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FDA Drug Application 091248 by MYLAN PHARMS INC

Application Number091248
Application Type Abbreviated New Drug Application
Sponsor ApplicantMYLAN PHARMS 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
AP01/8/2014N38264000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/091248Orig1s000ltr.pdf 1/14/2014
AP01/8/2014N43243000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=37 7/6/2015




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