDINARY TABLET
(UNIT VI) ALS (UGANDA) NOS. 329/39 & 329/47, FILM- BLISTER
LIMITED CHITKUL VILLAGE, COATED
PATANCHERU MANDAL, TABLETS
MEDAK DISTRICT PIN
CODE 502307, ANDHRA
PRADESH
120 NDA/MAL/H ABACUS ABACUS PALETHER ARTEMETHER 80MG/ML LINCOLN PARENTERAL LTD INDIA PARENTERAL 2.0X3.0X1 7/1/2014
DP/0217 PARENTERAL PARENTERAL .-11, TRIMUL ESTATE, ORDINARY I .0 ML
DRUGS DRUGS LIMITED NEAR KHATRAJ CHOKADI, M AMPOULE
LIMITED P.O. BOX KHATRAJ 382721 AMPOULES
TA: KALOL DIST.
GANDHINAGAR GUJARAT
121 NDA/MAL/H DAWA SUPER MEDIC AMPICLO- AMPICILLIN + 250 MG + DAWA PHARMACEUTICALS KENYA ORAL SOLID 1.0X10.0X 7/1/2013
DP/0221 LIMITED LTD DAWA CLOXACILLIN 250 MG LIMITED-PLOT 7879, BABA ORDINARY 10.0
DOGO ROAD RUARAKA CAPSULES CAPSULE
BLISTER
122 NDA/MAL/H ABACUS ABACUS AVIR-200 ACYCLOVIR 500MG LINCOLN INDIA ORAL SOLID 1.0X10.0X 7/1/2013
DP/0222 PARENTERAL PARENTERAL PHARMACEUTICALS LTD .- ORDINARY 10.0
DRUGS DRUGS LIMITED 10,12,13 TRIMUL ESTATE, TABLETS TABLET
LIMITED NEAR KHATRAJ CHOKADI, BLISTER
P.O. KHATRAJ-382721 TA:
KALOL, DIST.
GANDHINAGAR, GUJARAT
123 NDA/MAL/H ABACUS ABACUS TOPCID-150 RANITIDINE 150MG LINCOLN INDIA ORAL SOLID 1.0X10.0X 7/1/2013
DP/0223 PHARMA LTD PARENTERAL PHARMACEUTICALS LTD .- ORDINARY 10.0
DRUGS LIMITED 10,12,13 TRIMUL ESTATE, TABLETS TABLET
NEAR KHATRAJ CHOKADI, STRIP
KALOL, DIST.
124 NDA/MAL/H ABACUS ABACUS DIKON DICLOFENAC/ 1%W/W+1 LINCOLN INDIA TOPICAL 1.0X15.0 7/1/2013
DP/0225 PARENTERAL PARENTERAL PLUS SALICYLATE/ 0%W/W+5 PHARMACEUTICALS LTD .- EXTERNAL G
DRUGS DRUGS LIMITED MENTHOL/LI %W/W+3% 10,12,13 TRIMUL ESTATE, GELS AND CONTAIN
LIMITED NSEED W/W NEAR KHATRAJ CHOKADI, SOLS ER
KALOL, DIST.
125 NDA/MAL/H KOPRAN TATA UGANDA TRIM-960 TRIMETHOPRI 160MG/80 KOPRAN LTD-VILLAGE INDIA ORAL SOLID 1.0X1000. 7/1/2014
DP/0228 LIMITED LIMITED M/SULFAMET 0MG SAVROLI TAL KHARAPUR ORDINARY 0 TABLET
HOXAZOLE DIST RAIGAD 410 202 TABLETS CONTAIN
ER,1.0X10
.0X10.0
TABLET
BLISTER
126 NDA/MAL/H STRIDES DELMAW COMBIART ARTHEMETHE 20MG STRIDES SHASUN LIMITED- INDIA ORAL SOLID 1.0X4.0X6 7/1/2013
DP/0230 SHASUN ENTERPRISES R + +120MG NO. 36/7, ORDINARY .0 TABLET
LIMITED LIMITED LUMEFANTRI SURAGAJAKKANAHALLI, TABLETS BLISTER,1.
NE INDLAVADI CROSS, 0X1.0X6.0
ANEKAL TALUK, TABLET
BENGALURU, KARNATAKA, BLISTER,1.
562106 0X1.0X12.
0 TABLET
BLISTER,1.
0X1.0X18.
0 TABLET
BLISTER,1.
127 NDA/MAL/H TORRENT KARURI BRANTA LOSARTAN 50MG + TORRENT INDIA ORAL SOLID 1.0X3.0X1 7/1/2013
DP/0232 PHARAMACE PHARMACEUTIC POTASSIUM + 5MG PHARMACEUTICALS LTD .,- ORDINARY 0.0
UTICALS LTD ALS LTD. AMLODIPINE AHMEDABAD-MEHSANA TABLETS TABLET
BESILATE HIGHWAY, TALUKA-KADI, BLISTER
382721, GUJARAT
128 NDA/MAL/H INDOCO STAR CLOB CLOTRIMAZO 1%W/W INDOCO REMEDIES INDIA TOPICAL 1.0X20.0 7/1/2004
DP/0236 REMEDIES PHARMACEUTIC LE LIMITED-L-14 VERNA EXTERNAL G
LIMITED ALS LTD INDUSTRIAL AREA VERNA CREAMS TUBE,1.0X
15.0 G
TUBE
129 NDA/MAL/H MYLAN KIMSY MEDS KOMEFAN ARTEMETHER 40 MG + MYLAN LABORATORIES INDIA ORAL SOLID 1.0X12.0 7/1/2041
DP/0237 LABORATORIE LTD 280 + 240 MG LTD--F-4,F-12 MALEGAON ORDINARY TABLET
S LIMITED LUMEFANTRI MIDC SINNAR NASHIK TABLETS BLISTER
NE 422113 MAHARASHTRA
STATE
130 NDA/MAL/H MYLAN KIMSY MEDS KOMEFAN ARTEMETHER 20 MG+ MYLAN LABORATORIES INDIA ORAL SOLID 1.0X6.0X3 7/1/2014
DP/0239 LABORATORIE LTD 140 + 120 MG LTD--F-4,F-12 MALEGAON ORDINARY .0 TABLET
S LIMITED LUMEFANTRI MIDC SINNAR NASHIK TABLETS BLISTER,1.
NE 422113 MAHARASHTRA 0X18.0
STATE TABLET
BLISTER,1.
0X24.0
TABLET
BLISTER
131 NDA/MAL/H CADILA ABACUS EUGLIM 4 GLIMEPIRIDE 4MG CADILA HEALTHCARE INDIA ORAL SOLID 1.0X10.0X 7/1/2014
DP/0245 HEALTHCARE PHARMA LIMITED -KUNDAIM ORDINARY 10.0
LTD (AFRICA) INDUSTRIAL ESTATE,PLOT TABLETS TABLET
LIMITED NO.203-213, KUNDAIM BLISTER
GOA, 403115,
132 NDA/MAL/H IPCA MEDVIN PANTONEX PANTOPRAZO 40 MG IPCA LABORATORIES LTD- INDIA ORAL SOLID 1.0X3.0X1 7/1/2013
DP/0248 LABORATORIE PHARMA DR-40 LE PLOT NO. 255/1, ORDINARY 0.0
S LTD LIMITED VILLAGE ATHAL, ENTERIC- TABLET
SILVASSA-396230, COATED BLISTER
DADRA AND NAGAR TABLETS
HAVELI, INDIA.
133 NDA/MAL/H ABACUS ABACUS DIKON DICLOFENAC 1%W/W LINCOLN INDIA TOPICAL 1.0X20.0 7/1/2013
DP/0250 PARENTERAL PARENTERAL PHARMACEUTICALS LTD .- EXTERNAL G
DRUGS DRUGS LIMITED 10,12,13 TRIMUL ESTATE, GELS AND CONTAIN
LIMITED NEAR KHATRAJ CHOKADI, SOLS ER
KALOL, DIST.
134 NDA/MAL/H LINCOLN METRO VAST-40 ATORVASTATI 40MG LINCOLN INDIA ORAL SOLID 1.0X3.0X1 7/1/2014
DP/0252 PHARMACEUT PHARMACEUTIC N PHARMACEUTICALS LTD .- ORDINARY 0.0
ICALS LTD ALS LIMITED 10,12,13 TRIMUL ESTATE, TABLETS TABLET
NEAR KHATRAJ CHOKADI, BLISTER
KALOL, DIST.
135 NDA/MAL/H ABACUS ABACUS TENLOW-5 AMLODIPINE 5MG LINCO N INDIA ORAL SOLID 1.0X3.0X1 7/1/2013
DP/0253 PARENTERAL PHARMA BESYLATE PHARMACEUTICALS ORDINARY 0.0
DRUGS (AFRICA) LIMITED-TRIMUL ESTATE TABLETS TABLET
LIMITED LIMITED KHATRAJ KALOL GUJARAT BLISTER
INDIA
136 NDA/MAL/H MERCK (PTY) UNITED CONCOR 5 BISOPROLOL 5MG MERCK KGAA-250 GERMANY ORAL SOLID 1.0X3.0X1 7/1/2013
DP/0254 LTD HEALTHCARE HEMIFUMAR FRANKFRUTER STRASSE ORDINARY 0.0
DISTRIBUTORS ATE 250-64293 DARMSTADT FILM- TABLET
LTD WINTHROP COATED BLISTER
PHARMACEUTICALS(PTY) TABLETS
LTD,-315 WATLOO
ROAD,WATLOO,PRETORIA,
SOUTHAFRICA (FPP
SECONDARY
PACKAGING,FPP
RELEASE/QC TESTING
SITE)
137 NDA/MAL/H HETERO LABS AIVEEN (U) CAPETERO CAPECITABIN 500MG HETERO LABS (UNIT VI), INDIA ORAL SOLID 1.0X120.0 7/1/2015
DP/0256 LTD LIMITED 500 E INDIA-APIIC, ORDINARY TABLET
FORMULATION SEZ, FILM- CONTAIN
POLEPALLY COATED ER
(V),JEDCHERLA(M) TABLETS
MAHABOOBNAGER
DISTRICT ANDHRA
PRADESH-509301, INDIA.
138 NDA/MAL/H SANOFI SURGIPHARM CORDARON AMIODARON 200MG SANOFI WINTHROP FRANCE ORAL SOLID 1.0X3.0X1 7/1/1998
DP/0257 AVENTS (U) LIMITED E E INDUSTRIE-LAGRAGE ORDINARY 0.0
FRANCE HYDROCHLOR 33565 CARBON BLANC TABLETS TABLET
IDE CEDEX FRANCE BLISTER,1.
0X2.0X15.
0 TABLET
BLISTER
139 NDA/MAL/H ASTRA ASTRA PHARMA BENZATHIN BENZATHINE 2.400.000 CSPC ZHONGNUO CHINA PARENTERAL 1.0X50.0 7/1/2001
DP/0266 PHARMA (UK) (U) LIMITED E PENICILLIN IU PHARMACEUTICAL ORDINARY VIAL
LTD PENICILLIN (SHIJIAZHUANG)CO. LTD- DRY VIALS CARTON
INJECTION NO. 88, YANGZI ROAD,
SHIJIAZHUANG CITY,
HEBEI
PROVINCE(WORKSHOP
406 AND 407)
140 NDA/MAL/H LINCOLN METRO VOMISTAT- ONDANSETR 8MG LINCOLN INDIA ORAL SOLID 1.0X10.0X 7/1/2014
DP/0269 PHARMACEUT PHARMACEUTIC 8 ON PHARMACEUTICALS ORDINARY 10.0
ICALS LTD ALS LIMITED LIMITED -10, 12, 13, FILM- TABLET
TRIMUL ESTATE, AFTER COATED BLISTER
VADSCAR VILLAGE, NEAR TABLETS
KHATRAJ CHOKADI,
KHATRAJ-382721,
GHANDHINAGAR,
GUJARAT, INDIA
141 NDA/MAL/H HETERO LABS AIVEEN (U) LEVIN LEVOFLOXACI 500MG HETERO LABS LTD (UNIT- INDIA ORAL SOLID 1.0X10.0X 7/1/2001
DP/0270 LTD LIMITED 500MG N V)-SY.NO.438,439,440 & ORDINARY 10.0
HEMIHYDRAT 458 APIIC FORMULATION FILM- TABLET
E SEZ, POLEPALLY (V), COATED BLISTER,1.
JEDCHERLA (M) TABLETS 0X10.0
MAHABOOBNAGAR TABLET
DISTRICT, ANDHRA BLISTER
PRADESH - INDIA
142 NDA/MAL/H BIOLOGICAL GITTOES BETT TETANUS 40 I.U BIOLOGICAL E LTD-PLOT INDIA PARENTERAL 1.0X20.0X 7/1/2001
DP/0271 E. LTD PHARMACEUTIC VACCNE NO.1, S.P ORDINARY 10.0 ML
ALS LIMITED ADSORBED BIOTECHNOLOGY PARK, AMPOULES AMPOULE
PHASE II KOLTHER (V), ,1.0X24.0X
SHAMEERPET(M), RANGA 10.0 ML
REDDY(DIST), ANDHRA AMPOULE
PRADESH, INDIA 500078 ,1.0X5.0
ML VIAL
(10
DOSES)
143 NDA/MAL/H HETERO LABS AIVEEN (U) LEVIN 250 LEVOFLOXACI 250MG HETERO LABS LTD. UNIT INDIA ORAL SOLID 1.0X10.0X 7/1/2019
DP/0272 LTD LIMITED N (V)-439, 440, 441& 458, ORDINARY 10.0
APIIC, PHARMA SEZ, FILM- TABLET
POLLEPALLY (VILLAGE), COATED BLISTER
JADCHERLA (MANDAL) TABLETS
509301 INDIA.
144 NDA/MAL/H GLAXO UNITED ZENTEL ALBENDAZOL 400MG GLAXOSMITHKLINE SOUTH SOUTH ORAL SOLID 1.0X1.0 7/1/2011
DP/0275 SMITHLINE HEALTHCARE E AFRICA (PTY) LTD-39 AFRICA ORDINARY TABLET
LIMITED DISTRIBUTORS HAWKINS AVENUE, CHEWABLE BLISTER
LTD EPPING INDUSTRIAL, CAPE TABLETS
TOWN, 7460, SOUTH
AFRICA
145 NDA/MAL/H MICRO LABS LABOREX MELANOV GLICLAZIDE 80MG MICRO LABS LTD--NO 92, INDIA ORAL SOLID 1.0X3.0X1 7/1/2013
DP/0276 LTD UGANDA 80 SIPCOT, HOSUR-635 126,, ORDINARY 0.0
LIMITED TAMIL NADU, INDIA TABLETS TABLET
BLISTER
146 NDA/MAL/H COSMOS LTD ASTRA PHARMA CHLORPRO CHLORPROM 100MG COSMOS LTD.-RANGWE KENYA ORAL SOLID 1.0X1000. 7/1/1998
DP/0278 (U) LIMITED MAZINE AZINE ROAD; OFF LUNGA LUNGA ORDINARY 0 TABLET
TABLETS HYDROCHLOR ROAD. P.O BOX 414 33, TABLETS CONTAIN
B.P 100MG IDE NAIROBI ER,1.0X10
0.0
TABLET
CONTAIN
ER,10.0X1
0.0
TABLET
BLISTER
147 NDA/MAL/H DAWA SUPER MEDIC AMPICLO- AMPICILLIN + 125 MG + DAWA PHARMACEUTICALS KENYA ORAL LIQUID 1.0X100.0 7/1/2013
DP/0283 LIMITED LTD DAWA CLOXACILLIN 125 MG LIMITED-PLOT 7879, BABA ORDINARY ML
DOGO ROAD RUARAKA DRY BOTTLE
SUSPENSION
S/SYRUPS/D
ROPS
148 NDA/MAL/H GLAXO UNITED CLAVULIN AMOXICILLIN 1000 MG + SMITHKLINE BEECHAM UNITED PARENTERAL 10.0X1.2 7/1/2009
DP/0284 SMITHLINE HEALTHCARE + 200 MG PHARMACEUTICALS,- KINGDOM ORDINARY G VIAL
LIMITED DISTRIBUTORS CLAVULANIC CLARENDON ROAD, DRY VIALS
LTD ACID WORTHING, WEST
SUSSEX, BN148QH
149 NDA/MAL/H GUILIN STAR GLUMAC ARTEMETHER 20MG+120 GUILIN PHARMACEUTICAL CHINA ORAL SOLID 1.0X24.0 7/1/2014
DP/0286 PHARMACEUT PHARMACEUTIC +LUMEFANTR MG CO. LTD-NO. 17 SHANGHAI ORDINARY TABLET
ICAL CO.LTD ALS LTD INE ROAD, GUILIN 541002, TABLETS BLISTER,1.
GUANXI CHINA 0X6.0
TABLET
BLISTER,1.
0X18.0
TABLET
BLISTER,1.
0X12.0
TABLET
BLISTER
150 NDA/MAL/H GOOD DAY PLANET POWER METHYL 15%W/W KREMOINT PHARMA PVT INDIA TOPICAL 1.0X25.0 7/1/2013
DP/0287 PHARMACY PHARMACEUTIC HEAT SALICYLATE LTD---B-8 ADDITIONAL EXTERNAL G
LIMITED ALS UGANDA AMBERNATH MIDC OPP. CREAMS TUBE,1.0X
LTD ANAND NAGAR POLICE 30.0 G
CHECK POST AMBERNATH TUBE
151 NDA/MAL/H UNIVERSAL HARLEYS DUXCOSPA HYOSCINE 10MG UNIVERSAL CORPORATION KENYA ORAL SOLID 1.0X10.0X 7/1/2013
DP/0288 CORPORATIO UGANDA N BUTYL LIMITED -PLOT 13777 ORDINARY 10.0
N LTD LIMITED BROMIDE KIKUYU ROAD, KIKUYU TABLETS TABLET
TOWN, PAST POST OFFICE BLISTER
152 NDA/MAL/H LABORATORY HARLEYS NATOA MEBENDAZOL 100MG LABORATORY & ALLIED KENYA ORAL SOLID 1.0X1.0X6 7/1/1997
DP/0290 & ALLIED LTD UGANDA E LTD--PLOT NO. 209/ ORDINARY .0 TABLET
LIMITED 10349, OPP. SAMEER CHEWABLE BLISTER,1.
BUSINESS PARK, TABLETS 0X1000.0
MOMBASA ROAD P.O. TABLET
BOX 42875, GPO 00100, CONTAIN
NAIROBI, KENYA ER,1.0X10
.0X10.0
TABLET
BLISTER
153 NDA/MAL/H HETERO LABS AIVEEN (U) DARUNAVI DARUNAVIR 600 MG HETERO LABS LTD-22-110 INDIA ORAL SOLID 1.0X60.0 7/1/2014
DP/0293 LTD LIMITED R IDA JEEDIMETLA ORDINARY TABLET
HYDERABAD 500-055 TABLETS BOTTLE
ANDHRA PRADESH
154 NDA/MAL/H COSMOS LTD ASTRA PHARMA PRAZITEL PRAZIQUANT 600MG COSMOS LIMITED-- KENYA ORAL SOLID 2.0X10.0 7/1/1998
DP/0296 (U) LIMITED TABLETS EL RANGWA ROAD, OFF ORDINARY TABLET
LUNGA LUNGA ROAD,P.O FILM- BLISTER,1.
BOX 414 33, NAIORBI COATED 0X10.0X10
INDUSTRIAL AREA TABLETS .0 TABLET
BLISTER
155 NDA/MAL/H SAKAR ROYAL PHARMA SEFIXI-50 CEFIXIME 50MG SAKAR HEALTH CARE PVT, INDIA ORAL LIQUID 1.0X1.0X6 7/1/2013
DP/0298 HEALTH CARE 2011 LIMITED DRY SYRUP LTD-BLOCK NO. 10-13,M.N ORDINARY 0.0 ML
PVT .LTD DESAI PETROL DRY BOTTLE
PUMP,SARKHEJ-BAVLA SUSPENSION
ROAD,VILLAGE S/SYRUPS/D
CHANGODAR DIST ROPS
AHMEDABAD 382-
213,GUJARAT-INDIA
156 NDA/MAL/H HETERO LABS AIVEEN (U) MONAST 10 MONTELUKAS 10MG HETERO LABS LTD. UNIT INDIA ORAL SOLID 1.0X3.0X1 7/1/2013
DP/0301 LTD LIMITED T SODIUM (V)-S.N0.439, 440, 441& ORDINARY 0.0
458, APIIC, PHARMA SEZ, TABLETS TABLET
POLLEPALLY (VILLAGE), BLISTER
JADCHERLA (MANDAL)
509301 INDIA
157 NDA/MAL/H HETERO LABS AIVEEN (U) ABACAVIR ABACAVIR 300MG HETERO DRUGS LTD, UNIT INDIA ORAL SOLID 1.0X60.0 7/1/2014
DP/0303 LTD LIMITED SULPHATE SULPHATE III -22-110, IDA, ORDINARY TABLET
JEEDIMETLA FILM- CONTAIN
COATED ER
TABLETS
158 NDA/MAL/H HETERO LABS AIVEEN (U) DARUNAVI DARUNAVIR 400MG HETERO LABS LTD-22-110 INDIA ORAL SOLID 1.0X60.0 7/1/2014
DP/0304 LTD LIMITED R IDA JEEDIMETLA ORDINARY TABLET
HYDERABAD 500-055 TABLETS CONTAIN
ANDHRA PRADESH ER
159 NDA/MAL/H SAKAR ROYAL PHARMA CEFAX-250 CEFALEXIN 250MG/5 SAKAR HEALTH CARE PVT, INDIA ORAL LIQUID 1.0X1.0X5 7/1/2013
DP/0305 HEALTH CARE 2011 LIMITED DRY SYRUP ML LTD-BLOCK NO. 10-13,M.N ORDINARY 0.0 ML
PVT .LTD DESAI PETROL SOLUBLE BOTTLE,1.
PUMP,SARKHEJ-BAVLA POWDERS 0X1.0X100
ROAD,VILLAGE .0 ML
CHANGODAR DIST BOTTLE
AHMEDABAD 382-
213,GUJARAT-INDIA
160 NDA/MAL/H HETERO AIVEEN (U) LAMIVUDIN LAMIVUDINE 10MG/ML HETERO DRUGS LTD, UNIT INDIA ORAL LIQUID 1.0X240.0 7/1/2013
DP/0307 DRUGS LTD LIMITED E ORAL III -22-110, IDA, ORDINARY ML
SOLUTION JEEDIMETLA SOLUBLE CONTAIN
POWDERS ER
161 NDA/MAL/H SAKAR ROYAL PHARMA CEFAX-250 CEFALEXIN 250MG SAKAR HEALTH CARE PVT, INDIA ORAL SOLID 1.0X10.0X 7/1/2013
DP/0308 HEALTH CARE 2011 LIMITED LTD-BLOCK NO. 10-13,M.N ORDINARY 10.0
PVT .LTD DESAI PETROL CAPSULES CAPSULE
PUMP,SARKHEJ-BAVLA BLISTER
ROAD,VILLAGE
CHANGODAR DIST
AHMEDABAD 382-
213,GUJARAT-INDIA
162 NDA/MAL/H MARTINDALE LABOREX FENTANYL FENTANYL 50MCG/ML MARTINDALE UNITED PARENTERAL 1.0X10.0X 7/1/2013
DP/0311 PHARMACEUT UGANDA CITRATE PHARMACEUTICAL KINGDOM ORDINARY 2.0 ML
ICALS LTD LIMITED LIMITED -BAMPTON ROAD AMPOULES AMPOULE
RMM38UG ENGLAND
163 NDA/MAL/H SPARSH BIO- ABACUS CLOXISPA CLOXACILLIN 125MG/5 SPARSH BIO-TECH LTD- INDIA ORAL LIQUID 1.0X100.0 7/1/2013
DP/0312 TECH PVT LTD PHARMA ORAL ML PLOT NO.1 SURVEY ORDINARY ML
(AFRICA) SOLUTION NO.242/234/244, VILLAGE DRY BOTTLE
LIMITED 125 LAKHABARAD, JAMNAGAR- SUSPENSION
361006 S/SYRUPS/D
ROPS
164 NDA/MAL/H MARTINDALE LABOREX SUXAMETH SUXAMETHO 50MG/ML MARTINDALE PHARMA - UNITED PARENTERAL 1.0X10.0X 7/1/2013
DP/0314 PHARMACEUT UGANDA ONIUM NIUM BAMPTON ROAD, HAROLD KINGDOM ORDINARY 2.0 ML
ICALS LTD LIMITED CHLORIDE CHLORIDE HILL,ROMFORD,RM3844 AMPOULES AMPOULE
SOLUTION
FOR
INJECTION
165 NDA/MAL/H DAWA SUPER MEDIC SABULIN SALBUTAMOL 4MG DAWA LTD -PLOT KENYA ORAL SOLID 1.0X10.0X 7/1/2013
DP/0318 LIMITED LTD NO.7879/8 BABA ROAD ORDINARY 10.0
RUARAKA NAIROBI TABLETS TABLET
BLISTER
166 NDA/MAL/H DAWA SUPER MEDIC DAZOLE CLOTRIMAZO 1%W/W DAWA LTD -PLOT KENYA TOPICAL 1.0X20.0 7/1/2013
DP/0320 LIMITED LTD LE NO.7879/8 BABA ROAD EXTERNAL G TUBE
RUARAKA NAIROBI CREAMS
167 NDA/MAL/H MICRO LABS PHILLIPS NEBILONG- NEBIVOLOL 5MG MICRO LABS LTD-92, INDIA ORAL SOLID 1.0X3.0X1 7/1/2009
DP/0322 LTD PHARMACEUTIC 5 HCL SIPCOT INDUSTRIAL ORDINARY 0.0
ALS (UGANDA) COMPLEX HOSU R-635126 TABLETS TABLET
LIMITED (T.N) INDIA BLISTER
168 NDA/MAL/H ARISTO NORVIK OSTEBON CALCIUM + 250MG + ARISTO INDIA ORAL LIQUID 1.0X200.0 7/1/2014
DP/0326 PHARMACEUT ENTERPRISES COLECALCIFE 125 IU PHARMACEUTICALS PVT ORDINARY ML
ICALS PVT LTD LIMITED ROL LIMITED-PLOT 208, NEW SUSPENSION BOTTLE
INDUSTRIAL AREA NO II, S
MANDIDEEP-462 046
(DISTRICT) RAISEN,
MADHYA PRADESH INDIA
169 NDA/MAL/H ASTRA LIFE ASTRA PHARMA ROSUVAX ROSUVASTATI 20MG ASTRA LIFE CARE (INDIA) INDIA ORAL SOLID 1.0X2.0X1 7/1/2015
DP/0332 CARE (INDIA) (U) LIMITED 20 N CALCIUM PVT.LTD-PLOT NO. 57/P, ORDINARY 5.0
HIGHWAY, POST RAJODA- COATED BLISTER
382220, TALUKA BAVLA, TABLETS
AHMEDABAD INDIA
170 NDA/MAL/H KOPRAN TATA UGANDA CLAVAMYN- AMOXICILLIN 500MG KOPRAN LIMITED-VILLAGE- INDIA ORAL SOLID 1.0X2.0X1 7/1/2014
DP/0333 LIMITED LIMITED 625 TRIHYDRATE +125MG SAVROLI (KHOPOLI), ORDINARY 0.0
+ POTASSIUM TALUKA- KHALAPUR, DIST. TABLETS TABLET
CLAVULANAT RAIGAD, MAHARASHTRA, BLISTER
E INDIA
171 NDA/MAL/H GOOD DAY PLANET NEOMYCIN NEOMYCIN 0.5%WW KREMOINT PHARMA PVT INDIA TOPICAL 1.0X1.0X3 7/1/2013
DP/0335 PHARMACY PHARMACEUTIC SULPHATE SULPHATE LTD-B-8,ADDITIONAL EXTERNAL 0.0 G
LIMITED ALS UGANDA CREAM USP CREAM USP AMBERNATH MIDC, CREAMS TUBE
LTD AMBERNATH (E),DIST:
THANE 421506, INDIA
172 NDA/MAL/H ASTRA LIFE ASTRA PHARMA AS-DP DICYCLOMINE 20MG+500 ASTRA LIFECARE (INDIA) INDIA ORAL SOLID 1.0X10.0X 7/1/2013
DP/0336 CARE (INDIA) (U) LIMITED TABLETS HCL + MG PVT. LTD-PLOT 57/P, ORDINARY 10.0
PVT LTD PARACETAM SARKHEJ-BAVLA TABLETS TABLET
OL HIGHWAY, RAJODA 382 STRIP
173 NDA/MAL/H IND-SWIFT PLANET SWAZI *500 AZITHROMYCI 500MG IND SWIFT LTD-GLOBAL INDIA ORAL SOLID 1.0X3.0 7/1/2014
DP/0337 PHARMACEUTIC N BUSINESS UNIT ORDINARY TABLET
ALS UGANDA JAWAHARPUR OFF NH-21 FILM- BLISTER
LTD DERABASSI DIST MOHALI COATED
PUNJAB 140507 TABLETS
174 NDA/MAL/H KOPRAN TATA UGANDA KORAB 20 RABEPRAZOL 20MG KOPRAN LIMITED-VILLAGE- INDIA ORAL SOLID 1.0X1.0X1 7/1/2013
DP/0338 LIMITED LIMITED E SODIUM SAVROLI (KHOPOLI), ORDINARY 0.0
TALUKA- KHALAPUR, DIST. TABLETS TABLET
RAIGAD, MAHARASHTRA, BLISTER
INDIA
175 NDA/MAL/H IND-SWIFT PLANET SWAZI *250 AZITHROMYCI 250MG IND SWIFT LTD-GLOBAL INDIA ORAL SOLID 1.0X6.0 7/1/2014
DP/0339 PHARMACEUTIC N BUSINESS UNIT ORDINARY TABLET
ALS UGANDA JAWAHARPUR OFF NH-21 FILM- BLISTER
LTD DERABASSI DIST MOHALI COATED
PUNJAB 140507 TABLETS
176 NDA/MAL/H GOOD DAY PLANET SONADAY CLOBETASOL- 0.05%W/W KREMOINT PHARMA PVT INDIA TOPICAL 1.0X15.0 7/1/2013
DP/0340 PHARMACY PHARMACEUTIC 17-BUTYRATE +0.1%W/W LTD---B-8 ADDITIONAL EXTERNAL G TUBE
LIMITED ALS UGANDA + +2%W/W AMBERNATH MIDC OPP. CREAMS
LTD GENTAMYCIN ANAND NAGAR POLICE
SULPHATE + CHECK POST AMBERNATH
MICONAZOLE (E) DIST THANE 421 506
NITRATE
177 NDA/MAL/H IND SWIFT PLANET TELSWIFT- TELMISARTA 40MG + IND SWIFT LTD-GLOBAL INDIA ORAL SOLID 1.0X4.0X1 7/1/2014
DP/0341 LTD PHARMACEUTIC H 40 N+ 12.5MG BUSINESS UNIT ORDINARY 0.0
ALS UGANDA HYDROCHLOR JAWAHARPUR OFF NH-21 TABLETS TABLET
LTD OTHIAZIDE DERABASSI DIST MOHALI BLISTER
PUNJAB 140507
178 NDA/MAL/H IND SWIFT PLANET TELSWIFT- TELMISARTA 80MG + IND SWIFT LTD-GLOBAL INDIA ORAL SOLID 1.0X4.0X7 7/1/2014
DP/0342 LTD PHARMACEUTIC H 80 N+ 12.5MG BUSINESS UNIT ORDINARY .0 TABLET
ALS UGANDA HYDROCHLOR JAWAHARPUR OFF NH-21 TABLETS BLISTER
LTD OTHIAZIDE DERABASSI DIST MOHALI
PUNJAB 140507
179 NDA/MAL/H GOOD DAY PLANET WHITFIELD' BENZOIC 6% W/W + KREMOINT PHARMA PVT INDIA TOPICAL 1.0X25.0 7/1/2013
DP/0343 PHARMACY PHARMACEUTIC S ACID + 3% W/W LTD---B-8 ADDITIONAL EXTERNAL G TUBE
LIMITED ALS UGANDA OINTMENT SALICYLIC AMBERNATH MIDC OPP. OINTMENTS
LTD B.P ACID ANAND NAGAR POLICE
180 NDA/MAL/H ABACUS ABACUS XBETA BETAMETHAS 0.1%W/V ABACUS PARENTERAL UGANDA OPHTHALMI 1.0X10.0 7/1/2015
DP/0348 PARENTERAL PARENTERAL ONE SODIUM DRUGS LIMITED-BLOCK C DROPS ML VIAL
DRUGS DRUGS LIMITED PHOSPHATE 191, PLOT NO. 114,
LIMITED GWAWANYA KINGA AND
KAPEKA MUKONO
DISTRICT, UGANDA.
181 NDA/MAL/H RENE RENE CETRIREN CETIRIZINE 10MG RENE INDUSTRIES LIMITED- UGANDA ORAL SOLID 1.0X10.0X 7/1/2015
DP/0350 INDUSTRIES INDUSTRIES HYDROCHLOR PLOT 680, KAMULI ROAD, ORDINARY 10.0
LTD LIMITED IDE KIREKA TABLETS TABLET
BLISTER
182 NDA/MAL/H MANKIND TATA UGANDA DEPREGDIN LEVONORGES 1.5MG ACME FORMULATION PVT INDIA ORAL SOLID 1.0X1.0 7/1/2014
DP/0351 PHARM LTD LIMITED A TREL LTD.-ROPAR ROAD, ORDINARY TABLET
NALAGARH, DIST. SOLAN, TABLETS BLISTER
HIMACHAL PRADESH
174101 INDIA
183 NDA/MAL/H HOVID BHD UNITED DEROX-10 AMLODIPINE 10MG HOVID BHD -121 ,JALAN MALAYSIA ORAL SOLID 1.0X3.0X1 7/1/2015
DP/0353 HEALTHCARE BESILATE TUNKU ABDUL RAHMAN , ORDINARY 0.0
DISTRIBUTORS 30010 IPOH , PERAK , TABLETS TABLET
LTD MALAYSIA BLISTER,1.
0X3.0X1.0
X10.0
TABLET
BLISTER
184 NDA/MAL/H KOPRAN TATA UGANDA LEVOKOP LEVOFLOXACI 500MG KOPRAN LIMITED-VILLAGE- INDIA ORAL SOLID 1.0X10.0 7/1/2013
DP/0354 LIMITED LIMITED N SAVROLI (KHOPOLI), ORDINARY TABLET
TALUKA- KHALAPUR, DIST. FILM- BLISTER
RAIGAD, MAHARASHTRA, COATED
INDIA TABLETS
185 NDA/MAL/H SWISS SHREEJI BICO VITA THIAMINE 10MG + SWISS PARENTERALS LTD- INDIA PARENTERAL 1.0X10.0X 7/1/2015
DP/0355 PARENTERALS PHARMACEUTIC HCL + 0.1MG + 809 KERALA IND ESTATE ORDINARY 2.0 ML
LTD ALS LIMITED RIBOFLAVIN + 1MG + GIDC NEAR BAVLA DIST AMPOULES AMPOULE
PYRIDOXINE 10MG AHMEDABAD 382220
HCL + GUJARAT INDIA
NICOTINAMI
DE
186 NDA/MAL/H DENK BENLE CONSULT LEVO DENK LEVOFLOXACI 500MG ROTTENDORF PHARMA GERMANY ORAL SOLID 1.0X5.0 7/1/2014
DP/0356 PHARMA LIMITED 50O N GMBH-OSTENFELDER ORDINARY TABLET
GMBH & CO HEMIHYDRAT STRASSE 51-61 59320 FILM- BLISTER,1.
KG E ENNIGERLOH GERMANY COATED 0X1.0X10.
TABLETS 0 TABLET
BLISTER
187 NDA/MAL/H SWISS SHREEJI STREPTOCI STREPTOMYC 1GM SWISS PARENTERALS LTD- INDIA PARENTERAL 1.0X1.0 G 7/1/2014
DP/0358 PARENTERALS PHARMACEUTIC N IN SULPHATE 809 KERALA IND ESTATE ORDINARY I VIAL
LTD ALS LIMITED GIDC NEAR BAVLA DIST M VIALS
AHMEDABAD 382220
GUJARAT INDIA
188 NDA/MAL/H ASTRA MACNAUGHTON NEXIUM ESOMEPRAZO 20MG ASTRA ZENECA AB, SWEDEN ORAL SOLID 1.0X4.0X7 7/1/2001
DP/0360 ZENECA AB LIMITED 20MG LE SODERTALJE- ORDINARY .0 TABLET
GARTUNAYEGEN, TABLETS BLISTER,1.
SODERTALJE 0X7.0
TABLET
BLISTER,1.
0X14.0
TABLET
CARTON
189 NDA/MAL/H SWISS SHREEJI BUPI BUPIVACAINE 5 MG/ML SWISS PARENTERALS LTD- INDIA PARENTERAL 1.0X20.0 7/1/2015
DP/0362 PARENTERALS PHARMACEUTIC 809 KERALA IND ESTATE ORDINARY ML VIAL
LTD ALS LIMITED GIDC NEAR BAVLA DIST VIALS
AHMEDABAD 382220
GUJARAT INDIA
190 NDA/MAL/H ABBOT HARLEYS KLACID CLARITHROM 250MG ABBOTT LABORATORIES SOUTH ORAL SOLID 1.0X10.0 7/1/1998
DP/0369 LABORATORIE UGANDA 250MG YCIN S.A (PTY) LTD-ABBOTT AFRICA ORDINARY TABLET
S S.A. (PTY) LIMITED PLACE,219 GOLF CLUB TABLETS BLISTER,1.
LTD TERRACE,CONSTANTIA 0X10.0X10
KLOOF 1709 P.O BOX 7208 .0 TABLET
WELTEVREDENPARK 1715 BLISTER
191 NDA/MAL/H MICRO LABS PHILLIPS NEBILONG- NEBIVOLOL + 5MG + MICRO LABS LTD-92, INDIA ORAL SOLID 1.0X3.0X1 7/1/2010
DP/0370 LTD PHARMACEUTIC H HYDROCHLOR 12.5MG SIPCOT INDUSTRIAL ORDINARY 0.0
ALS (UGANDA) OTHIAZIDE COMPLEX HOSU R-635126 TABLETS TABLET
192 NDA/MAL/H UNICHEM PHILLIPS LEZYNCET LEVOCETIRIZI 5MG UNICHEM LABORATORIES INDIA ORAL SOLID 1.0X2.0X1 7/1/2009
DP/0372 LABORATORIE PHARMACEUTIC NE LIMITED-UNICHEM ORDINARY 0.0
S LTD ALS (UGANDA) LABORATORIES LIMITED. FILM- TABLET
LIMITED UNIT II, VILLAGE COATED BLISTER,5.
BHATAULI KALAN, BADDI, TABLETS 0X2.0X10.
DIST. SOLAN PIN CODE 0 TABLET
173 205, HIMACHAL BLISTER
PRADESH, INDIA
193 NDA/MAL/H EMCURE HARLEYS ASOMEX-D AMLODIPINE 2.5 MG + EMCURE INDIA ORAL SOLID 1.0X3.0X1 7/1/2014
DP/0376 PHARMACEUT UGANDA + 12.5 MG PHARMACEUTICALS LTD- ORDINARY 0.0
ICALS LTD LIMITED HYDROCHLOR LANE NO.3 PHASE II SIDCO TABLETS TABLET
OTHIAZIDE INDUSTRIAL COMPLEX BLISTER
BARI BRAHMANA JAMMU
(J&K) 18113
194 NDA/MAL/H ASTRA LIFE ASTRA PHARMA ASFORMIN METFORMIN 500MG ASTRA LIFE CARE (INDIA) INDIA ORAL SOLID 1.0X10.0X 7/1/2015
DP/0385 CARE (INDIA) (U) LIMITED HYDROCHLOR PVT.LTD-PLOT NO. 57/P, ORDINARY 10.0
PVT LTD IDE SARKHEJ-BAVLA FILM- TABLET
AHMEDABAD INDIA
195 NDA/MAL/H EMCURE HARLEYS LOMOH-80 ENOXAPARIN 80MG/ EMCURE INDIA PARENTERAL 1.0X1.0 7/1/2014
DP/0386 PHARMACEUT UGANDA SODIUM 0.8ML PHARMACEUTICALS LTD - ORDINARY ML PRE-
ICALS LTD LIMITED PLOT NO. P-1 ITBT PARK PRE-FILLED FILLED
PHASE II MIDC HINJWADI SYRINGES SYRINGE
PUNE 411057
196 NDA/MAL/H KAMPALA KAMPALA AZUCLOX AMPICILLIN + 250 MG + KAMPALA UGANDA ORAL SOLID 1.0X10.0 7/1/1997
DP/0388 PHARMACEUT PHARMACEUTIC CLOXACILLIN 250 MG PHARMACEUTICAL ORDINARY CAPSULE
ICAL AL INDUSTRIES INDUSTRIES (1996) CAPSULES STRIP,1.0X
INDUSTRIES 1996 LIMITED LIMITED - -STRETCHER 250.0
1996 LIMITED ROAD PLOT M444B CAPSULE
NTINDA KAMPALA CONTAIN
ER,1.0X10
00.0
CAPSULE
CONTAIN
ER,1.0X50
0.0
197 NDA/MAL/H PT SANBE MEDVIN SANMOL PARACETAM 1000MG/1 PT SANBE FARMA JI INDONESIA PARENTERAL 1.0X100.0 7/1/2014
DP/0389 FARMA PHARMA INFUSION OL 00ML INDUSTRI-NO.8 KOMPLEKS ORDINARY ML
LIMITED IV INDUSTRI CIMAREME INFUSION BOTTLE
PADALARANG BANDUNG VIALS/BOTTL
ES
198 NDA/MAL/H LEBEN ANDYCO DOXYLEB DOXYCYCLINE 100MG LEBEN LABORATORIES PVT INDIA ORAL SOLID 1.0X10.0X 7/1/2014
DP/0394 LABORATORIE PHARMACY LTD --L4 PHASEIII M.I.D.C ORDINARY 10.0
S PVT.LTD (UGANDA) LTD AKOLA 444 104 CAPSULES CAPSULE
MAHARASHTRA BLISTER
199 NDA/MAL/H EMCURE HARLEYS ASOMEX-LT AMLODIPINE 2.5 MG + EMCURE INDIA ORAL SOLID 1.0X2.0X3 7/1/2013
DP/0397 PHARMACEUT UGANDA + LOSARTAN 50 MG PHARMACEUTICALS LTD- ORDINARY .0X10.0
ICALS LTD LIMITED POTASSIUM LANE NO.3 PHASE II SIDCO TABLETS TABLET
INDUSTRIAL COMPLEX BLISTER
BARI BRAHMANA JAMMU
(J&K) 18113
200 NDA/MAL/H CADILA ABACUS IBSOL 1.2 MESALAMINE 1.2GM CADILA HEALTHCARE INDIA ORAL SOLID 1.0X10.0X 7/1/2013
DP/0400 HEALTH CARE PHARMA DELAYED LIMITED--KUNDAIM RETARD 10.0
LIMITED (AFRICA) RELEASE INDUSTRIAL ESTATE, PLOT FILM- TABLET
LIMITED NO. 203-213, COATED BLISTER
KUNDAIM,GOA-403 115, TABLETS
INDIA
201 NDA/MAL/H NEON AIVEEN (U) SUPRIDOL TRAMADOL 50MG/ML NEON LABORATORIES LTD - INDIA PARENTERAL 1.0X2.0X5 7/1/2013
DP/0403 LABARATORIE LIMITED HYDROCHLOR -PLOT NO. 29, 30, 31, 32, ORDINARY I .0X1.0 ML
S LTD IDE 57 & 60, THE PALGHAR V AMPOULES AMPOULE
TALUKA - CO-OP ESTATE
LTD., BOISAR ROAD,
PALGHAR, DIST - THANE -
401404, MAHARASHTRA
202 NDA/MAL/H GLAXOSMITH UNITED ACTIFED TRIPLORIDINE 1.25MG/30 GLAXO WELLCOME EGYPT EGYPT ORAL LIQUID 1.0X100.0 7/1/1997
DP/0404 KLINE LTD HEALTHCARE WET HCL/PSEUDO MG/100M SAE.-EL SALAM CITY ORDINARY ML
DISTRIBUTORS COUGH & EPHEDRINE/G G 11491, CAIRO SYRUPS BOTTLE,1.
LTD COLD UAIPHENESIN 0X2.0 L
JERRYCAN
203 NDA/MAL/H NEON AIVEEN (U) CHEMLET LETROZOLE 2.5MG NEON LABORATORIES LTD- INDIA ORAL SOLID 1.0X10.0X 7/1/2013
DP/0405 LABARATORIE LIMITED PLOT NO. 29-32, 57 & 60, ORDINARY 10.0
S LTD PALGHAR TALUKA CO- TABLETS TABLET
OPERATIVE ESTATE , BLISTER
BOISAR ROAD
204 NDA/MAL/H NEON AIVEEN (U) EVATOCIN OXYTOCIN 10 I.U./ ML NEON LABORATORIES LTD- INDIA PARENTERAL 1.0X2.0X5 7/1/2015
DP/0406 LABARATORIE LIMITED PLOT NO. 29-32, 57 & 60, ORDINARY I .0X1.0 ML
S LTD PALGHAR TALUKA CO- V AMPOULES AMPOULE
OPERATIVE ESTATE ,
BOISAR ROAD
205 NDA/MAL/H NEON AIVEEN (U) NEOROF PROPOFOL 1%W/V NEON LABORATORIES LTD - INDIA PARENTERAL 1.0X20.0 7/1/2013
DP/0407 LABARATORIE LIMITED -PLOT NO. 29, 30, 31, 32, ORDINARY I ML
S LTD 57 & 60, THE PALGHAR V AMPOULES AMPOULE
LTD., BOISAR ROAD,
401404, MAHARASHTRA
206 NDA/MAL/H MSN METRO ALGIC - P ACECLOFENA 100 MG + MSN LABORATORIES LTD- INDIA ORAL SOLID 1.0X3.0X1 7/1/2013
DP/0408 LABORATORIE PHARMACEUTIC C+ 500 MG PLOT 42 ANRICH ORDINARY 0.0
S LTD ALS LIMITED PARACETAM INDUSTRIAL ESTATE FILM- TABLET
OL BOLLARAM MEDAK COATED BLISTER
PRADESH
207 NDA/MAL/H NEON AIVEEN (U) TYDE-S* CHLORAMPH 1G/VIAL NEON LABORATORIES LTD - INDIA PARENTERAL 1.0X1.0 G 7/1/2013
DP/0409 LABARATORIE LIMITED ENICOL -PLOT NO. 29, 30, 31, 32, ORDINARY VIAL
S LTD SODIUM 57 & 60, THE PALGHAR DRY VIALS
SUCCINATE TALUKA - CO-OP ESTATE
LTD., BOISAR ROAD,
401404, MAHARASHTRA
208 NDA/MAL/H MSN ABACUS LDNIL 20 ROSUVASTATI 20MG MSN LABORATORIES LTD- INDIA ORAL SOLID 1.0X3.0X1 7/1/2013
DP/0410 LABORATORIE PHARMA N CALCIUM PLOT N0.42, ANRICH ORDINARY 0.0
LIMITED LIMITED BLISTER
209 NDA/MAL/H BAYER SURGIPHARM JADELLE LEVONORGES 150MG BAYER OY-PANSIONATE 47 FINLAND PARENTERAL 1.0X10.0X 7/1/2003
DP/0411 PHARMA AG (U) LIMITED SINE TREL 20210 TURKU FINLAND RETARD 1.0X2.0X7
IMPLANTS 5.0 MG
IMPLANT
DP/0412 LABORATORIE PHARMA N CALCIUM PLOT N0.42, ANRICH ORDINARY 0.0
LIMITED LIMITED BLISTER
211 NDA/MAL/H NEON AIVEEN (U) XSPAS HYOSCINE 20MG/ML NEON LABORATORIES LTD - INDIA PARENTERAL 1.0X2.0X5 7/1/2013
DP/0413 LABARATORIE LIMITED BUTYLBROMI -PLOT NO. 29, 30, 31, 32, ORDINARY I .0X1.0 ML
S LTD DE 57 & 60, THE PALGHAR V AMPOULES AMPOULE
LTD., BOISAR ROAD,
401404, MAHARASHTRA
212 NDA/MAL/H SANDOZ SURGIPHARM RAMIPRIL RAMIPRIL 10MG LEK S.S POLAND UI POLAND ORAL SOLID 1.0X2.0X1 7/1/2014
DP/0414 GMBH, (U) LIMITED 10 MG PODLIPIE 16 95-01O ORDINARY 0.0
KUNDL TABLETS STRYKOW-INDUSTRIAL TABLETS TABLET
ESTATES BLISTER
213 NDA/MAL/H MACK SHURIK LTD RELEX DIPHENHYDR 14.03MG+ TORQUE INDIA ORAL LIQUID 1.0X100.0 7/1/1997
DP/0415 BROWN AMINE 138MG+57 PHARMACEUTICALS LTD - ORDINARY ML
PHARMECEUT HYDROCHLOR .03MG+0.9 ISSAPUR P.O DAPPAR SYRUPS BOTTLE
ICALS PVT LTD IDE+AMMONI 0MG 140506
UM
CHLORIDE+SO
DIUM
CITRATE+ME
NTHOL
214 NDA/MAL/H NOVARTIS SURGIPHARM RAMIZID 5 RAMIPRIL 5MG LEK S.A-95 - 010 POLAND ORAL SOLID 1.0X3.0X1 7/1/2014
DP/0416 PHARMA (U) LIMITED STRYKÓW, PODLIPIE 16, ORDINARY 0.0
SERVICES INC. POLAND TABLETS TABLET
BLISTER
215 NDA/MAL/H ASTRA MACNAUGHTON KOMBIGLYZ SAXAGLIPTIN 5MG + ASTRAZENECA UNITED ORAL SOLID 1.0X30.0 7/1/2013
DP/0418 ZENECA LIMITED E XR + 1000MG PHARMACEUTICALS LP.- STATES ORDINARY TABLET
5MG/1000 METFORMIN 4601 HIGHWAY 62 EAST TABLETS BOTTLE
MOUNT VERNON INDIANA
47620 USA
216 NDA/MAL/H ASTRAZENEC MACNAUGHTON KOMBIGLYZ SAXAGLIPTIN 2.5MG + ASTRAZENECA UNITED ORAL SOLID 1.0X60.0 7/1/2013
DP/0419 A LIMITED E XR + 1000MG PHARMACEUTICALS LP.- STATES ORDINARY TABLET
2.5MG/100 METFORMIN 4601 HIGHWAY 62 EAST TABLETS BOTTLE
0MG MOUNT VERNON INDIANA
47620 USA
217 NDA/MAL/H MSN METRO PREGASAFE PREGABALIN 150MG MSN LABORATORIES LTD- INDIA ORAL SOLID 1.0X3.0X1 7/1/2014
DP/0421 LABORATORIE PHARMACEUTIC 150 PLOT NO.42, ANRICH ORDINARY 0.0
S PRIVATE ALS LIMITED INDUSTRIAL ESTATE, CAPSULES CAPSULE
LIMITED BOLLARAM, INDIA BLISTER
218 NDA/MAL/H GITTOES GITTOES PARAFLAM IBUPROFEN + 100MG + AGOG PHARMA LTD-PLOT INDIA ORAL LIQUID 1.0X60.0 7/1/2013
DP/0422 PHARMACEUT PHARMACEUTIC PARACETAM 162.5MG NO.33,SECTOR ORDINARY ML
ICALS LIMITED ALS LIMITED OL /5ML II,VASAI,TALUKA INDL CO- SUSPENSION BOTTLE,1.
OP ESTATE LTD,GAURAI S 0X100.0
PADA,VASAI(E)DIST.THAN ML
E INDIA BOTTLE
219 NDA/MAL/H GITTOES GITTOES AGOTRAM TRAMADOL 50MG AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1.0X10.0X 7/1/2013
DP/0423 PHARMACEUT PHARMACEUTIC NO.33,SECTOR ORDINARY 10.0
ICALS LIMITED ALS LIMITED II,VASAI,TALUKA INDL CO- CAPSULES CAPSULE
PADA,VASAI(E)DIST.THAN 0X100.0X1
E INDIA 0.0
CAPSULE
BLISTER
220 NDA/MAL/H COSMOS LTD ASTRA PHARMA CHLORPRO CHLORPROM 25MG COSMOS LTD.-RANGWE KENYA ORAL SOLID 1.0X100.0 7/1/1998
DP/0424 (U) LIMITED MAZINE AZINE ROAD; OFF LUNGA LUNGA ORDINARY TABLET
TABLETS ROAD. P.O BOX 414 33, FILM- CONTAIN
B.P 25MG NAIROBI COATED ER,1.0X10
TABLETS 00.0
TABLET
CONTAIN
ER,10.0X1
0.0
TABLET
BLISTER
221 NDA/MAL/H MICRO LABS LABOREX AMLOZAAR - LOSARTAN 50MG + MICRO LABS LTD ..-57, INDIA ORAL SOLID 1.0X3.0X1 7/1/2015
DP/0427 LTD UGANDA H POTASSIUM + 5MG + SIPCOT INDUSTRIAL ORDINARY 0.0
LIMITED AMLODIPINE 12.5MG COMPLEX, HOSUR-635126, FILM- TABLET
BESILATE + TAMIIL NADU COATED BLISTER
HYDROCHLOR TABLETS
OTHIAZIDE
222 NDA/MAL/H MICRO LABS LABOREX MICROMOX- MOXIFLOXACI 400MG MICRO LABS LTD--NO 92, INDIA ORAL SOLID 1.0X3.0X5 7/1/2013
DP/0428 LTD UGANDA 400 N SIPCOT, HOSUR-635 126,, ORDINARY .0 TABLET
LIMITED TAMIL NADU, INDIA FILM- BLISTER
COATED
TABLETS
223 NDA/MAL/H ARISTO NORVIK FLEXON MR IBUPROFEN + 400MG + ARISTO INDIA ORAL SOLID 1.0X10.0X 7/1/2014
DP/0429 PHARMACEUT ENTERPRISES PARACETAM 325MG + PHARMACEUTICALS PVT. ORDINARY 10.0
ICALS PVT LTD LIMITED OL + 250MG LIMITED-PLOT NO. 208, TABLETS TABLET
CHLORZOXAZ NEW INDUSTRIAL AREA BLISTER
ONE NO. II, MANDIDEEP-
462046, DIST. - RAISEN,
MADHYA PRADESH,
INDIA.
224 NDA/MAL/H ARISTO NORVIK ARISTO ACECLOFENA 100MG+50 ARISTO INDIA ORAL SOLID 1.0X15.0X 7/1/2013
DP/0430 PHARMACEUT ENTERPRISES ACECLO C+PARACETA 0MG PHARMACEUTICALS PVT ORDINARY 10.0
ICALS PVT LTD LIMITED PLUS MOL LIMITED-PLOT 208, NEW FILM- TABLET
INDUSTRIAL AREA NO II, COATED BLISTER
MANDIDEEP-462 046 TABLETS
(DISTRICT) RAISEN,
225 NDA/MAL/H PT SAMBE MEDVIN PROANES PROPOFOL 1%W/V PT SANBE FARMA JI INDONESIA PARENTERAL 1.0X5.0X2 7/1/2014
DP/0433 FARMA PHARMA MCT/LCT INDUSTRI-NO.8 KOMPLEKS ORDINARY I 0.0 ML
LIMITED INDUSTRI CIMAREME V AMPOULES AMPOULE
PADALARANG BANDUNG
226 NDA/MAL/H LEBEN ANDYCO PROHIBIN OMEPRAZOLE 20MG LEBEN LABORATORIES PVT INDIA ORAL SOLID 1.0X10.0X 7/1/2010
S PVT LTD (UGANDA) LTD AKOLA 444 104 CAPSULES CAPSULE
MAHARASHTRA BLISTER,1.
0X10.0X10
.0
CAPSULE
STRIP
227 NDA/MAL/H PT SANBE MEDVIN SANBE POLY (0-2- 30G PT SANBE FARMA-JI INDONESIA PARENTERAL 1.0X500.0 7/1/2014
DP/0436 FARMA PHARMA HEST 130 HYDROXYETH LEUIGAJAH NO. 162 ORDINARY ML
LIMITED YL) STARCH CIMINDI, INDONESIA INFUSION BOTTLE
BAGS
228 NDA/MAL/H PT SANBE MEDVIN SANBE POLY (0-2- MW PT SANBE FARMA-JI INDONESIA PARENTERAL 1.0X500.0 7/1/2014
DP/0438 FARMA PHARMA HEST 200 HYDROXYETH 200,000 LEUIGAJAH NO. 162 ORDINARY ML
LIMITED YL) STARCH CIMINDI, INDONESIA INFUSION BOTTLE
BAGS
229 NDA/MAL/H AGIO ROYAL PHARMA AGICLOB- CLOBETASOL/ 0.5MG+3.4 AGIO PHARMACEUTICALS INDIA TOPICAL 1.0X15.0 7/1/2014
DP/0440 PHARMACEUT 2011 LIMITED GM GENTAMICIN MG+20MG LTD-PLOT NO. T-81, 82 EXTERNAL G TUBE
ICALS LTD /MICONAZOL /1G MIDC, BHOSARI, PUNE-26 CREAMS
E
230 NDA/MAL/H AGIO ROYAL PHARMA AGISEC SECNIDAZOLE 1GM AGIO PHARMACEUTICALS INDIA ORAL SOLID 1.0X2.0 7/1/2015
DP/0441 PHARMACEUT 2011 LIMITED LTD-PLOT NO. T-81, 82 ORDINARY TABLET
ICALS LTD MIDC, BHOSARI, PUNE-26 FILM- BLISTER
COATED
TABLETS
231 NDA/MAL/H AGIO ROYAL PHARMA AZIAGIO AZITHROMYCI 500MG AGIO PHARMACEUTICALS INDIA ORAL SOLID 1.0X3.0 7/1/2014
DP/0445 PHARMACEUT 2011 LIMITED 500 N LTD-PLOT NO. T-81, 82 ORDINARY TABLET
ICALS LTD MIDC, BHOSARI, PUNE-26 TABLETS BLISTER
232 NDA/MAL/H PT SANBE MEDVIN SANEXON® METHYLPRED 125MG/VI PT.CAPRIFARMINDO INDONESIA PARENTERAL 1.0X125.0 7/1/2014
DP/0447 FARMA PHARMA 125 NISOLONE AL LABORATORIES- ORDINARY MG VIAL
LIMITED SODIUM JI.INDUSTRI DRY VIALS + 1*2ML
SUCCINATE NO.8,KOMPLEKS INDUSTRI AMPOULE
CIMAREME DESA OF WFI
CIMAREME,KEC
PADALARANG,KAB
BANDUNG
233 NDA/MAL/H PHILLIPS PHILLIPS AMINOGUA CYANOCOBAL 5MCG STEDMAN INDIA ORAL SOLID 1.0X10.0X 7/1/2013
DP/0449 PHARMACEUT PHARMACEUTIC RD AMIN PHARMACEUTICALS PVT ORDINARY 5.0 G
ICALS LIMITED ALS (UGANDA) GRANULES LIMITED-NO. C-4, SIDCO GRANULES SACHET
LIMITED PHARMACEUTICAL
COMPLEX, ALATHUR,
THIRUPORUR,
KANCHEEPURAM DIST 603
110, TAMILNADU, INDIA
234 NDA/MAL/H PT SANBE MEDVIN SANEXON® METHYLPRED 500MG/VI PT.CAPRIFARMINDO INDONESIA PARENTERAL 1.0X500.0 7/1/2014
DP/0451 FARMA PHARMA 500 NISOLONE AL LABORATORIES- ORDINARY MG VIAL
LIMITED SODIUM JI.INDUSTRI DRY VIALS + 1*8ML
SUCCINATE NO.8,KOMPLEKS INDUSTRI AMPOULE
CIMAREME DESA OF WFI
CIMAREME,KEC
PADALARANG,KAB
BANDUNG
235 NDA/MAL/H PHILLIPS PHILLIPS AMINOGUA AMINO ACIDS MULTI STEDMAN INDIA ORAL LIQUID 1.0X200.0 7/1/2013
DP/0453 PHARMACEUT PHARMACEUTIC RD LIQUID + INGREDIEN PHARMACEUTICALS PVT ORDINARY ML
ICALS LIMITED ALS (UGANDA) MULTIVITAMI TS LIMITED-NO. C-4, SIDCO LIQUIDS BOTTLE
LIMITED NS PHARMACEUTICAL
COMPLEX, ALATHUR,
THIRUPORUR,
236 NDA/MAL/H PT SANBE MEDVIN LEVOCIN LEVOFLOXACI 500 MG PT SANBE FARMA JI INDONESIA PARENTERAL 1.0X100.0 7/1/2014
DP/0454 FARMA PHARMA INFUSION N INDUSTRI-NO.8 KOMPLEKS ORDINARY ML
LIMITED HEMIHYDRAT INDUSTRI CIMAREME INFUSION BOTTLE
E PADALARANG BANDUNG VIALS/BOTTL
ES
237 NDA/MAL/H LEBEN ANDYCO METROLEB METRONIDAZ 125MG/5 LEBEN LABORATORIES PVT INDIA ORAL LIQUID 1.0X100.0 7/1/2014
DP/0456 LABORATORIE PHARMACY OLE ML LTD --L4 PHASEIII M.I.D.C ORDINARY ML
S PVT. LTD (UGANDA) LTD AKOLA 444 104 SUSPENSION BOTTLE
MAHARASHTRA S
238 NDA/MAL/H UNIVERSAL DELMAW UNIBROL AMINOSIDINE 250MG UNIVERSAL CORPORATION KENYA ORAL SOLID 1.0X2.0X6 7/1/2012
DP/0457 CORPORATIO ENTERPRISES 250MG LTD-UNIVERSAL ORDINARY .0 TABLET
N LTD LIMITED CORPORATION LTD TABLETS BLISTER,1.
0X4.0X6.0
TABLET
BLISTER
239 NDA/MAL/H ARISTO NORVIK AMBRODIL AMBROXOL 7.5MG/ML ARISTO INDIA ORAL LIQUID 1.0X15.0 7/1/2009
DP/0460 PHARMACEUT ENTERPRISES HYDROCHLOR PHARMACEUTICALS PVT. ORDINARY ML
ICALS PVT LTD LIMITED IDE LIMITED-PLOT NO. 208, LIQUIDS BOTTLE
NEW INDUSTRIAL AREA
NO.II,MANDIDEEEP
PRADESH
240 NDA/MAL/H GITTOES GITTOES TOPHEN PHENYTOIN 100MG AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1.0X10.0X 7/1/2011
DP/0463 PHARMACEUT PHARMACEUTIC NO. 33, SECTOR II, VASAI, ORDINARY 10.0
ICALS LIMITED ALS LIMITED TALUKA INDL. CAPSULES CAPSULE
BLISTER,1.
0X100.0
CAPSULE
CONTAIN
ER,1.0X10
0.0X10.0
CAPSULE
BLISTER
241 NDA/MAL/H DAWA SUPER MEDIC CURAMOL PARACETAM 500MG/60 DAWA LTD -PLOT KENYA ORAL SOLID 50.0X2.0 7/1/1997
DP/0467 PHARMACEUT LTD PLUS OL/CAFFEINE MG NO.7879/8 BABA ROAD ORDINARY TABLET
ICALS LIMITED RUARAKA NAIROBI TABLETS STRIP
242 NDA/MAL/H NOVO PHILLIPS NOVOMIX INSULIN 100I.U/ML NOVO NORDISK A/S - DENMARK PARENTERAL 1.0X5.0X3 7/1/2014
DP/0470 NORDISK PHARMACEUTIC 30 FLEXPEN ASPART NOVO ALLE DK-2880 ORDINARY .0 ML
PHARMA ALS (UGANDA) BAGSVAERD DRY PRE- PREFILLED
GULF FZ-LC LIMITED FILLED PENS PEN
243 NDA/MAL/H NOVO PHILLIPS NOVORAPI INSULIN 100 I.U/ML NOVO NORDISK A/S - DENMARK PARENTERAL 1.0X5.0X3 7/1/2014
DP/0471 NORDISK PHARMACEUTIC D FLEXPEN ASPART NOVO ALLE DK-2880 ORDINARY .0 ML
PHARMA ALS (UGANDA) BAGSVAERD PRE-FILLED PREFILLED
GULF FZ-LC LIMITED PENS PEN
244 NDA/MAL/H SERUM NORVIK BCG BCG 1.33*1000 SERUM INSTITUTE OF INDIA PARENTERAL 1.0X1.0 7/1/2015
DP/0472 INSTITUTE OF ENTERPRISES VACCINE VACCINE(FRE 00 INDIA LTD-212/2 ORDINARY ML
INDIA LTD. LIMITED (FREEZE EZE DRIED) C.F.U/0.1M HADAPSAR, PUNE, 411028, DRY VIALS VIAL,1.0X
DRIED) L INDIA 0.5 ML
VIAL
245 NDA/MAL/H LINCOLN METRO TINI-500 TINIDAZOLE 500MG LINCOLN INDIA ORAL SOLID 1.0X25.0X 7/1/2015
DP/0475 PHARMACEUT PHARMACEUTIC PHARMACEUTICALS ORDINARY 4.0
KHATRAJ CHOKADI,
KHATRAJ-382721,
GHANDHINAGAR,
GUJARAT, INDIA
246 NDA/MAL/H LINCOLN METRO VOMISTAT- ONDANSETR 4MG LINCOLN INDIA ORAL SOLID 1.0X10.0X 7/1/2014
DP/0477 PHARMACEUT PHARMACEUTIC 4 ON PHARMACEUTICALS ORDINARY 10.0
KHATRAJ CHOKADI,
KHATRAJ-382721,
GHANDHINAGAR,
GUJARAT, INDIA
247 NDA/MAL/H CIPLA LTD QUALITY EFAVIRENZ, EFAVIRENZ + 600MG+30 CIPLA QUALITY CHEMICAL INDIA ORAL SOLID 1.0X30.0 7/1/2014
DP/0480 CHEMICALS LTD - LAMIVUDIN LAMIVUDINE 0MG+300 INDUSTRIES LIMITED - - ORDINARY TABLET
HUMAN E& + TENOFOVIR MG PLOT 1-7 1ST RING ROAD, FILM- CONTAIN
TENOFOVIR DISOPROXIL LUZIRA, KAMPALA CIPLA COATED ER
DISOPROXIL FUMARATE L.T.D -MIDC PATALGANGA TABLETS
FUMERATE MAHARASHTRA 410 220
600/300/30 CIPLA LTD UNIT VII PD II-S-
0 MG 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
248 NDA/MAL/H LEBEN ANDYCO AZILEB-500 AZITHROMYCI 500MG LEBEN LABORATORIES PVT INDIA ORAL SOLID 1.0X20.0X 7/1/2014
DP/0482 LABORATORIE PHARMACY N LTD --L4 PHASEIII M.I.D.C ORDINARY 3.0
S PVT. LTD., (UGANDA) LTD AKOLA 444 104 FILM- TABLET
INDIA MAHARASHTRA COATED BLISTER
TABLETS
249 NDA/MAL/H FOUNTIL LIFE PHILLIPS ULGICID ALGINIC 200MG + STEDMAN INDIA ORAL SOLID 1.0X3.0X1 7/1/2013
DP/0483 SCIENCES PVT PHARMACEUTIC TABLETS ACID+ 250MG + PHARMACEUTICALS PVT ORDINARY 0.0
LTD ALS (UGANDA) MAGNESIUM 250MG + LIMITED-NO. C-4, SIDCO CHEWABLE TABLET
LIMITED HYDROXIDE+ 250MG + PHARMACEUTICAL TABLETS STRIP
ALUMINIUM 125MG COMPLEX, ALATHUR,
HYDROXIDE+ THIRUPORUR,
MAGNESIUM KANCHEEPURAM DIST 603
TRISILICATE + 110, TAMILNADU, INDIA
SIMETICONE
250 NDA/MAL/H KAMPALA KAMPALA PILPLAN ETHINYL 0.03MG+0. BAYER SCHERING GERMANY ORAL SOLID 1.0X10.0X 7/1/2014
DP/0484 PHARMACEUT PHARMACEUTIC PLUS ESTRADIOL + 15MG/75 PHARMA AG.-13342, ORDINARY 3.0X28.0
ICAL AL INDUSTRIES LEVONORGES MG BERLIN TABLETS TABLET
INDUSTRIES 1996 LIMITED TREL / BLISTER
(1996) LTD FERROUS
FUMARATE
251 NDA/MAL/H LEBEN ANDYCO CEBAY-200 CEFIXIME 200MG LEBEN LABORATORIES PVT INDIA ORAL SOLID 1.0X10.0 7/1/2014
DP/0489 LABORATORIE PHARMACY DT LTD --L4 PHASEIII M.I.D.C ORDINARY TABLET
S PVT.LTD (UGANDA) LTD AKOLA 444 104 SOLUBLE BLISTER
MAHARASHTRA TABLETS
252 NDA/MAL/H SANOFI SURGIPHARM ORELOX CEFPODOXIM 200MG SANOFI WINTHROP FRANCE ORAL SOLID 1.0X1.0X1 7/1/2013
DP/0490 (U) LIMITED E INDUSTRIE-SANOFI ORDINARY 0.0
WINTHROP INDUSTRIE TABLETS TABLET
56, RUE DE CHOISY AU BLISTER
BAC
60205 COMPIÈGNE
253 NDA/MAL/H ABACUS ABACUS ABCHLOR CHLORAMPH 0.5% W/V ABACUS PARENTERAL UGANDA OPHTHALMI 1.0X5.0 7/1/2013
DP/0491 PARENTERAL PARENTERAL EYE DROPS ENICOL DRUGS LTD-PLOT NO. 114, C DROPS ML
DRUGS DRUGS LIMITED BLOCK 191, GWAGAMYA, VIAL,1.0X
LIMITED KINGA, KAPEKE, 10.0 ML
MUKONO VIAL
254 NDA/MAL/H MSN ABACUS PRASUSAFE PRASUGREL 10MG MSN LABORATORIES LTD- INDIA ORAL SOLID 1.0X3.0X1 7/1/2013
DP/0493 LABORATORIE PHARMA 10 PLOT 42 ANRICH ORDINARY 0.0
PRADESH
255 NDA/MAL/H ADCOCK UGANDA MYPRODOL PARACETAM 250MG + ADCOCK INGRAM LIMITED INDIA ORAL SOLID 1.0X20.0 7/1/2014
DP/0496 INGRAM HEALTH OL + 200MG + -49C & D BOMMASANDRA ORDINARY CAPSULE
LIMITED MARKETING IBUPROFEN + 10MG INDUSTRIAL AREA ANEKAL CAPSULES BLISTER,1.
GROUP LIMITED CODEINE TALUK, BANGALORE 0X3.0X10.
PHOSPHATE 0
560099, KARNATAKA CAPSULE
STATE, INDIA BLISTER
256 NDA/MAL/H LABORATORY HARLEYS KEMOXYL AMOXYCILLIN 125MG/5 LABORATORY & ALLIED KENYA ORAL LIQUID 1.0X100.0 7/1/2014
DP/0497 &ALLIED LTD UGANDA DRY TRIHYDRATE ML LTD-PLOT NO. 209/10349 ORDINARY ML
LIMITED SUSPENSIO OFF MOMBASA ROAD, DRY BOTTLE
N NAIROBI SUSPENSION
P.O. BOX 42875, NAIROBI, S/SYRUPS/D
KENYA. ROPS
257 NDA/MAL/H STEDMAN VEERAM DREZ IODINATED 2%W/V STEDMAN INDIA ORAL LIQUID 1.0X50.0 7/1/2013
DP/0502 PHARMACEUT HEALTHCARE GARGLE POVIDONE PHARMACEUTICALS PVT ORDINARY ML
ICALS LTD (U) LIMITED LIMITED-NO. C-4, SIDCO LIQUIDS BOTTLE,1.
PHARMACEUTICAL 0X100.0
COMPLEX, ALATHUR, ML
THIRUPORUR, BOTTLE
258 NDA/MAL/H GLENMARK STAR LIZOLID-600 LINEZOLID 600MG GLENMARK INDIA ORAL SOLID 1.0X5.0X4 7/1/2004
DP/0510 PHARMACEUT PHARMACEUTIC PHARMACEUTICALS LTD- ORDINARY .0 TABLET
ICAL LTD ALS LTD PLOT NO E -37, 39 ,D TABLETS STRIP
259 NDA/MAL/H SANOFI LABOREX SHANVAC - R- DNA 20MCG/ML SHANTHA BIOTECHNICS INDIA PARENTERAL 1.0X35.0X 7/1/2015
DP/0517 AVENTIS UGANDA B HEPATITIS -B LTD -SURVEY NO. 274, ORDINARY 1.0 ML
KENYA LTD LIMITED SURFACE ATHVELLI VILLAGE, VIALS VIAL (1
ANTIGEN MEDCHAL MANDAL – ADULT
PURIFIED 501401, RANGA REDDY DOSE),1.0
DISTRICT, ANDHRA X35.0X0.5
PRADESH, INDIA ML VIAL
(1
PEDIATRIC
DOSE)
260 NDA/MAL/H RENE RENE CYCLOREN ACICLOVIR 200MG RENE INDUSTRIES LTD- UGANDA ORAL SOLID 1.0X10.0X 7/1/2006
LTD LIMITED KIREKA, P.O BOX 6034, TABLETS TABLET
KAMPALA STRIP
261 NDA/MAL/H ALKEM ABACUS PAN 40 PANTOPRAZO 40MG ALKEM LABORATORIES INDIA ORAL SOLID 1.0X10.0 7/1/2014
DP/0521 LABORATORIE PHARMA LE SODIUM LTD .- VILLAGE THANA ORDINARY TABLET
S LIMITED (AFRICA) BADDI TEHSIL NALAGARH ENTERIC- BLISTER,1.
LIMITED DIST SOLAN HIMACHAL COATED 0X3.0X10.
PRADESH TABLETS 0 TABLET
BLISTER
262 NDA/MAL/H MEDLEY MEDVIN VAZORTAN LOSARTAN 50MG MEDLEY INDIA ORAL SOLID 1.0X10.0X 7/1/2015
DP/0522 PHARMACEUT PHARMA 50 POTASSIUM PHARMACEUTICALS LTD - ORDINARY 10.0
ICALS LTD LIMITED PLOT NO. 18 AND 19, FILM- TABLET
SURVEY NO. 378/8 & COATED BLISTER
379/2, KEBRA INDUSTRIAL TABLETS
ESTATE, KACHIGAM
,
DAMAN-396 210, INDIA
263 NDA/MAL/H LEBEN ANDYCO AMILEB- 25 AMITRIPTYLI 25MG LEBEN LABORATORIES INDIA ORAL SOLID 1.0X10.0X 7/1/2014
DP/0526 LABORATORIE PHARMACY NE PVT. LTD-PLOT NO. L-4, ORDINARY 20.0
S LTD (UGANDA) LTD PHASE-III, MIDC, TABLETS TABLET
AKOLA– 444 104 (MS). BLISTER,1.
0X10.0X10
.0 TABLET
BLISTER
264 NDA/MAL/H ABACUS ABACUS CLARY 500 CLARITHROM 500MG LINCOLN INDIA ORAL SOLID 1.0X10.0X 7/1/2013
DP/0528 PARENTERAL PHARMA YCIN PHARMACEUTICALS LTD .- ORDINARY 10.0
DRUGS (AFRICA) 10,12,13 TRIMUL ESTATE, TABLETS TABLET
LIMITED LIMITED NEAR KHATRAJ CHOKADI, BLISTER
KALOL, DIST.
265 NDA/MAL/H LEBEN ANDYCO ENDERM- CLOBETASOL 0.05%W/W LEBEN LABORATORIES INDIA TOPICAL 1.0X30.0 7/1/2014
DP/0531 LABORATORIE PHARMACY GM PROPIONATE + PVT. LTD.-PLOT NO. L-4, EXTERNAL G
S LTD (UGANDA) LTD + 0.10%W/W PHASE –III, M.I.D.C, CREAMS TUBE,1.0X
GENTAMYCIN + AKOLA, 444104, 15.0 G
+ 2.0%W/W MAHARASHTRA, INDIA. TUBE
MICONAZOLE
NITRATE
266 NDA/MAL/H ABACUS ABACUS SARTAN-50 LOSARTAN 50MG LINCOLN INDIA ORAL SOLID 1.0X3.0X1 7/1/2013
DP/0532 PARENTERAL PARENTERAL POTASSIUM PHARMACEUTICALS LTD .- ORDINARY 0.0
DRUGS DRUGS LIMITED 10,12,13 TRIMUL ESTATE, FILM- TABLET
LIMITED NEAR KHATRAJ CHOKADI, COATED BLISTER
P.O. KHATRAJ-382721 TA: TABLETS
KALOL, DIST.
267 NDA/MAL/H MYLAN KIMSY MEDS TELKAST 5 MONTELUKAS 5MG MSN LABORATORIES LTD- INDIA ORAL SOLID 1.0X3.0X1 7/1/2013
DP/0533 PHARMACEUT LTD T SODIUM PLOT 42 ANRICH ORDINARY 0.0
ICAL PRIVATE INDUSTRIAL ESTATE CHEWABLE TABLET
LIMITED, BOLLARAM MEDAK TABLETS BLISTER
INDIA DISTRICT 502325 ANDHRA
PRADESH
268 NDA/MAL/H MICRO LABS LABOREX XONADINE FEXOFENADI 180 MG MICRO LABS LTD--NO 92, INDIA ORAL SOLID 1.0X3.0X1 7/1/2013
DP/0538 LTD UGANDA 180 NE SIPCOT, HOSUR-635 126,, ORDINARY 0.0
LIMITED HYDROCHLOR TAMIL NADU, INDIA TABLETS TABLET
IDE BLISTER,1.
0X1.0X10.
0 TABLET
BLISTER
269 NDA/MAL/H ABACUS ABACUS HYDRICORT HYDROCORTI 100MG LINCOLN PARENTERAL LTD- INDIA PARENTERAL 1.0X50.0X 7/1/2014
DP/0540 PARENTERAL PARENTERAL SONE 11, TRIMUL ESTATE, NEAR ORDINARY 100.0 MG
DRUGS DRUGS LIMITED SODIUM KHATRAJ CHOLADI, P.O. DRY VIALS VIAL
LIMITED SUCCINATE KHATRAJ-382721 TA:
KALOL, DIST.
270 NDA/MAL/H MICRO LABS LABOREX XONADINE FEXOFENADI 120MG MICRO LABS LTD--NO 92, INDIA ORAL SOLID 1.0X3.0X1 7/1/2013
DP/0541 LTD UGANDA 120 NE SIPCOT, HOSUR-635 126,, ORDINARY 0.0
LIMITED HYDROCHLOR TAMIL NADU, INDIA TABLETS TABLET
IDE BLISTER
271 NDA/MAL/H DAWA SUPER MEDIC PHENBITAL PHENOBARBI 30MG DAWA LTD-BABA DOGO KENYA ORAL SOLID 1.0X10.0X 7/1/2014
DP/0542 LIMITED LTD TAL ROAD RUARAKA ORDINARY 10.0
TABLETS TABLET
BLISTER
272 NDA/MAL/H UNITED WIDE GLIMERYL 2 GLIMEPIRIDE 2MG UNITED JORDAN ORAL SOLID 1.0X3.0X1 7/1/2013
DP/0543 PHARMACEUT SPECTRUM PHARMACEUTICAL ORDINARY 0.0
ICAL ENTERPRISES MANUFACTURING TABLETS TABLET
MANUFACTU (U) LIMITED COMPANY LTD-P.O BOX BLISTER
RING 69 AMMAN 11591
COMPANY JORDAN NUZHAT SAHAB
LTD AL-RAQEEM NERA PUBLIC
SECURITY HOUSING
273 NDA/MAL/H MICRO LABS LABOREX DOLOWIN ACECLOFENA 100 MG + MICRO LABS LTD-92, INDIA ORAL SOLID 1.0X3.0X1 7/1/2013
DP/0544 LIMITED UGANDA PLUS C+ 500 MG SIPCOT INDUSTRIAL ORDINARY 0.0
LIMITED PARACETAM COMPLEX HOSU R-635126 TABLETS TABLET
OL (T.N) INDIA BLISTER
274 NDA/MAL/H NAARI LTD ECHO MISO-KARE MISOPROSTO 200MCG NAARI PHARMA PRIVATE INDIA ORAL SOLID 1.0X5.0 7/1/2013
DP/0547 PHARMACY (U) L LIMITED-PLOT NO. 14-16 ORDINARY TABLET
LIMITED &55-57, SECTOR-5, IIE, TABLETS BLISTER
PANTNAGAR, RUDRAPUR- (COMBIPA
263153, DIST. U.S. NAGAR, CK)
UTTARAKHAND, INDIA
275 NDA/MAL/H UNITED WIDE UNICAST MONTELUKAS 5MG UNITED JORDAN ORAL SOLID 1.0X3.0X1 7/1/2012
DP/0548 PHARMACEUT SPECTRUM T PHARMACEUTICAL ORDINARY 0.0
ICAL ENTERPRISES MANUFACTURING CHEWABLE TABLET
MANUFACTU (U) LIMITED COMPANY LTD .--P.O BOX TABLETS BLISTER
RING 69 AMMAM 11591
COMPANY JORDAN NUZHAT SAHID
LIMITED AL-RAQEEM NEAR PUBLIC
HOUSING SECURITY
276 NDA/MAL/H DAWA SUPER MEDIC DA-ZEPAM DIAZEPAM 5MG DAWA LTD -PLOT KENYA ORAL SOLID 1.0X10.0X 7/1/2014
RUARAKA NAIROBI TABLETS TABLET
BLISTER,1.
0X1000.0
TABLET
CONTAIN
ER
277 NDA/MAL/H SAKAR ROYAL PHARMA REDAMOX AMOXICILLIN 125 MG/ 5 SAKAR HEALTH CARE PVT, INDIA ORAL LIQUID 1.0X100.0 7/1/2014
DP/0551 HEALTH CARE 2011 LIMITED + ML + 31.25 LTD-BLOCK NO. 10-13,M.N ORDINARY ML
PVT .LTD CLAVULANIC MG/ 5 ML DESAI PETROL DRY BOTTLE
ACID PUMP,SARKHEJ-BAVLA SUSPENSION
CHANGODAR DIST ROPS
AHMEDABAD 382-
213,GUJARAT-INDIA
278 NDA/MAL/H BHARAT ABACUS EQUIRAB RABIES 1000IU/ BHARAT SERUMS AND INDIA PARENTERAL 1.0X1.0X5 7/1/2013
DP/0553 SERUMS AND PHARMA ANTISERUM 5ML VACCINES LIMITED,-PLOT ORDINARY .0 ML
VACCINES LTD (AFRICA) NO. K-27, ADDITIONAL VIALS VIAL (5
LIMITED MIDC, DOSE
AMBERNATH (EAST), VIAL)
INDIA
279 NDA/MAL/H HOVID BHD UNITED CARZEPIN CARBAMAZEP 200MG HOVID BHD-LOT MALAYSIA ORAL SOLID 1.0X10.0X 7/1/2013
DP/0555 HEALTHCARE INE 56442,71/2 MILES JALAN ORDINARY 10.0
DISTRIBUTORS IPOH,PERAK,MALAYSIA TABLETS TABLET
LTD BLISTER
280 NDA/MAL/H SAKAR ROYAL PHARMA REDAMOX AMOXICILLIN 250 MG/5 SAKAR HEALTH CARE PVT, INDIA ORAL LIQUID 1.0X100.0 7/1/2013
DP/0557 HEALTH CARE 2011 LIMITED 312.5 + POTASSIUM ML + 62.5 LTD-BLOCK NO. 10-13,M.N ORDINARY ML
PVT .LTD CLAVULANAT MG/5 ML DESAI PETROL DRY BOTTLE
E PUMP,SARKHEJ-BAVLA SUSPENSION
CHANGODAR DIST ROPS
AHMEDABAD 382-
213,GUJARAT-INDIA
281 NDA/MAL/H ABACUS ABACUS ABGENTA GENTAMICIN 0.3% W/V ABACUS PARENTERAL UGANDA OPHTHALMI 1.0X10.0 7/1/2014
DP/0558 PARENTERAL PARENTERAL EYE DROPS SULPHATE DRUGS LIMITED-BLOCK C DROPS ML
DRUGS DRUGS LIMITED 191, PLOT NO. 114, BOTTLE
KAPEKA MUKONO
DISTRICT, UGANDA.
282 NDA/MAL/H HOVID BHD MEDICAL DIABETMIN METFORMIN 850MG HOVID BHD-LOT MALAYSIA ORAL SOLID 1.0X10.0X 7/1/2014
DP/0559 ACCESS RETARD HYDROCHLOR 56442,71/2 MILES JALAN RETARD 10.0
(UGANDA) IDE IPOH,PERAK,MALAYSIA TABLETS TABLET
LIMITED BLISTER
283 NDA/MAL/H UNITED WIDE GLIMERYL 1 GLIMEPIRIDE 1MG UNITED JORDAN ORAL SOLID 1.0X3.0X1 7/1/2013
DP/0560 PHARMACEUT SPECTRUM PHARMACEUTICAL ORDINARY 0.0
ICAL ENTERPRISES MANUFACTURING TABLETS TABLET
MANUFACTU (U) LIMITED COMPANY LTD .--P.O BOX BLISTER
RING 69 AMMAM 11591
COMPANY JORDAN NUZHAT SAHID
LTD AL-RAQEEM NEAR PUBLIC
HOUSING SECURITY
284 NDA/MAL/H IND SWIFT PLANET EZO 40 ESOMEPRAZO 40MG IND-SWIFT-LTD,-GLOBAL INDIA ORAL SOLID 1.0X10.0X 7/1/2013
DP/0563 LTD PHARMACEUTIC LE BUSINESS UNIT, RETARD 10.0
ALS UGANDA MAGNESIUM JAWAHARPUR, OFF NH-21 TABLETS TABLET
LTD DERABASSI BLISTER
285 NDA/MAL/H SAKAR ROYAL PHARMA CEFROTIL CEFUROXIME 125MG/5 SAKAR HEALTHCARE PVT. INDIA ORAL LIQUID 1.0X1.0X5 7/1/2013
DP/0566 HEALTH CARE 2011 LIMITED SUSPENSIO AXETIL ML LTD-PLOT 10/13 SAKHEJ- ORDINARY 0.0 ML
PVT .LTD N BAVLA ROAD, SOLUBLE BOTTLE
AHMEDABAD,GUJURAT,IN POWDERS
DIA
286 NDA/MAL/H KOTRA ABACUS VAXCEL CEFTRIAXONE 500MG KOTRA PHARMA SDN BDN- MALAYSIA PARENTERAL 1.0X500.0 7/1/2013
DP/0567 PHARMA SDN PHARMA CEFTRIAZO 1, 2, &3, JALANTTC12 ORDINARY MG VIAL
BDN (AFRICA) NE 500MG CHENG INDUSTRIAL DRY VIALS
LIMITED ESTATE, 75250, MELAKA,
MALAYSIA
287 NDA/MAL/H RENE RENE FLUOXIREN FLUOXETINE 20MG RENE INDUSTRIES LIMITED- UGANDA ORAL SOLID 1.0X10.0X 7/1/2013
LTD LIMITED KIREKA CAPSULES CAPSULE
BLISTER
288 NDA/MAL/H KOTRA ABACUS AXCELLRIDI PHOLCODINE 10MG/5ML KOTRA PHARMA (M) SDN. MALAYSIA ORAL LIQUID 1.0X90.0 7/1/2014
DP/0569 PHARMA SDN PHARMA N LINCTUS BHD-1 JALAN TTC 12, ORDINARY ML
BDN (AFRICA) CHENG INDUSTRIAL SYRUPS BOTTLE
LIMITED ESTATE, 75250 MELAKA
MALYSIA
289 NDA/MAL/H BHARAT ABACUS TETGLOB HUMAN 250IU BHARAT SERUMS AND INDIA PARENTERAL 1.0X1.0X2 7/1/2013
DP/0570 SERUMS AND PHARMA 250 I.U TETANUS VACCINES LIMITED,-PLOT ORDINARY I .0 ML
VACCINES LTD (AFRICA) IMMUNOGLO NO. K-27, ADDITIONAL M VIALS VIAL (1
LIMITED BULIN MIDC, DOSE
AMBERNATH (EAST), VIAL)
INDIA
290 NDA/MAL/H KOTRA ABACUS AXCEL LIGHT KAOLIN 1G + KOTRA PHARMA (M) SDN. MALAYSIA ORAL LIQUID 1.0X120.0 7/1/2015
DP/0571 PHARMA (M) PHARMA KAOPEC + PECTIN 20MG/5ML BHD-1 JALAN TTC 12, ORDINARY ML
SDN BHD (AFRICA) (CITRUS) CHENG INDUSTRIAL SUSPENSION BOTTLE
LIMITED ESTATE, 75250 MELAKA S
MALYSIA
291 NDA/MAL/H NORVATIS LABOREX AZARGA BRINZOLAMI 10MG/ML ALCON COUVREUR NV- BELGIUM OPHTHALMI 1.0X5.0 7/1/2010
DP/0572 PHARMA AG- UGANDA DE + + 5MG/ML RIJKSWEG 14, B-2870 C DROPS ML VIAL
SWITZERLAN LIMITED TIMOLOL PUURS BELGIUM
D
292 NDA/MAL/H KOTRA ABACUS AXCEL PARACETAM 250MG/5 KOTRA PHARMA (M) SDN. MALAYSIA ORAL LIQUID 1.0X60.0 7/1/2014
DP/0573 PHARMA (M) PHARMA PARACETA OL ML BHD-1 JALAN TTC 12, ORDINARY ML
SDN,BHD (AFRICA) MOL-250 CHENG INDUSTRIAL SUSPENSION BOTTLE,1.
LIMITED ESTATE, 75250 MELAKA S 0X100.0
MALYSIA ML
BOTTLE
293 NDA/MAL/H IPCA MEDVIN ARTESUNA ARTESUNATE 100MG+27 IPCA LABORATORIES INDIA ORAL SOLID 1.0X1.0X3 7/1/2013
DP/0574 LABORATOIES PHARMA TE AND AND 0MG LIMITED -SEJAVTA ORDINARY .0 TABLET
LTD LIMITED AMODIAQU AMODIAQUIN VILLAGE, DIST. RATLAM TABLETS BLISTER,1.
INE E (M.P) 457002 0X1.0X6.0
TABLETS INDIA. TABLET
100/270 BLISTER
294 NDA/MAL/H GLAXO SMITH UNITED DUODART DUTASTERIDE 0.5MG + CATALENT GERMANY GERMANY ORAL SOLID 1.0X30.0 7/1/2015
DP/0576 KLINE LTD HEALTHCARE + 0.4MG SCHONDORF GMBH - ORDINARY CAPSULE
DISTRIBUTORS TAMSULOSIN STEINBEISSTRASSE 1-2, CAPSULES CONTAIN
LTD 73614 SCHORNDORF, ER
GERMANY
295 NDA/MAL/H TROIKAA ABACUS XYKAA PARACETAM 650MG TROIKAA INDIA ORAL SOLID 1.0X10.0X 7/1/2014
DP/0577 PHARMACEUT PHARMA EXTENDED OL PHARMACUETICALS ORDINARY 10.0
ICALS LIMITED (AFRICA) LIMITED-C-1 SARA OTHER TABLET
LIMITED INDUSTRIAL ESTATE, COATED BLISTER
SELAQUI, DEHRADUN- TABLETS
248197, UTTARAKHAND,
INDIA
296 NDA/MAL/H KAMPALA KAMPALA FLUCAP MULTINGRED MULTINGR KAMPALA UGANDA ORAL SOLID 1.0X10.0X 7/1/1997
DP/0580 PHARMACEUT PHARMACEUTIC IENT EDIENT PHARMECEUTICALS ORDINARY 10.0
ICAL AL INDUSTRIES INDUSTRIES LTD.-PLOT CAPSULES CAPSULE
INDUSTRIES 1996 LIMITED M444B STRETCHER RD, BLISTER
(1996) LTD NTINDA KLA UGANDA
297 NDA/MAL/H ARISTO NORVIK ACECLO ACECLOFENA 100MG + ARISTO INDIA ORAL SOLID 1.0X10.0X 7/1/2015
DP/0582 PHARMACEUT ENTERPRISES SERA C+PARACETA 500MG + PHARMACEUTICALS PVT ORDINARY 10.0
ICALS PVT LTD LIMITED MOL+SERRAT 15MG LTD-VILLAGE: FILM- TABLET
IOPEPTIDASE MAKHNUMAJRA P.O. COATED BLISTER,1.
BHUD BADDI DISTRIC: TABLETS 0X10.0X10
SOLAN (H.P) 173205 .0 TABLET
BLISTER
298 NDA/MAL/H ARISTO NORVIK TRIGLIMIPR GLIMEPIRIDE 1MG+15M ARISTO INDIA ORAL SOLID 1.0X3.0X1 7/1/2014
DP/0584 PHARMACEUT ENTERPRISES EX 1 +PIOGLITAZO G+500MG PHARMACEUTICALS PVT ORDINARY 0.0
ICALS PVT LTD LIMITED NE+METFOR LTD---VILLAGE TABLETS TABLET
MIN MAKHNUMAJRA P.O BLISTER,1.
HYDROCHLOR BHUD BADDI DISTRICT 0X10.0X10
IDE SOLAN (H.P) 173205 .0 TABLET
BLISTER
299 NDA/MAL/H CADILA ESCORTS ONSETT ONDANSETR 2MG/ML CADILA INDIA PARENTERAL 1.0X5.0X2 7/1/2013
DP/0586 PHARMACEUT PHARMACEUTIC ON PHARMACEUTICALS ORDINARY .0 ML
ICALS LIMITED ALS LIMITED LIMITED-1389, TRASAD AMPOULES AMPOULE
ROAD, DHOLKA- 382225, ,1.0X5.0X4
DIST: AHMEDAD, GUJARAT .0 ML
STATE, INDIA AMPOULE
300 NDA/MAL/H CADILA ESCORTS CADIGREL CLOPIDOGREL 75MG CADILA INDIA ORAL SOLID 1.0X3.0X1 7/1/2013
ICALS LIMITED ALS LIMITED LIMITED-1389, TRASAD FILM- TABLET
ROAD, DHOLKA- 382225, COATED BLISTER
DIST: AHMEDAD, GUJARAT TABLETS
STATE, INDIA
301 NDA/MAL/H AUROLAB SWASTIK AUROFORT PREDNISOLO 1%W/V AUROLAB-NO 1 INDIA OPHTHALMI 1.0X5.0 7/1/2013
DP/0588 PHARMACEUTIC NE ACETATE SIVAGANGAI MAIN ROAD, C ML
AL LTD VEERAPANJAN MADURAI SUSPENSION BOTTLE
– 625 020 TAMIL NADU, S
INDIA
302 NDA/MAL/H ARISTO NORVIK TRIGLIMIPR GLIMEPIRIDE 2MG+15M ARISTO INDIA ORAL SOLID 1.0X3.0X1 7/1/2014
DP/0589 PHARMACEUT ENTERPRISES EX 2 +PIOGLITAZO G+500MG PHARMACEUTICALS PVT ORDINARY 0.0
ICALS PVT LTD LIMITED NE+METFOR LTD---VILLAGE TABLETS TABLET
MIN MAKHNUMAJRA P.O BLISTER,1.
HYDROCHLOR BHUD BADDI DISTRICT 0X10.0X10
IDE SOLAN (H.P) 173205 .0 TABLET
BLISTER
303 NDA/MAL/H BHARAT ABACUS ASNA B.GABONICA/ 25/25/20/ BHARAT SERUMS AND INDIA PARENTERAL 1.0X1.0X1 7/1/2012
DP/0590 SERUMS AND PHARMA ANTIVENO B.ARIENTANS 25/25/25/ VACCINES LIMITED,-PLOT ORDINARY 0.0 ML
VACCINES LTD (AFRICA) MC / 25/25/20/ NO. K-27, ADDITIONAL VIALS VIAL
LIMITED B.NASICORNI 25/20/25 MIDC,
S/ I.U AMBERNATH (EAST),
DENDROASPI INDIA
S/
POLYEPIS/D.A
NGUSTICEPS/
N.NIVEA
/N.NLGRCOLL
IS/N.HAJE
304 NDA/MAL/H AUROLAB SWASTIK AUROCHRO CROMOLYN 2%W/V AUROLAB-NO 1 INDIA OPHTHALMI 1.0X10.0 7/1/2013
DP/0592 PHARMACEUTIC ME SODIUM SIVAGANGAI MAIN ROAD, C LIQUIDS ML
AL LTD VEERAPANJAN MADURAI CONTAIN
– 625 020 TAMIL NADU, ER
INDIA
305 NDA/MAL/H ARISTO NORVIK PANTOP-D PANTOPRAZO 20MG+10 ARISTO INDIA ORAL SOLID 1.0X10.0X 7/1/2014
DP/0593 PHARMACEUT ENTERPRISES LE SODIUM MG PHARMACEUTICALS PVT ORDINARY 10.0
ICALS PVT LTD LIMITED SESQUIHYDR LTD .-MAKHNUMAJRA P.O ENTERIC- CAPSULE
ATE + BHUD BADDI DISTRICT COATED STRIP,1.0X
DOMPERIDO SOLAN HIMACHAL CAPSULES 3.0X10.0
NE CAPSULES PRADESH CAPSULE
STRIP
306 NDA/MAL/H AUROLAB SWASTIK AUROVISC- HYPROMELLO 2%W/V AUROLAB.-SIVAGANGAI INDIA OPHTHALMI 1.0X2.0 7/1/2013
DP/0594 PHARMACEUTIC 2ML PFS SE MAIN ROAD, C PRE-FILLED ML PRE-
AL LTD OPHTHALMIC VEERAPANJAN, MADURAI SYRINGES FILLED
SOLUTION 625 020 TAMIL INDIA SYRINGE
USP
307 NDA/MAL/H ARISTO NORVIK ORNOF ORNIDAZOLE 500MG + ARISTO INDIA ORAL SOLID 1.0X10.0X 7/1/2015
DP/0595 PHARMACEUT ENTERPRISES + OFLOXACIN 200MG PHARMACEUTICALS PVT ORDINARY 10.0
ICALS PVT LTD LIMITED LTD---VILLAGE FILM- TABLET
MAKHNUMAJRA P.O COATED BLISTER,1.
BHUD BADDI DISTRICT TABLETS 0X3.0X10.
SOLAN (H.P) 173205 0 TABLET
BLISTER
308 NDA/MAL/H MICRO LABS PHILLIPS ARBITEL-H TELMISARTA 40MG/12.5 MICRO LABS LTD-92, INDIA ORAL SOLID 1.0X3.0X1 7/1/2011
DP/0596 LTD PHARMACEUTIC N/HYDROCHL MG SIPCOT INDUSTRIAL ORDINARY 0.0
ALS (UGANDA) OROTHIAZIDE COMPLEX HOSU R-635126 TABLETS TABLET
LIMITED (T.N) INDIA STRIP
309 NDA/MAL/H INTAS NORVIK LIPICURE- ATORVASTATI 20MG INTAS PHARMACEUTICALS INDIA ORAL SOLID 1.0X10.0 7/1/2003
DP/0598 PHARMACEUT ENTERPRISES 20 N LIMITED(BIOPHARMA ORDINARY TABLET
ICALS LTD LIMITED DIVISION)-CAMP ROAD FILM- BLISTER
SELAQUI-248197, COATED
DEHRADUN TABLETS
(UTTARAKHAND) INDIA
310 NDA/MAL/H MICRO LABS LABOREX GRAMOCEF- CEFIXIME 400MG MICROLABS LIMITED-PLOT INDIA ORAL SOLID 1.0X6.0 7/1/2013
DP/0599 LIMITED UGANDA O-400 NO. 121-124, KIADB, ORDINARY TABLET
LIMITED BOMMASANDRA , -JIGNI TABLETS BLISTER,1.
LINK ROAD, ANEKUL 0X10.0
TALUK,BANGALORE, TABLET
KARNATAKA, INDIA BLISTER
311 NDA/MAL/H DENK PHARM BENLE CONSULT CARVEDI- CARVEDILOL 6.25MG ARTESAN PHARMA GMBH GERMANY ORAL SOLID 1.0X3.0X1 7/1/2015
DP/0600 GMBH&CO.K LIMITED DENK 6.25 & CO. KG - ORDINARY 0.0
G WENDLANDSTRABE TABLETS TABLET
1,29439 BLISTER
LUCHOW,GERMANY
312 NDA/MAL/H MEDLEY MEDVIN GROMIN MULTI- MULTI- MEDLEY INDIA ORAL LIQUID 1.0X100.0 7/1/1999
DP/0603 PHARMACEUT PHARMA SYRUP INGREDIENT INGREDIEN PHARMACEUTICALS LTD- ORDINARY ML
ICALS LTD LIMITED T PLOT NO.18 AND 19, SYRUPS BOTTLE,1.
SURVEY NO.378/8 & 0X200.0
379/2, KEBRA INDUSTRIAL ML
ESTATE, KACHIGAM, BOTTLE
DAMAN-396210 INDIA
313 NDA/MAL/H DAWA SUPER MEDIC TRIMOXOL CO- 480MG DAWA LIMITED -16633- KENYA ORAL SOLID 1.0X1000. 7/1/1997
DP/0604 PHARMACEUT LTD-MBARARA TRIMOXAZOL 00620, RUARAKA, BABA ORDINARY 0 TABLET
ICALS LIMITED E DOGO ROAD, NAIROBI TABLETS CONTAIN
ER
314 NDA/MAL/H DENK PHARM BENLE CONSULT CARVEDI- CARVEDILOL 25MG ARTESAN PHARMA GMBH GERMANY ORAL SOLID 1.0X3.0X1 7/1/2015
DP/0605 GMBH&CO.K LIMITED DENK 25 & CO. KG - ORDINARY 0.0
G WENDLANDSTRABE TABLETS TABLET
1,29439 BLISTER
LUCHOW,GERMANY
315 NDA/MAL/H CIPLA LTD QUALITY LOPINAVIR LOPINAVIR + 200MG + CIPLA LTD -MIDC INDIA ORAL SOLID 1.0X120.0 7/1/2012
DP/0608 CHEMICALS LTD - AND RITONAVIR 50MG PATALGANGA MS 410 220 ORDINARY TABLET
HUMAN RITONAVIR INDIA MFG LIC: 845 FILM- BOTTLE
TABLETS COATED
200MG/50 TABLETS
MG
316 NDA/MAL/H DENK BENLE CONSULT CLOPI- CLOPIDOGREL 75MG ARTESAN PHARMA GMBH GERMANY ORAL SOLID 1.0X3.0X1 7/1/2015
DP/0609 PHARMA LIMITED DENK 75 BESYLATE & CO. KG - ORDINARY 0.0
GMBH & CO WENDLANDSTRABE FILM- TABLET
KG 1,29439 COATED BLISTER
LUCHOW,GERMANY TABLETS
317 NDA/MAL/H ABACUS ABACUS PYLOR KIT LANSOPRAZO 30MG + LINCOLN INDIA ORAL SOLID 1.0X7.0X1 7/1/2014
DP/0610 PARENTERAL PARENTERAL LE DELAYED 250MG + PHARMACEUTICALS LTD .- ORDINARY .0X6.0
DRUGS DRUGS LIMITED RELEASE + 500MG 10,12,13 TRIMUL ESTATE, ENTERIC- TABLET
LIMITED CLARITHROM NEAR KHATRAJ CHOKADI, COATED BLISTER
YCIN+ P.O. KHATRAJ-382721 TA: TABLETS (BLISTER
TINIDAZOLE KALOL, DIST. CONTAINS
GANDHINAGAR, GUJARAT 2
CAPSULES
AND 4
TABLETS)
318 NDA/MAL/H GALPHAR AIVEEN (U) GALCIPRO CIPROFLOXAC 500MG GALPHA LABORATORIES INDIA ORAL SOLID 1.0X10.0X 7/1/2015
DP/0611 LABORATORIE LIMITED 500 IN LIMITED-VILLAGE – ORDINARY 10.0
S LTD HYDROCHLOR THANA BADDI, TEHSIL FILM- TABLET
IDE BADDI COATED BLISTER
SOLAN HIMACHAL TABLETS
PRADESH-173 205 INDIA
319 NDA/MAL/H GLAXOSMITH UNITED CLAVULIN AMOXICILLIN 126 MG/ 5 SMITHKLINE BEECHAM UNITED ORAL LIQUID 1.0X70.0 7/1/1998
DP/0614 KLINE HEALTHCARE + ML + 31.25 PHARMACEUTICALS,- KINGDOM ORDINARY ML
PHARMACEUT DISTRIBUTORS CLAVULANIC MG/ 5 ML CLARENDON ROAD, DRY BOTTLE,1.
ICAL KENYA LTD ACID WORTHING, WEST SUSPENSION 0X100.0
LTD SUSSEX, BN148QH S/SYRUPS/D ML
ROPS BOTTLE
320 NDA/MAL/H HETERO LABS AIVEEN (U) VALSAR 80 VALSARTAN 80MG HETERO LABS LTD. UNIT INDIA ORAL SOLID 1.0X3.0X1 7/1/2015
DP/0615 LTD LIMITED (V)-S.N0.439, 440, 441& ORDINARY 0.0
458, APIIC, PHARMA SEZ, FILM- TABLET
509301 INDIA
321 NDA/MAL/H ABACUS ABACUS SILVEX SILVER 1%W/W + LINCOLN INDIA TOPICAL 1.0X15.0 7/1/2014
DP/0617 PARENTERAL PARENTERAL SULFADIAZIN 0.2%W/W PHARMACEUTICALS LTD .- EXTERNAL G TUBE
DRUGS DRUGS LIMITED E+ 10,12,13 TRIMUL ESTATE, CREAMS
LIMITED CHLORHEXIDI NEAR KHATRAJ CHOKADI,
NE P.O. KHATRAJ-382721 TA:
KALOL, DIST.
322 NDA/MAL/H HETERO LABS AIVEEN (U) VALSAR 160 VALSARTAN 160MG HETERO LABS LTD. UNIT INDIA ORAL SOLID 1.0X3.0X1 7/1/2015
DP/0618 LTD LIMITED (V)-439, 440, 441& 458, ORDINARY 0.0
509301 INDIA.
323 NDA/MAL/H ABACUS ABACUS D10 GLUCOSE 10%W/V ABACUS PARENTERAL UGANDA PARENTERAL 1.0X500.0 7/1/2013
DP/0619 PARENTERAL PARENTERAL DRUGS LTD-PLOT NO. 114, ORDINARY ML
DRUGS DRUGS LIMITED BLOCK 191, GWAGAMYA, INFUSION BOTTLE,1.
LIMITED KINGA, KAPEKE, VIALS/BOTTL 0X250.0
MUKONO ES ML
BOTTLE
324 NDA/MAL/H HETERO LABS AIVEEN (U) ALZER DONEPEZIL 10MG HETERO LABS LTD. UNIT INDIA ORAL SOLID 1.0X10.0X 7/1/2015
DP/0621 LTD LIMITED HYDROCHLOR (V)-439, 440, 441& 458, ORDINARY 10.0
IDE APIIC, PHARMA SEZ, FILM- TABLET
509301 INDIA.
325 NDA/MAL/H ABACUS ABACUS GELCID MAGNESIUM 50%W/V LINCOLN INDIA PARENTERAL 1.0X10.0X 7/1/2015
DP/0623 PARENTERAL PARENTERAL SULPHATE PHARMACEUTICALS LTD-- ORDINARY 5.0X10.0
DRUGS DRUGS LIMITED 11 TRIMUL ESTATE, NEAR AMPOULES ML
LIMITED KHATRAJ CHOKADI, P.O. AMPOULE
KHATRAJ-382721 TA: ,1.0X10.0X
KALOL, DIST. 5.0X5.0
GANDHINAGAR, GUJARAT ML
AMPOULE
IN
BLISTER
PACK,1.0X
5.0 ML
326 NDA/MAL/H SANOFI LABOREX VERORAB RABIES 1 DOSE SANOFI PASTEUR-1541 FRANCE PARENTERAL 1.0X1.0 7/1/1997
DP/0625 PASTEUR UGANDA VACCINE AVENUE MARCEL ORDINARY DOSE
LIMITED MERIEUX, 69280 MARCY, VIALS VIAL,1.0X
LETOILE 5.0X1.0
DOSE VIAL
+
1.0X5.0X0
.5ML
GLASS
AMPOULE
S OF 0.9%
SODIUM
327 NDA/MAL/H KPI KAMPALA CARDIPAC- AMLODIPINE 10MG KPI INDUSTRIES (1996) UGANDA ORAL SOLID 1.0X1.0X1 7/1/2015
DP/0626 INDUSTRIES(1 PHARMACEUTIC 10 BESILATE LTD-PLOT NO.M444B ORDINARY 0.0X10.0
996) LTED AL INDUSTRIES STRETCHER RD, NTINDA, TABLETS TABLET
1996 LIMITED KAMPALA BLISTER
328 NDA/MAL/H KAMPALA KAMPALA AMOXIKID AMOXICILLIN 125MG KAMPALA UGANDA ORAL SOLID 1.0X3.0X1 7/1/2015
DP/0627 PHARMACEUT PHARMACEUTIC TRIHYDRATE PHARMACEUTICAL ORDINARY 0.0
ICAL AL INDUSTRIES INDUSTRIES (1996) LTD- TABLETS TABLET
INDUSTRIES 1996 LIMITED PLOT M 444B STRETCHER STRIP,1.0X
(1996) LTD ROAD NTINDA 2.0X10.0
TABLET
BLISTER,1.
0X10.0X10
.0 TABLET
BLISTER
329 NDA/MAL/H CADILA ABACUS NEO DESLORATADI 5MG CADILA HEALTHCARE LTD- INDIA ORAL SOLID 1.0X1.0X1 7/1/2011
DP/0630 HEALTH CARE PHARMA LORIDIN NE KUNDAIM INDUSTRIAL ORDINARY 0.0
LIMITED (AFRICA) ESTATE, PLOT NO.203- TABLETS TABLET
LIMITED 213, KUNDAIM GOA, BLISTER,1.
403115, INDIA 0X10.0X10
.0 TABLET
BLISTER,1.
0X3.0X10.
0 TABLET
BLISTER
330 NDA/MAL/H ABACUS ABACUS CIPROCIN CIPROFLOXAC 0.3%W/V ABACUS PARENTERAL UGANDA OPHTHALMI 1.0X10.0 7/1/2013
DP/0633 PARENTERAL PARENTERAL IN DRUGS LTD-PLOT NO. 114, C DROPS ML VIAL
DRUGS DRUGS LIMITED BLOCK 191, GWAGAMYA,
LIMITED KINGA, KAPEKE,
MUKONO
331 NDA/MAL/H MEDLEY MEDVIN TRISOLIV ANDROGRAP 50MCG+50 MEDLEY INDIA ORAL LIQUID 1.0X200.0 7/1/2014
DP/0634 PHARMACEUT PHARMA HOLIDES/TRIC MG/ML PHARMACEUTICALS LTD- ORDINARY ML
ICALS LIMITED HOLINE PLOT NO.18 AND 19, SYRUPS BOTTLE
CITRATE SURVEY NO.378/8 &
379/2, KEBRA INDUSTRIAL
ESTATE, KACHIGAM,
DAMAN-396210 INDIA
332 NDA/MAL/H GITTOES GITTOES AGO-AMIN AMINOPHYLLI 100MG AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1.0X10.0X 7/1/2009
DP/0635 PHARMACEUT PHARMACEUTIC NE NO.33,SECTOR ORDINARY 10.0
E INDIA TABLET
CONTAIN
ER,1.0X10
0.0X10.0
TABLET
BLISTER
333 NDA/MAL/H MYLAN KIMSY MEDS REVOKE-1.5 LEVONORGES 1.5MG MYLAN LABORATORIES INDIA ORAL SOLID 1.0X1.0 7/1/2014
PLOT NO.20 & 21,
PHARMEZ, SARKHEJ-
BAVLA NATIONAL
334 NDA/MAL/H NABIQASIM JEET ZUDICORT FUSIDIC ACID 20MG + NABIQASIM INDUSTRIES PAKISTAN TOPICAL 1.0X15.0 7/1/2014
DP/0637 INDUSTRIES PHARMACEUTIC + 1MG/G (PVT) LIMITED-17/24, EXTERNAL G TUBE
(PVT) LIMITED ALS LIMITED BETAMETHAS KORANGI INDUSTRIAL CREAMS
ONE AREA, KARACHI, PAKISTAN
VALERATE
335 NDA/MAL/H PHARMACIE ABACUS ABLOL-5 TIMOLOL 0.5% W/V ABACUS PARENTERAL UGANDA OPHTHALMI 1.0X10.0 7/1/2013
DP/0638 BETHEL PARENTERAL EYE DROPS MALEATE DRUGS LTD-PLOT NO. 114, C DROPS ML VIAL
DRUGS LIMITED BLOCK 191, GWAGAMYA,
KINGA, KAPEKE,
MUKONO
336 NDA/MAL/H SHOSAAN RENE RHEUMATI MULTI- MULTI- NEM LABORATORIES PVT INDIA TOPICAL 1.0X15.0 7/1/1997
DP/0639 ASIC PACIFIC PHARMACY LTD C CREAM INGREDIENT INGREDIEN LTD-133 VASAI RD(E) 401 EXTERNAL G TUBE
T 162 SB MARG. LOWER CREAMS
PAREL MUMBAI
337 NDA/MAL/H ABACUS ABACUS GYNAZOLE CLOTRIMAZO 2%W/W LINCOLN INDIA TOPICAL 1.0X30.0 7/1/2014
DP/0641 PARENTERAL PARENTERAL LE PHARMACEUTICALS LTD .- EXTERNAL G TUBE
DRUGS DRUGS LIMITED 10,12,13 TRIMUL ESTATE, CREAMS
LIMITED NEAR KHATRAJ CHOKADI,
KALOL, DIST.
338 NDA/MAL/H NAARI AG ECHO MISOPRO MISOPROSTO 200MCG NAARI PHARMA PRIVATE ARGENTINA ORAL SOLID 1.0X4.0 7/1/2013
DP/0643 PHARMACY (U) L LIMITED-PLOT NO. 14-16, ORDINARY TABLET
LIMITED 55-57, SECTOR-5, IIE, TABLETS BLISTER,1.
PANT NAGAR RUDRAPUR- 0X3.0
263153 DIST-U.S. NAGAR TABLET
UTTARAKHAND BLISTER,2
5.0X1.0X4
.0 TABLET
BLISTER
339 NDA/MAL/H NVS KENYA SURGIPHARM GALVUS VILDAGLIPTIN 50MG NOVARTIS PHARMA STEIN SWITZERLAN ORAL SOLID 1.0X4.0X1 7/1/2014
DP/0652 LTD (U) LIMITED AG- D ORDINARY 4.0
SCHAFFHARVSERTRASSE TABLETS TABLET
CH-4332 STEIN BLISTER
SWITZERLAND. NOVARTIS
BARBERA -SPAIN
340 NDA/MAL/H HETERO LABS AIVEEN (U) IRBIS 150 IRBESARTAN 150MG HETERO LABS LTD (UNIT- INDIA ORAL SOLID 1.0X10.0X 7/1/2013
DP/0665 LTD LIMITED V)-SY.NO.438,439,440 & ORDINARY 1.0X10.0
458 APIIC FORMULATION TABLETS TABLET
SEZ, POLEPALLY (V), BLISTER,1.
JEDCHERLA (M) 0X3.0X10.
MAHABOOBNAGAR 0 TABLET
PRADESH - INDIA
341 NDA/MAL/H HETERO LABS AIVEEN (U) IRBIS-H 300 IRBESARTAN 300MG HETERO LABS LTD (UNIT- INDIA ORAL SOLID 1.0X10.0X 7/1/2013
DP/0666 LTD LIMITED V)-SY.NO.438,439,440 & ORDINARY 1.0X10.0
SEZ, POLEPALLY (V), BLISTER
JEDCHERLA (M)
MAHABOOBNAGAR
DISTRICT, ANDHRA
PRADESH - INDIA
342 NDA/MAL/H KOTRA ABACUS AXEL MICONAZOLE 2%W/W KOTRA PHARMA (M) SDN. MALAYSIA TOPICAL 1.0X5.0 G 7/1/2013
DP/0667 PHARMA (M) PHARMA MICONAZO NITRATE BHD-1 JALAN TTC 12, EXTERNAL TUBE,1.0X
SDN,BHD (AFRICA) LE CHENG INDUSTRIAL CREAMS 15.0 G
LIMITED ESTATE, 75250 MELAKA TUBE
MALYSIA
343 NDA/MAL/H CADILA ESCORTS TELI 40 TELMISARTA 40MG CADILA INDIA ORAL SOLID 1.0X3.0X1 7/1/2013
DP/0668 PHARMACEUT PHARMACEUTIC N PHARMACEUTICALS ORDINARY 0.0
ICALS LIMITED ALS LIMITED LIMITED-1389, TRASAD TABLETS TABLET
ROAD, DHOLKA- 382225, BLISTER
DIST: AHMEDAD, GUJARAT
STATE, INDIA
344 NDA/MAL/H KOTRA ABACUS AXEL MICONAZOLE 2% W/W + KOTRA PHARMA SDN BDN- MALAYSIA TOPICAL 1.0X5.0 G 7/1/2013
DP/0669 PHARMA (M) PHARMA FUNGICORT NITRATE + 1% W/W 1, 2, &3, JALANTTC12 EXTERNAL TUBE,1.0X
SDN,BHD (AFRICA) CREAM HYDROCORTI CHENG INDUSTRIAL CREAMS 15.0 G
LIMITED SONE ESTATE, 75250, MELAKA, TUBE
MALAYSIA
345 NDA/MAL/H GITTOES GITTOES FLUNAZ- FLUCONAZOL 200MG AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1.0X4.0 7/1/2014
DP/0670 PHARMACEUT PHARMACEUTIC 200 E NO. 33, SECTOR II, VASAI, ORDINARY CAPSULE
ICALS LIMITED ALS LIMITED TALUKA INDL. CAPSULES BLISTER,1.
0X5.0X4.0
CAPSULE
BLISTER
346 NDA/MAL/H KOTRA ABACUS AXCEL LIDOCAINE 2%W/W KOTRA PHARMA (M) SDN. MALAYSIA TOPICAL 1.0X20.0 7/1/2014
DP/0671 PHARMA (M) PHARMA LIGNOCAIN BHD-1 JALAN TTC 12, EXTERNAL G TUBE
SDN BHD (AFRICA) E CHENG INDUSTRIAL GELS AND
LIMITED ESTATE, 75250 MELAKA SOLS
MALYSIA
347 NDA/MAL/H GITTOES GITTOES AGONOR NORFLOXACI 400MG AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1.0X10.0X 7/1/2013
DP/0672 PHARMACEUT PHARMACEUTIC TABLETS N NO.33,SECTOR ORDINARY 10.0
ICALS LIMITED ALS LIMITED II,VASAI,TALUKA INDL CO- FILM- TABLET
OP ESTATE LTD,GAURAI COATED BLISTER,1.
PADA,VASAI(E)DIST.THAN TABLETS 0X100.0X1
E INDIA 0.0
TABLET
BLISTER
348 NDA/MAL/H CADILA ESCORTS ONSETT 8 ONDANSETR 8MG CADILA INDIA ORAL SOLID 1.0X10.0X 7/1/2013
DP/0673 PHARMACEUT PHARMACEUTIC ON PHARMACEUTICALS ORDINARY 10.0
STATE, INDIA
349 NDA/MAL/H GITTOES GITTOES AGODAPS- DAPSONE 100MG AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1.0X10.0X 7/1/2013
DP/0674 PHARMACEUT PHARMACEUTIC 100 NO.33,SECTOR ORDINARY 10.0
E INDIA TABLET
CONTAIN
ER,1.0X10
0.0X10.0
TABLET
BLISTER
350 NDA/MAL/H KOTRA ABACUS AXCEL METRONIDAZ 400MG KOTRA PHARMA-BHD MALAYSIA ORAL SOLID 1.0X10.0X 7/1/2015
DP/0675 PHARMA (M) PHARMA METRONID OLE 1, JALAN TTC 12, CHENG ORDINARY 10.0
SDN,BHD (AFRICA) AZOLE 400 INDUSTRIAL ESTATE, TABLETS TABLET
LIMITED 75250 MELAKA, MALAYSIA BLISTER
351 NDA/MAL/H CADILA ESCORTS ONSETT 4 ONDANSETR 4MG CADILA INDIA ORAL SOLID 1.0X10.0X 7/1/2013
DP/0676 PHARMACEUT PHARMACEUTIC ON PHARMACEUTICALS ORDINARY 10.0
STATE, INDIA
352 NDA/MAL/H GITTOES GITTOES DOPAMET METHYLDOPA 250MG AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1.0X10.0X 7/1/2014
ICALS LIMITED ALS LIMITED TALUKA INDL. FILM- TABLET
COATED BLISTER
TABLETS
353 NDA/MAL/H KOTRA ABACUS AXCEL HYDROCORTI 1%W/W KOTRA PHARMA (M) SDN. MALAYSIA TOPICAL 1.0X15.0 7/1/2014
DP/0678 PHARMA (M) PHARMA HYDROCOR SONE BHD-1 JALAN TTC 12, EXTERNAL G
SDN BHD (AFRICA) TISONE CHENG INDUSTRIAL CREAMS TUBE,1.0X
LIMITED CREAM ESTATE, 75250 MELAKA 5.0 G
MALYSIA TUBE
354 NDA/MAL/H GITTOES GITTOES MEFENA- MEFENAMIC 250MG AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1.0X10.0X 7/1/2013
DP/0679 PHARMACEUT PHARMACEUTIC 250 ACID NO.33,SECTOR ORDINARY 10.0
ICALS LIMITED ALS LIMITED CAPSULES II,VASAI,TALUKA INDL CO- OTHER CAPSULE
OP ESTATE LTD,GAURAI CAPSULES BLISTER,1.
E INDIA 0.0
CAPSULE
BLISTER
355 NDA/MAL/H GENNOVA HARLEYS ELAXIM 40 TENECTEPLAS 40MG/VIA GENNOVA INDIA PARENTERAL 1.0X40.0 7/1/2013
DP/0681 BIOPHARMAC UGANDA E L BIOPHARMACEUTICALS ORDINARY MG VIAL ,
EUTICALS LTD LIMITED (RECOMBINA LIMITED-BLOCK 1, PLOT DRY VIALS 1*8 ML
NT TISSUE NO. P-1 AND P-2, ITBT VIAL OF
PLASMINOGE PARK, PHASE II, MIDC, WFI
N HINJAWADI, PUNE -
ACTIVATOR) 411057
356 NDA/MAL/H TROGE ECHO TRO- CEFTRIAXONE 1G REYOUNG CHINA PARENTERAL 1.0X1.0 G 7/1/2014
DP/0684 MEDICAL PHARMACY (U) CEFTRIAX PHARMACEUTICAL CO. ORDINARY VIAL +
GMBH LIMITED 1G LTD-NO. 6 ERLANGSHAN DRY VIALS 1X5ML
ROAD, YIYUAN, WFI
SHANDONG 256100 AMPOULE
357 NDA/MAL/H FERRER LABOREX SOMAZINA CITICOLINE 1000MG FERRER INTERNATIONAL, SPAIN PARENTERAL 1.0X5.0X4 7/1/2015
DP/0685 INTERNACION UGANDA S.A.-C/JOAN BUSCALLA, 1- RETARD I M .0 ML
AL S.A LIMITED 9.08173 SANT CUGAT DEL AMPOULES AMPOULE
VALLES, BARCELONA
358 NDA/MAL/H FERRER LABOREX SOMAZINA CITICOLINE 1000MG FERRER INTERNATIONAL, SPAIN ORAL LIQUID 1.0X6.0X1 7/1/2015
DP/0687 INTERNACION UGANDA S.A.-C/JOAN BUSCALLA, 1- ORDINARY 0.0 ML
AL S.A LIMITED 9.08173 SANT CUGAT DEL LIQUIDS SACHET
VALLES, BARCELONA
359 NDA/MAL/H GITTOES GITTOES HBB HYOSCINE 10MG AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1.0X10.0X 7/1/2014
DP/0688 PHARMACEUT PHARMACEUTIC BUTYLBROMI NO.33,SECTOR ORDINARY 10.0
ICALS LIMITED ALS LIMITED DE II,VASAI,TALUKA INDL CO- COATED TABLET
OP ESTATE LTD,GAURAI TABLETS BLISTER
E INDIA
360 NDA/MAL/H GITTOES GITTOES AGONAL NALIDIXIC 500MG AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1.0X10.0X 7/1/2013
DP/0689 PHARMACEUT PHARMACEUTIC ACID NO.33,SECTOR ORDINARY 10.0
OP ESTATE LTD,GAURAI BLISTER
E INDIA
361 NDA/MAL/H MACK SHURIK LTD HEALTHEAS BECLOMETHA 0.025%W/ TORQUE INDIA TOPICAL 1.0X30.0 7/1/2014
DP/0690 BROWN E CREAM SONE W+ PHARMACEUTICALS LTD- EXTERNAL G TUBE
PHARMECEUT DIPROPRION 0.1%W/W ISSAPUR P.O DAPPAR CREAMS
ICALS PVT LTD ATE + + 140506
PHENYLEPHRI 2.5%W/W
NE HCL + +
LIGNOCAINE 0.1%W/W
HCL +
CHLOROCRES
OL
362 NDA/MAL/H MICRO LABS PHILLIPS OLMAT-20 OLMESARTAN 20 MG MICRO LABS LTD--NO 92, INDIA ORAL SOLID 1.0X3.0X1 7/1/2013
DP/0691 LTD PHARMACEUTIC MEDOXOMIL SIPCOT, HOSUR-635 126,, ORDINARY 0.0
ALS (UGANDA) TAMIL NADU, INDIA FILM- TABLET
TABLETS
363 NDA/MAL/H DAWA SUPER MEDIC DAWACLOX CLOXACILLIN 250MG DAWA LIMITED -BABA KENYA ORAL SOLID 1.0X10.0X 7/1/2015
DP/0692 LIMITED LTD -250 SODIUM DOGO RWARAKA ORDINARY 10.0
CAPSULES CAPSULE
BLISTER,1.
0X1000.0
CAPSULE
CONTAIN
ER
364 NDA/MAL/H DAWA SUPER MEDIC MOXACIL - AMOXYCILLIN 250MG DAWA PHARMACEUTICALS KENYA ORAL SOLID 1.0X10.0X 7/1/2014
DP/0693 LIMITED LTD 250 TRIHYDRATE LIMITED-PLOT 7879, BABA ORDINARY 10.0
DOGO ROAD RUARAKA CAPSULES CAPSULE
BLISTER,1.
0X1000.0
CAPSULE
CONTAIN
ER
365 NDA/MAL/H GITTOES GITTOES DT ZINC-20 ZINC 20MG AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1.0X10.0 7/1/2013
DP/0694 PHARMACEUT PHARMACEUTIC TABLETS SULPHATE NO. 33, SECTOR II, VASAI, ORDINARY TABLET
ICALS LIMITED ALS LIMITED TALUKA INDL. SOLUBLE BLISTER,1.
TABLETS 0X10.0X10
.0 TABLET
CARTON
366 NDA/MAL/H ELYS VELVET WHITFIELD' BENZOIC 6%W/W + ELYS CHEMICAL KENYA TOPICAL 1.0X20.0 7/1/2003
DP/0698 CHEMICAL PHARMA S ACID+SALICYL 3%W/W INDUSTRIES LTD-ROAD 'B' EXTERNAL G TUBE
INDUSTRIES LIMITED OINTMENT IC CID OFF ENTERPRISE ROAD, OINTMENTS
LTD INDUSTRIAL AREA
NAIROBI
367 NDA/MAL/H CADILA ABACUS VAXIRAB N INACTIVATED >2.5 I.U CADILA HEALTHCARE LTD-- INDIA PARENTERAL 1.0X1.0 7/1/2015
DP/0700 HEALTHCARE PHARMA RABIES -SARKHEJ-PLOT ORDINARY ML VIAL +
LTD (AFRICA) VIRUS(PITMA 417,419,420, SARKHEJ- VIALS 1ML
LIMITED N MOORE BAVLA NH AMPOULE
STRAIN) NO.8A,VILLAGE: MORAIYA OF WFI(1
TAL: SANAND DISTRICT DOSE
AHMEDABAD 382210 VIAL)
368 NDA/MAL/H ABACUS ABACUS SEPTOCIN STREPTOMYC 1GM REYOUNG CHINA PARENTERAL 1.0X50.0X 7/1/2014
DP/0702 PHARMA (A) PHARMA IN SULPHATE PHARMACEUTICAL CO. ORDINARY 1.0 G VIAL
LTD. (AFRICA) LTD-NO. 6 ERLANGSHAN DRY VIALS
LIMITED ROAD, YIYUAN,
SHANDONG 256100
369 NDA/MAL/H GOOD DAY PLANET DICLODAY DICLOFENAC 11.6MG + KREMOINT PHARMA PVT INDIA TOPICAL 1.0X30.0 7/1/2013
DP/0703 PHARMACY PHARMACEUTIC GEL DIETHYLAMIN 30MG + LTD---B-8 ADDITIONAL EXTERNAL G TUBE
LIMITED ALS UGANDA E+ LINSEED 100MG + AMBERNATH MIDC OPP. GELS AND
LTD OIL+ METHYL 50MG ANAND NAGAR POLICE SOLS
SALICYLATE CHECK POST AMBERNATH
+MENTHOL (E) DIST THANE 421 506
370 NDA/MAL/H HETERO LABS AIVEEN (U) M-FLOX MOXIFLOXACI 400MG HETERO LABS LTD (UNIT- INDIA ORAL SOLID 1.0X10.0X 7/1/2013
DP/0704 LTD UNIT IX LIMITED N V)-SY.NO.438,439,440 & ORDINARY 10.0
HYDROCHLOR 458 APIIC FORMULATION FILM- TABLET
IDE SEZ, POLEPALLY (V), COATED BLISTER,1
JEDCHERLA (M) TABLETS 0.0X1.0X5
MAHABOOBNAGAR .0 TABLET
PRADESH - INDIA HETERO
LABS LTD-UNIT II & III
BADDI THE NALAGARH
DIST SOLAN H.P
371 NDA/MAL/H LINCOLN METRO ACICLOVIR ACICLOVIR 5%W/W LINCOLN INDIA TOPICAL 1.0X10.0 7/1/2011
DP/0705 PHARMACEUT PHARMACEUTIC PHARMACEUTICAL EXTERNAL G TUBE
ICALS LTD ALS LIMITED LIMITED-TRIMAL ESTATE CREAMS
KHATRAJ KOLOL,GUJARAT
INDIA
372 NDA/MAL/H INTAS NORVIK ROVAS 5 ROSUVASTATI 5MG INTAS PHARMACEUTICALS INDIA ORAL SOLID 1.0X3.0X1 7/1/2013
DP/0706 PHARMACEUT ENTERPRISES N LIMITED -CAMP ROAD, ORDINARY 0.0
ICALS LIMITED LIMITED SELAQUI- FILM- TABLET
248197,DEHRADUN COATED BLISTER
UTTARAKHAND, INDIA TABLETS
373 NDA/MAL/H HETERO LABS AIVEEN (U) PENVIR 500 FAMCICLOVIR 500MG HETERO LABS LTD(UNIT INDIA ORAL SOLID 1.0X10.0X 7/1/2013
DP/0707 LTD LIMITED V).-JADCHERLA ORDINARY 10.0
(M),MAHABOOBNAGAR FILM- TABLET
DIST, ANDHRA COATED BLISTER
PRADESH,INDIA TABLETS
DP/0710 PHARMACEUT ENTERPRISES N LIMITED -CAMP ROAD, ORDINARY 0.0
ICALS LIMITED LIMITED SELAQUI- FILM- TABLET
248197,DEHRADUN COATED BLISTER
UTTARAKHAND, INDIA TABLETS
375 NDA/MAL/H GLAXOSMITH UNITED ZENTEL ALBENDAZOL 100MG/5 FARMACLAIR -440 FRANCE ORAL LIQUID 1.0X20.0 7/1/1997
DP/0712 KLINE HEALTHCARE E ML AVENUE DU GENERAL DE ORDINARY ML
PHARMACEUT DISTRIBUTORS GAULLE 14200 SUSPENSION BOTTLE
ICAL KENYA LTD HEROUVILLE SAINT CLAIR S
LTD FRANCE
376 NDA/MAL/H DENK PARMA BENLE CONSULT PANTO- PANTOPRAZO 20MG ADVANCE PHARMA GERMANY ORAL SOLID 1.0X2.0X1 7/1/2015
DP/0713 GMBH & CO. LIMITED DENK 20 LE SODIUM GMBH..-WALLENRODER ORDINARY 4.0
KG SESQUIHYDR STR.12-14, 13435 BERLIN ENTERIC- TABLET
ATE COATED BLISTER
TABLETS
377 NDA/MAL/H DENK PARMA BENLE CONSULT PANTO- PANTOPRAZO 40MG ADVANCE PHARMA GERMANY ORAL SOLID 1.0X2.0X1 7/1/2015
DP/0715 GMBH & CO. LIMITED DENK 40 LE SODIUM GMBH..-WALLENRODER ORDINARY 4.0
KG SESQUIHYDR STR.12-14, 13435 BERLIN ENTERIC- TABLET
ATE COATED BLISTER
TABLETS
378 NDA/MAL/H LINCOLN METRO GLYMET-1 GLIMEPIRIDE 1MG + LINCOLN INDIA ORAL SOLID 1.0X10.0X 7/1/2014
DP/0716 PHARMACEUT PHARMACEUTIC +METFORMIN 500MG PHARMACEUTICALS L.T.D- ORDINARY 10.0
ICALS LTD ALS LIMITED HYDROCHLOR TRIMUL ESTATE KHATRAJ TABLETS TABLET
IDE 382721 GHANDINAGAR BLISTER,1.
GUJARAT 0X3.0X10.
0 TABLET
BLISTER
379 NDA/MAL/H LINCOLN METRO GLYMET-2 GLIMEPIRIDE 2MG + LINCOLN INDIA ORAL SOLID 1.0X3.0X1 7/1/2014
DP/0718 PHARMACEUT PHARMACEUTIC +METFORMIN 500MG PHARMACEUTICALS L.T.D- ORDINARY 0.0
ICALS LTD ALS LIMITED HYDROCHLOR TRIMUL ESTATE KHATRAJ TABLETS TABLET
IDE 382721 GHANDINAGAR BLISTER,1.
GUJARAT 0X5.0X10.
0 TABLET
BLISTER
380 NDA/MAL/H WOCKHARDT STAR WEPOX RECOMBINAN 4000 I.U WOCKHARDT LIMITED -- INDIA PARENTERAL 1.0X0.4 7/1/2011
DP/0719 LTD PHARMACEUTIC 4000 T HUMAN WOCKHARDT BIOTECH ORDINARY ML PRE-
ALS LTD ERYTHROPOI PARK, H14/2, M.I.D.C, PRE-FILLED FILLED
ETIN WALUJ, AURANGABAD SYRINGES SYRINGE
431136 MAHARASHTRA
INDIA
381 NDA/MAL/H STEDMAN VEERAM JUSDEE 400 COLECALCIFE 400 I.U/ML STEDMAN INDIA ORAL LIQUID 1.0X15.0 7/1/2013
DP/0720 PHARMACEUT HEALTHCARE DROPS ROL PHARMACEUTICALS PVT ORDINARY ML
ICALS PVT. (U) LIMITED LIMITED-NO. C-4, SIDCO DROPS BOTTLE
LTD PHARMACEUTICAL
COMPLEX, ALATHUR,
THIRUPORUR,
382 NDA/MAL/H MISSION METRO ARH-A ARTEMETHER 80MG/ML LINCOLN PARENTERAL LTD- INDIA PARENTERAL 1.0X2.0X3 7/1/2014
DP/0721 PHARMA PHARMACEUTIC 11, TRIMUL ESTATE, NEAR ORDINARY I .0X1.0 ML
ALS LIMITED KHATRAJ CHOLADI, P.O. M AMPOULE
KHATRAJ-382721 TA: AMPOULES ,1.0X1.0X6
KALOL, DIST. .0 ML
GANDHINAGAR, GUJARAT AMPOULE
383 NDA/MAL/H FDC LTD AIVEEN (U) IOTIM 0.5% TIMOLOL 0.5% W/V FDC LIMITED -B-8, INDIA OPHTHALMI 1.0X5.0 7/1/2014
DP/0722 LIMITED MALEATE M.I.D.C., INDUSTRIAL C DROPS ML
AREA, WALUJ – BOTTLE
AURANGABAD- 431 136
MAHARASHTRA, INDIA.
384 NDA/MAL/H TROIKAA ABACUS T DOL TRAMADOL 50MG TROIKAA INDIA ORAL SOLID 1.0X10.0X 7/1/2014
DP/0726 PHARMACEUT PHARMA RAPID HYDROCHLOR PHARMACEUTICALS LTD- ORDINARY 10.0
ICALS LIMITED (AFRICA) IDE SARA INDUSTRIAL ESTATE ORALLY TABLET
LIMITED SELAQUI DEHRADUN DISINTEGRA STRIP
248197 UTTARAKHAND TING
TABLETS
385 NDA/MAL/H MACK SHURIK LTD STOMACH BISMUTH 140MG+9 TORQUE INDIA ORAL LIQUID 1.0X225.0 7/1/2013
DP/0727 BROWN FIT SYRUP AMMONIUM MG+0.15M PHARMACEUTICALS LTD- ORDINARY ML
PHARMECEUT CITRATE+BEL G+0.2/5ML ISSAPUR P.O DAPPAR LIQUIDS BOTTLE
ICALS PVT LTD LADONA DRY 140506
EXTRACT+TH
YMOL+MENT
HOL
386 NDA/MAL/H IPCA MEDVIN ARTESUNA ARTESUNATE 25MG+67. IPCA LABORATORIES INDIA ORAL SOLID 1.0X1.0X3 7/1/2013
DP/0728 LABORATOIES PHARMA TE AND +AMODIAQUI 5MG LIMITED -SEJAVTA ORDINARY .0 TABLET
LTD LIMITED AMODIAQU NE VILLAGE, DIST. RATLAM TABLETS BLISTER
INE 25/67.5 (M.P) 457002
INDIA.
387 NDA/MAL/H IPCA MEDVIN ARTESUNA ARTESUNATE 50/135MG IPCA LABORATORIES INDIA ORAL SOLID 1.0X1.0X3 7/1/2013
DP/0731 LABORATORIE PHARMA TE AND + LIMITED -SEJAVTA ORDINARY .0 TABLET
S LTD LIMITED AMODIAQU AMODIAQUIN VILLAGE, DIST. RATLAM TABLETS BLISTER
INE 50/135 E (M.P) 457002
INDIA.
388 NDA/MAL/H ANHIU MAISHA VOLTAMED- DICLOFENAC 100 MG MEDICO REMEDIES PVT INDIA ORAL SOLID 1.0X10.0X 7/1/2015
DP/0732 MEDICAL 100 LIMITED-8 & 9 DEWAN & ORDINARY 10.0
SUPPLIES SONS, UDYOG NAGAR ENTERIC- TABLET
LIMITED PALGAR, DISTRICT THANE COATED BLISTER
MAHARASHTRA, INDIA TABLETS
389 NDA/MAL/H CADILA ABACUS ZYNAC ACECLOFENA 100MG CADILA HEALTH CARE LTD- INDIA ORAL SOLID 1.0X10.0X 7/1/2013
DP/0733 HEALTH CARE PHARMA C KUNDAIM INDUSTRIAL ORDINARY 10.0
LIMITED (AFRICA) ESTATE, PLOT NO. 203- FILM- TABLET
LIMITED 213, KUNDAIM,GOA-403 COATED BLISTER
115, INDIA TABLETS
390 NDA/MAL/H SANOFI SURGIPHARM TAXOTERE DOCETAXEL 80MG/4ML SANOFI-AVENTIS GERMANY PARENTERAL 1.0X4.0 7/1/2014
DP/0737 AVENTIS (U) LIMITED 80MG TRIHYDRATE DEUTSCHLAND GMBH - ORDINARY ML VIAL
INDUSTRIEPARK HOECHST, INFUSION
BRUNINGSTRASSEN, VIALS/BOTTL
BUILDING ES
H650 65926 FRANKFURT
AM MAIN, GERMANY
391 NDA/MAL/H SANOFI SURGIPHARM TAXOTERE DOCETAXEL 20MG/ML SANOFI-AVENTIS GERMANY PARENTERAL 1.0X1.0 7/1/2014
DP/0739 AVENTIS (U) LIMITED 20MG TRIHYDRATE DEUTSCHLAND GMBH- ORDINARY ML VIAL
INDUSTRIEPARK INFUSION
HOESCHST,BRUNINGSTRA VIALS/BOTTL
SSEN BUIDING,H65065926, ES
FRANKFURT AM MAIN
392 NDA/MAL/H MEDOCHEMIE BOOTS BROT METFORMIN 500MG MEDOCHEMIE LTD- CYPRUS ORAL SOLID 1.0X10.0X 7/1/2013
DP/0742 LTD PHARMACEUTIC HYDROCHLOR CENTRAL FACTORY A-1-10 ORDINARY 10.0
ALS LIMITED IDE CONSTANTINOUPOLEUS TABLETS TABLET
STREET 3011 LIMASSOL BLISTER
393 NDA/MAL/H CADILA ESCORTS TELI 80 TELMISARTA 80MG B. BRAUN MELSUNGEN - INDIA ORAL SOLID 1.0X3.0X1 7/1/2013
DP/0745 PHARMACEUT PHARMACEUTIC N MISTELWEG-1389, ORDINARY 0.0
ICALS LIMITED ALS LIMITED TRABAD ROAD, DHOLKA TABLETS TABLET
387 810, DISTRICT BLISTER
AHMEDABAD, GUJARAT,
INDIA
394 NDA/MAL/H COSMOS LTD ASTRA PHARMA DTS-Z KIT TABLET-ZINC, TABLET- COSMOS LIMITED, KENYA- KENYA ORAL LIQUID 1.0X4.0X1 7/1/2013
DP/0746 (U) LIMITED SACHET-NACL 54.89MG , RANGWE ROAD, OFF ORDINARY 0.3 G
+ KCL + SACHET LUNGA ROAD, INDUSTRIAL UNIT DOSE SACHET +
TRISODIUM 1.3G + AREA POWDERS 1.0X10.0
CITRATE + 0.75G + NAIROBI - KENYA TABLET
ANHYDROUS 1.45G + BLISTER
GLUCOSE 6.75G
395 NDA/MAL/H MEDIPHARM MEDIPHARM ORALYTE GLUCOSE 13.5G + : MEDIPHARM INDUSTRIES UGANDA ORAL LIQUID 1.0X20.8 7/1/2013
DP/0747 SALES INDUSTRIES ORANGE ANHYDROUS 2.6G + LTD-PLOT 65, KAKAJJO ORDINARY G SACHET
LIMITED (E.A) LTD CO-PACK + SODIUM 2.9G + ROAD, BWEYOGERERE OTHER SOLID + 60 ML
CHLORIDE + 1.5G/ POSTAL ADDRESS SPECIAL BOTTLE
TRISSODIUM SACHET + : P.O.BOX 5917, FORMS
CITRATE 27.43MG/5 KAMPALA.
DEHYDRATE + ML
POTASSIUM
CHLORIDE /
ZINC
SULPHATE
396 NDA/MAL/H BAYER SURGIPHARM XARELTO RIVAROXABA 15MG BAYER PHARMA AG 51368 GERMANY ORAL SOLID 1.0X14.0 7/1/2013
DP/0748 PHARMA (U) LIMITED 15MG N LEVERKUSEN-BAYER ORDINARY TABLET
PHARMA AG 51368 FILM- BLISTER
LEVERKUSEN COATED
TABLETS
397 NDA/MAL/H AUROBINDO PHILLIPS MEROGRA MEROPENEM 1000MG AURONEXT PHARMA PVT INDIA PARENTERAL 1.0X1.0 G 7/1/2014
DP/0749 PHARMA LTD PHARMACEUTIC M 1000 LTD.-A- 1128 RIICO ORDINARY VIAL
ALS (UGANDA) INDUSTRIAL AREA, PHASE DRY VIALS
LIMITED III, DISTALWAR, BHIWADI
398 NDA/MAL/H BAYER SURGIPHARM XARELTO RIVAROXABA 20MG BAYER PHARMA AG 51368 GERMANY ORAL SOLID 1.0X14.0 7/1/2013
DP/0750 PHARMA (U) LIMITED 20MG N LEVERKUSEN-BAYER ORDINARY TABLET
LEVERKUSEN COATED
TABLETS
399 NDA/MAL/H MICRO LABS LABOREX DOLOWIN ACECLOFENA 100MG MICRO LABS LTD--NO 92, INDIA ORAL SOLID 1.0X3.0X1 7/1/2013
DP/0751 LIMITED UGANDA C SIPCOT, HOSUR-635 126,, ORDINARY 0.0
LIMITED TAMIL NADU, INDIA TABLETS TABLET
BLISTER
400 NDA/MAL/H AUROBINDO PHILLIPS MEROGRA MEROPENEM 500MG AURONEXT PHARMA INDIA PARENTERAL 1.0X500.0 7/1/2014
DP/0753 PHARMA LTD PHARMACEUTIC M 500 PRIVATE LIMITED,-A-1128, ORDINARY MG VIAL
ALS (UGANDA) RIICO INDUSTRIAL AREA, DRY VIALS
LIMITED PHASE-III,BHIWADI-
301019, DISTRICT- ALWAR
(RAJASTHAN), INDIA.
401 NDA/MAL/H DENK PARMA BENLE CONSULT TORAS TORASEMIDE 10MG DENK PHARMA GMBH GERMANY ORAL SOLID 1.0X3.0X1 7/1/2015
DP/0754 GMBH & CO. LIMITED DENK 10 &CO.KG-- ORDINARY 0.0
KG PRINZREGENTESTR.79.816 TABLETS TABLET
75 MUENCHEN, BLISTER
GERMANY, GOLLSTR, 1-D-
845529 TITTMONING
GERMANY
402 NDA/MAL/H TROIKAA ABACUS T- DOL TRAMADOL 50MG/ML TROIKAA INDIA PARENTERAL 1.0X5.0X2 7/1/2014
DP/0755 PHARMACEUT PHARMA HYDROCHLOR PHARMACEUTICALS ORDINARY .0 ML
ICALS LIMITED (AFRICA) IDE LIMITED..-THOL, DIST AMPOULES AMPOULE
LIMITED MEHSANA PIN 382728,
GUJARAT
403 NDA/MAL/H CADILA ABACUS TOLFREE TOLPERISONE 100MG CADILA HEALTHCARE INDIA ORAL SOLID 1.0X10.0X 7/1/2014
DP/0756 HEALTH CARE PHARMA 100 LIMITED -KUNDAIM ORDINARY 10.0
LIMITED (AFRICA) INDUSTRIAL ESTATE,PLOT FILM- TABLET
LIMITED NO.203-213, KUNDAIM COATED BLISTER
GOA, 403115, TABLETS
404 NDA/MAL/H CADILA ABACUS TOLFREE TOLPERISONE 150MG CADILA HEALTHCARE INDIA ORAL SOLID 1.0X10.0X 7/1/2014
DP/0757 HEALTH CARE PHARMA 150 LIMITED -KUNDAIM ORDINARY 10.0
405 NDA/MAL/H MICRO LABS PHARMA VILLE COTRIMOX COTRIMOXAZ 960MG MICRO LABS LTD--NO 92, INDIA ORAL SOLID 1.0X1000. 7/1/2011
DP/0759 LTD LIMITED AZOLE OLE SIPCOT, HOSUR-635 126,, ORDINARY 0 TABLET
TAMIL NADU, INDIA TABLETS CONTAIN
ER,1.0X10
.0X10.0
TABLET
BLISTER,1.
0X3.0X10.
0 TABLET
BLISTER
406 NDA/MAL/H UNICHEM EUROPA CORVADIL 5 AMLODIPINE 5MG UNICHEM LABORATORIES INDIA ORAL SOLID 1.0X3.0X1 7/1/2011
DP/0764 LABORATORIE HEALTHCARE LIMITED UNIT II-VILLAGE ORDINARY 0.0
S LTD (U) LTD BHATAULI KALAN BADDI TABLETS TABLET
DIST SOLAN HIMACHAL STRIP
PRADESH 173 205
407 NDA/MAL/H PHARM UNITED LEVOPLANT LEVONORGES 75MG SHANGHAI DAHUA CHINA PARENTERAL 1.0X10.0X 7/1/2010
DP/0765 ACCESS HEALTHCARE TREL PHARMACEUTICAL CO. RETARD 2.0 ROD
AFRICA LTD DISTRIBUTORS LTD-CHANG ZENG FARM, IMPLANTS IMPLANT
LTD CHONGMING COUNTY,
SHANGHAI
408 NDA/MAL/H FDC LTD AIVEEN (U) PYRIMON DEXAMETHAS 1%W/V + FDC LIMITED -B-8, INDIA OPHTHALMI 1.0X5.0 7/1/1999
DP/0768 LIMITED EYE DROP ONE/CHLORA 0.1%W/V M.I.D.C., INDUSTRIAL C DROPS ML
MPHENICOL AREA, WALUJ – BOTTLE
AURANGABAD- 431 136
MAHARASHTRA, INDIA.
409 NDA/MAL/H MEGA ABACUS LIGABA - PREGABALIN 150MG MSN LABORATORIES LTD- INDIA ORAL SOLID 1.0X3.0X1 7/1/2014
DP/0772 LIFESCIENCES PHARMA 150 PLOT 42 ANRICH ORDINARY 0.0
(AUSTRALIA) (AFRICA) INDUSTRIAL ESTATE CAPSULES CAPSULE
PTY LTD LIMITED BOLLARAM MEDAK BLISTER
PRADESH
410 NDA/MAL/H MEGA ABACUS LIGABA - 75 PREGABALIN 75MG MSN LABORATORIES LTD- INDIA ORAL SOLID 1.0X3.0X1 7/1/2014
DP/0775 LIFESCIENCES PHARMA PLOT 42 ANRICH ORDINARY 0.0
(AUSTRALIA) (AFRICA) INDUSTRIAL ESTATE CAPSULES CAPSULE
PTY LTD LIMITED BOLLARAM MEDAK BLISTER
PRADESH
411 NDA/MAL/H FREDUN PLANET FREMOL PARACETAM 500MG FREDUN INDIA ORAL SOLID 1.0X10.0X 7/1/1999
DP/0776 PHARMACEUT PHARMACEUTIC TABLETS OL TABLETS PHARMACEUTICALS LTD- ORDINARY 10.0
ICALS LTD ALS UGANDA 14,15,16 ZORBIAN TABLETS TABLET
LTD INDUSTRIAL COMPLEX BLISTER,1.
VEOOR PALGHAR EAST 0X1000.0
INDIA TABLET
CONTAIN
ER
412 NDA/MAL/H CADILA ABACUS ATORVA ATORVASTATI 10MG CADILA HEALTHCARE INDIA ORAL SOLID 1.0X5.0X1 7/1/2001
DP/0780 HEALTH CARE PHARMA TABLETS N LIMITED--KUNDAIM ORDINARY .0X7.0
LIMITED (AFRICA) INDUSTRIAL ESTATE, PLOT TABLETS TABLET
LIMITED NO. 203-213, BLISTER,1.
KUNDAIM,GOA-403 115, 0X3.0X10.
INDIA 0 TABLET
BLISTER
413 NDA/MAL/H TRIVENI AIVEEN (U) TRICOLD PARACETAM 500MG/10 TRIVENI FORMULATIONS INDIA ORAL SOLID 1.0X10.0X 7/1/2013
DP/0781 FORMULATIO LIMITED OL/PHENYLEP MG/30MG LIMITED --PLOT NO 52- ORDINARY 10.0
NS LIMITED HRINE /2MG 54,62-64 ALEAP TABLETS TABLET
HYDROCHLOR INDUSTRIAL ESTATE BLISTER,1.
IDE/CAFFEINE SURAMPALLI (V) 0X50.0X4.
ANHYDROUS/ VIJAYAWADA A.P 0 TABLET
CHLORPHENI BLISTER
RAMINE
414 NDA/MAL/H TRIVENI AIVEEN (U) CYPOLIVE CYPROHEPTA 4 MG TRIVENI FORMULATIONS INDIA ORAL SOLID 1.0X2.0X5 7/1/2013
DP/0783 FORMULATIO LIMITED DINE LIMITED--PLOT NO: ORDINARY 0.0
NS LIMITED HYDROCHLOR 52,53,54, 62,63 & 64 TABLETS TABLET
IDE ALEAP INDUSTRIAL BLISTER
ESTATE SURAMPALI
VILLAGE, GANNAVARAM
MANDAL KRISHNA (DT)
A.P
415 NDA/MAL/H COSMOS LTD ASTRA PHARMA HEMOSAN FERROUS 300MG COSMOS LIMITED, KENYA- KENYA ORAL SOLID 1.0X3.0X1 7/1/2013
DP/0784 (U) LIMITED FUMERATE RANGWE ROAD, OFF ORDINARY 0.0
LUNGA ROAD, INDUSTRIAL CAPSULES CAPSULE
AREA BLISTER
NAIROBI - KENYA
416 NDA/MAL/H TRIVENI AIVEEN (U) TRIDANTIN NITROFURAN 100 MG TRIVENI FORMULATIONS INDIA ORAL SOLID 1.0X10.0X 7/1/2013
DP/0788 FORMULATIO LIMITED TOIN LIMITED .- PLOT NO 52,53- ORDINARY 10.0
NS LIMITED 54,63-64 ALEAP TABLETS TABLET
INDUSTRIAL ESTATE BLISTER
SURAMPALLI VILLAGE
GANNAVARAN MANDAL
KRISHNA
417 NDA/MAL/H GITTOES GITTOES AGOPEN- PHENOXYME 250MG MILAN LABORATORIES INDIA ORAL SOLID 1.0X1000. 7/1/2013
DP/0795 PHARMACEUT PHARMACEUTIC 250 THYL (INDIA) PVT LTD .-PLOTS ORDINARY 0 TABLET
ICALS LIMITED ALS LIMITED PENICILLIN 63,67,87,35,36,64,65, TABLETS CONTAIN
POTASSIUM JAWAHAR CO-OP IND. ER,1.0X10
ESTATE LTD, KAMOTHE, .0X10.0
PANVEL (NAVI MUMBAI) TABLET
BLISTER
418 NDA/MAL/H HETERO LABS AIVEEN (U) AMLO-H 5 AMLODIPINE 5MG HETERO LABS LTD. UNIT INDIA ORAL SOLID 1.0X10.0X 7/1/2013
DP/0796 LTD LIMITED BESILATE (V) .-S.N0.439, 440, 441& ORDINARY 10.0
458, APIIC, PHARMA SEZ, TABLETS TABLET
POLLEPALLY (VILLAGE), BLISTER
JADCHERLA (MANDAL)
509301 INDIA.
419 NDA/MAL/H NVS KENYA SURGIPHARM AFINITOR EVEROLIMUS 5MG NORVATIS PHARMA STEIN SWITZERLAN ORAL SOLID 1.0X30.0 7/1/2015
DP/0797 LTD (U) LIMITED 5MG AG-SCHAFF HAUSER D ORDINARY TABLET
STRASSE 4332, STEIN - TABLETS BLISTER
SWITZERLAND
420 NDA/MAL/H HETERO LABS AIVEEN (U) AMLOSIN AMLODIPINE 10MG HETERO LABS LTD (UNIT- INDIA ORAL SOLID 1.0X10.0X 7/1/2013
DP/0798 LTD LIMITED 10 BESILATE V)-SY.NO.438,439,440 & ORDINARY 10.0
SEZ, POLEPALLY (V), BLISTER,1.
JEDCHERLA (M) 0X3.0X10.
MAHABOOBNAGAR 0 TABLET
PRADESH - INDIA
421 NDA/MAL/H NVS KENYA SURGIPHARM AFINITOR EVEROLIMUS 10MG NORVATIS PHARMA STEIN SWITZERLAN ORAL SOLID 1.0X30.0 7/1/2015
DP/0799 LTD (U) LIMITED 10MG AG-SCHAFF HAUSER D ORDINARY TABLET
STRASSE 4332, STEIN - TABLETS BLISTER
SWITZERLAND
422 NDA/MAL/H NOVARTIS SURGIPHARM EXFORGE AMLODIPINE 5MG+ NOVARTIS PHARMA STEIN SWITZERLAN ORAL SOLID 1.0X4.0X7 7/1/2015
DP/0802 PHARMA AG (U) LIMITED HCT 5MG/ + VALSARTAN 160MG+ AG- D ORDINARY .0 TABLET
160MG/12. + 12.5MG SCHAFFHARVSERTRASSE FILM- BLISTER
5MG HYDROCHLOR CH-4332 STEIN COATED
OTHIAZIDE SWITZERLAND. NOVARTIS TABLETS
FARMACEUTICA SA-
RONDA DE SANTA
MARIA,158, E-08210
BARBERA DEL VALLES
BARCELONA SPAIN
423 NDA/MAL/H PIRAMAL TATA UGANDA ISOFLURAN ISOFLURANE 250ML PIRAMAL ENTERPRISES INDIA OTHER 1.0X250.0 7/1/2005
DP/0808 HEALTHCARE LIMITED E LTD, INDIA-DIGWAL SYSTEMIC ML
LTD VILLAGE KOHIR MENDAL LIQUID BOTTLE,1.
MEDAK DISTRICT,ANDHRA INHALATION 0X100.0
PRADESH S ML
BOTTLE
424 NDA/MAL/H MICRO LABS LABOREX DOLOWIN - ACECLOFENA 200MG MICRO LABS LTD-92, INDIA ORAL SOLID 1.0X3.0X1 7/1/2013
DP/0811 LIMITED UGANDA SR C SIPCOT INDUSTRIAL ORDINARY 0.0
LIMITED COMPLEX HOSU R-635126 FILM- TABLET
(T.N) INDIA COATED BLISTER
TABLETS
425 NDA/MAL/H DENK PARMA BENLE CONSULT GLIMEPIRID GLIMEPIRIDE 2MG DENK PHARMA GMBH & GERMANY ORAL SOLID 1.0X3.0X1 7/1/2012
DP/0816 GMBH & CO. LIMITED E DENK 2 CO. KG -GOLLSTR. 1 84529 ORDINARY 0.0
KG TITTMONING TABLETS TABLET
BLISTER
426 NDA/MAL/H MERCK (PTY) UNITED FIXIME CEFIXIME 400MG NKUNZI SOUTH ORAL SOLID 1.0X5.0 7/1/2015
DP/0820 LTD HEALTHCARE 400MG PHARMACEUTICALS-259 AFRICA ORDINARY TABLET
DISTRIBUTORS DAVIDSON ROAD, FILM- BLISTER,1.
LTD WADEVILLEGERMISTON, COATED 0X1.0
1428 SOUTH AFRICA TABLETS TABLET
BLISTER,1.
0X1.0X10.
0 TABLET
BLISTER
427 NDA/MAL/H DENK PARMA BENLE CONSULT GLIMEPIRID GLIMEPIRIDE 3MG DENK PHARMA GMBH & GERMANY ORAL SOLID 1.0X3.0X1 7/1/2012
DP/0821 GMBH & CO. LIMITED E DENK 3 CO. KG -GOLLSTR. 1 84529 ORDINARY 0.0
KG TITTMONING TABLETS TABLET
BLISTER
428 NDA/MAL/H ABACUS ABACUS CLOXCIN- CLOXACILLIN 500MG REYOUNG CHINA PARENTERAL 1.0X50.0X 7/1/2014
DP/0822 PHARMA LTD PHARMA 500 SODIUM PHARMACEUTICAL CO. ORDINARY 0.5 G VIAL
(AFRICA) LTD-NO. 6 ERLANGSHAN DRY VIALS
SHANDONG 256100
429 NDA/MAL/H CADILA ABACUS TRAP TRAMADOL 37.5MG+3 CADILA HEALTHCARE LTD- INDIA ORAL SOLID 1.0X10.0X 7/1/2013
DP/0823 HEALTH CARE PHARMA TABLETS HCL + 25MG KUNDAIM INDUSTRIAL ORDINARY 10.0
LIMITED (AFRICA) PARACETAM ESTATE, PLOT NO.203- FILM- TABLET
LIMITED OL 213, KUNDAIM GOA, COATED BLISTER
403115, INDIA TABLETS
430 NDA/MAL/H I CARE VITACARE LTD CLOXACILLI CLOXACILLIN 250MG REYOUNG INDIA ORAL SOLID 1.0X10.0X 7/1/2013
DP/0824 PHARMA N PHARMACEUTICAL CO. ORDINARY 10.0
LIMITED LTD-NO. 6 ERLANGSHAN CAPSULES CAPSULE
ROAD, YIYUAN, BLISTER,1.
SHANDONG 256100 0X1000.0
MEDICO REMEDIES PVT CAPSULE
LTD,.-8 & 9 DEWAN AND CONTAIN
SONS, UDYOG NAGAR, ER
PALGHAR, DIST. THANE-
401404, MAHARSHITRA
431 NDA/MAL/H I CARE VITACARE LTD AMOXYCILL AMOXYCILLIN 250MG REYOUNG INDIA ORAL SOLID 1.0X10.0X 7/1/2013
DP/0826 PHARMA IN PHARMACEUTICAL CO. ORDINARY 10.0
LIMITED LTD-NO. 6 ERLANGSHAN CAPSULES CAPSULE
ROAD, YIYUAN, BLISTER,1.
SHANDONG 256100 0X1000.0
401404, MAHARSHITRA
432 NDA/MAL/H MERCK (PTY) UNITED EUTHYROX LEVOTHYROXI 25 MCG MERCK KGAA - - GERMANY ORAL SOLID 1.0X1.0X3 7/1/2015
DP/0830 LTD HEALTHCARE 25 MCG NE SODIUM FRANKFRUTER STRASSE ORDINARY 0.0
DISTRIBUTORS 250, D-64293,DARMSTADT- TABLETS TABLET
LTD GERMANY BLISTER,1.
0X4.0X25.
0 TABLET
BLISTER
433 NDA/MAL/H I CARE VITACARE LTD AMPICILLIN AMPICILLIN 250MG REYOUNG CHINA ORAL SOLID 1.0X10.0X 7/1/2013
DP/0831 PHARMA CAPSULES PHARMACEUTICAL CO. ORDINARY 10.0
LIMITED LTD-NO. 6 ERLANGSHAN OTHER CAPSULE
ROAD, YIYUAN, CAPSULES BLISTER,1.
SHANDONG 256100 0X1000.0
401404, MAHARSHITRA
434 NDA/MAL/H MERCK UNITED EUTHYROX LEVOTHYROXI 100MCG MERCK KGAA - - GERMANY ORAL SOLID 1.0X4.0X2 7/1/2015
DP/0832 HEALTHCARE 100MCG NE FRANKFRUTER STRASSE ORDINARY 5.0
0X1.0X30.
0 TABLET
BLISTER
435 NDA/MAL/H LINCOLN METRO VOMI-6 DOXYLAMINE 10MG + LINCOLN INDIA ORAL SOLID 1.0X10.0X 7/1/2013
DP/0834 PHARMACEUT PHARMACEUTIC SUCCINATE & 10MG PHARMACEUTICALS ORDINARY 1.0X10.0
ICALS LTD ALS LIMITED PYRIDOXINE LIMITED.-TRIMUL ESTATE ENTERIC- TABLET
HYDROCHLOR NEAR KHATRAJ CHOKADI COATED BLISTER
IDE KHATRAJ 382721 TABLETS
GHANDHINAGAR
GUJARAT
436 NDA/MAL/H GITTOES GITTOES AGOBIS BISACODYL 5MG AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1.0X10.0X 7/1/2013
ICALS LIMITED ALS LIMITED II,VASAI,TALUKA INDL CO- ENTERIC- TABLET
PADA,VASAI(E)DIST.THAN TABLETS 0X1000.0
E INDIA TABLET
CONTAIN
ER
437 NDA/MAL/H LINCOLN METRO CALBONE- CALCIUM 1250MG + LINCOLN INDIA ORAL SOLID 1.0X3.0X1 7/1/2012
DP/0836 PHARMACEUT PHARMACEUTIC 500 CARBONATE 250 I.U PHARMACEUTICALS ORDINARY .0X10.0
ICALS LTD ALS LIMITED + LIMITED -10, 12, 13, TABLETS TABLET
COLECALCIFE TRIMUL ESTATE, AFTER BLISTER,1.
ROL VADSCAR VILLAGE, NEAR 0X10.0X10
KHATRAJ CHOKADI, .0 TABLET
KHATRAJ-382721, BLISTER
GHANDHINAGAR,
GUJARAT, INDIA
438 NDA/MAL/H LINCOLN METRO SAC SECNIDAZOLE 1000MG LINCOLN INDIA ORAL SOLID 1.0X1.0X2 7/1/2013
DP/0842 PHARMACEUT PHARMACEUTIC PHARMACEUTICALS ORDINARY .0 TABLET
ICALS LTD ALS LIMITED LIMITED -10, 12, 13, FILM- BLISTER
TRIMUL ESTATE, AFTER COATED
KHATRAJ CHOKADI,
KHATRAJ-382721,
GHANDHINAGAR,
GUJARAT, INDIA
439 NDA/MAL/H MACLEODS NORVIK MOXIMAC MOXIFLOXACI 400MG MACLEODS INDIA ORAL SOLID 1.0X5.0 7/1/2014
DP/0846 PHARMACEUT ENTERPRISES N PHARMACEUTICALS LTD-- ORDINARY TABLET
ICALS LTD LIMITED PLOT 25-27 SURVEY NO. FILM- BLISTER
366 PREMIER INDUSTRIAL COATED
ESTATE KACHIGAM TABLETS
DAMAN
440 NDA/MAL/H MACLEODS NORVIK MACROZID PYRAZINAMI 500MG MACLEODS INDIA ORAL SOLID 1.0X10.0X 7/1/2014
DP/0848 PHARMACEUT ENTERPRISES E 500 DE PHARMACEUTICALS LTD--- ORDINARY 10.0
ICALS LTD LIMITED PLOT NO 25-27 SURVEY TABLETS TABLET
PREMEIRE INDUSTRIAL BLISTER,1.
ESTATE KACHIGAM 0X100.0
DAMAN (U.T) 396401 TABLET
CONTAIN
ER
441 NDA/MAL/H LINCOLN METRO LCT KIT LANSOPRAZO 30MG + LINCOLN INDIA ORAL SOLID 1.0X7.0X1 7/1/2012
DP/0850 PHARMACEUT PHARMACEUTIC LE + 250MG + PHARMACEUTICALS ORDINARY .0X6.0
ICALS LTD ALS LIMITED CLARITHROM 500MG LIMITED -10, 12, 13, FILM- TABLET
YCIN + TRIMUL ESTATE, AFTER COATED BLISTER
TINIDAZOLE VADSCAR VILLAGE, NEAR TABLETS (BLISTER
KHATRAJ CHOKADI, CONTAINS
KHATRAJ-382721, 2
GHANDHINAGAR, CAPSULES
GUJARAT, INDIA AND 4
TABLETS)
442 NDA/MAL/H RANBAXY STAR BRUSTAN IBUPROFEN + 5% W/W+ RANBAXY LABORATORIES INDIA TOPICAL 1.0X50.0 7/1/2012
DP/0853 LABORATORIE PHARMACEUTIC GEL LEVOMENTH 3%W/W LTD GOA-NO.2 MADKAI EXTERNAL G
S LTD GOA ALS LTD OL INDUSTRIAL ESTATE GOA LOTIONS CONTAIN
403 404 ER
443 NDA/MAL/H GLENMARK STAR IBICAR-50 BECLOMETAS 50MCG GLENMARK INDIA LUNG 1.0X200.0 7/1/2013
DP/0854 PHARMACUTI PHARMACEUTIC ONE PER PHARMACEUTICALS LTD ADMINISTRA METERED
CALS LTD ALS LTD ACTUATIO (UNIT III).-UNIT III VILLAGE TION DOSE
N KISHANPURA,BADDI- METERED- CANNISTE
NALAGARH ROAD TEHSIL DOSE R
BADDI,DISTT. SOLAN, INHALER
HIMACHAL PRADESH -173
205 INDIA
444 NDA/MAL/H HETERO LABS AIVEEN (U) LAZINE LEVOCETIRIZI 5MG HETERO LABS LTD-22-110 INDIA ORAL SOLID 1.0X10.0X 7/1/2013
DP/0855 LTD LIMITED NE IDA JEEDIMETLA ORDINARY 10.0
DIHYDROCHL HYDERABAD 500-055 FILM- TABLET
ORIDE ANDHRA PRADESH COATED BLISTER,1.
TABLETS 0X10.0
TABLET
BLISTER
445 NDA/MAL/H GLENMARK STAR CANDID-V6 CLOTRIMAZO 100MG GLENMARK INDIA VAGINAL 1.0X6.0 7/1/2000
DP/0857 PHARMACEUT PHARMACEUTIC VAGINAL LE PHARMACEUTICALS LTD- TABLETS PESSARY
ICAL LTD ALS LTD TABLETS PLOT NO E -37, 39 ,D STRIP
446 NDA/MAL/H ASTRAZENEC MACNAUGHTON PLENDIL FELODIPINE 5MG ASTRAZENECA AB,- SWEDEN ORAL SOLID 1.0X30.0 7/1/2001
DP/0858 A LIMITED GARTUNA & SNACKVIKEN ORDINARY TABLET
STOCKHOLM TABLETS CONTAIN
ER
447 NDA/MAL/H MSN METRO FLOXSAFE MOXIFLOXACI 400MG MSN LABORATORIES LTD- INDIA ORAL SOLID 1.0X5.0 7/1/2012
DP/0860 LABORATORIE PHARMACEUTIC 400 N PLOT 42 ANRICH ORDINARY TABLET
S PRIVATE ALS LIMITED HYDROCHLOR INDUSTRIAL ESTATE FILM- BLISTER
LIMITED IDE BOLLARAM MEDAK COATED
PRADESH
448 NDA/MAL/H SAKAR ROYAL PHARMA PROZINE PROMETHAZI 25MG/ML SAKAR HEALTHCARE PVT. INDIA PARENTERAL 2.0X5.0X2 7/1/2013
DP/0861 HEALTH CARE 2011 LIMITED NE LTD-PLOT 10/13 SAKHEJ- ORDINARY .0 ML
PVT .LTD BAVLA ROAD, AMPOULES AMPOULE
AHMEDABAD,GUJURAT,IN
DIA
449 NDA/MAL/H GLENMARK STAR IBICAR- 200 BECLOMETAS 200MCG GLENMARK INDIA LUNG 1.0X200.0 7/1/2013
205 INDIA
450 NDA/MAL/H HETERO LABS AIVEEN (U) PANTIN-40 PANTOPRAZO 40 MG HETERO LABS LIMITED INDIA ORAL SOLID 1.0X10.0X 7/1/2013
DP/0864 LTD UNIT IX LIMITED LE SODIUM UNIT V-APIIC PHARMA ORDINARY 10.0
SEZ, S. NO. 439, 440, 441 ENTERIC- TABLET
& 458 COATED BLISTER
POLEPALLY TABLETS
VILLAGE, JADCHERLA
MANDAL,
MAHABOOBNAGAR
(DISTRICT). PIN
509301
451 NDA/MAL/H GLENMARK STAR LIZOLID LINEZOLID 2MG/ML AMANTA HEALTHCARE INDIA PARENTERAL 1.0X300.0 7/1/2013
DP/0866 PHARMACEUT PHARMACEUTIC LIMITED-PLOT NO. 876 ORDINARY ML
ICAL LTD ALS LTD N.H. NO. 8 VILLAGE- INFUSION BOTTLE,1.
HIRIYALA TALUKA, VIALS/BOTTL 0X100.0
MATAR, DIST KHEDA-387 ES ML
411, GUJARAT BOTTLE
452 NDA/MAL/H HETERO LABS AIVEEN (U) PANTIN-20 PANTOPRAZO 20MG HETERO LABS LIMITED INDIA ORAL SOLID 1.0X10.0X 7/1/2013
DP/0867 LTD UNIT IX LIMITED LE SODIUM UNIT V-APIIC PHARMA ORDINARY 10.0
SEZ, S. NO. 439, 440, 441 ENTERIC- TABLET
POLEPALLY TABLETS
VILLAGE, JADCHERLA
MANDAL,
MAHABOOBNAGAR
(DISTRICT). PIN
509301
453 NDA/MAL/H SAKAR ROYAL PHARMA VARMIKA- AMIKACIN 500MG SAKAR HEALTH CARE PVT, INDIA PARENTERAL 1.0X2.0X5 7/1/2013
DP/0868 HEALTH CARE 2011 LIMITED 500 LTD-BLOCK NO. 10-13,M.N ORDINARY .0X2.0 ML
PVT .LTD DESAI PETROL AMPOULES AMPOULE
PUMP,SARKHEJ-BAVLA
ROAD,VILLAGE
CHANGODAR DIST
AHMEDABAD 382-
213,GUJARAT-INDIA
454 NDA/MAL/H SAKAR ROYAL PHARMA LARTRM ARTEMETHER 80MG/ML SAKAR HEALTH CARE PVT, INDIA PARENTERAL 1.0X6.0X1 7/1/2013
DP/0869 HEALTH CARE 2011 LIMITED LTD-BLOCK NO. 10-13,M.N ORDINARY I .0 ML
PVT .LTD DESAI PETROL M AMPOULE
PUMP,SARKHEJ-BAVLA AMPOULES
ROAD,VILLAGE
CHANGODAR DIST
AHMEDABAD 382-
213,GUJARAT-INDIA
455 NDA/MAL/H TROIKAA ABACUS TROY-K PHYTOMENA 10MG/ML TROIKAA INDIA PARENTERAL 1.0X10.0X 7/1/2010
DP/0870 PHARMACEUT PHARMA DIONE PHARMACEUTICALS ORDINARY 1.0 ML
ICALS LIMITED (AFRICA) LIMITED-THOL, DIST. AMPOULES AMPOULE
LIMITED MEHSANA-382728,
GUJARAT,INDIA
456 NDA/MAL/H SAKAR ROYAL PHARMA DEXA DEXAMETHAS 4MG/ML SAKAR HEALTH CARE PVT, INDIA PARENTERAL 2.0X6.0X2 7/1/2013
DP/0871 HEALTH CARE 2011 LIMITED ONE SODIUM LTD-BLOCK NO. 10-13,M.N ORDINARY .0 ML
PVT .LTD DESAI PETROL DRY VIALS VIAL
PUMP,SARKHEJ-BAVLA
ROAD,VILLAGE
CHANGODAR DIST
AHMEDABAD 382-
213,GUJARAT-INDIA
457 NDA/MAL/H GITTOES GITTOES OXYTOCIN OXYTOCIN 10I.U/ML NINGBO DAHONGYING CHINA PARENTERAL 1.0X10.0X 7/1/2009
DP/0873 PHARMACEUT PHARMACEUTIC INJECTION PHARMACEUTICAL CO LTD- ORDINARY 1.0 ML
ICALS LIMITED ALS LIMITED NO 396, MINGZHU ROAD AMPOULES AMPOULE
NINGBO CITY CHINA
458 NDA/MAL/H LEBEN ANDYCO LEBASMA-4 SALBUTAMOL 4MG LEBEN LABORATORIES PVT INDIA ORAL SOLID 1.0X20.0X 7/1/2014
S PVT LTD (UGANDA) LTD AKOLA 444 104 TABLETS TABLET
0X10.0X10
.0 TABLET
BLISTER
459 NDA/MAL/H LEBEN ANDYCO ANTAGIT DRIED 400MG + LEBEN LABORATORIES PVT INDIA ORAL LIQUID 1.0X1.0X1 7/1/2007
DP/0877 LABORATORIE PHARMACY DS GEL ALUMINIUM 400MG + LTD --L4 PHASEIII M.I.D.C ORDINARY 70.0 ML
S LTD (UGANDA) LTD MINT HYDROXIDE + 50MG AKOLA 444 104 SUSPENSION BOTTLE
FLAVOUR MAGNESIUM MAHARASHTRA S
HYDROXIDE +
SIMETHICONE
460 NDA/MAL/H COSMOS LTD. ASTRA PHARMA TRIBEES THIAMINE + 200MG + COSMOS LIMITED, KENYA- KENYA ORAL SOLID 1.0X2.0X1 7/1/2012
DP/0879 (U) LIMITED FORTE FILM PYRIDOXINE + 50MG RANGWE ROAD, OFF ORDINARY 0.0
COATED CYANOCOBAL +1000MCG LUNGA ROAD, INDUSTRIAL FILM- TABLET
TABLETS AMIN AREA COATED BLISTER
NAIROBI - KENYA TABLETS
461 NDA/MAL/H MERCK UNITED GLUCOVAN METFORMIN 500MG + MERCK SANTE S.A.S- FRANCE ORAL SOLID 1.0X2.0X1 7/1/2012
DP/0882 HEALTHCARE CE + 2.5MG CENTRE DE PRODUCTION ORDINARY 5.0
DISTRIBUTORS 500MG/2.5 GLIBENCLAMI DE SEMOY 2 RUE DU FILM- TABLET
LTD MG DE PRESSIOR VERT 45400 COATED BLISTER,1.
SEMOY TABLETS 0X4.0X15.
0 TABLET
BLISTER
462 NDA/MAL/H MERCK UNITED GLUCOVAN METFORMIN 500MG + MERCK SANTE S.A.S- FRANCE ORAL SOLID 1.0X2.0X1 7/1/2012
DP/0883 HEALTHCARE CE + 5MG CENTRE DE PRODUCTION ORDINARY 5.0
DISTRIBUTORS 500MG/5M GLIBENCLAMI DE SEMOY 2 RUE DU FILM- TABLET
LTD G DE PRESSIOR VERT 45400 COATED BLISTER,1.
SEMOY TABLETS 0X4.0X15.
0 TABLET
BLISTER
463 NDA/MAL/H ABACUS ABACUS DNS SODIUM 0.9%W/V + ABACUS PARENTERAL UGANDA PARENTERAL 1.0X250.0 7/1/2012
DP/0889 PARENTERAL PARENTERAL CHLORIDE + 5% W/V DRUGS LIMITED-BLOCK ORDINARY ML
DRUGS DRUGS LIMITED GLUCOSE 191, PLOT NO. 114, INFUSION BOTTLE,1.
LIMITED GWAWANYA KINGA AND VIALS/BOTTL 0X500.0
KAPEKA MUKONO ES ML
DISTRICT, UGANDA. BOTTLE
464 NDA/MAL/H ASTRA MACNAUGHTON ONGLYZA SAXAGLIPTIN 2.5MG BRISTOL-4601 HIGHWAY UNITED ORAL SOLID 1.0X30.0 7/1/2013
DP/0892 ZENECA LIMITED 62 EAST MOUNT VERNON STATES ORDINARY TABLET
INDIANA 47620 TABLETS CONTAIN
USA ER
465 NDA/MAL/H HETERO LABS AIVEEN (U) GIAGRA SILDENAFIL 100MG HETERO LABS LTD. UNIT INDIA ORAL SOLID 1.0X4.0X1 7/1/2014
DP/0894 LTD LIMITED 100 CITRATE (V)-439, 440, 441& 458, ORDINARY 0.0
POLLEPALLY (VILLAGE), COATED BLISTER,1.
JADCHERLA (MANDAL) TABLETS 0X4.0
MAHABOOB NAGAR (DIST)- TABLET
509301 INDIA. BLISTER
466 NDA/MAL/H VIRCHOW SURGIPHARM HYORTH SODIUM 10MG/1ML VIRCHOW BIOTECH PVT, INDIA PARENTERAL 1.0X2.0 7/1/2015
DP/0895 HEALTHCARE (U) LIMITED HYALURONAT LTD-SURVEY NO. 172, ORDINARY ML PRE-
PVT LTD E PART GAGILLAPUR, PRE-FILLED FILLED
QUTHBULLAPUR, R.R, DIST SYRINGES SYRINGE
467 NDA/MAL/H VIRCHOW SURGIPHARM DEBRIDACE PAPAIN + 521700UNI VIRCHOW BIOTECH PVT, - INDIA TOPICAL 1.0X15.0 7/1/2015
DP/0897 HEALTHCARE (U) LIMITED UREA TS+100MG SURVEY NO. 172, PART EXTERNAL G TUBE
PVT LTD /G GAGILLAPUR, OINTMENTS
QUTHBULLAPUR, R.R,
DISTRICT TELANGANA
468 NDA/MAL/H VIRCHOW SURGIPHARM VIRIAXONE CEFTRIAXONE 1G INJECTCARE PARENTERALS INDIA PARENTERAL 1.0X1.0 G 7/1/2013
DP/0899 HEALTHCARE (U) LIMITED PVT. LTD.-PLOT130 ORDINARY VIAL + 10
PVT LTD SILVASSA ROAD GIDC VAPI DRY VIALS ML VIAL
396195 GUJARAT WFI
469 NDA/MAL/H GITTOES GITTOES AGOPINE NIFEDIPINE 20MG AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1.0X10.0X 7/1/2013
DP/0902 PHARMACEUT PHARMACEUTIC SR NO.33,SECTOR RETARD 10.0
OP ESTATE LTD,GAURAI COATED BLISTER
PADA,VASAI(E)DIST.THAN TABLETS
E INDIA
470 NDA/MAL/H GLAXO UNITED ZANTAC RANITIDINE 50MG/2ML GLAXO SMITHKLINE ITALY PARENTERAL 1.0X2.0 7/1/1997
DP/0903 WELLCOME(K HEALTHCARE MANUFACTURING S.P.A .- ORDINARY ML
ENYA) LTD DISTRIBUTORS STARDA PROVINCIALE AMPOULES AMPOULE
LTD ASOLANA 90, 43056 SAN
POLO DI TORRILE (PARMA)
471 NDA/MAL/H ASTRA MACNAUGHTON ONGLYZA SAXAGLIPTIN 5MG BRISTOL-4601 HIGHWAY UNITED ORAL SOLID 1.0X30.0 7/1/2013
DP/0904 ZENECA LIMITED 62 EAST MOUNT VERNON STATES ORDINARY TABLET
INDIANA 47620 FILM- CONTAIN
USA ASTRA ZENECA UK COATED ER
LIMITED-ASTRAZENECA UK TABLETS
LIMITED SILK ROAD
BUSINESS PARK, MACCLES
FIELD,CHESHIRE SK 10
2NA,
472 NDA/MAL/H NECTAR AIVEEN (U) NECPOD CEFPODOXIM 200MG NECTAR LIFESCIENCES LTD INDIA ORAL SOLID 1.0X10.0X 7/1/2013
DP/0905 LIFESCIENCES LIMITED E PROXETIL UNIT VI-BHATOLIKALAN ORDINARY 10.0
LTD P.O BAROTIWALA DISTT TABLETS TABLET
SOLAN HIMACHAL STRIP
PRADESH 173205
473 NDA/MAL/H VIRCHOW SURGIPHARM IONSIL SILVER 0.2%W/W VIRCHOW BIOTECH PVT, - INDIA TOPICAL 1.0X15.0 7/1/2015
DP/0906 HEALTHCARE (U) LIMITED NITRATE SURVEY NO. 172, PART EXTERNAL G TUBE
PVT LTD GAGILLAPUR, GELS AND
QUTHBULLAPUR, R.R, SOLS
DISTRICT TELANGANA
474 NDA/MAL/H NECTAR AIVEEN (U) CEFUAXIT CEFUROXIME 250MG NECTAR LIFE SCIENCES INDIA ORAL SOLID 1.0X10.0 7/1/2013
DP/0907 LIFESCIENCES LIMITED AXETIL LTD--UNIT VI ORDINARY TABLET
LTD BHATOLIKALAN DIST TABLETS STRIP
SOLAN H.P
475 NDA/MAL/H NECTAR AIVEEN (U) FIXINECT CEFIXIME 100MG NECTAR LIFESCIENCES LTD INDIA ORAL SOLID 1.0X10.0 7/1/2013
DP/0909 LIFESCIENCES LIMITED UNIT VI-BHATOLIKALAN ORDINARY TABLET
LTD P.O BAROTIWALA DISTT FILM- STRIP
SOLAN HIMACHAL COATED
PRADESH 173205 TABLETS
476 NDA/MAL/H VIRCHOW SURGIPHARM HEALACE RECOMBINAN 100MCG/G VIRCHOW BIOTECH PVT, INDIA TOPICAL 1.0X15.0 7/1/2015
DP/0911 HEALTHCARE (U) LIMITED T HUMAN LTD-SURVEY NO. 172, EXTERNAL G TUBE
PVT LTD PLATELET PART GAGILLAPUR, GELS AND
DERIVED QUTHBULLAPUR, R.R, DIST SOLS
GROWTH
FACTOR -B
477 NDA/MAL/H NOVARTIS SURGIPHARM FEMARA LETROZOLE 2.5MG NORVATIS PHARMA STEIN SWITZERLAN ORAL SOLID 1.0X3.0X1 7/1/2013
DP/0913 PHARMA (U) LIMITED AG-SCHAFF HAUSER D ORDINARY 0.0
STRASSE 4332, STEIN - TABLETS TABLET
SWITZERLAND BLISTER
478 NDA/MAL/H VIRCHOW SURGIPHARM OSTEOTIDE TERIPARATID 250MCG/ VIRCHOW BIOTECH PVT INDIA PARENTERAL 1.0X3.0 7/1/2015
DP/0914 HEALTHCARE (U) LIMITED E ML LTD -SURVEY NO. 172, ORDINARY ML
PVT LTD [RECOMBINA PART GAGILLAPUR, VIALS VIAL,1.0X
NT HUMAN QUTHBULLAPUR, R.R, 3.0 ML
PARATHYROI DISTRICT ANDHRA PREFILLED
D HORMONE PRADESH PEN
(1-34)]
INJECTION
479 NDA/MAL/H NOVARTIS SURGIPHARM CURAM AMOXICILLIN 875 MG + SANDOZ GMBH- AUSTRIA ORAL SOLID 1.0X7.0X2 7/1/2014
DP/0915 PHARMA (U) LIMITED + 125 MG BIOCHEMIESTRASSE 10, ORDINARY .0 TABLET
SERVICES INC CLAVULANIC A6250 KUNDL, TYROL, FILM- STRIP
ACID AUSTRIA COATED
TABLETS
480 NDA/MAL/H TROIKAA ABACUS BUPITROY BUPIVACAINE 5MG/ML TROIKAA INDIA PARENTERAL 1.0X5.0X4 7/1/2012
DP/0920 PHARMACEUT PHARMA HEAVY HYDROCHLOR PHARMACEUTICALS LTD .- ORDINARY .0 ML
ICALS LIMITED (AFRICA) IDE SARA INDUSTRIAL ESTATE VIALS VIAL
LIMITED SELAQUI DEHRADUN
248197 UTTARAKHAND,
INDIA
481 NDA/MAL/H MICRO LABS LABOREX BACTOCLAV- AMOXICILLIN 250MG + MICRO LABS LIMITED.- INDIA ORAL SOLID 1.0X6.0 7/1/2004
DP/0926 LIMITED UGANDA 375 +CLAVULANA 125MG PLOT 16, VEERASANDRA ORDINARY TABLET
LIMITED TE IND. AREA,ANEKAL TALUK, TABLETS STRIP,1.0X
POTASSIUM BANGALORE INDIA 2.0X10.0
TABLET
STRIP
482 NDA/MAL/H AJANTA ABACUS INSTACLOP CLOPIDOGREL 75MG AJANTA PHARMA LIMITED- INDIA ORAL SOLID 1.0X3.0X1 7/1/2013
DP/0928 PHARMA LTD PHARMA 75 AJANTA PHARMA LIMITED ORDINARY 0.0
(AFRICA) B-4-5-6, MIDC AREA TABLETS TABLET
LIMITED PAITHAN, AURANGABAD, STRIP
431148
DIST:AURANGABAD
MAHARASHTRA, INDIA.
483 NDA/MAL/H IPCA MEDVIN DUOQUIN DIHYDROART 40MG IPCA LABORATORIES LTD- INDIA ORAL SOLID 10.0X1.0X 7/1/2012
DP/0929 LABORATORIE PHARMA EMISININ + +320MG PLOT NO. 255/1, ORDINARY 9.0
S LTD LIMITED PIPERAQUINE VILLAGE ATHAL, TABLETS TABLET
PHOSPHATE SILVASSA-396230, BLISTER,1
DADRA AND NAGAR 0.0X1.0X8
HAVELI, INDIA. .0 TABLET
BLISTER
484 NDA/MAL/H LINCOLN METRO ARH ALPHA-BETA 75MG/ML SAKAR HEALTHCARE PVT. INDIA PARENTERAL 1.0X3.0X1 7/1/2012
DP/0931 PHARMACEUT PHARMACEUTIC JUNIOR ARTEETHER LTD-PLOT 10/13 SAKHEJ- ORDINARY .0 ML
ICALS LTD ALS LIMITED BAVLA ROAD, AMPOULES AMPOULE
DIA
485 NDA/MAL/H CADILA ABACUS ODIMONT 4 MONTELUKAS 4MG CADILA HEALTHCARE LTD INDIA ORAL SOLID 1.0X3.0X1 7/1/2011
DP/0934 HEALTH CARE PHARMA T SARKHEJ-BAVLA NH NO.8A ORDINARY 0.0
LIMITED (AFRICA) MORAIYA TAL SANAND CHEWABLE TABLET
LIMITED DISTRICT AHMEDABAD COATED BLISTER
382210 TABLETS
486 NDA/MAL/H FEROZSONS HARLEYS ESOMEGA ESOMEPRAZO 20MG FEROZSONS INDIA ORAL SOLID 1.0X2.0X7 7/1/2013
DP/0938 LABORATORIE UGANDA 20MG LE AS LABORATORIES LTD- ORDINARY .0
S LTD LIMITED MAGNESSIU AMANGARH-NOWSHERA, CAPSULES CAPSULE
M (KHYBER BLISTER
TRIHYDRATE
PELLETS PAKHTOONKHWA),
PAKISTAN
487 NDA/MAL/H LINCOLN METRO ARH ALPHA -BETA 150MG SAKAR HEALTHCARE PVT. INDIA PARENTERAL 1.0X3.0X2 7/1/2012
DP/0939 PHARMACEUT PHARMACEUTIC ARTEETHER /2ML LTD-PLOT 10/13 SAKHEJ- ORDINARY .0 ML
DIA
488 NDA/MAL/H FEROZSONS HARLEYS ESOMEGA ESOMEPRAZO 40MG FEROZSONS INDIA ORAL SOLID 1.0X2.0X7 7/1/2013
DP/0940 LABORATORIE UGANDA 40MG LE AS LABORATORIES LTD- ORDINARY .0
S LTD LIMITED MAGNESSIU AMANGARH-NOWSHERA, CAPSULES CAPSULE
M (KHYBER BLISTER
TRIHYDRATE
PELLETS PAKHTOONKHWA),
PAKISTAN
489 NDA/MAL/H AJANTA ABACUS ZAHA AZITHROMYCI 200MG/5 AJANTA PHARMA LIMITED- INDIA ORAL LIQUID 1.0X15.0 7/1/2013
DP/0941 PHARMA LTD PHARMA N ML 31-0 MIDC INDUSTRIAL ORDINARY ML
(AFRICA) AREA CHIKALTHANA SUSPENSION BOTTLE
LIMITED 431210 DIST S
AURANGABAD
MAHARASHTRA STATE
490 NDA/MAL/H LINCOLN METRO ARH FORTE ALPHA -BETA 225MG/ SAKAR HEALTHCARE PVT. INDIA PARENTERAL 1.0X3.0X3 7/1/2012
DP/0942 PHARMACEUT PHARMACEUTIC ARTEETHER 3ML LTD-PLOT 10/13 SAKHEJ- ORDINARY .0 ML
DIA
491 NDA/MAL/H ASTRAZENEC MACNAUGHTON TENORETIC ATENOLOL + 100 MG + ASTRA ZENECA UK UNITED ORAL SOLID 1.0X14.0 7/1/1997
DP/0946 A LIMITED CHLORTHALID 25 MG LIMITED-SILK ROAD KINGDOM ORDINARY TABLET
ONE BUSINESS FILM- BLISTER,1.
PARK,MACCLESFIELD,CHES COATED 0X2.0X14.
HIRE SK 10 2NA, TABLETS 0 TABLET
BLISTER
492 NDA/MAL/H COSMOS LTD ASTRA PHARMA LORHISTIN LORATADINE 5MG/5ML COSMOS LIMITED-- KENYA ORAL LIQUID 1.0X60.0 7/1/2013
DP/0948 (U) LIMITED A SYRUP RANGWA ROAD, OFF ORDINARY ML
5MG/5ML LUNGA LUNGA ROAD,P.O LIQUIDS BOTTLE
BOX 414 33, NAIORBI
INDUSTRIAL AREA
493 NDA/MAL/H NEON AIVEEN (U) NORAD STERILE 2MG/2ML NEON LABORATORIES LTD- INDIA PARENTERAL 1.0X5.0X2 7/1/2013
DP/0951 LABARATORIE LIMITED NORADRENAL PLOT NO. 29-32, 57 & 60, ORDINARY S .0 ML
S LTD INE PALGHAR TALUKA CO- C AMPOULES AMPOULE
CONCENTRAT OPERATIVE ESTATE ,
E BOISAR ROAD
494 NDA/MAL/H NEON AIVEEN (U) EFECATAL CEFTRIAXONE 1G NEON LABORATORIES LTD- INDIA PARENTERAL 1.0X1.0 G 7/1/2013
DP/0952 LABARATORIE LIMITED PLOT NO. 29-32, 57 & 60, ORDINARY VIAL
S LTD PALGHAR TALUKA CO- DRY VIALS
OPERATIVE ESTATE ,
BOISAR ROAD
495 NDA/MAL/H NEON AIVEEN (U) CIZCAN CISPLATIN 10MG/10 NEON LABORATORIES LTD- INDIA PARENTERAL 1.0X10.0 7/1/2013
DP/0953 LABARATORIE LIMITED ML PLOT NO. 29-32, 57 & 60, ORDINARY ML VIAL
S LTD PALGHAR TALUKA CO- VIALS
OPERATIVE ESTATE ,
BOISAR ROAD
496 NDA/MAL/H NEON AIVEEN (U) ANAWIN BUPIVACAINE 50MG/20 NEON LABORATORIES LTD- INDIA PARENTERAL 1.0X20.0 7/1/2013
DP/0954 LABARATORIE LIMITED ML PLOT NO. 29-32, 57 & 60, RETARD ML VIAL
S LTD PALGHAR TALUKA CO- OTHER VIALS
OPERATIVE ESTATE ,
BOISAR ROAD
497 NDA/MAL/H MACK SHURIK LTD LYRED VITAMINE A + 2500 IU + TORQUE INDIA ORAL LIQUID 1.0X200.0 7/1/2012
DP/0957 BROWN SYRUP VITAMINE E 10 IU + PHARMACEUTICALS PVT ORDINARY ML
PHARMACEUT ACETATE + 50MG + LTD-ISAAPUR P.O DAPPAR SYRUPS BOTTLE
ICALS PVT ASCORBIC 35MCG + 140056 INDIA
LIMITED ACID + 3MG
SELENIUM +
ZINC
498 NDA/MAL/H AJANTA ABACUS ARTEFAN ARTEMETHER 20MG + AJANTA PHARMA LIMITED INDIA ORAL SOLID 1.0X12.0 7/1/2013
DP/0959 PHARMA LTD PHARMA DISPERSIBL + 120MG PAITHAN- ORDINARY TABLET
31-0 (AFRICA) E 20/120 LUMEFANTRI MANUFACTURING UNIT B- SOLUBLE BLISTER,1.
LIMITED NE 4/5/6 MIDC PAITHAN TABLETS 0X6.0
DISTRICT AURANGABAD TABLET
431 148 MAHARASTRA BLISTER,1.
STATE INDIA 0X30.0X6.
0 TABLET
BLISTER,1.
0X30.0X12
.0 TABLET
BLISTER
499 NDA/MAL/H AJANTA ABACUS APMOD ARTESUNATE 50MG+135 AJANTA PHARMA LTD--B- INDIA ORAL SOLID 1.0X3.0 7/1/2013
DP/0963 PHARMA LTD PHARMA +AMODIAQUI MG 4/5/6 MIDC INDUSTRIAL ORDINARY TABLET
(AFRICA) NE AREA PAITHAN 431 128 LAYERED BLISTER
LIMITED AURANGABAD TABLETS
500 NDA/MAL/H AJANTA ABACUS APMOD 25 ARTESUNATE 25 MG + AJANTA PHARMA LTD--B- INDIA ORAL SOLID 1.0X1.0X3 7/1/2013
DP/0964 PHARMA LTD PHARMA / 67.5 + 67.5 MG 4/5/6 MIDC INDUSTRIAL ORDINARY .0 TABLET
(AFRICA) AMODIAQUIN AREA PAITHAN 431 128 LAYERED BLISTER
LIMITED E AURANGABAD TABLETS
501 NDA/MAL/H EMCURE HARLEYS ASOMEX- AMLODIPINE 2.5MG EMCURE INDIA ORAL SOLID 1.0X5.0X1 7/1/2005
DP/0969 PHARMACEUT UGANDA 2.5 BESILATE PHARMACEUTICALS LTD - ORDINARY 0.0
ICALS LTD LIMITED LANE NO.3 PHASE II,SIDCO TABLETS TABLET
INDUSTRIAL BLISTER
COMPLEX,BARI-
BRAHMANA JAMMU 181
133, INDIA
502 NDA/MAL/H PHARCO ECHO AZOMYCIN AZITHROMYCI 200 PHARCO EGYPT ORAL LIQUID 1.0X15.0 7/1/2013
DP/0972 PHARMACEUT PHARMACY (U) N DIHYDRATE MG/5ML PHARMACEUTICALS LTD- ORDINARY ML
ICALS LIMITED KILO 31 ALEXANDRIA, DRY BOTTLE
COMPANY CAIRO DESERT ROAD, SUSPENSION
LTD ARAB REPUBLIC OF EGYPT. S/SYRUPS/D
P. O BOX 12, SIDI GABER, ROPS
ALEXANDRIA EGYPT
503 NDA/MAL/H SQUARE GAMA CEF-3 CEFIXIME 100MG/5 SQUARE BANGLADESH ORAL LIQUID 1.0X50.0 7/1/2015
DP/0974 CEPHALOSPO PHARMACEUTIC ML CEPHALOSPORINS LTD- ORDINARY ML
RINS LTD ALS (U) LIMITED KALIAKOIR, GAZIPUR – DRY BOTTLE
1750, BANGLADESH SUSPENSION
S/SYRUPS/D
ROPS
504 NDA/MAL/H PHARCO ECHO CETRAK CETIRIZINE 5MG/5ML PHARCO EGYPT ORAL LIQUID 1.0X120.0 7/1/2013
DP/0975 PHARMACEUT PHARMACY (U) SYRUP DIHYDROCHL PHARMACEUTICALS LTD- ORDINARY ML
ICALS LIMITED ORIDE KILO 31 ALEXANDRIA, SYRUPS BOTTLE
CAIRO DESERT ROAD,
ARAB REPUBLIC OF EGYPT.
P. O BOX 12, SIDI GABER,
ALEXANDRIA EGYPT
505 NDA/MAL/H SQUARE GAMA AMBROX AMBROXOL 75MG SQUARE BANGLADESH ORAL SOLID 1.0X3.0X1 7/1/2012
DP/0978 PHARMACEUT PHARMACEUTIC 75 SR PHARMACEUTICALS ORDINARY 0.0
ICALS LTD ALS (U) LIMITED CAPSULE LIMITED-KALIAKOIR CAPSULES CAPSULE
GAZIPUR – 1750, BLISTER
BANGLADESH
506 NDA/MAL/H PHARCO ECHO AZOMYCIN AZITHROMYCI 250MG PHARCO EGYPT ORAL SOLID 1.0X1.0X6 7/1/2013
DP/0980 PHARMACEUT PHARMACY (U) N PHARMACEUTICALS LTD- ORDINARY .0
ICALS LIMITED KILO 31 ALEXANDRIA, CAPSULES CAPSULE
CAIRO DESERT ROAD, BLISTER
ALEXANDRIA EGYPT
507 NDA/MAL/H HOVID BHD UNITED CLOFENAC DICLOFENAC 100MG HOVID BERHAD (CHEMOR MALAYSIA ORAL SOLID 1.0X10.0X 7/1/2008
DP/0981 HEALTHCARE SR TABLETS SODIUM SITE)--LOT 56442, 71/2, RETARD 10.0
DISTRIBUTORS JALAN IPOH/CHEMOR FILM- TABLET
LTD 31200, PERAK. MALAYSIA COATED BLISTER
TABLETS
508 NDA/MAL/H ASTRA LIFE ASTRA PHARMA ASMETO-10 METOCLOPRA 10MG ASTRA LIFE CARE (INDIA) INDIA ORAL SOLID 1.0X10.0X 7/1/2014
DP/0982 CARE (INDIA) (U) LIMITED MIDE PVT-SURVEY NO.57/P, ORDINARY 10.0
PVT LTD SARKHEJ-BAVLA OTHER TABLET
HIGHWAY, POST- RAJOD- COATED BLISTER,1.
382220, TALUKA-BAVLA, TABLETS 0X1000.0
DIST-AHMEDABAD. TABLET
CONTAIN
ER
509 NDA/MAL/H CADILA KARURI JOVAN T20 TADALAFIL 20MG CADILA INDIA ORAL SOLID 1.0X1.0X1 7/1/2013
ICALS ALS LTD. LIMITED-1389, TRASAD TABLETS TABLET
STATE, INDIA
510 NDA/MAL/H EVA PHARMA WIDE CONVENTI GABAPENTIN 100MG EVA PHARMA FOR EGYPT ORAL SOLID 1.0X3.0X1 7/1/2013
DP/0986 SPECTRUM N PHARMACEUTICALS AND ORDINARY 0.0
ENTERPRISES MEDICAL APPLIANCES-176 CAPSULES CAPSULE
(U) LIMITED EL SADAT ST. KAFR EL BLISTER
GABAL, PYRAMIDS, GIZA,
EGYPT
511 NDA/MAL/H SQUARE GAMA ALATROL CETIRIZINE 10MG SQUARE BANGLADESH ORAL SOLID 1.0X10.0X 7/1/2013
DP/0987 PHARMACEUT PHARMACEUTIC TABLETS PHARMACEUTICALS ORDINARY 10.0
ICALS LTD ALS (U) LIMITED LIMITED-KALIAKOIR FILM- TABLET
GAZIPUR – 1750, COATED BLISTER
BANGLADESH TABLETS
512 NDA/MAL/H CADILA ESCORTS CADITOR 20 ATORVASTATI 20MG CADILA INDIA ORAL SOLID 1.0X3.0X1 7/1/2013
ICALS LIMITED ALS LIMITED LIMITED-1389, TRASAD FILM- TABLET
ROAD, DHOLKA- 382225, COATED BLISTER
STATE, INDIA
513 NDA/MAL/H EVA PHARMA WIDE FUSIDERM FUSIDIC ACID 2%W/W EVA PHARMA FOR EGYPT TOPICAL 1.0X15.0 7/1/2013
DP/0990 SPECTRUM CREAM PHARMACEUTICALS AND EXTERNAL G TUBE
ENTERPRISES MEDICAL APPLIANCES-176 CREAMS
(U) LIMITED EL SADAT ST. KAFR EL
EGYPT
514 NDA/MAL/H LINCOLN METRO FLUCOMOL PARACETAM 250MG + LINCOLN INDIA ORAL LIQUID 1.0X100.0 7/1/2014
DP/0995 PHARMACEUT PHARMACEUTIC OL + 5MG + PHARMACEUTICALS LTD-- ORDINARY ML
ICALS LTD ALS LIMITED PHENYLEPHRI 10MG + TRIMUL ESTATE AFER SUSPENSION BOTTLE
NE HCL + 2MG VODSAR VILLAGE KHATJAT S
DEXTROMET 382 721 GUJARAT VADSAR
HORPHAN P.O.J TALUKA KALOH DIST
HBR + GANDHINAGAR INDIA
CHLORPHENI
RAMINE
MALEATE
515 NDA/MAL/H EVA PHARMA WIDE GENUPHIL GLUCOSAMIN 375MG+37 EVA PHARMA FOR EGYPT ORAL SOLID 1.0X3.0X1 7/1/2013
DP/0997 SPECTRUM E SULPHATE 5MG+300 PHARMACEUTICALS AND ORDINARY 0.0
ENTERPRISES SODIUM MG MEDICAL APPLIANCES-176 TABLETS TABLET
(U) LIMITED CHLORIDE+M EL SADAT ST. KAFR EL BLISTER
ETHYLSULPH GABAL, PYRAMIDS, GIZA,
ONYLMETHA EGYPT
NE+CHONDR
OITIN
SULPHATE
516 NDA/MAL/H EVA PHARMA WIDE THIOEVA THIOTIC ACID 600MG EVA PHARMA FOR EGYPT ORAL SOLID 1.0X2.0X1 7/1/2014
DP/0999 SPECTRUM PHARMACEUTICALS AND ORDINARY 0.0
ENTERPRISES MEDICAL APPLIANCES-176 FILM- TABLET
(U) LIMITED EL SADAT ST. KAFR EL COATED BLISTER
GABAL, PYRAMIDS, GIZA, TABLETS
EGYPT
517 NDA/MAL/H TROIKAA ABACUS TROYCURIU ATRACURIUM 10MG/ML TROIKAA INDIA PARENTERAL 1.0X5.0X3 7/1/2012
DP/1000 PHARMACEUT PHARMA M PHARMACEUTICALS ORDINARY .0 ML
ICALS LIMITED (AFRICA) LIMITED-THOL, DIST. AMPOULES AMPOULE
LIMITED MEHSANA-382728, ,1.0X5.0X2
GUJARAT,INDIA .5 ML
AMPOULE
518 NDA/MAL/H EVA PHARMA WIDE THIOEVA THIOTIC ACID 300MG EVA PHARMA FOR EGYPT ORAL SOLID 1.0X3.0X1 7/1/2013
ENTERPRISES MEDICAL APPLIANCES-176 FILM- TABLET
(U) LIMITED EL SADAT ST. KAFR EL COATED BLISTER
GABAL, PYRAMIDS, GIZA, TABLETS
EGYPT
519 NDA/MAL/H MICRO LABS PHILLIPS TRIPRIDE-2 GLIMEPIRIDE 2MG+15M MICRO LABS LTD 92 INDIA ORAL SOLID 1.0X3.0X1 7/1/2012
DP/1006 LTD PHARMACEUTIC + G+500MG SIPCOT -92 SIPCOT ORDINARY 0.0
ALS (UGANDA) PIOGLITAZON HOSUR 635 126 TAMIL TABLETS TABLET
LIMITED E+ NADU BLISTER
METFORMIN
520 NDA/MAL/H COSMOS LTD ASTRA PHARMA ZINCOS ZINC 20MG COSMOS LIMITED, KENYA- KENYA ORAL SOLID 1.0X10.0X 7/1/2013
DP/1007 (U) LIMITED DISPERSIBL SULPHATE RANGWE ROAD, OFF ORDINARY 10.0
E TABLETS LUNGA ROAD, INDUSTRIAL SOLUBLE TABLET
20MG AREA TABLETS BLISTER
NAIROBI - KENYA
521 NDA/MAL/H TROIKAA ABACUS BUPITROY BUPIVACAINE 5MG/ML TROIKAA INDIA PARENTERAL 1.0X20.0 7/1/2012
DP/1009 PHARMACEUT PHARMA 0.5% PHARMACEUTICALS LTD .- ORDINARY ML VIAL
ICALS LIMITED (AFRICA) SARA INDUSTRIAL ESTATE VIALS
248197 UTTARAKHAND,
INDIA
522 NDA/MAL/H COSMOS LTD ASTRA PHARMA DABORAL AMINOSIDINE 125MG/5 COSMOS LIMITED, KENYA- KENYA ORAL LIQUID 1.0X60.0 7/1/2012
DP/1011 (U) LIMITED SYRUP ML RANGWE ROAD, OFF ORDINARY ML
LUNGA ROAD, INDUSTRIAL SYRUPS BOTTLE
AREA
NAIROBI - KENYA
523 NDA/MAL/H NEON AIVEEN (U) LOX 2% LIDOCAINE 2% W/V NEON LABORATORIES LTD- INDIA PARENTERAL 1.0X50.0 7/1/2013
DP/1012 LABARATORIE LIMITED PLOT NO. 29-32, 57 & 60, ORDINARY ML
S LTD PALGHAR TALUKA CO- OTHER VIALS VIAL,1.0X
OPERATIVE ESTATE , 20.0 ML
BOISAR ROAD VIAL
524 NDA/MAL/H NEON AIVEEN (U) THIOSOL THIOPENTAL 500MG NEON LABORATORIES LTD- INDIA PARENTERAL 1.0X1.0X2 7/1/2013
DP/1013 LABARATORIE LIMITED SODIUM PLOT NO. 29-32, 57 & 60, ORDINARY 0.0 ML
S LTD PALGHAR TALUKA CO- DRY VIALS VIAL
OPERATIVE ESTATE ,
BOISAR ROAD
525 NDA/MAL/H DAWA SUPER MEDIC ORACEF CEFALEXIN 250MG DAWA LTD -PLOT KENYA ORAL SOLID 1.0X10.0X 7/1/2013
RUARAKA NAIROBI CAPSULES CAPSULE
BLISTER
526 NDA/MAL/H ELYS VELVET ELYCLOX AMPICILLIN/C 125MG/12 ELYS CHEMICAL KENYA ORAL LIQUID 1.0X100.0 7/1/2015
DP/1017 CHEMICAL PHARMA LOXACILLIN 5MG INDUSTRIES LIMITED- ORDINARY ML
INDUSTRIES LIMITED ROAD B’, OFF ENTERPRISE DRY BOTTLE
LTD ROAD SUSPENSION
PLOT NO. 209/8927 S/SYRUPS/D
INDUSTRIAL AREA ROPS
527 NDA/MAL/H LINCOLN METRO PA-12 PARACETAM 1000MG LINCOLN INDIA ORAL SOLID 1.0X10.0X 7/1/2012
DP/1020 PHARMACEUT PHARMACEUTIC OL PHARMACEUTICALS RETARD 1.0X12.0
ICALS LTD ALS LIMITED SUSTAINED LIMITED-10, 12, 13, LAYERED TABLET
RELEASE TRIMUL ESTATE, AFTER TABLETS BLISTER
VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI,
KHATRAJ-382721,
GHANDHINAGAR,
GUJARAT, INDIA
528 NDA/MAL/H PT NOVELL ECHO CLINDAMYC CLINDAMYCI 150MG PT NOVELL INDONESIA ORAL SOLID 1.0X5.0X1 7/1/2013
DP/1021 PHARMACEUT PHARMACY (U) IN N PHARMACEUTICAL ORDINARY 0.0
ICAL LIMITED LABORATORIES -J1 CAPSULES CAPSULE
LABORATORIE WANAHERANG NO. 35, BLISTER
S TLAJUNG UDIK, GUNUNG
PUTRI, BORGO 16962
INDONESIA
529 NDA/MAL/H EVA PHARMA WIDE CONVENTI GABAPENTIN 300MG EVA PHARMA FOR EGYPT ORAL SOLID 1.0X3.0X1 7/1/2013
DP/1022 SPECTRUM N PHARMACEUTICALS AND ORDINARY 0.0
(U) LIMITED EL SADAT ST. KAFR EL BLISTER
EGYPT
530 NDA/MAL/H MYLAN KIMSY MEDS ZINNIA P LEVONORGES 150MCG + MYLAN LABORATORIES INDIA ORAL SOLID 1.0X28.0 7/1/2013
DP/1023 LABORATORIE LTD TREL + 30MCG LIMITED.--PLOT NO. 1606- ORDINARY TABLET
S LIMITED ETHINYLESTR 1609, SARIGAM TABLETS BLISTER,3.
ADIOL INDUSTRIAL AREA, GIDC, 0X28.0
SARIGAM, TAL-UMERGAM, TABLET
DIST VALSAD, 396155, BLISTER
PLOT NO.20 & 21,
PHARMEZ, SARKHEJ-
BAVLA NATIONAL
531 NDA/MAL/H SANOFI SURGIPHARM INSUMAN INSULIN 100IU/ML SANOFI-AVENTIS GERMANY PARENTERAL 1.0X10.0 7/1/2014
DP/1025 –AVENTIS (U) LIMITED COMB 30 HUMAN DEUTSCHLAND GMBH - ORDINARY S ML
DEUTSCHLAN INDUSTRIEPARK HOECHST, C VIALS VIAL,1.0X
D BRUNINGSTRASSEN, 3.0 ML
BUILDING PRE-
H650 65926 FRANKFURT FILLED
AM MAIN, GERMANY SYRINGE
532 NDA/MAL/H BIOCON LTD ABACUS INSUGEN R INSULIN 100 IU/ML BIOCON LIMITED-SPECIAL INDIA PARENTERAL 1.0X10.0 7/1/2012
DP/1026 PHARMA (REGULAR) HUMAN ECONOMIC ZONE PLOT ORDINARY S ML
(AFRICA) 204 PHASE IV C VIALS VIAL,1.0X
LIMITED BOMMASANDRA JIGANI 1.0X5.0X3
LINK ROAD .0 ML
CARTRIDG
E
533 NDA/MAL/H BIOCON LTD ABACUS INSUGEN-N INSULIN 100 IU/ML BIOCON LIMITED-SPECIAL INDIA PARENTERAL 1.0X10.0 7/1/2012
DP/1027 PHARMA (NPH) HUMAN ECONOMIC ZONE PLOT ORDINARY S ML
(AFRICA) 204 PHASE IV C VIALS VIAL,1.0X
LINK ROAD .0 ML
CARTRIDG
E
534 NDA/MAL/H BIOCON LTD ABACUS INSUGEN - INSULIN 30/70I.U/ BIOCON LIMITED-SPECIAL INDIA PARENTERAL 1.0X10.0 7/1/2012
DP/1028 PHARMA 30/70 HUMAN ML ECONOMIC ZONE PLOT ORDINARY S ML
(AFRICA) (BIPHASIC) 204 PHASE IV C VIALS VIAL,1.0X
LINK ROAD .0 ML
CARTRIDG
E
535 NDA/MAL/H EVA PHARMA WIDE MOXIFLOX MOXIFLOXACI 400MG EVA PHARMA FOR EGYPT ORAL SOLID 1.0X1.0X5 7/1/2013
DP/1031 SPECTRUM N PHARMACEUTICALS AND ORDINARY .0 TABLET
ENTERPRISES MEDICAL APPLIANCES-176 TABLETS BLISTER
(U) LIMITED EL SADAT ST. KAFR EL
EGYPT
536 NDA/MAL/H EVA PHARMA WIDE ARTHFREE LEFLUNOMID 20MG EVA PHARMA FOR EGYPT ORAL SOLID 1.0X10.0 7/1/2013
DP/1032 SPECTRUM 20 E PHARMACEUTICALS AND ORDINARY TABLET
ENTERPRISES MEDICAL APPLIANCES-176 TABLETS BLISTER,1.
(U) LIMITED EL SADAT ST. KAFR EL 0X3.0X10.
GABAL, PYRAMIDS, GIZA, 0 TABLET
EGYPT BLISTER
537 NDA/MAL/H VOGEN BUFFALO DURAMOX AMOXICILLIN 250MG/5 VOGEN LABORATORIES CYPRUS ORAL LIQUID 1.0X100.0 7/1/2007
DP/1034 LABORATORIE HEALTH CARE ML LTD-70, M.HERACLEOUS ORDINARY ML
S LTD LTD STR. AYIOS ATHANASIOS DRY BOTTLE
INDUSTRIAL AREA, SUSPENSION
LIMASSOL, CYPRUS S/SYRUPS/D
ROPS
538 NDA/MAL/H GUILIN STAR G-CIPROX CIPROFLOXAC 500MG GUILIN PHARMACEUTICAL CHINA ORAL SOLID 1.0X10.0 7/1/2014
DP/1035 PHARMACEUT PHARMACEUTIC IN CO.LTD.-NO.43 QUILIDIAN ORDINARY TABLET
ICAL CO.LTD ALS LTD ROAD GUILIN 541002, FILM- BLISTER
GUANGXI, CHINA COATED
TABLETS
539 NDA/MAL/H SERUM NORVIK REPOITIN RECOMBINAN 4000 SERUM INSTITUTE OF INDIA PARENTERAL 1.0X1.0X1 7/1/2013
DP/1041 INSTITUTE OF ENTERPRISES T HUMAN I.U/1ML INDIA LTD-212/2 ORDINARY .0 ML PRE-
INDIA LTD. LIMITED ERYTHROPOI HADAPSAR, PUNE, 411028, PRE-FILLED FILLED
ETIN INDIA SYRINGES SYRINGE,1
.0X1.0X1.
0 ML VIAL
540 NDA/MAL/H ARISTO NORVIK ARISTO TELMISARTA 80MG ARISTO INDIA ORAL SOLID 1.0X10.0X 7/1/2013
DP/1042 PHARMACEUT ENTERPRISES TELVAS-H N +12.5 MG PHARMACEUTICALS PVT. ORDINARY 10.0
ICALS PVT LTD LIMITED 80/12.5 +HYDROCHLO LIMITED-PLOT NO. 208, TABLETS TABLET
ROTHIAZIDE NEW INDUSTRIAL AREA STRIP,1.0X
NO. II, MANDIDEEP- 3.0X10.0
462046, DIST. - RAISEN, TABLET
MADHYA PRADESH, STRIP
INDIA.
541 NDA/MAL/H UNITED WIDE ANGINET VALSARTAN 80MG UNITED JORDAN ORAL SOLID 1.0X3.0X1 7/1/2013
DP/1044 PHARMACEUT SPECTRUM 80MG PHARMACEUTICAL ORDINARY 0.0
ICAL ENTERPRISES MANUFACTURING FILM- TABLET
MANUFACTU (U) LIMITED COMPANY LTD-P.O BOX COATED BLISTER
RING CO. LTD 69 AMMAN 11591 TABLETS
JORDAN NUZHAT SAHAB
AL-RAQEEM NERA PUBLIC
SECURITY HOUSING
542 NDA/MAL/H UNITED WIDE EXOFEN FEXOFENADI 180MG UNITED JORDAN ORAL SOLID 1.0X1.0X1 7/1/2013
DP/1047 PHARMACEUT SPECTRUM 180MG NE PHARMACEUTICAL ORDINARY 5.0
JORDAN NUZHAT SAHAB
SECURITY HOUSING
543 NDA/MAL/H UNITED WIDE EXOFEN FEXOFENADI 120MG UNITED JORDAN ORAL SOLID 1.0X1.0X1 7/1/2013
DP/1048 PHARMACEUT SPECTRUM 120MG NE PHARMACEUTICAL ORDINARY 5.0
RING 69 AMMAN 11591 TABLETS
LIMITED AL-RAQEEM NERA PUBLIC
SECURITY HOUSING
544 NDA/MAL/H GITTOES GITTOES AGOVATE BETAMETHAS 0.1%W/W AGOG PHARMA LTD-PLOT INDIA TOPICAL 1.0X15.0 7/1/2012
DP/1049 PHARMACEUT PHARMACEUTIC ONE NO. 33, SECTOR II, VASAI, EXTERNAL G TUBE
ICALS LIMITED ALS LIMITED VALERATE TALUKA INDL. OINTMENTS
545 NDA/MAL/H INTAS NORVIK AMTAS-10 AMLODIPINE 10MG INTAS PHARMACEUTICALS INDIA ORAL SOLID 1.0X2.0X1 7/1/2013
DP/1050 PHARMACEUT ENTERPRISES LTD-PLOT 457/458, ORDINARY 4.0
ICALS LIMITED LIMITED SARKHEJ BAVLA HIGHWAY TABLETS TABLET
MATODA 382 210 TAL: BLISTER,1
SANAND, AHMEDABAD, 0.0X10.0
INDIA TABLET
INTAS BLISTER
PHARMACEUTICALS
LIMITED -CAMP ROAD,
SELAQUI-248197,
DEHRADUN
(UTTARAKHAND)
546 NDA/MAL/H GITTOES GITTOES MICLOGEN MICONAZOLE 2.0%W/W+ AGOG PHARMA LTD-PLOT INDIA TOPICAL 1.0X15.0 7/1/2013
DP/1052 PHARMACEUT PHARMACEUTIC NITRATE+CLO 0.05%W/W NO.33,SECTOR EXTERNAL G TUBE
ICALS LIMITED ALS LIMITED BETASOLE +0.1W/W II,VASAI,TALUKA INDL CO- CREAMS
PROPIONATE OP ESTATE LTD,GAURAI
+GENTAMICI PADA,VASAI(E)DIST.THAN
N SULPHATE E INDIA
547 NDA/MAL/H GITTOES GITTOES AGOXIN- AMOXICILLIN 125MG MILAN LABORATORIES INDIA ORAL SOLID 1.0X2.0X1 7/1/2013
DP/1053 PHARMACEUT PHARMACEUTIC 125 DT (INDIA) PVT LTD .-PLOTS ORDINARY 0.0
ICALS LIMITED ALS LIMITED 63,67,87,35,36,64,65, SOLUBLE TABLET
JAWAHAR CO-OP IND. TABLETS BLISTER,1.
ESTATE LTD, KAMOTHE, 0X3.0X10.
PANVEL (NAVI MUMBAI) 0 TABLET
BLISTER,1.
0X10.0X10
.0 TABLET
BLISTER
548 NDA/MAL/H GITTOES GITTOES AZ-250 AZITHROMYCI 250MG AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1.0X1.0X6 7/1/2011
DP/1054 PHARMACEUT PHARMACEUTIC N NO.33,SECTOR ORDINARY .0
E INDIA
549 NDA/MAL/H DAR AL DAWA GAMA ROZITTA 40 ROSUVASTATI 40MG DAR AI DAWA-NA UR JORDAN ORAL SOLID 1.0X3.0X1 7/1/2013
DP/1055 DEVELOPMEN PHARMACEUTIC N CALCIUM PLANT,AMMAN,JORDAN ORDINARY 0.0
T AND ALS (U) LIMITED FILM- TABLET
INVESTMENT COATED STRIP
CO LTD TABLETS
550 NDA/MAL/H GITTOES GITTOES AGOVATE- BETAMETHAS 0.1%W/W AGOG PHARMA LTD-PLOT INDIA TOPICAL 1.0X1.0X1 7/1/2013
DP/1056 PHARMACEUT PHARMACEUTIC N ONE + + 0.5% NO. 33, SECTOR II, VASAI, EXTERNAL 5.0 G
ICALS LIMITED ALS LIMITED OINTMENT NEOMYCIN W/W TALUKA INDL. OINTMENTS TUBE
551 NDA/MAL/H NECTAR SUPER MEDIC FIXINECT- CEFIXIME 200MG NECTAR LIFE SCIENCES INDIA ORAL SOLID 1.0X10.0X 7/1/2013
DP/1057 LIFESCIENCES LTD 200MG LTD-VILL. BHATOLIKALAN, ORDINARY 10.0
LTD ADJOINING JHARMJRI, TABLETS TABLET
E.P.I.P TEL. STRIP
NALAGARH, DISTT. SOLAN,
H.P.-173205 INDIA
552 NDA/MAL/H SHOSAAN RENE BISACODYL BISACODYL 5MG NEM LABORATORIES PVT INDIA ORAL SOLID 1.0X1000. 7/1/2010
DP/1061 ASIC PACIFIC PHARMACY LTD TABLETS LTD-133 VASAI RD(E) 401 ORDINARY 0 TABLET
162 SB MARG. LOWER TABLETS CONTAIN
PAREL MUMBAI ER,1.0X10
.0X10.0
TABLET
BLISTER
553 NDA/MAL/H VENUS HARLEYS VANCONEX- VANCOMYCIN 500MG VENUS REMEDIES LIMITED- INDIA PARENTERAL 1.0X1.0 7/1/2013
DP/1062 REMEDIES UGANDA CP UNIT II HILL TOP ORDINARY VIAL
LTD LIMITED INDUSTRIAL ESTATE DRY VIALS CARTON
JHARMAJRI EPIP
PHASE I BHATOLI BADDI
(HP) 173205
INDIA
554 NDA/MAL/H VENUS AARON OXOL OXALIPLATIN 2MG/ML VENUS REMEDIES LTD -- INDIA PARENTERAL 1.0X5.0 7/1/2012
DP/1064 REMEDIES PHARMACEUTIC UNIT II HILL TOP ORDINARY ML VIAL
LTD ALS LTD INDUSTRIAL ESTATE VIALS
JHARMAJRI EPIP PHASE I
BHATOLI KALAN BADDI
(H.P)
555 NDA/MAL/H MACK SHURIK LTD IBUPARA IBUPROFEN+ 200MG+ TORQUE INDIA ORAL LIQUID 1.0X100.0 7/1/2010
DP/1067 BROWN PARACETAM 250MG/10 PHARMACEUTICALS LTD- ORDINARY ML
PHARMECEUT OL ML ISSAPUR P.O DAPPAR SUSPENSION BOTTLE
ICALS PVT LTD 140506 S
556 NDA/MAL/H UNICHEM EUROPA AROFF 100 ACECLOFENA 100MG UNICHEM LABORATORIES INDIA ORAL SOLID 1.0X3.0X1 7/1/2014
DP/1068 LABORATORIE HEALTHCARE C LIMITED-C–31,32 & D-10, ORDINARY 0.0
S LTD (U) LTD INDUSTRIAL AREA, TABLETS TABLET
MEERUT ROAD, BLISTER
GHAZIABAD, U.P.
557 NDA/MAL/H CIRON DRUGS RENE K-ONE PHYTOMENA 10MG/ML CIRON DRUGS & INDIA PARENTERAL 1.0X10.0X 7/1/2014
DP/1069 & PHARMACY LTD INJECTION DIONE PHARMACEUTICALS PVT ORDINARY 10.0X1.0
PHARMACEUT LTD-N-118, N-119 MIDC AMPOULES ML
ICALS PVT LTD TARAPUR BOISAR DIST AMPOULE
THANE 401506
MAHARASHTRA INDIA
558 NDA/MAL/H UNITED WIDE CO- VALSARTAN + 160 MG + UNITED JORDAN ORAL SOLID 1.0X3.0X1 7/1/2013
DP/1071 PHARMACEUT SPECTRUM ANGINET HYDROCHLOR 25 MG PHARMACEUTICAL ORDINARY 0.0
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JORDAN NUZHAT SAHAB
SECURITY HOUSING
559 NDA/MAL/H UNITED WIDE CO- VALSARTAN + 80MG + UNITED JORDAN ORAL SOLID 1.0X3.0X1 7/1/2013
DP/1072 PHARMACEUT SPECTRUM ANGINET HYDROCHLOR 12.5MG PHARMACEUTICAL ORDINARY 0.0
ICAL ENTERPRISES 80/12.5MG OTHIAZIDE MANUFACTURING FILM- TABLET
MANUFACTU (U) LIMITED COMPANY LTD .-57 COATED STRIP
RING CO. LTD UBAYBIN MUAATH STREET TABLETS
AL RAGEEM-SAHAB,
AMMAN, JORDAN
560 NDA/MAL/H GLENMARK STAR IBICAR-250 BECLOMETAS 250MCG GLENMARK INDIA LUNG 1.0X200.0 7/1/2013
205 INDIA
561 NDA/MAL/H NECTAR SUPER MEDIC CEFUAXIT CEFUROXIME 500MG NECTAR LIFE SCIENCES INDIA ORAL SOLID 1.0X10.0X 7/1/2013
DP/1074 LIFESCIENCES LTD LTD-VILL. BHATOLIKALAN, ORDINARY 10.0
LTD ADJOINING JHARMJRI, FILM- TABLET
E.P.I.P TEL. COATED STRIP
NALAGARH, DISTT. SOLAN, TABLETS
H.P.-173205 INDIA
DP/1076 PHARMACEUT SPECTRUM 4MG T SODIUM PHARMACEUTICAL ORDINARY 0.0
MANUFACTU (U) LIMITED COMPANY LTD-P.O BOX TABLETS BLISTER
RING CO. LTD 69 AMMAN 11591
JORDAN NUZHAT SAHAB
SECURITY HOUSING
563 NDA/MAL/H NECTAR AIVEEN (U) NECTRAM CEFTRIAXONE 1G NECTAR LIFESCIENCES LTD INDIA PARENTERAL 1.0X1.0X1 7/1/2013
DP/1077 LIFESCIENCES LIMITED UNIT VI-BHATOLIKALAN ORDINARY .0 G VIAL
LTD P.O BAROTIWALA DISTT DRY VIALS + 1*10 ML
SOLAN HIMACHAL WFI
PRADESH 173205 AMPOULE
564 NDA/MAL/H MICRO LABS LABOREX LEVOBACT LEVOFLOXACI 500MG AHLCON PARENTERALS INDIA PARENTERAL 1.0X100.0 7/1/2013
DP/1078 LTD UGANDA INFUSION N (INDIA) LTD-SP-917-918, ORDINARY ML
LIMITED HEMIHYDRAT PHASE-III BHIWADI- INFUSION BOTTLE
E 301019, ALWAR, VIALS/BOTTL
RAJASTHAN ES
565 NDA/MAL/H GITTOES GITTOES AGOG- QUININE 100MG/5 AGOG PHARMA LTD-PLOT INDIA ORAL LIQUID 1.0X100.0 7/1/2000
DP/1079 PHARMACEUT PHARMACEUTIC QUININE HYDROCHLOR ML NO.33,SECTOR ORDINARY ML
ICALS LIMITED ALS LIMITED SYRUP IDE II,VASAI,TALUKA INDL CO- SYRUPS BOTTLE
OP ESTATE LTD,GAURAI
E INDIA
566 NDA/MAL/H ALKEM ABACUS ZOCEF 250 CEFUROXIME 250MG ALKEM LABORATORIES INDIA ORAL SOLID 1.0X1.0X6 7/1/2009
DP/1080 LABORATORIE PHARMA TABLETS AXETIL LIMITED.-VILLAGE THANA, ORDINARY .0 TABLET
S LIMITED (AFRICA) BADDI, TEHSIL- FILM- BLISTER,1.
LIMITED NALAGARH, DISTT-SOLAN, COATED 0X1.0X10.
(HP), INDIA-173205 EAST TABLETS 0 TABLET
AFRICAN (INDIA) BLISTER
OVERSEAS-PLOT NO.1,
PHARMACITY SELAQUI
DEHRADUN – 248011
(U.K), INDIA
567 NDA/MAL/H DAWA SUPER MEDIC DACOF DIPHENHYDR 75MG + DAWA LTD -PLOT KENYA ORAL LIQUID 1.0X100.0 7/1/2013
DP/1082 LIMITED LTD PAEDIATRIC AMINE 28.5MG + NO.7879/8 BABA ROAD ORDINARY ML
HYDROCHLOR 0.55MG RUARAKA NAIROBI SYRUPS BOTTLE
IDE + SODIUM
CITRATE +
MENTHOL
568 NDA/MAL/H GALPHA AIVEEN (U) CHOCOFER IRON + FOLIC 50MG + GALPHA LABORATORIES INDIA ORAL LIQUID 1.0X200.0 7/1/2013
DP/1083 LABORATORIE LIMITED SYRUP ACID 0.5MG LIMITED-VILLAGE – ORDINARY ML
S LTD /5ML THANA BADDI, TEHSIL SYRUPS BOTTLE
BADDI
SOLAN HIMACHAL
PRADESH-173 205 INDIA
569 NDA/MAL/H DAWA SUPER MEDIC DAWA-CPM CHLORPHENI 4MG DAWA LTD-BABA DOGO KENYA ORAL SOLID 1.0X1000. 7/1/2013
DP/1084 LIMITED LTD RAMINE ROAD RUARAKA ORDINARY 0 TABLET
MALEATE TABLETS CONTAIN
ER,1.0X10
.0X10.0
TABLET
BLISTER
570 NDA/MAL/H SHOSAAN RENE SYNOGEN DIACEREIN + 50MG NEM LABORATORIES INDIA ORAL SOLID 1.0X3.0X1 7/1/2012
DP/1086 ASIC PACIFIC PHARMACY LTD TABLETS METHYL +250MG + LIMITED-133 KRISHNA ORDINARY 0.0
SULPHONYL 750MG IND. ESTATE, VASAI (E), TABLETS TABLET
METHANE + THANE – 401 210, BLISTER
GLUCOSAMIN MAHARASHTRA – INDIA
E SULPHATE
571 NDA/MAL/H GITTOES GITTOES AGOCYCLIN TETRACYCLIN 3%W/W AGOG PHARMA LTD.-PLOT INDIA TOPICAL 1.0X15.0 7/1/2013
DP/1087 PHARMACEUT PHARMACEUTIC E E NO. 33, SECTOR II, VASAI, EXTERNAL G TUBE
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572 NDA/MAL/H GALPHA AIVEEN (U) RESTUM CEFUROXIME 750MG ALKEM LABORATORIES INDIA PARENTERAL 1.0X750.0 7/1/2015
DP/1088 LABORATORIE LIMITED SODIUM LTD-VILLAGE – THANA, ORDINARY MG VIAL
S LTD BADDI TEHSIL – DRY VIALS
NALAGARH, DIST-SOLAN
(HP), INDIA – 173205
573 NDA/MAL/H MICRO LABS LABOREX GRAMOCEF- CEFIXIME 100MG/5 MICRO LABS LTD--NO. 121- INDIA ORAL LIQUID 1.0X100.0 7/1/2013
DP/1094 LTD UGANDA O-100 ML 124 4TH PHASE K.I.A.D.B ORDINARY ML
LIMITED BOMMASANDRA SUSPENSION BOTTLE
INDUSTRIAL AREA ANEKAL S
TALUK BANGALORE 560
099
574 NDA/MAL/H MICRO LABS LABOREX EROSTINE- EBASTINE 20MG MICRO LABS LTD-92, INDIA ORAL SOLID 1.0X10.0 7/1/2012
DP/1095 LTD UGANDA 20 SIPCOT INDUSTRIAL ORDINARY TABLET
LIMITED COMPLEX HOSU R-635126 FILM- BLISTER
(T.N) INDIA COATED
TABLETS
575 NDA/MAL/H GLENMARK STAR MOMATE F FUSIDIC 2.1%W/W GLENMARK INDIA TOPICAL 1.0X10.0 7/1/2012
DP/1099 PHARMACEUT PHARMACEUTIC CREAM ACID+MOME + 0.1W/W PHARMACEUTICALS LTD EXTERNAL G TUBE
ICAL LTD. ALS LTD TASONE UNIT II.-UNIT II VILLAGE CREAMS
FUROATE BHATTANWALA
NALAGARH DIST SOLAN
HIMACHAL PRADESH
576 NDA/MAL/H GITTOES GITTOES AGOVIR ACICLOVIR 5% W/W AGOG PHARMA LTD-PLOT INDIA TOPICAL 1.0X10.0 7/1/2013
DP/1100 PHARMACEUT PHARMACEUTIC SKIN NO.33,SECTOR EXTERNAL G
ICALS LIMITED ALS LIMITED CREAM II,VASAI,TALUKA INDL CO- CREAMS TUBE,1.0X
OP ESTATE LTD,GAURAI 5.0 G
PADA,VASAI(E)DIST.THAN TUBE
E INDIA
577 NDA/MAL/H GITTOES GITTOES AGOCIN NEOMYCIN 0.5% W/W AGOG PHARMA LTD-PLOT INDIA TOPICAL 1.0X15.0 7/1/2014
DP/1103 PHARMACEUT PHARMACEUTIC CREAM SULPHATE NO.33,SECTOR EXTERNAL G TUBE
ICALS LIMITED ALS LIMITED II,VASAI,TALUKA INDL CO- CREAMS
E INDIA
578 NDA/MAL/H HOVID BHD UNITED LIPIDUCE ATORVASTATI 10MG HOVID BHD -121 ,JALAN MALAYSIA ORAL SOLID 1.0X10.0X 7/1/2014
DP/1104 HEALTHCARE 10 N TUNKU ABDUL RAHMAN , ORDINARY 3.0
LTD MALAYSIA BLISTER
579 NDA/MAL/H DAWA SUPER MEDIC DERMAZIN SILVER 1%W/W / DAWA LIMITED -BABA KENYA TOPICAL 1.0X15.0 7/1/2014
DP/1105 LIMITED LTD E PLUS SULPHADIAZI 10.0%W/W DOGO RWARAKA EXTERNAL G TUBE
NE AND CREAMS
CHLORHEXIDI
NE
GLUCONATE
580 NDA/MAL/H EVA PHARMA WIDE DIACEREIN DIACEREIN 50MG EVA PHARMA FOR EGYPT ORAL SOLID 1.0X3.0X1 7/1/2013
(U) LIMITED EL SADAT ST. KAFR EL BLISTER,1.
GABAL, PYRAMIDS, GIZA, 0X2.0X10.
EGYPT 0
CAPSULE
BLISTER
581 NDA/MAL/H SERUM NORVIK HEPATITIS HEPATITIS B 10MCG SERUM INSTITUTE OF INDIA PARENTERAL 1.0X25.0X 7/1/2005
DP/1107 INSTITUTE OF ENTERPRISES B VACCINE(RDN /0.5ML INDIA LTD-212/2 ORDINARY I 5.0 ML
INDIA LTD. LIMITED VACCINE(R A) HADAPSAR, PUNE, 411028, M VIALS VIAL (10
DNA) INDIA DOSES),1.
(PAEDIATRI 0X10.0X0.
C)) 5 ML VIAL
(1 DOSE)
582 NDA/MAL/H DAWA SUPER MEDIC DAWA-CPM CHLORPHENI 2MG/5ML DAWA PHARMACEUTICALS KENYA ORAL LIQUID 1.0X60.0 7/1/2014
DP/1109 LIMITED LTD RAMINE LIMITED-PLOT 7879, BABA ORDINARY ML
MALEATE DOGO ROAD RUARAKA SYRUPS BOTTLE
583 NDA/MAL/H DAWA SUPER MEDIC FAST-ACT DICLOFENAC 1.16%W/W DAWA PHARMACEUTICALS KENYA TOPICAL 1.0X20.0 7/1/2013
DP/1111 LIMITED LTD GEL DIETHYLAMIN + 10%W/W LIMITED-PLOT 7879, BABA EXTERNAL G TUBE
E + METHYL + 3%W/W DOGO ROAD RUARAKA GELS AND
SALICYLATE + + 5%W/W SOLS
LINSEED OIL +
MENTHOL
CRYSTALS
584 NDA/MAL/H AUROBINDO GITTOES ZIDOVUDIN ZIDOVUDINE 100MG AUROBINDO PHARMA LTD INDIA ORAL SOLID 1.0X100.0 7/1/2008
DP/1112 PHARMA LTD PHARMACEUTIC E CAPSULES .-UNIT III SURVEY NO.313 ORDINARY CAPSULE
ALS LIMITED BACHU CAPSULES CONTAIN
ER
585 NDA/MAL/H MACK SHURIK LTD ALCID- MULTI- MULTI- TORQUE INDIA ORAL LIQUID 1.0X400.0 7/1/1997
DP/1113 BROWN YELLOW INGREDIENT INGREDIEN PHARMACEUTICALS PVT ORDINARY ML
PHARMECEUT T LTD-ISAAPUR P.O DAPPAR SUSPENSION BOTTLE,1.
ICALS PVT LTD 140056 INDIA S 0X160.0
ML
BOTTLE
586 NDA/MAL/H SHOSAAN RENE TRANGEL DICLOFENAC/ 10MG/80 NEM LABORATORIES INDIA TOPICAL 1.0X20.0 7/1/2012
DP/1114 ASIC PACIFIC PHARMACY LTD ULTRA METHYL MG/60MG LIMITED-133 KRISHNA EXTERNAL G
SALICYLATE/ /0.15MG IND. ESTATE, VASAI (E), GELS AND CONTAIN
MENTHOL/CA THANE – 401 210, SOLS ER
PSICUM MAHARASHTRA – INDIA
OLEORESIN
587 NDA/MAL/H SHOSAAN RENE TETRACYCLI TETRACYCLIN 1%W/W NEM LABORATORIES INDIA OPHTHALMI 1.0X20.0X 7/1/2013
DP/1117 ASIC PACIFIC PHARMACY LTD NE EYE E LIMITED-133 KRISHNA C 3.5 G
OINTMENT IND. ESTATE, VASAI (E), OINTMENTS TUBE
USP 1% THANE – 401 210,
MAHARASHTRA – INDIA
588 NDA/MAL/H ABACUS ABACUS ABCHLOR CHLORAMPH 5%W/V ABACUS PARENTERAL UGANDA OTIC DROPS 1.0X10.0 7/1/2013
DP/1122 PARENTERAL PARENTERAL EAR DROPS ENICOL DRUGS LIMITED-BLOCK ML
DRUGS DRUGS LIMITED 191, PLOT NO. 114, VIAL,1.0X
LIMITED GWAWANYA KINGA AND 5.0 ML
KAPEKA MUKONO VIAL
DISTRICT, UGANDA.
589 NDA/MAL/H GITTOES GITTOES AGOPAR PARACETAM 500 MG AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1.0X10.0X 7/1/2012
DP/1123 PHARMACEUT PHARMACEUTIC OL NO. 33, SECTOR II, VASAI, ORDINARY 10.0
ICALS LIMITED ALS LIMITED TALUKA INDL. TABLETS TABLET
BLISTER,1.
0X100.0
TABLET
CONTAIN
ER
590 NDA/MAL/H GITTOES GITTOES AGO SCRUB CHLORHEXIDI 4%W/V AGOG PHARMA LTD-PLOT INDIA TOPICAL 1.0X1.0X5 7/1/2013
DP/1124 PHARMACEUT PHARMACEUTIC NE NO.33,SECTOR EXTERNAL 00.0 ML
ICALS LIMITED ALS LIMITED GLUCONATE II,VASAI,TALUKA INDL CO- LIQUIDS BOTTLE
E INDIA
591 NDA/MAL/H AUROBINDO PHILLIPS AUROXONE CEFTRIAXONE 1000MG AUROBINDO PHARMA INDIA PARENTERAL 1.0X1.0 G 7/1/2009
DP/1125 PHARMA PHARMACEUTIC 1000 LIMITED, FORMULATIONS ORDINARY VIAL
LIMITED ALS (UGANDA) UNIT-VI- R7-AUROBINDO DRY VIALS
LIMITED PHARMA LIMITED,
FORMULATIONS UNIT-VI
SY.NO.329/39 & 329/47
CHITKUL(V) PATANCHERU
MANDAL, SANGA REDDY
DISTTELANGANA502307
592 NDA/MAL/H FEROZSONS HARLEYS CLARION CLARITHROM 500MG FEROZSONS PAKISTAN ORAL SOLID 1.0X10.0 7/1/2014
DP/1127 LABORATORIE UGANDA TABLETS YCIN LABORATORIES LTD- ORDINARY TABLET
S LTD LIMITED 500MG AMANGARH-NOWSHERA, FILM- BLISTER
(KHYBER COATED
TABLETS
PAKHTOONKHWA),
PAKISTAN
593 NDA/MAL/H LINCOLN METRO BTC KIT FLUCONAZOL 150MG + LINCOLN INDIA ORAL SOLID 1.0X4.0 7/1/2013
DP/1128 PHARMACEUT PHARMACEUTIC E+ 1G + 1G PHARMACEUTICALS L.T.D- ORDINARY TABLET
ICALS LTD ALS LIMITED AZITHROMYCI TRIMUL ESTATE KHATRAJ COMBINATI BLISTER
N+ 382721 GHANDINAGAR ON PACK
SECNIDAZOLE GUJARAT TABLETS
594 NDA/MAL/H LINCOLN METRO KLARO-500 CLARITHROM 500MG LINCOLN INDIA ORAL SOLID 1.0X10.0X 7/1/2012
DP/1130 PHARMACEUT PHARMACEUTIC YCIN TABLETS PHARMACEUTICALS ORDINARY 1.0X10.0
ICALS LTD ALS LIMITED LIMITED-10, 12, 13, TABLETS TABLET
TRIMUL ESTATE, AFTER BLISTER
KHATRAJ CHOKADI,
KHATRAJ-382721,
GHANDHINAGAR,
GUJARAT, INDIA
595 NDA/MAL/H FEROZSONS HARLEYS XAVOR 50 LOSARTAN 50MG FEROZSONS PAKISTAN ORAL SOLID 1.0X1.0X1 7/1/2014
DP/1131 LABORATORIE UGANDA LABORATORIES LTD- ORDINARY 0.0
S LTD LIMITED AMANGARH-NOWSHERA, FILM- TABLET
(KHYBER COATED BLISTER
TABLETS
PAKHTOONKHWA),
PAKISTAN
596 NDA/MAL/H STEDMAN VEERAM M-CALZ CALCIUM 1000MG+1 STEDMAN INDIA ORAL SOLID 1.0X3.0X1 7/1/2012
DP/1132 PHARMACEUT HEALTHCARE CITRATE 00MG+4M PHARMACEUTICALS PVT ORDINARY 0.0
ICALS PVT. (U) LIMITED +MAGNESIU G+200.I.U LIMITED-NO. C-4, SIDCO TABLETS TABLET
LTD M PHARMACEUTICAL STRIP
HYDROXIDE + COMPLEX, ALATHUR,
ZINC THIRUPORUR,
SULPHATE + KANCHEEPURAM DIST 603
COLECALCIFE 110, TAMILNADU, INDIA
ROL
597 NDA/MAL/H MEDIPHARM MEDIPHARM MEDICOL CHLORAMPH 125MG/5 MEDIPHARM INDUSTRIES UGANDA ORAL LIQUID 1.0X100.0 7/1/2007
DP/1133 SALES INDUSTRIES SUSPENSIO ENICOL ML (E.A) LTD-PLOT 65, ORDINARY ML
LIMITED (E.A) LTD N KAKAJJO ROAD, SUSPENSION BOTTLE
BWEYOGERERE S
598 NDA/MAL/H FEROZSONS HARLEYS XAVOR DIU LOSARTAN 50/12.5MG FEROZSONS PAKISTAN ORAL SOLID 1.0X1.0X1 7/1/2013
DP/1134 LABORATORIE UGANDA AND LABORATORIES LTD- ORDINARY 0.0
S LTD LIMITED HYDROCHLOR AMANGARH-NOWSHERA, FILM- TABLET
THIAZIDE (KHYBER COATED BLISTER
TABLETS
PAKHTOONKHWA),
PAKISTAN
599 NDA/MAL/H GITTOES GITTOES AGOSCAB BENZYL 25%W/W AGOG PHARMA LTD-PLOT INDIA TOPICAL 1.0X1.0X1 7/1/2013
DP/1136 PHARMACEUT PHARMACEUTIC APPLICATIO BENZOATE NO. 33, SECTOR II, VASAI, EXTERNAL 00.0 ML
ICALS LIMITED ALS LIMITED N TALUKA INDL. EMULSIONS BOTTLE
600 NDA/MAL/H GITTOES GITTOES AGO- CALAMINE 15%W/W AGOG PHARMA LTD-PLOT INDIA TOPICAL 1.0X1.0X1 7/1/2013
DP/1138 PHARMACEUT PHARMACEUTIC CALAMINE NO.33,SECTOR EXTERNAL 00.0 ML
ICALS LIMITED ALS LIMITED II,VASAI,TALUKA INDL CO- LOTIONS BOTTLE,1.
OP ESTATE LTD,GAURAI 0X60.0 ML
PADA,VASAI(E)DIST.THAN BOTTLE
E INDIA
601 NDA/MAL/H GITTOES GITTOES AGOVATE BETAMETHAS 0.1%W/W AGOG PHARMA LTD-PLOT INDIA TOPICAL 1.0X15.0 7/1/2013
DP/1139 PHARMACEUT PHARMACEUTIC ONE NO. 33, SECTOR II, VASAI, EXTERNAL G TUBE
ICALS LIMITED ALS LIMITED TALUKA INDL. CREAMS
602 NDA/MAL/H GITTOES GITTOES AGOVATE- BETAMETHAS 0.1%W/W+ AGOG PHARMA LTD-PLOT INDIA TOPICAL 1.0X15.0 7/1/2013
DP/1140 PHARMACEUT PHARMACEUTIC N ONE+NEOMY 0.5%W/W NO. 33, SECTOR II, VASAI, EXTERNAL G TUBE
ICALS LIMITED ALS LIMITED CIN TALUKA INDL. CREAMS
SULPHATE
603 NDA/MAL/H GITTOES GITTOES CANDIZOL CLOTRIMAZO 1%W/W AGOG PHARMA LTD-PLOT INDIA TOPICAL 1.0X20.0 7/1/2013
DP/1142 PHARMACEUT PHARMACEUTIC LE NO.33,SECTOR EXTERNAL G TUBE
ICALS LIMITED ALS LIMITED II,VASAI,TALUKA INDL CO- CREAMS
E INDIA
604 NDA/MAL/H LINCOLN METRO LOSA-H LOSARTAN + 50MG + LINCOLN INDIA ORAL SOLID 1.0X3.0X1 7/1/2012
DP/1143 P'CALS LTD PHARMACEUTIC HYDROCHLOR 12.5MG PHARMACEUTICALS ORDINARY 0.0
ALS LIMITED OTHIAZIDE LIMITED-10, 12, 13, FILM- TABLET
KHATRAJ CHOKADI,
KHATRAJ-382721,
GHANDHINAGAR,
GUJARAT, INDIA
605 NDA/MAL/H HILTON HEALTHCARE HILAC LACTULOSE 68%W/V HILTON PHARMA (PVT) PAKISTAN ORAL LIQUID 1.0X120.0 7/1/2005
DP/1145 PHARMA LTD. LTD-PLOT 13 SECTOR 15 ORDINARY ML
(PVT) LTD KORANGI INDUSTRIAL SYRUPS BOTTLE
AREA KARACHI
606 NDA/MAL/H CADILA ABACUS ODIMONT MONTELUKAS 10MG CADILA HEALTH CARE LTD- INDIA ORAL SOLID 1.0X10.0X 7/1/2012
DP/1148 HEALTHCARE PHARMA 10 T KUNDAIM INDUSTRIAL ORDINARY 10.0
LTD (AFRICA) ESTATE, PLOT NO. 203- COATED TABLET
LIMITED 213, KUNDAIM,GOA-403 TABLETS BLISTER
115, INDIA
607 NDA/MAL/H UNIVERSAL DELMAW NEUROBA GABAPENTIN 300MG UNIVERSAL CORPORATION KENYA ORAL SOLID 1.0X3.0X1 7/1/2015
DP/1149 CORPORATIO ENTERPRISES LTD..-PLOT 13777 CLUB ORDINARY 0.0
N LTD LIMITED ROAD, PAST KIKUYU CAPSULES CAPSULE
BLISTER
608 NDA/MAL/H AMANTA PHARMA VILLE FEBRAMOL PARACETAM 10MG/ML MARCK BIOSCIENCES - INDIA PARENTERAL 1.0X100.0 7/1/2013
DP/1150 HEALTHCARE LIMITED OL INFUSION PLOT NO 876, NH NO 8 ORDINARY ML
LTD HARIYALA KHEDA- 387411 INFUSION BOTTLE
GUJARAT, INDIA VIALS/BOTTL
ES
609 NDA/MAL/H SUN STAR BACQURE IMIPENEM + 500MG + SUN PHARMACEUTICAL INDIA PARENTERAL 1.0X30.0 7/1/2012
DP/1154 PHARMACEUT PHARMACEUTIC CILASTATIN 500MG INDUSTRIES LIMITED- ORDINARY ML VIAL
ICAL ALS LTD INDUSTRIAL AREA NO.3, DRY VIALS
INDUSTRIES A.B. ROAD DEWAS,
LIMITED 455001 (MP), INDIA.
610 NDA/MAL/H CIPLA LTD QUALITY FUNGICIP CLOTRIMAZO 1%W/W CIPLA LTD ----L139 TO L- INDIA TOPICAL 1.0X20.0 7/1/2011
DP/1156 CHEMICALS LTD - LE 146 VERNA INDUSTRIAL EXTERNAL G TUBE
HUMAN ESTATE VERNA SALCETTE CREAMS
GOA 403 722
611 NDA/MAL/H TRIVENI AIVEEN (U) TRAMADOL TRAMADOL 50MG TRIVENI FORMULATIONS INDIA ORAL SOLID 1.0X10.0X 7/1/2012
DP/1158 FORMULATIO LIMITED LTD .-PLOT NO. 52, 53,54 ORDINARY 10.0
NS LIMITED ALEAP INDUSTRIAL CAPSULES CAPSULE
ESTATE SURAMPALLI BLISTER
VILLAGE GANNAVARAM
MANDAL KRISHNA (DT)
A.P
612 NDA/MAL/H SHOSAAN RENE FRUSEMIDE FUROSEMIDE 40MG NEM LABORATORIES INDIA ORAL SOLID 1.0X10.0X 7/1/2013
DP/1163 ASIC PACIFIC PHARMACY LTD LIMITED-133 KRISHNA ORDINARY 10.0
IND. ESTATE, VASAI (E), TABLETS TABLET
THANE – 401 210, BLISTER,1.
MAHARASHTRA – INDIA 0X1000.0
TABLET
CONTAIN
ER
613 NDA/MAL/H TRIVENI AIVEEN (U) PIROXICAM PIROXICAM 20MG TRIVENI FORMULATIONS INDIA ORAL SOLID 1.0X10.0X 7/1/2013
DP/1164 FORMULATIO LIMITED LTD .-PLOT NO. 52, 53,54 ORDINARY 10.0
NS LIMITED ALEAP INDUSTRIAL CAPSULES CAPSULE
ESTATE SURAMPALLI BLISTER
VILLAGE GANNAVARAM
MANDAL KRISHNA (DT)
A.P
614 NDA/MAL/H PANACEA VITACARE DOLZERO TRAMADOL 37.5MG + PANACEA BIOTEC LTD- INDIA ORAL SOLID 1.0X10.0X 7/1/2013
DP/1166 BIOTEC LTD LIMITED HYDROCHLOR 325MG MALPUR, BADDI, TEHSIL, ORDINARY 10.0
IDE + NALAGARH, DIST. SOLAN TABLETS TABLET
PARACETAM (H.P) – 173 205 BLISTER
OL
615 NDA/MAL/H CIRON DRUGS RENE METOCLOP METOCLOPRA 5MG/ML CIRON DRUGS & INDIA PARENTERAL 1.0X10.0X 7/1/2010
DP/1167 AND PHARMACY LTD RAMIDE MIDE PHARMACEUTICALS PVT ORDINARY 10.0X2.0
PHARMACEUT INJECTION LTD .-N-118,M.I.D.C, AMPOULES ML
ICALS PVT LTD TARAPUR,BOISAR, AMPOULE
DIST.THANE-401506,
MAHARASHTRA,INDIA.
616 NDA/MAL/H DAWA SUPER MEDIC DAWA- HYDROCORTI 1%W/W DAWA LTD -BABA DOGO KENYA TOPICAL 1.0X15.0 7/1/2009
DP/1168 LIMITED LTD CORT SONE ROAD, RUARAKA P.O.BOX EXTERNAL G TUBE
CREAM 16633-00620, NAIROBI CREAMS
KENYA
617 NDA/MAL/H ARISTO NORVIK NEBI 5 NEBIVOLOL 5MG ARISTO INDIA ORAL SOLID 1.0X3.0X1 7/1/2013
DP/1169 PHARMACEUT ENTERPRISES HYDROCHLOR PHARMACEUTCALS PVT ORDINARY 0.0
ICALS PVT LTD LIMITED IDE LTD-PLOT NO.208 NEW TABLETS TABLET
INDUSTRIAL AREA NO.II BLISTER,1.
MANDIDEEP 462046 0X10.0X10
RAISEN MADHYA .0 TABLET
PRADESH BLISTER
618 NDA/MAL/H ARISTO NORVIK ARISTO METHYLCOBA 500MCG ARISTO INDIA PARENTERAL 1.0X1.0 7/1/2013
DP/1170 PHARMACEUT ENTERPRISES MEGANEUR LAMIN PHARMACEUTICALS PVT. ORDINARY I ML
ICALS PVT LTD LIMITED ON LIMITED-PLOT NO. 208, M AMPOULE
NEW INDUSTRIAL AREA AMPOULES
NO.II,MANDIDEEEP
PRADESH
619 NDA/MAL/H CIRON DRUGS RENE LIDOCAINE LIDOCAINE 20MG/ML CIRON DRUGS & INDIA PARENTERAL 1.0X20.0 7/1/2010
DP/1172 AND PHARMACY LTD HYDROCHL HYDROCHLOR PHARMACEUTICALS PVT ORDINARY ML
PHARMACEUT ORIDE IDE LTD .-N-118,M.I.D.C, VIALS VIAL,1.0X
ICALS PVT LTD TARAPUR,BOISAR, 30.0 ML
DIST.THANE-401506, VIAL
MAHARASHTRA,INDIA.
620 NDA/MAL/H HETERO AIVEEN (U) TENOFOVIR TENOFOVIR 300MG HETERO LABS LTD-22-110 INDIA ORAL SOLID 1.0X30.0 7/1/2013
DP/1178 DRUGS LTD LIMITED DISOPROXIL IDA JEEDIMETLA ORDINARY TABLET
FUMARATE HYDERABAD 500-055 TABLETS CONTAIN
ANDHRA PRADESH ER
621 NDA/MAL/H MERCK (PTY) UNITED OVITRELLE CHORIOGON 250MCG/0. MERCK SERONO SA-1170 SWITZERLAN PARENTERAL 1.0X1.0 7/1/2015
DP/1179 LTD HEALTHCARE ADOTROPIN 5ML AUBONNE(SWITZERLAND) D ORDINARY PREFILLED
DISTRIBUTORS ALFA MERCK SERONO S.P.A-VIA PRE-FILLED SYRINGE
LTD DELLE SYRINGES CARTON
MAGNOLIE,15.70026
MODUGNO (BA).ITALY
622 NDA/MAL/H TORRENT KARURI ASTHATOR MONTELUKAS 4 MG TORRENT INDIA ORAL SOLID 1.0X3.0X1 7/1/2013
DP/1181 PHARAMACE PHARMACEUTIC 4 T SODIUM PHARMACEUTICALS LTD .,- ORDINARY 0.0
UTICALS LTD ALS LTD. AHMEDABAD-MEHSANA TABLETS TABLET
382721, GUJARAT
623 NDA/MAL/H TORRENT KARURI ASTHATOR MONTELUKAS 5MG TORRENT INDIA ORAL SOLID 1.0X3.0X1 7/1/2013
DP/1182 PHARAMACE PHARMACEUTIC 5 T SODIUM PHARMACEUTICALS LTD .,- ORDINARY 0.0
382721, GUJARAT
624 NDA/MAL/H DAWA SUPER MEDIC DACOF SALBUTAMOL 2.0MG + DAWA LTD -PLOT KENYA ORAL LIQUID 1.0X100.0 7/1/2013
DP/1184 LIMITED LTD MUCOLYTIC + 4.0MG NO.7879/8 BABA ROAD ORDINARY ML
BROMHEXINE +100MG + RUARAKA NAIROBI SYRUPS BOTTLE
+ 1.0MG
GUAIPHENESI
N+
MENTHOL
625 NDA/MAL/H DAWA SUPER MEDIC DACOF DRY DIPHENHYDR 12.5MG + DAWA LTD -PLOT KENYA ORAL LIQUID 1.0X100.0 7/1/2013
DP/1185 LIMITED LTD AMINE + 6.5MG + NO.7879/8 BABA ROAD ORDINARY ML
DEXTROMET 1.10MG RUARAKA NAIROBI SYRUPS BOTTLE
HORPHAN +
MENTHOL
626 NDA/MAL/H DAWA SUPER MEDIC DACOF DIPHENHYDR 14.0MG + DAWA LTD -PLOT KENYA ORAL LIQUID 1.0X100.0 7/1/2013
DP/1186 LIMITED LTD EXPECTORA AMINE 135.0MG + NO.7879/8 BABA ROAD ORDINARY ML
NT HYDROCHLOR 57.0MG + RUARAKA NAIROBI SYRUPS BOTTLE
IDE + 1.10MG
AMMONIUM
CHLORIDE +
SODIUM
CITRATE +
MENTHOL
627 NDA/MAL/H GALPHA AIVEEN (U) KEFTAZ- CEFTAZIDIME 1 G ALKEM LABORATORIES INDIA PARENTERAL 1.0X1.0X1 7/1/2013
DP/1187 LABORATORIE LIMITED 1000 LTD-VILLAGE – THANA, ORDINARY .0 G VIAL
S LTD BADDI TEHSIL – DRY VIALS + 1*10 ML
NALAGARH, DIST-SOLAN WATER
(HP), INDIA – 173205 FOR
INJECTIO
N
628 NDA/MAL/H VENUS HARLEYS PISA PIPERACILLIN 4000MG/V VENUS REMEDIES LTD, INDIA PARENTERAL 1.0X1.0X3 7/1/2009
DP/1194 REMEDIES UGANDA + IAL + UNIT II,-HILL TOP ORDINARY 0.0 ML
LTD LIMITED TAZOBACTAM 500MG/VI INDUSTRIAL ESTATE, VIALS VIAL
AL JHARMAJTI, EPIP, PHASE-1
(EXTENSION), BHATOLI
KALAN, BADDI -HP
629 NDA/MAL/H UNIVERSAL HARLEYS ALTRINE CETIRIZINE 5MG/5ML UNIVERSAL CORPORATION KENYA ORAL LIQUID 1.0X60.0 7/1/2013
DP/1195 CORPORATIO UGANDA LIMITED -PLOT 13777 ORDINARY ML
N LTD LIMITED KIKUYU ROAD, KIKUYU SYRUPS BOTTLE,1.
TOWN, PAST POST OFFICE 0X30.0 ML
BOTTLE
630 NDA/MAL/H UNIVERSAL DELMAW ACNESOL TRETINOIN 0.05%W/W UNIVERSAL CORPORATION KENYA TOPICAL 1.0X25.0 7/1/2012
DP/1196 CORPORATIO ENTERPRISES LTD..-PLOT 13777 CLUB EXTERNAL G TUBE
N LTD LIMITED ROAD, PAST KIKUYU CREAMS
631 NDA/MAL/H MEDIPHARM MEDIPHARM QUINIMIX QUININE 100MG/5 MEDIPHARM INDUSTRIES UGANDA ORAL LIQUID 1.0X100.0 7/1/2003
DP/1202 SALES INDUSTRIES SYRUP HYDROCHLOR ML (E.A) LTD-PLOT 65, ORDINARY ML
LIMITED (E.A) LTD IDE KAKAJJO ROAD, SYRUPS BOTTLE
BWEYOGERERE
632 NDA/MAL/H MYLAN KIMSY MEDS EFAVIRENZ EFAVIRENZ 600MG MYLAN LABORATORIES INDIA ORAL SOLID 1.0X30.0 7/1/2008
DP/1205 LABORATORIE LTD LTD--F-4,F-12 MALEGAON ORDINARY TABLET
S LIMITED MIDC SINNAR NASHIK TABLETS CONTAIN
422113 MAHARASHTRA ER
STATE
MYLAN LABORATORIES
LTD -- PLOT NO. H-12 & H-
13 MIDCWALUJ
INDUSTRIAL AREA
AURANGABAD 431136
MAHARASTRA
633 NDA/MAL/H THE HARLEYS DEEP IBUPROFEN + 5%W/W + THE MENTHOLATUM CO. UNITED TOPICAL 1.0X50.0 7/1/2013
DP/1206 METHOLATU UGANDA RELIEF MENTHOL 3% W/W LTD. -1 REDWOOD AVE KINGDOM EXTERNAL G
M CO. LTD LIMITED PEEL PARK CAMPUS EAST OTHER CONTAIN
KILBRIDE GELS/SOLS ER,1.0X15
.0 G
CONTAIN
ER,1.0X30
.0 G
CONTAIN
ER
634 NDA/MAL/H ARISTO NORVIK VISCO ALGINIC ACID 100 MG + ARISTO INDIA ORAL LIQUID 1.0X1.0X2 7/1/2011
DP/1208 PHARMACEUT ENTERPRISES LIQUID + 250 MG + PHARMACEUTCALS PVT ORDINARY 00.0 ML
ICALS PVT LTD LIMITED MAGNESIUM 125 MG + LTD-PLOT NO.208 NEW SUSPENSION BOTTLE,1.
HYDROXIDE + 50 MG INDUSTRIAL AREA NO.II S 0X100.0
ALUMINIUM MANDIDEEP 462046 ML
HYDROXIDE + RAISEN MADHYA BOTTLE
SIMETHICONE PRADESH
635 NDA/MAL/H MICRO LABS PHILLIPS ARBITEL-80 TELMISARTA 80MG MICRO LABS LTD-92, INDIA ORAL SOLID 1.0X3.0X1 7/1/2011
DP/1209 LTD PHARMACEUTIC N SIPCOT INDUSTRIAL ORDINARY 0.0
636 NDA/MAL/H ASTRA MACNAUGHTON BRILINTA TICAGRELOR 90MG ASTRA ZENECA AB-SE-151 UNITED ORAL SOLID 1.0X4.0X1 7/1/2011
DP/1211 ZENECA LIMITED 85 SODERTALJE, SWEDEN KINGDOM ORDINARY 4.0
(GARTUNAVAGEN & TABLETS TABLET
SNACKVIKEN) BLISTER
637 NDA/MAL/H GUILIN STAR GLINTHER ARTEMETHER 80MG/ML GUILIN PHARMACEUTICAL CHINA PARENTERAL 1.0X6.0X1 7/1/2011
DP/1212 PHARMACEUT PHARMACEUTIC CO.,LTD-NO 43 QILIDIAN ORDINARY I .0 ML
ICALS CO.LTD ALS LTD ROAD GUILIN 541002, M AMPOULE
GUANGXI AMPOULES
638 NDA/MAL/H FERRER LABOREX NUCLEO CYTIDINE+URI 5MG+3MG FERRER INTERNACIONAL, SPAIN ORAL SOLID 1.0X2.0X1 7/1/2013
DP/1214 INTERNACION UGANDA C.M.P DINE S.A-JOAN BUCSALA 1-9, ORDINARY 5.0
AL S.A LIMITED FORTE 08173 SANT CUGAT DEL CAPSULES CAPSULE
VALLES, BARCELONA, BLISTER
SPAIN
639 NDA/MAL/H SANOFI SURGIPHARM INSUMAN RECOMBINAN 100 IU/ML SANOFI-AVENTIS GERMANY PARENTERAL 1.0X5.0X3 7/1/2014
DP/1217 AVENTIS (U) LIMITED BASAL T HUMAN DEUTSCHLAND GMBH - ORDINARY .0 ML
INSULIN INDUSTRIEPARK HOECHST, VIALS CARTRIDG
BRUNINGSTRASSEN, E,1.0X5.0
BUILDING ML VIAL
AM MAIN, GERMANY
640 NDA/MAL/H DENK BENLE CONSULT TORAS- TORASEMIDE 5MG DENK PHARMA GMBH GERMANY ORAL SOLID 1.0X3.0X1 7/1/2014
DP/1219 PHARMA LIMITED DENK 5 &CO.KG-- ORDINARY 0.0
GMBH & CO PRINZREGENTESTR.79.816 TABLETS TABLET
KG 75 MUENCHEN, BLISTER
845529 TITTMONING
GERMANY
641 NDA/MAL/H REGAL REGAL PHARMA WHITFIELD' BENZOIC 6%W/W + REGAL KENYA TOPICAL 1.0X1.0X2 7/1/1997
DP/1223 PHARMACEUI (U) LTD S ACID + 3%W/W PHARMACEUTICALS LTD- EXTERNAL 5.0 G
CALS LTD OINTMENT SALICYLIC BABA DOGO ROAD, OINTMENTS TUBE
ACID RAURAKA,NAIROBI,KENYA
642 NDA/MAL/H KOTRAPHAR ABACUS VAXCEL CEFTRIAXONE 1G KOTRA PHARMA SDN BDN- MALAYSIA PARENTERAL 1.0X1.0 G 7/1/2013
DP/1224 MA (M) PHARMA CEFTRIAXO 1, 2, &3, JALANTTC12 ORDINARY VIAL
SDN.BHD (AFRICA) NE CHENG INDUSTRIAL DRY VIALS
LIMITED ESTATE, 75250, MELAKA,
MALAYSIA
643 NDA/MAL/H AFRICURE ROYAL PHARMA SALBUTAM SALBUTAMOL 4MG AFRICURE INDIA ORAL SOLID 1.0X100.0 7/1/2005
DP/1226 PHARMACEUT 2011 LIMITED OL PHARMACEUTICALS ORDINARY TABLET
ICALS (INDIA) (INDIA) PRIVATE LIMITED TABLETS CONTAIN
LTD (755793)-PLOT 9- ER,1.0X10
12,DEWAN & SONS 00.0
INDUSTRIAL. AREA, TABLET
VEOOR,PALGHAR-401404. CONTAIN
INDIA. ER,10.0X1
0.0
TABLET
BLISTER
644 NDA/MAL/H AMOUN BOOTS FUNGISAFE TERBINAFINE 250MG AMOUN EGYPT ORAL SOLID 1.0X7.0 7/1/2013
DP/1227 PHARMACEUT PHARMACEUTIC HCL PHARMACEUTICAL CO. ORDINARY TABLET
ICALS ALS LIMITED S.A.E-1ST INDUSTRIAL FILM- STRIP
COMPANY ZONE A, PLOTS NO. COATED
1B,2,3,4,5 BLOCK 13015, TABLETS
EL-OBOUR CITY,
KALYOUBIA CAIRO
EGYPT
645 NDA/MAL/H ASTRA ASTRA PHARMA LUMETHER ARTEMETHER 20 MG + ASTRA LIFECARE (INDIA) INDIA ORAL SOLID 1.0X4.0X6 7/1/2010
DP/1228 LIFECARE (U) LIMITED + 120 MG PVT. LTD-PLOT 57/P, ORDINARY .0 TABLET
(INDIA) PVT. LUMEFANTRI SARKHEJ-BAVLA TABLETS BLISTER
LTD NE HIGHWAY, RAJODA 382
646 NDA/MAL/H MARCK PHARMA VILLE LIDOCAINE LIDOCAINE 2%W/V MARCK BIOSCIENCES INDIA PARENTERAL 1.0X10.0 7/1/2012
DP/1229 BIOSCIENCES LIMITED LIMITED-PLOT NO 876, NH ORDINARY ML VIAL
LIMITED NO 8 HARIYALA KHEDA- VIALS
387411 GUJARAT, INDIA
647 NDA/MAL/H MEDOPHARM PLANET LOXAMP AMPICILLIN + 250 MG + MEDOPHARM PVT LTD.- INDIA ORAL SOLID 1.0X10.0X 7/1/2013
DP/1230 PRIVATE PHARMACEUTIC CLOXACILLIN 250 MG NO. 50 KAYARAMBEDU ORDINARY 10.0
LIMITED ALS UGANDA VILLAGE GUDUVANCHERY CAPSULES CAPSULE
LTD 603 203 CHENGALPET BLISTER
DISTRICT TAMIL NADU
648 NDA/MAL/H BETA BETA SEPTRIN CO- DRAXIS PHARMA INC.- CANADA PARENTERAL 1.0X10.0X 7/1/1997
DP/1238 HEALTHCARE HEALTHCARE INJECTION TRIMOXAZOL 480MG/5 QUEBEC, CANADA ORDINARY 5.0 ML
UGANDA UGANDA E ML AMPOULES AMPOULE
LIMITED LIMITED
649 NDA/MAL/H GITTOES GITTOES TOPHEN- PHENYTOIN 100MG AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1.0X10.0X 7/1/2013
DP/1242 PHARMACEUT PHARMACEUTIC 100 NO. 33, SECTOR II, VASAI, ORDINARY 10.0
COATED BLISTER,1.
TABLETS 0X1000.0
TABLET
CONTAIN
ER
650 NDA/MAL/H DENK BENLE CONSULT LEVO DENK LEVOFLOXACI 250MG ROTTENDORF PHARMA GERMANY ORAL SOLID 1.0X10.0 7/1/2014
DP/1243 PHARMA LIMITED 250 N GMBH-OSTENFELDER ORDINARY TABLET
GMBH & CO HEMIHYDRAT STRASSE 51-61 59320 FILM- BLISTER
KG E ENNIGERLOH GERMANY COATED
TABLETS
651 NDA/MAL/H GITTOES GITTOES PROCIP CYPROHEPTA 4MG AGOG PHARMA LTD.-PLOT INDIA ORAL SOLID 1.0X2.0X5 7/1/2012
DP/1247 PHARMACEUT PHARMACEUTIC DINE NO. 33, SECTOR II, VASAI, ORDINARY .0X10.0
BLISTER
652 NDA/MAL/H MACK SHURIK LTD ZOY SILDENAFIL 50MG TORQUE INDIA ORAL SOLID 1.0X1.0X4 7/1/2013
DP/1252 BROWN PHAMACEAUTICALS PVT ORDINARY .0 TABLET
PHARMECEUT LTD-VILL ISSAPUR P.O TABLETS BLISTER
ICALS PVT LTD DAPPAR INDIA
653 NDA/MAL/H COSMOS LTD ASTRA PHARMA COSATRIM CO- 480MG COSMOS LIMITED-- KENYA ORAL SOLID 1.0X1000. 7/1/1998
DP/1254 (U) LIMITED TABLETS TRIMOXAZOL RANGWA ROAD, OFF ORDINARY 0 TABLET
E LUNGA LUNGA ROAD,P.O TABLETS CONTAIN
BOX 414 33, NAIORBI ER,1.0X10
INDUSTRIAL AREA 0.0
TABLET
CONTAIN
ER
654 NDA/MAL/H CIPLA LTD QUALITY NIFELAT NIFEDIPINE 20MG CIPLA LTD-MIDC INDIA ORAL SOLID 1.0X10.0X 7/1/1997
DP/1255 CHEMICALS LTD - RETARD PATALGANGA 410 220 RETARD 10.0
HUMAN DIST. RAIGAD TABLETS TABLET
BLISTER
655 NDA/MAL/H SIRMAXO KIMSY MEDS SANIQUAD POVIDONE 10%W/W SIRMAXO CHEMICALS PVT INDIA TOPICAL 1.0X100.0 7/1/2015
DP/1256 CHEMICALS LTD PVP T IODINE LTD-PLOT NO. E-35. EXTERNAL ML
PVT LTD TARAPRU MIDC BOISAR, LIQUIDS BOTTLE,1.
THANE, MUMBAI, INDIA 0X200.0
ML
BOTTLE,1.
0X500.0
ML
BOTTLE,1.
0X1000.0
ML
BOTTLE
656 NDA/MAL/H IPCA MEDVIN CARDOZ- CARVEDILOL 6.25MG IPCA LABORATORIES LTD- INDIA ORAL SOLID 1.0X2.0X1 7/1/2013
DP/1259 LABORATORIE PHARMA 6.25 PLOT NO. 255/1, ORDINARY 4.0
S LTD LIMITED VILLAGE ATHAL, TABLETS TABLET
SILVASSA-396230, BLISTER
DADRA AND NAGAR
HAVELI, INDIA.
657 NDA/MAL/H IPCA MEDVIN CARDOZ- CARVEDILOL 12.5MG IPCA LABORATORIES LTD- INDIA ORAL SOLID 1.0X2.0X1 7/1/2013
DP/1261 LABORATORIE PHARMA 12.5 PLOT NO. 255/1, ORDINARY 4.0
S LTD LIMITED VILLAGE ATHAL, TABLETS TABLET
DADRA AND NAGAR
HAVELI, INDIA.
658 NDA/MAL/H CENTAUR GITTOES OCUCYCLIN TETRACYCLIN 1%W/W CENTAUR INDIA OPHTHALMI 1.0X5.0 G 7/1/2000
DP/1264 PHARMACEUT PHARMACEUTIC E EYE E PHARMACEUTICALS PVT C TUBE,1.0X
ICALS ALS LIMITED OINTMENT HYDROCHLOR LTD --PLANT II PLOT 39-41 OINTMENTS 3.5 G
PRIVATE IDE TIVIM INDUSTRIAL ESTATE TUBE
LIMITED KARASWADA MAPUSA
GOA 403 526
659 NDA/MAL/H GITTOES GITTOES COMBIPLEX VITAMIN B1 + 1.0 MG + AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1.0X1000. 7/1/2008
DP/1265 PHARMACEUT PHARMACEUTIC VITAMIN B2 + 1.0 MG + NO.33,SECTOR ORDINARY 0 TABLET
ICALS LIMITED ALS LIMITED NICOTINAMI 15 MG + II,VASAI,TALUKA INDL CO- COATED CONTAIN
DE + VITAMIN 0.5 MG OP ESTATE LTD,GAURAI TABLETS ER,1.0X10
B6 PADA,VASAI(E)DIST.THAN .0X10.0
E INDIA TABLET
BLISTER
660 NDA/MAL/H SURGE LAB JEET ROMYCIN AZITHROMYCI 250MG NABIQASIM INDUSTRIES PAKISTAN ORAL SOLID 1.0X1.0X6 7/1/2007
DP/1274 (PVT) LIMITED PHARMACEUTIC N (PVT) LTD-- ORDINARY .0
ALS LIMITED 17/24,KORANGI CAPSULES CAPSULE
INDUSTRIAL AREA, BLISTER
KORANGI, KARACHI-
PAKISTAN.
661 NDA/MAL/H REMEDICA GOODMAN NIFELAT 10 NIFEDIPINE 10MG REMEDICA LIMITED - CYPRUS ORAL SOLID 1.0X10.0X 7/1/1997
DP/1275 LTD INTERNATIONAL F.C AHARNON STREET, ORDINARY 10.0
LTD TABLETS LIMASSOL INDUSTRIAL FILM- TABLET
ESTATE. LIMASSOL, COATED BLISTER
CYPRUS 3056, CYPRUS TABLETS
662 NDA/MAL/H INCEPTA ECHO PANTONIX PANTOPRAZO 40MG INCEPTA BANGLADESH PARENTERAL 1.0X1.0X4 7/1/2013
DP/1276 PHARMACUTI PHARMACY (U) 40 LE SODIUM PHARMACEUTICALS ORDINARY 0.0 MG
CALS LIMITED LIMITED INJECTION SEQUIHYDRA LIMITED-DEWAN IDRIS AMPOULES VIAL
TE ROAD, BARA 1*10ML
RANGAMATIA, ZIRABO AMPOULE
SAVAR, DHAKA, OF 0.9%
BANGLADESH NACL
663 NDA/MAL/H SANOTI SURGIPHARM INSUMAN INSULIN 100 IU/ML SANOFI-AVENTIS GERMANY PARENTERAL 1.0X5.0 7/1/2015
DP/1277 AVENTIS (U) LIMITED RAPID HUMAN DEUTSCHLAND GMBH- ORDINARY S ML VIAL
INDUSTRIEPARK HOECHST, C VIALS
BRUNINGSTRASSEN,
BUILDING D-65926
FRANKFURT AM MAIN,
GERMANY
664 NDA/MAL/H GUILIN STAR D-ARTEPP DIHYDROART 40MG GUILIN PHARMACEUTICAL CHINA ORAL SOLID 1.0X9.0 7/1/2013
DP/1278 PHARMACEUT PHARMACEUTIC EMESININ + +320MG CO LTD-NO.43 QILIDIAN ORDINARY TABLET
ICALS CO.LTD ALS LTD PIPERAQUINE ROAD GUILIN 541004 TABLETS BLISTER,1.
PHOSPHATE GUANGXI 0X8.0
TABLET
BLISTER,1.
0X25.0X1.
0X9.0
TABLET
BLISTER
665 NDA/MAL/H ZEE ZEE LOSABERG LOSARTAN 50MG THE MADRAS INDIA ORAL SOLID 1.0X10.0X 7/1/2016
DP/1282 PHARMACEUT PHARMACEUTIC POTASSIUM PHARMACEUTICALS..-NO. ORDINARY 10.0
ICALS LTD ALS LIMITED 137B, OLD FILM- TABLET
MAHABALIPURAM ROAD, COATED BLISTER
KARAPAKKAM, CHENNAI TABLETS
600096
666 NDA/MAL/H SANCE DELMAW SANIX- DS CEFIXIME 100MG/5 SANCE LABORATORIES INDIA ORAL LIQUID 1.0X100.0 7/1/2014
DP/1287 LABORATORIE ENTERPRISES 100 ML PRIVATE LTD-PB NO. 2 ORDINARY ML
S PVT LTD LIMITED ELAPPUNKAL JN, DRY BOTTLE,1.
KOOZLUVANAL , 686 523, SUSPENSION 0X60.0 ML
PALA, KOTTAYAM S/SYRUPS/D BOTTLE
DISTRICT, KERALA, INDIA. ROPS
667 NDA/MAL/H PHARCO WIDE VITAMINAT VITAMIN B MULT- PHARCO EGYPT ORAL LIQUID 1.0120.0 7/1/1998
DP/1288 PHARMACEUT SPECTRUM SYRUP COMPLEX INGREDIEN PHARMACEUTICALS LTD- ORDINARY ML
ICALS ENTERPRISES T KILO 31 ALEXANDRIA, SYRUPS BOTTLE
(U) LIMITED CAIRO DESERT ROAD,
ALEXANDRIA EGYPT
668 NDA/MAL/H SANCE DELMAW SANIX 400 CEFIXIME 400MG SANCE LABORATORIES INDIA ORAL SOLID 1.0X10.0X 7/1/2013
DP/1290 LABORATORIE ENTERPRISES CAP PRIVATE LTD-PB NO. 2 ORDINARY 10.0
S PVT LTD LIMITED ELAPPUNKAL JN, CAPSULES CAPSULE
KOOZLUVANAL , 686 523, BLISTER
PALA, KOTTAYAM
DISTRICT, KERALA, INDIA.
669 NDA/MAL/H BAYER SURGIPHARM ULTRAVIST- IOPROMIDE 300MG/ML BAYER PHARMA A.G- GERMANY PARENTERAL 1.0X50.0 7/1/2012
DP/1291 SCHERING (U) LIMITED 300 MULLERSTRASSE 178, ORDINARY ML
PHARMA 13353 BERLIN, GERMANY VIALS VIAL,1.0X
100.0 ML
VIAL
670 NDA/MAL/H ZEE ZEE ZEEGRA - SILDENAFIL 100MG THE MADRAS INDIA ORAL SOLID 1.0X4.0 7/1/2016
DP/1293 PHARMACEUT PHARMACEUTIC 100 CITRATE PHARMACEUTICALS..-NO. ORDINARY TABLET
ICALS LTD ALS LIMITED 137B, OLD FILM- BLISTER
MAHABALIPURAM ROAD, COATED
KARAPAKKAM, CHENNAI TABLETS
600096
671 NDA/MAL/H BAYER SURGIPHARM ULTRAVIST IOPROMIDE 370MG/ML BAYER PHARMA A.G- GERMANY PARENTERAL 1.0X100.0 7/1/2012
DP/1294 SCHERING (U) LIMITED 370 MULLERSTRASSE 178, ORDINARY ML
PHARMA 13353 BERLIN, GERMANY VIALS VIAL,1.0X
50.0 ML
VIAL
672 NDA/MAL/H SHAIGAN HEALTHCARE ZEPAR ALBENDAZOL 200MG SHAIGAN PAKISTAN ORAL SOLID 1.0X2.0 7/1/1997
DP/1295 PHARMACEUT LTD. E PHARMACEUTICALS (PVT) ORDINARY TABLET
ICALS (PVT) LTD-14TH KM, ADYALA TABLETS BLISTER
LTD ROAD, RAWALPINDI-
PAKISTAN
673 NDA/MAL/H HOVID BHD UNITED NEUROVIT THIAMINE 245.5MG/ HOVID BHD (IPOH SITE)- MALAYSIA ORAL SOLID 1.0X10.0X 7/1/2013
DP/1298 HEALTHCARE FORTE MONONITRA 250MG/ 121 ,JALAN TUNKU ABDUL ORDINARY 10.0
DISTRIBUTORS TE/ 1.4MG RAHMAN , 30010 IPOH , FILM- TABLET
LTD PYRIDOXINE/ PERAK , MALAYSIA COATED BLISTER
CYANOCOBAL TABLETS
AMIN
674 NDA/MAL/H SANCE DELMAW SANAXONE CEFTRIAXONE 1000MG+5 SANCE LABORATORIES INDIA PARENTERAL 1.0X1.5 G 7/1/2012
DP/1299 LABORATORIE ENTERPRISES PLUS-1000 +SULBACTAM 00MG PRIVATE LTD-PB NO. 2 ORDINARY VIAL,1.0X
S PVT LTD LIMITED ELAPPUNKAL JN, DRY VIALS 50.0X1.0
KOOZLUVANAL , 686 523, VIAL
PALA, KOTTAYAM CARTON
DISTRICT, KERALA, INDIA.
675 NDA/MAL/H KOPRAN TATA UGANDA ATENOLOL- ATENOLOL 100MG KOPRAN LIMITED-VILLAGE- INDIA ORAL SOLID 1.0X16.0X 7/1/1997
DP/1300 LIMITED LIMITED 100 SAVROLI (KHOPOLI), ORDINARY 14.0
TALUKA- KHALAPUR, DIST. FILM- TABLET
RAIGAD, MAHARASHTRA, COATED BLISTER
INDIA TABLETS
676 NDA/MAL/H HOVID BHD UNITED COSAMINE GLUCOSAMIN 250MG + HOVID BERHAD (CHEMOR MALAYSIA ORAL SOLID 1.0X10.0X 7/1/2013
DP/1301 HEALTHCARE PLUS E SULPHATE + 200MG SITE)--LOT 56442, 71/2, ORDINARY 10.0
DISTRIBUTORS CHONDROITI JALAN IPOH/CHEMOR TABLETS TABLET
LTD N SULPHATE 31200, PERAK. MALAYSIA BLISTER
677 NDA/MAL/H CADILA ABACUS HIPEN AMOXYCILLIN 250MG SPARSH BIO-TECH PVT. INDIA ORAL SOLID 1.0X1000. 7/1/1997
DP/1302 HEALTHCARE PHARMA CAPSULES LIMITED-PLOT NO. ORDINARY 0
LTD (AFRICA) 1;SURVEY NO. CAPSULES CAPSULE
LIMITED 242/243/244,LAKHABAVA CONTAIN
D,JAMNAGAR-361 006, ER,1.0X10
INDIA. .0X10.0
CAPSULE
BLISTER
678 NDA/MAL/H MICRO LABS PHILLIPS DIAPRIDE GLIMEPIRIDE 1MG + MICRO LABS LTD--NO 92, INDIA ORAL SOLID 1.0X3.0X1 7/1/2012
DP/1304 LTD PHARMACEUTIC PLUS 2 + 500MG SIPCOT, HOSUR-635 126,, ORDINARY 0.0
ALS (UGANDA) METFORMIN TAMIL NADU, INDIA FILM- TABLET
TABLETS
679 NDA/MAL/H MICRO LABS PHILLIPS ARBITEL 40 TELMISARTA 40MG MICRO LABS LTD ..-57, INDIA ORAL SOLID 1.0X3.0X1 7/1/2013
DP/1307 LTD PHARMACEUTIC N SIPCOT INDUSTRIAL ORDINARY 0.0
ALS (UGANDA) COMPLEX, HOSUR-635126, TABLETS TABLET
LIMITED TAMIIL NADU BLISTER
680 NDA/MAL/H REMEDICA GOODMAN ZESTAVAL ALBENDAZOL 200MG REMEDICA LTD-AHARNON CYPRUS ORAL SOLID 50.0X2.0 7/1/1997
DP/1319 LTD INTERNATIONAL 200 F.C E STREET, LIMASSOL ORDINARY TABLET
LTD TABLETS INDUSTRIAL ESTATE, 3056 FILM- BLISTER,1.
LIMASSOL COATED 0X2.0
TABLETS TABLET
BLISTER
681 NDA/MAL/H MACK SHURIK LTD TOOTH MULTI MULTI TORQUE INDIA ORAL LIQUID 1.0X1.0X1 7/1/2005
DP/1324 BROWN HEAL INGREDIENT INGREDIEN PHARMACEUTICALS LTD - ORDINARY 8.0 ML
PHARMECEUT T ISSAPUR P.O DAPPAR LIQUIDS BOTTLE
ICALS PVT LTD 140506
682 NDA/MAL/H GLAXOSMITH UNITED ENGERIX-B HEPATITIS B 20MCG/ML GLAXOSMITHKLINE BELGIUM PARENTERAL 1.0X10.0X 7/1/1997
DP/1328 KLINE HEALTHCARE VACCINE SURFACE BOILOGICALS-S.A RUE DE ORDINARY 1.0 ML
PHARMACEUT DISTRIBUTORS ANTIGEN I'INSTITUT 89 B-1330 VIALS VIAL (1
ICAL KENYA LTD RIXENSART DOSE),1.0
LTD X25.0X1.0
ML VIAL
(1 DOSE)
683 NDA/MAL/H IPCA MEDVIN RAPICLAV- AMOXYCILLIN 500MG+12 IPCA LABORATORIES LTD,.- INDIA ORAL SOLID 1.0X5.0X2 7/1/2003
DP/1330 LABORATORIE PHARMA 625 +CLAVULANIC 5MG PLOT 69 TO 72 (B), ORDINARY .0 TABLET
S LTD LIMITED ACID SECTOR II, KASEZ, TABLETS STRIP,1.0X
GANDHIDHAM - 370230, 7.0X3.0
GUJARAT TABLET
STRIP
684 NDA/MAL/H ROYAL ABACUS BETADERM BETAMETHAS 0.1%W/W ATCO LABORATORIES PVT PAKISTAN TOPICAL 1.0X15.0 7/1/1997
DP/1331 GROUP PHARMA N ONE + LTD-B-18,S.I.T.E KARACHI EXTERNAL G
(AFRICA) OINTMENT VALERATE + 0.5%W/W 75700, PAKISTAN OINTMENTS TUBE,1.0X
LIMITED NEOMYCIN 5.0 G
TUBE
685 NDA/MAL/H INTAS NORVIK PREGATAS PREGABALIN 75MG INTAS PHARMACEUTICALS INDIA ORAL SOLID 1.0X3.0X1 7/1/2012
DP/1335 PHARMACEUT ENTERPRISES LTD-CAMP ROAD SELAQUI ORDINARY 0.0
ICALS LTD LIMITED DEHRADUN CAPSULES CAPSULE
BLISTER
686 NDA/MAL/H LEBEN ANDYCO GRISEBEN GRISEOFULVI 500 MG LEBEN LABORATORIES PVT INDIA ORAL SOLID 1.0X10.0X 7/1/2016
DP/1338 LABORATORIE PHARMACY 500 N LTD --L4 PHASEIII M.I.D.C ORDINARY 10.0
S PVT LTD (UGANDA) LTD AKOLA 444 104 TABLETS TABLET
MAHARASHTRA BLISTER
687 NDA/MAL/H AUROLAB SWASTIK G-FLOX GATIFLOXACI 0.3%W/V AUROLAB-NO 1 INDIA OPHTHALMI 1.0X5.0 7/1/2016
DP/1341 PHARMACEUTIC N SIVAGANGAI MAIN ROAD, C LIQUIDS ML VIAL
AL LTD SESQUIHYDR VEERAPANJAN MADURAI
ATE – 625 020 TAMIL NADU,
INDIA
688 NDA/MAL/H KOTRA ABACUS AXCEL CEPHALEXIN 250MG KOTRA PHARMA (M) SDN. MALAYSIA ORAL SOLID 1.0X100.0 7/1/2008
DP/1342 PHARMA (M) PHARMA CEPHALEXI MONOHYDRA BHD-1 JALAN TTC 12, ORDINARY X10.0
SDN BHD (AFRICA) N 250 TE CHENG INDUSTRIAL CAPSULES CAPSULE
LIMITED ESTATE, 75250 MELAKA BLISTER,1.
MALYSIA 0X10.0X10
.0
CAPSULE
BLISTER
689 NDA/MAL/H MICRO LABS PHARMA VILLE PRAZIQUA PRAZIQUANT 600MG MICRO LABS LIMITED .,-92, INDIA ORAL SOLID 1.0X500.0 7/1/2013
DP/1343 LTD LIMITED NTEL EL SIPCOT, HOSUR 635126 ORDINARY TABLET
MICRO LABS LIMITED, TABLETS CONTAIN
BOMMASANDRA (ML07),- ER
PLOT 121-124, IV PHASE
KIADB, BOMMASANDRA
IND. AREA, JIGNI LINK
ROAD
690 NDA/MAL/H ALKEM ABACUS SWICH-200 CEFPODOXIM 200MG ALKEM LABORATORIES INDIA ORAL SOLID 1.0X1.0X1 7/1/2010
DP/1345 LABORATORIE PHARMA E LTD-VILLAGE – THANA, ORDINARY 0.0
S LIMITED (AFRICA) BADDI TEHSIL – TABLETS TABLET
LIMITED NALAGARH, DIST-SOLAN BLISTER
(HP), INDIA – 173205
691 NDA/MAL/H ASTRA ASTRA PHARMA ASIX FUROSEMIDE 40MG ASTRA LIFE CARE (INDIA) INDIA ORAL SOLID 1.0X10.0X 7/1/2010
DP/1346 PHARMA LTD (U) LIMITED PVT.LTD-PLOT NO. 57/P, ORDINARY 10.0
SARKHEJ-BAVLA TABLETS TABLET
HIGHWAY, POST RAJODA- BLISTER,1.
382220, TALUKA BAVLA, 0X1000.0
AHMEDABAD INDIA TABLET
CONTAIN
ER
692 NDA/MAL/H MICRO LABS LABOREX ORNILOX ORNIDAZOLE 500MG + MICRO LABS LTD-92, INDIA ORAL SOLID 1.0X1.0X1 7/1/2010
DP/1347 LIMITED UGANDA + OFLOXACIN 200MG SIPCOT INDUSTRIAL ORDINARY 0.0
TABLETS
693 NDA/MAL/H TORRENT KARURI VALPARIN SODIUM 500MG TORRENT INDIA ORAL SOLID 1.0X10.0X 7/1/2009
DP/1348 PHARAMACE PHARMACEUTIC CHRONO VALPROATE PHARMACEUTICAL LTD- ORDINARY 10.0
UTICALS LTD ALS LTD. 500 (CONTROLLE AHMEDABAD-MEHSANA FILM- TABLET
D RELEASE) HIGHWAY,TALUKA- COATED STRIP
KADI,DIST.MEHSANA,INDR TABLETS
AD-382721
694 NDA/MAL/H MEDLEY MEDVIN ATORIN ATORVASTATI 20MG MEDLEY INDIA ORAL SOLID 1.0X3.0X1 7/1/2014
DP/1351 PHARMACEUT PHARMA N CALCIUM PHARMACEUTICALS LTD,- ORDINARY 0.0
ICALS LTD LIMITED PLOT 18 & 19 SURVEY NO FILM- TABLET
378/7 & 379/ 2&3 ZARI COATED BLISTER
CAUSEWAY ROAD TABLETS
KACHIGAM
695 NDA/MAL/H MEDLEY MEDVIN PLATFREE CLOPIDOGREL 75MG MEDLEY INDIA ORAL SOLID 1.0X3.0X1 7/1/2014
DP/1352 PHARMACEUT PHARMA PHARMACEUTICALS LTD- ORDINARY 0.0
ICALS LTD LIMITED PLOT NO.18 AND 19, FILM- TABLET
SURVEY NO.378/8 & COATED BLISTER
ESTATE, KACHIGAM,
DAMAN-396210 INDIA
696 NDA/MAL/H MEDLEY MEDVIN KITPYLO - C LANSOPRAZO 30MG MEDLEY INDIA ORAL SOLID 1.0X7.0X1 7/1/2015
DP/1353 PHARMACEUT PHARMA LE + +500MG + PHARMACEUTICALS LTD,- ORDINARY .0X6.0
ICALS LTD LIMITED TINIDAZOLE + 250MG PLOT 18 & 19 SURVEY NO FILM- TABLET
CLARITHROM 378/7 & 379/ 2&3 ZARI COATED BLISTER
YCIN CAUSEWAY ROAD TABLETS (BLISTER
KACHIGAM CONTAINS
2
CAPSULES
AND 4
TABLETS)
697 NDA/MAL/H PIRAMAL TATA UGANDA SEVOFLURA SEVOFLURAN 100% V/V PIRAMAL ENTERPRISES INDIA OTHER 1.0X250.0 7/1/2010
DP/1355 HEALTHCARE LIMITED NE E LTD, INDIA-DIGWAL SYSTEMIC ML
LTD VILLAGE KOHIR MENDAL LIQUID BOTTLE
MEDAK DISTRICT,ANDHRA INHALATION
PRADESH S
698 NDA/MAL/H KAMPALA KAMPALA DIFENAC- DICLOFENAC 100MG KAMPALA UGANDA ORAL SOLID 1.0X10.0 7/1/2016
DP/1359 PHARMACEUT PHARMACEUTIC 100 SR SODIUM PHARMACEUTICAL RETARD CAPSULE
ICAL AL INDUSTRIES INDUSTRIES (1996) LTD- CAPSULES BLISTER
INDUSTRIES 1996 LIMITED PLOT M 444B STRETCHER
(1996) LTD ROAD NTINDA
699 NDA/MAL/H CIPLA LTD QUALITY ABAMUNE- ABACAVIR 60MG + CIPLA LTD-UNIT I & II A-32 INDIA ORAL SOLID 1.0X60.0 7/1/2016
DP/1360 CHEMICALS LTD - L BABY SULPHATE + 30MG & A-42 MIDC ORDINARY TABLET
HUMAN LAMIVUDINE PATALGANGA 410220 DIST- SOLUBLE CONTAIN
RAIGAD, MAHARASHTRA TABLETS ER
INDIA
700 NDA/MAL/H SWISS SHREEJI FALCI CARE ARTESUNATE 120MG SWISS PARENTERALS LTD- INDIA PARENTERAL 1.0X30.0 7/1/2016
DP/1361 PARENTERALS PHARMACEUTIC 809 KERALA IND ESTATE ORDINARY MG VIAL +
LTD ALS LIMITED GIDC NEAR BAVLA DIST DRY VIALS 1*5ML OF
AHMEDABAD 382220 0.9%W/V
GUJARAT INDIA NACL
AMPOULE
+ 1*1ML
OF
5%W/V
NAHCO3
AMPOULE
701 NDA/MAL/H MICRO LABS LABOREX BACTOCLAV- AMOXICILLIN 875 MG + MICRO LABS LIMITED - INDIA ORAL SOLID 1.0X2.0X6 7/1/2013
DP/1362 LIMITED UGANDA 1000 + 125 MG PLOT 16 VEERASANDRA ORDINARY .0 TABLET
LIMITED CLAVULANAT IND. AREA,ANEKAL FILM- STRIP
E TALUK,BANGALORE INDIA COATED
TABLETS
702 NDA/MAL/H F. HOFFMANN- LABOREX HERCEPTIN TRASTUZUMA 440MG F. HOFFMANN LA-ROCHE- SWITZERLAN PARENTERAL 1.0X440.0 7/1/2016
DP/1366 LA ROCHE LTD UGANDA 440MG B WURMISWEG CH-4303 D ORDINARY MG VIAL
LIMITED KAISERAUGST INFUSION ,2OML
DRY VIAL OF
VIALS/BOTTL SOLVENT
ES
703 NDA/MAL/H DAWA SUPER MEDIC ACEPAR ACECLOFENA 100 MG + DAWA LTD-BABA DOGO KENYA ORAL SOLID 1.0X10.0 7/1/2013
DP/1367 LIMITED LTD C+ 500 MG ROAD RUARAKA ORDINARY TABLET
PARACETAM TABLETS BLISTER
OL
DP/1368 PARENTERAL PARENTERAL DRUGS LIMITED-BLOCK ORDINARY ML
DRUGS DRUGS LIMITED 191, PLOT NO. 114, INFUSION BOTTLE,1.
LIMITED GWAWANYA KINGA AND VIALS/BOTTL 0X250.0
KAPEKA MUKONO ES ML
DISTRICT, UGANDA. BOTTLE
705 NDA/MAL/H MEDIPHARM MEDIPHARM ORALYTE DT ZINC-20 + 20G MEDICAMEN BIOTECH INDIA ORAL LIQUID 1.0X2.0X2 7/1/2016
DP/1369 (EA) LTD INDUSTRIES CO-PACK ORAL LTD,.-SP-1192 A&B PHASE ORDINARY 0.8 G
(E.A) LTD ORANGE REHYDRATIO IV INDUSTRIAL AREA SOLUBLE SACHET +
FLAVOUR N SALTS BHIWADI 301019 DIST. POWDERS 1.0 *10.0
(ORS) ALWAR (RAJASTHAN) - TABLET
INDIA MEDIPHARM BLISTER
INDUSTRIES( EA) LTD-PLOT
65 KAKAJJO ROAD
BWEYOGERERE P.O.BOX
6218,KAMPALA,UGANDA
AGOG PHARMA LTD-PLOT
NO.33,SECTOR
706 NDA/MAL/H ABACUS ABACUS STERILIZED WATER FOR NEUTRAL ABACUS PARENTERAL UGANDA PARENTERAL 1.0X5.0 7/1/2010
DP/1370 PARENTERAL PARENTERAL WATER FOR INJECTION DRUGS LIMITED-BLOCK ORDINARY ML
DRUGS DRUGS LIMITED INJECTION 191, PLOT NO. 114, AMPOULES AMPOULE
LIMITED GWAWANYA KINGA AND ,1.0X10.0
KAPEKA MUKONO ML
DISTRICT, UGANDA. AMPOULE
,1.0X7.5
ML
AMPOULE
707 NDA/MAL/H AXA VITACARE RL COMPOUND 0.115 G + AXA PARENTERALS LTD- INDIA PARENTERAL 1.0X500.0 7/1/2014
DP/1372 PARENTERALS LIMITED SODIUM 0.6G + KISHNPUR, JAMALPUR ORDINARY ML
LTD LACTATE 0.027 ROORKEE- 247677 INFUSION BOTTLE
(NACL + KCL + VIALS/BOTTL
CACL ) ES
708 NDA/MAL/H HILTON HEALTHCARE VALODIN - CEPHADRINE 125MG/5 HILTON PHARMA (PVT) PAKISTAN ORAL LIQUID 1.0X100.0 7/1/2003
DP/1374 PHARMA LTD. 125 ML LTD-PLOT 13 SECTOR 15 ORDINARY ML
(PVT) LTD KORANGI INDUSTRIAL DRY BOTTLE
AREA KARACHI SUSPENSION
S/SYRUPS/D
ROPS
709 NDA/MAL/H OTSUKA REDDYS WATER FOR WATER FOR N/A OTSUKA INDIA PARENTERAL 1.0X10.0 7/1/2014
DP/1377 PHARMACEUT PHARMA INJECTION INJECTION PHARMACEUTICAL INDIA ORDINARY ML
ICAL INDIA LIMITED PRIVATE LTD-VILLAGE – AMPOULES AMPOULE
PRIVATE VASANA –
LIMITED CHACHARWADIP, TAL:
SANAND, AHMADABAD
710 NDA/MAL/H KAMPALA KAMPALA HYCORT HYDROCORTI 1%W/W KAMPALA UGANDA TOPICAL 1.0X15.0 7/1/1997
DP/1380 PHARMACEUT PHARMACEUTIC CREAM SONE PHARMECEUTICALS EXTERNAL G
ICAL AL INDUSTRIES INDUSTRIES LTD.-PLOT CREAMS TUBE,1.0X
INDUSTRIES 1996 LIMITED M444B STRETCHER RD, 30.0 G
(1996) LTD NTINDA KLA UGANDA TUBE
711 NDA/MAL/H CIPLA LTD QUALITY LAMIVUDIN LAMIVUDINE, 150MG+30 CIPLA LTD.- -PLOT NO INDIA ORAL SOLID 1.0X60.0 7/1/2007
DP/1381 CHEMICALS LTD - E,/ + 0MG L/139 TO L/146, VERNA ORDINARY TABLET
HUMAN ZIDOVUDIN ZIDOVUDINE INDUSTRIAL ESTATE, FILM- BOTTLE
E TABLETS VERNA, SOUTH GOA COATED
DISTRICT, 403722 GOA TABLETS
712 NDA/MAL/H HOVID UNITED INOX ITRACONAZO 100MG HOVID BHD-LOT 56442, MALAYSIA ORAL SOLID 1.0X7.0X4 7/1/2012
DP/1382 BERHAD HEALTHCARE CAPSULES LE 7.5 MILE JALAN ORDINARY .0
DISTRIBUTORS IPOH/CHEMO 31200 CAPSULES CAPSULE
MALAYSIA
713 NDA/MAL/H HOVID BHD UNITED KETOFEN KETOPROFEN 2.5%W/W HOVID BHD (IPOH SITE)- MALAYSIA TOPICAL 1.0X30.0 7/1/2013
DP/1383 HEALTHCARE GEL 121 ,JALAN TUNKU ABDUL EXTERNAL G
DISTRIBUTORS RAHMAN , 30010 IPOH , GELS AND CONTAIN
LTD PERAK , MALAYSIA SOLS ER
714 NDA/MAL/H CIPLA LTD QUALITY LAMIVUDIN LAMIVUDINE 30MG + CIPLA LTD.- -PLOT NO INDIA ORAL SOLID 1.0X60.0 7/1/2013
DP/1384 CHEMICALS LTD - E AND + 60MG L/139 TO L/146, VERNA ORDINARY TABLET
HUMAN ZIDOVUDIN ZIDOVUDINE INDUSTRIAL ESTATE, ORALLY BOTTLE
E TABLETS VERNA, SOUTH GOA DISINTEGRA
DISTRICT, 403722 GOA TING
TABLETS
715 NDA/MAL/H INTAS NORVIK LAN-30 LANSOPRAZO 30MG INTAS PHARMACEUTICALS INDIA ORAL SOLID 1.0X1.0X5 7/1/2004
DP/1387 PHARMACEUT ENTERPRISES LE LTD-CAMP ROAD SELAQUI ORDINARY .0X10.0
ICALS LTD LIMITED DEHRADUN CAPSULES CAPSULE
STRIP
716 NDA/MAL/H UNIVERSAL HARLEYS NELSTAT NYSTATIN 100000 UNIVERSAL CORPORATION KENYA ORAL 1.0X30.0 7/1/2010
DP/1389 CORPORATIO UGANDA I.U/ML LIMITED -PLOT 13777 TOPICAL ML
N LTD LIMITED KIKUYU ROAD, KIKUYU SUSPENSION BOTTLE
TOWN, PAST POST OFFICE S
717 NDA/MAL/H ASTRA MACNAUGHTON CRESTOR ROSUVASTATI 5MG IPR PHARMACEUTICALS PUERTO RICO ORAL SOLID 1.0X2.0X1 7/1/2010
DP/1390 ZENECA LIMITED N CALCIUM INC,-LOT 17 INDUSTRIAL ORDINARY 4.0
PARK PUERTO RICO, SAN FILM- TABLET
ISIDRO, PUERTO RICO COATED BLISTER
TABLETS
718 NDA/MAL/H UNIVERSAL HARLEYS UNIVIR 5% ACYCLOVIR 5%W/W UNIVERSAL CORPORATION KENYA TOPICAL 1.0X1.0X1 7/1/2010
DP/1391 CORPORATIO UGANDA LIMITED -PLOT 13777 EXTERNAL 0.0 G
N LTD LIMITED KIKUYU ROAD, KIKUYU CREAMS TUBE
TOWN, PAST POST OFFICE
719 NDA/MAL/H ASTRA MACNAUGHTON ZOLADEX GOSERELIN 3.6MG ASTRA ZENECA UK UNITED PARENTERAL 1.0X1.0 7/1/1997
DP/1392 ZENECA LIMITED LIMITED-ASTRAZENECA UK KINGDOM ORDINARY PREFILLED
LIMITED SILK ROAD PRE-FILLED SYRINGE
BUSINESS PARK, MACCLES SYRINGES CARTON
2NA,
720 NDA/MAL/H ASTRA MACNAUGHTON NEXIUM ESOMEPRAZO 40MG/5ML ASTRA ZENECA-- SWEDEN PARENTERAL 1.0X1.0X5 7/1/2010
DP/1395 ZENECA AB LIMITED 40MG IV LE KVARNBERGAGATAN12, ORDINARY .0 ML
SE-151 SODERTALIJE VIALS VIAL,1.0X
10.0X5.0
ML VIAL
721 NDA/MAL/H ASTRAZENEC MACNAUGHTON PLENDIL FELODIPINE 10MG ASTRAZENECA AB,- SWEDEN ORAL SOLID 1.0X30.0 7/1/2001
DP/1397 A LIMITED GARTUNA & SNACKVIKEN ORDINARY TABLET
STOCKHOLM TABLETS CONTAIN
ER
722 NDA/MAL/H CIPLA LTD. QUALITY ASTHALIN SALBUTAMOL 100MCG/D CIPLA LTD .-PLOT NO. 9, INDIA LUNG 1.0X200.0 7/1/2010
DP/1399 CHEMICALS LTD - OSE 10 AND 15, INDORE ADMINISTRA METERED
HUMAN SPECIAL ECONOMIC ZONE, TION CFC- DOSE
PHASE –II, PITHAMPUR, FREE CANNISTE
DISTRICT DHAR, PIN METERED- R
CODE: 454775, MADHYA DOSE
PRADESH INHALER
723 NDA/MAL/H MEGA ABACUS PANFOR SR METFORMIN 500MG INVENTIA HEALTHCARE INDIA ORAL SOLID 1.0X5.0X2 7/1/2015
DP/1400 LIFESCIENCES PHARMA 500 HYDROCHLOR PRIVATE LIMITED-F1-F1/1, RETARD 0.0
(AUSTRALIA) (AFRICA) IDE ADDITIONAL AMBERNATH TABLETS TABLET
PTY LTD LIMITED MIDC, AMBERNATH BLISTER
(EAST), DISTRICT
THANE, 421 0506, DIST.
THANE,
MAHARASHTRA, INDIA.
724 NDA/MAL/H MEGA ABACUS PANFOR SR METFORMIN 1000MG INVENTIA HEALTHCARE INDIA ORAL SOLID 1.0X5.0X2 7/1/2015
DP/1402 LIFESCIENCES PHARMA 1000 HYDROCHLOR PRIVATE LIMITED-F1-F1/1, RETARD 0.0
(AUSTRALIA) (AFRICA) IDE ADDITIONAL AMBERNATH TABLETS TABLET
PTY LTD LIMITED MIDC, AMBERNATH BLISTER
(EAST), DISTRICT
THANE, 421 0506, DIST.
THANE,
MAHARASHTRA, INDIA.
725 NDA/MAL/H VHB MEDI LLOYDS DOMAXIN- DOXORUBICI 10MG VHB MEDI SCIENCES LTD- INDIA PARENTERAL 1.0X10.0 7/1/2010
DP/1403 SCIENCES LTD PHARMACY RD 10MG N HCL PLOT 20, 21, 22 & 49,50, ORDINARY MG VIAL
5, RUDRAPUR,
UTTARAKHAND - INDIA
726 NDA/MAL/H LEBEN ANDYCO CEBAY DRY CEFIXIME 50MG/5ML LEBEN LABORATORIES PVT INDIA ORAL LIQUID 1.0X100.0 7/1/2014
DP/1406 LABORATORIE PHARMACY SYRUP TRIHYDRATE LTD --L4 PHASEIII M.I.D.C ORDINARY ML
S PVT LTD (UGANDA) LTD AKOLA 444 104 DRY BOTTLE
MAHARASHTRA SUSPENSION
S/SYRUPS/D
ROPS
727 NDA/MAL/H PHARMATHE GOODMAN BELIFAX OMEPRAZOLE 20MG PHARMATHEN S.A- GREECE ORAL SOLID 1.0X14.0 7/1/1997
DP/1407 N S.A INTERNATIONAL 6,DERVENAKION ORDINARY CAPSULE
LTD STR,PALLINI,AHICA CAPSULES BOTTLE
GREECE
728 NDA/MAL/H TORRENT KARURI ROSUCOR ROSUVASTATI 20MG TORRENT INDIA ORAL SOLID 1.0X3.0X1 7/1/2011
DP/1408 PHARAMACE PHARMACEUTIC N PHARMACEUTICALS LTD- ORDINARY 0.0
UTICALS LTD ALS LTD. VILLAGE. BHUD-MAKHNU TABLETS TABLET
MAJRA, TEHSIL: BADDI BLISTER
173205 DIST SOLAN (H.P)
729 NDA/MAL/H SURGE LAB JEET ROMYCIN AZITHROMYCI 200MG/5 NABIQASIM INDUSTRIES PAKISTAN ORAL LIQUID 1.0X1.0X1 7/1/2007
DP/1409 (PVT) LIMITED PHARMACEUTIC N ML (PVT) LTD-- ORDINARY 5.0 ML
ALS LIMITED 17/24,KORANGI DRY BOTTLE
KORANGI, KARACHI- S/SYRUPS/D
PAKISTAN. ROPS
730 NDA/MAL/H LEBEN ANDYCO CIPIUM CHLORPHENI 4MG LEBEN LAB PVT LTD-L4 INDIA ORAL SOLID 1.0X1000. 7/1/2011
DP/1411 LABORATORIE PHARMACY RAMINE PHASE 111 MIDCS AKOLA ORDINARY 0 TABLET
S PVT LTD (UGANDA) LTD 444104 MAHARASTRA TABLETS CONTAIN
INDIA ER,1.0X10
.0X20.0
TABLET
BLISTER
731 NDA/MAL/H BETA BETA PODINE POVIDONE 0.1%W/V BETA HEALTHCARE KENYA ORAL 1.0X100.0 7/1/2014
DP/1413 HEALTHCARE HEALTHCARE MOUTH IODINE INTERNATIONAL LTD - - TOPICAL ML
INTERNATION UGANDA WASH PLOT LIQUIDS BOTTLE,1.
AL LTD LIMITED NO.209/6554,MOGADISHU 0X200.0
ROAD,OFF LUNGA LUNGA ML
INDUSTRIAL AREA, BOTTLE
P.O.BOX 42569-001000
NAIROBI,KENYA
732 NDA/MAL/H UNIQUE PLANET DICLORAN DICLOFENAC 100MG UNIQUE INDIA ORAL SOLID 1.0X10.0X 7/1/2016
DP/1414 PHARMACEUT PHARMACEUTIC SR TABLETS SODIUM PHARMACEUTICAL LABS ORDINARY 10.0
ICALS ALS UGANDA LIMITED. .-215-216, 216- ENTERIC- TABLET
LABORATORIE LTD 219, 304-308, GIDC COATED BLISTER
S PANOLI 394116-GUJARAT TABLETS
733 NDA/MAL/H ASTRA MACNAUGHTON ATACAND CANDESARTA 32MG ASTRA ZENECA SWEDEN SWEDEN ORAL SOLID 1.0X2.0X1 7/1/2011
DP/1415 ZENECA LIMITED N OPERATIONS-TABLET ORDINARY 4.0
PRODUCTION SE-151 85, TABLETS TABLET
GARTUNAVAGEN, BLISTER
SODERTALJE
734 NDA/MAL/H GLENMARK STAR MILICAL CALCIUM 1000MG GLENMARK INDIA ORAL SOLID 1.0X3.0X1 7/1/2001
DP/1417 PHARMACEUT PHARMACEUTIC TABLETS CITRATE + +200 I.U PHARMACEUTICALS LTD- ORDINARY 0.0
ICAL LTD ALS LTD VITAMIN D3 PLOT NO E -37, 39 ,D TABLETS TABLET
BLISTER
735 NDA/MAL/H SHOSAAN RENE AMINOPHY AMINOPHYLLI 100MG NEM LABORATORIES PVT INDIA ORAL SOLID 1.0X1000. 7/1/2011
DP/1418 ASIC PACIFIC PHARMACY LTD LLINE NE LTD-PLOT NO. 133 ORDINARY 0 TABLET
TABLETS KRISHNA IND. ESTATE, TABLETS CONTAIN
VASAI E,DIST PALGHAR- ER,1.0X10
401210, MAHARASHTRA .0X10.0
STATE TABLET
BLISTER
736 NDA/MAL/H GLOBAL NAPI WIDE SINOPRIL LISINOPRIL 10MG GLOBAL NAPI EGYPT ORAL SOLID 1.0X1.0X1 7/1/2005
DP/1419 PHARMACEUT SPECTRUM 10 PHARMACEUTICALS -2ND ORDINARY 0.0
ICALS ENTERPRISES INDUSTRIAL ZONE, NO.40, TABLETS TABLET
(U) LIMITED ST. NO 18, 6TH OCTOBER, BLISTER,1.
GIZA, 0X3.0X10.
0 TABLET
BLISTER
737 NDA/MAL/H SHAIGAN HEALTHCARE STAMIN CETIRIZINE 10MG SHAIGAN PAKISTAN ORAL SOLID 1.0X1.0X1 7/1/2005
DP/1422 PHARMACEUT LTD. DIHYDROCHL PHARMACEUTICALS (PVT) ORDINARY 0.0
ICALS LTD ORIDE LTD-14TH KM, ADYALA TABLETS TABLET
ROAD, RAWALPINDI- BLISTER
PAKISTAN
738 NDA/MAL/H SANDOZ SURGIPHARM CURAM AMOXYCILLIN 500MG+12 SANDOZ GMBH- AUSTRIA ORAL SOLID 1.0X7.0X2 7/1/2016
DP/1423 KENYA C/O (U) LIMITED + POTASSIUM 5MG BIOCHEMIESTRASSE 10, ORDINARY .0 TABLET
NOVARTIS CLAVULANAT A6250 KUNDL, TYROL, FILM- BLISTER
PHARMA E AUSTRIA COATED
SERVICES INC TABLETS
739 NDA/MAL/H LEBEN ANDYCO L-TRIM COTRIMOXAZ 240MG/5 LEBEN LABORATORIES INDIA ORAL LIQUID 1.0X60.0 7/1/2007
DP/1425 LABORATORIE PHARMACY OLE ML PVT. LTD-L-4, PHASE –III, ORDINARY ML
S PVT.LTD (UGANDA) LTD M.I.D.C, SUSPENSION BOTTLE,1.
S 0X1.0X100
.0 ML
BOTTLE
740 NDA/MAL/H LEBEN ANDYCO METROLEB METRONIDAZ 200MG LEBEN LABORATORIES PVT INDIA ORAL SOLID 1.0X10.0X 7/1/2015
DP/1426 LABORATORIE PHARMACY OLE LTD --L4 PHASEIII M.I.D.C ORDINARY 10.0
S PVT.LTD (UGANDA) LTD AKOLA 444 104 TABLETS TABLET
MAHARASHTRA BLISTER
741 NDA/MAL/H GITTOES GITTOES TENA-50 ATENOLOL 50MG AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1.0X3.0X1 7/1/2011
E INDIA TABLET
BLISTER,1.
0X10.0X10
.0 TABLET
BLISTER
742 NDA/MAL/H INTAS NORVIK TORTAS 10 TORSEMIDE 10MG INTAS PHARMACEUTICALS INDIA ORAL SOLID 1.0X3.0X1 7/1/2013
DP/1431 PHARMACUIT ENTERPRISES LIMITED -CAMP ROAD, ORDINARY 0.0
ICALS LTD LIMITED SELAQUI- TABLETS TABLET
248197,DEHRADUN BLISTER
UTTARAKHAND, INDIA
743 NDA/MAL/H CIRON DRUGS RENE CHLORAMP CHLORAMPH 5%W/V CIRON DRUGS AND INDIA OTIC DROPS 1.0X10.0 7/1/2007
DP/1432 & PHARMACY LTD HENICOL ENICOL PHARMACEUTICALS PVT ML VIAL
PHARMACEUT EAR DROPS LTD-N-118 M.I.D.C,
ICALS PVT LTD TAAPUR,BOISAR,DIST.THA
NE MAHARASHTRA INDIA
744 NDA/MAL/H BAYER SURGIPHARM NORISTERA NORETHISTER 200MG BAYER PHARMA A.G- GERMANY PARENTERAL 1.0 ML 7/1/1997
DP/1433 PHARMA AG (U) LIMITED T ONE MULLERSTRASSE 178, ORDINARY PRE-
ENANTATE 13353 BERLIN, GERMANY VIALS FILLED
SYRINGE,1
.0X100.0X
1.0 ML
VIAL
745 NDA/MAL/H MERCK (PTY) UNITED CONCOR 10 BISOPROLOL 10MG MERCK KGAA-250 GERMANY ORAL SOLID 1.0X3.0X1 7/1/2014
DP/1436 LTD HEALTHCARE HEMIFUMAR FRANKFRUTER STRASSE ORDINARY 0.0
DISTRIBUTORS ATE 250-64293 DARMSTADT FILM- TABLET
LTD WINTHROP COATED BLISTER
PHARMACEUTICALS(PTY) TABLETS
LTD,-315 WATLOO
ROAD,WATLOO,PRETORIA,
SOUTHAFRICA (FPP
SECONDARY
PACKAGING,FPP
RELEASE/QC TESTING
SITE)
746 NDA/MAL/H AXA VITACARE SODIUM SODIUM 0.9%W/V AXA PARENTERALS LTD- INDIA PARENTERAL 1.0X500.0 7/1/2014
DP/1441 PARENTERALS LIMITED CHLORIDE CHLORIDE KISHNPUR, JAMALPUR ORDINARY ML
LTD ROORKEE- 247677 INFUSION BOTTLE
VIALS/BOTTL
ES
747 NDA/MAL/H CADILA KARURI AXONE CEFTRIAXONE 1000MG CADILA INDIA PARENTERAL 1.0X1000. 7/1/2003
DP/1445 PHARMACEUT PHARMACEUTIC 1000 SODIUM PHARMACEUTICALS ORDINARY 0 MG VIAL
ICALS LIMITED ALS LTD. LIMITED-1389, TRASAD DRY VIALS
ROAD, DHOLKA- 382225,
STATE, INDIA
748 NDA/MAL/H RENE RENE VITAMIN B VITAMINS B1 0.5 MG + RENE INDUSTRIES LTD- UGANDA ORAL SOLID 1.0X1000. 7/1/2015
DP/1446 INDUSTRIES INDUSTRIES COMPLEX + B2 + B6 + 0.5MG + PLOT 680, KAMULI ROAD, ORDINARY 0 TABLET
LTD LIMITED NIACINAMIDE 7.5MG KIREKA, P.O BOX 6034, TABLETS CONTAIN
KAMPALA ER
749 NDA/MAL/H EGYPTIAN WIDE VITONA VITAMINS + MULTI- EGYPTIAN EGYPT ORAL SOLID 1.0X2.0X6 7/1/2014
DP/1447 INTERNATION SPECTRUM PLUS MINERALS INGREDIEN INTERNATIONAL ORDINARY .0
AL ENTERPRISES T PHARMACEUTICAL CAPSULES CAPSULE
PHARMACEUT (U) LIMITED INDUSTRIES COMPANY- BLISTER
ICAL 10TH OF RAMADAN CITY
INDUSTRIES FIRST INDUSTRIAL AREA
COMPANY
750 NDA/MAL/H NOVARTIS SURGIPHARM VOLTAREN DICLOFENAC 25MG/ML NOVARTIS PHARMA STEIN SWITZERLAN PARENTERAL 1.0X3.0 7/1/1997
DP/1451 PHARMA AG (U) LIMITED INJECTION AG- D ORDINARY ML
SCHAFFHARVSERTRASSE AMPOULES AMPOULE
CH-4332 STEIN
SWITZERLAND.
751 NDA/MAL/H ASTRA MACNAUGHTON ZESTORETIC LISINOPRIL/H 20MG/12.5 ASTRAZENECA UNITED ORAL SOLID 1.0X2.0X1 7/1/1997
DP/1452 ZENECA LIMITED YDROCHLORO MG MACCLESFIELD-CHESHIRE KINGDOM ORDINARY 4.0
THIAZIDE FILM- TABLET
COATED BLISTER
TABLETS
752 NDA/MAL/H RENE RENE PAINEX PARACETAM 500MG + RENE INDUSTRIES LTD- UGANDA ORAL SOLID 1.0X25.0X 7/1/2003
DP/1454 INDUSTRIES INDUSTRIES OL + ASPIRIN 400MG + PLOT 680, KAMULI ROAD, ORDINARY 4.0
LTD LIMITED + CAFFEINE 50 MG KIREKA, P.O BOX 6034, TABLETS TABLET
KAMPALA STRIP
753 NDA/MAL/H NABIQASIM JEET DYSEN SECNIDAZOLE 1000MG NABIQASIM INDUSTRIES PAKISTAN ORAL SOLID 1.0X2.0 7/1/2006
DP/1457 INDUSTRIES PHARMACEUTIC FORTE (PVT) LIMITED-17/24, ORDINARY TABLET
(PVT) LTD. ALS LIMITED KORANGI INDUSTRIAL TABLETS BLISTER
AREA, KARACHI, PAKISTAN
754 NDA/MAL/H NVS KENYA SURGIPHARM TASIGNA NILOTINIB 200MG NORVATIS PHARMA STEIN SWITZERLAN ORAL SOLID 1.0X2.0X1 7/1/2014
DP/1459 LTD (U) LIMITED 200 AG-SCHAFF HAUSER D ORDINARY 4.0
STRASSE 4332, STEIN - CAPSULES CAPSULE
SWITZERLAND BLISTER
755 NDA/MAL/H VENUS AARON PARIN E ENOXAPARIN 80MG VENUS REMEDIES LTD -- INDIA PARENTERAL 1.0X10.0X 7/1/2009
DP/1460 REMEDIES PHARMACEUTIC UNIT II HILL TOP ORDINARY 2.0 ML
LIMITED ALS LTD INDUSTRIAL ESTATE PRE-FILLED PRE-
JHARMAJRI EPIP PHASE I SYRINGES FILLED
BHATOLI KALAN BADDI SYRINGE
(H.P)
756 NDA/MAL/H ARISTO NORVIK ARISTOZYM DIASTASE+PE 50MG+10 ARISTO INDIA ORAL LIQUID 1.0X200.0 7/1/2015
DP/1463 PHARMACEUT ENTERPRISES E LIQUID PSIN MG PHARMACEUTICALS PVT. ORDINARY ML
ICALS LTD LIMITED LIMITED-PLOT NO. 208, LIQUIDS BOTTLE
NEW INDUSTRIAL AREA
NO. II, MANDIDEEP-
MADHYA PRADESH,
INDIA.
757 NDA/MAL/H ARISTO NORVIK ORNIDA ORNIDAZOLE 500MG ARISTO INDIA ORAL SOLID 1.0X3.0X1 7/1/2014
DP/1464 PHARMACEUT ENTERPRISES PHARMACEUTICALS PVT. ORDINARY 0.0
ICALS PVT LTD LIMITED LIMITED-PLOT NO. 208, FILM- TABLET
NEW INDUSTRIAL AREA COATED BLISTER,1.
NO. II, MANDIDEEP- TABLETS 0X10.0X10
462046, DIST. - RAISEN, .0 TABLET
MADHYA PRADESH, BLISTER
INDIA.
758 NDA/MAL/H NORVATIS SURGIPHARM VOLTFAST DICLOFENAC 50MG MIPHARM S.P.A -VIA ITALY ORAL LIQUID 1.0X3.0 7/1/2014
DP/1465 PHARMA AG (U) LIMITED 50MG POTASSIUM BERNARDO QUARANTA, ORDINARY SACHET
12-20141, MILANO ITALY. SOLUBLE CARTON,9
POWDERS .0X1.0X3.
0X3.0
SACHET
CARTON
759 NDA/MAL/H CADILA ABACUS OCID OMEPRAZOLE 20MG S KANT HEALTHCARE LTD- INDIA ORAL SOLID 1.0X10.0X 7/1/1998
DP/1468 HEALTHCARE PHARMA CAPSULES PLOT NO. 1802-1805, RETARD 10.0
LTD (AFRICA) G.I.D.C. PHASE III, VAPI CAPSULES CAPSULE
LIMITED 396 195. GUJARAT. STRIP
CADILA HEALTH CARE LTD-
KUNDAIM INDUSTRIAL
ESTATE, PLOT NO. 203-
213, KUNDAIM,GOA-403
115, INDIA
760 NDA/MAL/H VOGEN BUFFALO DURAMOX AMOXICILLIN 125MG/5 VOGEN LABORATORIES CYPRUS ORAL LIQUID 1.0X100.0 7/1/2007
DP/1469 LABORATORIE HEALTH CARE 125 ML LTD-70, M.HERACLEOUS ORDINARY ML
S LTD LTD STR. AYIOS ATHANASIOS DRY BOTTLE
LIMASSOL, CYPRUS S/SYRUPS/D
ROPS
761 NDA/MAL/H PT SAMBE MEDVIN TEMIRAL ACICLOVIR 30MG/G PT SANBE FARMA JI INDONESIA OPHTHALMI 1.0X3.5 G 7/1/2011
DP/1471 FARMA PHARMA INDUSTRI-NO.8 KOMPLEKS C TUBE
LIMITED INDUSTRI CIMAREME OINTMENTS
PADALARANG BANDUNG
762 NDA/MAL/H GLAXO UNITED FORTUM CEFTAZIDIME 1GM GLAXOSMITHKLINE LTD ITALY PARENTERAL 1.0X1.0 G 7/1/1997
DP/1472 WELLCOME HEALTHCARE INJECTION MANUFACTURING SPA- ORDINARY VIAL
(KENYA) LTD DISTRIBUTORS VERONA VIALS
LTD
763 NDA/MAL/H GITTOES GITTOES AGODIC DICLOFENAC 1%W/W AGOG PHARMA LTD-PLOT INDIA TOPICAL 1.0X30.0 7/1/2016
DP/1474 PHARMACEUT PHARMACEUTIC GEL DIETHYLAMIN NO. 33, SECTOR II, VASAI, EXTERNAL G TUBE
ICALS LIMITED ALS LIMITED E TALUKA INDL. GELS AND
SOLS
764 NDA/MAL/H GITTOES GITTOES SEPTOL SILVER 1%W/W + AGOG PHARMA LTD-PLOT INDIA TOPICAL 1.0X20.0 7/1/2016
DP/1476 PHARMACEUT PHARMACEUTIC SULFADIAZIN 0.20W/W NO. 33, SECTOR II, VASAI, EXTERNAL G TUBE
ICALS LIMITED ALS LIMITED E+ TALUKA INDL. CREAMS
CHLORHEXIDI
NE
GLUCONATE
765 NDA/MAL/H AJANTA ABACUS KAMAGRA SILDENAFIL 50MG AJANTA PHARMA LIMITED INDIA ORAL SOLID 1.0X1.0X4 7/1/2001
DP/1478 PHARMA LTD PHARMA PAITHAN- ORDINARY .0 TABLET
(AFRICA) MANUFACTURING UNIT B- TABLETS BLISTER
LIMITED 4/5/6 MIDC PAITHAN
DISTRICT AURANGABAD
431 148 MAHARASTRA
STATE INDIA
766 NDA/MAL/H ASTRA ASTRA PHARMA ASTROGYL METRONIDAZ 200MG ASTRA LIFE CARE (INDIA) INDIA ORAL SOLID 1.0X1000. 7/1/1997
DP/1481 PHARMA (U) (U) LIMITED OLE PVT LIMITED-57/P RAJODA ORDINARY 0 TABLET
LIMITED 382220 BAVIA TABLETS CONTAIN
AHMEDABAD INDIA ER,10.0X1
0.0
TABLET
BLISTER
767 NDA/MAL/H SANOFI LABOREX STAMARIL YELLOW NLT 1000 SANOFI PASTEUR-1541 FRANCE PARENTERAL 1.0X1.0 7/1/1997
DP/1482 PASTEUR UGANDA PASTEUR FEVER VIRUS I.U AVENUE MARCEL ORDINARY DOSE VIAL
LIMITED 17D-204 MERIEUX, 69280 MARCY, VIALS + 0.5ML
STRAIN(LIVE LETOILE SANOFI PASTEUR OF
ATTENUATED S.A-2,AVENUE PONT SOLVENT
) PASTEUR 69007 LYON- IN PRE-
FRANCE(BUSINESS FILLED
ADDRESS) SYRINGE,1
.0X10.0X1
0.0 DOSE
VIAL +
1*10*10
768 NDA/MAL/H UNITED WIDE DICLOFEN DICLOFENAC 25MG UNITED JORDAN RECTAL 1.0X2.0X5 7/1/2011
DP/1485 PHARMACEUT SPECTRUM 25 PHARMACEUTICAL SYSTEMIC .0
ICAL ENTERPRISES MANUFACTURING SUPPOSITORI SUPPOSIT
MANUFACTU (U) LIMITED COMPANY LTD-P.O BOX ES ORY
RING 69 AMMAN 11591 BLISTER
SECURITY HOUSING
769 NDA/MAL/H ABACUS ABACUS AMPIMAX- AMPICILLIN 1G REYOUNG CHINA PARENTERAL 1.0X50.0X 7/1/2011
DP/1486 PHARMA (A) PHARMA 1 PHARMACEUTICAL CO. ORDINARY 1.0 G VIAL
LTD. (AFRICA) LTD-NO. 6 ERLANGSHAN DRY VIALS
SHANDONG PROVINCE
P.R. 256100
770 NDA/MAL/H ERIS LTD BENLE CONSULT DICLO- DICLOFENAC 100MG HAUPT PHARMA WULFING GERMANY RECTAL 10.0X1.0X 7/1/2000
DP/1488 LIMITED DENK 100 SODIUM GMBH.-BETHELNER SYSTEMIC 2.0X5.0
RECTAL LANDSTR. 18, 31028 ADULT SUPPOSIT
GRONAU SUPPOSITORI ORY
ES STRIP,1.0X
5.0
SUPPOSIT
ORY STRIP
771 NDA/MAL/H ERIS LTD BENLE CONSULT DICLO- DICLOFENAC 25MG/ML HAUPT PHARMA WULFING GERMANY PARENTERAL 1.0X10.0X 7/1/1998
DP/1492 LIMITED DENK 75 SODIUM GMBH;--BETHELNER ORDINARY 3.0 ML
INJECTION LANDSTR. 18, 31028 AMPOULES AMPOULE
GRONAULLEIRE,
GERMANY.
772 NDA/MAL/H AUROBINDO GITTOES KOACT AMOXICILLIN 875MG/12 AUROBINDO PHARMA LTD- INDIA ORAL SOLID 1.0X3.0X5 7/1/2007
DP/1493 PHARMA LTD PHARMACEUTIC 1000 /CLAVULANA 5MG UNIT VII (SEZ), PLOT RETARD .0 TABLET
ALS LIMITED TE NO.S1, GREEN INDUSTRIAL TABLETS BLISTER
POTASSIUM PARK,
POLEPALLY (V) JEDCHERIA
(M), MAHABOOB NAGAR
773 NDA/MAL/H FERRER LABOREX PEITEL PREDNICARB 0.25%W/W FERRER INTERNACIONAL, SPAIN TOPICAL 1.0X30.0 7/1/2013
DP/1494 INTERNACION UGANDA 0.25% ATE S.A-JOAN BUCSALA 1-9, EXTERNAL G TUBE
AL S.A LIMITED 08173 SANT CUGAT DEL CREAMS
VALLES, BARCELONA,
SPAIN
774 NDA/MAL/H WOCKHARDT STAR PELOX-400 PEFLOXACIN 400MG WOCKHARDT LIMITED -- INDIA ORAL SOLID 1.0X10.0 7/1/1997
DP/1495 LTD PHARMACEUTIC PLOT 57 VILLAGE ORDINARY TABLET
ALS LTD KUNJHAL, JHAMAJRI, TABLETS STRIP
BAROTIWALA, BADDI,
TEHSIL-NALAGARH,
DISTRICT SOLAN, 174103
HIMACHAL PRADESH,
INDIA
775 NDA/MAL/H LABORATORY HARLEYS LAEOVATE BETAMETHAS 0.1%W/W LABORATORY & ALLIED KENYA TOPICAL 1.0X1.0X1 7/1/1997
DP/1497 AND ALLIED UGANDA CREAM ONE LTD--PLOT NO. 209/ EXTERNAL 5.0 G
LTD LIMITED VALERATE 10349, OPP. SAMEER CREAMS TUBE
BUSINESS PARK,
MOMBASA ROAD P.O.
BOX 42875, GPO 00100,
NAIROBI, KENYA
776 NDA/MAL/H GITTOES GITTOES PROMETHA PROMETHAZI 25MG/ML NINGBO DAHONGYING CHINA PARENTERAL 1.0X2.0 7/1/2005
DP/1499 PHARMACEUT PHARMACEUTIC ZINE NE PHARMACEUTICALS LTD- ORDINARY ML
ICALS LIMITED ALS LIMITED HYDROCHLOR NO. 396 MIN AMPOULES AMPOULE
IDE
777 NDA/MAL/H MERCK PHILLIPS ATRIPLA EFAVIRENZ+E 600MG PATHEON INC- NETHERLAND ORAL SOLID 1.0X30.0 7/1/2008
DP/1500 SHARP & PHARMACEUTIC MTRICITABIN +200MG+3 MISSISSAUGA,ON L5N 7K9 S ORDINARY TABLET
DOHME BV ALS (UGANDA) E+ 00MG CANADA TABLETS CONTAIN
LIMITED TENOFOVIR ER
778 NDA/MAL/H MEDICAL KARURI SEDIPROCT HYDROCORTI 0.5%W/W MEDICAL UNION PHARMA EGYPT TOPICAL 1.0X20.0 7/1/2003
DP/1503 UNION PHARMACEUTIC CREAM SONE+CINCH + .CO-ABU-SULTAN ISMAILIA EXTERNAL G TUBE
PHARMACUIT ALS LTD. OCAINE 0.5%W/W EGYPT OTHER
ICALS CREAMS
779 NDA/MAL/H GLAXOSMITH UNITED SERETIDE SALMETEROL 25/50 MCG GLAXO WELLCOME FRANCE LUNG 1.0X1.0 7/1/2007
DP/1505 KLINE HEALTHCARE EVOHALER / PRODUCTION-ZONE ADMINISTRA CANNISTE
PHARMACEUT DISTRIBUTORS FLUTICASONE INDUSTRIELLE NO.2 TION CFC- R CARTON
ICAL KENYA LTD PROPIONATE 23 RUE LAVOISER 27000 FREE
LTD EVREUX METERED-
DOSE
INHALER
780 NDA/MAL/H WOCKHARDT STAR WEPOX RECOMBINAN 2000 IU WOCKHARDT LIMITED -- INDIA PARENTERAL 1.0X0.5 7/1/2011
DP/1506 LTD PHARMACEUTIC 2000 T HUMAN WOCKHARDT BIOTECH ORDINARY ML PRE-
ALS LTD ERYTHROPOI PARK, H14/2, M.I.D.C, PRE-FILLED FILLED
ETIN WALUJ, AURANGABAD SYRINGES SYRINGE
431136 MAHARASHTRA
INDIA
781 NDA/MAL/H IMMUCOR SUPER MEDIC WOMNIL ALBENDAZOL 200MG/5 DAWA-PLOT 7879, BABA KENYA ORAL LIQUID 1.0X10.0 7/1/2009
DP/1508 LTD E ML DOGO ROAD RUARAKA, ORDINARY ML
NAIROBI, KENYA SUSPENSION BOTTLE
S
782 NDA/MAL/H BETA BETA FEVEREX PARACETAM 500MG BETA HEALTHCARE KENYA ORAL SOLID 1.0X2.0X1 7/1/2007
DP/1509 HEALTHCARE HEALTHCARE OL INTERNATIONAL LTD-PLOT ORDINARY 0.0
UGANDA UGANDA LR 209/6554 MOGADISHU TABLETS TABLET
LIMITED LIMITED ROAD, OFF LUNGA LUNGA BLISTER,1.
ROAD, INDUSTRIAL AREA 0X10.0X10
NAIROBI, 00100, .0 TABLET
BLISTER
783 NDA/MAL/H JOHNSON PHILLIPS LISTERINE THYMOL + 12.78MG/2 JOHNSON&JOHNSON PTY SOUTH ORAL LIQUID 1.0X500.0 7/1/2001
DP/1510 &JOHNSON PHARMACEUTIC ANTISEPTIC ALCOHOL 0ML + LTD.-EDMS BPK241 MAIN AFRICA ORDINARY ML
(PTY) LTD ALS (UGANDA) 95% 5.60ML/M ROAD /HOOFWEG LIQUIDS BOTTLE,1.
LIMITED L 241,RETREAT 7945,SOUTH 0X250.0
AFRICA ML
BOTTLE
784 NDA/MAL/H JOHNSON&JO PHILLIPS VERMOX MEBENDAZOL 100MG SPECPHARM HOLDINGS- SOUTH ORAL SOLID 1.0X6.0 7/1/1997
DP/1514 HNSON PTY PHARMACEUTIC E 15TH ROAD HALFWAY AFRICA ORDINARY TABLET
LTD ALS (UGANDA) HOUSE JOHNSON & CHEWABLE BLISTER
LIMITED JOHNSON (PTY) LTD-241 TABLETS
MAIN ROAD, RETREAT,
7945, CAPE TOWN
785 NDA/MAL/H CIPLA LTD. QUALITY CIPLACEF CEFTRIAXONE 1000MG CIPLA LTD C/O OKASA- INDIA PARENTERAL 1.0X15.0 7/1/2007
DP/1515 CHEMICALS LTD - 1000 OKASA PHARMA PVT LTD L- ORDINARY ML VIAL
HUMAN 2 ADDITIONAL MIDC DRY VIALS 1X1 WFI
SATARA 415004 AMPOULE
786 NDA/MAL/H WIN- SURGIPHARM URGENDOL TRAMADOL/ 37.5MG/ WIN MEDICARE PVT INDIA ORAL SOLID 1.0X10.0X 7/1/2011
DP/1516 MEDICARE (U) LIMITED P PARACETAM 325MG LIMITED-MEERUT, ORDINARY 10.0
LTD OL MUZAFFARNAGER ROAD, TABLETS TABLET
MODIPURAM – 250110, BLISTER
UTTAR
PRADESH - INDIA
787 NDA/MAL/H SHOSAAN RENE VEST COMPOUND MULTI NEM LABORATORIES PVT INDIA TOPICAL 1.0X15.0 7/1/1998
DP/1517 ASIC PACIFIC PHARMACY LTD MENTAMU METHYLSALIC INGREDIEN LTD-133 VASAI RD(E) 401 EXTERNAL G TUBE
BALM YLATE T 162 SB MARG. LOWER OINTMENTS
PAREL MUMBAI
788 NDA/MAL/H CADILA ABACUS FORMONID BUDESONIDE 120 CADILA HEALTHCARE LTD-- INDIA LUNG 1.0X1.0 7/1/2007
DP/1519 HEALTHCARE PHARMA E 400 + METERED -SARKHEJ-PLOT ADMINISTRA CANNISTE
LTD (AFRICA) FORMOTEROL DOSES 417,419,420, SARKHEJ- TION R CARTON
LIMITED FUMARATE (400MCG/ BAVLA NH METERED-
6MCG) NO.8A,VILLAGE: MORAIYA DOSE
TAL: SANAND DISTRICT INHALER
AHMEDABAD 382210
789 NDA/MAL/H GLAXOSMITH UNITED PENAMOX AMOXYCILLIN 250MG MEDREICH STERILAB LTD- INDIA ORAL SOLID 10.0X10.0 7/1/1997
DP/1522 KLINE HEALTHCARE 12TH MILE, OLD MADRAS ORDINARY CAPSULE
PHARMACEUT DISTRIBUTORS ROAD, VIRGONAGOR, CAPSULES BLISTER,1.
ICAL KENYA LTD BANGALORE 560049, 0X1000.0
LTD INDIA CAPSULE
CONTAIN
ER
790 NDA/MAL/H RENE RENE AMPIREN AMPICILLIN 125MG/5 RENE INDUSTRIES LIMITED- UGANDA ORAL LIQUID 1.0X100.0 7/1/2007
DP/1523 INDUSTRIES INDUSTRIES ML PLOT 680, KAMULI ROAD, ORDINARY ML
LIMITED LIMITED KIREKA DRY BOTTLE
SUSPENSION
S/SYRUPS/D
ROPS
791 NDA/MAL/H RENE RENE AMOXIREN AMOXICILLIN 125 MG / 5 RENE INDUSTRIES LIMITED- UGANDA ORAL LIQUID 1.0X100.0 7/1/2008
DP/1524 INDUSTRIES INDUSTRIES TRIHYDRATE ML PLOT 680, KAMULI ROAD, ORDINARY ML
LIMITED LIMITED KIREKA DRY BOTTLE
SUSPENSION
S/SYRUPS/D
ROPS
792 NDA/MAL/H CIPLA QUALITY BENDEX ALBENDAZOL 20MG/5ML CIPLA LTD ,,-PLOT NO. INDIA ORAL LIQUID 1.0X10.0 7/1/2007
DP/1525 LIMITED. CHEMICALS LTD - E 9,10,15 INDORE SPECIAL ORDINARY ML
HUMAN ECONOMIC ZONE PHASE II SUSPENSION BOTTLE
PITHAMPUR DISTRICT S
DHAR MADHYA PRADESH
PIN. 454775
793 NDA/MAL/H FERRER LABOREX GAMALATE MAGNESIUM 75MG + FERRER INTERNATIONAL, SPAIN ORAL SOLID 1.0X2.0X1 7/1/2015
DP/1526 INTERNACION UGANDA B6 GLUTAMATE 75MG + S.A.-C/JOAN BUSCALLA, 1- ORDINARY 0.0
AL S.A LIMITED HYDROBROM 37MG + 9.08173 SANT CUGAT DEL TABLETS TABLET
IDE + 37MG VALLES, BARCELONA BLISTER
AMINOBUTYR
IC ACID +
AMINO
HYDROXYBUT
YRIC ACID +
VITAMIN B6
794 NDA/MAL/H MICRO LABS LABOREX BACTOCLAV AMOXICILLIN 200MG + MICRO LABS LIMITED.- INDIA ORAL LIQUID 1.0X1.0X1 7/1/2012
DP/1527 LTD UGANDA + 28.5MG/ PLOT 16, VEERASANDRA ORDINARY 00.0 ML
LIMITED CLAVULANAT 5ML IND. AREA,ANEKAL TALUK, DRY BOTTLE
E POTASSIUM BANGALORE INDIA SUSPENSION
S/SYRUPS/D
ROPS
795 NDA/MAL/H MICRO LABS LABOREX BACTOCLAV- AMOXYCILLIN 500 MG + MICRO LABS LIMITED - INDIA ORAL SOLID 1.0X1.0X6 7/1/2007
DP/1528 LTD UGANDA 625 + 125 MG PLOT 16 VEERASANDRA ORDINARY .0 TABLET
LIMITED CLAVULANAT IND. AREA,ANEKAL TABLETS BLISTER,1.
E POTASSIUM TALUK,BANGALORE INDIA 0X2.0X10.
0 TABLET
BLISTER
796 NDA/MAL/H BAYER SURGIPHARM PROVIRON MESTEROLON 25MG BAYER WEIMAR GMBH & GERMANY ORAL SOLID 1.0X2.0X1 7/1/1997
DP/1529 PHARMA AG (U) LIMITED E CO. KG- ORDINARY 0.0
DOBEREINERSTRASSE 20 D- TABLETS TABLET
99427 WEIMAR, BLISTER
GERMANY
797 NDA/MAL/H BF HARLEYS NOVAPRES TERLIPRESSIN 1MG/VIAL BF BIOSCIENCES LTD. - PAKISTAN PARENTERAL 1.0X1.0 7/1/2014
DP/1532 BIOSCIENCES UGANDA SIN RAIWIND,PAKISTAN ORDINARY MG VIAL
LTD LIMITED VIALS
798 NDA/MAL/H OTSUKA REDDYS 5D GLUCOSE 50G/L OTSUKA INDIA PARENTERAL 1.0X500.0 7/1/2007
DP/1533 PHARMACEUT PHARMA PHARMACEUTICAL INDIA ORDINARY ML
ICAL INDIA LIMITED PRIVATE LTD-VILLAGE – INFUSION BOTTLE,1.
PRIVATE VASANA – VIALS/BOTTL 0X250.0
LIMITED CHACHARWADIP, TAL: ES ML
SANAND, AHMADABAD BOTTLE
799 NDA/MAL/H ABACUS ABACUS FORTIWIN- FORTIFIED 4 M.U REYOUNG CHINA PARENTERAL 1.0X50.0X 7/1/2011
DP/1535 PHARMA LTD PHARMA 4 PROCAINE PHARMACEUTICAL CO. ORDINARY 4.0 MU
(AFRICA) PENICILLIN LTD-NO. 6 ERLANGSHAN DRY VIALS VIAL
LIMITED SODIUM ROAD, YIYUAN,
SHANDONG PROVINCE
P.R. 256100
800 NDA/MAL/H ELYS VELVET ELYZOLE ALBENDAZOL 200MG ELYS CHEMICAL KENYA ORAL SOLID 1.0X20.0X 7/1/2005
DP/1537 CHEMICAL PHARMA E INDUSTRIES LIMITED- ORDINARY 2.0
INDUSTRIES LIMITED ROAD B’, OFF ENTERPRISE TABLETS TABLET
LTD ROAD BLISTER
PLOT NO. 209/8927
INDUSTRIAL AREA
801 NDA/MAL/H ELYS VELVET ELYZOLE ALBENDAZOL 200MG ELYS CHEMICAL KENYA ORAL LIQUID 1.0X10.0 7/1/2003
DP/1538 CHEMICAL PHARMA SUSPENSIO E INDUSTRIES LIMITED- ORDINARY ML
INDUSTRIES LIMITED N ROAD B’, OFF ENTERPRISE SUSPENSION BOTTLE
LTD ROAD S
PLOT NO. 209/8927
INDUSTRIAL AREA
802 NDA/MAL/H MEDIPHARM MEDIPHARM PROMAZIN PROMETHAZI 5MG/ML MEDIPHARM INDUSTRIES( UGANDA ORAL LIQUID 1.0X60.0 7/1/1997
DP/1543 SALES INDUSTRIES E ELIXIR NE EA) LTD-PLOT 65 KAKAJJO ORDINARY ML
LIMITED (E.A) LTD HYDROCHLOR ROAD BWEYOGERERE LIQUIDS BOTTLE
IDE P.O.BOX
6218,KAMPALA,UGANDA
803 NDA/MAL/H GITTOES GITTOES PROMETHA PROMETHAZI 25MG AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1.0X1000. 7/1/2004
DP/1544 PHARMACEUT PHARMACEUTIC ZINE NE HCL NO.33,SECTOR ORDINARY 0 TABLET
ICALS LIMITED ALS LIMITED HYDROCHL II,VASAI,TALUKA INDL CO- TABLETS CONTAIN
ORIDE B.P OP ESTATE LTD,GAURAI ER,1.0X10
PADA,VASAI(E)DIST.THAN .0X10.0
E INDIA TABLET
BLISTER
804 NDA/MAL/H UNICHEM PHILLIPS LANPRO LANSOPRAZO 30MG UNICHEM LABORATORIES INDIA ORAL SOLID 1.0X5.0X2 7/1/1999
DP/1546 LABORATORIE PHARMACEUTIC LE LTD-PLOT NO. ORDINARY .0X10.0
S LTD ALS (UGANDA) 15,16,17,17A & 18, CAPSULES CAPSULE
LIMITED PILERNE INDUSTRIAL BLISTER
ESTATE, PILERNE, BARDEZ,
GOA- 403511
805 NDA/MAL/H MYLAN KIMSY MEDS LUSIA-F NORGESTREL 0.3MG/ MYLAN LABORATORIES INDIA ORAL SOLID 1.0X3.0X2 7/1/2007
DP/1547 LABORATORIE LTD / ETHINYL 0.03MG + LIMITED.--PLOT NO. 1606- ORDINARY 8.0
S LIMITED ESTRADIOL + 75MG 1609, SARIGAM TABLETS TABLET
FERROUS INDUSTRIAL AREA, GIDC, BLISTER
FUMARATE SARIGAM, TAL-UMERGAM,
PLOT NO.20 & 21,
PHARMEZ, SARKHEJ-
BAVLA NATIONAL
806 NDA/MAL/H GALENTIC VITACARE RUBIGEL MULTI- MULTI- GALENTIC PHARMA PVT. INDIA ORAL 1.0X30.0 7/1/2007
DP/1550 PHARMA LTD LIMITED INGREDIENT INGREDIEN LIMITED -R-673, TTC TOPICAL G TUBE
T MIDC, RUBALE, THANE GELS AND
BELAPUR NAVI MUMBAI SOLS
400 701
INDIA
807 NDA/MAL/H EMCURE HARLEYS CALOSHELL- CALCIUM 1250MG + EMCURE INDIA ORAL SOLID 1.0X10.0X 7/1/2004
DP/1551 PHARMACEUT UGANDA 500 CARBONATE 250IU PHARMACEUTICALS LTD- ORDINARY 10.0
ICALS LTD LIMITED + VITAMIN D3 LANE NO.3 PHASE II SIDCO FILM- TABLET
INDUSTRIAL COMPLEX COATED BLISTER
BARI BRAHMANA JAMMU TABLETS
(J&K) 18113
808 NDA/MAL/H EMCURE HARLEYS VIFEX SALBUTAMOL 1MG/5ML+ EMCURE INDIA ORAL LIQUID 1.0X100.0 7/1/2004
DP/1553 PHARMACEUT UGANDA + 2MG/5ML+ PHARMACEUTICALS LTD- ORDINARY ML
ICALS LTD LIMITED BROMHEXINE 50MG/5ML LANE NO.3 PHASE II SIDCO SYRUPS BOTTLE
+ INDUSTRIAL COMPLEX
GUAIFENESIN BARI BRAHMANA JAMMU
(J&K) 18113
809 NDA/MAL/H KOTRA ABACUS AXCEL CETIRIZINE 5MG/5ML KOTRA PHARMA (M) SDN. MALAYSIA ORAL LIQUID 1.0X60.0 7/1/2010
DP/1554 PHARMA (M) PHARMA CETIRIZINE DIHYDROCHL BHD-1 JALAN TTC 12, ORDINARY ML
SDN BHD (AFRICA) ORIDE CHENG INDUSTRIAL SYRUPS BOTTLE
MALYSIA
810 NDA/MAL/H GALENTIC VITACARE GALSCRUB CHLORHEXIDI 4%W/W GALENTIC PHARMA PVT. INDIA TOPICAL 1.0X500.0 7/1/2008
DP/1555 PHARMA LTD LIMITED NE LIMITED -R-673, TTC EXTERNAL ML
MIDC, RUBALE, THANE LIQUIDS BOTTLE
BELAPUR NAVI MUMBAI
400 701
INDIA
811 NDA/MAL/H VIRBAC RSA METRO DOMI UP ONDASENTR 2MG/ML LINCOLN PARENTERAL LTD- INDIA PARENTERAL 1.0X10.0X 7/1/2014
DP/1556 (PTY) LTD PHARMACEUTIC ON 11, TRIMUL ESTATE, NEAR ORDINARY 2.0 ML
ALS LIMITED KHATRAJ CHOLADI, P.O. AMPOULES AMPOULE
KHATRAJ-382721 TA:
KALOL, DIST.
812 NDA/MAL/H GLAXOSMITH UNITED SYNFLORIX PNEUMOCOC 1MCG+3M GLAXOSMITHKLINE BELGIUM PARENTERAL 1.0X0.5 7/1/2010
DP/1557 KLINE HEALTHCARE VACCINE CAL CG+13MCG BOILOGICALS-S.A RUE DE ORDINARY ML PRE-
DISTRIBUTORS POLYSACCHA +8MCG+5 I'INSTITUT 89 B-1330 PRE-FILLED FILLED
LTD RIDE MCG+0.5M RIXENSART SYRINGES SYRINGE
SEROTYPES G (1
(1,5,6B,7F,9V, DOSE),1.0
14,23F) + X100.0X0.
(4,18C,19F) + 5 ML VIAL
PROTEIN (1 DOSE)
D+TETANUS
TOXOID+DIPT
HERIA
813 NDA/MAL/H PFIZER LABOREX GABBRORA AMINOSIDINE 250MG PHARMACIA AND UPJOHN BELGIUM ORAL SOLID 1.0X12.0 7/1/1998
DP/1558 LABORATORIE UGANDA L SULPHATE S.P.A-RIJKSWEG 12, B- ORDINARY TABLET
S (PTY) LTD LIMITED 2870 PUURS TABLETS STRIP
814 NDA/MAL/H GLAXOSMITH UNITED AMOXIL AMOXYCILLIN 125MG/5 GLAXO WELLCOME FRANCE ORAL LIQUID 1.0X100.0 7/1/1997
DP/1563 KLINE HEALTHCARE ML PRODUCTION.-ZONE ORDINARY ML
PHARMACEUT DISTRIBUTORS INDUSTRIELLE DE LA DRY BOTTLE
ICAL KENYA LTD PEYENNIERE 53100 SUSPENSION
LTD MAYENNE, FRANCE S/SYRUPS/D
ROPS
815 NDA/MAL/H GITTOES GITTOES VITAVIT MULTI- MULTI- AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1.0X10.0X 7/1/2009
DP/1566 PHARMACEUT PHARMACEUTIC INGREDIENT INGREDIEN NO.33,SECTOR ORDINARY 10.0
ICALS LIMITED ALS LIMITED T II,VASAI,TALUKA INDL CO- OTHER TABLET
E INDIA TABLET
CONTAIN
ER
816 NDA/MAL/H ABBVIE (PTY) MEDICAL KALETRA LOPINAVIR+R 80MG + AESICA UNITED ORAL LIQUID 1.0X5.0X1 7/1/2007
DP/1569 LTD ACCESS ITONAVIR 20MG PHARMACEUTICALS SRL- KINGDOM ORDINARY .0X60.0
(UGANDA) QUEENBOROUGH KENT DRY ML
LIMITED ME 11 5EL, UNITED SUSPENSION BOTTLE
KINGDOM S/SYRUPS/D
ROPS
817 NDA/MAL/H BHARAT ABACUS RHOCLONE MONOCLONA 300MCG BHARAT SERUMS AND INDIA PARENTERAL 1.0X2.0 7/1/2013
DP/1571 SERUMS AND PHARMA L ANTI-D VACCINES LIMITED,-PLOT ORDINARY ML VIAL
VACCINES LTD (AFRICA) IMMUNOGLO NO. K-27, ADDITIONAL DRY VIALS (1 DOSE
LIMITED BULIN MIDC, VIAL)
AMBERNATH (EAST),
INDIA
818 NDA/MAL/H INTAS, NORVIK AMTAS-5 AMLODIPINE 5MG INTAS PHARMACEUTICALS INDIA ORAL SOLID 2.0X2.0X7 7/1/2003
DP/1574 PHARMACEUT ENTERPRISES LIMITED(BIOPHARMA ORDINARY .0 TABLET
ICALS LTD LIMITED DIVISION)-CAMP ROAD TABLETS BLISTER,1
SELAQUI-248197, 0.0X10.0
DEHRADUN TABLET
(UTTARAKHAND) INDIA BLISTER
819 NDA/MAL/H ASTRAZENEC MACNAUGHTON ZESTRIL LISINOPRIL 20MG ASTRAZENECA UNITED ORAL SOLID 1.0X2.0X1 7/1/1997
DP/1575 A LIMITED PHARMACEUTICALS LP - KINGDOM ORDINARY 4.0
HUANGSHAN ROAD, WUXI TABLETS TABLET
214028, JIANGSU, CHINA. BLISTER
ASTRAZENECA
MACCLESFIELD-CHESHIRE
820 NDA/MAL/H ASTRAZENEC MACNAUGHTON ZESTRIL LISINOPRIL 10MG ASTRAZENECA UNITED ORAL SOLID 1.0X1.0X1 7/1/1997
DP/1576 A LIMITED PHARMACEUTICALS LP - KINGDOM ORDINARY 4.0
HUANGSHAN ROAD, WUXI TABLETS TABLET
214028, JIANGSU, CHINA. BLISTER,1.
ASTRAZENECA 0X2.0X14.
MACCLESFIELD-UNITED 0 TABLET
KINGDOM BLISTER
821 NDA/MAL/H PT SANBE MEDVIN PLASMINEX TRANEXAMIC 100MG/ML PT SANBE FARMA JI INDONESIA PARENTERAL 1.0X10.0X 7/1/2011
DP/1579 FARMA PHARMA ACID INDUSTRI-NO.8 KOMPLEKS ORDINARY 5.0 ML
LIMITED INDUSTRI CIMAREME AMPOULES AMPOULE
PADALARANG BANDUNG
822 NDA/MAL/H INDOCO STAR ABZEE ALBENDAZOL 200MG/5 INDOCO REMEDIES LTD-B- INDIA ORAL LIQUID 1.0X10.0 7/1/2001
DP/1583 REMEDIES PHARMACEUTIC E ML 20, MIDC, WALUJ, ORDINARY ML
LIMITED ALS LTD AURANGABAB 431136 SUSPENSION BOTTLE
INDIA S
823 NDA/MAL/H UNI MEDICO SHREEJI UCLOX CLOXACILLIN 500MG UNI MEDICOLABS.- 21-22 INDIA PARENTERAL 1.0X500.0 7/1/2015
DP/1584 LAB PHARMACEUTIC SODIUM PHARMACITY SELAQUI ORDINARY MG VIAL
ALS LIMITED DEHRADUN 248197 DRY VIALS
824 NDA/MAL/H WIN- SURGIPHARM UDIHEP URSODEOXYC 300MG WIN-MEDICARE PRIVATE INDIA ORAL SOLID 1.0X5.0X1 7/1/2010
DP/1585 MEDICARE (U) LIMITED FORTE HOLIC ACID LIMITED-MEERUT- ORDINARY 0.0
PVT LTD MUZAFFARNAGAR ROAD, TABLETS TABLET
MODIPURAM - 250110 BLISTER
UTTAR PRADESH
825 NDA/MAL/H TORRENT KARURI TOZAAR-H LOSARTAN 50MG + TORRENT INDIA ORAL SOLID 1.0X10.0X 7/1/2005
DP/1588 PHARAMACE PHARMACEUTIC POTASSIUM + 12.5MG PHARMACEUTICALS ORDINARY 10.0
UTICALS LTD ALS LTD. HYDROCHLOR LIMITED -AHMEDABAD- FILM- TABLET
OTHIAZIDE MEHSANA HIGHWAY, TAL. COATED STRIP,1.0X
KADI, DIST. MEHSANA, TABLETS 4.0X7.0
INDRAD 382 721, GUJARAT TABLET
BLISTER
826 NDA/MAL/H CENTAUR GITTOES CENTACID MAGNESIUM 40MG+200 CENTAUR INDIA ORAL LIQUID 1.0X100.0 7/1/1997
DP/1589 PHARMACEUT PHARMACEUTIC SUSPENSIO HYDROXIDE + MG+250M PHARMACEUTICALS PVT ORDINARY ML
ICALS PVT LTD ALS LIMITED N ALUMINIUM G/5ML LTD-PLOT NO.3 TIVIN SUSPENSION BOTTLE,1.
HYDROXIDE+S INDUSTRIAL ESTATE S 0X200.0
IMETHICONE KARASWADA 403526 ML
INDIA BOTTLE,1.
0X170.0
ML
BOTTLE
827 NDA/MAL/H CENTAUR GITTOES CENTIPAR PIPERAZINE 750ML/5M CENTAUR INDIA ORAL LIQUID 1.0X30.0 7/1/1997
DP/1591 PHARMACEUT PHARMACEUTIC ELIXIR CITRATE L PHARMACEUTICALS PVT ORDINARY ML
ICALS LTD ALS LIMITED LTD-PLOT NO.3 TIVIN LIQUIDS BOTTLE
INDUSTRIAL ESTATE
KARASWADA 403526
INDIA
828 NDA/MAL/H GITTOES GITTOES AGOCIM CIMETIDINE 400MG AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1.0X10.0X 7/1/2005
COATED BLISTER
TABLETS
829 NDA/MAL/H RENE RENE ASPIRIN ACETYL 300MG RENE INDUSTRIES LTD- UGANDA ORAL SOLID 1.0X500.0 7/1/2001
DP/1605 INDUSTRIES INDUSTRIES TABLETS SALICYLIC PLOT 680, KAMULI ROAD, ORDINARY TABLET
LIMITED LIMITED ACID KIREKA, P.O BOX 6034, TABLETS CONTAIN
KAMPALA ER
830 NDA/MAL/H ASTRA LIFE ASTRA PHARMA ASTAGRA- SILDENAFIL 50MG ASTRA LIFE CARE (INDIA) INDIA ORAL SOLID 1.0X10.0X 7/1/2011
DP/1614 CARE (INDIA) (U) LIMITED 50 PVT LIMITED-57/P RAJODA ORDINARY 1.0X4.0
PVT LTD 382220 BAVIA TABLETS TABLET
AHMEDABAD INDIA BLISTER
831 NDA/MAL/H AJANTA ABACUS APCALIS SX TADALAFIL 20MG AJANTA PHARMA LIMITED INDIA ORAL SOLID 1.0X2.0X2 7/1/2005
DP/1615 PHARMA LTD PHARMA PAITHAN- ORDINARY .0 TABLET
(AFRICA) MANUFACTURING UNIT B- FILM- BLISTER
LIMITED 4/5/6 MIDC PAITHAN COATED
DISTRICT AURANGABAD TABLETS
431 148 MAHARASTRA
STATE INDIA
832 NDA/MAL/H GITTOES GITTOES CEZIN CETIRIZINE 5MG/5ML AGOG PHARMA LTD-PLOT INDIA ORAL LIQUID 1.0X100.0 7/1/2011
DP/1616 PHARMACEUT PHARMACEUTIC NO.33,SECTOR ORDINARY ML
ICALS LIMITED ALS LIMITED II,VASAI,TALUKA INDL CO- SYRUPS BOTTLE,1.
PADA,VASAI(E)DIST.THAN BOTTLE,1.
E INDIA 0X60.0 ML
BOTTLE
833 NDA/MAL/H DAR AL DAWA GAMA AMOXYDAR AMOXYCILLIN 125MG/5 DAR AL DAWA-NA'UR JORDAN ORAL LIQUID 1.0X100.0 7/1/2009
DP/1618 DEVELOPMEN PHARMACEUTIC TRIHYDRATE ML PLANT AMMAN ORDINARY ML
T AND ALS (U) LIMITED DRY BOTTLE
INVESTMENT SUSPENSION
CO LTD S/SYRUPS/D
ROPS
834 NDA/MAL/H GLENMARK STAR CANDID-V CLOTRIMAZO 2%W/W GLENMARK INDIA VAGINAL 1.0X30.0 7/1/2004
DP/1627 PHARMACEUT PHARMACEUTIC GEL LE PHARMACEUTICALS LTD- GELS AND G TUBE
ICAL LTD ALS LTD PLOT NO E -37, 39 ,D SOLS
835 NDA/MAL/H INTAS NORVIK CARVETAS CARVEDILOL 12.5MG QIAGEN GMBH-SELAQUI INDIA ORAL SOLID 1.0X3.0X1 7/1/2011
DP/1629 PHARMACEUT ENTERPRISES 12.5 DEHRADUN 248197 ORDINARY 0.0
ICALS LTD LIMITED TABLETS TABLET
BLISTER
836 NDA/MAL/H AUROBINDO GITTOES NEVIRAPIN NEVIRAPINE 50MG/5ML AUROBINDO PHARMA INDIA ORAL LIQUID 1.0X240.0 7/1/2007
DP/1631 M PHARMA PHARMACEUTIC E ORAL LTD, UNIT III -SURVEY NO. ORDINARY ML
LIMITED ALS LIMITED SUSPENSIO 313, 314 BACHUPALLY SUSPENSION BOTTLE,1.
N (VILLAGE) S 0X100.0
QUTHUBULLAPUR ML
(MANDAL) RR DISTRICT BOTTLE
HYDERABAD ANDHRA
PRADESH 500090
837 NDA/MAL/H CADILA ESCORTS ORITAXIM CEFOTAXIME 1GM CADILA INDIA PARENTERAL 1.0X1.0 G 7/1/1997
DP/1635 PHARMACEUT PHARMACEUTIC 1000MG SODIUM PHARMACEUTICALS ORDINARY VIAL
ICALS LIMITED ALS LIMITED INJECTION LIMITED-1389, TRASAD VIALS
STATE, INDIA
838 NDA/MAL/H NORVATIS LABOREX VIGAMOX MOXIFLOXACI 5MG/ML S.A.ALCON COUVREUR N.V- BELGIUM OPHTHALMI 1.0X5.0 7/1/2013
DP/1636 PHARMA AG- UGANDA N RIJKSWEG 14, B-2870 C DROPS ML
SWITZERLAN LIMITED PUURS BELGIUM BOTTLE
D
839 NDA/MAL/H AMOUN WIDE FLADAZOLE SECNIDAZOLE 500MG AMOUN EGYPT ORAL SOLID 1.0X4.0 7/1/2005
DP/1638 PHARMACEUT SPECTRUM PHARMACEUTICALS CO. ORDINARY TABLET
ICAL ENTERPRISES S.A.E-1ST INDUSTRIAL TABLETS BLISTER
COMPANY (U) LIMITED ZONE, EL-OBOUR CITY,
EGYPT.
840 NDA/MAL/H GLAXO UNITED PANADOL PARACETAM 500MG + GLAXOSMITHKLINE KENYA ORAL SOLID 1.0X2.0X1 7/1/2003
DP/1639 SMITHLINE HEALTHCARE EXTRA OL + 65MG LIMITED - -78392-00507, ORDINARY 0.0
LIMITED DISTRIBUTORS WITH CAFFEINE VIWANDANI LIKONI ROAD TABLETS TABLET
LTD OPTIZORB NAIROBI KENYA BLISTER,1.
0X10.0X10
.0 TABLET
BLISTER,1.
0X100.0
TABLET
CARTON
841 NDA/MAL/H GLAXOSMITH UNITED ALBEN ALBENDAZOL 400MG MEDREICH LIMITED - UNIT INDIA ORAL SOLID 1.0X1.0 7/1/1999
DP/1640 KLINE HEALTHCARE TABLETS E 3-SURVEY NO. 4/3, ORDINARY TABLET
PHARMACEUT DISTRIBUTORS AVALAHALLI, TABLETS BLISTER,1.
ICAL KENYA LTD ANJANAPURA, OFF 0X10.0
LTD KANAKAPURA ROAD, TABLET
BANGALORE-560062 BLISTER,1.
0X500.0
TABLET
BLISTER
842 NDA/MAL/H UNICHEM PHILLIPS UNIENZYM NICOTINAMI 25MG+50 UNICHEM LABORATORIES INDIA ORAL SOLID 1.0X10.0X 7/1/2004
DP/1641 LABORATORIE PHARMACEUTIC E C MPS DE+SIMETHIC MG+30MG LTD---C31 & 32 ORDINARY 10.0
S LTD ALS (UGANDA) ONE+PAPAIN +20MG+75 INDUSTRIAL AREA TABLETS TABLET
LIMITED +FUNGAL MG STRIP
DIASTASE+CH
ARCOAL
843 NDA/MAL/H UMEDICA VITACARE EUCHLOR- CHLORAMPH 1G UMEDICA LABORATORIES INDIA PARENTERAL 1.0X1.0 G 7/1/2004
DP/1642 LABORATORIE LIMITED 1000 ENICOL PVT LTD-PLOT NO. 221, ORDINARY VIAL
S PVT LTD SODIUM 2ND PHASE, GIDC, VAPI VIALS
SUCCINNATE 396195, GUJARAT. INDIA.
B.P
844 NDA/MAL/H ASTRA ASTRA PHARMA ASTAZOLE MEBENDAZOL 100MG ASTRA LIFE CARE (INDIA) INDIA ORAL SOLID 1.0X10.0X 7/1/1997
DP/1645 PHARMA (U) (U) LIMITED E PVT.LTD-PLOT 57/P, ORDINARY 10.0
LIMITED RAJODA-382220, BAVLA CHEWABLE TABLET
AHMEDABAD, INDIA TABLETS BLISTER,1.
0X1000.0
TABLET
CONTAIN
ER
845 NDA/MAL/H BETA BETA BETROZOLE METRONIDAZ 200MG+25 BETA HEALTHCARE KENYA ORAL SOLID 1.0X30.0 7/1/2002
DP/1646 HEALTHCARE HEALTHCARE TABLETS OLE+DILOXAN 0MG INTERNATIONAL LTD - - ORDINARY TABLET
INTERNATION UGANDA IDE PLOT TABLETS BLISTER
AL LTD LIMITED NO.209/6554,MOGADISHU
ROAD,OFF LUNGA LUNGA
INDUSTRIAL AREA,
P.O.BOX 42569-001000
NAIROBI,KENYA
846 NDA/MAL/H NOVARTIS SURGIPHARM TEGRETOL CARBAMAZEP 200MG NOVARTIS FARMA S.P.A.- ITALY ORAL SOLID 1.0X5.0X1 7/1/2006
DP/1650 PHARMA AG (U) LIMITED CR 200 INE VIA PROVINCIALE SCHITO RETARD 0.0
131, 80058 TORRE TABLETS TABLET
ANNUNZIATA, ITALY BLISTER
847 NDA/MAL/H TORRENT KARURI VALPARIN SODIUM 300MG TORRENT INDIA ORAL SOLID 1.0X10.0X 7/1/2009
DP/1652 PHARAMACE PHARMACEUTIC CHRONO VALPROATE PHARMACEUTICAL LTD- ORDINARY 10.0
UTICALS LTD ALS LTD. 300 AHMEDABAD-MEHSANA FILM- TABLET
HIGHWAY,TALUKA- COATED STRIP
KADI,DIST.MEHSANA,INDR TABLETS
AD-382721
848 NDA/MAL/H UNIVERSAL HARLEYS UNIGENTYL SECNIDAZOLE 500MG UNIVERSAL CORPORATION KENYA ORAL SOLID 1.0X1.0X4 7/1/2010
DP/1655 CORPORATIO UGANDA LIMITED -PLOT 13777 ORDINARY .0 TABLET
N LTD LIMITED KIKUYU ROAD, KIKUYU FILM- BLISTER
TOWN, PAST POST OFFICE COATED
TABLETS
849 NDA/MAL/H ANHIU MAISHA AZIGYL-500 AZITHROMYCI 500MG MEDICO REMEDIES PVT INDIA ORAL SOLID 1.0X10.0 7/1/2015
DP/1656 MEDICAL N LIMITED-8 & 9 DEWAN & ORDINARY TABLET
SUPPLIES SONS, UDYOG NAGAR FILM- BLISTER,1.
LIMITED PALGAR, DISTRICT THANE COATED 0X3.0
MAHARASHTRA, INDIA TABLETS TABLET
BLISTER
850 NDA/MAL/H GITTOES GITTOES AGOCIM- CIMEDITINE 200MG AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1.0X10.0X 7/1/2005
BLISTER,1.
0X1000.0
TABLET
CONTAIN
ER,1.0X10
0.0X10.0
TABLET
STRIP
851 NDA/MAL/H ABBVIE (PTY) MEDICAL ALUVIA LOPINAVIR/ 100MG/25 ABBVIE DEUTSCHLAND GERMANY ORAL SOLID 1.0X60.0 7/1/2007
DP/1661 LTD ACCESS 100/25 RITONAVIR MG GMBH & CO. KG.- ORDINARY TABLET
(UGANDA) KNOLLSTASSE 50, D-67061, FILM- CONTAIN
LIMITED LUDWIGSHAFEN, COATED ER
GERMANY. TABLETS
852 NDA/MAL/H MACK SHURIK LTD ALCID-PINK ALUMINIUM 400MG+40 TORQUE INDIA ORAL LIQUID 1.0X400.0 7/1/2003
DP/1663 BROWN HYDROXIDE/ 0MG/50ML PHARMACEUTICALS PVT ORDINARY ML
PHARMECEUT MAGNESIUM LTD-ISAAPUR P.O DAPPAR SUSPENSION BOTTLE,1.
ICALS PVT LTD TRISILICATE 140056 INDIA S 0X160.0
ML
BOTTLE
853 NDA/MAL/H GITTOES GITTOES AGOXIN AMOXICILLIN 250MG MILAN LABORATORIES INDIA ORAL SOLID 1.0X100.0 7/1/1998
DP/1665 PHARMACEUT PHARMACEUTIC CAPSULES TRIHYDRATE (INDIA ) PVT LTD-PLOT NO ORDINARY X10.0
ICALS LIMITED ALS LIMITED 63/67/87 J.C.I.E LTD CAPSULES CAPSULE
KAMOTHE PANVER, NAVI BLISTER,1.
MUMBAI,INDIA 0X1000.0
CAPSULE
CONTAIN
ER,1.0X10
.0X10.0
CAPSULE
BLISTER
854 NDA/MAL/H SANOFI SURGIPHARM AMARYL 1 GLIMEPIRIDE 1MG SANOFI AVENTIS-2 BOND SOUTH ORAL SOLID 1.0X3.0X1 7/1/2005
DP/1666 AVENTIS (U) LIMITED STREET MIDRAND 1685 AFRICA ORDINARY 0.0
SOUTH AFRICA TABLETS TABLET
BLISTER
855 NDA/MAL/H SANOFI SURGIPHARM AMARYL 2 GLIMEPIRIDE 2MG AVENTIS PHARMA- SOUTH ORAL SOLID 1.0X3.0X1 7/1/2005
DP/1669 AVENTIS (U) LIMITED AVENTIS PHARMA, 315 AFRICA ORDINARY 0.0
WALTLOO ROAD, TABLETS TABLET
SILVERTON 0127 BLISTER
PRETORIA
856 NDA/MAL/H SANOFI SURGIPHARM AMARYL 4 GLIMIPIRIDE 4MG AVENTIS PHARMA- SOUTH ORAL SOLID 1.0X3.0X1 7/1/2005
DP/1670 AVENTIS (U) LIMITED AVENTIS PHARMA, 315 AFRICA ORDINARY 0.0
WALTLOO ROAD, TABLETS TABLET
SILVERTON 0127 BLISTER
PRETORIA
857 NDA/MAL/H GLAXOSMITH UNITED AMOXIL AMOXYCILLIN 250MG GLAXO WELLCOME FRANCE ORAL SOLID 10.0X10.0 7/1/2005
DP/1673 KLINE HEALTHCARE PRODUCTION -Z.I DE LA ORDINARY CAPSULE
PHARMACEUT DISTRIBUTORS PEYENNIERE 53100 CAPSULES BLISTER
ICAL KENYA LTD MAYENNE FRANCE
LTD
858 NDA/MAL/H KOPRAN TATA UGANDA CLOXIN-250 CLOXACILLIN 250MG KOPRAN LTD-VILLAGE INDIA ORAL SOLID 1.0X100.0 7/1/1997
DP/1676 LIMITED LIMITED SAVROLI TAL KHARAPUR ORDINARY CAPSULE
DIST RAIGAD 410 202 CAPSULES CONTAIN
ER,1.0X10
00.0
CAPSULE
CONTAIN
ER,1.0X10
.0X10.0
CAPSULE
BLISTER
859 NDA/MAL/H SHOSAAN RENE H-CORT HYDROCORTI 0.1%W/W NEM LABORATORIES PVT INDIA TOPICAL 1.0X15.0 7/1/1997
DP/1680 ASIC PACIFIC PHARMACY LTD SONE LTD-133 VASAI RD(E) 401 EXTERNAL G TUBE
162 SB MARG. LOWER CREAMS
PAREL MUMBAI
860 NDA/MAL/H CADILA ABACUS LOSACAR LOSARTAN 25MG CADILA HEALTH CARE LTD- INDIA ORAL SOLID 1.0X10.0X 7/1/2003
DP/1681 HEALTHCARE PHARMA 25 POTASSIUM KUNDAIM INDUSTRIAL ORDINARY 7.0
LTD (AFRICA) ESTATE, PLOT NO. 203- TABLETS TABLET
LIMITED 213, KUNDAIM,GOA-403 BLISTER,1.
115, INDIA 0X10.0X10
.0 TABLET
BLISTER
861 NDA/MAL/H VIRBAC RSA METRO TOFLOX- OFLOXACIN 200MG LINCOLN INDIA ORAL SOLID 1.0X1.0X1 7/1/2005
DP/1682 (PTY) LTD PHARMACEUTIC 200 PHARMACEUTICAL ORDINARY 0.0
ALS LIMITED LIMITED-TRIMAL ESTATE TABLETS TABLET
KHATRAJ KOLOL,GUJARAT BLISTER,1.
INDIA 0X10.0X1.
0X10.0
TABLET
BLISTER
862 NDA/MAL/H LINCOLN METRO QUININE QUININE 300MG LINCOLN INDIA ORAL SOLID 1.0X1000. 7/1/2005
DP/1686 PHARMACEUT PHARMACEUTIC SULPHATE SULPHATE PHARMACEUTICALS LTD- ORDINARY 0 TABLET
ICALS LTD ALS LIMITED 10, 11, 13, TRIMUL ESTATE COATED CONTAIN
KHATRAJ, NEAR TABLETS ER,1.0X10
KHATRAJ, CHOKADI , 0.0
KHATRAJ-382721, TABLET
GHANDINAGARGUJARAT, CONTAIN
INDIA ER,1.0X10
.0X10.0
TABLET
BLISTER
863 NDA/MAL/H SK AGE ABACUS OMESK OMEPRAZOLE 20MG S.KANT HEALTHCARE LTD- INDIA ORAL SOLID 1.0X10.0X 7/1/2010
DP/1689 EXPORTS PHARMA PLOT 1802, 1805, GIDC ORDINARY 10.0
(AFRICA) PHASE III VAPI 39179, CAPSULES CAPSULE
LIMITED GUJARAT STRIP
864 NDA/MAL/H PHARMA OMAB UGANDA FINALLERG CETIRIZINE 1MG/ML PHARMA INTERNATIONAL JORDAN ORAL LIQUID 1.0X100.0 7/1/2004
DP/1690 INTERNATION LIMITED DIHYDROCHL COMPANY-MAIN STREET, ORDINARY ML
AL CO ORIDE AL QASTAL INDUSTRIAL SYRUPS BOTTLE
AREA AMMAN- JORDAN
JORDAN
865 NDA/MAL/H WIDE WIDE ZITHRORIV AZITHROMYCI 500MG RIVA PHARMA FREE ZONE- EGYPT ORAL SOLID 1.0X3.0 7/1/2011
DP/1691 SPECTRUM SPECTRUM N NASR CITY CAIRO EGYPT ORDINARY CAPSULE
ENTERPRISES ENTERPRISES CAPSULES BLISTER
(U) LIMITED (U) LIMITED
866 NDA/MAL/H PHARMA OMAB UGANDA CEFODOX CEFPODOXIM 50MG/5ML PHARMA INTERNATIONAL JORDAN ORAL LIQUID 1.0X50.0 7/1/2007
DP/1692 INTERNATION LIMITED 50MG/5ML E PROXETIL CO.,-AL-QASTAL AREA, ORDINARY ML
AL CO SUSPENSIO AIRPORT ROAD, 11941, DRY BOTTLE
N AMMAN SUSPENSION
S/SYRUPS/D
ROPS
867 NDA/MAL/H PHARMA OMAB UGANDA OPTIMAL TRETINOIN 0.5MG/1G PHARMA INTERNATIONAL JORDAN TOPICAL 1.0X1.0X3 7/1/2005
DP/1693 INTERNATION LIMITED (0.05%) USP COMPANY .-MAIN STREET, EXTERNAL 0.0 G
AL COMPANY CREAM AL QASTAL INDUSTRIAL CREAMS TUBE
AREA AMMAN- JORDAN
868 NDA/MAL/H PHARMA OMAB UGANDA FINALLERG CETIRIZINE 10MG PHARMA INTERNATIONAL JORDAN ORAL SOLID 1.0X10.0 7/1/2005
DP/1697 INTERNATION LIMITED DIHYDROCHL COMPANY-MAIN STREET, ORDINARY TABLET
AL CO ORIDE AL QASTAL INDUSTRIAL FILM- BLISTER
AREA AMMAN- JORDAN COATED
JORDAN TABLETS
869 NDA/MAL/H CIPLA LTD QUALITY AZEE-500 AZITHROMYCI 500MG CIPLA LTD.-VERNA IND. INDIA ORAL SOLID 1.0X10.0X 7/1/2009
DP/1698 CHEMICALS LTD - N ESTATE GOA 403 722 ORDINARY 1.0X3.0
HUMAN INDIA FILM- TABLET
COATED BLISTER
TABLETS
870 NDA/MAL/H KAMPALA KAMPALA FORMIN METFORMIN 500MG KAMPALA UGANDA ORAL SOLID 1.0X10.0X 7/1/2014
DP/1701 PHARMACEUT PHARMACEUTIC HYDROCHLOR PHARMACEUTICAL ORDINARY 10.0
ICAL AL INDUSTRIES IDE INDUSTRIES (1996) FILM- TABLET
INDUSTRIES 1996 LIMITED LIMITED - -STRETCHER COATED BLISTER
(1996) LTD ROAD PLOT M444B TABLETS
NTINDA KAMPALA
871 NDA/MAL/H PHARMA OMAB UGANDA DELOR CLOBETASOL 0.05%W/W PHARMA INTERNATIONAL JORDAN TOPICAL 1.0X25.0 7/1/2005
DP/1702 INTERNATION LIMITED PROPIONATE COMPANY-MAIN STREET, EXTERNAL G TUBE
AL COMPANY AL QASTAL INDUSTRIAL OINTMENTS
AREA AMMAN- JORDAN
JORDAN
872 NDA/MAL/H XEPA SOUL DELMAW FEBRICOL PARACETAM 500MG / XEPA-SOUL PATTINSON MALAYSIA ORAL SOLID 1.0X10.0X 7/1/1997
DP/1707 PATTISON (M) ENTERPRISES TABLETS OL / 30MG (MALAYSIA) SDN BLD -1-5 ORDINARY 10.0
SDN BHD LIMITED PSEUDOEPHE /2MG CHENG INDUSTRIAL TABLETS TABLET
DRINE / ESTATE, 75250 BLISTER,1.
CHLORPHENI MALEKA, MALAYSIA 0X2.0X10.
RAMINE 0 TABLET
BLISTER
873 NDA/MAL/H LABORATORY HARLEYS DENTAMOL ACETAMINOP 500MG LABORATORY & ALLIED KENYA ORAL SOLID 1.0X2.0X1 7/1/1997
DP/1708 AND ALLIED UGANDA HEN LTD-PLOT NO. 209/10349 ORDINARY 0.0
LTD LIMITED OFF MOMBASA ROAD, TABLETS TABLET
NAIROBI BLISTER
P.O. BOX 42875, NAIROBI,
KENYA.
874 NDA/MAL/H REGAL REGAL PHARMA LUCIN HYDROCORTI 1%W/W REGAL KENYA TOPICAL 1.0X10.0 7/1/1997
DP/1709 PHARMACEUT (U) LTD CREAM SONE PHARMACEUTICALS LTD- EXTERNAL G
ICALS LTD BABA DOGO ROAD, CREAMS TUBE,1.0X
RAURAKA,NAIROBI,KENYA 15.0 G
TUBE,1.0X
5.0 G
TUBE
875 NDA/MAL/H KOPRAN TATA UGANDA AMYN-250 AMOXYCILLIN 250MG KOPRAN LIMITED-VILLAGE- INDIA ORAL SOLID 10.0X10.0 7/1/1997
DP/1711 LIMITED LIMITED SAVROLI (KHOPOLI), ORDINARY CAPSULE
TALUKA- KHALAPUR, DIST. CAPSULES BLISTER,1.
RAIGAD, MAHARASHTRA, 0X1000.0
INDIA CAPSULE
CONTAIN
ER
876 NDA/MAL/H MACLEODS NORVIK LUMITER ARTEMETHER 20 MG + MACLEODS INDIA ORAL SOLID 1.0X3.0X8 7/1/2007
DP/1713 PHARMACEUT ENTERPRISES + 120 MG PHARMACEUTICALS LTD - ORDINARY .0 TABLET
ICALS LTD LIMITED LUMEFANTRI BLOCK N2, VILLAGE TABLETS BLISTER,1.
NE THEDA, P.O. LODHI 0X1.0X6.0
MAJRA, TEHSIL BADDI, TABLET
DIST. SOLAN, HIMACHAL BLISTER,1.
PRADESH 174101 OXALIS 0X1.0X24.
LABS -VILLAGE THEDA P.O 0 TABLET
LODHIMAJRA, THESIL BLISTER,1.
BADDI DISTRICT SOLAN 0X30.0X12
HIMACHAL PRADESH .0 TABLET
BLISTER,1.
877 NDA/MAL/H SHELYS BETA MUCOLYN AMMONIUM 50MG+2M BETA HEALTHCARE TANZANIA ORAL LIQUID 1.0X1.0X1 7/1/1997
DP/1715 PHARMACEUT HEALTHCARE SYRUP CHLORIDE+C G+5MG+4 INTERNATIONAL LTD - - ORDINARY 00.0 ML
ICALS LTD UGANDA HLORPHENIR MG PLOT SYRUPS BOTTLE
LIMITED AMINE+DEXT NO.209/6554,MOGADISHU
ROMETHORP ROAD,OFF LUNGA LUNGA
HAN+BROMH INDUSTRIAL AREA,
EXINE P.O.BOX 42569-001000
NAIROBI,KENYA SHELYS
PHARMACEUTICALS LTD,-
NEW BAGAMOYO ROAD,
MWENGE, PLOT NO
696,BLOCK NO 32,
878 NDA/MAL/H NIRMA LIFE PHARMA NIRMIN 5S MULTI- MULTI- ACULIFE HEALTH CARE, INDIA PARENTERAL 1.0X500.0 7/1/2010
DP/1716 LIMITED AFRICA LIMITED INGREDIENT INGREDIEN FORMALLY ORDINARY ML
(HEALTHCARE T NIRMA(HEALTHCARE INFUSION BOTTLE
DI VISION) DIVISION)-VILLAGE: DRY
NIRLIFE SACHANA, TALUKA: VIALS/BOTTL
HEALTHCARE VIRAMGAM DISTRICT: ES
AHMEDABAD-382150
GUJARAT, INDIA
879 NDA/MAL/H NIRMA LIFE PHARMA NIRMIN 10 MULTI- MULTI- ACULIFE HEALTH CARE, INDIA PARENTERAL 1.0X500.0 7/1/2010
DP/1719 LIMITED AFRICA LIMITED PLUS INGREDIENT INGREDIEN FORMALLY ORDINARY ML
(HEALTHCARE T NIRMA(HEALTHCARE INFUSION BOTTLE
DI VISION) DIVISION)-VILLAGE: VIALS/BOTTL
NIRLIFE SACHANA, TALUKA: ES
HEALTHCARE VIRAMGAM DISTRICT:
AHMEDABAD-382150
GUJARAT, INDIA
880 NDA/MAL/H USV PRIVATE ABACUS GROVIT MULTI- MULTI- SAKAR HEALTHCARE PVT INDIA ORAL LIQUID 1.0X15.0 7/1/2000
DP/1723 LIMITED PHARMA MULTIVITA INGREDIENT INGREDIEN LTD-SAKAR HEALTHCARE ORDINARY ML
(AFRICA) MIN DROPS T PVT LTD, BLOCK NO 10-13, DROPS BOTTLE
LIMITED M.N. DESA
881 NDA/MAL/H GLAXOSMITH UNITED AVAMYS FLUTICASONE 27.5MCG/ GLAXO OPERATIONS UK UNITED NASAL 1.0X120.0 7/1/2009
DP/1724 KLINE LTD HEALTHCARE NASAL FUROATE ACTUATIO LTD---HARMIRE ROAD, KINGDOM TOPICAL METERED
DISTRIBUTORS SPRAY N BARNARD CASTLE, SPRAYS DOSE
LTD DURHAM DL128 DT UK WITHOUT CANNISTE
GAS R
882 NDA/MAL/H REMEDICA GOODMAN MYCORIL CLOTRIMAZO 1%W/W REMEDICA LIMITED- CYPRUS TOPICAL 1.0X20.0 7/1/2000
DP/1725 LTD INTERNATIONAL CREAM 1% LE LIMASSOL INDUSTRIAL EXTERNAL G TUBE
LTD ESTATE, AHAR CREAMS
883 NDA/MAL/H GLAXOSMITH UNITED HAVRIX 720 INACTIVATED 720 ELISA SMITHKLINE BEECHAM BELGIUM PARENTERAL 1.0X0.5 7/1/1997
DP/1726 KLINE HEALTHCARE HEPATITIS A UNITS BIOLOGICALS , BELGIUM- ORDINARY ML VIAL
PHARMACEUT DISTRIBUTORS VIRUS ADSORBED BELGIUM VIALS (1 DOSE)
ICAL KENYA LTD ADSORBED ON
LTD ON 0.25MG
ALUMINIUM ALUMINIU
HYDROXIDE M
HYDRATED HYDROXID
E
884 NDA/MAL/H MISSION JOINT MEDICAL TETRACYCLI TETRACYCLIN 3%W/W NANJING BAIJINGYN CHINA TOPICAL 1.0X15.0 7/1/2014
DP/1727 PHARMA STORE (UPMB - NE E PHARMACEUTICALS EXTERNAL G TUBE
UCMB) HYDROCLO HYDROCHLOR CO.LTD NO-1 HUIZHONG OINTMENTS
RIDE IDE ROAD NANJING
ECONOMIC AND
TECHNICAL
DEVELOPMENT ZONE
885 NDA/MAL/H ARISTO NORVIK DELISPRIN ASPIRIN 75MG ARISTO INDIA ORAL SOLID 1.0X10.0X 7/1/2007
DP/1728 PHARMACEUT ENTERPRISES 75MG PHARMACEUTICALS PVT ORDINARY 10.0
ICALS LTD LIMITED LTD -PLOT NO 208 NEW ENTERIC- TABLET
INDUSTRIAL GREEN NO2 COATED STRIP,1.0X
MANDIDEED 462046 TABLETS 10.0X14.0
TABLET
STRIP
886 NDA/MAL/H COSMOS LTD ASTRA PHARMA ZITHROX AZITHROMYCI 500MG COSMOS LTD.-RANGWE KENYA ORAL SOLID 1.0X3.0 7/1/2008
DP/1730 (U) LIMITED N ROAD; OFF LUNGA LUNGA ORDINARY TABLET
ROAD. P.O BOX 414 33, TABLETS BLISTER
NAIROBI
887 NDA/MAL/H REGAL REGAL PHARMA MEDIVEN-S BETAMETHAS 0.05%W/W REGAL KENYA TOPICAL 1.0X15.0 7/1/1997
DP/1731 PHARMACEUT (U) LTD OINTMENT ONE + 3%W/W PHARMACEUTICALS LTD- EXTERNAL G TUBE
ICALS LTD VALERATE + BABA DOGO ROAD, OINTMENTS
SALICYLIC RAURAKA,NAIROBI,KENYA
ACID
888 NDA/MAL/H MICRO LABS LABOREX CEFEX-250 CEPHALEXIN 250MG MICROLABS LIMITED-PLOT INDIA ORAL SOLID 1.0X10.0X 7/1/1999
DP/1732 LTD UGANDA NO. 121-124, KIADB, ORDINARY 10.0
LIMITED BOMMASANDRA , -JIGNI CAPSULES CAPSULE
LINK ROAD, ANEKUL BLISTER
TALUK,BANGALORE,
KARNATAKA, INDIA
889 NDA/MAL/H KAMPALA KAMPALA KAMOMINT COMPOUND 500MG TIL HEALTH CARE-PLOT INDIA ORAL SOLID 10.0 7/1/1997
DP/1734 PHARMACEUT PHARMACEUTIC MAGNESIUM 100,WEST,R- ORDINARY TABLET
ICAL AL INDUSTRIES TRISILICATE 5,SOUTH;SRICITY CHEWABLE CONTAIN
INDUSTRIES 1996 LIMITED SEZ,CHERIVI,IRUHULAM,PS TABLETS ER,250.0
(1996) LTD OT,SATYAVEDU TABLET
MANDAL,CHITOOR CONTAIN
DISTRICT-ANDRA ER,500.0
PRADESH-517588, INDIA TABLET
CONTAIN
ER,100.0
TABLET
CONTAIN
890 NDA/MAL/H MEDOCHEMIE BOOTS KLERIMED CLARITHROM 500MG MEDOCHEMIE LTD-1-10 CYPRUS ORAL SOLID 1.0X2.0X7 7/1/2009
DP/1736 LTD PHARMACEUTIC YCIN CONSTANTINOUPOLEOS ORDINARY .0 TABLET
ALS LIMITED TREET 3011 LIMASSOL TABLETS BLISTER
891 NDA/MAL/H ALCON KARURI TEARS NATURAL 15ML ALCON COUVREUR NV- BELGIUM OPHTHALMI 1.0X15.0 7/1/1997
DP/1738 PHARMACEUT PHARMACEUTIC NATURALE TEARS RIJKSWEG 14, B-2870 C DROPS ML
ICALS ALS LTD. II PUURS BELGIUM BOTTLE
892 NDA/MAL/H AMMAN WIDE NEOPRED-P PREDNISOLO 5MG/ML AMMAN JORDAN OPHTHALMI 1.0X1.0X1 7/1/2005
DP/1741 PHARMACEUT SPECTRUM NE ACETATE +5MG/ML PHARMACEUTICALS C DROPS 0.0 ML
ICAL ENTERPRISES + NEOMYCIN + 1M INDUSTRIES .-KING VIAL
INDUSTRIES (U) LIMITED SULPHATE+ I.U/ML ABDULLAH II, INDUSTRIAL
POLYMYXIN-B ESTATE,SAHAB, AMMAN,
JORDAN
893 NDA/MAL/H MEDOCHEMIE BOOTS DAPRIL LISINOPRIL 10MG MEDOCHEMIE LTD-1-10 CYPRUS ORAL SOLID 1.0X3.0X1 7/1/2009
DP/1743 LTD PHARMACEUTIC DIHYDRATE CONSTANTINOUPOLEOS ORDINARY 0.0
ALS LIMITED TREET 3011 LIMASSOL TABLETS TABLET
BLISTER
894 NDA/MAL/H AMMAN WIDE APIGEN GENTAMYCIN 0.3%W/V AMMAN JORDAN OPHTHALMI 1.0X1.0X1 7/1/2005
DP/1745 PHARMACEUT SPECTRUM SULPHATE PHARMACEUTICALS C DROPS 0.0 ML
ICAL ENTERPRISES INDUSTRIES-AMMAN VIAL
INDUSTRIES (U) LIMITED PHARMACEUTICAL
INDUSTRIES-KING
ABDULLAH II, INDUSTRIAL
ESTATE,SAHAB, AMMAN,
JORDAN
895 NDA/MAL/H IPCA MEDVIN PRESARTAN LOSARTAN 50MG + IPCA LABORATORIES LTD- INDIA ORAL SOLID 1.0X2.0X1 7/1/2008
DP/1747 LABORATORIE PHARMA H 50 POTASSIUM + 12.5MG PLOT NO. 255/1, ORDINARY 4.0
S LTD LIMITED HYDROCHLOR VILLAGE ATHAL, FILM- TABLET
OTHIAZIDE SILVASSA-396230, COATED BLISTER,1.
DADRA AND NAGAR TABLETS 0X10.0X10
BLISTER
896 NDA/MAL/H GITTOES GITTOES AZ-500 AZITHROMYCI 500MG AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1.0X3.0 7/1/2011
DP/1748 PHARMACEUT PHARMACEUTIC N NO.33,SECTOR ORDINARY CAPSULE
ICALS LIMITED ALS LIMITED II,VASAI,TALUKA INDL CO- CAPSULES BLISTER
E INDIA
897 NDA/MAL/H AMMAN WIDE APIFLOX NORFLOXACI 0.3%W/V AMMAN JORDAN OPHTHALMI 1.0X1.0X1 7/1/2005
DP/1750 PHARMACEUT SPECTRUM N PHARMACEUTICALS C DROPS 0.0 ML
ICAL ENTERPRISES INDUSTRIES-AMMAN VIAL
INDUSTRIES-KING
JORDAN
898 NDA/MAL/H AMMAN WIDE OPTIFUCIN FUSIDIC ACID 1%W/V AMMAN JORDAN OPHTHALMI 1.0X5.0 7/1/2005
DP/1751 PHARMACEUT SPECTRUM PHARMACEUTICALS C DROPS ML
ICAL ENTERPRISES INDUSTRIES .-KING AMPOULE
INDUSTRIES (U) LIMITED ABDULLAH II, INDUSTRIAL
JORDAN
899 NDA/MAL/H AMMAN WIDE APIMOL TIMOLOL 0.5%W/V AMMAN JORDAN OPHTHALMI 1.0X1.0X5 7/1/2005
DP/1754 PHARMACEUT SPECTRUM MALEATE PHARMACEUTICALS C DROPS .0 ML
ICAL ENTERPRISES INDUSTRIES .-KING VIAL
JORDAN
900 NDA/MAL/H MEMPHIS WIDE DOPAGON BROMOCRIPT 2.5MG MEMPHIS COMPANY--8 EL EGYPT ORAL SOLID 1.0X2.0X1 7/1/1999
DP/1755 COMPANY SPECTRUM TABLETS INE SAWAH STREET, CAIRO. ORDINARY 0.0
ENTERPRISES EGYPT TABLETS TABLET
(U) LIMITED BLISTER
901 NDA/MAL/H AMMAN WIDE APICROM SODIUM 2%W/V AMMAN JORDAN OPHTHALMI 1.0X1.0X1 7/1/2005
DP/1756 PHARMACEUT SPECTRUM 2% CROMOGLYC PHARMACEUTICALS C DROPS 0.0 ML
ICAL ENTERPRISES ATE INDUSTRIES .-KING VIAL
JORDAN
902 NDA/MAL/H AMMAN WIDE APICORT PREDNISOLO 0.12%W/V AMMAN JORDAN OPHTHALMI 1.0X1.0X1 7/1/2005
DP/1758 PHARMACEUT SPECTRUM NE ACETATE PHARMACEUTICALS C DROPS 0.0 ML
JORDAN
903 NDA/MAL/H SHAIGAN HEALTHCARE AMLOPIN AMLODIPINE 5MG SHAIGAN PAKISTAN ORAL SOLID 1.0X2.0X1 7/1/2004
DP/1759 PHARMACEUT LTD. PHARMACEUTICALS (PVT) ORDINARY 0.0
ICALS LTD LTD-14TH KM, ADYALA TABLETS TABLET
PAKISTAN
904 NDA/MAL/H AMMAN WIDE NEODEX NEOMYCIN 0.5%W/V + AMMAN JORDAN OTIC DROPS 1.0X1.0X1 7/1/2005
DP/1760 PHARMACEUT SPECTRUM +DEXAMETHA 0.1%W/V PHARMACEUTICALS 0.0 ML
ICAL ENTERPRISES SONE INDUSTRIES-AMMAN VIAL
INDUSTRIES-KING
JORDAN
905 NDA/MAL/H EMCURE HARLEYS ATAZOR-R ATAZANAVIR 300 MG + EMCURE INDIA ORAL SOLID 1.0X30.0 7/1/2014
DP/1761 PHARMACEUT UGANDA + RITONAVIR 100 MG PHARMACEUTICALS LTD .- ORDINARY TABLET
ICALS LTD LIMITED PLOT NO. P-2 IT-BT PARK FILM- BOTTLE
PHASE II MIDC HINJWADI COATED
PUNE 411057 TABLETS
906 NDA/MAL/H AMMAN WIDE APITROPIN ATROPINE 1%W/V AMMAN JORDAN OPHTHALMI 1.0X1.0X1 7/1/2005
DP/1762 PHARMACEUT SPECTRUM PHARMACEUTICALS C DROPS 0.0 ML
JORDAN
907 NDA/MAL/H LABORATORY HARLEYS ASPIRIN ACETYL 300MG LABORATORY & ALLIED KENYA ORAL SOLID 1.0X20.0X 7/1/1997
DP/1763 &ALLIED LTD UGANDA TABLETS BP SALICYLIC LTD.-PLOT 209/10349 OFF ORDINARY 10.0
LIMITED ACID MOMBASA RD NAIROBI TABLETS TABLET
BLISTER,1.
0X500.0
TABLET
CONTAIN
ER,1.0X10
00.0
TABLET
CONTAIN
ER
908 NDA/MAL/H JOHNSON PHILLIPS FRESH ALCOHOL + 95 % W/V JOHNSON&JOHNSON PTY SOUTH ORAL LIQUID 1.0X250.0 7/1/2006
DP/1764 &JOHNSON PHARMACEUTIC BURST THYMOL + 12 MG LTD..-241 MAIN ROAD AFRICA ORDINARY ML
(PTY) LTD ALS (UGANDA) LISTERINE RETREAT 794 LIQUIDS CONTAIN
LIMITED ER,1.0X50
0.0 ML
CONTAIN
ER
909 NDA/MAL/H UMEDICA VITACARE RILIF PLUS ACECLOFENA 100MG + UMEDICA LABORATORIES INDIA ORAL SOLID 1.0X3.0X1 7/1/2012
DP/1765 LABORATORIE LIMITED C+ 500MG PVT LTD-PLOT NO. 221, ORDINARY 0.0
S PVT LTD PARACETAM 2ND PHASE, GIDC, VAPI TABLETS TABLET
OL 396195, GUJARAT. INDIA. BLISTER
910 NDA/MAL/H RENE RENE COLDEASE PARACETAM 400MG+30 RENE INDUSTRIES LIMITED- UGANDA ORAL SOLID 1.0X10.0X 7/1/2005
DP/1766 INDUSTRIES INDUSTRIES CAPSULES OL+CAFFEINE MG+4MG+ PLOT 680, KAMULI ROAD, ORDINARY 10.0
LTD LIMITED CITRATE+CHL 30MG KIREKA CAPSULES CAPSULE
ORPHENIRAM BLISTER
INE
MALEATE+PS
EUDOEPHEDR
INE
HYDROCHLOR
IDE
911 NDA/MAL/H EVA PHARMA WIDE PROSTEROL ALFUZOSIN 10MG EVA PHARMA FOR EGYPT ORAL SOLID 1.0X2.0X1 7/1/2013
DP/1767 FOR SPECTRUM HYDROCHLOR PHARMACEUTICALS AND ORDINARY 0.0
PHARMACEUT ENTERPRISES IDE MEDICAL APPLIANCES-176 TABLETS TABLET
ICALS & (U) LIMITED EL SADAT ST. KAFR EL BLISTER,1.
MEDICAL GABAL, PYRAMIDS, GIZA, 0X3.0X10.
APPLIANCES - EGYPT 0 TABLET
BLISTER
912 NDA/MAL/H BETA BETA ULTIVA REMIFENTANI 2MG GLAXOSMITHKLINE ITALY PARENTERAL 1.0X1.0 7/1/1999
DP/1768 HEALTHCARE HEALTHCARE INJECTION L MANUFACTURING SPA ,.,- ORDINARY VIAL
UGANDA UGANDA 2MG STRADA PROVINCIALE DRY VIALS CARTON
LIMITED LIMITED ASOLANA, 90-43056,
S.POLO DI TORRILE
(PARMA)
913 NDA/MAL/H GLAXOSMITH UNITED ENGERIX-B HEPATITIS B 10MCG/ML GLAXOSMITHKLINE BELGIUM PARENTERAL 1.0X10.0X 7/1/1997
DP/1769 KLINE HEALTHCARE VACCINE SURFACE BOILOGICALS-S.A RUE DE ORDINARY 0.5 ML
PHARMACEUT DISTRIBUTORS ANTIGEN I'INSTITUT 89 B-1330 VIALS VIAL (1
ICAL KENYA LTD RIXENSART DOSE),1.0
LTD X25.0X0.5
ML VIAL
(1 DOSE)
914 NDA/MAL/H MISSION JOINT MEDICAL ORAL MULTI- MULTI- MEDICAMEN BIOTECH LTD- INDIA ORAL LIQUID 1.0X100.0 7/1/2010
DP/1771 PHARMA A/S STORE (UPMB - REHYDRATI INGREDIENT INGREDIEN SP-1192, A &B, PHASE –IV, ORDINARY X20.5 G
UCMB) ON SALTS T INDUSTRIAL AREA UNIT DOSE SACHET
BP BHIWADI -301019 DIST. POWDERS
ALWAR (RAJASTHAN)
915 NDA/MAL/H SUN STAR GESTID COMPOUND 385MG SUN PHARMACEUTICAL INDIA ORAL SOLID 1.0X5.0X4 7/1/2000
DP/1772 PHARMACEUT PHARMACEUTIC TABLETS MAGNESIUM INDUSTRIES LIMITED,- ORDINARY .0 TABLET
ICAL ALS LTD TRISILICATE INDUSTRIAL AREA NO.3, TABLETS BLISTER
INDUSTRIES A.B.ROAD DEWAS,455001
LIMITED MADHYA PRADESH INDIA.
916 NDA/MAL/H MICRO LABS LABOREX LEVOBACT LEVOFLOXACI 500MG MICRO LABS LTD--NO 92, INDIA ORAL SOLID 1.0X20.0X 7/1/2005
DP/1773 LTD UGANDA 500 N SIPCOT, HOSUR-635 126,, ORDINARY 5.0
LIMITED HEMIHYDRAT TAMIL NADU, INDIA FILM- TABLET
E COATED BLISTER,1.
TABLETS 0X1.0X10.
0 TABLET
BLISTER
917 NDA/MAL/H CIPLA LTD. QUALITY NUZAC 20 FLUOXETINE 20MG CIPLA LTD ..-PLOT NO. 910 INDIA ORAL SOLID 1.0X10.0X 7/1/2003
DP/1777 CHEMICALS LTD - & 15 INDORE SPECIAL ORDINARY 10.0
HUMAN ECONOMIC ZONE PHASE II CAPSULES CAPSULE
PITHAMPUR DISTRICT BLISTER
DHAR MADHYA PRADESH
454775 CIPLA LTD -PLOT
NO. L-139, VERNA, GOA
403 722 INDIA
918 NDA/MAL/H PHARCO WIDE FARCONCIL AMOXYCILLIN 500MG PHARCO EGYPT ORAL SOLID 1.0X2.0X1 7/1/1998
DP/1778 PHARMACEUT SPECTRUM 500MG TRIHYDRATE PHARMACEUTICALS LTD- ORDINARY 0.0
ICALS ENTERPRISES CAPSULES KILO 31 ALEXANDRIA, CAPSULES CAPSULE
(U) LIMITED CAIRO DESERT ROAD, BLISTER
ALEXANDRIA EGYPT
919 NDA/MAL/H BROOKES HARLEYS PYODINE POVIDONE 10.0G/100 BROOKES PAKISTAN TOPICAL 1.0X60.0 7/1/2006
DP/1779 PHARMACEUT UGANDA SOLUTION IODINE ML PHARMACEUTICALS EXTERNAL ML
ICAL LIMITED LABORATORIES LIQUIDS BOTTLE,1.
LABORATORIE (PAKISTAN) LTD-PLOT 58 0X450.0
SL SECTOR 15 KORANGI ML
INDUSTRIAL AREA, BOTTLE,1.
KARACHI-PAKISTAN 0X500.0
ML
BOTTLE
920 NDA/MAL/H RENE RENE RENETRIM CO- 240MG/5 RENE INDUSTRIES LIMITED- UGANDA ORAL LIQUID 1.0X60.0 7/1/2000
DP/1780 INDUSTRIES INDUSTRIES SUSPENSIO TRIMOXAZOL ML PLOT 680 KAMULI KIREKA ORDINARY ML
LTD LIMITED N E SUSPENSION BOTTLE
S
921 NDA/MAL/H ASTRAZENEC MACNAUGHTON ARIMIDEX ANASTROZOL 1MG ASTRAZENECA UNITED ORAL SOLID 1.0X2.0X1 7/1/2000
DP/1781 A LIMITED E PHARMACEUTICALS LP- STATES ORDINARY 4.0
NEWARK, DELAWARE FILM- TABLET
COATED BLISTER
TABLETS
922 NDA/MAL/H GITTOES GITTOES CO- ARTEMETHER PER 5ML: AGOG PHARMA LTD-PLOT INDIA ORAL LIQUID 1.0X60.0 7/1/2010
DP/1782 PHARMACEUT PHARMACEUTIC METHER + 15MG + NO.33,SECTOR ORDINARY ML
ICALS LIMITED ALS LIMITED LUMEFANTRI 90MG II,VASAI,TALUKA INDL CO- SUSPENSION BOTTLE,1.
NE OP ESTATE LTD,GAURAI S 0X30.0 ML
E INDIA
923 NDA/MAL/H LABORATORY HARLEYS LAEOVATE BETAMETHAS 0.1%W/W LABORATORY & ALLIED KENYA TOPICAL 1.0X1.0X1 7/1/1997
DP/1783 AND ALLIED UGANDA OINTMENT ONE LTD--PLOT NO. 209/ EXTERNAL 5.0 G
LTD LIMITED VALERATE 10349, OPP. SAMEER OINTMENTS TUBE
BUSINESS PARK,
MOMBASA ROAD P.O.
BOX 42875, GPO 00100,
NAIROBI, KENYA
924 NDA/MAL/H MACLEODS NORVIK AZICURE- AZITHROMYCI 500MG MACLEODS INDIA ORAL SOLID 1.0X3.0 7/1/2005
DP/1784 PHARMACEUT ENTERPRISES 500 N PHARMACEUTICALS ORDINARY TABLET
ICALS LTD LIMITED LIMITED (BLOCK –N1)- TABLETS BLISTER
VILLAGE THEDA, P.O.
LODHI MAJRA,TEHSIL
BADDI, HIMACHAL
PRADESH -174101,INDIA
925 NDA/MAL/H BETA BETA ACTION ACETYL 600MG+50 BETA HEALTHCARE KENYA ORAL SOLID 1.0X200.0 7/1/1997
DP/1785 HEALTHCARE HEALTHCARE TABLETS SALICYLATE + MG+300M INTERNATIONAL LTD - - ORDINARY TABLET
UGANDA UGANDA CAFFEINE + G PLOT TABLETS CONTAIN
LIMITED LIMITED PARACETAM NO.209/6554,MOGADISHU ER,1.0X10
OL ROAD,OFF LUNGA LUNGA 0.0
INDUSTRIAL AREA, TABLET
P.O.BOX 42569-001000 CONTAIN
NAIROBI,KENYA ER,1.0X11
0.0
TABLET
STRIP,1.0X
12.0
926 NDA/MAL/H GITTOES GITTOES AGONAC DICLOFENAC 50MG AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1.0X1000. 7/1/2001
DP/1786 PHARMACEUT PHARMACEUTIC TABLETS NO. 33, SECTOR II, VASAI, ORDINARY 0 TABLET
ICALS LIMITED ALS LIMITED (THANE) TALUKA INDL. ENTERIC- CONTAIN
COATED ER,10.0X1
TABLETS 0.0
TABLET
BLISTER
927 NDA/MAL/H REGAL REGAL PHARMA UNITRIM CO- 480MG REGAL KENYA ORAL SOLID 10.0X10.0 7/1/1997
DP/1790 PHARMACEUI (U) LTD TABLET TRIMOXAZOL PHARMACEUTICALS LTD- ORDINARY TABLET
CALS LTD E BABA DOGO ROAD, TABLETS BLISTER,1.
RAURAKA,NAIROBI,KENYA 0X250.0
TABLET
CONTAIN
ER,1.0X10
00.0
TABLET
CONTAIN
ER
928 NDA/MAL/H DAR AL DAWA GAMA LIPODAR ATORVASTATI 20MG DAR AL DAWA-NA'UR JORDAN ORAL SOLID 1.0X3.0X1 7/1/2013
DP/1792 DEVELOPMEN PHARMACEUTIC N PLANT AMMAN ORDINARY 0.0
T AND ALS (U) LIMITED TABLETS TABLET
INVESTMENT BLISTER
CO LTD
929 NDA/MAL/H MACNAUNGH MACNAUGHTON SYMBICORT BUDESONIDE 80MCG+4. ASTRAZENECA AB,- SWEDEN LUNG 1.0X60.0 7/1/2001
DP/1793 TON LIMITED LIMITED TURBUHAL +FORMOTER 5MCG/DOS GARTUNA & SNACKVIKEN ADMINISTRA DOSE
ER OL E STOCKHOLM TION CFC- CANNISTE
FREE R
METERED-
DOSE
INHALER
930 NDA/MAL/H KOPRAN TATA UGANDA AMPIK-250 AMPICILLIN 250MG KOPRAN LIMITED-VILLAGE- INDIA ORAL SOLID 10.0X10.0 7/1/1997
DP/1795 LIMITED LIMITED SAVROLI (KHOPOLI), ORDINARY CAPSULE
TALUKA- KHALAPUR, DIST. CAPSULES BLISTER,1.
INDIA CAPSULE
CONTAIN
ER
931 NDA/MAL/H AJANTA ABACUS ZAHA 250 AZITHROMYCI 250 MG AJANTA PHARMA LIMITED INDIA ORAL SOLID 1.0X2.0X1 7/1/2006
DP/1796 PHARMA LTD PHARMA N PAITHAN- ORDINARY 0.0
(AFRICA) MANUFACTURING UNIT B- TABLETS TABLET
LIMITED 4/5/6 MIDC PAITHAN BLISTER,1.
DISTRICT AURANGABAD 0X10.0X1.
431 148 MAHARASTRA 0X6.0
STATE INDIA TABLET
BLISTER
932 NDA/MAL/H KARNATAKA TATA UGANDA AMPICILLIN AMPICILLIN + 250 MG + KARNATAKA ANTIBIOTICS INDIA PARENTERAL 1.0X10.0X 7/1/2010
DP/1797 ANTIBIOTICS LIMITED +CLOXACILL CLOXACILLIN 250 MG & PHARMACEUTICALS LTD- ORDINARY 500.0 MG
& IN #14, II PHASE PIA, DRY VIALS VIAL
PHARMACEUT BANGALORE 560058
ICALS LTD
933 NDA/MAL/H INTAS NORVIK CARDITAS NIFEDIPINE 20MG INTAS PHARMACEUTICALS INDIA ORAL SOLID 10.0X10.0 7/1/1997
DP/1798 PHARMACEUT ENTERPRISES RETARD LTD, VATVA-7/3 G.I.D.C. RETARD TABLET
ICALS LIMITED LIMITED ESTATE, PHASE-1, B/H FILM- BLISTER
DENA BANK VATVA, COATED
AHMEDABAD-382 445 TABLETS
GUJARAT, INDIA
INTAS
PHARMACEUTICALS
LIMITED(BIOPHARMA
DIVISION)-CAMP ROAD
SELAQUI-248197,
DEHRADUN
934 NDA/MAL/H INTAS NORVIK SECZOL DS SECNIDAZOLE 1GM INTAS PHARMACEUTICALS INDIA ORAL SOLID 1.0X2.0 7/1/2001
DP/1799 PHARMACEUT ENTERPRISES LTD-PLOT 457/458, ORDINARY TABLET
ICALS LTD LIMITED SARKHEJ BAVLA HIGHWAY TABLETS BLISTER
MATODA 382 210 TAL:
SANAND, AHMEDABAD,
INDIA
935 NDA/MAL/H MICRO LABS PHILLIPS AMLONG- AMLODIPINE 5MG MICRO LABS LTD-92, INDIA ORAL SOLID 1.0X10.0X 7/1/2009
DP/1800 LIMITED PHARMACEUTIC 10 SIPCOT INDUSTRIAL ORDINARY 10.0
LIMITED (T.N) INDIA BLISTER,1.
0X3.0X10.
0 TABLET
BLISTER
936 NDA/MAL/H LABORATORY HARLEYS LABESTEN CLOTRIMAZO 100MG LABORATORY & ALLIED KENYA VAGINAL 1.0X1.0X6 7/1/1997
DP/1801 &ALLIED LTD UGANDA PESSARIES LE LTD.---PLOT 209/10349 TABLETS .0
LIMITED OFF MOMBASA RD PESSARY
NAIROBI STRIP
937 NDA/MAL/H ASTRA MACNAUGHTON NEXIUM ESOMEPRAZO 40MG ASTRAZENECA AB.- SWEDEN ORAL SOLID 1.0X7.0 7/1/2001
DP/1803 ZENECA AB LIMITED 40MG LE GARTUNA & SNACKVIKEN ORDINARY TABLET
STOCKHOLM FILM- BLISTER,1.
COATED 0X14.0
TABLETS TABLET
CARTON,1
.0X28.0
TABLET
CARTON
938 NDA/MAL/H TORRENT KARURI LISTRIL LISINOPRIL 5MG TORRENT INDIA ORAL SOLID 1.0X10.0X 7/1/2001
DP/1804 PHARMACEUT PHARMACEUTIC PHARMACEUTICAL LTD- ORDINARY 10.0
ICALS LTD ALS LTD. AHMEDABAD-MEHSANA TABLETS TABLET
HIGHWAY,TALUKA- BLISTER
KADI,DIST.MEHSANA,INDR
AD-382721
939 NDA/MAL/H MSD (PTY) PHILLIPS JANUMET SITAGLIPTIN + 50MG + AESICA QUEESNBOROUGH UNITED ORAL SOLID 1.0X4.0X1 7/1/2014
DP/1805 LIMITED SA PHARMACEUTIC METFORMIN 1000MG LTD .-NORTH ROAD, KINGDOM ORDINARY 4.0
ALS (UGANDA) HYDROCHLOR QUEENBOROUGH KENT FILM- TABLET
LIMITED IDE ME 11 5EL, UNITED COATED BLISTER
KINGDOM TABLETS
940 NDA/MAL/H BLUE CROSS STAR BLUMOX P AMOXYCILLIN 125MG BLUE CROSS INDIA ORAL SOLID 10.0X10.0 7/1/2000
DP/1806 LABORATORIE PHARMACEUTIC LABORATORIES LIMITED-A- ORDINARY X2.0
S LIMITED ALS LTD 12 MIDC AMBAD-NASHIK- TABLETS TABLET
422010 MAHARASHTRA STRIP
STATE, INDIA
941 NDA/MAL/H GLAXOSMITH UNITED AMPICLOX AMPICILLIN + 60 MG / MEDREICH STERILAB LTD- INDIA ORAL LIQUID 1.0X8.0 7/1/1997
DP/1807 KLINE HEALTHCARE NEONATAL CLOXACILLIN 0.6 ML + 12TH MILE, OLD MADRAS ORDINARY ML
PHARMACEUT DISTRIBUTORS DROPS 30 MG / ROAD, VIRGONAGOR, DRY BOTTLE
ICAL KENYA LTD 0.6 ML BANGALORE 560049, SUSPENSION
LTD INDIA S/SYRUPS/D
ROPS
942 NDA/MAL/H ASTRA ASTRA PHARMA ASTACID MAGNESIUM 370MG ASTRA LIFE CARE (INDIA) INDIA ORAL SOLID 1.0X1000. 7/1/1997
DP/1808 PHARMA (U) (U) LIMITED TRISILICATE PVT LIMITED-57/P RAJODA ORDINARY 0 TABLET
LIMITED 382220 BAVIA CHEWABLE CONTAIN
AHMEDABAD INDIA TABLETS ER,1.0X10
.0X10.0
TABLET
BLISTER
943 NDA/MAL/H GITTOES GITTOES AGOVIT-6 PYRIDOXINE 25MG AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1.0X1000. 7/1/2004
DP/1809 PHARMACEUT PHARMACEUTIC NO.33,SECTOR ORDINARY 0 TABLET
E INDIA TABLET
BLISTER
944 NDA/MAL/H GITTOES GITTOES AGOTRI TRIFLUOPERA 5MG AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1.0X10.0X 7/1/2010
DP/1810 PHARMACEUT PHARMACEUTIC ZINE NO.33,SECTOR ORDINARY 10.0
E INDIA TABLET
CONTAIN
ER
945 NDA/MAL/H CIPLA LTD QUALITY DUOVIR ZIDOVUDINE+ 300MG + CIPLA LTD---PLOT NO. 143 INDIA ORAL SOLID 1.0X6.0X1 7/1/2001
DP/1811 CHEMICALS LTD - TABLETS LAMIVUDINE 150MG AND L-144A VERNA IND. ORDINARY 0.0
HUMAN ESTATE SALCETTE GOA TABLETS TABLET
403 722 CIPLA QUALITY BLISTER,1.
CHEMICAL INDUSTRIES 0X60.0
LIMITED - -PLOT 1-7 1ST TABLET
RING ROAD, LUZIRA, BOTTLE
KAMPALA
946 NDA/MAL/H RENE RENE REQUIN QUININE 300MG RENE INDUSTRIES LIMITED- UGANDA ORAL SOLID 1.0X1000. 7/1/2001
DP/1812 INDUSTRIES INDUSTRIES TABLETS SULPHATE PLOT 680, KAMULI ROAD, ORDINARY 0 TABLET
LTD LIMITED KIREKA FILM- CONTAIN
COATED ER,1.0X10
TABLETS .0X10.0
TABLET
BLISTER
947 NDA/MAL/H DAWA SUPER MEDIC MOXAFORT AMOXICILLIN 125 MG + DAWA LTD-BABA DOGO KENYA ORAL LIQUID 1.0X100.0 7/1/2014
DP/1813 LIMITED LTD E + 125MG ROAD RUARAKA ORDINARY ML
FLUCLOXACIL DRY BOTTLE
LIN SUSPENSION
S/SYRUPS/D
ROPS
948 NDA/MAL/H GLENMARK STAR SUPIROCIN MUPIROCIN 2%W/W GLENMARK INDIA TOPICAL 1.0X15.0 7/1/2003
DP/1815 PHARMACEUT PHARMACEUTIC OINTMENT PHARMACEUTICALS LTD- EXTERNAL G TUBE
ICAL LTD ALS LTD PLOT NO E -37, 39 ,D OTHER
OINTMENTS
949 NDA/MAL/H MACK SHURIK LTD DRESS UP NEOMYCIN 0.5%W/W TORQUE INDIA TOPICAL 1.0X30.0 7/1/1998
DP/1816 BROWN CREAM SULPHATE PHARMACEUTICALS LTD - EXTERNAL G TUBE
PHARMECEUT ISSAPUR P.O DAPPAR CREAMS
950 NDA/MAL/H BLUE CROSS STAR MEFTAL MEFENAMIC 500MG BLUE CROSS INDIA ORAL SOLID 1.0X10.0X 7/1/1997
DP/1821 LABORATORIE PHARMACEUTIC 500 ACID LABORATORIES LTD-L-17, ORDINARY 10.0
S LTD ALS LTD TABLETS VERNA INDUSTRIAL TABLETS TABLET
ESTATE,VERNA GOA- STRIP
403722
951 NDA/MAL/H RENE RENE EPHEDRINE EPHEDRINE 30MG RENE INDUSTRIES LIMITED- UGANDA ORAL SOLID 1.0X1000. 7/1/2005
DP/1822 INDUSTRIES INDUSTRIES HYDROCHLOR PLOT 680, KAMULI ROAD, ORDINARY 0 TABLET
LTD LIMITED IDE KIREKA TABLETS CONTAIN
ER
952 NDA/MAL/H RENE RENE COLDEASE PARACETAM 120MG+2 RENE INDUSTRIES LIMITED- UGANDA ORAL LIQUID 1.0X100.0 7/1/2005
DP/1825 INDUSTRIES INDUSTRIES SYRUP OL+CHLORPH MG+15MG PLOT 680, KAMULI ROAD, ORDINARY ML
LIMITED LIMITED ENIRAMINE KIREKA SYRUPS BOTTLE
MALEATE+PS
EUDOEPHEDR
INE
HYDROCHLOR
IDE
953 NDA/MAL/H REGAL REGAL PHARMA ALBASOL ALBENDAZOL 200MG/5 REGAL KENYA ORAL LIQUID 1.0X10.0 7/1/2006
DP/1827 PHARMACEUT (U) LTD SUSPENSIO E ML PHARMACEUTICALS LTD- ORDINARY ML
ICALS LTD N BABA DOGO ROAD, SUSPENSION BOTTLE
RAURAKA,NAIROBI,KENYA S
954 NDA/MAL/H ASTRAZENEC MACNAUGHTON TENORET ATENOLOL + 50 MG + ASTRA ZENECA UK UNITED ORAL SOLID 1.0X2.0X1 7/1/1997
DP/1828 A LIMITED CHLORTHALID 12.5 MG LIMITED-SILK ROAD KINGDOM ORDINARY 4.0
ONE BUSINESS FILM- TABLET
PARK,MACCLESFIELD,CHES COATED BLISTER
HIRE SK 10 2NA, TABLETS
955 NDA/MAL/H ASTRA LIFE ASTRA PHARMA ASMOX AMOXICILLIN 500MG ASTRA LIFE CARE (INDIA) INDIA ORAL SOLID 1.0X10.0X 7/1/2011
DP/1833 CARE (INDIA) (U) LIMITED PVT-SURVEY NO.57/P, ORDINARY 10.0
PVT LTD SARKHEJ-BAVLA CAPSULES CAPSULE
HIGHWAY, POST- RAJOD- BLISTER
382220, TALUKA-BAVLA,
DIST-AHMEDABAD.
956 NDA/MAL/H INDOCO STAR ABZEE ALBENDAZOL 400MG INDOCO REMEDIES LTD-B- INDIA ORAL SOLID 1.0X1.0 7/1/2004
DP/1838 REMEDIES PHARMACEUTIC E 20, MIDC, WALUJ, ORDINARY TABLET
LIMITED ALS LTD AURANGABAB 431136 TABLETS BLISTER,1.
INDIA 0X500.0
TABLET
CONTAIN
ER
957 NDA/MAL/H REMEDICA GOODMAN OVA-MIT CLOMIPHENE 50MG REMEDICA LIMITED - CYPRUS ORAL SOLID 1.0X1.0X1 7/1/2011
DP/1840 LTD INTERNATIONAL AHARNON STREET, ORDINARY 0.0
LTD LIMASSOL INDUSTRIAL TABLETS TABLET
ESTATE. LIMASSOL, BLISTER
CYPRUS 3056, CYPRUS
958 NDA/MAL/H MACK SHURIK LTD FUNGNIL CLOTRIMAZO 1%W/W TORQUE INDIA TOPICAL 1.0X20.0 7/1/2000
DP/1841 BROWN CREAM LE PHARMACEUTICALS LTD- EXTERNAL G TUBE
959 NDA/MAL/H KAMPALA KAMPALA SUGAQUIN CHLOROQUIN 250MG KAMPALA UGANDA ORAL SOLID 1.0X1000. 7/1/2002
DP/1842 PHARMACEUT PHARMACEUTIC TABLETS E PHOSPHATE PHARMACEUTICALS ORDINARY 0 TABLET
ICAL AL INDUSTRIES INDUSTIES-PLOT NO M44B OTHER CONTAIN
INDUSTRIES 1996 LIMITED STRETCHER ROAD COATED ER,1.0X10
1996 LIMITED INTINDA TABLETS .0X10.0
TABLET
BLISTER
960 NDA/MAL/H USV PRIVATE ABACUS ECORIN-75 ASPIRIN 75MG REMEDEX PHARMA-B- INDIA ORAL SOLID 1.0X10.0X 7/1/2005
DP/1843 LIMITED PHARMA 249/250 PEENYA ORDINARY 10.0
(AFRICA) INDUSTRIAL ESTATE TABLETS TABLET
LIMITED BANGALORE 560 058 BLISTER
961 NDA/MAL/H GUILIN STAR SULFAMET SULFAMETHO 800MG GUILIN PHARMACEUTICAL CHINA ORAL SOLID 1.0X10.0X 7/1/2011
DP/1844 PHARMACEUT PHARMACEUTIC HOXAZOLE XAZOLE / /160MG CO.LTD.-NO.43 QUILIDIAN ORDINARY 10.0
ICALS CO.LTD ALS LTD / TRIMETHOPRI ROAD GUILIN 541002, TABLETS TABLET
TRIMETHO M GUANGXI, CHINA BLISTER,1.
PRIM 0X1000.0
TABLET
CONTAIN
ER
962 NDA/MAL/H LEBEN ANDYCO ANTAGIT ALUMINIUM 400MG + LEBEN LABORATORIES INDIA ORAL LIQUID 1.0X170.0 7/1/2013
DP/1846 LABORATORIE PHARMACY DS GEL HYDROXIDE + 400MG + PVT. LTD.-PLOT NO. L-4, ORDINARY ML
S PVT LTD (UGANDA) LTD ORANGE MAGNESIUM 50MG PHASE –III, M.I.D.C, SUSPENSION BOTTLE
FLAVOUR + AKOLA, 444104, S
SIMETHICONE MAHARASHTRA, INDIA.
963 NDA/MAL/H LEBEN ANDYCO MOXILEB- AMOXICILLIN 250MG LEBEN LABORATORIES INDIA ORAL SOLID 1.0X1000. 7/1/2007
DP/1847 LABORATORIE PHARMACY 250 PVT. LTD.-PLOT NO. L-4, ORDINARY 0
S PVT. LTD., (UGANDA) LTD CAPSULE PHASE –III, M.I.D.C, CAPSULES CAPSULE
INDIA AKOLA, 444104, CONTAIN
MAHARASHTRA, INDIA. ER,1.0X10
.0X10.0
CAPSULE
BLISTER,1.
0X100.0X1
0.0
CAPSULE
BLISTER
964 NDA/MAL/H LABORATORY HARLEYS PARATAL PARACETAM 500MG LABORATORY & ALLIED KENYA ORAL SOLID 1.0X1000. 7/1/1997
DP/1848 &ALLIED LTD UGANDA OL LTD--PLOT NO. 209/ ORDINARY 0 TABLET
LIMITED 10349, OPP. SAMEER TABLETS BLISTER,1.
BUSINESS PARK, 0X10.0X10
MOMBASA ROAD P.O. .0 TABLET
BOX 42875, GPO 00100, BLISTER
NAIROBI, KENYA
965 NDA/MAL/H ABACUS ABACUS CIFIN CIPROFLOXAC 0.2%W/V ABACUS PARENTERAL UGANDA PARENTERAL 1.0X100.0 7/1/2011
DP/1849 PARENTERAL PARENTERAL IN DRUGS LTD-PLOT NO. 114, ORDINARY ML
DRUGS DRUGS LIMITED BLOCK 191, GWAGAMYA, INFUSION BOTTLE
LIMITED KINGA, KAPEKE, VIALS/BOTTL
MUKONO ES
966 NDA/MAL/H RENE RENE ALZOL ALBENDAZOL 400MG RENE INDUSTRIES LTD- UGANDA ORAL SOLID 1.0X500.0 7/1/2010
DP/1850 INDUSTRIES INDUSTRIES TABLETS E PLOT 680, KAMULI ROAD, ORDINARY TABLET
LTD LIMITED KIREKA, P.O BOX 6034, TABLETS CONTAIN
KAMPALA ER
967 NDA/MAL/H PHILLIPS PHILLIPS CAPSIFENA CAPSAICIN + 0.438 G + STEDMAN INDIA TOPICAL 1.0X1.0X2 7/1/2011
DP/1851 PHARMACEUT PHARMACEUTIC C GEL DICLOFENAC 0.335 G + PHARMACEUTICALS PVT EXTERNAL 0.0 G
ICALS LIMITED ALS (UGANDA) + 0.135 G + LIMITED-NO. C-4, SIDCO EMULSION TUBE,1.0X
LIMITED LEVOMENTH 0.918 G PHARMACEUTICAL GELS 1.0X10.0
OL + METHYL COMPLEX, ALATHUR, G TUBE
SALICYLATE THIRUPORUR,
968 NDA/MAL/H ROYAL ROYAL PHARMA FUROSEMI FUROSEMIDE 10MG/ML REYOUNG CHINA PARENTERAL 1.0X10.0X 7/1/2004
DP/1854 PHARMA 2011 LIMITED DE PHARMACEUTICAL CO. ORDINARY 2.0 ML
2011 LIMITED INJECTION LIMITED-NO. 1 RUIYANG AMPOULES AMPOULE
ROAD YIYUAN COUNTY, ,1.0X100.0
SHANDONG PROVINCE, P. X2.0 ML
R. CHINA AMPOULE
969 NDA/MAL/H INTERMED ROYAL PHARMA QUININE QUININE 300MG AFRICURE INDIA ORAL SOLID 1.0X10.0X 7/1/2004
DP/1855 2011 LIMITED SULPHATE SULPHATE PHARMACEUTICALS ORDINARY 10.0
(INDIA) PRIVATE LIMITED TABLETS TABLET
(755793)-PLOT 9- BLISTER,1.
12,DEWAN & SONS 0X1000.0
INDUSTRIAL. AREA, TABLET
INDIA. ER
970 NDA/MAL/H COSMOS LTD ASTRA PHARMA PROPRANO PROPRANOLO 40MG COSMOS LIMITED-- KENYA ORAL SOLID 1.0X1000. 7/1/1998
DP/1856 (U) LIMITED LOL L RANGWA ROAD, OFF ORDINARY 0 TABLET
TABLETS HYDROCHLOR LUNGA LUNGA ROAD,P.O TABLETS CONTAIN
B.P. 40MG IDE BOX 414 33, NAIORBI ER,1.0X10
INDUSTRIAL AREA .0X10.0
TABLET
BLISTER
971 NDA/MAL/H GUILIN STAR SULFAMET SULFAMETHO 400MG GUILIN PHARMACEUTICAL CHINA ORAL SOLID 1.0X10.0X 7/1/2011
DP/1861 PHARMACEUT PHARMACEUTIC HOXAZOLE XAZOLE / /80MG CO.LTD.-NO.43 QUILIDIAN ORDINARY 10.0
ICALS CO LTD ALS LTD / TRIMETHOPRI ROAD GUILIN 541002, TABLETS TABLET
TRIMETHO M GUANGXI, CHINA BLISTER,1.
PRIM 0X1000.0
TABLET
CONTAIN
ER
972 NDA/MAL/H AMOUN WIDE ORACURE LIDOCAINE 2 GM+0.1 AMOUN EGYPT ORAL 1.0X15.0 7/1/2004
DP/1863 PHARMACEUT SPECTRUM GEL HCL+CETYL GM PHARMACEUTICALS CO. TOPICAL G TUBE
ICALS ENTERPRISES PYRIDINUM S.A.E-1ST INDUSTRIAL GELS AND
COMPANY (U) LIMITED CHLORIDE ZONE, EL-OBOUR CITY, SOLS
EGYPT.
973 NDA/MAL/H NORVATIS LABOREX PATANOL OLOPATADIN 0.1%W/V ALCON COUVREUR NV- BELGIUM OPHTHALMI 1.0X5.0 7/1/2009
DP/1864 PHARMA AG- UGANDA E RIJKSWEG 14, B-2870 C DROPS ML VIAL
SWITZERLAN LIMITED HYDROCHLOR PUURS BELGIUM
D IDE
974 NDA/MAL/H FDC LTD AIVEEN (U) MYCODER CLOTRIMAZO 1%W/W FDC LIMITED -B-8, INDIA TOPICAL 1.0X75.0 7/1/2014
DP/1865 LIMITED M-C LE M.I.D.C., INDUSTRIAL EXTERNAL G
POWDER AREA, WALUJ – POWDERS CONTAIN
AURANGABAD- 431 136 ER
MAHARASHTRA, INDIA.
975 NDA/MAL/H JASSEN-CILAG LABOREX NIZORAL KETOCONAZO 20MG/G SPECPHARM HOLDINGS- SOUTH TOPICAL 1.0X15.0 7/1/1997
DP/1866 (PTY) LTD UGANDA LE 15TH ROAD HALFWAY AFRICA EXTERNAL G TUBE
LIMITED HOUSE CREAMS
976 NDA/MAL/H MSD (PTY) PHILLIPS JANUMET SITAGLIPTIN + 50MG + AESICA QUEESNBOROUGH UNITED ORAL SOLID 1.0X4.0X1 7/1/2014
DP/1873 LIMITED SA PHARMACEUTIC METFORMIN 850MG LTD .-NORTH ROAD, KINGDOM ORDINARY 4.0
ALS (UGANDA) HYDROCHLOR QUEENBOROUGH KENT TABLETS TABLET
LIMITED IDE ME 11 5EL, UNITED BLISTER
KINGDOM
977 NDA/MAL/H RENE RENE MINT-O- DRIED 120MG + RENE INDUSTRIES LTD- UGANDA ORAL SOLID 1.0X500.0 7/1/2007
DP/1877 INDUSTRIES INDUSTRIES COOL ALUMINIUM 250MG PLOT 680, KAMULI ROAD, ORDINARY TABLET
LTD LIMITED HYDROXIDE + KIREKA, P.O BOX 6034, TABLETS CONTAIN
MAGNESIUM KAMPALA ER,1.0X10
TRISILICATE 00.0
TABLET
CONTAIN
ER
978 NDA/MAL/H SPARSH BIO- ABACUS SPENIV 250MG SPARSH BIO-TECH LTD- INDIA ORAL SOLID 1.0X1000. 7/1/2004
DP/1879 TECH PVT LTD PHARMA PHENOXYME PLOT NO.1 SURVEY ORDINARY 0 TABLET
(AFRICA) THYL NO.242/234/244, VILLAGE TABLETS CONTAIN
LIMITED PENICILLIN LAKHABARAD, JAMNAGAR- ER,1.0X10
361006 .0X10.0
TABLET
BLISTER
979 NDA/MAL/H SPARSH BIO- ABACUS SPAMCLOX AMPICILLIN + 250 MG + SPARSH BIO-TECH LTD- INDIA ORAL SOLID 1.0X10.0X 7/1/2004
DP/1880 TECH PVT. PHARMA CLOXACILLIN 250 MG PLOT NO.1 SURVEY ORDINARY 10.0
LTD (AFRICA) NO.242/234/244, VILLAGE CAPSULES CAPSULE
LIMITED LAKHABARAD, JAMNAGAR- BLISTER,1.
361006 0X1000.0
CAPSULE
CONTAIN
ER,1.0X10
0.0X10.0
CAPSULE
BLISTER
980 NDA/MAL/H SPARSH BIO- ABACUS SPAMOX AMOXYCILLIN 250MG SPARSH BIO-TECH PVT. INDIA ORAL SOLID 1.0X100.0 7/1/2004
DP/1881 TECH PVT. PHARMA LIMITED-PLOT NO. ORDINARY X10.0
LTD (AFRICA) 1;SURVEY NO. CAPSULES CAPSULE
LIMITED 242/243/244,LAKHABAVA BLISTER,1.
D,JAMNAGAR-361 006, 0X1.0X100
INDIA. 0.0
CAPSULE
CONTAIN
ER,1.0X10
.0X10.0
CAPSULE
BLISTER
981 NDA/MAL/H SPARSH BIO- ABACUS SPAMCIL AMPICILLIN 250MG SPARSH BIO-TECH LTD- INDIA ORAL SOLID 1.0X100.0 7/1/2004
DP/1882 TECH PVT LTD PHARMA PLOT NO.1 SURVEY ORDINARY X10.0
(AFRICA) NO.242/234/244, VILLAGE CAPSULES CAPSULE
361006 0X1000.0
CAPSULE
CONTAIN
ER,1.0X10
.0X10.0
CAPSULE
BLISTER
982 NDA/MAL/H KAMPALA KAMPALA KAMADOL PARACETAM 500MG KAMPALA UGANDA ORAL SOLID 1.0X100.0 7/1/1997
DP/1887 PHARMACEUT PHARMACEUTIC OL PHARMACEUTICAL ORDINARY X10.0
ICAL AL INDUSTRIES INDUSTRIES (1996) TABLETS TABLET
INDUSTRIES 1996 LIMITED LIMITED - -STRETCHER BLISTER,1
(1996) LTD ROAD PLOT M444B 00.0
NTINDA KAMPALA TABLET
CONTAIN
ER,250.0
TABLET
CONTAIN
ER,500.0
TABLET
983 NDA/MAL/H KAMPALA KAMPALA KAM PREDNISOLO 5MG KAMPALA UGANDA ORAL SOLID 1.0X1000. 7/1/1997
DP/1889 PHARMACEUT PHARMACEUTIC PREDSOL NE PHARMACEUTICAL ORDINARY 0 TABLET
ICAL AL INDUSTRIES INDUSTRIES (1996) TABLETS CONTAIN
INDUSTRIES 1996 LIMITED LIMITED - -STRETCHER ER,1.0X50
LTD ROAD PLOT M444B 0.0
CONTAIN
ER,1.0X25
0.0
TABLET
CONTAIN
ER,1.0X10
984 NDA/MAL/H MACLEODS NORVIK LEVOMAC LEVOFLOXACI 500MG MACLEODS INDIA ORAL SOLID 1.0X20.0X 7/1/2005
DP/1891 PHARMACEUT ENTERPRISES 500 N PHARMACEUTICALS LTD - ORDINARY 5.0
ICAL LTD LIMITED PLOT NO. 25-27, SURVEY FILM- TABLET
NO. 366, PREMIER COATED BLISTER
INDUSTRIAL ESTATE, TABLETS
KACHIGAM DAMAN
(UT), INDIA.
985 NDA/MAL/H KOPRAN TATA UGANDA TRIM-480 CO- 480MG KOPRAN LIMITED-VILLAGE- INDIA ORAL SOLID 10.0X10.0 7/1/1997
DP/1894 LIMITED LIMITED TRIMOXAZOL SAVROLI (KHOPOLI), ORDINARY TABLET
E TALUKA- KHALAPUR, DIST. TABLETS BLISTER,1.
INDIA TABLET
CONTAIN
ER
986 NDA/MAL/H GITTOES GITTOES TRIMAGO CO- 100MG/20 AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1.0X10.0X 7/1/2007
DP/1895 PHARMACEUT PHARMACEUTIC (PAEDIATRI TRIMOXAZOL MG NO.33,SECTOR ORDINARY 10.0
ICALS LIMITED ALS LIMITED C) E II,VASAI,TALUKA INDL CO- TABLETS TABLET
E INDIA TABLET
CONTAIN
ER,1.0X10
0.0X10.0
TABLET
BLISTER
987 NDA/MAL/H WIN- SURGIPHARM ZAPACID - LANSOPRAZO 30MG WIN MEDICARE PVT INDIA ORAL SOLID 3.0X10.0 7/1/2001
DP/1898 MEDICARE (U) LIMITED 30 LE LIMITED-MEERUT, ORDINARY CAPSULE
LTD MUZAFFARNAGER ROAD, CAPSULES BLISTER
MODIPURAM – 250110,
UTTAR
PRADESH - INDIA
988 NDA/MAL/H GITTOES GITTOES AGOM 20 OMEPRAZOLE 20MG AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1.0X2.0X1 7/1/2007
E INDIA .0
CAPSULE
STRIP
989 NDA/MAL/H AJANTA ABACUS IBUMOL IBUPROFEN + 100MG + AJANTA PHARMA LIMITED- INDIA ORAL LIQUID 1.0X100.0 7/1/2013
DP/1901 PHARMA LTD PHARMA PARACETAM 162.5 MG 31-0 MIDC INDUSTRIAL ORDINARY ML
31-0 (AFRICA) OL /5ML AREA CHIKALTHANA SUSPENSION BOTTLE
AURANGABAD
MAHARASHTRA STATE
990 NDA/MAL/H KAMPALA KAMPALA KAMODIU LOPERAMIDE 2MG KAMPALA UGANDA ORAL SOLID 1.0X10.0X 7/1/1997
DP/1902 PHARMACEUT PHARMACEUTIC M HYDROCHLOR PHARMECEUTICALS ORDINARY 10.0
ICAL AL INDUSTRIES IDE INDUSTRIES LTD.-PLOT CAPSULES CAPSULE
991 NDA/MAL/H ACG CIPLA QUALITY EFAVIRENZ EFAVIRENZ 600MG CIPLA QUALITY CHEMICAL UGANDA ORAL SOLID 1.0X30.0 7/1/2013
DP/1906 PHARMAPACK CHEMICAL TABLETS INDUSTRIES LIMITED-PLOT ORDINARY TABLET
PVT. LTD INDUSTRIES 600MG 1-7, LUZIRA FILM- CONTAIN
LIMITED COATED ER
TABLETS
992 NDA/MAL/H CIPLA LTD QUALITY ABACAVIR ABACAVIR 300MG CIPLA LTD-UNIT I & II A-32 INDIA ORAL SOLID 1.0X60.0 7/1/2004
DP/1907 CHEMICALS LTD - & A-42 MIDC ORDINARY TABLET
HUMAN PATALGANGA 410220, TABLETS BOTTLE
DIST- RAIGAD,
MAHARASHTRA, INDIA
993 NDA/MAL/H COSMOS LTD ASTRA PHARMA CODEINE CODEINE 30MG COSMOS LIMITED - KENYA ORAL SOLID 1.0X100.0 7/1/1998
DP/1911 (U) LIMITED PHOSPHAT PHOSPHATE RANGWA ROAD, OFF ORDINARY TABLET
E TABLETS LUNGA LUNGA ROAD, TABLETS CONTAIN
BP 30 INDUSTRIAL AREA ER,1.0X10
00.0
TABLET
CONTAIN
ER,1.0X10
.0X10.0
TABLET
BLISTER
994 NDA/MAL/H MACK SHURIK LTD D-WORM ALBENDAZOL 200MG TORQUE INDIA ORAL SOLID 1.0X2.0 7/1/2008
DP/1912 BROWN E PHARMACEUTICALS LTD- ORDINARY TABLET
PHARMECEUT ISSAPUR P.O DAPPAR TABLETS BLISTER
995 NDA/MAL/H RENE RENE CHLORPHE CHLORPHENI 4MG RENE INDUSTRIES LTD- UGANDA ORAL SOLID 1.0X1000. 7/1/2003
DP/1914 INDUSTRIES INDUSTRIES NIRAMINE RAMINE PLOT 680, KAMULI ROAD, ORDINARY 0 TABLET
KAMPALA ER
996 NDA/MAL/H HETERO LABS AIVEEN (U) ATAZANAVI ATAZANAVIR 300 MG + HETERO LABS LTD UNIT III- INDIA ORAL SOLID 1.0X30.0 7/1/2013
DP/1915 LTD LIMITED R SULPHATE + 100 MG 22-110 IDA JEEDIMETIA ORDINARY TABLET
SULPHATE RITONAVIR HYDERABAD ANDHRA TABLETS CONTAIN
+ PRADESH , HETERO LABS ER
RITONAVIR LTD (UNIT-V)-
SY.NO.438,439,440 & 458
APIIC FORMULATION SEZ,
POLEPALLY (V),
JEDCHERLA (M)
MAHABOOBNAGAR
DISTRICT, ANDHRA
PRADESH - INDIA
997 NDA/MAL/H UNIVERSAL HARLEYS UNIVIR ACYCLOVIR 200MG UNIVERSAL CORPORATION KENYA ORAL SOLID 1.0X1.0X3 7/1/2010
DP/1918 CORPORATIO UGANDA LTD-KIKUYU NAIROBI ORDINARY 0.0
N LTD LIMITED KENYA TABLETS TABLET
STRIP
998 NDA/MAL/H GLENMARK STAR CANDIDER BECLOMETAS 0.025%W/ GLENMARK INDIA TOPICAL 1.0X5.0 G 7/1/1999
DP/1919 PHARMACEUT PHARMACEUTIC M CREAM ONE/CLOTRI W+1%W/ PHARMACEUTICALS LTD- EXTERNAL TUBE,1.0X
ICAL LTD ALS LTD MAZOLE/GEN W+0.1%W/ PLOT NO E -37, 39 ,D CREAMS 15.0 G
TAMYCIN W TUBE
999 NDA/MAL/H SHAIGAN HEALTHCARE ANTIMIN LORATIDINE 10MG SHAIGAN PAKISTAN ORAL SOLID 1.0X1.0X1 7/1/2005
DP/1921 PHARMACEUT LTD. PHARMACEUTICALS (PVT) ORDINARY 0.0
PAKISTAN
1000 NDA/MAL/H IPCA MEDVIN AZIFAST- AZITHROMYCI 500MG IPCA LABORATORIES INDIA ORAL SOLID 1.0X10.0X 7/1/2007
DP/1922 LABORATORIE PHARMA 500 N LTD,PLOT NO. T-139 - ORDINARY 3.0
S LIMITED LIMITED SEJAVTA, RATLAM-457 002 FILM- TABLET
(M.P.) INDIA COATED BLISTER
TABLETS
1001 NDA/MAL/H GALENTIC VITACARE BETAMETH BETAMETHAS 0.1%W/W GALENTIC PHARMA( INDIA INDIA TOPICAL 1.0X15.0 7/1/2005
DP/1923 PHARMA LIMITED ASONE ONE ) PVT LTD-R-673,MIDC TTC EXTERNAL G TUBE
(PVT)LTD RABALE THANE-BELAPUR CREAMS
ROAD,NAVI
1002 NDA/MAL/H ASTRA ASTRA PHARMA AMPICILLIN AMPICILLIN 500MG CSPC ZHONGNUO CHINA PARENTERAL 1.0X50.0X 7/1/2013
DP/1924 PHARMA (U) (U) LIMITED SODIUM SODIUM PHARMACEUTICAL ORDINARY 500.0 MG
LIMITED (SHIJIAZHUANG)CO. LTD- DRY VIALS VIAL
NO. 88, YANGZI ROAD,
SHIJIAZHUANG CITY,
HEBEI
PROVINCE(WORKSHOP
406 AND 407)
1003 NDA/MAL/H REGAL REGAL PHARMA INTAPLEX VITAMIN B N/A REGAL KENYA ORAL SOLID 1.0X100.0 7/1/1997
DP/1927 PHARMACEUT (U) LTD TABLET COMPOUND PHARMACEUTICALS LTD- ORDINARY X10.0
ICALS LTD BABA DOGO ROAD, TABLETS TABLET
RAURAKA,NAIROBI,KENYA BLISTER,1.
0X1000.0
TABLET
CONTAIN
ER,1.0X10
.0X10.0
TABLET
BLISTER
1004 NDA/MAL/H STEDMAN VEERAM NEUTRAFLU ALGINIC ACID 200MG + STEDMAN INDIA ORAL SOLID 1.0X10.0X 7/1/2013
DP/1928 PHARMACEUT HEALTHCARE X + 250MG PHARMACEUTICALS PVT ORDINARY 10.0
ICALS PVT. (U) LIMITED MAGNESIUM +250MG LIMITED-NO. C-4, SIDCO TABLETS TABLET
LTD HYDROXIDE +250MG + PHARMACEUTICAL BLISTER
+ALUMINIUM 125MG COMPLEX, ALATHUR,
HYDROXIDE + THIRUPORUR,
SIMETHICONE
1005 NDA/MAL/H CADILA ABACUS ATORVA 40 ATORVASTATI 40MG CADILA HEALTH CARE LTD- INDIA ORAL SOLID 1.0X3.0X1 7/1/2012
DP/1929 HEALTHCARE PHARMA N KUNDAIM INDUSTRIAL ORDINARY 0.0
LIMITED 213, KUNDAIM,GOA-403 BLISTER
115, INDIA
1006 NDA/MAL/H ASTRAZENEC MACNAUGHTON ZOLADEX GOSERELIN 10.8MG ASTRA ZENECA UK UNITED PARENTERAL 1.0X10.8 7/1/2010
DP/1931 A LIMITED LA ACETATE LIMITED-ASTRAZENECA UK KINGDOM RETARD PRE- MG
LIMITED SILK ROAD FILLED IMPLANT
BUSINESS PARK, MACCLES SYRINGES
2NA,
1007 NDA/MAL/H ELYS VELVET CANDISTAT CLOTRIMAZO 1%W/W ELYS CHEMICAL KENYA ORAL 1.0X20.0 7/1/2001
DP/1932 CHEMICAL PHARMA CREAM LE INDUSTRIES LIMITED- TOPICAL G TUBE
INDUSTRIES LIMITED ROAD B’, OFF ENTERPRISE CREAMS
LTD ROAD
PLOT NO. 209/8927
INDUSTRIAL AREA
1008 NDA/MAL/H RENE RENE RENECHLO CHLORAMPH 125MG/5 RENE INDUSTRIES LIMITED- UGANDA ORAL LIQUID 1.0X100.0 7/1/2001
DP/1934 INDUSTRIES INDUSTRIES R ENICOL ML PLOT 680, KAMULI ROAD, ORDINARY ML
LTD LIMITED SUSPENSIO KIREKA SUSPENSION BOTTLE
N S
1009 NDA/MAL/H NABIQASIM JEET SULPHA SULPHANILA 15%W/W NABIQASIM INDUSTRIES PAKISTAN TOPICAL 1.0X1.0X8 7/1/2006
DP/1935 INDUSTRIES PHARMACEUTIC KREAM-N MIDE (PVT) LTD-- EXTERNAL 0.0 G
(PVT) LTD. ALS LIMITED 17/24,KORANGI CREAMS TUBE
INDUSTRIAL AREA,
KORANGI, KARACHI-
PAKISTAN.
1010 NDA/MAL/H GLAXO SMITH UNITED PIRITON CHLORPHENI MULTINGR GLAXO WELLCOME KENYA ORAL LIQUID 1.0X100.0 7/1/1997
DP/1936 KLINE LTD HEALTHCARE EXPECTORA RAMINE EDIENT (KENYA) LTD-KENYA ORDINARY ML
DISTRIBUTORS NT MALEATE + SYRUPS BOTTLE
LTD AMMONIUM
CHLORIDE
1011 NDA/MAL/H AUROBINDO GITTOES EFAVIRENZ EFAVIRENZ 600MG AUROBINDO PHARMA INDIA ORAL SOLID 1.0X30.0 7/1/2005
DP/1937 PHARMA LTD PHARMACEUTIC LIMITED (UNIT III) -AURO ORDINARY TABLET
ALS LIMITED HOUSE, 313, BUCHUPALLY, TABLETS CONTAIN
QUTHUBULLAPAR(M), RR ER
DISTRICT HYDERABAD-
500090, ANDHERA
PRADESH, INDIA.
1012 NDA/MAL/H REMEDICA GOODMAN CLOXACILLI CLOXACILLIN 250MG REMEDICA LTD-AHARNON CYPRUS ORAL SOLID 10.0X10.0 7/1/2001
DP/1940 LTD INTERNATIONAL N SODIUM STREET, LIMASSOL ORDINARY CAPSULE
LTD CAPSULES INDUSTRIAL ESTATE, 3056 CAPSULES BLISTER
LIMASSOL
1013 NDA/MAL/H CADILA KARURI RABELOC IV RABEPRAZOL 20MG/VIA CADILA INDIA PARENTERAL 1.0X5.0 7/1/2005
DP/1941 PHARMACEUT PHARMACEUTIC E L PHARMACEUTICALS ORDINARY ML VIAL
ICALS ALS LTD. LIMITED-1389, TRASAD VIALS
STATE, INDIA
1014 NDA/MAL/H RENE RENE AMCLOREN AMPICILLIN + 250 MG + RENE INDUSTRIES LIMITED- UGANDA ORAL SOLID 1.0X100.0 7/1/2009
DP/1942 INDUSTRIES INDUSTRIES CLOXACILLIN 250 MG PLOT 680, KAMULI ROAD, ORDINARY CAPSULE
LTD LIMITED KIREKA CAPSULES CONTAIN
ER
1015 NDA/MAL/H MODI MUNDI SURGIPHARM NITROCON NITROGLYCER 2.6MG MODI MUNDIPHARMA INDIA ORAL SOLID 1.0X25.0 7/1/2009
DP/1943 PHARMA PVT (U) LIMITED TIN 2.6 IN (PVT) LTD-MEERUT - RETARD TABLET
LTD (CONTROLLE MUZAFFARNAGAR ROAD, TABLETS CONTAIN
D RELEASE) MODIPURAM, UTTAR ER
PRADESH ESTATE
1016 NDA/MAL/H WIN- SURGIPHARM SOLUDOL DICLOFENAC 50MG WIN MEDICARE PVT INDIA ORAL SOLID 10.0X10.0 7/1/1998
DP/1946 MEDICARE (U) LIMITED TABLETS SODIUM LIMITED-MEERUT, ORDINARY TABLET
LTD MUZAFFARNAGER ROAD, SOLUBLE STRIP
MODIPURAM – 250110, TABLETS
UTTAR
PRADESH - INDIA
1017 NDA/MAL/H MACLEODS NORVIK TRENAXA TRANEXAMIC 500MG MACLEODS INDIA ORAL SOLID 1.0X5.0X6 7/1/2011
DP/1949 PHARMACEUT ENTERPRISES 500 ACID PHARMACEUTICALS -PLOT ORDINARY .0 TABLET
ICALS LTDS LIMITED NO. 25-27, SURVEY NO. TABLETS BLISTER
LTD 366, PREMIER INDUSTRIAL
ESTATE, KACHIGAM
DAMAN (UT), INDIA
1018 NDA/MAL/H MACLEODS NORVIK CLOPI 75 CLOPIDOGREL 75MG MACLEODS INDIA ORAL SOLID 1.0X10.0 7/1/2006
DP/1951 PHARMACEUT ENTERPRISES PHARMACEUTICALS -PLOT ORDINARY TABLET
ICALS LTD LIMITED NO. 25-27, SURVEY NO. TABLETS STRIP,3.0X
366, PREMIER INDUSTRIAL 10.0
ESTATE, KACHIGAM TABLET
DAMAN (UT), INDIA STRIP
1019 NDA/MAL/H JOHNSON PHILLIPS NIZORAL KETOCONAZO 20MG/G SPECPHARM HOLDINGS- SOUTH TOPICAL 1.0X80.0 7/1/1997
DP/1952 &JOHNSON PHARMACEUTIC LE 15TH ROAD HALFWAY AFRICA EXTERNAL ML
(PTY) LTD ALS (UGANDA) HOUSE LIQUID BOTTLE
LIMITED SOAPS/WAS
HES
1020 NDA/MAL/H UNIQUE TATA UGANDA RANTAB- RANITIDINE 150MG UNIQUE INDIA ORAL SOLID 1.0X10.0X 7/1/1997
DP/1953 PHARMACEUT LIMITED 150 PHARMACEUTICAL ORDINARY 10.0
ICALS LABORATORIES (A DIV. OF TABLETS TABLET
LABORATORIE J.B CHEMICALS & BLISTER
S PHARMACEUTICALS LTD)--
216-219 GIDC INDUSTRIAL
AREA PANOLI 394 116
DIST BHARUCH
1021 NDA/MAL/H : ALKEM ABACUS RAPEED-20 RABEPRAZOL 20MG ALKEM LABORATORIES INDIA ORAL SOLID 1.0X3.0X1 7/1/2011
DP/1954 LABORATORIE PHARMA E LTD .-VILLAGE THANA, ORDINARY 0.0
S LIMITED√ (AFRICA) BADDI, TEHSIL- TABLETS TABLET
LIMITED NALAGARH, DISTT-SOLAN, STRIP,1.0X
(HP), INDIA-173205 1.0X10.0
TABLET
STRIP
1022 NDA/MAL/H MILAN GITTOES MILOXY AMOXYCILLIN 250MG MILAN LABORATORIES - INDIA ORAL SOLID 1.0X10.0X 7/1/2006
DP/1956 LABORATORIE PHARMACEUTIC PLOT NOS 63, 67 & 87, ORDINARY 10.0
S LTD ALS LIMITED JAWAHAR CO-OP. CAPSULES CAPSULE
INDUSTRIAL BLISTER,1.
ESTATE LTD., 0X1000.0
KAMOTHE, PANVEL (NAVI CAPSULE
MUMBAI). CONTAIN
ER
1023 NDA/MAL/H MILAN GITTOES MILOXY AMOXYCILLIN 125MG/5 MILAN LABORATORIES - INDIA ORAL LIQUID 1.0X100.0 7/1/2005
DP/1958 LABORATORIE PHARMACEUTIC ML PLOT NOS 63, 67 & 87, ORDINARY ML
S LTD ALS LIMITED JAWAHAR CO-OP. SUSPENSION BOTTLE
INDUSTRIAL S
ESTATE LTD.,
KAMOTHE, PANVEL (NAVI
MUMBAI).
1024 NDA/MAL/H MILAN GITTOES BETRIM CO- 480MG MILAN LABORATORIES - INDIA ORAL SOLID 1.0X1000. 7/1/2005
DP/1959 LABERATORIE PHARMACEUTIC 480 TRIMOXAZOL PLOT NOS 63, 67 & 87, ORDINARY 0 TABLET
S PVT LTD ALS LIMITED E JAWAHAR CO-OP. TABLETS CONTAIN
INDUSTRIAL ER,1.0X10
ESTATE LTD., .0X10.0
KAMOTHE, PANVEL (NAVI TABLET
MUMBAI). BLISTER
1025 NDA/MAL/H KAMPALA KAMPALA DIFENAC DICLOFENAC 50MG KAMPALA UGANDA ORAL SOLID 1.0X10.0X 7/1/2003
DP/1960 PHARMACEUT PHARMACEUTIC SODIUM PHARMACEUTICAL ORDINARY 10.0
ICAL AL INDUSTRIES INDUSTRIES (1996) LTD - TABLETS TABLET
INDUSTRIES 1996 LIMITED PLOT NO. M444B, BLISTER
(1996) LTD STRETCHER ROAD,
NTINDA, KAMPALA
1026 NDA/MAL/H BETA BETA NIMBEX CISATRACURI 2MG/ML GLAXOSMITHKLINE S.P.A - ITALY PARENTERAL 1.0X10.0 7/1/1997
DP/1962 HEALTHCARE HEALTHCARE UM BESYLATE STRADA PROVINCIALE ORDINARY ML
UGANDA UGANDA ASOLANA 9 VIALS VIAL,1.0X
LIMITED LIMITED 2.5 ML
VIAL
1027 NDA/MAL/H MILAN GITTOES CLONEX CLOTRIMAZO 1%W/W MILAN LABORATORIES - INDIA TOPICAL 1.0X20.0 7/1/2007
DP/1964 LABORATORIE PHARMACEUTIC LE PLOT NOS 63, 67 & 87, EXTERNAL G TUBE
S LTD ALS LIMITED JAWAHAR CO-OP. CREAMS
INDUSTRIAL
ESTATE LTD.,
MUMBAI).
1028 NDA/MAL/H MACK SHURIK LTD PARACIN PARACETAM 500MG TORQUE INDIA ORAL SOLID 1.0X1000. 7/1/2005
DP/1966 BROWN OL PHARMACEUTICALS LTD- ORDINARY 0 TABLET
PHARMACEUT ISSAPUR P.O DAPPAR TABLETS CONTAIN
ICALS PVT 140506 ER,1.0X10
LIMITED .0X10.0
TABLET
BLISTER
1029 NDA/MAL/H NOVARTIS SURGIPHARM VOLTAREN DICLOFENAC 75MG NOVARTIS PHARMA SPA, ITALY ORAL SOLID 1.0X30.0 7/1/1997
DP/1969 PHARMA AG (U) LIMITED SR 75MG SODIUM TORRE ANNUNZIATA RETARD TABLET
ITALY-NA TABLETS CONTAIN
ER
1030 NDA/MAL/H MACK SHURIK LTD CETRAMAC CETIRIZINE 10MG TORQUE INDIA ORAL SOLID 1.0X10.0X 7/1/2005
DP/1970 BROWN PHARMACEUTICALS LTD - ORDINARY 10.0
PHARMACEUT ISSAPUR P.O DAPPAR TABLETS TABLET
ICALS PVT 140506 BLISTER
LIMITED
1031 NDA/MAL/H GITTOES GITTOES AGOMPICL AMPICILLIN + 125 MILAN LABORATORIES INDIA ORAL LIQUID 1.0X100.0 7/1/1998
DP/1971 PHARMACEUT PHARMACEUTIC OX ORAL CLOXACILLIN MG/5ML + (INDIA ) PVT LTD-PLOT ORDINARY ML
ICALS LIMITED ALS LIMITED SUSPENSIO 125 NO.63-67 & 87,JAWAHAR DRY BOTTLE
N MG/5ML CO.OP.INDUSTRIAL SUSPENSION
ESTATE LTD S/SYRUPS/D
KAMOTHE,PANVEL DIST. ROPS
THANE,MAHARASTRA-
410209,INDIA
1032 NDA/MAL/H SAKAR ROYAL PHARMA CEFROTIL CEFUROXIME 500MG SAKAR HEALTH CARE PVT, INDIA ORAL SOLID 1.0X10.0 7/1/2013
DP/1974 HEALTH CARE 2011 LIMITED AXETIL LTD-BLOCK NO. 10-13,M.N ORDINARY TABLET
PVT .LTD DESAI PETROL TABLETS BLISTER
PUMP,SARKHEJ-BAVLA
ROAD,VILLAGE
CHANGODAR DIST
AHMEDABAD 382-
213,GUJARAT-INDIA
1033 NDA/MAL/H LINCOLN METRO BET- BETAMETHAS 0.1 W/W + LINCOLN INDIA TOPICAL 1.0X15.0 7/1/2007
DP/1975 PHARMACEUT PHARMACEUTIC CODERM N ONE + 0.5 W/W PHARMACEUTICALS LTD- EXTERNAL G TUBE
ICALS LTD ALS LIMITED NEOMYCIN 10, 11, 13, TRIMUL ESTATE CREAMS
KHATRAJ, NEAR
KHATRAJ, CHOKADI ,
KHATRAJ-382721,
GHANDINAGARGUJARAT,
INDIA
1034 NDA/MAL/H UNICHEM EUROPA LOSAR-H LOSARTAN + 50MG + UNICHEM LABORATORIES INDIA ORAL SOLID 1.0X3.0X1 7/1/2011
DP/1977 LABORATORIE HEALTHCARE HYDROCHLOR 12.5MG LIMITED-UNICHEM ORDINARY 0.0
S LTD (U) LTD OTHIAZIDE LABORATORIES LIMITED. TABLETS TABLET
UNIT II, VILLAGE BLISTER
BHATAULI KALAN, BADDI,
DIST. SOLAN PIN CODE
173 205, HIMACHAL
PRADESH, INDIA
1035 NDA/MAL/H ELI-LILLY LABOREX CIALIS TADALAFIL 20MG LILLY SA, AVDA DE LA SPAIN ORAL SOLID 2.0X2.0 7/1/2004
DP/1984 (SUISSE) SA UGANDA INDUSTRIA-LILLY SA, AVDA ORDINARY TABLET
LIMITED DE LA INDUSTRIA, 30 TABLETS BLISTER
28108 ALCOBENDAS -
MADRID
1036 NDA/MAL/H FERRER LABOREX DERMOFIX SERTACONAZ 2%W/W FERRER INTERNATIONAL, SPAIN TOPICAL 1.0X20.0 7/1/2014
DP/1989 INTERNACION UGANDA OLE NITRATE S.A.-C/JOAN BUSCALLA, 1- EXTERNAL G TUBE
AL S.A LIMITED 9.08173 SANT CUGAT DEL CREAMS
VALLES, BARCELONA
1037 NDA/MAL/H UNICHEM PHILLIPS TAGERA SECNIDAZOLE 1G UNICHEM LABORATORIES INDIA ORAL SOLID 1.0X10.0X 7/1/2005
DP/1990 LABORATORIE PHARMACEUTIC FORTE LTD---C31 & 32 ORDINARY 1.0X2.0
S LTD ALS (UGANDA) INDUSTRIAL AREA TABLETS TABLET
LIMITED BLISTER
1038 NDA/MAL/H GITTOES GITTOES TENA-100 ATENOLOL 100MG AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1.0X10.0X 7/1/2011
PADA,VASAI(E)DIST.THAN 0X3.0X10.
E INDIA 0 TABLET
BLISTER,1.
0X2.0X14.
0 TABLET
BLISTER
1039 NDA/MAL/H M.J.BIOPHAR TATA UGANDA TEICO 500 CEFEPIME 500MG M.J BIOPHARM PVT LTD -- INDIA PARENTERAL 1.0X500.0 7/1/2013
DP/1998 M PVT LTD LIMITED L-7 MIDC INDUSTRIAL ORDINARY MG VIAL
AREA, DIST . RAIGAD , DRY VIALS
TALOJA , NAVI MUMBAI
1040 NDA/MAL/H TORRENT KARURI CARBATOL CARBAMAZEP 200MG TORRENT INDIA ORAL SOLID 1.0X1000. 7/1/2000
DP/1999 PHARAMACE PHARMACEUTIC 200 INE PHARMACEUTICALS LTD- ORDINARY 0 TABLET
UTICALS LTD ALS LTD. INDRAD-382721, TAL KADI, TABLETS CONTAIN
AHMEDABAD, INDIA ER,2.0X5.
0X10.0
TABLET
BLISTER
1041 NDA/MAL/H TORRENT KARURI CALCIGARD NIFEDIPINE(S 20MG TORRENT INDIA ORAL SOLID 10.0X10.0 7/1/2000
DP/2000 PHARAMACE PHARMACEUTIC RETARD R) PHARMACEUTICALS LTD- RETARD TABLET
UTICALS LTD ALS LTD. INDRAD-382721, TAL KADI, TABLETS BLISTER
AHMEDABAD, INDIA
1042 NDA/MAL/H MEDLEY MEDVIN R.B.TONE FERROUS 200MG + MEDLEY INDIA ORAL SOLID 1.0X10.0X 7/1/2008
DP/2004 PHARMACEUT PHARMA GLUCONATE 38MG + PHARMACEUTICALS LTD- ORDINARY 15.0
ICALS LTD LIMITED + VITAMIN C 4MCG + PLOT NO.18 AND 19, CAPSULES CAPSULE
+ VITAMIN 3MG + SURVEY NO.378/8 & BLISTER
B12 + 2.5MG + 379/2, KEBRA INDUSTRIAL
VITAMIN B1 + 1MG + ESTATE, KACHIGAM,
VITAMIN B2 + 2.5MG + DAMAN-396210 INDIA
VITAMIN B6 + 1MG +
CALCIUM 2.5MG +
PANTOTHENA 23MG +
TE + VITAMIN 0.5MG +
B3 + FOLIC 100MG +
1043 NDA/MAL/H AJANTA ABACUS KAMAGRA- SILDENAFIL 100MG AJANTA PHARMA LIMITED INDIA ORAL SOLID 1.0X1.0X4 7/1/2005
DP/2005 PHARMA LTD PHARMA 100 CITRATE PAITHAN- ORDINARY .0 TABLET
(AFRICA) MANUFACTURING UNIT B- TABLETS BLISTER
LIMITED 4/5/6 MIDC PAITHAN
DISTRICT AURANGABAD
431 148 MAHARASTRA
STATE INDIA
1044 NDA/MAL/H GITTOES GITTOES B-COX VITAMIN B BCP AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1.0X1000. 7/1/2001
DP/2007 PHARMACEUT PHARMACEUTIC TABLETS COMPLEX FORMULA NO.33,SECTOR ORDINARY 0 TABLET
OP ESTATE LTD,GAURAI ER
E INDIA
1045 NDA/MAL/H GLENMARK STAR CANDID -B- CLOTRIMAZO 1%W/W + GLENMARK INDIA TOPICAL 1.0X15.0 7/1/2004
DP/2008 PHARMACUTI PHARMACEUTIC CREAM LE + 0.025%W/ PHARMACEUTICALS LTD- EXTERNAL G TUBE
CALS LTD ALS LTD BECLOMETAS W PLOT NO E -37, 39 ,D CREAMS
ONE
DIPROPRION
ATE CREAM
1046 NDA/MAL/H COSMOS LTD ASTRA PHARMA ZITHROX AZITHROMYCI 200MG/5 COSMOS LTD.-RANGWE KENYA ORAL LIQUID 1.0X15.0 7/1/2010
DP/2009 (U) LIMITED N ML ROAD; OFF LUNGA LUNGA ORDINARY ML
ROAD. P.O BOX 414 33, DRY BOTTLE,1.
NAIROBI SUSPENSION 0X30.0 ML
S/SYRUPS/D BOTTLE
ROPS
1047 NDA/MAL/H HETERO LABS AIVEEN (U) GIAGRA 50 SILDENAFIL 50MG HETERO LABS LTD. UNIT INDIA ORAL SOLID 1.0X4.0 7/1/2013
DP/2011 LTD LIMITED CITRATE (V) .-S.N0.439, 440, 441& ORDINARY TABLET
458, APIIC, PHARMA SEZ, TABLETS BLISTER,1.
POLLEPALLY (VILLAGE), 0X10.0X1.
JADCHERLA (MANDAL) 0X4.0
MAHABOOB NAGAR (DIST)- TABLET
509301 INDIA. BLISTER
1048 NDA/MAL/H GLENMARK STAR CANDID -B- CLOTRIMAZO 1%W/V + GLENMARK INDIA TOPICAL 1.0X15.0 7/1/2004
DP/2012 PHARMACUTI PHARMACEUTIC LOTION LE + 0.025%W/ PHARMACEUTICALS LTD- EXTERNAL ML
CALS LTD ALS LTD BECLOMETHA V PLOT NO E -37, 39 ,D LOTIONS BOTTLE
SONE
DIPROPIONAT
E
1049 NDA/MAL/H SK AGE ABACUS CANI-MAKS CLOTRIMAZO 1%W/W S KANT HEALTHCARE LTD- INDIA TOPICAL 1.0X1.0X1 7/1/2009
DP/2014 EXPORTS PHARMA LE 1802-1805 GIDC OHASE II EXTERNAL 5.0 G
(AFRICA) VAPS-396195, GUJARAT, CREAMS TUBE
LIMITED INDIA
1050 NDA/MAL/H GLENMARK STAR CANDID CLOTRIMAZO 1%W/W GLENMARK INDIA TOPICAL 1.0X20.0 7/1/2000
DP/2016 PHARMACUTI PHARMACEUTIC CREAM LE PHARMACEUTICALS LTD- EXTERNAL G TUBE
CALS LTD ALS LTD PLOT NO E -37, 39 ,D CREAMS
1051 NDA/MAL/H CENTAUR GITTOES ORAXIN CYPROHEPTA 2MG+275 CENTAUR INDIA ORAL LIQUID 1.0X200.0 7/1/1997
DP/2018 PHARMACEUT PHARMACEUTIC SYRUP DINE+TRICHO MG PHARMACEUTICALS LTD,-- ORDINARY ML
ICALS LTD ALS LIMITED LINE CITRATE KARASWADA MAPUSA SYRUPS BOTTLE,1.
GOA 0X100.0
ML
BOTTLE
1052 NDA/MAL/H GITTOES GITTOES AGOHAL HALOPERIDO 10MG AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1.0X10.0X 7/1/2011
DP/2019 PHARMACEUT PHARMACEUTIC L NO.33,SECTOR ORDINARY 10.0
E INDIA
1053 NDA/MAL/H KAMPALA KAMPALA QUINE QUININE 300MG KAMPALA UGANDA ORAL SOLID 1.0X10.0 7/1/1997
DP/2020 PHARMACEUT PHARMACEUTIC SULPHATE PHARMACEUTICAL ORDINARY TABLET
ICAL AL INDUSTRIES INDUSTRIES (1996) TABLETS BLISTER,1.
INDUSTRIES 1996 LIMITED LIMITED - -STRETCHER 0X1000.0
1996 LIMITED ROAD PLOT M444B TABLET
NTINDA KAMPALA CONTAIN
ER,1.0X50
0.0
TABLET
CONTAIN
ER,1.0X10
0.0
1054 NDA/MAL/H PHARCO WIDE PREGVIT MULTIVITAMI MULT- PHARCO EGYPT ORAL SOLID 1.0X12.0X 7/1/2000
DP/2021 PHARMACEUT SPECTRUM ZINC N/MINERALS INGREDIEN PHARMACEUTICALS LTD- ORDINARY 2.0
ICALS ENTERPRISES T KILO 31 ALEXANDRIA, CAPSULES CAPSULE
ALEXANDRIA EGYPT
1055 NDA/MAL/H MACK SHURIK LTD TORACTIN CYPROHEPTA 2MG/5ML TORQUE INDIA ORAL LIQUID 1.0X100.0 7/1/1997
DP/2022 BROWN DINE PHARMACEUTICALS LTD- ORDINARY ML
PHARMACEUT ISSAPUR P.O DAPPAR SYRUPS BOTTLE,1.
ICALS PVT 140506 0X60.0 ML
LIMITED BOTTLE
1056 NDA/MAL/H TORRENT KARURI NEXPRO - ESOMEPRAZO 40MG TORRENT INDIA ORAL SOLID 1.0X10.0X 7/1/2004
DP/2024 PHARMACEUT PHARMACEUTIC 40 LE PHARMACEUTICALS LTD- ORDINARY 10.0
ICALS LTD ALS LTD. MAGNESIUM INDRAD-382 721, TABLETS TABLET
TABLET DIST.MEHSANA,INDIA.AT: STRIP
VILL.MANAKPUR,TEH.NAL
AGARH,DIST.SOLAN(H.P.)
1057 NDA/MAL/H REGAL REGAL PHARMA FERRO-B MULTI- MULTI- REGAL KENYA ORAL LIQUID 1.0X60.0 7/1/1997
DP/2025 PHARMACEUT (U) LTD COMPLEX INGREDIENT INGREDIEN PHARMACEUTICALS LTD- ORDINARY ML
ICALS LTD SYRUP T BABA DOGO ROAD, SYRUPS BOTTLE,1.
ML
BOTTLE
1058 NDA/MAL/H BROOKES HARLEYS CORAM AMLODIPINE 10MG BROOKES PAKISTAN ORAL SOLID 1.0X2.0X1 7/1/2009
DP/2026 PHARMACEUT UGANDA 10MG BESYLATE PHARMACEUTICALS ORDINARY 0.0
ICAL LIMITED LABORATORIES TABLETS TABLET
LABORATORIE (PAKISTAN) LTD-PLOT 58 BLISTER,1.
SL SECTOR 15 KORANGI 0X10.0X10
INDUSTRIAL AREA, .0 TABLET
KARACHI-PAKISTAN BLISTER,1.
0X3.0X10.
0 TABLET
BLISTER
1059 NDA/MAL/H UNITED WIDE CO- VALSARTAN + 160MG + UNITED JORDAN ORAL SOLID 1.0X3.0X1 7/1/2013
DP/2027 PHARMACEUT SPECTRUM ANGINET HYDROCHLOR 12.5MG PHARMACEUTICAL ORDINARY 0.0
ICAL ENTERPRISES 160/12.5M OTHIAZIDE MANUFACTURING TABLETS TABLET
MANUFACTU (U) LIMITED G COMPANY LTD-P.O BOX BLISTER
RING 69 AMMAN 11591
SECURITY HOUSING
1060 NDA/MAL/H ABACUS ABACUS CHLORAMP CHLORAMPH 125MG/5 MEDICAMEN BIOTECH LTD- INDIA ORAL LIQUID 1.0X100.0 7/1/2014
DP/2029 PHARMA (A) PHARMA HENICOL ENICOL ML SP-1192, A &B, PHASE –IV, ORDINARY ML
LTD. (AFRICA) PALMITATE PALMITATE INDUSTRIAL AREA SUSPENSION BOTTLE
LIMITED BHIWADI -301019 DIST. S
ALWAR (RAJASTHAN)
1061 NDA/MAL/H GITTOES GITTOES AGOZID ISONIAZID 100MG AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1.0X1000. 7/1/2004
DP/2031 PHARMACEUT PHARMACEUTIC TABLETS NO.33,SECTOR ORDINARY 0 TABLET
E INDIA TABLET
BLISTER
1062 NDA/MAL/H MICRO LABS PHILLIPS ANGIZAAR- LOSARTAN 50MG MICRO LABS LTD-92, INDIA ORAL SOLID 1.0X3.0X1 7/1/2009
DP/2033 LTD PHARMACEUTIC 50 POTASSIUM SIPCOT INDUSTRIAL ORDINARY 0.0
ALS (UGANDA) COMPLEX HOSU R-635126 FILM- TABLET
LIMITED (T.N) INDIA COATED STRIP
TABLETS
1063 NDA/MAL/H KAMPALA KAMPALA NEOSIDAR SULPHADOXI 500MG + KAMPALA UGANDA ORAL SOLID 1.0X25.0X 7/1/2004
DP/2035 PHARMACEUT PHARMACEUTIC NE + 25MG PHARMACEUTICAL ORDINARY 3.0
ICAL AL INDUSTRIES PYRIMETHAM INDUSTRIES (1996) TABLETS TABLET
INDUSTRIES 1996 LIMITED INE LIMITED - -STRETCHER BLISTER,1.
(1996) LTD ROAD PLOT M444B 0X50.0X3.
NTINDA KAMPALA 0 TABLET
BLISTER
1064 NDA/MAL/H ELI-LILLY LABOREX HUMULIN HUMAN 100IU ELI LILLY & COMPANY- FRANCE PARENTERAL 1.0X10.0 7/1/1998
DP/2036 (SUISSE) SA UGANDA REGULAR INSULIN LILLY TECHNOLOGY ORDINARY S ML
LIMITED CENTER, 1555 S HARDING, C VIALS VIAL,1.0X
INDIANAPOLIS, INDIANA, 5.0X3.0
46221 LILLY FRANCE SA- ML
FRANCE CARTRIDG
E
1065 NDA/MAL/H GITTOES GITTOES RANITIDINE RANITIDINE 25MG/ML NINGBO DAHONGYING CHINA PARENTERAL 1.0X1.0X1 7/1/2011
DP/2039 PHARMACEUT PHARMACEUTIC INJECTION PHARMACEUTICALS LTD- ORDINARY 0.0X2.0
ICALS LIMITED ALS LIMITED USP NO. 396 MIN AMPOULES ML
AMPOULE
1066 NDA/MAL/H AJANTA ABACUS ARTEFAN ARTEMETHER 20 MG + AJANTA PHARMA LIMITED INDIA ORAL SOLID 1.0X30.0X 7/1/2006
DP/2040 PHARMA PHARMA 20/120 + 120 MG PAITHAN- ORDINARY 12.0
LIMITED (AFRICA) LUMEFANTRI MANUFACTURING UNIT B- TABLETS TABLET
LIMITED NE 4/5/6 MIDC PAITHAN BLISTER,1.
DISTRICT AURANGABAD 0X3.0X8.0
431 148 MAHARASTRA TABLET
STATE INDIA BLISTER,1.
0X30.0X24
.0 TABLET
BLISTER,1.
0X30.0X18
.0 TABLET
1067 NDA/MAL/H IDA KIMSY MEDS OXYTOCIN OXYTOCIN 10IU GLAND PHARMA LIMITTED INDIA PARENTERAL 1.0X10.0X 7/1/2005
DP/2041 LTD 143-148-D P PALLY, ORDINARY 1.0 ML
QUTHUBULLAPUL AMPOULES AMPOULE
MANDAL, RANDA REDDY ,1.0X1.0X1
DIST, HYBERABAD, IN-500 0.0X1.0X1
043, INDIA GLAND 0.0 ML
PHARMA LTD-PLOT NO. 42 AMPOULE
TO 52, SY NO. 166, 171, ,1.0X10.0X
172 & 177, TSIIC, PHASE 1.0X10.0X
III, PASHAMYLARAM (V) 1.0 ML
PATANCHERU (M), MEDAK AMPOULE
DISTRICT 502307,
1068 NDA/MAL/H SHOSAAN RENE BURNCURE SILVER 1%W/W NEM LABORATORIES PVT INDIA TOPICAL 1.0X200.0 7/1/1997
DP/2042 ASIC PACIFIC PHARMACY LTD SULFADIAZIN LTD-133 VASAI RD(E) 401 EXTERNAL G
E 162 SB MARG. LOWER CREAMS TUBE,1.0X
PAREL MUMBAI 15.0 G
TUBE
1069 NDA/MAL/H COSMOS LTD ASTRA PHARMA DIASTOP ATTAPULGITE N/A COSMOS LTD.-RANGWE KENYA ORAL SOLID 1.0X25.0X 7/1/1998
DP/2043 (U) LIMITED TABLETS / ALUMINIUM ROAD; OFF LUNGA LUNGA ORDINARY 4.0
HYDROXIDE ROAD. P.O BOX 414 33, TABLETS TABLET
NAIROBI STRIP
1070 NDA/MAL/H ELDA REDDYS BUPICAN BUPIVACAINE 0.5% W/V CLARIS INJECTABLES INDIA PARENTERAL 1.0X20.0 7/1/2006
DP/2045 INTERNATION PHARMA LIMITED---CHACHARWADI ORDINARY ML VIAL
AL DMCC LIMITED VASANA 382 213 VIALS
AHMEDABAD GUJARAT
1071 NDA/MAL/H COSMOS LTD ASTRA PHARMA LORHISTIN LORATADINE 10MG COSMOS LTD.-RANGWE KENYA ORAL SOLID 1.0X3.0X1 7/1/2005
DP/2046 (U) LIMITED A ROAD; OFF LUNGA LUNGA ORDINARY 0.0
ROAD. P.O BOX 414 33, TABLETS TABLET
NAIROBI BLISTER
1072 NDA/MAL/H MYLAN KIMSY MEDS RITONAVIR RITONAVIR 100MG MYLAN LABORATORIES INDIA ORAL SOLID 1.0X120.0 7/1/2011
DP/2047 LABORATORIE LTD LTD--F-4,F-12 MALEGAON ORDINARY TABLET
422113 MAHARASHTRA ER,1.0X30
STATE .0 TABLET
BOTTLE
1073 NDA/MAL/H WOCKHARDT STAR KEFSTAR- CEFUROXIME 500MG SANCE LABORATORIES INDIA ORAL SOLID 1.0X1.0X4 7/1/2005
DP/2049 LTD PHARMACEUTIC 500 AXETIL PVT LTD-VI/51B, P.B. ORDINARY .0 TABLET
ALS LTD NO.2, KOZHUVANAL, TABLETS STRIP,1.0X
PALA, KOTTAYAM 1.0X10.0
DISTRICT-686573, TABLET
KERALA, INDIA. BLISTER
1074 NDA/MAL/H GLAXO SMITH UNITED PIRITON CHLORPHENI 4MG GLAXO WELLCOME KENYA ORAL SOLID 1.0X10.0 7/1/1997
DP/2051 KLINE LTD HEALTHCARE TABLETS RAMINE (KENYA) LTD-KENYA ORDINARY TABLET
DISTRIBUTORS MALEATE TABLETS BLISTER,1.
LTD 0X1000.0
TABLET
CONTAIN
ER
1075 NDA/MAL/H EMCURE HARLEYS ASOMEX-5 AMLODIPINE 5MG EMCURE INDIA ORAL SOLID 1.0X5.0X1 7/1/2005
DP/2053 PHARMACEUT UGANDA BESILATE PHARMACEUTICALS LTD - ORDINARY 0.0
ICALS LTD LIMITED LANE NO.3 PHASE II,SIDCO TABLETS TABLET
INDUSTRIAL BLISTER
COMPLEX,BARI-
BRAHMANA JAMMU 181
133, INDIA
1076 NDA/MAL/H GUILIN STAR ARTESUN ARTESUNATE 120MG GUILIN PHARMACEUTICAL CHINA PARENTERAL 1.0X120.0 7/1/2011
DP/2055 PHARMACEUT PHARMACEUTIC CO. LTD.-NO. 43 QILIDIAN ORDINARY MG VIAL +
ICALS CO.LTD ALS LTD ROAD, GUILIN 541004 DRY VIALS 1 *2 ML
AMPOULE
OF 5%
SODIUM
BICARBO
NATE
SOLUTION
+ 1*10 ML
AMPOULE
OF 0.9%
1077 NDA/MAL/H WOCKHARDT STAR BRO-ZEDEX TERBUTALINE 1.25MG+ 4 WOCKHARDT LIMITED -- INDIA ORAL LIQUID 1.0X100.0 7/1/1997
DP/2056 LTD PHARMACEUTIC SULPHATE MG+50 PLOT 57 VILLAGE ORDINARY ML
ALS LTD +BROMHEXIN MG+2.5 KUNJHAL, JHAMAJRI, SYRUPS BOTTLE
E MG/5 ML BAROTIWALA, BADDI,
HYDROCHLOR TEHSIL-NALAGARH,
IDE+GUAIPHE DISTRICT SOLAN, 174103
NESIN+MENT HIMACHAL PRADESH,
HOL INDIA
1078 NDA/MAL/H MACLEODS NORVIK QUININE QUININE 300MG MACLEODS INDIA ORAL SOLID 1.0X10.0X 7/1/2006
DP/2058 PHARMACEUT ENTERPRISES SULPHATE SULPHATE PHARMACEUTICALS -PLOT ORDINARY 10.0
ICALS LTD LIMITED NO. 25-27, SURVEY NO. TABLETS TABLET
366, PREMIER INDUSTRIAL BLISTER,1.
ESTATE, KACHIGAM 0X1000.0
DAMAN (UT), INDIA TABLET
CONTAIN
ER
1079 NDA/MAL/H BAYER SURGIPHARM MICROGYN LEVONORGES 0.15MG / BAYER PHARMA A.G- GERMANY ORAL SOLID 1.0X1.0X2 7/1/1997
DP/2063 PHARMA AG (U) LIMITED ON FE TREL / 0.03MG MULLERSTRASSE 178, ORDINARY 8.0
ETHINYLESTR 13353 BERLIN, GERMANY TABLETS TABLET
ADIOL. BLISTER
1080 NDA/MAL/H REMEDICA GOODMAN METHOTRE METHOTREXA 2.5MG REMEDICA LIMITED- CYPRUS ORAL SOLID 1.0X10.0X 7/1/2005
DP/2066 LTD INTERNATIONAL XATE TE LIMASSOL INDUSTRIAL ORDINARY 10.0
LTD ESTATE, AHAR TABLETS TABLET
BLISTER
1081 NDA/MAL/H UNICHEM EUROPA ZYNCET CETIRIZINE 10MG UNICHEM LABORATORIES INDIA ORAL SOLID 1.0X4.0X5 7/1/1999
DP/2067 LABORATORIE HEALTHCARE DIHYDROCHL LIMITED UNIT II-VILLAGE ORDINARY .0X10.0
S LTD (U) LTD ORIDE BHATAULI KALAN BADDI TABLETS TABLET
DIST SOLAN HIMACHAL BLISTER
PRADESH 173 205
1082 NDA/MAL/H UNICHEM EUROPA DOMADOL TRAMADOL 50MG UNICHEM LABORATORIES INDIA ORAL SOLID 1.0X10.0X 7/1/1999
DP/2068 LABORATORIE HEALTHCARE HYDROCHLOR LIMITED UNIT II-VILLAGE ORDINARY 10.0
S LTD (U) LTD IDE BHATAULI KALAN BADDI CAPSULES CAPSULE
DIST SOLAN HIMACHAL BLISTER
PRADESH 173 205
1083 NDA/MAL/H SK AGE ABACUS SK DERM BETAMETHAS 0.05%W/W S KANT HEALTHCARE LTD- INDIA TOPICAL 1.0X15.0 7/1/2010
DP/2069 EXPORTS PHARMA ONE + + 1%W/W PLOT NO. 1802-1805, EXTERNAL G
(AFRICA) CLOTRIMOXA + G.I.D.C. PHASE III, VAPI CREAMS TUBE,1.0X
LIMITED ZOLE + 0.1%W/W 396 195. GUJARAT. 30.0 G
GENTAMYCIN TUBE
1084 NDA/MAL/H BAYER SURGIPHARM MIRENA LEVONORGES 52MG BAYER OY-PANSIONATE 47 FINLAND PARENTERAL 1.0X1.0 7/1/2009
DP/2070 PHARMA AG (U) LIMITED TREL 20210 TURKU FINLAND RETARD IMPLANT
IMPLANTS CARTON
1085 NDA/MAL/H CADILA KARURI CEFAMOR CEFALEXIN 125MG/5 CADILA INDIA ORAL LIQUID 1.0X100.0 7/1/2000
DP/2071 PHARMACEUT PHARMACEUTIC DRY SYRUP ML PHARMACEUTICALS ORDINARY ML
ICALS LIMITED ALS LTD. LIMITED-1389, TRASAD DRY BOTTLE
ROAD, DHOLKA- 382225, SUSPENSION
DIST: AHMEDAD, GUJARAT S/SYRUPS/D
STATE, INDIA ROPS
1086 NDA/MAL/H SERUM NORVIK SII MEASLES NOT LESS SERUM INSTITUTE OF INDIA PARENTERAL 1.0X1.0 7/1/1997
DP/2073 INSTITUTE OF ENTERPRISES MEASLES VIRUS THAN INDIA LTD-212/2 ORDINARY DOSE VIAL
INDIA LTD. LIMITED VACCINE 1000CCID5 HADAPSAR, PUNE, 411028, DRY VIALS + 0.5ML
LIVE 0/ DOSE INDIA AMPOULE
ATTENUAT OF
ED(FREEZE- STERILE
DRIED) WATER
FOR
INJECTIO
N,1.0X10.
0 DOSE
VIAL +
1087 NDA/MAL/H GITTOES GITTOES AGOXIN AMOXYCILLIN 125MG/5 MILAN LABORATORIES INDIA ORAL LIQUID 1.0X100.0 7/1/1998
DP/2074 PHARMACEUT PHARMACEUTIC ORAL TRIHYDRATE ML (INDIA ) PVT LTD-PLOT NO ORDINARY ML
ICALS LIMITED ALS LIMITED SUSPENSIO 63/67/87 J.C.I.E LTD DRY BOTTLE
N KAMOTHE PANVER, NAVI SUSPENSION
MUMBAI,INDIA S/SYRUPS/D
ROPS
1088 NDA/MAL/H GITTOES GITTOES AGOPRED PREDNISOLO 5MG AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1.0X1000. 7/1/2006
DP/2075 PHARMACEUT PHARMACEUTIC NE NO. 33, SECTOR II, VASAI, ORDINARY 0 TABLET
ICALS LIMITED ALS LIMITED TALUKA INDL. TABLETS CONTAIN
ER,10.0X1
0.0
TABLET
BLISTER
1089 NDA/MAL/H GITTOES GITTOES AGOMIDE FUROSEMIDE 40MG AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1.0X10.0X 7/1/2006
BLISTER,1.
0X1000.0
TABLET
CONTAIN
ER,1.0X10
0.0X10.0
TABLET
BLISTER
1090 NDA/MAL/H ARISTO NORVIK AMBRODIL AMBROXOL 30MG/5ML ARISTO INDIA ORAL LIQUID 1.0X100.0 7/1/2007
DP/2077 PHARMACEUT ENTERPRISES HYDROCHLOR PHARMACEUTICALS PVT. ORDINARY ML
ICALS PVT LTD LIMITED IDE LIMITED-PLOT NO. 208, SYRUPS BOTTLE
NEW INDUSTRIAL AREA
NO.II,MANDIDEEEP
PRADESH
1091 NDA/MAL/H LEBEN ANDYCO ALCLOX CLOXACILLIN 125MG/5 LEBEN LAB PVT LTD-L4 INDIA ORAL LIQUID 1.0X100.0 7/1/2007
DP/2078 LABORATORIE PHARMACY SYRUP SODIUM ML PHASE 111 MIDCS AKOLA ORDINARY ML
S PVT LTD (UGANDA) LTD 444104 MAHARASTRA DRY BOTTLE
INDIA SUSPENSION
S/SYRUPS/D
ROPS
1092 NDA/MAL/H GALENTIC VITACARE NETRAVIR ACICLOVIR 5%W/W GALENTIC PHARMA PVT. INDIA TOPICAL 1.0X5.0 G 7/1/2005
DP/2079 PHARMA LIMITED LIMITED-R-673, TTC MIDC, EXTERNAL TUBE
(PVT)LTD RUBALE, THANE, INDIA CREAMS
1093 NDA/MAL/H GALENTIC VITACARE BETAMETH BETAMETHAS 0.1%W/V GALENTIC PHARMA PVT. INDIA TOPICAL 1.0X15.0 7/1/2009
DP/2080 PHARMA LTD LIMITED ASONE ONE LIMITED-R-673, TTC MIDC, EXTERNAL G
VALERATE VALERATE RUBALE, THANE OINTMENTS TUBE,1.0X
BELAPURNAVI MUMBAI 30.0 G
400 701 TUBE
INDIA
1094 NDA/MAL/H BIOLOGICAL GITTOES BEVAC PURIFIED 20MCG BIOLOGICAL E LTD-PLOT INDIA PARENTERAL 1.0X35.0X 7/1/2015
DP/2083 E. LTD PHARMACEUTIC HEPATITIS B NO.1, S.P ORDINARY 1.0 ML
ALS LIMITED SURFACE BIOTECHNOLOGY PARK, VIALS VIAL (1
ANTIGEN PHASE II KOLTHER (V), DOSE
SHAMEERPET(M), RANGA VIAL),1.0X
REDDY(DIST), ANDHRA 24.0X10.0
PRADESH, INDIA 500078 ML VIAL
(10 DOSE
VIAL)
1095 NDA/MAL/H ABBVIE MEDICAL NORVIR RITONAVIR 100MG ABBVIE DEUTSCHLAND GERMANY ORAL SOLID 1.0X60.0 7/1/2013
DP/2087 LOGISTICS BV ACCESS GMBH & CO. KG.- ORDINARY TABLET
(UGANDA) KNOLLSTASSE 50, D-67061, TABLETS BOTTLE
LIMITED LUDWIGSHAFEN,
GERMANY.
1096 NDA/MAL/H HOVID BHD UNITED DIABETMIN METFORMIN 500MG HOVID BHD-LOT 56442, MALAYSIA ORAL SOLID 1.0X10.0X 7/1/2013
DP/2089 HEALTHCARE XR 500MG HCL 7.5 MILE JALAN ORDINARY 10.0
DISTRIBUTORS EXTENDED IPOH/CHEMO 31200 OTHER TABLET
LTD RELEASE CHEMOR, PERAK COATED BLISTER
MALAYSIA TABLETS
1097 NDA/MAL/H RENE RENE CIPROREN CIPROFLOXAC 500MG RENE INDUSTRIES LTD- UGANDA ORAL SOLID 1.0X10.0X 7/1/2005
DP/2090 INDUSTRIES INDUSTRIES IN PLOT 680, KAMULI ROAD, ORDINARY 10.0
KAMPALA BLISTER
1098 NDA/MAL/H KAMPALA KAMPALA CAMSTON CLOTRIMAZO 1%W/W KPI ( KAMPALA UGANDA TOPICAL 1.0X20.0 7/1/2001
DP/2091 PHARMACEUT PHARMACEUTIC LE PHARMACEUTICAL EXTERNAL G TUBE
ICAL AL INDUSTRIES INDUSTIRES LTD-PLOT CREAMS
INDUSTRIES 1996 LIMITED M444 B STRETCHER ROAD
1996 LIMITED NTINDA
1099 NDA/MAL/H CIPLA LTD. QUALITY DUOVIR-N LAMIVUDINE 150MG + CIPLA LTD.- -PLOT NO INDIA ORAL SOLID 1.0X30.0 7/1/2004
DP/2092 CHEMICALS LTD - + 300MG + L/139 TO L/146, VERNA ORDINARY TABLET
HUMAN ZIDOVUDINE 200MG INDUSTRIAL ESTATE, TABLETS BOTTLE,1.
+ VERNA, SOUTH GOA 0X60.0
NEVIRAPINE DISTRICT, 403722 GOA TABLET
BOTTLE
1100 NDA/MAL/H CADILA KARURI TRIGAN-D PARACETAM 500MG + CADILA INDIA ORAL SOLID 10.0X10.0 7/1/1999
DP/2093 PHARMACEUT PHARMACEUTIC TABLET OL + 20MG PHARMACEUTICALS ORDINARY TABLET
ICALS LIMITED ALS LTD. DICYCLOMINE LIMITED-1389, TRASAD TABLETS STRIP
STATE, INDIA
1101 NDA/MAL/H MICRO LABS LABOREX LEVOBACT- LEVOFLOXACI 750MG MICRO LABS LTD-92, INDIA ORAL SOLID 1.0X1.0X1 7/1/2010
DP/2094 LTD UGANDA 750 N SIPCOT INDUSTRIAL ORDINARY 0.0
LIMITED HEMIHYDRAT COMPLEX HOSU R-635126 FILM- TABLET
E (T.N) INDIA COATED BLISTER
TABLETS
1102 NDA/MAL/H GITTOES GITTOES AGOMOL PARACETAM 100MG AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1.0X1000. 7/1/2010
DP/2095 PHARMACEUT PHARMACEUTIC OL NO.33,SECTOR ORDINARY 0 TABLET
E INDIA
1103 NDA/MAL/H LEBEN ANDYCO ALCLOX CLOXACILLIN 250MG LEBEN LABORATORIES PVT INDIA ORAL SOLID 1.0X1000. 7/1/2011
DP/2097 LABORATORIE PHARMACY LTD --L4 PHASEIII M.I.D.C ORDINARY 0
S PVT LTD (UGANDA) LTD AKOLA 444 104 CAPSULES CAPSULE
MAHARASHTRA CONTAIN
ER,1.0X10
.0X10.0
CAPSULE
BLISTER
1104 NDA/MAL/H GITTOES GITTOES AGO QUININE 300MG AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1.0X1000. 7/1/2006
DP/2098 PHARMACEUT PHARMACEUTIC QUININE SULPHATE NO. 33, SECTOR II, VASAI, ORDINARY 0 TABLET
ICALS LIMITED ALS LIMITED TALUKA INDL. TABLETS CONTAIN
ER,1.0X10
.0X10.0
TABLET
BLISTER
1105 NDA/MAL/H XEPA SOUL DELMAW HYDROCOR HYDROCORTI 1%W/W XEPA-SOUL PATTINSON MALAYSIA TOPICAL 1.0X15.0 7/1/1998
DP/2099 PATTISON (M) ENTERPRISES TISONE 1% SONE (MALAYSIA) SDN BHD-1-5 EXTERNAL G TUBE
SDN BHD LIMITED CREAM CHENG INDUSTRIAL CREAMS
ESTATE, 75250
MALEKA, MALAYSIA
1106 NDA/MAL/H MYLAN KIMSY MEDS ORALCON - LEVONORGES 0.15MG + MYLAN LABORATORIES INDIA ORAL SOLID 1.0X3.0X2 7/1/2007
DP/2100 LABORATORIE LTD F TREL & 0.03MG + LIMITED.--PLOT NO. 1606- ORDINARY 8.0
S LIMITED ETHINYLESTR 75MG 1609, SARIGAM TABLETS TABLET
ADIOL+ INDUSTRIAL AREA, GIDC, BLISTER
FERROUS SARIGAM, TAL-UMERGAM,
FUMARATE DIST VALSAD, 396155,
PLOT NO.20 & 21,
PHARMEZ, SARKHEJ-
BAVLA NATIONAL
1107 NDA/MAL/H COSMOS LTD ASTRA PHARMA CARDISPRI ACETYL 75MG COSMOS LIMITED- KENYA ORAL SOLID 1.0X2.0X1 7/1/2010
DP/2101 (U) LIMITED N SALICYLIC RANGWE ROAD, OFF ORDINARY 4.0
ACID LUNGA ROAD - FILM- TABLET
INDUSTRIAL AREA NAROBI COATED BLISTER
TABLETS
1108 NDA/MAL/H MEDREICH SURGIPHARM FLEMING AMOXYCILLIN 500 MG + MEDREICH LIMITED –UNIT INDIA ORAL SOLID 1.0X2.0X7 7/1/2006
DP/2102 PLC (U) LIMITED 625 + 125 MG I-12TH MILE, OLD MADRAS ORDINARY .0 TABLET
CLAVULANAT ROAD, VIRGONAGAR TABLETS BLISTER
E POTASSIUM
BANGALORE-560 049,
INDIA
1109 NDA/MAL/H MEDREICH SURGIPHARM FLEMING AMOXYCILLIN 875 MG + MEDREICH LIMITED –UNIT INDIA ORAL SOLID 1.0X2.0X7 7/1/2006
DP/2103 PLC (U) LIMITED 1000 TAB + 125 MG I-12TH MILE, OLD MADRAS ORDINARY .0 TABLET
CLAVULANAT ROAD, VIRGONAGAR TABLETS BLISTER
E POTASSIUM
BANGALORE-560 049,
INDIA
1110 NDA/MAL/H MYLAN KIMSY MEDS LAMIVUDIN LAMIVUDINE 30MG + MYLAN LABORATORIES INDIA ORAL SOLID 1.0X60.0 7/1/2009
DP/2104 LABORATORIE LTD E/NEVIRAPI + 50MG + LTD--F-4,F-12 MALEGAON ORDINARY TABLET
S LIMITED NE NEVIRAPINE 60MG MIDC SINNAR NASHIK SOLUBLE BOTTLE
/ZIDOVUDI + 422113 MAHARASHTRA TABLETS
NE ZIDOVUDINE STATE
DISPERSIBL
E TABLETS
1111 NDA/MAL/H HETERO LABS AIVEEN (U) LOPINAVIR LOPINAVIR / 200MG HETERO LABS LTD. UNIT INDIA ORAL SOLID 1.0X120.0 7/1/2011
DP/2111 LTD LIMITED / RITONAVIR /50MG (V) .-S.N0.439, 440, 441& ORDINARY TABLET
RITONAVIR 458, APIIC, PHARMA SEZ, TABLETS CONTAIN
POLLEPALLY (VILLAGE), ER
JADCHERLA (MANDAL)
509301 INDIA. HETERO
LABS LTD-22-110 IDA
JEEDIMETLA HYDERABAD
500-055 ANDHRA
PRADESH
1112 NDA/MAL/H MYLAN KIMSY MEDS LOPINAVIR LOPINAVIR + 200MG + MYLAN LABORATORIES INDIA ORAL SOLID 1.0X120.0 7/1/2008
DP/2112 LABORATORIE LTD + RITONAVIR 50MG LTD--F-4,F-12 MALEGAON ORDINARY TABLET
S LIMITED RITONAVIR MIDC SINNAR NASHIK TABLETS CONTAIN
STATE
1113 NDA/MAL/H AXA VITACARE AXA-LEVO LEVOFLOXACI 500MG/10 AXA PARENTERAL LIMITED- INDIA PARENTERAL 1.0X100.0 7/1/2015
DP/2114 PARENTERALS LIMITED N 0ML PLOT NO.936,937&939, ORDINARY ML VIAL
LTD HEMIHYDRAT VILL. KISHANPUR, INFUSION
E JAMALPUR,ROORKEE VIALS/BOTTL
247667, DISTT. HARIDWAR ES
(UTTARAKHAND) INDIA.
1114 NDA/MAL/H MACLEODS NORVIK AMLOVAS- AMLODIPINE 10MG MACLEODS INDIA ORAL SOLID 1.0X1.0X1 7/1/2005
DP/2116 PHARMACEUT ENTERPRISES 10 BESILATE PHARMACEUTICALS LTD .- ORDINARY 0.0
ICALS LTD LIMITED PLOT 25-27 SURVEY NO. TABLETS TABLET
366 PREMEIRE BLISTER,1.
INDUSTRIAL ESTATE 0X10.0X10
KACHIGAN DAMAN .0 TABLET
396210 INDIA STRIP
1115 NDA/MAL/H AVENTIS SURGIPHARM RIFAFOURE RIFAMPICIN+I 150MG+75 AVENTIS PHARMA- SOUTH ORAL SOLID 1.0X4.0X2 7/1/2005
DP/2118 PHARMA (U) LIMITED E-275 SONIAZID+PY MG+400M AVENTIS PHARMA, 315 AFRICA ORDINARY 0.0
(PTY) LTD RAZINAMIDE G+275MG WALTLOO ROAD, FILM- TABLET
SOUTH +ETHAMBUT SILVERTON 0127 COATED BLISTER
AFRICA OL PRETORIA TABLETS
1116 NDA/MAL/H ALKEM ABACUS MEGAPIME CEFEPIME 1G ALKEM LABORATORIES INDIA PARENTERAL 1.0X1.0X1 7/1/2011
DP/2120 LABORATORIE PHARMA LTD.-VILLAGE THANA, ORDINARY .0 G VIAL
S LIMITED (AFRICA) BADDI, DISTT. DRY VIALS
LIMITED SOLAN,HIMACHAL
PRADESH 173205 INDIA.
SANCE LABORATORIES
NO.2, KOZHUVANAL,
PALA, KOTTAYAM
DISTRICT-686573,
KERALA, INDIA.
1117 NDA/MAL/H ELYS VELVET ELYMOL PARACETAM 120MG/5 ELYS CHEMICAL KENYA ORAL LIQUID 1.0X60.0 7/1/1997
DP/2122 CHEMICAL PHARMA OL ML INDUSTRIES LTD-ROAD 'B' ORDINARY ML
INDUSTRIES LIMITED OFF ENTERPRISE ROAD, SUSPENSION BOTTLE,1.
LTD INDUSTRIAL AREA S 0X100.0
NAIROBI ML
BOTTLE
1118 NDA/MAL/H VHB MEDI LLOYDS PLATFIRST CISPLATIN 1MG/ML VHB MEDI SCIENCES LTD- INDIA PARENTERAL 1.0X50.0 7/1/2014
DP/2123 SCIENCES LTD PHARMACY PLOT 20, 21, 22 & 49,50, ORDINARY ML VIAL
5, RUDRAPUR,
UTTARAKHAND - INDIA
1119 NDA/MAL/H ELYS VELVET ELYMOX AMOXYCILLIN 125MG/5 ELYS CHEMICAL KENYA ORAL LIQUID 1.0X100.0 7/1/1997
DP/2124 CHEMICAL PHARMA ML INDUSTRIES LTD-ROAD 'B' ORDINARY ML
INDUSTRIES LIMITED OFF ENTERPRISE ROAD, DRY BOTTLE
LTD INDUSTRIAL AREA SUSPENSION
NAIROBI S/SYRUPS/D
ROPS
1120 NDA/MAL/H CIPLA LTD QUALITY BECLATE BECLOMETAS 100MCG/D CIPLA LTD.- -PLOT NO INDIA NASAL 1.0X200.0 7/1/2009
DP/2125 CHEMICALS LTD - 100 ONE OSE L/139 TO L/146, VERNA SYSTEMIC METERED
HUMAN INDUSTRIAL ESTATE, METERED- DOSE
VERNA, SOUTH GOA DOSE CANNISTE
DISTRICT, 403722 GOA LIQUIDS R
1121 NDA/MAL/H HILTON HEALTHCARE TRANSAMI TRANEXAMIC 500MG/5 HILTON PHARMA (PVT) PAKISTAN PARENTERAL 1.0X10.0X 7/1/2005
DP/2128 PHARMA LTD. N ACID ML LTD-PLOT 13 SECTOR 15 ORDINARY 5.0 ML
(PVT) LTD INJECTION KORANGI INDUSTRIAL AMPOULES AMPOULE
500MG AREA KARACHI
1122 NDA/MAL/H DAR AL DAWA GAMA CLAVODAR AMOXICILLIN 500MG/12 DAR AL DAWA-NA'UR JORDAN ORAL SOLID 1.0X2.0X7 7/1/2011
DP/2129 DEVELOPMEN PHARMACEUTIC /CLAVULANIC 5MG PLANT AMMAN ORDINARY .0 TABLET
T AND ALS (U) LIMITED ACID TABLETS BLISTER
INVESTMENT
CO LTD
1123 NDA/MAL/H IPCA MEDVIN ZERODOL- ACECLOFENA 200MG IPCA LABORATORIES LTD- INDIA ORAL SOLID 1.0X3.0X1 7/1/2011
DP/2130 LABORATORIE PHARMA CR C PLOT NO. 255/1, ORDINARY 0.0
S LIMITED VILLAGE ATHAL, TABLETS TABLET
DADRA AND NAGAR
HAVELI, INDIA.
1124 NDA/MAL/H AUROBINDO GITTOES LOPINAVIR/ LOPINAVIR/ 200MG/ AUROBINDO PHARMA LTD- INDIA ORAL SOLID 1.0X120.0 7/1/2010
DP/2132 PHARMA LTD PHARMACEUTIC RITONAVIR RITONAVIR 50MG UNIT III-SURVEY ORDINARY TABLET
ALS LIMITED NO.313,BACHUPALLY TABLETS CONTAIN
VILLAGE,QUTHUBULLAPU ER
R MANDAL R.R
DISTRICT(A.P),INDIA
1125 NDA/MAL/H NOVO STAR ACTRAPID HUMAN 100 I.U/ML NOVO NORDISK PHARMA- DENMARK PARENTERAL 1.0X10.0 7/1/1997
DP/2133 NORDISK PHARMACEUTIC INSULIN NOVO ALLE ORDINARY S ML VIAL
ALS LTD C VIALS
1126 NDA/MAL/H CADILA KARURI CEFAMOR- CEFALEXIN 250MG LA-MED HEALTHCARE PVT INDIA ORAL SOLID 1.0X5.0X2 7/1/1997
DP/2134 PHARMACEUT PHARMACEUTIC 250 LTD-1389 TRASAD ROAD, ORDINARY 0.0
ICALS LIMITED ALS LTD. DHOLKA, AHMEDABAD, CAPSULES CAPSULE
GUJARAT INDIA BLISTER
1127 NDA/MAL/H VHB MEDI LLOYDS SOLITAX CEFTRIAXONE 1G VHB MEDI SCIENCES LTD- INDIA PARENTERAL 1.0X1.0 G 7/1/2010
DP/2135 SCIENCES LTD PHARMACY PLOT 20, 21, 22 & 49,50, ORDINARY VIAL
LIMITED 51. INTEGRATED DRY VIALS
5, RUDRAPUR,
UTTARAKHAND - INDIA
1128 NDA/MAL/H MEDICAL KARURI SEDIPROCT HYDROCORTI 5MG + MEDICAL UNION PHARMA EGYPT TOPICAL 1.0X6.0 7/1/2003
DP/2136 UNION PHARMACEUTIC SUPOSITOR SONE+ 5MG .CO-ABU-SULTAN ISMAILIA EXTERNAL SUPPOSIT
PHARMACEUT ALS LTD. Y CINCHOCAINE +10MG EGYPT SUPPOSITORI ORY STRIP
ICALS + +10MG ES
ESCULOSIDE+
FRAMYCETIN
1129 NDA/MAL/H CENTAUR GITTOES INFLAZONE MULTIINGRE N/A CENTAUR INDIA TOPICAL 1.0X30.0 7/1/2005
DP/2141 PHARMACEUT PHARMACEUTIC DIENT PHARMACEUTICALS PVT EXTERNAL G TUBE
ICALS ALS LIMITED LTD --PLANT II PLOT 39-41 OINTMENTS
PRIVATE TIVIM INDUSTRIAL ESTATE
GOA 403 526
1130 NDA/MAL/H EGYPTIAN WIDE EPICOTIL TENOXICAM 20MG EGYPTIAN EGYPT PARENTERAL 1.0X3.0 7/1/2014
DP/2144 INTERNATION SPECTRUM INTERNATIONAL ORDINARY VIAL
AL ENTERPRISES PHARMACEUTICAL VIALS CARTON
PHARMACEUT (U) LIMITED INDUSTRIES COMPANY- +
ICAL 10TH OF RAMADAN CITY 1*3*2ML
INDUSTRIES FIRST INDUSTRIAL AREA WFI
COMPANY AMPOULE
1131 NDA/MAL/H BAYER SURGIPHARM PRIMOLUT HYDROXYPRO 250MG BAYER PHARMA A.G- GERMANY PARENTERAL 1.0X1.0 7/1/1997
DP/2149 PHARMA AG (U) LIMITED DEPOT GESTERONE MULLERSTRASSE 178, ORDINARY ML
HEXANOATE 13353 BERLIN, GERMANY AMPOULES AMPOULE
1132 NDA/MAL/H USV PRIVATE ABACUS GLYCOMET METFORMIN 850MG FREDUN INDIA ORAL SOLID 1.0X10.0X 7/1/2000
DP/2151 LIMITED PHARMA 850 PHARMACEUTICALS ORDINARY 10.0
(AFRICA) LIMITED---14,15,16 TABLETS TABLET
LIMITED ZORABIAN INDUSTRIAL BLISTER
COMPLEX PALAGHAR
(EAST), DIST THANE 401
404 INDIA
1133 NDA/MAL/H ABACUS ABACUS GLYNASE GLIPIZIDE 5MG FREDUN INDIA ORAL SOLID 1.0X10.0X 7/1/2000
DP/2154 PHARMA PHARMA PHARMACEUTICALS ORDINARY 10.0
(AFRICA) (AFRICA) LIMITED---14,15,16 TABLETS TABLET
LIMITED LIMITED ZORABIAN INDUSTRIAL BLISTER
COMPLEX PALAGHAR
404 INDIA
1134 NDA/MAL/H NIRMA LIFE PHARMA NIRPID 10 SOYA OIL 10%W/V ACULIFE HEALTHCARE INDIA PARENTERAL 1.0X500.0 7/1/2011
DP/2156 LIMITED AFRICA LIMITED INTRAVEN PVT. LTD-VILLAGE ORDINARY ML
(HEALTHCARE OUS FAT SACHANA ,TALUKA - INFUSION BOTTLE
DI VISION) EMULSION VIRAMGAM , VIALS/BOTTL
NIRLIFE AHMEDABAD 382150 ES
HEALTHCARE GUJARAT
1135 NDA/MAL/H NIRMA LIFE PHARMA NIRPID INTRAVENOU 20%W/V ACULIFE HEALTHCARE INDIA PARENTERAL 1.0X500.0 7/1/2010
DP/2158 LIMITED AFRICA LIMITED S FAT PVT. LTD-VILLAGE ORDINARY ML
(HEALTHCARE EMULSION SACHANA ,TALUKA - INFUSION BOTTLE
DI VISION) VIRAMGAM , VIALS/BOTTL
HEALTHCARE GUJARAT
1136 NDA/MAL/H SANOFI LABOREX VAXIGRIP INFLUENZA 15MCG + SANOFI PASTEUR-1541 FRANCE PARENTERAL 1.0X0.5 7/1/2011
DP/2159 PASTEUR UGANDA VIRUS 15MCG + AVENUE MARCEL ORDINARY ML PRE-
LIMITED STRAINS 15MCG MERIEUX, 69280 MARCY, PRE-FILLED FILLED
H1N1 + H3N2 LETOILE SANOFI PASTEUR SYRINGES SYRINGE
+B S.A-2,AVENUE PONT (1 DOSE)
PASTEUR 69007 LYON-
FRANCE(BUSINESS
ADDRESS)
1137 NDA/MAL/H EMCURE HARLEYS ACEM-500 CLARITHROM 500MG EMCURE INDIA ORAL SOLID 1.0X10.0 7/1/2005
DP/2160 PHARMACEUT UGANDA YCIN PHARMACEUTICALS LTD- ORDINARY TABLET
ICALS LTD LIMITED LANE NO.3 PHASE II SIDCO TABLETS BLISTER
INDUSTRIAL COMPLEX
BARI BRAHMANA JAMMU
(J&K) 18113
1138 NDA/MAL/H REMEDICA GOODMAN CYCLOVAX ACICLOVIR 5%W/W REMEDICA LIMITED- CYPRUS TOPICAL 1.0X10.0 7/1/1997
DP/2161 LTD INTERNATIONAL CREAM LIMASSOL INDUSTRIAL EXTERNAL G TUBE
LTD ESTATE, AHAR CREAMS
1139 NDA/MAL/H ELYS VELVET ELYCORT HYDROCORTI 1%W/W ELYS CHEMICAL KENYA TOPICAL 1.0X15.0 7/1/1997
DP/2164 CHEMICAL PHARMA SONE INDUSTRIES LTD-ROAD 'B' EXTERNAL G TUBE
INDUSTRIES LIMITED OFF ENTERPRISE ROAD, OINTMENTS
LTD INDUSTRIAL AREA
NAIROBI
1140 NDA/MAL/H RENE RENE TRAMAREN TRAMADOL 50MG RENE INDUSTRIES LTD- UGANDA ORAL SOLID 1.0X10.0X 7/1/2014
DP/2165 INDUSTRIES INDUSTRIES HYDROCHLOR PLOT 680, KAMULI ROAD, ORDINARY 10.0
LTD LIMITED IDE KIREKA, P.O BOX 6034, CAPSULES CAPSULE
KAMPALA BLISTER
1141 NDA/MAL/H ARISTO NORVIK ALSARTAN- LOSARTAN + 50MG + ARISTO INDIA ORAL SOLID 1.0X4.0X7 7/1/2011
DP/2170 PHARMACEUT ENTERPRISES AM AMLODIPINE 5MG PHARMACEUTICALS PVT. ORDINARY .0 TABLET
ICALS PVT LTD LIMITED LIMITED-PLOT NO. 208, FILM- BLISTER
NEW INDUSTRIAL AREA COATED
NO. II, MANDIDEEP- TABLETS
MADHYA PRADESH,
INDIA.
1142 NDA/MAL/H GLENMARK STAR GLEVO-500 LEVOFLOXACI 500MG GLENMARK INDIA ORAL SOLID 1.0X5.0X5 7/1/2003
DP/2173 PHARMACEUT PHARMACEUTIC N PHARMACEUTICALS LTD- ORDINARY .0 TABLET
ICALS LTD ALS LTD PLOT NO E -37, 39 ,D TABLETS BLISTER
1143 NDA/MAL/H CIPLA LTD QUALITY PARAFIZZ PARACETAM 500MG CIPLA LTD .-PLOT NO. 9, INDIA ORAL SOLID 1.0X12.0X 7/1/2005
DP/2175 CHEMICALS LTD - OL 10 AND 15, INDORE ORDINARY 4.0
HUMAN SPECIAL ECONOMIC ZONE, SOLUBLE TABLET
PHASE –II, PITHAMPUR, TABLETS STRIP,1.0X
DISTRICT DHAR, PIN 4.0X4.0
CODE: 454775, MADHYA TABLET
PRADESH STRIP
1144 NDA/MAL/H INTAS NORVIK RISPITAS-2 RISPERIDONE 2MG INTAS PHARMACEUTICALS INDIA ORAL SOLID 1.0X5.0X1 7/1/2011
DP/2176 PHARMACUIT ENTERPRISES LIMITED(BIOPHARMA ORDINARY 0.0
ICALS LTD LIMITED DIVISION)-CAMP ROAD TABLETS TABLET
SELAQUI-248197, BLISTER
DEHRADUN
(UTTARAKHAND) INDIA
1145 NDA/MAL/H KOTRA ABACUS AXCEL CEFUROXIME 250MG KOTRA PHARMA (M) SDN. MALAYSIA ORAL SOLID 1.0X10.0 7/1/2008
DP/2178 PHARMA (M) PHARMA CEFUROXI AXETIL BHD-1 JALAN TTC 12, ORDINARY CAPSULE
SDN BHD (AFRICA) ME-250 CHENG INDUSTRIAL CAPSULES BLISTER
MALYSIA
1146 NDA/MAL/H KAMPALA KAMPALA KAM PEN V PHENOXYME 125MG/5 KAMPALA UGANDA ORAL LIQUID 1.0X60.0 7/1/1997
DP/2180 PHARMACEUT PHARMACEUTIC THYLPENICILL ML PHARMACEUTICAL ORDINARY ML
ICAL AL INDUSTRIES IN INDUSTRIES (1996) DRY BOTTLE,1.
INDUSTRIES 1996 LIMITED LIMITED - -STRETCHER SUSPENSION 0X100.0
(1996) LTD ROAD PLOT M444B S/SYRUPS/D ML
NTINDA KAMPALA ROPS BOTTLE
1147 NDA/MAL/H GLAXOSMITH UNITED ROTARIX LIVE NOT LESS GLAXOSMITHKLINE BELGIUM ORAL LIQUID 1.0X1.5 7/1/2013
DP/2185 KLINE LTD HEALTHCARE ATTENUATED THAN 10⁶ BOILOGICALS-S.A RUE DE ORDINARY ML TUBE
DISTRIBUTORS RIX4414 CCID₅₀ OF I'INSTITUT 89 B-1330 LIQUIDS (1
LTD STRAIN OF THE RIXENSART DOSE),1.0
HUMAN RIX4414 X50.0X1.5
ROTAVIRUS STRAIN ML TUBE
OF THE (1 DOSE)
G1P[8] TYPE
1148 NDA/MAL/H KOTRA ABACUS AXCEL DIPHENHYDR 7MG+67.5 KOTRA PHARMA-BHD MALAYSIA ORAL LIQUID 1.0X60.0 7/1/2008
DP/2186 PHARMA (M) PHARMA DIPHENHYD AMINE MG/5ML 1, JALAN TTC 12, CHENG ORDINARY ML
SDN BHD (AFRICA) RAMINE HYDROCHLOR INDUSTRIAL ESTATE, SYRUPS BOTTLE
LIMITED PAEDIATRIC IDE + 75250 MELAKA, MALAYSIA
SYRUP AMMONIUM
CHLORIDE
1149 NDA/MAL/H CADILA ABACUS VOMIZ ONDANSETR 4MG/2ML CADILA HEALTHCARE LTD-- INDIA PARENTERAL 1.0X5.0X2 7/1/2005
DP/2187 HEALTH CARE PHARMA ON -SARKHEJ-PLOT ORDINARY .0 ML
LIMITED (AFRICA) 417,419,420, SARKHEJ- AMPOULES AMPOULE
LIMITED BAVLA NH ,1.0X5.0X4
NO.8A,VILLAGE: MORAIYA .0 ML
TAL: SANAND DISTRICT AMPOULE
AHMEDABAD 382210
1150 NDA/MAL/H CIPLA LTD QUALITY PREDNISOL PREDNISOLO 5MG CIPLA LTD .-PLOT NO. S- INDIA ORAL SOLID 1.0X1000. 7/1/2010
DP/2188 CHEMICALS LTD - ONE NE 103 TO S-105, S-107 TO S- ORDINARY 0 TABLET
HUMAN 112, L-147 TO L-1147-1, TABLETS CONTAIN
VERNA ELECTRONIC CITY ER,1.0X10
GOA .0X10.0
TABLET
BLISTER
1151 NDA/MAL/H KOTRA ABACUS AXCEL BETAMETHAS 0.1%W/W KOTRA PHARMA (M) SDN. MALAYSIA TOPICAL 1.0X15.0 7/1/2008
DP/2189 PHARMA (M) PHARMA BETAMETH ONE BHD-1 JALAN TTC 12, EXTERNAL G
SDN BHD (AFRICA) ASONE CHENG INDUSTRIAL CREAMS TUBE,1.0X
LIMITED ESTATE, 75250 MELAKA 5.0 G
MALYSIA TUBE
1152 NDA/MAL/H LABORATORY HARLEYS KLOXY CLOXACILLIN 250MG LABORATORY & ALLIED KENYA ORAL SOLID 1.0X1000. 7/1/1997
DP/2191 AND ALLIED UGANDA LTD.---PLOT 209/10349 ORDINARY 0
LTD LIMITED OFF MOMBASA RD CAPSULES CAPSULE
NAIROBI CONTAIN
ER,1.0X10
.0X10.0
CAPSULE
BLISTER
1153 NDA/MAL/H CIPLA LTD.. QUALITY CIPLOX-500 CIPROFLOXAC 500MG CIPLA LIMITED.-PLOT NO. INDIA ORAL SOLID 1.0X10.0X 7/1/2007
DP/2193 CHEMICALS LTD - IN L-139, S-103 & M-62, ORDINARY 10.0
HUMAN VERNA INDUSTRIAL TABLETS TABLET
ESTATE, VERNA SALCETTE, BLISTER,1.
GOA, PIN 403722 0X100.0
TABLET
CONTAIN
ER
1154 NDA/MAL/H XEPA SOUL DELMAW EUDERM UREA 10%W/W XEPA-SOUL PATTINSON MALAYSIA TOPICAL 1.0X45.0 7/1/1997
DP/2195 PATTISON (M) ENTERPRISES CREAM (MALAYSIA) SDN BHD-1-5 EXTERNAL G TUBE
SDN BHD LIMITED CHENG INDUSTRIAL CREAMS
ESTATE, 75250
MALEKA, MALAYSIA
1155 NDA/MAL/H PFIZER LABOREX MYCOBUTI RIFABUTIN 150MG PHARMACIA AND UPJOHN ITALY ORAL SOLID 1.0X30.0 7/1/1998
DP/2196 LABORATORIE UGANDA N S.P.A ITALY-VIA ORDINARY CAPSULE
S LTD LIMITED COMMESCION MARINO CAPSULES BOTTLE
DEL TRONTO(ASCOLI
PICENE)ITALY
1156 NDA/MAL/H LABORATORY HARLEYS WHITFIELD' BENZOIC 6%W/W + LABORATORY & ALLIED KENYA TOPICAL 1.0X20.0 7/1/1997
DP/2197 &ALLIED LTD UGANDA S ACID + 3%W/W LTD-PLOT NO. 209/10349 EXTERNAL G TUBE
LIMITED OINTMENT SALICYLIC OFF MOMBASA ROAD, OINTMENTS
ACID NAIROBI
P.O. BOX 42875, NAIROBI,
KENYA.
1157 NDA/MAL/H TROGE ECHO TRO- CEFTRIAXONE 1G REYOUNG CHINA PARENTERAL 1.0X50.0 7/1/2014
DP/2198 MEDICAL PHARMACY (U) CEFTRIAX SODIUM PHARMACEUTICAL CO. ORDINARY VIAL
GMBH LIMITED LTD-NO. 6 ERLANGSHAN DRY VIALS CARTON
ROAD, YIYUAN,
SHANDONG 256100
1158 NDA/MAL/H MERCK (PTY) UNITED EUTHYROX LEVOTHYROXI 50MCG MERCK KGAA - - GERMANY ORAL SOLID 1.0X4.0X2 7/1/2013
DP/2199 LTD HEALTHCARE 50MCG NE SODIUM FRANKFRUTER STRASSE ORDINARY 5.0
0X1.0X30.
0 TABLET
BLISTER
1159 NDA/MAL/H SHAIGAN HEALTHCARE CLYCIN CLINDAMYCI 10MG/ML SHAIGAN PAKISTAN TOPICAL 1.0X30.0 7/1/2004
DP/2201 PHARMACEUT LTD. N PHARMACEUTICALS (PVT) EXTERNAL ML
ICALS LTD PHOSPHATE LTD-14TH KM, ADYALA LOTIONS BOTTLE
ROAD, RAWALPINDI-
PAKISTAN
1160 NDA/MAL/H GALENTIC NORVIK NETRA HYDROCORTI 1%W/W GALENTIC PHARMA PVT. INDIA TOPICAL 1.0X15.0 7/1/2005
DP/2206 PHARMA( ENTERPRISES CORT SONE LIMITED-R-673, TTC MIDC, EXTERNAL G TUBE
INDIA)PVT LIMITED ACETATE RUBALE, THANE CREAMS
LTD BELAPURNAVI MUMBAI
400 701
INDIA
1161 NDA/MAL/H KOTRA ABACUS AXCEL CEPHALEXIN 500MG KOTRA PHARMA (M) SDN. MALAYSIA ORAL SOLID 1.0X10.0X 7/1/2010
DP/2208 PHARMA SDN PHARMA CEPHALEXI MONOHYDRA BHD-1 JALAN TTC 12, ORDINARY 10.0
BDN (AFRICA) N TE CHENG INDUSTRIAL CAPSULES CAPSULE
LIMITED ESTATE, 75250 MELAKA BLISTER
MALYSIA
1162 NDA/MAL/H GALENTIC VITACARE BENZYL BENZYL 25%W/W GALENTIC PHARMA PVT. INDIA TOPICAL 1.0X200.0 7/1/2005
DP/2211 PHARMA LIMITED BENZOATE BENZOATE LIMITED-R-673, TTC MIDC, EXTERNAL ML
(PVT)LTD RUBALE, THANE EMULSIONS BOTTLE,1.
BELAPURNAVI MUMBAI 0X100.0
400 701 ML
INDIA BOTTLE,1.
0X1000.0
ML
BOTTLE
1163 NDA/MAL/H DENK BENLE CONSULT CIPRO- CIPROFLOXAC 500MG ALLPHARMED PHARBIL GERMANY ORAL SOLID 1.0X10.0 7/1/2005
DP/2212 PHARMA LIMITED DENK 500 IN ARZNEIMITTEL GMBH-12 ORDINARY TABLET
D377081 FILM- BLISTER
COATED
TABLETS
1164 NDA/MAL/H ROYAL ROYAL PHARMA GENTAMICI GENTAMICIN 40MG/ML REYOUNG CHINA PARENTERAL 1.0X100.0 7/1/1997
DP/2214 PHARMA 2011 LIMITED N SULPHATE PHARMACEUTICAL CO. ORDINARY X2.0 ML
2011 LIMITED INJECTION LIMITED-NO. 1 RUIYANG AMPOULES AMPOULE
ROAD YIYUAN COUNTY,
SHANDONG PROVINCE, P.
R. CHINA
1165 NDA/MAL/H GITTOES GITTOES METOCLOP METOCLOPRA 5MG/ML NINGBO DAHONGYING CHINA PARENTERAL 1.0X10.0X 7/1/2005
DP/2216 PHARMACEUT PHARMACEUTIC RAMIDE MIDE PHARMACEUTICAL CO.LTD- ORDINARY 10.0X2.0
ICALS LIMITED ALS LIMITED NO. 396 MINGZHU ROAD, AMPOULES ML
HI-TECH PARK, NINGBO AMPOULE
CITY ZHEJIANG PROVINCE,
CHINA
1166 NDA/MAL/H GITTOES GITTOES AMINOPHY AMINOPHYLLI 20MG NINGBO DAHONGYING CHINA PARENTERAL 1.0X50.0X 7/1/2005
DP/2217 PHARMACEUT PHARMACEUTIC LINE NE PHARMACEUTICAL CO.LTD- ORDINARY 10.0 ML
ICALS LIMITED ALS LIMITED NO. 396 MINGZHU ROAD, AMPOULES AMPOULE
HI-TECH PARK, NINGBO
CHINA
1167 NDA/MAL/H BAYER SURGIPHARM PRIMOLUT NORETHISTER 5MG BAYER WEIMAR GMBH & GERMANY ORAL SOLID 1.0X3.0X1 7/1/1997
DP/2219 PHARMA AG (U) LIMITED N ONE CO. KG- ORDINARY 0.0
DOBEREINERSTRASSE 20 D- TABLETS TABLET
99427 WEIMAR, BLISTER,1.
GERMANY 0X30.0
TABLET
CONTAIN
ER
1168 NDA/MAL/H CADILA ABACUS AMLODAC AMLODIPINE 5MG CADILA HEALTHCARE INDIA ORAL SOLID 10.0X10.0 7/1/2003
DP/2220 HEALTHCARE PHARMA 5 BESYLATE LIMITED--KUNDAIM ORDINARY TABLET
LTD (AFRICA) INDUSTRIAL ESTATE, PLOT TABLETS STRIP,1.0X
LIMITED NO. 203-213, 3.0X10.0
KUNDAIM,GOA-403 115, TABLET
INDIA BLISTER
1169 NDA/MAL/H VOGEN BUFFALO DURAMOX AMOXICILLIN 500MG VOGEN LABORATORIES CYPRUS ORAL SOLID 1.0X2.0X1 7/1/2007
DP/2224 LABORATORIE HEALTH CARE 500 LTD-70, M.HERACLEOUS ORDINARY 0.0
S LTD LTD STR. AYIOS ATHANASIOS CAPSULES CAPSULE
INDUSTRIAL AREA, BLISTER,1.
LIMASSOL, CYPRUS 0X10.0X10
.0
CAPSULE
BLISTER
1170 NDA/MAL/H WIN- SURGIPHARM HEPA-MERZ L-ORNITHINE- 3G/5G WIN-MEDICARE PRIVATE INDIA ORAL LIQUID 1.0X10.0X 7/1/2004
DP/2226 MEDICARE (U) LIMITED GRANULES L-ASPARTATE LIMITED-MEERUT- ORDINARY 5.0 G
PVT LTD MUZAFFARNAGAR ROAD, OTHER SACHET
MODIPURAM - 250110 POWDERS/G
UTTAR PRADESH RANULES
1171 NDA/MAL/H MEDIPHARM MEDIPHARM PIRITEX MULTI- MULTI- MEDIPHARM INDUSTRIES( UGANDA ORAL LIQUID 1.0X100.0 7/1/1997
DP/2231 SALES INDUSTRIES WITH INGREDIENT INGREDIEN EA) LTD-PLOT 65 KAKAJJO ORDINARY ML
LIMITED (E.A) LTD CODEINE T ROAD BWEYOGERERE SYRUPS BOTTLE
P.O.BOX
6218,KAMPALA,UGANDA
DP/2232 PHARMACEUT SPECTRUM T PHARMACEUTICAL ORDINARY 0.0
MANUFACTU (U) LIMITED COMPANY LTD-P.O BOX TABLETS BLISTER
RING CO. LTD 69 AMMAN 11591
JORDAN NUZHAT SAHAB
SECURITY HOUSING
1173 NDA/MAL/H ASTRAZENEC MACNAUGHTON PULMICORT BUDESONIDE 0.25MG/M ASTRA ZENECA SWEDEN SWEDEN LUNG 1.0X4.0X5 7/1/2011
DP/2233 A LIMITED NEBULISER L OPERATIONS LIQUID ADMINISTRA .0X2.0 ML
PRODUCTION - TION LIQUID VIAL
KVARNBERGAGATANLZ SE- FOR
151-85,SWEDEN INHALATION
1174 NDA/MAL/H WOCKHARDT ABACUS WOSULIN- INSULIN 100IU/ML WOCKHARDT- INDIA PARENTERAL 1.0X3.0 7/1/2006
DP/2235 LTD PHARMA N HUMAN(REC WOCKHARDT BIOTECH ORDINARY S ML
(AFRICA) OMBINANT PARK, H14/2, M.I.D.C, C VIALS VIAL,1.0X
LIMITED DNA ORIGIN) WALUJ, AURANGABAD 10.0 ML
431136 MAHARASHTRA VIAL
1175 NDA/MAL/H NOVARTIS SURGIPHARM TEGRETOL CARBAMAZEP 200MG NOVARTIS FARMA S.P.A.- ITALY ORAL SOLID 1.0X5.0X1 7/1/1997
DP/2236 PHARMA AG (U) LIMITED 200 INE VIA PROVINCIALE SCHITO ORDINARY 0.0
131, 80058 TORRE TABLETS TABLET
ANNUNZIATA, ITALY BLISTER
1176 NDA/MAL/H WOCKHARDT ABACUS WOSULIN- INSULIN 100I.U/ML WOCKHARDT LIMITED -- INDIA PARENTERAL 1.0X10.0 7/1/2006
DP/2237 LTD PHARMA 30/70 HUMAN(REC WOCKHARDT BIOTECH ORDINARY S ML
(AFRICA) OMBINANT PARK, H14/2, M.I.D.C, C VIALS VIAL,1.0X
LIMITED DNA ORIGIN) WALUJ, AURANGABAD 3.0 ML
INDIA
1177 NDA/MAL/H UNI MEDICO SHREEJI UMOCLOX AMPICILLIN + 125MG UNI MEDICOLABS.- 21-22 INDIA ORAL LIQUID 1.0X100.0 7/1/2015
DP/2238 LAB PHARMACEUTIC CLOXACILLIN +125MG PHARMACITY SELAQUI ORDINARY ML
ALS LIMITED DEHRADUN 248197 DRY BOTTLE
SUSPENSION
S/SYRUPS/D
ROPS
1178 NDA/MAL/H REMEDICA GOODMAN CYCLOVAX ACYCLOVIR 200MG REMEDICA LIMITED- CYPRUS ORAL SOLID 1.0X3.0X1 7/1/1997
DP/2242 LTD INTERNATIONAL 200 LIMASSOL INDUSTRIAL ORDINARY 0.0
LTD TABLETS ESTATE, AHAR TABLETS TABLET
BLISTER
1179 NDA/MAL/H AFRICURE ROYAL PHARMA SIMDOL PARACETAM 500MG AFRICURE INDIA ORAL SOLID 10.0X10.0 7/1/1997
DP/2243 PHARMACEUT 2011 LIMITED TABLETS OL PHARMACEUTICALS ORDINARY TABLET
ICALS (INDIA) (INDIA) PRIVATE LIMITED- TABLETS BLISTER,1.
PRIVATE PLOT 9-12,DEWAN & SONS 0X1000.0
LIMITED INDL. AREA, TABLET
INDIA. ER
1180 NDA/MAL/H RENE RENE X-PEL MEBENDAZOL 100MG RENE INDUSTRIES LIMITED- UGANDA ORAL SOLID 1.0X1000. 7/1/2008
DP/2245 INDUSTRIES INDUSTRIES E PLOT 680, KAMULI ROAD, ORDINARY 0 TABLET
LTD LIMITED KIREKA CHEWABLE CONTAIN
TABLETS ER
1181 NDA/MAL/H GALENTIC VITACARE TETRACYCLI TETRACYCLIN 1%W/W GALENTIC PHARMA PVT. INDIA OPHTHALMI 1.0X3.5 G 7/1/2004
DP/2248 PHARMA LIMITED NE E LIMITED-R-673, TTC MIDC, C TUBE,1.0X
(PVT)LTD OPHTHALM RUBALE, THANE, INDIA OINTMENTS 5.0 G
IC TUBE
1182 NDA/MAL/H WOCKHARDT ABACUS WOSULIN-R INSULIN 100ML WOCKHARDT LIMITED -- INDIA PARENTERAL 1.0X3.0 7/1/2006
DP/2249 LTD PHARMA WOCKHARDT BIOTECH ORDINARY S ML
(AFRICA) PARK, H14/2, M.I.D.C, C VIALS VIAL,1.0X
LIMITED WALUJ, AURANGABAD 10.0 ML
INDIA
1183 NDA/MAL/H GALENTIC VITACARE CANDIGEN CLOTRIMAZO 1%W/W GALENTIC PHARMA PVT. INDIA TOPICAL 1.0X20.0 7/1/2004
DP/2250 PHARMA LTD LIMITED LE LIMITED -R-673, TTC EXTERNAL G TUBE
MIDC, RUBALE, THANE CREAMS
BELAPUR NAVI MUMBAI
400 701
INDIA
1184 NDA/MAL/H JOHNSON&JO PHILLIPS VERMOX MEBENDAZOL 500MG SPECPHARM HOLDINGS- SOUTH ORAL SOLID 1.0X1.0 7/1/2000
DP/2252 HNSON PTY PHARMACEUTIC E 15TH ROAD HALFWAY AFRICA ORDINARY TABLET
LTD ALS (UGANDA) HOUSE JOHNSON & CHEWABLE BLISTER
LIMITED JOHNSON (PTY) LTD-241 TABLETS
MAIN ROAD, RETREAT,
7945, CAPE TOWN
1185 NDA/MAL/H GITTOES GITTOES INDOMETH INDOMETHAC 25MG NINGBO DAHONGYING CHINA ORAL SOLID 1.0X1000. 7/1/2005
DP/2253 PHARMACEUT PHARMACEUTIC ACIN IN PHARMACEUTICAL CO LTD- ORDINARY 0
ICALS LIMITED ALS LIMITED NO 396, MINGZHU ROAD CAPSULES CAPSULE
NINGBO CITY CHINA CONTAIN
ER,1.0X10
.0X10.0
CAPSULE
BLISTER
1186 NDA/MAL/H MACK SHURIK LTD BURN CUR ACRIFLAVINE/ N/A TORQUE INDIA TOPICAL 1.0X20.0 7/1/1998
DP/2254 BROWN CREAM THYMOL PHARMACEUTICALS LTD- EXTERNAL G TUBE
1187 NDA/MAL/H GLAXOSMITH UNITED AUGMENTI AMOXICILLIN 400 MG + SMITHKLINE BEECHAM UNITED ORAL LIQUID 1.0X1.0X7 7/1/2010
DP/2256 KLINE LTD HEALTHCARE N + 57 MG / 5 PHARMACEUTICALS,- KINGDOM ORDINARY 0.0 ML
DISTRIBUTORS 457MG/5M CLAVULANIC ML CLARENDON ROAD, DRY BOTTLE
LTD L ACID WORTHING, WEST SUSPENSION
SUSSEX, BN148QH S/SYRUPS/D
ROPS
1188 NDA/MAL/H MYLAN KIMSY MEDS TENOFOVIR TENOFOVIR 300MG/30 MYLAN LABORATORIES INDIA ORAL SOLID 1.0X100.0 7/1/2009
DP/2258 LABORATORIE LTD DISOPROXIL DISOPROXIL + 0MG/600 LTD--F-4,F-12 MALEGAON ORDINARY TABLET
S LIMITED + LAMIVUDINE MG MIDC SINNAR NASHIK TABLETS BOTTLE,1.
(OTL) LAMIVUDIN + EFAVIRENZ 422113 MAHARASHTRA 0X1.0X30.
E+ STATE 0 TABLET
EFAVIRENZ MYLAN LABORATORIES BOTTLE
13 MIDCWALUJ
INDUSTRIAL AREA
AURANGABAD 431136
MAHARASTRA GREEN
STONE LIMITED-PLOT NO.
1189 NDA/MAL/H CIPLA LTD QUALITY TENOFOVIR TENOFOVIR 300MG CIPLA LTD .-PLOT NO. S- INDIA ORAL SOLID 1.0X30.0 7/1/2010
DP/2262 CHEMICALS LTD - DISOPROXIL DISOPROXIL 103 TO S-105, S-107 TO S- ORDINARY TABLET
HUMAN FUMARATE FUMARATE 112, L-147 TO L-1147-1, TABLETS BOTTLE
VERNA ELECTRONIC CITY
GOA
1190 NDA/MAL/H OTSUKA REDDYS CELEMIN AMINO 10%W/V+1 OTSUKA INDIA PARENTERAL 1.0X500.0 7/1/2001
DP/2263 PHARMACEUT PHARMA 10 PLUS ACIDS/ELECT 0%W/V PHARMACEUTICAL INDIA ORDINARY ML
ICAL INDIA LIMITED ROLYTES PRIVATE LTD-VILLAGE – INFUSION BOTTLE
PRIVATE VASANA – BAGS
SANAND, AHMADABAD
1191 NDA/MAL/H HETERO AIVEEN (U) TENOFOVIR TENOFOVIR 300MG + HETERO LABS LTD (UNIT- INDIA ORAL SOLID 1.0X30.0 7/1/2010
DP/2265 DRUGS LTD LIMITED / DISOPROXIL 300MG V)-SY.NO.438,439,440 & ORDINARY TABLET
LAMUVIDIN FUMARATE + 458 APIIC FORMULATION TABLETS BOTTLE
E LAMIVUDINE SEZ, POLEPALLY (V),
JEDCHERLA (M)
MAHABOOBNAGAR
DISTRICT, ANDHRA
LABS LTD-22-110 IDA
500-055 ANDHRA
PRADESH
1192 NDA/MAL/H SK AGE ABACUS QUININE QUININE 300MG SKANT HEALTH CARE LTD - INDIA ORAL SOLID 1.0X1000. 7/1/2011
DP/2266 EXPORTS PHARMA SULPHATE SULPHATE 1802-1805 GIDC PHASE III ORDINARY 0 TABLET
(AFRICA) TABLETS BP VAPI GUJARAT TABLETS CONTAIN
LIMITED ER,1.0X10
.0X10.0
TABLET
BLISTER
1193 NDA/MAL/H MYLAN KIMSY MEDS TENOFOVIR
TENOFOVIR 300MG+30 MYLAN LABORATORIES INDIA ORAL SOLID 1.0X30.0 7/1/2007
DP/2267 LABORATORIE LTD DISOPROXIL
DISOPROXIL 0MG LTD--F-4,F-12 MALEGAON ORDINARY TABLET
S LIMITED FUMARATEFUMARATE + MIDC SINNAR NASHIK TABLETS BOTTLE
(OTL) + LAMIVUDINE 422113 MAHARASHTRA
LAMIVUDIN STATE
E MYLAN LABORATORIES
13 MIDCWALUJ
INDUSTRIAL AREA
AURANGABAD 431136
MAHARASTRA QUESTA
CARE LIMITED-PLOT NO
1194 NDA/MAL/H DAWA SUPER MEDIC DAWAMOX AMOXYCILLIN 125MG/5 DAWA PHARMACEUTICALS KENYA ORAL LIQUID 1.0X100.0 7/1/1997
DP/2269 LIMITED LTD TRIHYDRATE ML LIMITED-PLOT 7879, BABA ORDINARY ML
DOGO ROAD RUARAKA DRY BOTTLE
SUSPENSION
S/SYRUPS/D
ROPS
1195 NDA/MAL/H UNIQUE TATA UGANDA ZITHROCIN AZITHROMYCI 500MG J.B. CHEMICALS AND INDIA ORAL SOLID 1.0X1.0X3 7/1/2006
DP/2270 PHARMACEUT LIMITED 500 N PHARMACEUTICALS LTD .- ORDINARY .0 TABLET
ICAL 128/1, G.I.D.C. FILM- BLISTER
LABORATORIE INDUSTRIAL AREA, COATED
S ANKLESHWAR, GUJARAT TABLETS
393002 INDIA
1196 NDA/MAL/H EAGLEVET MEDVIN ARTEMETH ARTEMETHER 20MG + IPCA LABORATORIES LTD- INDIA ORAL SOLID 1.0X10.0X 7/1/2010
DP/2271 UGANDA PHARMA ER + 120MG PLOT NO. 255/1, ORDINARY 3.0X6.0
LIMITED LIMITED 20MG/LUM LUMEFANTRI VILLAGE ATHAL, TABLETS TABLET
EFANTRINE NE SILVASSA-396230, BLISTER,1.
120MG DADRA AND NAGAR 0X30.0X18
BLISTER,1.
0X30.0X24
.0 TABLET
BLISTER,1.
0X10.0X1.
0X6.0
1197 NDA/MAL/H AJANTA ABACUS CLARANTA - CLARITHROM 500MG AJANTA PHARMA LTD .-B- INDIA ORAL SOLID 1.0X10.0X 7/1/2005
DP/2272 PHARMA LTD PHARMA 500 YCIN 4//5/6, MIDC ORDINARY 2.0X10.0
(AFRICA) INDUSTRIALAREA, TABLETS TABLET
LIMITED PAITHAN-431 128, BLISTER
AURANGBAD
1198 NDA/MAL/H AVENTIS SURGIPHARM ORELOX CEFPODOXIM 100MG SANOFI WINTHROP FRANCE ORAL SOLID 1.0X1.0X1 7/1/2010
DP/2278 INTERCONTIN (U) LIMITED E PROXETIL INDUSTRIE-SANOFI ORDINARY 0.0
ENTAL WINTHROP INDUSTRIE TABLETS TABLET
56, RUE DE CHOISY AU BLISTER
BAC
60205 COMPIÈGNE
1199 NDA/MAL/H SURGE LAB JEET LUMFORT LORATADINE 10MG NABIQASIM INDUSTRIES PAKISTAN ORAL SOLID 1.0X10.0X 7/1/2007
DP/2281 (PVT) LIMITED PHARMACEUTIC (PVT) LIMITED-17/24, ORDINARY 10.0
ALS LIMITED KORANGI INDUSTRIAL TABLETS TABLET
AREA, KARACHI, PAKISTAN BLISTER
1200 NDA/MAL/H GITTOES GITTOES PROPAN PROPRANOLO 40MG AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1.0X10.0X 7/1/2011
DP/2282 PHARMACEUT PHARMACEUTIC L NO.33,SECTOR ORDINARY 10.0
E INDIA TABLET
CONTAIN
ER
1201 NDA/MAL/H SERUM NORVIK SII DIPTHERIA >25LF(>30I SERUM INSTITUTE OF INDIA PARENTERAL 1.0X10.0 7/1/1997
DP/2283 INSTITUTE OF ENTERPRISES DIPHTHERI TOXOID+TETA U)+>5LF(>4 INDIA LTD-212/2 ORDINARY ML VIAL
INDIA LTD. LIMITED A TETANUS NUS 0IU)+<16O HADAPSAR, PUNE, 411028, VIALS (20
PERTUSIS TOXOID+B.PE U(>4PU) INDIA DOSES),1.
RTUSIS ADSORBED 0X5.0 ML
ADSORBED ON VIAL (10
ON ≥1.5MG DOSES),1.
ALUMINIUM 0X0.5 ML
PHOSPATE AMPOULE
(1 DOSE)
1202 NDA/MAL/H SURGE LAB JEET LUMFORT LORATADINE 5MG/5ML NABIQASIM INDUSTRIES PAKISTAN ORAL LIQUID 1.0X60.0 7/1/2007
DP/2284 (PVT) LIMITED PHARMACEUTIC SYRUP (PVT) LIMITED-17/24, ORDINARY ML
ALS LIMITED KORANGI INDUSTRIAL SYRUPS BOTTLE
1203 NDA/MAL/H GLAXO UNITED ZINNAT CEFUROXIME 250MG GLAXOSMITHKLINE UK UNITED ORAL SOLID 1.0X10.0 7/1/1997
DP/2287 WELLCOME HEALTHCARE AXETIL LTD-HARMIRE RD KINGDOM ORDINARY TABLET
(KENYA) LTD DISTRIBUTORS BARNARD CASTLE FILM- BLISTER,1.
LTD DURHAM, DL12DT UNITED COATED 0X50.0
TABLETS TABLET
CARTON
1204 NDA/MAL/H GITTOES GITTOES CHLORAMP CHLORAMPH 250MG NINGBO DAHONGYING CHINA ORAL SOLID 10.0X10.0 7/1/2005
DP/2289 PHARMACEUT PHARMACEUTIC HENICOL ENICOL PHARMACEUTICAL CO.LTD- ORDINARY CAPSULE
ICALS LIMITED ALS LIMITED NO. 396 MINGZHU ROAD, CAPSULES BLISTER,1.
HI-TECH PARK, NINGBO 0X1000.0
CITY ZHEJIANG PROVINCE, CAPSULE
CHINA CONTAIN
ER
DP/2290 LABORATORIE LTD E+ + 300MG LTD--F-4,F-12 MALEGAON ORDINARY TABLET
S LIMITED ZIDOVUDIN ZIDOVUDINE MIDC SINNAR NASHIK FILM- BOTTLE
E 422113 MAHARASHTRA COATED
STATE TABLETS
MYLAN LABORATORIES
LTD --H-12 & H-13, MIDC,
WALUJ,AURANGABAD-
431136 MAHARASHTRA,
INDIA
1206 NDA/MAL/H HETERO AIVEEN (U) VALOVIR VALACYCLOVI 500MG HETERO LABS LTD (UNIT- INDIA ORAL SOLID 1.0X10.0X 7/1/2011
DP/2291 DRUGS LTD LIMITED R V)-SY.NO.438,439,440 & ORDINARY 10.0
SEZ, POLEPALLY (V), BLISTER
JEDCHERLA (M)
MAHABOOBNAGAR
DISTRICT, ANDHRA
LABS LTD-22-110 IDA
500-055 ANDHRA
PRADESH
1207 NDA/MAL/H MEDREICH SURGIPHARM FLEMING AMOXICILLIN 1000MG + NATCO PHARMA LTD- INDIA PARENTERAL 1.0X5.0X2 7/1/2007
DP/2292 PLC (U) LIMITED 1200 SODIUM + 200MG VIJAYAPUR, NORTH ORDINARY 0.0 ML
POTASSIUM NAGARIJUNA SAGA,INDIA DRY VIALS VIAL
CLAVULANAT
E
1208 NDA/MAL/H GLOBAL NAPI WIDE TIOCON TIOCONAZOL 1%W/W GLOBAL NAPI EGYPT TOPICAL 1.0X20.0 7/1/2005
DP/2293 PHARMACEUT SPECTRUM E PHARMACEUTICALS -2ND EXTERNAL G TUBE
ICALS ENTERPRISES INDUSTRIAL ZONE, NO.40, CREAMS
(U) LIMITED ST. NO 18, 6TH OCTOBER,
GIZA,
INVESTMENT STRIP
CO LTD
1210 NDA/MAL/H ERIS LTD BENLE CONSULT RANI-DENK RANITIDINE 150MG DENK PHARMA GMBH GERMANY ORAL SOLID 1.0X20.0 7/1/2000
DP/2296 LIMITED 150 &CO.KG- ORDINARY TABLET
PRINZREGENTESTR.79.816 TABLETS BLISTER,1.
75 MUENCHEN, 0X10.0
GERMANY, GOLLSTR, 1-D- TABLET
845529 BLISTER,1.
0X50.0
TABLET
CONTAIN
ER
1211 NDA/MAL/H DAWA SUPER MEDIC SABULIN SALBUTAMOL 2MG/5ML DAWA LIMITED -BABA KENYA ORAL LIQUID 1.0X1.0X1 7/1/2008
DP/2297 LIMITED LTD SYRUP SULPHATE DOGO RWARAKA ORDINARY 00.0 ML
SYRUPS BOTTLE
1212 NDA/MAL/H MSN METRO SAFELEVO LEVOFLOXACI 500MG MSN LABORATORIES LTD- INDIA ORAL SOLID 1.0X3.0X1 7/1/2013
DP/2298 LABORATORIE PHARMACEUTIC 500 N PLOT 42 ANRICH ORDINARY 0.0
S PRIVATE ALS LIMITED INDUSTRIAL ESTATE TABLETS TABLET
LIMITED BOLLARAM MEDAK BLISTER,1.
DISTRICT 502325 ANDHRA 0X1.0X10.
PRADESH 0 TABLET
BLISTER
INVESTMENT STRIP
CO LTD
1214 NDA/MAL/H MERCK UNITED ZIAK 5/6.25 BISOPROLOL 5 MG + MERCK KGAA- GERMANY ORAL SOLID 1.0X3.0X1 7/1/2014
DP/2303 PHARMACEUT HEALTHCARE + 6.25 MG FRANKFURTER STRASSE ORDINARY 0.0
ICAL DISTRIBUTORS HYDROCHLOR 250 64271 DARMSTADT FILM- TABLET
MANUFACTU LTD OTHIAZIDE GERMANY COATED BLISTER
RING (PYT) TABLETS
LTD
1215 NDA/MAL/H MERCK UNITED ZIAK BISOPROLOL 10 MG + MERCK KGAA- GERMANY ORAL SOLID 1.0X3.0X1 7/1/2014
DP/2304 PHARMACEUT HEALTHCARE 10/6.25 + 6.25 MG FRANKFURTER STRASSE ORDINARY 0.0
RING (PYT) TABLETS
LTD
1216 NDA/MAL/H MERCK UNITED ZIAK BISOPROLOL 2.5 MG + MERCK KGAA- GERMANY ORAL SOLID 1.0X3.0X1 7/1/2014
DP/2305 PHARMACEUT HEALTHCARE 2.5/6.25 + 6.25 MG FRANKFURTER STRASSE ORDINARY 0.0
RING (PYT) TABLETS
LTD
1217 NDA/MAL/H BAYER SURGIPHARM MICROLUT LEVONORGES 0.03MG BAYER PHARMA A.G- GERMANY ORAL SOLID 1.0X3.0X3 7/1/2010
DP/2306 PHARMA AG (U) LIMITED TREL MULLERSTRASSE 178, ORDINARY 5.0
13353 BERLIN, GERMANY TABLETS TABLET
BLISTER
1218 NDA/MAL/H REMEDICA GOODMAN CLAVOMID AMOXICILLIN 500 MG + REMEDICA LIMITED - CYPRUS ORAL SOLID 2.0X10.0 7/1/2006
DP/2312 LTD INTERNATIONAL 625 + 125 MG AHARNON STREET, ORDINARY TABLET
LTD CLAVULANIC LIMASSOL INDUSTRIAL FILM- BLISTER
ACID ESTATE. LIMASSOL, COATED
1219 NDA/MAL/H REMEDICA GOODMAN CLAVOMID AMOXICILLIN 250 MG + REMEDICA LIMITED - CYPRUS ORAL SOLID 2.0X10.0 7/1/2006
DP/2313 LTD INTERNATIONAL 375 + 125 MG AHARNON STREET, ORDINARY TABLET
LTD CLAVULANIC LIMASSOL INDUSTRIAL FILM- BLISTER
ACID ESTATE. LIMASSOL, COATED
1220 NDA/MAL/H MACLEODS NORVIK RABEMAC- RABEPRAZOL 20MG MACLEODS INDIA ORAL SOLID 1.0X3.0X1 7/1/2005
DP/2314 PHARMACEUT ENTERPRISES 20 E SODIUM PHARMACEUTICALS LTD - ORDINARY 0.0
ICALS LTD LIMITED PLOT NO. 25-27, SURVEY FILM- TABLET
NO. 366, PREMIER COATED STRIP
KACHIGAM DAMAN
(UT), INDIA.
1221 NDA/MAL/H MICRO LABS LABOREX GRAMOCEF- CEFIXIME 50MG/5ML MICRO LABS LIMITED, INDIA ORAL LIQUID 1.0X30.0 7/1/2006
DP/2315 LTD UGANDA O-50 BOMMASANDRA -PLOT ORDINARY ML
LIMITED NO. 121-124 4TH PHASE DRY BOTTLE,1.
K.I.A.D.B BOMMASANDRA SUSPENSION 0X100.0
INDUSTRIAL AREA ANEKAL S/SYRUPS/D ML
TALUK BANGALORE 560 ROPS BOTTLE
099
1222 NDA/MAL/H MICRO LABS PHILLIPS DIAPRIDE-4 GLIMEPIRIDE 4MG MICRO LABS LTD--NO 92, INDIA ORAL SOLID 1.0X3.0X1 7/1/2006
DP/2318 LTD PHARMACEUTIC SIPCOT, HOSUR-635 126,, ORDINARY 0.0
ALS (UGANDA) TAMIL NADU, INDIA TABLETS TABLET
LIMITED BLISTER
1223 NDA/MAL/H COSMOS LTD ASTRA PHARMA COSMOL PARACETAM 120MG/5 COSMOS LIMITED- KENYA ORAL LIQUID 1.0X100.0 7/1/1998
DP/2319 (U) LIMITED OL ML RANGWE ROAD, OFF ORDINARY ML
LUNGA ROAD - SUSPENSION BOTTLE,1.
INDUSTRIAL AREA NAROBI S 0X60.0 ML
BOTTLE
1224 NDA/MAL/H GITTOES GITTOES ERO-125 ERYTHROMYC 125MG/5 AGOG PHARMA LTD-PLOT INDIA ORAL LIQUID 1.0X100.0 7/1/2006
DP/2320 PHARMACEUT PHARMACEUTIC DRY SYRUP IN ESTOLATE ML NO. 33, SECTOR II, VASAI, ORDINARY ML
ICALS LIMITED ALS LIMITED TALUKA INDL. DRY BOTTLE
SUSPENSION
S/SYRUPS/D
ROPS
1225 NDA/MAL/H JOHNSON&JO PHILLIPS BENYLIN ORCIPRENALI 5MG/5ML+ JOHNSON&JOHNSON PTY SOUTH ORAL LIQUID 1.0X200.0 7/1/2001
DP/2321 HNSON PTY PHARMACEUTIC CHESTY NE+BROMHE 4MG/5ML LTD.-EDMS BPK241 MAIN AFRICA ORDINARY ML
LTD ALS (UGANDA) XINE ROAD /HOOFWEG LIQUIDS BOTTLE,1.
LIMITED 241,RETREAT 7945,SOUTH 0X100.0
AFRICA ML
BOTTLE
1226 NDA/MAL/H EGYPTIAN WIDE TREFLUCAN FLUCONAZOL 150MG EGYPTIAN EGYPT ORAL SOLID 1.0X2.0X1 7/1/2007
DP/2322 INTERNATION SPECTRUM E INTERNATIONAL ORDINARY .0
AL ENTERPRISES PHARMACEUTICAL CAPSULES CAPSULE
PHARMACEUT (U) LIMITED INDUSTRIES COMPANY- STRIP
COMPANY
1227 NDA/MAL/H SWISS SHREEJI SWISSCLOX AMPICILLIN + 250 MG + SWISS PARENTERALS LTD- INDIA PARENTERAL 1.0X7.5 7/1/2011
DP/2324 PARENTERALS PHARMACEUTIC A CLOXACILLIN 250 MG 809 KERALA IND ESTATE ORDINARY ML VIAL
LTD ALS LIMITED GIDC NEAR BAVLA DIST DRY VIALS
AHMEDABAD 382220
GUJARAT INDIA
1228 NDA/MAL/H EMCURE HARLEYS SYLATE-500 ETAMSYLATE 50MG EMCURE INDIA ORAL SOLID 1.0X3.0X6 7/1/2004
DP/2326 PHARMACEUT UGANDA PHARMACEUTICALS LTD- ORDINARY .0 TABLET
ICALS LTD LIMITED LANE NO.3 PHASE II SIDCO TABLETS STRIP
INDUSTRIAL COMPLEX
BARI BRAHMANA JAMMU
(J&K) 18113
1229 NDA/MAL/H AUROBINDO GITTOES ABACAVIR ABACAVIR 300MG AUROBINDO PHARMA LTD- INDIA ORAL SOLID 1.0X60.0 7/1/2007
DP/2327 PHARMA LTD PHARMACEUTIC SULPHATE SULPHATE UNIT III-SURVEY ORDINARY TABLET
R MANDAL R.R
DISTRICT(A.P),INDIA
1230 NDA/MAL/H SERUM NORVIK SII DIPTHERIA >25LF(>30I SERUM INSTITUTE OF INDIA PARENTERAL 1.0X10.0 7/1/1997
DP/2333 INSTITUTE OF ENTERPRISES DIPHTHERI TOXOID+TETA U)+>5LF(>4 INDIA LTD-212/2 ORDINARY ML VIAL
INDIA LTD. LIMITED A& NUS TOXOID 0IU) HADAPSAR, PUNE, 411028, AMPOULES (20
TETANUS ADSORBED ADSORBED INDIA DOSES),1.
VACCINE ON ON 0X5.0 ML
ADSORBED( ALUMINIUM ≥1.5MG VIAL (10
PEDIATRIC) PHOSPHATE DOSES),1.
0X0.5 ML
AMPOULE
(1 DOSE)
1231 NDA/MAL/H SERUM NORVIK SII MEASLES NLT 1000 SERUM INSTITUTE OF INDIA PARENTERAL 1.0X1.0 7/1/1997
DP/2334 INSTITUTE OF ENTERPRISES MEASLES VIRUS+MUM CCID50+NL INDIA LTD-212/2 ORDINARY DOSE VIAL
INDIA LTD. LIMITED MUMPS & PS T 5000 HADAPSAR, PUNE, 411028, DRY VIALS + 0.5ML
RUBELLA VIRUS+RUBEL CCID50 INDIA OF THE
LA VIRUS +NLT1000 DILUENT
CCID50
1232 NDA/MAL/H GITTOES GITTOES AGOBEN MEBENDAZOL 100MG AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 10.0X10.0 7/1/2001
DP/2335 PHARMACEUT PHARMACEUTIC TABLETS(T E NO.33,SECTOR ORDINARY TABLET
ICALS LIMITED ALS LIMITED HANE) II,VASAI,TALUKA INDL CO- CHEWABLE BLISTER,1.
OP ESTATE LTD,GAURAI TABLETS 0X500.0
E INDIA CONTAIN
ER,1.0X10
0.0
TABLET
CONTAIN
ER,1.0X25
0.0
1233 NDA/MAL/H AUROBINDO PHILLIPS AUROXETIL- CEFUROXIME 500MG AUROBINDO PHARMA INDIA ORAL SOLID 1.0X1.0X1 7/1/2007
DP/2337 M PHARMA PHARMACEUTIC 500 AXETIL LIMITED, FORMULATIONS ORDINARY 0.0
LIMITED ALS (UGANDA) UNIT-VI- R7-AUROBINDO FILM- TABLET
LIMITED PHARMA LIMITED, COATED BLISTER
FORMULATIONS UNIT-VI TABLETS
SY.NO.329/39 & 329/47
CHITKUL(V) PATANCHERU
MANDAL, SANGA REDDY
DISTTELANGANA502307
1234 NDA/MAL/H GLAXOSMITH UNITED CLAVULIN AMOXICILLIN 200 MG + SMITHKLINE BEECHAM UNITED ORAL LIQUID 1.0X100.0 7/1/2003
DP/2338 KLINE HEALTHCARE + 28.5 MG PHARMACEUTICALS,- KINGDOM ORDINARY ML
PHARMACEUT DISTRIBUTORS CLAVULANIC CLARENDON ROAD, DRY BOTTLE,1.
ICAL KENYA LTD ACID WORTHING, WEST SUSPENSION 0X70.0 ML
LTD SUSSEX, BN148QH S/SYRUPS/D BOTTLE
ROPS
1235 NDA/MAL/H AUROBINDO PHILLIPS KOACT-375 AMOXICILLIN 250 MG + AUROBINDO PHARMA INDIA ORAL SOLID 1.0X4.0X5 7/1/2007
DP/2339 PHARMA LTD PHARMACEUTIC + 125 MG LTD, UNIT XII,.-SURVEY NO ORDINARY .0 TABLET
ALS (UGANDA) CLAVULANAT 314, BACHUPALLY TABLETS BLISTER,1.
LIMITED E POTASSIUM VILLAGE, 0X20.0X5.
QUTHUBULLAPAR, R.R 0 TABLET
DISTRICT .A. PRADESH BLISTER
1236 NDA/MAL/H AUROBINDO PHILLIPS KOACT-625 AMOXICILLIN 500 MG + AUROBINDO PHARMA INDIA ORAL SOLID 1.0X3.0X5 7/1/2007
DP/2342 PHARMA LTD PHARMACEUTIC + 125 MG LTD, UNIT XII,.-SURVEY NO ORDINARY .0 TABLET
ALS (UGANDA) CLAVULANAT 314, BACHUPALLY TABLETS BLISTER
LIMITED E POTASSIUM VILLAGE,
QUTHUBULLAPAR, R.R
DISTRICT .A. PRADESH
1237 NDA/MAL/H AUROBINDO GITTOES ABACAVIR ABACAVIR 20MG/ML AUROBINDO PHARMA INDIA ORAL LIQUID 1.0X240.0 7/1/2008
DP/2346 M PHARMA PHARMACEUTIC SULFATE SULPHATE LTD, UNIT III -SURVEY NO. ORDINARY ML
LIMITED ALS LIMITED ORAL 313, 314 BACHUPALLY LIQUIDS BOTTLE
SOLUTION (VILLAGE)
QUTHUBULLAPUR
(MANDAL) RR DISTRICT
HYDERABAD ANDHRA
PRADESH 500090
1238 NDA/MAL/H SERUM NORVIK HEPATITIS HEPATITIS B 20MCG/ML SERUM INSTITUTE OF INDIA PARENTERAL 1.0X10.0X 7/1/2005
DP/2348 INSTITUTE OF ENTERPRISES B VACCINE(RDN INDIA LTD-212/2 ORDINARY I 10.0 ML
INDIA LTD. LIMITED VACCINE(R A) ADULT HADAPSAR, PUNE, 411028, M VIALS VIAL (10
DNA) INDIA DOSE
ADULT VIAL),1.0X
50.0X1.0
ML VIAL
(1 DOSE
VIAL)
1239 NDA/MAL/H ASTRA MACNAUGHTON PULMICORT BUDESONIDE 200MCG ASTRAZENECA AB,- SWEDEN LUNG 1.0X100.0 7/1/2001
DP/2350 ZENECA AB LIMITED TURBUHAL GARTUNA & SNACKVIKEN ADMINISTRA DOSE
ER STOCKHOLM TION CANNISTE
METERED- R
DOSE
INHALER
1240 NDA/MAL/H REGAL REGAL PHARMA COLDCAP PARACETAM 500MG+30 REGAL KENYA ORAL SOLID 1.0X1.0X1 7/1/2007
DP/2352 PHARMACEUT (U) LTD DAY TIME OL/PSEUDOE MG+30MG PHARMACEUTICALS ORDINARY 2.0
ICALS LTD PHEDRINE LIMITED -PLOT 7879/18 CAPSULES CAPSULE
HCL/CAFFEIN OF BABA DOGO ROAD, BLISTER
E RUARAKA, NAIROBI
1241 NDA/MAL/H ASTRA MACNAUGHTON NEXIUM ESOMEPRAZO 10MG ASTRA ZENECA AB-SE-151 SWEDEN ORAL SOLID 1.0X28.0 7/1/2013
DP/2353 ZENECA LIMITED LE (AS 85 SODERTALJE, SWEDEN ORDINARY SACHET
MAGNESIUM (GARTUNAVAGEN & GRANULES CARTON
TRIHYDRATE) SNACKVIKEN)
1242 NDA/MAL/H GITTOES GITTOES QUININE QUININE 600MG/2 NINGBO DAHONGYING CHINA PARENTERAL 1.0X10.0X 7/1/2005
DP/2356 PHARMACEUT PHARMACEUTIC DIHYDROCHL ML PHARMACEUTICAL CO.LTD- ORDINARY 2.0 ML
ICALS LIMITED ALS LIMITED ORIDE NO. 396 MINGZHU ROAD, AMPOULES AMPOULE
CHINA
1243 NDA/MAL/H REMEDICA GOODMAN ASPIREM ASPIRIN 75MG REMEDICA LIMITED- CYPRUS ORAL SOLID 1.0X2.0X2 7/1/2007
BLISTER
1244 NDA/MAL/H REMEDICA GOODMAN CLAREM CLARITHROM 500MG REMEDICA LTD-AHARNON CYPRUS ORAL SOLID 1.0X2.0X7 7/1/2007
DP/2361 LTD INTERNATIONAL 500 YCIN STREET, LIMASSOL ORDINARY .0 TABLET
LTD INDUSTRIAL ESTATE, 3056 FILM- BLISTER
LIMASSOL COATED
TABLETS
1245 NDA/MAL/H GALENTIC VITACARE CANDISTATI NYSTATIN 100,000I.U GALENTIC PHARMA PVT. INDIA TOPICAL 1.0X30.0 7/1/2009
DP/2362 PHARMA LTD LIMITED N LIMITED -R-673, TTC EXTERNAL G TUBE
OINTMENT MIDC, RUBALE, THANE OINTMENTS
BELAPUR NAVI MUMBAI
400 701
INDIA
1246 NDA/MAL/H GITTOES GITTOES GENTAMICI GENTAMICIN 80MG/2ML NINGBO DAHONGYING CHINA PARENTERAL 1.0X100.0 7/1/2005
DP/2363 PHARMACEUT PHARMACEUTIC N SULPHATE PHARMACEUTICAL CO.LTD- ORDINARY X2.0 ML
ICALS LIMITED ALS LIMITED SULPHATE NO. 396 MINGZHU ROAD, AMPOULES AMPOULE
CHINA
1247 NDA/MAL/H MEDICO MAISHA VOXEL-500 LEVOFLOXACI 500MG MEDICO REMEDIES PVT INDIA ORAL SOLID 1.0X10.0 7/1/2015
DP/2364 REMEDIES MEDICAL N LIMITED-8 & 9 DEWAN & ORDINARY TABLET
PVT LTD SUPPLIES SONS, UDYOG NAGAR FILM- BLISTER
LIMITED PALGAR, DISTRICT THANE COATED
MAHARASHTRA, INDIA TABLETS
1248 NDA/MAL/H UNIQUE TATA UGANDA IFICIPRO CIPROFLOXAC 200MG/10 UNIQUE INDIA PARENTERAL 1.0X100.0 7/1/2005
DP/2366 PHARMACEUT LIMITED INJECTION IN 0ML PHARMACEUTICALS LABS ( ORDINARY ML
ICALS LTD A DIV OF J.B CHEMICALS & INFUSION BOTTLE
PHARMACEUTICAL LTD)-- VIALS/BOTTL
304-308 ,GIDC , PANOLI ES
394116
1249 NDA/MAL/H REMEDICA GOODMAN FELEXIN CEPHALEXIN 125MG/5 REMEDICA LIMITED - CYPRUS ORAL LIQUID 1.0X100.0 7/1/2007
DP/2367 LTD INTERNATIONAL 125 MONOHYDRA ML AHARNON STREET, ORDINARY ML
LTD TE LIMASSOL INDUSTRIAL DRY BOTTLE
ESTATE. LIMASSOL, SUSPENSION
CYPRUS 3056, CYPRUS S/SYRUPS/D
ROPS
1250 NDA/MAL/H REGAL REGAL PHARMA DERMIDEX MICONAZOLE 2%W/W REGAL KENYA TOPICAL 1.0X15.0 7/1/2007
DP/2368 PHARMACEUT (U) LTD CREAM NITRATE PHARMACEUTICALS LTD- EXTERNAL G TUBE
ICALS LTD BABA DOGO ROAD, CREAMS
RAURAKA,NAIROBI,KENYA
1251 NDA/MAL/H ARISTO NORVIK TRANLOK TRANEXAMIC 500MG/5 ARISTO INDIA PARENTERAL 1.0X5.0X5 7/1/2010
DP/2369 PHARMACEUT ENTERPRISES 500MG ACID ML PHARMACEUTICALS PVT. ORDINARY .0 ML
ICALS LIMITED INJECTION LIMITED-PLOT NO. 208, AMPOULES AMPOULE
NEW INDUSTRIAL AREA
NO.II,MANDIDEEEP
PRADESH
1252 NDA/MAL/H PHARMA OMAB UGANDA TOPIZONE FUSIDIC ACID 20MG/G+1 PHARMA INTERNATIONAL JORDAN TOPICAL 1.0X15.0 7/1/2007
DP/2371 INTERNATION LIMITED CREAM + MG/G COMPANY-MAIN STREET, EXTERNAL G TUBE
AL COMPANY BETAMETHAS AL QASTAL INDUSTRIAL CREAMS
ONE AREA AMMAN- JORDAN
VALERATE JORDAN
1253 NDA/MAL/H INDOCO STAR CLOBEN CLOTRIMAZO 1%W/W/ INDOCO REMEDIES INDIA TOPICAL 1.0X15.0 7/1/2007
DP/2373 REMEDIES PHARMACEUTIC SKIN LE/ 0.025%W/ LIMITED-L-14 VERNA EXTERNAL G TUBE
LTD ALS LTD CREAM BECLOMETAS W INDUSTRIAL AREA VERNA CREAMS
ONE
1254 NDA/MAL/H COSMOS LTD ASTRA PHARMA PYRAZINA PYRAZINAMI 500MG COSMOS LIMITED-- KENYA ORAL SOLID 1.0X1000. 7/1/1997
DP/2374 (U) LIMITED MIDE DE RANGWA ROAD, OFF ORDINARY 0 TABLET
TABLETS LUNGA LUNGA ROAD,P.O TABLETS CONTAIN
INDUSTRIAL AREA .0X10.0
TABLET
STRIP
1255 NDA/MAL/H GLAXO UNITED CLAVULIN AMOXICILLIN 875 MG + SMITHKLINE BEECHAM UNITED ORAL SOLID 1.0X2.0X1 7/1/2010
DP/2375 SMITHLINE HEALTHCARE 1G + 125 MG PHARMACEUTICALS,- KINGDOM ORDINARY .0X7.0
LIMITED DISTRIBUTORS CLAVULANIC CLARENDON ROAD, FILM- TABLET
LTD ACID WORTHING, WEST COATED BLISTER
SUSSEX, BN148QH TABLETS
1256 NDA/MAL/H INDOCO STAR METCHEK- METFORMIN 500MG INDOCO REMEDIES LTD-B- INDIA ORAL SOLID 1.0X10.0X 7/1/2007
DP/2376 REMEDIES PHARMACEUTIC 500 20, MIDC, WALUJ, ORDINARY 10.0
LTD ALS LTD AURANGABAB 431136 TABLETS TABLET
INDIA BLISTER
1257 NDA/MAL/H CADILA ABACUS R-LOC RANITIDINE 150MG CADILA HEALTH CARE LTD- INDIA ORAL SOLID 1.0X10.0X 7/1/1998
DP/2377 HEALTH CARE PHARMA TABLETS KUNDAIM INDUSTRIAL ORDINARY 10.0
LIMITED (AFRICA) ESTATE, PLOT NO. 203- TABLETS TABLET
LIMITED 213, KUNDAIM,GOA-403 BLISTER
115, INDIA
1258 NDA/MAL/H GLAXOSMITH UNITED AUGMENTI AMOXICILLIN 1000 MG + SMITHKLINE BEECHAM UNITED PARENTERAL 1.0X10.0X 7/1/1997
DP/2378 KLINE HEALTHCARE N + 200 MG PHARMACEUTICALS,- KINGDOM ORDINARY 1.2 G VIAL
PHARMACEUT DISTRIBUTORS CLAVULANIC CLARENDON ROAD, DRY VIALS
ICAL KENYA LTD ACID WORTHING, WEST
LTD SUSSEX, BN148QH
1259 NDA/MAL/H PT SANBE MEDVIN PUMPITOR OMEPRAZOLE 40MG PT SANBE FARMA JI INDONESIA PARENTERAL 1.0X1.0 7/1/2014
DP/2379 FARMA PHARMA INDUSTRI-NO.8 KOMPLEKS ORDINARY VIAL
LIMITED INDUSTRI CIMAREME VIALS CARTON
PADALARANG BANDUNG +1
AMPOULE
OF
SOLVENT
1260 NDA/MAL/H AFRICURE ROYAL PHARMA SIMTRIM- CO- 480MG AFRICURE INDIA ORAL SOLID 1.0X10.0X 7/1/1997
DP/2381 PHARMACEUT 2011 LIMITED 480 TRIMOXAZOL PHARMACEUTICALS ORDINARY 10.0
ICALS (INDIA) TABLETS E (INDIA) PRIVATE LIMITED- TABLETS TABLET
PRIVATE PLOT 9-12,DEWAN & SONS BLISTER,1.
LIMITED INDL. AREA, 0X1000.0
VEOOR,PALGHAR-401404. TABLET
INDIA. CONTAIN
ER
1261 NDA/MAL/H GLAXOSMITH UNITED AUGMENTI AMOXICILLIN 500 MG + SMITHKLINE BEECHAM UNITED PARENTERAL 1.0X10.0X 7/1/1997
DP/2383 KLINE HEALTHCARE N + 100 MG PHARMACEUTICALS,- KINGDOM ORDINARY 25.0 ML
PHARMACEUT DISTRIBUTORS CLAVULANIC CLARENDON ROAD, DRY VIALS VIAL
LTD SUSSEX, BN148QH
1262 NDA/MAL/H PHARMA OMAB UGANDA CLARIX 500 CLARITHROM 500MG PHARMA INTERNATIONAL JORDAN ORAL SOLID 1.0X2.0X7 7/1/2007
DP/2384 INTERNATION LIMITED YCIN COMPANY-MAIN STREET, ORDINARY .0 TABLET
AL CO AL QASTAL INDUSTRIAL FILM- BLISTER
JORDAN TABLETS
1263 NDA/MAL/H COSMOS ASTRA PHARMA COZEPAM DIAZEPAM 5MG COSMOS LIMITED-- KENYA ORAL SOLID 1.0X10.0X 7/1/2000
DP/2385 LIMITED (U) LIMITED 5MG RANGWA ROAD, OFF ORDINARY 10.0
LUNGA LUNGA ROAD,P.O TABLETS TABLET
BOX 414 33, NAIORBI BLISTER,1.
INDUSTRIAL AREA 0X1000.0
TABLET
CONTAIN
ER
1264 NDA/MAL/H HILTON HEALTHCARE NEOGAB GABAPENTIN 100MG HILTON PHARMA (PVT) PAKISTAN ORAL SOLID 1.0X10.0 7/1/2005
DP/2386 PHARMA LTD. LTD-PLOT 13 SECTOR 15 ORDINARY CAPSULE
(PVT) LTD KORANGI INDUSTRIAL CAPSULES BLISTER
AREA KARACHI
1265 NDA/MAL/H DAWA SUPER MEDIC VERMOUT MEBENDAZOL 100MG/5 DAWA LIMITED -BABA KENYA ORAL LIQUID 1.0X30.0 7/1/2010
DP/2387 LIMITED LTD E ML DOGO RWARAKA ORDINARY ML
SUSPENSION BOTTLE
S
1266 NDA/MAL/H MERCK PHILLIPS STOCRIN EFAVIRENZ 600MG ZHEJIANG HUAHAI CHINA ORAL SOLID 1.0X30.0 7/1/2004
DP/2394 SHARP & PHARMACEUTIC PHARMACEUTICAL CO. ORDINARY TABLET
DOHME BV ALS (UGANDA) LTD-XUNQIAO, LINHAI, TABLETS BOTTLE
LIMITED ZHEJIANG PROVINCE
317024 PEOPLES’
REPUBLIC OF CHINA
MERCK SHARP & DOHME
B.V-WAARDENWEG
392031 BN, HAARLEM
1267 NDA/MAL/H A.MENARINI STAR FASTUM KETOPROFEN 2.5%W/W A. MENARINI ITALY TOPICAL 1.0X20.0 7/1/2005
DP/2395 INDUSTRIE PHARMACEUTIC GEL MANUFACTURING EXTERNAL G
FARMACEUTI ALS LTD LOGISTICS AND SERVICES GELS AND TUBE,1.0X
CHE S.R.I S.R.L-VIA SETTE SANTI 3, SOLS 30.0 G
50131 FIRENZE-ITALY TUBE,1.0X
50.0 G
TUBE,1.0X
100.0 G
TUBE
1268 NDA/MAL/H SUN STAR VOLINI MULTI MULTI SUN PHARMACEUTICALS INDIA TOPICAL 1.0X1.0X3 7/1/2005
DP/2399 PHARMACEUT PHARMACEUTIC INGREDIENT INGREDIEN INDUSTRIES LIMITED- EXTERNAL 0.0 G
ICAL ALS LTD T INDUSTRIAL AREA 3, A.B OTHER TUBE
INDUSTRIES ROAD, MADHYA, INDIA GELS/SOLS
LIMITED
1269 NDA/MAL/H PHARMA OMAB UGANDA TOPIDIC 2% FUSIDIC ACID 20MG/G PHARMA INTERNATIONAL JORDAN TOPICAL 1.0X15.0 7/1/2007
DP/2400 INTERNATION LIMITED COMPANY-MAIN STREET, EXTERNAL G TUBE
AL COMPANY AL QASTAL INDUSTRIAL CREAMS
AREA AMMAN- JORDAN
JORDAN
1270 NDA/MAL/H MEGA ABACUS ENAT NATURAL 400IU MEGA LIFE SCIENCES THAILAND ORAL SOLID 1.0X3.0X1 7/1/2005
DP/2401 LIFESCIENCES PHARMA VITAMIN E PUBLIC COMPANY ORDINARY 0.0
(AUSTRALIA) (AFRICA) LIMITED-384 SOIB CAPSULES CAPSULE
PTY LTD LIMITED PATTANA 3 RD BANGPOO BLISTER
INDUSTRIAL ESTATE
SAMUTPRAKARN 10280
1271 NDA/MAL/H UNICHEM EUROPA LOSAR 50 LOSARTAN 50MG UNICHEM LABORATORIES INDIA ORAL SOLID 1.0X10.0X 7/1/2005
DP/2404 LABORATORIE HEALTHCARE POTASSIUM LTD---VILLAGE BHATAULI ORDINARY 10.0
S LIMITED√ (U) LTD KALA, BADDI HIMACHAL FILM- TABLET
PRADESH, INDIA COATED BLISTER
TABLETS
1272 NDA/MAL/H RENE RENE RENIRON MULTI- MULTI- RENE INDUSTRIES LIMITED- UGANDA ORAL LIQUID 1.0X100.0 7/1/2001
DP/2408 INDUSTRIES INDUSTRIES TONIC INGREDIENT INGREDIEN PLOT 680, KAMULI ROAD, ORDINARY ML
LIMITED LIMITED T KIREKA SYRUPS BOTTLE,1.
0X200.0
ML
BOTTLE,1.
0X60.0 ML
BOTTLE
1273 NDA/MAL/H TORRENT KARURI DEPLATT CLOPIDOGREL 75MG TORRENT INDIA ORAL SOLID 1.0X3.0X1 7/1/2004
DP/2409 PHARMACEUT PHARMACEUTIC PHARMACEUTICALS LTD- ORDINARY 0.0
ICALS LTD ALS LTD. INDRAD-382721, TAL KADI, TABLETS TABLET
AHMEDABAD, INDIA BLISTER
1274 NDA/MAL/H RENE RENE DOXYREN DOXYCYCLINE 100MG RENE INDUSTRIES LIMITED- UGANDA ORAL SOLID 1.0X10.0X 7/1/2007
LTD LIMITED KIREKA CAPSULES CAPSULE
BLISTER
1275 NDA/MAL/H STEDMAN VEERAM DREZ POVIDONE 5%W/W + STEDMAN INDIA TOPICAL 1.0X30.0 7/1/2010
DP/2411 PHARMACEUT HEALTHCARE IODINE + 1%W/W PHARMACEUTICALS PVT EXTERNAL G
ICALS PVT. (U) LIMITED METRONIDAZ LIMITED-NO. C-4, SIDCO OINTMENTS TUBE,1.0X
LTD OLE PHARMACEUTICAL 10.0 G
COMPLEX, ALATHUR, TUBE,1.0X
THIRUPORUR, 100.0 G
KANCHEEPURAM DIST 603 TUBE,1.0X
110, TAMILNADU, INDIA 250.0 G
TUBE
1276 NDA/MAL/H SPARSH BIO- ABACUS SPAMCIL AMPICILLIN 125MG/5 SPARSH BIO-TECH LTD- INDIA ORAL LIQUID 1.0X100.0 7/1/1998
DP/2414 TECH PVT LTD PHARMA ML PLOT NO.1 SURVEY ORDINARY ML
(AFRICA) NO.242/234/244, VILLAGE DRY BOTTLE
LIMITED LAKHABARAD, JAMNAGAR- SUSPENSION
361006 S/SYRUPS/D
ROPS
1277 NDA/MAL/H CENTAUR GITTOES SOLINA DIAZEPAM 5MG CENTAUR INDIA ORAL SOLID 1.0X1000. 7/1/1997
DP/2415 PHARMACEUT PHARMACEUTIC TABLETS PHARMACEUTICALS LTD- ORDINARY 0 TABLET
ICALS LTD ALS LIMITED PLOT NO.3 TIVIN TABLETS CONTAIN
INDUSTRIAL ESTATE ER,1.0X10
KARASWADA 403526 .0X10.0
INDIA TABLET
BLISTER,1.
0X100.0X1
0.0
TABLET
BLISTER
1278 NDA/MAL/H INDOCO TATA UGANDA LIDOCAINE LIDOCAINE 2% W/V INDOCO REMEDIES LTD-L- INDIA PARENTERAL 1.0X20.0 7/1/2006
DP/2420 REMEDIES LIMITED INJ.BP 32,33 AND VERNA ORDINARY ML VIAL
LTD INDUSTRIAL ESTATE OTHER VIALS
VERNA – SALCATTE GOA,
403722 INDIA
1279 NDA/MAL/H INDOCO STAR TAMIGEN GENTAMICIN 0.3%W/V INDOCO REMEDIES LTD---L- INDIA OPHTHALMI 1.0X5.0 7/1/2006
DP/2421 REMEDIES PHARMACEUTIC EYE/EAR SULPHATE 32, 33 & 34, VERNA IND. C DROPS ML
LIMITED ALS LTD DROPS AREA, VERNA GOA-403722 BOTTLE,1.
0X10.0 ML
BOTTLE
1280 NDA/MAL/H INDOCO STAR TAMIGEN-S GENTAMICIN 0.3%W/V+ INDOCO REMEDIES LTD---L- INDIA OTHER 1.0X5.0 7/1/2006
DP/2422 REMEDIES PHARMACEUTIC EYE/EAR SULPHATE+D 0.1%W/V 32, 33 & 34, VERNA IND. SYSTEMIC ML
LIMITED ALS LTD DROPS EXAMETHASO AREA, VERNA GOA-403722 DROPS BOTTLE
NE
1281 NDA/MAL/H MEDLEY MEDVIN ATORIN ATORVASTA 10MG MEDLEY INDIA ORAL SOLID 1.0X3.0X1 7/1/2011
DP/2423 PHARMACEUT PHARMA TIN PHARMACEUTICALS LTD,- ORDINARY 0.0
ICALS LIMITED PLOT 18 & 19 SURVEY NO TABLETS TABLET
378/7 & 379/ 2&3 ZARI BLISTER
CAUSEWAY ROAD
KACHIGAM
1282 NDA/MAL/H MACK SHURIK LTD PROBEX MULTI- MULTI- TORQUE INDIA ORAL LIQUID 1.0X225.0 7/1/2000
DP/2426 BROWN SYRUP INGREDIENT INGREDIEN PHARMACEUTICALS LTD - ORDINARY ML
PHARMECEUT T ISSAPUR P.O DAPPAR SYRUPS BOTTLE,1.
ICALS PVT LTD 140506 0X100.0
ML
BOTTLE
1283 NDA/MAL/H SHOSAAN RENE CLONEM CLOTRIMAZO 1%W/W NEM LABORATORIES PVT INDIA TOPICAL 1.0X20.0 7/1/1997
DP/2427 ASIC PACIFIC PHARMACY LTD LE LTD-PLOT NO. 133 EXTERNAL G TUBE
KRISHNA IND. ESTATE, CREAMS
VASAI E,DIST PALGHAR-
401210, MAHARASHTRA
STATE
1284 NDA/MAL/H ERIS LTD BENLE CONSULT CLOTRI- CLOTRIMAZO 1%W/W RUBIEPHARM GERMANY TOPICAL 1.0X20.0 7/1/1998
DP/2428 LIMITED DENK 1% LE ARZNEIMITTEL GMHH-- EXTERNAL G TUBE
CREAM BRUDER-GRIMU, STRABE CREAMS
62, GERMANY
1285 NDA/MAL/H ERIS LTD BENLE CONSULT CLOTRI- CLOTRIMAZO 100MG DENK PHARMA GMBH GERMANY VAGINAL 1.0X6.0 7/1/1998
DP/2429 LIMITED DENK 100 LE &CO.KG- TABLETS PESSARY
VAGINAL PRINZREGENTESTR.79.816 CARTON
75 MUENCHEN,
845529 TITTMONING
GERMANY ARTESAN
PHARMA GMBH & CO. KG -
WENDLANDSTRABE
1,29439
LUCHOW,GERMANY
1286 NDA/MAL/H CADILA ABACUS FORMONID BUDESONIDE 200MCG/ CADILA HEALTHCARE LTD-- INDIA LUNG 1.0X1.0 7/1/2007
DP/2431 HEALTH CARE PHARMA E 200 + 6MCG -SARKHEJ-PLOT ADMINISTRA CANNISTE
LIMITED (AFRICA) FORMOTEROL 417,419,420, SARKHEJ- TION R CARTON
LIMITED FUMARATE BAVLA NH METERED-
NO.8A,VILLAGE: MORAIYA DOSE
TAL: SANAND DISTRICT INHALER
AHMEDABAD 382210
1287 NDA/MAL/H CADILA ABACUS FORMONID BUDESONIDE 100MCG+6 CADILA HEALTHCARE LTD-- INDIA LUNG 1.0X120.0 7/1/2007
DP/2432 HEALTH CARE PHARMA E 100 + MCG -SARKHEJ-PLOT ADMINISTRA METERED
LTD (AFRICA) FORMOTEROL 417,419,420, SARKHEJ- TION CFC- DOSE
LIMITED FUMARATE BAVLA NH FREE CANNISTE
NO.8A,VILLAGE: MORAIYA METERED- R
AHMEDABAD 382210 INHALER
1288 NDA/MAL/H DAR AL DAWA GAMA RISDONE RISPERIDONE 1MG/ML DAR AI DAWA-NA UR JORDAN ORAL LIQUID 1.0X100.0 7/1/2012
DP/2437 DEVELOPMEN PHARMACEUTIC PLANT,AMMAN,JORDAN ORDINARY ML
T AND ALS (U) LIMITED LIQUIDS BOTTLE
INVESTMENT
CO LTD
1289 NDA/MAL/H INTAS, NORVIK HIFENAC ACECLOFENA 100MG INTAS PHARMACEUTICALS INDIA ORAL SOLID 1.0X10.0X 7/1/2006
DP/2438 PHARMACEUT ENTERPRISES C LTD-CAMP ROAD SELAQUI ORDINARY 10.0
ICALS LTD LIMITED DEHRADUN FILM- TABLET
COATED BLISTER
TABLETS
1290 NDA/MAL/H ACINO GOODMAN OLFEN 75 DICLOFENAC 75 MG ACINO PHARMA AG- SWITZERLAN ORAL SOLID 1.0X3.0X1 7/1/2004
DP/2451 PHARMA AG INTERNATIONAL SR SODIUM DORNACHERSTRASSE 114, D RETARD 0.0
LTD CH-4147 AESCH TABLETS TABLET
BLISTER
1291 NDA/MAL/H REGAL REGAL PHARMA DELASED GUAIFENESIN 100MG/5 REGAL KENYA ORAL LIQUID 1.0X100.0 7/1/2007
DP/2452 PHARMACEUT (U) LTD CHEST + MENTHOL ML + PHARMACEUTICALS-PLOT ORDINARY ML
ICALS LTD COUGH 1.1MG/5M 7879/18 BABA DOGO SYRUPS BOTTLE
SYRUP L ROAD NAIROBI
(NON
DROWSY)
1292 NDA/MAL/H ACINO GOODMAN ARTEQUIN ARTESUNATE 200 MG + ACINO PHARMA AG- SWITZERLAN ORAL SOLID 1.0X6.0 7/1/2004
DP/2455 PHARMA AG INTERNATIONAL 600/750 + 250 MG DORNACHERSTRASSE 114, D ORDINARY TABLET
LTD LACTAB MEFLOQUINE CH-4147 AESCH TABLETS BLISTER
1293 NDA/MAL/H XEPA SOUL DELMAW PRISTINEX KETOCONAZO 2%W/W XEPA-SOUL PATTINSON MALAYSIA TOPICAL 2.0X15.0 7/1/2006
DP/2458 PATTISON (M) ENTERPRISES 2% CREAM LE (MALAYSIA) SDA BHD-1-5, EXTERNAL G TUBE
ESTATE, 75250, MELAKA,
MALAYSIA
1294 NDA/MAL/H MYLAN KIMSY MEDS P2 LEVONORGES 0.75MG MYLAN LABORATORIES INDIA ORAL SOLID 1.0X1.0X2 7/1/2007
DP/2459 LABORATORIE LTD TREL LIMITED.--PLOT NO. 1606- ORDINARY .0 TABLET
PLOT NO.20 & 21,
PHARMEZ, SARKHEJ-
BAVLA NATIONAL
1295 NDA/MAL/H COSMOS LTD ASTRA PHARMA BENZHEXOL BENZHEXOL 2MG COSMOS LTD.-RANGWE KENYA ORAL SOLID 1.0X500.0 7/1/2000
DP/2460 (U) LIMITED TABLETS HCL ROAD; OFF LUNGA LUNGA ORDINARY TABLET
2MG ROAD. P.O BOX 414 33, TABLETS CONTAIN
NAIROBI ER,1.0X10
00.0
TABLET
CONTAIN
ER
1296 NDA/MAL/H UMEDICA VITACARE UMERAN DICLOFENAC 100MG UMEDICA LABORATORIES INDIA ORAL SOLID 1.0X10.0X 7/1/2005
DP/2461 LABORATORIE LIMITED SR - 100 PVT, VAPI-PLOT 221, GIDC ORDINARY 10.0
S PVT LTD II, VAPI-396195, INDIA FILM- TABLET
COATED BLISTER
TABLETS
1297 NDA/MAL/H REGAL REGAL PHARMA HISTALIN CHLORPHENI 1.0MG+ REGAL KENYA ORAL LIQUID 1.0X60.0 7/1/1997
DP/2462 PHARMACEUT (U) LTD SYRUP RAMINE 2.5MG+5.0 PHARMACEUTICALS LTD..- ORDINARY ML
ICALS LTD MALEATE/PR MG+7.5M PLOT 7879/18 OFF BABA SYRUPS BOTTLE,1.
OMETHAZINE G+90.0MG DOGO ROAD, RUARAKA 0X5.0 L
/DIPHENHYD +48.0MG/ JERRYCAN
RAMINE/EPH 5ML.
EDRINE/AMM
ONIUM
CHLORIDE/SO
DIUM
CITRATE
1298 NDA/MAL/H CADILA ABACUS NOKLOT CLOPIDOGREL 75MG CADILA HEALTHCARE LTD- INDIA ORAL SOLID 1.0X3.0X1 7/1/2003
DP/2467 HEALTHCARE PHARMA KUNDAIM INDUSTRIAL ORDINARY 0.0
LTD (AFRICA) ESTATE, PLOT NO.203- TABLETS TABLET
LIMITED 213, KUNDAIM GOA, BLISTER
403115, INDIA
1299 NDA/MAL/H GLAXOSMITH UNITED EURAX CROTAMITON 10%W/W NOVATIS CONSUMER SWITZERLAN TOPICAL 1.0X20.0 7/1/2004
DP/2470 KLINE LTD HEALTHCARE HEALTH INC -ZYMA SA-CH- D EXTERNAL G TUBE
DISTRIBUTORS 1260 NYON SWITZERLAND CREAMS
LTD
1300 NDA/MAL/H SHOSAAN RENE TRAN-GEL DICLOFENAC 1%W/W NEM LABORATORIES PVT INDIA TOPICAL 1.0X30.0 7/1/2011
DP/2472 ASIC PACIFIC PHARMACY LTD DIETHYLAMM LTD-133 VASAI RD(E) 401 EXTERNAL G
ONIUM 162 SB MARG. LOWER GELS AND TUBE,1.0X
PAREL MUMBAI SOLS 20.0 G
TUBE
1301 NDA/MAL/H MICRO LABS PHILLIPS NUGREL CLOPIDOGREL 75MG MICRO LABS LTD 92 INDIA ORAL SOLID 1.0X3.0X1 7/1/2010
DP/2473 LTD PHARMACEUTIC SIPCOT -92 SIPCOT ORDINARY 0.0
ALS (UGANDA) HOSUR 635 126 TAMIL FILM- TABLET
LIMITED NADU COATED BLISTER
TABLETS
1302 NDA/MAL/H SANOFI LABOREX TYPHIM VI POLYSACCHA 25MCG SANOFI PASTEUR-1541 FRANCE PARENTERAL 1.0X0.5 7/1/1997
DP/2474 PASTEUR UGANDA RIDES OF AVENUE MARCEL ORDINARY ML PRE-
LIMITED SALMONELLA MERIEUX, 69280 MARCY, PRE-FILLED FILLED
TYPHI(TY2 LETOILE SANOFI PASTEUR SYRINGES SYRINGE
STRAIN) S.A-2,AVENUE PONT (1 DOSE)
PASTEUR 69007 LYON-
FRANCE(BUSINESS
ADDRESS)
1303 NDA/MAL/H WIN- SURGIPHARM URGENDOL TRAMADOL 50MG/ML WIN- MEDICARE LTD- INDIA PARENTERAL 1.0X1.0 7/1/2001
DP/2475 MEDICURE (U) LIMITED INJECTION HYDROCHLOR MODIPURAM -250 ORDINARY ML
LTD IDE 110,UTTAR PRAADESH, AMPOULES AMPOULE
INDIA. ,1.0X2.0
ML
AMPOULE
1304 NDA/MAL/H GLENMARK STAR DERIVA ADAPALENE 0.1%W/W GLENMARK INDIA TOPICAL 1.0X15.0 7/1/2003
DP/2476 PHARMACEUT PHARMACEUTIC AQUEOUS PHARMACEUTICALS LTD- EXTERNAL G TUBE
ICAL LTD ALS LTD GEL PLOT NO E -37, 39 ,D GELS AND
SOLS
1305 NDA/MAL/H WIN- SURGIPHARM DICLOMOL PARACETAM 500MG+50 WIN MEDICARE PVT INDIA ORAL SOLID 1.0X10.0X 7/1/2005
DP/2478 MEDICARE (U) LIMITED PLUS OL+DICLOFEN MG LIMITED-MEERUT, ORDINARY 10.0
PVT LTD AC MUZAFFARNAGER ROAD, TABLETS TABLET
UTTAR PRADESH -INDIA
1306 NDA/MAL/H GALENTIC VITACARE NETRACOR HYDROCORTI 1%W/W GALENTIC PHARMA PVT INDIA TOPICAL 1.0X15.0 7/1/2005
DP/2481 PHARMA LIMITED T SONE LIMITED-R-673,MIDC TTC EXTERNAL G
(PVT)LTD RABALE THANE-BELAPUR OINTMENTS TUBE,1.0X
ROAD,NAVI MUMBAI 20.0 G
TUBE
1307 NDA/MAL/H UMEDICA VITACARE UMETAC- RANITIDINE 150MG UMEDICA LABORATORIES INDIA ORAL SOLID 1.0X10.0X 7/1/2006
DP/2489 LABORATORIE LIMITED 150 PVT LTD-PLOT NO. 221, ORDINARY 10.0
S PVT LTD 2ND PHASE, GIDC, VAPI FILM- TABLET
396195, GUJARAT. INDIA. COATED BLISTER
TABLETS
1308 NDA/MAL/H MACLEODS NORVIK ZETIVAS 20 ATORVASTATI 20MG/10 MACLEODS INDIA ORAL SOLID 1.0X3.0X1 7/1/2008
DP/2496 PDHARMACE ENTERPRISES N/EZETIMIBE MG PHARMACEUTICALS LTD - ORDINARY 0.0
UTICALS LT LIMITED PLOT NO. 25-27, SURVEY FILM- TABLET
KACHIGAM DAMAN
(UT), INDIA.
1309 NDA/MAL/H CIPLA LTD QUALITY NEVIMUNE NEVIRAPINE 50MG/5ML CIPLA LTD --PLOT NO 9, 10 INDIA ORAL LIQUID 1.0X100.0 7/1/2004
DP/2497 CHEMICALS LTD - & 15, PHARMA ZONE, ORDINARY ML
HUMAN PHASE II, SUSPENSION BOTTLE
SECTOR III, INDORE S
SPECIAL ECONOMIC ZONE,
PITHAMPUR, DIST: DHAR,
MADHYA PRADESH – 454
775, INDIA
1310 NDA/MAL/H MACLEODS NORVIK ZETIVAS 10 ATORVASTATI 10MG/10 MACLEODS INDIA ORAL SOLID 1.0X3.0X1 7/1/2008
DP/2498 PDHARMACE ENTERPRISES N/EZETIMIBE MG PHARMACEUTICALS LTD - ORDINARY 0.0
UTICALS LT LIMITED PLOT NO. 25-27, SURVEY FILM- TABLET
KACHIGAM DAMAN
(UT), INDIA.
1311 NDA/MAL/H MACLEODS ROYAL PHARMA CHLORAMP CHLORAMPH 1G MACLEODS INDIA PARENTERAL 1.0X1.0 G 7/1/2007
DP/2500 PHARMACEUT 2011 LIMITED HENICOL ENICOL PHARMACEUTICALS LTD - ORDINARY VIAL
ICALS LTD SODIUM SODIUM PLOT NO. 25-27, SURVEY DRY VIALS
SUCCINATE SUCCINATE NO. 366, PREMIER
INJECTION INDUSTRIAL ESTATE,
BP KACHIGAM DAMAN
(UT), INDIA.
1312 NDA/MAL/H ROYAL ABACUS PROBETA N BETAMETHAS 0.1%W/V+ ATCO LABORATORIES PVT PAKISTAN OPHTHALMI 1.0X7.5 7/1/1997
DP/2502 GROUP PHARMA EYE DROP ONE + 0.5%W/V LTD-B-18,S.I.T.E KARACHI C DROPS ML VIAL
(AFRICA) NEOMYCIN 75700, PAKISTAN
LIMITED
1313 NDA/MAL/H LINCOLN METRO RESTOCIN PARACETAM 500MG+ LINCOLN INDIA ORAL SOLID 1.0X50.0X 7/1/2008
DP/2504 PHARMACEUT PHARMACEUTIC OL + 2MG+ PHARMACEUTICALS ORDINARY 1.0X4.0
ICALS LTD ALS LIMITED CHLORPHENI 2MG + LIMITED-10, 12, 13, TABLETS TABLET
RAMINE 30MG TRIMUL ESTATE, AFTER STRIP
MALEATE + VADSCAR VILLAGE, NEAR
CAFFEINE + KHATRAJ CHOKADI,
PHENYLEPHRI KHATRAJ-382721,
NE HCL GHANDHINAGAR,
GUJARAT, INDIA
1314 NDA/MAL/H WOCKHARDT STAR NADOXIN NADIFLOXACI 1%W/W WOCKHARDT LTD - INDIA TOPICAL 1.0X10.0 7/1/2011
DP/2506 LTD PHARMACEUTIC N VILLAGE KUNJHAL P.O EXTERNAL G
ALS LTD BAROTIWALA DIST SOLAN CREAMS TUBE,1.0X
HIMACHAL PRADESH 20.0 G
TUBE
1315 NDA/MAL/H GITTOES GITTOES HYOSCINE HYOSCINE 20MG/ML NINGBO DAHONGYING CHINA PARENTERAL 1.0X10.0X 7/1/2011
DP/2508 PHARMACEUT PHARMACEUTIC PHARMACEUTICAL CO LTD- ORDINARY 1.0 ML
ICALS LIMITED ALS LIMITED NO.3986 MINZHU ROAD AMPOULES AMPOULE
NINGBO CITY ZHEJIANG
1316 NDA/MAL/H BETA BETA OPELE BENZYL 25%W/V BETA HEALTHCARE KENYA TOPICAL 1.0X50.0 7/1/1997
DP/2509 HEALTHCARE HEALTHCARE LOTION BENZOATE INTERNATIONAL LTD - - EXTERNAL ML
UGANDA UGANDA PLOT LOTIONS BOTTLE
LIMITED LIMITED NO.209/6554,MOGADISHU
INDUSTRIAL AREA,
P.O.BOX 42569-001000
NAIROBI,KENYA
1317 NDA/MAL/H PANACEA VITACARE GIRO ORDNIDAZOL 500MG PANACEA BIOTEC LTD-- INDIA ORAL SOLID 1.0X5.0X2 7/1/2013
DP/2510 BIOTEC LTD LIMITED E MALPUR, BADDI, TEHSIL, ORDINARY .0X10.0
NALAGARH, DIST. SOLAN FILM- TABLET
HIMACHAL PRADESH – COATED BLISTER
173 205 TABLETS
1318 NDA/MAL/H BETA BETA ULTIVA REMIFENTANI 5MG GLAXOSMITHKLINE ITALY PARENTERAL 1.0X1.0 7/1/1999
UGANDA UGANDA 5MG STRADA PROVINCIALE DRY VIALS CARTON
S.POLO DI TORRILE
(PARMA)
1319 NDA/MAL/H REGAL REGAL PHARMA UNIPEN PHENOXYME 125MG/5 REGAL KENYA ORAL LIQUID 1.0X100.0 7/1/1997
DP/2513 PHARMACEUI (U) LTD DRY SYRUP THYLPENICILL ML PHARMACEUTICALS LTD- ORDINARY ML
CALS LTD IN BABA DOGO ROAD, DRY BOTTLE
RAURAKA,NAIROBI,KENYA SUSPENSION
S/SYRUPS/D
ROPS
1320 NDA/MAL/H MEGA ABACUS VITA CAP MULTI- MULTI- MEGA LIFE SCIENCES THAILAND ORAL SOLID 1.0X3.0X1 7/1/2009
DP/2519 LIFESCIENCES PHARMA INGREDIENT INGREDIEN PUBLIC COMPANY ORDINARY 0.0
(AUSTRALIA) (AFRICA) T LIMITED-384 SOIB CAPSULES CAPSULE
PTY LTD LIMITED PATTANA 3 RD BANGPOO BLISTER,1.
INDUSTRIAL ESTATE 0X10.0X10
SAMUTPRAKARN 10280 .0
CAPSULE
BLISTER
1321 NDA/MAL/H MEDLEY MEDVIN MOTINOR DOMPERIDO 10MG MEDLEY INDIA ORAL SOLID 1.0X10.0X 7/1/2005
DP/2521 PHARMACEUT PHARMA M NE PHARMACEUTICALS LTD- ORDINARY 10.0
ICALS LTD LIMITED PLOT NO.18 AND 19, TABLETS TABLET
SURVEY NO.378/8 & BLISTER
ESTATE, KACHIGAM,
DAMAN-396210 INDIA
1322 NDA/MAL/H MEDLEY MEDVIN PANTAZ PANTOPRAZO 40MG MEDLEY INDIA ORAL SOLID 1.0X10.0X 7/1/2005
DP/2522 PHARMACEUT PHARMA TABLETS LE PHARMACEUTICALS LTD- ORDINARY 10.0
ICALS LTD LIMITED PLOT NO 18 & 19, SURVEY ENTERIC- TABLET
NO. 378/7& 8,379/2&3 COATED BLISTER
ZARI TABLETS
CAUSEWAY ROAD,,
KACHIGAM, DAMAN-396
210
1323 NDA/MAL/H SHOSAAN RENE SULPHUR SULPHUR 10%W/W NEM LABORATORIES PVT INDIA TOPICAL 1.0X25.0 7/1/1997
DP/2523 ASIC PACIFIC PHARMACY LTD OINTMENT LTD---133 VASAI RD(E) 401 EXTERNAL G TUBE
162 SB MARG. LOWER OINTMENTS
PAREL MUMBAI
1324 NDA/MAL/H MEDLEY MEDVIN PRIMODIL- AMLODIPINE 5MG MEDLEY INDIA ORAL SOLID 1.0X10.0X 7/1/2005
DP/2524 PHARMACEUT PHARMA 5 BESYLATE PHARMACEUTICALS LTD- ORDINARY 10.0
ICALS LTD LIMITED PLOT NO 18 & 19, SURVEY TABLETS TABLET
NO. 378/7& 8,379/2&3 BLISTER
ZARI
CAUSEWAY ROAD,,
KACHIGAM, DAMAN-396
210
1325 NDA/MAL/H ERIS LTD BENLE CONSULT DICLO- DICLOFENAC 100MG DENK PHARMA GMBH GERMANY ORAL SOLID 10.0X10.0 7/1/1998
DP/2525 LIMITED DENK 100 SODIUM &CO.KG-- RETARD TABLET
RETARD PRINZREGENTESTR.79.816 TABLETS BLISTER,1.
75 MUENCHEN, 0X10.0
GERMANY, GOLLSTR, 1-D- TABLET
845529 TITTMONING BLISTER
GERMANY
1326 NDA/MAL/H REGAL REGAL PHARMA UNISTEN CLOTRIMAZO 500MG & 1 REGAL KENYA VAGINAL 1.0X1.0 7/1/2009
DP/2526 PHARMACEUI (U) LTD COMBI LE %W/W PHARMACEUTICALS LTD- COMBINATI PESSARY
CALS LTD PACK BABA DOGO ROAD, ON PACK BLISTER +
RAURAKA,NAIROBI,KENYA TABLETS 1*20G
TUBE
1327 NDA/MAL/H CIPLA LTD. QUALITY ACIVIR ACICLOVIR 5%W/W CIPLA LTD-VERNA INDIA TOPICAL 1.0X10.0 7/1/1998
DP/2527 CHEMICALS LTD - CREAM INDUSTRIAL ESTATE, GOA EXTERNAL G
HUMAN CREAMS TUBE,1.0X
5.0 G
TUBE
1328 NDA/MAL/H LABORATORY HARLEYS LABESTEN CLOTRIMAZO 1%W/W LABORATORY & ALLIED KENYA TOPICAL 1.0X1.0X1 7/1/1997
DP/2528 AND ALLIED UGANDA LE LTD.---PLOT 209/10349 EXTERNAL 5.0 G
LTD LIMITED OFF MOMBASA RD CREAMS TUBE,1.0X
NAIROBI 1.0X20.0
G TUBE
1329 NDA/MAL/H GUILIN STAR G-CEFTRIA CEFTRIAXONE 1G GUILIN PHARMACEUTICAL CHINA PARENTERAL 1.0X1.0 G 7/1/2012
DP/2529 PHARMACEUT PHARMACEUTIC CO LTD-NO.43 QILIDIAN ORDINARY VIAL + 10
ICALS CO.LTD ALS LTD ROAD GUILIN 541004 DRY VIALS ML
GUANGXI AMPOULE
WFI,1.0X1
.0X50.0 G
VIAL,1.0X
1.0 VIAL
CARTON
1330 NDA/MAL/H NORVATIS LABOREX TOBREX TOBRAMYCIN 0.3%W/V ALCON COUVREUR NV- BELGIUM OPHTHALMI 1.0X5.0 7/1/1997
DP/2545 PHARMA AG- UGANDA RIJKSWEG 14, B-2870 C DROPS ML
D
1331 NDA/MAL/H ASTRA LIFE ASTRA PHARMA AZY-250 AZITHROMYCI 250MG ASTRA LIFE CARE (INDIA) INDIA ORAL SOLID 1.0X6.0 7/1/2011
DP/2549 CARE (INDIA) (U) LIMITED N PVT.LTD-PLOT NO. 57/P, ORDINARY TABLET
PVT LTD SARKHEJ-BAVLA TABLETS BLISTER
HIGHWAY, POST RAJODA-
AHMEDABAD INDIA
1332 NDA/MAL/H AJANTA ABACUS CAROFIT VITAMIN C/ 150MG/10 AJANTA PHARMA LIMITED- INDIA ORAL SOLID 1.0X3.0X1 7/1/2005
DP/2552 PHARMA LTD PHARMA VITAMIN A/ MG/75MG B-4-5-6, MIDC AREA ORDINARY 0.0
(AFRICA) ZINC PAITHAN, AURANGABAD, TABLETS TABLET
LIMITED SULPHATE 431148 BLISTER
DIST:AURANGABAD
MAHARASHTRA, INDIA.
1333 NDA/MAL/H GLENMARK STAR ESOZ-20 ESOMEPRAZO 20MG GLENMARK INDIA ORAL SOLID 1.0X10.0X 7/1/2003
DP/2553 PHARMACEUT PHARMACEUTIC LE PHARMACEUTICALS LTD- ORDINARY 10.0
ICAL LTD. ALS LTD PLOT NO E -37, 39 ,D TABLETS TABLET
STRIP,1.0X
10.0
TABLET
STRIP
1334 NDA/MAL/H GLENMARK STAR ESOZ ESOMEPRAZO 40MG GLENMARK INDIA ORAL SOLID 1.0X1.0X1 7/1/2005
DP/2554 PHARMACEUT PHARMACEUTIC LE PHARMACEUTICALS LTD- ORDINARY 0.0
ICAL LTD. ALS LTD PLOT NO E -37, 39 ,D TABLETS TABLET
STRIP,1.0X
10.0X10.0
TABLET
STRIP
1335 NDA/MAL/H COSMOS LTD ASTRA PHARMA PHENOBAR PHENOBARBI 30MG COSMOS LIMITED-- KENYA ORAL SOLID 1.0X10.0X 7/1/1998
DP/2555 (U) LIMITED BITONE TONE RANGWA ROAD, OFF ORDINARY 10.0
TABLETS BP LUNGA LUNGA ROAD,P.O TABLETS TABLET
30MG BOX 414 33, NAIORBI BLISTER,1.
TABLET
CONTAIN
ER,1.0X10
0.0
TABLET
CONTAIN
ER
1336 NDA/MAL/H GILEAD MEDICAL TRUVADA EMTRICITABI 200MG/30 PATHEON INC-ADDRESS: UNITED ORAL SOLID 1.0X30.0 7/1/2005
DP/2556 SCIENCE INC ACCESS NE/TENOFOV 0MG 2100 SYNTEX COURT, STATES ORDINARY TABLET
(UGANDA) IR MISSISSAUGA, ONTARIO TABLETS CONTAIN
LIMITED L5N 7K9 ER
COUNTRY: CANADA
TAKEDA GMBH-16515
ORANIENBURG GERMANY
ASPEN PHARMACARE-7
FAIRCLOUGH ROAD
KORSTEN PORT
ELIZABETH, 6020 SOUTH
AFRICA
1337 NDA/MAL/H REMEDICA GOODMAN EPSITRON CAPTOPRIL 25MG REMEDICA LIMITED- CYPRUS ORAL SOLID 1.0X10.0X 7/1/1999
DP/2557 LTD INTERNATIONAL 25 TABLETS LIMASSOL INDUSTRIAL ORDINARY 10.0
BLISTER
1338 NDA/MAL/H RENE RENE MYCOREN NYSTATIN 100000 RENE INDUSTRIES LTD- UGANDA ORAL 1.0X30.0 7/1/2007
DP/2558 INDUSTRIES INDUSTRIES SUSPENSIO I.U/ML 680,KAMULI,KIREKA TOPICAL ML
LTD LIMITED N KAMPALA,UGANDA SUSPENSION BOTTLE
S
1339 NDA/MAL/H RENE RENE ERYTHROR ERYTHROMYC 250MG RENE INDUSTRIES LTD- UGANDA ORAL SOLID 1.0X10.0X 7/1/2007
DP/2559 INDUSTRIES INDUSTRIES EN IN STEARATE PLOT 680, KAMULI ROAD, ORDINARY 10.0
KAMPALA BLISTER,1.
0X1000.0
TABLET
CONTAIN
ER
1340 NDA/MAL/H PHARMATHE GOODMAN LANOMYCI AMIKACIN 500MG PHARMATHEN S.A- GREECE PARENTERAL 1.0X2.0 7/1/1997
DP/2561 N LTD INTERNATIONAL N SULPHATE 6,DERVENAKION ORDINARY ML
LTD STR,PALLINI,AHICA AMPOULES AMPOULE
GREECE
1341 NDA/MAL/H CADILA ABACUS TRAMAZAC TRAMADOL 50MG/ML CADILA HEALTHCARE LTD-- INDIA PARENTERAL 1.0X2.0 7/1/2001
DP/2565 HEALTHCARE PHARMA INJECTION HYDROCHLOR -SARKHEJ-PLOT ORDINARY ML
LTD (AFRICA) IDE 417,419,420, SARKHEJ- AMPOULES AMPOULE
LIMITED BAVLA NH ,1.0X5.0X2
NO.8A,VILLAGE: MORAIYA .0 ML
TAL: SANAND DISTRICT AMPOULE
AHMEDABAD 382210
1342 NDA/MAL/H CADILA ABACUS CIPROBID- CIPROFLOXAC 500MG CADILA HEALTHCARE INDIA ORAL SOLID 10.0X10.0 7/1/1997
DP/2567 HEALTH CARE PHARMA 500 IN LIMITED--KUNDAIM ORDINARY TABLET
LIMITED (AFRICA) INDUSTRIAL ESTATE, PLOT FILM- BLISTER
LIMITED NO. 203-213, COATED
INDIA S.KANT
HEALTHCARE LIMITED--
PLOT NO. 1802-1805,GIDC
PHASE II-
396195,DIST.VALSAD,GUJA
RAT,INDIA PINNACLE LIFE
SCIENCE PVT LTD-KHASRA
1343 NDA/MAL/H GLAXO UNITED ZINNAT CEFUROXIME 500MG GLAXOSMITHKLINE UK UNITED ORAL SOLID 1.0X10.0 7/1/1997
DP/2568 WELLCOME HEALTHCARE AXETIL LTD-HARMIRE RD KINGDOM ORDINARY TABLET
(KENYA) LTD DISTRIBUTORS BARNARD CASTLE FILM- BLISTER,1.
LTD DURHAM, DL12DT UNITED COATED 0X50.0
TABLETS TABLET
CARTON
1344 NDA/MAL/H SANOFI SURGIPHARM NO-SPA DROTAVERIN 40MG/2ML CHINOIN HUNGARY PARENTERAL 1.0X2.0 7/1/1998
DP/2569 AVENTIS (U) LIMITED E PHARMACEUTICAL AND ORDINARY ML
HYDROCHLOR CHEMICAL WORKS AMPOULES AMPOULE
IDE PRIVATE CO. LTD
CSANYIKVOLGY SITE-
CSANYIKVOLGY, P.O.BOX
565.3510, MISKOLC,
HUGARY
1345 NDA/MAL/H REMEDICA GOODMAN AMOXAPEN AMOXYCILLIN 250MG REMEDICA LIMITED - CYPRUS ORAL SOLID 10.0X10.0 7/1/1997
DP/2570 LTD INTERNATIONAL 250 AHARNON STREET, ORDINARY CAPSULE
LTD CAPSULES LIMASSOL INDUSTRIAL CAPSULES BLISTER,1
ESTATE. LIMASSOL, 00.0X10.0
CYPRUS 3056, CYPRUS CAPSULE
BLISTER
1346 NDA/MAL/H GITTOES GITTOES CO- ARTEMETHER 180 MG + AGOG PHARMA LTD-PLOT INDIA ORAL LIQUID 1.0X60.0 7/1/2010
DP/2571 PHARMACEUT PHARMACEUTIC METHER + 1080 MG NO.33,SECTOR ORDINARY ML
ICALS LIMITED ALS LIMITED LUMEFANTRI II,VASAI,TALUKA INDL CO- DRY BOTTLE,1.
NE OP ESTATE LTD,GAURAI SUSPENSION 0X30.0 ML
PADA,VASAI(E)DIST.THAN S/SYRUPS/D BOTTLE
E INDIA ROPS
1347 NDA/MAL/H HILTON HEALTHCARE MYTEKA MONTELUKAS 10MG HILTON PHARMA (PVT) PAKISTAN ORAL SOLID 1.0X2.0X7 7/1/2005
DP/2575 PHARMA LTD. T SODIUM LTD-PLOT 13 SECTOR 15 ORDINARY .0 TABLET
(PVT) LTD KORANGI INDUSTRIAL TABLETS BLISTER
AREA KARACHI
1348 NDA/MAL/H RENE RENE RENEQUIN CHLOROQUIN 250MG RENE INDUSTRIES LTD- UGANDA ORAL SOLID 1.0X250.0 7/1/2000
DP/2576 INDUSTRIES INDUSTRIES E TABLETS E PHOSPHATE 680,KAMULI,KIREKA ORDINARY TABLET
LTD LIMITED KAMPALA,UGANDA TABLETS CONTAIN
ER,1.0X10
00.0
TABLET
CONTAIN
ER
1349 NDA/MAL/H TORRENT KARURI TOPCEF 200 CEFIXIME 200MG TORRENT INDIA ORAL SOLID 1.0X5.0X1 7/1/2005
ICALS LTD ALS LTD. INDRAD-382 721, FILM- TABLET
DIST.MEHSANA,INDIA.AT: COATED BLISTER,1.
VILL.MANAKPUR,TEH.NAL TABLETS 0X10.0X10
AGARH,DIST.SOLAN(H.P.) .0 TABLET
BLISTER
1350 NDA/MAL/H REGAL REGAL PHARMA MAGNOMI MAGNESIUM 250MG+12 REGAL KENYA ORAL SOLID 1.0X10.0X 7/1/1997
DP/2578 PHARMACEUT (U) LTD NT TABLETS TRISILICATE+ 0MG PHARMACEUTICALS LTD- ORDINARY 10.0
ICALS LTD ALUMINIUM BABA DOGO ROAD, TABLETS TABLET
HYDROXIDE RAURAKA,NAIROBI,KENYA BLISTER,1.
0X100.0X1
0.0
TABLET
BLISTER,1.
0X50.0X2.
0 TABLET
BLISTER,1.
0X500.0
1351 NDA/MAL/H ACINO GOODMAN ARTEQUIN ARTESUNATE 300 MG + ACINO PHARMA AG- SWITZERLAN ORAL SOLID 1.0X6.0 7/1/2005
DP/2579 PHARMA AG INTERNATIONAL 300/375 + 375 MG DORNACHERSTRASSE 114, D ORDINARY TABLET
LTD LACTAB MEFLOQUINE CH-4147 AESCH TABLETS BLISTER
1352 NDA/MAL/H ABACUS ABACUS HEDON PARACETAM 250 MG+ REGAL KENYA ORAL SOLID 1.0X50.0X 7/1/1998
DP/2580 PHARMA LTD PHARMA TABLETS OL + ASPIRIN 300 MG + PHARMACEUTICALS LTD- ORDINARY 2.0
(AFRICA) + CAFFEINE 30 MG BABA DOGO ROAD, TABLETS TABLET
LIMITED RAURAKA,NAIROBI,KENYA STRIP
LINCOLN
PHARMACEUTICALS LTD--
TRIMUL ESTATE AFER
VODSAR VILLAGE KHATJAT
382 721 GUJARAT VADSAR
P.O.J TALUKA KALOH DIST
GANDHINAGAR INDIA
MILAN LABORATORIES
1353 NDA/MAL/H E DENK OHG BENLE CONSULT ATENOLOL ATENOLOL 50MG ARTESAN PHARMA GMBH GERMANY ORAL SOLID 1.0X10.0X 7/1/2005
DP/2593 LIMITED DENK 50 & CO. KG - ORDINARY 10.0
WENDLANDSTRABE FILM- TABLET
1,29439 COATED BLISTER
LUCHOW,GERMANY TABLETS
1354 NDA/MAL/H GITTOES GITTOES FEF FERROUS 200MG + AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1.0X1000. 7/1/2009
DP/2594 PHARMACEUT PHARMACEUTIC SULPHATE + 0.4MG NO.33,SECTOR ORDINARY 0 TABLET
ICALS LIMITED ALS LIMITED FOLIC ACID II,VASAI,TALUKA INDL CO- TABLETS CONTAIN
E INDIA TABLET
BLISTER
1355 NDA/MAL/H MEDOCHEMIE BOOTS ZEPILEN CEFAZOLIN 1000MG MEDOCHEMIE LTD CYPRUS PARENTERAL 1.0X10.0 7/1/2009
DP/2595 LTD PHARMACEUTIC COGOLS FACILITY-1-10 ORDINARY VIAL
ALS LIMITED CONSTANTINOUPOLEOS DRY VIALS CARTON
STREET, ZAKAKI,
LIMASSOL, CYPRUS
1356 NDA/MAL/H E DENK OHG BENLE CONSULT PARA DENK PARACETAM 250MG RUBIEPHARM GERMANY RECTAL 1.0X5.0 7/1/2005
DP/2597 LIMITED 250 OL ARZNEIMITTEL GMHH - SYSTEMIC SUPPOSIT
GERMANY BENE- SUPPOSITORI ORY
ARZNEIMITTEL GMBH- ES STRIP,1.0X
HERTERICHSTR. 1,81479 2.0X5.0
MUENCHEN, GERMANY SUPPOSIT
ORY STRIP
1357 NDA/MAL/H IND SWIFT PLANET CLARIE-OD CLARITHROM 500MG IND-SWIFT-LTD,-GLOBAL INDIA ORAL SOLID 1.0X10.0X 7/1/2008
DP/2600 LTD PHARMACEUTIC YCIN(EXTENT BUSINESS UNIT, RETARD 1.0X7.0
ALS UGANDA ED RELEASE) JAWAHARPUR, OFF NH-21 FILM- TABLET
LTD DERABASSI COATED BLISTER
TABLETS
1358 NDA/MAL/H MEDOCHEMIE BOOTS AXETINE CEFUROXIME 750MG MEDOCHEMIE LTD CYPRUS PARENTERAL 1.0X10.0 7/1/2009
DP/2601 LTD PHARMACEUTIC 750MG COGOLS FACILITY-1-10 ORDINARY VIAL
ALS LIMITED CONSTANTINOUPOLEOS DRY VIALS CARTON
STREET, ZAKAKI,
LIMASSOL, CYPRUS
1359 NDA/MAL/H CIPLA LTD QUALITY VIRADAY TENOFOVIR + 300 MG + CIPLA LTD .-PLOT NO. S- INDIA ORAL SOLID 1.0X30.0 7/1/2011
DP/2603 CHEMICALS LTD - EMTRICITABI 200 MG + 103 TO S-105, S-107 TO S- ORDINARY TABLET
HUMAN NE + 600 MG 112, L-147 TO L-1147-1, TABLETS BOTTLE
EFAVIRENZ VERNA ELECTRONIC CITY
GOA
1360 NDA/MAL/H USV PRIVATE ABACUS GROVIT MULTI- MULTI- SAKAR HEALTHCARE PVT INDIA ORAL LIQUID 1.0X100.0 7/1/2000
DP/2604 LIMITED PHARMA SYRUP INGREDIENT INGREDIEN LTD-SAKAR HEALTHCARE ORDINARY ML
(AFRICA) T PVT LTD, BLOCK NO 10-13, SYRUPS BOTTLE
LIMITED M.N. DESA
1361 NDA/MAL/H GITTOES GITTOES ATROPINE ATROPINE 1MG/ML NINGBO DAHONGYING CHINA PARENTERAL 1.0X10.0X 7/1/2009
DP/2610 PHARMACEUT PHARMACEUTIC PHARMACEUTICALS LTD- ORDINARY 1.0 ML
ICALS LIMITED ALS LIMITED NO. 396 MIN AMPOULES AMPOULE
1362 NDA/MAL/H RENE RENE RENIRON MULTI- MULTI- RENE INDUSTRIES LTD- UGANDA ORAL SOLID 3.0X10.0 7/1/2005
DP/2612 INDUSTRIES INDUSTRIES INGREDIENT INGREDIEN PLOT 680, KAMULI ROAD, ORDINARY CAPSULE
LIMITED LIMITED T KIREKA, P.O BOX 6034, CAPSULES BLISTER
KAMPALA
1363 NDA/MAL/H ASTRA MACNAUGHTON SYMBICORT BUDESONIDE 160MCG+4 ASTRAZENECA AB,- SWEDEN LUNG 1.0X60.0 7/1/2001
DP/2615 ZENECA AB LIMITED TURBUHAL +FORMOTER .5MCG/DO GARTUNA & SNACKVIKEN ADMINISTRA DOSE
ER OL SE STOCKHOLM TION CANNISTE
METERED- R
DOSE
POWDER
INHALER
1364 NDA/MAL/H BLUE CROSS STAR BLUDROX CEFADROXIL 250MG BLUE CROSS INDIA ORAL SOLID 10.0X10.0 7/1/2001
DP/2617 LABORATORIE PHARMACEUTIC TABLETS LABORATORIES LIMITED-A- ORDINARY TABLET
S LIMITED ALS LTD DISPERSABL 12 MIDC AMBAD-NASHIK- TABLETS STRIP
E 422010 MAHARASHTRA
STATE, INDIA
1365 NDA/MAL/H MICRO LABS LABOREX AZILIDE-500 AZITHROMYCI 500MG MICRO LABS LTD--NO 92, INDIA ORAL SOLID 1.0X1.0X3 7/1/2004
DP/2628 LTD UGANDA N SIPCOT, HOSUR-635 126,, ORDINARY .0 TABLET
LIMITED TAMIL NADU, INDIA FILM- BLISTER
COATED
TABLETS
1366 NDA/MAL/H DENK BENLE CONSULT IBUPROFEN IBUPROFEN 400MG DENK PHARMA GMBH GERMANY ORAL SOLID 1.0X2.0X1 7/1/2005
DP/2647 PHARMA LIMITED DENK &CO.KG-- ORDINARY 0.0
400MG PRINZREGENTESTR.79.816 FILM- TABLET
75 MUENCHEN, COATED BLISTER,1.
GERMANY, GOLLSTR, 1-D- TABLETS 0X1.0X10.
845529 TITTMONING 0 TABLET
GERMANY BLISTER,1.
0X10.0X10
.0 TABLET
BLISTER
1367 NDA/MAL/H E DENK OHG BENLE CONSULT PARA DENK PARACETAM 125MG RUBIEPHARM GERMANY RECTAL 1.0X5.0 7/1/2005
DP/2648 LIMITED 125 OL ARZNEIMITTEL GMHH - SYSTEMIC SUPPOSIT
GERMANY BENE- SUPPOSITORI ORY
ARZNEIMITTEL GMBH- ES STRIP,1.0X
HERTERICHSTR. 1,81479 2.0X5.0
MUENCHEN, GERMANY SUPPOSIT
ORY STRIP
1368 NDA/MAL/H DENK BENLE CONSULT VIT-B-DENK THIAMINE 100MG + DENK PHARMA GMBH & GERMANY ORAL SOLID 1.0X10.0 7/1/2005
DP/2650 PHARMA LIMITED HCL + 200MG CO.-PRINZREGENTENSTR. ORDINARY TABLET
PYRIDOXINE 79, 81675 MÜNCHEN, FILM- CARTON,1
HCL GÖLLSTR. 1, 84529 COATED .0X10.0X1
TITTMONING, GERMANY TABLETS 0.0
TABLET
BLISTER
1369 NDA/MAL/H REGAL REGAL PHARMA RINAVIT MULTIVITAMI MULTI- REGAL KENYA ORAL LIQUID 1.0X60.0 7/1/1997
DP/2651 PHARMACEUI (U) LTD SYRUP N INGREDIEN PHARMACEUTICALS LTD- ORDINARY ML
CALS LTD T BABA DOGO ROAD, SYRUPS BOTTLE,1.
ML
BOTTLE
1370 NDA/MAL/H SANOFI - SURGIPHARM FLAGENTYL SECNIDAZOLE 500MG FAMAR LYON-29 AVENUE FRANCE ORAL SOLID 1.0X4.0 7/1/1997
DP/2652 AVENTIS (U) LIMITED TABLETS CHARLES DE GAULLE ORDINARY TABLET
SAINT TABLETS BLISTER
1371 NDA/MAL/H BLUE CROSS STAR SONADERM- CLOBETASOL 0.05%W/W BLUE CROSS INDIA TOPICAL 1.0X10.0 7/1/2007
DP/2653 LABORATORIE PHARMACEUTIC GM + + 2% LABORATORIES LTD-L-17, EXTERNAL G TUBE
S LTD ALS LTD MICONAZOLE W/W+ VERNA INDUSTRIAL CREAMS
+ 0.1%W/W ESTATE,VERNA GOA-
GENTAMICIN 403722
1372 NDA/MAL/H MEDICAL KARURI BEBE VIT VITAMIN A+ 1500IU+ MEDICAL UNION EGYPT ORAL LIQUID 1.0X30.0 7/1/2006
DP/2654 UNION PHARMACEUTIC VITAMIN 400IU+ PHARMACEUTICALS -HEAD ORDINARY ML
PHARMACEUT ALS LTD. D3+VITAMIN 5MG+ OFFICE 36 6TH DISTRICT LIQUIDS BOTTLE
ICALS E+ VITAMIN C 40MG+0.5 NASR CITY CAIRO EGYPT
+VITAMIN B1 MG+0.6M PLANT ABUSULTAN
+ VITAMIN B2 G ISMAILIA
1373 NDA/MAL/H SHAIGAN HEALTHCARE XEPIL CARBAMAZEP 200MG SHAIGAN PAKISTAN ORAL SOLID 1.0X10.0X 7/1/1997
DP/2657 PHARMACEUT LTD. INE PHARMACEUTICALS (PVT) ORDINARY 5.0
PAKISTAN
1374 NDA/MAL/H ELDA REDDYS SENSINIL LIDOCAINE 2%W/V CLARIS INJECTABLE INDIA PARENTERAL 1.0X5.0 7/1/2005
DP/2670 INTERNATION PHARMA LIMITED--CHACHARWADI ORDINARY ML
AL DMCC LIMITED VASANA AHMEDABAD VIALS VIAL,1.0X
GUJARAT 20.0 ML
VIAL,1.0X
30.0 ML
VIAL,1.0X
5.0X20.0
ML VIAL
1375 NDA/MAL/H CIPLA LTD.. QUALITY DUOLIN IPRATROPIU 500MG + CIPLA LTD.- -PLOT NO INDIA LUNG 4.0X5.0X2 7/1/2005
DP/2671 CHEMICALS LTD - RESPULES M BROMIDE 2.5 MG L/139 TO L/146, VERNA ADMINISTRA .5 ML
HUMAN & /2.5ML INDUSTRIAL ESTATE, TION LIQUID VIAL
SALBUTAMOL VERNA, SOUTH GOA FOR
DISTRICT, 403722 GOA INHALATION
1376 NDA/MAL/H PHARMATHE GOODMAN STRADUME ALLOPURINOL 300MG PHARMATHEN S.A- GREECE ORAL SOLID 1.0X28.0 7/1/1997
DP/2673 N LTD INTERNATIONAL L 6,DERVENAKION ORDINARY TABLET
LTD STR,PALLINI,AHICA TABLETS BOTTLE,1.
GREECE 0X25.0
TABLET
BOTTLE
1377 NDA/MAL/H LEBEN ANDYCO LIBITUS TERBUTALINE 1.25MG/ LEBEN LABORATORIES PVT INDIA ORAL LIQUID 1.0X100.0 7/1/2011
DP/2675 LABORATORIE PHARMACY PLUS SYRUP / 4MG/ 50 LTD --L4 PHASEIII M.I.D.C ORDINARY ML
S PVT LTD (UGANDA) LTD BROMHEXINE MG AKOLA 444 104 SYRUPS BOTTLE
/ MAHARASHTRA
GUAIPHENESI
N
1378 NDA/MAL/H CIPLA LTD. QUALITY FORCAN- FLUCONAZOL 150MG CIPLA LTD -PLOT NO. L- INDIA ORAL SOLID 1.0X5.0 7/1/2004
DP/2678 CHEMICALS LTD - 150 E 139, VERNA, GOA 403 722 ORDINARY CAPSULE
HUMAN INDIA CAPSULES BLISTER
1379 NDA/MAL/H CIPLA LTD. QUALITY ALERID CETIRIZINE 5MG/5ML CIPLA LIMITED-PLOT NO 9 INDIA ORAL LIQUID 1.0X30.0 7/1/2006
DP/2679 CHEMICALS LTD - SYRUP HYDROCHLOR & 10, PHARMA ZONE, ORDINARY ML
HUMAN IDE PHASE II, INDORE SPECIAL SYRUPS BOTTLE
ECONOMIC ZONE,
775, INDIA.
1380 NDA/MAL/H RENE RENE AMPIREN AMPICILLIN 250MG RENE INDUSTRIES LTD- UGANDA ORAL SOLID 1.0X1000. 7/1/2007
DP/2680 INDUSTRIES INDUSTRIES CAPSULES TRIHYDRATE 680,KAMULI,KIREKA ORDINARY 0
LIMITED LIMITED KAMPALA,UGANDA CAPSULES CAPSULE
CONTAIN
ER
1381 NDA/MAL/H RENE RENE AMOXIREN AMOXICILLIN 250MG RENE INDUSTRIES LTD- UGANDA ORAL SOLID 1.0X1000. 7/1/2007
DP/2681 INDUSTRIES INDUSTRIES TRIHYDRATE 680,KAMULI,KIREKA ORDINARY 0
LIMITED LIMITED KAMPALA,UGANDA CAPSULES CAPSULE
CONTAIN
ER
1382 NDA/MAL/H RENE RENE VITAMIN C ASCORBIC 100MG RENE INDUSTRIES LTD- UGANDA ORAL SOLID 1.0X1000. 7/1/2005
DP/2683 INDUSTRIES INDUSTRIES ACID 680,KAMULI,KIREKA ORDINARY 0 TABLET
LTD LIMITED KAMPALA,UGANDA CHEWABLE CONTAIN
TABLETS ER
1383 NDA/MAL/H RENE RENE RENEDOL(S PARACETAM 120MG/5 RENE INDUSTRIES LTD- UGANDA ORAL LIQUID 1.0X1.0X1 7/1/2007
DP/2685 INDUSTRIES INDUSTRIES USPENSION OL ML 680,KAMULI,KIREKA ORDINARY 00.0 ML
LTD LIMITED ) KAMPALA,UGANDA SUSPENSION BOTTLE,1.
S 0X1.0X60.
0 ML
BOTTLE
1384 NDA/MAL/H DAR AL DAWA GAMA AMOXYDAR AMOXICILLIN 250MG/5 DAR AL DAWA-NA'UR JORDAN ORAL LIQUID 1.0X100.0 7/1/2009
DP/2686 DEVELOPMEN PHARMACEUTIC FORTE TRIHYDRATE ML PLANT AMMAN ORDINARY ML
T AND ALS (U) LIMITED SUSPENSION BOTTLE
INVESTMENT S
CO LTD
1385 NDA/MAL/H M.J TATA UGANDA TEICO 1000 CEFEPIME 1000MG M.J BIOPHARM PVT LTD- INDIA PARENTERAL 1.0X1000. 7/1/2013
DP/2687 BIOPHARM LIMITED TALOJA DISTRICT RAIGAD ORDINARY 0 MG VIAL
PVT LTD 410208 NAVI MUMBAI DRY VIALS
1386 NDA/MAL/H ABACUS ABACUS AMOXYN- AMOXICILLIN 250MG REYOUNG CHINA ORAL SOLID 1.0X10.0X 7/1/2011
DP/2688 PHARMA (A) PHARMA 250 PHARMACEUTICAL CO. ORDINARY 10.0
LTD. (AFRICA) LTD-NO. 6 ERLANGSHAN CAPSULES CAPSULE
LIMITED ROAD, YIYUAN, BLISTER,1.
SHANDONG 256100 0X100.0X1
0.0
CAPSULE
BLISTER
1387 NDA/MAL/H ABACUS ABACUS AMPIMAX- AMPICILLIN 250MG REYOUNG CHINA ORAL SOLID 1.0X10.0X 7/1/2011
DP/2690 PHARMA (A) PHARMA 250 PHARMACEUTICAL CO. ORDINARY 10.0
LTD. (AFRICA) LTD-NO. 6 ERLANGSHAN CAPSULES CAPSULE
LIMITED ROAD, YIYUAN, BLISTER,1.
SHANDONG 256100 0X1000.0
CAPSULE
CONTAIN
ER
1388 NDA/MAL/H ABACUS ABACUS AMPIMAX- AMPICILLIN 500MG REYOUNG CHINA PARENTERAL 1.0X50.0X 7/1/2011
DP/2691 PHARMA (A) PHARMA 500 PHARMACEUTICAL CO. ORDINARY 500.0 MG
LTD. (AFRICA) LTD-NO. 6 ERLANGSHAN DRY VIALS VIAL
SHANDONG PROVINCE
P.R. 256100
1389 NDA/MAL/H BHARAT ABACUS AMPHOTRE AMPHOTERIC 50MG BHARAT SERUMS AND INDIA PARENTERAL 1.0X1.0 7/1/2012
DP/2696 SERUMS AND PHARMA T IN B VACCINES LTD- PLOT NO. ORDINARY VIAL
VACCINES LTD (AFRICA) K-27 ADDITIONAL MIDC VIALS CARTON
LIMITED AMBERNATH (E ) 412 501
1390 NDA/MAL/H REGAL REGAL PHARMA LUCIN HYDROCORTI 1%W/W REGAL KENYA TOPICAL 1.0X15.0 7/1/1997
DP/2697 PHARMACEUT (U) LTD OINTMENT SONE PHARMACEUTICALS LTD- EXTERNAL G TUBE
ICALS LTD BABA DOGO ROAD, OINTMENTS
1391 NDA/MAL/H CADILA ABACUS CARVIL 12.5 CARVEDILOL 12.5 MG CADILA HEALTHCARE INDIA ORAL SOLID 10.0X10.0 7/1/2005
DP/2699 HEALTHCARE PHARMA LIMITED--KUNDAIM ORDINARY TABLET
LTD (AFRICA) INDUSTRIAL ESTATE, PLOT FILM- BLISTER
INDIA
1392 NDA/MAL/H CADILA ABACUS EUGLIM 2 GLIMEPIRIDE 2MG CADILA HEALTH CARE LTD- INDIA ORAL SOLID 1.0X10.0X 7/1/2004
DP/2702 HEALTH CARE PHARMA KUNDAIM INDUSTRIAL ORDINARY 10.0
LIMITED (AFRICA) ESTATE, PLOT NO. 203- TABLETS TABLET
LIMITED 213, KUNDAIM,GOA-403 STRIP
115, INDIA
1393 NDA/MAL/H MACLEODS ROYAL PHARMA PRIMACOR HYDROCORTI 100MG MACLEODS INDIA PARENTERAL 1.0X1.0X1 7/1/2005
DP/2704 PHARMACEUT 2011 LIMITED T-100 SONE PHARMACEUTICALS LTD- ORDINARY 00.0 MG
ICALS LTD SODIUM MAHIM ROAD, NEAR DRY VIALS VIAL
SUCCINATE KULDEEP NAGAR
REGAR(W0
MAHARASHTRA
1394 NDA/MAL/H ASTRAZENEC MACNAUGHTON PULMICORT BUDESONIDE 0.5MG/ML ASTRA ZENECA SWEDEN SWEDEN LUNG 1.0X4.0X5 7/1/2011
DP/2705 A LIMITED NEBULISER OPERATIONS LIQUID ADMINISTRA .0X2.0 ML
PRODUCTION - TION LIQUID VIAL
KVARNBERGAGATANLZ SE- FOR
151-85,SWEDEN INHALATION
1395 NDA/MAL/H SOLVAY HARLEYS DUSPATALI MEBEVERINE 135MG SOLVAY NETHERLAND ORAL SOLID 1.0X10.0X 7/1/2008
DP/2706 PHARMACEUT UGANDA N HCL PHARMACEUTICALS PV- S ORDINARY 5.0
ICALS BV LIMITED VEERVEG 12 8121 AA 0187 TABLETS TABLET
NETHERLAND BLISTER
1396 NDA/MAL/H KAMPALA KAMPALA KAMCLOXA CLOXACILLIN 250MG KAMPALA UGANDA ORAL SOLID 100.0 7/1/1997
DP/2707 PHARMACEUT PHARMACEUTIC PHARMACEUTICAL ORDINARY CAPSULE
ICAL AL INDUSTRIES INDUSTRIES (1996) LTD- CAPSULES CONTAIN
INDUSTRIES 1996 LIMITED PLOT M 444B STRETCHER ER,250.0
(1996) LTD ROAD NTINDA CAPSULE
CONTAIN
ER,500.0
CAPSULE
CONTAIN
ER,1000.0
CAPSULE
CONTAIN
1397 NDA/MAL/H MACK SHURIK LTD HYPER PROPRANOLO 40MG TORQUE INDIA ORAL SOLID 1.0X1000. 7/1/2000
DP/2708 BROWN TABLETS L PHARMACEUTICALS LTD- ORDINARY 0 TABLET
PHARMECEUT HYDROCHLOR ISSAPUR P.O DAPPAR TABLETS CONTAIN
ICALS PVT LTD IDE 140506 ER,1.0X2.
0X50.0
TABLET
BLISTER
1398 NDA/MAL/H GLAXOSMITH UNITED AUGMENTI AMOXICILLIN 500 MG + SMITHKLINE BEECHAM UNITED ORAL SOLID 1.0X14.0 7/1/1997
DP/2710 KLINE HEALTHCARE N BD + 125 MG PHARMACEUTICALS,- KINGDOM ORDINARY TABLET
PHARMACEUT DISTRIBUTORS CLAVULANIC CLARENDON ROAD, TABLETS BLISTER
LTD SUSSEX, BN148QH
1399 NDA/MAL/H NEON AIVEEN (U) ANAWIN BUPIVACAINE 0.025%W/ NEON LABORATORIES LTD- INDIA PARENTERAL 1.0X20.0 7/1/2014
DP/2712 LABARATORIE LIMITED V PLOT NO. 29-32, 57 & 60, ORDINARY ML VIAL
S LTD PALGHAR TALUKA CO- VIALS
OPERATIVE ESTATE ,
BOISAR ROAD
1400 NDA/MAL/H NOVARTIS SURGIPHARM ANAFRANIL CLOMIPRAMI 25MG NOVARTIS PHARMA SPA, ITALY ORAL SOLID 1.0X30.0 7/1/1997
DP/2714 PHARMA AG (U) LIMITED NE TORRE ANNUNZIATA ORDINARY TABLET
ITALY-NA TABLETS CONTAIN
ER
1401 NDA/MAL/H MYLAN KIMSY MEDS LAMIVUDIN LAMIVUDINE 150MG MYLAN LABORATORIES INDIA ORAL SOLID 1.0X1.0X6 7/1/2008
DP/2715 LABORATORIE LTD E LTD--F-4,F-12 MALEGAON ORDINARY 0.0
S LIMITED MIDC SINNAR NASHIK TABLETS TABLET
422113 MAHARASHTRA CONTAIN
STATE ER
1402 NDA/MAL/H CENTAUR GITTOES OCUMYCIN CHLORAMPH 1%W/W CENTAUR PHARMA PVT. INDIA OPHTHALMI 1.0X3.5 G 7/1/2000
DP/2717 PHARMACEUT PHARMACEUTIC EYE ENICOL LTD-PLOT 39-41, TIVIM C TUBE
ICALS ALS LIMITED OINTMENT INDUSTRIAL ESTATE, OINTMENTS
PRIVATE KARASWADA, MAPUSA
LIMITED GOA INDIA
1403 NDA/MAL/H SHAIGAN HEALTHCARE GYNOMIN Z Z SHAIGAN PAKISTAN ORAL SOLID 1.0X2.0 7/1/1997
DP/2718 PHARMACEUT LTD. PHARMACEUTICALS (PVT) ORDINARY TABLET
ICALS LTD LIMITED-14 KM ADYALA TABLETS BLISTER
RD, RAWALPINDI,
PAKISTAN
1404 NDA/MAL/H SEDICO WIDE FLUCAMOX AMOXICILLIN 125MG/5 SEDICO PHARMACEUTICAL EGYPT ORAL LIQUID 1.0X80.0 7/1/2007
DP/2720 PHARMACEUT SPECTRUM 250MG +FLUCLOXACI ML+125M CO.-1ST INDUSTRIAL ZONE ORDINARY ML
ICAL CO. ENTERPRISES POWDER LLIN G/5ML 6 TH OCTOBER CITY DRY BOTTLE
(U) LIMITED FOR ORAL GIZA,EGYPT SUSPENSION
SUSPENSIO S/SYRUPS/D
N ROPS
1405 NDA/MAL/H MACK SHURIK LTD PRIMAFEN IBUPROFEN + 400MG + TORQUE INDIA ORAL SOLID 1.0X10.0X 7/1/2007
DP/2721 BROWN TABLET PARACETAM 325MG PHARMACEUTICALS LTD- ORDINARY 10.0
PHARMECEUT OL ISSAPUR P.O DAPPAR TABLETS TABLET
ICALS PVT LTD 140506 BLISTER
1406 NDA/MAL/H MACK SHURIK LTD NO SORES CHOLINE 8.7%W/W+ TORQUE INDIA ORAL 1.0X10.0 7/1/2007
DP/2722 BROWN SALICYLATE/L 2%W/W PHARMACEUTICALS LTD- TOPICAL G TUBE
PHARMACEUT IDOCAINE ISSAPUR P.O DAPPAR GELS AND
ICALS PVT 140506 SOLS
LIMITED
1407 NDA/MAL/H MISSION JOINT MEDICAL TRICLOVER MEDROXYPR 150MG/ML PT TUNGGAI IDAMAN INDONESIA PARENTERAL 1.0X20.0X 7/1/2010
DP/2730 PHARMA A/S STORE (UPMB - A OGESTERONE ABDI,-J1.JEND.YANI NO.7 ORDINARY I 1.0 ML
INDIA UCMB) ACETATE JAKARTA TIMUR M VIALS VIAL
1408 NDA/MAL/H DAR AL DAWA GAMA AMLODAR- AMLODIPINE 10MG DAR AL DAWA-NA'UR JORDAN ORAL SOLID 1.0X2.0X1 7/1/2009
DP/2734 DEVELOPMEN PHARMACEUTIC 10 BESILATE PLANT AMMAN ORDINARY 4.0
T AND ALS (U) LIMITED CAPSULES CAPSULE
INVESTMENT BLISTER
CO LTD
1409 NDA/MAL/H SHAIGAN HEALTHCARE SENEX SECNIDAZOLE 1G SHAIGAN PAKISTAN ORAL SOLID 1.0X1.0X2 7/1/2004
DP/2737 PHARMACEUT LTD. FORTE PHARMACEUTICALS (PVT) ORDINARY .0 TABLET
ICALS LTD LTD-14TH KM, ADYALA TABLETS BLISTER
ROAD, RAWALPINDI-
PAKISTAN
1410 NDA/MAL/H WIN- SURGIPHARM HEPA-MERZ L-ORNITHINE- 5MG/ML WIN-MEDICARE PRIVATE INDIA PARENTERAL 1.0X5.0X1 7/1/2001
DP/2738 MEDICARE (U) LIMITED INFUSION L-ASPARTATE LIMITED-MEERUT- ORDINARY I 0.0 ML
LTD MUZAFFARNAGAR ROAD, V VIALS VIAL
MODIPURAM - 250110
UTTAR PRADESH
1411 NDA/MAL/H REGAL REGAL PHARMA BISPANOL HYOSCINE 10MG REGAL KENYA ORAL SOLID 1.0X1000. 7/1/2001
DP/2739 PHARMACEUI (U) LTD TABLET BUTYLBROMI PHARMACEUTICALS LTD- ORDINARY 0 TABLET
CALS LTD DE BABA DOGO ROAD, FILM- CONTAIN
RAURAKA,NAIROBI,KENYA COATED ER,1.0X10
TABLETS .0X10.0
TABLET
BLISTER,1.
0X100.0X1
0.0
TABLET
BLISTER
1412 NDA/MAL/H AMANTA PHARMA VILLE STERILIZED STERILIZED MULTI- MARCK BIOSCIENCES INDIA PARENTERAL 1.0X10.0X
DP/2742 HEALTHCARE LIMITED WATER FOR WATER FOR INGREDIEN LIMITED. .-PLOT 876, NH ORDINARY 5.0X10.0
LTD INJECTION INJECTION BP T NO. 8, HARIYALA, KHEDA- INFUSION ML
BP 387411, GUJARAT VIALS/BOTTL BOTTLE
ES
1413 NDA/MAL/H BEIJING SUPER DUO- DIHYDROART 40MG + KBN- ZHEJIANG CHINA ORAL SOLID 1.0X1.0X9 7/1/2005
DP/2743 HOLLEY PHARMACEUTIC COTECXIN EMISININ + 320MG PHARMACEUTICAL CO. ORDINARY .0 TABLET
COTEC ALS LIMITED PIPERAQUINE LTD-NO. 340 YUNHAI FILM- BLISTER,1.
PHARMA PHOSPHATE ROAD JIAXING ECONOMIC COATED 0X1.0X4.0
CHINA DEVELOPMENT ZONE, TABLETS TABLET
JIAXING CITY, ZHEJIANG BLISTER,1.
PROVINCE 0X30.0X9.
0 TABLET
BLISTER
1414 NDA/MAL/H RENE RENE RENFORMI METFORMIN 500MG RENE INDUSTRIES LTD- UGANDA ORAL SOLID 1.0X10.0X 7/1/2015
DP/2745 INDUSTRIES INDUSTRIES N HYDROCHLOR PLOT 680, KAMULI ROAD, ORDINARY 10.0
LTD LIMITED IDE KIREKA, P.O BOX 6034, FILM- TABLET
KAMPALA COATED BLISTER
TABLETS
1415 NDA/MAL/H ERIS LTD BENLE CONSULT ACYCLOVIR ACYCLOVIR 200MG DENK PHARMA GMBH GERMANY ORAL SOLID 1.0X25.0 7/1/2000
DP/2746 LIMITED DENK 200 &CO.KG- ORDINARY TABLET
PRINZREGENTESTR.79.816 TABLETS BLISTER
75 MUENCHEN,
845529 TITTMONING
GERMANY
1416 NDA/MAL/H CADILA KARURI FLUDAC FLUOXETINE 20MG CADILA INDIA ORAL SOLID 1.0X20.0 7/1/1997
DP/2751 PHARMACEUT PHARMACEUTIC CAPSULES HCL PHARMACEUTICALS ORDINARY CAPSULE
ICALS ALS LTD. LIMITED-1389 DHOLKA CAPSULES BLISTER
387810 DISTRCT
AHMEDABAD GUJARAT
STATE
1417 NDA/MAL/H MACK SHURIK LTD PRASIL METOCLOPRA 10MG TORQUE INDIA ORAL SOLID 1.0X10.0X 7/1/2009
DP/2753 BROWN MIDE PHARMACEUTICALS LTD - ORDINARY 10.0
PHARMECEUT HYDROCHLOR ISSAPUR P.O DAPPAR TABLETS TABLET
ICALS PVT LTD IDE 140506 BLISTER
1418 NDA/MAL/H FDC LTD AIVEEN (U) ZATHRIN AZITHROMYCI 500MG FDC LIMITED -PLOT NO. INDIA ORAL SOLID 1.0X10.0X 7/1/2016
DP/2754 LIMITED 500 N DIHYDRATE L121 B PHASE 111A ORDINARY 1.0X3.0
VERNA INDUSTRIAL FILM- TABLET
ESTATE VERNA SALCETE COATED BLISTER,1.
GOA 403 722 TABLETS 0X50.0X1.
0X1.0X3.0
TABLET
BLISTER
1419 NDA/MAL/H PFIZER LABOREX CYTOTEC MISOPROSTO 200MCG PIRAMAL HEALTHCARE UNITED ORAL SOLID 1.0X2.0X1 7/1/2010
DP/2756 LABORATORIE UGANDA L LIMITED-WALTON ROAD KINGDOM ORDINARY 4.0
S LTD LIMITED MORPETH FILM- TABLET
NORTHUMBERLAND NE COATED BLISTER
613YA TABLETS
1420 NDA/MAL/H REGAL REGAL PHARMA DELASED DIPHENHYDR 14MG+6.5 REGAL KENYA ORAL LIQUID 1.0X100.0 7/1/1997
DP/2760 PHARMACEUT (U) LTD DRY AMINE MG+57MG PHARMACEUTICALS LTD- ORDINARY ML
ICALS LTD COUGH HYDROCHLOR +2MG BABA DOGO ROAD, SYRUPS BOTTLE
SYRUP IDE+DEXTRO RAURAKA,NAIROBI,KENYA
METHORPHA
N+SODIUM
CITRATE+ME
NTHOL
1421 NDA/MAL/H CADILA KARURI HAEM F FOLICACID+ 1MG+5MC CADILA INDIA ORAL LIQUID 1.0X200.0 7/1/2004
DP/2765 PHARMACEUT PHARMACEUTIC VITAMIN G+200MG/ PHARMACEUTICALS ORDINARY ML
ICALS ALS LTD. B12+IRON 15ML LIMITED-1389, TRASAD SYRUPS BOTTLE
AMMONIUM ROAD, DHOLKA- 382225,
CITRATE DIST: AHMEDAD, GUJARAT
STATE, INDIA
1422 NDA/MAL/H MISSION JOINT MEDICAL PHENOXYM PHENOXYME 250MG MEDICAMEN BIOTECH LTD- INDIA ORAL SOLID 1.0X1000. 7/1/2010
DP/2767 PHARMA A/S STORE (UPMB - ETHYLPENI THYLPENICILL SP-1192, A &B, PHASE –IV, ORDINARY 0 TABLET
INDIA UCMB) CILLIN IN INDUSTRIAL AREA TABLETS CONTAIN
TABLETS BP BHIWADI -301019 DIST. ER
ALWAR (RAJASTHAN)
1423 NDA/MAL/H REGAL REGAL PHARMA BISPANOL HYOSCINE-N- 5MG/5ML REGAL KENYA ORAL LIQUID 1.0X1.0X6 7/1/2004
DP/2773 PHARMACEUI (U) LTD ELIXIR BUTYLBROMI PHARMACEUTICALS LTD- ORDINARY 0.0 ML
CALS LTD DE BABA DOGO ROAD, SYRUPS BOTTLE,1.
RAURAKA, NAIROBI, 0X1.0X100
KENYA .0 ML
BOTTLE
1424 NDA/MAL/H ACINO GOODMAN BACTIFLOX CIPROFLOXAC 500MG ACINO PHARMA AG.- SWITZERLAN ORAL SOLID 1.0X10.0 7/1/2005
DP/2774 PHARMA AG INTERNATIONAL NEO 500 IN DORNACHERSTRASSE 114, D ORDINARY TABLET
LTD CH-4147 AESCH, FILM- BLISTER
SWITZERLAND COATED
TABLETS
1425 NDA/MAL/H UNIQUE TATA UGANDA TENSIMIN- ATENOLOL 100MG UNIQUE INDIA ORAL SOLID 10.0X10.0 7/1/1997
DP/2776 PHARMACEUT LIMITED 100 PHARMACEUTICAL ORDINARY TABLET
ICALS LABORATORIES (A DIV. OF TABLETS BLISTER,1.
LABORATORIE J.B CHEMICALS & 0X1000.0
S PHARMACEUTICALS LTD)- TABLET
216-219 GIDC INDUSTRIAL CONTAIN
AREA PANOLI 394 116 ER,14.0X1
DIST BHARUCH 0.0
TABLET
BLISTER
1426 NDA/MAL/H BROOKES HARLEYS PYODINE POVIDONE 7.5%W/V BROOKES PAKISTAN TOPICAL 1.0X60.0 7/1/2006
DP/2779 PHARMACEUT UGANDA SURGICAL IODINE PHARMACEUTICALS EXTERNAL ML
ICAL LIMITED SCRUB LABORATORIES LIQUIDS BOTTLE,1.
LABORATORIE (PAKISTAN) LTD-PLOT 58 0X450.0
SL SECTOR 15 KORANGI ML
INDUSTRIAL AREA, BOTTLE,1.
KARACHI-PAKISTAN 0X500.0
ML
BOTTLE
1427 NDA/MAL/H INTAS NORVIK CARVETAS CARVEDILOL 6.25MG INTAS PHARMACEUTICALS INDIA ORAL SOLID 1.0X3.0X1 7/1/2011
DP/2781 PHARMACEUT ENTERPRISES 6.25 LIMITED(BIOPHARMA ORDINARY 0.0
DEHRADUN
(UTTARAKHAND) INDIA
1428 NDA/MAL/H INTAS NORVIK KWINIL QUININE 300MG/ML INTAS PHARMACEUTICALS INDIA PARENTERAL 20.0X5.0X 7/1/1998
DP/2782 PHARMACEUT ENTERPRISES DIHYDROCHL LTD .-PLOT NOS. 457, 458 ORDINARY 2.0 ML
ICALS LTD LIMITED ORIDE & 191/218P SARKHEJ- AMPOULES AMPOULE
BAVLA HIGHWAY
MATODA SANAND
AHMEDABAD GUJARAT
1429 NDA/MAL/H MISSION JOINT MEDICAL AMOXICILLI AMOXICILLIN 125MG/5 MEDICAMEN BIOTECH LTD- INDIA ORAL LIQUID 1.0X100.0 7/1/2009
DP/2784 PHARMA A/S STORE (UPMB - N ORAL ML SP-1192, A &B, PHASE –IV, ORDINARY ML
UCMB) SUSPENSIO INDUSTRIAL AREA SUSPENSION BOTTLE
N BHIWADI -301019 DIST. S
ALWAR (RAJASTHAN)
1430 NDA/MAL/H RENE RENE MULTIVITA MULTIINGRE N/A RENE INDUSTRIES LIMITED- UGANDA ORAL SOLID 1.0X1000. 7/1/2010
DP/2788 INDUSTRIES INDUSTRIES MIN DIENT PLOT 680, KAMULI ROAD, ORDINARY 0 TABLET
LIMITED LIMITED TABLETS KIREKA TABLETS CONTAIN
ER
1431 NDA/MAL/H UNICHEM EUROPA TG-TOR 20 ATORVASTATI 20MG UNICHEM LABORATORIES INDIA ORAL SOLID 1.0X10.0 7/1/2003
DP/2790 LABORATORIE HEALTHCARE N LIMITED UNIT II-VILLAGE ORDINARY TABLET
S LIMITED√ (U) LTD BHATAULI KALAN BADDI TABLETS BLISTER
DIST SOLAN HIMACHAL
PRADESH 173 205
1432 NDA/MAL/H UNICHEM EUROPA TG-TOR 10 ATORVASTATI 10MG UNICHEM LABORATORIES INDIA ORAL SOLID 1.0X10.0 7/1/2003
DP/2792 LABORATORIE HEALTHCARE N LIMITED UNIT II-VILLAGE ORDINARY TABLET
S LIMITED√ (U) LTD BHATAULI KALAN BADDI FILM- BLISTER
DIST SOLAN HIMACHAL COATED
PRADESH 173 205 TABLETS
1433 NDA/MAL/H GILEAD MEDICAL VIREAD TENOFOVIR 300MG PATHEON YM INC. CANADA ORAL SOLID 1.0X1.0X3 7/1/2004
DP/2793 SCIENCE INC ACCESS DISOPROXIL TORONTO- TORONTO, ORDINARY 0.0
(UGANDA) FUMARATE CANADA ASPEN TABLETS TABLET
LIMITED PHARMACARE-7 BOTTLE
FAIRCLOUGH ROAD
KORSTEN PORT
ELIZABETH, 6020 SOUTH
AFRICA TAKEDA
GMBH,PLANT
ORANIENBURG-
LEHNITZSTRASSE 70-
98,16515,ORANIENBURG-
1434 NDA/MAL/H ASTRA ASTRA PHARMA BENZYLPEN BENZYLPENIC 1,000,000I. CSPC ZHONGNUO CHINA PARENTERAL 1.0X10.0 7/1/2001
DP/2796 PHARMA (UK) (U) LIMITED ICILLIN ILLIN SODIUM U PHARMACEUTICAL ORDINARY VIAL
LTD INJECTION (SHIJIAZHUANG)CO. LTD- DRY VIALS CARTON,1
NO. 88, YANGZI ROAD, .0X50.0
SHIJIAZHUANG CITY, VIAL
HEBEI CARTON
PROVINCE(WORKSHOP
406 AND 407)
1435 NDA/MAL/H RENE RENE LUMAREN ARTEMETHER 20 MG + RENE INDUSTRIES LTD- UGANDA ORAL SOLID 1.0X3.0X8 7/1/2010
DP/2797 INDUSTRIES INDUSTRIES + 120 MG PLOT 680, KAMULI ROAD, ORDINARY .0 TABLET
LTD LIMITED LUMEFANTRI KIREKA, P.O BOX 6034, TABLETS BLISTER
NE KAMPALA
1436 NDA/MAL/H NOVO STAR ACTRAPID HUMAN 100 I.U/ML NOVO NORDISK PHARMA- DENMARK PARENTERAL 1.0X1.5 7/1/1997
DP/2800 NORDISK PHARMACEUTIC HM INSULIN NOVO ALLE ORDINARY ML
ALS LTD PENFILL PRE-FILLED PREFILLED
PENS PEN,1.0X3
.0 ML
PREFILLED
PEN
1437 NDA/MAL/H CENTAUR GITTOES TASOL CLOBETASOL 0.05%W/W CENTAUR INDIA TOPICAL 1.0X15.0 7/1/2005
DP/2802 PHARMACEUT PHARMACEUTIC PHARMACEUTICALS PVT EXTERNAL G TUBE
ICALS ALS LIMITED LTD --PLANT II PLOT 39-41 CREAMS
PRIVATE TIVIM INDUSTRIAL ESTATE
GOA 403 526
1438 NDA/MAL/H REMEDICA GOODMAN NIFELAT NIFEDIPINE 20MG REMEDICA LIMITED - CYPRUS ORAL SOLID 1.0X3.0X1 7/1/1997
DP/2805 LTD INTERNATIONAL 20R AHARNON STREET, ORDINARY 0.0
LTD TABLETS LIMASSOL INDUSTRIAL TABLETS TABLET
ESTATE. LIMASSOL, BLISTER,1.
CYPRUS 3056, CYPRUS 0X10.0X10
.0 TABLET
BLISTER
1439 NDA/MAL/H GUILIN STAR ASAQ GPSC ARTESUNATE 100 MG + GUILIN CHINA ORAL SOLID 1.0X20.0X 7/1/2011
DP/2807 PHARMACEUT PHARMACEUTIC + 270 MG PHARMACEUTICALS CO. ORDINARY 3.0
ICALS CO.LTD ALS LTD AMODIAQUIN LTD-NO 43 SHANGHAI TABLETS TABLET
E ROAD GUILIN GUANGXI BLISTER,1.
CHINA 0X20.0X6.
0 TABLET
BLISTER,1.
0X25.0X3.
0 TABLET
BLISTER,1.
0X25.0X6.
0 TABLET
1440 NDA/MAL/H REGAL REGAL PHARMA SULPHUR SULPHUR 10%W/W REGAL KENYA TOPICAL 1.0X25.0 7/1/2001
DP/2811 PHARMACEUI (U) LTD OINTMENT PRECIPITATE PHARMACEUTICALS LTD- EXTERNAL G TUBE
CALS LTD D BABA DOGO ROAD, OINTMENTS
1441 NDA/MAL/H DAFRA LABOREX CO- BETA 180 MANUFACTURING NETHERLAND ORAL LIQUID 1.0X60.0 7/1/2005
DP/2812 PHARMA LTD UGANDA ARTESIANE ARTEMETHER MG/60ML PACKAGING FARMACIA S ORDINARY ML
LIMITED + + 1080 APPELHOF OUDEHASK- DRY BOTTLE
LUMEFANTRI MG/60ML NETHERLANDS SUSPENSION
NE S/SYRUPS/D
ROPS
1442 NDA/MAL/H REGAL REGAL PHARMA INTACYCLIN TETRACYCLIN 3%W/W REGAL KENYA TOPICAL 1.0X15.0 7/1/1997
DP/2813 PHARMACEUT (U) LTD E SKIN E PHARMACEUTICALS LTD- EXTERNAL G TUBE
ICALS LTD OINTMENT HYDROCHLOR BABA DOGO ROAD, OINTMENTS
IDE RAURAKA,NAIROBI,KENYA
1443 NDA/MAL/H THE ARAB GOODMAN VENTAL SALBUTAMOL 0.1MG + THE ARAB DRUG EGYPT LUNG 1.0X200.0 7/1/2014
DP/2814 DRUG INTERNATIONAL PLUS + 0.05MG/ COMPANY-5-EL MASSANEI ADMINISTRA DOSE
COMPANY LTD BECLOMETHA PUFF ST AL AMEREYA CAIRO TION CANNISTE
SONE METERED- R
DIPROPIONAT DOSE
E INHALER
1444 NDA/MAL/H CADILA ABACUS CATENOL- ATENOLOL 100MG CADILA HEALTHCARE INDIA ORAL SOLID 10.0X10.0 7/1/1997
DP/2816 HEALTH CARE PHARMA 100 LIMITED--KUNDAIM ORDINARY TABLET
LIMITED (AFRICA) TABLETS INDUSTRIAL ESTATE, PLOT TABLETS BLISTER
LIMITED NO. 203-213,
KUNDAIM,GOA-403 115,
INDIA
1445 NDA/MAL/H LINCOLN METRO DIOLIN-M GLIBENCLAMI 5MG+500 LINCOLN INDIA ORAL SOLID 1.0X10.0X 7/1/2011
DP/2821 PHARMACEUT PHARMACEUTIC DE+METFOR MG PHARMACEUTICAL ORDINARY 10.0
ICALS LTD ALS LIMITED MIN LIMITED..-LINCOLN TABLETS TABLET
HYDROCHLOR PHARMACEUTICALS STRIP
IDE TABLETS LIMITED, TRIMUL ESTATE,
KHATRAJ, TAL. KALOL,
DIST. GANDHINAGAR
1446 NDA/MAL/H GLAXO SMITH UNITED PIRITON CHLORPHENI 4MG/10ML GLAXOSMITHKLINE- KENYA ORAL LIQUID 1.0X100.0 7/1/1997
DP/2826 KLINE LTD HEALTHCARE SYRUP RAMINE LIKONI ROAD IND. AREA, ORDINARY ML
DISTRIBUTORS MALEATE NAIROBI SYRUPS BOTTLE,1.
LTD 0X2.0 L
BOTTLE
1447 NDA/MAL/H CADILA ABACUS R-LOC RANITIDINE 25MG/ML CADILA HEALTHCARE LTD INDIA PARENTERAL 1.0X5.0X2 7/1/2010
DP/2827 HEALTH CARE PHARMA SARKHEJ-BAVLA NH NO.8A ORDINARY .0 ML
LIMITED (AFRICA) MORAIYA TAL SANAND AMPOULES AMPOULE
LIMITED DISTRICT AHMEDABAD
382210
1448 NDA/MAL/H MEDIPHARM MEDIPHARM QUINIMIX QUININE 100MG/5 MEDIPHARM INDUSTRIES UGANDA ORAL LIQUID 1.0X100.0 7/1/2003
DP/2830 SALES INDUSTRIES MIXTURE HYDROCHLOR ML (E.A) LTD-PLOT 65, ORDINARY ML
LIMITED (E.A) LTD IDE KAKAJJO ROAD LIQUIDS BOTTLE
(BWEYOGERERE)
1449 NDA/MAL/H LINCOLN METRO SOLUDINE- POVIDONE 5%W/W / LINCOLN INDIA TOPICAL 1.0X20.0 7/1/2011
DP/2835 PHARMACEUT PHARMACEUTIC M IODINE / 1%W/W PHARMACEUTICALS EXTERNAL G
ICALS LTD ALS LIMITED METRONIDAZ LIMITED-10, 12, 13, OINTMENTS TUBE,1.0X
OLE TRIMUL ESTATE, AFTER 125.0 G
VADSCAR VILLAGE, NEAR TUBE
KHATRAJ CHOKADI,
KHATRAJ-382721,
GHANDHINAGAR,
GUJARAT, INDIA
1450 NDA/MAL/H MODI MUNDI SURGIPHARM DILCONTIN CONTROLLED 120MG MODI MUNDIPHARMA INDIA ORAL SOLID 1.0X10.0X 7/1/2010
DP/2838 PHARMA PVT (U) LIMITED XL 120 RELEASE (PVT) LTD-MEERUT - RETARD 10.0
LTD TABLETS OF MUZAFFARNAGAR ROAD, FILM- TABLET
DILTIAZEM MODIPURAM, UTTAR COATED STRIP
HYDROCHLOR PRADESH ESTATE TABLETS
IDE
1451 NDA/MAL/H MSD (PTY) PHILLIPS DIPROGENT BETAMETHAS 0.5MG/G+ SCHERING-PLOUGH CANADA TOPICAL 1.0X15.0 7/1/2001
DP/2848 LIMITED SA PHARMACEUTIC A ONE 1.0MG/G LABONV-INDUSTRIE PARK EXTERNAL G
ALS (UGANDA) OINTMENT /GENTAMICI 30, B-220 HEIST-OP-DEN- OINTMENTS TUBE,1.0X
LIMITED N SULPHATE BERG, BELGIUM 30.0 G
TUBE
1452 NDA/MAL/H MEDICAL KARURI DISPERCAM PIROXICAM 20MG MEDICAL UNION EGYPT PARENTERAL 1.0X2.0X3 7/1/2007
DP/2850 UNION PHARMACEUTIC PHARMACEUTICALS-36 DR ORDINARY .0X1.0 ML
PHARMACEUT ALS LTD. MOHAMED HASSAN EL- AMPOULES AMPOULE
ICALS GAMAL ST.6TH DISTRICT
NASR CITY EGYPT
1453 NDA/MAL/H SERUM NORVIK SII RABIVAX RABIES 2.5I.U/ML SERUM INSTITUTE OF INDIA PARENTERAL 1.0X1.0 7/1/2005
DP/2867 INSTITUTE OF ENTERPRISES VACCINE INDIA LTD-212/2 ORDINARY ML
INDIA LTD. LIMITED HADAPSAR, PUNE, 411028, AMPOULES AMPOULE
INDIA
1454 NDA/MAL/H CADILA ABACUS LOSACAR LOSARTAN 50MG CADILA HEALTH CARE LTD- INDIA ORAL SOLID 1.0X10.0X 7/1/2003
DP/2868 HEALTHCARE PHARMA 50 POTASSIUM KUNDAIM INDUSTRIAL ORDINARY 10.0
115, INDIA 0X10.0X7.
0 TABLET
BLISTER
1455 NDA/MAL/H GLAXO UNITED PRIORIX MEASLES + 103.0CCID GLAXO SMITHKLINE BELGIUM PARENTERAL 1.0X0.5 7/1/2010
DP/2869 SMITHKLINE HEALTHCARE VACCINE MUMPS + 50 + BIOLOGICALS S.A-RUE DE ORDINARY ML VIAL
LTD DISTRIBUTORS RUBELLA 103.7CCID L'INSTITUT, 89 B-1330 DRY VIALS (1 DOSE)
LTD 50 + RIXENSART
103.0CCID
50
1456 NDA/MAL/H INTAS NORVIK HELIGO KIT TINIDAZOLE/ 500MG+ INTAS PHARMACEUTICALS INDIA ORAL SOLID 1.0X7.0X6 7/1/2001
DP/2873 PHARMACEUT ENTERPRISES CLARITHROM 250MG+30 LTD .-PLOT NOS. 457, 458 ORDINARY .0 TABLET
ICALS LTD LIMITED YCIN/LANSOP MG & 191/218P SARKHEJ- TABLETS BLISTER
RAZOLE BAVLA HIGHWAY
MATODA SANAND
AHMEDABAD GUJARAT
1457 NDA/MAL/H AMANTA PHARMA VILLE CANDICAN FLUCONAZOL 0.2%W/V MARCK PARENTERALS INDIA PARENTERAL 1.0X100.0 7/1/2005
DP/2877 HEALTHCARE LIMITED E (INDIA) LTD-PLOT NO. 876, ORDINARY ML
LTD N.H,NO.8,VIL, HANYALA, INFUSION BOTTLE
KHEDA 387411,GURAJAT, VIALS/BOTTL
INDIA ES
1458 NDA/MAL/H PHARCO WIDE FARCOCIN GENTAMYCIN 0.1%W/W PHARCO EGYPT TOPICAL 1.0X20.0 7/1/2000
DP/2878 PHARMACEUT SPECTRUM CREAM SULPHATE PHARMACEUTICALS LTD- EXTERNAL G TUBE
ICALS LTD ENTERPRISES KILO 31 ALEXANDRIA, CREAMS
ALEXANDRIA EGYPT
1459 NDA/MAL/H CADILA ABACUS OFLIN-200 OFLOXACIN 200MG CADILA HEALTHCARE INDIA ORAL SOLID 1.0X10.0X 7/1/2004
DP/2879 HEALTHCARE PHARMA LIMITED--KUNDAIM ORDINARY 20.0
LTD (AFRICA) INDUSTRIAL ESTATE, PLOT TABLETS TABLET
INDIA 0 TABLET
BLISTER,1.
0X10.0X10
.0 TABLET
BLISTER,1
0.0X1.0X1
0.0
1460 NDA/MAL/H REMEDICA GOODMAN CARBIMAZ CARBIMAZOL 5MG REMEDICA LIMITED,- CYPRUS ORAL SOLID 1.0X10.0X 7/1/2010
DP/2880 LTD INTERNATIONAL OLE 5 E LIMASSOL INDUSTRIAL ORDINARY 10.0
LTD ESTATE, AHARNON ST, TABLETS TABLET
P.O. BOX 51706,3508 BLISTER
LIMASSOL
1461 NDA/MAL/H TATA TATA UGANDA HYOSCINE HYOSCINE 2OMG/ML GLAND PHARMA LTD -D.P INDIA PARENTERAL 1.0X10.0X 7/1/2009
DP/2882 UGANDA LIMITED BROMIDE BROMIDE PALLY DUNDIGAL POST ORDINARY 1.0 ML
LIMITED QUTBULLAPUR MANDAL AMPOULES AMPOULE
RANGA REDDY DISTRICT
HYDERABAB 500043
GLAND PHARMA LTD-
PLOT NO. 42 TO 52, SY
NO. 166, 171, 172 & 177,
TSIIC, PHASE III,
PASHAMYLARAM (V)
PATANCHERU (M), MEDAK
DISTRICT 502307,
1462 NDA/MAL/H MACLEODS NORVIK FORECOX- RIFAMPICIN + 150MG + MACLEODS INDIA ORAL SOLID 1.0X10.0X 7/1/2005
DP/2885 PHARMACEUT ENTERPRISES TRAC ISONIAZID + 75MG+ PHARMACEUTICALS LTD .- ORDINARY 6.0
ICALS LTD LIMITED PYRAZINAMI 400MG + PLOT 25-27 SURVEY NO. TABLETS TABLET
DE + 275MG 366 PREMEIRE BLISTER,1.
ETHAMBUTO INDUSTRIAL ESTATE 0X24.0X28
L KACHIGAN DAMAN .0 TABLET
396210 INDIA OXALIS BLISTER
LABS LIMITED-VILLAGE
THEDA, P.O LODHIMAJRA,
TEHSIL,BADDI,
DIST.SOLAN, INDIA
1463 NDA/MAL/H MISSION JOINT MEDICAL QUININE QUININE 300MG MEDICAMEN BIOTECH LTD- INDIA ORAL SOLID 1.0X1000. 7/1/2009
DP/2887 PHARMA A/S STORE (UPMB - SULPHATE SULPHATE SP-1192, A &B, PHASE –IV, ORDINARY 0 TABLET
UCMB) INDUSTRIAL AREA FILM- CONTAIN
BHIWADI -301019 DIST. COATED ER
ALWAR (RAJASTHAN) TABLETS
1464 NDA/MAL/H VHB MEDI LLOYDS SUCCICORT HYDROCORTI 100MG/VI VHB MEDI SCIENCES LTD- INDIA PARENTERAL 1.0X100.0 7/1/2013
DP/2888 SCIENCES LTD PHARMACY SONE AL PLOT 20, 21, 22 & 49,50, ORDINARY MG VIAL
LIMITED SODIUM 51. INTEGRATED DRY VIALS
SUCCINATE INDUSTRIAL AREA SECTOR
5, RUDRAPUR,
UTTARAKHAND - INDIA
1465 NDA/MAL/H KPI KAMPALA BETASOL N BETAMETHAS 1MG/G+5 KPI INDUSTRIES (1996) UGANDA TOPICAL 1.0X15.0 7/1/2005
DP/2890 INDUSTRIES(1 PHARMACEUTIC ONE+NEOMY MG/G LTD-PLOT NO.M444B EXTERNAL G TUBE
996) LTED AL INDUSTRIES CIN STRETCHER RD, NTINDA, CREAMS
1996 LIMITED KAMPALA
1466 NDA/MAL/H MACLEODS NORVIK TORVAST ATORVASTATI 20MG MACLEODS INDIA ORAL SOLID 1.0X10.0 7/1/2006
DP/2891 PHARMACEUT ENTERPRISES 20 N PHARMACEUTICALS LTD .- ORDINARY TABLET
ICALS LTD LIMITED PLOT 25-27 SURVEY NO. TABLETS BLISTER
366 PREMEIRE
INDUSTRIAL ESTATE
KACHIGAN DAMAN
396210 INDIA
1467 NDA/MAL/H UNIQUE TATA UGANDA NICARDIA- NIFEDIPINE 20MG UNIQUE INDIA ORAL SOLID 1.0X5.0X1 7/1/1997
DP/2892 PHARMACEUT LIMITED 20 TABLETS PHARMACEUTICAL ORDINARY 0.0
ICAL LABORATORIES-PLOT NO. TABLETS TABLET
LABORATORIE 215-219, G.I.D.C. BLISTER,1.
S INDUSTRIAL AREA,PANOLI 0X10.0X10
— 394 116, GUJARAT, .0 TABLET
INDIA. BLISTER
1468 NDA/MAL/H DAWA SUPER MEDIC STOPACID MAGNESIUM 250MG/5 DAWA-PLOT 7879, BABA KENYA ORAL LIQUID 1.0X100.0 7/1/2009
DP/2893 LIMITED LTD SUSPENSIO TRISILICATE + ML + DOGO ROAD RUARAKA, ORDINARY ML
N ALUMINIUM 120MG/5 NAIROBI, KENYA SUSPENSION BOTTLE
HYDROXIDE ML S
1469 NDA/MAL/H EGYPTIAN WIDE MUCOGEL DRIED 8G/100ML EGYPIAN INTERNATIONAL EGYPT ORAL LIQUID 1.0X125.0 7/1/2005
DP/2894 INTERNATION SPECTRUM SUSPENSIO ALUMINIUM + PHARMACEUTICAL ORDINARY ML
AL ENTERPRISES N HYDROXIDE + 2G/100ML INDUSTRIES CO EIPICO- SUSPENSION BOTTLE
PHARMACEUT (U) LIMITED MAGNESSIU + 0.2 10TH OF RAMADAN CITY- S
ICAL M G/100ML FIRST INDUSTRIAL AREA -
INDUSTRIES HYDROXIDE + EGYPT
COMPANY OXETHAZAIN
E
1470 NDA/MAL/H KPI KAMPALA MCG MICONAZOLE 2.0%W/W KPI INDUSTRIES (1996) UGANDA TOPICAL 1.0X30.0 7/1/2005
DP/2896 INDUSTRIES(1 PHARMACEUTIC CREAM NITRATE BP + + LTD-PLOT NO.M444B EXTERNAL G
996) LTED AL INDUSTRIES CLOBETASOL 0.05%W/W STRETCHER RD, NTINDA, CREAMS TUBE,1.0X
1996 LIMITED PROPIONATE + 0.1 KAMPALA 15.0 G
BP + %W/W TUBE,1.0X
GENTAMYCIN 25.0 G
SULPHATE TUBE
1471 NDA/MAL/H MACLEODS NORVIK TORVAST ATORVASTATI 10MG MACLEODS INDIA ORAL SOLID 1.0X10.0 7/1/2006
DP/2898 PHARMACEUT ENTERPRISES 10 N PHARMACEUTICALS LTD .- ORDINARY TABLET
ICALS LTD LIMITED PLOT 25-27 SURVEY NO. TABLETS BLISTER
366 PREMEIRE
INDUSTRIAL ESTATE
KACHIGAN DAMAN
396210 INDIA
1472 NDA/MAL/H MICRO LABS LABOREX GRAMOCEF- CEFIXIME 200MG MICRO LABS LIMITED, INDIA ORAL SOLID 1.0X10.0 7/1/2005
DP/2900 LTD UGANDA O-200 BOMMASANDRA -PLOT ORDINARY CAPSULE
LIMITED NO. 121-124 4TH PHASE CAPSULES BLISTER
K.I.A.D.B BOMMASANDRA
INDUSTRIAL AREA ANEKAL
TALUK BANGALORE 560
099
1473 NDA/MAL/H MACLEODS NORVIK MEGALIS- TADALAFIL 20MG MACLEODS INDIA ORAL SOLID 1.0X15.0X 7/1/2005
DP/2902 PHARMACEUT ENTERPRISES 20 PHARMACEUTICALS ORDINARY 1.0X4.0
ICALS LTD LIMITED LIMITED (BLOCK –N1)- FILM- TABLET
VILLAGE THEDA, P.O. COATED STRIP
LODHI MAJRA,TEHSIL TABLETS
BADDI, HIMACHAL
PRADESH -174101,INDIA
1474 NDA/MAL/H EGYPTIAN WIDE BRONCHOP GUAIPHENESI 50MG+7.5 EGYPT INTERNATIONAL EGYPT ORAL LIQUID 1.0X1.0X1 7/1/2007
DP/2905 INTERNATION SPECTRUM HANE N+EPHEDRIN MG+5MG+ PHARMACEUTICAL ORDINARY 25.0 ML
AL ENTERPRISES SYRUP E 4.58MG INDUSTRIES CO. EIPICO- SYRUPS BOTTLE
PHARMACEUT (U) LIMITED HYDROCHLOR 10TH STREET RAMADAN
ICAL IDE+DIPHENH CITY, FIST INDUSTRIES ARE
INDUSTRIES YDRAMINE
COMPANY HYDROCHLOR
IDE+DEXTRO
METHORPHA
N
1475 NDA/MAL/H SHOSAAN RENE PAINGO METHYLSALIC 15%W/W + NEM LABORATORIES PVT INDIA TOPICAL 1.0X2.0X1 7/1/2010
DP/2908 ASIC PACIFIC PHARMACY LTD MEDICATED YLATE+CAPSI 1%W/W + LTD-133 VASAI RD(E) 401 EXTERNAL 5.0 G
CREAM CUM 1.47%W/W 162 SB MARG. LOWER CREAMS TUBE
OLEORESIN+T PAREL MUMBAI
URPENTINE
OIL
1476 NDA/MAL/H CIPLA LTD QUALITY TENVIR EM TENOFOVIR 300MG+20 CIPLA LTD.- -PLOT NO INDIA ORAL SOLID 1.0X30.0 7/1/2009
DP/2910 CHEMICALS LTD - DISOPROXIL 0MG L/139 TO L/146, VERNA ORDINARY TABLET
HUMAN FUMARATE + INDUSTRIAL ESTATE, FILM- BOTTLE
EMTRICITABI VERNA, SOUTH GOA COATED
NE DISTRICT, 403722 GOA TABLETS
1477 NDA/MAL/H KOTRA ABACUS AXCEL LORATADINE 10MG KOTRA PHARMA (M) SDN. MALAYSIA ORAL SOLID 1.0X10.0X 7/1/2010
DP/2911 PHARMA (M) PHARMA LORATADIN BHD-1 JALAN TTC 12, ORDINARY 10.0
SDN BHD (AFRICA) E CHENG INDUSTRIAL TABLETS TABLET
LIMITED ESTATE, 75250 MELAKA BLISTER
MALYSIA
1478 NDA/MAL/H FDC LTD AIVEEN (U) MYCODER SALICYLIC 3%W/W + FDC LIMITED -B-8, INDIA TOPICAL 1.0X100.0 7/1/2004
DP/2912 LIMITED M ACID + 6%W/W M.I.D.C., INDUSTRIAL EXTERNAL G
BENZOIC AREA, WALUJ – POWDERS CONTAIN
ACID AURANGABAD- 431 136 ER
MAHARASHTRA, INDIA.
1479 NDA/MAL/H REGAL REGAL PHARMA CHLOROCID CHLORAMPH 125MG/5 REGAL KENYA ORAL LIQUID 1.0X100.0 7/1/1997
DP/2914 PHARMACEUT (U) LTD E ENICOL ML PHARMACEUTICALS LTD- ORDINARY ML
ICALS LTD SUSPENSIO PALMITATE BABA DOGO ROAD, SUSPENSION BOTTLE
N RAURAKA,NAIROBI,KENYA S
1480 NDA/MAL/H REGAL REGAL PHARMA CETAMOL PARACETAM 500MG REGAL KENYA ORAL SOLID 1.0X50.0X 7/1/1997
DP/2917 PHARMACEUT (U) LTD TABLETS OL PHARMACEUTICALS LTD- ORDINARY 2.0
RAURAKA,NAIROBI,KENYA STRIP,1.0X
500.0
TABLET
CONTAIN
ER,1.0X10
00.0
TABLET
CONTAIN
ER,1.0X10
1481 NDA/MAL/H CADILA ABACUS ODIMONT 5 MONTELUKAS 5MG CADILA HEALTHCARE LTD-- INDIA ORAL SOLID 1.0X3.0X1 7/1/2011
DP/2919 HEALTHCARE PHARMA T -SARKHEJ-PLOT ORDINARY 0.0
LTD (AFRICA) 417,419,420, SARKHEJ- CHEWABLE TABLET
LIMITED BAVLA NH TABLETS BLISTER
NO.8A,VILLAGE: MORAIYA
TAL: SANAND DISTRICT
AHMEDABAD 382210
1482 NDA/MAL/H CENTAUR GITTOES TRANSLIPO - CLOTRIMAZO 1%W/W CENTAUR INDIA TOPICAL 1.0X15.0 7/1/2001
DP/2920 PHARMACEUT PHARMACEUTIC C CREAM LE PHARMACEUTICALS PVT EXTERNAL G
ICALS LTD ALS LIMITED LTD --PLANT II PLOT 39-41 CREAMS TUBE,1.0X
TIVIM INDUSTRIAL ESTATE 20.0 G
KARASWADA MAPUSA TUBE,1.0X
GOA 403 526 10.0 G
TUBE
1483 NDA/MAL/H CIRON DRUGS RENE COLD PLUS PARACETAM 125MG + CIRON DRUGS & INDIA ORAL LIQUID 1.0X100.0 7/1/2014
DP/2923 & PHARMACY LTD SYRUP OL + 2.5MG + PHARMACEUTICALS PVT ORDINARY ML
PHARMACEUT PHENYLEPHRI 2.5MG/ LTD--N-118, 119 MIDC SYRUPS BOTTLE
ICALS PVT LTD NE 5ML TARAPUR BOISAR DIST
HYDROCHLOR THANE 4011 506
IDE +
CHLORPHENI
RAMINE
MALEATE
1484 NDA/MAL/H ASTRA LIFE ASTRA PHARMA ASTOLON PREDNISOLO 5MG ASTRA LIFE CARE PVT LTD- INDIA ORAL SOLID 1.0X10.0X 7/1/2007
DP/2934 CARE PVT LTD (U) LIMITED NE 57/P RAJODA-382220 ORDINARY 10.0
BAVIA AHMEDABAD INDIA TABLETS TABLET
BLISTER,1.
0X1000.0
TABLET
CONTAIN
ER
1485 NDA/MAL/H ASTRA LIFE ASTRA PHARMA FEMIN-P NYSTATIN 100,000IU ASTRA LIFE CARE (INDIA) INDIA VAGINAL 1.0X15.0 7/1/2007
DP/2936 CARE (INDIA) (U) LIMITED PVT LTD-57/P,RAJODA TABLETS PESSARY
PVT LTD 382220, BAVLA BLISTER
AHMEDABAD INDIA
1486 NDA/MAL/H ASTRA LIFE ASTRA PHARMA ASTODIUM LOPERAMIDE 2MG ASTRA LIFECARE (INDIA) INDIA ORAL SOLID 1.0X10.0X 7/1/2007
DP/2939 CARE (INDIA) (U) LIMITED HYDROCHLOR PVT. LTD-PLOT 57/P, ORDINARY 10.0
PVT LTD IDE SARKHEJ-BAVLA OTHER CAPSULE
HIGHWAY, RAJODA 382 CAPSULES BLISTER
1487 NDA/MAL/H CENTAUR GITTOES BENZOX 5 BENZOYL 5%W/W CENTAUR INDIA TOPICAL 1.0X2.0 G 7/1/2005
DP/2940 PHARMACEUT PHARMACEUTIC GEL PEROXIDE PHARMACEUTICALS LTD- EXTERNAL TUBE
ICALS ALS LIMITED PLOT NO. 39 TIVIN IN OTHER
PRIVATE GELS/SOLS
LIMITED
1488 NDA/MAL/H CADILA ABACUS ATORVA 20 ATORVASTATI 20MG CADILA HEALTH CARE LTD- INDIA ORAL SOLID 1.0X3.0X1 7/1/2005
DP/2941 HEALTHCARE PHARMA N KUNDAIM INDUSTRIAL ORDINARY 0.0
115, INDIA 0X5.0X7.0
TABLET
BLISTER
1489 NDA/MAL/H CENTAUR GITTOES ARGISSEPT CHOLRHEXIDI 0.2%W/W CENTAUR INDIA TOPICAL 1.0X20.0 7/1/2005
DP/2942 PHARMACEUT PHARMACEUTIC CREAM NE / 1%W/W PHARMACEUTICALS PVT EXTERNAL G
ICALS ALS LIMITED GLUCONATE/ LTD --PLANT II PLOT 39-41 CREAMS TUBE,1.0X
PRIVATE SILVER TIVIM INDUSTRIAL ESTATE 10.0 G
LIMITED SULPHADIAZI KARASWADA MAPUSA TUBE
NE GOA 403 526
1490 NDA/MAL/H MEDLEY MEDVIN ONCET CETIRIZINE 10MG MEDLEY INDIA ORAL SOLID 1.0X10.0X 7/1/2005
DP/2945 PHARMACEUT PHARMA DIHYDROCHL PHARMACEUTICALS LTD- ORDINARY 10.0
ICALS LTD LIMITED ORIDE PLOT NO.18 AND 19, TABLETS TABLET
SURVEY NO.378/8 & BLISTER
ESTATE, KACHIGAM,
DAMAN-396210 INDIA
1491 NDA/MAL/H GITTOES GITTOES TRIMAGO CO- 240MG/5 AGOG PHARMA LTD-PLOT INDIA ORAL LIQUID 1.0X100.0 7/1/1998
DP/2946 PHARMACEUT PHARMACEUTIC ORAL TRIMOXAZOL ML NO.33,SECTOR ORDINARY ML
ICALS LIMITED ALS LIMITED SUSPENSIO E II,VASAI,TALUKA INDL CO- SUSPENSION BOTTLE,1.
N OP ESTATE LTD,GAURAI S 0X60.0 ML
E INDIA
1492 NDA/MAL/H GITTOES GITTOES TRIMAGO CO- 480MG AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1.0X100.0 7/1/1998
DP/2947 PHARMACEUT PHARMACEUTIC TABLETS TRIMOXAZOL NO.33,SECTOR ORDINARY X10.0
ICALS LIMITED ALS LIMITED E II,VASAI,TALUKA INDL CO- TABLETS TABLET
E INDIA TABLET
CONTAIN
ER,1.0X10
.0X10.0
TABLET
BLISTER,1.
0X1000.0
1493 NDA/MAL/H DENK BENLE CONSULT METFORMI METFORMIN 850MG DENK PHARMA GMBH GERMANY ORAL SOLID 1.0X1.0X1 7/1/2007
DP/2948 PHARMA LIMITED N DENK 850 HYDROCHLOR &CO.KG-- ORDINARY 5.0
GMBH & CO IDE PRINZREGENTESTR.79.816 FILM- TABLET
KG 75 MUENCHEN, COATED BLISTER,1.
GERMANY BLISTER
1494 NDA/MAL/H PFIZER LABOREX XALATAN LATANOPROS 0.005%W/ PFIZER MANUFACTURING - BELGIUM OPHTHALMI 1.0X2.5 7/1/1998
DP/2950 LABORATORIE UGANDA T V NV/NA, RIJKSWEG 12 C DROPS ML
S PTY LTD LIMITED 2870, PUURS BOTTLE
1495 NDA/MAL/H ARISTO NORVIK TRANLOK TRANEXAMIC 500MG ARISTO INDIA ORAL SOLID 1.0X10.0X 7/1/2007
DP/2956 PHARMACEUT ENTERPRISES 500MG ACID PHARMACEUTICALS PVT ORDINARY 10.0
ICALS PVT LTD LIMITED TABLETS LIMITED-PLOT 208, NEW TABLETS TABLET
INDUSTRIAL AREA NO II, BLISTER,1.
MANDIDEEP-462 046 0X3.0X10.
(DISTRICT) RAISEN, 0 TABLET
MADHYA PRADESH INDIA BLISTER
1496 NDA/MAL/H MEDIPHARM ABACUS MEDITROL CALCITRIOL 0.25MCG MEGA LIFE SCIENCES THAILAND ORAL SOLID 1.0X6.0X5 7/1/2009
DP/2957 SALES PHARMA LIMITED-: PLANT I : 384 ORDINARY .0
LIMITED (AFRICA) SOI 6, PATTANA 3 ROAD, CAPSULES CAPSULE
LIMITED BANGPOO INDUSTRIAL BLISTER,1.
ESTATE, SAMUTPRAKAN 0X3.0X10.
10280, THAILAND 0
CAPSULE
BLISTER
1497 NDA/MAL/H REGAL REGAL PHARMA CETAMOL PARACETAM 120MG/5 REGAL KENYA ORAL LIQUID 1.0X60.0 7/1/1997
DP/2959 PHARMACEUT (U) LTD SYRUP OL ML PHARMACEUTICALS LTD- ORDINARY ML
ICALS LTD BABA DOGO ROAD, SYRUPS BOTTLE,1.
ML
BOTTLE
1498 NDA/MAL/H DAR AL DAWA GAMA CLAVODAR AMOXICILLIN 400MG/57 DAR AL DAWA-NA'UR JORDAN ORAL SOLID 1.0X70.0 7/1/2010
DP/2960 DEVELOPMEN PHARMACEUTIC /CLAVULANIC MG PLANT AMMAN ORDINARY ML
T AND ALS (U) LIMITED ACID GRANULES BOTTLE
INVESTMENT
CO LTD
1499 NDA/MAL/H NORVATIS LABOREX OFTALMOL ERYTHROMYC 0.5%W/W ALCON CUSI SA-CAMIL SPAIN OPHTHALMI 1.0X3.5 G 7/1/2001
DP/2961 PHARMA AG- UGANDA OSA CUSI IN FABRA 58 08320 EL C TUBE
SWITZERLAN LIMITED ERYTHROM MASNOUR BARCELONA OINTMENTS
D YCIN 0.5%
1500 NDA/MAL/H CIPLA LTD QUALITY TENVIR TENOFOVIR 300MG CIPLA LTD.-VERNA IND. INDIA ORAL SOLID 1.0X30.0 7/1/2007
DP/2966 CHEMICALS LTD - DISOPROXIL ESTATE GOA 403 722 ORDINARY TABLET
HUMAN FUMARATE INDIA TABLETS BOTTLE
1501 NDA/MAL/H CADILA KARURI HAEM-F FERROUS 200MG CADILA INDIA ORAL SOLID 1.0X30.0 7/1/2003
DP/2967 PHARMACEUT PHARMACEUTIC FUMARATE PHARMACEUTICALS LTD.- ORDINARY CAPSULE
ICALS LIMITED ALS LTD. 1389, TRASAD ROAD, CAPSULES BOTTLE
DHOLKA 387810 DISTRICT
AHMEDABAD GUJARAT
STATE
1502 NDA/MAL/H UNIQUE TATA UGANDA TENSIMIN- ATENOLOL 50MG UNIQUE INDIA ORAL SOLID 10.0X10.0 7/1/1997
DP/2969 PHARMACEUT LIMITED 50 PHARMACEUTICAL ORDINARY TABLET
ICALS LTD LABORATORIES (A DIV. OF TABLETS BLISTER,1
J.B CHEMICALS & 4.0X10.0
PHARMACEUTICALS LTD)- TABLET
216-219 GIDC INDUSTRIAL BLISTER
AREA PANOLI 394 116
DIST BHARUCH
1503 NDA/MAL/H USV PRIVATE ABACUS GLYCOMET METFORMIN 500MG FREDUN INDIA ORAL SOLID 1.0X10.0X 7/1/2000
DP/2970 LIMITED PHARMA 500 PHARMACEUTICALS ORDINARY 10.0
(AFRICA) LIMITED---14,15,16 TABLETS TABLET
LIMITED ZORABIAN INDUSTRIAL BLISTER
COMPLEX PALAGHAR
404 INDIA
1504 NDA/MAL/H TORRENT KARURI LEFRA-20 LEFLUNOMID 20MG TORRENT INDIA ORAL SOLID 1.0X5.0X1 7/1/2004
DP/2971 PHARMACEUT PHARMACEUTIC TABLETS E PHARMACEUTICALS LTD- ORDINARY 0.0
ICALS LIMITED ALS LTD. INDRAD-382 721, TABLETS TABLET
DIST.MEHSANA,INDIA.AT: BLISTER
1505 NDA/MAL/H NORVATIS LABOREX TRAVATAN TRAVOPROST 4µG/ML ALCON COUVREUR NV- BELGIUM OPHTHALMI 1.0X2.5 7/1/2009
DP/2974 PHARMA AG- UGANDA RIJKSWEG 14, B-2870 C DROPS ML VIAL
SWITZERLAN LIMITED PUURS BELGIUM
D
1506 NDA/MAL/H SANOFI LABOREX TETAVAX TETANUS 40 I.U SANOFI PASTEUR-1541 FRANCE PARENTERAL 1.0X0.5 7/1/1997
DP/2978 PASTEUR UGANDA VACCINE AVENUE MARCEL ORDINARY ML PRE-
LIMITED MERIEUX, 69280 MARCY, PRE-FILLED FILLED
LETOILE SANOFI PASTEUR SYRINGES SYRINGE
S.A-2,AVENUE PONT (1 DOSE)
PASTEUR 69007 LYON-
FRANCE(BUSINESS
ADDRESS)
1507 NDA/MAL/H ROYAL ABACUS BETADERM BETAMETHAS 0.1%W/W ATCO LABORATORIES PVT PAKISTAN TOPICAL 1.0X5.0 G 7/1/1997
DP/2979 GROUP PHARMA N CREAM ONE + LTD-B-18,S.I.T.E KARACHI EXTERNAL TUBE,1.0X
(AFRICA) VALERATE + 0.5%W/W 75700, PAKISTAN CREAMS 15.0 G
LIMITED NEOMYCIN TUBE
1508 NDA/MAL/H CENTAUR GITTOES NEURO- VITAMIN B1 + 200MG + CENTAUR INDIA ORAL SOLID 1.0X2.0X1 7/1/2004
DP/2982 PHARMACEUT PHARMACEUTIC FORTE VITAMIN B6 + 50MG + PHARMACEUTICALS LTD- ORDINARY 0.0
ICALS PVT LTD ALS LIMITED TABLETS VITAMIN B12 1MG PLOT NO.3 TIVIN FILM- TABLET
INDUSTRIAL ESTATE COATED BLISTER
KARASWADA 403526 TABLETS
INDIA
1509 NDA/MAL/H CIPLA LTD. QUALITY FUCOL 200 FLUCONAZOL 200MG CIPLA LTD -PLOT NO. L- INDIA ORAL SOLID 1.0X5.0X1 7/1/2004
DP/2983 CHEMICALS LTD - E 139, VERNA, GOA 403 722 ORDINARY .0X4.0
HUMAN INDIA CIPLA LTD CAPSULES CAPSULE
KURKUMBH-D-7 MIDC BLISTER
INDUSTRIAL AREA,
KURKUMBH, TALUKA-
DAUND, PUNE,
MAHARASHTRA
1510 NDA/MAL/H SANOFI SURGIPHARM EPILIM SODIUM 500MG SANOFI WINTHROP FRANCE ORAL SOLID 1.0X10.0X 7/1/2004
DP/2985 WINTHROP (U) LIMITED CHRONO VALPROATE INDUSTRIE-1,RUE DE LA RETARD 10.0
LTD PH. EUR VIERGE ,AMBARES ET TABLETS TABLET
LAGRAVE 33565,CARBON BLISTER
BLANC CEDEX FRANCE
1511 NDA/MAL/H METRO METRO DICLOFENA DICLOFENAC 25MG/ML CSPC OUYI CHINA PARENTERAL 1.0X10.0X 7/1/2011
DP/2989 PHARMACEUT PHARMACEUTIC C PHARMACEUTICAL CO. ORDINARY 10.0X3.0
ICALS LIMITED ALS LIMITED LTD.-WORKSHOPS 112,113 AMPOULES ML
AND 117 PLOT NO. 88 AMPOULE
YANGZI ROAD,ECONOMIC
AND TECHNOLOGICAL
DEVELOPMENT ZONE,
SHIJIAZHUANG CITY,
HEBEI PROVINCE, CHINA
1512 NDA/MAL/H MICRO LABS LABOREX PULMOCEF- CEFUROXIME 500MG MICRO LABS LTD--NO. 121- INDIA ORAL SOLID 1.0X1.0X1 7/1/2004
DP/2990 LTD UGANDA 500 AXETIL USP 124 4TH PHASE K.I.A.D.B ORDINARY 0.0
LIMITED BOMMASANDRA FILM- TABLET
INDUSTRIAL AREA ANEKAL COATED BLISTER,1.
TALUK BANGALORE 560 TABLETS 0X3.0X4.0
099 TABLET
BLISTER
1513 NDA/MAL/H GLAXOSMITH UNITED HAVRIX144 HEPATITIS A NLT 1440 SMITHKLINE BEECHAM BELGIUM PARENTERAL 1.0X1.0 7/1/1997
DP/2992 KLINE HEALTHCARE 0 ANTIGEN(HM ELISA BIOLOGICALS , BELGIUM- ORDINARY ML VIAL
PHARMACEUT DISTRIBUTORS 175 STRAIN) UNITS OF BELGIUM VIALS (1 DOSE)
ICAL KENYA LTD VIRAL
LTD ANTIGENS(
HM 175
STRAIN)
1514 NDA/MAL/H GITTOES GITTOES GALLOP LOPERAMIDE 2MG AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1.0X10.0X 7/1/2007
DP/2995 PHARMACEUT PHARMACEUTIC HYDROCHLOR NO. 33, SECTOR II, VASAI, ORDINARY 10.0
ICALS LIMITED ALS LIMITED IDE USP TALUKA INDL. OTHER CAPSULE
CAPSULES BLISTER,1.
0X100.0
CAPSULE
CONTAIN
ER
1515 NDA/MAL/H MEDLEY MEDVIN ACENAC ACECLOFENA 100 MG MEDLEY INDIA ORAL SOLID 1.0X10.0X 7/1/2017
DP/2997 PHARMACEUT PHARMA TABLETS C PHARMACEUTICALS LTD- ORDINARY 10.0
ICALS LIMITED PLOT NO.18 AND 19, FILM- TABLET
ESTATE, KACHIGAM,
DAMAN-396210 INDIA
1516 NDA/MAL/H MEDLEY MEDVIN FITIN-5 LEVOCETIRIZI 5MG MEDLEY INDIA ORAL SOLID 1.0X10.0X 7/1/2009
DP/2998 PHARMACEUT PHARMA NE PHARMACEUTICALS LTD- ORDINARY 10.0
ICALS LTD LIMITED DIHYDROCHL PLOT NO 18 & 19, SURVEY FILM- TABLET
ORIDE NO. 378/7& 8,379/2&3 COATED BLISTER
ZARI TABLETS
CAUSEWAY ROAD,,
KACHIGAM, DAMAN-396
210
1517 NDA/MAL/H LEBEN ANDYCO KELVIN PARACETAM 500MG LEBEN LABORATORIES PVT INDIA ORAL SOLID 1.0X10.0X 7/1/2011
DP/3002 LABORATORIE PHARMACY OL LTD --L4 PHASEIII M.I.D.C ORDINARY 10.0
S LTD (UGANDA) LTD AKOLA 444 104 TABLETS TABLET
0X100.0X1
0.0
TABLET
BLISTER,1.
0X1000.0
TABLET
CONTAIN
ER
1518 NDA/MAL/H GITTOES GITTOES AGOVIR ACICLOVIR 200MG AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1.0X10.0X 7/1/2007
E INDIA TABLET
CONTAIN
ER,1.0X10
.0 TABLET
BLISTER
1519 NDA/MAL/H AUROBINDO GITTOES AUROPODO CEFPODOXIM 100MG AUROBINDO PHARMA LTD INDIA ORAL SOLID 1.0X10.0 7/1/2007
DP/3004 PHARMA LTD PHARMACEUTIC X 100 E PROXETIL (UNIT VI) ,.,.,-SURVEY ORDINARY TABLET
ALS LIMITED NOS. 329/39 & 329/47, FILM- BLISTER
CHITKUL VILLAGE, COATED
PATANCHERU MANDAL, TABLETS
MEDAK DISTRICT PIN
CODE 502307, ANDHRA
PRADESH
1520 NDA/MAL/H ACINO GOODMAN OLFEN-100 DICLOFENAC 100MG ACINO PHARMA AG SWITZERLAN ORAL SOLID 1.0X10.0 7/1/1997
DP/3005 PHARMA AG INTERNATIONAL SR SODIUM (FORMER MEPHA LLC)- D RETARD CAPSULE
LTD DEPOCAPS DORNACHERSTRASSE 114 CAPSULES BLISTER
P.O BOX 445 CH4147,
AESCH/BL
DP/3007 PHARMACEUT ENTERPRISES LIMITED(BIOPHARMA ORDINARY 0.0
ICALS LIMITED LIMITED DIVISION)-CAMP ROAD TABLETS TABLET
DEHRADUN
(UTTARAKHAND) INDIA
1522 NDA/MAL/H VHB MEDI LLOYDS BLEOSOL BLEOMYCIN 15 UNITS VHB MEDI SCIENCES LTD- INDIA PARENTERAL 1.0X5.0 7/1/2014
DP/3008 SCIENCES LTD PHARMACY PLOT 20, 21, 22 & 49,50, ORDINARY ML VIAL
5, RUDRAPUR,
UTTARAKHAND - INDIA
1523 NDA/MAL/H VENUS HARLEYS SULBACTO CEFTRIAXONE 1000MG+5 VENUS REMEDIES LTD, INDIA PARENTERAL 1.0X20.0 7/1/2009
DP/3009 REMEDIES UGANDA MAX 1.5G +SULBACTAM 00MG UNIT II,-HILL TOP ORDINARY ML VIAL
LIMITED LIMITED INDUSTRIAL ESTATE, DRY VIALS
JHARMAJTI, EPIP, PHASE-1
KALAN, BADDI -HP
1524 NDA/MAL/H ASTRA LIFE ASTRA PHARMA GYNEST CLOTRIMAZO 100MG ASTRA LIFE CARE (INDIA) INDIA VAGINAL 1.0X6.0 7/1/2008
DP/3011 CARE (INDIA) (U) LIMITED LE PVT-PLOT 57 TABLETS TABLET
PVT LTD ROJADA382220, BAVLA BLISTER
AHMEDABAD INDIA
1525 NDA/MAL/H WIN- SURGIPHARM DICLOMOL DICLOFENAC 50MG WIN MEDICARE PVT INDIA ORAL SOLID 1.0X10.0X 7/1/1998
DP/3012 MEDICARE (U) LIMITED TABLETS SODIUM LIMITED-MEERUT, ORDINARY 10.0
PVT LTD MUZAFFARNAGER ROAD, ENTERIC- TABLET
MODIPURAM – 250110, COATED BLISTER
UTTAR TABLETS
PRADESH - INDIA
1526 NDA/MAL/H GITTOES GITTOES AGOZOLE ALBENDAZOL 400MG AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1.0X1.0X1 7/1/2007
DP/3013 PHARMACEUT PHARMACEUTIC E NO.33,SECTOR ORDINARY .0 TABLET
ICALS LIMITED ALS LIMITED II,VASAI,TALUKA INDL CO- CHEWABLE BLISTER,1.
OP ESTATE LTD,GAURAI TABLETS 0X500.0
E INDIA CONTAIN
ER
1527 NDA/MAL/H CADILA ABACUS PENEGRA- SILDENAFIL 50MG CADILA HEALTHCARE LTD- INDIA ORAL SOLID 1.0X1.0X4 7/1/2001
DP/3015 HEALTHCARE PHARMA 50 TABLETS KUNDAIM INDUSTRIAL ORDINARY .0 TABLET
LTD (AFRICA) ESTATE, PLOT NO.203- TABLETS BLISTER,1.
LIMITED 213, KUNDAIM GOA, 0X20.0X4.
403115, INDIA 0 TABLET
BLISTER
1528 NDA/MAL/H MJ TATA UGANDA BIOSULIN INSULIN 30 I.U + 70 MJ BIOPHARM PRT LTD-L- INDIA PARENTERAL 1.0X10.0 7/1/2008
DP/3019 BIOPHARM LIMITED 30/70 SOLUBLE + I.U 7 MIDC INDUSTRIAL AREA, ORDINARY ML VIAL
PRT LTD INSULIN TALOJA, NARI MUMBAI VIALS
ISOPHANE MAHARASHTRA
1529 NDA/MAL/H M.J TATA UGANDA BIOSULIN N INSULIN 100 I.U/ML M.J .BIOPHARM-L7, INDIA PARENTERAL 1.0X10.0 7/1/2008
DP/3020 BIOPHARM LIMITED ISOPHANE M.I.D.C INDUSTRIAL AREA ORDINARY S ML VIAL
PVT LTD TALOJA, NAVI MUMBAI C VIALS
MAHARAHTRA
1530 NDA/MAL/H GITTOES GITTOES GLIBENCLA GLIBENCLAMI 5MG AGOG PHARMA LIMITED- INDIA ORAL SOLID 1.0X100.0 7/1/2012
DP/3021 PHARMACEUT PHARMACEUTIC MIDE DE PLOT NO.33,SECTOR II,THE ORDINARY X10.0
ICALS LIMITED ALS LIMITED TABLETS VASAI TALUKA INDL.CO- TABLETS TABLET
OP ESTATE LTD.VASAI(E) BLISTER,1.
DIST.THANE,INDIA 0X1000.0
TABLET
CONTAIN
ER,1.0X10
.0X10.0
TABLET
BLISTER
1531 NDA/MAL/H M.J TATA UGANDA BIOSULIN L INSULIN ZINC 100 I.U/ML M.J BIOPHARM PVT LTD -- INDIA PARENTERAL 1.0X10.0 7/1/2008
DP/3022 BIOPHARM LIMITED SUSPENSION L-7 MIDC INDUSTRIAL ORDINARY S ML VIAL
PVT LTD AREA, DIST . RAIGAD , C VIALS
1532 NDA/MAL/H GITTOES GITTOES AGOTRAX LEVAMISOLE 40MG AGOG PHARMA LTD.-PLOT INDIA ORAL SOLID 10.0X10.0 7/1/2007
DP/3023 PHARMACEUT PHARMACEUTIC HYDROCHLOR NO. 33, SECTOR II, VASAI, ORDINARY TABLET
ICALS LIMITED ALS LIMITED IDE TALUKA INDL. TABLETS STRIP,1.0X
10.0X1.0X
3.0
TABLET
STRIP,1.0X
500.0
TABLET
CONTAIN
ER
1533 NDA/MAL/H MYLAN KIMSY MEDS LAMIVUDIN LAMIVUDINE 150MG +

MYLAN LABORATORIES INDIA ORAL SOLID 1.0X60.0 7/1/2008
DP/3024 LABORATORIE LTD E+ + 200MG +
LTD--F-4,F-12 MALEGAON ORDINARY TABLET
S LIMITED NEVIRAPIN NEVIRAPINE 300MGMIDC SINNAR NASHIK TABLETS BOTTLE
E+ + 422113 MAHARASHTRA
ZIDOVUDIN ZIDOVUDINE STATE
E MYLAN LABORATORIES
LTD --H-12 & H-13, MIDC,
WALUJ,AURANGABAD-
431136 MAHARASHTRA,
INDIA QUESTA CARE
LIMITED-PLOT NO
209/7184 HOMABAY RD
1534 NDA/MAL/H GITTOES GITTOES AGOZOLE ALBENDAZOL 200 MG/ 5 AGOG PHARMA LTD-PLOT INDIA ORAL LIQUID 1.0X10.0 7/1/2007
DP/3029 PHARMACEUT PHARMACEUTIC SUSPENSIO E USP ML NO.33,SECTOR ORDINARY ML
ICALS LIMITED ALS LIMITED N II,VASAI,TALUKA INDL CO- SUSPENSION BOTTLE
OP ESTATE LTD,GAURAI S
E INDIA
1535 NDA/MAL/H MJ TATA UGANDA BIOSULIN R INSULIN 100 IU/ML M.J BIOPHARM PVT LTD -- INDIA PARENTERAL 1.0X10.0 7/1/2008
DP/3030 BIOPHARM LIMITED SOLUBLE L-7 MIDC INDUSTRIAL ORDINARY S ML VIAL
PVT LTD AREA, DIST . RAIGAD , C VIALS
1536 NDA/MAL/H GITTOES GITTOES AGOMETHA DEXAMETHAS 0.5MG AGOG PHARMA LTD.-NO. INDIA ORAL SOLID 1.0X10.0X 7/1/2007
DP/3031 PHARMACEUT PHARMACEUTIC SONE ONE 33, SECTOR II, VASAI, ORDINARY 10.0
BLISTER,1.
0X1000.0
TABLET
CONTAIN
ER
1537 NDA/MAL/H ACINO GOODMAN XYLO- XYLOMETAZO 0.05%W/V MERCKLE GMBH,-LUDWIG GERMANY NASAL 1.0X10.0 7/1/2007
DP/3032 PHARMA AG INTERNATIONAL ACINO LINE MERCKLE STRASSE3 D- TOPICAL ML
LTD 0.05% 89143 BLAUBEUREN SPRAYS BOTTLE
WITHOUT
GAS
1538 NDA/MAL/H GLAXOSMITH UNITED PENAMOX AMOXICILLIN 125MG/5 MEDREICH STERILAB LTD- INDIA ORAL LIQUID 1.0X100.0 7/1/1997
DP/3033 KLINE HEALTHCARE ML 12TH MILE, OLD MADRAS ORDINARY ML
PHARMACEUT DISTRIBUTORS ROAD, VIRGONAGOR, DRY BOTTLE
ICAL KENYA LTD BANGALORE 560049, SUSPENSION
ROPS
1539 NDA/MAL/H GITTOES GITTOES AGOFORTE FERRIC 50MG + AGOG PHARMA LIMITED- INDIA ORAL LIQUID 1.0X200.0 7/1/2007
DP/3035 PHARMACEUT PHARMACEUTIC TONIC AMMONIUM 0.55MG + PLOT NO.33,SECTOR II,THE ORDINARY ML
ICALS LIMITED ALS LIMITED CITRATE + 2.4MG + VASAI TALUKA INDL.CO- SYRUPS BOTTLE,1.
FOLIC ACID + 1.2MG + OP ESTATE LTD.VASAI(E) 0X60.0 ML
PYRIDOXINE 11MG + DIST.THANE,INDIA BOTTLE,1.
HCL + 2.5MG 0X1.0X100
THIAMINE .0 ML
HCL + BOTTLE
NICOTINAMI
DE + VITAMIN
B12
1540 NDA/MAL/H GITTOES GITTOES AGOVIT VITAMIN A + 1000I.U + AGOG PHARMA LIMITED- INDIA ORAL LIQUID 1.0X1.0X6 7/1/2007
DP/3037 PHARMACEUT PHARMACEUTIC SYRUP VITAMIN D3 + 200I.U + PLOT NO.33,SECTOR II,THE ORDINARY 0.0 ML
ICALS LIMITED ALS LIMITED VITAMIN B1 + 1.5MG + VASAI TALUKA INDL.CO- SYRUPS BOTTLE,1.
VITAMIN B2 + 1.5MG+ OP ESTATE LTD.VASAI(E) 0X1.0X100
NIACINAMIDE 10MG + DIST.THANE,INDIA .0 ML
+ VITAMIN 2.5MCG + BOTTLE
B12 + 40MG
VITAMIN C
1541 NDA/MAL/H GITTOES GITTOES AGODOX DOXYCYCLINE 100MG AGOG PHARMA LIMITED- INDIA ORAL SOLID 1.0X100.0 7/1/2007
DP/3040 PHARMACEUT PHARMACEUTIC PLOT NO.33,SECTOR II,THE ORDINARY X10.0
ICALS LIMITED ALS LIMITED VASAI TALUKA INDL.CO- CAPSULES CAPSULE
DIST.THANE,INDIA 0X1000.0
CAPSULE
CONTAIN
ER,1.0X10
0.0
CAPSULE
CONTAIN
ER,1.0X10
1542 NDA/MAL/H CIPLA LTD QUALITY LEVOFLOXA LEVOFLOXACI 250MG CIPLA LTD.- -PLOT NO INDIA ORAL SOLID 1.0X10.0X 7/1/2009
DP/3041 CHEMICALS LTD - CIN N L/139 TO L/146, VERNA ORDINARY 10.0
HUMAN INDUSTRIAL ESTATE, TABLETS TABLET
VERNA, SOUTH GOA BLISTER
DISTRICT, 403722 GOA
1543 NDA/MAL/H INDOCO STAR FEBREX PARACETAM 500MG INDOCO REMEDIES LTD-B- INDIA ORAL SOLID 1.0X10.0X 7/1/2007
DP/3043 REMEDIES PHARMACEUTIC TABLETS OL 20, MIDC, WALUJ, ORDINARY 10.0
LTD ALS LTD AURANGABAB 431136 TABLETS TABLET
INDIA BLISTER,1.
0X1000.0
TABLET
CONTAIN
ER
1544 NDA/MAL/H CADILA ABACUS PIRICAM-20 PIROXICAM 20MG CADILA HEALTHCARE INDIA ORAL SOLID 10.0X10.0 7/1/1997
DP/3044 HEALTHCARE PHARMA CAPSULES LIMITED--KUNDAIM ORDINARY CAPSULE
LTD (AFRICA) INDUSTRIAL ESTATE, PLOT CAPSULES BLISTER,2.
LIMITED NO. 203-213, 0X10.0
KUNDAIM,GOA-403 115, CAPSULE
INDIA BLISTER
1545 NDA/MAL/H GLAXO UNITED CLAVULIN AMOXICILLIN 400 MG + SMITHKLINE BEECHAM UNITED ORAL LIQUID 1.0X70.0 7/1/2009
DP/3046 SMITHLINE HEALTHCARE + 57 MG PHARMACEUTICALS,- KINGDOM ORDINARY ML
LIMITED DISTRIBUTORS CLAVULANIC CLARENDON ROAD, DRY BOTTLE
LTD ACID WORTHING, WEST SUSPENSION
SUSSEX, BN148QH S/SYRUPS/D
ROPS
1546 NDA/MAL/H MYLAN KIMSY MEDS ABACAVIR ABACAVIR 300 MG + MYLAN LABORATORIES INDIA ORAL SOLID 1.0X30.0 7/1/2008
DP/3047 LABORATORIE LTD SULFATE+L SULFATE + 150 MG + LIMITED.-PLOT NO. H-12 & ORDINARY TABLET
S LIMITED AMIVUDINE LAMIVUDINE 300 MG H-13 FILM- CONTAIN
+ZIDOVUDI + MIDC, WALUJ INDUSTRIAL COATED ER
NE ZIDOVUDINE AREA, TABLETS
AURANGABAD. – 431136,
MAHARASHTRA STATE,
INDIA.
1547 NDA/MAL/H GITTOES GITTOES TRIMAGO- SULFAMETHO 800MG/16 AGOG PHARMA LIMITED- INDIA ORAL SOLID 1.0X6.0X1 7/1/2007
DP/3048 PHARMACEUT PHARMACEUTIC DS TABLETS XAZOLE/TRIM 0MG PLOT NO.33,SECTOR II,THE ORDINARY 0.0
ICALS LIMITED ALS LIMITED ETHOPRIM VASAI TALUKA INDL.CO- TABLETS TABLET
DIST.THANE,INDIA 0X2.0X14.
0 TABLET
BLISTER,1.
0X10.0X10
.0 TABLET
CONTAIN
ER,1.0X3.
0X10.0
1548 NDA/MAL/H CIPLA LTD.. QUALITY EFAVIRENZ EFAVIRENZ 600MG CIPLA LTD.- -PLOT NO INDIA ORAL SOLID 1.0X30.0 7/1/2007
DP/3049 CHEMICALS LTD - L/139 TO L/146, VERNA ORDINARY TABLET
HUMAN INDUSTRIAL ESTATE, TABLETS BOTTLE
VERNA, SOUTH GOA
1549 NDA/MAL/H SHAIGAN HEALTHCARE PEFLOX PEFLOXACIN 400MG SHAIGAN PAKISTAN ORAL SOLID 1.0X10.0
DP/3050 PHARMACEUT LTD. PHARMACEUTICALS (PVT) ORDINARY TABLET
ICALS LTD LTD-14TH KM, ADYALA TABLETS BLISTER
ROAD, RAWALPINDI-
PAKISTAN
1550 NDA/MAL/H BETA BETA BETROZOLE DILOXANIDE 125MG+16 BETA HEALTHCARE KENYA ORAL LIQUID 1.0X100.0 7/1/2005
DP/3051 HEALTHCARE HEALTHCARE FUROATE+ME 0MG+25M INTERNATIONAL LTD - - ORDINARY ML
UGANDA UGANDA TRONIDAZOL G PLOT SUSPENSION BOTTLE,1.
LIMITED LIMITED E NO.209/6554,MOGADISHU S 0X60.0 ML
BENZOATE+SI ROAD,OFF LUNGA LUNGA BOTTLE
METHICONE INDUSTRIAL AREA,
P.O.BOX 42569-001000
NAIROBI,KENYA
1551 NDA/MAL/H GUILIN STAR IBUPROFEN IBUPROFEN 200MG GUILIN PHARMACEUTICAL CHINA ORAL SOLID 1.0X1000. 7/1/2010
DP/3052 PHARMACEUT PHARMACEUTIC TABLETS CO. LTD-NO. 17 SHANGHAI ORDINARY 0 TABLET
ICALS CO.LTD ALS LTD ROAD, GUILIN 541002, OTHER CONTAIN
GUANXI CHINA COATED ER
TABLETS
1552 NDA/MAL/H INDOCO STAR NOSIC DOXYLAMINE 10MG+10 INDOCO REMEDIES LTD - 0- INDIA ORAL SOLID 1.0X3.0X1 7/1/2010
DP/3054 REMEDIES PHARMACEUTIC SUCCINATE + MG .L-14 VERNA INDUSTRIAL ORDINARY 0.0
LIMITED ALS LTD PYRIDOXINE AREA, VERNA, GOA- ENTERIC- TABLET
HYDROCHLOR 403722 COATED BLISTER
IDE TABLETS
1553 NDA/MAL/H CIPLA LTD. QUALITY ABACAVIR ABACAVIR 300MG CIPLA LTD-MIDC INDIA ORAL SOLID 1.0X60.0 7/1/2007
DP/3055 CHEMICALS LTD - SULFATE SULPHATE PATALGANGA 410 220 ORDINARY TABLET
HUMAN DIST. RAIGAD TABLETS BOTTLE
1554 NDA/MAL/H GITTOES GITTOES COLD-A-GO PARACETAM 400MG + AGOG PHARMA LIMITED- INDIA ORAL SOLID 1.0X2.0X1 7/1/2007
DP/3057 PHARMACEUT PHARMACEUTIC CAPSULES OL + 5MG + PLOT NO.33,SECTOR II,THE ORDINARY 0.0
ICALS LIMITED ALS LIMITED PHENYLEPHRI 12.5MG + VASAI TALUKA INDL.CO- CAPSULES CAPSULE
NE 30MG OP ESTATE LTD.VASAI(E) BLISTER,1.
HYDROCHLOR DIST.THANE,INDIA 0X10.0X10
IDE + .0
DIPHENHYDR CAPSULE
AMINE + BLISTER
CAFFEINE
1555 NDA/MAL/H SANOFI- SURGIPHARM XATRAL LP ALFUZOSIN 10MG SANOFI WINTHROP FRANCE ORAL SOLID 1.0X3.0X1 7/1/2008
DP/3058 AVENTIS (U) LIMITED 10MG INDUSTRIE,-30-36, ORDINARY 0.0
AVENUE GUSTAVEEIFFEL COATED TABLET
BP 27166 - 37071 TOURS TABLETS BLISTER
CEDEX 2
1556 NDA/MAL/H GITTOES GITTOES KETOS KETOCONAZO 200 MG AGOG PHARMA LIMITED- INDIA ORAL SOLID 1.0X3.0X1 7/7/2007
DP/3060 PHARMACEUT PHARMACEUTIC TABLET LE USP PLOT NO.33,SECTOR II,THE ORDINARY 0.0
ICALS LIMITED ALS LIMITED VASAI TALUKA INDL.CO- TABLETS TABLET
DIST.THANE,INDIA 0X10.0X10
.0 TABLET
BLISTER
1557 NDA/MAL/H MULTISORB QUALITY LAMIVUDIN LAMIVUDINE/ 150MG + CIPLA LTD .-PLOT NO. 9, INDIA ORAL SOLID 1.0X60.0 7/1/2007
DP/3062 CHEMICALS LTD - E,ZIDOVUDI ZIDOVUDINE/ 300MG + 10 AND 15, INDORE ORDINARY TABLET
HUMAN NE, NEVIRAPINE 200MG SPECIAL ECONOMIC ZONE, FILM- BOTTLE
NEVIRAPIN PHASE –II, PITHAMPUR, COATED
E DISTRICT DHAR, PIN TABLETS
CODE: 454775, MADHYA
PRADESH CIPLA LTD.- -
PLOT NO L/139 TO L/146,
VERNA INDUSTRIAL
ESTATE, VERNA, SOUTH
GOA DISTRICT, 403722
GOA
1558 NDA/MAL/H GITTOES GITTOES AGODIC-50 DICLOFENAC 50MG AGOG PHARMA LTD.-NO. INDIA ORAL SOLID 1.0X10.0X 7/1/2007
DP/3063 PHARMACEUT PHARMACEUTIC SODIUM 33, SECTOR II, VASAI, ORDINARY 10.0
BLISTER,1.
0X1000.0
TABLET
CONTAIN
ER,1.0X10
0.0
TABLET
CONTAIN
ER,1.0X10
1559 NDA/MAL/H GITTOES GITTOES TIN-TIN TINIDAZOLE 500MG AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1.0X4.0 7/1/2007
DP/3064 PHARMACEUT PHARMACEUTIC TABLETS NO.33,SECTOR ORDINARY TABLET
ICALS LIMITED ALS LIMITED II,VASAI,TALUKA INDL CO- FILM- BLISTER
OP ESTATE LTD,GAURAI COATED
PADA,VASAI(E)DIST.THAN TABLETS
E INDIA
1560 NDA/MAL/H GITTOES GITTOES PROMAGO PROMETHAZI 5MG/5ML AGOG PHARMA LIMITED- INDIA ORAL LIQUID 1.0X1.0X1 7/1/2007
DP/3067 PHARMACEUT PHARMACEUTIC SYRUP NE PLOT NO.33,SECTOR II,THE ORDINARY 00.0 ML
ICALS LIMITED ALS LIMITED VASAI TALUKA INDL.CO- SYRUPS BOTTLE,1.
OP ESTATE LTD.VASAI(E) 0X1.0X60.
DIST.THANE,INDIA 0 ML
BOTTLE
1561 NDA/MAL/H GITTOES GITTOES AGOMOVE PIROXICAM 20MG AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1.0X10.0X 7/1/2007
DP/3069 PHARMACEUT PHARMACEUTIC CAPSULES NO.33,SECTOR ORDINARY 10.0
E INDIA CAPSULE
CONTAIN
ER
1562 NDA/MAL/H GITTOES GITTOES AGOMOL PARACETAM 500 MG AGOG PHARMA LIMITED- INDIA ORAL SOLID 1.0X500.0 7/1/1998
DP/3072 PHARMACEUT PHARMACEUTIC TABLETS(T OL PLOT NO.33,SECTOR II,THE ORDINARY TABLET
ICALS LIMITED ALS LIMITED HANE) VASAI TALUKA INDL.CO- TABLETS CONTAIN
OP ESTATE LTD.VASAI(E) ER,1.0X10
DIST.THANE,INDIA 00.0
TABLET
CONTAIN
ER,1.0X10
0.0X10.0
TABLET
BLISTER,1.
0X10.0X10
1563 NDA/MAL/H COSMOS LTD ASTRA PHARMA CARDINOL ATENOLOL 50MG COSMOS LTD.-RANGWE KENYA ORAL SOLID 2.0X14.0 7/1/1997
DP/3073 (U) LIMITED TABLET ROAD; OFF LUNGA LUNGA ORDINARY TABLET
ROAD. P.O BOX 414 33, FILM- STRIP
NAIROBI COATED
TABLETS
1564 NDA/MAL/H ARISTO NORVIK ARISTO TELMISARTA 40MG ARISTO PHAMACUTLAB INDIA ORAL SOLID 1.0X10.0X 7/1/2007
DP/3076 PHARMACEUT ENTERPRISES TELVAS 40 N PVT LTD-PLOT NO.208 ORDINARY 10.0
ICALS PVT LTD LIMITED NEW INDUSTRIAL AREA TABLETS TABLET
NO.2 MANIDIDEEP STRIP
462.046
1565 NDA/MAL/H REGAL REGAL PHARMA UNISTEN CLOTRIMAZO 1%W/W + REGAL PHERMACUTICALS - KENYA TOPICAL 1.0X20.0 7/1/2008
DP/3077 PHARMACEUT (U) LTD HC CREAM LE + 1%W/W PLOT 7879/18 OFF BABA EXTERNAL G TUBE
ICALS LTD HYDROCORTI RWARAKA NAIROBI CREAMS
SONE KENYA
1566 NDA/MAL/H JOHNSON&JO PHILLIPS SINUTAB PARACETAM 500MG/ JOHNSON&JOHNSON PTY SOUTH ORAL SOLID 1.0X2.0X1 7/1/2010
DP/3078 HNSON PTY PHARMACEUTIC ALLERGY OL/ 2MG/ LTD.-EDMS BPK241 MAIN AFRICA ORDINARY 0.0
LTD ALS (UGANDA) CONGESTIO CHLORPHENI 30MG ROAD /HOOFWEG TABLETS TABLET
LIMITED N RAMINE/ 241,RETREAT 7945,SOUTH BLISTER
EPHEDRINE AFRICA
1567 NDA/MAL/H ARISTO NORVIK ARISTO TELMISARTA 80MG ARISTO INDIA ORAL SOLID 1.0X10.0X 7/1/2007
DP/3083 PHARMACEUT ENTERPRISES TELVAS 80 N PHARMACEUTICALS PVT. ORDINARY 10.0
ICALS PVT LTD LIMITED LIMITED-PLOT NO. 208, TABLETS TABLET
NEW INDUSTRIAL AREA STRIP
NO.II,MANDIDEEEP
PRADESH
1568 NDA/MAL/H CIPLA QUALITY NEVIRAPIN NEVIRAPINE 200MG CIPLA LTD--PLOT NO L- INDIA ORAL SOLID 1.0X60.0 7/1/2007
DP/3084 LIMITED CHEMICALS LTD - E 139,VERNA IND ESTATE, ORDINARY TABLET
HUMAN VERNA GOA-403 INDIA TABLETS CONTAIN
ER
1569 NDA/MAL/H GITTOES GITTOES AGOCOLD PARACETAM 500.MG+5. AGOG PHARMA LIMITED- INDIA ORAL SOLID 1.0X25.0X 7/1/2007
DP/3085 PHARMACEUT PHARMACEUTIC TABLETS OL+PHENYLE 0MG+30.0 PLOT NO.33,SECTOR II,THE ORDINARY 4.0
ICALS LIMITED ALS LIMITED PHRINE MG+2.0M VASAI TALUKA INDL.CO- TABLETS TABLET
HCL+CAFFEIN G OP ESTATE LTD.VASAI(E) BLISTER,1.
E+CHLORPHE DIST.THANE,INDIA 0X10.0X10
NIRAMINE .0 TABLET
HYDROCHLOR BLISTER,1.
IDE 0X4.0
TABLET
BLISTER,1.
0X50.0X4.
0 TABLET
1570 NDA/MAL/H CIPLA LTD QUALITY PILL 72 LEVONORGES 0.75MG CIPLA LTD.- -PLOT NO INDIA ORAL SOLID 1.0X2.0 7/1/2014
DP/3088 CHEMICALS LTD - TREL L/139 TO L/146, VERNA ORDINARY TABLET
HUMAN INDUSTRIAL ESTATE, TABLETS BLISTER
VERNA, SOUTH GOA
1571 NDA/MAL/H PHARMA OMAB UGANDA CEFODOX CEFPODOXIM 100MG/5 PHARMA INTERNATIONAL JORDAN ORAL LIQUID 1.0X50.0 7/1/2004
DP/3090 INTERNATION LIMITED E PROXETIL ML CO.-AMMAN JORDAN ORDINARY ML
AL CO PLANT DRY BOTTLE
AL-QARTAL MARKETING SUSPENSION
DEPARTMENT S/SYRUPS/D
ALBUJAH COMPLEX, ROPS
ALJUBAIHA
1572 NDA/MAL/H SAKAR ROYAL PHARMA ONDI ONDANSETR 2MG/ML SAKAR HEALTH CARE PVT, INDIA PARENTERAL 1.0X2.0X5 7/1/2013
DP/3091 HEALTH CARE 2011 LIMITED ON LTD-BLOCK NO. 10-13,M.N ORDINARY .0X2.0 ML
PVT .LTD DESAI PETROL AMPOULES AMPOULE
PUMP,SARKHEJ-BAVLA
ROAD,VILLAGE
CHANGODAR DIST
AHMEDABAD 382-
213,GUJARAT-INDIA
1573 NDA/MAL/H NOVARTIS SURGIPHARM EXFORGE AMLODIPINE 10MG + NOVARTIS PHARMA STEIN SWITZERLAN ORAL SOLID 1.0X4.0X7 7/1/2015
DP/3092 PHARMA (U) LIMITED HCT + VALSARTAN 160MG AG- D ORDINARY .0 TABLET
SERVICES INC 10MG/160 + +12.5MG SCHAFFHARVSERTRASSE FILM- BLISTER
MG/12.5M HYDROCHLOR CH-4332 STEIN COATED
G OTHIAZIDE SWITZERLAND. NOVARTIS TABLETS
FARMACEUTICA SA-
RONDA DE SANTA
MARIA,158, E-08210
BARBERA DEL VALLES
BARCELONA SPAIN
1574 NDA/MAL/H LEBEN ANDYCO AMPHEN CHLORAMPH 125MG/5 LEBEN LABORATORIES PVT INDIA ORAL LIQUID 1.0X100.0 7/1/2007
DP/3095 LABORATORIE PHARMACY SUSPENSIO ENICOL ML LTD --L4 PHASEIII M.I.D.C ORDINARY ML
S PVT LTD (UGANDA) LTD N PALMITATE AKOLA 444 104 SUSPENSION BOTTLE
MAHARASHTRA S
1575 NDA/MAL/H PHARMA OMAB UGANDA DEBACRON GLICLAZIDE 80MG PHARMA INTERNATIONAL JORDAN ORAL SOLID 1.0X30.0 7/1/2008
DP/3097 INTERNATION LIMITED COMPANY-MAIN STREET, ORDINARY TABLET
AL COMPANY AL QASTAL INDUSTRIAL TABLETS BLISTER
AREA AMMAN- JORDAN
JORDAN
1576 NDA/MAL/H AMOUN WIDE MOSEDIN LORATADINE 5MG/5ML AMOUN EGYPT ORAL LIQUID 1.0X60.0 7/1/2004
DP/3098 PHARMACEUT SPECTRUM PHARMACEUTICALS CO. ORDINARY ML
ICAL ENTERPRISES S.A.E-1ST INDUSTRIAL SYRUPS BOTTLE
COMPANY (U) LIMITED ZONE, EL-OBOUR CITY,
EGYPT.
1577 NDA/MAL/H PHARMA OMAB UGANDA ZONA 0.1% HYDROCORTI 0.1%W/W PHARMA INTERNATIONAL JORDAN TOPICAL 1.0X1.0X3 7/1/2007
DP/3099 INTERNATION LIMITED CREAM SONE 17- CO.,-AL-QASTAL AREA, EXTERNAL 0.0 G
AL COMPANY BUTYRATE AIRPORT ROAD, 11941, CREAMS TUBE
AMMAN
1578 NDA/MAL/H DAWA SUPER MEDIC DACOLD PARACETAM 120MG/5 DAWA LTD-BABA DOGO KENYA ORAL LIQUID 1.0X100.0 7/1/2010
DP/3101 LIMITED LTD SYRUP OL + ML+10MG/ ROAD RUARAKA ORDINARY ML
PSEUDOEPHE 5ML+2MG/ SYRUPS BOTTLE
DRINE HCL + 5ML
CHLORPHENI
RAMINE
MALEATE
1579 NDA/MAL/H PFIZER LABOREX EPANUTIN PHENYTOIN 50MG/ML ACTAVIS ITALY S.P.A-VIALE ITALY PARENTERAL 1.0X5.0X5 7/1/1997
DP/3102 LABORATORIE UGANDA READY SODIUM PASTEUR, 10 20014 ORDINARY .0 ML
S (PTY) LTD LIMITED MIXED NERVIANO(MILAN) - ITALY AMPOULES AMPOULE
1580 NDA/MAL/H LEBEN ANDYCO NYSTALEB NYSTATIN 100000IU/ LEBEN LABORATORIES PVT INDIA ORAL LIQUID 1.0X30.0 7/1/2007
DP/3104 LABORATORIE PHARMACY ORAL ML LTD --L4 PHASEIII M.I.D.C ORDINARY ML
S PVT LTD (UGANDA) LTD SUSPENSIO AKOLA 444 104 SUSPENSION BOTTLE
N MAHARASHTRA S
1581 NDA/MAL/H CADILA ABACUS DEPIN-E NIFEDIPINE 20MG CADILA HEALTHCARE INDIA ORAL SOLID 1.0X10.0X 7/1/1997
DP/3105 HEALTH CARE PHARMA RETARD LIMITED--KUNDAIM RETARD 10.0
LIMITED (AFRICA) INDUSTRIAL ESTATE, PLOT TABLETS TABLET
LIMITED NO. 203-213, STRIP
INDIA
1582 NDA/MAL/H IPCA MEDVIN ZERODOL ACECLOFENA 100MG IPCA LABORATORIES INDIA ORAL SOLID 1.0X10.0X 7/1/2005
DP/3108 LABORATOIES PHARMA C LTD,PLOT NO. T-139 - ORDINARY 10.0
LTD LIMITED SEJAVTA, RATLAM-457 002 TABLETS TABLET
(M.P.) INDIA BLISTER,1.
0X3.0X10.
0 TABLET
BLISTER
1583 NDA/MAL/H VENUS AARON ZYDOTUM CEFTAZIDIME 1000 MG + VENUS REMEDIES LTD, INDIA PARENTERAL 1.0X20.0 7/1/2011
DP/3110 REMEDIES PHARMACEUTIC + 500 MG UNIT II,-HILL TOP ORDINARY ML VIAL
LIMITED ALS LTD SULBACTAM INDUSTRIAL ESTATE, DRY VIALS
KALAN, BADDI -HP
1584 NDA/MAL/H GLAXOSMITH UNITED CALPOL PARACETAM 120MG/5 GLAXOSMITHKLINE KENYA ORAL LIQUID 1.0X100.0 7/1/1997
DP/3111 KLINE LTD HEALTHCARE OL ML LIMITED - -78392-00507, ORDINARY ML
DISTRIBUTORS VIWANDANI LIKONI ROAD SYRUPS BOTTLE,1.
LTD NAIROBI KENYA 0X60.0 ML
BOTTLE
1585 NDA/MAL/H LABORATORY HARLEYS KLOXY CLOXACILLIN 125MG/5 LABORATORY & ALLIED KENYA ORAL LIQUID 1.0X1.0X1 7/1/1997
DP/3116 & ALLIED LTD UGANDA ML LTD.---PLOT 209/10349 ORDINARY 00.0 ML
LIMITED OFF MOMBASA RD DRY BOTTLE,1.
NAIROBI SUSPENSION 0X100.0
S/SYRUPS/D ML
ROPS BOTTLE
1586 NDA/MAL/H KARNATAKA TATA UGANDA HYDROCOR HYDROCORTI 100MG KARNATAKA ANTIBIOTICS INDIA PARENTERAL 1.0X10.0X 7/1/2010
DP/3117 ANTIBIOTICS LIMITED TISONE SONE & PHARMACEUTICALS LTD- ORDINARY 100.0 MG
& SODIUM SODIUM #14, II PHASE PIA, DRY VIALS VIAL,1.0X
PHARMACEUT SUCCINATE SUCCINATE BANGALORE 560058 50.0X100.
ICALS LTD 0 MG VIAL
1587 NDA/MAL/H CIPLA CIPLA QUALITY LUMARTEM ARTEMETHER 20MG QUALITY CHEMICAL UGANDA ORAL SOLID 1.0X1.0X2 7/1/2011
DP/3118 QUALITY CHEMICAL /LUMEFANTRI /120MG INDUSTRIES LIMITED. - ORDINARY 4.0
CHEMICAL INDUSTRIES NE PLOT NO. 1-7 LUZIRA TABLETS TABLET
INDUSTRIES LIMITED INDUSTRIAL PARK, BLISTER,1.
LIMITED KAMPALA 0X30.0X18
.0 TABLET
BLISTER,1.
0X30.0X24
.0 TABLET
BLISTER,1.
0X30.0X12
.0 TABLET
1588 NDA/MAL/H USV PRIVATE ABACUS GROVIT MULTI- MULTI- REMIDEX PHARMA PVT INDIA ORAL SOLID 1.0X3.0X1 7/1/2002
DP/3122 LIMITED PHARMA CHEWABLE INGREDIENT INGREDIEN LTD- B-249+ 250 II STAGE ORDINARY 0.0
(AFRICA) TABLETS T PEENYA INDUSTRIAL CHEWABLE TABLET
LIMITED ESTATE BANGLORE TABLETS BLISTER
560058.
1589 NDA/MAL/H DAR AL DAWA GAMA AMLODAR AMLODIPINE 5MG DAR AL DAWA-NA'UR JORDAN ORAL SOLID 1.0X2.0X1 7/1/2009
DP/3125 DEVELOPMEN PHARMACEUTIC 5 BESILATE PLANT AMMAN ORDINARY 4.0
INVESTMENT BLISTER
CO LTD
1590 NDA/MAL/H AUROBINDO GITTOES DIDANOSIN DIDANOSINE 250MG AUROBINDO PHARMA LTD- INDIA ORAL SOLID 1.0X30.0 7/1/2009
DP/3127 PHARMA LTD PHARMACEUTIC E DELAYED - DELAYED UNIT III-SURVEY RETARD CAPSULE
ALS LIMITED RELEAS RELEASE NO.313,BACHUPALLY CAPSULES CONTAIN
R MANDAL R.R
DISTRICT(A.P),INDIA
1591 NDA/MAL/H MEDREICH SURGIPHARM OMIZEC OMEPRAZOLE 20MG MEDREICH LIMITED (UNIT- INDIA ORAL SOLID 1.0X4.0X7 7/1/2010
DP/3133 LTD (U) LIMITED 7)-SURVEY NO. ORDINARY .0
11,12,13,14 AND 15, ENTERIC- CAPSULE
POOJARAMANAHALLI COATED BLISTER
VILLAGE, BANGALORE CAPSULES
RURAL DISTRICT-562114
1592 NDA/MAL/H PANACEA VITACARE TOFF PLUS PARACETAM 500 MG + PANACEA BIOTEC LTD- INDIA ORAL SOLID 1.0X2.0X1 7/1/2004
DP/3134 BIOTEC LTD LIMITED OL+CHLORPH 2 MG + 15 MALPUR, BADDI, TEHSIL, ORDINARY 0.0
ENIRAMINE MG + 10 NALAGARH, DIST. SOLAN CAPSULES CAPSULE
MALEATE+ MG (H.P) – 173 205 BLISTER
DEXTROMET
HORPHAN +
PHENYLEPHRI
NE
1593 NDA/MAL/H MYLAN KIMSY MEDS TENOFOVIR TENOFOVIR 300MG MYLAN LABORATORIES INDIA ORAL SOLID 1.0X30.0 7/1/2007
DP/3136 LABORATORIE LTD DISOPROXIL DISOPROXIL LTD--F-4,F-12 MALEGAON ORDINARY TABLET
S LIMITED FUMARATE FUMARATE MIDC SINNAR NASHIK FILM- BOTTLE
422113 MAHARASHTRA COATED
STATE TABLETS
1594 NDA/MAL/H JOHNSON&JO PHILLIPS ANUSOL BISMUTH 59 MG + PERFORMANCE HEALTH SOUTH TOPICAL 1.0X10.0 7/1/1997
DP/3138 HNSON PTY PHARMACEUTIC SUPPOSITO SUBGALLATE 24 MG + LTD-241 NAIN ROAD AFRICA EXTERNAL SUPPOSIT
LTD ALS (UGANDA) RY + BISMUTH 296 MG RETREAT SOUTH AFRICA SUPPOSITORI ORY
LIMITED OXIDE + ZINC 7945 ES BLISTER
OXIDE
1595 NDA/MAL/H DAR AL DAWA GAMA OMEDAR OMEPRAZOLE 20MG DAR AI DAWA-NA UR JORDAN ORAL SOLID 1.0X1.0X1 7/1/2009
DP/3139 DEVELOPMEN PHARMACEUTIC PLANT,AMMAN,JORDAN ORDINARY 4.0
INVESTMENT BLISTER,1.
CO LTD 0X2.0X14.
0 TABLET
BLISTER
1596 NDA/MAL/H BETA BETA ULTIVA REMIFENTANI 1ML GLAXOSMITHKLINE ITALY PARENTERAL 1.0X1.0 7/1/1999
UGANDA UGANDA 1MG STRADA PROVINCIALE VIALS CARTON
S.POLO DI TORRILE
(PARMA)
1597 NDA/MAL/H CIPLA LTD. QUALITY AMLOPRES AMLODIPINE 5MG CIPLA LTD-CIPLA LTD PLOT INDIA ORAL SOLID 1.0X10.0X 7/1/2007
DP/3141 CHEMICALS LTD - S-5 BESYLATE NO L-139,VERNA IND ORDINARY 1.0X10.0
HUMAN ESTATE, VERNA GOA TABLETS TABLET
INDIA BLISTER
1598 NDA/MAL/H MJ TATA UGANDA OMIPIX 20 OMEPRAZOLE 20 MG M.J BIOPHARM PVT LTD -- INDIA ORAL SOLID 1.0X5.0X1 7/1/2009
DP/3143 BIOPHARM LIMITED L-7 MIDC INDUSTRIAL ORDINARY 0.0
PVT LTD AREA, DIST . RAIGAD , CAPSULES CAPSULE
TALOJA , NAVI MUMBAI BLISTER,1.
0X10.0X10
.0
CAPSULE
BLISTER
1599 NDA/MAL/H KAMPALA KAMPALA ULSEC OMEPRAZOLE 20MG KAMPALA UGANDA ORAL SOLID 1.0X3.0X1 7/1/2007
DP/3144 PHARMACEUT PHARMACEUTIC PHARMECEUTICALS ORDINARY 0.0
ICAL AL INDUSTRIES INDUSTRIES LTD-PLOT CAPSULES CAPSULE
INDUSTRIES 1996 LIMITED M444B STRETCHER RD, STRIP
1996 LIMITED NTINDA KLA UGANDA
1600 NDA/MAL/H HOVID BHD UNITED AMOXICAP AMOXYCILLIN 500MG HOVID BHD -121 ,JALAN MALAYSIA ORAL SOLID 1.0X10.0X 7/1/2010
DP/3145 HEALTHCARE TUNKU ABDUL RAHMAN , ORDINARY 10.0
DISTRIBUTORS 30010 IPOH , PERAK , CAPSULES CAPSULE
LTD MALAYSIA BLISTER
1601 NDA/MAL/H UNICHEM EUROPA ZOKAST MONTELUKAS 10MG UNICHEM LABORATORIES INDIA ORAL SOLID 1.0X10.0X 7/1/2016
DP/3146 LABORATORIE HEALTHCARE T SODIUM LTD ,.,-PLOT 17 & 18, ORDINARY 10.0
S LTD (U) LTD PILERNE IND. ESTATE, FILM- TABLET
PILERNE, BARDEZ GOA- COATED BLISTER
403511 TABLETS
1602 NDA/MAL/H ARISTO NORVIK ARISTO TELMISARTA 40MG/12.5 ARISTO INDIA ORAL SOLID 1.0X10.0X 7/1/2009
DP/3147 PHARMACEUT ENTERPRISES TELVAS-H N/HYDROCHL MG PHARMACEUTICALS PVT ORDINARY 10.0
ICALS PVT LTD LIMITED 40/12.5 OROTHIAZIDE LIMITED-PLOT 208, NEW TABLETS TABLET
INDUSTRIAL AREA NO II, STRIP
MANDIDEEP-462 046
(DISTRICT) RAISEN,
1603 NDA/MAL/H VHB MEDI LLOYDS MTX-VHB METHOTREXA 50MG/2ML VHB MEDI SCIENCES LTD- INDIA PARENTERAL 1.0X2.0 7/1/2010
DP/3150 SCIENCES LTD PHARMACY TE PLOT 20, 21, 22 & 49,50, ORDINARY ML VIAL
5, RUDRAPUR,
UTTARAKHAND - INDIA
1604 NDA/MAL/H UNIVERSAL HARLEYS CLOTRINE CLOTRIMAZO 100MG UNIVERSAL CORPORATION KENYA VAGINAL 1.0X6.0 7/1/2009
DP/3151 CORPORATIO UGANDA 100 MG LE LIMITED -PLOT 13777 TABLETS PESSARY
N LTD LIMITED PESSARIES KIKUYU ROAD, KIKUYU STRIP
TOWN, PAST POST OFFICE
1605 NDA/MAL/H PT SANBE MEDVIN POLDAN PARACETAM 400MG + PT.CAPRIFARMINDO INDONESIA ORAL SOLID 1.0X25.0X 7/1/2014
DP/3152 FARMA PHARMA MIG OL + ASPIRIN 250MG + LABORATORIES- ORDINARY 4.0
LIMITED + CAFFEINE 65MG JI.INDUSTRI TABLETS TABLET
NO.8,KOMPLEKS INDUSTRI STRIP
CIMAREME DESA
CIMAREME,KEC
PADALARANG,KAB
BANDUNG
1606 NDA/MAL/H M.J TATA UGANDA CEFUROXI CEFUROXIME 750MG M.J BIOPHARM PVT LTD -- INDIA PARENTERAL 1.0X10.0 7/1/2011
DP/3153 BIOPHARM LIMITED ME-MJ L-7 MIDC INDUSTRIAL ORDINARY ML VIAL
PVT LTD AREA, DIST . RAIGAD , DRY VIALS
1607 NDA/MAL/H MEDREICH SURGIPHARM BIOFERON FERRIC 200MG/5 THE MADRAS INDIA ORAL LIQUID 1.0X200.0 7/1/2007
DP/3155 PLC (U) LIMITED AMMONIUM ML + PHARMACEUTICALS..-NO. ORDINARY ML
CITRATE + 10MG/5ML 137B, OLD SYRUPS BOTTLE
CYANOCOBAL + MAHABALIPURAM ROAD,
AMIN + FOLIC 750MCG/5 KARAPAKKAM, CHENNAI
ACID ML 600096 MEDREICH LTD
(UNIT III) -SURVEY 4/3
AVALAHALI ANJANAPURA
POST OFF KARNAKATA
BANGALORE 560 062
TEJKAMAL
PHARMACEUTICALSPVT.
1608 NDA/MAL/H PFIZER PHILLIPS BENYLIN PSEUDOEPHE 30MG + JOHNSON&JOHNSON PTY SOUTH ORAL SOLID 1.0X2.0X1 7/1/2008
DP/3156 LABORATORIE PHARMACEUTIC FOR COLDS DRINE HCL + 200MG LTD.-EDMS BPK241 MAIN AFRICA ORDINARY 0.0
S (PTY) ALS (UGANDA) IBUPROFEN ROAD /HOOFWEG TABLETS TABLET
LIMITED 241,RETREAT 7945,SOUTH STRIP
AFRICA
1609 NDA/MAL/H MJ TATA UGANDA GLIBEX-5 GLIBENCLAMI 5MG M.J BIOPHARM PVT LTD -- INDIA ORAL SOLID 1.0X10.0X 7/1/2012
DP/3158 BIOPHARM LIMITED DE L-7 MIDC INDUSTRIAL ORDINARY 10.0
PVT LTD AREA, DIST . RAIGAD , TABLETS TABLET
TALOJA , NAVI MUMBAI STRIP
1610 NDA/MAL/H SK AGE ABACUS LARTEM ARTEMETHER 80MG + SKANT HEALTH CARE LTD - INDIA ORAL SOLID 1.0X6.0 7/1/2015
DP/3159 EXPORTS PHARMA FORTE + 480MG 1802-1805 GIDC PHASE III ORDINARY TABLET
(AFRICA) LUMEFANTRI VAPI GUJARAT TABLETS BLISTER
LIMITED NE
1611 NDA/MAL/H ASTRA ASTRA PHARMA ASCILLIN AMPICILLIN 250MG ASTRA LIFE CARE (INDIA) INDIA ORAL SOLID 1.0X1000. 7/1/1997
DP/3161 PHARMA (U) (U) LIMITED PVT.LTD-PLOT NO. 57/P, ORDINARY 0
LIMITED SARKHEJ-BAVLA CAPSULES CAPSULE
HIGHWAY, POST RAJODA- CONTAIN
382220, TALUKA BAVLA, ER,1.0X10
AHMEDABAD INDIA 0.0X10.0
CAPSULE
BLISTER,1.
0X10.0X10
.0
CAPSULE
BLISTER
1612 NDA/MAL/H M.J TATA UGANDA KLAROL LORATADINE 10MG M.J BIOPHARM PVT LTD -- INDIA ORAL SOLID 1.0X3.0X1 7/1/2012
DP/3162 BIOPHARM LIMITED L-7 MIDC TALOJA DISTRICT ORDINARY 0.0
PST LTD RAIGAD 410208 NAVI TABLETS TABLET
MUMBAI BLISTER
1613 NDA/MAL/H BETA BETA SEPTRIN TRIMETHOPRI 40MG/5ML GLAXO WELLCOME EGYPT EGYPT ORAL LIQUID 1.0X50.0 7/1/1997
DP/3166 HEALTHCARE HEALTHCARE M+ + CO. S.A.E-CAIRO ORDINARY ML
UGANDA UGANDA SULPHAMETH 200MG/5 SUSPENSION BOTTLE,1.
LIMITED LIMITED OXAZOLE ML S 0X100.0
ML
BOTTLE
1614 NDA/MAL/H MJ TATA UGANDA MONAN- MEROPENEM 0.5G M.J BIOPHARM PVT LTD -- INDIA PARENTERAL 1.0X0.5 G 7/1/2010
DP/3167 BIOPHARM LIMITED 0.5G L-7 MIDC INDUSTRIAL ORDINARY VIAL
PVT LTD AREA, DIST . RAIGAD , DRY VIALS
1615 NDA/MAL/H M.J.BIOPHAR TATA UGANDA SPACOVIN DROTAVERIN 40MG M.J. BIOPHARM PVT. LTD- INDIA ORAL SOLID 1.0X10.0X 7/1/2012
DP/3175 M PVT LTD LIMITED E L-7, M.I.D.C. , TALOJA, ORDINARY 10.0
DISTRICT RAIGAD - 410 TABLETS TABLET
208 BLISTER
NAVI MUMBAI, INDIA
1616 NDA/MAL/H AFRICURE ROYAL PHARMA DOXYRONE- DOXYCYCLINE 100 AFRICURE INDIA ORAL SOLID 1.0X100.0 7/1/2005
DP/3176 PHARMACEUT 2011 LIMITED 100 HYDROCHLOR PHARMACEUTICALS ORDINARY CAPSULE
ICALS (INDIA) IDE (INDIA) PRIVATE LIMITED CAPSULES CONTAIN
PRIVATELIMIT (755793)-PLOT 9- ER,1.0X10
ED 12,DEWAN & SONS .0X10.0
INDUSTRIAL. AREA, CAPSULE
VEOOR,PALGHAR-401404. BLISTER
INDIA.
DP/3177 GROUP PHARMA CREAM ONE LTD-B-18,S.I.T.E KARACHI EXTERNAL G
(AFRICA) VALERATE 75700, PAKISTAN CREAMS TUBE,1.0X
LIMITED 5.0 G
TUBE
1618 NDA/MAL/H COSMOS LTD ASTRA PHARMA BENDURIC BENDROFLU 5MG COSMOS LTD.-RANGWE KENYA ORAL SOLID 1.0X10.0X 7/1/2005
DP/3178 (U) LIMITED TABLETS METHIAZIDE ROAD; OFF LUNGA LUNGA ORDINARY 10.0
NAIROBI BLISTER,1.
0X1000.0
TABLET
CONTAIN
ER
1619 NDA/MAL/H GOOD DAY PLANET SULPHUR SULPHUR 10%W/W KREMOINT PHARMA PVT INDIA TOPICAL 1.0X1.0X2 7/1/2013
DP/3179 PHARMACY PHARMACEUTIC OINTMENT LTD---B-8 ADDITIONAL EXTERNAL 5.0 G
LIMITED ALS UGANDA AMBERNATH MIDC OPP. OINTMENTS TUBE
LTD ANAND NAGAR POLICE
1620 NDA/MAL/H MJ TATA UGANDA LOFIN 500 METFORMIN 500MG M.J BIOPHARM PVT LTD -- INDIA ORAL SOLID 1.0X10.0X 7/1/2008
DP/3180 BIOPHARM LIMITED HYDROCHLOR L-7 MIDC INDUSTRIAL ORDINARY 10.0
PVT LTD IDE AREA, DIST . RAIGAD , FILM- TABLET
TALOJA , NAVI MUMBAI COATED BLISTER
TABLETS
1621 NDA/MAL/H CIPLA LTD QUALITY TADACIP 20 TADALAFIL 20MG CIPLA LTD-CIPLA LTD PLOT INDIA ORAL SOLID 1.0X4.0 7/1/2005
DP/3182 CHEMICALS LTD - NO L-139,VERNA IND ORDINARY TABLET
HUMAN ESTATE, VERNA GOA TABLETS BLISTER
INDIA
1622 NDA/MAL/H M.J TATA UGANDA MONAN MEROPENEM 1G M.J BIOPHARM PUT LTD -L- INDIA PARENTERAL 1.0X1.0 G 7/1/2008
DP/3184 BOPHARM LIMITED 7 MIDC INDUSTRIOL DIST ORDINARY VIAL
PUT LTD GAIDED TOLOJA DRY VIALS
1623 NDA/MAL/H CIPLA LTD QUALITY ERECTO - SILDENAFIL 100 MG CIPLA LIMITED PUNE- INDIA ORAL SOLID 1.0X1.0 7/1/2007
DP/3191 CHEMICALS LTD - 100 CITRATE MIDC, KURKUMBH ORDINARY TABLET
HUMAN DISTRICT PUNE 413802 FILM- BLISTER
COATED
TABLETS
1624 NDA/MAL/H MYLAN KIMSY MEDS ANZAVIR-R ATAZANAVIR 300 MG + MYLAN LABORATORIES INDIA ORAL SOLID 1.0X30.0 7/1/2013
DP/3192 LABORATORIE LTD + RITONAVIR 100 MG LTD--F-4,F-12 MALEGAON ORDINARY TABLET
STATE
1625 NDA/MAL/H CIPLA LTD QUALITY ERECTO- 50 SILDENAFIL 50MG CIPLA LIMITED PUNE- INDIA ORAL SOLID 1.0X1.0 7/1/2005
DP/3193 CHEMICALS LTD - CITRATE MIDC, KURKUMBH ORDINARY TABLET
HUMAN DISTRICT PUNE 413802 FILM- BLISTER
COATED
TABLETS
1626 NDA/MAL/H MEDLEY MEDVIN MOTINOR DOMPERIDO 10MG MEDLEY INDIA ORAL LIQUID 1.0X30.0 7/1/2000
DP/3196 PHARMACEUT PHARMA M NE PHARMACEUTICALS LTD- ORDINARY ML
ICALS LTD LIMITED PLOT NO.18 AND 19, SYRUPS BOTTLE
SURVEY NO.378/8 &
ESTATE, KACHIGAM,
DAMAN-396210 INDIA
1627 NDA/MAL/H ERIS LTD BENLE CONSULT TRIAM- TRIAMCINOL 40 MG/ML DENK PHARMA, GOLLSTR.,- GERMANY PARENTERAL 1.0X10.0X 7/1/2004
DP/3197 LIMITED DENK 40 ONE 1-D-845 529 TITTMONING ORDINARY 1.0 ML
INJECTION ACETONIDE GERMANY AMPOULES AMPOULE
1628 NDA/MAL/H GITTOES GITTOES AGOPEN- PHENOXYME 125MG/ML MILAN LABORATORIES INDIA ORAL LIQUID 1.0X1.0X1 7/1/2011
DP/3198 PHARMACEUT PHARMACEUTIC 125 THYL (INDIA ) PVT LTD-PLOT ORDINARY 00.0 ML
ICALS LIMITED ALS LIMITED PENICILLIN NO.63-67 & 87,JAWAHAR DRY BOTTLE
POTASSIUM CO.OP.INDUSTRIAL SUSPENSION
ESTATE LTD S/SYRUPS/D
KAMOTHE,PANVEL DIST. ROPS
THANE,MAHARASTRA-
410209,INDIA
1629 NDA/MAL/H MERCK PHILLIPS ISENTRESS RALTEGRAVIR 400MG ZHEIJIANG HUAHAI CHINA ORAL SOLID 1.0X60.0 7/1/2011
DP/3199 SHARP & PHARMACEUTIC PHARMACEUTICAL CO LTD ORDINARY TABLET
DOHME BV ALS (UGANDA) -ZHEIJIANG HUAHAI TABLETS CONTAIN
LIMITED PHARMACEUTICAL CO LTD ER
XUNQIAE LINHAI ZHIJIANG
1630 NDA/MAL/H LABORATORY HARLEYS LETRAX LEVAMISOLE 40MG LABORATORY & ALLIED KENYA ORAL SOLID 1.0X1000. 7/1/1997
DP/3200 AND ALLIED UGANDA HYDROCHLOR LTD--PLOT NO. 209/ ORDINARY 0 TABLET
LTD LIMITED IDE 10349, OPP. SAMEER TABLETS CONTAIN
BUSINESS PARK, ER,1.0X20
MOMBASA ROAD P.O. 0.0
BOX 42875, GPO 00100, TABLET
NAIROBI, KENYA CONTAIN
ER,1.0X25
.0X3.0
TABLET
BLISTER,1.
0X3.0
1631 NDA/MAL/H IPCA MEDVIN PRESARTAN- LOSARTAN 50MG IPCA LABORATORIES LTD- INDIA ORAL SOLID 1.0X2.0X1 7/1/2008
DP/3202 LABORATORIE PHARMA 50 PLOT NO. 255/1, ORDINARY 4.0
S LTD LIMITED VILLAGE ATHAL, FILM- TABLET
SILVASSA-396230, COATED BLISTER,1.
DADRA AND NAGAR TABLETS 0X3.0X10.
HAVELI, INDIA. 0 TABLET
BLISTER,1.
0X10.0X10
.0 TABLET
BLISTER
1632 NDA/MAL/H SERUM NORVIK TETANUS TETANUS 1500 I.U SERUM INSTITUTE OF INDIA PARENTERAL 1.0X50.0X 7/1/2013
DP/3203 INSTITUTE OF ENTERPRISES ANTITOXIN ANTITOXIN INDIA LTD-212/2 ORDINARY 1.0 ML
INDIA LTD. LIMITED HADAPSAR, PUNE, 411028, AMPOULES AMPOULE
INDIA (1 DOSE
AMPOULE
)
1633 NDA/MAL/H GLENMARK STAR RELCER GEL ALUMINIUM 6G+80MG+ GLENMARK INDIA ORAL LIQUID 1.0X180.0 7/1/2000
DP/3204 PHARMACEUT PHARMACEUTIC HYDROXIDE/ 100MG+40 PHARMACEUTICALS LTD- ORDINARY ML
ICAL LTD ALS LTD MAGNESIUM 0MG/5ML PLOT NO E -37, 39 ,D LIQUIDS BOTTLE,1.
HYDROXIDE/ 0X100.0
DIMETHICON ML
E/LIQUORICE BOTTLE
1634 NDA/MAL/H EAGLEVET MEDVIN AZIFAST- AZITHROMYCI 250MG IPCA LABORATORIES INDIA ORAL SOLID 1.0X10.0X 7/1/2007
DP/3205 UGANDA PHARMA 250 N LTD,PLOT NO. T-139 - ORDINARY 6.0
LIMITED LIMITED SEJAVTA, RATLAM-457 002 FILM- TABLET
(M.P.) INDIA COATED BLISTER
TABLETS
1635 NDA/MAL/H HEALTHCARE HEALTHCARE POSTINOR LEVONORGES 0.75MG GEDEON RICHTER PLC- HUNGARY ORAL SOLID 1.0X1.0X2 7/1/2010
DP/3206 LTD. LTD. 2 TREL 1103 BUDAPEST GYOMROI ORDINARY .0 TABLET
UT 19-21 TABLETS BLISTER
1636 NDA/MAL/H MODI MUNDI SURGIPHARM DILCONTIN CONTROLLED 90MG MODI MUNDIPHARMA INDIA ORAL SOLID 1.0X10.0X 7/1/2010
DP/3207 PHARMA PVT (U) LIMITED XL 90 RELEASE (PVT) LTD-MEERUT - RETARD 10.0
LTD TABLETS OF MUZAFFARNAGAR ROAD, FILM- TABLET
DILTIAZEM MODIPURAM, UTTAR COATED STRIP
HYDROCHLOR PRADESH ESTATE TABLETS
IDE
1637 NDA/MAL/H NIRMA LIFE PHARMA NIRFOL 1% PROPOFOL 1%W/V ACULIFE HEALTHCARE INDIA PARENTERAL 1.0X10.0X 7/1/2010
DP/3208 LIMITED. AFRICA LIMITED PVT. LTD-VILLAGE ORDINARY 1.0X20.0
SACHANA ,TALUKA - VIALS ML
VIRAMGAM , VIAL,1.0X
AHMEDABAD 382150 10.0X50.0
GUJARAT ML VIAL
1638 NDA/MAL/H CIPLA LTD. QUALITY CLOPIVAS CLOPIDOGREL 75MG CIPLA LTD--PLOT NO L- INDIA ORAL SOLID 10.0X10.0 7/1/2005
DP/3212 CHEMICALS LTD - 75MG BISULPHATE 139,VERNA IND ESTATE, ORDINARY TABLET
HUMAN VERNA GOA-403 INDIA TABLETS BLISTER,1.
0X10.0X10
.0 TABLET
BLISTER
1639 NDA/MAL/H MODI MUNDI SURGIPHARM INDICONTI INDAPAMIDE 1.5MG MODI MUNDIPHARMA INDIA ORAL SOLID 1.0X10.0X 7/1/2010
DP/3214 PHARMA PVT (U) LIMITED N PVT. LTD-MEERUT- ORDINARY 10.0
LTD MUZAFFARNAGAR ROAD, FILM- TABLET
MODIPURAM – 250110 COATED BLISTER
UTTAR PRADESH TABLETS
1640 NDA/MAL/H CIPLA LTD QUALITY SEROFLO- SALMETEROL 25MCG + CIPLA LTD-CIPLA LTD PLOT INDIA LUNG 1.0X120.0 7/1/2009
DP/3215 CHEMICALS LTD - 125MG XINAFOATE + 125MCG NO L-139,VERNA IND ADMINISTRA METERED
HUMAN FLUTICASONE ESTATE, VERNA GOA TION CFC- DOSE
PROPIONATE INDIA FREE CANNISTE
METERED- R
DOSE
INHALER
1641 NDA/MAL/H GITTOES GITTOES AGOPHENO CHLORAMPH 125MG/5 AGOG PHARMA LTD-PLOT INDIA ORAL LIQUID 1.0X100.0 7/1/1998
DP/3219 PHARMACEUT PHARMACEUTIC L ORAL ENICOL ML NO.33,SECTOR ORDINARY ML
ICALS LIMITED ALS LIMITED SUSPENSIO II,VASAI,TALUKA INDL CO- SUSPENSION BOTTLE
N OP ESTATE LTD,GAURAI S
E INDIA
1642 NDA/MAL/H CIPLA LTD QUALITY PYLO KIT LANSOPRAZO 30MG+500 CIPLA LIMITED PUNE- INDIA ORAL SOLID 1.0X7.0X1 7/1/2005
DP/3220 CHEMICALS LTD - LE+TINIDAZO MG+250 MIDC, KURKUMBH ORDINARY .0X6.0
HUMAN LE+CLARITHR MG DISTRICT PUNE 413802 FILM- TABLET
OMYCIN COATED BLISTER
TABLETS (BLISTER
CONTAINS
2
CAPSULES
AND 4
TABLETS)
1643 NDA/MAL/H KAMPALA KAMPALA KAM MULTI- MULTI- TIL HEALTHCARE PVT INDIA ORAL LIQUID 1.0X60.0 7/1/1997
DP/3224 PHARMACEUT PHARMACEUTIC FLUFED INGREDIENT INGREDIEN LIMITED-PLOT 100, WEST ORDINARY ML
ICAL AL INDUSTRIES ELIXIR T R-5, SOUTH, SRICITY SEZ, LIQUIDS BOTTLE
INDUSTRIES 1996 LIMITED CHERIVE9 (VI), DISTRICT:
(1996) LTD CHITOOR 517588
ANDHRA PRADESH-
1644 NDA/MAL/H LINCOLN METRO DIFLAME DICLOFENAC N/A LINCOLN INDIA TOPICAL 1.0X15.0 7/1/2010
DP/3225 PHARMACEUT PHARMACEUTIC DIETHYLAMIN PHARMACEUTICAL EXTERNAL G
ICALS LTD ALS LIMITED E + LINSEED LIMITED-TRIMAL ESTATE GELS AND TUBE,1.0X
OIL + METHYL KHATRAJ KOLOL,GUJARAT SOLS 30.0 G
SALICYLATE INDIA TUBE
MENTHOL
1645 NDA/MAL/H LINCOLN METRO FLUCOMOL PARACETAM 500MG/10 LINCOLN INDIA ORAL SOLID 1.0X2.0X1 7/1/2008
DP/3231 PHARMACEUT PHARMACEUTIC OL/PHENYLEP MG/15MG PHARMACEUTICAL ORDINARY 0.0
ICALS LTD ALS LIMITED HRINE /2MG LIMITED-TRIMAL ESTATE CAPSULES CAPSULE
HCL/DEXTRO KHATRAJ KOLOL,GUJARAT BLISTER,1.
METHORPHA INDIA 0X10.0X1.
N 0X10.0
HBR/CHLORP CAPSULE
HENIRAMINE BLISTER
MALEATE
1646 NDA/MAL/H LEBEN ANDYCO L-TRIM SULFAMETHO 400MG + LEBEN LABORATORIES PVT INDIA ORAL SOLID 1.0X10.0X 7/1/2016
DP/3232 LABORATORIE PHARMACY XAZOLE + 80MG LTD --L4 PHASEIII M.I.D.C ORDINARY 10.0
S PVT LTD (UGANDA) LTD TRIMETHOPRI AKOLA 444 104 TABLETS TABLET
M MAHARASHTRA BLISTER,1.
0X100.0X1
0.0
TABLET
BLISTER
1647 NDA/MAL/H SHOSAAN RENE WHITFIELD' BENZOIC 0.06G+0.03 NEM LABORATORIES PVT INDIA TOPICAL 1.0X20.0 7/1/1997
DP/3233 ASIC PACIFIC PHARMACY LTD S ACID + G LTD-133 VASAI RD(E) 401 EXTERNAL G TUBE
OINTMENT SALICYLIC 162 SB MARG. LOWER OINTMENTS
BP ACID PAREL MUMBAI
1648 NDA/MAL/H KAMPALA KAMPALA KAM COTRI CO- 480MG KAMPALA UGANDA ORAL SOLID 1.0X100.0 7/1/1997
DP/3236 PHARMACEUT PHARMACEUTIC TRIMOXAZOL PHARMACEUTICAL ORDINARY TABLET
ICAL AL INDUSTRIES E INDUSTRIES (1996) TABLETS CONTAIN
CONTAIN
ER,1.0X50
0.0
TABLET
CONTAIN
ER,1.0X10
1649 NDA/MAL/H LINCOLN METRO KONAZOL KETOCONAZO 2% W/W LINCOLN INDIA TOPICAL 1.0X15.0 7/1/2008
DP/3237 PHARMACEUT PHARMACEUTIC CREAM LE PHARMACEUTICAL EXTERNAL G TUBE
ICALS LTD ALS LIMITED LIMITED-TRIMAL ESTATE CREAMS
KHATRAJ KOLOL,GUJARAT
INDIA
1650 NDA/MAL/H LINCOLN METRO CLOTRILIN CLOTRIMAZO 1%W/W LINCOLN INDIA TOPICAL 1.0X20.0 7/1/2008
DP/3241 PHARMACEUT PHARMACEUTIC LE PHARMACEUTICALS LTD-- EXTERNAL G
ICALS LTD ALS LIMITED TRIMUL ESTATE AFER CREAMS TUBE,1.0X
VODSAR VILLAGE KHATJAT 15.0 G
382 721 GUJARAT VADSAR TUBE
GANDHINAGAR INDIA
1651 NDA/MAL/H UNI MEDICO SHREEJI UMICILLIN AMPICILLIN 250MG UNI MEDICOLABS.- 21-22 INDIA ORAL SOLID 1.0X10.0X 7/1/2015
DP/3244 LAB PHARMACEUTIC PHARMACITY SELAQUI ORDINARY 10.0
ALS LIMITED DEHRADUN 248197 CAPSULES CAPSULE
BLISTER
1652 NDA/MAL/H EGYPTIAN WIDE NYSTATIN NYSTATIN 100,000 EGYPTIAN EGYPT ORAL 1.0X30.0 7/1/2013
DP/3245 INTERNATION SPECTRUM ORAL I.U/ML INTERNATIONAL TOPICAL ML
AL ENTERPRISES DROPS PHARMACEUTICAL DROPS BOTTLE
PHARMACEUT (U) LIMITED INDUSTRIES COMPANY-
COMPANY
1653 NDA/MAL/H GITTOES GITTOES COMPOUN MAGNESIUM 370MG AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1.0X3.0X1 7/1/2000
DP/3246 PHARMACEUT PHARMACEUTIC D TRISILICATE NO.33,SECTOR ORDINARY 0.0
ICALS LIMITED ALS LIMITED MAGNESIU II,VASAI,TALUKA INDL CO- CHEWABLE TABLET
M OP ESTATE LTD,GAURAI TABLETS BLISTER,1.
TRISILICATE PADA,VASAI(E)DIST.THAN 0X1000.0
E INDIA TABLET
CONTAIN
ER,1.0X10
.0X10.0
TABLET
BLISTER
1654 NDA/MAL/H ATCO HARLEYS RUMAFEN IBUPROFEN 10%W/W ATCO LABS (PVT) LTD-B18 PAKISTAN ORAL 1.0X30.0 7/1/2005
DP/3248 LABORATORIE UGANDA GEL 10% S.I.T.E KARACHI, PAKISTAN TOPICAL G TUBE
S LTD LIMITED UNIT DOSE
GELS/SOLS
1655 NDA/MAL/H CADILA ABACUS LOSACAR-H LOSARTAN 50MG + CADILA HEALTHCARE INDIA ORAL SOLID 1.0X10.0X 7/1/2004
DP/3249 HEALTHCARE PHARMA POTASSIUM + 12.5MG LIMITED--KUNDAIM ORDINARY 10.0
LTD (AFRICA) HYDROCHLOR INDUSTRIAL ESTATE, PLOT TABLETS TABLET
LIMITED OTHIAZIDE NO. 203-213, BLISTER,1.
INDIA 0 TABLET
BLISTER
1656 NDA/MAL/H SCHERING SURGIPHARM UROGRAFI DIATRIZOIC 76%W/V SCHERING N.V, SA-SPAIN SPAIN PARENTERAL 1.0X20.0 7/1/1997
DP/3251 N.V.SA... (U) LIMITED N ACID ORDINARY ML VIAL
INFUSION
VIALS/BOTTL
ES
1657 NDA/MAL/H GALENTIC VITACARE PYLOOCAIN BETAMETHAS O.5 MG/G GALENTIC PHARMA( INDIA INDIA TOPICAL 1.0X1.0X3 7/1/2005
DP/3252 PHARMA LTD LIMITED ONE + + 1 MG/G ) PVT LTD-R-673,MIDC TTC EXTERNAL 0.0 G
PHENYLEPHRI + 25 MG/G RABALE THANE-BELAPUR OINTMENTS TUBE
NE + ROAD,NAVI
LIDOCAINE
1658 NDA/MAL/H VENUS AARON ROBOL DOXORUBICI 50MG/25 VENUS REMEDIES LTD, INDIA PARENTERAL 1.0X30.0 7/1/2009
DP/3254 REMEDIES PHARMACEUTIC N HCL ML UNIT II,-HILL TOP ORDINARY I ML VIAL
LIMITED ALS LTD INDUSTRIAL ESTATE, V VIALS
KALAN, BADDI -HP
1659 NDA/MAL/H GITTOES GITTOES SATISFIL-50 SILDENAFIL 50MG AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1.0X1.0X4 7/1/2011
DP/3255 PHARMACEUT PHARMACEUTIC CITRATE NO.33,SECTOR ORDINARY .0 TABLET
ICALS LIMITED ALS LIMITED II,VASAI,TALUKA INDL CO- TABLETS BLISTER
E INDIA
1660 NDA/MAL/H SHOSAAN RENE TIGBODER 0.05% NEM LABORATORIES PVT INDIA TOPICAL 1.0X3.0 G 7/1/1997
DP/3259 ASIC PACIFIC PHARMACY LTD M BETAMETHAS W/W + LTD-133 VASAI RD(E) 401 EXTERNAL TUBE,1.0X
ONE + 0.1% W/W 162 SB MARG. LOWER CREAMS 15.0 G
CHLOROCRES + 0.1% PAREL MUMBAI TUBE
OL + W/W + 1%
GENTAMICIN W/W + 1%
+ W/W
CLIOQUINOL
+
TOLNAFTATE
1661 NDA/MAL/H MYLAN KIMSY MEDS TENOFOVIR TENOFOVIR 300MG+20 MYLAN LABORATORIES INDIA ORAL SOLID 1.0X30.0 7/1/2008
DP/3261 LABORATORIE LTD DF + DF + 0MG+600 LTD--F-4,F-12 MALEGAON ORDINARY TABLET
S LIMITED EMTRICITA EMTRICITABI MG MIDC SINNAR NASHIK TABLETS BOTTLE
BINE + NE + 422113 MAHARASHTRA
EFAVIRENZ EFAVIRENZ STATE
MYLAN LABORATORIES
13 MIDCWALUJ
INDUSTRIAL AREA
AURANGABAD 431136
MAHARASTRA MYLAN
LABORATORIES LIMITED -
1662 NDA/MAL/H RENE RENE RENEGEL MAGNESIUM 250MG + RENE INDUSTRIES LTD- UGANDA ORAL SOLID 1.0X10.0X 7/1/2007
DP/3262 INDUSTRIES INDUSTRIES HYDROXIDE + 250MG PLOT 680, KAMULI ROAD, ORDINARY 10.0
LTD LIMITED ALUMINIUM KIREKA, P.O BOX 6034, CHEWABLE TABLET
HYDROXIDE KAMPALA COATED BLISTER
TABLETS
1663 NDA/MAL/H REGAL REGAL PHARMA TRIMEX SALBUTAMOL 2MG/5ML REGAL KENYA ORAL LIQUID 1.0X100.0 7/1/2009
DP/3263 PHARMACEUI (U) LTD MUCOLYTIC SULPHATE + + PHARMACEUTICALS LTD- ORDINARY ML
CALS LTD SYRUP BROMHEXINE 4MG/5ML BABA DOGO ROAD, SYRUPS BOTTLE
HYDROCHLOR + RAURAKA,NAIROBI,KENYA
IDE + 100MG/5
GUAIFENESIN ML
1664 NDA/MAL/H BETA BETA SALIMIA METHYL 5ML+25ML BETA HEALTHCARE KENYA TOPICAL 1.0X60.0 7/1/1997
DP/3266 HEALTHCARE HEALTHCARE LINIMENT SALICYLATE+T INTERNATIONAL LTD - - EXTERNAL ML
UGANDA UGANDA URPENTINE PLOT LIQUIDS BOTTLE,1.
LIMITED LIMITED OIL NO.209/6554,MOGADISHU 0X50.0 ML
ROAD,OFF LUNGA LUNGA BOTTLE
INDUSTRIAL AREA,
P.O.BOX 42569-001000
NAIROBI,KENYA
1665 NDA/MAL/H ASTRA ASTRA PHARMA FORTIFIED FORTIFIED 4000000 IU CSPC ZHONGNUO CHINA PARENTERAL 1.0X10.0 7/1/2001
DP/3270 PHARMA (UK) (U) LIMITED PROCAINE PROCAINE PHARMACEUTICAL ORDINARY VIAL
LTD PENICILLIN PENICILLIN (SHIJIAZHUANG)CO. LTD- DRY VIALS CARTON,1
NO. 88, YANGZI ROAD, .0X50.0
SHIJIAZHUANG CITY, VIAL
HEBEI CARTON
PROVINCE(WORKSHOP
406 AND 407)
1666 NDA/MAL/H KAMPALA KAMPALA BETASOL BETAMETHAS 0.1%W/W KAMPALA UGANDA TOPICAL 1.0X15.0 7/1/1997
DP/3273 PHARMACEUT PHARMACEUTIC CREAM ONE PHARMACEUTICAL EXTERNAL G
ICAL AL INDUSTRIES VALERATE INDUSTRIES (1996) CREAMS TUBE,1.0X
INDUSTRIES 1996 LIMITED LIMITED - -STRETCHER 30.0 G
LTD ROAD PLOT M444B TUBE
NTINDA KAMPALA
1667 NDA/MAL/H LINCOLN METRO MEFLIN- MEFENAMIC 500MG LINCOLN INDIA ORAL SOLID 1.0X10.0X 7/1/2010
DP/3275 PHARMACEUT PHARMACEUTIC 500 ACID PHARMACEUTICALS ORDINARY 10.0
ICALS LTD ALS LIMITED LIMITED -10, 12, 13, TABLETS TABLET
TRIMUL ESTATE, AFTER BLISTER
KHATRAJ CHOKADI,
KHATRAJ-382721,
GHANDHINAGAR,
GUJARAT, INDIA
1668 NDA/MAL/H HILTON HEALTHCARE TRANSAMI TRANEXAMIC 500MG HILTON PHARMA (PVT) PAKISTAN ORAL SOLID 1.0X2.0X1 7/1/2001
DP/3277 PHARMA LTD. N ACID LTD-PLOT 13 SECTOR 15 ORDINARY 0.0
(PVT) LTD CAPSULES KORANGI INDUSTRIAL CAPSULES CAPSULE
500MG AREA KARACHI BLISTER
1669 NDA/MAL/H PHARMA OMAB UGANDA TOPIDIC 2% SODIUM 20MG/G PHARMA INTERNATIONAL JORDAN TOPICAL 1.0X15.0 7/1/2007
DP/3278 INTERNATION LIMITED OINTMENT FUSIDATE CO.-AMMAN JORDAN EXTERNAL G TUBE
AL COMPANY PLANT OINTMENTS
AL-QARTAL MARKETING
DEPARTMENT
ALBUJAH COMPLEX,
ALJUBAIHA
1670 NDA/MAL/H ROYAL ABACUS HAEMOFOR MULTI- MULTI- MILAN LABORATORIES INDIA ORAL LIQUID 1.0X90.0 7/1/1997
DP/3279 GROUP PHARMA TE SYRUP INGREDIENT INGREDIEN (INDIA ) PVT LTD-PLOT NO ORDINARY ML
(AFRICA) T 63/67/87 J.C.I.E LTD SYRUPS BOTTLE,1.
LIMITED KAMOTHE PANVER, NAVI 0X250.0
MUMBAI,INDIA BAROQUE ML
PHARMACEUTICALS PVT BOTTLE,1.
LTD --S.NO.192/2 & 0X200.0
S.NO.192/2 &3 SOKHADA- ML
388 620 KHAMBHAT. DIST. BOTTLE
ANAND GUJARAT INDIA
1671 NDA/MAL/H MACK SHURIK LTD KOFF-GO PHENYLEPHRI 5MG/5ML TORQUE INDIA ORAL LIQUID 1.0X1.0X1 7/1/2009
DP/3282 BROWN NE HCL + + PHARMACEUTICALS (P) ORDINARY 00.0 ML
PHARMECEUT CHLORPHENI 2MG/5ML LTD-P.O.DAPPAR VILLISS SYRUPS BOTTLE
ICALS PVT LTD RAMINE +
MALEATE + 10MG/5ML
DEXTROMET
HORPHAN
1672 NDA/MAL/H LABORATORY HARLEYS CHALEATE CHLORPHENI 4MG LABORATORY & ALLIED KENYA ORAL SOLID 1.0X10.0X 7/1/1997
DP/3284 &ALLIED LTD UGANDA RAMINE LTD--PLOT NO. 209/ ORDINARY 10.0
LIMITED MALEATE 10349, OPP. SAMEER TABLETS TABLET
BUSINESS PARK, BLISTER,1.
MOMBASA ROAD P.O. 0X1000.0
ER
1673 NDA/MAL/H GLAXOSMITH UNITED AMOXIL AMOXYCILLIN 250MG/5 GLAXO WELLCOME FRANCE ORAL LIQUID 1.0X100.0 7/1/1997
DP/3285 KLINE HEALTHCARE FORTE ML PRODUCTION.-ZONE ORDINARY ML
PHARMACEUT DISTRIBUTORS 250MG/5M INDUSTRIELLE DE LA DRY BOTTLE
ICAL KENYA LTD L PEYENNIERE 53100 SUSPENSION
LTD MAYENNE, FRANCE S/SYRUPS/D
ROPS
1674 NDA/MAL/H CIPLA QUALITY LOMAC-20 OMEPRAZOLE 20 MG CIPLA LTD --PLOT NO 9, 10 INDIA ORAL SOLID 1.0X10.0X 7/1/2009
DP/3286 LIMITED CHEMICALS LTD - & 15, PHARMA ZONE, ORDINARY 10.0
HUMAN PHASE II, CAPSULES CAPSULE
SECTOR III, INDORE BLISTER
SPECIAL ECONOMIC ZONE,
775, INDIA
1675 NDA/MAL/H REGAL REGAL PHARMA DELASED DIPHENHYDR 14MG+135 REGAL KENYA ORAL LIQUID 1.0X100.0 7/1/1997
DP/3288 PHARMACEUT (U) LTD CHESTY AMINE HCL MG+57MG PHARMACEUTICALS LTD- ORDINARY ML
ICALS LTD COUGHS BP+AMMONI +1.1MG/5 BABA DOGO ROAD, SYRUPS BOTTLE,1.
SYRUP UM ML RAURAKA,NAIROBI,KENYA 0X60.0 ML
CHLORIDE BOTTLE
BP+SODIUM
CITRATE
BP+MENTHOL
BP
1676 NDA/MAL/H GLENMARK STAR CANDID CLOTRIMAZO 1%W/W GLENMARK INDIA TOPICAL 1.0X30.0 7/1/1999
DP/3289 PHARMACEUT PHARMACEUTIC DUSTING LE PHARMACEUTICALS LTD- EXTERNAL G
ICAL LTD ALS LTD POWDER PLOT NO E -37, 39 ,D DUSTING BOTTLE,1.
POWDERS 0X100.0 G
BOTTLE
1677 NDA/MAL/H GLENMARK STAR FINTOP BUTENAFINE 1%W/W GLENMARK INDIA TOPICAL 1.0X15.0 7/1/2003
DP/3291 PHARMACEUT PHARMACEUTIC HCL PHARMACEUTICALS LTD- EXTERNAL G TUBE
ICALS LTD ALS LTD PLOT NO E -37, 39 ,D CREAMS
1678 NDA/MAL/H REGAL REGAL PHARMA DELASED DIPHENHYDR 7MG+28.5 REGAL KENYA ORAL LIQUID 1.0X100.0 7/1/1997
DP/3292 PHARMACEUT (U) LTD PAEDIATRIC AMINE MG+0.55M PHARMACEUTICALS LTD- ORDINARY ML
ICALS LTD SYRUP HYDROCHLOR G BABA DOGO ROAD, SYRUPS BOTTLE,1.
IDE+SODIUM RAURAKA,NAIROBI,KENYA 0X60.0 ML
CITRATE+ME BOTTLE
NTHOL
1679 NDA/MAL/H SANDOZ SURGIPHARM BINOZYT AZITHROMYCI 200MG/5 SC SANDOZ SRL-LIVEZENI ROMANIA ORAL LIQUID 1.0X15.0 7/1/2003
DP/3293 GMBH C/O (U) LIMITED 200MG/5M N ML 7A STR. TARGU MURES ORDINARY ML
NOVARTIS L MONOHYDRA 540472 DRY BOTTLE
PHARMA TE SUSPENSION
SERVICES. S/SYRUPS/D
ROPS
1680 NDA/MAL/H WIN- SURGIPHARM URGENDOL TRAMADOL 50 MG WIN- MEDICARE LTD- INDIA ORAL SOLID 1.0X10.0X 7/1/2004
DP/3294 MEDICARE (U) LIMITED CAPSULES HYDROCHLOR MODIPURAM -250 ORDINARY 10.0
LTD IDE 110,UTTAR PRAADESH, CAPSULES CAPSULE
INDIA. BLISTER
1681 NDA/MAL/H GLENMARK STAR GLEVATE CLOBETASOL 0.05%W/W GLENMARK INDIA TOPICAL 1.0X15.0 7/1/2008
DP/3295 PHARMACEUT PHARMACEUTIC PHARMACEUTICALS LTD- EXTERNAL G TUBE
ICALS LTD ALS LTD PLOT NO E -37, 39 ,D CREAMS
1682 NDA/MAL/H MYLAN KIMSY MEDS LOPINAVIR LOPINAVIR / 100MG / MYLAN LABORATORIES INDIA ORAL SOLID 1.0X120.0 7/1/2011
DP/3296 PHARMACEUT LTD / RITONAVIR 25MG LTD--F-4,F-12 MALEGAON ORDINARY TABLET
ICAL PRIVATE RITONAVIR MIDC SINNAR NASHIK TABLETS CONTAIN
LIMITED, 422113 MAHARASHTRA ER,1.0X60
INDIA STATE .0 TABLET
CONTAIN
ER
1683 NDA/MAL/H LINCOLN METRO NEPIN-SR- NIFEDIPINE 20MG LINCOLN INDIA ORAL SOLID 1.0X3.0X1 7/1/2011
DP/3297 PHARMACEUT PHARMACEUTIC 20 PHARMACEUTICALS RETARD 0.0
ICALS LTD ALS LIMITED LIMITED-10, 12, 13, FILM- TABLET
TRIMUL ESTATE, AFTER COATED BLISTER,1.
VADSCAR VILLAGE, NEAR TABLETS 0X10.0X10
KHATRAJ CHOKADI, .0 TABLET
KHATRAJ-382721, BLISTER
GHANDHINAGAR,
GUJARAT, INDIA
1684 NDA/MAL/H TATA TATA UGANDA GENTAMICI GENTAMICIN 40MG/ML GLAND PHARMA LIMITED ;- INDIA PARENTERAL 1.0X10.0X 7/1/2004
DP/3298 UGANDA LIMITED N RANGA REDDY DISTRICT, ORDINARY 2.0 ML
LIMITED INJECTION HYDERABAD, ANDHRA AMPOULES AMPOULE
PRADESH GLAND
PHARMA LTD-PLOT NO. 42
TO 52, SY NO. 166, 171,
172 & 177, TSIIC, PHASE
III, PASHAMYLARAM (V)
DISTRICT 502307,
TELANGANA STATE
1685 NDA/MAL/H MEDICAL KARURI MUCOSOL CARBOCISTEI 125 MG/5 MEDICAL UNION PHARMA EGYPT ORAL LIQUID 1.0X120.0 7/1/2003
DP/3300 UNION PHARMACEUTIC PEDIATRIC NE ML .CO-ABU-SULTAN ISMAILIA ORDINARY ML
PHARMACEUT ALS LTD. SYRUP EGYPT SYRUPS BOTTLE
ICALS
1686 NDA/MAL/H CIPLA LTD QUALITY AMOXICILLI AMOXICILLIN 125MG/5 OKASA PVT LTD-346 INDIA ORAL LIQUID 1.0X100.0 7/1/2009
DP/3302 CHEMICALS LTD - N ORAL ML KUNDAIM INDUSTRIAL ORDINARY ML
HUMAN SUSPENSIO ESTATE GOA, 403115 DRY BOTTLE
N SUSPENSION
S/SYRUPS/D
ROPS
1687 NDA/MAL/H REMEDICA GOODMAN FELEXIN CEFALEXIN 250MG REMEDICA LIMITED - CYPRUS ORAL SOLID 1.0X10.0X 7/1/2007
DP/3304 LTD INTERNATIONAL MONOHYDRA AHARNON STREET, ORDINARY 10.0
LTD TE LIMASSOL INDUSTRIAL CAPSULES CAPSULE
CYPRUS 3056, CYPRUS
1688 NDA/MAL/H UMEDICA VITACARE CLORIFORT CLOTRIMAZO 100MG UMEDICA LABORATORIES INDIA VAGINAL 1.0X6.0 7/1/2002
DP/3309 LABORATORIE LIMITED VAGINAL LE PVT LTD-PLOT NO. 221, TABLETS PESSARY
S PVT LTD TABLETS 2ND PHASE, GIDC, VAPI STRIP
396195, GUJARAT. INDIA.
1689 NDA/MAL/H ALKEM ABACUS GEMFOS RISEDRONAT 35MG ALKEM LABORATORIES INDIA ORAL SOLID 1.0X4.0 7/1/2011
DP/3310 LABORATORIE PHARMA E SODIUM LTD .,.-VILLAGE THANA ORDINARY TABLET
S LIMITED (AFRICA) BADDI DIST-SOLAN TEHSIL TABLETS BLISTER
LIMITED NALAGARH HIMACHAL
PRADESH 173205
1690 NDA/MAL/H TORRENT KARURI TIDOMET CO- 25MG/250 TORRENT INDIA ORAL SOLID 1.0X10.0X 7/1/2004
DP/3312 PHARAMACE PHARMACEUTIC FORTE CARELDOPA MG PHARMACEUTICAL LTD- ORDINARY 10.0
AD-382721
1691 NDA/MAL/H SUN STAR SILVEREX SILVER 10MG/G+1 SUN PHARMACEUTICALS INDIA TOPICAL 1.0X250.0 7/1/2004
DP/3314 PHARMACEUT PHARMACEUTIC SULFADIAZIN 0MG/G IND. LTD-B-2,MADAKAI EXTERNAL G
ICAL ALS LTD E+ INDUSTRIAL ESTATE, CREAMS TUBE,1.0X
INDUSTRIES CHLORHEXIDI PONDA,GOA-403404, 25.0 G
LIMITED NE INDIA TUBE,1.0X
GLUCONATE 10.0 G
TUBE
1692 NDA/MAL/H GITTOES GITTOES ERO-250 ERYTHROMYC 250MG AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1.0X10.0X 7/1/2003
DP/3315 PHARMACEUT PHARMACEUTIC TABLETS IN STEARATE NO.33,SECTOR ORDINARY 10.0
E INDIA TABLET
CONTAIN
ER
1693 NDA/MAL/H SPARSH BIO- ABACUS SPAMOX AMOXYCILLIN 125MG/5 SPARSH BIO-TECH LTD- INDIA ORAL LIQUID 1.0X100.0 7/1/1998
DP/3316 TECH PVT LTD PHARMA TRIHYDRATE ML PLOT NO.1 SURVEY ORDINARY ML
(AFRICA) NO.242/234/244, VILLAGE DRY BOTTLE
LIMITED LAKHABARAD, JAMNAGAR- SUSPENSION
361006 S/SYRUPS/D
ROPS
1694 NDA/MAL/H RENE RENE RENETRIM CO- 480MG RENE INDUSTRIES LTD- UGANDA ORAL SOLID 1.0X1000. 7/1/2000
DP/3318 INDUSTRIES INDUSTRIES TABLETS TRIMOXAZOL PLOT 680, KAMULI ROAD, ORDINARY 0 TABLET
LTD LIMITED E KIREKA, P.O BOX 6034, TABLETS CONTAIN
KAMPALA ER
1695 NDA/MAL/H MEGA ABACUS FERROTON FERROUS 162MG MEGA LIFESCIENCES LTD.- THAILAND ORAL SOLID 1.0X5.0X1 7/1/2005
DP/3319 LIFESCIENCES PHARMA E CAPSULES FUMERATE+F +0.75MG 384 PATTANA 3 ROAD ORDINARY 0.0
(AUSTRALIA) (AFRICA) OLIC +7.5MCG BANGPOO INDUSTRIAL CAPSULES CAPSULE
PTY LTD LIMITED ACID+VITAMI ESTATE SUMUTPRAKAN BLISTER
N B12
1696 NDA/MAL/H LINCOLN METRO DERMOLIN- CLOBETASOL+ 0.05%W/W LINCOLN INDIA TOPICAL 1.0X15.0 7/1/2008
DP/3321 PHARMACEUT PHARMACEUTIC GM GENTAMICIN +0.1%W/W PHARMACEUTICALS EXTERNAL G TUBE
ICALS LTD ALS LIMITED +MICONAZOL +2%W/W LIMITED-10, 12, 13, CREAMS
E TRIMUL ESTATE, AFTER
KHATRAJ CHOKADI,
KHATRAJ-382721,
GHANDHINAGAR,
GUJARAT, INDIA
1697 NDA/MAL/H AUROBINDO GITTOES NEVIRAPIN NEVIRAPINE 50MG AUROBINDO PHARMA INDIA ORAL SOLID 1.0X30.0 7/1/2012
DP/3322 M PHARMA PHARMACEUTIC E LTD, UNIT III -SURVEY NO. ORDINARY TABLET
LIMITED ALS LIMITED 313, 314 BACHUPALLY TABLETS CONTAIN
(VILLAGE) ER
QUTHUBULLAPUR
HYDERABAD ANDHRA
PRADESH 500090
1698 NDA/MAL/H GITTOES GITTOES BENZYLPEN BENZYLPENIC 1 MU CSPC ZHONGNUO CHINA PARENTERAL 1.0X50.0X 7/1/2001
DP/3328 PHARMACEUT PHARMACEUTIC ICILLIN ILLIN PHARMACEUTICAL ORDINARY 1.0 MU
ICALS LIMITED ALS LIMITED INJECTION (SCIJIAZHUANG) CO. LTD DRY VIALS VIAL,1.0X
WORKSHOP -NO. 88 10.0X1.0
YANGZI ROAD, MU VIAL
SHIJIAZHUANG CITY,
WORKSHOP 406 AND 407
1699 NDA/MAL/H NORVATIS LABOREX BETOPTIC BETAXOLOL O.5%W/V ALCON COUVREUR NV- BELGIUM OPHTHALMI 1.0X5.0 7/1/1997
DP/3331 PHARMA AG- UGANDA RIJKSWEG 14, B-2870 C DROPS ML VIAL
SWITZERLAN LIMITED PUURS BELGIUM
D
1700 NDA/MAL/H CIPLA LTD. QUALITY NOVACLAV- AMOXICILLIN 500 MG + MEDISPRAY INDIA ORAL SOLID 1.0X4.0X5 7/1/2009
DP/3333 CHEMICALS LTD - 625 + 125 MG LABORATORIES PVT ORDINARY .0 TABLET
HUMAN CLAVULANAT LTD,UNIT II-368-348 TABLETS BLISTER
E POTASSIUM KUNDAIM INDUSTRIAL
ESTATE,KUNDAIM GOA -
403115,INDIA
1701 NDA/MAL/H UNICHEM PHILLIPS MYCLAV AMOXICILLIN 250 MG + UNICHEM LABORATORIES INDIA ORAL SOLID 1.0X2.0X1 7/1/2005
DP/3334 LABORATORIE PHARMACEUTIC 375 + 125 MG LIMITED UNIT II-VILLAGE ORDINARY 0.0
S LTD ALS (UGANDA) CLAVULANIC BHATAULI KALAN BADDI FILM- TABLET
LIMITED ACID DIST SOLAN HIMACHAL COATED STRIP,1.0X
PRADESH 173 205 TABLETS 10.0X6.0
TABLET
STRIP
1702 NDA/MAL/H REGAL REGAL PHARMA MEDIVEN- BETAMETHAS 0.1%W/W REGAL KENYA TOPICAL 1.0X15.0 7/1/1997
DP/3343 PHARMACEUT (U) LTD CREAM ONE PHARMACEUTICALS LTD- EXTERNAL G TUBE
ICALS LTD VALERATE BABA DOGO ROAD, CREAMS
1703 NDA/MAL/H ASTRA ASTRA PHARMA PAINOL-P PARACETAM 650MG + ASTRA LIFE CARE (INDIA) INDIA ORAL SOLID 1.0X25.0X 7/1/2010
DP/3345 PHARMACY (U) LIMITED OL + 50MG PVT.LTD-PLOT NO. 57/P, ORDINARY 4.0
(U) PVT LTD CAFFEINE SARKHEJ-BAVLA TABLETS TABLET
HIGHWAY, POST RAJODA- STRIP
AHMEDABAD INDIA
1704 NDA/MAL/H WOCKHARDT STAR ZEDEX BROMHEXINE 8MG+100 WOCKHARDT LIMITED -- INDIA ORAL LIQUID 1.0X100.0 7/1/1997
DP/3346 LTD PHARMACEUTIC +AMMONIU MG+5MG+ PLOT 57 VILLAGE ORDINARY ML
ALS LTD M CHLORIDE+ 10MG KUNJHAL, JHAMAJRI, SYRUPS BOTTLE
MENTHOL + BAROTIWALA, BADDI,
DEXTROMET TEHSIL-NALAGARH,
HORPHAN DISTRICT SOLAN, 174103
HIMACHAL PRADESH,
INDIA
1705 NDA/MAL/H REGAL REGAL PHARMA UNIPEN PHENOXYME 250MG REGAL KENYA ORAL SOLID 1.0X1000. 7/1/1997
DP/3347 PHARMACEUI (U) LTD TABLETS THYLPENICILL PHARMACEUTICALS LTD- ORDINARY 0 TABLET
CALS LTD IN BABA DOGO ROAD, TABLETS CONTAIN
RAURAKA,NAIROBI,KENYA ER,1.0X10
.0X10.0
TABLET
BLISTER
1706 NDA/MAL/H VENUS HARLEYS PIMCEF CEFEPIME 1G VENUS REMEDIES LTD.- INDIA PARENTERAL 1.0X20.0 7/1/2007
DP/3348 REMEDIES UGANDA USP UNIT 11 HOLL TOP ORDINARY ML VIAL
LTD LIMITED INDUSTRIAL ESTATE DRY VIALS
JHARMAJRI
1707 NDA/MAL/H LINCOLN METRO OMLINK-20 OMEPRAZOLE 20MG LINCOLN INDIA ORAL SOLID 1.0X10.0X 7/1/2011
ICALS LTD ALS LIMITED LIMITED-10, 12, 13, ENTERIC- CAPSULE
VADSCAR VILLAGE, NEAR CAPSULES
KHATRAJ CHOKADI,
KHATRAJ-382721,
GHANDHINAGAR,
GUJARAT, INDIA
1708 NDA/MAL/H REGAL REGAL PHARMA MEDIVEN BETAMETHAS 0.1%W/W REGAL KENYA TOPICAL 1.0X15.0 7/1/1997
DP/3354 PHARMACEUT (U) LTD OINTMENT ONE PHARMACEUTICALS LTD- EXTERNAL G TUBE
ICALS LTD VALERATE BABA DOGO ROAD, OINTMENTS
1709 NDA/MAL/H CADILA ABACUS ZYCEL-100 CELECOXIB 100MG CADILA HEALTHCARE INDIA ORAL SOLID 10.0X10.0 7/1/2001
DP/3356 HEALTH CARE PHARMA CAPSULES LIMITED--KUNDAIM ORDINARY CAPSULE
LIMITED (AFRICA) INDUSTRIAL ESTATE, PLOT CAPSULES BLISTER
LIMITED NO. 203-213,
INDIA
1710 NDA/MAL/H CENTAUR GITTOES ESOREST 20 ESOMEPRAZO 20MG CENTAUR INDIA ORAL SOLID 1.0X10.0X 7/1/2008
DP/3357 PHARMACEUT PHARMACEUTIC LE PHARMACEUTICALS PVT ORDINARY 10.0
ICALS LTD ALS LIMITED L.T.D.-CENTAUR HOUSE ENTERIC- TABLET
NEAR COATED BLISTER
TABLETS
1711 NDA/MAL/H SWISS SHREEJI ARTI ARTEMETHER 80MG/ML SWISS PARENTERALS LTD- INDIA PARENTERAL 1.0X6.0X1 7/1/2011
DP/3359 PARENTERALS PHARMACEUTIC 809 KERALA IND ESTATE ORDINARY I .0 ML
LTD ALS LIMITED GIDC NEAR BAVLA DIST M AMPOULE
AHMEDABAD 382220 AMPOULES
GUJARAT INDIA
1712 NDA/MAL/H CENTAUR GITTOES ESOREST 40 ESOMEPRAZO 40MG CENTAUR INDIA ORAL SOLID 1.0X10.0X 7/1/2008
DP/3364 PHARMACEUT PHARMACEUTIC LE PHARMACEUTICALS PVT ORDINARY 10.0
ICALS LTD ALS LIMITED L.T.D.-CENTAUR HOUSE ENTERIC- TABLET
NEAR COATED BLISTER
TABLETS
1713 NDA/MAL/H ASTRA LIFE ASTRA PHARMA DIAS GLIBENCLAMI 5MG ASTRA LIFE CARE(INDIA) INDIA ORAL SOLID 1.0X10.0X 7/1/2011
DP/3366 CARE (INDIA) (U) LIMITED DE PVT LTD-57/P, POJODA, ORDINARY 10.0
PVT LTD 382220, BOVIA, TABLETS TABLET
AHMEDOBAD, INDIA BLISTER
1714 NDA/MAL/H GITTOES GITTOES AGOMOL PARACETAM 125 AGOG PHARMA LTD-PLOT INDIA ORAL LIQUID 1.0X60.0 7/1/2000
DP/3367 PHARMACEUT PHARMACEUTIC SUSPENSIO OL MG/5ML NO. 33, SECTOR II, VASAI, ORDINARY ML
ICALS LIMITED ALS LIMITED N TALUKA INDL. SUSPENSION BOTTLE,1.
S 0X100.0
ML
BOTTLE
1715 NDA/MAL/H PFIZER LABOREX VIAGRA SILDENAFIL 50MG PFIZER PGM -AMBROISE FRANCE ORAL SOLID 1.0X12.0 7/1/1998
DP/3368 LABORATORIE UGANDA 50MG ZONE INDUSTRIELLE 29 ORDINARY TABLET
S (PTY) LTD LIMITED ROUTE DES INDUSTRIES TABLETS BLISTER,1.
37530 POCE SUR CISSE 0X8.0
TABLET
BLISTER,1.
0X4.0
TABLET
BLISTER
1716 NDA/MAL/H LINCOLN METRO AZILIN-500 AZITHROMYCI 500MG LINCOLN INDIA ORAL SOLID 1.0X10.0X 7/1/2008
ICALS LTD ALS LIMITED LIMITED-10, 12, 13, FILM- TABLET
KHATRAJ CHOKADI,
KHATRAJ-382721,
GHANDHINAGAR,
GUJARAT, INDIA
1717 NDA/MAL/H RENE RENE DERMOREN GRISEOFULVI 500MG RENE INDUSTRIES LTD- UGANDA ORAL SOLID 1.0X10.0X 7/1/2009
DP/3370 INDUSTRIES INDUSTRIES 500 N PLOT 680, KAMULI ROAD, ORDINARY 10.0
LIMITED LIMITED KIREKA, P.O BOX 6034, TABLETS TABLET
KAMPALA BLISTER
1718 NDA/MAL/H S K AGE ABACUS MUCOLEX AMBROXOL 30 S KANT HEALTHCARE LTD- INDIA ORAL LIQUID 1.0X100.0 7/1/2005
DP/3372 EXPORTS PHARMA HYDROCHLOR MG/5ML + 1802-1805 GIDC PHASE III ORDINARY ML
(AFRICA) IDE + 1 MG/5ML VAPI 396 195 SYRUPS BOTTLE
LIMITED SALBUTAMOL + 50
SULPHATE + MG/5ML +
GUAIFENESIN 0.5
+ MENTHOL MG/5ML
1719 NDA/MAL/H UNICHEM PHILLIPS MYCLAV AMOXILLICIN 500MG/12 UNICHEM LABORATORIES INDIA ORAL SOLID 1.0X2.0X7 7/1/2005
DP/3373 LABORATORIE PHARMACEUTIC 625 /CLAVULANA 5MG LIMITED UNIT II-VILLAGE ORDINARY .0 TABLET
S LTD ALS (UGANDA) TE BHATAULI KALAN BADDI FILM- STRIP,1.0X
LIMITED DIST SOLAN HIMACHAL COATED 10.0X6.0
PRADESH 173 205 TABLETS TABLET
STRIP
1720 NDA/MAL/H COSMOS ASTRA PHARMA ZITHROX AZITHROMYCI 250MG COSMOS LTD.-RANGWE KENYA ORAL SOLID 1.0X1.0X6 7/1/2008
DP/3374 LIMITED (U) LIMITED 250MG N ROAD; OFF LUNGA LUNGA ORDINARY .0 TABLET
ROAD. P.O BOX 414 33, FILM- BLISTER
NAIROBI COATED
TABLETS
1721 NDA/MAL/H GITTOES GITTOES AMILINE AMITRIPTYLI 25 MG AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1.0X1000. 7/1/2011
DP/3377 PHARMACEUT PHARMACEUTIC NE NO.33,SECTOR ORDINARY 0 TABLET
E INDIA TABLET
BLISTER,1.
0X100.0X1
0.0
TABLET
BLISTER
1722 NDA/MAL/H GITTOES GITTOES CHLOZINE CHLORPROM 100MG AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1.0X10.0X 7/1/2011
DP/3378 PHARMACEUT PHARMACEUTIC TABLETS AZINE NO. 33, SECTOR II, VASAI, ORDINARY 10.0
COATED BLISTER,1.
TABLETS 0X1000.0
TABLET
CONTAIN
ER
1723 NDA/MAL/H EGYPTIAN WIDE EPIFASI HUMAN 5000I.U EGYPTIAN EGYPT PARENTERAL 1.0X2.0 7/1/2011
DP/3379 INTERNATION SPECTRUM CHORIONIC INTERNATIONAL ORDINARY AMPOULE
AL ENTERPRISES GONADOTRO PHARMACEUTICAL AMPOULES CARTON
PHARMACEUT (U) LIMITED PIN INDUSTRIES COMPANY-
COMPANY
1724 NDA/MAL/H PHARMEDIC HEALTHCARE MALASAN ARTEMETHER 80MG/ML PHARMEDIC PAKISTAN PARENTERAL 1.0X5.0X1 7/1/2004
DP/3380 LABORATORIE LTD. LABORATORIES (PVT) LTD- ORDINARY .0 ML
S(PVT) 16KM, MULTAN ROAD, AMPOULES AMPOULE
LIMITED LAHORE – PAKISTAN
1725 NDA/MAL/H GITTOES GITTOES AGOFEN IBUPROFEN 100MG/5 AGOG PHARMA LTD-PLOT INDIA ORAL LIQUID 1.0X1.0X6 7/1/2010
DP/3382 PHARMACEUT PHARMACEUTIC SUSPENSIO ML NO.33,SECTOR ORDINARY 0.0 ML
ICALS LIMITED ALS LIMITED N II,VASAI,TALUKA INDL CO- SUSPENSION BOTTLE,1.
OP ESTATE LTD,GAURAI S 0X1.0X100
PADA,VASAI(E)DIST.THAN .0 ML
E INDIA BOTTLE
1726 NDA/MAL/H GITTOES GITTOES ZEPIN-200 CARBAMAZEP 200 MG AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1.0X100.0 7/1/2010
DP/3383 PHARMACEUT PHARMACEUTIC INE NO. 33, SECTOR II, VASAI, ORDINARY X10.0
BLISTER,1.
0X1000.0
TABLET
CONTAIN
ER,1.0X10
.0X10.0
TABLET
BLISTER
1727 NDA/MAL/H GLAXOSMITH UNITED PROXIMEX CEFUROXIME 250MG GLAXOSMITHKLINE UK UNITED ORAL SOLID 1.0X1.0X1 7/1/2007
DP/3384 KLINE HEALTHCARE A 250MG AXETIL LTD-HARMIRE RD KINGDOM ORDINARY 0.0
PHARMACEUT DISTRIBUTORS BARNARD CASTLE FILM- TABLET
ICAL KENYA LTD DURHAM, DL12DT UNITED COATED BLISTER
LTD TABLETS
1728 NDA/MAL/H BLUE CROSS STAR MEFTAL-P- MEFENAMIC 100MG/5 BLUE CROSS INDIA ORAL LIQUID 1.0X60.0 7/1/2007
DP/3385 LABORATORIE PHARMACEUTIC SUSPENSIO ACID ML LABORATORIES LTD-L-17, ORDINARY ML
S LTD ALS LTD N VERNA INDUSTRIAL SUSPENSION BOTTLE
ESTATE,VERNA GOA- S
403722
1729 NDA/MAL/H GLAXOSMITH UNITED PROXIMEX CEFUROXIME 500MG GLAXOSMITHKLINE UK UNITED ORAL SOLID 1.0X1.0X1 7/1/2007
DP/3387 KLINE HEALTHCARE A 500MG AXETIL LTD-HARMIRE RD KINGDOM ORDINARY 0.0
PHARMACEUT DISTRIBUTORS BARNARD CASTLE FILM- TABLET
ICAL KENYA LTD DURHAM, DL12DT UNITED COATED BLISTER
LTD TABLETS
1730 NDA/MAL/H BAYER SURGIPHARM CLARINASE LORATADINE 5MG + SCHERING PLOUGH LABO BELGIUM ORAL SOLID 1.0X2.0X7 7/1/2009
DP/3389 PHARMA AG (U) LIMITED REPE TABS + 120MG N.V,-INDUSTRY PARK 30, ORDINARY .0 TABLET
PSEUDOEPHE 2220 HEIST OPDENBERG FILM- BLISTER
DRINE BELGIUM COATED
TABLETS
1731 NDA/MAL/H ELYS VELVET ALUGEL ALUMINIUM 120MG/25 ELYS CHEMICAL KENYA ORAL LIQUID 1.0X100.0 7/1/1997
DP/3390 CHEMICAL PHARMA HYDROXIDEL 0MG INDUSTRIES LTD-ROAD 'B' ORDINARY ML
INDUSTRIES LIMITED / OFF ENTERPRISE ROAD, SUSPENSION BOTTLE,1.
LTD MAGNESIUM INDUSTRIAL AREA S 0X5.0 ML
TRISLICATE NAIROBI JERRYCAN
1732 NDA/MAL/H GITTOES GITTOES CEZIN CETIRIZINE 10MG AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1.0X2.0X5 7/1/2017
DP/3391 PHARMACEUT PHARMACEUTIC TABLET NO.33,SECTOR ORDINARY .0X10.0
E INDIA TABLET
CONTAIN
ER,1.0X10
.0X10.0
TABLET
BLISTER,1
00.0X10.0
1733 NDA/MAL/H GLAXOSMITH UNITED AUGMENTI AMOXICILLIN 250 MG + SMITHKLINE BEECHAM UNITED ORAL SOLID 2.0X10.0 7/1/1997
DP/3393 KLINE HEALTHCARE N 375MG + 125 MG PHARMACEUTICALS,- KINGDOM ORDINARY TABLET
PHARMACEUT DISTRIBUTORS CLAVULANIC CLARENDON ROAD, TABLETS BLISTER
LTD SUSSEX, BN148QH
1734 NDA/MAL/H AMANTA PHARMA VILLE MAGNESIU MAGNESIUM 50%W/V MARCK BIO SCIENCES LTD- INDIA PARENTERAL 1.0X50.0X 7/1/2010
DP/3394 HEALTHCARE LIMITED M SULPHATE PLOT NO 876,NH,NO 8 ORDINARY 10.0 ML
LTD SULPHATE VILL HARIYALA,KLEDA AMPOULES AMPOULE
387411
1735 NDA/MAL/H ELDA REDDYS BUPICAN BUPIVACAINE 0.5%W/V CLARIS INJECTABLES INDIA PARENTERAL 1.0X25.0X 7/1/2007
DP/3396 INTERNATION PHARMA HEAVY HYDROCHLOR LIMITED---CHACHARWADI ORDINARY 4.0 ML
AL DMCC LIMITED IDE IN VASANA 382 213 AMPOULES AMPOULE
DEXTROSE AHMEDABAD GUJARAT
1736 NDA/MAL/H AUROBINDO GITTOES TENOFOVIR TENOFOVIR 300MG AUROBINDO PHARMA INDIA ORAL SOLID 1.0X30.0 7/1/2011
DP/3397 M PHARMA PHARMACEUTIC DISOPROXIL DISOPROXIL LTD, UNIT III -SURVEY NO. ORDINARY TABLET
LIMITED ALS LIMITED FUMARATE FUMARATE 313, 314 BACHUPALLY TABLETS BOTTLE
(VILLAGE)
QUTHUBULLAPUR
HYDERABAD ANDHRA
PRADESH 500090
DP/3399 LABORATORIE PHARMA N PLOT 42 ANRICH ORDINARY 0.0
PRADESH
1738 NDA/MAL/H ACINO GOODMAN OLFEN GEL DICLOFENAC 1%W/W ACINO PHARMA AG- GERMANY TOPICAL 1.0X50.0 7/1/1997
DP/3400 PHARMA AG INTERNATIONAL SODIUM DORNACHERSTRASSE 114, EXTERNAL G
LTD CH-4147 AESCH GELS AND TUBE,1.0X
SOFARIMEX INDUSTRIA SOLS 20.0 G
QUIMIRA E TUBE
FARMACEUTICA SA-AV.
DAS INDUSTRIAS - ALTO
DO COLARIDE, 2735-213
AGUALVA CACEM
1739 NDA/MAL/H ASTRA ASTRA PHARMA ASCODYL BISACODYL 5MG ASTRA LIFE CARE (INDIA) INDIA ORAL SOLID 1.0X10.0X 7/1/2010
DP/3401 PHARMA (U) (U) LIMITED PVT.LTD-PLOT NO. 57/P, ORDINARY 10.0
LIMITED SARKHEJ-BAVLA ENTERIC- TABLET
AHMEDABAD INDIA
1740 NDA/MAL/H GLAXO UNITED CLAVULIN AMOXICILLIN 500 MG + SMITHKLINE BEECHAM UNITED PARENTERAL 1.0X10.0X 7/1/2009
DP/3404 SMITHLINE HEALTHCARE + 100 MG PHARMACEUTICALS,- KINGDOM ORDINARY 600.0 MG
LIMITED DISTRIBUTORS CLAVULANIC CLARENDON ROAD, DRY VIALS VIAL
LTD ACID WORTHING, WEST
SUSSEX, BN148QH
1741 NDA/MAL/H GLAXO SMITH UNITED PANADOL PARACETAM 120MG/5 FARMACLAIR -440 FRANCE ORAL LIQUID 1.0X100.0 7/1/2008
DP/3405 KLINE LTD HEALTHCARE BABY AND OL ML AVENUE DU GENERAL DE ORDINARY ML
DISTRIBUTORS INFANT GAULLE 14200 SUSPENSION BOTTLE
LTD 120MG/5M HEROUVILLE SAINT CLAIR S
L FRANCE
1742 NDA/MAL/H ATCO HARLEYS MICRONEM NYSTATIN 26,450MG/ ATCO LABORATORIES PVT PAKISTAN RECTAL 1.0X10.0 7/1/2005
DP/3406 LABORATORIE UGANDA A ORAL 10ML+75M LTD-B-18,S.I.T.E KARACHI, SYSTEMIC ML
S LTD LIMITED SUSPENSION, G/10ML+ PAKISTAN ENEMA BOTTLE
SODIUM 90%V/V LIQUIDS
CITRATE +
SODIUM
LAURYL
SULPHATE +
GLYCERIN
1743 NDA/MAL/H BAYER SURGIPHARM CLARITYNE LORATADINE 10MG SCHERING PLOUGH LABO BELGIUM ORAL SOLID 3.0X10.0 7/1/2000
DP/3409 PHARMA AG (U) LIMITED N.V,-INDUSTRY PARK 30, ORDINARY TABLET
2220 HEIST OPDENBERG TABLETS BLISTER
BELGIUM
1744 NDA/MAL/H ABACUS ABACUS ABNAL SODIUM 0.9%W/V ABACUS PARENTERAL UGANDA NASAL 1.0X10.0 7/1/2011
DP/3411 PARENTERAL PARENTERAL NASAL CHLORIDE DRUGS LTD.-PLOT NO. SYSTEMIC ML VIAL
DRUGS DRUGS LIMITED DROPS 114, BLOCK 191, DROPS
LIMITED GWAGAMYA, KINGA,
KAPEKE,
MUKONO
1745 NDA/MAL/H GITTOES GITTOES TETRACYCLI TETRACYCLIN 250 MG NINGBO DAHONGYING CHINA ORAL SOLID 10.0X10.0 7/1/2005
DP/3412 PHARMACEUT PHARMACEUTIC NE E PHARMACEUTICALS LTD- ORDINARY CAPSULE
ICALS LIMITED ALS LIMITED HYDROCHLOR NO. 396 MIN CAPSULES BLISTER,1.
IDE 0X1000.0
CAPSULE
CONTAIN
ER
1746 NDA/MAL/H JOHNSON PHILLIPS COMBANTR PYRANTEL 125MG JOHNSON&JOHNSON PTY SOUTH ORAL SOLID 1.0X6.0 7/1/1997
DP/3413 &JOHNSON PHARMACEUTIC IN PAMOATE LTD.-EDMS BPK241 MAIN AFRICA ORDINARY TABLET
(PTY) LTD ALS (UGANDA) ROAD /HOOFWEG TABLETS BLISTER,1.
LIMITED 241,RETREAT 7945,SOUTH 0X100.0
AFRICA TABLET
CONTAIN
ER
1747 NDA/MAL/H NOVARTIS SURGIPHARM EXFORGE AMLODIPINE 10 MG + NOVARTIS PHARMA STEIN SWITZERLAN ORAL SOLID 1.0X2.0X1 7/1/2007
DP/3414 PHARMA AG (U) LIMITED 10MG/160 + VALSARTAN 160 MG AG-H-4332 STEIN D ORDINARY 4.0
MG SCHAFFAUSERTRASSE FILM- TABLET
NOVARTIS FARMACEUTICA COATED BLISTER
SA-RONDA DE SANTA TABLETS
MARIA,158, E-08210
BARBERA DEL VALLES
BARCELONA SPAIN
1748 NDA/MAL/H GLENMARK STAR CANDID V-1 CLOTRIMAZO 500MG GLENMARK INDIA VAGINAL 1.0X1.0 7/1/2004
DP/3415 PHARMACEUT PHARMACEUTIC LE PHARMACEUTICALS LTD- TABLETS PESSARY
ICAL LTD ALS LTD PLOT NO E -37, 39 ,D STRIP
1749 NDA/MAL/H USAID KAMPALA INJECTAPLA MEDROXYPR 150MG KAMPALA INDIA PARENTERAL 1.0X1.0 7/1/2001
DP/3416 PHARMACEUTIC N OGESTERONE PHARMACEUTICAL ORDINARY ML
AL INDUSTRIES INDUSTRIES LTD-P.O.BOX AMPOULES AMPOULE
1996 LIMITED 7551 KAMPALA
1750 NDA/MAL/H MEDIPHARM MEDIPHARM PIRITEX COUGH 0.42ML/5 MEDIPHARM INDUSTRIES UGANDA ORAL LIQUID 1.0X60.0 7/1/2006
DP/3419 (EA) LTD INDUSTRIES BABY LINCTUS ML (E.A) LTD-PLOT 65, ORDINARY ML
(E.A) LTD COUGH WITH DILUTE KAKAJJO ROAD, SYRUPS BOTTLE
LINCTUS ACETIC ACID BWEYOGERERE
1751 NDA/MAL/H ROYAL ABACUS COMBINOL ATCO LABORATORIES PVT PAKISTAN ORAL LIQUID 1.0X120.0 7/1/1999
DP/3421 GROUP PHARMA E LTD-B-18,S.I.T.E KARACHI, ORDINARY ML
(AFRICA) PAKISTAN SYRUPS BOTTLE
LIMITED
1752 NDA/MAL/H REGAL REGAL PHARMA RUBEM METHYL 1%W/W+0. REGAL KENYA TOPICAL 1.0X25.0 7/1/1997
DP/3426 PHARMACEUI (U) LTD CREAM NICOTINATE 1%W/W+5 PHARMACEUTICALS LTD- EXTERNAL G TUBE
CALS LTD + CAPSICUM %W/W BABA DOGO ROAD, CREAMS
OLEORESIN+ RAURAKA,NAIROBI,KENYA
METHYLSALIC
YLATE
1753 NDA/MAL/H MEDI MEDIPHARM ORALYTE MULTI MULTI MEDI PHARMA UGANDA ORAL SOLID 1.0X2.0X2 7/1/2013
DP/3428 PHARMA INDUSTRIES CO-PACK INGREDIENT INGREDIEN INDUSTRIES E.A LTD-PLOT ORDINARY 0.5 G
IDUSTRIES E.A (E.A) LTD T 65 KAKAJJO ROAD OTHER SACHET +
LTD BWEYOGERERE SPECIAL 1*60.0 ML
FORMS BOTTLE
1754 NDA/MAL/H XEPA-SOUL DELMAW EZEDE LORATADINE 10MG XEPA-SOUL PATTINSON MALAYSIA ORAL SOLID 1.0X10.0 7/1/2006
DP/3429 PATTINSON ENTERPRISES (MALAYSIA) SDN BHD-1-5 ORDINARY TABLET
LIMITED CHENG INDUSTRIAL TABLETS BLISTER
ESTATE, 75250
MALEKA, MALAYSIA
1755 NDA/MAL/H NOVARTIS SURGIPHARM CO-DIOVAN VALSARTAN + 80 MG NOVARTIS PHARMA SPA,- SWITZERLAN ORAL SOLID 1.0X2.0X1 7/1/2016
DP/3433 PHARMA AG (U) LIMITED 80/12.5 HYDROCHLOR +12.5 MG TORRE ANNUNZIATA D ORDINARY 4.0
OTHIAZIDE ITALY NOVARTIS PHARMA TABLETS TABLET
STEIN AG.-SCHAFF BLISTER
HAUSER STRASSE 4332,
STEIN - SWITZERLAND
1756 NDA/MAL/H BETA BETA SEPTRIN CO- 480MG GLAXO WELLCOME EGYPT EGYPT ORAL SOLID 1.0X1000. 7/1/1997
DP/3434 HEALTHCARE HEALTHCARE TRIMOXAZOL CO. S.A.E-CAIRO ORDINARY 0 TABLET
UGANDA UGANDA E TABLETS CONTAIN
LIMITED LIMITED ER,1.0X10
.0 TABLET
CARTON,1
.0X50.0
TABLET
CARTON
1757 NDA/MAL/H REMEDICA GOODMAN REMYCIN DOXYCYCLINE 100MG REMEDICA LIMITED - CYPRUS ORAL SOLID 1.0X10.0X 7/1/1997
DP/3437 LTD INTERNATIONAL 100 HYDROCHLOR AHARNON STREET, ORDINARY 10.0
LTD CAPSULES IDE LIMASSOL INDUSTRIAL CAPSULES CAPSULE
CYPRUS 3056, CYPRUS
1758 NDA/MAL/H RENE RENE RENECHLO CHLORAMPH 250MG RENE INDUSTRIES LTD- UGANDA ORAL SOLID 1.0X1000. 7/1/2001
DP/3439 INDUSTRIES INDUSTRIES R CAPSULE ENICOL PLOT 680, KAMULI ROAD, ORDINARY 0
LTD LIMITED KIREKA, P.O BOX 6034, CAPSULES CAPSULE
KAMPALA CONTAIN
ER,10.0X1
0.0
CAPSULE
BLISTER
1759 NDA/MAL/H ELI-LILLY LABOREX HUMALOG INSULIN 100IU LILLY FRANCE SA-FRANCE FRANCE PARENTERAL 1.0X10.0 7/1/2000
DP/3440 EXPORT SA UGANDA LISPRO ORDINARY S ML VIAL
LIMITED C VIALS
1760 NDA/MAL/H CIPLA LTD QUALITY LEVOFLOXA LEVOFLOXACI 500MG CIPLA LTD.- -PLOT NO INDIA ORAL SOLID 1.0X10.0X 7/1/2009
DP/3441 CHEMICALS LTD - CIN N L/139 TO L/146, VERNA ORDINARY 10.0
HUMAN INDUSTRIAL ESTATE, TABLETS TABLET
VERNA, SOUTH GOA BLISTER
1761 NDA/MAL/H KAMPALA KAMPALA BETASOL BETAMETHAS 0.1%W/W KAMPALA UGANDA TOPICAL 1.0X30.0 7/1/1997
DP/3443 PHARMACEUT PHARMACEUTIC OINTMENT ONE PHARMECEUTICALS EXTERNAL G
ICAL AL INDUSTRIES VALERATE INDUSTRIES LTD-PLOT OINTMENTS TUBE,1.0X
INDUSTRIES 1996 LIMITED M444B STRETCHER RD, 15.0 G
1996 LIMITED NTINDA KLA UGANDA TUBE
1762 NDA/MAL/H UNICHEM EUROPA CORVADIL AMLODIPINE 10MG UNICHEM LABORATORIES INDIA ORAL SOLID 1.0X3.0X1 7/1/2010
DP/3444 LABORATORIE HEALTHCARE 10 BESILATE LIMITED-UNICHEM ORDINARY 0.0
S LTD (U) LTD LABORATORIES LIMITED. TABLETS TABLET
UNIT II, VILLAGE STRIP
173 205, HIMACHAL
PRADESH, INDIA
1763 NDA/MAL/H SANOFI- SURGIPHARM CORDARON AMIODARON 50MG/ML SANOFI WINTHROP FRANCE PARENTERAL 1.0X3.0 7/1/1998
DP/3446 AVENTIS (U) LIMITED E E INDUSTRIE-LAGRAGE ORDINARY ML
HYDROCHLOR 33565 CARBON BLANC AMPOULES AMPOULE
IDE CEDEX FRANCE
1764 NDA/MAL/H VENUS HARLEYS IMMUNOX CEFTRIAXONE 1000MG VENUS REMEDIES LIMITED INDIA PARENTERAL 1.0X1000. 7/1/2008
DP/3449 REMEDIES UGANDA SODIUM ,.-HILL TOP,INDUSTRIAL ORDINARY 0 MG
LTD LIMITED ESTATE,JHARMAJRI, DRY VIALS VIAL,1.0X
EPIP,PHASE 1,(EXTN.) 10.0X1.0X
,BHATOLI KALAN,BADDI - 10.0 ML
H.P.INDIA VIAL
1765 NDA/MAL/H DELORBIS ABACUS TRAMADEX TRAMADOL 50MG DELORBIS CYPRUS ORAL SOLID 1.0X3.0X1 7/1/2009
DP/3450 PHARMACEUT PHARMA 50 PHARMACEUTICALS LTD- ORDINARY 0.0
ICALS LTD (AFRICA) 17, ATHINON STREET, CAPSULES CAPSULE
LIMITED ERGATES INDUSTRIAL BLISTER
AREA, 2643 ERGATES P.O.
BOX 28629, 2081
LEFKOSIA
1766 NDA/MAL/H GITTOES GITTOES AGOPHENO CHLORAMPH 250MG AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 10.0X10.0 7/1/1998
DP/3451 PHARMACEUT PHARMACEUTIC L CAPSULES ENICOL NO.33,SECTOR ORDINARY CAPSULE
ICALS LIMITED ALS LIMITED (THANE0 II,VASAI,TALUKA INDL CO- CAPSULES BLISTER,1.
OP ESTATE LTD,GAURAI 0X100.0
PADA,VASAI(E)DIST.THAN CAPSULE
E INDIA CONTAIN
ER,1.0X10
00.0
CAPSULE
CONTAIN
ER,1.0X50
0.0
1767 NDA/MAL/H VENUS AARON PAXOL PACLITAXEL 30MG/5ML VENUS REMEDIES LTD- INDIA PARENTERAL 1.0X5.0 7/1/2008
DP/3452 REMEDIES PHARMACEUTIC USP VNIT-11 HILL TOP ORDINARY ML VIAL
LTD ALS LTD INDUSTRAL ESTATE OTHER VIALS
JHARRUJIRI EPIP INDIA
1768 NDA/MAL/H MJ TATA UGANDA AMINOPHY AMINOPHYLLI 25MG/ML M.J BIOPHARM PVT LTD- INDIA PARENTERAL 1.0X10.0X 7/1/2014
DP/3453 BIOPHARM LIMITED LLINE NE TALOJA DISTRICT RAIGAD ORDINARY 10.0X10.0
PVT LTD 410208 NAVI MUMBAI AMPOULES ML
AMPOULE
DP/3455 LABORATORIE LTD E+ + 60MG LTD--F-4,F-12 MALEGAON ORDINARY TABLET
S LIMITED ZIDOVUDIN ZIDOVUDINE MIDC SINNAR NASHIK FILM- BOTTLE
E 422113 MAHARASHTRA COATED
STATE TABLETS
1770 NDA/MAL/H JOHNSON&JO PHILLIPS ANUSOL BISMUTH 22.5 MG + PERFORMANCE HEALTH SOUTH TOPICAL 1.0X25.0 7/1/1997
DP/3457 HNSON PTY PHARMACEUTIC OINTMENT SUBGALLATE 8.75 MG + LTD-241 NAIN ROAD AFRICA EXTERNAL G TUBE
LTD ALS (UGANDA) + BISMUTH 107.5 MG RETREAT SOUTH AFRICA OINTMENTS
LIMITED OXIDE + ZINC 7945
OXIDE
1771 NDA/MAL/H REGAL REGAL PHARMA UNIXIL AMOXYCILLIN 250MG REGAL KENYA ORAL SOLID 1.0X10.0X 7/1/1997
DP/3458 PHARMACEUI (U) LTD 250MG TRIHYDRATE PHARMACEUTICALS LTD- ORDINARY 10.0
CALS LTD BABA DOGO ROAD, CAPSULES CAPSULE
0X1000.0
CAPSULE
CONTAIN
ER
1772 NDA/MAL/H AMOUN WIDE ENEMAX HYPERTONIC 6GM AND AMOUN EGYPT RECTAL 1.0X120.0 7/1/1997
DP/3459 PHARMACEUT SPECTRUM SOLUTION OF 16GM/100 PHARMACEUTICALS SYSTEMIC ML
ICALS ENTERPRISES SODIUM ML COMPANY-1ST ENEMA BOTTLE
COMPANY (U) LIMITED PHOSPHATES INDUSTRIAL ZONE EL LIQUIDS
OBOUR CITY CAIRO
EGYPT
1773 NDA/MAL/H GLAXOSMITH UNITED MALANIL ATOVAQUON 250MG + GLAXO WELLCOME S.A SPAIN ORAL SOLID 1.0X1.0X1 7/1/2007
DP/3460 KLINE HEALTHCARE ADULT E+ 100MG ARANDA-ARANDA AVDA ORDINARY 2.0
PHARMACEUT DISTRIBUTORS TABLETS PROGUANIL EXTREMADURA 3, 09400 FILM- TABLET
ICAL KENYA LTD HCL ARANDA DE DUERO COATED BLISTER
LTD BURGOS TABLETS
1774 NDA/MAL/H MYLAN KIMSY MEDS ZIDOVUDIN ZIDOVUDINE 300MG MYLAN LABORATORIES INDIA ORAL SOLID 1.0X60.0 7/1/2008
DP/3461 LABORATORIE LTD E LIMITED.-PLOT NO. H-12 & ORDINARY TABLET
S LIMITED H-13 FILM- BOTTLE
MIDC, WALUJ INDUSTRIAL COATED
AREA, TABLETS
MAHARASHTRA STATE,
INDIA.
1775 NDA/MAL/H VENUS AARON PLATOL CISPLATIN 500MG/10 VENUS REMEDIES LTD -- INDIA PARENTERAL 1.0X100.0 7/1/2014
DP/3462 REMIDIES LTD PHARMACEUTIC 0ML UNIT II HILL TOP ORDINARY ML
ALS LTD INDUSTRIAL ESTATE INFUSION BOTTLE
JHARMAJRI EPIP PHASE I VIALS/BOTTL
BHATOLI KALAN BADDI ES
(H.P)
1776 NDA/MAL/H JOHNSON PHILLIPS TARTAR ZINC 18MG/ JOHNSON&JOHNSON PTY SOUTH ORAL LIQUID 1.0X500.0 7/1/2007
DP/3464 &JOHNSON PHARMACEUTIC CONTROL CHLORIDE + 20ML + LTD..-241 MAIN ROAD AFRICA ORDINARY ML
(PTY) LTD ALS (UGANDA) LISTERINE DENATURED 0.9ML/20 RETREAT 794 OTHER BOTTLE,1.
LIMITED ANTISEPTIC ALCOHOL ML + LIQUIDS 0X250.0
MENTHOL 12.7MG/20 ML
95% + ML BOTTLE
THYMOL
1777 NDA/MAL/H MONDI- SURGIPHARM FECONTIN- FERROUS 100MG+61 MODI MUNDIPHARMA INDIA ORAL SOLID 1.0X10.0X 7/1/2008
DP/3465 MUNDI (U) LIMITED Z GLYCINE .8MG+0.5 (PVT) LTD-MEERUT - ORDINARY 10.0
PHARMA PVT SULPHATE+ZI MG MUZAFFARNAGAR ROAD, COATED TABLET
LIMITED NC MODIPURAM, UTTAR TABLETS BLISTER
SULPHATE+F PRADESH ESTATE
OLIC ACID
1778 NDA/MAL/H DAWA SUPER MEDIC DAWASEC SECNIDAZOLE 1G DAWA LTD -PLOT KENYA ORAL SOLID 1.0X2.0 7/1/2015
DP/3466 LIMITED LTD NO.7879/8 BABA ROAD ORDINARY TABLET
RUARAKA NAIROBI TABLETS BLISTER
1779 NDA/MAL/H VENUS HARLEYS RONEM MEROPENEM 1000MG VENUS REMEDIES LTD -- INDIA PARENTERAL 1.0X1000. 7/1/2008
DP/3467 REMEDIES UGANDA TRIHYDRATE UNIT II HILL TOP ORDINARY 0 MG VIAL
LTD LIMITED INDUSTRIAL ESTATE DRY VIALS
BHATOLI KALAN BADDI
(H.P)
1780 NDA/MAL/H VENUS AARON PAXOL PACLITAXEL 100MG/16. VENUS REMEDIES LTD -- INDIA PARENTERAL 1.0X20.0 7/1/2008
DP/3471 REMEDIES PHARMACEUTIC 7ML UNIT II HILL TOP ORDINARY ML VIAL
LTD ALS LTD INDUSTRIAL ESTATE VIALS
BHATOLI KALAN BADDI
(H.P)
1781 NDA/MAL/H ABACUS ABACUS TRIXONE CEFTRIAXONE 1G REYOUNG CHINA PARENTERAL 1.0X1.0X1 7/1/2011
DP/3473 PHARMA (A) PHARMA PHARMACEUTICAL CO. ORDINARY .0 G
LTD. (AFRICA) LTD-NO. 6 ERLANGSHAN DRY VIALS VIAL,1.0X
LIMITED ROAD, YIYUAN, 10.0X1.0
SHANDONG 256100 G VIAL
SHANDONG P.R & INJECT
CARE PARENTERALS PVT
LTD-PLOT 130, SILVASSA
ROAD,G.I.D.C,VAPI-
396195,GUJARAT,INDIA
1782 NDA/MAL/H RENE RENE AMCLOREN AMPICILLIN + 125MG+12 RENE INDUSTRIES LTD- UGANDA ORAL LIQUID 1.0X100.0 7/1/2008
DP/3474 INDUSTRIES INDUSTRIES DRY SYRUP CLOXACILLIN 5MG/5ML 680,KAMULI,KIREKA ORDINARY ML
LIMITED LIMITED KAMPALA,UGANDA DRY BOTTLE
SUSPENSION
S/SYRUPS/D
ROPS
1783 NDA/MAL/H VENUS HARLEYS RONEM MEROPENEM 500MG VENUS REMEDIES LTD, INDIA PARENTERAL 1.0X500.0 7/1/2010
DP/3475 REMIDIES LTD UGANDA UNIT II,-HILL TOP ORDINARY MG VIAL
LIMITED INDUSTRIAL ESTATE, DRY VIALS
KALAN, BADDI -HP
1784 NDA/MAL/H RENE RENE DICLOREN DICLOFENAC 50MG RENE INDUSTRIES LTD- UGANDA ORAL SOLID 1.0X10.0X 7/1/2009
DP/3478 INDUSTRIES INDUSTRIES SODIUM BP 680,KAMULI,KIREKA ORDINARY 10.0
LIMITED LIMITED KAMPALA,UGANDA ENTERIC- TABLET
COATED BLISTER
TABLETS
1785 NDA/MAL/H CIPLA LTD QUALITY HYOSPAN HYOSCINE 10MG CIPLA LTD -MIDC INDIA ORAL SOLID 1.0X1000. 7/1/2009
DP/3480 CHEMICALS LTD - BUTYL PATALGANGA MS 410 220 ORDINARY 0 TABLET
HUMAN BROMIDE INDIA MFG LIC: 845 TABLETS CONTAIN
ER
1786 NDA/MAL/H GITTOES GITTOES AGOCLOX- CLOXACILLIN 250MG MILAN LABORATORIES - INDIA ORAL SOLID 1.0X10.0X 7/1/2011
DP/3482 PHARMACEUT PHARMACEUTIC 250 PLOT NOS 63, 67 & 87, ORDINARY 10.0
ICALS LIMITED ALS LIMITED JAWAHAR CO-OP. CAPSULES CAPSULE
INDUSTRIAL BLISTER
ESTATE LTD.,
MUMBAI).
1787 NDA/MAL/H JOHNSON&JO PHILLIPS SINUTAB 3- IBUPROFEN + 200MG + JOHNSON&JOHNSON PTY SOUTH ORAL SOLID 1.0X2.0X1 7/1/2007
DP/3483 HNSON PTY PHARMACEUTIC WAY PSEUDOEPHE 30MG LTD.-EDMS BPK241 MAIN AFRICA ORDINARY 0.0
LTD. 241 ALS (UGANDA) DRINE HCL ROAD /HOOFWEG FILM- TABLET
LIMITED 241,RETREAT 7945,SOUTH COATED BLISTER
AFRICA TABLETS
1788 NDA/MAL/H CIRON DRUGS RENE ERGOMETR ERGOMETRIN 0.5MG/ML CIRON DRUGS AND INDIA PARENTERAL 1.0X100.0 7/1/2007
DP/3485 & PHARMACY LTD INE E MALEATE PHARMACEUTICALS ORDINARY X1.0 ML
PHARMACEUT PRIVATE LTD-N-118 MIDC AMPOULES AMPOULE
ICALS PVT LTD TARAPUM BOISAR DIST
THANE 401506
MAHARASHTRA, INDIA
1789 NDA/MAL/H PFIZER LABOREX NEO METHYLPRED 2.5MG+2.5 PATHEON YM INC. CANADA TOPICAL 1.0X25.0 7/1/1997
DP/3489 LABORATORIE UGANDA MEDROL NISOLONE MG TORONTO- TORONTO, EXTERNAL ML
S PTY LTD LIMITED ACETATE+ CANADA LOTIONS BOTTLE
NEOMYCIN
SULFATE
1790 NDA/MAL/H MEDICAL KARURI LAXOLAC LACTULOSE 67G/100M MEDICAL UNION EGYPT ORAL LIQUID 1.0X120.0 7/1/2003
DP/3490 UNION PHARMACEUTIC SYRUP L PHARMACEUTICALS LTD- ORDINARY ML
PHARMACEUT ALS LTD. ABU SULTAN, ISMAILLIA, SYRUPS BOTTLE
ICALS EGYPT
1791 NDA/MAL/H ACINO GOODMAN OLFEN-50 DICLOFENAC 50MG ACINO PHARMA AG - SWITZERLAN ORAL SOLID 1.0X2.0X1 7/1/1997
DP/3492 PHARMA AG INTERNATIONAL SODIUM DORNACHERSTRASSE, 114, D ORDINARY 0.0
LTD 4147, AESCH, FILM- TABLET
SWITZERLAND COATED BLISTER
TABLETS
1792 NDA/MAL/H ASTRA LIFE ASTRA PHARMA ASVIR ACICLOVIR 200MG ASTRA LIFE CARE (INDIA) INDIA ORAL SOLID 1.0X10.0X 7/1/2007
DP/3493 CARE (INDIA) (U) LIMITED PVT LTD-57/P,RAJODA ORDINARY 10.0
PVT LTD 382220, BAVLA TABLETS TABLET
AHMEDABAD INDIA BLISTER
1793 NDA/MAL/H FERRER LABOREX GAMALATE MAGNESIUM 2G + 2G + FERRER INTERNATIONAL, SPAIN ORAL LIQUID 1.0X80.0 7/1/2015
DP/3494 INTERNATION UGANDA B6 GLUTAMATE 1G +1G S.A.-C/JOAN BUSCALLA, 1- ORDINARY ML
AL, S.A. LIMITED SOLUTION HYDROBROM 9.08173 SANT CUGAT DEL LIQUIDS BOTTLE
IDE + VALLES, BARCELONA
AMINOBUTYR
IC ACID +
AMINO
HYDROXYBUT
YRIC ACID +
VITAMIN B6
1794 NDA/MAL/H BELL SONS & ECHO MENTHODE MULTIINGRE N/A BELL SONS & CO UNITED ORAL LIQUID 1.0X100.0 7/1/2001
DP/3495 CO.(DRUGGIS PHARMACY (U) X COUGH DIENT (DRUGGISTS) LTD- KINGDOM ORDINARY ML
TS) LTD LIMITED MIXTURE SLAIDBURN CRES SYRUPS BOTTLE,1.
CHESHIRE HOUSE/GORSEY 0X200.0
LA ML
BOTTLE
1795 NDA/MAL/H MEGA ABACUS LIVOLIN MULTI- MULTI- MEGA LIFE SCIENCES THAILAND ORAL SOLID 1.0X3.0X1 7/1/2009
DP/3497 LIFESCIENCES PHARMA FORTE INGREDIENT INGREDIEN LIMITED-: PLANT I : 384 ORDINARY 0.0
(AUSTRALIA) (AFRICA) T SOI 6, PATTANA 3 ROAD, CAPSULES CAPSULE
PTY LTD LIMITED BANGPOO INDUSTRIAL BLISTER
ESTATE, SAMUTPRAKAN
10280, THAILAND
1796 NDA/MAL/H DAR AL DAWA GAMA GIZLAN 300 IRBESARTAN 300MG DAR AI DAWA-NA UR JORDAN ORAL SOLID 1.0X3.0X1 7/1/2014
INVESTMENT BLISTER
CO LTD
1797 NDA/MAL/H EGYPTIAN WIDE HYDROCOR HYDROCORTI 100MG EGYPTIAN EGYPT PARENTERAL 1.0X100.0 7/1/2010
DP/3502 INTERNATION SPECTRUM TISONE SONE INTERNATIONAL ORDINARY MG VIAL +
AL ENTERPRISES SODIUM SODIUM PHARMACEUTICAL DRY VIALS 1*2ML
PHARMACEUT (U) LIMITED SUCCINATE SUCCINATE INDUSTRIES COMPANY- AMPOULE
ICAL 10TH OF RAMADAN CITY OF WFI
COMPANY
1798 NDA/MAL/H MENARINI PHILLIPS BIFRIL ZOFENOPRIL 30MG A.MENARINI ITALY ORAL SOLID 1.0X2.0X1 7/1/2015
DP/3504 INTERNATION PHARMACEUTIC MANUFACTURING ORDINARY 4.0
AL ALS (UGANDA) LOGISTICS AND SERVICES FILM- TABLET
OPERATIONS LIMITED S.R.I-VIA CAMPO DI PILE COATED BLISTER,1.
LUXEMBOUR 67100 L'AQUILA TABLETS 0X1.0X7.0
G S.A. TABLET
BLISTER
1799 NDA/MAL/H ASTRA LIFE ASTRA PHARMA ASFLIC FOLIC ACID 5MG ASTRA LIFE CARE (INDIA) INDIA ORAL SOLID 1.0X1000. 7/1/2007
DP/3505 CARE (INDIA) (U) LIMITED PVT LTD-57/P,RAJODA ORDINARY 0 TABLET
PVT LTD 382220, BAVLA TABLETS CONTAIN
AHMEDABAD INDIA ER,1.0X10
.0X10.0
TABLET
BLISTER
1800 NDA/MAL/H ABBVIE (PTY) UNITED ULTANE SEVOFLURAN 100%W/W AESICA QUEESNBOROUGH UNITED NASAL 1.0X250.0 7/1/2011
DP/3506 LTD HEALTHCARE E LTD- NORTH RD. KINGDOM SYSTEMIC ML
DISTRIBUTORS QUEENSBOROUGH KENT UNIT DOSE BOTTLE
LTD LIQUIDS
1801 NDA/MAL/H MEDOPHARM PLANET MEDOMOX AMOXICILLIN 250MG MEDOPHARM PVT LTD.- INDIA ORAL SOLID 1.0X10.0X 7/1/2015
DP/3507 PRIVATE PHARMACEUTIC 250 NO. 50 KAYARAMBEDU ORDINARY 10.0
LIMITED ALS UGANDA VILLAGE GUDUVANCHERY CAPSULES CAPSULE
LTD 603 203 CHENGALPET BLISTER,1.
DISTRICT TAMIL NADU 0X1000.0
CAPSULE
CONTAIN
ER
1802 NDA/MAL/H AJANTA ABACUS ARTEFAN ARTEMETHER 40 MG + AJANTA PHARMA LTD .-B- INDIA ORAL SOLID 1.0X2.0X6 7/1/2007
DP/3515 PHARMA LTD PHARMA 40/240 + 40 MG 4//5/6, MIDC ORDINARY .0 TABLET
(AFRICA) LUMEFANTRI INDUSTRIALAREA, TABLETS BLISTER
LIMITED NE PAITHAN-431 128,
AURANGBAD
1803 NDA/MAL/H COSMOS LTD ASTRA PHARMA BENZHEXOL TRIHEXYPHEN 5MG COSMOS LIMITED-- KENYA ORAL SOLID 1.0X1000. 7/1/1998
DP/3516 (U) LIMITED TABLETS BP IDYL RANGWA ROAD, OFF ORDINARY 0 TABLET
5MG HYDROCHLOR LUNGA LUNGA ROAD,P.O TABLETS CONTAIN
IDE BOX 414 33, NAIORBI ER,1.0X10
INDUSTRIAL AREA 0.0
TABLET
BLISTER
1804 NDA/MAL/H ABACUS ABACUS TOTO ZINC ZINC 20MG MEDICAMEN BIOTECH LTD- INDIA ORAL SOLID 1.0X10.0X 7/1/2013
DP/3517 PHARMA (A) PHARMA SULPHATE SP-1192, A &B, PHASE –IV, ORDINARY 10.0
LTD. (AFRICA) INDUSTRIAL AREA SOLUBLE TABLET
LIMITED BHIWADI -301019 DIST. TABLETS BLISTER
ALWAR (RAJASTHAN)
1805 NDA/MAL/H STEDMAN VEERAM DREZ POVIDONE 1%W/W + STEDMAN INDIA TOPICAL 1.0X100.0 7/1/2010
DP/3520 PHARMACEUT HEALTHCARE POWDER IODINE + 5%W/W PHARMACEUTICALS PVT EXTERNAL G
ICALS PVT. (U) LIMITED METRONIDAZ LIMITED-NO. C-4, SIDCO POWDERS BOTTLE,1.
LTD OLE PHARMACEUTICAL 0X10.0 G
COMPLEX, ALATHUR, BOTTLE
THIRUPORUR,
1806 NDA/MAL/H GITTOES GITTOES CLOXACILLI CLOXACILLIN 500MG CSPC ZHONGNUO CHINA PARENTERAL 1.0X10.0X 7/1/2011
DP/3522 PHARMACEUT PHARMACEUTIC N SODIUM SODIUM PHARMACEUTICAL ORDINARY 500.0 MG
ICALS LIMITED ALS LIMITED FOR (SCIJIAZHUANG) CO. LTD VIALS VIAL
INJECTION WORKSHOP -NO. 88
YANGZI ROAD,
SHIJIAZHUANG CITY,
1807 NDA/MAL/H GITTOES GITTOES AGOCLLIN AMPICILLIN 250MG MILAN LABORATORIES INDIA ORAL SOLID 1.0X10.0X 7/1/1998
DP/3525 PHARMACEUT PHARMACEUTIC TRIHYDRATE (INDIA ) PVT LTD-PLOT ORDINARY 10.0
ICALS LIMITED ALS LIMITED NO.63-67 & 87,JAWAHAR CAPSULES CAPSULE
CO.OP.INDUSTRIAL BLISTER,1.
ESTATE LTD 0X1000.0
KAMOTHE,PANVEL DIST. CAPSULE
THANE,MAHARASTRA- CONTAIN
410209,INDIA ER,1.0X10
0.0X10.0
CAPSULE
BLISTER
1808 NDA/MAL/H AJANTA ABACUS LEVOTOP- LEVOFLOXACI 500MG AJANTA PHARMA LIMITED- INDIA ORAL SOLID 1.0X1.0X1 7/1/2009
DP/3527 PHARMA LTD PHARMA 500 N AJANTA PHARMA LIMITED ORDINARY 0.0
(AFRICA) B-4-5-6, MIDC AREA FILM- TABLET
LIMITED PAITHAN, AURANGABAD, COATED BLISTER
431148 TABLETS
DIST:AURANGABAD
MAHARASHTRA, INDIA.
1809 NDA/MAL/H LEBEN ANDYCO ADIFLAM- DICLOFENAC 50MG LEBEN LABORATORIES PVT INDIA ORAL SOLID 1.0X10.0X 7/1/2007
DP/3535 LABORATORIE PHARMACY 50 SODIUM LTD --L4 PHASEIII M.I.D.C ORDINARY 10.0
S PVT LTD (UGANDA) LTD GASTRO- AKOLA 444 104 ENTERIC- TABLET
RESISTANT MAHARASHTRA COATED BLISTER
TABLETS BP TABLETS
1810 NDA/MAL/H SANOFI LABOREX TETRAXIM DIPHTHERIA/ 301IU/ SANOFI PASTEUR CAMPUS FRANCE PARENTERAL 1.0X0.5 7/1/2011
DP/3536 PASTEUR UGANDA TETANUS/ 401IU/ MERIEUX--1541 AVENUE ORDINARY ML PRE-
LIMITED PERTUSSIS 25MCG/ MARCEL MERIEUX, 69280 PRE-FILLED FILLED
(ACELLULAR, POLIOMYE MARCY, LETOILE SANOFI SYRINGES SYRINGE
COMPONENT LITIS - PASTEUR S.A-2,AVENUE
) 40DU PONT PASTEUR 69007
POLIOMYELIT (TYPE 1)/ LYON-FRANCE(BUSINESS
IS 8DU TYPE ADDRESS)
(INACTIVATE 2/ 32DU
D) VACCINE TYPE 3
(ADSORBED)
1811 NDA/MAL/H EAGLEVET MEDVIN CLOPACT- CLOPIDOGREL 75 MG IPCA INDIA ORAL SOLID 1.0X3.0X1 7/1/2008
DP/3540 UGANDA PHARMA 75 LABORATORIESLIMITED- ORDINARY 0.0
LIMITED LIMITED IPCA LABORATORIES LTD TABLETS TABLET
P.O SEJANTA DISTRICT BLISTER
RATLAM 457002 INDIA
1812 NDA/MAL/H VENUS HARLEYS CARBOL CARBOPLATI 450MG/45 VENUS REMEDIES LTD, INDIA PARENTERAL 1.0X45.0 7/1/2008
DP/3541 REMEDIES UGANDA N ML UNIT II,-HILL TOP ORDINARY VIAL
LTD LIMITED INDUSTRIAL ESTATE, VIALS CARTON
KALAN, BADDI -HP
1813 NDA/MAL/H BETA BETA MARA ASPIRIN + 400MG + BETA HEALTHCARE KENYA ORAL SOLID 1.0X50.0X 7/1/2005
DP/3542 HEALTHCARE HEALTHCARE MOJA PARACETAM 200MG + INTERNATIONAL LTD - - ORDINARY 2.0
INTERNATION UGANDA OL + 50MG PLOT TABLETS TABLET
AL LTD LIMITED CAFFEINE NO.209/6554,MOGADISHU STRIP,1.0X
ROAD,OFF LUNGA LUNGA 110.0X2.0
INDUSTRIAL AREA, TABLET
P.O.BOX 42569-001000 STRIP
NAIROBI,KENYA
1814 NDA/MAL/H GLENMARK STAR CANDID CLOTRIMAZO 1%W/W GLENMARK INDIA ORAL 1.0X15.0 7/1/2000
DP/3545 PHARMACEUT PHARMACEUTIC MOUTH LE PHARMACEUTICALS LTD- TOPICAL ML
ICAL LTD ALS LTD PAINT PLOT NO E -37, 39 ,D LIQUIDS BOTTLE
1815 NDA/MAL/H RENE RENE RENETRIM SULPHAMETH 800MG + RENE INDUSTRIES LIMITED- UGANDA ORAL SOLID 1.0X10.0X 7/1/2013
DP/3546 INDUSTRIES INDUSTRIES D.S OXAZOLE + 160MG PLOT 680 KAMULI KIREKA ORDINARY 10.0
LTD LIMITED TRIMETHOPRI TABLETS TABLET
M BLISTER,1.
0X500.0
TABLET
CONTAIN
ER,1.0X10
00.0
TABLET
CONTAIN
ER
1816 NDA/MAL/H UNICHEM EUROPA CORBIS-10 BISOPROLOL 10 MG UNICHEM LABORATORIES INDIA ORAL SOLID 1.0X3.0X1 7/1/2008
S LTD (U) LTD BHATAULI KALAN BADDI FILM- TABLET
DIST SOLAN HIMACHAL COATED STRIP
1817 NDA/MAL/H CIPLA QUALITY BECORT BECLOMETAS 200MCG/D CIPLA LTD.- -PLOT NO INDIA LUNG 1.0X200.0 7/1/2009
DP/3548 LIMITED CHEMICALS LTD - 200 ONE OSE L/139 TO L/146, VERNA ADMINISTRA METERED
HUMAN INDUSTRIAL ESTATE, TION DOSE
VERNA, SOUTH GOA METERED- CANNISTE
DISTRICT, 403722 GOA DOSE R
INHALER
1818 NDA/MAL/H REGAL REGAL PHARMA TRIMEX CHLORPHENI 1.0MG+15. REGAL KENYA ORAL LIQUID 1.0X60.0 7/1/2007
DP/3549 PHARMACEUT (U) LTD PAEDIATRIC RAMINE 0MG+50.0 PHARMACEUTICALS ORDINARY ML
ICALS LTD COUGH MALEATE+PS MG+0.5M LIMITED -PLOT 7879/18 SYRUPS BOTTLE
EXPECTORA EUDO G / 5ML OF BABA DOGO ROAD,
NT EPHEDRINE RUARAKA, NAIROBI
HCL+GUAIPH
ENISIN+MENT
HOL
1819 NDA/MAL/H VENUS AARON DOXOL DOCETAXEL 20MG/0.5 VENUS REMEDIES LTD, INDIA PARENTERAL 1.0X7.5 7/1/2008
DP/3550 REMEDIES PHARMACEUTIC ML UNIT II,-HILL TOP ORDINARY ML VIAL
LIMITED ALS LTD INDUSTRIAL ESTATE, VIALS
KALAN, BADDI -HP
1820 NDA/MAL/H AJANTA ABACUS ZAHA- AZITHROMYCI 500MG AJANTA PHARMA LIMITED INDIA ORAL SOLID 1.0X1.0X3 7/1/2009
DP/3551 PHARMA LTD PHARMA 500MG N PAITHAN- ORDINARY .0 TABLET
(AFRICA) MANUFACTURING UNIT B- FILM- BLISTER,1.
LIMITED 4/5/6 MIDC PAITHAN COATED 0X10.0X1.
DISTRICT AURANGABAD TABLETS 0X3.0
431 148 MAHARASTRA TABLET
STATE INDIA BLISTER
1821 NDA/MAL/H VENUS HARLEYS CARBOL CARBOPLATI 150MG/15 VENUS REMEDIES LTD- INDIA PARENTERAL 1.0X20.0 7/1/2008
DP/3552 REMIDIES LTD UGANDA N ML VNIT-11 HILL TOP ORDINARY ML VIAL
LIMITED INDUSTRAL ESTATE VIALS
JHARRUJIRI EPIP INDIA
1822 NDA/MAL/H CIPLA LTD. QUALITY FALCIMON ARTESUNATE 25MG+67. CIPLA LTD UNIT II-A-42 INDIA ORAL SOLID 1.0X3.0 7/1/2014
DP/3553 CHEMICALS LTD - 25/67.5 B/L +AMODIAQUI 5MG MIDC PATALGANGA ORDINARY TABLET
HUMAN NE DISTRICT RAIGAD LAYERED BLISTER,1.
MAHARASHTRA STATE TABLETS 0X25.0X3.
0 TABLET
BLISTER,1.
0X25.0X6.
0 TABLET
BLISTER
1823 NDA/MAL/H REGAL REGAL PHARMA GRISACTIN- GRISEOFULVI 500MG REGAL KENYA ORAL SOLID 1.0X10.0X 7/1/2007
DP/3556 PHARMACEUT (U) LTD 500 N TABLETS PHARMACEUTICALS ORDINARY 10.0
ICALS LTD TABLETS LIMITED -PLOT 7879/18 TABLETS TABLET
OF BABA DOGO ROAD, BLISTER
RUARAKA, NAIROBI
1824 NDA/MAL/H CIPLA LTD QUALITY SEROFLO- SALMETEROL 25MCG + CIPLA LTD.- -PLOT NO INDIA LUNG 1.0X120.0 7/1/2009
DP/3558 CHEMICALS LTD - 250 + 250MCG L/139 TO L/146, VERNA ADMINISTRA METERED
HUMAN FLUTICASONE INDUSTRIAL ESTATE, TION CFC- DOSE
PROPIONATE VERNA, SOUTH GOA FREE CANNISTE
DISTRICT, 403722 GOA METERED- R
DOSE
INHALER
1825 NDA/MAL/H ASTRA ASTRA PHARMA DERMIZOL KETOCONAZO 200MG ASTRA LIFE CARE(INDIA) INDIA ORAL SOLID 1.0X3.0X1 7/1/2009
DP/3560 PHARMA (U) LIMITED LE PVT LTD-PLOT NO. 57/P, ORDINARY 0.0
UGANDA SARKHEJ – BAVLA TABLETS TABLET
LIMITED HIGHWAY, POST. RAJODA BLISTER,1.
– 382220, TALUKA: BAVLA, 0X10.0X10
DIST. AHMEDABAD .0 TABLET
BLISTER
1826 NDA/MAL/H GITTOES GITTOES AGOCILLIN AMPICILLIN 125MG/5 MILAN LABORATORIES INDIA ORAL LIQUID 1.0X100.0 7/1/1998
DP/3561 PHARMACEUT PHARMACEUTIC ORAL TRIHYDRATE ML (INDIA ) PVT LTD-PLOT NO ORDINARY ML
ICALS LIMITED ALS LIMITED SUSPENSIO 63/67/87 J.C.I.E LTD DRY BOTTLE
N KAMOTHE PANVER, NAVI SUSPENSION
MUMBAI,INDIA S/SYRUPS/D
ROPS
1827 NDA/MAL/H ABACUS ABACUS ORAL ANHYDROUS 13.5G + MEDICAMEN BIOTECH LTD- INDIA ORAL SOLID 1.0X20.0X 7/1/2013
DP/3562 PHARMA (A) PHARMA REHYDRATI GLUCOSE + 2.6G + SP-1192, A &B, PHASE –IV, ORDINARY 20.8 G
LTD. (AFRICA) ON SALTS SODIUM 2.9G + INDUSTRIAL AREA POWDERS SACHET
LIMITED CHLORIDE + 1.5G BHIWADI -301019 DIST.
SODIINCITRA ALWAR (RAJASTHAN)
TE +
POTASSIUM
CHLORIDE
1828 NDA/MAL/H EUROLIFE AIVEEN (U) LEVOLIFE LEVOFLOXACI 500MG/10 EUROLIFE HEALTHCARE INDIA PARENTERAL 1.0X100.0 7/1/2010
DP/3563 HEALTHCARE LIMITED N 0ML PVT LTD-BHAGWANPUR ORDINARY ML
PVT LIMITED ROAD, UTTARAKHAND INFUSION BOTTLE
VIALS/BOTTL
ES
1829 NDA/MAL/H GUILIN STAR ARTESUN ARTESUNATE 60 MG GUILIN PHARMACEUTICAL CHINA PARENTERAL 1.0X60.0 7/1/2008
DP/3566 PHARMACEUT PHARMACEUTIC CO LTD--NO. 43 QILIDIAN ORDINARY MG VIAL
ICALS CO.LTD ALS LTD ROAD GUILIN 541004 DRY VIALS + 1*5%
GUANGXI NAHCO3 +
5 ML
NACL
INJECTIO
N
1830 NDA/MAL/H CADILA ABACUS CARBADAC- CARBAMAZEP 200MG CADILA HEALTH CARE LTD- INDIA ORAL SOLID 10.0X10.0 7/1/1997
DP/3569 HEALTH CARE PHARMA 200 INE KUNDAIM INDUSTRIAL ORDINARY TABLET
LIMITED (AFRICA) ESTATE, PLOT NO. 203- TABLETS BLISTER,1.
LIMITED 213, KUNDAIM,GOA-403 0X1000.0
115, INDIA TABLET
CONTAIN
ER
1831 NDA/MAL/H ASTRA ASTRA PHARMA ASTRIM- TRIMETHOPRI 160MG/80 ASTRA LIFE CARE (INDIA) INDIA ORAL SOLID 1.0X10.0X 7/1/2008
DP/3570 PHARMA (U) (U) LIMITED 960 M/SULFAMET 0MG PVT.LTD-PLOT NO. 57/P, ORDINARY 10.0
LIMITED HOXAZOLE SARKHEJ-BAVLA TABLETS TABLET
HIGHWAY, POST RAJODA- BLISTER,1.
382220, TALUKA BAVLA, 0X1000.0
CONTAIN
ER
1832 NDA/MAL/H CADILA KARURI CADIPHEN CHLORPHENI 2MG//80M CADILA INDIA ORAL LIQUID 1.0X60.0 7/1/1997
DP/3571 PHARMACEUT PHARMACEUTIC EXPECTORA RAMINE/GUA G/100MG PHARMACEUTICALS ORDINARY ML
ICALS ALS LTD. NT IFENESIN/AM LIMITED-1389, TRASAD SYRUPS BOTTLE,1.
MONIUM ROAD, DHOLKA- 382225, 0X100.0
CHLORIDE DIST: AHMEDAD, GUJARAT ML
STATE, INDIA BOTTLE
1833 NDA/MAL/H VENUS AARON PARIN-E ENOXAPARIN 40MG/0.4 VENUS REMEDIES LTD -- INDIA PARENTERAL 1.0X2.0 7/1/2008
DP/3573 REMEDIES PHARMACEUTIC SODIUM ML UNIT II HILL TOP ORDINARY ML PRE-
LIMITED ALS LTD INDUSTRIAL ESTATE PRE-FILLED FILLED
JHARMAJRI EPIP PHASE I SYRINGES SYRINGE
BHATOLI KALAN BADDI
(H.P)
1834 NDA/MAL/H CENTAUR GITTOES METOZ 2.5 METOLAZONE 2.5MG CENTAUR PHARMA INDIA ORAL SOLID 1.0X3.0X1 7/1/2007
DP/3574 PHARMACEUT PHARMACEUTIC TABLET TABLETS USP PVT.LIMITED-PLANT I- ORDINARY 0.0
ICALS ALS LIMITED PLOT3,TIVIM INDUSTRIAL TABLETS TABLET
PRIVATE ESTATE,KARASWADA,MAP BLISTER,1.
LIMITED USA GOA INDIA 0X10.0X10
.0 TABLET
BLISTER
1835 NDA/MAL/H PHARMA OMAB UGANDA CEFIX 400 CEFIXIME 400MG PHARMA INTERNATIONAL JORDAN ORAL SOLID 1.0X1.0X5 7/1/2007
DP/3575 INTERNATION LIMITED CAPSULES CO.,-AL-QASTAL AREA, ORDINARY .0
AL CO AIRPORT ROAD, 11941, CAPSULES CAPSULE
AMMAN BLISTER
1836 NDA/MAL/H REMEDICA GOODMAN CINNARON CINNARIZINE 25MG REMEDICA LIMITED- CYPRUS ORAL SOLID 1.0X5.0X1 7/1/2005
BLISTER
1837 NDA/MAL/H ARISTO NORVIK FEXOFEN- FEXOFENADI 120MG ARISTO INDIA ORAL SOLID 1.0X10.0X 7/1/2008
DP/3580 PHARMACEUT ENTERPRISES 120 NE PHARMACEUTICALS PVT ORDINARY 6.0
ICALS PVT LTD LIMITED HYDROCHLOR LTD-PLOT NO 208 NEW FILM- TABLET
IDE INDUSTRIAL AREA N0 11 COATED BLISTER
MANDIDEEP TABLETS
1838 NDA/MAL/H CENTAUR GITTOES METOZ 5 METOLAZONE 5MG CENTAUR PHARMA INDIA ORAL SOLID 1.0X10.0X 7/1/2007
DP/3581 PHARMACEUT PHARMACEUTIC PVT.LTD-PLANT I-PLOT ORDINARY 10.0
ICALS ALS LIMITED 3,TIVIM INDUSTRIAL TABLETS TABLET
PRIVATE ESTATE,KARASWADA,MAP BLISTER,1.
LIMITED USA GOA INDIA 0X3.0X10.
0 TABLET
BLISTER
1839 NDA/MAL/H RENE RENE SULPHADI SULPHADIMI 500MG RENE INDUSTRIES LTD- UGANDA ORAL SOLID 1.0X1000. 7/1/2009
DP/3582 INDUSTRIES INDUSTRIES MIDINE DINE 680,KAMULI,KIREKA ORDINARY 0 TABLET
LIMITED LIMITED KAMPALA,UGANDA TABLETS CONTAIN
ER
1840 NDA/MAL/H DENK BENLE CONSULT SIMVA- SIMVASTATIN 40MG DENK PHARMA GMBH & GERMANY ORAL SOLID 1.0X3.0X1 7/1/2011
DP/3583 PHARMA LIMITED DENK 40 CO-G0 11 STR.1 84529 ORDINARY 0.0
GMBH & CO T,HMONING GERMANY FILM- TABLET
COATED BLISTER
TABLETS
1841 NDA/MAL/H CIRON DRUGS RENE CHLORAMP CHLORAMPH 0.5%W/V CIRON DRUGS AND INDIA OPHTHALMI 1.0X1.0X1 7/1/2007
DP/3584 & PHARMACY LTD HENICOL ENICOL PHARMACEUTICALS PVT C DROPS 0.0 ML
PHARMACEUT EYE DROPS LTD-N-118 M.I.D.C, VIAL
1842 NDA/MAL/H ELYS VELVET AMPILIN AMPICILLIN 250MG ELYS CHEMICAL KENYA ORAL SOLID 1.0X10.0X 7/1/1997
DP/3585 CHEMICAL PHARMA INDUSTRIES LTD-ROAD 'B' ORDINARY 10.0
INDUSTRIES LIMITED OFF ENTERPRISE ROAD, CAPSULES CAPSULE
LTD INDUSTRIAL AREA BLISTER,1.
NAIROBI 0X1000.0
CAPSULE
CONTAIN
ER
1843 NDA/MAL/H VENUS AARON DOXOL DOCETAXEL 80MG/2ML VENUS REMEDIES LTD, INDIA PARENTERAL 1.0X20.0 7/1/2008
DP/3586 REMEDIES PHARMACEUTIC UNIT II,-HILL TOP ORDINARY ML VIAL
LIMITED ALS LTD INDUSTRIAL ESTATE, VIALS
KALAN, BADDI -HP
1844 NDA/MAL/H ARISTO NORVIK FEXOFEN- FEXOFENADI 180MG ARISTO INDIA ORAL SOLID 1.0X10.0X 7/1/2008
DP/3588 PHARMACEUT ENTERPRISES 180 NE PHARMACEUTICALS PVT ORDINARY 6.0
ICALS PVT LTD LIMITED LTD-PLOT NO 208 NEW FILM- TABLET
INDUSTRIAL AREA N0 11 COATED BLISTER
MANDIDEEP TABLETS
1845 NDA/MAL/H DENK BENLE CONSULT SIMVA- SIMVASTATIN 20MG DENK PHARMA GMBH & GERMANY ORAL SOLID 1.0X3.0X1 7/1/2011
DP/3589 PHARMA LIMITED DENK 20 CO-.GK GOII STR.1 84529 ORDINARY 0.0
GMBH & CO TIHMONING FILM- TABLET
COATED BLISTER
TABLETS
1846 NDA/MAL/H REMEDICA GOODMAN ALFOXAN MEFENAMIC 500MG REMEDICA LIMITED- CYPRUS ORAL SOLID 1.0X10.0X 7/1/2004
DP/3590 LTD INTERNATIONAL 500 FC ACID LIMASSOL INDUSTRIAL ORDINARY 10.0
LTD TABLETS ESTATE, AHAR FILM- TABLET
COATED BLISTER
TABLETS
1847 NDA/MAL/H CIRON DRUGS RENE STERILE QUININE 300MG/ML CIRON DRUGS AND INDIA PARENTERAL 1.0X100.0 7/1/2007
DP/3594 & PHARMACY LTD QUININE DIHYDROCHL PHARMACEUTICALS PVT ORDINARY X2.0 ML
PHARMACEUT DIHYDROC ORIDE LIMITED-N-118, N119, AMPOULES AMPOULE
ICALS PVT LTD HLORIDE N113, MIDC TARAPUR
BOISAR DIST THANE
401506, INIDA
1848 NDA/MAL/H UNI MEDICO SHREEJI UMOXIL AMOXICILLIN 125MG/5 UNI MEDICOLABS.- 21-22 INDIA ORAL LIQUID 1.0X100.0 7/1/2015
DP/3595 LAB PHARMACEUTIC 125 TRIHYDRATE ML PHARMACITY SELAQUI ORDINARY ML
ALS LIMITED DEHRADUN 248197 DRY BOTTLE
SUSPENSION
S/SYRUPS/D
ROPS
1849 NDA/MAL/H WIN- SURGIPHARM MYOSPAZ PARACETAM 500MG + WIN- MEDICARE LTD- INDIA ORAL SOLID 1.0X10.0X 7/1/2005
DP/3598 MEDICARE (U) LIMITED OL + 250MG MODIPURAM -250 ORDINARY 10.0
LTD CHLORZOXAZ 110,UTTAR PRAADESH, TABLETS TABLET
ONE INDIA. BLISTER
1850 NDA/MAL/H SK AGE ABACUS HYDROKAN HYDROCORTI 1%W/W SKANT HEALTH CARE LTD - INDIA TOPICAL 1.0X15.0 7/1/2009
DP/3601 EXPORTS PHARMA T SONE 1802-1805 GIDC PHASE III EXTERNAL G TUBE
(AFRICA) ACETATE VAPI GUJARAT CREAMS
LIMITED
1851 NDA/MAL/H ELYS VELVET VUMTREX LEVAMISOLE 40MG/5ML ELYS CHEMICAL KENYA ORAL LIQUID 1.0X30.0 7/1/2003
DP/3603 CHEMICAL PHARMA SYRUP INDUSTRIES LTD-ROAD 'B' ORDINARY ML
INDUSTRIES LIMITED OFF ENTERPRISE ROAD, SYRUPS BOTTLE
LTD INDUSTRIAL AREA
NAIROBI
1852 NDA/MAL/H PHARMA OMAB UGANDA LINOPRIL LISINOPRIL 20MG PHARMA INTERNATIONAL JORDAN ORAL SOLID 1.0X14.0X 7/1/2004
DP/3607 INTERNATION LIMITED DIHYDRATE COMPANY-MAIN STREET, ORDINARY 2.0
AL COMPANY AL QASTAL INDUSTRIAL TABLETS TABLET
AREA AMMAN- JORDAN BLISTER
JORDAN
1853 NDA/MAL/H AMOUN BOOTS ANTINAL NIFUROXAZID 200MG AMOUN EGYPT ORAL SOLID 1.0X2.0X1 7/1/1997
DP/3609 PHARMACEUT PHARMACEUTIC E PHARMACEUTICALS ORDINARY 2.0
ICALS ALS LIMITED COMPANY-1ST CAPSULES CAPSULE
COMPANY INDUSTRIAL ZONE EL BLISTER,1.
OBOUR CITY CAIRO 0X12.0
EGYPT CAPSULE
BLISTER
1854 NDA/MAL/H COSMOS LTD ASTRA PHARMA PROMETHA PROMETHAZI 25MG COSMOS LTD.-RANGWE KENYA ORAL SOLID 10.0X10.0 7/1/1998
DP/3610 (U) LIMITED ZINE NE ROAD; OFF LUNGA LUNGA ORDINARY TABLET
TABLETS BP HYDROCHLOR ROAD. P.O BOX 414 33, TABLETS BLISTER,1.
25MG IDE NAIROBI 0X1000.0
TABLET
CONTAIN
ER,1.0X10
0.0
TABLET
CONTAIN
ER
1855 NDA/MAL/H SHELYS BETA COLDRIL PARACETAM 120MG+1 SHELYS KENYA ORAL LIQUID 1.0X100.0 7/1/2010
DP/3611 PHARMACEUT HEALTHCARE SYRUP OL + MG+10MG PHARMACEUTICALS LTD,- ORDINARY ML
ICALS LTD UGANDA CHLORPHENI NEW BAGAMOYO ROAD, SYRUPS BOTTLE
LIMITED RAMINE + MWENGE, PLOT NO
PSEUDOEPHE 696,BLOCK NO 32,
DRINE P.O.BOX 3016, DAR ES
SALAAM BETA
HEALTHCARE
INTERNATIONAL LIMITED-
PLOT NUMBER LR
209/6554,MOGADISHU
1856 NDA/MAL/H INTAS NORVIK LOSARTAS- LOSARTAN 50MG + INTAS PHARMACEUTICALS INDIA ORAL SOLID 1.0X3.0X1 7/1/2011
DP/3612 PHARMACEUT ENTERPRISES HT POTASSIUM + 12.5MG LIMITED(BIOPHARMA ORDINARY 0.0
ICALS LTD LIMITED HYDROCHLOR DIVISION)-CAMP ROAD TABLETS TABLET
OTHIAZIDE SELAQUI-248197, BLISTER
DEHRADUN
(UTTARAKHAND) INDIA
1857 NDA/MAL/H HETERO LABS AIVEEN (U) ZIDOVUDIN ZIDOVUDINE 50MG/5ML HETERO LABS LTD UNIT III- INDIA ORAL LIQUID 1.0X240.0 7/1/2013
DP/3613 LTD LIMITED E ORAL 22-110 IDA JEEDIMETIA ORDINARY ML
SOLUTION HYDERABAD ANDHRA LIQUIDS BOTTLE
PRADESH ,
1858 NDA/MAL/H RENE RENE ERYTHROR ERYTHROMYC 125MG/5 RENE INDUSTRIES LTD- UGANDA ORAL LIQUID 1.0X100.0 7/1/2008
DP/3614 INDUSTRIES INDUSTRIES EN IN STEARATE ML PLOT 680, KAMULI ROAD, ORDINARY ML
LIMITED LIMITED SUSPENSIO KIREKA, P.O BOX 6034, SUSPENSION BOTTLE
N KAMPALA S
1859 NDA/MAL/H : ALKEM ABACUS ZAXTER MEROPENEM 1G ALKEM LABORATORIES INDIA PARENTERAL 1.0X1.0 G 7/1/2011
DP/3616 LABORATORIE PHARMA LIMITED.-VILLAGE THANA, ORDINARY VIAL
S LIMITED√ (AFRICA) BADDI, TEHSIL- DRY VIALS
LIMITED NALAGARH, DISTT-SOLAN,
(HP), INDIA-173205
1860 NDA/MAL/H ASTRA ASTRA PHARMA CLOXACILLI CLOXACILLIN 500MG CSPC ZHONGNUO CHINA PARENTERAL 1.0X50.0 7/1/2011
DP/3618 PHARMA (U) (U) LIMITED N SODIUM SODIUM PHARMACEUTICAL ORDINARY VIAL
LIMITED (SHIJIAZHUANG)CO. LTD- DRY VIALS CARTON
SHIJIAZHUANG CITY,
HEBEI
PROVINCE(WORKSHOP
406 AND 407)
1861 NDA/MAL/H ERIS LTD BENLE CONSULT CAPTOPRIL CAPTOPRIL 25MG DENK PHARMA, GOLLSTR.,- GERMANY ORAL SOLID 10.0X10.0 7/1/2000
DP/3619 LIMITED DENK -25 1-D-845 529 TITTMONING ORDINARY TABLET
GERMANY TABLETS BLISTER,2.
0X10.0
TABLET
BLISTER,1.
0X10.0
TABLET
BLISTER
1862 NDA/MAL/H REMEDICA GOODMAN HALOXEN HALOPERIDO 10MG REMEDICA LIMITED- CYPRUS ORAL SOLID 1.0X100.0 7/1/2004
DP/3620 LTD INTERNATIONAL 10 TABLETS L BP LIMASSOL INDUSTRIAL ORDINARY TABLET
LTD ESTATE, AHAR TABLETS CONTAIN
ER
1863 NDA/MAL/H ELYS VELVET AMPILIN AMPICILLIN 125MG/5 ELYS CHEMICAL KENYA ORAL LIQUID 1.0X100.0 7/1/1997
DP/3621 CHEMICAL PHARMA ML INDUSTRIES LTD-ROAD 'B' ORDINARY ML
INDUSTRIES LIMITED OFF ENTERPRISE ROAD, DRY BOTTLE
LTD INDUSTRIAL AREA SUSPENSION
NAIROBI S/SYRUPS/D
ROPS
1864 NDA/MAL/H GLAXOSMITH UNITED PROXIMEX CEFUROXIME GLAXOSMITHKLINE UK UNITED ORAL LIQUID 1.0X1.0X5 7/1/2007
DP/3622 KLINE HEALTHCARE A AXETIL 125MG/5 LTD-HARMIRE RD KINGDOM ORDINARY 0.0 ML
PHARMACEUT DISTRIBUTORS ML BARNARD CASTLE DRY BOTTLE
ICAL KENYA LTD DURHAM, DL12DT UNITED SUSPENSION
LTD S/SYRUPS/D
ROPS
1865 NDA/MAL/H AVENTIS SURGIPHARM ORELOX CEFPODOXIM 40MG/5ML SANOFI WINTHROP FRANCE ORAL LIQUID 1.0X100.0 7/1/2011
DP/3624 INTERCONTIN (U) LIMITED E INDUSTRIE-SANOFI ORDINARY ML
ENTAL WINTHROP INDUSTRIE DRY BOTTLE,1.
56, RUE DE CHOISY AU SUSPENSION 0X50.0 ML
BAC S/SYRUPS/D BOTTLE
60205 COMPIÈGNE ROPS
1866 NDA/MAL/H CADILA ABACUS ORIPHEX CEPHALEXIN 250MG SAKAR HEALTHCARE INDIA ORAL SOLID 1.0X10.0X 7/1/1997
DP/3626 HEALTH CARE PHARMA CAPSULES LIMITED-BLOCK NO. 10-13, ORDINARY 10.0
LIMITED (AFRICA) SARKHEJ-BAVLA CAPSULES CAPSULE
LIMITED HIGHWAY, BLISTER
VILL: CHANGODAR, DIST:
AHMEDABAD-382213,
GUJARAT – INDIA.
SPARSH BIO-TECH LTD-
PLOT NO.1 SURVEY
NO.242/234/244, VILLAGE
LAKHABARAD, JAMNAGAR-
361006
1867 NDA/MAL/H OTSUKA REDDYS CELEMIN 5S AMINO 5%W/V+5 OTSUKA INDIA PARENTERAL 1.0X500.0 7/1/2001
DP/3628 PHARMACEUT PHARMA ACIDS/SORBIT %W/V PHARMACEUTICAL INDIA ORDINARY ML
ICAL INDIA LIMITED OL PRIVATE LTD-VILLAGE – INFUSION BOTTLE
PRIVATE VASANA – BAGS
SANAND, AHMADABAD
1868 NDA/MAL/H MODI MUNDI SURGIPHARM UNICONTIN THEOPHYLLIN 600MG MODI MUNDIPHARMA INDIA ORAL SOLID 1.0X10.0X 7/1/2009
DP/3630 PHARMA PVT (U) LIMITED 600 E (PVT) LTD-MEERUT - ORDINARY 10.0
LTD MUZAFFARNAGAR ROAD, TABLETS TABLET
MODIPURAM, UTTAR BLISTER
PRADESH ESTATE
1869 NDA/MAL/H DENK BENLE CONSULT ENA-DENK ENALAPRIL 10MG DENK PHARMA GMBH GERMANY ORAL SOLID 1.0X3.0X1 7/1/2008
DP/3631 PHARMA LIMITED 10 MALEATE &CO.KG-- ORDINARY 0.0
GMBH & CO PRINZREGENTESTR.79.816 TABLETS TABLET
KG 75 MUENCHEN, BLISTER
845529 TITTMONING
GERMANY
1870 NDA/MAL/H GITTOES GITTOES AGOPLUS PARACETAM 500MG+15 AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1.0X2.0X1 7/1/2008
DP/3634 PHARMACEUT PHARMACEUTIC OL+DEXTROM MG+2MG+ NO. 33, SECTOR II, VASAI, ORDINARY 0.0
ICALS LIMITED ALS LIMITED ETHORPHAN 10MG TALUKA INDL. CAPSULES CAPSULE
HCL+ BLISTER
CHLORPHENI
RAMINE+PHE
NYLEPHRINE
HCL
1871 NDA/MAL/H CIRON DRUGS RENE CIROGAN PROMETHAZI 25MG/ML CIRON DRUGS & INDIA PARENTERAL 1.0X10.0X 7/1/2011
DP/3635 & PHARMACY LTD NE PHARMACEUTICALS PVT ORDINARY 10.0X2.0
PHARMACEUT HYDROCHLOR LTD-N-118, N-119 MIDC AMPOULES ML
ICALS PVT LTD IDE TARAPUR BOISAR DIST AMPOULE
THANE 401506
MAHARASHTRA INDIA
1872 NDA/MAL/H SHOSAAN RENE TINODERM MULTI- MULTI- NEM LABORATORIES PVT INDIA TOPICAL 1.0X18.0 7/1/1997
DP/3637 ASIC PACIFIC PHARMACY LTD INGREDIENT INGREDIEN LTD-133 VASAI RD(E) 401 EXTERNAL G TUBE
T 162 SB MARG. LOWER OINTMENTS
PAREL MUMBAI
1873 NDA/MAL/H GLAXO SMITH UNITED PANADOL PARACETAM 500MG GLAXOSMITHKLINE KENYA ORAL SOLID 1.0X11.0X 7/1/2010
DP/3639 KLINE LTD HEALTHCARE ADVANCE OL LIMITED - -78392-00507, ORDINARY 10.0
DISTRIBUTORS VIWANDANI LIKONI ROAD TABLETS TABLET
LTD NAIROBI KENYA BLISTER,1.
0X10.0X10
.0 TABLET
BLISTER,1.
0X2.0X10.
0 TABLET
BLISTER
1874 NDA/MAL/H MODI MUNDI SURGIPHARM TRD- TRAMADOL 100MG MODI MUNDIPHARMA INDIA ORAL SOLID 1.0X5.0X1 7/1/2009
DP/3641 PHARMA PVT (U) LIMITED CONTIN HYDROCHLOR (PVT) LTD-MEERUT - ORDINARY 0.0
LTD 100 IDE MUZAFFARNAGAR ROAD, FILM- TABLET
MODIPURAM, UTTAR COATED BLISTER
PRADESH ESTATE TABLETS
1875 NDA/MAL/H IND-SWIFT PLANET CLARIE 250 CLARITHROM 250MG IND-SWIFT-LTD,-GLOBAL INDIA ORAL SOLID 1.0X10.0X 7/1/2007
DP/3642 PHARMACEUTIC YCIN BUSINESS UNIT, ORDINARY 2.0X7.0
ALS UGANDA JAWAHARPUR, OFF NH-21 FILM- TABLET
LTD DERABASSI COATED BLISTER
TABLETS
1876 NDA/MAL/H TRIVENI AIVEEN (U) NEUROBEX THIAMINE + 250MG + TRIVENI FORMULATIONS INDIA ORAL SOLID 1.0X2.0X1 7/1/2014
DP/3645 FORMULATIO LIMITED RIBOFLAVIN + 15MG + LTD .-PLOT NO. 52, 53,54 ORDINARY 0.0
NS LIMITED PYRIDOXINE + 200MG + ALEAP INDUSTRIAL TABLETS TABLET
CYANOCOBAL 250MG + ESTATE SURAMPALLI BLISTER
AMIN+ FOLIC 500MCG VILLAGE GANNAVARAM
ACID MANDAL KRISHNA (DT)
A.P
1877 NDA/MAL/H GITTOES GITTOES NYSTAGO NYSTATIN 100000 IU AGOG PHARMA LTD-PLOT INDIA ORAL 1.0X30.0 7/1/2008
DP/3647 PHARMACEUT PHARMACEUTIC ORAL NO.33,SECTOR TOPICAL ML
ICALS LIMITED ALS LIMITED SUSPENSIO II,VASAI,TALUKA INDL CO- SUSPENSION BOTTLE
E INDIA
1878 NDA/MAL/H MODI MUNDI SURGIPHARM UNICONTIN THEOPHYLLIN 400MG MODI MUNDIPHARMA INDIA ORAL SOLID 1.0X10.0X 7/1/2009
DP/3648 PHARMA PVT (U) LIMITED 400 E (PVT) LTD-MEERUT - ORDINARY 10.0
LTD MUZAFFARNAGAR ROAD, TABLETS TABLET
MODIPURAM, UTTAR BLISTER
PRADESH ESTATE
1879 NDA/MAL/H AMOUN BOOTS ANTINAL NIFUROXAZID 220MG/5 AMOUN EGYPT ORAL LIQUID 1.0X60.0 7/1/2011
DP/3650 PHARMACEUT PHARMACEUTIC E ML PHARMACEUTICALS ORDINARY ML
ICALS ALS LIMITED COMPANY-1ST SYRUPS BOTTLE
COMPANY INDUSTRIAL ZONE EL
OBOUR CITY, CAIRO
EGYPT
1880 NDA/MAL/H CADILA ABACUS ORIPHEX CEPHALEXIN 125MG/5 SAKAR HEALTHCARE INDIA ORAL LIQUID 1.0X100.0 7/1/1997
DP/3651 HEALTHCARE PHARMA SYRUP ML LIMITED-BLOCK NO. 10-13, ORDINARY ML
LTD (AFRICA) SARKHEJ-BAVLA DRY BOTTLE
LIMITED HIGHWAY, SUSPENSION
VILL: CHANGODAR, DIST: S/SYRUPS/D
AHMEDABAD-382213, ROPS
GUJARAT – INDIA.
SPARSH BIO-TECH LTD-
PLOT NO.1 SURVEY
NO.242/234/244, VILLAGE
LAKHABARAD, JAMNAGAR-
361006
1881 NDA/MAL/H AJANTA ABACUS ARTEFAN ARTEMETHER 80 MG + AJANTA PHARMA LIMITED INDIA ORAL SOLID 1.0X6.0 7/1/2008
DP/3653 PHARMA LTD PHARMA + 480 MG PAITHAN- ORDINARY TABLET
(AFRICA) LUMEFANTRI MANUFACTURING UNIT B- TABLETS BLISTER
LIMITED NE 4/5/6 MIDC PAITHAN (WITH
DISTRICT AURANGABAD AMFM
431 148 MAHARASTRA LOGO),1.0
STATE INDIA X6.0
TABLET
BLISTER
(WITHOU
T AMFM
LOGO),30.
1882 NDA/MAL/H IPCA MEDVIN LUMERAX ARTEMETHER 80MG/480 IPCA LABORATORIES LTD,- INDIA ORAL SOLID 1.0X10.0X 7/1/2011
DP/3656 LABORATORIE PHARMA / MG SEJAVTA,RATLAM 457-002 ORDINARY 1.0X6.0
S LTD LIMITED LUMEFANTRI REG.OFF.48 KANDIVLI TABLETS TABLET
NE IND.ESTATE MUMBAI BLISTER
400067
1883 NDA/MAL/H DAWA SUPER MEDIC DAWASTIN NYSTATIN 100000IU/ DAWA LTD -PLOT KENYA ORAL LIQUID 1.0X30.0 7/1/2009
DP/3657 LIMITED LTD ML NO.7879/8 BABA ROAD ORDINARY ML
RUARAKA NAIROBI SUSPENSION BOTTLE
S
1884 NDA/MAL/H ASTRA ASTRA PHARMA ASTAGRA SILDENAFIL 100MG ASTRA LIFE CARE (INDIA) INDIA ORAL SOLID 1.0X1.0X4 7/1/2010
DP/3660 PHARMA (U) (U) LIMITED CITRATE PVT LTD-57/P,RAJODA ORDINARY .0 TABLET
PVT LTD 382220, BAVLA FILM- BLISTER
AHMEDABAD INDIA COATED
TABLETS
1885 NDA/MAL/H CADILA ABACUS AMLODAC AMLODIPINE 10MG CADILA HEALTHCARE LTD- INDIA ORAL SOLID 10.0X10.0 7/1/2003
DP/3663 HEALTHCARE PHARMA 10 BESYLATE KUNDAIM INDUSTRIAL ORDINARY TABLET
LTD (AFRICA) ESTATE, PLOT NO.203- TABLETS STRIP,1.0X
LIMITED 213, KUNDAIM GOA, 3.0X10.0
403115, INDIA TABLET
BLISTER
1886 NDA/MAL/H MACK SHURIK LTD AZZY AZITHROMYCI 500MG TORQUE INDIA ORAL SOLID 1.0X3.0 7/1/2011
DP/3664 BROWN N PHARMACEUTICALS PVT ORDINARY TABLET
PHARMACEUT LTD-ISAAPUR P.O DAPPAR TABLETS BLISTER
ICALS PVT 140056 INDIA
LIMITED
1887 NDA/MAL/H VIRBAC RSA METRO STROM 50 TRAMADOL 50MG LINCOLN INDIA ORAL SOLID 1.0X10.0X 7/1/2008
DP/3666 (PTY) LTD PHARMACEUTIC HYDROCHLOR PHARMACEUTICAL ORDINARY 10.0
ALS LIMITED IDE LIMITED-TRIMAL ESTATE CAPSULES CAPSULE
KHATRAJ KOLOL,GUJARAT BLISTER
INDIA
1888 NDA/MAL/H GLAXOSMITH UNITED AUGMENTI AMOXICILLIN 200 MG/ 5 SMITHKLINE BEECHAM UNITED ORAL LIQUID 1.0X70.0 7/1/1998
DP/3668 KLINE HEALTHCARE N BD + ML + 28.5 PHARMACEUTICALS,- KINGDOM ORDINARY ML
PHARMACEUT DISTRIBUTORS CLAVULANIC MG/ 5 ML CLARENDON ROAD, DRY BOTTLE,1.
ICAL KENYA LTD ACID WORTHING, WEST SUSPENSION 0X140.0
LTD SUSSEX, BN148QH S/SYRUPS/D ML
ROPS BOTTLE
1889 NDA/MAL/H ABACUS ABACUS CO- SULFAMETHO 200MG/40 MEDICAMEN BIOTECH LTD INDIA ORAL LIQUID 1.0X60.0 7/1/2014
DP/3669 PHARMA (A) PHARMA TRIMOXAZ XAZOLE/TRIM MG - -SP-1192 A&B PHASE IV ORDINARY ML
LTD. (AFRICA) OLE ETHOPRIM INDUSTRIAL AREA SUSPENSION BOTTLE,1.
LIMITED BHIWADI 301019 DIST. S 0X100.0
ALWAR (RAJASTHAN) - ML
INDIA BOTTLE
1890 NDA/MAL/H RENE RENE TETRAREN TETRACYCLIN 250MG RENE INDUSTRIES LTD- UGANDA ORAL SOLID 1.0X1000. 7/1/2000
DP/3670 INDUSTRIES INDUSTRIES CAPSULES E PLOT 680, KAMULI ROAD, ORDINARY 0
LTD LIMITED HYDROCHLOR KIREKA, P.O BOX 6034, CAPSULES CAPSULE
IDE KAMPALA CONTAIN
ER,1.0X10
.0X10.0
CAPSULE
BLISTER
1891 NDA/MAL/H GLAXOSMITH UNITED CLAVULIN AMOXICILLIN 500 MG + SMITHKLINE BEECHAM UNITED ORAL SOLID 1.0X14.0 7/1/2003
DP/3671 KLINE HEALTHCARE TABLETS + 125 MG PHARMACEUTICALS,- KINGDOM ORDINARY TABLET
PHARMACEUT DISTRIBUTORS CLAVULANIC CLARENDON ROAD, TABLETS STRIP,10.0
ICAL KENYA LTD ACID WORTHING, WEST X10.0
LTD SUSSEX, BN148QH TABLET
STRIP,1.0X
20.0
TABLET
STRIP
1892 NDA/MAL/H MODI MUNDI SURGIPHARM NITROCON NITROGLYCER 6.4MG MODI MUNDIPHARMA INDIA ORAL SOLID 1.0X25.0 7/1/2008
DP/3672 PHARMA PVT (U) LIMITED TIN 6.4 IN (PVT) LTD-MEERUT - ORDINARY TABLET
LTD MUZAFFARNAGAR ROAD, SUBLINGUAL CONTAIN
MODIPURAM, UTTAR TABLETS ER
PRADESH ESTATE
1893 NDA/MAL/H REGAL REGAL PHARMA INTAMINE PROMETHAZI 5MG/5ML REGAL KENYA ORAL LIQUID 1.0X60.0 7/1/1997
DP/3674 PHARMACEUT (U) LTD SYRUP NE PHARMACEUTICALS LTD- ORDINARY ML
ICALS LTD HYDROCHLOR BABA DOGO ROAD, SYRUPS BOTTLE,1.
IDE RAURAKA,NAIROBI,KENYA 0X5.0 L
JERRYCAN
1894 NDA/MAL/H ASTRA LIFE ASTRA PHARMA ASCOPAN - HYOSCINE 10MG ASTRA LIFE CARE (INDIA) INDIA ORAL SOLID 1.0X10.0X 7/1/2008
DP/3675 CARE (INDIA) (U) LIMITED SC BUTYLBROMI PVT.LTD-PLOT NO. 57/P, ORDINARY 10.0
PVT LTD DE SARKHEJ-BAVLA OTHER TABLET
HIGHWAY, POST RAJODA- COATED BLISTER,1.
382220, TALUKA BAVLA, TABLETS 0X1000.0
CONTAIN
ER
1895 NDA/MAL/H RENE RENE IBUREN IBUPROFEN 200MG RENE INDUSTRIES LTD- UGANDA ORAL SOLID 1.0X10.0X 7/1/2008
DP/3677 INDUSTRIES INDUSTRIES 680,KAMULI,KIREKA ORDINARY 10.0
LTD LIMITED KAMPALA,UGANDA FILM- TABLET
COATED BLISTER
TABLETS
1896 NDA/MAL/H CIRON DRUGS RENE SUXAMETH SUXAMETHO 50MG/ML CIRON DRUGS AND INDIA PARENTERAL 1.0X10.0X 7/1/2011
DP/3680 & PHARMACY LTD ONIUM NIUM PHARMACEUTICALS PVT ORDINARY 10.0X2.0
PHARMACEUT CHLORIDE CHLORIDE LTD .-N-118, N119, N113, AMPOULES ML
ICALS PVT LTD INJECTION MIDC, TARAPUR, BOISAR, AMPOULE
B.P DIST. THANE 401506,
INDIA
1897 NDA/MAL/H RENE RENE RENEDOL PARACETAM 500MG RENE INDUSTRIES LTD- UGANDA ORAL SOLID 10.0X10.0 7/1/2000
DP/3681 INDUSTRIES INDUSTRIES OL PLOT 680, KAMULI ROAD, ORDINARY TABLET
LTD LIMITED KIREKA, P.O BOX 6034, TABLETS BLISTER,1.
KAMPALA 0X1000.0
TABLET
CONTAIN
ER
1898 NDA/MAL/H CIPLA LTD QUALITY I-PILL LEVONORGES 1.5MG CIPLA LTD.- -PLOT NO INDIA ORAL SOLID 1.0X1.0X1 7/1/2009
DP/3684 CHEMICALS LTD - TREL L/139 TO L/146, VERNA ORDINARY .0 TABLET
HUMAN INDUSTRIAL ESTATE, FILM- BLISTER
VERNA, SOUTH GOA COATED
DISTRICT, 403722 GOA TABLETS
1899 NDA/MAL/H GALPHAR AIVEEN (U) ODICEF CEFTRIAXONE 1G ALKEM LABORATORIES INDIA PARENTERAL 1.0X1.0 G 7/1/2013
DP/3685 LABORATORIE LIMITED LIMITED.-VILLAGE THANA, ORDINARY VIAL
S LTD BADDI, TEHSIL- DRY VIALS
NALAGARH, DISTT-SOLAN,
(HP), INDIA-173205
1900 NDA/MAL/H ACINO GOODMAN NEURORUB MULTIVITAMI MULTINGR ACINO PHARMA AG SWITZERLAN ORAL SOLID 1.0X2.0X1 7/1/1997
DP/3686 PHARMA AG INTERNATIONAL INE N EDIENT (FORMER MEPHA LLC)- D ORDINARY 0.0
LTD DORNACHERSTRASSE 114 FILM- TABLET
P.O BOX 445 CH4147, COATED BLISTER,1.
AESCH/BL TABLETS 0X100.0X1
0.0
TABLET
BLISTER
1901 NDA/MAL/H DAWA SUPER MEDIC DAWA- PROMETHAZI 5MG/5ML DAWA LTD -PLOT KENYA ORAL LIQUID 1.0X60.0 7/1/2010
DP/3687 LIMITED LTD PROM NE HCL NO.7879/8 BABA ROAD ORDINARY ML
RUARAKA NAIROBI SUSPENSION BOTTLE
S
1902 NDA/MAL/H STEDMAN VEERAM NEUTRAFLU ALGNIC ACID 200MG STEDMAN INDIA ORAL LIQUID 1.0X200.0 7/1/2013
DP/3688 PHARMACEUT HEALTHCARE X MINT + +250MG + PHARMACEUTICALS PVT ORDINARY ML
ICALS PVT. (U) LIMITED FLAVOUR MAGNESIUM 250MG + LIMITED-NO. C-4, SIDCO SUSPENSION BOTTLE,1.
LTD HYDROXIDE 250MG + PHARMACEUTICAL S 0X30.0 ML
+ALUMINIUM 125MG COMPLEX, ALATHUR, BOTTLE
HYDROXIDE + THIRUPORUR,
SIMETHICONE
1903 NDA/MAL/H JASSEN-CILAG LABOREX IMODIUM LOPERAMIDE 2MG SPECPHARM HOLDINGS- SOUTH ORAL SOLID 1.0X6.0 7/1/1997
DP/3693 (PTY) LTD UGANDA HCL 15TH ROAD HALFWAY AFRICA ORDINARY CAPSULE
LIMITED HOUSE CAPSULES BLISTER
1904 NDA/MAL/H CADILA ABACUS LORIDIN LORATADINE 10MG CADILANHEALTH CARE INDIA ORAL SOLID 1.0X10.0X 7/1/2002
DP/3694 HEALTHCARE PHARMA RAPITAB LTD ,,;-KUNDAIN ORDINARY 10.0
LTD (AFRICA) INDUSTRIAL ESTATE SOLUBLE TABLET
LIMITED PONDA GOA TABLETS BLISTER
1905 NDA/MAL/H CADILA ABACUS HIPHEN AMOXICILLIN 125MG/5 SPARSH BIO-TECH LTD - INDIA ORAL LIQUID 1.0X100.0 7/1/1997
DP/3698 HEALTHCARE PHARMA SYRUP ML PLOT NO. 1, SURVEY NO. ORDINARY ML
PVT LTD (AFRICA) 42/243/244, VILLAGE DRY BOTTLE
LIMITED LAKHABAVAD POST SUSPENSION
KHODIYAR COLONY S/SYRUPS/D
DISTRICT, JAMNAGAR – ROPS
361006 GUJARAT INDIA
1906 NDA/MAL/H GLOBAL NAPI WIDE SINOPRIL LISINOPRIL 5MG GLOBAL NAPI EGYPT ORAL SOLID 1.0X2.0X1 7/1/2005
DP/3699 PHARMACEUT SPECTRUM 5MG PHARMACEUTICALS -2ND ORDINARY 0.0
ICALS ENTERPRISES TABLETS INDUSTRIAL ZONE, NO.40, TABLETS TABLET
(U) LIMITED ST. NO 18, 6TH OCTOBER, BLISTER
GIZA,
1907 NDA/MAL/H AJANTA ABACUS ATORFIT-20 ATORVASTATI 20MG AJANTA PHARMA LTD--B- INDIA ORAL SOLID 1.0X3.0X1 7/1/2005
DP/3702 PHARMA LTD PHARMA N 4/5/6 MIDC INDUSTRIAL ORDINARY 0.0
(AFRICA) AREA PAITHAN 431 128 TABLETS TABLET
LIMITED AURANGABAD BLISTER
1908 NDA/MAL/H REGAL REGAL PHARMA SONATEC CETYLPYRIDI 0.05%W/V REGAL KENYA ORAL 1.0X250.0 7/1/2014
DP/3703 PHARMACEUI (U) LTD NIUM PHARMACEUTICALS LTD- TOPICAL ML
CALS LTD CHLORIDE BABA DOGO ROAD, LIQUIDS BOTTLE
1909 NDA/MAL/H CADILA ABACUS PENEGRA SILDENAFIL 100MG CADILA HEALTHCARE LTD- INDIA ORAL SOLID 1.0X1.0X4 7/1/2002
DP/3704 HEALTHCARE PHARMA 100 KUNDAIM INDUSTRIAL ORDINARY .0 TABLET
LTD (AFRICA) ESTATE, PLOT NO.203- TABLETS BLISTER,1.
LIMITED 213, KUNDAIM GOA, 0X20.0X4.
403115, INDIA 0 TABLET
BLISTER
1910 NDA/MAL/H GLOBAL NAPI WIDE SORAL TENOXICAM 20MG GLOBAL NAPI EGYPT ORAL SOLID 1.0X10.0 7/1/2005
DP/3705 PHARMACEUT SPECTRUM 20MG PHARMACEUTICALS -2ND ORDINARY CAPSULE
ICALS ENTERPRISES CAPSULES INDUSTRIAL ZONE, NO.40, CAPSULES BLISTER,1.
(U) LIMITED ST. NO 18, 6TH OCTOBER, 0X2.0X10.
GIZA, 0
CAPSULE
BLISTER
1911 NDA/MAL/H INTAS NORVIK OBETAS- ORLISTAT 120MG INTAS PHARMACEUTICALS INDIA ORAL SOLID 1.0X2.0X1 7/1/2010
DP/3707 PHARMACEUT ENTERPRISES 120 LIMITED -CAMP ROAD, ORDINARY 0.0
ICALS LIMITED LIMITED SELAQUI- CAPSULES CAPSULE
UTTARAKHAND, INDIA
1912 NDA/MAL/H SANOFI SURGIPHARM AMARYL M GLIMEPIRIDE 2MG+500 HANDOK INC-78, NORTH ORAL SOLID 1.0X3.0X1 7/1/2015
DP/3708 AVENTIS (U) LIMITED +METFORMIN MG DAEPUNGSANDAN-RO, KOREA ORDINARY 0.0
HYDROCHLOR DAESO-MYEON, FILM- TABLET
IDE EUMSEONG-GUN, COATED BLISTER
CHUNGCHEONGBUK-DO, TABLETS
KOREA
1913 NDA/MAL/H MEDICAL KARURI NIGHT & PARACETAM 500MG/ MEDICAL UNION PHARMA EGYPT ORAL SOLID 1.0X10.0 7/1/2010
DP/3709 UNION PHARMACEUTIC DAY -N OL/ 25MG .CO-ABU-SULTAN ISMAILIA ORDINARY TABLET
PHARMACEUT ALS LTD. DIPHENHYDR +600MG/ EGYPT TABLETS BLISTER
ICALS AMINE 90MG
CHLORIDE +
PARACETAM
OL/
PSEUDOEPHE
DRINE
1914 NDA/MAL/H LABORATORY HARLEYS LACILLIN AMPICILLIN 250MG LABORATORY & ALLIED KENYA ORAL SOLID 1.0X10.0X 7/1/1997
DP/3710 AND ALLIED UGANDA LTD--PLOT NO. 209/ ORDINARY 10.0
LTD LIMITED 10349, OPP. SAMEER CAPSULES CAPSULE
BUSINESS PARK, BLISTER,1.
MOMBASA ROAD P.O. 0X1000.0
BOX 42875, GPO 00100, CAPSULE
ER
1915 NDA/MAL/H BHARAT ABACUS POLY-MXB POLYMYXIN B 500,000 BHARAT SERUMS AND INDIA PARENTERAL 1.0X5.0 7/1/2013
DP/3711 SERUMS AND PHARMA UNITS VACCINES LIMITED,-PLOT ORDINARY ML VIAL
VACCINES LTD (AFRICA) NO. K-27, ADDITIONAL DRY VIALS
LIMITED MIDC,
AMBERNATH (EAST),
INDIA
1916 NDA/MAL/H MICRO LABS PHILLIPS AMLOZAAR LOSARTAN 50MG + MICRO LABS LTD- INDIA ORAL SOLID 1.0X3.0X1 7/1/2010
DP/3712 LTD PHARMACEUTIC POTASSIUM / 5MG 92,SIPCOT INDUSTRIAL ORDINARY 0.0
ALS (UGANDA) AMLODIPINE COMPLEX,HOSUR-635- FILM- TABLET
LIMITED 126(T.N)INDIA COATED BLISTER
TABLETS
1917 NDA/MAL/H GITTOES GITTOES CEFTRIAXO CEFTRIAXONE 1G CSPC ZHONGNUO CHINA PARENTERAL 1.0X1.0 G 7/1/2011
DP/3717 PHARMACEUT PHARMACEUTIC NE SODIUM SODIUM PHARMACEUTICALS LTD- ORDINARY VIAL,1.0X
ICALS LIMITED ALS LIMITED NO. 88, YANGZI ROAD, DRY VIALS 10.0X1.0
SHIJIAZHUANG CITY G VIAL
CHINA
1918 NDA/MAL/H LABORATORY HARLEYS LACILLIN AMPICILLIN 125MG/5 LABORATORY & ALLIED KENYA ORAL LIQUID 1.0X1.0X1 7/7/1997
DP/3723 & ALLIED LTD UGANDA ML LTD--PLOT NO. 209/ ORDINARY 00.0 ML
LIMITED 10349, OPP. SAMEER DRY BOTTLE
BUSINESS PARK, SUSPENSION
MOMBASA ROAD P.O. S/SYRUPS/D
BOX 42875, GPO 00100, ROPS
NAIROBI, KENYA
1919 NDA/MAL/H DAR AL DAWA GAMA EPIGAB PREGABALIN 150MG DAR AL DAWA-NA'UR JORDAN ORAL SOLID 1.0X4.0X1 7/1/2015
DP/3724 DEVELOPMEN PHARMACEUTIC PLANT AMMAN ORDINARY 4.0
INVESTMENT BLISTER
CO LTD
1920 NDA/MAL/H MEDLEY MEDVIN NEW DEXTROMET 10MG/ML MEDLEY INDIA ORAL LIQUID 1.0X100.0 7/1/2007
DP/3725 PHARMACEUT PHARMA TUXIRIL HORPHAN + PHARMACEUTICALS LTD- ORDINARY ML
ICALS LTD LIMITED HBR + 5MG/10ML PLOT NO.18 AND 19, SYRUPS BOTTLE
PHENYLEPHRI + SURVEY NO.378/8 &
NE HCL + 5MG/10ML 379/2, KEBRA INDUSTRIAL
MENTHOL ESTATE, KACHIGAM,
DAMAN-396210 INDIA
1921 NDA/MAL/H ERIS LTD BENLE CONSULT DICLO- DICLOFENAC 50MG DENK PHARMA GMBH GERMANY ORAL SOLID 10.0X10.0 7/1/1998
DP/3728 LIMITED DENK 50 SODIUM &CO.KG-- ORDINARY TABLET
PRINZREGENTESTR.79.816 FILM- BLISTER +
75 MUENCHEN, COATED 1 * 10
GERMANY, GOLLSTR, 1-D- TABLETS SAMPLE
845529 TITTMONING
GERMANY
1922 NDA/MAL/H MEDLEY MEDVIN DECIFEN-SR DICLOFENAC 100MG MEDLEY INDIA ORAL SOLID 1.0X10.0X 7/1/2008
DP/3729 PHARMACEUT PHARMA SODIUM PHARMACEUTICALS LTD- RETARD 20.0
ICALS LIMITED PLOT NO.18 AND 19, ENTERIC- TABLET
SURVEY NO.378/8 & COATED STRIP
ESTATE, KACHIGAM,
DAMAN-396210 INDIA
1923 NDA/MAL/H BAYER SURGIPHARM AVELOX MOXIFLOXACI 400MG BAYER PHARMA AG - GERMANY ORAL SOLID 2.0X5.0 7/1/2001
DP/3730 PHARMA AG (U) LIMITED N 51368 LEVERKUSEN ORDINARY TABLET
HYDROCHLOR GERMANY TABLETS BLISTER,1.
IDE 0X5.0
TABLET
BLISTER
DP/3731 PHARMA LTD PHARMACEUTIC 50MG LIMITED (UNIT III) -AURO ORDINARY CAPSULE
ALS LIMITED HOUSE, 313, BUCHUPALLY, CAPSULES CONTAIN
QUTHUBULLAPAR(M), RR ER
DISTRICT HYDERABAD-
500090, ANDHERA
PRADESH, INDIA.
1925 NDA/MAL/H REGAL REGAL PHARMA ALBASOL ALBENDAZOL 200MG REGAL KENYA ORAL SOLID 1.0X2.0 7/1/2003
DP/3732 PHARMACEUT (U) LTD TABLETS E PHARMACEUTICALS LTD- ORDINARY TABLET
ICALS LTD 200MG BABA DOGO ROAD, TABLETS STRIP
1926 NDA/MAL/H XEPA-SOUL DELMAW ZARICORT MICONAZOLE 2%W/W + XEPA SAUL PATTINSON MALAYSIA TOPICAL 1.0X15.0 7/1/1998
DP/3734 PATTINSON ENTERPRISES CREAM + 1%W/W MALAYSIA-1-5 INDUSTRIAL EXTERNAL G TUBE
LIMITED HYDROCORTI ESTATE 75250 MELAKA CREAMS
SONE MALYSIA
1927 NDA/MAL/H MEDLEY MEDVIN ECOFLOX CIPROFLOXAC 500MG MEDLEY INDIA ORAL SOLID 1.0X10.0X 7/1/2009
DP/3737 PHARMACEUT PHARMA 500 IN PHARMACEUTICALS LTD..- ORDINARY 10.0
ICALS LTD LIMITED TABLETS HYDROCHLOR PLOT NO. 18 & 19, SURVEY FILM- TABLET
IDE NO.378/7&8, COATED BLISTER
379/2&3,ZARI CAUSEWAY TABLETS
ROAD, KACHIGAM,DAMAN
(U.T) 396210-INDIA
1928 NDA/MAL/H KARNATAKA TATA UGANDA AMPICILLIN AMPICILLIN 500MG KARNATAKA ANTIBIOTICS INDIA PARENTERAL 1.0X10.0X 7/1/2010
DP/3738 ANTIBIOTICS LIMITED SODIUM SODIUM & PHARMACEUTICALS LTD- ORDINARY 500.0 MG
& #14, II PHASE PIA, DRY VIALS VIAL,1.0X
PHARMACEUT BANGALORE 560058 50.0X500.
ICALS LTD 0 MG VIAL
1929 NDA/MAL/H CADILA ABACUS ALDREN ALENDRONAT 70MG CADILA HEALTHCARE INDIA ORAL SOLID 1.0X4.0 7/1/2011
DP/3739 HEALTH CARE PHARMA E LIMITED -KUNDAIM ORDINARY TABLET
LTD (AFRICA) INDUSTRIAL ESTATE,PLOT TABLETS BLISTER
LIMITED NO.203-213, KUNDAIM
GOA, 403115,
1930 NDA/MAL/H KAMPALA KAMPALA ACTIZINE CETIRIZINE 10MG KAMPALA UGANDA ORAL SOLID 1.0X15.0X 7/1/2006
DP/3741 PHARMACEUT PHARMACEUTIC HYDROCHLOR PHARMACEUTICAL ORDINARY 10.0
ICAL AL INDUSTRIES IDE INDUSTRIES (1996) LTD- TABLETS TABLET
INDUSTRIES 1996 LIMITED PLOT M 444B STRETCHER BLISTER
(1996) LTD ROAD NTINDA
1931 NDA/MAL/H CADILA ABACUS CARVIL CARVEDILOL 3.125 MG CADILA HEALTHCARE INDIA ORAL SOLID 10.0X10.0 7/1/2006
DP/3743 HEALTH CARE PHARMA 3.125 LIMITED--KUNDAIM ORDINARY TABLET
LTD (AFRICA) INDUSTRIAL ESTATE, PLOT FILM- BLISTER
INDIA
1932 NDA/MAL/H ABBOTT HARLEYS DUPHALAC LACTULOSE 67G/100M ABBOTT BIOLOGICALS B.V - NETHERLAND ORAL LIQUID 1.0X200.0 7/1/2001
DP/3744 HEALTHCARE UGANDA SOLUTION L ABBOTT BIOLOGICALS B.V S ORDINARY ML
PRODUCTS LIMITED VEERWEG 12 8121 AA LIQUIDS BOTTLE,1.
B.V. OLST 0X10.0X15
.0 ML
BOTTLE
1933 NDA/MAL/H MACK SHURIK LTD WINDERM BECLOMETHA 0.025%W/ TORQUE INDIA TOPICAL 1.0X1.0X1 7/1/2008
DP/3745 BROWN CREAM SONE+MICON W + PHARMACEUTICALS LTD- EXTERNAL 5.0 G
PHARMECEUT AZOLE+NEOM 2%W/W + ISSAPUR P.O DAPPAR CREAMS TUBE
ICALS PVT LTD YCIN 0.5%W/W 140506
1934 NDA/MAL/H GITTOES GITTOES BENDRO BENDROFLU 5MG AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1.0X10.0X 7/1/2011
DP/3746 PHARMACEUT PHARMACEUTIC METHIAZIDE NO.33,SECTOR ORDINARY 10.0
E INDIA TABLET
CONTAIN
ER
1935 NDA/MAL/H RENE RENE ALZOL ALBENDAZOL 200MG RENE INDUSTRIES LTD- UGANDA ORAL SOLID 30.0X2.0 7/1/2002
DP/3747 INDUSTRIES INDUSTRIES TABLETS E PLOT 680, KAMULI ROAD, ORDINARY TABLET
LIMITED LIMITED KIREKA, P.O BOX 6034, TABLETS BLISTER
KAMPALA
1936 NDA/MAL/H GITTOES GITTOES AGOSPIRIN ACETYL 100MG AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1.0X1000. 7/1/2010
DP/3748 PHARMACEUT PHARMACEUTIC SALICYLIC NO.33,SECTOR ORDINARY 0 TABLET
ICALS LIMITED ALS LIMITED ACID II,VASAI,TALUKA INDL CO- TABLETS CONTAIN
E INDIA
1937 NDA/MAL/H COSMOS LTD ASTRA PHARMA PAINOTAB PARACETAM 500MG+65 COSMOS LIMITED-- KENYA ORAL SOLID 1.0X10.0X 7/1/2003
DP/3752 (U) LIMITED 200 OL/CAFFEINE MG RANGWA ROAD, OFF ORDINARY 10.0
BOX 414 33, NAIORBI BLISTER
INDUSTRIAL AREA
1938 NDA/MAL/H CENTAUR GITTOES SINAREST OXYMETAZOL 0.025%W/ CENTAUR INDIA NASAL 1.0X10.0 7/1/2006
DP/3754 PHARMACEUT PHARMACEUTIC PD NASAL INE V PHARMACEUTICALS LTD- TOPICAL ML
ICALS ALS LIMITED DROPS HYDROCHLOR PLOT NO.3 TIVIN DROPS BOTTLE
PRIVATE IDE INDUSTRIAL ESTATE
LIMITED KARASWADA 403526
INDIA
1939 NDA/MAL/H REGAL REGAL PHARMA UNITRIM CO- 240MG/5 REGAL KENYA ORAL LIQUID 1.0X100.0 7/1/1997
DP/3757 PHARMACEUI (U) LTD SUSPENSIO TRIMOXAZOL ML PHARMACEUTICALS LTD- ORDINARY ML
CALS LTD N E BABA DOGO ROAD, SUSPENSION BOTTLE,1.
RAURAKA,NAIROBI,KENYA S 0X60.0 ML
BOTTLE
1940 NDA/MAL/H AFRICURE ROYAL PHARMA COMPOUN MAGNESIUM 370MG AFRICURE INDIA ORAL SOLID 1.0X10.0X 7/1/1997
DP/3760 PHARMACEUT 2011 LIMITED D TRISILICATE PHARMACEUTICALS ORDINARY 10.0
ICALS (INDIA) MAGNESIU (INDIA) PRIVATE LIMITED- CHEWABLE TABLET
PRIVATE M PLOT 9-12,DEWAN & SONS TABLETS BLISTER,1.
LIMITED TRISILICATE INDL. AREA, 0X1000.0
INDIA. CONTAIN
ER
1941 NDA/MAL/H COSMOS LTD ASTRA PHARMA RIFACOS- RIFAMPICIN 300 MG COSMOS LIMITED- KENYA ORAL SOLID 1.0X10.0X 7/1/1998
DP/3761 (U) LIMITED 300 RANGWE ROAD, OFF ORDINARY 10.0
LUNGA ROAD - CAPSULES CAPSULE
INDUSTRIAL AREA NAROBI BLISTER,1.
0X1000.0
CAPSULE
CONTAIN
ER
1942 NDA/MAL/H GLAXO UNITED LAMICTAL LAMOTRIGIN 2MG GLAXO WELLCOME INC-ZI UNITED ORAL SOLID 1.0X30.0 7/1/2001
DP/3762 WELLCOME HEALTHCARE 2MG E DE LA PEYENNIERE, 53100, STATES ORDINARY TABLET
(KENYA) LTD DISTRIBUTORS MAYENNE CHEWABLE BOTTLE
LTD TABLETS
1943 NDA/MAL/H ELYS VELVET BUKOL HYOSCINE N- 10MG ELYS CHEMICAL KENYA ORAL SOLID 1.0X10.0X 7/1/1997
DP/3766 CHEMICAL PHARMA TABLETS BUTYLBROMI INDUSTRIES LTD-ROAD 'B' ORDINARY 10.0
INDUSTRIES LIMITED DE OFF ENTERPRISE ROAD, OTHER TABLET
LTD INDUSTRIAL AREA COATED BLISTER,1.
NAIROBI TABLETS 0X1000.0
TABLET
CONTAIN
ER
1944 NDA/MAL/H UNICHEM EUROPA AMPOXIN AMPICILLIN + 250 MG + UNICHEM LABORATORIES INDIA ORAL SOLID 10.0X10.0 7/1/1999
DP/3767 LABORATORIE HEALTHCARE 500 CLOXACILLIN 250 MG LIMITED UNIT II-VILLAGE ORDINARY CAPSULE
S LTD (U) LTD BHATAULI KALAN BADDI CAPSULES BLISTER
DIST SOLAN HIMACHAL
PRADESH 173 205
1945 NDA/MAL/H BAYER SURGIPHARM NIMOTOP NIMODIPINE 30MG BAYER PHARMA AG - GERMANY ORAL SOLID 1.0X10.0X 7/1/2009
DP/3768 PHARMA AG (U) LIMITED 30MG 51368 LEVERKUSEN ORDINARY 10.0
GERMANY FILM- TABLET
COATED BLISTER
TABLETS
1946 NDA/MAL/H AMOUN WIDE XITHRONE AZITHROMYCI 500 MG AMOUN EGYPT ORAL SOLID 1.0X1.0X5 7/1/2005
DP/3770 PHARMACEUT SPECTRUM N PHARMACEUTICALS ORDINARY .0 TABLET
ICALS ENTERPRISES COMPANY-1ST COATED BLISTER
COMPANY (U) LIMITED INDUSTRIAL ZONE EL TABLETS
OBOUR CITY, CAIRO
EGYPT
1947 NDA/MAL/H GITTOES GITTOES AGOBUTOL- SALBUTAMOL 4 MG AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1.0X1000. 7/1/2005
DP/3773 PHARMACEUT PHARMACEUTIC 4 SULPHATE NO.33,SECTOR ORDINARY 0 TABLET
E INDIA TABLET
BLISTER,1.
0X10.0X10
.0 TABLET
BLISTER
1948 NDA/MAL/H UNICHEM EUROPA AMPOXIN AMPICILLIN + 250 MG + UNICHEM LABORATORIES INDIA PARENTERAL 1.0X500.0 7/1/1999
DP/3777 LABORATORIE HEALTHCARE 500 CLOXACILLIN 250 MG LIMITED UNIT II-VILLAGE ORDINARY MG VIAL
S LTD (U) LTD BHATAULI KALAN BADDI DRY VIALS
DIST SOLAN HIMACHAL
PRADESH 173 205
1949 NDA/MAL/H AMOUN WIDE XITHRONE AZITHROMYCI 200MG/5 AMOUN EGYPT ORAL LIQUID 1.0X15.0 7/1/2004
DP/3778 PHARMACEUT SPECTRUM N ML PHARMACEUTICALS ORDINARY ML
ICALS ENTERPRISES COMPANY-1ST SYRUPS BOTTLE
COMPANY (U) LIMITED INDUSTRIAL ZONE EL
OBOUR CITY, CAIRO
EGYPT
1950 NDA/MAL/H CADILA KARURI LOSIUM 50 LOSARTAN 50MG CADILA INDIA ORAL SOLID 1.0X2.0X1 7/1/2011
DP/3779 PHARMACEUT PHARMACEUTIC POTASSIUM PHARMACEUTICALS ORDINARY .0X14.0
ICALS LIMITED ALS LTD. LIMITED-1389, TRASAD TABLETS TABLET
STATE, INDIA
1951 NDA/MAL/H THE ARAB GOODMAN VENTAL SALBUTAMOL 200MCG THE ARAB DRUG EGYPT LUNG 1.0X1.0 7/1/1997
DP/3780 DRUG INTERNATIONAL INHALER COMPANY-5-EL MASSANEI ADMINISTRA CANNISTE
COMPANY LTD ST AL AMEREYA CAIRO TION R CARTON
METERED-
DOSE
INHALER
1952 NDA/MAL/H EGYPTIAN WIDE ALZENTEL ALBENDAZOL 20MG/ML EGYPTIAN EGYPT ORAL LIQUID 1.0X20.0 7/1/2014
DP/3781 INTERNATION SPECTRUM E INTERNATIONAL ORDINARY ML
AL ENTERPRISES PHARMACEUTICAL SUSPENSION BOTTLE
PHARMACEUT (U) LIMITED INDUSTRIES COMPANY- S
COMPANY
1953 NDA/MAL/H LABORATORY HARLEYS LAE-PEN V PHENOXYME 250MG LABORATORY & ALLIED KENYA ORAL SOLID 1.0X1000. 7/1/1997
DP/3782 AND ALLIED UGANDA THYLPENICILL LTD--PLOT NO. 209/ ORDINARY 0 TABLET
LTD LIMITED IN 10349, OPP. SAMEER TABLETS CONTAIN
MOMBASA ROAD P.O. .0X10.0
NAIROBI, KENYA BLISTER
1954 NDA/MAL/H PT NOVELL ECHO NOPRENIA RISPERIDONE 2MG PT NOVELL INDONESIA ORAL SOLID 1.0X3.0X1 7/1/2011
DP/3783 PHARMACEUT PHARMACY (U) PHARMACEUTICALS ORDINARY 0.0
ICAL LIMITED LABORATORIES-JL TABLETS TABLET
LABORATORIE WANAHERANG NO. 35 BLISTER
S NAJUNG UDIK, GUNUNG
PUTRI
BOGOR 16962 INDONESIA
1955 NDA/MAL/H LEBEN ANDYCO CIPIUM CHLORPHENI 2MG/5ML LEBEN LABORATORIES PVT INDIA ORAL LIQUID 1.0X100.0 7/1/2011
DP/3784 LABORATORIE PHARMACY RAMINE LTD --L4 PHASEIII M.I.D.C ORDINARY ML
S PVT LTD (UGANDA) LTD AKOLA 444 104 SYRUPS BOTTLE,1.
MAHARASHTRA 0X60.0 ML
BOTTLE
1956 NDA/MAL/H SPARSH BIO- ABACUS SPENIV PHENOXYME 125MG/5 SPARSH BIO-TECH PVT. INDIA ORAL LIQUID 1.0X100.0 7/1/2004
DP/3787 TECH PVT LTD PHARMA THYLPENICILL ML LTD .-PLOT NO. 1, SURVEY ORDINARY ML
(AFRICA) IN NO. 42/243/244, VILLAGE SUSPENSION BOTTLE
LIMITED LAKHABAVAD POST S
KHODIYAR COLONY
DISTRICT, JAMNAGAR –
1957 NDA/MAL/H BAYER SURGIPHARM LEVITRA VARDENAFIL 5MG BAYER PHARMA AG - GERMANY ORAL SOLID 1.0X1.0X4 7/1/2005
DP/3789 PHARMA AG (U) LIMITED HCL 51368 LEVERKUSEN ORDINARY .0 TABLET
GERMANY TABLETS BLISTER
1958 NDA/MAL/H GITTOES GITTOES AGOFLOX-P PEFLOXACIN 400MG AGOG PHARMA-PLOT 33 INDIA ORAL SOLID 1.0X10.0X 7/1/2005
DP/3790 PHARMACEUT PHARMACEUTIC SECTOR THE VASAI- ORDINARY 10.0
ICALS LIMITED ALS LIMITED TULUKA CO-OP ESTATE TABLETS TABLET
LTD INDIA BLISTER
1959 NDA/MAL/H MEDREICH SURGIPHARM FLEMING AMOXICILLIN 200MG+28 MEDREICH LIMITED UNIT INDIA ORAL LIQUID 1.0X70.0 7/1/2007
DP/3792 PLC (U) LIMITED 228.5 TRIHYDRATE+ .5MG 1-12TH MILE, OLD ORDINARY ML
POTASSIUM MADRAS ROAD, DRY BOTTLE
CLAVULANAT VIRGONAGAR, SUSPENSION
E BANGOLORE-560049 S/SYRUPS/D
ROPS
1960 NDA/MAL/H GITTOES GITTOES AGOMET- METRONIDAZ 200MG AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1.0X10.0X 7/1/2005
DP/3794 PHARMACEUT PHARMACEUTIC 200 OLE NO.33,SECTOR ORDINARY 10.0
E INDIA TABLET
CONTAIN
ER
1961 NDA/MAL/H ELDA REDDYS PROVIVE PROPOFOL 10MG/ML CLARIS LIFE SCIENCES INDIA PARENTERAL 1.0X50.0 7/1/2002
DP/3797 INTERNATION PHARMA 1% LIMITED-CHACHOSWADIII ORDINARY ML
AL DMCC LIMITED VASNA.AHMEDABAD- INFUSION VIAL,1.0X
382213,INDIA VIALS/BOTTL 20.0 ML
ES VIAL
1962 NDA/MAL/H AMOUN WIDE NEUROTON MULTI- N/A AMOUN PHARMACETICAL EGYPT ORAL SOLID 1.0X2.0X1 7/1/2004
DP/3798 PHARMACEUT SPECTRUM TABLET INGREDIENT COMPANY-1ST ORDINARY 0.0
ICAL ENTERPRISES INDUSTRIAL ZONE, EL COATED TABLET
COMPANY (U) LIMITED OBOUR CITY, CAIRO, TABLETS BLISTER
EGYPT
1963 NDA/MAL/H ELYS VELVET FUNGISTIN NYSTATIN 100000 ELYS CHEMICAL INDIA ORAL LIQUID 1.0X30.0 7/1/2002
DP/3801 CHEMICAL PHARMA ORAL IU/ML INDUSTRIES LTD-ROAD 'B' ORDINARY ML
INDUSTRIES LIMITED SUSPENSIO OFF ENTERPRISE ROAD, SUSPENSION BOTTLE
LTD N INDUSTRIAL AREA S
NAIROBI
1964 NDA/MAL/H BAYER SURGIPHARM LEVITRA VARDENAFIL 10 MG BAYER PHARMA AG - GERMANY ORAL SOLID 1.0X1.0X4 7/1/2005
DP/3802 PHARMA AG (U) LIMITED 10MG MONOHYDRO 51368 LEVERKUSEN ORDINARY .0 TABLET
CHLORIDE GERMANY TABLETS BLISTER
TRIHYDRATE
1965 NDA/MAL/H ACINO GOODMAN NEURORUB VITAMIN 100MG+10 MERCKLE GMBH (A SWITZERLAN PARENTERAL 1.0X5.0X3 7/1/1997
DP/3804 PHARMA AG INTERNATIONAL INE IM B1+VITAMIN 0MG+1MG MEMBER OF D ORDINARY I .0 ML
LTD B6+VITAMIN RATIOPHARM GROUP)- M AMPOULE
B12 LUDWIG MERCKLE STR. 3, AMPOULES
89143 BLAUBEUREN
WEILER
1966 NDA/MAL/H INDOCO STAR NOCID GEL ALUMINIUM 400MG/5 INDOCO REMEDIES LTD-B- INDIA ORAL LIQUID 1.0X1.0X1 7/1/2007
DP/3806 REMEDIES PHARMACEUTIC HYDROXIDE + ML + 20, MIDC, WALUJ, ORDINARY 00.0 ML
LTD ALS LTD SIMETHICONE 25MG/5ML AURANGABAB 431136 SUSPENSION BOTTLE,1.
+ + INDIA S 0X1.0X200
MAGNESIUM 100MG/5 .0 ML
ML BOTTLE
1967 NDA/MAL/H GITTOES GITTOES ARTEMETH ARTEMETHER 80MG/ML NINGBO DAHONGYING CHINA PARENTERAL 1.0X6.0X1 7/1/2008
DP/3807 PHARMACEUT PHARMACEUTIC ER PHARMACEUTICALS- ORDINARY I .0 ML
ICALS LIMITED ALS LIMITED INJECTION N0.396 MINZHU RD M AMPOULE
NINGBO CITY ZHEJIANG, AMPOULES
CHINA
1968 NDA/MAL/H MEDLEY MEDVIN COLDRID PARACETAM 500MG+2 MEDLEY INDIA ORAL SOLID 1.0X9.0X1 7/1/2006
DP/3809 PHARMACEUT PHARMA DAY & OL+CHLORPH MG+5MG+ PHARMACEUTICALS LTD- ORDINARY 0.0
ICALS LTD LIMITED NIGHT ENIRAMINE 15MG PLOT NO.18 AND 19, TABLETS TABLET
MALEATE+PH SURVEY NO.378/8 & STRIP
ENYLEPRINE 379/2, KEBRA INDUSTRIAL
HYDROCHLOR ESTATE, KACHIGAM,
IDE + DAMAN-396210 INDIA
CAFFEINE
1969 NDA/MAL/H GALENTIC VITACARE TRIOSPORI NEOMYCIN+ 3.4%W/W GALENTIC PHARMA( INDIA INDIA OPHTHALMI 1.0X5.0 G 7/1/2006
DP/3810 PHARMA LIMITED NE POLYMYXIN B + 5%W/W ) PVT LTD-R-673,MIDC TTC C TUBE
(PVT)LTD OINTMENT +BACITRACIN + RABALE THANE-BELAPUR OINTMENTS
0.4%W/W ROAD,NAVI
1970 NDA/MAL/H KAMPALA KAMPALA B-TONE PHENOBARBI 30MG KAMPALA UGANDA ORAL SOLID 1.0X1000. 7/1/1997
DP/3812 PHARMACEUT PHARMACEUTIC TONE PHARMACEUTICAL ORDINARY 0 TABLET
ICAL AL INDUSTRIES INDUSTRIES (1996) TABLETS CONTAIN
1996 LIMITED ROAD PLOT M444B .0 TABLET
NTINDA KAMPALA BLISTER
1971 NDA/MAL/H MACK SHURIK LTD ACTIPAR PIPERAZINE 500MG/5 TORQUE INDIA ORAL LIQUID 1.0X30.0 7/1/1997
DP/3813 BROWN CITRATE ML PHARMACEUTICALS LTD - ORDINARY ML
PHARMECEUT ISSAPUR P.O DAPPAR SYRUPS BOTTLE
1972 NDA/MAL/H MARTINDALE LABOREX PETHIDINE PETHIDINE 50MG/1ML MARTINDALE UNITED PARENTERAL 1.0X1.0 7/1/1997
DP/3814 PHARMACEUT UGANDA INJECTION PHARMACEUTICAL KINGDOM ORDINARY ML
RMM38UG ENGLAND
1973 NDA/MAL/H ROYAL ROYAL PHARMA BENZYLPEN BENZYLPENIC 1000000 CSPC ZHONGNUO CHINA PARENTERAL 1.0X1.0 7/1/2002
DP/3817 PHARMA 2011 LIMITED ICILLIN ILLIN SODIUM I.U PHARMACEUTICAL ORDINARY MU VIAL
INJECTION (SHIJIAZHUANG)CO. LTD- DRY VIALS
SHIJIAZHUANG CITY,
HEBEI
PROVINCE(WORKSHOP
406 AND 407)
1974 NDA/MAL/H SERUM NORVIK REPOITIN RECOMBINAN 2000 SERUM INSTITUTE OF INDIA PARENTERAL 1.0X0.5 7/1/2012
DP/3818 INSTITUTE OF ENTERPRISES T HUMAN I.U/0.5ML INDIA LTD-212/2 ORDINARY ML
INDIA LTD. LIMITED ERYTHROPOI HADAPSAR, PUNE, 411028, PRE-FILLED VIAL,1.0X
ETIN INDIA SYRINGES 0.5 ML
PRE-
FILLED
SYRINGE
1975 NDA/MAL/H PHARMATHE GOODMAN STRADUME ALLOPURINOL 100MG PHARMATHEN S.A-- GREECE ORAL SOLID 1.0X25.0 7/1/1997
DP/3819 N LTD INTERNATIONAL L 6,DERVENAKION STR .153 ORDINARY TABLET
LTD 51,PALLINI,AHICA GREECE TABLETS BLISTER,1.
0X28.0
TABLET
BLISTER
1976 NDA/MAL/H UNI MEDICO SHREEJI UMOXIL AMOXICILLIN 250MG UNI MEDICOLABS.- 21-22 INDIA ORAL SOLID 1.0X10.0X 7/1/2015
DP/3825 LAB PHARMACEUTIC 250 PHARMACITY SELAQUI ORDINARY 10.0
ALS LIMITED DEHRADUN 248197 CAPSULES CAPSULE
BLISTER
1977 NDA/MAL/H AJANTA ABACUS ATORFIT-10 ATORVASTATI 10MG AJANTA PHARMA LIMITED INDIA ORAL SOLID 1.0X6.0X1 7/1/2005
DP/3827 PHARMA LTD PHARMA N PAITHAN- ORDINARY 0.0
(AFRICA) MANUFACTURING UNIT B- TABLETS TABLET
LIMITED 4/5/6 MIDC PAITHAN BLISTER,1.
DISTRICT AURANGABAD 0X3.0X10.
431 148 MAHARASTRA 0 TABLET
STATE INDIA BLISTER
1978 NDA/MAL/H BETA BETA BETACOOL DRIED 300MG / BETA HEALTHCARE KENYA ORAL SOLID 1.0X2.0X5 7/1/2006
DP/3829 HEALTHCARE HEALTHCARE ALUMINUM 25MG / INTERNATIONAL LTD - - ORDINARY 0.0
UGANDA UGANDA HYDROXIDE/ 50MG / PLOT TABLETS TABLET
LIMITED LIMITED MAGNESIUM 25MG NO.209/6554,MOGADISHU STRIP
HYDROXIDE ROAD,OFF LUNGA LUNGA
/MAGNESIUM INDUSTRIAL AREA,
ALUMINUM P.O.BOX 42569-001000
SILICATE/SIM NAIROBI,KENYA
ETHICANE
1979 NDA/MAL/H ABBVIE (PTY) MEDICAL ALUVIA LOPINAVIR+R 200MG+50 ABBVIE DEUTSCHLAND GERMANY ORAL SOLID 1.0X1.0X1 7/1/2007
DP/3831 LTD ACCESS ITONAVIR MG GMBH & CO. KG.- ORDINARY 20.0
(UGANDA) KNOLLSTASSE 50, D-67061, FILM- TABLET
LIMITED LUDWIGSHAFEN, COATED CONTAIN
GERMANY. TABLETS ER
1980 NDA/MAL/H LABORATORY HARLEYS LABSTATIN NYSTATIN 100.000 I.U LABORATORY & ALLIED KENYA VAGINAL 1.0X15.0 7/1/2000
DP/3833 & ALLIED LTD UGANDA VAGINAL LTD.-PLOT 209/10349 OFF TABLETS PESSARY
LIMITED TABLETS MOMBASA RD NAIROBI STRIP
1981 NDA/MAL/H GLAXOSMITH BETA HEDEX PARACETAM 200MG+40 SMITHKLINE BEECHAM KENYA ORAL SOLID 1.0X20.0 7/1/1997
DP/3835 KLINE LTD HEALTHCARE CAPLETS OL+ASPIRIN+ 0MG+50M (NAIROBI)-NAIROBI, ORDINARY TABLET
UGANDA CAFFEINE G KENYA BETA TABLETS PACK,1.0X
LIMITED ANHYDROUS HEALTHCARE 110.0
INTERNATIONAL LTD - - TABLET
PLOT PACK,1.0X
NO.209/6554,MOGADISHU 100.0
ROAD,OFF LUNGA LUNGA TABLET
INDUSTRIAL AREA, PACK
P.O.BOX 42569-001000
NAIROBI,KENYA
1982 NDA/MAL/H COSMOS LTD ASTRA PHARMA NITROFURA NITROFURAN 100MG COSMOS LIMITED-- KENYA ORAL SOLID 1.0X10.0X 7/1/1998
DP/3837 (U) LIMITED NTOIN TOIN RANGWA ROAD, OFF ORDINARY 10.0
TABLET
CONTAIN
ER,1.0X10
00.0
TABLET
CONTAIN
ER
1983 NDA/MAL/H KAMPALA KAMPALA FLURID ACETAMINOP 500 MG + KAMPALA UGANDA ORAL SOLID 1.0X50.0X 7/1/2006
DP/3839 PHARMACEUT PHARMACEUTIC HEN + 10.5 MG PHARMACEUTICALS ORDINARY 4.0
ICAL AL INDUSTRIES PHENIRAMIN INDUSTIES-PLOT M 444B TABLETS TABLET
INDUSTRIES 1996 LIMITED E MALEATE STRETCHER NTINDA BLISTER
1996 LIMITED
1984 NDA/MAL/H MACK SHURIK LTD TORACTIN CYPROHEPTA 4MG TORQUE INDIA ORAL SOLID 2.0X50.0 7/1/2000
DP/3840 BROWN TABLETS DINE PHARMACEUTICALS LTD- ORDINARY TABLET
PHARMECEUT ISSAPUR P.O DAPPAR TABLETS BLISTER,1.
ICALS PVT LTD 140506 0X1000.0
TABLET
CONTAIN
ER
1985 NDA/MAL/H WOCKHARDT STAR AZIWOK AZITHROMYCI 250MG WOCKHARDT LIMITED -- INDIA ORAL SOLID 1.0X6.0 7/1/1998
DP/3843 LTD PHARMACEUTIC N PLOT 57 VILLAGE ORDINARY CAPSULE
ALS LTD KUNJHAL, JHAMAJRI, CAPSULES BLISTER
BAROTIWALA, BADDI,
TEHSIL-NALAGARH,
DISTRICT SOLAN, 174103
HIMACHAL PRADESH,
INDIA
1986 NDA/MAL/H NOVARTIS SURGIPHARM VOLTAREN DICLOFENAC 100MG NOVARTIS PHARMA STEIN SWITZERLAN ORAL SOLID 1.0X30.0 7/1/1997
DP/3844 PHARMA AG (U) LIMITED RETARD SODIUM AG- D RETARD TABLET
SCHAFFHARVSERTRASSE TABLETS CONTAIN
CH-4332 STEIN ER
SWITZERLAND. NORVATIS
FARMA SPA--VIA
PROVINCIALE SCHITO, 131
1-80052, TORRE
ANNUNCIATA (NA) ITALY
1987 NDA/MAL/H KAMPALA KAMPALA CARDIPAC AMLODIPINE 5MG KAMPALA UGANDA ORAL SOLID 1.0X10.0X 7/1/2011
DP/3845 PHARMACEUT PHARMACEUTIC PHARMECEUTICALS ORDINARY 10.0
ICAL AL INDUSTRIES INDUSTRIES LTD-PLOT TABLETS TABLET
1996 LIMITED NTINDA KLA UGANDA
1988 NDA/MAL/H BAYER SURGIPHARM LEVITRA VARDENAFIL 20 MG BAYER PHARMA AG - GERMANY ORAL SOLID 1.0X1.0X4 7/1/2005
DP/3846 PHARMA AG (U) LIMITED HCL 51368 LEVERKUSEN ORDINARY .0 TABLET
GERMANY TABLETS BLISTER
1989 NDA/MAL/H ROYAL ROYAL PHARMA FORTIFIED FORTIFIED 4 MEGA SHIJIAZHUANG PHARMA CHINA PARENTERAL 1.0X50.0 7/1/2000
DP/3847 PHARMA 2011 LIMITED PROCAINE PROCAINE UNIT GROUP-ZHOUGNUO, ORDINARY VIAL
PENICILLIN PENICILLIN PHARMACEUTICAL DRY VIALS CARTON,1
.0X10.0
VIAL
CARTON
1990 NDA/MAL/H WOCKHARDT STAR AZIWOK AZITHROMYCI 200MG/5 WOCKHARDT LIMITED -- INDIA ORAL LIQUID 1.0X15.0 7/1/1998
DP/3848 LTD PHARMACEUTIC N ML PLOT 57 VILLAGE ORDINARY ML
ALS LTD KUNJHAL, JHAMAJRI, DRY BOTTLE
BAROTIWALA, BADDI, SUSPENSION
TEHSIL-NALAGARH, S/SYRUPS/D
DISTRICT SOLAN, 174103 ROPS
HIMACHAL PRADESH,
INDIA
1991 NDA/MAL/H MICRO LABS PHILLIPS ANGIZAAR- LOSARTAN 50MG + MICRO LABS LTD-92, INDIA ORAL SOLID 1.0X3.0X1 7/1/2009
DP/3850 LTD PHARMACEUTIC H POTASSIUM + 12.5MG SIPCOT INDUSTRIAL ORDINARY 0.0
ALS (UGANDA) HYDROCHLOR COMPLEX HOSU R-635126 TABLETS TABLET
LIMITED OTHIAZIDE (T.N) INDIA BLISTER
1992 NDA/MAL/H MISSION JOINT MEDICAL ZINC ZINC 20MG MEDICAMEN BIOTECH LTD- INDIA ORAL SOLID 1.0X10.0X 7/1/2009
DP/3853 PHARMA A/S STORE (UPMB - SULPHATE SULPHATE SP-1192, A &B, PHASE –IV, ORDINARY 10.0
UCMB) TABLET USP INDUSTRIAL AREA SOLUBLE TABLET
BHIWADI -301019 DIST. TABLETS BLISTER
ALWAR (RAJASTHAN)
1993 NDA/MAL/H INTAS NORVIK LOSARTAS LOSARTAN 50MG INTAS PHARMACEUTICALS INDIA ORAL SOLID 1.0X4.0X7 7/1/2003
DP/3854 PHARMACEUT ENTERPRISES 50 TABLETS POTASSIUM LTD-CAMP ROAD SELAQUI ORDINARY .0 TABLET
ICALS LTD LIMITED DEHRADUN TABLETS BLISTER
1994 NDA/MAL/H UNIQUE TATA UGANDA IFIMOL PARACETAM 10MG/ML UNIQUE INDIA PARENTERAL 1.0X100.0 7/1/2011
DP/3859 PHARMACEUT LIMITED OL PHARMACEUTICAL ORDINARY ML
ICAL LABORATORIES--PLOT NO. INFUSION BOTTLE
LABORATORIE 4 PASE IV, GIDC PANOLI - VIALS/BOTTL
S 394 116 ES
GUJARAT INDIA
1995 NDA/MAL/H GITTOES GITTOES AGOLAC LACTULOSE 3.35MG/5 AGOG PHARMA LTD-PLOT INDIA ORAL LIQUID 1.0X100.0 7/1/2009
DP/3860 PHARMACEUT PHARMACEUTIC ML NO.33,SECTOR ORDINARY ML
PADA,VASAI(E)DIST.THAN BOTTLE,1.
E INDIA 0X200.0
ML
BOTTLE
1996 NDA/MAL/H TORRENT KARURI LAMITOR LAMOTRIGIN 100MG TORRENT INDIA ORAL SOLID 1.0X3.0X1 7/1/2008
DP/3862 PHARMACEUT PHARMACEUTIC 100 E PHAMACEUTICALS LTD- ORDINARY 0.0
ICALS LIMITED ALS LTD. TORRENT TABLETS TABLET
PHAMACEUTICALS LTD BLISTER
INDRAD 382721 DIST
MEHSANA INDIA
1997 NDA/MAL/H ABACUS ABACUS RL COMPOUND 0.6/ 0.25 ABACUS PARENTERAL UGANDA PARENTERAL 1.0X250.0 7/1/2010
DP/3866 PARENTERAL PARENTERAL SODIUM /0.04 / DRUGS LTD.-PLOT NO. ORDINARY ML
DRUGS DRUGS LIMITED LACTATE 0.027 % 114, BLOCK 191, INFUSION BOTTLE,1.
LIMITED INFUSION BP W/V GWAGAMYA, KINGA, VIALS/BOTTL 0X500.0
KAPEKE, ES ML
MUKONO BOTTLE
DP/3867 GROUP PHARMA OINTMENT ONE LTD-B-18,S.I.T.E KARACHI EXTERNAL G
(AFRICA) VALERATE 75700, PAKISTAN CREAMS TUBE,1.0X
LIMITED 5.0 G
TUBE
1999 NDA/MAL/H UNIQUE TATA UGANDA RANTAB RANITIDINE 25MG/ML UNIQUE INDIA PARENTERAL 1.0X10.0X 7/1/1997
DP/3869 PHARMACEUT LIMITED INJECTION PHARMACEUTICAL ORDINARY 2.0 ML
ICALS LABORATORIES (A DIV. OF AMPOULES AMPOULE
LABORATORIE J.B CHEMICALS &
S PHARMACEUTICALS LTD)--
AREA PANOLI 394 116
DIST BHARUCH
2000 NDA/MAL/H INTAS NORVIK DOVERIN DROTAVERIN 40MG INTAS PHARMACEUTICALS INDIA ORAL SOLID 1.0X10.0X 7/1/2008
DP/3871 PHARMACEUT ENTERPRISES 40 E LIMITED-PLOT NO. 457 / ORDINARY 10.0
ICALS LIMITED LIMITED HYDROCHLOR 458 TABLETS TABLET
IDE SARKHEJ-BAVLA BLISTER
HIGHWAY, MATODA - 382
210, TALUKA - SANAND,
DISTRICT - AHMEDABAD,
STATE -
2001 NDA/MAL/H UNICHEM EUROPA ZYNCET CETIRIZINE 5MG/5ML UNICHEM LABORATORIES INDIA ORAL LIQUID 1.0X1.0X6 7/1/2006
DP/3872 LABORATORIE HEALTHCARE SYRUP HYDROCHLOR LTD---C31 & 32 ORDINARY 0.0 ML
S LTD (U) LTD IDE INDUSTRIAL AREA THE SYRUPS BOTTLE
MADRAS
PHARMACEUTICALS-137-B
OLD MAHABALIPURAM
ROAD KARAPAKKAM
CHENNAI 600 096
2002 NDA/MAL/H CIRON DRUGS RENE CHLORPRO CHLORPROM 25MG/ML CIRON DRUGS & INDIA PARENTERAL 1.0X10.0X 7/1/2011
DP/3873 & PHARMACY LTD MAZINE AZINE PHARMACEUTICALS PVT ORDINARY 10.0X2.0
PHARMACEUT INJECTION LTD-N-118, N-119 MIDC AMPOULES ML
ICALS PVT LTD B.P TARAPUR BOISAR DIST AMPOULE
THANE 401506
MAHARASHTRA INDIA
2003 NDA/MAL/H AJANTA ABACUS RIDMAL DIHYDROART 40MG + AJANTA PHARMA LIMITED- INDIA ORAL SOLID 1.0X1.0X1 7/1/2010
DP/3874 PHARMA LTD PHARMA 40/320 EMISININ + 320MG AJANTA PHARMA LIMITED ORDINARY 2.0
31-0 (AFRICA) PIPERAQUINE B-4-5-6, MIDC AREA FILM- TABLET
LIMITED PAITHAN, AURANGABAD, COATED BLISTER,1.
431148 TABLETS 0X1.0X3.0
DIST:AURANGABAD TABLET
MAHARASHTRA, INDIA. BLISTER,1.
0X1.0X8.0
TABLET
BLISTER,1.
0X1.0X9.0
TABLET
2004 NDA/MAL/H PHAMA OMAB UGANDA OPTIMAL(0. TRETINOIN 0.25MG/1 PHARMA INTERNATIONAL JORDAN TOPICAL 1.0X1.0X3 7/1/2005
DP/3875 INTERNATION LIMITED 05% GEL USP G COMPANY .-MAIN STREET, EXTERNAL 0.0 G
AL CO AL QASTAL INDUSTRIAL GELS AND TUBE
AREA AMMAN- JORDAN SOLS
2005 NDA/MAL/H MEDIPHARM MEDIPHARM METRIM CO- MEDIPHARM INDUSTRIES( UGANDA ORAL LIQUID 1.0X60.0 7/1/1997
DP/3879 SALES INDUSTRIES SUSPENSIO TRIMOXAZOL 240MG/5 EA) LTD-PLOT 65 KAKAJJO ORDINARY ML
LIMITED (E.A) LTD N E ML ROAD BWEYOGERERE DRY BOTTLE,1.
P.O.BOX SUSPENSION 0X100.0
6218,KAMPALA,UGANDA S/SYRUPS/D ML
ROPS BOTTLE
2006 NDA/MAL/H SOLVAY HARLEYS FAVERIN FLUVOXAMIN 100MG SOLVAY NETHERLAND ORAL SOLID 1.0X2.0X1 7/1/2008
DP/3880 PHARMACEUT UGANDA E MALEATE PHARMACEUTICALS BV-- S ORDINARY 5.0
ICALS BV LIMITED SOLVAY TABLETS TABLET
PHARMACEUTICALS BV BLISTER
VEERWEG 12 8121 AA,
THE NETHERLANDS
2007 NDA/MAL/H MEDICAL KARURI MOXACIL AMOXYCILLIN 125MG/5 MEDICAL UNION PHARMA EGYPT ORAL LIQUID 1.0X100.0 7/1/2009
DP/3881 UNION PHARMACEUTIC TRIHYDRATE ML .CO-ABU-SULTAN ISMAILIA ORDINARY ML
PHARMACEUT ALS LTD. EGYPT DRY BOTTLE
ICALS SUSPENSION
S/SYRUPS/D
ROPS
2008 NDA/MAL/H UNIQUE PLANET PEDIVIT MULTIINGRE N/A J.B. CHEMICALS AND INDIA ORAL SOLID 3.0X7.0 7/1/1997
DP/3882 PHARMACEUT PHARMACEUTIC FORTE DIENT PHARMACEUTICALS LTD- ORDINARY CAPSULE
ICALS ALS UGANDA CAPSULES J.B. CHEMICALS & CAPSULES BLISTER
LABORATORIE LTD PHARMACEUTICALS LTD,
S 215/216, GIDC, PANOLI,
GUJARAT
2009 NDA/MAL/H NOVARTIS SURGIPHARM MYFORTIC MYCOPHENO 360MG NOVARTIS PHARMA STEIN SWITZERLAN ORAL SOLID 1.0X12.0X 7/1/2006
DP/3883 PHARMA AG (U) LIMITED 360 LATE SODIUM AG- D ORDINARY 10.0
SCHAFFHARVSERTRASSE FILM- TABLET
CH-4332 STEIN COATED BLISTER
SWITZERLAND. NOVARTIS TABLETS
PHARMA PRODUKTIONS
GMBH-OEFLINGER
STR.4479664 WEHR
GERMANY
2010 NDA/MAL/H PHARMA OMAB UGANDA DELOR CLOBETASOL 0.5 MG/G PHARMA INTERNATIONAL JORDAN TOPICAL 1.0X25.0 7/1/2004
DP/3886 INTERNATION LIMITED PROPIONATE COMPANY-MAIN STREET, EXTERNAL G TUBE
AL COMPANY AL QASTAL INDUSTRIAL CREAMS
AREA AMMAN- JORDAN
JORDAN
2011 NDA/MAL/H PFIZER LABOREX LYRICA PREGABALIN 150 MG PFIZER GMBH GERMANY ORAL SOLID 1.0X2.0X1 7/1/2007
DP/3887 LABORATORIE UGANDA 150MG ARZEIMITELWORK - ORDINARY 4.0
S (PTY) LTD LIMITED MOSWALDA 1144 79090 CAPSULES CAPSULE
FREUBURG BLISTER
2012 NDA/MAL/H RENE RENE PYRIREN PYRIDOXINE 25MG RENE INDUSTRIES LTD- UGANDA ORAL SOLID 1.0X1000. 7/1/2014
DP/3888 INDUSTRIES INDUSTRIES HYDROCHLOR PLOT 680, KAMULI ROAD, ORDINARY 0 TABLET
LTD LIMITED IDE KIREKA, P.O BOX 6034, TABLETS CONTAIN
KAMPALA ER,1.0X10
.0X10.0
TABLET
BLISTER
S (PTY) LTD LIMITED MOSWALDA 1144 79090 CAPSULES CAPSULE
FREUBURG BLISTER
2014 NDA/MAL/H PHARMATHE GOODMAN LADININ CIPROFLOXAC 500MG PHARMATHEN S.A-- GREECE ORAL SOLID 1.0X10.0 7/1/1997
DP/3891 N S.A INTERNATIONAL IN 6,DERVENAKION STR .153 ORDINARY TABLET
LTD 51,PALLINI,AHICA GREECE TABLETS BLISTER
2015 NDA/MAL/H MACK SHURIK LTD TETRAX LEVAMISOLE 40MG/5ML TORQUE INDIA ORAL LIQUID 1.0X15.0 7/1/1997
DP/3892 BROWN HYDROCHLOR PHARMACEUTICALS LTD - ORDINARY ML
PHARMECEUT IDE ISSAPUR P.O DAPPAR SUSPENSION BOTTLE
ICALS PVT LTD 140506 S
2016 NDA/MAL/H GITTOES GITTOES EPINEPHRI EPINEPHRINE 1MG/ML NINGBO DAHONGYING CHINA PARENTERAL 1.0X10.0X 7/1/2008
DP/3893 PHARMACEUT PHARMACEUTIC NE HCL PHARMACEUTICAL CO LTD- ORDINARY 1.0 ML
ICALS LIMITED ALS LIMITED INJECTION NO 396, MINGZHU ROAD AMPOULES AMPOULE
USP NINGBO CITY CHINA
2017 NDA/MAL/H MODI MUNDI SURGIPHARM VALCONTIN SODIUM 500MG MODI MUNDIPHARMA INDIA ORAL SOLID 1.0X10.0X 7/1/2010
DP/3896 PHARMA PVT (U) LIMITED 500 VALPROATE PVT. LTD-MEERUT- ORDINARY 10.0
LTD (CONTROLLE MUZAFFARNAGAR ROAD, FILM- TABLET
D RELEASE) MODIPURAM – 250110 COATED BLISTER
2018 NDA/MAL/H DAR AL DAWA GAMA CLAVODAR AMOXICILLIN 875MG/12 DAR AL DAWA-NA'UR JORDAN ORAL SOLID 1.0X2.0X7 7/1/2010
DP/3897 DEVELOPMEN PHARMACEUTIC /CLAVULANIC 5MG PLANT AMMAN ORDINARY .0 TABLET
T AND ALS (U) LIMITED ACID TABLETS BLISTER
INVESTMENT
CO LTD
2019 NDA/MAL/H AJANTA ABACUS FEDATE SODIUM 216.87MG AJANTA PHARMA LIMITED- INDIA ORAL LIQUID 1.0X200.0 7/1/2013
DP/3899 PHARMA LTD PHARMA SYRUP FEREDETATE + 1.5MG + 31-0 MIDC INDUSTRIAL ORDINARY ML
(AFRICA) + PYRIDOXINE 7.5MCG + AREA CHIKALTHANA SYRUPS BOTTLE
LIMITED + 1.5MG 431210 DIST
CYANOCOBAL AURANGABAD
AMIN + FOLIC MAHARASHTRA STATE
ACID
2020 NDA/MAL/H ASTRA ASTRA PHARMA ASTIBA-500 TINIDAZOLE 500MG ASTRA LIFE CARE(INDIA) INDIA ORAL SOLID 1.0X25.0X 7/1/2009
DP/3900 PHARMA (U) LIMITED PVT LTD-57/P, POJODA, ORDINARY 4.0
UGANDA LTD 382220, BOVIA, TABLETS TABLET
AHMEDOBAD, INDIA BLISTER
2021 NDA/MAL/H BAYER SURGIPHARM MICROGYN LEVONORGES 0.15MG + BAYER WEIMER GMBH- FRANCE ORAL SOLID 1.0X3.0X2 7/1/2011
DP/3901 SCHERING (U) LIMITED ON ED FE TREL + 0.03MG DOBEREINERSTRASSE 20, ORDINARY 8.0
PHARMA ETHINYLESTR D-99427 WEIMER TABLETS TABLET
FRANCE ADIOL 2.BAYER PHARMA AG BLISTER
13342, BERLIN BAYER
PHARMA AG -51368
LEVERKUSEN GERMANY
2022 NDA/MAL/H PFIZER LABS UNITED CELSENTRI MARAVIROC 300MG GODECKE GMBH - GERMANY ORAL SOLID 1.0X10.0X 7/1/2008
DP/3903 LTD HEALTHCARE 300MG MOOSWALDALLEE 179090, ORDINARY 10.0X6.0
DISTRIBUTORS FREIBERG GERMANY FILM- TABLET
LTD COATED BLISTER
TABLETS
2023 NDA/MAL/H SWISS SHREEJI LEROLE PANTOPRAZO 40MG SWISS PARENTERALS LTD- INDIA PARENTERAL 1.0X10.0 7/1/2011
DP/3906 PARENTERALS PHARMACEUTIC LE 809 KERALA IND ESTATE ORDINARY ML VIAL
LTD ALS LIMITED GIDC NEAR BAVLA DIST DRY VIALS 1*10ML
AHMEDABAD 382220 0.9%NACL
GUJARAT INDIA AMPOULE
2024 NDA/MAL/H MODI MUNDI SURGIPHARM VALCONTIN SODIUM 200 MG MODI MUNDIPHARMA INDIA ORAL SOLID 1.0X10.0X 7/1/2012
DP/3913 PHARMA PVT (U) LIMITED VALPROATE PVT. LTD-MEERUT- RETARD 10.0
LTD MUZAFFARNAGAR ROAD, FILM- TABLET
MODIPURAM – 250110 COATED BLISTER
2025 NDA/MAL/H GLAXOSMITH UNITED AUGMENTI AMOXICILLIN 875 MG + SMITHKLINE BEECHAM UNITED ORAL SOLID 1.0X2.0X1 7/1/2010
DP/3914 KLINE LTD HEALTHCARE N + 125 MG PHARMACEUTICALS,- KINGDOM ORDINARY .0X7.0
DISTRIBUTORS CLAVULANAT CLARENDON ROAD, FILM- TABLET
LTD E POTASSIUM WORTHING, WEST COATED BLISTER
SUSSEX, BN148QH TABLETS
2026 NDA/MAL/H CIPLA LTD QUALITY PHOTERICI AMPHOTERIC 50MG CIPLA LTD-M-61, M-62 & INDIA PARENTERAL 1.0X50.0 7/1/2011
DP/3920 CHEMICALS LTD - N B IN B M-63, VERNA INDUSTRIAL ORDINARY MG VIAL
HUMAN ESTATE VERNA GOA,INDIA VIALS
2027 NDA/MAL/H SWISS SHREEJI DIAZI DIAZEPAM 5MG/ML SWISS PARENTERALS LTD- INDIA PARENTERAL 1.0X10.0X 7/1/2011
DP/3922 PARENTERALS PHARMACEUTIC 809 KERALA IND ESTATE ORDINARY 2.0 ML
LTD ALS LIMITED GIDC NEAR BAVLA DIST AMPOULES AMPOULE
AHMEDABAD 382220
GUJARAT INDIA
2028 NDA/MAL/H ASTRA ASTRA PHARMA AXASONE DEXAMETHAS 0.5MG ASTRA LIFE CARE(INDIA) INDIA ORAL SOLID 1.0X1000. 7/1/2008
DP/3923 PHARMA (U) LIMITED ONE PVT LTD-PLOT NO. 57/P, ORDINARY 0 TABLET
UGANDA SARKHEJ – BAVLA TABLETS CONTAIN
LIMITED HIGHWAY, POST. RAJODA ER,1.0X10
– 382220, TALUKA: BAVLA, .0X10.0
DIST. AHMEDABAD TABLET
BLISTER
2029 NDA/MAL/H KAMPALA KAMPALA FLUFED PARACETAM 300MG+36 KAMPALA UGANDA ORAL SOLID 1.0X1000. 7/1/1997
DP/3924 PHARMACEUT PHARMACEUTIC OL+PSEUDOE MG+1.5M PHARMECEUTICALS ORDINARY 0 TABLET
ICAL AL INDUSTRIES PHEDRINE G INDUSTRIES LTD.-PLOT TABLETS CONTAIN
INDUSTRIES 1996 LIMITED HYDROCHLOR M444B STRETCHER RD, ER,1.0X10
LTD IDE+TRIPOLID NTINDA KLA UGANDA 0.0
INE TABLET
HYDROCHLOR CONTAIN
IDE ER,1.0X25
0.0
TABLET
CONTAIN
ER,1.0X50
2030 NDA/MAL/H GITTOES GITTOES CALCIUM CALCIUM 10 %W/V NINGBO DAHONGYING CHINA PARENTERAL 1.0X50.0X 7/1/2009
DP/3925 PHARMACEUT PHARMACEUTIC GLUCONAT GLUCONATE PHARMACEUTICALS- ORDINARY 10.0 ML
ICALS LIMITED ALS LIMITED E N0.396 MINZHU RD AMPOULES AMPOULE
INJECTION NINGBO CITY ZHEJIANG,
CHINA
2031 NDA/MAL/H ELYS VELVET MIFUPEN ACETYLSALICY 350 MG + ELYS CHEMICAL KENYA ORAL SOLID 1.0X100.0 7/1/1997
DP/3926 CHEMICAL PHARMA TABLETS LIC ACID + 50 MG INDUSTRIES LTD-ROAD 'B' ORDINARY TABLET
INDUSTRIES LIMITED CAFFEINE OFF ENTERPRISE ROAD, TABLETS STRIP
LTD INDUSTRIAL AREA
NAIROBI
2032 NDA/MAL/H KOTRA ABACUS AXCEL CEPHALEXIN 125MG/5 KOTRA PHARMA (M) SDN. MALAYSIA ORAL LIQUID 1.0X60.0 7/1/2008
DP/3927 PHARMA (M) PHARMA CEPHALEXI MONOHYDRA ML BHD-1 JALAN TTC 12, ORDINARY ML
SDN BHD (AFRICA) N 125 TE CHENG INDUSTRIAL DRY BOTTLE,1.
LIMITED ESTATE, 75250 MELAKA SUSPENSION 0X100.0
MALYSIA S/SYRUPS/D ML
ROPS BOTTLE
2033 NDA/MAL/H RENE RENE MALAREN SULPHADOXI 500MG/25 RENE INDUSTRIES LTD .- UGANDA ORAL SOLID 1.0X1000. 7/1/2004
DP/3928 INDUSTRIES INDUSTRIES NE + MG PLOT 680, KAMULI ROAD, ORDINARY 0 TABLET
LTD LIMITED PYRIMETHAM KIREKA, P.O. BOX 6034, TABLETS BLISTER,1.
INE KAMPALA 0X10.0X10
.0 TABLET
BLISTER,1.
0X50.0X3.
0 TABLET
BLISTER
2034 NDA/MAL/H EGYPTIAN WIDE EPIRAX CLIDINIUM 2.5MG + EGYPTIAN EGYPT ORAL SOLID 1.0X3.0X1 7/1/2008
DP/3932 INTERNATION SPECTRUM TABLETS BROMIDE + 5MG INTERNATIONAL ORDINARY 0.0
AL ENTERPRISES CHLORDIAZEP PHARMACEUTICAL TABLETS TABLET
PHARMACEUT (U) LIMITED OXIDE INDUSTRIES COMPANY- STRIP
COMPANY
2035 NDA/MAL/H TORRENT KARURI TOZAAR-50 LOSARTAN 50MG TORRENT INDIA ORAL SOLID 5.0X10.0 7/1/2001
DP/3933 PHARAMACE PHARMACEUTIC POTASSIUM PHARMACEUTICAL LTD- ORDINARY TABLET
UTICALS LTD ALS LTD. AHMEDABAD-MEHSANA TABLETS BLISTER
HIGHWAY,TALUKA-
AD-382721
2036 NDA/MAL/H CIRON DRUGS RENE ADRENALIN ADRENALINE 1MG/ML CIRON DRUGS & INDIA PARENTERAL 1.0X100.0 7/1/2013
DP/3938 & PHARMACY LTD E PHARMACEUTICALS PVT ORDINARY X1.0 ML
PHARMACEUT INJECTION LTD-N-118, N-119 MIDC AMPOULES AMPOULE
ICALS PVT LTD TARAPUR BOISAR DIST
THANE 401506
MAHARASHTRA INDIA
2037 NDA/MAL/H SWISS SHREEJI CEFONE CEFTRIAXONE 1G SWISS PARENTERALS LTD, INDIA PARENTERAL 1.0X1.0 G 7/1/2011
DP/3945 PARENTERALS PHARMACEUTIC UNIT- II-PLOT NO. 402,412- ORDINARY VIAL
LTD ALS LIMITED 414 KERALA INDUSTRIAL DRY VIALS
ESTATE, GIDC, NEAR
BAVLA, DIST: AHMEDABAD
2038 NDA/MAL/H INTAS NORVIK RABTAS-20 RABEPRAZOL 20 MG INTAS PHARMACEUTICALS INDIA ORAL SOLID 1.0X2.0X1 7/1/2008
DP/3947 PHARMACUIT ENTERPRISES E SODIUM LIMITED(BIOPHARMA ORDINARY 0.0
ICALS LTD LIMITED DIVISION)-CAMP ROAD ENTERIC- TABLET
SELAQUI-248197, COATED BLISTER,1.
DEHRADUN TABLETS 0X3.0X10.
(UTTARAKHAND) INDIA 0 TABLET
INTAS PHARMACEUTICALS BLISTER
LTD .-PLOT NOS. 457, 458
& 191/218P SARKHEJ-
BAVLA HIGHWAY
MATODA SANAND
AHMEDABAD GUJARAT
2039 NDA/MAL/H : ALKEM ABACUS TAXIM-O CEFIXIME 50MG/5ML ALKEM LABORATORIES INDIA ORAL LIQUID 1.0X100.0 7/1/2009
DP/3948 LABORATORIE PHARMA LIMITED.-VILLAGE THANA, ORDINARY ML
S LIMITED√ (AFRICA) BADDI, TEHSIL- DRY BOTTLE,1.
LIMITED NALAGARH, DISTT-SOLAN, SUSPENSION 0X60.0 ML
(HP), INDIA-173205 EAST S/SYRUPS/D BOTTLE
AFRICAN (INDIA) ROPS
OVERSEAS-PLOT NO.1,
PHARMACITY SELAQUI
DEHRADUN – 248011
(U.K), INDIA
2040 NDA/MAL/H REGAL REGAL PHARMA MAGNOMI MAGNESIUM 500MG/5 REGAL KENYA ORAL LIQUID 1.0X100.0 7/1/1997
DP/3949 PHARMACEUT (U) LTD NT TRISILICATE+ ML+250M PHARMACEUTICALS LTD- ORDINARY ML
ICALS LTD SUSPENSIO ALUMINIUM G/5ML BABA DOGO ROAD, SUSPENSION BOTTLE
N HYDROXIDE RAURAKA,NAIROBI,KENYA S
2041 NDA/MAL/H VIRBAC RSA METRO STROM TRAMADOL 50MG/ML SAKAR HEALTH CARE PVT, INDIA PARENTERAL 1.0X10.0X 7/1/2014
DP/3950 (PTY) LTD PHARMACEUTIC HYDROCHLOR LTD-BLOCK NO. 10-13,M.N ORDINARY 2.0 ML
ALS LIMITED IDE DESAI PETROL AMPOULES AMPOULE
PUMP,SARKHEJ-BAVLA
ROAD,VILLAGE
CHANGODAR DIST
AHMEDABAD 382-
213,GUJARAT-INDIA
2042 NDA/MAL/H SPARSH BIO- ABACUS SPAMCLOX AMPICILLIN + 125MG/5 SPARSH BIO-TECH LTD- INDIA ORAL LIQUID 1.0X100.0 7/1/2004
DP/3951 TECH PVT LTD PHARMA CLOXACILLIN ML + PLOT NO.1 SURVEY ORDINARY ML
(AFRICA) 125MG/5 NO.242/234/244, VILLAGE SUSPENSION BOTTLE
LIMITED ML LAKHABARAD, JAMNAGAR- S
361006
2043 NDA/MAL/H MEDREICH SURGIPHARM BIOFERON MULTI N/A MEDREICH STERILAB INDIA ORAL SOLID 1.0X3.0X1 7/1/2007
DP/3961 PLC (U) LIMITED INGREDIENT LIMITED-NO. 4/3, ORDINARY 0.0
AVALAHALI ANJANAPURA OTHER CAPSULE
POST,OFF KANAKAPWA CAPSULES BLISTER
ROAD, BANGALORE
560062 INDIA
2044 NDA/MAL/H NOVARTIS SURGIPHARM COARTEM ARTEMETHER 20MG + NOVARTIS URUNLERI UNITED ORAL SOLID 1.0X2.0X6 7/1/2009
DP/3963 PHARMA (U) LIMITED DISPERSIBL + 120MG TURKEY-YENISEHIR STATES ORDINARY .0 TABLET
SERVICES INC E TABLETS LUMEFANTRI MAHALLESI, IHLARA SOLUBLE BLISTER,1.
NE VADISI SOKAK, NO. 2, TR TABLETS 0X30.0X6.
34912, PENDIK, 0 TABLET
INSTANBUL, TURKEY. BLISTER,1.
0X1.0X6.0
TABLET
BLISTER,2.
0X1.0X24.
0 TABLET
BLISTER,2.
2045 NDA/MAL/H EMCURE HARLEYS OROFER IRON(II) 50MG/5ML EMCURE INDIA ORAL LIQUID 1.0X150.0 7/1/2004
DP/3965 PHARMACEUT UGANDA SYRUP HYDROXIDE PHARMACEUTICALS LTD - ORDINARY ML
ICALS LTD LIMITED POLYMALTOS LANE NO.3 PHASE II,SIDCO SYRUPS BOTTLE
E COMPLEX INDUSTRIAL
COMPLEX,BARI-
BRAHMANA JAMMU 181
133, INDIA
2046 NDA/MAL/H DAWA SUPER MEDIC ASCORBIC ASCORBIC 100 MG DAWA LTD -PLOT KENYA ORAL SOLID 1.0X1000. 7/1/2008
DP/3966 LIMITED LTD ACID ACID NO.7879/8 BABA ROAD ORDINARY 0 TABLET
TABLETS RUARAKA NAIROBI CHEWABLE CONTAIN
TABLETS ER,10.0X1
0.0
TABLET
BLISTER
2047 NDA/MAL/H GITTOES GITTOES AGOCLOX- CLOXACILLIN 125MG/5 MILAN LABORATORIES - INDIA ORAL LIQUID 1.0X100.0 7/1/2011
DP/3967 PHARMACEUT PHARMACEUTIC 125 ML PLOT NOS 63, 67 & 87, ORDINARY ML
ICALS LIMITED ALS LIMITED JAWAHAR CO-OP. DRY BOTTLE
INDUSTRIAL SUSPENSION
ESTATE LTD., S/SYRUPS/D
KAMOTHE, PANVEL (NAVI ROPS
MUMBAI).
2048 NDA/MAL/H PHARCO WIDE FAWAR SODIUM 2.8G + PHARCO EGYPT ORAL LIQUID 1.0X6.5 G 7/1/2002
DP/3969 PHARMACEUT SPECTRUM FRUIT CARBONATE 1.33G + PHARMACEUTICALS LTD- ORDINARY SACHET
ICALS ENTERPRISES EFFERVESC + TARTARIC 0.82G KILO 31 ALEXANDRIA, EFFERVESCE
(U) LIMITED ENT ACID + CITRIC CAIRO DESERT ROAD, NT
GRANULES ACID ARAB REPUBLIC OF EGYPT. POWDERS/G
P. O BOX 12, SIDI GABER, RANULES
ALEXANDRIA EGYPT
2049 NDA/MAL/H LABORATORY HARLEYS LECOTRIM CO- 480MG LABORATORY & ALLIED KENYA ORAL SOLID 1.0X1000. 7/1/1997
DP/3970 AND ALLIED UGANDA TRIMOXAZOL LTD--PLOT NO. 209/ ORDINARY 0 TABLET
LTD LIMITED E 10349, OPP. SAMEER TABLETS CONTAIN
MOMBASA ROAD P.O. .0X10.0
NAIROBI, KENYA BLISTER
2050 NDA/MAL/H VIRCHOW SURGIPHARM VIRIAXONE- CEFTRIAXONE 1G+500MG VIRCHOW HEALTHCARE INDIA PARENTERAL 1.0X1.0 7/1/2013
DP/3971 HEALTHCARE (U) LIMITED SL + PVT LTD,-PLOT NO.130, ORDINARY VIAL
PVT LTD SULBACTAM SILVASSA ROAD, GGID DRY VIALS CARTON
VAPI-396 195, GUJURAT + 10 ML
AMPOULE
WFI
2051 NDA/MAL/H CIPLA LTD. QUALITY FERTOMID- CLOMIPHENE 50MG CIPLA LTD-VERNA INDIA INDIA ORAL SOLID 1.0X10.0 7/1/2007
DP/3972 CHEMICALS LTD - 50 ESTATES 403722 GOA ORDINARY TABLET
HUMAN INDA TABLETS BLISTER
2052 NDA/MAL/H IPCA MEDVIN LARITHER ARTEMETHER 80MG/ML IPCA LABORATORIES LTD,- INDIA PARENTERAL 1.0X6.0X1 7/1/1999
DP/3973 LABORATORIE PHARMA SEJAVTA,RATLAM 457-002 ORDINARY I .0 ML
S LIMITED LIMITED REG.OFF.48 KANDIVLI M AMPOULE
IND.ESTATE MUMBAI AMPOULES ,1.0X8.0X1
400067 .0 ML
AMPOULE
2053 NDA/MAL/H GLAXO SMITH UNITED PENAMOX AMOXYCILLIN 500MG MEDREICH STERILAB LTD- INDIA ORAL SOLID 25.0X20.0 7/1/1997
DP/3981 KLINE LTD HEALTHCARE 12TH MILE, OLD MADRAS ORDINARY CAPSULE
DISTRIBUTORS ROAD, VIRGONAGOR, CAPSULES BLISTER,1
LTD BANGALORE 560049, 0.0X10.0
INDIA CAPSULE
BLISTER,1.
0X500.0
CAPSULE
CONTAIN
ER
2054 NDA/MAL/H GITTOES GITTOES AGOMYCIN ERYTHROMYC 125MG/5 AGOG PHARMA-PLOT 33 INDIA ORAL LIQUID 1.0X1.0X1 7/1/2008
DP/3985 PHARMACEUT PHARMACEUTIC SUSPENSIO IN ESTOLATE ML SECTOR THE VASAI- ORDINARY 00.0 ML
ICALS LIMITED ALS LIMITED N TULUKA CO-OP ESTATE SUSPENSION BOTTLE
LTD INDIA S
2055 NDA/MAL/H REGAL REGAL PHARMA ROHISOL LEVAMISOLE 40MG/5ML REGAL KENYA ORAL LIQUID 1.0X500.0 7/1/1997
DP/3987 PHARMACEUI (U) LTD SYRUP HYDROCHLOR PHARMACEUTICALS LTD- ORDINARY ML
CALS LTD IDE BABA DOGO ROAD, SYRUPS BOTTLE,1.
RAURAKA,NAIROBI,KENYA 0X15.0 ML
BOTTLE
2056 NDA/MAL/H UNICHEM PHILLIPS UNICELIB CELECOXIB 200MG UNICHEM LABORATORIES INDIA ORAL SOLID 1.0X10.0X 7/1/2003
DP/3989 LABORATORIE PHARMACEUTIC 200 LTD UNIT II ,.,-VILLAGE, ORDINARY 10.0
S LTD ALS (UGANDA) BHATAULI KALAN BADDI CAPSULES CAPSULE
LIMITED DIST. SOLAN (H.P) 173 205 BLISTER
UNICHEM LABORATORIES
LTD--PLOT 17 & 18,
PILERNE IND. ESTATE,
PILERNE, BARDEZ GOA-
403511
2057 NDA/MAL/H REGAL REGAL PHARMA UNIXIL AMOXYCILLIN 125MG/5 REGAL KENYA ORAL LIQUID 1.0X1.0X1 7/1/1997
DP/3990 PHARMACEUI (U) LTD SYRUP TRIHYDRATE ML PHARMACEUTICALS LTD- ORDINARY 00.0 ML
CALS LTD BABA DOGO ROAD, DRY BOTTLE
S/SYRUPS/D
ROPS
2058 NDA/MAL/H GITTOES GITTOES AGOFULVIN GRISEOFULVI 500MG AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1.0X10.0X 7/1/2008
DP/3991 PHARMACEUT PHARMACEUTIC N TABLETS NO.33,SECTOR ORDINARY 10.0
E INDIA
2059 NDA/MAL/H SHOSAAN RENE NEM SCAB MULTI- MULTI- NEM LABORATORIES PVT INDIA TOPICAL 1.0X15.0 7/1/1997
DP/3993 ASIC PACIFIC PHARMACY LTD INGREDIENT INGREDIEN LTD-133 VASAI RD(E) 401 EXTERNAL G TUBE
T 162 SB MARG. LOWER OINTMENTS
PAREL MUMBAI
2060 NDA/MAL/H GITTOES GITTOES AGOTOIN NITROFURAN 100MG AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1.0X100.0 7/1/2007
DP/3996 PHARMACEUT PHARMACEUTIC TABLETS TOIN BP NO.33,SECTOR ORDINARY X10.0
E INDIA TABLET
CONTAIN
ER,1.0X10
.0X10.0
TABLET
BLISTER
2061 NDA/MAL/H GITTOES GITTOES AGOKOFF TERBUTALINE 1.25MG/5 AGOG PHARMA LTD-PLOT INDIA ORAL LIQUID 1.0X1.0X1 7/1/2008
DP/3998 PHARMACEUT PHARMACEUTIC SYRUP SULPHATE ML+50MG/ NO.33,SECTOR ORDINARY 00.0 ML
ICALS LIMITED ALS LIMITED +GUAIFENESI /5ML+4MG II,VASAI,TALUKA INDL CO- SYRUPS BOTTLE,1.
N+BROMHEXI /5ML+2.5 OP ESTATE LTD,GAURAI 0X1.0X60.
NE MG/5ML PADA,VASAI(E)DIST.THAN 0 ML
HYDROCHLOR E INDIA BOTTLE
IDE
+LEVOMENTH
OL
2062 NDA/MAL/H AMOUN WIDE APIDONE CHLORPHENA 2MG/5ML AMOUN EGYPT ORAL LIQUID 1.0X125.0 7/1/2008
DP/4000 PHARMACEUT SPECTRUM SYRUP RIMINE + PHARMACEUTICALS ORDINARY ML
ICAL ENTERPRISES MALEATE/DE 0.5MG/5M COMPANY-1ST SYRUPS BOTTLE
COMPANY (U) LIMITED XAMETHASO L INDUSTRIAL ZONE,EL
NE OBOUR CITY, CAIRO,
EGYPT
2063 NDA/MAL/H GITTOES GITTOES AGOCOLD PARACETAM 125MG/5 AGOG PHARMA LTD-PLOT INDIA ORAL LIQUID 1.0X1.0X1 7/1/2008
DP/4001 PHARMACEUT PHARMACEUTIC PLUS SYRUP OL+PHENYLE ML+2.5MG NO.33,SECTOR ORDINARY 00.0 ML
ICALS LIMITED ALS LIMITED PHRINE+CHL /5ML+1MG II,VASAI,TALUKA INDL CO- SYRUPS BOTTLE,1.
ORPHENIRAM /5ML+60M OP ESTATE LTD,GAURAI 0X1.0X60.
INE+SODIUM G /5ML PADA,VASAI(E)DIST.THAN 0 ML
CITRATE E INDIA BOTTLE
2064 NDA/MAL/H GITTOES GITTOES AGOCID ALUMINIUM 250MG/5 AGOG PHARMA LTD-PLOT INDIA ORAL LIQUID 1.0X100.0 7/1/2007
DP/4002 PHARMACEUT PHARMACEUTIC HYDROXIDE+ ML+ NO.33,SECTOR ORDINARY ML
ICALS LIMITED ALS LIMITED MAGNESIUM 250MG/5 II,VASAI,TALUKA INDL CO- SUSPENSION BOTTLE,1.
HYDROXIDE ML OP ESTATE LTD,GAURAI S 0X170.0
PADA,VASAI(E)DIST.THAN ML
E INDIA BOTTLE
2065 NDA/MAL/H TATA TATA UGANDA OXYTOCIN OXYTOCIN 10IU/ML GLAND PHARMA LIMITTED INDIA PARENTERAL 1.0X1.0 7/1/2008
DP/4003 UGANDA LIMITED INJ 143-148-D P PALLY, ORDINARY ML
LIMITED QUTHUBULLAPUL AMPOULES AMPOULE
MANDAL, RANDA REDDY
DIST, HYBERABAD, IN-500
043, INDIA GLAND
PHARMA LTD-PLOT NO. 42
TO 52, SY NO. 166, 171,
DISTRICT 502307,
2066 NDA/MAL/H LINCOLN METRO ANTHEL ALBENDAZOL 400MG LINCOLN INDIA ORAL SOLID 1.0X1.0X1 7/1/2005
DP/4004 PHARMACEUT PHARMACEUTIC E PHARMACEUTICALS LTD-- ORDINARY .0 TABLET
ICALS LTD ALS LIMITED TRIMUL ESTATE AFER CHEWABLE BLISTER
VODSAR VILLAGE KHATJAT TABLETS
GANDHINAGAR INDIA
2067 NDA/MAL/H SANOFI- SURGIPHARM RHINATHIO CARBOCISTEI 5G/100ML NATTERMAN & CIE , GERMANY ORAL LIQUID 1.0X200.0 7/1/2004
DP/4006 AVENTIS (U) LIMITED L 5% FOR NE GMBH ORDINARY ML
ADULTS NATTERMANNALLEE 1 - SYRUPS BOTTLE
SUGARFREE ,50829 COLOGNE ,
GERMANY
2068 NDA/MAL/H SANOFI LABOREX SHANCHOL V.CHOLERA 600 + 300 SHANTHA BIOTECHNICS INDIA PARENTERAL 1.0X10.0X 7/1/2016
DP/4007 PASTEUR UGANDA CHOLERA STRAINS- 01 +300 +300 LTD -SURVEY NO. 274, ORDINARY I 1.5 ML
LIMITED VACCINE INABA + 600 ATHVELLI VILLAGE, M VIALS VIAL (1
FORMALDEHY ELISA MEDCHAL MANDAL – DOSE)
DE KILLED UNITS(EU) 501401, RANGA REDDY
+01 OGAWA OF DISTRICT, ANDHRA
HEAT KILLED LIPOPOLYS PRADESH, INDIA
+ 01 OGAWA ACCHARID
FORMALDEHY E (LPS)
DE KILLED +
01 INABA
HEAT KILLED
2069 NDA/MAL/H KAMPALA KAMPALA PYRI PYRIDOXINE 25MG KAMPALA UGANDA ORAL SOLID 1.0X100.0 7/1/1997
DP/4010 PHARMACEUT PHARMACEUTIC HYDROCHLOR PHARMACEUTICAL ORDINARY TABLET
ICAL AL INDUSTRIES IDE INDUSTRIES (1996) TABLETS CONTAIN
CONTAIN
ER,1.0X50
0.0
TABLET
CONTAIN
ER,1.0X25
2070 NDA/MAL/H ACINO GOODMAN MESPORIN CEFTRIAXONE 2000MG LABESFAL LABORATORIOS PORTUGAL PARENTERAL 1.0X1.0X5 7/1/2004
DP/4012 PHARMA AG INTERNATIONAL 2000 ALMIRO, S.A ,.-ZONA ORDINARY 0.0 ML
LTD INDUSTRIAL DO LABENGO, DRY VIALS VIAL
3465-157 SANTIAGO DE
BESTEIROS
2071 NDA/MAL/H GENO HARLEYS FUSIGEN SODIUM 20MG/G GENO PHARMACEUTICALS INDIA TOPICAL 1.0X10.0 7/1/2011
DP/4014 PHARMACEUT UGANDA FUSIDATE LIMITED- EXTERNAL G TUBE
ICALS PVT LTD LIMITED KARASWADA,MAPUSA OINTMENTS
2072 NDA/MAL/H CADILA KARURI TAMBAC 50 CEFPODOXIM 50MG/5ML CADILA INDIA ORAL LIQUID 1.0X60.0 7/1/2005
DP/4015 PHARMACEUT PHARMACEUTIC E PROXETIL PHARMACEUTICALS ORDINARY ML
ICALS LIMITED ALS LTD. LIMITED-1389, TRASAD DRY BOTTLE,1.
ROAD, DHOLKA- 382225, SUSPENSION 0X1.0X100
DIST: AHMEDAD, GUJARAT S/SYRUPS/D .0 ML
STATE, INDIA ROPS BOTTLE
2073 NDA/MAL/H OTSUKA REDDYS COMPOUN MULTI- MULTI- OTSUKA INDIA PARENTERAL 1.0X500.0 7/1/2007
DP/4016 PHARMACEUT PHARMA D SODIUM INGREDIENT INGREDIEN PHARMACEUTICAL INDIA ORDINARY ML
ICAL INDIA LIMITED LACATE T PRIVATE LTD-VILLAGE – INFUSION BOTTLE
PRIVATE INTRAVEN VASANA – VIALS/BOTTL
LIMITED OUS CHACHARWADIP, TAL: ES
INFUSION SANAND, AHMADABAD
2074 NDA/MAL/H MEDREICH SURGIPHARM ZEBEN ALBENDAZOL 100MG/5 MEDREICH LTD-4/3 OFF INDIA ORAL LIQUID 1.0X20.0 7/1/2007
DP/4018 PLC (U) LIMITED E ML KANAPURA ROAD, ORDINARY ML
AVALAHALLI, A, SUSPENSION BOTTLE
TEJKAMAL S
PHARMACEUTICAL PVT,
SURVEY NO.6/2
ALADAHALLI,SOMAPURAH
OBIL,NELAMANGALA
TALUK,BANGALORE RURAL-
562111,INDIA
2075 NDA/MAL/H SEDICO WIDE FLUCAMOX AMOXICILLIN 500 MG + SEDICO PHARMACEUTICAL EGYPT PARENTERAL 1.0X1.0 G 7/1/2007
DP/4019 PHARMACEUT SPECTRUM 1G + 500 MG CO.-1ST INDUSTRIAL ZONE ORDINARY VIAL
ICAL CO. ENTERPRISES FLUCLOXACIL 6 TH OCTOBER CITY VIALS
(U) LIMITED LIN GIZA,EGYPT
2076 NDA/MAL/H ASTRA LIFE ASTRA PHARMA AZY-500 AZITHROMYCI 500MG ASTRA LIFE CARE (INDIA) INDIA ORAL SOLID 1.0X3.0 7/1/2011
DP/4021 CARE (INDIA) (U) LIMITED N PVT.LTD-PLOT NO. 57/P, ORDINARY TABLET
PVT LTD SARKHEJ-BAVLA TABLETS BLISTER
AHMEDABAD INDIA
2077 NDA/MAL/H CENTAUR GITTOES SINAREST CHLORPHENI 2MG+10M CENTAUR INDIA ORAL LIQUID 1.0X100.0 7/1/1997
DP/4023 PHARMACEUT PHARMACEUTIC LINCTUS RAMINE+DEX G+1.5MG PHARMACEUTICALS PVT ORDINARY ML
ICALS LTD ALS LIMITED TROMETHOR LTD-PLOT NO.3 TIVIN SYRUPS BOTTLE
PHAN+METH INDUSTRIAL ESTATE
ANOL KARASWADA 403526
INDIA
2078 NDA/MAL/H SEDICO WIDE SEDALAC LACTULOSE 3.350G/5M SEDICO PHARMACEUTICAL EGYPT ORAL LIQUID 1.0X120.0 7/1/2007
DP/4024 PHARMACEUT SPECTRUM SYRUP L CO.-1ST INDUSTRIAL ZONE ORDINARY ML
ICAL CO. ENTERPRISES 6 TH OCTOBER CITY SYRUPS BOTTLE
(U) LIMITED GIZA,EGYPT
2079 NDA/MAL/H ABACUS ABACUS XBETA- N BETAMETHAS 0.1%W/V ABACUS PARENTERAL UGANDA OPHTHALMI 1.0X1.0X1 7/1/2011
DP/4030 PARENTERAL PARENTERAL ONE + +0.5%W/V DRUGS LTD-PLOT NO. 114, C DROPS 0.0 ML
DRUGS DRUGS LIMITED NEOMYCIN BLOCK 191, GWAGAMYA, VIAL,1.0X
LIMITED KINGA, KAPEKE, 5.0 ML
MUKONO VIAL
2080 NDA/MAL/H SEDICO WIDE SALBUTAM SALBUTAMOL 2MG/5ML SIDECO PHARMACEUTICAL EGYPT ORAL LIQUID 1.0X1.0X1 7/1/2007
DP/4031 PHARMACEUT SPECTRUM OL SYRUP CO LTD- EGYPT-1ST ORDINARY 20.0 ML
ICAL CO ENTERPRISES INDUSTRIAL ZONE, 6 SYRUPS BOTTLE
(U) LIMITED OCTOBER CITY- EGYPT
2081 NDA/MAL/H JOHNSON&JO PHILLIPS BENYLIN DIPHENHYDR 7MG/5ML JOHNSON&JOHNSON PTY SOUTH ORAL LIQUID 1.0X1.0X1 7/1/2007
DP/4033 HNSON PTY PHARMACEUTIC PAEDIATRIC AMINE LTD.-EDMS BPK241 MAIN AFRICA ORDINARY 00.0 ML
LTD ALS (UGANDA) SYRUP HYDROCHLOR ROAD /HOOFWEG SYRUPS BOTTLE
LIMITED IDE 241,RETREAT 7945,SOUTH
AFRICA
2082 NDA/MAL/H BAYER SURGIPHARM YASMIN DROSPIRENO 3MG+0.3M BAYER PHARMA A.G- GERMANY ORAL SOLID 1.0X1.0X2 7/1/2010
DP/4035 SCHERING (U) LIMITED NE + G MULLERSTRASSE 178, ORDINARY 1.0
PHARMA ETHINYLESTR 13353 BERLIN, GERMANY TABLETS TABLET
ADIOL BLISTER
2083 NDA/MAL/H SHOSAAN RENE PREDSONE- PREDNISOLO 5MG NEM LABORATORIES PVT INDIA ORAL SOLID 1.0X1000. 7/1/2012
DP/4038 ASIC PACIFIC PHARMACY LTD 5 NE LTD-133 KRISHNA ORDINARY 0 TABLET
INDUSTRIAL ESTATE VASAI TABLETS CONTAIN
(E) DIST THANE 401 210 ER,1.0X10
MAHARASHTRA .0X10.0
TABLET
BLISTER
2084 NDA/MAL/H HILTON HEALTHCARE NEOGAB GABAPENTIN 300MG HILTON PHARMA (PVT) PAKISTAN ORAL SOLID 1.0X10.0 7/1/2007
(PVT) LTD KORANGI INDUSTRIAL CAPSULES BLISTER
AREA KARACHI
2085 NDA/MAL/H CADILA ABACUS LEVODAY LEVOFLOXACI 500MG CADILA HEALTH CARE LTD- INDIA ORAL SOLID 1.0X10.0X 7/1/2004
DP/4049 HEALTH CARE PHARMA 500 N KUNDAIM INDUSTRIAL ORDINARY 10.0
LTD (AFRICA) HEMIHYDRAT ESTATE, PLOT NO. 203- TABLETS TABLET
LIMITED E 213, KUNDAIM,GOA-403 BLISTER,1.
115, INDIA 0X2.0X5.0
TABLET
BLISTER,1.
0X20.0X5.
0 TABLET
BLISTER,1.
0X6.0X2.0
X5.0
2086 NDA/MAL/H HETERO AIVEEN (U) EFAVIRENZ EFAVIRENZ 600MG HETERO DRUGS LTD-UNIT- INDIA ORAL SOLID 1.0X30.0 7/1/2010
DP/4052 DRUGS LTD LIMITED 111 NO 22-110 I.D.A ORDINARY TABLET
JEEDIMETTA HYDRABAD FILM- CONTAIN
500055 HETERO LABS COATED ER
LTD. UNIT (V) .-S.N0.439, TABLETS
440, 441& 458, APIIC,
PHARMA SEZ,
POLLEPALLY (VILLAGE),
JADCHERLA (MANDAL)
509301 INDIA.
2087 NDA/MAL/H BAYER SURGIPHARM BAYER ACETYLSALICY 100MG BAYER PHARMA AG-D- GERMANY ORAL SOLID 1.0X3.0X1 7/1/2006
DP/4055 PHARMA AG (U) LIMITED ASPIRIN LIC ACID 51368 LEVERKUSEN, ORDINARY 0.0
CARDIO GERMANY ENTERIC- TABLET
COATED STRIP
TABLETS
2088 NDA/MAL/H LEBEN ANDYCO LAMPY AMPICILLIN 250MG LEBEN LABORATORIES INDIA ORAL SOLID 1.0X1000. 7/1/2011
DP/4057 LABORATORIE PHARMACY PVT. LTD-PLOT NO. L-4, ORDINARY 0
S PVT. LTD., (UGANDA) LTD PHASE-III, MIDC, CAPSULES CAPSULE
INDIA AKOLA– 444 104 (MS). BLISTER,1.
0X10.0X10
.0
CAPSULE
BLISTER,1.
0X100.0X1
0.0
CAPSULE
BLISTER
2089 NDA/MAL/H NORVATIS LABOREX TOBRADEX TOBRAMYCIN 0.3%W/V+ ALCON COUVREUR NV- BELGIUM OPHTHALMI 1.0X5.0 7/1/1997
DP/4060 PHARMA AG- UGANDA /DEXAMETHA 0.1%W/V RIJKSWEG 14, B-2870 C DROPS ML
SWITZERLAN LIMITED SONE PUURS BELGIUM BOTTLE
D
2090 NDA/MAL/H GLAXO SMITH UNITED KIVEXA ABACAVIR 600 MG + GLAXO WELLCOME S.A.- SPAIN ORAL SOLID 1.0X1.0X3 7/1/2006
DP/4062 KLEINE HEALTHCARE SULFATE + 300 MG AVENIDA DE ORDINARY 0.0
LIMITED DISTRIBUTORS LAMIVUDINE EXTREMADURA 3 TABLETS TABLET
LTD 09400 ARANDA DE DUERO CONTAIN
BURGOS ER,1.0X3.
SPAIN 0X10.0
TABLET
BLISTER
2091 NDA/MAL/H GITTOES GITTOES TERAFINE TERBINAFINE 250MG AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1.0X1.0X1 7/1/2010
E INDIA
2092 NDA/MAL/H UNIVERSAL DELMAW UNIBROL AMINOSIDINE 125MG/ML UNIVERSAL CORPORATION KENYA ORAL LIQUID 1.0X1.0X6 7/1/2011
DP/4066 CORPORATIO ENTERPRISES LTD-KIKUYU NAIROBI ORDINARY 0.0 ML
N LTD LIMITED KENYA SYRUPS BOTTLE
2093 NDA/MAL/H CADILA ABACUS CATENOL- ATENOLOL 50MG CADILA HEALTHCARE INDIA ORAL SOLID 1.0X3.0X1 7/1/1997
DP/4067 HEALTH CARE PHARMA 50 TABLETS LIMITED -KUNDAIM ORDINARY 0.0
LIMITED NO.203-213, KUNDAIM COATED BLISTER,1.
GOA, 403115, TABLETS 0X10.0X10
.0 TABLET
BLISTER
2094 NDA/MAL/H AUROBINDO GITTOES LAMIVUDIN LAMIVUDINE 150MG + AUROBINDO PHARMA LTD- INDIA ORAL SOLID 1.0X6.0X1 7/1/2007
DP/4068 PHARMA PHARMACEUTIC E/ZIDOVUD +ZIDOVUDINE 300MG + UNIT III-SURVEY ORDINARY 5.0
LIMITED ALS LIMITED INE/EFAVIR + EFAVIRENZ 600MG NO.313,BACHUPALLY FILM- TABLET
ENZ VILLAGE,QUTHUBULLAPU COATED BLISTER
R MANDAL R.R TABLETS
DISTRICT(A.P),INDIA
2095 NDA/MAL/H UMEDICA VITACARE UMICORT- HYDROCORTI 100MG UMEDICA LABORATORIES INDIA PARENTERAL 1.0X100.0 7/1/2001
DP/4074 LABORATORIE LIMITED 100 SONE PVT, VAPI-PLOT 221, GIDC ORDINARY MG VIAL
S PVT LTD SODIUM II, VAPI-396195, INDIA DRY VIALS
SUCCINATE
2096 NDA/MAL/H DAR AL DAWA GAMA EPIGAB PREGABALIN 75MG DAR AI DAWA-NA UR JORDAN ORAL SOLID 1.0X14.0 7/1/2013
DP/4078 DEVELOPMEN PHARMACEUTIC PLANT,AMMAN,JORDAN ORDINARY CAPSULE
T AND ALS (U) LIMITED CAPSULES BLISTER
INVESTMENT
CO LTD
2097 NDA/MAL/H PHARMA INTL OMAB UGANDA NERVAMIN MECOBALAMI 500MCG PHARMA INTERNATIONAL JORDAN ORAL SOLID 1.0X30.0 7/1/2009
DP/4079 CO.. LIMITED E N CO.-AMMAN JORDAN ORDINARY TABLET
PLANT FILM- CONTAIN
AL-QARTAL MARKETING COATED ER
DEPARTMENT TABLETS
ALBUJAH COMPLEX,
ALJUBAIHA
2098 NDA/MAL/H GLAXO UNITED ZINACEF CEFUROXIME 750MG GLAXO WELLCOME - ITALY PARENTERAL 1.0X750.0 7/1/1997
DP/4085 WELLCOME HEALTHCARE SODIUM VERONA ITALY ORDINARY MG VIAL
(KENYA) LTD DISTRIBUTORS DRY VIALS
LTD
2099 NDA/MAL/H LEBEN ANDYCO KELVIN PARACETAM 120MG/5 LEBEN LABORATORIES PVT INDIA ORAL LIQUID 1.0X60.0 7/1/2008
DP/4086 LABORATORIE PHARMACY SUSPENSIO OL ML LTD --L4 PHASEIII M.I.D.C ORDINARY ML
S PVT LTD (UGANDA) LTD N AKOLA 444 104 SUSPENSION BOTTLE
MAHARASHTRA S
2100 NDA/MAL/H HILTON HEALTHCARE MYTEKA MONTELUKAS 5MG HILTON PHARMA PVT,LTD- INDIA ORAL SOLID 1.0X2.0X7 7/1/2005
DP/4091 PHARMA PVT LTD. TABLETS T SODIUM 13 SECTOR ORDINARY .0 TABLET
LTD 15,KORANG,IND.AREA,8TH TABLETS BLISTER
FLOOR PROGRESSIVE
PLAZA,BEAMONT
RD,KARACHI
2101 NDA/MAL/H PRISMA PHILLIPS FLORANOR SACCHAROM 250MG BHARAT BIOTECH INDIA ORAL LIQUID 1.0X2.0X2 7/1/2010
DP/4092 PHARMACEUT PHARMACEUTIC M YCES INTERNATIONAL LTD- ORDINARY 50.0 MG
ICALS LTD ALS (UGANDA) BOULARDII TURKPALLY SOLUBLE SACHET,1.
LIMITED SHAMEX POWDERS 0X10.0X25
500 078 0.0 MG
MYDERAHAD SACHET
INDIA
2102 NDA/MAL/H LEBEN ANDYCO BECLOMIN BECLOMETHA 0.025%W/ LEBEN LAB PVT LTD-L4 INDIA TOPICAL 1.0X15.0 7/1/2007
DP/4093 LABORATORIE PHARMACY OINTMENT SONE+MICON W + PHASE 111 MIDCS AKOLA EXTERNAL G TUBE
S LTD (UGANDA) LTD AZOLE+NEOM 2%W/W + 444104 MAHARASTRA OINTMENTS
YCIN 0.5%W/W INDIA
2103 NDA/MAL/H LEBEN ANDYCO IBUT-200 IBUPROFEN 200MG LEBEN LAB PVT LTD-L4 INDIA ORAL SOLID 1.0X1000. 7/1/2007
DP/4095 LABORATORIE PHARMACY PHASE 111 MIDCS AKOLA ORDINARY 0 TABLET
S PVT LTD (UGANDA) LTD 444104 MAHARASTRA FILM- CONTAIN
INDIA COATED ER,1.0X10
TABLETS .0X10.0
TABLET
BLISTER,1.
0X100.0X1
0.0
TABLET
BLISTER
2104 NDA/MAL/H GLAXOSMITH UNITED DERMOVAT CLOBETASOL 0.05%W/W GLAXOSMITHKLINE UNITED TOPICAL 1.0X25.0 7/1/1997
DP/4097 KLINE LTD UK HEALTHCARE E PROPIONATE HARMIRE - KINGDOM EXTERNAL G
DISTRIBUTORS GLAXOSMITHKLINE CREAMS TUBE,1.0X
LTD HARMIRE ROAD BARNARD 30.0 G
CASTLE DURHAM TUBE
2105 NDA/MAL/H STRIDES DELMAW EFAVIRENZ EFAVIRENZ 600MG STRIDES SHASUN LTD-N0. INDIA ORAL SOLID 1.0X30.0 7/1/2007
DP/4098 SHASUN ENTERPRISES TABLETS 36/7, ORDINARY TABLET
LIMITED LIMITED SURAGAJAKKHANAHALLI, FILM- CONTAIN
INDLAVADI CROSS, COATED ER
ANEKAL TALUK, TABLETS
BANGALORE
2106 NDA/MAL/H GLENMARK STAR GLEVO I.V LEVOFLOXACI 500MG/10 AMANTA HEALTHCARE INDIA PARENTERAL 1.0X100.0 7/1/2007
DP/4099 PHARMACEUT PHARMACEUTIC N 0ML LIMITED-PLOT NO. 876 ORDINARY ML
ICAL LTD ALS LTD N.H. NO. 8 VILLAGE- INFUSION BOTTLE
HIRIYALA TALUKA, VIALS/BOTTL
MATAR, DIST KHEDA-387 ES
411, GUJARAT
2107 NDA/MAL/H REMEDICA GOODMAN NORETHIST NORETHISTER 5MG REMEDICA LIMITED - CYPRUS ORAL SOLID 1.0X3.0X1 7/1/2007
DP/4100 LTD INTERNATIONAL ERONE ONE AHARNON STREET, ORDINARY 0.0
CYPRUS 3056, CYPRUS
2108 NDA/MAL/H CENTAUR GITTOES AMLOTRUS AMLODIPINE 5MG CENTAUR INDIA ORAL SOLID 1.0X10.0X 7/1/2015
DP/4101 PHARMACEUT PHARMACEUTIC T 5 PHARMACEUTICALS PVT ORDINARY 10.0
ICALS PVT LTD ALS LIMITED LTD-PLOT NO.3 TIVIN TABLETS TABLET
INDUSTRIAL ESTATE BLISTER,1.
KARASWADA 403526 0X3.0X10.
INDIA 0 TABLET
BLISTER
2109 NDA/MAL/H TORRENT KARURI AZULIX-2 GLIMEPIRIDE 2MG TORRENT INDIA ORAL SOLID 1.0X10.0X 7/1/2007
ICALS LTD ALS LTD. INDRAD-382721, TAL KADI, TABLETS TABLET
AHMEDABAD, INDIA BLISTER
2110 NDA/MAL/H GLAXOSMITH UNITED POLIO LIVE 10⁶CCID₅ₒ+ GLAXO SMITHKLINE BELGIUM ORAL LIQUID 1.0X100.0 7/1/2016
DP/4103 KLINE HEALTHCARE SABIN - ATTENUATED 10⁵.⁸CCID₅ₒ BIOLOGICALS S.A-RUE DE ORDINARY X2.0 ML
PHARMACEUT DISTRIBUTORS ONE AND POLIOMYELIT L'INSTITUT, 89 B-1330 DROPS VIAL (20
ICAL KENYA LTD THREE IS VIRUS RIXENSART DOSES)
LTD [ORAL] VACCINE OF
THE SABIN
STRAINS TYPE
1 +TYPE 2
2111 NDA/MAL/H DAWA SUPER MEDIC DAWA- PROMETHAZI 25MG DAWA LTD-BABA DOGO KENYA ORAL SOLID 1.0X1000. 7/1/2009
DP/4104 LIMITED LTD PROM NE HCL ROAD RUARAKA ORDINARY 0 TABLET
COATED CONTAIN
TABLETS ER,1.0X10
.0X10.0
TABLET
BLISTER
2112 NDA/MAL/H ABBOTT HARLEYS DUSPATALI MEBEVERINE 200MG SOLVY PHARMACEUTICALS NETHERLAND ORAL SOLID 1.0X3.0X1 7/1/2008
DP/4107 HEALTHCARE UGANDA N 200 MG LTD-VEERWEG 12 NL 8121 S ORDINARY 0.0
, SAS LIMITED NETHERLANDS TABLETS TABLET
BLISTER
2113 NDA/MAL/H AFRICURE ROYAL PHARMA ERYTHRON ERYTHROMYC 250MG AFRICURE INDIA ORAL SOLID 1.0X10.0X
DP/4112 PHARMACEUT 2011 LIMITED E TABLETS IN PHARMACEUTICALS ORDINARY 10.0
ICALS (INDIA) 250MG (INDIA) PRIVATE LIMITED- TABLETS TABLET
INDIA. CONTAIN
ER
2114 NDA/MAL/H MICRO LABS LABOREX EROSTIN 10 EBASTINE 10 MG MICRO LABS LTD-92, INDIA ORAL SOLID 10.0X10.0 7/1/2005
DP/4113 LTD UGANDA SIPCOT INDUSTRIAL ORDINARY TABLET
LIMITED COMPLEX HOSU R-635126 TABLETS BLISTER
(T.N) INDIA
2115 NDA/MAL/H REGAL REGAL PHARMA RINALIN CHLORPHENI 2MG/5ML REGAL KENYA ORAL LIQUID 1.0X60.0 7/1/1997
DP/4114 PHARMACEUI (U) LTD SYRUP RAMINE PHARMACEUTICALS LTD- ORDINARY ML
CALS LTD MALEATE BABA DOGO ROAD, SYRUPS BOTTLE
2116 NDA/MAL/H REGAL REGAL PHARMA PREDILONE PREDNISOLO 5.0 MG REGAL PHARMACEUICALS KENYA ORAL SOLID 1.0X10.0X 7/1/2007
DP/4115 PHARMACEUT (U) LTD NE LTD-PLOT NO 7879 OFF ORDINARY 10.0
ICALS LTD BABA DOGO ROAD TABLETS TABLET
KUARAKA NAIROBI BLISTER,1.
0X100.0X1
0.0
TABLET
BLISTER
2117 NDA/MAL/H CENTAUR GITTOES OCUREST- PHENYLEPHRI 0.12%+0.0 CENTAUR INDIA OPHTHALMI 1.0X10.0 7/1/2005
DP/4118 PHARMACEUT PHARMACEUTIC AH NE 5%+0.1%+ PHARMACEUTICALS C DROPS ML VIAL
ICALS LTD ALS LIMITED HYDROCHLOR 0.005%+0. PRIVATE LIMITED-PLOT
IDE+NAPHAZ 01% NO.3,TIVIM INDUSTRIAL
OLINE ESTATE KARASWADA
HYDROCHLOR MUPUSA-GOA 403 526
IDE+CHLORP INDIA
HRENIRAMIN
E
MALEATE+ME
NTHOL+CAM
PHOR
2118 NDA/MAL/H AVENTIS SURGIPHARM RIFINAH RIFAMPICIN + 300MG + AVENTIS PHARMA- SOUTH ORAL SOLID 1.0X20.0 7/1/2005
DP/4121 PHARMA (U) LIMITED 300 ISONIAZID 150MG AVENTIS PHARMA, 315 AFRICA ORDINARY TABLET
(PTY) LTD WALTLOO ROAD, TABLETS BLISTER
SOUTH SILVERTON 0127
AFRICA PRETORIA
2119 NDA/MAL/H MEDIPHARM MEDIPHARM PARACETA PARACETAM 120MG/5 MEDIPHARM INDUSTRIES UGANDA ORAL LIQUID 1.0X60.0 7/1/1997
DP/4125 SALES INDUSTRIES MOL OL ML (E.A) LTD-PLOT 65, ORDINARY ML
LIMITED (E.A) LTD SUSPENSIO KAKAJJO ROAD, SUSPENSION BOTTLE,1.
N BWEYOGERERE S 0X100.0
ML
BOTTLE
2120 NDA/MAL/H UNICHEM PHILLIPS UNICELIB CELECOXIB 100MG UNICHEM LABORATORIES INDIA ORAL SOLID 1.0X10.0X 7/1/2003
DP/4126 LABORATORIE PHARMACEUTIC 100 LTD-UNIT II, VILLAGE ORDINARY 10.0
S LTD ALS (UGANDA) BHATAULI KALAN, BADDI CAPSULES CAPSULE
LIMITED SOLAN (HP) 173205 BLISTER
2121 NDA/MAL/H SANOFI SURGIPHARM EPILIM SODIUM 200MG/5 UNITHER LIQUID FRANCE ORAL LIQUID 1.0X200.0 7/1/1998
DP/4127 AVENTS (U) LIMITED VALPROATE ML MANUFACTURING ORDINARY ML
FRANCE INDUSTRIE -COLOMIERS 1- SYRUPS BOTTLE,1.
3 ALLE DE LA NESTE L DEN 0X300.0
SIGAL 31770 ML
BOTTLE
2122 NDA/MAL/H RENE RENE VITAREN VITAMIN A + 1500IU/5M RENE INDUSTRIES LIMITED- UGANDA ORAL LIQUID 1.0X1.0X6 7/1/2008
DP/4128 INDUSTRIES INDUSTRIES SYRUP VITAMIN B2 + L+ PLOT 680 KAMULI- KIREKA ORDINARY 0.0 ML
LTD LIMITED VITAMIN B1 + 1MG/5ML SYRUPS BOTTLE,1.
VITAMIN B6 + + 0X1.0X100
VITAMIN C + 1MG/5ML .0 ML
VITAMIN E + + BOTTLE
VITAMIN B3 0.5MG/5M
L+
20MG/5ML
+ 100
IU/5ML +
10MG/5ML
2123 NDA/MAL/H WOCKHARDT STAR KEFSTAR- CEFUROXIME 250MG SANCE LABORATORIES INDIA ORAL SOLID 1.0X1.0X4 7/1/2005
DP/4130 LTD PHARMACEUTIC 250 AXETIL PVT. LTD.-VI/B, P.B. NO. 2, ORDINARY .0 TABLET
ALS LTD KOZHUVANAL, PALA, FILM- STRIP,1.0X
KOTTAYAM DISTRICT- COATED 10.0
686573, KERALA, TABLETS TABLET
INDIA. BLISTER
2124 NDA/MAL/H MYLAN KIMSY MEDS NEVIRAPIN NEVIRAPINE 200MG MYLAN LABORATORIES INDIA ORAL SOLID 1.0X60.0 7/1/2008
DP/4131 LABORATORIE LTD E LTD--F-4,F-12 MALEGAON ORDINARY TABLET
STATE
MYLAN LABORATORIES
LTD --H-12 & H-13, MIDC,
WALUJ,AURANGABAD-
431136 MAHARASHTRA,
INDIA
2125 NDA/MAL/H CADILA ABACUS ZYCEL 200 CELECOXIB 200MG CADILA HEALTHCARE INDIA ORAL SOLID 1.0X10.0X 7/1/2001
DP/4132 HEALTH CARE PHARMA LIMITED--KUNDAIM ORDINARY 10.0
LIMITED (AFRICA) INDUSTRIAL ESTATE, PLOT CAPSULES CAPSULE
LIMITED NO. 203-213, BLISTER
INDIA
2126 NDA/MAL/H INDOCO STAR CITAL DISODIUM 1.37G/5ML INDOCO REMEDIES LTD-B- INDIA ORAL LIQUID 1.0X100.0 7/1/2004
DP/4134 REMEDIES PHARMACEUTIC HYDROGEN 20, MIDC, WALUJ, ORDINARY ML
LTD ALS LTD CITRATE AURANGABAB 431136 SYRUPS BOTTLE
INDIA
2127 NDA/MAL/H SANOFI SURGIPHARM EPILIM 200 SODIUM 200MG FISONS LTD (ALSO SPAIN ORAL SOLID 1.0X10.0X 7/1/2001
DP/4141 WINTHROP (U) LIMITED VALPROATE KNOWN AS SANOFI- ORDINARY 10.0
A.M.O AVENTIS)-RIELL, SPAIN ENTERIC- TABLET
COATED BLISTER
TABLETS
2128 NDA/MAL/H DAFRA LABOREX CO- ARTEMETHER 360MG + MPF BV-APPLEHOF 13; NI NETHERLAND ORAL LIQUID 1.0X120.0 7/1/2010
DP/4142 PHARMA LTD UGANDA ARTESAINE + 2160MG 8465 RX OUDEHASKE S ORDINARY ML
LIMITED LUMEFANTRI NETHERLANDS DRY BOTTLE
NE SUSPENSION
S/SYRUPS/D
ROPS
2129 NDA/MAL/H MODI SURGIPHARM TAM TAMSULOSIN 0.4MG MODI MUNDIPHARMA INDIA ORAL SOLID 1.0X10.0X 7/1/2013
DP/4143 NUNDIPHAR (U) LIMITED CONTIN 0.4 HYDROCHLOR PVT. LTD-MEERUT- ORDINARY 10.0
MA PVT LTD IDE MUZAFFARNAGAR ROAD, TABLETS TABLET
MODIPURAM – 250110 STRIP
UTTAR PRADESH
2130 NDA/MAL/H GITTOES GITTOES AGOMPICL AMPICILLIN + 250 MG + MILAN LABORATORIES INDIA ORAL SOLID 1.0X10.0X 7/1/2011
DP/4146 PHARMACEUT PHARMACEUTIC OX CLOXACILLIN 250 MG (INDIA ) PVT LTD-PLOT ORDINARY 10.0
ICALS LIMITED ALS LIMITED NO.63-67 & 87,JAWAHAR CAPSULES CAPSULE
CO.OP.INDUSTRIAL BLISTER
ESTATE LTD
KAMOTHE,PANVEL DIST.
THANE,MAHARASTRA-
410209,INDIA
2131 NDA/MAL/H ERIS LTD BENLE CONSULT NIFEDI- NIFEDIPINE 20MG DENK PHARMA GMBH GERMANY ORAL SOLID 1.0X10.0X 7/1/2000
DP/4147 LIMITED DENK 20 &CO.KG- RETARD 10.0
RETARD PRINZREGENTESTR.79.816 FILM- TABLET
75 MUENCHEN, COATED STRIP
GERMANY, GOLLSTR, 1-D- TABLETS
845529
2132 NDA/MAL/H COSMOS ASTRA PHARMA AMITRIPTY AMITRIPTYLI 25MG COSMOS LTD.-RANGWE KENYA ORAL SOLID 10.0X10.0 7/1/1998
DP/4148 LIMITED (U) LIMITED LINE NE ROAD; OFF LUNGA LUNGA ORDINARY TABLET
TABLETS ROAD. P.O BOX 414 33, TABLETS BLISTER,1.
NAIROBI 0X100.0
TABLET
CONTAIN
ER,1.0X10
00.0
TABLET
CONTAIN
ER
2133 NDA/MAL/H BETA BETA TRACRIUM ATRACURIUM 10MG/ML GLAXO SMITHKLINE ITALY PARENTERAL 1.0X2.5 7/1/2010
DP/4149 HEALTHCARE HEALTHCARE INJECTION BESYLATE MANUFACTURING S.P.A .- ORDINARY ML
UGANDA UGANDA STARDA PROVINCIALE AMPOULES AMPOULE
LIMITED LIMITED ASOLANA 90, 43056 SAN ,1.0X5.0
POLO DI TORRILE (PARMA) ML
GLAXOSMITHKLINE SPA AMPOULE
FLEMING -2, 37135 ,1.0X10.0
PARMA ML
AMPOULE
2134 NDA/MAL/H TORRENT KARURI ANGIOPRIL- CAPTOPRIL 25MG TORRENT INDIA ORAL SOLID 10.0X10.0 7/1/1997
DP/4150 PHARMACEUT PHARMACEUTIC 25 PHARMACEUTICALS LTD- ORDINARY TABLET
ICALS LIMITED ALS LTD. INDRAD-382 721, TABLETS BLISTER
DIST.MEHSANA,INDIA.AT:
2135 NDA/MAL/H TATA TATA UGANDA DIAZEPAM DIAZEPAM 5MG/ML GLAND PHARMA LTD.- INDIA PARENTERAL 1.0X10.0X 7/1/2009
DP/4153 UGANDA LIMITED INJECTION GLAND PHARMA LTD, D.P. ORDINARY 2.0 ML
LIMITED PALLY, SURVEY NO. AMPOULES AMPOULE
143,150 &
2136 NDA/MAL/H CADILA ABACUS ZEFONE CEFTRIAXONE 1G SAKAR HEALTH CARE PVT, INDIA PARENTERAL 1.0X1.0 G 7/1/2001
DP/4165 HEALTHCARE PHARMA INJECTION SODIUM LTD-BLOCK NO. 10-13,M.N ORDINARY VIAL
LTD (AFRICA) DESAI PETROL DRY VIALS
LIMITED PUMP,SARKHEJ-BAVLA
ROAD,VILLAGE
CHANGODAR DIST
AHMEDABAD 382-
213,GUJARAT-INDIA
REYOUNG
PHARMACEUTICAL CO.
LTD-NO. 6 ERLANGSHAN
ROAD, YIYUAN,
2137 NDA/MAL/H CADILA ABACUS FLUCOZYD- FLUCONAZOL 200MG CADILA HEALTH CARE LTD- INDIA ORAL SOLID 1.0X4.0X7 7/1/2008
DP/4169 HEALTHCARE PHARMA 200 E SARKHEJ BAVLA N.H NO. ORDINARY .0
LTD (AFRICA) 8A MORAIJA, TAL, CAPSULES CAPSULE
LIMITED SANARD, AHMEDAD BLISTER,1.
382210, INDIA 0X5.0X4.0
CAPSULE
BLISTER
2138 NDA/MAL/H CADILA ABACUS TRAMAZAC TRAMADOL 50MG CADILA HEALTHCARE INDIA ORAL SOLID 1.0X10.0X 7/1/2000
DP/4170 HEALTH CARE PHARMA HYDROCHLOR LIMITED--KUNDAIM ORDINARY 10.0
LIMITED (AFRICA) IDE INDUSTRIAL ESTATE, PLOT CAPSULES CAPSULE
LIMITED NO. 203-213, BLISTER
INDIA
2139 NDA/MAL/H MACK SHURIK LTD TOREX MULTIINGRE N/A TORQUE INDIA ORAL SOLID 1.0X10.0X 7/1/2005
DP/4171 BROWN DIENT PHARMACEUTICALS LTD - ORDINARY 10.0
PHARMECEUT ISSAPUR P.O DAPPAR ENTERIC- TABLET
ICALS PVT LTD 140506 COATED BLISTER
TABLETS
2140 NDA/MAL/H RENE RENE KOF OFF MULTI- MULTI- RENE INDUSTRIES-PLOT UGANDA ORAL LIQUID 1.0X110.0 7/1/2005
DP/4172 INDUSTRIES INDUSTRIES EXPECTORA INGREDIENT INGREDIEN 680 KAMULI KIREKA ORDINARY ML
LIMITED NT T SYRUPS BOTTLE
2141 NDA/MAL/H AUROBINDO PHILLIPS KOACT AMOXYCILLIN 156.25MG/ AUROBINDO PHARMA INDIA ORAL LIQUID 1.0X100.0 7/1/2007
DP/4175 PHARMA LTD PHARMACEUTIC 156.25 TRIHYDRATE+ 5ML LTD, UNIT XII,.-SURVEY NO ORDINARY ML
ALS (UGANDA) POTASSIUM 314, BACHUPALLY DRY BOTTLE
LIMITED CLAVUNALAT VILLAGE, SUSPENSION
E QUTHUBULLAPAR, R.R S/SYRUPS/D
DISTRICT .A. PRADESH ROPS
2142 NDA/MAL/H CENTAUR GITTOES SINAREST- MULTI MULTI CENTAUR INDIA ORAL SOLID 1.0X10.0X 7/1/2007
DP/4182 PHARMACEUT PHARMACEUTIC FORTE INGREDIENT INGREDIEN PHARMACEUTICALS LTD- ORDINARY 10.0
ICALS LTD ALS LIMITED T PLOT NO.3 TIVIN TABLETS TABLET
INDUSTRIAL ESTATE BLISTER,1.
KARASWADA 403526 0X50.0X4.
INDIA 0 TABLET
STRIP
2143 NDA/MAL/H GITTOES GITTOES CHLORPRO CHLORPROM 25MG/ML NINGBO DAHONGYING CHINA PARENTERAL 1.0X10.0X 7/1/2011
DP/4183 PHARMACEUT PHARMACEUTIC MAZINE AZINE PHARMACEUTICAL CO LTD- ORDINARY 2.0 ML
ICALS LIMITED ALS LIMITED NO 396, MINGZHU ROAD AMPOULES AMPOULE
NINGBO CITY CHINA
2144 NDA/MAL/H BAYER SURGIPHARM NORIGYNO ESTRADIOL 5 MG+50 BAYER PHARMA A.G- GERMANY PARENTERAL 1.0X1.0 7/1/1997
DP/4187 PHARMA AG (U) LIMITED N VALERATE MG / ML MULLERSTRASSE 178, ORDINARY ML
+NORETHIND 13353 BERLIN, GERMANY AMPOULES AMPOULE
RONE
ENANTHATE
2145 NDA/MAL/H GITTOES GITTOES AGOPRAZ PRAZIQUANT 600MG AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1.0X10.0X 7/1/2013
DP/4188 PHARMACEUT PHARMACEUTIC EL NO.33,SECTOR ORDINARY 10.0
PADA,VASAI(E)DIST.THAN 0X2.0X4.0
E INDIA TABLET
BLISTER,1.
0X1.0X4.0
TABLET
BLISTER
2146 NDA/MAL/H GITTOES GITTOES AMPICILLIN AMPICILLIN 500MG CSPC ZHONGNUO CHINA PARENTERAL 1.0X10.0X 7/1/2011
DP/4241 PHARMACEUT PHARMACEUTIC SODIUM SODIUM PHARMACEUTICAL ORDINARY 500.0 MG
ICALS LIMITED ALS LIMITED FOR (SCIJIAZHUANG) CO. LTD DRY VIALS VIAL
INJECTION WORKSHOP -NO. 88
BP YANGZI ROAD,
SHIJIAZHUANG CITY,
LTD ALS LIMITED GIDC NEAR BAVLA DIST DRY VIALS 5 ML
AHMEDABAD 382220 NACL + 1
GUJARAT INDIA ML
SODIUM
BICARBO
NATE
2148 NDA/MAL/H NABIQASIM JEET VIVIRON FERRIC 50MG + NABIQASIM INDUSTRIES PAKISTAN ORAL LIQUID 1.0X90.0 7/1/2014
DP/4277 INDUSTRIES PHARMACEUTIC PLUS SYRUP AMMONIUM 0.5MG + (PVT) LTD-- ORDINARY ML
(PVT) LIMITED ALS LIMITED CITRATE 2.2MG + 17/24,KORANGI SYRUPS BOTTLE,1.
+FOLIC ACID + 1.3MG INDUSTRIAL AREA, 0X250.0
PYRIDOXINE +11MG KORANGI, KARACHI- ML
HCL + PAKISTAN. BOTTLE
THIAMINE
HCL +
NICOTINAMI
DE
2149 NDA/MAL/H AUROLAB SWASTIK AUROTIM TIMOLOL 0.5% W/V AUROLAB-NO. 1, INDIA OPHTHALMI 1.0X5.0 7/1/2016
DP/4279 PHARMACEUTIC MALEATE SIVAGANGAI MAIN ROAD, C DROPS ML
AL LTD VEERAPANJAN, MADURAI BOTTLE
2150 NDA/MAL/H MYLAN KIMSY MEDS ABACAVIR ABACAVIR 600 MG + MYLAN LABORATORIES INDIA ORAL SOLID 1.0X30.0 7/1/2013
DP/4280 LABORATORIE LTD SULFATE+L SULFATE + 300 MG LTD ,-PLOT NO. 11, 12, & ORDINARY TABLET
S LIMITED AMIVUDINE LAMIVUDINE 13 INDORE SPECIAL TABLETS CONTAIN
ECONOMIC ZONE, ER
PHARMA ZONE, PHASE II,
SECTOR III PITHAMPUR
454775, DIST DHAR –
MADHYA PRADESH
MYLAN LABORATORIES
LTD--F-4,F-12 MALEGAON
MIDC SINNAR NASHIK
422113 MAHARASHTRA
2151 NDA/MAL/H SANCE DELMAW SANAXONE CEFTRIAXONE 1000MG SANCE LABORATORIES INDIA PARENTERAL 1.0X10.0 7/1/2010
DP/4287 LABORATORIE ENTERPRISES 1000 PVT. LTD.-VI/B, P.B. NO. 2, ORDINARY ML
S PVT LTD LIMITED KOZHUVANAL, PALA, DRY VIALS VIAL,1.0X
KOTTAYAM DISTRICT- 50.0X10.0
686573, KERALA, ML VIAL
INDIA.
2152 NDA/MAL/H GLAXOSMITH UNITED TWINRIX INACTIVATED 720 ELISA GLAXOSMITHKLINE BELGIUM PARENTERAL 1.0X1.0 7/1/2013
DP/4289 KLINE LTD HEALTHCARE ADULT HEPATITIS A UNITS + BOILOGICALS-S.A RUE DE ORDINARY ML VIAL
DISTRIBUTORS ANTIGEN + 20MCG I'INSTITUT 89 B-1330 VIALS (1 DOSE)
LTD HEPATITIS B RIXENSART
SURFACE
ANTIGEN
2153 NDA/MAL/H GITTOES GITTOES VITAMIN B VITAMIN B 10MG/2ML NINGBO DAHONGYING CHINA PARENTERAL 1.0X10.0X 7/1/2008
DP/4291 PHARMACEUT PHARMACEUTIC COMPLEX COMPLEX PHARMACEUTICALS LTD- ORDINARY 2.0 ML
ICALS LIMITED ALS LIMITED INJECTION NO. 396 MIN AMPOULES AMPOULE
2154 NDA/MAL/H F. HOFFMANN LABOREX HERCEPTIN TRASTUZUMA 150MG ROCHE DIAGNOSTICS SWITZERLAN PARENTERAL 1.0X1.0 7/1/2016
DP/4292 LA-ROCHE UGANDA 150MG B GMBH MANNHEIM-- D ORDINARY VIAL
LIMITED SANDHOFER STRASSE 116 - DRY VIALS CARTON
68305 MANNHEIM
GERMANY.
2155 NDA/MAL/H ASTRA LIFE ASTRA PHARMA ASTRAFLA PARACETAM 500MG + ASTRA LIFE CARE (INDIA) INDIA ORAL SOLID 1.0X10.0X 7/1/2016
DP/4295 CARE (INDIA) (U) LIMITED M TABLETS OL + 400MG PVT.LTD-PLOT NO. 57/P, ORDINARY 10.0
PVT LTD IBUPROFEN SARKHEJ-BAVLA TABLETS TABLET
AHMEDABAD INDIA
2156 NDA/MAL/H INDOCO STAR CLOBEN-G CLOTRIMAZO 1%W/W+0. INDOCO REMEDIES INDIA TOPICAL 1.0X15.0 7/1/2009
DP/4297 REMEDIES PHARMACEUTIC LE/BECLOME 025%W/W LIMITED-L-14 VERNA EXTERNAL G TUBE
LIMITED ALS LTD THASONE/GE +0.1%W/W INDUSTRIAL AREA VERNA CREAMS
NTAMYCIN
2157 NDA/MAL/H PFIZER LABOREX SAYANA MEDROXYPR 104MG/0.6 PFIZER MANUFACTURING - BELGIUM PARENTERAL 1.0X200.0 7/1/2010
DP/4303 LABORATORIE UGANDA PRESS OGESTERONE 5ML NV/NA, RIJKSWEG 12 ORDINARY I X0.65 ML
S (PTY) LIMITED ACETATE 2870, PUURS M PRE- PRE-
FILLED FILLED
SYRINGES SYRINGE
2158 NDA/MAL/H ARISTO NORVIK MIKACIN AMIKACIN 500MG/2 ARISTO INDIA PARENTERAL 1.0X5.0X8 7/1/2009
DP/4307 PHARMACEUT ENTERPRISES SULPHATE ML PHARMACEUTICALS PVT. ORDINARY .0X2.0 ML
ICALS PVT LTD LIMITED LIMITED-PLOT NO. 208, VIALS VIAL,1.0X
NEW INDUSTRIAL AREA 1.0X2.0
NO.II,MANDIDEEEP ML VIAL
PRADESH
2159 NDA/MAL/H HETERO AIVEEN (U) LAMIVUDIN LAMIVUDINE 150MG + HETERO LABS LTD (UNIT- INDIA ORAL SOLID 1.0X60.0 7/1/2010
DP/4309 DRUGS LTD LIMITED E+ + 300MG V)-SY.NO.438,439,440 & ORDINARY TABLET
ZIDOVUDIN ZIDOVUDINE 458 APIIC FORMULATION FILM- BOTTLE
E SEZ, POLEPALLY (V), COATED
JEDCHERLA (M) TABLETS
MAHABOOBNAGAR
DISTRICT, ANDHRA
LABS LTD-22-110 IDA
500-055 ANDHRA
PRADESH
2160 NDA/MAL/H MERCK (PTY) UNITED GONAL-F FOLLITROPIN 75IU/IE MERCK SERONO S.P.A-VIA SWITZERLAN PARENTERAL 1.0X1.0 7/1/2016
DP/4312 LTD HEALTHCARE ALFA DELLE D ORDINARY VIAL
DISTRIBUTORS MAGNOLIE,15.70026 DRY VIALS CARTON +
LTD MODUGNO (BA).ITALY 1 PRE
MERCK SERONO S.A. FILLED
(MSA) -1170 SUCCURSALE SYRINGE
D’AUBONNE ZONE OF WFI
INDUSTRIELLE DE
L’OURIETTAZ,
SWITZERLAND
2161 NDA/MAL/H DENK BENLE CONSULT DESLORA- DESLORATIDI 5MG DENK PHARMA GMBH & GERMANY ORAL SOLID 1.0X10.0 7/1/2016
DP/4315 PHARMA LIMITED DENK 5 NE CO.KG -GOLLSTR 1,84529 ORDINARY TABLET
GMB H &CO. TITTMONING GERMANY FILM- BLISTER
KG COATED
TABLETS
2162 NDA/MAL/H DENK BENLE CONSULT COLOSAR- LOSARTAN + 50MG + DENK PHARMA GMBH GERMANY ORAL SOLID 1.0X1.0X1 7/1/2011
DP/4317 PHARMA LIMITED DENK HYDROCHLOR 12.5MG &CO.KG-- ORDINARY 4.0
GMB H &CO. 50/12.5 OTHIAZIDE PRINZREGENTESTR.79.816 TABLETS TABLET
KG 75 MUENCHEN, BLISTER,1.
GERMANY, GOLLSTR, 1-D- 0X2.0X14.
GERMANY BLISTER
2163 NDA/MAL/H UNOSOURCE ESCORTS AKUGABALI PREGABALIN 75 MG AKUMS DRUGS & INDIA ORAL SOLID 1.0X3.0X1 1/7/2016
DP/4318 PHARMA LTD. PHARMACEUTIC N PHARMACEUTICALS LTD- ORDINARY 0.0
ALS LIMITED 19, 20,21 SECTOR 6A IIE CAPSULES CAPSULE
SIDCUL RANIPUR BLISTER
HARIDWAR 249 403
2164 NDA/MAL/H NORVATIS LABOREX CUSIMOLOL TIMOLOL 0.5% W/V ALCON CUSI S.A .-CAMIL SPAIN OPHTHALMI 1.0X5.0 7/1/2000
DP/4321 PHARMA AG- UGANDA 0.5% MALEATE FABRA,58 08320 EL C DROPS ML VIAL
SWITZERLAN LIMITED MASNOU BARCELONA
D SPAIN
2165 NDA/MAL/H MSN ABACUS PRASUSAFE PRASUGREL 5MG MSN LABORATORIES LTD- INDIA ORAL SOLID 1.0X3.0X1 7/1/2013
DP/4324 LABORATORIE PHARMA 5 PLOT 42 ANRICH ORDINARY 0.0
PRADESH
2166 NDA/MAL/H AJANTA ABACUS ACTINAC ACECLOFENA 100MG AJANTA PHARMA LIMITED- INDIA ORAL SOLID 1.0X10.0X 7/1/2009
DP/4325 PHARMA LTD PHARMA 100 C B-4-5-6, MIDC AREA ORDINARY 2.0X10.0
31-0 (AFRICA) PAITHAN, AURANGABAD, FILM- TABLET
LIMITED 431148 COATED BLISTER
DIST:AURANGABAD TABLETS
MAHARASHTRA, INDIA.
2167 NDA/MAL/H NORVATIS LABOREX CUSICROM SODIUM 4 %W/V ALCON CUSI S.A .-CAMIL SPAIN OPHTHALMI 1.0X10.0 7/1/2002
DP/4326 PHARMA AG- UGANDA 4% EYE CROMOGLYC FABRA,58 08320 EL C DROPS ML VIAL
SWITZERLAN LIMITED DROPS ATE MASNOU BARCELONA
D SPAIN
2168 NDA/MAL/H GITTOES GITTOES AGO-CPM CHLORPHENI 2MG/5ML AGOG PHARMA LTD-PLOT INDIA ORAL LIQUID 1.0X1.0X1 7/1/2010
DP/4329 PHARMACEUT PHARMACEUTIC RAMINE NO.33,SECTOR ORDINARY 00.0 ML
ICALS LIMITED ALS LIMITED MALEATE II,VASAI,TALUKA INDL CO- SYRUPS BOTTLE,1.
OP ESTATE LTD,GAURAI 0X1.0X60.
PADA,VASAI(E)DIST.THAN 0 ML
E INDIA BOTTLE
2169 NDA/MAL/H SPARSH BIO- ABACUS FLUCLOXAC FLUCLOXACIL 250MG SPARSH BIO-TECH PVT. INDIA ORAL SOLID 1.0X10.0 7/1/2016
DP/4330 TECH PVT. PHARMA ILLIN LIN LTD.--PLOT NO. 1, SURVEY ORDINARY CAPSULE
LTD (AFRICA) CAPSULES NO. 242/243/244, VILLAGE CAPSULES STRIP
LIMITED LAKHABAVAD POST
KHODIYAR COLONY
2170 NDA/MAL/H STEDMAN VEERAM STEDNAC ACECLOFENA 100MG STEDMAN INDIA ORAL SOLID 1.0X1.0X1 7/1/2010
DP/4331 PHARMACEUT HEALTHCARE C PHARMACEUTICALS PVT ORDINARY 0.0
ICALS PVT. (U) LIMITED LIMITED-NO. C-4, SIDCO FILM- TABLET
LTD PHARMACEUTICAL COATED BLISTER,1.
COMPLEX, ALATHUR, TABLETS 0X10.0X10
THIRUPORUR, .0 TABLET
KANCHEEPURAM DIST 603 BLISTER
2171 NDA/MAL/H ZEE ZEE CARVIBERG CARVEDILOL 6.25MG THE MADRAS INDIA ORAL SOLID 1.0X3.0X1 7/1/2016
DP/4333 PHARMACEUT PHARMACEUTIC USP PHARMACEUTICALS-137- ORDINARY 0.0
ICALS LTD ALS LIMITED B,OLD MAHABALI PURAM FILM- TABLET
ROAD,KARAPAKKAM,CHEN COATED BLISTER
NAL INDIA TABLETS
2172 NDA/MAL/H DENK PHARM BENLE CONSULT LOSAR- LOSARTAN 50MG DENK PHARMA GMBH & GERMANY ORAL SOLID 1.0X2.0X1 7/1/2011
DP/4334 GMBH&CO.K LIMITED DENK 50 CO.-PRINZREGENTENSTR. ORDINARY 4.0
G 79, 81675 MÜNCHEN, FILM- TABLET
GÖLLSTR. 1, 84529 COATED BLISTER
TITTMONING, GERMANY TABLETS
2173 NDA/MAL/H DAWA SUPER MEDIC CURAMOL PARACETAM 120MG/5 DAWA LTD-BABA DOGO KENYA ORAL LIQUID 1.0X100.0 7/1/2009
DP/4335 LIMITED LTD SUSPENSIO OL ML ROAD RUARAKA ORDINARY ML
N SUSPENSION BOTTLE,1.
S 0X60.0 ML
BOTTLE
2174 NDA/MAL/H MISSION JOINT MEDICAL ALBENDAZ ALBENDAZOL 400MG MEDICAMEN BIOTECH LTD- INDIA ORAL SOLID 1.0X500.0 7/1/2008
DP/4338 PHARMA STORE (UPMB - OLE E SP-1192, A &B, PHASE –IV, ORDINARY TABLET
UCMB) INDUSTRIAL AREA TABLETS CONTAIN
BHIWADI -301019 DIST. ER
ALWAR (RAJASTHAN)
2175 NDA/MAL/H GLAXOSMITH UNITED SERETIDE SALMETEROL 25MCG/12 GLAXO WELLCOME FRANCE LUNG 1.0X120.0 7/1/2007
DP/4339 KLINE HEALTHCARE 125 XINAFOATE + 5MCG PRODUCTION-ZONE ADMINISTRA METERED
LIMITED DISTRIBUTORS EVOHALER FLUTICASONE INDUSTRIELLE NO.2 TION CFC- DOSE
LTD PROPIONATE 23 RUE LAVOISER 27000 FREE CANNISTE
EVREUX METERED- R
DOSE
INHALER
2176 NDA/MAL/H PASTEUR LABOREX EUVAX B HEPATITIS B 20MCG/ML LG LIFE SCIENCES LTD- SOUTH PARENTERAL 1.0X0.5 7/1/2007
DP/4343 MERIEUX UGANDA (PAEDIATRI VACCINE, 601, YONGJEI-DONG, KOREA ORDINARY I ML VIAL
CONNANGHT LIMITED C) RECOMBINAN IKSAN, JE M VIALS (1 DOSE)
T
2177 NDA/MAL/H TORRENT KARURI LISTRIL-10 LISINOPRIL 10MG TORRENT INDIA ORAL SOLID 1.0X10.0X 7/1/2000
DP/4344 PHARMACEUT PHARMACEUTIC PHARMACEUTICAL LTD- ORDINARY 10.0
ICALS LTD ALS LTD. AHMEDABAD-MEHSANA TABLETS TABLET
AD-382721
2178 NDA/MAL/H GENO HARLEYS VERTIGON CINNARIZINE 25MG GENO PHARMACEUTICALS INDIA ORAL SOLID 1.0X4.0X5 7/1/2010
DP/4347 PHARMACEUT UGANDA LTD. -TIVIM INDUSTRIAL ORDINARY .0X10.0
ICALS PVT LTD LIMITED ESTATE, KARASWADA, TABLETS TABLET
MAPUSA, GOA BLISTER
2179 NDA/MAL/H REGAL REGAL PHARMA MEDICLOA CLOXACILLIN+ 250MG/5 REGAL KENYA ORAL LIQUID 1.0X100.0 7/1/1997
DP/4348 PHARMACEUT (U) LTD MP SYRUP AMPICILLIN ML PHARMACEUTICALS LTD- ORDINARY ML
ICALS LTD BABA DOGO ROAD, DRY BOTTLE
S/SYRUPS/D
ROPS
2180 NDA/MAL/H ACINO GOODMAN OLFEN-75 DICLOFENAC 75MG/2ML MERCKLE GMBH,-LUDWIG GERMANY PARENTERAL 1.0X5.0X2 7/1/1997
DP/4350 PHARMA AG INTERNATIONAL SODIUM MERCKLE STRASSE3 D- ORDINARY .0 ML
LTD 89143 BLAUBEUREN AMPOULES AMPOULE
HAUPT PHARMA WULFING
GMBH.-BETHELNER
LANDSTR. 18, 31028
GRONAU/LEINE
2181 NDA/MAL/H CIPLA LTD QUALITY ABACAVIR ABACAVIR 60MG CIPLA LTD-PATALGANGA INDIA ORAL SOLID 1.0X60.0 7/1/2010
DP/4351 CHEMICALS LTD - SULFATE SULPHATE UNIT II PLOT MO A-33 A42 ORDINARY TABLET
HUMAN MIDC RAIGAD TABLETS BOTTLE
2182 NDA/MAL/H RENE RENE REQUIN QUININE 100MG/5 RENE INDUSTRIES LTD- UGANDA ORAL LIQUID 1.0X100.0 7/1/2001
DP/4352 INDUSTRIES INDUSTRIES SYRUP HYDROCHLOR ML PLOT 680, KAMULI ROAD, ORDINARY ML
LTD LIMITED IDE KIREKA, P.O BOX 6034, SYRUPS BOTTLE
KAMPALA
2183 NDA/MAL/H ADCOCK UGANDA FRESHEN BISACODYL 5 MG ADCOCK INGRAM LIMITED INDIA ORAL SOLID 1.0X12.0 7/1/2016
DP/4356 INGRAM HEALTH -49C & D BOMMASANDRA ORDINARY TABLET
LIMITED MARKETING INDUSTRIAL AREA ANEKAL FILM- BLISTER
GROUP LIMITED TALUK, BANGALORE COATED
TABLETS
560099, KARNATAKA
STATE, INDIA
2184 NDA/MAL/H A.MENARINI PHILLIPS LIOTON HEPARIN 1000I.U/G A. MENARINI ITALY TOPICAL 1.0X30.0 7/1/2016
DP/4358 INDUSTRIE PHARMACEUTIC SODIUM MANUFACTURING EXTERNAL G
FARMACEUTI ALS (UGANDA) LOGICTICS AND SERVICES- GELS AND TUBE,1.0X
CHE S.R.I LIMITED VIA 3 SETTE SANTI SOLS 15.0 G
FLORENCE 50131 ITALY TUBE
2185 NDA/MAL/H ASTRAZENEC MACNAUGHTON ZESTRIL LISINOPRIL 5MG ASTRAZENECA UNITED ORAL SOLID 1.0X14.0 7/1/1997
DP/4360 A LIMITED PHARMACEUTICALS LP - KINGDOM ORDINARY TABLET
HUANGSHAN ROAD, WUXI TABLETS BLISTER,1.
214028, JIANGSU, CHINA. 0X2.0X14.
ASTRAZENECA 0 TABLET
MACCLESFIELD-UNITED BLISTER
KINGDOM
2186 NDA/MAL/H MACLEODS NORVIK LEVOMAC LEVOFLOXACI 750MG MACLEODS INDIA ORAL SOLID 1.0X1.0X1 7/1/2016
DP/4362 PHARMACEUT ENTERPRISES 750 N PHARMACEUTICALS ORDINARY 0.0
ICAL LTD LIMITED HEMIHYDRAT LIMITED -BLOCK-N2 FILM- TABLET
E VILLAGE THEDA POST COATED BLISTER,1.
OFFICE LODHIMAJRA TABLETS 0X10.0X10
TEHSIL BADDI DISTRICT .0 TABLET
SOLAN HIMACHAL BLISTER
PRADESH – 174101
INDIA
2187 NDA/MAL/H CADILA ABACUS VOMIZ OD ONDANSETR 8MG CADILA HEALTHCARE INDIA ORAL SOLID 1.0X10.0X 7/1/2016
DP/4364 HEALTHCARE PHARMA 8 ON LIMITED--KUNDAIM ORDINARY 10.0
LIMITED (AFRICA) HYDROCHLOR INDUSTRIAL ESTATE, PLOT TABLETS TABLET
LIMITED IDE NO. 203-213, BLISTER
DIHYDRATE KUNDAIM,GOA-403 115,
INDIA
2188 NDA/MAL/H AJANTA ABACUS ACTINAC ACECLOFENA 100 MG + AJANTA PHARMA LIMITED- INDIA ORAL SOLID 1.0X2.0X1 7/1/2009
DP/4365 PHARMA LTD PHARMA PLUS C+ 500 MG B-4/5/6,MIDC AREA, ORDINARY 0.0
(AFRICA) PARACETAM PAITHAN,431 148 INDIA. FILM- TABLET
LIMITED OL COATED BLISTER
TABLETS
2189 NDA/MAL/H SPARSH BIO- ABACUS CLOXISPA CLOXACILLIN 250MG SPARSH BIO-TECH LTD- INDIA ORAL SOLID 1.0X10.0X 7/1/2004
DP/4366 TECH PVT LTD PHARMA PLOT NO.1 SURVEY ORDINARY 10.0
(AFRICA) NO.242/234/244, VILLAGE CAPSULES CAPSULE
361006 0X1000.0
CAPSULE
CONTAIN
ER,1.0X10
0.0X10.0
CAPSULE
BLISTER
2190 NDA/MAL/H ASTRA MACNAUGHTON ATACAND CANDESARTA 8MG ASTRA ZENECA AB, SWEDEN ORAL SOLID 1.0X2.0X1 7/1/2010
DP/4367 ZENECA LIMITED 8MG N SODERTALJE- ORDINARY 4.0
GARTUNAYEGEN, TABLETS TABLET
SODERTALJE BLISTER
2191 NDA/MAL/H CIPLA LTD. QUALITY LAMIVUDIN LAMIVUDINE 150MG + CIPLA LTD-VERNA INDIA INDIA ORAL SOLID 1.0X60.0 7/1/2007
DP/4368 CHEMICALS LTD - E, + 300MG + ESTATES 403722 GOA ORDINARY TABLET
HUMAN NEVIRAPIN ZIDOVUDINE 200MG INDA TABLETS CONTAIN
E AND + ER
ZIDOVUDIN NEVIRAPINE
E
2192 NDA/MAL/H KAMPALA KAMPALA FLUCAP CHLORPHENA 1.25MG+1 TIL HEALTH CARE-PLOT INDIA ORAL LIQUID 1.0X100.0 7/1/1997
DP/4369 PHARMACEUT PHARMACEUTIC MINE 0MG+120 100,WEST,R- ORDINARY ML
ICAL AL INDUSTRIES MALEATE+PS MG 5,SOUTH;SRICITY SYRUPS BOTTLE
INDUSTRIES 1996 LIMITED EUDOEPHEDR SEZ,CHERIVI,IRUHULAM,PS
(1996) LTD INE OT,SATYAVEDU
HYDROCHLOR MANDAL,CHITOOR
IDE+PARACET DISTRICT-ANDRA
AMOL PRADESH-517588, INDIA
2193 NDA/MAL/H ZEE ZEE AZIBERG AZITHROMYCI 500MG THE MADRAS INDIA ORAL SOLID 1.0X3.0 7/1/2016
DP/4373 PHARMACEUT PHARMACEUTIC N DIHYDRATE PHARMACEUTICALS-137- ORDINARY TABLET
ICALS LTD ALS LIMITED B,OLD MAHABALI PURAM FILM- BLISTER
ROAD,KARAPAKKAM,CHEN COATED
NAL INDIA TABLETS
2194 NDA/MAL/H CIPLA LTD. QUALITY EFAVIRENZ EFAVIRENZ + 600MG CIPLA LTD -MIDC INDIA ORAL SOLID 1.0X30.0 7/1/2016
DP/4376 CHEMICALS LTD - +LAMIVUDI LAMIVUDINE +300MG + PATALGANGA MS 410 220 ORDINARY TABLET
HUMAN NE & + TENOFOVIR 300MG INDIA MFG LIC: 845 FILM- CONTAIN
TENOFOVIR COATED ER
TABLETS TABLETS
2195 NDA/MAL/H MEDIPHARM MEDIPHARM ORALYTE ANHYDROUS 13.5MG + MEDIPHARM INDUSTRIES UGANDA ORAL LIQUID 1.0X20.5 7/1/2008
DP/4377 SALES INDUSTRIES GLUCOSE + 2.6MG + (E.A) LTD-PLOT 65, ORDINARY G
LIMITED (E.A) LTD SODIUM 2.9MG + KAKAJJO ROAD, SOLUBLE SACHET,1.
CHLORIDE + 1.5MG BWEYOGERERE POWDERS 0X10.25 G
TRISODIUM SACHET
CITRATE
DIHYDRATE +
POTASSIUM
CHLORIDE
2196 NDA/MAL/H LEBEN ANDYCO SINURHON MULTI- 5MG/ LEBEN LABORATORIES INDIA ORAL SOLID 1.0X12.0X 7/1/2010
DP/4379 LABORATORIE PHARMACY INGREDIENT 2MG/ PVT. LTD-PLOT NO. L-4, ORDINARY 40.0
S PVT.LTD (UGANDA) LTD 500MG / PHASE-III, MIDC, TABLETS TABLET
30MG AKOLA– 444 104 (MS). BLISTER,1.
0X1.0X6.0
X20.0
TABLET
BLISTER,1.
0X500.0
TABLET
CONTAIN
ER
2197 NDA/MAL/H GLAXO UNITED ZINNAT CEFUROXIME 125MG/5 GLAXOSMITHKLINE UK UNITED ORAL LIQUID 1.0X100.0 7/1/1998
DP/4380 WELLCOME HEALTHCARE SUSPENSIO AXETIL- ML LTD-HARMIRE RD KINGDOM ORDINARY ML
(KENYA) LTD DISTRIBUTORS N BARNARD CASTLE DRY BOTTLE,1.
LTD DURHAM, DL12DT UNITED SUSPENSION 0X50.0 ML
S/SYRUPS/D BOTTLE
ROPS
2198 NDA/MAL/H LINCOLN METRO DICLOFENAC 50MG LINCOLN INDIA ORAL SOLID 10.0X10.0 7/1/2016
DP/4381 PHARMACEUT PHARMACEUTIC DICLOFENA SODIUM PHARMACEUTICALS LTD- ORDINARY TABLET
ICALS LTD ALS LIMITED C SODIUM 10, 11, 13, TRIMUL ESTATE ENTERIC- BLISTER
KHATRAJ, NEAR COATED
KHATRAJ, CHOKADI , TABLETS
KHATRAJ-382721,
GHANDINAGARGUJARAT,
INDIA
2199 NDA/MAL/H ZEE ZEE ZEEMYCIN - CLINDAMYCI 150MG THE MADRAS INDIA ORAL SOLID 1.0X10.0X 7/1/2016
DP/4383 PHARMACEUT PHARMACEUTIC 150 N PHARMACEUTICALS-137- ORDINARY 10.0
ICALS LTD ALS LIMITED HYDROCHLOR B,OLD MAHABALI PURAM OTHER CAPSULE
IDE BP ROAD,KARAPAKKAM,CHEN CAPSULES BLISTER
NAL INDIA
2200 NDA/MAL/H SWISS SHREEJI TAZOBAK PIPERACILLIN 4.0G + SWISS PARENTERALS LTD- INDIA PARENTERAL 1.0X4.5 G 7/1/2016
DP/4388 PARENTERALS PHARMACEUTIC SODIUM + 0.5G 809 KERALA IND ESTATE ORDINARY VIAL
LTD ALS LIMITED TAZOBACTAM GIDC NEAR BAVLA DIST DRY VIALS
SODIUM AHMEDABAD 382220
GUJARAT INDIA
2201 NDA/MAL/H PHARMACARE MEDICAL PREZISTA DARUNAVIR 600MG JANSSEN ORTHO LLC.-- UNITED ORAL SOLID 1.0X60.0 7/1/2011
DP/4389 LTD ACCESS STATE ROAD 933 KM 0.1 STATES ORDINARY TABLET
(UGANDA) MARNEY WARD GURABO TABLETS CONTAIN
LIMITED PUERTO RICO 00778 ER
2202 NDA/MAL/H AUROLAB SWASTIK AUROCOL CHLORAMPH 0.5%W/V AUROLAB-NO 1 INDIA OPHTHALMI 1.0X10.0 7/1/2016
DP/4390 PHARMACEUTIC ENICOL SIVAGANGAI MAIN ROAD, C DROPS ML
AL LTD VEERAPANJAN MADURAI BOTTLE
– 625 020 TAMIL NADU,
INDIA
2203 NDA/MAL/H LINCOLN METRO MOBYLE-A ACECLOFENA 100 MG + LINCOLN INDIA ORAL SOLID 1.0X10.0X 7/1/2016
DP/4391 PHARMACEUT PHARMACEUTIC C+ 325 MG PHARMACEUTICALS LTD- ORDINARY 10.0
ICALS LTD ALS LIMITED PARACETAM TRIMUL ESTATE AT & FILM- TABLET
OL POST KHATRAJ TAL KALOL COATED BLISTER
DIST GANDHINAGAR TABLETS
GUJARAT
2204 NDA/MAL/H IND SWIFT PLANET CAPLOR CLOPIDOGREL 75MG IND SWIFT LTD-GBU INDIA ORAL SOLID 1.0X3.0X1 7/1/2003
DP/4392 LTD PHARMACEUTIC JAWAHARPUR OFF NH-21 ORDINARY 0.0
ALS UGANDA DERABASSI DIST MOHALI TABLETS TABLET
LTD BLISTER
2205 NDA/MAL/H ABACUS ABACUS NS SODIUM 0.9% W/V ABACUS PARENTERAL UGANDA PARENTERAL 1.0X500.0 7/1/2010
DP/4394 PARENTERAL PARENTERAL CHLORIDE DRUGS LTD-PLOT NO. 114, ORDINARY ML
DRUGS DRUGS LIMITED BLOCK 191, GWAGAMYA, INFUSION BOTTLE,1.
LIMITED KINGA, KAPEKE, VIALS/BOTTL 0X250.0
MUKONO ES ML
BOTTLE
2206 NDA/MAL/H MYLAN KIMSY MEDS ABACAVIR ABACAVIR 300MG MYLAN LABORATORIES INDIA ORAL SOLID 1.0X60.0 7/1/2007
DP/4396 LABORATORIE LTD SULPHATE SULFATE LTD--F-4,F-12 MALEGAON ORDINARY TABLET
S LIMITED MIDC SINNAR NASHIK FILM- BOTTLE
(OTL) 422113 MAHARASHTRA COATED
STATE TABLETS
MYLAN LABORATORIES
LTD-PLOT NO.11, 12 & 13,
INDORE SPECIAL
ECONOMIC ZONE,
SECTOR III, PITHAMPUR -
454775; DIST; DHAR;
2207 NDA/MAL/H NIRMA LIFE PHARMA SODIUM SODIUM 0.9 % W/V ACULIFE HEALTHCARE INDIA PARENTERAL 1.0X500.0 7/1/1997
DP/4398 LIMITED AFRICA LIMITED CHLORIDE CHLORIDE PVT. LTD-VILLAGE ORDINARY ML
(HEALTHCARE SACHANA ,TALUKA - INFUSION BOTTLE,1.
DI VISION) VIRAMGAM , VIALS/BOTTL 0X250.0
NIRLIFE AHMEDABAD 382150 ES ML
HEALTHCARE GUJARAT BOTTLE
2208 NDA/MAL/H COSMOS LTD ASTRA PHARMA ORAL ORAL N/A COSMOS LIMITED-- KENYA ORAL LIQUID 1.0X100.0 7/1/1997
DP/4400 (U) LIMITED REHYDRATI REHYDRATIO RANGWA ROAD, OFF ORDINARY X20.6 G
ON SALT N SALT LUNGA LUNGA ROAD,P.O SOLUBLE SACHET,1.
(DTS) BOX 414 33, NAIORBI POWDERS 0X100.0X1
INDUSTRIAL AREA 0.3 G
SACHET
2209 NDA/MAL/H EGYPTIAN WIDE EPICEPHIN CEFTRIAXONE 2G EGYPTIAN EGYPT PARENTERAL 1.0X2.0 G 7/1/2014
DP/4401 INTERNATION SPECTRUM DISODIUM INTERNATIONAL ORDINARY VIAL +
AL ENTERPRISES PHARMACEUTICAL DRY VIALS 2*5 ML
PHARMACEUT (U) LIMITED INDUSTRIES COMPANY- OF WFI
ICAL 10TH OF RAMADAN CITY GLASS
INDUSTRIES FIRST INDUSTRIAL AREA AMPOULE
COMPANY S
2210 NDA/MAL/H VIRBAC RSA METRO CLOTRILIN CLOTRIMAZO 100MG LINCOLN INDIA VAGINAL 1.0X6.0 7/1/2014
DP/4402 (PTY) LTD PHARMACEUTIC LE PHARMACEUTICALS LTD- TABLETS TABLET
ALS LIMITED 10, 11, 13, TRIMUL ESTATE STRIP
KHATRAJ, NEAR
KHATRAJ, CHOKADI ,
KHATRAJ-382721,
GHANDINAGARGUJARAT,
INDIA
2211 NDA/MAL/H BHARAT ABACUS FOLIGRAF RECOMBINAN 75I.U/ VIAL BHARAT SERUMS AND INDIA PARENTERAL 1.0X1.0 7/1/2016
DP/4404 SERUMS AND PHARMA T HUMAN VACCINES LIMITED,-PLOT ORDINARY VIAL
VACCINES LTD (AFRICA) FOLLICLE NO. K-27, ADDITIONAL DRY VIALS CARTON
LIMITED STIMULATING MIDC,
HORMONE AMBERNATH (EAST),
INDIA
2212 NDA/MAL/H GITTOES GITTOES SATISFIL - SILDENAFIL 100MG AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1.0X4.0 7/1/2011
DP/4406 PHARMACEUT PHARMACEUTIC 100 NO.33,SECTOR ORDINARY TABLET
E INDIA
2213 NDA/MAL/H REGAL REGAL PHARMA UNISTEN CLOTRIMAZO 1%W/W REGAL KENYA TOPICAL 1.0X20.0 7/1/1997
DP/4408 PHARMACEUI (U) LTD CREAM LE PHARMACEUTICALS LTD- EXTERNAL G TUBE
CALS LTD BABA DOGO ROAD, CREAMS
2214 NDA/MAL/H AUROBINDO PHILLIPS M-KAST 4 MONTELUKAS 4MG AUROBINDO PHARMA LTD INDIA ORAL SOLID 1.0X3.0X1 7/1/2016
DP/4410 PHARMA PHARMACEUTIC T CHEWABLE UNIT VII (SEZ) APIIC-PLOT ORDINARY 0.0
LIMITED ALS (UGANDA) TABLETS 4 NO. S1 SURVEY NO. CHEWABLE TABLET
LIMITED MG 411,425,434,435 & 458 TABLETS BLISTER
GREEN INDUSTRIAL PARK
POLEPALLY VILLAGE
MAHABOOBNAGAR
DISTRICT ANDHRA
PRADESH
2215 NDA/MAL/H ASTRA MACNAUGHTON ATACAND CANDESARTA 16 MG + ASTRA ZENECA AB, UNITED ORAL SOLID 1.0X2.0X1 7/1/2010
DP/4411 ZENECA LIMITED PLUS N+ 12.5 MG SODERTALJE- KINGDOM ORDINARY 4.0
HYDROCHLOR GARTUNAYEGEN, TABLETS TABLET
OTHIAZIDE SODERTALJE BLISTER
2216 NDA/MAL/H AUROBINDO PHILLIPS M-KAST 5 MONTELUKAS 5MG AUROBINDO PHARMA LTD INDIA ORAL SOLID 1.0X3.0X1 7/1/2016
DP/4412 PHARMA PHARMACEUTIC T SODIUM UNIT VII (SEZ) APIIC-PLOT ORDINARY 0.0
LIMITED ALS (UGANDA) NO. S1 SURVEY NO. CHEWABLE TABLET
LIMITED 411,425,434,435 & 458 TABLETS BLISTER
GREEN INDUSTRIAL PARK
POLEPALLY VILLAGE
MAHABOOBNAGAR
DISTRICT ANDHRA
PRADESH
2217 NDA/MAL/H EGYPTIAN WIDE EPICEPHIN CEFTRIAXONE 1G EGYPTIAN EGYPT PARENTERAL 1.0X1.0 G 7/1/2011
DP/4413 INTERNATION SPECTRUM INTERNATIONAL ORDINARY VIAL + 2
AL ENTERPRISES PHARMACEUTICAL DRY VIALS PLASTIC
PHARMACEUT (U) LIMITED INDUSTRIES COMPANY- AMPOULE
ICAL 10TH OF RAMADAN CITY S OF WFI
COMPANY
2218 NDA/MAL/H NOVARTIS SURGIPHARM CATAFLAM DICLOFENAC 50MG NOVARTIS PHARMA SPA,- ITALY ORAL SOLID 10.0X10.0 7/1/1997
DP/4415 PHARMA AG (U) LIMITED 5OMG POTASSIUM TORRE ANNUNZIATA ORDINARY TABLET
TABLETS ITALY NOVARTIS-- COATED BLISTER,1.
URUNLERI INSTABUL TABLETS 0X2.0X10.
TURKEY 0 TABLET
BLISTER
2219 NDA/MAL/H EGYPTIAN WIDE EPICEPHIN CEFTRIAXONE 500MG EGYPTIAN EGYPT PARENTERAL 1.0X0.5 G 7/1/2014
DP/4417 INTERNATION SPECTRUM SODIUM INTERNATIONAL ORDINARY VIAL +
AL ENTERPRISES PHARMACEUTICAL DRY VIALS 1*5 ML
PHARMACEUT (U) LIMITED INDUSTRIES COMPANY- OF WFI
ICAL 10TH OF RAMADAN CITY GLASS
INDUSTRIES FIRST INDUSTRIAL AREA AMPOULE
COMPANY S
2220 NDA/MAL/H MEDOCHEMIE BOOTS VALORAN CEFOTAXIME 1000MG MEDOCHEMIC LTD-1-10 CYPRUS PARENTERAL 1.0X10.0 7/1/2009
DP/4418 LTD PHARMACEUTIC ASTRONAFTON & ORDINARY VIAL
ALS LIMITED CONSTANTINOPOLEOS DRY VIALS CARTON
3505 LIMASSOL
2221 NDA/MAL/H EGYPTIAN WIDE EPIGONAL HUMAN 75IU/5ML EGYPTIAN EGYPT PARENTERAL 1.0X5.0 7/1/2010
DP/4419 INTERNATION SPECTRUM 75 MENOPAUSA INTERNATIONAL ORDINARY ML VIAL +
AL ENTERPRISES L PHARMACEUTICAL VIALS 1 ML
PHARMACEUT (U) LIMITED GONADOTRO INDUSTRIES COMPANY- AMPOULE
ICAL PHIN 10TH OF RAMADAN CITY 0.9%W/V
INDUSTRIES FIRST INDUSTRIAL AREA NACL
COMPANY
2222 NDA/MAL/H RENE RENE REQUIN FC QUININE 300MG RENE INDUSTRIES LTD- UGANDA ORAL SOLID 1.0X1000. 7/1/2011
DP/4425 INDUSTRIES INDUSTRIES PLOT 680, KAMULI ROAD, ORDINARY 0 TABLET
LTD LIMITED KIREKA, P.O BOX 6034, FILM- CONTAIN
KAMPALA COATED ER
TABLETS
2223 NDA/MAL/H AUROBINDO PHILLIPS TOPRAZ 40 PANTOPRAZO 40MG AUROBINDOPHARMA INDIA ORAL SOLID 1.0X3.0X1 7/1/2016
DP/4468 PHARMA LTD PHARMACEUTIC LE SODIUM LIMITED,-UNIT VII, SEZ ORDINARY 0.0
ALS (UGANDA) SESQUIHYDR APIIC, PLOT NO.SI SURVEY ENTERIC- TABLET
LIMITED ATE NO’S 425, 434,435 & 458 COATED BLISTER
GREEN INDUSTRIAL PARK, TABLETS
POLEPALLY
VILLAGEJEDCHERTA
MANDAL,
MAHABOOBNAGAR
DISTTRICT, ANDRA
PRADESH, INDIA.
AUROBINDO UNIT XV-
2224 NDA/MAL/H MEGA ABACUS KIPEL 5 MONTELUKAS 5MG MSN LABORATORIES PVT. INDIA ORAL SOLID 1.0X3.0X1 7/1/2016
DP/4480 LIFESCIENCES PHARMA T LIMITED-PLOT NO. 42 ORDINARY 0.0
(AUSTRALIA) (AFRICA) ANRICH INDUSTRIAL CHEWABLE TABLET
PTY LTD LIMITED ESTATE, BOLLARAM TABLETS BLISTER
MEDAK DISTRICT
PIN CODE 502 325
ANDHRA PRADESH, INDIA.
2225 NDA/MAL/H ARISTO NORVIK S- AMLODIPINE 5MG ARISTO INDIA ORAL SOLID 1.0X10.0X 7/1/2007
DP/4519 PHARMACEUT ENTERPRISES AMLOSAFE BESILATE PHARMACEUTICALS PVT ORDINARY 10.0
ICALS LTD LIMITED 5 LTD-PLOT NO 208 NEW TABLETS TABLET
INDUSTRIAL AREA N0 11 BLISTER
MANDIDEEP
2226 NDA/MAL/H ARISTO NORVIK S- AMLODIPINE 2.5 MG ARISTO INDIA ORAL SOLID 1.0X10.0X 7/1/2007
DP/4522 PHARMACEUT ENTERPRISES AMLOSAFE BESILATE PHARMACEUTICALS PVT ORDINARY 10.0
ICALS PVT LTD LIMITED 2.5 LTD-PLOT NO 208 NEW OTHER TABLET
INDUSTRIAL AREA N0 11 TABLETS BLISTER
MANDIDEEP
2227 NDA/MAL/H ARISTO NORVIK BIGOMET METFORMIN 500MG ARISTO INDIA ORAL SOLID 1.0X3.0X1 7/1/2008
DP/4523 PHARMACEUT ENTERPRISES SR 500 HYDROCHLOR PHARMACEUTICALS PVT. RETARD 0.0
ICALS PVT LTD LIMITED IDE LIMITED-PLOT NO. 208, TABLETS TABLET
NEW INDUSTRIAL AREA BLISTER
NO.II,MANDIDEEEP
PRADESH
2228 NDA/MAL/H DELORBIS ABACUS FLUCOZAL FLUCONAZOL 150MG DELORBIS CYPRUS ORAL SOLID 1.0X1.0 7/1/2008
DP/4524 PHARMACEUT PHARMA 150 E PHARMACEUTICALS LTD- ORDINARY CAPSULE
ICALS LTD (AFRICA) 17, ATHINON STREET, CAPSULES BLISTER
LIMITED ERGATES INDUSTRIAL
BOX 28629, 2081
LEFKOSIA
DP/4526 PHARMACEUT PHARMACEUTIC N NO.33,SECTOR ORDINARY TABLET
E INDIA
2230 NDA/MAL/H ARISTO NORVIK PIOSAFE PIOGLITAZON 15 MG + ARISTO INDIA ORAL SOLID 1.0X3.0X1 7/1/2008
DP/4528 PHARMACEUT ENTERPRISES MF 15/500 E + 500 MG PHARMACEUTICALS PVT ORDINARY 0.0
ICALS PVT LTD LIMITED METFORMIN LIMITED-PLOT 208, NEW TABLETS TABLET
INDUSTRIAL AREA NO II, BLISTER
MANDIDEEP-462 046
(DISTRICT) RAISEN,
2231 NDA/MAL/H DELORBIS ABACUS TREDOL ATENOLOL 100MG DELORBIS CYPRUS ORAL SOLID 1.0X2.0X1 7/1/2008
ICALS LTD (AFRICA) 17, ATHINON STREET, TABLETS TABLET
LIMITED ERGATES INDUSTRIAL BLISTER,1.
AREA, 2643 ERGATES P.O. 0X3.0X10.
BOX 28629, 2081 0 TABLET
LEFKOSIA BLISTER
2232 NDA/MAL/H DELORBIS ABACUS TREDOL 50 ATENOLOL 50MG DELORBIS CYPRUS ORAL SOLID 1.0X2.0X1 7/1/2008
BOX 28629, 2081
LEFKOSIA
2233 NDA/MAL/H DELOBORIS ABACUS VIRUCID ACICLOVIR 400 MG DELORBIS CYPRUS ORAL SOLID 1.0X3.0X1 7/1/2008
ICALS LTD (AFRICA) 17, ATHINON STREET, OTHER TABLET
LIMITED ERGATES INDUSTRIAL TABLETS BLISTER
BOX 28629, 2081
LEFKOSIA
2234 NDA/MAL/H DELOBORIS ABACUS LORYTEC 10 LORATADINE 10MG DELORBIS CYPRUS ORAL SOLID 1.0X1.0X1 7/1/2007
ICALS LTD (AFRICA) 17 ATHINON STR., TABLETS TABLET
BOX 28629, 2081
LEFKOSIA, CYPRUS
2235 NDA/MAL/H DELORBIS ABACUS CLERON CLARITHROM 250MG AEGIS LTD-17 ATHINON CYPRUS ORAL SOLID 1.0X2.0X7 7/1/2008
DP/4535 PHARMACEUT PHARMA 250 YCIN STREET, ERGATON ORDINARY .0 TABLET
ICALS LTD (AFRICA) INDUSTRIAL AREA, COATED BLISTER
LIMITED NICOSIA CYPRUS TABLETS
2236 NDA/MAL/H SEDICO WIDE FLUCAMOX FLUCLOXACIL 250MG+25 SEDICO PHARMACEUTICAL EGYPT ORAL SOLID 1.0X4.0X4 7/1/2004
DP/4536 PHARMACEUT SPECTRUM LIN + 0MG CO.-1ST INDUSTRIAL ZONE ORDINARY .0
ICAL CO. ENTERPRISES AMOXICILLIN 6 TH OCTOBER CITY CAPSULES CAPSULE
(U) LIMITED GIZA,EGYPT STRIP
2237 NDA/MAL/H VENUS AARON CRISTOL VINCRISTINE 1MG VENUS REMIDIES LTD- INDIA PARENTERAL 1.0X1.0X1 7/1/2009
DP/4539 REMEDIES PHARMACEUTIC SULPHATE UNIT-11 HILL TOP ORDINARY .0 ML
LTD ALS LTD INDUSTRIAL ESTATE VIALS VIAL
JHARMATI
2238 NDA/MAL/H DELORBIS ABACUS VIPROLOX CIPROFLOXAC 500MG DELORBIS CYPRUS ORAL SOLID 1.0X1.0X1 7/1/2008
DP/4540 PHARMACEUT PHARMA 500 IN PHARMACEUTICALS LTD- ORDINARY 0.0
ICALS LTD (AFRICA) 17, ATHINON STREET, FILM- TABLET
LIMITED ERGATES INDUSTRIAL COATED BLISTER
AREA, 2643 ERGATES P.O. TABLETS
BOX 28629, 2081
LEFKOSIA
2239 NDA/MAL/H DELORBIS ABACUS CLERON CLARITHROM 500MG DELORBIS CYPRUS ORAL SOLID 1.0X1.0X1 7/1/2008
DP/4542 PHARMACEUT PHARMA 500 YCIN PHARMACEUTICALS LTD- ORDINARY 4.0
ICALS LTD (AFRICA) 17, ATHINON STREET, FILM- TABLET
LIMITED ERGATES INDUSTRIAL COATED BLISTER
AREA, 2643 ERGATES P.O. TABLETS
BOX 28629, 2081
LEFKOSIA
2240 NDA/MAL/H SANOFI- SURGIPHARM RHINATHIO CARBOCISTEI 5%W/V NATTERMAN & CIE , GERMANY ORAL LIQUID 1.0X125.0 7/1/2015
DP/4543 AVENTIS (U) LIMITED L 5% NE GMBH ORDINARY ML
NATTERMANNALLEE 1 - SYRUPS BOTTLE
,50829 COLOGNE ,
GERMANY
2241 NDA/MAL/H COSMOS LTD ASTRA PHARMA SALBUT SALBUTAMOL 4MG COSMOS LIMITED-- KENYA ORAL SOLID 10.0X10.0 7/1/2000
DP/4544 (U) LIMITED TABLET RANGWA ROAD, OFF ORDINARY TABLET
4MG LUNGA LUNGA ROAD,P.O FILM- BLISTER,1.
BOX 414 33, NAIORBI COATED 0X100.0
INDUSTRIAL AREA TABLETS TABLET
CONTAIN
ER
2242 NDA/MAL/H CACHET ASTRA PHARMA CACH-ART ARTEMETHER 20 MG + CACHET INDIA ORAL SOLID 1.0X3.0X8 7/1/2010
DP/4545 PHAMACUITIC (U) LIMITED 20/120 + 120 MG PHARMACEUTICALS PVT ORDINARY .0 TABLET
ALS PVT LTD LUMEFANTRI LTD-VILLAGE AND POST FILM- BLISTER
NE THANA BADDI TEHSIL COATED
NALAGARH SOLAN TABLETS
DISTRICT HIMACHAL
PRADESH 173 205
2243 NDA/MAL/H KARNATAKA TATA UGANDA CHLORAMP CHLORAMPH 1G KARNATAKA ANTIBIOTICS INDIA PARENTERAL 1.0X100.0 7/1/1998
DP/4546 ANTIBIOTICS LIMITED HENICOL ENICOL & PHARMACEUTICALS LTD- ORDINARY X1.0 G
& INJECTION SODIUM #14, II PHASE PIA, DRY VIALS VIAL,1.0X
PHARMACEUT IG SUCCINATE BANGALORE 560058 50.0X1.0
ICALS LTD G VIAL
2244 NDA/MAL/H SANOFI SURGIPHARM RHINATHIO CARBOCISTEI 20MG/ML UNITHER LIQUID FRANCE ORAL LIQUID 1.0X125.0 7/1/2001
DP/4550 AVENTS (U) LIMITED L 2% NE MANUFACTURING ORDINARY ML
FRANCE INDUSTRIE -COLOMIERS 1- SYRUPS BOTTLE
3 ALLE DE LA NESTE L DEN
SIGAL 31770 A.
NATTERMANN & CIE
GMBH.-
NATTERMANNALLEE 1
,50829 COLOGNE,
GERMANY
2245 NDA/MAL/H GUILIN STAR ARTESUN ARTESUNATE 30MG GUILIN PHARMACEUTICAL CHINA PARENTERAL 1.0X30.0 7/1/2011
DP/4553 PHARMACEUT PHARMACEUTIC CO. LTD.-NO. 43 QILIDIAN ORDINARY MG VIAL
ICALS CO.LTD ALS LTD ROAD, GUILIN 541004 DRY VIALS + 1*0.5
ML
SODIUM
BICARBO
NATE
2246 NDA/MAL/H UNIQUE PLANET IFICIPRO CIPROFLOXAC 500MG UNIQUE INDIA ORAL SOLID 1.0X10.0X 7/1/2005
DP/4558 PHARMACEUT PHARMACEUTIC 500 IN PHARMACEUTICALS LABS ( ORDINARY 10.0
ICALS ALS UGANDA A DIV OF J.B CHEMICALS & FILM- TABLET
LABORATORIE LTD PHARMACEUTICAL LTD)-- COATED BLISTER
S 304-308 ,GIDC , PANOLI TABLETS
394116
2247 NDA/MAL/H MSN METRO PREGASAFE PREGABALIN 75MG MSN LABORATORIES LTD- INDIA ORAL SOLID 1.0X3.0X1 7/1/2014
DP/4559 LABORATORIE PHARMACEUTIC 75 PLOT 42 ANRICH ORDINARY 0.0
S PRIVATE ALS LIMITED INDUSTRIAL ESTATE CAPSULES CAPSULE
LIMITED BOLLARAM MEDAK BLISTER
PRADESH
2248 NDA/MAL/H TORRENT KARURI LORVAS SR INDAPAMIDE 1.5MG TORRENT INDIA ORAL SOLID 1.0X3.0X1 7/1/2009
ICALS LTD ALS LTD. VILLAGE. BHUD-MAKHNU FILM- TABLET
MAJRA, TEHSIL: BADDI COATED CONTAIN
173205 DIST SOLAN (H.P) TABLETS ER
2249 NDA/MAL/H TATA TATA UGANDA QUININE QUININE 300MG/ML GLAND PHARMA LTD .- INDIA PARENTERAL 1.0X10.0X 7/1/2008
DP/4563 UGANDA LIMITED DIHYDROC DIHYDROCHL D.P. PALLY, SURVEY 143- ORDINARY 2.0 ML
LIMITED HLORIDE ORIDE 148, 150& GLAND AMPOULES AMPOULE
INJECTION PHARMA LTD-PLOT NO. 42
TO 52, SY NO. 166, 171,
DISTRICT 502307,
TELANGANA STATE
2250 NDA/MAL/H TATA TATA UGANDA FUROSEMI FUROSEMIDE 10MG/ML GLAND PHARMA LTD .- INDIA PARENTERAL 1.0X10.0X 7/1/2009
DP/4566 UGANDA LIMITED DE D.P. PALLY, SURVEY 143- ORDINARY 2.0 ML
LIMITED INJECTION 148, 150& GLAND AMPOULES AMPOULE
BP PHARMA LTD-PLOT NO. 42
TO 52, SY NO. 166, 171,
DISTRICT 502307,
TELANGANA STATE
2251 NDA/MAL/H ALKEM ABACUS CLAVAM AMOXICILLIN 500MG + ALKEM LABORATORIES INDIA ORAL SOLID 1.0X2.0X1 7/1/2005
DP/4568 LABORATORIE PHARMA 625 TRIHYDRATE 125MG LTD--167/1, VILLAGE ORDINARY 0.0
S LIMITED (AFRICA) + DABHEL, AMALIYA FILM- TABLET
LIMITED CLAVULANAT DAMAN-396210, INDIA COATED STRIP
E POTASSIUM TABLETS
2252 NDA/MAL/H AUROBINDO GITTOES NEVIRAPIN NEVIRAPINE 200MG AUROBINDO PHARMA LTD- INDIA ORAL SOLID 1.0X60.0 7/1/2005
DP/4570 PHARMA LTD PHARMACEUTIC E UNIT III-SURVEY ORDINARY TABLET
R MANDAL R.R
DISTRICT(A.P),INDIA
2253 NDA/MAL/H ASTRA ASTRA PHARMA ASPICLOX AMPICILLIN + 250 MG + ASTRA LIFE CARE (INDIA) INDIA ORAL SOLID 10.0X10.0 7/1/1997
DP/4571 PHARMA (U) (U) LIMITED CLOXACILLIN 250 MG PVT.LTD-PLOT NO. 57/P, ORDINARY CAPSULE
LIMITED SARKHEJ-BAVLA CAPSULES STRIP,1.0X
HIGHWAY, POST RAJODA- 1000.0
382220, TALUKA BAVLA, CAPSULE
AHMEDABAD INDIA CONTAIN
ER
2254 NDA/MAL/H FDC LTD AIVEEN (U) PYRICORT DEXAMETHAS FDC LIMITED -B-8, INDIA OPHTHALMI 1.0X5.0 7/1/2010
DP/4575 LIMITED EYE/EAR ONE+GENTA 0.1%+0.3% M.I.D.C., INDUSTRIAL C DROPS ML
DROPS MICIN W/V AREA, WALUJ – BOTTLE
AURANGABAD- 431 136
MAHARASHTRA, INDIA.
2255 NDA/MAL/H ALKEM ABACUS MAGTAM CEFOPERAZO 500 MG + ALKEM LABORATORIES INDIA PARENTERAL 1.0X1.0 G 7/1/2011
DP/4577 LABORATORIE PHARMA NE + 500 MG LIMITED.-VILLAGE THANA, ORDINARY VIAL
S LIMITED (AFRICA) SULBACTAM BADDI, TEHSIL- DRY VIALS
(HP), INDIA-173205
2256 NDA/MAL/H ACINO GOODMAN MESPORIN CEFTRIAXONE 500MG LABESFAL LABORATORIOS PORTUGAL PARENTERAL 1.0X500.0 7/1/2005
DP/4579 PHARMA AG INTERNATIONAL 500 IV ALMIRO, S.A ,.-ZONA ORDINARY MG VIAL
LTD VIALS INDUSTRIAL DO LABENGO, DRY VIALS + 1*5 ML
3465-157 SANTIAGO DE WFI
BESTEIROS AMPOULE
2257 NDA/MAL/H CIRON DRUGS RENE CIRATRO ATROPINE 1MG/ML CIRON DRUGS AND INDIA PARENTERAL 1.0X10.0X 7/1/2008
DP/4587 AND PHARMACY LTD PHARMACEUTICALS PVT ORDINARY 10.0X1.0
PHARMACEUT LTD-N-118 M.I.D.C, AMPOULES ML
ICALS PVT LTD TAAPUR,BOISAR,DIST.THA AMPOULE
2258 NDA/MAL/H LINCOLN METRO FLUCAN FLUCONAZOL 200MG LINCOLN INDIA ORAL SOLID 1.0X10.0X 7/1/2011
DP/4588 PHARMACEUT PHARMACEUTIC 200 E PHARMACEUTICAL ORDINARY 1.0
ICALS LTD ALS LIMITED LIMITED-TRIMAL ESTATE TABLETS TABLET
INDIA
2259 NDA/MAL/H FEROZSONS HARLEYS LEFOXCIN- LEVOFLOXACI 500MG FEROZSONS PAKISTAN ORAL SOLID 1.0X10.0 7/1/2013
DP/4589 LABORATORIE UGANDA 500 N LABORATORIES LTD- ORDINARY TABLET
S LTD LIMITED HEMIHYDRAT AMANGARH-NOWSHERA, TABLETS BLISTER
E (KHYBER
PAKHTOONKHWA),
PAKISTAN
2260 NDA/MAL/H S KAGE ABACUS SILVER SILVER 1%W/W S.KANT HEALTHCARE LTD- INDIA TOPICAL 1.0X15.0 7/1/2009
DP/4591 EXPORTS PHARMA KANT SULPHADIAZI 1802-18-5 GIDC PHASE III, EXTERNAL G TUBE
(AFRICA) NE USP VAPI-396195,GUJARAT CREAMS
LIMITED INDIA
2261 NDA/MAL/H LINCOLN METRO PENTALINK PANTOPRAZO 40MG LINCOLN INDIA ORAL SOLID 1.0X10.0X 7/1/2008
DP/4592 PHARMACEUT PHARMACEUTIC 40 LE PHARMACEUTICAL ORDINARY 10.0
ICALS LTD ALS LIMITED LIMITED-TRIMAL ESTATE ENTERIC- TABLET
KHATRAJ KOLOL,GUJARAT COATED STRIP,1.0X
INDIA TABLETS 3.0X10.0
TABLET
BLISTER
2262 NDA/MAL/H SK AGE ABACUS ERYTHROK ERYTHROMYC 250MG S.KANT HEALTHCARE LTD- INDIA ORAL SOLID 1.0X10.0X 7/1/2011
DP/4593 EXPORTS PHARMA ANT-250 IN STEARATE PLOT 1802, 1805, GIDC ORDINARY 10.0
(AFRICA) PHASE III VAPI 39179, FILM- TABLET
LIMITED GUJARAT COATED BLISTER
TABLETS
2263 NDA/MAL/H CADILA ABACUS TINIBA-500 TINIDAZOLE 500MG CADILA HEALTH CARE INDIA ORAL SOLID 1.0X60.0X 7/1/1997
DP/4594 HEALTH CARE PHARMA TABLETS LIMITED-KUNDAIM ORDINARY 4.0
LIMITED (AFRICA) INDUSTRIAL ESTATE, TABLETS TABLET
LIMITED PONDA, GOA-403401, BLISTER,1.
INDIA. 0X25.0X4.
. 0 TABLET
BLISTER
2264 NDA/MAL/H LINCOLN METRO VAST-20 ATORVASTATI 20MG LINCOLN INDIA ORAL SOLID 1.0X10.0X 7/1/2010
DP/4595 PHARMACEUT PHARMACEUTIC N PHARMACEUTICAL ORDINARY 10.0
ICALS LTD ALS LIMITED LIMITED-TRIMAL ESTATE FILM- TABLET
KHATRAJ KOLOL,GUJARAT COATED BLISTER,1.
INDIA TABLETS 0X3.0X10.
0 TABLET
BLISTER
2265 NDA/MAL/H INDOCO STAR TRIZ CETIRIZINE 10MG INDOCO REMEDIES LTD, B- INDIA ORAL SOLID 1.0X2.0X5 7/1/2001
DP/4596 REMEDIES PHARMACEUTIC TABLETS 20,-B-20 MIDC, WALUJ, ORDINARY .0X10.0
LTD ALS LTD AURANGABAB 431136 TABLETS BLISTER
INDIA BLISTER,1.
0X5.0X5.0
X10.0
TABLET
BLISTER
DP/4598 PHARMACEUT PHARMACEUTIC N NO.33,SECTOR ORDINARY TABLET
E INDIA
2267 NDA/MAL/H SANOFI LABOREX PENTAXIM MULTI- MULTI- SANOFI PASTEUR-1541 FRANCE PARENTERAL 1.0X0.5 7/1/2010
DP/4601 PASTEUR UGANDA VACCINE INGREDIENT INGREDIEN AVENUE MARCEL ORDINARY I ML PRE-
LIMITED T MERIEUX, 69280 MARCY, M PRE- FILLED
LETOILE SANOFI PASTEUR FILLED SYRINGE,1
S.A-2,AVENUE PONT SYRINGES .0X0.5 ML
PASTEUR 69007 LYON- VIAL
FRANCE(BUSINESS
ADDRESS)
2268 NDA/MAL/H ELI-LILLY LABOREX HUMALOG INSULIN 100 .IU(50 LILLY FRANCE SA-FRANCE FRANCE PARENTERAL 1.0X3.0 7/1/2000
DP/4602 (SUISSE) SA UGANDA MIX 50 LISPRO I.U+50 I.U) ORDINARY S ML
LIMITED C VIALS VIAL,1.0X
5.0 ML
VIAL
2269 NDA/MAL/H REMEDICA GOODMAN HALOXEN - HALOPERIDO 5MG REMEDICA LIMITED- CYPRUS ORAL SOLID 1.0X10.0X 7/1/2005
DP/4603 LTD INTERNATIONAL 5 L LIMASSOL INDUSTRIAL ORDINARY 10.0
BLISTER
2270 NDA/MAL/H GITTOES GITTOES AGODRYL BROMHEXINE 4MG/5ML+ AGOG PHARMA LTD-PLOT INDIA ORAL LIQUID 1.0X1.0X1 7/1/2009
DP/4605 PHARMACEUT PHARMACEUTIC SYRUP HCL+DEXTRO 5MG/5ML+ NO.33,SECTOR ORDINARY 00.0 ML
ICALS LIMITED ALS LIMITED METHORPHA 50MG/5ML II,VASAI,TALUKA INDL CO- SYRUPS BOTTLE,1.
N +2.5MG/5 OP ESTATE LTD,GAURAI 0X1.0X60.
HBR+AMMO ML PADA,VASAI(E)DIST.THAN 0 ML
NIUM E INDIA BOTTLE
CHLORIDE+M
ENTHOL
DP/4606 PHARMACEUT ENTERPRISES N LIMITED(BIOPHARMA ORDINARY 0.0
ICALS LIMITED LIMITED DIVISION)-CAMP ROAD TABLETS TABLET
DEHRADUN
(UTTARAKHAND) INDIA
2272 NDA/MAL/H ELYS VELVET ELYCORT HYDROCORTI 1%W/W ELYS CHEMICAL KENYA TOPICAL 1.0X15.0 7/1/1997
DP/4609 CHEMICAL PHARMA SONE INDUSTRIES LTD-ROAD 'B' EXTERNAL G TUBE
INDUSTRIES LIMITED OFF ENTERPRISE ROAD, CREAMS
LTD INDUSTRIAL AREA
NAIROBI
2273 NDA/MAL/H GALENTIC VITACARE COMPOUN BENZOIC 6 %W/W + GALENTIC PHARMA( INDIA INDIA TOPICAL 1.0X25.0 7/1/2006
DP/4614 PHARMA LTD LIMITED D BENZOIC ACID + 3 %W/W ) PVT LTD-R-673,MIDC TTC EXTERNAL G
ACID SALICYLIC RABALE THANE-BELAPUR OINTMENTS TUBE,1.0X
OINTMENT ACID ROAD,NAVI 500.0 G
TUBE
2274 NDA/MAL/H NVS KENYA SURGIPHARM TASIGNA NILOTONIB 150MG NOVARTIS PHARMA STEIN SWITZERLAN ORAL SOLID 1.0X7.0X4 7/1/2014
DP/4615 LTD (U) LIMITED 150 HYDROCHLOR AG- D ORDINARY .0
IDE SCHAFFHARVSERTRASSE CAPSULES CAPSULE
MONOHYDRA CH-4332 STEIN BLISTER
TE SWITZERLAND.
DP/4617 ZENECA LIMITED N INC,-LOT 17 INDUSTRIAL ORDINARY 4.0
TABLETS
2276 NDA/MAL/H GLAXO SMITH UNITED MALANIL ATOVAQUON 62.5 MG + GLAXO WELLCOME S.A SPAIN ORAL SOLID 1.0X1.0X1 7/1/2007
DP/4620 KLINE LTD HEALTHCARE PAEDIATRIC E + 25.0 MG ARANDA-ARANDA AVDA ORDINARY 2.0
DISTRIBUTORS TABLET PROGUANIL EXTREMADURA 3, 09400 FILM- TABLET
LTD ARANDA DE DUERO COATED BLISTER
BURGOS TABLETS
2277 NDA/MAL/H CADILA ABACUS CARVIL 6.25 CARVEDILOL 6.25MG CADILA HEALTHCARE LTD-- INDIA ORAL SOLID 10.0X10.0 7/1/2006
DP/4621 HEALTHCARE PHARMA PLOT 203-213, KUNDAIM ORDINARY TABLET
LTD (AFRICA) INDUSTRIAL ESTATE, GOA TABLETS BLISTER
LIMITED 403401
2278 NDA/MAL/H RENE RENE CLOXAREN CLOXACILLIN 250MG RENE INDUSTRIES-PLOT UGANDA ORAL SOLID 10.0X10.0 7/1/2007
DP/4622 INDUSTRIES INDUSTRIES 680 KAMULI KIREKA ORDINARY CAPSULE
LIMITED LIMITED CAPSULES BLISTER
2279 NDA/MAL/H RENE RENE LOPERARE LOPERAMIDE 2MG RENE INDUSTRIAL LTD- UGANDA ORAL SOLID 1.0X10.0X 7/1/2007
DP/4623 INDUSTRIES INDUSTRIES N HYDROCHLOR RENE INDUSTRIES LTD, ORDINARY 10.0
LIMITED LIMITED IDE PLOT 680, KAMULI-KIREKA CAPSULES CAPSULE
KAMPALA UGANDA BLISTER
2280 NDA/MAL/H ACINO GOODMAN GASEC-20 OMEPRAZOLE 20MG ACINO PHARMA AG - SWITZERLAN ORAL SOLID 1.0X1.0X1 7/1/2005
DP/4626 PHARMA AG INTERNATIONAL DORNACHERSTRASSE, 114, D ORDINARY 4.0
LTD 4147, AESCH, CAPSULES CAPSULE
SWITZERLAND BOTTLE
2281 NDA/MAL/H LABORATORY HARLEYS HYCORUM HYDROCORTI 1%W/W LABORATORY AND ALLIED KENYA TOPICAL 1.0X15.0 7/1/1997
DP/4627 AND ALLIED UGANDA CREAM SONE LTD-PLOT 209/10349- EXTERNAL G TUBE
LTD LIMITED MOMBASA ROAD NAIROBI CREAMS
2282 NDA/MAL/H DAWA SUPER MEDIC ORACEF CEFALEXIN 125MG/5 DAWA LTD-BABA DOGO KENYA ORAL LIQUID 1.0X100.0 7/1/2015
DP/4629 LIMITED LTD MONOHYDRA ML ROAD RUARAKA ORDINARY ML
TE DRY BOTTLE
SUSPENSION
S/SYRUPS/D
ROPS
2283 NDA/MAL/H AMANTA PHARMA VILLE METRONID METRONIDAZ 5MG/ML MARCK BIOSCIENCES INDIA PARENTERAL 1.0X100.0 7/1/2014
DP/4633 HEALTHCARE LIMITED AZOLE OLE LIMITED. .-PLOT 876, NH ORDINARY ML
LTD INFUSION NO. 8, HARIYALA, KHEDA- INFUSION BOTTLE
387411, GUJARAT VIALS/BOTTL
ES
2284 NDA/MAL/H DENK BENLE CONSULT LOSAR- LOSARTAN 100MG DENK PHARMA GMBH & GERMANY ORAL SOLID 1.0X2.0X1 7/1/2011
DP/4634 PHARMA LIMITED DENK 100 CO.-PRINZREGENTENSTR. ORDINARY 4.0
GMB H &CO. 79, 81675 MÜNCHEN, FILM- TABLET
KG GÖLLSTR. 1, 84529 COATED BLISTER
TITTMONING, GERMANY TABLETS
2285 NDA/MAL/H DELORBIS ABACUS ZOLARAM ALPRAZOLAM 0.5MG DELORBIS CYPRUS ORAL SOLID 1.0X3.0X1 7/1/2009
DP/4636 PHARMACEUT PHARMA 0.5 PHARMACEUTICALS LTD- ORDINARY 0.0
BOX 28629, 2081
LEFKOSIA
2286 NDA/MAL/H ABACUS ABACUS PARACETA PARACETAM 500MG HEBEI (JIHENG GRP) CHINA ORAL SOLID 1.0X10.0X 7/1/2016
DP/4637 PHARMA (A) PHARMA MOL OL PHARMACEUTICALS ORDINARY 10.0
LTD. (AFRICA) CO.LTD-368 JIANSHE ST TABLETS TABLET
LIMITED HENGSHUI CITY HEBEI BLISTER
053000
DP/4645 ZENECA LIMITED N CALCIUM INC,-LOT 17 INDUSTRIAL ORDINARY 4.0
TABLETS
2288 NDA/MAL/H CIPLA LTD.. QUALITY LEVOLIN LEVOSALBUT 50MCG CIPLA LTD.- -PLOT NO INDIA NASAL 1.0X200.0 7/1/2013
DP/4647 CHEMICALS LTD - AMOL L/139 TO L/146, VERNA SYSTEMIC METERED
HUMAN INDUSTRIAL ESTATE, METERED- DOSE
VERNA, SOUTH GOA DOSE CANNISTE
DISTRICT, 403722 GOA LIQUIDS R
2289 NDA/MAL/H NORVATIS LABOREX DUOTRAV TRAVOPROST 40MG/ML ALCON COUVREUR NV- BELGIUM OPHTHALMI 1.0X1.0X2 7/1/2010
DP/4650 PHARMA AG- UGANDA + TIMOLOL + 5MG/ML RIJKSWEG 14, B-2870 C DROPS .5 ML
SWITZERLAN LIMITED MALEATE PUURS BELGIUM VIAL
D
2290 NDA/MAL/H SERUM NORVIK SII TETANUS ≥ 5 LF (≥ 40 SERUM INSTITUTE OF INDIA PARENTERAL 1.0X5.0 7/1/1997
DP/4652 INSTITUTE OF ENTERPRISES TETANUS TOXOID IU) ON ≤ INDIA LTD-212/2 ORDINARY ML
INDIA LTD. LIMITED TOXOID ADSORBED 1.25 MG HADAPSAR, PUNE, 411028, AMPOULES AMPOULE
VACCINE ON OF INDIA (1 DOSE
ALUMINIUM ALUMINIU AMPOULE
PHOSPHATE M ),1.0X10.0
PHOSPHAT ML VIAL
E (20 DOSE
VIAL)
2291 NDA/MAL/H DAR AL DAWA GAMA VOLAR GABAPENTIN 300MG DAR AL DAWA-DAR AL JORDAN ORAL SOLID 1.0X3.0X1 7/1/2013
DP/4657 DEVELOPMEN PHARMACEUTIC 300MG DAWA DEVELOPMENT ORDINARY 0.0
T AND ALS (U) LIMITED AND INVESTMENT CO LTD. CAPSULES CAPSULE
INVESTMENT NA’UR PRINCE HASHEM BLISTER
CO LTD BIN AL-HUSSEIN STREET.
AMMAN, JORDAN
2292 NDA/MAL/H PT SANBE MEDVIN MEROSAN MEROPENEM 0.5G PT SANBE FARMA-JI INDONESIA PARENTERAL 1.0X0.5 G 7/1/2014
DP/4658 FARMA PHARMA 0.5 LEUWIGAJAH I62 CIMINDI ORDINARY VIAL
LIMITED CIMAHI WEST JAVA DRY VIALS
INDONESIA
2293 NDA/MAL/H DAR AL DAWA GAMA RISDONE RISPERIDONE 2MG DAR AL DAWA-DAR AL JORDAN ORAL SOLID 1.0X2.0X1 7/1/2013
DP/4660 DEVELOPMEN PHARMACEUTIC 2MG DAWA DEVELOPMENT ORDINARY 0.0
T AND ALS (U) LIMITED AND INVESTMENT CO LTD. FILM- TABLET
INVESTMENT NA’UR PRINCE HASHEM COATED BLISTER
CO LTD BIN AL-HUSSEIN STREET. TABLETS
AMMAN, JORDAN
2294 NDA/MAL/H ASTRA LIFE ASTRA PHARMA ASDOL TRAMADOL 50MG ASTRA LIFE CARE (INDIA) INDIA ORAL SOLID 1.0X10.0X 7/1/2011
DP/4662 CARE (INDIA) (U) LIMITED PVT.LTD-PLOT NO. 57/P, ORDINARY 10.0
PVT LTD SARKHEJ-BAVLA CAPSULES CAPSULE
AHMEDABAD INDIA
2295 NDA/MAL/H DAR AL DAWA GAMA LORATAN LORATIDINE 5MG/5ML DAR AL DAWA-DAR AL JORDAN ORAL LIQUID 1.0X100.0 7/1/2013
DP/4663 DEVELOPMEN PHARMACEUTIC DAWA DEVELOPMENT ORDINARY ML
T AND ALS (U) LIMITED AND INVESTMENT CO LTD. SYRUPS BOTTLE
INVESTMENT NA’UR PRINCE HASHEM
AMMAN, JORDAN
2296 NDA/MAL/H DAR AL DAWA GAMA ANTIPLEX CLOPIDOGREL 30MG DAR AL DAWA-NA'UR JORDAN ORAL SOLID 1.0X3.0X1 7/1/2013
DP/4666 DEVELOPMEN PHARMACEUTIC BISULFATE PLANT AMMAN ORDINARY 0.0
INVESTMENT COATED BLISTER
CO LTD TABLETS
2297 NDA/MAL/H DAR AL DAWA GAMA DICLOGESIC DICLOFENAC 100MG DAR AL DAWA-DAR AL JORDAN TOPICAL 1.0X5.0 7/1/2013
DP/4669 DEVELOPMEN PHARMACEUTIC 100MG SODIUM. DAWA DEVELOPMENT EXTERNAL SUPPOSIT
T AND ALS (U) LIMITED SUPPOSITO AND INVESTMENT CO LTD. ADULT ORY STRIP
INVESTMENT RIES NA’UR PRINCE HASHEM SUPPOSITORI
CO LTD BIN AL-HUSSEIN STREET. ES
AMMAN, JORDAN
2298 NDA/MAL/H DAR AL DAWA GAMA DICLOGESIC DICLOFENAC 100MG DAR AL DAWA-DAR AL JORDAN ORAL SOLID 1.0X2.0X6 7/1/2013
DP/4675 DEVELOPMEN PHARMACEUTIC RETARD SODIUM DAWA DEVELOPMENT ORDINARY .0
T AND ALS (U) LIMITED 100 AND INVESTMENT CO LTD. CAPSULES CAPSULE
AMMAN, JORDAN
2299 NDA/MAL/H : ALKEM ABACUS ZOCEF CEFUROXIME 125MG/5 ALKEM LABORATORIES INDIA ORAL LIQUID 1.0X1.0X3 7/1/2011
DP/4677 LABORATORIE PHARMA ML LIMITED.-VILLAGE THANA, ORDINARY 0.0 ML
S LIMITED√ (AFRICA) BADDI, TEHSIL- DRY BOTTLE,1.
LIMITED NALAGARH, DISTT-SOLAN, SUSPENSION 0X70.0 ML
(HP), INDIA-173205 S/SYRUPS/D BOTTLE
ROPS
2300 NDA/MAL/H : ALKEM ABACUS ZOCEF-500 CEFUROXIME 500MG ALKEM LABORATORIES INDIA ORAL SOLID 1.0X10.0 7/1/2009
DP/4678 LABORATORIE PHARMA AXETIL LIMITED.-VILLAGE THANA, ORDINARY TABLET
S LIMITED√ (AFRICA) BADDI, TEHSIL- TABLETS BLISTER
(HP), INDIA-173205
2301 NDA/MAL/H SANOFI SURGIPHARM INSUMAN DISSOLVED 30%+70% SANOFI-AVENTIS GERMANY PARENTERAL 1.0X5.0X3 7/1/2014
DP/4681 AVENTIS (U) LIMITED COMB 30 INSULIN+CRY DEUTSCHLAND GMBH - ORDINARY .0 ML
STALLINE INDUSTRIEPARK HOECHST, VIALS CARTRIDG
PROTAMINE BRUNINGSTRASSEN, E
INSULIN BUILDING
AM MAIN, GERMANY
2302 NDA/MAL/H AUROBINDO GITTOES LAMIVUDIN LAMIVUDINE 10MG/ML AUROBINDO PHARMA INDIA ORAL LIQUID 1.0X240.0 7/1/2006
DP/4682 PHARMA LTD PHARMACEUTIC E LIMITED-UNIT – III- ORDINARY ML
ALS LIMITED SURVEY NO.:313 & SYRUPS BOTTLE
314,BACHUPALLY
(VILLAGE)QUTHUBULLAPU
R MANDAL, RANGA REDDY
DISTRICT, TELANGANA
STATE.INDIA.
2303 NDA/MAL/H AUROBINDO GITTOES ZIDOVUDIN ZIDOVUDINE 50MG/5ML AUROBINDO PHARMA LTD INDIA ORAL LIQUID 1.0X240.0 7/1/2007
DP/4686 M PHARMA PHARMACEUTIC E ORAL .-UNIT III SURVEY NO.313 ORDINARY ML
LIMITED ALS LIMITED SOLUTION BACHU SUSPENSION BOTTLE
USP S
2304 NDA/MAL/H ELYS VELVET ELYPEN PHENOXYME 250MG ELYS CHEMICAL KENYA ORAL SOLID 1.0X10.0X 7/1/1997
DP/4690 CHEMICAL PHARMA THYL INDUSTRIES LTD-ROAD 'B' ORDINARY 10.0
INDUSTRIES LIMITED PENICILLIN OFF ENTERPRISE ROAD, TABLETS TABLET
LTD INDUSTRIAL AREA BLISTER,1.
NAIROBI 0X1000.0
TABLET
CONTAIN
ER
2305 NDA/MAL/H ELYS VELVET ELYVATE BETAMETHAS 1%W/W ELYS CHEMICAL KENYA TOPICAL 1.0X15.0 7/1/1997
DP/4693 CHEMICAL PHARMA ONE INDUSTRIES LTD-ROAD 'B' EXTERNAL G TUBE
INDUSTRIES LIMITED VALERATE OFF ENTERPRISE ROAD, OINTMENTS
LTD INDUSTRIAL AREA
NAIROBI
2306 NDA/MAL/H PT SAMBE MEDVIN SANBE AMOXICILLIN 1000 MG + PT SANBE FARMA-JI INDONESIA PARENTERAL 1.0X6.0 7/1/2011
DP/4697 FARMA PHARMA CLANEKSI + 200 MG LEUIGAJAH NO. 162 ORDINARY VIAL
LIMITED CLAVULANIC CIMINDI, INDONESIA VIALS CARTON
ACID
2307 NDA/MAL/H MEDIPHARM MEDIPHARM MEDIZOLE METRONIDAZ 125MG/5 MEDIPHARM INDUSTRIES UGANDA ORAL LIQUID 1.0X100.0 7/1/2006
DP/4700 SALES INDUSTRIES OLE ML (E.A) LTD-PLOT 65, ORDINARY ML
LIMITED (E.A) LTD KAKAJJO ROAD, SUSPENSION BOTTLE
BWEYOGERERE S
2308 NDA/MAL/H AFRICURE ROYAL PHARMA MEBRONE MEBENDAZOL 100MG AFRICURE INDIA ORAL SOLID 1.0X10.0X 7/1/1997
DP/4701 PHARMACEUT 2011 LIMITED 100 E PHARMACEUTICALS ORDINARY 10.0
ICALS (INDIA) TABLETS (INDIA) PRIVATE LIMITED- CHEWABLE TABLET
PRIVATE PLOT 9-12,DEWAN & SONS TABLETS BLISTER,1.
INDIA. BLISTER,1.
0X1000.0
TABLET
CONTAIN
ER
2309 NDA/MAL/H ABACUS ABACUS ABTOL MANNITOL 200MG/ML ABACUS PARENTERAL UGANDA PARENTERAL 1.0X100.0 7/1/2011
DP/4702 PARENTERAL PARENTERAL 20%W/V DRUGS LTD.-PLOT NO. ORDINARY ML
DRUGS DRUGS LIMITED 114, BLOCK 191, INFUSION BOTTLE
LIMITED GWAGAMYA, KINGA, VIALS/BOTTL
KAPEKE, ES
MUKONO
2310 NDA/MAL/H ABACUS ABACUS ABGYL METRONIDAZ 500MG ABACUS PARENTERAL UGANDA PARENTERAL 1.0X1.0X1 7/1/2011
DP/4703 PARENTERAL PARENTERAL OLE DRUGS LTD.-PLOT NO. ORDINARY 00.0 ML
DRUGS DRUGS LIMITED 114, BLOCK 191, INFUSION BOTTLE
LIMITED GWAGAMYA, KINGA, VIALS/BOTTL
KAPEKE, ES
MUKONO
2311 NDA/MAL/H DAR AL DAWA GAMA DICLOGESIC DICLOFENAC 12.5MG DAR AL DAWA-DAR AL JORDAN RECTAL 1.0X2.0X5 7/1/2012
DP/4704 DEVELOPMEN PHARMACEUTIC 12.5 SODIUM DAWA DEVELOPMENT SYSTEMIC .0
T AND ALS (U) LIMITED AND INVESTMENT CO LTD. SUPPOSITORI SUPPOSIT
INVESTMENT NA’UR PRINCE HASHEM ES ORY
CO LTD BIN AL-HUSSEIN STREET. BLISTER
AMMAN, JORDAN
2312 NDA/MAL/H DAR AL DAWA GAMA DICLOGESIC- DICLOFENAC 50MG DAR AL DAWA-DAR AL JORDAN RECTAL 1.0X2.0X5 7/1/2012
DP/4705 DEVELOPMEN PHARMACEUTIC 50 DAWA DEVELOPMENT SYSTEMIC .0
T AND ALS (U) LIMITED AND INVESTMENT CO LTD. SUPPOSITORI SUPPOSIT
INVESTMENT NA’UR PRINCE HASHEM ES ORY
CO LTD BIN AL-HUSSEIN STREET. BLISTER
AMMAN, JORDAN
2313 NDA/MAL/H WIN- SURGIPHARM DICLOMOL DICLOFENAC 25MG/ML WIN MEDICARE PVT INDIA PARENTERAL 1.0X3.0 7/1/1998
DP/4707 MEDICARE (U) LIMITED INJECTION SODIUM LIMITED-MEERUT, ORDINARY ML
PVT LTD MUZAFFARNAGER ROAD, AMPOULES AMPOULE
MODIPURAM – 250110,
UTTAR
PRADESH - INDIA
2314 NDA/MAL/H MEDIPHARM MEDIPHARM MEDIFEN IBUPROFEN 100MG/5 MEDIPHARM INDUSTRIES UGANDA ORAL LIQUID 1.0X60.0 7/1/2006
DP/4708 SALES INDUSTRIES ML (E.A) LTD-PLOT 65, ORDINARY ML
LIMITED (E.A) LTD KAKAJJO ROAD, SUSPENSION BOTTLE
BWEYOGERERE S
2315 NDA/MAL/H COSMOS LTD ASTRA PHARMA MEDOPRES METHYLDOPA 250MG COSMOS LIMITED..- KENYA ORAL SOLID 1.0X10.0X 7/1/1998
DP/4710 (U) LIMITED S TABLETS RANGWE ROAD, OFF ORDINARY 10.0
250MG LUNGA LUNGA ROAD, TABLETS TABLET
INDUSTRIAL AREA BLISTER,1.
0X1000.0
TABLET
CONTAIN
ER
2316 NDA/MAL/H AJANTA ABACUS MEFLAM MEFENAMIC 50MG/5ML AJANTA PHARMA LIMITED- INDIA ORAL LIQUID 1.0X1.0X1 7/1/2011
DP/4713 PHARMA LTD PHARMA ACID 31-0 MIDC INDUSTRIAL ORDINARY 00.0 ML
(AFRICA) AREA CHIKALTHANA SUSPENSION BOTTLE
AURANGABAD
MAHARASHTRA STATE
2317 NDA/MAL/H PHARCO WIDE CEPHOXIN CEPHALEXIN 250MG/5 PHARCO EGYPT ORAL LIQUID 1.0X100.0 7/1/1998
DP/4714 PHARMACEUT SPECTRUM 250MG/5M ML PHARMACEUTICALS LTD- ORDINARY ML
ICALS ENTERPRISES L KILO 31 ALEXANDRIA, DRY BOTTLE
(U) LIMITED CAIRO DESERT ROAD, SUSPENSION
ARAB REPUBLIC OF EGYPT. S/SYRUPS/D
ALEXANDRIA EGYPT
2318 NDA/MAL/H BLUE CROSS STAR MEFTAL MEFENAMIC 500MG + BLUE CROSS INDIA ORAL SOLID 1.0X5.0X2 7/1/2008
DP/4715 LABARATORIE PHARMACEUTIC FORTE ACID + 450MG LABORATORIES LTD-L-17, ORDINARY .0X10.0
S LIMITED ALS LTD PARACETAM VERNA INDUSTRIAL TABLETS TABLET
OL ESTATE,VERNA GOA- BLISTER
403722
2319 NDA/MAL/H BLUE CROSS STAR MEFTAL- MEFENAMIC 250MG + BLUE CROSS INDIA ORAL SOLID 1.0X10.0X 7/1/2008
DP/4717 LABARATORIE PHARMACEUTIC SPAS ACID + 10MG LABORATORIES LTD-L-17, ORDINARY 20.0
S LIMITED ALS LTD DICYCLOMINE VERNA INDUSTRIAL TABLETS TABLET
HYDROCHLOR ESTATE,VERNA GOA- BLISTER
IDE 403722
2320 NDA/MAL/H MEGA ABACUS ACNOTIN ISOTRETINOI 20MG MEGA LIFE SCIENCES THAILAND ORAL SOLID 1.0X3.0X1 7/1/2011
DP/4718 LIFESCIENCES PHARMA 20 N PUBLIC COMPANY ORDINARY 0.0
(AUSTRALIA) (AFRICA) LIMITED-384 SOIB OTHER CAPSULE
PTY LTD LIMITED PATTANA 3 RD BANGPOO CAPSULES BLISTER
INDUSTRIAL ESTATE
SAMUTPRAKARN 10280
2321 NDA/MAL/H MEGA ABACUS ACNOTIN ISOTRETINOI 10MG MEGA LIFE SCIENCES THAILAND ORAL SOLID 1.0X3.0X1 7/1/2011
DP/4719 LIFESCIENCES PHARMA 10 N PUBLIC COMPANY ORDINARY 0.0
(AUSTRALIA) (AFRICA) LIMITED-384 SOIB OTHER CAPSULE
INDUSTRIAL ESTATE
SAMUTPRAKARN 10280
2322 NDA/MAL/H SQUARE GAMA CEFTRON CEFTRIAXONE 1G SQUARE BANGLADESH PARENTERAL 1.0X1.0 G 7/1/2011
DP/4720 CEPHALOSPO PHARMACEUTIC PHARMACEUTICALS ORDINARY VIAL +
RINS LTD ALS (U) LIMITED LIMITED--DHAKA UNIT DRY VIALS 1*10 ML
KALIAKOIR GAZIPUR – AMPOULE
1750, BANGLADESH WATER
FOR
INJECTIO
N
2323 NDA/MAL/H PT SAMBE MEDVIN MEGABAL MECOBALAMI 5000MCG PT SANBE FARMA,UNIT 1- INDONESIA ORAL SOLID 1.0X10.0X 7/1/2011
DP/4721 FARMA PHARMA N JI INDUSTRI NO.9 ORDINARY 10.0
LIMITED LEUWIGAJAH CIMINDI OTHER CAPSULE
CIMAHI WEST CAPSULES STRIP
JAVA,INDONESIA
2324 NDA/MAL/H REGAL REGAL PHARMA MEGYL METRONIDAZ 200MG/5 REGAL KENYA ORAL LIQUID 1.0X100.0 7/1/1997
DP/4723 PHARMACEUI (U) LTD SUSPENSIO OLE ML PHARMACEUTICALS LTD- ORDINARY ML
CALS LTD N BENZOATE BABA DOGO ROAD, SUSPENSION BOTTLE
RAURAKA,NAIROBI,KENYA S
2325 NDA/MAL/H GLAXOSMITH UNITED ACTIFED TRIPROLIDINE 1.25MG+3 GLAXOSMITHKLINE SAE ,.- EGYPT ORAL LIQUID 1.0X100.0 7/1/1997
DP/4724 KLINE LTD HEALTHCARE DRY HYDROCHLOR 0MG+10M EL SALAM CITY-11491, ORDINARY ML
DISTRIBUTORS COUGH & IDE+PSEUDOE G CAIRO SYRUPS BOTTLE,1.
LTD COLD PHEDRINE 0X60.0 ML
HYDROCHLOR BOTTLE,1.
IDE+DEXTRO 0X2.0 L
METHORPHA BOTTLE
N
2326 NDA/MAL/H REGAL REGAL PHARMA MEGYL METRONIDAZ 200MG REGAL KENYA ORAL SOLID 1.0X10.0X 7/1/1997
DP/4725 PHARMACEUT (U) LTD TABLET OLE PHARMACEUTICALS LTD- ORDINARY 10.0
0X250.0
TABLET
CONTAIN
ER,1.0X10
00.0
TABLET
CONTAIN
ER
2327 NDA/MAL/H MACK SHURIK LTD ADB MIN MULTI- MULTI- TORQUE INDIA ORAL LIQUID 1.0X100.0 7/1/1997
DP/4726 BROWN MULTIPOW INGREDIENT INGREDIEN PHARMACEUTICALS LTD - ORDINARY ML
PHARMACEUT ER T ISSAPUR P.O DAPPAR SYRUPS BOTTLE,1.
ICALS PVT 140506 0X300.0
LIMITED ML
BOTTLE
2328 NDA/MAL/H M.J.BIOPHAR TATA UGANDA ADRENALIN ADRENALINE IMG/ML M.J BIOPHARM PVT LTD- INDIA PARENTERAL 1.0X10.0X 7/1/2014
DP/4728 M PVT LTD LIMITED E TALOJA DISTRICT RAIGAD ORDINARY 10.0 ML
410208 NAVI MUMBAI AMPOULES AMPOULE
2329 NDA/MAL/H SANOFI LABOREX MENACTRA MENINGOCO 4MCG + SANOFI PASTEUR-INC UNITED PARENTERAL 1.0X5.0 7/1/2011
DP/4730 PASTEUR UGANDA CCAL GROUPS 4MCG + DISCOVERY DRIVE STATES ORDINARY I ML VIAL
LIMITED (A + C +Y + W- 4MCG + SWIFTWATER M VIALS (10 DOSE
135) + 4MCG + PENNSYLVANIA 183370- VIAL)
POLYSACCHA 48MCG 0187
RIDE
DIPTHERIA
TOXOID
CONJUGATE
VACCINE
2330 NDA/MAL/H SERUM NORVIK MENAFRIV MENINGOCO 10MCG/ SERUM INSTITUTE OF INDIA PARENTERAL 1.0X1.0X1 7/1/2011
DP/4731 INSTITUTE OF ENTERPRISES AC CCAL A 0.5ML + 10- INDIA LTD-212/2 ORDINARY 0.0 DOSE
INDIA LTD. LIMITED CONJUGATE 33MCG/0.5 HADAPSAR, PUNE, 411028, DRY VIALS VIAL +
VACCINE ML INDIA 1*5ML
AMPOULE
OF
DILUENT
2331 NDA/MAL/H MENTHOLAT HARLEYS MENTHOLA MULTI- MULTI- THE MENTHOLATUM UNITED TOPICAL 1.0X30.0 7/1/1997
DP/4735 UM UGANDA TUM BALM INGREDIENT INGREDIEN COMPANY LTD- TWYFORD, KINGDOM EXTERNAL G
LIMITED T BENKSHIRE, E OINTMENTS TUBE,1.0X
4.0 G
TUBE
2332 NDA/MAL/H CIRON DRUGS RENE CICOL DICYCLOMINE 10MG + CIRON DRUGS & INDIA ORAL LIQUID 1.0X10.0 7/1/2014
DP/4737 AND PHARMACY LTD DROPS HYDROCHLOR 40MG/ PHARMACEUTICALS PVT ORDINARY ML
PHARMACEUT IDE + 5ML LTD-N-118, N-119 MIDC DROPS BOTTLE
ICALS PVT LTD SIMETICONE TARAPUR BOISAR DIST
THANE 401506
MAHARASHTRA INDIA
2333 NDA/MAL/H NORVATIS LABOREX CILOXAN CIPROFLOXAC 0.3%W/V ALCON -ALCON BELGIUM OPHTHALMI 1.0X5.0 7/1/1997
DP/4738 PHARMA AG- UGANDA IN COUVREUR NV B-2870 C DROPS ML
D
2334 NDA/MAL/H SWISS SHREEJI MERO MEROPENEM 1G SWISS PARENTERALS LTD- INDIA PARENTERAL 1.0X1.0 G 7/1/2011
DP/4739 PARENTERALS PHARMACEUTIC 809 KERALA IND ESTATE ORDINARY VIAL
AHMEDABAD 382220
GUJARAT INDIA
2335 NDA/MAL/H DAFRA LABOREX MERONIA MEROPENEM 1000MG DEMO SA-21ST KM GREECE PARENTERAL 1.0X1000. 7/1/2013
DP/4743 PHARMA UGANDA 1000 NATIONAL ROAD, ATHENS, ORDINARY 0 MG VIAL
N.V/S.A LIMITED LAMIA 14568 KRYONERI, VIALS
ATHENS
2336 NDA/MAL/H DAFRA LABOREX MERONIA MEROPENEM 500MG DEMO SA-21ST KM GREECE PARENTERAL 1.0X500.0 7/1/2013
DP/4744 PHARMA UGANDA 500 NATIONAL ROAD, ATHENS, ORDINARY MG VIAL
N.V/S.A LIMITED LAMIA 14568 KRYONERI, DRY VIALS
ATHENS
2337 NDA/MAL/H RIVA WIDE ZITHRORIV AZITHROMYCI 200MG/5 RIVA PHARMA FREE ZONE- EGYPT ORAL LIQUID 1.0X22.5 7/1/2011
DP/4747 PHARMA SPECTRUM N ML NASR CITY CAIRO EGYPT ORDINARY ML
FREE ZONE ENTERPRISES DRY BOTTLE
(U) LIMITED SUSPENSION
S/SYRUPS/D
ROPS
2338 NDA/MAL/H MEDICAL KARURI ACICONE-S MAGALDRATE 720MG+25 MEDICAL UNION PHARMA EGYPT ORAL SOLID 1.0X5.0X4 7/1/2006
DP/4748 UNION PHARMACEUTIC CHEWABLE +SIMETHICON MG .CO-ABU-SULTAN ISMAILIA ORDINARY .0 TABLET
PHARMACEUT ALS LTD. TABLET E EGYPT CHEWABLE BLISTER
ICALS TABLETS
2339 NDA/MAL/H PT SANBE MEDVIN MEROSAN MEROPENEM 1G PT SANBE FARMA-JI INDONESIA PARENTERAL 1.0X1.0 G 7/1/2012
DP/4749 FARMA PHARMA LEUWIGAJAH I62 CIMINDI ORDINARY VIAL
INDONESIA
2340 NDA/MAL/H GITTOES GITTOES FEROL FERROUS 200MG AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1.0X1000. 7/1/2009
DP/4751 PHARMACEUT PHARMACEUTIC SULPHATE NO.33,SECTOR ORDINARY 0 TABLET
ICALS LIMITED ALS LIMITED II,VASAI,TALUKA INDL CO- COATED CONTAIN
OP ESTATE LTD,GAURAI TABLETS ER,1.0X10
E INDIA TABLET
BLISTER,1.
0X100.0X1
0.0
TABLET
BLISTER
2341 NDA/MAL/H ERIS LTD BENLE CONSULT METFORMI METFORMIN 500MG DENK PHARMA GMBH GERMANY ORAL SOLID 1.0X10.0X 7/1/1998
DP/4757 LIMITED N-DENK &CO.KG-- ORDINARY 10.0
500 PRINZREGENTESTR.79.816 FILM- TABLET
75 MUENCHEN, COATED BLISTER,1.
GERMANY BLISTER,1.
0X3.0X10.
0 TABLET
BLISTER
2342 NDA/MAL/H DENK BENLE CONSULT METFORMI METFORMIN 1000MG DENK PHARMA GMBH GERMANY ORAL SOLID 1.0X2.0X1 7/1/2011
DP/4758 PHARMA LIMITED N DENK &CO.KG-- ORDINARY 5.0
GMB H &CO. 1000 PRINZREGENTESTR.79.816 FILM- TABLET
KG 75 MUENCHEN, COATED BLISTER
GERMANY, GOLLSTR, 1-D- TABLETS
845529 TITTMONING
GERMANY
2343 NDA/MAL/H DAR AL DAWA GAMA CIPRODAR CIPROFLOXAC 500MG DAR AL DAWA-DAR AL JORDAN ORAL SOLID 1.0X10.0 7/1/2009
DP/4759 DEVELOPMEN PHARMACEUTIC IN DAWA DEVELOPMENT ORDINARY TABLET
T AND ALS (U) LIMITED AND INVESTMENT CO LTD. TABLETS BLISTER
AMMAN, JORDAN
2344 NDA/MAL/H HILTON HEALTHCARE FEROSOFT IRON (III) 50MG/5ML HILTON PHARMA (PVT) PAKISTAN ORAL LIQUID 1.0X120.0 7/1/2005
DP/4760 PHARMA LTD. HYDROXIDE LTD-PLOT 13, SECTOR 15, ORDINARY ML
(PVT) LTD POLYMALTOS KORANGI INDUSTRIAL SYRUPS BOTTLE
E COMPLEX AREA,KARACHI, PAKISTAN.
2345 NDA/MAL/H HILTON HEALTHCARE FEROSOFT- IRON(III)HYD 100MG/0.3 HILTON PHARMA (PVT) PAKISTAN ORAL SOLID 1.0X2.0X1 7/1/2005
DP/4765 PHARMA LTD. FA ROXIDE 5MG LTD-PLOT 13 SECTOR 15 ORDINARY 0.0
(PVT) LTD POLYMALTOS KORANGI INDUSTRIAL TABLETS TABLET
E AREA KARACHI BLISTER
COMPLEX/FO
LIC ACID
2346 NDA/MAL/H GITTOES GITTOES AGOBEN MEBENDAZOL 100MG/5 AGOG PHARMA LTD-PLOT INDIA ORAL LIQUID 1.0X30.0 7/1/2001
DP/4766 PHARMACEUT PHARMACEUTIC SUSPENSIO E ML NO.33,SECTOR ORDINARY ML
ICALS LIMITED ALS LIMITED N II,VASAI,TALUKA INDL CO- SUSPENSION BOTTLE
OP ESTATE LTD,GAURAI S
E INDIA
2347 NDA/MAL/H GITTOES GITTOES AGOBEX MEBENDAZOL 100MG AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1.0X1000. 7/1/2009
DP/4769 PHARMACEUT PHARMACEUTIC E NO.33,SECTOR ORDINARY 0 TABLET
ICALS LIMITED ALS LIMITED II,VASAI,TALUKA INDL CO- CHEWABLE CONTAIN
E INDIA TABLET
BLISTER,1.
0X100.0X1
0.0
TABLET
BLISTER
2348 NDA/MAL/H EGYPTIAN WIDE FERROFOL FERROUS 150MG+0. EGYPTIAN EGYPT ORAL SOLID 1.0X5.0X6 7/1/2014
DP/4774 INTERNATION SPECTRUM VIT-Z SULPHATE+F 5MG+50M INTERNATIONAL ORDINARY .0
AL ENTERPRISES OLIC G+2MG+2 PHARMACEUTICAL CAPSULES CAPSULE
PHARMACEUT (U) LIMITED ACID+ASCORB MG+1MG+ INDUSTRIES COMPANY- BLISTER
ICAL IC 10MG+25 10TH OF RAMADAN CITY
INDUSTRIES ACID+THIAMI MG FIRST INDUSTRIAL AREA
COMPANY NE
MONONITRA
TE+RIBOTLAV
INE+PYRIDOX
INE
HCL+NICOTIN
2349 NDA/MAL/H SKAGE ABACUS CIPROKANT- CIPROFLOXAC 500MG S KANT HEALTH CARE LTD- INDIA ORAL SOLID 1.0X10.0X 7/1/2010
DP/4775 EXPORTS PHARMA 500 IN PLOT 1802 – 1805 ORDINARY 10.0
(AFRICA) FILM- TABLET
TABLETS
2350 NDA/MAL/H PHARCO WIDE CURISAFE CEFADROXIL 125MG/5 PHARCO EGYPT ORAL LIQUID 1.0X60.0 7/1/2000
DP/4778 PHARMACEUT SPECTRUM MONOHYDRA ML PHARMACEUTICALS LTD- ORDINARY ML
ICALS ENTERPRISES TE KILO 31 ALEXANDRIA, DRY BOTTLE
ALEXANDRIA EGYPT
2351 NDA/MAL/H VHB MEDI LLOYDS CYBIN PF CYTARABINE 100MG/ML VHB MEDI SCIENCES LTD- INDIA PARENTERAL 1.0X2.0 7/1/2013
DP/4782 SCIENCES LTD PHARMACY PLOT 20, 21, 22 & 49,50, ORDINARY ML
LIMITED 51. INTEGRATED AMPOULES AMPOULE
5, RUDRAPUR,
UTTARAKHAND - INDIA
DP/4784 PARENTERAL PARENTERAL INTRAVENOU DRUGS LIMITED-BLOCK ORDINARY ML
DRUGS DRUGS LIMITED S INFUSION 191, PLOT NO. 114, INFUSION BOTTLE
LIMITED GWAWANYA KINGA AND VIALS/BOTTL
KAPEKA MUKONO ES
DISTRICT, UGANDA.
2353 NDA/MAL/H JASSEN-CILAG LABOREX DAKTACOR MICONAZOLE 2%W/W+1 SPECPHARM HOLDINGS- SOUTH TOPICAL 1.0X15.0 7/1/1997
DP/4785 (PTY) LTD UGANDA T NITRATE+HYD %W/W 15TH ROAD HALFWAY AFRICA EXTERNAL G TUBE
LIMITED ROCORTISON HOUSE CREAMS
E
2354 NDA/MAL/H MISSION JOINT MEDICAL COTRIMOX SULPHAMETH 800MG + MEDICAMEN BIOTECH LTD- INDIA ORAL SOLID 1.0X1000. 7/1/2009
DP/4786 PHARMA A/S STORE (UPMB - AZOLE OXAZOLE + 160MG SP-1192, A &B, PHASE –IV, ORDINARY 0 TABLET
UCMB) 960MG TRIMETHOPRI INDUSTRIAL AREA TABLETS CONTAIN
M BHIWADI -301019 DIST. ER
ALWAR (RAJASTHAN)
2355 NDA/MAL/H JASSEN-CILAG LABOREX DAKTARIN MICONAZOLE 20MG/G SPECPHARM HOLDINGS- SOUTH TOPICAL 1.0X20.0 7/1/1997
DP/4787 (PTY) LTD UGANDA NITRATE 15TH ROAD HALFWAY AFRICA EXTERNAL G TUBE
LIMITED HOUSE CREAMS
2356 NDA/MAL/H JASSEN-CILAG LABOREX DAKTARIN MICONAZOLE 20MG/G SPECPHARM HOLDINGS- SOUTH ORAL 1.0X40.0 7/1/1997
DP/4788 (PTY) LTD UGANDA ORAL GEL NITRATE 15TH ROAD HALFWAY AFRICA TOPICAL G TUBE
LIMITED HOUSE GELS AND
SOLS
2357 NDA/MAL/H PFIZER LABOREX DALACIN C CLINDAMYCI 300MG FAREVA AMBOISE - -ZONE FRANCE ORAL SOLID 1.0X100.0 7/1/1997
DP/4789 LABORATORIE UGANDA N INDUSTRIELLE, 29 ROUTE ORDINARY CAPSULE
S PTY LTD LIMITED HYDROCHLOR DES INDUSTRIES, 37530 CAPSULES CARTON,1
IDE POCE SUR CISSE, FRANCE .0X2.0X8.
0
CAPSULE
STRIP
2358 NDA/MAL/H PFIZER LABOREX DALACIN C CLINDAMYCI 150MG FAREVA AMBOISE - -ZONE BELGIUM ORAL SOLID 1.0X2.0X8 7/1/1997
DP/4790 LABORATORIE UGANDA N INDUSTRIELLE, 29 ROUTE ORDINARY .0
S (PTY) LTD LIMITED HYDROCHLOR DES INDUSTRIES, 37530 CAPSULES CAPSULE
IDE POCE SUR CISSE, FRANCE STRIP,1.0X
100.0
CAPSULE
CARTON
2359 NDA/MAL/H PFIZER LABOREX DALACIN C CLINDAMYCI 75MG/5ML PHARMACIA AND UPJOHN BELGIUM ORAL LIQUID 1.0X80.0 7/1/1997
DP/4791 LABORATORIE UGANDA N PALMITATE S.P.A-RIJKSWEG 12, B- ORDINARY ML
S (PTY) LTD LIMITED 2870 PUURS OTHER BOTTLE
POWDERS/G
RANULES
2360 NDA/MAL/H PFIZER LABOREX DALACIN C CLINDAMYCI 150MG/ML PFIZER GLOBAL BELGIUM PARENTERAL 1.0X4.0 7/1/1997
DP/4792 LABORATORIE UGANDA N MANUFACTURING ORDINARY ML
S (PTY) LTD LIMITED PHOSPHATE BELGIUM NV-RIJKSWEG VIALS VIAL,1.0X
12, 2870 PUURS - 2.0 ML
BELGIUM VIAL
2361 NDA/MAL/H PFIZER LABOREX DALACIN T CLINDAMYCI 1%W/V PHARMACIA AND UPJOHN BELGIUM TOPICAL 1.0X30.0 7/1/1997
DP/4793 LABORATORIE UGANDA N S.P.A-RIJKSWEG 12, B- EXTERNAL ML
S (PTY) LTD LIMITED PHOSPHATE 2870 PUURS LIQUIDS BOTTLE
2362 NDA/MAL/H SHOSAAN RENE DALADOL DICLOFENAC 50MG+500 NEM LABORATORIES PVT INDIA ORAL SOLID 1.0X10.0X 7/1/2012
DP/4794 ASIC PACIFIC PHARMACY LTD SODIUM + MG LTD-133 KRISHNA ORDINARY 10.0
PARACETAM INDUSTRIAL ESTATE VASAI TABLETS TABLET
OL (E) DIST THANE 401 210 BLISTER
MAHARASHTRA
2363 NDA/MAL/H DAR AL DAWA GAMA DAROXIME CEFUROXIME 500MG DAR AL DAWA-DAR AL JORDAN ORAL SOLID 1.0X10.0 7/1/2010
DP/4795 DEVELOPMEN PHARMACEUTIC DAWA DEVELOPMENT ORDINARY TABLET
T AND ALS (U) LIMITED AND INVESTMENT CO LTD. TABLETS BOTTLE
AMMAN, JORDAN
2364 NDA/MAL/H ABACUS ABACUS DARROWS POTASSIUM 0.13%+0.2 ABACUS PARENTERAL UGANDA PARENTERAL 1.0X500.0 7/1/2011
DP/4796 PARENTERAL PARENTERAL SOLUTION CHLORIDE+SO 0%+0.30% DRUGS LTD-PLOT NO. 114, ORDINARY ML
DRUGS DRUGS LIMITED (HALF DIUM BLOCK 191, GWAGAMYA, INFUSION BOTTLE
LIMITED STRENGTH) CHLORIDE+SO KINGA, KAPEKE, VIALS/BOTTL
DIUM MUKONO ES
LACTATE
2365 NDA/MAL/H VENUS AARON CITABOL GEMCITABIN 2MG/ML VENUS REMEDIES LTD, INDIA PARENTERAL 1.0X50.0 7/1/2009
DP/4798 REMIDIES LTD PHARMACEUTIC E UNIT II,-HILL TOP ORDINARY ML VIAL
ALS LTD INDUSTRIAL ESTATE, VIALS
KALAN, BADDI -HP
2366 NDA/MAL/H PHARCO WIDE CITROLIN CETRIMIDE+LI 25MG+3M PHARCO EGYPT ORAL 1.0X120.0 7/1/1998
DP/4799 PHARMACEUT SPECTRUM SOLUTION DOCAINE G PHARMACEUTICALS LTD- TOPICAL ML
ICALS ENTERPRISES KILO 31 ALEXANDRIA, LIQUIDS BOTTLE
ALEXANDRIA EGYPT
2367 NDA/MAL/H DAWA SUPER MEDIC DAWAVITE MULTI- MULTI- DAWA LTD -PLOT KENYA ORAL LIQUID 1.0X100.0 7/1/2009
DP/4800 LIMITED LTD SYRUP INGREDIENT INGREDIEN NO.7879/8 BABA ROAD ORDINARY ML
T RUARAKA NAIROBI SYRUPS BOTTLE,1.
0X60.0 ML
BOTTLE
2368 NDA/MAL/H AJANTA ABACUS DAZEL KIT FLUCONAZOL 150MG + AJANTA PHARMA LIMITED INDIA ORAL SOLID 1.0X1.0X4 7/1/2009
DP/4801 PHARMA LTD PHARMA E+ 1G + 1G PAITHAN- ORDINARY .0 TABLET
(AFRICA) AZITHROMYCI MANUFACTURING UNIT B- FILM- BLISTER
LIMITED N+ 4/5/6 MIDC PAITHAN COATED
SECNIDAZOLE DISTRICT AURANGABAD TABLETS
431 148 MAHARASTRA
STATE INDIA
2369 NDA/MAL/H DAR AL DAWA GAMA CLAVODAR AMOXICILLIN 200MG + DAR AL DAWA-NA'UR JORDAN ORAL LIQUID 1.0X70.0 7/1/2012
DP/4804 DEVELOPMEN PHARMACEUTIC + 28MG PLANT AMMAN ORDINARY ML
T AND ALS (U) LIMITED CLAVULANIC /5ML DRY BOTTLE
INVESTMENT SUSPENSION
CO LTD S/SYRUPS/D
ROPS
2370 NDA/MAL/H GITTOES GITTOES AGOFEN IBUPROFEN 200MG AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 10.0X10.0 7/1/2000
DP/4805 PHARMACEUT PHARMACEUTIC NO.33,SECTOR ORDINARY TABLET
ICALS LIMITED ALS LIMITED II,VASAI,TALUKA INDL CO- FILM- BLISTER,1.
OP ESTATE LTD,GAURAI COATED 0X1000.0
PADA,VASAI(E)DIST.THAN TABLETS TABLET
E INDIA CONTAIN
ER
2371 NDA/MAL/H GITTOES GITTOES AGOFER FERROUS 200MG + AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1.0X1000. 7/1/2009
DP/4806 PHARMACEUT PHARMACEUTIC SULPHATE+F 0.25MG NO.33,SECTOR ORDINARY 0 TABLET
ICALS LIMITED ALS LIMITED OLIC ACID II,VASAI,TALUKA INDL CO- COATED CONTAIN
E INDIA TABLET
BLISTER,1.
0X10.0X10
.0 TABLET
BLISTER
2372 NDA/MAL/H GITTOES GITTOES AGOFORMI METFORMIN 500MG AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1.0X10.0X 7/1/2011
DP/4807 PHARMACEUT PHARMACEUTIC N NO.33,SECTOR ORDINARY 10.0
E INDIA TABLET
CONTAIN
ER
2373 NDA/MAL/H GITTOES GITTOES AGOCORT HYDROCORTI 0.1%W/W AGOG PHARMA LTD-PLOT INDIA TOPICAL 1.0X15.0 7/1/2013
DP/4809 PHARMACEUT PHARMACEUTIC SKIN SONE NO.33,SECTOR EXTERNAL G TUBE
ICALS LIMITED ALS LIMITED CREAM II,VASAI,TALUKA INDL CO- CREAMS
E INDIA
2374 NDA/MAL/H GITTOES GITTOES AGOGYL METRONIDAZ 200MG AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1.0X1000. 7/1/2009
DP/4811 PHARMACEUT PHARMACEUTIC OLE NO.33,SECTOR ORDINARY 0 TABLET
E INDIA TABLET
BLISTER,1.
0X100.0X1
0.0
TABLET
BLISTER
2375 NDA/MAL/H GITTOES GITTOES AGOMETRO METRONIDAZ 125MG/5 AGOG PHARMA LTD-PLOT INDIA ORAL LIQUID 1.0X100.0 7/1/2001
DP/4812 PHARMACEUT PHARMACEUTIC L OLE ML NO.33,SECTOR ORDINARY ML
ICALS LIMITED ALS LIMITED SUSPENSIO BENZOATE II,VASAI,TALUKA INDL CO- SUSPENSION BOTTLE
E INDIA
2376 NDA/MAL/H GITTOES GITTOES AGOMETRO METRONIDAZ 200MG AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1.0X500.0 7/1/1998
DP/4813 PHARMACEUT PHARMACEUTIC L TABLETS OLE NO.33,SECTOR ORDINARY TABLET
ICALS LIMITED ALS LIMITED (THANE) II,VASAI,TALUKA INDL CO- TABLETS CONTAIN
PADA,VASAI(E)DIST.THAN 0.0
E INDIA TABLET
CONTAIN
ER,1.0X10
00.0
TABLET
CONTAIN
ER,10.0X1
2377 NDA/MAL/H I-CARE AIVEEN (U) METLIFE METRONIDAZ 500MG/10 EUROLIFE HEALTHCARE INDIA PARENTERAL 1.0X100.0 7/1/2010
DP/4814 PHARMA LTD LIMITED OLE 0ML PVT LTD-BHAGWANPUR ORDINARY ML
ROAD, UTTARAKHAND INFUSION BOTTLE
VIALS/BOTTL
ES
2378 NDA/MAL/H LABORATORY HARLEYS FERROLIC- FERROUS 200MG+0. LABORATORY & ALLIED KENYA ORAL SOLID 1.0X1000. 7/1/2014
DP/4815 AND ALLIED UGANDA LF SULPHATE 4MG LTD-PLOT NO. 209/10349 ORDINARY 0 TABLET
LTD LIMITED +FOLIC ACID OFF MOMBASA ROAD, TABLETS CONTAIN
NAIROBI ER,1.0X10
P.O. BOX 42875, NAIROBI, .0X10.0
KENYA. TABLET
BLISTER
2379 NDA/MAL/H LABORATORY HARLEYS FERROUS FERROUS 200MG LABORATORY & ALLIED KENYA ORAL SOLID 1.0X1000. 7/1/1997
DP/4818 AND ALLIED UGANDA SULPHATE SULPHATE LTD-PLOT NO. 209/10349 ORDINARY 0 TABLET
LTD LIMITED OFF MOMBASA ROAD, TABLETS CONTAIN
NAIROBI ER,1.0X10
KENYA. TABLET
BLISTER
2380 NDA/MAL/H EMCURE HARLEYS METPURE- METOPROLOL 50MG EMCURE INDIA ORAL SOLID 1.0X3.0X1 7/1/2009
DP/4821 PHARMACEUT UGANDA XL 50 PHARMACEUTICALS ORDINARY 0.0
ICALS LTD LIMITED LIMITED -LANE NO.3 FILM- TABLET
PHASE II SIDCO COATED BLISTER
INDUSTRIAL COMPLEX TABLETS
BARI-BRAHMANA JAMMU
,181133
2381 NDA/MAL/H OTSUKA REDDYS METRIS METRONIDAZ 5MG/ML OTSUKA INDIA PARENTERAL 1.0X100.0 7/1/1997
DP/4823 PHARMACEUT PHARMA INFUSION OLE PHARMACEUTICAL INDIA ORDINARY ML
ICAL INDIA LIMITED PRIVATE LTD-VILLAGE – INFUSION BOTTLE
PRIVATE VASANA – VIALS/BOTTL
LIMITED CHACHARWADIP, TAL: ES
SANAND, AHMADABAD
2382 NDA/MAL/H MISSION JOINT MEDICAL FERROUS FERROUS 200MG+0. BIO NOVA PHARM LTD.-C- INDIA ORAL SOLID 1.0X1000. 7/1/2008
DP/4824 PHARMA A/S STORE (UPMB - SULPHATE+ SULPHATE+F 25MG 66/1 OKHLA INDUSTIAL ORDINARY 0 TABLET
UCMB) FOLIC ACID OLIC ACID AREA PHASE II NEW DEHLI COATED CONTAIN
TABLETS ER
2383 NDA/MAL/H UNIQUE TATA UGANDA METROGYL METRONIDAZ 1%W/W + UNIQUE INDIA ORAL 1.0X20.0 7/1/2004
DP/4826 PHARMACEUT LIMITED DENTA GEL OLE + 0.25%W/W PHARMACEUTICAL TOPICAL G TUBE
ICALS LTD CHLORHEXIDI LABORATORIES (A DIV. OF GELS AND
NE J.B CHEMICALS & SOLS
PHARMACEUTICALS LTD)--
AREA PANOLI 394 116
DIST BHARUCH
2384 NDA/MAL/H UNIQUE TATA UGANDA METROGYL METRONIDAZ 1%W/W UNIQUE INDIA TOPICAL 1.0X30.0 7/1/2001
DP/4828 PHARMACEUT LIMITED GEL OLE PHARMACEUTICAL EXTERNAL G TUBE
ICALS LABORATORIES (A DIV. OF EMULSION (ALUMINI
LABORATORIE J.B CHEMICALS & GELS UM
S PHARMACEUTICALS LTD)-- TUBE),1.0
304-308 GIDC INDUSTRIAL X30.0 G
AREA PANOLI 394 116 TUBE
DIST BHARUCH (LAMINAT
ED TUBE)
2385 NDA/MAL/H UNIQUE TATA UGANDA METROGYL METRONIDAZ 5MG/ML UNIQUE INDIA PARENTERAL 1.0X100.0 7/1/1997
DP/4830 PHARMACEUT LIMITED INJECTION OLE PHARMACEUTICAL ORDINARY ML
ICALS LABORATORIES, (A INFUSION BOTTLE
LABORATORIE DIVISION OF J.B VIALS/BOTTL
S CHEMICALS & ES
PLOT NO 4, PHASE IV,
GIDC INDUSTRIAL AREA,
PANOLI 394 116 UNIQUE
PHARMACEUTICAL
LABORATORIES (A DIV. OF
J.B CHEMICALS &
2386 NDA/MAL/H UNIQUE TATA UGANDA METROGYL METRONIDAZ 200MG/5 UNIQUE INDIA ORAL LIQUID 1.0X100.0 7/1/1997
DP/4832 PHARMACEUT LIMITED SUSPENSIO OLE ML PHARMACEUTICAL ORDINARY ML
ICALS N LABORATORIES-PLOT NO. SUSPENSION BOTTLE
LABORATORIE 215-219, G.I.D.C. S
S INDUSTRIAL AREA,PANOLI
— 394 116, GUJARAT,
INDIA.
J.B. CHEMICALS AND
PHARMACEUTICALS LTD .-
128/1, GIDC,
ANKLESHWAR 393 002,
GUJARAT
2387 NDA/MAL/H AUROBINDO GITTOES FINAGEN FINASTERIDE 5MG AUROBINDO PHARMA LTD- INDIA ORAL SOLID 1.0X2.0X1 7/1/2004
DP/4834 PHARMA LTD PHARMACEUTIC UNIT III-SURVEY ORDINARY 0.0
ALS LIMITED NO.313,BACHUPALLY FILM- TABLET
VILLAGE,QUTHUBULLAPU COATED BLISTER
R MANDAL R.R TABLETS
DISTRICT(A.P),INDIA
2388 NDA/MAL/H GITTOES GITTOES METRON METRONIDAZ 200MG AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1.0X10.0X 7/1/2009
DP/4836 PHARMACEUT PHARMACEUTIC OLE NO.33,SECTOR ORDINARY 10.0
E INDIA 0.0
TABLET
BLISTER,1.
0X1000.0
TABLET
CONTAIN
ER
2389 NDA/MAL/H ABACUS ABACUS METRONID METRONIDAZ 125MG/5 MEDICAMEN BIOTECH LTD- INDIA ORAL LIQUID 1.0X100.0 7/1/2014
DP/4838 PHARMA LTD PHARMA AZOLE OLE ML SP-1192, A &B, PHASE –IV, ORDINARY ML
(AFRICA) BENZOATE INDUSTRIAL AREA SUSPENSION BOTTLE
LIMITED BHIWADI -301019 DIST. S
ALWAR (RAJASTHAN)
2390 NDA/MAL/H TORRENT KARURI ANTIDEP IMIPRAMINE 25MG TORRENT INDIA ORAL SOLID 10.0X10.0 7/1/1997
DP/4845 PHARMACEUT PHARMACEUTIC PHARMACEUTICALS LTD- ORDINARY TABLET
ICALS LTD ALS LTD. INDRAD-382 721, TABLETS BLISTER,1.
DIST.MEHSANA,INDIA.AT: 0X1000.0
VILL.MANAKPUR,TEH.NAL TABLET
AGARH,DIST.SOLAN(H.P.) CONTAIN
ER
2391 NDA/MAL/H SHAIGAN HEALTHCARE CLOZOX V CLOTRIMAZO 100MG SHAIGAN PAKISTAN VAGINAL 1.0X1.0X6 7/1/1997
DP/4851 PHARMACEUT LTD. LE PHARMACEUTICALS (PVT) TABLETS .0 TABLET
ICALS LTD LTD-14TH KM, ADYALA BLISTER
ROAD, RAWALPINDI-
PAKISTAN
2392 NDA/MAL/H RENE RENE METROREN METRONIDAZ 200MG RENE INDUSTRIES LTD- UGANDA ORAL SOLID 1.0X1000. 7/1/2014
DP/4854 INDUSTRIES INDUSTRIES FC OLE PLOT 680, KAMULI ROAD, ORDINARY 0 TABLET
LIMITED LIMITED KIREKA, P.O BOX 6034, FILM- CONTAIN
KAMPALA COATED ER
TABLETS
2393 NDA/MAL/H GLENMARK STAR ASCORIL SALBUTAMOL (2MG + GLENMARK INDIA ORAL LIQUID 1.0X200.0 7/1/2000
DP/4855 PHARMACEUT PHARMACEUTIC EXPECTORA SULPHATE + 4MG + PHARMACEUTICALS LTD- ORDINARY ML
ICALS LTD ALS LTD NT BROMHEXINE 100MG + PLOT NO E -37, 39 ,D SYRUPS BOTTLE,1.
HYDROCHLOR 1MG)/10M 0X100.0
IDE + L ML
GUAIFENESIN BOTTLE
+ MENTHOL
2394 NDA/MAL/H RENE RENE METROREN METRONIDAZ 200MG RENE INDUSTRIES LTD- UGANDA ORAL SOLID 1.0X10.0X 7/1/2001
DP/4856 INDUSTRIES INDUSTRIES OLE PLOT 680, KAMULI ROAD, ORDINARY 10.0
LIMITED LIMITED KIREKA, P.O BOX 6034, TABLETS TABLET
KAMPALA BLISTER,1.
0X20.0X10
.0 TABLET
BLISTER,1.
0X1000.0
TABLET
CONTAIN
ER
2395 NDA/MAL/H RENE RENE METROREN METRONIDAZ 200MG/5 RENE INDUSTRIES LTD- UGANDA ORAL LIQUID 1.0X100.0 7/1/2001
DP/4858 INDUSTRIES INDUSTRIES SUSPENSIO OLE ML PLOT 680, KAMULI ROAD, ORDINARY ML
LIMITED N BENZOATE KIREKA, P.O BOX 6034, SUSPENSION BOTTLE
KAMPALA S
2396 NDA/MAL/H GLAXOSMITH UNITED FLOXAPEN FLUCLOXACIL 250MG SMITHLINE BEECHAM UNITED ORAL SOLID 1.0X100.0 7/1/1997
DP/4859 KLINE HEALTHCARE LIN CLARENDON RD WORTHIN- KINGDOM ORDINARY CAPSULE
PHARMACEUT DISTRIBUTORS CLARENDON RD CAPSULES CARTON
ICAL KENYA LTD WORTHING WEST SUSSEX
LTD
2397 NDA/MAL/H MEDICAL KARURI MICONAZ MICONAZOLE 2%W/W MEDICAL UNION PHARMA EGYPT ORAL 1.0X20.0 7/1/2003
DP/4863 UNION PHARMACEUTIC ORAL GEL .CO-ABU-SULTAN ISMAILIA TOPICAL G TUBE
PHARMACUIT ALS LTD. EGYPT GELS AND
ICALS SOLS
2398 NDA/MAL/H MEDICAL KARURI MICONAZ MICONAZOLE 2%W/W MEDICAL UNION PHARMA EGYPT VAGINAL 1.0X20.0 7/1/2003
DP/4865 UNION PHARMACEUTIC CREAM NITRATE .CO-ABU-SULTAN ISMAILIA CREAMS G TUBE
PHARMACUIT ALS LTD. EGYPT
ICALS
2399 NDA/MAL/H CENTAUR GITTOES MICONA MICONAZOLE 20MG CENTAUR INDIA ORAL 1.0X40.0 7/1/2003
DP/4867 PHARMACEUT PHARMACEUTIC ORAL GEL PHARMACEUTICALS PVT TOPICAL G
ICALS PVT LTD ALS LIMITED LTD --PLANT II PLOT 39-41 GELS AND TUBE,1.0X
TIVIM INDUSTRIAL ESTATE SOLS 20.0 G
KARASWADA MAPUSA TUBE
GOA 403 526
2400 NDA/MAL/H NIRMA LIFE PHARMA FLUCANIR FLUCONAZOL 2MG/ML ACULIFE HEALTHCARE PVT INDIA PARENTERAL 1.0X100.0 7/1/2011
DP/4868 LIMITED AFRICA LIMITED E LTD-VILLAGE SACHANA, ORDINARY ML
(HEALTHCARE TALUKA, VIRAMGAM, INFUSION BOTTLE
DI VISION) DIST. AHMEDABAD VIALS/BOTTL
NIRLIFE 382150, GUJARAT ES
HEALTHCARE
2401 NDA/MAL/H DAWA SUPER MEDIC MICLOCIN MICONAZOLE 2%W/W+0. DAWA LTD -PLOT KENYA TOPICAL 1.0X15.0 7/1/2013
DP/4872 LIMITED LTD CREAM NITRATE + 5%W/W+0. NO.7879/8 BABA ROAD EXTERNAL G TUBE
CLOBETASOL 1W/W RUARAKA NAIROBI CREAMS
PROPRIONAT
E+
GENTAMICN
2402 NDA/MAL/H ASTRA LIFE ASTRA PHARMA FLUCAS FLUCONAZOL 200MG ASTRA LIFE CARE (INDIA) INDIA ORAL SOLID 1.0X4.0 7/1/2011
DP/4873 CARE (INDIA) (U) LIMITED E PVT.LTD-PLOT NO. 57/P, ORDINARY CAPSULE
PVT LTD SARKHEJ-BAVLA CAPSULES BLISTER
AHMEDABAD INDIA
2403 NDA/MAL/H SANOFI- SURGIPHARM CLEXANE ENOXAPARIN 100MG/ML SANOFI WINTHROP FRANCE PARENTERAL 1.0X2.0X0 7/1/2009
DP/4874 AVENTIS (U) LIMITED SODIUM INDUSTRIE-180 RUE JEAN ORDINARY .6 ML PRE-
JAURE'S BP 94702, PRE-FILLED FILLED
MAISONS-ALFORT CEDEX SYRINGES SYRINGE
2404 NDA/MAL/H PHARM MARIE STOPES MISOCLEAR MISOPROSTO 200MCG ACME FORMULATION PVT INDIA ORAL SOLID 1.0X10.0 7/1/2011
DP/4875 ACCESS UGANDA L LTD,-ACME FORMULATION ORDINARY TABLET
AFRICA LTD LIMITED PVT LTD ROPAR ROAD TABLETS BLISTER
NALAGARH DIST SOLAN
HIMACHAL PRADESH
2407 NDA/MAL/H EUROLIFE AIVEEN (U) FLUCOLIFE FLUCONAZOL 200MG/10 EUROLIFE HEALTHCARE INDIA PARENTERAL 1.0X100.0 7/1/2010
DP/4878 HEALTHCARE LIMITED E 0ML PVT LTD-BHAGWANPUR ORDINARY ML
VIALS/BOTTL
ES
DP/4879 AVENTIS (U) LIMITED SODIUM INDUSTRIE--180 RUE JEAN ORDINARY .2 ML PRE-
JUARES BP 4094702 PRE-FILLED FILLED
MAISON ALFORT CEDEX SYRINGES SYRINGE
2409 NDA/MAL/H CIPLA LTD QUALITY MISOPROST MISOPROSTO 200MCG CIPLA LTD .-CIPLA GOA INDIA ORAL SOLID 1.0X1.0X4 7/1/2014
DP/4880 CHEMICALS LTD - 200 L UNIT 8 L-147 TO L-147/1 L- ORDINARY .0 TABLET
HUMAN 147-3 TO L-138 VERNA TABLETS BLISTER,1.
INDUSTRIAL ESTATE 0X7.0X4.0
VERNA GOA TABLET
BLISTER,1.
0X15.0X4.
0 TABLET
BLISTER
2410 NDA/MAL/H ASTRA ASTRA PHARMA ASFULVIN- GRISEOFULVI 500MG ASTRA LIFE CARE (INDIA) INDIA ORAL SOLID 1.0X10.0X 7/1/2008
DP/4884 PHARMA (U) (U) LIMITED 500 N PVT.LTD-PLOT NO. 57/P, ORDINARY 10.0
LIMITED SARKHEJ-BAVLA TABLETS TABLET
AHMEDABAD INDIA
DP/4887 PHARMACEUT PHARMA E PHARMACEUTICALS LTD- ORDINARY CAPSULE
BOX 28629, 2081
LEFKOSIA
BOX 28629, 2081
LEFKOSIA
BOX 28629, 2081
LEFKOSIA
2414 NDA/MAL/H DAR AL DAWA GAMA CLOMIFERT CLOMIPHENE 50MG DAR AL DAWA-DAR AL JORDAN ORAL SOLID 1.0X1.0X1 7/1/2010
DP/4895 DEVELOPMEN PHARMACEUTIC DAWA DEVELOPMENT ORDINARY 0.0
T AND ALS (U) LIMITED AND INVESTMENT CO LTD. TABLETS TABLET
AMMAN, JORDAN
2415 NDA/MAL/H BAYER SURGIPHARM AVELOX IV MOXIFLOXACI 400MG/25 BAYER PHARMA AG - GERMANY PARENTERAL 1.0X250.0 7/1/2004
DP/4901 PHARMA AG (U) LIMITED N HCL 0ML 51368 LEVERKUSEN ORDINARY ML
GERMANY INFUSION BOTTLE
VIALS/BOTTL
ES
2416 NDA/MAL/H GITTOES GITTOES CMT- MAGNESIUM 250MG+12 AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1.0X100.0 7/1/2008
DP/4903 PHARMACEUT PHARMACEUTIC TABLETS TRISILICATE+ 0MG+0.00 NO.33,SECTOR ORDINARY X10.0
ICALS LIMITED ALS LIMITED DRIED 3ML II,VASAI,TALUKA INDL CO- CHEWABLE TABLET
ALUMINIUM OP ESTATE LTD,GAURAI TABLETS BLISTER,1.
HYDROXIDE+ PADA,VASAI(E)DIST.THAN 0X1000.0
PEPPERMINT E INDIA TABLET
OIL CONTAIN
ER,1.0X10
.0X10.0
TABLET
BLISTER
2417 NDA/MAL/H NOVO STAR MIXTARD INSULIN 100 I.U/ML NOVO NORDISK PHARMA- DENMARK PARENTERAL 1.0X10.0 7/1/1997
DP/4904 NORDISK PHARMACEUTIC 30 HUMAN NOVO ALLE ORDINARY S ML VIAL
ALS LTD C VIALS
2418 NDA/MAL/H XEPA-SOUL DELMAW AVORAX ACYCLOVIR 5%W/W XEPA-SOUL PATTINSON MALAYSIA TOPICAL 1.0X5.0 G 7/1/1997
DP/4905 PATTINSON ENTERPRISES CREAM (MALAYSIA) SDN BHD-1-5 EXTERNAL TUBE
LIMITED CHENG INDUSTRIAL CREAMS
ESTATE, 75250
MALEKA, MALAYSIA
2419 NDA/MAL/H XEPA SOUL DELMAW AVORAX ACYCLOVIR 200MG XEPA-SOUL PATTINSON MALAYSIA ORAL SOLID 1.0X5.0X5 7/1/1997
DP/4906 PATTISON (M) ENTERPRISES TABLETS (MALAYSIA) SDN BHD-1-5 ORDINARY .0 TABLET
SDN BHD LIMITED CHENG INDUSTRIAL TABLETS STRIP
ESTATE, 75250
MALEKA, MALAYSIA
2420 NDA/MAL/H NOVO STAR MIXTARD BIPHASIC 100 I.U/ML NOVO NORDISK A/S - DENMARK PARENTERAL 1.0X1.5 7/1/1997
DP/4908 NORDISK PHARMACEUTIC 30 PENFILL ISOPHANE NOVO ALLE DK-2880 ORDINARY ML
ALS LTD INSULIN BAGSVAERD CARTRIDGES CARTRIDG
(HUMAN) E,1.0X5.0X
3.0 ML
CARTRIDG
E
2421 NDA/MAL/H AXA VITACARE AXAGYL METRONIDAZ 0.5%W/V AXA PARENTERAL LIMITED- INDIA PARENTERAL 1.0X100.0 7/1/2015
DP/4909 PARENTERALS LIMITED OLE PLOT NO.936,937&939, ORDINARY ML
LTD VILL. KISHANPUR, INFUSION BOTTLE
JAMALPUR,ROORKEE VIALS/BOTTL
2422 NDA/MAL/H ABACUS ABACUS FLUZOL FLUCONAZOL 200MG ABACUS PARENTERAL UGANDA PARENTERAL 1.0X100.0 7/1/2011
DP/4910 PARENTERAL PARENTERAL E DRUGS LIMITED-BLOCK ORDINARY ML
DRUGS DRUGS LIMITED 191, PLOT NO. 114, INFUSION BOTTLE
LIMITED GWAWANYA KINGA AND VIALS/BOTTL
KAPEKA MUKONO ES
DISTRICT, UGANDA.
2423 NDA/MAL/H EMCURE HARLEYS MOFILET- MYCOPHENO 500MG EMCURE INDIA ORAL SOLID 1.0X10.0 7/1/2008
DP/4911 PHARMACEUT UGANDA 500 LATE PHARMACEUTICALS ORDINARY TABLET
ICALS LTD LIMITED MOFETIL LIMITED -LANE NO.3 TABLETS BLISTER
PHASE II SIDCO
INDUSTRIAL COMPLEX
BARI-BRAHMANA JAMMU
,181133
2424 NDA/MAL/H KOTRA ABACUS AXCEL MAGNESSIU 400MG/5 KOTRA PHARMA (M) SDN. MALAYSIA ORAL LIQUID 1.0X120.0 7/1/2010
DP/4917 PHARMA (M) PHARMA EVILINE M ML+400M BHD-1 JALAN TTC 12, ORDINARY ML
SDN BHD (AFRICA) FORTE HYDROXIDE G/5ML+40 CHENG INDUSTRIAL SUSPENSION BOTTLE
LIMITED SUSPENSIO +ALUMINIUM MG/5ML ESTATE, 75250 MELAKA S
N HYDROXIDE+S MALYSIA
IMETHICONE
2425 NDA/MAL/H KOTRA ABACUS AXCEL FUSIDIC 2%,W/W,+ KOTRA PHARMA (M) SDN. MALAYSIA TOPICAL 1.0X15.0 7/1/2008
DP/4919 PHARMA (M) PHARMA FUSIDIC ACID+BETAM 0.1% W/W BHD-1 JALAN TTC 12, EXTERNAL G TUBE
SDN BHD (AFRICA) ACID- B ETHASONE 17 CHENG INDUSTRIAL CREAMS
LIMITED CREAM VALERATE ESTATE, 75250 MELAKA
MALYSIA
2426 NDA/MAL/H LEBEN ANDYCO FOLIBEN FOLIC ACID 5MG LEBEN LAB PVT LTD-L4 INDIA ORAL SOLID 1.0X10.0X 7/1/2011
DP/4920 LABORATORIE PHARMACY PHASE 111 MIDCS AKOLA ORDINARY 20.0
S LTD (UGANDA) LTD 444104 MAHARASTRA TABLETS TABLET
INDIA BLISTER,1.
0X1000.0
TABLET
CONTAIN
ER
2427 NDA/MAL/H KOPRAN TATA UGANDA CIPROQUIN- CIPROFLOXAC 500MG KOPRAN LIMITED-VILLAGE- INDIA ORAL SOLID 10.0X10.0 7/1/1999
DP/4922 LIMITED LIMITED 500 IN SAVROLI (KHOPOLI), ORDINARY TABLET
TALUKA- KHALAPUR, DIST. FILM- BLISTER
RAIGAD, MAHARASHTRA, COATED
INDIA TABLETS
2428 NDA/MAL/H GITTOES GITTOES MULTIVIT MULTIVITAMI MULTI- AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1.0X1000. 7/1/2001
DP/4924 PHARMACEUT PHARMACEUTIC TABLET N INGREDIEN NO.33,SECTOR ORDINARY 0 TABLET
ICALS LIMITED ALS LIMITED T II,VASAI,TALUKA INDL CO- CHEWABLE CONTAIN
OP ESTATE LTD,GAURAI TABLETS ER
E INDIA
2429 NDA/MAL/H LABORATORY HARLEYS FOLIC ACID FOLIC ACID 5MG LABORATORY & ALLIED KENYA ORAL SOLID 1.0X1000. 7/1/1997
DP/4926 &ALLIED LTD UGANDA LTD-PLOT NO. 209/10349 ORDINARY 0 TABLET
LIMITED OFF MOMBASA ROAD, TABLETS CONTAIN
NAIROBI ER,1.0X10
KENYA. TABLET
BLISTER
2430 NDA/MAL/H NORVATIS LABOREX AZOPT BRINZOLAMI 10MG/ML ALCON COUVREUR NV- BELGIUM OPHTHALMI 1.0X5.0 7/1/2009
DP/4927 PHARMA AG- UGANDA DE RIJKSWEG 14, B-2870 C ML
SWITZERLAN LIMITED PUURS BELGIUM SUSPENSION BOTTLE
D S
2431 NDA/MAL/H AFRICURE ROYAL PHARMA FOLIC ACID FOLIC ACID 5MG AFRICURE INDIA ORAL SOLID 1.0X1000. 7/1/1997
DP/4928 PHARMACEUT 2011 LIMITED TABLETS PHARMACEUTICALS ORDINARY 0 TABLET
ICALS (INDIA) (INDIA) PRIVATE LIMITED- TABLETS CONTAIN
LTD PLOT 9-12,DEWAN & SONS ER,1.0X10
INDL. AREA, .0X10.0
INDIA. STRIP
2432 NDA/MAL/H MARTINDALE LABOREX MORPHINE MORPHINE 15MG/ML MARTINDALE UNITED PARENTERAL 1.0X1.0 7/1/1997
DP/4929 AND AURUM UGANDA INJECTION PHARMACEUTICAL KINGDOM ORDINARY ML
PHARMACEUT LIMITED LIMITED -BAMPTON ROAD AMPOULES AMPOULE
ICAL RMM38UG ENGLAND
2433 NDA/MAL/H MARTINDALE LABOREX MORPHINE MORPHINE 10MG/ML MARTINDALE UNITED PARENTERAL 1.0X1.0 7/1/1997
DP/4932 AND AURUM UGANDA INJECTION PHARMACEUTICAL KINGDOM ORDINARY ML
PHARMACEUT LIMITED LIMITED -BAMPTON ROAD AMPOULES AMPOULE
ICAL RMM38UG ENGLAND
2434 NDA/MAL/H KAMPALA KAMPALA AZUDOX DOXYCYCLINE 100MG KAMPALA UGANDA ORAL SOLID 1.0X100.0 7/1/1997
DP/4933 PHARMACEUT PHARMACEUTIC HYDROCHLOR PHARMACEUTICAL ORDINARY CAPSULE
ICAL AL INDUSTRIES IDE INDUSTRIES (1996) LTD - CAPSULES CONTAIN
INDUSTRIES 1996 LIMITED PLOT NO. M444B, ER,1.0X10
LTD STRETCHER ROAD, .0
NTINDA, KAMPALA CAPSULE
BLISTER,1.
0X500.0
CAPSULE
CONTAIN
ER,1.0X25
0.0
2435 NDA/MAL/H GLAXOSMITH UNITED BACTROBA MUPIROCIN 2%W/W GLAXO OPERATIONS UK UNITED TOPICAL 1.0X3.0 G 7/1/1997
DP/4935 KLINE HEALTHCARE N LTD -PRIORY STREET, KINGDOM EXTERNAL TUBE,1.0X
PHARMACEUT DISTRIBUTORS OINTMENT WARE OINTMENTS 15.0 G
ICAL KENYA LTD HERTFORDSHIRE SG12 TUBE
LTD 0DJ, UK
2436 NDA/MAL/H RENE RENE COMBIFEN IBUPROFEN + 400MG + RENE INDUSTRIES LTD- UGANDA ORAL SOLID 1.0X10.0 7/1/2011
DP/4936 INDUSTRIES INDUSTRIES PARACETAM 500MG PLOT 680, KAMULI ROAD, ORDINARY TABLET
LTD LIMITED OL KIREKA, P.O BOX 6034, FILM- BLISTER
KAMPALA COATED
TABLETS
2437 NDA/MAL/H JASSEN-CILAG LABOREX MOTILIUM DOMPERIDO 10MG SPECPHARM HOLDINGS FRANCE ORAL SOLID 1.0X20.0 7/1/1997
DP/4937 (PTY) LTD UGANDA NE (PTY) LTD. -15TH ROAD, ORDINARY TABLET
LIMITED HALFWAY HOUSE, 1685 FILM- CARTON,1
COATED .0X30.0
TABLETS TABLET
CARTON
2438 NDA/MAL/H GLAXOSMITH UNITED BACTROBA MUPIROCIN 2%W/W GLAXO OPERATIONS UK UNITED TOPICAL 1.0X1.0X1 7/1/2012
DP/4938 KLINE HEALTHCARE N CREAM LTD -PRIORY STREET, KINGDOM EXTERNAL 5.0 G
PHARMACEUT DISTRIBUTORS WARE CREAMS TUBE
ICAL KENYA LTD HERTFORDSHIRE SG12
LTD 0DJ, UK
2439 NDA/MAL/H RENE RENE FOLIREN FOLIC ACID 5MG RENE INDUSTRIES LTD- UGANDA ORAL SOLID 1.0X1000. 7/1/2005
DP/4939 INDUSTRIES INDUSTRIES PLOT 680, KAMULI ROAD, ORDINARY 0 TABLET
KAMPALA ER
2440 NDA/MAL/H GITTOES GITTOES FOLON FOLIC ACID 5MG AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1.0X1000. 7/1/2006
E INDIA TABLET
BLISTER
2441 NDA/MAL/H ASTRAZENEC MACNAUGHTON NOLVADEX TAMOXIFEN 20MG ASTRAZENECA UK LIMITED UNITED ORAL SOLID 1.0X3.0X1 7/1/1997
DP/4943 A LIMITED -ASTRAZENECA UK KINGDOM ORDINARY 0.0
LIMITED SILK ROAD FILM- TABLET
BUSINESS PARK, MACCLES COATED BLISTER
FIELD,CHESHIRE SK 10 TABLETS
2NA,
2442 NDA/MAL/H XEPA SOUL DELMAW BENA DIPHENHYDR 14MG + XEPA-SOUL PATTINSON MALAYSIA ORAL LIQUID 1.0X120.0 7/1/1997
DP/4944 PATTISON (M) ENTERPRISES EXPECTORA AMINE HCL + 135MG + (MALAYSIA) SDN BHD-1-5 ORDINARY ML
SDN BHD LIMITED NT AMMONIUM 57.5MG CHENG INDUSTRIAL LIQUIDS BOTTLE
CHLORIDE + ESTATE, 75250
SODIUM MALEKA, MALAYSIA
CITRATE
2443 NDA/MAL/H DAR AL DAWA GAMA FORMIT METFORMIN 850MG DAR AI DAWA-NA UR JORDAN ORAL SOLID 1.0X3.0X1 7/1/2011
INVESTMENT BLISTER
CO LTD
2444 NDA/MAL/H ESAPHARM BYAMAKA MOVATE CLOBETASOL 0.05%W/W ESAPHARMA SRL-VIA DE ITALY TOPICAL 1.0X30.0 7/1/1999
DP/4946 SRL PHARMACEUTIC GASPERI, 13-20066 MELZO EXTERNAL G TUBE
AL COMPANY (MILAN) ITALY CREAMS
LTD
2445 NDA/MAL/H DAR AL DAWA GAMA FORMIT METFORMIN 1000MG DAR AL DAWA-DAR AL JORDAN ORAL SOLID 1.0X3.0X1 7/1/2010
DP/4948 DEVELOPMEN PHARMACEUTIC 1000 HYDROCHLOR DAWA DEVELOPMENT ORDINARY 0.0
T AND ALS (U) LIMITED IDE AND INVESTMENT CO LTD. TABLETS TABLET
AMMAN, JORDAN
2446 NDA/MAL/H JOHNSON&JO PHILLIPS BENYLIN DEXTROMET 15MG/ML JOHNSON&JOHNSON PTY SOUTH ORAL LIQUID 1.0X100.0 7/1/1997
DP/4949 HNSON PTY PHARMACEUTIC DRY HORPHAN LTD.-EDMS BPK241 MAIN AFRICA ORDINARY ML
LTD ALS (UGANDA) COUGH DM HYDROBROM ROAD /HOOFWEG SYRUPS BOTTLE
LIMITED IDE 241,RETREAT 7945,SOUTH
AFRICA
2447 NDA/MAL/H DAR AL DAWA GAMA FORMIT METFORMIN 500MG DAR AL DAWA-DAR AL JORDAN ORAL SOLID 1.0X5.0X1 7/1/2009
DP/4950 DEVELOPMEN PHARMACEUTIC 500 DAWA DEVELOPMENT ORDINARY 0.0
T AND ALS (U) LIMITED AND INVESTMENT CO LTD. FILM- TABLET
INVESTMENT NA’UR PRINCE HASHEM COATED BLISTER
CO LTD BIN AL-HUSSEIN STREET. TABLETS
AMMAN, JORDAN
2448 NDA/MAL/H JOHNSON&JO PHILLIPS BENYLIN DIPHENHYDR 12.5 JOHNSON&JOHNSON PTY SOUTH ORAL LIQUID 1.0X100.0 7/1/1997
DP/4951 HNSON PTY PHARMACEUTIC ORIGINAL AMINE MG/5ML + LTD.-EDMS BPK241 MAIN AFRICA ORDINARY ML
LTD ALS (UGANDA) HYDROCHLOR 125 ROAD /HOOFWEG SYRUPS BOTTLE,1.
LIMITED IDE + MG/5ML 241,RETREAT 7945,SOUTH 0X200.0
AMMONIUM AFRICA ML
CHLORIDE BOTTLE,1.
0X2.5 L
BOTTLE
2449 NDA/MAL/H JOHNSON&JO PHILLIPS BENYLIN DIPHENHYDR 12.5MG/5 JOHNSON&JOHNSON PTY SOUTH ORAL LIQUID 1.0X100.0 7/1/1997
DP/4952 HNSON PTY PHARMACEUTIC WITH AMINE HCL + ML LTD.-EDMS BPK241 MAIN AFRICA ORDINARY ML
LTD ALS (UGANDA) CODEINE AMMONIUM +125MG/5 ROAD /HOOFWEG SYRUPS BOTTLE,1.
LIMITED CHLORIDE + ML 241,RETREAT 7945,SOUTH 0X200.0
CODEINE +10MG/5 AFRICA ML
PHOSPHATE ML BOTTLE
2450 NDA/MAL/H MEGA ABACUS NAT-B MULTI- MULTI- MEGA LIFE SCIENCES THAILAND ORAL SOLID 1.0X3.0X1 7/1/2009
DP/4953 LIFESCIENCES PHARMA INGREDIENT INGREDIEN PUBLIC COMPANY ORDINARY 0.0
(AUSTRALIA) (AFRICA) T LIMITED-384 SOIB OTHER CAPSULE
INDUSTRIAL ESTATE
SAMUTPRAKARN 10280
2451 NDA/MAL/H NIRMA LIFE PHARMA COMPOUN COMPOUND MULTI ACULIFE HEALTHCARE INDIA PARENTERAL 1.0X500.0 7/1/1997
DP/4955 LIMITED. AFRICA LIMITED D SODIUM SODIUM INGREDIEN PVT. LTD-VILLAGE ORDINARY ML
LACTATE LACTATE T SACHANA ,TALUKA - INFUSION BOTTLE
INFU. VIRAMGAM , VIALS/BOTTL
AHMEDABAD 382150 ES
GUJARAT
2452 NDA/MAL/H UNIQUE PLANET CONTRAPA IOHEXOL 350MG UNIQUE INDIA PARENTERAL 1.0X50.0 7/1/2010
DP/4956 PHARMACEUT PHARMACEUTIC QUE 350 PHARMACEUTICAL ORDINARY ML VIAL
ICALS ALS UGANDA LABORATORIES, (A VIALS
LABORATORIE LTD DIVISION OF J.B
S CHEMICALS &
PANOLI 394 116
2453 NDA/MAL/H GLENMARK STAR MUMFER IRON (111) 100MG + GLENMARK INDIA ORAL SOLID 1.0X3.0X1 7/1/2004
DP/4957 PHARMACUTI PHARMACEUTIC POLYMALTOS 500MCG PHARMACEUTICALS LTD ORDINARY 0.0
CALS LTD ALS LTD E COMPLEX + PLOT E-PLOT NO. E-37, 39, CHEWABLE TABLET
FOLIC ACID MIDC AREA, SATPUR, COATED BLISTER
NASIK - 422 007, TABLETS
MAHARASHTRA
2454 NDA/MAL/H TROIKAA ABACUS BENZOSED MIDAZOLAM 1MG/ML TROIKAA INDIA PARENTERAL 1.0X1.0X5 7/1/2011
DP/4958 PHARMACEUT PHARMA PHARMACEUTICALS LTD .- ORDINARY .0 ML
ICALS LIMITED (AFRICA) SARA INDUSTRIAL ESTATE VIALS VIAL
248197 UTTARAKHAND,
INDIA
2455 NDA/MAL/H STEDMAN VEERAM CONTUS CHLORPHENI 1MG/ STEDMAN INDIA ORAL LIQUID 1.0X50.0 7/1/2011
DP/4959 PHARMACEUT HEALTHCARE PAEDIATRIC RAMINE / 5MG/ PHARMACEUTICALS PVT ORDINARY ML
ICALS PVT. (U) LIMITED LINCTUS PHENYLEPHRI 10MG LIMITED-NO. C-4, SIDCO LIQUIDS BOTTLE
LTD NE / PHARMACEUTICAL
DEXTROMET COMPLEX, ALATHUR,
HORPHAN THIRUPORUR,
2456 NDA/MAL/H SK AGE ABACUS BETAD BETAMETHAS 0.05%W/W S.KANT HEALTHCARE LTD- INDIA TOPICAL 1.0X1.0X3 7/1/2010
DP/4962 EXPORTS PHARMA ONE PLOT 1802, 1805, GIDC EXTERNAL 0.0 G
(AFRICA) DIPROPRION PHASE III VAPI 39179, CREAMS TUBE,1.0X
LIMITED ATE GUJARAT 1.0X15.0
G TUBE
2457 NDA/MAL/H STEDMAN VEERAM CONTUS CHLORPHENA IMG+5MG STEDMAN INDIA ORAL LIQUID 1.0X50.0 7/1/2011
DP/4964 PHARMACEUT HEALTHCARE PLUS MINE+PHENY +160MG PHARMACEUTICALS PVT ORDINARY ML
ICALS PVT. (U) LIMITED PAEDIATRIC LEPHRINE+PA LIMITED-NO. C-4, SIDCO SUSPENSION BOTTLE
LTD SUSPENSIO RACETAMOL PHARMACEUTICAL S
N COMPLEX, ALATHUR,
THIRUPORUR,
2458 NDA/MAL/H BETA BETA BETAFEN IBUPROFEN 100MG/5 BETA HEALTHCARE KENYA ORAL LIQUID 1.0X60.0 7/1/2001
DP/4965 HEALTHCARE HEALTHCARE SYRUP ML INTERNATIONAL LTD - - ORDINARY ML
INTERNATION UGANDA PLOT SYRUPS BOTTLE,1.
AL LTD LIMITED NO.209/6554,MOGADISHU 0X100.0
ROAD,OFF LUNGA LUNGA ML
INDUSTRIAL AREA, BOTTLE
P.O.BOX 42569-001000
NAIROBI,KENYA
2459 NDA/MAL/H STEDMAN VEERAM CONTUS- CHLORPHENI 2MG + STEDMAN INDIA ORAL SOLID 1.0X10.0X 7/1/2010
DP/4966 PHARMACEUT HEALTHCARE 650 RAMINE + 5MG + PHARMACEUTICALS PVT ORDINARY 10.0
ICALS PVT. (U) LIMITED PHENYLEPHRI 650MG LIMITED-NO. C-4, SIDCO TABLETS TABLET
LTD NE + PHARMACEUTICAL BLISTER,1.
PARACETAM COMPLEX, ALATHUR, 0X50.0X1.
OL THIRUPORUR, 0X6.0
KANCHEEPURAM DIST 603 TABLET
110, TAMILNADU, INDIA BLISTER
2460 NDA/MAL/H MEDIPHARM MEDIPHARM PIRITEX MULTI- MULTI- MEDIPHARM INDUSTRIES UGANDA ORAL LIQUID 1.0X60.0 7/1/1998
DP/4967 SALES INDUSTRIES JUNIOR INGREDIENT INGREDIEN (E.A) LTD-PLOT 65, ORDINARY ML
LIMITED (E.A) LTD T KAKAJJO ROAD, SYRUPS BOTTLE,1.
BWEYOGERERE 0X100.0
ML
BOTTLE
2461 NDA/MAL/H GITTOES GITTOES FRUSEMIDE FUROSEMIDE 10MG/ML NINGBO DAHONGYING CHINA PARENTERAL 1.0X10.0X 7/1/2008
DP/4968 PHARMACEUT PHARMACEUTIC INJECTION PHARMACEUTICAL CO.LTD- ORDINARY 2.0 ML
ICALS LIMITED ALS LIMITED NO. 396 MINGZHU ROAD, AMPOULES AMPOULE
CHINA
2462 NDA/MAL/H GITTOES GITTOES BENZATHIN BENZATHINE 2.4 M.U CSPC ZHONGNUO CHINA PARENTERAL 1.0X2.4 7/1/2001
DP/4969 PHARMACEUT PHARMACEUTIC E PENICILLIN PHARMACEUTICAL ORDINARY MU VIAL
ICALS LIMITED ALS LIMITED PENICILLIN (SCIJIAZHUANG) CO. LTD DRY VIALS
WORKSHOP -NO. 88
YANGZI ROAD,
SHIJIAZHUANG CITY,
2463 NDA/MAL/H MEDIPHARM MEDIPHARM PIRITEX DIPHENHYDR 14MG+15 MEDIPHARM INDUSTRIES UGANDA ORAL LIQUID 1.0X100.0 7/1/2006
DP/4970 SALES INDUSTRIES DRY AMINE HCL/ MG+30MG (E.A) LTD-PLOT 65, ORDINARY ML
LIMITED (E.A) LTD COUGH DEXTROMET /5ML KAKAJJO ROAD, SYRUPS BOTTLE
SYRUP HORPHAN BWEYOGERERE
HBR/
PSEUDOEPHE
DRINE HCL
2464 NDA/MAL/H AFRICURE ROYAL PHARMA FRUSEMIDE FUROSEMIDE 40MG AFRICURE INDIA ORAL SOLID 1.0X10.0X 7/1/1997
DP/4971 PHARMACEUT 2011 LIMITED TABLETS PHARMACEUTICALS ORDINARY 10.0
ICALS (INDIA) (INDIA) PRIVATE LIMITED- TABLETS TABLET
PRIVATE PLOT 9-12,DEWAN & SONS STRIP,1.0X
LIMITED INDL. AREA, 1000.0
INDIA. CONTAIN
ER
2465 NDA/MAL/H JOHNSON PHILLIPS COOLMINT MENTHOL + 0.02% + JOHNSON&JOHNSON PTY SOUTH ORAL LIQUID 1.0X250.0 7/1/2001
DP/4972 &JOHNSON PHARMACEUTIC LISTERINE ALCOHOL 4.58ML LTD.-EDMS BPK241 MAIN AFRICA ORDINARY ML
(PTY) LTD ALS (UGANDA) 95% ROAD /HOOFWEG LIQUIDS CONTAIN
LIMITED 241,RETREAT 7945,SOUTH ER,1.0X50
AFRICA 0.0 ML
CONTAIN
ER
2466 NDA/MAL/H MERCK UNITED PERGOVERI FOLLITROPIN 150 I.U/75 MERCK SERONO S.A. SWITZERLAN PARENTERAL 1.0X1.0 7/1/2014
DP/4973 HEALTHCARE S ALFA/LUTROP I.U (MSA) -1170 SUCCURSALE D ORDINARY ML VIAL +
DISTRIBUTORS IN ALFA D’AUBONNE ZONE DRY VIALS 1*1ML
LTD INDUSTRIELLE DE VIAL OF
L’OURIETTAZ, WFI
SWITZERLAND
2467 NDA/MAL/H COSMOS LTD ASTRA PHARMA FRUSEMIDE FUROSEMIDE 40MG COSMOS LIMITED-- KENYA ORAL SOLID 1.0X100.0 7/1/1998
DP/4974 (U) LIMITED TABLETS BP RANGWA ROAD, OFF ORDINARY TABLET
40MG LUNGA LUNGA ROAD,P.O TABLETS CONTAIN
INDUSTRIAL AREA 00.0
TABLET
CONTAIN
ER
2468 NDA/MAL/H MEGA ABACUS PERGLIM 2 GLIMEPIRIDE 2MG INVENTIA HEALTHCARE INDIA ORAL SOLID 1.0X3.0X1 7/1/2015
DP/4976 LIFESCIENCES PHARMA PVT. LTD .-FI – FI /1 ORDINARY 0.0
(AUSTRALIA) (AFRICA) ADDITIONAL TABLETS TABLET
PTY LTD LIMITED AMBERNATH(EAST) – 421 BLISTER
506,MAHARASHTRA DIST.
THANE, INDIA
2469 NDA/MAL/H CIRON DRUGS RENE FUROSEMI FUROSEMIDE 10MG/ML CIRON DRUGS AND INDIA PARENTERAL 1.0X10.0X 7/1/2010
DP/4979 & PHARMACY LTD DE PHARMACEUTICALS PVT ORDINARY 10.0X2.0
PHARMACEUT LTD-N-118 M.I.D.C, AMPOULES ML
ICALS PVT LTD TAAPUR,BOISAR,DIST.THA AMPOULE
2470 NDA/MAL/H COSMOS LTD ASTRA PHARMA COSMAG MAGNESIUM 370MG COSMOS LTD.-RANGWE KENYA ORAL SOLID 1.0X100.0 7/1/1998
DP/4982 (U) LIMITED TABLETS TRISILICATE ROAD; OFF LUNGA LUNGA ORDINARY TABLET
ROAD. P.O BOX 414 33, CHEWABLE CONTAIN
NAIROBI TABLETS ER,1.0X10
00.0
TABLET
CONTAIN
ER
2471 NDA/MAL/H PT SAMBE MEDVIN PELASTIN IMIPENEM + 500MG + PT SANBE FARMA-JI INDONESIA PARENTERAL 1.0X1.0 G 7/1/2011
DP/4983 FARMA PHARMA CILASTATIN 500MG LEUWIGAJAH I62 CIMINDI ORDINARY VIAL
INDONESIA
2472 NDA/MAL/H CADILA KARURI PYRAZINA PYRAZINAMI 400 MG CADILA INDIA ORAL SOLID 1.0X24.0X 7/1/2009
DP/4987 PHARMACEUT PHARMACEUTIC MIDE DE PHARMACEUTICALS ORDINARY 28.0
STATE, INDIA
2473 NDA/MAL/H MYLAN KIMSY MEDS HYAN LEVONORGES 0.03MG MYLAN LABORATORIES INDIA ORAL SOLID 1.0X28.0 7/1/2006
PLOT NO.20 & 21,
PHARMEZ, SARKHEJ-
BAVLA NATIONAL
2474 NDA/MAL/H UNIQUE PLANET PAMIDOL*3 IOPAMIDOL 755.3MG/ UNIQUE INDIA PARENTERAL 1.0X50.0 7/1/2010
DP/4999 PHARMACEUT PHARMACEUTIC 70 ML PHARMACEUTICAL ORDINARY ML
ICAL ALS UGANDA LABORATORIES, (A VIALS VIAL,1.0X
LABORATORIE LTD DIVISION OF J.B 1.0X100.0
S CHEMICALS & ML VIAL
PANOLI 394 116
2475 NDA/MAL/H ELI-LILLY LABOREX HUMALOG INSULIN 25I.U+75I. LILLY FRANCE SA-FRANCE FRANCE PARENTERAL 1.0X10.0 7/1/2000
DP/5002 EXPORT SA UGANDA MIX 25 LISPRO + U ORDINARY S ML
LIMITED INSULIN C VIALS VIAL,1.0X
LISPRO 5.0X3.0
PROTAMINE ML
CARTRIDG
E
2476 NDA/MAL/H GLAXOSMITH BETA COFTA MULTI- N/A GLAXOSMITHKLINE KENYA ORAL SOLID 1.0X100.0 7/1/1997
DP/5004 KLINE HEALTHCARE TABLETS INGREDIENT LIMITED - -78392-00507, ORDINARY TABLET
LIMITED UGANDA VIWANDANI LIKONI ROAD LOZENGES CARTON,1
LIKONI LIMITED NAIROBI KENYA BETA .0X50.0
HEALTHCARE TABLET
INTERNATIONAL LTD - - CARTON,1
PLOT .0X150.0
NO.209/6554,MOGADISHU TABLET
ROAD,OFF LUNGA LUNGA CARTON
INDUSTRIAL AREA,
P.O.BOX 42569-001000
NAIROBI,KENYA
2477 NDA/MAL/H MACK SHURIK LTD COLD GO PARACETAM 325MG+10 TORQUE INDIA ORAL SOLID 1.0X50.0X 7/1/2010
DP/5005 BROWN OL+PHENYLE MG+2MG+ PHARMACEUTICALS LTD - ORDINARY 1.0X4.0
PHARMECEUT PHRINE 30MG ISSAPUR P.O DAPPAR TABLETS TABLET
ICALS PVT LTD HYDROCHLOR 140506 BLISTER
IDE+CHLORP
HENIRAMINE
MALEATE+CA
FFEINE
2478 NDA/MAL/H DELOBORIS ABACUS VIRUCID ACYCLOVIR 200MG DELORBIS CYPRUS ORAL SOLID 1.0X3.0X1 7/1/1997
LIMITED ERGATES INDUSTRIAL BLISTER,1.
AREA, 2643 ERGATES P.O. 0X25.0
BOX 28629, 2081 TABLET
LEFKOSIA CONTAIN
ER
2479 NDA/MAL/H XEPA SOUL DELMAW ZARIN CLOTRIMAZO 2%W/W XEPA-SOUL PATTINSON MALAYSIA TOPICAL 1.0X15.0 7/1/1997
DP/5010 PATTISON (M) ENTERPRISES CREAM LE (MALAYSIA) SDA BHD-1-5, EXTERNAL G TUBE
ESTATE, 75250, MELAKA,
MALAYSIA
2480 NDA/MAL/H UNIMED METAPLUS (U) COLDAFEX MULTI- MULTI- UNIMED INDIA-86,MAROL INDIA ORAL SOLID 1.0X50.0X 7/1/1997
DP/5011 LIMITED TABLETS INGREDIENT INGREDIEN COOPORATIVE ESTATE, ORDINARY 4.0
T M.V ROAD TABLETS TABLET
ANDHERE(E)MUMBAI STRIP,1.0X
400059 10.0X10.0
TABLET
BLISTER
2481 NDA/MAL/H CIRON DRUGS RENE GENTAMYC GENTAMYCIN 0.3%W/V CIRON DRUGS AND INDIA OPHTHALMI 1.0X10.0 7/1/2009
DP/5013 & PHARMACY LTD IN EYE/EAR PHARMACEUTICALS PVT C DROPS ML VIAL
PHARMACEUT DROPS LTD-N-118 M.I.D.C,
2482 NDA/MAL/H REGAL REGAL PHARMA COLDCAP PHENYLEPHRI 5MG+4MG REGAL KENYA ORAL SOLID 1.0X500.0 7/1/1997
DP/5015 PHARMACEUI (U) LTD CAPSULES NE PHARMACEUTICALS LTD- ORDINARY CAPSULE
CALS LTD HYDROCHLOR BABA DOGO ROAD, CAPSULES CONTAIN
IDE+CHLORP RAURAKA,NAIROBI,KENYA ER,1.0X10
HENIRAMINE 00.0
CAPSULE
CONTAIN
ER,1.0X8.
0X12.0
CAPSULE
BLISTER,1.
0X10.0X10
2483 NDA/MAL/H DISEASE KIMSY MEDS GENTAMYC GENTAMYCIN 40MG/ML GLAND PHARMA LTD -D.P INDIA PARENTERAL 1.0X10.0X 7/1/2000
DP/5016 CONTROL LTD IN SULPHATE PALLY DUNDIGAL POST ORDINARY 2.0 ML
TECHNOLOGI INJECTION QUTBULLAPUR MANDAL AMPOULES AMPOULE
ES LLC 419 RANGA REDDY DISTRICT
THE HYDERABAB 500043
PARKWAY
#120 GREER,
SC 29650
U.S.A.
2484 NDA/MAL/H REGAL REGAL PHARMA COLDCAP PARACETAM 120MG+6. REGAL KENYA ORAL LIQUID 1.0X100.0 7/1/1997
DP/5017 PHARMACEUI (U) LTD SYRUP OL+PROMETH 5MG+5MG PHARMACEUTICALS LTD- ORDINARY ML
CALS LTD AZINE +25MG BABA DOGO ROAD, SYRUPS BOTTLE
HYDROCHLOR RAURAKA,NAIROBI,KENYA
IDE+CODEINE
PHOSPATE+P
SEUDOEPHED
RINE
HYDROCHLOR
IDE
2485 NDA/MAL/H GLAXO UNITED VENTOLIN SALBUTAMOL 100MCG GLAXO WELLCOME FRANCE LUNG 1.0X200.0 7/1/1997
DP/5018 WELLCOME HEALTHCARE PRODUCTION.-ZONE ADMINISTRA METERED
(KENYA) LTD DISTRIBUTORS INDUSTRIELLE NO.2 23, TION DOSE
LTD RUE LAVOISIER 27000 METERED- CANNISTE
EVREUX,FRANCE. DOSE R
INHALER
2486 NDA/MAL/H EGYPTIAN WIDE COLOSPAS MEBEVERINE 135MG EGYPTIAN EGYPT ORAL SOLID 1.0X20.0 7/1/2011
DP/5019 INTERNATION SPECTRUM MIN FORTE INT.PHARMACEUTICAL ORDINARY TABLET
AL ENTERPRISES INDUSTRIES CO (E.I.P.C.O)- TABLETS BLISTER
PHARMACEUT (U) LIMITED EGYPTIAN
ICAL INT.PHARMACEUTICAL
INDUSTRIES INDUSTRIES CO (E.I.P.C.O)
COMPANY
2487 NDA/MAL/H GLAXO UNITED VENTOLIN SALBUTAMOL 2MG/ML GLAXO WELLCOME EGYPT KENYA ORAL LIQUID 1.0X150.0 7/1/1997
DP/5020 WELLCOME HEALTHCARE SAE.-EL SALAM CITY ORDINARY ML
(KENYA) LTD DISTRIBUTORS 11491, CAIRO SYRUPS BOTTLE,1.
LTD 0X100.0
ML
BOTTLE
2488 NDA/MAL/H PFIZER LABS LABOREX TERRA- MULTI- MULTI- FARMASIERRA SPAIN OPHTHALMI 1.0X10.0 7/1/1997
DP/5027 LTD UGANDA CORTRIL INGREDIENT INGREDIEN MANUFACTURING SL- C LIQUIDS ML
LIMITED T CARRATERA DE IRUN, KM BOTTLE,1.
26, 200, 28700 SAN 0X5.0 ML
SEBASTIAN DE LOS REYES BOTTLE,1.
0X4.0 ML
BOTTLE
2489 NDA/MAL/H THE HARLEYS DEEP HEAT MULTI- MULTI- COLEP LAUPHEIM GMBH UNITED TOPICAL 1.0X150.0 7/1/1997
DP/5028 MENTHOLAT UGANDA SPRAY INGREDIENT INGREDIEN & CO KG-FOCKESTRASSE KINGDOM EXTERNAL ML
UM LIMITED T 12, 88471, LAUPHEIM THE PRESSURISED CANNISTE
COMPANY MENTHOLATUM AEROSOLS R
LTD TWY COMPANY LTD, TWYFORD,-
1 REDWOOD AVENUE,
PEEL PARK CAMPUS EAST
KILBRIDE, G74 SCOTLAND
2490 NDA/MAL/H PFIZER LAB LABOREX SOLU- METHYLPRED 125MG/2 PFIZER GLOBAL BELGIUM PARENTERAL 1.0X2.0 7/1/1997
DP/5030 LTD UGANDA MEDROL NISOLONE ML MANUFACTURING ORDINARY ML
LIMITED HEMISUCCIN BELGIUM NV-RIJKSWEG DRY VIALS VIAL,1.0X
ATE 12, 2870 PUURS - 8.0 ML
BELGIUM VIAL
2491 NDA/MAL/H THE HARLEYS DEEP HEAT MULTI- MULTI- THE MENTHOLATUM UNITED TOPICAL 1.0X15.0 7/1/1997
DP/5031 MENTHOLAT UGANDA RUB INGREDIENT INGREDIEN COMPANY LTD, TWYFORD,- KINGDOM EXTERNAL G
UM LIMITED T 1 REDWOOD AVENUE, CREAMS TUBE,1.0X
COMPANY PEEL PARK CAMPUS EAST 35.0 G
LTD KILBRIDE, G74 SCOTLAND TUBE,1.0X
67.0 G
TUBE,1.0X
100.0 G
TUBE
2492 NDA/MAL/H REGAL REGAL PHARMA DELASED DEXTROMET 7.5MG/5M REGAL KENYA ORAL LIQUID 1.0X100.0 7/1/2004
DP/5032 PHARMACEUI (U) LTD DRY HORPHAN L PHARMACEUTICALS LTD- ORDINARY ML
CALS LTD COUGH BABA DOGO ROAD, SYRUPS BOTTLE
SYRUP RAURAKA,NAIROBI,KENYA
(NON
DROWSY)
2493 NDA/MAL/H ABACUS ABACUS MEBENDAZ MEBENDAZOL 100MG/5 MEDICAMEN BIOTECH LTD INDIA ORAL LIQUID 1.0X30.0 7/1/2014
DP/5035 PHARMA LTD PHARMA OLE E ML - -SP-1192 A&B PHASE IV ORDINARY ML
(AFRICA) INDUSTRIAL AREA SUSPENSION BOTTLE
LIMITED BHIWADI 301019 DIST. S
ALWAR (RAJASTHAN) -
INDIA
2494 NDA/MAL/H MYLAN NORVIK DEPO MEDROXYPR 150MG PT HARSEN INDONESIA PARENTERAL 1.0X20.0 7/1/2010
DP/5036 LABORATORIE ENTERPRISES PROGESTIN OGESTERONE LABORATORIES, JL RAYA - ORDINARY VIAL
S LIMITED LIMITED ACETATE JL RAYA BOGOR, KM 24.6, VIALS CARTON,1
JAKARTA TIMUR 13750 .0X25.0X1
.0 ML
VIAL
2495 NDA/MAL/H UNICHEM PHILLIPS M-CAM MELOXICAM 15MG UNICHEM LABORATORIES INDIA ORAL SOLID 1.0X4.0X5 7/1/2002
DP/5038 LABORATORIE PHARMACEUTIC TABLETS LIMITED-UNICHEM ORDINARY .0X10.0
S LTD ALS (UGANDA) LABORATORIES LIMITED. TABLETS TABLET
LIMITED UNIT II, VILLAGE BLISTER
173 205, HIMACHAL
PRADESH, INDIA
2496 NDA/MAL/H MEGA ABACUS GILOBA GINKO 40MG MEGA LIFE SCIENCES THAILAND ORAL SOLID 1.0X3.0X1 7/1/2010
DP/5039 LIFESCIENCES PHARMA BILOBA LIMITED-: PLANT I : 384 ORDINARY 0.0
(AUSTRALIA) (AFRICA) EXTRACT SOI 6, PATTANA 3 ROAD, CAPSULES CAPSULE
PTY LTD LIMITED BANGPOO INDUSTRIAL BLISTER
ESTATE, SAMUTPRAKAN
10280, THAILAND
2497 NDA/MAL/H PFIZER LABOREX DEPO- METHYLPRED 40MG/ML PFIZER GLOBAL BELGIUM PARENTERAL 1.0X1.0 7/1/1997
DP/5040 LABORATORIE UGANDA MEDROL NISOLONE MANUFACTURING ORDINARY ML
S (PTY) LTD LIMITED ACETATE BELGIUM NV-RIJKSWEG VIALS VIAL,1.0X
BELGIUM 12, 2870 PUURS - 2.0 ML
BELGIUM VIAL,1.0X
5.0 ML
VIAL
2498 NDA/MAL/H NORVATIS LABOREX MAXITROL DEXAMETHAS 0.1%W/W ALCON COUVREUR NV- BELGIUM OPHTHALMI 1.0X3.5 G 7/1/1997
DP/5041 PHARMA AG- UGANDA ONE/NEOMY +0.1%W/W RIJKSWEG 14, B-2870 C TUBE
SWITZERLAN LIMITED CIN/POLYMY +6000 I.U PUURS BELGIUM OINTMENTS
D XIN B
2499 NDA/MAL/H COSMOS LTD ASTRA PHARMA COSATRIM CO- 960MG COSMOS LIMITED-- KENYA ORAL SOLID 1.0X1000. 7/1/1998
DP/5042 (U) LIMITED DS TABLETS TRIMOXAZOL RANGWA ROAD, OFF ORDINARY 0 TABLET
E LUNGA LUNGA ROAD,P.O TABLETS CONTAIN
INDUSTRIAL AREA 0.0
TABLET
CONTAIN
ER,1.0X10
0.0
TABLET
CONTAIN
ER
2500 NDA/MAL/H NORVATIS LABOREX MAXITROL DEXAMETHAS 0.1%W/W+ ALCON COUVREUR NV- BELGIUM OPHTHALMI 1.0X5.0 7/1/1997
DP/5043 PHARMA AG- UGANDA ONE/NEOMY 3500I.U/M RIJKSWEG 14, B-2870 C DROPS ML
SWITZERLAN LIMITED CIN/POLYMY L+6000I.U/ PUURS BELGIUM BOTTLE
D XIN B ML
2501 NDA/MAL/H PFIZER LABOREX DEPO- MEDROXYPR 150MG/ML PFIZER GLOBAL BELGIUM PARENTERAL 1.0X3.5 7/1/1997
DP/5044 LABORATORIE UGANDA PROVERA OGESTERONE MANUFACTURING ORDINARY I ML
S (PTY) LTD LIMITED ACETATE BELGIUM NV-RIJKSWEG M VIALS VIAL,1.0X
BELGIUM 12, 2870 PUURS - 1.0 ML
BELGIUM VIAL
2502 NDA/MAL/H DAR AL DAWA GAMA GIZLAN IRBESARTAN+ 150MG+12 DAR AI DAWA-NA UR JORDAN ORAL SOLID 1.0X3.0X1 7/1/2013
DP/5046 DEVELOPMEN PHARMACEUTIC PLUS HYDROCHLOR .5MG PLANT,AMMAN,JORDAN ORDINARY 0.0
T AND ALS (U) LIMITED 150/12.5 OTHIAZIDE TABLETS TABLET
INVESTMENT STRIP
CO LTD
2503 NDA/MAL/H VHB MEDI LLOYDS MAXINEM MEROPENEM 500MG VHB MEDI SCIENCES LTD- INDIA PARENTERAL 1.0X500.0 7/1/2013
DP/5047 SCIENCES LTD PHARMACY 500MG PLOT 20, 21, 22 & 49,50, ORDINARY MG VIAL
5, RUDRAPUR,
UTTARAKHAND - INDIA
2504 NDA/MAL/H VHB MEDI LLOYDS MAXINEM MEROPENEM 1G VHB MEDI SCIENCES LTD- INDIA PARENTERAL 1.0X1.0 G 7/1/2013
DP/5048 SCIENCES LTD PHARMACY 1G PLOT 20, 21, 22 & 49,50, ORDINARY VIAL
5, RUDRAPUR,
UTTARAKHAND - INDIA
2505 NDA/MAL/H DAR AL DAWA GAMA GIZLAN IRBESARTAN/ 300MG/12. DAR AI DAWA-NA UR JORDAN ORAL SOLID 1.0X3.0X1 7/1/2013
DP/5049 DEVELOPMEN PHARMACEUTIC PLUS HYDROCHLOR 5MG PLANT,AMMAN,JORDAN ORDINARY 0.0
T AND ALS (U) LIMITED 300/12.5 OTHIAZIDE FILM- TABLET
INVESTMENT COATED STRIP
CO LTD TABLETS
2506 NDA/MAL/H NORVATIS LABOREX MAXIDEX DEXAMETHAS 0.1%W/V ALCON COUVREUR NV- BELGIUM OPHTHALMI 1.0X5.0 7/1/1997
DP/5050 PHARMA AG- UGANDA ONE RIJKSWEG 14, B-2870 C DROPS ML
D
2507 NDA/MAL/H CADILA ABACUS DERIHALER SALBUTAMOL 100CMG/D CADILA HEALTHCARE LTD-- INDIA LUNG 1.0X200.0 7/1/2005
DP/5051 HEALTHCARE PHARMA OSE -SARKHEJ-PLOT ADMINISTRA METERED
LIMITED (AFRICA) 417,419,420, SARKHEJ- TION CFC- DOSE
SARKHEJ LIMITED BAVLA NH FREE CANNISTE
NO.8A,VILLAGE: MORAIYA METERED- R
AHMEDABAD 382210 INHALER
2508 NDA/MAL/H CADILA ESCORTS GLAMIDE GLIBENCLAMI 5 MG LA-MED HEALTHCARE PVT INDIA ORAL SOLID 2.0X50.0 7/1/1997
DP/5052 PHARMACEUT PHARMACEUTIC TABLETS DE LTD-1389 TRASAD ROAD, ORDINARY TABLET
ICALS LIMITED ALS LIMITED DHOLKA, AHMEDABAD, TABLETS CONTAIN
GUJARAT INDIA ER,1.0X10
00.0
TABLET
CONTAIN
ER
2509 NDA/MAL/H SANOFI SURGIPHARM MAALOX MAGNESIUM 200MG + WINTHROP SOUTH ORAL SOLID 1.0X10.0 7/1/2011
DP/5054 AVENTIS (U) LIMITED HYDROXIDE + 200MG PHARMACEUTICALS (PTY) AFRICA ORDINARY TABLET
KENYA LTD ALUMINIUM LTD.-PLOT NO.315 CHEWABLE BLISTER,1.
HYDROXIDE WALTLOO TABLETS 0X5.0X10.
ROAD,PRETORIA,0186PRE 0 TABLET
TORIA-PRIVATE BAG BLISTER
X516,SILVERTON,0127,SO
UTH AFRICA
2510 NDA/MAL/H GLAXOSMITH UNITED DERMOVAT CLOBETASOL 0.05%W/W GLAXOSMITHKLINE UNITED TOPICAL 1.0X30.0 7/1/1997
DP/5055 KLINE LTD UK HEALTHCARE E PROPIONATE HARMIRE - KINGDOM EXTERNAL G
DISTRIBUTORS GLAXOSMITHKLINE OINTMENTS TUBE,1.0X
LTD HARMIRE ROAD BARNARD 25.0 G
CASTLE DURHAM TUBE
2511 NDA/MAL/H AVENTIS SURGIPHARM MAALOX MAGNESIUM 665MG/5 WINTHROP SOUTH ORAL LIQUID1.0X350.0 7/1/1997
DP/5056 PHARMA (U) LIMITED SUSPENSIO HYDROXIDE + ML + PHARMACEUTICALS (PTY) AFRICA ORDINARY ML
(PTY) LTD N ALUMINIUM 200MG/5 LTD.-PLOT NO.315 SUSPENSION BOTTLE,1.
SOUTH HYDROXIDE ML WALTLOO S 0X150.0
AFRICA ROAD,PRETORIA,0186PRE ML
TORIA-PRIVATE BAG BOTTLE,1.
X516,SILVERTON,0127,SO 0X100.0
UTH AFRICA ML
BOTTLE,1.
0X500.0
ML
BOTTLE
2512 NDA/MAL/H SANOFI SURGIPHARM MAALOX MAGNESIUM 200MG + WINTHROP SOUTH ORAL SOLID 1.0X4.0X1 7/1/2011
DP/5057 AVENTIS (U) LIMITED PLUS HYDROXIDE + 200MG + PHARMACEUTICALS (PTY) AFRICA ORDINARY 0.0
KENYA LTD ALUMINIUM 25MG LTD.-PLOT NO.315 CHEWABLE TABLET
HYDROXIDE + WALTLOO TABLETS BLISTER
SIMETHICONE ROAD,PRETORIA,0186PRE
TORIA-PRIVATE BAG
X516,SILVERTON,0127,SO
UTH AFRICA
2513 NDA/MAL/H AVENTIS SURGIPHARM MAALOX MAGNESIUM 200MG+17 WINTHROP SOUTH ORAL LIQUID 1.0X350.0 7/1/1997
DP/5059 PHARMA (U) LIMITED PLUS HYDROXIDE + 5MG+25M PHARMACEUTICALS (PTY) AFRICA ORDINARY ML
(PTY) LTD SUSPENSIO ALUMINIUM G/5ML LTD.-PLOT NO.315 SUSPENSION BOTTLE,1.
SOUTH N HYDROXIDE+S WALTLOO S 0X150.0
AFRICA IMETHICONE ROAD,PRETORIA,0186PRE ML
TORIA-PRIVATE BAG BOTTLE,1.
X516,SILVERTON,0127,SO 0X100.0
UTH AFRICA ML
BOTTLE,1.
0X500.0
ML
BOTTLE
2514 NDA/MAL/H EUROLIFE AIVEEN (U) MANNILIFE MANNITOL 20MG/100 EUROLIFE HEALTHCARE INDIA PARENTERAL 1.0X100.0 7/1/2010
DP/5062 HEALTHCARE LIMITED ML PVT LTD-BHAGWANPUR ORDINARY ML
VIALS/BOTTL
ES
2515 NDA/MAL/H NIRMA LIFE PHARMA MANNITOL MANNITOL 20%W/V ACULIFE HEALTHCARE INDIA PARENTERAL 1.0X100.0 7/1/2011
DP/5064 LIMITED AFRICA LIMITED INFUSION PVT. LTD-VILLAGE ORDINARY ML
(HEALTHCARE SACHANA ,TALUKA - INFUSION BOTTLE
DI VISION) VIRAMGAM , VIALS/BOTTL
HEALTHCARE GUJARAT
2516 NDA/MAL/H M.J.BIOPHAR TATA UGANDA DEXAMETH DEXAMETHAS 4MG/ML M.J. BIOPHARM PVT. LTD- INDIA PARENTERAL 1.0X100.0 7/1/2015
DP/5066 M PVT LTD LIMITED ASONE ONE SODIUM L-7, M.I.D.C. , TALOJA, ORDINARY X1.0 ML
SODIUM PHOSPHATE DISTRICT RAIGAD - 410 AMPOULES AMPOULE
PHOSPHAT 208
E NAVI MUMBAI, INDIA
2517 NDA/MAL/H GITTOES GITTOES DEXAMETH DEXAMETHAS 8MG/2ML NINGBO DAHONGYING CHINA PARENTERAL 1.0X10.0X 7/1/2010
DP/5068 PHARMACEUT PHARMACEUTIC ASONE ONE SODIUM PHARMACEUTICAL CO ORDINARY 2.0 ML
ICALS LIMITED ALS LIMITED SODIUM PHOSPHATE LTD.-NO. 3986, HI-TECH AMPOULES AMPOULE
PHOSPHAT PARK MINZHU ROAD,
E NINGBO CITY, ZHEJIANG
2518 NDA/MAL/H EMCURE HARLEYS LOMOH-60 ENOXAPARIN 60MG/0.6 EMCURE INDIA PARENTERAL 1.0X1.0 7/1/2009
DP/5070 PHARMACEUT UGANDA SODIUM ML PHARMACEUTICALS LTD - ORDINARY ML PRE-
PUNE 411057
2519 NDA/MAL/H EMCURE HARLEYS LOMOH-40 ENOXAPARIN 40MG/0.4 EMCURE INDIA PARENTERAL 1.0X1.0 7/1/2009
DP/5071 PHARMACEUT UGANDA SODIUM ML PHARMACEUTICALS LTD - ORDINARY ML PRE-
PUNE 411057
2520 NDA/MAL/H CADILA ABACUS DEXONA DEXAMATHAS 0.35%W/V AHLCON PARENTERALS INDIA OPHTHALMI 1.0X5.0 7/1/1997
DP/5073 HEALTHCARE PHARMA EYE/EAR ONE SODIUM +0.1%W/V (INDIA) LTD-SP-917-918, C DROPS ML
LTD (AFRICA) DROP PHOSPHATE+ PHASE-III BHIWADI- BOTTLE,1.
LIMITED NEOMYCIN 301019, ALWAR, 0X2.5 ML
SULPHATE RAJASTHAN BOTTLE
2521 NDA/MAL/H CADILA ABACUS DEXONA DEXAMETHAS 4MG/ML SAKAR HEALTH CARE PVT INDIA PARENTERAL 1.0X6.0X2 7/1/1997
DP/5074 HEALTH CARE PHARMA INJECTION ONE LTD-10/13 CHONGODAR ORDINARY .0 ML
LTD (AFRICA) DISODIUM SARKHEJ BAVLA ROAD VIALS VIAL,16.0
LIMITED PHOSPHATE DIST AHEMABAD 382213 X6.0X2.0
GUJARATI CADILA HEALTH ML VIAL
CARE LTD-SARKHEJ BAVLA
N.H NO. 8A MORAIJA, TAL,
SANARD, AHMEDAD
382210, INDIA
2522 NDA/MAL/H CADILA ABACUS DEXONA DEXAMETHAS 0.5MG CADILA HEALTHCARE INDIA ORAL SOLID 1.0X1000. 7/1/1997
DP/5075 HEALTHCARE PHARMA TABLETS ONE LIMITED SARKHEJ- ORDINARY 0 TABLET
LTD (AFRICA) SARKHEJ-BAVLA N.H TABLETS CONTAIN
LIMITED NO.8A, N.H NO.8A, ER,1.0X10
.0X10.0
TABLET
STRIP
2523 NDA/MAL/H NABIQASIM JEET GLANDIN DINOPROSTO 3MG NABIQASIM INDUSTRIES PAKISTAN VAGINAL 1.0X1.0 7/1/2006
DP/5078 INDUSTRIES PHARMACEUTIC E2 NE (PVT) LIMITED-17/24, TABLETS TABLET
(PVT) LTD. ALS LIMITED VAGINAL KORANGI INDUSTRIAL STRIP
2524 NDA/MAL/H GENO HARLEYS LOBAK DICLOFENAC/ 50MG/325 GENO PHARMACEUTICALS INDIA ORAL SOLID 1.0X10.0 7/1/2011
DP/5080 PHARMACEUT UGANDA PARACETAM MG/250M LTD--PHARMACEUTICAL ORDINARY TABLET
ICALS PVT LTD LIMITED OL/CHLORZO G COMPLEX, TIVIM TABLETS BLISTER
XAZONE INDUSTRIAL ESTATE, P.O.
KARASWADA, MAPUSA,
GOA 403526
2525 NDA/MAL/H PHARCO WIDE DIABEN GLIBENCLAMI 5MG PHARCO EGYPT ORAL SOLID 1.0X2.0X1 7/1/1998
DP/5087 PHARMACEUT SPECTRUM TABLETS DE PHARMACEUTICALS LTD- ORDINARY 0.0
ICALS ENTERPRISES KILO 31 ALEXANDRIA, TABLETS TABLET
ALEXANDRIA EGYPT
2526 NDA/MAL/H MICRO LABS PHILLIPS DIAPRIDE GLIMEPIRIDE 2MG MICRO LABS LTD-92, INDIA ORAL SOLID 1.0X3.0X1 7/1/2011
DP/5092 LTD 92 PHARMACEUTIC SIPCOT INDUSTRIAL ORDINARY 0.0
SIPCOT ALS (UGANDA) COMPLEX HOSU R-635126 TABLETS TABLET
2527 NDA/MAL/H DAR AL DAWA GAMA LIPODAR 10 ATORVASTATI 10MG DAR AI DAWA-NA UR JORDAN ORAL SOLID 1.0X3.0X1 7/1/2011
DP/5093 DEVELOPMEN PHARMACEUTIC N PLANT,AMMAN,JORDAN ORDINARY 0.0
CO LTD TABLETS
2528 NDA/MAL/H MICRO LABS LABOREX DIAPRIDE GLIMEPIRIDE 1MG + MICRO LABS LTD 92 INDIA ORAL SOLID 1.0X3.0X1 7/1/2013
DP/5095 LTD UGANDA PLUS + 500MG SIPCOT -92 SIPCOT ORDINARY 0.0
LIMITED METFORMIN HOSUR 635 126 TAMIL TABLETS TABLET
NADU BLISTER
2529 NDA/MAL/H ATCO HARLEYS SCABION CROTAMITON 10 G + ATCO LABS LTD,-B-18, INDIA TOPICAL 1.0X60.0 7/1/2003
DP/5096 LABORATORIE UGANDA + SULPHUR 2G/100G S.I.T.E, KARACHI EXTERNAL ML
S LTD LIMITED OINTMENTS BOTTLE
2530 NDA/MAL/H EUROLIFE AIVEEN (U) GLUCOLIFE GLUCOSE 50%W/V EUROLIFE HEALTHCARE INDIA PARENTERAL 1.0X100.0 7/1/2010
DP/5097 HEALTHCARE LIMITED PVT LTD-BHAGWANPUR ORDINARY ML
VIALS/BOTTL
ES
2531 NDA/MAL/H RIVA WIDE DIARIV DI-IODO 125MG/ RIVA PHARMA FREE ZONE- EGYPT ORAL LIQUID 1.0X60.0 7/1/2011
DP/5098 PHARMA SPECTRUM HYDROXYQUI 150MG/ NASR CITY CAIRO EGYPT ORDINARY ML
FREE ZONE ENTERPRISES NOLINE/ 1MG/ DRY BOTTLE
(U) LIMITED PHTHALYL 100MG SUSPENSION
SULPHATHIAZ S/SYRUPS/D
OLE/ ROPS
HOMATROPI
NE /
STREPTOMYC
IN
2532 NDA/MAL/H COSMOS LTD ASTRA PHARMA GLUCOMET METFORMIN 500MG COSMOS LIMITED-- KENYA ORAL SOLID 1.0X3.0X1 7/1/2005
DP/5099 (U) LIMITED RANGWA ROAD, OFF ORDINARY 0.0
INDUSTRIAL AREA 0X2.0X14.
0 TABLET
BLISTER,1.
0X4.0X14.
0 TABLET
BLISTER
2533 NDA/MAL/H LINCOLN METRO L-GENTA GENTAMICIN 0.3%W/V LINCOLN INDIA OPHTHALMI 1.0X10.0 7/1/2005
DP/5100 PHARMACEUT PHARMACEUTIC PHARMACEUTICALS LTD-- C DROPS ML VIAL
ICALS LTD ALS LIMITED TRIMUL ESTATE AFER
VODSAR VILLAGE KHATJAT
GANDHINAGAR INDIA
2534 NDA/MAL/H MERCK (PTY) UNITED GLUCOPHA METFORMIN 500MG MERCK SANTÉ-2, RUE DU FRANCE ORAL SOLID 1.0X500.0 7/1/2010
DP/5102 LTD HEALTHCARE GE 500MG PRESSOIR VERT F 45400, ORDINARY TABLET
DISTRIBUTORS SEMOY NKUNZI FILM- CONTAIN
LTD PHARMACEUTICALS (PTY) COATED ER,1.0X6.
LTD.-259 DAVIDSON ROAD TABLETS 0X15.0
CNR PEDDIE STREET, TABLET
WADEVILLE EST. 1 BLISTER,1.
GERMISTON 1422 0X30.0
TABLET
BLISTER
2535 NDA/MAL/H MERCK (PTY) UNITED GLUCOPHA METFORMIN 1000MG NKUNZI FRANCE ORAL SOLID 1.0X4.0X1 7/1/2010
DP/5103 LTD HEALTHCARE GE 1000MG PHARMACEUTICALS (PTY) ORDINARY 5.0
DISTRIBUTORS LTD --259 DAVIDSON FILM- TABLET
LTD ROAD, WADEVILLE, EXT 1, COATED BLISTER
GERMINSTON, SOUTH TABLETS
AFRICA
2536 NDA/MAL/H NOVO PHILLIPS LEVEMIR INSULIN 100 I.U/ML NOVO NORDISK A/S - DENMARK PARENTERAL 1.0X5.0X3 7/1/2014
DP/5104 NORDISK PHARMACEUTIC FLEXPEN DETEMIR NOVO ALLE DK-2880 ORDINARY .0 ML
PHARMA ALS (UGANDA) BAGSVAERD PRE-FILLED PREFILLED
GULF FZ-LC LIMITED PENS PEN
2537 NDA/MAL/H ESAPHARM BYAMAKA LEMONVAT CLOBETASOL 0.05%W/W ESAPHARMA SRL-VIA DE ITALY TOPICAL 1.0X30.0 7/1/2003
DP/5106 SRL PHARMACEUTIC E CREAM PROPIONATE GASPERI, 13-20066 MELZO EXTERNAL G TUBE
AL COMPANY (MILAN) ITALY CREAMS
LTD
2538 NDA/MAL/H RENE RENE INDOREN INDOMETHAC 25MG RENE INDUSTRIES LTD- UGANDA ORAL SOLID 10.0X10.0 7/1/2000
DP/5107 INDUSTRIES INDUSTRIES CAPSULES IN PLOT 680, KAMULI ROAD, ORDINARY CAPSULE
LTD LIMITED KIREKA, P.O BOX 6034, CAPSULES BLISTER,1.
KAMPALA 0X1000.0
CAPSULE
CONTAIN
ER
2539 NDA/MAL/H LEBEN ANDYCO LEBASMA SALBUTAMOL 2MG/5ML LEBEN LAB PVT LTD-L4 INDIA ORAL LIQUID 1.0X100.0 7/1/2011
DP/5109 LABORATORIE PHARMACY ORAL PHASE 111 MIDCS AKOLA ORDINARY ML
S PVT LTD (UGANDA) LTD SOLUTION 444104 MAHARASTRA SYRUPS BOTTLE
INDIA
2540 NDA/MAL/H NIRMA LIFE PHARMA GLUCOSE DEXTROSE 5%W/V ACULIFE HEALTHCARE INDIA PARENTERAL 1.0X250.0 7/1/1997
DP/5110 LIMITED. AFRICA LIMITED INFUSION PVT. LTD-VILLAGE ORDINARY ML
BP SACHANA ,TALUKA - INFUSION BOTTLE,1.
VIRAMGAM , VIALS/BOTTL 0X500.0
AHMEDABAD 382150 ES ML
GUJARAT BOTTLE
2541 NDA/MAL/H WIN- SURGIPHARM DICLOMOL DICLOFENAC 100MG WIN MEDICARE PVT INDIA ORAL SOLID 1.0X10.0X 7/1/1998
DP/5112 MEDICARE (U) LIMITED SR TABLETS SODIUM LIMITED-MEERUT, RETARD 10.0
PVT LTD MUZAFFARNAGER ROAD, TABLETS TABLET
UTTAR PRADESH -INDIA
2542 NDA/MAL/H SHOSAAN RENE LATONE MULTIVITAMI MULTI- NEM LABORATORIES PVT INDIA ORAL SOLID 1.0X10.0X 7/1/2009
DP/5114 ASIC PACIFIC PHARMACY LTD MULTIVITA N INGREDIEN LTD-NEM LABORATORIES ORDINARY 10.0
MIN T PVT LTD, 133 VASAI RD(E) TABLETS TABLET
401 162 SB MARG. LOWER BLISTER,1.
PAREL MUMBAI 0X3.0X10.
0 TABLET
BLISTER
2543 NDA/MAL/H GITTOES GITTOES INDOS-25 INDOMETHAC 25MG AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1000.0 7/1/2000
DP/5115 PHARMACEUT PHARMACEUTIC IN NO.33,SECTOR ORDINARY CAPSULE
ICALS LIMITED ALS LIMITED II,VASAI,TALUKA INDL CO- CAPSULES CONTAIN
PADA,VASAI(E)DIST.THAN .0
E INDIA CAPSULE
BLISTER,1.
0X10.0X10
.0
CAPSULE
BLISTER
2544 NDA/MAL/H VENUS HARLEYS LASTINEM IMIPENEM + 500MG + VENUS REMMEDIES-UNIT INDIA PARENTERAL 1.0X10.0 7/1/2011
DP/5117 REMEDIES UGANDA CILASTATIN 500MG II HILLTOP INDUSTRIAL ORDINARY ML VIAL
LIMITED LIMITED ESTATES JHARMAJRI EPIP DRY VIALS
PHASE 1 BHOTOLI KALA
BADDI INDIA
2545 NDA/MAL/H REMEDICA GOODMAN GLYFORMI METFORMIN 500MG REMEDICA LIMITED- CYPRUS ORAL SOLID 1.0X10.0X 7/1/1999
DP/5120 LTD INTERNATIONAL N 500 LIMASSOL INDUSTRIAL ORDINARY 10.0
BLISTER,1.
0X500.0
TABLET
CONTAIN
ER
2546 NDA/MAL/H UNIQUE TATA UGANDA DICLORAN DICLOFENAC 1%W/W UNIQUE INDIA TOPICAL 1.0X50.0 7/1/1997
DP/5121 PHARMACEUT LIMITED GEL DIETHYLAMM PHARMACEUTICALS LABS ( EXTERNAL G
ICALS ONIUM A DIV OF J.B CHEMICALS & GELS AND TUBE,1.0X
LABORATORIE PHARMACEUTICAL LTD)-- SOLS 20.0 G
S 304-308 ,GIDC , PANOLI TUBE
394116
2547 NDA/MAL/H CENTAUR GITTOES KOFAREST SALBUTAMOL 2MG+30M CENTAUR INDIA ORAL LIQUID 1.0X100.0 7/1/2007
DP/5122 PHARMACEUT PHARMACEUTIC SYRUP SULPHATE/A G+100MG+ PHARMACEUTICALS LTD- ORDINARY ML
ICALS LTD ALS LIMITED MBROXOL 5MG/10ML PLOT NO.3 TIVIN SYRUPS BOTTLE,1.
SULPHATE/G INDUSTRIAL ESTATE 0X60.0 ML
UAFENESIN/ KARASWADA 403526 BOTTLE
MENTHOL INDIA
2548 NDA/MAL/H GLAXOSMITH UNITED INFANRIX- DIPHTHERIA MIN 30 GLAXOSMITHKLINE BELGIUM PARENTERAL 1.0X1.0 7/1/2013
DP/5124 KLINE LTD HEALTHCARE HEXA TOXOID+TETA I.U+MIN 40 BOILOGICALS-S.A RUE DE ORDINARY PACK
BELGIUM DISTRIBUTORS NUS I.U+25ΜG+ I'INSTITUT 89 B-1330 COMBINATI CARTON
LTD TOXOID+PERT 25ΜG+8Μ RIXENSART ON PACK (DTPA-
USSIS G+10ΜG,4 VIALS HBV-IPV
TOXOID(PT)+ 0DU+8DU+ IN
FILAMENTOU 32DU+10Μ PREFILLED
S G SYRINGE +
HAEMAGGLU 2
TININ(FHA)+P NEEDLES+
ERTACTIN(69 FREEZE
KDA DRIED HIB
2549 NDA/MAL/H MACK SHURIK LTD GLYGESIC MULTI N/A TORQUE INDIA TOPICAL 1.0X15.0 7/1/1998
DP/5125 BROWN FORTE INGREDIENT PHARMACEUTICALS LTD - EXTERNAL G TUBE
PHARMECEUT RHUMETIC ISSAPUR P.O DAPPAR CREAMS
ICALS PVT LTD CREAM 140506
2550 NDA/MAL/H UNIVERSAL DELMAW KNAC-75 DICLOFENAC 75MG UNIVERSAL CORPORATION KENYA ORAL SOLID 1.0X3.0X1 7/1/2011
DP/5126 CORPORATIO ENTERPRISES LIMITED -PLOT 13777 ORDINARY 0.0
N LTD LIMITED KIKUYU ROAD, KIKUYU FILM- TABLET
TOWN, PAST POST OFFICE COATED BLISTER
TABLETS
2551 NDA/MAL/H UNIQUE PLANET DICLORAN DICLOFENAC 25MG/ML UNIQUE INDIA PARENTERAL 1.0X100.0 7/1/1997
DP/5127 PHARMACEUT PHARMACEUTIC INJECTION SODIUM PHARMACEUTICALS LABS ( ORDINARY X3.0 ML
ICALS ALS UGANDA A DIV OF J.B CHEMICALS & AMPOULES AMPOULE
LABORATORIE LTD PHARMACEUTICAL LTD)-- ,1.0X5.0X3
S 304-308 ,GIDC , PANOLI .0 ML
394116 AMPOULE
2552 NDA/MAL/H MEDIPHARM ABACUS GOFEN 400 IBUPROFEN 400MG MEGA LIFESCIENCES LTD.- THAILAND ORAL SOLID 6.0X1.0X1 7/1/2009
DP/5128 SALES LTD PHARMA CLEARCAP 384 PATTANA 3 ROAD ORDINARY 0.0
(AFRICA) BANGPOO INDUSTRIAL CAPSULES CAPSULE
LIMITED ESTATE SUMUTPRAKAN BLISTER
2553 NDA/MAL/H NABIQASIM JEET KLEEN DISODIUM 19.2G+7.2 NABIQASIM INDUSTRIES PAKISTAN RECTAL 1.0X135.0 7/1/2006
DP/5129 INDUSTRIES PHARMACEUTIC ENEMA BISPHOSPHAT G/ 120ML (PVT) LIMITED-17/24, SYSTEMIC ML
(PVT) LTD. ALS LIMITED E/ SODIUM KORANGI INDUSTRIAL ENEMA BOTTLE
PHOSPHATE AREA, KARACHI, PAKISTAN LIQUIDS
2554 NDA/MAL/H UNIQUE TATA UGANDA DICLORAN DICLOFENAC+ 1%W/W+1 UNIQUE INDIA TOPICAL 1.0X30.0 7/1/2005
DP/5130 PHARMACEUT LIMITED MS GEL METHYL 0%W/W+5 PHARMACEUTICALS LABS ( EXTERNAL G TUBE
ICALS LTD SALICYLATE+ %W/W A DIV OF J.B CHEMICALS & GELS AND
MENTHOL PHARMACEUTICAL LTD)-- SOLS
304-308 ,GIDC , PANOLI
394116
2555 NDA/MAL/H NOVO STAR INSULATAR ISOPHANE 100 I.U/ML NOVO NORDISK PHARMA- DENMARK PARENTERAL 1.0X10.0 7/1/1997
DP/5131 NORDISK PHARMACEUTIC D INSULIN NOVO ALLE ORDINARY S ML VIAL
ALS LTD (HUMAN) C VIALS
2556 NDA/MAL/H REMEDICA GOODMAN KETROZOL KETOCONAZO 200MG REMEDICA LIMITED,- CYPRUS ORAL SOLID 10.0X10.0 7/1/1997
DP/5132 LTD INTERNATIONAL 200 LE LIMASSOL INDUSTRIAL ORDINARY TABLET
LTD TABLETS ESTATE, AHARNON ST, TABLETS BLISTER
P.O. BOX 51706,3508
LIMASSOL
2557 NDA/MAL/H MERCK (PTY) UNITED GONAL-F FOLLITROPIN 66MCG/1.5 MERCK SERONO S.A. SWITZERLAN PARENTERAL 1.0X1.0 7/1/2015
DP/5133 LTD HEALTHCARE PEN ALFA ML (MSA) -1170 SUCCURSALE D ORDINARY CARTRIDG
DISTRIBUTORS 900IU/1.5M D’AUBONNE ZONE PRE-FILLED E
LTD L(66MCG/1. INDUSTRIELLE DE PENS PREFILLED
5ML) L’OURIETTAZ, PEN + 20
SWITZERLAND NEEDLES
FOR
INJECTIO
N,1.0X1.0
CARTRIDG
E
PREFILLED
2558 NDA/MAL/H BETA BETA GOODMOR MULTIINGRE N/A BETA HEALTHCARE KENYA ORAL SOLID 1.0X100.0 7/1/1997
DP/5134 HEALTHCARE HEALTHCARE NING DIENT INTERNATIONAL LTD - - ORDINARY TABLET
UGANDA UGANDA COUGH PLOT TABLETS CARTON
LIMITED LIMITED TABLETS NO.209/6554,MOGADISHU
INDUSTRIAL AREA,
P.O.BOX 42569-001000
NAIROBI,KENYA
2559 NDA/MAL/H S K AGE ABACUS KETOZ KETOCONAZO 2%W/W SK ANT HEALTHCARE LTD- INDIA TOPICAL 1.0X15.0 7/1/2010
DP/5135 EXPORTS PHARMA LE 1802-1805 GIDC PHASE III, EXTERNAL G
(AFRICA) VAPI-396195 GUJARAT, CREAMS TUBE,1.0X
LIMITED INDIA 30.0 G
TUBE
2560 NDA/MAL/H BETA BETA GOODMOR MULTIINGRE N/A BETA HEALTHCARE KENYA ORAL LIQUID 1.0X60.0 7/1/1997
DP/5136 HEALTHCARE HEALTHCARE NING LUNG DIENT INTERNATIONAL LTD - - ORDINARY ML
INTERNATION UGANDA TONIC PLOT SYRUPS BOTTLE,1.
AL LTD LIMITED NO.209/6554,MOGADISHU 0X50.0 ML
INDUSTRIAL AREA,
P.O.BOX 42569-001000
NAIROBI,KENYA
2561 NDA/MAL/H RENE RENE KETOREN KETOCONAZO 200MG RENE INDUSTRIES LTD- UGANDA ORAL SOLID 1.0X3.0X1 7/1/2010
DP/5137 INDUSTRIES INDUSTRIES LE PLOT 680, KAMULI ROAD, ORDINARY 0.0
KAMPALA BLISTER,1.
0X10.0X10
.0 TABLET
BLISTER
2562 NDA/MAL/H NOVO STAR INSULATAR ISOPHANE 100I.U/ML NOVO NORDISK PHARMA- DENMARK PARENTERAL 1.0X1.5 7/1/1997
DP/5139 NORDISK PHARMACEUTIC D HM INSULIN NOVO ALLE ORDINARY ML
ALS LTD PENFILL (HUMAN) PRE-FILLED CARTRIDG
PENS E,1.0X3.0
ML
CARTRIDG
E
2563 NDA/MAL/H PFIZER LABOREX DIFLUCAN FLUCONAZOL 200MG FAREVA AMBOISE - -ZONE FRANCE ORAL SOLID 1.0X7.0 7/1/1997
DP/5140 LABORATORIE UGANDA E INDUSTRIELLE, 29 ROUTE ORDINARY CAPSULE
S PTY LTD LIMITED DES INDUSTRIES, 37530 CAPSULES BLISTER
POCE SUR CISSE, FRANCE
2564 NDA/MAL/H MACK SHURIK LTD KETOMAC KETOCONAZO 2%W/V TORQUE INDIA TOPICAL 75.0 ML 7/1/2003
DP/5141 BROWN SHAMPOO LE PHARMACEUTICALS LTD - EXTERNAL BOTTLE
PHARMECEUT ISSAPUR P.O DAPPAR LIQUID
ICALS PVT LTD 140506 SOAPS/WAS
HES
2565 NDA/MAL/H REGAL REGAL PHARMA INTAMINE MEPYRAMINE 2%W/W REGAL KENYA TOPICAL 1.0X25.0 7/1/1997
DP/5142 PHARMACEUI (U) LTD CREAM MALEATE PHARMACEUTICALS LTD- EXTERNAL G
CALS LTD BABA DOGO ROAD, CREAMS TUBE,1.0X
RAURAKA,NAIROBI,KENYA 400.0 G
TUBE
2566 NDA/MAL/H ASTRA MACNAUGHTON BETALOC METOPROLOL 25MG ASTRA ZENECA AB- SWEDEN ORAL SOLID 1.0X1.0X1 7/1/2011
DP/5143 ZENECA LIMITED ZOK - 25MG GARTUNAVGEN SE 151 58 ORDINARY 4.0
SODAERTAJJE SWEDEN TABLETS TABLET
BLISTER
2567 NDA/MAL/H HOVID BHD UNITED KETOCONA KETOCONAZO 200MG HOVID BHD-LOT 56442, MALAYSIA ORAL SOLID 1.0X10.0X 7/1/2008
DP/5144 HEALTHCARE ZOLE LE 7.5 MILE JALAN ORDINARY 10.0
DISTRIBUTORS 200MG IPOH/CHEMO 31200 TABLETS TABLET
MALAYSIA
2568 NDA/MAL/H ASTRA MACNAUGHTON BETALOC METOPROLOL 100MG ASTRA ZENECA AB-SE-151 SWEDEN ORAL SOLID 1.0X30.0 7/1/2011
DP/5146 ZENECA LIMITED ZOK - 85 SODERTALJE, SWEDEN ORDINARY TABLET
100MG (GARTUNAVAGEN & TABLETS CONTAIN
SNACKVIKEN) ER
2569 NDA/MAL/H ASTRA MACNAUGHTON BETALOC METOPROLOL 50MG ASTRA ZENECA AB- SWEDEN ORAL SOLID 1.0X30.0 7/1/2011
DP/5147 ZENECA LIMITED ZOK - 50MG GARTUNAVGEN SE 151 58 ORDINARY TABLET
SODAERTAJJE SWEDEN TABLETS CONTAIN
ER
2570 NDA/MAL/H CADILA ABACUS BETANASE GLIBENCLAMI 5MG CADILA HEALTHCARE INDIA ORAL SOLID 1.0X10.0X 7/1/1997
DP/5148 HEALTHCARE PHARMA TABLETS DE LIMITED--KUNDAIM ORDINARY 10.0
LTD (AFRICA) INDUSTRIAL ESTATE, PLOT TABLETS TABLET
KUNDAIM,GOA-403 115, 0X5.0X3.0
INDIA X10.0
TABLET
BLISTER,1.
0X1000.0
TABLET
CONTAIN
ER,1.0X2.
2571 NDA/MAL/H GLENMARK STAR KETO PLUS KETOCONAZO 1%W/V+2 GLENMARK INDIA TOPICAL 60.0 ML 7/1/2003
DP/5150 PHARMACUTI PHARMACEUTIC SHAMPOO LE/ZINC %W/V PHARMACEUTICALS LTD- EXTERNAL BOTTLE
CALS LTD ALS LTD PYRITHIONE PLOT NO E -37, 39 ,D LIQUID
SOAPS/WAS
HES
2572 NDA/MAL/H SOLVAY HARLEYS BETASERC BETAHISTINE 8MG SOLVAY NETHERLAND ORAL SOLID 4.0X25.0 7/1/2001
DP/5151 PHARMACEUT UGANDA PHARMACEUTICALS - S ORDINARY TABLET
ICALS BV LIMITED VEERWENG TABLETS BLISTER
12,8121AA,DIST. THE
NETHERLANDS
2573 NDA/MAL/H BETA BETA BETASIL IPECACUANH 0.5ML BETA HEALTHCARE KENYA ORAL LIQUID 1.0X50.0 7/1/1997
DP/5154 HEALTHCARE HEALTHCARE PAEDIATRIC A TINCTURE INTERNATIONAL LTD - - ORDINARY ML
UGANDA UGANDA SYRUP PLOT SYRUPS BOTTLE,1.
LIMITED LIMITED NO.209/6554,MOGADISHU 0X60.0 ML
INDUSTRIAL AREA,
P.O.BOX 42569-001000
NAIROBI,KENYA
2574 NDA/MAL/H SHOSAAN RENE BETAVEL MULTI- N/A NEM LABORATORIES PVT INDIA TOPICAL 1.0X15.0 7/1/1997
DP/5155 ASIC PACIFIC PHARMACY LTD INGREDIENT LTD-133 VASAI RD(E) 401 EXTERNAL G TUBE
PAREL MUMBAI
2575 NDA/MAL/H SHOSAAN RENE BETAVEL N BETAMETHAS 1MG+5MG NEM LABORATORIES PVT INDIA TOPICAL 1.0X3.0 G 7/1/1997
DP/5157 ASIC PACIFIC PHARMACY LTD ONE+NEOMY LTD-133 VASAI RD(E) 401 EXTERNAL TUBE,1.0X
CIN 162 SB MARG. LOWER CREAMS 15.0 G
SULPHATE PAREL MUMBAI TUBE
2576 NDA/MAL/H NIRMA LIFE PHARMA KETANIR KETAMINE 50MG/ML NIRMA LIMITED INDIA PARENTERAL 1.0X1.0X1 7/1/2012
DP/5158 LIMITED. AFRICA LIMITED (HEALTHCARE DIVISION)- ORDINARY 0.0 ML
VILLAGE-SACHANA, VIALS VIAL
TALUKA-VIRAMGAM
DISTRICT- AHMEDABAD
382 150, GUJARAT, INDIA
2577 NDA/MAL/H AFRICURE ROYAL PHARMA GRISEOSIM- GRISEOFULVI 500MG AFRICURE INDIA ORAL SOLID 1.0X10.0X 7/1/2005
DP/5161 PHARMACEUT 2011 LIMITED 500 N PHARMACEUTICALS ORDINARY 10.0
ICALS (INDIA) (INDIA) PRIVATE LIMITED TABLETS TABLET
PRIVATELIMIT (755793)-PLOT 9- BLISTER
ED 12,DEWAN & SONS
INDUSTRIAL. AREA,
VEOOR,PALGHAR-401404.
INDIA.
2578 NDA/MAL/H VENUS AARON IRINOL IRINOTECAN 20MG/ML VENUS REMEDIES LTD, INDIA PARENTERAL 1.0X2.0 7/1/2009
DP/5162 REMIDIES LTD PHARMACEUTIC HYDROCHLOR UNIT II,-HILL TOP ORDINARY I ML VIAL
ALS LTD IDE INDUSTRIAL ESTATE, V VIALS
TRIHYDRATE JHARMAJTI, EPIP, PHASE-1
KALAN, BADDI -HP
2579 NDA/MAL/H COSMOS LTD ASTRA PHARMA BROMSAL SALBUTAMOL 1MG+2MG COSMOS LTD.-RANGWE KENYA ORAL LIQUID 1.0X100.0 7/1/2010
DP/5164 (U) LIMITED EXPECTORA SULPHATE+B +50MG+0. ROAD; OFF LUNGA LUNGA ORDINARY ML
NT ROMHEXINE 5MG ROAD. P.O BOX 414 33, SYRUPS BOTTLE
HYDROCHLOR NAIROBI
IDE+GUAIFEN
ESIN+MENTH
OL
2580 NDA/MAL/H REMEDICA GOODMAN GRISEOFUL GRISEOFULVI 500MG REMEDICA LIMITED- CYPRUS ORAL SOLID 1.0X10.0X 7/1/2003
DP/5165 LTD INTERNATIONAL VIN 500 N LIMASSOL INDUSTRIAL ORDINARY 10.0
BLISTER,1.
0X100.0
TABLET
CONTAIN
ER
2581 NDA/MAL/H UMEDICA VITACARE KETAMINE KETAMINE 50MG/ML UMEDICA LABORATORIES INDIA PARENTERAL 1.0X10.0 7/1/2004
DP/5166 LABORATORIE LIMITED HYDROCHL HYDROCHLOR PVT LTD-PLOT NO. 221, ORDINARY ML VIAL
S PVT LTD ORIDE IDE 2ND PHASE, GIDC, VAPI VIALS
396195, GUJARAT. INDIA.
2582 NDA/MAL/H SUN STAR BRUSTAN IBUPROFEN + 400MG + SUN PHARMACEUTICALS INDIA ORAL SOLID 1.0X10.0 7/1/1998
DP/5167 PHARMACEUT PHARMACEUTIC TABLETS PARACETAM 300MG IND. LTD-B-2,MADAKAI ORDINARY TABLET
ICAL ALS LTD OL INDUSTRIAL ESTATE, TABLETS BLISTER
INDUSTRIES PONDA,GOA-403404,
LIMITED INDIA
2583 NDA/MAL/H GLENMARK STAR CANDITRAL ITRACONAZO 100MG GLENMARK INDIA ORAL SOLID 1.0X4.0 7/1/2000
DP/5170 PHARMACEUT PHARMACEUTIC CAPSULE LE PHARMACEUTICALS LTD- ORDINARY CAPSULE
ICAL LTD ALS LTD PLOT NO E -37, 39 ,D CAPSULES STRIP
2584 NDA/MAL/H TROIKAA ABACUS KETAMAX- KETAMINE 50MG/ML TROIKAA INDIA PARENTERAL 1.0X10.0 7/1/2011
DP/5171 PHARMACEUT PHARMA 50 PHARMACUETICALS ORDINARY ML VIAL
ICALS LIMITED (AFRICA) LIMITED-C-1 SARA VIALS
LIMITED INDUSTRIAL ESTATE,
SELAQUI, DEHRADUN-
248197, UTTARAKHAND,
INDIA
2585 NDA/MAL/H BAYER AG SURGIPHARM CANESTEN CLOTRIMAZO 1%W/V BAYER AG-D-51368 GERMANY TOPICAL 1.0X20.0 7/1/1997
DP/5174 (U) LIMITED CREAM LE LEVERKUSEN GERMANY EXTERNAL G TUBE
CREAMS
2586 NDA/MAL/H JASSEN-CILAG LABOREX GYNO- MICONAZOLE 20MG/G SPECPHARM HOLDINGS- SOUTH VAGINAL 1.0X40.0 7/1/1997
DP/5175 (PTY) LTD UGANDA DAKTARIN NITRATE 15TH ROAD HALFWAY AFRICA CREAMS G TUBE
LIMITED HOUSE
2587 NDA/MAL/H BAYER AG SURGIPHARM CANESTEN CLOTRIMAZO 100MG BAYER AG -D-51368 GERMANY VAGINAL 1.0X6.0 7/1/1997
DP/5176 (U) LIMITED LE LEVERKUSEN GERMANY TABLETS TABLET
STRIP
2588 NDA/MAL/H VHB MEDI LLOYDS CARBOTEE CARBOPLATI 450 MG / VHB MEDI SCIENCES LTD- INDIA PARENTERAL 1.0X50.0 7/1/2014
DP/5178 SCIENCES LTD PHARMACY N N 45 ML PLOT 20, 21, 22 & 49,50, ORDINARY ML VIAL
5, RUDRAPUR,
UTTARAKHAND - INDIA
2589 NDA/MAL/H PHARMA OMAB UGANDA CEFIX CEFIXIME 200MG PHARMA INTERNATIONAL JORDAN ORAL SOLID 1.0X1.0X8 7/1/2007
DP/5179 INTERNATION LIMITED 200MG TRIHYDRATE CO.,-AL-QASTAL AREA, ORDINARY .0
AL CO CAPSULES AIRPORT ROAD, 11941, CAPSULES CAPSULE
AMMAN BLISTER
2590 NDA/MAL/H REGAL REGAL PHARMA ISORYN EPHEDRINE 5MG/ML REGAL KENYA NASAL 1.0X15.0 7/1/1997
DP/5180 PHARMACEUI (U) LTD DROPS ( HYDROCHLOR PHARMACEUTICALS LTD- TOPICAL ML
CALS LTD PAEDRIATRI IDE BABA DOGO ROAD, DROPS BOTTLE
C) RAURAKA,NAIROBI,KENYA
2591 NDA/MAL/H REGAL REGAL PHARMA ISORYN EPHEDRINE 10MG/ML REGAL KENYA NASAL 1.0X15.0 7/1/1997
DP/5182 PHARMACEUI (U) LTD DROPS HYDROCHLOR PHARMACEUTICALS LTD- TOPICAL ML
CALS LTD (ADULT) IDE BABA DOGO ROAD, DROPS BOTTLE
2592 NDA/MAL/H PHARCO B WIDE GYNOZOL MICONAZOLE 400MG PHARCO EGYPT VAGINAL 1.0X3.0 7/1/2000
DP/5183 PHARMACEUT SPECTRUM VAGINAL NITRATE PHARMACEUTICALS LTD- SUPPOSITORI CAPSULE
ICALS ENTERPRISES CAPSULES KILO 31 ALEXANDRIA, ES BLISTER
ALEXANDRIA EGYPT
2593 NDA/MAL/H PHARCO WIDE GYNOZOL MICONAZOLE 2%W/W PHARCO EGYPT VAGINAL 1.0X40.0 7/1/2000
DP/5184 PHARMACEUT SPECTRUM VAGINAL NITRATE PHARMACEUTICALS LTD- CREAMS G TUBE
ICALS ENTERPRISES CREAM KILO 31 ALEXANDRIA,
ALEXANDRIA EGYPT
2594 NDA/MAL/H TROIKAA ABACUS ISOTROY ISOFLURANE 250ML TROIKAA INDIA OTHER 1.0X250.0 7/1/2014
DP/5186 PHARMACEUT PHARMA 250 PHARMACEUTICALS LTD- SYSTEMIC ML
ICALS LIMITED (AFRICA) THOL VILLAGE, DIST. LIQUID BOTTLE
LIMITED MEHSANA- 382728, INHALATION
GUJARAT, INDIA S
2595 NDA/MAL/H ATCO HARLEYS HEALIT BACITRACIN+ 500UNITS+ ATCO LABORATORIES PVT PAKISTAN TOPICAL 1.0X10.0 7/1/2007
DP/5187 LABORATORIE UGANDA SKIN POLYMYXIN B 5000UNITS LTD-B-18,S.I.T.E KARACHI, EXTERNAL G TUBE
S LTD LIMITED OINTMENT SO4+NEOMYC +3.5MG+4 PAKISTAN OINTMENTS
IN+LIDOCAIN 0MG/G
E
2596 NDA/MAL/H GITTOES GITTOES ITRAZ ITRACONAZO 100MG AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1.0X3.0X5 7/1/2009
DP/5188 PHARMACEUT PHARMACEUTIC CAPSULES LE NO.33,SECTOR ORDINARY .0
PADA,VASAI(E)DIST.THAN 0X6.0X10.
E INDIA 0
CAPSULE
BLISTER
2597 NDA/MAL/H TRIVENI AIVEEN (U) HEMOZEBE FERROUS 300MG+10 TRIVENI FORMULATIONS INDIA ORAL SOLID 1.0X3.0X1 7/1/2014
DP/5189 FORMULATIO LIMITED X SULPHATE+F 00MCG+1. LIMITED --PLOT NO 52- ORDINARY 0.0
NS LIMITED OLIC 5MG+7.5M 54,62-64 ALEAP TABLETS TABLET
ACID+PYRIDO G+61.8MG INDUSTRIAL ESTATE BLISTER
XINE SURAMPALLI (V)
HCL+CYANOC VIJAYAWADA A.P
OBALAMIN+ZI
NC SULPHATE
2598 NDA/MAL/H LABORATORY HARLEYS HYCORUM HYDROCORTI 1%W/W LABORATORY & ALLIED KENYA TOPICAL 1.0X15.0 7/1/1997
DP/5199 AND ALLIED UGANDA OINTMENT SONE LTD--PLOT NO. 209/ EXTERNAL G TUBE
LTD LIMITED 10349, OPP. SAMEER OINTMENTS
BUSINESS PARK,
MOMBASA ROAD P.O.
BOX 42875, GPO 00100,
NAIROBI, KENYA
2599 NDA/MAL/H COSMOS LTD ASTRA PHARMA HYDRALAZI HYDRALAZINE 25MG COSMOS LIMITED-- KENYA ORAL SOLID 1.0X100.0 7/1/1998
DP/5200 (U) LIMITED NE TABLETS HYDROCHLOR RANGWA ROAD, OFF ORDINARY TABLET
B.P 25MG. IDE LUNGA LUNGA ROAD,P.O TABLETS CONTAIN
INDUSTRIAL AREA 00.0
TABLET
CONTAIN
ER,1.0X10
.0X10.0
TABLET
BLISTER
2600 NDA/MAL/H KAMPALA KAMPALA KAM MEBENDAZOL 100MG KAMPALA UGANDA ORAL SOLID 1.0X100.0 7/1/1997
DP/5201 PHARMACEUT PHARMACEUTIC BENDAZOL E PHARMECEUTICALS ORDINARY X10.0
ICAL AL INDUSTRIES E INDUSTRIES LTD.-PLOT CHEWABLE TABLET
INDUSTRIES 1996 LIMITED M444B STRETCHER RD, TABLETS BLISTER,1.
LTD NTINDA KLA UGANDA 0X250.0
TABLET
CONTAIN
ER,1.0X50
0.0
TABLET
CONTAIN
ER,1.0X10
2601 NDA/MAL/H CIPLA QUALITY HYDROCOR HYDROCORTI 100MG CIPLA LTD.- -PLOT NO INDIA PARENTERAL 1.0X100.0 7/1/2010
DP/5202 LIMITED CHEMICALS LTD - T SONE L/139 TO L/146, VERNA ORDINARY MG VIAL
HUMAN INJECTION SODIUM INDUSTRIAL ESTATE, DRY VIALS
SUCCINATE VERNA, SOUTH GOA
2602 NDA/MAL/H KAMPALA KAMPALA KAM METRONIDAZ 200MG KAMPALA UGANDA ORAL SOLID 10.0X10.0 7/1/1997
DP/5203 PHARMACEUT PHARMACEUTIC METRO OLE PHARMECEUTICALS ORDINARY TABLET
ICAL AL INDUSTRIES INDUSTRIES LTD.-PLOT TABLETS BLISTER,1.
INDUSTRIES 1996 LIMITED M444B STRETCHER RD, 0X100.0X1
1996 LIMITED NTINDA KLA UGANDA 0.0
TABLET
BLISTER,1.
0X250.0
TABLET
CONTAIN
ER,1.0X50
0.0
2603 NDA/MAL/H KAMPALA KAMPALA KAM-VENT SALBUTAMOL 4MG KAMPALA UGANDA ORAL SOLID 1.0X10.0 7/1/1997
DP/5205 PHARMACEUT PHARMACEUTIC PHARMACEUTICALS ORDINARY TABLET
ICAL AL INDUSTRIES INDUSTIES-PLOT NO M44B TABLETS BLISTER,1.
INDUSTRIES 1996 LIMITED STRETCHER ROAD 0X100.0
1996 LIMITED INTINDA TABLET
CARTON,1
.0X250.0
TABLET
JAR,1.0X5
00.0
TABLET
JAR,1.0X1
2604 NDA/MAL/H SHOSAAN RENE DIGOXIN DIGOXIN 0.25MG NEM LABORATORIES PVT. INDIA ORAL SOLID 1.0X10.0X 7/1/2013
DP/5207 ASIC PACIFIC PHARMACY LTD TABLETS LIMITED-133 KRISHNA ORDINARY 10.0
IND. ESTATE, VASAI (E), TABLETS TABLET
THANE – 401 210, BLISTER,1.
MAHARASHTRA - INDIA 0X1000.0
TABLET
CONTAIN
ER
2605 NDA/MAL/H SK AGE ABACUS DINAC GEL DICLOFENAC 1%W/W S KANT HEALTHCARE LTD- INDIA TOPICAL 1.0X20.0 7/1/2009
DP/5211 EXPORTS PHARMA 1802-1805 GIDC PHASE III EXTERNAL G TUBE
(AFRICA) VAPI 396 195 GUJARAT GELS AND
LIMITED SOLS
2606 NDA/MAL/H NIRMA LIFE PHARMA NIRMET METRONIDAZ 500MG/10 ACULIFE HEALTHCARE INDIA PARENTERAL 1.0X100.0 7/1/2010
DP/5214 LIMITED. AFRICA LIMITED OLE 0ML PVT. LTD-VILLAGE ORDINARY ML
SACHANA ,TALUKA - INFUSION BOTTLE
VIRAMGAM , VIALS/BOTTL
AHMEDABAD 382150 ES
GUJARAT
2607 NDA/MAL/H J.B TATA UGANDA METROGYL METRONIDAZ 200MG J.B. CHEMICALS AND INDIA ORAL SOLID 1.0X10.0X 7/1/2001
DP/5215 CHEMICALS & LIMITED TABLETS OLE PHARMACEUTICALS LTD .- ORDINARY 10.0
PHARMACEUT 128/1, GIDC, FILM- TABLET
ICALS LTD ANKLESHWAR 393 002, COATED BLISTER,1.
GUJARAT GLOBELA TABLETS 0X20.0X5.
PHARMA PVT.LTD.-PLOT 0X10.0
NO.357,G.I.D.C SACHIN TABLET
ROAD NO.3,SURAT- BLISTER,1.
394230,GUJARAT 0X1000.0
TABLET
CONTAIN
ER,1.0X5.
2608 NDA/MAL/H GITTOES GITTOES DICLOFENA DICLOFENAC 75MG/3ML NINGBO DAHONGYING CHINA PARENTERAL 1.0X10.0X 7/1/2006
DP/5221 PHARMACEUT PHARMACEUTIC C SODIUM SODIUM PHARMACEUTICAL CO.LTD- ORDINARY 10.0X3.0
ICALS LIMITED ALS LIMITED NO. 396 MINGZHU ROAD, AMPOULES ML
HI-TECH PARK, NINGBO AMPOULE
CHINA
2609 NDA/MAL/H MYLAN KIMSY MEDS EMTRICITA EMTRICITABI 200MG/30 MYLAN LABORATORIES INDIA ORAL SOLID 1.0X30.0 7/7/2008
DP/5222 LABORATORIE LTD BINE+TENO NE/TENOFOV 0MG LTD ,-PLOT NO. 11, 12, & ORDINARY TABLET
S LIMITED FOVIR DF IR 13 INDORE SPECIAL FILM- CONTAIN
ECONOMIC ZONE, COATED ER
PHARMA ZONE, PHASE II, TABLETS
SECTOR III PITHAMPUR
454775, DIST DHAR –
MADHYA PRADESH
MYLAN LABORATORIES
LIMITED.-PLOT NO. H-12 &
H-13
MIDC, WALUJ INDUSTRIAL
2610 NDA/MAL/H AUROBINDO GITTOES EMTRICITA EMTRICITABI 200MG/30 AUROBINDO PHARMA LTD INDIA ORAL SOLID 1.0X30.0 7/1/2009
DP/5224 PHARMA LTD PHARMACEUTIC BINE+TENO NE/TENOFOV 0MG UNIT III-AUROBINDO ORDINARY TABLET
ALS LIMITED FOVIR IR PHARMA LTD UNIT III FILM- CONTAIN
DISOPROXIL DISOPROXIL SURVEY NO. 313 COATED ER
FUMERATE FUMERATE BACHUPALLY VILLAGE TABLETS
QUTHUBULLAPUR
MANDAL RANGA REDDY
DISTRICT (A.P)
2611 NDA/MAL/H HETERO AIVEEN (U) EMTRICITA EMTRICITABI 200MG/30 HETERO DRUGS LTD-UNIT- INDIA ORAL SOLID 1.0X30.0 7/1/2013
DP/5226 DRUGS LTD LIMITED BINE+TENO NE+TENOFOV 0MG 111 NO 22-110 I.D.A ORDINARY TABLET
FOVIR IR JEEDIMETTA HYDRABAD TABLETS CONTAIN
DISOPROXIL DISOPROXIL 500055 HETERO LABS LTD ER
FUMERATE FUMERATE (UNIT-V)-
SY.NO.438,439,440 & 458
APIIC FORMULATION SEZ,
POLEPALLY (V),
JEDCHERLA (M)
MAHABOOBNAGAR
DISTRICT, ANDHRA
PRADESH - INDIA
2612 NDA/MAL/H CENTAUR GITTOES DICLOGENT DICLOFENAC 1MG/ML+3 CENTAUR INDIA OPHTHALMI 1.0X5.0 7/1/2009
DP/5228 PHARMACEUT PHARMACEUTIC A SODIUM+GEN MG/ML PHARMACEUTICALS PVT C DROPS ML
ICALS PVT LTD ALS LIMITED TAMICIN LTD --PLOT NO.3 TIVIN BOTTLE
SULPHATE INDUSTRIAL ESTATE
KARASWADA 403526
INDIA
2613 NDA/MAL/H INTAS, NORVIK ENAPRIL 10 ENALAPRIL 10MG INTAS PHARMACEUTICALS INDIA ORAL SOLID 1.0X10.0X 7/1/2005
DP/5231 PHARMACEUT ENTERPRISES MALEATE LTD-PLOT 457/458, ORDINARY 10.0
ICALS LTD LIMITED SARKHEJ BAVLA HIGHWAY TABLETS TABLET
MATODA 382 210 TAL: BLISTER
SANAND, AHMEDABAD,
INDIA
INTAS
PHARMACEUTICALS
LIMITED(BIOPHARMA
DIVISION)-CAMP ROAD
SELAQUI-248197,
DEHRADUN
2614 NDA/MAL/H INTAS, NORVIK ENAPRIL-5 ENALAPRIL 5MG INTAS PHARMACEUTICALS INDIA ORAL SOLID 1.0X10.0X 7/1/2006
DP/5232 PHARMACEUT ENTERPRISES MALEATE LIMITED(BIOPHARMA ORDINARY 10.0
DEHRADUN
(UTTARAKHAND) INDIA
2615 NDA/MAL/H CADILA KARURI ENVAS 10 ENALAPRIL 10MG CADILA INDIA ORAL SOLID 1.0X10.0X 7/1/1997
DP/5233 PHARMACEUT PHARMACEUTIC MG PHARMACEUTICALS ORDINARY 10.0
ICALS LIMITED ALS LTD. TABLETS LIMITED-1389, TRASAD TABLETS TABLET
STATE, INDIA
2616 NDA/MAL/H CADILA KARURI ENVAS ENALAPRIL 5MG CADILA INDIA ORAL SOLID 1.0X10.0X 7/1/1997
DP/5234 PHARMACEUT PHARMACEUTIC 5MG MALEATE PHARMACEUTICALS ORDINARY 10.0
ICALS LIMITED ALS LTD. TABLETS LIMITED-1389, TRASAD TABLETS TABLET
STATE, INDIA
2617 NDA/MAL/H UNIQUE TATA UGANDA DICLORAN DICLOFENAC 50MG UNIQUE INDIA ORAL SOLID 1.0X10.0X 7/1/1997
DP/5235 PHARMACEUT LIMITED DELAYED- SODIUM PHARMACEUTICAL RETARD 10.0
ICALS RELEASE LABORATORIES (A DIV. OF ENTERIC- TABLET
LABORATORIE TABLETS J.B CHEMICALS & COATED BLISTER,1.
S PHARMACEUTICALS LTD)-- TABLETS 0X1000.0
216-219 GIDC INDUSTRIAL TABLET
AREA PANOLI 394 116 CONTAIN
DIST BHARUCH ER,5.0X2.
0X10.0
TABLET
BLISTER
2618 NDA/MAL/H I-CARE AIVEEN (U) EUROCIP CIPROFLOXAC 200MG/10 EUROLIFE HEALTHCARE INDIA PARENTERAL 1.0X100.0 7/1/2010
DP/5237 PHARMA LTD LIMITED IN 0ML PVT LTD-BHAGWANPUR ORDINARY ML
ROAD, UTTARAKHAND INFUSION BOTTLE
VIALS/BOTTL
ES
2619 NDA/MAL/H IND SWIFT PLANET EZO 20 ESOMEPRAZO 20MG IND-SWIFT-LTD,-GLOBAL INDIA ORAL SOLID 1.0X10.0X 7/1/2013
DP/5243 LTD PHARMACEUTIC LE BUSINESS UNIT, RETARD 10.0
ALS UGANDA MAGNESIUM JAWAHARPUR, OFF NH-21 TABLETS TABLET
LTD DERABASSI BLISTER
2620 NDA/MAL/H INTAS NORVIK FABUTAS- FEBUXOSTAT 40MG INTAS PHARMACEUTICALS INDIA ORAL SOLID 1.0X3.0X1 7/1/2013
DP/5245 PHARMACEUT ENTERPRISES 40 LIMITED(BIOPHARMA ORDINARY 0.0
ICALS LTD LIMITED DIVISION)-CAMP ROAD FILM- TABLET
SELAQUI-248197, COATED BLISTER
DEHRADUN TABLETS
(UTTARAKHAND) INDIA
2621 NDA/MAL/H KAMPALA KAMPALA KAM-AMPI AMPICILLIN 250MG KAMPALA UGANDA ORAL SOLID 1.0X10.0 7/1/1997
DP/5248 PHARMACEUT PHARMACEUTIC PHARMACEUTICAL ORDINARY CAPSULE
ICAL AL INDUSTRIES INDUSTRIES (1996) CAPSULES CONTAIN
NTINDA KAMPALA CAPSULE
CONTAIN
ER,1.0X10
00.0
CAPSULE
CONTAIN
ER,1.0X50
2622 NDA/MAL/H EMCURE HARLEYS ENCIFER IRON 100MG/5 EMCURE INDIA PARENTERAL 1.0X5.0X5 7/1/2013
DP/5249 PHARMACEUT UGANDA SUCROSE ML PHARMACEUTICALS LTD - ORDINARY .0 ML
ICALS LTD LIMITED PLOT NO. P-1 ITBT PARK INFUSION AMPOULE
PHASE II MIDC HINJWADI AMPOULES
PUNE 411057
2623 NDA/MAL/H PHARCO WIDE FARCOLIN SALBUTAMOL 2MG/5ML PHARCO EGYPT ORAL LIQUID 1.0X120.0 7/1/1998
DP/5250 PHARMACEUT SPECTRUM SYRUP + +100MG/5 PHARMACEUTICALS LTD- ORDINARY ML
ICALS ENTERPRISES AMMONIUM ML KILO 31 ALEXANDRIA, SYRUPS BOTTLE
(U) LIMITED CHLORIDE CAIRO DESERT ROAD,
ALEXANDRIA EGYPT
2624 NDA/MAL/H PFIZER LABOREX DIFLUCAN FLUCONAZOL 150MG PFIZER PGM -AMBROISE FRANCE ORAL SOLID 1.0X1.0 7/1/1997
DP/5251 LABORATORIE UGANDA E ZONE INDUSTRIELLE 29 ORDINARY CAPSULE
S (PTY) LTD LIMITED ROUTE DES INDUSTRIES CAPSULES BLISTER
37530 POCE SUR CISSE
2625 NDA/MAL/H PHARCO WIDE FARCOZOL BENZOYL 200MG/5 PHARCO EGYPT ORAL LIQUID 1.0X120.0 7/1/1998
DP/5253 PHARMACEUT SPECTRUM SUSPENSIO METRONIDAZ ML PHARMACEUTICALS LTD- ORDINARY ML
ICALS ENTERPRISES N OLE KILO 31 ALEXANDRIA, SUSPENSION BOTTLE
(U) LIMITED CAIRO DESERT ROAD, S
ALEXANDRIA EGYPT
2626 NDA/MAL/H PFIZER LABOREX FARMORUB EPIRUBICIN 10MG PHARMACIA AND UPJOHN EUROPE PARENTERAL 1.0X50.0 7/1/1998
DP/5254 LABORATORIE UGANDA ICIN RD HYDROCHLOR S.P.A.-EUROPE ORDINARY ML
S LTD LIMITED IDE VIALS VIAL,1.0X
10.0 ML
VIAL
2627 NDA/MAL/H GLAXOSMITH UNITED ENO MULTI- MULTI- GLAXO SMITH KLINE LTD- SOUTH ORAL LIQUID 1.0X8.0X4 7/1/2000
DP/5255 KLINE LTD HEALTHCARE LEMONFRU INGREDIENT INGREDIEN LIKONI RD, INDUSTRIAL AFRICA ORDINARY .5 G
DISTRIBUTORS IT SALT T AREA,NAIROBI KENYA EFFERVESCE SACHET,1.
LTD GLAXOSMITHLINE-CAPE NT 0X10.0X4.
TOWN, S.A POWDERS/G 5G
RANULES SACHET,1.
0X48.0X4.
5G
SACHET,1.
0X4.0X4.5
G
SACHET,1.
2628 NDA/MAL/H MEDIPHARM MEDIPHARM ERYMED ERYTHROMYC 125MG/5 MEDIPHARM INDUSTRIES UGANDA ORAL LIQUID 1.0X100.0 7/1/2007
DP/5258 SALES INDUSTRIES ORAL IN ML (E.A) LTD-PLOT 65, ORDINARY ML
LIMITED (E.A) LTD SUSPENSIO KAKAJJO ROAD SUSPENSION BOTTLE
N (BWEYOGERERE) S
2629 NDA/MAL/H COSMOS LTD ASTRA PHARMA CARDINOL ATENOLOL 100MG COSMOS LTD.-RANGWE KENYA ORAL SOLID 2.0X14.0 7/1/1997
DP/5259 (U) LIMITED TABLET ROAD; OFF LUNGA LUNGA ORDINARY TABLET
ROAD. P.O BOX 414 33, FILM- STRIP
NAIROBI COATED
TABLETS
2630 NDA/MAL/H ABOTT HARLEYS ENTAMIZOL DILOXINIDE 250MG/20 ABBOT LABORATORIES PAKISTAN ORAL SOLID 1.0X3.0X1 7/1/2006
DP/5261 LABORATORIE UGANDA E FUROATE/ME 0MG (PAKISTAN) LTD-PLOT ORDINARY 0.0
S S.A (PTY) LIMITED TRONIDAZOL NO.13 SECTOR 20 FILM- TABLET
LIMITED E KORANG INDUSTRAL COATED BLISTER
AREA, KARACHI PAKISTAN TABLETS
2631 NDA/MAL/H MSD (PTY) PHILLIPS DIPROSALIC BETAMETHAS 0.5 %W/W SCHERING-PLOUGH LABO BELGIUM TOPICAL 1.0X30.0 7/1/2001
DP/5263 LIMITED SA PHARMACEUTIC OINTMENT ONE + + 0.3 N.V--INDUSTRIE PARK 30, EXTERNAL MG TUBE
ALS (UGANDA) SALICYLIC %W/W ZONE A 2220 HEIST-OP- OINTMENTS
LIMITED ACID DEN-BERG
2632 NDA/MAL/H MSD (PTY) PHILLIPS DIPROSONE BETAMETHAS 0.5%W/W SCHERING PLOUGH LABO BELGIUM TOPICAL 1.0X30.0 7/1/2001
DP/5265 LIMITED SA PHARMACEUTIC OINTMENT ONE N.V,-INDUSTRY PARK 30, EXTERNAL G
ALS (UGANDA) DIPROPIONAT 2220 HEIST OPDENBERG OINTMENTS CONTAIN
LIMITED E BELGIAM ER,1.0X10
.0 G
CONTAIN
ER
2633 NDA/MAL/H ABOTT HARLEYS ENTAMIZOL DILOXANIDE 250MG+20 ABBOTT LABORATORIES PAKISTAN ORAL LIQUID 1.0X100.0 7/1/2006
DP/5266 LABORATORIE UGANDA E FUROATE/ 0MG/10ML PAKSTAN LTD-PLOT 13, ORDINARY ML
S S.A (PTY) LIMITED SUSPENSIO METRONIDAZ SECTOR 20, KORANGI SUSPENSION BOTTLE
LIMITED N OLE INDUSTRIAL AREA, S
KARACHI PAKISTAN.
2634 NDA/MAL/H ABACUS ABACUS ERYTHROM ERYTHROMYC 250MG MEDICAMEN BIOTECH LTD- INDIA ORAL SOLID 1.0X10.0X 7/1/2014
DP/5267 PHARMA (A) PHARMA YCIN IN STEARATE SP-1192, A &B, PHASE –IV, ORDINARY 10.0
LTD. (AFRICA) STEARATE INDUSTRIAL AREA TABLETS TABLET
LIMITED BHIWADI -301019 DIST. BLISTER
ALWAR (RAJASTHAN)
2635 NDA/MAL/H MISSION JOINT MEDICAL ERYTHROM ERYTHROMYC 100MG MEDICAMEN BIOTECH LTD- INDIA ORAL SOLID 1.0X1000. 7/1/2010
DP/5268 PHARMA A/S STORE (UPMB - YCIN IN SP-1192, A &B, PHASE –IV, ORDINARY 0 TABLET
INDIA UCMB) STEARATE INDUSTRIAL AREA TABLETS CONTAIN
TABLETS BHIWADI -301019 DIST. ER
ALWAR (RAJASTHAN)
2636 NDA/MAL/H INTAS, NORVIK DIVAA OD DIVALPROEX 500MG INTAS PHARMACEUTICALS INDIA ORAL SOLID 1.0X3.0X1 7/1/2010
DP/5269 PHARMACEUT ENTERPRISES 500 LIMITED(BIOPHARMA ORDINARY 0.0
DEHRADUN
(UTTARAKHAND) INDIA
2637 NDA/MAL/H ABOTT HARLEYS ENTAMIZOL DILOXANIDE 500MG/40 ABBOT LABORATORIES PAKISTAN ORAL SOLID 1.0X1.0X1 7/1/2006
DP/5270 LABORATORIE UGANDA E DS FUROATE/ 0MG (PAKISTAN) LTD-PLOT ORDINARY 5.0
S S.A (PTY) LIMITED METRONIDAZ NO.13 SECTOR 20 FILM- TABLET
LIMITED OLE KORANG INDUSTRAL COATED BLISTER
AREA, KARACHI PAKISTAN TABLETS
2638 NDA/MAL/H REGAL REGAL PHARMA ERYTHYL ERYTHROMYC 125MG/5 REGAL KENYA ORAL LIQUID 1.0X100.0 7/1/1997
DP/5271 PHARMACEUT (U) LTD SYRUP IN ETHYL ML PHARMACEUTICALS LTD- ORDINARY ML
ICALS LTD SUCCINATE BABA DOGO ROAD, DRY BOTTLE
S/SYRUPS/D
ROPS
2639 NDA/MAL/H GITTOES GITTOES DIX DIGOXIN 0.25MG AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1.0X10.0X 7/1/2011
E INDIA TABLET
CONTAIN
ER
DP/5275 PHARMA LTD PHARMACEUTIC LIMITED (UNIT III) -AURO ORDINARY CAPSULE
ALS LIMITED HOUSE, 313, BUCHUPALLY, CAPSULES CONTAIN
QUTHUBULLAPAR(M), RR ER,1.0X30
DISTRICT HYDERABAD- .0
500090, ANDHERA CAPSULE
PRADESH, INDIA. CONTAIN
ER
2641 NDA/MAL/H EGYPTIAN WIDE DOSIN DOXAZOCIN 2MG EGYPTIAN EGYPT ORAL SOLID 1.0X2.0X1 7/1/2011
DP/5279 INTERNATION SPECTRUM INTERNATIONAL ORDINARY 0.0
AL ENTERPRISES PHARMACEUTICAL TABLETS TABLET
PHARMACEUT (U) LIMITED INDUSTRIES COMPANY- BLISTER
COMPANY
2642 NDA/MAL/H AUROBINDO GITTOES EFAVIRENZ EFAVIRENZ + 600MG AUROBINDO PHARMA LTD INDIA ORAL SOLID 1.0X30.0 7/1/2015
DP/5281 PHARMA LTD PHARMACEUTIC +EMTRICIT EMTRICITABI +200MG + UNIT VII-SEZ SURVEY NO. ORDINARY TABLET
ALS LIMITED ABINE+TEN NE + 300MG 411/P,425/P, 434/P, 435/P FILM- CONTAIN
OFOVIR TENOFOVIR AND 458/P PLOT NO S1 ( COATED ER
DISOPROXIL DISOPROXIL PART) SPECIAL ECONOMIC TABLETS
FUMARATE ZONE GREEN INDUSTRIAL
PARK POLEPALLY
VILLAGRE ANDHRA
PRADESH 509302
2643 NDA/MAL/H TRIVENI AIVEEN (U) DORFEN ACECLOFENA 100MG TRIVENI FORMULATIONS INDIA ORAL SOLID 1.0X10.0X 7/1/2014
DP/5282 FORMULATIO LIMITED C LIMITED --PLOT NO 52- ORDINARY 10.0
NS LIMITED 54,62-64 ALEAP FILM- TABLET
INDUSTRIAL ESTATE COATED BLISTER
SURAMPALLI (V) TABLETS
VIJAYAWADA A.P
2644 NDA/MAL/H REGAL REGAL PHARMA IBUMEX IBUPROFEN 5%W/W REGAL KENYA TOPICAL 1.0X25.0 7/1/2001
DP/5283 PHARMACEUI (U) LTD GEL PHARMACEUTICALS LTD- EXTERNAL G TUBE
CALS LTD BABA DOGO ROAD, EMULSION
RAURAKA,NAIROBI,KENYA GELS
2645 NDA/MAL/H AUROBINDO GITTOES EFAVIRENZ EFAVIRENZ + 600MG + AUROBINDO PHARMA INDIA ORAL SOLID 1.0X30.0 7/1/2015
DP/5287 PHARMA LTD PHARMACEUTIC + LAMIVUDINE 300MG + LIMITED (SEZ, UNIT – VII), - ORDINARY TABLET
ALS LIMITED LAMIVUDIN + TENOFOVIR 300MG SURVEY NO.411, 425, 434, TABLETS CONTAIN
E+ DISOPROXIL 435 & 458, APIIC, PLOT ER
TENOFOVIR FUMERATE NO. SI GREEN INDUSTRIAL
DISOPROXIL PARK, POLEPALLY
FUMERATE VILLAGE, JEDCHERLA
MANDAL, MAHABOOB
NAGAR DISTRICT,
HYDERABAD, ANDHRA
PRADESH 500090, INDIA
2646 NDA/MAL/H REGAL REGAL PHARMA IBUMEX IBUPROFEN 100MG/5 REGAL KENYA ORAL LIQUID 100.0 ML 7/1/1997
DP/5288 PHARMACEUI (U) LTD SUSPENSIO ML PHARMACEUTICALS LTD- ORDINARY BOTTLE,6
CALS LTD N BABA DOGO ROAD, SUSPENSION 0.0 ML
RAURAKA,NAIROBI,KENYA S BOTTLE,1.
0X60.0 ML
BOTTLE,1.
0X100.0
ML
BOTTLE
2647 NDA/MAL/H MSD (PTY) PHILLIPS ELOCOM MOMETASON 0.1%W/W SCHERING-PLOUGH LABO BELGIUM TOPICAL 1.0X15.0 7/1/2000
DP/5290 LIMITED SA PHARMACEUTIC CREAM E FUROATE N.V--INDUSTRIE PARK 30,B- EXTERNAL G TUBE
ALS (UGANDA) 2220 HEIST-OP-DEN- CREAMS
LIMITED BERG,BELGIUM
2648 NDA/MAL/H REGAL REGAL PHARMA IBUMEX IBUPROFEN 200MG REGAL KENYA ORAL SOLID 10.0X10.0 7/1/1997
DP/5291 PHARMACEUI (U) LTD TABLET PHARMACEUTICALS LTD- ORDINARY TABLET
CALS LTD BABA DOGO ROAD, FILM- BLISTER,1.
RAURAKA,NAIROBI,KENYA COATED 0X20.0
TABLETS TABLET
BLISTER,1.
0X500.0
TABLET
CONTAIN
ER
2649 NDA/MAL/H LINCOLN METRO DOMI 10 DOMPERIDO 10MG LINCOLN INDIA ORAL SOLID 1.0X10.0X 7/1/2011
DP/5292 PHARMACEUT PHARMACEUTIC NE PHARMACEUTICAL ORDINARY 10.0
INDIA
2650 NDA/MAL/H MSD (PTY) PHILLIPS ELOCOM MOMETASON 0.1%W/W SCHERING-PLOUGH LABO BELGIUM TOPICAL 1.0X15.0 7/1/2000
DP/5294 LIMITED SA PHARMACEUTIC OINTMENT E FUROATE N.V--INDUSTRIE PARK 30,B- EXTERNAL G TUBE
ALS (UGANDA) 2220 HEIST-OP-DEN- OINTMENTS
LIMITED BERG,BELGIUM
2651 NDA/MAL/H LABORATORY HARLEYS DOXY DOXYCYCLINE 100MG LABORATORY & ALLIED KENYA ORAL SOLID 1.0X1000. 7/1/2000
DP/5295 &ALLIED LTD UGANDA LTD--PLOT NO. 209/ ORDINARY 0
LIMITED 10349, OPP. SAMEER CAPSULES CAPSULE
BUSINESS PARK, CONTAIN
MOMBASA ROAD P.O. ER,1.0X28
BOX 42875, GPO 00100, 0.0
NAIROBI, KENYA CAPSULE
CONTAIN
ER,1.0X10
.0X10.0
CAPSULE
BLISTER
2652 NDA/MAL/H VHB MEDI LLOYDS DOMAXIN- DOXORUBICI 50MG VHB MEDI SCIENCES LTD- INDIA PARENTERAL 1.0X1.0X5 7/1/2010
DP/5296 SCIENCES LTD PHARMACY RD N PLOT 20, 21, 22 & 49,50, ORDINARY 0.0 MG
LIMITED 51. INTEGRATED VIALS VIAL
5, RUDRAPUR,
UTTARAKHAND - INDIA
2653 NDA/MAL/H CADILA KARURI DOLAC KETOROLAC 30MG CADILA INDIA PARENTERAL 1.0X10.0X 7/1/2015
DP/5300 PHARMACEUT PHARMACEUTIC TROMETHAM PHARMACEUTICALS ORDINARY 1.0 ML
ICALS ALS LTD. INE LIMITED-1389, TRASAD AMPOULES AMPOULE
STATE, INDIA
2654 NDA/MAL/H SANOFI LABOREX DULTAVAX DIPHTERIA/ 2 IU/ 20IU/ SANOFI PASTEUR CAMPUS FRANCE PARENTERAL 1.0X0.5 7/1/2011
DP/5301 PASTEUR UGANDA TETANUS/ POLIOMYE MERIEUX--1541 AVENUE ORDINARY I ML PRE-
LIMITED AND LITIS MARCEL MERIEUX, 69280 V PRE-FILLED FILLED
(INACTIVATE (40DU/ MARCY, LETOILE SYRINGES SYRINGE
D) 8DU/
POLIOMYELIT 32DU)
IS VACCINE
(ADSORBED)
2655 NDA/MAL/H GITTOES GITTOES IBUGO- IBUPROFEN + 200MG + AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1.0X2.0X1 7/1/2014
DP/5302 PHARMACEUT PHARMACEUTIC COMBI PARACETAM 325MG + NO.33,SECTOR ORDINARY 0.0
ICALS LIMITED ALS LIMITED OL + 30MG II,VASAI,TALUKA INDL CO- CAPSULES CAPSULE
CAFFEINE OP ESTATE LTD,GAURAI BLISTER,1.
E INDIA .0
CAPSULE
BLISTER,1.
0X100.0X1
0.0
CAPSULE
BLISTER
2656 NDA/MAL/H GITTOES GITTOES IBUGO - IBUPROFEN 200MG AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1.0X100.0 7/1/2008
DP/5305 PHARMACEUT PHARMACEUTIC 200 NO.33,SECTOR ORDINARY X10.0
ICALS LIMITED ALS LIMITED II,VASAI,TALUKA INDL CO- OTHER TABLET
E INDIA TABLET
CONTAIN
ER,1.0X10
.0X10.0
TABLET
BLISTER
2657 NDA/MAL/H USV PRIVATE ABACUS DUOTROL GLYBURIDE + 5MG + FREDUN INDIA ORAL SOLID 1.0X10.0X 7/1/2005
DP/5307 LIMITED PHARMA METFORMIN 500MG PHARMACEUTICALS ORDINARY 10.0
(AFRICA) HYDROCHLOR LIMITED---14,15,16 TABLETS TABLET
LIMITED IDE ZORABIAN INDUSTRIAL BLISTER
COMPLEX PALAGHAR
404 INDIA
2658 NDA/MAL/H MISSION JOINT MEDICAL DOXYCYCLI DOXYCYCLINE 100MG MEDICAMEN BIOTECH LTD- INDIA ORAL SOLID 1.0X1000. 7/1/2010
DP/5309 PHARMA A/S STORE (UPMB - NE SP-1192, A &B, PHASE –IV, ORDINARY 0
INDIA UCMB) CAPSULES INDUSTRIAL AREA CAPSULES CAPSULE
BP BHIWADI -301019 DIST. CONTAIN
ALWAR (RAJASTHAN) ER
2659 NDA/MAL/H ABBOTT HARLEYS DUPHASTO DYDROGESTE 10MG ABBOTT BIOLOGICALS B.V - NETHERLAND ORAL SOLID 1.0X20.0 7/1/2001
DP/5311 HEALTHCARE UGANDA N TABLETS RONE ABBOTT BIOLOGICALS B.V S ORDINARY TABLET
PRODUCTS LIMITED VEERWEG 12 8121 AA FILM- BLISTER
B.V. OLST COATED
TABLETS
2660 NDA/MAL/H TROIKAA ABACUS DYNAPAR DICLOFENAC 50MG + TROIKAA INDIA ORAL SOLID 1.0X10.0X 7/1/2009
DP/5316 PHARMACEUT PHARMA SODIUM + 500MG PHARMACEUTICALS LTD .- ORDINARY 10.0
ICALS LIMITED (AFRICA) PARACETAM SARA INDUSTRIAL ESTATE TABLETS TABLET
LIMITED OL SELAQUI DEHRADUN BLISTER
248197 UTTARAKHAND,
INDIA
2661 NDA/MAL/H MACK SHURIK LTD DR MAC'S TERBUTALINE 2.5MG+8.0 TORQUE INDIA ORAL LIQUID 1.0X100.0 7/1/2003
DP/5317 BROWN COUGH SULPHATE+B MG+100M PHARMACEUTICALS LTD- ORDINARY ML
FORMULA ROMHEXINE G+5MG ISSAPUR P.O DAPPAR SYRUPS BOTTLE
HYDROCHLOR 140506
IDE+GUAIFEN
ESIN+MENTH
OL
2662 NDA/MAL/H TROIKAA ABACUS DYNAPAR DICLOFENAC 75MG/ML TROIKAA INDIA PARENTERAL 1.0X5.0X1 7/1/2009
DP/5318 PHARMACEUT PHARMA AQ (1ML) SODIUM PHARMACEUTICALS LTD .- ORDINARY .0 ML
ICALS LIMITED (AFRICA) SARA INDUSTRIAL ESTATE AMPOULES AMPOULE
248197 UTTARAKHAND,
INDIA
2663 NDA/MAL/H LEBEN ANDYCO INDOL INDOMETHAC 25MG LEBEN LAB PVT LTD-L4 INDIA ORAL SOLID 1.0X1000. 7/1/2010
DP/5320 LABORATORIE PHARMACY IN PHASE 111 MIDCS AKOLA ORDINARY 0
S PVT.LTD (UGANDA) LTD 444104 MAHARASTRA OTHER CAPSULE
INDIA CAPSULES CONTAIN
ER,1.0X10
.0X10.0
CAPSULE
BLISTER,1.
0X100.0X1
0.0
CAPSULE
BLISTER
2664 NDA/MAL/H DAR AL DAWA GAMA IBUGESIC IBUPROFEN/P 200MG/30 DAR AL DAWA-NA'UR JORDAN ORAL SOLID 1.0X2.0X1 7/1/2012
DP/5321 DEVELOPMEN PHARMACEUTIC COLD & SEUDOEPHED MG PLANT AMMAN ORDINARY 0.0
T AND ALS (U) LIMITED SINUS RINE GELATIN- TABLET
CO LTD TABLETS
2665 NDA/MAL/H STEDMAN VEERAM DREZ IODINATED 1.0% W/V STEDMAN INDIA TOPICAL 1.0X60.0 7/1/2010
DP/5323 PHARMACEUT HEALTHCARE POVIDONE + + 5.0% PHARMACEUTICALS PVT EXTERNAL ML
ICALS LTD (U) LIMITED METRONIDAZ W/V LTD...-C-4, SIDCO LIQUIDS CONTAIN
OLE PHARMACEUTICAL ER,1.0X30
COMPLEX ALATHUR, .0 ML
THIRUPORUR CONTAIN
ER,1.0X10
0.0 ML
CONTAIN
ER,1.0X50
0.0 ML
CONTAIN
2666 NDA/MAL/H UNIQUE TATA UGANDA ECODAX G ECONAZOLE 1%+0.1%+ UNIQUE INDIA TOPICAL 1.0X10.0 7/1/1997
DP/5326 PHARMACEUT LIMITED CREAM NITRATE + 0.025% PHARMACEUTICAL EXTERNAL G
ICAL GENTAMYCIN LABORATORIES-PLOT NO. CREAMS TUBE,1.0X
LABORATORIE + 215-219, G.I.D.C. 100.0 G
S BECLAMETAS INDUSTRIAL AREA,PANOLI TUBE
ONE — 394 116, GUJARAT,
INDIA.
2667 NDA/MAL/H STEDMAN VEERAM DREZ-V MICONAZOLE 2.0%W/W STEDMAN INDIA TOPICAL 1.0X30.0 7/1/2011
DP/5330 PHARMACEUT HEALTHCARE + + PHARMACEUTICALS PVT EXTERNAL G TUBE
ICALS PVT. (U) LIMITED METRONIDAZ 1.0%W/W LIMITED-NO. C-4, SIDCO GELS AND
LTD OLE PHARMACEUTICAL SOLS
COMPLEX, ALATHUR,
THIRUPORUR,
2668 NDA/MAL/H KAMPALA KAMPALA IBUFEN IBUPROFEN 200MG KPI ( KAMPALA UGANDA ORAL SOLID 1.0X100.0 7/1/1997
DP/5333 PHARMACEUT PHARMACEUTIC PHARMACEUTICAL ORDINARY X10.0
ICAL AL INDUSTRIES INDUSTIRES LTD-PLOT FILM- TABLET
INDUSTRIES 1996 LIMITED M444 B STRETCHER ROAD COATED BLISTER,5
(1996) LTD NTINDA TABLETS 00.0
TABLET
CONTAIN
ER,1000.0
TABLET
CONTAIN
ER,250.0
TABLET
2669 NDA/MAL/H COSMOS LTD ASTRA PHARMA ETHAM-400 ETHAMBUTO 400MG COSMOS LTD.-RANGWE KENYA ORAL SOLID 1.0X10.0X 7/1/1997
DP/5334 (U) LIMITED L ROAD; OFF LUNGA LUNGA ORDINARY 10.0
NAIROBI BLISTER,1.
0X1000.0
TABLET
CONTAIN
ER
2670 NDA/MAL/H SANOFI LABOREX AVAXIM INACTIVATED 160 SANOFI PASTEUR-1541 FRANCE PARENTERAL 1.0X0.5 7/1/2011
DP/5336 PASTEUR UGANDA 160U HEPATITIS A ANTIGEN AVENUE MARCEL ORDINARY I ML PRE-
LIMITED VACCINE UNITS MERIEUX, 69280 MARCY, M PRE- FILLED
ADSORBED LETOILE FILLED SYRINGE
SYRINGES
2671 NDA/MAL/H SANOFI LABOREX AVAXIM INACTIVATED 80 SANOFI PASTEUR-1541 FRANCE PARENTERAL 1.0X0.5 7/1/2011
DP/5337 PASTEUR UGANDA 80IU HEPATITIS A ANTIGEN AVENUE MARCEL ORDINARY I ML PRE-
LIMITED PAEDIATRIC VACCINE UNITS MERIEUX, 69280 MARCY, M PRE- FILLED
ADSORBED LETOILE FILLED SYRINGE
SYRINGES
2672 NDA/MAL/H LABORATORY HARLEYS HYDOPA METHYLDOPA 250MG LABORATORY & ALLIED KENYA ORAL SOLID 1.0X10.0X 7/1/1997
DP/5341 &ALLIED LTD UGANDA LTD-PLOT NO. 209/10349 ORDINARY 10.0
LIMITED OFF MOMBASA ROAD, TABLETS TABLET
NAIROBI BLISTER,1.
P.O. BOX 42875, NAIROBI, 0X1000.0
KENYA. TABLET
CONTAIN
ER
2673 NDA/MAL/H PHARCO WIDE CEFORAN CEFOTAXIME 1GM PHARCO B EGYPT PARENTERAL 1.0X1.0 G 7/1/2000
DP/5343 PHARMACEUT SPECTRUM 1GM SODIUM INTERNATIONAL:-- KILO ORDINARY VIAL +
ICALS LTD ENTERPRISES 31 ALEXANDRIA CAIRO DRY VIALS 1X5ML
(U) LIMITED DESERT ROAD ARAB AMPOULE
REPUBLIC OF EGYPT, P.O. OF WFI
BOX 12 SIDI GABER
ALEXANDRIA EGYPT
2674 NDA/MAL/H VHB MEDI LLOYDS CEFTRIMAX CEFTRIAXONE 1G + 0.5G VHB MEDI SCIENCES LTD- INDIA PARENTERAL 1.0X20.0 7/1/2014
DP/5345 SCIENCES LTD PHARMACY SODIUM + PLOT 20, 21, 22 & 49,50, ORDINARY ML VIAL
LIMITED SULBACTAM 51. INTEGRATED VIALS
5, RUDRAPUR,
UTTARAKHAND - INDIA
2675 NDA/MAL/H PHARMA OMAB UGANDA CEFUTIL CEFUROXIME 500MG PHARMA INTERNATIONAL JORDAN ORAL SOLID 1.0X10.0 7/1/2014
DP/5346 INTERNATION LIMITED 500 AXETIL COMPANY-MAIN STREET, ORDINARY TABLET
AL CO AL QASTAL INDUSTRIAL FILM- CONTAIN
AREA AMMAN- JORDAN COATED ER
JORDAN TABLETS
2676 NDA/MAL/H PHARMA OMAB UGANDA CEFUTIL CEFUROXIME 250MG PHARMA INTERNATIONAL JORDAN ORAL SOLID 1.0X10.0 7/1/2014
DP/5347 INTERNATION LIMITED 250 AXETIL COMPANY-MAIN STREET, ORDINARY TABLET
AL COMPANY AL QASTAL INDUSTRIAL FILM- BLISTER
JORDAN TABLETS
2677 NDA/MAL/H OTSUKA REDDYS CELEPID 20 INTRAVENOU 20%W/V OTSUKA INDIA PARENTERAL 1.0X250.0 7/1/2005
DP/5348 PHARMACEUT PHARMA S FAT PHARMACEUTICAL INDIA ORDINARY ML
ICAL INDIA LIMITED EMULSION PRIVATE LTD-VILLAGE – INFUSION BOTTLE,1.
PRIVATE VASANA – VIALS/BOTTL 0X500.0
LIMITED CHACHARWADIP, TAL: ES ML
SANAND, AHMADABAD BOTTLE
2678 NDA/MAL/H DAR AL DAWA GAMA CEPHADAR CEPHALEXIN 250MG/5 DAR AI DAWA-NA UR JORDAN ORAL LIQUID 1.0X100.0 7/1/2010
DP/5350 DEVELOPMEN PHARMACEUTIC FORTE ML PLANT,AMMAN,JORDAN ORDINARY ML
T AND ALS (U) LIMITED SUSPENSION BOTTLE
INVESTMENT S
CO LTD
2679 NDA/MAL/H DAR AL DAWA GAMA CEPHADAR CEPHALEXIN 125MG/5 DAR AI DAWA-NA UR JORDAN ORAL LIQUID 1.0X100.0 7/1/2009
DP/5351 DEVELOPMEN PHARMACEUTIC MONOHYDRA ML PLANT,AMMAN,JORDAN ORDINARY ML
T AND ALS (U) LIMITED TE SUSPENSION BOTTLE
INVESTMENT S
CO LTD
2680 NDA/MAL/H GLENMARK STAR MUMFER IRON(111) 50MG/5ML GLENMARK INDIA ORAL LIQUID 1.0X150.0 7/1/2005
DP/5352 PHARMACUTI PHARMACEUTIC POLYMALTOS PHARMACEUTICALS LTD ORDINARY ML
CALS LTD ALS LTD E COMPLEX PLOT E-PLOT NO. E-37, 39, SYRUPS BOTTLE
MIDC AREA, SATPUR,
NASIK - 422 007,
MAHARASHTRA
2681 NDA/MAL/H SHOSAAN RENE BURNNEM MULTI- N/A NEM LABORATORIES PVT INDIA TOPICAL 1.0X20.0 7/1/1997
DP/5356 ASIC PACIFIC PHARMACY LTD INGREDIENT LTD-133 VASAI RD(E) 401 EXTERNAL G TUBE
PAREL MUMBAI
2682 NDA/MAL/H CADILA ABACUS CADISTIN GUAIFENESIN 80MG+100 SAKAR HEALTHCARE PVT INDIA ORAL LIQUID 1.0X100.0 7/1/1997
DP/5358 HEALTHCARE PHARMA EXPECTORA +AMMONIU MG+2MG+ LTD-SAKAR HEALTHCARE ORDINARY ML
LTD (AFRICA) NT M 44MG PVT LTD, BLOCK NO 10-13, SYRUPS BOTTLE,1.
LIMITED CHLORIDE+C M.N. DESA 0X60.0 ML
HLORPHENIR BOTTLE
AMINE+SODI
UM CITRATE
2683 NDA/MAL/H MACK SHURIK LTD CALFIC MULTI- N/A TORQUE INDIA ORAL LIQUID 1.0X100.0 7/1/1997
DP/5361 BROWN INGREDIENT PHARMACEUTICALS LTD - ORDINARY ML
PHARMECEUT ISSAPUR P.O DAPPAR SYRUPS BOTTLE
2684 NDA/MAL/H ASTRA MACNAUGHTON CASODEX BICALUTAMID 150MG ASTRAZENECA UNITED ORAL SOLID 2.0X14.0 7/1/2001
DP/5362 ZENECA LIMITED 150MG E MACCLESFIELD-CHESHIRE KINGDOM ORDINARY TABLET
TABLETS STRIP
2685 NDA/MAL/H ASTRA MACNAUGHTON CASODEX BICALUTAMID 50MG ASTRA ZENECA UK UNITED ORAL SOLID 1.0X2.0X1 7/1/1997
DP/5363 ZENECA LIMITED 50MG E LIMITED-ASTRAZENECA UK KINGDOM ORDINARY 4.0
LIMITED SILK ROAD FILM- TABLET
BUSINESS PARK, MACCLES COATED BLISTER
FIELD,CHESHIRE SK 10 TABLETS
2NA, BULK CORDEN
PHARMA GMBH-OTT
HAHN STRASSE ,68723
GERMANY
2686 NDA/MAL/H NOVARTIS SURGIPHARM CATAFLAM DICLOFENAC 25MG NOVARTIS PHARMA SPA,- ITALY ORAL SOLID 1.0X100.0 7/1/1997
DP/5364 PHARMA AG (U) LIMITED 25MG POTASSIUM TORRE ANNUNZIATA ORDINARY TABLET
TABLETS ITALY NOVARTIS-- COATED CONTAIN
URUNLERI INSTABUL TABLETS ER,1.0X20
TURKEY .0 TABLET
CONTAIN
ER
2687 NDA/MAL/H NORVATIS SURGIPHARM CATAFLAM DICLOFENAC 15MG/ML NOVARTIS PHARMA SPA- FRANCE ORAL LIQUID 1.0X15.0 7/1/1997
DP/5365 PHARMA AG (U) LIMITED ORAL POTASSIUM RUE DE LA CHAPELLE, ORDINARY ML
DROPS HUNIGUE DROPS BOTTLE
2688 NDA/MAL/H HILTON HEALTHCARE CEFIM CEFIXIME 400MG HILTON PHARMA (PVT) PAKISTAN ORAL SOLID 1.0X5.0 7/1/2005
(PVT) LTD KORANGI INDUSTRIAL CAPSULES STRIP
AREA KARACHI
2689 NDA/MAL/H HILTON HEALTHCARE CEFIM CEFIXIME 100MG/5 HILTON PHARMA (PVT) PAKISTAN ORAL LIQUID 1.0X60.0 7/1/2005
DP/5367 PHARMA LTD. ML LTD-PLOT 13 SECTOR 15 ORDINARY ML
(PVT) LTD KORANGI INDUSTRIAL SUSPENSION BOTTLE,1.
AREA KARACHI S 0X30.0 ML
BOTTLE
2690 NDA/MAL/H PHARMA OMAB UGANDA CEFIX CEFIXIME 100MG/5 PHARMA INTERNATIONAL JORDAN ORAL LIQUID 1.0X60.0 7/1/2007
DP/5368 INTERNATION LIMITED 100MG/5M ML CO.-AMMAN JORDAN ORDINARY ML
AL COMPANY L DRY PLANT DRY BOTTLE,1.
SUSPENSIO AL-QARTAL MARKETING SUSPENSION 0X30.0 ML
N DEPARTMENT S/SYRUPS/D BOTTLE
ALBUJAH COMPLEX, ROPS
ALJUBAIHA
2691 NDA/MAL/H COSMOS LTD ASTRA PHARMA HYOSCINE HYOSCINE N- 10 MG COSMOS LIMITED - KENYA ORAL SOLID 1.0X10.0 7/1/2005
DP/5370 (U) LIMITED BUTYLBRO BUTYLBROMI RANGWA ROAD, OFF ORDINARY TABLET
MIDE DE LUNGA LUNGA ROAD, OTHER BLISTER,1.
INDUSTRIAL AREA COATED 0X1000.0
TABLETS TABLET
BLISTER
2692 NDA/MAL/H CIPLA QUALITY LAMIVUDIN LAMIVUDINE 10MG/ML CIPLA LTD.- -PLOT NO INDIA ORAL LIQUID 1.0X100.0 7/1/2007
DP/5371 LIMITED. CHEMICALS LTD - E L/139 TO L/146, VERNA ORDINARY ML
HUMAN INDUSTRIAL ESTATE, LIQUIDS BOTTLE
VERNA, SOUTH GOA
2693 NDA/MAL/H MICRO LABS PHARMA VILLE LAMIVUDIN LAMIVUDINE 150MG MICRO LABS LTD GOA- INDIA ORAL SOLID 1.0X60.0 7/1/2013
DP/5373 LTD GOA LIMITED E MICRO LABS LTD PLOT NO. ORDINARY TABLET
S-155 TO S-159 VERNA TABLETS CONTAIN
INDUSTRIAL ESTATE III ER
VERNA GOA 403722
2694 NDA/MAL/H CIPLA QUALITY LAMIVIR

LAMIVUDINE 50MG/5ML CIPLA LTD .-PLOT NO. 9, INDIA ORAL LIQUID 1.0X100.0 7/1/2004
DP/5374 LIMITED. CHEMICALS LTD - ORAL 10 AND 15, INDORE ORDINARY ML
HUMAN SOLUTION SPECIAL ECONOMIC ZONE, LIQUIDS BOTTLE,1.
PHASE –II, PITHAMPUR, 0X240.0
DISTRICT DHAR, PIN ML
CODE: 454775, MADHYA BOTTLE
PRADESH CIPLA LTD.- -
PLOT NO L/139 TO L/146,
VERNA INDUSTRIAL
ESTATE, VERNA, SOUTH
GOA DISTRICT, 403722
GOA
2695 NDA/MAL/H AUROBINDO GITTOES LAMIVUDIN LAMIVUDINE 150MG+30 AUROBINDOPHARMA INDIA ORAL SOLID 1.0X60.0 7/1/2005
DP/5376 PHARMA LTD PHARMACEUTIC E & + 0MG LIMITED,-SURVEY NO. 313 ORDINARY TABLET
ALS LIMITED ZIDOVUDIN ZIDOVUDINE & 314, BACHUPALLY TABLETS CONTAIN
E VILLAGE, ER
QUTHUBULLAPUR
MANDAL, HYDERABAD,
RANGA REDDY (DT),
ANDHRA PRADESH -
500090
INDIA.
2696 NDA/MAL/H JOHNSON&JO PHILLIPS BENYLIN DIPHENHYDR 25MG/20 JOHNSON&JOHNSON PTY SOUTH ORAL LIQUID 1.0X200.0 7/1/2001
DP/5377 HNSON PTY PHARMACEUTIC FOUR FLU AMINE + ML + LTD.-EDMS BPK241 MAIN AFRICA ORDINARY ML
LTD ALS (UGANDA) LIQUID PARACETAM 1G/20ML + ROAD /HOOFWEG SYRUPS BOTTLE
LIMITED OL + 45MG/20 241,RETREAT 7945,SOUTH
PSEUDOEPHE ML AFRICA
DRINE
2697 NDA/MAL/H AJANTA ABACUS ZOLANAS- LANSOPRAZO 30MG AJANTA PHARMA LIMITED- INDIA ORAL SOLID 1.0X3.0X1 7/1/2008
DP/5379 PHARMA LTD PHARMA 30 LE AJANTA PHARMA LIMITED ORDINARY 0.0
(AFRICA) B-4-5-6, MIDC AREA CAPSULES CAPSULE
LIMITED PAITHAN, AURANGABAD, BLISTER,1.
431148 0X10.0X10
DIST:AURANGABAD .0
MAHARASHTRA, INDIA. CAPSULE
BLISTER
2698 NDA/MAL/H CIRON DRUGS RENE CIROZEP DIAZEPAM 5MG/ML CIRON DRUGS & INDIA PARENTERAL 1.0X10.0X 7/1/2013
DP/5380 & PHARMACY LTD PHARMACEUTICALS PVT ORDINARY 10.0X2.0
PHARMACEUT LTD .-N-118,M.I.D.C, AMPOULES ML
ICALS PVT LTD TARAPUR,BOISAR, AMPOULE
DIST.THANE-401506,
MAHARASHTRA,INDIA.
2699 NDA/MAL/H LEBEN ANDYCO ADIFLAM DICLOFENAC 1.16%W/W LEBEN LABORATORIES INDIA TOPICAL 1.0X30.0 7/1/2008
DP/5381 LABORATORIE PHARMACY GEL DIETHYLAMIN PVT. LTD-PLOT NO. L-4, EXTERNAL G TUBE
S PVT LTD (UGANDA) LTD E PHASE-III, MIDC, GELS AND
AKOLA– 444 104 (MS). SOLS
2700 NDA/MAL/H WIN- SURGIPHARM UDIHEP URSODEOXYC 150MG WIN- MEDICARE LTD- INDIA ORAL SOLID 1.0X3.0X1 7/1/2001
DP/5386 MEDICARE (U) LIMITED TABLETS HOLIC ACID MODIPURAM -250 ORDINARY 0.0
LTD 110,UTTAR PRAADESH, TABLETS TABLET
INDIA. BLISTER
2701 NDA/MAL/H IPCA MEDVIN LARINATE- ARTESUNATE 60MG IPCA LABORATORIES LTD,- INDIA PARENTERAL 1.0X60.0 7/1/2011
DP/5388 LABORATOIES PHARMA 60 SEJAVTA,RATLAM 457-002 ORDINARY MG VIAL +
LTD LIMITED REG.OFF.48 KANDIVLI DRY VIALS 1*5 ML
IND.ESTATE MUMBAI SODIUM
400067 CHLORIDE
INJECTIO
N + 1*1
ML
AMPOULE
OF
SODIUM
BICARBO
2702 NDA/MAL/H CIPLA LTD QUALITY LUMARTEM ARTEMETHER 20MG + CIPLA LTD INDORE-PLOT 9 INDIA ORAL SOLID 1.0X1.0X2 7/1/2011
DP/5389 CHEMICALS LTD - + 120 MG & 10 INDORE SEZ ORDINARY 4.0
HUMAN LUMEFANTRI PITHAMPUR M.P 454 775 TABLETS TABLET
NE CIPLA LTD., PATALGANGA BLISTER,1.
UNIT I & UNIT II-PLOT NO. 0X1.0X6.0
A-33(UNIT-I), A-42( UNIT- TABLET
II), MIDC PATALGANGA, BLISTER,1.
410220 DISTRICT RAIGAD, 0X30.0X6.
MAHARASHTRA, INDIA 0 TABLET
BLISTER,1.
0X1.0X12.
0 TABLET
2703 NDA/MAL/H RENE RENE NITROFURA NITROFURAN 100MG RENE INDUSTRIES LTD- UGANDA ORAL SOLID 1.0X1000. 7/1/2008
DP/5391 INDUSTRIES INDUSTRIES NTOIN TOIN PLOT 680, KAMULI ROAD, ORDINARY 0 TABLET
KAMPALA ER
2704 NDA/MAL/H DENK BENLE CONSULT AMLO- AMLODIPINE 10MG DENK PHARMA GMBH GERMANY ORAL SOLID 1.0X5.0X1 7/1/2008
DP/5392 PHARMA LIMITED DENK 10 MESILATE &CO.KG- ORDINARY 0.0
GMB H &CO. MONOHYDRA PRINZREGENTESTR.79.816 TABLETS TABLET
KG TE 75 MUENCHEN, BLISTER
845529 TITTMONING
GERMANY
2705 NDA/MAL/H DENK BENLE CONSULT AMLO- AMLODIPINE 5MG DENK PHARMA GMBH GERMANY ORAL SOLID 1.0X5.0X1 7/1/2008
DP/5393 PHARMA LIMITED DENK 5 MESILATE &CO.KG- ORDINARY 0.0
GMB H &CO. MONOHYDRA PRINZREGENTESTR.79.816 TABLETS TABLET
KG TE 75 MUENCHEN, BLISTER
845529 TITTMONING
GERMANY
2706 NDA/MAL/H MICRO LABS LABOREX OFLOX OFLOXACIN 200MG MICRO LABS LTD-92, INDIA ORAL SOLID 1.0X10.0X 7/1/2005
DP/5395 LTD UGANDA SIPCOT INDUSTRIAL ORDINARY 10.0
TABLETS
2707 NDA/MAL/H GLENMARK STAR IBICAR-100 BECLOMETHA 100MCG GLENMARK INDIA LUNG 1.0X200.0 7/1/2013
DP/5397 PHARMACEUT PHARMACEUTIC SONE PER PHARMACEUTICALS LTD ADMINISTRA METERED
ICALS LTD ALS LTD ACTUATIO (UNIT III).-UNIT III VILLAGE TION DOSE
205 INDIA
2708 NDA/MAL/H GLAXOSMITH UNITED ALBEN ALBENDAZOL 400MG/10 PANACEA BIOTEC LTD- INDIA ORAL LIQUID 1.0X10.0 7/1/1999
DP/5400 KLINE HEALTHCARE SUSPENSIO E ML MALPUR, BADDI, TEHSIL, ORDINARY ML
PHARMACEUT DISTRIBUTORS N NALAGARH, DIST. SOLAN SUSPENSION BOTTLE
ICAL KENYA LTD (H.P) – 173 205 S
LTD
2709 NDA/MAL/H PIRAMAL TATA UGANDA HALOTHAN HALOTHANE 250ML PIRAMAL ENTERPRISES INDIA OTHER 1.0X250.0 7/1/2005
DP/5401 HEALTHCARE LIMITED E LTD --DIGWAL VILLAGE SYSTEMIC ML
LTD KOHIR MENDAL MEDAK LIQUID BOTTLE
DISTRICT,ANDHRA INHALATION
PRADESH S
2710 NDA/MAL/H INTAS, NORVIK HIFENAC P ACECLOFENA 100 MG + QIAGEN GMBH-SELAQUI INDIA ORAL SOLID 1.0X3.0X1 7/1/2013
DP/5404 PHARMACEUT ENTERPRISES C+ 500 MG DEHRADUN 248197 ORDINARY 0.0
ICALS LTD LIMITED PARACETAM TABLETS TABLET
OL BLISTER
2711 NDA/MAL/H CADILA ABACUS OLANDUS OLANZAPINE 10MG CADILA HEALTHCARE INDIA ORAL SOLID 1.0X10.0X 7/1/2005
DP/5405 HEALTHCARE PHARMA 10 LIMITED -KUNDAIM ORDINARY 10.0
LTD (AFRICA) INDUSTRIAL ESTATE,PLOT FILM- TABLET
2712 NDA/MAL/H INTAS, NORVIK HIFENAC SR ACECLOFENA 200 MG INTAS PHARMACEUTICALS INDIA ORAL SOLID 1.0X5.0X1 7/1/2007
DP/5406 PHARMACEUT ENTERPRISES C LIMITED(BIOPHARMA ORDINARY 0.0
ICALS LTD LIMITED DIVISION)-CAMP ROAD FILM- TABLET
SELAQUI-248197, COATED BLISTER
DEHRADUN TABLETS
(UTTARAKHAND) INDIA
2713 NDA/MAL/H LINCON METRO MINTO GEL ALUMINIUM 150 MG + SAKAR HEALTH CARE PVT, INDIA ORAL LIQUID 1.0X180.0 7/1/2012
DP/5409 PHARMCUETI PHARMACEUTIC HYDROXIDE + 150 MG + LTD-BLOCK NO. 10-13,M.N ORDINARY ML
CALS LIMITED ALS LIMITED MAGNESIUM 25 MG DESAI PETROL SUSPENSION BOTTLE
HYDROXIDE + PUMP,SARKHEJ-BAVLA S
SIMETHICONE ROAD,VILLAGE
CHANGODAR DIST
AHMEDABAD 382-
213,GUJARAT-INDIA
2714 NDA/MAL/H MEDICAL KARURI UNICTAM AMPICILLIN + 1000 MG + MEDICAL UNION EGYPT PARENTERAL 1.0X1.0 7/1/2009
DP/5410 UNION PHARMACEUTIC 1500 SULBACTAM 500 MG PHARMACEUTICALS LTD - - ORDINARY VIAL
PHARMACEUT ALS LTD. ABU SULTAN, CR 13363 DRY VIALS CARTON
ICALS ISMAILLIA, EGYPT
2715 NDA/MAL/H PASTEUR LABOREX EUVAX B HEPATITIS B 1ML PASTEUR MERIEUX SOUTH PARENTERAL 1.0X10.0 7/1/2007
DP/5413 MERIEUX UGANDA (ADULT) VACCINE CONNANGHT-SOUTH KOREA ORDINARY I ML
CONNANGHT LIMITED KOREA LG LIFE SCIENCES M VIALS VIAL,1.0X
LTD- 601, YONGJEI-DONG, 1.0 ML
IKSAN, JE VIAL
2716 NDA/MAL/H ACINO GOODMAN XYLO- XYLOMETAZO 0.1 % W/V MERCKLE GMBH,-LUDWIG GERMANY NASAL 1.0X1.0X1 7/1/2007
DP/5414 PHARMA AG INTERNATIONAL ACINO 0.1% LINE MERCKLE STRASSE3 D- TOPICAL 0.0 ML
LTD 89143 BLAUBEUREN DROPS BOTTLE
2717 NDA/MAL/H CENTAUR GITTOES SINAREST OXYMETAZOL 0.05%W/V CENTAUR INDIA NASAL 1.0X10.0 7/1/2009
DP/5415 PHARMACEUT PHARMACEUTIC INE PHARMACEUTICALS PVT TOPICAL ML VIAL
ICALS PVT LTD ALS LIMITED LTD --PLOT NO.3 TIVIN DROPS
INDUSTRIAL ESTATE
KARASWADA 403526
INDIA
2718 NDA/MAL/H OTSUKA REDDYS CIPROX CIPROFLOXAC 0.2%W/V OTSUKA INDIA PARENTERAL 1.0X100.0 7/1/2005
DP/5416 PHARMACEUT PHARMA IN PHARMACEUTICAL INDIA ORDINARY ML
ICAL INDIA LIMITED PRIVATE LTD-VILLAGE – INFUSION BOTTLE
PRIVATE VASANA – VIALS/BOTTL
LIMITED CHACHARWADIP, TAL: ES
SANAND, AHMADABAD
2719 NDA/MAL/H PHARMA OMAB UGANDA CIPROPHAR CIPROFLOXAC 500MG PHARMA INTERNATIONAL JORDAN ORAL SOLID 1.0X10.0 7/1/2007
DP/5417 INTERNATION LIMITED M IN COMPANY-MAIN STREET, ORDINARY TABLET
AL CO AL QASTAL INDUSTRIAL FILM- BLISTER
JORDAN TABLETS
2720 NDA/MAL/H MACLEODS NORVIK PAEDIATRIC CO- 240MG/5 MACLEODS INDIA ORAL LIQUID 1.0X100.0 7/1/2005
DP/5418 PHARMACEUT ENTERPRISES CO- TRIMOXAZOL ML PHARMACEUTICALS ORDINARY ML
ICALS LTD LIMITED TRIMOXAZ E LTD(BLOCK N2)-VILLAGE SUSPENSION BOTTLE
OLE THEDA,P.O LODHI S
MAJRA,TEHSIL
BADDI,HIMACHAL
PRADESH 174101
2721 NDA/MAL/H GITTOES GITTOES AGO-CPM CHLORPHENI 4MG AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1.0X10.0X 7/1/2005
DP/5419 PHARMACEUT PHARMACEUTIC RAMINE NO.33,SECTOR ORDINARY 10.0
E INDIA TABLET
CONTAIN
ER,1.0X10
0.0X10.0
TABLET
BLISTER
2722 NDA/MAL/H MICRO LABS PHARMA VILLE EFAVIRENZ EFAVIRENZ 200MG MICRO LABS LTD-92, INDIA ORAL SOLID 1.0X90.0 7/1/2014
DP/5420 LTD LIMITED SIPCOT INDUSTRIAL ORDINARY CAPSULE
COMPLEX HOSU R-635126 CAPSULES CONTAIN
(T.N) INDIA ER
2723 NDA/MAL/H MICRO LABS PHARMA VILLE EFAVIRENZ EFAVIRENZ 50MG MICRO LABS LTD-92, INDIA ORAL SOLID 1.0X30.0 7/1/2014
DP/5421 LTD LIMITED SIPCOT INDUSTRIAL ORDINARY CAPSULE
COMPLEX HOSU R-635126 CAPSULES CONTAIN
(T.N) INDIA ER
2724 NDA/MAL/H KOTRAPHAR ABACUS VAXCEL CEFUROXIME 750MG KOTRA PHARMA (M) SDN. MALAYSIA PARENTERAL 1.0X10.0 7/1/2008
DP/5422 MA (M) PHARMA CEFUROXI BHD-1 JALAN TTC 12, ORDINARY ML VIAL
SDN.BHD (AFRICA) ME-750 CHENG INDUSTRIAL VIALS
MALYSIA
2725 NDA/MAL/H HETERO LABS AIVEEN (U) EFAVIRENZ EFAVIRENZ+L 600MG/30 HETERO DRUGS LTD-UNIT- INDIA ORAL SOLID 1.0X30.0 7/1/2013
DP/5423 LTD LIMITED +LAMIVUDI AMIVUDINE+ 0MG/300 111 NO 22-110 I.D.A ORDINARY TABLET
NE+TENOF TENOFOVIR MG JEEDIMETTA HYDRABAD TABLETS CONTAIN
OVIR 500055 HETERO LABS ER,1.0X90
LTD. UNIT (V) .-S.N0.439, .0 TABLET
440, 441& 458, APIIC, JAR,1.0X1
PHARMA SEZ, 00.0
POLLEPALLY (VILLAGE), TABLET
JADCHERLA (MANDAL) JAR
509301 INDIA.
2726 NDA/MAL/H ROYAL HARLEYS PARACETA PARACETAM 500MG HEBEI (JIHENG GRP) CHINA ORAL SOLID 1.0X10.0X 7/1/2014
DP/5425 GROUP UGANDA MOL OL PHARMACEUTICALS ORDINARY 10.0
LIMITED CO.LTD-INDIA TABLETS TABLET
BLISTER
2727 NDA/MAL/H INDOCO STAR CEPROLEN CIPROFLOXAC 0.3%W/V INDOCO REMEDIES LTD---L- INDIA OPHTHALMI 1.0X5.0 7/1/2006
DP/5426 REMEDIES PHARMACEUTIC IN 32, 33 & 34, VERNA IND. C DROPS ML
LTD ALS LTD AREA, VERNA GOA-403722 BOTTLE
2728 NDA/MAL/H NIRMA LIFE PHARMA NIRCIP CIPROFLOXAC 200MG/10 ACULIFE HEALTHCARE INDIA PARENTERAL 1.0X100.0 7/1/2010
DP/5427 LIMITED. AFRICA LIMITED IN 0MG PVT. LTD-VILLAGE ORDINARY ML
SACHANA ,TALUKA - INFUSION BOTTLE
VIRAMGAM , VIALS/BOTTL
AHMEDABAD 382150 ES
GUJARAT
2729 NDA/MAL/H GITTOES GITTOES CIPRO-500 CIPROFLOXAC 500MG AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1.0X100.0 7/1/2006
DP/5429 PHARMACEUT PHARMACEUTIC IN NO.33,SECTOR ORDINARY X10.0
E INDIA .0 TABLET
BLISTER,1.
0X1000.0
TABLET
CONTAIN
ER,1.0X10
0.0
2730 NDA/MAL/H AUROBINDO GITTOES ZIDOVUDIN ZIDOVUDINE 300MG AUROBINDO PHARMA LTD- INDIA ORAL SOLID 1.0X60.0 7/1/2005
DP/5431 PHARMA LTD PHARMACEUTIC E UNIT III-SURVEY ORDINARY TABLET
ALS LIMITED NO.313,BACHUPALLY TABLETS BOTTLE
VILLAGE,QUTHUBULLAPU
R MANDAL R.R
DISTRICT(A.P),INDIA
2731 NDA/MAL/H MEDIPHARM MEDIPHARM ORALYTE DT ZINC-20 + 20G MEDIPHARM INDUSTRIES( INDIA ORAL SOLID 1.0X2.0X2 7/1/2016
DP/5434 (EA) LTD INDUSTRIES CO-PACK ORAL EA) LTD-PLOT 65 KAKAJJO ORDINARY 0.5 G
(E.A) LTD REHYDRATIO ROAD BWEYOGERERE OTHER SACHET +
N SALTS P.O.BOX SPECIAL 1.0*10.0
(ORS) 6218,KAMPALA,UGANDA FORMS TABLET
AGOG PHARMA LTD-PLOT BLISTER
NO.33,SECTOR
II,VASAI,TALUKA INDL CO-
E INDIA
2732 NDA/MAL/H GITTOES GITTOES PIC PARACETAM 500MG+20 AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1.0X25.0X 7/1/2015
DP/5435 PHARMACEUT PHARMACEUTIC OL+IBUPROFE 0MG+30M NO.33,SECTOR ORDINARY 4.0
ICALS LIMITED ALS LIMITED N+CAFFEINE G II,VASAI,TALUKA INDL CO- TABLETS TABLET
OP ESTATE LTD,GAURAI STRIP
E INDIA
2733 NDA/MAL/H CADILA ESCORTS CEFICAD CEFEPIME 1000MG CADILA INDIA PARENTERAL 1.0X1.0X1 7/1/2009
DP/5436 PHARMACEUT PHARMACEUTIC 1000 HCL PHARMACEUTICALS LTD. .- ORDINARY 000.0 MG
ICALS LIMITED ALS LIMITED 1389, TRASAD ROAD, DRY VIALS VIAL
DHOLKA-387810, GUJARAT
STATE
2734 NDA/MAL/H MEDIPHARM MEDIPHARM ORALYTE GLUCOSE/NA 13.5G/ MEDIPHARM INDUSTRIES UGANDA ORAL SOLID 1.0X20.8 7/1/2011
DP/5437 (EA) LTD INDUSTRIES ORANGE CL/TRISODIU 2.6G/ (E.A) LTD-PLOT 65, ORDINARY G
(E.A) LTD M 2.9G/ 1.5G KAKAJJO ROAD, POWDERS SACHET,1.
CITRATE/KCL BWEYOGERERE 0X10.4 G
SACHET
2735 NDA/MAL/H ELDA REDDYS TAMIN PARACETAM 10MG/ML CLARIS INJECTABLES INDIA PARENTERAL 1.0X100.0 7/1/2013
DP/5438 INTERNATION PHARMA OL LIMITED---CHACHARWADI ORDINARY ML
AL DMCC LIMITED VASANA 382 213 INFUSION BOTTLE,1.
AHMEDABAD GUJARAT VIALS/BOTTL 0X1.0X50.
ES 0 ML
BOTTLE,1.
0X1.0X100
.0 ML
VIAL
2736 NDA/MAL/H RENE RENE RENIRON VITAMIN B6 + 2MG/5ML RENE INDUSTRIES LTD- UGANDA ORAL LIQUID 1.0X100.0 7/1/2001
DP/5439 INDUSTRIES INDUSTRIES SYRUP FERROUS + PLOT 680, KAMULI ROAD, ORDINARY ML
LTD LIMITED GLUCONATE 200MG/5 KIREKA, P.O BOX 6034, SYRUPS BOTTLE
+ VITAMIN B1 ML + KAMPALA
+ VITAMIN C 2MG/5ML
+ VITAMIN B2 +
20MG/5ML
+
2MG/5ML
2737 NDA/MAL/H KOTRA ABACUS AXCEL PARACETAM 500MG+4 KOTRA PHARMA (M) SDN. MALAYSIA ORAL SOLID 1.0X10.0X 7/1/2008
DP/5441 PHARMA (M) PHARMA NASATAB OL+CHLORPH MG+60MG BHD-1 JALAN TTC 12, ORDINARY 100.0
SDN,BHD (AFRICA) TABLETS ENIRAMINE+ CHENG INDUSTRIAL TABLETS TABLET
LIMITED PSEUDOEPHE ESTATE, 75250 MELAKA BLISTER,1.
DRINE MALYSIA 0X10.0X10
.0 TABLET
BLISTER
2738 NDA/MAL/H SHOSAAN RENE CHLORAMP CHLORAMPH 1%W/W NEM LABORATORIES PVT INDIA OPHTHALMI 1.0X20.0X 7/1/2013
DP/5442 ASIC PACIFIC PHARMACY LTD HENICOL ENICOL LTD-133 KRISHNA C 3.5 G
OPHTHALM INDUSTRIAL ESTATE VASAI OINTMENTS TUBE
IC (E) DIST THANE 401 210
OINTMENT MAHARASHTRA
USP 1%
2739 NDA/MAL/H TRIVENI AIVEEN (U) DICLOFENA DICLOFENAC 50MG TRIVENI FORMULATION INDIA ORAL SOLID 1.0X100.0 7/1/2012
DP/5447 FORMULATIO LIMITED C SODIUM LTD-PLOT ORDINARY TABLET
NS LIMITED NO.52,53,54,63,62,64, TABLETS CARTON,1
ALEAP INDUSTRIAL .0X10.0X1
ESTATE SURAMPALI, 0.0
AP-INDIA – 521212 TABLET
BLISTER
2740 NDA/MAL/H GENO HARLEYS FLUNER-5 FLUNARIZINE 5MG GENO PHARMACEUTICALS INDIA ORAL SOLID 1.0X2.0X5 7/1/2011
DP/5448 PHARMACEUT UGANDA LTD--PHARMACEUTICAL ORDINARY .0X10.0
ICALS PVT LTD LIMITED COMPLEX, TIVIM TABLETS TABLET
INDUSTRIAL ESTATE, P.O. BLISTER
KARASWADA, MAPUSA,
GOA 403526
2741 NDA/MAL/H HOVID BHD UNITED CLOFENAC DICLOFENAC 50MG HOVID BERHAD (CHEMOR MALAYSIA ORAL SOLID 1.0X10.0X 7/1/2010
DP/5449 HEALTHCARE 50 SODIUM SITE)--LOT 56442, 71/2, ORDINARY 10.0
DISTRIBUTORS JALAN IPOH/CHEMOR ENTERIC- TABLET
LTD 31200, PERAK. MALAYSIA COATED BLISTER
TABLETS
2742 NDA/MAL/H PHARCO WIDE FARCONCIL AMOXICILLIN 250MG/5 PHARCO EGYPT ORAL LIQUID 1.0X10.0 7/1/1998
ICALS LTD ENTERPRISES L KILO 31 ALEXANDRIA, DRY BOTTLE
ALEXANDRIA EGYPT
2743 NDA/MAL/H LEBEN ANDYCO MOXILEB AMOXICILLIN 125MG/5 LEBEN LABORATORIES INDIA ORAL SOLID 1.0X100.0 7/1/2010
DP/5454 LABORATORIE PHARMACY ML PVT. LTD-PLOT NO. L-4, ORDINARY ML
S PVT.LTD (UGANDA) LTD PHASE-III, MIDC, POWDERS BOTTLE
AKOLA– 444 104 (MS).
2744 NDA/MAL/H PHARCO WIDE FARCONCIL AMOXICILLIN 125MG/5 PHARCO EGYPT ORAL LIQUID 1.0X100.0 7/1/1998
ICALS LTD ENTERPRISES L KILO 31 ALEXANDRIA, DRY BOTTLE
ALEXANDRIA EGYPT
2745 NDA/MAL/H CIPLA QUALITY FALCIMON ARTESUNATE 100MG+27 CIPLA LTD UNIT II-A-42 INDIA ORAL SOLID 1.0X3.0 7/1/2014
DP/5457 LIMITED CHEMICALS LTD - 100/270 +AMODIAQUI 0MG MIDC PATALGANGA ORDINARY TABLET
HUMAN B/L NE DISTRICT RAIGAD TABLETS BLISTER,1.
MAHARASHTRA STATE 0X6.0
TABLET
BLISTER,1.
0X25.0X3.
0 TABLET
BLISTER,1.
0X25.0X6.
0 TABLET
BLISTER
2746 NDA/MAL/H CIPLA LTD QUALITY FALCIMON ARTESUNATE 50MG+135 CIPLA LTD UNIT II-A-42 INDIA ORAL SOLID 1.0X3.0 7/1/2014
DP/5458 CHEMICALS LTD - 50/135 B/L +AMODIAQUI MG MIDC PATALGANGA ORDINARY TABLET
HUMAN NE DISTRICT RAIGAD TABLETS BLISTER,1.
MAHARASHTRA STATE 0X25.0X3.
0 TABLET
BLISTER
2747 NDA/MAL/H GUILIN STAR ASAQ GPSC ARTESUNATE 50MG+135 GUILIN CHINA ORAL SOLID 1.0X1.0X3 7/1/2011
DP/5460 PHARMACEUT PHARMACEUTIC +AMODIAQUI MG PHARMACEUTICALS CO. ORDINARY .0X20.0
ICALS CO.LTD ALS LTD NE LTD-NO 43 SHANGHAI TABLETS TABLET
ROAD GUILIN GUANGXI BLISTER,1.
CHINA 0X25.0X3.
0 TABLET
BLISTER,1.
0X25.0X6.
0 TABLET
BLISTER
2748 NDA/MAL/H SANOFI SURGIPHARM ARTESUNA ARTESUNATE 25MG+67. MAPHAR S.A. GROUP OF MOROCCO ORAL SOLID 1.0X25.0X 7/1/2008
DP/5461 AVENTIS (U) LIMITED TE +AMODIAQUI 5MG SANOFI,-KM 10, ROUTE ORDINARY 3.0
AMODIAQU NE COTIERE 111 QUARTIER, LAYERED TABLET
INE INDUSTRIEL ZENATA AIRI TABLETS BLISTER,1.
SEBAA, 00212522678099 - 0X3.0
MOROCCO TABLET
BLISTER
2749 NDA/MAL/H SANOFI SURGIPHARM ARTESUNA ARTESUNATE 50MG+135 MAPHAR S.A. GROUP OF MOROCCO ORAL SOLID 1.0X25.0X 7/1/2010
DP/5462 AVENTIS (U) LIMITED TE +AMODIAQUI MG SANOFI,-KM 10, ROUTE ORDINARY 3.0
AMODIAQU NE COTIERE 111 QUARTIER, TABLETS TABLET
INE INDUSTRIEL ZENATA AIRI BLISTER,1.
WINTHROP SEBAA, 00212522678099 - 0X3.0
MOROCCO TABLET
BLISTER
2750 NDA/MAL/H SANOFI SURGIPHARM ARTESUNA ARTESUNATE 100MG+27 MAPHAR S.A. GROUP OF MOROCCO ORAL SOLID 1.0X25.0X 7/1/2008
DP/5463 AVENTIS (U) LIMITED TE +AMODIAQUI 0MG SANOFI,-KM 10, ROUTE ORDINARY 3.0
AMODIAQU NE COTIERE 111 QUARTIER, LAYERED TABLET
INE INDUSTRIEL ZENATA AIRI TABLETS BLISTER,1.
WINTHROP SEBAA, 00212522678099 - 0X25.0X6.
MOROCCO 0 TABLET
BLISTER,1.
0X6.0
TABLET
BLISTER,1.
0X3.0
TABLET
2751 NDA/MAL/H GITTOES GITTOES CO- ARTEMETHER 20MG + AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1.0X3.0X4 7/1/2007
DP/5464 PHARMACEUT PHARMACEUTIC METHER + 120MG NO.33,SECTOR ORDINARY .0 TABLET
ICALS LIMITED ALS LIMITED LUMEFANTRI II,VASAI,TALUKA INDL CO- TABLETS BLISTER,1.
NE OP ESTATE LTD,GAURAI 0X3.0X8.0
E INDIA BLISTER,1.
0X6.0
TABLET
BLISTER,2.
0X6.0
TABLET
BLISTER,4.
2752 NDA/MAL/H KAMPALA KAMPALA KAMSIDAR SULFADOXINE 525MG KAMPALA UGANDA ORAL SOLID 1.0X10.0 7/1/1997
DP/5467 PHARMACEUT PHARMACEUTIC /PYRIMETHA PHARMECEUTICALS ORDINARY TABLET
ICAL AL INDUSTRIES MINE INDUSTRIES LTD.-PLOT TABLETS BLISTER,1.
INDUSTRIES 1996 LIMITED M444B STRETCHER RD, 0X100.0
1996 LIMITED NTINDA KLA UGANDA TABLET
CARTON,1
.0X250.0
TABLET
CONTAIN
ER,1.0X50
0.0
TABLET
2753 NDA/MAL/H BAYER SURGIPHARM NIMOTOP NIMODIPINE 0.2MG/ML BAYER PHARMA AG - GERMANY PARENTERAL 1.0X50.0 7/1/2009
DP/5469 PHARMA AG (U) LIMITED 51368 LEVERKUSEN ORDINARY I ML VIAL
GERMANY V VIALS
2754 NDA/MAL/H MICRO LABS LABOREX AVAS 40 ATORVASTATI 40MG MICRO LABS LTD-92, INDIA ORAL SOLID 1.0X3.0X1 7/1/2013
DP/5471 LTD UGANDA N SIPCOT INDUSTRIAL ORDINARY 0.0
LIMITED COMPLEX HOSU R-635126 TABLETS TABLET
(T.N) INDIA BLISTER
2755 NDA/MAL/H CLARIS REDDYS NS SODIUM 0.9%W/V OTSUKA INDIA PARENTERAL 1.0X250.0 7/1/2007
DP/5472 OTSUKA PHARMA CHLORIDE PHARMACEUTICAL INDIA ORDINARY ML
LIMITED LIMITED PRIVATE LTD-VILLAGE – INFUSION BOTTLE,1.
VASANA – VIALS/BOTTL 0X500.0
CHACHARWADIP, TAL: ES ML
SANAND, AHMADABAD BOTTLE,1.
0X100.0
ML BAG
2756 NDA/MAL/H TROIKAA ABACUS TROYPOFOL PROPOFOL 1%W/V TROIKAA INDIA PARENTERAL 1.0X50.0 7/1/2012
DP/5473 PHARMACEUT PHARMA PHARMACEUTICALS LTD .- ORDINARY ML
ICALS LIMITED (AFRICA) C-1 SARA INDUSTRIAL VIALS VIAL,1.0X
LIMITED ESTATE SELAQUI 20.0 ML
DEHRADUN 248197 VIAL
2757 NDA/MAL/H PHARMA OMAB UGANDA CEFODOX CEFPODOXIM 200MG PHARMA INTERNATIONAL JORDAN ORAL SOLID 1.0X1.0X1 7/1/2005
DP/5474 INTERNATION LIMITED E PROXETIL CO.-AMMAN JORDAN ORDINARY 0.0
AL.CO PLANT FILM- TABLET
AL-QARTAL MARKETING COATED BLISTER
DEPARTMENT TABLETS
ALBUJAH COMPLEX,
ALJUBAIHA
2758 NDA/MAL/H KOTRA ABACUS VAXCEL CEFTAZIDIME 1G KOTRA PHARMA (M) MALAYSIA PARENTERAL 1.0X1.0 G 7/1/2013
DP/5475 PHARMA (M) PHARMA CEFTAZIDI SDN.BHD,-1,2 & 3 JALAN ORDINARY VIAL
SDN,BHD (AFRICA) ME TTC 12 CHENG DRY VIALS
LIMITED INDUSTRIAL ESTATE 75250
MELAKA
2759 NDA/MAL/H ACINO GOODMAN MESPORIN CEFTRIAXONE 1000MG LABESFAL LABORATORIES- PORTUGAL PARENTERAL 1.0X1000. 7/1/2002
DP/5476 PHARMA AG INTERNATIONAL 1000MG I.V ALMIRO S.A ZONA ORDINARY 0 MG VIAL
LTD INDUSTRIAL DO LAGEDO, DRY VIALS + 10 ML
3465-157, SANTIAGO DE WFI
BESTERIROS PORTUGAL
2760 NDA/MAL/H CIPLA LTD QUALITY BECLATE-50 BECLOMETHA 50MCG/AC CIPLA LTD.- -PLOT NO INDIA LUNG 1.0X1.0X2 7/1/2010
DP/5478 CHEMICALS LTD - SONE TUATION L/139 TO L/146, VERNA ADMINISTRA 00.0
HUMAN DIPROPIONAT INDUSTRIAL ESTATE, TION METERED
E VERNA, SOUTH GOA METERED- DOSE
DISTRICT, 403722 GOA DOSE CANNISTE
INHALER R
2761 NDA/MAL/H SUN STAR RANFERON MULTI- MULTI- SUN PHARMACEUTICAL INDIA ORAL SOLID 1.0X30.0 7/1/1997
DP/5479 PHARMACEUT PHARMACEUTIC 12 INGREDIENT INGREDIEN INDUSTRIES LIMITED,- ORDINARY CAPSULE
ICAL ALS LTD CAPSULES T INDUSTRIAL AREA NO.3, CAPSULES BLISTER
INDUSTRIES A.B.ROAD DEWAS,455001
LIMITED MADHYA PRADESH INDIA.
2762 NDA/MAL/H GITTOES GITTOES AGO-LIN SALBUTAMOL 2MG/5ML AGOG PHARMA LTD-PLOT INDIA ORAL LIQUID 1.0X1.0X1 7/1/2010
DP/5482 PHARMACEUT PHARMACEUTIC NO.33,SECTOR ORDINARY 00.0 ML
E INDIA
2763 NDA/MAL/H GUILIN STAR ASAQ GPSC ARTESUNATE 25 MG + GUILIN CHINA ORAL SOLID 1.0X1.0X3 7/1/2011
DP/5483 PHARMACEUT PHARMACEUTIC + 67.5 MG PHARMACEUTICALS CO. ORDINARY .0X20.0
ICALS CO.LTD ALS LTD AMODIAQUIN LTD-NO 43 SHANGHAI TABLETS TABLET
E ROAD GUILIN GUANGXI BLISTER,1.
CHINA 0X25.0X3.
0 TABLET
BLISTER,1.
0X25.0X6.
0 TABLET
BLISTER
2764 NDA/MAL/H EMCURE HARLEYS FOSEAL 400 SEVELAMER 400MG EMCURE INDIA ORAL SOLID 1.0X10.0 7/1/2009
DP/5486 PHARMACEUT UGANDA HCL PHARMACEUTICALS LTD .- ORDINARY TABLET
ICALS LTD LIMITED C-10(12) MIDC BHOSAN FILM- BLISTER,1.
PUNE COATED 0X6.0X10.
TABLETS 0 TABLET
BLISTER
2765 NDA/MAL/H GLENMARK STAR IBICAR-S SALBUTAMOL 100MCG/A GLENMARK INDIA LUNG 1.0X200.0 7/1/2013
DP/5487 PHARMACEUT PHARMACEUTIC + CTUATION PHARMACEUTICALS LTD ADMINISTRA METERED
ICALS LTD ALS LTD BECLOMETAS + (UNIT III).-UNIT III VILLAGE TION CFC- DOSE
ONE 50MCG/AC KISHANPURA,BADDI- FREE CANNISTE
TUATION NALAGARH ROAD TEHSIL METERED- R
BADDI,DISTT. SOLAN, DOSE
HIMACHAL PRADESH -173 INHALER
205 INDIA
2766 NDA/MAL/H UNICHEM EUROPA CORBIS-5 BISOPROLOL 5MG UNICHEM LABORATORIES INDIA ORAL SOLID 1.0X3.0X1 7/1/2008
S LTD (U) LTD BHATAULI KALAN BADDI FILM- TABLET
DIST SOLAN HIMACHAL COATED STRIP
2767 NDA/MAL/H ASTRA MACNAUGHTON ATACAND CANDESARTA 16MG ASTRA ZENECA AB-SE-151 SWEDEN ORAL SOLID 1.0X2.0X1 7/1/2010
DP/5496 ZENECA LIMITED 16MG N CILEXETIL 85 SODERTALJE, SWEDEN ORDINARY 4.0
(GARTUNAVAGEN & TABLETS TABLET
SNACKVIKEN) BLISTER
2768 NDA/MAL/H GALENTIC NORVIK CALADIN CALAMINE 15 %W/W GALENTIC PHARMA( INDIA INDIA TOPICAL 1.0X100.0 7/1/2001
DP/5507 PHARMA LTD ENTERPRISES LOTION ) PVT LTD-R-673,MIDC TTC EXTERNAL ML
LIMITED RABALE THANE-BELAPUR LOTIONS BOTTLE,1.
ROAD,NAVI 0X60.0 ML
BOTTLE
2769 NDA/MAL/H UMEDICA VITACARE RILIF-SR ACECLOFENA 200 MG UMEDICA LABORATORIES INDIA ORAL SOLID 1.0X3.0X1 7/1/2011
DP/5525 LABS PVT LTD LIMITED C PVT LTD-PLOT NO. 221, ORDINARY 0.0
2ND PHASE, GIDC, VAPI TABLETS TABLET
396195, GUJARAT. INDIA. BLISTER
2770 NDA/MAL/H SQUARE GAMA SILYBIN 70 SQUARE HERBAL & BANGLADESH ORAL SOLID CAPSULE 7/1/2014
DP/5543 HERBAL & PHARMACEUTIC NUTRACEUTICALS LTD-48 ORDINARY BLISTER
NUTRACEUTIC ALS (U) LIMITED MOHAKHALI CAPSULES
ALS COMMERCIAL AREA
2771 NDA/MAL/H SK AGE ABACUS HYOSCINE HYOSCINE 10MG S.KANT HEALTHCARE LTD- INDIA ORAL SOLID 1.0X10.0X 7/1/2011
DP/5575 EXPORTS PHARMA BUTYL BUTYL PLOT 1802, 1805, GIDC ORDINARY 10.0
(AFRICA) BROMIDE BROMIDE PHASE III VAPI 39179, FILM- TABLET
LIMITED GUJARAT COATED BLISTER,1.
TABLETS 0X100.0X1
0.0
TABLET
BLISTER
2772 NDA/MAL/H SWISS SHREEJI SWISSCILLI AMPICILLIN 500MG SWISS PARENTERALS LTD- INDIA PARENTERAL 1.0X500.0 7/1/2011
DP/5591 PARENTERALS PHARMACEUTIC N 809 KERALA IND ESTATE ORDINARY MG VIAL
AHMEDABAD 382220
GUJARAT INDIA
2773 NDA/MAL/H CADILA KARURI RABELOC RABEPRAZOL 20MG CADILA INDIA ORAL SOLID 1.0X1.0X1 7/1/2006
DP/5619 PHARMACEUT PHARMACEUTIC 20 E SODIUM PHARMACEUTICALS ORDINARY 0.0
ICALS LIMITED ALS LTD. LIMITED-1389, TRASAD ENTERIC- TABLET
ROAD, DHOLKA- 382225, COATED STRIP
STATE, INDIA
2774 NDA/MAL/H ATCO ABACUS BETADERM MICONAZOLE 2MG+0.5G ATCO LABORATORIES PVT PAKISTAN TOPICAL 1.0X10.0 7/1/2004
DP/5636 LABORATORIE PHARMA NM CREAM +NEOMYCIN + 0.1G LTD-B-18,S.I.T.E KARACHI, EXTERNAL G TUBE
S LTD (AFRICA) +BETAMETHA PAKISTAN CREAMS
LIMITED SONE
VALERATE
2775 NDA/MAL/H GITTOES GITTOES FORTIFIED FORTIFIED 4 MEGA CSPC ZHONGNUO CHINA PARENTERAL 1.0X4.0 7/1/2001
DP/5644 PHARMACEUT PHARMACEUTIC PROCAINE PROCAINE UNITS PHARMACEUTICAL ORDINARY MU VIAL
ICALS LIMITED ALS LIMITED PENICILLIN PENICILLIN (SCIJIAZHUANG) CO. LTD VIALS
WORKSHOP -NO. 88
YANGZI ROAD,
SHIJIAZHUANG CITY,
2776 NDA/MAL/H KARNATAKA TATA UGANDA CLOXACILLI CLOXACILLIN 500MG KARNATAKA ANTIBIOTICS INDIA PARENTERAL 1.0X10.0X 7/1/2010
DP/5648 ANTIBIOTICS LIMITED N SODIUM SODIUM & PHARMACEUTICALS LTD- ORDINARY 500.0 MG
& #14, II PHASE PIA, DRY VIALS VIAL
PHARMACEUT BANGALORE 560058
ICALS LTD
2777 NDA/MAL/H JOHNSON&JO PHILLIPS VERMOX MEBENDAZOL 20MG/5ML SPECPHARM HOLDINGS- SOUTH ORAL LIQUID 1.0X30.0 7/1/1998
DP/5685 HNSON PTY PHARMACEUTIC E 15TH ROAD HALFWAY AFRICA ORDINARY ML
LTD ALS (UGANDA) HOUSE SUSPENSION BOTTLE
LIMITED S
2778 NDA/MAL/H GITTOES GITTOES AGOXIN - AMOXICILLIN 250 MG MILAN LABS PVT LTD-63- INDIA ORAL SOLID 1.0X10.0 7/1/2016
DP/6034 PHARMACEUT PHARMACEUTIC 250 DT TRIHYDRATE 67 JAWAHAR CO.OP. ORDINARY TABLET
ICALS LIMITED ALS LIMITED INDUSTRIAL ESTATE ORALLY BLISTER,1.
KAMOTHE,NAVI MUMBAI DISINTEGRA 0X10.0X10
TING .0 TABLET
TABLETS BLISTER,1.
0X2.0X10.
0 TABLET
BLISTER
2779 NDA/MAL/H UNOSOURCE ABACUS OFLOTECH- OFLOXACIN + 200MG + AKUMS DRUGS & INDIA ORAL SOLID 1.0X10.0X 3/28/2019
DP/6036 PHARMA LTD. PHARMA O ORNIDAZOLE 500MG PHARMACEUTICALS LTD- ORDINARY 10.0
(AFRICA) 19-20,21, SECTOR 6-4, FILM- TABLET
LIMITED SIDCUL, IIE, RANIPUR COATED BLISTER
HARIDWAR-249403 TABLETS
2780 NDA/MAL/H GITTOES GITTOES AVIT VITAMIN A 200,000 IU OLIVE HEALTHCARE- INDIA ORAL SOLID 1.0X30.0 7/1/2017
DP/6037 PHARMACEUT PHARMACEUTIC 197/2, ATHIYAWAD ORDINARY CAPSULE
ICALS LIMITED ALS LIMITED DABHEL VILLAGE DAMAN CAPSULES BLISTER,1.
396210 (U.T) 0X10.0X10
.0
CAPSULE
BLISTER,1.
0X1000.0
CAPSULE
JAR
2781 NDA/MAL/H UMEDICA VITACARE FIXDEP-180 FEXOFENADI 180MG UMEDICA LABORATORIES INDIA ORAL SOLID 1.0X10.0 7/1/2017
DP/6038 LABORATORIE LIMITED NE PVT LTD-PLOT NO. 221, ORDINARY TABLET
S PVT LTD HYDROCHLOR 2ND PHASE, GIDC, VAPI FILM- BLISTER
IDE 396195, GUJARAT. INDIA. COATED
TABLETS
2782 NDA/MAL/H BHARAT ABACUS U-TRYP ULINASTATIN 100,000 I.U BHARAT SERUMS AND INDIA PARENTERAL 1.0X1.0 7/1/2017
DP/6040 SERUMS AND PHARMA VACCINES LIMITED,-PLOT ORDINARY VIAL
VACCINES LTD (AFRICA) NO. K-27, ADDITIONAL DRY VIALS CARTON
LIMITED MIDC,
AMBERNATH (EAST),
INDIA
2783 NDA/MAL/H GITTOES GITTOES CANDIZOL CLOTRIMAZO 100MG AGOG PHARMA LTD-PLOT INDIA VAGINAL 1.0X6.0 7/1/2017
DP/6041 PHARMACEUT PHARMACEUTIC LE NO.33,SECTOR TABLETS PESSARY
ICALS LIMITED ALS LIMITED II,VASAI,TALUKA INDL CO- STRIP
E INDIA
2784 NDA/MAL/H BHARAT ABACUS ZEMILAST IMIPENEM + 500MG+50 ZEISS PHARMACEUTICALS INDIA PARENTERAL 1.0X30.0 7/1/2017
DP/6043 SERUMS AND PHARMA CILASTATIN 0MG PVT. LIMITED-PLOT NO. ORDINARY ML
VACCINES LTD (AFRICA) 72, EPIP I, JHARMAJIRI, DRY VIALS BOTTLE
LIMITED BADDI (HP), INDIA
2785 NDA/MAL/H MYLAN KIMSY MEDS ACYCLOVIR ACYCLOVIR 200MG MYLAN LABORATORIES INDIA ORAL SOLID 1.0X10.0 7/1/2017
DP/6046 LABORATORIE LTD LIMITED.-PLOT NO. H-12 & ORDINARY TABLET
S LIMITED H-13 TABLETS BLISTER
AREA,
MAHARASHTRA STATE,
INDIA.
2786 NDA/MAL/H MYLAN KIMSY MEDS HERTRAZ TRASTUZUMA 150MG BIOCON LIMITED-SPECIAL INDIA PARENTERAL 1.0X150.0 7/1/2017
DP/6047 PHARMACEUT LTD 150 B (R-DNA ECONOMIC ZONE, ORDINARY MG VIAL
ICAL PRIVATE ORIGIN) PLOT NO.2-4, PHASE IV, INFUSION ,1X10ML
LIMITED, BOMMASANDRA- JIGANI DRY VIAL OF
INDIA LINK ROAD VIALS/BOTTL WFI
BANGALORE-560 099 ES
2787 NDA/MAL/H MICRO LABS LABOREX ITACARE ITRACONAZO 100MG MICRO LABS LTD 92 INDIA ORAL SOLID 1.0X3.0X1 7/1/2017
DP/6050 LTD UGANDA LE SIPCOT -92 SIPCOT ORDINARY 0.0
LIMITED HOSUR 635 126 TAMIL CAPSULES CAPSULE
NADU BLISTER,1.
0X10.0
CAPSULE
BLISTER
2788 NDA/MAL/H SANDOZ SURGIPHARM GLIMEPIRID GLIMEPIRIDE 4MG LEK S.S POLAND UI POLAND ORAL SOLID 1.0X9.0X1 7/1/2012
DP/6053 KENYA C/O (U) LIMITED E PODLIPIE 16 95-01O ORDINARY 0.0
NOVARTIS STRYKOW-INDUSTRIAL TABLETS TABLET
PHARMA ESTATES BLISTER
SERVICES INC
2789 NDA/MAL/H SANDOZ SURGIPHARM GLIMEPIRID GLIMEPIRIDE 1MG LEK S.S POLAND UI POLAND ORAL SOLID 1.0X9.0X1 7/1/2012
DP/6054 KENYA C/O (U) LIMITED E PODLIPIE 16 95-01O ORDINARY 0.0
NOVARTIS STRYKOW-INDUSTRIAL TABLETS TABLET
PHARMA ESTATES BLISTER,1.
SERVICES INC 0X3.0X10.
0 TABLET
BLISTER
2790 NDA/MAL/H SIGMA-TAU LABOREX EURARTESI PIPERAQUINE 160MG + SIGMA- TAU I.F.R . S.P.A- ITALY ORAL SOLID 1.0X3.0 7/1/2017
DP/6055 INDUSTRIE UGANDA M TETRAPHOSP 20MG VIA PONTINA KM 30,400 ORDINARY TABLET
FARMACEUTI LIMITED HATE + POMEZIA ROME TABLETS BLISTER
CHE RIUNITE DIHYDROART
S.P.A EMISININ
2791 NDA/MAL/H BROOKES HARLEYS CORAM AMLODIPINE 5MG BROOKES PAKISTAN ORAL SOLID 1.0X2.0X1 7/1/2009
DP/6057 PHARMACEUT UGANDA 5MG BESYLATE PHARMACEUTICALS ORDINARY 0.0
ICAL LIMITED LABORATORIES TABLETS TABLET
LABORATORIE (PAKISTAN) LTD-PLOT 58 BLISTER,1.
SL SECTOR 15 KORANGI 0X3.0X10.
INDUSTRIAL AREA, 0 TABLET
KARACHI-PAKISTAN BLISTER,1.
0X10.0X10
.0 TABLET
BLISTER
2792 NDA/MAL/H NOVARTIS SURGIPHARM SALBUTAM SALBUTAMOL 100MCG AEROPHARM GMBH...- GERMANY LUNG 1.0X200.0 7/1/2017
DP/6060 ACCESS (U) LIMITED OL RUDOLSTADT ALLEMAGNE ADMINISTRA METERED
TION LIQUID DOSE
FOR CONTAIN
INHALATION ER
2793 NDA/MAL/H CIPLA LTD.. QUALITY NASEHALER MOMETASON 50MCG CIPLA LTD INDORE-PLOT 9 INDIA NASAL 1.0X140.0 7/1/2017
DP/6061 CHEMICALS LTD - E FUROATE /SPRAY & 10 INDORE SEZ TOPICAL METERED
HUMAN PITHAMPUR M.P 454 775 SPRAYS DOSE
WITHOUT BOTTLE
GAS
2794 NDA/MAL/H RENE RENE PROXYREN PIROXICAM 20MG RENE INDUSTRIES LTD- UGANDA ORAL SOLID 1.0X10.0X 7/1/2017
LTD LIMITED KIREKA, P.O BOX 6034, CAPSULES CAPSULE
KAMPALA BLISTER
2795 NDA/MAL/H STEDMAN VEERAM DREZ IODINATED- 10%W/V STEDMAN INDIA TOPICAL 1.0X100.0 7/1/2017
DP/6066 PHARMACEUT HEALTHCARE POVIDONE PHARMACEUTICALS PVT EXTERNAL ML
ICALS PVT. (U) LIMITED LIMITED-NO. C-4, SIDCO LIQUIDS BOTTLE
LTD PHARMACEUTICAL
COMPLEX, ALATHUR,
THIRUPORUR,
2796 NDA/MAL/H DEVA SHREEJI VAZKOR AMLODIPINE 10MG DEVA HOLDING A.S- TURKEY ORAL SOLID 1.0X9.0X1 7/1/2017
DP/6070 HOLDING A.S PHARMACEUTIC BESILATE CERKEZKOY ORGANIZE ORDINARY 0.0
ALS LIMITED SANAYI BOLGESI, TABLETS TABLET
KARAAGAC MAH., BLISTER
ATATURK CAD., NO.: 32
KAPAKLI TEKIRDAG
2797 NDA/MAL/H DEVA SHREEJI VAZKOR AMLODIPINE 5MG DEVA HOLDING A.S- TURKEY ORAL SOLID 1.0X9.0X1 7/1/2017
DP/6071 HOLDING A.S PHARMACEUTIC BESILATE CERKEZKOY ORGANIZE ORDINARY 0.0
ALS LIMITED SANAYI BOLGESI, TABLETS TABLET
KARAAGAC MAH., BLISTER
KAPAKLI TEKIRDAG
2798 NDA/MAL/H SWISS SHREEJI HYDRALAZI HYDRALAZINE 20MG/ML SWISS PARENTERALS PVT INDIA PARENTERAL 1.0X5.0X1 7/1/2017
DP/6072 PARENTERALS PHARMACEUTIC NE HYDROCHLOR LTD.-809 KERALA IND ORDINARY I .0 ML
LTD ALS LIMITED HYDROCHL IDE ESTATE GIDC NEAR BAVLA V AMPOULES AMPOULE
ORIDE DIST AHMEDABAD 38222O ,1.0X10.0X
GUJARAT 1.0 ML
AMPOULE
2799 NDA/MAL/H EGYPTIAN WIDE OLOHISTIN OLOPATADIN 1MG/ML EGYPTIAN EGYPT OPHTHALMI 1.0X5.0 7/1/2017
DP/6075 INTERNATION SPECTRUM E E INTERNATIONAL C DROPS ML
AL ENTERPRISES HYDROCHLOR PHARMACEUTICAL BOTTLE
PHARMACEUT (U) LIMITED IDE INDUSTRIES COMPANY-
COMPANY
LTD ALS LIMITED GIDC NEAR BAVLA DIST DRY VIALS 1*5 ML
AHMEDABAD 382220 OF
GUJARAT INDIA 0.9%W/V
NACL
AMPOULE
+ 1*1 ML
OF
5%W/V
NAHCO3
AMPOULE
2801 NDA/MAL/H EGYPTIAN WIDE TIMOLOL TIMOLOL 5MG/ML EGYPTIAN EGYPT OPHTHALMI 1.0X5.0 7/1/2017
DP/6078 INTERNATION SPECTRUM MALEATE MALEATE INTERNATIONAL C DROPS ML
AL ENTERPRISES PHARMACEUTICAL BOTTLE
COMPANY
2802 NDA/MAL/H ADCOCK UGANDA ALLERGEX CHLORPHENI 4MG ADCOCK INGRAM LIMITED INDIA ORAL SOLID 1.0X3.0X1 7/1/2017
DP/6079 INGRAM HEALTH RAMINE -49C & D BOMMASANDRA ORDINARY 0.0
LIMITED MARKETING MALEATE INDUSTRIAL AREA ANEKAL TABLETS TABLET
GROUP LIMITED TALUK, BANGALORE BLISTER
560099, KARNATAKA
STATE, INDIA
2803 NDA/MAL/H EXPHAR SA SURGIPHARM FEBRILEX PARACETAM 125MG+1 GRACURE INDIA ORAL LIQUID 1.0X150.0 7/1/2017
DP/6080 (U) LIMITED JUNIOR OL+CHLORPH MG/5ML PHARMACEUTICAL LTD-E- ORDINARY ML
ENIRAMINE 1105, RIICO IND. AREA, SYRUPS BOTTLE
MALEATE PHASE III, BHIWADI,
DISTRICT ALWAR
(RAJASTHAN)
2804 NDA/MAL/H EXPHAR SA SURGIPHARM ANTALGEX PARACETAM 325MG/37. GRACURE INDIA ORAL SOLID 1.0X2.0X1 7/1/2017
DP/6081 (U) LIMITED T OL/TRAMADO 5MG PHARMACEUTICAL LTD-E- ORDINARY 0.0
L 1105, RIICO IND. AREA, CAPSULES CAPSULE
HYDROCHLOR PHASE III, BHIWADI, BLISTER
IDE DISTRICT ALWAR
(RAJASTHAN)
2805 NDA/MAL/H EXPHAR SA SURGIPHARM CROMSOL SODIUM 2%W/V AHLCONPARENTERALS INDIA OPHTHALMI 1.0X5.0 7/1/2017
DP/6082 (U) LIMITED CROMOGLYC (INDIA) LIMITED-SP-918, C DROPS ML
ATE PHASE-III, BHIWADI- BOTTLE
301019, RAJASTHAN
(INDIA)
TEL: +91-1493-305300 (30
LINES)
FAX: +91-1493-221045,
305345
2806 NDA/MAL/H UNOSOURCE ESCORTS ACEWEL-P ACECLOFENA 100MG+50 AKUMS DRUGS & INDIA ORAL SOLID 1.0X10.0 7/1/2017
DP/6086 PHARMA LTD PHARMACEUTIC C+PARACETA 0MG PHARMACEUTICALS LTD- ORDINARY TABLET
ALS LIMITED MOL 19, 20,21 SECTOR 6A IIE FILM- BLISTER,1.
SIDCUL RANIPUR COATED 0X10.0X10
HARIDWAR 249 403 TABLETS .0 TABLET
BLISTER
2807 NDA/MAL/H UNOSOURCE ESCORTS PROSTAR PROGESTERO 100MG/ML AKUMS DRUGS & INDIA PARENTERAL 1.0X5.0X2 7/1/2017
DP/6090 PHARMA LTD PHARMACEUTIC 200 NE PHARMACEUTICALS LTD .- ORDINARY .0 ML
ALS LIMITED 47, 48 SECTOR 6A I.I.E AMPOULES AMPOULE
SIDCUL RANIPUR
HARIDWAR 249 403
2808 NDA/MAL/H SPARSH BIO- ABACUS SPOTCLAV AMOXICILLIN 500 MG + SPARSH BIO-TECH PVT. INDIA ORAL SOLID 1.0X2.0X1 7/1/2017
DP/6093 TECH PVT LTD PHARMA 625 TRIHYDRATE 125 MG LIMITED-PLOT NO. ORDINARY 0.0
(AFRICA) + 1;SURVEY NO. FILM- TABLET
LIMITED CLAVULANAT 242/243/244,LAKHABAVA COATED BLISTER
E POTASSIUM D,JAMNAGAR-361 006, TABLETS
INDIA.
2809 NDA/MAL/H SPARSH BIO- ABACUS SPOTCLAV AMOXICILLIN 250 MG + SPARSH BIO-TECH PVT. INDIA ORAL SOLID 1.0X2.0X1 7/1/2017
DP/6094 TECH PVT LTD PHARMA 375 TRIHYDRATE 125 MG LTD-PLOT NO. 1; SURVEY ORDINARY 0.0
(AFRICA) + NO. 242/243/244, FILM- TABLET
LIMITED CLAVULANAT LAKHABAVAD, COATED BLISTER
E POTASSIUM JAMNAGAR-361 006, TABLETS
INDIA
2810 NDA/MAL/H ABACUS ABACUS HARIPIL-60 ARTESUNATE 60MG PSYCHOTROPICS INDIA INDIA PARENTERAL 1.0X60.0 7/1/2017
DP/6099 PHARMA (A) PHARMA LTD -PLOT NO. 12 & 12A, ORDINARY MG VIAL +
LTD. (AFRICA) INDUSTRIAL PARK-II, DRY VIALS 1*5 ML
LIMITED PHASE-1, VILLAGE OF 0.9%
SALEMPUR, MEHDOOD-2 W/V NACL
HARIDWAR-249403, GLASS
UTTARAKHAND INDIA AMPOULE
+ 1*1 ML
OF
5%W/V
NAHCO3
GLASS
2811 NDA/MAL/H ABACUS ABACUS TELPRESS-H TELMISARTA 40MG + PSYCHOTROPICS INDIA INDIA ORAL SOLID 1.0X3.0X1 7/1/2017
DP/6101 PHARMA (A) PHARMA 40/12.5 N+ 12.5MG LTD-PLOT NO. 46 & 49 ORDINARY 0.0
LTD. (AFRICA) HYDROCHLOR SECTOR -6A IIE SIDCUL LAYERED TABLET
LIMITED OTHIAZIDE RANIPUR HARIDWAR TABLETS BLISTER
249403 UTTARAKHAND
2812 NDA/MAL/H ABACUS ABACUS TELPRESS TELMISARTA 80MG PSYCHOTROPICS INDIA INDIA ORAL SOLID 1.0X3.0X1 7/1/2017
DP/6102 PHARMA (A) PHARMA 80 N LTD-PLOT NO. 46 & 49 ORDINARY 0.0
LTD. (AFRICA) SECTOR -6A IIE SIDCUL TABLETS TABLET
LIMITED RANIPUR HARIDWAR BLISTER
249403 UTTARAKHAND
2813 NDA/MAL/H ABACUS ABACUS OZACE MD OLANZAPINE 5MG PSYCHOTROPICS INDIA INDIA ORAL SOLID 1.0X10.0X 7/1/2017
DP/6103 PHARMA (A) PHARMA 5 LTD-PLOT NO. 46 & 49 ORDINARY 10.0
LTD. (AFRICA) SECTOR -6A IIE SIDCUL TABLETS TABLET
LIMITED RANIPUR HARIDWAR BLISTER
249403 UTTARAKHAND
2814 NDA/MAL/H ABACUS ABACUS FUROSEMI FUROSEMIDE 10MG/ML PSYCHOTROPICS INDIA INDIA PARENTERAL 1.0X10.0X 7/1/2017
DP/6104 PHARMA (A) PHARMA DE LTD -PLOT NO. 12 & 12A, ORDINARY I 10.0X2.0
LTD. (AFRICA) INDUSTRIAL PARK-II, V AMPOULES ML
LIMITED PHASE-1, VILLAGE AMPOULE
SALEMPUR, MEHDOOD-2
HARIDWAR-249403,
UTTARAKHAND INDIA
2815 NDA/MAL/H ABACUS ABACUS AZOPIL 200 AZITHROMYCI 200MG/5 PSYCHOTROPICS INDIA INDIA ORAL LIQUID 1.0X15.0 7/1/2017
DP/6105 PHARMA LTD PHARMA N ML LTD-PLOT NO. 46 & 49 ORDINARY ML
(AFRICA) SECTOR -6A IIE SIDCUL SUSPENSION BOTTLE
LIMITED RANIPUR HARIDWAR S
249403 UTTARAKHAND
2816 NDA/MAL/H SQUARE GAMA SULPREX IPRATROPIU 500MCG/2. SQUARE BANGLADESH LUNG 1.0X10.0 7/1/2017
DP/6107 PHARMACEUT PHARMACEUTIC M 5ML+2.5M PHARMACEUTICALS ADMINISTRA AMPOULE
ICALS LTD ALS (U) LIMITED BROMIDE+SA G/2.5ML LIMITED-KALIAKOIR TION LIQUID CARTON
LBUTAMOL GAZIPUR – 1750, FOR
SULPHATE BANGLADESH INHALATION
2817 NDA/MAL/H SQUARE GAMA MEXLO LOMEFLOXAC 0.3%W/V SQUARE BANGLADESH OPHTHALMI 1.0X5.0 7/1/2017
DP/6109 PHARMACEUT PHARMACEUTIC IN PHARMACEUTICALS LTD - C DROPS ML
ICALS LTD ALS (U) LIMITED HYDROCHLOR DHAKA UNIT KALIAKOIR BOTTLE
IDE GAZIPUR
2818 NDA/MAL/H SQUARE GAMA MOTIFAST DOMPERIDO 10MG SQUARE BANGLADESH ORAL SOLID 1.0X10.0X 7/1/2017
DP/6111 PHARMACEUT PHARMACEUTIC NE PHARMACEUTICALS LTD - ORDINARY 10.0
ICALS LTD ALS (U) LIMITED DHAKA UNIT KALIAKOIR OTHER TABLET
GAZIPUR TABLETS BLISTER,1.
0X3.0X10.
0 TABLET
BLISTER
2819 NDA/MAL/H FDC LTD AIVEEN (U) ZOXAN CIPROFLOXAC 0.3% W/V FDC LIMITED -B-8, INDIA OPHTHALMI 1.0X1.0X5 7/1/2005
DP/6114 LIMITED IN M.I.D.C., INDUSTRIAL C DROPS .0 ML
AREA, WALUJ – BOTTLE
AURANGABAD- 431 136
MAHARASHTRA, INDIA.
2820 NDA/MAL/H WEST-COAST SUPER MEDIC TIZOLE TINIDAZOLE 500MG WEST COAST INDIA ORAL SOLID 1.0X4.0 7/1/1997
DP/6115 PHARMACEUT LTD-MBARARA PHARMACEUTICAL WORKS ORDINARY TABLET
ICAL WORKS LTD-1143,MELDI TABLETS STRIP
LTD ESTATE,NR PRASANG
PARTY PLOT,GOTA,
AHMEDEBAD
2821 NDA/MAL/H DENK BENLE CONSULT ZOLEDRO- ZOLEDRONIC 4MG/5ML HAMELN GERMANY PARENTERAL 1.0X5.0 7/1/2017
DP/6116 PHARMA LIMITED DENK ACID PHARMACEUTICALS GMBH- ORDINARY ML VIAL
GMBH & CO 4MG/5ML LANGES FELD 13 31789 INFUSION
KG HAMELN VIALS/BOTTL
ES
2822 NDA/MAL/H DENK BENLE CONSULT GRAN- GRANISETRO 1MG/ML SIEGFRIED HAMELN GMBH- GERMANY PARENTERAL 1.0X5.0 7/1/2017
DP/6117 PHARMA LIMITED DENK N LANGES FELD 13,31789 ORDINARY ML
GMBH & CO HYDROCHLOR HAMELN AMPOULES AMPOULE
KG IDE
2823 NDA/MAL/H LEBEN ANDYCO L-TRIM DS SULPHAMETH 800MG + LEBEN LABORATORIES INDIA ORAL SOLID 1.0X10.0X 7/1/2017
DP/6118 LABORATORIE PHARMACY OXAZOLE + 160MG PVT. LTD-PLOT NO. L-4, ORDINARY 10.0
S PVT LTD (UGANDA) LTD TRIMETHOPRI PHASE-III, MIDC, TABLETS TABLET
M AKOLA– 444 104 (MS). BLISTER
2824 NDA/MAL/H NATIONAL ANDYCO KMINE KETAMINE 50MG/ML NATIONAL HEALTHCARE NEPAL PARENTERAL 1.0X10.0 7/1/2017
DP/6120 HEALTHCARE PHARMACY HYDROCHLOR PVT LTD-CHHATAPIPRA 3 ORDINARY ML VIAL
PVT LTD (UGANDA) LTD IDE BARA NEPAL VIALS
2825 NDA/MAL/H İLKO İLAÇ CORE ACCESS DEXIREN DEXKETOPRO 25MG İLKO İLAÇ SANAYI VE TURKEY ORAL SOLID 1.0X2.0X1 7/1/2017
DP/6121 SANAYI VE LTD FEN TICARET A. Ş-3. ORGANIZE ORDINARY 0.0
TICARET A. Ş. TROMETAMO SANAYI BÖLGESI KUDDUSI FILM- TABLET
L CAD. 23. SOK. NO:1 COATED BLISTER
SELÇUKLU / KONYA TABLETS
2826 NDA/MAL/H TROIKAA ABACUS ROCUTROY ROCURONIU 10MG TROIKAA INDIA PARENTERAL 1.0X5.0 7/1/2017
DP/6122 PHARMACEUT PHARMA M BROMIDE PHARMACEUTICALS LTD- ORDINARY ML VIAL
ICALS LIMITED (AFRICA) SARA INDUSTRIAL ESTATE VIALS
248197 UTTARAKHAND
2827 NDA/MAL/H OCTOBER ABACUS MONOMAK ISOSORBIDE 20MG OCTOBER PHARMA-1ST EGYPT ORAL SOLID 1.0X2.0X1 7/1/2017
DP/6123 PHARMA PHARMA NITRATE INDUSTRIAL ZONE STREET ORDINARY 0.0
(AFRICA) 25 PLOT 190 6TH TABLETS TABLET
LIMITED OCTOBER CITY CAIRO BLISTER
2828 NDA/MAL/H MEDICAL KARURI DERMOTRA NEOMYCIN 165,000 IU MEDICAL UNION EGYPT TOPICAL 1.0X150.0 7/1/2016
DP/6126 UNION PHARMACEUTIC CIN SULPHATE + + 12,500 IU PHARMACEUTICALS-36 DR EXTERNAL ML
PHARMACEUT ALS LTD. BACITRACIN MOHAMED HASSAN EL- PRESSURISED CANNISTE
ICALS GAMAL ST.6TH DISTRICT AEROSOLS R
NASR CITY EGYPT
2829 NDA/MAL/H JANSSEN- MEDICAL INTELENCE ETRAVIRINE 25MG JANSSEN-CILAG S.P.A.-VIA ITALY ORAL SOLID 1.0X120.0 7/1/2016
DP/6127 CILAG ACCESS C. JANSSEN BORGO S. ORDINARY TABLET
INTERNATION (UGANDA) MICHELE 04100 LATINA TABLETS BOTTLE
AL NV LIMITED
2830 NDA/MAL/H GLAXOSMITH UNITED TRIUMEQ DOLUTEGRAV 50MG + GLAXO OPERATIONS UK UNITED ORAL SOLID 1.0X30.0 7/1/2016
DP/6129 KLINE HEALTHCARE IR + 600MG + LTD (TRADING AS GLAXO KINGDOM ORDINARY TABLET
PHARMACEUT DISTRIBUTORS ABACAVIR + 300MG WELLCOME OPERATIONS)- FILM- CONTAIN
ICAL KENYA LTD LAMIVUDINE PRIORY STREET, WARE COATED ER
LTD HERTFORDSHIRE SG12 TABLETS
0DJ, UK
2831 NDA/MAL/H HOVID BHD UNITED KETOVID KETOCONAZO 2%W/W HOVID BHD -121 ,JALAN MALAYSIA TOPICAL 1.0X120.0 7/1/2016
DP/6132 HEALTHCARE LE TUNKU ABDUL RAHMAN , EXTERNAL ML
DISTRIBUTORS 30010 IPOH , PERAK , LIQUID BOTTLE
LTD MALAYSIA SOAPS/WAS
HES
2832 NDA/MAL/H UMEDICA VITACARE RILIF-100 ACECLOFENA 100MG UMEDICA LABORATORIES INDIA ORAL SOLID 1.0X3.0X1 7/1/2016
DP/6133 LABORATORIE LIMITED C PVT, VAPI-PLOT 221, GIDC ORDINARY 0.0
S PVT LTD II, VAPI-396195, INDIA TABLETS TABLET
BLISTER
2833 NDA/MAL/H MACLEODS NORVIK ZAMADOL P TRAMADOL 37.5MG+3 MACLEODS INDIA ORAL SOLID 1.0X3.0X1 7/1/2016
DP/6134 PHARMACEUT ENTERPRISES HYDROCHLOR 25MG PHARMACEUTICALS ORDINARY 0.0
ICALS LTD LIMITED IDE+ACETAMI LIMITED -BLOCK-N2 TABLETS TABLET
NOPHEN VILLAGE THEDA POST BLISTER
OFFICE LODHIMAJRA
TEHSIL BADDI DISTRICT
SOLAN HIMACHAL
PRADESH – 174101
INDIA
2834 NDA/MAL/H ABACUS ABACUS TRIXONE-S CEFTRIAXONE 1000MG+5 REYOUNG CHINA PARENTERAL 1.0X20.0 7/1/2016
DP/6135 PHARMA (A) PHARMA SODIUM+SUL 00MG PHARMACEUTICAL CO. ORDINARY ML VIAL
LTD. (AFRICA) BACTAM LTD-NO. 6 ERLANGSHAN DRY VIALS
SHANDONG 256100
2835 NDA/MAL/H CADILA ABACUS NUCOXIA ETORICOXIB 120MG CADILA HEALTHCARE INDIA ORAL SOLID 1.0X3.0X1 7/1/2016
DP/6136 HEALTH CARE PHARMA 120 LIMITED -PLOT 203-213, ORDINARY 0.0
LIMITED (AFRICA) KUNDAIM INDUSTRIAL FILM- TABLET
LIMITED ESTATE, GOA COATED BLISTER
TABLETS
2836 NDA/MAL/H BHARAT ABACUS LUPRODEX LEUPROLIDE 3.75MG BHARAT SERUMS AND INDIA PARENTERAL 1.0X1.0 7/1/2016
DP/6137 SERUMS AND PHARMA ACETATE VACCINES LIMITED,-PLOT ORDINARY S ML VIAL +
VACCINES LTD (AFRICA) NO. K-27, ADDITIONAL C VIALS 1*2ML
LIMITED MIDC, GLASS
AMBERNATH (EAST), AMPOULE
INDIA OF
DILUENT
(EACH ML
CONTAINS
50MG OF
D-
MANNITO
2837 NDA/MAL/H CADILA ABACUS NUCOXIA ETORICOXIB 60MG CADILA HEALTH CARE INDIA ORAL SOLID 1.0X3.0X1 7/1/2016
DP/6138 HEALTHCARE PHARMA 60 LIMITED -PLOT 203-213, ORDINARY 0.0
LTD (AFRICA) KUNDAIM INDUSTRIAL FILM- TABLET
LIMITED ESTATE, GOA COATED BLISTER
TABLETS
2838 NDA/MAL/H SQUARE GAMA SERVIN FERROUS 150MG+0. SQUARE BANGLADESH ORAL SOLID 1.0X10.0X 7/1/2016
DP/6139 PHARMACEUT PHARMACEUTIC CAPSULE SULPHATE+F 5MG+2MG PHARMACEUTICALS LTD - ORDINARY 10.0
ICALS LTD ALS (U) LIMITED OLIC +2MG+1M DHAKA UNIT KALIAKOIR CAPSULES CAPSULE
ACID+THIAMI G+10MG+5 GAZIPUR BLISTER,1.
NE 0MG 0X3.0X10.
MONONITRA 0
TE+RIBOFLAV CAPSULE
IN+PYRIDOXI BLISTER
NE
HYDROCHLOR
IDE+NICOTIN
AMIDE+ASCO
2839 NDA/MAL/H UNOSOURCE ESCORTS ACEWEL ACECLOFENA 100MG AKUMS DRUGS & INDIA ORAL SOLID 1.0X10.0 7/1/2016
DP/6141 PHARMA LTD PHARMACEUTIC C PHARMACEUTICALS LTD- ORDINARY TABLET
ALS LIMITED 19, 20,21 SECTOR 6A IIE FILM- BLISTER,1.
SIDCUL RANIPUR COATED 0X10.0X10
HARIDWAR 249 403 TABLETS .0 TABLET
BLISTER
2840 NDA/MAL/H GITTOES GITTOES AGOCARB ACTIVATED 0.25MG AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1.0X100.0 7/1/2016
DP/6142 PHARMACEUT PHARMACEUTIC CHARCOAL NO.33,SECTOR ORDINARY TABLET
ICALS LIMITED ALS LIMITED II,VASAI,TALUKA INDL CO- TABLETS BOTTLE,1.
OP ESTATE LTD,GAURAI 0X10.0X10
PADA,VASAI(E)DIST.THAN .0 TABLET
E INDIA BLISTER
2841 NDA/MAL/H MARCYRL SHREEJI CONTRACT EXTRACT 10G+5000 MARCYRL EGYPT TOPICAL 1.0X20.0 7/1/2016
DP/6143 PHARMACEUT PHARMACEUTIC UBEX CEPAE FLUID I.U+1G/10 PHARMACEUTICAL EXTERNAL G TUBE
ICAL ALS LIMITED +HEPARIN 0G INDUSTRIES.-EL OBOUR GELS AND
INDUSTRIES SODIUM+ALL CITY CAIRO SOLS
ANTOIN
2842 NDA/MAL/H NATIONAL ANDYCO NIKO PARACETAM 500MG NATIONAL HEALTHCARE NEPAL ORAL SOLID 1.0X10.0X 7/1/2016
DP/6144 HEALTHCARE PHARMACY OL PVT LTD-CHHATAPIPRA 3 ORDINARY 100.0
(UGANDA) LTD BARA TABLETS TABLET
BLISTER,1.
0X10.0X10
.0 TABLET
BLISTER
2843 NDA/MAL/H MYLAN KIMSY MEDS ENDULIN INSULIN 100I.U/ML BIOCON LIMITED-SPECIAL INDIA PARENTERAL 1.0X3.0 7/1/2016
DP/6145 PHARMACEUT LTD SELECT GLARGINE(R- ECONOMIC ZONE, ORDINARY ML
ICAL PRIVATE DNA ORGIN) PLOT NO.2-4, PHASE IV, PRE-FILLED PREFILLED
LIMITED, BOMMASANDRA- JIGANI PENS PEN
INDIA LINK ROAD BANGALORE-
560 099 INDIA
2844 NDA/MAL/H MYLAN KIMSY MEDS ENDULIN INSULIN 100I.U/ML BIOCON LIMITED-SPECIAL INDIA PARENTERAL 1.0X10.0 7/1/2016
DP/6147 PHARMACEUT LTD VAIL GLARGINE (R- ECONOMIC ZONE, ORDINARY S ML VIAL
ICAL PRIVATE DNA ORIGIN) PLOT NO.2-4, PHASE IV, C VIALS
LIMITED, BOMMASANDRA- JIGANI
INDIA LINK ROAD BANGALORE-
560 099 INDIA
2845 NDA/MAL/H AMANTA PHARMA VILLE SODIUM SODIUM 0.9%W/V MARCK BIOSCIENCES INDIA PARENTERAL 1.0X500.0 7/1/2016
DP/6149 HEALTHCARE LIMITED CHLORIDE CHLORIDE LIMITED. .-PLOT 876, NH ORDINARY ML
LTD INFUSION NO. 8, HARIYALA, KHEDA- INFUSION BOTTLE
ES
2846 NDA/MAL/H NITIN HEALTHCARE NITCAINE LIDOCAINE 2%W/V NITIN LIFESCIENCES LTD..- INDIA PARENTERAL 1.0X10.0X 7/1/2016
DP/6151 LIFESCIENCES LTD. RAMPUR GHAT ROAD, ORDINARY 30.0 ML
LTD PAOMTA SAHIB DIST. VIALS VIAL
SIRMOUR H.
2847 NDA/MAL/H SANDOZ SURGIPHARM CARVEDILO CARVEDILOL 12.5MG SALUTAS PHARMA GMBH- GERMANY ORAL SOLID 1.0X3.0X1 7/1/2016
DP/6152 KENYA C/O (U) LIMITED L SANDOZ OTTO-VON-GUERICKE- ORDINARY 0.0
NOVARTIS 12.5MG ALLEE TABLETS TABLET
PHARMA BLISTER
SERVICES INC
2848 NDA/MAL/H SANDOZ SURGIPHARM CARVEDILO CARVEDILOL 25MG SALUTAS PHARMA GMBH- GERMANY ORAL SOLID 1.0X3.0X1 7/1/2016
NOVARTIS 25MG ALLEE TABLETS TABLET
PHARMA BLISTER
SERVICES INC
2849 NDA/MAL/H SANDOZ SURGIPHARM CARVEDILO CARVEDILOL 6.25MG SALUTAS PHARMA GMBH- GERMANY ORAL SOLID 1.0X3.0X1 7/1/2016
NOVARTIS ALLEE TABLETS TABLET
PHARMA BLISTER
SERVICES INC
2850 NDA/MAL/H DEVA SHREEJI DESEFIN CEFTRIAXONE 1G DEVA HOLDING A.S- TURKEY PARENTERAL 1.0X1.0 G 7/1/2016
DP/6158 HOLDING A.S PHARMACEUTIC SODIUM CERKEZKOY ORGANIZE ORDINARY VIAL
ALS LIMITED SANAYI BOLGESI, DRY VIALS
KARAAGAC MAH.,
KAPAKLI TEKIRDAG
2851 NDA/MAL/H NORVATIS SURGIPHARM AMLODIPIN AMLODIPINE 10MG LEK PHARMACEUTICALS SLOVENIA ORAL SOLID 1.0X3.0X1 7/1/2016
DP/6159 ACCESS (U) LIMITED E .D.D -VEROVSKOVA 57, ORDINARY 0.0
1526 LJUBLJANA TABLETS TABLET
SLOVENIA BLISTER,1.
0X10.0X10
.0 TABLET
BLISTER
2852 NDA/MAL/H SANDOZ SURGIPHARM DICLAC DICLOFENAC 150MG SALUTAS PHARMA GMBH- GERMANY ORAL SOLID 1.0X10.0 7/1/2016
DP/6161 KENYA C/O (U) LIMITED SODIUM OTTO-VON-GUERICKE- ORDINARY TABLET
NOVARTIS ALLEE TABLETS BLISTER
PHARMA
SERVICES INC
2853 NDA/MAL/H SANDOZ SURGIPHARM NEXMEZOL ESOMEPRAZO 40MG SALUTAS PHARMA GMBH- GERMANY ORAL SOLID 1.0X14.0 7/1/2016
DP/6164 GMBH C/O (U) LIMITED E LE OTTO-VON-GUERICKE- ORDINARY TABLET
NOVARTIS ALLEE TABLETS BOTTLE
PHARMA
SERVICES.
2854 NDA/MAL/H UNOSOURCE ESCORTS CEFTRISON CEFTRIAXONE 1G/VIAL AKUMS DRUGS & INDIA PARENTERAL 1.0X1.0 G 7/1/2016
DP/6165 PHARMA LTD. PHARMACEUTIC E - 1000 SODIUM PHARMACEUTICALS LTD. - ORDINARY VIAL
ALS LIMITED PLANT III,-PLOT NO. 2, 3, 4 DRY VIALS
& 5, SECTOR 6-B, IIE,
2855 NDA/MAL/H NATIONAL ANDYCO GMICIN GENTAMICIN 0.3%W/V NATIONAL HEALTHCARE NEPAL OPHTHALMI 1.0X10.0 7/1/2016
DP/6166 HEALTHCARE PHARMACY SULPHATE PVT LTD-CHHATAPIPRA 3 C DROPS ML
(UGANDA) LTD BARA BOTTLE
2856 NDA/MAL/H UNOSOURCE ABACUS AKUROSE IRON 20MG/ML AKUMS DRUGS & INDIA PARENTERAL 1.0X5.0X5 1/7/2016
DP/6167 PHARMA LTD. PHARMA SUCROSE PHARMACEUTICALS LTD. - ORDINARY .0 ML
(AFRICA) PLANT III,-PLOT NO. 2, 3, 4 INFUSION AMPOULE
LIMITED & 5, SECTOR 6-B, IIE, AMPOULES
2857 NDA/MAL/H JANSSEN- MEDICAL INTELENCE ETRAVIRINE 100MG JANSSEN-CILAG S.P.A.-VIA ITALY ORAL SOLID 1.0X120.0 7/1/2016
DP/6169 CILAG ACCESS C. JANSSEN BORGO S. ORDINARY TABLET
INTERNATION (UGANDA) MICHELE 04100 LATINA TABLETS BOTTLE
AL NV LIMITED
2858 NDA/MAL/H SQUARE GAMA ALACOT OLOPATADIN 0.1%W/V SQUARE BANGLADESH OPHTHALMI 1.0X5.0 1/7/2016
DP/6170 PHARMACEUT PHARMACEUTIC 0.1% EYE E PHARMACEUTICALS LTD- C DROPS ML
ICALS LTD ALS (U) LIMITED DROPS HYDROCHLOR KALIAKOIR BOTTLE
IDE
2859 NDA/MAL/H CIPLA LTD.. QUALITY MONTAIR 5 MONTELUKAS 5MG CIPLA LTD ----L139 TO L- INDIA ORAL SOLID 1.0X10.0 7/1/2016
DP/6173 CHEMICALS LTD - T SODIUM 146 VERNA INDUSTRIAL ORDINARY TABLET
HUMAN ESTATE VERNA SALCETTE CHEWABLE BLISTER
GOA 403 722 TABLETS
2860 NDA/MAL/H DENK BENLE CONSULT ON.SETRON- ONDANSENT 4MG DENK PHARMA GMBH & GERMANY ORAL SOLID 1.0X6.0 7/1/2016
DP/6179 PHARMA LIMITED DENK 4MG RON CO. KG -GOLLSTR. 1 84529 ORDINARY TABLET
GMBH & CO ODT TITTMONING SOLUBLE BLISTER
KG TABLETS
2861 NDA/MAL/H SIGMA-TAU LABOREX EURARTESI PIPERAQUINE 320MG+40 SIGMA-TAU INDUSTRIE ITALY ORAL SOLID 1.0X9.0 7/1/2016
DP/6180 INDUSTRIE UGANDA M TETRAPHOSP MG FARMACEUTICHE RIUNITE ORDINARY TABLET
FARMACEUTI LIMITED HATE + S.P.A -VIALE SHAKESPEARE TABLETS BLISTER,1.
CHE RIUNITE DIHYDROART 47-00144 ROME ITALY 0X3.0
S.P.A. EMISININ TABLET
BLISTER,1.
0X6.0
TABLET
BLISTER,1.
0X12.0
TABLET
BLISTER
2862 NDA/MAL/H UNOSOURCE ABACUS AZINOWEL- AZITHROMYCI 500MG AKUMS DRUGS AND INDIA ORAL SOLID 1.0X3.0 7/1/2016
DP/6181 PHARMA LTD. PHARMA 500 N PHARMACEUTICALS LTD- ORDINARY TABLET
(AFRICA) PLANT-1 PLOT NO.19, FILM- BLISTER
LIMITED 20&21 SECTOR-6A, 11E, COATED
SIDCUL, RAHIPUR DISTT; TABLETS
HARIDWAR, 249403,
(UTTRAKHAND) INDIA
2863 NDA/MAL/H SQUARE GAMA ALARID KETOTIFEN 0.025%W/ SQUARE BANGLADESH OPHTHALMI 1.0X5.0 7/1/2016
DP/6182 PHARMACEUT PHARMACEUTIC FUMARATE V PHARMACEUTICALS LTD - C DROPS ML
ICALS LTD ALS (U) LIMITED DHAKA UNIT KALIAKOIR BOTTLE
GAZIPUR
2864 NDA/MAL/H CIPLA LTD.. QUALITY PRAZIQUA PRAZIQUANT 600MG CIPLA LTD .-352 KUNDAIM INDIA ORAL SOLID 1.0X100.0 7/1/2016
DP/6183 CHEMICALS LTD - NTEL EL INDL. ESTATE KUNDAIM ORDINARY TABLET
HUMAN TABLETS GOA 403 115 FILM- BOTTLE,1.
COATED 0X500.0
TABLETS TABLET
BOTTLE
2865 NDA/MAL/H UNITED WIDE ATOXIA ETORICOXIB 60MG UNITED JORDAN ORAL SOLID 1.0X10.0 7/1/2016
DP/6184 PHARMACEUT SPECTRUM 60MG PHARMACEUTICAL ORDINARY TABLET
ICAL ENTERPRISES MANUFACTURING FILM- BLISTER
MANUFACTU (U) LIMITED COMPANY LTD-P.O BOX COATED
SECURITY HOUSING
2866 NDA/MAL/H DENK BENLE CONSULT DOLOFORT TRAMADOL 37.5MG + DENK PHARMA GMBH & GERMANY ORAL SOLID 1.0X2.0X1 7/1/2016
DP/6185 PHARMA LIMITED E DENK HYDROCHLOR 325MG CO. KG -GOLLSTR. 1 84529 ORDINARY 0.0
GMBH & CO IDE + TITTMONING FILM- TABLET
KG PARACETAM COATED BLISTER
OL TABLETS
2867 NDA/MAL/H UNITED WIDE ATOXIA ETORICOXIB 90MG UNITED JORDAN ORAL SOLID 1.0X10.0 7/1/2016
DP/6186 PHARMACEUT SPECTRUM 90MG F.C. PHARMACEUTICAL ORDINARY TABLET
ICAL ENTERPRISES TABLETS MANUFACTURING FILM- BLISTER
MANUFACTU (U) LIMITED COMPANY LTD-P.O BOX COATED
SECURITY HOUSING
2868 NDA/MAL/H DAR AL DAWA GAMA GIZLAN 150 IRBESARTAN 150MG DAR AI DAWA-NA UR JORDAN ORAL SOLID 1.0X3.0X1 7/1/2016
CO LTD TABLETS
2869 NDA/MAL/H GITTOES GITTOES D-LYTE ANHYDROUS 2.7MG+0.5 AGOG PHARMA LTD-PLOT INDIA ORAL LIQUID 1.0X500.0 7/1/2015
DP/6190 PHARMACEUT PHARMACEUTIC GLUCOSE+SO 2MG+0.58 NO.33,SECTOR ORDINARY ML
ICALS LIMITED ALS LIMITED DIUM MG+0.30M II,VASAI,TALUKA INDL CO- SOLUBLE SACHET,1.
CHLORIDE+TR G PER OP ESTATE LTD,GAURAI POWDERS 0X1000.0
ISODIUM 200ML PADA,VASAI(E)DIST.THAN ML
CITRATE+POT SACHET,6. E INDIA SACHET,1.
ASSIUM 75MG+1.3 0X200.0
CHLORIDE,AN 0MG+1.45 ML
HYDROUS MG+0.75M SACHET
GLUCOSE+SO G PER
DIUM 500ML
CHLORIDE+TR SACHET,13
2870 NDA/MAL/H AMOUN WIDE KAPRON TRANEXAMIC 500MG/5 AMOUN EGYPT PARENTERAL 1.0X6.0X5 7/1/2016
DP/6191 PHARMACEUT SPECTRUM AMPOULE ACID ML PHARMACEUTICAL CO. ORDINARY .0 ML
ICALS ENTERPRISES S.A.E-1ST INDUSTRIAL AMPOULES AMPOULE
COMPANY (U) LIMITED ZONE A, PLOTS NO.
1B,2,3,4,5 BLOCK 13015,
EL-OBOUR CITY,
KALYOUBIA CAIRO
EGYPT
2871 NDA/MAL/H SPARSH BIO- ABACUS AMOXICILLI AMOXICILLIN 250MG + SPARSH BIO-TECH PVT. INDIA ORAL SOLID 1.0X10.0 7/1/2016
DP/6201 TECH PVT. PHARMA N AND TRIHYDRATE 250MG LIMITED-PLOT NO. ORDINARY CAPSULE
LTD (AFRICA) FLUCLOXAC + 1;SURVEY NO. CAPSULES STRIP
LIMITED ILLIN FLUCLOXACIL 242/243/244,LAKHABAVA
CAPSULES LIN SODIUM D,JAMNAGAR-361 006,
500MG INDIA.
2872 NDA/MAL/H HOVID BHD UNITED DEROX-5 AMLODIPINE 5MG HOVID BHD -121 ,JALAN MALAYSIA ORAL SOLID 1.0X3.0X1 7/1/2016
DP/6203 HEALTHCARE BESILATE TUNKU ABDUL RAHMAN , ORDINARY 0.0
LTD MALAYSIA BLISTER,1.
0X10.0X10
.0 TABLET
BLISTER
2873 NDA/MAL/H AMANTA PHARMA VILLE GLUCOSE GLUCOSE 5%W/V MARCK BIOSCIENCES INDIA PARENTERAL 1.0X500.0 7/1/2016
DP/6204 HEALTHCARE LIMITED 5% I.V LIMITED. .-PLOT 876, NH ORDINARY ML
LTD NO. 8, HARIYALA, KHEDA- INFUSION BOTTLE
ES
2874 NDA/MAL/H MYLAN KIMSY MEDS ACICLOVIR ACICLOVIR 400MG MYLAN LABORATORIES INDIA ORAL SOLID 1.0X10.0 7/1/2016
DP/6205 LABORATORIE LTD LIMITED.-PLOT NO. H-12 & ORDINARY TABLET
S LIMITED H-13 TABLETS BLISTER
AREA,
MAHARASHTRA STATE,
INDIA.
2875 NDA/MAL/H S K AGE ABACUS GO!GEL DICLOFENAC 1.16%W/W S KANT HEALTHCARE LTD- INDIA TOPICAL 1.0X30.0 7/1/2013
DP/6207 EXPORTS PHARMA DIETHYLAMIN + 10%W/W PLOT NO. 1802-1805, EXTERNAL G TUBE
(AFRICA) E+METHYL G.I.D.C. PHASE III, VAPI GELS AND
LIMITED SALICYLATE 396 195. GUJARAT. SOLS
2876 NDA/MAL/H EXPHAR SA SURGIPHARM CLOFAINS PARACETAM 500MG/50 MILAN LABORATORIES INDIA ORAL SOLID 1.0X10.0 7/1/2016
DP/6211 (U) LIMITED OL/DICLOFEN MG (INDIA ) PVT LTD-PLOT ORDINARY TABLET
AC SODIUM NO.63-67 & 87,JAWAHAR TABLETS BLISTER
CO.OP.INDUSTRIAL
ESTATE LTD
KAMOTHE,PANVEL DIST.
THANE,MAHARASTRA-
410209,INDIA
2877 NDA/MAL/H NOVARTIS SURGIPHARM NEORAL 25 CYCLOSPORIN 25MG R P SCHERER GMBH & CO. GERMANY ORAL SOLID 1.0X5.0X1 7/1/2016
DP/6215 PHARMA (U) LIMITED EBERBACH BALEN-R P ORDINARY 0.0
SERVICES INC SCHERER GMBH & CO. OTHER CAPSULE
EBERBACH BALEN CAPSULES BLISTER
2878 NDA/MAL/H NOVARTIS SURGIPHARM NEORAL CYCLOSPORIN 100MG R P SCHERER GMBH & CO. GERMANY ORAL SOLID 1.0X5.0X1 7/1/2016
DP/6216 PHARMA (U) LIMITED 100 EBERBACH BALEN-R P ORDINARY 0.0
SERVICES INC SCHERER GMBH & CO. OTHER CAPSULE
EBERBACH BALEN CAPSULES BLISTER
2879 NDA/MAL/H INDIAN TATA UGANDA ELOVAC -B HEPATITIS B 20MCG/ML HUMAN BIOLOGICALS INDIA PARENTERAL 1.0X10.0X 7/1/2016
DP/6217 IMMUNOLOGI LIMITED (RDNA) INSTITUTE (A DIVISION OF ORDINARY 1.0 ML
CALS LTD INDIAN VIALS VIAL (1
IMMUNOLOGICALS LTD)- DOSE
RAKSHAPURAM VIAL)
GACHIBOWLI POST
HYDERABAD 500032
2880 NDA/MAL/H ASTRA MACNAUGHTON FORXIGA DAPAGLIFLOZ 10MG BRISTOL-4601 HIGHWAY UNITED ORAL SOLID 1.0X2.0X1 7/1/2016
DP/6218 ZENECA LIMITED IN 62 EAST MOUNT VERNON STATES ORDINARY 4.0
INDIANA 47620 TABLETS TABLET
USA BLISTER
2881 NDA/MAL/H SHOSAAN RENE METHYLDO METHYLDOPA 250MG NEM LABORATORIES PVT INDIA ORAL SOLID 1.0X10.0X 7/1/2016
DP/6220 ASIC PACIFIC PHARMACY LTD PA LTD-133 KRISHNA ORDINARY 10.0
INDUSTRIAL ESTATE VASAI FILM- TABLET
(E) DIST THANE 401 210 COATED BLISTER
MAHARASHTRA TABLETS
2882 NDA/MAL/H AUROLAB SWASTIK AUROPROS LATANOPROS 0.005%W/ AUROLAB.-SIVAGANGAI INDIA OPHTHALMI 1.0X2.5 7/1/2016
DP/6223 PHARMACEUTIC T- RT T V MAIN ROAD, C DROPS ML
AL LTD VEERAPANJAN, MADURAI BOTTLE
625 020 TAMIL INDIA
2883 NDA/MAL/H NITIN HEALTHCARE NICLOFEN DICLOFENAC 75MG/3ML NITIN LIFESCIENCES LTD-- INDIA PARENTERAL 1.0X10.0X 7/1/2016
DP/6224 LIFESCIENCES LTD. SODIUM RAMPUR ROAD PAONTA ORDINARY I 5.0X2.0
LTD SAHIB DIST. SIRMOUR M ML
(H.P) 173 025 AMPOULES AMPOULE
2884 NDA/MAL/H SPARSH BIO- ABACUS CO- FLUCLOXACIL 250MG SPARSH BIO-TECH PVT. INDIA ORAL SOLID 1.0X10.0 7/1/2016
DP/6229 TECH PVT LTD PHARMA FLUAMPICIL LIN SODIUM + +250MG LIMITED-PLOT NO. ORDINARY CAPSULE
(AFRICA) CAPSULES AMPICILLIN 1;SURVEY NO. CAPSULES STRIP
LIMITED BP 500MG TRIHYDRATE 242/243/244,LAKHABAVA
D,JAMNAGAR-361 006,
INDIA.
2885 NDA/MAL/H CACHET ASTRA PHARMA EMITINO ONDANSENT 4MG CACHET INDIA ORAL SOLID 1.0X10.0 7/1/2016
DP/6230 PHAMACUITIC (U) LIMITED RON PHARMACEUTICALS PVT ORDINARY TABLET
ALS PVT LTD LTD -THANA BADDI ORALLY BLISTER
173205 DISTRICT SOLAN DISINTEGRA
(HIMACHAL PRADESH) TING
INDIA TABLETS
2886 NDA/MAL/H GUILIN STAR D-ARTEPP DIHYDROART 20MG/160 GUILIN PHARMACEUTICAL CHINA ORAL SOLID 1.0X2.0X3 7/1/2016
DP/6231 PHARMACEUT PHARMACEUTIC DISPERSIBL EMISININ/PIP MG CO LTD-NO.43 QILIDIAN ORDINARY .0 TABLET
ICALS CO.LTD ALS LTD E ERAQUINE ROAD GUILIN 541004 SOLUBLE BLISTER
GUANGXI TABLETS
2887 NDA/MAL/H FREDUN PLANET H-CURE LANSOPRAZO 30MG + FREDUN INDIA ORAL SOLID 1.0X7.0X6 7/1/2016
DP/6232 PHARMACEUT PHARMACEUTIC LE + 250MG + PHARMACEUTICALS LTD- ORDINARY .0 TABLET
ICALS LTD ALS UGANDA CLARITHROM 500MG VEOOR PALGHAR ( E ) 401 TABLETS BLISTER
LTD YCIN + 404 (BLISTER
TINIDAZOLE CONTAINS
2CAPSULE
S OF
LANSOPR
AZOLE + 2
TABLETS
OF
CLARITHR
DP/6234 PHARMACEUT PHARMACEUTIC EMESININE/ MG CO.,LTD-NO 43 QILIDIAN ORDINARY .0 TABLET
ICALS CO.LTD ALS LTD PIPERAQUINE ROAD GUILIN 541002, OTHER BLISTER
PHOSPHATE GUANGXI TABLETS
2889 NDA/MAL/H UNITED WIDE ANGINET VALSARTAN 160MG UNITED JORDAN ORAL SOLID 1.0X3.0X1 7/1/2016
DP/6235 PHARMACEUT SPECTRUM 160MG PHARMACEUTICAL ORDINARY 0.0
SECURITY HOUSING
2890 NDA/MAL/H MOONLINK PLANET FREMOL PARACETAM 325 MG + FREDUN INDIA ORAL SOLID 1.0X40.0X 7/1/2016
DP/6236 PHARMACEUT PHARMACEUTIC ADVANCE OL + 400 MG + PHARMACEUTICALS LTD- ORDINARY 2.0X10.0
ICALS LTD ALS UGANDA IBUPROFEN + 40 MG VEOOR PALGHAR ( E ) 401 CAPSULES CAPSULE
LTD CAFFEINE 404 BLISTER
2891 NDA/MAL/H HETERO LABS AIVEEN (U) LOPINAVIR/ LOPINAVIR/ 100MG/25 HETERO LABS LTD-22-110 INDIA ORAL SOLID 1.0X120.0 7/1/2016
DP/6237 LTD LIMITED RITONAVIR RITONAVIR MG IDA JEEDIMETLA ORDINARY TABLET
HYDERABAD 500-055 FILM- BOTTLE
ANDHRA PRADESH COATED
TABLETS
2892 NDA/MAL/H MICRO LABS PHILLIPS NEBILONG - NEBIVOLOL 5MG + MICRO LABS LTD 92 INDIA ORAL SOLID 1.0X3.0X1 7/1/2016
DP/6238 LIMITED PHARMACEUTIC AM HYDROCHLOR 5MG SIPCOT -92 SIPCOT ORDINARY 0.0
ALS (UGANDA) IDE + HOSUR 635 126 TAMIL LAYERED TABLET
LIMITED AMLODIPINE NADU TABLETS BLISTER
BESILATE
2893 NDA/MAL/H SANDOZ SURGIPHARM CLOPIDOGR CLOPIDOGREL 75MG SANDOZ PVT LTD- PLOT INDIA ORAL SOLID 1.0X2.0X7 7/1/2016
DP/6241 GMBH C/O (U) LIMITED EL NO. 8-A/2 & 8-B TTC ORDINARY .0 TABLET
NOVARTIS NORVATIS INDUSTRIAL AREA LARWE FILM- BLISTER
PHARMA ACCESS BLOCK VILLAGE DIGHE COATED
SERVICES. NAVI MUMBAI 400 708 TABLETS
MAHARASHTRA STATE
DP/6242 PHARMACEUT PHARMACEUTIC EMESININ/PI MG CO LTD-NO.43 QILIDIAN ORDINARY .0 TABLET
ICALS CO.LTD ALS LTD PERAQUINE ROAD GUILIN 541004 FILM- BLISTER
PHOSPHATE GUANGXI COATED
TABLETS
2895 NDA/MAL/H ABBVIE (PTY) UNITED SURVANTA BERACTANT 100MG/4 ABBVIE NORTH CHICAGO UNITED TOPICAL 1.0X4.0 7/1/2016
DP/6243 LTD HEALTHCARE ML FACILITY-1401 SHERDAN STATES EXTERNAL ML
DISTRIBUTORS ROAD NORTH CHICAGO INSTILLATIO VIAL,1.0X
LTD FACILITY ILLINOIS 60064 - N VIALS 8.0 ML
4000 VIAL
2896 NDA/MAL/H CACHET ASTRA PHARMA CABALIN PREGABALIN 75MG CACHET INDIA ORAL SOLID 1.0X2.0X1 7/1/2016
DP/6244 PHAMACUITIC (U) LIMITED PHARMACEUTICALS PVT ORDINARY 2.0
ALS PVT LTD LTD-VILLAGE AND POST CAPSULES CAPSULE
THANA BADDI TEHSIL BLISTER
NALAGARH SOLAN
DISTRICT HIMACHAL
PRADESH 173 205
2897 NDA/MAL/H BIOLOGICAL ABACUS COSCOPIN NOSCAPINE + 7MG+2 BIOLOGICAL E. LTD -PLOT INDIA ORAL LIQUID 1.0X100.0 7/1/2016
DP/6245 E. LTD PHARMA LINCTUS CHLORPHENI MG+ 3.25 NO.31 & 32 PHARMA CITY ORDINARY ML
(AFRICA) RAMINE MG+28 SELAQUI INDUSTRIAL SYRUPS BOTTLE
LIMITED MALEATE + MG/5 ML. AREA SELAQUI DEHRADUN-
SODIUM 248 197
CITRATE + UTTARAKHAND,INDIA
AMMONIUM
CHLORIDE
2898 NDA/MAL/H CIRON DRUGS RENE LUTHER ARTEMETHER 80MG/ML CIRON DRUGS AND INDIA PARENTERAL 1.0X6.0X1 7/1/2016
DP/6246 & PHARMACY LTD PHARMACEUTICALS PVT. ORDINARY I .0 ML
PHARMACEUT LTD-N-118, N119, N113, M AMPOULE
ICALS PVT LTD MIDC, TARAPUR, BOISAR, AMPOULES
DIST. THANE 401506,
INDIA
2899 NDA/MAL/H MILAN GITTOES MILOXY AMOXICILLIN 250MG MILAN LABORATORIES INDIA ORAL SOLID 1.0X10.0X 7/1/2016
DP/6247 LABORATORIE PHARMACEUTIC 250-DT TRIHYDRATE (INDIA ) PVT LTD-PLOT NO ORDINARY 10.0
S LTD (INDIA) ALS LIMITED 63/67/87 J.C.I.E LTD OTHER TABLET
PVT LTD KAMOTHE PANVER, NAVI TABLETS BLISTER
MUMBAI,INDIA
2900 NDA/MAL/H NITIN HEALTHCARE ARTEMETH ARTEMETHER 80MG/ML NITIN LIFESCIENCES LTD..- INDIA PARENTERAL 1.0X6.0X1 7/1/2016
DP/6248 LIFESCIENCES LTD. ER RAMPUR GHAT ROAD, ORDINARY .0 ML
LTD PAOMTA SAHIB DIST. AMPOULES AMPOULE
SIRMOUR H.
2901 NDA/MAL/H KOTRA ABACUS AXCEL METRONIDAZ 200MG KOTRA PHARMA (M) SDN. MALAYSIA ORAL SOLID 1.0X10.0X 7/1/2016
DP/6249 PHARMA (M) PHARMA METRONID OLE BHD-1 JALAN TTC 12, ORDINARY 10.0
SDN,BHD (AFRICA) AZOLE -200 CHENG INDUSTRIAL TABLETS TABLET
LIMITED TABLETS ESTATE, 75250 MELAKA BLISTER
MALYSIA
2902 NDA/MAL/H TORRENT KARURI TORGABALI PREGABALIN 75MG TORRENT INDIA ORAL SOLID 1.0X3.0X1 7/1/2016
DP/6251 PHARMACEUT PHARMACEUTIC N 75 PHARMACEUTICAL LTD- ORDINARY 0.0
ICALS LIMITED ALS LTD. AHMEDABAD-MEHSANA CAPSULES CAPSULE
AD-382721
2903 NDA/MAL/H TORRENT KARURI TORGABALI PREGABALIN 150MG TORRENT INDIA ORAL SOLID 1.0X3.0X1 7/1/2016
DP/6252 PHARMACEUT PHARMACEUTIC N 150 PHARMACEUTICAL LTD- ORDINARY 0.0
ICALS LIMITED ALS LTD. AHMEDABAD-MEHSANA CAPSULES CAPSULE
AD-382721
2904 NDA/MAL/H HOVID BHD UNITED AZIMAX- AZITHROMYCI 250MG HOVID BHD-LOT 56442, MALAYSIA ORAL SOLID 1.0X6.0X1 7/1/2016
DP/6256 HEALTHCARE 250 N DIHYDRATE 7.5 MILE JALAN ORDINARY 0.0
DISTRIBUTORS IPOH/CHEMO 31200 TABLETS TABLET
MALAYSIA
2905 NDA/MAL/H JANSSEN- MEDICAL EDURANT RILPIVIRINE 25MG JANSSEN CILAG S.P.A-VIA ITALY ORAL SOLID 1.0X30.0 7/1/2016
DP/6257 CILAG ACCESS C.JANSSEN, BORGO ORDINARY TABLET
INTERNATION (UGANDA) FILM- BOTTLE
AL NV LIMITED COATED
TABLETS
2906 NDA/MAL/H ACINO GOODMAN PARACONIC PARACETAM 10MG/ML S.M FARMACEUTICI SRL- ITALY PARENTERAL 1.0X100.0 7/1/2016
DP/6264 PHARMA AG INTERNATIONAL A 1000 MG OL ZONA INDUSTRIALE, ORDINARY I ML VIAL
LTD IV 85050 TITO-POTENZA V VIALS
(PZ) ITALY
2907 NDA/MAL/H DENK BENLE CONSULT TRAMADOL TRAMADOL 50MG LOSAN PHARMA GMBH- GERMANY ORAL SOLID 1.0X10.0 7/1/2016
DP/6267 PHARMA LIMITED DENK 50 HYDROCHLOR OTTO-HAHN-STR 13 79395 ORDINARY TABLET
GMBH & CO IDE NEUENBURG EFFERVESCE BOTTLE
KG NT TABLETS
2908 NDA/MAL/H MACLEODS NORVIK FEBUMAC FEBUXOSTAT 80MG MACLEODS INDIA ORAL SOLID 1.0X10.0 7/1/2017
DP/6270 PHARMACEUT ENTERPRISES 80 PHARMACEUTICALS LTD - - ORDINARY TABLET
ICALS LTD LIMITED VILLAGE THEDA P.O FILM- BLISTER,1.
LODHIMAJRA TEHSIL COATED 0X3.0X10.
BADDI DISTRICT SOLAN TABLETS 0 TABLET
HIMACHAL PRADESH BLISTER
INDIA 174101
2909 NDA/MAL/H SEV SEV BENZYL BENZYL 25%W/V SEV PHARMACEUTICALS UGANDA TOPICAL 1.0X100.0
DP/6275 PHARMACEUT PHARMACEUTIC BENZOATE BENZOATE LTD, -PLOT 100 MASAKA EXTERNAL ML
ICALS LIMITED ALS LIMITED APPLICATIO ROAD ,NALUKOLONGO EMULSIONS BOTTLE
N BP KAMPALA,UGANDA.
2910 NDA/MAL/H PSA ROYAL PHARMA CIFF-200 DT CEFIXIME 200MG ZIM LABORATORIES INDIA ORAL SOLID 1.0X1.0X1
DP/6279 INTERNATION 2011 LIMITED TRIHYDRATE LIMITED-B-21/22 MIDC ORDINARY 0.0
AL AREA KALMESHWAR SOLUBLE TABLET
441501, DIST NAGPUR, TABLETS STRIP
MAHARASHTRA
2911 NDA/MAL/H MICRO LABS PHILLIPS MEBUX-40 FEBUXOSTAT 40MG MICRO LABS LTD--NO 92, INDIA ORAL SOLID 1.0X3.0X1 11/7/2018
TABLETS
2912 NDA/MAL/H MICRO LABS PHILLIPS MEBUX-80 FEBUXOSTAT 80 MG MICRO LABS LTD--NO 92, INDIA ORAL SOLID 1.0X3.0X1 11/7/2018
TABLETS
2913 NDA/MAL/H CIPLA LTD QUALITY PAEDIATRIC PARACETAM 120MG/5 CIPLA LTD INDORE -PLOT INDIA ORAL LIQUID 1.0X100.0 11/7/2018
DP/6284 CHEMICALS LTD - PARACETA OL ML NO. 9 AND 10, INDORE ORDINARY ML
HUMAN MOL ORAL SPECIAL ECONOMIC ZONE, LIQUIDS BOTTLE
SOLUTION PHASE –II, PITHAMPUR,
DISTRICT DHAR, 454 775,
MADHYA PRADESH - INDIA
2914 NDA/MAL/H FRESENIUS SURGIPHARM SMOFKABIV MULTI- MULTI- FRESENIUS KABI AUSTRIA AUSTRIA PARENTERAL 1.0X493.0 11/7/2018
DP/6285 KABI SOUTH (U) LIMITED EN INGREDIENT INGREDIEN GMBH -- SWEDEN ORDINARY ML BAG
AFRICA (PTY) EMULSION T HAFNERSTRASSEM 36,A- INFUSION (1*[250M
LIMITED FOR 8055 GRAZ, AUSTRIA BAGS L AMINO
INFUSION FRESENIUS KABI AB- ACID
INTO A RAPSGATAN 7 SE-751 74 SOLUTION
CENTRAL UPPSALA SWEDEN WITH
VEIN ELECTROL
493ML - YTES +
550KCAL 149ML
GLUCOSE
42%
2915 NDA/MAL/H UNOSOURCE ESCORTS UNOPROG PROGESTERO 8.0% W/W AKUMS DRUGS & INDIA VAGINAL 1.0X1.0X1 12/17/2018
DP/6289 PHARMA LTD PHARMACEUTIC GEL NE PHARMACEUTICALS LTD .- GELS AND .0X1.125
ALS LIMITED 47, 48 SECTOR 6A I.I.E SOLS G
SIDCUL RANIPUR PREFILLED
HARIDWAR 249 403 PEN
2916 NDA/MAL/H MACLEODS NORVIK NEUROGAB PREGABALIN 150MG "MACLEODS INDIA ORAL SOLID 1.0X3.0X1 12/17/2018
DP/6293 PHARMACEUT ENTERPRISES 150 PHARMACEUTICALS LTD,-- ORDINARY 0.0
ICALS LTD LIMITED BLOCK N2, VILLAGE CAPSULES CAPSULE
THEDA, POST OFFICE BLISTER
LODHIMAJRA, TEHSIL
BADDI, DISTRICT SOLAN,
HIMACHAL PRADESH –
174101
INDIA."
2917 NDA/MAL/H NAPP SURGIPHARM FLUTIFORM FLUTICASONE 50MCG + FISONS LTD (TRADING AS UNITED LUNG 1.0X1.0X1 12/17/2018
DP/6296 PHARMACEUT (U) LIMITED PROPIONATE 5MCG / SANOFI)-72 LONDON KINGDOM ADMINISTRA 20.0
ICALS LIMITED + ACTUATIO ROAD, HOLMES CHAPEL TION METERED
FORMOTEROL N CREWE, CHESHIRE, CW4 BREATH- DOSE
FUMARATE 8BE, UNITED KINGDOM. ACTUATED CANNISTE
DIHYDRATE METERED- R
DOSE
INHALER
2918 NDA/MAL/H NAPP SURGIPHARM FLUTIFORM FLUTICASONE 250MCG + FISONS LTD (TRADING AS UNITED LUNG 1.0X1.0X1 12/20/2018
DP/6297 PHARMACEUT (U) LIMITED PROPIONATE 10MCG / SANOFI)-72 LONDON KINGDOM ADMINISTRA 20.0
ICALS LIMITED + ACTUATIO ROAD, HOLMES CHAPEL TION METERED
FORMOTEROL N CREWE, CHESHIRE, CW4 BREATH- DOSE
FUMARATE 8BE, UNITED KINGDOM. ACTUATED CANNISTE
DIHYDRATE METERED- R
DOSE
INHALER
2919 NDA/MAL/H GUILIN PHILLIPS AMOXICILLI AMOXICILLIN 250MG SINOPHARM WEIQIDA CHINA ORAL SOLID 1.0X1000. 1/31/2018
DP/6300 PHARMACEUT PHARMACEUTIC N PHARMACEUTICAL CO., ORDINARY 0
ICAL ALS (UGANDA) LTD-OSD WORKSHOP OF CAPSULES CAPSULE
(SHANGHAI) LIMITED ECONOMIC & CONTAIN
CO., LTD TECHNOLOGICAL ER,1.0X2.
DEVELOPMENT ZONE, 0X10.0
SECOND MEDICAL ZONE CAPSULE
DATONG, SHANXI, CHINA BLISTER
2920 NDA/MAL/H NAPP SURGIPHARM OXYNORM OXYCODONE 5MG BARD PHARMACEUTICALS UNITED ORAL SOLID 1.0X4.0X1 12/20/2018
DP/6303 PHARMACEUT (U) LIMITED 5MG HYDROCHLOR LIMITED-UNIT 191, KINGDOM ORDINARY 4.0
ICALS LIMITED IDE CAMBRIDGE SCIENCE OTHER CAPSULE
PARK, MILTON ROAD, CAPSULES BLISTER
CAMBRIDGE, CB4 0GW,
U.K
2921 NDA/MAL/H UNOSOURCE ABACUS UNOSURE LEVONORGES 1.5MG AKUMS DRUGS & INDIA ORAL SOLID 1.0X1.0 3/28/2019
DP/6304 PHARMA LTD PHARMA 72 TREL PHARMACEUTICALS LTD .- ORDINARY TABLET
(AFRICA) 47, 48 SECTOR 6A I.I.E FILM- BLISTER
LIMITED SIDCUL RANIPUR COATED
HARIDWAR 249 403 TABLETS
2922 NDA/MAL/H ZIM GITTOES ZIMCOX CELECOXIB 100MG ZIM LABORATORIES LTD-B- INDIA ORAL SOLID 1.0X3.0X1 9/26/2018
DP/6310 LABORATORIE PHARMACEUTIC 100 21/22, M.I.D.C. AREA, ORDINARY 0.0
S LTD ALS LIMITED KALMESHWAR – 441501, CAPSULES CAPSULE
DIST. NAGPUR, BLISTER
MAHARASHTRA,
CAMBRIDGE, CB4 0GW,
U.K
2924 NDA/MAL/H CIPLA LTD QUALITY DARUNAVI DARUNAVIR 800MG CIPLA LIMITED,-PLOT NO INDIA ORAL SOLID 1.0X1.0X3 11/7/2018
DP/6312 CHEMICALS LTD - R (AS ETHANOLATE A–42 (UNIT–II ) MIDC ORDINARY 0.0
HUMAN ETHANOLA PATALGANGA, FILM- TABLET
TE) DISTRICT RAIGAD, 410 220 COATED CONTAIN
TABLETS MAHARASHTRA,INDIA TABLETS ER
800 MG
CAMBRIDGE, CB4 0GW,
U.K
2926 NDA/MAL/H LEBEN ANDYCO PZQ PRAZIQUANT 600MG LEBEN LABORATORIES PVT INDIA ORAL SOLID 1.0X10.0X 11/29/2017
DP/6325 LABORATORIE PHARMACY TABLET EL LTD --L4 PHASEIII M.I.D.C ORDINARY 1.0X4.0
S PVT. LTD. (UGANDA) LTD AKOLA 444 104 TABLETS TABLET
MAHARASHTRA BLISTER
2927 NDA/MAL/H CIPLA QUALITY ONCOGEM GEMCITABIN 1000MG CIPLA LTD-UNIT VII INDIA PARENTERAL 1.0X1000. 12/20/2018
DP/6326 LIMITED CHEMICALS LTD - 1000 E PRODUCTION II, PLOT ORDINARY I 0 MG VIAL
HUMAN HYDROCHLOR NOS. S-103 TO S-105, S- V VIALS
IDE 107 TO S-112, L-147/1 TO
L-147/3, L-138, L-147/A,
VERNA INDUSTIRAL
ESTATE, VERNA SALCETTE-
GOA
2928 NDA/MAL/H BIOTON S.A. BHL GENSULIN INSULIN 100 IU/ML BIOTON S.A-MACIERZYSZ, POLAND PARENTERAL 1.0X1.0X1 3/28/2019
DP/6338 HEALTHCARE M30 HUMAN OF POZNANSKA 12 STR., 05- ORDINARY S 0.0 ML
LIMITED (30/70) RECOMBINAN 850 OZAROW C VIALS VIAL,1.0X
T DNA MAZOWIECKI 5.0X3.0
ORIGIN (30% ML
SOLUBLE CARTRIDG
INSULIN + E
70%
ISOPHANE
INSULIN)
2929 NDA/MAL/H EGYPTIAN WIDE OXY-POL OXYTETRACY 5MG+1000 EGYPTIAN EGYPT OPHTHALMI 1.0X5.0 G 5/30/2018
DP/6339 INTERNATION SPECTRUM CLINE HCL + 0IU/G INT.PHARMACEUTICAL C TUBE
AL ENTERPRISES POLYMYXIN B INDUSTRIES CO. E.I.P.C.O -- OINTMENTS
PHARMACEUT (U) LIMITED SULPHATE 10TH OF RAMADAN CITY –
ICAL INDUSTRIAL AREA B1- P.O
INDUSTRIES BOX: 149 TENTH - EGYPT
COMPANY
2930 NDA/MAL/H LABORATORY HARLEYS AXYLIN AMPICILLIN 250MG LABORATORY & ALLIED KENYA ORAL SOLID 1.0X10.0X 1/31/2018
DP/6340 & ALLIED LTD UGANDA CAPSULES TRIHYDRATE +250 MG LTD-PLOT NO. 209/10349 ORDINARY 10.0
LIMITED + OFF MOMBASA ROAD, CAPSULES CAPSULE
CLOXACILLIN NAIROBI BLISTER
SODIUM P.O. BOX 42875, NAIROBI,
KENYA.
2931 NDA/MAL/H MACLEODS NORVIK ROSUMAC ROSUVASTATI 20MG MACLEODS INDIA ORAL SOLID 1.0X3.0X1 1/31/2018
DP/6341 PHARMACEUT ENTERPRISES 20 N CALCIUM PHARMACEUTICALS LTD., ORDINARY 0.0
ICALS LTDS LIMITED NO. 25-27-PLOT NO. 25-26- FILM- TABLET
LTD 27, SURVEY NO.366, COATED BLISTER
PREMIER INDUSTRIAL TABLETS
ESTATE ., DAMAN -
396210, KACHIGAM,
DAMAN
2932 NDA/MAL/H EGYPTIAN WIDE EPIFENAC DICLOFENAC 1MG/ML EGYPTIAN EGYPT OPHTHALMI 1.0X1.0X5 5/30/2018
DP/6342 INTERNATION SPECTRUM EYE DROPS SODIUM SALT INTERNATIONAL C DROPS .0 ML
AL ENTERPRISES PHARMACEUTICAL BOTTLE
PHARMACEUT (U) LIMITED INDUSTRIES CO. A.R.E-
INDUSTRIES INDUSTRIAL AREA B
COMPANY EGYPT
2933 NDA/MAL/H BIOTON S.A. BHL GENSULIN ISOPHANE 100 IU/ML BIOTON S.A-MACIERZYSZ, POLAND PARENTERAL 1.0X1.0X1 3/28/2019
DP/6343 HEALTHCARE N HUMAN POZNANSKA 12 STR., 05- ORDINARY S 0.0 ML
LIMITED HUMAN OF 850 OZAROW C VIALS VIAL,1.0X
RECOMBINAN MAZOWIECKI 5.0X3.0
T DNA ML
ORIGIN CARTRIDG
E
2934 NDA/MAL/H S KAGE ABACUS LACTEASE LACTULOSE 66.7% S KANT HEALTHCARE LTD- INDIA ORAL LIQUID 1.0X1.0X1 9/26/2018
DP/6344 EXPORTS PHARMA SOLUTION W/W PLOT NO. 1802-1805, ORDINARY 00.0 ML
(AFRICA) G.I.D.C. PHASE III, VAPI LIQUIDS BOTTLE
LIMITED 396 195. GUJARAT.
2935 NDA/MAL/H SOUTH EGYPT WIDE MAGNABIO AMOXYCILLIN 500MG/10 SEDICO PHARMACEUTICAL EGYPT PARENTERAL 1.0X1.0 7/25/2018
DP/6345 DRUG SPECTRUM TIC 600MG SODIUM/ 0MG CO.-1ST INDUSTRIAL ZONE ORDINARY VIAL
INDUSTRIES ENTERPRISES VAIL CLAVULANAT 6 TH OCTOBER CITY DRY VIALS CARTON
CO. (SEDICO) (U) LIMITED E POTASSIUM GIZA,EGYPT
2936 NDA/MAL/H BIOTON S.A. BHL GENSULIN SOLUBLE 100 IU/ML BIOTON S.A-MACIERZYSZ, POLAND PARENTERAL 1.0X1.0X1 3/28/2019
DP/6346 HEALTHCARE R HUMAN POZNANSKA 12 STR., 05- ORDINARY S 0.0 ML
LIMITED INSULIN OF 850 OZAROW C VIALS VIAL,1.0X
RECOMBINAN MAZOWIECKI 5.0X3.0
T DNA ML
ORIGIN CARTRIDG
E
2937 NDA/MAL/H ABARIS ROYAL PHARMA COMPOUN SODIUM 0.533 GM ABARIS HEALTHCARE PVT. INDIA PARENTERAL 1.0X500.0 3/28/2018
DP/6348 HEALTHCARE 2011 LIMITED D SODIUM LACTATE +0.600 GM LTD--PLOT NO: 1407-1411 ORDINARY ML
PVT. LTD LACTATE SOLUTION + 0.027G+ VILLAGE: RAJPUR TALUKA: INFUSION BOTTLE
INTRAVEN +SODIUM 0.040 KADI, DIST.: MEHSANA VIALS/BOTTL
OUS CHLORIDE + GM/100ML 382 740, GUJARAT INDIA ES
INFUSION CALCIUM
BP CHLORIDE +
POTASSIUM
CHLORIDE
2938 NDA/MAL/H BLISS GVS DELMAW GSUNATE - ARTESUNATE 120MG BLISS INDASI LIFESCINCES INDIA PARENTERAL 1.0X1.0 9/26/2018
DP/6349 PHARMA ENTERPRISES 120 PRIVATE LIMITED - -PLOT ORDINARY VIAL
LIMITED LIMITED 73-76 SILVER INDUSTRIAL DRY VIALS CARTON
ESTATE, + 1*10ML
BHIMPORE, DAMAN 396 0.9%W/W
210, INDIA SODIUM
CHLORIDE
SOLUTION
AMPOULE
+ 1*2ML
5.0%W/W
SODIUM
2939 NDA/MAL/H BRAWN ESCORTS OMIPIN-20 OMEPRAZOLE 20MG BRAWN LABORATORIES INDIA ORAL SOLID 1.0X10.0X 3/28/2019
DP/6352 LABORATORIE PHARMACEUTIC LTD .-13, NIT, INDUSTRIAL ORDINARY 10.0
S LTD ALS LIMITED AREA, FARIDABAD-121001, OTHER CAPSULE
HARYANA CAPSULES STRIP
2940 NDA/MAL/H LAURUS LABS BEYOND DOLUTEGR DOLUTEGRAV 50MG+300 LAURUS LABS LIMITED, INDIA ORAL SOLID 1.0X1.0X3 12/11/2019
DP/6353 LIMITED - LOGISTICS LTD AVIR/LAMI IR+LAMIVUDI MG+300M (UNIT-2) - -PLOT NO:19, 20 ORDINARY 0.0
VUDINE/TE NE+TENOFOV G & 21,WESTERN SECTOR, FILM- TABLET
NOFOVIR IR APSEZ, COATED BOTTLE,1.
DISOPROXIL DISOPROXIL ATCHUTAPURAM TABLETS 0X1.0X90.
FUMARATE FUMARATE MANDAL, 0 TABLET
TABLETS TABLETS VISAKHAPATNAM- BOTTLE
50MG/300 DISTRICT-531011,
MG/300MG ANDHRA PRADESH, INDIA.
2941 NDA/MAL/H EXPHAR SA. SURGIPHARM TIMOSOL ® TIMOLOL O.5%W/V AHLCONPARENTERALS INDIA OPHTHALMI 1.0X5.0 7/1/2017
DP/6354 (U) LIMITED MALEATE (INDIA) LIMITED-SP-918, C DROPS ML
PHASE-III, BHIWADI- BOTTLE
301019, RAJASTHAN
(INDIA)
TEL: +91-1493-305300 (30
LINES)
FAX: +91-1493-221045,
305345
2942 NDA/MAL/H CADILA ABACUS ZYROVA 20 ROSUVASTATI 20MG CADILA HEALTHCARE INDIA ORAL SOLID 1.0X3.0X1 3/28/2019
DP/6358 HEALTH CARE PHARMA N CALCIUM LIMITED -KUNDAIM ORDINARY 0.0
LIMITED NO.203-213, KUNDAIM COATED STRIP
2943 NDA/MAL/H S K AGE ABACUS NYSKA-P NYSTATIN 1,00,000 S.KANT HEALTHCARE LTD- INDIA ORAL LIQUID 1.0X30.0 7/1/2017
DP/6361 EXPORTS PHARMA I.U/ML PLOT 1802, 1805, GIDC ORDINARY ML
(AFRICA) PHASE III VAPI 39179, SUSPENSION BOTTLE
LIMITED GUJARAT S
2944 NDA/MAL/H I CARE AIVEEN (U) EASY PILL LEVONORGES 1.5MG CORONA REMEDIES PVT INDIA ORAL SOLID 1.0X1.0 3/28/2019
DP/6365 PHARMA LIMITED TREL LTD-CORONA HOUSE, C ORDINARY TABLET
LIMITED MONDEAL BUSINESS TABLETS BLISTER
PARK, NR. GURUDWARA
GOVINDDHAM LANE, SG
HIGHWAY, THALTEJ,
AHMEDABAD 380059,
GUJARAT
2945 NDA/MAL/H I CARE AIVEEN (U) AIVXIM CEFIXIME 100MG/5 ASSOCIATED BIOTECH- INDIA ORAL LIQUID 1.0X60.0 1/31/2018
DP/6369 PHARMA LIMITED SUSPENSIO TRIHYDRATE ML VILLAGE : KISHANPURA, ORDINARY ML
LIMITED N GURU MAJRA, BADDI, DRY BOTTLE
DISTT. SOLAN, SUSPENSION
INDIA. S/SYRUPS/D
ROPS
2946 NDA/MAL/H LEBEN ANDYCO PREDLEB-5 PREDNISOLO 5MG LEBEN LABORATORIES INDIA ORAL SOLID 1.0X10.0X 3/28/2018
DP/6374 LABORATORIE PHARMACY DT NE PVT. LTD-PLOT NO. L-4, ORDINARY 20.0
S PVT. LTD., (UGANDA) LTD PHASE-III, MIDC, SOLUBLE TABLET
INDIA AKOLA– 444 104 (MS). TABLETS BLISTER
2947 NDA/MAL/H SOUTH EGYPT WIDE MAGNABIO AMOXICILLIN 1000MG+1 SEDICO PHARMACEUTICAL EGYPT PARENTERAL 1.0X1.2 G 7/25/2018
DP/6380 DRUG SPECTRUM TIC + 20MG CO.-1ST INDUSTRIAL ZONE ORDINARY VIAL
INDUSTRIES ENTERPRISES 1200MG CLAVULANIC 6 TH OCTOBER CITY DRY VIALS
CO. (SEDICO) (U) LIMITED VIAL ACID GIZA,EGYPT
2948 NDA/MAL/H EXPHAR SA. SURGIPHARM EXXIB CELECOXIB 200MG GRACURE INDIA ORAL SOLID 1.0X10.0 7/1/2017
DP/6383 (U) LIMITED PHARMACEUTICALS ORDINARY TABLET
LIMITED -E- 1105, RIICO TABLETS BLISTER
INDUSTRIAL AREA, PHASE-
III BHIWADI, PIN-301019
DIST. ALWAR, RAJASTHAN,
INDI
2949 NDA/MAL/H STEDMAN VEERAM JUSDEE 60K COLECALCIFE 60000 IU STEDMAN INDIA ORAL LIQUID 1.0X8.0X1 5/30/2018
DP/6386 PHARMACEUT HEALTHCARE GRANULES ROL PHARMACEUTICALS PVT ORDINARY .0 G
ICALS PVT. (U) LIMITED LIMITED-NO. C-4, SIDCO SOLUBLE SACHET
LTD PHARMACEUTICAL POWDERS
COMPLEX, ALATHUR,
THIRUPORUR,
2950 NDA/MAL/H IPCA MEDVIN RAPICLAV AMOXICILLIN 250MG + IPCA LABORATORIES LTD,.- INDIA ORAL SOLID 1.0X5.0X3 3/28/2018
DP/6388 LABORATORIE PHARMA 250 DT TRIHYDRATE 62.5MG PLOT 69 TO 72 (B), ORDINARY .0 TABLET
S LIMITED + POTASSIUM SECTOR II, KASEZ, SOLUBLE BLISTER
CLAVULANAT GANDHIDHAM - 370230, TABLETS
E GUJARAT
2951 NDA/MAL/H ABARIS ROYAL PHARMA METRONID METRONIDAZ 0.5%W/V ABARIS HEALTHCARE PVT. INDIA PARENTERAL 1.0X100.0 3/28/2018
DP/6389 HEALTHCARE 2011 LIMITED AZOLE BP OLE LTD--PLOT NO: 1407-1411 ORDINARY ML
PVT. LTD VILLAGE: RAJPUR TALUKA: INFUSION BOTTLE
KADI, DIST.: MEHSANA VIALS/BOTTL
382 740, GUJARAT INDIA ES
2952 NDA/MAL/H MACLEODS NORVIK ROSUMAC ROSUVASTATI 10MG MACLEODS INDIA ORAL SOLID 1.0X3.0X1 2/6/2019
DP/6390 PHARMACEUT ENTERPRISES 10 N CALCIUM PHARMACEUTICALS LTD ,.- ORDINARY 0.0
ICALS LTD LIMITED PHASE I & II, PLOT NO. 25- FILM- TABLET
27 SURVEY NO. 366, COATED STRIP
PREMIERE INDUSTRIAL TABLETS
ESTATE, KACHIGAN,
DAMAN-396210
2953 NDA/MAL/H AJANTA ABACUS MET XL 50 METOPROLOL 50 MG AJANTA PHARMA LTD .-B- INDIA ORAL SOLID 1.0X3.0X1 5/30/2018
DP/6392 PHARMA PHARMA SUCCINATE 4//5/6, MIDC RETARD 0.0
LIMITED (AFRICA) INDUSTRIALAREA, FILM- TABLET
LIMITED PAITHAN-431 128, COATED BLISTER
AURANGBAD TABLETS
2954 NDA/MAL/H NVS KENYA SURGIPHARM LETROZOLE LETROZOLE 2.5MG NOVARTIS PHARMA STEIN SWITZERLAN ORAL SOLID 1.0X3.0X1 7/1/2017
DP/6396 LTD (U) LIMITED 2.5 AG.-SCHAFF HAUSER D ORDINARY 0.0
STRASSE 4332, STEIN - FILM- TABLET
SWITZERLAND COATED BLISTER
TABLETS
2955 NDA/MAL/H MERIDIAN ABACUS INDOSUPP INDOMETHAC 100 MG MERIDIAN ENTERPRISES INDIA RECTAL 1.0X2.0X5 7/1/2017
DP/6397 ENTERPRISES PHARMA 100 IN PVT. LTD--PLOT NO. 418, SYSTEMIC .0
PRIVATE (AFRICA) G.I.D.C.,KABILPORE, SUPPOSITORI SUPPOSIT
LIMITED. LIMITED NAVSARI 396424 ES ORY STRIP
GUJARAT,INDIA
2956 NDA/MAL/H MERIDIAN ABACUS FENSUPP- DICLOFENAC 100MG MERIDIAN ENTERPRISES INDIA RECTAL 1.0X2.0X5 7/1/2017
DP/6400 ENTERPRISES PHARMA 100 SODIUM PVT. LTD--PLOT NO. 418, SYSTEMIC .0
PRIVATE (AFRICA) G.I.D.C.,KABILPORE, ADULT SUPPOSIT
LIMITED. LIMITED NAVSARI 396424 SUPPOSITORI ORY STRIP
GUJARAT,INDIA ES
2957 NDA/MAL/H MERIDIAN ABACUS SUPPOL ACETAMINOP 250MG MERIDIAN ENTERPRISES INDIA RECTAL 1.0X5.0 7/1/2017
DP/6401 ENTERPRISES PHARMA 250 HEN PVT. LTD-PLOT NO. 418, SYSTEMIC SUPPOSIT
PRIVATE (AFRICA) SUPPOSITO G.I.D.C.,KABILPORE,NAVSA SUPPOSITORI ORY STRIP
LIMITED. LIMITED RIES RI 396424 GUJARAT,INDIA ES
2958 NDA/MAL/H STEDMAN VEERAM STEDNAC ACECLOFENA 1.5%W/W STEDMAN INDIA TOPICAL 1.0X30.0 7/1/2017
DP/6404 PHARMACEUT HEALTHCARE GEL C + LINSEED + 3.0W/W PHARMACEUTICALS PVT EXTERNAL G TUBE
ICALS PVT. (U) LIMITED OIL + METHYL +10.0%W/ LIMITED-NO. C-4, SIDCO GELS AND
LTD SALICYLATE W PHARMACEUTICAL SOLS
COMPLEX, ALATHUR,
THIRUPORUR,
2959 NDA/MAL/H ZIM GITTOES CLOPRAZ CLOPIDOGREL 75MG ZIM LABORATORIES LTD-B- INDIA ORAL SOLID 1.0X3.0X1 7/1/2017
DP/6405 LABORATORIE PHARMACEUTIC BISULFATE 21/22, M.I.D.C. AREA, ORDINARY 0.0
S LTD ALS LIMITED KALMESHWAR – 441501, FILM- TABLET
DIST. NAGPUR, COATED BLISTER
MAHARASHTRA, TABLETS
2960 NDA/MAL/H LINCOLN METRO LIDOCAINE LIDOCAINE 2% W/V LINCOLN PARENTERAL LTD- INDIA PARENTERAL 1.0X25.0X 2/6/2019
DP/6406 PARENTERAL PHARMACEUTIC INJECTION HYDROCHLOR 11, TRIMUL ESTATE, NEAR ORDINARY 30.0 ML
LIMITED ALS LIMITED BP 2% IDE KHATRAJ CHOLADI, P.O. VIALS VIAL
KHATRAJ-382721 TA:
KALOL, DIST.
2961 NDA/MAL/H ZIM GITTOES ZIMCOX CELECOXIB 200 MG ZIM LABORATORIES LTD-B- INDIA ORAL SOLID 1.0X3.0X1 11/29/2017
DP/6407 LABORATORIE PHARMACEUTIC 200 21/22, M.I.D.C. AREA, ORDINARY 0.0
S LTD ALS LIMITED KALMESHWAR – 441501, CAPSULES CAPSULE
DIST. NAGPUR, BLISTER
MAHARASHTRA,
2962 NDA/MAL/H AMMAN WIDE DECOZAL XYLOMETAZO 0.1%W/V AMMAN JORDAN NASAL 1.0X10.0 5/29/2019
DP/6408 PHARMACEUT SPECTRUM LINE HCL PHARMACEUTICALS TOPICAL ML
ICAL ENTERPRISES INDUSTRIES-KING METERED BOTTLE
INDUSTRIES (U) LIMITED ABDULLAH II, INDUSTRIAL DOSE
ESTATE, SAHAB, AMMAN AEROSOLS
2963 NDA/MAL/H S KAGE ABACUS ERYTHROK ERYTHROMYC 250MG/5 S KANT HEALTHCARE LTD- INDIA ORAL LIQUID 1.0X1.0X1
DP/6410 EXPORTS PHARMA ANT ES-DS IN ETHYL ML PLOT NO. 1802-1805, ORDINARY 00.0 ML
(AFRICA) SUCCINATE G.I.D.C. PHASE III, VAPI OTHER BOTTLE,1.
LIMITED 396 195. GUJARAT. POWDERS/G 0X60.0 ML
RANULES BOTTLE
2964 NDA/MAL/H PHARCO WIDE BUCCAZOLE MICONAZOLE 2%W/W PHARCO EGYPT ORAL 1.0X20.0 7/1/2017
DP/6412 PHARMACEUT SPECTRUM ORAL GEL PHARMACEUTICALS LTD- TOPICAL G TUBE
ICALS LTD ENTERPRISES KILO 31 ALEXANDRIA, GELS AND
(U) LIMITED CAIRO DESERT ROAD, SOLS
ALEXANDRIA EGYPT
2965 NDA/MAL/H CRATUS ABACUS CLINICEF CEFIXIME + 200MG + TWENTY FIRST CENTURY INDIA ORAL SOLID 1.0X1.0X1 9/26/2018
DP/6419 PHARMA PVT. PHARMA CV POTASSIUM 125MG PHARMACEUTICALS ORDINARY 0.0
LTD (AFRICA) CLAVULANAT PVT.LTD - -UNIT II, FILM- TABLET
LIMITED E KHASRA NO: 282, NALHERI COATED BLISTER
DEHVIRAN, TABLETS
NALHERA
ANANTPUR,PUHANA -
IQBALPUR ROAD,
ROORKEE-247668. DIST.-
HARIDWAR,
UTTARAKHAND
2966 NDA/MAL/H ABARIS ROYAL PHARMA SODIUM SODIUM 0.9%W/V ABARIS HEALTHCARE PVT. INDIA PARENTERAL 1.0X500.0 7/1/2017
DP/6426 HEALTHCARE 2011 LIMITED CHLORIDE CHLORIDE LTD--PLOT NO: 1407-1411 ORDINARY ML
PVT. LTD INTRAVEN VILLAGE: RAJPUR TALUKA: INFUSION BOTTLE
OUS KADI, DIST.: MEHSANA VIALS/BOTTL
INFUSION 382 740, GUJARAT INDIA ES
BP
2967 NDA/MAL/H IPCA MEDVIN LUMERAX ARTEMETHER 20 MG + IPCA LABORATORIES INDIA ORAL SOLID 1.0X30.0X 3/27/2019
DP/6430 LABORATOIES PHARMA DT 20/120 + 120 MG LIMITED .-PLOT 225/1, ORDINARY 1.0X6.0
LTD LIMITED LUMEFANTRI VILLAGE ATHAL, DANDRA SOLUBLE TABLET
NE AND NAGAR HAVELI TABLETS BLISTER,1.
UNION TERRITORY, 0X30.0X1.
SILVASSA-396 230 0X12.0
TABLET
BLISTER
2968 NDA/MAL/H BRAWN ESCORTS BRUMOX AMOXICILLIN 125MG/5 BRAWN LABORATORIES INDIA ORAL LIQUID 1.0X100.0 7/1/2017
DP/6431 LABORATORIE PHARMACEUTIC 125 TRIHYDRATE ML LTD.-13, NIT, INDUSTRIAL ORDINARY ML
S LTD ALS LIMITED AREA, FARIDABAD-121001, DRY BOTTLE
HARYANA SUSPENSION
S/SYRUPS/D
ROPS
2969 NDA/MAL/H BRAWN ESCORTS FICYC ACICLOVIR 5%W/W BRAWN LABORATORIES INDIA TOPICAL 1.0X10.0 7/1/2017
DP/6433 LABORATORIE PHARMACEUTIC CREAM LTD.-13, NIT, INDUSTRIAL EXTERNAL G TUBE
S LTD ALS LIMITED AREA, FARIDABAD-121001, CREAMS
HARYANA
2970 NDA/MAL/H BRAWN ESCORTS FIMABUTE CEFIXIME 200MG BRAWN LABORATORIES INDIA ORAL SOLID 1.0X10.0 7/1/2017
DP/6435 LABORATORIE PHARMACEUTIC 200 TRIHYDRATE LTD.-13, NIT, INDUSTRIAL ORDINARY TABLET
S LTD ALS LIMITED AREA, FARIDABAD-121001, FILM- BLISTER
HARYANA COATED
TABLETS
2971 NDA/MAL/H GUILIN STAR MOXAF MOXIFLOXACI 400 MG GUILIN PHARMACEUTICAL CHINA ORAL SOLID 1.0X5.0 7/1/2017
DP/6436 PHARMACEUT PHARMACEUTIC N CO LTD-NO.43 QILIDIAN ORDINARY TABLET
ICALS CO.LTD ALS LTD HYDROCHLOR ROAD GUILIN 541004 FILM- BLISTER
IDE GUANGXI COATED
TABLETS
2972 NDA/MAL/H MERIDIAN ABACUS PILORECT HYDROCORTI 0.25%W/W MERIDIAN ENTERPRISES INDIA RECTAL 1.0X1.0X6 11/29/2017
DP/6437 ENTERPRISES PHARMA SONE +3%W/W+ PVT. LTD-PLOT NO. 418, SYSTEMIC .0
PRIVATE (AFRICA) ACETATE 5%W/W+0. G.I.D.C., SUPPOSITORI SUPPOSIT
LIMITED. LIMITED +LIDOCAINE 5%W/W KABILPORE, NAVSARI ES ORY STRIP
+ZINC OXIDE GUJARAT,INDIA
+ALLANTOIN
2973 NDA/MAL/H MACLEODS NORVIK LIZOMAC LINEZOLID 600MG MACLEODS INDIA ORAL SOLID 1.0X6.0X1 7/1/2017
DP/6439 PHARMACEUT ENTERPRISES 600 PHARMACEUTICALS ORDINARY 0.0
ICALS LTD LIMITED LIMITED -BLOCK-N2 FILM- TABLET
VILLAGE THEDA POST COATED STRIP,1.0X
OFFICE LODHIMAJRA TABLETS 10.0X10.0
TEHSIL BADDI DISTRICT TABLET
SOLAN HIMACHAL STRIP
PRADESH – 174101
INDIA
2974 NDA/MAL/H UNOSOURCE ABACUS CEFIWEL CEFIXIME 400MG MALIK LIFESCIENCES INDIA ORAL SOLID 1.0X1.0X1 3/28/2018
DP/6440 PHARMA LTD. PHARMA 400 TRIHYDRATE PRIVATE LIMITED-PLOT ORDINARY 0.0
(AFRICA) NO. 16, NH 58, FILM- TABLET
LIMITED VARDHMAN INDUTRIAL COATED BLISTER
ESTATE, VILLAGE TABLETS
BAHADARPUR SAINI
HARIDWAR,
UTTARAKHAND-247667
2975 NDA/MAL/H ZIM GITTOES AZITO AZITHROMYCI 200 ZIM LABORATORIES LTD-B- INDIA ORAL LIQUID 1.0X30.0 1/31/2018
DP/6442 LABORATORIE PHARMACEUTIC SUSPENSIO N DIHYDRATE MG/5ML 21/22, M.I.D.C. AREA, ORDINARY ML
S LTD ALS LIMITED N KALMESHWAR – 441501, DRY BOTTLE,1.
DIST. NAGPUR, SUSPENSION 0X15.0 ML
MAHARASHTRA, S/SYRUPS/D BOTTLE
ROPS
2976 NDA/MAL/H ZIM GITTOES CEFRAZ 100 CEFIXIME 100MG ZIM LABORATORIES LTD-B- INDIA ORAL SOLID 1.0X2.0X1 1/31/2018
DP/6444 LABORATORIE PHARMACEUTIC TRIHYDRATE 21/22, M.I.D.C. AREA, ORDINARY 0.0
S LTD ALS LIMITED KALMESHWAR – 441501, SOLUBLE TABLET
DIST. NAGPUR, TABLETS BLISTER
MAHARASHTRA,
2977 NDA/MAL/H BRAWN ESCORTS AZIBRU 500 AZITHROMYCI 500MG BRAWN LABORATORIES INDIA ORAL SOLID 1.0X3.0 7/1/2017
DP/6447 LABORATORIE PHARMACEUTIC N DIHYDRATE LTD.-13, NIT, INDUSTRIAL ORDINARY TABLET
HARYANA COATED
TABLETS
2978 NDA/MAL/H EGYPTIAN WIDE EPIZOLONE- METHYLPRED 40 MG/ ML EGYPTIAN EGYPT PARENTERAL 1.0X1.0X1 7/25/2018
DP/6448 INTERNATION SPECTRUM DEPOT 40 NISOLONE INTERNATIONAL ORDINARY .0 ML
AL ENTERPRISES MG/ 1 ML ACETATE PHARMACEUTICAL VIALS VIAL
PHARMACEUT (U) LIMITED VIAL INDUSTRIES CO. A.R.E-
INDUSTRIES INDUSTRIAL AREA
COMPANY B1,EGYPT
2979 NDA/MAL/H EVA PHARMA GAMA DESLORAT DESLORATIDI 0.5MG/ML EVA PHARMA FOR EGYPT ORAL LIQUID 1.0X100.0 7/1/2017
DP/6449 FOR PHARMACEUTIC SYRUP NE PHARMACEUTICALS AND ORDINARY ML
PHARMACEUT ALS (U) LIMITED MEDICAL APPLIANCES-176 SYRUPS BOTTLE
ICALS & EL SADAT ST. KAFR EL
MEDICAL GABAL, PYRAMIDS, GIZA,
APPLIANCES EGYPT
2980 NDA/MAL/H SANDOZ SURGIPHARM AMLODIPIN AMLODIPINE 5MG LEK PHARMACEUTICALS INDIA ORAL SOLID 1.0X3.0X1 3/27/2019
DP/6452 GMBH . (U) LIMITED E 5MG DD-VEROVSKOVA 57, SI- ORDINARY 0.0
TABLETS 1526 LJUBLJANA FILM- TABLET
COATED BLISTER
TABLETS
2981 NDA/MAL/H LINCOLN METRO ALLMYCIN ERYTHROMYC 125 MG/5 LINCOLN INDIA ORAL LIQUID 1.0X100.0 3/27/2019
DP/6453 PHARMACEUT PHARMACEUTIC IN STEARATE ML PHARMACEUTICALS LTD .,.- ORDINARY ML
ICALS LTD ALS LIMITED 10,12,13, TRIMUL ESTATE, SUSPENSION BOTTLE
NEAR KHATRAJ CHOKADI, S WITH
P.O. BOX KHATRAJ-382721 10ML
TA: KALOL, DIST. PLASTIC
GHANDINAGAR, GUJARAT DOSING
CAP
2982 NDA/MAL/H BRAWN ESCORTS FICYC ACYCLOVIR 200MG BRAWN LABORATORIES INDIA ORAL SOLID 1.0X10.0X 7/1/2017
DP/6455 LABORATORIE PHARMACEUTIC TABLETS LTD.-13, NIT, INDUSTRIAL ORDINARY 10.0
S LTD ALS LIMITED AREA, FARIDABAD-121001, TABLETS TABLET
HARYANA BLISTER
2983 NDA/MAL/H ABARIS ROYAL PHARMA GLUCOSE GLUCOSE 5%W/V ABARIS HEALTHCARE PVT. INDIA PARENTERAL 1.0X500.0 7/1/2017
DP/6456 HEALTHCARE 2011 LIMITED INTRAVEN ANHYDROUS LTD--PLOT NO: 1407-1411 ORDINARY ML
PVT. LTD OUS VILLAGE: RAJPUR TALUKA: INFUSION BOTTLE
INFUSION KADI, DIST.: MEHSANA VIALS/BOTTL
BP (5% 382 740, GUJARAT INDIA ES
W/V)
2984 NDA/MAL/H LIPTIS EGYPT ERIS LTD VAXATO RIVAROXABA 10 MG LIPTIS EGYPY FOR EGYPT ORAL SOLID 1.0X1.0X1 3/27/2019
DP/6458 FOR N PHARMACEUTICALS AND ORDINARY 0.0
PHARMACEUT MEDICAL PRODUCTS-PLOT FILM- TABLET
ICALS AND NO. 2/B, 6TH INDUSTRIAL COATED BLISTER
MEDICAL ZONE, 6TH OF OCTOBER TABLETS
PRODUCTS CITY
2985 NDA/MAL/H MACLEODS NORVIK MACSUNAT ARTESUNATE 100MG + MACLEODS INDIA ORAL SOLID 1.0X1.0X3 3/27/2019
DP/6459 PHARMACEUT ENTERPRISES E AQ FORTE + 270MG PHARMACEUTICALS LTD ,.- ORDINARY .0 TABLET
ICALS LTDS LIMITED AMODIAQUIN PHASE I & II, PLOT NO. 25- TABLETS BLISTER,1.
LTD E 27 SURVEY NO. 366, 0X25.0X3.
PREMIERE INDUSTRIAL 0 TABLET
ESTATE, KACHIGAN, BLISTER,1.
DAMAN-396210 0X25.0X6.
0 TABLET
BLISTER
2986 NDA/MAL/H MACLEODS NORVIK NEUROGAB PREGABALIN 75MG MACLEODS INDIA ORAL SOLID 1.0X3.0X1 7/1/2017
ICALS LTD LIMITED LIMITED -BLOCK-N2 CAPSULES CAPSULE
VILLAGE THEDA POST BLISTER
OFFICE LODHIMAJRA
SOLAN HIMACHAL
PRADESH – 174101
INDIA
2987 NDA/MAL/H MERCK UNITED EUTHROX LEVOTHYROXI 75 MCG MERCK KGAA-PHARMA GERMANY ORAL SOLID 1.0X2.0X2 3/27/2019
DP/6482 PHARMACEUT HEALTHCARE 75MCG NE SODIUM PRODUCTION ORDINARY 5.0
ICAL DISTRIBUTORS DARMSTADT - TABLETS TABLET
MANUFACTU LTD FRANKFURTER STRABE BLISTER
RING (PYT) 250, D-64293,
LTD DARMSTADT
2988 NDA/MAL/H GUILIN PHILLIPS PARACETA PARACETAM 300MG/2 GUILIN PHARMACEUTICAL CHINA PARENTERAL 1.0X10.0X 5/30/2018
DP/6488 PHARMACEUT PHARMACEUTIC MOL OL ML CO LTD-NO.43 QILIDIAN ORDINARY 10.0X2.0
ICAL CO.LTD ALS (UGANDA) INJECTION ROAD GUILIN 541004 AMPOULES ML
LIMITED GUANGXI AMPOULE
2989 NDA/MAL/H GLENMARK STAR ASCORIL-SF SALBUTAMOL 2MG+4MG GLENMARK INDIA ORAL LIQUID 1.0X100.0 7/1/2017
DP/6489 PHARMACEUT PHARMACEUTIC +BROMHEXIN +100MG/1 PHARMACEUTICALS LTD .- ORDINARY ML
ICALS LTD ALS LTD E 0ML VILLAGE KISHANPURA, SYRUPS BOTTLE
HYDROCHLOR BADDI-NALAGARH ROAD,
IDE+GUAIFEN TEHSIL BADDI, DISTRICT
ESIN SOLAN HP 173205
2990 NDA/MAL/H INTAS NORVIK PREGATAS PREGABALIN 75MG+750 INTAS PHARMACEUTICALS INDIA ORAL SOLID 1.0X3.0X1 3/28/2018
DP/6491 PHARMACEUT ENTERPRISES ME 75 +MECOBALA MCG LIMITED -CAMP ROAD, ORDINARY 0.0
ICALS LIMITED LIMITED MIN SELAQUI- CAPSULES CAPSULE
UTTARAKHAND, INDIA
2991 NDA/MAL/H UMEDICA VITACARE LIDOCAINE LIDOCAINE 2%W/V UMEDICA LABORATORIES INDIA PARENTERAL 1.0X10.0X 7/1/2006
DP/6492 LABORATORIE LIMITED INJECTION HYDROCHLOR PVT, VAPI - -PLOT 221, ORDINARY 20.0 ML
S PVT LTD BP 2%W/V IDE GIDC II, VAPI-396195, VIALS VIAL
VALSAD GUJARAT INDIA
2992 NDA/MAL/H DAFRA LABOREX MACROLYN AZITHROMYCI 500MG DEVA HOLDING A. S.- TURKEY ORAL SOLID 1.0X1.0X3 11/29/2017
DP/6495 PHARMA UGANDA ® 500 MG N DIHYDRATE ÇERKEZKÖY ORGANIZE ORDINARY .0 TABLET
GMBH LIMITED FILM SANAYI BOLGESI. FILM- BLISTER
COATED KARAAĞAÇ MAH. COATED
TABLETS ATATÜRK CAD. NO: 32 TABLETS
KAPAKLI- TEKIRDAĞ/
TURKEY
2993 NDA/MAL/H MICRO LABS PHARMA VILLE AMOXICILLI AMOXICILLIN 250MG MICRO LABS LIMITED INDIA ORAL SOLID 1.0X10.0X 7/25/2018
DP/6498 LIMITED LIMITED N TRIHYDRATE PLOT -NO. 16, ORDINARY 10.0
DISPERSIBL VEERASANDRA SOLUBLE TABLET
E TABLETS INDUSTRIAL AREA, TABLETS STRIP
250 MG ANEKAL TALUK,
BANGALORE – 560 100.
KARNATAKA, INDIA
2994 NDA/MAL/H PINNACLE METRO AARTROGY METRONIDAZ 200MG PINNACLE LIFE SCIENCE INDIA ORAL SOLID 1.0X10.0X 11/29/2017
DP/6501 LIFE SCIENCE PHARMACEUTIC L 200 OLE PVT LTD-KHASRA NO. ORDINARY 10.0
PVT. LTD. ALS LIMITED TABLET 1328-1330, VILLAG FILM- TABLET
MANPURA, TEHSIL, BADDI, COATED BLISTER
DIST. SOLAN (HP) TABLETS
2995 NDA/MAL/H IPCA MEDVIN DICHLOR- CHLORTHALID 12.5MG IPCA LABORATORIES INDIA ORAL SOLID 1.0X3.0X1 5/29/2019
DP/6503 LABORATORIE PHARMA 12.5 ONE LIMITED-P.O SEJAVTA ORDINARY 0.0
S LTD LIMITED DIST. RATLAM-457002, TABLETS TABLET
MADHYA PRADESH, INDIA BLISTER
2996 NDA/MAL/H ASTRA ASTRA PHARMA ASPYROX PIROXICAM 20MG ASTRA LIFE CARE(INDIA) INDIA ORAL SOLID 1.0X3.0X1 7/1/2017
DP/6509 LIFECARE (U) LIMITED PVT LTD-PLOT NO. 57/P, ORDINARY 0.0
(INDIA) PVT. SARKHEJ – BAVLA CAPSULES CAPSULE
LTD HIGHWAY, POST. RAJODA BLISTER,1.
– 382220, TALUKA: BAVLA, 0X10.0X10
DIST. AHMEDABAD .0
CAPSULE
BLISTER
2997 NDA/MAL/H AXA VITACARE AXACIP CIPROFLOXAC 200MG/10 AXA PARENTERAL LIMITED- INDIA PARENTERAL 1.0X100.0 1/31/2018
DP/6512 PARENTERALS LIMITED IN 0ML PLOT NO.936,937&939, ORDINARY ML
2998 NDA/MAL/H MEGA ABACUS FERROTON FERROUS 100MG + FDC LIMITED, WALUJ .- INDIA ORAL LIQUID 1.0X60.0 5/29/2019
DP/6517 LIFESCIENCES PHARMA E LIQUIZ FUMARATE + 0.5MG + PLOT NO. B-8, MIDC, ORDINARY ML
PUBLIC (AFRICA) FOLIC ACID + 5MCG INDUSTRIAL AREA, WALUJ SUSPENSION BOTTLE,1.
COMPANY LIMITED CYANOCOBAL 431136 DIST S 0X120.0
LTD AMIN AURANGABAD ML
BOTTLE,1.
0X180.0
ML
BOTTLE
2999 NDA/MAL/H MYLAN KIMSY MEDS CARDISAR VALSARTAN + 80 MG + AIZANT DRUG RESEARCH INDIA ORAL SOLID 1.0X3.0X1 8/28/2019
DP/6518 PHARMACEUT LTD HT HYDROCHLOR 25 MG SOLUTIONS PVT LTD-SY. ORDINARY 0.0
ICAL PRIVATE OTHIAZIDE NO 172 &. 173, APPAREL FILM- TABLET
LIMITED, PARK ROAD, DULAPALLY COATED BLISTER
INDIA VILLAGE, QUTHBULLAPUR TABLETS
MANDAL, RR DIST.,
HYDERABAD- 500 100,
TELANGANA
3000 NDA/MAL/H MANKIND TATA UGANDA VOMIKIND- ONDASENTR 8MG MANKIND PHARMA LTD-- INDIA ORAL SOLID 1.0X10.0 7/1/2017
DP/6520 PHARMA LIMITED MD 8 ON UNIT II VILLAGE ORDINARY TABLET
LIMITED KISHANPURA P.O TABLETS BLISTER
JAMNIWALA TEHSIL
PAONTA SAHIB DISTRICT
SIRMOUR 173 025
HIMACHAL PRADESH
3001 NDA/MAL/H MSN ABACUS EPNONE 25 EPLERENONE 25MG MSN LABORATORIES LTD. - INDIA ORAL SOLID 1.0X3.0X1 3/28/2019
DP/6522 LABORATORIE PHARMA PLOT NO. 42, ANRICH ORDINARY 0.0
S PRIVATE (AFRICA) INDUSTRIAL ESTATE, FILM- TABLET
LIMITED LIMITED BOLLARAM, MEDAK COATED BLISTER
DISTRICT, ZIP CODE - 502 TABLETS
325, ANDHRA PRADESH
3002 NDA/MAL/H EXPHAR SA. SURGIPHARM FLEXDOL IBUPROFEN+ 200MG+50 GRACURE INDIA ORAL SOLID 1.0X10.0 7/1/2017
DP/6523 (U) LIMITED METHOCARB 0MG PHARMACEUTICAL LTD-E- ORDINARY TABLET
AMOL 1105, RIICO IND. AREA, TABLETS BLISTER
PHASE III, BHIWADI,
DISTRICT ALWAR
(RAJASTHAN)
3003 NDA/MAL/H MSN METRO RAMGIC TRAMADOL 50MG/ML MSN LABORATORIES LTD. - INDIA PARENTERAL 1.0X1.0X5 3/28/2019
DP/6524 LABORATORIE PHARMACEUTIC HYDROCHLOR PLOT NO. 42, ANRICH ORDINARY .0X2.0 ML
S PRIVATE ALS LIMITED IDE INDUSTRIAL ESTATE, AMPOULES AMPOULE
LIMITED BOLLARAM, MEDAK
DISTRICT, ZIP CODE - 502
325, ANDHRA PRADESH
3004 NDA/MAL/H MSN METRO DAPOXEM DAPOXETINE 30MG MSN LABORATORIES LTD. - INDIA ORAL SOLID 1.0X3.0X1 3/28/2019
DP/6525 LABORATORIE PHARMACEUTIC 30 PLOT NO. 42, ANRICH ORDINARY 0.0
S PRIVATE ALS LIMITED INDUSTRIAL ESTATE, FILM- TABLET
LIMITED BOLLARAM, MEDAK COATED BLISTER
325, ANDHRA PRADESH
3005 NDA/MAL/H MSN METRO DAPOXEM DAPOXETINE 60MG MSN LABORATORIES LTD. - INDIA ORAL SOLID 1.0X3.0X1 3/28/2019
DP/6526 LABORATORIE PHARMACEUTIC 60 PLOT NO. 42, ANRICH ORDINARY 0.0
S PRIVATE ALS LIMITED INDUSTRIAL ESTATE, FILM- TABLET
LIMITED BOLLARAM, MEDAK COATED BLISTER
325, ANDHRA PRADESH
3006 NDA/MAL/H MSN ABACUS PULMOFIRS BOSENTAN 62.5MG MSN LABORATORIES LTD. - INDIA ORAL SOLID 1.0X1.0X1 3/28/2019
DP/6527 LABORATORIE PHARMA T 62.5 MONOHYDRA PLOT NO. 42, ANRICH ORDINARY 0.0
S PRIVATE (AFRICA) TE INDUSTRIAL ESTATE, TABLETS TABLET
LIMITED LIMITED BOLLARAM, MEDAK BLISTER
325, ANDHRA PRADESH
3007 NDA/MAL/H MSN ABACUS PULMOFIRS BOSENTAN 125MG MSN LABORATORIES LTD. - INDIA ORAL SOLID 1.0X1.0X1 3/28/2019
DP/6528 LABORATORIE PHARMA T 125 MONOHYDRA PLOT NO. 42, ANRICH ORDINARY 0.0
S PRIVATE (AFRICA) TE INDUSTRIAL ESTATE, TABLETS TABLET
LIMITED LIMITED BOLLARAM, MEDAK BLISTER
325, ANDHRA PRADESH
3008 NDA/MAL/H MACLEODS NORVIK PRAZIQUA PRAZIQUANT 600MG MACLEODS INDIA ORAL SOLID 1.0X10.0X 3/28/2018
DP/6529 PHARMACEUT ENTERPRISES NTEL EL PHARMACEUTICALS ORDINARY 10.0
ICALS LTD LIMITED TABLETS LIMITED -BLOCK-N2 FILM- TABLET
600 MG VILLAGE THEDA POST COATED BLISTER,1.
OFFICE LODHIMAJRA TABLETS 0X50.0X10
TEHSIL BADDI DISTRICT .0 TABLET
SOLAN HIMACHAL BLISTER
PRADESH – 174101
INDIA
3009 NDA/MAL/H MACLEODS NORVIK BUNASE BUDESONIDE 200MCG / OXALIS LABS--VILLAGE INDIA LUNG 1.0X1.0 3/28/2018
DP/6532 PHARMACEUT ENTERPRISES 200 ACTUATIO THEDA,P.O.LODHIMAJRA ADMINISTRA CANNISTE
ICALS LTD LIMITED N ,TEHSIL BADDI,DIST TION CFC- R CARTON
.SOLAN (HIMACHAL FREE
PRADESH) - 174101 METERED-
INDIA DOSE
INHALER
3010 NDA/MAL/H INDOCO STAR REXIDIN CHLORHEXIDI 0.2%W/V INDOCO REMEDIES LTD, B- INDIA ORAL 1.0X100.0 7/1/2017
DP/6534 REMEDIES PHARMACEUTIC NE 20,-B-20 MIDC, WALUJ, TOPICAL ML
LIMITED ALS LTD GLUCONATE AURANGABAB 431136 LIQUIDS BOTTLE
INDIA
3011 NDA/MAL/H EXPHAR SA SURGIPHARM CARBOSOL CARMELLOSE 0.5%W/V AHLCONPARENTERALS INDIA OPHTHALMI 1.0X10.0 1/31/2018
DP/6537 (U) LIMITED SODIUM (INDIA) LIMITED-SP-918, C DROPS ML
PHASE-III, BHIWADI- BOTTLE
301019, RAJASTHAN
(INDIA)
TEL: +91-1493-305300 (30
LINES)
FAX: +91-1493-221045,
305345
3012 NDA/MAL/H CIRON ROYAL PHARMA CIROPAIN DICLOFENAC 1%W/W CIRON DRUGS & INDIA TOPICAL 1.0X20.0 7/1/2017
DP/6548 DRUGS & 2011 LIMITED GEL DIETHYLAMIN PHARMACEUTICALS PVT EXTERNAL G TUBE
PHARMACEUT E BP LTD--N-118, 119 MIDC GELS AND
ICAL PVT LTD TARAPUR BOISAR DIST SOLS
THANE 4011 506
3013 NDA/MAL/H EAST AFRICAN ROYAL PHARMA DERMIRIV OFLOXACIN + 0.75%W/W EAST AFRICAN (INDIA) INDIA TOPICAL 1.0X1.0X1 8/28/2019
DP/6555 (INDIA) 2011 LIMITED OC ORNIDAZOLE + OVERSEAS-PLOT NO.1, EXTERNAL 5.0 G
OVERSEAS + 2.0%W/W PHARMACITY SELAQUI CREAMS TUBE
TERBINAFINE + DEHRADUN – 248011
HYDROCHLOR 1.0%W/W (U.K), INDIA
IDE + +
CLOBETASOL 0.05%W/W
PROPIONATE
3014 NDA/MAL/H SURGE LAB JEET BIOCOBAL MECOBALAMI 500MCG / SURGE LABORATORIES PAKISTAN PARENTERAL 1.0X2.0X5 3/28/2019
DP/6559 (PVT) LIMITED PHARMACEUTIC 500MCG N ML (PVT) LTD.,,-10TH KM, ORDINARY .0X1.0 ML
ALS LIMITED FAISALABAD ROAD, BIKHI, AMPOULES AMPOULE
DISTRICT SHEIKHUPURA-
PAKISTAN.
3015 NDA/MAL/H TRIVENI AIVEEN (U) IBUPROFEN IBUPROFEN 200MG TRIVENI FORMULATIONS INDIA ORAL SOLID 1.0X10.0X 3/28/2019
DP/6565 FORMULATIO LIMITED LTD-PLOT NO. ORDINARY 10.0
NS LIMITED 52,53,54,63,62,64 ALEAP TABLETS TABLET
INDUSTRIUAL ESTATE BLISTER
SARAMPALLI VIJAYWADA
3016 NDA/MAL/H PINNACLE METRO PINNADIP DICLOFENAC 50MG PINNACLE LIFE SCIENCE INDIA ORAL SOLID 1.0X10.0X 7/1/2017
DP/6568 LIFE SCIENCE PHARMACEUTIC 50 TABLET PVT LTD-KHASRA NO. ORDINARY 10.0
PVT. LTD. ALS LIMITED 1328-1330, VILLAG FILM- TABLET
3017 NDA/MAL/H ABACUS ABACUS ABTOL MANNITOL 10%W/V KAMPALA UGANDA PARENTERAL 1.0X500.0 1/13/2020
DP/6571 PARENTERAL PARENTERAL PHARMACEUTICALS ORDINARY ML
DRUGS DRUGS LIMITED INDUSTRIES (1996)LTD- INFUSION BOTTLE
LIMITED STRETCHER ROAD PLOT VIALS/BOTTL
M444B NTINDA ES
KAMPALA
3018 NDA/MAL/H MEDOCHEMIE BOOTS ARCHIFAR MEROPENEM 1G MEDOCHEMIE LTD CYPRUS PARENTERAL 1.0X10.0X 7/1/2017
DP/6574 LTD PHARMACEUTIC COGOLS FACILITY-1-10 ORDINARY 1.0 G VIAL
ALS LIMITED CONSTANTINOUPOLEOS DRY VIALS
STREET, ZAKAKI,
LIMASSOL, CYPRUS
3019 NDA/MAL/H BROOKES HARLEYS SENSOCAIN BUPIVACAINE 0.75% W/V BROOKES PHARMA PAKISTAN PARENTERAL 1.0X5.0X2 8/28/2019
DP/6575 PHARMA UGANDA HYDROCHLOR (PRIVATE) LIMITED-58-59, ORDINARY .0 ML
(PRIVATE) LIMITED IDE SECTOR NO. 15, KORANGI AMPOULES AMPOULE
LIMITED INDUSTRIAL AREA,
KARACHI-74900
3020 NDA/MAL/H AXA VITACARE AXA-ZOLE F FLUCONAZOL 200 MG AXA PARENTERALS LTD- INDIA PARENTERAL 1.0X100.0 8/28/2019
DP/6576 PARENTERALS LIMITED E PLOT NO. 936, 937 & 939, ORDINARY ML
LTD VILLAGE KISHANPUR, INFUSION BOTTLE
JAMALPUR ROORKEE- VIALS/BOTTL
247667, DIST. HARIDWAR, ES
UTTARAKHAND
3021 NDA/MAL/H UNOSOURCE ABACUS CEFIWEL- CEFIXIME 200MG AKUMS DRUGS & INDIA ORAL SOLID 1.0X10.0X 1/13/2020
DP/6577 PHARMA LTD PHARMA 200 PHARMACEUTICALS LTD..- ORDINARY 10.0
(AFRICA) 19-20,21, SECTOR 6-4, TABLETS TABLET
LIMITED SIDCUL, IIE, RANIPUR BLISTER
HARIDWAR-249403
3022 NDA/MAL/H UNOSOURCE ABACUS PLENCOXIB CELECOXIB 200 MG AKUMS DRUGS & INDIA ORAL SOLID 1.0X6.0X1 8/28/2019
DP/6579 PHARMA LTD. PHARMA 200 PHARMACEUTICALS LTD- ORDINARY 0.0
(AFRICA) PLANT II, PLOT NO. 22, CAPSULES CAPSULE
LIMITED SECTOR- 6A, IIE, SIDCUL, BLISTER
RANIPUR, DISTT.:
HARIDWAR,
UTTARAKHAND
3023 NDA/MAL/H CADILA ABACUS OXEPTAL XCARBAZEPIN 600 MG CADILA HEALTHCARE INDIA ORAL SOLID 1.0X3.0X1 8/28/2019
DP/6580 HEALTHCARE PHARMA 600 E LIMITED -KUNDAIM ORDINARY 0.0
LIMITED (AFRICA) INDUSTRIAL ESTATE,PLOT TABLETS TABLET
GOA, 403115,
3024 NDA/MAL/H CADILA ABACUS ZYDALIS 20 TADALAFIL 20 MG CADILA HEALTH CARE INDIA ORAL SOLID 1.0X4.0 8/28/2019
DP/6581 HEALTHCARE PHARMA LIMITED-KUNDAIM ORDINARY TABLET
LIMITED (AFRICA) INDUSTRIAL ESTATE, TABLETS BLISTER
LIMITED PONDA, GOA-403401,
INDIA.
.
3025 NDA/MAL/H CADILA ABACUS BISOLOL 10 BISOPROLOL 10 MG CADILA HEALTHCARE INDIA ORAL SOLID 1.0X10.0X 8/28/2019
DP/6582 HEALTHCARE PHARMA FUMARATE LIMITED -KUNDAIM ORDINARY 10.0
3026 NDA/MAL/H ZIFAM BOOTS AZIFAM 500 AZITHROMYCI 500 MG FREDUN INDIA ORAL SOLID 1.0X10.0X 8/28/2019
DP/6583 PINNACLE PHARMACEUTIC N PHARMACEUTICALS ORDINARY 10.0
LTD ALS LIMITED LIMITED-14,15,16, CAPSULES CAPSULE
ZORABIAN INDUSTRIAL BLISTER
COMPLEX,VEOOR,PALGHA
R (E), DIST: PALGHAR-401
404
3027 NDA/MAL/H ZIFAM BOOTS ZIFLODIP 5 AMLODIPINE 5 MG FREDUN INDIA ORAL SOLID 1.0X10.0X 8/28/2019
DP/6584 PINNACLE PHARMACEUTIC BESYLATE PHARMACEUTICALS ORDINARY 10.0
LTD ALS LIMITED LIMITED-14,15,16, TABLETS TABLET
404
3028 NDA/MAL/H ZIFAM BOOTS ZIFLODIP 10 AMLODIPINE 10 MG FREDUN INDIA ORAL SOLID 1.0X10.0X 8/28/2019
DP/6585 PINNACLE PHARMACEUTIC BESYLATE PHARMACEUTICALS ORDINARY 10.0
PTY. LTD. ALS LIMITED LIMITED-14,15,16, TABLETS TABLET
404
3029 NDA/MAL/H MSN METRO BREATHEZY- MONTELUKAS 10MG + MSN LABORATORIES (PVT) INDIA ORAL SOLID 1.0X3.0X1 2/4/2019
DP/6598 LABORATORIE PHARMACEUTIC L (10/5) T SODIUM + 5MG LTD-FORMULATIONS ORDINARY 0.0
S PRIVATE ALS LIMITED LEVOCETIRIZI DIVISION-PLOT NO. 42, TABLETS TABLET
LIMITED NE ANRICH INDUSTRIAL BLISTER
DIHYDROCHL ESTATE, BOLLARAM,
ORIDE SANAGAREDDY DISTRICT-
502-325-TELENGANA,
3030 NDA/MAL/H MANKIND TATA UGANDA VOMIKIND ONDANSENT 2MG/ML MANKIND PHARMA LTD-- INDIA PARENTERAL 1.0X4.0X2 7/1/2017
DP/6610 PHARMA LIMITED RON UNIT II VILLAGE ORDINARY .0 ML
LIMITED HYDROCHLOR KISHANPURA P.O AMPOULES AMPOULE
IDE JAMNIWALA TEHSIL
PAONTA SAHIB DISTRICT
SIRMOUR 173 025
HIMACHAL PRADESH
3031 NDA/MAL/H AJANTA ABACUS APRAZOLE OMEPRAZOLE 20MG/6G AJANTA PHARMA LIMITED INDIA ORAL SOLID 1.0X20.0X 7/1/2008
DP/6612 PHARMA PHARMA PLUS-20 + SODIUM + PAITHAN- ORDINARY 6.0 G
LIMITED (AFRICA) BICARBONAT 1680MG/6 MANUFACTURING UNIT B- POWDERS SACHET
LIMITED E G 4/5/6 MIDC PAITHAN
DISTRICT AURANGABAD
431 148 MAHARASTRA
STATE INDIA
3032 NDA/MAL/H MICRO LABS PHILLIPS OLMAT-40 OLMESARTAN 40MG MICRO LABS LTD 92 INDIA ORAL SOLID 1.0X3.0X1 7/1/2017
DP/6613 LIMITED PHARMACEUTIC MEDOXOMIL SIPCOT -92 SIPCOT ORDINARY 0.0
ALS (UGANDA) HOSUR 635 126 TAMIL FILM- TABLET
LIMITED NADU COATED BLISTER
TABLETS
3033 NDA/MAL/H MEDOCHEMIE BOOTS AXETINE CEFUROXIME 1.5MG MEDOCHEMIC LTD-1-10 CYPRUS PARENTERAL 1.0X10.0 7/1/2008
DP/6614 LTD PHARMACEUTIC SODIUM ASTRONAFTON & ORDINARY VIAL
ALS LIMITED CONSTANTINOPOLEOS VIALS CARTON
3505 LIMASSOL
3034 NDA/MAL/H SHIN POONG ESCORTS PYRAMAX PYRONARIDI 180MG + SHIN POONG PHARM. CO., SOUTH ORAL SOLID 1.0X10.0X 7/1/2016
DP/6616 PHARMACEUT PHARMACEUTIC NE 60MG LTD-70, SANDAN-RO, 19 KOREA ORDINARY 9.0
ICALS CO.LTD ALS LIMITED TETRAPHOSP BEON-GIL, DANWON-GU, FILM- TABLET
HATE + ANSAN-SI, GYEONGGI-DO, COATED BLISTER
ARTESUNATE REPUBLIC OF KOREA TABLETS
3035 NDA/MAL/H AJANTA ABACUS APFLU CHLOROPHEN 0.5MG + AJANTA PHARMA LIMITED- INDIA ORAL LIQUID 1.0X100.0 7/1/2009
DP/6617 PHARMA LTD PHARMA ERAMINE + 120MG + 31-0 MIDC INDUSTRIAL ORDINARY ML
(AFRICA) PARACETAM 50MG AREA CHIKALTHANA SYRUPS BOTTLE
LIMITED OL + VITAMIN 431210 DIST
C AURANGABAD
MAHARASHTRA STATE
3036 NDA/MAL/H ESAPHARM BYAMAKA ORANVATE CLOBETASOL 0.05G/100 ESAPHARMA SRL-VIA DE ITALY TOPICAL 1.0X30.0 7/1/2016
DP/6619 SRL PHARMACEUTIC PROPIONATE G GASPERI, 13-20066 MELZO EXTERNAL G TUBE
AL COMPANY (MILAN) ITALY GELS AND
LTD SOLS
3037 NDA/MAL/H MENARINI PHILLIPS NEBILET NEBIVOLOL 5MG BERLIN-CHEMIE AG- GERMANY ORAL SOLID 1.0X14.0 7/1/2016
DP/6620 INTERNATION PHARMACEUTIC 5MG HYDROCHLOR BERLIN-CHEMIE AG ORDINARY TABLET
AL ALS (UGANDA) IDE GLIENICKER WEG 125 D- TABLETS BLISTER,1.
OPERATIONS LIMITED 12489 BERLIN 0X2.0X14.
LUXEMBOUR 0 TABLET
G S.A. BLISTER
3038 NDA/MAL/H MEGA ABACUS BAROLE 20 RABEPRAZOL 20MG INVENTIA HEALTHCARE INDIA ORAL SOLID 1.0X3.0X1 7/1/2011
DP/6621 LIFESCIENCES PHARMA E PVT. LTD .-FI – FI /1 ORDINARY 0.0
(AUSTRALIA) (AFRICA) ADDITIONAL CAPSULES CAPSULE
PTY LTD LIMITED AMBERNATH(EAST) – 421 BLISTER
506,MAHARASHTRA DIST.
THANE, INDIA
3039 NDA/MAL/H UNOSOURCE ABACUS CEFIWEL- CEFIXIME 100MG MALIK LIFESCIENCES INDIA ORAL SOLID 1.0X10.0 7/1/2016
DP/6622 PHARMA LTD. PHARMA 100 DT TRIHYDRATE PRIVATE LIMITED-PLOT ORDINARY TABLET
(AFRICA) NO. 16, NH 58, OTHER BLISTER
LIMITED VARDHMAN INDUTRIAL TABLETS
ESTATE, VILLAGE
BAHADARPUR SAINI
HARIDWAR,
UTTARAKHAND-247667
3040 NDA/MAL/H MENARINI PHILLIPS NEBILET NEBIVOLOL 5MG + BERLIN-CHEMIE AG, SITE GERMANY ORAL SOLID 1.0X2.0X1 7/1/2016
DP/6625 INTERNATION PHARMACEUTIC PLUS 5/12.5 HYDROCHLOR 12.5MG BRITZ (BULK ORDINARY 4.0
AL ALS (UGANDA) IDE + PRODUCTION, -) BERLIN- FILM- TABLET
OPERATIONS LIMITED HYDROCHLOR CHEMIE AG, SITE BRITZ COATED BLISTER
LUXEMBOUR OTHIAZIDE (BULK PRODUCTION, TABLETS
G S.A. BATCH CONTROL)
TEMPELHOFER WEG 83
D-12347 BERLIN
GERMANY
BERLIN-CHEMIE
AG/MENARINI,-
GLIENICKER WEG 125, D-
3041 NDA/MAL/H AUROBINDO GITTOES ONEGABA GABAPENTIN 300MG AUROBINDO PHARMA INDIA ORAL SOLID 1.0X3.0X1 7/1/2010
DP/6626 PHARMA PHARMACEUTIC 300 LIMITED, UNIT – III- ORDINARY 0.0
LIMITED ALS LIMITED SURVEY NO.:113 & CAPSULES CAPSULE
314,BACHUPALLY BLISTER
(VILLAGE)QUTHUBULLAPU
R MANDAL, RANGA REDDY
DISTRICT, TELANGANA
STATE.INDIA.
3042 NDA/MAL/H RECKITT GITTOES STREPSILS MULTI- MULTI- RECKITT BENCKISER THAILAND ORAL SOLID 1.0X24.0 7/1/1997
DP/6627 BENCKISER PHARMACEUTIC HONEY & INGREDIENT INGREDIEN HEALTHCARE ORDINARY LOZENGE
HEALTHCARE ALS LIMITED LEMON T INTERNATIONAL LIMITED- LOZENGES PACK,1.0X
INTERNATION 65 MOO 12,LARD 70.0
AL KRABANG-BANGPLEE LOZENGE
ROAD, BANGPLEE PACK,50.0
SAMUTPRAKARAN 10 540, X2.0
THALAND LOZENGE
BLISTER,2.
0X12.0
LOZENGE
BLISTER
3043 NDA/MAL/H RECKITT GITTOES STREPSILS MULTI- MULTI- RECKITT BENCKISER THAILAND ORAL SOLID 1.0X24.0 7/1/1997
DP/6628 BENCKISER PHARMACEUTIC ORIGINAL INGREDIENT INGREDIEN HEALTHCARE ORDINARY LOZENGE
HEALTHCARE ALS LIMITED T INTERNATIONAL LIMITED- LOZENGES PACK,1.0X
INTERNATION RECKITT BENCKISER 70.0
AL HEALTHCARE LOZENGE
INTERNATIONAL-65 MOO PACK,100.
12,LARD KRABANG- 0X2.0
BANGPLEE ROAD, LOZENGE
BANGPLEE BLISTER,2.
SAMUTPRAKARAN 10 540, 0X12.0
THALAND LOZENGE
BLISTER
3044 NDA/MAL/H MENARINI PHILLIPS NEBILET NEBIVOLOL+ 5MG+25M BERLIN-CHEMIE AG, SITE GERMANY ORAL SOLID 1.0X2.0X1 7/1/2016
DP/6629 INTERNATION PHARMACEUTIC PLUS 5/25 HYDROCHLOR G BRITZ (BULK ORDINARY 4.0
AL ALS (UGANDA) OTHIAZIDE PRODUCTION)- FILM- TABLET
OPERATIONS LIMITED TEMPELHOFER WEG 83 COATED BLISTER,1.
LUXEMBOUR D-12347 BERLIN TABLETS 0X1.0X4.0
G S.A. GERMANY BERLIN- TABLET
CHEMIE AG/MENARINI- BLISTER
GLIENICKER WEG 125, D-
12489 BERLIN
GERMANY(BATCH
RELEASE)
3045 NDA/MAL/H GITTOES GITTOES AGOBURN SILVER 1%W/W AGOG PHARMA LTD-PLOT INDIA TOPICAL 1.0X15.0 7/1/2016
DP/6631 PHARMACEUT PHARMACEUTIC SULFADIAZIN NO.33,SECTOR EXTERNAL G
ICALS LIMITED ALS LIMITED E II,VASAI,TALUKA INDL CO- CREAMS TUBE,1.0X
OP ESTATE LTD,GAURAI 500.0 G
PADA,VASAI(E)DIST.THAN JAR
E INDIA
3046 NDA/MAL/H UMEDICA VITACARE CIPROFLOX CIPROFLOXAC 500MG UMEDICA LABORATORIES INDIA ORAL SOLID 1.0X10.0X 7/1/2006
DP/6632 LABORATORIE LIMITED ACIN IN PVT, VAPI-PLOT 221, GIDC ORDINARY 10.0
S PVT LTD II, VAPI-396195, INDIA TABLETS TABLET
BLISTER
3047 NDA/MAL/H SHELYS BETA COLDRIL PARACETAM 500MG + SHELYS TANZANIA ORAL SOLID 1.0X10.0X 7/1/2010
DP/6633 PHARMACEUT HEALTHCARE OL + 30MG + PHARMACEUTICALS ORDINARY 10.0
ICALS LTD UGANDA CHLORPHENI 2MG LIMITED-PLOT NO. 696, CAPSULES CAPSULE
LIMITED RAMINE BLOCK NO. 32, BLISTER,1.
MALEATE + MIKOCHENI INDUSTRIAL 0X12.0X1.
PSEUDOEPHE AREA, 0X2.0X10.
DRINE HCL NEW BAGAMOYO ROAD, 0
MEWENGE, CAPSULE
DAR ES SALAAM, BLISTER
TANZANIA
BETA HEALTHCARE
INTERNATIONAL LTD - -
3048 NDA/MAL/H UMEDICA VITACARE FIXDEP -120 FEXOFENADI 120MG UMEDICA LABORATORIES INDIA ORAL SOLID 1.0X10.0 7/1/2017
DP/6634 LABORATORIE LIMITED NE PVT, VAPI-PLOT 221, GIDC ORDINARY TABLET
S PVT LTD HYDROCHLOR II, VAPI-396195, INDIA FILM- BLISTER
IDE COATED
TABLETS
3049 NDA/MAL/H MSN METRO COSAMIDE LACOSAMIDE 100MG MSN LABORATORIES LTD- INDIA ORAL SOLID 1.0X10.0 7/1/2013
DP/6636 LABORATORIE PHARMACEUTIC 100 PLOT 42 ANRICH ORDINARY TABLET
PRADESH
3050 NDA/MAL/H MSN METRO COSAMIDE LACOSAMIDE 200MG MSN LABORATORIES LTD- INDIA ORAL SOLID 1.0X10.0 7/1/2016
DP/6637 LABORATORIE PHARMACEUTIC 200 PLOT 42 ANRICH ORDINARY TABLET
PRADESH
3051 NDA/MAL/H MSN METRO COSAMIDE LACOSAMIDE 50MG MSN LABORATORIES PVT. INDIA ORAL SOLID 1.0X10.0 7/1/2016
DP/6638 LABORATORIE PHARMACEUTIC 50 LIMITED-PLOT NO. 42 ORDINARY TABLET
S PRIVATE ALS LIMITED ANRICH INDUSTRIAL FILM- BLISTER
LIMITED ESTATE, BOLLARAM COATED
MEDAK DISTRICT TABLETS
PIN CODE 502 325
3052 NDA/MAL/H MSN ABACUS SAFETELMI TELMISARTA 40MG + MSN LABORATORIES PVT. INDIA ORAL SOLID 1.0X3.0X1 7/1/2017
DP/6640 LABORATORIE PHARMA H ( 40/ N+ 12.5MG LIMITED-PLOT NO. 42 ORDINARY 0.0
S PRIVATE (AFRICA) 12.5) HYDROCHLOR ANRICH INDUSTRIAL LAYERED TABLET
LIMITED LIMITED OTHIAZIDE ESTATE, BOLLARAM TABLETS BLISTER
MEDAK DISTRICT
PIN CODE 502 325
3053 NDA/MAL/H UNOSOURCE ABACUS CEFTRISON CEFTRIAXONE 1.0G + AKUMS DRUGS & INDIA PARENTERAL 1.0X1.5 G 7/1/2016
DP/6641 PHARMA LTD. PHARMA E- S 1.5G SODIUM + 0.5G PHARMACEUTICALS LTD. - ORDINARY VIAL +
(AFRICA) SULBACTAM PLANT III,-PLOT NO. 2, 3, 4 DRY VIALS 10ML WFI
LIMITED SODIUM & 5, SECTOR 6-B, IIE, AMPOULE
3054 NDA/MAL/H MSN ABACUS SAFETELMI TELMISARTA 80MG + MSN LABORATORIES PVT. INDIA ORAL SOLID 1.0X3.0X1 7/1/2017
DP/6645 LABORATORIE PHARMA H ( 80/ N+ 12.5MG LIMITED-PLOT NO. 42 ORDINARY 0.0
S PRIVATE (AFRICA) 12.5) HYDROCHLOR ANRICH INDUSTRIAL LAYERED TABLET
LIMITED LIMITED OTHIAZIDE ESTATE, BOLLARAM TABLETS BLISTER
MEDAK DISTRICT
PIN CODE 502 325
3055 NDA/MAL/H UMEDICA VITACARE DEXAMETH DEXAMETHAS 4MG/ML UMEDICA LABORATORIES INDIA PARENTERAL 2.0 ML 7/1/2016
DP/6648 LABORATORIE LIMITED ASONE ONE SODIUM PVT. LTD-PLOT 221-GIDC, ORDINARY VIAL
S PVT LTD INJECTION PHOSPHATE 2ND PHASE, VAPI 396195 VIALS
GUJARAT
3056 NDA/MAL/H GOOD DAY PLANET CYCLOVEER ACICLOVIR 5%W/W KREMOINT PHARMA PVT INDIA TOPICAL 1.0X10.0 7/1/2016
DP/6651 PHARMACY PHARMACEUTIC LTD-B-8,ADDITIONAL EXTERNAL G TUBE
LIMITED ALS UGANDA AMBERNATH MIDC, CREAMS
LTD AMBERNATH (E),DIST:
THANE 421506, INDIA
3057 NDA/MAL/H CIPLA LTD. QUALITY LAMIVUDIN LAMIVUDINE 300MG+30 CIPLA LTD -MIDC INDIA ORAL SOLID 1.0X30.0 7/1/2017
DP/6652 CHEMICALS LTD - E +TENOFOVIR 0MG PATALGANGA MS 410 220 ORDINARY TABLET
HUMAN +TENOFOVI DISOPROXIL INDIA MFG LIC: 845 FILM- BOTTLE
R FUMARATE COATED
DISOPROXIL TABLETS
FUMARATE
3058 NDA/MAL/H PANACEA VITACARE LIVOLUK LACTULOSE + 10G + PANACEA BIOTEC LTD- INDIA ORAL LIQUID 1.0X90.0 7/1/2016
DP/6654 BIOTEC LTD LIMITED FIBRE ISPAGHULA 3.5G/ 15G MALPUR, BADDI, TEHSIL, ORDINARY G
HUSK NALAGARH, DIST. SOLAN SOLUBLE CONTAIN
(H.P) – 173 205 POWDERS ER
3059 NDA/MAL/H CIPLA LTD. QUALITY ATORLIP-20 ATORVASTATI 20MG CIPLA LTD -MIDC INDIA ORAL SOLID 1.0X3.0X1 7/1/2004
DP/6655 CHEMICALS LTD - N CALCIUM PATALGANGA MS 410 220 ORDINARY 0.0
HUMAN INDIA MFG LIC: 845 TABLETS TABLET
BLISTER
3060 NDA/MAL/H CIPLA LTD. QUALITY METFORMI METFORMIN 500MG CIPLA LTD-MIDC INDIA ORAL SOLID 1.0X10.0X 7/1/2010
DP/6657 CHEMICALS LTD - N HYDROCHLOR PATALGANGA 410 220 ORDINARY 10.0
HUMAN IDE DIST. RAIGAD FILM- TABLET
COATED BLISTER
TABLETS
3061 NDA/MAL/H MSN ABACUS NEBIEM 10 NEBIVOLOL 10MG MSN LABORATORIES PVT. INDIA ORAL SOLID 1.0X3.0X1 7/1/2017
DP/6658 LABORATORIE PHARMA LIMITED-PLOT NO. 42 ORDINARY 0.0
S LTD (AFRICA) ANRICH INDUSTRIAL TABLETS TABLET
LIMITED ESTATE, BOLLARAM BLISTER
MEDAK DISTRICT
PIN CODE 502 325
3062 NDA/MAL/H UGANDA UHMG RESTORS ANHYDROUS 13.5G + FDC LIMITED-WALUJ.- INDIA ORAL LIQUID 1.0X20.5 7/1/2010
DP/6659 HEALTH GOODLIFE GLUCOSE + 2.6G + PLOT B-8, MIDC, ORDINARY G SACHET
MARKETING PHARMACY SODIUM 2.9G + INDUSTRIAL AREA, WALUJ UNIT DOSE
GROUP CHLORIDE + 1.5G 431136 (DIST POWDERS
LIMITED SODIUM AURANGABAD)
CITRATE +
POTASSIUM
CHLORIDE
3063 NDA/MAL/H ELDA REDDYS KETAJEX KETAMINE 50MG/ML CLARIS INJECTABLE INDIA PARENTERAL 1.0X10.0 7/1/2005
DP/6660 INTERNATION PHARMA LIMITED--CHACHARWADI ORDINARY ML VIAL
AL DMCC LIMITED VASANA AHMEDABAD VIALS
GUJARAT
3064 NDA/MAL/H SAKAR ROYAL PHARMA DIAPAM DIAZEPAM 5MG/ML SAKAR HEALTHCARE PVT INDIA PARENTERAL 1.0X2.0X5 7/1/2013
DP/6662 HEALTHCARE 2011 LIMITED LIMITED-PLOT 10/13 ORDINARY .0X2.0 ML
PVT LTD SARKHEJ-BAVLA ROAD, AMPOULES AMPOULE
AHMEDABAD, GUJARAT,
INDIA
3065 NDA/MAL/H PANACEA VITACARE SITCOM EUPHORBIA 10MG/G PANACEA BIOTEC LTD- INDIA TOPICAL 1.0X30.0 7/1/2013
DP/6663 BIOTEC LTD LIMITED PROSTATA MALPUR, BADDI, TEHSIL, EXTERNAL G TUBE
DRY EXTRACT NALAGARH, DIST. SOLAN CREAMS
(H.P) – 173 205
3066 NDA/MAL/H SPARSH BIO- ABACUS SPAMOX AMOXICILLIN 125MG SPARSH BIO-TECH PVT. INDIA ORAL SOLID 1.0X10.0X 7/1/2016
DP/6664 TECH PVT LTD PHARMA 125 KID TRIHYDRATE LIMITED-PLOT NO. ORDINARY 10.0
(AFRICA) 1;SURVEY NO. SOLUBLE TABLET
LIMITED 242/243/244,LAKHABAVA TABLETS BLISTER
D,JAMNAGAR-361 006,
INDIA.
3067 NDA/MAL/H REGAL REGAL PHARMA SALBUMOL SALBUTAMOL 2MG/5ML REGAL KENYA ORAL LIQUID 1.0X100.0 7/1/1997
DP/6665 PHARMACEUI (U) LTD SYRUP PHARMACEUTICALS LTD- ORDINARY ML
CALS LTD BABA DOGO ROAD, SYRUPS BOTTLE
3068 NDA/MAL/H MSN ABACUS NEBIEM 5 NEBIVOLOL 5MG MSN LABORATORIES PVT. INDIA ORAL SOLID 1.0X3.0X1 7/1/2017
DP/6666 LABORATORIE PHARMA HYDROCHLOR LIMITED-PLOT NO. 42 ORDINARY 0.0
S LTD (AFRICA) IDE ANRICH INDUSTRIAL TABLETS TABLET
LIMITED ESTATE, BOLLARAM BLISTER
MEDAK DISTRICT
PIN CODE 502 325
3069 NDA/MAL/H SPARSH BIO- ABACUS SPAMOX AMOXICILLIN 250MG SPARSH BIO-TECH PVT. INDIA ORAL SOLID 1.0X10.0X 7/1/2016
DP/6667 TECH PVT LTD PHARMA 250 DT TRIHYDRATE LIMITED-PLOT NO. ORDINARY 10.0
(AFRICA) 1;SURVEY NO. SOLUBLE TABLET
LIMITED 242/243/244,LAKHABAVA TABLETS STRIP
D,JAMNAGAR-361 006,
INDIA.
3070 NDA/MAL/H UNOSOURCE ABACUS SUPER SILDENAFIL 100MG + AKUMS DRUGS AND INDIA ORAL SOLID 1.0X4.0 7/1/2016
DP/6669 PHARMA LTD. PHARMA WELGRA - CITRATE + 60MG PHARMACEUTICALS LTD- ORDINARY TABLET
(AFRICA) 100 DAPOXETINE PLANT-1 PLOT NO.19, FILM- BLISTER
LIMITED HYDROCHLOR 20&21 SECTOR-6A, 11E, COATED
IDE SIDCUL, RAHIPUR DISTT; TABLETS
HARIDWAR, 249403,
(UTTRAKHAND) INDIA
3071 NDA/MAL/H AFRICURE ROYAL PHARMA METROSIM- METRONIDAZ 200MG AFRICURE INDIA ORAL SOLID 1.0X10.0X 7/1/1997
DP/6670 PHARMACEUT 2011 LIMITED 200 OLE PHARMACEUTICALS ORDINARY 10.0
ICALS (INDIA) (INDIA) PRIVATE LIMITED- TABLETS TABLET
INDIA. CONTAIN
ER
3072 NDA/MAL/H ABACUS ABACUS TRIXONE- CEFTRIAXONE 1000MG + REYOUNG CHINA PARENTERAL 1.0X1.0 7/1/2016
DP/6673 PHARMA LTD PHARMA TZ SODIUM + 125MG PHARMACEUTICAL CO. ORDINARY VIAL
(AFRICA) TAZOBACTAM LTD-NO. 6 ERLANGSHAN DRY VIALS CARTON
SHANDONG 256100
3073 NDA/MAL/H UMEDICA VITACARE UMERAN- DICLOFENAC 75MG/3ML UMEDICA LABORATORIES INDIA PARENTERAL 1.0X1.0X1 7/1/2016
DP/6674 LABORATORIE LIMITED 75 SODIUM PVT. LTD-PLOT 221-GIDC, ORDINARY I 0.0X3.0
S PVT LTD 2ND PHASE, VAPI 396195 M ML
GUJARAT AMPOULES AMPOULE
3074 NDA/MAL/H UNOSOURCE ABACUS UNOSEMID FUROSEMIDE 10MG/ML AKUMS DRUGS & INDIA PARENTERAL 1.0X10.0X 7/1/2016
DP/6675 PHARMA LTD. PHARMA E -10 PHARMACEUTICALS LTD. - ORDINARY 2.0 ML
(AFRICA) PLANT III,-PLOT NO. 2, 3, 4 AMPOULES AMPOULE
LIMITED & 5, SECTOR 6-B, IIE,
3075 NDA/MAL/H BLUE CROSS STAR TUSQ-DX CHLORPHENI 2MG/5ML BLUECROSS INDIA ORAL LIQUID 1.0X1.0X1 7/1/2008
DP/6678 LABORATORIE PHARMACEUTIC RAMINE + LABORATORIES LIMITED-A- ORDINARY 00.0 ML
S LIMITED ALS LTD MALEATE + 15MG/5ML 12,M.I.D.C,NASHIK 422010 SYRUPS BOTTLE
DEXTROMET +
HORPHAN 5MG/5ML
HBR +
PHENYLEPHRI
NE
3076 NDA/MAL/H BLUE CROSS STAR WOMIBAN ALBENDAZOL 400MG BLUE CROSS INDIA ORAL SOLID 1.0X1.0 7/1/1997
DP/6679 LABORATORIE PHARMACEUTIC TABLETS E LABORATORIES LTD-A-12, ORDINARY TABLET
S LIMITED ALS LTD M.I.D.C AMBAD NASHIK- CHEWABLE STRIP
422010 BLUE CROSS TABLETS
LABORATORIES LTD-L-17,
VERNA INDUSTRIAL
ESTATE,VERNA GOA-
403722
3077 NDA/MAL/H PHARMEDIC HEALTHCARE ATELOR ATENOLOL 100MG PHARMEDIC PAKISTAN ORAL SOLID 1.0X20.0 7/1/1997
DP/6680 LABORATORIE LTD. TABLET LABORATORIES (PVT) ORDINARY TABLET
S(PVT) LIMITED-16KM MULTAN TABLETS BLISTER,1
LIMITED ROAD,LAHORE-PAKISTAN 0.0X10.0
TABLET
BLISTER
3078 NDA/MAL/H UNOSOURCE ESCORTS WELQUINE LEVOFLOXACI 0.5%W/V AKUMS DRUGS & INDIA PARENTERAL 1.0X100.0 7/1/2016
DP/6681 PHARMA LTD. PHARMACEUTIC N PHARMACEUTICALS LTD. - ORDINARY ML
ALS LIMITED PLANT III, PLOT NO. 2, 3, 4 INFUSION BOTTLE
& 5, SECTOR 6-B, IIE, VIALS/BOTTL
SIDCUL, RANIPUR, ES
HARIDWAR,
UTTARAKHAND
3079 NDA/MAL/H PHARMEDIC HEALTHCARE BENDA 200 ALBENDAZOL 100MG/5 PHARMEDIC PAKISTAN ORAL LIQUID 1.0X10.0 7/1/1998
DP/6683 LABORATORIE LTD. DRY E ML LABORATORIES (PVT) ORDINARY ML
S(PVT) SUSPENSIO LIMITED-16KM MULTAN DRY BOTTLE
LIMITED N ROAD,LAHORE-PAKISTAN SUSPENSION
S/SYRUPS/D
ROPS
3080 NDA/MAL/H NEON AIVEEN (U) EVACEF CEFOTAXIME 1 G NEON LABORATORIES LTD- INDIA PARENTERAL 1.0X1.0 G 7/1/2014
DP/6685 LABARATORIE LIMITED PLOT NO. 29-32, 57 & 60, ORDINARY VIAL
S LTD PALGHAR TALUKA CO- DRY VIALS
OPERATIVE ESTATE ,
BOISAR ROAD
3081 NDA/MAL/H DAWA SUPER MEDIC DAWASOLO PREDNISOLO 5MG DAWA LTD -PLOT KENYA ORAL SOLID 1.0X1000. 7/1/2010
DP/6686 LIMITED LTD NE NE NO.7879/8 BABA ROAD ORDINARY 0 TABLET
RUARAKA NAIROBI TABLETS CONTAIN
ER,1.0X10
.0X10.0
TABLET
BLISTER
3082 NDA/MAL/H NITIN HEALTHCARE CAREOCEF CEFTRIAXONE 1G NITIN LIFESCIENCES LTD..- INDIA PARENTERAL 1.0X50.0X 7/1/2016
DP/6688 LIFESCIENCES LTD. SODIUM RAMPUR GHAT ROAD, ORDINARY 1.0 G VIAL
LTD PAOMTA SAHIB DIST. VIALS
SIRMOUR H.
3083 NDA/MAL/H DAWA SUPER MEDIC EFLARON METRONIDAZ 200MG DAWA LTD -PLOT KENYA ORAL SOLID 1.0X1000. 7/1/1997
DP/6689 LIMITED LTD OLE NO.7879/8 BABA ROAD ORDINARY 0 TABLET
RUARAKA NAIROBI TABLETS CONTAIN
ER
3084 NDA/MAL/H NOVARTIS SURGIPHARM CERTICAN1 EVEROLIMUS 1MG NOVARTIS PHARMA STEIN SWITZERLAN ORAL SOLID 1.0X6.0X1 7/1/2016
DP/6693 PHARMA (U) LIMITED AG.-SCHAFF HAUSER D ORDINARY 0.0
SERVICES INC STRASSE 4332, STEIN - SOLUBLE TABLET
SWITZERLAND TABLETS BLISTER
3085 NDA/MAL/H NOVARTIS SURGIPHARM CERTICAN EVEROLIMUS 0.5MG NOVARTIS PHARMA STEIN SWITZERLAN ORAL SOLID 1.0X6.0X1 7/1/2016
DP/6694 PHARMA (U) LIMITED 0.5 AG.-SCHAFF HAUSER D ORDINARY 0.0
SERVICES INC. STRASSE 4332, STEIN - TABLETS TABLET
SWITZERLAND BLISTER
3086 NDA/MAL/H CACHET ASTRA PHARMA ARTIMED DICLOFENAC 50MG CACHET INDIA ORAL SOLID 1.0X10.0X 7/1/2009
DP/6700 PHAMACUITIC (U) LIMITED SODIUM PHARMACEUTICALS PVT ORDINARY 10.0
ALS PVT LTD LTD -THANA BADDI ENTERIC- TABLET
173205 DISTRICT SOLAN COATED BLISTER
(HIMACHAL PRADESH) TABLETS
INDIA
3087 NDA/MAL/H CACHET ASTRA PHARMA CACH-ART ARTEMETHER 80MG/ CACHET INDIA ORAL SOLID 1.0X6.0 7/1/2011
DP/6701 PHARMACEUT (U) LIMITED DS / 480MG PHARMACEUTICALS PVT ORDINARY TABLET
ICALS PVT LTD LUMEFANTRI LTD-VILLAGE AND POST FILM- BLISTER
NE THANA BADDI TEHSIL COATED
NALAGARH SOLAN TABLETS
DISTRICT HIMACHAL
PRADESH 173 205
3088 NDA/MAL/H CACHET ASTRA PHARMA CACHCOLD PARACETAM 500MG/ CACHET INDIA ORAL SOLID 1.0X50.0X 7/1/2011
DP/6703 PHARMACEUT (U) LIMITED PLUS OL/ 30MG/ PHARMACEUTICALS PVT ORDINARY 4.0
ICALS PVT LTD CAFFEINE/ 5MG/ 2MG LTD -THANA BADDI TABLETS TABLET
PHENYLEPHRI 173205 DISTRICT SOLAN STRIP
NE/ (HIMACHAL PRADESH)
CHLORPHENI INDIA
RAMINE
3089 NDA/MAL/H CACHET ASTRA PHARMA CACHEWOR MEBENDAZOL 100MG CACHET INDIA ORAL SOLID 1.0X10.0X 7/1/2010
DP/6705 PHARMACEUT (U) LIMITED M E PHARMACEUTICALS PVT ORDINARY 10.0
ICALS PVT LTD LTD -THANA BADDI CHEWABLE TABLET
173205 DISTRICT SOLAN TABLETS BLISTER,1.
(HIMACHAL PRADESH) 0X1000.0
INDIA TABLET
CONTAIN
ER
3090 NDA/MAL/H CACHET ASTRA PHARMA CACH-E- MEBENDAZOL 100MG/5 CACHET INDIA ORAL LIQUID 1.0X30.0 7/1/2009
DP/6706 PHARMACEUT (U) LIMITED WORM E ML PHARMACEUTICALS PVT ORDINARY ML
ICALS PVT LTD LTD -THANA BADDI SUSPENSION BOTTLE
173205 DISTRICT SOLAN S
(HIMACHAL PRADESH)
INDIA
3091 NDA/MAL/H PHARMEDIC HEALTHCARE CLOMINOL CLOMIPHENE 50MG PHARMEDIC LAB (PVT) PAKISTAN ORAL SOLID 1.0X10.0 7/1/1997
DP/6708 LABORATORIE LTD. TABLETS LTD-# 4263, 16KM ORDINARY TABLET
S(PVT) MULTAN RD, LAHORE TABLETS BLISTER
LIMITED PAKISTAN
3092 NDA/MAL/H CACHET ASTRA PHARMA CACHPAR PARACETAM 500MG CACHET INDIA ORAL SOLID 1.0X10.0X 7/1/2012
DP/6709 PHARMACEUT (U) LIMITED OL PHARMACEUTICALS PVT ORDINARY 10.0
ICALS PVT LTD LTD-VILLAGE AND POST TABLETS TABLET
THANA BADDI TEHSIL BLISTER,1.
NALAGARH SOLAN 0X1000.0
DISTRICT HIMACHAL TABLET
PRADESH 173 205 CONTAIN
ER
3093 NDA/MAL/H PHARMEDIC HEALTHCARE DIABIN METFORMIN 500MG PHARMEDIC LAB (PVT) PAKISTAN ORAL SOLID 1.0X10.0X 7/1/1997
DP/6710 LABORATORIE LTD. TABLETS LTD-# 4263, 16KM ORDINARY 10.0
S(PVT) MULTAN RD, LAHORE TABLETS TABLET
LIMITED PAKISTAN BLISTER
3094 NDA/MAL/H CACHET ASTRA PHARMA CACHPAR PARACETAM 125MG/5 CACHET INDIA ORAL LIQUID 1.0X60.0 7/1/2009
DP/6711 PHARMACEUT (U) LIMITED OL ML PHARMACEUTICALS PVT ORDINARY ML
ICALS PVT LTD LTD -THANA BADDI SUSPENSION BOTTLE,1.
173205 DISTRICT SOLAN S 0X100.0
(HIMACHAL PRADESH) ML
INDIA BOTTLE
3095 NDA/MAL/H CACHET ASTRA PHARMA CACID-O OMEPRAZOLE 20MG CACHET INDIA ORAL SOLID 1.0X10.0X 7/1/2011
DP/6712 PHARMACEUT (U) LIMITED PHARMACEUTICALS PVT ORDINARY 10.0
ICALS PVT LTD LTD -THANA BADDI CAPSULES CAPSULE
173205 DISTRICT SOLAN STRIP
(HIMACHAL PRADESH)
INDIA
3096 NDA/MAL/H CACHET ASTRA PHARMA CAMET METOCLOPRA 10MG CACHET INDIA ORAL SOLID 1.0X10.0X 7/1/2009
DP/6713 PHARMACEUT (U) LIMITED MIDE PHARMACEUTICALS PVT ORDINARY 10.0
ICALS PVT LTD HYDROCHLOR LTD -THANA BADDI TABLETS TABLET
IDE 173205 DISTRICT SOLAN BLISTER
(HIMACHAL PRADESH)
INDIA
3097 NDA/MAL/H CACHET ASTRA PHARMA CAZITHRO AZITHROMYCI 200MG/5 CACHET INDIA ORAL LIQUID 1.0X1.0X1 7/1/2009
DP/6715 PHARMACEUT (U) LIMITED N ML PHARMACEUTICALS PVT ORDINARY 5.0 ML
ICALS PVT LTD LTD -THANA BADDI SUSPENSION BOTTLE
173205 DISTRICT SOLAN S
(HIMACHAL PRADESH)
INDIA
3098 NDA/MAL/H NOVARTIS SURGIPHARM CATAFLAM DICLOFENAC 50MG CATALENT GERMANY GERMANY ORAL SOLID 1.0X10.0 7/1/2016
DP/6716 PHARMA (U) LIMITED 50 POTASSIUM EBERBACH GMBH..- ORDINARY CAPSULE
SERVICES INC GAMMELS OTHER BLISTER,1.
BACHERSTRASSE2 CAPSULES 0X20.0
CAPSULE
BLISTER
3099 NDA/MAL/H CACHET ASTRA PHARMA CAZITHRO AZITHROMYCI 500MG CACHET INDIA ORAL SOLID 1.0X1.0X3 7/1/2011
DP/6717 PHARMACEUT (U) LIMITED N PHARMACEUTICALS PVT ORDINARY .0 TABLET
ICALS PVT LTD LTD -THANA BADDI TABLETS BLISTER
173205 DISTRICT SOLAN
(HIMACHAL PRADESH)
INDIA
3100 NDA/MAL/H PHARMEDIC HEALTHCARE NAPROX- NAPROXEN 500MG PHARMEDIC LAB (PVT) PAKISTAN ORAL SOLID 1.0X2.0X1 7/1/2003
DP/6719 LABORATORIE LTD. 500 SODIUM LTD-# 4263, 16KM ORDINARY 0.0
S(PVT) MULTAN RD, LAHORE TABLETS TABLET
3101 NDA/MAL/H SANDOZ SURGIPHARM COLESTOP ATORVASTATI 20MG LEK PHARMACEUTICALS- SLOVENIA ORAL SOLID 1.0X3.0X1 7/1/2016
DP/6720 KENYA C/O (U) LIMITED N D.D VEROVŠKOVA 57, ORDINARY 0.0
NOVARTIS 1526 LJUBLJANA FILM- TABLET
PHARMA SLOVENIA COATED BLISTER
3102 NDA/MAL/H SANDOZ SURGIPHARM PANOPRIST PERINDOPRIL 2MG+0.62 LEK PHARMACEUTICALS- SLOVENIA ORAL SOLID 1.0X3.0X1 7/1/2016
DP/6721 KENYA C/O (U) LIMITED PLUS ERBUMINE+ 5MG D.D VEROVŠKOVA 57, ORDINARY 0.0
NOVARTIS 2/0.625 INDAPAMIDE 1526 LJUBLJANA TABLETS TABLET
PHARMA SLOVENIA BLISTER
SERVICES INC
3103 NDA/MAL/H MEGA ABACUS CILZEC 40 TELMISARTA 40MG MSN LABORATORIES PVT. INDIA ORAL SOLID 1.0X3.0X1 7/1/2016
DP/6722 LIFESCIENCES PHARMA N LIMITED-PLOT NO. 42 ORDINARY 0.0
(AUSTRALIA) (AFRICA) ANRICH INDUSTRIAL TABLETS TABLET
PTY LTD LIMITED ESTATE, BOLLARAM BLISTER
MEDAK DISTRICT
PIN CODE 502 325
3104 NDA/MAL/H PHARMEDIC HEALTHCARE TRADOL TRAMADOL 100MG/2 PHARMEDIC LAB (PVT) PAKISTAN PARENTERAL 1.0X1.0X5 7/1/2007
DP/6723 LABORATORIE LTD. INJECTION HCL ML LTD-# 4263, 16KM ORDINARY .0 ML
S(PVT) MULTAN RD, LAHORE AMPOULES AMPOULE
LIMITED PAKISTAN
3105 NDA/MAL/H MEGA ABACUS CILZEC 80 TELMISARTA 80MG MSN LABORATORIES PVT. INDIA ORAL SOLID 1.0X3.0X1 7/1/2016
DP/6724 LIFESCIENCES PHARMA N LIMITED-PLOT NO. 42 ORDINARY 0.0
(AUSTRALIA) (AFRICA) ANRICH INDUSTRIAL TABLETS TABLET
PTY LTD LIMITED ESTATE, BOLLARAM BLISTER
MEDAK DISTRICT
PIN CODE 502 325
3106 NDA/MAL/H SANDOZ SURGIPHARM PANOPRIST PERINDOPRIL 4MG + LEK PHARMACEUTICALS- SLOVENIA ORAL SOLID 1.0X3.0X1 7/1/2016
DP/6725 KENYA C/O (U) LIMITED PLUS 4/1.25 ERBUMINE + 1.25MG D.D VEROVŠKOVA 57, ORDINARY 0.0
NOVARTIS INDAPAMIDE 1526 LJUBLJANA TABLETS TABLET
PHARMA SLOVENIA BLISTER
SERVICES INC
3107 NDA/MAL/H PHARMEDIC HEALTHCARE ZYNOL- ALLOPURINOL 300MG PHARMEDIC LAB (PVT) PAKISTAN ORAL SOLID 1.0X10.0X 7/1/1997
DP/6727 LABORATORIE LTD. 300MG LTD-# 4263, 16KM ORDINARY 10.0
S(PVT) TABLET MULTAN RD, LAHORE TABLETS TABLET
3108 NDA/MAL/H COSMOS LTD ASTRA PHARMA CIPROCOS- CIPROFLOXAC 500MG COSMOS LTD.-RANGWE KENYA ORAL SOLID 1.0X10.0 7/1/2000
DP/6728 (U) LIMITED 500 IN ROAD; OFF LUNGA LUNGA ORDINARY TABLET
TABLETS ROAD. P.O BOX 414 33, FILM- BLISTER,1
NAIROBI COATED 0.0X10.0
TABLETS TABLET
BLISTER
3109 NDA/MAL/H COSMOS LTD ASTRA PHARMA COSCOF 'C' MULTI- MULTI- COSMOS LTD.-RANGWE KENYA ORAL LIQUID 1.0X100.0 7/1/2010
DP/6729 (U) LIMITED LINCTUS INGREDIENT INGREDIEN ROAD; OFF LUNGA LUNGA ORDINARY ML
T ROAD. P.O BOX 414 33, SYRUPS BOTTLE,1.
NAIROBI 0X60.0 ML
BOTTLE
3110 NDA/MAL/H PHARMEDIC HEALTHCARE CEFOTRIM- CEFTRIAXONE 1000MG PHARMEDIC LAB (PVT) PAKISTAN PARENTERAL 1.0X1000. 7/1/2006
DP/6730 LABORATORIE LTD. 1000 LTD-# 4263, 16KM ORDINARY 0 MG VIAL
S(PVT) MULTAN RD, LAHORE DRY VIALS + 5 ML
LIMITED PAKISTAN AMPOULE
OF
WATER
FOR
INJECTIO
N
3111 NDA/MAL/H COSMOS LTD ASTRA PHARMA COSCOF MULTI- MULTI- COSMOS LTD.-RANGWE KENYA ORAL LIQUID 1.0X60.0 7/1/2010
DP/6732 (U) LIMITED EXPECTORA INGREDIENT INGREDIEN ROAD; OFF LUNGA LUNGA ORDINARY ML
NT T ROAD. P.O BOX 414 33, SYRUPS BOTTLE,1.
ORIGINAL NAIROBI 0X100.0
ML
BOTTLE
3112 NDA/MAL/H CACHET ASTRA PHARMA EASCOF BROMHEXIDI 24MG/100 CACHET INDIA ORAL LIQUID 1.0X100.0 7/1/2009
DP/6734 PHARMACEUT (U) LIMITED NE HCL + ML + PHARMACEUTICALS PVT ORDINARY ML
ICALS PVT LTD SALBUTAMOL 42MG/100 LTD -THANA BADDI SYRUPS BOTTLE
SULPHATE + ML + 173205 DISTRICT SOLAN
GUAIPHENESI 1G/ML (HIMACHAL PRADESH)
N INDIA
3113 NDA/MAL/H NOVARTIS SURGIPHARM SANDOSTA OCTREOTIDE 0.05MG NOVARTIS PHARMA STEIN SWITZERLAN PARENTERAL 1.0X5.0X1 7/1/2016
DP/6736 PHARMA (U) LIMITED TIN ACETATE AG.-SCHAFF HAUSER D ORDINARY .0 ML
SERVICES INC STRASSE 4332, STEIN - AMPOULES AMPOULE
SWITZERLAND
3114 NDA/MAL/H CACHET ASTRA PHARMA ESENVIT GLYCERIN/ 5.0G/ CACHET INDIA ORAL LIQUID 1.0X60.0 7/1/2008
DP/6737 PHARMACEUT (U) LIMITED ZINC 263.83MG/ PHARMACEUTICALSPVT.LT ORDINARY ML
ICALS PVT LTD SULPHATE/ 0.4035MG/ D.--415,SHAH SYRUPS BOTTLE,1.
SODIUM 57.66MG/ NAHAR,WORLI 0X100.0
MOLYBDATE/ 612MG MUMBAI ML
MANGANESE BOTTLE
CHLORIDE/
LYSINE HCL
3115 NDA/MAL/H NVS KENYA SURGIPHARM ULTIBRO INDACATERO 110MCG+5 NOVARTIS PHARMA STEIN SWITZERLAN LUNG 1.0X30.0 7/1/2016
DP/6741 LTD (U) LIMITED BREEZHALE L 0MCG AG.-SCHAFF HAUSER D ADMINISTRA CAPSULE
R MALEATE+GL STRASSE 4332, STEIN - TION BLISTER
YCOPYRRONI SWITZERLAND INHALER
UM BROMIDE CAPSULES
3116 NDA/MAL/H M.J.BIOPHAR TATA UGANDA CEFTRIAXO CEFTRIAXONE 1G M.J.BIOPHARM PVT LTD-L- INDIA PARENTERAL 1.0X1.0 G 7/1/2004
DP/6744 M PVT LTD LIMITED NE FOR 7 MIDC INDUSTRIAL AREA ORDINARY VIAL
INJECTION TALOYA NAVI MUMBAI DRY VIALS
3117 NDA/MAL/H KOPRAN LTD TATA UGANDA FLUPEN- FLUCLOXACIL 250MG KOPRAN LTD-VILLAGE INDIA ORAL SOLID 1.0X10.0X 7/1/2016
DP/6746 LIMITED 250 LIN SODIUM SAVROLI TAL KHARAPUR ORDINARY 10.0
DIST RAIGAD 410 202 CAPSULES CAPSULE
BLISTER
3118 NDA/MAL/H KAMPALA KAMPALA NYTIN NYSTATIN 500,000IU KAMPALA UGANDA ORAL SOLID 1.0X100.0 7/1/2005
DP/6750 PHARMACEUT PHARMACEUTIC PHARMECEUTICALS ORDINARY TABLET
ICAL AL INDUSTRIES INDUSTRIES LTD.-PLOT TABLETS CONTAIN
INDUSTRIES 1996 LIMITED M444B STRETCHER RD, ER
3119 NDA/MAL/H INDOCO STAR METCHEK METFORMIN 850MG INDOCO REMEDIES LTD-B- INDIA ORAL SOLID 1.0X3.0X1 7/1/2010
DP/6751 REMEDIES PHARMACEUTIC 850 20, MIDC, WALUJ, ORDINARY 0.0
LIMITED ALS LTD AURANGABAB 431136 FILM- TABLET
INDIA COATED BLISTER
TABLETS
3120 NDA/MAL/H KAMPALA KAMPALA VITACEE ASCORBIC 100MG KAMPALA UGANDA ORAL SOLID 1.0X1000. 7/1/2000
DP/6752 PHARMACEUT PHARMACEUTIC ACID PHARMACEUTICAL ORDINARY 0 TABLET
ICAL AL INDUSTRIES INDUSTRIES (1996) CHEWABLE CONTAIN
INDUSTRIES 1996 LIMITED LIMITED - -STRETCHER TABLETS ER,1.0X10
(1996) LTD ROAD PLOT M444B .0X10.0
BLISTER
3121 NDA/MAL/H BLUE CROSS STAR TUSQ X TERBUTALINE 1.25MG+4 BLUECROSS INDIA ORAL LIQUID 1.0X100.0 7/1/2001
DP/6753 LABARATORIE PHARMACEUTIC SYRUP +BROMHEXIN MG+50MG LABORATORIES LIMITED-A- ORDINARY ML
S LIMITED ALS LTD E+GUAIFENES /5ML 12,M.I.D.C,NASHIK 422010 SYRUPS BOTTLE
IN
3122 NDA/MAL/H INDIAN TATA UGANDA ABHAYRAB RABIES >2.5 I.U HUMAN BIOLOGICALS INDIA PARENTERAL 1.0X2.5 7/1/2016
DP/6754 IMMUNOLOGI LIMITED ANTIGEN PER VIAL INSTITUTE ( A DIVISION OF ORDINARY I.U VIAL
CALS LIMITED DERIVED INDIAN DRY VIALS 1*0.5ML
FROM RABIES IMMUNOLOGICALS LTD) .- DILUENT(
VIRUS(L.PAST KOZHIPANNAI 0.9%W/V
EUR PUDUMUND P.O DR. SODIUM
2061/VERO BASAVAIAH NAGAR CHLORIDE
STRAIN) UDHAGAMANDALAM PIN: INJ. B.P) -
643007 TAMIL NADU 1 DOSE
VIAL
3123 NDA/MAL/H INDOCO STAR FLAMAR METHYL 1%W/W+5 INDOCO REMEDIES LTD - 0- INDIA TOPICAL 1.0X20.0 7/1/2004
DP/6755 REMEDIES PHARMACEUTIC NICOTINATE+ %W/W+8% .L-14 VERNA INDUSTRIAL EXTERNAL G TUBE
LIMITED ALS LTD MEPHENESIN W/W+2% AREA, VERNA, GOA- CREAMS
+METHYL W/W 403722
SALICYLATE+
MENTHOL
3124 NDA/MAL/H BETA BETA FEVEREX PARACETAM 120MG/5 BETA HEALTHCARE KENYA ORAL LIQUID 1.0X60.0 7/1/2007
DP/6756 HEALTHCARE HEALTHCARE TOTO OL ML INTERNATIONAL LTD - - ORDINARY ML
UGANDA UGANDA SUSPENSIO PLOT SUSPENSION BOTTLE
LIMITED LIMITED N NO.209/6554,MOGADISHU S
INDUSTRIAL AREA,
P.O.BOX 42569-001000
NAIROBI,KENYA
3125 NDA/MAL/H ADCOCK UGANDA ADCO- PARACETAM 500MG ADCOCK INGRAM LIMITED INDIA ORAL SOLID 1.0X2.0X1 7/1/2016
DP/6758 INGRAM HEALTH NAPAMOL OL -49C & D BOMMASANDRA ORDINARY 0.0
LIMITED MARKETING INDUSTRIAL AREA ANEKAL TABLETS TABLET
GROUP LIMITED TALUK, BANGALORE BLISTER
560099, KARNATAKA
STATE, INDIA
3126 NDA/MAL/H ADCOCK UGANDA BETAPYN PARACETAM 450 ADCOCK INGRAM LIMITED INDIA ORAL SOLID 2.0X9.0 7/1/1999
DP/6759 INGRAM HEALTH OL+CODEINE MG+10 -49C & D BOMMASANDRA ORDINARY TABLET
LIMITED MARKETING PHOSPHATE+ MG+5 INDUSTRIAL AREA ANEKAL TABLETS BLISTER,6.
GROUP LIMITED DOXYLAMINE MG+50 TALUK, BANGALORE 0X9.0
+CAFFEINE MG TABLET
560099, KARNATAKA BLISTER,1.
STATE, INDIA 0X1.0X9.0
TABLET
BLISTER
3127 NDA/MAL/H ADCOCK UGANDA DAWANOL PARACETAM 200MG+30 ADCOCK INGRAM LIMITED KENYA ORAL SOLID 1.0X100.0 7/1/1997
DP/6761 INGRAM HEALTH TABLETS OL+ACETYLSA 0MG+30M -49C & D BOMMASANDRA ORDINARY TABLET
LIMITED MARKETING LICYLIC G INDUSTRIAL AREA ANEKAL TABLETS CARTON
GROUP LIMITED ACID+CAFFEI TALUK, BANGALORE
NE
560099, KARNATAKA
STATE, INDIA
DAR AL DAWA-NA’UR –
PRINCE HASHEM BIN AL-
HUSSEIN STREET P.O. BOX
9364 AMMAN 11191
JORDAN
3128 NDA/MAL/H COSMOS LTD ASTRA PHARMA FLUCOLD MULTIINGRE NA COSMOS LTD.-RANGWE KENYA ORAL SOLID 1.0X10.0X 7/1/1998
DP/6762 (U) LIMITED CAPSULES DIENT ROAD; OFF LUNGA LUNGA ORDINARY 10.0
ROAD. P.O BOX 414 33, CAPSULES CAPSULE
NAIROBI BLISTER
3129 NDA/MAL/H ADCOCK UGANDA COMPRAL PARACETAM 100MG+40 ADCOCK INGRAM LIMITED INDIA ORAL SOLID 1.0X48.0X 7/1/2005
DP/6763 INGRAM HEALTH HEADACHE OL+ASPIRIN+ 0MG+130 -49C & D BOMMASANDRA ORDINARY 2.0
LIMITED MARKETING TABLETS CAFFEINE MG INDUSTRIAL AREA ANEKAL TABLETS TABLET
GROUP LIMITED ANHYDROUS TALUK, BANGALORE STRIP
560099, KARNATAKA
STATE, INDIA
3130 NDA/MAL/H UNICHEM EUROPA IZRA 40 ESOMEPRAZO 40MG UNICHEM LABORATORIES INDIA ORAL SOLID 1.0X10.0 7/1/2016
DP/6764 LABORATORIE HEALTHCARE LE LTD-UNIT II, VILLAGE ORDINARY TABLET
S LTD (U) LTD MAGNESIUM BHATAULI KALAN, BADDI ENTERIC- STRIP
TRIHYDRATE SOLAN (HP) 173205 COATED
TABLETS
3131 NDA/MAL/H CACHET ASTRA PHARMA IBUCACH IBUPROFEN 200MG CACHET INDIA ORAL SOLID 1.0X10.0X 7/1/2010
DP/6765 PHARMACEUT (U) LIMITED 200 PHARMACEUTICALS PVT ORDINARY 10.0
ICALS PVT LTD LTD -THANA BADDI TABLETS TABLET
173205 DISTRICT SOLAN BLISTER,1.
(HIMACHAL PRADESH) 0X1000.0
INDIA TABLET
CONTAIN
ER
3132 NDA/MAL/H ADCOCK UGANDA LOCAINE A LIDOCAINE 21.33MG/1 PHARMA-Q (PTY) LTD -50 SOUTH PARENTERAL 1.0X100.0 7/1/2004
DP/6766 INGRAM HEALTH HYDROCHLOR .8ML + COMMANDO ROAD AFRICA ORDINARY X1.8 ML
LIMITED MARKETING IDE+ADRENAL 0.025MG/1 INDUSTRIAL WEST, SPAIN CARTRIDGES CARTRIDG
GROUP LIMITED INE .8ML JOHANNESBURG E
LABORATORIOS INIBSA S.A-
CTRA. SABADELL-
GRANOLLERS, KM. 14,5
08185 LLICA DE VALL
3133 NDA/MAL/H ADCOCK UGANDA MEDI-KEEL BENZOCAINE 12MG+1.5 UNIQUE INDIA ORAL SOLID 1.0X2.0X8 7/1/2016
DP/6767 INGRAM HEALTH A +CETYLPYRIDI MG PHARMACEUTICALS ORDINARY .0
LIMITED MARKETING NIUM LABORATORIES-SURVEY LOZENGES LOZENGE
GROUP LIMITED CHLORIDE NO. 101/2 AND 102/1, BLISTER
DAMAN INDUSTRIAL
ESTATE, AIRPORT ROAD,
KADAIYA, DAMAN – 396
210 INDIA
DP/6768 INGRAM HEALTH A +CETYLPYRIDI MG PHARMACEUTICALS ORDINARY .0
LIMITED MARKETING BLACKCURR NIUM LABORATORIES-SURVEY LOZENGES LOZENGE
GROUP LIMITED ANT CHLORIDE NO. 101/2 AND 102/1, BLISTER
DAMAN INDUSTRIAL
210 INDIA
DP/6769 INGRAM HEALTH A HONEY & +CETYLPYRIDI MG PHARMACEUTICALS ORDINARY .0
LIMITED MARKETING LEMON NIUM LABORATORIES-SURVEY LOZENGES LOZENGE
GROUP LIMITED CHLORIDE NO. 101/2 AND 102/1, BLISTER
DAMAN INDUSTRIAL
210 INDIA
3136 NDA/MAL/H HOVID BHD UNITED DIFLUVID FLUCONAZOL 150MG HOVID BHD -121 ,JALAN MALAYSIA ORAL SOLID 1.0X4.0 7/1/2016
DP/6771 HEALTHCARE E TUNKU ABDUL RAHMAN , ORDINARY CAPSULE
DISTRIBUTORS 30010 IPOH , PERAK , CAPSULES BLISTER
LTD MALAYSIA
3137 NDA/MAL/H ARISTO NORVIK PIOSAFE 30 PIOGLITAZON 30MG ARISTO INDIA ORAL SOLID 1.0X3.0X1 7/1/2007
DP/6772 PHARMACEUT ENTERPRISES E HCL PHARMACEUTICALS PVT ORDINARY 0.0
ICALS PVT LTD LIMITED LTD -PLOT NO 208 NEW TABLETS TABLET
INDUSTRIAL GREEN NO2 BLISTER
MANDIDEED 462046
3138 NDA/MAL/H KOTRA ABACUS AXCEL DIPHENHYDR 12.5MG+1 KOTRA PHARMA (M) SDN. MALAYSIA ORAL LIQUID 1.0X90.0 7/1/2008
DP/6774 PHARMA (M) PHARMA FLEMIN AMINE 30MG/5ML BHD-1 JALAN TTC 12, ORDINARY ML
SDN,BHD (AFRICA) EXPECTORA HYDROCHLOR CHENG INDUSTRIAL SYRUPS BOTTLE,1.
LIMITED NT IDE ESTATE, 75250 MELAKA 0X100.0
+AMMONIU MALYSIA ML
M CHLORIDE BOTTLE
3139 NDA/MAL/H LINCOLN METRO M-FORLIN METFORMIN 500MG LINCOLN INDIA ORAL SOLID 1.0X10.0X 7/1/2010
DP/6776 PHARMACEUT PHARMACEUTIC 500 PHARMACEUTICAL ORDINARY 10.0
INDIA
3140 NDA/MAL/H KOTRA ABACUS AXCEL FUSIDIC ACID 2%W/W KOTRA PHARMA (M) SDN. MALAYSIA TOPICAL 1.0X5.0 G 7/1/2016
DP/6777 PHARMA (M) PHARMA FUSIDIC BHD-1 JALAN TTC 12, EXTERNAL TUBE,1.0X
SDN,BHD (AFRICA) ACID CHENG INDUSTRIAL CREAMS 15.0 G
LIMITED ESTATE, 75250 MELAKA TUBE
MALYSIA
3141 NDA/MAL/H KOTRA ABACUS AXCEL IBUPROFEN 100MG/5 KOTRA PHARMA (M) SDN. MALAYSIA ORAL LIQUID 1.0X60.0 7/1/2016
DP/6778 PHARMA (M) PHARMA IBUPROFEN ML BHD-1 JALAN TTC 12, ORDINARY ML
SDN,BHD (AFRICA) CHENG INDUSTRIAL SYRUPS BOTTLE
MALYSIA
3142 NDA/MAL/H IND SWIFT PLANET NETAZOX- NITAZOXANID 500MG IND-SWIFT LIMITED- INDIA ORAL SOLID 1.0X10.0X 7/1/2007
DP/6781 LIMITED PHARMACEUTIC 500 E INDUSTRIAL GROWTH ORDINARY 1.0X6.0
ALS UGANDA CENTRE, PHASE I, SAMBA FILM- TABLET
LTD (JAMMU), J&K 184121, COATED BLISTER
INDIA TABLETS
3143 NDA/MAL/H IND SWIFT PLANET NETAZOX NITAZOXANID 200MG IND-SWIFT LIMITED- INDIA ORAL SOLID 1.0X10.0X 7/1/2008
DP/6785 LIMITED PHARMACEUTIC DT E INDUSTRIAL GROWTH ORDINARY 1.0X6.0
ALS UGANDA CENTRE, PHASE I, SAMBA ORALLY TABLET
LTD (JAMMU), J&K 184121, DISINTEGRA BLISTER
INDIA TING
TABLETS
3144 NDA/MAL/H IND SWIFT PLANET NETAZOX NITAZOXANID 100MG/5 IND-SWIFT LIMITED- INDIA ORAL LIQUID 1.0X30.0 7/1/2008
DP/6787 LIMITED PHARMACEUTIC E ML INDUSTRIAL GROWTH ORDINARY ML
ALS UGANDA CENTRE, PHASE I, SAMBA DRY BOTTLE
LTD (JAMMU), J&K 184121, SUSPENSION
INDIA S/SYRUPS/D
ROPS
3145 NDA/MAL/H SOUTH EGYPT WIDE ROYAL VIT MULTI- MULTI- SOUTH EGYPT DRUG EGYPT ORAL SOLID 1.0X2.0X1 7/1/2005
DP/6788 DRUG SPECTRUM G INGREDIENTS INGREDIEN INDUSTRIES CO. (SEDICO)- ORDINARY 0.0
INDUSTRIES ENTERPRISES TS 1ST INDUSTRIAL ZONE, S" CAPSULES CAPSULE
CO. (SEDICO) (U) LIMITED OF OCTOBER CITY, EGYPT. BLISTER
PO. BOX 43, OCTOBER
CITY. POSTAL CODE
NO.12566
3146 NDA/MAL/H STRIDES ROYAL PHARMA DICLOSAL DICLOFENAC 75MG/3ML STRIDES ARCOLAB LTD. - INDIA PARENTERAL 1.0X1.0X5 7/1/2007
DP/6789 ARCOLAB LTD 2011 LIMITED SODIUM 36/7 ORDINARY .0X3.0 ML
SURAGAJAKKANAHALLI AMPOULES AMPOULE
INDLAVADI CROSS ANEKAL
TALUK
3147 NDA/MAL/H MEGA ABACUS LIMZER OMEPRAZOLE 20MG + INVENTIA HEALTHCARE INDIA ORAL SOLID 1.0X3.0X1 7/1/2016
DP/6790 LIFESCIENCES PHARMA + 30MG PVT. LTD-FI – FI /1 ORDINARY 0.0
(AUSTRALIA) (AFRICA) DOMPERIDO ADDITIONAL AMBERNATH, CAPSULES CAPSULE
PTY LTD LIMITED NE M.I.D.C. AMBERNATH STRIP
(EAST) – 421 506, DIST.
THANE, INDIA
3148 NDA/MAL/H UMEDICA VITACARE CIMETIDINE CIMETIDINE 200MG UMEDICA LABORATORIES INDIA ORAL SOLID 1.0X10.0X 7/1/2020
DP/6791 LABORATORIE LIMITED PVT. LTD-PLOT 221-GIDC, ORDINARY 10.0
S PVT LTD 2ND PHASE, VAPI 396195 TABLETS TABLET
GUJARAT STRIP
3149 NDA/MAL/H JANSSEN- MEDICAL PREZISTA DARUNAVIR 400MG JANSSEN ORTHO LLC.-- UNITED ORAL SOLID 1.0X60.0 7/1/2017
DP/6792 CILAG ACCESS STATE ROAD 933 KM 0.1 STATES ORDINARY TABLET
INTERNATION (UGANDA) MARNEY WARD GURABO FILM- CONTAIN
AL NV LIMITED PUERTO RICO 00778 COATED ER
TABLETS
3150 NDA/MAL/H HETERO LABS AIVEEN (U) ZOLID LINEZOLID 600MG HETERO LABS LIMITED INDIA ORAL SOLID 1.0X10.0X 7/1/2017
DP/6794 LTD LIMITED UNIT V-APIIC PHARMA ORDINARY 1.0X10.0
SEZ, S. NO. 439, 440, 441 FILM- TABLET
POLEPALLY TABLETS
VILLAGE, JADCHERLA
MANDAL,
MAHABOOBNAGAR
(DISTRICT). PIN
509301
3151 NDA/MAL/H PHARAONIA WIDE CRONOMES BETAMETHAS 1%W/W PHARAONIA EGYPT TOPICAL 1.0X15.0 7/1/2016
DP/6795 PHARMACEUT SPECTRUM ONE ONE PHARMACEUTICALS-NEW EXTERNAL G TUBE
ICALS ENTERPRISES OINTMENT VALERATE BORG EL ARAB CITY- OINTMENTS
(U) LIMITED ALEXANDRIA
3152 NDA/MAL/H MARTINDALE LABOREX PETHIDINE PETHIDINE 100MG/2 MARTINDALE UNITED PARENTERAL 1.0X2.0 7/1/1997
DP/6797 PHARMACEUT UGANDA INJECTION ML PHARMACEUTICAL KINGDOM ORDINARY ML
RMM38UG ENGLAND
3153 NDA/MAL/H UMEDICA VITACARE PRAZIQUA PRAZIQUANT 600MG UMEDICA LABORATORIES INDIA ORAL SOLID 1.0X8.0 7/1/2005
DP/6798 LABORATORIE LIMITED NTEL EL PVT. LTD-PLOT 221-GIDC, ORDINARY TABLET
S PVT LTD TABLETS 2ND PHASE, VAPI 396195 TABLETS BOTTLE
USP 600MG GUJARAT
3154 NDA/MAL/H BOEHRINGER SURGIPHARM MOBIC 7.5 MELOXICAM 7.5MG BOEHRINGER INGELHEIM GERMANY ORAL SOLID 1.0X10.0 1/7/2002
DP/6805 INGELHEIM (U) LIMITED TABLETS PHARMA GMBH & CO. ORDINARY TABLET
INTERNATION KG.,-BIRKENDORFER TABLETS CONTAIN
AL GMBH STRASSE 65, 88397, ER,1.0X3.
BIBERACH AN DER RISS 0X10.0
TABLET
BLISTER
3155 NDA/MAL/H F. HOFFMANN- LABOREX RECORMO EPOETIN 2000 ROCHE DIAGNOSTICS GERMANY PARENTERAL 1.0X6.0X0 7/1/2016
DP/6806 LA ROCHE UGANDA N BETA IU/0.3ML GMBH MANNHEIM - ORDINARY .3 ML PRE-
LIMITED SANDHOFER STRABE 116, PRE-FILLED FILLED
68305, MANNHEIM SYRINGES SYRINGE
3156 NDA/MAL/H GLAXOSMITH UNITED AUGMENTI AMOXICILLIN 600MG + GLAXO WELLCOME FRANCE ORAL LIQUID 1.0X100.0 7/1/2016
DP/6807 KLINE LTD HEALTHCARE N ES TRIHYDRATE 42.9MG PRODUCTION -Z.I DE LA ORDINARY ML
DISTRIBUTORS + POTASSIUM PEYENNIERE 53100 DRY BOTTLE
LTD CLAVULANAT MAYENNE FRANCE SUSPENSION
E S/SYRUPS/D
ROPS
3157 NDA/MAL/H ABACUS ABACUS GLYGEN- METFORMIN 500MG LINCOLN INDIA ORAL SOLID 1.0X10.0X 7/1/2016
DP/6808 PARENTERAL PARENTERAL 500 HYDROCHLOR PHARMACEUTICALS LTD-- ORDINARY 10.0
DRUGS DRUGS LIMITED IDE TRIMUL ESTATE AFER FILM- TABLET
LIMITED VODSAR VILLAGE KHATJAT COATED BLISTER
382 721 GUJARAT VADSAR TABLETS
GANDHINAGAR INDIA
3158 NDA/MAL/H GLAXOSMITH UNITED CERVARIX HUMAN TYPE 16 L1 GLAXOSMITHKLINE BELGIUM PARENTERAL 1.0X10.0X 7/1/2007
DP/6810 KLINE HEALTHCARE PAPILLOMA PROTEIN + BOILOGICALS-S.A RUE DE ORDINARY 0.5 ML
PHARMACEUT DISTRIBUTORS VIRUS TYPE 18 L1 I'INSTITUT 89 B-1330 PRE-FILLED VIAL,1.0X
ICAL KENYA LTD VACCINE PROTEIN + RIXENSART SYRINGES 0.5 ML
LTD (RDNA) 3-0- PRE-
DESACYL- FILLED
4'MONOP SYRINGE
HOSPHORY (1 DOSE) +
L LIPID A 25
A(MPL) GAUGE
NEEDLE
3159 NDA/MAL/H ABACUS ABACUS NOFLOX NORFLOXACI 0.3%W/V ABACUS PARENTERAL UGANDA OPHTHALMI 1.0X10.0 7/1/2016
DP/6812 PARENTERAL PARENTERAL N DRUGS LIMITED-PLOT 114, C DROPS ML
DRUGS DRUGS LIMITED BLOCK 191 BOTTLE
LIMITED
3160 NDA/MAL/H ABACUS ABACUS ABCROM SODIUM 2%W/V ABACUS PARENTERAL UGANDA OPHTHALMI 1.0X10.0 7/1/2016
DP/6815 PARENTERAL PARENTERAL EYE DROPS CROMOGLYC DRUGS LTD.-PLOT NO. C DROPS ML
DRUGS DRUGS LIMITED ATE 114, BLOCK 191, BOTTLE,1.
LIMITED GWAGAMYA, KINGA, 0X5.0 ML
KAPEKE, BOTTLE
MUKONO
3161 NDA/MAL/H DENK PARMA BENLE CONSULT LETROZOLE LETROZOLE 2.5MG HAUPT PHARMA GERMANY ORAL SOLID 1.0X3.0X1 7/1/2016
DP/6817 GMBH & CO. LIMITED DENK 2.5 MÜNSTER GMBH- ORDINARY 0.0
KG SCHLEEBRÜGGENKAMP 15 FILM- TABLET
48159 MÜNSTER COATED BLISTER
GERMANY TABLETS
3162 NDA/MAL/H SANOFI LABOREX IMOVAX POLIO VIRUS; 40 D + 8D + SANOFI PASTEUR- FRANCE PARENTERAL 1.0X1.0 7/1/2016
DP/6818 PASTEUR UGANDA POLIO (MAHONEY) 32 D MÉRIEUX 69280 MARCY ORDINARY ML VIAL
LIMITED TYPE 1- ANTIGEN L’ETOILE VIALS
INACTIVE + UNITS/
(MEF-1) TYPE 0.5ML
2- INACTIVE +
(SAUKETT)
TYPE 3-
INACTIVE
3163 NDA/MAL/H ABACUS ABACUS ABBORI BORIC ACID 1.83%W/V ABACUS PARENTERAL UGANDA OTIC DROPS 1.0X10.0 7/1/2017
DP/6820 PARENTERAL PARENTERAL EAR DROPS DRUGS LIMITED-BLOCK ML
DRUGS DRUGS LIMITED 191, PLOT NO. 114, BOTTLE
KAPEKA MUKONO
DISTRICT, UGANDA.
3164 NDA/MAL/H LABOREX LABOREX MAGNESIU MAGNESIUM 50%W/V MARTINDALE UNITED PARENTERAL 1.0X2.0X5 7/1/2016
DP/6821 UGANDA UGANDA M SULPHATE PHARMACEUTICAL KINGDOM ORDINARY .0X10.0
LIMITED LIMITED SULPHATE LIMITED -BAMPTON ROAD AMPOULES ML
INJECTION RMM38UG ENGLAND AMPOULE
3165 NDA/MAL/H LABOREX LABOREX EPHEDRINE EPHEDRINE 30MG/ML MARTINDALE UNITED PARENTERAL 1.0X2.0X5 7/1/2016
DP/6823 UGANDA UGANDA HYDROCHL HYDROCHLOR PHARMACEUTICALS .- KINGDOM ORDINARY .0X1.0 ML
LIMITED LIMITED ORIDE IDE ROMFORD ESSEX RM3 AMPOULES AMPOULE
8UG UK
3166 NDA/MAL/H ROCHE LABOREX FANSIDAR SULFADOXINE 525MG ROCHE PRODUCTS PTY SOUTH ORAL SOLID 1.0X50.0X 7/1/1997
DP/6825 UGANDA /PYRIMETHA LTD.-1600 ISANDO SOUTH AFRICA ORDINARY 3.0
LIMITED MINE AFRICA TABLETS TABLET
STRIP,1.0X
50.0X10.0
TABLET
STRIP
3167 NDA/MAL/H DENK PARMA BENLE CONSULT ON.SENTRO ONDANSETR 8MG DENK PHARMA GMBH & GERMANY ORAL SOLID 1.0X6.0 7/1/2016
DP/6833 GMBH & CO. LIMITED N-DENK ON CO. KG -GOLLSTR. 1 84529 ORDINARY TABLET
KG 8MG ODT TITTMONING SOLUBLE BLISTER
TABLETS
3168 NDA/MAL/H CADILA KARURI FYTOBACT CEFOPERAZO 0.5 G + 0.5 CADILA INDIA PARENTERAL 1.0X1.0 G 7/1/2009
DP/6843 PHARMACEUT PHARMACEUTIC NE + G PHARMACEUTICALS ORDINARY VIAL
ICALS LIMITED ALS LTD. SULBACTAM LIMITED-1389, TRASAD DRY VIALS
STATE, INDIA
3169 NDA/MAL/H CADILA KARURI FYTOBACT SULBACTAM 1G + 1G CADILA INDIA PARENTERAL 1.0X2.0 G 7/1/2017
DP/6845 PHARMACEUT PHARMACEUTIC 2G SODIUM + PHARMACEUTICALS ORDINARY VIAL
ICALS LIMITED ALS LTD. CEFOPERAZO LIMITED-1389, TRASAD DRY VIALS
NE SODIUM ROAD, DHOLKA- 382225,
STATE, INDIA
3170 NDA/MAL/H BRAWN ESCORTS BRUCIPRO CIPROFLOXAC 500MG BRAWN LABORATORIES INDIA ORAL SOLID 10.0X10.0 11/29/2017
DP/6857 LABORATORIE PHARMACEUTIC TABLETS IN LTD.-13, NIT, INDUSTRIAL ORDINARY TABLET
HARYANA COATED
TABLETS
3171 NDA/MAL/H BRAWN ESCORTS BRUVEL- LEVOFLOXACI 500MG BRAWN LABORATORIES INDIA ORAL SOLID 1.0X10.0X 9/26/2018
DP/6859 LABORATORIE PHARMACEUTIC 500 N LTD..-13,NEW INDUSTRIAL ORDINARY 10.0
S LTD ALS LIMITED TABLETS HEMIHYDRAT TOWNSHIP, FARIDABAD- FILM- TABLET
E 121 001,HARYANA -INDIA COATED BLISTER
TABLETS
3172 NDA/MAL/H BRAWN ESCORTS DITS GEL DICLOFENAC 1%W/W BRAWN LABORATORIES INDIA TOPICAL 1.0X15.0 7/1/2017
DP/6862 LABORATORIE PHARMACEUTIC DIETHYLAMIN LTD.-13, NIT, INDUSTRIAL EXTERNAL G
S LTD ALS LIMITED E AREA, FARIDABAD-121001, GELS AND TUBE,1.0X
HARYANA SOLS 10.0 G
TUBE
3173 NDA/MAL/H BRAWN ESCORTS DITS DICLOFENAC 25MG/ML BRAWN LABORATORIES INDIA PARENTERAL 1.0X5.0X3 11/29/2017
DP/6865 LABORATORIE PHARMACEUTIC INJECTION SODIUM LTD.-13, NIT, INDUSTRIAL ORDINARY .0 ML
S LTD ALS LIMITED AREA, FARIDABAD-121001, AMPOULES AMPOULE
HARYANA
3174 NDA/MAL/H BRAWN ESCORTS HYDROSON HYDROCORTI 100MG BRAWN LABORATORIES INDIA PARENTERAL 1.0X1.0 11/29/2017
DP/6870 LABORATORIE PHARMACEUTIC E 100MG SONE LTD.-13, NIT, INDUSTRIAL ORDINARY VIAL
S LTD ALS LIMITED SODIUM AREA, FARIDABAD-121001, DRY VIALS CARTON
SUCCINATE HARYANA (1*100MG
GLASS
VIAL +
1*2ML
AMP WFI)
3175 NDA/MAL/H BRAWN ESCORTS VIVAX 100 SILDENAFIL 100MG BRAWN LABORATORIES INDIA ORAL SOLID 1.0X1.0X4 9/26/2018
DP/6871 LABORATORIE PHARMACEUTIC LTD..-13,NEW INDUSTRIAL ORDINARY .0 TABLET
S LTD ALS LIMITED TOWNSHIP, FARIDABAD- FILM- BLISTER
121 001,HARYANA -INDIA COATED
TABLETS
3176 NDA/MAL/H BRAWN ESCORTS NETRACOR OXYTETRACY 10MG+5M BRAWN LABORATORIES INDIA OPHTHALMI 1.0X5.0 7/1/2017
DP/6872 LABORATORIE PHARMACEUTIC TIL CLINE G+10000I. LTD.-13, NIT, INDUSTRIAL C ML
S LTD ALS LIMITED EYE/EAR HYDROCHLOR U AREA, FARIDABAD-121001, SUSPENSION BOTTLE
SUSPENSIO IDE HARYANA S
N +HYDROCORT
ISONE
ACETATE+POL
YMYXIN B
SULPHATE
3177 NDA/MAL/H BRAWN ESCORTS ROXITHIN ROXITHROMY 150MG BRAWN LABORATORIES INDIA ORAL SOLID 1.0X10.0X 9/26/2018
DP/6873 LABORATORIE PHARMACEUTIC TABLETS CIN LTD..-13,NEW INDUSTRIAL ORDINARY 10.0
S LTD ALS LIMITED TOWNSHIP, FARIDABAD- FILM- TABLET
121 001,HARYANA -INDIA COATED BLISTER
TABLETS
3178 NDA/MAL/H BRAWN ESCORTS CEZIN CETIRIZINE 10MG BRAWN LABORATORIES INDIA ORAL SOLID 1.0X10.0X 7/1/2017
DP/6874 LABORATORIE PHARMACEUTIC TABLETS HYDROCHLOR LTD.-13, NIT, INDUSTRIAL ORDINARY 10.0
S LTD ALS LIMITED IDE AREA, FARIDABAD-121001, FILM- TABLET
HARYANA COATED BLISTER
TABLETS
3179 NDA/MAL/H BRAWN ESCORTS BRUMOX- AMOXICILLIN 250MG BRAWN LABORATORIES INDIA ORAL SOLID 10.0X10.0 7/1/2017
DP/6875 LABORATORIE PHARMACEUTIC 250 TRIHYDRATE LTD.-13, NIT, INDUSTRIAL ORDINARY CAPSULE
S LTD ALS LIMITED CAPSULES AREA, FARIDABAD-121001, CAPSULES BLISTER
HARYANA
3180 NDA/MAL/H ASTRA ASTRA PHARMA ASTRALEVO LEVOFLOXACI 500MG ASTRA LIFE CARE(INDIA) INDIA ORAL SOLID 1.0X10.0 1/31/2018
DP/6881 LIFECARE (U) LIMITED FLOXA N PVT LTD-PLOT NO. 57/P, ORDINARY TABLET
(INDIA) PVT. SARKHEJ – BAVLA FILM- BLISTER
LTD HIGHWAY, POST. RAJODA COATED
– 382220, TALUKA: BAVLA, TABLETS
DIST. AHMEDABAD
3181 NDA/MAL/H BROOKES HARLEYS PYODINE POVIDONE 1G/100ML BROOKES PAKISTAN ORAL 1.0X60.0 7/1/2006
DP/6897 PHARMACEUT UGANDA GARGLE & IODINE PHARMACEUTICALS TOPICAL ML
ICAL LIMITED MOUTH LABORATORIES LIQUIDS BOTTLE
LABORATORIE WASH (PAKISTAN) LTD-PLOT 58
SL SECTOR 15 KORANGI
INDUSTRIAL AREA,
KARACHI-PAKISTAN
3182 NDA/MAL/H F.HOFFMANN- LABOREX HERCEPTIN TRASFUZUMA 600 MG F.HOFFMANN LA ROACHE SWITZERLAN PARENTERAL 1.0X1.0 8/28/2019
DP/6909 LA ROCHE LTD UGANDA B AG, KAISRAUGST - D ORDINARY VIAL
LIMITED BETRIEBSSTANDORT DRY VIALS CARTON
KAISERAUGST, 4303
KAIERAUGST
3183 NDA/MAL/H ATCO HARLEYS SCABION CROTAMITON 10 G + 2 G ATCO LABS LTD,-B-18, INDIA TOPICAL 1.0X20.0 7/1/2004
DP/6911 LABORATORIE UGANDA + SULPHUR S.I.T.E, KARACHI EXTERNAL G TUBE
S LTD LIMITED CREAMS
3184 NDA/MAL/H CADILA ABACUS ZYROVA 5 ROSUVASTATI 5 MG CADILA HEALTHCARE INDIA ORAL SOLID 1.0X3.0X1 8/28/2019
DP/6912 HEALTHCARE PHARMA N CALCIUM LIMITED -KUNDAIM ORDINARY 0.0
GOA, 403115,
3185 NDA/MAL/H CADILA ABACUS ZYROVA 10 ROSUVASTATI 10 MG CADILA HEALTHCARE INDIA ORAL SOLID 1.0X3.0X1 8/28/2019
DP/6913 HEALTHCARE PHARMA N CALCIUM LIMITED -KUNDAIM ORDINARY 0.0
GOA, 403115,
3186 NDA/MAL/H COSMOS ASTRA PHARMA DAPSONE DAPSONE 100 MG COSMOS LTD -RANGWE KENYA ORAL SOLID 1.0X10.0X 8/28/2019
DP/6917 LIMITED (U) LIMITED ROAD OFF LUNGA LUNGA ORDINARY 10.0
ROAD INDUSTRIAL AREA TABLETS TABLET
NAIROBI BLISTER
3187 NDA/MAL/H RESONANT SHREEJI NO COLD PARACTAMOL 500MG + CRIS PHARMA (INDIA) UGANDA ORAL SOLID 1.0X50.0X 8/28/2019
DP/6918 PHARMACEUT PHARMACEUTIC + PHENYL 10MG + LIMITED-E-11, UPSIDC ORDINARY 4.0
ICALS ALS LIMITED HYDROCHLOR 2MG + INDUSTRIAL AREA, TABLETS TABLET
IDE + 30MG SELAQUI, DEHRADUN, BLISTER,1.
CHLORPHENA UTTARAKHAND INDIA 0X25.0X4.
MINE 0 TABLET
MALEATE + BLISTER
CAFFEINE
ANHYDROUS
3188 NDA/MAL/H MACLEODS NORVIK MACSUNAT ARTESUNATE 50MG + MACLEODS INDIA ORAL SOLID 1.0X3.0 3/27/2019
DP/6919 PHARMACEUT ENTERPRISES E AQ + 135MG PHARMACEUTICALS LTD.- ORDINARY TABLET
ICALS LTD LIMITED JUNIOR AMODIAQUIN PLOT NO. 25-27 SURVEY FILM- BLISTER,1.
E NO. 366, COATED 0X25.0X3.
PREMIER INDUSTRIAL TABLETS 0 TABLET
ESTATE, KACHIGAM, BLISTER
DAMAN (UT) - 396210,
INDIA.
3189 NDA/MAL/H I CARE AIVEEN (U) LTD - OFZOLE OFLOXACIN+ 200MG+50 CORONA REMEDIES PVT INDIA ORAL SOLID 1.0X1.0X1 12/3/2018
DP/6920 PHARMA WILSON ROAD ORNIDAZOLE 0MG LTD..-VILLAGE JATOLI, ORDINARY 0.0
LIMITED POST OFFICE - OACHGHAT, FILM- TABLET
TEHSIL SOLAN, DIST. COATED BLISTER
SOLAN TABLETS
HIMACHAL PRADESH
3190 NDA/MAL/H GUILIN PHILLIPS DUFENAC DICLOFENAC 75MG GUILIN PHARMACEUTICAL CHINA ORAL SOLID 1.0X10.0 7/1/2017
DP/6921 PHARMACEUT PHARMACEUTIC SODIUM CO LTD--NO. 43 QILIDIAN ORDINARY CAPSULE
ICAL ALS (UGANDA) ROAD GUILIN 541004 ENTERIC- BLISTER
(SHANGHAI) LIMITED GUANGXI COATED
CO., LTD CAPSULES
3191 NDA/MAL/H MACLEODS NORVIK MACSUNAT ARTESUNATE 25MG + MACLEODS INDIA ORAL SOLID 1.0X1.0X3 3/27/2019
DP/6923 PHARMACEUT ENTERPRISES E AQ KID + 67.5MG PHARMACEUTICALS LTD ,.- ORDINARY .0 TABLET
ICALS LTD LIMITED AMODIAQUIN PHASE I & II, PLOT NO. 25- FILM- BLISTER,1.
E 27 SURVEY NO. 366, COATED 0X25.0X3.
PREMIERE INDUSTRIAL TABLETS 0 TABLET
ESTATE, KACHIGAN, BLISTER
DAMAN-396210
3192 NDA/MAL/H I CARE AIVEEN (U) NAC MR DICLOFENAC 50MG+325 CORONA REMEDIES PVT INDIA ORAL SOLID 1.0X10.0 1/31/2018
DP/6924 PHARMA LIMITED POTASSIUM+ MG+250M LIMITED-VILLAGE JATOLI, ORDINARY TABLET
LIMITED PARACETAM G POST OFFICE - OACHGHAT, FILM- BLISTER
OL+CHLORZO TEHSIL SOLAN, DIST. COATED
XAZONE SOLAN HIMACHAL TABLETS
PRADESH – 173223. INDIA
3193 NDA/MAL/H SK AGE ABACUS ERYTHROK ERYTHROMYC 125MG/5 S KANT HEALTHCARE LTD- INDIA ORAL LIQUID 1.0X60.0 5/29/2019
DP/6926 EXPORTS PHARMA ANT-ES IN ETHYL ML PLOT NO. 1805, G.I.D.C ORDINARY ML
(AFRICA) SUCCINATE PHASE III, VAPI 396195, LIQUIDS BOTTLE,1.
LIMITED GUJARAT 0X100.0
ML
BOTTLE
3194 NDA/MAL/H MSN ABACUS RANCV1000 RANOLAZINE 1000MG MSN LABORATORIES LTD- INDIA ORAL SOLID 1.0X3.0X1 3/27/2019
DP/6929 LABORATORIE PHARMA PLOT NO.42, ANRICH ORDINARY 0.0
S LTD (AFRICA) INDUSTRIAL ESTATE, FILM- TABLET
LIMITED BOLLARAM, INDIA COATED BLISTER
TABLETS
3195 NDA/MAL/H MSN METRO TAPAL 50 TAPENTADOL 50MG MSN LABORATORIES LTD- INDIA ORAL SOLID 1.0X1.0X1 3/27/2019
DP/6930 LABORATORIE PHARMACEUTIC PLOT NO.42, ANRICH ORDINARY 0.0
S LTD ALS LIMITED INDUSTRIAL ESTATE, FILM- TABLET
BOLLARAM, INDIA COATED BLISTER
TABLETS
3196 NDA/MAL/H ROYAL ROYAL PHARMA AMORIV AMBROXOL 15MG/5ML EAST AFRICAN (INDIA) INDIA ORAL LIQUID 1.0X100.0 8/28/2019
DP/6931 PHARMA 2011 LIMITED HYDROCHLOR OVERSEAS-PLOT NO.1, ORDINARY ML
2011 LIMITED IDE PHARMACITY SELAQUI SYRUPS BOTTLE
DEHRADUN – 248011
(U.K), INDIA
3197 NDA/MAL/H SANDOZ SURGIPHARM ANASTROZ ANASTROZOL 1MG SALUTAS PHARMA GMBH- GERMANY ORAL SOLID 1.0X3.0X1 7/1/2017
DP/6934 GMBH, (U) LIMITED OLE 1 MG E OTTO-VON-GUERICKE- ORDINARY 0.0
KUNDL ALLEE 1, 39179 BARLEBEN, FILM- TABLET
COATED BLISTER
TABLETS
3198 NDA/MAL/H SANDOZ SURGIPHARM SIMVASTAT SIMVASTATIN 40MG SANDOZ GRUP SAGLIK .- TURKEY ORAL SOLID 1.0X10.0X 7/1/2017
DP/6935 GMBH, (U) LIMITED IN 40 MG GEBZE 2 GOSB IHSAN ORDINARY 10.0
KUNDL DEDE CAD. 900. SOK FILM- TABLET
41480 GEBZE KOCAELI COATED BLISTER
TABLETS
3199 NDA/MAL/H MSN METRO TAPAL 100 TAPENTADOL 100MG MSN LABORATORIES LTD- INDIA ORAL SOLID 1.0X1.0X1 3/27/2019
DP/6939 LABORATORIE PHARMACEUTIC PLOT NO.42, ANRICH ORDINARY 0.0
S LTD ALS LIMITED INDUSTRIAL ESTATE, FILM- TABLET
BOLLARAM, INDIA COATED BLISTER
TABLETS
3200 NDA/MAL/H MSN ABACUS TOLVAT 30 TOLVAPTAN 30MG MSN LABORATORIES INDIA ORAL SOLID 1.0X1.0X4 11/7/2018
DP/6941 LABORATORIE PHARMA PRIVATE LIMITED - -PLOT ORDINARY .0 TABLET
S PRIVATE (AFRICA) 42 ANRICH INDUSTRIAL TABLETS BLISTER
LIMITED LIMITED ESTATE BOLLARAM
MEDAK DISTRICT,
TELANGANA 502325,
INDIA
3201 NDA/MAL/H MSN ABACUS TOLVAT 15 TOLVAPTAN 15MG MSN LABORATORIES INDIA ORAL SOLID 1.0X1.0X4 11/7/2018
DP/6942 LABORATORIE PHARMA PRIVATE LIMITED - -PLOT ORDINARY .0 TABLET
S PRIVATE (AFRICA) 42 ANRICH INDUSTRIAL TABLETS BLISTER
LIMITED LIMITED ESTATE BOLLARAM
MEDAK DISTRICT,
TELANGANA 502325,
INDIA
3202 NDA/MAL/H ADWIA WIDE ADWIFLAM DICLOFENAC 25MG SOUTH EGYPT DRUG EGYPT RECTAL 1.0X1.0X5 5/29/2019
DP/6943 SPECTRUM POTASSIUM INDUSTRIES CO. (SEDICO)- SYSTEMIC .0
ENTERPRISES 1ST INDUSTRIAL ZONE, 6 SUPPOSITORI SUPPOSIT
(U) LIMITED OCTOVER CITY, P.O. BOX ES ORY STRIP
43
3203 NDA/MAL/H SURGE LAB JEET TRICK-D CHOLECALCIF 5MG/ML SURGE LABORATORIES PAKISTAN OTHER 1.0X1.0 5/29/2019
DP/6945 (PVT) LIMITED PHARMACEUTIC EROL (PVT) LTD.,,-10TH KM, SYSTEMIC ML
ALS LIMITED FAISALABAD ROAD, BIKHI, LIQUIDS AMPOULE
PAKISTAN.
3204 NDA/MAL/H SURGE LAB JEET FEVERAL PARACETAM 1OMG/ML SURGE LABORATORIES PAKISTAN PARENTERAL 1.0X1.0X1 5/29/2019
DP/6946 (PVT) LIMITED PHARMACEUTIC OL (PVT) LTD.,,-10TH KM, ORDINARY I 00.0 ML
ALS LIMITED FAISALABAD ROAD, BIKHI, V VIALS VIAL
PAKISTAN.
3205 NDA/MAL/H SURGE LAB JEET MEGAFER IRON 100MG/5 SURGE LABORATORIES INDIA PARENTERAL 1.0X1.0X5 5/29/2019
DP/6949 (PVT) LIMITED PHARMACEUTIC SUCROSE ML (PVT) LTD.,,-10TH KM, ORDINARY .0X5.0 ML
ALS LIMITED FAISALABAD ROAD, BIKHI, AMPOULES AMPOULE
PAKISTAN.
3206 NDA/MAL/H SANDOZ SURGIPHARM TAMOXIFE TAMOXIFEN 20MG SALUTAS PHARMA GMBH- GERMANY ORAL SOLID 1.0X3.0X1 5/29/2019
DP/6966 GMBH . (U) LIMITED N CITRATE OTTO-VON-GUERICKE ORDINARY 0.0
ALLEE-1, 39179 BARLEBEN TABLETS TABLET
BLISTER
3207 NDA/MAL/H EVA PHARMA GAMA MICAZOLE MICONAZOLE 2%W/W EVA PHARMA FOR EGYPT ORAL 1.0X20.0 11/27/2019
DP/6967 FOR PHARMACEUTIC PHARMACEUTICALS AND TOPICAL G TUBE
PHARMACEUT ALS (U) LIMITED MEDICAL APPLIANCES-176 GELS AND
ICALS & EL SADAT ST. KAFR EL SOLS
APPLIANCES - EGYPT
3208 NDA/MAL/H F.HOFFMANN- LABOREX MABTHERA RITUXIMAB 1400MG/1 F.HOFFMANN LA ROACHE SWITZERLAN PARENTERAL 1.0X1.0X1 8/28/2019
DP/6968 LA ROCHE LTD UGANDA ® SC 3.4ML AG, KAISRAUGST - D ORDINARY S 3.4 ML
LIMITED 1400MG BETRIEBSSTANDORT C VIALS VIAL
KAISERAUGST, 4303
KAIERAUGST
3209 NDA/MAL/H F.HOFFMANN- LABOREX MABTHERA RITUXIMAB 1600MG/1 F.HOFFMANN LA ROACHE SWITZERLAN PARENTERAL 1.0X1.0X1 8/28/2019
DP/6969 LA ROCHE LTD UGANDA ® SC 3.4ML AG, KAISRAUGST - D ORDINARY S 3.4 ML
LIMITED 1600MG BETRIEBSSTANDORT C VIALS VIAL
KAISERAUGST, 4303
KAIERAUGST
3210 NDA/MAL/H EAST AFRICAN ROYAL PHARMA MONTIRIV- MONTELUKAS 10 MG EAST AFRICAN (INDIA) INDIA ORAL SOLID 1.0X3.0X1 8/28/2019
DP/6971 (INDIA) 2011 LIMITED 10 T SODIUM OVERSEAS-PLOT NO.1, ORDINARY 0.0
OVERSEAS PHARMACITY SELAQUI TABLETS TABLET
DEHRADUN – 248011 BLISTER
(U.K), INDIA
3211 NDA/MAL/H THE UNITED WIDE UNIFED DM TRIPROLIDINE 1.25MG + UNITED JORDAN ORAL LIQUID 1.0X120.0 11/27/2019
DP/6973 PHARMACEUT SPECTRUM SYRUP HYDROCHLOR 30MG + PHARMACEUTICALS ORDINARY ML
ICALS MFG, ENTERPRISES 120ML IDE + 10MG/5ML MANUFACTURING LTD CO- SYRUPS BOTTLE
CO. LTD, (U) LIMITED PSEUDOEPHE AL- RAGEEM, SAHAB, P.O
DRINE BOX 69, AMMAN 11591,
HYDROCHLOR JORDAN
IDE +
DEXTROMET
HORPHAN
3212 NDA/MAL/H MANKIND TATA UGANDA VOMIKIND- ONDANSETR 4MG MANKIND PHARMA INDIA ORAL SOLID 1.0X10.0 7/1/2017
DP/6974 PHARMA LIMITED MD 4 ON LIMITED, UNIT-II. -VILLAGE ORDINARY TABLET
LIMITED KISHANPURA, P.O ORALLY BLISTER
JAMNIWALA, PAONTA DISINTEGRA
SAHIB IN H.P. TING
TABLETS
3213 NDA/MAL/H EAST AFRICAN ROYAL PHARMA CELERIV- CELECOXIB 200 MG EAST AFRICAN (INDIA) INDIA ORAL SOLID 1.0X10.0X 8/28/2019
DP/6975 (INDIA) 2011 LIMITED 200 OVERSEAS-PLOT NO.1, ORDINARY 10.0
OVERSEAS PHARMACITY SELAQUI CAPSULES CAPSULE
(U.K), INDIA
3214 NDA/MAL/H EAST AFRICAN ROYAL PHARMA KETORIV KETOCONAZO 2%W/W EAST AFRICAN (INDIA) INDIA TOPICAL 1.0X75.0 8/28/2019
DP/6976 (INDIA) 2011 LIMITED SOAP LE OVERSEAS-PLOT NO.1, EXTERNAL G SACHET
OVERSEAS PHARMACITY SELAQUI SOLID
DEHRADUN – 248011 SOAPS/BARS
(U.K), INDIA
3215 NDA/MAL/H EAST AFRICAN ROYAL PHARMA CLINDARIV CLINDAMYCI 1.0%W/W EAST AFRICAN (INDIA) INDIA TOPICAL 1.0X1.0X2 8/28/2019
DP/6977 (INDIA) 2011 LIMITED N OVERSEAS-PLOT NO.1, EXTERNAL 0.0 G
OVERSEAS PHOSPHATE PHARMACITY SELAQUI CREAMS TUBE
DEHRADUN – 248011
(U.K), INDIA
3216 NDA/MAL/H EAST AFRICAN ROYAL PHARMA DEXARIV DEXAMETHAS 4 MG/ML EAST AFRICAN (INDIA) INDIA PARENTERAL 1.0X5.0X2 8/28/2019
DP/6978 (INDIA) 2011 LIMITED ONE SODIUM OVERSEAS-PLOT NO.1, ORDINARY .0 ML
OVERSEAS PHOSPHATE PHARMACITY SELAQUI VIALS VIAL,1.0X
DEHRADUN – 248011 100.0X2.0
(U.K), INDIA ML VIAL
3217 NDA/MAL/H ROYAL ROYAL PHARMA TERBIRIV TERBINAFINE 1.0%W/W EAST AFRICAN (INDIA) INDIA TOPICAL 1.0X1.0X2 8/28/2019
DP/6979 PHARMA 2011 LIMITED HYDROCHLOR OVERSEAS-PLOT NO.1, EXTERNAL 0.0 G
2011 LIMITED IDE PHARMACITY SELAQUI CREAMS TUBE
DEHRADUN – 248011
(U.K), INDIA
3218 NDA/MAL/H EAST AFRICAN ROYAL PHARMA KETORIV KETOCONAZO 2.0%W/W EAST AFRICAN (INDIA) INDIA NASAL 1.0X1.0X1 8/28/2019
DP/6980 (INDIA) 2011 LIMITED LE OVERSEAS-PLOT NO.1, TOPICAL 5.0 G
OVERSEAS PHARMACITY SELAQUI CREAMS TUBE
DEHRADUN – 248011
(U.K), INDIA
3219 NDA/MAL/H ZIFAM BOOTS KIT LANZ LANSOPRAZO 30MG + FREDUN INDIA ORAL SOLID 1.0X7.0X6 8/28/2019
DP/6981 PINNACLE PHARMACEUTIC LE + 250MG + PHARMACEUTICALS ORDINARY .0 TABLET
PTY. LTD. ALS LIMITED CLARITHROM 500MG LIMITED-14,15,16, OTHER BLISTER
YCIN + ZORABIAN INDUSTRIAL SPECIAL PACK HAS
TINIDAZOLE COMPLEX,VEOOR,PALGHA FORMS BOTH
R (E), DIST: PALGHAR-401 CAPSULES
404 AND
TABLETS
3220 NDA/MAL/H EAST AFRICAN ROYAL PHARMA DEXARIV DEXAMETHAS 0.5 MG EAST AFRICAN (INDIA) INDIA ORAL SOLID 1.0X10.0X 8/28/2019
DP/6982 (INDIA) 2011 LIMITED ONE SODIUM OVERSEAS-PLOT NO.1, ORDINARY 10.0
OVERSEAS PHOSPHATE PHARMACITY SELAQUI TABLETS TABLET
(U.K), INDIA
3221 NDA/MAL/H ROYAL ROYAL PHARMA FASICON FLUCONAZOL 200 MG EAST AFRICAN (INDIA) INDIA ORAL SOLID 1.0X2.0X1 8/28/2019
DP/6983 PHARMA 2011 LIMITED E OVERSEAS-PLOT NO.1, ORDINARY 0.0
2011 LIMITED PHARMACITY SELAQUI CAPSULES CAPSULE
(U.K), INDIA
3222 NDA/MAL/H EAST AFRICAN ROYAL PHARMA VIREXIM- CEFIXIME 400 MG EAST AFRICAN (INDIA) INDIA ORAL SOLID 1.0X1.0X5 8/28/2019
DP/6984 (INDIA) 2011 LIMITED 400 TRIHYDRATE OVERSEAS-PLOT NO.1, ORDINARY .0
OVERSEAS PHARMACITY SELAQUI CAPSULES CAPSULE
DEHRADUN – 248011 BLISTER,1.
(U.K), INDIA 0X10.0X10
.0
CAPSULE
BLISTER
3223 NDA/MAL/H MEDLEY MEDVIN COLDRID CETIRIZINE 2.5MG + MEDLEY INDIA ORAL LIQUID 1.0X100.0 7/1/2017
DP/6985 PHARMACEUT PHARMA SYRUP DIHYDROCHL 5MG + PHARMACEUTICALS, LTD- ORDINARY ML
ICALS LTD LIMITED ORIDE + 125MG PLOT 18/19 ZORIC CORSE SYRUPS BOTTLE
PHENYLEPHRI WAY ROAD KACHIGAM
NE HCL + DAMAN
PARACETAM
OL
3224 NDA/MAL/H MEDLEY MEDVIN REPRAZ 20 RABEPRAZOL 20MG MEDLEY INDIA ORAL SOLID 1.0X3.0X1 7/1/2017
DP/6986 PHARMACEUT PHARMA TABLETS E SODIUM PHARMACEUTICALS LTD- ORDINARY 0.0
ICALS LTD LIMITED PLOT NO.18 AND 19, ENTERIC- TABLET
ESTATE, KACHIGAM,
DAMAN-396210 INDIA
3225 NDA/MAL/H MEDLEY MEDVIN PORAZ OMEPRAZOLE 20MG MEDLEY INDIA ORAL SOLID 1.0X10.0X 7/1/2017
DP/6987 PHARMACEUT PHARMA CAPSULES PHARMACEUTICALS LTD- ORDINARY 10.0
ICALS LTD LIMITED PLOT NO.18 AND 19, ENTERIC- CAPSULE
SURVEY NO.378/8 & COATED STRIP
379/2, KEBRA INDUSTRIAL CAPSULES
ESTATE, KACHIGAM,
DAMAN-396210 INDIA
3226 NDA/MAL/H I-CARE AIVEEN (U) ESZOLE ESOMEPRAZO 40 MG CORONA REMEDIES PVT. INDIA ORAL SOLID 1.0X3.0X1 8/28/2019
DP/6988 PHARMA LTD LIMITED LE LTD-VILLAGE JATOLI, POST ORDINARY 0.0
MAGNESIUM OFFICE- OACHGHAT, ENTERIC- TABLET
TRIHYDRATE TEHSIL, SOLAN, DISTT. COATED BLISTER
SOLAN (H.P) 173223 TABLETS
3227 NDA/MAL/H THE UNITED WIDE UNIFED TRIPROLIDINE 1.25MG+3 UNITED JORDAN ORAL LIQUID 1.0X120.0 11/27/2019
DP/6989 PHARMACEUT SPECTRUM EXPECTORA HYDROCHLOR 0MG+100 PHARMACEUTICALS ORDINARY ML
ICALS MFG, ENTERPRISES NT SYRUP IDE + MG/5ML MANUFACTURING LTD CO- SYRUPS BOTTLE
CO. LTD, (U) LIMITED 120ML PSEUDOEPHE AL- RAGEEM, SAHAB, P.O
HYDROCHLOR JORDAN
IDE +
GUAIFENESIN
3228 NDA/MAL/H STALLION SHREEJI T-MEF TRANEXAMIC 250MG + ACME FORMULATION PVT. INDIA ORAL SOLID 1.0X10.0X 8/28/2019
DP/6995 LABORATORIE PHARMACEUTIC ACID + 500MG LTD-ROPAR ROAD, ORDINARY 10.0
S PVT LTD ALS LIMITED MEFENAMIC NALAGARH, DIST. SOLAN, TABLETS TABLET
ACID HIMACHAL PRADESH BLISTER
174101
3229 NDA/MAL/H HETERO LABS AIVEEN (U) EC-PRAM ESCITALOPRA 10MG HETERO LABS LTD. UNIT INDIA ORAL SOLID 1.0X3.0X1 5/30/2018
DP/6997 LTD LIMITED 10 M OXALATE (V)-S.N0.439, 440, 441& ORDINARY .0X10.0
458, APIIC, PHARMA SEZ, FILM- TABLET
509301 INDIA
3230 NDA/MAL/H STALLION SHREEJI L-DIPIN-55 LOSARTAN 50MG + ACME FORMULATION PVT. INDIA ORAL SOLID 1.0X10.0X 8/28/2019
DP/6998 LABORATORIE PHARMACEUTIC POTASSIUM + 5MG LTD-ROPAR ROAD, ORDINARY 10.0
S PVT LTD ALS LIMITED AMLODIPINE NALAGARH, DIST. SOLAN, TABLETS TABLET
BESILATE HIMACHAL PRADESH BLISTER
174101
3231 NDA/MAL/H CIRON ROYAL PHARMA NYSTATIN NYSTATIN 100000 CIRON DRUGS & INDIA ORAL LIQUID 1.0X30.0 1/31/2018
DP/6999 DRUGS & 2011 LIMITED ORAL UNITS/5ML PHARMACEUTICALS PVT ORDINARY ML
PHARMACEUT SUSPENSIO LTD-N-118, N-119, N-113 DRY BOTTLE
ICAL PVT LTD N MIDC TARAPUR BOISAR SUSPENSION
DIST. THANE 401506 S/SYRUPS/D
MAHARASHTRA ROPS
3232 NDA/MAL/H CADILA ABACUS DACIHEP 60 DACLATASVIR 60 MG CADILA HEALTHCARE INDIA ORAL SOLID 1.0X3.0X1 8/28/2019
DP/7001 HEALTHCARE PHARMA DIHYDROCHL LIMITED -KUNDAIM ORDINARY 0.0
LIMITED (AFRICA) ORIDE INDUSTRIAL ESTATE,PLOT FILM- TABLET
3233 NDA/MAL/H CIPLA QUALITY LOPINAVIR LOPINAVIR + 40MG + CIPLA LTD-UNIT VII INDIA ORAL SOLID 1.0X120.0 9/6/2019
DP/7002 LIMITED CHEMICALS LTD - AND RITONAVIR 10MG PRODUCTION II, PLOT ORDINARY CAPSULE
HUMAN RITONAVIR NOS. S-103 TO S-105, S- CAPSULES BOTTLE
107 TO S-112, L-147/1 TO
L-147/3, L-138, L-147/A,
VERNA INDUSTIRAL
GOA
3234 NDA/MAL/H I CARE AIVEEN (U) NAC-SP DICLOFENAC 50MG + CORONA REMEDIES PVT INDIA ORAL SOLID 1.0X3.0X1 2019-11-07
DP/7003 PHARMA LIMITED POTASSIUM + 10MG LTD..-VILLAGE JATOLI, ORDINARY 0.0
LIMITED SERRATIOPEP POST OFFICE - OACHGHAT, ENTERIC- TABLET
TIDASE TEHSIL SOLAN, DIST. COATED BLISTER
SOLAN TABLETS
HIMACHAL PRADESH
3235 NDA/MAL/H MEGA ABACUS DUOCETZ PARACETAM 325MG+37 MEGA LIFE SCIENCES THAILAND ORAL SOLID 1.0X3.0X1 1/31/2018
DP/7004 LIFESCIENCES PHARMA OL+TRAMAD .5MG PUBLIC COMPANY ORDINARY 0.0
PUBLIC (AFRICA) OL LIMITED..-515/1 MOO 4, FILM- TABLET
COMPANY LIMITED HYDROCHLOR SOI 8, BANGPOO COATED BLISTER
LTD IDE INDUSTRIAL ESTATE, TABLETS
PATTANA 3 ROAD,
PHRAEKSA, MUEANG
3236 NDA/MAL/H CIPLA QUALITY ABACAVIR, ABACAVIR + 600MG + CIPLA LTD-UNIT VII INDIA ORAL SOLID 1.0X30.0 8/28/2019
DP/7005 LIMITED CHEMICALS LTD - DOLUTEGR DOLUTEGRAV 50MG + PRODUCTION II, PLOT ORDINARY TABLET
HUMAN AVIR AND IR + 300MG NOS. S-103 TO S-105, S- TABLETS BOTTLE
LAMIVUDIN LAMIVUDINE 107 TO S-112, L-147/1 TO
E L-147/3, L-138, L-147/A,
VERNA INDUSTIRAL
GOA
3237 NDA/MAL/H MSN ABACUS EPNONE 50 EPLERENONE 50MG MSN LABORATORIES INDIA ORAL SOLID 1.0X3.0X1 1/25/2019
DP/7007 LABORATORIE PHARMA PRIVATE LIMITED - -PLOT ORDINARY 0.0
S LTD (AFRICA) 42 ANRICH INDUSTRIAL FILM- TABLET
LIMITED ESTATE BOLLARAM COATED BLISTER
MEDAK DISTRICT, TABLETS
TELANGANA 502325,
INDIA
3238 NDA/MAL/H CIPLA LTD. QUALITY DARUNAVI DARUNAVIR 400 MG CIPLA LTD ,.-PLOT NO. A- INDIA ORAL SOLID 1.0X60.0 8/28/2019
DP/7008 CHEMICALS LTD - R TABLETS ETHANOLATE 33, A-2 (UNIT 1), A42 ORDINARY TABLET
HUMAN (UNIT II), MIDC FILM- CONTAIN
PATALGANGA, DISTRICT- COATED ER
RAIGAD MAHARASHTRA, TABLETS
410220 INDIA
3239 NDA/MAL/H CIPLA LTD. QUALITY DARUNAVI DARUNAVIR 600 MG CIPLA LTD ,.-PLOT NO. A- INDIA ORAL SOLID 1.0X60.0 8/28/2019
DP/7009 CHEMICALS LTD - R TABLETS ETHANOLATE 33, A-2 (UNIT 1), A42 ORDINARY TABLET
HUMAN (UNIT II), MIDC FILM- CONTAIN
PATALGANGA, DISTRICT- COATED ER
RAIGAD MAHARASHTRA, TABLETS
410220 INDIA
3240 NDA/MAL/H MYLAN KIMSY MEDS MYHEP DACLATASVIR 60MG + MYLAN LABORATORIES INDIA ORAL SOLID 1.0X28.0 1/31/2018
DP/7012 LABORATORIE LTD DVIR + 400MG LIMITED-F- 4 & F-12, ORDINARY TABLET
S LIMITED SOFOSBUVIR MIDC, MALEGAON, FILM- BOTTLE
SINNAR, NASHIK -422 113 COATED
MAHARASHTRA, INDIA. TABLETS
3241 NDA/MAL/H PINNACLE METRO AZITHRAA AZITHROMYCI 500MG PINNACLE LIFE SCIENCE INDIA ORAL SOLID 1.0X1.0X3 11/29/2017
DP/7013 LIFE SCIENCE PHARMACEUTIC 500 N PVT LTD-KHASRA NO. ORDINARY .0 TABLET
PVT. LTD. ALS LIMITED 1328-1330, VILLAG FILM- BLISTER
MANPURA, TEHSIL, BADDI, COATED
3242 NDA/MAL/H PINNACLE METRO ACEAAR ACECLOFENA 100MG PINNACLE LIFE SCIENCE INDIA ORAL SOLID 1.0X3.0X1 11/29/2017
DP/7014 LIFE SCIENCE PHARMACEUTIC 100 TABLET C PVT LTD-KHASRA NO. ORDINARY 0.0
MANPURA, TEHSIL, BADDI, COATED STRIP
3243 NDA/MAL/H KOPRAN TATA UGANDA LOKIT OMEPRAZOLE 20MG KOPRAN LTD-VILLAGE INDIA ORAL SOLID 1.0X10.0X 1/31/2018
DP/7015 LIMITED LIMITED SAVROLI TAL KHARAPUR ORDINARY 10.0
DIST RAIGAD 410 202 CAPSULES CAPSULE
BLISTER
3244 NDA/MAL/H LABORATORY HARLEYS AXYLIN AMPICILLIN 125MG + LABORATORY & ALLIED KENYA ORAL LIQUID 1.0X100.0 8/28/2019
DP/7018 & ALLIED LTD UGANDA TRIHYDRATE 125MG LTD -PLOT 209/10349 OFF ORDINARY ML
LIMITED + MOMBASA ROAD DRY BOTTLE
CLOXACILLIN SUSPENSION
SODIUM S/SYRUPS/D
ROPS
3245 NDA/MAL/H LABORATORY HARLEYS LECOTRIM SULFAMETHO 200MG + LABORATORY & ALLIED KENYA ORAL LIQUID 1.0X50.0 8/28/2019
DP/7019 & ALLIED LTD UGANDA XAZOLE + 40MG / LTD -PLOT 209/10349 OFF ORDINARY ML
LIMITED TRIMETHOPRI 5ML MOMBASA ROAD LIQUIDS BOTTLE
M
3246 NDA/MAL/H LABORATORY HARLEYS KEMOXYL AMOXICILLIN 250MG LABORATORY AND ALLIED KENYA ORAL SOLID 1.0X10.0X 8/28/2019
DP/7020 & ALLIED LTD UGANDA 250 DT TRIHYDRATE LTD ..-PLOT 209/10349, ORDINARY 10.0
LIMITED OFF MOMBASA ROAD SOLUBLE TABLET
TABLETS BLISTER
3247 NDA/MAL/H PINNACLE METRO PINNOFEC ACECLOFENA 100MG+50 PINNACLE LIFE SCIENCE INDIA ORAL SOLID 1.0X3.0X1 11/29/2017
DP/7021 LIFE SCIENCE PHARMACEUTIC PLUS C+PARACETA 0MG PVT LTD-KHASRA NO. ORDINARY 0.0
PVT. LTD. ALS LIMITED MOL 1328-1330, VILLAG TABLETS TABLET
MANPURA, TEHSIL, BADDI, BLISTER
DIST. SOLAN (HP)
3248 NDA/MAL/H PINNACLE METRO PINNAFLA DICLOFENAC 50MG+500 PINNACLE LIFE SCIENCE INDIA ORAL SOLID 1.0X10.0X 7/1/2017
DP/7022 LIFE SCIENCE PHARMACEUTIC M PLUS SODIUM+PAR MG PVT LTD-KHASRA NO. ORDINARY 10.0
PVT. LTD. ALS LIMITED ACETAMOL 1328-1330, VILLAG TABLETS TABLET
MANPURA, TEHSIL, BADDI, BLISTER
DIST. SOLAN (HP)
3249 NDA/MAL/H EXPHAR SA. SURGIPHARM VERZOL ALBENDAZOL 200 MG / 5 GRACURE INDIA ORAL LIQUID 1.0X1.0X1 3/28/2018
DP/7023 (U) LIMITED ORAL E ML PHARMACEUTICAL LTD-E- ORDINARY 0.0 ML
SUSPENSIO 1105, RIICO IND. AREA, SUSPENSION BOTTLE,1.
N PHASE III, BHIWADI, S 0X20.0X10
DISTRICT ALWAR .0 ML
(RAJASTHAN) BOTTLE
3250 NDA/MAL/H EXPHAR SA. SURGIPHARM MICOZAL KETOCONAZO 2%W/W GRACURE INDIA TOPICAL 1.0X15.0 11/29/2017
DP/7024 (U) LIMITED LE PHARMACEUTICAL LTD-E- EXTERNAL G TUBE
1105, RIICO IND. AREA, CREAMS
PHASE III, BHIWADI,
DISTRICT ALWAR
(RAJASTHAN)
3251 NDA/MAL/H KOTRA UNITED AXCEL OXYMETAZOL 0.05%W/V KOTRA PHARMA (M) MALAYSIA NASAL 1.0X1.0X1 8/28/2019
DP/7026 PHARMA (M) HEALTHCARE OXYMETAZ INE SDN.BHD,-1, 2 & 3, JALAN TOPICAL 0.0 ML
SDN,BHD DISTRIBUTORS OLINE HYDROCHLOR TTC 12, CHENG SPRAYS BOTTLE
LTD NASAL IDE INDUSTRIAL ESTATE, WITHOUT
SPRAY 75250 MELAKA GAS
3252 NDA/MAL/H JAMJOOM MU PHARMA CO DEXAFLOX OFLOXACIN + 3MG + JAMJOOM SAUDI OPHTHALMI 1.0X5.0 9/2/2019
DP/7028 PHARMACEUT -SMC LIMITED DEXAMETHAS 1MG PER PHARMACEUTICALS CO.- ARABIA C LIQUIDS ML
ICALS ONE ML PLOT NO. ME 1:3, PHASE BOTTLE
COMPANY V, INDUSTRIAL CITY, P.O.
BOX 6267 JEEDAH
3253 NDA/MAL/H ZIM GITTOES LIPIZAR 20 ATORVASTATI 20MG ZIM LABORATORIES LTD-B- INDIA ORAL SOLID 1.0X3.0X1 3/28/2018
DP/7029 LABORATORIE PHARMACEUTIC N CALCIUM 21/22, M.I.D.C. AREA, ORDINARY 0.0
S LTD ALS LIMITED (TRIHYDRATE KALMESHWAR – 441501, FILM- TABLET
) DIST. NAGPUR, COATED BLISTER
MAHARASHTRA, TABLETS
3254 NDA/MAL/H MEDLEY MEDVIN O2 OFLOXACIN + 50MG + MEDLEY INDIA ORAL LIQUID 1.0X30.0 8/28/2019
DP/7037 PHARMACEUT PHARMA ORNIDAZOLE 125MG PHARMACEUTICALS LTD- ORDINARY ML
ICALS LTD LIMITED LANE 03, PHASE 1, SIDCO SYRUPS BOTTLE
INDUSTRIAL COMPLEX,
BARI BRAHMANA JAMMU
181133
3255 NDA/MAL/H MEDLEY MEDVIN O2 OFLOXACIN + 200MG + MEDLEY INDIA ORAL SOLID 1.0X10.0X 8/28/2019
DP/7039 PHARMACEUT PHARMA ORNIDAZOLE 500MG PHARMACEUTICALS LTD- ORDINARY 10.0
ICALS LTD LIMITED LANE 03, PHASE 1, SIDCO FILM- TABLET
INDUSTRIAL COMPLEX, COATED BLISTER
BARI BRAHMANA JAMMU TABLETS
181133
3256 NDA/MAL/H MEDLEY MEDVIN R.B.TONE FERROUS 129.5MG + MEDLEY INDIA ORAL LIQUID 1.0X200.0 8/28/2019
DP/7042 PHARMACEUT PHARMA SYRUP GLUCONATE .25MG + PHARMACEUTICALS LTD..- ORDINARY ML
ICALS LTD LIMITED + FOLIC ACID 75MG PLOT NO. 18 & 19, SURVEY SYRUPS BOTTLE
+ CALCIUM +1.25MCG NO. 378 / 7 & 8 & 379 /
LACTATE + 2& 3, ZARI CAUSEWAY
VITAMIN B12 ROAD, KACHIGAM,
DAMAN (U.T) 396210 -
INDIA
3257 NDA/MAL/H MEDLEY MEDVIN R.B. TONE FERROUS 259MG + MEDLEY INDIA ORAL SOLID 1.0X5.0X2 8/28/2019
DP/7044 PHARMACEUT PHARMA HAEMATINI GLUCONATE 0.5MG + PHARMACEUTICALS LTD..- ORDINARY .0X15.0
ICALS LTD LIMITED C CAPSULES + FOLIC ACID 100MG + PLOT NO. 18 & 19, SURVEY CAPSULES CAPSULE
+ CALCIUM 33MG + NO. 378 / 7 & 8 & 379 / BLISTER
LACTATE + 2.5MG 2& 3, ZARI CAUSEWAY
ZINC SULFATE ROAD, KACHIGAM,
+ VITAMIN DAMAN (U.T) 396210 -
B12 INDIA
3258 NDA/MAL/H HOVID BHD UNITED KETOVID KETOCONAZO 2%W/W HOVID BHD -121 ,JALAN MALAYSIA TOPICAL 1.0X15.0 7/1/2017
DP/7053 HEALTHCARE CREAM LE TUNKU ABDUL RAHMAN , EXTERNAL G TUBE
DISTRIBUTORS 30010 IPOH , PERAK , CREAMS
LTD MALAYSIA
3259 NDA/MAL/H HOVID BHD UNITED VIREST 400 ACICLOVIR 400MG HOVID BHD -121 ,JALAN MALAYSIA ORAL SOLID 5.0X5.0 1/31/2018
DP/7055 HEALTHCARE TUNKU ABDUL RAHMAN , ORDINARY TABLET
DISTRIBUTORS 30010 IPOH , PERAK , TABLETS BLISTER
LTD MALAYSIA
3260 NDA/MAL/H HOVID BHD UNITED VIREST ACICLOVIR 5%W/W HOVID BHD -121 ,JALAN MALAYSIA TOPICAL 1.0X5.0 G 7/1/2017
DP/7057 HEALTHCARE CREAM 5% TUNKU ABDUL RAHMAN , EXTERNAL TUBE
DISTRIBUTORS 30010 IPOH , PERAK , CREAMS
LTD MALAYSIA
3261 NDA/MAL/H HOVID BHD UNITED NEURAN GABAPENTIN 300MG HOVID BERHAD,-LOT MALAYSIA ORAL SOLID 1.0X10.0X 8/28/2019
DP/7058 HEALTHCARE 300 MG 56442, 7 1/2 MILES JALAN ORDINARY 10.0
DISTRIBUTORS CAPSULE IPOH/CHEMOR 31200, CAPSULES CAPSULE
LTD CHEMOR PERAK HOVID BLISTER
BHD -121 ,JALAN TUNKU
ABDUL RAHMAN , 30010
IPOH , PERAK , MALAYSIA
3262 NDA/MAL/H HOVID BHD UNITED GRISEOFUL GRISEOFULVI 500MG HOVID BHD-LOT 56442, MALAYSIA ORAL SOLID 1.0X10.0X 1/31/2018
DP/7063 HEALTHCARE VIN 500MG N 7.5 MILE JALAN ORDINARY 10.0
DISTRIBUTORS FILM- IPOH/CHEMO 31200 FILM- TABLET
LTD COATED CHEMOR, PERAK COATED BLISTER
TABLET MALAYSIA TABLETS
3263 NDA/MAL/H JAMJOOM MU PHARMA CO BRIMO BRIMONIDIN 2%W/V JAMJOOM SAUDI OPHTHALMI 1.0X5.0 9/2/2019
DP/7065 PHARMACEUT -SMC LIMITED E TARTRATE PHARMACEUTICALS CO.- ARABIA C LIQUIDS ML
ICALS PLOT NO. ME 1:3, PHASE BOTTLE
BOX 6267 JEEDAH
3264 NDA/MAL/H MERIDIAN ABACUS SUPPOL PARACETAM 125MG MERIDIAN ENTERPRISES INDIA RECTAL 1.0X2.0X5 8/28/2019
DP/7067 ENTERPRISES PHARMA 125 OL PVT. LTD--PLOT NO. 418, SYSTEMIC .0
GUJARAT,INDIA
3265 NDA/MAL/H MERIDIAN ABACUS FENSUPP- DICLOFENAC 25MG MERIDIAN ENTERPRISES INDIA RECTAL 1.0X1.0X5 8/28/2019
DP/7068 ENTERPRISES PHARMA 25 SODIUM PVT. LTD--PLOT NO. 418, SYSTEMIC .0
GUJARAT,INDIA
3266 NDA/MAL/H JAMJOOM MU PHARMA CO AMVASC 10 AMLODIPINE 10MG JAMJOOM SAUDI ORAL SOLID 1.0X3.0X1 9/2/2019
DP/7069 PHARMACEUT -SMC LIMITED BESYLATE PHARMACEUTICALS CO.- ARABIA ORDINARY 0.0
ICALS PLOT NO. ME 1:3, PHASE CAPSULES CAPSULE
COMPANY V, INDUSTRIAL CITY, P.O. BLISTER
BOX 6267 JEEDAH
3267 NDA/MAL/H HOVID BHD UNITED DIABETMIN METFORMIN 1000MG HOVID BERHAD (CHEMOR MALAYSIA ORAL SOLID 1.0X10.0X 1/31/2018
DP/7070 HEALTHCARE 1000 MG HYDROCHLOR SITE)--LOT 56442, 71/2, ORDINARY 10.0
DISTRIBUTORS FILM- IDE JALAN IPOH/CHEMOR FILM- TABLET
LTD COATED 31200, PERAK. MALAYSIA COATED BLISTER
TABLET TABLETS
3268 NDA/MAL/H CIPLA LTD. QUALITY FORACORT- FORMOTEROL 6MCG + CIPLA LIMITED-PLOT NO 9 INDIA LUNG 1.0X1.0X1 7/25/2018
DP/7071 CHEMICALS LTD - 200 FUMARATE 200MCG & 10, PHARMA ZONE, ADMINISTRA 20.0
HUMAN DIHYDRATE + PHASE II, INDORE SPECIAL TION METERED
BUDESONIDE ECONOMIC ZONE, METERED- DOSE
PITHAMPUR, DIST: DHAR, DOSE CANNISTE
MADHYA PRADESH – 454 POWDER R
775, INDIA. INHALER
3269 NDA/MAL/H JAMJOOM MU PHARMA CO AMVASC 5 AMLODIPINE 5MG JAMJOOM SAUDI ORAL SOLID 1.0X3.0X1 9/2/2019
DP/7072 PHARMACEUT -SMC LIMITED BESYLATE PHARMACEUTICALS CO.- ARABIA ORDINARY 0.0
ICALS PLOT NO. ME 1:3, PHASE CAPSULES CAPSULE
COMPANY V, INDUSTRIAL CITY, P.O. BLISTER
BOX 6267 JEEDAH
3270 NDA/MAL/H MINAPHARM SWASTIK NAUSILEX ALIZAPRIDE 50 MINAPHARM EGYPT PARENTERAL 1.0X3.0X2 9/2/2019
DP/7073 PHARMACEUT PHARMACEUTIC HYDROCHLOR MG/2ML PHARMACEUTICAL & ORDINARY .0 ML
ICAL & AL LTD IDE CHEMICAL INDUSTRIES- AMPOULES AMPOULE
CHEMICAL MINA STREET PARTS NO;
INDUSTRIES 15/4;16/4 INDUSTRIAL
ZONE A2-10TH OF
RAMADHAN CITY EGYPT
3271 NDA/MAL/H CIPLA LTD QUALITY FORACORT- FORMETEROL 6 CIPLA LIMITED-PLOT NO 9 INDIA LUNG 1.0X1.0X1 7/25/2018
DP/7074 CHEMICALS LTD - 100 FUMARATE MCG+100 & 10, PHARMA ZONE, ADMINISTRA 20.0
HUMAN DIHYDRATE + MCG PHASE II, INDORE SPECIAL TION METERED
775, INDIA. INHALER
3272 NDA/MAL/H HETERO AIVEEN (U) Q-TAB-200 QUETIAPINE 200MG HETERO LABS LIMITED INDIA ORAL SOLID 1.0X3.0X1 8/28/2019
DP/7075 DRUGS LTD LIMITED FUMARATE (UNIT V)-SY NO. 436,440, ORDINARY .0X8.0
441 & 458, APIIC TABLETS TABLET
FORMULATION SEZ, BLISTER
POLEPALLY (V),
JEDCHERLA (M),
MAHABOOBNAGAR,
DISTRICT ANDHRA
PRADESH 509301
3273 NDA/MAL/H CIPLA LTD QUALITY FORACORT- FORMOTEROL 6MCG + CIPLA LIMITED-PLOT NO 9 INDIA LUNG 1.0X1.0X1 7/25/2018
DP/7077 CHEMICALS LTD - 400 FUMARATE 400MCG & 10, PHARMA ZONE, ADMINISTRA 20.0
HUMAN DIHYDRATE + PHASE II, INDORE SPECIAL TION METERED
775, INDIA. INHALER
3274 NDA/MAL/H MYLAN KIMSY MEDS BENDAMUS BENDAMUSTI 100MG ALLY PHARMA OPTIONS INDIA PARENTERAL 1.0X50.0 1/13/2020
DP/7079 LABORATORIE LTD TINE NE PVT LTD..-J-7, MIDC, ORDINARY ML VIAL
S LIMITED HYDROCHLOR TARAPUR INDUSTRIAL DRY VIALS
IDE AREA,
BOISAR, DIST-THANE
DP/7080 DRUGS LTD LIMITED FUMARATE (UNIT V)-SY NO. 436,440, ORDINARY 0.0
POLEPALLY (V),
JEDCHERLA (M),
MAHABOOBNAGAR,
DISTRICT ANDHRA
PRADESH 509301
3276 NDA/MAL/H MYLAN KIMSY MEDS BENDAMUS BENDAMUSTI 25MG/VIA ALLY PHARMA OPTIONS INDIA PARENTERAL 1.0X20.0 1/13/2020
DP/7081 LABORATORIE LTD TINE NE L PVT LTD..-J-7, MIDC, ORDINARY ML VIAL
S LIMITED HYDROCHLOR TARAPUR INDUSTRIAL DRY VIALS
IDE AREA,
BOISAR, DIST-THANE
3277 NDA/MAL/H MYLAN KIMSY MEDS VARNIL 20 VARDENAFIL 20MG MYLAN LABORATORIES INDIA ORAL SOLID 1.0X1.0X1 9/2/2019
DP/7082 LABORATORIE LTD HYDROCHLOR LTD-S-16&S17A, SURVEY ORDINARY 0.0
S LIMITED IDE NO.408(P),410(P), 458(P). TABLETS TABLET
SEZ TSIIC, GREEN BLISTER
INDUSTRIAL
PARK,POLEPALLY(V),JADC
HERLA(M),MAHABUBNAG
AR- 509 302,TELANGANA-
INDIA
3278 NDA/MAL/H HETERO AIVEEN (U) ETROBAX ETORICOXIB 90MG HETERO LABS PRIVATE INDIA ORAL SOLID 1.0X3.0X1 8/28/2019
DP/7083 DRUGS LTD LIMITED 90 LIMITED UNIT III-SURVEY ORDINARY 0.0
NO. 51, PLOT 22-110, TABLETS TABLET
INDUSTRIAL BLISTER
DEVELOPMENT AREA
(I.D.A) JEEDIMETLA,
HYDERABAD-500 055,
TELANGANA STATE
3279 NDA/MAL/H NABIQASIM JEET GABA 300 GABAPENTIN 300MG NABIQASIM INDUSTRIES PAKISTAN ORAL SOLID 1.0X2.0X1 8/28/2019
DP/7084 INDUSTRIES PHARMACEUTIC (PVT) LTD.-17/24, ORDINARY 0.0
(PVT) LTD. ALS LIMITED KORANGI INDUSTRIAL CAPSULES CAPSULE
AREA, KORANGI,KARACHI - BLISTER
PAKISTAN
3280 NDA/MAL/H NABIQASIM JEET DYSEN SECNIDAZOLE 750MG NABIQASIM INDUSTRIES PAKISTAN ORAL LIQUID 1.0X30.0 8/28/2019
DP/7085 INDUSTRIES PHARMACEUTIC SUSPENSIO (PVT) LTD.-17/24, ORDINARY ML
(PVT) LTD. ALS LIMITED N KORANGI INDUSTRIAL DRY BOTTLE
AREA, KORANGI,KARACHI - SUSPENSION
PAKISTAN S/SYRUPS/D
ROPS
DP/7087 DRUGS LTD LIMITED FUMARATE (UNIT V)-SY NO. 436,440, ORDINARY 0.0
POLEPALLY (V),
JEDCHERLA (M),
MAHABOOBNAGAR,
DISTRICT ANDHRA
PRADESH 509301
3282 NDA/MAL/H PINNACLE METRO PINNOX OFLOXACIN 200MG PINNACLE LIFE SCIENCE INDIA ORAL SOLID 1.0X10.0X 5/30/2018
DP/7088 LIFE SCIENCE PHARMACEUTIC 200 PVT LTD-KHASRA NO. ORDINARY 10.0
PVT. LTD ALS LIMITED 1328-1330, VILLAG FILM- TABLET
3283 NDA/MAL/H NABIQASIM JEET ES-LOPROT ESOMEPRAZO 40MG NABIQASIM INDUSTRIES PAKISTAN PARENTERAL 1.0X10.0 8/28/2019
DP/7089 INDUSTRIES PHARMACEUTIC LE SODIUM (PVT) LTD.-17/24, ORDINARY ML VIAL
(PVT) LTD. ALS LIMITED KORANGI INDUSTRIAL VIALS
AREA, KORANGI,KARACHI -
PAKISTAN
3284 NDA/MAL/H BHARAT ABACUS ENDOPROS CARBOPROST 125MCG/0. BHARAT SERUMS & INDIA PARENTERAL 1.0X1.0 1/31/2018
DP/7090 SERUMS AND PHARMA T TROMETHAM 5ML VACCINES LTD.-PLOT NO. ORDINARY VIAL
VACCINES LTD (AFRICA) INE K–27, JAMBIVILI VILLAGE, VIALS CARTON
LIMITED ANAND NAGAR,
ADDITIONAL M.I.D.C.,
AMBERNATH (EAST)-INDIA
3285 NDA/MAL/H PINNACLE METRO AARLEFLOX LEVOFLOXACI 500MG PINNACLE LIFE SCIENCE INDIA ORAL SOLID 1.0X10.0X 11/29/2017
DP/7091 LIFE SCIENCE PHARMACEUTIC 500 N PVT LTD-KHASRA NO. ORDINARY 10.0
PVT. LTD. ALS LIMITED TABLETS HEMIHYDRAT 1328-1330, VILLAG FILM- TABLET
E MANPURA, TEHSIL, BADDI, COATED BLISTER
3286 NDA/MAL/H NABIQASIM JEET PATMAC PANTOPRAZO 40MG NABIQASIM INDUSTRIES PAKISTAN PARENTERAL 1.0X10.0 8/28/2019
DP/7092 INDUSTRIES PHARMACEUTIC LE SODIUM (PVT) LTD.-17/24, ORDINARY ML VIAL
(PVT) LTD. ALS LIMITED KORANGI INDUSTRIAL VIALS
AREA, KORANGI,KARACHI -
PAKISTAN
3287 NDA/MAL/H NABIQASIM JEET GLANDIN- DINOPROSTO 2MG NABIQASIM INDUSTRIES PAKISTAN TOPICAL 1.0X3.0 G 8/28/2019
DP/7094 INDUSTRIES PHARMACEUTIC E2 NE (PVT) LTD.-17/24, EXTERNAL PRE-
(PVT) LTD. ALS LIMITED KORANGI INDUSTRIAL GELS AND FILLED
AREA, KORANGI,KARACHI - SOLS SYRINGE
PAKISTAN
3288 NDA/MAL/H PLANET PLANET FREMOL PARACETAM 500MG + FREDUN INDIA ORAL SOLID 1.0X10.0X 11/27/2019
DP/7095 PHARMACEUT PHARMACEUTIC EXTRA OL + 65MG PHARMACEUTICALS ORDINARY 10.0
ICALS ALS UGANDA CAFFEINE LIMITED-14,15,16, TABLETS TABLET
UGANDA LTD LTD ZORABIAN INDUSTRIAL BLISTER
404
3289 NDA/MAL/H UNOSOURCE ABACUS ACEFORCE ACECLOFENA 100MG+32 AKUMS DRUGS AND INDIA ORAL SOLID 1.0X10.0X 1/31/2018
DP/7098 PHARMA LTD. PHARMA SP C+PARACETA 5MG+15M PHARMACEUTICALS LTD- ORDINARY 10.0
(AFRICA) MOL+SERRAT G PLANT-1 PLOT NO.19, FILM- TABLET
LIMITED IOPEPTIDASE 20&21 SECTOR-6A, 11E, COATED BLISTER
SIDCUL, RAHIPUR DISTT; TABLETS
HARIDWAR, 249403,
(UTTRAKHAND) INDIA
3290 NDA/MAL/H MYLAN NORVIK MYGESTY MEDROXYPR 150MG/ML MYLAN LABORATORIES INDIA PARENTERAL 1.0X12.0X 11/27/2019
DP/7099 LABORATORIE ENTERPRISES OGESTERONE LIMITED-PLOT NO. 20 & ORDINARY 1.0 ML
S LIMITED LIMITED ACETATE 21, PHARMEZ, SARKHEJ - VIALS VIAL,1.0X
BAVLA, NATIONAL 25.0X1.0
HIGHWAY NO. 8 - A, NEAR ML VIAL
VILLAGE - MATODA, TAL -
SANAND, DIST.,
AHMEDABAD - 382213
3291 NDA/MAL/H RENE RENE ASTHAREN SALBUTAMOL 4MG RENE INDUSTRIES LIMITED- UGANDA ORAL SOLID 1.0X10.0X 7/1/2016
DP/7101 INDUSTRIES INDUSTRIES SULPHATE PLOT 680 KAMULI- KIREKA ORDINARY 10.0
LTD LIMITED TABLETS TABLET
BLISTER
3292 NDA/MAL/H RENE RENE REPRAZINE CHLORPROM 100MG RENE INDUSTRIES LIMITED- UGANDA ORAL SOLID 1.0X10.0X 7/1/2016
DP/7102 INDUSTRIES INDUSTRIES AZINE PLOT 680 KAMULI- KIREKA ORDINARY 10.0
LTD LIMITED HYDROCHLOR FILM- TABLET
IDE COATED BLISTER
TABLETS
3293 NDA/MAL/H MACARTHYS LABOREX CAFFEINE CAFFEINE 10MG/ML MACARTHYS UNITED PARENTERAL 1.0X10.0X 11/27/2019
DP/7103 LABORATORIE UGANDA CITRATE CITRATE LABORATORIES LIMITED KINGDOM ORDINARY 1.0 ML
S LTD LIMITED 10MG/ ML T\A MARTINDALE AMPOULES AMPOULE
SOLUTION PHARMA-BAMPTON
FOR ROAD, ROMFORD, ESSEX
INJECTION RM3 8UG,
3294 NDA/MAL/H CACHET ASTRA PHARMA TRAMACET ACETAMINOP 325MG+37 CACHET INDIA ORAL SOLID 1.0X10.0 7/1/2017
DP/7105 PHARMACEUT (U) LIMITED AL TABLETS HEN .5MG PHARMACEUTICALS PVT ORDINARY TABLET
ICALS PVT +TRAMADOL LTD-VILLAGE AND POST FILM- BLISTER
LIMITED HYDROCHLOR THANA BADDI TEHSIL COATED
IDE NALAGARH SOLAN TABLETS
DISTRICT HIMACHAL
PRADESH 173 205
3295 NDA/MAL/H RENE RENE REVIVE GLUCOSE 13.5G + RENE INDUSTRIES LIMITED- UGANDA ORAL LIQUID 1.0X1.0 7/1/2016
DP/7106 INDUSTRIES INDUSTRIES ANHYDROUS 2.9G + PLOT 680 KAMULI- KIREKA ORDINARY SACHET
LTD LIMITED + TRISODIUM 2.6G + SOLUBLE CARTON
CITRATE 1.5G POWDERS
DIHYDRATE +
SODIUM
CHLORIDE +
POTASSIUM
CHLORIDE
3296 NDA/MAL/H MACLEODS NORVIK FEBUMAC FEBUXOSTAT 40 MG MACLEODS INDIA ORAL SOLID 1.0X1.0X1 3/27/2019
ICALS LTD LIMITED LIMITED -BLOCK-N2 FILM- TABLET
VILLAGE THEDA POST COATED BLISTER,1.
OFFICE LODHIMAJRA TABLETS 0X3.0X10.
TEHSIL BADDI DISTRICT 0 TABLET
SOLAN HIMACHAL BLISTER,1.
PRADESH – 174101 0X10.0X10
INDIA .0 TABLET
BLISTER
3297 NDA/MAL/H MANKIND TATA UGANDA BRUTAFLA ETORICOXIB 60MG MANKIND PHARMA LTD, INDIA ORAL SOLID 1.0X3.0X1 11/27/2019
DP/7109 PHARMA LIMITED M-60 UNIT II ,-VILLAGE- ORDINARY 0.0
LIMITED KISHANPURA, PAONTA TABLETS TABLET
SAHIB, DIST. SIRMOUR, HP BLISTER
3298 NDA/MAL/H THE UNITED WIDE UNIFED TRIPROLIDINE 1.25MG + UNITED JORDAN ORAL LIQUID 1.0X120.0 11/27/2019
DP/7110 PHARMACEUT SPECTRUM EXTRA HYDROCHLOR 10MG + PHARMACEUTICALS ORDINARY ML
ICALS MFG, ENTERPRISES SYRUP IDE + 7.5MG + MANUFACTURING LTD CO- SYRUPS BOTTLE
CO. LTD, (U) LIMITED 120ML PSEUDOEPHE 50MG/5ML AL- RAGEEM, SAHAB, P.O
HYDROCHLOR JORDAN
IDE +
DEXTROMET
HORPHAN +
GUAIFENESIN
3299 NDA/MAL/H HETERO AIVEEN (U) ETROBAX ETORICOXIB 60MG HETERO LABS PRIVATE INDIA ORAL SOLID 1.0X3.0X1 8/28/2019
DP/7112 DRUGS LTD LIMITED 60 LIMITED UNIT III-SURVEY ORDINARY 0.0
NO. 51, PLOT 22-110, TABLETS TABLET
INDUSTRIAL BLISTER
DEVELOPMENT AREA
(I.D.A) JEEDIMETLA,
HYDERABAD-500 055,
TELANGANA STATE
3300 NDA/MAL/H HETERO AIVEEN (U) RILAST 500 RITUXIMAB 500MG/50 HETERO LABS LIMITED INDIA PARENTERAL 1.0X50.0 8/28/2019
DP/7113 DRUGS LTD LIMITED ML (UNIT V)-SY NO. 436,440, ORDINARY ML VIAL
441 & 458, APIIC VIALS
FORMULATION SEZ,
POLEPALLY (V),
JEDCHERLA (M),
MAHABOOBNAGAR,
DISTRICT ANDHRA
PRADESH 509301
3301 NDA/MAL/H HETERO AIVEEN (U) RILAST 100 RITUXIMAB 100MG/10 HETERO LABS LIMITED INDIA PARENTERAL 1.0X10.0 8/28/2019
DP/7114 DRUGS LTD LIMITED ML (UNIT V)-SY NO. 436,440, ORDINARY ML VIAL
441 & 458, APIIC VIALS
FORMULATION SEZ,
POLEPALLY (V),
JEDCHERLA (M),
MAHABOOBNAGAR,
DISTRICT ANDHRA
PRADESH 509301
3302 NDA/MAL/H INTAS, NORVIK TELTAS-40 TELMISARTA (40+12.5) INTAS PHARMACEUTICALS INDIA ORAL SOLID 1.0X3.0X1 11/7/2018
DP/7115 PHARMACEUT ENTERPRISES H N MG LIMITED -CAMP ROAD, ORDINARY 0.0
ICALS LTD LIMITED +HYDROCHLO SELAQUI- TABLETS TABLET
ROTHIAZIDE 248197,DEHRADUN BLISTER
UTTARAKHAND, INDIA
3303 NDA/MAL/H THE UNITED WIDE UNIFED TRIPROLIDINE 1.25MG + UNITED JORDAN ORAL LIQUID 1.0X120.0 11/27/2019
DP/7116 PHARMACEUT SPECTRUM SYRUP HYDROCHLOR 30MG/5ML PHARMACEUTICALS ORDINARY ML
ICALS MFG, ENTERPRISES 120ML IDE + MANUFACTURING LTD CO- SYRUPS BOTTLE
CO. LTD, (U) LIMITED PSEUDOEPHE AL- RAGEEM, SAHAB, P.O
HYDROCHLOR JORDAN
IDE
3304 NDA/MAL/H THE UNITED WIDE UNIFED TRIPROLIDINE 2.5MG+60 UNITED JORDAN ORAL SOLID 1.0X2.0X1 11/27/2019
DP/7117 PHARMACEUT SPECTRUM TABLETS HYDROCHLOR MG PHARMACEUTICALS ORDINARY 0.0
ICALS MFG, ENTERPRISES IDE + MANUFACTURING LTD CO- TABLETS TABLET
CO. LTD, (U) LIMITED PSEUDOEPHE AL- RAGEEM, SAHAB, P.O BLISTER
HYDROCHLOR JORDAN
IDE
3305 NDA/MAL/H MANKIND TATA UGANDA BRUTAFLA ETORICOXIB 90MG MANKIND PHARMA LTD, INDIA ORAL SOLID 1.0X3.0X1 11/27/2019
DP/7118 PHARMA LIMITED M-90 UNIT II ,-VILLAGE- ORDINARY 0.0
LIMITED KISHANPURA, PAONTA TABLETS TABLET
SAHIB, DIST. SIRMOUR, HP BLISTER
3306 NDA/MAL/H MICRO LABS PHILLIPS OLMAT-40 OLMESARTAN 40MG + MICRO LABS LIMITED .,-92, INDIA ORAL SOLID 1.0X3.0X1 11/27/2019
DP/7119 LTD PHARMACEUTIC H MEDOXOMIL 12.5MG SIPCOT, HOSUR 635126 ORDINARY 0.0
ALS (UGANDA) + TABLETS TABLET
LIMITED HYDROCHLOR BLISTER
OTHIAZIDE
3307 NDA/MAL/H BESINS SURGIPHARM ANDROGEL TESTOSTERO 16.2MG/G BESINS MANUFACTURING BELGIUM TOPICAL 1.0X88.0 11/27/2019
DP/7120 HEALTHCARE (U) LIMITED NE BELGIUM (BMB)-GROOT EXTERNAL G
BENELUX SA BIJGAARDENSTRAAT, 128. EMULSION CANNISTE
1620 GELS R
3308 NDA/MAL/H SUNRISE ROYAL PHARMA ATERISE- ATENOLOL 100MG SUNRISE INTERNATIONAL INDIA ORAL SOLID 1.0X10.0X 8/29/2019
DP/7121 INTERNATION 2011 LIMITED 100 LABS LTD-PLOT NO. 100, ORDINARY 10.0
AL LABS LTD LANE-5, SECTOR-II, PHASE- TABLETS TABLET
II, IDA, CHERLAPALLY BLISTER
INDIA
3309 NDA/MAL/H SUNRISE ROYAL PHARMA ATERISE-50 ATENOLOL 50MG SUNRISE INTERNATIONAL INDIA ORAL SOLID 1.0X10.0X 8/29/2019
DP/7122 INTERNATION 2011 LIMITED LABS LTD-PLOT NO. 100, ORDINARY 10.0
INDIA
3310 NDA/MAL/H UNOSOURCE ESCORTS MARTINEZ MONTELUKAS 10MG AKUMS DRUGS AND INDIA ORAL SOLID 1.0X1.0X1 3/28/2018
DP/7123 PHARMA LTD. PHARMACEUTIC 10 T SODIUM PHARMACEUTICALS LTD- ORDINARY 0.0
ALS LIMITED PLANT-1 PLOT NO.19, FILM- TABLET
20&21 SECTOR-6A, 11E, COATED BLISTER,1.
SIDCUL, RAHIPUR DISTT; TABLETS 0X3.0X10.
HARIDWAR, 249403, 0 TABLET
(UTTRAKHAND) INDIA BLISTER
3311 NDA/MAL/H PHARCO WIDE VITAMIN E VITAMIN E 400 MG PHARCO EGYPT ORAL SOLID 1.0X2.0X1 7/1/2017
DP/7124 PHARMACEUT SPECTRUM 400 MG. PHARMACEUTICALS LTD- ORDINARY 2.0
ICALS ENTERPRISES KILO 31 ALEXANDRIA, OTHER CAPSULE
(U) LIMITED CAIRO DESERT ROAD, CAPSULES BLISTER
ALEXANDRIA EGYPT
3312 NDA/MAL/H SYNOKEM ABACUS I-FREE 72 LEVONORGES 1.5MG SYNOKEM INDIA ORAL SOLID 1.0X1.0X1 2/4/2019
DP/7125 PHARMACEUT PHARMA TREL PHARMACEUTICALS ORDINARY .0 TABLET
ICALS LIMITED (AFRICA) LIMITED -PLOT NO.- 35-36, FILM- BLISTER
LIMITED SECTOR-6A, IIE (SIDCUL), COATED
RANIPUR (BHEL) TABLETS
3313 NDA/MAL/H PT. SYDNA ECHO BRAIN-Q CITICOLINE 250MG/2 PT SYDNA FARMA-JL RC INDONESIA PARENTERAL 1.0X5.0X2 8/29/2019
DP/7126 FARMA PHARMACY (U) 250 MONOSODIU ML VETERAN NO.89- ORDINARY .0 ML
LIMITED M BINTARO,JARKATA, 12330, AMPOULES AMPOULE
INDONESIA
3314 NDA/MAL/H CIPLA LTD. QUALITY CASPOGIN CASPOFUNGI 50MG CIPLA LTD-UNIT IX, M-61, INDIA PARENTERAL 1.0X1.0 11/7/2018
DP/7127 CHEMICALS LTD - 50 N ACETATE M-62 & M-63, ORDINARY VIAL
HUMAN VERNA INDUSTRIAL DRY VIALS CARTON
ESTATE,
VERNA, SALCETTE
GOA 403 722
3315 NDA/MAL/H S K AGE ABACUS COTRIKANT- TRIMETHOPRI 800MG+16 S KANT HEALTHCARE LTD- INDIA ORAL SOLID 1.0X10.0X 9/26/2018
DP/7128 EXPORTS PHARMA 960 M+SULFAMET 0MG PLOT NO. 1802-1805, ORDINARY 10.0
(AFRICA) HOXAZOLE G.I.D.C. PHASE III, VAPI TABLETS TABLET
LIMITED 396 195. GUJARAT. BLISTER
3316 NDA/MAL/H SAKAR HARLEYS CETICAD CETIRIZINE 5MG/5ML SAKAR HEALTHCARE PVT INDIA ORAL LIQUID 1.0X60.0 8/29/2019
DP/7129 HEALTHCARE UGANDA DIHYDROCHL LTD-BLOCK NO. 10-13, NR. ORDINARY ML
LIMITED LIMITED ORIDE M.N DESAI PETRO PUMP, SYRUPS BOTTLE
SARKHEJ-BAVLA ROAD,
CHANGODAR, DIST:
AHMEDABAD-382213,
GUJARAT
3317 NDA/MAL/H CIPLA LTD. QUALITY CASPOGIN CASPOFUNGI 70MG CIPLA LTD-UNIT IX, M-61, INDIA PARENTERAL 1.0X1.0 11/7/2018
DP/7132 CHEMICALS LTD - 70 N ACETATE M-62 & M-63, ORDINARY VIAL
HUMAN VERNA INDUSTRIAL DRY VIALS CARTON
ESTATE,
VERNA, SALCETTE
GOA 403 722
3318 NDA/MAL/H LIPTIS EGYPT ERIS LTD WELLNESS DAY TABLET: DAY LIPTIS EGYPY FOR EGYPT ORAL SOLID 1.0X2.0X1 2/4/2019
DP/7133 FOR PARACETAM TABLET: PHARMACEUTICALS AND ORDINARY 0.0
PHARMACEUT OL + 325MG + MEDICAL PRODUCTS-PLOT FILM- TABLET
ICALS AND PSEUDOEPHE 30MG + NO. 2/B, 6TH INDUSTRIAL COATED BLISTER (5
MEDICAL DRINE 4.5MG | ZONE, 6TH OF OCTOBER TABLETS DAY
PRODUCTS HYDROCHLOR NIGHT CITY TABLETS +
IDE + TABLET : 5 NIGHT
DEXTROMET 500MG + TABLETS)
HORPHAN 30MG +
HYDROBROM 25MG
IDE | NIGHT
TABLET:
3319 NDA/MAL/H UNIQUE TATA UGANDA CILACAR CILNIDIPINE 10MG UNIQUE INDIA ORAL SOLID 1.0X10.0X 8/29/2019
DP/7135 PHARMACEUT LIMITED *10 PHARMACEUTICAL LABS ORDINARY 10.0
ICAL LIMITED. .-215-216, 216- FILM- TABLET
LABORATORIE 219, 304-308, GIDC COATED BLISTER
S. (A DIVISION PANOLI 394116-GUJARAT TABLETS
OF J.B.
CHEMICALS
AND
PHARMACEUT
ICALS LTD)
3320 NDA/MAL/H CARITAS REDDYS 5% DEXTROSE 5%W/V + SICHUAN KELUN CHINA PARENTERAL 1.0X500.0 8/29/2019
DP/7137 HEALTHCARE PHARMA DEXTROSE MONOHYDRA 0.9%W/V PHARMACEUTICAL CO., ORDINARY ML
PVT. LTD LIMITED AND 0.9% TE + SODIUM LTD-SOUTH OF NO.2, INFUSION BOTTLE
SODIUM CHLORIDE XINDU SATELLITE CITY, VIALS/BOTTL
CHLORIDE INDUSTRIAL ES
INJECTION DEVELOPMENT ZONE
CHENGDU SICHUAN
PROVINCE 610500, P .R
CHINA PEOPLE’S
REPULBIC OF CHINA
3321 NDA/MAL/H NATIONAL ANDYCO NETFORMI METFORMIN 500MG NATIONAL HEALTHCARE NEPAL ORAL SOLID 1.0X10.0X 8/29/2019
DP/7144 HEALTHCARE PHARMACY N-500 HYDROCHLOR PVT LTD.-VDC ORDINARY 10.0
PVT LTD (UGANDA) LTD IDE CHHATAPIPRA-3, BARA, TABLETS TABLET
BLISTER
3322 NDA/MAL/H AJANTA ABACUS BIMAT BIMATOPROS 0.03% W/V CIRON DRUGS & INDIA OPHTHALMI 1.0X1.0X3 5/30/2018
DP/7147 PHARMA PHARMA T PHARMACEUTICALS PVT C DROPS .0 ML
LIMITED (AFRICA) LTD-N-118, N-119 MIDC VIAL
LIMITED TARAPUR BOISAR DIST
THANE 401506
MAHARASHTRA INDIA
3323 NDA/MAL/H SUNRISE ROYAL PHARMA OMEPSUN OMEPRAZOLE 20 MG SUNRISE INTERNATIONAL INDIA ORAL SOLID 1.0X10.0X 7/25/2018
DP/7148 INTERNATION 2011 LIMITED LABS LTD.-PLOT NO. 100, ORDINARY 10.0
AL LABS LTD LANE 5, SECTOR II, PHASE OTHER CAPSULE
II CAPSULES BLISTER,1.
IDA CHERLAPALLY, 0X10.0X10
HYDERABAD-500 051 .0 TABLET
STRIP
3324 NDA/MAL/H AJANTA ABACUS OLOPAT OD OLOPATADIN 0.2% W/V CIRON DRUGS & INDIA OPHTHALMI 1.0X1.0X3 5/30/2018
DP/7149 PHARMA PHARMA E PHARMACEUTICALS PVT C DROPS .0 ML
LIMITED (AFRICA) HYDROCHLOR LTD-N-118, N-119 MIDC VIAL
LIMITED IDE TARAPUR BOISAR DIST
THANE 401506
MAHARASHTRA INDIA
3325 NDA/MAL/H SAKAR ROYAL PHARMA SEFIXI - SB CEFTRIAXONE 1000 MG SAKAR HEALTHCARE INDIA PARENTERAL 1.0X10.0 8/29/2019
DP/7150 HEALTHCARE 2011 LIMITED 1500 SODIUM +500MG LIMITED-BLOCK NO. 10-13, ORDINARY ML VIAL +
LIMITED +SULBACTAM SARKHEJ-BAVLA VIALS 1X10ML
SODIUM HIGHWAY, FFS
VILL: CHANGODAR, DIST: PLASTIC
AHMEDABAD-382213, BOTTLE
GUJARAT – INDIA. FOR WFI
3326 NDA/MAL/H AJANTA ABACUS APDROPS MOXIFLOXACI 5MG+1MG CIRON DRUGS & INDIA OPHTHALMI 1.0X1.0X5 5/30/2018
DP/7151 PHARMA PHARMA DX N /ML PHARMACEUTICALS PVT C DROPS .0 ML
LIMITED (AFRICA) HYDROCHLOR LTD-N-118, N-119 MIDC VIAL
LIMITED IDE + TARAPUR BOISAR DIST
DEXAMETHAS THANE 401506
ONE SODIUM MAHARASHTRA INDIA
PHOSPHATE
3327 NDA/MAL/H ABARIS ROYAL PHARMA CIPROFLOX CIPROFLOXAC 2MG/ML ABARIS HEALTHCARE PVT INDIA PARENTERAL 1.0X100.0 11/29/2017
DP/7154 HEALTHCARE 2011 LIMITED ACIN IN LTD - -SURVEY NO. 1407- ORDINARY ML
PVT. LTD HYDROCHL HYDROCHLOR 11, VILLAGE RAJPUR, INFUSION BOTTLE
ORIDE IDE TALUKA KADI DIST. VIALS/BOTTL
MEHSANA, GUJARAT- ES
382740
3328 NDA/MAL/H S K AGE ABACUS METFORMI METFORMIN 500MG S KANT HEALTHCARE LTD- INDIA ORAL SOLID 1.0X10.0X 8/29/2019
DP/7156 EXPORTS PHARMA N HYDROCHLOR PLOT NO. 1805, G.I.D.C ORDINARY 10.0
(AFRICA) EXTENDED IDE PHASE III, VAPI 396195, TABLETS TABLET
LIMITED RELEASE GUJARAT BLISTER
3329 NDA/MAL/H CIPLA LTD. QUALITY LINEZOLID LINEZOLID 600MG CIPLA LIMITED-PLOT NO 9 INDIA ORAL SOLID 1.0X2.0X1 1/31/2018
DP/7157 CHEMICALS LTD - TABLETS & 10, PHARMA ZONE, ORDINARY 0.0
HUMAN 600MG PHASE II, INDORE SPECIAL FILM- TABLET
ECONOMIC ZONE, COATED BOTTLE,1.
PITHAMPUR, DIST: DHAR, TABLETS 0X20.0
MADHYA PRADESH – 454 TABLET
775, INDIA. CONTAIN
ER
3330 NDA/MAL/H ZHUHAI SWASTIK KIN-CEF CEFTRIAXONE 1G ZHUHAI KINHOO CHINA PARENTERAL 1.0X1.0 G 8/29/2019
DP/7158 KINHOO PHARMACEUTIC SODIUM PHARMACEUTICAL CO. ORDINARY VIAL
PHARMACEUT AL LTD LTD-BIO INDUSTRY ZONE, DRY VIALS
ICAL CO., LTD GOLDEN COAST, ZHUHAA,
GUANGODONG
3331 NDA/MAL/H ACG CIPLA QUALITY TEXAVIR TENOFOVIR 300MG CIPLA QUALITY CHEMICAL UGANDA ORAL SOLID 1.0X30.0 7/1/2017
DP/7162 PHARMAPACK CHEMICAL DISOPROXIL INDUSTRIES LIMITED-PLOT ORDINARY TABLET
PVT. LTD INDUSTRIES FUMARATE 1-7, LUZIRA FILM- BOTTLE
LIMITED COATED
TABLETS
3332 NDA/MAL/H TRIVENI AIVEEN (U) STODIL LOPERAMIDE 2MG TRIVENI FORMULATIONS INDIA ORAL SOLID 1.0X10.0X 8/29/2019
DP/7163 FORMULATIO LIMITED HYDROCHLOR LTD-PLOT NO. ORDINARY 10.0
NS LIMITED IDE 52,53,54,63,62,64 ALEAP CAPSULES CAPSULE
3333 NDA/MAL/H TRIVENI AIVEEN (U) ERYMAC ERYTHROMYC 250MG TRIVENI FORMULATIONS INDIA ORAL SOLID 1.0X10.0X 8/29/2019
DP/7165 FORMULATIO LIMITED IN STEARATE LTD-PLOT NO. ORDINARY 10.0
NS LIMITED 52,53,54,63,62,64 ALEAP TABLETS TABLET
3334 NDA/MAL/H SPARSH BIO- ABACUS SPOTCLAV AMOXICILLIN 200MG + SPARSH BIO-TECH INDIA ORAL LIQUID 1.0X100.0 8/29/2019
DP/7167 TECH PHARMA DS TRIHYDRATE 28.5MG PRIVATE LIMITED,.-PLOT ORDINARY ML
PVT.LTD. (AFRICA) + PER 5ML NO.1, SURVEY NO. SUSPENSION BOTTLE
LIMITED CLAVULANAT 242/243/244, VILLAGE S
E LAKHABVAD, JAMNAGAR
361006
3335 NDA/MAL/H CARITAS REDDYS METRONID METRONIDAZ 0.5% W/V SICHUAN KELUN INDIA PARENTERAL 1.0X100.0 8/29/2019
DP/7168 HEALTHCARE PHARMA AZOLE OLE PHARMACEUTICAL CO., ORDINARY ML
PVT. LTD LIMITED LTD-SOUTH OF NO.2, INFUSION BOTTLE
XINDU SATELLITE CITY, VIALS/BOTTL
INDUSTRIAL ES
DEVELOPMENT ZONE
CHENGDU SICHUAN
PROVINCE 610500, P .R
CHINA PEOPLE’S
REPULBIC OF CHINA
3336 NDA/MAL/H WOCKHARD ROYAL PHARMA PHYTON PIPERACILLIN 2.0G + ZEISS PHARMACEUTICALS INDIA PARENTERAL 1.0X1.0 G 8/29/2019
DP/7169 LTD 2011 LIMITED 2.25G + 0.25G PVT LTD - -PLOT 72, EPIP, ORDINARY VIAL +
TAZOBACTAM PHASE 1, JHARMAJRI DRY VIALS 1X20ML
BADDI, 173205, DIST: WFI
SOLAN HIMACHAL AMPOULE
PRADESH, INDIA
3337 NDA/MAL/H WOCKHARD ROYAL PHARMA PHYTON PIPERACILLIN 4.0G + ZEISS PHARMACEUTICALS INDIA PARENTERAL 1.0X1.0 8/29/2019
DP/7170 LTD 2011 LIMITED 4.5G + 0.5G PVT LTD - -PLOT 72, EPIP, ORDINARY VIAL
TAZOBACTAM PHASE 1, JHARMAJRI DRY VIALS CARTON
BADDI, 173205, DIST: +1X20ML
SOLAN HIMACHAL WFI
PRADESH, INDIA AMPOULE
3338 NDA/MAL/H WOCKHARD ROYAL PHARMA MERIMIX MEROPENEM 1G + 0.5G ZEISS PHARMACEUTICALS INDIA PARENTERAL 1.0X1.0 8/29/2019
DP/7172 LTD 2011 LIMITED TRIHYDRATE PVT LTD - -PLOT 72, EPIP, ORDINARY VIAL
+ PHASE 1, JHARMAJRI DRY VIALS CARTON +
SULBACTAM BADDI, 173205, DIST: 1X20MLW
SODIUM SOLAN HIMACHAL FI
PRADESH, INDIA AMPOULE
3339 NDA/MAL/H MISSION JOINT MEDICAL TRICLOFEM MEDROXYPR 150MG/ML P.T. TUNGGAL IDAMAN INDONESIA PARENTERAL 1.0X4.0X5 8/29/2019
DP/7173 PHARMA A/S STORE (UPMB - ® OGESTERONE ABDI-JALAN ACHMAD ORDINARY .0 ML
UCMB) ACETATE YANI NO. 7 JAKARTA VIALS VIAL
TIMUR 13230
3340 NDA/MAL/H PSYCHOTROPI ABACUS TELPIL A TELMISARTA 40MG + PSYCHOTROPICS INDIA INDIA ORAL SOLID 1.0X3.0X1 7/25/2018
DP/7175 CS INDIA LTD PHARMA 40/5 MG N+ 5MG LTD-PLOT NO. 46 & 49 ORDINARY 0.0
(AFRICA) AMLODIPINE SECTOR -6A IIE SIDCUL TABLETS TABLET
LIMITED BESYLATE RANIPUR HARIDWAR BLISTER
249403 UTTARAKHAND
3341 NDA/MAL/H PT. SYDNA ECHO SYDNATRO ONDANSETR 4MG/2ML PT SYDNA FARMA-JL RC INDONESIA PARENTERAL 1.0X5.0X2 8/29/2019
DP/7177 FARMA PHARMACY (U) N-4 ON VETERAN NO.89- ORDINARY .0 ML
LIMITED HYDROCHLOR BINTARO,JARKATA, 12330, AMPOULES AMPOULE
IDE INDONESIA
3342 NDA/MAL/H PT. SYDNA ECHO SYDNATRO ONDANSETR 8MG/4ML PT SYDNA FARMA-JL RC INDONESIA PARENTERAL 1.0X5.0X4 8/29/2019
DP/7178 FARMA PHARMACY (U) N-8 ON VETERAN NO.89- ORDINARY .0 ML
LIMITED HYDROCHLOR BINTARO,JARKATA, 12330, AMPOULES AMPOULE
IDE INDONESIA
3343 NDA/MAL/H MYLAN KIMSY MEDS AVONZA TENOFOVIR 300MG+30 MYLAN LABORATORIES INDIA ORAL SOLID 1.0X1.0X3 11/7/2018
DP/7179 LABORATORIE LTD DISOPROXIL 0MG+400 LIMITEDD ,-PLOT NO.11, ORDINARY 0.0
S LIMITED FUMARATE+L MG 12 & 13, INDORE SPECIAL FILM- TABLET
AMIVUDINE+ ECONOMIC ZONE, COATED CONTAIN
EFAVIRENZ PHARMA ZONE, PHASE-II, TABLETS ER
SECTOR-III, PITHAMPUR-
454775
DIST. DHAR, MADHYA
PRADESH, INDIA.
3344 NDA/MAL/H SQUARE GAMA IVENTI MOXIFLOXACI 0.5%W/V SQUARE BANGLADESH OPHTHALMI 1.0X5.0 8/29/2019
DP/7180 PHARMACEUT PHARMACEUTIC N PHARMACEUTICALS C DROPS ML
ICALS LTD ALS (U) LIMITED HYDROCHLOR LIMITED - DHAKA UNIT- BOTTLE
IDE KALIAKOIR GAZIPUR
3345 NDA/MAL/H SURGE LAB JEET SURGIBION VITAMIN B1 + 100MG, + SURGE LABORATORIES INDIA PARENTERAL 1.0X5.0X5 8/29/2019
DP/7181 (PVT) LIMITED PHARMACEUTIC VITAMIN B6 + 100MG + (PVT) LTD.,,-10TH KM, ORDINARY .0X3.0 ML
ALS LIMITED VITAMIN B12 1000MCG FAISALABAD ROAD, BIKHI, AMPOULES AMPOULE
PAKISTAN.
3346 NDA/MAL/H SUNRISE ROYAL PHARMA SUNFLAM MELOXICAM 7.5G SUNRISE INTERNATIONAL INDIA ORAL SOLID 1.0X10.0X 8/29/2019
INDIA
3347 NDA/MAL/H SUNRISE ROYAL PHARMA LEVOSUN- LEVOFLOXACI 500MG SUNRISE INTERNATIONAL INDIA ORAL SOLID 1.0X10.0X 8/29/2019
DP/7183 INTERNATION 2011 LIMITED 500 N LABS LTD-PLOT NO. 100, ORDINARY 10.0
AL LABS LTD HEMIHYDRAT LANE-5, SECTOR-II, PHASE- TABLETS TABLET
E II, IDA, CHERLAPALLY BLISTER
INDIA
3348 NDA/MAL/H SUNRISE ROYAL PHARMA ZITHROSUN- AZITHROMYCI 500MG SUNRISE INTERNATIONAL INDIA ORAL SOLID 1.0X3.0X1 8/29/2019
DP/7187 INTERNATION 2011 LIMITED 500 N LABS LTD-PLOT NO. 100, ORDINARY 0.0
AL LABS LTD DEHYDRATE LANE-5, SECTOR-II, PHASE- FILM- TABLET
II, IDA, CHERLAPALLY COATED BLISTER
INDIA TABLETS
3349 NDA/MAL/H ACULIFE LIFE PHARMA MERONIR MEROPENEM 1000MG ACULIFE HEALTHCARE INDIA PARENTERAL 1.0X1.0 G 11/29/2017
DP/7189 HEALTHCARE AFRICA LIMITED SODIUM PVT. LTD-VILLAGE ORDINARY VIAL +
SACHANA ,TALUKA - DRY VIALS 1*20ML
VIRAMGAM , AMPOULE
AHMEDABAD 382150 OF WFI
GUJARAT
3350 NDA/MAL/H SUNRISE ROYAL PHARMA TRIPSUN-25 AMITRIPTYLI 25MG SUNRISE INTERNATIONAL INDIA ORAL SOLID 1.0X10.0X 8/29/2019
DP/7190 INTERNATION 2011 LIMITED NE LABS LTD-PLOT NO. 100, ORDINARY 10.0
AL LABS LTD HYDROCHLOR LANE-5, SECTOR-II, PHASE- TABLETS TABLET
IDE II, IDA, CHERLAPALLY BLISTER
INDIA
3351 NDA/MAL/H SUNRISE ROYAL PHARMA LORMAN LORATADINE 10MG SUNRISE INTERNATIONAL INDIA ORAL SOLID 1.0X10.0X 8/29/2019
INDIA
3352 NDA/MAL/H SERUM NORVIK RABIVAX-S PURIFIED NOT LESS SERUM INSTITUTE OF INDIA PARENTERAL 1.0X5.0X1 8/29/2019
DP/7197 INSTITUTE OF ENTERPRISES RABIES THAN 2.5 INDIA PVT LTD .-212/2, ORDINARY .0 DOSE
INDIA PVT LIMITED ANTIGEN I.U / DOSE HADAPSAR, PUNE- VIALS VIAL +
LTD (RABIES 411028, INDIA IML
VIRUS DILUENT
PITMAN- AMPOULE
MOORE
STRAIN 3218)
3353 NDA/MAL/H UNIQUE TATA UGANDA SILBECOR SILVER 1%W/W UNIQUE INDIA TOPICAL 1.0X1.0X5 8/29/2019
DP/7198 PHARMACEUT LIMITED SULFADIAZIN PHARMACEUTICAL LABS EXTERNAL 0.0 G
ICAL E LIMITED. .-215-216, 216- CREAMS TUBE
LABORATORIE 219, 304-308, GIDC
S. (A DIVISION PANOLI 394116-GUJARAT
OF J.B.
CHEMICALS
AND
PHARMACEUT
ICALS LTD)
3354 NDA/MAL/H EVA PHARMA GAMA PREGAVALE PREGABALIN 75MG EVA PHARMA FOR EGYPT ORAL SOLID 1.0X3.0X1 1/2/2019
DP/7199 FOR PHARMACEUTIC X 75 PHARMACEUTICALS AND ORDINARY 0.0
PHARMACEUT ALS (U) LIMITED MEDICAL APPLIANCES-176 CAPSULES CAPSULE
ICALS & EL SADAT ST. KAFR EL BLISTER
APPLIANCES - EGYPT
3355 NDA/MAL/H SERUM NORVIK MEASLES LIVE, NLT 1000 SERUM INSTITUTE OF INDIA PARENTERAL 1.0X50.0X 8/29/2019
DP/7201 INSTITUTE OF ENTERPRISES AND ATTENUATED CCID50 + INDIA PVT LTD .-212/2, ORDINARY 10.0 DOSE
INDIA PVT LIMITED RUBELLA MEASLES 1000 HADAPSAR, PUNE- VIALS VIAL +
LTD VACCINE VIRUS + LIVE CCID50 / 411028, INDIA 5ML
ATTENUATED DOSE DILUENT,1
RUBELLA .0X50.0X1
VIRUS .0 DOSE
VIAL +
1ML
DILUENT
3356 NDA/MAL/H NOVARTIS SURGIPHARM VILDAGLIPT VILDAGLIPTIN 50MG NOVARTIS PHARMA STEIN SWITZERLAN ORAL SOLID 1.0X4.0X1 7/1/2017
DP/7202 PHARMA (U) LIMITED IN AG- D ORDINARY 4.0
SERVICES INC SCHAFFHARVSERTRASSE TABLETS TABLET
CH-4332 STEIN BLISTER
SWITZERLAND. NOVARTIS
FARMACEUTICA SA-
RONDA DE SANTA
MARIA,158, E-08210
BARBERA DEL VALLES
BARCELONA SPAIN
3357 NDA/MAL/H PSA ROYAL PHARMA LOS ANGIO LOSARTAN 50MG ZIM LABORATORIES INDIA ORAL SOLID 1.0X10.0X 8/29/2019
DP/7206 INTERNATION 2011 LIMITED POTASSIUM LIMITED-B-21/22 MIDC ORDINARY 1.0X10.0
AL (EXPORT AREA KALMESHWAR FILM- TABLET
DIVISION OF 441501, DIST NAGPUR, COATED BLISTER
PSA MAHARASHTRA TABLETS
CHEMICALS
AND
PHARMACEUT
ICALS PVT.
LTD)
3358 NDA/MAL/H PSA ROYAL PHARMA TOXXET 50 CEFPODOXIM 50MG ZIM LABORATORIES INDIA ORAL LIQUID 1.0X30.0 8/29/2019
DP/7207 INTERNATION 2011 LIMITED E PROXETIL LIMITED-B-21/22 MIDC ORDINARY ML
AL (EXPORT AREA KALMESHWAR DRY BOTTLE
DIVISION OF 441501, DIST NAGPUR, SUSPENSION
PSA MAHARASHTRA S/SYRUPS/D
CHEMICALS ROPS
AND
PHARMACEUT
ICALS PVT.
LTD)
3359 NDA/MAL/H BROOKES HARLEYS MINOXIN MINOXIDIL 2%W/V BROOKES PHARMA PAKISTAN TOPICAL 1.0X1.0X6 9/26/2018
DP/7209 PHARMA UGANDA SOLUTION (PRIVATE) LIMITED-58-59, EXTERNAL 0.0 ML
(PRIVATE) LIMITED SECTOR NO. 15, KORANGI LIQUIDS BOTTLE
KARACHI-74900
3360 NDA/MAL/H BROOKES HARLEYS ACURON ATRACURIUM 10MG /ML BROOKES PHARMA PAKISTAN PARENTERAL 1.0X5.0X3 8/28/2019
DP/7213 PHARMA UGANDA BESYLATE (PRIVATE) LIMITED-58-59, ORDINARY .0 ML
(PRIVATE) LIMITED SECTOR NO. 15, KORANGI AMPOULES AMPOULE
KARACHI-74900
3361 NDA/MAL/H FRESENIUS SURGIPHARM SMOFKABIV [GLUCOSE [13%] + FRESENIUS KABI AB- AUSTRIA PARENTERAL 1.0X1904. 2/4/2019
DP/7214 KABI SOUTH (U) LIMITED EN MONOHYDRA [8.4G + RAPSGATAN 7, UPPSALA, SWEDEN ORDINARY 0 ML BAG
AFRICA (PTY) PERIPHERA TE] + AMINO 7.2G + SE-751 74 INFUSION :(1*[1036
LIMITED L ACID 6.6G + BAGS ML
EMULSION SOLUTION 1.8G + GLUCOSE
FOR WITH 3.0G + 13% +
INFUSION, ELECTROLYTE 4.4G + 600ML
1904ML - S: [ALANINE 4.0G + AMINO
1300KCAL + ARGININE + 2.6G + ACID
GLYCINE + 3.1G + SOLUTION
HISTIDINE + 6.7G + WITH
ISOLEUCINE + 3.9G + ELECTROL
3362 NDA/MAL/H SHIN POONG ESCORTS PYRAMAX PYRONARIDI 60MG + SHIN POONG PHARM. CO., SOUTH ORAL LIQUID 1.0X90.0 8/29/2019
DP/7216 PHARMACEUT PHARMACEUTIC NE 20MG LTD-70, SANDAN-RO, 19 KOREA ORDINARY SACHET
ICALS CO.LTD ALS LTD - TETRAPHOSP BEON-GIL, DANWON-GU, OTHER CARTON
WILSON ROAD HATE + ANSAN-SI, GYEONGGI-DO, POWDERS/G
ARTESUNATE REPUBLIC OF KOREA RANULES
3363 NDA/MAL/H PINNACLE METRO AARPANTO PANTOPRAZO 40MG PINNACLE LIFE SCIENCE INDIA ORAL SOLID 1.0X3.0X1 7/25/2018
DP/7217 LIFE SCIENCE PHARMACEUTIC 40 LE PVT LTD-KHASRA NO. ORDINARY 0.0
PVT. LTD. ALS LIMITED 1328-1330, VILLAG ENTERIC- TABLET
3364 NDA/MAL/H PINNACLE METRO AARTMIN METFORMIN 500MG PINNACLE LIFE SCIENCE INDIA ORAL SOLID 1.0X10.0X 11/29/2017
3365 NDA/MAL/H THEON AIVEEN (U) THEOXONE - CEFTRIAXONE 1G THEON INDIA PARENTERAL 1.0X1.0 G 11/29/2017
DP/7219 PHARMACEUT LIMITED 1G PHARMACEUTICALS LTD.- ORDINARY VIAL
ICALS LTD VILLAGE SAINI MAJRA, DRY VIALS
TEHSIL NALAGARH DIST,
SOLAN- 174101,
3366 NDA/MAL/H RAINBOW EUROPA NAPRIN NAPROXEN 500MG GLOBELA PHARMA INDIA ORAL SOLID 1.0X3.0X1 8/29/2019
DP/7220 LIFE SCIENCES HEALTHCARE PVT.LTD.-PLOT ORDINARY 0.0
PVT.LTD. (U) LTD NO.357,G.I.D.C SACHIN TABLETS TABLET
ROAD NO.3,SURAT- BLISTER
394230,GUJARAT
3367 NDA/MAL/H MYLAN AIVEEN (U) SAMSUNAT ARTESUNATE 60MG SAMRUDH INDIA PARENTERAL 1.0X5.0 11/27/2019
DP/7222 PHARMACEUT LIMITED E PHARMACEUTICALS PVT ORDINARY ML VIAL
ICAL PRIVATE LTD-J-174, J-168 & J-168/1, VIALS OF
LIMITED, MIDC, TARAPUL, BOISAR, ARTESUN
INDIA DIST THANE-401506 ATE
+(1*1ML
AMPOULE
OF
SODIUM
BICARBO
NATE BP
5%W/V)+(
3368 NDA/MAL/H LAURUS LABS BEYOND DOLUTEGR DOLUTEGRAV 50MG LAURUS LABS LTD (UNIT 2)- INDIA ORAL SOLID 1.0X30.0 11/27/2019
DP/7223 LIMITED - LOGISTICS LTD AVIR IR PLOT NO. 19, 20 & 21 ORDINARY TABLET
WESTERN SECTOR, APSEZ, FILM- BOTTLE,1.
ATCHUTAPURAM, 531011, COATED 0X90.0
VISAKHAPTNAM, ANDRA TABLETS TABLET
PRADESH, BOTTLE
3369 NDA/MAL/H MACLEODS NORVIK LUMITER ARTEMETHER 80MG + OXALIS LAB-VILLAGE INDIA ORAL SOLID 1.0X2.0X6 11/27/2019
DP/7225 PHARMACEUT ENTERPRISES 80/480 + 480MG THEDA, P.O. LODHIMAJRA, ORDINARY .0 TABLET
ICALS LTD LIMITED LUMEFANTRI TEHSIL BADDI, DIST. TABLETS BLISTER
NE SOLAN (HP) PIN CODE
174101
3370 NDA/MAL/H JAMJOOM MU PHARMA CO ELICA-M MOMETASON 0.1%W/W JAMJOOM SAUDI TOPICAL 1.0X30.0 11/27/2019
DP/7226 PHARMACEUT -SMC LIMITED E FUROATE + + 2%W/W PHARMACEUTICALS CO.- ARABIA EXTERNAL G TUBE
ICALS MICONAZOLE PLOT NO. ME 1:3, PHASE CREAMS
COMPANY NITRATE V, INDUSTRIAL CITY, P.O.
BOX 6267 JEEDAH
3371 NDA/MAL/H NATIONAL ANDYCO NEMADOL TRAMADOL 50MG NATIONAL HEALTHCARE NEPAL ORAL SOLID 1.0X10.0X 11/29/2017
DP/7227 HEALTHCARE PHARMACY 50 HYDROCHLOR PVT. LTD.-(WORKS: ORDINARY 10.0
PVT LTD (UGANDA) LTD IDE STERILE BLOCK) CAPSULES CAPSULE
CHHATAPIPRA-3, BARA, BLISTER
NEPAL
3372 NDA/MAL/H SANDOZ SURGIPHARM AMOXICILLI AMOXICILLIN 250 MG SANDOZ GMBH AUSTRIA ORAL SOLID 1.0X10.0X 7/1/2017
DP/7228 GMBH, (U) LIMITED N 250MG TRIHYDRATE BIOCHEMISTRASSE 10- ORDINARY 10.0
KUNDL DISPERSIBL 6250 KUNDL, AUSTRIA SOLUBLE TABLET
E TABLETS TABLETS BLISTER
3373 NDA/MAL/H PINNACLE METRO AARCIFLOX CIPROFLOXAC 500MG PINNACLE LIFE SCIENCE INDIA ORAL SOLID 1.0X10.0X 11/29/2017
DP/7229 LIFE SCIENCE PHARMACEUTIC 500 IN PVT LTD-KHASRA NO. ORDINARY 10.0
3374 NDA/MAL/H NATIONAL ANDYCO LIGNAT 2% LIDOCAINE 2% W/V NATIONAL HEALTHCARE NEPAL PARENTERAL 1.0X30.0 7/1/2017
DP/7231 HEALTHCARE PHARMACY HYDROCHLOR PVT LTD-CHHATAPIPRA 3 ORDINARY ML VIAL
PVT LTD (UGANDA) LTD IDE BARA VIALS
3375 NDA/MAL/H PSA ROYAL PHARMA CIFF-100 DS CEFIXIME 100MG/5 PSA INTERNATIONAL INDIA ORAL LIQUID 1.0X100.0 8/29/2019
DP/7232 INTERNATION 2011 LIMITED ML (EXPORT DIVISION OF PSA ORDINARY ML
AL (EXPORT CHEMICALS & DRY BOTTLE
DIVISION OF PHARMACEUTICALS PVT. SUSPENSION
PSA LTD.) -B-21/22, MIDC S/SYRUPS/D
CHEMICALS AREA, KALMESHWAR-441 ROPS
AND 501, NAGPUR,
PHARMACEUT MAHARASHTRA
ICALS PVT.
LTD)
3376 NDA/MAL/H NATIONAL ANDYCO MIZOVA MIDAZOLAM 1MG/ML NATIONAL HEALTHCARE NEPAL PARENTERAL 1.0X1.0X5 5/30/2018
DP/7233 HEALTHCARE PHARMACY PVT LTD-CHHATAPIPRA 3 ORDINARY .0 ML
PVT LTD (UGANDA) LTD BARA NEPAL VIALS VIAL
3377 NDA/MAL/H ABARIS ROYAL PHARMA LEVOFLOXA LEVOFLOXACI 500MG + ABARIS HEALTHCARE PVT. INDIA PARENTERAL 1.0X100.0 8/28/2019
DP/7234 HEALTHCARE 2011 LIMITED CIN N 5W/V% LTD-SURVEY NO. 1407/11, ORDINARY ML
PVT. LTD INTRAVEN HEMIHYDRAT VILLAGE RAJPUR, TAL KADI INFUSION BOTTLE
OUS E + GLUCOSE DIST. MEHSANA, GUJARAT- VIALS/BOTTL
INFUSION ANHYDROUS 382740 ES
3378 NDA/MAL/H JAMJOOM MU PHARMA CO OPTIDEX-T DEXAMETHAS 0.1W/V + JAMJOOM SAUDI OPHTHALMI 1.0X5.0 11/27/2019
DP/7235 PHARMACEUT -SMC LIMITED ONE + 0.3%W/V PHARMACEUTICALS CO.- ARABIA C ML
ICALS TOBRAMYCIN PLOT NO. ME 1:3, PHASE SUSPENSION BOTTLE
COMPANY V, INDUSTRIAL CITY, P.O. S
BOX 6267 JEEDAH
3379 NDA/MAL/H MYLAN KIMSY MEDS MYDEKLA DACLATASVIR 30 MG MYLAN LABORATORIES INDIA ORAL SOLID 1.0X1.0X2 11/7/2018
DP/7236 LABORATORIE LTD 30. DIHYDROCHL LIMITED-F- 4 & F-12, ORDINARY 8.0
S LIMITED ORIDE MIDC, MALEGAON, FILM- TABLET
SINNAR, NASHIK -422 113 COATED CONTAIN
MAHARASHTRA, INDIA. TABLETS ER
3380 NDA/MAL/H STEDMAN VEERAM CONTUS CHLORPHENA 1MG + STEDMAN INDIA ORAL LIQUID 1.0X15.0 11/27/2019
DP/7237 PHARMACEUT HEALTHCARE PAEDIATRIC MINE 2.5MG PHARMACEUTICALS PVT. ORDINARY ML
ICALS PVT. (U) LIMITED MALEATE + LTD.-C-4, SIDCO DROPS BOTTLE
LTD PHENYLEPHRI PHARMACEUTICALS
NE COMPLEX, ALATHUR,
HYDROCHLOR THIRUPORUR- 603 110,
IDE TAMIL NADU INDIA
3381 NDA/MAL/H MICRO LABS PHILLIPS NEBILONG- NEBIVOLOL 10MG MICRO LABS LTD 92 INDIA ORAL SOLID 1.0X3.0X1 3/28/2018
DP/7238 LIMITED PHARMACEUTIC 10 HYDROCHLOR SIPCOT -92 SIPCOT ORDINARY 0.0
ALS (UGANDA) IDE HOSUR 635 126 TAMIL TABLETS TABLET
LIMITED NADU BLISTER
3382 NDA/MAL/H EXPHAR SA. SURGIPHARM GENTASOL GENTAMICIN 0.3%W/V AHLCON PARENTERAL (I) INDIA OPHTHALMI 1.0X5.0 11/29/2017
DP/7241 (U) LIMITED SULFATE LTD.--SP-918,BHLWADI C DROPS ML
(RAJ) INDIA M.LIC.: RAJ BOTTLE
2002
3383 NDA/MAL/H STEDMAN VEERAM AMINORIC MULTIVITAMI NA STEDMAN INDIA ORAL SOLID 1.0X1.0X1 11/27/2019
DP/7242 PHARMACEUT HEALTHCARE H NS, PHARMACEUTICALS PVT. ORDINARY 5.0
ICALS PVT. (U) LIMITED MINERALS LTD.-C-4, SIDCO CAPSULES CAPSULE
LTD PHARMACEUTICALS BLISTER,1.
COMPLEX, ALATHUR, 0X1.0X2.0
THIRUPORUR- 603 110, CAPSULE
TAMIL NADU INDIA BLISTER
3384 NDA/MAL/H EVA PHARMA GAMA DESLORAT DESLORATIDI 5MG EVA PHARMA FOR EGYPT ORAL SOLID 2.0X10.0 7/1/2017
DP/7246 FOR PHARMACEUTIC NE PHARMACEUTICALS AND ORDINARY TABLET
PHARMACEUT ALS (U) LIMITED MEDICAL APPLIANCES-176 FILM- STRIP
ICALS & EL SADAT ST. KAFR EL COATED
MEDICAL GABAL, PYRAMIDS, GIZA, TABLETS
APPLIANCES EGYPT
3385 NDA/MAL/H STEDMAN VEERAM VITAFIL-Z MULTIVITAMI NA STEDMAN INDIA ORAL LIQUID 1.0X15.0 11/27/2019
DP/7247 PHARMACEUT HEALTHCARE NS, PHARMACEUTICALS PVT. ORDINARY ML
ICALS PVT. (U) LIMITED MINERALS LTD.-C-4, SIDCO DROPS BOTTLE,1.
LTD PHARMACEUTICALS 0X30.0 ML
COMPLEX, ALATHUR, BOTTLE
THIRUPORUR- 603 110,
TAMIL NADU INDIA
3386 NDA/MAL/H EVA PHARMA GAMA ESOMELOD ESOMEPRAZO 20MG EVA PHARMA FOR EGYPT ORAL SOLID 1.0X2.0X1 7/25/2018
DP/7248 FOR PHARMACEUTIC AN 20 LE PHARMACEUTICALS AND ORDINARY 0.0
PHARMACEUT ALS (U) LIMITED MEDICAL APPLIANCES-176 ENTERIC- TABLET
ICALS & EL SADAT ST. KAFR EL COATED BLISTER
APPLIANCES EGYPT
3387 NDA/MAL/H EVA PHARMA GAMA ESOMELOD ESOMEPRAZO 40MG EVA PHARMA FOR EGYPT ORAL SOLID 1.0X2.0X1 7/25/2018
DP/7249 FOR PHARMACEUTIC AN 40 LE PHARMACEUTICALS AND ORDINARY 0.0
PHARMACEUT ALS (U) LIMITED MAGNESIUM MEDICAL APPLIANCES-176 ENTERIC- TABLET
ICALS & EL SADAT ST. KAFR EL COATED BLISTER
APPLIANCES EGYPT
3388 NDA/MAL/H CIPLA CIPLA QUALITY DOLUTEGR DOLUTEGRAV 50MG + CIPLA QUALITY CHEMICAL UGANDA ORAL SOLID 1.0X30.0 11/29/2019
DP/7250 QUALITY CHEMICAL AVIR IR SODIUM 300MG + INDUSTRIES LIMITED ORDINARY TABLET
CHEMICAL INDUSTRIES SODIUM, +LAMIVUDIN 300MG (CIPLAQCIL)-PLOT 1-7, 1ST TABLETS BOTTLE
INDUSTRIES LIMITED LAMIVUDIN E RING ROAD, LUZIRA
LIMITED E AND +TENOFOVIR INDUSTRIAL PARK
TENOFOVIR DISOPROXIL
DISOPROXIL FUMARATE
FUMARATE
3389 NDA/MAL/H SANDOZ SURGIPHARM HYDROXYU HYDROXYCAR 500MG SALUTAS PHARMA GMBH- GERMANY ORAL SOLID 1.0X10.0X 11/27/2019
DP/7251 GMBH, (U) LIMITED REA BAMIDE OTTO-VON-GUERICKE ORDINARY 10.0
KUNDL ALLEE-1, 39179 BARLEBEN CAPSULES CAPSULE
BLISTER
3390 NDA/MAL/H MUNDIPHAR SURGIPHARM ONICIT PALONOSETR 0.075MG/1 PIERRE FABRE FRANCE PARENTERAL 1.0X3.0 11/27/2019
DP/7252 M PTY (U) LIMITED ON .5ML MEDICAMENT ORDINARY ML VIAL
LIMITED PRODUCTION/ AQUITAINE VIALS
PHARM INTERNATIONAL-
AVENUE DU BEARN 64320
IDRON
3391 NDA/MAL/H MANKIND TATA UGANDA MONTICOP MONTELUKAS 10MG + MANKIND PHARMA LTD, INDIA ORAL SOLID 1.0X3.0X1 11/27/2019
DP/7253 PHARM LTD LIMITED E T SODIUM + 5MG UNIT II ,-VILLAGE- ORDINARY 0.0
LEVOCETIRIZI KISHANPURA, PAONTA TABLETS TABLET
NE SAHIB, DIST. SIRMOUR, HP BLISTER
DIHYDROCHL
ORIDE
3392 NDA/MAL/H MICRO LABS LABOREX ESOFAG KIT AMOXICILLIN 1000MG + MICRO LABS LIMITED .,-92, INDIA ORAL SOLID 1.0X7.0X6 11/27/2019
DP/7256 LTD UGANDA + 500MG + SIPCOT, HOSUR 635126 ORDINARY .0 TABLET
LIMITED CLARITHROM 20MG TABLETS STRIP
YCIN + (2+2+2)
ESOMEPRAZO
LE
3393 NDA/MAL/H PINNACLE METRO PAARPIN PARACETAM 650 MG PINNACLE LIFE SCIENCE INDIA ORAL SOLID 1.0X10.0 7/1/2017
DP/7257 LIFE SCIENCE PHARMACEUTIC TABLET OL PVT LTD-KHASRA NO. ORDINARY TABLET
PVT. LTD. ALS LIMITED 1328-1330, VILLAG TABLETS BLISTER
MANPURA, TEHSIL, BADDI,
DIST. SOLAN (HP)
3394 NDA/MAL/H GILEAD MEDICAL DESCOVY EMTRICITABI 200MG/10 PATHEON INC.--TORONTO CANADA ORAL SOLID 1.0X30.0 1/31/2018
DP/7258 SCIENCE INC ACCESS 200MG/10 NE + MG REGIONAL OPERATIONS ORDINARY TABLET
(UGANDA) MG TENOFOVIR 2100, SYNTEX COURT, FILM- BOTTLE
LIMITED ALAFENAMID MISSISSAUGA, ONTARIO, COATED
E CANADA, L5N 7K9 TABLETS
ROTTENDORF PHARMA
GMBH-OSTENFELDER
STRAßE 51-61,59320
ENNIGERLOH,GERMANY
3395 NDA/MAL/H FERRER LABOREX ENEAS ENALAPRIL + 10MG + FERRER INTERNATIONAL SPAIN ORAL SOLID 1.0X3.0X1 11/27/2019
DP/7259 INTERNATION UGANDA 10/20 NIFEDIPINE 20MG S.A ..-JOAN BUSCALLA, 1 - ORDINARY 0.0
AL, S.A. LIMITED 9, 08173 SANT CUGAT DEL TABLETS TABLET
VALLES, BARCELONA BLISTER
3396 NDA/MAL/H MICRO LABS LABOREX ESOFAG-40 ESOMEPRAZO 40MG MICRO LABS LIMITED .,-92, INDIA ORAL SOLID 1.0X3.0X1 11/27/2019
DP/7260 LTD UGANDA LE SIPCOT, HOSUR 635126 ORDINARY 0.0
LIMITED MAGNESIUM TABLETS TABLET
TRIHYDRATE BLISTER
3397 NDA/MAL/H PHARCO WIDE MIOPAN MAGALDRATE 540MG + PHARCO EGYPT ORAL LIQUID 1.0X100.0 7/1/2017
DP/7264 PHARMACEUT SPECTRUM PLUS +SIMETHICON 40MG/5ML PHARMACEUTICALS LTD- ORDINARY ML
ICALS ENTERPRISES SUSPENSIO E KILO 31 ALEXANDRIA, SUSPENSION BOTTLE
(U) LIMITED N CAIRO DESERT ROAD, S
ALEXANDRIA EGYPT
3398 NDA/MAL/H CIPLA LTD. QUALITY ATAZANAVI ATAZANAVIR 300 MG + CIPLA LTD(PATALGANGA)- INDIA ORAL SOLID 1.0X1.0X3 5/30/2018
DP/7266 CHEMICALS LTD - R SULFATE SULFATE + 100 MG CIPLA LIMITED, ORDINARY 0.0
HUMAN AND RITONAVIR PLOT NO. A-42 (UNIT FILM- TABLET
RITONAVIR USP II),MIDC,PATALGANGADIS COATED BOTTLE
TABLETS TRICT - RAIGAD, TABLETS
MAHARASHTRA,INDIA
3399 NDA/MAL/H MICRO LABS LABOREX ESOFAG-20 ESOMEPRAZO 20MG MICRO LABS LIMITED .,-92, INDIA ORAL SOLID 1.0X3.0X1 11/27/2019
DP/7267 LTD UGANDA LE SIPCOT, HOSUR 635126 ORDINARY 0.0
LIMITED MAGNESIUM TABLETS TABLET
TRIHYDRATE BLISTER
3400 NDA/MAL/H EXPHAR SA. SURGIPHARM FEBRILEX PARACETAM 125MG+5 GRACURE INDIA ORAL LIQUID 1.0X150.0 7/1/2017
DP/7269 (U) LIMITED SYRUP OL+DEXTROM MG+1MG/ PHARMACEUTICAL LTD-E- ORDINARY ML
ETORPHAN 5 ML 1105, RIICO IND. AREA, SYRUPS BOTTLE
HYDROBROM PHASE III, BHIWADI,
IDE+CHLORP DISTRICT ALWAR
HENAMINE (RAJASTHAN)
MALEATE
3401 NDA/MAL/H MICRO LABS PHILLIPS TURBOVAS ROSUVASTATI 5MG + MICRO LABS LIMITED .,-92, INDIA ORAL SOLID 1.0X3.0X1 11/27/2019
DP/7271 LTD PHARMACEUTIC CP N CALCIUM + 75MG SIPCOT, HOSUR 635126 ORDINARY 0.0
ALS (UGANDA) CLOPIDOGREL CAPSULES CAPSULE
LIMITED BLISTER
3402 NDA/MAL/H CIPLA CIPLA QUALITY ZENTAIR ENTECAVIR 0.5MG CIPLA QUALITY CHEMICAL UGANDA ORAL SOLID 1.0X10.0 7/1/2017
DP/7274 QUALITY CHEMICAL 0.5MG INDUSTRIES LIMITED-PLOT ORDINARY TABLET
CHEMICAL INDUSTRIES 1-7, LUZIRA FILM- BLISTER
INDUSTRIES LIMITED COATED
LIMITED TABLETS
3403 NDA/MAL/H MICRO LABS PHILLIPS TILYPTIN 20 TENELIGLIPTI 20MG MICRO LABS LIMITED .,-92, INDIA TOPICAL 1.0X3.0X1 11/27/2019
DP/7275 LTD PHARMACEUTIC N SIPCOT, HOSUR 635126 EXTERNAL 0.0
ALS (UGANDA) HYDROBROM TABLETS TABLET
LIMITED IDE HYDRATE BLISTER
3404 NDA/MAL/H İLKO İLAÇ CORE ACCESS ALERINIT LEVOCETIRIZI 5MG İLKO İLAÇ SANAYI VE TURKEY ORAL SOLID 1.0X2.0X2 8/28/2019
DP/7277 SANAYI VE LIMITED NE TICARET A. Ş-3. ORGANIZE ORDINARY 0.0
TICARET A. Ş. HYDROCHLOR SANAYI BÖLGESI KUDDUSI FILM- TABLET
IDE CAD. 23. SOK. NO:1 COATED BLISTER
3405 NDA/MAL/H TIL HARLEYS NEUTROSE DL- 200MG + TIL HEALTHCARE PVT INDIA ORAL SOLID 1.0X3.0X1 11/27/2019
DP/7278 HEALTHCARE UGANDA C METHIONINE 200MG LIMITED-PLOT 100, WEST ORDINARY 0.0
PVT LTD LIMITED + CHOLINE +3MG + R-5, SOUTH, SRICITY SEZ, COATED TABLET
BITARTRATE 3MG + CHERIVE9 (VI), DISTRICT: TABLETS BLISTER
+ THIAMINE 1.5MG + CHITOOR 517588
MONO 22.5MG + ANDHRA PRADESH-
NITRATE + 4.5MG +
RIBOFLAVIN + 0.1MG +
PYRIDOXINE 0.5MG +
HYDROCHLOR 3MCG +
IDE + 7.5.I.U
NICOTINAMI
3406 NDA/MAL/H TIL HARLEYS ASTYMIN- L-THREONINE 4.2MG + TIL HEALTHCARE PVT INDIA ORAL SOLID 1.0X3.0X1 11/27/2019
DP/7283 HEALTHCARE UGANDA M FORTE + L-VALINE + 6.7MG + LIMITED-PLOT 100, WEST ORDINARY 0.0
PVT LTD LIMITED DL- 18.4MG + R-5, SOUTH, SRICITY SEZ, CAPSULES CAPSULE
METHIONINE 5.9MG + CHERIVE9 (VI), DISTRICT: BLISTER
+ L- 18.3MG + CHITOOR 517588
ISOLEUCINE + 5.0MG + ANDHRA PRADESH-
L-LEUCINE + L- 5.0MG +
PHENYLALANI 25MG +
NE + L- 5MG +
TRYPTOPHAN 3MG +
+ L-LYSINE 1.5MG +
HYDROCHLOR 25MG +
3407 NDA/MAL/H İLKO İLAÇ CORE ACCESS LIVERCOL ROSUVASTATI 10MG İLKO İLAÇ SANAYI VE TURKEY ORAL SOLID 1.0X2.0X1 7/25/2018
DP/7284 SANAYI VE LTD 10 N CALCIUM TICARET A. Ş.-3. 42050 ORDINARY 4.0
TICARET A. Ş. SELÇUKLU / KONYA FILM- TABLET
TURKEY COATED BLISTER
TABLETS
3408 NDA/MAL/H EGYPTIAN WIDE TOBRIN TOBRAMYCIN 3MG/G EGYPTIAN EGYPT OPHTHALMI 1.0X5.0 G 7/1/2017
DP/7286 INTERNATION SPECTRUM OPHTHALM INTERNATIONAL C TUBE
AL ENTERPRISES IC PHARMACEUTICAL OINTMENTS
PHARMACEUT (U) LIMITED OINTMENT INDUSTRIES CO. A.R.E-
COMPANY EGYPT
3409 NDA/MAL/H EGYPTIAN WIDE EPISTIGMIN NEOSTIGMIN 0.05%W/V EGYPTIAN EGYPT PARENTERAL 1.0X5.0X1 7/1/2017
DP/7287 INTERNATION SPECTRUM 0.05% E INTERNATIONAL ORDINARY .0 ML
AL ENTERPRISES METHYLSULP PHARMACEUTICAL AMPOULES AMPOULE
PHARMACEUT (U) LIMITED HATE INDUSTRIES CO. A.R.E-
COMPANY B1,EGYPT
3410 NDA/MAL/H MENARINI PHILLIPS KETESSE DEXKETOPRO 25MG A.MENARINI ITALY ORAL SOLID 1.0X2.0X1 1/31/2017
DP/7288 INTERNATION PHARMACEUTIC FILM FEN MANUFACTURING ORDINARY 0.0
AL ALS (UGANDA) COATED TROMETAMO LOGISTICS AND SERVICES FILM- TABLET
OPERATIONS LIMITED TABLETS L S.R.I-VIA CAMPO DI PILE COATED BLISTER
LUXEMBOUR 67100 L'AQUILA TABLETS
G S.A.
3411 NDA/MAL/H TIL HARLEYS PEGLEC POLYETHYLE 118.0G TIL HEALTHCARE PVT INDIA ORAL LIQUID 1.0X1.0X1 11/27/2019
DP/7289 HEALTHCARE UGANDA NE GLYCOL + +2.93G LIMITED-PLOT 100, WEST ORDINARY 37.15 G
PVT LTD LIMITED SODIUM +1.484G + R-5, SOUTH, SRICITY SEZ, SOLUBLE SACHET
CHLORIDE + 3.370G + CHERIVE9 (VI), DISTRICT: POWDERS
POTASSIUM 11.360G / CHITOOR 517588
CHLORIDE + SACHET ANDHRA PRADESH-
SODIUM
BICARBONAT
E+
ANHYDROUS
SODIUM
SULFATE
3412 NDA/MAL/H LEBEN ANDYCO IBUPLUS IBUPROFEN+. 100MG + LEBEN LABORATORIES PVT INDIA ORAL LIQUID 1.0X1.0X1 11/27/2019
DP/7292 LABORATORIE PHARMACY SUSPENSIO PARACETAM 125MG / LTD .-L-14 PHASE III MIDC ORDINARY 00.0 ML
S PVT LTD (UGANDA) LTD N OL 5ML AKOLA 444 104 SUSPENSION BOTTLE
S
3413 NDA/MAL/H İLKO İLAÇ CORE ACCESS ALRINAST DESLORATADI 5MG İLKO İLAÇ SANAYI VE TURKEY ORAL SOLID 1.0X2.0X1 11/29/2017
DP/7293 SANAYI VE LTD NE TICARET A. Ş-3. ORGANIZE ORDINARY 0.0
TICARET A. Ş. SANAYI BÖLGESI KUDDUSI FILM- TABLET
CAD. 23. SOK. NO:1 COATED BLISTER
3414 NDA/MAL/H EMCURE HARLEYS VONADAY EFAVIRENZ + 600MG + EMCURE INDIA ORAL SOLID 1.0X30.0 11/27/2019
DP/7294 PHARMACEUT UGANDA LAMIVUDINE 300MG + PHARMACEUTICALS ORDINARY TABLET
ICALS LTD LIMITED + TENOFOVIR 300MG LIMITED-PLOT NO. P-2. TABLETS BOTTLE
DISOPROXIL ITBT PARK, PHASE II,
FUMARATE MIDC, HINJWADI PUNE
411057, MHARASHTRA
STATE INDIA
3415 NDA/MAL/H JAMJOOM MU PHARMA CO LAMIFEN TERBINAFINE 1%W/W JAMJOOM SAUDI TOPICAL 1.0X15.0 11/27/2019
DP/7295 PHARMACEUT -SMC LIMITED HYDROCHLOR PHARMACEUTICALS CO.- ARABIA EXTERNAL G TUBE
ICALS IDE PLOT NO. ME 1:3, PHASE CREAMS
BOX 6267 JEEDAH
3416 NDA/MAL/H MICRO LABS PHILLIPS NEBILONG- NEBIVOLOL 2.5 MG MICRO LABS LTD 92 INDIA ORAL SOLID 1.0X3.0X1 11/29/2017
DP/7298 LIMITED PHARMACEUTIC 2.5 HYDROCHLOR SIPCOT -92 SIPCOT ORDINARY 0.0
ALS (UGANDA) IDE HOSUR 635 126 TAMIL TABLETS TABLET
LIMITED NADU BLISTER
3417 NDA/MAL/H SQUARE GAMA CLOTINEX ENOXAPARIN 60MG/PRE- SQUARE BANGLADESH PARENTERAL 1.0X1.0 9/26/2018
DP/7299 PHARMACEUT PHARMACEUTIC 60 SODIUM FILLED PHARMACEUTICALS ORDINARY PREFILLED
ICALS LTD ALS (U) LIMITED SYRINGE LIMITED--DHAKA UNIT PRE-FILLED SYRINGE
KALIAKOIR GAZIPUR – SYRINGES CARTON
1750, BANGLADESH
3418 NDA/MAL/H HETERO LABS AIVEEN (U) PACLITERO PACLITAXEL 60 MG/ML HETERO LABS LIMITED INDIA PARENTERAL 1.0X1.0X5 9/26/2018
DP/7301 LTD LIMITED 300 UNIT-VI -APIIC ORDINARY 0.0 ML
FORMULATION SEZ, VIALS VIAL
POLEPALLY VILLAGE,
JADCHERLA MANDAL,
MAHABOOB NAGAR
(DISTRICT) ANDHRA
PRADESH-509301, , INDIA
3419 NDA/MAL/H JAMJOOM MU PHARMA CO ACRETIN TRETINOIN 0.025%W/ JAMJOOM SAUDI TOPICAL 1.0X30.0 11/27/2019
DP/7302 PHARMACEUT -SMC LIMITED 0.025% W PHARMACEUTICALS CO.- ARABIA EXTERNAL G TUBE
ICALS PLOT NO. ME 1:3, PHASE CREAMS
BOX 6267 JEEDAH
3420 NDA/MAL/H AXA VITACARE AXATOL-20 MANNITOL 20%W/V AXA PARENTERALS LTD- INDIA PARENTERAL 1.0X100.0 2/6/2019
DP/7303 PARENTERALS LIMITED PLOT NO. 936, 937 & 939, ORDINARY ML
UTTARAKHAND
3421 NDA/MAL/H PSA ROYAL PHARMA GABAZURE GABAPENTIN 300 MG ZIM LABORATORIES INDIA ORAL SOLID 1.0X2.0X1 9/26/2018
DP/7304 INTERNATION 2011 LIMITED LIMITED-B-21/22 MIDC ORDINARY 0.0
AL (EXPORT AREA KALMESHWAR CAPSULES CAPSULE
DIVISION OF 441501, DIST NAGPUR, BLISTER,1.
PSA MAHARASHTRA 0X3.0X10.
CHEMICALS 0
AND CAPSULE
PHARMACEUT BLISTER
ICALS PVT.
LTD)
3422 NDA/MAL/H HETERO LABS AIVEEN (U) PACLITERO PACLITAXEL 100 HETERO LABS LIMITED INDIA PARENTERAL 1.0X1.0X1 9/26/2018
DP/7306 LTD LIMITED 100 MG/16.7 UNIT-VI -APIIC ORDINARY 6.7 ML
ML FORMULATION SEZ, VIALS VIAL
POLEPALLY VILLAGE,
JADCHERLA MANDAL,
MAHABOOB NAGAR
(DISTRICT) ANDHRA
PRADESH-509301, , INDIA
3423 NDA/MAL/H STALLION SHREEJI APSIDASE ACECLOFENA 100MG + ACME FORMULATION PVT. INDIA ORAL SOLID 1.0X10.0X 8/28/2019
DP/7308 LABORATORIE PHARMACEUTIC C+ 500MG + LTD-ROPAR ROAD, ORDINARY 10.0
S PVT LTD ALS LIMITED PARACETAM 10MG NALAGARH, DIST. SOLAN, TABLETS TABLET
OL + HIMACHAL PRADESH BLISTER
SERRATIOPEP 174101
TIDASE
3424 NDA/MAL/H JAMJOOM MU PHARMA CO ACRETIN TRETINOIN 0.05%W/W JAMJOOM SAUDI TOPICAL 1.0X30.0 11/27/2019
DP/7310 PHARMACEUT -SMC LIMITED 0.05% PHARMACEUTICALS CO.- ARABIA EXTERNAL G TUBE
ICALS PLOT NO. ME 1:3, PHASE CREAMS
BOX 6267 JEEDAH
3425 NDA/MAL/H JAMJOOM MU PHARMA CO FLUCA FLUOROMET 1%W/V + JAMJOOM SAUDI OPHTHALMI 1.0X5.0 11/27/2019
DP/7311 PHARMACEUT -SMC LIMITED OPTHALMI HOLON + 2%W/V PHARMACEUTICALS CO.- ARABIA C ML
ICALS C SODIUM PLOT NO. ME 1:3, PHASE SUSPENSION BOTTLE
COMPANY SUSPENSIO CROMOGLICA V, INDUSTRIAL CITY, P.O. S
N TE BOX 6267 JEEDAH
3426 NDA/MAL/H PANACEA STAR EASYFIVE- DIPHTHERIA 30 IU + 60 PANACEA BIOTEC LTD-- INDIA PARENTERAL 1.0X0.5 7/1/2017
DP/7313 BIOTEC LTD PHARMACEUTIC TT (FULLY TOXOID + IU + 4 IU + MALPUR, BADDI, TEHSIL, ORDINARY I ML PRE-
ALS LTD LIQUID TETANUS 10MCG + NALAGARH, DIST. SOLAN M PRE- FILLED
PENTAVALE TOXOID + 10 MCG HIMACHAL PRADESH – FILLED SYRINGE
NT INACTIVATED 173 205 SYRINGES
VACCINE) W-B,
PERTUSSIS +
HBSAG + HIB
(PRP-TT)
3427 NDA/MAL/H AUROBINDO PHILLIPS AROXICAM MELOXICAM 7.5MG AUROBINDO PHARMA INDIA ORAL SOLID 1.0X3.0X1 11/27/2019
DP/7315 PHARMA PHARMACEUTIC 7.5 LTD, UNIT III -SURVEY NO. ORDINARY 0.0
LIMITED ALS (UGANDA) 313, 314 BACHUPALLY TABLETS TABLET
LIMITED (VILLAGE) BLISTER
QUTHUBULLAPUR
HYDERABAD ANDHRA
PRADESH 500090
3428 NDA/MAL/H CACHET ASTRA PHARMA I-UP FERROUS 100MG + CACHET INDIA ORAL SOLID 1.0X3.0X1 11/27/2019
DP/7316 PHARMACEUT (U) LIMITED TABLETS ASCORBATE + 1.5MG PHARMACEUTICAL PVT ORDINARY 0.0
ICALS PVT FOLIC ACID LTD. -VILLAGE-THANA, FILM- TABLET
LIMITED NEAR BADDI, COATED BLISTER
TEHSIL_NALAGARH, DIST. TABLETS
SOLAN, HIMACHAL
PRADESH - 173205
3429 NDA/MAL/H CACHET ASTRA PHARMA EMITINO ONDANSETR 8MG CACHET INDIA ORAL SOLID 1.0X1.0X1 11/27/2019
DP/7317 PHARMACEUT (U) LIMITED TABLETS ON PHARMACEUTICAL PVT ORDINARY 0.0
ICALS PVT 8MG LTD. -VILLAGE-THANA, TABLETS TABLET
LIMITED NEAR BADDI, BLISTER
TEHSIL_NALAGARH, DIST.
SOLAN, HIMACHAL
PRADESH - 173205
3430 NDA/MAL/H MYLAN KIMSY MEDS CARDISAR VALSARTAN + 160 MG + AIZANT DRUG RESEARCH INDIA ORAL SOLID 1.0X3.0X1 8/28/2019
DP/7320 PHARMACEUT LTD HT HYDROCHLOR 25 MG SOLUTIONS PVT LTD-SY. ORDINARY 0.0
MANDAL, RR DIST.,
HYDERABAD- 500 100,
TELANGANA
3431 NDA/MAL/H GLENMARK ABACUS ASCORIL DEXTROMET 10MG + GLENMARK INDIA ORAL LIQUID 1.0X1.0X1 11/27/2019
DP/7321 PHARMACEUT PHARMA DRY HORPHAN 1.25MG + PHARMACEUTICALS LTD .- ORDINARY 00.0 ML
ICALS LTD (AFRICA) COUGH HYDROBROM 30MG + PLOT E-37, 39, D ROAD, SYRUPS BOTTLE
LIMITED AND COLD IDE + 1.5MG / MIDC, SATPUR, NASHIK
SYRUP TRIPROLIDINE 5ML 422007, MAHARASHTRA
HYDROCHLOR STATE
IDE +
PSEUDOEPHE
DRINE
HYDROCHLOR
IDE +
MENTHOL
3432 NDA/MAL/H MYLAN KIMSY MEDS CARDISAR VALSARTAN + 160MG + AIZANT DRUG RESEARCH INDIA ORAL SOLID 1.0X3.0X1 8/28/2019
DP/7322 PHARMACEUT LTD HT HYDROCHLOR 12.5MG SOLUTIONS PVT LTD-SY. ORDINARY 0.0
MANDAL, RR DIST.,
HYDERABAD- 500 100,
TELANGANA
3433 NDA/MAL/H BOEHRINGER SURGIPHARM TRAJENTA LINAGLIPTIN 5MG WESTWARD COLUMBUS UNITED ORAL SOLID 1.0X3.0X1 11/27/2019
DP/7327 INGELHEIM (U) LIMITED INC.-1809 WILSON ROAD, STATES ORDINARY 0.0
INTERNATION COLUMBUS OHIO 43228 TABLETS TABLET
AL GMBH BLISTER
3434 NDA/MAL/H DAWA SUPER MEDIC ACEPAR- PARACETAM 500 DAWA LTD -PLOT KENYA ORAL SOLID 1.0X1.0X1 3/28/2018
DP/7329 LIMITED LTD MR OL MG+100 NO.7879/8 BABA ROAD ORDINARY 0.0
+ACECLOFEN MG +375 RUARAKA NAIROBI FILM- TABLET
AC+CHLORZO MG COATED BLISTER
XAZONE TABLETS
3435 NDA/MAL/H MYLAN NORVIK FAMY-POP LEVONORGES 0.03MG MYLAN LABORATORIES INDIA ORAL SOLID 1.0X3.0X3 11/27/2019
DP/7330 LABORATORIE ENTERPRISES TREL LIMITED-PLOT NO. 20 & ORDINARY 5.0
S LIMITED LIMITED 21, PHARMEZ, SARKHEJ - TABLETS TABLET
BAVLA, NATIONAL BLISTER
HIGHWAY NO. 8 - A, NEAR
VILLAGE - MATODA, TAL -
SANAND, DIST.,
AHMEDABAD - 382213
3436 NDA/MAL/H TORRENT KARURI TORIDIP 20 LERCANIDIPI 20MG TORRENT INDIA ORAL SOLID 1.0X1.0X1 11/28/2019
DP/7333 PHARMACEUT PHARMACEUTIC NE PHARMACEUTICALS LTD. - ORDINARY 0.0
ICALS LTD ALS LTD. HYDROCHLOR AHMEDABAD-MEHSANA TABLETS TABLET
IDE HIGHWAY, TAL. KADI, BLISTER,1.
DIST. MEHSANA, INDRAD 0X3.0X10.
382 721, GUJARAT 0 TABLET
BLISTER,1.
0X10.0X10
.0 TABLET
BLISTER
3437 NDA/MAL/H IPCA MEDVIN ETOVA 400 ETODOLAC 400MG IPCA INDIA ORAL SOLID 1.0X3.0X1 7/1/2017
DP/7334 LABORATORIE PHARMA LABORATORIESLIMITED- ORDINARY 0.0
S LTD LIMITED IPCA LABORATORIES LTD TABLETS TABLET
P.O SEJANTA DISTRICT BLISTER
RATLAM 457002 INDIA
DP/7337 CILAG ACCESS 150 STATE ROAD 933 KM 0.1 STATES ORDINARY TABLET
INTERNATION (UGANDA) MARNEY WARD GURABO FILM- BOTTLE
AL NV LIMITED PUERTO RICO 00778 COATED
TABLETS
3439 NDA/MAL/H LEBEN ANDYCO IBUPLUS IBUPROFEN + 400MG + LEBEN LABORATORIES INDIA ORAL SOLID 1.0X15.0X 12/5/2019
DP/7338 LABORATORIE PHARMACY PARACETAM 325MG PVT. LTD-PLOT NO. L-4, ORDINARY 2.0X20.0
S PVT.LTD (UGANDA) LTD OL PHASE-III, MIDC, TABLETS TABLET
AKOLA– 444 104 (MS). BLISTER
3440 NDA/MAL/H AJANTA ABACUS ADERAN 16 CANDESARTA 16 MG AJANTA PHARMA LIMITED- INDIA ORAL SOLID 1.0X3.0X1 5/30/2018
DP/7339 PHARMA PHARMA N CILEXETIL B-4-5-6, MIDC AREA ORDINARY 0.0
LIMITED (AFRICA) PAITHAN, AURANGABAD, TABLETS TABLET
LIMITED 431148 BLISTER
DIST:AURANGABAD
MAHARASHTRA, INDIA.
3441 NDA/MAL/H CADILA ESCORTS ZEALARGY RUPATADINE 10 MG CADILA INDIA ORAL SOLID 1.0X3.0X1 7/1/2017
DP/7342 PHARMACEUT PHARMACEUTIC FUMERATE PHARMACEUTICALS ORDINARY 0.0
STATE, INDIA
3442 NDA/MAL/H WUHAN KAIYUANTANG GLEVIX LEVOFLOXACI 0.5G + WUHAN FUXING CHINA PARENTERAL 1.0X100.0 11/28/2019
DP/7343 FUXING (U) LIMITED N + SODIUM 0.9G BIOPHARMACEUTICAL ORDINARY ML
BIOLOGICAL CHLORIDE CO., LTD-NO.9, FUXING INFUSION BOTTLE
PHARMACEUT ROAD, HANCUAN VIALS/BOTTL
ICAL CO ECONOMIC & ES
DEVELOPMENT DISTRICT,
HUBEI PROVINCE
3443 NDA/MAL/H ACULIFE LIFE PHARMA HEPANIR HEPARIN 1000IU/ML ACULIFE HEALTH CARE, INDIA PARENTERAL 1.0X5.0 11/29/2017
DP/7344 HEALTHCARE AFRICA LIMITED SODIUM FORMALLY ORDINARY ML VIAL
NIRMA(HEALTHCARE VIALS
DIVISION)-VILLAGE:
SACHANA, TALUKA:
VIRAMGAM DISTRICT:
AHMEDABAD-382150
GUJARAT, INDIA
3444 NDA/MAL/H RENE RENE REZN ZINC SULFATE 20MG RENE INDUSTRIES LIMITED- UGANDA ORAL SOLID 1.0X10.0X 11/29/2017
DP/7346 INDUSTRIES INDUSTRIES TABLETS MONOHYDRA PLOT 680 KAMULI- KIREKA ORDINARY 10.0
LTD LIMITED TE SOLUBLE TABLET
TABLETS BLISTER
3445 NDA/MAL/H TWENTY SWASTIK TRYFIX CV CEFIXIME+CL 50MG+31. TWENTY FIRST CENTURY INDIA ORAL LIQUID 1.0X100.0 7/1/2017
DP/7351 FIRST PHARMACEUTIC DS AVULANIC 25MG PHARMACEUTICALS PVT ORDINARY ML
CENTURY AL LTD ACID LTD--ROORKEE DISTT DRY BOTTLE
PHARMACEUT HARIDWAR SUSPENSION
ICALS PVT.LTD S/SYRUPS/D
ROPS
3446 NDA/MAL/H LINCOLN METRO DOLOMOL PARACETAM 100 LINCOLN INDIA ORAL LIQUID 1.0X15.0 2019-11-07
DP/7352 PARENTERAL PHARMACEUTIC PAEDIATRIC OL MG/ML PHARMACEUTICALS LTD-- ORDINARY ML
LIMITED ALS LIMITED DROPS 11 TRIMUL ESTATE, NEAR SUSPENSION BOTTLE
KHATRAJ CHOKADI, P.O. S
KHATRAJ-382721 TA:
KALOL, DIST.
3447 NDA/MAL/H MERCK (PTY) UNITED GLUCOPHA METFORMIN 500MG MERCK KGAA-PHARMA GERMANY ORAL SOLID 1.0X6.0X1 3/28/2018
DP/7353 LTD HEALTHCARE GE XR HYDROCHLOR PRODUCTION RETARD 5.0
DISTRIBUTORS 500MG IDE DARMSTADT - TABLETS TABLET
LTD FRANKFURTER STRABE BLISTER
250, D-64293,
DARMSTADT MERCK
SANTÉ S.A.S.-2 RUE DU
PRESSOIR VERT
45400 SEMOY
FRANCE
3448 NDA/MAL/H WUHAN KAIYUANTANG OSMOTICA SODIUM 0.9%W/V WUHAN FUXING CHINA PARENTERAL 1.0X100.0 11/28/2019
DP/7354 FUXING (U) LIMITED RE CHLORIDE BIOPHARMACEUTICAL ORDINARY ML
BIOLOGICAL CO., LTD-NO.9, FUXING INFUSION BOTTLE,1.
PHARMACEUT ROAD, HANCUAN VIALS/BOTTL 0X250.0
ICAL CO ECONOMIC & ES ML
DEVELOPMENT DISTRICT, BOTTLE,1.
HUBEI PROVINCE 0X500.0
ML
BOTTLE
3449 NDA/MAL/H AJANTA ABACUS ARTEFAN ARTEMETHER 180MG+10 AJANTA PHARMA INDIA ORAL LIQUID 1.0X60.0 1/31/2018
DP/7355 PHARMA PHARMA SUSPENSIO +LUMEFANTR 80MG LIMITED.-B-41516, MIDC ORDINARY ML
LIMITED (AFRICA) N INE INDUSTRIAL AREA, DRY BOTTLE
LIMITED PAITHAN, AURANGABAD- SUSPENSION
431 148 DIST: S/SYRUPS/D
AURANGABAD ROPS
MAHARASHTRA,INDIA
3450 NDA/MAL/H HOVID BHD UNITED DIABETMIN METFORMIN 500MG HOVID BERHAD-121, MALAYSIA ORAL SOLID 1.0X10.0X 7/1/2017
DP/7356 HEALTHCARE TABLET HYDROCHLOR JALAN TUNKU ABDUL ORDINARY 10.0
DISTRIBUTORS 500MG IDE RAHMAN, 30010 IPOH, FILM- TABLET
LTD PERAK, MALAYSIA COATED BLISTER,1.
TABLETS 0X5.0X20.
0 TABLET
BLISTER
3451 NDA/MAL/H CACHET ASTRA PHARMA PAMAGIN-C CETIRIZINE 2.5MG+7.5 CACHET INDIA ORAL LIQUID 1.0X60.0 1/31/2018
DP/7357 PHARMACEUT (U) LIMITED SYRUP HYDROCHLOR MG+125M PHARMACEUTICALS PVT ORDINARY ML
ICALS PVT LTD IDE+DEXTRO G+5MG+7. LTD -THANA BADDI SYRUPS BOTTLE
METHORPHA 5MG+2.5M 173205 DISTRICT SOLAN
N G/5ML (HIMACHAL PRADESH)
HYDROBROM INDIA
IDE+ACETAMI
NOPHEN+PHE
NYLEPHRINE
HYDROCHLOR
IDE+ZINC
GLUCONATE+
3452 NDA/MAL/H INDCHEMIE AARON INDCLAV AMOXICILLIN 500MG+12 INDCHEMIE HEALTH INDIA ORAL SOLID 1.0X2.0X1 7/1/2017
DP/7359 HEALTH PHARMACEUTIC 625 +CLAVULANA 5MG SPECIALITIES PVT LTD- ORDINARY 0.0
SPECIALITIES ALS LIMITED TE VILLAGE THANA TEHSIL FILM- TABLET
PVT. LTD. POTASSIUM BADDI DIST SOLAN COATED BLISTER,1.
HIMACHAL PRADESH 173 TABLETS 0X2.0X7.0
205 TABLET
BLISTER
3453 NDA/MAL/H RECKITT GITTOES GAVISCON SODIUM 500MG + RECKITT BENCKISER UNITED ORAL LIQUID 1.0X150.0 11/28/2019
DP/7360 BENCKISER PHARMACEUTIC DOUBLE ALGINATE + 213MG + HEALTHCARE LTD, HULL- KINGDOM ORDINARY ML
HEALTHCARE ALS LIMITED ACTION SODIUM 325MG/10 DAMSON LANE,HULL, HUB SUSPENSION BOTTLE,1.
(UK) LIMITED LIQUID BICARBONAT ML HU8 7DS S 0X300.0
E + CALCIUM ML
CARBONATE BOTTLE,1.
0X12.0X10
.0 ML
SACHET
3454 NDA/MAL/H MYLAN KIMSY MEDS DOLUTEGR DOLUTEGRAV 50MG MYLAN LABORATORIES INDIA ORAL SOLID 1.0X3.0X1 11/28/2019
DP/7361 PHARMACEUT LTD AVIR IR SODIUM LTD-PLOT NO.11, 12 & 13, ORDINARY 0.0
ICAL PRIVATE INDORE SPECIAL TABLETS TABLET
LIMITED, ECONOMIC ZONE, BLISTER,1.
INDIA PHARMA ZONE, PHASE II, 0X30.0
SECTOR III, PITHAMPUR - TABLET
454775; DIST; DHAR; BOTTLE
MADHYA PRADESH;
3455 NDA/MAL/H INDCHEMIE AARON INDCLAV AMOXICILLIN 200MG+28 INDCHEMIE HEALTH INDIA ORAL LIQUID 1.0X100.0 7/1/2017
DP/7363 HEALTH PHARMACEUTIC 228 +CLAVULANA MG/5ML SPECIALITIES PVT. LTD.- ORDINARY ML
SPECIALITIES ALS LIMITED TE VILLAGE & P.O – THANA, DRY BOTTLE
PVT. LTD. POTASSIUM TEHSIL – BADDI, SUSPENSION
DIST- SOLAN, HIMACHAL S/SYRUPS/D
ROPS
3456 NDA/MAL/H İLKO İLAÇ CORE ACCESS MOKSEFEN MOXIFLOXACI 400MG İLKO İLAÇ SANAYI VE TURKEY ORAL SOLID 1.0X7.0 7/1/2017
DP/7364 SANAYI VE LIMITED 400 MG N TICARET A. Ş-3. ORGANIZE ORDINARY TABLET
TICARET A. Ş. HYDROCHLOR SANAYI BÖLGESI KUDDUSI FILM- BLISTER
IDE CAD. 23. SOK. NO:1 COATED
3457 NDA/MAL/H AUROCHEM SUPER MEDIC DOLOACT PARACETAM 500 KARALEX PHARMA-58, INDIA ORAL SOLID 1.0X3.0X1 7/1/2017
DP/7365 PHAMACEAU LTD MR OL+ MG+50 PALGHAR TALUKA, ORDINARY 0.0
TICALS (1) DICLOFENAC MG+250 INDUSTRIAL CO.-OP. TABLETS TABLET
LTD) POTASSIUM+ MG ESTATE LTD.PALGHAR BLISTER
CHLORZOXAZ –INDIA
ONE
3458 NDA/MAL/H TWENTY SWASTIK TRYFIX CEFIXIME 200MG TWENTY FIRST CENTURY INDIA ORAL SOLID 1.0X10.0 7/1/2017
DP/7366 FIRST PHARMACEUTIC PHARMACEUTICALS PVT ORDINARY TABLET
CENTURY AL LTD LTD--ROORKEE DISTT FILM- STRIP
PHARMACEUT HARIDWAR COATED
ICALS PVT.LTD TABLETS
3459 NDA/MAL/H TWENTY SWASTIK TRYFIX 100 CEFIXIME 100MG/5 TWENTY FIRST CENTURY INDIA ORAL LIQUID 1.0X100.0 7/1/2017
DP/7367 FIRST PHARMACEUTIC DS ML PHARMACEUTICALS PVT ORDINARY ML
CENTURY AL LTD LTD--ROORKEE DISTT DRY BOTTLE
ROPS
3460 NDA/MAL/H OCTOBER ABACUS BRADIPECT IVABRADINE 7.5MG OCTOBER PHARMA-1ST EGYPT ORAL SOLID 1.0X4.0X7 11/28/2019
DP/7368 PHARMA PHARMA HYDROCHLOR INDUSTRIAL ZONE, STREET ORDINARY .0 TABLET
(AFRICA) IDE 25 PLOT 190, 6TH TABLETS BLISTER
LIMITED OCTOBER CITY CAIRO,
ARAB REPUBLIC OF EGYPT
3461 NDA/MAL/H TWENTY SWASTIK XOMOX CV AMOXICILLIN 200MG+28 TWENTY FIRST CENTURY INDIA ORAL LIQUID 1.0X100.0 7/1/2017
DP/7369 FIRST PHARMACEUTIC DS TRIHYDRATE+ .5MG/5ML PHARMACEUTICALS ORDINARY ML
CENTURY AL LTD POTASSIUM PVT.LTD-UNIT II, KHASRA DRY BOTTLE
PHARMACEUT CLAVULANAT NO: 282, NALHERI SUSPENSION
ICALS PVT.LTD E DEHVIRAN, S/SYRUPS/D
NALHERA ROPS
ANANTPUR,PUHANA -
IQBALPUR ROAD,
ROORKEE
3462 NDA/MAL/H TWENTY SWASTIK XOMOX CV AMOXICILLIN 500MG+12 TWENTY FIRST CENTURY INDIA ORAL SOLID 1.0X2.0X1 7/1/2017
DP/7370 FIRST PHARMACEUTIC 625 TRIHYDRATE+ 5MG PHARMACEUTICALS ORDINARY 0.0
CENTURY AL LTD POTASSIUM PVT.LTD-UNIT II, KHASRA FILM- TABLET
PHARMACEUT CLAVULANAT NO: 282, NALHERI COATED STRIP
ICALS PVT.LTD E DEHVIRAN, TABLETS
NALHERA
ANANTPUR,PUHANA -
IQBALPUR ROAD,
ROORKEE
3463 NDA/MAL/H ALKEM ABACUS OLKEM 40 OLMESARTAN 40MG ALKEM LABS LTD.-VILLAGE INDIA ORAL SOLID 1.0X3.0X1 11/28/2019
DP/7371 LABORATORIE PHARMA MEDOXOMIL THANA, BADDI, THE ORDINARY 0.0
S LIMITED (AFRICA) NALAGARH, DIST SOLAN FILM- TABLET
LIMITED (HP) 173205 COATED BLISTER
TABLETS
3464 NDA/MAL/H OCHOA SUPER MEDIC FUSIGO FUSIDIC ACID 2.0 % W/W AUROCHEM INDIA TOPICAL 1.0X10.0 7/1/2017
DP/7373 LABORATORIE LTD CREAM LABORATORIES (I) PVT LTD- EXTERNAL G TUBE
S -8 PALGHAR TALUKA CREAMS
INDUSTRIAL CO-OP
ESTATE LTD PALGHAR 401
404 DIST THANE
3465 NDA/MAL/H OCHOA SUPER MEDIC FUSIGO-HC FUSIDIC ACID 2.0 % AUROCHEM INDIA TOPICAL 1.0X15.0 11/29/2017
DP/7374 LABORATORIE LTD CREAM +HYDROCORT W/W+1.0 LABORATORIES (I) PVT LTD- EXTERNAL G TUBE
S ISONE % W/W -8 PALGHAR TALUKA CREAMS
ACETATE INDUSTRIAL CO-OP
404 DIST THANE
3466 NDA/MAL/H INTAS AIVEEN (U) FOLISURGE FOLLITROPIN 75IU/0.12 INTAS PHARMACEUTICALS INDIA PARENTERAL 1.0X0.12 11/28/2019
DP/7375 PHARMACEUT LIMITED 75 ALFA ML LTD (BIOPHARMA ORDINARY ML PRE-
ICALS LTD DIVISION)-PLOT NO. PRE-FILLED FILLED
423/P/A, SARKHEJ-BAVLA SYRINGES SYRINGE
HIGHWAY, MORAIYA,
TALUKA SANAND,
AHMEDABAD- 382213,
GUJARAT
3467 NDA/MAL/H TWENTY SWASTIK XOMOX CV AMOXICILLIN 250MG+12 TWENTY FIRST CENTURY INDIA ORAL SOLID 1.0X2.0X1 7/1/2017
DP/7376 FIRST PHARMACEUTIC 375 +POTASSIUM 5MG PHARMACEUTICALS ORDINARY 0.0
CENTURY AL LTD CLAVULANAT PVT.LTD-UNIT II, KHASRA FILM- TABLET
PHARMACEUT E NO: 282, NALHERI COATED STRIP
ICALS PVT.LTD DEHVIRAN, TABLETS
NALHERA
ANANTPUR,PUHANA -
IQBALPUR ROAD,
ROORKEE
3468 NDA/MAL/H TWENTY SWASTIK XOMOX DS AMOXICILLIN 125MG/5 TWENTY FIRST CENTURY INDIA ORAL LIQUID 1.0X100.0 7/1/2017
DP/7377 FIRST PHARMACEUTIC TRIHYDRATE ML PHARMACEUTICALS ORDINARY ML
CENTURY AL LTD PVT.LTD-UNIT II, KHASRA DRY BOTTLE
PHARMACEUT NO: 282, NALHERI SUSPENSION
ICALS PVT.LTD DEHVIRAN, S/SYRUPS/D
NALHERA ROPS
ANANTPUR,PUHANA -
IQBALPUR ROAD,
ROORKEE
3469 NDA/MAL/H ALKEM ABACUS OLKEM 20 OLMESARTAN 20MG ALKEM LABORATORIES INDIA ORAL SOLID 1.0X3.0X1 11/28/2019
DP/7383 LABORATORIE PHARMA MEDOXOMIL LTD .,.-VILLAGE THANA ORDINARY 0.0
S LIMITED (AFRICA) BADDI DIST-SOLAN TEHSIL FILM- TABLET
LIMITED NALAGARH HIMACHAL COATED BLISTER
PRADESH 173205 TABLETS
3470 NDA/MAL/H TWENTY SWASTIK TRYOXIM CEFUROXIME 125MG/5 TWENTY FIRST CENTURY INDIA ORAL LIQUID 1.0X100.0 7/1/2017
DP/7385 FIRST PHARMACEUTIC DS AXETL ML PHARMACEUTICALS PVT ORDINARY ML
CENTURY AL LTD LTD--ROORKEE DISTT DRY BOTTLE
ROPS
3471 NDA/MAL/H TWENTY SWASTIK TRYLEXIN CEFALEXIN 125MG/5 TWENTY FIRST CENTURY INDIA ORAL LIQUID 1.0X100.0 7/1/2017
DP/7386 FIRST PHARMACEUTIC 125 DS MONOHYDRA ML PHARMACEUTICALS PVT ORDINARY ML
CENTURY AL LTD TE LTD--ROORKEE DISTT DRY BOTTLE
ROPS
3472 NDA/MAL/H ZIM GITTOES CEFRIM 250 CEFUROXIME 250MG ZIM LABORATORIES INDIA ORAL SOLID 1.0X1.0X1 11/28/2019
DP/7387 LABORATORIE PHARMACEUTIC AXETIL LIMITED-B-21/22 MIDC ORDINARY 0.0
S LTD ALS LIMITED AREA KALMESHWAR TABLETS TABLET
441501, DIST NAGPUR, BLISTER
MAHARASHTRA
3473 NDA/MAL/H TWENTY SWASTIK TRYFIX CV CEFIXIME+CL 200MG+12 TWENTY FIRST CENTURY INDIA ORAL SOLID 1.0X2.0X1 7/1/2017
DP/7388 FIRST PHARMACEUTIC 200 AVULANIC 5MG PHARMACEUTICALS PVT ORDINARY 0.0
CENTURY AL LTD ACID LTD--ROORKEE DISTT FILM- TABLET
PHARMACEUT HARIDWAR COATED STRIP
ICALS PVT.LTD TABLETS
3474 NDA/MAL/H EVA PHARMA GAMA GAROPRIDE ITOPRIDE 50MG EVA PHARMA FOR EGYPT ORAL SOLID 1.0X3.0X1 11/28/2019
DP/7389 FOR PHARMACEUTIC HYDROCHLOR PHARMACEUTICALS AND ORDINARY 0.0
PHARMACEUT ALS (U) LIMITED IDE MEDICAL APPLIANCES-176 TABLETS TABLET
ICALS & EL SADAT ST. KAFR EL BLISTER
APPLIANCES - EGYPT
3475 NDA/MAL/H ASTRA ASTRA PHARMA CIDOPRAZ ESOMEPRAZO 40MG ASTRA LIFECARE (INDIA) INDIA ORAL SOLID 1.0X15.0 11/28/2019
DP/7390 LIFECARE (U) LIMITED LE PVT. LTD'-PLOT 57 / P, ORDINARY TABLET
(INDIA) PVT. SARKHEJ - BAVLA TABLETS BLISTER
LTD HIGHWAY RAJODA
AHMEDABA
3476 NDA/MAL/H EMCURE HARLEYS TAVIN-EM TENOFOVIR 300MG + EMCURE INDIA ORAL SOLID 1.0X1.0X3 1/25/2019
DP/7391 PHARMACEUT UGANDA DISOPROXIL 200MG PHARMACEUTICALS LTD .- ORDINARY 0.0
ICALS LTD LIMITED FUMARATE + PLOT NO. P-2 IT-BT PARK FILM- TABLET
EMTRICITABI PHASE II MIDC HINJWADI COATED CONTAIN
NE PUNE 411057 TABLETS ER
3477 NDA/MAL/H AXA VITACARE AXADEX GLUCOSE 50%W/V AXA PARENTERALS LTD- INDIA PARENTERAL 1.0X100.0 11/28/2019
DP/7394 PARENTERALS LIMITED (D50%) ANHYDROUS PLOT NO. 936, 937 & 939, ORDINARY ML
UTTARAKHAND
3478 NDA/MAL/H PLANET PLANET ACE KIT MIFEPRISTON 200MG + ACME FORMULATION PVT INDIA ORAL SOLID 1.0X5.0 12/5/2019
DP/7395 PHARMACEUT PHARMACEUTIC E+ 20MCG LTD -ROPAR ROAD, ORDINARY TABLET
ICALS (U) LTD ALS UGANDA MISOPROSTO NALAGARH DISTT. SOLAN TABLETS BLISTER
LTD L HP-174101
3479 NDA/MAL/H MYLAN KIMSY MEDS ABACAVIR ABACAVIR 60 MG /30 MYLAN LABORATORIES INDIA ORAL SOLID 1.0X60.0 7/1/2018
DP/7403 LABORATORIE LTD SULFATE SULFATE / MG LTD .-F/4 & F/12, ORDINARY TABLET
S LIMITED /LAMIVUDI LAMIVUDINE MALEGAON MIDC, SOLUBLE BOTTLE
NE SINNAR, NASHIK-422 113, TABLETS
DISPERSIBL MAHARASHTRA
E TABLETS
60MG/30M
G
3480 NDA/MAL/H ABACUS ABACUS ARENA ADRENALINE 0.1% W/V LINCOLN PARENTERAL LTD INDIA PARENTERAL 1.0X10.0X 7/1/2017
DP/7406 PARENTERAL PARENTERAL -11 TRIUL ESTATE ORDINARY 1.0 ML
DRUGS DRUGS LIMITED KHATRAJ TAL KALOL DIST AMPOULES AMPOULE
LIMITED GANDHINAGAR GUJARAT
3481 NDA/MAL/H HETERO LABS AIVEEN (U) MONAST 5 MONTELUKAS 5MG HETERO LABS LIMITED INDIA ORAL SOLID 1.0X3.0X1 11/28/2019
DP/7407 LTD LIMITED T SODIUM (UNIT V)-SY NO. 436,440, ORDINARY 0.0
POLEPALLY (V),
JEDCHERLA (M),
MAHABOOBNAGAR,
DISTRICT ANDHRA
PRADESH 509301
3482 NDA/MAL/H ZIM GITTOES ZIFLAM 100 ACECLOFENA 100MG ZIM LABORATORIES INDIA ORAL SOLID 1.0X3.0X1 11/28/2019
DP/7408 LABORATORIE PHARMACEUTIC C LIMITED-B-21/22 MIDC ORDINARY 0.0
S LTD ALS LIMITED AREA KALMESHWAR FILM- TABLET
441501, DIST NAGPUR, COATED BLISTER
MAHARASHTRA TABLETS
3483 NDA/MAL/H S K AGE ABACUS LARIACT ARTEMETHER 20MG + S KANT HEALTHCARE LTD- INDIA ORAL SOLID 1.0X6.0 11/28/2019
DP/7409 EXPORTS PHARMA DISPERSIBL + 120MG PLOT NO. 1805, G.I.D.C ORDINARY TABLET
(AFRICA) E LUMEFANTRI PHASE III, VAPI 396195, SOLUBLE BLISTER
LIMITED NE GUJARAT TABLETS
3484 NDA/MAL/H MEDOPHARM PLANET COTRIMOX TRIMETHOPRI 960MG MEDOPHARM --34 B, INDIA ORAL SOLID 1.0X10.0X 9/26/2018
DP/7410 , INDIA PHARMACEUTIC AZOLE M INDUSTRIAL AREA, MALUR ORDINARY 10.0
ALS UGANDA TABLETS BP +SULPHAMET - 563160, TABLETS TABLET
LTD 960 MG HOXAZOLE KARNATAKA, INDIA. BLISTER,1.
0X50.0X10
.0 TABLET
BLISTER,1.
0X100.0X1
0.0
TABLET
BLISTER,1.
0X1000.0
3485 NDA/MAL/H S K AGE ABACUS LARIACT ARTEMETHER 180MG + S KANT HEALTHCARE LTD- INDIA ORAL LIQUID 1.0X60.0 11/28/2019
DP/7411 EXPORTS PHARMA 180-1080 + 1080MG PLOT NO. 1805, G.I.D.C ORDINARY ML
(AFRICA) LUMEFANTRI /60ML PHASE III, VAPI 396195, DRY BOTTLE
LIMITED NE GUJARAT SUSPENSION
S/SYRUPS/D
ROPS
3486 NDA/MAL/H S K AGE ABACUS LARIACT DS ARTEMETHER 40MG + S KANT HEALTHCARE LTD- INDIA ORAL SOLID 1.0X12.0 11/28/2019
DP/7412 EXPORTS PHARMA + 240MG PLOT NO. 1805, G.I.D.C ORDINARY TABLET
(AFRICA) LUMEFANTRI PHASE III, VAPI 396195, SOLUBLE BLISTER
LIMITED NE GUJARAT TABLETS
3487 NDA/MAL/H S K AGE ABACUS LARIACT ARTEMETHER 20MG + S KANT HEALTHCARE LTD- INDIA ORAL SOLID 1.0X24.0 11/28/2019
DP/7413 EXPORTS PHARMA + 120MG PLOT NO. 1805, G.I.D.C ORDINARY TABLET
(AFRICA) LUMEFANTRI PHASE III, VAPI 396195, TABLETS BLISTER
LIMITED NE GUJARAT
3488 NDA/MAL/H KHANDELWAL SURGIPHARM RIBOREA HYDROXYURE 500MG KHANDELWAL INDIA ORAL SOLID 1.0X10.0X 11/28/2019
DP/7414 LABORATORIE (U) LIMITED A LABORATORIES PVT. LTD-B- ORDINARY 10.0
S PVT 1, WAGLE INDUSTRIAL CAPSULES CAPSULE
LIMITED ESTATE, THANE – 400 604 BLISTER
INDIA
3489 NDA/MAL/H KHANDELWAL SURGIPHARM MAMOFEN- TAMOXIFEN 20MG KHANDELWAL INDIA ORAL SOLID 1.0X10.0X 11/28/2019
DP/7415 LABORATORIE (U) LIMITED 20 CITRATE LABORATORIES PVT. LTD-B- ORDINARY 10.0
S PVT 1, WAGLE INDUSTRIAL TABLETS TABLET
LIMITED ESTATE, THANE – 400 604 STRIP
INDIA
3490 NDA/MAL/H FDC LTD UNITED RESTORS ORAL MULTI- FDC LIMITED - GOA III- INDIA ORAL SOLID 1.0X2.0X2 11/28/2019
DP/7416 HEALTHCARE ORAL REHYDRATIO INGREDIEN PHASE III/A, PLOT NO. L- ORDINARY 1.8 G
DISTRIBUTORS REHYDRATI N SALTS + T 121/B, SALCETTE, VERNA UNIT DOSE SACHET
LTD ON SALTS ZINC INDUSTRIAL ESTATE, POWDERS +(1*10
ZINKID CO- SULPHATE VERNA, GOA-403722 FDC ALU-PVC
PACK( LTD.-L-56&L-57, PHASE II- BLISTERS
ORANGE D, VERNA INDUSTRIAL ZINC
FLAVOUR) ESTATE, VERNA-403 722, SULPHATE
SALCETE, GOA )
3491 NDA/MAL/H INTAS AIVEEN (U) SARTEL-40 TELMISARTA 40MG INTAS PHARMACEUTICALS INDIA ORAL SOLID 1.0X3.0X1 11/28/2019
DP/7417 PHARMACEUT LIMITED N LTD ...,-CAMP ROAD, ORDINARY 0.0
ICALS LTD SELAQUI, DEHRADUN- TABLETS TABLET
248197, UTTARKHAND BLISTER
3492 NDA/MAL/H INTAS AIVEEN (U) FOLISURGE FOLLITROPIN 1200 INTAS PHARMACEUTICALS INDIA PARENTERAL 1.0X2.0 11/28/2019
DP/7418 PHARMACEUT LIMITED 1200 ALFA IU/1.92ML LTD (BIOPHARMA ORDINARY ML PRE-
ICALS LTD DIVISION)-PLOT NO. PRE-FILLED FILLED
423/P/A, SARKHEJ-BAVLA SYRINGES SYRINGE
HIGHWAY, MORAIYA,
TALUKA SANAND,
AHMEDABAD- 382213,
GUJARAT
3493 NDA/MAL/H INTAS AIVEEN (U) PACLITAXEL CARBAMAZEP 200MG INTAS PHARMACEUTICALS INDIA PARENTERAL 1.0X16.7 11/28/2019
DP/7419 PHARMACEUT LIMITED INE LTD ...,-CAMP ROAD, ORDINARY ML VIAL
ICALS LTD SELAQUI, DEHRADUN- INFUSION
248197, UTTARKHAND VIALS/BOTTL
ES
3494 NDA/MAL/H PINNACLE METRO GESIC ADL IBUPROFEN 200MG PINNACLE LIFE SCIENCE INDIA ORAL SOLID 1.0X10.0X 7/1/2017
3495 NDA/MAL/H MACLEODS NORVIK ZINC ZINC SULFATE 20MG MACLEODS INDIA ORAL SOLID 1.0X10.0X 7/1/2017
DP/7424 PHARMACEUT ENTERPRISES SULFATE MONOHYDRA PHARMACEUTICALS LTD - - ORDINARY 10.0
ICALS LTD LIMITED TABLETS TE VILLAGE THEDA P.O SOLUBLE TABLET
USP 20MG LODHIMAJRA TEHSIL TABLETS BLISTER
BADDI DISTRICT SOLAN
HIMACHAL PRADESH
INDIA 174101
3496 NDA/MAL/H AUROCHEM AIVEEN (U) DOLOACT ACECLOFENA 100MG + AUROCHEM INDIA ORAL SOLID 1.0X3.0X1 11/28/2019
DP/7425 LABORATORIE LIMITED PLUS C+ 500MG PHARMACEUTICALS (I)- ORDINARY 0.0
S(I) PVT LTD PARACETAM PLOT NO. 58, PTICE LTD TABLETS TABLET
OL PALGHAR 401404, BLISTER
MAHARASHTRA
3497 NDA/MAL/H MEDOCHEMIE BOOTS MEDOFED GUAIFENESIN 100MG + MEDOCHEMIE CYPRUS ORAL LIQUID 1.0X100.0 11/28/2019
DP/7426 LTD PHARMACEUTIC + 15MG + ACTORY).....-1-10 ORDINARY ML
ALS LIMITED DEXTROMET 20MG + CONSTANTINOUPOLEOS LIQUIDS BOTTLE
HORPHAN 1.25MG/5 STREET, 3011, LIMASSOL
HYDROBROM ML
IDE +
PSEUDOEPHE
DRINE
HYDROCHLOR
IDE AND +
TRIPROLIDINE
HYDROCHLOR
3498 NDA/MAL/H CIPLA LTD. QUALITY EFAVIRENZ EFAVIRENZ + 400MG + CIPLA LTD ,.-PLOT NO. A- INDIA ORAL SOLID 1.0X30.0 11/28/2019
DP/7427 CHEMICALS LTD - + LAMIVUDINE 300MG + 33, A-2 (UNIT 1), A42 ORDINARY TABLET
HUMAN LAMIVUDIN + TENOFOVIR 300MG (UNIT II), MIDC TABLETS BOTTLE
E+ DISOPROXIL PATALGANGA, DISTRICT-
TENOFOVIR FUMARATE RAIGAD MAHARASHTRA,
DISOPROXIL 410220 INDIA
FUMARATE
3499 NDA/MAL/H PSA ROYAL PHARMA TELPERZID TELMISARTA 40MG + ZIM LABORATORIES INDIA ORAL SOLID 1.0X3.0X1 11/28/2019
DP/7428 INTERNATION 2011 LIMITED N+ 12.5MG LIMITED-B-21/22 MIDC ORDINARY 0.0
AL (EXPORT HYDROCHLOR AREA KALMESHWAR TABLETS TABLET
DIVISION OF OTHIAZIDE 441501, DIST NAGPUR, BLISTER
PSA MAHARASHTRA
CHEMICALS
AND
PHARMACEUT
ICALS PVT.
LTD)
3500 NDA/MAL/H SAKAR ROYAL PHARMA CEFTRIAXO CEFTRIAXONE 1G SAKAR HEALTHCARE PVT INDIA PARENTERAL 1.0X1.0 G 11/28/2019
DP/7429 HEALTHCARE 2011 LIMITED NE SODIUM LTD-BLOCK NO. 10-13, NR. ORDINARY VIAL +
LIMITED M.N DESAI PETRO PUMP, DRY VIALS 1*10ML
SARKHEJ-BAVLA ROAD, AMPOULE
CHANGODAR, DIST: WFI
AHMEDABAD-382213,
GUJARAT
3501 NDA/MAL/H WIN- SURGIPHARM MOVICOL MACROGOL 13.125G+3 WIN-MEDICARE PVT. LTD- INDIA ORAL LIQUID 1.0X10.0X 9/26/2018
DP/7431 MEDICARE (U) LIMITED 3350 50.7MG+1 MODIPURAM-250 110, ORDINARY 13.81 G
PVT LTD (POLYETHYLE 78.5MG+4 UTTAR PRADESH,INDIA SOLUBLE SACHET
NE 6.6MG POWDERS
GLYCOL)+SOD
IUM
CHLORIDE+SO
DIUM
BICARBONAT
E+
POTASSIUM
CHLORIDE
3502 NDA/MAL/H SERUM NORVIK MENAFRIV MENINGOCO 5µG + 5µG SERUM INSTITUTE OF INDIA PARENTERAL 1.0X5.0 11/28/2019
DP/7432 INSTITUTE OF ENTERPRISES AC CCAL A /0.5ML INDIA PVT LTD .-212/2, ORDINARY ML VIAL +
INDIA PVT LIMITED POLYSACCHA HADAPSAR, PUNE- DRY VIALS 1*5ML
LTD RIDE + 411028, INDIA AMPOULE
TETANUS FOR
TOXOID DILUENT
3503 NDA/MAL/H FRESENIUS SURGIPHARM KETOSTERIL MULTIINGRE MULTIING LABESFAL LABORATORIOS PORTUGAL ORAL SOLID 1.0X5.0X2 11/28/2019
DP/7433 KABI (U) LIMITED DIENT REDIENT SLMIRO, S.A ,.-ZONA ORDINARY 0.0
MANUFACTU INDUSTRIAL DO LAGEDO TABLETS TABLET
RING S.A 3465-157 SANTIAGO DE BLISTER
(PTY) LTD BESTEIROS
3504 NDA/MAL/H NEOMI EUROPA NEOMICEF CEFTRIAXONE 1G ZEISS PHARMACEUTICALS INDIA PARENTERAL 1.0X1.0 G 11/28/2019
DP/7434 PHARMACEUT HEALTHCARE SODIUM PVT LTD - -PLOT 72, EPIP, ORDINARY VIAL
ICALS PVT LTD (U) LTD PHASE 1, JHARMAJRI DRY VIALS
BADDI, 173205, DIST:
SOLAN HIMACHAL
PRADESH, INDIA
3505 NDA/MAL/H SQUARE GAMA ZIMAX AZITHROMYCI 200MG/5 ZIM LABORATORIES INDIA ORAL LIQUID 1.0X30.0 11/28/2019
DP/7435 FORMULATIO PHARMACEUTIC N DIHYDRATE ML LIMITED-B-21/22 MIDC ORDINARY ML
NS LTD ALS (U) LIMITED AREA KALMESHWAR LIQUIDS BOTTLE
441501, DIST NAGPUR,
MAHARASHTRA
3506 NDA/MAL/H SQUARE GAMA CEFOTIL CEFUROXIME 500MG + SQUARE CEPALOSPORINS INDIA ORAL SOLID 1.0X1.0X6 11/28/2019
DP/7436 PHARMACEUT PHARMACEUTIC PLUS 500 AXETIL + 125MG LTD..-KALIAKOIR GAZIPUR ORDINARY .0 TABLET
ICALS LTD ALS (U) LIMITED CLAVULANAT TABLETS BLISTER
E
3507 NDA/MAL/H SQUARE GAMA CEFOTIL CEFUROXIME 250MG + SQUARE CEPALOSPORINS INDIA ORAL SOLID 1.0X1.0X1 11/28/2019
DP/7437 PHARMACEUT PHARMACEUTIC PLUS 250 AXETIL + 62.5MG LTD..-KALIAKOIR GAZIPUR ORDINARY 0.0
ICALS LTD ALS (U) LIMITED CLAVULANAT TABLETS TABLET
E BLISTER
3508 NDA/MAL/H DAWA SUPER MEDIC LORVIC LORATADINE 5MG/5ML DAWA LIMITED-16633- KENYA ORAL LIQUID 1.0X60.0 11/28/2019
DP/7439 PHARMACEUT LTD 00620, RUARAKA, BABA ORDINARY ML
ICALS LIMITED DOGO ROAD, NAIROBI SYRUPS BOTTLE
3509 NDA/MAL/H MANKIND TATA UGANDA TOTACEF- CEFEPIME 1000MG MANKIND PHARMA LTD.- INDIA PARENTERAL 1.0X1000. 11/28/2019
DP/7440 LIMITED 1000 VILLAGE KISHANPURA, RETARD DRY 0 MG VIAL
POAMTA SAHI DISTRICT VIALS
SIRMOUR HIMACHAL
PRADESH
3510 NDA/MAL/H VIRCHOW SURGIPHARM HYORTH XL SODIUM 8MG/ML VIRCHOW BIOTECH PVT INDIA PARENTERAL 1.0X6.0 11/29/2017
DP/7441 HEALTHCARE (U) LIMITED HYALURONAT LTD-SURVEY NO. 172, ORDINARY ML PRE-
PVT LTD E PART GAGILLAPUR(P) PRE-FILLED FILLED
QUTHBULLAPUR(MANDAL SYRINGES SYRINGE
), R.R, DISTRICT,
TELANGANA STATE,
500043.INDIA
3511 NDA/MAL/H DAWA SUPER MEDIC NERVILIN PREGABALIN 75MG + DAWA LIMITED-16633- KENYA ORAL SOLID 1.0X3.0X1 11/28/2019
DP/7442 LIMITED- LTD NT + 10MG 00620, RUARAKA, BABA ORDINARY 0.0
NORTRIPTYLI DOGO ROAD, NAIROBI TABLETS TABLET
NE BLISTER
HYDROCHLOR
IDE
3512 NDA/MAL/H DAWA SUPER MEDIC GOUTSTAT FEBUXOSTAT 40MG DAWA LIMITED-16633- KENYA ORAL SOLID 1.0X1.0X1 11/28/2019
DP/7443 LIMITED- LTD 40 00620, RUARAKA, BABA ORDINARY 0.0
DOGO ROAD, NAIROBI TABLETS TABLET
BLISTER
3513 NDA/MAL/H AXA VITACARE FRESH EYES CARMELLOSE 0.5%W/V AXA PARENTERAL LIMITED- INDIA OPHTHALMI 1.0X1.0X1 12/20/2018
DP/7444 PARENTERALS LIMITED SODIUM PLOT NO.936,937&939, C DROPS 0.0 ML
LTD VILL. KISHANPUR, VIAL
JAMALPUR,ROORKEE
247667, DISTT. HARIDWAR
3514 NDA/MAL/H DAWA SUPER MEDIC GOUTSTAT FEBUXOSTAT 80MG DAWA LIMITED-16633- KENYA ORAL SOLID 1.0X1.0X1 11/28/2019
DP/7445 LIMITED- LTD 80 00620, RUARAKA, BABA ORDINARY 0.0
BLISTER
3515 NDA/MAL/H PINNACLE ABACUS LORADIN LORATADINE 10MG PINNACLE LIFE SCIENCE INDIA ORAL SOLID 1.0X10.0X 11/28/2019
DP/7447 LIFE SCIENCE PHARMA 10 PVT LTD-KHASRA NO. ORDINARY 10.0
PVT. LTD (AFRICA) 1328-1330, VILLAG TABLETS TABLET
LIMITED MANPURA, TEHSIL, BADDI, BLISTER
DIST. SOLAN (HP)
3516 NDA/MAL/H OCHOA SUPER MEDIC SORID CALCIPOTRIO 50MCG AUROCHEM INDIA TOPICAL 1.0X30.0 11/29/2017
DP/7448 LABORATORIE LTD OINTMENT L +0.5MG PHAMACEAUTICALS (1) EXTERNAL G TUBE
S MONOHYDRA LTD-58 PALGHAR TALUKA OINTMENTS
TE + INDUSTRIAL CO-
BETAMETHAS OEPERATIVE ESTATE LTD
ONE BOISAR RD PALGHAR DIST
DIPROPIONAT THANE 401404 INDIA
E
3517 NDA/MAL/H CIPLA CIPLA QUALITY LAMIVUDIN LAMIVUDINE 300MG+30 CIPLA QUALITY UGANDA ORAL SOLID 1.0X30.0 1/31/2018
DP/7449 QUALITY CHEMICAL E/ +TENOFOVIR 0MG CHEMICALS INDUSTRIES ORDINARY TABLET
CHEMICAL INDUSTRIES TENOFOVIR DISOPROXIL LIMITED--PLOT 1-7 1ST FILM- BOTTLE
INDUSTRIES LIMITED DF FUMARATE RING ROAD, LUZIRA COATED
LIMITED 300/300MG INDUSTRIAL PARK P O BOX TABLETS
34871, KAMPALA,
UGANDA
3518 NDA/MAL/H OCHOA SUPER MEDIC DOLOACT KETOPROFEN 2.50%W/W AUROCHEM INDIA TOPICAL 1.0X30.0 11/29/2017
DP/7450 LABORATORIE LTD GEL + CAPSICUM + LABORATORIES (I) PVT LTD- EXTERNAL G TUBE
S OLEORESIN 0.25%W/W -8 PALGHAR TALUKA GELS AND
INDUSTRIAL CO-OP SOLS
404 DIST THANE
3519 NDA/MAL/H AKRITI ROYAL PHARMA MYTHRO AZITHROMYCI 500MG AKRITI INDIA ORAL SOLID 1.0X1.0X3 11/28/2019
DP/7451 PHARMACEUT 2011 LIMITED 500 N DIHYDRATE PHARMACEUTICALS PVT ORDINARY .0 TABLET
ICALS PVT LTD LTD-PLOT NO. D-10 & 11, FILM- BLISTER
MIDC, JEJURI, TAL. COATED
PURANDAR, DIST. PUNE TABLETS
(MAHARASHTRA) INDIA
3520 NDA/MAL/H OCHOA SUPER MEDIC XTRADERM BETAMETHAS 0.64 MG/1 AUROCHEM INDIA TOPICAL 1.0X20.0 11/29/2017
DP/7452 LABORATORIE LTD CREAM ONE G + 0.1 LABORATORIES LTD -PLOT EXTERNAL G
S DIPROPIONAT MG/1 G + 08 PALGHAR 401404 CREAMS TUBE,1.0X
E+ 10 MG/1 G MAHARASHTRA, INDIA 15.0 G
GENTAMICIN TUBE,1.0X
SULFATE + 10.0 G
CLOTRIMAZO TUBE
LE
3521 NDA/MAL/H GLOBAL NAPI WIDE ANTIDIAZO NITAZOXANID 100MG/5 GLOBAL NAPI EGYPT ORAL LIQUID 1.0X60.0 7/1/2017
DP/7453 PHARMACEUT SPECTRUM X E ML PHARMACEUTICALS -2ND ORDINARY ML
ICALS ENTERPRISES INDUSTRIAL ZONE, NO.40, DRY BOTTLE
(U) LIMITED ST. NO 18, 6TH OCTOBER, SUSPENSION
GIZA, S/SYRUPS/D
ROPS
3522 NDA/MAL/H MEDISEL(K) AIVEEN (U) GIT ITOPRIDE 150MG CORONA REMEDIES PVT. INDIA OPHTHALMI 1.0X1.0X1 11/28/2019
DP/7454 LTD LIMITED HYDROCHLOR LTD-VILLAGE JATOLI, POST C DROPS 0.0
IDE OFFICE- OACHGHAT, TABLET
TEHSIL, SOLAN, DISTT. BLISTER
SOLAN (H.P) 173223
3523 NDA/MAL/H INFUGEN TATA UGANDA INFUTRAX CEFTRIAXONE 1G M/S ZEISS INDIA PARENTERAL 1.0X1.0 G 11/28/2019
DP/7456 PHARMA PVT. LIMITED SODIUM PHARMACEUTICALS PVT ORDINARY VIAL
LTD. LTD,,-PLOT 72, EPIP PHASE DRY VIALS
1, JHARMAJRI BADDI, DIST:
SOLAN HP-INDIA
3524 NDA/MAL/H CIPLA LTD. QUALITY CIPLADON PARACETAM 1000MG CIPLA LTD ,,-PLOT NO. INDIA ORAL SOLID 1.0X6.0X4 11/28/2019
DP/7457 CHEMICALS LTD - OL 9,10,15 INDORE SPECIAL ORDINARY .0 TABLET
HUMAN EFFERVESCEN ECONOMIC ZONE PHASE II EFFERVESCE BLISTER
T PITHAMPUR DISTRICT NT TABLETS
DHAR MADHYA PRADESH
PIN. 454775
3525 NDA/MAL/H HETERO AIVEEN (U) DERISE™25 DARBEPOETI 25MCG/0.4 HETERO LABS LIMITED INDIA PARENTERAL 1.0X0.42 11/28/2019
DP/7458 DRUGS LTD LIMITED N ALFA 2ML (UNIT V)-SY NO. 436,440, ORDINARY ML PRE-
441 & 458, APIIC PRE-FILLED FILLED
FORMULATION SEZ, SYRINGES SYRINGE
POLEPALLY (V), (SINGLE
JEDCHERLA (M), DOSE)
MAHABOOBNAGAR,
DISTRICT ANDHRA
PRADESH 509301
3526 NDA/MAL/H HETERO AIVEEN (U) DERISE™40 DARBEPOETI 40MCG/0.4 HETERO LABS LIMITED INDIA PARENTERAL 1.0X0.2 11/28/2019
DP/7459 DRUGS LTD LIMITED N ALFA ML (UNIT V)-SY NO. 436,440, RETARD PRE- ML PRE-
441 & 458, APIIC FILLED FILLED
FORMULATION SEZ, SYRINGES SYRINGE
POLEPALLY (V),
JEDCHERLA (M),
MAHABOOBNAGAR,
DISTRICT ANDHRA
PRADESH 509301
3527 NDA/MAL/H INVENTIA EUROPA SEGABIN SR PREGABALIN 75MG INVENTIA HEALTHCARE INDIA ORAL SOLID 1.0X3.0X1 11/28/2019
DP/7460 HEALTHCARE HEALTHCARE 75 PVT LTD -F1-F1/1 ORDINARY 0.0
PVT LTD (U) LTD ADDITIONAL MIDC TABLETS TABLET
AMBERNATH (E) DIST. BLISTER
THANE
3528 NDA/MAL/H INVENTIA EUROPA SEGABIN SR PREGABALIN 150MG INVENTIA HEALTHCARE INDIA ORAL SOLID 1.0X3.0X1 11/28/2019
DP/7462 HEALTHCARE HEALTHCARE 150 PVT LTD -F1-F1/1 RETARD 0.0
PVT LTD (U) LTD ADDITIONAL MIDC TABLETS TABLET
AMBERNATH (E) DIST. BLISTER
THANE
3529 NDA/MAL/H BROOKES HARLEYS ACURON ATRACURIUM 10MG/ML BROOKES PHARMA PAKISTAN PARENTERAL 1.0X5.0X5 8/28/2019
DP/7463 PHARMA UGANDA BESYLATE (PRIVATE) LIMITED-58-59, ORDINARY .0 ML
(PRIVATE) LIMITED SECTOR NO. 15, KORANGI AMPOULES AMPOULE
KARACHI-74900
3530 NDA/MAL/H INVENTIA EUROPA SEGABIN M PREGABALIN 75MG + INVENTIA HEALTHCARE INDIA ORAL SOLID 1.0X3.0X1 11/28/2019
DP/7464 HEALTHCARE HEALTHCARE 75 + 1500MCG PVT LTD -F1-F1/1 RETARD 0.0
PVT LTD (U) LTD METHYCOBAL ADDITIONAL MIDC TABLETS TABLET
AMIN AMBERNATH (E) DIST. BLISTER
THANE
3531 NDA/MAL/H HETERO AIVEEN (U) VALSAR HT VALSARTAN + 80MG + HETERO LABS LIMITED INDIA ORAL SOLID 1.0X3.0X1 11/28/2019
DP/7466 DRUGS LTD LIMITED 80/12.5 HYDROCHLOR 12.5MG (UNIT V)-SY NO. 436,440, ORDINARY 0.0
OTHIAZIDE 441 & 458, APIIC TABLETS TABLET
POLEPALLY (V),
JEDCHERLA (M),
MAHABOOBNAGAR,
DISTRICT ANDHRA
PRADESH 509301
3532 NDA/MAL/H BROOKES HARLEYS TEZOLE KETOCONAZO 20 MG BROOKES PHARMA PAKISTAN TOPICAL 1.0X10.0 8/28/2019
DP/7467 PHARMA UGANDA CREAM LE (PRIVATE) LIMITED-58-59, EXTERNAL G TUBE
(PRIVATE) LIMITED SECTOR NO. 15, KORANGI CREAMS
KARACHI-74900
3533 NDA/MAL/H AKRITI ROYAL PHARMA GYNO PLUS METRONIDAZ 100MG + AKRITI INDIA VAGINAL 1.0X1.0X1 11/28/2019
DP/7468 PHARMACEUT 2011 LIMITED OLE + 100MG PHARMACEUTICALS PVT TABLETS 0.0
ICALS PVT LTD MICONAZOLE LTD-PLOT NO. D-10 & 11, TABLET
NITRATE MIDC, JEJURI, TAL. BLISTER
PURANDAR, DIST. PUNE
(MAHARASHTRA) INDIA
3534 NDA/MAL/H AKRITI ROYAL PHARMA AKSONE CEFTRIAXONE 1G AKRITI INDIA PARENTERAL 1.0X1.0 G 11/28/2019
DP/7470 PHARMACEUT 2011 LIMITED SODIUM PHARMACEUTICALS PVT ORDINARY VIAL
ICALS PVT LTD LTD-PLOT NO. D-10 & 11, DRY VIALS
MIDC, JEJURI, TAL.
(MAHARASHTRA) INDIA
3535 NDA/MAL/H AMRING ERIS LTD BEVACIZUMA 100 MG/4 SINERGIUM BIOTECH SA- ARGENTINA PARENTERAL 1.0X1.0X4 11/27/2019
DP/7471 FARMA S.R.L BEVACIZU B ML RUTA PANAMERICANA ORDINARY .0 ML
MAB KM 38.7 GARIN BUENOS VIALS VIAL
AMRING AIRES, MABXIENCE S.A.U-
CARLOS VILLAGE 5148
MUNRO, BUENOS AIRES
B16054XL
3536 NDA/MAL/H AMRING ERIS LTD 400 MG/16 SINERGIUM BIOTECH SA- ARGENTINA PARENTERAL 1.0X1.0X1 11/27/2019
DP/7472 FARMA S.R.L BEVACIZU BEVACIZUMA ML RUTA PANAMERICANA ORDINARY 6.0 ML
MAB B KM 38.7 GARIN BUENOS VIALS VIAL
AMRING AIRES, MABXIENCE S.A.U-
CARLOS VILLAGE 5148
MUNRO, BUENOS AIRES
B16054XL
3537 NDA/MAL/H INVENTIA EUROPA AFLODOR ACECLOFENA 200MG + INVENTIA HEALTHCARE INDIA ORAL SOLID 1.0X6.0X5 11/27/2019
DP/7473 HEALTHCARE HEALTHCARE 16 C+ 16MG PVT LTD -F1-F1/1 ORDINARY .0
PVT LTD (U) LTD THIOCOLCHIC ADDITIONAL MIDC CAPSULES CAPSULE
OSIDE AMBERNATH (E) DIST. BLISTER
THANE
3538 NDA/MAL/H INVENTIA EUROPA AFLODOR 8 ACECLOFENA 200 MG + INVENTIA HEALTHCARE INDIA ORAL SOLID 1.0X6.0X5 11/27/2019
DP/7474 HEALTHCARE HEALTHCARE C+ 8 MG PVT LTD -F1-F1/1 ORDINARY .0
PVT LTD (U) LTD THIOCOLCHIC ADDITIONAL MIDC CAPSULES CAPSULE
OSIDE AMBERNATH (E) DIST. BLISTER
THANE
3539 NDA/MAL/H UNI MEDICO SHREEJI UMOCLOX AMPICILLIN 250MG+25 UNI MEDICOLABS.- 21-22 INDIA ORAL SOLID 1.0X10.0X 7/1/2015
DP/7475 LAB PHARMACEUTIC 500 TRIHYDRATE+ 0MG PHARMACITY SELAQUI ORDINARY 10.0
ALS LIMITED CLOXACILLIN DEHRADUN 248197 CAPSULES CAPSULE
SODIUM BLISTER
3540 NDA/MAL/H AKRITI ROYAL PHARMA AKRIDOL CARVEDILOL 12.5 MG AKRITI INDIA ORAL SOLID 1.0X3.0X1 11/27/2019
DP/7476 PHARMACEUT 2011 LIMITED 12.5 PHARMACEUTICALS PVT ORDINARY 0.0
ICALS PVT LTD LTD-PLOT NO. D-10 & 11, TABLETS TABLET
MIDC, JEJURI, TAL. BLISTER
(MAHARASHTRA) INDIA
3541 NDA/MAL/H SANDOZ SURGIPHARM SIMVASTAT SIMVASTATIN 20MG SANDOZ GRUP SAGLIK - TURKEY ORAL SOLID 1.0X3.0X1 7/1/2017
DP/7478 GMBH, (U) LIMITED IN 20 MG GEBZE 2 GOSB IHSAN ORDINARY 0.0
KUNDL FILM- DEDE CAD. 900. SOK FILM- TABLET
COATED 41480 GEBZE KOCAELI COATED BLISTER
TABLETS TABLETS
3542 NDA/MAL/H MYLAN KIMSY MEDS ALLTERA 50 LOPINAVIR + 40MG + MYLAN LABORATORIES INDIA ORAL SOLID 1.0X120.0 11/27/2019
DP/7479 LABORATORIE LTD RITONAVIR 10MG / LTD .-F/4 & F/12, ORDINARY SACHET
S LIMITED SACHET MALEGAON MIDC, GRANULES CARTON
SINNAR, NASHIK-422 113,
MAHARASHTRA
3543 NDA/MAL/H DEVA SHREEJI AMOKLAVI AMOXICILLIN 200MG + DEVA HOLDING A.S- TURKEY ORAL LIQUID 1.0X70.0 11/27/2019
DP/7480 HOLDING A.S PHARMACEUTIC N BID TRIHYDRATE 28.5MG/5 CERKEZKOY ORGANIZE ORDINARY ML
ALS LIMITED + POTASSIUM ML SANAYI BOLGESI, DRY BOTTLE
CLAVULANAT KARAAGAC MAH., SUSPENSION
E ATATURK CAD., NO.: 32 S/SYRUPS/D
KAPAKLI TEKIRDAG ROPS
3544 NDA/MAL/H INTAS NORVIK INTAGRA SILDENAFIL 100MG INTAS PHARMACEUTICALS INDIA ORAL SOLID 1.0X4.0 7/1/2017
DP/7481 PHARMACEUT ENTERPRISES 100 CIRATE LTD .-PLOT NOS. 457, 458 ORDINARY TABLET
ICALS LTD LIMITED & 191/218P SARKHEJ- FILM- BLISTER
BAVLA HIGHWAY COATED
MATODA SANAND TABLETS
AHMEDABAD GUJARAT
3545 NDA/MAL/H OCHOA SUPER MEDIC FUSIGO-B FUSIDIC ACID AUROCHEM INDIA TOPICAL 1.0X15.0 11/29/2017
DP/7482 LABORATORIE LTD CREAM BP AND 2.0%W/W+ LABORATORIES (I) PVT LTD- EXTERNAL G TUBE
S BETAMETHAS 0.1%W/W -8 PALGHAR TALUKA CREAMS
ONE INDUSTRIAL CO-OP
VALERATE BP ESTATE LTD PALGHAR 401
404 DIST THANE
3546 NDA/MAL/H AMMAN WIDE APISOPT DORZOLAMID 2%W/V + AMMAN JORDAN OPHTHALMI 1.0X5.0 11/27/2019
DP/7483 PHARMACEUT SPECTRUM PLUS E 0.5%W/V PHARMACEUTICALS C LIQUIDS ML VIAL
ICAL ENTERPRISES HYDROCHLOR INDUSTRIES-KING
INDUSTRIES (U) LIMITED IDE + ABDULLAH II, INDUSTRIAL
TIMOLOL ESTATE, SAHAB, AMMAN
MALEATE
3547 NDA/MAL/H CADILA ABACUS ATORVA AMLODIPINE 10MG + CADILA HEALTHCARE INDIA ORAL SOLID 1.0X3.0X1 11/27/2019
DP/7484 HEALTHCARE PHARMA AM 10/20 BESYLATE + 20MG LIMITED -KUNDAIM ORDINARY 0.0
LIMITED (AFRICA) ATORVASTATI INDUSTRIAL ESTATE,PLOT FILM- TABLET
LIMITED N CALCIUM NO.203-213, KUNDAIM COATED BLISTER
LTD (AFRICA) ATORVASTATI INDUSTRIAL ESTATE,PLOT FILM- TABLET
LIMITED N CALCIUM NO.203-213, KUNDAIM COATED BLISTER
LTD (AFRICA) ATORVASTATI INDUSTRIAL ESTATE,PLOT FILM- TABLET
LIMITED N CALCIUM NO.203-213, KUNDAIM COATED CARTON
3550 NDA/MAL/H ATCO HARLEYS BETASALIC BETAMETHAS 0.05%W/W ATCO LABS LTD,-B-18, PAKISTAN TOPICAL 1.0X15.0 11/27/2019
DP/7487 LABORATORIE UGANDA ONE + 3%W/W S.I.T.E, KARACHI EXTERNAL G TUBE
S LTD LIMITED DIPROPIONAT OINTMENTS
E + SALICYLIC
ACID
3551 NDA/MAL/H INTAS NORVIK FINTAS 5 FINASTERIDE 5MG INTAS PHARMACEUTICALS INDIA ORAL SOLID 1.0X2.0X1 7/1/2017
DP/7488 PHARMACEUT ENTERPRISES LTD .-PLOT NOS. 457, 458 ORDINARY 4.0
ICALS LTD LIMITED & 191/218P SARKHEJ- FILM- TABLET
BAVLA HIGHWAY COATED BLISTER
AHMEDABAD GUJARAT
3552 NDA/MAL/H MACLEODS NORVIK DOLUTEGR DOLUTEGRAV 50MG + MACLEODS INDIA ORAL SOLID 1.0X30.0 11/27/2019
DP/7489 PHARMACEUT ENTERPRISES AVIR, IR + 300MG + PHARMACEUTICALS LTD - ORDINARY TABLET
ICALS LTD LIMITED LAMIVUDIN LAMIVUDINE 300MG BLOCK N2, VILLAGE TABLETS BOTTLE,1.
E AND + TENOFOVIR THEDA, P.O. LODHI 0X90.0
TENOFOVIR DISOPROXIL MAJRA, TEHSIL BADDI, TABLET
DISOPROXIL FUMARATE DIST. SOLAN, HIMACHAL BOTTLE,1.
FUMARATE PRADESH 174101 0X100.0
TABLET
BOTTLE,1.
0X180.0
TABLET
BOTTLE
3553 NDA/MAL/H INTAS NORVIK INTAGRA SILDENAFIL 50MG INTAS PHARMACEUTICALS INDIA ORAL SOLID 1.0X4.0 7/1/2017
DP/7490 PHARMACEUT ENTERPRISES 50 CITRATE LTD .-PLOT NOS. 457, 458 ORDINARY TABLET
ICALS LTD LIMITED & 191/218P SARKHEJ- FILM- BLISTER
BAVLA HIGHWAY COATED
AHMEDABAD GUJARAT
3554 NDA/MAL/H DENK BENLE CONSULT CIPRO- CIPROFLOXAC 750MG ALLPHAMED PHARBIL GERMANY ORAL SOLID 1.0X10.0 7/1/2017
DP/7491 PHARMA LIMITED DENK 750 IN ARZNEIMITTEL GMBH. - ORDINARY TABLET
GMBH & CO HYDROCHLOR HILDEBRANDSTRABE 12 FILM- BLISTER
IDE 37081 GOTTINGEN COATED
TABLETS
3555 NDA/MAL/H LINCOLN ABACUS CYPRODINE CYPROHEPTA 2MG/5ML LINCOLN INDIA ORAL LIQUID 1.0X100.0 8/28/2019
DP/7492 PHARMACEUT PHARMA DINE PHARMACEUTICAL ORDINARY ML
ICALS LTD (AFRICA) HYDROCHLOR LIMITED..-LINCOLN SYRUPS BOTTLE
LIMITED IDE PHARMACEUTICALS
LIMITED, TRIMUL ESTATE,
KHATRAJ, TAL. KALOL,
DIST. GANDHINAGAR
3556 NDA/MAL/H ZIM GITTOES CEFRAZ 200 CEFIXIME 200 MG ZIM LABORATORIES INDIA ORAL SOLID 1.0X1.0X1 11/27/2019
DP/7493 LABORATORIE PHARMACEUTIC TRIHYDRATE LIMITED-B-21/22 MIDC ORDINARY 0.0
S LTD ALS LIMITED AREA KALMESHWAR FILM- TABLET
441501, DIST NAGPUR, COATED BLISTER
MAHARASHTRA TABLETS
3557 NDA/MAL/H LINCOLN ABACUS MEBEX MEBENDAZOL 100MG LINCO N INDIA ORAL SOLID 1.0X10.0X 8/28/2019
DP/7495 PHARMACEUT PHARMA E PHARMACEUTICALS ORDINARY 10.0
ICALS LTD (AFRICA) LIMITED-TRIMUL ESTATE TABLETS TABLET
LIMITED KHATRAJ KALOL GUJARAT BLISTER
INDIA
3558 NDA/MAL/H SQUARE GAMA CEFTRON CEFTRIAXONE 500 SQUARE BANGLADESH PARENTERAL 1.0X1.0 11/27/2019
DP/7496 PHARMACEUT PHARMACEUTIC 500 MG SODIUM MG/VIAL PHARMACEUTICALS ORDINARY VIAL
ICALS LTD ALS (U) LIMITED IM/IV LIMITED - DHAKA UNIT- DRY VIALS CARTON
INJECTION KALIAKOIR GAZIPUR
3559 NDA/MAL/H NAPP SURGIPHARM 125MCG + FISONS LTD (ALSO KNOWN UNITED LUNG 1.0X1.0X1 11/7/2018
DP/7497 PHARMACEUT (U) LIMITED FLUTIFORM FLUTICASONE 5MCG AS SANOFI-AVENTIS) --72 KINGDOM ADMINISTRA 20.0
ICALS LIMITED INHALER PROPIONATE LONDON ROAD, HOLMES TION METERED
+ CHAPEL CHEWE, METERED- DOSE
FORMOTEROL CHESHIRE CW4 8BE, DOSE CANNISTE
FUMARATE UNITED KINGDOM POWDER R
DIHYDRATE INHALER
3560 NDA/MAL/H AUROBINDO PHILLIPS CELDOL 100 CELECOXIB 200 MG AUROBINDO PHARMA LTD- INDIA ORAL SOLID 1.0X3.0X1 11/27/2019
DP/7498 M PHARMA PHARMACEUTIC UNIT VII ,/-SY. NO'S 411, ORDINARY 0.0
LIMITED ALS (UGANDA) 425, 434, 435 & 458, PLOT CAPSULES CAPSULE
LIMITED NO. S1 (PART), SPECIAL BLISTER
ECONOMIC ZONE
(PHARMA), APIIC, GREEN
INDUSTRIAL PARK,
POLEPALLY VILLAGE
JEDEHERLA MANDAL,
MAHABOOB NAGAR
DISTRICT-509302,
ANDHRA PRADESH
3561 NDA/MAL/H AUROBINDO PHILLIPS CELDOL 200 CELECOXIB 200 MG AUROBINDO PHARMA LTD- INDIA ORAL SOLID 1.0X3.0X1 11/27/2019
DP/7499 M PHARMA PHARMACEUTIC UNIT VII ,/-SY. NO'S 411, ORDINARY 0.0
ECONOMIC ZONE
INDUSTRIAL PARK,
POLEPALLY VILLAGE
JEDEHERLA MANDAL,
MAHABOOB NAGAR
DISTRICT-509302,
ANDHRA PRADESH
3562 NDA/MAL/H RESONANT SHREEJI DICLOZONE DICLOFENAC 50 MG + CRIS PHARMA (INDIA) INDIA ORAL SOLID 1.0X3.0X1 11/27/2019
DP/7500 PHARMACEUT PHARMACEUTIC MR POTASSIUM + 325 MG + LIMITED-E-11, UPSIDC ORDINARY 0.0
ICALS ALS LIMITED TABLETS PARACETAM 250 MG INDUSTRIAL AREA, TABLETS TABLET
OL + SELAQUI, DEHRADUN, BLISTER
CHLORZOXAZ UTTARAKHAND INDIA
ONE
3563 NDA/MAL/H GENERAL NORVIK DEXAGEN DEXAMETHAS 0.01%W/V GENERAL BANGLADESH OPHTHALMI 1.0X1.0X5 11/27/2019
DP/7501 PHARMACEUT ENTERPRISES ONE SODIUM PHARMACEUTICALS LTD C LIQUIDS .0 ML
ICALS LTD LIMITED PHOSPHATE (UNIT II)- VIAL
KAROLSURICHALA,
MOUCHAK, KALIAKOIR,
GAZIPUR
3564 NDA/MAL/H AMRING ERIS LTD CLINDABIO CLINDAMYCI 100 MG FARMAPRIM LTD-5, ROMANIA VAGINAL 1.0X1.0X3 11/27/2019
DP/7502 FARMA S.R.L X N CRINILOR STREET, SUPPOSITORI .0
PHOSPHATE PORUMBENI, CRIULENI ES PESSARY
DISTRICT, MD-4829 BLISTER
3565 NDA/MAL/H AUROBINDO PHILLIPS DUTABIT DUTASTERIDE 0.5 MG AUROBINDO PHARMA LTD- INDIA ORAL SOLID 1.0X3.0X1 11/27/2019
DP/7503 M PHARMA PHARMACEUTIC 0.5 UNIT VII ,/-SY. NO'S 411, ORDINARY 0.0
ECONOMIC ZONE
INDUSTRIAL PARK,
POLEPALLY VILLAGE
JEDEHERLA MANDAL,
MAHABOOB NAGAR
DISTRICT-509302,
ANDHRA PRADESH
3566 NDA/MAL/H ZIM ABACUS FINEVIT-D3 CHOLECALCIF 2000 IU ZIM LABORATORIES INDIA ORAL SOLID 1.0X10.0 11/27/2019
DP/7507 LABORATORIE PHARMA 2000 EROL LIMITED-B-21/22 MIDC ORDINARY TABLET
S LTD (AFRICA) (VITAMIN D3) AREA KALMESHWAR ORALLY STRIP
LIMITED 441501, DIST NAGPUR, DISINTEGRA
MAHARASHTRA TING
TABLETS
3567 NDA/MAL/H RAINBOW EUROPA FREGOUT FEBUXOSTAT 40 MG GLOBELA PHARMA INDIA ORAL SOLID 1.0X1.0X1 11/27/2019
DP/7508 LIFE SCIENCES HEALTHCARE 40 PVT.LTD.-PLOT ORDINARY 0.0
PVT.LTD. (U) LTD NO.357,G.I.D.C SACHIN FILM- TABLET
ROAD NO.3,SURAT- COATED BLISTER
394230,GUJARAT TABLETS
3568 NDA/MAL/H AMMAN WIDE IMAVIR EYE ACYCLOVIR 3% AMMAN JORDAN OPHTHALMI 1.0X5.0 G 5/29/2019
DP/7510 PHARMACEUT SPECTRUM OINTMENT PHARMACEUTICAL C TUBE
ICAL ENTERPRISES INDUSTRIES-KING OINTMENTS
ESTATE,
SAHAB, AMMAN, JORDAN
MMAN, JORDAN
3569 NDA/MAL/H RAINBOW EUROPA FREGOUT FEBUXOSTAT 80 MG GLOBELA PHARMA INDIA ORAL SOLID 1.0X1.0X1 11/27/2019
DP/7513 LIFE SCIENCES HEALTHCARE 80 PVT.LTD.-PLOT ORDINARY 0.0
3570 NDA/MAL/H İLKO İLAÇ CORE ACCESS ILFLOX 500 LEVOFLOXACI 500 MG ILKO ILAC SANAYI VE TURKEY ORAL SOLID 1.0X1.0X7 11/27/2019
DP/7514 SANAYI VE LIMITED N TICARET A.S-3.ORGANIZE ORDINARY .0 TABLET
TICARET A. Ş. HEMIHYDRAT SANAYI BOLGESI, BUYUK FILM- BLISTER
E KAYACIK MAH. KUDDISI COATED
CAD.23 SOKAKNO. 1 42050 TABLETS
SELCUKLU, KONYA
3571 NDA/MAL/H MYLAN KIMSY MEDS HEPBEST PREGABALIN 75MG + MYLAN LABORATORIES INDIA ORAL SOLID 1.0X1.0X3 11/27/2019
DP/7515 LABORATORIE LTD + 10MG LTD-PLOT NO.11, 12 & 13, ORDINARY 0.0
S LIMITED NORTRIPTYLI INDORE SPECIAL FILM- TABLET
NE (AS ECONOMIC ZONE, COATED CONTAIN
HYDROCHLOR PHARMA ZONE, PHASE II, TABLETS ER
IDE) SECTOR III, PITHAMPUR -
454775; DIST; DHAR;
MADHYA PRADESH;
3572 NDA/MAL/H İLKO İLAÇ CORE ACCESS ILFLOX 750 LEVOFLOXACI 750 MG ILKO ILAC SANAYI VE TURKEY ORAL SOLID 1.0X1.0X7 11/27/2019
DP/7516 SANAYI VE LIMITED N TICARET A.S-3.ORGANIZE ORDINARY .0 TABLET
TICARET A. Ş. HEMIHYDRAT SANAYI BOLGESI, BUYUK FILM- BLISTER
E KAYACIK MAH. KUDDISI COATED
CAD.23 SOKAKNO. 1 42050 TABLETS
SELCUKLU, KONYA
3573 NDA/MAL/H RESONANT SHREEJI LEVOCET-M LEVOCETIRIZI 5MG + CRIS PHARMA (INDIA) INDIA ORAL SOLID 1.0X3.0X1 11/27/2019
DP/7517 PHARMACEUT PHARMACEUTIC NE 10MG LIMITED-E-11, UPSIDC ORDINARY 0.0
ICALS PVT LTD ALS LIMITED DIHYDROCHL INDUSTRIAL AREA, TABLETS TABLET
ORIDE + SELAQUI, DEHRADUN, BLISTER
MONTELUKAS UTTARAKHAND INDIA
T SODIUM
3574 NDA/MAL/H RESONANT SHREEJI LEVOCET-M LEVOCETIRIZI 2.5MG / CRIS PHARMA (INDIA) INDIA ORAL LIQUID 1.0X1.0X1 11/27/2019
DP/7518 PHARMACEUT PHARMACEUTIC SUSPENSIO NE 5ML + LIMITED-E-11, UPSIDC ORDINARY 00.0 ML
ICALS ALS LIMITED N DIHYDROCHL 4MG / 5ML INDUSTRIAL AREA, SUSPENSION BOTTLE
ORIDE + SELAQUI, DEHRADUN, S
MONTELUKAS UTTARAKHAND INDIA
T SODIUM
3575 NDA/MAL/H MACLEODS NORVIK LEVOFLOXA LEVOFLOXACI 250 MG MACLEODS INDIA ORAL SOLID 1.0X1.0X5 11/27/2019
DP/7519 PHARMACEUT ENTERPRISES CIN N PHARMACEUTICALS LTD - ORDINARY .0 TABLET
ICALS LTDS LIMITED HEMIHYDRAT BLOCK N2, VILLAGE TABLETS BLISTER
LTD E THEDA, P.O. LODHI
MAJRA, TEHSIL BADDI,
DIST. SOLAN, HIMACHAL
PRADESH 174101
3576 NDA/MAL/H DAWA SUPER MEDIC LEVOXCIN LEVOFLOXACI 750 MG DAWA LIMITED -16633- KENYA ORAL SOLID 1.0X1.0X1 11/27/2019
DP/7520 LIMITED LTD N 00620, RUARAKA, BABA ORDINARY 0.0
HEMIHYDRAT DOGO ROAD, NAIROBI TABLETS TABLET
E BLISTER
3577 NDA/MAL/H HETERO LABS AIVEEN (U) LISOF LEDIPASVIR + 90MG + HETERO LABS LIMITED KENYA ORAL SOLID 1.0X1.0X2 11/27/2019
DP/7521 LTD LIMITED SOFOSBUVIR 400MG (UNIT V)-SY NO. 436,440, ORDINARY 8.0
FORMULATION SEZ, BOTTLE
POLEPALLY (V),
JEDCHERLA (M),
MAHABOOBNAGAR,
DISTRICT ANDHRA
PRADESH 509301
3578 NDA/MAL/H DENK BENLE CONSULT LEVOFLOX- LEVOFLOXACI 5MG/ML SOLUPHARM GERMANY PARENTERAL 1.0X100.0 7/1/2017
DP/7523 PHARMA LIMITED DENK 5 N PHARMAZEUTISCHE ORDINARY ML VIAL
GMB H &CO. MG/ML HEMIHYDRAT ERZEUGNISSE GMBH-- INFUSION
KG E INDUSTRIESTR. 3 34212 VIALS/BOTTL
MELSUNGEN GERMANY ES
3579 NDA/MAL/H AMMAN WIDE LOPROSTA LATANOPROS 0.005% AMMAN JORDAN OPHTHALMI 1.0X2.5 11/27/2019
DP/7524 PHARMACEUT SPECTRUM N T + TIMOLOL W/V + PHARMACEUTICALS C LIQUIDS ML VIAL
ICALS LTD ENTERPRISES MALEATE 0.5%W/V INDUSTRIES-KING
(U) LIMITED ABDULLAH II, INDUSTRIAL
ESTATE, SAHAB, AMMAN
3580 NDA/MAL/H DAWA SUPER MEDIC LORVIC LORATADINE 10 MG DAWA LIMITED-16633- KENYA ORAL SOLID 1.0X3.0X1 11/27/2019
DP/7525 LIMITED LTD 00620, RUARAKA, BABA ORDINARY 0.0
BLISTER
3581 NDA/MAL/H CORONA AIVEEN (U) MANIGRA SILDENAFIL 100 MG CORONA REMEDIES PVT. INDIA ORAL SOLID 1.0X1.0X4 11/27/2019
DP/7526 REMEDIES LIMITED 100 CITRATE LTD-VILLAGE JATOLI, POST ORDINARY .0 TABLET
PVT. LTD OFFICE- OACHGHAT, FILM- BLISTER
TEHSIL, SOLAN, DISTT. COATED
SOLAN (H.P) 173223 TABLETS
3582 NDA/MAL/H I-CARE AIVEEN (U) MANIGRA SILDENAFIL 50 MG CORONA REMEDIES PVT. INDIA ORAL SOLID 1.0X1.0X4 11/27/2019
DP/7527 PHARMA LTD LIMITED 50 CITRATE LTD-VILLAGE JATOLI, POST ORDINARY .0 TABLET
OFFICE- OACHGHAT, TABLETS BLISTER
TEHSIL, SOLAN, DISTT.
SOLAN (H.P) 173223
3583 NDA/MAL/H I-CARE AIVEEN (U) MANIGRA SILDENAFIL 100MG + CORONA REMEDIES PVT. INDIA ORAL SOLID 1.0X4.0 11/27/2019
DP/7528 PHARMA LTD LIMITED PLUS CITRATE + 60MG LTD-VILLAGE JATOLI, POST ORDINARY TABLET
DAPOXETINE OFFICE- OACHGHAT, TABLETS BLISTER
HYDROCHLOR TEHSIL, SOLAN, DISTT.
IDE SOLAN (H.P) 173223
3584 NDA/MAL/H FDC LTD AIVEEN (U) MOSI EYE MOXIFLOXACI 5 MG/ML FDC LIMITED, WALUJ .- INDIA OPHTHALMI 1.0X1.0X5 11/27/2019
DP/7529 LIMITED DROPS N PLOT NO. B-8, MIDC, C LIQUIDS .0 ML
HYDROCHLOR INDUSTRIAL AREA, WALUJ VIAL
IDE 431136 DIST
AURANGABAD
3585 NDA/MAL/H HETERO LABS AIVEEN (U) DOLUTEGR DOLUTEGRAV 50MG HETERO LABS LTD UNIT III- INDIA ORAL SOLID 1.0X1.0X3 11/7/2018
DP/7530 LTD LIMITED AVIR IR 22-110 IDA JEEDIMETIA ORDINARY 0.0
TABLETS HYDERABAD ANDHRA FILM- TABLET
50MG PRADESH , COATED CONTAIN
TABLETS ER
3586 NDA/MAL/H ABACUS ABACUS ASUNATE ARTESUNATE 60 MG LINCOLN PARENTERAL INDIA PARENTERAL 1.0X1.0 9/26/2018
DP/7533 PARENTERAL PARENTERAL 60 LIMITED- 11, TRIMUL ORDINARY VIAL
DRUGS DRUGS LIMITED ESTATE, KHATRAJ, TAL. DRY VIALS CARTON
LIMITED KALOL, + 1*5ML
DIST. GANDHINAGAR, 0.9%W/W
GUJARAT, INDIA. SODIUM
CHLORIDE
SOLUTION
AMPOULE
+ 1*1ML
5.0%W/W
SODIUM
3587 NDA/MAL/H ACME MARIE STOPES MARIPRIST MIFEPRISTON 200MG + ACME FORMULATION PVT. INDIA ORAL SOLID 1.0X1.0X1 8/28/2019
DP/7535 FORMULATIO UGANDA E+ 200MCG LTD-ROPAR ROAD, ORDINARY .0X4.0
N PVT. LTD. LIMITED MISOPROSTO NALAGARH, DIST. SOLAN, TABLETS TABLET
L HIMACHAL PRADESH BLISTER
174101
3588 NDA/MAL/H PLANET PLANET NETVAICAI BUPIVACAINE 5MG + SWISS PARENTERALS LTD- INDIA PARENTERAL 1.0X2.0X1 7/1/2017
DP/7536 PHARMACEUT PHARMACEUTIC N HYDROCHLOR 80MG /ML 809 KERALA IND ESTATE ORDINARY 0.0X4.0
ICALS ALS UGANDA IDE + GIDC NEAR BAVLA DIST AMPOULES ML
UGANDA LTD LTD DEXTROSE AHMEDABAD 382220 AMPOULE
GUJARAT INDIA ,1.0X10.0X
4.0 ML
AMPOULE
,1.0X1.0X5
.0X5.0X4.
0 ML
AMPOULE
3589 NDA/MAL/H SEV SEV COUGH CHLORPHENI 2MG/5ML SEV PHARMACEUTICALS UGANDA ORAL LIQUID 1.0X1000. 7/1/2011
DP/7539 PHARMACEUT PHARMACEUTIC LINCTUS RAMINE LIMITED-PLOT 100 ORDINARY 0 ML
ICALS LIMITED ALS LIMITED NALUKOLONGO SYRUPS JERRYCAN
,1.0X200.0
ML
BOTTLE
3590 NDA/MAL/H SEV SEV CHLORHEXI CHLORHEXIDI 4%W/V SEV PHARMACEUTICALS UGANDA TOPICAL 1.0X1000. 7/1/2012
DP/7541 PHARMACEUT PHARMACEUTIC DINE NE LIMITED-PLOT 100 EXTERNAL 0 ML
ICALS LIMITED ALS LIMITED SCRUB GLUCONATE NALUKOLONGO LIQUIDS JERRYCAN
3591 NDA/MAL/H SEV SEV GLYCERIN GLYCERINE+B 12%W/V SEV PHARMACEUTICALS UGANDA ORAL LIQUID 1.0X22.0 7/1/2013
DP/7544 PHARMACEUT PHARMACEUTIC OF BORAX ORAX LIMITED-PLOT 100 ORDINARY ML
ICALS LIMITED ALS LIMITED NALUKOLONGO LIQUIDS BOTTLE
3592 NDA/MAL/H SEV SEV HYDROGEN HYDROGEN 6%W/V SEV PHARMACEUTICALS UGANDA TOPICAL 1.0X200.0 7/1/2012
DP/7546 PHARMACEUT PHARMACEUTIC PEROXIDE PEROXIDE LIMITED-PLOT 100 EXTERNAL ML
ICALS LIMITED ALS LIMITED NALUKOLONGO LIQUIDS BOTTLE,1.
0X1.0 L
JERRYCAN
3593 NDA/MAL/H SEV SEV IODINE IODINE + 2.5%W/V+ SEV PHARMACEUTICALS UGANDA TOPICAL 1.0X22.0 7/1/2013
DP/7548 PHARMACEUT PHARMACEUTIC TINCTURE POTASSIUM 2.5%W/V LIMITED-PLOT 100 EXTERNAL ML
ICALS LIMITED ALS LIMITED IODIDE NALUKOLONGO LIQUIDS BOTTLE
3594 NDA/MAL/H SEV SEV MAGNESIU MAGNESIUM 250MG + SEV PHARMACEUTICALS UGANDA ORAL LIQUID 1.0X200.0 7/1/2010
DP/7552 PHARMACEUT PHARMACEUTIC M TRISILICATE + 250MG + LIMITED-PLOT 100 ORDINARY ML
ICALS LIMITED ALS LIMITED TRISILICATE LIGHT 250MG/5 NALUKOLONGO SUSPENSION BOTTLE
MIXTURE MAGNESIUM ML S
CARBONATE
+ SODIUM
BICARBONAT
E
3595 NDA/MAL/H SEV SEV POVIDONE POVIDONE 10%W/V SEV PHARMACEUTICALS UGANDA TOPICAL 1.0X200.0 7/1/2013
DP/7554 PHARMACEUT PHARMACEUTIC IODINE BP IODINE LIMITED-PLOT 100 EXTERNAL ML
ICALS LIMITED ALS LIMITED NALUKOLONGO LIQUIDS BOTTLE,1.
0X1000.0
ML
JERRYCAN
3596 NDA/MAL/H SEV SEV SEVASTAT CETRIMIDE + 3%W/V+0. SEV PHARMACEUTICALS UGANDA TOPICAL 1.0X1.0 L 7/1/2012
DP/7556 PHARMACEUT PHARMACEUTIC CHLORHEXIDI 3%W/V LIMITED-PLOT 100 EXTERNAL BOTTLE
ICALS LIMITED ALS LIMITED NE NALUKOLONGO LIQUIDS
3597 NDA/MAL/H SEV SEV SURGICAL METHYL 0.5%V/V SEV PHARMACEUTICALS UGANDA TOPICAL 1.0X100.0 7/1/2011
DP/7559 PHARMACEUT PHARMACEUTIC SPIRIT SALICYLATE LIMITED-PLOT 100 EXTERNAL ML
ICALS LIMITED ALS LIMITED NALUKOLONGO SPIRITS BOTTLE
3598 NDA/MAL/H SEV SEV VIOLGENT CRYSTAL 0.5%W/V SEV PHARMACEUTICALS UGANDA TOPICAL 1.0X25.0 7/1/2014
DP/7560 PHARMACEUT PHARMACEUTIC VIOLET LIMITED-PLOT 100 EXTERNAL ML
ICALS LIMITED ALS LIMITED NALUKOLONGO LIQUIDS BOTTLE
3599 NDA/MAL/H HOVID BHD UNITED NEUROVIT THIAMINE 97MG + HOVID BHD-LOT 56442, MALAYSIA ORAL SOLID 1.0X10.0X 7/1/2008
DP/7571 HEALTHCARE FILM- MONONITRA 50MG + 7.5 MILE JALAN ORDINARY 10.0
DISTRIBUTORS COATED TE + 100MG IPOH/CHEMO 31200 FILM- TABLET
LTD TABLET PYRIDOXINE CHEMOR, PERAK COATED BLISTER
HCL + MALAYSIA TABLETS
CYANOCOBAL
AMINE
3600 NDA/MAL/H OCHOA SUPER MEDIC CLEAR-T CLINDAMYCI 1.0%W/W AUROCHEM INDIA TOPICAL 1.0X20.0 11/29/2017
DP/7586 LABORATORIE LTD GEL N + LABORATORIES LTD -PLOT EXTERNAL G TUBE
S PHOSPHATE + 0.025%W/ 08 PALGHAR 401404 GELS AND
TRETINOIN W MAHARASHTRA, INDIA SOLS
3601 NDA/MAL/H DAWA SUPER MEDIC NERVILIN PREGABALIN 75 MG DAWA LIMITED-16633- KENYA ORAL SOLID 1.0X3.0X1 11/27/2019
DP/7587 LIMITED LTD 75 00620, RUARAKA, BABA ORDINARY 0.0
DOGO ROAD, NAIROBI CAPSULES CAPSULE
BLISTER
3602 NDA/MAL/H OCHOA SUPER MEDIC EXEVATE- BETAMETHAS 0.05 % AUROCHEM INDIA TOPICAL 1.0X20.0 11/29/2017
DP/7588 LABORATORIE LTD MF ONE W/W + 3.0 PHAMACEAUTICALS (1) EXTERNAL G TUBE
S OINTMENT DIPROPIONAT % W/W + LTD-58 PALGHAR TALUKA OINTMENTS
E + SALICYLIC 10.0 % INDUSTRIAL CO-
ACID + UREA W/W + 3.0 OEPERATIVE ESTATE LTD
+ LACTIC ACID % W/W + BOISAR RD PALGHAR DIST
+ SODIUM 2.0 % W/W THANE 401404 INDIA
LACTATE
SOLUTION
3603 NDA/MAL/H OCHOA SUPER MEDIC LACX LACTULOSE 10G/15ML AUROCHEM INDIA ORAL LIQUID 1.0X200.0 11/29/2017
DP/7589 LABORATORIE LTD SYRUP LABORATORIES (I) PVT LTD- ORDINARY ML
S -8 PALGHAR TALUKA SYRUPS BOTTLE,1.
INDUSTRIAL CO-OP 0X100.0
ESTATE LTD PALGHAR 401 ML
404 DIST THANE BOTTLE
3604 NDA/MAL/H KHANDELWAL SURGIPHARM ONCOMIDE CYCLOPHOSP 1000 MG KHANDELWAL INDIA PARENTERAL 1.0X50.0 11/27/2019
DP/7591 LABORATORIE (U) LIMITED HOMIDE LABORATORIES PVT. LTD-B- ORDINARY ML VIAL
S PVT 1, WAGLE INDUSTRIAL DRY VIALS
LIMITED ESTATE, THANE – 400 604
INDIA
3605 NDA/MAL/H KHANDELWAL SURGIPHARM ONCOMIDE CYCLOPHOSP 500 MG KHANDELWAL INDIA PARENTERAL 1.0X30.0 11/27/2019
DP/7592 LABORATORIE (U) LIMITED HOMIDE LABORATORIES PVT. LTD-B- ORDINARY ML VIAL
S PVT 1, WAGLE INDUSTRIAL DRY VIALS
LIMITED ESTATE, THANE – 400 604
INDIA
3606 NDA/MAL/H AMRING ERIS LTD PARACETA PARACETAM 10 MG/ML CLARIS INJECTABLES INDIA PARENTERAL 1.0X1.0X1 11/27/2019
DP/7593 PHARMA MOL OL LIMITED-VASANA- ORDINARY 00.0 ML
AMRING CHACHARWADI, TAL- INFUSION BOTTLE
SANAND-382 213, INDIA VIALS/BOTTL
ES
3607 NDA/MAL/H SANDOZ SURGIPHARM HYDROCHL HYDROCHLOR 25MG SALUTAS PHARMA GMBH- GERMANY ORAL SOLID 1.0X4.0X2 7/1/2017
DP/7594 GMBH, (U) LIMITED OROTHIAZI OTHIAZIDE OTTO-VON-GUERICKE- ORDINARY 5.0
KUNDL DE 25MG ALLEE 1, 39179 BARLEBEN, TABLETS TABLET
TABLETS BLISTER
3608 NDA/MAL/H AMMAN WIDE LOPROST LATANOPROS 0.005% AMMAN JORDAN OPHTHALMI 1.0X2.5 11/27/2019
DP/7595 PHARMACEUT SPECTRUM T W/V PHARMACEUTICALS C VIALS ML VIAL
ICALS LTD ENTERPRISES INDUSTRIES-KING
(U) LIMITED ABDULLAH II, INDUSTRIAL
ESTATE, SAHAB, AMMAN
3609 NDA/MAL/H INTERNATION AIVEEN (U) LTD - PEGASET PREGABALIN 150 MG CORONA REMEDIES PVT INDIA ORAL SOLID 1.0X4.0X7 11/27/2019
DP/7596 AL WILSON ROAD 150 LTD..-VILLAGE JATOLI, ORDINARY .0
ORGANIZATIO POST OFFICE - OACHGHAT, CAPSULES CAPSULE
N FOR TEHSIL SOLAN, DIST. BLISTER
MIGRATION SOLAN
HIMACHAL PRADESH
3610 NDA/MAL/H STEDMAN VEERAM RABEFLUX- RABEPRAZOL 20MG + STEDMAN INDIA ORAL SOLID 1.0X10.0X 11/27/2019
DP/7598 PHARMACEUT HEALTHCARE DSR E SODIUM + 30MG PHARMACEUTICALS PVT. ORDINARY 10.0
ICALS PVT. (U) LIMITED DOMPERIDO LTD.-C-4, SIDCO CAPSULES CAPSULE
LTD NE PHARMACEUTICALS BLISTER
COMPLEX, ALATHUR,
THIRUPORUR- 603 110,
TAMIL NADU INDIA
3611 NDA/MAL/H AMRING ERIS LTD RITUXIMAB RITUXIMAB 100 MG/10 SINERGIUM BIOTECH SA- ARGENTINA PARENTERAL 1.0X2.0X1 11/27/2019
DP/7599 FARMA S.R.L AMRING AMRING ML RUTA PANAMERICANA ORDINARY 0.0 ML
KM 38.7 GARIN BUENOS VIALS VIAL
AIRES, MABXIENCE S.A.U-
CARLOS VILLAGE 5148
MUNRO, BUENOS AIRES
B16054XL
3612 NDA/MAL/H RESONANT SHREEJI NO COLD PARACTAMOL 125MG + CRIS PHARMA (INDIA) INDIA ORAL LIQUID 1.0X1.0X1 11/27/2019
DP/7600 PHARMACEUT PHARMACEUTIC SYRUP + PHENYL 5MG + LIMITED-E-11, UPSIDC ORDINARY 00.0 ML
ICALS PVT LTD ALS LIMITED HYDROCHLOR 1MG + INDUSTRIAL AREA, LIQUIDS BOTTLE
IDE + 60MG / SELAQUI, DEHRADUN,
CHLORPHENA 5ML UTTARAKHAND INDIA
MINE
MALEATE +
SODIUM
CITRATE
3613 NDA/MAL/H AMRING ERIS LTD RITUXIMAB RITUXIMAB 500 MG/50 SINERGIUM BIOTECH SA- ARGENTINA PARENTERAL 1.0X1.0X5 11/27/2019
DP/7601 FARMA S.R.L AMRING ML RUTA PANAMERICANA ORDINARY 0.0 ML
KM 38.7 GARIN BUENOS VIALS VIAL
AIRES, MABXIENCE S.A.U-
CARLOS VILLAGE 5148
MUNRO, BUENOS AIRES
B16054XL
3614 NDA/MAL/H RAINBOW EUROPA ROSICARD ROSUVASTATI 10 MG GLOBELA PHARMA INDIA ORAL SOLID 1.0X3.0X1 11/27/2019
DP/7602 LIFE SCIENCES HEALTHCARE 10 N CALCIUM PVT.LTD.-PLOT ORDINARY 0.0
3615 NDA/MAL/H RAINBOW EUROPA ROSICARD 5 ROSUVASTATI 5 MG GLOBELA PHARMA INDIA ORAL SOLID 1.0X3.0X1 11/27/2019
DP/7603 LIFE SCIENCES HEALTHCARE N CALCIUM PVT.LTD.-PLOT ORDINARY 0.0
3616 NDA/MAL/H INVENTIA EUROPA SEGABIN M PREGABALIN 150MG + INVENTIA HEALTHCARE INDIA ORAL SOLID 1.0X3.0X1 11/27/2019
DP/7604 HEALTHCARE HEALTHCARE 150 + 1500MCG PVT LTD -F1-F1/1 RETARD 0.0
PVT LTD (U) LTD METHYLCOBA ADDITIONAL MIDC TABLETS TABLET
LAMIN AMBERNATH (E) DIST. BLISTER
THANE
3617 NDA/MAL/H GUFIC EUROPA STRIPOLE PANTOPRAZO 40 MG GUFIC LIFESCIENCES INDIA PARENTERAL 1.0X1.0 11/27/2019
DP/7605 LIFESCIENCES HEALTHCARE LE SODIUM PRIVATE LIMITED- SURVEY ORDINARY VIAL
PRIVATE LTD (U) LTD SESQUIHYDR NO. 171, N.H. NO-8, NEAR DRY VIALS CARTON
ATE FRID, KABILPORE, CITY- + 1*1OML
NAVSARI-396424, DIST. SODIUM
NAVSARI, GUJARAT STATE, CHLORIDE
INDIA SOLUTION
0.9% W/V
3618 NDA/MAL/H FDC LTD AIVEEN (U) TEARMAX CARMELLOSE 5MG/ML FDC LIMITED, WALUJ .- INDIA OPHTHALMI 1.0X1.0X1 11/27/2019
DP/7607 LIMITED EYE DROPS SODIUM PLOT NO. B-8, MIDC, C LIQUIDS 0.0 ML
INDUSTRIAL AREA, WALUJ VIAL
431136 DIST
AURANGABAD
3619 NDA/MAL/H RAINBOW EUROPA TELMICARD TELMISARTA 40 MG GLOBELA PHARMA INDIA ORAL SOLID 1.0X3.0X1 11/27/2019
DP/7608 LIFE SCIENCES HEALTHCARE 40 N PVT.LTD.-PLOT ORDINARY 0.0
PVT LTD (U) LTD NO.357,G.I.D.C SACHIN TABLETS TABLET
394230,GUJARAT
3620 NDA/MAL/H RAINBOW EUROPA TELMICARD TELMISARTA 80 MG GLOBELA PHARMA INDIA ORAL SOLID 1.0X3.0X1 11/27/2019
DP/7609 LIFE SCIENCES HEALTHCARE 80 N PVT.LTD.-PLOT ORDINARY 0.0
PVT LTD (U) LTD NO.357,G.I.D.C SACHIN TABLETS TABLET
394230,GUJARAT
3621 NDA/MAL/H ATCO HARLEYS TERBIDERM TERBINAFINE 250 MG ATCO LABS LTD,-B-18, PAKISTAN ORAL SOLID 1.0X1.0X1 11/27/2019
DP/7610 LABORATORIE UGANDA FORTE HYDROCHLOR S.I.T.E, KARACHI ORDINARY 0.0
S LTD LIMITED IDE TABLETS TABLET
BLISTER
3622 NDA/MAL/H FERRING MACNAUGHTON PABAL CARBETOCIN 100MCG/ FERRING GMBH.-11, GERMANY PARENTERAL 1.0X5.0X1 7/1/2017
DP/7611 GMBH LIMITED ML WITTLAND ORDINARY .0 ML
VIALS VIAL
3623 NDA/MAL/H PLANET PLANET TOPCLIN CLINDAMYCI 1 %W/W KREMOINT PHARMA PVT INDIA TOPICAL 1.0X25.0 11/27/2019
DP/7614 PHARMACEUT PHARMACEUTIC N LTD PLANT II-B-8, EXTERNAL G TUBE
ICALS ALS UGANDA PHOSPHATE ADDITIONAL AMBERNATH EMULSION
UGANDA LTD LTD MIDC, AMBERNATH (EAST) GELS
DIST. THANE 421506
3624 NDA/MAL/H I CARE AIVEEN (U) AIVCLAV- AMOXICILLIN 500MG + MEDICEF PHARMA-NO. 28, INDIA ORAL SOLID 1.0X2.0X1 11/26/2019
DP/7615 PHARMA LIMITED 625 + 125MG PHASE 1, EPIP, ORDINARY 0.0
LIMITED CLAVULANIC JHARRMAJRI, BADDI, DIST TABLETS TABLET
ACID SOLAN (HP) BLISTER,1.
0X2.0X7.0
TABLET
BLISTER
3625 NDA/MAL/H INCEPTA ECHO XIMEPROX CEFPODOXIM 100MG/5 INCEPTA BANGLADESH ORAL LIQUID 1.0X15.0 11/26/2019
DP/7616 PHARMACUTI PHARMACY (U) E PROXETIL ML PHARMACEUTICALS LTD .- ORDINARY ML
CALS LIMITED LIMITED DEWAN IDRIS ROAD, BARA DRY BOTTLE
RANGAMATIA, ZIRABO, SUSPENSION
SAVAR-DHAKA S/SYRUPS/D
ROPS
3626 NDA/MAL/H CIPLA CIPLA QUALITY EFAVIRENZ, EFAVIRENZ + 600 MG + CIPLA QUALITY UGANDA ORAL SOLID 1.0X1.0X3 3/28/2018
DP/7617 QUALITY CHEMICAL LAMIVUDIN LAMIVUDINE 300 MG + CHEMICALS INDUSTRIES ORDINARY 0.0
CHEMICAL INDUSTRIES E& + TENOFOVIR 300 MG LIMITED--PLOT 1-7 1ST FILM- TABLET
INDUSTRIES LIMITED TENOFOVIR DISOPROXIL RING ROAD, LUZIRA COATED BOTTLE
LIMITED DISOPROXIL FUMARATE INDUSTRIAL PARK P O BOX TABLETS
FUMARATE 34871, KAMPALA,
TABLETS UGANDA
600
MG/300
MG /300
MG
3627 NDA/MAL/H INCEPTA ECHO XIMEPROX CEFPODOXIM 200MG INCEPTA BANGLADESH ORAL SOLID 1.0X3.0X4 11/26/2019
DP/7618 PHARMACUTI PHARMACY (U) 200 E PROXETIL PHARMACEUTICALS LTD .- ORDINARY .0 TABLET
CALS LIMITED LIMITED DEWAN IDRIS ROAD, BARA TABLETS BLISTER
RANGAMATIA, ZIRABO,
SAVAR-DHAKA
3628 NDA/MAL/H INCEPTA ECHO NOMOPIL 2 REPAGLINIDE 2MG INCEPTA BANGLADESH ORAL SOLID 1.0X5.0X1 11/26/2019
DP/7629 PHARMACUTI PHARMACY (U) PHARMACEUTICALS LTD .- ORDINARY 0.0
CALS LIMITED LIMITED DEWAN IDRIS ROAD, BARA TABLETS TABLET
RANGAMATIA, ZIRABO, BLISTER
SAVAR-DHAKA
3629 NDA/MAL/H ADWIA WIDE AMADOL TRAMADOL 100MG ADWIA CO. S.A.E-10TH OF EGYPT ORAL SOLID 1.0X1.0X1 7/25/2018
DP/7631 SPECTRUM 100MG SR HYDROCHLOR RAMADAN CITY, RETARD 0.0
ENTERPRISES TABLET IDE INDUSTRIAL AREA A2, TABLETS TABLET
(U) LIMITED EGYPT BLISTER
3630 NDA/MAL/H SANDOZ SURGIPHARM BISOPROLO BISOPROLOL 2.5MG LEK S.A.-16 PODLIPIE STR. POLAND ORAL SOLID 1.0X2.0X1 7/1/2017
DP/7632 GMBH, (U) LIMITED L 2.5 MG FUMARATE 95-010 STRYKOW ORDINARY 5.0
KUNDL FILM- FILM- TABLET
COATED COATED BLISTER
TABLETS TABLETS
3631 NDA/MAL/H SANDOZ SURGIPHARM BISOPROLO BISOPROLOL 5 MG LEK S.A.-16 PODLIPIE STR. POLAND ORAL SOLID 1.0X4.0X2 7/1/2017
DP/7634 GMBH, (U) LIMITED L 95-010 STRYKOW ORDINARY 5.0
KUNDL FILM- TABLET
COATED BLISTER
TABLETS
3632 NDA/MAL/H SANDOZ SURGIPHARM BISOPROLO BISOPROLOL 10MG LEK S.A-95 - 010 POLAND ORAL SOLID 1.0X4.0X2 7/1/2017
DP/7635 GMBH, (U) LIMITED L 10MG FUMARATE STRYKÓW, PODLIPIE 16, ORDINARY 5.0
KUNDL FILM- POLAND SALUTAS FILM- TABLET
COATED PHARMA GMBH-OTTO- COATED BLISTER
TABLETS VON-GUERICKE-ALLEE TABLETS
3633 NDA/MAL/H SAKAR HARLEYS PARABUFE IBUPROFEN + (100MG + SAKAR HEALTHCARE INDIA ORAL LIQUID 1.0X60.0 5/30/2018
DP/7649 HEALTHCARE UGANDA N PARACETAM 162.5MG)/ LIMITED-BLOCK NO. 10-13, ORDINARY ML
PVT LTD LIMITED SUSPENSIO OL 5ML SARKHEJ-BAVLA SUSPENSION BOTTLE,1.
N HIGHWAY, S 0X100.0
VILL: CHANGODAR, DIST: ML
AHMEDABAD-382213, BOTTLE
GUJARAT – INDIA.
3634 NDA/MAL/H A.MENARINI PHILLIPS SPASMOME OTILONIUM 40MG A.MENARINI ITALY ORAL SOLID 1.0X2.0X1 7/1/2017
DP/7656 INDUSTRIE PHARMACEUTIC N BROMIDE MANUFACTURING ORDINARY 5.0
FARMACEUTI ALS (UGANDA) LOGISTICS AND SERVICES FILM- TABLET
CHE RIUNITE LIMITED S.R.L-VIA CAMPO DI PILE, COATED BLISTER
L’AQUILA (AQ), ITALY TABLETS
3635 NDA/MAL/H CIPLA CIPLA QUALITY ZENTAIR ENTECAVIR 1.0MG CIPLA QUALITY CHEMICAL UGANDA ORAL SOLID 1.0X10.0 7/1/2017
DP/7663 QUALITY CHEMICAL MONOHYDRA INDUSTRIES LIMITED-PLOT ORDINARY TABLET
CHEMICAL INDUSTRIES TE 1-7, LUZIRA FILM- BLISTER
INDUSTRIES LIMITED COATED
LIMITED TABLETS
3636 NDA/MAL/H SAGA SUPER MEDIC ZIMYCIN AZITHROMYCI 500MG SAGA LABORATORIES-- INDIA ORAL SOLID 1.0X3.0 7/1/2017
DP/7667 LABORATORIE LTD 500 N DIHYDRATE SURVEY NO.198/2 & 198/3 ORDINARY TABLET
S CHACHRAWADI VASNA, FILM- BLISTER
TAL; SANAND COATED
AHMEDABAD 382210. TABLETS
3637 NDA/MAL/H IPCA MEDVIN DICHLOR- CHLORTHALID 25MG IPCA LABORATORIES INDIA ORAL SOLID 1.0X3.0X1 7/1/2017
DP/7671 LABORATORIE PHARMA 25 ONE LTD,PLOT NO. T-139 - ORDINARY 0.0
S LTD LIMITED SEJAVTA, RATLAM-457 002 TABLETS TABLET
(M.P.) INDIA BLISTER
3638 NDA/MAL/H NOVARTIS SURGIPHARM VALSARTAN VALSARTAN 80MG NOVARTIS PHARMA STEIN SPAIN ORAL SOLID 1.0X2.0X1 7/1/2017
DP/7673 PHARMA (U) LIMITED AG.-SCHAFF HAUSER ORDINARY 4.0
SERVICES INC STRASSE 4332, STEIN - FILM- TABLET
SWITZERLAND NOVARTIS COATED BLISTER
FARMACEUTICA SA- TABLETS
RONDA DE SANTA
MARIA,158, E-08210
BARBERA DEL VALLES
BARCELONA SPAIN
3639 NDA/MAL/H ABACUS ABACUS ABLEVOX LEVOFLOXACI 5G/L ABACUS PARENTERAL UGANDA PARENTERAL 1.0X100.0 7/1/2017
DP/7674 PARENTERAL PARENTERAL N DRUGS LIMITED-BLOCK ORDINARY ML
DRUGS DRUGS LIMITED HEMIHYDRAT 191, PLOT NO. 114, INFUSION BOTTLE
LIMITED E GWAWANYA KINGA AND VIALS/BOTTL
KAPEKA MUKONO ES
DISTRICT, UGANDA.
3640 NDA/MAL/H NOVARTIS SURGIPHARM VALSARTAN VALSARTAN 160MG NOVARTIS PHARMA STEIN SPAIN ORAL SOLID 1.0X2.0X1 7/1/2017
DP/7675 PHARMA (U) LIMITED AG.-SCHAFF HAUSER ORDINARY 4.0
SERVICES INC STRASSE 4332, STEIN - FILM- TABLET
SWITZERLAND NOVARTIS COATED BLISTER
FARMACEUTICA SA- TABLETS
RONDA DE SANTA
MARIA,158, E-08210
BARBERA DEL VALLES
BARCELONA SPAIN
3641 NDA/MAL/H GLOBAL NAPI WIDE DELAREX DESLORATADI 5MG GLOBAL NAPI EGYPT ORAL SOLID 1.0X2.0X1 7/1/2017
DP/7683 PHARMACEUT SPECTRUM NE PHARMACEUTICALS -2ND ORDINARY 0.0
ICALS ENTERPRISES INDUSTRIAL ZONE, NO.40, FILM- TABLET
(U) LIMITED ST. NO 18, 6TH OCTOBER, COATED BLISTER
GIZA, TABLETS
3642 NDA/MAL/H EGYPTIAN WIDE OPTIGENT GENTAMICIN 0.3W/V EGYPTIAN EGYPT OPHTHALMI 1.0X5.0 7/1/2017
DP/7686 INTERNATION SPECTRUM EYE/EAR SULPHATE INTERNATIONAL C DROPS ML
AL ENTERPRISES DROPS PHARMACEUTICAL BOTTLE
COMPANY
3643 NDA/MAL/H MERCK (PTY) UNITED GLUCOPHA METFORMIN 850MG NKUNZI SOUTH ORAL SOLID 1.0X300.0 7/1/2017
DP/7688 LTD HEALTHCARE GE 850MG HYDROCHLOR PHARMACEUTICALS-259 AFRICA ORDINARY TABLET
DISTRIBUTORS TABLET IDE DAVIDSON ROAD, FILM- CONTAIN
LTD WADEVILLEGERMISTON, COATED ER,1.0X60
1428 SOUTH AFRICA TABLETS .0 TABLET
CONTAIN
ER,1.0X4.
0X15.0
TABLET
BLISTER
3644 NDA/MAL/H UNOSOURCE ESCORTS CORTUM CEFUROXIME 500MG AKUMS DRUGS & INDIA ORAL SOLID 1.0X10.0X 7/1/2017
DP/7695 PHARMA LTD. PHARMACEUTIC 500 AXETIL PHARMACEUTICALS LTD.- ORDINARY 10.0
ALS LIMITED PLANT III, PLOT NO. 19, FILM- TABLET
20, 21, SECTOR 6-A, IIE, COATED BLISTER
SIDCUL, RANIPUR, TABLETS
DISTRICT: UTTARAKHAND
INDIA
3645 NDA/MAL/H MYLAN KIMSY MEDS FLUCONAZ FLUCONAZOL 200 MG MYLAN LABORATORIES INDIA ORAL SOLID 1.0X30.0 7/1/2017
DP/7701 LABORATORIE LTD OLE E LIMITED, √-PLOT NO. H-12 ORDINARY TABLET
S LIMITED TABLETS & H-13, MIDC, WALUJ TABLETS BOTTLE
200 MG INDUSTRIAL AREA
AURANGABBAD- 431136
MAHARASTRA STATE,
INDIA. √
3646 NDA/MAL/H INCEPTA ECHO OTICLOR CEFACLOR 125MG/5 INCEPTA BANGLADESH ORAL LIQUID 1.0X100.0 11/29/2019
DP/7705 PHARMACUTI PHARMACY (U) MONOHYDRA ML PHARMACEUTICALS LTD .- ORDINARY ML
CALS LIMITED LIMITED TE DEWAN IDRIS ROAD, BARA DRY BOTTLE
RANGAMATIA, ZIRABO, SUSPENSION
SAVAR-DHAKA S/SYRUPS/D
ROPS
3647 NDA/MAL/H CACHET ASTRA PHARMA CACEF 200 CEFPODOXIM 200MG ALKEM LABORATORIES INDIA ORAL SOLID 1.0X6.0 7/1/2017
DP/7706 PHARMACEUT (U) LIMITED E PROXETIL LIMITED -VILLAGE- THANA ORDINARY TABLET
ICALS PVT BADDI, YEH TABLETS BLISTER,1.
LIMITED NALAGAR, DISTRICT 0X10.0
SOLAN, HIMACHAL TABLET
PRADESH BLISTER
INDIA
3648 NDA/MAL/H LEBEN ANDYCO LAMPYKLO AMPICILLIN 250MG+25 LEBEN LABORATORIES INDIA ORAL SOLID 1.0X10.0X 7/1/2017
DP/7708 LABORATORIE PHARMACY X CAPSULES TRIHYDRATE+ 0MG PVT. LTD-PLOT NO. L-4, ORDINARY 10.0
S PVT.LTD (UGANDA) LTD CLOXACILLIN PHASE-III, MIDC, CAPSULES CAPSULE
SODIUM AKOLA– 444 104 (MS). BLISTER
3649 NDA/MAL/H NITIN HEALTHCARE DEXAMETH DEXAMETHAS 8MG/2ML NITIN LIFESCIENCES LTD-- INDIA PARENTERAL 1.0X50.0X 7/1/2017
DP/7709 LIFESCIENCES LTD. ASONE ONE SODIUM RAMPUR ROAD PAONTA ORDINARY 2.0 ML
LTD SODIUM PHOSPHATE SAHIB DIST. SIRMOUR AMPOULES AMPOULE
PHOSPHAT (H.P) 173 025
E
3650 NDA/MAL/H HOVID BHD UNITED DIABETMIN METFORMIN 850MG HOVID BHD (IPOH SITE)- MALAYSIA ORAL SOLID 1.0X10.0X 7/1/2017
DP/7711 HEALTHCARE 850 MG HYDROCHLOR 121 ,JALAN TUNKU ABDUL ORDINARY 10.0
DISTRIBUTORS IDE RAHMAN , 30010 IPOH , TABLETS TABLET
LTD PERAK , MALAYSIA BLISTER
3651 NDA/MAL/H INCEPTA ECHO MEBASTIN MEBHYDROLI 500MG INCEPTA BANGLADESH ORAL SOLID 1.0X10.0X 11/29/2019
DP/7712 PHARMACUTI PHARMACY (U) N PHARMACEUTICALS LTD .- ORDINARY 10.0
SAVAR-DHAKA
3652 NDA/MAL/H INCEPTA ECHO TIMOZIN TIEMONIUM 50MG INCEPTA BANGLADESH ORAL SOLID 1.0X10.0X 11/29/2019
DP/7713 PHARMACUTI PHARMACY (U) METHYLSULF PHARMACEUTICALS LTD .- ORDINARY 5.0
CALS LIMITED LIMITED ATE DEWAN IDRIS ROAD, BARA TABLETS TABLET
SAVAR-DHAKA
3653 NDA/MAL/H CORE ACCESS CORE ACCESS ALRINAST DESLORATIDI 2.5 MG / 5 İLKO İLAÇ SANAYI VE TURKEY ORAL LIQUID 1.0X150.0 11/29/2017
DP/7716 LIMITED LTD 2.5 MG / 5 NE ML TICARET A. Ş-3. ORGANIZE ORDINARY ML
ML SYRUP SANAYI BÖLGESI KUDDUSI SYRUPS BOTTLE
CAD. 23. SOK. NO:1
SELÇUKLU / KONYA
3654 NDA/MAL/H SANOFI- SURGIPHARM MAALOX ALUMINIUM 175MG + NATTERMAN & CIE , GERMANY ORAL LIQUID 1.0X250.0 7/1/2017
DP/7721 AVENTIS (U) LIMITED LEMON HYDROXIDE + 200MG + GMBH ORDINARY ML
KENYA FLAVORING MAGNESIUM 25MG/ NATTERMANNALLEE 1 - SUSPENSION BOTTLE,1.
HYDROXIDE + 5ML ,50829 COLOGNE , S 0X355.0
SIMETHICONE GERMANY ML
BOTTLE
3655 NDA/MAL/H SANOFI- SURGIPHARM MAALOX ALUMINIUM 175MG + NATTERMAN & CIE , GERMANY ORAL LIQUID 1.0X355.0 7/1/2017
DP/7722 AVENTIS (U) LIMITED MINT HYDROXIDE + 200MG/ GMBH ORDINARY ML
KENYA FLAVORING MAGNESIUM 5ML NATTERMANNALLEE 1 - SUSPENSION BOTTLE,1.
HYDROXIDE ,50829 COLOGNE , S 0X250.0
GERMANY ML
BOTTLE
3656 NDA/MAL/H FERRING MACNAUGHTON MENOPUR HIGHLY 75 IU + 75 FERRING (PTY) LTD- GERMANY PARENTERAL 10.0X4.0 7/1/2017
DP/7724 GMBH LIMITED PURIFIED IU/ 4ML WITTLAND II 24146 KIEL ORDINARY ML VIAL
MENOTROPHI VIAL DRY VIALS 10*1ML
N[ CLEAR
CORRESPOND COLOURL
ING TO ESS GLASS
FOLLICLE AMPOULE
STIMULATING S
HORMONE CONTAINI
ACTIVITY NG
(FSH) 75 IU + 9.0MG/M
LUTEINISING L OF NACL
3657 NDA/MAL/H AMANTA PHARMA VILLE RINGER COMPOUND MULTI- MARCK BIOSCIENCES INDIA ORAL LIQUID 1.0X500.0 7/1/2017
DP/7727 HEALTHCARE LIMITED LACTATE SODIUM INGREDIEN LIMITED. .-PLOT 876, NH ORDINARY ML
LTD LACTATE T NO. 8, HARIYALA, KHEDA- DRY BOTTLE
387411, GUJARAT SUSPENSION
S/SYRUPS/D
ROPS
3658 NDA/MAL/H NORVATIS SURGIPHARM LINEX LACTOBACILL 1.2 * 10 TO LEK PHARMACEUTICALS- SLOVENIA ORAL SOLID 1.0X2.0X8 7/1/2017
DP/7728 PHARMA (U) LIMITED US POWER 7 D.D VEROVŠKOVA 57, ORDINARY .0
SERVICES INC. ACIDOPHILUS COLONY 1526 LJUBLJANA CAPSULES CAPSULE
+ FORMING SLOVENIA BLISTER
BIFIDOBACTE UNITS OF
RIUM VIABLE
INFANTIS + LACTIC
ENTEROCOCC ACID
US FAECIUM BACTERIA
SPECIES
3659 NDA/MAL/H AJANTA ABACUS IBUMOL PARACETAM 325MG + AJANTA PHARMA LIMITED INDIA ORAL SOLID 1.0X3.0X1 7/1/2017
DP/7735 PHARMA PHARMA 400 OL + 400MG PAITHAN- ORDINARY 0.0
LIMITED (AFRICA) IBUPROFEN MANUFACTURING UNIT B- TABLETS TABLET
LIMITED 4/5/6 MIDC PAITHAN BLISTER
DISTRICT AURANGABAD
431 148 MAHARASTRA
STATE INDIA
3660 NDA/MAL/H UNOSOURCE ABACUS METHICOW METHYLCOBA 1500 AKUMS DRUGS & INDIA PARENTERAL 1.0X5.0X1 7/1/2017
DP/7740 PHARMA LTD. PHARMA EL 1500 LAMIN MCG/ML PHARMACEUTICALS LTD.- ORDINARY .0 ML
(AFRICA) 2, 3, 4, & 5, SEC-6B, I.I.E., AMPOULES AMPOULE
LIMITED SIDCUL, RANIPUR,
HARIDWAR-249403 (INDIA
3661 NDA/MAL/H UNOSOURCE ESCORTS THERMOD PARACETAM 1.0%W/V AKUMS DRUGS & INDIA PARENTERAL 1.0X100.0 7/1/2017
DP/7747 PHARMA LTD. PHARMACEUTIC OL OL PHARMACEUTICALS LTD.- ORDINARY ML
ALS LIMITED 2, 3, 4, & 5, SEC-6B, I.I.E., INFUSION BOTTLE
SIDCUL, RANIPUR, VIALS/BOTTL
HARIDWAR-249403 (INDIA ES
3662 NDA/MAL/H UNOSOURCE ABACUS UNODEX BROMHEXINE 8MG + AKUMS DRUGS & INDIA ORAL LIQUID 1.0X100.0 7/1/2017
DP/7751 PHARMA LTD. PHARMA COUGH HYDROCHLOR 10MG + PHARMACEUTICALS LTD- ORDINARY ML
(AFRICA) SYRUP IDE + 100MG PLANT II-PLOT NO.22, SYRUPS BOTTLE
LIMITED DEXTROMET SECTOR 6-A, IIE, SIDCUL,
HORPHAN RANIPUR,DISTRICT:
HYDROBROM HARIDWAR 249 403, INDIA
IDE +
AMMONIUM
CHLORIDE
3663 NDA/MAL/H ABACUS ABACUS OZACE MD OLANZAPINE 10MG PSYCHOTROPICS INDIA INDIA ORAL SOLID 1.0X10.0X 7/1/2017
DP/7760 PHARMA (A) PHARMA 10 LTD-PLOT NO. 46 & 49 ORDINARY 10.0
LTD. (AFRICA) SECTOR -6A IIE SIDCUL SOLUBLE TABLET
LIMITED RANIPUR HARIDWAR TABLETS BLISTER
249403 UTTARAKHAND
PSYCHOTROPICS INDIA
LTD PLOT--NO. 46 & 49
SECTOR -6A IIE SIDCUL
RANIPUR HARIDWAR
249403 UTTARAKHAND
3664 NDA/MAL/H DAFRA LABOREX LORATOL LORATADINE 5MG/5ML NOBEL ILAC DUZCE- TURKEY ORAL LIQUID 1.0X100.0 7/1/2017
DP/7784 PHARMA UGANDA SANAYIINVE TICARET A.S ORDINARY ML
GMBH LIMITED SANCAKLAR 81100 DUZCE SUSPENSION BOTTLE
S
3665 NDA/MAL/H MICRO LABS PHILLIPS MELMET- METFORMIN 1000MG MICRO LABS LTD--NO 92, INDIA ORAL SOLID 1.0X3.0X1 7/1/2009
DP/7903 LIMITED PHARMACEUTIC 1000SR HYDROCHLOR SIPCOT, HOSUR-635 126,, RETARD 0.0
ALS (UGANDA) IDE TAMIL NADU, INDIA COATED TABLET
LIMITED TABLETS BLISTER
3666 NDA/MAL/H NABIQASIM JEET ACEFYL ACEFYLINE 45MG NABIQASIM INDUSTRIES PAKISTAN ORAL LIQUID 1.0X120.0 7/1/2016
DP/7905 INDUSTRIES PHARMACEUTIC PIPERAZINE + +8MG (PVT) LIMITED-17/24, ORDINARY ML
(PVT) LTD. ALS LIMITED DIPHENHYDR KORANGI INDUSTRIAL SYRUPS BOTTLE
AMINE AREA, KARACHI, PAKISTAN
HYDROCHLOR
IDE
3667 NDA/MAL/H AXA VITACARE IVMOL PARACETAM 10MG/ML AXA PARENTERAL LIMITED- INDIA PARENTERAL 1.0X100.0 7/1/2016
DP/7906 PARENTERALS LIMITED OL PLOT NO.936,937&939, ORDINARY ML
3668 NDA/MAL/H BHARAT ABACUS HUCOG CHORIONIC 5000 I.U/ BHARAT SERUMS & INDIA PARENTERAL 1.0X5000. 7/1/2017
DP/7907 SERUMS AND PHARMA 5000 HP GONADOTRO VIAL VACCINES LIMITED -PLOT ORDINARY 0 I.U VIAL
VACCINES LTD (AFRICA) PHIN NO. K-27, ADDITIONAL DRY VIALS + 1*1ML
LIMITED MIDC, 0.9%W/V
AMBERNATH (E) NACL
MAHARASHTRA STATE AMBER
421501 GLASS
AMPOULE
3669 NDA/MAL/H SANOFI- SURGIPHARM LANTUS INSULIN 100 SANOFI-AVENTIS GERMANY PARENTERAL 1.0X10.0 7/1/2017
DP/7909 AVENTIS (U) LIMITED GLARGINE UNITS/ML DEUTSCHLAND GMBH- ORDINARY S ML VIAL
KENYA INDUSTRIEPARK HOECHST, C VIALS
BRUNINGSTRASSEN,
BUILDING D-65926
FRANKFURT AM MAIN,
GERMANY
3670 NDA/MAL/H SANOFI- SURGIPHARM LANTUS INSULIN 100 SANOFI-AVENTIS GERMANY PARENTERAL 1.0X5.0X3 7/1/2017
DP/7910 AVENTIS (U) LIMITED GLARGINE UNITS/ML DEUTSCHLAND GMBH- ORDINARY .0 ML
KENYA INDUSTRIEPARK HOECHST, CARTRIDGES CARTRIDG
BRUNINGSTRASSEN, E
BUILDING D-65926
FRANKFURT AM MAIN,
GERMANY
3671 NDA/MAL/H SANOFI- SURGIPHARM LANTUS INSULIN 100 SANOFI-AVENTIS GERMANY PARENTERAL 1.0X5.0X3 7/1/2017
DP/7911 AVENTIS (U) LIMITED SOLOSTAR GLARGINE UNITS/ML DEUTSCHLAND GMBH- ORDINARY .0 ML
KENYA INDUSTRIEPARK HOECHST, PRE-FILLED PREFILLED
BRUNINGSTRASSEN, PENS PEN
BUILDING D-65926
FRANKFURT AM MAIN,
GERMANY
3672 NDA/MAL/H UNOSOURCE ABACUS GLIMEWEL GLIMEPIRIDE 1MG + AKUMS DRUGS & INDIA ORAL SOLID 1.0X10.0X 7/1/2017
DP/7912 PHARMA LTD. PHARMA M-1 + 500MG PHARMACEUTICALS LTD -- ORDINARY 10.0
(AFRICA) METFORMIN 19,20,21, SECTOR 6A, I.I.E, LAYERED TABLET
LIMITED HYDROCHLOR SIDCUL, RANIPUR, TABLETS BLISTER
IDE HARIDWAR 249403
INDIA
3673 NDA/MAL/H COSMOS LTD. ASTRA PHARMA GRISO-500 GRISEOFULVI 500MG COSMOS LTD.-RANGWE KENYA ORAL SOLID 1.0X10.0X 7/1/1998
DP/8009 (U) LIMITED N ROAD; OFF LUNGA LUNGA ORDINARY 10.0
NAIROBI BLISTER
3674 NDA/MAL/H COSMOS LTD. ASTRA PHARMA METROZOL METRONIDAZ 200MG COSMOS LTD.-RANGWE KENYA ORAL SOLID 1.0X10.0X 7/1/2001
DP/8010 (U) LIMITED E TABLETS OLE ROAD; OFF LUNGA LUNGA ORDINARY 10.0
ROAD. P.O BOX 414 33, FILM- TABLET
NAIROBI COATED BLISTER,1.
TABLETS 0X1000.0
TABLET
CONTAIN
ER
3675 NDA/MAL/H SWISS SHREEJI D-FEN DICLOFENAC 25MG/ML SWISS PARENTERALS LTD- INDIA PARENTERAL 1.0X5.0X3 7/1/2011
DP/8015 PARENTERALS PHARMACEUTIC SODIUM 809 KERALA IND ESTATE ORDINARY .0 ML
AHMEDABAD 382220 ,1.0X10.0X
GUJARAT INDIA 1.0X10.0X
3.0 ML
AMPOULE
3676 NDA/MAL/H CIPLA QUALITY LAMIVIR- LAMIVUDINE 150MG CIPLA LTD.- -PLOT NO INDIA ORAL SOLID 1.0X10.0X 7/1/2001
DP/8021 LIMITED CHEMICALS LTD - 150 L/139 TO L/146, VERNA ORDINARY 10.0
HUMAN TABLETS INDUSTRIAL ESTATE, FILM- TABLET
VERNA, SOUTH GOA COATED BLISTER,1.
DISTRICT, 403722 GOA TABLETS 0X60.0
TABLET
BOTTLE
3677 NDA/MAL/H CIPLA LTD. QUALITY LAMIVUDIN LAMIVUDINE 30MG CIPLA LTD.- -PLOT NO INDIA ORAL SOLID 1.0X60.0 7/1/2016
DP/8022 CHEMICALS LTD - E + + +50MG + L/139 TO L/146, VERNA ORDINARY TABLET
HUMAN NEVIRAPIN NEVIRAPINE 60MG INDUSTRIAL ESTATE, FILM- BOTTLE
E+ + VERNA, SOUTH GOA COATED
ZIDOVUDIN ZIDOVUDINE DISTRICT, 403722 GOA TABLETS
E
3678 NDA/MAL/H DENK BENLE CONSULT AMOXICLA AMOXICILLIN 500 MG + PENCEF PHARMA GMBH- GERMANY ORAL SOLID 1.0X2.0X8 7/1/2011
DP/8023 PHARMA LIMITED V-DENK TRIHYDRATE 62.5 MG BRITENBACHSTR ASSE 13 ORDINARY .0 TABLET
GMB H &CO. 500/62.5 + POTASSIUM D-13509 BERLIN FILM- BLISTER
KG CLAVULANAT COATED
E TABLETS
3679 NDA/MAL/H CIPLA LTD. QUALITY ABACAVIR ABACAVIR 600 MG + CIPLA LTD-A-33 & A- INDIA ORAL SOLID 1.0X30.0 7/1/2011
DP/8032 CHEMICALS LTD - SULFATE/LA SULFATE + 300 MG 37/2/2 MIDC ORDINARY TABLET
HUMAN MIVUDINE LAMIVUDINE PATALGANGA 410220 FILM- BOTTLE
COATED
TABLETS
3680 NDA/MAL/H DAFRA LABOREX RABEZOL RABEPRAZOL 20MG BİLİM PHARMACEUTICALS- TURKEY ORAL SOLID 1.0X14.0 7/1/2017
DP/8043 PHARMA UGANDA E SODIUM GOSB 41480 GEBZE- ORDINARY TABLET
GMBH LIMITED KOCAELİ/TURKE TABLETS BLISTER
S (PTY) LTD LIMITED MOOSWADALLE 179090, CAPSULES CAPSULE
FREIBERG GERMANY BLISTER
3682 NDA/MAL/H PFIZER LABOREX PROSTIN E2 DINOPROSTO 3MG PHARMACIA AND UPJOHN BELGIUM VAGINAL 1.0X4.0 7/1/1997
DP/8062 LABORATORIE UGANDA NE S.P.A-RIJKSWEG 12, B- TABLETS TABLET
S (PTY) LTD LIMITED 2870 PUURS STRIP
BELGIUM
3683 NDA/MAL/H NOVARTIS SURGIPHARM TRILEPTAL OXCARBAZEPI 300MG NOVARTIS PHARMA SPA,- ITALY ORAL SOLID 1.0X50.0 7/1/1997
DP/8073 PHARMA AG (U) LIMITED NE TORRE ANNUNZIATA ORDINARY TABLET
ITALY FILM- CONTAIN
COATED ER
TABLETS
3684 NDA/MAL/H AJANTA ABACUS APMOD ARTESUNATE 100 MG + AJANTA PHARMA LTD .-B- INDIA ORAL SOLID 1.0X6.0 7/1/2011
DP/8078 PHARMA LTD PHARMA 100/270 + 270 MG 4//5/6, MIDC ORDINARY TABLET
(AFRICA) AMODIAQUIN INDUSTRIALAREA, LAYERED BLISTER,1.
LIMITED E PAITHAN-431 128, TABLETS 0X3.0
AURANGBAD TABLET
BLISTER
3685 NDA/MAL/H MYLAN KIMSY MEDS ABACAVIR ABACAVIR 60MG + MYLAN LABORATORIES INDIA ORAL SOLID 1.0X60.0 7/1/2016
DP/8082 LABORATORIE LTD SULFATE + SULFATE + 30MG LIMITEDD ,-F-4 & F- ORDINARY TABLET
S LIMITED LAMIVUDIN LAMIVUDINE 12,MIDC, FILM- BOTTLE
E MALEGAON,SIRRRRAR, COATED
NASHIK -422113 TABLETS
MAHARASHTRA, INDIA.
3686 NDA/MAL/H ALKEM ABACUS ONDEM ONDANSETR 4MG/2ML ALKEM LABORATORIES INDIA PARENTERAL 1.0X10.0X 7/1/2011
DP/8087 LABORATORIE PHARMA INJECTION ON LTD-VILLAGE – THANA, ORDINARY 2.0 ML
S LIMITED (AFRICA) 4MG/2ML BADDI TEHSIL – AMPOULES AMPOULE
LIMITED NALAGARH, DIST-SOLAN
(HP), INDIA – 173205
3687 NDA/MAL/H ALKEM ABACUS ONDEM ONDANSETR 8MG/4ML ALKEM LABORATORIES INDIA PARENTERAL 1.0X10.0X 7/1/2011
DP/8088 LABORATORIE PHARMA INJECTION ON LTD-VILLAGE – THANA, ORDINARY 4.0 ML
S LIMITED (AFRICA) 8MG/4ML BADDI TEHSIL – AMPOULES AMPOULE
LIMITED NALAGARH, DIST-SOLAN
(HP), INDIA – 173205
3688 NDA/MAL/H KAMPALA KAMPALA KAM- AMOXYCILLIN 250MG KAMPALA UGANDA ORAL SOLID 1.0X1000. 7/1/1997
DP/8089 PHARMACEUT PHARMACEUTIC AMOXY PHARMACEUTICAL ORDINARY 0
ICAL AL INDUSTRIES INDUSTRIES (1996) CAPSULES CAPSULE
INDUSTRIES 1996 LIMITED LIMITED - -STRETCHER CONTAIN
(1996) LTD ROAD PLOT M444B ER,1.0X10
NTINDA KAMPALA 0.0X10.0
CAPSULE
BLISTER,1.
0X500.0
CAPSULE
CONTAIN
ER,1.0X25
3689 NDA/MAL/H RENE RENE RENEGEL ALUMINIUM 120MG+25 RENE INDUSTRIES LTD- UGANDA ORAL LIQUID 1.0X100.0 7/1/2001
DP/8091 INDUSTRIES INDUSTRIES SUSPENSIO HYDROXIDE+ 0MG PLOT 680, KAMULI ROAD, ORDINARY ML
LTD LIMITED N MAGNESIUM KIREKA, P.O BOX 6034, SUSPENSION BOTTLE
TRISILICATE KAMPALA S
3690 NDA/MAL/H LABORATORY HARLEYS KEMOXYL AMOXYCILLIN 250MG LABORATORY & ALLIED KENYA ORAL SOLID 1.0X1000. 7/1/1997
DP/8092 & ALLIED LTD UGANDA 250MG LTD-PLOT NO. 209/10349 ORDINARY 0
LIMITED OFF MOMBASA ROAD, CAPSULES CAPSULE
NAIROBI CONTAIN
P.O. BOX 42875, NAIROBI, ER,1.0X10
KENYA. .0X10.0
CAPSULE
BLISTER
3691 NDA/MAL/H CIPLA CIPLA QUALITY LAMIVUDIN ZIDOVUDINE 300MG + CIPLA QUALITY CHEMICAL UGANDA ORAL SOLID 1.0X60.0 7/1/2010
DP/8093 LIMITED CHEMICAL E/ + 150MG + INDUSTRIES LIMITED ORDINARY TABLET
INDUSTRIES ZIDOVUDIN LAMIVUDINE 200MG (CIPLAQCIL)-PLOT 1-7, 1ST FILM- BOTTLE
LIMITED E/ + RING ROAD, LUZIRA COATED
NEVIRAPIN NEVIRAPINE INDUSTRIAL PARK TABLETS
E TABLETS
150MG/300
MG/200MG
3692 NDA/MAL/H DENK BENLE CONSULT COLOSAR- LOSARTAN 100MG + DENK PHARMA GMBH GERMANY ORAL SOLID 1.0X2.0X1 7/1/2016
DP/8095 PHARMA LIMITED DENK POTASSIUM 12.5MG &CO.KG-- ORDINARY 4.0
GMB H &CO. 100/12.5 + PRINZREGENTESTR.79.816 FILM- TABLET
KG HYDROCHLOR 75 MUENCHEN, COATED BLISTER
OTHIAZIDE GERMANY, GOLLSTR, 1-D- TABLETS
845529 TITTMONING
GERMANY
3693 NDA/MAL/H ABACUS ABACUS BENZALIN BENZATHINE 2.4MEGA/ REYOUNG CHINA PARENTERAL 1.0X50.0 7/1/2011
DP/8096 PHARMA (A) PHARMA BENZYLPENIC VIAL PHARMACEUTICAL CO. ORDINARY VIAL
LTD. (AFRICA) ILLIN SODIUM LTD-NO. 6 ERLANGSHAN DRY VIALS CARTON
SHANDONG PROVINCE
P.R. 256100
3694 NDA/MAL/H SERUM NORVIK REPOITIN ERYTHROPOI 5000IU/ SERUM INSTITUTE OF INDIA PARENTERAL 1.0X6.0X0 7/1/2016
DP/8097 INSTITUTE OF ENTERPRISES 5000 ETIN 0.5ML INDIA LTD-212/2 ORDINARY .5 ML PRE-
INDIA LTD. LIMITED HADAPSAR, PUNE, 411028, PRE-FILLED FILLED
INDIA SYRINGES SYRINGE
3695 NDA/MAL/H GLAXOSMITH UNITED AMPICLOX AMPICILLIN/ 250MG/5 MEDREICH STERILAB LTD- INDIA ORAL LIQUID 1.0X100.0 7/1/1997
DP/8100 KLINE HEALTHCARE CLOXACILLIN ML 12TH MILE, OLD MADRAS ORDINARY ML
PHARMACEUT DISTRIBUTORS ROAD, VIRGONAGOR, DRY BOTTLE
ICAL KENYA LTD BANGALORE 560049, SUSPENSION
ROPS
3696 NDA/MAL/H UNOSOURCE ABACUS WELQUINE LEVOFLOXACI 500MG AKUMS DRUGS & INDIA ORAL SOLID 1.0X10.0 7/1/2016
DP/8103 PHARMA LTD. PHARMA 500 N PHARMACEUTICALS LTD.- ORDINARY TABLET
(AFRICA) PLANT III, PLOT NO. 19, FILM- BLISTER
LIMITED 20, 21, SECTOR 6-A, IIE, COATED
SIDCUL, RANIPUR, TABLETS
INDIA
3697 NDA/MAL/H ABACUS ABACUS TELPRESS TELMISARTA 40MG PSYCHOTROPICS INDIA INDIA ORAL SOLID 1.0X3.0X1 7/1/2017
DP/8104 PHARMA PHARMA 40 N LTD-PLOT NO. 46 & 49 ORDINARY 0.0
(AFRICA) (AFRICA) SECTOR -6A IIE SIDCUL TABLETS TABLET
LIMITED LIMITED RANIPUR HARIDWAR BLISTER
249403 UTTARAKHAND
3698 NDA/MAL/H UNOSOURCE ABACUS XERIN LEVOCETIRIZI 5MG + AKUMS DRUGS AND INDIA ORAL SOLID 1.0X10.0X 7/1/2017
DP/8105 PHARMA LTD. PHARMA NE 10MG PHARMACEUTICALS LTD- ORDINARY 10.0
(AFRICA) HYDROCHLOR PLANT-1 PLOT NO.19, FILM- TABLET
LIMITED IDE + 20&21 SECTOR-6A, 11E, COATED BLISTER
MONTELUKAS SIDCUL, RAHIPUR DISTT; TABLETS
T SODIUM HARIDWAR, 249403,
(UTTRAKHAND) INDIA
3699 NDA/MAL/H MEDIPHARM MEDIPHARM ORS GLUCOSE 6.75G + : MEDIPHARM INDUSTRIES UGANDA ORAL LIQUID 1.0X10.0X 7/1/2017
DP/8108 SALES INDUSTRIES ANHYDROUS+ 1.45G + LTD-PLOT 65, KAKAJJO ORDINARY 25.0 G
LIMITED (E.A) LTD TRISODIUM 1.3G + ROAD, BWEYOGERERE SOLUBLE SACHET
CITRATE+SOD 0.75G POSTAL ADDRESS POWDERS
IUM : P.O.BOX 5917,
CHLORIDE+P KAMPALA.
OTASSIUM
CHLORIDE
3700 NDA/MAL/H ABACUS ABACUS IRON FERROUS 200MG + MEDICAMEN BIOTECH LTD- INDIA ORAL SOLID 1.0X10.0X 7/1/2017
DP/8109 PHARMA LTD PHARMA FOLATE SULPHATE + 0.4MG SP-1192, A &B, PHASE –IV, ORDINARY 10.0
(AFRICA) FOLIC ACI INDUSTRIAL AREA FILM- TABLET
LIMITED BHIWADI -301019 DIST. COATED BLISTER,1
ALWAR (RAJASTHAN) TABLETS 00.0X10.0
TABLET
BLISTER
3701 NDA/MAL/H MEDLEY MEDVIN R.B.TONE MULTI- N/A MEDLEY INDIA ORAL LIQUID 1.0X1.0X2 7/1/2000
DP/8110 PHARMACEUT PHARMA SYRUP INGREDIENT PHARMACEUTICALS LTD- ORDINARY 00.0 ML
ICALS LTD LIMITED PLOT NO.18 AND 19, SYRUPS BOTTLE,1.
SURVEY NO.378/8 & 0X1.0X100
379/2, KEBRA INDUSTRIAL .0 ML
ESTATE, KACHIGAM, BOTTLE
DAMAN-396210 INDIA
3702 NDA/MAL/H MACLEODS NORVIK EMTRICITA EMTRICITABI 200MG + MACLEODS INDIA ORAL SOLID 1.0X30.0 7/1/2013
DP/8116 PHARMACEUT ENTERPRISES BINE + NE + 300MG PHARMACEUTICALS LTD .- ORDINARY TABLET
ICALS LTD LIMITED TENOFOVIR TENOFOVIR PLOT 25-27 SURVEY NO. TABLETS BOTTLE
DISOPROXIL DISOPROXIL 366 PREMEIRE
FUMARATE FUMARATE INDUSTRIAL ESTATE
KACHIGAN DAMAN
396210 INDIA
3703 NDA/MAL/H SWISS SHREEJI HALOPERID HALOPERIDO 50MG/ML SWISS PARENTERALS LTD- INDIA PARENTERAL 1.0X5.0X1 7/1/2017
DP/8119 PARENTERALS PHARMACEUTIC OL L DECANOATE 809 KERALA IND ESTATE ORDINARY .0 ML
LTD ALS LIMITED DECANOAT GIDC NEAR BAVLA DIST AMPOULES AMPOULE
E AHMEDABAD 382220 ,1.0X10.0X
GUJARAT INDIA 1.0 ML
AMPOULE
3704 NDA/MAL/H SWISS SHREEJI SWISSQUIN QUININE 300MG/ML SWISS PARENTERALS LTD- INDIA PARENTERAL 1.0X10.0X 7/1/2011
DP/8121 PARENTERALS PHARMACEUTIC E 809 KERALA IND ESTATE ORDINARY 2.0 ML
AHMEDABAD 382220
GUJARAT INDIA
3705 NDA/MAL/H DAR AL DAWA GAMA MATADOR LEVOFLOXACI 500MG DAR AL DAWA JORDAN ORAL SOLID 1.0X1.0X7 7/1/2009
DP/8125 DEVELOPMEN PHARMACEUTIC N DEVELOPMENT AND ORDINARY .0 TABLET
T AND ALS (U) LIMITED INVESTMENT CO. LTD, - TABLETS BLISTER
CO. LTD BIN AL-HUSSEIN STREET,
AMMAN, JORDAN
3706 NDA/MAL/H INCEPTA ECHO TRIDOSIL AZITHROMYCI 500MG INCEPTA BANGLADESH ORAL SOLID 1.0X2.0X3 11/29/2019
DP/8126 PHARMACUTI PHARMACY (U) N PHARMACEUTICALS LTD .- ORDINARY .0 TABLET
CALS LIMITED LIMITED DEWAN IDRIS ROAD, BARA TABLETS BLISTER,1.
RANGAMATIA, ZIRABO, 0X3.0X4.0
SAVAR-DHAKA TABLET
BLISTER
3707 NDA/MAL/H SWISS SHREEJI LIDOCAINE LIDOCAINE 2% W/V SWISS PARENTERALS LTD- INDIA PARENTERAL 1.0X30.0 7/1/2016
DP/8127 PARENTERALS PHARMACEUTIC HYDROCHL HYDROCHLOR 809 KERALA IND ESTATE ORDINARY ML VIAL
LTD ALS LIMITED ORIDE IDE GIDC NEAR BAVLA DIST VIALS
AHMEDABAD 382220
GUJARAT INDIA
3708 NDA/MAL/H MYLAN KIMSY MEDS ATOREG 20 ATORVASTATI 20MG AIZANT DRUG RESEARCH INDIA ORAL SOLID 1.0X3.0X1 7/1/2017
DP/8129 PHARMACEUT LTD N CALCIUM SOLUTIONS PVT LTD.-SY. ORDINARY 0.0
ICAL PRIVATE N0. 172 & 173,PARK FILM- TABLET
LIMITED, ROAD, DULAPALLY COATED BLISTER
INDIA VILLAGE TABLETS
3709 NDA/MAL/H DEVA SHREEJI DEGRA 100 SILDENAFIL 100MG DEVA HOLDING A. S.- TURKEY ORAL SOLID 1.0X1.0X4 5/30/2018
DP/8130 HOLDING A.S PHARMACEUTIC CITRATE ÇERKEZKÖY ORGANIZE ORDINARY .0 TABLET
ALS LIMITED SANAYI BOLGESI. FILM- BLISTER
KARAAĞAÇ MAH. COATED
ATATÜRK CAD. NO: 32 TABLETS
KAPAKLI- TEKIRDAĞ/
TURKEY
3710 NDA/MAL/H DEVA SHREEJI DEGRA SILDENAFIL 50MG DEVA HOLDING A. S.- TURKEY ORAL SOLID 1.0X4.0 7/1/2017
DP/8131 HOLDING A.S PHARMACEUTIC CITRATE ÇERKEZKÖY ORGANIZE ORDINARY TABLET
ALS LIMITED SANAYI BOLGESI. TABLETS BLISTER
KARAAĞAÇ MAH.
ATATÜRK CAD. NO: 32
KAPAKLI- TEKIRDAĞ/
TURKEY
3711 NDA/MAL/H INCEPTA ECHO ONASERON ONDANSETR 8MG/4ML INCEPTA BANGLADESH PARENTERAL 1.0X5.0X4 11/26/2019
DP/8136 PHARMACUTI PHARMACY (U) ON PHARMACEUTICALS LTD .- ORDINARY .0 ML
CALS LIMITED LIMITED DEWAN IDRIS ROAD, BARA AMPOULES AMPOULE
RANGAMATIA, ZIRABO,
SAVAR-DHAKA
3712 NDA/MAL/H INCEPTA ECHO OTICLOR CEFACLOR 500MG INCEPTA BANGLADESH ORAL SOLID 1.0X3.0X4 11/26/2019
DP/8138 PHARMACUTI PHARMACY (U) 500 PHARMACEUTICALS LTD .- ORDINARY .0
CALS LIMITED LIMITED DEWAN IDRIS ROAD, BARA CAPSULES CAPSULE
SAVAR-DHAKA
3713 NDA/MAL/H INCEPTA ECHO SEASONIX LEVOCETIRIZI 5MG INCEPTA BANGLADESH ORAL SOLID 1.0X10.0X 11/26/2019
DP/8139 PHARMACUTI PHARMACY (U) NE PHARMACEUTICALS LTD .- ORDINARY 10.0
CALS LIMITED LIMITED DIHYDROCHL DEWAN IDRIS ROAD, BARA TABLETS TABLET
ORIDE RANGAMATIA, ZIRABO, BLISTER
SAVAR-DHAKA
3714 NDA/MAL/H SANDOZ SURGIPHARM FUROSEMI FUROSEMIDE 40MG SANDOZ PVT LTD.--MIDC INDIA ORAL SOLID 1.0X4.0X2 7/1/2017
DP/8140 GMBH, (U) LIMITED DE IND, AREA KALWE BLOCK ORDINARY 5.0
KUNDL VILLAGE DIGHE NAVI TABLETS TABLET
MUMBAI 400708 BLISTER
3715 NDA/MAL/H BAYER EAST SURGIPHARM XARELTO RIVAROXABA 2.5MG BAYER PHARMA AG 51368 GERMANY ORAL SOLID 1.0X14.0 7/1/2017
DP/8142 AFRICA LTD (U) LIMITED N LEVERKUSEN-BAYER ORDINARY TABLET
LEVERKUSEN COATED
TABLETS
3716 NDA/MAL/H NAARI LTD ECHO LYDIA LEVONORGES 1.5MG NAARI PHARMA PRIVATE INDIA ORAL SOLID 1.0X1.0 7/1/2013
DP/8143 PHARMACY (U) POSTPIL TREL LIMITED-PLOT NO. 14-16, ORDINARY TABLET
LIMITED 55-57, SECTOR-5, IIE, TABLETS BLISTER
PANT NAGAR RUDRAPUR-
UTTARAKHAND
3717 NDA/MAL/H NAARI LTD ECHO MA KARE MIFEPRISTON 200MG+ NAARI PHARMA PRIVATE INDIA ORAL SOLID 1.0X5.0 7/1/2016
DP/8144 PHARMACY (U) E+ 200MCG LIMITED-PLOT NO. 14-16, ORDINARY TABLET
LIMITED MISOPROSTO 55-57, SECTOR-5, IIE, TABLETS BLISTER
L PANT NAGAR RUDRAPUR-
UTTARAKHAND
3718 NDA/MAL/H DENK PARMA BENLE CONSULT DENK- AIR MONTELUKAS 10MG DENK PHARMA GMBH & GERMANY ORAL SOLID 1.0X2.0X1 7/1/2017
DP/8145 GMBH & CO. LIMITED 10 T SODIUM CO. KG -GOLLSTR. 1 84529 ORDINARY 4.0
KG TITTMONING FILM- TABLET
COATED BLISTER
TABLETS
3719 NDA/MAL/H DENK PARMA BENLE CONSULT DENK- AIR MONTELUKAS 4MG DENK PHARMA GMBH & GERMANY ORAL SOLID 1.0X2.0X1 7/1/2017
DP/8146 GMBH & CO. LIMITED JUNIOR 4 T SODIUM CO. KG -GOLLSTR. 1 84529 ORDINARY 4.0
KG TITTMONING CHEWABLE TABLET
TABLETS BLISTER
3720 NDA/MAL/H DENK PARMA BENLE CONSULT DENK- AIR MONTELUKAS 5 MG DENK PHARMA GMBH & GERMANY ORAL SOLID 1.0X2.0X1 7/1/2017
DP/8147 GMBH & CO. LIMITED JUNIOR 5 T SODIUM CO. KG -GOLLSTR. 1 84529 ORDINARY 4.0
KG TITTMONING CHEWABLE TABLET
TABLETS BLISTER
3721 NDA/MAL/H SPARSH BIO- ABACUS FLUCLOXAC FLUCLOXACIL 500MG SPARSH BIO-TECH PVT. INDIA ORAL SOLID 1.0X10.0X 5/30/2018
DP/8148 TECH PVT LTD PHARMA ILLIN LIN LTD.--PLOT NO. 1, SURVEY ORDINARY 10.0
(AFRICA) NO. 242/243/244, VILLAGE CAPSULES CAPSULE
LIMITED LAKHABAVAD POST BLISTER
KHODIYAR COLONY
3722 NDA/MAL/H NOVARTIS SURGIPHARM JAKAVI RUXOLITINIB 20MG NOVARTIS PHARMA STEIN SWITZERLAN ORAL SOLID 1.0X4.0X1 7/1/2017
DP/8150 PHARMA (U) LIMITED AG-CH. 4002 STEIN, D ORDINARY 4.0
SERVICES INC SWITZERLAND TABLETS TABLET
BLISTER
3723 NDA/MAL/H GITTOES GITTOES AGO-C VITAMIN C 100MG AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1.0X1000. 7/1/2005
ICALS LIMITED ALS LIMITED II,VASAI,TALUKA INDL CO- CHEWABLE CONTAIN
E INDIA TABLET
STRIP
SERVICES INC STRASSE 4332, STEIN - TABLETS TABLET
SWITZERLAND BLISTER
3725 NDA/MAL/H GITTOES GITTOES AGOGCORT HYDROCORTI 1%W/W AGOG PHARMA LTD-PLOT INDIA TOPICAL 1.0X15.0 7/1/2013
DP/8154 PHARMACEUT PHARMACEUTIC SONE NO.33,SECTOR EXTERNAL G TUBE
ICALS LIMITED ALS LIMITED ACETATE II,VASAI,TALUKA INDL CO- CREAMS
E INDIA
SERVICES INC STRASSE 4332, STEIN - TABLETS TABLET
SWITZERLAND BLISTER
3727 NDA/MAL/H TATA GITTOES DIPHTHERI DIPHTHERIA + 25 LF (≥ 30 BIOLOGICAL E LTD-PLOT INDIA PARENTERAL 1.0X48.0X 7/1/2014
DP/8156 UGANDA PHARMACEUTIC A + TETANUS + IU)+5.5 LF NO.1, S.P ORDINARY I 0.5 ML
LIMITED ALS LIMITED TETANUS + PERTUSSIS + (≥ 40 BIOTECHNOLOGY PARK, M VIALS VIAL (1
PERTUSSIS HEPATITIS B + IU)+16 IOU PHASE II KOLTHER (V), DOSE
+ HAEMOPHILU (≥ 4.0 SHAMEERPET(M), RANGA VIAL),1.0X
HEPATITIS S TYPE B IU)+12.5M REDDY(DIST), ANDHRA 24.0X5.0
B+ CONJUGATE CG+11MCG PRADESH, INDIA 500078 ML VIAL
HAEMOPHI VACCINE (10 DOSE
LUS TYPE B VIAL)
CONJUGAT
E VACCINE
3728 NDA/MAL/H GITTOES GITTOES D LYTE- ANHYDROUS 13.50G + AGOG PHARMA LTD-PLOT INDIA ORAL LIQUID 1.0X20.5 7/1/2016
DP/8157 PHARMACEUT PHARMACEUTIC PLAIN GLUCOSE + 2.60G + NO.33,SECTOR ORDINARY G SACHET
ICALS LIMITED ALS LIMITED SODIUM 2.90G II,VASAI,TALUKA INDL CO- SOLUBLE
CHLORIDE + +1.50G/ 1L OP ESTATE LTD,GAURAI POWDERS
TRISODIUM PADA,VASAI(E)DIST.THAN
CITRATE + E INDIA
POTASSIUM
CHLORIDE
3729 NDA/MAL/H AUROBINDO GITTOES LOPINAVIR LOPINAVIR + 100MG + AUROBINDO PHARMA INDIA ORAL SOLID 1.0X60.0 7/1/2017
DP/8159 PHARMA PHARMACEUTIC + RITONAVIR 25MG LIMITED (UNIT III) -AURO ORDINARY TABLET
LIMITED ALS LIMITED RITONAVIR HOUSE, 313, BUCHUPALLY, FILM- BOTTLE
(UNIT III) QUTHUBULLAPAR(M), RR COATED
DISTRICT HYDERABAD- TABLETS
500090, ANDHERA
PRADESH, INDIA.
3730 NDA/MAL/H FOUNTIL LIFE PHILLIPS ULGICID ALGINIC 200MG+25 STEDMAN INDIA ORAL LIQUID 1.0X200.0 7/1/2017
DP/8160 SCIENCES PVT PHARMACEUTIC (CHERRY ACID+ 0MG+250 PHARMACEUTICALS PVT ORDINARY ML
LTD. ALS (UGANDA) FLAVOUR) MAGNESIUM MG+250M LTD...-C-4, SIDCO SUSPENSION BOTTLE
LIMITED HYDROXIDE+ G+125MG/ PHARMACEUTICAL S
ALUMINIUM 15ML COMPLEX ALATHUR,
HYDROXIDE + THIRUPORUR
MAGNESIUM
TRISILICATE
+SIMETICONE
3731 NDA/MAL/H BHARAT ABACUS HUMOG 75 HIGHLY 75 IU + 75 BHARAT SERUMS AND INDIA PARENTERAL 1.0X1.0 7/1/2017
DP/8162 SERUMS AND PHARMA HP PURIFIED IU/ 150 I.U VACCINES LTD- PLOT NO. ORDINARY VIAL
VACCINES LTD (AFRICA) MENOTROPHI VIAL K-27 ADDITIONAL MIDC DRY VIALS CARTON +
LIMITED N[ AMBERNATH (E ) 412 501 1*1 ML
CORRESPOND AMPOULE
ING TO OF
FOLLICLE 0.9%W/V
STIMULATING NACL
HORMONE
ACTIVITY
(FSH) 75 IU +
LUTEINISING
3732 NDA/MAL/H PALASH SUPER MEDIC ZIMYCIN AZITHROMYCI 200MG SAGA LABORATORIES-- INDIA ORAL LIQUID 1.0X1.0X1 9/26/2018
DP/8169 PHARMA.B LTD N DIHYDRATE /5ML SURVEY NO.198/2 & 198/3 ORDINARY 5.0 ML
CHACHRAWADI VASNA, DRY BOTTLE
TAL; SANAND SUSPENSION
AHMEDABAD 382210. S/SYRUPS/D
ROPS
3733 NDA/MAL/H FOUNTIL LIFE PHILLIPS ULGICID ALGINIC + 200MG+25 STEDMAN INDIA ORAL LIQUID 1.0X200.0 7/1/2017
DP/8170 SCIENCES PVT PHARMACEUTIC (PINEAPPLE MAGNESIUM 0MG+250 PHARMACEUTICALS PVT ORDINARY ML
LTD. ALS (UGANDA) FLAVOUR) HYDROXIDE MG+250M LTD...-C-4, SIDCO SUSPENSION BOTTLE
LIMITED +DRIED G+125MG/ PHARMACEUTICAL S
ALUMINIUM 15ML COMPLEX ALATHUR,
HYDROXIDE + THIRUPORUR
MAGNESIUM
TRISILICATE
+SIMETICONE
3734 NDA/MAL/H GITTOES GITTOES NYSTAGO NYSTATIN 500,000I.U AGOG PHARMA LTD-PLOT INDIA ORAL SOLID 1.0X1.0X1 7/1/2005
DP/8178 PHARMACEUT PHARMACEUTIC TABLETS NO.33,SECTOR ORDINARY 0.0
ICALS LIMITED ALS LIMITED II,VASAI,TALUKA INDL CO- COATED TABLET
OP ESTATE LTD,GAURAI TABLETS BLISTER,1.
E INDIA TABLET
BOTTLE,1.
0X10.0X10
.0 TABLET
BLISTER
3735 NDA/MAL/H COSMOS LTD ASTRA PHARMA COSMOL PARACETAM 500MG COSMOS LIMITED - KENYA ORAL SOLID 1.0X50.0X 7/1/1997
DP/8180 (U) LIMITED TABLETS OL RANGWA ROAD, OFF ORDINARY 2.0
500MG LUNGA LUNGA ROAD, TABLETS TABLET
INDUSTRIAL AREA STRIP,1.0X
100.0
TABLET
CONTAIN
ER,1.0X10
00.0
TABLET
CONTAIN
ER
3736 NDA/MAL/H AFRICURE ROYAL PHARMA TETRASIM TETRACYCLIN 250MG AFRICURE INDIA ORAL SOLID 1.0X10.0X 7/1/2008
DP/8184 PHARMACEUT 2011 LIMITED E PHARMACEUTICALS ORDINARY 10.0
ICALS (INDIA) HYDROCHLOR (INDIA) PRIVATE LIMITED CAPSULES CAPSULE
LTD IDE (755793)-PLOT 9- BLISTER,1.
INDIA. ER,1.0X50
0.0
CAPSULE
CONTAIN
ER
3737 NDA/MAL/H AFRICURE ROYAL PHARMA INDOSIM INDOMETHAC 25MG AFRICURE INDIA ORAL SOLID 1.0X10.0X 7/1/2008
DP/8185 PHARMACEUT 2011 LIMITED IN PHARMACEUTICALS ORDINARY 10.0
ICALS (INDIA) (INDIA) PRIVATE LIMITED CAPSULES CAPSULE
LTD (755793)-PLOT 9- BLISTER,1.
INDIA. ER
3738 NDA/MAL/H AUROBINDO GITTOES LAMIVUDIN LAMIVUDINE 150MG + AUROBINDO PHARMA LTD INDIA ORAL SOLID 1.0X60.0 7/1/2011
DP/8188 PHARMA LTD PHARMACEUTIC E + + 300MG + UNIT VII-SEZ SURVEY NO. ORDINARY TABLET
ALS LIMITED ZIDOVUDIN ZIDOVUDINE 200MG 411/P,425/P, 434/P, 435/P FILM- BOTTLE
E+ + AND 458/P PLOT NO S1 ( COATED
NEVIRAPIN NEVIRAPINE PART) SPECIAL ECONOMIC TABLETS
E ZONE GREEN INDUSTRIAL
PARK POLEPALLY
VILLAGRE ANDHRA
PRADESH 509302
3739 NDA/MAL/H AUROBINDO GITTOES LAMIVUDIN LAMIVUDINE 150 MG AUROBINDO PHARMA LTD INDIA ORAL SOLID 1.0X60.0 7/1/2005
DP/8190 PHARMA LTD PHARMACEUTIC E TABLETS UNIT III-AUROBINDO ORDINARY TABLET
ALS LIMITED PHARMA LTD UNIT III TABLETS BOTTLE
SURVEY NO. 313
BACHUPALLY VILLAGE
QUTHUBULLAPUR
MANDAL RANGA REDDY
DISTRICT (A.P)
3740 NDA/MAL/H AUROBINDO GITTOES DIDANOSIN DIDANOSINE 400MG AUROBINDO PHARMA LTD- INDIA ORAL SOLID 1.0X30.0 7/1/2009
DP/8191 PHARMA LTD PHARMACEUTIC E DELAYED- DELAYED- UNIT III-SURVEY RETARD CAPSULE
ALS LIMITED RELEASE RELEASE NO.313,BACHUPALLY CAPSULES BOTTLE
VILLAGE,QUTHUBULLAPU
R MANDAL R.R
DISTRICT(A.P),INDIA
3741 NDA/MAL/H MACLEODS NORVIK ECOX 400 ETHAMBUTO 400MG MACLEODS INDIA ORAL SOLID 1.0X10.0X 7/1/2005
DP/8193 PHARMACEUT ENTERPRISES L PHARMACEUTICALS LTD.- ORDINARY 10.0
ICALS LTD LIMITED PLOT NO. 25-27 SURVEY TABLETS TABLET
NO. 366, BLISTER,1.
PREMIER INDUSTRIAL 0X1000.0
ESTATE, KACHIGAM, TABLET
DAMAN (UT) - 396210, CONTAIN
INDIA. ER
MACLEODS
PHARMACEUTICALS LTD- -
PLOT 25-27, SURVEY NO.
306, PREMIER INDUSTRIAL
3742 NDA/MAL/H MACLEODS NORVIK SOLONEX- ISONIAZID 100MG MACLEODS INDIA ORAL SOLID 1.0X10.0X 7/1/2005
DP/8194 PHARMACEUT ENTERPRISES 100 PHARMACEUTICALS LTD .- ORDINARY 10.0
ICALS LTD LIMITED PLOT 1 & 2 MAHIM ROAD TABLETS TABLET
NEAR KULDEEP NAGAR, BLISTER,1.
PALGHAR (W) 401 404 0X1000.0
INDIA TABLET
CONTAIN
ER,1.0X24
.0X28.0
TABLET
BLISTER
3743 NDA/MAL/H MACLEODS NORVIK RH-COM RIFAMPICIN 150MG MACLEODS INDIA ORAL SOLID 1.0X10.0X 7/1/2005
DP/8195 PHARMACEUT ENTERPRISES & ISONIAZID +75MG PHARMACEUTICALS LTD- ORDINARY 10.0
ICALS LTD LIMITED BLOCK N3, VILLAGE TABLETS TABLET
THEDA, P.O. LODHI STRIP,1.0X
MAJRA, TEHSIL BADDI, 24.0X28.0
DIST. SOLAN, HIMACHAL TABLET
PRADESH 174101 BLISTER,1.
MACLEODS 0X3.0X28.
PHARMACEUTICALS LTD .- 0 TABLET
PLOT 1 & 2 MAHIM ROAD BLISTER
NEAR KULDEEP NAGAR,
PALGHAR (W) 401 404
3744 NDA/MAL/H EGYPTIAN WIDE AMIKACIN AMIKACIN 500MG/2 EGYPTIAN EGYPT PARENTERAL 1.0X2.0 7/1/2017
DP/8197 INTERNATION SPECTRUM SULPHATE ML INTERNATIONAL ORDINARY ML VIAL
AL ENTERPRISES PHARMACEUTICAL VIALS
COMPANY
3745 NDA/MAL/H MEDLEY MEDVIN XYMEX MULTI- MULTI- MEDLEY INDIA ORAL LIQUID 1.0X15.0 7/1/1999
DP/8198 PHARMACEUT PHARMA DROPS INGREDIENT INGREDIEN PHARMACEUTICALS LTD- ORDINARY ML
ICALS LTD LIMITED T PLOT NO.18 AND 19, DROPS BOTTLE
SURVEY NO.378/8 &
ESTATE, KACHIGAM,
DAMAN-396210 INDIA
3746 NDA/MAL/H MEDLEY MEDVIN XYMEX MULTIVITAMI MULTI- MEDLEY INDIA ORAL LIQUID 1.0X200.0 7/1/2000
DP/8199 PHARMACEUT PHARMA SYRUP N/ INGREDIEN PHARMACEUTICALS LTD- ORDINARY ML
ICALS LTD LIMITED DIASTASE/PE T PLOT NO.18 AND 19, SYRUPS BOTTLE
PSIN SURVEY NO.378/8 &
ESTATE, KACHIGAM,
DAMAN-396210 INDIA
3747 NDA/MAL/H MEDIPHARM MEDIPHARM ORS GLUCOSE 6.75G + MEDIPHARM INDUSTRIES( UGANDA ORAL LIQUID 1.0X10.4 7/1/2017
DP/8200 SALES INDUSTRIES ORANGE ANHYDROUS 1.45G + EA) LTD-PLOT 65 KAKAJJO ORDINARY G SACHET
LIMITED (E.A) LTD + TRISODIUM 1.3G + ROAD BWEYOGERERE SOLUBLE
CITRATE + 0.75G / P.O.BOX POWDERS
SODIUM SACHET 6218,KAMPALA,UGANDA
CHLORIDE +
POTASSIUM
CHLORIDE
3748 NDA/MAL/H CIRON DRUGS RENE CENTROZIN CETIRIZINE 5MG/5ML CIRON DRUGS & INDIA ORAL LIQUID 1.0X60.0 7/1/2017
DP/8201 AND PHARMACY LTD E HYDROCHLOR PHARMACEUTICALS PVT ORDINARY ML
PHARMACEUT IDE LTD--N-118, 119 MIDC SYRUPS BOTTLE
ICALS PVT LTD TARAPUR BOISAR DIST
THANE 4011 506
3749 NDA/MAL/H MACLEODS NORVIK ISONIAZID ISONIAZID 300MG MACLEODS INDIA ORAL SOLID 1.0X3.0X2 7/1/2017
DP/8202 PHARMACEUT ENTERPRISES PHARMACEUTICALS LTD.- ORDINARY 8.0
ICALS LTD LIMITED PLOT NO. 25-27 SURVEY TABLETS TABLET
NO. 366, BLISTER,1.
PREMIER INDUSTRIAL 0X10.0X10
ESTATE, KACHIGAM, .0 TABLET
DAMAN (UT) - 396210, BLISTER,1.
INDIA. 0X24.0X28
OXALIS LABS--VILLAGE .0 TABLET
THEDA,P.O.LODHIMAJRA BLISTER
,TEHSIL BADDI,DIST
.SOLAN (HIMACHAL
3750 NDA/MAL/H FRESENIUS SURGIPHARM DOPAMINE DOPAMINE 200MG/5 FRESNIUS KABI SOUTH PARENTERAL 1.0X10.0X 7/1/2017
DP/8204 KABI (U) LIMITED HCL HYDROCHLOR ML MANUFACTURING SA AFRICA ORDINARY 5.0 ML
MANUFACTU FRESENIUS IDE (PTY) LTD-6 GIBAUD ROAD AMPOULES AMPOULE
RING S.A KORSTEN PORT ELIZABETH
(PTY) LTD 6020
3751 NDA/MAL/H BRAWN ESCORTS BRULEXIN CEFALEXIN 125MG/5 BRAWN LABORATORIES INDIA ORAL LIQUID 1.0X100.0 7/1/2017
DP/8206 LABORATORIE PHARMACEUTIC MONOHYDRA ML LTD.-13, NIT, INDUSTRIAL ORDINARY ML
S LTD ALS LIMITED TE AREA, FARIDABAD-121001, DRY BOTTLE
HARYANA SUSPENSION
S/SYRUPS/D
ROPS
3752 NDA/MAL/H NOVARTIS SURGIPHARM ZOMETA ZOLEDRONIC 4MG/5ML NOVARTIS PHARMA STEIN SWITZERLAN PARENTERAL 1.0X1.0 7/1/2017
DP/8207 PHARMA (U) LIMITED ACID AG ;- D ORDINARY VIAL
SERVICES INC SCHAFFHAUSERSTRASSE INFUSION CARTON
CH 4332 STEIN- VIALS/BOTTL
SWITZERLAND ES
3753 NDA/MAL/H CIRON RENE CHLORAMP CHLORAMPH 1G CIRON DRUGS AND INDIA PARENTERAL 1.0X25.0X 7/1/2007
DP/8208 DRUGS & PHARMACY LTD HENICOL ENICOL PHARMACEUTICALS PVT ORDINARY 1.0 G VIAL
PHARMACEUT SODIUM SODIUM LTD-N-118 M.I.D.C, DRY VIALS
ICAL PVT LTD SUCCINATE SUCCINATE TAAPUR,BOISAR,DIST.THA
3754 NDA/MAL/H CIRON DRUGS RENE HYDROCOR HYDROCORTI 100MG CIRON DRUGS & INDIA PARENTERAL 1.0X50.0X 7/1/2007
DP/8210 & PHARMACY LTD TISONE SONE PHARMACEUTICALS PVT ORDINARY 100.0 MG
PHARMACEUT SODIUM LTD--N-118, 119 MIDC DRY VIALS VIAL
ICALS PVT LTD SUCCINATE TARAPUR BOISAR DIST
FOR THANE 4011 506
INJECTION
BP
3755 NDA/MAL/H SHELYS BETA MUCO- SALBUTAMOL 2MG/5ML BETA HEALTHCARE KENYA ORAL LIQUID 1.0X100.0 7/1/2010
DP/8211 PHARMACEUT HEALTHCARE ASTHALIN + + INTERNATIONAL LTD - - ORDINARY ML
ICALS LTD UGANDA SYRUP BROMHEXINE 4MG/5ML PLOT SYRUPS BOTTLE
LIMITED NO.209/6554,MOGADISHU
INDUSTRIAL AREA,
P.O.BOX 42569-001000
NAIROBI,KENYA
3756 NDA/MAL/H FDC LTD AIVEEN (U) BACTIGEN GENTAMICIN 0.3%W/V FDC LIMITED -B-8, INDIA OPHTHALMI 1.0X5.0 7/1/1998
DP/8212 LIMITED EYE/EAR M.I.D.C., INDUSTRIAL C VIALS ML
DROPS AREA, WALUJ – VIAL,1.0X
AURANGABAD- 431 136 10.0 ML
MAHARASHTRA, INDIA. VIAL
3757 NDA/MAL/H FDC LTD AIVEEN (U) ZOCON 200 FLUCONAZOL 200MG FDC LTD.-L-56/L-57,PHASE INDIA ORAL SOLID 1.0X5.0X2 7/1/2001
DP/8213 LIMITED E II-D, VERNA INDUSTRIAL ORDINARY .0 TABLET
ESTATE,VERNA-403722, TABLETS BLISTER
SALCETE,GOA, INDIA
3758 NDA/MAL/H SWISS SHREEJI SEFOTAX CEFOTAXIME 1G SWISS PARENTERALS LTD, INDIA PARENTERAL 1.0X1.0 G 7/1/2017
DP/8216 PARENTERALS PHARMACEUTIC SODIUM UNIT- II-PLOT NO. 402,412- ORDINARY VIAL
LTD ALS LIMITED 414 KERALA INDUSTRIAL DRY VIALS
ESTATE, GIDC, NEAR
BAVLA, DIST: AHMEDABAD
3759 NDA/MAL/H PHARCO WIDE DECLOPHE DICLOFENAC 12.5MG PHARCO EGYPT RECTAL 1.0X5.0 7/1/2017
DP/8218 PHARMACEUT SPECTRUM N 12.5 SODIUM PHARMACEUTICALS LTD- SYSTEMIC SUPPOSIT
ICALS ENTERPRISES KILO 31 ALEXANDRIA, PAEDIATRIC ORY STRIP
(U) LIMITED CAIRO DESERT ROAD, SUPPOSITORI
ARAB REPUBLIC OF EGYPT. ES
ALEXANDRIA EGYPT
3760 NDA/MAL/H NATIONAL ANDYCO NEMADOL TRAMADOL 50MG/ML NATIONAL HEALTHCARE NEPAL PARENTERAL 1.0X5.0X2 7/1/2017
DP/8221 HEALTHCARE PHARMACY HYDROCHLOR PVT LTD-CHHATAPIPRA 3 ORDINARY .0 ML
(UGANDA) LTD IDE BARA AMPOULES AMPOULE
3761 NDA/MAL/H MICRO LABS LABOREX LUBREX SODIUM 0.5%W/V MICRO LABS LTD ..-57, INDIA OPHTHALMI 1.0X10.0 7/1/2017
DP/8222 LTD UGANDA CARBOXYMET SIPCOT INDUSTRIAL C DROPS ML
LIMITED HYL COMPLEX, HOSUR-635126, BOTTLE
CELLULOSE TAMIIL NADU
3762 NDA/MAL/H EGYPTIAN WIDE OPTIGENT GENTAMICIN 0.3%W/W EGYPTIAN EGYPT OPHTHALMI 1.0X5.0 G 7/1/2017
DP/8224 INTERNATION SPECTRUM OINTMENT SULFATE INTERNATIONAL C TUBE
AL ENTERPRISES PHARMACEUTICAL OINTMENTS
PHARMACEUT (U) LIMITED INDUSTRIES CO. A.R.E-
COMPANY EGYPT
3763 NDA/MAL/H LINCOLN METRO ARTELIN 60 ARTESUNATE 60MG LINCOLN PARENTERAL LTD- INDIA PARENTERAL 1.0X60.0 7/1/2017
DP/8225 PARENTERAL PHARMACEUTIC 11, TRIMUL ESTATE ORDINARY MG VIAL +
LIMITED ALS LIMITED KHATRAJ DISI. DRY VIALS 1*1 ML
GANDHINAGAR-38272, AMPOULE
GUJARAT OF
5.0%W/V
SODIUM
BICARBO
NATE
INJECTIO
N B.P +
1*5 ML
3764 NDA/MAL/H DEVA SHREEJI SALRES SALBUTAMOL 120.5MCG/ DEVA HOLDING A. S.- TURKEY LUNG 1.0X200.0 7/1/2017
DP/8226 HOLDING A.S PHARMACEUTIC SULPHATE SPRAY ÇERKEZKÖY ORGANIZE ADMINISTRA METERED
ALS LIMITED SANAYI BOLGESI. TION CFC- DOSE
KARAAĞAÇ MAH. FREE CANNISTE
ATATÜRK CAD. NO: 32 METERED- R
KAPAKLI- TEKIRDAĞ/ DOSE
TURKEY INHALER
3765 NDA/MAL/H HETERO LABS AIVEEN (U) ALZER 5 DONEPEZIL 5MG HETERO LABS LTD. UNIT INDIA ORAL SOLID 1.0X10.0X 7/1/2017
DP/8227 LTD LIMITED HYDROCHLOR (V) .-S.N0.439, 440, 441& ORDINARY 10.0
IDE 458, APIIC, PHARMA SEZ, FILM- TABLET
POLLEPALLY (VILLAGE), COATED BLISTER,1.
JADCHERLA (MANDAL) TABLETS 0X3.0X1.0
MAHABOOB NAGAR (DIST)- X10.0
509301 INDIA. TABLET
BLISTER
3766 NDA/MAL/H AFRICURE ROYAL PHARMA VITAMIN B- VITAMINS B1 1MG AFRICURE INDIA ORAL SOLID 1.0X10.0X 7/1/2017
DP/8228 PHARMACEUT 2011 LIMITED COMPLEX + B2 + B6 + +1MG PHARMACEUTICALS ORDINARY 10.0
ICALS (INDIA) (BEEKO) NIACINAMIDE +1MG (INDIA) PRIVATE LIMITED OTHER TABLET
LTD +15MG (755793)-PLOT 9- COATED BLISTER
12,DEWAN & SONS TABLETS
INDUSTRIAL. AREA,
INDIA.
3767 NDA/MAL/H DENK PARMA BENLE CONSULT ANASTROZ ANASTROZOL 1MG HAUPT PHARMA GMBH & GERMANY ORAL SOLID 1.0X3.0X1 7/1/2017
DP/8231 GMBH & CO. LIMITED OLE DENK E CO KG- ORDINARY 0.0
KG SCHLEEBRUGGENKAMP FILM- TABLET
15, 48159 MUNSTER, COATED BLISTER
GERMANY TABLETS
3768 NDA/MAL/H CADILA ABACUS COLSTIM FILGRASTIM 300µG/ML CADILA HEALTHCARE LTD.-- INDIA PARENTERAL 1.0X1.0 7/1/2017
DP/8233 HEALTH CARE PHARMA PLOT SURVEY NO. 23, ORDINARY ML PRE-
LIMITED (AFRICA) 25/P, 37, 40/P, 42 TO 47 PRE-FILLED FILLED
LIMITED SARKHEJ BAVLA N.H SYRINGES SYRINGE
NO.8A OPP.RAMDEV
MASALA CHANGODAR
TAL. SANAND DIST
AHMEDABAD 382213
3769 NDA/MAL/H IMMUCOR SUPER MEDIC ACEPAR ACECLOFENA 100MG + DAWA LTD-BABA DOGO KENYA ORAL SOLID 1.0X10.0 7/1/2017
DP/8235 LTD C+ 15MG + ROAD RUARAKA ORDINARY TABLET
SERRATIOPEP 500MG FILM- BLISTER
TIDASE + COATED
PARACETAM TABLETS
OL
3770 NDA/MAL/H MERIDIAN ABACUS METROSUP METRONIDAZ 500MG MERIDIAN ENTERPRISES INDIA RECTAL 1.0X2.0X5 7/1/2017
DP/8238 ENTERPRISES PHARMA P 500 OLE PVT. LTD--PLOT NO. 418, SYSTEMIC .0
GUJARAT,INDIA
3771 NDA/MAL/H GLAXOSMITH UNITED UMBIPRO CHLORHEXIDI 4%W/W GLAXO OPERATIONS UK UNITED TOPICAL 1.0X7.0 7/1/2017
DP/8239 KLINE HEALTHCARE GEL NE LTD---HARMIRE ROAD, KINGDOM EXTERNAL SACHET
PHARMACEUT DISTRIBUTORS BARNARD CASTLE, GELS AND CARTON
ICAL KENYA LTD DURHAM DL128 DT UK SOLS
LTD
3772 NDA/MAL/H OCHOA SUPER MEDIC TRANEXAM TRANEXAMIC 500MG + AUROCHEM INDIA ORAL SOLID 1.0X3.0X1 7/1/2017
DP/8243 LABORATORIE LTD IC ACID + ACID + 250MG LABORATORIES (I) PVT LTD- ORDINARY 0.0
S MEFENAMI MEFENAMIC -8 PALGHAR TALUKA FILM- TABLET
C ACID ACID INDUSTRIAL CO-OP COATED BLISTER
ESTATE LTD PALGHAR 401 TABLETS
404 DIST THANE
3773 NDA/MAL/H MYLAN KIMSY MEDS HERTRAZ TRASTUZUMA 440MG BIOCON LIMITED-SPECIAL INDIA PARENTERAL 1.0X440.0 7/1/2017
DP/8244 PHARMACEUT LTD 440 B (R-DNA ECONOMIC ZONE, ORDINARY MG VIAL
ICAL PRIVATE ORIGIN) PLOT NO.2-4, PHASE IV, DRY VIALS ,1X2X10M
LIMITED, BOMMASANDRA- JIGANI L VIALS OF
INDIA LINK ROAD WFI
BANGALORE-560 099
3774 NDA/MAL/H SAKAR ROYAL PHARMA E-DOL TRAMADOL 50MG/ML SAKAR HEALTH CARE PVT, INDIA PARENTERAL 1.0X2.0X5 7/1/2017
DP/8247 HEALTH CARE 2011 LIMITED HYDROCHLOR LTD-BLOCK NO. 10-13,M.N ORDINARY .0X2.0 ML
PVT .LTD IDE DESAI PETROL AMPOULES AMPOULE
PUMP,SARKHEJ-BAVLA
ROAD,VILLAGE
CHANGODAR DIST
AHMEDABAD 382-
213,GUJARAT-INDIA
3775 NDA/MAL/H CIPLA LTD. QUALITY LUMARTEM ARTEMETHER 20MG+120 CIPLA LTD INDORE-PLOT 9 INDIA ORAL SOLID 1.0X12.0 7/1/2017
DP/8250 CHEMICALS LTD - DT +LUMEFANTR MG & 10 INDORE SEZ ORDINARY TABLET
HUMAN INE PITHAMPUR M.P 454 775 SOLUBLE BLISTER,1.
TABLETS 0X6.0
TABLET
BLISTER,1.
0X30.0X6.
0 TABLET
BLISTER,1.
0X30.0X12
.0 TABLET
BLISTER
3776 NDA/MAL/H FRESENIUS SURGIPHARM PARACETA PARACETAM 10MG/ML FRESENIUS KABI AUSTRIA AUSTRIA PARENTERAL 1.0X10.0X 7/1/2017
DP/8252 KABI SOUTH (U) LIMITED MOL OL GMBH-AUSTRIA GMBH ORDINARY 50.0 ML
AFRICA (PTY) FRESENIUS HAFNERSTRASSEM 36 INFUSION VIAL,1.0X
LIMITED 8055 GRAZ VIALS/BOTTL 10.0X100.
ES 0 ML VIAL
3777 NDA/MAL/H REYOUNG ROYAL PHARMA DICLOFENA DICLOFENAC 25MG/ML REYOUNG CHINA PARENTERAL 10.0X10.0 7/1/2017
DP/8253 PHARMACEUT 2011 LIMITED C SODIUM SODIUM PHARMACEUTICAL CO. ORDINARY X3.0 ML
ICAL CO LTD LIMITED-NO. 1 RUIYANG AMPOULES AMPOULE
ROAD YIYUAN COUNTY,
SHANDONG PROVINCE, P.
R. CHINA
3778 NDA/MAL/H MICRO LABS LABOREX GRAMOCEF- CEFIXIME 200MG + MICRO LABS LIMITED, INDIA ORAL SOLID 1.0X10.0 7/1/2017
DP/8254 LTD UGANDA CV TRIHYDRATE 125MG BOMMASANDRA -PLOT ORDINARY TABLET
LIMITED + NO. 121-124 4TH PHASE FILM- STRIP
CLAVULANIC K.I.A.D.B BOMMASANDRA COATED
ACID INDUSTRIAL AREA ANEKAL TABLETS
TALUK BANGALORE 560
099
3779 NDA/MAL/H CACHET ASTRA PHARMA EMITINO ONDANSETR 2MG/5ML CACHET INDIA ORAL LIQUID 1.0X30.0 7/1/2017
DP/8264 PHARMA PVT (U) LIMITED ORAL ON PHARMACEUTICALS PVT ORDINARY ML
LTD SOLUTION LTD -THANA BADDI LIQUIDS BOTTLE
173205 DISTRICT SOLAN
(HIMACHAL PRADESH)
INDIA
3780 NDA/MAL/H HETERO LABS AIVEEN (U) BICATERO BICALUTAMID 50MG HETERO LABS LTD (UNIT- INDIA ORAL SOLID 1.0X30.0 7/1/2013
DP/8274 LTD LIMITED 50 E VI)-"SY.NO. 439, 440 & ORDINARY TABLET
458,APIIC FORMULATION TABLETS BOTTLE
SEZ, POLEPALLY (V),
JEDCHERLA (M)
MAHABOOBNAGAR
DISTRICT ANDHRA
PRADESH-509301 INDIA
3781 NDA/MAL/H HETERO LABS AIVEEN (U) LETERO LETROZOLE 2.5MG HETERO LABS LTD (UNIT- INDIA ORAL SOLID 1.0X30.0 7/1/2013
DP/8275 LTD LIMITED VI)-"SY.NO. 439, 440 & ORDINARY TABLET
458,APIIC FORMULATION TABLETS BOTTLE
SEZ, POLEPALLY (V),
JEDCHERLA (M)
MAHABOOBNAGAR
DISTRICT ANDHRA
PRADESH-509301 INDIA
3782 NDA/MAL/H HETERO LABS AIVEEN (U) GEMTERO GEMCITABIN 1G HETERO LABS (UNIT VI), INDIA PARENTERAL 1.0X1.0 G 7/1/2013
DP/8276 LTD LIMITED 1G E INDIA-APIIC, ORDINARY VIAL
FORMULATION SEZ, VIALS
POLEPALLY
(V),JEDCHERLA(M)
MAHABOOBNAGER
DISTRICT ANDHRA
PRADESH-509301, INDIA.
3783 NDA/MAL/H HETERO LABS AIVEEN (U) ANATERO ANASTROZOL 1MG HETERO LABS LTD, UNIT INDIA ORAL SOLID 1.0X30.0 7/1/2013
DP/8278 LTD LIMITED E VI, INDIA-APIIC, ORDINARY TABLET
FORMULATION SEZ, TABLETS BOTTLE
POLEPALLY (V),
JEDCHERLA (M)
MAHABOOBNAGER
DISTRICT ANDHRA
PRADESH-509301, INDIA
3784 NDA/MAL/H SAKAR ROYAL PHARMA GENTACIN GENTAMICIN 80MG/2ML SAKAR HEALTH CARE PVT, INDIA PARENTERAL 1.0X2.0X6 7/1/2013
DP/8279 HEALTHCARE 2011 LIMITED SULPHATE LTD-BLOCK NO. 10-13,M.N ORDINARY .0X2.0 ML
PVT LTD DESAI PETROL AMPOULES AMPOULE
PUMP,SARKHEJ-BAVLA IN
ROAD,VILLAGE BLISTERS
CHANGODAR DIST
AHMEDABAD 382-
213,GUJARAT-INDIA
3785 NDA/MAL/H SANDOZ SURGIPHARM BINOZYT AZITHROMYCI 500MG SANDOZ SRL LTD-LIVEZENI ROMANIA ORAL SOLID 1.0X3.0 7/1/2016
DP/8282 KENYA C/O (U) LIMITED 500 N STREET 7A540472 TARGU ORDINARY TABLET
NOVARTIS MURES ROMANIA FILM- BLISTER
PHARMA COATED
3786 NDA/MAL/H ASTRA ASTRA PHARMA QUINAS QUININE 300MG ASTRA LIFE CARE(INDIA) INDIA ORAL SOLID 1.0X1000. 7/1/2009
DP/8283 PHARMA (U) (U) LIMITED SULPHATE BP PVT LTD-PLOT NO. 57/P, ORDINARY 0 TABLET
LIMITED SARKHEJ – BAVLA COATED CONTAIN
HIGHWAY, POST. RAJODA TABLETS ER,1.0X10
– 382220, TALUKA: BAVLA, .0X10.0
DIST. AHMEDABAD TABLET
BLISTER
3787 NDA/MAL/H PHARMEDIC HEALTHCARE CIPLOX- CIPROFLOXAC 500MG PHARMEDIC PAKISTAN ORAL SOLID 10.0X10.0 7/1/1997
DP/8284 LABORATORIE LTD. 5OO IN LABORATORIES LIMITED- ORDINARY TABLET
S(PVT) TABLETS 16KM MULTAN TABLETS BLISTER,1.
LIMITED ROAD,LAHORE-PAKISTAN 0X1.0X100
.0 TABLET
CONTAIN
ER
3788 NDA/MAL/H COSMOS LTD ASTRA PHARMA ISONIAZIDE ISONIAZID 100MG COSMOS LIMITED-- KENYA ORAL SOLID 10.0X10.0 7/1/2001
DP/8297 (U) LIMITED TABLETS RANGWA ROAD, OFF ORDINARY TABLET
LUNGA LUNGA ROAD,P.O TABLETS BLISTER,1
BOX 414 33, NAIORBI 000.0
INDUSTRIAL AREA TABLET
CONTAIN
ER
3789 NDA/MAL/H NAME ROYAL PHARMA DICLOFENA DICLOFENAC 50MG AFRICURE INDIA ORAL SOLID 1.0X10.0X 7/1/2007
DP/8299 AFRICURE 2011 LIMITED C TABLETS SODIUM PHARMACEUTICALS ORDINARY 10.0
PHARMACEUT BP (INDIA) PRIVATE LIMITED FILM- TABLET
ICALS (INDIA) (755793)-PLOT 9- COATED BLISTER
PRIVATELIMIT 12,DEWAN & SONS TABLETS
ED INDUSTRIAL. AREA,
INDIA.
3790 NDA/MAL/H AFRICURE ROYAL PHARMA CIPRONE- CIPROFLOXAC 500MG AFRICURE INDIA ORAL SOLID 1.0X10.0X 7/1/2007
DP/8300 PHARMACEUT 2011 LIMITED 500 IN PHARMACEUTICALS ORDINARY 10.0
ICALS (INDIA) HYDROCHLOR (INDIA) PRIVATE LIMITED FILM- TABLET
PRIVATELIMIT IDE (755793)-PLOT 9- COATED BLISTER
ED 12,DEWAN & SONS TABLETS
INDUSTRIAL. AREA,
INDIA.
3791 NDA/MAL/H NAME ROYAL PHARMA SIMFEN IBUPROFEN 400MG AFRICURE INDIA ORAL SOLID 1.0X10.0X 7/1/2008
DP/8302 AFRICURE 2011 LIMITED 400MG PHARMACEUTICALS ORDINARY 10.0
PHARMACEUT (INDIA) PRIVATE LIMITED TABLETS TABLET
ICALS (INDIA) (755793)-PLOT 9- BLISTER,1.
PRIVATELIMIT 12,DEWAN & SONS 0X1000.0
ED INDUSTRIAL. AREA, TABLET
INDIA. ER
3792 NDA/MAL/H NAME ROYAL PHARMA METFORMI METFORMIN 500MG AFRICURE INDIA ORAL SOLID 1.0X10.0X 7/1/2008
DP/8307 AFRICURE 2011 LIMITED N 500 PHARMACEUTICALS ORDINARY 10.0
PHARMACEUT (INDIA) PRIVATE LIMITED TABLETS TABLET
ICALS (INDIA) (755793)-PLOT 9- BLISTER
PRIVATELIMIT 12,DEWAN & SONS
ED INDUSTRIAL. AREA,
INDIA.
3793 NDA/MAL/H INDUS HEALTHCARE SNOLIP ATORVASTATI 20MG INDUS PHARMA (PVT) LTD INDIA ORAL SOLID 1.0X1.0X1 7/1/2010
DP/8309 PHARMA PVT LTD. 20MG N ,-PLOTS NO. 64, 65, 66 & ORDINARY 0.0
LTD 67, SECTOR -27, KORANGI FILM- TABLET
INDUSTRIAL AREA, COATED BLISTER,1.
KARACHI - 74900 TABLETS 0X3.0X10.
0 TABLET
BLISTER
3794 NDA/MAL/H INDUS HEALTHCARE MAXPAN- CEFIXIME 100MG/5 INDUS PHARMA (PVT) LTD INDIA ORAL LIQUID 1.0X1.0X3 7/1/2010
DP/8310 PHARMA PVT LTD. 100 ML ,-PLOTS NO. 64, 65, 66 & ORDINARY 0.0 ML
LTD 67, SECTOR -27, KORANGI SUSPENSION BOTTLE
INDUSTRIAL AREA, S
KARACHI - 74900
3795 NDA/MAL/H CADILA ESCORTS TRICORT 40 TRIAMCINOL 40MG/ML CADILA INDIA PARENTERAL 1.0X1.0 11/29/2017
DP/8312 PHARMACEUT PHARMACEUTIC ONE PHARMACEUTICALS ORDINARY ML VIAL
ICALS LIMITED ALS LIMITED ACETONIDE LIMITED-1389, TRASAD VIALS
STATE, INDIA
DP/8315 CILAG ACCESS 75 STATE ROAD 933 KM 0.1 STATES ORDINARY TABLET
INTERNATION (UGANDA) MARNEY WARD GURABO FILM- BOTTLE
AL NV LIMITED PUERTO RICO 00778 COATED
TABLETS
3797 NDA/MAL/H AUROBINDO GITTOES DOLUTEGR DOLUTEGRAV 50MG + "AUROBINDO PHARMA INDIA ORAL SOLID 1.0X1.0X3 5/30/2018
DP/8316 M PHARMA PHARMACEUTIC AVIR 50 IR SODIUM + 300MG + LIMITED-UNIT –VII, SEZ, ORDINARY 0.0
LIMITED ALS LIMITED MG/ LAMIVUDINE 300MG TSIIC, PLOT NO. SI,S. NO.’S FILM- TABLET
LAMIVUDIN + TENOFOVIR 411/P, 425/P, 434/P, COATED BOTTLE
E 300 MG/ DISOPROXIL 435/P & 458/P,GREEN TABLETS
TENOFOVIR FUMARATE INDUSTRIAL PARK,
DISOPROXIL POLEPALLY VILLAGE,
FUMARATE JEDCHERLA MANDAL,
300 MG MAHABOOB NAGAR
TABLETS DISTRICT -509 302
TELANGANA STATE,
INDIA"
3798 NDA/MAL/H ACULIFE LIFE PHARMA MERONIR MEROPENEM 500MG ACULIFE HEALTHCARE INDIA PARENTERAL 1.0X500.0 11/29/2017
DP/8317 HEALTHCARE AFRICA LIMITED 500 PVT. LTD-VILLAGE ORDINARY MG VIAL
SACHANA ,TALUKA - DRY VIALS + 1*10ML
VIRAMGAM , AMPOULE
AHMEDABAD 382150 OF WFI
GUJARAT
3799 NDA/MAL/H ACULIFE LIFE PHARMA B-CANE BUPIVACAINE 5 MG/ML ACULIFE HEALTHCARE INDIA PARENTERAL 1.0X4.0 11/29/2017
DP/8318 HEALTHCARE AFRICA LIMITED HEAVY HYDROCHLOR PVT. LTD-VILLAGE ORDINARY ML
IDE BP SACHANA ,TALUKA - AMPOULES AMPOULE
VIRAMGAM ,
AHMEDABAD 382150
GUJARAT
3800 NDA/MAL/H KOPRAN TATA UGANDA ERYKO-250 ERYTHROMYC 250MG KOPRAN LTD-VILLAGE INDIA ORAL SOLID 1.0X10.0X 11/29/2017
DP/8319 LIMITED LIMITED IN STEARATE SAVROLI TAL KHARAPUR ORDINARY 10.0
TABLETS BP DIST RAIGAD 410 202 TABLETS TABLET
BLISTER,1.
0X1000.0
TABLET
CONTAIN
ER,1.0X50
0.0
TABLET
CONTAIN
ER
3801 NDA/MAL/H UNOSOURCE ABACUS PROSTAR- PROGESTERO 200 MG AKUMS DRUGS & INDIA ORAL SOLID 1.0X10.0X 1/31/2018
DP/8321 PHARMA LTD. PHARMA 200 NE PHARMACEUTICALS LTD .- ORDINARY 10.0
(AFRICA) CAPSULES 47, 48 SECTOR 6A I.I.E CAPSULES CAPSULE
LIMITED SIDCUL RANIPUR BLISTER,1.
HARIDWAR 249 403 0X3.0X10.
0
CAPSULE
BLISTER
3802 NDA/MAL/H CACHET ASTRA PHARMA LOOBID OFLOXACIN + 200MG + CACHET INDIA ORAL SOLID 1.0X10.0 11/29/2017
DP/8324 PHARMACEUT (U) LIMITED TABLETS ORNIDAZOLE 500 MG PHARMACEUTICAL PVT ORDINARY TABLET
ICALS LTD. HIMACHAL-THANA, TABLETS BLISTER
PRIVATE BADDI, HIMACHAL
LIMITED PRADESH-173 205,
INDIA
3803 NDA/MAL/H MEDOPHARM PLANET MEDOMOX AMOXICILLIN 250MG MEDOPHARM PVT LTD.- INDIA ORAL SOLID 1.0X2.0X1 11/29/2017
DP/8326 PRIVATE PHARMACEUTIC 250 DT NO. 50 KAYARAMBEDU ORDINARY 0.0
LIMITED ALS UGANDA VILLAGE GUDUVANCHERY SOLUBLE TABLET
LTD 603 203 CHENGALPET TABLETS BLISTER,1.
DISTRICT TAMIL NADU 0X3.0X10.
0 TABLET
BLISTER,1.
0X10.0X10
.0 TABLET
BLISTER
(EMBOSSE
D WITH
3804 NDA/MAL/H MICRO LABS PHILLIPS TORSINEX- TORSEMIDE 20MG MICRO LABS LTD--NO 92, INDIA ORAL SOLID 1.0X3.0X1 11/29/2017
DP/8331 LIMITED PHARMACEUTIC 20 SIPCOT, HOSUR-635 126,, ORDINARY 0.0
ALS (UGANDA) TAMIL NADU, INDIA TABLETS TABLET
LIMITED BLISTER
3805 NDA/MAL/H DEVA SHREEJI AZITRO 500 AZITHROMYCI 500MG DEVA HOLDING A. S.- TURKEY ORAL SOLID 1.0X1.0X3 11/29/2017
DP/8332 HOLDING A.S PHARMACEUTIC MG N ÇERKEZKÖY ORGANIZE ORDINARY .0 TABLET
ALS LIMITED SANAYI BOLGESI. FILM- BLISTER
KARAAĞAÇ MAH. COATED
ATATÜRK CAD. NO: 32 TABLETS
KAPAKLI- TEKIRDAĞ/
TURKEY
3806 NDA/MAL/H MICRO LABS PHILLIPS AVAS-20 ATORVASTATI 20MG MICRO LABS LTD 92 INDIA ORAL SOLID 1.0X3.0X1 11/29/2017
DP/8333 LTD 92 PHARMACEUTIC N SIPCOT -92 SIPCOT ORDINARY 0.0
SIPCOT ALS (UGANDA) HOSUR 635 126 TAMIL TABLETS TABLET
INDUSTRIAL LIMITED NADU BLISTER
3807 NDA/MAL/H RIVA WIDE RIVAMOX AMOXICILLIN 500MG RIVA PHARMA FREE ZONE- EGYPT ORAL SOLID 1.0X2.0X1 1/31/2018
DP/8335 PHARMA SPECTRUM TRIHYDRATE NASR CITY CAIRO EGYPT ORDINARY 0.0
FREE ZONE ENTERPRISES CAPSULES CAPSULE
(U) LIMITED BLISTER
3808 NDA/MAL/H MACLEODS NORVIK MONTEMA MONTELUKAS 5 MG MACLEODS INDIA ORAL SOLID 1.0X3.0X1 11/29/2017
DP/8340 PHARMACEUT ENTERPRISES C5 T SODIUM PHARMACEUTICALS ORDINARY 0.0
ICALS LTD LIMITED LTD(BLOCK N2)-VILLAGE TABLETS TABLET
THEDA,P.O LODHI BLISTER
MAJRA,TEHSIL
BADDI,HIMACHAL
PRADESH 174101
3809 NDA/MAL/H GILEAD MEDICAL GENVOYA ELVITEGRAVI 150MG + PATHEON INC.--TORONTO CANADA ORAL SOLID 1.0X30.0 1/31/2018
DP/8341 SCIENCE INC ACCESS R+COBICISTA 150MG + REGIONAL OPERATIONS ORDINARY TABLET
(UGANDA) T+EMTRICIST 200MG + 2100, SYNTEX COURT, TABLETS BOTTLE
LIMITED ABINE+TENO 10MG MISSISSAUGA, ONTARIO,
FOVIR CANADA, L5N 7K9
ALAFENAMID
E
3810 NDA/MAL/H PSA ROYAL PHARMA ANCOLIN PREGABALIN 75MG ZIM LABORATORIES INDIA ORAL SOLID 1.0X3.0X1 5/30/2018
DP/8342 INTERNATION 2011 LIMITED 75 LIMITED-B-21/22 MIDC ORDINARY 0.0
AL (EXPORT AREA KALMESHWAR OTHER CAPSULE
DIVISION OF 441501, DIST NAGPUR, CAPSULES BLISTER
PSA MAHARASHTRA
CHEMICALS
AND
PHARMACEUT
ICALS PVT.
LTD)
3811 NDA/MAL/H TROIKAA ABACUS XYKAA PARACETAM 325MG+67 TROIKAA INDIA ORAL SOLID 1.0X10.0X 11/28/2019
DP/8343 PHARMACEUT PHARMA EXTEND OL 5MG PHARMACEUTICALS LTD .- RETARD 10.0
ICALS LIMITED (AFRICA) 1000 BP(IMMEDIAT SARA INDUSTRIAL ESTATE FILM- TABLET
LIMITED E RELEASE)+ SELAQUI DEHRADUN COATED BLISTER,2.
PARACETAM 248197 UTTARAKHAND, TABLETS 0X10.0
OL INDIA TABLET
BP(EXTENDED BLISTER
RELEASE)
3812 NDA/MAL/H CACHET ASTRA PHARMA CELZA DRY CEFUROXIME 125 MG/5 ALKEM LABORATORIES INDIA ORAL LIQUID 1.0X50.0 11/29/2017
DP/8344 PHARMACEUT (U) LIMITED SYRUP AXETIL USP ML LTD--PURANA BARRIER, ORDINARY ML
ICALS VILLAGE THANA, BADDI, DRY BOTTLE
PRIVATE DISTT. SOLAN, HIMACHAL SUSPENSION
LIMITED PRADESH S/SYRUPS/D
ROPS
3813 NDA/MAL/H CACHET ASTRA PHARMA CELZA 500 CEFUROXIME 500 MG ALKEM LABORATORIES INDIA ORAL SOLID 1.0X10.0 11/29/2017
DP/8345 PHARMACEUT (U) LIMITED AXETIL USP LTD--PURANA BARRIER, ORDINARY TABLET
ICALS VILLAGE THANA, BADDI, TABLETS BLISTER
PRIVATE DISTT. SOLAN, HIMACHAL
LIMITED PRADESH
3814 NDA/MAL/H AJANTA ABACUS ADERAN 8 CANDESARTA 8MG AJANTA PHARMA LIMITED- INDIA ORAL SOLID 1.0X3.0X1 11/29/2017
DP/8346 PHARMA PHARMA N CILEXETIL B-4-5-6, MIDC AREA ORDINARY 0.0
LIMITED (AFRICA) PAITHAN, AURANGABAD, FILM- TABLET
LIMITED 431148 COATED BLISTER
DIST:AURANGABAD TABLETS
MAHARASHTRA, INDIA.
3815 NDA/MAL/H İLKO İLAÇ CORE ACCESS IRBECOR IRBESARTAN 300MG + İLKO İLAÇ SANAYI VE TURKEY ORAL SOLID 1.0X2.0X1 11/29/2017
DP/8348 SANAYI VE LIMITED PLUS + 12.5MG TICARET A. Ş-3. ORGANIZE ORDINARY 4.0
TICARET A. Ş. 300MG/12. HYDROCHLOR SANAYI BÖLGESI KUDDUSI FILM- TABLET
5MG OTHIAZIDE CAD. 23. SOK. NO:1 COATED BLISTER
3816 NDA/MAL/H TIL HARLEYS ASTYMIN-C L-LEUCINE 0.84M+1.4 TIL HEALTH CARE-PLOT INDIA ORAL LIQUID 1.0X15.0 11/29/2017
DP/8349 HEALTHCARE UGANDA DROPS USP + L- 3MG+1.84 100,WEST,R- ORDINARY ML
PVT LTD LIMITED ISOLEUCINE MG+1.18M 5,SOUTH;SRICITY DROPS BOTTLE
USP + L- G+3.66MG SEZ,CHERIVI,IRUHULAM,PS
LYSINE +1.00MG+ OT,SATYAVEDU
HYDROCHLOR 1.00MG+5. MANDAL,CHITOOR
IDE USP + L- 00MG+100 DISTRICT-ANDRA
PHENYLALANI MG PRADESH-517588, INDIA
NE USP + L-
THREONINE
USP + L-
VALINE USP+
3817 NDA/MAL/H TIL HARLEYS ASTYMIN L-LEUCINE+L- 10.3MG + TIL HEALTH CARE-PLOT INDIA ORAL LIQUID 1.0X200.0 11/29/2017
DP/8351 HEALTHCARE UGANDA SYRUP ISOLEUCINE+L- 5.9MG + 100,WEST,R- ORDINARY ML
PVT LTD LIMITED LYSINE 25MG + 5,SOUTH;SRICITY SYRUPS BOTTLE
HYDROCHLOR 5MG + SEZ,CHERIVI,IRUHULAM,PS
IDE+L- 4.2MG + OT,SATYAVEDU
PHENYLALNI 9.2MG + MANDAL,CHITOOR
NE+L- 5MG + DISTRICT-ANDRA
THREONINE+ 6.7MG + PRADESH-517588, INDIA
L- 5MG +
METHIONINE 1.5MG
+L- +25MG +
TRYPTOPHAN 5MG +
3818 NDA/MAL/H MENARINI PHILLIPS KETESSE DEXKETOPRO 50MG/2ML A. MENARINI ITALY PARENTERAL 1.0X1.0 11/26/2019
DP/8352 INTERNATION PHARMACEUTIC FEN MANUFACTURING ORDINARY AMPOULE
AL ALS (UGANDA) TROMETAMO LOGISTICS AND SERVICES AMPOULES CARTON,1
OPERATIONS LIMITED L S.R.L-VIA SETTE SANTI 3, .0X6.0
LUXEMBOUR 50131 FIRENZE AMPOULE
G S.A. CARTON,1
.0X20.0
AMPOULE
CARTON,1
.0X5.0
AMPOULE
CARTON
3819 NDA/MAL/H AJANTA ABACUS NURIFER CARBONYL 100MG+1. AJANTA PHARMA LIMITED- INDIA ORAL SOLID 1.0X3.0X1 11/29/2017
DP/8353 PHARMA PHARMA CAPSULES IRON + FOLIC 5 MG + 15 AJANTA PHARMA LIMITED ORDINARY 0.0
LIMITED (AFRICA) ACID + MCG + 75 B-4-5-6, MIDC AREA CAPSULES CAPSULE
LIMITED VITAMIN B12 MG + 61.8 PAITHAN, AURANGABAD, BLISTER
+ VITAMIN C MG 431148
+ ZINC DIST:AURANGABAD
SULFATE MAHARASHTRA, INDIA.
MONOHYDRA
TE
3820 NDA/MAL/H MEGA ABACUS ZORUXA ZOLEDRONIC 5MG/100 GLAND PHARMA LIMITTED INDIA PARENTERAL 1.0X100.0 11/29/2017
DP/8354 LIFESCIENCES PHARMA ACID ML 143-148-D P PALLY, ORDINARY ML
PUBLIC (AFRICA) QUTHUBULLAPUL INFUSION BOTTLE
COMPANY LIMITED MANDAL, RANDA REDDY VIALS/BOTTL
LTD DIST, HYBERABAD, IN-500 ES
043, INDIA
3821 NDA/MAL/H UNOSOURCE ABACUS LORFACT-D DESLORATIDI 5MG, AKUMS DRUGS & INDIA ORAL SOLID 1.0X10.0X 11/29/2017
DP/8356 PHARMA LTD PHARMA NE PHARMACEUTICALS LTD- ORDINARY 10.0
(AFRICA) 19, 20,21 SECTOR 6A IIE TABLETS TABLET
LIMITED SIDCUL RANIPUR BLISTER
HARIDWAR 249 403
3822 NDA/MAL/H FRESENIUS SURGIPHARM FRESENIUS PROPOFOL 1% W/V FRESENIUS KABI AUSTRIA AUSTRIA PARENTERAL 1.0X10.0X 11/29/2017
DP/8357 KABI SOUTH (U) LIMITED PROPOVEN GMBH PLANT GRAZ- ORDINARY 20.0 ML
AFRICA (PTY) 1% HAFNERSTRASSE 36 A- OTHER VIAL,1.0X
LIMITED 8055 GRAZ AUSTRIA INFUSIONS 10.0X50.0
FRESENIUS KABI AB PLANT ML
UPPSALA-RAPSGATAN 7S- VIAL,1.0X
75174 UPPSALA SWEDEN 10.0X100.
0 ML VIAL
3823 NDA/MAL/H TIL HARLEYS ASTYMIN MULTI- MULTI- TIL HEALTH CARE-PLOT INDIA ORAL SOLID 1.0X5.0X3 11/29/2017
DP/8358 HEALTHCARE UGANDA FORTE INGREDIENT INGREDIEN 100,WEST,R- ORDINARY .0X10.0
PVT LTD LIMITED T 5,SOUTH;SRICITY CAPSULES CAPSULE
SEZ,CHERIVI,IRUHULAM,PS BLISTER
OT,SATYAVEDU
MANDAL,CHITOOR
DISTRICT-ANDRA
PRADESH-517588, INDIA
3824 NDA/MAL/H ABACUS ABACUS ASUNATE ARTESUNATE 120MG LINCOLN PARENTERAL INDIA PARENTERAL 1.0X120.0 11/29/2017
DP/8359 PARENTERAL PHARMA 120 LIMITED- 11, TRIMUL ORDINARY MG VIAL +
DRUGS (AFRICA) ESTATE, KHATRAJ, TAL. DRY VIALS 1*10 ML
LIMITED LIMITED KALOL, SODIUM
DIST. GANDHINAGAR, CHLORIDE
GUJARAT, INDIA. IN GLASS
AMPOULE
+ 1*2 ML
SODIUM
BICARBO
NATE IN
GLASS
3825 NDA/MAL/H İLKO İLAÇ CORE ACCESS IRBECOR IRBESARTAN 150MG + İLKO İLAÇ SANAYI VE TURKEY ORAL SOLID 1.0X2.0X1 11/29/2017
DP/8392 SANAYI VE LIMITED PLUS + 12.5MG TICARET A. Ş-3. ORGANIZE ORDINARY 4.0
TICARET A. Ş. 150MG/12. HYDROCHLOR SANAYI BÖLGESI KUDDUSI FILM- TABLET
5MG OTHIAZIDE CAD. 23. SOK. NO:1 COATED BLISTER
3826 NDA/MAL/H NATIONAL ANDYCO NACLOR CHLORAMPH 0.5% W/V NATIONAL HEALTHCARE NEPAL OPHTHALMI 1.0X10.0 11/29/2017
DP/8393 HEALTHCARE PHARMACY EYE DROPS ENICOL PVT. LTD.--WORKS: C DROPS ML
(UGANDA) LTD 10ML STERILE BLOCK BOTTLE
CHHATAPIPRA-3, BARA,
NEPAL
3827 NDA/MAL/H MACLEODS NORVIK RIFAMPICIN RIFAMPICIN + 75MG + MACLEODS INDIA ORAL SOLID 1.0X100.0 11/29/2017
DP/8394 PHARMACEUT ENTERPRISES 75 MG ISONIAZID + 50MG + PHARMACEUTICALS LTD., ORDINARY TABLET
ICALS LTD LIMITED ISONIAZID PYRAZINAMI 150MG NO. 25-27-PLOT NO. 25-26- SOLUBLE CONTAIN
50 MG AND DE 27, SURVEY NO.366, TABLETS ER,1.0X3.
PYRAZINA PREMIER INDUSTRIAL 0X28.0
MIDE 150 ESTATE ., DAMAN - TABLET
MG 396210, KACHIGAM, BLISTER,1.
DISPERSIBL DAMAN 0X24.0X28
E TABLETS .0 TABLET
BLISTER
3828 NDA/MAL/H MACLEODS NORVIK RIFAMPICIN RIFAMPICIN + 75MG + MACLEODS INDIA ORAL SOLID 1.0X100.0 11/29/2017
DP/8395 PHARMACEUT ENTERPRISES 75 MG ISONIAZID 50MG PHARMACEUTICALS LTD., ORDINARY TABLET
ICALS LTD LIMITED ISONIAZID NO. 25-27-PLOT NO. 25-26- SOLUBLE CONTAIN
50 MG 27, SURVEY NO.366, TABLETS ER,1.0X3.
DISPERSABL PREMIER INDUSTRIAL 0X28.0
E TABLETS ESTATE ., DAMAN - TABLET
396210, KACHIGAM, BLISTER
DAMAN
3829 NDA/MAL/H MARIE MARIE STOPES BACK-UP LEVONORGES 1.5MG ACME FORMULATION PVT INDIA ORAL SOLID 1.0X1.0 11/29/2017
DP/8396 STOPES UGANDA TREL LTD.- ROPAR ROAD ORDINARY TABLET
INTERNATION LIMITED NALAGARH DIST SOLAN FILM- BLISTER
AL (H.P) -174 101 COATED
TABLETS
DP/8407 PHARMACEUT ENTERPRISES LTD -CAMP ROAD, ORDINARY 0.0
ICALS LTD LIMITED SELAQUI – 248 197 TABLETS TABLET
DEHRADUN (UK) BLISTER
3831 NDA/MAL/H NAARI AG ECHO PENEM-N MEROPENEM 1000MG NITIN LIFE SCIENCES INDIA PARENTERAL 1.0X30.0 11/26/2019
DP/8408 PHARMACY (U) LIMITED.-RAMPUR ROAD, ORDINARY ML VIAL
LIMITED PAONTA SAHIB, SIRMOUR- DRY VIALS
173025, H.P,
3832 NDA/MAL/H SUPER MEDIC SUPER MEDIC KPANJEC PANTOPRAZO 40MG SAMRUDH INDIA PARENTERAL 1.0X10.0 11/26/2019
DP/8409 LTD. LTD LE SODIUM PHARMACEUTICALS PVT ORDINARY ML VIAL
LTD-J-174, J-168 & J-168/1, DRY VIALS
MIDC, TARAPUL, BOISAR,
DIST THANE-401506
3833 NDA/MAL/H MYLAN KIMSY MEDS AMOXICILLI AMOXICILLIN 1.2G MYLAN LABORATORIES INDIA PARENTERAL 1.0X20.0 1/13/2020
DP/8410 LABORATORIE LTD N& SODIUM + LTD-PLOT NO.11, 12 & 13, ORDINARY ML VIAL
S LIMITED POTASSIUM POTASSIUM INDORE SPECIAL DRY VIALS
CLAVULAN CLAVULANAT ECONOMIC ZONE,
ATE E PHARMA ZONE, PHASE II,
454775; DIST; DHAR;
MADHYA PRADESH;
3834 NDA/MAL/H LABORATORY HARLEYS RHEUMAC DICLOFENAC 1%W/W LABORATORY & ALLIED KENYA TOPICAL 1.0X20.0 11/29/2017
DP/8411 AND ALLIED UGANDA GEL LTD--PLOT NO. 209/ EXTERNAL G TUBE
LTD LIMITED 10349, OPP. SAMEER GELS AND
BUSINESS PARK, SOLS
MOMBASA ROAD P.O.
BOX 42875, GPO 00100,
NAIROBI, KENYA
3835 NDA/MAL/H MYLAN KIMSY MEDS ENOXAPARI ENOXAPARIN 40MG MYLAN LABORATORIES INDIA PARENTERAL 1.0X1.0 1/13/2020
DP/8415 LABORATORIE LTD N SODIUM SODIUM LTD-PLOT NO.11, 12 & 13, ORDINARY ML PRE-
S LIMITED INJECTION INDORE SPECIAL PRE-FILLED FILLED
ECONOMIC ZONE, SYRINGES SYRINGE
454775; DIST; DHAR;
MADHYA PRADESH;
3836 NDA/MAL/H MYLAN KIMSY MEDS ENOXAPARI ENOXAPARIN 60MG MYLAN LABORATORIES INDIA PARENTERAL 1.0X1.0 1/13/2020
DP/8416 LABORATORIE LTD N SODIUM SODIUM LTD-PLOT NO.11, 12 & 13, ORDINARY ML PRE-
S LIMITED INJECTION INDORE SPECIAL PRE-FILLED FILLED
ECONOMIC ZONE, SYRINGES SYRINGE
454775; DIST; DHAR;
MADHYA PRADESH;
3837 NDA/MAL/H UNOSOURCE ABACUS CLOPIDOW CLOPIDOGREL 75MG AKUMS DRUGS & INDIA ORAL SOLID 1.0X3.0X1 1/13/2020
DP/8418 PHARMA LTD. PHARMA EL 75 PHARMACEUTICALS LTD- ORDINARY 0.0
HARIDWAR-249403
3838 NDA/MAL/H LINCOLN METRO HAEMRICH FERRIC 50MG + LINCOLN PARENTERAL LTD- INDIA ORAL LIQUID 1.0X90.0 7/1/2017
DP/8424 PARENTERAL PHARMACEUTIC AMMONIUM 0.55MG 11, TRIMUL ESTATE ORDINARY ML
LIMITED ALS LIMITED CITRATE+ +2.4MG + KHATRAJ DISI. SYRUPS BOTTLE
FOLIC 1.2MG GANDHINAGAR-38272,
ACID+PYRIDO +11MG GUJARAT
XINE HCL + /5ML
THIAMINE
HCL +
NICOTINAMI
DE
3839 NDA/MAL/H PHARCO WIDE DECLOPHE DICLOFENAC 100MG PHARCO EGYPT RECTAL 1.0X5.0 7/1/2017
DP/8432 PHARMACEUT SPECTRUM N SODIUM PHARMACEUTICALS-KILO SYSTEMIC SUPPOSIT
ICALS ENTERPRISES 31 ALEXANDRIA-CAIRO ADULT ORY STRIP
(U) LIMITED DESERT ROAD AMRIYA SUPPOSITORI
ALEXANDRIA ES
3840 NDA/MAL/H DAWA SUPER MEDIC DACINAZOL MICONAZOLE 2%W/W DAWA LTD-BABA DOGO KENYA TOPICAL 1.0X15.0 7/1/2009
DP/8434 LIMITED LTD E NITRATE ROAD RUARAKA EXTERNAL G TUBE
CREAMS
3841 NDA/MAL/H BLUE CROSS STAR EKON-D CETIRIZINE 10 MG BLUE CROSS INDIA ORAL SOLID 1.0X10.0X 7/1/2001
DP/8443 LABORATORIE PHARMACEUTIC TABLETS LABORATORIES LTD-L-17, ORDINARY 10.0
S LTD ALS LTD VERNA INDUSTRIAL TABLETS TABLET
ESTATE,VERNA GOA- STRIP,1.0X
403722 10.0X12.0
TABLET
STRIP
3842 NDA/MAL/H THEON AIVEEN (U) THEOMOX- AMOXICILLIN 500 MG THEON INDIA ORAL SOLID 1.0X10.0X 1/31/2018
DP/8468 PHARMACEUT LIMITED 500 PHARMACEUTICALS ORDINARY 10.0
ICALS LIMITED.- CAPSULES CAPSULE
LIMITTED VILLAGE SAINI MAJRA, BLISTER
TEHSIL NALAGARH, DISTT.
SOLAN, HIMACHAL
PRADESH 174 101 INDIA
3843 NDA/MAL/H WOCKHARDT ABACUS GLARITUS INSULIN 100IU/ML WOCKHARDT LIMITED -- INDIA PARENTERAL 1.0X3.0 1/31/2018
DP/8477 LTD PHARMA 100IU/ML GLARGINE WOCKHARDT BIOTECH ORDINARY ML
(AFRICA) PARK, H14/2, M.I.D.C, CARTRIDGES CARTRIDG
LIMITED WALUJ, AURANGABAD E
431136 MAHARASHTRA
INDIA
3844 NDA/MAL/H LINCOLN METRO PARACETA PARACETAM 150MG/ML LINCOLN PARENTERAL LTD INDIA PARENTERAL 1.0X10.0X 1/31/2018
DP/8481 PARENTERAL PHARMACEUTIC MOL BP OL -11 TRIUL ESTATE ORDINARY 2.0 ML
LIMITED ALS LIMITED INJECTION KHATRAJ TAL KALOL DIST AMPOULES AMPOULE
GANDHINAGAR GUJARAT
3845 NDA/MAL/H SANDOZ SURGIPHARM GLIMEPIRID GLIMEPIRIDE 2MG LEK S.A--U1, PODLIPIE 16, POLAND ORAL SOLID 1.0X9.0X1 1/31/2018
DP/8483 KENYA C/O (U) LIMITED E 2MG 95-0140 STRYKOW ORDINARY 0.0
NOVARTIS POLAND TABLETS TABLET
PHARMA BLISTER
SERVICES INC
3846 NDA/MAL/H MEDOCHEMIE BOOTS AVERNOL CARVEDILOL 25MG MEDOCHEMIE LTD-1-10 CYPRUS ORAL SOLID 1.0X3.0X1 1/31/2018
DP/8484 LTD PHARMACEUTIC CONSTANTINOUPOLEOS ORDINARY 0.0
ALS LIMITED TREET 3011 LIMASSOL TABLETS TABLET
BLISTER
3847 NDA/MAL/H CACHET ASTRA PHARMA TRIAXON CEFIXIME 400MG ALKEM LABORATORIES INDIA ORAL SOLID 1.0X10.0 1/31/2018
DP/8485 PHARMACEUT (U) LIMITED LTD .-VILLAGE THANA, ORDINARY TABLET
ICALS PVT BADDI, TEHSIL- COATED BLISTER
LIMITED NALAGARH, DISTT-SOLAN, TABLETS
(HP), INDIA-173205
3848 NDA/MAL/H ZIM GITTOES CEFRAZ 200 CEFIXIME 200MG ZIM LABORATORIES INDIA ORAL SOLID 1.0X1.0X1 1/31/2018
DP/8488 LABORATORIE PHARMACEUTIC TRIHYDRATE LIMITED-B-21122, MIDC ORDINARY 0.0
S LTD ALS LIMITED AREA, CAPSULES CAPSULE
KALMESHWAR -441 501, BLISTER
DIST. NAGPUR,INDIA.
3849 NDA/MAL/H SWISS SHREEJI MEDOL TRAMADOL 100 MG / 2 SWISS PARENTERALS LTD- INDIA PARENTERAL 1.0X2.0 1/31/2018
DP/8489 PARENTERALS PHARMACEUTIC HYDROCHLOR ML 809 KERALA IND ESTATE ORDINARY ML
LTD ALS LIMITED IDE GIDC NEAR BAVLA DIST AMPOULES AMPOULE
AHMEDABAD 382220 ,1.0X5.0X2
GUJARAT INDIA .0 ML
AMPOULE
3850 NDA/MAL/H MERCK (PTY) UNITED CETROTIDE CETRORELIX 0.25MG ABBOTT BIOLOGICALS B.V FRANCE PARENTERAL 1.0X1.0 1/31/2018
DP/8491 LTD HEALTHCARE 0.25MG VEERWEG -12,NL-8121 AA ORDINARY VIAL
DISTRIBUTORS OLST COMBINATI CARTON,1
LTD THE NETHERLANDS ON PACK .0X1.0
PIERRE FABRE VIALS PREFILLED
MEDICAMENT - SYRINGE
AQUITAINE PHARM CARTON
INTERNATIONAL SITE 1
3851 NDA/MAL/H GILEAD MEDICAL DESCOVY EMTRICITABI 200MG + PATHEON INC.--TORONTO CANADA ORAL SOLID 1.0X30.0 1/31/2018
DP/8493 SCIENCE INC ACCESS 200MG/25 NE/TENOFOV 25 MG REGIONAL OPERATIONS ORDINARY TABLET
(UGANDA) MG IR 2100, SYNTEX COURT, TABLETS BOTTLE
LIMITED ALAFENAMID MISSISSAUGA, ONTARIO,
E CANADA, L5N 7K9
ROTTENDORF PHARMA
GMBH-OSTENFELDER
STRAßE 51-61,59320
ENNIGERLOH,GERMANY
3852 NDA/MAL/H KOTRA ABACUS VAXCEL CEFOPERAZO 500MG + KOTRA PHARMA (M) MALAYSIA PARENTERAL 1.0X1.0 G 1/31/2018
DP/8494 PHARMA (M) PHARMA CEFOBACTA NE 500MG SDN.BHD,-1,2 & 3 JALAN ORDINARY VIAL
SDN,BHD (AFRICA) M SODIUM+SUL TTC 12 CHENG DRY VIALS
LIMITED BACTAM INDUSTRIAL ESTATE 75250
SODIUM MELAKA
3853 NDA/MAL/H CACHET ASTRA PHARMA CACEF 50 CEFPODOXIM 50MG / ALKEM LABORATORIES INDIA ORAL LIQUID 1.0X30.0 1/31/2018
DP/8495 PHARMACEUT (U) LIMITED E PROXETIL 5ML LTD.-VILLAGE THANA, ORDINARY ML
ICALS USP BADDI, DISTT. DRY BOTTLE
PRIVATE SOLAN,HIMACHAL SUSPENSION
LIMITED PRADESH 173205 INDIA. S/SYRUPS/D
ROPS
3854 NDA/MAL/H TWENTY SWASTIK TRYOXIM CEFUROXIME 500 MG TWENTY FIRST CENTURY INDIA ORAL SOLID 1.0X3.0X1 1/31/2018
DP/8497 FIRST PHARMACEUTIC 500 AXETIL PHARMACEUTICALS ORDINARY 0.0
CENTURY AL LTD PVT.LTD - -UNIT II, TABLETS TABLET
PHARMACEUT KHASRA NO: 282, NALHERI BLISTER
ICALS PVT.LTD DEHVIRAN,
NALHERA
ANANTPUR,PUHANA -
IQBALPUR ROAD,
HARIDWAR,
UTTARAKHAND
3855 NDA/MAL/H YELURI ESCORTS SOLOCEF CEFTRIAXONE 1000MG YELURI FORMULATIONS INDIA PARENTERAL 1.0X10.0 12/11/2018
DP/8499 FORMULATIO PHARMACEUTIC 1000 MG SODIUM PVT. LTD-SY. NO. 296 / 7 / ORDINARY ML VIAL
NS PVT LTD ALS LIMITED 6 DRY VIALS
IDA BOLLARAM,MEDAK
DIST.502325,
TELANGANA,INDIA.
3856 NDA/MAL/H MEDREICH SURGIPHARM FLEMING AMOXICILLIN 400MG/5 MEDREICH STERILAB LTD- INDIA ORAL LIQUID 1.0X70.0 7/1/2009
DP/8502 PLC (U) LIMITED + POTASSIUM ML + 12TH MILE, OLD MADRAS ORDINARY ML
CLAVULANAT 57MG/5ML ROAD, VIRGONAGOR, DRY BOTTLE
E BANGALORE 560049, SUSPENSION
INDIA S/SYRUPS/D
ROPS
3857 NDA/MAL/H MYLAN KIMSY MEDS LEDVIR LEDIPASVIR + 90MG + MYLAN LABORATORIES INDIA ORAL SOLID 1.0X28.0 11/29/2017
DP/8504 LABORATORIE LTD SOFOSBUVIR 400MG LIMITED-F- 4 & F-12, ORDINARY TABLET
S LIMITED MIDC, MALEGAON, FILM- BOTTLE
SINNAR, NASHIK -422 113 COATED
MAHARASHTRA, INDIA. TABLETS
3858 NDA/MAL/H PLANET PLANET DAYPENAM MEROPENEM 500MG SWISS PARENTERALS LTD- INDIA PARENTERAL 1.0X10.0X 7/1/2017
DP/8522 PHARMACEUT PHARMACEUTIC 809 KERALA IND ESTATE ORDINARY 500.0 MG
ICALS ALS UGANDA GIDC NEAR BAVLA DIST DRY VIALS VIAL
UGANDA LTD LTD AHMEDABAD 382220
GUJARAT INDIA
3859 NDA/MAL/H UNOSOURCE ABACUS FINAMAX FINASTERIDE 5MG AKUMS DRUGS & INDIA ORAL SOLID 1.0X10.0X 1/13/2020
DP/8564 PHARMA LTD. PHARMA PHARMACEUTICALS LTD- ORDINARY 10.0
HARIDWAR-249403
3860 NDA/MAL/H SQUARE GAMA SULTOLIN SALBUTAMOL 100MCG/P SQUARE BANGLADESH LUNG 1.0X200.0 11/29/2019
DP/8565 PHARMACEUT PHARMACEUTIC HFA SULFATE UFF PHARMACEUTICALS ADMINISTRA DOSE
ICALS LTD ALS (U) LIMITED INHALER LIMITED - DHAKA UNIT- TION CANNISTE
KALIAKOIR GAZIPUR METERED- R
DOSE
INHALER
3861 NDA/MAL/H UNOSOURCE ABACUS AZINOWEL AZITHROMYCI 200MG/5 AKUMS DRUGS & INDIA ORAL LIQUID 1.0X15.0 11/29/2019
DP/8566 PHARMA LTD. PHARMA N ML PHARMACEUTICALS LTD- ORDINARY ML
(AFRICA) PLANT II, PLOT NO. 22, SUSPENSION BOTTLE
LIMITED SECTOR- 6A, IIE, SIDCUL, S
RANIPUR, DISTT.:
HARIDWAR,
UTTARAKHAND
3862 NDA/MAL/H DAFRA LABOREX TERBINOL® TERBINAFINE 1%W/W NOBEL İLAÇ SAN. VE TIC. TURKEY TOPICAL 1.0X15.0 11/26/2019
DP/8569 PHARMA UGANDA HYDROCHLOR A.Ş-SANCAKLAR, DÜZCE, EXTERNAL G TUBE
GMBH LIMITED IDE 81100 CREAMS
3863 NDA/MAL/H MAVID MAVID KOFLIN CHLOPHENIR 2MG MAVID PHARMACEUTICAL UGANDA ORAL LIQUID 1.0X100.0 7/1/2005
DP/8602 PHARMACEUT PHARMACEUTIC COUGH FLU AMINE INDUSTRIES LIMITED-PLOT ORDINARY ML
ICALS LIMITED AL INDUSTRIES LINCTUS 490 BIRONGO, KITIIKO SYRUPS BOTTLE
LIMITED
3864 NDA/MAL/H MAVID MAVID MAGNESIU SODIUM 250 MG + MAVID PHARMACEUTICAL UGANDA ORAL LIQUID 1.0X200.0 7/1/2005
DP/8603 PHARMACEUT PHARMACEUTIC M BICARBONAT 250 MG + INDUSTRIES LIMITED-PLOT ORDINARY ML
ICAL AL INDUSTRIES TRISILICATE E + LIGHT 250 MG 490 BIRONGO, KITIIKO SUSPENSION BOTTLE
INDUSTRIES LIMITED SUSPENSIO MAGNESIUM S
LIMITED N CARBONATE
+
MAGNESIUM
3865 NDA/MAL/H MAVID MAVID PYODINE POVIDINE- 10 %W/V MAVID PHARMACEUTICAL UGANDA TOPICAL 1.0X60.0 7/1/2005
DP/8604 PHARMACEUT PHARMACEUTIC IODINE INDUSTRIES LIMITED-PLOT EXTERNAL ML
ICAL AL INDUSTRIES 490 BIRONGO, KITIIKO LIQUIDS BOTTLE
INDUSTRIES LIMITED
LIMITED
3866 NDA/MAL/H MAVID MAVID HYDROGEN HYDROGEN 6 %W/V MAVID PHARMACEUTICAL UGANDA TOPICAL 1.0X250.0 7/1/2005
DP/8605 PHARMACEUT PHARMACEUTIC PEROXIDE PEROXIDE INDUSTRIES LIMITED-PLOT EXTERNAL ML
INDUSTRIES LIMITED
LIMITED
3867 NDA/MAL/H MAVID MAVID DIPHEX DIPHENHYDR 0.014 MG / MAVID PHARMACEUTICAL UGANDA ORAL LIQUID 1.0X100.0 7/1/2005
DP/8606 PHARMACEUT PHARMACEUTIC COUGH AMINE 5 ML + INDUSTRIES LIMITED-PLOT ORDINARY ML
ICAL AL INDUSTRIES EXPECTORA HYDROCHLOR 0.057 MG / 490 BIRONGO, KITIIKO SYRUPS BOTTLE
INDUSTRIES LIMITED NT IDE + SODIUM 5 ML +
LIMITED CITRATE + 0.135 MG /
AMMONIUM 5 ML
CHLORIDE
3868 NDA/MAL/H MAVID MAVID SURGICAL MULT- N/A MAVID PHARMACEUTICAL UGANDA TOPICAL 1.0X100.0 7/1/2005
DP/8611 PHARMACEUT PHARMACEUTIC SPIRIT INGREDIENT INDUSTRIES LIMITED-PLOT EXTERNAL ML
INDUSTRIES LIMITED
LIMITED
3869 NDA/MAL/H MAVID MAVID CALAMINE CALAMINE + 0.75 MG / MAVID PHARMACEUTICAL UGANDA TOPICAL 1.0X100.0 7/1/2005
DP/8615 PHARMACEUT PHARMACEUTIC LOTION ZINC OXIDE 5 ML + INDUSTRIES LIMITED-PLOT EXTERNAL ML
ICAL AL INDUSTRIES 0.25 MG / 490 BIRONGO, KITIIKO SUSPENSION BOTTLE
INDUSTRIES LIMITED 5 ML S
LIMITED
3870 NDA/MAL/H MAVID MAVID MAVID'S CHLORHEXIDI 0.015 G / 5 MAVID PHARMACEUTICAL UGANDA TOPICAL 1.0X125.0 7/1/2007
DP/8617 PHARMACEUT PHARMACEUTIC KEVLON NE ML +0.15 G INDUSTRIES LIMITED-PLOT EXTERNAL ML
ICAL AL INDUSTRIES GLUCONATE / 5 ML 490 BIRONGO, KITIIKO LIQUIDS BOTTLE
INDUSTRIES LIMITED 20% +
LIMITED CETRIMIDE
3871 NDA/MAL/H CADILA ESCORTS TELI H TELMISARTA 40MG + CADILA INDIA ORAL SOLID 1.0X3.0X1 3/28/2018
DP/8641 PHARMACEUT PHARMACEUTIC N+ 12.5MG PHARMACEUTICALS ORDINARY 0.0
ICALS LIMITED ALS LIMITED HYDROCHLOR LIMITED-1389, TRASAD LAYERED TABLET
OTHIAZIDE ROAD, DHOLKA- 382225, TABLETS BLISTER
STATE, INDIA
3872 NDA/MAL/H EGYPHAR WIDE LORAFAST DESLORATADI 2.5MG/5M EGYPTIAN EGYPT ORAL LIQUID 1.0X100.0 1/13/2020
DP/8642 SPECTRUM NE L INTERNATIONAL ORDINARY ML
ENTERPRISES PHARMACEUTICAL SYRUPS BOTTLE
(U) LIMITED INDUSTRIES CO.(EIPICO)-
10TH RAMADHAN CITY
INDUSTRIAL AREA-B1 , P.
O. BOX 149 TENTH,
EGYPT
3873 NDA/MAL/H SWISS SHREEJI ARTESUNA ARTESUNATE 60MG BLISS INDAS LIFESCIENCE INDIA PARENTERAL 1.0X1.0X6 3/28/2018
DP/8643 PARENTERALS PHARMACEUTIC TE 60MG P. LTD..-PLOT 73-76, ORDINARY 0.0 MG
PVT LTD ALS LIMITED SILVER INDUSTRIAL DRY VIALS VIAL +
ESTATE, BHIMPORE, 1*1*5ML
DAMAN AMPOULE
OF
0.9%W/V
NACL +
1*1*1ML
AMPOULE
OF
5%W/V
3874 NDA/MAL/H CACHET ASTRA PHARMA LOOBID OFLOXACIN + 50MG + CACHET INDIA ORAL LIQUID 1.0X1.0X3 3/28/2018
DP/8644 PHARMACEUT (U) LIMITED SUSPENSIO ORNIDAZOLE 125MG / PHARMACEUTICALS PVT ORDINARY 0.0 ML
ICALS PVT LTD N 5ML LTD-VILLAGE AND POST SUSPENSION BOTTLE
THANA BADDI TEHSIL S
NALAGARH SOLAN
DISTRICT HIMACHAL
PRADESH 173 205
3875 NDA/MAL/H EGYPHAR WIDE MODAZAR LOSARTAN + 100MG + EGYPTIAN EGYPT ORAL SOLID 1.0X2.0X4 1/13/2020
DP/8645 SPECTRUM HYDROCHLOR 25MG INTERNATIONAL ORDINARY .0 TABLET
ENTERPRISES OTHIAZIDE PHARMACEUTICAL TABLETS STRIP
(U) LIMITED INDUSTRIES CO.(EIPICO)-
10TH RAMADHAN CITY
O. BOX 149 TENTH,
EGYPT
3876 NDA/MAL/H EGYPHAR WIDE ZISROCIN AZITHROMYCI 100MG/5 EGYPTIAN EGYPT ORAL LIQUID 1.0X30.0 1/13/2020
DP/8647 SPECTRUM N DIHYDRATE ML INTERNATIONAL ORDINARY ML
ENTERPRISES PHARMACEUTICAL SUSPENSION BOTTLE
(U) LIMITED INDUSTRIES CO.(EIPICO)- S
10TH RAMADHAN CITY
O. BOX 149 TENTH,
EGYPT
3877 NDA/MAL/H UNOSOURCE ABACUS UNODEX TERBUTALINE 2.5MG + AKUMS DRUGS & INDIA ORAL LIQUID 1.0X1.0X1 3/28/2018
DP/8648 PHARMA LTD. PHARMA PLUS SULPHATE + 8MG + PHARMACEUTICALS LTD- ORDINARY 00.0 ML
(AFRICA) BROMHEXINE 100MG PLANT II-PLOT NO.22, SYRUPS BOTTLE
LIMITED HYDROCHLOR SECTOR 6-A, IIE, SIDCUL,
IDE + RANIPUR,DISTRICT:
GUAIFENESIN HARIDWAR 249 403, INDIA
3878 NDA/MAL/H INJECTCARE MATRIX (U) LTD CEFCARE CEFTRIAXONE 1G INJECTCARE PARENTERALS INDIA PARENTERAL 1.0X10.0 1/31/2018
DP/8649 PARENTERALS SODIUM PVT. LTD.-PLOT130 ORDINARY ML VIAL
PVT. LTD SILVASSA ROAD GIDC VAPI VIALS
396195 GUJARAT
3879 NDA/MAL/H İLKO İLAÇ CORE ACCESS CEFDIA CEFIXIME 400MG NOBEL İLAÇ SAN. VE TIC. TURKEY ORAL SOLID 1.0X1.0X5 3/28/2018
DP/8650 SANAYI VE LIMITED 400MG TRIHYDRATE A.Ş.-81100 ORDINARY .0 TABLET
TICARET A. Ş. SANCAKLAR, DÜZCE- FILM- BLISTER,1.
TURKEY COATED 0X2.0X1.0
TABLETS X5.0
TABLET
BLISTER
3880 NDA/MAL/H PSA ROYAL PHARMA LEFLOXIN LEVOFLOXACI 500MG ZIM LABORATORIES LTD-B- INDIA ORAL SOLID 1.0X1.0X1 3/28/2018
DP/8653 INTERNATION 2011 LIMITED 500 N 21/22, M.I.D.C. AREA, ORDINARY 0.0
AL (EXPORT HEMIHYDRAT KALMESHWAR – 441501, FILM- TABLET
DIVISION OF E DIST. NAGPUR, COATED BLISTER
PSA MAHARASHTRA, TABLETS
CHEMICALS
AND
PHARMACEUT
ICALS PVT.
LTD)
3881 NDA/MAL/H MERCK (PTY) UNITED GLUCOPHA METFORMIN 1000MG MERCK KGAA-PHARMA GERMANY ORAL SOLID 1.0X4.0X1 3/28/2018
DP/8655 LTD HEALTHCARE GE XR HYDROCHLOR PRODUCTION RETARD 5.0
DISTRIBUTORS 1000MG IDE DARMSTADT - TABLETS TABLET
LTD FRANKFURTER STRABE BLISTER,1.
250, D-64293, 0X6.0X10.
DARMSTADT MERCK 0 TABLET
SANTÉ S.A.S.-2 RUE DU BLISTER
PRESSOIR VERT
45400 SEMOY
FRANCE
3882 NDA/MAL/H SANDOZ SURGIPHARM METFORMI METFORMIN 1000MG LEK S.A.-16 PODLIPIE STR. POLAND ORAL SOLID 1.0X4.0X1 3/28/2018
DP/8658 GMBH, (U) LIMITED N 1000MG HYDROCHLOR 95-010 STRYKOW ORDINARY 5.0
KUNDL IDE FILM- TABLET
COATED BLISTER
TABLETS
3883 NDA/MAL/H SANDOZ SURGIPHARM METFORMI METFORMIN 500MG LEK S.A.-16 PODLIPIE STR. POLAND ORAL SOLID 1.0X6.0X1 7/1/2010
DP/8659 GMBH, (U) LIMITED N 500MG HYDROCHLOR 95-010 STRYKOW ORDINARY 0.0
KUNDL IDE FILM- TABLET
COATED BLISTER
TABLETS
3884 NDA/MAL/H GILEAD MEDICAL VEMLIDY TENOFOVIR 25MG PATHEON INC.--TORONTO CANADA ORAL SOLID 1.0X1.0X3 3/28/2018
DP/8660 SCIENCE INC ACCESS ALAFENAMID REGIONAL OPERATIONS ORDINARY 0.0
(UGANDA) E 2100, SYNTEX COURT, FILM- TABLET
LIMITED MISSISSAUGA, ONTARIO, COATED BOTTLE
CANADA, L5N 7K9 TABLETS
3885 NDA/MAL/H AUROBINDO GITTOES DOLUTEGR DOLUTEGRAV 50MG AUROBINDO PHARMA LTD INDIA ORAL SOLID 1.0X1.0X3 3/28/2018
DP/8661 PHARMA LTD PHARMACEUTIC AVIR IR SODIUM UNIT VII (SEZ) APIIC-PLOT ORDINARY 0.0
ALS LIMITED TABLETS NO. S1 SURVEY NO. FILM- TABLET
50MG 411,425,434,435 & 458 COATED BOTTLE
GREEN INDUSTRIAL PARK TABLETS
POLEPALLY VILLAGE
MAHABOOBNAGAR
DISTRICT ANDHRA
PRADESH
3886 NDA/MAL/H CACHET ASTRA PHARMA PAMAGIN-C CETIRIZINE 5.0 MG CACHET INDIA ORAL SOLID 1.0X1.0X1 3/28/2018
DP/8665 PHARMACEUT (U) LIMITED HYDROCHLOR +15 MG + PHARMACEUTICALS PVT ORDINARY 0.0
ICALS PVT LTD IDE + 500 MG + LTD-VILLAGE AND POST FILM- TABLET
DEXTROMET 5 MG + 7.5 THANA BADDI TEHSIL COATED BLISTER
HORPHAN MG NALAGARH SOLAN TABLETS
HYDROBROM DISTRICT HIMACHAL
IDE + PRADESH 173 205
ACETAMINOP
HEN +
PHENYLEPHRI
NE
HYDROCHLOR
3887 NDA/MAL/H TENTH OF GAMA MEGAFEN IBUPROFEN 100MG/5 TENTH OF RAMADAN FOR EGYPT ORAL LIQUID 1.0X1.0X1 11/26/2019
DP/8684 RAMADAN PHARMACEUTIC N ML PHARMACEUTICAL ORDINARY 00.0 ML
FOR ALS (U) LIMITED INDUSTRIES & SUSPENSION BOTTLE
PHARMACEUT DIAGNOSTIC REAGENTS S
ICALS (RAMEDA)-SECOND
INDUSTRIES INDUSTRIAL ZONE, PLOT
AND NO.5 SIXTH OF OCTOBER-
DIAGNOSTICS EGYPT
REAGENTS(RA
MEDA)
3888 NDA/MAL/H MSN ABACUS RANCV 500 RANOLAZINE 500 MG MSN LABORATORIES PVT. INDIA ORAL SOLID 1.0X3.0X1 5/30/2018
DP/8685 LABORATORIE PHARMA LIMITED-PLOT NO. 42 RETARD 0.0
S PRIVATE (AFRICA) ANRICH INDUSTRIAL FILM- TABLET
LIMITED LIMITED ESTATE, BOLLARAM COATED BLISTER
MEDAK DISTRICT TABLETS
PIN CODE 502 325
3889 NDA/MAL/H MYLAN KIMSY MEDS DURART DARUNAVIR 800 MG MYLAN LABORATORIES INDIA ORAL SOLID 1.0X30.0 5/30/2018
DP/8689 LABORATORIE LTD 800 LTD --H-12 & H-13, MIDC, ORDINARY TABLET
S LIMITED WALUJ,AURANGABAD- FILM- BOTTLE
431136 MAHARASHTRA, COATED
INDIA TABLETS
3890 NDA/MAL/H CIPLA LTD QUALITY ARTESUNA ARTESUNATE 100MG CIPLA LIMITED.,-PLOT INDIA RECTAL 1.0X1.0X2 9/26/2018
DP/8690 CHEMICALS LTD - TE NO.D-7 MIDC INDUSTRIAL SYSTEMIC .0 BLISTER
HUMAN SUPPOSITO AREA, SUPPOSITORI CARTON
RIES KURKUMBH,DIST:PUNE ES
100MG 413802,INDIA
3891 NDA/MAL/H REMEDICA GOODMAN QUETRA LEVETIRACET 1000MG REMEDICA LTD.- CYPRUS ORAL SOLID 1.0X10.0X 5/30/2018
DP/8691 LTD INTERNATIONAL 1000 AM AHARNON STREET, ORDINARY 10.0
LTD LIMASSOL INDUSTRIAL FILM- TABLET
ESTATE,3056 LIMASSOL COATED BLISTER
CYPRUS TABLETS
3892 NDA/MAL/H GOODMAN GOODMAN PARAFUSIV PARACETAM 10 MG/ML S.M FARMACEUTICI SRL- ITALY PARENTERAL 1.0X50.0 5/30/2018
DP/8692 INTERNATION INTERNATIONAL OL ZONA INDUSTRIALE, ORDINARY ML
AL (U) LTD LTD 85050 TITO-POTENZA INFUSION VIAL,1.0X
(PZ) ITALY VIALS/BOTTL 100.0 ML
ES VIAL
3893 NDA/MAL/H REMEDICA GOODMAN QUETRA LEVETIRACET 100 REMEDICA LTD.- CYPRUS ORAL LIQUID 1.0X300.0 5/30/2018
DP/8693 LTD INTERNATIONAL 100MG/ML AM MG/ML AHARNON STREET, ORDINARY ML
LTD LIMASSOL INDUSTRIAL LIQUIDS BOTTLE
ESTATE,3056 LIMASSOL
CYPRUS
3894 NDA/MAL/H MERCK (PTY) UNITED ERBITUX CETUXIMAB 5MG/ML BOEHRINGER INGELHEIM GERMANY PARENTERAL 1.0X1.0X2
DP/8694 LTD HEALTHCARE PHARMA GMBH & CO. KG - ORDINARY 0.0 ML
DISTRIBUTORS -BIRKENDORFER STRASSE INFUSION VIAL
LTD 65, 88397, BIBERACH AN VIALS/BOTTL
DER RISS, GERMANY. ES
3895 NDA/MAL/H PHARCO WIDE BABY COL SIMETICONE 40MG/0.6 PHARCO EGYPT ORAL LIQUID 1.0X1.0X1 5/30/2018
DP/8696 PHARMACEUT SPECTRUM ML PHARMACEUTICALS-KILO ORDINARY 5.0 ML
ICALS ENTERPRISES 31 ALEXANDRIA-CAIRO EMULSIONS BOTTLE
(U) LIMITED DESERT ROAD AMRIYA
ALEXANDRIA
3896 NDA/MAL/H ZHUHAI SWASTIK KIN-CEF CEFTRIAXONE 1G ZHUHAI KINHOO CHINA PARENTERAL 1.0X1.0 G 8/28/2019
DP/8698 KINHOO PHARMACEUTIC SODIUM PHARMACEUTICAL CO., ORDINARY VIAL
PHARMACEUT AL LTD LTD.-BIO-INDUSTRY ZONE, DRY VIALS
ICAL CO., LTD GOLDEN COAST, ZHUHAI,
GUANGDONG, CHINA
3897 NDA/MAL/H REMEDICA GOODMAN ACETAZOLA ACETAZOLAM 250 MG REMEDICA LTD.- CYPRUS ORAL SOLID 1.0X3.0X1 5/30/2018
DP/8699 LTD INTERNATIONAL MIDE IDE AHARNON STREET, ORDINARY 0.0
ESTATE,3056 LIMASSOL BLISTER
CYPRUS
3898 NDA/MAL/H CADILA KARURI ISONIAZID ISONIAZID 300 MG CADILA INDIA ORAL SOLID 1.0X24.0X 7/1/2010
STATE, INDIA
3899 NDA/MAL/H TENTH OF GAMA ORDESCA DESLORATADI 5MG TENTH OF RAMADAN FOR EGYPT ORAL SOLID 1.0X3.0X1 11/26/2019
DP/8768 RAMADAN PHARMACEUTIC NE PHARMACEUTICAL ORDINARY 0.0
FOR ALS (U) LIMITED INDUSTRIES & FILM- TABLET
PHARMACEUT DIAGNOSTIC REAGENTS COATED BLISTER
ICALS (RAMEDA)-SECOND TABLETS
DIAGNOSTICS EGYPT
REAGENTS(RA
MEDA)
3900 NDA/MAL/H I CARE AIVEEN (U) AIVCEF-250 CEFUROXIME 250MG ASSOCIATED BIOTECH- INDIA ORAL SOLID 1.0X1.0X1 11/26/2019
DP/8778 PHARMA LIMITED AXETIL KRISHANPURA, P. O ORDINARY 0.0
LIMITED GURUMAJRA, BADDI, DIST. TABLETS TABLET
SOLAN BLISTER
3901 NDA/MAL/H M/S HETERO AIVEEN (U) STATINOR ROSUVASTATI 20MG HETERO LABS LIMITED INDIA ORAL SOLID 1.0X3.0X1 5/29/2019
DP/8779 LABS LIMITED LIMITED 20 N UNIT V-TSIIC ORDINARY 0.0
FORMULATION SEZ, S.NO FILM- TABLET
439, 440, 441 & 458 COATED BLISTER
POLEPALLY VILLAGE, TABLETS
JADCHERLA MANDAL,
MAHABOOB NAGAR (DIST)
–509301, TELANGANA
INDIA
3902 NDA/MAL/H HETERO AIVEEN (U) STATINOR ROSUVASTATI 10 MG HETERO LABS LIMITED INDIA ORAL SOLID 1.0X3.0X1 3/27/2019
DP/8780 DRUGS LTD LIMITED 10 N CALCIUM UNIT V-TSIIC ORDINARY 0.0
439, 440, 441 & 458 COATED BLISTER
JADCHERLA MANDAL,
INDIA
3903 NDA/MAL/H I CARE AIVEEN (U) AIVXIM-400 CEFIXIME 400MG ASSOCIATED BIOTECH- INDIA ORAL SOLID 1.0X1.0X6 11/26/2019
DP/8781 PHARMA LIMITED KRISHANPURA, P. O ORDINARY .0 TABLET
LIMITED GURUMAJRA, BADDI, DIST. TABLETS BLISTER
SOLAN
3904 NDA/MAL/H HETERO LABS AIVEEN (U) STATINOR 5 ROSUVASTATI 5MG HETERO LABS LIMITED INDIA ORAL SOLID 1.0X3.0X1 11/7/2018
DP/8782 LTD LIMITED N UNIT V-TSIIC ORDINARY 0.0
439, 440, 441 & 458 COATED BLISTER
JADCHERLA MANDAL,
INDIA
3905 NDA/MAL/H I CARE AIVEEN (U) AIVCLAV- AMOXICILLIN 250MG + MEDICEF PHARMA-NO. 28, INDIA ORAL SOLID 1.0X2.0X7 11/26/2019
DP/8783 PHARMA LIMITED 375 + 125MG PHASE 1, EPIP, ORDINARY .0 TABLET
LIMITED CLAVULANIC JHARRMAJRI, BADDI, DIST TABLETS BLISTER
ACID SOLAN (HP)
3906 NDA/MAL/H I CARE AIVEEN (U) AIVCEF-500 CEFUROXIME 500MG ASSOCIATED BIOTECH- INDIA ORAL SOLID 1.0X1.0X1 11/26/2019
DP/8784 PHARMA LIMITED AXETIL KRISHANPURA, P. O ORDINARY 0.0
SOLAN BLISTER
3907 NDA/MAL/H I CARE AIVEEN (U) AIVCEF CEFUROXIME 125MG/5 ASSOCIATED BIOTECH- INDIA ORAL LIQUID 1.0X60.0 11/26/2019
DP/8785 PHARMA LIMITED SUSPENSIO AXETIL ML KRISHANPURA, P. O ORDINARY ML
LIMITED N GURUMAJRA, BADDI, DIST. DRY BOTTLE
SOLAN SUSPENSION
S/SYRUPS/D
ROPS
3908 NDA/MAL/H I CARE AIVEEN (U) AIVXIM CEFIXIME 100MG ASSOCIATED BIOTECH- INDIA ORAL SOLID 1.0X1.0X1 11/26/2019
DP/8786 PHARMA LIMITED TRIHYDRATE KRISHANPURA, P. O ORDINARY 0.0
SOLAN BLISTER
3909 NDA/MAL/H I CARE AIVEEN (U) AIVXIM-200 CEFIXIME 200MG ASSOCIATED BIOTECH- INDIA ORAL SOLID 1.0X1.0X1 11/26/2019
DP/8787 PHARMA LIMITED KRISHANPURA, P. O ORDINARY 0.0
SOLAN BLISTER
3910 NDA/MAL/H I CARE AIVEEN (U) AIVPOD- CEFPODOXIM 200MG ASSOCIATED BIOTECH- INDIA ORAL SOLID 1.0X1.0X1 11/26/2019
DP/8788 PHARMA LIMITED 200 E PROXETIL KRISHANPURA, P. O ORDINARY 0.0
SOLAN BLISTER
3911 NDA/MAL/H AJANTA ABACUS ARTEFAN ARTEMETHER 60MG + AJANTA PHARMA LIMITED- INDIA ORAL SOLID 1.0X30.0X 11/26/2019
DP/8795 PHARMA PHARMA 60/360 + 360MG B-4/5/6 MIDC PAITHAN ORDINARY 1.0X6.0
LIMITED (AFRICA) LUMEFANTRI DISTRICT AURANGABAD TABLETS TABLET
LIMITED NE MAHARASHTRA STATE BLISTER
INDIA 431 128
3912 NDA/MAL/H PSYCHOTROPI ABACUS AMITRIP-25 AMITRIPTYLI 25MG PSYCHOTROPICS INDIA INDIA ORAL SOLID 1.0X10.0X 11/26/2019
DP/8796 CS INDIA PHARMA NE LTD-PLOT NO. 46 & 49, ORDINARY 10.0
LIMITED. (AFRICA) HYDROCHLOR SECTOR-6A,IIE, TABLETS TABLET
LIMITED IDE SIDCUL,HARIDWAR - BLISTER
249403( UTTARAKHARD)
3913 NDA/MAL/H TENTH OF GAMA COLONA MEBEVERINE 100MG + TENTH OF RAMADAN FOR EGYPT ORAL SOLID 1.0X3.0X1 11/26/2019
DP/8797 RAMADAN PHARMACEUTIC HYDROCHLOR 25MG PHARMACEUTICAL ORDINARY 0.0
FOR ALS (U) LIMITED IDE + INDUSTRIES & TABLETS TABLET
PHARMACEUT SULPIRIDE DIAGNOSTIC REAGENTS BLISTER
ICALS (RAMEDA)-SECOND
DIAGNOSTICS EGYPT
REAGENTS(RA
MEDA)
3914 NDA/MAL/H MYLAN KIMSY MEDS ACRIPTEGA DOLUTEGRAV 50MG + MYLAN LABORATORIES INDIA ORAL SOLID 1.0X1.0X3 5/30/2018
DP/8814 LABORATORIE LTD IR SODIUM + 300MG + LIMITEDD ,-PLOT NO.11, ORDINARY 0.0
S LIMITED LAMIVUDINE 300MG 12 & 13, INDORE SPECIAL FILM- TABLET
+ TENOFOVIR ECONOMIC ZONE, COATED BOTTLE,1.
DISOPROXIL PHARMA ZONE, PHASE-II, TABLETS 0X90.0
FUMARATE SECTOR-III, PITHAMPUR- TABLET
454775 BOTTLE,1.
DIST. DHAR, MADHYA 0X180.0
PRADESH, INDIA. TABLET
BOTTLE
3915 NDA/MAL/H ZIM GITTOES ZIMAGRA – SLIDENAFIL 50 MG ZIM LABORATORIES LTD-B- INDIA OTHER 1.0X1.0X1 5/30/2018
DP/8815 LABORATORIE PHARMACEUTIC ODS 50 CITRATE 21/22, M.I.D.C. AREA, SYSTEMIC 0.0
S LTD ALS LIMITED KALMESHWAR – 441501, SPECIAL SACHET
DIST. NAGPUR, SOLIDS CARTON
MAHARASHTRA,
3916 NDA/MAL/H ABACUS ABACUS ABPARA PARACETAM 1%W/V ABACUS PARENTERAL UGANDA PARENTERAL 1.0X1.0X1 5/30/2018
DP/8816 PARENTERAL PARENTERAL OL DRUGS LIMITED-BLOCK ORDINARY 00.0 ML
DRUGS DRUGS LIMITED 191, PLOT NO. 114, INFUSION BOTTLE
LIMITED GWAWANYA KINGA AND BAGS
KAPEKA MUKONO
DISTRICT, UGANDA.
3917 NDA/MAL/H MEDIPHARM MEDIPHARM MEDISOLO PREDNISOLO 15MG/5ML MEDIPHARM INDUSTRIES( UGANDA ORAL LIQUID 1.0X1.0X5 5/30/2018
DP/8817 INDUSTRIES INDUSTRIES NE-15 NE SODIUM EA) LTD-PLOT 65 KAKAJJO ORDINARY .0 ML
(E.A) LTD (E.A) LTD PHOSPHATE ROAD BWEYOGERERE LIQUIDS BOTTLE
P.O.BOX
6218,KAMPALA,UGANDA
3918 NDA/MAL/H AJANTA ABACUS LEVOTOP- LEVOFLOXACI 1.5%W/V CIRON DRUGS & INDIA OPHTHALMI 1.0X1.0X5 5/30/2018
DP/8818 PHARMA LTD PHARMA PF N PHARMACEUTICALS PVT C DROPS .0 ML
(AFRICA) HEMIHYDRAT LTD-N-118, N-119 MIDC VIAL
LIMITED E TARAPUR BOISAR DIST
THANE 401506
MAHARASHTRA INDIA
3919 NDA/MAL/H UNOSOURCE ABACUS LORFACT-D DESLORATADI 5MG/5ML AKUMS DRUGS & INDIA ORAL LIQUID 1.0X1.0X1 5/30/2018
DP/8819 PHARMA LTD PHARMA SYRUP NE PHARMACEUTICALS LTD- ORDINARY 00.0 ML
(AFRICA) PLANT II-PLOT NO.22, SYRUPS BOTTLE
LIMITED SECTOR 6-A, IIE, SIDCUL,
RANIPUR,DISTRICT:
HARIDWAR 249 403, INDIA
3920 NDA/MAL/H TROIKAA ABACUS T-DOL P TRAMADOL 37.5MG + TROIKAA INDIA ORAL SOLID 1.0X10.0X 5/30/2018
DP/8820 PHARMACEUT PHARMA RAPID HYDROCHLOR 325MG PHARMACEUTICALS LTD .- ORDINARY 10.0
ICALS LIMITED (AFRICA) IDE + C-1 SARA INDUSTRIAL TABLETS TABLET
LIMITED PARACETAM ESTATE SELAQUI BLISTER
OL DEHRADUN 248197
3921 NDA/MAL/H ABACUS ABACUS ALIDO LIDOCAINE 2%W/V LINCOLN PARENTERAL INDIA PARENTERAL 1.0X1.0X3 5/30/2018
DP/8822 PARENTERAL PHARMA HYDROCHLOR LIMITED- 11, TRIMUL ORDINARY 0.0 ML
DRUGS (AFRICA) IDE ESTATE, KHATRAJ, TAL. VIALS VIAL
LIMITED. LIMITED KALOL,
DIST. GANDHINAGAR,
GUJARAT, INDIA.
3922 NDA/MAL/H GILEAD MEDICAL EPCLUSA SOFOSBUVIR 400MG + PATHEON INC.--TORONTO CANADA ORAL SOLID 1.0X1.0X2 5/30/2018
DP/8823 SCIENCE INC ACCESS + VELPATASIR 100MG REGIONAL OPERATIONS ORDINARY 8.0
(UGANDA) 2100, SYNTEX COURT, FILM- TABLET
LIMITED MISSISSAUGA, ONTARIO, COATED BOTTLE
CANADA, L5N 7K9 TABLETS
3923 NDA/MAL/H AJANTA ABACUS NEPAFLAM NEPAFENAC 0.1% W/V CIRON DRUGS & INDIA OPHTHALMI 1.0X1.0X5 5/30/2018
DP/8824 PHARMA LTD PHARMA PHARMACEUTICALS PVT C .0 ML
(AFRICA) LTD-N-118, N-119 MIDC SUSPENSION VIAL
LIMITED TARAPUR BOISAR DIST S
THANE 401506
MAHARASHTRA INDIA
3924 NDA/MAL/H LINCOLN METRO LAXALINK LACTULOSE 3.35G/5ML LINCOLN PARENTERAL INDIA ORAL LIQUID 1.0X1.0X1 5/30/2018
DP/8825 PHARMACEUT PHARMACEUTIC LIMITED- 11, TRIMUL ORDINARY 50.0 ML
ICALS LTD ALS LIMITED ESTATE, KHATRAJ, TAL. LIQUIDS BOTTLE
KALOL,
DIST. GANDHINAGAR,
GUJARAT, INDIA.
3925 NDA/MAL/H CIPLA LTD. QUALITY ABACAVIR ABACAVIR 120MG + CIPLA LIMITED -PLOT NO A INDIA ORAL SOLID 1.0X1.0X6 5/30/2018
DP/8826 CHEMICALS LTD - SULFATE SULFATE + 60MG – 33, A – 2 (UNIT – I), ORDINARY 0.0
HUMAN AND LAMIVUDINE MIDC PATALGANGA, ORALLY TABLET
LAMIVUDIN DISTRICT RAIGAD, 410 220 DISINTEGRA BOTTLE
E TABLETS MAHARASHTRA, INDIA TING
FOR ORAL TABLETS
SUSPENSIO
N 120/60
MG
3926 NDA/MAL/H HETERO LABS AIVEEN (U) SOFGEN SOFOSBUVIR 400 MG HETERO LABS LIMITED INDIA ORAL SOLID 1.0X1.0X2 5/30/2018
DP/8827 LTD LIMITED UNIT-VI --APIIC ORDINARY 8.0
FORMULATION SEZ, FILM- TABLET
POLEPALLY VILLAGE, COATED BOTTLE
JADCHERLA MANDAL, TABLETS
MAHABOOB NAGAR DIST -
509301, TELANGANA,
INDIA
3927 NDA/MAL/H HELSINN SURGIPHARM ALOXI PALONOSTER 50MCG/5 PIERRE FABRE FRANCE PARENTERAL 1.0X5.0 11/27/2019
DP/8828 BIREX (U) LIMITED ON ML MEDICAMENT ORDINARY ML VIAL
PHARMACEUT HYDROCHLOR PRODUCTION - - VIALS
ICALS IDE AQUITAINE PHARM
INTERNATIONAL 1,
AVENUE DE BEARN 64320
IDRON FRANCE HELSIN
BIREX PHARMACEUTICAL
LTD --DAMASTOWN
MULHUDDART DUBLIN 15
IRELAND
3928 NDA/MAL/H HETERO LABS AIVEEN (U) DOLUTEGR DOLUTEGRAV 50MG + HETERO LABS PRIVATE INDIA ORAL SOLID 1.0X1.0X3 12/20/2018
DP/8829 LTD LIMITED AVIR IR SODIUM + 300MG + LIMITED UNIT III-SURVEY ORDINARY 0.0
SODIUM + LAMIVUDINE 300MG NO. 51, PLOT 22-110, FILM- TABLET
LAMIVUDIN + TENOFOVIR INDUSTRIAL COATED BOTTLE,1.
E+ DISOPROXIL DEVELOPMENT AREA TABLETS 0X90.0
TENOFOVIR FUMARATE (I.D.A) JEEDIMETLA, TABLET
DISOPROXIL HYDERABAD-500 055, BOTTLE,1.
FUMARATE TELANGANA STATE 0X180.0
TABLET
BOTTLE
3929 NDA/MAL/H HETERO LABS AIVEEN (U) IRBIS-HT IRBESARTAN 300MG + HETERO LABS LIMITED INDIA ORAL SOLID 1.0X3.0X1 11/26/2019
DP/8830 LTD LIMITED + 12.5MG (UNIT V)-SY NO. 436,440, ORDINARY 0.0
HYDROCHLOR 441 & 458, APIIC TABLETS TABLET
OTHIAZIDE FORMULATION SEZ, BLISTER
POLEPALLY (V),
JEDCHERLA (M),
MAHABOOBNAGAR,
DISTRICT ANDHRA
PRADESH 509301
3930 NDA/MAL/H HETERO LABS AIVEEN (U) PREGA 75 PREGABALIN 75MG HETERO LABS PRIVATE INDIA ORAL SOLID 1.0X3.0X1 11/26/2019
DP/8831 LTD LIMITED LIMITED UNIT III-SURVEY ORDINARY 0.0
NO. 51, PLOT 22-110, CAPSULES CAPSULE
INDUSTRIAL BLISTER
DEVELOPMENT AREA
(I.D.A) JEEDIMETLA,
HYDERABAD-500 055,
TELANGANA STATE
3931 NDA/MAL/H EXPHAR S.A. SURGIPHARM GASTRICID FAMOTIDINE 10 MG + MILAN LABORATORIES INDIA ORAL SOLID 1.0X4.0 11/7/2018
DP/8836 ZONING (U) LIMITED BP + 165 MG + (INDIA ) PVT LTD-PLOT ORDINARY TABLET
INDUSTRIEL MAGNESIUM 800 MG NO.63-67 & 87,JAWAHAR CHEWABLE STRIP
DE NIVELLES HYDROXIDE CO.OP.INDUSTRIAL TABLETS
SUD BP + ESTATE LTD
CALCIUM KAMOTHE,PANVEL DIST.
CARBONATE THANE,MAHARASTRA-
BP 410209,INDIA
3932 NDA/MAL/H HETERO LABS AIVEEN (U) PREGA 150 PREGABALIN 150MG HETERO LABS PRIVATE INDIA ORAL SOLID 1.0X3.0X1 11/26/2019
DP/8838 LTD LIMITED LIMITED UNIT III-SURVEY ORDINARY 0.0
NO. 51, PLOT 22-110, CAPSULES CAPSULE
INDUSTRIAL BLISTER
DEVELOPMENT AREA
(I.D.A) JEEDIMETLA,
HYDERABAD-500 055,
TELANGANA STATE
3933 NDA/MAL/H MACK SHURIK LTD HEALTH FERRIC 900MG + TORQUE INDIA ORAL LIQUID 1.0X100.0 11/26/2019
DP/8839 BROWN RICH AMMONIUM 10MG + PHARMACEUTICALS PVT ORDINARY ML
PHARMECEUT CITRATE + 20MG + LTD -VILL. ISSAPUR, P.O. SYRUPS BOTTLE
ICALS PVT LTD FOLIC ACID + 40MG + DAPPAR, PUNJAB-140506
VITAMIN B1 200MG +
HCL + 360MG
VITAMIN B6 /5ML
HCL +
NICOTINAMI
DE + VITAMIN
B12
3934 NDA/MAL/H SQUARE GAMA CEFOTIL CEFUROXIME 500MG SQUARE BANGLADESH ORAL SOLID 1.0X2.0X6 11/26/2019
DP/8843 PHARMACEUT PHARMACEUTIC 500 AXETIL PHARMACEUTICALS ORDINARY .0 TABLET
ICALS LTD. ALS (U) LIMITED LIMITED - DHAKA UNIT- TABLETS BLISTER
KALIAKOIR GAZIPUR
3935 NDA/MAL/H SOUTH EGYPT WIDE VENAXAN LEVOFLOXACI 500 MG SOUTH EGYPT DRUG INDIA ORAL SOLID 1.0X1.0X5 12/3/2018
DP/8844 DRUG SPECTRUM 500 MG N INDUSTRIES CO-1ST ORDINARY .0 TABLET
INDUSTRIES ENTERPRISES HEMIHYDRAT INDUSTRIAL ZONE, 6 FILM- BLISTER
CO. (SEDICO) (U) LIMITED E OCTOBER CITY, EGYPT. COATED
TABLETS
3936 NDA/MAL/H SWISS SHREEJI FUROSEMI FUROSEMIDE 10MG/ML SWISS PARENTERALS PVT INDIA PARENTERAL 1.0X10.0X 11/26/2019
DP/8845 PARENTERALS PHARMACEUTIC DE LTD ..-809, KERALA ORDINARY 2.0 ML
LTD ALS LIMITED INDUSTRIAL ESTAE, GIDC AMPOULES AMPOULE
NEAR BAVLA,
AHMEDABAD 382220,
GUJARAT
3937 NDA/MAL/H UNITED WIDE ATOXIA 120 ETORICOXIB 120 MG UNITED JORDAN ORAL SOLID 1.0X1.0X7 7/25/2018
DP/8915 PHARMACEUT SPECTRUM MG PHARMACEUTICAL ORDINARY .0 TABLET
ICAL ENTERPRISES MANUFACTURING CO. LTD- FILM- BLISTER
MANUFACTU (U) LIMITED -P.O. BOX 69 AMMAN COATED
RING CO. LTD 11591 - AL-RAGEEM TABLETS
SAHAB - JORDAN
3938 NDA/MAL/H MACLEODS NORVIK TAMSUMA TAMSULOSIN 0.4MG MACLEODS INDIA ORAL SOLID 1.0X1.0X1 7/25/2018
DP/8916 PHARMACEUT ENTERPRISES C 0.4 HYDROCHLOR PHARMACEUTICALS RETARD 0.0
ICALS LTD LIMITED IDE LIMITED -BLOCK-N2 CAPSULES CAPSULE
VILLAGE THEDA POST BLISTER
OFFICE LODHIMAJRA
SOLAN HIMACHAL
PRADESH – 174101
INDIA
3939 NDA/MAL/H SVIZERA LABS GITTOES SCC-2 LLW RIFAMPICIN + 150MG + SVIZERA LABS PRIVATE INDIA ORAL SOLID 1.0X24.0X 7/25/2018
DP/8917 PRIVATE LTD PHARMACEUTIC TABLETS ISONIAZID 75MG LIMITED-PLOT D-16/6 TTC ORDINARY 28.0
ALS LIMITED INDUSTRIAL AREA MIDC FILM- TABLET
TURBHE NAVI MUMBAI COATED BLISTER
400703, INDIA TABLETS
3940 NDA/MAL/H SVIZERA LABS GITTOES SCC-3 LLW RIFAMPICIN + 150MG + SVIZERA LABS PRIVATE INDIA ORAL SOLID 1.0X24.0X 7/25/2018
DP/8918 PRIVATE LTD PHARMACEUTIC TABLETS ISONIAZID + 75MG + LIMITED-PLOT D-16/6 TTC ORDINARY 28.0
ALS LIMITED ETHAMBUTO 275MG INDUSTRIAL AREA MIDC FILM- TABLET
L TURBHE NAVI MUMBAI COATED BLISTER
HYDROCHLOR 400703, INDIA TABLETS
IDE
3941 NDA/MAL/H SVIZERA LABS GITTOES SCC-4 RIFAMPICIN + 150MG + SVIZERA LABS PRIVATE INDIA ORAL SOLID 1.0X24.0X 7/25/2018
DP/8919 PRIVATE LTD PHARMACEUTIC TABLETS ISONIAZID + 75MG + LIMITED-PLOT D-16/6 TTC ORDINARY 28.0
ALS LIMITED PYRAZINAMI 400MG + INDUSTRIAL AREA MIDC FILM- TABLET
DE + 275MG TURBHE NAVI MUMBAI COATED BLISTER
ETHAMBUTO 400703, INDIA TABLETS
L
HYDROCHLOR
IDE
3942 NDA/MAL/H MERCK UNITED CRINONE PROGESTERO 90MG/APP FLEET LABORATORIES LTD - UNITED VAGINAL 1.0X1.0X1 7/25/2018
DP/8920 HEALTHCARE 8% GEL NE LICATOR -94 RICKMANSWORTH KINGDOM GELS AND 5.0
DISTRIBUTORS ROAD, WATFORD, HERT, SOLS POUCH
LTD WD18 7JJ, UNITED CARTON
KINGDOM
3943 NDA/MAL/H BIOLOGICAL GITTOES DIPHTHERI DIPHTHERIA 2 LF ( NOT BIOLOGICAL E. LIMITED-- INDIA PARENTERAL 1.0X24.0X 7/25/2018
DP/8927 E. LTD PHARMACEUTIC A AND TOXOID + LESS THAN PLOT NO.1 SHAPOORJI ORDINARY 1.0X10.0
ALS LIMITED TETANUS TETANUS 2 IU) + 8.8 PALLONJI BIOTECH PARK VIALS DOSE
VACCINE TOXOID LF (NOT PHASE II, KOLTHUR VIAL,1.0X
(ADSORBED LESS THAN VILLAGE, SHAMEERPET, 48.0X1.0
REDUCED 20 IU)/ MANDAL, R.R. DISTRICT, DOSE VIAL
ANTIGEN(S) 0.5ML ANDRA PRADESH 500078,
CONTENT) INDIA
3944 NDA/MAL/H OCTAPHARM PHILLIPS ALBUNORM HUMAN 20%W/V OCTAPHARMA GERMANY PARENTERAL 1.0X1.0X5 7/1/2018
DP/8929 A AG PHARMACEUTIC ALBUMIN PRODUKTIONSGESELLSCH ORDINARY 0.0 ML
ALS (UGANDA) AFT DEUTSCHLAND MBH-- INFUSION BOTTLE,1.
LIMITED WOLFGANG-MARGUERRE- VIALS/BOTTL 0X1.0X100
ALLEE 1 31832 SPRINGE ES .0 ML
GERMANY BOTTLE
3945 NDA/MAL/H CARITAS REDDYS SODIUM SODIUM 0.9%W/V SICHUAN KELUN CHINA PARENTERAL 1.0X500.0 7/25/2018
DP/8931 HEALTHCARE PHARMA CHLORIDE CHLORIDE PHARMACEUTICAL CO., ORDINARY ML
PVT. LTD LIMITED INTRAVEN LTD-SOUTH OF NO.2 INFUSION BOTTLE
OUS ROAD, XINDU SATELLITE VIALS/BOTTL
INFUSION CITY INDUSTRIAL ES
BP DEVELOPMENT ZONE,
CHENGDU, SICHUAN
PROVINCE 610500, P. R.
CHINA
3946 NDA/MAL/H CIPLA LTD QUALITY Q-TIB SULFAMETHO 800MG + CIPLA LIMITED>-A-33, A- INDIA ORAL SOLID 1.0X1.0X3 7/25/2018
DP/8933 CHEMICALS LTD - XAZOLE + 160MG + 37/2/2 & A-2, M.I.D.C, ORDINARY 0.0
HUMAN TRIMETHOPRI 300MG PATALANGA 410 220, TABLETS TABLET
M+ +25MG DISTRICT RAIGAD, M.S, BOTTLE
ISONIAZID + INDIA
PYRIDOXINE
HYDROCHLOR
IDE
3947 NDA/MAL/H ABACUS ABACUS CYCLO P CYCLOPENTO 1.0%W/V ABACUS PARENTERAL UGANDA OPHTHALMI 1.0X1.0X1 7/25/2018
DP/8934 PARENTERAL PARENTERAL EYE DROPS LATE DRUGS LIMITED-BLOCK C DROPS 0.0 ML
DRUGS DRUGS LIMITED HYDROCHLOR 191, PLOT NO. 114, VIAL
LIMITED IDE GWAWANYA KINGA AND
KAPEKA MUKONO
DISTRICT, UGANDA.
3948 NDA/MAL/H AL-FAZAL HEALTHCARE FECLO GEL DICLOFENAC 1%W/W AL-FAZAL PHARMA PAKISTAN TOPICAL 1.0X1.0X2 7/25/2018
DP/8935 PHARMA LTD. DIETHYLAMM INDUSTRIES (PVT.) LTD- EXTERNAL 0.0 G
INDUSTRIES ONIUM SALT PLOT 20,21,22- DEFENCE EMULSION TUBE,1.0X
(PVT.) LTD INDUSTRIAL ZONE- GELS 1.0X15.0
MOMAN PURA, 16KM G TUBE
SHEIKHUPURA ROAD,
(LAHORE) - PAKISTAN
3949 NDA/MAL/H AL-FAZAL HEALTHCARE ESOFOLE ESOMEPRAZO 40MG AL-FAZAL PHARMA PAKISTAN ORAL SOLID 1.0X2.0X7 7/25/2018
DP/8936 PHARMA LTD. LE INDUSTRIES (PVT.) LTD- ORDINARY .0
INDUSTRIES MAGNESIUM PLOT 20,21,22- DEFENCE CAPSULES CAPSULE
(PVT.) LTD TRIHYDRATE INDUSTRIAL ZONE- BLISTER
MOMAN PURA, 16KM
SHEIKHUPURA ROAD,
(LAHORE) - PAKISTAN
3950 NDA/MAL/H FREDUN PLANET RHINOCOL PARACETAM 500MG + FREDUN INDIA ORAL SOLID 1.0X50.0X 7/25/2018
DP/8939 PHARMACEUT PHARMACEUTIC D OL + 10MG + PHARMACEUTICALS LTD -- ORDINARY 1.0X4.0
ICALS LTD ALS UGANDA PHENYLEPHRI 2MG + 14, 15, 16, ZORABIAN TABLETS TABLET
LTD NE 30MMG INDUSTRIAL COMPLEX, BLISTER
HYDROCHLOR VILLAGE, VEOOR,
IDE + PALGHAR (EAST)
CHLORPHENI DIST: THANE – 401 404 -
RAMINE INDIA
MALEATE +
CAFFEINE
(ANHYDROUS
)
3951 NDA/MAL/H İLKO İLAÇ CORE ACCESS RABIZA RABEPRAZOL 20MG İLKO İLAÇ SANAYI VE TURKEY ORAL SOLID 1.0X2.0X1 7/25/2018
DP/8940 SANAYI VE LIMITED 20MG E SODIUM TICARET A. Ş.-3. 42050 ORDINARY 4.0
TICARET A. Ş. SELÇUKLU / KONYA ENTERIC- TABLET
TABLETS
3952 NDA/MAL/H İLKO İLAÇ CORE ACCESS LIVERCOL ROSUVASTATI 20MG İLKO İLAÇ SANAYI VE TURKEY ORAL SOLID 1.0X2.0X1 7/25/2018
DP/8941 SANAYI VE LIMITED 20MG N CALCIUM TICARET A. Ş.-3. 42050 ORDINARY 4.0
TICARET A. Ş. SELÇUKLU / KONYA FILM- TABLET
TABLETS
3953 NDA/MAL/H HETERO LABS AIVEEN (U) IRBIS-HT IRBESARTAN 150MG + HETERO LABS LIMITED INDIA ORAL SOLID 1.0X3.0X1 11/26/2019
DP/8943 LTD LIMITED 150/12.5 + 12.5MG (UNIT V)-SY NO. 436,440, ORDINARY 0.0
HYDROCHLOR 441 & 458, APIIC TABLETS TABLET
OTHIAZIDE FORMULATION SEZ, BLISTER
POLEPALLY (V),
JEDCHERLA (M),
MAHABOOBNAGAR,
DISTRICT ANDHRA
PRADESH 509301
3954 NDA/MAL/H GUILIN STAR GAMOK AMOXICILLIN 500MG + SINOPHARM WEIQIDA CHINA ORAL SOLID 1.0X1.0X1 7/25/2018
DP/8944 PHARMACEUT PHARMACEUTIC 625MG TRIHYDRATE 125MG PHARMACEUTICAL CO., ORDINARY 0.0
ICALS CO.LTD. ALS LTD + LTD-OSD WORKSHOP OF FILM- TABLET
CLAVULANAT ECONOMIC & COATED BLISTER
E POTASSIUM TECHNOLOGICAL TABLETS
DEVELOPMENT ZONE,
SECOND MEDICAL ZONE
DATONG, SHANXI, CHINA
3955 NDA/MAL/H GUILIN STAR GAMOK AMOXICILLIN 500MG + SINOPHARM WEIQIDA CHINA PARENTERAL 1.0X10.0X 7/25/2018
DP/8946 PHARMACEUT PHARMACEUTIC 0.6G SODIUM + 100MG PHARMACEUTICAL CO., ORDINARY 0.6 G VIAL
ICALS CO.LTD. ALS LTD CLAVULANAT LTD-OSD WORKSHOP OF DRY VIALS
E POTASSIUM ECONOMIC &
TECHNOLOGICAL
DEVELOPMENT ZONE,
SECOND MEDICAL ZONE
3956 NDA/MAL/H GUILIN STAR GAMOK AMOXICILLIN 1G + 0.2G SINOPHARM WEIQIDA CHINA PARENTERAL 1.0X10.0X 7/25/2018
DP/8947 PHARMACEUT PHARMACEUTIC 1.2G SODIUM + PHARMACEUTICAL CO., ORDINARY 1.2 G VIAL
ICALS CO.LTD. ALS LTD CLAVULANAT LTD-OSD WORKSHOP OF DRY VIALS
E POTASSIUM ECONOMIC &
TECHNOLOGICAL
DEVELOPMENT ZONE,
SECOND MEDICAL ZONE
3957 NDA/MAL/H EGYPTIAN WIDE CETAL PARACETAM 120MG EGYPTIAN EGYPT RECTAL 1.0X1.0X5 7/1/2018
DP/8949 INTERNATION SPECTRUM SUPOSITOR OL INTERNATIONAL SYSTEMIC .0
AL ENTERPRISES IES PHARMACEUTICAL SUPPOSITORI SUPPOSIT
PHARMACEUT (U) LIMITED INDUSTRIES CO. A.R.E- ES ORY
ICAL 10TH OF RAMADAN CITY BLISTER
COMPANY B1,EGYPT
3958 NDA/MAL/H JOHNSON PHILLIPS BENYLIN GUAIFENESIN 100MG JOHNSON&JOHNSON PTY SOUTH ORAL LIQUID 1.0X1.0X1 7/25/2018
DP/8953 &JOHNSON PHARMACEUTIC CHILDREN'S PER 10ML LTD.-EDMS BPK241 MAIN AFRICA ORDINARY 00.0 ML
(PTY) LTD ALS (UGANDA) WET ROAD /HOOFWEG LIQUIDS BOTTLE
LIMITED COUGH 241,RETREAT 7945,SOUTH
AFRICA
3959 NDA/MAL/H JOHNSON PHILLIPS BENYLIN GUAIFENESIN 200MG JOHNSON&JOHNSON PTY SOUTH ORAL LIQUID 1.0X1.0X5 7/25/2018
DP/8954 &JOHNSON PHARMACEUTIC WET PER 10ML LTD.-EDMS BPK241 MAIN AFRICA ORDINARY 0.0 ML
(PTY) LTD ALS (UGANDA) COUGH ROAD /HOOFWEG LIQUIDS BOTTLE,1.
LIMITED 241,RETREAT 7945,SOUTH 0X1.0X100
AFRICA .0 ML
BOTTLE,1.
0X1.0X200
.0 ML
BOTTLE
3960 NDA/MAL/H MYLAN KIMSY MEDS SULFAMET SULFAMETHO 400MG + MYLAN LABORATORIES INDIA ORAL SOLID 1.0X1.0X1 9/26/2018
DP/9051 LABORATORIE LTD HOXAZOLE/ XAZOLE + 80MG LTD-PLOT NO.11, 12 & 13, ORDINARY 0.0
S LIMITED TRIMETHO TRIMETHOPRI INDORE SPECIAL TABLETS TABLET
PRIM M ECONOMIC ZONE, BLISTER
TABLETS PHARMA ZONE, PHASE II,
USP SECTOR III, PITHAMPUR -
454775; DIST; DHAR;
MADHYA PRADESH;
3961 NDA/MAL/H MYLAN KIMSY MEDS SULFAMET SULFAMETHO 800MG + MYLAN LABORATORIES INDIA ORAL SOLID 1.0X1.0X1 9/26/2018
DP/9052 LABORATORIE LTD HOXAZOLE/ XAZOLE + 160MG LTD-PLOT NO.11, 12 & 13, ORDINARY 0.0
S LIMITED TRIMETHO TRIMETHOPRI INDORE SPECIAL TABLETS TABLET
PRIM M ECONOMIC ZONE, BLISTER
TABLETS PHARMA ZONE, PHASE II,
USP SECTOR III, PITHAMPUR -
454775; DIST; DHAR;
MADHYA PRADESH;
3962 NDA/MAL/H GUILIN PHILLIPS D-ARTEPP® DIHYDROART 60MG + GUILIN PHARMACEUTICAL CHINA ORAL SOLID 1.0X1.0X6 9/26/2018
DP/9057 PHARMACEUT PHARMACEUTIC EMISININ + 480MG CO LTD--NO. 43 QILIDIAN ORDINARY .0 TABLET
ICAL CO.LTD ALS (UGANDA) PIPERAQUINE ROAD GUILIN 541004 FILM- BLISTER
LIMITED PHOSPHATE GUANGXI COATED
TABLETS
3963 NDA/MAL/H GUILIN PHILLIPS D-ARTEPP® DIHYDROART 30MG + GUILIN PHARMACEUTICAL CHINA ORAL SOLID 1.0X2.0X3 9/26/2018
DP/9058 PHARMACEUT PHARMACEUTIC DISPERSIBL EMISININ + 240MG CO LTD--NO. 43 QILIDIAN ORDINARY .0 TABLET
ICAL CO.LTD ALS (UGANDA) E PIPERAQUINE ROAD GUILIN 541004 SOLUBLE BLISTER
LIMITED PHOSPHATE GUANGXI TABLETS
3964 NDA/MAL/H CRATUS ABACUS CLASSMOX AMOXICILLIN 125MG/ML TWENTY FIRST CENTURY INDIA ORAL LIQUID 1.0X10.0 9/26/2018
DP/9059 PHARMA PVT. PHARMA DROPS TRIHYDRATE PHARMACEUTICALS ORDINARY ML
LTD (AFRICA) PVT.LTD - -UNIT II, DRY BOTTLE
LIMITED KHASRA NO: 282, NALHERI SUSPENSION
DEHVIRAN, S/SYRUPS/D
NALHERA ROPS
ANANTPUR,PUHANA -
IQBALPUR ROAD,
HARIDWAR,
UTTARAKHAND
3965 NDA/MAL/H AJANTA ABACUS ADERAN 32 CANDESARTA 32 MG AJANTA PHARMA LIMITED- INDIA ORAL SOLID 1.0X3.0X1 9/26/2018
DP/9062 PHARMA LTD PHARMA N CILEXETIL B-4-5-6, MIDC AREA ORDINARY 0.0
(AFRICA) PAITHAN, AURANGABAD, TABLETS TABLET
LIMITED 431148 BLISTER
DIST:AURANGABAD
MAHARASHTRA, INDIA.
3966 NDA/MAL/H LAURUS LABS BEYOND TENOFOVIR TENOFOVIR 300 MG LAURUS LABS LIMITED, INDIA ORAL SOLID 1.0X1.0X3 9/26/2018
DP/9063 LIMITED - LOGISTICS LTD DISOPROXIL DISOPROXIL (UNIT-2) - -PLOT NO:19, 20 ORDINARY 0.0
FUMARATE FUMARATE & 21,WESTERN SECTOR, FILM- TABLET
TABLETS APSEZ, COATED BOTTLE
300 MG ATCHUTAPURAM TABLETS
MANDAL,
VISAKHAPATNAM-
DISTRICT-531011,
3967 NDA/MAL/H THEON AIVEEN (U) THEOMOX- AMOXICILLIN 250 MG THEON INDIA ORAL SOLID 1.0X10.0X 9/26/2018
DP/9064 PHARMACEUT LIMITED 250 TRIHYDRATE PHARMACEUTICALS ORDINARY 10.0
ICALS LTD LIMITED.- CAPSULES CAPSULE
VILLAGE SAINI MAJRA, BLISTER
SOLAN, HIMACHAL
3968 NDA/MAL/H THEON AIVEEN (U) THEOFLEX - CEFALEXIN 250 MG THEON INDIA ORAL SOLID 1.0X10.0X 9/26/2018
DP/9065 PHARMACEUT LIMITED 250 MONOHYDRA PHARMACEUTICALS ORDINARY 10.0
ICALS LTD TE LIMITED.- CAPSULES CAPSULE
VILLAGE SAINI MAJRA, BLISTER
SOLAN, HIMACHAL
3969 NDA/MAL/H THEON AIVEEN (U) THEOFIX- CEFIXIME 200 MG THEON INDIA ORAL SOLID 1.0X2.0X1 9/26/2018
DP/9066 PHARMACEUT LIMITED 200 TRIHYDRATE PHARMACEUTICALS ORDINARY 0.0
ICALS LTD LIMITED.- FILM- TABLET
VILLAGE SAINI MAJRA, COATED BLISTER
TEHSIL NALAGARH, DISTT. TABLETS
SOLAN, HIMACHAL
3970 NDA/MAL/H MS PHARMA WIDE LOXAMOX LEVOFLOXACI 250MG/50 MS PHARMA - JORDAN- JORDAN PARENTERAL 1.0X50.0 11/28/2019
DP/9129 JORDAN SPECTRUM N ML PLOT NO. 356, STREET NO. ORDINARY ML BAG
CO.LTD ENTERPRISES HEMIHYDRAT 6, KING ABDULLAH II BIN INFUSION
(U) LIMITED ES AL- HUSSEIN INDUSTRIAL BAGS
ESTATE, SOUTH- WESTERN
EDGE SAHAB ZONE.
3971 NDA/MAL/H AUROLAB SWASTIK MFLOX-DM MOXIFLOXACI 0.5%W/V + AUROLAB LIMITED-NO 1 INDIA OPHTHALMI 1.0X5.0 11/26/2019
DP/9130 PHARMACEUTIC N+ 0.1%W/V SIVAGANGAI MAIN ROAD, C DROPS ML
AL LTD DEXAMETHAS VEERAPANJAN MADURAI BOTTLE
ONE SODIUM – 625 020 TAMIL NADU
PHOSPHATE INDIA
3972 NDA/MAL/H INCEPTA ECHO TRIDOSIL AZITHROMYCI 250MG INCEPTA BANGLADESH ORAL SOLID 1.0X2.0X3 11/26/2019
DP/9131 PHARMACUTI PHARMACY (U) N DIHYDRATE PHARMACEUTICALS LTD .- ORDINARY .0 TABLET
CALS LIMITED LIMITED DEWAN IDRIS ROAD, BARA TABLETS BLISTER
RANGAMATIA, ZIRABO,
SAVAR-DHAKA
3973 NDA/MAL/H INCEPTA ECHO PANTONIX PANTOPRAZO 40MG INCEPTA BANGLADESH ORAL SOLID 1.0X5.0X1 11/26/2019
DP/9132 PHARMACUTI PHARMACY (U) 40 LE PHARMACEUTICALS LTD .- ORDINARY 0.0
SAVAR-DHAKA
3974 NDA/MAL/H INCEPTA ECHO SEASONIX LEVOCETIRIZI 2.5MG/5M INCEPTA BANGLADESH ORAL LIQUID 1.0X60.0 11/26/2019
DP/9133 PHARMACUTI PHARMACY (U) NE L PHARMACEUTICALS LTD .- ORDINARY ML
CALS LIMITED LIMITED DEWAN IDRIS ROAD, BARA SYRUPS BOTTLE
RANGAMATIA, ZIRABO,
SAVAR-DHAKA
3975 NDA/MAL/H INCEPTA ECHO ONASERON ONDANSETR 8MG INCEPTA BANGLADESH ORAL SOLID 1.0X3.0X1 11/26/2019
DP/9134 PHARMACUTI PHARMACY (U) ON PHARMACEUTICALS LTD .- ORDINARY 0.0
SAVAR-DHAKA
3976 NDA/MAL/H ILKO ILAC CORE ACCESS QUELEPT QUETIAPINE 100MG ILKO ILAC SANAYI VE TURKEY ORAL SOLID 1.0X3.0X1 11/26/2019
DP/9135 SAN,VE.TICAR LIMITED TICARET A.S-3.ORGANIZE ORDINARY 0.0
ET.A.S, SANAYI BOLGESI, BUYUK TABLETS TABLET
KAYACIK MAH. KUDDISI BLISTER
CAD.23 SOKAKNO. 1 42050
SELCUKLU, KONYA
3977 NDA/MAL/H I CARE AIVEEN (U) I-CEF DPS CEFIXIME 50MG/5ML CORONA REMEDIES PVT. INDIA ORAL LIQUID 1.0X100.0 11/26/2019
DP/9136 PHARMA LIMITED LTD-VILLAGE JATOLI, POST ORDINARY ML
LIMITED OFFICE- OACHGHAT, DRY BOTTLE
TEHSIL, SOLAN, DISTT. SUSPENSION
SOLAN (H.P) 173223 S/SYRUPS/D
ROPS
3978 NDA/MAL/H I CARE AIVEEN (U) DOM R RABEPRAZOL 20MG + CORONA REMEDIES PVT. INDIA ORAL SOLID 1.0X3.0X1 11/26/2019
DP/9137 PHARMA LIMITED E SODIUM + 30MG LTD-VILLAGE JATOLI, POST ORDINARY 0.0
LIMITED DOMPERIDO OFFICE- OACHGHAT, CAPSULES CAPSULE
NE SR TEHSIL, SOLAN, DISTT. BLISTER
SOLAN (H.P) 173223
3979 NDA/MAL/H I CARE AIVEEN (U) L-THROX 50 LEVOTHYROXI 50MCG CORONA REMEDIES PVT. INDIA ORAL SOLID 1.0X100.0 11/26/2019
DP/9138 PHARMA LIMITED NE SODIUM LTD-VILLAGE JATOLI, POST ORDINARY TABLET
LIMITED OFFICE- OACHGHAT, TABLETS BOTTLE
SOLAN (H.P) 173223
3980 NDA/MAL/H I CARE AIVEEN (U) L THROX LEVOTHYROXI 100MCG CORONA REMEDIES PVT. INDIA ORAL SOLID 1.0X100.0 11/26/2019
DP/9139 PHARMA LIMITED 100 NE SODIUM LTD-VILLAGE JATOLI, POST ORDINARY TABLET
LIMITED OFFICE- OACHGHAT, TABLETS BOTTLE
SOLAN (H.P) 173223
3981 NDA/MAL/H I CARE AIVEEN (U) CLOMIPHE CLOMIPHENE 50MG CORONA REMEDIES PVT. INDIA ORAL SOLID 1.0X1.0X1 11/26/2019
DP/9140 PHARMA LIMITED NE CITRATE CITRATE LTD-VILLAGE JATOLI, POST ORDINARY 0.0
LIMITED OFFICE- OACHGHAT, TABLETS TABLET
TEHSIL, SOLAN, DISTT. BLISTER
SOLAN (H.P) 173223
3982 NDA/MAL/H I CARE AIVEEN (U) RABZOLE RABEPRAZOL 20MG + CORONA REMEDIES PVT. INDIA ORAL SOLID 1.0X3.0X1 11/26/2019
DP/9141 PHARMA LIMITED E SODIUM + 75MG LTD-VILLAGE JATOLI, POST ORDINARY 0.0
LIMITED LEVOSULPIRI OFFICE- OACHGHAT, CAPSULES CAPSULE
DE TEHSIL, SOLAN, DISTT. BLISTER
SOLAN (H.P) 173223
3983 NDA/MAL/H THEON AIVEEN (U) THEOFIX - CEFIXIME 50MG/5ML THEON INDIA ORAL LIQUID 1.0X60.0 11/26/2019
DP/9142 PHARMACEUT LIMITED 50 DS TRIHYDRATE PHARMACEUTICALS LTD ,- ORDINARY ML
ICALS VILLAGE SAINI MAJRA, DRY BOTTLE
LIMITTED TEHSIL, NALAGARH, DIST. SUSPENSION
SOLAN HP S/SYRUPS/D
ROPS
3984 NDA/MAL/H MSN PLANET PALOHALT PALONOSETR 0.25MG/5 MSN LABORATORIES (PVT) INDIA PARENTERAL 1.0X5.0 11/26/2019
DP/9143 LABORATORIE PHARMACEUTIC ON ML LTD-FORMULATIONS ORDINARY ML VIAL
S PRIVATE ALS UGANDA HYDROCHLOR DIVISION-PLOT NO. 42, VIALS
LIMITED, LTD IDE ANRICH INDUSTRIAL
ESTATE, BOLLARAM,
SANAGAREDDY DISTRICT-
502-325-TELENGANA,
3985 NDA/MAL/H BOEHERINGE SURGIPHARM METALYSE® TENECTAPLAS 50MG/10 BOEHRINGER INGELHEIM GERMANY PARENTERAL 1.0X20.0 11/27/2019
DP/9145 R INGELHEIM (U) LIMITED E ML PHARMA GMBH & CO. ORDINARY ML VIAL
INTERNATION KG.,-BIRKENDORFER VIALS
AL GMBH STRASSE 65, 88397,
3986 NDA/MAL/H MICRO LABS PHARMA VILLE ISONIAZID ISONIAZID 300MG MICRO LABS LIMITED .,-92, INDIA ORAL SOLID 1.0X10.0X 11/27/2019
DP/9146 LTD LIMITED SIPCOT, HOSUR 635126 ORDINARY 10.0
TABLETS TABLET
BLISTER,1.
0X24.0X28
.0 TABLET
BLISTER,1.
0X1000.0
TABLET
BOTTLE
3987 NDA/MAL/H SERUM NORVIK HUMAN LIVE ≥105.6 FFU SERUM INSTITUTE OF INDIA PARENTERAL 1.0X1.0X2 11/27/2019
DP/9147 INSTITUTE OF ENTERPRISES ROTAVIRUS ATTENUATED / INDIA PVT LTD .-212/2, ORDINARY .5 ML
INDIA LTD. LIMITED REASSORTA BOVINE - SEROTYPE HADAPSAR, PUNE- VIALS VIAL
NT HUMAN 411028, INDIA (1DOSE),1
ROTAVIRUS .0X1.0X5.
REASSORTAN 0 ML VIAL
T [G1, G2, G3, (2 DOSES)
G4 AND G9]
3988 NDA/MAL/H BOEHRINGER SURGIPHARM TWYNSTA TELMISARTA 80MG + ROTTENDORF PHARMA GERMANY ORAL SOLID 1.0X4.0X7 11/27/2019
DP/9148 INGELHEIM (U) LIMITED N+ 5MG GMBH-OSTENFELDER ORDINARY .0 TABLET
INTERNATION AMLODIPINE STRABE 51-61, 59320 TABLETS BLISTER
AL GMBH ENNIGERLOH CIPLA
LIMITED.-PLOT NO. L-139,
S-103 & M-62, VERNA
INDUSTRIAL ESTATE,
VERNA SALCETTE, GOA,
PIN 403722 BOEHRINGER
INGELHEIM PHARMA
GMBH & CO. KG-BINGER
STR. 173, 55216
3989 NDA/MAL/H BOEHRINGER SURGIPHARM TWYNSTA TELMISARTA 80MG + ROTTENDORF PHARMA GERMANY ORAL SOLID 1.0X4.0X7 11/27/2019
DP/9149 INGELHEIM (U) LIMITED N+ 10MG GMBH-OSTENFELDER ORDINARY .0 TABLET
INTERNATION AMLODIPINE STRABE 51-61, 59320 TABLETS BLISTER
AL GMBH ENNIGERLOH CIPLA
LIMITED.-PLOT NO. L-139,
S-103 & M-62, VERNA
INDUSTRIAL ESTATE,
VERNA SALCETTE, GOA,
PIN 403722 BOEHRINGER
INGELHEIM PHARMA
GMBH & CO. KG-BINGER
STR. 173, 55216
3990 NDA/MAL/H SERUM NORVIK PNEUMOC SEROTYPES 2MCG AND SERUM INSTITUTE OF INDIA PARENTERAL 1.0X50.0X 11/27/2019
DP/9150 INSTITUTE OF ENTERPRISES OCCAL 1+ 5+ 4MCG / INDIA PVT LTD .-212/2, ORDINARY 0.5 ML
INDIA PVT LIMITED POLYSACCH 9V+14+19A+1 0.5ML HADAPSAR, PUNE- VIALS VIAL,1.0X
LTD ARIDE 9F+23F+7F+6 411028, INDIA 50.0X2.5
CONJUGAT A AND ML VIAL
E VACCINE SEROTYPE 6B
3991 NDA/MAL/H UMEDICA VITACARE UMESTATIN- ATORVASTATI 10 MG UMEDICA LABORATORIES INDIA ORAL SOLID 1.0X3.0X1 11/27/2019
DP/9163 LABORATORIE LIMITED 10 N CALCIUM PVT. LTD-PLOT 221-GIDC, ORDINARY 0.0
S PVT LTD 2ND PHASE, VAPI 396195 TABLETS TABLET
GUJARAT BLISTER
3992 NDA/MAL/H HETERO LABS AIVEEN (U) VIRDAC 30 DACLATASVIR 30 MG HETERO LABS LIMITED INDIA ORAL SOLID 1.0X28.0 11/27/2019
DP/9166 LTD LIMITED DIHYDROCHL (UNIT V)-SY NO. 436,440, ORDINARY TABLET
ORIDE 441 & 458, APIIC TABLETS BOTTLE
FORMULATION SEZ,
POLEPALLY (V),
JEDCHERLA (M),
MAHABOOBNAGAR,
DISTRICT ANDHRA
PRADESH 509301
3993 NDA/MAL/H AICA ECHO ZOLEDRONI ZOLEDRONIC 4 MG BEU PHARMACY CUBA PARENTERAL 1.0X25.0 11/27/2019
DP/9167 LABORATORIE PHARMACY (U) C ACID ACID LABORATORIES LIORAD- ORDINARY VIAL
S COMPANY LIMITED MONOHYDRA 27A STREET NUMBER DRY VIALS CARTON
TE 26402 BETWEEN 264 AND
268, SAN AGUSTIN, LA
LISA
3994 NDA/MAL/H AMRING ERIS LTD ZOLEDRONI ZOLEDRONIC 0.8 MG/ML CLARIS INJECTABLES CUBA PARENTERAL 1.0X5.0 11/27/2019
DP/9168 FARMA S.R.L C ACID MONOHYDRA LIMITED-VASANA- ORDINARY ML VIAL
TE CHACHARWADI, TAL- VIALS
SANAND-382 213, INDIA
3995 NDA/MAL/H CADILA KARURI PROCTICAD LACTITOL 10 CADILA INDIA ORAL LIQUID 1.0X60.0 11/27/2019
DP/9169 PHARMACEUT PHARMACEUTIC MONOHYDRA GM/15ML PHARMACEUTICALS ORDINARY ML
ICALS LIMITED ALS LTD. TE LIMITED-1389, TRASAD LIQUIDS BOTTLE,1.
ROAD, DHOLKA- 382225, 0X100.0
DIST: AHMEDAD, GUJARAT ML
STATE, INDIA BOTTLE,1.
0X200.0
ML
BOTTLE
3996 NDA/MAL/H PROFARMA JOINT MEDICAL DOXYDERM DOXYCYCLINE 100MG PROFARMA SH.A-MYSLYM ALBANIA ORAL SOLID 1.0X1.0X1 1/10/2020
DP/9172 .SH.A STORE (UPMB - A MONOHYDRA KETA,TIRANA ORDINARY 0.0
UCMB) TE TABLETS TABLET
BLISTER
3997 NDA/MAL/H PROFARMA JOINT MEDICAL PRODEXA-T DEXAMETHAS 0.5MG PROFARMA SH.A-MYSLYM ALBANIA ORAL SOLID 1.0X2.0X1 1/10/2020
DP/9173 .SH.A STORE (UPMB - ONE KETA,TIRANA ORDINARY 0.0
UCMB) TABLETS TABLET
BLISTER,1.
0X3.0X10.
0 TABLET
BLISTER
3998 NDA/MAL/H PROFARMA JOINT MEDICAL ULCOZOL OMEPRAZOLE 20MG PROFARMA SH.A-MYSLYM ALBANIA ORAL SOLID 1.0X3.0X1 1/13/2020
DP/9174 .SH.A STORE (UPMB - 20MG KETA,TIRANA ORDINARY 0.0
UCMB) CAPSULES CAPSULE
BLISTER
3999 NDA/MAL/H PROFARMA JOINT MEDICAL ERITROMICI ERYTHROMYC 250MG PROFARMA SH.A-MYSLYM ALBANIA ORAL SOLID 1.0X5.0X1 1/13/2020
DP/9175 .SH.A STORE (UPMB - NE IN ESTOLATE KETA,TIRANA ORDINARY 0.0
BLISTER
4000 NDA/MAL/H PROFARMA JOINT MEDICAL PIROCUTAN PIROXICAM 20MG PROFARMA SH.A-MYSLYM ALBANIA ORAL SOLID 1.0X3.0X1 1/13/2020
DP/9176 .SH.A STORE (UPMB - KETA,TIRANA ORDINARY 0.0
BLISTER
4001 NDA/MAL/H PROFARMA JOINT MEDICAL TETRA TETRACYCLIN 1%W/V PROFARMA SH.A-MYSLYM ALBANIA OPHTHALMI 1.0X5.0 G 1/13/2020
DP/9177 .SH.A STORE (UPMB - E KETA,TIRANA C TUBE
UCMB) HYDROCHLOR OINTMENTS
IDE
4002 NDA/MAL/H PROFARMA JOINT MEDICAL LORADE LORATIDINE,L 10MG,10M PROFARMA SH.A-MYSLYM ALBANIA ORAL SOLID 1.0X1.0X1 1/13/2020
DP/9178 .SH.A STORE (UPMB - ORATIDINE G KETA,TIRANA ORDINARY 0.0
BLISTER

National Drug Register of Uganda - Human Medicines - August 2020 PDF

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National Drug Register of Uganda - Human Medicines - August 2020 PDF

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NATIONAL DRUG REGISTER OF UGANDA HUMAN MEDICINES AUGUST 2020

1533 NDA/MAL/H MYLAN KIMSY MEDS LAMIVUDIN LAMIVUDINE 150MG +

2694 NDA/MAL/H CIPLA QUALITY LAMIVIR

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