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FDA Drug Application 022037 by SHIRE

Application Number022037
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
AP09/2/2009N23284000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022037s000ltr.pdf 9/10/2009
AP09/2/2009N23522000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022037lbl.pdf 10/1/2009
AP09/2/2009N25943000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022037_intuniv_toc.cfm 7/9/2010
AP09/2/2009N25944000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022037s000sumr.pdf 7/9/2010
AP02/25/2011SE528017002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022037s002ltr.pdf 3/2/2011
AP02/25/2011SE528052002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022037s002lbl.pdf 3/4/2011
AP06/8/2011SLR29104006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022037s006lbl.pdf 6/10/2011
AP06/8/2011SLR29109006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022037s006ltr.pdf 6/10/2011
AP02/20/2013SE835211008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022037s008lbl.pdf 2/21/2013
AP02/20/2013SE835227008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022037Orig1s008ltr.pdf 2/25/2013
AP08/23/2013SLR36892009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022037s009lbl.pdf 8/27/2013
AP08/23/2013SLR36902009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022037Orig1s009ltr.pdf 8/27/2013
AP011/19/2014SE841037010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022037Orig1s010ltr.pdf 11/20/2014
AP011/19/2014SE841061010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022037s010lbl.pdf 11/20/2014
AP03/18/2015SE842194011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022037s011lbl.pdf 3/19/2015
AP03/18/2015SE842211011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022037Orig1s011ltr.pdf 3/19/2015
AP07/7/2016SLR46481013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022037s013lbl.pdf 7/8/2016
AP07/7/2016SLR46494013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022037Orig1s013ltr.pdf 7/12/2016




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