Application 218792

Type
ANDA
Sponsor
SANDOZ INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002UPADACITINIBUPADACITINIBTABLET, EXTENDED RELEASE30MGNoNo
003UPADACITINIBUPADACITINIBTABLET, EXTENDED RELEASE15MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

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 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