Drug Approval Package

Elestrin (estradiol gel)
Company:  BioSante Pharmaceuticals, Inc.
Application No.:  021813
Approval Date: 12/15/2006

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• Approval Letter(s) (PDF)
• Summary Review (PDF)
• Printed Labeling (PDF)
• Medical Review(s)
  • Part 1 (PDF)
  • Part 2 (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)
• Administrative Document(s) & Correspondence (PDF)

Date created: June 9, 2009

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