Back to FDA Applications sponsored by TAKEDA PHARMS USA

FDA Drug Application 021073 by TAKEDA PHARMS USA

Application Number021073
Application Type New Drug Application
Sponsor ApplicantTAKEDA PHARMS USA
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP07/15/1999N1112000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21073ltr.pdf 7/15/1999
AP07/15/1999N1113000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/021073A_Actos.cfm 6/30/2000
AP07/15/1999N1114000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21073lbl.pdf 7/15/1999
AP07/15/1999N23453000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM183833.pdf 9/25/2009
AP02/25/2000SCP17876001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/021073_S001_ACTOS.pdf 9/13/2007
AP02/25/2000SCS17877002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/021073_S002_ACTOS.pdf 9/13/2007
AP04/11/2000SCM17878003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/021073_S003_ACTOS.pdf 9/13/2007
AP010/25/2000SCS19217004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/021073_S004_ACTOS.pdf 2/19/2008
AP07/26/2000SCM17879005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/021073_S005_ACTOS.pdf 9/13/2007
AP011/3/2000SCM19216006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/021073_S006_ACTOS.pdf 2/19/2008
AP04/25/2001SCM19215007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021073_S007_ACTOS.pdf 2/19/2008
AP07/6/2001SCM17402008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021073_S008_ACTOS TABLETS.pdf 7/27/2007
AP07/6/2001SCM       
AP07/12/2002SE82456010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21073se8010ltr.pdf 7/12/2002
AP07/12/2002SE82457010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21073s10lbl.pdf 7/12/2002
AP07/12/2002SE817203010   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021073_S010_Actos Tablets_APPROVAL PACKAGE.pdf 7/9/2007
AP07/2/2001SLR       
AP05/22/2001SCM17401012   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021073_S012_ACTOS TABLETS.pdf 7/27/2007
AP010/1/2002SCS19225013   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021073_S013_ACTOS_TABLETS.pdf 2/19/2008
AP08/3/2001SCM18509014   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021073_S014_ACTOS.pdf 11/19/2007
AP02/28/2002SCS19226015   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021073_S015_ACTOS_TABLETS.pdf 2/19/2008
AP01/7/2002SLR2454016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21073s16ltr.pdf 1/7/2002
AP01/7/2002SLR18508016   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021073_S016_ACTOS.pdf 11/19/2007
AP01/21/2003SE84707017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21073se8-017ltr.pdf 1/17/2003
AP012/3/2002SCP2455018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21073scp018ltr.pdf 12/3/2002
AP011/26/2003SE87051020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21073se8-020ltr.pdf 12/4/2003
AP011/26/2003SE87067020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21073se8-020_actos_lbl.pdf 12/8/2003
AP011/26/2003SE817041020   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021073_S020_ACTOS TABLETS_AP.pdf 7/6/2007
AP06/11/2003SLR5972021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21073slr071ltr.pdf 6/22/2003
AP06/11/2003SLR5988021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21073slr071_actos_lbl.pdf 6/22/2003
AP08/3/2004SLR9939023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21073s023ltr.pdf 8/5/2004
AP08/3/2004SLR9944023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21073s023lbl.pdf 8/5/2004
AP08/3/2004SLR20363023   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021073_s023_ACTOS TABS.pdf 7/31/2008
AP07/20/2004SLR9832024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21073s024ltr.pdf 7/21/2004
AP07/20/2004SLR9839024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21073s024lbl.pdf 7/21/2004
AP07/20/2004SLR20362024   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021073_s024_ACTOS TABS.pdf 7/31/2008
AP02/25/2007SE815955026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021073s026ltr.pdf 3/6/2007
AP02/25/2007SE816003026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021073s026lbl.pdf 3/7/2007
AP08/30/2006SLR14777027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021073s027lbl.pdf 9/1/2006
AP08/30/2006SLR14857027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021073s027ltr.pdf 9/18/2006
AP011/4/2006SLR15290028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021073s028,021842s002lbl.pdf 11/6/2006
AP011/4/2006SLR15326028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021073S028, 021842S002ltr.pdf 11/7/2006
AP09/28/2006SLR15037029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021073s029, 021842s003LTR.pdf 10/2/2006
AP09/6/2007SLR17828030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021073s030lbl.pdf 9/11/2007
AP09/6/2007SLR17864030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021073s030_ltr.pdf 9/11/2007
AP08/14/2007SLR17625031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021073s031lbl.pdf 8/15/2007
AP08/14/2007SLR17653031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021073s031LTR.pdf 8/17/2007
AP05/7/2008SLR19796033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021073s033ltr.pdf 5/9/2008
AP05/7/2008SLR19993033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021073s033PI.pdf 6/12/2008
AP012/11/2008SLR21360034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021073s034ltr.pdf 12/18/2008
AP012/11/2008SLR21484034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021073s034lbl.pdf 1/2/2009
AP02/3/2011SLR27782035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021073s035lbl.pdf 2/9/2011
AP09/9/2009SLR23400037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021073s037lbl.pdf 9/18/2009
AP09/9/2009SLR23683037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021073s037ltr.pdf 10/26/2009
AP07/29/2010SLR26044040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021073s040ltr.pdf 7/30/2010
AP08/4/2011SLR29679043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021073s043s044lbl.pdf 8/4/2011
AP08/4/2011SLR29684043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021073Orig1s043s044-021842Orig1s014s015-022024Orig1s008s007-021925Orig1s010s011ltr.pdf 8/5/2011
AP08/4/2011SLR29669044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021073s043s044lbl.pdf 8/4/2011
AP08/4/2011SLR29683044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021073Orig1s043s044-021842Orig1s014s015-022024Orig1s008s007-021925Orig1s010s011ltr.pdf 8/5/2011
AP05/17/2012SLR32736045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021073s045,021842s016,022024s009,021925s012ltr.pdf 5/22/2012
AP011/12/2013SLR37808046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021073Orig1s046ltr.pdf 11/14/2013
AP011/12/2013SLR37813046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021073s046lbl.pdf 11/14/2013
AP06/27/2013SCM       




Back to FDA Applications sponsored by TAKEDA PHARMS USA