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2007N-0389: Granisetron Hydrochloride Injection and 180-day Generic Drug Exclusivity

Document # Received Date Filed Date Submitter Code Submitter FR Date FR Page Comment Date Files Remarks
LET1 10/11/2007 10/11/2007 Private Industry Teva Parenteral Medicines, Inc.       pdf  
Signature: Marc Goshko
LET2 10/16/2007 10/16/2007 Federal Government FDA/CDER/OGD       pdf  
Signature: Gary J. Buehler
C1 10/25/2007 10/25/2007 Private Industry WINSTON & STRAWN LLP       pdf  
Signature: James F. Hurst
EC1 10/31/2007 10/25/2007 Drug Industry Baxter Healthcare Corporation       pdf  
Signature: Polen, Tom
C2 10/31/2007 10/31/2007 Private Industry A. Tsien        
C3 11/01/2007 11/01/2007 Individual Consumer D. G. Adams        
LET3 1/23/2008 1/23/2008 Federal Government D. G. Adams       pdf  
Signature: Gary J. Buehler

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Page last updated: January 23, 2008