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FDA Drug Application 079040 by ACTAVIS ELIZABETH

Application Number079040
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
AP01/16/2013N35262000   http://www.accessdata.fda.gov/drugsatfda_docs/anda/2013/079040Orig1s000Approv.pdf 2/27/2013
AP01/16/2013N43152000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17 6/30/2015




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