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FDA Drug Application 050757 by TAKEDA PHARMS USA

Application Number050757
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
AP012/2/1997N4295000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/050757a.pdf 12/2/1997
AP01/9/1998SCS       
AP01/22/1999SE21074002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/50757s2ltr.pdf 1/22/1999
AP01/22/1999SE21075002   http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/50757s2lbl.pdf 1/22/1999
AP01/22/1999SE23888002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/50-757s002_Prevpac.cfm 1/22/1999
AP08/20/1999SCP3885003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/50-757S003_Prevpac_Approv.pdf 8/20/1999
AP08/20/1999SCP3886003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/50-757S003_Prevpac_prntlbl.pdf 8/20/1999
AP08/20/1999SCP3887003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/50-757s003_Prevpac.cfm 8/20/1999
AP010/22/1999SCP3882004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/50-757S004_Prevpac_Approv.pdf 10/22/1999
AP010/22/1999SCP3883004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/50-757S004_Prevpac_prntlbl.pdf 10/22/1999
AP010/22/1999SCP3884004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/50-757s004_Prevpac.cfm 10/22/1999
AP02/27/2001SCP       
AP011/22/2002SLR3880006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50757slr006,008ltr.pdf 11/22/2002
AP011/22/2002SLR3881006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50757slr006,008_prevpac_lbl.pdf 11/22/2002
AP03/12/2002SCS       
AP011/22/2002SLR9339008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50757slr006,008ltr.pdf 6/14/2004
AP011/22/2002SLR9340008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50757slr006,008_prevpac_lbl.pdf 6/14/2004
AP07/27/2004SLR9909009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50757s009,010ltr.pdf 7/30/2004
AP07/27/2004SLR9910010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50757s009,010ltr.pdf 7/30/2004
AP04/20/2005SLR11503011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050757s011ltr.pdf 4/28/2005
AP04/20/2005SLR11522011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050757s011lbl.pdf 4/28/2005
AP08/9/2006SLR14694012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050757s012, 050757s013LTR.pdf 8/14/2006
AP08/9/2006SLR14693013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050757s012, 050757s013LTR.pdf 8/14/2006
AP05/31/2007SLR16663014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050757s014ltr.pdf 6/4/2007
AP010/30/2007SLR18307015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050757s015lbl.pdf 11/7/2007
AP010/30/2007SLR18383015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050757s015ltr.pdf 11/8/2007
AP04/1/2009SLR22208016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050757s016ltr.pdf 4/3/2009
AP011/6/2013SLR37741017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050757s017lbl.pdf 11/8/2013
AP011/6/2013SLR37743017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050757Orig1s017ltr.pdf 11/8/2013
AP012/19/2014SLR41350019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050757s019lbl.pdf 12/22/2014
AP012/19/2014SLR41362019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050757Orig1s019ltr.pdf 12/23/2014
AP010/24/2016SLR47445020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050757Orig1s020ltr.pdf 10/26/2016
AP010/24/2016SLR47524020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050757s020lbl.pdf 10/31/2016




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