| |
ANDA Number |
Generic Drug Name |
Applicant |
Tentative Approval Date |
| 1 |
77-268 |
ZIDOVUDINE ORAL SOLUTION, USP 50 MG/5 ML |
AUROBINDO PHARMA LIMITED |
9/7/2005 |
| 2 |
77-351 |
FAMOTIDINE TABLETS USP, 20 MG (OTC) |
PERRIGO R&D COMPANY |
9/9/2005 |
| 3 |
77-100 |
DIVALPROEX SODIUM DELAYED-RELEASE TABLETS USP, 125 MG, 250 MG, AND 500 MG |
ZYDUS PHARMACEUTICALS USA, INC. |
9/9/2005 |
| 4 |
77-143 |
DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS, 250 MG |
RANBAXY LABORATORIES LIMITED |
9/12/2005 |
| 5 |
77-261 |
GABAPENTIN CAPSULES, 100 MG, 300 MG, AND 400 MG |
TARO PHARMACEUTICALS USA, INC. |
9/13/2005 |
| 6 |
77-018 |
METRONIDAZOLE TOPICAL GEL USP, 0.75% |
ALTANA INC. |
9/13/2005 |
| 7 |
76-953 |
TOLTERODINE TARTRATE TABLETS, 1 MG AND 2 MG |
RANBAXY LABORATORIES LIMITED |
9/15/2005 |
| 8 |
77-053 |
RIBAVIRIN TABLETS, 200 MG |
TEVA PHARMACEUTICALS USA |
9/15/2005 |
| 9 |
77-206 |
SERTRALINE HYDROCHLORIDE TABLETS, 25 MG (BASE), 50 MG (BASE), AND 100 MG (BASE) |
AUROBINDO PHARMA LIMITED |
9/16/2005 |
| 10 |
77-138 |
CIPROFLOXACIN AND DEXTROSE (5%) INJECTION USP, 2 MG/ML; 100 ML AND 200 ML PLASTIC CONTAINERS |
SICOR PHARMACEUTICALS, INC. |
9/21/2005 |
| 11 |
77-274 |
GLIMEPIRIDE TABLETS, 1 MG, 2 MG, AND 4 MG |
COREPHARMA, LLC |
9/21/2005 |
| 12 |
77-094 |
RIBAVIRIN TABLETS, 200 MG |
ZYDUS PHARMACEUTICALS USA, INC. |
9/30/2005 |
