2005P-0406
  

  
 Benzphetamine Hydrochloride Capsule, 50 mg drug product is suitable for submission as an ANDA

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC1
  



  

  
Submitter : 
  

  
Mr. Dave Lowe
  

  
Date & Time: 
  

  
02/01/2006 01:02:17
  



  

  
Organization : 
  

  
Mr. Dave Lowe
  



  

  
Category : 
  

  
Individual Consumer
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 10/26/1960 is the approval date for Didrex. Didrex needs a new owner since owned by Pharmicia and Upjohn. Pfizer I suspect has no patent again.

NDA no. 012427 has never had clinical investigations as this was approved prior to legislation mandating efficacy be demonstrated. Remove Didrex, and all products which reference it from the market for efficacy reasons.