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FDA Drug Application 021937 by GILEAD

Application Number021937
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
AP07/12/2006N14440000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021937lbl.pdf 7/12/2006
AP07/12/2006N14512000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021937s000ltr.pdf 7/21/2006
AP07/12/2006N15455000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021937TOC2.cfm 12/13/2006
AP02/15/2008SLR19238006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021937s006ltr.pdf 2/20/2008
AP02/15/2008SLR19275006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021937s006lbl.pdf 2/25/2008
AP02/28/2008SLR19351007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021937s007ltr.pdf 3/4/2008
AP02/28/2008SLR19374007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021937s007lbl.pdf 3/5/2008
AP06/6/2008SE819970009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021937s009ltr.pdf 6/9/2008
AP06/6/2008SE819998009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021937s009lbl.pdf 6/12/2008
AP010/18/2008SCP21067011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021937s011ltr.pdf 10/23/2008
AP01/7/2010SE824474012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021937s012lbl.pdf 1/8/2010
AP01/7/2010SE824522012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021937s012ltr.pdf 1/15/2010
AP08/6/2010SLR26179019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021937s019lbl.pdf 8/10/2010
AP08/6/2010SLR26201019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021937s019ltr.pdf 8/11/2010
AP09/16/2011SLR30036023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021937s023ltr.pdf 9/20/2011
AP09/16/2011SLR30050023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021937s023lbl.pdf 9/20/2011
AP06/14/2012SLR32917025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021937s025ltr.pdf 6/18/2012
AP06/14/2012SLR32926025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021937s025lbl.pdf 6/18/2012
AP04/17/2013SLR35759027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021937s027lbl.pdf 4/19/2013
AP04/17/2013SLR35763027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021937Orig1s027ltr.pdf 4/23/2013
AP011/8/2013SCM       
AP010/23/2013SLR37553031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021937Orig1s031ltr.pdf 10/25/2013
AP010/23/2013SLR37571031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021937s031lbl.pdf 10/25/2013
AP07/11/2014SCM       
AP011/26/2014SCM       
AP01/23/2015SLR41678034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021937Orig1s034ltr.pdf 1/26/2015
AP01/23/2015SLR41727034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021937s034lbl.pdf 1/29/2015
AP01/12/2015SCM       
AP011/20/2015SLR44558037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021937Orig1s037ltr.pdf 11/23/2015
AP011/20/2015SLR44656037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021937s037lbl.pdf 12/3/2015
AP02/11/2016SLR45163039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021937Orig1s039ltr.pdf 2/12/2016
AP02/11/2016SLR45185039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021937s039lbl.pdf 2/18/2016




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