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Ocrevus Zunovo

ocrelizumab and hyaluronidase-ocsq

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Ocrevus Zunovo

Proper name

ocrelizumab and hyaluronidase-ocsq

Licence type

351(a)

BLA number

761371

Applicant

Genentech, Inc.

Center

CDER

Presentations

First licensure

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Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
920MG/23ML; 23,000UNITS/23ML (40MG/1,000UNITS/ML)	Injection	Subcutaneous	Single-Dose Vial	Rx	September 13, 2024

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