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Back to FDA Applications sponsored by SANTARUS INC
FDA Drug Application 021849 by SANTARUS INC
Application Number
021849
Application Type
New Drug Application
Sponsor Applicant
SANTARUS INC
Most Recent Label Available Flag
Current Patent Flag
Action Type
Approval
Chemical Type
New combination
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
2/27/2006
N
13714
000
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021849s000lbl.pdf
3/3/2006
AP
0
2/27/2006
N
13715
000
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021849s000ltr.pdf
3/3/2006
AP
0
2/27/2006
N
19774
000
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021849TOC.cfm
5/7/2008
AP
0
2/27/2006
N
31064
000
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm213259.htm
12/20/2011
AP
0
12/21/2007
SCF
18725
002
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021849s002lbl.pdf
1/8/2008
AP
0
12/21/2007
SCF
18764
002
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021849s002ltr.pdf
1/9/2008
AP
0
12/21/2007
SCF
30809
002
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021849Orig1s002.pdf
10/10/2011
AP
0
1/20/2010
SLR
24678
003
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021636s008,021849s003,021850s002ltr.pdf
1/29/2010
AP
0
9/3/2010
SLR
26424
004
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021636s009,021849s004,021850s003,022456s002ltr.pdf
9/8/2010
AP
0
9/3/2010
SLR
26468
004
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021636s009,021849s004,021850s003,022456s002lbl.pdf
9/10/2010
AP
0
5/20/2011
SLR
28932
005
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021636s010,021849s005ltr.pdf
5/25/2011
AP
0
5/20/2011
SLR
28951
005
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021636s010,021849s005lbl.pdf
5/25/2011
AP
0
12/7/2011
SLR
30931
006
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021636s011,021849s006ltr.pdf
12/13/2011
AP
0
12/7/2011
SLR
31001
006
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021636s011,021849s006lbl.pdf
12/15/2011
AP
0
11/9/2012
SLR
34373
007
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021636Orig1s012,021849Orig1s007ltr.pdf
11/14/2012
AP
0
11/9/2012
SLR
34388
007
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021636s012,021849s007mg.pdf
11/15/2012
AP
0
11/9/2012
SLR
34389
007
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021636s012,021849s007lbl.pdf
11/15/2012
AP
0
4/19/2012
SLR
32479
008
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021636s013,021849s008lbl.pdf
4/20/2012
AP
0
4/19/2012
SLR
32507
008
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021636s013,021849s008ltr.pdf
4/23/2012
AP
0
2/25/2014
SLR
38624
009
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021636s015,021849s009lbl.pdf
2/27/2014
AP
0
2/25/2014
SLR
38635
009
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021636Orig1s015,021849Orig1s009ltr.pdf
3/4/2014
AP
0
12/19/2014
SLR
41390
010
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021636Orig1s016,021849Orig1s010ltr.pdf
12/24/2014
AP
0
12/19/2014
SLR
41423
010
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021849s010021636s016lbl.pdf
12/29/2014
AP
0
6/1/2016
SCM
AP
0
10/24/2016
SLR
47462
012
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021849Orig1s012,021636Orig1s017ltr.pdf
10/26/2016
AP
0
10/24/2016
SLR
47527
012
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021636s017,021849s012lbl.pdf
10/31/2016
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