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FDA Drug Application 017122 by XANODYNE PHARM

Application Number017122
Application Type New Drug Application
Sponsor ApplicantXANODYNE PHARM
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/19/1972N       
AP06/18/1974SCS       
AP09/15/1976SCE       
AP06/10/1977SLR       
AP05/6/1977SCP       
AP05/6/1977SCP       
AP01/21/1980SCS       
AP010/16/1978SCP       
AP06/29/1979SCF       
AP07/17/1979SLR       
AP011/6/1979SCM       
AP09/26/1979SLR       
AP04/16/1980SLR       
AP05/20/1981SLR       
AP010/28/1981SLR       
AP08/7/1984SLR       
AP08/16/1984SCS       
AP04/3/1986SLR       
AP04/21/1986SLR       
AP010/17/1986SLR       
AP04/16/1987SCS       
AP03/20/1995SLR       
AP08/23/1994SLR       
AP012/17/1993SCS       
AP09/15/1992SCS       
AP09/2/1994SLR       
AP04/5/1994SCM       
AP03/14/1995SCF       
AP010/30/2001SLR       
AP010/30/2001SLR       
AP05/15/1997SCS       
AP04/2/1998SCP       
AP08/10/1998SCS       
AP010/5/1998SCM       
AP02/24/1999SCM       
AP02/3/2005SCM       
AP02/3/2005SCM       
AP04/12/2005SCM       
AP07/13/2005SCM       
AP05/11/2006SCM       
AP01/24/2007SCS       
AP09/25/2009SLR23871061   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/010997s051,052,016862s041,042,017122s061,062ltr.pdf 11/13/2009
AP09/25/2009SLR23489061   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017122s061s062lbl.pdf 10/1/2009
AP09/25/2009SLR23495061   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM187067.pdf 10/1/2009
AP09/25/2009SLR23496062   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM187067.pdf 10/1/2009
AP09/25/2009SLR23690062   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/010997s051,052,016862s041,042,017122s061,062ltr.pdf 10/26/2009
AP09/25/2009SLR23490062   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017122s061s062lbl.pdf 10/1/2009




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