| |
ANDA Number |
Generic Drug Name |
Applicant |
Tentative Approval Date |
| 1 |
76-314 |
TOPIRAMATE TABLETS 50 MG |
MYLAN PHARMACEUTICALS, INC. |
9/11/2006 |
| 2 |
77-535 |
ONDANSETRON HYDROCHLORIDE TABLETS 4 MG (BASE), 8 MG (BASE), AND 24 MG (BASE) |
GLENMARK PHARMACEUTICALS LIMITED |
9/12/2006 |
| 3 |
77-411 |
LAMIVUDINE AND ZIDOVUDINE TABLETS 150 MG/300 MG |
CIPLA LIMITED |
9/13/2006 |
| 4 |
77-900 |
RAMIPRIL CAPSULES 1.25 MG, 2.5 MG, 5 MG, AND 10 MG |
ROXANE LABORATORIES, INC. |
9/13/2006 |
| 5 |
77-884 |
ZOLPIDEM TARTRATE TABLETS 5 MG AND 10 MG |
APOTEX INC. |
9/15/2006 |
| 6 |
78-158 |
FOSPHENYTOIN SODIUM INJECTION USP, 75 MG/ML (50 MG PE/ML), PACKAGED IN 100 MG PE/2 ML AND 500 MG PE/10 ML SINGLE-DOSE VIALS (PE=PHENYTOIN SODIUM EQUIVALENTS) |
HOSPIRA INC. |
9/21/2006 |
| 7 |
76-882 |
SERTRALINE HYDROCHLORIDE TABLETS 125 MG (BASE), 50 MG (BASE), AND 100 MG (BASE) |
APOTEX INC. |
9/27/2006 |
| 8 |
77-687 |
CICLOPIROX TOPICAL SOLUTION 8% (NAIL LACQUER) |
QLT USA, INC. |
9/27/2006 |
| 9 |
77-643 |
TOPIRAMATE TABLETS 25 MG, 50 MG, 100 MG, AND 200 MG |
COBALT PHARMACEUTICALS INC. |
9/29/2006 |
| 10 |
77-993 |
OLANZAPINE TABLETS 5 MG |
ROXANE LABORATORIES, INC. |
9/29/2006 |
| 11 |
77-623 |
CICLOPIROX TOPICAL SOLUTION 8% (NAIL LACQUER) |
PERRIGO COMPANY |
9/29/2006 |
