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Back to FDA Applications sponsored by GLAXOSMITHKLINE
FDA Drug Application 021319 by GLAXOSMITHKLINE
Application Number
021319
Application Type
New Drug Application
Sponsor Applicant
GLAXOSMITHKLINE
Most Recent Label Available Flag
Current Patent Flag
Action Type
Approval
Chemical Type
New molecular entity (NME)
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
11/20/2001
N
4679
000
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21319_Duagen_approv.PDF
11/20/2001
AP
0
11/20/2001
N
4680
000
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21319lbl.pdf
11/20/2001
AP
0
11/20/2001
N
4681
000
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21319_Duagen.cfm
11/20/2001
AP
0
11/20/2001
N
31030
000
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm258424.htm
12/20/2011
AP
0
10/9/2002
SE1
4604
001
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21319se1-001ltr.pdf
10/9/2002
AP
0
10/9/2002
SE1
4605
001
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21-319s1lbl.pdf
10/9/2002
AP
0
10/9/2002
SCP
AP
0
12/31/2002
SCM
AP
0
3/12/2004
SLR
7994
005
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21319slr005ltr.pdf
3/19/2004
AP
0
8/5/2004
SLR
9947
007
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21319s007ltr.pdf
8/6/2004
AP
0
8/5/2004
SLR
9950
007
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21319s007lbl.pdf
8/6/2004
AP
0
9/14/2004
S
10196
008
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21319s008ltr.pdf
9/15/2004
AP
0
9/14/2004
S
10197
008
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21319s008lbl.pdf
9/15/2004
AP
0
12/23/2005
SLR
13359
009
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021319s009rev2.pdf
1/6/2006
AP
0
6/19/2008
SE1
20053
014
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021319se1-014ltr.pdf
6/23/2008
AP
0
6/19/2008
SE1
20086
014
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021319s014lbl.pdf
6/26/2008
AP
0
6/19/2008
SE1
20228
014
http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/021319se1-014_SUMR.pdf
7/17/2008
AP
0
3/31/2008
SLR
19555
015
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021319s015lbl.pdf
4/1/2008
AP
0
3/31/2008
SLR
19564
015
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021319s015ltr.pdf
4/2/2008
AP
0
6/15/2010
SLR
25758
018
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021319s018ltr.pdf
6/18/2010
AP
0
6/15/2010
SLR
25785
018
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021319s018lbl.pdf
6/24/2010
AP
0
9/9/2010
SLR
26444
022
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021319s022lbl.pdf
9/10/2010
AP
0
9/9/2010
SLR
26474
022
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021319s022ltr.pdf
9/13/2010
AP
0
6/9/2011
SE1
29099
023
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021319s023s025lbl.pdf
6/10/2011
AP
0
6/9/2011
SE1
29101
023
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021319s023,s025ltr.pdf
6/10/2011
AP
0
6/9/2011
SLR
29100
025
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021319s023s025lbl.pdf
6/10/2011
AP
0
6/9/2011
SLR
29102
025
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021319s023,s025ltr.pdf
6/10/2011
AP
0
6/27/2012
SLR
33050
027
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021319s027lbl.pdf
6/28/2012
AP
0
6/27/2012
SLR
33054
027
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021319s027ltr.pdf
6/29/2012
AP
0
4/30/2013
SLR
35901
028
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021319s028s029lbl.pdf
5/1/2013
AP
0
4/30/2013
SLR
35933
028
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021319Orig1s028,s029ltr.pdf
5/2/2013
AP
0
4/30/2013
SLR
35902
029
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021319s028s029lbl.pdf
5/1/2013
AP
0
4/30/2013
SLR
35934
029
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021319Orig1s028,s029ltr.pdf
5/2/2013
AP
0
9/10/2013
SCM
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