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FDA Drug Application 022161 by ASTELLAS

Application Number022161
Application Type New Drug Application
Sponsor ApplicantASTELLAS
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
AP04/10/2008N19652000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022161s000ltr.pdf 4/16/2008
AP04/10/2008N19671000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022161lbl.pdf 4/16/2008
AP04/10/2008N19914000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022161s000_LexiscanTOC.cfm 6/2/2008
AP04/10/2008N38466000   http://www.fda.gov/drugs/drugsafety/ucm375654.htm 2/7/2014
AP03/17/2009SLR22048003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022161s003ltr.pdf 3/19/2009
AP03/17/2009SLR22193003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022161s003lbl.pdf 4/3/2009
AP012/23/2009SLR24375004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022161s004lbl.pdf 12/30/2009
AP012/23/2009SLR24385004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022161s004ltr.pdf 12/31/2009
AP03/29/2014SCM       
AP09/23/2011SLR30107006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022161s006,s007,s008ltr.pdf 9/28/2011
AP09/23/2011SLR30130006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022161s006s007s008lbl.pdf 9/29/2011
AP09/23/2011SLR30131007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022161s006s007s008lbl.pdf 9/29/2011
AP09/23/2011SLR30108007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022161s006,s007,s008ltr.pdf 9/28/2011
AP09/23/2011SLR30109008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022161s006,s007,s008ltr.pdf 9/28/2011
AP09/23/2011SLR30132008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022161s006s007s008lbl.pdf 9/29/2011
AP09/30/2011SLR30178009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022161s009lbl.pdf 9/30/2011
AP09/30/2011SLR30216009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022161s009ltr.pdf 10/4/2011
AP01/3/2014SLR38217011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022161Orig1s011ltr.pdf 1/7/2014
AP11/9/2014SLR38217011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022161Orig1s011ltr.pdf 1/7/2014
AP01/3/2014SLR38226011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022161s011lbl.pdf 1/7/2014
AP11/9/2014SLR38226011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022161s011lbl.pdf 1/7/2014
AP01/3/2014SLR38250011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022161s011lbledt.pdf 1/10/2014
AP11/9/2014SLR38250011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022161s011lbledt.pdf 1/10/2014
AP01/3/2014SLR38263011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022161Orig1s011ltr_corrected.pdf 1/14/2014
AP11/9/2014SLR38263011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022161Orig1s011ltr_corrected.pdf 1/14/2014
AP09/19/2014SLR40546012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022161s012lbl.pdf 9/22/2014
AP09/19/2014SLR40573012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022161Orig1s012ltr.pdf 9/23/2014




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