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001	TENORMIN	ATENOLOL	INJECTABLE;INJECTION	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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N019058-001	TENORMIN	ATENOLOL	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1989-09-13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N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`84e616aacf4f…`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N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`caaa826d4ba7…`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UTC	2026-02	N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`011fe1cb6892…`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of this ZIP	2025-12	N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`31067a03dcf5…`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 1 of 5 · 96 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Atenolol	ATENOLOL	REMEDYREPACK INC.	897e18f6-3b57-4ef0-85ff-9dfa23521eb9	2026-09-03	Warnings, Adverse reactions	Name fallback generic name: ATENOLOL
Atenolol	ATENOLOL	REMEDYREPACK INC.	cdca0ef8-2ac3-4430-a662-f88522f68d8e	2026-08-27	Warnings, Adverse reactions	Name fallback generic name: ATENOLOL
Atenolol	ATENOLOL	St. Mary's Medical Park Pharmacy	59f418e6-47db-6a71-e063-6294a90a632c	2026-08-25	Warnings, Adverse reactions	Name fallback generic name: ATENOLOL
Atenolol	ATENOLOL	Cardinal Health 107, LLC	15c0c2df-f195-45f9-a1e4-1ed2a43c2216	2026-08-07	Warnings, Adverse reactions	Name fallback generic name: ATENOLOL
Atenolol	ATENOLOL	REMEDYREPACK INC.	4ca8dd77-cdac-41fe-a742-b1b32551203b	2026-07-31	Warnings, Adverse reactions	Name fallback generic name: ATENOLOL
Atenolol	ATENOLOL	Cardinal Health 107, LLC	0fadc652-b075-46ec-ae05-beaf7d91ae13	2026-07-20	Warnings, Adverse reactions	Name fallback generic name: ATENOLOL
Atenolol	ATENOLOL	Safecor Health, LLC	35d04cfd-34d4-429c-b990-a6c00137bc77	2026-07-10	Warnings, Adverse reactions	Name fallback generic name: ATENOLOL
Atenolol	ATENOLOL	St. Mary's Medical Park Pharmacy	7f8304a4-93de-774f-e053-2a91aa0aa5b5	2026-06-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ATENOLOL
Atenolol	ATENOLOL	Golden State Medical Supply, Inc.	f4f06c00-9024-4e04-a882-0da2b24d8ff7	2026-06-17	Warnings, Adverse reactions	Name fallback generic name: ATENOLOL
Atenolol	ATENOLOL	St Mary's Medical Park Pharmacy	78d394b8-8ffb-a846-e053-2991aa0aa58c	2026-06-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ATENOLOL
Atenolol	ATENOLOL	St. Mary's Medical Park Pharmacy	8501f6c1-8157-4189-e053-2a91aa0ac4ef	2026-06-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ATENOLOL
Atenolol	ATENOLOL	ASCLEMED USA INC.	2ee7b7da-303d-4a57-a1eb-25e8923660c0	2026-05-19	Warnings, Adverse reactions	Name fallback generic name: ATENOLOL
Atenolol	ATENOLOL	Coupler LLC	5126a70e-632d-e626-e063-6394a90ab791	2026-05-06	Warnings, Adverse reactions	Name fallback generic name: ATENOLOL
Atenolol	ATENOLOL	Coupler LLC	50760735-9305-0bbf-e063-6294a90a5b4c	2026-04-27	Warnings, Adverse reactions	Name fallback generic name: ATENOLOL
Atenolol	ATENOLOL	Coupler LLC	50762eee-e139-4d7f-e063-6294a90a777c	2026-04-27	Warnings, Adverse reactions	Name fallback generic name: ATENOLOL
Atenolol	ATENOLOL	Preferred Pharmaceuticals Inc.	0ad0c7dd-e4e5-4968-9372-7a9bb30073ec	2026-04-22	Warnings, Adverse reactions	Name fallback generic name: ATENOLOL
Atenolol	ATENOLOL	REMEDYREPACK INC.	f5c86a73-70b6-46b2-ad9a-272c8d4673e9	2026-04-13	Warnings, Adverse reactions	Name fallback generic name: ATENOLOL
Atenolol	ATENOLOL	Preferred Pharmaceuticals Inc.	5ad1426a-5a74-427b-812d-c7b144c84474	2026-03-10	Warnings, Adverse reactions	Name fallback generic name: ATENOLOL
Atenolol	ATENOLOL	Preferred Pharmaceuticals, Inc.	26d3df38-20c6-40e0-a456-da4f10fff632	2026-03-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ATENOLOL
Atenolol	ATENOLOL	Preferred Pharmaceuticals, Inc.	a8d48a47-ccab-4a35-a092-6e562683ade3	2026-03-10	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