Drug Approval Package

 PREMPRO (conjugated estrogens
/medroxyprogesterone acetate tablets) and PREMPHASE (conjugated estrogens/medroxyprogesterone acetate
tablets).
Company:  Wyeth Pharmaceuticals
Application No.:  020527-S17
Approval Date: 3/12/2003

• Approval Letter(s) (PDF)  

• Printed Labeling (PDF)  

• Medical Review(s) (PDF)

• Chemistry Review(s) (PDF)  

• Pharmacology Review(s) (PDF)  

• Statistical Review(s) (PDF)  

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)  

• Administrative Document(s) & Correspondence (PDF)  
  Part 1 (PDF)  
  Part 2 (PDF)  
  Part 3 (PDF)

Date created: September 11, 2003

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