FDA.reportPublic FDA data

Application 219705

Type
ANDA
Sponsor
SANDOZ INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002AXITINIBAXITINIBTABLET1MGNoNo

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 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
INLYTAAXITINIBU.S. Pharmaceuticals8a903e31-936e-4ed7-8a59-59f32374f3382026-03-12Warnings, Adverse reactionsName fallback
generic name: AXITINIB
INLYTAAXITINIBPfizer Laboratories Div Pfizer Inc84137882-e000-47da-bd5b-fa76ab3c76f92025-02-19Warnings, Adverse reactionsName fallback
generic name: AXITINIB