Application 761270

Type
BLA
Sponsor
ASTRAZENECA AB

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IMJUDOTREMELIMUMAB-ACTLINJECTABLE;INTRAVENOUS, SUBCUTANEOUS25MG/1.25ML(20MG/ML)NoNo
002IMJUDOTREMELIMUMAB-ACTLINJECTABLE;INTRAVENOUS, SUBCUTANEOUS300MG/15ML(20MG/ML)NoNo

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
IMJUDOTREMELIMUMABAstraZeneca Pharmaceuticals LP6690679c-be2f-4588-a2e4-89fff74dd6be2024-07-24Warnings, Adverse reactionsName fallback
brand name: IMJUDO

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
74263ORIG 2023-05-16
72610ORIG2022-11-14
72603ORIG2022-11-13
72602ORIG2022-11-13