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Vyepti

eptinezumab-jjmr

351(a) Standalone BLA

Overview

Source: Purple Book
Proprietary name
Vyepti
Proper name
eptinezumab-jjmr
Licence type
351(a)
BLA number
761119
Applicant
Lundbeck Seattle BioPharmaceuticals, Inc.
Center
CDER
Presentations
1
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 Intravenous Single-Dose Vial Rx February 21, 2020

Sources for this page

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