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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 36436 CLEVIDIPINE BUTYRATE 2022-06-14 Active II Complete 2022-09-02 2022-03-17
28/03/2025 ChemWerth Inc
U.S.A
CHEMWERTH INC 34556 CLEVIDIPINE 2020-06-01 Active II Complete 2020-08-04 2020-06-23