Application 020732

Type: NDA
Sponsor: INDIVIOR INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	SUBUTEX	BUPRENORPHINE HYDROCHLORIDE	TABLET;SUBLINGUAL	EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
003	SUBUTEX	BUPRENORPHINE HYDROCHLORIDE	TABLET;SUBLINGUAL	EQ 8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020732-002	SUBUTEX	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL		RLD	2002-10-08
N020732-003	SUBUTEX	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL		RLD	2002-10-08

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 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N020732-002	SUBUTEX	EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / SUBLINGUAL	RLD	2002-10-08	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020732-003	SUBUTEX	EQ 8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / SUBLINGUAL	RLD	2002-10-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020732-002	SUBUTEX	EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2002-10-08	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020732-003	SUBUTEX	EQ 8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2002-10-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020732-002	SUBUTEX	EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / SUBLINGUAL	RLD	2002-10-08	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020732-003	SUBUTEX	EQ 8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / SUBLINGUAL	RLD	2002-10-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020732-002	SUBUTEX	EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / SUBLINGUAL	RLD	2002-10-08	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020732-003	SUBUTEX	EQ 8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / SUBLINGUAL	RLD	2002-10-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020732-002	SUBUTEX	EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / SUBLINGUAL	RLD	2002-10-08	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020732-003	SUBUTEX	EQ 8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / SUBLINGUAL	RLD	2002-10-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020732-002	SUBUTEX	EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / SUBLINGUAL	RLD	2002-10-08	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020732-003	SUBUTEX	EQ 8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / SUBLINGUAL	RLD	2002-10-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020732-002	SUBUTEX	EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / SUBLINGUAL	RLD	2002-10-08	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020732-003	SUBUTEX	EQ 8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / SUBLINGUAL	RLD	2002-10-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020732-002	SUBUTEX	EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / SUBLINGUAL	RLD	2002-10-08	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020732-003	SUBUTEX	EQ 8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / SUBLINGUAL	RLD	2002-10-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020732-002	SUBUTEX	EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / SUBLINGUAL	RLD	2002-10-08	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020732-003	SUBUTEX	EQ 8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / SUBLINGUAL	RLD	2002-10-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020732-002	SUBUTEX	EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / SUBLINGUAL	RLD	2002-10-08	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020732-003	SUBUTEX	EQ 8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / SUBLINGUAL	RLD	2002-10-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020732-002	SUBUTEX	EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2002-10-08	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020732-003	SUBUTEX	EQ 8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2002-10-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020732-002	SUBUTEX	EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2002-10-08	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N020732-003	SUBUTEX	EQ 8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2002-10-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020732-002	SUBUTEX	EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2002-10-08	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N020732-003	SUBUTEX	EQ 8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2002-10-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020732-002	SUBUTEX	EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2002-10-08	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020732-003	SUBUTEX	EQ 8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2002-10-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020732-002	SUBUTEX	EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2002-10-08	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020732-003	SUBUTEX	EQ 8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2002-10-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020732-002	SUBUTEX	EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2002-10-08	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020732-003	SUBUTEX	EQ 8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2002-10-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020732-002	SUBUTEX	EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2002-10-08	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020732-003	SUBUTEX	EQ 8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2002-10-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020732-002	SUBUTEX	EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2002-10-08	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N020732-003	SUBUTEX	EQ 8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2002-10-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020732-002	SUBUTEX	EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2002-10-08	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N020732-003	SUBUTEX	EQ 8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2002-10-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020732-002	SUBUTEX	EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2002-10-08	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020732-003	SUBUTEX	EQ 8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2002-10-08	`3a93d1ddd44b…`

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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
buprenorphine hydrochloride	BUPRENORPHINE HYDROCHLORIDE	Advagen Pharma Ltd	699638dd-3a53-445f-a545-d0e6eabfe1c9	2026-07-17	Warnings, Adverse reactions	Name fallback generic name: BUPRENORPHINE HYDROCHLORIDE
buprenorphine hydrochloride	BUPRENORPHINE HYDROCHLORIDE	REMEDYREPACK INC.	11686845-f5fd-4e96-8a4f-9b132bf48840	2026-07-07	Warnings, Adverse reactions	Name fallback generic name: BUPRENORPHINE HYDROCHLORIDE
buprenorphine hydrochloride	BUPRENORPHINE HYDROCHLORIDE	PAI Holdings, LLC dba PAI Pharma	442831cf-9636-433a-9a12-e9a8cd31f72a	2026-02-28	Warnings, Adverse reactions	Name fallback generic name: BUPRENORPHINE HYDROCHLORIDE
BELBUCA	BUPRENORPHINE HYDROCHLORIDE	BioDelivery Sciences International Inc	bc2b7a3d-72cf-497c-95b0-ba2b71f63c64	2026-01-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPRENORPHINE HYDROCHLORIDE
Buprenorphine Hydrochloride	BUPRENORPHINE HYDROCHLORIDE	Hospira, Inc.	23aa1bb3-cecf-4e62-29bb-48488bb66fc3	2025-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPRENORPHINE HYDROCHLORIDE
Buprenorphine Hydrochloride	BUPRENORPHINE HYDROCHLORIDE	Par Health USA, LLC	34767dda-ce52-4f98-a45f-bb5cee0cd5e6	2025-12-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPRENORPHINE HYDROCHLORIDE
buprenorphine hydrochloride	BUPRENORPHINE HYDROCHLORIDE	A-S Medication Solutions	c1398d85-d4bb-4426-8ecf-a50400910d81	2025-05-28	Warnings, Adverse reactions	Name fallback generic name: BUPRENORPHINE HYDROCHLORIDE
Buprenorphine Hydrochloride	BUPRENORPHINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	adc1167e-910e-4d7b-abdc-751d3df0c3dc	2025-03-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPRENORPHINE HYDROCHLORIDE
Buprenorphine Hydrochloride	BUPRENORPHINE HYDROCHLORIDE	Somerset Therapeutics, LLC	74e40c51-853b-4e7f-b3cb-a27af29e1cbf	2025-02-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPRENORPHINE HYDROCHLORIDE

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 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63629-4092	Buprenorphine hydrochloride	Buprenorphine hydrochloride	bryant ranch prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
71388	SUPPL	2022-06-21
71387	SUPPL	2022-06-21
71386	SUPPL	2022-06-21
71365	SUPPL	2022-06-21
71364	SUPPL	2022-06-21
70983	SUPPL	2022-05-04
69378	SUPPL	2021-11-23
66583	SUPPL	2021-03-08
66582	SUPPL	2021-03-08
66503	SUPPL	2021-03-05
62026	SUPPL	2020-03-04
60770	SUPPL	2019-11-01
60768	SUPPL	2019-10-31
60767	SUPPL	2019-10-31
60469	SUPPL	2019-10-09
60467	SUPPL	2019-10-09
60357	SUPPL	2019-10-08
56143	SUPPL	2018-10-29
54618	SUPPL	2018-06-20
54612	SUPPL	2018-06-19
54595	SUPPL	2018-06-14
52286	SUPPL	2018-02-02
52249	SUPPL	2018-02-01
49841	SUPPL	2017-09-22
49807	SUPPL	2017-09-20
49696	SUPPL	2017-09-08
46369	SUPPL	2016-12-21
46368	SUPPL	2016-12-21
46263	SUPPL	2016-12-20
46262	SUPPL	2016-12-20
3224	SUPPL	2016-07-12
25655	SUPPL	2015-09-24
13308	SUPPL	2014-12-18
25654	SUPPL	2014-12-12
23979	ORIG	2012-01-05
25653	SUPPL	2012-01-03
3223	SUPPL	2012-01-03
35247	SUPPL	2011-12-23
13307	SUPPL	2011-12-23
3222	SUPPL	2006-10-13
41624	ORIG	2004-11-22
13306	ORIG	2002-10-08
3221	ORIG	2002-10-08