Fentora

NDA 21947, held by Cephalon. Fentanyl Citrate.

As of Nov 14, 2026, NDA 21947 (Fentora), held by Cephalon, was first approved by FDA on Sep 25, 2006, with 28 approved supplements and 0 published complete response letters.

First approved: Sep 25, 2006
Review: Standard
Supplements approved: 28
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 29 submissions below


Feb 21, 2013	Supplement 8Efficacy (new indication or use) · Standard review	Approved	Label Letter
Sep 25, 2006	Original applicationNew dosage form · Standard review	Approved	Other Review Letter Label

Products

6 strengths and forms


FentoraEQ 0.1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;buccal, sublingual	Fentanyl Citrate	DiscontinuedReference drug
FentoraEQ 0.2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;buccal, sublingual	Fentanyl Citrate	DiscontinuedReference drug
FentoraEQ 0.4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;buccal, sublingual	Fentanyl Citrate	DiscontinuedReference drug
FentoraEQ 0.6MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;buccal, sublingual	Fentanyl Citrate	DiscontinuedReference drug
FentoraEQ 0.8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;buccal, sublingual	Fentanyl Citrate	DiscontinuedReference drug
FentoraEQ 0.3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;buccal, sublingual	Fentanyl Citrate	DiscontinuedReference drug

All 29 submissions, including labeling and manufacturing supplements


Dec 22, 2025	Supplement 46Labeling · Standard review	Approved	Label Letter
Aug 28, 2024	Supplement 45REMS	Approved	Letter
Dec 15, 2023	Supplement 43Labeling · Standard review	Approved	Letter Label Medication Guide
Dec 8, 2022	Supplement 42REMS	Approved	Letter
Nov 22, 2022	Supplement 38REMS	Approved	Letter Label
Aug 17, 2022	Supplement 40REMS	Approved	Letter
Dec 3, 2021	Supplement 37REMS	Approved	Letter
Mar 4, 2021	Supplement 34Labeling · Standard review	Approved	Label Letter
Dec 23, 2020	Supplement 30REMS	Approved	Letter
Oct 7, 2019	Supplement 29Labeling · Standard review	Approved	Letter Label
Sep 7, 2017	Supplement 27REMS	Approved	Letter
Apr 11, 2017	Supplement 19REMS	Approved	Letter Label
Jan 12, 2017	Supplement 26Manufacturing · Standard review	Approved	None posted
Dec 16, 2016	Supplement 25Labeling · Standard review	Approved	Label Letter
Dec 16, 2016	Supplement 24Labeling · Standard review	Approved	Label Letter
May 19, 2016	Supplement 14Manufacturing · Standard review	Approved	None posted
Dec 24, 2014	Supplement 22REMS	Approved	Letter
Aug 29, 2014	Supplement 21Manufacturing · Standard review	Approved	None posted
Nov 7, 2013	Supplement 17REMS	Approved	Letter
Feb 21, 2013	Supplement 8Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jun 5, 2012	Supplement 15REMS	Approved	Label Letter
Dec 28, 2011	Supplement 13REMS	Approved	Letter Label
Jul 20, 2011	Supplement 9Labeling · Standard review	Approved	Letter Label
Jan 20, 2011	Supplement 11Labeling · Standard review	Approved	Letter Label
Dec 2, 2009	Supplement 10Labeling · Standard review	Approved	Letter Label
Feb 7, 2008	Supplement 6Labeling · Standard review	Approved	Letter Label
Apr 27, 2007	Supplement 1Labeling · Standard review	Approved	Letter Label
Mar 2, 2007	Supplement 2Manufacturing	Approved	Label Letter
Sep 25, 2006	Original applicationNew dosage form · Standard review	Approved	Other Review Letter Label

Identifiers

Application: NDA 21947
Drugs@FDA: Overview at FDA
Company: Cephalon

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters