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List of Drug Master Files (DMF) of Meglumine Antimonate 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
26/09/2024 Sanofi
France
SANOFI AVENTIS US INC 36014 MEGLUMINE ANTIMONIATE (GLUCANTIME) 2021-10-27 Active II N/A