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 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	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 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078276-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	2016-10-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078276-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	2016-10-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078276-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	2016-10-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078276-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	2016-10-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078276-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	2016-10-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078276-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	2016-10-26	`8072bd15b7f6…`

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 1 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	Bryant Ranch Prepack	1df1ff60-6be5-4018-a28c-0d23e5867eba	2026-07-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: OLMESARTAN MEDOXOMIL generic name: OLMESARTAN MEDOXOMIL
Olmesartan Medoxomil	OLMESARTAN MEDOXOMIL	Direct_Rx	4a2aad53-fcba-2a61-e063-6394a90a6016	2026-06-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olmesartan Medoxomil generic name: OLMESARTAN MEDOXOMIL
olmesartan medoxomil	OLMESARTAN MEDOXOMIL	REMEDYREPACK INC.	fe6e39da-fb6e-46da-9c03-c765020a7c87	2026-06-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: olmesartan medoxomil generic name: OLMESARTAN MEDOXOMIL
OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	Umedica Laboratories USA Inc.	c49a7f23-2af0-4607-9f21-114970f8630d	2026-06-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: OLMESARTAN MEDOXOMIL generic name: OLMESARTAN MEDOXOMIL
OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	A-S Medication Solutions	4bf142a3-ad7f-4ed5-98c2-54d8509b7dbc	2026-05-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: OLMESARTAN MEDOXOMIL generic name: OLMESARTAN MEDOXOMIL
OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	A-S Medication Solutions	7f78d14a-acf2-4f82-9d20-dfcbd5e9ffb3	2026-05-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: OLMESARTAN MEDOXOMIL generic name: OLMESARTAN MEDOXOMIL
Olmesartan Medoxomil	OLMESARTAN MEDOXOMIL	A-S Medication Solutions	5972c6fd-08e3-4189-a894-1ba220b57e80	2026-05-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olmesartan Medoxomil generic name: OLMESARTAN MEDOXOMIL
Olmesartan Medoxomil	OLMESARTAN MEDOXOMIL	Bryant Ranch Prepack	57dc737b-01e2-4b22-991f-d4710950dcf3	2026-05-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olmesartan Medoxomil generic name: OLMESARTAN MEDOXOMIL
olmesartan medoxomil	OLMESARTAN MEDOXOMIL	Bryant Ranch Prepack	79e2620d-6554-4e03-8087-59ec2e4dd75b	2026-04-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: olmesartan medoxomil generic name: OLMESARTAN MEDOXOMIL
Olmesartan Medoxomil	OLMESARTAN MEDOXOMIL	REMEDYREPACK INC.	92969ed0-8dcd-4c6d-b0c4-e8469c2f65a9	2026-04-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olmesartan Medoxomil generic name: OLMESARTAN MEDOXOMIL
Olmesartan Medoxomil	OLMESARTAN MEDOXOMIL	A-S Medication Solutions	67aa498d-edf6-45b8-a3fd-019c3fb76960	2026-04-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olmesartan Medoxomil generic name: OLMESARTAN MEDOXOMIL
Olmesartan Medoxomil	OLMESARTAN MEDOXOMIL	A-S Medication Solutions	8acdc142-aa38-4fcb-bd15-fbba9635a4c6	2026-04-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olmesartan Medoxomil generic name: OLMESARTAN MEDOXOMIL
Olmesartan medoxomil	OLMESARTAN MEDOXOMIL	REMEDYREPACK INC.	85a24657-583b-4776-98c9-b30285cb3058	2026-03-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olmesartan medoxomil generic name: OLMESARTAN MEDOXOMIL
OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	HEC Pharm USA Inc.	4f4d89ab-58c8-27ea-e063-6394a90a8723	2026-03-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: OLMESARTAN MEDOXOMIL generic name: OLMESARTAN MEDOXOMIL
OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	Bryant Ranch Prepack	2bb63404-7d54-4482-8377-6ff02052892a	2026-03-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: OLMESARTAN MEDOXOMIL generic name: OLMESARTAN MEDOXOMIL
Olmesartan Medoxomil	OLMESARTAN MEDOXOMIL	A-S Medication Solutions	eeb16efc-4413-4464-9eb8-effa1e5684aa	2026-02-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olmesartan Medoxomil generic name: OLMESARTAN MEDOXOMIL
Olmesartan Medoxomil	OLMESARTAN MEDOXOMIL	A-S Medication Solutions	26065167-37c9-4e95-aa2c-3005b6805a52	2026-02-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olmesartan Medoxomil generic name: OLMESARTAN MEDOXOMIL
Olmesartan Medoxomil	OLMESARTAN MEDOXOMIL	Glenmark Pharmaceuticals Inc., USA	8e0adf3d-7569-4909-bab1-5fed9578ad77	2026-01-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olmesartan Medoxomil generic name: OLMESARTAN MEDOXOMIL
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

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