🇺🇸 Fentanyl Buccal Tablet in United States

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

FDA authorised Fentanyl Buccal Tablet on 25 September 2006

Marketing authorisation

FDA — authorised 25 September 2006

Application: NDA021947
Marketing authorisation holder: CEPHALON
Local brand name: FENTORA
Indication: TABLET — BUCCAL, SUBLINGUAL
Status: approved

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Other Oncology approved in United States

Frequently asked questions

Is Fentanyl Buccal Tablet approved in United States?

Yes. FDA authorised it on 25 September 2006.

Who is the marketing authorisation holder for Fentanyl Buccal Tablet in United States?

CEPHALON holds the US marketing authorisation.