| Action Date | Supplement Number | Approval Type | Letters, Reviews, Labels, Patient Package Insert |
|
4/13/2005
| 108 | Manufacturing Change or Addition |
Letter
|
|
12/15/2004
| 107 | Manufacturing Change or Addition |
Letter
|
|
1/27/2004
| 106 | Labeling Revision |
Letter
Label
|
|
7/30/2003
| 105 | Labeling Revision |
Letter
|
|
1/3/2003
| 104 | Labeling Revision |
Letter
|
|
2/20/2002
| 103 | Labeling Revision |
Letter
|
|
2/20/2002
| 102 | Labeling Revision |
Letter
|
|
5/8/2001
| 100 | Labeling Revision |
|
|
10/29/1999
| 099 | Labeling Revision |
|
|
2/12/1999
| 098 | Control Supplement |
|
|
6/22/1998
| 097 | Manufacturing Change or Addition |
|
|
11/8/2000
| 096 | Labeling Revision |
|
|
5/20/1997
| 095 | Labeling Revision |
|
|
4/25/1995
| 094 | Control Supplement |
|
|
1/23/1992
| 089 | Manufacturing Change or Addition |
|
|
11/5/1991
| 086 | Package Change |
|
|
10/24/1990
| 085 | Control Supplement |
|
|
2/20/1991
| 083 | Control Supplement |
|
|
3/1/1989
| 081 | Control Supplement |
|
|
4/21/1988
| 079 | Formulation Revision |
|
|
4/7/1988
| 078 | Control Supplement |
|
|
4/7/1988
| 077 | New or Modified Indication |
Label
|
|
1/18/1990
| 076 | Labeling Revision |
|
|
12/8/1986
| 075 | Manufacturing Change or Addition |
|
|
8/18/1987
| 074 | Manufacturing Change or Addition |
|
|
9/16/1986
| 073 | Labeling Revision |
|
|
9/16/1986
| 071 | Manufacturing Change or Addition |
|
|
3/19/1987
| 070 | Manufacturing Change or Addition |
|
|
4/8/1983
| 063 | Control Supplement |
|
|
8/24/1982
| 062 | Labeling Revision |
|
|
4/8/1983
| 059 | Manufacturing Change or Addition |
|
|
3/31/1982
| 058 | Control Supplement |
|
|
3/31/1982
| 057 | Labeling Revision |
|
|
12/7/1981
| 056 | Manufacturing Change or Addition |
|
|
5/11/1981
| 054 | Manufacturing Change or Addition |
|
|
12/3/1980
| 053 | Expiration Date Change |
|
|
2/29/1980
| 052 | Control Supplement |
|
|
10/15/1979
| 051 | Manufacturing Change or Addition |
|
|
6/11/1980
| 050 | Manufacturing Change or Addition |
|
|
2/15/1979
| 049 | Control Supplement |
|
|
12/14/1978
| 047 | Control Supplement |
|
|
8/8/1978
| 046 | Manufacturing Change or Addition |
|
|
1/2/1979
| 043 | Control Supplement |
|
|
8/22/1978
| 039 | Control Supplement |
|
|
7/14/1977
| 038 | Manufacturing Change or Addition |
|
|
3/18/1977
| 037 | Control Supplement |
|
|
3/28/1977
| 036 | Manufacturing Change or Addition |
|
|
8/2/1977
| 035 | Manufacturing Change or Addition |
|
|
9/14/1976
| 033 | Control Supplement |
|
|
9/14/1976
| 032 | Control Supplement |
|
|
9/7/1976
| 031 | Control Supplement |
|
|
9/7/1976
| 030 | Manufacturing Change or Addition |
|
|
9/7/1976
| 029 | Control Supplement |
|
|
6/29/1976
| 028 | Control Supplement |
|
|
8/3/1976
| 027 | Manufacturing Change or Addition |
|
|
6/29/1976
| 026 | Labeling Revision |
|
|
6/29/1976
| 025 | Manufacturing Change or Addition |
|
|
12/5/1975
| 024 | Labeling Revision |
|
|
11/3/1975
| 023 | Labeling Revision |
|
|
11/3/1975
| 022 | Final Printed Labeling - MarkIV |
|
|
7/22/1975
| 021 | Control Supplement |
|
|
8/10/1959
| 000 | Approval |
|