Tentative Approvals - November 2005
|
ANDA Number |
Generic Drug Name |
Applicant |
Tentative Approval Date |
1 |
77-695 |
LAMIVUDINE ORAL SOLUTION, 10 MG/ML |
AUROBINDO PHARMA LIMITED |
11/4/2005 |
2 |
77-237 |
ZALEPLON CAPSULES, 5 MG AND 10 MG |
ROXANE LABORATORIES, INC. |
11/4/2005 |
3 |
77-284 |
BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS USP, 150 MG AND 300 MG |
ANCHEN PHARMACEUTICALS, INC. |
11/14/2005 |
4 |
76-948 |
GATIFLOXACIN TABLETS, 200 MG AND 400 MG |
ZYDUS PHARMACEUTICALS USA, INC. |
11/25/2005 |
5 |
77-239 |
ZALEPON CAPSULES, 5 MG AND 10 MG |
TEVA PHARMACEUTICALS USA |
11/25/2005 |
6 |
76-310 |
CABERGOLINE TABLETS, 0.5 MG |
PAR PHARMACEUTICAL INC. |
11/30/2005 |
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Date created: December 20, 2005 |
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