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Back to FDA Applications sponsored by SANOFI AVENTIS US
FDA Drug Application 006002 by SANOFI AVENTIS US
Application Number
006002
Application Type
New Drug Application
Sponsor Applicant
SANOFI AVENTIS US
Most Recent Label Available Flag
Current Patent Flag
Action Type
Approval
Chemical Type
Therapeutic Potential
Orphan Code
Action Type
Duplicate Counter
Action Date
Document Type
Application Document ID
Sequence Number
Document Title
Document URL
Document Date
AP
0
10/31/1949
N
AP
0
1/29/1975
SCS
AP
0
3/31/1976
SLR
AP
0
4/12/1976
SCS
AP
0
5/22/1978
SCM
AP
0
1/8/1980
SCP
AP
0
8/8/1980
SCM
AP
0
5/15/1981
SCP
AP
0
5/15/1981
SCP
AP
0
10/14/1986
SPD
AP
0
11/14/1986
SPD
AP
0
5/14/1982
SCS
AP
0
3/27/1987
SLR
AP
0
6/18/1987
SCM
AP
0
6/9/1989
SLR
AP
0
7/13/1990
SCM
AP
0
2/18/1993
SLR
AP
0
5/17/1991
SCS
AP
0
3/11/1992
SCM
AP
0
6/23/1992
SCF
AP
0
10/11/1995
SCS
AP
0
5/9/2001
SCS
AP
0
6/13/2003
SLR
5941
039
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/06002slr039ltr.pdf
6/22/2003
AP
0
6/13/2003
SLR
6005
039
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/06002slr039_aralen_lbl.pdf
6/22/2003
AP
0
4/30/2002
SCS
AP
0
6/12/2009
SLR
22764
042
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/006002s042ltr.pdf
6/17/2009
AP
0
11/6/2013
SLR
37737
043
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/006002s043lbl.pdf
11/8/2013
AP
0
11/6/2013
SLR
37740
043
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/006002Orig1s043ltr.pdf
11/8/2013
Back to FDA Applications sponsored by SANOFI AVENTIS US