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FDA Drug Application 021356 by GILEAD SCIENCES INC

Application Number021356
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
AP010/26/2001N2797000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21356ltr.pdf 10/26/2001
AP010/26/2001N2798000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21356lbl.pdf 10/26/2001
AP010/26/2001N2799000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-356_Viread.cfm 10/26/2001
AP012/2/2002SLR2795001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21356slr001ltr.pdf 12/2/2002
AP012/2/2002SLR2796001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21356slr001_Viread_lbl.pdf 12/2/2002
AP08/15/2003SE56569003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21356se5-003ltr.pdf 8/28/2003
AP08/15/2003SE56570003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21356se5-003_viread_lbl.pdf 8/28/2003
AP010/14/2003SLR6813005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21356slr005ltr.pdf 10/16/2003
AP010/14/2003SLR6814005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21356slr005_viread_lbl.pdf 10/16/2003
AP010/31/2003SLR6982006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21356slr006ltr.pdf 11/25/2003
AP010/31/2003SLR7008006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21356slr006_viread_lbl.pdf 12/1/2003
AP07/1/2004SLR9712010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21356slr010ltr.pdf 7/6/2004
AP07/1/2004SLR9718010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21356slr010_viread_lbl.pdf 7/7/2004
AP05/12/2005SE811624011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021356s011ltr.pdf 5/17/2005
AP05/12/2005SE811652011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021356s011lbl.pdf 5/17/2005
AP03/7/2006SE713739016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021356s016lbl.pdf 3/10/2006
AP03/7/2006SE713830016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021356s016ltr.pdf 3/23/2006
AP011/30/2005SLR13197017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021356s017lbl.pdf 12/5/2005
AP011/30/2005SLR13207017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021356s017ltr.pdf 12/5/2005
AP05/21/2007SLR16601021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021356s021, 021752s011ltr.pdf 5/29/2007
AP05/21/2007SLR16649021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021356s021,021752s011lbl.pdf 5/29/2007
AP05/16/2008SE819852024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021356s024ltr.pdf 5/21/2008
AP08/11/2008SE120612025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021356s025ltr.pdf 8/13/2008
AP08/11/2008SE120713025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021356s025lbl.pdf 8/29/2008
AP011/4/2008SLR21139026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021356s026ltr.pdf 11/6/2008
AP011/4/2008SLR21173026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021356s026lbl.pdf 11/7/2008
AP010/7/2009SE823594027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021356s027lbl.pdf 10/14/2009
AP010/7/2009SE823786027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021356s027ltr.pdf 11/10/2009
AP011/10/2009SLR23874028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021356s028lbl.pdf 11/13/2009
AP011/10/2009SLR24605028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021356s028ltr.pdf 1/25/2010
AP01/15/2010SLR       
AP03/24/2010SE825123033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021356s033lbl.pdf 3/26/2010
AP03/24/2010SE825136033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021356s033ltr.pdf 3/29/2010
AP010/1/2010SE526634034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021356s034lbl.pdf 10/12/2010
AP010/1/2010SE526648034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021356s034ltr.pdf 10/13/2010
AP010/14/2010SE826682035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021356s035ltr.pdf 10/19/2010
AP010/14/2010SE826700035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021356s035lbl.pdf 10/19/2010
AP09/19/2011SE830048037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021356s037lbl.pdf 9/20/2011
AP09/19/2011SE830051037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021356s037ltr.pdf 9/21/2011
AP01/18/2012S31419038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021356s038ltr.pdf 1/20/2012
AP01/18/2012S31631038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021356s038lbl.pdf 2/1/2012
AP08/7/2012SE833411040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021356s040,022577s001lbl.pdf 8/8/2012
AP08/7/2012SE833414040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021356Orig1s040,022577Orig1s001ltr.pdf 8/9/2012
AP011/18/2011SLR30740041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021356s041ltr.pdf 11/22/2011
AP011/18/2011SLR30752041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021356s041lbl.pdf 11/22/2011
AP08/16/2012S33510042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021356s042,022577s002lbl.pdf 8/17/2012
AP08/16/2012S33515042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021356Orig1s042,022577Orig1s002ltr.pdf 8/20/2012
AP03/12/2013SCM       
AP07/24/2013SE536611046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021356Orig1s046,022577Orig1s003ltr.pdf 7/26/2013
AP07/24/2013SE536659046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021356s046,022577s003lbl.pdf 7/30/2013
AP04/2/2013SLR35633047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021356Orig1s047,022577Orig1s004ltr.pdf 4/3/2013
AP04/2/2013SLR35659047   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021356s047,022577s004lbl.pdf 4/9/2013
AP010/23/2013SLR37555048   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021356Orig1s048,022577Orig1s006ltr.pdf 10/25/2013
AP010/23/2013SLR37576048   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021356s048,022577s006lbl.pdf 10/25/2013
AP05/29/2015SE842960049   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021356Orig1s049,022577Orig1s007ltr.pdf 6/2/2015
AP05/29/2015SE842996049   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021356s049,022577s007lbl.pdf 6/4/2015
AP011/18/2015SCM       
AP02/16/2016SLR45187052   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021356Orig1s052,022577Orig1s009ltr.pdf 2/18/2016
AP02/16/2016SLR45199052   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021356s052,022577s009lbl.pdf 2/18/2016
AP03/10/2016SCM       




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