Drugs
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Approvals - June 2001
| ANDA Number | Drug Name | Applicant | Approval Date | |
|---|---|---|---|---|
| 1 | 40-374 | TRIAMCINOLONE ACETONIDE OINTMENT, USP 0.025% | THAMES PHARMACAL CO., INC. | 6/5/01 |
| 2 | 40-386 | TRIAMCINOLONE ACETONIDE OINTMENT, USP 0.5% | THAMES PHARMACAL CO., INC. | 6/5/01 |
| 3 | 75-502 | CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM, USP 1%/0.05% (BASE) | ALTANA INC. | 6/5/01 |
| 4 | 75-750 | DOXAZOSIN MESYLATE TABLETS 1 MG (BASE), 2 MG (BASE), 4 MG (BASE), AND 8 MG (BASE) | SIDMAK LABORATORIES, INC. | 6/8/01 |
| 5 | 75-598 | MINOXIDIL TOPICAL SOLUTION, USP (FOR MEN) 5% | L. PERRIGO COMPANY | 6/13/01 |
| 6 | 75-795 | GLIPIZIDE TABLETS, USP 5 MG AND 10 MG | TORPHARM | 6/13/01 |
| 7 | 75-300 | LOVASTATIN TABLETS, USP 10 MG, 20 MG, AND 40 MG | GENEVA PHARMACEUTICALS, INC. | 6/15/01 |
| 8 | 75-451 | LOVASTATIN TABLETS, USP 10 MG, 20 MG, AND 40 MG | MYLAN PHARMACEUTICALS, INC. | 6/15/01 |
| 9 | 75-551 | LOVASTATIN TABLETS, USP 10 MG, 20 MG, AND 40 MG | TEVA PHARMACEUTICALS USA | 6/15/01 |
| 10 | 75-636 | LOVASTATIN TABLETS, USP 10 MG, 20 MG, AND 40 MG | EON LABS MANUFACTURING, INC. | 6/15/01 |
| 11 | 75-812 | DACARBAZINE FOR INJECTION, USP 200 MG/VIAL | BEDFORD LABORATORIES | 6/15/01 |
| 12 | 75-935 | LOVASTATIN TABLETS, USP 10 MG, 20 MG, AND 40 MG | GENPHARM INC. | 6/15/01 |
| 13 | 75-858 | HALOPERIDOL INJECTION, USP 5 MG/ML | BEDFORD LABORATORIES | 6/18/01 |
| 14 | 40-421 | CARISOPRODOL TABLETS, USP 350 MG | ABLE LABORATORIES, INC. | 6/21/01 |
| 15 | 75-861 | LEVOCARNITINE INJECTION, USP 200 MG/ML (500 MG/2.5 ML & 1G/5 ML SINGLE-DOSE VIALS). | LUITPOLD PHARMACEUTICALS, INC. | 6/22/01 |
| 16 | 75-644 | BISOPROLOL FUMARATE TABLETS 5 MG, AND 10 MG | COPLEY PHARMACEUTICAL, INC. | 6/26/01 |
| 17 | 75-664 | ALBUTEROL SULFATE INHALATION SOLUTION 0.5% (BASE), PACKAGED IN 2.5 MG/0.5 ML UNIT-OF-USE VIALS | NEPHRON PHARMACEUTICALS CORPORATION | 6/26/01 |
| 18 | 75-877 | TERBUTALINE SULFATE TABLETS, USP 2.5 MG, AND 5 MG | IMPAX LABORATORIES, INC. | 6/26/01 |
| 19 | 40-418 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN ORAL SOLUTION 7.5 MG AND 500 MG, RESPECTIVELY, PER 15 ML. | MALLINCKRODT, INC. | 6/27/01 |
| 20 | 76-008 | BUSPIRONE HYDROCHLORIDE TABLETS, USP 30 MG | MYLAN TECHNOLOGIES, INC. | 6/28/01 |
| 21 | 65-027 | CLINDAMYCIN IN 5% DEXTROSE INJECTION 300 MG/50 ML (6 MG/ML), 600 MG/50 ML (12 MG/ML), AND 900 MG/50 ML (18 MG/ML) | ABBOTT LABORATORIES | 6/29/01 |
| 22 | 75-631 | KETOROLAC TROMETHAMINE INJECTION, USP 15 MG/ML (1 ML SINGLE-DOSE VIAL); AND 30 MG/ML (1 ML & 2 ML SINGLE-DOSE VIALS) | APOTEX CORP. | 6/29/01 |
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