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FDA Drug Application 016862 by XANODYNE PHARM

Application Number016862
Application Type New Drug Application
Sponsor ApplicantXANODYNE PHARM
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP09/9/1971N16203000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/016862_DARVON_N_ORIGINAL_AP.pdf 4/9/2007
AP09/9/1971N23944000REMS  http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/010997s051s052,016862s041s042REMS.pdf 11/18/2009
AP01/21/1980SCS       
AP010/13/1977SCP       
AP010/13/1977SCP       
AP01/11/1978SLR       
AP07/24/1980SCF       
AP09/26/1979SLR       
AP01/27/1981SLR       
AP06/8/1981SLR       
AP08/16/1984SCS       
AP04/21/1986SLR       
AP04/16/1985SCS       
AP012/31/1985SLR       
AP04/18/1986SCS       
AP010/16/1986SLR       
AP04/15/1987SCS       
AP08/23/1994SLR       
AP09/15/1992SCS       
AP09/2/1994SLR       
AP04/5/1994SCM       
AP08/1/2002SLR8882033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/10996slr061,%2010997slr043,%2016862slr033ltr.pdf 6/2/2004
AP04/2/1998SCP       
AP08/10/1998SCS       
AP010/5/1998SCM       
AP02/24/1999SCM       
AP09/25/2009SLR23870041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/010997s051,052,016862s041,042,017122s061,062ltr.pdf 11/13/2009
AP09/25/2009SLR23487041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016862s041s042lbl.pdf 10/1/2009
AP09/25/2009SLR23491041   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM187068.pdf 10/1/2009
AP09/25/2009SLR23689042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/010997s051,052,016862s041,042,017122s061,062ltr.pdf 10/26/2009
AP09/25/2009SLR23488042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016862s041s042lbl.pdf 10/1/2009




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