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FDA Drug Application 018731 by BRISTOL MYERS SQUIBB

Application Number	018731
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	9/29/1986	N
AP	12/16/1986	SCP
AP	12/16/1986	SCP
AP	4/23/1987	SCM
AP	7/25/1989	SCP
AP	7/25/1989	SLR
AP	8/10/1987	SLR
AP	6/23/1988	SCM
AP	11/2/1988	SLR
AP	3/2/1989	SCS
AP	3/2/1989	SCS
AP	10/13/1988	SCP
AP	4/28/1989	SCM
AP	7/31/1991	SLR
AP	1/26/1990	SCM
AP	3/2/1998	SLR
AP	1/26/1990	SCM
AP	10/5/1990	SCS
AP	4/22/1996	SCF
AP	9/23/1993	SLR
AP	4/22/1996	SLR
AP	3/20/1996	SCS
AP	6/19/1996	SCM
AP	4/22/1996	SE2
AP	12/30/1996	SCP
AP	5/20/1998	SLR
AP	5/20/1998	SLR
AP	4/3/1998	SCP
AP	6/19/1998	SCM
AP	1/27/1999	SCM
AP	5/3/2001	SLR	5229	039	http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18731s39s45lbl.pdf	4/14/2003
AP	7/27/1999	SCP
AP	11/1/1999	SCM
AP	4/25/2000	SCP
AP	7/19/2001	SE5	3818	043	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/18731s43ltr.pdf	7/19/2001
AP	7/19/2001	SE5	3819	043	http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18731s43lbl.pdf	7/19/2001
AP	7/19/2001	SE5	8346	043	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/18-731S043_review.pdf	4/14/2004
AP	5/3/2001	SLR	5228	045	http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18731s39s45lbl.pdf	4/14/2003
AP	2/7/2002	SLR	3817	046	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18731s46ltr.pdf	2/7/2002
AP	9/21/2007	SLR	17952	048	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018731s048ltr.pdf	9/25/2007
AP	9/21/2007	SLR	18024	048	http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018731s048lbl.pdf	9/26/2007
AP	11/22/2010	SLR	27011	051	http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018731s051lbl.pdf	11/22/2010
AP	11/22/2010	SLR	27077	051	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018731s051ltr.pdf	11/30/2010

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