Drug Information |
ANDA Number | Generic Drug Name | Applicant | Approval Date | |
---|---|---|---|---|
1 | 76-028 | VINORELBINE TARTRATE INJECTION 10 MG (BASE)/ML; PACKAGED IN 10 MG/ML AND 50 MG/5 ML SINGLE-DOSE VIALS | GENSIA SICOR PHARMACEUTICALS, INC. | 2/3/03 |
2 | 75-822 | LORATADINE ORALLY DISINTEGRATING TABLETS (OTC) 10 MG | WYETH CONSUMER HEALTHCARE | 2/10/03 |
3 | 40-392 | PREDNISONE TABLETS, USP 20 MG | VINTAGE PHARMACEUTICALS, INC. | 2/12/03 |
4 | 40-433 | LIDOCAINE HYDROCHLORIDE JELLY, USP 2% (5 ML & 30 ML TUBES) | AKORN INC. | 2/12/03 |
5 | 70-929 | TAMOXIFEN CITRATE TABLETS, USP 10 MG (BASE) 20 MG (BASE) | BARR LABORATORIES, INC. | 2/20/03 |
6 | 74-732 | TAMOXIFEN CITRATE TABLETS, USP 10 MG (BASE) 20 MG (BASE) | MYLAN PHARMACEUTICALS, INC. | 2/20/03 |
7 | 74-858 | TAMOXIFEN CITRATE TABLETS, USP 20 MG (BASE) | PHARMACHEMIE B.V. | 2/20/03 |
8 | 75-740 | TAMOXIFEN CITRATE TABLETS, USP 10 MG (BASE) 20 MG (BASE) | IVAX PHARMACEUTICALS, INC. | 2/20/03 |
9 | 75-766 | CALCITRIOL INJECTION 0.001 MG/ML AND 0.002 MG/ML PACKAGED IN 1 ML SINGLE-DOSE VIALS | aaiPHARMA, INC. | 2/20/03 |
10 | 75-797 | TAMOXIFEN CITRATE TABLETS, USP 10 MG (BASE) | TEVA PHARMACEUTICALS USA | 2/20/03 |
11 | 76-027 | TAMOXIFEN CITRATE TABLETS, USP 10 MG (BASE) AND 20 MG (BASE) | ROXANE LABORATORIES, INC. | 2/20/03 |
12 | 76-179 | TAMOXIFEN CITRATE TABLETS, USP 10 MG (BASE) AND 20 MG (BASE) | ANDRX PHARMACEUTICALS, L.L.C. | 2/20/03 |
13 | 75-706 | LORATADINE & PSEUDOEPHEDRINE SULFATE EXTENDED-RELEASE TABLET 10 MG/240 MG (24-HOUR FORMULATION) (OTC) | ANDRX PHARMACEUTICALS, L.L.C. | 2/21/03 |
14 | 40-447 | ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 500 MG/15 MG | ANDRX PHARMACEUTICALS, L.L.C. | 2/26/03 |
15 | 76-400 | PROPRANOLOL HYDROCHLORIDE INJECTION, USP 1 MG/ML | SABEX, INC. | 2/26/03 |
16 | 40-401 | PREDNISOLONE SYRUP, USP 15 MG/5 ML | HI-TECH PHARMACAL CO., INC. | 2/27/03 |
17 | 40-449 | PROMETHAZINE HYDROCHLORIDE SUPPOSITORIES, USP 50 MG | ABLE LABORATORIES, INC. | 2/27/03 |
18 | 75-438 | MINOXIDIL TOPICAL SOLUTION, USP (FOR MEN) 5% (OTC) | MORTON GROVE PHARMACEUTICALS, INC. | 2/27/03 |
FDA/Center for Drug Evaluation and Research
Last Updated: March 7, 2003
Originator: OTCOM/OGD
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