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FDA Drug Application 204278 by PADDOCK LLC

Application Number204278
Application Type Abbreviated New Drug Application
Sponsor ApplicantPADDOCK LLC
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
AP04/6/2015N42471000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204278Orig1s000ltr.pdf 4/8/2015
AP04/6/2015N42523000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204278Orig1s000MG.pdf 4/14/2015
AP04/6/2015N43165000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17 6/30/2015




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