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FDA Drug Application 022271 by TAKEDA PHARMS USA

Application Number022271
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
AP01/25/2013N35000000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022271Orig1s000ltr.pdf 1/30/2013
AP01/25/2013N35017000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022271s000lbl.pdf 1/30/2013
AP01/25/2013N35070000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM337732.pdf 2/5/2013
AP01/25/2013N35508000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/022271Orig1s000TOC.cfm 3/25/2013
AP01/25/2013N35509000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/022271Orig1s000SumR.pdf 3/25/2013
AP05/30/2013SCM       
AP06/26/2013SCM       
AP08/15/2013SCM       
AP04/5/2016SE845595005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022271Orig1s005,022426Orig1s003,203414Orig1s003ltr.pdf 4/7/2016
AP04/5/2016SE845617005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022271s005lbl.pdf 4/7/2016
AP07/20/2015SCM       
AP08/28/2015SLR43764007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022271Orig1s007,022426Orig1s005,203414Orig1s005ltr.pdf 9/1/2015
AP08/28/2015SLR43921007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022271s007lbl.pdf 9/21/2015
AP04/19/2016SCM       
AP05/27/2016SLR46190009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022271Orig1s009ltr.pdf 5/31/2016
AP05/27/2016SLR46229009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022271s009lbl.pdf 6/1/2016




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