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FDA Drug Application 022036 by PERNIX THERAPS LLC

Application Number022036
Application Type New Drug Application
Sponsor ApplicantPERNIX THERAPS LLC
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
AP03/17/2010N25072000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022036lbl.pdf 3/18/2010
AP03/17/2010N25085000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022036s000ltr.pdf 3/22/2010
AP03/17/2010N25147000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM206668.pdf 3/31/2010
AP03/17/2010N27814000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022036s000_silenor_toc.cfm 2/11/2011
AP03/17/2010N27815000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022036Orig1s000SumR.pdf 2/11/2011
AP010/30/2011SLR31416001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022036s001ltr.pdf 1/20/2012
AP08/8/2014SCM       




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