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Back to FDA Applications sponsored by CLINIGEN HLTHCARE
FDA Drug Application 020221 by CLINIGEN HLTHCARE
Application Number
020221
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
V
Action Type
Duplicate Counter
Action Date
Document Type
Application Document ID
Sequence Number
Document Title
Document URL
Document Date
AP
0
12/8/1995
N
AP
0
1/23/1996
SCS
AP
0
3/15/1996
SE1
AP
0
12/30/1996
SCS
AP
0
11/21/1996
SCM
AP
0
12/18/1996
SCM
AP
0
2/20/1997
SCS
AP
0
10/10/1997
SCM
AP
0
3/11/1999
SLR
AP
0
2/11/1999
SCS
AP
0
6/24/1999
SE1
1174
012
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20221s12ltr.pdf
6/24/1999
AP
0
6/24/1999
SE1
1175
012
http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20221s12lbl.pdf
6/24/1999
AP
0
6/24/1999
SE1
1815
012
http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20221-S012_Ethyol.cfm
6/24/1999
AP
0
4/1/1999
SLR
AP
0
9/10/1999
SCS
AP
0
2/20/2002
SLR
1814
015
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20221s15ltr.pdf
2/20/2002
AP
0
3/27/2003
SLR
4654
017
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20221slr017_ethyol_lbl.pdf
3/28/2003
AP
0
3/27/2003
SLR
5277
017
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20221slr017ltr.pdf
4/15/2003
AP
0
3/28/2006
SLR
13850
020
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020221s020ltr.pdf
4/5/2006
AP
0
11/7/2008
SLR
21208
024
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020221s024lbl.pdf
11/12/2008
AP
0
11/7/2008
SLR
21222
024
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020221s024ltr.pdf
11/13/2008
AP
0
8/26/2013
SCM
AP
0
3/9/2016
SCM
AP
0
1/15/2016
SCM
Back to FDA Applications sponsored by CLINIGEN HLTHCARE