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FDA Drug Application 022287 by TAKEDA PHARMS USA

Application Number022287
Application Type New Drug Application
Sponsor ApplicantTAKEDA PHARMS USA
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New ester, new salt, or other noncovalent derivative
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP01/30/2009N21742000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022287s000ltr.pdf 2/4/2009
AP01/30/2009N22827000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022287s000TOC.cfm 6/24/2009
AP01/30/2009N22828000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022287s000_SumR.pdf 6/24/2009
AP01/30/2009N31055000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm213259.htm 12/20/2011
AP01/30/2009N33912000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM322208.pdf 10/2/2012
AP06/22/2010SLR25805002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022287s002lbl.pdf 6/24/2010
AP06/22/2010SLR25822002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022287s002ltr.pdf 6/24/2010
AP03/19/2010SLR25100003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022287s003ltr.pdf 3/25/2010
AP03/19/2010SLR25114003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022287s003lbl.pdf 3/26/2010
AP03/19/2010SLR25098004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022287s004ltr.pdf 3/25/2010
AP03/19/2010SLR25113004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022287s004lbl.pdf 3/26/2010
AP09/3/2010SLR26427005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022287s005ltr.pdf 9/8/2010
AP09/3/2010SLR26459005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022287s005lbl.pdf 9/10/2010
AP04/7/2011SLR28509007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022287s007lbl.pdf 4/11/2011
AP04/7/2011SLR28510007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022287s007ltr.pdf 4/11/2011
AP06/17/2011SE129290008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022287s008lbl.pdf 6/27/2011
AP06/17/2011SE129295008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022287Orig1s008ltr_replace.pdf 6/28/2011
AP010/28/2011SLR30440011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022287s011ltr.pdf 10/31/2011
AP010/28/2011SLR30446011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022287s011lbl.pdf 11/1/2011
AP05/20/2011SLR28933012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022287s012ltr.pdf 5/25/2011
AP05/20/2011SLR28970012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022287s012lbl.pdf 5/26/2011
AP09/28/2012SLR33887014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022287s014lbl.pdf 10/1/2012
AP09/28/2012SLR33919014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022287Orig1s014ltr.pdf 10/2/2012
AP05/3/2012SLR32635015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022287s015lbl.pdf 5/7/2012
AP05/3/2012SLR32664015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022287Orig1s015ltr.pdf 5/9/2012
AP012/20/2012SCM       
AP08/20/2013SLR36849017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022287s017lbl.pdf 8/21/2013
AP08/20/2013SLR36876017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022287Orig1s017ltr.pdf 8/22/2013
AP012/16/2015SLR44808018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022287s018lbl.pdf 12/17/2015
AP012/16/2015SLR44825018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022287Orig1s018ltr.pdf 12/18/2015
AP012/19/2014SLR41367019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022287Orig1s019ltr.pdf 12/23/2014
AP012/19/2014SLR41426019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022287s019lbl.pdf 12/29/2014
AP02/2/2016SLR45119020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022287Orig1s020ltr.pdf 2/4/2016
AP02/2/2016SLR45157020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022287s020lbledt.pdf 2/11/2016
AP07/8/2016SE846501021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022287Orig1s021,022287Orig1s022,022287Orig1s023,208056Orig1s001ltr.pdf 7/12/2016
AP07/8/2016SE846570021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022287s021s022s023,208056s001lbl.pdf 7/20/2016
AP07/8/2016SE846502022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022287Orig1s021,s022,s023,208056Orig1s001ltr.pdf 7/12/2016
AP07/8/2016SE846571022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022287s021s022s023,208056s001lbl.pdf 7/20/2016
AP07/8/2016SE846503023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022287Orig1s021,s022,s023,208056Orig1s001ltr.pdf 7/12/2016
AP07/8/2016SE846572023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022287s021s022s023,208056s001lbl.pdf 7/20/2016
AP09/29/2016SCM       
AP010/24/2016SLR47467026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022287Orig1s026,208056Orig1s003ltr.pdf 10/26/2016
AP010/24/2016SLR47515026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022287s026,208056s003lbl.pdf 10/28/2016




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