Application 022410

Type: NDA
Sponsor: INDIVIOR INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SUBOXONE	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	FILM;BUCCAL, SUBLINGUAL	EQ 2MG BASE;EQ 0.5MG BASE	Yes	No
002	SUBOXONE	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	FILM;BUCCAL, SUBLINGUAL	EQ 8MG BASE;EQ 2MG BASE	Yes	No
003	SUBOXONE	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	FILM;BUCCAL, SUBLINGUAL	EQ 4MG BASE;EQ 1MG BASE	Yes	No
004	SUBOXONE	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	FILM;BUCCAL, SUBLINGUAL	EQ 12MG BASE;EQ 3MG BASE	Yes	Yes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0781-7216	BUPRENORPHINE AND NALOXONE	buprenorphine hydrochloride, naloxone hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7216	BUPRENORPHINE AND NALOXONE	buprenorphine hydrochloride, naloxone hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7216	BUPRENORPHINE AND NALOXONE	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA AUTHORIZED GENERIC	Current
0781-7216	BUPRENORPHINE AND NALOXONE	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA AUTHORIZED GENERIC	Current
0781-7216	BUPRENORPHINE AND NALOXONE	buprenorphine hydrochloride, naloxone hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7216	BUPRENORPHINE AND NALOXONE	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA AUTHORIZED GENERIC	Current
0781-7216	BUPRENORPHINE AND NALOXONE	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA AUTHORIZED GENERIC	Current
0781-7216	BUPRENORPHINE AND NALOXONE	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA AUTHORIZED GENERIC	Current
0781-7227	BUPRENORPHINE AND NALOXONE	buprenorphine hydrochloride, naloxone hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7227	BUPRENORPHINE AND NALOXONE	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA AUTHORIZED GENERIC	Current
0781-7227	BUPRENORPHINE AND NALOXONE	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA AUTHORIZED GENERIC	Current
0781-7227	BUPRENORPHINE AND NALOXONE	buprenorphine hydrochloride, naloxone hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7227	BUPRENORPHINE AND NALOXONE	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA AUTHORIZED GENERIC	Current
0781-7227	BUPRENORPHINE AND NALOXONE	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA AUTHORIZED GENERIC	Current
0781-7227	BUPRENORPHINE AND NALOXONE	buprenorphine hydrochloride, naloxone hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7227	BUPRENORPHINE AND NALOXONE	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA AUTHORIZED GENERIC	Current
0781-7238	BUPRENORPHINE AND NALOXONE	buprenorphine hydrochloride, naloxone hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7238	BUPRENORPHINE AND NALOXONE	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA AUTHORIZED GENERIC	Current
0781-7238	BUPRENORPHINE AND NALOXONE	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA AUTHORIZED GENERIC	Current
0781-7238	BUPRENORPHINE AND NALOXONE	buprenorphine hydrochloride, naloxone hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7238	BUPRENORPHINE AND NALOXONE	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA AUTHORIZED GENERIC	Current
0781-7238	BUPRENORPHINE AND NALOXONE	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA AUTHORIZED GENERIC	Current
0781-7238	BUPRENORPHINE AND NALOXONE	buprenorphine hydrochloride, naloxone hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7238	BUPRENORPHINE AND NALOXONE	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA AUTHORIZED GENERIC	Current
0781-7249	BUPRENORPHINE AND NALOXONE	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA AUTHORIZED GENERIC	Current
0781-7249	BUPRENORPHINE AND NALOXONE	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA AUTHORIZED GENERIC	Current
0781-7249	BUPRENORPHINE AND NALOXONE	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA AUTHORIZED GENERIC	Current
0781-7249	BUPRENORPHINE AND NALOXONE	buprenorphine hydrochloride, naloxone hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7249	BUPRENORPHINE AND NALOXONE	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA AUTHORIZED GENERIC	Current
0781-7249	BUPRENORPHINE AND NALOXONE	buprenorphine hydrochloride, naloxone hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7249	BUPRENORPHINE AND NALOXONE	buprenorphine hydrochloride, naloxone hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7249	BUPRENORPHINE AND NALOXONE	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA AUTHORIZED GENERIC	Current
12496-1202	Suboxone	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA	Current
12496-1202	Suboxone	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA	Current
12496-1202	Suboxone	buprenorphine hydrochloride, naloxone hydrochloride	INDIVIOR INC.	NDA	Current
12496-1202	Suboxone	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA	Current
12496-1202	Suboxone	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA	Current
12496-1202	Suboxone	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA	Current
12496-1202	Suboxone	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA	Current
12496-1202	Suboxone	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA	Current
12496-1202	Suboxone	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA	Current
12496-1204	Suboxone	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA	Current
12496-1204	Suboxone	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA	Current
12496-1204	Suboxone	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA	Current
12496-1204	Suboxone	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA	Current
12496-1204	Suboxone	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA	Current
12496-1204	Suboxone	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA	Current
12496-1204	Suboxone	buprenorphine hydrochloride, naloxone hydrochloride	INDIVIOR INC.	NDA	Current
12496-1204	Suboxone	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA	Current
12496-1204	Suboxone	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA	Current
12496-1208	Suboxone	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA	Current
12496-1208	Suboxone	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA	Current
12496-1208	Suboxone	buprenorphine hydrochloride, naloxone hydrochloride	INDIVIOR INC.	NDA	Current
12496-1208	Suboxone	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA	Current
12496-1208	Suboxone	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA	Current
12496-1208	Suboxone	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA	Current
12496-1208	Suboxone	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA	Current
12496-1208	Suboxone	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA	Current
12496-1208	Suboxone	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA	Current
12496-1212	Suboxone	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA	Current
12496-1212	Suboxone	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA	Current
12496-1212	Suboxone	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA	Current
12496-1212	Suboxone	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA	Current
12496-1212	Suboxone	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA	Current
12496-1212	Suboxone	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA	Current
12496-1212	Suboxone	buprenorphine hydrochloride, naloxone hydrochloride	INDIVIOR INC.	NDA	Current
12496-1212	Suboxone	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA	Current
12496-1212	Suboxone	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA	Current
53217-328	Suboxone	buprenorphine hydrochloride, naloxone hydrochloride	Aidarex Pharmaceuticals LLC	NDA	Current
55700-147	Suboxone	buprenorphine hydrochloride, naloxone hydrochloride	Quality Care Products, LLC	NDA	Current
63629-4028	Suboxone	buprenorphine and naloxone	Bryant Ranch Prepack	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84614	SUPPL	2025-12-31
84594	SUPPL	2025-12-29
82211	SUPPL	2025-05-21
82238	SUPPL	2025-05-19
81356	SUPPL	2025-02-25
77894	SUPPL	2024-03-21
76961	SUPPL	2023-12-18
76398	ORIG	2023-11-06
73757	SUPPL	2023-03-14
73744	SUPPL	2023-03-14
72978	SUPPL	2022-12-21
71394	SUPPL	2022-06-21
71393	SUPPL	2022-06-21
71392	SUPPL	2022-06-21
71370	SUPPL	2022-06-21
71369	SUPPL	2022-06-21
70986	SUPPL	2022-05-04
69380	SUPPL	2021-11-23
66619	SUPPL	2021-03-08
66618	SUPPL	2021-03-08
66566	SUPPL	2021-03-08
62028	SUPPL	2020-03-04
60769	SUPPL	2019-11-01
60763	SUPPL	2019-10-31
60475	SUPPL	2019-10-09
60474	SUPPL	2019-10-09
60443	SUPPL	2019-10-09
56141	SUPPL	2018-10-29
54621	SUPPL	2018-06-20
54610	SUPPL	2018-06-19
54593	SUPPL	2018-06-14
52288	SUPPL	2018-02-02
52245	SUPPL	2018-02-01
50046	APPL	2017-10-12
49839	SUPPL	2017-09-22
47248	SUPPL	2017-02-16
47196	SUPPL	2017-02-14
46380	SUPPL	2016-12-21
46379	SUPPL	2016-12-21
46335	SUPPL	2016-12-21
46334	SUPPL	2016-12-21
29699	SUPPL	2016-07-12
38673	SUPPL	2015-10-06
38672	SUPPL	2015-10-06
7347	SUPPL	2015-09-24
7346	SUPPL	2015-09-24
42515	SUPPL	2014-08-05
22015	SUPPL	2014-08-05
22014	SUPPL	2014-08-05
38671	SUPPL	2014-04-29
38670	SUPPL	2014-04-29
17556	SUPPL	2014-04-29
7345	SUPPL	2014-04-29
7344	SUPPL	2014-04-29
7342	SUPPL	2014-04-29
17555	SUPPL	2013-11-26
7343	SUPPL	2013-11-25
42514	SUPPL	2013-02-25
42513	SUPPL	2013-02-25
17554	SUPPL	2012-08-15
17553	SUPPL	2012-08-15
42512	ORIG	2011-08-12
24300	ORIG	2011-08-12
38669	ORIG	2010-09-10
7341	ORIG	2010-09-02