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List of Drug Master Files (DMF) of Tox21_300395 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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$ API Ref.Price (USD/KG) : 145Xls 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 PMC Isochem
France
PMC ISOCHEM 7617 AMIODARONE HYDROCHLORIDE 1988-08-02 Active II Complete 2013-02-26 2013-02-13
26/09/2024 Taro Pharmaceutical Industries
U.S.A
TARO PHARMACEUTICAL INDUSTRIES LTD 15794 AMIODARONE HCL USP 2001-12-27 Active II N/A