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Back to FDA Applications sponsored by BRISTOL MYERS SQUIBB
FDA Drug Application 020457 by BRISTOL MYERS SQUIBB
Application Number
020457
Application Type
New Drug Application
Sponsor Applicant
BRISTOL MYERS SQUIBB
Most Recent Label Available Flag
Current Patent Flag
Action Type
Approval
Chemical Type
New ester, new salt, or other noncovalent derivative
Therapeutic Potential
Standard
Orphan Code
Action Type
Duplicate Counter
Action Date
Document Type
Application Document ID
Sequence Number
Document Title
Document URL
Document Date
AP
0
5/17/1996
N
AP
0
12/21/2001
SLR
AP
0
2/21/2002
SLR
1823
003
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20457s3s4ltr.pdf
2/21/2002
AP
0
2/21/2002
SLR
1824
004
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20457s3s4ltr.pdf
2/21/2002
AP
0
8/16/1999
SCM
AP
0
11/5/2002
SLR
1821
006
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20457slr006,20906slr002ltr.pdf
11/5/2002
AP
0
3/17/2011
SLR
28275
013
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020457s013ltr.pdf
3/21/2011
AP
0
3/17/2011
SLR
28300
013
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020457s013lbl.pdf
3/21/2011
AP
0
7/30/2015
SLR
43548
014
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020457Orig1s014ltr.pdf
7/31/2015
AP
0
7/30/2015
SLR
43568
014
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020457s014lbl.pdf
8/4/2015
Back to FDA Applications sponsored by BRISTOL MYERS SQUIBB