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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 Cohance Lifesciences
India
COHANCE LIFESCIENCES LTD 25986 ITRACONAZOLE USP 2012-04-20 Active II Complete 2013-10-19 2013-03-11
28/03/2025 Neuland Laboratories
India
NEULAND LABORATORIES LTD 15445 ITRACONAZOLE USP 2001-05-15 Active II Complete 2014-02-12 2013-06-19