Application 078331

Type: ANDA
Sponsor: AM REGENT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BUPRENORPHINE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 0.3MG BASE/ML	No	No

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078331-001	BUPRENORPHINE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE	EQ 0.3MG BASE/ML	INJECTABLE / INJECTION			2007-03-27

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 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2022-09-29 23:25 UTC	2022-09	A078331-001	BUPRENORPHINE HYDROCHLORIDE	EQ 0.3MG BASE/ML	INJECTABLE / INJECTION	AP	2007-03-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078331-001	BUPRENORPHINE HYDROCHLORIDE	EQ 0.3MG BASE/ML	INJECTABLE / INJECTION	AP	2007-03-27	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A078331-001	BUPRENORPHINE HYDROCHLORIDE	EQ 0.3MG BASE/ML	INJECTABLE / INJECTION		2007-03-27	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078331-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078331-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078331-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078331-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078331-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078331-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078331-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078331-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078331-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078331-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078331-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078331-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078331-001	AP	1	`ea99ee380514…`
2023-12-20 04:57 UTC	2023-12	A078331-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078331-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078331-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078331-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078331-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078331-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078331-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078331-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078331-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078331-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078331-001	AP	1	`cb3db0bc1861…`

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 brand name: buprenorphine hydrochloride generic name: BUPRENORPHINE HYDROCHLORIDE
buprenorphine hydrochloride	BUPRENORPHINE HYDROCHLORIDE	REMEDYREPACK INC.	11686845-f5fd-4e96-8a4f-9b132bf48840	2026-07-07	Warnings, Adverse reactions	Name fallback brand name: buprenorphine hydrochloride 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 brand name: buprenorphine hydrochloride 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 brand name: Buprenorphine Hydrochloride 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 brand name: Buprenorphine Hydrochloride 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 brand name: buprenorphine hydrochloride 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 brand name: Buprenorphine Hydrochloride 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 brand name: Buprenorphine Hydrochloride 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 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0517-0725	Buprenorphine Hydrochloride	Buprenorphine Hydrochloride	American Regent, Inc.	ANDA	Current
0517-0725	Buprenorphine Hydrochloride	Buprenorphine Hydrochloride	American Regent, Inc.	ANDA	Current
0517-0725	Buprenorphine Hydrochloride	Buprenorphine Hydrochloride	American Regent, Inc.	ANDA	Current