| |
ANDA Number |
Generic Drug Name |
Applicant |
Tentative Approval Date |
| 1 |
77-214 |
ZOLPIDEM TARTRATE TABLETS 5 MG AND 10 MG |
ROXANE LABORATORIES, INC. |
6/6/2005 |
| 2 |
77-464 |
LAMIVUDINE TABLETS 150 MG AND 300 MG |
AUROBINDO PHARMA LIMITED |
6/15/2005 |
| 3 |
77-444 |
TERBINAFINE HYDROCHLORIDE TABLETS 250 MG (BASE) |
RANBAXY LABORATORIES, LTD. |
6/16/2005 |
| 4 |
76-506 |
ONDANSETRON ORALLY DISINTEGRATING TABLETS 4 MG, AND 8 MG |
KALI LABORATORIES, INC. |
6/17/2005 |
| 5 |
77-304 |
CAFFEINE CITRATE ORAL SOLUTION 10 MG (BASE)/ML |
PHARMAFORCE, INC. |
6/20/2005 |
| 6 |
77-233 |
CAFFEINE CITRATE INJECTION 20 MG (BASE)/ML |
PHARMAFORCE, INC. |
6/20/2005 |
| 7 |
77-521 |
NEVIRAPINE TABLETS 200 MG |
AUROBINDO PHARMA LIMITED |
6/20/2005 |
| 8 |
77-429 |
NEVIRAPINE TABLETS 200 MG |
RANBAXY LABORATORIES LIMITED |
6/20/2005 |
| 9 |
77-073 |
AMLODIPINE BESYLATE TABLETS 2.5 MG (BASE), 5 MG (BASE), AND 10 MG (BASE) |
WATSON LABORATORIES, INC. |
6/22/2005 |
| 10 |
77-673 |
EFAVIRENZ TABLETS 600 MG |
AUROBINDO PHARMA LIMITED |
6/24/2005 |
| 11 |
76-802 |
GLIMEPIRIDE TABLETS 1 MG, 2 MG, AND 4 MG |
TEVA PHARMACEUTICALS USA |
6/27/2005 |
| 12 |
77-013 |
PRAVASTATIN SODIUM TABLETS 10 MG, 20 MG, 40 MG, AND 80 MG |
GENPHARM INC. |
6/27/2005 |
| 13 |
77-223 |
TERBINAFINE HYDROCHLORIDE TABLETS 250 MG (BASE) |
ROXANE LABORATORIES, INC. |
6/27/2005 |
