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2005P-0456: Determine that the Discontinued Formulation Zosyn (Piperacillin and Tazobactam for Injection), was not Discontinued for Safety and Efficacy Reasons

Document # Received Date Filed Date Submitter Code Submitter FR Date FR Page Comment Date Files Remarks
 
CP1 11/08/2005 11/08/2005 Private Industry Sandoz Inc.       Table of Contents  
Signature: Beth Brannan
ACK1 11/08/2005 11/08/2005 Federal Government
HFA-305 to Sandoz Inc.       pdf  
Signature: Jennie C. Butler
C1 01/20/2006 01/20/2006 Drug Industry Wyeth Pharmaceuticals       pdf  
Signature: Geoffrey M. Levitt
SUP1 03/02/2006 03/01/2006 Private Industry Sandoz Inc.       pdf  
Signature: Brian Andresen
C2 05/01/2006 05/01/2006 Drug Industry Abraxis Pharmaceutical Products       pdf  
Signature: Shahid Ahmed
C3 05/01/2006 04/27/2006 Individual Consumer D. Lowe        
C4 05/04/2006 05/04/2006 Drug Industry Wyeth Pharmaceuticals       pdf  
Signature: Geoffrey M. Levitt
LET1 05/05/2006 05/05/2006 Federal Government
FDA/CDER to Sandoz Inc.       pdf  
Signature: Jane A. Axelrad
 
C5 05/09/2006 05/09/2006 Private Industry Rakoczy Molino Mazzochi Siwik, LLP (RMMS)       pdf
Ex A, Ex B
 
Signature: William A. Rakoczy and Christine J. Si
C6 05/22/2006 05/17/2006 Individual Consumer D. Lowe          
C7 07/19/2006 07/19/2006 Drug Industry Wyeth Pharmaceuticals       pdf  
Signature: Geoffrey M. Levitt

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