Application 203026

Type: ANDA
Sponsor: APOTEX INC

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
A203026-001	VALSARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; VALSARTAN	12.5MG;80MG	TABLET / ORAL	2013-03-21
A203026-002	VALSARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; VALSARTAN	12.5MG;160MG	TABLET / ORAL	2013-03-21
A203026-003	VALSARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; VALSARTAN	12.5MG;320MG	TABLET / ORAL	2013-03-21
A203026-004	VALSARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; VALSARTAN	25MG;160MG	TABLET / ORAL	2013-03-21
A203026-005	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	A203026-001	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	2013-03-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203026-002	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;160MG	TABLET / ORAL	2013-03-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203026-003	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;320MG	TABLET / ORAL	2013-03-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203026-004	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;160MG	TABLET / ORAL	2013-03-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203026-005	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;320MG	TABLET / ORAL	2013-03-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203026-001	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	2013-03-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203026-002	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;160MG	TABLET / ORAL	2013-03-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203026-003	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;320MG	TABLET / ORAL	2013-03-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203026-004	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;160MG	TABLET / ORAL	2013-03-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203026-005	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;320MG	TABLET / ORAL	2013-03-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203026-001	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	2013-03-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203026-002	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;160MG	TABLET / ORAL	2013-03-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203026-003	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;320MG	TABLET / ORAL	2013-03-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203026-004	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;160MG	TABLET / ORAL	2013-03-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203026-005	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;320MG	TABLET / ORAL	2013-03-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203026-001	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	A203026-002	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	A203026-003	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	A203026-004	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;160MG	TABLET / ORAL	2013-03-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203026-005	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;320MG	TABLET / ORAL	2013-03-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203026-001	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	2013-03-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203026-002	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;160MG	TABLET / ORAL	2013-03-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203026-003	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;320MG	TABLET / ORAL	2013-03-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203026-004	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;160MG	TABLET / ORAL	2013-03-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203026-005	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;320MG	TABLET / ORAL	2013-03-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203026-001	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	A203026-002	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	A203026-003	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	A203026-004	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;160MG	TABLET / ORAL	2013-03-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203026-005	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;320MG	TABLET / ORAL	2013-03-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203026-001	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	A203026-002	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	A203026-003	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	A203026-004	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;160MG	TABLET / ORAL	2013-03-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203026-005	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;320MG	TABLET / ORAL	2013-03-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203026-001	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	A203026-002	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	A203026-003	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	A203026-004	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;160MG	TABLET / ORAL	2013-03-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203026-005	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 1 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	Bryant Ranch Prepack	167f49f0-2d39-49a2-9f9e-1359a7c7ba3d	2026-07-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valsartan and Hydrochlorothiazide
VALSARTAN AND HYDROCHLOROTHIAZIDE	VALSARTAN AND HYDROCHLOROTHIAZIDE	ScieGen Pharmaceuticals, INC.	17362ff8-07bb-42c6-a100-8adb93be0348	2026-07-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: VALSARTAN AND HYDROCHLOROTHIAZIDE
Valsartan and Hydrochlorothiazide	VALSARTAN AND HYDROCHLOROTHIAZIDE	Northwind Health Company, LLC	191d5710-7b8a-0b61-e063-6394a90afd41	2026-06-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valsartan and Hydrochlorothiazide
VALSARTAN AND HYDROCHLOROTHIAZIDE	VALSARTAN AND HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	af46984c-cb58-4886-baa2-0ee075242c27	2026-02-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: VALSARTAN AND HYDROCHLOROTHIAZIDE
Valsartan and Hydrochlorothiazide	VALSARTAN AND HYDROCHLOROTHIAZIDE	AvKARE	05ba1369-6484-75d4-e063-6294a90a63e4	2026-01-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valsartan and Hydrochlorothiazide
Valsartan and Hydrochlorothiazide	VALSARTAN AND HYDROCHLOROTHIAZIDE	A-S Medication Solutions	09c55798-5313-4250-8d8f-9c5644e8c1b0	2026-01-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valsartan and Hydrochlorothiazide
Valsartan and Hydrochlorothiazide	VALSARTAN AND HYDROCHLOROTHIAZIDE	Northwind Health Company, LLC	f2b749a6-17ff-e044-e053-2995a90aea28	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valsartan and Hydrochlorothiazide
Valsartan and Hydrochlorothiazide	VALSARTAN AND HYDROCHLOROTHIAZIDE	Northwind Health Company, LLC	f835fa93-6529-c06d-e053-6394a90ad42a	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valsartan and Hydrochlorothiazide
Valsartan and Hydrochlorothiazide	VALSARTAN AND HYDROCHLOROTHIAZIDE	Northwind Health Company, LLC	db118092-2002-7a55-e053-2a95a90a7b2c	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valsartan and Hydrochlorothiazide
Valsartan and Hydrochlorothiazide	VALSARTAN AND HYDROCHLOROTHIAZIDE	Northwind Health Company, LLC	db4d84ce-cf51-61dc-e053-2a95a90a2cfd	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valsartan and Hydrochlorothiazide
VALSARTAN AND HYDROCHLOROTHIAZIDE	VALSARTAN AND HYDROCHLOROTHIAZIDE	Preferred Pharmaceuticals Inc.	d09747f0-029e-4090-949b-e939948249b5	2025-10-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: VALSARTAN AND HYDROCHLOROTHIAZIDE
VALSARTAN AND HYDROCHLOROTHIAZIDE	VALSARTAN AND HYDROCHLOROTHIAZIDE	Solco Healthcare US, LLC	f8b0a8ab-4549-4553-a127-bf2c0291a4b1	2025-07-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: VALSARTAN AND HYDROCHLOROTHIAZIDE
VALSARTAN AND HYDROCHLOROTHIAZIDE	VALSARTAN AND HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	f1df0d1e-d418-4f6e-a04a-77b5d4000e2b	2025-06-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: VALSARTAN AND HYDROCHLOROTHIAZIDE
VALSARTAN AND HYDROCHLOROTHIAZIDE	VALSARTAN AND HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	d55b2f01-5cd1-40bb-8d36-34b5b9081ddc	2025-05-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: VALSARTAN AND HYDROCHLOROTHIAZIDE
VALSARTAN AND HYDROCHLOROTHIAZIDE	VALSARTAN AND HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	46addda8-f798-4207-b8fb-ea75c5903a36	2025-05-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: VALSARTAN AND HYDROCHLOROTHIAZIDE
VALSARTAN AND HYDROCHLOROTHIAZIDE	VALSARTAN AND HYDROCHLOROTHIAZIDE	A-S Medication Solutions	3f1321b2-cad7-47c7-863f-38aa7a8b3599	2024-11-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: VALSARTAN AND HYDROCHLOROTHIAZIDE
VALSARTAN AND HYDROCHLOROTHIAZIDE	VALSARTAN AND HYDROCHLOROTHIAZIDE	A-S Medication Solutions	93833cf2-631b-4058-809d-16cc11b858c0	2024-11-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: VALSARTAN AND HYDROCHLOROTHIAZIDE
VALSARTAN AND HYDROCHLOROTHIAZIDE	VALSARTAN AND HYDROCHLOROTHIAZIDE	A-S Medication Solutions	b6dc0544-898e-41e3-bd18-5757ede4477d	2024-11-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: VALSARTAN AND HYDROCHLOROTHIAZIDE
Valsartan and Hydrochlorothiazide	VALSARTAN AND HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	d57188d2-c3af-4879-bf17-f37eaf733aca	2024-07-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valsartan and Hydrochlorothiazide
Valsartan and Hydrochlorothiazide	VALSARTAN AND HYDROCHLOROTHIAZIDE	Aurobindo Pharma Limited	c5bc7c55-b50c-4e61-ad1f-5ebb607c262f	2024-06-15	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 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63187-241	valsartan and hydrochlorothiazide	valsartan and hydrochlorothiazide	Proficient Rx LP	ANDA	Current