Drug Approval Package

Plan B One-Step (levonorgestrel) tablet, 1.5 mg
Company: Duramed Pharmaceuticals, Inc.
Application No.: 021998
Approval Date: 7/10/2009

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• Approval Letter(s) (PDF)
• Summary Review (PDF)
• Officer/Employee List (PDF)
• Cross Discipline Team Leader 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)
• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
• Proprietary Name Review(s) (PDF)
• Other Action Letter(s) (PDF)
• Other Review(s) (PDF)
• Administrative Document(s) & Correspondence (PDF)

Date created: November 24, 2009

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