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List of Drug Master Files (DMF) of Enalapril Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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Last Updated on PharmaCompass Virtual Booth Country Holder DMF No. Subject Submission Date Status Type GDUFA DMF Review GDUFA Review Date GDUFA Payment Date
26/09/2024 Medichem S.A
Spain
MEDICHEM SA 13055 ENALAPRIL MALEATE 1998-06-29 Active II N/A
26/09/2024 Neuland Laboratories
India
NEULAND LABORATORIES LTD 15434 ENALAPRIL MALEATE 2001-05-15 Active II N/A