|
| ANDA Number
| Generic Drug Name
| APPLICANT
| Tentative Approval Date
|
| 1 |
76-138 |
CIPROFLOXACIN TABLETS, USP 250 MG, 500 MG, AND 750 MG |
TECHNILAB PHARMA, INC. |
9/11/02 |
| 2 |
76-028 |
VINORELBINE TARTRATE INJECTION 10 MG (BASE)/ML PACKAGED IN 10 MG/1 ML AND 50
MG/5 ML SINGLE-DOSE VIALS |
GENSIA SICOR PHARMACEUTICALS, INC. |
9/17/02 |
| 3 |
76-308 |
MIRTAZAPINE TABLETS 15 MG, 30 MG, AND 45 MG |
PUREPAC PHARMACEUTICAL CO. |
9/17/02 |
| 4 |
76-099 |
CARBOPLATIN FOR INJECTION, USP 50 MG, 150 MG, AND 450 MG SINGLE-DOSE VIALS |
BEDFORD LABORATORIES |
9/18/02 |
