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001	TENORMIN	ATENOLOL	INJECTABLE;INJECTION	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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N019058-001	TENORMIN	ATENOLOL	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1989-09-13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N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`84e616aacf4f…`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N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`caaa826d4ba7…`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UTC	2026-02	N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`011fe1cb6892…`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of this ZIP	2025-12	N019058-001	TENORMIN	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1989-09-13	`31067a03dcf5…`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 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 generic name: ATENOLOL
Atenolol	ATENOLOL	Bryant Ranch Prepack	09b21985-1818-449d-9b29-98f733cf7b9f	2024-11-26	Warnings, Adverse reactions	Name fallback generic name: ATENOLOL
Atenolol	ATENOLOL	Zydus Lifesciences Limited	2492d5f6-00b0-42c9-a793-2be83ea81ad1	2024-11-25		Name fallback generic name: ATENOLOL
Atenolol	ATENOLOL	NuCare Pharmaceuticals, Inc.	3d70576a-6fa7-481d-e054-00144ff88e88	2024-11-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ATENOLOL
Atenolol	ATENOLOL	Preferred Pharmaceuticals Inc.	2ae158bb-aa03-4b44-916b-1fcfc84b4fd0	2024-11-06	Warnings, Adverse reactions	Name fallback 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 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 generic name: ATENOLOL
Atenolol	ATENOLOL	Bryant Ranch Prepack	67d9ca94-2af6-4ebb-a5c3-8d360f741277	2024-09-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ATENOLOL
Atenolol	ATENOLOL	Bryant Ranch Prepack	722d6532-20d0-4936-ae9c-b7bb593b960a	2024-08-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ATENOLOL
Atenolol	ATENOLOL	Bryant Ranch Prepack	c7a8830a-5eda-4f0e-bf03-61ee8ed6558d	2024-08-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ATENOLOL
Atenolol	ATENOLOL	Bryant Ranch Prepack	1d6ea66b-30ef-4829-b757-5ea9d412a666	2024-07-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ATENOLOL
Atenolol	ATENOLOL	NuCare Pharmaceuticals,Inc.	7366c6f8-4cb3-520e-e053-2991aa0a2cc8	2024-06-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ATENOLOL
Atenolol	ATENOLOL	NuCare Pharmaceuticals,Inc.	73671d55-3e10-cb1d-e053-2991aa0ac038	2024-06-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ATENOLOL
Atenolol	ATENOLOL	NuCare Pharmaceuticals,Inc.	741f328d-21a1-3b19-e053-2a91aa0aa327	2024-06-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ATENOLOL
Atenolol	ATENOLOL	NuCare Pharmaceuticals,Inc.	754a1ea1-1233-066f-e053-2991aa0a33a9	2024-06-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ATENOLOL
Atenolol	ATENOLOL	Bryant Ranch Prepack	1ec7b937-e448-45c7-ad7a-55fd722a50a6	2024-06-05	Warnings, Adverse reactions	Name fallback generic name: ATENOLOL
Atenolol	ATENOLOL	Bryant Ranch Prepack	ecfcebcc-8fcd-48e6-871e-151074df3abc	2024-06-05	Warnings, Adverse reactions	Name fallback generic name: ATENOLOL
Atenolol	ATENOLOL	Bryant Ranch Prepack	79490e9f-bbed-4e8f-b640-7d218741303a	2024-06-05	Warnings, Adverse reactions	Name fallback generic name: ATENOLOL
Atenolol	ATENOLOL	Teva Pharmaceuticals USA, Inc.	25a72ec9-de0f-44e5-90b8-da1aab0d3588	2024-05-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ATENOLOL
Atenolol	ATENOLOL	Bryant Ranch Prepack	bd0f7f1c-dd20-4de6-a012-f581a216f23f	2024-04-03	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