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

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$ API Ref.Price (USD/KG) : 197Xls 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
28/10/2024 Johnson & Johnson Innovative Medicine
U.S.A
JANSSEN PHARMACEUTICA NV 5432 OXATOMIDE TABLETS 30 MG 1984-06-14 Inactive II N/A
28/10/2024 Johnson & Johnson Innovative Medicine
U.S.A
JANSSEN PHARMACEUTICA NV 5108 OXATOMIDE-R 35443 AS PROCESSED IN THE BELGIUM FACILITY 1983-09-09 Inactive II N/A