Drug Approval Package

 Depo-SubQ Provera 104 (Medroxyprogesterone Acetate) Injectable Suspension
Company: Pfizer, Inc.
Application No.:  021583
Approval Date: 02/17/2004

• Approval Letter(s) (PDF)  

• Approvable Letter (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)  

• Administrative Document(s) & Correspondence (PDF)  

Date created: May 09 , 2007

Back to Top    Drugs@FDA

Note: Documents in PDF format require the Adobe Acrobat Reader®.