|
| 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 |
