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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 |