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FDA Drug Application 204399 by UPSHER-SMITH LABS

Application Number204399
Application Type New Drug Application
Sponsor ApplicantUPSHER-SMITH LABS
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
TA08/16/2013TA36848000 8/21/2013
AP16/4/2014N36848000 8/21/2013
TA08/16/2013TA39450000 6/5/2014
AP16/4/2014N39450000 6/5/2014
TA08/16/2013TA39496000 6/10/2014
AP16/4/2014N39496000 6/10/2014
TA08/16/2013TA39668000REMS 6/26/2014
AP16/4/2014N39668000REMS 6/26/2014
TA08/16/2013TA42617000 4/22/2015
AP16/4/2014N42617000 4/22/2015
TA08/16/2013TA42619000 4/22/2015
AP16/4/2014N42619000 4/22/2015
AP05/11/2015SLR42791002 5/13/2015
AP05/11/2015SLR42814002 5/13/2015
AP05/11/2015SLR42920002 5/27/2015
AP010/25/2016SLR47484004 10/27/2016

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