Home Applications 125390 Application 125390
Type BLA
Sponsor AEGERION Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125390 Myalept metreleptin 351(a) Rx 2026-08-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 MYALEPT METRELEPTIN INJECTABLE;INJECTION 11.3MG 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Myalept METRELEPTIN Chiesi USA, Inc. d3b50bbd-140b-425c-b5ec-d4682aad62bc 2024-03-25 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA125390
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 76431-210 Myalept metreleptin Aegerion Pharmaceuticals, Inc. BLA Current 76431-210 Myalept metreleptin Amryt Pharmaceuticals DAC BLA Current 76431-210 Myalept metreleptin Aegerion Pharmaceuticals, Inc. BLA Current 76431-210 Myalept metreleptin Aegerion Pharmaceuticals, Inc. BLA Current 76431-210 Myalept metreleptin Amryt Pharmaceuticals DAC BLA Current 76431-210 Myalept metreleptin Amryt Pharmaceuticals DAC BLA Current