Application 075047

Type: ANDA
Sponsor: AMNEAL PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ACEBUTOLOL HYDROCHLORIDE	ACEBUTOLOL HYDROCHLORIDE	CAPSULE;ORAL	EQ 200MG BASE	No	Yes
002	ACEBUTOLOL HYDROCHLORIDE	ACEBUTOLOL HYDROCHLORIDE	CAPSULE;ORAL	EQ 400MG BASE	No	Yes

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
A075047-001	ACEBUTOLOL HYDROCHLORIDE	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB	RS	1999-12-30
A075047-002	ACEBUTOLOL HYDROCHLORIDE	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL	AB	RS	1999-12-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075047-001	AB
A075047-002	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075047-001	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB	RS	1999-12-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075047-002	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL	AB	RS	1999-12-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075047-001	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB	RS	1999-12-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075047-002	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL	AB	RS	1999-12-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075047-001	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB	RS	1999-12-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075047-002	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL	AB	RS	1999-12-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075047-001	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB	RS	1999-12-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075047-002	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL	AB	RS	1999-12-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075047-001	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB	RS	1999-12-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075047-002	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL	AB	RS	1999-12-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075047-001	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB	RS	1999-12-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075047-002	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL	AB	RS	1999-12-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075047-001	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB	RS	1999-12-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075047-002	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL	AB	RS	1999-12-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075047-001	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB	RS	1999-12-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075047-002	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL	AB	RS	1999-12-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075047-001	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB	RS	1999-12-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075047-002	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL	AB	RS	1999-12-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075047-001	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB	RS	1999-12-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075047-002	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL	AB	RS	1999-12-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075047-001	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB	RS	1999-12-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075047-002	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL	AB	RS	1999-12-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075047-001	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB	RS	1999-12-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075047-002	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL	AB	RS	1999-12-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075047-001	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB	RS	1999-12-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075047-002	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL	AB	RS	1999-12-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075047-001	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB	RS	1999-12-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075047-002	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL	AB	RS	1999-12-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075047-001	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL		RS	1999-12-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075047-002	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL		RS	1999-12-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075047-001	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB	RS	1999-12-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075047-002	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL	AB	RS	1999-12-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075047-001	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB	RS	1999-12-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075047-002	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL	AB	RS	1999-12-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075047-001	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB	RS	1999-12-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075047-002	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL	AB	RS	1999-12-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075047-001	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB	RS	1999-12-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075047-002	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL	AB	RS	1999-12-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075047-001	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB	RS	1999-12-30	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075047-002	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL	AB	RS	1999-12-30	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 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	A075047-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075047-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075047-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075047-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075047-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075047-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075047-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075047-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075047-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075047-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075047-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075047-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075047-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075047-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075047-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075047-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075047-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075047-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075047-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075047-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075047-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075047-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075047-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075047-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075047-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075047-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075047-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075047-002	AB	1	`8072bd15b7f6…`
2022-04-08 23:34 UTC	2022-04	A075047-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075047-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075047-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075047-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075047-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075047-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075047-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075047-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075047-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075047-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075047-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075047-002	AB	1	`87673890dc5c…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acebutolol Hydrochloride	ACEBUTOLOL HYDROCHLORIDE	AvKARE	fa40a564-a579-15c1-e053-6294a90ad8e9	2026-01-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075047 application number: ANDA075047
Acebutolol Hydrochloride	ACEBUTOLOL HYDROCHLORIDE	AvPAK	ff68a002-d46d-4f9f-0705-427844ea3655	2025-09-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075047 application number: ANDA075047 ndc (product): 50268-050
Acebutolol Hydrochloride	ACEBUTOLOL HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	fe2cd5c0-ee16-4bcb-ad92-3755881dbe79	2024-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075047 application number: ANDA075047 ndc (product): 53746-670 ndc (product): 53746-669
Acebutolol Hydrochloride	ACEBUTOLOL HYDROCHLORIDE	Amneal Pharmaceuticals LLC	28f8c26c-a1e1-4485-a45f-05c82f7a34b5	2024-10-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075047 application number: ANDA075047 ndc (product): 65162-670 ndc (product): 65162-669

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 27 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10135-630	Acebutolol Hydrochloride	Acebutolol Hydrochloride	Marlex Pharmaceuticals Inc	ANDA	Current
10135-630	Acebutolol Hydrochloride	Acebutolol Hydrochloride	Marlex Pharmaceuticals Inc	ANDA	Current
10135-630	Acebutolol Hydrochloride	Acebutolol Hydrochloride	Marlex Pharmaceuticals Inc	ANDA	Current
10135-631	Acebutolol Hydrochloride	Acebutolol Hydrochloride	Marlex Pharmaceuticals Inc	ANDA	Current
10135-631	Acebutolol Hydrochloride	Acebutolol Hydrochloride	Marlex Pharmaceuticals Inc	ANDA	Current
10135-631	Acebutolol Hydrochloride	Acebutolol Hydrochloride	Marlex Pharmaceuticals Inc	ANDA	Current
42291-101	Acebutolol Hydrochloride	Acebutolol Hydrochloride	AvKARE, Inc.	ANDA	Current
42291-101	Acebutolol Hydrochloride	Acebutolol Hydrochloride	AvKARE, Inc.	ANDA	Current
42291-102	Acebutolol Hydrochloride	Acebutolol Hydrochloride	AvKARE, Inc.	ANDA	Current
50268-050	Acebutolol Hydrochloride	Acebutolol Hydrochloride	AvPAK	ANDA	Current
50268-050	Acebutolol Hydrochloride	Acebutolol Hydrochloride	AvPAK	ANDA	Current
53746-669	Acebutolol Hydrochloride	Acebutolol Hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-669	Acebutolol Hydrochloride	Acebutolol Hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-669	Acebutolol Hydrochloride	Acebutolol Hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-669	Acebutolol Hydrochloride	Acebutolol Hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-670	Acebutolol Hydrochloride	Acebutolol Hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-670	Acebutolol Hydrochloride	Acebutolol Hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-670	Acebutolol Hydrochloride	Acebutolol Hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-670	Acebutolol Hydrochloride	Acebutolol Hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
65162-669	Acebutolol Hydrochloride	Acebutolol Hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
65162-669	Acebutolol Hydrochloride	Acebutolol Hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
65162-669	Acebutolol Hydrochloride	Acebutolol Hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
65162-669	Acebutolol Hydrochloride	Acebutolol Hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
65162-670	Acebutolol Hydrochloride	Acebutolol Hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
65162-670	Acebutolol Hydrochloride	Acebutolol Hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
65162-670	Acebutolol Hydrochloride	Acebutolol Hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
65162-670	Acebutolol Hydrochloride	Acebutolol Hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
22407	ORIG	2012-02-14
8499	ORIG	1999-12-30