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2004P-0074: Oxandrolone and Widely used Anti-coagulant Durgs Containing the Active Drug Warfarin

Document # Received Date Filed Date Submitter Code Submitter FR Date FR Page Comment Date Files Remarks
 
CP1 02/17/2004 02/18/2004 Drug Industry Savient Pharmaceuticalsl, Inc.      

Petition
Tab one, two, three, four, five, six

 
Signature: Edward John Allera
ACK1 02/18/2004 02/18/2004 Federal Government
HFA-305 to Savient Pharmaceuticals, Inc.       pdf  
  Signature: Lyle D. Jaffe
C1 08/05/2004 08/04/2004 Private Industry Heller Ehrman       Comment
Tab A, B, C
 
Signature: James N. Czaban
LET1 08/11/2004 08/11/2004 Federal Government
HFD-005 to Buchanan Ingersoll, P.C.       pdf  
  Signature: Jane A. Axelrad
SUP1 09/17/2004 09/17/2004 Private Industry Buchanan Ingersoll       pdf
Attachment one, two
 
Signature: Edward John Allera
 
C2 09/30/2004 09/28/2004 Private Industry Hyman, Phelps & McNamara PC       pdf  
Signature: Robert A Dormer, Josephine M Torren
C3 10/25/2004 10/22/2004 Private Industry Heller Ehrman       pdf  
Signature: James N. Czaban and Sanjay Sitlani
SUP2 11/09/2004 11/09/2004 Drug Industry Savient Pharmaceuticals       pdf  
Signature: Edward John Allerga
C4 12/06/2004 12/06/2004 Health Professional D. Flockhart, M.D., PhD       pdf  
SUP3 02/25/2005 02/25/2005 Drug Industry Savient Pharmaceuticalsl, Inc.       pdf  
Signature: Edward John Allera
C5 10/07/2005 10/07/2005 Drug Industry Savient Pharmaceuticals, Inc.       pdf  
Signature: Robert A. Dormer
SUP4 02/02/2006 02/02/2006 Drug Industry Savient Pharmaceuticals, Inc. (Savient)       pdf
Attachment
 
Signature: Edward John Allera
C6 02/27/2006 02/21/2006 Private Industry Hyman, Phelps & McNamara, P.C.       pdf  
Signature: Robert Robert A. Dormer and Josephi
 
C7 03/17/2006 03/14/2006 Individual Consumer D. Lowe          

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