Application 074288

Type: ANDA
Sponsor: MYLAN

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 44.

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
A074288-001	ACEBUTOLOL HYDROCHLORIDE	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL			1995-04-24
A074288-002	ACEBUTOLOL HYDROCHLORIDE	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL			1995-04-24

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 3 · 88 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
2019-12-13 00:20 UTC	2019-12	A074288-001	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB	1995-04-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074288-002	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL	AB	1995-04-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074288-001	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB	1995-04-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A074288-002	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL	AB	1995-04-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074288-001	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB	1995-04-24	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A074288-002	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL	AB	1995-04-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074288-001	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB	1995-04-24	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074288-002	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL	AB	1995-04-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074288-001	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB	1995-04-24	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A074288-002	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL	AB	1995-04-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074288-001	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB	1995-04-24	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A074288-002	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL	AB	1995-04-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074288-001	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB	1995-04-24	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A074288-002	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL	AB	1995-04-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074288-001	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB	1995-04-24	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A074288-002	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL	AB	1995-04-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074288-001	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB	1995-04-24	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A074288-002	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL	AB	1995-04-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074288-001	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB	1995-04-24	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A074288-002	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL	AB	1995-04-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074288-001	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL		1995-04-24	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074288-002	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL		1995-04-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074288-001	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL		1995-04-24	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A074288-002	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL		1995-04-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074288-001	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL		1995-04-24	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A074288-002	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL		1995-04-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074288-001	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL		1995-04-24	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074288-002	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL		1995-04-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074288-001	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL		1995-04-24	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074288-002	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL		1995-04-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074288-001	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL		1995-04-24	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074288-002	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL		1995-04-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074288-001	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL		1995-04-24	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074288-002	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL		1995-04-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074288-001	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL		1995-04-24	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A074288-002	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL		1995-04-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074288-001	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL		1995-04-24	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A074288-002	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL		1995-04-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074288-001	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL		1995-04-24	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074288-002	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL		1995-04-24	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-04-08 23:34 UTC	2022-04	A074288-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074288-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074288-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074288-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074288-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074288-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074288-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A074288-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074288-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A074288-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074288-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074288-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074288-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A074288-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074288-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A074288-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074288-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A074288-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074288-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A074288-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074288-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A074288-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074288-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A074288-002	AB	1	`ea99ee380514…`

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 · 6 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	Name fallback brand name: Acebutolol Hydrochloride generic name: ACEBUTOLOL HYDROCHLORIDE
Acebutolol Hydrochloride	ACEBUTOLOL HYDROCHLORIDE	Golden State Medical Supply, Inc.	f037a079-fde6-3588-e053-2995a90a6621	2025-12-17	Warnings, Adverse reactions	Name fallback brand name: Acebutolol Hydrochloride generic name: ACEBUTOLOL HYDROCHLORIDE
Acebutolol Hydrochloride	ACEBUTOLOL HYDROCHLORIDE	ANI Pharmaceuticals, Inc.	48bded12-09c7-47f2-b162-ec970a77f2d8	2025-11-07	Warnings, Adverse reactions	Name fallback brand name: Acebutolol Hydrochloride generic name: ACEBUTOLOL HYDROCHLORIDE
Acebutolol Hydrochloride	ACEBUTOLOL HYDROCHLORIDE	AvPAK	ff68a002-d46d-4f9f-0705-427844ea3655	2025-09-18	Warnings, Adverse reactions	Name fallback brand name: Acebutolol Hydrochloride generic name: ACEBUTOLOL HYDROCHLORIDE
Acebutolol Hydrochloride	ACEBUTOLOL HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	fe2cd5c0-ee16-4bcb-ad92-3755881dbe79	2024-12-11	Warnings, Adverse reactions	Name fallback brand name: Acebutolol Hydrochloride generic name: ACEBUTOLOL HYDROCHLORIDE
Acebutolol Hydrochloride	ACEBUTOLOL HYDROCHLORIDE	Amneal Pharmaceuticals LLC	28f8c26c-a1e1-4485-a45f-05c82f7a34b5	2024-10-23	Warnings, Adverse reactions	Name fallback brand name: Acebutolol Hydrochloride generic name: ACEBUTOLOL 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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-1200	Acebutolol Hydrochloride	acebutolol hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1200	Acebutolol Hydrochloride	acebutolol hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1400	Acebutolol Hydrochloride	acebutolol hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1400	Acebutolol Hydrochloride	acebutolol hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current