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FDA Drug Application 022362 by DAIICHI SANKYO

Application Number022362
Application Type New Drug Application
Sponsor ApplicantDAIICHI SANKYO
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/2/2009N23551000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022362lbl.pdf 10/7/2009
AP010/2/2009N23675000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021176s022_022362s000ltr.pdf 10/26/2009
AP010/2/2009N25155000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022362_welchol_toc.cfm 3/31/2010
AP010/2/2009N25156000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022362s000sumr.pdf 3/31/2010
AP09/14/2010SLR26492002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021176s027,022362s002ltr.pdf 9/16/2010
AP09/14/2010SLR26511002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021176s027,022362s002lbl.pdf 9/20/2010
AP07/18/2011SLR29541007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022362s007lbl.pdf 7/18/2011
AP07/18/2011SLR29543007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022362s007,021176s028ltr.pdf 7/19/2011
AP01/3/2012SLR31359009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021176s029,022362s009lbl.pdf 1/6/2012
AP01/3/2012SLR31397009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021176s029,022362s009ltr.pdf 1/17/2012
AP07/9/2012SLR33170010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021176Orig1s030,022362Orig1s010ltr.pdf 7/13/2012
AP07/9/2012SLR33177010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021176s030,022362s010lbl.pdf 7/13/2012
AP011/15/2012SCM       
AP02/15/2013SCM       
AP02/27/2013SCM       
AP06/28/2013SCM36426015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021176Orig1s034,s038,022362Orig1s015,s017,s018ltr_replace.pdf 7/2/2013
AP06/28/2013SCM36419015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021176s034s038,022362s015s017s018lbl.pdf 7/2/2013
AP03/7/2013SCM       
AP06/28/2013SLR36427017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021176Orig1s034,s038,022362Orig1s015,s017,s018ltr_replace.pdf 7/2/2013
AP06/28/2013SLR36420017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021176s034s038,022362s015s017s018lbl.pdf 7/2/2013
AP06/28/2013SLR36421018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021176s034s038,022362s015s017s018lbl.pdf 7/2/2013
AP06/28/2013SLR36428018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021176Orig1s034,s038,022362Orig1s015,s017,s018ltr_replace.pdf 7/2/2013
AP03/11/2014SCM       
AP01/22/2014SLR38354020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021176Orig1s037,022362Orig1s020ltr.pdf 1/23/2014
AP01/22/2014SLR38360020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021176s037,022362s020lbl.pdf 1/23/2014




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