Home Applications 761390 Application 761390
Type BLA
Sponsor GALDERMA LABS LP Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761390 Nemluvio nemolizumab-ilto 351(a) Rx 2026-06-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 NEMLUVIO NEMOLIZUMAB-ILTO INJECTABLE;INJECTION 30MG 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 NEMLUVIO NEMOLIZUMAB-ILTO Galderma Laboratories, L.P. e9229ef1-ac60-4c24-afb6-009d3c781687 2025-06-26 Warnings, Adverse reactions Exact identifier application number: BLA761390
Documents# Document, Submission type, Date table Document Submission type Date 82762 SUPPL 2025-07-10 82679 SUPPL 2025-06-27 81999 SUPPL 2025-04-25 81990 SUPPL 2025-04-25 79570 ORIG 2024-09-10 79386 ORIG 2024-08-13 79382 ORIG 2024-08-13