| |
ANDA Number |
Generic Drug Name |
Applicant |
Tentative Approval Date |
| 1 |
76-048 |
OMEPRAZOLE DELAYED-RELEASE CAPSULES 40 MG |
TORPHARM |
10/6/2003 |
| 2 |
75-827 |
GABAPENTIN TABLETS 600 MG AND 800 MG |
TEVA PHARMACEUTICALS USA |
10/16/2003 |
| 3 |
76-311 |
TOPIRAMATE TABLETS 25 MG, 100 MG, AND 200 MG |
PAR PHARMACEUTICAL, INC. |
10/22/2003 |
| 4 |
76-513 |
OFLOXACIN OPHTHALMIC SOLUTION, USP 0.3% |
NOVEX PHARMA |
10/22/2003 |
| 5 |
76-617 |
FLUCONAZOLE INJECTION IN 0.9% SODIUM CHLORIDE INJECTION 2 MG/ML;
PACKAGED IN 200 MG/100 ML AND 400 MG/200 ML SINGLE-DOSE PLASTIC CONTAINERS |
FAULDING PHARMACEUTICAL CO. |
10/30/2003 |
| 6 |
76-351 |
FLUCONAZOLE TABLETS 50 MG, 100 MG, 150 MG, AND 200 MG |
MYLAN PHARMACEUTICALS, INC. |
10/31/2003 |
| 7 |
76-413 |
METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS 500 MG |
RANBAXY LABORATORIES LIMITED |
10/31/2003 |
| 8 |
76-496 |
METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS 500 MG |
BARR LABORATORIES, INC. |
10/31/2003 |
