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FDA Drug Application 204447 by TAKEDA PHARMS USA

Application Number204447
Application Type New Drug Application
Sponsor ApplicantTAKEDA PHARMS USA
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP09/30/2013N37293000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204447s000lbl.pdf 10/1/2013
AP09/30/2013N37311000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204447Orig1s000ltr.pdf 10/2/2013
AP09/30/2013N37318000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM370633.pdf 10/3/2013
AP09/30/2013N37618000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204447Orig1s000TOC.cfm 10/30/2013
AP09/30/2013N37619000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204447Orig1s000SumR.pdf 10/30/2013
AP012/3/2013SCM       
AP01/20/2015SCM       
AP09/30/2014SCM       
AP09/8/2014SCM40456004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204447s004lbl.pdf 9/9/2014
AP07/17/2014SLR39895005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204447Orig1s005ltr.pdf 7/21/2014
AP07/17/2014SLR40056005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204447s005lbl.pdf 7/29/2014
AP05/2/2016SLR45847007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204447s007lbl.pdf 5/3/2016
AP05/2/2016SLR45859007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204447Orig1s007ltr.pdf 5/4/2016
AP08/30/2016SLR46938011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204447Orig1s011ltr.pdf 9/2/2016
AP08/30/2016SLR46955011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204447s011lbl.pdf 9/2/2016
AP010/17/2016SLR47389012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204447Orig1s012ltr.pdf 10/19/2016
AP010/17/2016SLR47395012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204447s012lbl.pdf 10/19/2016




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