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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 |