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FDA Drug Application 202799 by TAKEDA PHARMS USA

Application Number202799
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
AP03/27/2012N32208000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202799s000lbl.pdf 3/27/2012
AP03/27/2012N32209000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM297877.pdf 3/27/2012
AP03/27/2012N32218000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202799Orig1s000ltr.pdf 3/27/2012
AP03/27/2012N32239000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=40 3/28/2012
AP03/27/2012N32609000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202799_Omontys_Orig1s000TOC.cfm 5/3/2012
AP012/4/2012SLR34550001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202799s001lbl.pdf 12/5/2012
AP012/4/2012SLR34564001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202799Orig1s001ltr.pdf 12/6/2012




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