FDA — authorised 30 April 1990
- Application: ANDA070636
- Marketing authorisation holder: ABBOTT
- Local brand name: FENTANYL CITRATE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Fentanyl Buccal Tablet (FBT) in United States
FDA authorised Fentanyl Buccal Tablet (FBT) on 30 April 1990
Marketing authorisations
FDA — authorised 30 April 1990
- Application: ANDA070637
- Marketing authorisation holder: ABBOTT
- Local brand name: FENTANYL CITRATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 24 September 1991
- Application: ANDA072786
- Marketing authorisation holder: HOSPIRA
- Local brand name: FENTANYL CITRATE PRESERVATIVE FREE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 3 February 1998
- Application: ANDA074917
- Marketing authorisation holder: DR REDDYS
- Local brand name: FENTANYL CITRATE PRESERVATIVE FREE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 30 October 2009
- Application: ANDA078907
- Marketing authorisation holder: SPECGX LLC
- Local brand name: FENTANYL CITRATE
- Indication: TROCHE/LOZENGE — TRANSMUCOSAL
- Status: approved
FDA — authorised 30 October 2009
- Application: ANDA077312
- Marketing authorisation holder: PAR PHARM
- Local brand name: FENTANYL CITRATE
- Indication: TROCHE/LOZENGE — TRANSMUCOSAL
- Status: approved
FDA — authorised 3 May 2019
- Application: ANDA210762
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: FENTANYL CITRATE PRESERVATIVE FREE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 1 September 2020
- Application: ANDA212086
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: FENTANYL CITRATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 22 August 2022
- Application: ANDA206329
- Marketing authorisation holder: DR REDDYS LABS SA
- Local brand name: FENTANYL CITRATE
- Indication: TABLET — BUCCAL, SUBLINGUAL
- Status: approved
FDA
- Application: ANDA073488
- Marketing authorisation holder: WATSON LABS
- Local brand name: FENTANYL CITRATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Status: approved
Fentanyl Buccal Tablet (FBT) in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is Fentanyl Buccal Tablet (FBT) approved in United States?
Yes. FDA authorised it on 30 April 1990; FDA authorised it on 30 April 1990; FDA authorised it on 24 September 1991.
Who is the marketing authorisation holder for Fentanyl Buccal Tablet (FBT) in United States?
ABBOTT holds the US marketing authorisation.