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 43.

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 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N020665-001	DIOVAN	80MG	CAPSULE / ORAL	1996-12-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020665-002	DIOVAN	160MG	CAPSULE / ORAL	1996-12-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020665-001	DIOVAN	80MG	CAPSULE / ORAL	1996-12-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020665-002	DIOVAN	160MG	CAPSULE / ORAL	1996-12-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020665-001	DIOVAN	80MG	CAPSULE / ORAL	1996-12-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020665-002	DIOVAN	160MG	CAPSULE / ORAL	1996-12-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020665-001	DIOVAN	80MG	CAPSULE / ORAL	1996-12-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020665-002	DIOVAN	160MG	CAPSULE / ORAL	1996-12-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020665-001	DIOVAN	80MG	CAPSULE / ORAL	1996-12-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020665-002	DIOVAN	160MG	CAPSULE / ORAL	1996-12-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020665-001	DIOVAN	80MG	CAPSULE / ORAL	1996-12-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020665-002	DIOVAN	160MG	CAPSULE / ORAL	1996-12-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020665-001	DIOVAN	80MG	CAPSULE / ORAL	1996-12-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020665-002	DIOVAN	160MG	CAPSULE / ORAL	1996-12-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020665-001	DIOVAN	80MG	CAPSULE / ORAL	1996-12-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020665-002	DIOVAN	160MG	CAPSULE / ORAL	1996-12-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020665-001	DIOVAN	80MG	CAPSULE / ORAL	1996-12-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020665-002	DIOVAN	160MG	CAPSULE / ORAL	1996-12-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020665-001	DIOVAN	80MG	CAPSULE / ORAL	1996-12-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020665-002	DIOVAN	160MG	CAPSULE / ORAL	1996-12-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020665-001	DIOVAN	80MG	CAPSULE / ORAL	1996-12-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020665-002	DIOVAN	160MG	CAPSULE / ORAL	1996-12-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020665-001	DIOVAN	80MG	CAPSULE / ORAL	1996-12-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020665-002	DIOVAN	160MG	CAPSULE / ORAL	1996-12-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020665-001	DIOVAN	80MG	CAPSULE / ORAL	1996-12-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020665-002	DIOVAN	160MG	CAPSULE / ORAL	1996-12-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020665-001	DIOVAN	80MG	CAPSULE / ORAL	1996-12-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020665-002	DIOVAN	160MG	CAPSULE / ORAL	1996-12-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020665-001	DIOVAN	80MG	CAPSULE / ORAL	1996-12-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020665-002	DIOVAN	160MG	CAPSULE / ORAL	1996-12-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020665-001	DIOVAN	80MG	CAPSULE / ORAL	1996-12-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020665-002	DIOVAN	160MG	CAPSULE / ORAL	1996-12-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020665-001	DIOVAN	80MG	CAPSULE / ORAL	1996-12-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020665-002	DIOVAN	160MG	CAPSULE / ORAL	1996-12-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020665-001	DIOVAN	80MG	CAPSULE / ORAL	1996-12-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020665-002	DIOVAN	160MG	CAPSULE / ORAL	1996-12-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020665-001	DIOVAN	80MG	CAPSULE / ORAL	1996-12-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020665-002	DIOVAN	160MG	CAPSULE / ORAL	1996-12-23	`4b0b4de00fa7…`
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…`

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 3 of 4 · 62 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Valsartan	VALSARTAN	Zydus Lifesciences Limited	1b60c816-7399-42c3-8b74-4dc9d82873ec	2024-07-23		Name fallback generic name: VALSARTAN
Valsartan	VALSARTAN	Aurobindo Pharma Limited	a81a72dd-e828-4208-af9b-bb9ac4938537	2024-05-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALSARTAN
Valsartan	VALSARTAN	Lupin Pharmaceuticals, Inc.	9eb9d98e-7057-4ca0-91ab-2030bc0120a6	2024-03-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALSARTAN
Valsartan	VALSARTAN	Bryant Ranch Prepack	d9a16816-d4de-401a-8413-7233f4e541f8	2024-01-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALSARTAN
Valsartan	VALSARTAN	Amneal Pharmaceuticals of New York LLC	f13587f8-76cb-49ad-9291-5907249d6b8e	2023-12-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALSARTAN
Valsartan	VALSARTAN	Bryant Ranch Prepack	e8fcd4c2-8baa-452a-b723-5cb3d8d203a9	2023-12-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALSARTAN
Valsartan	VALSARTAN	Bryant Ranch Prepack	4e160647-a08e-40e8-b566-3e97a09c616a	2023-11-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALSARTAN
Valsartan	VALSARTAN	A-S Medication Solutions	688b5c82-2eba-445c-869e-60609f5db86a	2023-10-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALSARTAN
Valsartan	VALSARTAN	Bryant Ranch Prepack	bcbd44f6-d49a-4a59-bba5-70fb843d1f59	2023-09-25	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALSARTAN
Valsartan	VALSARTAN	ANI Pharmaceuticals, Inc.	959b6790-feb7-45a9-9ea4-0ee1a7fce048	2023-09-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALSARTAN
Valsartan	VALSARTAN	Amneal Pharmaceuticals LLC	f4a5df78-157b-4996-845c-235234250f11	2023-08-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALSARTAN
Valsartan	VALSARTAN	SQUARE PHARMACEUTICALS LIMITED	5ee97546-2a7c-40fa-9e05-b7993a72dfbf	2023-07-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALSARTAN
valsartan	VALSARTAN	A-S Medication Solutions	80987771-ccb4-4a9f-a395-0af4c2621e0a	2023-02-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALSARTAN
valsartan	VALSARTAN	A-S Medication Solutions	e352db8b-0485-492a-8734-0a415566d764	2023-02-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALSARTAN
valsartan	VALSARTAN	A-S Medication Solutions	9f5a400f-9cfc-4d25-a677-73cbb14375e2	2023-02-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALSARTAN
Valsartan	VALSARTAN	A-S Medication Solutions	506ab3dd-c5eb-4755-ad10-bc116f4443c7	2023-01-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALSARTAN
Valsartan	VALSARTAN	Alembic Pharmaceuticals Limited	6e2cd953-88bf-4094-8ba8-2c9ba020f4d7	2023-01-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALSARTAN
Valsartan	VALSARTAN	Proficient Rx LP	fadb25bb-acd9-4aaf-971c-82259b739e5b	2022-11-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALSARTAN
Valsartan	VALSARTAN	Lifsa Drugs LLC	130e1659-9c2d-49ca-9db8-d28aa23fd133	2022-04-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALSARTAN
Valsartan	VALSARTAN	Unichem Pharmaceuticals (USA), Inc.	93b82a9f-dc0a-4f7d-b0d4-4adf0d917b7e	2021-09-09	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