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Daclizumab
Product Approval Information - Licensing Action
Proper name: Daclizumab
Tradename: Zenapax
Manufacturer: Hoffman-La Roche Inc, Nutley, NJ, License #0136
Revised Package Insert: Include pediatric use and update the Clinical Pharmacology, Clinical Studies, and Adverse Reactions sections of the package insert with three year posttransplant data
Approval Date: 7/29/2002
Type of submission: Biologics license application supplement
Approval Letter (PDF)
Label (PDF)
Last Updated: 8/29/2002
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Date Updated: September 25, 2003 |
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