Application 091367

Type: ANDA
Sponsor: ALEMBIC 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 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
A091367-001	VALSARTAN	VALSARTAN	40MG	TABLET / ORAL	AB	2015-01-05
A091367-002	VALSARTAN	VALSARTAN	80MG	TABLET / ORAL	AB	2015-01-05
A091367-003	VALSARTAN	VALSARTAN	160MG	TABLET / ORAL	AB	2015-01-05
A091367-004	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
A091367-001	AB
A091367-002	AB
A091367-003	AB
A091367-004	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	A091367-001	VALSARTAN	40MG	TABLET / ORAL	AB	2015-01-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091367-002	VALSARTAN	80MG	TABLET / ORAL	AB	2015-01-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091367-003	VALSARTAN	160MG	TABLET / ORAL	AB	2015-01-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091367-004	VALSARTAN	320MG	TABLET / ORAL	AB	2015-01-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091367-001	VALSARTAN	40MG	TABLET / ORAL	AB	2015-01-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091367-002	VALSARTAN	80MG	TABLET / ORAL	AB	2015-01-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091367-003	VALSARTAN	160MG	TABLET / ORAL	AB	2015-01-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091367-004	VALSARTAN	320MG	TABLET / ORAL	AB	2015-01-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091367-001	VALSARTAN	40MG	TABLET / ORAL	AB	2015-01-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091367-002	VALSARTAN	80MG	TABLET / ORAL	AB	2015-01-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091367-003	VALSARTAN	160MG	TABLET / ORAL	AB	2015-01-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091367-004	VALSARTAN	320MG	TABLET / ORAL	AB	2015-01-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091367-001	VALSARTAN	40MG	TABLET / ORAL	AB	2015-01-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091367-002	VALSARTAN	80MG	TABLET / ORAL	AB	2015-01-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091367-003	VALSARTAN	160MG	TABLET / ORAL	AB	2015-01-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091367-004	VALSARTAN	320MG	TABLET / ORAL	AB	2015-01-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091367-001	VALSARTAN	40MG	TABLET / ORAL	AB	2015-01-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091367-002	VALSARTAN	80MG	TABLET / ORAL	AB	2015-01-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091367-003	VALSARTAN	160MG	TABLET / ORAL	AB	2015-01-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091367-004	VALSARTAN	320MG	TABLET / ORAL	AB	2015-01-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091367-001	VALSARTAN	40MG	TABLET / ORAL	AB	2015-01-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091367-002	VALSARTAN	80MG	TABLET / ORAL	AB	2015-01-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091367-003	VALSARTAN	160MG	TABLET / ORAL	AB	2015-01-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091367-004	VALSARTAN	320MG	TABLET / ORAL	AB	2015-01-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091367-001	VALSARTAN	40MG	TABLET / ORAL	AB	2015-01-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091367-002	VALSARTAN	80MG	TABLET / ORAL	AB	2015-01-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091367-003	VALSARTAN	160MG	TABLET / ORAL	AB	2015-01-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091367-004	VALSARTAN	320MG	TABLET / ORAL	AB	2015-01-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091367-001	VALSARTAN	40MG	TABLET / ORAL	AB	2015-01-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091367-002	VALSARTAN	80MG	TABLET / ORAL	AB	2015-01-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091367-003	VALSARTAN	160MG	TABLET / ORAL	AB	2015-01-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091367-004	VALSARTAN	320MG	TABLET / ORAL	AB	2015-01-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091367-001	VALSARTAN	40MG	TABLET / ORAL	AB	2015-01-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091367-002	VALSARTAN	80MG	TABLET / ORAL	AB	2015-01-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091367-003	VALSARTAN	160MG	TABLET / ORAL	AB	2015-01-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091367-004	VALSARTAN	320MG	TABLET / ORAL	AB	2015-01-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091367-001	VALSARTAN	40MG	TABLET / ORAL	AB	2015-01-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091367-002	VALSARTAN	80MG	TABLET / ORAL	AB	2015-01-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091367-003	VALSARTAN	160MG	TABLET / ORAL	AB	2015-01-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091367-004	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	A091367-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091367-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091367-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091367-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091367-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091367-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091367-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091367-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091367-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091367-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091367-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091367-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091367-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091367-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091367-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091367-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091367-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091367-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091367-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091367-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091367-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091367-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091367-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091367-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091367-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091367-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091367-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091367-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091367-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091367-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091367-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091367-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091367-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091367-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091367-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091367-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091367-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091367-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091367-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091367-004	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Valsartan	VALSARTAN	Alembic Pharmaceuticals Limited	6e2cd953-88bf-4094-8ba8-2c9ba020f4d7	2023-01-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091367 application number: ANDA091367 ndc (product): 46708-044 ndc (product): 46708-047 ndc (product): 46708-045 ndc (product): 46708-046
Valsartan	VALSARTAN	Alembic Pharmaceuticals Inc.	8478a05f-38fd-412d-af49-69a73a787c8f	2021-08-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091367 application number: ANDA091367 ndc (product): 62332-045 ndc (product): 62332-044 ndc (product): 62332-046 ndc (product): 62332-047

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 43 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
45865-114	Valsartan	Valsartan	Medsource Pharmaceuticals	ANDA	Current
46708-044	Valsartan	Valsartan	Alembic Pharmaceuticals Limited	ANDA	Current
46708-044	Valsartan	Valsartan	Alembic Pharmaceuticals Limited	ANDA	Current
46708-044	Valsartan	Valsartan	Alembic Pharmaceuticals Limited	ANDA	Current
46708-045	Valsartan	Valsartan	Alembic Pharmaceuticals Limited	ANDA	Current
46708-045	Valsartan	Valsartan	Alembic Pharmaceuticals Limited	ANDA	Current
46708-045	Valsartan	Valsartan	Alembic Pharmaceuticals Limited	ANDA	Current
46708-046	Valsartan	Valsartan	Alembic Pharmaceuticals Limited	ANDA	Current
46708-046	Valsartan	Valsartan	Alembic Pharmaceuticals Limited	ANDA	Current
46708-046	Valsartan	Valsartan	Alembic Pharmaceuticals Limited	ANDA	Current
46708-047	Valsartan	Valsartan	Alembic Pharmaceuticals Limited	ANDA	Current
46708-047	Valsartan	Valsartan	Alembic Pharmaceuticals Limited	ANDA	Current
46708-047	Valsartan	Valsartan	Alembic Pharmaceuticals Limited	ANDA	Current
62332-044	Valsartan	Valsartan	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-044	Valsartan	Valsartan	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-044	Valsartan	Valsartan	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-044	Valsartan	Valsartan	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-044	Valsartan	Valsartan	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-044	Valsartan	Valsartan	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-045	Valsartan	Valsartan	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-045	Valsartan	Valsartan	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-045	Valsartan	Valsartan	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-045	Valsartan	Valsartan	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-045	Valsartan	Valsartan	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-045	Valsartan	Valsartan	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-046	Valsartan	Valsartan	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-046	Valsartan	Valsartan	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-046	Valsartan	Valsartan	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-046	Valsartan	Valsartan	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-046	Valsartan	Valsartan	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-046	Valsartan	Valsartan	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-047	Valsartan	Valsartan	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-047	Valsartan	Valsartan	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-047	Valsartan	Valsartan	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-047	Valsartan	Valsartan	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-047	Valsartan	Valsartan	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-047	Valsartan	Valsartan	Alembic Pharmaceuticals Inc.	ANDA	Current
71335-1436	Valsartan	Valsartan	Bryant Ranch Prepack	ANDA	Current
71335-1436	Valsartan	Valsartan	Bryant Ranch Prepack	ANDA	Current
71335-1436	Valsartan	Valsartan	Bryant Ranch Prepack	ANDA	Current
71335-1561	Valsartan	Valsartan	Bryant Ranch Prepack	ANDA	Current
71335-1561	Valsartan	Valsartan	Bryant Ranch Prepack	ANDA	Current
72189-050	VALSARTAN	VALSARTAN	Direct_Rx	ANDA	Current