Application 077492

Type: ANDA
Sponsor: OHM LABS 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 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
A077492-001	VALSARTAN	VALSARTAN	40MG	TABLET / ORAL	AB	2014-06-26
A077492-002	VALSARTAN	VALSARTAN	80MG	TABLET / ORAL	AB	2014-06-26
A077492-003	VALSARTAN	VALSARTAN	160MG	TABLET / ORAL	AB	2014-06-26
A077492-004	VALSARTAN	VALSARTAN	320MG	TABLET / ORAL	AB	2014-06-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077492-001	AB
A077492-002	AB
A077492-003	AB
A077492-004	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	A077492-001	VALSARTAN	40MG	TABLET / ORAL	AB	2014-06-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077492-002	VALSARTAN	80MG	TABLET / ORAL	AB	2014-06-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077492-003	VALSARTAN	160MG	TABLET / ORAL	AB	2014-06-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077492-004	VALSARTAN	320MG	TABLET / ORAL	AB	2014-06-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077492-001	VALSARTAN	40MG	TABLET / ORAL	AB	2014-06-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077492-002	VALSARTAN	80MG	TABLET / ORAL	AB	2014-06-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077492-003	VALSARTAN	160MG	TABLET / ORAL	AB	2014-06-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077492-004	VALSARTAN	320MG	TABLET / ORAL	AB	2014-06-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077492-001	VALSARTAN	40MG	TABLET / ORAL	AB	2014-06-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077492-002	VALSARTAN	80MG	TABLET / ORAL	AB	2014-06-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077492-003	VALSARTAN	160MG	TABLET / ORAL	AB	2014-06-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077492-004	VALSARTAN	320MG	TABLET / ORAL	AB	2014-06-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077492-001	VALSARTAN	40MG	TABLET / ORAL	AB	2014-06-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077492-002	VALSARTAN	80MG	TABLET / ORAL	AB	2014-06-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077492-003	VALSARTAN	160MG	TABLET / ORAL	AB	2014-06-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077492-004	VALSARTAN	320MG	TABLET / ORAL	AB	2014-06-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077492-001	VALSARTAN	40MG	TABLET / ORAL	AB	2014-06-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077492-002	VALSARTAN	80MG	TABLET / ORAL	AB	2014-06-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077492-003	VALSARTAN	160MG	TABLET / ORAL	AB	2014-06-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077492-004	VALSARTAN	320MG	TABLET / ORAL	AB	2014-06-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077492-001	VALSARTAN	40MG	TABLET / ORAL	AB	2014-06-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077492-002	VALSARTAN	80MG	TABLET / ORAL	AB	2014-06-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077492-003	VALSARTAN	160MG	TABLET / ORAL	AB	2014-06-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077492-004	VALSARTAN	320MG	TABLET / ORAL	AB	2014-06-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077492-001	VALSARTAN	40MG	TABLET / ORAL	AB	2014-06-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077492-002	VALSARTAN	80MG	TABLET / ORAL	AB	2014-06-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077492-003	VALSARTAN	160MG	TABLET / ORAL	AB	2014-06-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077492-004	VALSARTAN	320MG	TABLET / ORAL	AB	2014-06-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077492-001	VALSARTAN	40MG	TABLET / ORAL	AB	2014-06-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077492-002	VALSARTAN	80MG	TABLET / ORAL	AB	2014-06-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077492-003	VALSARTAN	160MG	TABLET / ORAL	AB	2014-06-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077492-004	VALSARTAN	320MG	TABLET / ORAL	AB	2014-06-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077492-001	VALSARTAN	40MG	TABLET / ORAL	AB	2014-06-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077492-002	VALSARTAN	80MG	TABLET / ORAL	AB	2014-06-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077492-003	VALSARTAN	160MG	TABLET / ORAL	AB	2014-06-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077492-004	VALSARTAN	320MG	TABLET / ORAL	AB	2014-06-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077492-001	VALSARTAN	40MG	TABLET / ORAL	AB	2014-06-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077492-002	VALSARTAN	80MG	TABLET / ORAL	AB	2014-06-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077492-003	VALSARTAN	160MG	TABLET / ORAL	AB	2014-06-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077492-004	VALSARTAN	320MG	TABLET / ORAL	AB	2014-06-26	`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	A077492-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077492-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077492-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077492-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077492-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077492-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077492-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077492-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077492-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077492-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077492-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077492-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077492-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077492-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077492-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077492-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077492-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077492-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077492-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077492-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077492-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077492-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077492-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077492-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077492-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077492-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077492-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077492-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077492-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077492-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077492-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077492-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077492-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077492-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077492-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077492-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077492-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077492-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077492-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077492-004	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
VALSARTAN	VALSARTAN	Ohm Laboratories Inc.	ab5e0e5a-5bdf-4cfc-9d18-57ea4d642f65	2024-01-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077492 application number: ANDA077492 ndc (product): 51660-143 ndc (product): 51660-142 ndc (product): 51660-141 ndc (product): 51660-140

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
43353-203	VALSARTAN	VALSARTAN	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
51655-652	VALSARTAN	VALSARTAN	Northwind Pharmaceuticals, LLC	ANDA	Current
51655-751	Valsartan	Valsartan	Northwind Pharmaceuticals	ANDA	Current
51660-140	VALSARTAN	VALSARTAN	Ohm Laboratories Inc.	ANDA	Current
51660-140	VALSARTAN	VALSARTAN	Ohm Laboratories Inc.	ANDA	Current
51660-140	VALSARTAN	VALSARTAN	Ohm Laboratories Inc.	ANDA	Current
51660-140	VALSARTAN	VALSARTAN	Ohm Laboratories Inc.	ANDA	Current
51660-140	VALSARTAN	VALSARTAN	Ohm Laboratories Inc.	ANDA	Current
51660-141	VALSARTAN	VALSARTAN	Ohm Laboratories Inc.	ANDA	Current
51660-141	VALSARTAN	VALSARTAN	Ohm Laboratories Inc.	ANDA	Current
51660-141	VALSARTAN	VALSARTAN	Ohm Laboratories Inc.	ANDA	Current
51660-141	VALSARTAN	VALSARTAN	Ohm Laboratories Inc.	ANDA	Current
51660-141	VALSARTAN	VALSARTAN	Ohm Laboratories Inc.	ANDA	Current
51660-142	VALSARTAN	VALSARTAN	Ohm Laboratories Inc.	ANDA	Current
51660-142	VALSARTAN	VALSARTAN	Ohm Laboratories Inc.	ANDA	Current
51660-142	VALSARTAN	VALSARTAN	Ohm Laboratories Inc.	ANDA	Current
51660-142	VALSARTAN	VALSARTAN	Ohm Laboratories Inc.	ANDA	Current
51660-142	VALSARTAN	VALSARTAN	Ohm Laboratories Inc.	ANDA	Current
51660-143	VALSARTAN	VALSARTAN	Ohm Laboratories Inc.	ANDA	Current
51660-143	VALSARTAN	VALSARTAN	Ohm Laboratories Inc.	ANDA	Current
51660-143	VALSARTAN	VALSARTAN	Ohm Laboratories Inc.	ANDA	Current
51660-143	VALSARTAN	VALSARTAN	Ohm Laboratories Inc.	ANDA	Current
51660-143	VALSARTAN	VALSARTAN	Ohm Laboratories Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
18465	ORIG	2014-07-31
31249	ORIG	2014-06-27
9053	ORIG	2012-09-21