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FDA Drug Application 022100 by DAIICHI SANKYO

Application Number022100
Application Type New Drug Application
Sponsor ApplicantDAIICHI SANKYO
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
AP09/26/2007N18135000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022100s000ltr.pdf 10/4/2007
AP09/26/2007N18171000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022100lbl.pdf 10/4/2007
AP09/26/2007N24298000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022100_azor_toc.cfm 12/17/2009
AP05/11/2009SE122556002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022100s002lbl.pdf 5/13/2009
AP05/11/2009SE122574002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022100s002ltr.pdf 5/14/2009
AP08/7/2008SLR20584003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022100s003ltr.pdf 8/12/2008
AP05/19/2011SLR28910010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022100s010,s012ltr.pdf 5/24/2011
AP05/19/2011SLR28886010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022100s010s012lbl.pdf 5/23/2011
AP05/19/2011SLR28887012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022100s010s012lbl.pdf 5/23/2011
AP05/19/2011SLR28911012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022100s010,s012ltr.pdf 5/24/2011
AP011/14/2011SLR30579013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022100s013lbl.pdf 11/14/2011
AP011/14/2011SLR30593013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022100s013ltr.pdf 11/16/2011
AP011/2/2011SLR30476014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022100s014lbl.pdf 10/31/2011
AP011/2/2011SLR30488014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022100s014ltr.pdf 11/3/2011
AP01/18/2012SLR31423016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022100s016ltr.pdf 1/20/2012
AP01/18/2012SLR31454016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022100s016lbl.pdf 1/23/2012
AP02/1/2013SCM       
AP09/28/2012SLR33931019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022100s019lbl.pdf 10/2/2012
AP09/28/2012SLR33949019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022100Orig1s019ltr.pdf 10/3/2012
AP012/11/2012SLR34598020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022100Orig1s020ltr_r.pdf 12/11/2012
AP012/11/2012SLR34634020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022100s020lbl.pdf 12/13/2012
AP07/3/2013SLR36451022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022100Orig1s022ltr.pdf 7/5/2013
AP07/3/2013SLR36462022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022100s022lbl.pdf 7/5/2013
AP05/14/2014SCM       
AP06/13/2014SLR39560024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022100s024lbl.pdf 6/17/2014
AP06/13/2014SLR39574024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022100Orig1s024ltr.pdf 6/18/2014
AP07/2/2014SLR39746025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022100Orig1s025ltr.pdf 7/3/2014
AP07/2/2014SLR39757025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022100s025lbl.pdf 7/3/2014
AP09/23/2014SLR40594026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022100Orig1s026ltr.pdf 9/24/2014
AP09/23/2014SLR40622026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022100s026lbl.pdf 9/26/2014
AP07/9/2015SCM       
AP06/4/2015SCM       
AP07/8/2016SCM       
AP08/15/2016SCM       




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