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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 | Medichem S.A |
Spain |
MEDICHEM MANUFACTURING MALTA LTD | 21443 | MED-201950/E (VORICONAZOLE) | 2008-03-18 | Active | II | Complete | 2013-02-08 | 2012-11-26 |
24/02/2025 | Neuland Laboratories |
India |
NEULAND LABORATORIES LTD | 23697 | VORICONAZOLE USP | 2010-04-07 | Active | II | N/A |