Drug Approval Package

Duavee (conjugated estrogens and bazedoxifene)
Company: Wyeth Pharmaceuticals, Inc.
Application No.: 022247
Approval Date: 10/3/2013

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

Date created: November 15, 2013

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