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List of Drug Master Files (DMF) of Brimonidine 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 FARMAK, a.s
Czech Republic
FARMAK AS 15585 BRIMONIDINE TARTRATE 2001-08-15 Active II Complete 2012-10-26 2012-12-19
26/09/2024 Medichem S.A
Spain
MEDICHEM SA 15601 BRIMONIDINE TARTRATE 2001-08-27 Active II Complete 2012-12-26 2012-11-23