FDA — authorised 9 August 2016
- Application: NDA022445
- Marketing authorisation holder: HERON THERAPS INC
- Local brand name: SUSTOL
- Indication: INJECTABLE — SUBCUTANEOUS
- Status: approved
🇺🇸 SUSTOL in United States
FDA authorised SUSTOL on 9 August 2016
Marketing authorisations
FDA
- Status: approved
SUSTOL 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 SUSTOL approved in United States?
Yes. FDA authorised it on 9 August 2016; FDA has authorised it.
Who is the marketing authorisation holder for SUSTOL in United States?
HERON THERAPS INC holds the US marketing authorisation.