Rituximab
Product Approval Information - Licensing Action
Proper name: Rituximab
Tradename: Rituxan
Manufacturer: Genentech, Inc, South San Francisco, CA, License #1048
Indication for Use: Treatment of patients with relapsed or refractory low-grade or follicular, B-cell non-Hodgkin's lymphoma
Approval Date: 11/26/97
Type of submission: Biologics license application
Approval Letter -
PDF,
Text
Label - PDF
Reviews (PDF)
Clinical (41 pages) [error correction in Comparison chart on page number 20 posted 9/9/98]
Product (9 pages)
Talk Paper
Last Updated: 3/6/2001
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Updated: September 25, 2003 |