| Action Date | Supplement Number | Approval Type | Letters, Reviews, Labels, Patient Package Insert |
|
7/12/2006
| 095 | Labeling Revision |
Letter
|
|
12/14/2005
| 094 | Labeling Revision |
Letter
|
|
7/29/1998
| 092 | Control Supplement |
|
|
7/14/1998
| 091 | Package Change |
|
|
4/15/1997
| 090 | Control Supplement |
|
|
7/16/1996
| 089 | Manufacturing Change or Addition |
|
|
1/19/1996
| 088 | Control Supplement |
|
|
2/22/1995
| 087 | Labeling Revision |
|
|
11/10/1993
| 086 | Manufacturing Change or Addition |
|
|
9/29/1993
| 085 | Control Supplement |
|
|
6/8/1993
| 084 | Manufacturing Change or Addition |
|
|
7/16/1992
| 082 | Control Supplement |
|
|
1/7/1992
| 081 | Labeling Revision |
|
|
8/27/1992
| 080 | Control Supplement |
|
|
11/13/1991
| 078 | Labeling Revision |
|
|
11/13/1989
| 077 | Labeling Revision |
|
|
5/30/1990
| 075 | Control Supplement |
|
|
3/7/1991
| 074 | New or Modified Indication |
|
|
6/26/1989
| 073 | Labeling Revision |
|
|
6/26/1989
| 072 | Labeling Revision |
|
|
6/15/1988
| 069 | Labeling Revision |
|
|
5/20/1988
| 068 | Labeling Revision |
|
|
3/31/1988
| 067 | New Dosage Regimen |
|
|
4/29/1986
| 066 | New or Modified Indication |
|
|
4/23/1986
| 065 | Labeling Revision |
|
|
1/13/1986
| 064 | Labeling Revision |
|
|
12/18/1985
| 063 | Manufacturing Change or Addition |
|
|
4/30/1986
| 062 | Control Supplement |
|
|
4/18/1985
| 061 | Labeling Revision |
|
|
2/7/1985
| 059 | Labeling Revision |
|
|
4/29/1986
| 057 | New Dosage Regimen |
|
|
9/26/1984
| 055 | Package Change |
|
|
6/18/1984
| 054 | Labeling Revision |
|
|
7/19/1984
| 053 | Labeling Revision |
|
|
3/22/1984
| 052 | Labeling Revision |
|
|
3/5/1984
| 051 | Labeling Revision |
|
|
9/23/1983
| 050 | Manufacturing Change or Addition |
|
|
7/19/1984
| 048 | Labeling Revision |
|
|
12/14/1983
| 047 | General Efficacy (MarkIV) |
|
|
2/28/1983
| 045 | Labeling Revision |
|
|
1/31/1983
| 044 | General Efficacy (MarkIV) |
|
|
12/27/1984
| 043 | General Efficacy (MarkIV) |
|
|
1/4/1983
| 042 | Control Supplement |
|
|
8/25/1982
| 041 | General Efficacy (MarkIV) |
|
|
1/22/1982
| 038 | Labeling Revision |
|
|
11/2/1981
| 037 | Labeling Revision |
|
|
7/13/1981
| 036 | Labeling Revision |
|
|
12/30/1982
| 035 | Labeling Revision |
|
|
1/22/1981
| 032 | Labeling Revision |
|
|
1/22/1981
| 031 | Labeling Revision |
|
|
12/30/1982
| 030 | General Efficacy (MarkIV) |
|
|
6/2/1981
| 029 | Formulation Revision |
|
|
7/8/1980
| 028 | Labeling Revision |
|
|
7/8/1980
| 027 | Labeling Revision |
|
|
7/8/1980
| 026 | Labeling Revision |
|
|
4/23/1980
| 024 | Labeling Revision |
|
|
8/28/1981
| 023 | Expiration Date Change |
|
|
1/7/1980
| 022 | Package Change |
|
|
6/29/1979
| 019 | Labeling Revision |
|
|
1/8/1980
| 018 | Control Supplement |
|
|
4/23/1980
| 017 | General Efficacy (MarkIV) |
|
|
2/1/1979
| 016 | Labeling Revision |
|
|
2/28/1979
| 015 | Control Supplement |
|
|
11/30/1978
| 014 | Labeling Revision |
|
|
11/30/1978
| 013 | Labeling Revision |
|
|
9/28/1978
| 011 | Labeling Revision |
|
|
9/28/1978
| 009 | Manufacturing Change or Addition |
|
|
4/23/1980
| 008 | General Efficacy (MarkIV) |
|
|
3/16/1978
| 005 | Expiration Date Change |
|
|
11/30/1977
| 004 | Labeling Revision |
|
|
11/30/1977
| 003 | Labeling Revision |
|
|
3/17/1978
| 001 | Labeling Revision |
|
|
8/16/1977
| 000 | Approval |
|