U.S. Food and Drug Administration • Center for Drug Evaluation
and Research |
U.S. Food and Drug Administration • Center for Drug Evaluation
and Research |
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Drug Information |
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| ANDA Number | Drug Name | Applicant | Tentative Approval Date | |
|---|---|---|---|---|
| 1 | 76-093 | OFLOXACIN TABLETS 200 MG 300 MG 400 MG | PAR PHARMACEUTICAL, INC | 12/5/01 |
| 2 | 75-752 | LISINOPRIL TABLETS, USP 2.5 MG, 5 MG, 10 MG, 20 MG, 30 MG, AND 40 MG | ZENITH GOLDLINE PHARMACEUTICALS, INC. | 12/19/01 |
| 3 | 75-999 | LISINOPRIL TABLETS, USP 2.5 MG, 5 MG, 10 MG, 20 MG, 30 MG 40 MG | LEK PHARMACEUTICAL AND CHEMICAL CO. d.d. | 12/19/01 |
| 4 | 76-134 | LORATADINE TABLETS 10 MG | RANBAXY LABORATORIES LIMITED | 12/20/01 |
| 5 | 76-058 | MIDAZOLAM HYDROCHLORIDE SYRUP 2 MG (BASE)/ML | RANBAXY LABORATORIES, LTD. | 12/21/01 |
| 6 | 76-136 | CIPROFLOXACIN TABLETS, USP 250 MG, 500 MG, AND 750 MG | TEVA PHARMACEUTICALS USA | 12/26/01 |
FDA/Center for Drug Evaluation and Research
Last Updated: January 4, 2001
Originator: OGC
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