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Back to FDA Applications sponsored by SANOFI AVENTIS US
FDA Drug Application 021759 by SANOFI AVENTIS US
Application Number
021759
Application Type
New Drug Application
Sponsor Applicant
SANOFI AVENTIS US
Most Recent Label Available Flag
Current Patent Flag
Action Type
Approval
Chemical Type
New manufacturer
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
1/31/2005
N
11073
000
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021759ltr.pdf
2/3/2005
AP
0
1/31/2005
N
11077
000
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021759lbl.pdf
2/3/2005
AP
0
1/31/2005
N
16870
000
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021759s000TOC.cfm
7/2/2007
AP
0
3/9/2006
SLR
13762
001
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021759s001,021492s006lbl.pdf
3/14/2006
AP
0
3/9/2006
SLR
13767
001
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021759s001,021492s006ltr.pdf
3/14/2006
AP
0
5/21/2008
SLR
19885
008
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021492se8_010,021759s008ltr.pdf
5/28/2008
AP
0
3/13/2009
SLR
22006
009
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021492s011,021759s009ltr.pdf
3/17/2009
AP
0
3/13/2009
SLR
22120
009
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021492s011,021759s009lbl.pdf
3/26/2009
AP
0
12/28/2011
SLR
31307
012
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021759s012lbl.pdf
12/28/2011
AP
0
12/28/2011
SLR
31322
012
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021492s012,021759s012ltr.pdf
1/3/2012
AP
0
10/12/2012
SLR
34099
015
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021759s015lbl.pdf
10/15/2012
AP
0
10/12/2012
SLR
34110
015
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021759Orig1s015ltr.pdf
10/16/2012
AP
0
7/16/2013
SLR
36566
016
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021759s016lbl.pdf
7/17/2013
AP
0
7/16/2013
SLR
36573
016
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021759Orig1s016ltr.pdf
7/18/2013
AP
0
11/15/2013
SCM
AP
0
1/20/2015
SCM
AP
0
10/1/2015
SLR
44114
019
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021759Orig1s019ltr.pdf
10/6/2015
AP
0
10/1/2015
SLR
44165
019
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021759s019lbledt.pdf
10/7/2015
Back to FDA Applications sponsored by SANOFI AVENTIS US