Tentative Approvals - June 2001
|
ANDA Number |
Drug Name |
Applicant |
Tentative Approval Date |
1 |
75-727 |
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLETS, USP 5 MG/12.5 MG, AND 10 MG/25 MG |
TEVA PHARMACEUTICALS USA |
6/8/01 |
2 |
75-743 |
LISINOPRIL TABLETS, USP 2.5 MG, 5 MG, 10 MG, 20 MG, 30 MG, AND 40 MG |
PAR PHARMACEUTICAL, INC. |
6/22/01 |
3 |
75-576 |
OMEPRAZOLE DELAYED-RELEASE CAPSULES 40 MG |
DR. REDDY'S LABORATORIES LIMITED |
6/25/01 |
4 |
75-465 |
FLUOXETINE CAPSULES, USP 10 MG, 20 MG, AND 40 MG |
DR. REDDY'S LABORATORIES LIMITED |
6/26/01 |
5 |
75-775 |
POTASSIUM CHLORIDE EXTENDED-RELEASE TABLETS, USP 10 mEq, AND 20 mEq |
ELAN PHARMACEUTICAL RESEARCH CORPORATION |
6/28/01 |
6 |
75-755 |
FLUOXETINE HYDROCHLORIDE TABLETS 10 MG (BASE) 20 MG (BASE) |
ALPHAPHARM PTY. LTD. |
6/29/01 |
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Last Updated: September 10, 200125 Apr 2006 08:49:06 -0400
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