| |
ANDA Number |
Generic Drug Name |
Applicant |
Tentative Approval Date |
| 1 |
76-788 |
MOMETASONE FUROATE TOPICAL SOLUTION, USP (LOTION) 0.1% |
TARO PHARMACEUTICALS USA, INC. |
12/3/2004 |
| 2 |
76-679 |
MOMETASONE FUROATE CREAM, USP 0.1% |
TARO PHARMACEUTICALS USA, INC. |
12/3/2004 |
| 3 |
75-719 |
SERTRALINE HYDROCHLORIDE TABLETS 25 MG (BASE), 50 MG (BASE), AND 100 MG (BASE) |
IVAX PHARMACEUTICALS, INC. |
12/9/2004 |
| 4 |
76-605 |
GABAPENTIN TABLETS 600 MG AND 800 MG |
RANBAXYLABORATORIES LIMITED |
12/9/2004 |
| 5 |
76-610 |
OXYCODONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS 10 MG, 20 MG, AND 40 MG |
TEVA PHARMACEUTICALS USA |
12/9/2004 |
| 6 |
76-864 |
METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS 750 MG |
TEVA PHARMACEUTICALS USA |
12/13/2004 |
| 7 |
76-672 |
GABAPENTIN ORAL SOLUTION 250 MG/5 ML |
TARO PHARMACEUTICAL INDUSTRIES LTD. |
12/14/2004 |
| 8 |
76-327 |
TOPIRAMATE TABLETS 25 MG, 100 MG, AND 200 MG |
RANBAXY LABORATORIES LIMITED |
12/15/2004 |
| 9 |
76-747 |
ROSIGLITAZONE MALEATE TABLETS 2 MG (BASE), 4 MG (BASE), AND 8 MG (BASE) |
TEVA PHARMACEUTICALS USA |
12/20/2004 |
| 10 |
76-960 |
ONDANSETRON HYDROCHLORIDE ORAL SOLUTION 4 MG (BASE)/5 ML |
ROXANE LABORATORIES, INC. |
12/20/2004 |
| 11 |
76-719 |
AMLODIPINE BESYLATE TABLETS 2.5 MG (BASE), 5 MG (BASE), AND 10 MG (BASE) |
APOTEX INC. |
12/29/2004 |
