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FDA Drug Application 021506 by ASTELLAS

Application Number021506
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 Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/16/2005N11256000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21506,21754ltr.pdf 3/18/2005
AP03/16/2005N11272000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21506,21754lbl.pdf 3/18/2005
AP03/16/2005N11275000Package Label  http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21506,21754lbl_2.pdf 3/18/2005
AP03/16/2005N12660000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/21-506_Mycamine.cfm 8/24/2005
AP06/27/2006SCF14386004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021506s004lbl.pdf 6/28/2006
AP06/27/2006SCF14406004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021506s004ltr.pdf 7/3/2006
AP01/22/2008SE118941008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021506s008ltr.pdf 1/24/2008
AP01/22/2008SE118949008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021506s008lbl.pdf 1/24/2008
AP08/6/2007SLR17546009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021506s009lbl.pdf 8/7/2007
AP08/6/2007SLR17563009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021506s009ltr.pdf 8/7/2007
AP06/8/2011SLR29271011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021506s011s012lbl.pdf 6/27/2011
AP06/8/2011SLR29105011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021506s011,s012ltr.pdf 6/10/2011
AP06/8/2011SLR29107012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021506s011,s012ltr.pdf 6/10/2011
AP06/8/2011SLR29272012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021506s011s012lbl.pdf 6/27/2011
AP04/19/2013SLR35793014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021506s014lbl.pdf 4/23/2013
AP04/19/2013SLR35815014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021506Orig1s014ltr.pdf 4/24/2013
AP06/21/2013S36371015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021506Orig1s015ltr.pdf 6/24/2013
AP06/21/2013S36379015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021506s015lbl.pdf 6/25/2013
AP08/27/2015SCM       
AP06/6/2016SCM       
AP010/14/2016SCM       
AP08/26/2016SLR46914019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021506s019lbl.pdf 8/29/2016
AP08/26/2016SLR46928019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021506Orig1s019ltr.pdf 8/30/2016




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