FDA — authorised 4 November 2019
- Application: BLA761045
- Marketing authorisation holder: SANDOZ INC
- Local brand name: ZIEXTENZO
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 ZIEXTENZO in United States
FDA authorised ZIEXTENZO on 4 November 2019
Marketing authorisation
ZIEXTENZO in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is ZIEXTENZO approved in United States?
Yes. FDA authorised it on 4 November 2019.
Who is the marketing authorisation holder for ZIEXTENZO in United States?
SANDOZ INC holds the US marketing authorisation.