Application 215942

Type
ANDA
Sponsor
TEVA PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CABOZANTINIBCABOZANTINIBTABLET;ORAL20MGNoNo
002CABOZANTINIBCABOZANTINIBTABLET;ORAL40MGNoNo
003CABOZANTINIBCABOZANTINIBTABLET;ORAL60MGNoNo

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