Application 091079

Type: ANDA
Sponsor: TEVA PHARMS USA

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
A091079-001	OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	2017-04-24
A091079-002	OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	2017-04-24
A091079-003	OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	2017-04-24

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	A091079-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	2017-04-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091079-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	2017-04-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091079-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	2017-04-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091079-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	2017-04-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091079-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	2017-04-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091079-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	2017-04-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091079-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	2017-04-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091079-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	2017-04-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091079-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	2017-04-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091079-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	2017-04-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091079-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	2017-04-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091079-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	2017-04-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091079-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	2017-04-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091079-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	2017-04-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091079-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	2017-04-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091079-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	2017-04-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091079-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	2017-04-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091079-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	2017-04-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091079-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	2017-04-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091079-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	2017-04-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091079-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	2017-04-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091079-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	2017-04-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091079-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	2017-04-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091079-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	2017-04-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091079-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	2017-04-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091079-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	2017-04-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091079-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	2017-04-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091079-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	2017-04-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091079-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	2017-04-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091079-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	2017-04-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091079-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	2017-04-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091079-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	2017-04-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091079-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	2017-04-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091079-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	2017-04-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091079-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	2017-04-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091079-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	2017-04-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091079-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	2017-04-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091079-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	2017-04-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091079-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	2017-04-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091079-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	2017-04-24	`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	A091079-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091079-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091079-003	AB	1	`74a2ff9319b5…`
2019-09-15 20:21 UTC	2019-09	A091079-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A091079-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A091079-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091079-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A091079-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A091079-003	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 4 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	Inventia Healthcare Limited	05a807bf-5175-43a2-a676-215bba2645a8	2023-09-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: OLMESARTAN MEDOXOMIL generic name: OLMESARTAN MEDOXOMIL
Olmesartan medoxomil	OLMESARTAN MEDOXOMIL	A-S Medication Solutions	9d9f1c08-4f65-484c-943e-7e664281910f	2023-09-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olmesartan medoxomil generic name: OLMESARTAN MEDOXOMIL
Olmesartan medoxomil	OLMESARTAN MEDOXOMIL	A-S Medication Solutions	5f410909-a68a-4ada-963a-32018d37572f	2023-09-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olmesartan medoxomil generic name: OLMESARTAN MEDOXOMIL
olmesartan medoxomil	OLMESARTAN MEDOXOMIL	A-S Medication Solutions	949e6bad-fcb2-42f2-b9c8-e5620ef5ccd5	2023-08-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: olmesartan medoxomil generic name: OLMESARTAN MEDOXOMIL
Benicar	OLMESARTAN MEDOXOMIL	Cosette Pharmaceuticals, Inc.	5b6f8a18-8f8a-4521-81c3-3a39c73c6646	2023-07-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: OLMESARTAN MEDOXOMIL
Olmesartan Medoxomil	OLMESARTAN MEDOXOMIL	Alembic Pharmaceuticals Inc.	cf4f62f9-5a00-4313-b703-ec0ac6380b5e	2023-06-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olmesartan Medoxomil generic name: OLMESARTAN MEDOXOMIL
olmesartan medoxomil	OLMESARTAN MEDOXOMIL	Bryant Ranch Prepack	409e06ad-2ea9-4b47-829e-57139e22eac9	2023-06-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: olmesartan medoxomil generic name: OLMESARTAN MEDOXOMIL
olmesartan medoxomil	OLMESARTAN MEDOXOMIL	A-S Medication Solutions	7afa79de-d42e-4429-874d-449d47a59fbe	2023-05-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: olmesartan medoxomil generic name: OLMESARTAN MEDOXOMIL
Olmesartan Medoxomil	OLMESARTAN MEDOXOMIL	Alembic Pharmaceuticals Limited	ac08ea7d-f529-42ca-850a-a0ecce7dc830	2023-01-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olmesartan Medoxomil generic name: OLMESARTAN MEDOXOMIL
OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	Solco Healthcare US, LLC.	6e602f81-1cc3-4ae1-8bdf-85572e35cf73	2022-03-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: OLMESARTAN MEDOXOMIL generic name: OLMESARTAN MEDOXOMIL
olmesartan medoxomil	OLMESARTAN MEDOXOMIL	ScieGen Pharmaceuticals, Inc.	f15664a4-6b5f-4e88-ad56-c827ed90a40c	2021-01-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: olmesartan medoxomil generic name: OLMESARTAN MEDOXOMIL
Olmesartan Medoxomil	OLMESARTAN MEDOXOMIL	Proficient Rx LP	e210f962-9b91-46c6-af8f-9f9a9ae84245	2019-10-01	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 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-7611	Olmesartan Medoxomil	Olmesartan Medoxomil	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7612	Olmesartan Medoxomil	Olmesartan Medoxomil	Teva Pharmaceuticals USA, Inc.	ANDA	Current
50090-3105	Olmesartan Medoxomil	Olmesartan Medoxomil	A-S Medication Solutions	ANDA	Current
50090-3107	Olmesartan Medoxomil	Olmesartan Medoxomil	A-S Medication Solutions	ANDA	Current
63629-7267	Olmesartan Medoxomil	Olmesartan Medoxomil	Bryant Ranch Prepack	ANDA	Current
71335-0018	Olmesartan Medoxomil	Olmesartan Medoxomil	Bryant Ranch Prepack	ANDA	Current