U.S. Food and Drug Administration • Center for Drug Evaluation
and Research |
U.S. Food and Drug Administration • Center for Drug Evaluation
and Research |
 |
Drug Information |
 |
| ANDA Number | Drug Name | Applicant | Tentative Approval Date | |
|---|---|---|---|---|
| 1 | 76-071 | LISINOPRIL TABLETS, USP 2.5 MG, 5 MG, 10 MG, 20 MG, 30 MG, AND 40 MG | MYLAN PHARMACEUTICALS INC. | 9/10/01 |
| 2 | 75-807 | FLUOXETINE CAPSULES, USP 10 MG, AND 20 MG | EON LABS MANUFACTURING, INC. | 9/12/01 |
| 3 | 76-024 | FLUOXETINE HYDROCHLORIDE TABLETS 10 MG (BASE) | EON LABS MANUFACTURING, INC. | 9/12/01 |
| 4 | 76-101 | FAMOTIDINE TABLETS, USP (OTC) 10 MG | EON LABS MANUFACTURING, INC. | 9/14/01 |
| 5 | 75-662 | FLUOXETINE CAPSULES, USP 10 MG, AND 20 MG | CHELSEA LABORATORIES, INC. | 9/17/01 |
| 6 | 75-920 | FLUOXETINE ORAL SOLUTION, USP 20 MG/5 ML | MALLINCKRODT, INC. | 9/28/01 |
| 7 | 75-934 | NIZATIDINE CAPSULES, USP 150 MG, AND 300 MG | GENPHARM INC. | 9/28/01 |
FDA/Center for Drug Evaluation and Research
Last Updated: November 16, 200125 Apr 2006 08:49:51 -0400
Originator: OGC
HTML by PKS, TA
