Approvals - May 2001
| |
ANDA Number |
Drug Name |
Applicant |
Approval Date |
| 1 |
75-902 |
FLUVOXAMINE MALEATE TABLETS 25 MG, 50 MG, AND 100 MG |
TORPHARM |
5/7/01 |
| 2 |
76-032 |
METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS, USP 20 MG |
ABLE LABORATORIES, INC. |
5/9/01 |
| 3 |
75-591 |
FAMOTIDINE INJECTION (PRESERVATIVE-FREE) 0.4 MG/ML (20 MG/50 ML)
SINGLE-DOSE IN GALAXY PLASTIC CONTAINER. |
BAXTER HEALTHCARE CORPORATION |
5/10/01 |
| 4 |
75-607 |
FAMOTIDINE TABLETS, USP 20 MG, AND 40 MG |
INVAMED INC. |
5/10/01 |
| 5 |
75-602 |
AMINOCAPROIC ACID TABLETS, USP 500 MG |
MIKART, INC. |
5/24/01 |
| 6 |
40-360 |
PERPHENAZINE ORAL SOLUTION, USP 16 MG/5 ML (CONCENTRATE) |
PHARMACEUTICAL ASSOCIATES, INC. |
5/25/01 |
| 7 |
75-951 |
NORETHINDRONE ACETATE TABLETS, USP 5 MG |
BARR LABORATORIES, INC. |
5/25/01 |
| 8 |
75-673 |
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM, USP 1%/0.05% (BASE) |
TARO PHARMACEUTICALS U.S.A., INC. |
5/29/01 |
| 9 |
65-001 |
CEFUROXIME FOR INJECTION, USP 750 MG/10 ML (VIAL);
1.5 G/20 ML (VIAL); 750 MG/100 ML (INFUSION BOTTLE); AND 1.5 G/100 ML (INFUSION BOTTLE). |
AMERICAN PHARMACEUTICAL PARTNERS, INC. |
5/30/01 |
| 10 |
40-419 |
ACETAMINOPHEN AND CODEINE TABLETS, USP 300 MG/15 MG,
300 MG/30 MG, AND 300 MG/60 MG. |
MALLINCKRODT, INC. |
5/31/01 |
| 11 |
75-312 |
FAMOTIDINE TABLETS, USP 10 MG (OVER-THE COUNTER USE) |
TEVA PHARMACEUTICALS, USA |
5/31/01 |
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Last Updated: June 14, 200125 Apr 2006 08:52:09 -0400
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