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FDA Drug Application 022396 by JAVELIN PHARMS INC

Application Number022396
Application Type New Drug Application
Sponsor ApplicantJAVELIN PHARMS INC
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
AP012/23/2014N41430000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022396Orig1s000ltr.pdf 12/30/2014
AP012/23/2014N41546000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022396s000lbledt.pdf 1/8/2015
AP012/23/2014N45176000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/022396Orig1s000TOC.cfm 2/16/2016
AP07/15/2015SCM       
AP05/27/2015SCM       
AP05/9/2016SLR45903003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022396Orig1s003ltr.pdf 5/10/2016
AP05/9/2016SLR45983003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022396s003lbl.pdf 5/11/2016




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