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

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$ API Ref.Price (USD/KG) : 442,770Xls download

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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 Inke S.A
Spain
INKE SA 36481 REVEFENACIN TRIHYDRATE 2022-07-27 Active II Complete 2022-09-01 2022-03-17
26/09/2024 Medichem S.A
Spain
MEDICHEM MANUFACTURING MALTA LTD 36861 REVEFENACIN 2022-04-19 Active II Complete 2022-05-10 2022-04-11