|
ANDA Number |
Generic Drug Name |
Applicant |
Tentative Approval Date |
1 |
76-317 |
TOPIRAMATE TABLETS 50 MG |
TEVA PHARMACEUTICALS USA |
3/3/2006 |
2 |
77-447 |
MOMETASONE FUROATE CREAM USP, 0.1% |
G & W LABORATORIES, INC. |
3/7/2006 |
3 |
77-678 |
MOMETASONE FUROATE TOPICAL SOLUTION USP, 0.1% |
G & W LABORATORIES, INC. |
3/7/2006 |
4 |
76-974 |
ONDANSETRON INJECTION USP, 2 MG/ML; PACKAGED IN 40 MG/20 ML MULTIPLE-DOSE VIALS |
AMERICAN PHARMACEUTICAL PARTNERS, INC. |
3/7/2006 |
5 |
76-972 |
ONDANSETRON INJECTION USP, (PRESERVATIVE-FREE) 2 MG/ML; PACKAGED IN 4 MG/2 ML SINGLE-DOSE VIALS |
AMERICAN PHARMACEUTICAL PARTNERS, INC. |
3/7/2006 |
6 |
77-614 |
CARVEDILOL TABLETS 3.125 MG, 6.25 MG, 12.5 MG, AND 25 MG |
ZYDUS PHARMACEUTICALS USA, INC. |
3/10/2006 |
7 |
77-200 |
KETOTIFEN FUMARATE OPHTHALMIC SOLUTION 0.025% |
ALCON RESEARCH, LTD. |
3/17/2006 |
8 |
77-511 |
TERBINAFINE HYDROCHLORIDE CREAM 1% |
TARO PHARMACEUTICALS USA INC. |
3/22/2006 |
9 |
76-954 |
GATIFLOXACIN TABLETS 200 MG AND 400 MG |
DR. REDDY'S LABORATORIES LIMITED |
3/27/2006 |
10 |
77-137 |
TERBINAFINE HYDROCHLORIDE TABLETS, 250 MG (BASE) |
WATSON LABORATORIES, INC. |
3/28/2006 |
11 |
77-131 |
RIVASTIGMINE TARTRATE CAPSULES, 1.5 MG (BASE), 3 MG (BASE), 4.5 MG (BASE), AND 6 MG (BASE) |
SUN PHARMACEUTICAL INDUSTRIES LTD. |
3/29/2006 |