Application 203311

Type: ANDA
Sponsor: HETERO LABS LTD V

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
A203311-001	VALSARTAN	VALSARTAN	40MG	TABLET / ORAL	AB	2015-01-05
A203311-002	VALSARTAN	VALSARTAN	80MG	TABLET / ORAL	AB	2015-01-05
A203311-003	VALSARTAN	VALSARTAN	160MG	TABLET / ORAL	AB	2015-01-05
A203311-004	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
A203311-001	AB
A203311-002	AB
A203311-003	AB
A203311-004	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	A203311-001	VALSARTAN	40MG	TABLET / ORAL	AB	2015-01-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203311-002	VALSARTAN	80MG	TABLET / ORAL	AB	2015-01-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203311-003	VALSARTAN	160MG	TABLET / ORAL	AB	2015-01-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203311-004	VALSARTAN	320MG	TABLET / ORAL	AB	2015-01-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203311-001	VALSARTAN	40MG	TABLET / ORAL	AB	2015-01-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203311-002	VALSARTAN	80MG	TABLET / ORAL	AB	2015-01-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203311-003	VALSARTAN	160MG	TABLET / ORAL	AB	2015-01-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203311-004	VALSARTAN	320MG	TABLET / ORAL	AB	2015-01-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203311-001	VALSARTAN	40MG	TABLET / ORAL	AB	2015-01-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203311-002	VALSARTAN	80MG	TABLET / ORAL	AB	2015-01-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203311-003	VALSARTAN	160MG	TABLET / ORAL	AB	2015-01-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203311-004	VALSARTAN	320MG	TABLET / ORAL	AB	2015-01-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203311-001	VALSARTAN	40MG	TABLET / ORAL	AB	2015-01-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203311-002	VALSARTAN	80MG	TABLET / ORAL	AB	2015-01-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203311-003	VALSARTAN	160MG	TABLET / ORAL	AB	2015-01-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203311-004	VALSARTAN	320MG	TABLET / ORAL	AB	2015-01-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203311-001	VALSARTAN	40MG	TABLET / ORAL	AB	2015-01-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203311-002	VALSARTAN	80MG	TABLET / ORAL	AB	2015-01-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203311-003	VALSARTAN	160MG	TABLET / ORAL	AB	2015-01-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203311-004	VALSARTAN	320MG	TABLET / ORAL	AB	2015-01-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203311-001	VALSARTAN	40MG	TABLET / ORAL	AB	2015-01-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203311-002	VALSARTAN	80MG	TABLET / ORAL	AB	2015-01-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203311-003	VALSARTAN	160MG	TABLET / ORAL	AB	2015-01-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203311-004	VALSARTAN	320MG	TABLET / ORAL	AB	2015-01-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203311-001	VALSARTAN	40MG	TABLET / ORAL	AB	2015-01-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203311-002	VALSARTAN	80MG	TABLET / ORAL	AB	2015-01-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203311-003	VALSARTAN	160MG	TABLET / ORAL	AB	2015-01-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203311-004	VALSARTAN	320MG	TABLET / ORAL	AB	2015-01-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203311-001	VALSARTAN	40MG	TABLET / ORAL	AB	2015-01-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203311-002	VALSARTAN	80MG	TABLET / ORAL	AB	2015-01-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203311-003	VALSARTAN	160MG	TABLET / ORAL	AB	2015-01-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203311-004	VALSARTAN	320MG	TABLET / ORAL	AB	2015-01-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203311-001	VALSARTAN	40MG	TABLET / ORAL	AB	2015-01-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203311-002	VALSARTAN	80MG	TABLET / ORAL	AB	2015-01-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203311-003	VALSARTAN	160MG	TABLET / ORAL	AB	2015-01-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203311-004	VALSARTAN	320MG	TABLET / ORAL	AB	2015-01-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203311-001	VALSARTAN	40MG	TABLET / ORAL	AB	2015-01-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203311-002	VALSARTAN	80MG	TABLET / ORAL	AB	2015-01-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203311-003	VALSARTAN	160MG	TABLET / ORAL	AB	2015-01-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203311-004	VALSARTAN	320MG	TABLET / ORAL	AB	2015-01-05	`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	A203311-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203311-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203311-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203311-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203311-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203311-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203311-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203311-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203311-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203311-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203311-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203311-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203311-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203311-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203311-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203311-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203311-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203311-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203311-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203311-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203311-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203311-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203311-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203311-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203311-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203311-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203311-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203311-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203311-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203311-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203311-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203311-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203311-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203311-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203311-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203311-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203311-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203311-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203311-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203311-004	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 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Valsartan	VALSARTAN	Northwind Health Company, LLC	04b3301f-e054-ed5d-e063-6294a90a819c	2026-06-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203311 application number: ANDA203311
Valsartan	VALSARTAN	Bryant Ranch Prepack	6e9c4c57-e2c9-461b-9c09-669d3ada4c1a	2026-06-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203311 application number: ANDA203311 ndc (product): 71335-2154
Valsartan	VALSARTAN	Bryant Ranch Prepack	c12db287-786c-47ae-a1f3-df04ddfd2a70	2026-06-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203311 application number: ANDA203311 ndc (product): 71335-2155
Valsartan	VALSARTAN	Bryant Ranch Prepack	b3880f58-ce15-4701-84aa-8eb185cf43e2	2026-06-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203311 application number: ANDA203311 ndc (product): 71335-2151
Valsartan	VALSARTAN	Bryant Ranch Prepack	7b523502-62b3-425e-960b-f0a58919d3ec	2026-06-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203311 application number: ANDA203311 ndc (product): 71335-2152
Valsartan	VALSARTAN	A-S Medication Solutions	0925a24f-6a72-4c77-b4e6-0a8f5b12c8d0	2026-03-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203311 application number: ANDA203311
Valsartan	VALSARTAN	Camber Pharmaceuticals, Inc.	d6e84105-9394-4ef0-928c-20d07d3fbaa9	2026-02-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203311 application number: ANDA203311 ndc (product): 31722-154 ndc (product): 31722-152 ndc (product): 31722-151 ndc (product): 31722-153
Valsartan	VALSARTAN	Northwind Health Company, LLC	f756009f-f04f-6518-e053-6294a90a79ed	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203311 application number: ANDA203311
Valsartan	VALSARTAN	Coupler LLC	3eee9505-ebba-76e3-e063-6294a90acd6e	2025-09-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203311 application number: ANDA203311
Valsartan	VALSARTAN	Coupler LLC	3dfe5407-96a6-d2f4-e063-6294a90aa810	2025-09-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203311 application number: ANDA203311
Valsartan	VALSARTAN	Proficient Rx LP	f59f71d3-c143-43e5-ac22-0b1d741f4a81	2025-02-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203311 application number: ANDA203311
Valsartan	VALSARTAN	Camber Pharmaceuticals, Inc.	0ff36e83-b307-42db-a2ab-bae3f6805c20	2025-01-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203311 application number: ANDA203311 ndc (product): 31722-748 ndc (product): 31722-745 ndc (product): 31722-746 ndc (product): 31722-747
Valsartan	VALSARTAN	AvPAK	0878f27e-5368-c93f-e063-6394a90a1086	2025-01-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203311 application number: ANDA203311
Valsartan	VALSARTAN	A-S Medication Solutions	688b5c82-2eba-445c-869e-60609f5db86a	2023-10-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203311 application number: ANDA203311
Valsartan	VALSARTAN	A-S Medication Solutions	506ab3dd-c5eb-4755-ad10-bc116f4443c7	2023-01-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203311 application number: ANDA203311

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 32 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
31722-151	Valsartan	Valsartan	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-152	Valsartan	Valsartan	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-153	Valsartan	Valsartan	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-154	Valsartan	Valsartan	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-745	Valsartan	Valsartan	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-745	Valsartan	Valsartan	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-746	Valsartan	Valsartan	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-746	Valsartan	Valsartan	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-747	Valsartan	Valsartan	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-747	Valsartan	Valsartan	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-748	Valsartan	Valsartan	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-748	Valsartan	Valsartan	Camber Pharmaceuticals, Inc.	ANDA	Current
50090-2433	Valsartan	Valsartan	A-S Medication Solutions	ANDA	Current
50268-783	Valsartan	Valsartan	AvPAK	ANDA	Current
50268-783	Valsartan	Valsartan	AvPAK	ANDA	Current
50268-783	Valsartan	Valsartan	AvPAK	ANDA	Current
50268-784	Valsartan	Valsartan	AvPAK	ANDA	Current
50268-784	Valsartan	Valsartan	AvPAK	ANDA	Current
50268-784	Valsartan	Valsartan	AvPAK	ANDA	Current
50268-785	Valsartan	Valsartan	AvPAK	ANDA	Current
50268-785	Valsartan	Valsartan	AvPAK	ANDA	Current
50268-785	Valsartan	Valsartan	AvPAK	ANDA	Current
50268-786	Valsartan	Valsartan	AvPAK	ANDA	Current
50268-786	Valsartan	Valsartan	AvPAK	ANDA	Current
50268-786	Valsartan	Valsartan	AvPAK	ANDA	Current
68788-6814	Valsartan	Valsartan	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-6882	Valsartan	Valsartan	Preferred Pharmaceuticals Inc.	ANDA	Current
71335-2151	Valsartan	Valsartan	Bryant Ranch Prepack	ANDA	Current
71335-2152	Valsartan	Valsartan	Bryant Ranch Prepack	ANDA	Current
71335-2154	Valsartan	Valsartan	Bryant Ranch Prepack	ANDA	Current
71335-2154	Valsartan	Valsartan	Bryant Ranch Prepack	ANDA	Current
71335-2155	Valsartan	Valsartan	Bryant Ranch Prepack	ANDA	Current