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FDA Drug Application 203049 by HIKMA PHARM CO LTD

Application Number203049
Application Type New Drug Application
Sponsor ApplicantHIKMA PHARM CO LTD
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
AP01/5/2012N31366000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203049s000lbl.pdf 1/6/2012
AP01/5/2012N31369000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203049s000ltr.pdf 1/9/2012
AP01/5/2012N36191000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203049_argatroban_toc.cfm 6/4/2013
AP01/5/2012N36192000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203049Orig1s000SumR.pdf 6/4/2013
AP02/13/2013SCM       
AP010/16/2014SCM       
AP09/30/2016SLR47252004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203049Orig1s004ltr.pdf 10/3/2016
AP09/30/2016SLR47302004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203049s004lbl.pdf 10/6/2016
AP05/26/2016SLR46174005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203049Orig1s005ltr.pdf 5/27/2016
AP05/26/2016SLR46223005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203049s005lbl.pdf 6/1/2016




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