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FDA Drug Application 021526 by GILEAD

Application Number021526
Application Type New Drug Application
Sponsor ApplicantGILEAD
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP01/27/2006N13590000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021526s000lbl.pdf 2/7/2006
AP01/27/2006N13612000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021526s000ltr.pdf 2/8/2006
AP01/27/2006N13872000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021526_s000_Ranexa.cfm 4/6/2006
AP012/17/2007SLR18687002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021526s002lbl.pdf 12/27/2007
AP012/17/2007SLR18829002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021526s002ltr.pdf 1/9/2008
AP011/5/2008SE121140004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021526s004ltr.pdf 11/6/2008
AP011/5/2008SE121175004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021526s004lbl.pdf 11/7/2008
AP011/5/2008SE141633004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021526Orig1s004TOC.cfm 1/16/2015
AP03/26/2009SCM22118007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021526s007lbl.pdf 3/26/2009
AP03/26/2009SCM22133007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021526s007ltr.pdf 3/27/2009
AP03/26/2009SCM40133007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021526Orig1s007.pdf 8/5/2014
AP09/23/2010SLR26551012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021526s012ltr.pdf 9/28/2010
AP09/23/2010SLR26573012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021526s012lbl.pdf 9/29/2010
AP07/11/2011SLR29470014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021526s014lbl.pdf 7/11/2011
AP07/11/2011SLR29508014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021526s014ltr.pdf 7/13/2011
AP012/21/2011SLR31225018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021526s018lbl.pdf 12/23/2011
AP012/21/2011SLR31279018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021526s018ltr.pdf 12/28/2011
AP07/25/2012SLR33280022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021526s022lbl.pdf 7/26/2012
AP07/25/2012SLR33284022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021526Orig1s022ltr.pdf 7/30/2012
AP011/12/2013SLR37812025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021526s025lbl.pdf 11/14/2013
AP011/12/2013SLR37821025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021526Orig1s025ltr.pdf 11/15/2013
AP012/19/2013SLR38127026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021526Orig1s026ltr.pdf 12/20/2013
AP012/19/2013SLR38145026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021526s026lbl.pdf 12/23/2013
AP01/17/2014SCM       
AP012/15/2015SLR44787028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021526Orig1s028ltr.pdf 12/16/2015
AP012/15/2015SLR44801028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021526s028lbl.pdf 12/17/2015
AP01/6/2016S44938029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021526Orig1s029ltr.pdf 1/7/2016
AP01/6/2016S44941029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021526s029lbl.pdf 1/7/2016
AP011/10/2015SCM       
AP04/22/2016SCM       




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