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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 31/10/2025 | TAPI Technology & API Services |
Israel |
TAPI NL BV | 15742 | FLUDARABINE PHOSPHATE | 2001-11-12 | Active | II | Complete | 2012-12-24 | 2012-12-03 |
| 31/10/2025 | Archimica |
Italy |
EUTICALS SPA | 17374 | FLUDARABINE PHOSPHATE | 2004-05-13 | Inactive | II | N/A |
