Drug Approval Package
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U.S. Department of Health and Human Services

Drug Approval Package
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Taclonex (Calcipotriene and Betamethasone dipropionate) Ointment
Company: Parexel International
Application No.:  021852
Approval Date: 01/09/2006

  • Approval Letter(s) (PDF)  
    Vision impaired people having problems accessing certain pages of the above PDF file may call (301) 796-3634 for assistance.

  • Proprietary Name Review(s) (PDF)  
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  • Summary Review (PDF)  
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  • Printed Labeling (PDF)  
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  • Medical Review(s)
    Part 1 (PDF)  
    Part 2 (PDF)  
    Vision impaired people having problems accessing certain pages of the above PDF file may call (301) 796-3634 for assistance.

  • Chemistry Review(s) (PDF)  
    Vision impaired people having problems accessing certain pages of the above PDF file may call (301) 796-3634 for assistance.

  • Pharmacology Review(s) (PDF)  
    Vision impaired people having problems accessing certain pages of the above PDF file may call (301) 796-3634 for assistance.

  • Statistical Review(s) (PDF)  
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  • Microbiology Review(s) (PDF)  
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  • Clinical Pharmacology Biopharmaceutics Review(s) (PDF)  
    Vision impaired people having problems accessing certain pages of the above PDF file may call (301) 796-3634 for assistance.

  • Administrative Document(s) & Correspondence (PDF)  
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Date created: March 24, 2008

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