|
| 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 |
