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FDA Drug Application 200175 by DAIICHI SANKYO

Application Number200175
Application Type New Drug Application
Sponsor ApplicantDAIICHI SANKYO
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP07/23/2010N29519000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200175_tribenzor_toc.cfm 7/15/2011
AP07/23/2010N29520000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200175Orig1s000SumR.pdf 7/15/2011
AP07/23/2010N26034000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/200175s000ltr.pdf 7/28/2010
AP07/23/2010N26049000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/200175s000lbl.pdf 7/30/2010
AP03/25/2011SLR28470001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200175s001ltr.pdf 4/6/2011
AP03/25/2011SLR28520001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200175s001lbl.pdf 4/11/2011
AP06/21/2011SLR29267003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200175s003ltr.pdf 6/27/2011
AP06/21/2011SLR29344003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200175s003lbl.pdf 6/29/2011
AP011/1/2011SLR30487007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200175s007ltr.pdf 11/3/2011
AP011/1/2011SLR30501007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200175s007lbl.pdf 11/4/2011
AP01/19/2012SLR31444008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200175s008lbl.pdf 1/23/2012
AP01/19/2012SLR31456008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200175s008ltr.pdf 1/23/2012
AP02/1/2013SCM       
AP09/28/2012SLR33914011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200175s011lbl.pdf 10/2/2012
AP09/28/2012SLR33952011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200175Orig1s011ltr.pdf 10/3/2012
AP012/10/2012SLR34595012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200175Orig1s012ltr.pdf 12/11/2012
AP012/10/2012SLR34663012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200175s012lbl.pdf 12/14/2012
AP05/6/2013SCM       
AP07/3/2013SCM       
AP07/3/2013SLR36452015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200175Orig1s015ltr.pdf 7/5/2013
AP07/3/2013SLR36463015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200175s015lbl.pdf 7/5/2013
AP06/20/2014SCM       
AP06/13/2014SLR39561018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200175s018lbl.pdf 6/17/2014
AP06/13/2014SLR39576018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200175Orig1s018ltr.pdf 6/18/2014
AP06/27/2014SLR39700019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200175Orig1s019ltr.pdf 6/30/2014
AP06/27/2014SLR39707019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200175s019lbl.pdf 7/1/2014
AP09/23/2014SLR40593020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200175Orig1s020ltr.pdf 9/24/2014
AP09/23/2014SLR40621020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200175s020lbl.pdf 9/26/2014
AP09/16/2015SCM       




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