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FDA Drug Application 022511 by HORIZON PHARMA USA

Application Number022511
Application Type New Drug Application
Sponsor ApplicantHORIZON PHARMA USA
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP04/30/2010N25483000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022511lbl.pdf 5/7/2010
AP04/30/2010N25517000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022511s000ltr.pdf 5/7/2010
AP04/30/2010N27974000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022511Orig1s000TOC.cfm 2/28/2011
AP04/30/2010N27988000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022511Orig1s000SumR.pdf 2/28/2011
AP04/30/2010N31639000Medication Guide  http://www.fda.gov/downloads/Drugs/DrugSafety/UCM213832.pdf 2/3/2012
AP04/30/2010N31079000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm213259.htm 12/20/2011
AP011/18/2011SLR30746001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022511s001ltr.pdf 11/22/2011
AP011/18/2011SLR30791001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022511s001lbl.pdf 11/29/2011
AP06/21/2011SLR29322002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022511s002s003lbl.pdf 6/29/2011
AP06/21/2011SLR29359002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022511s002,s003ltr.pdf 6/29/2011
AP06/21/2011SLR29360003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022511s002,s003ltr.pdf 6/29/2011
AP06/21/2011SLR29323003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022511s002s003lbl.pdf 6/29/2011
AP05/20/2011SLR28937004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022511s004ltr.pdf 5/25/2011
AP05/20/2011SLR28968004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022511s004lbl.pdf 5/26/2011
AP01/20/2012SLR31459006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022511s006ltr.pdf 1/23/2012
AP01/20/2012SLR31500006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022511s006lbl.pdf 1/24/2012
AP09/28/2012SLR33950007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022511Orig1s007ltr.pdf 10/3/2012
AP09/28/2012SLR33980007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022511s007lbl.pdf 10/4/2012
AP09/28/2012SLR33981007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022511s007mg.pdf 10/4/2012
AP010/9/2012SLR34034008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022511Orig1s008ltr.pdf 10/11/2012
AP010/9/2012SLR34076008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022511s008lbl.pdf 10/12/2012
AP010/9/2012SLR34077008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022511s008mg.pdf 10/12/2012
AP06/12/2013SCM       
AP03/27/2014SLR38927010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022511Orig1s010ltr.pdf 3/28/2014
AP03/27/2014SLR38940010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022511s010lbl.pdf 4/1/2014
AP03/20/2014SCM       
AP02/25/2014SLR38609012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022511Orig1s012ltr.pdf 2/27/2014
AP02/25/2014SLR38625012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022511s012lbl.pdf 2/27/2014
AP05/14/2014SCM       
AP08/27/2014SCM       
AP03/25/2015SLR42293015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022511Orig1s015ltr.pdf 3/26/2015
AP03/25/2015SLR42759015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022511s015lbl.pdf 5/8/2015
AP06/19/2015SLR43103016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022511Orig1s016ltr.pdf 6/23/2015
AP06/19/2015SLR43104016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022511s016lbl.pdf 6/23/2015
AP012/19/2014SLR41376017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022511Orig1s017ltr.pdf 12/23/2014
AP012/19/2014SLR41429017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022511s017lbl.pdf 12/29/2014
AP05/9/2016SLR45902018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022511Orig1s018ltr.pdf 5/10/2016
AP05/9/2016SLR45989018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022511s018lbl.pdf 5/11/2016
AP010/24/2016SLR47446020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022511Orig1s020ltr.pdf 10/26/2016
AP010/24/2016SLR47521020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022511s020lbl.pdf 10/31/2016




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