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 2026-07-01
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# 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 · 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