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FDA Drug Application 204768 by IROKO PHARMS LLC

Application Number204768
Application Type New Drug Application
Sponsor ApplicantIROKO PHARMS LLC
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
AP02/24/2014N38580000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204768s000lbl.pdf 2/25/2014
AP02/24/2014N38596000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204768Orig1s000ltr.pdf 2/26/2014
AP02/24/2014N40176000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204768Orig1s000TOC.cfm 8/7/2014
AP02/24/2014N40177000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204768Orig1s000SumR.pdf 8/7/2014
AP07/15/2015SCM       
AP05/9/2016SLR45952003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204768s003s004lbl.pdf 5/11/2016
AP05/9/2016SLR45894003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204768Orig1s003,s004ltr.pdf 5/10/2016
AP05/9/2016SLR45895004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204768Orig1s003,s004ltr.pdf 5/10/2016
AP05/9/2016SLR45953004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204768s003s004lbl.pdf 5/11/2016
AP05/9/2016SLR46054004   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM501662.pdf 5/18/2016




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