Drug Approval Package: Aveed (Testosterone Undecanoate)

Company:  Pfizer Central Research
Application No.:  022219 Orig 1
Approval Date: 3/5/2014

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• Approval Letter(s) (PDF)
• Other Action Letters (PDF)
• Printed Labeling (PDF)
• REMS (PDF)
• Summary Review (PDF)
• Officer/Employee List (PDF)
• Cross Discipline Team Leader Review (PDF)
• Medical Review(s) (PDF)
• Chemistry Review(s) (PDF)
• Pharmacology Review(s) (PDF)
• Statistical Review(s) (PDF)
• Microbiology Review(s) (PDF)
• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
• Risk Assessment and Risk Mitigation Review(s) (PDF)
• Proprietary Name Review(s) (PDF)
• Other Review(s) (PDF)
• Administrative and Correspondence Document(s) (PDF)

Date created: March 28, 2016

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