Application 218169

Type: ANDA
Sponsor: RENATA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VALSARTAN	VALSARTAN	TABLET;ORAL	40MG	No	No
002	VALSARTAN	VALSARTAN	TABLET;ORAL	80MG	No	No
003	VALSARTAN	VALSARTAN	TABLET;ORAL	160MG	No	No
004	VALSARTAN	VALSARTAN	TABLET;ORAL	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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A218169-001	VALSARTAN	VALSARTAN	40MG	TABLET / ORAL	2024-08-05
A218169-002	VALSARTAN	VALSARTAN	80MG	TABLET / ORAL	2024-08-05
A218169-003	VALSARTAN	VALSARTAN	160MG	TABLET / ORAL	2024-08-05
A218169-004	VALSARTAN	VALSARTAN	320MG	TABLET / ORAL	2024-08-05

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 2 · 48 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A218169-001	VALSARTAN	40MG	TABLET / ORAL		2024-08-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218169-002	VALSARTAN	80MG	TABLET / ORAL		2024-08-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218169-003	VALSARTAN	160MG	TABLET / ORAL		2024-08-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218169-004	VALSARTAN	320MG	TABLET / ORAL		2024-08-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218169-001	VALSARTAN	40MG	TABLET / ORAL		2024-08-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218169-002	VALSARTAN	80MG	TABLET / ORAL		2024-08-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218169-003	VALSARTAN	160MG	TABLET / ORAL		2024-08-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218169-004	VALSARTAN	320MG	TABLET / ORAL		2024-08-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218169-001	VALSARTAN	40MG	TABLET / ORAL		2024-08-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218169-002	VALSARTAN	80MG	TABLET / ORAL		2024-08-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218169-003	VALSARTAN	160MG	TABLET / ORAL		2024-08-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218169-004	VALSARTAN	320MG	TABLET / ORAL		2024-08-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218169-001	VALSARTAN	40MG	TABLET / ORAL		2024-08-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218169-002	VALSARTAN	80MG	TABLET / ORAL		2024-08-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218169-003	VALSARTAN	160MG	TABLET / ORAL		2024-08-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218169-004	VALSARTAN	320MG	TABLET / ORAL		2024-08-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218169-001	VALSARTAN	40MG	TABLET / ORAL	AB	2024-08-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218169-002	VALSARTAN	80MG	TABLET / ORAL	AB	2024-08-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218169-003	VALSARTAN	160MG	TABLET / ORAL	AB	2024-08-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218169-004	VALSARTAN	320MG	TABLET / ORAL	AB	2024-08-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218169-001	VALSARTAN	40MG	TABLET / ORAL	AB	2024-08-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218169-002	VALSARTAN	80MG	TABLET / ORAL	AB	2024-08-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218169-003	VALSARTAN	160MG	TABLET / ORAL	AB	2024-08-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218169-004	VALSARTAN	320MG	TABLET / ORAL	AB	2024-08-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218169-001	VALSARTAN	40MG	TABLET / ORAL	AB	2024-08-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218169-002	VALSARTAN	80MG	TABLET / ORAL	AB	2024-08-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218169-003	VALSARTAN	160MG	TABLET / ORAL	AB	2024-08-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218169-004	VALSARTAN	320MG	TABLET / ORAL	AB	2024-08-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A218169-001	VALSARTAN	40MG	TABLET / ORAL	AB	2024-08-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A218169-002	VALSARTAN	80MG	TABLET / ORAL	AB	2024-08-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A218169-003	VALSARTAN	160MG	TABLET / ORAL	AB	2024-08-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A218169-004	VALSARTAN	320MG	TABLET / ORAL	AB	2024-08-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218169-001	VALSARTAN	40MG	TABLET / ORAL	AB	2024-08-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218169-002	VALSARTAN	80MG	TABLET / ORAL	AB	2024-08-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218169-003	VALSARTAN	160MG	TABLET / ORAL	AB	2024-08-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218169-004	VALSARTAN	320MG	TABLET / ORAL	AB	2024-08-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A218169-001	VALSARTAN	40MG	TABLET / ORAL	AB	2024-08-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A218169-002	VALSARTAN	80MG	TABLET / ORAL	AB	2024-08-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A218169-003	VALSARTAN	160MG	TABLET / ORAL	AB	2024-08-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A218169-004	VALSARTAN	320MG	TABLET / ORAL	AB	2024-08-05	`d06236e962d9…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218169-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218169-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218169-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218169-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218169-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218169-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218169-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218169-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218169-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218169-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218169-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218169-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A218169-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A218169-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A218169-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A218169-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218169-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218169-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218169-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218169-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A218169-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A218169-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A218169-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A218169-004	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A218169-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A218169-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A218169-003	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A218169-004	AB	1	`79d66fd596c7…`

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 · 60 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Valsartan	VALSARTAN	ScieGen Pharmaceuticals, INC.	1a8af3d9-4053-4233-82a7-e8c7bc9e302f	2026-07-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valsartan generic name: VALSARTAN
Valsartan	VALSARTAN	A-S Medication Solutions	bb3c66a7-d397-4df5-822f-4a1f797f54fc	2026-07-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valsartan generic name: VALSARTAN
Valsartan	VALSARTAN	Northwind Health Company, LLC	04b3301f-e054-ed5d-e063-6294a90a819c	2026-06-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valsartan generic name: VALSARTAN
Valsartan	VALSARTAN	Northwind Health Company, LLC	04b3c573-4ef7-5cf6-e063-6294a90a2c5f	2026-06-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valsartan generic name: VALSARTAN
Valsartan	VALSARTAN	Bryant Ranch Prepack	6e9c4c57-e2c9-461b-9c09-669d3ada4c1a	2026-06-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valsartan generic name: VALSARTAN
Valsartan	VALSARTAN	Bryant Ranch Prepack	7cb9f284-8175-4679-b846-145dc604e2c0	2026-06-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valsartan generic name: VALSARTAN
Valsartan	VALSARTAN	Bryant Ranch Prepack	c12db287-786c-47ae-a1f3-df04ddfd2a70	2026-06-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valsartan generic name: VALSARTAN
Valsartan	VALSARTAN	Bryant Ranch Prepack	b3880f58-ce15-4701-84aa-8eb185cf43e2	2026-06-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valsartan generic name: VALSARTAN
Valsartan	VALSARTAN	Bryant Ranch Prepack	7b523502-62b3-425e-960b-f0a58919d3ec	2026-06-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valsartan generic name: VALSARTAN
Valsartan	VALSARTAN	Laurus Labs Limited	6e1f63ad-e554-421b-a699-4e8c9bd4d239	2026-04-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valsartan generic name: VALSARTAN
Valsartan	VALSARTAN	A-S Medication Solutions	0925a24f-6a72-4c77-b4e6-0a8f5b12c8d0	2026-03-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valsartan generic name: VALSARTAN
Valsartan	VALSARTAN	PD-Rx Pharmaceuticals, Inc.	4d6e85d8-7d51-4447-b43d-c2a77f4fe3ae	2026-03-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valsartan generic name: VALSARTAN
Valsartan	VALSARTAN	Camber Pharmaceuticals, Inc.	d6e84105-9394-4ef0-928c-20d07d3fbaa9	2026-02-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valsartan generic name: VALSARTAN
Valsartan	VALSARTAN	A-S Medication Solutions	d9af6ba1-c760-4af6-b733-88e4892d4cb6	2026-01-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valsartan generic name: VALSARTAN
Valsartan	VALSARTAN	AvKARE	a8c61488-4219-dfcb-e053-2a95a90a98a4	2026-01-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valsartan generic name: VALSARTAN
Valsartan	VALSARTAN	Northwind Health Company, LLC	f2b77f2f-333e-f3e3-e053-2a95a90a1fa7	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valsartan generic name: VALSARTAN
Valsartan	VALSARTAN	Northwind Health Company, LLC	f305e9d7-341a-45f6-e053-2a95a90a2d69	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valsartan generic name: VALSARTAN
Valsartan	VALSARTAN	Northwind Health Company, LLC	f756009f-f04f-6518-e053-6294a90a79ed	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valsartan generic name: VALSARTAN
Valsartan	VALSARTAN	Northwind Health Company, LLC	03af7d09-314a-fe85-e063-6294a90afa25	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valsartan generic name: VALSARTAN
valsartan	VALSARTAN	Northwind Health Company, LLC	db4801e5-6e0f-2cb3-e053-2995a90a709a	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: valsartan generic name: VALSARTAN