← FDA Drug Approvals (Drugs@FDA)

ENOBY

BLA · Biologics License Application · Sponsor: HIKMA PHARMACEUTICALS USA INC · Approved 2025-09-26

Drug application

FDA Application #

BLA761439

Application type

Biologics License Application

Brand name

ENOBY

Generic name

DENOSUMAB-QBDE

Active ingredients

DENOSUMAB-QBDE

Dosage form

SOLUTION

Route

INJECTION

Marketing status

Prescription

Sponsor

HIKMA PHARMACEUTICALS USA INC

Manufacturer

Hikma Pharmaceuticals USA Inc.

First approval

2025-09-26

Source

Authoritative

Drugs@FDA application overview

Machine

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