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Back to FDA Applications sponsored by TAKEDA PHARMS USA
FDA Drug Application 203414 by TAKEDA PHARMS USA
Application Number
203414
Application Type
New Drug Application
Sponsor Applicant
TAKEDA PHARMS USA
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
1/25/2013
N
34998
000
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203414Orig1s000ltr.pdf
1/30/2013
AP
0
1/25/2013
N
35019
000
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203414s000lbl.pdf
1/30/2013
AP
0
1/25/2013
N
35068
000
http://www.fda.gov/downloads/Drugs/DrugSafety/UCM337729.pdf
2/5/2013
AP
0
1/25/2013
N
39100
000
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203414Orig1s000TOC.cfm
4/18/2014
AP
0
1/25/2013
N
39101
000
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203414Orig1s000SumR.pdf
4/18/2014
AP
0
10/17/2013
SCM
AP
0
4/5/2016
SE8
45597
003
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022271Orig1s005,022426Orig1s003,203414Orig1s003ltr.pdf
4/7/2016
AP
0
4/5/2016
SE8
45615
003
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203414s003lbl.pdf
4/7/2016
AP
0
8/21/2014
SCM
AP
0
8/28/2015
SLR
43766
005
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022271Orig1s007,022426Orig1s005,203414Orig1s005ltr.pdf
9/1/2015
AP
0
8/28/2015
SLR
43922
005
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203414s005lbl.pdf
9/21/2015
Back to FDA Applications sponsored by TAKEDA PHARMS USA