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 | Axplora |
Germany |
FINORGA SAS | 27182 | ICOSAPENT ETHYL | 2013-05-23 | Active | II | Complete | 2023-06-07 | 2023-06-05 |
| 28/10/2024 | Chunghwa Chemical Synthesis & Biotech |
Taiwan |
CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTD | 26271 | ETHYL ICOSAPENTATE | 2012-08-01 | Active | II | Complete | 2013-04-01 | 2012-11-20 |
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