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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
25/04/2025 Cambrex Corporation
U.S.A
CAMBREX KARLSKOGA AB 12679 ISOSORBIDE-5-MONONITRATE/LACTOSE 1997-10-02 Inactive II N/A
25/04/2025 Dipharma
Italy
DIPHARMA FRANCIS SRL 6778 ISOSORBIDE-5-MONONITRATE (5-ISMN) 1987-01-09 Active II Complete 2013-01-15 2012-12-24