Rituximab Formulated Bulk (For Further Manufacturing Use)
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,
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 |