Back to FDA Applications sponsored by OMEROS

FDA Drug Application 205388 by OMEROS

Application Number205388
Application Type New Drug Application
Sponsor ApplicantOMEROS
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
AP05/30/2014N39429000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205388Orig1s000ltr.pdf 6/3/2014
AP05/30/2014N39439000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205388s000lbl.pdf 6/3/2014
AP05/30/2014N41185000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205388Orig1s000TOC.cfm 12/9/2014
AP05/30/2014N41188000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205388Orig1s000SumR.pdf 12/9/2014
AP05/21/2015SCM46420001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205388s001lbl.pdf 6/24/2016
AP01/15/2016SCM       
AP07/8/2016SCM       




Back to FDA Applications sponsored by OMEROS