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 | Approval Date | |
|---|---|---|---|---|
| 1 | 75-521 | BUSPIRONE HYDROCHLORIDE TABLETS, USP 5 MG, 10 MG, AND 15 MG | TORPHARM | 4/5/02 |
| 2 | 75-863 | DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL TABLETS 0.15 MG/0.02 MG AND 0.01 MG RESPECTIVELY (28-DAY CYCLE) | BARR LABORATORIES, INC. | 4/5/02 |
| 3 | 76-044 | POTASSIUM CHLORIDE EXTENDED-RELEASE TABLETS, USP 20 mEq (1500 mg) | KV PHARMACEUTICAL COMPANY | 4/5/02 |
| 4 | 75-588 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLETS, USP 200 MG AND 30 MG, RESPECTIVELY (OTC); (ROUND AND CAPSULE-SHAPED TABLETS) | PHARMACEUTICAL FORMULATIONS, INC. | 4/8/02 |
| 5 | 75-753 | FENOFIBRATE CAPSULES (MICRONIZED) 134 MG AND 200 MG | NOVOPHARM LIMITED | 4/9/02 |
| 6 | 40-364 | PREDNISOLONE SYRUP, USP 15 MG/5 ML | KV PHARMACEUTICAL COMPANY | 4/10/02 |
| 7 | 40-391 | HYDROXYZINE HYDROCHLORIDE SYRUP, USP 10 MG/5 ML | VINTAGE PHARMACEUTICALS, INC. | 4/10/02 |
| 8 | 75-604 | POTASSIUM CHLORIDE EXTENDED-RELEASE TABLETS, USP 10 mEq (750 MG) AND 20 mEq (1500 MG) | ANDRX PHARMACEUTICALS, INC. | 4/10/02 |
| 9 | 76-141 | CLOBETASOL PROPIONATE GEL 0.05% | HEALTHPOINT, LTD. | 4/12/02 |
| 10 | 40-297 | ESTRADIOL TABLETS, USP 0.5 MG, 1 MG, AND 2 MG | USL PHARMA, INC. | 4/17/02 |
| 11 | 65-065 | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS, USP (CHEWABLE 200 MG/28.5 MG (BASE), RESPECTIVELY; & 400 MG/57 MG (BASE), RESPECTIVELY. | GENEVA PHARMACEUTICALS, INC. | 4/18/02 |
| 12 | 40-420 | PHENYTOIN ORAL SUSPENSION, USP 125 MG/5 ML | MORTON GROVE PHARMACEUTICALS, INC. | 4/19/02 |
| 13 | 75-929 | BUTALBITAL, ACETAMINOPHEN, CAFFEINE & CODEINE PHOS. CAPSULES 50 MG/325 MG/40 MG/30 MG | VINTAGE PHARMACEUTICALS, INC. | 4/22/02 |
| 14 | 75-984 | METFORMIN HYDROCHLORIDE TABLETS 500 MG, 850 MG, AND 1000 MG | TORPHARM | 4/23/02 |
| 15 | 76-125 | FLUVOXAMINE MALEATE TABLETS 25 MG, 50 MG, AND 100 MG | MUTUAL PHARMACEUTICAL COMPANY, INC. | 4/29/02 |
| 16 | 75-333 | CROMOLYN SODIUM INHALATION SOLUTION, USP 10 MG/ML (20 MG/2 ML UNIT-DOSE AMPULE) | NOVEX PHARMA | 4/30/02 |
| 17 | 75-789 | FAMOTIDINE INJECTION (PRESERVATIVE-FREE) 10 MG/ML (2 ML VIALS) | BAXTER HEALTHCARE CORPORATION | 4/30/02 |
| 18 | 75-799 | FAMOTIDINE INJECTION 10 MG/ML (4 ML & 20 ML MULTIPLE-DOSE VIALS) | BAXTER HEALTHCARE CORPORATION | 4/30/02 |
| 19 | 75-873 | MIDAZOLAM HYDROCHLORIDE SYRUP 2 MG (BASE)/ML | ROXANE LABORATORIES, INC. | 4/30/02 |
FDA/Center for Drug Evaluation and Research
Last Updated: April 25, 2006
Originator: OGC
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