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FDA Drug Application 205858 by GILEAD SCIENCES INC

Application Number205858
Application Type New Drug Application
Sponsor ApplicantGILEAD SCIENCES INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP07/23/2014N39923000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205858lbl.pdf 7/23/2014
AP07/23/2014N39959000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205858Orig1s000ltr.pdf 7/24/2014
AP07/23/2014N40093000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=321 8/1/2014
AP07/23/2014N41794000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205858Orig1s000TOC.cfm 2/6/2015
AP07/23/2014N41795000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205858Orig1s000SumR.pdf 2/6/2015
AP09/1/2015SCM       
AP01/19/2016SCM       
AP09/21/2016SLR47149004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205858Orig1s004ltr.pdf 9/22/2016
AP09/21/2016SLR47190004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205858s004lbl.pdf 9/29/2016
AP09/21/2016SLR47326004   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM524810.pdf 10/12/2016




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