Back to FDA Applications sponsored by GILEAD SCIENCES INC

FDA Drug Application 206545 by GILEAD SCIENCES INC

Application Number206545
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 Priority
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP07/23/2014N39922000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206545lbl.pdf 7/23/2014
AP07/23/2014N39924000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206545Orig1s000ltr.pdf 7/23/2014
AP07/23/2014N40094000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=321 8/1/2014
AP07/23/2014N40215000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206545Orig1s000TOC.cfm 8/13/2014
AP07/23/2014N40216000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206545Orig1s000SumR.pdf 8/13/2014




Back to FDA Applications sponsored by GILEAD SCIENCES INC