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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 Medichem S.A
Spain
MEDICHEM SA 5827 CYCLOBENZAPRINE HCL 1985-05-10 Active II Complete 2015-06-23 2015-05-04
28/03/2025 Cilag AG
Switzerland
CILAG AG 8101 CYCLOBENZAPRINE HCL 1989-06-08 Inactive II N/A