Application 205637

Type: NDA
Sponsor: BDSI

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BUNAVAIL	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	FILM;BUCCAL	EQ 2.1MG BASE;EQ 0.3MG BASE	Yes	No
002	BUNAVAIL	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	FILM;BUCCAL	EQ 4.2MG BASE;EQ 0.7MG BASE	Yes	No
003	BUNAVAIL	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	FILM;BUCCAL	EQ 6.3MG BASE;EQ 1MG BASE	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N205637-001	BUNAVAIL	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	EQ 2.1MG BASE;EQ 0.3MG BASE	FILM / BUCCAL	RLD	2014-06-06
N205637-002	BUNAVAIL	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	EQ 4.2MG BASE;EQ 0.7MG BASE	FILM / BUCCAL	RLD	2014-06-06
N205637-003	BUNAVAIL	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	EQ 6.3MG BASE;EQ 1MG BASE	FILM / BUCCAL	RLD	2014-06-06

Orange Book patents#

Current patent rows page 1 of 1 · 12 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N205637-001	8147866	2027-07-23	U-1521	Drug product	2014-06-20
N205637-001	9655843	2027-07-23	U-2017	Drug product	2017-06-13
N205637-001	8703177	2032-08-20		Drug product	2014-06-20
N205637-001	9522188	2035-04-24		Drug product	2016-12-20
N205637-002	8147866	2027-07-23	U-1521	Drug product	2014-06-20
N205637-002	9655843	2027-07-23	U-2017	Drug product	2017-06-13
N205637-002	8703177	2032-08-20		Drug product	2014-06-20
N205637-002	9522188	2035-04-24		Drug product	2016-12-20
N205637-003	8147866	2027-07-23	U-1521	Drug product	2014-06-20
N205637-003	9655843	2027-07-23	U-2017	Drug product	2017-06-13
N205637-003	8703177	2032-08-20		Drug product	2014-06-20
N205637-003	9522188	2035-04-24		Drug product	2016-12-20

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N205637-001	BUNAVAIL	EQ 2.1MG BASE;EQ 0.3MG BASE	FILM / BUCCAL	RLD	2014-06-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205637-002	BUNAVAIL	EQ 4.2MG BASE;EQ 0.7MG BASE	FILM / BUCCAL	RLD	2014-06-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205637-003	BUNAVAIL	EQ 6.3MG BASE;EQ 1MG BASE	FILM / BUCCAL	RLD	2014-06-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205637-001	BUNAVAIL	EQ 2.1MG BASE;EQ 0.3MG BASE	FILM / BUCCAL	RLD	2014-06-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205637-002	BUNAVAIL	EQ 4.2MG BASE;EQ 0.7MG BASE	FILM / BUCCAL	RLD	2014-06-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205637-003	BUNAVAIL	EQ 6.3MG BASE;EQ 1MG BASE	FILM / BUCCAL	RLD	2014-06-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205637-001	BUNAVAIL	EQ 2.1MG BASE;EQ 0.3MG BASE	FILM / BUCCAL	RLD	2014-06-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205637-002	BUNAVAIL	EQ 4.2MG BASE;EQ 0.7MG BASE	FILM / BUCCAL	RLD	2014-06-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205637-003	BUNAVAIL	EQ 6.3MG BASE;EQ 1MG BASE	FILM / BUCCAL	RLD	2014-06-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205637-001	BUNAVAIL	EQ 2.1MG BASE;EQ 0.3MG BASE	FILM / BUCCAL	RLD	2014-06-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205637-002	BUNAVAIL	EQ 4.2MG BASE;EQ 0.7MG BASE	FILM / BUCCAL	RLD	2014-06-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205637-003	BUNAVAIL	EQ 6.3MG BASE;EQ 1MG BASE	FILM / BUCCAL	RLD	2014-06-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205637-001	BUNAVAIL	EQ 2.1MG BASE;EQ 0.3MG BASE	FILM / BUCCAL	RLD	2014-06-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205637-002	BUNAVAIL	EQ 4.2MG BASE;EQ 0.7MG BASE	FILM / BUCCAL	RLD	2014-06-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205637-003	BUNAVAIL	EQ 6.3MG BASE;EQ 1MG BASE	FILM / BUCCAL	RLD	2014-06-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205637-001	BUNAVAIL	EQ 2.1MG BASE;EQ 0.3MG BASE	FILM / BUCCAL	RLD	2014-06-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205637-002	BUNAVAIL	EQ 4.2MG BASE;EQ 0.7MG BASE	FILM / BUCCAL	RLD	2014-06-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205637-003	BUNAVAIL	EQ 6.3MG BASE;EQ 1MG BASE	FILM / BUCCAL	RLD	2014-06-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205637-001	BUNAVAIL	EQ 2.1MG BASE;EQ 0.3MG BASE	FILM / BUCCAL	RLD	2014-06-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205637-002	BUNAVAIL	EQ 4.2MG BASE;EQ 0.7MG BASE	FILM / BUCCAL	RLD	2014-06-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205637-003	BUNAVAIL	EQ 6.3MG BASE;EQ 1MG BASE	FILM / BUCCAL	RLD	2014-06-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205637-001	BUNAVAIL	EQ 2.1MG BASE;EQ 0.3MG BASE	FILM / BUCCAL	RLD	2014-06-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205637-002	BUNAVAIL	EQ 4.2MG BASE;EQ 0.7MG BASE	FILM / BUCCAL	RLD	2014-06-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205637-003	BUNAVAIL	EQ 6.3MG BASE;EQ 1MG BASE	FILM / BUCCAL	RLD	2014-06-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205637-001	BUNAVAIL	EQ 2.1MG BASE;EQ 0.3MG BASE	FILM / BUCCAL	RLD	2014-06-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205637-002	BUNAVAIL	EQ 4.2MG BASE;EQ 0.7MG BASE	FILM / BUCCAL	RLD	2014-06-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205637-003	BUNAVAIL	EQ 6.3MG BASE;EQ 1MG BASE	FILM / BUCCAL	RLD	2014-06-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205637-001	BUNAVAIL	EQ 2.1MG BASE;EQ 0.3MG BASE	FILM / BUCCAL	RLD	2014-06-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N205637-002	BUNAVAIL	EQ 4.2MG BASE;EQ 0.7MG BASE	FILM / BUCCAL	RLD	2014-06-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N205637-003	BUNAVAIL	EQ 6.3MG BASE;EQ 1MG BASE	FILM / BUCCAL	RLD	2014-06-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205637-001	BUNAVAIL	EQ 2.1MG BASE;EQ 0.3MG BASE	FILM / BUCCAL	RLD	2014-06-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205637-002	BUNAVAIL	EQ 4.2MG BASE;EQ 0.7MG BASE	FILM / BUCCAL	RLD	2014-06-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205637-003	BUNAVAIL	EQ 6.3MG BASE;EQ 1MG BASE	FILM / BUCCAL	RLD	2014-06-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205637-001	BUNAVAIL	EQ 2.1MG BASE;EQ 0.3MG BASE	FILM / BUCCAL	RLD	2014-06-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205637-002	BUNAVAIL	EQ 4.2MG BASE;EQ 0.7MG BASE	FILM / BUCCAL	RLD	2014-06-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205637-003	BUNAVAIL	EQ 6.3MG BASE;EQ 1MG BASE	FILM / BUCCAL	RLD	2014-06-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205637-001	BUNAVAIL	EQ 2.1MG BASE;EQ 0.3MG BASE	FILM / BUCCAL	RLD	2014-06-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205637-002	BUNAVAIL	EQ 4.2MG BASE;EQ 0.7MG BASE	FILM / BUCCAL	RLD	2014-06-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205637-003	BUNAVAIL	EQ 6.3MG BASE;EQ 1MG BASE	FILM / BUCCAL	RLD	2014-06-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N205637-001	BUNAVAIL	EQ 2.1MG BASE;EQ 0.3MG BASE	FILM / BUCCAL	RLD	2014-06-06	`8072bd15b7f6…`

Observed Orange Book patent history#

Patent history page 1 of 13 · 510 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N205637-001	8147866	2027-07-23	U-1521	Drug product	2014-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205637-001	9655843	2027-07-23	U-2017	Drug product	2017-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205637-001	8703177	2032-08-20		Drug product	2014-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205637-001	9522188	2035-04-24		Drug product	2016-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205637-002	8147866	2027-07-23	U-1521	Drug product	2014-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205637-002	9655843	2027-07-23	U-2017	Drug product	2017-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205637-002	8703177	2032-08-20		Drug product	2014-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205637-002	9522188	2035-04-24		Drug product	2016-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205637-003	8147866	2027-07-23	U-1521	Drug product	2014-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205637-003	9655843	2027-07-23	U-2017	Drug product	2017-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205637-003	8703177	2032-08-20		Drug product	2014-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205637-003	9522188	2035-04-24		Drug product	2016-12-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205637-001	8147866	2027-07-23	U-1521	Drug product	2014-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205637-001	9655843	2027-07-23	U-2017	Drug product	2017-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205637-001	8703177	2032-08-20		Drug product	2014-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205637-001	9522188	2035-04-24		Drug product	2016-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205637-002	8147866	2027-07-23	U-1521	Drug product	2014-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205637-002	9655843	2027-07-23	U-2017	Drug product	2017-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205637-002	8703177	2032-08-20		Drug product	2014-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205637-002	9522188	2035-04-24		Drug product	2016-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205637-003	8147866	2027-07-23	U-1521	Drug product	2014-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205637-003	9655843	2027-07-23	U-2017	Drug product	2017-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205637-003	8703177	2032-08-20		Drug product	2014-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205637-003	9522188	2035-04-24		Drug product	2016-12-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205637-001	8147866	2027-07-23	U-1521	Drug product	2014-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205637-001	9655843	2027-07-23	U-2017	Drug product	2017-06-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205637-001	8703177	2032-08-20		Drug product	2014-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205637-001	9522188	2035-04-24		Drug product	2016-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205637-002	8147866	2027-07-23	U-1521	Drug product	2014-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205637-002	9655843	2027-07-23	U-2017	Drug product	2017-06-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205637-002	8703177	2032-08-20		Drug product	2014-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205637-002	9522188	2035-04-24		Drug product	2016-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205637-003	8147866	2027-07-23	U-1521	Drug product	2014-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205637-003	9655843	2027-07-23	U-2017	Drug product	2017-06-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205637-003	8703177	2032-08-20		Drug product	2014-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205637-003	9522188	2035-04-24		Drug product	2016-12-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205637-001	8147866	2027-07-23	U-1521	Drug product	2014-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205637-001	9655843	2027-07-23	U-2017	Drug product	2017-06-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205637-001	8703177	2032-08-20		Drug product	2014-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205637-001	9522188	2035-04-24		Drug product	2016-12-20	`fd3edfee7708…`

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
59385-012	BUNAVAIL	buprenorphine and naloxone	BioDelivery Sciences International, Inc.	NDA	Current
59385-012	BUNAVAIL	buprenorphine and naloxone	BioDelivery Sciences International, Inc.	NDA	Current
59385-012	BUNAVAIL	buprenorphine and naloxone	BioDelivery Sciences International, Inc.	NDA	Current
59385-014	BUNAVAIL	buprenorphine and naloxone	BioDelivery Sciences International, Inc.	NDA	Current
59385-014	BUNAVAIL	buprenorphine and naloxone	BioDelivery Sciences International, Inc.	NDA	Current
59385-014	BUNAVAIL	buprenorphine and naloxone	BioDelivery Sciences International, Inc.	NDA	Current
59385-014	BUNAVAIL	buprenorphine and naloxone	BioDelivery Sciences International, Inc.	NDA	Current
59385-016	BUNAVAIL	buprenorphine and naloxone	BioDelivery Sciences International, Inc.	NDA	Current
59385-016	BUNAVAIL	buprenorphine and naloxone	BioDelivery Sciences International, Inc.	NDA	Current
59385-016	BUNAVAIL	buprenorphine and naloxone	BioDelivery Sciences International, Inc.	NDA	Current
59385-016	BUNAVAIL	buprenorphine and naloxone	BioDelivery Sciences International, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
73063	SUPPL	2022-12-29
71400	SUPPL	2022-06-21
71398	SUPPL	2022-06-21
71377	SUPPL	2022-06-21
71376	SUPPL	2022-06-21
70975	SUPPL	2022-05-04
66651	SUPPL	2021-03-08
66650	SUPPL	2021-03-08
66612	SUPPL	2021-03-08
60484	SUPPL	2019-10-09
60483	SUPPL	2019-10-09
60462	SUPPL	2019-10-09
56298	SUPPL	2018-11-06
52291	SUPPL	2018-02-02
52241	SUPPL	2018-02-01
48522	SUPPL	2017-05-25
48184	SUPPL	2017-05-02
48183	SUPPL	2017-05-02
48167	SUPPL	2017-04-28
48166	SUPPL	2017-04-28
46435	SUPPL	2016-12-21
46325	SUPPL	2016-12-20
32697	SUPPL	2016-07-11
24499	ORIG	2015-05-28
22998	ORIG	2015-05-28
10483	SUPPL	2015-02-17
44597	ORIG	2015-01-08
19670	ORIG	2014-06-10
10482	ORIG	2014-06-10