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Back to FDA Applications sponsored by ABBVIE
FDA Drug Application 020381 by ABBVIE
Application Number
020381
Application Type
New Drug Application
Sponsor Applicant
ABBVIE
Most Recent Label Available Flag
Current Patent Flag
Action Type
Approval
Chemical Type
New formulation
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
7/28/1997
N
AP
0
3/23/1998
SCM
AP
0
3/2/1998
SCS
AP
0
5/12/1998
SCM
AP
0
8/24/1998
SCM
AP
0
10/28/1999
SE1
1170
006
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20381S6LTR.PDF
10/28/1999
AP
0
9/13/1999
SE2
1309
007
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20381s07ltr.pdf
9/13/1999
AP
0
5/8/2000
SCM
AP
0
6/9/2000
SCS
AP
0
8/2/2000
SCS
AP
0
8/2/2000
SCS
AP
0
11/24/2000
SCM
AP
0
1/31/2003
SE1
4160
013
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020381s013lbl.pdf
3/5/2003
AP
0
1/31/2003
SE1
9264
013
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20381se1-013ltr.pdf
6/10/2004
AP
0
9/5/2002
SCS
AP
0
6/8/2005
SLR
11787
020
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020381s020ltr.pdf
6/10/2005
AP
0
6/8/2005
SLR
11788
020
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020381s020lbl.pdf
6/10/2005
AP
0
9/9/2005
SCF
12781
023
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020381s023ltr.pdf
9/15/2005
AP
0
9/9/2005
SCF
12802
023
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020381s023lbl.pdf
9/15/2005
AP
0
4/11/2006
SLR
13893
025
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020381s025lbl.pdf
4/12/2006
AP
0
4/11/2006
SLR
13902
025
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020381s025ltr.pdf
4/12/2006
AP
0
4/4/2007
SCS
16168
027
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020381s027ltr.pdf
4/9/2007
AP
0
5/29/2008
SLR
19905
032
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020632s030, 020381s032ltr.pdf
5/30/2008
AP
0
12/18/2007
SLR
18685
034
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020381s034lbl.pdf
12/27/2007
AP
0
12/18/2007
SLR
18833
034
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020381s034ltr.pdf
1/9/2008
AP
0
3/26/2009
SLR
22141
038
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020381s038ltr.pdf
4/1/2009
AP
0
9/16/2009
SLR
23428
039
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020381s039s041lbl.pdf
9/21/2009
AP
0
9/16/2009
SLR
23836
039
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020381s039s041ltr.pdf
11/12/2009
AP
0
9/16/2009
SLR
23429
041
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020381s039s041lbl.pdf
9/21/2009
AP
0
9/16/2009
SLR
23837
041
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020381s039s041ltr.pdf
11/12/2009
AP
0
2/24/2010
SLR
24915
042
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020381s042ltr.pdf
3/3/2010
AP
0
2/24/2010
SLR
24927
042
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020381s042lbl.pdf
3/3/2010
AP
0
11/9/2010
SLR
26929
043
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020381s043ltr.pdf
11/12/2010
AP
0
11/9/2010
SLR
26944
043
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020381s043lbl.pdf
11/12/2010
AP
0
2/21/2013
SLR
35225
048
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020381Orig1s048,022078Orig1s015ltr.pdf
2/25/2013
AP
0
2/21/2013
SLR
35257
048
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020381s048lbl.pdf
2/26/2013
AP
0
6/18/2013
SCM
AP
0
5/27/2015
SCM
AP
0
4/27/2015
SLR
42662
051
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020381Orig1s051lbl.pdf
4/27/2015
AP
0
4/27/2015
SLR
42669
051
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020381Orig1s051ltr.pdf
4/28/2015
AP
0
10/28/2015
SCM
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