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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - January 2002

  ANDA Number Drug Name Applicant Tentative Approval Date
1 76-007 LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS 10 MG/12.5 MG, 20 MG/12.5 MG, AND 20 MG/25 MG RANBAXY LABORATORIES LIMITED 1/4/02
2 76-113 LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS 10 MG/12.5 MG, 20 MG/12.5 MG, AND 20 MG/25 MG MYLAN PHARMACEUTICALS, INC. 1/7/02
3 76-119 MIRTAZAPINE TABLETS 15 MG, 30 MG, AND 45 MG TEVA PHARMACEUTICALS USA 1/15/02
4 76-122 MIRTAZAPINE TABLETS 15 MG, 30 MG, AND 45 MG MYLAN PHARMACEUTICALS, INC. 1/15/02
5 75-250 PREDNISOLONE SODIUM PHOSPHATE ORAL SOLUTION 15 MG (BASE)/5 ML WE PHARMACEUTICALS, INC. 1/17/02
6 76-180 LISINOPRIL TABLETS, USP 2.5 MG, 5 MG, AND 10 MG PUREPAC PHARMACEUTICAL CO. 1/18/02
7 75-932 BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS 100 MG, AND 150 MG EON LABS MANUFACTURING, INC. 1/24/02

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