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Back to FDA Applications sponsored by ENDO PHARMS
FDA Drug Application 017111 by ENDO PHARMS
Application Number
017111
Application Type
New Drug Application
Sponsor Applicant
ENDO PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type
Approval
Chemical Type
New molecular entity (NME)
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
1/18/1974
N
AP
0
9/23/1974
SCS
AP
0
9/20/1976
SLR
AP
0
8/26/1976
SCP
AP
0
3/14/1977
SCS
AP
0
5/27/1977
SCP
AP
0
2/7/1977
SCF
AP
0
2/7/1977
SCF
AP
0
6/7/1977
SCS
AP
0
1/5/1981
SCF
AP
0
12/20/1979
SCE
AP
0
5/10/1979
SLR
AP
0
9/27/1979
SCP
AP
0
8/16/1979
SLR
AP
0
1/6/1981
SCF
AP
0
3/24/1981
SLR
AP
0
11/19/1982
SLR
AP
0
6/26/1985
SCP
AP
0
6/11/1986
SCP
AP
0
9/23/1987
SCM
AP
0
6/28/1988
SCP
AP
0
6/28/1988
SLR
AP
0
8/8/1988
SCM
AP
0
8/12/1994
SCM
AP
0
8/28/1995
SCS
AP
0
8/28/1995
SCS
AP
0
8/28/1995
SCS
AP
0
4/25/1996
SCS
AP
0
8/21/1998
SCM
AP
0
8/21/1998
SCS
AP
0
5/22/2001
SLR
5115
055
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17111s55ltr.pdf
4/9/2003
AP
0
3/12/2008
SLR
19467
062
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017111s062ltr.pdf
3/17/2008
AP
0
3/12/2008
SLR
19472
062
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017111s062lbl.pdf
3/17/2008
AP
0
8/14/2008
SLR
20622
063
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017111s063ltr.pdf
8/19/2008
AP
0
8/14/2008
SLR
20710
063
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017111s063lbl.pdf
8/29/2008
AP
0
7/19/2009
SLR
23022
066
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017111s066lbl.pdf
7/23/2009
AP
0
7/19/2009
SLR
23026
066
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017111s066ltr.pdf
7/23/2009
AP
0
12/1/2010
SLR
27183
067
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017111s067lbl.pdf
12/4/2010
AP
0
12/1/2010
SLR
27197
067
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/017111s067ltr.pdf
12/6/2010
Back to FDA Applications sponsored by ENDO PHARMS