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FDA Drug Application 009218 by BRISTOL MYERS SQUIBB

Application Number	009218
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	Standard
Orphan Code

Action Type	Action Date	Document Type	Application Document ID	Sequence Number	Document URL	Document Date
AP	6/8/1954	N	15834	000	http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088578.pdf	2/20/2007
AP	8/21/1975	SLR
AP	9/27/1976	SLR
AP	2/11/1977	SCF
AP	12/5/1977	SCS
AP	4/14/1978	SCS
AP	7/6/1979	SCP
AP	4/30/1980	SCP
AP	2/1/1980	SCS
AP	12/29/1980	SCP
AP	7/6/1987	SPD
AP	1/17/1985	SLR
AP	2/25/1985	SLR
AP	5/13/1985	SLR
AP	7/8/1986	SLR
AP	7/6/1987	SLR
AP	7/1/1988	SCF
AP	3/1/1990	SCF
AP	3/1/1990	SLR
AP	3/1/1990	SLR
AP	4/25/1990	SLR
AP	5/10/1991	SCM
AP	4/11/1991	SLR
AP	4/11/1991	SLR
AP	12/15/1993	SCM
AP	8/24/1993	SCF
AP	8/20/1992	SLR
AP	2/1/1993	SLR
AP	6/8/1993	SLR
AP	3/31/1994	SE1
AP	8/6/1993	SLR
AP	4/28/1995	SE1
AP	2/7/1995	SCF
AP	2/7/1995	SCM
AP	3/8/1995	SCS
AP	9/7/1995	SLR
AP	11/18/1996	SCF
AP	11/8/1996	SCM
AP	9/5/1996	SLR
AP	6/1/1998	SLR	2604	086	http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/009218a.pdf	6/1/1998
AP	11/23/1998	SCP
AP	10/29/1997	SCS
AP	4/16/1998	SCP
AP	6/1/1998	SLR	2605	090	http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/009218a.pdf	6/1/1998
AP	6/1/1998	SLR	2606	091	http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/009218a.pdf	6/1/1998
AP	12/23/1998	SCM
AP	3/31/1999	SCM
AP	12/2/1999	SCM
AP	7/9/1999	SLR
AP	2/17/2000	SLR	2603	097	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/09218S097_Coumadin.pdf	2/17/2000
AP	5/3/2002	SLR	2602	098	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/09218s098ltr.pdf	5/3/2002
AP	5/3/2002	SLR	2601	099	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/09218s099ltr.pdf	5/3/2002
AP	9/2/2005	SLR	12715	101	http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/009218s101lbl.pdf	9/7/2005
AP	9/2/2005	SLR	12716	101	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/009218s101ltr.pdf	9/7/2005
AP	9/2/2005	SLR	27028	101	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/009218_s101_coumadin.pdf	9/2/2005
AP	10/4/2006	SLR	15051	102	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/009218s102LTR.pdf	10/5/2006
AP	10/4/2006	SLR	15058	102	http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/009218s102lbl.pdf	10/5/2006
AP	8/16/2007	SLR	17635	105	http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/009218s105lblv2.pdf	8/16/2007
AP	8/16/2007	SLR	17651	105	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/009218s105ltr.pdf	8/17/2007
AP	10/4/2011	SLR	30219	107	http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/009218s107lbl.pdf	10/5/2011
AP	10/4/2011	SLR	30221	107	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/009218s107ltr.pdf	10/5/2011
AP	1/22/2010	SLR	24600	108	http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/009218s108lbl.pdf	1/24/2010
AP	1/22/2010	SLR	24654	108	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/009218s108ltr.pdf	1/28/2010
AP	3/25/2013	SCM
AP	12/2/2014	SCM
AP	10/28/2015	SLR	44331	115	http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/009218s115lbl.pdf	10/29/2015
AP	10/28/2015	SLR	44336	115	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/009218Orig1s115ltr.pdf	10/30/2015
AP	9/8/2016	SLR	47018	116	http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/009218s116lbl.pdf	9/9/2016
AP	9/8/2016	SLR	47023	116	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/009218Orig1s116ltr.pdf	9/12/2016

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