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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 |
---|---|---|---|---|---|---|---|---|---|---|---|
29/07/2025 | Inke S.A |
Spain |
INKE SA | 23914 | SALMETEROL XINAFOATE | 2010-06-23 | Active | II | Complete | 2015-08-12 | 2015-05-20 |
29/07/2025 | Gangwal Healthcare |
India |
GANGWAL HEALTHCARE PRIVATE LTD | 26863 | SALMETEROL XINAFOATE IP/BP | 2013-02-04 | Active | II | N/A |