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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
28/03/2025 Actylis
U.S.A
PHARMA-WALDHOF GMBH 4959 5-FLUORO-URACIL,PRODUCT 4965 1983-05-18 Inactive II N/A
28/03/2025 Amcol
U.S.A
AMCOL HEALTH AND BEAUTY SOLUTIONS INC 29443 POLY-PORE® FLUOROURACIL POLYMER 2015-11-13 Active II Complete 2017-07-07 2015-07-08