Home Applications 761123 Application 761123
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 761123 Saphnelo anifrolumab-fnia 351(a) Rx 2026-06-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 SAPHNELO ANIFROLUMAB-FNIA INJECTABLE;INJECTION 300MG/2ML(150MG/ML) No No
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 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 4 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0310-3040 SAPHNELO Anifrolumab AstraZeneca Pharmaceuticals LP BLA Current 0310-3040 SAPHNELO Anifrolumab AstraZeneca Pharmaceuticals LP BLA Current 0310-3040 SAPHNELO Anifrolumab AstraZeneca Pharmaceuticals LP BLA Current 0310-3040 SAPHNELO Anifrolumab AstraZeneca Pharmaceuticals LP BLA Current
Documents# Document, Submission type, Date table Document Submission type Date 79353 SUPPL 2024-08-09 79339 SUPPL 2024-08-08 76728 SUPPL 2023-12-05 76722 SUPPL 2023-12-04 68390 ORIG 2021-08-17 68261 ORIG 2021-08-02 68232 ORIG 2021-08-02