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FDA Drug Application 021925 by TAKEDA PHARMS USA

Application Number021925
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
AP07/28/2006N14595000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021925lbl.pdf 8/4/2006
AP07/28/2006N14602000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021925s000LTR.pdf 8/4/2006
AP07/28/2006N17624000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109136.htm 8/15/2007
AP07/28/2006N20742000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021925_duetact_toc.cfm 9/4/2008
AP07/28/2006N29677000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM227815.pdf 8/4/2011
AP02/6/2007SLR15817001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021925s001ltr.pdf 2/12/2007
AP02/6/2007SLR15904001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021925s001lbl.pdf 2/23/2007
AP09/6/2007SCP17782002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021925s002lbl.pdf 9/7/2007
AP09/6/2007SCP17848002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021925s002ltr.pdf 9/11/2007
AP010/1/2007SCF18124003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021925s003ltr.pdf 10/4/2007
AP010/1/2007SCF18163003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021925s003lbl.pdf 10/4/2007
AP09/26/2007SLR18149004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021925s004ltr.pdf 10/4/2007
AP09/26/2007SLR18043004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021925s004lbl.pdf 9/26/2007
AP01/4/2009SLR21533005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021925s005lbl.pdf 1/6/2009
AP01/4/2009SLR21549005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021925s005ltr.pdf 1/6/2009
AP011/12/2013SLR37809006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021925Orig1s006,s014ltr.pdf 11/14/2013
AP011/12/2013SLR37815006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021925s006s014lbl.pdf 11/14/2013
AP09/9/2009SLR23687007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021925s007ltr.pdf 10/26/2009
AP09/23/2010SLR26552008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021925s008ltr.pdf 9/28/2010
AP09/23/2010SLR26574008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021925s008lbl.pdf 9/29/2010
AP08/4/2011SLR29664010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021073Orig1s043s044-021842Orig1s014s015-022024Orig1s008s007-021925Orig1s010s011ltr.pdf 8/4/2011
AP08/4/2011SLR29672010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021925s010s011lbl.pdf 8/4/2011
AP08/4/2011SLR29673011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021925s010s011lbl.pdf 8/4/2011
AP08/4/2011SLR29665011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021073Orig1s043s044-021842Orig1s014s015-022024Orig1s008s007-021925Orig1s010s011ltr.pdf 8/4/2011
AP05/17/2012SLR32739012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021073s045,021842s016,022024s009,021925s012ltr.pdf 5/22/2012
AP07/22/2013SCM       
AP011/12/2013SLR37810014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021925Orig1s006,s014ltr.pdf 11/14/2013
AP011/12/2013SLR37814014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021925s006s014lbl.pdf 11/14/2013
AP03/16/2015SLR42167015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021925Orig1s015ltr.pdf 3/17/2015
AP03/16/2015SLR42197015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021925s015lbl.pdf 3/19/2015




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