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2006P-0089: Stay Approval of all Supplements to Biologics Licenses Issued to Genentech (BLA# 103705 ) and Biogen (BLA# 103737) for Rituxan (Rituximab)

Document # Received Date Filed Date Submitter Code Submitter FR Date FR Page Comment Date Files Remarks
 
CP1 02/27/2006 02/27/2006 Private Industry Korein Tillery LLC       pdf  
Signature: Michael Bannester
ACK1 02/27/2006 02/27/2006 Federal Government
HFA-305 to Korein Tillery       pdf  
  Signature: Jennie C. Butler
LET1 03/21/2006 03/18/2006 Private Industry Genentech Inc       pdf  
Signature: Coleen Klasmeier
EC1 05/08/2006 03/13/2006 Individual Consumer Mr. Dave Lowe       htm  
C1 05/31/2006 05/25/2006 Individual Consumer D. Lowe          
C2 06/09/2006 06/09/2006 Drug Industry Genentech, Inc. (Genentech) and Idec, Inc. (Biogen)       pdf  
Signature: Stephen G. Juelsgaard and Susan H.
LET2 08/30/2006 08/30/2006 Federal Government FDA/CDER to Korein Tillery LLC       pdf  
  Signature: Jane A. Axelrad

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Page last updated October 3, 2006 kkhorizonal rule
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