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List of Drug Master Files (DMF) of Triamterene 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 Sanofi
France
ROUSSELL UCLAF 3787 TRIAMTERENE 1980-04-15 Inactive II N/A
26/09/2024 Moehs Iberica
Spain
MOEHS IBERICA SL 6603 TRIAMTERENE 1986-09-22 Active II Complete 2013-11-20 2013-10-29