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List of Drug Master Files (DMF) of CAS-58-46-8 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 ChemWerth Inc
U.S.A
CHEMWERTH INC 24946 TETRABENAZINE(NON-STERILE BULK DRUG SUBSTANCE) 2011-10-18 Active II N/A
26/09/2024 Inke S.A
Spain
INKE SA 37218 TETRABENAZINE 2022-06-21 Active II N/A