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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 | Archimica |
Italy |
ARCHIMICA SPA | 12754 | HYDROXYUREA | 1997-11-14 | Active | II | Complete | 2019-02-13 | 2019-02-08 |
| 28/03/2025 | Bristol Myers Squibb |
U.S.A |
BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE | 2452 | HYDREA | 1975-05-21 | Inactive | II | N/A |
