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

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$ API Ref.Price (USD/KG) : 221Xls 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 Lunan Pharmaceutical
China
SHANDONG NEW TIME PHARMACEUTICAL CO LTD 36615 TEGAFUR 2021-12-20 Active II N/A
26/09/2024 Taiho Pharmaceutical
Japan
TAIHO PHARMACEUTICAL CO INC 10400 UFT CAPSULES (TEGAFUR AND URACIL) 1993-06-17 Inactive II N/A