Data in the table can be downloaded after upgrading. In the meantime, you can access the data through the menu.
| Last Updated on PharmaCompass | Virtual Booth | Country | Holder | DMF No. | Subject | Submission Date | Status | Type | GDUFA DMF Review | GDUFA Review Date | GDUFA Payment Date |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 28/10/2024 | ICE Pharma |
Italy |
ICE SPA | 16803 | URSODIOL | 2003-09-03 | Active | II | Complete | 2019-03-25 | 2019-02-14 |
| 28/10/2024 | Sichuan Elixir Pharmaceuticals |
China |
SICHUAN ELIXIR PHARMACEUTICAL CO LTD | 39647 | URSODIOL | 2024-03-27 | Active | II | N/A |
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