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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 Olpha
Latvia
OLPHA AS 20543 MEMANTINE HYDROCHLORIDE 2007-05-09 Active II Complete 2013-02-07 2012-11-27
25/04/2025 Cohance Lifesciences
India
COHANCE LIFESCIENCES LTD 29180 MEMANTINE HYDROCHLORIDE USP 2015-03-16 Active II Complete 2019-04-22 2019-02-11