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Back to FDA Applications sponsored by SHIRE
FDA Drug Application 022000 by SHIRE
Application Number
022000
Application Type
New Drug Application
Sponsor Applicant
SHIRE
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
1/16/2007
N
15684
000
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022000lbl.pdf
1/18/2007
AP
0
1/16/2007
N
15712
000
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022000s000ltr.pdf
1/25/2007
AP
0
1/16/2007
N
17733
000
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022000s000TOC.cfm
8/31/2007
AP
0
10/30/2009
SLR
24231
002
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022000s002lbl.pdf
12/10/2009
AP
0
9/22/2010
SLR
26536
003
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022000s003lbl.pdf
9/23/2010
AP
0
9/22/2010
SLR
26544
003
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022000s003ltr.pdf
9/27/2010
AP
0
7/14/2011
SE8
29522
005
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022000s005ltr.pdf
7/18/2011
AP
0
7/14/2011
SE8
29525
005
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022000s005lbl.pdf
7/18/2011
AP
0
7/14/2011
SE8
42056
005
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022000Orig1s005.pdf
3/9/2015
AP
0
8/9/2013
SLR
36771
008
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022000Orig1s008,022000Orig1s010ltr.pdf
8/12/2013
AP
0
8/9/2013
SLR
36775
008
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022000s008s010lbl.pdf
8/12/2013
AP
0
8/28/2013
SLR
36920
009
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022000Orig1s009ltr.pdf
8/29/2013
AP
0
8/28/2013
SLR
37217
009
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022000Orig1s009lbl.pdf
9/24/2013
AP
0
8/9/2013
SLR
36770
010
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022000Orig1s008,022000Orig1s010ltr.pdf
8/12/2013
AP
0
8/9/2013
SLR
36776
010
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022000s008s010lbl.pdf
8/12/2013
AP
0
12/16/2013
SLR
38073
011
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022000Orig1s011ltr.pdf
12/17/2013
AP
0
12/16/2013
SLR
38079
011
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022000s011lbl.pdf
12/17/2013
AP
0
3/14/2014
SLR
AP
0
10/16/2014
SLR
40835
013
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022000Orig1s013ltr.pdf
10/21/2014
AP
0
10/16/2014
SLR
40851
013
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022000s013lbl.pdf
10/21/2014
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