Application 019813

Type: NDA
Sponsor: JANSSEN PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DURAGESIC-100	FENTANYL	FILM, EXTENDED RELEASE;TRANSDERMAL	100MCG/HR	Yes	No
002	DURAGESIC-75	FENTANYL	FILM, EXTENDED RELEASE;TRANSDERMAL	75MCG/HR	Yes	No
003	DURAGESIC-50	FENTANYL	FILM, EXTENDED RELEASE;TRANSDERMAL	50MCG/HR	Yes	No
004	DURAGESIC-25	FENTANYL	FILM, EXTENDED RELEASE;TRANSDERMAL	25MCG/HR	Yes	Yes
005	DURAGESIC-12	FENTANYL	FILM, EXTENDED RELEASE;TRANSDERMAL	12.5MCG/HR	Yes	No
006	DURAGESIC-37	FENTANYL	FILM, EXTENDED RELEASE;TRANSDERMAL	37.5MCG/HR	Yes	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0781-7240	Fentanyl	Fentanyl	Sandoz,Inc.	NDA	Current
0781-7241	Fentanyl	Fentanyl	Sandoz,Inc.	NDA	Current
0781-7242	Fentanyl	Fentanyl	Sandoz,Inc.	NDA	Current
0781-7243	Fentanyl	Fentanyl	Sandoz,Inc.	NDA	Current
0781-7244	Fentanyl	Fentanyl	Sandoz,Inc.	NDA	Current
50458-090	DURAGESIC	fentanyl	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-090	DURAGESIC	fentanyl	Janssen Pharmaceuticals,	NDA	Current
50458-090	DURAGESIC	fentanyl	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-091	DURAGESIC	fentanyl	Janssen Pharmaceuticals,	NDA	Current
50458-091	DURAGESIC	fentanyl	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-092	DURAGESIC	fentanyl	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-092	DURAGESIC	fentanyl	Janssen Pharmaceuticals,	NDA	Current
50458-092	DURAGESIC	fentanyl	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-093	DURAGESIC	fentanyl	Janssen Pharmaceuticals,	NDA	Current
50458-093	DURAGESIC	fentanyl	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-093	DURAGESIC	fentanyl	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-094	DURAGESIC	fentanyl	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-094	DURAGESIC	fentanyl	Janssen Pharmaceuticals,	NDA	Current
50458-094	DURAGESIC	fentanyl	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-101	DURAGESIC	fentanyl	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-101	DURAGESIC	fentanyl	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-101	DURAGESIC	fentanyl	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-101	DURAGESIC	fentanyl	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-101	DURAGESIC	fentanyl	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-101	DURAGESIC	fentanyl	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-102	DURAGESIC	fentanyl	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-102	DURAGESIC	fentanyl	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-102	DURAGESIC	fentanyl	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-102	DURAGESIC	fentanyl	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-102	DURAGESIC	fentanyl	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-102	DURAGESIC	fentanyl	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-104	DURAGESIC	fentanyl	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-104	DURAGESIC	fentanyl	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-104	DURAGESIC	fentanyl	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-104	DURAGESIC	fentanyl	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-104	DURAGESIC	fentanyl	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-104	DURAGESIC	fentanyl	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-105	DURAGESIC	fentanyl	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-105	DURAGESIC	fentanyl	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-105	DURAGESIC	fentanyl	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-105	DURAGESIC	fentanyl	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-105	DURAGESIC	fentanyl	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-105	DURAGESIC	fentanyl	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-106	DURAGESIC	fentanyl	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-106	DURAGESIC	fentanyl	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-106	DURAGESIC	fentanyl	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-106	DURAGESIC	fentanyl	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-106	DURAGESIC	fentanyl	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-106	DURAGESIC	fentanyl	Janssen Pharmaceuticals, Inc.	NDA	Current
63629-4765	Fentanyl	Fentanyl	Bryant Ranch Prepack	NDA	Current
68258-3040	Fentanyl	Fentanyl	Dispensing Solutions, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
66520	SUPPL	2021-03-05
66519	SUPPL	2021-03-05
66509	SUPPL	2021-03-05
60341	SUPPL	2019-10-08
60325	SUPPL	2019-10-08
60324	SUPPL	2019-10-08
55843	SUPPL	2018-10-05
55842	SUPPL	2018-10-05
55655	SUPPL	2018-09-28
55654	SUPPL	2018-09-28
51915	SUPPL	2018-01-26
51914	SUPPL	2018-01-26
48570	SUPPL	2017-05-30
47185	SUPPL	2017-02-13
47097	SUPPL	2017-02-03
46394	SUPPL	2016-12-21
46237	SUPPL	2016-12-20
45460	SUPPL	2016-10-04
19254	SUPPL	2016-04-22
19253	SUPPL	2015-07-02
19252	SUPPL	2014-08-20
1642	SUPPL	2014-04-17
33979	SUPPL	2014-04-16
19251	SUPPL	2013-10-09
11735	SUPPL	2013-09-24
19250	SUPPL	2013-04-16
20375	SUPPL	2012-10-12
20374	SUPPL	2012-09-17
33978	SUPPL	2012-07-12
23965	ORIG	2012-07-11
19249	SUPPL	2012-07-11
19248	SUPPL	2012-07-11
33977	SUPPL	2010-04-01
41042	SUPPL	2009-01-12
41041	SUPPL	2009-01-12
41040	SUPPL	2009-01-12
20373	SUPPL	2009-01-12
20372	SUPPL	2009-01-12
20371	SUPPL	2009-01-12
20368	ORIG	2008-02-19
33974	SUPPL	2008-02-14
1639	SUPPL	2008-02-14
41039	SUPPL	2007-07-09
41038	SUPPL	2007-07-09
20370	SUPPL	2007-07-09
20369	SUPPL	2007-07-09
23557	ORIG	2005-07-29
33976	SUPPL	2005-02-08
1641	SUPPL	2005-02-08
33975	SUPPL	2003-06-08
1640	SUPPL	2003-06-08
19247	SUPPL	2001-04-11
1638	SUPPL	2001-04-11
51855	ORIG	1900-01-01
51854	ORIG	1900-01-01
51853	ORIG	1900-01-01
51852	ORIG	1900-01-01
51851	ORIG	1900-01-01