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FDA Drug Application 205109 by VIFOR FRESENIUS

Application Number205109
Application Type New Drug Application
Sponsor ApplicantVIFOR FRESENIUS
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
AP011/27/2013N37957000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205109Orig1s000ltr.pdf 11/29/2013
AP011/27/2013N38872000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/205109s000lbl.pdf 3/24/2014
AP011/27/2013N40178000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/205109Orig1s000TOC.cfm 8/7/2014
AP011/27/2013N40179000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/205109Orig1s000SumR.pdf 8/7/2014
AP09/24/2014SLR40610001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205109Orig1s001ltr.pdf 9/26/2014
AP09/24/2014SLR40638001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205109s001lbl.pdf 9/26/2014
AP06/12/2015SCM       




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