2006P-0209
  

  
 Safety or Efficacy of Diastat (diazepam rectal gel), 5 mg/ml, 10mg/2 ml, 15 mg/3 ml and 20 mg/4 ml

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC14
  



  

  
Submitter : 
  

  
Mr. D Lowe
  

  
Date & Time: 
  

  
08/02/2006 11:08:37
  



  

  
Organization : 
  

  
Mr. D Lowe
  



  

  
Category : 
  

  
Individual Consumer
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 I oppose the petition in part. Also, Tofranil-PM's website is claiming generics (ANDA's) are available, but marketing the product. 100 times out of 100, the law states the NDA is misbranded, and those ANDA's are misbranded with no RLD. Remove the website with an injunction if needed. File uploaded twice - I think the eggs got me excited.

  


  

  


  

  


  

  



  

  
2006P-0209-EC14-Attach-1.PDF
  



  

  
2006P-0209-EC14-Attach-2.PDF