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FDA Drug Application 204820 by HIKMA INTL PHARMS

Application Number204820
Application Type New Drug Application
Sponsor ApplicantHIKMA INTL PHARMS
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
AP09/26/2014N40652000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204820Orig1s000ltr.pdf 9/30/2014
AP09/26/2014N40664000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204820s000lbl.pdf 9/30/2014
AP09/26/2014N40721000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM417495.pdf 10/6/2014
AP09/26/2014N40757000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204820Orig1s000TOC.cfm 10/10/2014
AP09/26/2014N40758000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204820Orig1s000SumR.pdf 10/10/2014
AP09/30/2016SCM       




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