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Back to FDA Applications sponsored by FOREST LABS INC
FDA Drug Application 020675 by FOREST LABS INC
Application Number
020675
Application Type
New Drug Application
Sponsor Applicant
FOREST LABS INC
Most Recent Label Available Flag
Current Patent Flag
Action Type
Approval
Chemical Type
New formulation
Therapeutic Potential
Standard
Orphan Code
V
Action Type
Duplicate Counter
Action Date
Document Type
Application Document ID
Sequence Number
Document Title
Document URL
Document Date
AP
0
12/10/1997
N
4347
000
http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20675a.cfm
12/10/1997
AP
0
4/17/1998
SCM
AP
0
2/2/2001
SCP
AP
0
2/8/2000
SCM
AP
0
1/30/2001
SCP
AP
0
3/8/2001
SCM
1585
006
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20675s7ltr.pdf
3/8/2001
AP
0
3/8/2001
SLR
1595
007
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20675s7ltr.pdf
3/8/2001
AP
0
7/21/2004
SE2
9856
009
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20675s009ltr.pdf
7/28/2004
AP
0
7/21/2004
SE2
9875
009
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20675s009lbl.pdf
7/28/2004
AP
0
9/24/2004
SLR
10296
011
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20675s011ltr.pdf
9/29/2004
AP
0
3/10/2008
SCP
19430
013
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020675s013ltr.pdf
3/13/2008
AP
0
3/10/2008
SCP
19441
013
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020675s013lbl.pdf
3/13/2008
AP
0
11/25/2009
SLR
24167
017
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020675s017lbl.pdf
12/2/2009
AP
0
2/27/2013
SCM
AP
0
6/14/2013
SLR
36304
022
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020675s022lbl.pdf
6/18/2013
AP
0
6/14/2013
SLR
36334
022
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020675Orig1s022ltr.pdf
6/18/2013
AP
0
8/19/2013
SCM
AP
0
8/21/2013
SCM
AP
0
9/11/2013
SCM
Back to FDA Applications sponsored by FOREST LABS INC