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Tentative Approvals - May 2004
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ANDA Number |
Generic Drug Name |
Applicant |
Tentative Approval Date |
| 1 |
76-614 |
LEVOFLOXACIN INJECTION IN DEXTROSE 5% (PREMIX) 5 MG/ML; PACKAGED IN 250 MG
(BASE)/50 ML, 500 MG (BASE)/100 ML, & 750 MG (BASE)/150 ML SINGLE-USE VIALS |
BEDFORD LABORATORIES |
5/14/2004 |
| 2 |
76-599 |
LEVOFLOXACIN INJECTION 25 MG/ML; PACKAGED IN
500 MG (BASE)/20 ML & 750 MG (BASE)/30 ML SINGLE-USE VIALS |
BEDFORD LABORATORIES |
5/14/2004 |
| 3 |
76-713 |
TERBINAFINE HYDROCHLORIDE TABLETS 250 MG (BASE) |
ANDRX PHARMACEUTICALS, LLC |
5/19/2004 |
| 4 |
76-658 |
FLUCONAZOLE TABLETS 50 MG, 100 MG, 150 MG, AND 200 MG |
DR. REDDY'S LABORATORIES LIMITED |
5/20/2004 |
| 5 |
76-768 |
ALENDRONATE SODIUM TABLETS 5 MG (BASE), 10 MG
(BASE), 35 MG (BASE), 40 MG (BASE) AND 70 MG (BASE) |
WATSON LABORATORIES, INC. |
5/25/2004 |
| 6 |
76-694 |
QUINAPRIL HYDROCHLORIDE TABLETS 5 MG (BASE), 10 MG (BASE), 20 MG (BASE),
AND 40 MG (BASE) |
MYLAN PHARMACEUTICALS, INC. |
5/26/2004 |
| 7 |
76-635 |
FENOFIBRATE TABLETS 54 MG, 107 MG, AND 160 MG |
RANBAXY LABORATORIES LIMITED |
5/27/2004 |
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Date created: June 16, 2004  |
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