Back to FDA Applications sponsored by HORIZON PHARMA

FDA Drug Application 204623 by HORIZON PHARMA

Application Number204623
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
AP01/16/2014N40724000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204623Orig1s000TOC.cfm 10/7/2014
AP01/16/2014N40725000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204623Orig1s000SumR.pdf 10/7/2014
AP01/16/2014N38324000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204623Orig1s000ltr.pdf 1/17/2014
AP01/16/2014N38332000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204623s000lbl.pdf 1/17/2014
AP07/21/2014SCM       
AP07/10/2014SCM39838002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204623s002lbl.pdf 7/11/2014
AP011/5/2014SLR40957003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204623Orig1s003ltr.pdf 11/7/2014
AP011/5/2014SLR40960003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204623s003lbl.pdf 11/7/2014
AP05/6/2015SCP       
AP05/9/2016SLR45896005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204623Orig1s005ltr.pdf 5/10/2016
AP05/9/2016SLR45970005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204623s005lbl.pdf 5/11/2016




Back to FDA Applications sponsored by HORIZON PHARMA