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 | Inke S.A |
Spain |
INKE SA | 36481 | REVEFENACIN TRIHYDRATE | 2022-07-27 | Active | II | Complete | 2022-09-01 | 2022-03-17 |
| 28/10/2024 | Medichem S.A |
Spain |
MEDICHEM MANUFACTURING MALTA LTD | 36861 | REVEFENACIN | 2022-04-19 | Active | II | Complete | 2022-05-10 | 2022-04-11 |
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