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FDA Drug Application 203469 by ARIAD

Application Number203469
Application Type New Drug Application
Sponsor ApplicantARIAD
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
AP012/14/2012N34659000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203469lbl.pdf 12/14/2012
AP012/14/2012N34691000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203469s000mg.pdf 12/18/2012
AP012/14/2012N34707000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203469Orig1s000ltr.pdf 12/19/2012
AP012/14/2012N34730000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203469Orig1s000TOC.cfm 12/21/2012
AP012/14/2012N34732000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203469Orig1s000SumR.pdf 12/21/2012
AP012/14/2012N38123000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=186 12/20/2013
AP012/14/2012N38450000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm383276.htm 2/4/2014
AP06/25/2013SCM       
AP08/12/2013SCM       
AP01/30/2014SCM       
AP03/27/2014SCM       
AP012/20/2013SLR38122007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203469Orig1s007,s008ltr.pdf 12/20/2013
AP012/20/2013SLR39764007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203469Orig1s007,s008.pdf 7/7/2014
AP012/20/2013SLR38117007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203469s007s008lbl.pdf 12/20/2013
AP012/20/2013SLR38118007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203469s007s008mg.pdf 12/20/2013
AP012/20/2013SLR38119008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203469s007s008lbl.pdf 12/20/2013
AP012/20/2013SLR38120008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203469s007s008mg.pdf 12/20/2013
AP012/20/2013SLR38121008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203469Orig1s007,s008ltr.pdf 12/20/2013
AP012/20/2013SLR39765008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203469Orig1s007,s008.pdf 7/7/2014
AP07/24/2014SLR40009009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203469s009lbl.pdf 7/28/2014
AP07/24/2014SLR40010009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203469Orig1s009ltr.pdf 7/28/2014
AP07/30/2014SCM       
AP08/15/2014SCM       
AP09/9/2014SCM       
AP01/20/2015SCM       
AP02/3/2015SCM       
AP05/20/2015SCM       
AP04/17/2015SCM       
AP04/23/2015SCM       
AP08/24/2015SCM       
AP012/1/2015SCM       
AP012/2/2015SLR44661020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203469Orig1s020ltr.pdf 12/3/2015
AP012/2/2015SLR44693020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203469s020lbl.pdf 12/8/2015
AP06/2/2016SE846261021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203469s021lbl.pdf 6/6/2016
AP06/2/2016SE846263021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203469Orig1s021ltr.pdf 6/6/2016
AP08/31/2016SLR46946023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203469Orig1s023ltr.pdf 9/2/2016
AP08/31/2016SLR46963023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203469s023lbl.pdf 9/2/2016
AP09/7/2016SLR46992024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203469Orig1s024ltr.pdf 9/8/2016
AP09/7/2016SLR47033024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203469s024lbl.pdf 9/12/2016




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