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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - January 2002

 ANDA NumberDrug NameApplicantTentative Approval Date
176-007LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS 10 MG/12.5 MG, 20 MG/12.5 MG, AND 20 MG/25 MGRANBAXY LABORATORIES LIMITED1/4/02
276-113LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS 10 MG/12.5 MG, 20 MG/12.5 MG, AND 20 MG/25 MGMYLAN PHARMACEUTICALS, INC.1/7/02
376-119MIRTAZAPINE TABLETS 15 MG, 30 MG, AND 45 MGTEVA PHARMACEUTICALS USA1/15/02
476-122MIRTAZAPINE TABLETS 15 MG, 30 MG, AND 45 MGMYLAN PHARMACEUTICALS, INC.1/15/02
575-250PREDNISOLONE SODIUM PHOSPHATE ORAL SOLUTION 15 MG (BASE)/5 MLWE PHARMACEUTICALS, INC.1/17/02
676-180LISINOPRIL TABLETS, USP 2.5 MG, 5 MG, AND 10 MGPUREPAC PHARMACEUTICAL CO.1/18/02
775-932BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS 100 MG, AND 150 MGEON LABS MANUFACTURING, INC.1/24/02