Home Applications 103411 Application 103411
Type BLA
Sponsor SIGMA TAU Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 103411 Oncaspar pegaspargase 351(a) Rx 2026-07-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ONCASPAR PEGASPARGASE VIAL 750IU/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 · 9 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0944-3810 ONCASPAR Pegaspargase Baxalta US Inc. BLA Current 0944-3810 ONCASPAR Pegaspargase Baxalta US Inc. BLA Current 72694-954 ONCASPAR Pegaspargase Servier Pharmaceuticals LLC BLA Current 72694-954 ONCASPAR Pegaspargase Servier Pharmaceuticals LLC BLA Current 72694-954 ONCASPAR Pegaspargase Servier Pharmaceuticals BLA Current 72694-954 ONCASPAR Pegaspargase Servier Pharmaceuticals LLC BLA Current 72694-954 ONCASPAR Pegaspargase Servier Pharmaceuticals LLC BLA Current 72694-954 ONCASPAR Pegaspargase Servier Pharmaceuticals LLC BLA Current 72694-954 ONCASPAR Pegaspargase Servier Pharmaceuticals LLC BLA Current