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Back to FDA Applications sponsored by LEO PHARMA AS
FDA Drug Application 020554 by LEO PHARMA AS
Application Number
020554
Application Type
New Drug Application
Sponsor Applicant
LEO PHARMA AS
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
7/22/1996
N
AP
0
12/18/1998
SCS
AP
0
3/11/1999
SCS
AP
0
1/11/2000
SLR
AP
0
3/23/2001
SCP
AP
0
4/28/2005
SLR
11551
006
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020554s006ltr.pdf
5/2/2005
AP
0
4/28/2005
SLR
11558
006
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020554s006lbl.pdf
5/2/2005
AP
0
9/26/2007
SLR
18143
007
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020611s007,020554s007,020273s009ltr.pdf
10/4/2007
AP
0
9/26/2007
SLR
18173
007
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020611s007,020554s007,020273s009lbl.pdf
10/4/2007
AP
0
6/12/2014
SCM
AP
0
1/14/2014
SCM
AP
0
11/21/2013
SCM
AP
0
3/11/2015
SLR
42147
012
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020554Orig1s12,020273Orig1s13ltr.pdf
3/13/2015
AP
0
3/11/2015
SLR
42170
012
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020273s013,020554s012lbl.pdf
3/17/2015
Back to FDA Applications sponsored by LEO PHARMA AS