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Back to FDA Applications sponsored by FOREST LABS LLC
FDA Drug Application 021627 by FOREST LABS LLC
Application Number
021627
Application Type
New Drug Application
Sponsor Applicant
FOREST LABS LLC
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
4/18/2005
N
11437
000
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021627ltr.pdf
4/19/2005
AP
0
4/18/2005
N
11438
000
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021627lbl.pdf
4/19/2005
AP
0
4/18/2005
N
15134
000
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021627s000_NamendaTOC.cfm
10/18/2006
AP
0
10/4/2006
SLR
15096
001
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021487s008,021627s001LTR.pdf
10/13/2006
AP
0
4/19/2006
SLR
13971
002
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021487s007, 021627s002LTR.pdf
4/21/2006
AP
0
10/24/2013
SLR
37570
008
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021487Orig1s010,s012,s014,021627Orig1s008ltr.pdf
10/25/2013
AP
0
10/24/2013
SLR
37577
008
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021487s010s012s014,021627s008lbl.pdf
10/25/2013
AP
0
7/10/2014
SCM
AP
0
8/11/2014
SLR
40202
012
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021627Orig1s012ltr.pdf
8/12/2014
AP
0
8/11/2014
SLR
40213
012
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021627s012lbl.pdf
8/12/2014
Back to FDA Applications sponsored by FOREST LABS LLC