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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 | ICE Pharma |
Italy |
ICE SPA | 16803 | URSODIOL | 2003-09-03 | Active | II | Complete | 2019-03-25 | 2019-02-14 |
| 28/03/2025 | Adare Pharma Solutions |
U.S.A |
AXCAN PHARMA INC | 17717 | URSODIOL SUSPENSION, 250 MG/ML | 2004-10-19 | Inactive | II | N/A |
