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FDA Drug Application 206289 by AKORN

Application Number206289
Application Type New Drug Application
Sponsor ApplicantAKORN
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type Drug already marketed, but without an approved NDA
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP07/18/2014N39940000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206289Orig1s000ltr.pdf 7/23/2014
AP07/18/2014N39947000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206289s000lbl.pdf 7/23/2014
AP07/18/2014N42440000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206289Orig1s000TOC.cfm 4/7/2015
AP07/18/2014N42441000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206289Orig1s000SumR.pdf 4/7/2015




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