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Tentative Approvals - August 2004
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ANDA Number |
Generic Drug Name |
Applicant |
Tentative Approval Date |
1 |
77-011 |
ONDANSETRON INJECTION USP (PRESERVATIVE-FREE)
2 MG (BASE)/ML, PACKAGED IN 4 MG (BASE)/2 ML SINGLE-DOSE VIALS
|
BEDFORD LABORATORIES |
8/11/2004 |
2 |
76-967 |
ONDANSETRON INJECTION, USP 2 MG (BASE)/ML,
PACKAGED IN 40 MG (BASE)/20 ML MULTIPLE-DOSE VIALS |
BEDFORD LABORATORIES |
8/11/2004 |
3 |
76-671 |
SERTRALINE HYDROCHLORIDE TABLETS 25 MG
(BASE), 50 MG (BASE), AND 100 MG (BASE) |
MYLAN PHARMACEUTICALS INC. |
8/12/2004 |
4 |
76-677 |
CETIRIZINE HYDROCHLORIDE TABLETS 5 MG AND 10
MG |
MYLAN PHARMACEUTICALS, INC. |
8/20/2004 |
5 |
76-606 |
GABAPENTIN CAPSULES 100 MG, 300 MG, AND 400
MG |
RANBAXY LABORATORIES LIMITED |
8/25/2004 |
6 |
76-693 |
ONDANSETRON ORALLY DISINTEGRATING TABLETS 4
MG AND 8 MG |
BARR LABORATORIES, INC. |
8/26/2004 |
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Date created: September 8, 2004 |
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