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Back to FDA Applications sponsored by CLINIGEN HLTHCARE
FDA Drug Application 020068 by CLINIGEN HLTHCARE
Application Number
020068
Application Type
New Drug Application
Sponsor Applicant
CLINIGEN HLTHCARE
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
9/27/1991
N
AP
0
12/12/1995
SLR
AP
0
6/16/1995
SE1
AP
0
11/17/1995
SLR
AP
0
1/24/1997
SE1
AP
0
1/24/1997
SE2
AP
0
1/24/1997
SLR
AP
0
3/31/1997
SLR
AP
0
1/3/1997
SCS
AP
0
11/16/1998
SCS
AP
0
6/13/2000
SLR
AP
0
6/13/2000
SLR
AP
0
5/15/2006
SLR
14096
016
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020068s016lbl.pdf
5/16/2006
AP
0
5/15/2006
SLR
14123
016
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020068s016LTR.pdf
5/18/2006
AP
0
11/27/2007
SLR
18612
017
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020068s017lbl.pdf
12/3/2007
AP
0
2/10/2012
SCM
32359
018
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020068s018lbl.pdf
4/6/2012
AP
0
6/10/2014
SCM
AP
0
11/7/2014
SLR
40979
020
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020068Orig1s020ltr.pdf
11/12/2014
AP
0
11/7/2014
SLR
42732
020
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020068s020lbl.pdf
5/5/2015
AP
0
5/29/2015
SCM
Back to FDA Applications sponsored by CLINIGEN HLTHCARE