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FDA Drug Application 065095 by HIKMA INTL PHARMS

Application Number065095
Application Type Abbreviated New Drug Application
Sponsor ApplicantHIKMA INTL PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP07/2/2003N       
AP06/25/2014SLR39967014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/065095Orig1s014ltr.pdf 7/24/2014
AP06/25/2014SLR40070014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/065095Orig1s014lbl.pdf 7/30/2014




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