Back to FDA Applications sponsored by HIKMA PHARMS

FDA Drug Application 205917 by HIKMA PHARMS

Application Number205917
Application Type New Drug Application
Sponsor ApplicantHIKMA PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP011/18/2014N41027000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205917Orig1s000ltr.pdf 11/19/2014
AP011/18/2014N41060000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205917s000lbl.pdf 11/20/2014
AP011/18/2014N41720000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205917Orig1s000TOC.cfm 1/29/2015




Back to FDA Applications sponsored by HIKMA PHARMS