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FDA Drug Application 021752 by GILEAD

Application Number021752
Application Type New Drug Application
Sponsor ApplicantGILEAD
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
AP08/2/2004N9937000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21752ltr.pdf 8/5/2004
AP08/2/2004N9946000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21752lbl.pdf 8/5/2004
AP08/2/2004N13570000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021752s000_TruvadaTOC.cfm 1/31/2006
AP08/2/2004N33202000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=62 7/16/2012
AP08/2/2004N36398000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM312307.pdf 6/28/2013
AP03/25/2005SLR11309002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21752s002ltr.pdf 3/30/2005
AP03/25/2005SLR11310002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21752s002lbl.pdf 3/30/2005
AP03/25/2005SLR20331002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021752_S002_TRUVADA.pdf 7/30/2008
AP03/8/2006SE713742005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021752s005lbl.pdf 3/10/2006
AP03/8/2006SE713823005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021752s005ltr.pdf 3/23/2006
AP010/5/2005SLR12851006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021752s006lbl.pdf 10/10/2005
AP010/5/2005SLR12860006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021752s006ltr.pdf 10/11/2005
AP05/21/2007SLR16600011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021356s021, 021752s011ltr.pdf 5/29/2007
AP05/21/2007SLR16648011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021356s021,021752s011lbl.pdf 5/29/2007
AP05/16/2008SE819858016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021752s016ltr.pdf 5/21/2008
AP011/4/2008SLR21181017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021752s017lbl.pdf 11/7/2008
AP011/4/2008SLR21202017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021752s017ltr.pdf 11/7/2008
AP011/6/2009SLR24031019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021752s019lbl.pdf 11/19/2009
AP011/6/2009SLR24570019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021752s019ltr.pdf 1/21/2010
AP01/15/2010SCM       
AP07/8/2011SLR29475027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021752s027ltr.pdf 7/12/2011
AP07/8/2011SLR29503027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021752s027lbl.pdf 7/12/2011
AP07/16/2012SE133199030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021752s030lbl.pdf 7/16/2012
AP07/16/2012SE133200030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021752s030mg.pdf 7/16/2012
AP07/16/2012SE133201030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021752Orig1s030ltr.pdf 7/16/2012
AP07/16/2012SE133331030   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021752_truvada_toc.cfm 8/2/2012
AP07/16/2012SE133332030   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021752Orig1s030SumR.pdf 8/2/2012
AP07/16/2012SLR33209031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021752Orig1s031ltr.pdf 7/17/2012
AP07/16/2012SLR33214031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021752s031lbl.pdf 7/18/2012
AP07/16/2012SLR33217031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021752s031mg.pdf 7/18/2012
AP011/27/2013SCM       
AP06/17/2013SLR36296035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021752s035lbl.pdf 6/17/2013
AP06/17/2013SLR36349035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021752Orig1s035ltr.pdf 6/19/2013
AP06/17/2013SCM       
AP08/15/2013SCM       
AP08/21/2013SCM       
AP07/8/2013SCM       
AP011/8/2013SCM       
AP010/23/2013SLR37554042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021752Orig1s042ltr.pdf 10/25/2013
AP010/23/2013SLR37574042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021752s042lbl.pdf 10/25/2013
AP012/16/2013SLR38072043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021752Orig1s043ltr.pdf 12/17/2013
AP012/16/2013SLR38085043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021752s043lbl.pdf 12/17/2013
AP06/18/2014SLR39590044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021752Orig1s044ltr.pdf 6/19/2014
AP07/11/2014SCM       
AP03/10/2016SE845425047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021752Orig1s047ltr.pdf 3/14/2016
AP03/10/2016SE845442047   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021752s047lbl.pdf 3/15/2016
AP02/25/2016SLR45286050   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021752s050lbl.pdf 2/26/2016
AP02/25/2016SLR45297050   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021752Orig1s050ltr.pdf 2/29/2016




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