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FDA Drug Application 091422 by ACTAVIS ELIZABETH

Application Number091422
Application Type Abbreviated New Drug Application
Sponsor ApplicantACTAVIS ELIZABETH
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP02/22/2013N35241000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/091422Orig1s000ltr.pdf 2/26/2013
AP02/22/2013N43190000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=9 7/2/2015
AP05/15/2014SCM39397006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/091422Orig1s006ltr.pdf 5/29/2014




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