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FDA Drug Application 200812 by PAR PHARM INC

Application Number200812
Application Type Abbreviated New Drug Application
Sponsor ApplicantPAR PHARM INC
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
AP011/10/2011N37541000   http://www.accessdata.fda.gov/drugsatfda_docs/anda/2011/200812Orig1s000.pdf 10/24/2013
AP011/10/2011N43158000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17 6/30/2015




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