Application 761391

Type
BLA
Sponsor
GALDERMA LABS LP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NEMLUVIONEMOLIZUMAB-ILTOINJECTABLE;INJECTION30mgNoNo

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NEMLUVIONEMOLIZUMAB-ILTOGalderma Laboratories, L.P.e9229ef1-ac60-4c24-afb6-009d3c7816872025-06-26Warnings, Adverse reactionsName fallback
brand name: NEMLUVIO
generic name: NEMOLIZUMAB-ILTO

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83904ORIG 2025-10-23
82685SUPPL 2025-06-27
80593ORIG 2025-06-27
80573ORIG 2024-12-13