Tentative Approvals - May 2001
|
ANDA Number |
Drug Name |
Applicant |
Tentative Approval Date |
1 |
75-410 |
OMEPRAZOLE DELAYED-RELEASE CAPSULES 10 MG, AND 20 MG |
KREMERS URBAN DEVELOPMENT COMPANY |
5/3/01 |
2 |
75-521 |
BUSPIRONE HYDROCHLORIDE TABLETS USP 5 MG, 10 MG, AND 15 MG |
TORPHARM |
5/9/01 |
3 |
75-690 |
FLUOXETINE ORAL SOLUTION, USP 20 MG/5 ML |
ALPHARMA, U.S. PHARMACEUTICALS DIVISION |
5/10/01 |
4 |
75-762 |
OFLOXACIN INJECTION 40 MG/ML (10 ML SINGLE-DOSE VIAL) |
BEDFORD LABORATORIES |
5/23/01 |
5 |
75-356 |
PAROXETINE HYDROCHLORIDE TABLETS 10 MG, 20 MG, 30 MG, AND 40 MG |
TORPHARM |
5/24/01 |
6 |
75-994 |
LISINOPRIL TABLETS, USP 2.5 MG, 5 MG, 10 MG, 20 MG, 30 MG, AND 40 MG |
EON LABS MANUFACTURING, INC. |
5/24/01 |
7 |
75-939 |
CIPROFLOXACIN TABLETS, USP 100 MG, 250 MG, 500 MG, AND 750 MG |
GENEVA PHARMACEUTICALS, INC. |
5/30/01 |
8 |
75-112 |
DIVALPROEX SODIUM DELAYED-RELEASE TABLETS, USP EQUIVALENT TO 125 MG, 250 MG, AND 500 MG VALPROIC ACID |
TORPHARM |
5/31/01 |
9 |
75-872 |
FLUOXETINE HYDROCHLORIDE TABLETS 10 MG (BASE) |
TEVA PHARMACEUTICALS USA |
5/31/01 |
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Last Updated: September 10, 200125 Apr 2006 08:48:52 -0400
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