Application 207662

Type: ANDA
Sponsor: ACCORD HLTHCARE

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
A207662-001	OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-04-24
A207662-002	OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-04-24
A207662-003	OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-04-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207662-001	AB
A207662-002	AB
A207662-003	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 4 · 123 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	A207662-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-04-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207662-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-04-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207662-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-04-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207662-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-04-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207662-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-04-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207662-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-04-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207662-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-04-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207662-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-04-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207662-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-04-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207662-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-04-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207662-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-04-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207662-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-04-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207662-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-04-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207662-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-04-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207662-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-04-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207662-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-04-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207662-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-04-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207662-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-04-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207662-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-04-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207662-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-04-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207662-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-04-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207662-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-04-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207662-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-04-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207662-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-04-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207662-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-04-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207662-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-04-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207662-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-04-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207662-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-04-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207662-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-04-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207662-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-04-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207662-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-04-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207662-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-04-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207662-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-04-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207662-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-04-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207662-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-04-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207662-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-04-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207662-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-04-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207662-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-04-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207662-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-04-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207662-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-04-24	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A207662-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207662-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207662-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207662-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207662-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207662-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207662-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207662-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207662-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207662-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207662-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207662-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207662-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207662-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207662-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207662-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207662-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207662-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207662-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207662-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207662-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207662-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207662-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207662-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207662-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207662-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207662-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207662-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207662-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207662-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207662-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207662-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207662-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207662-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207662-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207662-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207662-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207662-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207662-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207662-001	AB	1	`8072bd15b7f6…`

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 · 9 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	79e2620d-6554-4e03-8087-59ec2e4dd75b	2026-04-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207662 application number: ANDA207662 ndc (product): 63629-9426
olmesartan medoxomil	OLMESARTAN MEDOXOMIL	Accord Healthcare Inc.	e5dbca00-4e1b-4479-b829-021b11bc021e	2025-10-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207662 application number: ANDA207662 ndc (product): 16729-322 ndc (product): 16729-320 ndc (product): 16729-321
Olmesartan Medoxomil	OLMESARTAN MEDOXOMIL	Direct_Rx	e64c3b3b-d5e7-6d46-e053-2a95a90a1b64	2025-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207662 application number: ANDA207662 ndc (product): 72189-373
OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	direct rx	b57e47a5-43e0-d1c5-e053-2a95a90a2b07	2025-01-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207662 application number: ANDA207662 ndc (product): 72189-138 ndc (product): 72189-137
olmesartan medoxomil	OLMESARTAN MEDOXOMIL	Bryant Ranch Prepack	8a021ffc-8b11-4ddf-81c4-87515971fdee	2024-08-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207662 application number: ANDA207662 ndc (product): 71335-0817
olmesartan medoxomil	OLMESARTAN MEDOXOMIL	Bryant Ranch Prepack	a4ceea38-8fff-4317-be04-8dc22222ec70	2024-08-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207662 application number: ANDA207662 ndc (product): 71335-0775
olmesartan medoxomil	OLMESARTAN MEDOXOMIL	A-S Medication Solutions	b55b6172-d986-4fd9-ba85-a8393c908949	2023-11-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207662 application number: ANDA207662 ndc (product): 50090-3471
olmesartan medoxomil	OLMESARTAN MEDOXOMIL	A-S Medication Solutions	949e6bad-fcb2-42f2-b9c8-e5620ef5ccd5	2023-08-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207662 application number: ANDA207662
olmesartan medoxomil	OLMESARTAN MEDOXOMIL	A-S Medication Solutions	7afa79de-d42e-4429-874d-449d47a59fbe	2023-05-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207662 application number: ANDA207662 ndc (product): 50090-3487

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 34 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16729-320	olmesartan medoxomil	olmesartan medoxomil	Accord Healthcare Inc.	ANDA	Current
16729-320	olmesartan medoxomil	olmesartan medoxomil	Accord Healthcare Inc.	ANDA	Current
16729-320	olmesartan medoxomil	olmesartan medoxomil	Accord Healthcare Inc.	ANDA	Current
16729-321	olmesartan medoxomil	olmesartan medoxomil	Accord Healthcare Inc.	ANDA	Current
16729-321	olmesartan medoxomil	olmesartan medoxomil	Accord Healthcare Inc.	ANDA	Current
16729-321	olmesartan medoxomil	olmesartan medoxomil	Accord Healthcare Inc.	ANDA	Current
16729-322	olmesartan medoxomil	olmesartan medoxomil	Accord Healthcare Inc.	ANDA	Current
16729-322	olmesartan medoxomil	olmesartan medoxomil	Accord Healthcare Inc.	ANDA	Current
16729-322	olmesartan medoxomil	olmesartan medoxomil	Accord Healthcare Inc.	ANDA	Current
50090-3471	olmesartan medoxomil	olmesartan medoxomil	A-S Medication Solutions	ANDA	Current
50090-3471	olmesartan medoxomil	olmesartan medoxomil	A-S Medication Solutions	ANDA	Current
50090-3471	olmesartan medoxomil	olmesartan medoxomil	A-S Medication Solutions	ANDA	Current
50090-3487	olmesartan medoxomil	olmesartan medoxomil	A-S Medication Solutions	ANDA	Current
50090-3487	olmesartan medoxomil	olmesartan medoxomil	A-S Medication Solutions	ANDA	Current
50090-3487	olmesartan medoxomil	olmesartan medoxomil	A-S Medication Solutions	ANDA	Current
63629-9426	olmesartan medoxomil	olmesartan medoxomil	Bryant Ranch Prepack	ANDA	Current
70518-2127	olmesartan medoxomil	olmesartan medoxomil	REMEDYREPACK INC.	ANDA	Current
70518-2127	olmesartan medoxomil	olmesartan medoxomil	REMEDYREPACK INC.	ANDA	Current
70518-2127	olmesartan medoxomil	olmesartan medoxomil	REMEDYREPACK INC.	ANDA	Current
70518-2127	olmesartan medoxomil	olmesartan medoxomil	REMEDYREPACK INC.	ANDA	Current
70518-2212	olmesartan medoxomil	olmesartan medoxomil	REMEDYREPACK INC.	ANDA	Current
70518-2212	olmesartan medoxomil	olmesartan medoxomil	REMEDYREPACK INC.	ANDA	Current
70518-2347	olmesartan medoxomil	olmesartan medoxomil	REMEDYREPACK INC.	ANDA	Current
70518-2347	olmesartan medoxomil	olmesartan medoxomil	REMEDYREPACK INC.	ANDA	Current
70518-2347	olmesartan medoxomil	olmesartan medoxomil	REMEDYREPACK INC.	ANDA	Current
71335-0775	olmesartan medoxomil	olmesartan medoxomil	Bryant Ranch Prepack	ANDA	Current
71335-0775	olmesartan medoxomil	olmesartan medoxomil	Bryant Ranch Prepack	ANDA	Current
71335-0775	olmesartan medoxomil	olmesartan medoxomil	Bryant Ranch Prepack	ANDA	Current
71335-0817	olmesartan medoxomil	olmesartan medoxomil	Bryant Ranch Prepack	ANDA	Current
71335-0817	olmesartan medoxomil	olmesartan medoxomil	Bryant Ranch Prepack	ANDA	Current
71335-0817	olmesartan medoxomil	olmesartan medoxomil	Bryant Ranch Prepack	ANDA	Current
72189-137	OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	direct rx	ANDA	Current
72189-138	OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	direct rx	ANDA	Current
72189-373	Olmesartan Medoxomil	Olmesartan Medoxomil	Direct_Rx	ANDA	Current