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FDA Drug Application 021360 by BRISTOL MYERS SQUIBB

Application Number021360
Application Type New Drug Application
Sponsor ApplicantBRISTOL MYERS SQUIBB
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP02/1/2002N3336000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21360ltr.pdf 2/1/2002
AP02/1/2002N3337000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21360lbl.pdf 2/1/2002
AP02/1/2002N3338000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-360_EfavirenzSustiva.cfm 5/15/2002
AP09/20/2002SLR3335001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20972SLR017,%2021360slr001ltr.pdf 9/20/2002
AP06/10/2003SLR5968003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20972slr018,21360slr003ltr.pdf 6/22/2003
AP06/10/2003SLR5992003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20972slr018,21360slr003_sustiva_lbl.pdf 6/22/2003
AP06/10/2003SLR5970004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20972slr019,21360slr004ltr.pdf 6/22/2003
AP06/10/2003SLR5993004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20972slr018,21360slr003_sustiva_lbl.pdf 6/22/2003
AP011/13/2003SLR6989005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20972slr021,21360slr005ltr.pdf 11/26/2003
AP011/13/2003SLR7006005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20972slr021,21360slr005_sustiva_lbl.pdf 12/1/2003
AP08/13/2004SE810045006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20972s022,21360s006ltr.pdf 8/25/2004
AP08/13/2004SE810077006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20972s022,21360s006lbl.pdf 8/25/2004
AP08/13/2004SE817309006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021360_S006_SUSTIVA.pdf 7/20/2007
AP010/22/2004SLR10489009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20972s024,21360s009ltr.pdf 10/29/2004
AP010/22/2004SLR10518009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20972s024,21360s009lbl.pdf 11/1/2004
AP04/20/2005SLR11499013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020972s026,021360s013ltr.pdf 4/28/2005
AP04/20/2005SLR11519013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020972s026,021360s013lbl.pdf 4/28/2005
AP03/28/2006SLR15772014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021360s014,020972s027ltr.pdf 2/5/2007
AP03/28/2006SLR15773014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021360s014lbl.pdf 2/5/2007
AP03/28/2006SLR17311014   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021360_S014_SUSTIVA.pdf 7/20/2007
AP01/24/2007SLR15727016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020972s029,021360s016lbl.pdf 2/2/2007
AP01/24/2007SLR15744016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020972s029, 021360s016ltr.pdf 2/2/2007
AP08/18/2008SLR20647017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020972s030,021360s017ltr.pdf 8/20/2008
AP03/10/2009SLR21988018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020972s031,021360s018ltr.pdf 3/12/2009
AP03/10/2009SLR22308018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021360s018,020972s031lbl.pdf 4/23/2009
AP08/18/2008SLR20672019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020972s030,021360s019lbl.pdf 8/26/2008
AP09/23/2009SLR23505021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020972s033,021360s021lbl.pdf 10/1/2009
AP09/23/2009SLR23799021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020972s033,021360s021ltr.pdf 11/10/2009
AP03/31/2010SLR25192023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020972s035,021360s023lbl.pdf 4/4/2010
AP03/31/2010SLR25214023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020972s035,021360s023ltr.pdf 4/5/2010
AP011/30/2010SLR27113024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021360s024lbl.pdf 11/29/2010
AP011/30/2010SLR27151024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020972s036,021360s024ltr.pdf 12/3/2010
AP09/26/2011SLR30088026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021360s026lbl.pdf 9/27/2011
AP09/26/2011SLR30144026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020972s038,021360s026ltr.pdf 9/29/2011
AP012/19/2011SLR31081028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021360s028lbl.pdf 12/19/2011
AP012/19/2011SLR31150028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020972s040,021360s028ltr.pdf 12/21/2011
AP06/22/2012SLR33000029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020972s041,021360s029ltr.pdf 6/26/2012
AP06/22/2012SLR33027029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020972s041,021360s029lbl.pdf 6/26/2012
AP08/10/2012SLR33445030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020972Orig1s042,021360Orig1s030ltr.pdf 8/15/2012
AP08/10/2012SLR33470030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020972s042,021360s030lbl.pdf 8/15/2012
AP05/2/2013S35941031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020972s043,021360s031lbl.pdf 5/3/2013
AP05/2/2013S35954031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020972Orig1s043,021360Orig1s031ltr.pdf 5/7/2013
AP07/9/2013SCM       
AP01/22/2014SCM       
AP05/23/2014SLR39358035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020972Orig1s046,021360Orig1s035ltr.pdf 5/27/2014
AP05/23/2014SLR39376035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020972s046,021360s035lbl.pdf 5/28/2014
AP08/14/2014SCM       
AP03/27/2015SLR42347037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021360Orig1s037,020972Orig1s048ltr.pdf 4/1/2015
AP03/27/2015SLR42393037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021360s037,020972s048lbl.pdf 4/2/2015
AP03/31/2016SLR45565038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020972Orig1s049,021360Orig1s038ltr.pdf 4/1/2016
AP03/31/2016SLR45568038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020972s049-021360s038lbl.pdf 4/1/2016
AP08/31/2016SLR46949039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021360Orig1s039,020972Orig1s051ltr.pdf 9/2/2016
AP08/31/2016SLR46961039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021360s039,020972s051lbl.pdf 9/2/2016
AP010/12/2016SLR47358041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021360Orig1s041,020972Orig1s053ltr.pdf 10/14/2016
AP010/12/2016SLR47381041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020972s053,021360s041lbl.pdf 10/17/2016




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