Home Applications 761161 Application 761161
Type BLA
Sponsor CHIESI FARMACEUTICI SPA Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761161 Elfabrio pegunigalsidase alfa-iwxj 351(a) Rx 2026-08-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ELFABRIO PEGUNIGALSIDASE ALFA-IWXJ VIAL; SINGLE-USE 20MG/10ML 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 ยท 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ELFABRIO PEGUNIGALSIDASE ALFA Chiesi USA, Inc. 6fb674bf-744e-431f-92ef-b2a5a66c8cf3 2024-07-08 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA761161
Documents# Document, Submission type, Date table Document Submission type Date 74470 ORIG 2023-06-09 74210 ORIG 2023-05-10 74205 ORIG 2023-05-10