Application 018760

Type: NDA
Sponsor: ALVOGEN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TENORETIC 100	ATENOLOL; CHLORTHALIDONE	TABLET;ORAL	100MG;25MG	Yes	Yes
002	TENORETIC 50	ATENOLOL; CHLORTHALIDONE	TABLET;ORAL	50MG;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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N018760-001	TENORETIC 100	ATENOLOL; CHLORTHALIDONE	100MG;25MG	TABLET / ORAL		RLD	1984-06-08
N018760-002	TENORETIC 50	ATENOLOL; CHLORTHALIDONE	50MG;25MG	TABLET / ORAL		RLD	1984-06-08

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 3 of 3 · 88 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
2022-10-28 04:53 UTC	2022-10	N018760-001	TENORETIC 100	100MG;25MG	TABLET / ORAL	AB	RLD, RS	1984-06-08	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N018760-002	TENORETIC 50	50MG;25MG	TABLET / ORAL	AB	RLD	1984-06-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018760-001	TENORETIC 100	100MG;25MG	TABLET / ORAL	AB	RLD, RS	1984-06-08	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N018760-002	TENORETIC 50	50MG;25MG	TABLET / ORAL	AB	RLD	1984-06-08	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N018760-001	TENORETIC 100	100MG;25MG	TABLET / ORAL	AB	RLD, RS	1984-06-08	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N018760-002	TENORETIC 50	50MG;25MG	TABLET / ORAL	AB	RLD	1984-06-08	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N018760-001	TENORETIC 100	100MG;25MG	TABLET / ORAL		RLD	1984-06-08	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N018760-002	TENORETIC 50	50MG;25MG	TABLET / ORAL		RLD	1984-06-08	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 80 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N018760-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018760-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018760-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018760-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018760-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018760-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018760-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018760-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018760-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018760-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018760-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018760-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018760-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018760-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018760-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018760-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018760-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018760-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018760-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018760-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018760-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018760-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018760-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018760-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018760-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018760-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018760-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N018760-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018760-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018760-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018760-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N018760-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018760-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N018760-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018760-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018760-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018760-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N018760-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018760-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N018760-002	AB	1	`782e0a99824c…`

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 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
52427-382	TENORETIC	Atenolol and Chlorthalidone	Almatica Pharma LLC	NDA	Current
52427-382	TENORETIC	Atenolol and Chlorthalidone	Almatica Pharma LLC	NDA	Current
52427-382	TENORETIC	Atenolol and Chlorthalidone	Almatica Pharma Inc.	NDA	Current
52427-382	TENORETIC	Atenolol and Chlorthalidone	Almatica Pharma LLC	NDA	Current
52427-382	TENORETIC	Atenolol and Chlorthalidone	Almatica Pharma Inc.	NDA	Current
52427-383	TENORETIC	Atenolol and Chlorthalidone	Almatica Pharma LLC	NDA	Current
52427-383	TENORETIC	Atenolol and Chlorthalidone	Almatica Pharma LLC	NDA	Current
52427-383	TENORETIC	Atenolol and Chlorthalidone	Almatica Pharma Inc.	NDA	Current
52427-383	TENORETIC	Atenolol and Chlorthalidone	Almatica Pharma LLC	NDA	Current
52427-383	TENORETIC	Atenolol and Chlorthalidone	Almatica Pharma Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
77160	SUPPL	2023-12-27
77132	SUPPL	2023-12-27
11318	SUPPL	2012-11-02
1063	SUPPL	2012-11-01
11317	SUPPL	2011-08-24
16032	SUPPL	2011-08-18
33592	SUPPL	2008-11-07
1062	SUPPL	2008-10-30
16031	SUPPL	2005-02-11
1061	SUPPL	2003-12-02
16030	SUPPL	2003-01-31
40825	SUPPL	2001-06-04
20155	SUPPL	2001-06-04