Back to FDA Applications sponsored by HORIZON PHARMA

FDA Drug Application 202020 by HORIZON PHARMA

Application Number202020
Application Type New Drug Application
Sponsor ApplicantHORIZON PHARMA
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
AP07/26/2012N33292000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202020Orig1s000ltr.pdf 7/30/2012
AP07/26/2012N33312000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202020s000lbl.pdf 7/30/2012
AP07/26/2012N36140000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202020_rayos_toc.cfm 5/24/2013
AP07/26/2012N36141000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202020Orig1s000SumR.pdf 5/24/2013
AP03/13/2013SCM       
AP06/13/2013SLR36309003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202020s003lbl.pdf 6/18/2013
AP06/13/2013SLR36328003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202020Orig1s003ltr.pdf 6/18/2013
AP010/25/2013SCM       
AP05/12/2014SCM       
AP02/10/2014SCM       
AP08/12/2014SCM       
AP02/5/2016SCM       
AP07/22/2016SCM       




Back to FDA Applications sponsored by HORIZON PHARMA

Problems, Comments, Suggestions? Click here to contact Greg Thatcher

Please read my Disclaimer





Copyright (c) 2013 Thatcher Development Software, LLC. All rights reserved. No claim to original U.S. Gov't works.