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 44.

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 · 132 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
2026-10-15 13:18:30	2026-09	A077443-001	ATENOLOL	25MG	TABLET / ORAL	AB	2006-09-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077443-002	ATENOLOL	50MG	TABLET / ORAL	AB	2006-09-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077443-003	ATENOLOL	100MG	TABLET / ORAL	AB	2006-09-13	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A077443-001	ATENOLOL	25MG	TABLET / ORAL	AB	2006-09-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077443-002	ATENOLOL	50MG	TABLET / ORAL	AB	2006-09-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077443-003	ATENOLOL	100MG	TABLET / ORAL	AB	2006-09-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077443-001	ATENOLOL	25MG	TABLET / ORAL	AB	2006-09-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077443-002	ATENOLOL	50MG	TABLET / ORAL	AB	2006-09-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077443-003	ATENOLOL	100MG	TABLET / ORAL	AB	2006-09-13	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A077443-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077443-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077443-003	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A077443-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077443-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077443-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077443-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077443-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077443-003	AB	1	`caaa826d4ba7…`
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…`

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 2 of 2 · 25 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Atenolol	ATENOLOL	NuCare Pharmaceuticals,Inc.	741f328d-21a1-3b19-e053-2a91aa0aa327	2024-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077443 application number: ANDA077443
Atenolol	ATENOLOL	NuCare Pharmaceuticals,Inc.	754a1ea1-1233-066f-e053-2991aa0a33a9	2024-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077443 application number: ANDA077443
Atenolol	ATENOLOL	NCS HealthCare of KY, LLC dba Vangard Labs	c8cdb347-1767-4595-baff-b50987cd8c3a	2023-02-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077443 application number: ANDA077443
Atenolol	ATENOLOL	Proficient Rx LP	0a54656e-60dd-4ffc-b01a-423af19cd618	2022-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077443 application number: ANDA077443 ndc (product): 71205-229
Atenolol	ATENOLOL	Proficient Rx LP	c3a23869-1e3f-40f0-9726-833700580113	2019-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077443 application number: ANDA077443 ndc (product): 71205-096

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 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