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Tentative Approvals -
May 2005
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ANDA Number |
Generic Drug Name |
Applicant |
Tentative Approval Date |
| 1 |
76-710 |
LEVOFLOXACIN TABLETS, 250 MG, 500 MG, AND 750 MG |
DR. REDDY'S LABORATORIES LIMITED |
5/4/2005 |
| 2 |
76-616 |
OFLOXACIN OTIC SOLUTION, 0.3% |
HI-TECH PHARMACAL CO., INC. |
5/10/2005 |
| 3 |
77-111 |
BETAMETHASONE DIPROPRIONATE LOTION USP (AUGMENTED), 0.05% |
ALTANA, INC. |
5/11/2005 |
| 4 |
76-890 |
LEVOFLOXACIN TABLETS, 250 MG, 500 MG, AND 750 MG |
IVAX PHARMACEUTICALS, INC. |
5/19/2005 |
| 5 |
76-410 |
ZOLPIDEM TARTRATE TABLETS, 5 MG AND 10 MG |
TEVA PHARMACEUTICALS USA |
5/26/2005 |
| 6 |
77-357 |
LAMIVUDINE TABLETS, 150 MG |
RANBAXY LABORATORIES LIMITED |
5/27/2005 |
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Date created:
June 15, 2005  |
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