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FDA Drug Application 200535 by LEHIGH VALLEY

Application Number200535
Application Type New Drug Application
Sponsor ApplicantLEHIGH VALLEY
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type Drug already marketed, but without an approved NDA
Therapeutic Potential Standard
Orphan Code 

Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/20/2010N26726000 10/21/2010
AP010/20/2010N26733000 10/25/2010
AP010/20/2010N26824000 10/29/2010
AP010/20/2010N27964000 2/24/2011
AP010/20/2010N27965000 2/24/2011
AP01/25/2012SLR31576004 1/30/2012
AP08/22/2013SLR36886006 8/27/2013
AP08/22/2013SLR36955006,s008ltr.pdf 9/5/2013
AP08/22/2013SCM36956008,s008ltr.pdf 9/5/2013
AP08/22/2013SCM36887008 8/27/2013
AP06/20/2014SCM39635009 6/23/2014

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