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Back to FDA Applications sponsored by AEGERION
FDA Drug Application 203858 by AEGERION
Application Number
203858
Application Type
New Drug Application
Sponsor Applicant
AEGERION
Most Recent Label Available Flag
Current Patent Flag
Action Type
Approval
Chemical Type
New molecular entity (NME)
Therapeutic Potential
Standard
Orphan Code
V
Action Type
Duplicate Counter
Action Date
Document Type
Application Document ID
Sequence Number
Document Title
Document URL
Document Date
AP
0
12/21/2012
N
34778
000
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203858Orig1s000ltr_replace.pdf
12/27/2012
AP
0
12/21/2012
N
34791
000
REMS
http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=25
12/28/2012
AP
0
12/21/2012
N
34801
000
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203858s000lbl.pdf
12/31/2012
AP
0
12/21/2012
N
34818
000
http://www.fda.gov/downloads/Drugs/DrugSafety/UCM333530.pdf
1/3/2013
AP
0
12/21/2012
N
35123
000
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/2038858_juxtapid_toc.cfm
2/11/2013
AP
0
8/13/2013
SLR
36783
001
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203858Orig1s001ltr.pdf
8/15/2013
AP
0
4/10/2013
SLR
35686
002
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203858Orig1s002ltr.pdf
4/16/2013
AP
0
4/10/2013
SLR
35717
002
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203858s002lbl.pdf
4/16/2013
AP
0
12/17/2013
SCM
AP
0
4/23/2014
SCM
AP
0
2/18/2014
SLR
38531
006
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203858Orig1s006ltr.pdf
2/19/2014
AP
0
2/18/2014
SLR
38541
006
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203858s006lbl.pdf
2/19/2014
AP
0
11/11/2014
SCM
AP
0
8/8/2014
SLR
40199
009
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203858Orig1s009ltr.pdf
8/11/2014
AP
0
8/8/2014
SLR
40209
009
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203858s009lbl.pdf
8/12/2014
AP
0
4/23/2015
SLR
42650
010
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203858Orig1s010ltr.pdf
4/24/2015
AP
0
4/23/2015
SLR
42654
010
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203858s010lbl.pdf
4/24/2015
AP
0
4/24/2015
SCM
AP
0
3/8/2016
SLR
45403
012
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203858Orig1s012ltr.pdf
3/10/2016
AP
0
3/8/2016
SLR
45430
012
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203858s012lbl.pdf
3/14/2016
AP
0
7/11/2016
SCM
AP
0
5/23/2016
SLR
46138
015
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203858Orig1s015ltr.pdf
5/25/2016
AP
0
5/23/2016
SLR
46146
015
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203858s015lbl.pdf
5/25/2016
Back to FDA Applications sponsored by AEGERION