FDA — authorised 7 January 2011
- Application: NDA022510
- Marketing authorisation holder: SENTYNL THERAPS INC
- Local brand name: ABSTRAL
- Indication: TABLET — SUBLINGUAL
- Status: approved
🇺🇸 SL fentanyl in United States
FDA authorised SL fentanyl on 7 January 2011
Marketing authorisations
FDA
- Status: approved
SL fentanyl in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is SL fentanyl approved in United States?
Yes. FDA authorised it on 7 January 2011; FDA has authorised it.
Who is the marketing authorisation holder for SL fentanyl in United States?
SENTYNL THERAPS INC holds the US marketing authorisation.