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FDA Drug Application 050686 by PERNIX THERAP

Application Number050686
Application Type New Drug Application
Sponsor ApplicantPERNIX THERAP
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
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       
AP09/10/1996SCS       
AP09/3/1997SCM       
AP03/3/1998SCP       
AP02/16/1999SLR       
AP06/15/1998SLR       
AP010/2/1998SCS       
AP05/19/2000SLR       
AP01/4/2001SCP       
AP02/10/2009SLR21807014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050685s011,050686s014ltr.pdf 2/12/2009
AP02/10/2009SLR21819014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050685s011,050686s014lbl.pdf 2/12/2009
AP011/4/2010SLR26907015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050685s012,050686s015ltr.pdf 11/8/2010
AP03/11/2011SCM28242016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050686s016lbl.pdf 3/14/2011
AP03/11/2011SCM28261016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050686s016ltr.pdf 3/16/2011




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