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

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

Orange Book products#

Current product rows page 1 of 1 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N207932-001	BELBUCA	BUPRENORPHINE HYDROCHLORIDE	EQ 0.075MG BASE	FILM / BUCCAL	RLD	2015-10-23
N207932-002	BELBUCA	BUPRENORPHINE HYDROCHLORIDE	EQ 0.15MG BASE	FILM / BUCCAL	RLD	2015-10-23
N207932-003	BELBUCA	BUPRENORPHINE HYDROCHLORIDE	EQ 0.3MG BASE	FILM / BUCCAL	RLD	2015-10-23
N207932-004	BELBUCA	BUPRENORPHINE HYDROCHLORIDE	EQ 0.45MG BASE	FILM / BUCCAL	RLD	2015-10-23
N207932-005	BELBUCA	BUPRENORPHINE HYDROCHLORIDE	EQ 0.6MG BASE	FILM / BUCCAL	RLD	2015-10-23
N207932-006	BELBUCA	BUPRENORPHINE HYDROCHLORIDE	EQ 0.75MG BASE	FILM / BUCCAL	RLD	2015-10-23
N207932-007	BELBUCA	BUPRENORPHINE HYDROCHLORIDE	EQ 0.9MG BASE	FILM / BUCCAL	RLD, RS	2015-10-23

Orange Book patents#

Current patent rows page 1 of 1 · 21 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N207932-001	8147866	2027-07-23	U-1769	Drug product	2015-11-20
N207932-001	9655843	2027-07-23	U-1556	Drug product	2017-06-13
N207932-001	9901539	2032-12-21	U-1556		2018-03-28
N207932-002	8147866	2027-07-23	U-1769	Drug product	2015-11-20
N207932-002	9655843	2027-07-23	U-1556	Drug product	2017-06-13
N207932-002	9901539	2032-12-21	U-1556		2018-03-28
N207932-003	8147866	2027-07-23	U-1769	Drug product	2015-11-20
N207932-003	9655843	2027-07-23	U-1556	Drug product	2017-06-13
N207932-003	9901539	2032-12-21	U-1556		2018-03-28
N207932-004	8147866	2027-07-23	U-1769	Drug product	2015-11-20
N207932-004	9655843	2027-07-23	U-1556	Drug product	2017-06-13
N207932-004	9901539	2032-12-21	U-1556		2018-03-28
N207932-005	8147866	2027-07-23	U-1769	Drug product	2015-11-20
N207932-005	9655843	2027-07-23	U-1556	Drug product	2017-06-13
N207932-005	9901539	2032-12-21	U-1556		2018-03-28
N207932-006	8147866	2027-07-23	U-1769	Drug product	2015-11-20
N207932-006	9655843	2027-07-23	U-1556	Drug product	2017-06-13
N207932-006	9901539	2032-12-21	U-1556		2018-03-28
N207932-007	8147866	2027-07-23	U-1769	Drug product	2015-11-20
N207932-007	9655843	2027-07-23	U-1556	Drug product	2017-06-13
N207932-007	9901539	2032-12-21	U-1556		2018-03-28

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 8 · 287 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	N207932-001	BELBUCA	EQ 0.075MG BASE	FILM / BUCCAL	RLD	2015-10-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207932-002	BELBUCA	EQ 0.15MG BASE	FILM / BUCCAL	RLD	2015-10-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207932-003	BELBUCA	EQ 0.3MG BASE	FILM / BUCCAL	RLD	2015-10-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207932-004	BELBUCA	EQ 0.45MG BASE	FILM / BUCCAL	RLD	2015-10-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207932-005	BELBUCA	EQ 0.6MG BASE	FILM / BUCCAL	RLD	2015-10-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207932-006	BELBUCA	EQ 0.75MG BASE	FILM / BUCCAL	RLD	2015-10-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207932-007	BELBUCA	EQ 0.9MG BASE	FILM / BUCCAL	RLD, RS	2015-10-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207932-001	BELBUCA	EQ 0.075MG BASE	FILM / BUCCAL	RLD	2015-10-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207932-002	BELBUCA	EQ 0.15MG BASE	FILM / BUCCAL	RLD	2015-10-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207932-003	BELBUCA	EQ 0.3MG BASE	FILM / BUCCAL	RLD	2015-10-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207932-004	BELBUCA	EQ 0.45MG BASE	FILM / BUCCAL	RLD	2015-10-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207932-005	BELBUCA	EQ 0.6MG BASE	FILM / BUCCAL	RLD	2015-10-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207932-006	BELBUCA	EQ 0.75MG BASE	FILM / BUCCAL	RLD	2015-10-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207932-007	BELBUCA	EQ 0.9MG BASE	FILM / BUCCAL	RLD, RS	2015-10-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N207932-001	BELBUCA	EQ 0.075MG BASE	FILM / BUCCAL	RLD	2015-10-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207932-002	BELBUCA	EQ 0.15MG BASE	FILM / BUCCAL	RLD	2015-10-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207932-003	BELBUCA	EQ 0.3MG BASE	FILM / BUCCAL	RLD	2015-10-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207932-004	BELBUCA	EQ 0.45MG BASE	FILM / BUCCAL	RLD	2015-10-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207932-005	BELBUCA	EQ 0.6MG BASE	FILM / BUCCAL	RLD	2015-10-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207932-006	BELBUCA	EQ 0.75MG BASE	FILM / BUCCAL	RLD	2015-10-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207932-007	BELBUCA	EQ 0.9MG BASE	FILM / BUCCAL	RLD, RS	2015-10-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207932-001	BELBUCA	EQ 0.075MG BASE	FILM / BUCCAL	RLD	2015-10-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207932-002	BELBUCA	EQ 0.15MG BASE	FILM / BUCCAL	RLD	2015-10-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207932-003	BELBUCA	EQ 0.3MG BASE	FILM / BUCCAL	RLD	2015-10-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207932-004	BELBUCA	EQ 0.45MG BASE	FILM / BUCCAL	RLD	2015-10-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207932-005	BELBUCA	EQ 0.6MG BASE	FILM / BUCCAL	RLD	2015-10-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207932-006	BELBUCA	EQ 0.75MG BASE	FILM / BUCCAL	RLD	2015-10-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207932-007	BELBUCA	EQ 0.9MG BASE	FILM / BUCCAL	RLD, RS	2015-10-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207932-001	BELBUCA	EQ 0.075MG BASE	FILM / BUCCAL	RLD	2015-10-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207932-002	BELBUCA	EQ 0.15MG BASE	FILM / BUCCAL	RLD	2015-10-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207932-003	BELBUCA	EQ 0.3MG BASE	FILM / BUCCAL	RLD	2015-10-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207932-004	BELBUCA	EQ 0.45MG BASE	FILM / BUCCAL	RLD	2015-10-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207932-005	BELBUCA	EQ 0.6MG BASE	FILM / BUCCAL	RLD	2015-10-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207932-006	BELBUCA	EQ 0.75MG BASE	FILM / BUCCAL	RLD	2015-10-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207932-007	BELBUCA	EQ 0.9MG BASE	FILM / BUCCAL	RLD, RS	2015-10-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207932-001	BELBUCA	EQ 0.075MG BASE	FILM / BUCCAL	RLD	2015-10-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207932-002	BELBUCA	EQ 0.15MG BASE	FILM / BUCCAL	RLD	2015-10-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207932-003	BELBUCA	EQ 0.3MG BASE	FILM / BUCCAL	RLD	2015-10-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207932-004	BELBUCA	EQ 0.45MG BASE	FILM / BUCCAL	RLD	2015-10-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207932-005	BELBUCA	EQ 0.6MG BASE	FILM / BUCCAL	RLD	2015-10-23	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2021-12-28 21:50 UTC	2021-12	N207932-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N207932-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N207932-003	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N207932-004	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N207932-005	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N207932-006	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N207932-007	AB	1	`782e0a99824c…`

Observed Orange Book patent history#

Patent history page 1 of 23 · 903 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	N207932-001	8147866	2027-07-23	U-1769	Drug product	2015-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207932-001	9655843	2027-07-23	U-1556	Drug product	2017-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207932-001	9901539	2032-12-21	U-1556		2018-03-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207932-002	8147866	2027-07-23	U-1769	Drug product	2015-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207932-002	9655843	2027-07-23	U-1556	Drug product	2017-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207932-002	9901539	2032-12-21	U-1556		2018-03-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207932-003	8147866	2027-07-23	U-1769	Drug product	2015-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207932-003	9655843	2027-07-23	U-1556	Drug product	2017-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207932-003	9901539	2032-12-21	U-1556		2018-03-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207932-004	8147866	2027-07-23	U-1769	Drug product	2015-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207932-004	9655843	2027-07-23	U-1556	Drug product	2017-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207932-004	9901539	2032-12-21	U-1556		2018-03-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207932-005	8147866	2027-07-23	U-1769	Drug product	2015-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207932-005	9655843	2027-07-23	U-1556	Drug product	2017-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207932-005	9901539	2032-12-21	U-1556		2018-03-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207932-006	8147866	2027-07-23	U-1769	Drug product	2015-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207932-006	9655843	2027-07-23	U-1556	Drug product	2017-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207932-006	9901539	2032-12-21	U-1556		2018-03-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207932-007	8147866	2027-07-23	U-1769	Drug product	2015-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207932-007	9655843	2027-07-23	U-1556	Drug product	2017-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207932-007	9901539	2032-12-21	U-1556		2018-03-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207932-001	8147866	2027-07-23	U-1769	Drug product	2015-11-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207932-001	9655843	2027-07-23	U-1556	Drug product	2017-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207932-001	9901539	2032-12-21	U-1556		2018-03-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207932-002	8147866	2027-07-23	U-1769	Drug product	2015-11-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207932-002	9655843	2027-07-23	U-1556	Drug product	2017-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207932-002	9901539	2032-12-21	U-1556		2018-03-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207932-003	8147866	2027-07-23	U-1769	Drug product	2015-11-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207932-003	9655843	2027-07-23	U-1556	Drug product	2017-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207932-003	9901539	2032-12-21	U-1556		2018-03-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207932-004	8147866	2027-07-23	U-1769	Drug product	2015-11-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207932-004	9655843	2027-07-23	U-1556	Drug product	2017-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207932-004	9901539	2032-12-21	U-1556		2018-03-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207932-005	8147866	2027-07-23	U-1769	Drug product	2015-11-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207932-005	9655843	2027-07-23	U-1556	Drug product	2017-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207932-005	9901539	2032-12-21	U-1556		2018-03-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207932-006	8147866	2027-07-23	U-1769	Drug product	2015-11-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207932-006	9655843	2027-07-23	U-1556	Drug product	2017-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207932-006	9901539	2032-12-21	U-1556		2018-03-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207932-007	8147866	2027-07-23	U-1769	Drug product	2015-11-20	`31067a03dcf5…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BELBUCA	BUPRENORPHINE HYDROCHLORIDE	BioDelivery Sciences International Inc	bc2b7a3d-72cf-497c-95b0-ba2b71f63c64	2026-01-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 207932 application number: NDA207932 ndc (product): 59385-025 ndc (product): 59385-026 ndc (product): 59385-022 ndc (product): 59385-024 ndc (product): 59385-023 ndc (product): 59385-021 ndc (product): 59385-027

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 44 matching rows.

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