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List of Drug Master Files (DMF) of Dextroamphetamine Saccharate 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 Veranova
U.S.A
VERANOVA LP 15090 DEXTROAMPHETAMINE SACCHARATE 2000-10-13 Active II N/A
26/09/2024 Veranova
U.S.A
VERANOVA LP 24071 DEXTROAMPHETAMINE SACCHARATE (PROCESS 2) 2010-08-10 Active II Complete 2013-04-10 2013-04-03