← FDA Drug Approvals (Drugs@FDA)

PONLIMSI

BLA · Biologics License Application · Sponsor: TEVA PHARMACEUTICALS, INC. · Approved 2026-03-27

Drug application

FDA Application #

BLA761385

Application type

Biologics License Application

Brand name

PONLIMSI

Generic name

Denosumab-Adet

Active ingredients

DENOSUMAB-ADET

Dosage form

INJECTABLE

Route

SUBCUTANEOUS

Marketing status

Prescription

Sponsor

TEVA PHARMACEUTICALS, INC.

First approval

2026-03-27

Source

Authoritative

Drugs@FDA application overview

Machine

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