Application 202696

Type: ANDA
Sponsor: MACLEODS PHARMS LTD

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
A202696-001	VALSARTAN	VALSARTAN	40MG	TABLET / ORAL	AB	2016-09-16
A202696-002	VALSARTAN	VALSARTAN	80MG	TABLET / ORAL	AB	2016-09-16
A202696-003	VALSARTAN	VALSARTAN	160MG	TABLET / ORAL	AB	2016-09-16
A202696-004	VALSARTAN	VALSARTAN	320MG	TABLET / ORAL	AB	2016-09-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202696-001	AB
A202696-002	AB
A202696-003	AB
A202696-004	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	A202696-001	VALSARTAN	40MG	TABLET / ORAL	AB	2016-09-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202696-002	VALSARTAN	80MG	TABLET / ORAL	AB	2016-09-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202696-003	VALSARTAN	160MG	TABLET / ORAL	AB	2016-09-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202696-004	VALSARTAN	320MG	TABLET / ORAL	AB	2016-09-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202696-001	VALSARTAN	40MG	TABLET / ORAL	AB	2016-09-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202696-002	VALSARTAN	80MG	TABLET / ORAL	AB	2016-09-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202696-003	VALSARTAN	160MG	TABLET / ORAL	AB	2016-09-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202696-004	VALSARTAN	320MG	TABLET / ORAL	AB	2016-09-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202696-001	VALSARTAN	40MG	TABLET / ORAL	AB	2016-09-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202696-002	VALSARTAN	80MG	TABLET / ORAL	AB	2016-09-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202696-003	VALSARTAN	160MG	TABLET / ORAL	AB	2016-09-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202696-004	VALSARTAN	320MG	TABLET / ORAL	AB	2016-09-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202696-001	VALSARTAN	40MG	TABLET / ORAL	AB	2016-09-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202696-002	VALSARTAN	80MG	TABLET / ORAL	AB	2016-09-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202696-003	VALSARTAN	160MG	TABLET / ORAL	AB	2016-09-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202696-004	VALSARTAN	320MG	TABLET / ORAL	AB	2016-09-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202696-001	VALSARTAN	40MG	TABLET / ORAL	AB	2016-09-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202696-002	VALSARTAN	80MG	TABLET / ORAL	AB	2016-09-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202696-003	VALSARTAN	160MG	TABLET / ORAL	AB	2016-09-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202696-004	VALSARTAN	320MG	TABLET / ORAL	AB	2016-09-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202696-001	VALSARTAN	40MG	TABLET / ORAL	AB	2016-09-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202696-002	VALSARTAN	80MG	TABLET / ORAL	AB	2016-09-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202696-003	VALSARTAN	160MG	TABLET / ORAL	AB	2016-09-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202696-004	VALSARTAN	320MG	TABLET / ORAL	AB	2016-09-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202696-001	VALSARTAN	40MG	TABLET / ORAL	AB	2016-09-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202696-002	VALSARTAN	80MG	TABLET / ORAL	AB	2016-09-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202696-003	VALSARTAN	160MG	TABLET / ORAL	AB	2016-09-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202696-004	VALSARTAN	320MG	TABLET / ORAL	AB	2016-09-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202696-001	VALSARTAN	40MG	TABLET / ORAL	AB	2016-09-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202696-002	VALSARTAN	80MG	TABLET / ORAL	AB	2016-09-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202696-003	VALSARTAN	160MG	TABLET / ORAL	AB	2016-09-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202696-004	VALSARTAN	320MG	TABLET / ORAL	AB	2016-09-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202696-001	VALSARTAN	40MG	TABLET / ORAL	AB	2016-09-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202696-002	VALSARTAN	80MG	TABLET / ORAL	AB	2016-09-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202696-003	VALSARTAN	160MG	TABLET / ORAL	AB	2016-09-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202696-004	VALSARTAN	320MG	TABLET / ORAL	AB	2016-09-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202696-001	VALSARTAN	40MG	TABLET / ORAL	AB	2016-09-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202696-002	VALSARTAN	80MG	TABLET / ORAL	AB	2016-09-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202696-003	VALSARTAN	160MG	TABLET / ORAL	AB	2016-09-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202696-004	VALSARTAN	320MG	TABLET / ORAL	AB	2016-09-16	`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	A202696-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202696-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202696-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202696-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202696-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202696-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202696-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202696-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202696-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202696-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202696-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202696-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202696-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202696-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202696-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202696-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202696-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202696-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202696-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202696-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202696-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202696-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202696-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202696-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202696-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202696-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202696-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202696-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202696-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202696-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202696-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202696-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202696-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202696-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202696-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202696-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202696-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202696-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202696-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202696-004	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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Valsartan	VALSARTAN	Macleods Pharmaceuticals Limited	251ccff4-bf86-453b-9d1c-e3c1ecfd3a46	2026-08-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202696 application number: ANDA202696 ndc (product): 33342-063 ndc (product): 33342-065 ndc (product): 33342-064 ndc (product): 33342-062
Valsartan	VALSARTAN	A-S Medication Solutions	bb3c66a7-d397-4df5-822f-4a1f797f54fc	2026-07-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202696 application number: ANDA202696 ndc (product): 50090-4130
Valsartan	VALSARTAN	Northwind Health Company, LLC	f305e9d7-341a-45f6-e053-2a95a90a2d69	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202696 application number: ANDA202696
VALSARTAN	VALSARTAN	Direct_Rx	946692f5-0fe2-89b7-e053-2995a90a4d91	2025-01-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202696 application number: ANDA202696 ndc (product): 72189-049
Valsartan	VALSARTAN	Proficient Rx LP	fadb25bb-acd9-4aaf-971c-82259b739e5b	2022-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202696 application number: ANDA202696 ndc (product): 71205-301

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 55 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
33342-062	Valsartan	Valsartan	Macleods Pharmaceuticals Limited	ANDA	Current
33342-062	Valsartan	Valsartan	Macleods Pharmaceuticals Limited	ANDA	Current
33342-062	Valsartan	Valsartan	Macleods Pharmaceuticals Limited	ANDA	Current
33342-062	Valsartan	Valsartan	Macleods Pharmaceuticals Limited	ANDA	Current
33342-062	Valsartan	Valsartan	Macleods Pharmaceuticals	ANDA	Current
33342-062	Valsartan	Valsartan	Macleods Pharmaceuticals Limited	ANDA	Current
33342-062	Valsartan	Valsartan	Macleods Pharmaceuticals Limited	ANDA	Current
33342-063	Valsartan	Valsartan	Macleods Pharmaceuticals Limited	ANDA	Current
33342-063	Valsartan	Valsartan	Macleods Pharmaceuticals Limited	ANDA	Current
33342-063	Valsartan	Valsartan	Macleods Pharmaceuticals Limited	ANDA	Current
33342-063	Valsartan	Valsartan	Macleods Pharmaceuticals Limited	ANDA	Current
33342-063	Valsartan	Valsartan	Macleods Pharmaceuticals	ANDA	Current
33342-063	Valsartan	Valsartan	Macleods Pharmaceuticals Limited	ANDA	Current
33342-063	Valsartan	Valsartan	Macleods Pharmaceuticals Limited	ANDA	Current
33342-064	Valsartan	Valsartan	Macleods Pharmaceuticals Limited	ANDA	Current
33342-064	Valsartan	Valsartan	Macleods Pharmaceuticals Limited	ANDA	Current
33342-064	Valsartan	Valsartan	Macleods Pharmaceuticals Limited	ANDA	Current
33342-064	Valsartan	Valsartan	Macleods Pharmaceuticals Limited	ANDA	Current
33342-064	Valsartan	Valsartan	Macleods Pharmaceuticals	ANDA	Current
33342-064	Valsartan	Valsartan	Macleods Pharmaceuticals Limited	ANDA	Current
33342-064	Valsartan	Valsartan	Macleods Pharmaceuticals Limited	ANDA	Current
33342-065	Valsartan	Valsartan	Macleods Pharmaceuticals Limited	ANDA	Current
33342-065	Valsartan	Valsartan	Macleods Pharmaceuticals Limited	ANDA	Current
33342-065	Valsartan	Valsartan	Macleods Pharmaceuticals Limited	ANDA	Current
33342-065	Valsartan	Valsartan	Macleods Pharmaceuticals Limited	ANDA	Current
33342-065	Valsartan	Valsartan	Macleods Pharmaceuticals	ANDA	Current
33342-065	Valsartan	Valsartan	Macleods Pharmaceuticals Limited	ANDA	Current
33342-065	Valsartan	Valsartan	Macleods Pharmaceuticals Limited	ANDA	Current
50090-4130	Valsartan	Valsartan	A-S Medication Solutions	ANDA	Current
50090-4130	Valsartan	Valsartan	A-S Medication Solutions	ANDA	Current
50090-4130	Valsartan	Valsartan	A-S Medication Solutions	ANDA	Current
50090-4130	Valsartan	Valsartan	A-S Medication Solutions	ANDA	Current
50090-4824	Valsartan	Valsartan	A-S Medication Solutions	ANDA	Current
50090-4824	Valsartan	Valsartan	A-S Medication Solutions	ANDA	Current
50090-4837	Valsartan	Valsartan	A-S Medication Solutions	ANDA	Current
50090-4837	Valsartan	Valsartan	A-S Medication Solutions	ANDA	Current
63629-7432	Valsartan	Valsartan	Bryant Ranch Prepack	ANDA	Current
63629-7432	Valsartan	Valsartan	Bryant Ranch Prepack	ANDA	Current
63629-7432	Valsartan	Valsartan	Bryant Ranch Prepack	ANDA	Current
70518-1279	Valsartan	Valsartan	REMEDYREPACK INC.	ANDA	Current
70518-1279	Valsartan	Valsartan	REMEDYREPACK INC.	ANDA	Current
71205-301	Valsartan	Valsartan	Proficient Rx LP	ANDA	Current
71205-301	Valsartan	Valsartan	Proficient Rx LP	ANDA	Current
71205-301	Valsartan	Valsartan	Proficient Rx LP	ANDA	Current
71335-0097	Valsartan	Valsartan	Bryant Ranch Prepack	ANDA	Current
71335-0097	Valsartan	Valsartan	Bryant Ranch Prepack	ANDA	Current
71335-0097	Valsartan	Valsartan	Bryant Ranch Prepack	ANDA	Current
71335-0097	Valsartan	Valsartan	Bryant Ranch Prepack	ANDA	Current
71335-0488	Valsartan	Valsartan	Bryant Ranch Prepack	ANDA	Current
71335-0488	Valsartan	Valsartan	Bryant Ranch Prepack	ANDA	Current
71335-0488	Valsartan	Valsartan	Bryant Ranch Prepack	ANDA	Current
71335-0555	Valsartan	Valsartan	Bryant Ranch Prepack	ANDA	Current
72189-049	VALSARTAN	VALSARTAN	Direct_Rx	ANDA	Current
72189-049	VALSARTAN	VALSARTAN	Direct_Rx	ANDA	Current
72189-049	VALSARTAN	VALSARTAN	Direct_Rx	ANDA	Current