FDA.reportPublic FDA data

Application 220258

Type
NDA
Sponsor
AZURITY

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RESNIBENCABOZANTINIBTABLET; ORAL13MGNoNo
002RESNIBENCABOZANTINIBTABLET; ORAL26MGNoNo
003RESNIBENCABOZANTINIBTABLET; ORAL39MGNoNo

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
CABOMETYXCABOZANTINIBExelixis, Inc.3850cce2-6137-42e5-a792-d318c4a4b3b52025-10-19Warnings, Adverse reactionsName fallback
generic name: CABOZANTINIB
COMETRIQCABOZANTINIBExelixis, Inc.1a0c3bea-c87b-4d25-bb44-5f0174da6b342025-10-18Warnings, Adverse reactionsName fallback
generic name: CABOZANTINIB

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83950ORIG 2025-10-28