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FDA Drug Application 021360 by BRISTOL MYERS SQUIBB

Application Number	021360
Application Type	New Drug Application
Sponsor Applicant	BRISTOL MYERS SQUIBB
Most Recent Label Available Flag
Current Patent Flag
Action Type	Approval
Chemical Type	New formulation
Therapeutic Potential	Standard
Orphan Code

Action Type	Action Date	Document Type	Application Document ID	Sequence Number	Document URL	Document Date
AP	2/1/2002	N	3336	000	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21360ltr.pdf	2/1/2002
AP	2/1/2002	N	3337	000	http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21360lbl.pdf	2/1/2002
AP	2/1/2002	N	3338	000	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-360_EfavirenzSustiva.cfm	5/15/2002
AP	9/20/2002	SLR	3335	001	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20972SLR017,%2021360slr001ltr.pdf	9/20/2002
AP	6/10/2003	SLR	5968	003	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20972slr018,21360slr003ltr.pdf	6/22/2003
AP	6/10/2003	SLR	5992	003	http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20972slr018,21360slr003_sustiva_lbl.pdf	6/22/2003
AP	6/10/2003	SLR	5970	004	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20972slr019,21360slr004ltr.pdf	6/22/2003
AP	6/10/2003	SLR	5993	004	http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20972slr018,21360slr003_sustiva_lbl.pdf	6/22/2003
AP	11/13/2003	SLR	6989	005	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20972slr021,21360slr005ltr.pdf	11/26/2003
AP	11/13/2003	SLR	7006	005	http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20972slr021,21360slr005_sustiva_lbl.pdf	12/1/2003
AP	8/13/2004	SE8	10045	006	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20972s022,21360s006ltr.pdf	8/25/2004
AP	8/13/2004	SE8	10077	006	http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20972s022,21360s006lbl.pdf	8/25/2004
AP	8/13/2004	SE8	17309	006	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021360_S006_SUSTIVA.pdf	7/20/2007
AP	10/22/2004	SLR	10489	009	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20972s024,21360s009ltr.pdf	10/29/2004
AP	10/22/2004	SLR	10518	009	http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20972s024,21360s009lbl.pdf	11/1/2004
AP	4/20/2005	SLR	11499	013	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020972s026,021360s013ltr.pdf	4/28/2005
AP	4/20/2005	SLR	11519	013	http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020972s026,021360s013lbl.pdf	4/28/2005
AP	3/28/2006	SLR	15772	014	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021360s014,020972s027ltr.pdf	2/5/2007
AP	3/28/2006	SLR	15773	014	http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021360s014lbl.pdf	2/5/2007
AP	3/28/2006	SLR	17311	014	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021360_S014_SUSTIVA.pdf	7/20/2007
AP	1/24/2007	SLR	15727	016	http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020972s029,021360s016lbl.pdf	2/2/2007
AP	1/24/2007	SLR	15744	016	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020972s029, 021360s016ltr.pdf	2/2/2007
AP	8/18/2008	SLR	20647	017	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020972s030,021360s017ltr.pdf	8/20/2008
AP	3/10/2009	SLR	21988	018	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020972s031,021360s018ltr.pdf	3/12/2009
AP	3/10/2009	SLR	22308	018	http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021360s018,020972s031lbl.pdf	4/23/2009
AP	8/18/2008	SLR	20672	019	http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020972s030,021360s019lbl.pdf	8/26/2008
AP	9/23/2009	SLR	23505	021	http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020972s033,021360s021lbl.pdf	10/1/2009
AP	9/23/2009	SLR	23799	021	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020972s033,021360s021ltr.pdf	11/10/2009
AP	3/31/2010	SLR	25192	023	http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020972s035,021360s023lbl.pdf	4/4/2010
AP	3/31/2010	SLR	25214	023	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020972s035,021360s023ltr.pdf	4/5/2010
AP	11/30/2010	SLR	27113	024	http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021360s024lbl.pdf	11/29/2010
AP	11/30/2010	SLR	27151	024	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020972s036,021360s024ltr.pdf	12/3/2010
AP	9/26/2011	SLR	30088	026	http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021360s026lbl.pdf	9/27/2011
AP	9/26/2011	SLR	30144	026	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020972s038,021360s026ltr.pdf	9/29/2011
AP	12/19/2011	SLR	31081	028	http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021360s028lbl.pdf	12/19/2011
AP	12/19/2011	SLR	31150	028	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020972s040,021360s028ltr.pdf	12/21/2011
AP	6/22/2012	SLR	33000	029	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020972s041,021360s029ltr.pdf	6/26/2012
AP	6/22/2012	SLR	33027	029	http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020972s041,021360s029lbl.pdf	6/26/2012
AP	8/10/2012	SLR	33445	030	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020972Orig1s042,021360Orig1s030ltr.pdf	8/15/2012
AP	8/10/2012	SLR	33470	030	http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020972s042,021360s030lbl.pdf	8/15/2012
AP	5/2/2013	S	35941	031	http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020972s043,021360s031lbl.pdf	5/3/2013
AP	5/2/2013	S	35954	031	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020972Orig1s043,021360Orig1s031ltr.pdf	5/7/2013
AP	7/9/2013	SCM
AP	1/22/2014	SCM
AP	5/23/2014	SLR	39358	035	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020972Orig1s046,021360Orig1s035ltr.pdf	5/27/2014
AP	5/23/2014	SLR	39376	035	http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020972s046,021360s035lbl.pdf	5/28/2014
AP	8/14/2014	SCM
AP	3/27/2015	SLR	42347	037	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021360Orig1s037,020972Orig1s048ltr.pdf	4/1/2015
AP	3/27/2015	SLR	42393	037	http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021360s037,020972s048lbl.pdf	4/2/2015
AP	3/31/2016	SLR	45565	038	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020972Orig1s049,021360Orig1s038ltr.pdf	4/1/2016
AP	3/31/2016	SLR	45568	038	http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020972s049-021360s038lbl.pdf	4/1/2016
AP	8/31/2016	SLR	46949	039	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021360Orig1s039,020972Orig1s051ltr.pdf	9/2/2016
AP	8/31/2016	SLR	46961	039	http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021360s039,020972s051lbl.pdf	9/2/2016
AP	10/12/2016	SLR	47358	041	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021360Orig1s041,020972Orig1s053ltr.pdf	10/14/2016
AP	10/12/2016	SLR	47381	041	http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020972s053,021360s041lbl.pdf	10/17/2016

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