Home Applications 761211 Application 761211
Type BLA
Sponsor IMMEDICA PHARMA AB Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761211 Loargys pegzilarginase-nbln 351(a) Rx 2026-06-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LOARGYS PEGZILARGINASE-NBLN Injectable; Injection 0.1MG/KG 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 ยท 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Loargys PEGZILARGINASE-NBLN Immedica Pharma US Inc. d5ceabf2-43a0-4746-9371-d98a39cf6cfc 2026-02-23 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA761211
Documents# Document, Submission type, Date table Document Submission type Date 85642 ORIG 2026-04-07 85393 ORIG 2026-03-18 85152 ORIG 2026-02-24