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 43.

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 · 56 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
2026-09-14 22:38:34	2026-08	A218169-001	VALSARTAN	40MG	TABLET / ORAL		2024-08-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218169-002	VALSARTAN	80MG	TABLET / ORAL		2024-08-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218169-003	VALSARTAN	160MG	TABLET / ORAL		2024-08-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218169-004	VALSARTAN	320MG	TABLET / ORAL		2024-08-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A218169-001	VALSARTAN	40MG	TABLET / ORAL		2024-08-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218169-002	VALSARTAN	80MG	TABLET / ORAL		2024-08-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218169-003	VALSARTAN	160MG	TABLET / ORAL		2024-08-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218169-004	VALSARTAN	320MG	TABLET / ORAL		2024-08-05	`caaa826d4ba7…`
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…`

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 2 of 4 · 63 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
Valsartan	VALSARTAN	Ascend Laboratories, LLC	7b4ecaf9-e84c-4660-9cd1-65a238efd8a8	2025-12-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valsartan generic name: VALSARTAN
Valsartan	VALSARTAN	Coupler LLC	3eee9505-ebba-76e3-e063-6294a90acd6e	2025-09-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valsartan generic name: VALSARTAN
Valsartan	VALSARTAN	Coupler LLC	3dfe5407-96a6-d2f4-e063-6294a90aa810	2025-09-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valsartan generic name: VALSARTAN
Valsartan	VALSARTAN	Solco Healthcare US, LLC	26080940-bcd3-446d-9026-3ddfb58e281e	2025-08-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valsartan generic name: VALSARTAN
Valsartan	VALSARTAN	Dr. Reddy's Laboratories Limited	75235313-8a07-8849-9b5a-12887992033e	2025-08-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valsartan generic name: VALSARTAN
Valsartan	VALSARTAN ORAL	Advagen Pharma Ltd	47137b1a-f2b0-49af-99f0-6fb4f5a16578	2025-06-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valsartan
valsartan	VALSARTAN	PD-Rx Pharmaceuticals, Inc.	5afd7c3d-c66b-479c-bfd0-6c04658b157d	2025-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: valsartan generic name: VALSARTAN
Valsartan	VALSARTAN	Proficient Rx LP	f59f71d3-c143-43e5-ac22-0b1d741f4a81	2025-02-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valsartan generic name: VALSARTAN
VALSARTAN	VALSARTAN	Direct_Rx	946692f5-0fe2-89b7-e053-2995a90a4d91	2025-01-27	Warnings, Adverse reactions	Name fallback brand name: VALSARTAN generic name: VALSARTAN
Valsartan	VALSARTAN	Camber Pharmaceuticals, Inc.	0ff36e83-b307-42db-a2ab-bae3f6805c20	2025-01-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valsartan generic name: VALSARTAN
Valsartan	VALSARTAN	AvPAK	0878f27e-5368-c93f-e063-6394a90a1086	2025-01-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valsartan generic name: VALSARTAN
Valsartan	VALSARTAN	A-S Medication Solutions	2847db2a-fcc9-4776-875a-ba6d57d5ea8b	2024-10-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valsartan generic name: VALSARTAN
Valsartan	VALSARTAN	American Health Packaging	7ea2fdf1-4fda-47a7-8110-62fb6468c989	2024-09-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valsartan generic name: VALSARTAN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.