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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 Xellia Pharmaceuticals ApS
Denmark
XELLIA PHARMACEUTICALS APS 13362 COLISTIN SULFATE 1998-09-01 Active II Complete 2014-06-16 2012-11-15
28/03/2025 KAYAKU CO LTD 13289 COLISTIN SULFATE 1998-09-01 Inactive II N/A