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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 ChemWerth Inc
U.S.A
CHEMWERTH INC 22033 TIAGABINE HYDROCHLORIDE 2008-09-23 Active II Complete 2014-02-05 2013-11-26
28/03/2025 MSN Laboratories
India
MSN LIFE SCIENCES PRIVATE LTD 33494 TIAGABINE HYDROCHLORIDE USP 2018-12-31 Active II Complete 2019-11-06 2019-09-25