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 3 of 4 · 63 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Valsartan	VALSARTAN	Viona Pharmaceuticals Inc	bd7b35c7-9f01-4afd-b497-bbe0f3d69b29	2024-07-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valsartan generic name: VALSARTAN
Valsartan	VALSARTAN	Zydus Lifesciences Limited	1b60c816-7399-42c3-8b74-4dc9d82873ec	2024-07-23		Name fallback brand name: Valsartan generic name: VALSARTAN
Valsartan	VALSARTAN	Aurobindo Pharma Limited	a81a72dd-e828-4208-af9b-bb9ac4938537	2024-05-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valsartan generic name: VALSARTAN
Valsartan	VALSARTAN	Lupin Pharmaceuticals, Inc.	9eb9d98e-7057-4ca0-91ab-2030bc0120a6	2024-03-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valsartan generic name: VALSARTAN
Valsartan	VALSARTAN	Bryant Ranch Prepack	d9a16816-d4de-401a-8413-7233f4e541f8	2024-01-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valsartan generic name: VALSARTAN
Valsartan	VALSARTAN	Amneal Pharmaceuticals of New York LLC	f13587f8-76cb-49ad-9291-5907249d6b8e	2023-12-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valsartan generic name: VALSARTAN
Valsartan	VALSARTAN	Bryant Ranch Prepack	e8fcd4c2-8baa-452a-b723-5cb3d8d203a9	2023-12-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valsartan generic name: VALSARTAN
Valsartan	VALSARTAN	Bryant Ranch Prepack	4e160647-a08e-40e8-b566-3e97a09c616a	2023-11-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valsartan generic name: VALSARTAN
Valsartan	VALSARTAN	A-S Medication Solutions	688b5c82-2eba-445c-869e-60609f5db86a	2023-10-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valsartan generic name: VALSARTAN
Valsartan	VALSARTAN	Bryant Ranch Prepack	bcbd44f6-d49a-4a59-bba5-70fb843d1f59	2023-09-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valsartan generic name: VALSARTAN
Valsartan	VALSARTAN	ANI Pharmaceuticals, Inc.	959b6790-feb7-45a9-9ea4-0ee1a7fce048	2023-09-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valsartan generic name: VALSARTAN
Valsartan	VALSARTAN	Amneal Pharmaceuticals LLC	f4a5df78-157b-4996-845c-235234250f11	2023-08-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valsartan generic name: VALSARTAN
Valsartan	VALSARTAN	SQUARE PHARMACEUTICALS LIMITED	5ee97546-2a7c-40fa-9e05-b7993a72dfbf	2023-07-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valsartan generic name: VALSARTAN
valsartan	VALSARTAN	A-S Medication Solutions	80987771-ccb4-4a9f-a395-0af4c2621e0a	2023-02-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: valsartan generic name: VALSARTAN
valsartan	VALSARTAN	A-S Medication Solutions	e352db8b-0485-492a-8734-0a415566d764	2023-02-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: valsartan generic name: VALSARTAN
valsartan	VALSARTAN	A-S Medication Solutions	9f5a400f-9cfc-4d25-a677-73cbb14375e2	2023-02-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: valsartan generic name: VALSARTAN
Valsartan	VALSARTAN	A-S Medication Solutions	506ab3dd-c5eb-4755-ad10-bc116f4443c7	2023-01-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valsartan generic name: VALSARTAN
Valsartan	VALSARTAN	Alembic Pharmaceuticals Limited	6e2cd953-88bf-4094-8ba8-2c9ba020f4d7	2023-01-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valsartan generic name: VALSARTAN
Valsartan	VALSARTAN	Proficient Rx LP	fadb25bb-acd9-4aaf-971c-82259b739e5b	2022-11-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valsartan generic name: VALSARTAN
Valsartan	VALSARTAN	Lifsa Drugs LLC	130e1659-9c2d-49ca-9db8-d28aa23fd133	2022-04-07	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.