FDA.reportPublic FDA data

Application 210234

Type
ANDA
Sponsor
TEVA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AXITINIBAXITINIBTABLET;ORAL1MGNoNo
002AXITINIBAXITINIBTABLET;ORAL5MGNoNo

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 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

Reported adverse events (FAERS/openFDA)#

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