Drug Information |
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 |
FDA/Center for Drug Evaluation and Research
Last Updated: November 6, 2002
Originator: OTCOM/OGD
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