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Tentative Approvals -
October 2005
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ANDA Number |
Generic Drug Name |
Applicant |
Tentative Approval Date |
1 |
77-291 |
CYCLOBENZAPRINE HYDROCHLORIDE TABLETS USP, 5 MG |
AMIDE PHARMACEUTICAL, INC. |
10/4/2005 |
2 |
76-950 |
GATIFLOXACIN TABLETS 200 MG AND 400 MG |
TEVA PHARMACEUTICALS USA |
10/5/2005 |
3 |
76-714 |
PRAVASTATIN SODIUM TABLETS 10 MG, 20 MG, 40 MG, AND 80 MG |
DR. REDDY'S LABORATORIES, LIMITED |
10/5/2005 |
4 |
77-456 |
RIBAVIRIN TABLETS 200 MG, 400 MG, AND 600 MG |
THREE RIVERS PHARMACEUTICALS, LLC |
10/20/2005 |
5 |
77-300 |
ZOLPIDEM TARTRATE TABLETS 5 MG AND 10 MG |
PLIVA HRVATSKA D.O.O. |
10/28/2005 |
6 |
77-158 |
OLANZAPINE TABLETS 2.5 MG, 5 MG, 7.5 MG, 10 MG, 15 MG, AND 20 MG |
SANDOZ INC. |
10/31/2005 |
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Date created: November 3, 2005 |
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