2006P-0387
  

  
Declare That Clobetasol Propionate from, 0.05b0is suitable for submission in an ANDA.
  


  

  

  


  

  
FDA Comment Number : 
  

  
EC1
  



  

  
Submitter : 
  

  
Mr. Dave Lowe
  

  
Date & Time: 
  

  
10/18/2006 10:10:45
  



  

  
Organization : 
  

  
Mr. Dave Lowe
  



  

  
Category : 
  

  
Individual Consumer
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
  There are numerous branded names and no petition is available. Temovate and Tamovate E prescribing information is available as Attachment One and Attachment Two. Attachment Three is an electronic Orange Book search for 'Clobetasol Propionate', also showing showing Clobetasol Propionate and Temovate are available for purchase. All should be misbranded, and any action keeping all approved drugs withdrawn. I oppose the petition.

  


  

  


  

  


  

  


  

  



  

  
2006P-0387-EC1-Attach-1.PDF
  



  

  
2006P-0387-EC1-Attach-2.PDF
  



  

  
2006P-0387-EC1-Attach-3.PDF