Home Applications 761451 Application 761451
Type BLA
Sponsor ASTRAZENECA AB Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761451 Saphnelo anifrolumab-fnia 351(a) Rx 2026-07-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 SAPHNELO ANIFROLIMAB-FNIA VIAL; SINGLE-USE 300MG/2ML (150MG/ML No No 002 SAPHNELO ANIFROLIMAB-FNIA INJECTION 120MG/0.8ML 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 SAPHNELO ANIFROLUMAB-FNIA AstraZeneca Pharmaceuticals LP d6203302-2128-41a7-b0b4-0e6c0704d4dc 2026-04-24 Warnings, Adverse reactions Exact identifier application number: BLA761451
Documents# Document, Submission type, Date table Document Submission type Date 85774 ORIG 2026-04-28 85772 ORIG 2026-04-27