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FDA Drug Application 205488 by AYTU BIOSCIENCE INC

Application Number205488
Application Type New Drug Application
Sponsor ApplicantAYTU BIOSCIENCE INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP05/28/2014N39406000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205488s000lbl.pdf 5/30/2014
AP05/28/2014N39416000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205488Orig1s000ltr.pdf 6/2/2014
AP05/28/2014N41718000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205488Orig1s000TOC.cfm 1/29/2015
AP05/28/2014N41719000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205488Orig1s000SumR.pdf 1/29/2015
AP05/11/2015SLR42792001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205488Orig1s001ltr.pdf 5/13/2015
AP05/11/2015SLR42811001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205488s001lbl.pdf 5/13/2015
AP010/25/2016SLR47485002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205488Orig1s002ltr.pdf 10/27/2016




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