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

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$ API Ref.Price (USD/KG) : 17,123Xls 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 Curia
U.S.A
CURIA WISCONSIN INC 27250 FLUOXYMESTERONE ACTIVE DRUG SUBSTANCE 2013-06-21 Active II Complete 2014-01-06 2013-07-08
26/09/2024 Pfizer Inc
U.S.A
PFIZER INC 4607 FLUOXYMESTERONE USP 1982-07-23 Inactive II N/A