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U.S. Department of Health and Human Services

Drugs

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Approvals - November 2002

 ANDA NumberGeneric Drug NameApplicantApproval Date
175-410OMEPRAZOLE DELAYED-RELEASE CAPSULES 10 MG, AND 20 MGKREMERS URBAN DEVELOPMENT COMPANY11/1/02
240-376EDETATE DISODIUM INJECTION, USP 150 MG/ML; PACKAGED IN 20 ML SINGLE-DOSE VIALSAPOTEX CORP.11/4/02
365-109AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS, USP 500 MG/125 MG (BASE)RANBAXY LABORATORIES LIMITED11/4/02
440-473HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP 10 MG/500 MGABLE LABORATORIES, INC.11/6/02
540-477HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP 5 MG/500 MGABLE LABORATORIES, INC.11/6/02
676-201DICLOFENAC SODIUM EXTENDED-RELEASE TABLETS 100 MGDEXCEL LTD.11/6/02
776-329AMCINONIDE LOTION 0.1%ALTANA INC.11/6/02
840-478HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP 5 MG/325 MGABLE LABORATORIES, INC.11/8/02
975-785OMEPRAZOLE DELAYED-RELEASE CAPSULES 10 MG, AND 20 MGIMPAX LABORATORIES, INC.11/8/02
1075-945ISOTRETINOIN CAPSULES, USP 10 MG, 20 MG, AND 40 MGGENPHARM INC.11/8/02
1175-947GLYBURIDE TABLETS USP (MICRONIZED) 1.5 MG, 3 MG, AND 6 MGAMIDE PHARMACEUTICAL, INC.11/14/02
1276-295VALPROATE SODIUM INJECTION 500 MG/5 ML SINGLE-USE VIALBEDFORD LABORATORIES11/14/02
1375-713CLOZAPINE TABLETS 25 MG AND 100 MGCARACO PHARMACEUTICAL LABORATORIES, LTD.11/15/02
1476-096AMCINONIDE OINTMENT, USP 0.1%ALTANA INC.11/19/02
1565-071CEFOTAXIME FOR INJECTION, USP 10 G PHARMACY BULK PACKAGEHIKMA FARMACEUTICA (PORTUGAL), LDA.11/20/02
1665-072CEFOTAXIME FOR INJECTION, USP 500 MG, 1 G, AND 2 G VIALS; AND 1 G AND 2 G INFUSION BOTTLESHIKMA FARMACEUTICA (PORTUGAL), LDA.11/20/02
1740-471PROMETHAZINE HYDROCHLORIDE INJECTION, USP 25 MG/ML, PACKAGED IN 10 ML MULTIPLE-DOSE VIALSPHARMAFORCE , INC.11/21/02
1865-093AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS, USP 875 MG/125 MG (BASE)LEK PHARMACEUTICALS, D.D.11/21/02
1975-980TRAMADOL HYDROCHLORIDE TABLETS 50 MGALPHAPHARM PTY. LTD.11/21/02
2076-005ECONAZOLE NITRATE CREAM 1%TARO PHARMACEUTICALS USA, INC.11/26/02
2176-075ECONAZOLE NITRATE CREAM 1%ALTANA INC.11/26/02
2276-399TIZANIDINE HYDROCHLORIDE TABLETS 2 MG (BASE)EON LABS, INC.11/26/02
2365-117AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS, USP 500 MG/125 MG (BASE)LEK PHARMACEUTICALS D.D.11/27/02
2475-769DIPYRIDAMOLE INJECTION 5 MG/ML (PACKAGED IN 10 MG/2 ML & 50 MG/10 ML SINGLE-USE VIALSAPOTEX CORP.11/27/02
2576-061PERGOLIDE MESYLATE TABLETS 0.05 MG (BASE), 0.25 MG (BASE), AND 1 MG (BASE)TEVA PHARMACEUTICALS USA11/27/02
2676-322FAMOTIDINE INJECTION (PRESERVATIVE-FREE) 10 MG/ML PACKAGED IN 500 MG/50 ML PHARMACY BULK PACKAGESAPOTEX CORP.11/27/02
2776-324FAMOTIDINE INJECTION (PRESERVATIVE-FREE) 10 MG/ML (PACKAGED IN 20 MG/2 ML SINGLE-USE VIALS)APOTEX CORP.11/27/02
2865-113AMOXICILLIN FOR ORAL SUSPENSION, USP 200 MG/5 ML AND 400 MG/5 MLRANBAXY LABORATORIES LIMITED11/29/02
2965-120TOBRAMYCIN INJECTION, USP (PHARMACY BULK PACKAGE) 40 MG/ML, PACKAGED IN 2 G/50 ML VIALSAMERICAN PHARMACEUTICAL PARTNERS, INC.11/29/02
3065-122TOBRAMYCIN 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
3176-185DIMETHYL SULFOXIDE IRRIGATION, USP 50%BIONICHE PHARMA (CANADA) LTD.11/29/02
3276-362AMIODARONE HYDROCHLORIDE TABLETS 400 MGTARO PHARMACEUTICAL INDUSTRIES, LTD.11/29/02