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FDA Drug Application 022029 by HISAMITSU PHARM CO

Application Number022029
Application Type New Drug Application
Sponsor ApplicantHISAMITSU PHARM CO
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation; New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP02/20/2008N19303000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022029s000ltr.pdf 2/26/2008
AP02/20/2008N25407000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022029TOC.cfm 5/3/2010
AP02/20/2008N25408000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022029s000sumr.pdf 5/3/2010
AP08/25/2008SCP20664002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022029s002ltr.pdf 8/25/2008
AP06/19/2009SLR22816003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022029s003ltr.pdf 6/24/2009
AP06/19/2009SLR22843003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022029s003lbl.pdf 6/29/2009
AP09/13/2010SCM26483007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022029s007ltr.pdf 9/15/2010
AP06/6/2011SLR29055009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022029s009ltr.pdf 6/7/2011
AP03/30/2015SCM       
AP011/3/2012SE838278011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022029Orig1s011lbl.pdf 1/15/2014
AP011/3/2012SE834326011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022029Orig1s011ltr.pdf 11/7/2012
AP03/29/2013SE835587012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022029Orig1s012ltr.pdf 4/1/2013
AP06/13/2013SCM       
AP01/31/2014SCM38442014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022029Orig1s014ltr.pdf 2/4/2014
AP01/31/2014SCM38528014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022029Orig1s014lbl.pdf 2/14/2014




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