Application 208659

Type: ANDA
Sponsor: INVENTIA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	TABLET;ORAL	5MG	No	No
002	OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	TABLET;ORAL	20MG	No	No
003	OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	TABLET;ORAL	40MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A208659-001	OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2020-05-18
A208659-002	OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2020-05-18
A208659-003	OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2020-05-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A208659-001	AB
A208659-002	AB
A208659-003	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 3 · 111 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	A208659-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2020-05-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208659-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2020-05-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208659-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2020-05-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208659-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2020-05-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208659-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2020-05-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208659-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2020-05-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208659-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2020-05-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208659-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2020-05-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208659-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2020-05-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208659-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2020-05-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208659-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2020-05-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208659-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2020-05-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208659-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2020-05-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208659-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2020-05-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208659-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2020-05-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208659-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2020-05-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208659-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2020-05-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208659-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2020-05-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208659-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2020-05-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208659-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2020-05-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208659-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2020-05-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208659-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2020-05-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208659-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2020-05-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208659-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2020-05-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208659-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2020-05-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208659-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2020-05-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208659-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2020-05-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208659-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2020-05-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208659-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2020-05-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208659-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2020-05-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208659-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2020-05-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208659-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2020-05-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208659-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2020-05-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208659-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2020-05-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208659-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2020-05-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208659-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2020-05-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208659-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2020-05-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208659-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2020-05-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208659-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2020-05-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208659-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL		2020-05-18	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 45 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	A208659-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208659-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208659-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208659-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208659-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208659-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208659-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208659-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208659-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208659-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208659-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208659-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208659-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208659-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208659-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208659-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208659-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208659-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208659-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208659-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208659-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208659-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208659-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208659-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208659-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208659-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208659-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208659-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208659-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208659-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208659-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208659-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208659-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208659-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208659-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208659-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208659-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208659-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208659-003	AB	1	`1e350fbaab3a…`
2020-11-12 02:37 UTC	2020-11	A208659-001	AB	1	`c0c555d07b60…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	Bryant Ranch Prepack	1df1ff60-6be5-4018-a28c-0d23e5867eba	2026-07-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208659 application number: ANDA208659
OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	Rising Pharma Holdings, Inc.	b02ff20e-3f0e-43f4-a7b5-6ce56295d023	2024-10-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208659 application number: ANDA208659
OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	Inventia Healthcare Limited	05a807bf-5175-43a2-a676-215bba2645a8	2023-09-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208659 application number: ANDA208659 ndc (product): 49252-067 ndc (product): 49252-065 ndc (product): 49252-066

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
49252-065	OLMESARTAN MEDOXOMIL	olmesartan medoxomil	Inventia Healthcare Limited	ANDA	Current
49252-065	OLMESARTAN MEDOXOMIL	olmesartan medoxomil	Inventia Healthcare Limited	ANDA	Current
49252-066	OLMESARTAN MEDOXOMIL	olmesartan medoxomil	Inventia Healthcare Limited	ANDA	Current
49252-066	OLMESARTAN MEDOXOMIL	olmesartan medoxomil	Inventia Healthcare Limited	ANDA	Current
49252-067	OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	Inventia Healthcare Limited	ANDA	Current
49252-067	OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	Inventia Healthcare Limited	ANDA	Current