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FDA Drug Application 020333 by SHIRE LLC

Application Number020333
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 Priority
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/14/1997N       
AP011/7/1997SCM       
AP012/16/1998SE1735002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20333S2ltr.pdf 12/16/1998
AP012/16/1998SE1736002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20333-S002_Agrylin.pdf 12/16/1998
AP012/16/1998SE1737002   http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20333S2lbl.pdf 12/16/1998
AP08/19/1999SCM       
AP03/13/2000SLR       
AP011/3/2000SCM       
AP03/15/2002SCM       
AP010/10/2002SCM       
AP012/10/2004SE510791008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20333s008,009lbl.pdf 12/10/2004
AP012/10/2004SE510792008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20333s008,009ltr.pdf 12/10/2004
AP012/10/2004SLR10793009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20333s008,009lbl.pdf 12/10/2004
AP012/10/2004SLR10794009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20333s008,009ltr.pdf 12/10/2004
AP012/17/2004SLR10859010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20333s010ltr.pdf 12/30/2004
AP012/17/2004SLR10892010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20333s010lbl.pdf 12/30/2004
AP06/17/2008SLR20039013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020333s013lbl.pdf 6/19/2008
AP06/17/2008SLR20043013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020333s013ltr.pdf 6/20/2008
AP06/17/2008SLR43692013   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/020333Orig1s013.pdf 8/21/2015
AP07/9/2009SLR22981015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020333s015ltr.pdf 7/17/2009
AP07/9/2009SLR23036015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020333s015lbl.pdf 7/23/2009
AP06/30/2010SLR25908016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020333s016ltr.pdf 7/2/2010
AP06/30/2010SLR25923016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020333s016lbl.pdf 7/6/2010
AP01/31/2011SLR27650017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020333s017lbl.pdf 1/31/2011
AP01/31/2011SLR27707017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020333s017ltr.pdf 2/4/2011
AP011/22/2011SLR30782019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020333s019ltr.pdf 11/28/2011
AP011/22/2011SLR30811019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020333s019lbl.pdf 11/30/2011
AP07/17/2013SLR36577020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020333Orig1s020ltr.pdf 7/19/2013
AP07/17/2013SLR36593020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020333s020lbl.pdf 7/23/2013
AP02/7/2014SLR38481021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020333s021lbl.pdf 2/10/2014
AP02/7/2014SLR38495021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020333Orig1s021ltr.pdf 2/11/2014
AP010/30/2014SLR40917022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020333Orig1s022ltr.pdf 11/3/2014
AP010/30/2014SLR40941022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020333s022lbl.pdf 11/4/2014
AP07/14/2015SLR43378023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020333Orig1s023ltr.pdf 7/15/2015
AP07/14/2015SLR43397023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020333s023lbl.pdf 7/16/2015




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