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FDA Drug Application 205579 by EAGLE PHARMS

Application Number205579
Application Type New Drug Application
Sponsor ApplicantEAGLE PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP07/22/2014N39971000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205579s000lbl.pdf 7/24/2014
AP07/22/2014N39992000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205579Orig1s000ltr.pdf 7/24/2014
AP07/22/2014N45487000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205579Orig1s000TOC.cfm 3/23/2016
AP07/22/2014N45488000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205579Orig1s000SumR.pdf 3/23/2016
AP010/1/2015SCM       




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