← FDA Drug Approvals (Drugs@FDA)

RENFLEXIS

BLA · Biologics License Application · Sponsor: SAMSUNG BIOEPIS CO LTD · Approved 2017-04-21

Drug application

FDA Application #

BLA761054

Application type

Biologics License Application

Brand name

RENFLEXIS

Generic name

INFLIXIMAB

Active ingredients

INFLIXIMAB-ABDA

Dosage form

INJECTABLE

Route

INJECTION

Marketing status

Prescription

Sponsor

SAMSUNG BIOEPIS CO LTD

Manufacturer

Organon LLC

First approval

2017-04-21

Source

Authoritative

Drugs@FDA application overview

Machine

JSON-LD · Markdown