FDA.reportPublic FDA data

Application 206227

Type
ANDA
Sponsor
CHARTWELL RX

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMILTABLET;ORAL5MGNoNo
002OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMILTABLET;ORAL20MGNoNo
003OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMILTABLET;ORAL40MGNoNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A206227-001OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2024-01-25
A206227-002OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2024-01-25
A206227-003OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2024-01-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A206227-001AB
A206227-002AB
A206227-003AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A206227-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2024-01-25a50c72e98297…
2026-08-01 22:54:322026-06A206227-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2024-01-25a50c72e98297…
2026-08-01 22:54:322026-06A206227-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2024-01-25a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A206227-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A206227-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A206227-003AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 4 · 72 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMILBryant Ranch Prepack1df1ff60-6be5-4018-a28c-0d23e5867eba2026-07-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: OLMESARTAN MEDOXOMIL
generic name: OLMESARTAN MEDOXOMIL
Olmesartan MedoxomilOLMESARTAN MEDOXOMILDirect_Rx4a2aad53-fcba-2a61-e063-6394a90a60162026-06-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olmesartan Medoxomil
generic name: OLMESARTAN MEDOXOMIL
olmesartan medoxomilOLMESARTAN MEDOXOMILREMEDYREPACK INC.fe6e39da-fb6e-46da-9c03-c765020a7c872026-06-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: olmesartan medoxomil
generic name: OLMESARTAN MEDOXOMIL
OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMILUmedica Laboratories USA Inc.c49a7f23-2af0-4607-9f21-114970f8630d2026-06-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: OLMESARTAN MEDOXOMIL
generic name: OLMESARTAN MEDOXOMIL
OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMILA-S Medication Solutions4bf142a3-ad7f-4ed5-98c2-54d8509b7dbc2026-05-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: OLMESARTAN MEDOXOMIL
generic name: OLMESARTAN MEDOXOMIL
OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMILA-S Medication Solutions7f78d14a-acf2-4f82-9d20-dfcbd5e9ffb32026-05-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: OLMESARTAN MEDOXOMIL
generic name: OLMESARTAN MEDOXOMIL
Olmesartan MedoxomilOLMESARTAN MEDOXOMILA-S Medication Solutions5972c6fd-08e3-4189-a894-1ba220b57e802026-05-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olmesartan Medoxomil
generic name: OLMESARTAN MEDOXOMIL
Olmesartan MedoxomilOLMESARTAN MEDOXOMILBryant Ranch Prepack57dc737b-01e2-4b22-991f-d4710950dcf32026-05-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olmesartan Medoxomil
generic name: OLMESARTAN MEDOXOMIL
olmesartan medoxomilOLMESARTAN MEDOXOMILBryant Ranch Prepack79e2620d-6554-4e03-8087-59ec2e4dd75b2026-04-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: olmesartan medoxomil
generic name: OLMESARTAN MEDOXOMIL
Olmesartan MedoxomilOLMESARTAN MEDOXOMILREMEDYREPACK INC.92969ed0-8dcd-4c6d-b0c4-e8469c2f65a92026-04-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olmesartan Medoxomil
generic name: OLMESARTAN MEDOXOMIL
Olmesartan MedoxomilOLMESARTAN MEDOXOMILA-S Medication Solutions67aa498d-edf6-45b8-a3fd-019c3fb769602026-04-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olmesartan Medoxomil
generic name: OLMESARTAN MEDOXOMIL
Olmesartan MedoxomilOLMESARTAN MEDOXOMILA-S Medication Solutions8acdc142-aa38-4fcb-bd15-fbba9635a4c62026-04-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olmesartan Medoxomil
generic name: OLMESARTAN MEDOXOMIL
Olmesartan medoxomilOLMESARTAN MEDOXOMILREMEDYREPACK INC.85a24657-583b-4776-98c9-b30285cb30582026-03-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olmesartan medoxomil
generic name: OLMESARTAN MEDOXOMIL
OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMILHEC Pharm USA Inc.4f4d89ab-58c8-27ea-e063-6394a90a87232026-03-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: OLMESARTAN MEDOXOMIL
generic name: OLMESARTAN MEDOXOMIL
OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMILBryant Ranch Prepack2bb63404-7d54-4482-8377-6ff02052892a2026-03-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: OLMESARTAN MEDOXOMIL
generic name: OLMESARTAN MEDOXOMIL
Olmesartan MedoxomilOLMESARTAN MEDOXOMILA-S Medication Solutionseeb16efc-4413-4464-9eb8-effa1e5684aa2026-02-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olmesartan Medoxomil
generic name: OLMESARTAN MEDOXOMIL
Olmesartan MedoxomilOLMESARTAN MEDOXOMILA-S Medication Solutions26065167-37c9-4e95-aa2c-3005b6805a522026-02-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olmesartan Medoxomil
generic name: OLMESARTAN MEDOXOMIL
Olmesartan MedoxomilOLMESARTAN MEDOXOMILGlenmark Pharmaceuticals Inc., USA8e0adf3d-7569-4909-bab1-5fed9578ad772026-01-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olmesartan Medoxomil
generic name: OLMESARTAN MEDOXOMIL
Olmesartan MedoxomilOLMESARTAN MEDOXOMILREMEDYREPACK INC.33429d86-878e-4e1e-a940-70a8a56a15ea2026-01-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olmesartan Medoxomil
generic name: OLMESARTAN MEDOXOMIL
Olmesartan MedoxomilOLMESARTAN MEDOXOMILA-S Medication Solutionscae6cb47-0a2c-4c69-894b-89d389cab49f2026-01-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olmesartan Medoxomil
generic name: OLMESARTAN MEDOXOMIL