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FDA Drug Application 021610 by ENDO PHARMS

Application Number021610
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 Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP06/22/2006N36164000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17 5/31/2013
AP08/2/2006SLR14588001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021610s001,021611s001lbl.pdf 8/4/2006
AP08/2/2006SLR14632001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021610s001, 021611s001LTR.pdf 8/7/2006
AP07/9/2007SLR17271003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021610s003lbl.pdf 7/10/2007
AP07/9/2007SLR17277003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021610s003ltr.pdf 7/16/2007
AP01/10/2008SCS18897005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021610s005lbl.pdf 1/18/2008
AP01/10/2008SCS18908005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021610s005ltr.pdf 1/18/2008
AP02/29/2008SCM19369006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021610s006lbl.pdf 3/5/2008
AP02/29/2008SCM19382006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021610s006ltr.pdf 3/5/2008
AP010/4/2010SLR26609009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021610s009lbl.pdf 10/4/2010
AP010/4/2010SLR26638009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021610s009ltr.pdf 10/12/2010
AP07/9/2012SLR33139012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021610Orig1s012ltr.pdf 7/11/2012
AP07/9/2012SLR33162012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021610s012lbl.pdf 7/12/2012
AP07/9/2012SLR33167013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021610Orig1s013ltr.pdf 7/13/2012
AP07/9/2012SLR33183013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021610s013lbl.pdf 7/13/2012
AP04/15/2013SLR35742014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021610Orig1s014ltr.pdf 4/18/2013
AP02/23/2014SCM       
AP04/16/2014SLR39062018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021610s018lbl.pdf 4/16/2014
AP04/16/2014SLR39080018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021610Orig1s018ltr.pdf 4/17/2014
AP08/19/2014S40274019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021610Orig1s019ltr.pdf 8/20/2014
AP06/26/2015S43230020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021610Orig1s020ltr.pdf 7/6/2015
AP04/20/2016S45720021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021610Orig1s021ltr.pdf 4/22/2016
AP09/30/2016S47269023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021610Orig1s023ltr.pdf 10/4/2016




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