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FDA Drug Application 021518 by ASTELLAS

Application Number021518
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
AP011/19/2004N10668000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21518ltr.pdf 12/2/2004
AP011/19/2004N10720000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21518lbl.pdf 12/3/2004
AP011/19/2004N11095000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-518_VesiCare.cfm 2/8/2005
AP07/12/2007SLR17289003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021518s003lbl.pdf 7/16/2007
AP07/12/2007SLR17334003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021518s003ltr.pdf 7/24/2007
AP02/8/2008SLR19089004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021518s004ltr.pdf 2/14/2008
AP02/8/2008SLR19110004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021518s004lbl.pdf 2/14/2008
AP010/29/2008SLR21111006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021518s006ltr.pdf 10/30/2008
AP011/18/2008SLR21247007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021518s007lbl.pdf 11/19/2008
AP011/18/2008SLR21257007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021518s007ltr.pdf 11/21/2008
AP07/12/2010SLR25960008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021518s008lbl.pdf 7/1/2010
AP07/12/2010SLR25963008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021518s008ltr.pdf 7/14/2010
AP03/10/2011SLR28222010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021518s010lbl.pdf 3/11/2011
AP03/10/2011SLR28235010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021518s010ltr.pdf 3/14/2011
AP06/7/2012SLR32868011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021518s011lbl.pdf 6/11/2012
AP06/7/2012SLR32895011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021518s011ltr.pdf 6/12/2012
AP01/17/2012SLR31413012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021518s012ltr.pdf 1/19/2012
AP01/17/2012SLR31472012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021518s012lbl.pdf 1/23/2012
AP07/13/2012SLR33204013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021518Orig1s013ltr.pdf 7/17/2012
AP07/13/2012SLR33278013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021518S013lbl.pdf 7/25/2012
AP08/3/2012SLR33372014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021518Orig1s014ltr.pdf 8/6/2012
AP08/3/2012SLR33397014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021518s014lbl.pdf 8/6/2012
AP03/29/2013SLR35586015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021518Orig1s015ltr.pdf 4/1/2013
AP03/29/2013SLR35624015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021518s015lbl.pdf 4/1/2013
AP010/9/2013SLR37405016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021518Orig1s016ltr.pdf 10/11/2013
AP010/9/2013SLR37446016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021518s016lbl.pdf 10/17/2013




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