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 3 of 5 · 96 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Atenolol	ATENOLOL	PD-Rx Pharmaceuticals, Inc.	95761173-1c95-46b2-a08f-fbc3e70daba8	2025-10-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Atenolol generic name: ATENOLOL
Atenolol	ATENOLOL	PD-Rx Pharmaceuticals, Inc.	8acdb229-928b-4c22-88f1-f4dd97cde274	2025-10-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Atenolol generic name: ATENOLOL
Atenolol	ATENOLOL	PD-Rx Pharmaceuticals, Inc.	c69b8e5e-c7c3-4883-9cea-f7f435a8ede8	2025-10-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Atenolol generic name: ATENOLOL
Atenolol	ATENOLOL	Bryant Ranch Prepack	290f4de3-8815-466c-81dc-8bc632375896	2025-10-13	Warnings, Adverse reactions	Name fallback brand name: Atenolol generic name: ATENOLOL
Atenolol	ATENOLOL	PD-Rx Pharmaceuticals, Inc.	bdbf6779-8e9b-4ce1-a361-ede4914dd2f3	2025-10-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Atenolol generic name: ATENOLOL
TENORMIN	ATENOLOL	Upsher-Smith Laboratories, LLC	6e850b1e-28a4-4ff8-8ed7-bb0b29faa28a	2025-09-18	Warnings, Adverse reactions	Name fallback generic name: ATENOLOL
Atenolol	ATENOLOL	Mylan Institutional Inc.	8dd93a47-d14c-49be-9c22-97c0cdbec75a	2025-07-18	Warnings, Adverse reactions	Name fallback brand name: Atenolol generic name: ATENOLOL
Atenolol	ATENOLOL	A-S Medication Solutions	3d35592c-91ac-44f6-b077-5963e952f0dd	2025-07-16	Warnings, Adverse reactions	Name fallback brand name: Atenolol generic name: ATENOLOL
Atenolol	ATENOLOL	A-S Medication Solutions	f419c72e-f1f9-4b5a-94ff-a525367cdce4	2025-07-16	Warnings, Adverse reactions	Name fallback brand name: Atenolol generic name: ATENOLOL
Atenolol	ATENOLOL	A-S Medication Solutions	d3e72119-e3c3-41ba-8787-acc86b44d6c4	2025-05-29	Warnings, Adverse reactions	Name fallback brand name: Atenolol generic name: ATENOLOL
Atenolol	ATENOLOL	A-S Medication Solutions	a3c8d507-e040-409e-9f97-742925cc66a1	2025-05-29	Warnings, Adverse reactions	Name fallback brand name: Atenolol generic name: ATENOLOL
Atenolol	ATENOLOL	Rising Pharma Holdings, Inc.	96dd038f-b363-4e24-9c67-82b7c85c3bc4	2025-05-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Atenolol generic name: ATENOLOL
Atenolol	ATENOLOL	Preferred Pharmaceuticals Inc.	0f744371-94fa-419d-bfed-b22301dde8b8	2025-02-21	Warnings, Adverse reactions	Name fallback brand name: Atenolol generic name: ATENOLOL
Atenolol	ATENOLOL	NuCare Pharmaceuticals,Inc.	8115a2bc-69aa-60b4-e053-2a91aa0aeae7	2025-02-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Atenolol generic name: ATENOLOL
Atenolol	ATENOLOL	Major Pharmaceuticals	4555261d-a997-4aa5-aba8-81aac7033787	2025-02-03	Warnings, Adverse reactions	Name fallback brand name: Atenolol generic name: ATENOLOL
Atenolol	ATENOLOL	Direct_Rx	ee143f2f-be60-bc67-e053-2a95a90ae6e6	2025-01-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Atenolol generic name: ATENOLOL
ATENOLOL	ATENOLOL	direct rx	b3d9f826-7ed7-1e3b-e053-2995a90ae731	2025-01-17	Warnings, Adverse reactions	Name fallback brand name: ATENOLOL generic name: ATENOLOL
Atenolol	ATENOLOL	NuCare Pharmaceuticals,Inc.	9db36b04-f353-55d6-e053-2a95a90ae08f	2025-01-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Atenolol generic name: ATENOLOL
Atenolol 29300-411	ATENOLOL	NuCare Pharmaceuticals,Inc.	239b1cce-3b1a-f049-e063-6394a90a0e0a	2024-12-26	Warnings, Adverse reactions	Name fallback generic name: ATENOLOL
Atenolol	ATENOLOL	American Health Packaging	d19e9fcf-dfa1-43d7-94dc-e3f03fb90f5c	2024-12-20	Boxed warning, 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.