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Rituxan Hycela

rituximab and hyaluronidase human

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Rituxan Hycela

Proper name

rituximab and hyaluronidase human

Licence type

351(a)

BLA number

761064

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
1,400MG/11.7ML; 23,400UNITS/11.7ML (120MG/2,000UNITS/ML)	Injection	Subcutaneous	Single-Dose Vial	Rx	June 22, 2017
1,600MG/13.4ML; 26,800UNITS/13.4ML (120MG/2,000UNITS/ML)	Injection	Subcutaneous	Single-Dose Vial	Rx	June 22, 2017

Source: Purple Book

Kind	Expires
Orphan exclusivity	June 22, 2024

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