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FDA Drug Application 021500 by GILEAD

Application Number021500
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
AP07/2/2003N6090000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21500_emtriva_lbl.pdf 7/8/2003
AP07/2/2003N6092000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21500ltr.pdf 7/8/2003
AP07/2/2003N6613000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021500_emtriva_toc.cfm 9/9/2003
AP06/13/2005SLR11803002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021500s002ltr.pdf 6/14/2005
AP012/2/2005SLR13239003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021500s003lbl.pdf 12/13/2005
AP012/2/2005SLR13245003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021500s003ltr.pdf 12/13/2005
AP012/22/2006SLR15506007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021896s001,021500s007lbl.pdf 12/28/2006
AP012/22/2006SLR15609007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021896s001,021500s007ltr.pdf 1/8/2007
AP04/4/2008SLR19625010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021500s010, 021896s004ltr.pdf 4/9/2008
AP04/4/2008SLR19668010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021500s010,021896s004lbl.pdf 4/16/2008
AP05/16/2008SE819856011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021500s011,021896s005ltr.pdf 5/21/2008
AP011/18/2011SLR30736018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021500s018,021896s015ltr.pdf 11/22/2011
AP011/18/2011SLR30790018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021500s018,021896s015lbl.pdf 11/29/2011
AP07/23/2012SLR33265019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021500s019lbl.pdf 7/23/2012
AP07/23/2012SLR33271019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021500Orig1s019,021896Orig1s016ltr.pdf 7/25/2012
AP04/2/2013SLR35630021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021500Orig1s021,021896Orig1s018ltr.pdf 4/3/2013
AP04/2/2013SLR35657021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021500s021,021896s018lbl.pdf 4/9/2013
AP011/8/2013SCM       
AP03/25/2014SCM       




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