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List of Drug Master Files (DMF) of Bromocriptine Mesylate 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 Curia
U.S.A
CURIA ITALY SRL 6955 BROMOCRIPTINE MESYLATE 1987-05-11 Active II N/A
26/09/2024 GALENA AS
Czech Republic
GALENA AS 11973 BROMOCRIPTINE MESYLATE 1996-05-06 Inactive II N/A