FDA.reportPublic FDA data

Application 219062

Type
ANDA
Sponsor
HETERO LABS LIMITED

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AZILSARTAN MEDOXOMILAZILSARTAN MEDOXOMILTABLET80MGNoNo
002AZILSARTAN MEDOXOMILAZILSARTAN MEDOXOMILTABLET40MGNoNo
003AZILSARTAN MEDOXOMILAZILSARTAN MEDOXOMILTABLET20MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

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 ยท 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Azilsartan medoxomilAZILSARTAN MEDOXOMILLupin Pharmaceuticals, Inc.b1c8de43-3b26-408f-8c7e-6c7d763481992026-05-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Azilsartan medoxomil
generic name: AZILSARTAN MEDOXOMIL
Azilsartan MedoxomilAZILSARTAN KAMEDOXOMILWilshire Pharmaceuticals, Inc.c09103d8-c094-473d-a303-bbb4f334aa8c2026-04-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Azilsartan Medoxomil