← FDA Drug Approvals (Drugs@FDA)

BILPREVDA

BLA · Biologics License Application · Sponsor: SHANGHAI HENLIUS BIOTECH · Approved 2025-08-29

Drug application

FDA Application #

BLA761444

Application type

Biologics License Application

Brand name

BILPREVDA

Generic name

DENOSUMAB

Active ingredients

DENOSUMAB-NXXP

Dosage form

INJECTABLE

Route

INJECTION

Marketing status

Prescription

Sponsor

SHANGHAI HENLIUS BIOTECH

Manufacturer

Organon LLC

First approval

2025-08-29

Source

Authoritative

Drugs@FDA application overview

Machine

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