← FDA Drug Approvals (Drugs@FDA)

ZYMFENTRA

BLA · Biologics License Application · Sponsor: CELLTRION · Approved 2023-10-20

Drug application

FDA Application #

BLA761358

Application type

Biologics License Application

Brand name

ZYMFENTRA

Generic name

INFLIXIMAB-DYYB

Active ingredients

INFLIXIMAB-DYYB

Dosage form

INJECTABLE

Route

INJECTION

Marketing status

Prescription

Sponsor

CELLTRION

Manufacturer

CELLTRION USA Inc.

First approval

2023-10-20

Source

Authoritative

Drugs@FDA application overview

Machine

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