← FDA Drug Approvals (Drugs@FDA)

INFLECTRA

BLA · Biologics License Application · Sponsor: CELLTRION INC · Approved 2016-04-05

Drug application

FDA Application #

BLA125544

Application type

Biologics License Application

Brand name

INFLECTRA

Generic name

INFLIXIMAB-DYYB

Active ingredients

INFLIXIMAB-DYYB

Dosage form

INJECTABLE

Route

INJECTION

Marketing status

Prescription

Sponsor

CELLTRION INC

Manufacturer

Pfizer Laboratories Div Pfizer Inc

First approval

2016-04-05

Source

Authoritative

Drugs@FDA application overview

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