Application 073026

Type: ANDA
Sponsor: HLTHCARE

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
A073026-001	ATENOLOL	ATENOLOL	100MG	TABLET / ORAL	AB	1991-09-17
A073026-002	ATENOLOL	ATENOLOL	25MG	TABLET / ORAL	AB	1992-05-01
A073026-003	ATENOLOL	ATENOLOL	50MG	TABLET / ORAL	AB	1991-09-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A073026-001	AB
A073026-002	AB
A073026-003	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 3 · 115 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	A073026-001	ATENOLOL	100MG	TABLET / ORAL	AB	1991-09-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A073026-002	ATENOLOL	25MG	TABLET / ORAL	AB	1992-05-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A073026-003	ATENOLOL	50MG	TABLET / ORAL	AB	1991-09-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073026-001	ATENOLOL	100MG	TABLET / ORAL	AB	1991-09-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073026-002	ATENOLOL	25MG	TABLET / ORAL	AB	1992-05-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073026-003	ATENOLOL	50MG	TABLET / ORAL	AB	1991-09-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A073026-001	ATENOLOL	100MG	TABLET / ORAL	AB	1991-09-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A073026-002	ATENOLOL	25MG	TABLET / ORAL	AB	1992-05-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A073026-003	ATENOLOL	50MG	TABLET / ORAL	AB	1991-09-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073026-001	ATENOLOL	100MG	TABLET / ORAL	AB	1991-09-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073026-002	ATENOLOL	25MG	TABLET / ORAL	AB	1992-05-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073026-003	ATENOLOL	50MG	TABLET / ORAL	AB	1991-09-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073026-001	ATENOLOL	100MG	TABLET / ORAL	AB	1991-09-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073026-002	ATENOLOL	25MG	TABLET / ORAL	AB	1992-05-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073026-003	ATENOLOL	50MG	TABLET / ORAL	AB	1991-09-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073026-001	ATENOLOL	100MG	TABLET / ORAL	AB	1991-09-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073026-002	ATENOLOL	25MG	TABLET / ORAL	AB	1992-05-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073026-003	ATENOLOL	50MG	TABLET / ORAL	AB	1991-09-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073026-001	ATENOLOL	100MG	TABLET / ORAL	AB	1991-09-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073026-002	ATENOLOL	25MG	TABLET / ORAL	AB	1992-05-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073026-003	ATENOLOL	50MG	TABLET / ORAL	AB	1991-09-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073026-001	ATENOLOL	100MG	TABLET / ORAL	AB	1991-09-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073026-002	ATENOLOL	25MG	TABLET / ORAL	AB	1992-05-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073026-003	ATENOLOL	50MG	TABLET / ORAL	AB	1991-09-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073026-001	ATENOLOL	100MG	TABLET / ORAL	AB	1991-09-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073026-002	ATENOLOL	25MG	TABLET / ORAL	AB	1992-05-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073026-003	ATENOLOL	50MG	TABLET / ORAL	AB	1991-09-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A073026-001	ATENOLOL	100MG	TABLET / ORAL	AB	1991-09-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A073026-002	ATENOLOL	25MG	TABLET / ORAL	AB	1992-05-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A073026-003	ATENOLOL	50MG	TABLET / ORAL	AB	1991-09-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073026-001	ATENOLOL	100MG	TABLET / ORAL	AB	1991-09-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073026-002	ATENOLOL	25MG	TABLET / ORAL	AB	1992-05-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073026-003	ATENOLOL	50MG	TABLET / ORAL	AB	1991-09-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073026-001	ATENOLOL	100MG	TABLET / ORAL	AB	1991-09-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073026-002	ATENOLOL	25MG	TABLET / ORAL	AB	1992-05-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073026-003	ATENOLOL	50MG	TABLET / ORAL	AB	1991-09-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073026-001	ATENOLOL	100MG	TABLET / ORAL	AB	1991-09-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073026-002	ATENOLOL	25MG	TABLET / ORAL	AB	1992-05-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073026-003	ATENOLOL	50MG	TABLET / ORAL	AB	1991-09-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A073026-001	ATENOLOL	100MG	TABLET / ORAL	AB	1991-09-17	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 115 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	A073026-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A073026-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A073026-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073026-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073026-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073026-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A073026-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A073026-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A073026-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073026-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073026-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073026-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073026-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073026-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073026-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073026-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073026-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073026-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073026-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073026-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073026-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073026-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073026-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073026-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073026-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073026-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073026-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A073026-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A073026-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A073026-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073026-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073026-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073026-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073026-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073026-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073026-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073026-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073026-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073026-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A073026-001	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Atenolol	ATENOLOL	Bryant Ranch Prepack	1ec7b937-e448-45c7-ad7a-55fd722a50a6	2024-06-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073026 application number: ANDA073026
Atenolol	ATENOLOL	Bryant Ranch Prepack	ecfcebcc-8fcd-48e6-871e-151074df3abc	2024-06-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073026 application number: ANDA073026
Atenolol	ATENOLOL	Bryant Ranch Prepack	79490e9f-bbed-4e8f-b640-7d218741303a	2024-06-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073026 application number: ANDA073026

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0781-1507	Atenolol	Atenolol	Sandoz Inc	ANDA	Current
0781-1507	Atenolol	Atenolol	Sandoz Inc	ANDA	Current
0781-5229	Atenolol	Atenolol	Sandoz Inc	ANDA	Current
49999-178	Atenolol	Atenolol	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
50090-2760	Atenolol	Atenolol	A-S Medication Solutions	ANDA	Current
67544-332	Atenolol	Atenolol	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
67544-332	Atenolol	Atenolol	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
68071-3224	Atenolol	Atenolol	NuCare Pharmaceuticals, Inc.	ANDA	Current
68788-9761	Atenolol	Atenolol	Preferred Pharmaceutials Inc.	ANDA	Current
70934-458	Atenolol	Atenolol	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-458	Atenolol	Atenolol	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71335-1379	Atenolol	Atenolol	Bryant Ranch Prepack	ANDA	Current
75834-281	Atenolol	Atenolol	Nivagen Pharmaceuticals, Inc.	ANDA	Current
75834-282	Atenolol	Atenolol	Nivagen Pharmaceuticals, Inc.	ANDA	Current
75834-283	Atenolol	Atenolol	Nivagen Pharmaceuticals, Inc.	ANDA	Current