Home Applications 761430 Application 761430
Type BLA
Sponsor JANSSEN BIOTECH Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761430 Imaavy nipocalimab-aahu 351(a) Rx 2026-06-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 IMAAVY NIPOCALIMAB-AAHU INJECTABLE;INJECTION 300MG/1.62ML(185MG/ML) No No 002 IMAAVY NIPOCALIMAB-AAHU INJECTABLE;INJECTION 1200MG/6.5ML(185MG/ML) No No
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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join IMAAVY NIPOCALIMAB-AAHU Janssen Biotech, Inc. 8886274c-f2b2-48af-85c1-2f90bfe304b8 2025-05-07 Warnings, Adverse reactions Exact identifier application number: BLA761430
Documents# Document, Submission type, Date table Document Submission type Date 82433 ORIG 2025-06-02 82140 ORIG 2025-05-05 82076 ORIG 2025-04-30