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

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$ API Ref.Price (USD/KG) : 942Xls 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 Biophore India Pharmaceuticals Pvt Ltd
India
BIOPHORE INDIA PHARMACEUTICALS PVT LTD 26446 ZILEUTON 2012-09-26 Active II Complete 2014-06-16 2014-06-05
26/09/2024 Emcure Pharmaceuticals
India
EMCURE PHARMACEUTICALS LTD 25805 ZILEUTON USP 2012-03-26 Active II Complete 2016-12-09 2016-10-17