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 | Nortec Quimica |
Brazil |
NORTEC QUIMICA SA | 37647 | ESKETAMINE HYDROCHLORIDE | 2022-12-09 | Active | II | Complete | 2023-02-22 | 2023-01-31 |
| 28/10/2024 | Seqens |
France |
CU CHEMIE UETIKON GMBH | 16737 | S-KETAMINE HYDROCHLORIDE | 2003-07-31 | Active | II | N/A |
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