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Back to FDA Applications sponsored by ABBOTT
FDA Drug Application 020632 by ABBOTT
Application Number
020632
Application Type
New Drug Application
Sponsor Applicant
ABBOTT
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
11/22/1997
N
5938
000
http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20632_meridia.cfm
6/17/2003
AP
0
11/22/1997
N
26349
000
REMS
http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM224378.pdf
9/1/2010
AP
0
8/7/1998
SCM
AP
0
8/7/1998
SCM
19166
002
http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020632_S002_MERIDIA_CAPSULES.pdf
2/19/2008
AP
0
7/6/1999
SCP
19210
004
http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020632_S004_MERIDA_CAPSULES.pdf
2/19/2008
AP
0
11/12/1999
SLR
19209
006
http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020632_S006_MERIDIA_CAPSULES.pdf
2/19/2008
AP
0
2/16/2001
SE8
1547
008
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20632S008011ltr.pdf
2/16/2001
AP
0
2/16/2001
SE8
1548
008
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20632s8s11LBL.pdf
2/16/2001
AP
0
2/16/2001
SE2
1549
011
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20632S008011ltr.pdf
2/16/2001
AP
0
2/16/2001
SE2
1550
011
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20632s8s11LBL.pdf
2/16/2001
AP
0
4/25/2002
SCM
AP
0
8/7/2002
SCP
19206
014
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020632_S014_MERIDIA.pdf
2/19/2008
AP
0
10/8/2002
SCM
19205
015
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020632_S015_MERIDIA.pdf
2/19/2008
AP
0
9/25/2003
SLR
6716
017
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20632slr017ltr.pdf
9/30/2003
AP
0
9/25/2003
SLR
17146
017
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020632_S017_MERIDIA_AP.pdf
7/9/2007
AP
0
11/24/2004
SCP
10688
019
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20632s019,020ltr.pdf
12/2/2004
AP
0
11/24/2004
SCP
10707
019
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20632s019,020lbl.pdf
12/3/2004
AP
0
11/24/2004
SLR
10689
020
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20632s019,020ltr.pdf
12/2/2004
AP
0
12/8/2005
SE5
13257
021
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020632s021lbl.pdf
12/15/2005
AP
0
12/8/2005
SE5
13270
021
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020632s021ltr.pdf
12/15/2005
AP
0
12/8/2005
SE5
17208
021
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm191652.htm
7/9/2007
AP
0
7/29/2005
SLR
12499
024
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020632s024ltr.pdf
8/3/2005
AP
0
7/29/2005
SLR
12510
024
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020632s024lbl.pdf
8/3/2005
AP
0
8/23/2006
SLR
14763
026
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020632s026lbl.pdf
8/29/2006
AP
0
8/23/2006
SLR
14879
026
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020632s026ltr.pdf
9/18/2006
AP
0
5/29/2008
SLR
19904
030
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020632s030, 020381s032ltr.pdf
5/30/2008
AP
0
12/24/2008
SLR
21432
031
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020632s031ltr.pdf
12/30/2008
AP
0
12/24/2008
SLR
21460
031
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020632s031lbl.pdf
1/2/2009
AP
0
5/4/2009
SLR
22447
032
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020632s032ltr.pdf
5/6/2009
AP
0
5/4/2009
SLR
22478
032
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020632s032lbl.pdf
5/11/2009
AP
0
8/4/2010
SLR
26167
034
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020632s034s035lbl.pdf
8/10/2010
AP
0
8/4/2010
SLR
26169
034
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020632s034s035MedGuide.pdf
8/10/2010
AP
0
8/4/2010
SLR
26191
034
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020632s034,s035ltr.pdf
8/10/2010
AP
0
8/4/2010
SLR
26168
035
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020632s034s035lbl.pdf
8/10/2010
AP
0
8/4/2010
SLR
26170
035
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020632s034s035MedGuide.pdf
8/10/2010
AP
0
8/4/2010
SLR
26192
035
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020632s034,s035ltr.pdf
8/10/2010
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