Application 020747

Type: NDA
Sponsor: CEPHALON

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ACTIQ	FENTANYL CITRATE	TROCHE/LOZENGE;TRANSMUCOSAL	EQ 0.2MG BASE	Yes	No
002	ACTIQ	FENTANYL CITRATE	TROCHE/LOZENGE;TRANSMUCOSAL	EQ 0.4MG BASE	Yes	Yes
003	ACTIQ	FENTANYL CITRATE	TROCHE/LOZENGE;TRANSMUCOSAL	EQ 0.6MG BASE	Yes	No
004	ACTIQ	FENTANYL CITRATE	TROCHE/LOZENGE;TRANSMUCOSAL	EQ 0.8MG BASE	Yes	No
005	ACTIQ	FENTANYL CITRATE	TROCHE/LOZENGE;TRANSMUCOSAL	EQ 1.2MG BASE	Yes	No
006	ACTIQ	FENTANYL CITRATE	TROCHE/LOZENGE;TRANSMUCOSAL	EQ 1.6MG BASE	Yes	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-7865	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7865	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7865	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7865	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7865	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7865	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7865	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7865	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7866	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7866	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7866	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7866	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7866	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7866	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7866	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7866	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7867	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7867	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7867	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7867	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7867	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7867	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7867	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7867	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7868	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7868	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7868	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7868	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7868	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7868	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7868	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7868	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7869	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7869	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7869	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7869	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7869	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7869	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7869	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7869	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7870	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7870	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7870	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7870	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7870	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7870	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7870	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-7870	Fentanyl Citrate	Fentanyl Citrate	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
52959-548	Transmucosal Fentanyl Citrate	fentanyl citrate	H.J. Harkins Company, Inc.	NDA	Current
52959-549	Transmucosal Fentanyl Citrate	fentanyl citrate	H.J. Harkins Company, Inc.	NDA	Current
52959-566	Transmucosal Fentanyl Citrate	fentanyl citrate	H.J. Harkins Company, Inc.	NDA	Current
63459-502	ACTIQ	Fentanyl Citrate	Cephalon, LLC	NDA	Current
63459-502	ACTIQ	Fentanyl Citrate	Cephalon, LLC	NDA	Current
63459-502	ACTIQ	Fentanyl Citrate	Cephalon, Inc.	NDA	Current
63459-502	ACTIQ	Fentanyl Citrate	Cephalon, Inc.	NDA	Current
63459-502	ACTIQ	Fentanyl Citrate	Cephalon, Inc.	NDA	Current
63459-502	ACTIQ	Fentanyl Citrate	Cephalon, LLC	NDA	Current
63459-502	ACTIQ	Fentanyl Citrate	Cephalon, Inc.	NDA	Current
63459-502	ACTIQ	Fentanyl Citrate	Cephalon, Inc.	NDA	Current
63459-504	ACTIQ	Fentanyl Citrate	Cephalon, LLC	NDA	Current
63459-504	ACTIQ	Fentanyl Citrate	Cephalon, Inc.	NDA	Current
63459-504	ACTIQ	Fentanyl Citrate	Cephalon, Inc.	NDA	Current
63459-504	ACTIQ	Fentanyl Citrate	Cephalon, LLC	NDA	Current
63459-504	ACTIQ	Fentanyl Citrate	Cephalon, Inc.	NDA	Current
63459-504	ACTIQ	Fentanyl Citrate	Cephalon, Inc.	NDA	Current
63459-504	ACTIQ	Fentanyl Citrate	Cephalon, Inc.	NDA	Current
63459-504	ACTIQ	Fentanyl Citrate	Cephalon, LLC	NDA	Current
63459-506	ACTIQ	Fentanyl Citrate	Cephalon, Inc.	NDA	Current
63459-506	ACTIQ	Fentanyl Citrate	Cephalon, Inc.	NDA	Current
63459-506	ACTIQ	Fentanyl Citrate	Cephalon, LLC	NDA	Current
63459-506	ACTIQ	Fentanyl Citrate	Cephalon, Inc.	NDA	Current
63459-506	ACTIQ	Fentanyl Citrate	Cephalon, Inc.	NDA	Current
63459-506	ACTIQ	Fentanyl Citrate	Cephalon, LLC	NDA	Current
63459-506	ACTIQ	Fentanyl Citrate	Cephalon, LLC	NDA	Current
63459-506	ACTIQ	Fentanyl Citrate	Cephalon, Inc.	NDA	Current
63459-508	ACTIQ	Fentanyl Citrate	Cephalon, LLC	NDA	Current
63459-508	ACTIQ	Fentanyl Citrate	Cephalon, LLC	NDA	Current
63459-508	ACTIQ	Fentanyl Citrate	Cephalon, Inc.	NDA	Current
63459-508	ACTIQ	Fentanyl Citrate	Cephalon, Inc.	NDA	Current
63459-508	ACTIQ	Fentanyl Citrate	Cephalon, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84672	SUPPL	2026-01-06
84565	SUPPL	2025-12-29
80159	SUPPL	2024-11-05
79500	SUPPL	2024-08-29
76997	SUPPL	2023-12-19
76900	SUPPL	2023-12-18
76899	SUPPL	2023-12-18
72853	SUPPL	2022-12-09
72707	SUPPL	2022-11-25
72682	SUPPL	2022-11-23
72681	SUPPL	2022-11-23
71844	SUPPL	2022-08-18
69493	SUPPL	2021-12-07
66589	SUPPL	2021-03-08
66588	SUPPL	2021-03-08
66564	SUPPL	2021-03-08
65765	SUPPL	2020-12-28
60488	SUPPL	2019-10-09
60487	SUPPL	2019-10-09
60426	SUPPL	2019-10-09
49710	SUPPL	2017-09-11
46365	SUPPL	2016-12-21
46364	SUPPL	2016-12-21
46268	SUPPL	2016-12-20
46267	SUPPL	2016-12-20
25696	SUPPL	2014-12-30
25695	SUPPL	2013-11-08
13340	SUPPL	2012-06-11
25694	SUPPL	2012-06-07
20895	SUPPL	2012-02-28
25693	SUPPL	2012-01-03
44460	ORIG	2011-12-30
35268	SUPPL	2011-12-28
25692	SUPPL	2011-07-21
13338	SUPPL	2011-07-21
3260	SUPPL	2010-01-20
13339	SUPPL	2009-11-13
20896	SUPPL	2008-07-30
25690	SUPPL	2007-04-11
13337	SUPPL	2007-02-21
25691	SUPPL	2007-02-12
35267	SUPPL	2006-09-12
35266	SUPPL	2005-09-15
25689	SUPPL	2005-09-15
25688	SUPPL	2005-01-26
13336	SUPPL	2004-09-29
3259	SUPPL	2004-09-29
3256	SUPPL	2003-02-19
25687	SUPPL	2003-01-29
3258	SUPPL	2002-06-10
3257	SUPPL	2002-03-07
25686	SUPPL	2001-04-11
41641	ORIG	2000-07-19
13335	ORIG	1998-11-04
3255	ORIG	1998-11-04