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FDA Drug Application 021468 by SHIRE LLC

Application Number021468
Application Type New Drug Application
Sponsor ApplicantSHIRE LLC
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
AP010/26/2004N10498000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21468ltr.pdf 10/29/2004
AP010/26/2004N10521000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21468lbl.pdf 11/1/2004
AP010/26/2004N11059000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-468_Fosrenol.cfm 1/28/2005
AP03/3/2006SLR27429004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021468_s004_fosrenol.pdf 1/4/2011
AP03/3/2006SLR27430005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021468_s005_fosrenol.pdf 1/4/2011
AP03/3/2006SLR13824005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021468s005ltr.pdf 3/23/2006
AP04/10/2008SLR19638010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021468s010ltr.pdf 4/11/2008
AP010/23/2008SLR21088011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021468s011ltr.pdf 10/28/2008
AP04/27/2011SLR28628014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021468s014,s015ltr.pdf 4/29/2011
AP04/27/2011SLR28651014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021468s014s015lbl.pdf 4/29/2011
AP04/27/2011SLR28652015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021468s014s015lbl.pdf 4/29/2011
AP04/27/2011SLR28629015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021468s014,s015ltr.pdf 4/29/2011
AP09/2/2011SLR29957016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021468s016lbl.pdf 9/7/2011
AP09/2/2011SLR29958016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021468s016MedG.pdf 9/7/2011
AP09/2/2011SLR29960016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021468s016ltr.pdf 9/7/2011
AP010/31/2012SLR34224018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021468s018lbl.pdf 11/2/2012
AP010/31/2012SLR34225018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021468s018mg.pdf 11/2/2012
AP010/31/2012SLR34259018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021468Orig1s018ltr.pdf 11/5/2012
AP09/24/2014SLR40612019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021468Orig1s019ltr.pdf 9/26/2014
AP09/24/2014SLR40631019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021468s019lbl.pdf 9/26/2014
AP02/24/2016SLR45282020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021468Orig1s020,204734Orig1s001ltr.pdf 2/26/2016
AP02/24/2016SLR45288020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021468s020,204734s001lbl.pdf 2/26/2016




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