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List of Drug Master Files (DMF) of Mls006010119 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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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
30/09/2024 Themis Medicare
India
THEMIS MEDICARE LIMITED DBA ARTEMIS BIOTECH 39867 SIMVASTATIN AMMONIUM SALT 2024-04-18 Active II N/A