| |
ANDA Number |
Generic Drug Name |
Applicant |
Tentative Approval Date |
| 1 |
76-042 |
FLUCONAZOLE TABLETS 50 MG, 100 MG, 150 MG, AND 200 MG |
GENPHARM INC. |
4/10/2003 |
| 2 |
76-145 |
FLUCONAZOLE INJECTION (IN 0.9% SODIUM CHLORIDE INJECTION) 200 MG/100 ML
AND 400 MG/200 ML SINGLE-DOSE VIALS. |
AMERICAN PHARMACEUTICAL PARTNERS, INC. |
4/15/2003 |
| 3 |
76-473 |
CARBOPLATIN FOR INJECTION, USP 50 MG, 150 MG, AND 450 MG PACKAGED IN SINGLE- DOSE VIALS |
FAULDING PHARMACEUTICAL COMPANY |
4/16/2003 |
| 4 |
76-409 |
NEFAZODONE HYDROCHLORIDE TABLETS 50 MG, 100 MG, 150 MG, 200 MG, AND 250 MG |
RANBAXY LABORATORIES LIMITED |
4/17/2003 |
| 5 |
76-404 |
ADENOSINE INJECTION, USP 3 MG/ML PACKAGED IN 6 MG/2 ML AND 12 MG/4 ML SINGLE-DOSE VIALS |
BEDFORD LABORATORIES |
4/18/2003 |
| 6 |
76-246 |
FLUCONAZOLE FOR ORAL SUSPENSION 10 MG/ML AND 40 MG/ML |
ROXANE LABORATORIES, INC. |
4/18/2003 |
| 7 |
76-314 |
TOPIRAMATE TABLETS 25 MG, 100 MG, AND 200 MG |
MYLAN PHARMACEUTICALS, INC. |
4/23/2003 |
| 8 |
76-094 |
PERGOLIDE MESYLATE TABLETS, USP 0.05 MG (BASE), 0.25 MG (BASE), AND 1 MG (BASE) |
IVAX PHARMACEUTICALS s.r.o. |
4/24/2003 |
