Rituximab Formulated Bulk (For Further Manufacturing Use)

Proper name: Rituximab Formulated Bulk (For Further Manufacturing Use)
Tradename: None
Manufacturer: IDEC Pharmaceutical Corp, San Diego, CA, License #1235
Indication for Use: For use in the manufacture of Rituximab by Genentech, Inc, under a shared manufacturing arrangement
Approval Date: 11/26/97
Type of submission: Biologics license application

Approval Letter - PDF, Text

Reviews (PDF)
    Clinical (Rituximab) (41 pages)
    CMC 1 (4 pages)
    CMC 2 (14 pages)
    Preclinical and Clinical Pharmacology (5 pages)
    Product (6 pages)
    Statistical (9 pages)

Last Updated: 3/6/2001

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Updated: September 25, 2003

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