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 | Drug Name | Applicant | Tentative Approval Date | |
|---|---|---|---|---|
| 1 | 75-830 | MILRINONE LACTATE INJECTION 1 MG (BASE)/ML; 10 ML, 20 ML, AND 50 ML VIALS | FAULDING PHARMACEUTICAL COMPANY | 11/9/01 |
| 2 | 76-182 | OFLOXACIN TABLETS 200 MG, 300 MG, AND 400 MG | TEVA PHARMACEUTICALS USA | 11/23/01 |
| 3 | 75-594 | PAMIDRONATE DISODIUM FOR INJECTION 30 MG/VIAL AND 90 MG/VIAL | AESGEN, INC. | 11/28/01 |
| 4 | 75-863 | DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL TABLETS 0.15 MG/0.02 MG AND 0.01 MG 28-DAY CYCLE | DURAMED PHARMACEUTICALS, INC. | 11/29/01 |
FDA/Center for Drug Evaluation and Research
Last Updated: January 4, 2001
Originator: OGC
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