Application 204242

Type: NDA
Sponsor: OREXO US INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZUBSOLV	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	TABLET;SUBLINGUAL	EQ 1.4MG BASE;EQ 0.36MG BASE	Yes	No
002	ZUBSOLV	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	TABLET;SUBLINGUAL	EQ 5.7MG BASE;EQ 1.4MG BASE	Yes	No
003	ZUBSOLV	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	TABLET;SUBLINGUAL	EQ 8.6MG BASE;EQ 2.1MG BASE	Yes	No
004	ZUBSOLV	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	TABLET;SUBLINGUAL	EQ 11.4MG BASE;EQ 2.9MG BASE	Yes	Yes
005	ZUBSOLV	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	TABLET;SUBLINGUAL	EQ 2.9MG BASE;EQ 0.71MG BASE	Yes	No
006	ZUBSOLV	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	TABLET;SUBLINGUAL	EQ 0.7MG BASE;EQ 0.18MG BASE	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N204242-001	ZUBSOLV	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	EQ 1.4MG BASE;EQ 0.36MG BASE	TABLET / SUBLINGUAL	RLD	2013-07-03
N204242-002	ZUBSOLV	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	EQ 5.7MG BASE;EQ 1.4MG BASE	TABLET / SUBLINGUAL	RLD	2013-07-03
N204242-003	ZUBSOLV	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	EQ 8.6MG BASE;EQ 2.1MG BASE	TABLET / SUBLINGUAL	RLD	2014-12-11
N204242-004	ZUBSOLV	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	EQ 11.4MG BASE;EQ 2.9MG BASE	TABLET / SUBLINGUAL	RLD, RS	2014-12-11
N204242-005	ZUBSOLV	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	EQ 2.9MG BASE;EQ 0.71MG BASE	TABLET / SUBLINGUAL	RLD	2015-06-04
N204242-006	ZUBSOLV	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	EQ 0.7MG BASE;EQ 0.18MG BASE	TABLET / SUBLINGUAL	RLD	2016-10-04

Orange Book patents#

Current patent rows page 1 of 1 · 51 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N204242-001	8658198	2027-12-03	U-1494	Drug product	2014-03-25
N204242-001	8470361	2030-05-22	U-1425	Drug product	2013-07-10
N204242-001	10946010	2032-09-18		Drug product	2021-03-30
N204242-001	11020388	2032-09-18	U-3131	Drug product	2021-06-21
N204242-001	11433066	2032-09-18	U-3131		2022-09-20
N204242-001	8940330	2032-09-18		Drug product	2015-02-05
N204242-001	9259421	2032-09-18		Drug product	2016-03-10
N204242-001	9439900	2032-09-18		Drug product	2016-10-03
N204242-002	8658198	2027-12-03	U-1494	Drug product	2014-03-25
N204242-002	8470361	2030-05-22	U-1425	Drug product	2013-07-10
N204242-002	10874661	2032-09-18		Drug product	2021-01-25
N204242-002	10946010	2032-09-18		Drug product	2021-03-30
N204242-002	11020387	2032-09-18	U-3131	Drug product	2021-06-21
N204242-002	11020388	2032-09-18	U-3131	Drug product	2021-06-21
N204242-002	11433066	2032-09-18	U-3131		2022-09-20
N204242-002	8940330	2032-09-18		Drug product	2015-02-05
N204242-002	9259421	2032-09-18		Drug product	2016-03-10
N204242-002	9439900	2032-09-18		Drug product	2016-10-03
N204242-003	8658198	2027-12-03	U-1494	Drug product
N204242-003	8470361	2030-05-22	U-1425	Drug product	2013-07-10
N204242-003	10946010	2032-09-18		Drug product	2021-03-30
N204242-003	11020387	2032-09-18	U-3131	Drug product	2021-06-21
N204242-003	11020388	2032-09-18	U-3131	Drug product	2021-06-21
N204242-003	11433066	2032-09-18	U-3131		2022-09-20
N204242-003	8940330	2032-09-18		Drug product	2015-02-05
N204242-003	9259421	2032-09-18		Drug product	2016-03-10
N204242-003	9439900	2032-09-18		Drug product	2016-10-03
N204242-004	8658198	2027-12-03	U-1494	Drug product	2015-01-09
N204242-004	8470361	2030-05-22	U-1425	Drug product	2013-07-10
N204242-004	10946010	2032-09-18		Drug product	2021-03-30
N204242-004	11020387	2032-09-18	U-3131	Drug product	2021-06-21
N204242-004	11020388	2032-09-18	U-3131	Drug product	2021-06-21
N204242-004	11433066	2032-09-18	U-3131		2022-09-20
N204242-004	8940330	2032-09-18		Drug product	2015-02-05
N204242-004	9259421	2032-09-18		Drug product	2016-03-10
N204242-004	9439900	2032-09-18		Drug product	2016-10-03
N204242-005	8658198	2027-12-03	U-1494	Drug product	2015-06-29
N204242-005	8470361	2030-05-22	U-1425	Drug product	2015-06-29
N204242-005	10946010	2032-09-18		Drug product	2021-03-30
N204242-005	11020387	2032-09-18	U-3131	Drug product	2021-06-21
N204242-005	11020388	2032-09-18	U-3131	Drug product	2021-06-21
N204242-005	11433066	2032-09-18	U-3131		2022-09-20
N204242-005	8940330	2032-09-18		Drug product	2015-06-29
N204242-005	9259421	2032-09-18		Drug product	2016-03-10
N204242-005	9439900	2032-09-18		Drug product	2016-10-03
N204242-006	8658198	2027-12-03	U-1494	Drug product	2016-10-26
N204242-006	8470361	2030-05-22	U-1425	Drug product	2016-10-26
N204242-006	10946010	2032-09-18		Drug product	2021-03-30
N204242-006	11020388	2032-09-18	U-3131	Drug product	2021-06-21
N204242-006	8940330	2032-09-18		Drug product	2016-10-26
N204242-006	9259421	2032-09-18		Drug product	2016-10-26

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 7 · 258 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N204242-001	ZUBSOLV	EQ 1.4MG BASE;EQ 0.36MG BASE	TABLET / SUBLINGUAL	RLD	2013-07-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204242-002	ZUBSOLV	EQ 5.7MG BASE;EQ 1.4MG BASE	TABLET / SUBLINGUAL	RLD	2013-07-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204242-003	ZUBSOLV	EQ 8.6MG BASE;EQ 2.1MG BASE	TABLET / SUBLINGUAL	RLD	2014-12-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204242-004	ZUBSOLV	EQ 11.4MG BASE;EQ 2.9MG BASE	TABLET / SUBLINGUAL	RLD, RS	2014-12-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204242-005	ZUBSOLV	EQ 2.9MG BASE;EQ 0.71MG BASE	TABLET / SUBLINGUAL	RLD	2015-06-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204242-006	ZUBSOLV	EQ 0.7MG BASE;EQ 0.18MG BASE	TABLET / SUBLINGUAL	RLD	2016-10-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N204242-001	ZUBSOLV	EQ 1.4MG BASE;EQ 0.36MG BASE	TABLET / SUBLINGUAL	RLD	2013-07-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204242-002	ZUBSOLV	EQ 5.7MG BASE;EQ 1.4MG BASE	TABLET / SUBLINGUAL	RLD	2013-07-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204242-003	ZUBSOLV	EQ 8.6MG BASE;EQ 2.1MG BASE	TABLET / SUBLINGUAL	RLD	2014-12-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204242-004	ZUBSOLV	EQ 11.4MG BASE;EQ 2.9MG BASE	TABLET / SUBLINGUAL	RLD, RS	2014-12-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204242-005	ZUBSOLV	EQ 2.9MG BASE;EQ 0.71MG BASE	TABLET / SUBLINGUAL	RLD	2015-06-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204242-006	ZUBSOLV	EQ 0.7MG BASE;EQ 0.18MG BASE	TABLET / SUBLINGUAL	RLD	2016-10-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N204242-001	ZUBSOLV	EQ 1.4MG BASE;EQ 0.36MG BASE	TABLET / SUBLINGUAL	RLD	2013-07-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204242-002	ZUBSOLV	EQ 5.7MG BASE;EQ 1.4MG BASE	TABLET / SUBLINGUAL	RLD	2013-07-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204242-003	ZUBSOLV	EQ 8.6MG BASE;EQ 2.1MG BASE	TABLET / SUBLINGUAL	RLD	2014-12-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204242-004	ZUBSOLV	EQ 11.4MG BASE;EQ 2.9MG BASE	TABLET / SUBLINGUAL	RLD, RS	2014-12-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204242-005	ZUBSOLV	EQ 2.9MG BASE;EQ 0.71MG BASE	TABLET / SUBLINGUAL	RLD	2015-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204242-006	ZUBSOLV	EQ 0.7MG BASE;EQ 0.18MG BASE	TABLET / SUBLINGUAL	RLD	2016-10-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204242-001	ZUBSOLV	EQ 1.4MG BASE;EQ 0.36MG BASE	TABLET / SUBLINGUAL	RLD	2013-07-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204242-002	ZUBSOLV	EQ 5.7MG BASE;EQ 1.4MG BASE	TABLET / SUBLINGUAL	RLD	2013-07-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204242-003	ZUBSOLV	EQ 8.6MG BASE;EQ 2.1MG BASE	TABLET / SUBLINGUAL	RLD	2014-12-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204242-004	ZUBSOLV	EQ 11.4MG BASE;EQ 2.9MG BASE	TABLET / SUBLINGUAL	RLD, RS	2014-12-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204242-005	ZUBSOLV	EQ 2.9MG BASE;EQ 0.71MG BASE	TABLET / SUBLINGUAL	RLD	2015-06-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204242-006	ZUBSOLV	EQ 0.7MG BASE;EQ 0.18MG BASE	TABLET / SUBLINGUAL	RLD	2016-10-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204242-001	ZUBSOLV	EQ 1.4MG BASE;EQ 0.36MG BASE	TABLET / SUBLINGUAL	RLD	2013-07-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204242-002	ZUBSOLV	EQ 5.7MG BASE;EQ 1.4MG BASE	TABLET / SUBLINGUAL	RLD	2013-07-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204242-003	ZUBSOLV	EQ 8.6MG BASE;EQ 2.1MG BASE	TABLET / SUBLINGUAL	RLD	2014-12-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204242-004	ZUBSOLV	EQ 11.4MG BASE;EQ 2.9MG BASE	TABLET / SUBLINGUAL	RLD, RS	2014-12-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204242-005	ZUBSOLV	EQ 2.9MG BASE;EQ 0.71MG BASE	TABLET / SUBLINGUAL	RLD	2015-06-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204242-006	ZUBSOLV	EQ 0.7MG BASE;EQ 0.18MG BASE	TABLET / SUBLINGUAL	RLD	2016-10-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204242-001	ZUBSOLV	EQ 1.4MG BASE;EQ 0.36MG BASE	TABLET / SUBLINGUAL	RLD	2013-07-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204242-002	ZUBSOLV	EQ 5.7MG BASE;EQ 1.4MG BASE	TABLET / SUBLINGUAL	RLD	2013-07-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204242-003	ZUBSOLV	EQ 8.6MG BASE;EQ 2.1MG BASE	TABLET / SUBLINGUAL	RLD	2014-12-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204242-004	ZUBSOLV	EQ 11.4MG BASE;EQ 2.9MG BASE	TABLET / SUBLINGUAL	RLD, RS	2014-12-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204242-005	ZUBSOLV	EQ 2.9MG BASE;EQ 0.71MG BASE	TABLET / SUBLINGUAL	RLD	2015-06-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204242-006	ZUBSOLV	EQ 0.7MG BASE;EQ 0.18MG BASE	TABLET / SUBLINGUAL	RLD	2016-10-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204242-001	ZUBSOLV	EQ 1.4MG BASE;EQ 0.36MG BASE	TABLET / SUBLINGUAL	RLD	2013-07-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204242-002	ZUBSOLV	EQ 5.7MG BASE;EQ 1.4MG BASE	TABLET / SUBLINGUAL	RLD	2013-07-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204242-003	ZUBSOLV	EQ 8.6MG BASE;EQ 2.1MG BASE	TABLET / SUBLINGUAL	RLD	2014-12-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204242-004	ZUBSOLV	EQ 11.4MG BASE;EQ 2.9MG BASE	TABLET / SUBLINGUAL	RLD, RS	2014-12-11	`b8a1b40f171c…`

Observed Orange Book patent history#

Patent history page 1 of 52 · 2,052 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N204242-001	8658198	2027-12-03	U-1494	Drug product	2014-03-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204242-001	8470361	2030-05-22	U-1425	Drug product	2013-07-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204242-001	10946010	2032-09-18		Drug product	2021-03-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204242-001	11020388	2032-09-18	U-3131	Drug product	2021-06-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204242-001	11433066	2032-09-18	U-3131		2022-09-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204242-001	8940330	2032-09-18		Drug product	2015-02-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204242-001	9259421	2032-09-18		Drug product	2016-03-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204242-001	9439900	2032-09-18		Drug product	2016-10-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204242-002	8658198	2027-12-03	U-1494	Drug product	2014-03-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204242-002	8470361	2030-05-22	U-1425	Drug product	2013-07-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204242-002	10874661	2032-09-18		Drug product	2021-01-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204242-002	10946010	2032-09-18		Drug product	2021-03-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204242-002	11020387	2032-09-18	U-3131	Drug product	2021-06-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204242-002	11020388	2032-09-18	U-3131	Drug product	2021-06-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204242-002	11433066	2032-09-18	U-3131		2022-09-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204242-002	8940330	2032-09-18		Drug product	2015-02-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204242-002	9259421	2032-09-18		Drug product	2016-03-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204242-002	9439900	2032-09-18		Drug product	2016-10-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204242-003	8658198	2027-12-03	U-1494	Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204242-003	8470361	2030-05-22	U-1425	Drug product	2013-07-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204242-003	10946010	2032-09-18		Drug product	2021-03-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204242-003	11020387	2032-09-18	U-3131	Drug product	2021-06-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204242-003	11020388	2032-09-18	U-3131	Drug product	2021-06-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204242-003	11433066	2032-09-18	U-3131		2022-09-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204242-003	8940330	2032-09-18		Drug product	2015-02-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204242-003	9259421	2032-09-18		Drug product	2016-03-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204242-003	9439900	2032-09-18		Drug product	2016-10-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204242-004	8658198	2027-12-03	U-1494	Drug product	2015-01-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204242-004	8470361	2030-05-22	U-1425	Drug product	2013-07-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204242-004	10946010	2032-09-18		Drug product	2021-03-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204242-004	11020387	2032-09-18	U-3131	Drug product	2021-06-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204242-004	11020388	2032-09-18	U-3131	Drug product	2021-06-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204242-004	11433066	2032-09-18	U-3131		2022-09-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204242-004	8940330	2032-09-18		Drug product	2015-02-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204242-004	9259421	2032-09-18		Drug product	2016-03-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204242-004	9439900	2032-09-18		Drug product	2016-10-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204242-005	8658198	2027-12-03	U-1494	Drug product	2015-06-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204242-005	8470361	2030-05-22	U-1425	Drug product	2015-06-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204242-005	10946010	2032-09-18		Drug product	2021-03-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204242-005	11020387	2032-09-18	U-3131	Drug product	2021-06-21	`84e616aacf4f…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zubsolv	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	Edenbridge Pharmaceuticals LLC.	57583c1d-9c44-4503-917d-68dba7377bd1	2026-06-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 204242 application number: NDA204242
Zubsolv	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	Orexo US, Inc.	5f5cfcfe-d52b-49e6-8fe4-550477332dd2	2025-12-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 204242 application number: NDA204242 ndc (product): 54123-907 ndc (product): 54123-986 ndc (product): 54123-914 ndc (product): 54123-929 ndc (product): 54123-114 ndc (product): 54123-957

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 30 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
54123-114	Zubsolv	buprenorphine hydrochloride and naloxone hydrochloride	Orexo US, Inc.	NDA	Current
54123-114	Zubsolv	buprenorphine hydrochloride and naloxone hydrochloride	Orexo US, Inc.	NDA	Current
54123-114	Zubsolv	buprenorphine hydrochloride and naloxone hydrochloride	Orexo US, Inc.	NDA	Current
54123-114	Zubsolv	buprenorphine hydrochloride and naloxone hydrochloride	Orexo US, Inc.	NDA	Current
54123-114	Zubsolv	buprenorphine hydrochloride and naloxone hydrochloride	Orexo US, Inc.	NDA	Current
54123-907	Zubsolv	buprenorphine hydrochloride and naloxone hydrochloride	Orexo US, Inc.	NDA	Current
54123-907	Zubsolv	buprenorphine hydrochloride and naloxone hydrochloride	Orexo US, Inc.	NDA	Current
54123-907	Zubsolv	buprenorphine hydrochloride and naloxone hydrochloride	Orexo US, Inc.	NDA	Current
54123-907	Zubsolv	buprenorphine hydrochloride and naloxone hydrochloride	Orexo US, Inc.	NDA	Current
54123-907	Zubsolv	buprenorphine hydrochloride and naloxone hydrochloride	Orexo US, Inc.	NDA	Current
54123-914	Zubsolv	buprenorphine hydrochloride and naloxone hydrochloride	Orexo US, Inc.	NDA	Current
54123-914	Zubsolv	buprenorphine hydrochloride and naloxone hydrochloride	Orexo US, Inc.	NDA	Current
54123-914	Zubsolv	buprenorphine hydrochloride and naloxone hydrochloride	Orexo US, Inc.	NDA	Current
54123-914	Zubsolv	buprenorphine hydrochloride and naloxone hydrochloride	Orexo US, Inc.	NDA	Current
54123-914	Zubsolv	buprenorphine hydrochloride and naloxone hydrochloride	Orexo US, Inc.	NDA	Current
54123-929	Zubsolv	buprenorphine hydrochloride and naloxone hydrochloride	Orexo US, Inc.	NDA	Current
54123-929	Zubsolv	buprenorphine hydrochloride and naloxone hydrochloride	Orexo US, Inc.	NDA	Current
54123-929	Zubsolv	buprenorphine hydrochloride and naloxone hydrochloride	Orexo US, Inc.	NDA	Current
54123-929	Zubsolv	buprenorphine hydrochloride and naloxone hydrochloride	Orexo US, Inc.	NDA	Current
54123-929	Zubsolv	buprenorphine hydrochloride and naloxone hydrochloride	Orexo US, Inc.	NDA	Current
54123-957	Zubsolv	buprenorphine hydrochloride and naloxone hydrochloride	Orexo US, Inc.	NDA	Current
54123-957	Zubsolv	buprenorphine hydrochloride and naloxone hydrochloride	Orexo US, Inc.	NDA	Current
54123-957	Zubsolv	buprenorphine hydrochloride and naloxone hydrochloride	Orexo US, Inc.	NDA	Current
54123-957	Zubsolv	buprenorphine hydrochloride and naloxone hydrochloride	Orexo US, Inc.	NDA	Current
54123-957	Zubsolv	buprenorphine hydrochloride and naloxone hydrochloride	Orexo US, Inc.	NDA	Current
54123-986	Zubsolv	buprenorphine hydrochloride and naloxone hydrochloride	Orexo US, Inc.	NDA	Current
54123-986	Zubsolv	buprenorphine hydrochloride and naloxone hydrochloride	Orexo US, Inc.	NDA	Current
54123-986	Zubsolv	buprenorphine hydrochloride and naloxone hydrochloride	Orexo US, Inc.	NDA	Current
54123-986	Zubsolv	buprenorphine hydrochloride and naloxone hydrochloride	Orexo US, Inc.	NDA	Current
54123-986	Zubsolv	buprenorphine hydrochloride and naloxone hydrochloride	Orexo US, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84658	SUPPL	2026-01-06
84577	SUPPL	2025-12-29
82212	SUPPL	2025-05-21
82237	SUPPL	2025-05-19
81361	SUPPL	2025-02-25
77895	SUPPL	2024-03-21
77075	SUPPL	2023-12-19
76967	SUPPL	2023-12-18
76966	SUPPL	2023-12-18
73854	SUPPL	2023-03-24
73839	SUPPL	2023-03-24
73065	SUPPL	2022-12-29
71397	SUPPL	2022-06-21
71396	SUPPL	2022-06-21
71395	SUPPL	2022-06-21
71374	SUPPL	2022-06-21
71373	SUPPL	2022-06-21
70974	SUPPL	2022-05-04
66645	SUPPL	2021-03-08
66644	SUPPL	2021-03-08
66610	SUPPL	2021-03-08
60478	SUPPL	2019-10-09
60477	SUPPL	2019-10-09
60460	SUPPL	2019-10-09
56297	SUPPL	2018-11-06
52289	SUPPL	2018-02-02
52244	SUPPL	2018-02-01
49709	SUPPL	2017-09-11
49708	SUPPL	2017-09-11
48521	SUPPL	2017-05-25
46436	SUPPL	2016-12-21
46433	SUPPL	2016-12-21
45598	SUPPL	2016-10-07
45505	SUPPL	2016-10-06
32530	SUPPL	2016-07-12
40367	SUPPL	2015-08-11
32527	SUPPL	2015-08-11
32529	SUPPL	2015-06-10
19536	SUPPL	2015-06-10
32528	SUPPL	2015-02-17
19535	SUPPL	2015-02-03
10312	SUPPL	2014-12-12
43459	ORIG	2014-06-27
32526	SUPPL	2013-09-09
44591	ORIG	2013-07-23
10311	ORIG	2013-07-08
40366	ORIG	2013-07-05