Home Applications 103946 Application 103946
Type BLA
Sponsor SANOFI SYNTHELABO Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 103946 Elitek rasburicase 351(a) Rx 2026-07-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ELITEK RASBURICASE VIAL; INTRAVENOUS 1.5MG/VIAL 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 · 7 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0024-5150 Elitek rasburicase sanofi-aventis U.S. LLC BLA Current 0024-5150 Elitek rasburicase Sanofi-Aventis U.S. LLC BLA Current 0024-5150 Elitek rasburicase Sanofi-Aventis U.S. LLC BLA Current 0024-5150 Elitek rasburicase Sanofi-Aventis U.S. LLC BLA Current 0024-5151 Elitek rasburicase Sanofi-Aventis U.S. LLC BLA Current 0024-5151 Elitek rasburicase Sanofi-Aventis U.S. LLC BLA Current 0024-5151 Elitek rasburicase Sanofi-Aventis U.S. LLC BLA Current