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Back to FDA Applications sponsored by MALLINCKRODT IP
FDA Drug Application 022450 by MALLINCKRODT IP
Application Number
022450
Application Type
New Drug Application
Sponsor Applicant
MALLINCKRODT IP
Most Recent Label Available Flag
Current Patent Flag
Action Type
Approval
Chemical Type
New manufacturer
Therapeutic Potential
Priority
Orphan Code
Action Type
Duplicate Counter
Action Date
Document Type
Application Document ID
Sequence Number
Document Title
Document URL
Document Date
AP
0
11/2/2010
N
26896
000
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022450lbl.pdf
11/5/2010
AP
0
11/2/2010
N
26897
000
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022450s000ltr.pdf
11/8/2010
AP
0
11/2/2010
N
28456
000
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022450_ofirmev_toc.cfm
4/4/2011
AP
0
11/2/2010
N
28457
000
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022450Orig1s000SumR.pdf
4/4/2011
AP
0
4/5/2013
SCM
AP
0
4/19/2013
SCM
AP
0
10/18/2013
SLR
37484
005
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022450Orig1s005,s006ltr.pdf
10/21/2013
AP
0
10/18/2013
SLR
37527
005
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022450s005s006lbl.pdf
10/22/2013
AP
0
10/18/2013
SLR
37483
006
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022450Orig1s005,s006ltr.pdf
10/21/2013
AP
0
10/18/2013
SLR
37528
006
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022450s005s006lbl.pdf
10/22/2013
AP
0
9/4/2016
SCM
Back to FDA Applications sponsored by MALLINCKRODT IP