FDA — authorised 12 May 2021
- Application: NDA211988
- Marketing authorisation holder: HERON THERAPS INC
- Status: supplemented
🇺🇸 Zynrelef in United States
FDA authorised Zynrelef on 12 May 2021
Marketing authorisations
FDA
- Status: approved
Zynrelef 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 Zynrelef approved in United States?
Yes. FDA authorised it on 12 May 2021; FDA has authorised it.
Who is the marketing authorisation holder for Zynrelef in United States?
HERON THERAPS INC holds the US marketing authorisation.