← FDA Drug Approvals (Drugs@FDA)

AUKELSO

BLA · Biologics License Application · Sponsor: BIOCON BIOLOGICS INC · Approved 2025-09-16

Drug application

FDA Application #

BLA761436

Application type

Biologics License Application

Brand name

AUKELSO

Generic name

DENOSUMAB-KYQQ

Active ingredients

DENOSUMAB-KYQQ

Dosage form

INJECTABLE

Route

INJECTION

Marketing status

Prescription

Sponsor

BIOCON BIOLOGICS INC

Manufacturer

Biocon Biologics Inc.

First approval

2025-09-16

Source

Authoritative

Drugs@FDA application overview

Machine

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