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FDA Drug Application 203849 by ACTAVIS ELIZABETH

Application Number203849
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
AP04/6/2015N42472000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203849Orig1s000ltr.pdf 4/8/2015
AP04/6/2015N42522000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203849Orig1s000MG.pdf 4/14/2015
AP04/6/2015N43157000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17 6/30/2015




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