| |
ANDA Number |
Generic Drug Name |
Applicant |
Tentative Approval Date |
| 1 |
76-309 |
NEFAZODONE HYDROCHLORIDE TABLETS 50 MG, 100 MG, 150 MG, 200 MG, AND 250 MG |
DR. REDDY'S LABORATORIES LIMITED |
7/7/2003 |
| 2 |
76-188 |
FOSINOPRIL SODIUM TABLETS 10 MG, 20 MG, AND 40 MG |
GENEVA PHARMACEUTICALS TECHNOLOGY CORP. |
7/10/2003 |
| 3 |
76-139 |
FOSINOPRIL SODIUM TABLETS 10 MG, 20 MG, AND 40 MG |
TEVA PHARMACEUTICALS USA |
7/10/2003 |
| 4 |
76-332 |
FLUCONAZOLE FOR ORAL SUSPENSION 10 MG/ML AND 40 MG/ML |
RANBAXY LABORATORIES LIMITED |
7/11/2003 |
| 5 |
76-578 |
ZOLPIDEM TARTRATE TABLETS 5 MG AND 10 MG |
MYLAN PHARMACEUTICALS, INC. |
7/17/2003 |
| 6 |
76-087 |
FLUCONAZOLE INJECTION (IN 0.9% SODIUM CHLORIDE INJECTION) 2 MG/ML PACKAGED IN
200 MG /100ML 400 MG/200 ML FLEXIBLE PLASTIC CONTAINERS |
BEDFORD LABORATORIES |
7/17/2003 |
| 7 |
76-199 |
PRAVASTATIN SODIUM TABLETS 10 MG, 20 MG, AND 40 MG |
IVAX PHARMACEUTICALS, INC. |
7/31/2003 |
