Application 204821

Type: ANDA
Sponsor: PRINSTON INC

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
A204821-001	VALSARTAN	VALSARTAN	40MG	TABLET / ORAL	AB	2015-06-09
A204821-002	VALSARTAN	VALSARTAN	80MG	TABLET / ORAL	AB	2015-06-09
A204821-003	VALSARTAN	VALSARTAN	160MG	TABLET / ORAL	AB	2015-06-09
A204821-004	VALSARTAN	VALSARTAN	320MG	TABLET / ORAL	AB	2015-06-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204821-001	AB
A204821-002	AB
A204821-003	AB
A204821-004	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	A204821-001	VALSARTAN	40MG	TABLET / ORAL	AB	2015-06-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204821-002	VALSARTAN	80MG	TABLET / ORAL	AB	2015-06-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204821-003	VALSARTAN	160MG	TABLET / ORAL	AB	2015-06-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204821-004	VALSARTAN	320MG	TABLET / ORAL	AB	2015-06-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204821-001	VALSARTAN	40MG	TABLET / ORAL	AB	2015-06-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204821-002	VALSARTAN	80MG	TABLET / ORAL	AB	2015-06-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204821-003	VALSARTAN	160MG	TABLET / ORAL	AB	2015-06-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204821-004	VALSARTAN	320MG	TABLET / ORAL	AB	2015-06-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204821-001	VALSARTAN	40MG	TABLET / ORAL	AB	2015-06-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204821-002	VALSARTAN	80MG	TABLET / ORAL	AB	2015-06-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204821-003	VALSARTAN	160MG	TABLET / ORAL	AB	2015-06-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204821-004	VALSARTAN	320MG	TABLET / ORAL	AB	2015-06-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204821-001	VALSARTAN	40MG	TABLET / ORAL	AB	2015-06-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204821-002	VALSARTAN	80MG	TABLET / ORAL	AB	2015-06-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204821-003	VALSARTAN	160MG	TABLET / ORAL	AB	2015-06-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204821-004	VALSARTAN	320MG	TABLET / ORAL	AB	2015-06-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204821-001	VALSARTAN	40MG	TABLET / ORAL	AB	2015-06-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204821-002	VALSARTAN	80MG	TABLET / ORAL	AB	2015-06-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204821-003	VALSARTAN	160MG	TABLET / ORAL	AB	2015-06-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204821-004	VALSARTAN	320MG	TABLET / ORAL	AB	2015-06-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204821-001	VALSARTAN	40MG	TABLET / ORAL	AB	2015-06-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204821-002	VALSARTAN	80MG	TABLET / ORAL	AB	2015-06-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204821-003	VALSARTAN	160MG	TABLET / ORAL	AB	2015-06-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204821-004	VALSARTAN	320MG	TABLET / ORAL	AB	2015-06-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204821-001	VALSARTAN	40MG	TABLET / ORAL	AB	2015-06-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204821-002	VALSARTAN	80MG	TABLET / ORAL	AB	2015-06-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204821-003	VALSARTAN	160MG	TABLET / ORAL	AB	2015-06-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204821-004	VALSARTAN	320MG	TABLET / ORAL	AB	2015-06-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204821-001	VALSARTAN	40MG	TABLET / ORAL	AB	2015-06-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204821-002	VALSARTAN	80MG	TABLET / ORAL	AB	2015-06-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204821-003	VALSARTAN	160MG	TABLET / ORAL	AB	2015-06-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204821-004	VALSARTAN	320MG	TABLET / ORAL	AB	2015-06-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204821-001	VALSARTAN	40MG	TABLET / ORAL	AB	2015-06-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204821-002	VALSARTAN	80MG	TABLET / ORAL	AB	2015-06-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204821-003	VALSARTAN	160MG	TABLET / ORAL	AB	2015-06-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204821-004	VALSARTAN	320MG	TABLET / ORAL	AB	2015-06-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204821-001	VALSARTAN	40MG	TABLET / ORAL	AB	2015-06-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204821-002	VALSARTAN	80MG	TABLET / ORAL	AB	2015-06-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204821-003	VALSARTAN	160MG	TABLET / ORAL	AB	2015-06-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204821-004	VALSARTAN	320MG	TABLET / ORAL	AB	2015-06-09	`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	A204821-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204821-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204821-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204821-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204821-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204821-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204821-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204821-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204821-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204821-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204821-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204821-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204821-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204821-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204821-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204821-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204821-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204821-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204821-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204821-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204821-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204821-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204821-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204821-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204821-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204821-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204821-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204821-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204821-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204821-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204821-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204821-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204821-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204821-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204821-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204821-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204821-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204821-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204821-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204821-004	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 · 9 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	Exact identifier application applno (ANDA): 204821 application number: ANDA204821 ndc (product): 50090-2424 ndc (product): 50090-3108
Valsartan	VALSARTAN	Northwind Health Company, LLC	03af7d09-314a-fe85-e063-6294a90afa25	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204821 application number: ANDA204821
Valsartan	VALSARTAN	Solco Healthcare US, LLC	26080940-bcd3-446d-9026-3ddfb58e281e	2025-08-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204821 application number: ANDA204821 ndc (product): 43547-368 ndc (product): 43547-367 ndc (product): 43547-370 ndc (product): 43547-369
Valsartan	VALSARTAN	A-S Medication Solutions	2847db2a-fcc9-4776-875a-ba6d57d5ea8b	2024-10-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204821 application number: ANDA204821
Valsartan	VALSARTAN	Bryant Ranch Prepack	d9a16816-d4de-401a-8413-7233f4e541f8	2024-01-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204821 application number: ANDA204821 ndc (product): 71335-0475
Valsartan	VALSARTAN	Bryant Ranch Prepack	e8fcd4c2-8baa-452a-b723-5cb3d8d203a9	2023-12-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204821 application number: ANDA204821
Valsartan	VALSARTAN	Bryant Ranch Prepack	4e160647-a08e-40e8-b566-3e97a09c616a	2023-11-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204821 application number: ANDA204821 ndc (product): 71335-0567
Valsartan	VALSARTAN	Bryant Ranch Prepack	bcbd44f6-d49a-4a59-bba5-70fb843d1f59	2023-09-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204821 application number: ANDA204821
Valsartan	VALSARTAN	Proficient Rx LP	b58471fe-e2c6-4cc5-9d49-6a3111f6e002	2021-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204821 application number: ANDA204821 ndc (product): 63187-655

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 23 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43547-367	Valsartan	valsartan	Solco Healthcare US, LLC	ANDA	Current
43547-367	Valsartan	valsartan	Solco Healthcare US, LLC	ANDA	Current
43547-367	Valsartan	valsartan	Solco Healthcare US, LLC	ANDA	Current
43547-368	Valsartan	valsartan	Solco Healthcare US, LLC	ANDA	Current
43547-368	Valsartan	valsartan	Solco Healthcare US, LLC	ANDA	Current
43547-368	Valsartan	valsartan	Solco Healthcare US, LLC	ANDA	Current
43547-369	Valsartan	valsartan	Solco Healthcare US, LLC	ANDA	Current
43547-369	Valsartan	valsartan	Solco Healthcare US, LLC	ANDA	Current
43547-369	Valsartan	valsartan	Solco Healthcare US, LLC	ANDA	Current
43547-370	Valsartan	valsartan	Solco Healthcare US, LLC	ANDA	Current
43547-370	Valsartan	valsartan	Solco Healthcare US, LLC	ANDA	Current
43547-370	Valsartan	valsartan	Solco Healthcare US, LLC	ANDA	Current
50090-2424	Valsartan	valsartan	A-S Medication Solutions	ANDA	Current
50090-3108	Valsartan	valsartan	A-S Medication Solutions	ANDA	Current
55700-346	Valsartan	valsartan	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-347	Valsartan	valsartan	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
63187-655	Valsartan	valsartan	Proficient Rx LP	ANDA	Current
63187-655	Valsartan	valsartan	Proficient Rx LP	ANDA	Current
71335-0475	Valsartan	valsartan	Bryant Ranch Prepack	ANDA	Current
71335-0475	Valsartan	valsartan	Bryant Ranch Prepack	ANDA	Current
71335-0475	Valsartan	valsartan	Bryant Ranch Prepack	ANDA	Current
71335-0567	Valsartan	valsartan	Bryant Ranch Prepack	ANDA	Current
71335-0567	Valsartan	valsartan	Bryant Ranch Prepack	ANDA	Current