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Back to FDA Applications sponsored by BRISTOL MYERS SQUIBB
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
Duplicate Counter
Action Date
Document Type
Application Document ID
Sequence Number
Document Title
Document URL
Document Date
AP
0
9/29/1986
N
AP
0
12/16/1986
SCP
AP
0
12/16/1986
SCP
AP
0
4/23/1987
SCM
AP
0
7/25/1989
SCP
AP
0
7/25/1989
SLR
AP
0
8/10/1987
SLR
AP
0
6/23/1988
SCM
AP
0
11/2/1988
SLR
AP
0
3/2/1989
SCS
AP
0
3/2/1989
SCS
AP
0
10/13/1988
SCP
AP
0
4/28/1989
SCM
AP
0
7/31/1991
SLR
AP
0
1/26/1990
SCM
AP
0
3/2/1998
SLR
AP
0
1/26/1990
SCM
AP
0
10/5/1990
SCS
AP
0
4/22/1996
SCF
AP
0
9/23/1993
SLR
AP
0
4/22/1996
SLR
AP
0
3/20/1996
SCS
AP
0
6/19/1996
SCM
AP
0
4/22/1996
SE2
AP
0
12/30/1996
SCP
AP
0
5/20/1998
SLR
AP
0
5/20/1998
SLR
AP
0
4/3/1998
SCP
AP
0
6/19/1998
SCM
AP
0
1/27/1999
SCM
AP
0
5/3/2001
SLR
5229
039
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18731s39s45lbl.pdf
4/14/2003
AP
0
7/27/1999
SCP
AP
0
11/1/1999
SCM
AP
0
4/25/2000
SCP
AP
0
7/19/2001
SE5
3818
043
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/18731s43ltr.pdf
7/19/2001
AP
0
7/19/2001
SE5
3819
043
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18731s43lbl.pdf
7/19/2001
AP
0
7/19/2001
SE5
8346
043
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/18-731S043_review.pdf
4/14/2004
AP
0
5/3/2001
SLR
5228
045
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18731s39s45lbl.pdf
4/14/2003
AP
0
2/7/2002
SLR
3817
046
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18731s46ltr.pdf
2/7/2002
AP
0
9/21/2007
SLR
17952
048
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018731s048ltr.pdf
9/25/2007
AP
0
9/21/2007
SLR
18024
048
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018731s048lbl.pdf
9/26/2007
AP
0
11/22/2010
SLR
27011
051
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018731s051lbl.pdf
11/22/2010
AP
0
11/22/2010
SLR
27077
051
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018731s051ltr.pdf
11/30/2010
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