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SIMPONI

BLA · Biologics License Application · Sponsor: CENTOCOR ORTHO BIOTECH INC · Approved 2009-04-24

Drug application

FDA Application #

BLA125289

Application type

Biologics License Application

Brand name

SIMPONI

Generic name

GOLIMUMAB

Active ingredients

GOLIMUMAB

Dosage form

INJECTABLE

Route

INJECTION

Marketing status

Prescription

Sponsor

CENTOCOR ORTHO BIOTECH INC

Manufacturer

Janssen Biotech, Inc.

First approval

2009-04-24

Source

Authoritative

Drugs@FDA application overview

Machine

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