2006P-0086
  

  
 To declare that the drug product, Butalbital, 50 mg and acetaminophen, 300 mg Tablets, is suitable for consideration in an abbreviated new drug application (ANDA).

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC1
  



  

  
Submitter : 
  

  
Mr. Dave Lowe
  

  
Date & Time: 
  

  
08/02/2006 04:08:44
  



  

  
Organization : 
  

  
Mr. Dave Lowe
  



  

  
Category : 
  

  
Individual Consumer
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 Safety and efficacy must be established outside the Federal Register. Also included to read is 374 pages regarding Legislative Power (Article 1). I oppose the petition.

  


  

  


  

  



  

  
2006P-0086-EC1-Attach-1.PDF