FDA.reportPublic FDA data

Application 215464

Type
ANDA
Sponsor
SANDOZ INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IBRUTINIBIBRUTINIBTABLET;ORAL140MGNoNo
002IBRUTINIBIBRUTINIBTABLET;ORAL280MGNoNo
003IBRUTINIBIBRUTINIBTABLET;ORAL420MGNoNo
004IBRUTINIBIBRUTINIBTABLET;ORAL560MGNoNo

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
ImbruvicaIBRUTINIBPharmacyclics LLC0dfd0279-ff17-4ea9-89be-9803c71bab442025-10-21Warnings, Adverse reactionsName fallback
generic name: IBRUTINIB