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2006P-0398: Require Bioequivalence Studies for Generic or Follow-on Formulations of MEGACE ES (megestrol acetate oral suspension 625 mg/5 ml)

Document # Received Date Filed Date Submitter Code Submitter FR Date FR Page Comment Date Files Remarks
 
ACK1 09/29/2006 09/29/2006 Federal Government FDA/DDM to Frommer Lawrence & Haug, LLP       pdf  
  Signature: Jennie Butler
CP1 09/29/2006 09/29/2006 Private Industry Frommer Lawrence & Haug, LLP       pdf
Attachments
 
Signature: Charles J. Raubicheck
C1 10/11/2006 10/05/2006 Individual Consumer D Lowe          

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Page last updated October 19, 2006 kkhorizonal rule
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