Application 018240

Type: NDA
Sponsor: ALVOGEN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TENORMIN	ATENOLOL	TABLET;ORAL	50MG	Yes	No
002	TENORMIN	ATENOLOL	TABLET;ORAL	100MG	Yes	Yes
004	TENORMIN	ATENOLOL	TABLET;ORAL	25MG	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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	TE codes	RLD / RS	Approval date
N018240-001	TENORMIN	ATENOLOL	50MG	TABLET / ORAL	AB	RLD, Approved before 1982
N018240-002	TENORMIN	ATENOLOL	100MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982
N018240-004	TENORMIN	ATENOLOL	25MG	TABLET / ORAL	AB	RLD	1990-04-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N018240-001	AB
N018240-002	AB
N018240-004	AB

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 2 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018240-002	TENORMIN	100MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018240-004	TENORMIN	25MG	TABLET / ORAL	AB	RLD	1990-04-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018240-001	TENORMIN	50MG	TABLET / ORAL	AB	RLD, Approved before 1982		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018240-002	TENORMIN	100MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018240-004	TENORMIN	25MG	TABLET / ORAL	AB	RLD	1990-04-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018240-001	TENORMIN	50MG	TABLET / ORAL	AB	RLD, Approved before 1982		`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018240-002	TENORMIN	100MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018240-004	TENORMIN	25MG	TABLET / ORAL	AB	RLD	1990-04-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018240-001	TENORMIN	50MG	TABLET / ORAL	AB	RLD, Approved before 1982		`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N018240-002	TENORMIN	100MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N018240-004	TENORMIN	25MG	TABLET / ORAL	AB	RLD	1990-04-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018240-001	TENORMIN	50MG	TABLET / ORAL	AB	RLD, Approved before 1982		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018240-002	TENORMIN	100MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018240-004	TENORMIN	25MG	TABLET / ORAL	AB	RLD	1990-04-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018240-001	TENORMIN	50MG	TABLET / ORAL	AB	RLD, Approved before 1982		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N018240-002	TENORMIN	100MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N018240-004	TENORMIN	25MG	TABLET / ORAL	AB	RLD	1990-04-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018240-001	TENORMIN	50MG	TABLET / ORAL	AB	RLD, Approved before 1982		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N018240-002	TENORMIN	100MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N018240-004	TENORMIN	25MG	TABLET / ORAL	AB	RLD	1990-04-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018240-001	TENORMIN	50MG	TABLET / ORAL	AB	RLD, Approved before 1982		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018240-002	TENORMIN	100MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018240-004	TENORMIN	25MG	TABLET / ORAL	AB	RLD	1990-04-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018240-001	TENORMIN	50MG	TABLET / ORAL	AB	RLD, Approved before 1982		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N018240-002	TENORMIN	100MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N018240-004	TENORMIN	25MG	TABLET / ORAL	AB	RLD	1990-04-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018240-001	TENORMIN	50MG	TABLET / ORAL	AB	RLD, Approved before 1982		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N018240-002	TENORMIN	100MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N018240-004	TENORMIN	25MG	TABLET / ORAL	AB	RLD	1990-04-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018240-001	TENORMIN	50MG	TABLET / ORAL	AB	RLD, Approved before 1982		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018240-002	TENORMIN	100MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018240-004	TENORMIN	25MG	TABLET / ORAL	AB	RLD	1990-04-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018240-001	TENORMIN	50MG	TABLET / ORAL	AB	RLD, Approved before 1982		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N018240-002	TENORMIN	100MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N018240-004	TENORMIN	25MG	TABLET / ORAL	AB	RLD	1990-04-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018240-001	TENORMIN	50MG	TABLET / ORAL	AB	RLD, Approved before 1982		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N018240-002	TENORMIN	100MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N018240-004	TENORMIN	25MG	TABLET / ORAL	AB	RLD	1990-04-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018240-001	TENORMIN	50MG	TABLET / ORAL	AB	RLD, Approved before 1982		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N018240-002	TENORMIN	100MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`c0c555d07b60…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N018240-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N018240-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N018240-004	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N018240-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018240-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018240-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N018240-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018240-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018240-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018240-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018240-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018240-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018240-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018240-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018240-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018240-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018240-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018240-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018240-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018240-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018240-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018240-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018240-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018240-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018240-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018240-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018240-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018240-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018240-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018240-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018240-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018240-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018240-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018240-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018240-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018240-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018240-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018240-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018240-004	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018240-001	AB	1	`79d66fd596c7…`

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TENORMIN	ATENOLOL	Upsher-Smith Laboratories, LLC	6e850b1e-28a4-4ff8-8ed7-bb0b29faa28a	2025-09-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018240 application number: NDA018240

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
52427-429	TENORMIN	Atenolol	Almatica Pharma LLC	NDA	Current
52427-429	TENORMIN	Atenolol	Almatica Pharma LLC	NDA	Current
52427-429	TENORMIN	Atenolol	Almatica Pharma LLC	NDA	Current
52427-429	TENORMIN	Atenolol	Almatica Pharma Inc.	NDA	Current
52427-429	TENORMIN	Atenolol	Almatica Pharma Inc.	NDA	Current
52427-430	TENORMIN	Atenolol	Almatica Pharma LLC	NDA	Current
52427-430	TENORMIN	Atenolol	Almatica Pharma LLC	NDA	Current
52427-430	TENORMIN	Atenolol	Almatica Pharma LLC	NDA	Current
52427-430	TENORMIN	Atenolol	Almatica Pharma Inc.	NDA	Current
52427-430	TENORMIN	Atenolol	Almatica Pharma Inc.	NDA	Current
52427-431	TENORMIN	Atenolol	Almatica Pharma LLC	NDA	Current
52427-431	TENORMIN	Atenolol	Almatica Pharma LLC	NDA	Current
52427-431	TENORMIN	Atenolol	Almatica Pharma LLC	NDA	Current
52427-431	TENORMIN	Atenolol	Almatica Pharma Inc.	NDA	Current
52427-431	TENORMIN	Atenolol	Almatica Pharma Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
77161	SUPPL	2023-12-27
77130	SUPPL	2023-12-27
33463	SUPPL	2012-11-06
14957	SUPPL	2012-11-05
11187	SUPPL	2011-08-24
882	SUPPL	2011-08-18
14956	SUPPL	2008-05-05
881	SUPPL	2005-02-11
14955	SUPPL	2003-11-13
14954	SUPPL	2003-01-09
40788	SUPPL	2001-06-04
20117	SUPPL	2001-06-04