← FDA Drug Approvals (Drugs@FDA)

ENHERTU

BLA · Biologics License Application · Sponsor: DAIICHI SANKYO · Approved 2019-12-20

Drug application

FDA Application #

BLA761139

Application type

Biologics License Application

Brand name

ENHERTU

Generic name

FAM-TRASTUZUMAB DERUXTECAN-NXKI

Active ingredients

FAM-TRASTUZUMAB DERUXTECAN-NXKI

Dosage form

INJECTABLE

Route

INJECTION

Marketing status

Prescription

Sponsor

DAIICHI SANKYO

Manufacturer

Daiichi Sankyo Inc.

First approval

2019-12-20

Source

Authoritative

Drugs@FDA application overview

Machine

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