U.S. Food and Drug Administration • Center for Drug Evaluation
and Research |
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Drug Information |
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Approvals - January 2003
| ANDA Number | Generic Drug Name | Applicant | Approval Date | |
|---|---|---|---|---|
| 1 | 40-474 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP 7.5 MG/650 MG | ABLE LABORATORIES, INC. | 1/2/03 |
| 2 | 75-941 | STRONTIUM CHLORIDE Sr-89 INJECTION, USP 1 mCi/Ml | BIO-NUCLEONICS PHARMA, INC. | 1/6/03 |
| 3 | 76-266 | DOXAPRAM HYDROCHLORIDE INJECTION, USP 20 MG/ML (400 MG/20 ML) MULTIPLE- DOSE VIAL | BEDFORD LABORATORIES | 1/10/03 |
| 4 | 40-460 | PHENTERMINE HYDROCHLORIDE CAPSULES, USP 15 MG | AMIDE PHARMACEUTICAL, INC. | 1/14/03 |
| 5 | 76-278 | FLECAINIDE ACETATE TABLETS, USP 50 MG, 100 MG, AND 150 MG | ROXANE LABORATORIES, INC. | 1/14/03 |
| 6 | 76-375 | RIMANTADINE HYDROCHLORIDE TABLETS 100 MG | AMIDE PHARMACEUTICAL, INC. | 1/14/03 |
| 7 | 40-425 | FLUDROCORTISONE ACETATE TABLETS, USP 0.1 MG | BARR LABORATORIES, INC. | 1/21/03 |
| 8 | 75-209 | LORATADINE TABLETS (OTC) 10 MG | GENEVA PHARMACEUTICALS, INC. | 1/21/03 |
| 9 | 40-432 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP 7.5 MG/325 MG | MIKART, INC. | 1/22/03 |
| 10 | 40-443 | ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 300 MG/15 MG, 300 MG/30 MG; AND 300 MG/60 MG | ANDRX PHARMACEUTICALS, INC. | 1/22/03 |
| 11 | 40-448 | PHENTERMINE HYDROCHLORIDE CAPSULES, USP 30 MG | AMIDE PHARMACEUTICAL, INC. | 1/22/03 |
| 12 | 76-383 | NIZATIDINE CAPSULES, USP 150 MG, AND 300 MG | TORPHARM | 1/23/03 |
| 13 | 75-800 | ETIDRONATE DISODIUM TABLETS, USP 200 MG AND 400 MG | GENPHARM INC. | 1/24/03 |
| 14 | 76-009 | NABUMETONE TABLETS 500 MG AND 750 MG | IVAX PHARMACEUTICALS, INC. | 1/24/03 |
| 15 | 76-119 | MIRTAZAPINE TABLETS 15 MG AND 30 MG | TEVA PHARMACEUTICALS USA | 1/24/03 |
| 16 | 75-757 | OMEPRAZOLE DELAYED-RELEASE CAPSULES 10 MG AND 20 MG | LEK PHARMACEUTICALS d.d. | 1/28/03 |
| 17 | 40-489 | METHOCARBAMOL TABLETS, USP 500 MG AND 750 MG | VINTAGE PHARMACEUTICALS, INC. | 1/29/03 |
| 18 | 76-173 | RILUZOLE TABLETS 50 MG | IMPAX LABORATORIES, INC. | 1/29/03 |
| 19 | 76-050 | LORATADINE AND PSEUDOEPHEDRINE SULFATE EXTENDED-RELEASE TABL 5 MG/120 MG (12-HOUR FORMULATION) (OTC) | IMPAX LABORATORIES | 1/30/03 |
| 20 | 40-387 | BUTALBITAL, ACETAMINOPHEN, & CAFFEINE ORAL SOLUTION 50 MG/325 MG/40 MG, RESPECTIVELY, PER 15 ML | MIKART, INC. | 1/31/03 |
| 21 | 76-363 | DIGOXIN TABLETS, USP 0.125 MG AND 0.25 MG | CARACO PHARMACEUTICAL LABORATORIES, LTD. | 1/31/03 |
FDA/Center for Drug Evaluation and Research
Last Updated: January 2, 2003
Originator: OTCOM/OGD
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