Application 090622

Type: ANDA
Sponsor: ETHYPHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BUPRENORPHINE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE	TABLET;SUBLINGUAL	EQ 2MG BASE	No	No
002	BUPRENORPHINE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE	TABLET;SUBLINGUAL	EQ 8MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A090622-001	BUPRENORPHINE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB		2010-09-24
A090622-002	BUPRENORPHINE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB		2010-09-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A090622-001	AB
A090622-002	AB

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 3 · 84 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
2026-08-18 06:07:40	2026-07	A090622-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2010-09-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090622-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2010-09-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090622-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2010-09-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090622-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2010-09-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090622-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2010-09-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090622-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2010-09-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090622-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2010-09-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090622-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2010-09-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090622-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2010-09-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090622-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2010-09-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090622-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2010-09-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090622-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2010-09-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090622-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2010-09-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090622-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2010-09-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090622-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2010-09-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090622-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2010-09-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090622-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2010-09-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090622-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2010-09-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090622-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2010-09-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090622-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2010-09-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090622-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2010-09-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090622-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2010-09-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090622-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2010-09-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090622-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2010-09-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090622-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2010-09-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090622-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2010-09-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090622-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2010-09-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090622-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2010-09-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090622-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2010-09-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090622-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2010-09-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090622-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2010-09-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090622-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2010-09-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090622-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2010-09-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090622-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2010-09-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090622-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2010-09-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090622-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2010-09-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090622-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2010-09-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090622-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2010-09-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090622-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2010-09-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090622-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2010-09-24	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A090622-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090622-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090622-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090622-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090622-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090622-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090622-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090622-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090622-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090622-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090622-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090622-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090622-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090622-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090622-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090622-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090622-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090622-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090622-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090622-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090622-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090622-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090622-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090622-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090622-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090622-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090622-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090622-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090622-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090622-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090622-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090622-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090622-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090622-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090622-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090622-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090622-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090622-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090622-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090622-002	AB	1	`bb7c543d1eb4…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
buprenorphine hydrochloride	BUPRENORPHINE HYDROCHLORIDE	REMEDYREPACK INC.	11686845-f5fd-4e96-8a4f-9b132bf48840	2026-07-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090622 application number: ANDA090622
buprenorphine hydrochloride	BUPRENORPHINE HYDROCHLORIDE	PAI Holdings, LLC dba PAI Pharma	442831cf-9636-433a-9a12-e9a8cd31f72a	2026-02-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090622 application number: ANDA090622
buprenorphine hydrochloride	BUPRENORPHINE HYDROCHLORIDE	A-S Medication Solutions	c1398d85-d4bb-4426-8ecf-a50400910d81	2025-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090622 application number: ANDA090622

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 31 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
35356-556	buprenorphine hydrochloride	buprenorphine hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
50090-1571	buprenorphine hydrochloride	buprenorphine hydrochloride	A-S Medication Solutions	ANDA	Current
50090-1571	buprenorphine hydrochloride	buprenorphine hydrochloride	A-S Medication Solutions	ANDA	Current
50090-1571	buprenorphine hydrochloride	buprenorphine hydrochloride	A-S Medication Solutions	ANDA	Current
50383-924	buprenorphine hydrochloride	buprenorphine hydrochloride	Hi-Tech Pharmacal Co. Inc.	ANDA	Current
50383-924	buprenorphine hydrochloride	buprenorphine hydrochloride	Hi-Tech Pharmacal Co. Inc.	ANDA	Current
50383-924	buprenorphine hydrochloride	buprenorphine hydrochloride	Hi-Tech Pharmacal Co., Inc.	ANDA	Current
50383-924	buprenorphine hydrochloride	buprenorphine hydrochloride	Hi-Tech Pharmacal Co., In	ANDA	Current
50383-924	buprenorphine hydrochloride	buprenorphine hydrochloride	Hi-Tech Pharmacal Co., Inc.	ANDA	Current
50383-924	buprenorphine hydrochloride	buprenorphine hydrochloride	Hi-Tech Pharmacal Co. Inc.	ANDA	Current
50383-924	buprenorphine hydrochloride	buprenorphine hydrochloride	Akorn Operating Company LLC (dba Akorn)	ANDA	Current
50383-924	buprenorphine hydrochloride	buprenorphine hydrochloride	Hi-Tech Pharmacal Co., Inc.	ANDA	Current
50383-930	buprenorphine hydrochloride	buprenorphine hydrochloride	Hi-Tech Pharmacal Co. Inc.	ANDA	Current
50383-930	buprenorphine hydrochloride	buprenorphine hydrochloride	Hi-Tech Pharmacal Co. Inc.	ANDA	Current
50383-930	buprenorphine hydrochloride	buprenorphine hydrochloride	Hi-Tech Pharmacal Co., Inc.	ANDA	Current
50383-930	buprenorphine hydrochloride	buprenorphine hydrochloride	Hi-Tech Pharmacal Co., In	ANDA	Current
50383-930	buprenorphine hydrochloride	buprenorphine hydrochloride	Hi-Tech Pharmacal Co., Inc.	ANDA	Current
50383-930	buprenorphine hydrochloride	buprenorphine hydrochloride	Hi-Tech Pharmacal Co. Inc.	ANDA	Current
50383-930	buprenorphine hydrochloride	buprenorphine hydrochloride	Akorn Operating Company LLC (dba Akorn)	ANDA	Current
50383-930	buprenorphine hydrochloride	buprenorphine hydrochloride	Hi-Tech Pharmacal Co., Inc.	ANDA	Current
53217-246	buprenorphine hydrochloride	buprenorphine hydrochloride	Aidarex Pharmaceuticals LLC	ANDA	Current
63629-7125	buprenorphine hydrochloride	buprenorphine hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-7125	buprenorphine hydrochloride	buprenorphine hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-7126	buprenorphine hydrochloride	buprenorphine hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-7126	buprenorphine hydrochloride	buprenorphine hydrochloride	Bryant Ranch Prepack	ANDA	Current
64725-0930	buprenorphine hydrochloride	buprenorphine hydrochloride	TYA Pharmaceuticals	ANDA	Current
64725-1924	buprenorphine hydrochloride	buprenorphine hydrochloride	TYA Pharmaceuticals	ANDA	Current
67046-990	buprenorphine hydrochloride	buprenorphine hydrochloride	Contract Pharmacy Services-PA	ANDA	Current
67046-991	buprenorphine hydrochloride	buprenorphine hydrochloride	Contract Pharmacy Services-PA	ANDA	Current
70518-0442	buprenorphine hydrochloride	buprenorphine hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2216	buprenorphine hydrochloride	buprenorphine hydrochloride	REMEDYREPACK INC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
24070	ORIG	2015-07-02