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FDA Drug Application 022426 by TAKEDA PHARMS USA

Application Number022426
Application Type New Drug Application
Sponsor ApplicantTAKEDA PHARMS USA
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP11/25/2013N35140000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM337733.pdf 2/12/2013
AP11/25/2013N35141000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022426s000lbl.pdf 2/12/2013
AP11/25/2013N35142000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022426Orig1s000Ltr_1_.pdf 2/12/2013
AP11/25/2013N35143000Original Letter  http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022426Orig1s000ltr.pdf 2/12/2013
AP11/25/2013N39091000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/022426Orig1s000TOC.cfm 4/17/2014
AP08/15/2013SCM       
AP04/5/2016SE845596003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022271Orig1s005,022426Orig1s003,203414Orig1s003ltr.pdf 4/7/2016
AP04/5/2016SE845616003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022426s003lbl.pdf 4/7/2016
AP03/17/2016SCM       
AP08/28/2015SLR43765005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022271Orig1s007,022426Orig1s005,203414Orig1s005ltr.pdf 9/1/2015
AP08/28/2015SLR43920005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022426s005lbl.pdf 9/21/2015




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