Drug Approval Package

 Plan B (0.75mg levonorgestrel)
Company: Duramed Research
Application No.: 21045/S011
Approval Date: 8/24/2006

• Approval Letter(s) (PDF)
• Printed Labeling (PDF)  
• Medical Review(s) (PDF)
• Chemistry Review(s) (PDF)  
• Statistical Review(s) (PDF)  
• Clinical Pharmacology Biopharmaceutics Review(s) (PDF) 
• Administrative Document(s) & Correspondence (PDF)  

Date created  August 29, 2006

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