U.S. Food and Drug Administration • Center for Drug Evaluation
and Research |
U.S. Food and Drug Administration • Center for Drug Evaluation
and Research |
 |
Drug Information |
| ANDA Number | DRUG NAME | APPLICANT | Approval DATE | |
| 1 | 40-295 | HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE TABLETS 5 MG/1.5 MG | AMIDE PHARMACEUTICAL, INC. | 12/1/00 |
| 2 | 65-055 | DOXYCYCLINE CAPSULES USP, 50 MG, 100 MG | PAR PHARMACEUTICAL, INC. | 12/1/00 |
| 3 | 75-384 | TERAZOSIN HYDROCHLORIDE CAPSULES, 1 MG (BASE), 2 MG (BASE), 5 mg (BASE), 10 mg (BASE) | MYLAN TECHNOLOGIES, INC. | 12/1/00 |
| 4 | 75-269 | NIFEDIPINE EXTENDED-RELEASE TABLETS USP, 30 MG, 60 MG | BIOVAIL LABORATORIES, INC. | 12/4/00 |
| 5 | 75-117 | PREDNISOLONE SODIUM PHOSPHATE ORAL SOLUTION, 15 MG (BASE)/5 ML | ASCENT PEDIATRICS, INC. | 12/14/00 |
| 6 | 65-070 | DOXYCYCLINE TABLETS, 50 MG, 100 MG | PAR PHARMACEUTICAL, INC. | 12/15/00 |
| 7 | 75-379 | VALPROIC ACID SYRUP USP, 250 MG/5 ML | PHARMACEUTICAL ASSOCIATES, INC. | 12/15/00 |
| 8 | 75-725 | SOTALOL HYDROCHLORIDE TABLETS, 80 MG, 120 MG, 160 MG, 240 MG | MYLAN PHARMACEUTICALS, INC. | 12/19/00 |
| 9 | 65-044 | CYCLOSPORINE CAPSULES USP, (MODIFIED), 25 MG, 100 MG | SIDMAK LABORATORIES, INC. | 12/20/00 |
| 10 | 75-585 | CROMOLYN SODIUM INHALATION SOLUTION USP, 10 MG/ML | BAUSCH LOMB PHARMACEUTICALS, INC. | 12/21/00 |
| 11 | 75-875 | CARBAMAZEPINE ORAL SUSPENSION USP, 100 MG/5 ML | TARO PHARMACEUTICAL INDUSTRIES, LTD. | 12/21/00 |
| 12 | 75-782 | VALPROIC ACID SYRUP USP, 250 MG/ 5 ML | UDL LABORATORIES, INC. | 12/22/00 |
| 13 | 75-642 | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLETS, 2.5 MG/6.25 MG, 5 MG/6.25 MG, 10 MG/6.25 MG | APOTHECON, INC. | 12/27/00 |
| 14 | 75-901 | FLUVOXAMINE MALEATE TABLETS, 25 MG, 50 MG, 100 MG | PUREPAC PHARMACEUTICAL CO. | 12/28/00 |
| 15 | 40-310 | HYDROCORTISONE OINTMENT USP, 2.5% | THAMES PHARMACAL CO., INC. | 12/29/00 |
| 16 | 40-371 | OXYCODONE AND ACETAMINOPHEN TABLETS USP, 7.5 MG/ 500 MG, 10 MG/ 650 MG | WATSON LABORATORIES, INC. | 12/29/00 |
| 17 | 75-363 | CLOBETASOL PROPIONATE TOPICAL SOLUTION USP, 0.05% | THAMES PHARMACAL CO., INC. | 12/29/00 |
FDA/Center for Drug Evaluation and Research
Last Updated: March 08, 2001
Originator: OGC
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