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FDA Drug Application 205874 by KERYX BIOPHARMS

Application Number205874
Application Type New Drug Application
Sponsor ApplicantKERYX BIOPHARMS
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
AP09/5/2014N40449000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205874Orig1s000ltr.pdf 9/8/2014
AP09/5/2014N40465000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205874s000lbl.pdf 9/9/2014
AP09/5/2014N42616000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205874Orig1s000TOC.cfm 4/22/2015
AP09/5/2014N42620000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205874Orig1s000SumR.pdf 4/22/2015
AP011/15/2014SLR41005001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205874Orig1s001ltr.pdf 11/17/2014
AP011/15/2014SLR41052001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205874s001lbl.pdf 11/20/2014
AP05/18/2015SCM       
AP05/22/2015SCM       
AP07/21/2015SLR43453004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205874s004lbl.pdf 7/22/2015
AP07/21/2015SLR43466004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205874Orig1s004ltr.pdf 7/23/2015
AP07/14/2015SCM       
AP08/4/2015SCM       
AP08/27/2015SCM       
AP05/2/2016SCM       




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