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FDA Drug Application 204819 by BAYER HLTHCARE

Application Number204819
Application Type New Drug Application
Sponsor ApplicantBAYER HLTHCARE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan CodeV

Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/8/2013N37403000 10/10/2013
AP010/8/2013N37419000REMS 10/15/2013
AP010/8/2013N37449000 10/17/2013
AP010/8/2013N37545000 10/24/2013
AP010/8/2013N37687000 11/5/2013
AP010/8/2013N37688000 11/5/2013
AP06/11/2014S39520001 6/12/2014
AP05/6/2014SLR39244002 5/8/2014
AP05/6/2014SLR39284002 5/12/2014
AP012/4/2015S44668004 12/7/2015
AP010/4/2016S47293007 10/6/2016

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