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 2 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	Alembic Pharmaceuticals Inc.	973973a3-9fec-4afc-910f-187f099dfe2d	2024-06-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valsartan and Hydrochlorothiazide
Valsartan and Hydrochlorothiazide	VALSARTAN AND HYDROCHLOROTHIAZIDE	A-S Medication Solutions	ddc8b9e7-ceb1-4b6c-aa98-1c2cb98b0fc8	2024-02-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valsartan and Hydrochlorothiazide
Valsartan and Hydrochlorothiazide	VALSARTAN AND HYDROCHLOROTHIAZIDE	A-S Medication Solutions	7b3fbdc9-d7e0-498f-a52d-e8a6b34f4a1f	2024-01-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valsartan and Hydrochlorothiazide
Valsartan and Hydrochlorothiazide	VALSARTAN AND HYDROCHLOROTHIAZIDE	Lupin Pharmaceuticals, Inc.	d74a85de-5917-401a-b92d-6a95da5d30a6	2023-11-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valsartan and Hydrochlorothiazide
VALSARTAN AND HYDROCHLOROTHIAZIDE	VALSARTAN AND HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	38d84a2b-3c83-44a0-97d8-3f64d6101732	2023-11-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: VALSARTAN AND HYDROCHLOROTHIAZIDE
Valsartan and Hydrochlorothiazide	VALSARTAN AND HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	497223a9-0d53-4f79-b031-07cc5204d80f	2023-11-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valsartan and Hydrochlorothiazide
VALSARTAN AND HYDROCHLOROTHIAZIDE	VALSARTAN AND HYDROCHLOROTHIAZIDE	A-S Medication Solutions	3131809e-885a-42d3-b6ad-1b208fd3ba56	2023-10-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: VALSARTAN AND HYDROCHLOROTHIAZIDE
Valsartan and Hydrochlorothiazide	VALSARTAN AND HYDROCHLOROTHIAZIDE	A-S Medication Solutions	89ce2fb1-330c-45f9-bd37-b402feea9378	2023-10-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valsartan and Hydrochlorothiazide
Valsartan and Hydrochlorothiazide	VALSARTAN AND HYDROCHLOROTHIAZIDE	A-S Medication Solutions	1b72ecfd-a08d-48c5-a853-d3bc9ff882f1	2023-05-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valsartan and Hydrochlorothiazide
Valsartan and Hydrochlorothiazide	VALSARTAN AND HYDROCHLOROTHIAZIDE	Amneal Pharmaceuticals of New York LLC	d5a1db33-3046-407c-a557-6b41642164a9	2023-05-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valsartan and Hydrochlorothiazide
Valsartan and Hydrochlorothiazide	VALSARTAN AND HYDROCHLOROTHIAZIDE	Mylan Pharmaceuticals Inc.	3ba1f9f9-0037-4522-8605-e27dc8552b5b	2023-04-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valsartan and Hydrochlorothiazide
Valsartan and Hydrochlorothiazide	VALSARTAN AND HYDROCHLOROTHIAZIDE	A-S Medication Solutions	ef100fa1-dd63-4287-8543-480a82ace168	2023-02-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valsartan and Hydrochlorothiazide
Valsartan and Hydrochlorothiazide	VALSARTAN AND HYDROCHLOROTHIAZIDE	A-S Medication Solutions	f1ef2a2c-7b8d-4127-8f47-29e430fba70b	2023-02-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valsartan and Hydrochlorothiazide
Valsartan and Hydrochlorothiazide	VALSARTAN AND HYDROCHLOROTHIAZIDE	Alembic Pharmaceuticals Limited	3b80f726-9e1e-4d44-ad4f-afd10e26292f	2023-01-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valsartan and Hydrochlorothiazide
valsartan and hydrochlorothiazide	VALSARTAN AND HYDROCHLOROTHIAZIDE	Zydus Lifesciences Limited	bd199010-1d85-4011-939c-4704ecfaba1f	2022-11-05		Name fallback brand name: valsartan and hydrochlorothiazide
Valsartan and Hydrochlorothiazide	VALSARTAN AND HYDROCHLOROTHIAZIDE	Macleods Pharmaceuticals Limited	771afba6-8769-4ea8-afec-358dba0aaefe	2022-11-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valsartan and Hydrochlorothiazide
Valsartan and Hydrochlorothiazide	VALSARTAN AND HYDROCHLOROTHIAZIDE	Proficient Rx LP	a9098fc6-3d2a-404f-a4cd-2e181ebbd626	2022-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valsartan and Hydrochlorothiazide
Valsartan and Hydrochlorothiazide	VALSARTAN AND HYDROCHLOROTHIAZIDE	Proficient Rx LP	e0349fe8-90a4-4236-9686-f0c9c00a001c	2022-05-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valsartan and Hydrochlorothiazide
Valsartan and Hydrochlorothiazide	VALSARTAN AND HYDROCHLOROTHIAZIDE	Proficient Rx LP	75b3f944-b4fc-40a5-a4e2-aec2fbab64b8	2021-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valsartan and Hydrochlorothiazide
Valsartan and Hydrochlorothiazide	VALSARTAN AND HYDROCHLOROTHIAZIDE	Proficient Rx LP	a06ee3c1-bd0d-4dda-a453-1655eebffdae	2019-11-01	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