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 |
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| ANDA Number | Generic Drug Name | Applicant | Tentative Approval Date | |
|---|---|---|---|---|
| 1 | 76-226 | TORSEMIDE TABLETS 5 MG, 10 MG, 20 MG, AND 100 MG | PAR PHARMACEUTICAL, INC. | 11/4/02 |
| 2 | 75-785 | OMEPRAZOLE DELAYED-RELEASE CAPSULES 40 MG | IMPAX LABORATORIES, INC. | 11/8/02 |
| 3 | 75-990 | LORATADINE ORALLY DISINTEGRATING TABLETS 10 MG | ANDRX PHARMACEUTICALS, INC. | 11/15/02 |
FDA/Center for Drug Evaluation and Research
Last Updated: December 10, 2002
Originator: OTCOM/DLIS
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