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U.S. Department of Health and Human Services

Drugs

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Approvals - October 2002

  ANDA Number Generic Drug Name Applicant Approval Date
1 65-069 CEFUROXIME AXETIL TABLETS, USP 250 MG (BASE AND 500 MG (BASE) APOTEX, INC. 10/2/02
2 76-347 TIZANIDINE HYDROCHLORIDE TABLETS 2 MG (BASE4) AND 4 MG (BASE) COREPHARMA LLC 10/11/02
3 75-761 AMIODARONE HYDROCHLORIDE INJECTION 50 MG/ML AMERICAN PHARMACEUTICAL PARTNERS, INC. 10/15/02
4 76-018 AMIODARONE HYDROCHLORIDE INJECTION 50 MG/ML BEDFORD LABORATORIES 10/15/02
5 76-088 AMIODARONE HYDROCHLORIDE INJECTION 50 MG/ML BEN VENUE LABORATORIES, INC. 10/15/02
6 76-108 AMIODARONE HYDROCHLORIDE INJECTION 50 MG/ML FAULDING PHARMACEUTICAL CO. 10/15/02
7 76-217 AMIODARONE HYDROCHLORIDE INJECTION 50 MG/ML BIONICHE PHARMA (CANADA) LTD. 10/15/02
8 75-938 PROPAFENONE HYDROCHLORIDE TABLETS 150 MG, 225 MG, AND 300 MG VINTAGE PHARMACEUTICALS, INC. 10/17/02
9 75-955 AMIODARONE HYDROCHLORIDE INJECTION 50 MG/ML ABBOTT LABORATORIES 10/18/02
10 76-101 FAMOTIDINE TABLETS, USP (OTC) 10 MG EON LABS, INC. 10/21/02
11 76-177 NORETHINDRONE TABLETS, USP 0.35 MG; BLISTER CARDS OF 28 TABLETS BARR LABORATORIES, INC. 10/21/02
12 76-225 NORETHINDRONE TABLETS, USP 0.35 MG; 28 TABLETS PER BLISTER CARD BARR LABORATORIES, INC. 10/21/02
13 40-464 HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP 7.5 MG/325 MG, AND 10 MG/325 MG ABLE LABORATORIES, INC. 10/23/02
14 40-476 HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP 10 MG/650 MG ABLE LABORATORIES, INC. 10/23/02
15 76-299 AMIODARONE HYDROCHLORIDE INJECTION 50 MG/ML, PACKAGED IN 900 MG/18 ML MULTIPLE-DOSE VIALS BEDFORD LABORATORIES 10/24/02
16 40-469 HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP 7.5 MG/750 MG ABLE LABORATORIES, INC. 10/25/02
17 75-474 BISOPROLOL FUMARATE TABLETS 5 MG, AND 10 MG MUTUAL PHARMACEUTICAL COMPANY, INC. 10/25/02
18 40-430 ETHOSUXIMIDE CAPSULES, USP 250 MG BANNER PHARMACAPS, INC. 10/28/02
19 75-882 FLECANIDE ACETATE TABLETS, USP 50 MG, 100 MG, AND 150 MG BARR LABORATORIES, INC. 10/28/02
20 76-030 FLECAINIDE ACETATE TABLETS, USP 50 MG, 100 MG, AND 150 MG GENEVA PHARMACEUTICALS TECHNOLOGY CORP 10/28/02
21 65-096 AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS, USP 875 MG/125 MG (BASE) TEVA PHARMACEUTICALS USA 10/29/02
22 65-101 AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS, USP 500 MG/125 MG (BASE) TEVA PHARMACEUTICALS USA 10/30/02
23 40-365 DEXTROAMPHETAMINE SULFATE TABLETS, USP 5 MG KV PHARMACEUTICAL COMPANY 10/31/02
24 40-367 DEXTROAMPHETAMINE SULFATE TABLETS, USP 10 MG KV PHARMACEUTICAL COMPANY 10/31/02
25 40-468 HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP 10 MG/750 MG MALLINCKRODT, INC. 10/31/02

 

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