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FDA Drug Application 202123 by GILEAD SCIENCES INC

Application Number202123
Application Type New Drug Application
Sponsor ApplicantGILEAD SCIENCES INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP08/10/2011N29746000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202123s000lbl.pdf 8/11/2011
AP08/10/2011N29767000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202123s000ltr.pdf 8/12/2011
AP08/10/2011N33658000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202123_compleratm_toc.cfm 9/6/2012
AP08/10/2011N33659000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202123Orig1s000SumR.pdf 9/6/2012
AP01/25/2013SE835001003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202123Orig1s003ltr.pdf 1/30/2013
AP01/25/2013SE835016003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202123s003lbl.pdf 1/30/2013
AP08/10/2012SLR33440006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202123Orig1s006ltr.pdf 8/15/2012
AP08/10/2012SLR33474006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202123s006lbl.pdf 8/15/2012
AP03/26/2013SCM       
AP04/19/2013SCM       
AP05/10/2013SCM       
AP06/20/2013SLR36363011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202123Orig1s011ltr.pdf 6/21/2013
AP06/20/2013SLR36382011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202123s011lbl.pdf 6/25/2013
AP012/13/2013SE838067012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202123Orig1s012ltr.pdf 12/17/2013
AP012/13/2013SE838092012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202123s012lbl.pdf 12/17/2013
AP011/8/2013SCM       
AP010/23/2013SLR37552015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202123Orig1s015ltr.pdf 10/25/2013
AP010/23/2013SLR37572015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202123s015lbl.pdf 10/25/2013
AP06/5/2014SLR39455016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202123Orig1s016ltr.pdf 6/10/2014
AP06/5/2014SLR39495016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202123s016lbl.pdf 6/10/2014
AP07/11/2014SCM       
AP09/16/2014SLR40507018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202123Orig1s018ltr.pdf 9/17/2014
AP09/16/2014SLR40692018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202123s018lbl.pdf 10/2/2014
AP05/5/2015SLR42763020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202123Orig1s020ltr.pdf 5/11/2015
AP05/5/2015SLR42779020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202123s020lbl.pdf 5/12/2015
AP02/23/2016SE845261021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202123Orig1s021,s024.pdf 2/25/2016
AP012/29/2015SCM       
AP02/9/2016SLR45144023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202123Orig1s023ltr.pdf 2/11/2016
AP02/9/2016SLR45216023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202123s023lbl.pdf 2/19/2016
AP02/23/2016SLR45262024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202123Orig1s021,s024.pdf 2/25/2016
AP02/23/2016SLR45276024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202123s021s024lbl.pdf 2/25/2016
AP03/9/2016SCM       




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