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FDA Drug Application 022106 by SHIONOGI INC

Application Number022106
Application Type New Drug Application
Sponsor ApplicantSHIONOGI INC
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
AP010/12/2007N18240000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022106lbl.pdf 10/15/2007
AP010/12/2007N18284000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022106s000ltr.pdf 10/22/2007
AP010/12/2007N19459000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022106TOC.cfm 3/14/2008
AP010/12/2007N20262000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022106s000_SumR.pdf 7/22/2008
AP04/16/2009SLR22297002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022106s002,022106s005ltr.pdf 4/21/2009
AP04/16/2009SLR22316002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022106s002s005lbl.pdf 4/23/2009
AP02/11/2009SLR21812003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022106s003lbl.pdf 2/12/2009
AP04/16/2009SLR22298005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022106s002,022106s005ltr.pdf 4/21/2009
AP04/16/2009SLR22317005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022106s002s005lbl.pdf 4/23/2009
AP04/15/2013SLR35687007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022106s007lbl.pdf 4/15/2013
AP04/15/2013SLR35711007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022106Orig1s007,s008,s009,s014ltr.pdf 4/16/2013
AP04/15/2013SLR35689008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022106s008lbl.pdf 4/15/2013
AP04/15/2013SLR35712008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022106Orig1s007,s008,s009,s014ltr.pdf 4/16/2013
AP04/15/2013SLR35690009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022106s009lbl.pdf 4/15/2013
AP04/15/2013SLR35713009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022106Orig1s007,s008,s009,s014ltr.pdf 4/16/2013
AP01/26/2012SLR31612011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022106s011lbl.pdf 1/31/2012
AP01/17/2014SLR38334012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022106Orig1s012ltr.pdf 1/21/2014
AP01/17/2014SLR38345012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022106s012lbl.pdf 1/22/2014
AP04/15/2013SLR35691014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022106s014lbl.pdf 4/15/2013
AP04/15/2013SLR35714014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022106Orig1s007,s008,s009,s014ltr.pdf 4/16/2013
AP08/10/2015SLR43617015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022106Orig1s015ltr.pdf 8/11/2015
AP08/10/2015SLR43626015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022106s015lbl.pdf 8/11/2015
AP011/13/2015SCM       




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