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FDA Drug Application 200197 by ALKEM LABS LTD

Application Number200197
Application Type Abbreviated New Drug Application
Sponsor ApplicantALKEM LABS LTD
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
AP07/12/2013N43215000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=37 7/2/2015




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