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2006P-0285: Refrain from Granting any Bioequivalence Waiver for any ANDA Referencing Duramed's NDA 21-544 for Seasonal

Document # Received Date Filed Date Submitter Code Submitter FR Date FR Page Comment Date Files Remarks
 
ACK1 07/17/2006 07/17/2006 Federal Government FDA/DDM to Duramed Research, Inc.       pdf  
  Signature: Gloria Ortega
CP1 07/14/2006 07/14/2006 Private Industry Duramed Research, Inc.       pdf  
Signature: Joseph A. Carrado, M.Sc., R.Ph.

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Page last updated August 9, 2006 kkhorizonal rule
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