Filgrastim
Product Approval Information - Licensing Action
Proper name: Filgrastim
Tradename: Neupogen
Manufacturer: Amgen, Inc, Thousand Oaks, CA, License #1080
Indication for Use: New indication for use in patients with acute myeloid leukemia
Approval Date: 4/2/98
Type of submission: Biologics license application supplement
Approval Letter (Text),
(PDF)
Label (PDF)
Reviews - (PDF)
Biostatistical (7 pages)
Clinical (20 pages)
Last Updated: 3/5/2001
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Updated: September 25, 2003 |