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2004P-0557: ANDA for a Generic Version of Efudex Cream(fluorouracil) Cream

Document # Received Date Filed Date Submitter Code Submitter FR Date FR Page Comment Date Files Remarks
 
CP1 12/21/2004 12/22/2004 Drug Industry Valeant Pharmaceuticals International       Table of Contents  
Signature: Dr. Kim D. Lamon,Dr. Grag J. Kricorian
ACK1 12/21/2004 12/21/2004 Federal Government
HFA-305 to Valeant Pharmaceuticals International       pdf  
Signature: Lyle D. Jaffe
LET1 06/17/2005 06/17/2005 Federal Government
HFD-5 to Valeant Pharmaceuticals International       pdf  
  Signature: Jane A Axelrad
C1 09/16/2005 09/16/2005 Private Industry Rothwell Figg Ernst & Manbeck PC       pdf  
Signature: Stephen Lieberman
LET2 10/07/2005 10/07/2005 Drug Industry Valeant Pharmaceuticals International       pdf  
Signature: Brian R McCormick
RC1 10/21/2005 10/21/2005 Drug Industry Valeant Pharmaceuticals International       pdf
Tabs
 
Signature: Kim D. Lamon, M.D., PhD and Greg J
C2 01/03/2006 01/03/2006 Private Industry Rothwell Figg Ernst & Manbeck       Table of Contents  
Signature: Steven Lieberman
LET3 01/13/2006 01/13/2006 Private Industry Hogan & Hartson, LLP       pdf  
Signature: David M. Fox
RC2 04/03/2006 04/03/2006 Drug Industry Valeant Pharmaceuticals International       Table of Contents  
Signature: Greg J. Kricorian, M.D.
OB1 04/28/2006 04/24/2006 Individual Consumer D. Lowe          
C3 05/05/2006 05/05/2006 Private Industry Rothwell Figg Ernst & Manbeck       pdf
Appendices
 
Signature: Steven Lieberman
LET4 05/31/2006 05/31/2006 Drug Industry Valeant Pharmaceuticals International       pdf  
Signature: David M. Fox
RC3 07/13/2006 07/13/2006 Drug Industry Valeant Pharmaceuticals International       pdf
Tab 1
 
Signature: Greg J. Kricorian, M.D.

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