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FDA Drug Application 022000 by SHIRE

Application Number022000
Application Type New Drug Application
Sponsor ApplicantSHIRE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP01/16/2007N15684000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022000lbl.pdf 1/18/2007
AP01/16/2007N15712000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022000s000ltr.pdf 1/25/2007
AP01/16/2007N17733000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022000s000TOC.cfm 8/31/2007
AP010/30/2009SLR24231002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022000s002lbl.pdf 12/10/2009
AP09/22/2010SLR26536003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022000s003lbl.pdf 9/23/2010
AP09/22/2010SLR26544003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022000s003ltr.pdf 9/27/2010
AP07/14/2011SE829522005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022000s005ltr.pdf 7/18/2011
AP07/14/2011SE829525005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022000s005lbl.pdf 7/18/2011
AP07/14/2011SE842056005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022000Orig1s005.pdf 3/9/2015
AP08/9/2013SLR36771008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022000Orig1s008,022000Orig1s010ltr.pdf 8/12/2013
AP08/9/2013SLR36775008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022000s008s010lbl.pdf 8/12/2013
AP08/28/2013SLR36920009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022000Orig1s009ltr.pdf 8/29/2013
AP08/28/2013SLR37217009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022000Orig1s009lbl.pdf 9/24/2013
AP08/9/2013SLR36770010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022000Orig1s008,022000Orig1s010ltr.pdf 8/12/2013
AP08/9/2013SLR36776010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022000s008s010lbl.pdf 8/12/2013
AP012/16/2013SLR38073011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022000Orig1s011ltr.pdf 12/17/2013
AP012/16/2013SLR38079011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022000s011lbl.pdf 12/17/2013
AP03/14/2014SLR       
AP010/16/2014SLR40835013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022000Orig1s013ltr.pdf 10/21/2014
AP010/16/2014SLR40851013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022000s013lbl.pdf 10/21/2014




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