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List of Drug Master Files (DMF) of Fludeoxyglucose F 18 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 GENERAL ELECTRIC
U.S.A
GENERAL ELECTRIC MEDICAL SYSTEMS 13268 FLUDEOXYGLUCOSE F-18 INJECTION 1998-06-04 Inactive II N/A
26/09/2024 HUAYI ISOTOPE CO
China
HUAYI ISOTOPES CO 30323 18F-FDG REAGENT KITS 2016-01-18 Active II N/A