Application 204011

Type: ANDA
Sponsor: AMNEAL PHARMS

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 42.

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	TE codes	Approval date
A204011-001	VALSARTAN	VALSARTAN	40MG	TABLET / ORAL	AB	2016-01-11
A204011-002	VALSARTAN	VALSARTAN	80MG	TABLET / ORAL	AB	2016-01-11
A204011-003	VALSARTAN	VALSARTAN	160MG	TABLET / ORAL	AB	2016-01-11
A204011-004	VALSARTAN	VALSARTAN	320MG	TABLET / ORAL	AB	2016-01-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A204011-001	AB
A204011-002	AB
A204011-003	AB
A204011-004	AB

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 5 · 168 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
2026-08-18 06:07:40	2026-07	A204011-001	VALSARTAN	40MG	TABLET / ORAL	AB	2016-01-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204011-002	VALSARTAN	80MG	TABLET / ORAL	AB	2016-01-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204011-003	VALSARTAN	160MG	TABLET / ORAL	AB	2016-01-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204011-004	VALSARTAN	320MG	TABLET / ORAL	AB	2016-01-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204011-001	VALSARTAN	40MG	TABLET / ORAL	AB	2016-01-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204011-002	VALSARTAN	80MG	TABLET / ORAL	AB	2016-01-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204011-003	VALSARTAN	160MG	TABLET / ORAL	AB	2016-01-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204011-004	VALSARTAN	320MG	TABLET / ORAL	AB	2016-01-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204011-001	VALSARTAN	40MG	TABLET / ORAL	AB	2016-01-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204011-002	VALSARTAN	80MG	TABLET / ORAL	AB	2016-01-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204011-003	VALSARTAN	160MG	TABLET / ORAL	AB	2016-01-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204011-004	VALSARTAN	320MG	TABLET / ORAL	AB	2016-01-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204011-001	VALSARTAN	40MG	TABLET / ORAL	AB	2016-01-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204011-002	VALSARTAN	80MG	TABLET / ORAL	AB	2016-01-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204011-003	VALSARTAN	160MG	TABLET / ORAL	AB	2016-01-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204011-004	VALSARTAN	320MG	TABLET / ORAL	AB	2016-01-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204011-001	VALSARTAN	40MG	TABLET / ORAL	AB	2016-01-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204011-002	VALSARTAN	80MG	TABLET / ORAL	AB	2016-01-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204011-003	VALSARTAN	160MG	TABLET / ORAL	AB	2016-01-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204011-004	VALSARTAN	320MG	TABLET / ORAL	AB	2016-01-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204011-001	VALSARTAN	40MG	TABLET / ORAL	AB	2016-01-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204011-002	VALSARTAN	80MG	TABLET / ORAL	AB	2016-01-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204011-003	VALSARTAN	160MG	TABLET / ORAL	AB	2016-01-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204011-004	VALSARTAN	320MG	TABLET / ORAL	AB	2016-01-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204011-001	VALSARTAN	40MG	TABLET / ORAL	AB	2016-01-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204011-002	VALSARTAN	80MG	TABLET / ORAL	AB	2016-01-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204011-003	VALSARTAN	160MG	TABLET / ORAL	AB	2016-01-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204011-004	VALSARTAN	320MG	TABLET / ORAL	AB	2016-01-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204011-001	VALSARTAN	40MG	TABLET / ORAL	AB	2016-01-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204011-002	VALSARTAN	80MG	TABLET / ORAL	AB	2016-01-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204011-003	VALSARTAN	160MG	TABLET / ORAL	AB	2016-01-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204011-004	VALSARTAN	320MG	TABLET / ORAL	AB	2016-01-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204011-001	VALSARTAN	40MG	TABLET / ORAL	AB	2016-01-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204011-002	VALSARTAN	80MG	TABLET / ORAL	AB	2016-01-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204011-003	VALSARTAN	160MG	TABLET / ORAL	AB	2016-01-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204011-004	VALSARTAN	320MG	TABLET / ORAL	AB	2016-01-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204011-001	VALSARTAN	40MG	TABLET / ORAL	AB	2016-01-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204011-002	VALSARTAN	80MG	TABLET / ORAL	AB	2016-01-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204011-003	VALSARTAN	160MG	TABLET / ORAL	AB	2016-01-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204011-004	VALSARTAN	320MG	TABLET / ORAL	AB	2016-01-11	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A204011-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204011-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204011-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204011-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204011-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204011-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204011-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204011-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204011-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204011-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204011-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204011-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204011-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204011-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204011-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204011-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204011-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204011-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204011-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204011-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204011-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204011-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204011-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204011-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204011-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204011-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204011-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204011-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204011-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204011-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204011-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204011-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204011-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204011-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204011-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204011-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204011-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204011-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204011-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204011-004	AB	1	`d8e5a09893c0…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Valsartan	VALSARTAN	AvKARE	a8c61488-4219-dfcb-e053-2a95a90a98a4	2026-01-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204011 application number: ANDA204011 ndc (product): 42291-856 ndc (product): 42291-857 ndc (product): 42291-858 ndc (product): 42291-859
Valsartan	VALSARTAN	Amneal Pharmaceuticals of New York LLC	f13587f8-76cb-49ad-9291-5907249d6b8e	2023-12-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204011 application number: ANDA204011
Valsartan	VALSARTAN	Amneal Pharmaceuticals LLC	f4a5df78-157b-4996-845c-235234250f11	2023-08-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204011 application number: ANDA204011 ndc (product): 65162-838 ndc (product): 65162-840 ndc (product): 65162-837 ndc (product): 65162-839

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 38 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42291-856	Valsartan	Valsartan	AvKARE	ANDA	Current
42291-856	Valsartan	Valsartan	AvKARE	ANDA	Current
42291-857	Valsartan	Valsartan	AvKARE	ANDA	Current
42291-857	Valsartan	Valsartan	AvKARE	ANDA	Current
42291-858	Valsartan	Valsartan	AvKARE	ANDA	Current
42291-858	Valsartan	Valsartan	AvKARE	ANDA	Current
42291-859	Valsartan	Valsartan	AvKARE	ANDA	Current
42291-859	Valsartan	Valsartan	AvKARE	ANDA	Current
65162-837	Valsartan	Valsartan	Amneal Pharmaceuticals LLC	ANDA	Current
65162-837	Valsartan	Valsartan	Amneal Pharmaceuticals LLC	ANDA	Current
65162-837	Valsartan	Valsartan	Amneal Pharmaceuticals LLC	ANDA	Current
65162-837	Valsartan	Valsartan	Amneal Pharmaceuticals LLC	ANDA	Current
65162-837	Valsartan	Valsartan	Amneal Pharmaceuticals LLC	ANDA	Current
65162-837	Valsartan	Valsartan	Amneal Pharmaceuticals LLC	ANDA	Current
65162-837	Valsartan	Valsartan	Amneal Pharmaceuticals LLC	ANDA	Current
65162-838	Valsartan	Valsartan	Amneal Pharmaceuticals LLC	ANDA	Current
65162-838	Valsartan	Valsartan	Amneal Pharmaceuticals LLC	ANDA	Current
65162-838	Valsartan	Valsartan	Amneal Pharmaceuticals LLC	ANDA	Current
65162-838	Valsartan	Valsartan	Amneal Pharmaceuticals LLC	ANDA	Current
65162-838	Valsartan	Valsartan	Amneal Pharmaceuticals LLC	ANDA	Current
65162-838	Valsartan	Valsartan	Amneal Pharmaceuticals LLC	ANDA	Current
65162-838	Valsartan	Valsartan	Amneal Pharmaceuticals LLC	ANDA	Current
65162-839	Valsartan	Valsartan	Amneal Pharmaceuticals LLC	ANDA	Current
65162-839	Valsartan	Valsartan	Amneal Pharmaceuticals LLC	ANDA	Current
65162-839	Valsartan	Valsartan	Amneal Pharmaceuticals LLC	ANDA	Current
65162-839	Valsartan	Valsartan	Amneal Pharmaceuticals LLC	ANDA	Current
65162-839	Valsartan	Valsartan	Amneal Pharmaceuticals LLC	ANDA	Current
65162-839	Valsartan	Valsartan	Amneal Pharmaceuticals LLC	ANDA	Current
65162-839	Valsartan	Valsartan	Amneal Pharmaceuticals LLC	ANDA	Current
65162-840	Valsartan	Valsartan	Amneal Pharmaceuticals LLC	ANDA	Current
65162-840	Valsartan	Valsartan	Amneal Pharmaceuticals LLC	ANDA	Current
65162-840	Valsartan	Valsartan	Amneal Pharmaceuticals LLC	ANDA	Current
65162-840	Valsartan	Valsartan	Amneal Pharmaceuticals LLC	ANDA	Current
65162-840	Valsartan	Valsartan	Amneal Pharmaceuticals LLC	ANDA	Current
65162-840	Valsartan	Valsartan	Amneal Pharmaceuticals LLC	ANDA	Current
65162-840	Valsartan	Valsartan	Amneal Pharmaceuticals LLC	ANDA	Current
70934-293	Valsartan	Valsartan	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-293	Valsartan	Valsartan	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current