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FDA Drug Application 090819 by ACTAVIS ELIZABETH

Application Number090819
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
AP02/19/2015N41896000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/090819Orig1s000ltr.pdf 2/24/2015
AP02/19/2015N43185000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=9 7/2/2015




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