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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - February 2003

 ANDA NumberGeneric Drug NameApplicantTentative Approval Date
176-213FLUCONAZOLE TABLETS 50 MG, 100 MG, 150 MG, AND 200 MGROXANE LABORATORIES, INC.2/11/03
276-241MIRTAZAPINE TABLETS 15 MG, 30 MG, AND 45 MGAMIDE PHARMACEUTICAL, INC.2/12/03
376-208LORATADINE & PSEUDOPEHEDRINE SULFATE EXTENDED-RELEASE TABLET 5 MG/120 MG (12-HOUR FORMULATION) (OTC)ANDRX PHARMACEUTICALS L.L.C.2/24/03
476-267BENAZEPRIL HYDROCHLORIDE TABLETS 5 MG, 10 MG, 20 MG, AND 40 MGANDRX PHARMACEUTICALS L.L.C.2/26/03
576-344BENAZEPRIL HYDROCHLORIDE TABLETS 5 MG, 10 MG, 20 MG, AND 40 MGRANBAXY LABORATORIES LIMITED2/26/03
676-402BENAZEPRIL HYDROCHLORIDE TABLETS 5 MG, 10 MG, 20 MG, AND 40 MGEON LABS, INC.2/26/03
776-300FLUTICASONE PROPIONATE OINTMENT 0.005%ALTANA INC.2/27/03
875-276BETAMETHASONE DIPROPIONATE GEL (AUGMENTED) 0.05% (BASE)ALTANA INC.2/28/03