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Evenity

romosozumab-aqqg

351(a) Standalone BLA

Overview

Source: Purple Book
Proprietary name
Evenity
Proper name
romosozumab-aqqg
Licence type
351(a)
BLA number
761062
Applicant
Amgen 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
105MG/1.17ML Injection Subcutaneous Pre-Filled Syringe Rx April 9, 2019

Sources for this page

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