Tentative Approvals - November 2004
| |
ANDA Number |
Generic Drug Name |
Applicant |
Tentative Approval Date |
| 1 |
76-801 |
PIOGLITAZONE HYDROCHLORIDE TABLETS 15 MG, 30 MG, AND 45 MG |
MYLAN PHARMACEUTICALS INC. |
11/3/2004 |
| 2 |
76-317 |
TOPIRAMATE TABLETS 25 MG, 100 MG, AND 200 MG |
TEVA PHARMACEUTICALS USA |
11/4/2004 |
| 3 |
76-886 |
FOSPHENYTOIN SODIUM INJECTION, USP 50 PE/ML [PE = PHENYTOIN SODIUM EQUIVALENTS]
PACKAGED IN 100 PE/2 ML AND 500 MG PE/10 ML SINGLE-DOSE VIALS. |
SICOR PHARMACEUTICALS, INC. |
11/18/2004 |
| 4 |
76-649 |
CARVEDILOL TABLETS 3.125 MG, 6.25 MG, 12.5 MG, AND 25 MG |
DR, REDDY'S LABORATORIES LIMITED |
11/24/2004 |
| 5 |
76-703 |
DESMOPRESSIN ACETATE NASAL SOLUTION 0.01% (NASAL SPRAY) |
APOTEX INC. |
11/30/2004 |
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Date created:
December 17, 2004  |
|
