Home Applications 761092 Application 761092
Type BLA
Sponsor LEADIANT BIOSCI INC Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761092 Revcovi elapegademase-lvlr 351(a) Rx 2026-08-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 REVCOVI ELAPEGADEMASE-LVLR INJECTABLE;INJECTION 1.6MG/ML 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 · 12 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 10122-502 Revcovi elapegademase-lvlr Chiesi USA, Inc. BLA Current 10122-502 Revcovi elapegademase-lvlr Chiesi USA, Inc. BLA Current 10122-502 Revcovi elapegademase-lvlr Chiesi USA, Inc. BLA Current 57665-002 Revcovi elapegademase-lvlr Leadiant Biosciences, Inc. BLA Current 57665-002 Revcovi elapegademase-lvlr Leadiant Biosciences, Inc. BLA Current 57665-002 Revcovi elapegademase-lvlr Leadiant Biosciences, Inc. BLA Current 57665-002 Revcovi elapegademase-lvlr Leadiant Biosciences, Inc. BLA Current 57665-002 Revcovi elapegademase-lvlr Leadiant Biosciences, Inc. BLA Current 57665-002 Revcovi elapegademase-lvlr Leadiant Biosciences, Inc. BLA Current 57665-002 Revcovi elapegademase-lvlr Leadiant Biosciences, Inc. BLA Current 57665-002 Revcovi elapegademase-lvlr Leadiant Biosciences, Inc. BLA Current 57665-002 Revcovi elapegademase-lvlr Leadiant Biosciences, Inc. BLA Current
Documents# Document, Submission type, Date table Document Submission type Date 65529 SUPPL 2020-12-08 65514 SUPPL 2020-12-07 56322 ORIG 2018-11-07 55936 ORIG 2018-10-15 55849 ORIG 2018-10-05