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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 Dr. Reddy\'s Laboratories
India
DR REDDYS LABORATORIES LTD 17779 DONEPEZIL HYDROCHLORIDE MONOHYDRATE (FORM-1) USP 2004-10-26 Active II Complete 2014-10-31 2014-10-27
28/03/2025 Neuland Laboratories
India
NEULAND LABORATORIES LTD 21132 DONEPEZIL HYDROCHLORIDE USP (FORM-I) 2007-12-11 Active II Complete 2020-01-28 2020-01-21