FDA — authorised 4 November 1998
- Application: NDA020747
- Marketing authorisation holder: CEPHALON
- Local brand name: ACTIQ
- Indication: TROCHE/LOZENGE — TRANSMUCOSAL
- Status: approved
🇺🇸 Fentanyl load in United States
FDA authorised Fentanyl load on 4 November 1998
Marketing authorisations
FDA — authorised 16 July 2009
- Application: NDA022266
- Marketing authorisation holder: ADALVO
- Local brand name: ONSOLIS
- Indication: FILM — BUCCAL
- Status: approved
FDA — authorised 7 January 2011
- Application: NDA022510
- Marketing authorisation holder: SENTYNL THERAPS INC
- Local brand name: ABSTRAL
- Indication: TABLET — SUBLINGUAL
- Status: approved
FDA
- Status: approved
Fentanyl load 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 Fentanyl load approved in United States?
Yes. FDA authorised it on 4 November 1998; FDA authorised it on 16 July 2009; FDA authorised it on 7 January 2011.
Who is the marketing authorisation holder for Fentanyl load in United States?
CEPHALON holds the US marketing authorisation.