olmesartan medoxomil 40 MG Oral Tablet

RxCUI
349405
RxNorm name
olmesartan medoxomil 40 MG Oral Tablet
Display name
olmesartan medoxomil 40 MG Oral Tablet
Full name
olmesartan medoxomil 40 MG Oral Tablet
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:06

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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 3 · 51 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Olmesartan medoxomilOLMESARTAN MEDOXOMILNorthStar RxLLC812d2d57-14d6-48a9-9687-85c2d125197e2026-08-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349405
Olmesartan MedoxomilOLMESARTAN MEDOXOMILDirect_Rx4a2aad53-fcba-2a61-e063-6394a90a60162026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349405
OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMILUmedica Laboratories USA Inc.c49a7f23-2af0-4607-9f21-114970f8630d2026-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349405
OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMILA-S Medication Solutions4bf142a3-ad7f-4ed5-98c2-54d8509b7dbc2026-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349405
OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMILA-S Medication Solutions7f78d14a-acf2-4f82-9d20-dfcbd5e9ffb32026-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349405
Olmesartan MedoxomilOLMESARTAN MEDOXOMILA-S Medication Solutions67aa498d-edf6-45b8-a3fd-019c3fb769602026-04-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349405
Olmesartan MedoxomilOLMESARTAN MEDOXOMILA-S Medication Solutions8acdc142-aa38-4fcb-bd15-fbba9635a4c62026-04-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349405
OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMILHEC Pharm USA Inc.4f4d89ab-58c8-27ea-e063-6394a90a87232026-03-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349405
OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMILBryant Ranch Prepack2bb63404-7d54-4482-8377-6ff02052892a2026-03-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349405
Olmesartan MedoxomilOLMESARTAN MEDOXOMILGlenmark Pharmaceuticals Inc., USA8e0adf3d-7569-4909-bab1-5fed9578ad772026-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349405
Olmesartan MedoxomilOLMESARTAN MEDOXOMILREMEDYREPACK INC.33429d86-878e-4e1e-a940-70a8a56a15ea2026-01-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349405
Olmesartan MedoxomilOLMESARTAN MEDOXOMILA-S Medication Solutionscae6cb47-0a2c-4c69-894b-89d389cab49f2026-01-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349405
Olmesartan MedoxomilOLMESARTAN MEDOXOMILA-S Medication Solutions04f0107b-4194-4412-9ebb-3219da5a9ac92026-01-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349405
Olmesartan MedoxomilOLMESARTAN MEDOXOMILChartwell RX, LLC7835d2b0-8e5d-4d3f-a95f-9252fb65025b2025-12-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349405
OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMILLifestar Pharma LLCa337a621-bf57-4aa4-8224-4356fa2cdbc42025-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349405
olmesartan medoxomilOLMESARTAN MEDOXOMILGolden State Medical Supply, Inc.865c2765-5072-d029-e053-2a91aa0a098e2025-11-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349405
olmesartan medoxomilOLMESARTAN MEDOXOMILBryant Ranch Prepack8466711a-3a02-4675-96db-c7cffdb897782025-11-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349405
olmesartan medoxomilOLMESARTAN MEDOXOMILAccord Healthcare Inc.e5dbca00-4e1b-4479-b829-021b11bc021e2025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349405
OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMILA-S Medication Solutions3c001b8d-f6c1-4316-b8c0-590b2fa7f2e52025-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349405
OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMILA-S Medication Solutions38f7f201-3a3a-4922-bde7-d34187b4c81d2025-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349405

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 2 · 50 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
8466711a-3a02-4675-96db-c7cffdb89778olmesartan medoxomil 40 MG Oral Tablet [PSN] · olmesartan medoxomil 40 MG Oral Tablet [SCD]2103These highlights do not include all the information needed to use OLMESARTAN MEDOXOMIL TABLETS safely and effectively. See full prescribing information for OLMESARTAN MEDOXOMIL TABLETS. OLMESARTAN MEDOXOMIL tablets, for oral use Initial U.S. Approval: 200220251110
0a49d951-dd1b-413b-99e5-d3119267c46colmesartan medoxomil 40 MG Oral Tablet [PSN] · olmesartan medoxomil 40 MG Oral Tablet [SCD]2102These highlights do not include all the information needed to use OLMESARTAN MEDOXOMIL TABLETS safely and effectively. See full prescribing information for OLMESARTAN MEDOXOMIL TABLETS. OLMESARTAN MEDOXOMIL tablets, for oral use Initial U.S. Approval: 200220250331
8a021ffc-8b11-4ddf-81c4-87515971fdeeolmesartan medoxomil 40 MG Oral Tablet [PSN] · olmesartan medoxomil 40 MG Oral Tablet [SCD]2102These highlights do not include all the information needed to use OLMESARTAN MEDOXOMIL TABLETS safely and effectively. See full prescribing information for OLMESARTAN MEDOXOMIL TABLETS. OLMESARTAN MEDOXOMIL tablets, for oral use Initial U.S. Approval: 200220240827
c35408d2-a4b5-43de-8dab-f74a60fa9853olmesartan medoxomil 40 MG Oral Tablet [PSN] · olmesartan medoxomil 40 MG Oral Tablet [SCD]2102These highlights do not include all the information needed to use OLMESARTAN MEDOXOMIL TABLETS safely and effectively. See full prescribing information for OLMESARTAN MEDOXOMIL TABLETS. OLMESARTAN MEDOXOMIL tablets, for oral use Initial U.S. Approval: 200220240111
2bb63404-7d54-4482-8377-6ff02052892aolmesartan medoxomil 40 MG Oral Tablet [PSN] · olmesartan medoxomil 40 MG Oral Tablet [SCD]2100These highlights do not include all the information needed to use OLMESARTAN MEDOXOMIL TABLETS safely and effectively. See full prescribing information for OLMESARTAN MEDOXOMIL TABLETS . Initial U.S. Approval: 200220260312
a337a621-bf57-4aa4-8224-4356fa2cdbc4olmesartan medoxomil 40 MG Oral Tablet [PSN] · olmesartan medoxomil 40 MG Oral Tablet [SCD]227These highlights do not include all the information needed to use OLMESARTAN MEDOXOMIL TABLETS safely and effectively. See full prescribing information for OLMESARTAN MEDOXOMIL TABLETS. OLMESARTAN MEDOXOMIL tablets, for oral use Initial U.S. Approval: 200220251209
04f0107b-4194-4412-9ebb-3219da5a9ac9olmesartan medoxomil 40 MG Oral Tablet [PSN] · olmesartan medoxomil 40 MG Oral Tablet [SCD]215These highlights do not include all the information needed to use OLMESARTAN MEDOXOMIL TABLETS safely and effectively. See full prescribing information for OLMESARTAN MEDOXOMIL TABLETS. OLMESARTAN MEDOXOMIL tablets, for oral use Initial U.S. Approval: 200220260120
cf4f62f9-5a00-4313-b703-ec0ac6380b5eolmesartan medoxomil 40 MG Oral Tablet [PSN] · olmesartan medoxomil 40 MG Oral Tablet [SCD]210These highlights do not include all the information needed to use OLMESARTAN MEDOXOMIL TABLETS safely and effectively. See full prescribing information for OLMESARTAN MEDOXOMIL TABLETS. OLMESARTAN MEDOXOMIL tablets, for oral use Initial U.S. Approval: 200220230623
e5dbca00-4e1b-4479-b829-021b11bc021eolmesartan medoxomil 40 MG Oral Tablet [PSN] · olmesartan medoxomil 40 MG Oral Tablet [SCD]29These highlights do not include all the information needed to use OLMESARTAN MEDOXOMIL TABLETS safely and effectively. See full prescribing information for OLMESARTAN MEDOXOMIL TABLETS. OLMESARTAN MEDOXOMIL tablets, for oral use Initial U.S. Approval: 200220251029
142b735a-e1cd-46e1-a523-3ef061001bf9olmesartan medoxomil 40 MG Oral Tablet [PSN] · olmesartan medoxomil 40 MG Oral Tablet [SCD]29These highlights do not include all the information needed to use OLMESARTAN MEDOXOMIL TABLETS safely and effectively. See full prescribing information for OLMESARTAN MEDOXOMIL TABLETS. OLMESARTAN MEDOXOMIL tablets, for oral use Initial U.S. Approval: 200220250811
8c94d403-809b-43b9-834f-3ecd330d2dd9olmesartan medoxomil 40 MG Oral Tablet [PSN] · olmesartan medoxomil 40 MG Oral Tablet [SCD]29These highlights do not include all the information needed to use OLMESARTAN MEDOXOMIL TABLETS safely and effectively. See full prescribing information for OLMESARTAN MEDOXOMIL TABLETS. OLMESARTAN MEDOXOMIL tablets, for oral use Initial U.S. Approval: 200220250104
7afa79de-d42e-4429-874d-449d47a59fbeolmesartan medoxomil 40 MG Oral Tablet [PSN] · olmesartan medoxomil 40 MG Oral Tablet [SCD]29These highlights do not include all the information needed to use OLMESARTAN MEDOXOMIL TABLETS safely and effectively. See full prescribing information for OLMESARTAN MEDOXOMIL TABLETS. OLMESARTAN MEDOXOMIL tablets, for oral use Initial U.S. Approval: 200220230525
8e0adf3d-7569-4909-bab1-5fed9578ad77olmesartan medoxomil 40 MG Oral Tablet [PSN] · olmesartan medoxomil 40 MG Oral Tablet [SCD]28These highlights do not include all the information needed to use OLMESARTAN MEDOXOMIL TABLETS safely and effectively. See full prescribing information for OLMESARTAN MEDOXOMIL TABLETS. OLMESARTAN MEDOXOMIL tablets, for oral use Initial U.S. Approval: 200220260130
c620361a-dc2d-28a1-e053-2995a90abd14olmesartan medoxomil 40 MG Oral Tablet [PSN] · olmesartan medoxomil 40 MG Oral Tablet [SCD]28These highlights do not include all the information needed to use OLMESARTAN MEDOXOMIL TABLETS safely and effectively. See full prescribing information for OLMESARTAN MEDOXOMIL TABLETS. OLMESARTAN MEDOXOMIL tablets, for oral use Initial U.S. Approval: 200220241029
ac08ea7d-f529-42ca-850a-a0ecce7dc830olmesartan medoxomil 40 MG Oral Tablet [PSN] · olmesartan medoxomil 40 MG Oral Tablet [SCD]28These highlights do not include all the information needed to use olmesartan medoxomil safely and effectively. See full prescribing information for olmesartan medoxomil tablets. Olmesartan Medoxomil Tablets, for Oral use. Initial U.S. Approval: 200220230118
f15664a4-6b5f-4e88-ad56-c827ed90a40colmesartan medoxomil 40 MG Oral Tablet [PSN] · olmesartan medoxomil 40 MG Oral Tablet [SCD]28These highlights do not include all the information needed to use OLMESARTAN MEDOXOMIL TABLETS safely and effectively. See full prescribing information for OLMESARTAN MEDOXOMIL TABLETS. OLMESARTAN MEDOXOMIL tablets, for oral use Initial U.S. Approval: 200220210108
67aa498d-edf6-45b8-a3fd-019c3fb76960olmesartan medoxomil 40 MG Oral Tablet [PSN] · olmesartan medoxomil 40 MG Oral Tablet [SCD]27These highlights do not include all the information needed to use OLMESARTAN MEDOXOMIL TABLETS safely and effectively. See full prescribing information for OLMESARTAN MEDOXOMIL TABLETS. OLMESARTAN MEDOXOMIL tablets, for oral use Initial U.S. Approval: 200220260416
33429d86-878e-4e1e-a940-70a8a56a15eaolmesartan medoxomil 40 MG Oral Tablet [PSN] · olmesartan medoxomil 40 MG Oral Tablet [SCD]27These highlights do not include all the information needed to use OLMESARTAN MEDOXOMIL TABLETS safely and effectively. See full prescribing information for OLMESARTAN MEDOXOMIL TABLETS. OLMESARTAN MEDOXOMIL tablets, for oral use Initial U.S. Approval: 200220260121
de799a31-50ae-4b9e-a159-3d399b523dcaolmesartan medoxomil 40 MG Oral Tablet [PSN] · olmesartan medoxomil 40 MG Oral Tablet [SCD]27These highlights do not include all the information needed to use OLMESARTAN MEDOXOMIL TABLETS safely and effectively. See full prescribing information for OLMESARTAN MEDOXOMIL TABLETS. OLMESARTAN MEDOXOMIL tablets, for oral use Initial U.S. Approval: 200220250527
18f1a4fc-dfca-4dde-8a11-f7e6d9e5656dolmesartan medoxomil 40 MG Oral Tablet [PSN] · olmesartan medoxomil 40 MG Oral Tablet [SCD]27These highlights do not include all the information needed to use BENICAR safely and effectively. See full prescribing information for BENICAR. BENICAR (olmesartan medoxomil) tablets, for oral use Initial U.S. Approval: 200220121112
d5658d8a-f8e9-454d-89a9-34884e753001olmesartan medoxomil 40 MG Oral Tablet [PSN] · olmesartan medoxomil 40 MG Oral Tablet [SCD]26These highlights do not include all the information needed to use OLMESARTAN MEDOXOMIL TABLETS safely and effectively. See full prescribing information for OLMESARTAN MEDOXOMIL TABLETS. OLMESARTAN MEDOXOMIL Tablets, for oral use Initial U.S. Approval: 200220250323
c5416a9f-1dcc-4851-bbc0-6664d22fc8faolmesartan medoxomil 40 MG Oral Tablet [PSN] · olmesartan medoxomil 40 MG Oral Tablet [SCD]26These highlights do not include all the information needed to use OLMESARTAN MEDOXOMIL TABLETS safely and effectively. See full prescribing information for OLMESARTAN MEDOXOMIL TABLETS. OLMESARTAN MEDOXOMIL tablets, for oral use Initial U.S. Approval: 200220240805
6e602f81-1cc3-4ae1-8bdf-85572e35cf73olmesartan medoxomil 40 MG Oral Tablet [PSN] · olmesartan medoxomil 40 MG Oral Tablet [SCD]26These highlights do not include all the information needed to use OLMESARTAN MEDOXOMIL TABLETS safely and effectively. See full prescribing information for OLMESARTAN MEDOXOMIL TABLETS . Initial U.S. Approval: 200220220304
865c2765-5072-d029-e053-2a91aa0a098eolmesartan medoxomil 40 MG Oral Tablet [PSN] · olmesartan medoxomil 40 MG Oral Tablet [SCD]25OLMESARTAN MEDOXOMIL TABLETS. These highlights do not include all the information needed to use OLMESARTAN MEDOXOMIL TABLETS safely and effectively. See full prescribing information for OLMESARTAN MEDOXOMIL TABLETS. OLMESARTAN MEDOXOMIL tablets, for oral use Initial U.S. Approval: 200220251125
1be698df-30a0-4117-8c24-7253af94c8adolmesartan medoxomil 40 MG Oral Tablet [PSN] · olmesartan medoxomil 40 MG Oral Tablet [SCD]24These highlights do not include all the information needed to use OLMESARTAN MEDOXOMIL TABLETS safely and effectively. See full prescribing information for OLMESARTAN MEDOXOMIL TABLETS. OLMESARTAN MEDOXOMIL tablets, for oral use Initial U.S. Approval: 200220250925
b57e47a5-43e0-d1c5-e053-2a95a90a2b07olmesartan medoxomil 40 MG Oral Tablet [PSN] · olmesartan medoxomil 40 MG Oral Tablet [SCD]24OLMESARTAN MEDOXOMIL20250117
8acdc142-aa38-4fcb-bd15-fbba9635a4c6olmesartan medoxomil 40 MG Oral Tablet [PSN] · olmesartan medoxomil 40 MG Oral Tablet [SCD]23These highlights do not include all the information needed to use OLMESARTAN MEDOXOMIL TABLETS safely and effectively. See full prescribing information for OLMESARTAN MEDOXOMIL TABLETS. OLMESARTAN MEDOXOMIL tablets, for oral use Initial U.S. Approval: 200220260416
cae6cb47-0a2c-4c69-894b-89d389cab49folmesartan medoxomil 40 MG Oral Tablet [PSN] · olmesartan medoxomil 40 MG Oral Tablet [SCD]23These highlights do not include all the information needed to use OLMESARTAN MEDOXOMIL TABLETS safely and effectively. See full prescribing information for OLMESARTAN MEDOXOMIL TABLETS. OLMESARTAN MEDOXOMIL tablets, for oral use Initial U.S. Approval: 200220260120
b02ff20e-3f0e-43f4-a7b5-6ce56295d023olmesartan medoxomil 40 MG Oral Tablet [PSN] · olmesartan medoxomil 40 MG Oral Tablet [SCD]23These highlights do not include all the information needed to use OLMESARTAN MEDOXOMIL TABLETS safely and effectively. See full prescribing information for OLMESARTAN MEDOXOMIL TABLETS. OLMESARTAN MEDOXOMIL tablets, for oral use Initial U.S. Approval: 200220241016
05a807bf-5175-43a2-a676-215bba2645a8olmesartan medoxomil 40 MG Oral Tablet [PSN] · olmesartan medoxomil 40 MG Oral Tablet [SCD]23These highlights do not include all the information needed to use OLMESARTAN MEDOXOMIL TABLETS safely and effectively. See full prescribing information for OLMESARTAN MEDOXOMIL TABLETS. OLMESARTAN MEDOXOMIL tablets, for oral use Initial U.S. Approval: 200220230915
5b6f8a18-8f8a-4521-81c3-3a39c73c6646olmesartan medoxomil 40 MG Oral Tablet [PSN] · olmesartan medoxomil 40 MG Oral Tablet [SCD]23These highlights do not include all the information needed to use BENICAR safely and effectively. See full prescribing information for BENICAR. BENICAR (olmesartan medoxomil) tablets, for oral use Initial U.S. Approval: 200220230712
7835d2b0-8e5d-4d3f-a95f-9252fb65025bolmesartan medoxomil 40 MG Oral Tablet [PSN] · olmesartan medoxomil 40 MG Oral Tablet [SCD]22OLMESARTAN MEDOXOMIL tablets These highlights do not include all the information needed to use OLMESARTAN MEDOXOMIL TABLETS safely and effectively. See full prescribing information for OLMESARTAN MEDOXOMIL TABLETS. OLMESARTAN MEDOXOMIL tablets, for oral use Initial U.S. Approval: 200220251222
38f7f201-3a3a-4922-bde7-d34187b4c81dolmesartan medoxomil 40 MG Oral Tablet [PSN] · olmesartan medoxomil 40 MG Oral Tablet [SCD]22These highlights do not include all the information needed to use OLMESARTAN MEDOXOMIL TABLETS safely and effectively. See full prescribing information for OLMESARTAN MEDOXOMIL TABLETS. OLMESARTAN MEDOXOMIL tablets, for oral use Initial U.S. Approval: 200220251009
eff8b514-bb7f-427e-a267-7dee25fff611olmesartan medoxomil 40 MG Oral Tablet [PSN] · olmesartan medoxomil 40 MG Oral Tablet [SCD]22These highlights do not include all the information needed to use OLMESARTAN MEDOXOMIL TABLETS safely and effectively. See full prescribing information for OLMESARTAN MEDOXOMIL TABLETS. OLMESARTAN MEDOXOMIL tablets, for oral use Initial U.S. Approval: 200220241101
16754802-d5a4-0350-e063-6394a90aa967olmesartan medoxomil 40 MG Oral Tablet [PSN] · olmesartan medoxomil 40 MG Oral Tablet [SCD]22Olmesartan Medoxomil20240926
98f930d5-f7c2-4870-92b4-0ad37ce45797olmesartan medoxomil 40 MG Oral Tablet [PSN] · olmesartan medoxomil 40 MG Oral Tablet [SCD]22These highlights do not include all the information needed to use OLMESARTAN MEDOXOMIL TABLETS safely and effectively. See full prescribing information for OLMESARTAN MEDOXOMIL TABLETS. OLMESARTAN MEDOXOMIL tablets, for oral use Initial U.S. Approval: 200220240514
4238a064-1bfd-4ce3-b9d9-12c96eee8af0olmesartan medoxomil 40 MG Oral Tablet [PSN] · olmesartan medoxomil 40 MG Oral Tablet [SCD]22These highlights do not include all the information needed to use OLMESARTAN MEDOXOMIL TABLETS safely and effectively. See full prescribing information for OLMESARTAN MEDOXOMIL TABLETS. OLMESARTAN MEDOXOMIL tablets, for oral use Initial U.S. Approval: 200220231130
5f410909-a68a-4ada-963a-32018d37572folmesartan medoxomil 40 MG Oral Tablet [PSN] · olmesartan medoxomil 40 MG Oral Tablet [SCD]22These highlights do not include all the information needed to use OLMESARTAN MEDOXOMIL TABLETS safely and effectively. See full prescribing information for OLMESARTAN MEDOXOMIL TABLETS. OLMESARTAN MEDOXOMIL tablets, for oral use Initial U.S. Approval: 200220230911
e210f962-9b91-46c6-af8f-9f9a9ae84245olmesartan medoxomil 40 MG Oral Tablet [PSN] · olmesartan medoxomil 40 MG Oral Tablet [SCD]22These highlights do not include all the information needed to use OLMESARTAN MEDOXOMIL TABLETS safely and effectively. See full prescribing information for OLMESARTAN MEDOXOMIL TABLETS. OLMESARTAN MEDOXOMIL tablets, for oral use Initial U.S. Approval: 200220191001
1f430fc9-bd4c-4328-a4a2-501ec991029bolmesartan medoxomil 40 MG Oral Tablet [PSN] · olmesartan medoxomil 40 MG Oral Tablet [SCD]21These highlights do not include all the information needed to use OLMESARTAN MEDOXOMIL TABLETS safely and effectively. See full prescribing information for OLMESARTAN MEDOXOMIL TABLETS. OLMESARTAN MEDOXOMIL tablets, for oral use Initial U.S. Approval: 200220250227