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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 Indena
Italy
INDENA SPA 28747 INGENOL MEBUTATE 2014-12-22 Inactive II N/A
28/03/2025 Sichuan Xieli Pharmaceutical
China
SICHUAN XIELI PHARMACEUTICAL CO LTD 29556 INGENOL MEBUTATE 2015-07-17 Active II Complete 2015-12-23 2015-08-12