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Exdensur
depemokimab-ulaa
351(a) Standalone BLA
Overview
Source: Purple BookProprietary 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| 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 |