Application 077443

Type: ANDA
Sponsor: UNIQUE PHARM LABS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ATENOLOL	ATENOLOL	TABLET;ORAL	25MG	No	No
002	ATENOLOL	ATENOLOL	TABLET;ORAL	50MG	No	No
003	ATENOLOL	ATENOLOL	TABLET;ORAL	100MG	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
A077443-001	ATENOLOL	ATENOLOL	25MG	TABLET / ORAL	AB	2006-09-13
A077443-002	ATENOLOL	ATENOLOL	50MG	TABLET / ORAL	AB	2006-09-13
A077443-003	ATENOLOL	ATENOLOL	100MG	TABLET / ORAL	AB	2006-09-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077443-001	AB
A077443-002	AB
A077443-003	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	A077443-001	ATENOLOL	25MG	TABLET / ORAL	AB	2006-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077443-002	ATENOLOL	50MG	TABLET / ORAL	AB	2006-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077443-003	ATENOLOL	100MG	TABLET / ORAL	AB	2006-09-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077443-001	ATENOLOL	25MG	TABLET / ORAL	AB	2006-09-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077443-002	ATENOLOL	50MG	TABLET / ORAL	AB	2006-09-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077443-003	ATENOLOL	100MG	TABLET / ORAL	AB	2006-09-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077443-001	ATENOLOL	25MG	TABLET / ORAL	AB	2006-09-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077443-002	ATENOLOL	50MG	TABLET / ORAL	AB	2006-09-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077443-003	ATENOLOL	100MG	TABLET / ORAL	AB	2006-09-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077443-001	ATENOLOL	25MG	TABLET / ORAL	AB	2006-09-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077443-002	ATENOLOL	50MG	TABLET / ORAL	AB	2006-09-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077443-003	ATENOLOL	100MG	TABLET / ORAL	AB	2006-09-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077443-001	ATENOLOL	25MG	TABLET / ORAL	AB	2006-09-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077443-002	ATENOLOL	50MG	TABLET / ORAL	AB	2006-09-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077443-003	ATENOLOL	100MG	TABLET / ORAL	AB	2006-09-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077443-001	ATENOLOL	25MG	TABLET / ORAL	AB	2006-09-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077443-002	ATENOLOL	50MG	TABLET / ORAL	AB	2006-09-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077443-003	ATENOLOL	100MG	TABLET / ORAL	AB	2006-09-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077443-001	ATENOLOL	25MG	TABLET / ORAL	AB	2006-09-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077443-002	ATENOLOL	50MG	TABLET / ORAL	AB	2006-09-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077443-003	ATENOLOL	100MG	TABLET / ORAL	AB	2006-09-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077443-001	ATENOLOL	25MG	TABLET / ORAL	AB	2006-09-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077443-002	ATENOLOL	50MG	TABLET / ORAL	AB	2006-09-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077443-003	ATENOLOL	100MG	TABLET / ORAL	AB	2006-09-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077443-001	ATENOLOL	25MG	TABLET / ORAL	AB	2006-09-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077443-002	ATENOLOL	50MG	TABLET / ORAL	AB	2006-09-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077443-003	ATENOLOL	100MG	TABLET / ORAL	AB	2006-09-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077443-001	ATENOLOL	25MG	TABLET / ORAL	AB	2006-09-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077443-002	ATENOLOL	50MG	TABLET / ORAL	AB	2006-09-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077443-003	ATENOLOL	100MG	TABLET / ORAL	AB	2006-09-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077443-001	ATENOLOL	25MG	TABLET / ORAL	AB	2006-09-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077443-002	ATENOLOL	50MG	TABLET / ORAL	AB	2006-09-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077443-003	ATENOLOL	100MG	TABLET / ORAL	AB	2006-09-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077443-001	ATENOLOL	25MG	TABLET / ORAL	AB	2006-09-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077443-002	ATENOLOL	50MG	TABLET / ORAL	AB	2006-09-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077443-003	ATENOLOL	100MG	TABLET / ORAL	AB	2006-09-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077443-001	ATENOLOL	25MG	TABLET / ORAL	AB	2006-09-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077443-002	ATENOLOL	50MG	TABLET / ORAL	AB	2006-09-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077443-003	ATENOLOL	100MG	TABLET / ORAL	AB	2006-09-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077443-001	ATENOLOL	25MG	TABLET / ORAL	AB	2006-09-13	`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	A077443-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077443-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077443-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077443-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077443-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077443-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077443-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077443-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077443-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077443-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077443-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077443-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077443-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077443-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077443-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077443-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077443-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077443-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077443-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077443-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077443-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077443-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077443-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077443-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077443-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077443-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077443-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077443-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077443-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077443-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077443-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077443-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077443-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077443-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077443-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077443-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077443-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077443-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077443-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077443-001	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 2 · 25 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Atenolol	ATENOLOL	St. Mary's Medical Park Pharmacy	7f8304a4-93de-774f-e053-2a91aa0aa5b5	2026-06-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077443 application number: ANDA077443
Atenolol	ATENOLOL	St Mary's Medical Park Pharmacy	78d394b8-8ffb-a846-e053-2991aa0aa58c	2026-06-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077443 application number: ANDA077443
Atenolol	ATENOLOL	St. Mary's Medical Park Pharmacy	8501f6c1-8157-4189-e053-2a91aa0ac4ef	2026-06-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077443 application number: ANDA077443
Atenolol	ATENOLOL	Preferred Pharmaceuticals, Inc.	26d3df38-20c6-40e0-a456-da4f10fff632	2026-03-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077443 application number: ANDA077443
Atenolol	ATENOLOL	Preferred Pharmaceuticals, Inc.	a8d48a47-ccab-4a35-a092-6e562683ade3	2026-03-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077443 application number: ANDA077443
Atenolol	ATENOLOL	Preferred Pharmaceuticals Inc.	82100fc8-5a5a-4d80-8101-72024ee0abef	2026-03-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077443 application number: ANDA077443
atenolol	ATENOLOL	direct rx	b3c757de-1cbf-61f5-e053-2995a90accfc	2026-03-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077443 application number: ANDA077443 ndc (product): 72189-152
Atenolol	ATENOLOL	A-S Medication Solutions	43acd912-f0f4-47eb-b81f-cbbfed77c557	2026-01-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077443 application number: ANDA077443
Atenolol	ATENOLOL	A-S Medication Solutions	e4ece8f4-3714-42ba-b36d-d00586dfd33a	2026-01-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077443 application number: ANDA077443
Atenolol	ATENOLOL	Northwind Health Company, LLC	db5bd8e2-1314-0f7f-e053-2995a90ae86e	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077443 application number: ANDA077443
Atenolol	ATENOLOL	QPharma, Inc.	bd43e0b1-c05e-01ae-e053-2a95a90af1cd	2025-12-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077443 application number: ANDA077443
Atenolol	ATENOLOL	Rising Pharma Holdings, Inc.	96dd038f-b363-4e24-9c67-82b7c85c3bc4	2025-05-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077443 application number: ANDA077443
Atenolol	ATENOLOL	NuCare Pharmaceuticals,Inc.	8115a2bc-69aa-60b4-e053-2a91aa0aeae7	2025-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077443 application number: ANDA077443
Atenolol	ATENOLOL	Direct_Rx	ee143f2f-be60-bc67-e053-2a95a90ae6e6	2025-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077443 application number: ANDA077443 ndc (product): 72189-396
ATENOLOL	ATENOLOL	direct rx	b3d9f826-7ed7-1e3b-e053-2995a90ae731	2025-01-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077443 application number: ANDA077443 ndc (product): 72189-135
Atenolol	ATENOLOL	NuCare Pharmaceuticals,Inc.	9db36b04-f353-55d6-e053-2a95a90ae08f	2025-01-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077443 application number: ANDA077443
Atenolol	ATENOLOL	Bryant Ranch Prepack	722d6532-20d0-4936-ae9c-b7bb593b960a	2024-08-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077443 application number: ANDA077443 ndc (product): 71335-0954
Atenolol	ATENOLOL	Bryant Ranch Prepack	c7a8830a-5eda-4f0e-bf03-61ee8ed6558d	2024-08-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077443 application number: ANDA077443 ndc (product): 71335-1535
Atenolol	ATENOLOL	Bryant Ranch Prepack	1d6ea66b-30ef-4829-b757-5ea9d412a666	2024-07-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077443 application number: ANDA077443 ndc (product): 71335-1264
Atenolol	ATENOLOL	NuCare Pharmaceuticals,Inc.	73671d55-3e10-cb1d-e053-2991aa0ac038	2024-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077443 application number: ANDA077443

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 106 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70934-177	Atenolol	Atenolol	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current
70934-219	Atenolol	Atenolol	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-219	Atenolol	Atenolol	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-219	Atenolol	Atenolol	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-537	Atenolol	Atenolol	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71205-096	Atenolol	Atenolol	Proficient Rx LP	ANDA	Current
71205-096	Atenolol	Atenolol	Proficient Rx LP	ANDA	Current
71205-229	Atenolol	Atenolol	Proficient Rx LP	ANDA	Current
71205-229	Atenolol	Atenolol	Proficient Rx LP	ANDA	Current
71205-229	Atenolol	Atenolol	Proficient Rx LP	ANDA	Current
71205-229	Atenolol	Atenolol	Proficient Rx LP	ANDA	Current
71335-0954	Atenolol	Atenolol	Bryant Ranch Prepack	ANDA	Current
71335-0954	Atenolol	Atenolol	Bryant Ranch Prepack	ANDA	Current
71335-0954	Atenolol	Atenolol	Bryant Ranch Prepack	ANDA	Current
71335-1264	Atenolol	Atenolol	Bryant Ranch Prepack	ANDA	Current
71335-1264	Atenolol	Atenolol	Bryant Ranch Prepack	ANDA	Current
71335-1264	Atenolol	Atenolol	Bryant Ranch Prepack	ANDA	Current
71335-1535	Atenolol	Atenolol	Bryant Ranch Prepack	ANDA	Current
71335-1535	Atenolol	Atenolol	Bryant Ranch Prepack	ANDA	Current
71335-1535	Atenolol	Atenolol	Bryant Ranch Prepack	ANDA	Current
72189-135	ATENOLOL	ATENOLOL	direct rx	ANDA	Current
72189-135	ATENOLOL	ATENOLOL	direct rx	ANDA	Current
72189-135	ATENOLOL	ATENOLOL	direct rx	ANDA	Current
72189-135	ATENOLOL	ATENOLOL	direct rx	ANDA	Current
72189-152	atenolol	atenolol	direct rx	ANDA	Current
72189-396	Tenormin	Atenolol	Direct_Rx	ANDA	Current