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U.S. Department of Health and Human Services


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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 3