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Approvals - November 2002

ANDA Number Generic Drug Name Applicant Approval Date
1 75-410 OMEPRAZOLE DELAYED-RELEASE CAPSULES 10 MG, AND 20 MG KREMERS URBAN DEVELOPMENT COMPANY 11/1/02
2 40-376 EDETATE DISODIUM INJECTION, USP 150 MG/ML; PACKAGED IN 20 ML SINGLE-DOSE VIALS APOTEX CORP. 11/4/02
3 65-109 AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS, USP 500 MG/125 MG (BASE) RANBAXY LABORATORIES LIMITED 11/4/02
4 40-473 HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP 10 MG/500 MG ABLE LABORATORIES, INC. 11/6/02
5 40-477 HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP 5 MG/500 MG ABLE LABORATORIES, INC. 11/6/02
6 76-201 DICLOFENAC SODIUM EXTENDED-RELEASE TABLETS 100 MG DEXCEL LTD. 11/6/02
7 76-329 AMCINONIDE LOTION 0.1% ALTANA INC. 11/6/02
8 40-478 HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP 5 MG/325 MG ABLE LABORATORIES, INC. 11/8/02
9 75-785 OMEPRAZOLE DELAYED-RELEASE CAPSULES 10 MG, AND 20 MG IMPAX LABORATORIES, INC. 11/8/02
10 75-945 ISOTRETINOIN CAPSULES, USP 10 MG, 20 MG, AND 40 MG GENPHARM INC. 11/8/02
11 75-947 GLYBURIDE TABLETS USP (MICRONIZED) 1.5 MG, 3 MG, AND 6 MG AMIDE PHARMACEUTICAL, INC. 11/14/02
12 76-295 VALPROATE SODIUM INJECTION 500 MG/5 ML SINGLE-USE VIAL BEDFORD LABORATORIES 11/14/02
13 75-713 CLOZAPINE TABLETS 25 MG AND 100 MG CARACO PHARMACEUTICAL LABORATORIES, LTD. 11/15/02
14 76-096 AMCINONIDE OINTMENT, USP 0.1% ALTANA INC. 11/19/02
15 65-071 CEFOTAXIME FOR INJECTION, USP 10 G PHARMACY BULK PACKAGE HIKMA FARMACEUTICA (PORTUGAL), LDA. 11/20/02
16 65-072 CEFOTAXIME FOR INJECTION, USP 500 MG, 1 G, AND 2 G VIALS; AND 1 G AND 2 G INFUSION BOTTLES HIKMA FARMACEUTICA (PORTUGAL), LDA. 11/20/02
17 40-471 PROMETHAZINE HYDROCHLORIDE INJECTION, USP 25 MG/ML, PACKAGED IN 10 ML MULTIPLE-DOSE VIALS PHARMAFORCE , INC. 11/21/02
18 65-093 AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS, USP 875 MG/125 MG (BASE) LEK PHARMACEUTICALS, D.D. 11/21/02
19 75-980 TRAMADOL HYDROCHLORIDE TABLETS 50 MG ALPHAPHARM PTY. LTD. 11/21/02
20 76-005 ECONAZOLE NITRATE CREAM 1% TARO PHARMACEUTICALS USA, INC. 11/26/02
21 76-075 ECONAZOLE NITRATE CREAM 1% ALTANA INC. 11/26/02
22 76-399 TIZANIDINE HYDROCHLORIDE TABLETS 2 MG (BASE) EON LABS, INC. 11/26/02
23 65-117 AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS, USP 500 MG/125 MG (BASE) LEK PHARMACEUTICALS D.D. 11/27/02
24 75-769 DIPYRIDAMOLE INJECTION 5 MG/ML (PACKAGED IN 10 MG/2 ML & 50 MG/10 ML SINGLE-USE VIALS APOTEX CORP. 11/27/02
25 76-061 PERGOLIDE MESYLATE TABLETS 0.05 MG (BASE), 0.25 MG (BASE), AND 1 MG (BASE) TEVA PHARMACEUTICALS USA 11/27/02
26 76-322 FAMOTIDINE INJECTION (PRESERVATIVE-FREE) 10 MG/ML PACKAGED IN 500 MG/50 ML PHARMACY BULK PACKAGES APOTEX CORP. 11/27/02
27 76-324 FAMOTIDINE INJECTION (PRESERVATIVE-FREE) 10 MG/ML (PACKAGED IN 20 MG/2 ML SINGLE-USE VIALS) APOTEX CORP. 11/27/02
28 65-113 AMOXICILLIN FOR ORAL SUSPENSION, USP 200 MG/5 ML AND 400 MG/5 ML RANBAXY LABORATORIES LIMITED 11/29/02
29 65-120 TOBRAMYCIN INJECTION, USP (PHARMACY BULK PACKAGE) 40 MG/ML, PACKAGED IN 2 G/50 ML VIALS AMERICAN PHARMACEUTICAL PARTNERS, INC. 11/29/02
30 65-122 TOBRAMYCIN INJECTION, USP 10 MG/ML (20 MG/2 ML MULTIPLE- DOSE VIALS); AND 40 MG/ML (80 MG/2 ML MULTIPLE-DOSE VIALS) AMERICAN PHARMACEUTICAL PARTNERS, INC. 11/29/02
31 76-185 DIMETHYL SULFOXIDE IRRIGATION, USP 50% BIONICHE PHARMA (CANADA) LTD. 11/29/02
32 76-362 AMIODARONE HYDROCHLORIDE TABLETS 400 MG TARO PHARMACEUTICAL INDUSTRIES, LTD. 11/29/02

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Last Updated: December 10, 2002
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