Application 019058

Type: NDA
Sponsor: ASTRAZENECA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TENORMIN	ATENOLOL	INJECTABLE;INJECTION	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N019058-001	TENORMIN	ATENOLOL	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1989-09-13

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 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`f41ea6bd6efb…`

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 5 of 5 · 96 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Atenolol	ATENOLOL	Aurobindo Pharma Limited	1b8a4689-3916-4f4b-b54a-bbb4e322d79b	2024-02-21	Warnings, Adverse reactions	Name fallback generic name: ATENOLOL
Atenolol	ATENOLOL	Unichem Pharmaceuticals (USA), Inc.	35d99c43-7305-4a4a-886e-a9bf3ee88fa8	2024-01-18	Warnings, Adverse reactions	Name fallback generic name: ATENOLOL
Atenolol	ATENOLOL	Zydus Pharmaceuticals USA Inc.	db801706-1362-44c7-92ab-f584f96c7e1c	2024-01-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ATENOLOL
Atenolol	ATENOLOL	A-S Medication Solutions	d73a475a-c8c9-44a0-89ac-6a2d665c0d24	2023-12-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ATENOLOL
Atenolol	ATENOLOL	A-S Medication Solutions	a0e3b2a5-5ea1-4549-8144-bd059f7966f0	2023-12-03	Warnings, Adverse reactions	Name fallback generic name: ATENOLOL
Atenolol	ATENOLOL	A-S Medication Solutions	98471493-56ee-47a4-9120-0975c265361e	2023-12-03	Warnings, Adverse reactions	Name fallback generic name: ATENOLOL
TENORMIN	ATENOLOL	Almatica Pharma LLC	746db603-a6e1-4dc3-c2d8-92314419098c	2023-11-15	Warnings, Adverse reactions	Name fallback brand name: TENORMIN generic name: ATENOLOL
Atenolol	ATENOLOL	NCS HealthCare of KY, LLC dba Vangard Labs	c8cdb347-1767-4595-baff-b50987cd8c3a	2023-02-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ATENOLOL
Atenolol	ATENOLOL	Aphena Pharma Solutions - Tennessee, LLC	9aef7a49-d21f-4529-8abf-68bdc343bb6c	2022-08-24	Warnings, Adverse reactions	Name fallback generic name: ATENOLOL
Atenolol	ATENOLOL	Proficient Rx LP	0a54656e-60dd-4ffc-b01a-423af19cd618	2022-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ATENOLOL
Atenolol	ATENOLOL	Proficient Rx LP	24f1f3f4-bbda-458b-b15f-d942c90534e2	2022-06-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ATENOLOL
Atenolol	ATENOLOL	Proficient Rx LP	e115f27a-6a7c-498c-b4a1-2d4c5716af22	2020-10-01	Warnings, Adverse reactions	Name fallback generic name: ATENOLOL
Atenolol	ATENOLOL	Bryant Ranch Prepack	ba0b0221-d4b3-4cb1-9435-53a75fcc4b40	2020-07-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ATENOLOL
Atenolol	ATENOLOL	Proficient Rx LP	b198b34c-861a-4b52-b4df-8c48b807520a	2020-02-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ATENOLOL
Atenolol	ATENOLOL	Proficient Rx LP	c3a23869-1e3f-40f0-9726-833700580113	2019-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ATENOLOL
Atenolol	ATENOLOL	Aphena Pharma Solutions - Tennessee, LLC	b02b4be4-b75c-4153-b402-cf330a077439	2017-12-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ATENOLOL

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
1223	SUPPL	2005-02-11
16185	SUPPL	2003-11-13
1222	SUPPL	2003-01-22
40872	SUPPL	2001-06-04
40871	SUPPL	2001-06-04