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Back to FDA Applications sponsored by ENDO PHARMS
FDA Drug Application 016023 by ENDO PHARMS
Application Number
016023
Application Type
New Drug Application
Sponsor Applicant
ENDO PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type
Approval
Chemical Type
New formulation
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
2/14/1968
N
AP
0
1/7/1976
SCS
AP
0
11/16/1977
SCM
AP
0
8/10/1977
SCM
AP
0
12/8/1982
SCP
AP
0
1/4/1985
SCP
AP
0
2/14/1986
SLR
AP
0
1/16/1987
SE1
AP
0
4/19/1993
SE2
AP
0
10/23/1989
SLR
AP
0
2/6/1992
SCP
AP
0
2/4/1992
SCM
AP
0
8/11/1992
SCM
AP
0
1/5/1996
SCS
AP
0
6/8/1999
SCP
AP
0
12/6/2000
SLR
AP
0
1/11/2002
SCS
AP
0
11/18/2003
SLR
6947
037
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18101slr009,16023slr037ltr.pdf
11/25/2003
AP
0
11/18/2003
SLR
8403
037
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/018101s009lbl.pdf
4/27/2004
AP
0
11/18/2003
SLR
14070
037
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/016023s037_018101s009_SymmetrelTOC.cfm
5/8/2006
AP
0
3/2/2007
SLR
15975
039
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016023s039, 018101s014.pdf
3/7/2007
AP
0
3/2/2007
SLR
15988
039
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016023s039,018101s014lbl.pdf
3/7/2007
AP
0
9/24/2008
SLR
20888
040
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/016023s040, 018101s015ltr.pdf
9/26/2008
AP
0
9/24/2008
SLR
20938
040
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016023s040,018101s015lbl.pdf
10/3/2008
AP
0
2/2/2009
SLR
21701
041
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/016023s041,018101s016ltr.pdf
2/3/2009
AP
0
2/2/2009
SLR
21746
041
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016023s041,018101s016lbl.pdf
2/4/2009
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