Duragesic-100, Duragesic-75, Duragesic-50

NDA 19813, held by Janssen Pharms. Fentanyl.

As of Nov 14, 2026, NDA 19813 (Duragesic-100, Duragesic-75, Duragesic-50), held by Janssen Pharms, was first approved by FDA on Aug 7, 1990, with 51 approved supplements and 0 published complete response letters.

First approved: Aug 7, 1990
Review: Standard
Supplements approved: 51
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 52 submissions below


Jan 24, 2018	Supplement 72Efficacy (new indication or use) · Standard review	Approved	Label
Feb 4, 2005	Supplement 39Efficacy (new indication or use)	Approved	Review Letter Label
May 20, 2003	Supplement 36Efficacy (new indication or use) · Priority review	Approved	Review Letter Label
Aug 7, 1990	Original applicationTYPE 2/3 · Standard review	Approved	Other Review Pediatric Medical Review Pediatric Written Request

Products

6 strengths and forms


Duragesic-100100MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · film, extended release;transdermal	Fentanyl	DiscontinuedReference drug
Duragesic-7575MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · film, extended release;transdermal	Fentanyl	DiscontinuedReference drug
Duragesic-5050MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · film, extended release;transdermal	Fentanyl	DiscontinuedReference drug
Duragesic-2525MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · film, extended release;transdermal	Fentanyl	DiscontinuedReference drug
Duragesic-1212.5MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · film, extended release;transdermal	Fentanyl	DiscontinuedReference drug
Duragesic-3737.5MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · film, extended release;transdermal	Fentanyl	DiscontinuedReference drug

All 52 submissions, including labeling and manufacturing supplements


Mar 4, 2021	Supplement 81Labeling · Standard review	Approved	Letter Label Medication Guide
Oct 7, 2019	Supplement 79Labeling · Standard review	Approved	Label Letter
Sep 18, 2018	Supplement 75REMS	Approved	Label Letter
Sep 18, 2018	Supplement 76Labeling · Standard review	Approved	Label Letter
Jan 24, 2018	Supplement 72Efficacy (new indication or use) · Standard review	Approved	Label
Jan 24, 2018	Supplement 73Manufacturing · Standard review	Approved	Label
May 26, 2017	Supplement 74REMS	Approved	Letter
Feb 10, 2017	Supplement 68Labeling · Standard review	Approved	Letter
Feb 2, 2017	Supplement 70Labeling · Standard review	Approved	Letter
Dec 16, 2016	Supplement 69Labeling · Standard review	Approved	Label Letter
Sep 30, 2016	Supplement 71REMS	Approved	Letter
Apr 20, 2016	Supplement 67REMS	Approved	Letter
Jun 26, 2015	Supplement 66REMS	Approved	Letter
Aug 19, 2014	Supplement 65REMS	Approved	Letter
Jun 8, 2014	Supplement 64Manufacturing · Standard review	Approved	None posted
Apr 16, 2014	Supplement 63Labeling	Approved	Letter Label
Sep 23, 2013	Supplement 60Manufacturing	Approved	Letter Label
Jul 26, 2013	Supplement 59Manufacturing · Standard review	Approved	None posted
Apr 15, 2013	Supplement 56REMS	Approved	Letter
Dec 19, 2012	Supplement 55Manufacturing · Standard review	Approved	None posted
Jul 9, 2012	Supplement 52REMS	Approved	Label Letter
Jul 9, 2012	Supplement 51Labeling · Standard review	Approved	Letter
Jul 31, 2009	Supplement 44Manufacturing	Approved	Review Label
Feb 7, 2008	Supplement 33Labeling · Standard review	Approved	Review Letter Label
Feb 4, 2005	Supplement 39Efficacy (new indication or use)	Approved	Review Letter Label
May 20, 2003	Supplement 36Efficacy (new indication or use) · Priority review	Approved	Review Letter Label
Apr 11, 2001	Supplement 23Labeling · Standard review	Approved	Review Letter
Apr 9, 2001	Supplement 30Labeling · Standard review	Approved	Review Letter
Nov 9, 2000	Supplement 29Manufacturing · Standard review	Approved	None posted
Nov 9, 2000	Supplement 28Manufacturing · Standard review	Approved	None posted
Nov 1, 2000	Supplement 26Labeling · Standard review	Approved	Review
Nov 1, 2000	Supplement 25Labeling · Standard review	Approved	Review
Apr 26, 2000	Supplement 27Manufacturing · Standard review	Approved	None posted
Dec 7, 1999	Supplement 22Manufacturing · Standard review	Approved	None posted
Dec 2, 1999	Supplement 24Manufacturing · Standard review	Approved	None posted
Jul 17, 1997	Supplement 21Labeling · Standard review	Approved	Review
Jul 17, 1997	Supplement 20Labeling · Standard review	Approved	Review
Jul 17, 1997	Supplement 19Labeling · Standard review	Approved	Review
Jul 17, 1997	Supplement 18Labeling · Standard review	Approved	Review
Jun 19, 1997	Supplement 15Manufacturing · Standard review	Approved	None posted
Nov 7, 1994	Supplement 17Labeling · Standard review	Approved	None posted
Mar 29, 1994	Supplement 16Labeling · Standard review	Approved	None posted
Jan 11, 1994	Supplement 14Labeling · Standard review	Approved	None posted
Oct 25, 1993	Supplement 12Labeling · Standard review	Approved	None posted
Jul 28, 1993	Supplement 10Labeling · Standard review	Approved	None posted
Jun 11, 1993	Supplement 11Manufacturing · Standard review	Approved	None posted
Jul 5, 1991	Supplement 8Manufacturing · Standard review	Approved	None posted
Jun 12, 1991	Supplement 9Manufacturing · Standard review	Approved	None posted
Feb 12, 1991	Supplement 7Manufacturing · Standard review	Approved	None posted
Oct 22, 1990	Supplement 6Manufacturing · Standard review	Approved	None posted
Oct 22, 1990	Supplement 1Manufacturing · Standard review	Approved	None posted
Aug 7, 1990	Original applicationTYPE 2/3 · Standard review	Approved	Other Review Pediatric Medical Review Pediatric Written Request

Show all 52

Identifiers

Application: NDA 19813
Drugs@FDA: Overview at FDA
Company: Janssen Pharmaceuticals, Inc.

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