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FDA Drug Application 203414 by TAKEDA PHARMS USA

Application Number203414
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
AP01/25/2013N34998000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203414Orig1s000ltr.pdf 1/30/2013
AP01/25/2013N35019000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203414s000lbl.pdf 1/30/2013
AP01/25/2013N35068000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM337729.pdf 2/5/2013
AP01/25/2013N39100000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203414Orig1s000TOC.cfm 4/18/2014
AP01/25/2013N39101000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203414Orig1s000SumR.pdf 4/18/2014
AP010/17/2013SCM       
AP04/5/2016SE845597003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022271Orig1s005,022426Orig1s003,203414Orig1s003ltr.pdf 4/7/2016
AP04/5/2016SE845615003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203414s003lbl.pdf 4/7/2016
AP08/21/2014SCM       
AP08/28/2015SLR43766005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022271Orig1s007,022426Orig1s005,203414Orig1s005ltr.pdf 9/1/2015
AP08/28/2015SLR43922005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203414s005lbl.pdf 9/21/2015




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