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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 Inke S.A
Spain
INKE SA 23914 SALMETEROL XINAFOATE 2010-06-23 Active II Complete 2015-08-12 2015-05-20
24/02/2025 Aarti Pharmalabs
India
AARTI PHARMALABS LTD 22054 SALMETEROL XINAFOATE 2008-10-03 Active II Complete 2016-07-05 2015-01-05