Application 075541

Type: ANDA
Sponsor: EPIC PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BETAXOLOL HYDROCHLORIDE	BETAXOLOL HYDROCHLORIDE	TABLET;ORAL	10MG	No	No
002	BETAXOLOL HYDROCHLORIDE	BETAXOLOL HYDROCHLORIDE	TABLET;ORAL	20MG	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
A075541-001	BETAXOLOL HYDROCHLORIDE	BETAXOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	AB		1999-10-22
A075541-002	BETAXOLOL HYDROCHLORIDE	BETAXOLOL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	RS	1999-10-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075541-001	AB
A075541-002	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	A075541-001	BETAXOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	AB		1999-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075541-002	BETAXOLOL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	RS	1999-10-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075541-001	BETAXOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	AB		1999-10-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075541-002	BETAXOLOL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	RS	1999-10-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075541-001	BETAXOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	AB		1999-10-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075541-002	BETAXOLOL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	RS	1999-10-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075541-001	BETAXOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	AB		1999-10-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075541-002	BETAXOLOL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	RS	1999-10-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075541-001	BETAXOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	AB		1999-10-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075541-002	BETAXOLOL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	RS	1999-10-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075541-001	BETAXOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	AB		1999-10-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075541-002	BETAXOLOL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	RS	1999-10-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075541-001	BETAXOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	AB		1999-10-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075541-002	BETAXOLOL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	RS	1999-10-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075541-001	BETAXOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	AB		1999-10-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075541-002	BETAXOLOL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	RS	1999-10-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075541-001	BETAXOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	AB		1999-10-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075541-002	BETAXOLOL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	RS	1999-10-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075541-001	BETAXOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	AB		1999-10-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075541-002	BETAXOLOL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	RS	1999-10-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075541-001	BETAXOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	AB		1999-10-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075541-002	BETAXOLOL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	RS	1999-10-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075541-001	BETAXOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	AB		1999-10-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075541-002	BETAXOLOL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	RS	1999-10-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075541-001	BETAXOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	AB		1999-10-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075541-002	BETAXOLOL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	RS	1999-10-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075541-001	BETAXOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	AB		1999-10-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075541-002	BETAXOLOL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	RS	1999-10-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075541-001	BETAXOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	AB		1999-10-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075541-002	BETAXOLOL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	RS	1999-10-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075541-001	BETAXOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	AB		1999-10-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075541-002	BETAXOLOL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	RS	1999-10-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075541-001	BETAXOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	AB		1999-10-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075541-002	BETAXOLOL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	RS	1999-10-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075541-001	BETAXOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	AB		1999-10-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075541-002	BETAXOLOL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	RS	1999-10-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075541-001	BETAXOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	AB		1999-10-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075541-002	BETAXOLOL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	RS	1999-10-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075541-001	BETAXOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	AB		1999-10-22	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075541-002	BETAXOLOL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	RS	1999-10-22	`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	A075541-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075541-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075541-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075541-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075541-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075541-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075541-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075541-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075541-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075541-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075541-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075541-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075541-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075541-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075541-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075541-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075541-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075541-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075541-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075541-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075541-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075541-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075541-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075541-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075541-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075541-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075541-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075541-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075541-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075541-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075541-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075541-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075541-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075541-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075541-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075541-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075541-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075541-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075541-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075541-002	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
Betaxolol	BETAXOLOL	Epic Pharma LLC	bf716efe-0a9f-43b1-9d8a-c69330b82e18	2023-12-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075541 application number: ANDA075541 ndc (product): 42806-038 ndc (product): 42806-039
Betaxolol	BETAXOLOL	PuraCap Laboratories LLC	e198244d-fda3-4015-8c01-390f3f88e238	2019-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075541 application number: ANDA075541 ndc (product): 24658-700 ndc (product): 24658-701

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10135-623	Betaxolol	Betaxolol	Marlex Pharmaceuticals Inc	ANDA	Current
10135-624	Betaxolol	Betaxolol	Marlex Pharmaceuticals Inc	ANDA	Current
24658-700	Betaxolol	Betaxolol	PuraCap Laboratories LLC	ANDA	Current
24658-700	Betaxolol	Betaxolol	PuraCap Laboratories LLC dba Blu Pharmaceuticals	ANDA	Current
24658-701	Betaxolol	Betaxolol	PuraCap Laboratories LLC	ANDA	Current
24658-701	Betaxolol	Betaxolol	PuraCap Laboratories LLC dba Blu Pharmaceuticals	ANDA	Current
42806-038	Betaxolol	Betaxolol	Epic Pharma LLC	ANDA	Current
42806-039	Betaxolol	Betaxolol	Epic Pharma LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
18412	SUPPL	2014-12-31
8713	SUPPL	2014-12-31
30927	ORIG	1999-10-22