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FDA Drug Application 016295 by BRISTOL MYERS SQUIBB

Application Number	016295
Application Type	New Drug Application
Sponsor Applicant	BRISTOL 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 Type	Action Date	Document Type	Application Document ID	Sequence Number	Document URL	Document Date
AP	12/7/1967	N
AP	5/3/1977	SCS
AP	2/19/1980	SCS
AP	9/24/1996	SLR
AP	3/19/1987	SCS
AP	7/16/1985	SCM
AP	3/19/1987	SCS
AP	5/10/1988	SCF
AP	8/25/1988	SCS
AP	9/5/1995	SCS
AP	7/31/1992	SCS
AP	3/9/1993	SCF
AP	9/24/1996	SLR
AP	10/15/1996	SCS
AP	11/25/1996	SCP
AP	8/11/1999	SLR
AP	4/7/1997	SCM
AP	5/23/1997	SCM
AP	2/25/1998	SE1
AP	2/25/1998	SCS
AP	11/10/1998	SCM
AP	1/12/2000	SLR
AP	4/4/2001	SLR	2270	034	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/16295S34ltr.pdf	4/4/2001
AP	2/20/2001	SLR
AP	6/26/2003	SE2	6031	036	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/16295se2-036ltr.pdf	7/6/2003
AP	6/26/2003	SE2	6081	036	http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/16295se2-036_droxia_lbl.pdf	7/8/2003
AP	6/26/2003	SE2	8335	036	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/16-295S036_Droxia.cfm	4/14/2004
AP	2/19/2004	SLR	7775	037	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/16295slr037ltr.pdf	3/2/2004
AP	2/19/2004	SLR	8185	037	http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/16295slr037_hydrea_lbl.pdf	4/5/2004
AP	9/19/2006	SLR	14905	039	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/016295s039, 016295s036ltr.pdf	9/20/2006
AP	9/19/2006	SLR	14917	039	http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/016295s039s036lbl.pdf	9/20/2006
AP	5/7/2010	SLR	25523	040	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/016295s040ltr.pdf	5/12/2010
AP	5/7/2010	SLR	25571	040	http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/016295s040lbl.pdf	5/17/2010
AP	1/26/2012	SLR	31579	041	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/016295s041,s042ltr.pdf	1/30/2012
AP	1/26/2012	SLR	31615	041	http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016295s041s042lbl.pdf	1/31/2012
AP	1/26/2012	SLR	31580	042	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/016295s041,s042ltr.pdf	1/30/2012
AP	1/26/2012	SLR	31616	042	http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016295s041s042lbl.pdf	1/31/2012
AP	7/16/2015	SLR	43405	045	http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/016295s045lbl.pdf	7/17/2015
AP	7/16/2015	SLR	43407	045	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/016295Orig1s045ltr.pdf	7/20/2015
AP	7/16/2015	SLR	43406	046	http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/016295s046lbl.pdf	7/17/2015
AP	7/16/2015	SLR	43408	046	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/016295Orig1s046ltr.pdf	7/20/2015
AP	3/23/2016	SLR	45506	047	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/016295Orig1s047,s048ltr.pdf	3/25/2016
AP	3/23/2016	SLR	45509	047	http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016295Orig1s047,s048Lbl.pdf	3/28/2016
AP	3/23/2016	SLR	45510	048	http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016295Orig1s047,s048Lbl.pdf	3/28/2016

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