Epoetin alfa
Product Approval Information - Licensing Action
Proper name: Epoetin alfa
Tradename: Epogen, Procrit
Manufacturer: Amgen, Inc, Thousand Oaks, CA, License #1080
Indication for Use: Pediatric Use
Approval Date: 7/26/99
Type of submission: Biologics license supplement
Approval Letter (PDF),
(Text)
Label (PDF)
Reviews
Medical Review
Statistical Review
Clinical Pharmacology Review: Pharmacokinetics
Adverse Events List (PDF)
Last Updated: 3/5/2001
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Updated: September 25, 2003 |