FDA.reportPublic FDA data

Application 219088

Type
ANDA
Sponsor
AUROBINDO PHARMA LIMITED

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001UBROGEPANTUBROGEPANTTABLET100MGNoNo
002UBROGEPANTUBROGEPANTTABLET50MGNoNo

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
UBRELVYUBROGEPANTAllergan, Inc.fd9f9458-fd96-4688-be3f-f77b3d1af6ab2025-06-05Warnings, Adverse reactionsName fallback
generic name: UBROGEPANT