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Back to FDA Applications sponsored by ROCHE
FDA Drug Application 016087 by ROCHE
Application Number
016087
Application Type
New Drug Application
Sponsor Applicant
ROCHE
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
8/24/1966
N
AP
0
6/20/1974
SLR
AP
0
6/5/1974
SLR
AP
0
11/15/1974
SCS
AP
0
12/2/1974
SCS
AP
0
5/1/1975
SCS
AP
0
11/13/1975
SCS
AP
0
4/23/1976
SCP
AP
0
7/23/1976
SCF
AP
0
10/18/1977
SCP
AP
0
10/24/1978
SCS
AP
0
3/15/1980
SCS
AP
0
3/23/1979
SLR
AP
0
4/9/1979
SCM
AP
0
5/31/1979
SLR
AP
0
11/2/1979
SLR
AP
0
7/20/1979
SLR
AP
0
5/19/1980
SLR
AP
0
4/20/1981
SCM
AP
0
4/16/1981
SCM
AP
0
3/26/1981
SLR
AP
0
4/16/1981
SCS
AP
0
8/24/1981
SCP
AP
0
11/13/1981
SLR
AP
0
11/12/1981
SLR
AP
0
11/19/1981
SCP
AP
0
8/5/1982
SLR
AP
0
5/18/1982
SCS
AP
0
10/27/1982
SCM
AP
0
8/20/1982
SCS
AP
0
10/29/1982
SCS
AP
0
3/1/1983
SCM
AP
0
4/6/1983
SLR
AP
0
3/14/1983
SLR
AP
0
3/14/1983
SLR
AP
0
3/14/1983
SLR
AP
0
3/29/1983
SCS
AP
0
4/18/1983
SCP
AP
0
6/26/1985
SCS
AP
0
6/26/1985
SCS
AP
0
5/31/1985
SCM
AP
0
6/27/1985
SLR
AP
0
8/6/1985
SCM
AP
0
1/15/1986
SCP
AP
0
6/16/1986
SCP
AP
0
6/16/1986
SCS
AP
0
10/29/1986
SCS
AP
0
10/27/1987
SCS
AP
0
4/23/1987
SCS
AP
0
2/7/2002
SLR
2091
079
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16087s79s81ltr.pdf
2/7/2002
AP
0
5/25/1993
SCS
AP
0
2/7/2002
SLR
2094
081
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16087s79s81ltr.pdf
2/7/2002
AP
0
11/5/1997
SCM
AP
0
9/17/1997
SCS
AP
0
9/4/1998
SCS
Back to FDA Applications sponsored by ROCHE