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FDA Drug Application 017111 by ENDO PHARMS

Application Number017111
Application Type New Drug Application
Sponsor ApplicantENDO PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP01/18/1974N       
AP09/23/1974SCS       
AP09/20/1976SLR       
AP08/26/1976SCP       
AP03/14/1977SCS       
AP05/27/1977SCP       
AP02/7/1977SCF       
AP02/7/1977SCF       
AP06/7/1977SCS       
AP01/5/1981SCF       
AP012/20/1979SCE       
AP05/10/1979SLR       
AP09/27/1979SCP       
AP08/16/1979SLR       
AP01/6/1981SCF       
AP03/24/1981SLR       
AP011/19/1982SLR       
AP06/26/1985SCP       
AP06/11/1986SCP       
AP09/23/1987SCM       
AP06/28/1988SCP       
AP06/28/1988SLR       
AP08/8/1988SCM       
AP08/12/1994SCM       
AP08/28/1995SCS       
AP08/28/1995SCS       
AP08/28/1995SCS       
AP04/25/1996SCS       
AP08/21/1998SCM       
AP08/21/1998SCS       
AP05/22/2001SLR5115055   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17111s55ltr.pdf 4/9/2003
AP03/12/2008SLR19467062   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017111s062ltr.pdf 3/17/2008
AP03/12/2008SLR19472062   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017111s062lbl.pdf 3/17/2008
AP08/14/2008SLR20622063   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017111s063ltr.pdf 8/19/2008
AP08/14/2008SLR20710063   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017111s063lbl.pdf 8/29/2008
AP07/19/2009SLR23022066   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017111s066lbl.pdf 7/23/2009
AP07/19/2009SLR23026066   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017111s066ltr.pdf 7/23/2009
AP012/1/2010SLR27183067   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017111s067lbl.pdf 12/4/2010
AP012/1/2010SLR27197067   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/017111s067ltr.pdf 12/6/2010




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