Application 021283

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DIOVAN	VALSARTAN	TABLET;ORAL	80MG	Yes	No
002	DIOVAN	VALSARTAN	TABLET;ORAL	160MG	Yes	No
003	DIOVAN	VALSARTAN	TABLET;ORAL	320MG	Yes	Yes
004	DIOVAN	VALSARTAN	TABLET;ORAL	40MG	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021283-001	DIOVAN	VALSARTAN	80MG	TABLET / ORAL	AB	RLD	2001-07-18
N021283-002	DIOVAN	VALSARTAN	160MG	TABLET / ORAL	AB	RLD	2001-07-18
N021283-003	DIOVAN	VALSARTAN	320MG	TABLET / ORAL	AB	RLD, RS	2001-07-18
N021283-004	DIOVAN	VALSARTAN	40MG	TABLET / ORAL	AB	RLD	2002-08-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
N021283-001	AB
N021283-002	AB
N021283-003	AB
N021283-004	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 1 of 5 · 168 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
2026-08-18 06:07:40	2026-07	N021283-001	DIOVAN	80MG	TABLET / ORAL	AB	RLD	2001-07-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021283-002	DIOVAN	160MG	TABLET / ORAL	AB	RLD	2001-07-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021283-003	DIOVAN	320MG	TABLET / ORAL	AB	RLD, RS	2001-07-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021283-004	DIOVAN	40MG	TABLET / ORAL	AB	RLD	2002-08-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021283-001	DIOVAN	80MG	TABLET / ORAL	AB	RLD	2001-07-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021283-002	DIOVAN	160MG	TABLET / ORAL	AB	RLD	2001-07-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021283-003	DIOVAN	320MG	TABLET / ORAL	AB	RLD, RS	2001-07-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021283-004	DIOVAN	40MG	TABLET / ORAL	AB	RLD	2002-08-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021283-001	DIOVAN	80MG	TABLET / ORAL	AB	RLD	2001-07-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021283-002	DIOVAN	160MG	TABLET / ORAL	AB	RLD	2001-07-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021283-003	DIOVAN	320MG	TABLET / ORAL	AB	RLD, RS	2001-07-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021283-004	DIOVAN	40MG	TABLET / ORAL	AB	RLD	2002-08-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021283-001	DIOVAN	80MG	TABLET / ORAL	AB	RLD	2001-07-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021283-002	DIOVAN	160MG	TABLET / ORAL	AB	RLD	2001-07-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021283-003	DIOVAN	320MG	TABLET / ORAL	AB	RLD, RS	2001-07-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021283-004	DIOVAN	40MG	TABLET / ORAL	AB	RLD	2002-08-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021283-001	DIOVAN	80MG	TABLET / ORAL	AB	RLD	2001-07-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021283-002	DIOVAN	160MG	TABLET / ORAL	AB	RLD	2001-07-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021283-003	DIOVAN	320MG	TABLET / ORAL	AB	RLD, RS	2001-07-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021283-004	DIOVAN	40MG	TABLET / ORAL	AB	RLD	2002-08-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021283-001	DIOVAN	80MG	TABLET / ORAL	AB	RLD	2001-07-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021283-002	DIOVAN	160MG	TABLET / ORAL	AB	RLD	2001-07-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021283-003	DIOVAN	320MG	TABLET / ORAL	AB	RLD, RS	2001-07-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021283-004	DIOVAN	40MG	TABLET / ORAL	AB	RLD	2002-08-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021283-001	DIOVAN	80MG	TABLET / ORAL	AB	RLD	2001-07-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021283-002	DIOVAN	160MG	TABLET / ORAL	AB	RLD	2001-07-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021283-003	DIOVAN	320MG	TABLET / ORAL	AB	RLD, RS	2001-07-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021283-004	DIOVAN	40MG	TABLET / ORAL	AB	RLD	2002-08-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021283-001	DIOVAN	80MG	TABLET / ORAL	AB	RLD	2001-07-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021283-002	DIOVAN	160MG	TABLET / ORAL	AB	RLD	2001-07-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021283-003	DIOVAN	320MG	TABLET / ORAL	AB	RLD, RS	2001-07-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021283-004	DIOVAN	40MG	TABLET / ORAL	AB	RLD	2002-08-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021283-001	DIOVAN	80MG	TABLET / ORAL	AB	RLD	2001-07-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021283-002	DIOVAN	160MG	TABLET / ORAL	AB	RLD	2001-07-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021283-003	DIOVAN	320MG	TABLET / ORAL	AB	RLD, RS	2001-07-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021283-004	DIOVAN	40MG	TABLET / ORAL	AB	RLD	2002-08-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021283-001	DIOVAN	80MG	TABLET / ORAL	AB	RLD	2001-07-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021283-002	DIOVAN	160MG	TABLET / ORAL	AB	RLD	2001-07-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021283-003	DIOVAN	320MG	TABLET / ORAL	AB	RLD, RS	2001-07-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021283-004	DIOVAN	40MG	TABLET / ORAL	AB	RLD	2002-08-14	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N021283-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021283-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021283-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021283-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021283-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021283-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021283-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021283-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021283-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021283-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021283-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021283-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021283-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021283-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021283-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021283-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021283-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021283-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021283-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021283-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021283-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021283-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021283-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021283-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021283-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021283-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021283-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021283-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021283-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021283-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021283-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021283-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021283-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021283-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021283-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021283-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021283-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021283-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021283-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021283-004	AB	1	`d8e5a09893c0…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 81 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021283-001	NPP	2024-04-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021283-002	NPP	2024-04-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021283-004	NPP	2024-04-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021283-001	NPP	2024-04-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021283-002	NPP	2024-04-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021283-004	NPP	2024-04-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021283-001	NPP	2024-04-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021283-002	NPP	2024-04-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021283-004	NPP	2024-04-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021283-001	NPP	2024-04-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021283-002	NPP	2024-04-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021283-004	NPP	2024-04-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021283-001	NPP	2024-04-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021283-002	NPP	2024-04-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021283-004	NPP	2024-04-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021283-001	NPP	2024-04-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021283-002	NPP	2024-04-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021283-004	NPP	2024-04-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021283-001	NPP	2024-04-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021283-002	NPP	2024-04-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021283-004	NPP	2024-04-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021283-001	NPP	2024-04-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021283-002	NPP	2024-04-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021283-004	NPP	2024-04-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021283-001	NPP	2024-04-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021283-002	NPP	2024-04-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021283-004	NPP	2024-04-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021283-001	NPP	2024-04-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021283-002	NPP	2024-04-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021283-004	NPP	2024-04-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021283-001	NPP	2024-04-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021283-002	NPP	2024-04-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021283-004	NPP	2024-04-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021283-001	NPP	2024-04-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021283-002	NPP	2024-04-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021283-004	NPP	2024-04-19	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N021283-001	NPP	2024-04-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021283-002	NPP	2024-04-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021283-004	NPP	2024-04-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021283-001	NPP	2024-04-19	`782e0a99824c…`

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
Diovan	VALSARTAN	Novartis Pharmaceuticals Corporation	5ddba454-f3e6-43c2-a7a6-58365d297213	2026-08-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021283 application number: NDA021283 ndc (product): 0078-0358 ndc (product): 0078-0359 ndc (product): 0078-0423 ndc (product): 0078-0360

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 63 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0078-0358	Diovan	valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0358	Diovan	valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0358	Diovan	valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0358	Diovan	valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0358	Diovan	valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0358	Diovan	valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0358	Diovan	valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0359	Diovan	valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0359	Diovan	valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0359	Diovan	valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0359	Diovan	valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0359	Diovan	valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0359	Diovan	valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0359	Diovan	valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0360	Diovan	valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0360	Diovan	valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0360	Diovan	valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0360	Diovan	valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0360	Diovan	valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0360	Diovan	valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0360	Diovan	valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0423	Diovan	valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0423	Diovan	valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0423	Diovan	valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0423	Diovan	valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0423	Diovan	valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0423	Diovan	valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0423	Diovan	valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0781-5607	Valsartan	valsartan	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-5608	Valsartan	valsartan	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-5618	Valsartan	valsartan	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-5619	Valsartan	valsartan	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
21695-917	Diovan	valsartan	Rebel Distributors Corp	NDA	Current
21695-918	Diovan	valsartan	Rebel Distributors Corp	NDA	Current
21695-919	Diovan	valsartan	Rebel Distributors Corp	NDA	Current
43353-059	Valsartan	valsartan	Aphena Pharma Solutions - Tennessee, LLC	NDA AUTHORIZED GENERIC	Current
43353-066	Valsartan	valsartan	Aphena Pharma Solutions - Tennessee, LLC	NDA AUTHORIZED GENERIC	Current
43353-067	Valsartan	valsartan	Aphena Pharma Solutions - Tennessee, LLC	NDA AUTHORIZED GENERIC	Current
55289-817	Diovan	valsartan	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-817	Diovan	valsartan	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-817	Diovan	valsartan	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-817	Diovan	valsartan	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-817	Diovan	valsartan	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-817	Diovan	valsartan	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-825	Diovan	valsartan	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-825	Diovan	valsartan	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-825	Diovan	valsartan	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-825	Diovan	valsartan	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-825	Diovan	valsartan	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-825	Diovan	valsartan	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-825	Diovan	valsartan	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-876	Diovan	valsartan	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-876	Diovan	valsartan	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-876	Diovan	valsartan	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-876	Diovan	valsartan	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-876	Diovan	valsartan	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-876	Diovan	valsartan	PD-Rx Pharmaceuticals, Inc.	NDA	Current
63629-6922	Valsartan	valsartan	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
63629-6922	Valsartan	valsartan	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
67544-403	Diovan	valsartan	Aphena Pharma Solutions - Tennessee, LLC	NDA	Current
67544-404	Diovan	valsartan	Aphena Pharma Solutions - Tennessee, LLC	NDA	Current
68151-4349	Diovan	valsartan	Carilion Materials Management	NDA	Current
68151-5044	Diovan	valsartan	Carilion Materials Management	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85886	SUPPL	2026-05-12
85881	SUPPL	2026-05-12
68560	SUPPL	2021-09-08
68554	SUPPL	2021-09-08
67132	SUPPL	2021-04-22
67124	SUPPL	2021-04-20
59061	SUPPL	2019-06-13
59058	SUPPL	2019-06-13
47126	SUPPL	2017-02-07
47106	SUPPL	2017-02-06
14870	SUPPL	2015-07-30
4898	SUPPL	2015-07-28
4897	SUPPL	2014-10-01
36571	SUPPL	2014-09-30
27365	SUPPL	2014-03-19
14869	SUPPL	2014-03-19
14868	SUPPL	2014-03-19
4896	SUPPL	2014-03-19
4895	SUPPL	2012-10-09
36570	SUPPL	2012-10-05
27364	SUPPL	2012-07-30
14867	SUPPL	2012-07-30
36568	SUPPL	2012-03-06
42079	SUPPL	2012-03-02
42078	SUPPL	2012-03-02
4894	SUPPL	2012-02-29
36569	SUPPL	2012-01-23
27363	SUPPL	2012-01-23
44113	ORIG	2011-12-22
4893	SUPPL	2011-12-14
14866	SUPPL	2011-12-12
36567	SUPPL	2011-06-07
27362	SUPPL	2011-06-07
36566	SUPPL	2009-06-22
4892	SUPPL	2009-06-17
4891	SUPPL	2008-01-09
36565	SUPPL	2007-12-03
4890	SUPPL	2007-08-22
21573	ORIG	2007-06-22
42077	SUPPL	2007-03-31
27361	SUPPL	2006-12-04
14865	SUPPL	2006-12-04
42076	SUPPL	2006-06-06
36563	SUPPL	2006-06-06
27360	SUPPL	2005-08-08
14864	SUPPL	2005-08-08
4889	SUPPL	2004-12-06
36564	SUPPL	2004-12-03
14862	ORIG	2003-05-05
42075	SUPPL	2002-08-14
36562	SUPPL	2002-08-14
4888	SUPPL	2002-08-14
27359	SUPPL	2002-04-05
21574	SUPPL	2002-04-05
14863	SUPPL	2002-04-05
53436	ORIG	1900-01-01
53435	ORIG	1900-01-01
53434	ORIG	1900-01-01