| |
ANDA Number |
Generic Drug Name |
Applicant |
Tentative Approval Date |
| 1 |
76-878 |
METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS 750 MG |
PUREPAC PHARMACEUTICAL COMPANY |
10/4/2004 |
| 2 |
76-221 |
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS, USP 1 MG/0.005 MG |
BARR LABORATORIES, INC. |
10/5/2004 |
| 3 |
76-912 |
CIPROFLOXACIN TABLETS, USP 100 MG |
TARO PHARMACEUTICAL INDUSTRIES LTD. |
10/6/2004 |
| 4 |
76-047 |
CETIRIZINE HYDROCHLORIDE TABLETS 5 MG AND 10 MG |
PAR PHARMACEUTICAL, INC. |
10/6/2004 |
| 5 |
76-873 |
METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS 500 MG |
EON LABS MANUFACTURING, INC. |
10/13/2004 |
| 6 |
76-436 |
FINASTERIDE TABLETS, USP 1 MG |
DR. REDDY'S LABORATORIES LIMITED |
10/14/2004 |
| 7 |
75-485 |
GABAPENTIN CAPSULES 100 MG, 300 MG, AND 400 MG |
WATSON LABORATORIES, INC. |
10/18/2004 |
| 8 |
76-989 |
CARVEDILOL TABLETS 3.125 MG, 6.25 MG, 12.5 MG, AND 25 MG |
RANBAXY LABORATORIES LIMITED |
10/22/2004 |
| 9 |
76-511 |
FINASTERIDE TABLETS, USP 5 MG |
TEVA PHARMACEUTICALS USA |
10/26/2004 |
| 10 |
76-744 |
TESTOSTERONE GEL 1% |
PADDOCK LABORATORIES, INC. |
10/27/2004 |
