Drugs
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Approvals April 2001
| ANDA Number | Drug Name | Applicant | Approval Date | |
|---|---|---|---|---|
| 1 | 75-547 | THIOTEPA FOR INJECTION, USP 15 MG/VIAL | BEDFORD LABORATORIES | 4/2/01 |
| 2 | 75-498 | TERAZOSIN HYDROCHLORIDE CAPSULES 1 MG (BASE) 2 MG (BASE) 5 MG (BASE) 10 MG (BASE) | TORPHARM | 4/12/01 |
| 3 | 75-630 | BETAXOLOL OPHTHALMIC SOLUTION, USP 0.5% (5 ML, 10 ML, & 15 ML) | BAUSCH & LOMB PHARMACEUTICALS, INC. | 4/12/01 |
| 4 | 75-842 | OXAPROZIN TABLETS 600 MG | INVAMED, INC. | 4/12/01 |
| 5 | 75-062 | FAMOTIDINE TABLETS, USP 20 MG 40 MG | DANBURY PHARMACAL, INC. | 4/16/01 |
| 6 | 75-302 | FAMOTIDINE TABLETS, USP 20 MG 40 MG | GENEVA PHARMACEUTICALS, INC. | 4/16/01 |
| 7 | 75-311 | FAMOTIDINE TABLETS, USP 20 MG 40 MG | TEVA PHARMACEUTICALS USA | 4/16/01 |
| 8 | 75-486 | FAMOTIDINE INJECTION (PRESERVATIVE-FREE) 10 MG/ML (20 MG/2 ML) VIALS | ESI LEDERLE | 4/16/01 |
| 9 | 75-488 | FAMOTIDINE INJECTION 10 MG/ML (MULTIPLE-DOSE VIALS) | ESI LEDERLE | 4/16/01 |
| 10 | 75-511 | FAMOTIDINE TABLETS, USP 20 MG 40 MG | ZENITH GOLDLINE PHARMACEUTICALS, INC. | 4/16/01 |
| 11 | 75-622 | FAMOTIDINE INJECTION (PRESERVATIVE-FREE) 10 MG/ML (20 MG/2 ML VIALS) | BEDFORD LABORATORIES | 4/16/01 |
| 12 | 75-651 | FAMOTIDINE INJECTION 10 MG/ML (MULTIPLE-DOSE VIALS) | BEDFORD LABORATORIES | 4/16/01 |
| 13 | 75-669 | FAMOTIDINE INJECTION (PRESERVATIVE-FREE) 10 MG/ML (20 MG/2 ML) VIALS | FAULDING PHARMACEUTICAL COMPANY | 4/16/01 |
| 14 | 75-684 | FAMOTIDINE INJECTION 10 MG/ML (500 MG/50 ML) PHARMACY BULK PACKAGE | BEDFORD LABORATORIES | 4/16/01 |
| 15 | 75-704 | FAMOTIDINE TABLETS, USP 20 MG 40 MG | MYLAN PHARMACEUTICALS, INC. | 4/16/01 |
| 16 | 75-705 | FAMOTIDINE INJECTION 10 MG/ML (MULTIPLE-DOSE VIALS) | FAULDING PHARMACEUTICAL COMPANY | 4/16/01 |
| 17 | 75-707 | FAMOTIDINE INJECTION 10 MG/ML (MULTIPLE-DOSE VIALS) | APOTHECON INC. | 4/16/01 |
| 18 | 75-708 | FAMOTIDINE INJECTION (PRESERVATIVE-FREE) 10 MG/ML (20 MG/2 ML) VIALS | APOTHECON INC. | 4/16/01 |
| 19 | 75-709 | FAMOTIDINE INJECTION 10 MG/ML (MULTIPLE-DOSE VIALS) | AMERICAN PHARMACEUTICAL PARTNERS, INC. | 4/16/01 |
| 20 | 75-718 | FAMOTIDINE TABLETS, USP 20 MG 40 MG | DR. REDDY'S LABORATORIES LIMITED | 4/16/01 |
| 21 | 75-786 | FAMOTIDINE TABLETS, USP 20 MG 40 MG | WOCKHARDT AMERICAS, INC. | 4/16/01 |
| 22 | 75-793 | FAMOTIDINE TABLETS, USP 20 MG 40 MG | EON LABS MANUFACTURING, INC. | 4/16/01 |
| 23 | 75-805 | FAMOTIDINE TABLETS, USP 20 MG 40 MG | CARLSBAD TECHNOLOGY, INC. | 4/16/01 |
| 24 | 75-813 | FAMOTIDINE INJECTION (PRESERVATIVE-FREE) 10 MG/ML (20 MG/2 ML) VIALS | AMERICAN PHARMACEUTICAL PARTNERS, INC. | 4/16/01 |
| 25 | 74-567 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLETS, USP 200 MG/30 MG | OHM LABORATORIES, INC. | 4/17/01 |
| 26 | 75-825 | FAMOTIDINE INJECTION (PRESERVATIVE-FREE) 10 MG/ML (500 MG/50 ML) PHARMACY BULK PACKAGE | BEN VENUE LABORATORIES, INC. | 4/17/01 |
| 27 | 75-457 | FAMOTIDINE TABLETS, USP 20 MG 40 MG | GENPHARM INC. | 4/18/01 |
| 28 | 75-894 | FLUVOXAMINE MALEATE TABLETS 25 MG, 50 MG, AND 100 MG | WATSON LABORATORIES, INC. | 4/18/01 |
| 29 | 75-390 | NAPROXEN DELAYED RELEASE TABLETS 375 MG 500 MG | ALPHAPHARM PTY. LTD. | 4/19/01 |
| 30 | 75-730 | THIOTEPA FOR INJECTION, USP 15 MG/VIAL 30 MG/VIAL | GENSIA SICOR PHARMACEUTICALS, INC. | 4/20/01 |
| 31 | 75-906 | PROGESTERONE INJECTION, USP 50 MG/ML (MULTIPLE-DOSE VIAL) | AMERICAN PHARMACEUTICAL PARTNERS, INC. | 4/25/01 |
| 32 | 75-811 | MESNA INJECTION 100 MG/ML; (10 ML MULTIPLE-DOSE VIAL) | AMERICAN PHARMACEUTICAL PARTNERS, INC. | 4/26/01 |
| 33 | 75-058 | FLURBIPROFEN TABLETS, USP 50 MG 100 MG | CARACO PHARMACEUTICAL LABORATORIES, LTD. | 4/27/01 |
| 34 | 75-423 | CLONAZEPAM TABLETS, USP 0.5 MG, 1 MG, AND 2 MG | CARACO PHARMACEUTICAL LABORATORIES, LTD. | 4/27/01 |
| 35 | 75-500 | SOTALOL HYDROCHLORIDE TABLETS 80 MG 120 MG 160 MG 240 MG | UPSHER-SMITH LABORATORIES, INC. | 4/27/01 |
| 36 | 75-764 | MESNA INJECTION 100 MG/ML (10 ML MULTIPLE-DOSE VIAL) | GENSIA SICOR PHARMACEUTICALS, INC. | 4/27/01 |
| 37 | 75-850 | OXAPROZIN TABLETS 600 MG | GENEVA PHARMACEUTICALS, INC. | 4/27/01 |
| 38 | 75-290 | PAMIDRONATE DISODIUM FOR INJECTION 30 MG/VIAL, AND 90 MG/VIAL | BEDFORD LABORATORIES | 4/30/01 |
| 39 | 75-796 | LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS, USP 0.1 MG/0.02 MG, RESPECTIVELY; (21-DAY AND 28-DAY CYCLES) | DURAMED PHARMACEUTICALS, INC. | 4/30/01 |
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