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FDA Drug Application 203568 by KASTLE THERAPS LLC

Application Number203568
Application Type New Drug Application
Sponsor ApplicantKASTLE THERAPS LLC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP01/29/2013N35012000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=27 1/30/2013
AP01/29/2013N35020000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203568s000lbl.pdf 1/30/2013
AP01/29/2013N35021000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203568Orig1s000ltr.pdf 1/31/2013
AP01/29/2013N35069000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM337730.pdf 2/5/2013
AP01/29/2013N35269000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203568Orig1s000TOC.cfm 2/27/2013
AP01/29/2013N35270000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203568Orig1s000SumR.pdf 2/27/2013
AP05/7/2014S39262002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203568Orig1s002ltr.pdf 5/9/2014
AP02/26/2015SLR41941004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203568Orig1s004ltr.pdf 2/27/2015
AP02/26/2015SLR41992004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203568s004lbl.pdf 3/3/2015
AP07/28/2015S43515005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203568Orig1s005ltr.pdf 7/29/2015
AP07/1/2015SCM       
AP07/8/2015SCM       
AP05/20/2016SLR46145008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203568s008lbl.pdf 5/25/2016
AP05/20/2016SLR46153008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203568Orig1s008ltr.pdf 5/25/2016




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