Home Applications 761278 Application 761278
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 761278 Lamzede velmanase alfa-tycv 351(a) Rx 2026-08-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LAMZEDE VELMANASE ALFA-TYCV POWDER, FOR INJECTION SOLUTION, LYOPHILIZED POWDER 10MG 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 Lamzede VELMANASE ALFA-TYCV Chiesi USA, Inc. 36d50a08-60bd-40eb-807c-778d69bf2d2e 2023-02-21 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA761278
Documents# Document, Submission type, Date table Document Submission type Date 73781 ORIG 2023-03-17 73549 ORIG 2023-02-17 73548 ORIG 2023-02-17