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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
28/10/2024 Medichem S.A
Spain
MEDICHEM MANUFACTURING MALTA LTD 28781 AMBRISENTAN (MED-200028/M) 2014-11-18 Active II Complete 2014-12-18 2014-11-19
28/10/2024 Actavis Inc
Ireland
WATSON PHARMA PRIVATE LTD 25134 AMBRISENTAN 2011-09-09 Inactive II N/A