Drug Approval Package

Mylotarg (gemtuzumab ozogamicin) Injection
Company:  Wyeth-Ayerst
Application No.:  21-174
Approval Date: 5/17/2000

• Approval Letter(s)(PDF)  

• Printed Labeling(PDF)  

• Medical Review(s)(PDF)  

• Chemistry Review(s)(PDF)  

• Pharmacology Review(s)

  Part 1(PDF)
  Part 2(PDF)

• Statistical Review(s)(PDF)  

• Microbiology Review(s)(PDF)  

• Clinical Pharmacology Biopharmaceutics Review(s)(PDF)  

• Administrative Document(s)(PDF)  

• Correspondence(PDF)  

Date created: June 18, 2001

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