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Back to FDA Applications sponsored by FOREST LABS
FDA Drug Application 021742 by FOREST LABS
Application Number
021742
Application Type
New Drug Application
Sponsor Applicant
FOREST LABS
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
12/17/2007
N
18826
000
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021742s000ltr.pdf
1/9/2008
AP
0
12/17/2007
N
19756
000
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021742s000TOC.cfm
5/2/2008
AP
0
2/19/2010
SE1
24867
007
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021742s007ltr.pdf
2/26/2010
AP
0
2/19/2010
SE1
24939
007
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021742s007lbl.pdf
3/3/2010
AP
0
12/14/2011
SLR
30983
013
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021742s013lbl.pdf
12/14/2011
AP
0
12/14/2011
SLR
31000
013
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021742s013ltr.pdf
12/15/2011
AP
0
12/19/2012
SCM
AP
0
9/20/2013
SCM
AP
0
10/30/2014
SCM
AP
0
10/27/2014
SCM
AP
0
4/20/2015
SCM
Back to FDA Applications sponsored by FOREST LABS