← FDA Drug Approvals (Drugs@FDA)

DENOSUMAB-DSSB

BLA · Biologics License Application · Sponsor: SAMSUNG BIOEPIS CO LTD · Approved 2025-10-29

Drug application

FDA Application #

BLA761392

Application type

Biologics License Application

Brand name

DENOSUMAB-DSSB

Generic name

DENOSUMAB

Active ingredients

DENOSUMAB-DSSB

Dosage form

INJECTABLE

Route

SUBCUTANEOUS

Marketing status

Prescription

Sponsor

SAMSUNG BIOEPIS CO LTD

Manufacturer

Cordavis Limited

First approval

2025-10-29

Source

Authoritative

Drugs@FDA application overview

Machine

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