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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 Fermion Oy
Finland
FERMION OY 13810 DEXMEDETOMIDINE HYDROCHLORIDE 1998-10-30 Active II Complete 2021-08-31 2021-08-26
28/03/2025 ChemWerth Inc
U.S.A
CHEMWERTH INC 24202 DEXMEDETOMIDINE HCL 2011-12-15 Active II Complete 2013-03-27 2012-12-17