Application 210552

Type: ANDA
Sponsor: QILU

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
A210552-001	OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2019-01-10
A210552-002	OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2019-01-10
A210552-003	OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2019-01-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210552-001	AB
A210552-002	AB
A210552-003	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	A210552-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2019-01-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210552-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2019-01-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210552-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2019-01-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210552-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2019-01-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210552-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2019-01-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210552-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2019-01-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210552-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2019-01-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210552-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2019-01-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210552-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2019-01-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210552-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2019-01-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210552-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2019-01-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210552-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2019-01-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210552-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2019-01-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210552-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2019-01-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210552-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2019-01-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210552-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2019-01-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210552-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2019-01-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210552-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2019-01-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210552-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2019-01-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210552-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2019-01-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210552-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2019-01-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210552-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2019-01-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210552-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2019-01-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210552-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2019-01-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210552-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2019-01-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210552-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2019-01-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210552-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2019-01-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210552-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2019-01-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210552-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2019-01-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210552-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2019-01-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210552-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2019-01-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210552-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2019-01-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210552-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2019-01-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210552-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2019-01-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210552-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2019-01-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210552-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2019-01-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210552-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2019-01-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210552-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2019-01-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210552-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2019-01-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210552-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2019-01-10	`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	A210552-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210552-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210552-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210552-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210552-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210552-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210552-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210552-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210552-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210552-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210552-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210552-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210552-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210552-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210552-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210552-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210552-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210552-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210552-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210552-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210552-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210552-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210552-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210552-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210552-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210552-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210552-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210552-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210552-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210552-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210552-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210552-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210552-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210552-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210552-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210552-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210552-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210552-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210552-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210552-001	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 2 of 4 · 72 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Olmesartan Medoxomil	OLMESARTAN MEDOXOMIL	A-S Medication Solutions	04f0107b-4194-4412-9ebb-3219da5a9ac9	2026-01-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olmesartan Medoxomil generic name: OLMESARTAN MEDOXOMIL
Olmesartan Medoxomil	OLMESARTAN MEDOXOMIL	Chartwell RX, LLC	7835d2b0-8e5d-4d3f-a95f-9252fb65025b	2025-12-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olmesartan Medoxomil generic name: OLMESARTAN MEDOXOMIL
OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	Lifestar Pharma LLC	a337a621-bf57-4aa4-8224-4356fa2cdbc4	2025-12-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: OLMESARTAN MEDOXOMIL generic name: OLMESARTAN MEDOXOMIL
olmesartan medoxomil	OLMESARTAN MEDOXOMIL	Golden State Medical Supply, Inc.	865c2765-5072-d029-e053-2a91aa0a098e	2025-11-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: olmesartan medoxomil generic name: OLMESARTAN MEDOXOMIL
olmesartan medoxomil	OLMESARTAN MEDOXOMIL	Bryant Ranch Prepack	8466711a-3a02-4675-96db-c7cffdb89778	2025-11-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: olmesartan medoxomil generic name: OLMESARTAN MEDOXOMIL
olmesartan medoxomil	OLMESARTAN MEDOXOMIL	Accord Healthcare Inc.	e5dbca00-4e1b-4479-b829-021b11bc021e	2025-10-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: olmesartan medoxomil generic name: OLMESARTAN MEDOXOMIL
Olmesartan Medoxomil	OLMESARTAN MEDOXOMIL	Bryant Ranch Prepack	eff499eb-a0e4-4240-870c-83bb53434cc2	2025-10-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olmesartan Medoxomil generic name: OLMESARTAN MEDOXOMIL
olmesartan medoxomil	OLMESARTAN MEDOXOMIL	Bryant Ranch Prepack	640936ee-55a6-47ae-a1ad-cffae316b925	2025-10-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: olmesartan medoxomil generic name: OLMESARTAN MEDOXOMIL
OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	A-S Medication Solutions	3c001b8d-f6c1-4316-b8c0-590b2fa7f2e5	2025-10-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: OLMESARTAN MEDOXOMIL generic name: OLMESARTAN MEDOXOMIL
OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	A-S Medication Solutions	38f7f201-3a3a-4922-bde7-d34187b4c81d	2025-10-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: OLMESARTAN MEDOXOMIL generic name: OLMESARTAN MEDOXOMIL
Olmesartan Medoxomil	OLMESARTAN MEDOXOMIL	Bryant Ranch Prepack	e43e5643-b258-469d-812a-887f913cfe71	2025-10-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olmesartan Medoxomil generic name: OLMESARTAN MEDOXOMIL
olmesartan medoxomil	OLMESARTAN MEDOXOMIL	REMEDYREPACK INC.	1be698df-30a0-4117-8c24-7253af94c8ad	2025-09-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: olmesartan medoxomil generic name: OLMESARTAN MEDOXOMIL
Benicar	OLMESARTAN MEDOXOMIL	Cosette Pharmaceuticals, Inc.	dc3f1fd4-5578-4c5d-be7b-12e3f8f3e7df	2025-09-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: OLMESARTAN MEDOXOMIL
Olmesartan medoxomil	OLMESARTAN MEDOXOMIL	Macleods Pharmaceuticals Limited	24e308cc-7cec-4054-9627-66f743ed71b0	2025-09-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olmesartan medoxomil generic name: OLMESARTAN MEDOXOMIL
Olmesartan Medoxomil	OLMESARTAN MEDOXOMIL	Ascend Laboratories, LLC	142b735a-e1cd-46e1-a523-3ef061001bf9	2025-08-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olmesartan Medoxomil generic name: OLMESARTAN MEDOXOMIL
OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	Micro Labs Limited	de799a31-50ae-4b9e-a159-3d399b523dca	2025-05-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: OLMESARTAN MEDOXOMIL generic name: OLMESARTAN MEDOXOMIL
OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	Camber Pharmaceuticals, Inc.	53b8d406-a4f3-46ee-9aec-d70f7d806876	2025-05-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: OLMESARTAN MEDOXOMIL generic name: OLMESARTAN MEDOXOMIL
Olmesartan Medoxomil	OLMESARTAN MEDOXOMIL	Bryant Ranch Prepack	0a49d951-dd1b-413b-99e5-d3119267c46c	2025-03-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olmesartan Medoxomil generic name: OLMESARTAN MEDOXOMIL
olmesartan medoxomil	OLMESARTAN MEDOXOMIL	Jubilant Cadista Pharmacuticals Inc.	d5658d8a-f8e9-454d-89a9-34884e753001	2025-03-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: olmesartan medoxomil generic name: OLMESARTAN MEDOXOMIL
Olmesartan Medoxomil	OLMESARTAN MEDOXOMIL	Modavar Pharmaceuticals LLC	1f430fc9-bd4c-4328-a4a2-501ec991029b	2025-02-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olmesartan Medoxomil generic name: OLMESARTAN MEDOXOMIL