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FDA Drug Application 205787 by KALEO INC

Application Number205787
Application Type New Drug Application
Sponsor ApplicantKALEO INC
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
AP04/3/2014N38962000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205787Orig1s000lbl.pdf 4/3/2014
AP04/3/2014N38963000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205787Orig1s000SumR.pdf 4/3/2014
AP04/3/2014N38965000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205787Orig1s000ltr.pdf 4/3/2014
AP04/3/2014N41302000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205787Orig1s000TOC.cfm 12/18/2014
AP05/11/2015SCM       
AP06/6/2016SCM       
AP06/23/2016SCM       




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