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List of Drug Master Files (DMF) of Prestwick2_001060 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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$ API Ref.Price (USD/KG) : 88Xls 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 China Chemical & Pharmaceutical
China
CHINA CHEMICAL SYNTHESIS INDUSTRIAL CO LTD 13119 OXAPROZIN (BULK ACTIVE PHARMACEUTICAL INGREDIENT) 1998-08-11 Inactive II N/A
26/09/2024 Cilag AG
Switzerland
CILAG AG 11867 OXAPROZIN 1996-02-28 Inactive II N/A