Application 090819

Type: ANDA
Sponsor: ACTAVIS ELIZABETH

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 1.

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
A090819-001	BUPRENORPHINE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB		2015-02-19
A090819-002	BUPRENORPHINE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB		2015-02-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090819-001	AB
A090819-002	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 · 82 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
2026-02-19 14:30 UTC	2026-02	A090819-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2015-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090819-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2015-02-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090819-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2015-02-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090819-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2015-02-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090819-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2015-02-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090819-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2015-02-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090819-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2015-02-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090819-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2015-02-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090819-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2015-02-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090819-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2015-02-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090819-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2015-02-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090819-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2015-02-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090819-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2015-02-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090819-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2015-02-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090819-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2015-02-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090819-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2015-02-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090819-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2015-02-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090819-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2015-02-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090819-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2015-02-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090819-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2015-02-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090819-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2015-02-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090819-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2015-02-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090819-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2015-02-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090819-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2015-02-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090819-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2015-02-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090819-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2015-02-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090819-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2015-02-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090819-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2015-02-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090819-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2015-02-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090819-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2015-02-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090819-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2015-02-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090819-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2015-02-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090819-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2015-02-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090819-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2015-02-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090819-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2015-02-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090819-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2015-02-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090819-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2015-02-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090819-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2015-02-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090819-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2015-02-19	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090819-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2015-02-19	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090819-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090819-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090819-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090819-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090819-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090819-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090819-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090819-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090819-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090819-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090819-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090819-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090819-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090819-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090819-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090819-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090819-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090819-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090819-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090819-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090819-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090819-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090819-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090819-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090819-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090819-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090819-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090819-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090819-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090819-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090819-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090819-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090819-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090819-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090819-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090819-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090819-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090819-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090819-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090819-002	AB	1	`782e0a99824c…`

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
Buprenorphine	BUPRENORPHINE	REMEDYREPACK INC.	aa86a438-1ebf-4c08-bf27-38f1e81efb3a	2026-07-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090819 application number: ANDA090819 ndc (product): 70518-1557
Buprenorphine	BUPRENORPHINE	Actavis Pharma, Inc.	03819118-86f6-4329-adaf-4599e7b71f46	2026-05-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090819 application number: ANDA090819 ndc (product): 0228-3153 ndc (product): 0228-3156

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 32 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0228-3153	Buprenorphine	Buprenorphine	Actavis Pharma, Inc.	ANDA	Current
0228-3153	Buprenorphine	Buprenorphine	Actavis Pharma, Inc.	ANDA	Current
0228-3153	Buprenorphine	Buprenorphine	Actavis Pharma, Inc.	ANDA	Current
0228-3153	Buprenorphine	Buprenorphine	Actavis Pharma, Inc.	ANDA	Current
0228-3153	Buprenorphine	Buprenorphine	Actavis Pharma, Inc.	ANDA	Current
0228-3153	Buprenorphine	Buprenorphine	Actavis Pharma, Inc.	ANDA	Current
0228-3153	Buprenorphine	Buprenorphine	Actavis Pharma, Inc.	ANDA	Current
0228-3153	Buprenorphine	Buprenorphine	Actavis Pharma, Inc.	ANDA	Current
0228-3153	Buprenorphine	Buprenorphine	Actavis Pharma, Inc.	ANDA	Current
0228-3153	Buprenorphine	Buprenorphine	Actavis Pharma, Inc.	ANDA	Current
0228-3156	Buprenorphine	Buprenorphine	Actavis Pharma, Inc.	ANDA	Current
0228-3156	Buprenorphine	Buprenorphine	Actavis Pharma, Inc.	ANDA	Current
0228-3156	Buprenorphine	Buprenorphine	Actavis Pharma, Inc.	ANDA	Current
0228-3156	Buprenorphine	Buprenorphine	Actavis Pharma, Inc.	ANDA	Current
0228-3156	Buprenorphine	Buprenorphine	Actavis Pharma, Inc.	ANDA	Current
0228-3156	Buprenorphine	Buprenorphine	Actavis Pharma, Inc.	ANDA	Current
0228-3156	Buprenorphine	Buprenorphine	Actavis Pharma, Inc.	ANDA	Current
0228-3156	Buprenorphine	Buprenorphine	Actavis Pharma, Inc.	ANDA	Current
0228-3156	Buprenorphine	Buprenorphine	Actavis Pharma, Inc.	ANDA	Current
0228-3156	Buprenorphine	Buprenorphine	Actavis Pharma, Inc.	ANDA	Current
50090-2924	Buprenorphine	Buprenorphine Hydrochloride	A-S Medication Solutions	ANDA	Current
58118-3156	Buprenorphine	Buprenorphine	Clinical Solutions Wholesale, LLC	ANDA	Current
58118-3156	Buprenorphine	Buprenorphine	Clinical Solutions Wholesale, LLC	ANDA	Current
70518-1557	Buprenorphine	Buprenorphine	REMEDYREPACK INC.	ANDA	Current
70518-1557	Buprenorphine	Buprenorphine	REMEDYREPACK INC.	ANDA	Current
70518-1625	Buprenorphine	Buprenorphine	REMEDYREPACK INC.	ANDA	Current
70518-1625	Buprenorphine	Buprenorphine	REMEDYREPACK INC.	ANDA	Current
70518-1625	Buprenorphine	Buprenorphine	REMEDYREPACK INC.	ANDA	Current
71335-0353	Buprenorphine	Buprenorphine	Bryant Ranch Prepack	ANDA	Current
71335-0353	Buprenorphine	Buprenorphine	Bryant Ranch Prepack	ANDA	Current
71335-0353	Buprenorphine	Buprenorphine	Bryant Ranch Prepack	ANDA	Current
71335-0353	Buprenorphine	Buprenorphine	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
44554	ORIG	2015-07-02
31499	ORIG	2015-02-24