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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 |
---|---|---|---|---|---|---|---|---|---|---|---|
28/11/2024 | Fermion Oy |
Finland |
FERMION OY | 13810 | DEXMEDETOMIDINE HYDROCHLORIDE | 1998-10-30 | Active | II | Complete | 2021-08-31 | 2021-08-26 |
28/11/2024 | ChemWerth Inc |
U.S.A |
CHEMWERTH INC | 24202 | DEXMEDETOMIDINE HCL | 2011-12-15 | Active | II | Complete | 2013-03-27 | 2012-12-17 |
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