Application 220747

Type
ANDA
Sponsor
MACLEODS PHARMACEUTICALS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002FINERENONEFINERENONETABLET; FILM COATED20MGNoNo

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 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KerendiaFINERENONEBayer HealthCare Pharmaceuticals Inc.fc726765-5d5a-4d6e-b037-b847bda9fb7c2025-08-28Warnings, Adverse reactionsName fallback
generic name: FINERENONE