| |
ANDA Number |
Generic Drug Name |
Applicant |
Tentative Approval Date |
| 1 |
76-615 |
OFLOXACIN OPHTHALMIC SOLUTION, USP 0.3% |
HI-TECH PHARMACAL CO., INC. |
4/19/2004 |
| 2 |
76-589 |
FLUMAZENIL INJECTION 0.1 MG/ML |
SICOR PHARMACEUTICALS, INC. |
4/21/2004 |
| 3 |
76-633 |
FLUTICASONE PROPIONATE CREAM 0.05% |
ATRIX LABORATORIES, INC. |
4/26/2004 |
| 4 |
76-361 |
LEVOFLOXACIN TABLETS 250 MG, 500 MG, AND 750 MG |
TEVA PHARMACEUTICALS USA |
4/26/2004 |
| 5 |
76-017 |
GABAPENTIN TABLETS 600 MG AND 800 MG |
IVAX PHARMACEUTICALS, INC. |
4/28/2004 |
| 6 |
76-538 |
FEXOFENADINE HCL & PSEUDOEPHEDRINE HCL EXTENDED-RELEASE TABL 60 MG/120 MG |
MYLAN PHARMACEUTICALS, INC. |
4/30/2004 |
| 7 |
76-766 |
FLUCONAZOLE INJECTION (IN 0.9% SODIUM CHLORIDE INJECTION) 2 MG/ML; PACKAGED
IN 200 MG/100 ML & 400 MG/200 ML INTRAVIA PLASTIC CONTAINERS |
BAXTER HEALTHCARE CORPORATION |
4/30/2004 |
