Application 203536

Type: ANDA
Sponsor: JUBILANT GENERICS

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	TE codes	Approval date
A203536-001	VALSARTAN	VALSARTAN	40MG	TABLET / ORAL	AB	2015-01-05
A203536-002	VALSARTAN	VALSARTAN	80MG	TABLET / ORAL	AB	2015-01-05
A203536-003	VALSARTAN	VALSARTAN	160MG	TABLET / ORAL	AB	2015-01-05
A203536-004	VALSARTAN	VALSARTAN	320MG	TABLET / ORAL	AB	2015-01-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203536-001	AB
A203536-002	AB
A203536-003	AB
A203536-004	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 · 164 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	A203536-001	VALSARTAN	40MG	TABLET / ORAL	AB	2015-01-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203536-002	VALSARTAN	80MG	TABLET / ORAL	AB	2015-01-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203536-003	VALSARTAN	160MG	TABLET / ORAL	AB	2015-01-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203536-004	VALSARTAN	320MG	TABLET / ORAL	AB	2015-01-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203536-001	VALSARTAN	40MG	TABLET / ORAL	AB	2015-01-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203536-002	VALSARTAN	80MG	TABLET / ORAL	AB	2015-01-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203536-003	VALSARTAN	160MG	TABLET / ORAL	AB	2015-01-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203536-004	VALSARTAN	320MG	TABLET / ORAL	AB	2015-01-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203536-001	VALSARTAN	40MG	TABLET / ORAL	AB	2015-01-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203536-002	VALSARTAN	80MG	TABLET / ORAL	AB	2015-01-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203536-003	VALSARTAN	160MG	TABLET / ORAL	AB	2015-01-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203536-004	VALSARTAN	320MG	TABLET / ORAL	AB	2015-01-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203536-001	VALSARTAN	40MG	TABLET / ORAL	AB	2015-01-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203536-002	VALSARTAN	80MG	TABLET / ORAL	AB	2015-01-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203536-003	VALSARTAN	160MG	TABLET / ORAL	AB	2015-01-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203536-004	VALSARTAN	320MG	TABLET / ORAL	AB	2015-01-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203536-001	VALSARTAN	40MG	TABLET / ORAL	AB	2015-01-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203536-002	VALSARTAN	80MG	TABLET / ORAL	AB	2015-01-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203536-003	VALSARTAN	160MG	TABLET / ORAL	AB	2015-01-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203536-004	VALSARTAN	320MG	TABLET / ORAL	AB	2015-01-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203536-001	VALSARTAN	40MG	TABLET / ORAL	AB	2015-01-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203536-002	VALSARTAN	80MG	TABLET / ORAL	AB	2015-01-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203536-003	VALSARTAN	160MG	TABLET / ORAL	AB	2015-01-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203536-004	VALSARTAN	320MG	TABLET / ORAL	AB	2015-01-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203536-001	VALSARTAN	40MG	TABLET / ORAL	AB	2015-01-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203536-002	VALSARTAN	80MG	TABLET / ORAL	AB	2015-01-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203536-003	VALSARTAN	160MG	TABLET / ORAL	AB	2015-01-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203536-004	VALSARTAN	320MG	TABLET / ORAL	AB	2015-01-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203536-001	VALSARTAN	40MG	TABLET / ORAL	AB	2015-01-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203536-002	VALSARTAN	80MG	TABLET / ORAL	AB	2015-01-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203536-003	VALSARTAN	160MG	TABLET / ORAL	AB	2015-01-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203536-004	VALSARTAN	320MG	TABLET / ORAL	AB	2015-01-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203536-001	VALSARTAN	40MG	TABLET / ORAL	AB	2015-01-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203536-002	VALSARTAN	80MG	TABLET / ORAL	AB	2015-01-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203536-003	VALSARTAN	160MG	TABLET / ORAL	AB	2015-01-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203536-004	VALSARTAN	320MG	TABLET / ORAL	AB	2015-01-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203536-001	VALSARTAN	40MG	TABLET / ORAL	AB	2015-01-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203536-002	VALSARTAN	80MG	TABLET / ORAL	AB	2015-01-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203536-003	VALSARTAN	160MG	TABLET / ORAL	AB	2015-01-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203536-004	VALSARTAN	320MG	TABLET / ORAL	AB	2015-01-05	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203536-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203536-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203536-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203536-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203536-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203536-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203536-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203536-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203536-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203536-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203536-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203536-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203536-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203536-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203536-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203536-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203536-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203536-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203536-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203536-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203536-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203536-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203536-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203536-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203536-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203536-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203536-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203536-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203536-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203536-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203536-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203536-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203536-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203536-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203536-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203536-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203536-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203536-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203536-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203536-004	AB	1	`d06236e962d9…`

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
valsartan	VALSARTAN	Northwind Health Company, LLC	db4801e5-6e0f-2cb3-e053-2995a90a709a	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203536 application number: ANDA203536
valsartan	VALSARTAN	PD-Rx Pharmaceuticals, Inc.	5afd7c3d-c66b-479c-bfd0-6c04658b157d	2025-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203536 application number: ANDA203536 ndc (product): 72789-281
valsartan	VALSARTAN	Jubilant Cadista Pharmacuticals Inc.	9402b022-5809-4251-dfef-54f6ef5723fe	2025-02-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203536 application number: ANDA203536 ndc (product): 59746-362 ndc (product): 59746-363 ndc (product): 59746-360 ndc (product): 59746-361
valsartan	VALSARTAN	A-S Medication Solutions	80987771-ccb4-4a9f-a395-0af4c2621e0a	2023-02-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203536 application number: ANDA203536 ndc (product): 50090-5192
valsartan	VALSARTAN	A-S Medication Solutions	e352db8b-0485-492a-8734-0a415566d764	2023-02-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203536 application number: ANDA203536 ndc (product): 50090-5191
valsartan	VALSARTAN	A-S Medication Solutions	9f5a400f-9cfc-4d25-a677-73cbb14375e2	2023-02-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203536 application number: ANDA203536 ndc (product): 50090-5190

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
45865-101	valsartan	valsartan	Medsource Pharmaceuticals	ANDA	Current
50090-5190	valsartan	valsartan	A-S Medication Solutions	ANDA	Current
50090-5190	valsartan	valsartan	A-S Medication Solutions	ANDA	Current
50090-5191	valsartan	valsartan	A-S Medication Solutions	ANDA	Current
50090-5191	valsartan	valsartan	A-S Medication Solutions	ANDA	Current
50090-5192	valsartan	valsartan	A-S Medication Solutions	ANDA	Current
50090-5192	valsartan	valsartan	A-S Medication Solutions	ANDA	Current
59746-360	valsartan	valsartan	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current
59746-360	valsartan	valsartan	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current
59746-360	valsartan	valsartan	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current
59746-361	valsartan	valsartan	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current
59746-361	valsartan	valsartan	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current
59746-361	valsartan	valsartan	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current
59746-362	valsartan	valsartan	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current
59746-362	valsartan	valsartan	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current
59746-362	valsartan	valsartan	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current
59746-363	valsartan	valsartan	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current
59746-363	valsartan	valsartan	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current
59746-363	valsartan	valsartan	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current
70934-270	valsartan	valsartan	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-270	valsartan	valsartan	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
72789-281	valsartan	valsartan	PD-Rx Pharmaceuticals, Inc.	ANDA	Current