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Exdensur

depemokimab-ulaa

351(a) Standalone BLA

Overview

Source: Purple Book
Proprietary name
Exdensur
Proper name
depemokimab-ulaa
Licence type
351(a)
BLA number
761458
Applicant
GlaxoSmithKline LLC
Center
CDER
Presentations
2
First licensure
—

Presentations

Source: Purple Book
Every strength and presentation recorded in the Purple Book for this product.
Strength Dosage form Route Presentation Status Licensed
100MG/ML Injection Subcutaneous Autoinjector Disc December 16, 2025
100MG/ML Injection Subcutaneous Pre-Filled Syringe Rx December 16, 2025

Sources for this page

Purple Book FDA Licence type, presentations, reference product, exclusivity