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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
28/03/2025 Inke S.A
Spain
INKE SA 36481 REVEFENACIN TRIHYDRATE 2022-07-27 Active II Complete 2022-09-01 2022-03-17
28/03/2025 Medichem S.A
Spain
MEDICHEM MANUFACTURING MALTA LTD 36861 REVEFENACIN 2022-04-19 Active II Complete 2022-05-10 2022-04-11