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2005P-0383: Refuse to Approve any ANDA for Generic Oral Products Containing Oxandrolone until the Expiration OD that Exclusitity Peroid on June 20, 2008
Document # Received Date Filed Date Submitter Code Submitter FR Date FR Page Comment Date Files Remarks
 
CP1 09/19/2005 09/20/2005 Drug Industry Savient Pharmaceuticals, Inc.       pdf  
Signature: Edward John Allera and Theodore Su
ACK1 09/20/2005 09/20/2005 Federal Government
 HFA-305 to Savient Pharmaceuticals, Inc.       pdf  
  Signature: Lyle D. Jaffe
C1 10/17/2005 10/17/2005 Private Industry Hyman, Phelps & McNamara, P.C.       pdf  
Signature: Robert A. Dormer and Josephine M. T
 
CR1 10/18/2005 10/18/2005 Private Industry Hyman, Phelps & McNamara, P.C.       pdf Correction to C 1 found in this docket.
Signature: Josephine M. Torrente  
 
SUP1 02/02/2006 02/02/2006 Drug Industry Savient Pharmaceuticals, Inc.       pdf  
Signature: Edward John Allera
C2 02/27/2006 02/21/2006 Private Industry Hyman, Phelps & McNamara, P.C.       pdf  
Signature: Robert A. Dormer and Josephine M. T
C3 03/03/2006 03/01/2006 Private Industry Frommer Lawrence & Haug, LLP       pdf  
Signature: Charles J. Raubicheck
LET1 03/21/2006 03/21/2006 Federal Government
 HFD-005 to Buchanan Ingersoll       pdf  
  Signature: Jane A. Axelrad
RC1 04/25/2006 04/25/2006 Drug Industry Savient Pharmaceuticals, Inc.       pdf  
Signature: Edward John Allera
PDN1 12/01/2006 12/01/2006 Federal Government FDA/CDER to Buchanan Ingersoll PC on behald of Savient Pharmaceuticals Inc       pdf  
Signature: Steven K Galson MD MPH
PRC1 12/05/2006 12/05/2006 Private Industry Savient Pharmaceuticals Inc       Table of Contents  
Signature: Edward John Allerga, Theodore M Su
ACK2 12/05/2006 12/05/2006 Federal Government FDA/DDM to Savient Pharmaceuticals Inc       pdf  
  Signature: Jennie C Butler

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