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FDA Drug Application 204592 by IROKO PHARMS LLC

Application Number204592
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
AP010/18/2013N37494000 10/22/2013
AP010/18/2013N37519000 10/22/2013
AP010/18/2013N37548000 10/24/2013
AP010/18/2013N38911000 3/26/2014
AP010/18/2013N38912000 3/26/2014
AP08/22/2014SE840316002 8/26/2014
AP08/22/2014SE840319002,s004ltr.pdf 8/27/2014
AP08/22/2014SE840320004,s004ltr.pdf 8/27/2014
AP08/22/2014SE840317004 8/26/2014
AP05/9/2016SLR45968007 5/11/2016
AP05/9/2016SLR45897007,s008ltr.pdf 5/10/2016
AP05/9/2016SLR45898008,s008ltr.pdf 5/10/2016
AP05/9/2016SLR45969008 5/11/2016

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