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Back to FDA Applications sponsored by SHIRE
FDA Drug Application 020712 by SHIRE
Application Number
020712
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
9/30/1997
N
16228
000
http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020712_carbatrol_toc.cfm
4/17/2007
AP
0
7/24/1998
SCS
AP
0
1/27/1999
SCS
AP
0
1/27/1999
SCM
AP
0
6/28/1999
SCP
AP
0
6/28/1999
SCP
AP
0
12/22/1999
SCM
AP
0
11/8/1999
SCP
AP
0
1/19/2000
SCS
AP
0
6/14/2000
SCM
AP
0
5/17/2001
SCS
AP
0
8/8/2000
SCM
AP
0
8/8/2000
SCM
AP
0
10/30/2001
SCM
AP
0
2/21/2002
SCM
AP
0
8/7/2002
SCM
AP
0
1/24/2006
SLR
13542
024
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020712s024ltr.pdf
1/30/2006
AP
0
6/30/2006
SLR
14397
025
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020712s025lbl.pdf
7/3/2006
AP
0
6/30/2006
SLR
14468
025
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020712s025LTR.pdf
7/13/2006
AP
0
12/11/2007
SLR
18640
029
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020712s029lbl.pdf
12/12/2007
AP
0
12/11/2007
SLR
18694
029
Clinical Review
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/016608s098,020712s029,021710_ClinRev.pdf
12/31/2007
AP
0
12/11/2007
SLR
18849
029
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020712s029ltr.pdf
1/9/2008
AP
0
4/23/2009
SLR
22342
030
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020712s030lbl.pdf
4/28/2009
AP
0
4/23/2009
SLR
22358
030
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020712s030ltr.pdf
4/29/2009
AP
0
1/26/2011
SLR
27642
031
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020712s031MedG.pdf
1/31/2011
AP
0
1/26/2011
SLR
27643
031
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020712s031lbl.pdf
1/31/2011
AP
0
1/26/2011
SLR
27679
031
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020712s031ltr.pdf
2/3/2011
AP
0
3/22/2013
SLR
35507
032
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020712Orig1s032,s035ltr.pdf
3/25/2013
AP
0
3/22/2013
SLR
35517
032
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020712s032s035lbl.pdf
3/26/2013
AP
0
3/22/2013
SLR
36121
032
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020712s032s035mg.pdf
5/22/2013
AP
0
8/22/2011
SLR
29954
034
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020712s034ltr.pdf
9/6/2011
AP
0
3/22/2013
SLR
35506
035
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020712Orig1s032,s035ltr.pdf
3/25/2013
AP
0
3/22/2013
SLR
35518
035
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020712s032s035lbl.pdf
3/26/2013
AP
0
3/22/2013
SLR
36122
035
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020712s032s035mg.pdf
5/22/2013
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