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List of Drug Master Files (DMF) of AM20060525 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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$ API Ref.Price (USD/KG) : 149Xls 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 Cohance Lifesciences
India
COHANCE LIFESCIENCES LTD 21251 METAXALONE USP 2008-01-15 Active II Complete 2016-04-06 2015-09-22
26/09/2024 Angelini Pharma
Italy
ANGELINI ACRAF SPA 15100 METAXALONE 2000-10-19 Active II Complete 2013-02-26 2013-02-11