Drug Approval Package

Synthetic Conjugated Estrogens, A vaginal cream, 0.625 mg/g
Company: Duramed Research, Inc.
NDA: 021788
Approval Date: 11/28/2008

Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.

• Approvable Letter(s) (PDF)
  
  
• Approval Letter(s) (PDF)
  
  
• Printed Labeling (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)  
  
  
• Proprietary Name Review(s) (PDF)
  

• Administrative Document(s) and Correspondence (PDF)

Date created: April 22, 2009

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