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FDA Drug Application 022519 by HORIZON PHARMA

Application Number022519
Application Type New Drug Application
Sponsor ApplicantHORIZON PHARMA
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
AP04/23/2011N28611000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022519s000lbl.pdf 4/26/2011
AP04/23/2011N28612000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022519s000MedG.pdf 4/26/2011
AP04/23/2011N28619000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022519s000ltr.pdf 4/28/2011
AP04/23/2011N30465000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022519_duexis_toc.cfm 11/2/2011
AP04/23/2011N30466000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022519Orig1s000SumR.pdf 11/2/2011
AP08/13/2013SCM       
AP01/18/2013SCM       
AP010/31/2013SLR       
AP08/28/2013SCM       
AP03/4/2014SCM       
AP05/9/2016SLR45901009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022519Orig1s009ltr.pdf 5/10/2016
AP05/9/2016SLR45990009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022519s009lbl.pdf 5/11/2016
AP07/8/2016SCM       




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