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Back to FDA Applications sponsored by SUCAMPO PHARMA LLC
FDA Drug Application 021214 by SUCAMPO PHARMA LLC
Application Number
021214
Application Type
New Drug Application
Sponsor Applicant
SUCAMPO PHARMA LLC
Most Recent Label Available Flag
Current Patent Flag
Action Type
Approval
Chemical Type
New molecular entity (NME)
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
8/3/2000
N
1456
000
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21214ltr.pdf
8/3/2000
AP
0
8/3/2000
N
1457
000
http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21214lbl.pdf
8/3/2000
AP
0
8/3/2000
N
9385
000
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21214_Rescula.cfm
6/16/2004
AP
0
12/5/2001
SCS
AP
0
12/7/2012
SCM
34572
006
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021214s006s007lbl.pdf
12/10/2012
AP
0
12/7/2012
SCM
44512
006
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021214Orig1s006.pdf
11/18/2015
AP
0
12/7/2012
SLR
34573
007
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021214s006s007lbl.pdf
12/10/2012
AP
0
12/7/2012
SLR
44498
007
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021214Orig1s007.pdf
11/17/2015
AP
0
7/10/2014
SCM
Back to FDA Applications sponsored by SUCAMPO PHARMA LLC