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U.S. Department of Health and Human Services

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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)