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2005N-0345: Drug Approvals: Circumstances under which an Active Ingredient may be Simultaneously Marketed in both a Prescription Drug Product and an Over-the-Counter Drug Product
Document # Received Date Filed Date Submitter Code Submitter FR Date FR Page Comment Date Files Remarks
 
NAP1   08/26/2005 FDA FDA 09/01/2005 52050-52051 11/01/2005 pdf  
Signature: Jeffrey Shuren
EC1 08/29/2005 08/27/2005 Individual Consumer Dr. Kathleen Frydl       htm  
EC2 08/29/2005 08/27/2005 Individual Consumer Mrs. Joan Casadonte       htm  
EC3 08/29/2005 08/28/2005 Individual Consumer Mrs. Mary Ann Pollock       htm  
EC4 08/29/2005 08/27/2005 Individual Consumer Mr. Michael Bilz       htm  
EC5 08/29/2005 08/27/2005 Individual Consumer Miss. LAURA CUNNINGHAM       htm  
EC6 08/29/2005 08/27/2005 Individual Consumer Mr. Evan Goodman       htm  
EC7 08/29/2005 08/28/2005 Individual Consumer Ms. Jennifer Dawson       htm  
EC8 08/29/2005 08/28/2005 Individual Consumer Ms. Megan MacBride       htm  
EC9 08/29/2005 08/28/2005 Health Professional Dr. TRACI CORDER       htm  
C1 08/26/2005 08/26/2005 Health Professional P. Aiello, MD          
EC10 09/01/2005 08/29/2005 Individual Consumer Mrs. Marion Blumenstock       htm  
EC11 09/01/2005 08/29/2005 Individual Consumer Mr. William Rivkin       htm  
EC12 09/01/2005 08/29/2005 Health Professional UCLA Medical Center, Dept of Pharm Serv       htm  
Signature: Reynolds, Charles
EC13 09/01/2005 08/29/2005 Individual Consumer Mr. Alexander Clague       htm  
EC14 09/01/2005 08/29/2005 Individual Consumer Mr. irwin seltzer       htm  
EC15 09/01/2005 08/29/2005 Individual Consumer Ms. Laura Marshall       htm  
EC16 09/01/2005 08/29/2005 Health Professional Ms. Stephanie Smart       htm  
EC17 09/01/2005 08/29/2005 Individual Consumer Mr. Rick LaChance       htm  

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