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Rituxan

rituximab

351(a) Standalone BLA

Overview

Source: Purple Book
Proprietary name
Rituxan
Proper name
rituximab
Licence type
351(a)
BLA number
103705
Applicant
Genentech, Inc.
Center
CDER
Presentations
4
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/10ML (10MG/ML) Injection Intravenous Single-Dose Vial Rx November 26, 1997
100MG/10ML (10MG/ML) Injection Intravenous Single-Dose Vial Disc February 19, 2002
500MG/50ML (10MG/ML) Injection Intravenous Single-Dose Vial Rx November 26, 1997
500MG/50ML (10MG/ML) Injection Intravenous Single-Dose Vial Disc February 19, 2002

Exclusivity

Source: Purple Book
Kind Expires
Orphan exclusivityDecember 2, 2028

Sources for this page

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