Back to FDA Applications sponsored by EXELTIS SUISSE

FDA Drug Application 205175 by EXELTIS SUISSE

Application Number205175
Application Type New Drug Application
Sponsor ApplicantEXELTIS SUISSE
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
AP010/24/2013N37566000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205175Orig1s000ltr.pdf 10/25/2013
AP010/24/2013N37582000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/205175s000lbl.pdf 10/25/2013
AP010/24/2013N39681000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/205175Orig1s000TOC.cfm 6/27/2014
AP010/24/2013N39682000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/205175Orig1s000SumR.pdf 6/27/2014
AP08/1/2016SCM       
AP08/16/2016SCM       




Back to FDA Applications sponsored by EXELTIS SUISSE