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FDA Drug Application 200792 by PAR PHARM

Application Number200792
Application Type Abbreviated New Drug Application
Sponsor ApplicantPAR PHARM
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
AP010/24/2014N40889000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200792Orig1s000ltr.pdf 10/28/2014
AP010/24/2014N43167000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17 6/30/2015




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