Application 202788

Type: NDA
Sponsor: BTCP PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SUBSYS	FENTANYL	SPRAY;SUBLINGUAL	0.1MG	Yes	No
002	SUBSYS	FENTANYL	SPRAY;SUBLINGUAL	0.2MG	Yes	No
003	SUBSYS	FENTANYL	SPRAY;SUBLINGUAL	0.4MG	Yes	Yes
004	SUBSYS	FENTANYL	SPRAY;SUBLINGUAL	0.6MG	Yes	No
005	SUBSYS	FENTANYL	SPRAY;SUBLINGUAL	0.8MG	Yes	No
006	SUBSYS	FENTANYL	SPRAY;SUBLINGUAL	1.2MG	Yes	No
007	SUBSYS	FENTANYL	SPRAY;SUBLINGUAL	1.6MG	Yes	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
20482-001	SUBSYS	fentanyl	Insys Therapeutics, Inc.	NDA	Current
20482-001	SUBSYS	fentanyl	Insys Therapeutics, Inc.	NDA	Current
20482-001	SUBSYS	fentanyl	Insys Therapeutics, Inc.	NDA	Current
20482-001	SUBSYS	fentanyl	Insys Therapeutics, Inc.	NDA	Current
20482-001	SUBSYS	fentanyl	Insys Therapeutics, Inc.	NDA	Current
20482-002	SUBSYS	fentanyl	Insys Therapeutics, Inc.	NDA	Current
20482-002	SUBSYS	fentanyl	Insys Therapeutics, Inc.	NDA	Current
20482-002	SUBSYS	fentanyl	Insys Therapeutics, Inc.	NDA	Current
20482-002	SUBSYS	fentanyl	Insys Therapeutics, Inc.	NDA	Current
20482-002	SUBSYS	fentanyl	Insys Therapeutics, Inc.	NDA	Current
20482-004	SUBSYS	fentanyl	Insys Therapeutics, Inc.	NDA	Current
20482-004	SUBSYS	fentanyl	Insys Therapeutics, Inc.	NDA	Current
20482-004	SUBSYS	fentanyl	Insys Therapeutics, Inc.	NDA	Current
20482-004	SUBSYS	fentanyl	Insys Therapeutics, Inc.	NDA	Current
20482-004	SUBSYS	fentanyl	Insys Therapeutics, Inc.	NDA	Current
20482-006	SUBSYS	fentanyl	Insys Therapeutics, Inc.	NDA	Current
20482-006	SUBSYS	fentanyl	Insys Therapeutics, Inc.	NDA	Current
20482-006	SUBSYS	fentanyl	Insys Therapeutics, Inc.	NDA	Current
20482-006	SUBSYS	fentanyl	Insys Therapeutics, Inc.	NDA	Current
20482-006	SUBSYS	fentanyl	Insys Therapeutics, Inc.	NDA	Current
20482-008	SUBSYS	fentanyl	Insys Therapeutics, Inc.	NDA	Current
20482-008	SUBSYS	fentanyl	Insys Therapeutics, Inc.	NDA	Current
20482-008	SUBSYS	fentanyl	Insys Therapeutics, Inc.	NDA	Current
20482-008	SUBSYS	fentanyl	Insys Therapeutics, Inc.	NDA	Current
20482-008	SUBSYS	fentanyl	Insys Therapeutics, Inc.	NDA	Current
20482-012	SUBSYS	fentanyl	Insys Therapeutics, Inc.	NDA	Current
20482-012	SUBSYS	fentanyl	Insys Therapeutics, Inc.	NDA	Current
20482-012	SUBSYS	fentanyl	Insys Therapeutics, Inc.	NDA	Current
20482-012	SUBSYS	fentanyl	Insys Therapeutics, Inc.	NDA	Current
20482-012	SUBSYS	fentanyl	Insys Therapeutics, Inc.	NDA	Current
20482-016	SUBSYS	fentanyl	Insys Therapeutics, Inc.	NDA	Current
20482-016	SUBSYS	fentanyl	Insys Therapeutics, Inc.	NDA	Current
20482-016	SUBSYS	fentanyl	Insys Therapeutics, Inc.	NDA	Current
20482-016	SUBSYS	fentanyl	Insys Therapeutics, Inc.	NDA	Current
20482-016	SUBSYS	fentanyl	Insys Therapeutics, Inc.	NDA	Current
71500-001	SUBSYS	fentanyl	West Therapeutics Development, LLC	NDA	Current
71500-001	SUBSYS	fentanyl	West Therapeutics Development, LLC	NDA	Current
71500-001	SUBSYS	fentanyl	West Therapeutics Development, LLC	NDA	Current
71500-002	SUBSYS	fentanyl	West Therapeutics Development, LLC	NDA	Current
71500-002	SUBSYS	fentanyl	West Therapeutics Development, LLC	NDA	Current
71500-002	SUBSYS	fentanyl	West Therapeutics Development, LLC	NDA	Current
71500-004	SUBSYS	fentanyl	West Therapeutics Development, LLC	NDA	Current
71500-004	SUBSYS	fentanyl	West Therapeutics Development, LLC	NDA	Current
71500-004	SUBSYS	fentanyl	West Therapeutics Development, LLC	NDA	Current
71500-006	SUBSYS	fentanyl	West Therapeutics Development, LLC	NDA	Current
71500-006	SUBSYS	fentanyl	West Therapeutics Development, LLC	NDA	Current
71500-006	SUBSYS	fentanyl	West Therapeutics Development, LLC	NDA	Current
71500-008	SUBSYS	fentanyl	West Therapeutics Development, LLC	NDA	Current
71500-008	SUBSYS	fentanyl	West Therapeutics Development, LLC	NDA	Current
71500-008	SUBSYS	fentanyl	West Therapeutics Development, LLC	NDA	Current
71500-012	SUBSYS	fentanyl	West Therapeutics Development, LLC	NDA	Current
71500-012	SUBSYS	fentanyl	West Therapeutics Development, LLC	NDA	Current
71500-012	SUBSYS	fentanyl	West Therapeutics Development, LLC	NDA	Current
71500-016	SUBSYS	fentanyl	West Therapeutics Development, LLC	NDA	Current
71500-016	SUBSYS	fentanyl	West Therapeutics Development, LLC	NDA	Current
71500-016	SUBSYS	fentanyl	West Therapeutics Development, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
72850	SUPPL	2022-12-09
71843	SUPPL	2022-08-18
69499	SUPPL	2021-12-07
66643	SUPPL	2021-03-08
66642	SUPPL	2021-03-08
66577	SUPPL	2021-03-08
65763	SUPPL	2020-12-28
60500	SUPPL	2019-10-09
60499	SUPPL	2019-10-09
60454	SUPPL	2019-10-09
49716	SUPPL	2017-09-11
46597	SUPPL	2016-12-30
46429	SUPPL	2016-12-21
46302	SUPPL	2016-12-20
40218	SUPPL	2015-01-09
19377	SUPPL	2015-01-09
19376	SUPPL	2015-01-09
32303	SUPPL	2014-12-31
10109	SUPPL	2014-12-31
10107	SUPPL	2014-12-31
10108	SUPPL	2013-11-12
40217	SUPPL	2013-08-09
40216	SUPPL	2013-08-09
32302	SUPPL	2013-08-05
10106	SUPPL	2013-08-05
44865	ORIG	2012-09-06
22896	ORIG	2012-09-06
32300	SUPPL	2012-09-04
19375	SUPPL	2012-08-31
24105	ORIG	2012-06-15
40215	SUPPL	2012-06-11
40214	SUPPL	2012-06-11
32301	SUPPL	2012-06-07
32299	SUPPL	2012-06-07
24106	ORIG	2012-02-01
40213	ORIG	2012-01-06
32298	ORIG	2012-01-06