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FDA Drug Application 203094 by GILEAD SCIENCES INC

Application Number203094
Application Type New Drug Application
Sponsor ApplicantGILEAD SCIENCES INC
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
AP09/24/2014N40609000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203094Orig1s000ltr.pdf 9/26/2014
AP09/24/2014N40647000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203094Orig2s000ltr.pdf 9/29/2014
AP09/24/2014N40711000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203094s000lbl.pdf 10/3/2014
AP09/24/2014N42933000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/203094Orig1Orig2s000TOC.cfm 5/28/2015
AP09/24/2014N42935000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/203094Orig1Orig2s000SumR.pdf 5/28/2015
AP19/24/2014N40609000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203094Orig1s000ltr.pdf 9/26/2014
AP19/24/2014N40647000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203094Orig2s000ltr.pdf 9/29/2014
AP19/24/2014N40711000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203094s000lbl.pdf 10/3/2014
AP19/24/2014N42933000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/203094Orig1Orig2s000TOC.cfm 5/28/2015
AP19/24/2014N42935000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/203094Orig1Orig2s000SumR.pdf 5/28/2015
AP04/15/2015SCM       
AP04/17/2015SCM       
AP011/25/2015SE844612003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203094Orig1s003ltr.pdf 11/27/2015
AP011/25/2015SE844640003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203094Orig1s003lbl.pdf 12/1/2015
AP04/15/2016SCM       
AP06/17/2016SLR46369005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203094Orig1s005ltr.pdf 6/21/2016
AP06/17/2016SLR46384005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203094s005lbl.pdf 6/21/2016




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