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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - April 2001

 ANDA NumberDrug NameApplicantTentative Approval Date
175-588IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLETS, USP 200 MG/30 MGPHARMACEUTICAL FORMULATIONS, INC.4/17/01
275-788ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLETS, USP 5 MG/12.5 MG; AND 10 MG/25 MGTARO PHARMACEUTICAL INDUSTRIES, LTD.4/18/01
375-869LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS 10 MG/12.5 MG; 20 MG/12.5 MG; AND 20 MG/25 MGTEVA PHARMACEUTICALS USA4/18/01