Application 203000

Type: ANDA
Sponsor: ZYDUS PHARMS

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 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	Approval date
A203000-001	VALSARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; VALSARTAN	12.5MG;80MG	TABLET / ORAL	2019-03-15
A203000-002	VALSARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; VALSARTAN	12.5MG;160MG	TABLET / ORAL	2019-03-15
A203000-003	VALSARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; VALSARTAN	12.5MG;320MG	TABLET / ORAL	2019-03-15
A203000-004	VALSARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; VALSARTAN	25MG;160MG	TABLET / ORAL	2019-03-15
A203000-005	VALSARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; VALSARTAN	25MG;320MG	TABLET / ORAL	2019-03-15

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203000-001	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	2019-03-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203000-002	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;160MG	TABLET / ORAL	2019-03-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203000-003	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;320MG	TABLET / ORAL	2019-03-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203000-004	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;160MG	TABLET / ORAL	2019-03-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203000-005	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;320MG	TABLET / ORAL	2019-03-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203000-001	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	2019-03-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203000-002	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;160MG	TABLET / ORAL	2019-03-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203000-003	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;320MG	TABLET / ORAL	2019-03-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203000-004	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;160MG	TABLET / ORAL	2019-03-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203000-005	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;320MG	TABLET / ORAL	2019-03-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203000-001	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	2019-03-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203000-002	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;160MG	TABLET / ORAL	2019-03-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203000-003	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;320MG	TABLET / ORAL	2019-03-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203000-004	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;160MG	TABLET / ORAL	2019-03-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203000-005	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;320MG	TABLET / ORAL	2019-03-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203000-001	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	2019-03-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203000-002	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;160MG	TABLET / ORAL	2019-03-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203000-003	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;320MG	TABLET / ORAL	2019-03-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203000-004	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;160MG	TABLET / ORAL	2019-03-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203000-005	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;320MG	TABLET / ORAL	2019-03-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203000-001	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	2019-03-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203000-002	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;160MG	TABLET / ORAL	2019-03-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203000-003	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;320MG	TABLET / ORAL	2019-03-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203000-004	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;160MG	TABLET / ORAL	2019-03-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203000-005	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;320MG	TABLET / ORAL	2019-03-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203000-001	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	2019-03-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203000-002	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;160MG	TABLET / ORAL	2019-03-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203000-003	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;320MG	TABLET / ORAL	2019-03-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203000-004	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;160MG	TABLET / ORAL	2019-03-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203000-005	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;320MG	TABLET / ORAL	2019-03-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203000-001	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	2019-03-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203000-002	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;160MG	TABLET / ORAL	2019-03-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203000-003	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;320MG	TABLET / ORAL	2019-03-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203000-004	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;160MG	TABLET / ORAL	2019-03-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203000-005	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;320MG	TABLET / ORAL	2019-03-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203000-001	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	2019-03-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203000-002	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;160MG	TABLET / ORAL	2019-03-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203000-003	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;320MG	TABLET / ORAL	2019-03-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203000-004	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;160MG	TABLET / ORAL	2019-03-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203000-005	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;320MG	TABLET / ORAL	2019-03-15	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-07-19 19:46 UTC	2019-07	A203000-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A203000-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A203000-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A203000-004	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A203000-005	AB	1	`ea99ee380514…`

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
valsartan and hydrochlorothiazide	VALSARTAN AND HYDROCHLOROTHIAZIDE	Zydus Lifesciences Limited	bd199010-1d85-4011-939c-4704ecfaba1f	2022-11-05		Exact identifier application applno (ANDA): 203000 application number: ANDA203000 ndc (product): 70771-1485 ndc (product): 70771-1487 ndc (product): 70771-1489 ndc (product): 70771-1488 ndc (product): 70771-1486

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 25 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68382-279	valsartan and hydrochlorothiazide	valsartan and hydrochlorothiazide	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-279	valsartan and hydrochlorothiazide	valsartan and hydrochlorothiazide	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-280	valsartan and hydrochlorothiazide	valsartan and hydrochlorothiazide	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-280	valsartan and hydrochlorothiazide	valsartan and hydrochlorothiazide	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-281	valsartan and hydrochlorothiazide	valsartan and hydrochlorothiazide	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-281	valsartan and hydrochlorothiazide	valsartan and hydrochlorothiazide	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-282	valsartan and hydrochlorothiazide	valsartan and hydrochlorothiazide	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-282	valsartan and hydrochlorothiazide	valsartan and hydrochlorothiazide	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-283	valsartan and hydrochlorothiazide	valsartan and hydrochlorothiazide	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-283	valsartan and hydrochlorothiazide	valsartan and hydrochlorothiazide	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70771-1485	valsartan and hydrochlorothiazide	valsartan and hydrochlorothiazide	Cadila Healthcare Limited	ANDA	Current
70771-1485	valsartan and hydrochlorothiazide	valsartan and hydrochlorothiazide	Cadila Healthcare Limited	ANDA	Current
70771-1485	valsartan and hydrochlorothiazide	valsartan and hydrochlorothiazide	Zydus Lifesciences Limited	ANDA	Current
70771-1486	valsartan and hydrochlorothiazide	valsartan and hydrochlorothiazide	Cadila Healthcare Limited	ANDA	Current
70771-1486	valsartan and hydrochlorothiazide	valsartan and hydrochlorothiazide	Cadila Healthcare Limited	ANDA	Current
70771-1486	valsartan and hydrochlorothiazide	valsartan and hydrochlorothiazide	Zydus Lifesciences Limited	ANDA	Current
70771-1487	valsartan and hydrochlorothiazide	valsartan and hydrochlorothiazide	Cadila Healthcare Limited	ANDA	Current
70771-1487	valsartan and hydrochlorothiazide	valsartan and hydrochlorothiazide	Cadila Healthcare Limited	ANDA	Current
70771-1487	valsartan and hydrochlorothiazide	valsartan and hydrochlorothiazide	Zydus Lifesciences Limited	ANDA	Current
70771-1488	valsartan and hydrochlorothiazide	valsartan and hydrochlorothiazide	Cadila Healthcare Limited	ANDA	Current
70771-1488	valsartan and hydrochlorothiazide	valsartan and hydrochlorothiazide	Cadila Healthcare Limited	ANDA	Current
70771-1488	valsartan and hydrochlorothiazide	valsartan and hydrochlorothiazide	Zydus Lifesciences Limited	ANDA	Current
70771-1489	valsartan and hydrochlorothiazide	valsartan and hydrochlorothiazide	Cadila Healthcare Limited	ANDA	Current
70771-1489	valsartan and hydrochlorothiazide	valsartan and hydrochlorothiazide	Cadila Healthcare Limited	ANDA	Current
70771-1489	valsartan and hydrochlorothiazide	valsartan and hydrochlorothiazide	Zydus Lifesciences Limited	ANDA	Current