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FDA Drug Application 021286 by DAIICHI SANKYO

Application Number021286
Application Type New Drug Application
Sponsor ApplicantDAIICHI SANKYO
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP04/25/2002N4426000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21286.pdf 4/25/2002
AP04/25/2002N4427000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21286lbl.pdf 4/25/2002
AP04/25/2002N4428000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-286_Benicar.cfm 7/5/2002
AP010/25/2002SLR4429001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21286slr001ltr.pdf 10/25/2002
AP02/12/2003SLR4430002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21286slr002ltr.pdf 2/12/2003
AP011/15/2004SLR10595006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21286s006ltr.pdf 11/16/2004
AP07/13/2005SLR11990010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021286s010lbl.pdf 7/15/2005
AP07/13/2005SLR12002010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021286s010ltr.pdf 7/15/2005
AP07/13/2005SLR43426010   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021286Orig1s010.pdf 7/21/2015
AP09/26/2007SLR18137012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021286s012ltr.pdf 10/4/2007
AP02/4/2010SE524763018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021286s018lbl.pdf 2/16/2010
AP02/4/2010SE524793018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021286s018ltr.pdf 2/17/2010
AP05/19/2011SLR28889019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021286s019lbl.pdf 5/23/2011
AP05/19/2011SLR28912019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021286s019ltr.pdf 5/24/2011
AP06/6/2011SLR29043020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021286s020lbl.pdf 6/6/2011
AP06/6/2011SLR29051020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021286s020ltr.pdf 6/7/2011
AP02/15/2012SLR31806021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021286s021ltr.pdf 2/17/2012
AP02/15/2012SLR31821021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021286s021lbl.pdf 2/17/2012
AP03/29/2012SLR32308023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021286s023lbl.pdf 3/30/2012
AP03/29/2012SLR32323023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021286s023ltr.pdf 4/2/2012
AP02/1/2013SCM       
AP09/28/2012SLR33928025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021286s025lbl.pdf 10/2/2012
AP09/28/2012SLR33946025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021286Orig1s025ltr.pdf 10/3/2012
AP012/10/2012SLR34597026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021286Orig1s026ltr_r.pdf 12/11/2012
AP012/10/2012SLR34633026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021286s026lbl.pdf 12/13/2012
AP07/3/2013SLR36448027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021286Orig1s027ltr.pdf 7/5/2013
AP07/3/2013SLR36460027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021286s027lbl.pdf 7/5/2013
AP010/7/2014SCM       
AP07/3/2014SCM       
AP06/13/2014SLR39550030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021286Orig1s030ltr.pdf 6/17/2014
AP06/13/2014SLR39558030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021286s030lbl.pdf 6/17/2014
AP06/27/2014SLR39697031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021286Orig1s031ltr.pdf 6/30/2014
AP06/27/2014SLR39703031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021286s031lbl.pdf 6/30/2014
AP09/23/2014SLR40596032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021286Orig1s032ltr.pdf 9/24/2014
AP09/23/2014SLR40624032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021286s032lbl.pdf 9/26/2014
AP06/10/2016SCM       
AP07/8/2016SCM       




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