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FDA Drug Application 010997 by XANODYNE PHARM

Application Number010997
Application Type New Drug Application
Sponsor ApplicantXANODYNE PHARM
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP08/16/1957N       
AP01/6/1975SLR       
AP07/23/1976SLR       
AP05/3/1977SCP       
AP05/3/1977SCP       
AP01/21/1980SCS       
AP02/27/1979SCE       
AP05/26/1978SCF       
AP010/13/1978SCP       
AP09/26/1979SLR       
AP04/15/1980SLR       
AP08/10/1981SCF       
AP05/20/1981SLR       
AP010/28/1981SLR       
AP01/28/1985SCS       
AP04/21/1986SLR       
AP04/21/1986SLR       
AP04/21/1986SLR       
AP011/5/1986SCS       
AP010/16/1986SLR       
AP012/8/1986SCS       
AP08/23/1994SLR       
AP09/15/1992SCS       
AP09/2/1994SLR       
AP08/1/2002SLR4751043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/10996slr061,%2010997slr043,%2016862slr033ltr.pdf 8/1/2002
AP04/2/1998SCP       
AP08/10/1998SCS       
AP010/5/1998SCM       
AP02/24/1999SCM       
AP09/25/2009SLR23478051   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/010997s051s052lbl.pdf 9/30/2009
AP09/25/2009SLR23493051   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM187068.pdf 10/1/2009
AP09/25/2009SLR23869051   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/010997s051,052,016862s041,042,017122s061,062ltr.pdf 11/13/2009
AP09/25/2009SLR23494052   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM187068.pdf 10/1/2009
AP09/25/2009SLR23500052REMS  http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/010997s051s052,016862s041s042REMS.pdf 10/1/2009
AP09/25/2009SLR23688052   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/010997s051,052,016862s041,042,017122s061,062ltr.pdf 10/26/2009
AP09/25/2009SLR23486052   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/010997s051s052lbl.pdf 10/1/2009




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