Tentative Approvals - February 2003
|
ANDA Number |
Generic Drug Name |
Applicant |
Tentative Approval Date |
1 |
76-213 |
FLUCONAZOLE TABLETS 50 MG, 100 MG, 150 MG, AND 200 MG |
ROXANE LABORATORIES, INC. |
2/11/03 |
2 |
76-241 |
MIRTAZAPINE TABLETS 15 MG, 30 MG, AND 45 MG |
AMIDE PHARMACEUTICAL, INC. |
2/12/03 |
3 |
76-208 |
LORATADINE & PSEUDOPEHEDRINE SULFATE EXTENDED-RELEASE TABLET 5 MG/120 MG
(12-HOUR FORMULATION) (OTC) |
ANDRX PHARMACEUTICALS L.L.C. |
2/24/03 |
4 |
76-267 |
BENAZEPRIL HYDROCHLORIDE TABLETS 5 MG, 10 MG, 20 MG, AND 40 MG |
ANDRX PHARMACEUTICALS L.L.C. |
2/26/03 |
5 |
76-344 |
BENAZEPRIL HYDROCHLORIDE TABLETS 5 MG, 10 MG, 20 MG, AND 40 MG |
RANBAXY LABORATORIES LIMITED |
2/26/03 |
6 |
76-402 |
BENAZEPRIL HYDROCHLORIDE TABLETS 5 MG, 10 MG, 20 MG, AND 40 MG |
EON LABS, INC. |
2/26/03 |
7 |
76-300 |
FLUTICASONE PROPIONATE OINTMENT 0.005% |
ALTANA INC. |
2/27/03 |
8 |
75-276 |
BETAMETHASONE DIPROPIONATE GEL (AUGMENTED) 0.05% (BASE) |
ALTANA INC. |
2/28/03 |
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FDA/Center for Drug Evaluation and Research
Last Updated: March 7, 2003
Originator: OTCOM/DLIS
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