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FDA Drug Application 021842 by TAKEDA PHARMS USA

Application Number021842
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
AP08/29/2005N12664000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021842lbl.pdf 8/30/2005
AP08/29/2005N12665000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021842ppi.pdf 8/30/2005
AP08/29/2005N12669000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021842ltr.pdf 8/31/2005
AP08/29/2005N15691000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021842s000TOC.cfm 1/22/2007
AP08/29/2005N23708000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM188473.pdf 10/30/2009
AP08/29/2005N23816000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109136.htm 11/12/2009
AP08/30/2006SLR14778001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021842s001lbl.pdf 9/1/2006
AP08/30/2006SLR14854001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021842s001ltr.pdf 9/18/2006
AP011/4/2006SLR15291002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021073s028,021842s002lbl.pdf 11/6/2006
AP011/4/2006SLR15325002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021073S028, 021842S002ltr.pdf 11/7/2006
AP09/28/2006SLR15036003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021073s029, 021842s003LTR.pdf 10/2/2006
AP09/26/2007SLR18042005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021842s005lbl.pdf 9/26/2007
AP09/26/2007SLR18152005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021842s005ltr.pdf 10/4/2007
AP01/4/2009SLR21532007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021842s007lbl.pdf 1/6/2009
AP01/4/2009SLR21548007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021842s007ltr.pdf 1/6/2009
AP05/17/2012SLR32710008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021842s008,021842s010ltr.pdf 5/18/2012
AP05/17/2012SLR32732008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021842s008s010lbl.pdf 5/22/2012
AP05/17/2012SLR32734008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021842s008s010mg.pdf 5/22/2012
AP09/14/2009SLR23686009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021842s009ltr.pdf 10/26/2009
AP05/17/2012SE832711010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021842s008,021842s010ltr.pdf 5/18/2012
AP05/17/2012SE832733010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021842s008s010lbl.pdf 5/22/2012
AP010/21/2009S23671011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021842s011lbl.pdf 10/23/2009
AP010/21/2009S24147011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021842s011ltr.pdf 11/25/2009
AP08/6/2010SLR26200012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021842s012ltr.pdf 8/11/2010
AP08/4/2011SLR29662014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021073Orig1s043s044-021842Orig1s014s015-022024Orig1s008s007-021925Orig1s010s011ltr.pdf 8/4/2011
AP08/4/2011SLR29670014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021842s014s015lbl.pdf 8/4/2011
AP08/4/2011SLR29663015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021073Orig1s043s044-021842Orig1s014s015-022024Orig1s008s007-021925Orig1s010s011ltr.pdf 8/4/2011
AP08/4/2011SLR29671015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021842s014s015lbl.pdf 8/4/2011
AP05/17/2012SLR32737016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021073s045,021842s016,022024s009,021925s012ltr.pdf 5/22/2012
AP08/15/2013SCM       
AP08/16/2014SLR40258019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021842Orig1s019ltr.pdf 8/19/2014
AP08/16/2014SLR40289019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021842s019lbl.pdf 8/20/2014




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