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PROLIA

BLA · Biologics License Application · Sponsor: AMGEN · Approved 2010-06-01

Drug application

FDA Application #

BLA125320

Application type

Biologics License Application

Brand name

PROLIA

Generic name

DENOSUMAB

Active ingredients

DENOSUMAB

Dosage form

INJECTABLE

Route

SUBCUTANEOUS

Marketing status

Prescription

Sponsor

AMGEN

Manufacturer

Amgen, Inc

First approval

2010-06-01

Source

Authoritative

Drugs@FDA application overview

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