Home Applications 761113 Application 761113
Type BLA
Sponsor SANOFI AVENTIS US Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761113 Sarclisa isatuximab-irfc 351(a) Rx 2026-07-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 SARCLISA ISATUXIMAB-IRFC INJECTABLE;INJECTION 100MG/5ML (20MG/ML) No No 002 SARCLISA ISATUXIMAB-IRFC INJECTABLE;INJECTION 500MG/25ML (20MG/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 · 8 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0024-0654 Sarclisa isatuximab sanof-aventis U.S. LLC BLA Current 0024-0654 Sarclisa isatuximab sanof-aventis U.S. LLC BLA Current 0024-0654 Sarclisa isatuximab sanof-aventis U.S. LLC BLA Current 0024-0654 Sarclisa isatuximab sanof-aventis U.S. LLC BLA Current 0024-0656 Sarclisa isatuximab sanof-aventis U.S. LLC BLA Current 0024-0656 Sarclisa isatuximab sanof-aventis U.S. LLC BLA Current 0024-0656 Sarclisa isatuximab sanof-aventis U.S. LLC BLA Current 0024-0656 Sarclisa isatuximab sanof-aventis U.S. LLC BLA Current