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List of Drug Master Files (DMF) of Dexrazoxane 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 Porton Pharma Solutions
China
PORTON PHARMA SOLUTIONS LTD 38186 DEXRAZOXANE 2023-03-17 Active II N/A
26/09/2024 Alcami
U.S.A
STERLING WISCONSIN LLC 18336 DEXRAZOXANE (FP-048) 2005-05-09 Active II N/A