Actiq

NDA 20747, held by Cephalon. Fentanyl Citrate.

As of Nov 13, 2026, NDA 20747 (Actiq), held by Cephalon, was first approved by FDA on Nov 4, 1998, with 34 approved supplements and 0 published complete response letters.

First approved: Nov 4, 1998
Review: Standard
Supplements approved: 34
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 35 submissions below


Feb 7, 2007	Supplement 27Efficacy (new indication or use) · Priority review	Approved	Label Letter
Nov 4, 1998	Original applicationNew dosage form · Standard review	Approved	Other Review Letter Label

Products

6 strengths and forms


ActiqEQ 0.2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · troche/lozenge;transmucosal	Fentanyl Citrate	DiscontinuedReference drug
ActiqEQ 0.4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · troche/lozenge;transmucosal	Fentanyl Citrate	DiscontinuedReference drug
ActiqEQ 0.6MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · troche/lozenge;transmucosal	Fentanyl Citrate	DiscontinuedReference drug
ActiqEQ 0.8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · troche/lozenge;transmucosal	Fentanyl Citrate	DiscontinuedReference drug
ActiqEQ 1.2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · troche/lozenge;transmucosal	Fentanyl Citrate	DiscontinuedReference drug
ActiqEQ 1.6MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · troche/lozenge;transmucosal	Fentanyl Citrate	DiscontinuedReference drug

All 35 submissions, including labeling and manufacturing supplements


Dec 22, 2025	Supplement 65Labeling · Standard review	Approved	Label Letter
Aug 28, 2024	Supplement 64REMS	Approved	Letter
Dec 15, 2023	Supplement 62Labeling · Standard review	Approved	Letter Label Medication Guide
Dec 8, 2022	Supplement 61REMS	Approved	Letter
Nov 22, 2022	Supplement 56REMS	Approved	Letter Label
Aug 17, 2022	Supplement 58REMS	Approved	Letter
Dec 3, 2021	Supplement 55REMS	Approved	Letter
Mar 4, 2021	Supplement 53Labeling · Standard review	Approved	Letter Label
Dec 23, 2020	Supplement 50REMS	Approved	Review Letter
Oct 7, 2019	Supplement 49Labeling · Standard review	Approved	Letter Label
Sep 7, 2017	Supplement 47REMS	Approved	Letter
Dec 16, 2016	Supplement 44Labeling · Standard review	Approved	Label Letter
Dec 16, 2016	Supplement 43Labeling · Standard review	Approved	Label Letter
Dec 24, 2014	Supplement 41REMS	Approved	Letter
Apr 30, 2014	Supplement 40Manufacturing · Standard review	Approved	None posted
Nov 7, 2013	Supplement 37REMS	Approved	Letter
Apr 22, 2013	Supplement 39Manufacturing · Standard review	Approved	None posted
Jun 5, 2012	Supplement 34REMS	Approved	Label Letter
Dec 28, 2011	Supplement 33REMS	Approved	Letter Label
Jul 20, 2011	Supplement 29Labeling · Standard review	Approved	Label Letter
Nov 9, 2009	Supplement 30Labeling · Standard review	Approved	Letter Label
Feb 7, 2007	Supplement 27Efficacy (new indication or use) · Priority review	Approved	Label Letter
Sep 6, 2006	Supplement 23Labeling · Standard review	Approved	Letter Label
Sep 9, 2005	Supplement 19Manufacturing · Standard review	Approved	Review Letter Label
Jan 19, 2005	Supplement 18Labeling · Standard review	Approved	Letter
Sep 24, 2004	Supplement 17Labeling · Standard review	Approved	Letter Label
Feb 19, 2003	Supplement 8Manufacturing · Standard review	Approved	Letter
Jan 29, 2003	Supplement 9Labeling · Standard review	Approved	Letter
Jun 10, 2002	Supplement 11Labeling · Standard review	Approved	Letter
Mar 12, 2002	Supplement 10Labeling · Standard review	Approved	Letter
Apr 9, 2001	Supplement 6Manufacturing · Standard review	Approved	Letter
Aug 25, 2000	Supplement 4Manufacturing · Standard review	Approved	None posted
Mar 26, 1999	Supplement 3Labeling · Standard review	Approved	Review
Mar 26, 1999	Supplement 2Labeling · Standard review	Approved	None posted
Nov 4, 1998	Original applicationNew dosage form · Standard review	Approved	Other Review Letter Label

Identifiers

Application: NDA 20747
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