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Back to FDA Applications sponsored by BRISTOL MYERS SQUIBB
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
Duplicate Counter
Action Date
Document Type
Application Document ID
Sequence Number
Document Title
Document URL
Document Date
AP
0
12/7/1967
N
AP
0
5/3/1977
SCS
AP
0
2/19/1980
SCS
AP
0
9/24/1996
SLR
AP
0
3/19/1987
SCS
AP
0
7/16/1985
SCM
AP
0
3/19/1987
SCS
AP
0
5/10/1988
SCF
AP
0
8/25/1988
SCS
AP
0
9/5/1995
SCS
AP
0
7/31/1992
SCS
AP
0
3/9/1993
SCF
AP
0
9/24/1996
SLR
AP
0
10/15/1996
SCS
AP
0
11/25/1996
SCP
AP
0
8/11/1999
SLR
AP
0
4/7/1997
SCM
AP
0
5/23/1997
SCM
AP
0
2/25/1998
SE1
AP
0
2/25/1998
SCS
AP
0
11/10/1998
SCM
AP
0
1/12/2000
SLR
AP
0
4/4/2001
SLR
2270
034
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/16295S34ltr.pdf
4/4/2001
AP
0
2/20/2001
SLR
AP
0
6/26/2003
SE2
6031
036
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/16295se2-036ltr.pdf
7/6/2003
AP
0
6/26/2003
SE2
6081
036
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/16295se2-036_droxia_lbl.pdf
7/8/2003
AP
0
6/26/2003
SE2
8335
036
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/16-295S036_Droxia.cfm
4/14/2004
AP
0
2/19/2004
SLR
7775
037
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/16295slr037ltr.pdf
3/2/2004
AP
0
2/19/2004
SLR
8185
037
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/16295slr037_hydrea_lbl.pdf
4/5/2004
AP
0
9/19/2006
SLR
14905
039
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/016295s039, 016295s036ltr.pdf
9/20/2006
AP
0
9/19/2006
SLR
14917
039
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/016295s039s036lbl.pdf
9/20/2006
AP
0
5/7/2010
SLR
25523
040
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/016295s040ltr.pdf
5/12/2010
AP
0
5/7/2010
SLR
25571
040
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/016295s040lbl.pdf
5/17/2010
AP
0
1/26/2012
SLR
31579
041
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/016295s041,s042ltr.pdf
1/30/2012
AP
0
1/26/2012
SLR
31615
041
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016295s041s042lbl.pdf
1/31/2012
AP
0
1/26/2012
SLR
31580
042
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/016295s041,s042ltr.pdf
1/30/2012
AP
0
1/26/2012
SLR
31616
042
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016295s041s042lbl.pdf
1/31/2012
AP
0
7/16/2015
SLR
43405
045
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/016295s045lbl.pdf
7/17/2015
AP
0
7/16/2015
SLR
43407
045
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/016295Orig1s045ltr.pdf
7/20/2015
AP
0
7/16/2015
SLR
43406
046
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/016295s046lbl.pdf
7/17/2015
AP
0
7/16/2015
SLR
43408
046
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/016295Orig1s046ltr.pdf
7/20/2015
AP
0
3/23/2016
SLR
45506
047
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/016295Orig1s047,s048ltr.pdf
3/25/2016
AP
0
3/23/2016
SLR
45509
047
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016295Orig1s047,s048Lbl.pdf
3/28/2016
AP
0
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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