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FDA Drug Application 021977 by SHIRE DEVELOPMENT

Application Number021977
Application Type New Drug Application
Sponsor ApplicantSHIRE DEVELOPMENT
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
AP02/23/2007N15911000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021977lbl.pdf 2/26/2007
AP02/23/2007N15918000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089823.pdf 2/26/2007
AP02/23/2007N15962000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021977s000ltr.pdf 3/6/2007
AP02/23/2007N16159000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021977s000TOC.cfm 4/5/2007
AP02/23/2007N31036000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm283449.htm 12/20/2011
AP04/23/2008SE519722001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021977s001ltr.pdf 4/25/2008
AP04/23/2008SE519951001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021977s001lbl.pdf 6/5/2008
AP012/10/2007SCM18660002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021977s002lbl.pdf 12/14/2007
AP012/10/2007SCM18851002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021977s002.pdf 1/9/2008
AP05/22/2009SLR22610006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021977s006s007lbl.pdf 5/25/2009
AP05/22/2009SLR22655006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021977s006,s007ltr.pdf 5/29/2009
AP05/22/2009SE822656007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021977s006,s007ltr.pdf 5/29/2009
AP05/22/2009SE822609007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021977s006s007lbl.pdf 5/25/2009
AP011/12/2008SLR21225008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021303s019,021977s008ltr.pdf 11/13/2008
AP04/5/2010SE825221010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021977s010s015lbl.pdf 4/5/2010
AP04/5/2010SE825234010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021977s010,s015ltr.pdf 4/8/2010
AP03/16/2011SLR28272012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021977s012ltr.pdf 3/21/2011
AP03/16/2011SLR28297012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021977s012lbl.pdf 3/21/2011
AP012/2/2009SLR24277013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021977s013lbl.pdf 12/11/2009
AP012/2/2009SLR24653013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021977s013ltr.pdf 1/28/2010
AP04/5/2010SLR25235015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021977s010,s015ltr.pdf 4/8/2010
AP04/5/2010SLR25222015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021977s010s015lbl.pdf 4/5/2010
AP011/10/2010SE526938016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021977s016s018s019s021lbl.pdf 11/12/2010
AP011/10/2010SE526953016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021977s016,s018,s019,s021ltr.pdf 11/15/2010
AP011/10/2010SLR26954018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021977s016,s018,s019,s021ltr.pdf 11/15/2010
AP011/10/2010SLR26939018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021977s016s018s019s021lbl.pdf 11/12/2010
AP011/10/2010SLR26940019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021977s016s018s019s021lbl.pdf 11/12/2010
AP011/10/2010SLR26955019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021977s016,s018,s019,s021ltr.pdf 11/15/2010
AP04/15/2016SCM       
AP011/10/2010SLR26956021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021977s016,s018,s019,s021ltr.pdf 11/15/2010
AP011/10/2010SLR26941021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021977s016s018s019s021lbl.pdf 11/12/2010
AP01/31/2012SE531628022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021977s022lbl.pdf 2/1/2012
AP01/31/2012SE531644022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021977s022ltr.pdf 2/3/2012
AP09/1/2011S29940023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021977s023lbl.pdf 9/2/2011
AP09/1/2011S29949023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021977s023ltr.pdf 9/6/2011
AP011/19/2012SLR34466024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021977s024s025s026lbl.pdf 11/26/2012
AP011/19/2012SLR34438024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021977Orig1s024,s025,s026ltr.pdf 11/21/2012
AP011/19/2012SLR34463024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021977s024s025s026mg.pdf 11/26/2012
AP011/19/2012SLR34464025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021977s024s025s026mg.pdf 11/26/2012
AP011/19/2012SLR34439025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021977Orig1s024,s025,s026ltr.pdf 11/21/2012
AP011/19/2012SLR34467025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021977s024s025s026lbl.pdf 11/26/2012
AP011/19/2012SLR34468026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021977s024s025s026lbl.pdf 11/26/2012
AP011/19/2012SLR34440026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021977Orig1s024,s025,s026ltr.pdf 11/21/2012
AP011/19/2012SLR34465026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021977s024s025s026mg.pdf 11/26/2012
AP04/26/2013SE135860027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021977s027lbledt.pdf 4/29/2013
AP04/26/2013SE135886027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021977Orig1s027ltr.pdf 4/30/2013
AP06/14/2013SLR36298028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021977s028lbl.pdf 6/18/2013
AP06/14/2013SLR36330028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021977Orig1s028ltr.pdf 6/18/2013
AP05/14/2014SCM       
AP012/6/2013SLR37991030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021977Orig1s030ltr.pdf 12/10/2013
AP012/6/2013SLR38015030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021977s030lbl.pdf 12/12/2013
AP07/18/2014SLR39933031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021977Orig1s031,s032ltr.pdf 7/23/2014
AP07/18/2014SLR40063031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021977s031s032lbl.pdf 7/30/2014
AP07/18/2014SLR40064032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021977s031s032lbl.pdf 7/30/2014
AP07/18/2014SLR39934032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021977Orig1s031,s032ltr.pdf 7/23/2014
AP011/14/2014SLR41003033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021977Orig1s033ltr.pdf 11/17/2014
AP011/14/2014SLR41043033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021977s033lbl.pdf 11/20/2014
AP010/30/2014SCM       
AP01/30/2015SLR41752036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021977Orig1s036,s037ltr.pdf 2/2/2015
AP01/30/2015SLR42827036   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/021977Orig1s036.pdf 5/14/2015
AP01/30/2015SLR41766036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021977s036s037lbledt.pdf 2/3/2015
AP01/30/2015SE841767037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021977s036s037lbledt.pdf 2/3/2015
AP01/30/2015SE842828037   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/021977Orig1s037.pdf 5/14/2015
AP01/30/2015SE841753037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021977Orig1s036,s037ltr.pdf 2/2/2015
AP04/17/2015SLR42574039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021977Orig1s039ltr.pdf 4/20/2015
AP04/17/2015SLR42606039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021977s039lbl.pdf 4/21/2015
AP012/4/2015SCM       
AP010/14/2016SE847376041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021977s041s042lbl.pdf 10/17/2016
AP010/14/2016SE847387041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021977Orig1s041,s042ltr.pdf 10/19/2016
AP010/14/2016SLR47388042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021977Orig1s041,s042ltr.pdf 10/19/2016
AP010/14/2016SLR47375042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021977s041s042lbl.pdf 10/17/2016




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