FDA.reportPublic FDA data

Application 218866

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001UPADACITINIBUPADACITINIBTABLET;ORAL15MGNoNo
002UPADACITINIBUPADACITINIBTABLET;ORAL30MGNoNo

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
RinvoqUPADACITINIBAbbVie Inc.2966aec7-2ef0-923c-d8ff-fe1a957bf0952026-06-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: UPADACITINIB

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81323ORIG 2025-02-24