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FDA Drug Application 021449 by GILEAD

Application Number021449
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 Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP09/20/2002N2215000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21449ltr.pdf 9/20/2002
AP09/20/2002N2216000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21449lbl.pdf 9/20/2002
AP09/20/2002N9055000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-449_Hepsera.cfm 6/7/2004
AP08/19/2004SE810035003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21449s003ltr.pdf 8/25/2004
AP08/19/2004SE810080003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21449s003lbl.pdf 8/25/2004
AP04/28/2006SE814042005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021449s005LTR.pdf 5/2/2006
AP04/28/2006SE814048005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021449s005lbl.pdf 5/2/2006
AP010/18/2006SE815157006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021449s006lbl.pdf 10/23/2006
AP010/18/2006SE815174006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021449s006ltr.pdf 10/23/2006
AP09/20/2006SLR14932009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021449s009lbl.pdf 9/21/2006
AP09/20/2006SLR14956009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021449s009ltr.pdf 9/25/2006
AP012/19/2007SE518676011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021449s011lbl.pdf 12/27/2007
AP012/19/2007SE518813011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021449s011ltr.pdf 1/9/2008
AP05/27/2008SLR       
AP010/16/2009SLR23657016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021449s016lbl.pdf 10/21/2009
AP010/16/2009SLR24133016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021449s016ltr.pdf 11/25/2009
AP02/29/2012SLR31979018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021449s018lbl.pdf 3/1/2012
AP02/29/2012SLR31985018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021449s018ltr.pdf 3/2/2012
AP011/29/2012SLR34510020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021449Orig1s020ltr.pdf 11/30/2012
AP011/29/2012SLR34511020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021449s020lbl.pdf 11/30/2012
AP010/4/2013SCM       
AP02/20/2014SCM       




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