Epoetin alfa Product Approval Information - Licensing Action 7/26/99
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)
Label (PDF)
Reviews
Medical Review
Statistical Review
Clinical Pharmacology Review: Pharmacokinetics
Adverse Events List (PDF)