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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
24/02/2025 Medichem S.A
Spain
MEDICHEM MANUFACTURING MALTA LTD 21443 MED-201950/E (VORICONAZOLE) 2008-03-18 Active II Complete 2013-02-08 2012-11-26
24/02/2025 Neuland Laboratories
India
NEULAND LABORATORIES LTD 23697 VORICONAZOLE USP 2010-04-07 Active II N/A