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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 Cohance Lifesciences
India
COHANCE LIFESCIENCES LTD 21251 METAXALONE USP 2008-01-15 Active II Complete 2016-04-06 2015-09-22
28/03/2025 Angelini Pharma
Italy
ANGELINI ACRAF SPA 15100 METAXALONE 2000-10-19 Active II Complete 2013-02-26 2013-02-11