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U.S. Department of Health and Human Services

Drugs

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Approvals - October 2002

 ANDA NumberGeneric Drug NameApplicantApproval Date
165-069CEFUROXIME AXETIL TABLETS, USP 250 MG (BASE AND 500 MG (BASE)APOTEX, INC.10/2/02
276-347TIZANIDINE HYDROCHLORIDE TABLETS 2 MG (BASE4) AND 4 MG (BASE)COREPHARMA LLC10/11/02
375-761AMIODARONE HYDROCHLORIDE INJECTION 50 MG/MLAMERICAN PHARMACEUTICAL PARTNERS, INC.10/15/02
476-018AMIODARONE HYDROCHLORIDE INJECTION 50 MG/MLBEDFORD LABORATORIES10/15/02
576-088AMIODARONE HYDROCHLORIDE INJECTION 50 MG/MLBEN VENUE LABORATORIES, INC.10/15/02
676-108AMIODARONE HYDROCHLORIDE INJECTION 50 MG/MLFAULDING PHARMACEUTICAL CO.10/15/02
776-217AMIODARONE HYDROCHLORIDE INJECTION 50 MG/MLBIONICHE PHARMA (CANADA) LTD.10/15/02
875-938PROPAFENONE HYDROCHLORIDE TABLETS 150 MG, 225 MG, AND 300 MGVINTAGE PHARMACEUTICALS, INC.10/17/02
975-955AMIODARONE HYDROCHLORIDE INJECTION 50 MG/MLABBOTT LABORATORIES10/18/02
1076-101FAMOTIDINE TABLETS, USP (OTC) 10 MGEON LABS, INC.10/21/02
1176-177NORETHINDRONE TABLETS, USP 0.35 MG; BLISTER CARDS OF 28 TABLETSBARR LABORATORIES, INC.10/21/02
1276-225NORETHINDRONE TABLETS, USP 0.35 MG; 28 TABLETS PER BLISTER CARDBARR LABORATORIES, INC.10/21/02
1340-464HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP 7.5 MG/325 MG, AND 10 MG/325 MGABLE LABORATORIES, INC.10/23/02
1440-476HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP 10 MG/650 MGABLE LABORATORIES, INC.10/23/02
1576-299AMIODARONE HYDROCHLORIDE INJECTION 50 MG/ML, PACKAGED IN 900 MG/18 ML MULTIPLE-DOSE VIALSBEDFORD LABORATORIES10/24/02
1640-469HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP 7.5 MG/750 MGABLE LABORATORIES, INC.10/25/02
1775-474BISOPROLOL FUMARATE TABLETS 5 MG, AND 10 MGMUTUAL PHARMACEUTICAL COMPANY, INC.10/25/02
1840-430ETHOSUXIMIDE CAPSULES, USP 250 MGBANNER PHARMACAPS, INC.10/28/02
1975-882FLECANIDE ACETATE TABLETS, USP 50 MG, 100 MG, AND 150 MGBARR LABORATORIES, INC.10/28/02
2076-030FLECAINIDE ACETATE TABLETS, USP 50 MG, 100 MG, AND 150 MGGENEVA PHARMACEUTICALS TECHNOLOGY CORP10/28/02
2165-096AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS, USP 875 MG/125 MG (BASE)TEVA PHARMACEUTICALS USA10/29/02
2265-101AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS, USP 500 MG/125 MG (BASE)TEVA PHARMACEUTICALS USA10/30/02
2340-365DEXTROAMPHETAMINE SULFATE TABLETS, USP 5 MGKV PHARMACEUTICAL COMPANY10/31/02
2440-367DEXTROAMPHETAMINE SULFATE TABLETS, USP 10 MGKV PHARMACEUTICAL COMPANY10/31/02
2540-468HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP 10 MG/750 MGMALLINCKRODT, INC.10/31/02