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FDA Drug Application 021896 by GILEAD

Application Number021896
Application Type New Drug Application
Sponsor ApplicantGILEAD
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP09/28/2005N17297000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021896s000TOC.cfm 7/18/2007
AP09/28/2005N12828000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021896lbl.pdf 9/30/2005
AP09/28/2005N12933000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021896ltr.pdf 10/20/2005
AP012/22/2006SE515507001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021896s001,021500s007lbl.pdf 12/28/2006
AP012/22/2006SE515610001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021896s001,021500s007ltr.pdf 1/8/2007
AP04/4/2008SLR19626004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021500s010, 021896s004ltr.pdf 4/9/2008
AP04/4/2008SLR19669004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021500s010,021896s004lbl.pdf 4/16/2008
AP05/16/2008SE819857005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021500s011,021896s005ltr.pdf 5/21/2008
AP011/18/2011SLR30737015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021500s018,021896s015ltr.pdf 11/22/2011
AP011/18/2011SLR30789015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021500s018,021896s015lbl.pdf 11/29/2011
AP07/23/2012SLR33264016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021896s016lbl.pdf 7/24/2012
AP07/23/2012SLR33272016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021500Orig1s019,021896Orig1s016ltr.pdf 7/25/2012
AP04/2/2013SLR35631018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021500Orig1s021,021896Orig1s018ltr.pdf 4/3/2013
AP04/2/2013SLR35656018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021500s021,021896s018lbl.pdf 4/9/2013
AP011/8/2013SCM       
AP02/20/2014SCM       




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