Application 078276

Type: ANDA
Sponsor: MYLAN

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 43.

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	Approval date
A078276-001	OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	2016-10-26
A078276-002	OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	2016-10-26
A078276-003	OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	2016-10-26

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 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A078276-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	2016-10-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078276-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	2016-10-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078276-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	2016-10-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078276-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	2016-10-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078276-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	2016-10-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078276-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	2016-10-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078276-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	2016-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078276-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	2016-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078276-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	2016-10-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078276-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	2016-10-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078276-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	2016-10-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078276-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	2016-10-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078276-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	2016-10-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078276-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	2016-10-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078276-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	2016-10-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078276-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	2016-10-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078276-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	2016-10-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078276-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	2016-10-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078276-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	2016-10-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078276-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	2016-10-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078276-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	2016-10-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078276-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	2016-10-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078276-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	2016-10-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078276-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	2016-10-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078276-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	2016-10-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078276-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	2016-10-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078276-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	2016-10-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078276-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	2016-10-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078276-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	2016-10-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078276-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	2016-10-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078276-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	2016-10-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078276-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	2016-10-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078276-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	2016-10-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078276-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	2016-10-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078276-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	2016-10-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078276-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	2016-10-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078276-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	2016-10-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078276-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	2016-10-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078276-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	2016-10-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078276-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	2016-10-26	`301d65b070ca…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A078276-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078276-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078276-003	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078276-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078276-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078276-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078276-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A078276-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A078276-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078276-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078276-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078276-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078276-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078276-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078276-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078276-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078276-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078276-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078276-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078276-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078276-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078276-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078276-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078276-003	AB	1	`ea99ee380514…`

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	REMEDYREPACK INC.	33429d86-878e-4e1e-a940-70a8a56a15ea	2026-01-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olmesartan Medoxomil generic name: OLMESARTAN MEDOXOMIL
Olmesartan Medoxomil	OLMESARTAN MEDOXOMIL	A-S Medication Solutions	cae6cb47-0a2c-4c69-894b-89d389cab49f	2026-01-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olmesartan Medoxomil generic name: OLMESARTAN MEDOXOMIL
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
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	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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-7012	Olmesartan Medoxomil	olmesartan medoxomil	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-7012	Olmesartan Medoxomil	olmesartan medoxomil	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-7112	Olmesartan Medoxomil	olmesartan medoxomil	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-7112	Olmesartan Medoxomil	olmesartan medoxomil	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-7124	Olmesartan Medoxomil	olmesartan medoxomil	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-7124	Olmesartan Medoxomil	olmesartan medoxomil	Mylan Pharmaceuticals Inc.	ANDA	Current
42292-036	Olmesartan Medoxomil	olmesartan medoxomil	Mylan Institutional Inc.	ANDA	Current
42292-037	Olmesartan Medoxomil	olmesartan medoxomil	Mylan Institutional Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
45728	ORIG	2016-10-31