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FDA Drug Application 016023 by ENDO PHARMS

Application Number016023
Application Type New Drug Application
Sponsor ApplicantENDO PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP02/14/1968N       
AP01/7/1976SCS       
AP011/16/1977SCM       
AP08/10/1977SCM       
AP012/8/1982SCP       
AP01/4/1985SCP       
AP02/14/1986SLR       
AP01/16/1987SE1       
AP04/19/1993SE2       
AP010/23/1989SLR       
AP02/6/1992SCP       
AP02/4/1992SCM       
AP08/11/1992SCM       
AP01/5/1996SCS       
AP06/8/1999SCP       
AP012/6/2000SLR       
AP01/11/2002SCS       
AP011/18/2003SLR6947037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18101slr009,16023slr037ltr.pdf 11/25/2003
AP011/18/2003SLR8403037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/018101s009lbl.pdf 4/27/2004
AP011/18/2003SLR14070037   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/016023s037_018101s009_SymmetrelTOC.cfm 5/8/2006
AP03/2/2007SLR15975039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016023s039, 018101s014.pdf 3/7/2007
AP03/2/2007SLR15988039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016023s039,018101s014lbl.pdf 3/7/2007
AP09/24/2008SLR20888040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/016023s040, 018101s015ltr.pdf 9/26/2008
AP09/24/2008SLR20938040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016023s040,018101s015lbl.pdf 10/3/2008
AP02/2/2009SLR21701041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/016023s041,018101s016ltr.pdf 2/3/2009
AP02/2/2009SLR21746041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016023s041,018101s016lbl.pdf 2/4/2009




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