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U.S. Department of Health and Human Services

Drugs

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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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