| Action Date | Supplement Number | Approval Type | Letters, Reviews, Labels, Patient Package Insert |
|
7/26/2004
| 047 | Labeling Revision |
Letter
Label
|
|
4/22/2003
| 045 | Labeling Revision |
Letter
|
|
4/22/2003
| 044 | Labeling Revision |
Letter
|
|
11/7/2001
| 041 | Labeling Revision |
Letter
|
|
4/22/2003
| 040 | Labeling Revision |
Letter
|
|
3/9/1999
| 039 | Labeling Revision |
Review
|
|
2/3/1998
| 038 | Manufacturing Change or Addition |
|
|
6/1/2000
| 037 | Labeling Revision |
|
|
6/24/1996
| 036 | Labeling Revision |
|
|
5/31/1994
| 035 | Labeling Revision |
|
|
2/22/1989
| 034 | Labeling Revision |
|
|
8/31/1992
| 033 | Control Supplement |
|
|
9/12/1988
| 031 | Manufacturing Change or Addition |
|
|
10/21/1986
| 030 | Labeling Revision |
|
|
5/5/1987
| 029 | Formulation Revision |
|
|
4/15/1986
| 028 | Package Change |
|
|
4/23/1986
| 027 | Labeling Revision |
|
|
1/16/1986
| 026 | Control Supplement |
|
|
10/21/1985
| 025 | Labeling Revision |
|
|
8/20/1985
| 024 | Labeling Revision |
|
|
1/18/1985
| 022 | Package Change |
|
|
3/12/1985
| 021 | Labeling Revision |
|
|
9/21/1984
| 020 | Control Supplement |
|
|
5/1/1984
| 019 | Labeling Revision |
|
|
5/1/1984
| 018 | Package Change |
|
|
7/5/1983
| 017 | Labeling Revision |
|
|
5/11/1983
| 016 | Control Supplement |
|
|
4/13/1983
| 015 | Labeling Revision |
|
|
11/12/1982
| 014 | Labeling Revision |
|
|
9/8/1982
| 013 | Labeling Revision |
|
|
7/27/1983
| 012 | Formulation Revision |
|
|
9/23/1982
| 011 | Control Supplement |
|
|
2/25/1982
| 010 | Control Supplement |
|
|
2/19/1982
| 009 | Manufacturing Change or Addition |
|
|
12/9/1981
| 008 | Manufacturing Change or Addition |
|
|
2/18/1982
| 007 | Package Change |
|
|
11/6/1981
| 006 | Package Change |
|
|
8/15/1984
| 005 | General Efficacy (MarkIV) |
|
|
5/13/1981
| 004 | Control Supplement |
|
|
5/13/1981
| 003 | Manufacturing Change or Addition |
|
|
6/28/1982
| 002 | General Efficacy (MarkIV) |
|
|
5/13/1981
| 001 | Package Change |
|
|
12/30/1980
| 000 | Approval |
|