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FDA Drug Application 022352 by TAKEDA PHARMS USA

Application Number022352
Application Type New Drug Application
Sponsor ApplicantTAKEDA PHARMS USA
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type Drug already marketed, but without an approved NDA
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP07/29/2009N23096000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022352lbl.pdf 7/30/2009
AP07/29/2009N23134000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022352s000ltr.pdf 8/6/2009
AP07/29/2009N24812000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022352_colcrys_toc.cfm 2/17/2010
AP07/29/2009N24813000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022352s000_SumR.pdf 2/17/2010
AP07/29/2009N25548000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM176363.pdf 5/14/2010
AP04/29/2010SLR25466004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022352s004ltr.pdf 5/6/2010
AP04/29/2010SLR25489004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022352s004lbl.pdf 5/7/2010
AP07/20/2011SLR29588013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022352s013s014ltr.pdf 7/25/2011
AP07/20/2011SLR29600013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022352s013s014lbl.pdf 7/25/2011
AP07/20/2011SLR29589014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022352s013s014ltr.pdf 7/25/2011
AP07/20/2011SLR29601014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022352s013s014lbl.pdf 7/25/2011
AP08/14/2014SLR40244017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022352Orig1s017ltr.pdf 8/15/2014
AP08/14/2014SLR40248017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022352s017lbl.pdf 8/15/2014
AP05/15/2013SCM       
AP011/25/2013SCM       
AP012/17/2015SLR44820022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022352Orig1s022ltr.pdf 12/18/2015
AP012/17/2015SLR44923022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022352s022lbl.pdf 12/31/2015
AP01/25/2016SCM       




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