Application 207932

Type: NDA
Sponsor: BDSI

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BELBUCA	BUPRENORPHINE HYDROCHLORIDE	FILM;BUCCAL	EQ 0.075MG BASE	Yes	No
002	BELBUCA	BUPRENORPHINE HYDROCHLORIDE	FILM;BUCCAL	EQ 0.15MG BASE	Yes	No
003	BELBUCA	BUPRENORPHINE HYDROCHLORIDE	FILM;BUCCAL	EQ 0.3MG BASE	Yes	No
004	BELBUCA	BUPRENORPHINE HYDROCHLORIDE	FILM;BUCCAL	EQ 0.45MG BASE	Yes	No
005	BELBUCA	BUPRENORPHINE HYDROCHLORIDE	FILM;BUCCAL	EQ 0.6MG BASE	Yes	No
006	BELBUCA	BUPRENORPHINE HYDROCHLORIDE	FILM;BUCCAL	EQ 0.75MG BASE	Yes	No
007	BELBUCA	BUPRENORPHINE HYDROCHLORIDE	FILM;BUCCAL	EQ 0.9MG BASE	Yes	Yes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
55700-867	BELBUCA	buprenorphine hydrochloride	Quality Care Products, LLC	NDA	Current
55700-867	BELBUCA	buprenorphine hydrochloride	Quality Care Products, LLC	NDA	Current
59385-021	BELBUCA	buprenorphine hydrochloride	BioDelivery Sciences International Inc	NDA	Current
59385-021	BELBUCA	buprenorphine hydrochloride	BioDelivery Sciences International Inc	NDA	Current
59385-021	BELBUCA	buprenorphine hydrochloride	BioDelivery Sciences International Inc	NDA	Current
59385-021	BELBUCA	buprenorphine hydrochloride	BioDelivery Sciences International Inc	NDA	Current
59385-021	BELBUCA	buprenorphine hydrochloride	BioDelivery Sciences International Inc	NDA	Current
59385-021	BELBUCA	buprenorphine hydrochloride	BioDelivery Sciences International Inc	NDA	Current
59385-022	BELBUCA	buprenorphine hydrochloride	BioDelivery Sciences International Inc	NDA	Current
59385-022	BELBUCA	buprenorphine hydrochloride	BioDelivery Sciences International Inc	NDA	Current
59385-022	BELBUCA	buprenorphine hydrochloride	BioDelivery Sciences International Inc	NDA	Current
59385-022	BELBUCA	buprenorphine hydrochloride	BioDelivery Sciences International Inc	NDA	Current
59385-022	BELBUCA	buprenorphine hydrochloride	BioDelivery Sciences International Inc	NDA	Current
59385-022	BELBUCA	buprenorphine hydrochloride	BioDelivery Sciences International Inc	NDA	Current
59385-023	BELBUCA	buprenorphine hydrochloride	BioDelivery Sciences International Inc	NDA	Current
59385-023	BELBUCA	buprenorphine hydrochloride	BioDelivery Sciences International Inc	NDA	Current
59385-023	BELBUCA	buprenorphine hydrochloride	BioDelivery Sciences International Inc	NDA	Current
59385-023	BELBUCA	buprenorphine hydrochloride	BioDelivery Sciences International Inc	NDA	Current
59385-023	BELBUCA	buprenorphine hydrochloride	BioDelivery Sciences International Inc	NDA	Current
59385-023	BELBUCA	buprenorphine hydrochloride	BioDelivery Sciences International Inc	NDA	Current
59385-024	BELBUCA	buprenorphine hydrochloride	BioDelivery Sciences International Inc	NDA	Current
59385-024	BELBUCA	buprenorphine hydrochloride	BioDelivery Sciences International Inc	NDA	Current
59385-024	BELBUCA	buprenorphine hydrochloride	BioDelivery Sciences International Inc	NDA	Current
59385-024	BELBUCA	buprenorphine hydrochloride	BioDelivery Sciences International Inc	NDA	Current
59385-024	BELBUCA	buprenorphine hydrochloride	BioDelivery Sciences International Inc	NDA	Current
59385-024	BELBUCA	buprenorphine hydrochloride	BioDelivery Sciences International Inc	NDA	Current
59385-025	BELBUCA	buprenorphine hydrochloride	BioDelivery Sciences International Inc	NDA	Current
59385-025	BELBUCA	buprenorphine hydrochloride	BioDelivery Sciences International Inc	NDA	Current
59385-025	BELBUCA	buprenorphine hydrochloride	BioDelivery Sciences International Inc	NDA	Current
59385-025	BELBUCA	buprenorphine hydrochloride	BioDelivery Sciences International Inc	NDA	Current
59385-025	BELBUCA	buprenorphine hydrochloride	BioDelivery Sciences International Inc	NDA	Current
59385-025	BELBUCA	buprenorphine hydrochloride	BioDelivery Sciences International Inc	NDA	Current
59385-026	BELBUCA	buprenorphine hydrochloride	BioDelivery Sciences International Inc	NDA	Current
59385-026	BELBUCA	buprenorphine hydrochloride	BioDelivery Sciences International Inc	NDA	Current
59385-026	BELBUCA	buprenorphine hydrochloride	BioDelivery Sciences International Inc	NDA	Current
59385-026	BELBUCA	buprenorphine hydrochloride	BioDelivery Sciences International Inc	NDA	Current
59385-026	BELBUCA	buprenorphine hydrochloride	BioDelivery Sciences International Inc	NDA	Current
59385-026	BELBUCA	buprenorphine hydrochloride	BioDelivery Sciences International Inc	NDA	Current
59385-027	BELBUCA	buprenorphine hydrochloride	BioDelivery Sciences International Inc	NDA	Current
59385-027	BELBUCA	buprenorphine hydrochloride	BioDelivery Sciences International Inc	NDA	Current
59385-027	BELBUCA	buprenorphine hydrochloride	BioDelivery Sciences International Inc	NDA	Current
59385-027	BELBUCA	buprenorphine hydrochloride	BioDelivery Sciences International Inc	NDA	Current
59385-027	BELBUCA	buprenorphine hydrochloride	BioDelivery Sciences International Inc	NDA	Current
59385-027	BELBUCA	buprenorphine hydrochloride	BioDelivery Sciences International Inc	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84631	SUPPL	2026-01-05
84580	SUPPL	2025-12-29
80084	SUPPL	2024-11-04
77078	SUPPL	2023-12-19
77001	SUPPL	2023-12-19
76960	SUPPL	2023-12-18
71405	SUPPL	2022-06-21
71404	SUPPL	2022-06-21
71403	SUPPL	2022-06-21
71379	SUPPL	2022-06-21
71378	SUPPL	2022-06-21
66655	SUPPL	2021-03-08
66654	SUPPL	2021-03-08
66614	SUPPL	2021-03-08
60575	SUPPL	2019-10-17
60431	SUPPL	2019-10-09
60430	SUPPL	2019-10-09
60372	SUPPL	2019-10-08
57715	ORIG	2019-02-20
55696	SUPPL	2018-10-01
55537	SUPPL	2018-09-21
55536	SUPPL	2018-09-21
48589	SUPPL	2017-05-31
46582	SUPPL	2016-12-29
46446	SUPPL	2016-12-21
46314	SUPPL	2016-12-20
45451	SUPPL	2016-10-03
10633	SUPPL	2016-04-22
24131	ORIG	2015-10-28
40600	ORIG	2015-10-26
10632	ORIG	2015-10-26