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FDA Drug Application 202192 by INCYTE CORP

Application Number202192
Application Type New Drug Application
Sponsor ApplicantINCYTE CORP
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP011/16/2011N30596000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202192lbl.pdf 11/16/2011
AP011/16/2011N30598000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202192s000ltr.pdf 11/16/2011
AP011/16/2011N31371000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202192Orig1s000TOC.cfm 1/9/2012
AP011/16/2011N31372000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202192Orig1s000SumR.pdf 1/9/2012
AP06/21/2012SLR32984001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202192s001lbl.pdf 6/22/2012
AP06/21/2012SLR32986001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202192s001ltr.pdf 6/25/2012
AP06/12/2013SE836286003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202192Orig1s003ltr.pdf 6/13/2013
AP06/12/2013SE836315003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202192s003lbl.pdf 6/18/2013
AP011/7/2013SCM       
AP011/25/2013SLR37934005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202192s005lbl.pdf 11/26/2013
AP011/25/2013SLR37944005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202192Orig1s005ltr.pdf 11/27/2013
AP07/25/2014SE840013006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202192s006lbl.pdf 7/28/2014
AP07/25/2014SE840016006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202192Orig1s006ltr.pdf 7/28/2014
AP05/30/2014SCM       
AP012/4/2014SE841155008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202192s008lblPi.pdf 12/4/2014
AP012/4/2014SE841169008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202192Orig1s008ltr.pdf 12/5/2014
AP012/15/2014SLR41263009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202192Orig1s009ltr.pdf 12/16/2014
AP012/15/2014SLR41266009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202192s009lbl.pdf 12/16/2014
AP012/2/2015SCM       
AP010/6/2015SCM       
AP03/10/2016SE845424012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202192Orig1s012ltr.pdf 3/14/2016
AP03/10/2016SE845444012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202192s012lbl.pdf 3/15/2016




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