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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 04/06/2025 | Xellia Pharmaceuticals ApS |
Denmark |
XELLIA PHARMACEUTICALS APS | 13362 | COLISTIN SULFATE | 1998-09-01 | Active | II | Complete | 2014-06-16 | 2012-11-15 |
| 04/06/2025 | DUMEX ALPHARMA AS |
Gabon |
DUMEX ALPHARMA AS | 14424 | COLISTIN SULFATE MONOCOMPONENT | 1999-10-21 | Inactive | II | N/A |
