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FDA Drug Application 021532 by DAIICHI SANKYO

Application Number021532
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
AP06/5/2003N5866000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21532ltr.pdf 6/8/2003
AP06/5/2003N5894000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21532_benicar_lbl.pdf 6/8/2003
AP06/5/2003N6627000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021532_benicar_toc.cfm 9/10/2003
AP011/15/2004SLR10596001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21532s001ltr.pdf 11/16/2004
AP07/13/2005SLR11991004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021532s004lbl.pdf 7/15/2005
AP07/13/2005SLR12005004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021532s004ltr.pdf 7/15/2005
AP011/16/2007SLR18472008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021532s008ltr.pdf 11/19/2007
AP05/3/2011SLR28710013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021532s013s014lbl.pdf 5/5/2011
AP05/3/2011SLR28716013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021532s013,s014ltr.pdf 5/5/2011
AP05/3/2011SLR28711014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021532s013s014lbl.pdf 5/5/2011
AP05/3/2011SLR28717014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021532s013,s014ltr.pdf 5/5/2011
AP02/11/2016SLR45162015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021532Orig1s015ltr.pdf 2/12/2016
AP02/11/2016SLR45190015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021532s015lbl.pdf 2/18/2016
AP01/18/2012SLR31422016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021532s016ltr.pdf 1/20/2012
AP01/18/2012SLR31589016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021532s016lbl.pdf 1/30/2012
AP02/1/2013SCM       
AP09/18/2012SLR33808020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021532s020lbl.pdf 9/20/2012
AP09/18/2012SLR33821020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021532Orig1s020ltr.pdf 9/24/2012
AP012/10/2012SLR34596021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021532Orig1s021ltr_r.pdf 12/11/2012
AP012/10/2012SLR34662021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021532s021lbl.pdf 12/14/2012
AP07/3/2013SLR36449022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021532Orig1s022ltr.pdf 7/5/2013
AP07/3/2013SLR36461022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021532s022lbl.pdf 7/5/2013
AP05/7/2014SCM       
AP06/13/2014SLR39552024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021532Orig1s024ltr.pdf 6/17/2014
AP06/13/2014SLR39559024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021532s024lbl.pdf 6/17/2014
AP06/27/2014SLR39698025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021532Orig1s025ltr.pdf 6/30/2014
AP06/27/2014SLR39704025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021532s025lbl.pdf 6/30/2014
AP09/23/2014SLR40595026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021532Orig1s026ltr.pdf 9/24/2014
AP09/23/2014SLR40623026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021532s026lbl.pdf 9/26/2014
AP05/13/2016SCM       
AP09/20/2016SCM       




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