FDA — authorised 4 October 2019
- Application: NDA211415
- Marketing authorisation holder: ESTEVE
- Local brand name: QUZYTTIR
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA authorised JDP-205 Injection on 4 October 2019
Yes. FDA authorised it on 4 October 2019.
ESTEVE holds the US marketing authorisation.