Filgrastim
Product Approval Information - Licensing Action
Proper name: Filgrastim
Tradename: Neupogen
Manufacturer: Amgen, Inc, Thousand Oaks, CA, License #1080
Revised Package Insert: Include updated information regarding adult respiratory distress syndrome and splenic rupture
Approval Date: 5/29/2002
Type of submission: Biologics license application supplement
Approval Letter (PDF)
Label (PDF)
Physicians Package Insert (PDF) - Part 1,
Part 2,
Part 3
Last Updated: 6/10/2003
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Updated: September 25, 2003 |