FDA — authorised 28 April 2022
- Application: NDA215760
- Marketing authorisation holder: ORPHALAN
- Local brand name: CUVRIOR
- Indication: TABLET — ORAL
- Status: approved
FDA authorised TETA 4HCL (60-<W108) on 28 April 2022
Yes. FDA authorised it on 28 April 2022.
ORPHALAN holds the US marketing authorisation.