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Back to FDA Applications sponsored by VALEANT PHARM INTL
FDA Drug Application 016721 by VALEANT PHARM INTL
Application Number
016721
Application Type
New Drug Application
Sponsor Applicant
VALEANT PHARM INTL
Most Recent Label Available Flag
Current Patent Flag
Action Type
Approval
Chemical Type
New molecular entity (NME)
Therapeutic Potential
Priority
Orphan Code
Action Type
Duplicate Counter
Action Date
Document Type
Application Document ID
Sequence Number
Document Title
Document URL
Document Date
AP
0
4/7/1970
N
16047
000
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101557.htm
3/16/2007
AP
0
4/7/1970
N
23943
000
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016721s077lbl.pdf
11/18/2009
AP
0
4/22/1974
SF
AP
0
9/17/1974
SCS
AP
0
1/16/1975
SCS
AP
0
7/1/1975
SCS
AP
0
7/10/1978
SLR
AP
0
12/10/1976
SLR
AP
0
8/2/1977
SDS
AP
0
6/29/1977
SCS
AP
0
7/12/1977
SCF
AP
0
5/2/1978
SCM
AP
0
7/10/1978
SLR
AP
0
7/20/1978
SLR
AP
0
7/12/1978
SCF
AP
0
7/28/1978
SCF
AP
0
3/26/1979
SCF
AP
0
5/1/1979
SCF
AP
0
9/17/1979
SCM
AP
0
11/9/1979
SCM
AP
0
2/4/1980
SCM
AP
0
6/17/1980
SCP
AP
0
6/17/1980
SCF
AP
0
7/11/1980
SCP
AP
0
8/20/1980
SCS
AP
0
8/20/1980
SCS
AP
0
5/6/1981
SLR
AP
0
3/26/1981
SCS
AP
0
7/17/1981
SCP
AP
0
8/4/1981
SCP
AP
0
11/5/1981
SCM
AP
0
12/22/1981
SCS
AP
0
12/22/1981
SCS
AP
0
1/28/1982
SCP
AP
0
6/15/1982
SCF
AP
0
12/11/1984
SCP
AP
0
11/9/1987
SLR
AP
0
11/7/1989
SCP
AP
0
1/16/1990
SCM
AP
0
4/25/1990
SCS
AP
0
12/31/1992
SCS
AP
0
5/25/1993
SCF
AP
0
6/14/2001
SLR
5113
074
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/16721s74ltr.pdf
6/14/2001
AP
0
8/12/2002
SCM
AP
0
10/30/2007
SLR
18331
076
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016721s076lbl.pdf
11/7/2007
AP
0
10/30/2007
SLR
18379
076
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016721s076,s058ltr.pdf
11/8/2007
AP
0
3/27/2009
SLR
22139
077
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/016721s077ltr.pdf
4/1/2009
AP
0
3/27/2009
SLR
22178
077
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016721s077lbl.pdf
4/3/2009
Back to FDA Applications sponsored by VALEANT PHARM INTL