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FDA Drug Application 205834 by GILEAD SCIENCES INC

Application Number205834
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
AP010/10/2014N40759000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205834Orig1s000ltr.pdf 10/14/2014
AP010/10/2014N40786000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205834s000lbl.pdf 10/15/2014
AP010/10/2014N40925000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205834Orig1s000TOC.cfm 11/3/2014
AP010/10/2014N40926000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205834Orig1s000SumR.pdf 11/3/2014
AP03/20/2015SLR42243001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205834Orig1s001ltr.pdf 3/24/2015
AP03/20/2015SLR42260001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205834s001lbl.pdf 3/24/2015
AP011/12/2015SE844477002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205834Orig1s002ltr.pdf 11/16/2015
AP011/12/2015SE844534002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205834s002lbl.pdf 11/19/2015
AP011/12/2015SE844479003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205834Orig1s003,s005ltr.pdf 11/16/2015
AP011/12/2015SE844528003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205834s003s005lbl.pdf 11/19/2015
AP011/12/2015SE844480004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205834Orig1s004ltr.pdf 11/16/2015
AP011/12/2015SE844530004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205834s004lbl.pdf 11/19/2015
AP011/12/2015SE844478005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205834Orig1s003,s005ltr.pdf 11/16/2015
AP011/12/2015SE844529005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205834s003s005lbl.pdf 11/19/2015
AP011/12/2015SE844481006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205834Orig1s006ltr.pdf 11/16/2015
AP011/12/2015SE844533006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205834s006lbl.pdf 11/19/2015
AP02/12/2016SE545173007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205834Orig1s007,s008,s009ltr.pdf 2/16/2016
AP02/12/2016SE545264007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205834s007s008s009lbl.pdf 2/25/2016
AP02/12/2016SE545327007   http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2016/205834Orig1s007, s008, s009SumR.pdf 3/3/2016
AP02/12/2016SE546872007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/205834Orig1s007s008s009TOC.cfm 8/24/2016
AP02/12/2016SE845172008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205834Orig1s007,s008,s009ltr.pdf 2/16/2016
AP02/12/2016SE845265008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205834s007s008s009lbl.pdf 2/25/2016
AP02/12/2016SE845328008   http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2016/205834Orig1s007, s008, s009SumR.pdf 3/3/2016
AP02/12/2016SE846873008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/205834Orig1s007s008s009TOC.cfm 8/24/2016
AP02/12/2016SE845171009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205834Orig1s007,s008,s009ltr.pdf 2/16/2016
AP02/12/2016SE845266009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205834s007s008s009lbl.pdf 2/25/2016
AP02/12/2016SE845329009   http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2016/205834Orig1s007, s008, s009SumR.pdf 3/3/2016
AP02/12/2016SE846874009   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/205834Orig1s007s008s009TOC.cfm 8/24/2016
AP06/8/2016SLR46278010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205834Orig1s010ltr.pdf 6/9/2016
AP06/8/2016SLR46305010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205834s010lbl.pdf 6/13/2016
AP02/17/2016SLR45553011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205834Orig1s011Lbl.pdf 3/30/2016
AP02/17/2016SLR45560011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205834Orig1s011ltr.pdf 3/31/2016
AP06/22/2016SCM       
AP09/29/2016SCM       
AP010/11/2016SCM       




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