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 3 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	Direct_rx	1ba299e7-0651-c23b-e063-6294a90a0245	2025-01-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olmesartan Medoxomil generic name: OLMESARTAN MEDOXOMIL
Olmesartan Medoxomil	OLMESARTAN MEDOXOMIL	Direct_Rx	e64c3b3b-d5e7-6d46-e053-2a95a90a1b64	2025-01-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olmesartan Medoxomil generic name: OLMESARTAN MEDOXOMIL
OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	direct rx	b57e47a5-43e0-d1c5-e053-2a95a90a2b07	2025-01-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: OLMESARTAN MEDOXOMIL generic name: OLMESARTAN MEDOXOMIL
Olmesartan Medoxomil	OLMESARTAN MEDOXOMIL	Aurobindo Pharma Limited	8c94d403-809b-43b9-834f-3ecd330d2dd9	2025-01-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olmesartan Medoxomil generic name: OLMESARTAN MEDOXOMIL
Olmesartan Medoxomil	OLMESARTAN MEDOXOMIL	Proficient Rx LP	eff8b514-bb7f-427e-a267-7dee25fff611	2024-11-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olmesartan Medoxomil generic name: OLMESARTAN MEDOXOMIL
OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	Lannett Company, Inc.	c620361a-dc2d-28a1-e053-2995a90abd14	2024-10-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: OLMESARTAN MEDOXOMIL generic name: OLMESARTAN MEDOXOMIL
OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	Rising Pharma Holdings, Inc.	b02ff20e-3f0e-43f4-a7b5-6ce56295d023	2024-10-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: OLMESARTAN MEDOXOMIL generic name: OLMESARTAN MEDOXOMIL
Olmesartan Medoxomil	OLMESARTAN MEDOXOMIL	Direct_Rx	16754802-d5a4-0350-e063-6394a90aa967	2024-09-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olmesartan Medoxomil generic name: OLMESARTAN MEDOXOMIL
olmesartan medoxomil	OLMESARTAN MEDOXOMIL	Bryant Ranch Prepack	8a021ffc-8b11-4ddf-81c4-87515971fdee	2024-08-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: olmesartan medoxomil generic name: OLMESARTAN MEDOXOMIL
olmesartan medoxomil	OLMESARTAN MEDOXOMIL	Bryant Ranch Prepack	a4ceea38-8fff-4317-be04-8dc22222ec70	2024-08-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: olmesartan medoxomil generic name: OLMESARTAN MEDOXOMIL
Olmesartan Medoxomil	OLMESARTAN MEDOXOMIL	Bryant Ranch Prepack	afcfc1eb-29b1-46e8-a013-5cbb1737a232	2024-08-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olmesartan Medoxomil generic name: OLMESARTAN MEDOXOMIL
Olmesartan Medoxomil	OLMESARTAN MEDOXOMIL	Cadila Pharmaceuticals Limited	c5416a9f-1dcc-4851-bbc0-6664d22fc8fa	2024-08-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olmesartan Medoxomil generic name: OLMESARTAN MEDOXOMIL
OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	Bryant Ranch Prepack	879630ff-662a-40bd-b74f-a864661dea95	2024-06-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: OLMESARTAN MEDOXOMIL generic name: OLMESARTAN MEDOXOMIL
olmesartan medoxomil	OLMESARTAN MEDOXOMIL	Bryant Ranch Prepack	25431c8c-9f6e-42e7-ab84-4b062755bfe3	2024-05-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: olmesartan medoxomil generic name: OLMESARTAN MEDOXOMIL
Olmesartan Medoxomil	OLMESARTAN MEDOXOMIL	QUALLENT PHARMACEUTICALS HEALTH LLC	98f930d5-f7c2-4870-92b4-0ad37ce45797	2024-05-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olmesartan Medoxomil generic name: OLMESARTAN MEDOXOMIL
Olmesartan Medoxomil	OLMESARTAN MEDOXOMIL	Direct_Rx	16752f60-655a-f727-e063-6394a90a96b6	2024-04-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olmesartan Medoxomil generic name: OLMESARTAN MEDOXOMIL
olmesartan medoxomil	OLMESARTAN MEDOXOMIL	Bryant Ranch Prepack	fe80fd21-fa8d-474e-ac0a-23f0e1eb7f3b	2024-01-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: olmesartan medoxomil generic name: OLMESARTAN MEDOXOMIL
olmesartan medoxomil	OLMESARTAN MEDOXOMIL	Bryant Ranch Prepack	c35408d2-a4b5-43de-8dab-f74a60fa9853	2024-01-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: olmesartan medoxomil generic name: OLMESARTAN MEDOXOMIL
Olmesartan medoxomil	OLMESARTAN MEDOXOMIL	Novadoz Pharmaceuticals LLC	4238a064-1bfd-4ce3-b9d9-12c96eee8af0	2023-11-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olmesartan medoxomil generic name: OLMESARTAN MEDOXOMIL
olmesartan medoxomil	OLMESARTAN MEDOXOMIL	A-S Medication Solutions	b55b6172-d986-4fd9-ba85-a8393c908949	2023-11-07	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