FDA — authorised 25 October 2005
- Application: BLA021716
- Marketing authorisation holder: AKORN INC
- Local brand name: HYDASE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA authorised Hylase on 25 October 2005
Yes. FDA authorised it on 25 October 2005.
AKORN INC holds the US marketing authorisation.