| |
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 |
