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List of Drug Master Files (DMF) of Dronedarone Hydrochloride 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 ChemWerth Inc
U.S.A
CHEMWERTH INC 26479 DRONEDARONE HYDROCHLORIDE NON-STERILE BULK DRUG 2013-05-02 Active II Complete 2013-11-01 2013-05-07
26/09/2024 Sanofi
France
SANOFI WINTHROP INDUSTRIE 18409 DRONEDARONE HYDROCHLORIDE 2005-06-08 Active II N/A