Application 074007

Type: ANDA
Sponsor: ANI PHARMS INC

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	No
002	ACEBUTOLOL HYDROCHLORIDE	ACEBUTOLOL HYDROCHLORIDE	CAPSULE;ORAL	EQ 400MG 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
A074007-001	ACEBUTOLOL HYDROCHLORIDE	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB		1995-10-18
A074007-002	ACEBUTOLOL HYDROCHLORIDE	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL	AB		1995-10-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074007-001	AB
A074007-002	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	A074007-001	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB	1995-10-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074007-002	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL	AB	1995-10-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074007-001	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB	1995-10-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074007-002	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL	AB	1995-10-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074007-001	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB	1995-10-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074007-002	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL	AB	1995-10-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074007-001	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB	1995-10-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074007-002	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL	AB	1995-10-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074007-001	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB	1995-10-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074007-002	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL	AB	1995-10-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074007-001	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB	1995-10-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074007-002	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL	AB	1995-10-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074007-001	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB	1995-10-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074007-002	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL	AB	1995-10-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074007-001	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB	1995-10-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074007-002	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL	AB	1995-10-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074007-001	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB	1995-10-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074007-002	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL	AB	1995-10-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074007-001	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB	1995-10-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074007-002	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL	AB	1995-10-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074007-001	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB	1995-10-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074007-002	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL	AB	1995-10-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074007-001	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB	1995-10-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074007-002	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL	AB	1995-10-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074007-001	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB	1995-10-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074007-002	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL	AB	1995-10-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074007-001	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB	1995-10-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074007-002	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL	AB	1995-10-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074007-001	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB	1995-10-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074007-002	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL	AB	1995-10-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074007-001	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL		1995-10-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074007-002	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL		1995-10-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074007-001	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL		1995-10-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074007-002	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL		1995-10-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074007-001	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL		1995-10-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074007-002	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL		1995-10-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074007-001	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL		1995-10-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074007-002	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL		1995-10-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074007-001	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL		1995-10-18	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A074007-002	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL		1995-10-18	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 56 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	A074007-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074007-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074007-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074007-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074007-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074007-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074007-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074007-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074007-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074007-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074007-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074007-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074007-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074007-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074007-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074007-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074007-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074007-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074007-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074007-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074007-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074007-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074007-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074007-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074007-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074007-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074007-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074007-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074007-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074007-002	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074007-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074007-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074007-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A074007-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074007-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A074007-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074007-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074007-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074007-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074007-002	AB	1	`9b2671bbb829…`

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
Acebutolol Hydrochloride	ACEBUTOLOL HYDROCHLORIDE	Golden State Medical Supply, Inc.	f037a079-fde6-3588-e053-2995a90a6621	2025-12-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074007 application number: ANDA074007 ndc (product): 51407-666 ndc (product): 51407-667
Acebutolol Hydrochloride	ACEBUTOLOL HYDROCHLORIDE	ANI Pharmaceuticals, Inc.	48bded12-09c7-47f2-b162-ec970a77f2d8	2025-11-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074007 application number: ANDA074007 ndc (product): 62559-256 ndc (product): 62559-255

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51407-666	Acebutolol Hydrochloride	Acebutolol Hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
51407-667	Acebutolol Hydrochloride	Acebutolol Hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
62559-255	Acebutolol Hydrochloride	Acebutolol Hydrochloride	ANI Pharmaceuticals, Inc.	ANDA	Current
62559-255	Acebutolol Hydrochloride	Acebutolol Hydrochloride	ANI Pharmaceuticals, Inc.	ANDA	Current
62559-256	Acebutolol Hydrochloride	Acebutolol Hydrochloride	ANI Pharmaceuticals, Inc.	ANDA	Current
62559-256	Acebutolol Hydrochloride	Acebutolol Hydrochloride	ANI Pharmaceuticals, Inc.	ANDA	Current