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Back to FDA Applications sponsored by TAKEDA PHARMS NA
FDA Drug Application 021507 by TAKEDA PHARMS NA
Application Number
021507
Application Type
New Drug Application
Sponsor Applicant
TAKEDA PHARMS NA
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
11/14/2003
N
6996
000
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21507ltr.pdf
11/28/2003
AP
0
11/14/2003
N
11858
000
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21507_PrevacidTOC.cfm
6/23/2005
AP
0
11/14/2003
N
15842
000
http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088694.pdf
2/20/2007
AP
0
11/14/2003
N
31071
000
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm213259.htm
12/20/2011
AP
0
4/12/2006
SLR
13928
004
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021507s004ltr.pdf
4/13/2006
AP
0
8/31/2006
SLR
14782
005
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021507s005,007lbl.pdf
9/1/2006
AP
0
8/31/2006
SLR
14781
007
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021507s005,007lbl.pdf
9/1/2006
AP
0
10/20/2008
SLR
21052
008
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021507s008ltr.pdf
10/23/2008
AP
0
7/31/2009
S
23176
009
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021507s009lbl.pdf
8/13/2009
AP
0
7/31/2009
S
23784
009
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021507s009ltr.pdf
11/10/2009
Back to FDA Applications sponsored by TAKEDA PHARMS NA