Application 020665

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DIOVAN	VALSARTAN	CAPSULE;ORAL	80MG	No	No
002	DIOVAN	VALSARTAN	CAPSULE;ORAL	160MG	No	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
N020665-001	DIOVAN	VALSARTAN	80MG	CAPSULE / ORAL			1996-12-23
N020665-002	DIOVAN	VALSARTAN	160MG	CAPSULE / ORAL			1996-12-23

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 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N020665-001	DIOVAN	80MG	CAPSULE / ORAL	1996-12-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020665-002	DIOVAN	160MG	CAPSULE / ORAL	1996-12-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020665-001	DIOVAN	80MG	CAPSULE / ORAL	1996-12-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020665-002	DIOVAN	160MG	CAPSULE / ORAL	1996-12-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020665-001	DIOVAN	80MG	CAPSULE / ORAL	1996-12-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020665-002	DIOVAN	160MG	CAPSULE / ORAL	1996-12-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020665-001	DIOVAN	80MG	CAPSULE / ORAL	1996-12-23	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020665-002	DIOVAN	160MG	CAPSULE / ORAL	1996-12-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020665-001	DIOVAN	80MG	CAPSULE / ORAL	1996-12-23	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020665-002	DIOVAN	160MG	CAPSULE / ORAL	1996-12-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020665-001	DIOVAN	80MG	CAPSULE / ORAL	1996-12-23	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020665-002	DIOVAN	160MG	CAPSULE / ORAL	1996-12-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020665-001	DIOVAN	80MG	CAPSULE / ORAL	1996-12-23	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020665-002	DIOVAN	160MG	CAPSULE / ORAL	1996-12-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020665-001	DIOVAN	80MG	CAPSULE / ORAL	1996-12-23	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020665-002	DIOVAN	160MG	CAPSULE / ORAL	1996-12-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020665-001	DIOVAN	80MG	CAPSULE / ORAL	1996-12-23	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020665-002	DIOVAN	160MG	CAPSULE / ORAL	1996-12-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020665-001	DIOVAN	80MG	CAPSULE / ORAL	1996-12-23	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020665-002	DIOVAN	160MG	CAPSULE / ORAL	1996-12-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020665-001	DIOVAN	80MG	CAPSULE / ORAL	1996-12-23	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020665-002	DIOVAN	160MG	CAPSULE / ORAL	1996-12-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020665-001	DIOVAN	80MG	CAPSULE / ORAL	1996-12-23	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N020665-002	DIOVAN	160MG	CAPSULE / ORAL	1996-12-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020665-001	DIOVAN	80MG	CAPSULE / ORAL	1996-12-23	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N020665-002	DIOVAN	160MG	CAPSULE / ORAL	1996-12-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020665-001	DIOVAN	80MG	CAPSULE / ORAL	1996-12-23	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020665-002	DIOVAN	160MG	CAPSULE / ORAL	1996-12-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020665-001	DIOVAN	80MG	CAPSULE / ORAL	1996-12-23	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020665-002	DIOVAN	160MG	CAPSULE / ORAL	1996-12-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020665-001	DIOVAN	80MG	CAPSULE / ORAL	1996-12-23	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020665-002	DIOVAN	160MG	CAPSULE / ORAL	1996-12-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020665-001	DIOVAN	80MG	CAPSULE / ORAL	1996-12-23	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020665-002	DIOVAN	160MG	CAPSULE / ORAL	1996-12-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020665-001	DIOVAN	80MG	CAPSULE / ORAL	1996-12-23	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N020665-002	DIOVAN	160MG	CAPSULE / ORAL	1996-12-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020665-001	DIOVAN	80MG	CAPSULE / ORAL	1996-12-23	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N020665-002	DIOVAN	160MG	CAPSULE / ORAL	1996-12-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020665-001	DIOVAN	80MG	CAPSULE / ORAL	1996-12-23	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020665-002	DIOVAN	160MG	CAPSULE / ORAL	1996-12-23	`3a93d1ddd44b…`

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 4 · 61 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Valsartan	VALSARTAN	Aphena Pharma Solutions - Tennessee, LLC	5a816ea6-2645-bd6e-e063-6294a90a908b	2026-09-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALSARTAN
valsartan	VALSARTAN	Jubilant Cadista Pharmaceuticals Inc.	9402b022-5809-4251-dfef-54f6ef5723fe	2026-08-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALSARTAN
Valsartan	VALSARTAN	Aphena Pharma Solutions - Tennessee, LLC	59d3db05-2d63-9dbf-e063-6394a90a8dd3	2026-08-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALSARTAN
Diovan	VALSARTAN	Novartis Pharmaceuticals Corporation	5ddba454-f3e6-43c2-a7a6-58365d297213	2026-08-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diovan generic name: VALSARTAN
VALSARTAN	VALSARTAN	Ohm Laboratories Inc.	ab5e0e5a-5bdf-4cfc-9d18-57ea4d642f65	2026-08-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALSARTAN
Valsartan	VALSARTAN	Macleods Pharmaceuticals Limited	251ccff4-bf86-453b-9d1c-e3c1ecfd3a46	2026-08-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALSARTAN
Valsartan	VALSARTAN	Bryant Ranch Prepack	7aaa0a16-d7c6-4952-aa27-0b4b8982dc5f	2026-08-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALSARTAN
Valsartan	VALSARTAN	ScieGen Pharmaceuticals, INC.	1a8af3d9-4053-4233-82a7-e8c7bc9e302f	2026-07-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALSARTAN
Valsartan	VALSARTAN	A-S Medication Solutions	bb3c66a7-d397-4df5-822f-4a1f797f54fc	2026-07-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALSARTAN
Valsartan	VALSARTAN	Northwind Health Company, LLC	04b3301f-e054-ed5d-e063-6294a90a819c	2026-06-25	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALSARTAN
Valsartan	VALSARTAN	Northwind Health Company, LLC	04b3c573-4ef7-5cf6-e063-6294a90a2c5f	2026-06-25	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALSARTAN
Valsartan	VALSARTAN	Bryant Ranch Prepack	6e9c4c57-e2c9-461b-9c09-669d3ada4c1a	2026-06-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALSARTAN
Valsartan	VALSARTAN	Bryant Ranch Prepack	7cb9f284-8175-4679-b846-145dc604e2c0	2026-06-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALSARTAN
Valsartan	VALSARTAN	Bryant Ranch Prepack	c12db287-786c-47ae-a1f3-df04ddfd2a70	2026-06-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALSARTAN
Valsartan	VALSARTAN	Bryant Ranch Prepack	b3880f58-ce15-4701-84aa-8eb185cf43e2	2026-06-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALSARTAN
Valsartan	VALSARTAN	Bryant Ranch Prepack	7b523502-62b3-425e-960b-f0a58919d3ec	2026-06-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALSARTAN
Valsartan	VALSARTAN	Laurus Labs Limited	6e1f63ad-e554-421b-a699-4e8c9bd4d239	2026-04-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALSARTAN
Valsartan	VALSARTAN	A-S Medication Solutions	0925a24f-6a72-4c77-b4e6-0a8f5b12c8d0	2026-03-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALSARTAN
Valsartan	VALSARTAN	PD-Rx Pharmaceuticals, Inc.	4d6e85d8-7d51-4447-b43d-c2a77f4fe3ae	2026-03-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALSARTAN
Valsartan	VALSARTAN	Camber Pharmaceuticals, Inc.	d6e84105-9394-4ef0-928c-20d07d3fbaa9	2026-02-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALSARTAN

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
47125	SUPPL	2017-02-07
47110	SUPPL	2017-02-06
12951	SUPPL	2015-07-30
25471	SUPPL	2015-07-28
35108	SUPPL	2014-09-26
3034	SUPPL	2014-09-26
25470	SUPPL	2014-03-19
12950	SUPPL	2014-03-19
12949	SUPPL	2014-03-19
3033	SUPPL	2014-03-19
35107	SUPPL	2013-10-31
3032	SUPPL	2013-10-30
23589	ORIG	2011-12-22
41531	ORIG	2010-03-16
41532	SUPPL	2003-08-08
41533	SUPPL	2002-08-14
35106	SUPPL	2002-08-14
3031	SUPPL	2002-08-14