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List of Drug Master Files (DMF) of Ethionamide 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 Sanofi
France
RHONE POULENC RORER PHARMACEUTICALS INC 8010 ETHIONAMIDE SUPPOSITORIES, 500 MG, THERAPLIX SA, PARIS, FR 1989-04-03 Inactive II N/A
26/09/2024 AXYNTIS Group
France
ORGAPHARM SAS 23640 ETHIONAMIDE DRUG SUBSTANCE 2010-03-17 Active II N/A