Application 211049

Type: ANDA
Sponsor: SUNSHINE LAKE

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
A211049-001	OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2019-02-22
A211049-002	OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2019-02-22
A211049-003	OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2019-02-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211049-001	AB
A211049-002	AB
A211049-003	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	A211049-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2019-02-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211049-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2019-02-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211049-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2019-02-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211049-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2019-02-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211049-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2019-02-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211049-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2019-02-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211049-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2019-02-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211049-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2019-02-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211049-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2019-02-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211049-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2019-02-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211049-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2019-02-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211049-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2019-02-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211049-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2019-02-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211049-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2019-02-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211049-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2019-02-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211049-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2019-02-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211049-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2019-02-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211049-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2019-02-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211049-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2019-02-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211049-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2019-02-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211049-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2019-02-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211049-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2019-02-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211049-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2019-02-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211049-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2019-02-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211049-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2019-02-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211049-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2019-02-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211049-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2019-02-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211049-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2019-02-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211049-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2019-02-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211049-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2019-02-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211049-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2019-02-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211049-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2019-02-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211049-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2019-02-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211049-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2019-02-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211049-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2019-02-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211049-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2019-02-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211049-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2019-02-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211049-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2019-02-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211049-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2019-02-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211049-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2019-02-22	`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	A211049-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211049-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211049-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211049-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211049-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211049-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211049-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211049-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211049-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211049-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211049-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211049-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211049-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211049-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211049-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211049-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211049-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211049-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211049-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211049-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211049-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211049-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211049-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211049-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211049-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211049-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211049-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211049-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211049-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211049-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211049-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211049-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211049-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211049-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211049-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211049-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211049-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211049-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211049-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211049-001	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 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	HEC Pharm USA Inc.	4f4d89ab-58c8-27ea-e063-6394a90a8723	2026-03-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211049 application number: ANDA211049
Olmesartan Medoxomil	OLMESARTAN MEDOXOMIL	Chartwell RX, LLC	7835d2b0-8e5d-4d3f-a95f-9252fb65025b	2025-12-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211049 application number: ANDA211049
OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	A-S Medication Solutions	3c001b8d-f6c1-4316-b8c0-590b2fa7f2e5	2025-10-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211049 application number: ANDA211049
OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	A-S Medication Solutions	38f7f201-3a3a-4922-bde7-d34187b4c81d	2025-10-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211049 application number: ANDA211049
OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	Lannett Company, Inc.	c620361a-dc2d-28a1-e053-2995a90abd14	2024-10-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211049 application number: ANDA211049 ndc (product): 0527-2426 ndc (product): 0527-2427 ndc (product): 0527-2425

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0527-2425	OLMESARTAN MEDOXOMIL	Olmesartan medoxomil	Lannett Company, Inc.	ANDA	Current
0527-2425	OLMESARTAN MEDOXOMIL	Olmesartan medoxomil	Lannett Company, Inc.	ANDA	Current
0527-2425	OLMESARTAN MEDOXOMIL	Olmesartan medoxomil	Lannett Company, Inc.	ANDA	Current
0527-2425	OLMESARTAN MEDOXOMIL	Olmesartan medoxomil	Lannett Company, Inc.	ANDA	Current
0527-2425	OLMESARTAN MEDOXOMIL	Olmesartan medoxomil	Lannett Company, Inc.	ANDA	Current
0527-2426	OLMESARTAN MEDOXOMIL	Olmesartan medoxomil	Lannett Company, Inc.	ANDA	Current
0527-2426	OLMESARTAN MEDOXOMIL	Olmesartan medoxomil	Lannett Company, Inc.	ANDA	Current
0527-2426	OLMESARTAN MEDOXOMIL	Olmesartan medoxomil	Lannett Company, Inc.	ANDA	Current
0527-2426	OLMESARTAN MEDOXOMIL	Olmesartan medoxomil	Lannett Company, Inc.	ANDA	Current
0527-2426	OLMESARTAN MEDOXOMIL	Olmesartan medoxomil	Lannett Company, Inc.	ANDA	Current
0527-2427	OLMESARTAN MEDOXOMIL	Olmesartan medoxomil	Lannett Company, Inc.	ANDA	Current
0527-2427	OLMESARTAN MEDOXOMIL	Olmesartan medoxomil	Lannett Company, Inc.	ANDA	Current
0527-2427	OLMESARTAN MEDOXOMIL	Olmesartan medoxomil	Lannett Company, Inc.	ANDA	Current
0527-2427	OLMESARTAN MEDOXOMIL	Olmesartan medoxomil	Lannett Company, Inc.	ANDA	Current
0527-2427	OLMESARTAN MEDOXOMIL	Olmesartan medoxomil	Lannett Company, Inc.	ANDA	Current
48792-7877	OLMESARTAN MEDOXOMIL	Olmesartan medoxomil	Sunshine Lake Pharma Co., Ltd.	ANDA	Current
48792-7878	OLMESARTAN MEDOXOMIL	Olmesartan medoxomil	Sunshine Lake Pharma Co., Ltd.	ANDA	Current
48792-7879	OLMESARTAN MEDOXOMIL	Olmesartan medoxomil	Sunshine Lake Pharma Co., Ltd.	ANDA	Current