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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 Medichem S.A
Spain
MEDICHEM SA 8590 GUANFACINE HYDROCHLORIDE 1990-06-12 Active II Complete 2013-02-26 2013-02-05
28/03/2025 Jubilant Generics
India
JUBILANT PHARMOVA LTD 28049 GUANFACINE HYDROCHLORIDE USP 2014-03-07 Active II Complete 2016-11-18 2016-08-23