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Back to FDA Applications sponsored by ASTRAZENECA PHARMS
FDA Drug Application 022056 by ASTRAZENECA PHARMS
Application Number
022056
Application Type
New Drug Application
Sponsor Applicant
ASTRAZENECA PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type
Approval
Chemical Type
New formulation
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
3/20/2008
N
19514
000
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022056lbl.pdf
3/24/2008
AP
0
3/20/2008
N
19520
000
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022056s000ltr.pdf
3/24/2008
AP
0
3/20/2008
N
25041
000
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022056_prilosec_toc.cfm
3/16/2010
AP
0
3/20/2008
N
25042
000
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022056s000SumR.pdf
3/16/2010
AP
0
3/20/2008
N
31061
000
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm213259.htm
12/20/2011
AP
0
3/20/2008
N
33943
000
http://www.fda.gov/downloads/Drugs/DrugSafety/UCM322359.pdf
10/3/2012
AP
0
12/1/2008
SLR
21316
001
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019810s087, 022056s001ltr.pdf
12/4/2008
AP
0
12/1/2008
SLR
21325
001
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022056s001019810s087lbl.pdf
12/4/2008
AP
0
3/3/2010
SLR
24971
003
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019810s088,022056s003lbl.pdf
3/5/2010
AP
0
3/3/2010
SLR
24996
003
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019810s088,022056s003ltr.pdf
3/8/2010
AP
0
9/3/2010
SLR
26418
005
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019810s090,022056s005ltr.pdf
9/8/2010
AP
0
9/3/2010
SLR
26463
005
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019810s090,022056s005lbl.pdf
9/10/2010
AP
0
6/30/2011
SLR
29402
007
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022056s007,019810s091ltr.pdf
7/6/2011
AP
0
6/30/2011
SLR
29430
007
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022056s007,019810s091lbl.pdf
7/6/2011
AP
0
1/20/2011
SLR
27575
008
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019810s092,022056s008lbl.pdf
1/24/2011
AP
0
1/20/2011
SLR
27595
008
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019810s092,022056s008ltr.pdf
1/25/2011
AP
0
5/20/2011
SLR
28940
009
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019810s093,022056s009ltr.pdf
5/25/2011
AP
0
5/20/2011
SLR
28953
009
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019810s093,022056s009lbl.pdf
5/25/2011
AP
0
1/20/2012
SLR
31480
010
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019810s094,022056s010ltr.pdf
1/24/2012
AP
0
1/20/2012
SLR
31685
010
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019810s094,022056s010lbledt.pdf
2/6/2012
AP
0
10/9/2012
SLR
34036
011
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019810Orig1s095,022056Orig1s011ltr.pdf
10/11/2012
AP
0
10/9/2012
SLR
34067
011
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019810s095,022056s011mg.pdf
10/12/2012
AP
0
10/9/2012
SLR
34068
011
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019810s095,022056s011lbl.pdf
10/12/2012
AP
0
9/28/2012
SLR
33892
012
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019810s096lbl.pdf
10/1/2012
AP
0
9/28/2012
SLR
33898
012
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019810Orig1s096,022056Orig1s012ltr.pdf
10/2/2012
AP
0
5/13/2013
SLR
36081
013
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019810Orig1s097,022056Orig1s013ltr.pdf
5/16/2013
AP
0
5/13/2013
SLR
36109
013
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019810s097,022056s013lbl.pdf
5/21/2013
AP
0
3/27/2014
SLR
38941
014
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019810s098,022056s014lbl.pdf
4/1/2014
AP
0
3/27/2014
SLR
39034
014
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019810Orig1s098,022056Orig1s014ltr.pdf
4/14/2014
AP
0
2/25/2014
SLR
38612
015
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019810Orig1s099,022056Orig1s015ltr.pdf
2/27/2014
AP
0
2/25/2014
SLR
38627
015
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019810s099,022056s015lbl.pdf
2/27/2014
AP
0
12/19/2014
SLR
41386
017
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019810Orig1s101,022056Orig1s017ltr.pdf
12/24/2014
AP
0
12/19/2014
SLR
41418
017
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022056s017lbl019810s101lbl.pdf
12/29/2014
AP
0
2/3/2016
SLR
45118
018
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022056Orig1s018ltr.pdf
2/4/2016
AP
0
2/3/2016
SLR
45155
018
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022056s018lbl.pdf
2/11/2016
AP
0
10/24/2016
SLR
47452
020
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019810Orig1s103,022056Orig1s020ltr.pdf
10/26/2016
AP
0
10/24/2016
SLR
47532
020
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019810s103,022056s020lbl.pdf
10/31/2016
Back to FDA Applications sponsored by ASTRAZENECA PHARMS