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FDA Drug Application 204242 by OREXO US INC

Application Number204242
Application Type New Drug Application
Sponsor ApplicantOREXO US INC
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
AP07/3/2013N36473000 7/5/2013
AP07/3/2013N36498000 7/8/2013
AP07/3/2013N36594000REMS 7/23/2013
AP07/3/2013N36600000 7/24/2013
AP07/3/2013N39680000 6/27/2014
AP09/4/2013S36988002 9/9/2013
AP012/11/2014SCM41232003 12/12/2014
AP012/11/2014SCM41760003 2/3/2015
AP08/10/2015SE843620004 8/11/2015
AP08/10/2015SE843625004 8/11/2015
AP02/12/2015S41850005 2/17/2015
AP06/4/2015SCM43011006 6/10/2015
AP06/4/2015SCM43023006 6/10/2015
AP010/4/2016S47294007 10/6/2016
AP010/4/2016S47309007 10/7/2016
AP07/7/2016S46490008 7/12/2016

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