Application 020818

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DIOVAN HCT	HYDROCHLOROTHIAZIDE; VALSARTAN	TABLET;ORAL	12.5MG;80MG	Yes	No
002	DIOVAN HCT	HYDROCHLOROTHIAZIDE; VALSARTAN	TABLET;ORAL	12.5MG;160MG	Yes	No
003	DIOVAN HCT	HYDROCHLOROTHIAZIDE; VALSARTAN	TABLET;ORAL	25MG;160MG	Yes	No
004	DIOVAN HCT	HYDROCHLOROTHIAZIDE; VALSARTAN	TABLET;ORAL	12.5MG;320MG	Yes	No
005	DIOVAN HCT	HYDROCHLOROTHIAZIDE; VALSARTAN	TABLET;ORAL	25MG;320MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020818-001	DIOVAN HCT	HYDROCHLOROTHIAZIDE; VALSARTAN	12.5MG;80MG	TABLET / ORAL	AB	RLD	1998-03-06
N020818-002	DIOVAN HCT	HYDROCHLOROTHIAZIDE; VALSARTAN	12.5MG;160MG	TABLET / ORAL	AB	RLD	1998-03-06
N020818-003	DIOVAN HCT	HYDROCHLOROTHIAZIDE; VALSARTAN	25MG;160MG	TABLET / ORAL	AB	RLD	2002-01-17
N020818-004	DIOVAN HCT	HYDROCHLOROTHIAZIDE; VALSARTAN	12.5MG;320MG	TABLET / ORAL	AB	RLD	2006-04-28
N020818-005	DIOVAN HCT	HYDROCHLOROTHIAZIDE; VALSARTAN	25MG;320MG	TABLET / ORAL	AB	RLD, RS	2006-04-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
N020818-001	AB
N020818-002	AB
N020818-003	AB
N020818-004	AB
N020818-005	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 6 · 205 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
2026-02-19 14:30 UTC	2026-02	N020818-001	DIOVAN HCT	12.5MG;80MG	TABLET / ORAL	AB	RLD	1998-03-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020818-002	DIOVAN HCT	12.5MG;160MG	TABLET / ORAL	AB	RLD	1998-03-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020818-003	DIOVAN HCT	25MG;160MG	TABLET / ORAL	AB	RLD	2002-01-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020818-004	DIOVAN HCT	12.5MG;320MG	TABLET / ORAL	AB	RLD	2006-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020818-005	DIOVAN HCT	25MG;320MG	TABLET / ORAL	AB	RLD, RS	2006-04-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020818-001	DIOVAN HCT	12.5MG;80MG	TABLET / ORAL	AB	RLD	1998-03-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020818-002	DIOVAN HCT	12.5MG;160MG	TABLET / ORAL	AB	RLD	1998-03-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020818-003	DIOVAN HCT	25MG;160MG	TABLET / ORAL	AB	RLD	2002-01-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020818-004	DIOVAN HCT	12.5MG;320MG	TABLET / ORAL	AB	RLD	2006-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020818-005	DIOVAN HCT	25MG;320MG	TABLET / ORAL	AB	RLD, RS	2006-04-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020818-001	DIOVAN HCT	12.5MG;80MG	TABLET / ORAL	AB	RLD	1998-03-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020818-002	DIOVAN HCT	12.5MG;160MG	TABLET / ORAL	AB	RLD	1998-03-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020818-003	DIOVAN HCT	25MG;160MG	TABLET / ORAL	AB	RLD	2002-01-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020818-004	DIOVAN HCT	12.5MG;320MG	TABLET / ORAL	AB	RLD	2006-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020818-005	DIOVAN HCT	25MG;320MG	TABLET / ORAL	AB	RLD, RS	2006-04-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020818-001	DIOVAN HCT	12.5MG;80MG	TABLET / ORAL	AB	RLD	1998-03-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020818-002	DIOVAN HCT	12.5MG;160MG	TABLET / ORAL	AB	RLD	1998-03-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020818-003	DIOVAN HCT	25MG;160MG	TABLET / ORAL	AB	RLD	2002-01-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020818-004	DIOVAN HCT	12.5MG;320MG	TABLET / ORAL	AB	RLD	2006-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020818-005	DIOVAN HCT	25MG;320MG	TABLET / ORAL	AB	RLD, RS	2006-04-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020818-001	DIOVAN HCT	12.5MG;80MG	TABLET / ORAL	AB	RLD	1998-03-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020818-002	DIOVAN HCT	12.5MG;160MG	TABLET / ORAL	AB	RLD	1998-03-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020818-003	DIOVAN HCT	25MG;160MG	TABLET / ORAL	AB	RLD	2002-01-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020818-004	DIOVAN HCT	12.5MG;320MG	TABLET / ORAL	AB	RLD	2006-04-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020818-005	DIOVAN HCT	25MG;320MG	TABLET / ORAL	AB	RLD, RS	2006-04-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020818-001	DIOVAN HCT	12.5MG;80MG	TABLET / ORAL	AB	RLD	1998-03-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020818-002	DIOVAN HCT	12.5MG;160MG	TABLET / ORAL	AB	RLD	1998-03-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020818-003	DIOVAN HCT	25MG;160MG	TABLET / ORAL	AB	RLD	2002-01-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020818-004	DIOVAN HCT	12.5MG;320MG	TABLET / ORAL	AB	RLD	2006-04-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020818-005	DIOVAN HCT	25MG;320MG	TABLET / ORAL	AB	RLD, RS	2006-04-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020818-001	DIOVAN HCT	12.5MG;80MG	TABLET / ORAL	AB	RLD	1998-03-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020818-002	DIOVAN HCT	12.5MG;160MG	TABLET / ORAL	AB	RLD	1998-03-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020818-003	DIOVAN HCT	25MG;160MG	TABLET / ORAL	AB	RLD	2002-01-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020818-004	DIOVAN HCT	12.5MG;320MG	TABLET / ORAL	AB	RLD	2006-04-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020818-005	DIOVAN HCT	25MG;320MG	TABLET / ORAL	AB	RLD, RS	2006-04-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020818-001	DIOVAN HCT	12.5MG;80MG	TABLET / ORAL	AB	RLD	1998-03-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020818-002	DIOVAN HCT	12.5MG;160MG	TABLET / ORAL	AB	RLD	1998-03-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020818-003	DIOVAN HCT	25MG;160MG	TABLET / ORAL	AB	RLD	2002-01-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020818-004	DIOVAN HCT	12.5MG;320MG	TABLET / ORAL	AB	RLD	2006-04-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020818-005	DIOVAN HCT	25MG;320MG	TABLET / ORAL	AB	RLD, RS	2006-04-28	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 205 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	N020818-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020818-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020818-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020818-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020818-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020818-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020818-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020818-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020818-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020818-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020818-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020818-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020818-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020818-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020818-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020818-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020818-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020818-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020818-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020818-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020818-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020818-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020818-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020818-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020818-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020818-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020818-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020818-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020818-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020818-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020818-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020818-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020818-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020818-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020818-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020818-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020818-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020818-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020818-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020818-005	AB	1	`5bbf6a4d5a75…`

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 HCT	VALSARTAN AND HYDROCHLOROTHIAZIDE	Novartis Pharmaceuticals Corporation	d76a0419-05ee-437e-884c-65807aea9569	2026-02-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020818 application number: NDA020818 ndc (product): 0078-0314 ndc (product): 0078-0471 ndc (product): 0078-0315 ndc (product): 0078-0383 ndc (product): 0078-0472

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 61 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0078-0314	Diovan HCT	valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0314	Diovan HCT	valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0314	Diovan HCT	valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0314	Diovan HCT	valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0314	Diovan HCT	valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0314	Diovan HCT	valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0314	Diovan HCT	valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0315	Diovan HCT	valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0315	Diovan HCT	valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0315	Diovan HCT	valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0315	Diovan HCT	valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0315	Diovan HCT	valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0315	Diovan HCT	valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0315	Diovan HCT	valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0383	Diovan HCT	valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0383	Diovan HCT	valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0383	Diovan HCT	valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0383	Diovan HCT	valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0383	Diovan HCT	valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0383	Diovan HCT	valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0383	Diovan HCT	valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0471	Diovan HCT	valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0471	Diovan HCT	valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0471	Diovan HCT	valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0471	Diovan HCT	valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0471	Diovan HCT	valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0471	Diovan HCT	valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0471	Diovan HCT	valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0472	Diovan HCT	valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0472	Diovan HCT	valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0472	Diovan HCT	valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0472	Diovan HCT	valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0472	Diovan HCT	valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0472	Diovan HCT	valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0472	Diovan HCT	valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0781-5948	Valsartan and Hydrochlorothiazide	valsartan and hydrochlorothiazide	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-5949	Valsartan and Hydrochlorothiazide	valsartan and hydrochlorothiazide	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-5950	Valsartan and Hydrochlorothiazide	valsartan and hydrochlorothiazide	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-5951	Valsartan and Hydrochlorothiazide	valsartan and hydrochlorothiazide	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-5952	Valsartan and Hydrochlorothiazide	valsartan and hydrochlorothiazide	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
55289-820	Diovan HCT	valsartan and hydrochlorothiazide	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-820	Diovan HCT	valsartan and hydrochlorothiazide	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-820	Diovan HCT	valsartan and hydrochlorothiazide	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-820	Diovan HCT	valsartan and hydrochlorothiazide	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-820	Diovan HCT	valsartan and hydrochlorothiazide	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-820	Diovan HCT	valsartan and hydrochlorothiazide	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-820	Diovan HCT	valsartan and hydrochlorothiazide	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-838	Diovan HCT	valsartan and hydrochlorothiazide	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-838	Diovan HCT	valsartan and hydrochlorothiazide	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-838	Diovan HCT	valsartan and hydrochlorothiazide	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-838	Diovan HCT	valsartan and hydrochlorothiazide	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-838	Diovan HCT	valsartan and hydrochlorothiazide	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-838	Diovan HCT	valsartan and hydrochlorothiazide	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-838	Diovan HCT	valsartan and hydrochlorothiazide	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-838	Diovan HCT	valsartan and hydrochlorothiazide	PD-Rx Pharmaceuticals, Inc.	NDA	Current
68258-6053	Diovan HCT	valsartan and hydrochlorothiazide	Dispensing Solutions, Inc.	NDA	Current
68258-6056	Diovan HCT	valsartan and hydrochlorothiazide	Dispensing Solutions, Inc.	NDA	Current
68258-6095	Valsartan and Hydrochlorothiazide	valsartan and hydrochlorothiazide	Dispensing Solutions, Inc.	NDA AUTHORIZED GENERIC	Current
68258-6096	Valsartan and Hydrochlorothiazide	valsartan and hydrochlorothiazide	Dispensing Solutions, Inc.	NDA AUTHORIZED GENERIC	Current
68258-6972	Diovan HCT	valsartan and hydrochlorothiazide	Dispensing Solutions, Inc.	NDA	Current
68258-6973	Diovan HCT	valsartan and hydrochlorothiazide	Dispensing Solutions, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
64430	SUPPL	2020-08-27
64383	SUPPL	2020-08-24
59062	SUPPL	2019-06-13
59057	SUPPL	2019-06-13
35409	SUPPL	2015-07-30
35408	SUPPL	2014-09-26
25908	SUPPL	2014-09-26
13479	SUPPL	2014-06-03
3411	SUPPL	2014-06-03
35407	SUPPL	2014-03-19
25907	SUPPL	2014-03-19
13480	SUPPL	2014-03-19
3412	SUPPL	2014-03-19
25906	SUPPL	2012-10-09
35406	SUPPL	2012-10-05
35405	SUPPL	2012-07-30
25905	SUPPL	2012-07-30
25903	SUPPL	2012-02-17
13477	SUPPL	2012-02-17
25904	SUPPL	2012-01-23
13478	SUPPL	2012-01-23
23600	ORIG	2011-12-22
25902	SUPPL	2011-12-14
25900	SUPPL	2011-12-14
35404	SUPPL	2011-12-12
35402	SUPPL	2011-12-12
35403	SUPPL	2011-06-27
25901	SUPPL	2011-06-09
13476	SUPPL	2010-05-03
3410	SUPPL	2010-04-23
25899	SUPPL	2008-08-05
25898	SUPPL	2007-09-11
25897	SUPPL	2006-12-04
13475	SUPPL	2006-11-22
25896	SUPPL	2006-05-02
13474	SUPPL	2006-05-02
35401	SUPPL	2005-07-15
25895	SUPPL	2005-07-15
43564	SUPPL	2005-07-08
25894	SUPPL	2004-06-02
13473	ORIG	2004-06-02
3409	ORIG	2004-06-02
41720	ORIG	2003-08-08
41721	SUPPL	2003-07-08
25893	SUPPL	2002-01-17