Skip to content

On this page

Remicade

infliximab

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Remicade

Proper name

infliximab

Licence type

351(a)

BLA number

103772

Applicant

Janssen Biotech, Inc.

Center

CDER

Presentations

1

First licensure

—

Presentations

Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
100MG	For Injection	Intravenous	Single-Dose Vial	Rx	August 24, 1998

Exclusivity

Source: Purple Book

Kind	Expires
Orphan exclusivity	September 23, 2018

Sources for this page

Purple Book	FDA	Licence type, presentations, reference product, exclusivity