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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 |