Application 073457

Type: ANDA
Sponsor: MYLAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ATENOLOL	ATENOLOL	TABLET;ORAL	100MG	No	No
002	ATENOLOL	ATENOLOL	TABLET;ORAL	25MG	No	No
003	ATENOLOL	ATENOLOL	TABLET;ORAL	50MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A073457-001	ATENOLOL	ATENOLOL	100MG	TABLET / ORAL	AB	1992-01-24
A073457-002	ATENOLOL	ATENOLOL	25MG	TABLET / ORAL	AB	1999-04-26
A073457-003	ATENOLOL	ATENOLOL	50MG	TABLET / ORAL	AB	1992-01-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A073457-001	AB
A073457-002	AB
A073457-003	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 4 · 123 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	A073457-001	ATENOLOL	100MG	TABLET / ORAL	AB	1992-01-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A073457-002	ATENOLOL	25MG	TABLET / ORAL	AB	1999-04-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A073457-003	ATENOLOL	50MG	TABLET / ORAL	AB	1992-01-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073457-001	ATENOLOL	100MG	TABLET / ORAL	AB	1992-01-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073457-002	ATENOLOL	25MG	TABLET / ORAL	AB	1999-04-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073457-003	ATENOLOL	50MG	TABLET / ORAL	AB	1992-01-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A073457-001	ATENOLOL	100MG	TABLET / ORAL	AB	1992-01-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A073457-002	ATENOLOL	25MG	TABLET / ORAL	AB	1999-04-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A073457-003	ATENOLOL	50MG	TABLET / ORAL	AB	1992-01-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073457-001	ATENOLOL	100MG	TABLET / ORAL	AB	1992-01-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073457-002	ATENOLOL	25MG	TABLET / ORAL	AB	1999-04-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073457-003	ATENOLOL	50MG	TABLET / ORAL	AB	1992-01-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073457-001	ATENOLOL	100MG	TABLET / ORAL	AB	1992-01-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073457-002	ATENOLOL	25MG	TABLET / ORAL	AB	1999-04-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073457-003	ATENOLOL	50MG	TABLET / ORAL	AB	1992-01-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073457-001	ATENOLOL	100MG	TABLET / ORAL	AB	1992-01-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073457-002	ATENOLOL	25MG	TABLET / ORAL	AB	1999-04-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073457-003	ATENOLOL	50MG	TABLET / ORAL	AB	1992-01-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073457-001	ATENOLOL	100MG	TABLET / ORAL	AB	1992-01-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073457-002	ATENOLOL	25MG	TABLET / ORAL	AB	1999-04-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073457-003	ATENOLOL	50MG	TABLET / ORAL	AB	1992-01-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073457-001	ATENOLOL	100MG	TABLET / ORAL	AB	1992-01-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073457-002	ATENOLOL	25MG	TABLET / ORAL	AB	1999-04-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073457-003	ATENOLOL	50MG	TABLET / ORAL	AB	1992-01-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073457-001	ATENOLOL	100MG	TABLET / ORAL	AB	1992-01-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073457-002	ATENOLOL	25MG	TABLET / ORAL	AB	1999-04-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073457-003	ATENOLOL	50MG	TABLET / ORAL	AB	1992-01-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A073457-001	ATENOLOL	100MG	TABLET / ORAL	AB	1992-01-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A073457-002	ATENOLOL	25MG	TABLET / ORAL	AB	1999-04-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A073457-003	ATENOLOL	50MG	TABLET / ORAL	AB	1992-01-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073457-001	ATENOLOL	100MG	TABLET / ORAL	AB	1992-01-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073457-002	ATENOLOL	25MG	TABLET / ORAL	AB	1999-04-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073457-003	ATENOLOL	50MG	TABLET / ORAL	AB	1992-01-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073457-001	ATENOLOL	100MG	TABLET / ORAL	AB	1992-01-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073457-002	ATENOLOL	25MG	TABLET / ORAL	AB	1999-04-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073457-003	ATENOLOL	50MG	TABLET / ORAL	AB	1992-01-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073457-001	ATENOLOL	100MG	TABLET / ORAL	AB	1992-01-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073457-002	ATENOLOL	25MG	TABLET / ORAL	AB	1999-04-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073457-003	ATENOLOL	50MG	TABLET / ORAL	AB	1992-01-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A073457-001	ATENOLOL	100MG	TABLET / ORAL	AB	1992-01-24	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A073457-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A073457-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A073457-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073457-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073457-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073457-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A073457-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A073457-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A073457-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073457-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073457-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073457-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073457-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073457-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073457-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073457-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073457-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073457-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073457-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073457-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073457-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073457-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073457-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073457-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073457-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073457-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073457-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A073457-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A073457-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A073457-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073457-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073457-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073457-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073457-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073457-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073457-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073457-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073457-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073457-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A073457-001	AB	1	`8072bd15b7f6…`

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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Atenolol	ATENOLOL	Cardinal Health 107, LLC	0fadc652-b075-46ec-ae05-beaf7d91ae13	2026-07-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073457 application number: ANDA073457
Atenolol	ATENOLOL	Safecor Health, LLC	35d04cfd-34d4-429c-b990-a6c00137bc77	2026-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073457 application number: ANDA073457
Atenolol	ATENOLOL	Golden State Medical Supply, Inc.	f4f06c00-9024-4e04-a882-0da2b24d8ff7	2026-06-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073457 application number: ANDA073457
Atenolol	ATENOLOL	Cardinal Health 107, LLC	15c0c2df-f195-45f9-a1e4-1ed2a43c2216	2026-04-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073457 application number: ANDA073457
Atenolol	ATENOLOL	Mylan Pharmaceuticals Inc.	a7048c81-6769-436b-8397-fbaa7489fcdf	2026-02-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073457 application number: ANDA073457
Atenolol	ATENOLOL	Northwind Health Company, LLC	f318707a-4fb9-604c-e053-2a95a90ae973	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073457 application number: ANDA073457
Atenolol	ATENOLOL	Northwind Health Company, LLC	d9cdc2ed-99bf-0d6a-e053-2a95a90a0262	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073457 application number: ANDA073457
Atenolol	ATENOLOL	Mylan Institutional Inc.	8dd93a47-d14c-49be-9c22-97c0cdbec75a	2025-07-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073457 application number: ANDA073457
ATENOLOL	ATENOLOL	direct rx	b3d9f826-7ed7-1e3b-e053-2995a90ae731	2025-01-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073457 application number: ANDA073457 ndc (product): 72189-146
Atenolol	ATENOLOL	Aphena Pharma Solutions - Tennessee, LLC	9aef7a49-d21f-4529-8abf-68bdc343bb6c	2022-08-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073457 application number: ANDA073457
Atenolol	ATENOLOL	Proficient Rx LP	e115f27a-6a7c-498c-b4a1-2d4c5716af22	2020-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073457 application number: ANDA073457
Atenolol	ATENOLOL	Aphena Pharma Solutions - Tennessee, LLC	b02b4be4-b75c-4153-b402-cf330a077439	2017-12-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073457 application number: ANDA073457

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 83 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
72189-146	ATENOLOL	ATENOLOL	direct rx	ANDA	Current
72189-146	ATENOLOL	ATENOLOL	direct rx	ANDA	Current
72189-146	Atenolol	Atenolol	direct rx	ANDA	Current