Application 074101

Type: ANDA
Sponsor: PLIVA

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 43.

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	Approval date
A074101-001	ATENOLOL	ATENOLOL	25MG	TABLET / ORAL	1997-07-17
A074101-002	ATENOLOL	ATENOLOL	50MG	TABLET / ORAL	1997-07-17
A074101-003	ATENOLOL	ATENOLOL	100MG	TABLET / ORAL	1997-07-17

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 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A074101-001	ATENOLOL	25MG	TABLET / ORAL	1997-07-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074101-002	ATENOLOL	50MG	TABLET / ORAL	1997-07-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074101-003	ATENOLOL	100MG	TABLET / ORAL	1997-07-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074101-001	ATENOLOL	25MG	TABLET / ORAL	1997-07-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074101-002	ATENOLOL	50MG	TABLET / ORAL	1997-07-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074101-003	ATENOLOL	100MG	TABLET / ORAL	1997-07-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074101-001	ATENOLOL	25MG	TABLET / ORAL	1997-07-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074101-002	ATENOLOL	50MG	TABLET / ORAL	1997-07-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074101-003	ATENOLOL	100MG	TABLET / ORAL	1997-07-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074101-001	ATENOLOL	25MG	TABLET / ORAL	1997-07-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074101-002	ATENOLOL	50MG	TABLET / ORAL	1997-07-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074101-003	ATENOLOL	100MG	TABLET / ORAL	1997-07-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074101-001	ATENOLOL	25MG	TABLET / ORAL	1997-07-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074101-002	ATENOLOL	50MG	TABLET / ORAL	1997-07-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074101-003	ATENOLOL	100MG	TABLET / ORAL	1997-07-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074101-001	ATENOLOL	25MG	TABLET / ORAL	1997-07-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074101-002	ATENOLOL	50MG	TABLET / ORAL	1997-07-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074101-003	ATENOLOL	100MG	TABLET / ORAL	1997-07-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074101-001	ATENOLOL	25MG	TABLET / ORAL	1997-07-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074101-002	ATENOLOL	50MG	TABLET / ORAL	1997-07-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074101-003	ATENOLOL	100MG	TABLET / ORAL	1997-07-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074101-001	ATENOLOL	25MG	TABLET / ORAL	1997-07-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074101-002	ATENOLOL	50MG	TABLET / ORAL	1997-07-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074101-003	ATENOLOL	100MG	TABLET / ORAL	1997-07-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074101-001	ATENOLOL	25MG	TABLET / ORAL	1997-07-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074101-002	ATENOLOL	50MG	TABLET / ORAL	1997-07-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074101-003	ATENOLOL	100MG	TABLET / ORAL	1997-07-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074101-001	ATENOLOL	25MG	TABLET / ORAL	1997-07-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074101-002	ATENOLOL	50MG	TABLET / ORAL	1997-07-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074101-003	ATENOLOL	100MG	TABLET / ORAL	1997-07-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074101-001	ATENOLOL	25MG	TABLET / ORAL	1997-07-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074101-002	ATENOLOL	50MG	TABLET / ORAL	1997-07-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074101-003	ATENOLOL	100MG	TABLET / ORAL	1997-07-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074101-001	ATENOLOL	25MG	TABLET / ORAL	1997-07-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074101-002	ATENOLOL	50MG	TABLET / ORAL	1997-07-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074101-003	ATENOLOL	100MG	TABLET / ORAL	1997-07-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074101-001	ATENOLOL	25MG	TABLET / ORAL	1997-07-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074101-002	ATENOLOL	50MG	TABLET / ORAL	1997-07-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074101-003	ATENOLOL	100MG	TABLET / ORAL	1997-07-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074101-001	ATENOLOL	25MG	TABLET / ORAL	1997-07-17	`301d65b070ca…`

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 4 of 5 · 96 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Atenolol	ATENOLOL	Quality Care Products, LLC	4fc4a969-286f-4fd2-b16a-f0291fd1c5c0	2024-12-19	Warnings, Adverse reactions	Name fallback brand name: Atenolol generic name: ATENOLOL
Atenolol	ATENOLOL	Bryant Ranch Prepack	09b21985-1818-449d-9b29-98f733cf7b9f	2024-11-26	Warnings, Adverse reactions	Name fallback brand name: Atenolol generic name: ATENOLOL
Atenolol	ATENOLOL	Zydus Lifesciences Limited	2492d5f6-00b0-42c9-a793-2be83ea81ad1	2024-11-25		Name fallback brand name: Atenolol generic name: ATENOLOL
Atenolol	ATENOLOL	NuCare Pharmaceuticals, Inc.	3d70576a-6fa7-481d-e054-00144ff88e88	2024-11-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Atenolol generic name: ATENOLOL
Atenolol	ATENOLOL	Preferred Pharmaceuticals Inc.	2ae158bb-aa03-4b44-916b-1fcfc84b4fd0	2024-11-06	Warnings, Adverse reactions	Name fallback brand name: Atenolol generic name: ATENOLOL
Atenolol	ATENOLOL	Aphena Pharma Solutions - Tennessee, LLC	23e96396-85d3-0d8e-e063-6394a90a614d	2024-10-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Atenolol generic name: ATENOLOL
Atenolol	ATENOLOL	Aphena Pharma Solutions - Tennessee, LLC	247569d6-9a73-f1d0-e063-6394a90a667a	2024-10-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Atenolol generic name: ATENOLOL
Atenolol	ATENOLOL	Bryant Ranch Prepack	67d9ca94-2af6-4ebb-a5c3-8d360f741277	2024-09-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Atenolol generic name: ATENOLOL
Atenolol	ATENOLOL	Bryant Ranch Prepack	722d6532-20d0-4936-ae9c-b7bb593b960a	2024-08-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Atenolol generic name: ATENOLOL
Atenolol	ATENOLOL	Bryant Ranch Prepack	c7a8830a-5eda-4f0e-bf03-61ee8ed6558d	2024-08-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Atenolol generic name: ATENOLOL
Atenolol	ATENOLOL	Bryant Ranch Prepack	1d6ea66b-30ef-4829-b757-5ea9d412a666	2024-07-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Atenolol generic name: ATENOLOL
Atenolol	ATENOLOL	NuCare Pharmaceuticals,Inc.	7366c6f8-4cb3-520e-e053-2991aa0a2cc8	2024-06-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Atenolol generic name: ATENOLOL
Atenolol	ATENOLOL	NuCare Pharmaceuticals,Inc.	73671d55-3e10-cb1d-e053-2991aa0ac038	2024-06-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Atenolol generic name: ATENOLOL
Atenolol	ATENOLOL	NuCare Pharmaceuticals,Inc.	741f328d-21a1-3b19-e053-2a91aa0aa327	2024-06-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Atenolol generic name: ATENOLOL
Atenolol	ATENOLOL	NuCare Pharmaceuticals,Inc.	754a1ea1-1233-066f-e053-2991aa0a33a9	2024-06-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Atenolol generic name: ATENOLOL
Atenolol	ATENOLOL	Bryant Ranch Prepack	1ec7b937-e448-45c7-ad7a-55fd722a50a6	2024-06-05	Warnings, Adverse reactions	Name fallback brand name: Atenolol generic name: ATENOLOL
Atenolol	ATENOLOL	Bryant Ranch Prepack	ecfcebcc-8fcd-48e6-871e-151074df3abc	2024-06-05	Warnings, Adverse reactions	Name fallback brand name: Atenolol generic name: ATENOLOL
Atenolol	ATENOLOL	Bryant Ranch Prepack	79490e9f-bbed-4e8f-b640-7d218741303a	2024-06-05	Warnings, Adverse reactions	Name fallback brand name: Atenolol generic name: ATENOLOL
Atenolol	ATENOLOL	Teva Pharmaceuticals USA, Inc.	25a72ec9-de0f-44e5-90b8-da1aab0d3588	2024-05-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Atenolol generic name: ATENOLOL
Atenolol	ATENOLOL	Bryant Ranch Prepack	bd0f7f1c-dd20-4de6-a012-f581a216f23f	2024-04-03	Warnings, Adverse reactions	Name fallback brand name: Atenolol generic name: ATENOLOL

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.