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Back to FDA Applications sponsored by LEO PHARMA AS
FDA Drug Application 022185 by LEO PHARMA AS
Application Number
022185
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
5/9/2008
N
19836
000
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022185s000ltr.pdf
5/15/2008
AP
0
5/9/2008
N
20251
000
http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/022185s000_SUMR.pdf
7/17/2008
AP
0
5/9/2008
N
22240
000
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022185_taclonex_scalp_toc.cfm
4/14/2009
AP
0
3/20/2009
SCP
22094
003
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022185s003ltr.pdf
3/24/2009
AP
0
10/17/2012
SE1
34124
010
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022185s010lbl.pdf
10/18/2012
AP
0
10/17/2012
SE1
34136
010
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022185Orig1s010ltr.pdf
10/22/2012
AP
0
11/30/2012
SLR
34525
012
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022185Orig1s012ltr.pdf
12/4/2012
AP
0
11/30/2012
SLR
34541
012
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022185s012lbl.pdf
12/4/2012
AP
0
6/28/2013
SCM
AP
0
11/7/2013
SCM
37756
015
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022185Orig1s015,s016ltr.pdf
11/8/2013
AP
0
11/7/2013
SCM
37856
015
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022185Orig1s015, s016lbl.pdf
11/19/2013
AP
0
11/7/2013
SLR
37755
016
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022185Orig1s015,s016ltr.pdf
11/8/2013
AP
0
11/7/2013
SLR
37759
016
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022185Orig1s015, s016lbl.pdf
11/8/2013
AP
0
2/26/2014
SCM
AP
0
8/29/2014
SE8
40368
018
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022185Orig1s018ltr.pdf
9/3/2014
AP
0
8/29/2014
SE8
40402
018
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022185s018lbl.pdf
9/3/2014
AP
0
10/29/2015
SCM
44372
019
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022185s019lbl.pdf
11/4/2015
AP
0
7/28/2014
SLR
40029
020
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022185Orig1s020ltr.pdf
7/29/2014
AP
0
7/28/2014
SLR
40041
020
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022185s020lbl.pdf
7/29/2014
AP
0
2/5/2016
SCM
AP
0
3/18/2016
SCM
AP
0
6/21/2016
SCM
46410
024
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022185s024lbl.pdf
6/23/2016
Back to FDA Applications sponsored by LEO PHARMA AS