Application 091519

Type: ANDA
Sponsor: WATSON LABS TEVA

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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	Approval date
A091519-001	VALSARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; VALSARTAN	12.5MG;80MG	TABLET / ORAL	2013-03-21
A091519-002	VALSARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; VALSARTAN	12.5MG;160MG	TABLET / ORAL	2013-03-21
A091519-003	VALSARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; VALSARTAN	12.5MG;320MG	TABLET / ORAL	2013-03-21
A091519-004	VALSARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; VALSARTAN	25MG;160MG	TABLET / ORAL	2013-03-21
A091519-005	VALSARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; VALSARTAN	25MG;320MG	TABLET / ORAL	2013-03-21

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 · 215 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	A091519-001	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	2013-03-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091519-002	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;160MG	TABLET / ORAL	2013-03-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091519-003	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;320MG	TABLET / ORAL	2013-03-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091519-004	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;160MG	TABLET / ORAL	2013-03-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091519-005	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;320MG	TABLET / ORAL	2013-03-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091519-001	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	2013-03-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091519-002	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;160MG	TABLET / ORAL	2013-03-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091519-003	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;320MG	TABLET / ORAL	2013-03-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091519-004	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;160MG	TABLET / ORAL	2013-03-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091519-005	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;320MG	TABLET / ORAL	2013-03-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091519-001	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	2013-03-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091519-002	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;160MG	TABLET / ORAL	2013-03-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091519-003	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;320MG	TABLET / ORAL	2013-03-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091519-004	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;160MG	TABLET / ORAL	2013-03-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091519-005	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;320MG	TABLET / ORAL	2013-03-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091519-001	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	2013-03-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091519-002	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;160MG	TABLET / ORAL	2013-03-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091519-003	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;320MG	TABLET / ORAL	2013-03-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091519-004	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;160MG	TABLET / ORAL	2013-03-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091519-005	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;320MG	TABLET / ORAL	2013-03-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091519-001	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	2013-03-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091519-002	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;160MG	TABLET / ORAL	2013-03-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091519-003	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;320MG	TABLET / ORAL	2013-03-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091519-004	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;160MG	TABLET / ORAL	2013-03-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091519-005	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;320MG	TABLET / ORAL	2013-03-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091519-001	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	2013-03-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091519-002	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;160MG	TABLET / ORAL	2013-03-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091519-003	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;320MG	TABLET / ORAL	2013-03-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091519-004	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;160MG	TABLET / ORAL	2013-03-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091519-005	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;320MG	TABLET / ORAL	2013-03-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091519-001	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	2013-03-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091519-002	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;160MG	TABLET / ORAL	2013-03-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091519-003	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;320MG	TABLET / ORAL	2013-03-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091519-004	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;160MG	TABLET / ORAL	2013-03-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091519-005	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;320MG	TABLET / ORAL	2013-03-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091519-001	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	2013-03-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091519-002	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;160MG	TABLET / ORAL	2013-03-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091519-003	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;320MG	TABLET / ORAL	2013-03-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091519-004	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;160MG	TABLET / ORAL	2013-03-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091519-005	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;320MG	TABLET / ORAL	2013-03-21	`03ed91905a0d…`

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 3 · 47 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Valsartan and Hydrochlorothiazide	VALSARTAN AND HYDROCHLOROTHIAZIDE	Proficient Rx LP	411caa05-5eff-4285-a940-7f6d2429ba81	2019-11-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valsartan and Hydrochlorothiazide
Valsartan and Hydrochlorothiazide	VALSARTAN AND HYDROCHLOROTHIAZIDE	Proficient Rx LP	e1f94546-c71c-4175-9384-20238181e05f	2019-11-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valsartan and Hydrochlorothiazide
Valsartan and Hydrochlorothiazide	VALSARTAN AND HYDROCHLOROTHIAZIDE	Proficient Rx LP	1f6ab5e0-8320-4489-bed2-8c90c534e5ae	2019-11-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valsartan and Hydrochlorothiazide
Valsartan and Hydrochlorothiazide	VALSARTAN AND HYDROCHLOROTHIAZIDE	Proficient Rx LP	be008c6a-6036-4abf-a3fc-450465c88d55	2019-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valsartan and Hydrochlorothiazide
Valsartan and Hydrochlorothiazide	VALSARTAN AND HYDROCHLOROTHIAZIDE	Proficient Rx LP	ec24af8d-29a3-4217-8f06-ac217ea55b9e	2019-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valsartan and Hydrochlorothiazide
Valsartan and Hydrochlorothiazide	VALSARTAN AND HYDROCHLOROTHIAZIDE	Proficient Rx LP	6c363351-6596-42bf-83c9-041bf231b778	2019-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valsartan and Hydrochlorothiazide
Valsartan and Hydrochlorothiazide	VALSARTAN AND HYDROCHLOROTHIAZIDE	Amneal Pharmaceuticals LLC	c9acbc95-3629-4276-842b-5c074844dba7	2019-02-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valsartan and Hydrochlorothiazide

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 · 23 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0591-2315	Valsartan and Hydrochlorothiazide	Valsartan and Hydrochlorothiazide	Actavis Pharma, Inc.	ANDA	Current
0591-2316	Valsartan and Hydrochlorothiazide	Valsartan and Hydrochlorothiazide	Actavis Pharma, Inc.	ANDA	Current
0591-2317	Valsartan and Hydrochlorothiazide	Valsartan and Hydrochlorothiazide	Actavis Pharma, Inc.	ANDA	Current
0591-2318	Valsartan and Hydrochlorothiazide	Valsartan and Hydrochlorothiazide	Actavis Pharma, Inc.	ANDA	Current
0591-2319	Valsartan and Hydrochlorothiazide	Valsartan and Hydrochlorothiazide	Actavis Pharma, Inc.	ANDA	Current
42291-884	Valsartan and hydrochlorothiazide	Valsartan and hydrochlorothiazide	AvKARE, Inc.	ANDA	Current
42291-884	Valsartan and hydrochlorothiazide	Valsartan and hydrochlorothiazide	AvKARE, Inc.	ANDA	Current
42291-885	Valsartan and hydrochlorothiazide	Valsartan and hydrochlorothiazide	AvKARE, Inc.	ANDA	Current
42291-886	Valsartan and hydrochlorothiazide	Valsartan and hydrochlorothiazide	AvKARE, Inc.	ANDA	Current
42291-886	Valsartan and hydrochlorothiazide	Valsartan and hydrochlorothiazide	AvKARE, Inc.	ANDA	Current
42291-887	Valsartan and hydrochlorothiazide	Valsartan and hydrochlorothiazide	AvKARE, Inc.	ANDA	Current
42291-887	Valsartan and hydrochlorothiazide	Valsartan and hydrochlorothiazide	AvKARE, Inc.	ANDA	Current
42291-888	Valsartan and hydrochlorothiazide	Valsartan and hydrochlorothiazide	AvKARE, Inc.	ANDA	Current
42291-888	Valsartan and hydrochlorothiazide	Valsartan and hydrochlorothiazide	AvKARE, Inc.	ANDA	Current
50090-2640	Valsartan and Hydrochlorothiazide	Valsartan and Hydrochlorothiazide	A-S Medication Solutions	ANDA	Current
51655-950	Valsartan HCTZ	Valsartan HCTZ	Northwind Pharmaceuticals	ANDA	Current
61919-634	VALSARTAN AND HYDROCHLOROTHIAZIDE	VALSARTAN AND HYDROCHLOROTHIAZIDE	DirectRX	ANDA	Current
63187-428	Valsartan and hydrochlorothiazide	Valsartan and hydrochlorothiazide	Proficient Rx LP	ANDA	Current
63187-428	Valsartan and hydrochlorothiazide	Valsartan and hydrochlorothiazide	Proficient Rx LP	ANDA	Current
68071-2119	Valsartan and hydrochlorothiazide	Valsartan and hydrochlorothiazide	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-4311	Valsartan and Hydrochlorothiazide	Valsartan and Hydrochlorothiazide	NuCare Pharmaceuticals,Inc.	ANDA	Current
71205-004	Valsartan and Hydrochlorothiazide	Valsartan and Hydrochlorothiazide	Proficient Rx LP	ANDA	Current
71205-004	Valsartan and Hydrochlorothiazide	Valsartan and Hydrochlorothiazide	Proficient Rx LP	ANDA	Current