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List of Drug Master Files (DMF) of Apalutamide 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 Dr. Reddy\\\'s Laboratories
India
DR REDDYS LABORATORIES LTD 34667 APALUTAMIDE 2020-03-24 Active II Complete 2020-10-28 2020-09-30
26/09/2024 Porton Pharma Solutions
China
PORTON PHARMA SOLUTIONS LTD 39029 APALUTAMIDE 2023-11-02 Active II N/A