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FDA Drug Application 204671 by GILEAD SCIENCES INC

Application Number204671
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 Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/6/2013N37990000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204671Orig1s000ltr.pdf 12/9/2013
AP012/6/2013N38012000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204671s000lbl.pdf 12/12/2013
AP012/6/2013N38367000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204671Orig1s000TOC.cfm 1/27/2014
AP012/6/2013N38368000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204671Orig1s000SumR.pdf 1/27/2014
AP011/14/2014SLR41009001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204671Orig1s001ltr.pdf 11/18/2014
AP011/14/2014SLR41041001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204671s001lbl.pdf 11/20/2014
AP08/19/2015SLR43683002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204671s002lbl.pdf 8/20/2015
AP08/19/2015SLR43686002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204671Orig1s002ltr.pdf 8/21/2015
AP03/20/2015SLR42241004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204671Orig1s004ltr.pdf 3/24/2015
AP03/20/2015SLR42259004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204671s004lbl.pdf 3/24/2015
AP09/28/2016SCM       




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