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List of Drug Master Files (DMF) of duraspiron 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 EUROAPI
France
EUROAPI FRANCE 17264 SPIRONOLACTONE 2004-03-26 Active II Complete 2013-02-06 2013-01-23
26/09/2024 Nortec Quimica
Brazil
NORTEC QUIMICA SA 37708 SPIRONOLACTONE 2024-06-06 Active II N/A