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FDA Drug Application 020972 by BRISTOL MYERS SQUIBB

Application Number020972
Application Type New Drug Application
Sponsor ApplicantBRISTOL MYERS SQUIBB
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
AP09/17/1998N835000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20972ltr.pdf 9/17/1998
AP09/17/1998N836000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20972.cfm 9/17/1998
AP09/17/1998N837000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20972lbl.pdf 9/17/1998
AP02/9/2000SE71321001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20972S7LBL.PDF 2/9/2000
AP02/9/2000SE77870001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-972_S001_Sustiva.cfm 3/10/2004
AP02/9/2000SE79438001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-972_s001_Sustiva_Approv.pdf 6/18/2004
AP08/27/1999SCE       
AP05/31/2000SCM       
AP04/18/2000SCS       
AP05/31/2000SCM       
AP011/14/2000SLR       
AP03/1/2002SLR3339007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20972s7ltr.pdf 3/1/2002
AP04/12/2001SCS       
AP05/16/2001SCM       
AP011/21/2001SCM       
AP010/16/2001SLR5486013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20972s13lbl.pdf 4/25/2003
AP02/28/2002SCM17307014   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020972_S014_SUSTIVA.pdf 7/18/2007
AP01/29/2003SLR4188016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20972slr016ltr.pdf 1/29/2003
AP01/29/2003SLR4189016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20972slr016_Sustiva_lbl.pdf 1/29/2003
AP09/20/2002SLR3334017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20972SLR017,%2021360slr001ltr.pdf 9/20/2002
AP06/10/2003SLR5967018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20972slr018,21360slr003ltr.pdf 6/22/2003
AP06/10/2003SLR5991018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20972slr018,21360slr003_sustiva_lbl.pdf 6/22/2003
AP06/10/2003SLR5969019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20972slr019,21360slr004ltr.pdf 6/22/2003
AP06/10/2003SLR5990019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20972slr019,21360slr004_sustiva_lbl.pdf 6/22/2003
AP011/13/2003SLR6988021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20972slr021,21360slr005ltr.pdf 11/26/2003
AP011/13/2003SLR7005021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20972slr021,21360slr005_sustiva_lbl.pdf 12/1/2003
AP08/13/2004SE810044022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20972s022,21360s006ltr.pdf 8/25/2004
AP08/13/2004SE810076022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20972s022,21360s006lbl.pdf 8/25/2004
AP08/13/2004SE817308022   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020972_S022_SUSTIVA.pdf 7/18/2007
AP010/22/2004SLR10488024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20972s024,21360s009ltr.pdf 10/29/2004
AP010/22/2004SLR10517024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20972s024,21360s009lbl.pdf 11/1/2004
AP04/20/2005SLR11498026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020972s026,021360s013ltr.pdf 4/28/2005
AP04/20/2005SLR11518026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020972s026,021360s013lbl.pdf 4/28/2005
AP03/28/2006SLR13844027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021360s014,020972s027ltr.pdf 4/5/2006
AP03/28/2006SLR15774027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020972s027lbl.pdf 2/5/2007
AP03/28/2006SLR17310027   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020972_S027_SUSTIVA.pdf 7/20/2007
AP01/24/2007SLR15728029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020972s029,021360s016lbl.pdf 2/2/2007
AP01/24/2007SLR15745029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020972s029, 021360s016ltr.pdf 2/2/2007
AP08/18/2008SLR20646030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020972s030,021360s017ltr.pdf 8/20/2008
AP08/18/2008SLR20671030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020972s030,021360s019lbl.pdf 8/26/2008
AP03/10/2009SLR21987031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020972s031,021360s018ltr.pdf 3/12/2009
AP03/10/2009SLR22309031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021360s018,020972s031lbl.pdf 4/23/2009
AP09/23/2009SLR23506033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020972s033,021360s021lbl.pdf 10/1/2009
AP09/23/2009SLR23798033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020972s033,021360s021ltr.pdf 11/10/2009
AP03/31/2010SLR25193035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020972s035,021360s023lbl.pdf 4/4/2010
AP03/31/2010SLR25213035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020972s035,021360s023ltr.pdf 4/5/2010
AP011/30/2010SLR27114036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020972s036lbl.pdf 11/29/2010
AP011/30/2010SLR27150036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020972s036,021360s024ltr.pdf 12/3/2010
AP09/26/2011SLR30089038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020972s038lbl.pdf 9/26/2011
AP09/26/2011SLR30143038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020972s038,021360s026ltr.pdf 9/29/2011
AP012/19/2011SLR31082040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020972s040lbl.pdf 12/19/2011
AP012/19/2011SLR31149040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020972s040,021360s028ltr.pdf 12/21/2011
AP06/22/2012SLR32999041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020972s041,021360s029ltr.pdf 6/26/2012
AP06/22/2012SLR33028041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020972s041,021360s029lbl.pdf 6/26/2012
AP08/10/2012SLR33444042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020972Orig1s042,021360Orig1s030ltr.pdf 8/15/2012
AP08/10/2012SLR33469042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020972s042,021360s030lbl.pdf 8/15/2012
AP05/2/2013S35953043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020972Orig1s043,021360Orig1s031ltr.pdf 5/7/2013
AP05/2/2013S36089043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020972s043,021360s031lbl.pdf 5/21/2013
AP01/15/2014SCM       
AP01/22/2014SCM       
AP05/23/2014SLR39357046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020972Orig1s046,021360Orig1s035ltr.pdf 5/27/2014
AP05/23/2014SLR39377046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020972s046,021360s035lbl.pdf 5/28/2014
AP08/14/2014SCM       
AP03/27/2015SLR42348048   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021360Orig1s037,020972Orig1s048ltr.pdf 4/1/2015
AP03/27/2015SLR42392048   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021360s037,020972s048lbl.pdf 4/2/2015
AP03/30/2016SLR45566049   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020972Orig1s049,021360Orig1s038ltr.pdf 4/1/2016
AP03/30/2016SLR45567049   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020972s049-021360s038lbl.pdf 4/1/2016
AP06/3/2016SCM       
AP08/31/2016SLR46950051   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021360Orig1s039,020972Orig1s051ltr.pdf 9/2/2016
AP08/31/2016SLR46962051   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021360s039,020972s051lbl.pdf 9/2/2016
AP010/12/2016SLR47359053   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021360Orig1s041,020972Orig1s053ltr.pdf 10/14/2016
AP010/12/2016SLR47380053   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020972s053,021360s041lbl.pdf 10/17/2016




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