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FDA Drug Application 050685 by PERNIX THERAP

Application Number050685
Application Type New Drug Application
Sponsor ApplicantPERNIX THERAP
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/20/1995N       
AP010/9/1996SLR       
AP05/21/1997SLR       
AP012/26/1996SCP       
AP09/3/1997SCM       
AP02/16/1999SLR       
AP07/23/1999SCS       
AP05/19/2000SLR       
AP02/10/2009SLR21806011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050685s011,050686s014ltr.pdf 2/12/2009
AP02/10/2009SLR21818011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050685s011,050686s014lbl.pdf 2/12/2009
AP011/4/2010SLR26906012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050685s012,050686s015ltr.pdf 11/8/2010




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