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U.S. Department of Health and Human Services

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Rituximab Formulated Bulk Product Approval Information - Licensing Action

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

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)