FDA.reportPublic FDA data

Application 212763

Type
ANDA
Sponsor
ALVOGEN PINE BROOK

Application Products#

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

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 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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
67425ORIG2021-05-06