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Ocrevus

ocrelizumab

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Ocrevus

Proper name

ocrelizumab

Licence type

351(a)

BLA number

761053

Applicant

Genentech, Inc.

Center

CDER

Presentations

1

First licensure

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Presentations

Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
300MG/10ML (30MG/ML)	Injection	Intravenous	Single-Dose Vial	Rx	March 28, 2017

Sources for this page

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