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FDA Drug Application 022024 by TAKEDA PHARMS USA

Application Number022024
Application Type New Drug Application
Sponsor ApplicantTAKEDA PHARMS USA
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP05/12/2009N22575000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022024s000ltr.pdf 5/14/2009
AP05/12/2009N22888000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022024s000lbl.pdf 7/8/2009
AP05/12/2009N23815000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109136.htm 11/12/2009
AP05/12/2009N23879000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM170914.pdf 11/16/2009
AP05/12/2009N25108000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022024_actoplus_met_xr_toc.cfm 3/25/2010
AP011/12/2013SLR37811001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022024Orig1s001ltr.pdf 11/14/2013
AP011/12/2013SLR37816001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022024s001lbl.pdf 11/14/2013
AP012/22/2010SLR27375002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022024s002lbl.pdf 12/26/2010
AP012/22/2010SLR27402002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022024s002ltr.pdf 12/28/2010
AP08/4/2011SLR29666007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021073Orig1s043s044-021842Orig1s014s015-022024Orig1s008s007-021925Orig1s010s011ltr.pdf 8/4/2011
AP08/4/2011SLR29674007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022024s007s008lbl.pdf 8/4/2011
AP08/4/2011SLR29675008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022024s007s008lbl.pdf 8/4/2011
AP08/4/2011SLR29667008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021073Orig1s043s044-021842Orig1s014s015-022024Orig1s008s007-021925Orig1s010s011ltr.pdf 8/4/2011
AP05/17/2012SLR32738009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021073s045,021842s016,022024s009,021925s012ltr.pdf 5/22/2012
AP09/27/2013SCM       
AP03/16/2015SCM       




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