| Action Date | Supplement Number | Approval Type | Letters, Reviews, Labels, Patient Package Insert |
|
4/19/2004
| 051 | Labeling Revision |
Letter
|
|
4/19/2004
| 050 | Labeling Revision |
Letter
|
|
11/7/2001
| 048 | Labeling Revision |
Letter
|
|
1/29/2001
| 047 | Control Supplement |
|
|
1/22/2001
| 046 | Control Supplement |
|
|
1/22/2001
| 045 | Control Supplement |
|
|
8/27/1999
| 043 | Manufacturing Change or Addition |
|
|
3/9/1999
| 042 | Labeling Revision |
Review
|
|
1/30/1998
| 041 | Manufacturing Change or Addition |
|
|
6/1/2000
| 040 | Labeling Revision |
|
|
6/24/1996
| 039 | Labeling Revision |
|
|
5/31/1994
| 038 | Labeling Revision |
|
|
2/16/1990
| 037 | Package Change |
|
|
2/22/1989
| 036 | Labeling Revision |
|
|
8/31/1992
| 035 | Control Supplement |
|
|
9/12/1988
| 033 | Manufacturing Change or Addition |
|
|
9/15/1987
| 032 | Labeling Revision |
|
|
4/17/1987
| 031 | Control Supplement |
|
|
10/23/1986
| 030 | Labeling Revision |
|
|
5/28/1987
| 029 | Package Change |
|
|
11/20/1985
| 026 | Manufacturing Change or Addition |
|
|
10/21/1985
| 025 | Labeling Revision |
|
|
8/20/1985
| 024 | Labeling Revision |
|
|
3/12/1985
| 022 | Labeling Revision |
|
|
5/28/1987
| 021 | New or Modified Indication |
|
|
7/5/1983
| 020 | General Efficacy (MarkIV) |
|
|
6/14/1983
| 019 | Manufacturing Change or Addition |
|
|
8/3/1984
| 018 | Manufacturing Change or Addition |
|
|
4/13/1983
| 017 | Labeling Revision |
|
|
1/4/1983
| 016 | Manufacturing Change or Addition |
|
|
11/12/1982
| 015 | Labeling Revision |
|
|
11/2/1982
| 014 | Formulation Revision |
|
|
9/8/1982
| 013 | Labeling Revision |
|
|
6/23/1982
| 012 | Manufacturing Change or Addition |
|
|
5/27/1982
| 010 | Manufacturing Change or Addition |
|
|
2/19/1982
| 009 | General Efficacy (MarkIV) |
|
|
12/9/1981
| 008 | Manufacturing Change or Addition |
|
|
10/8/1981
| 007 | Control Supplement |
|
|
6/28/1982
| 006 | General Efficacy (MarkIV) |
|
|
1/25/1980
| 005 | Control Supplement |
|
|
12/28/1979
| 004 | Labeling Revision |
|
|
1/22/1981
| 003 | General Efficacy (MarkIV) |
|
|
10/16/1979
| 002 | Control Supplement |
|
|
10/1/1979
| 001 | Labeling Revision |
|
|
2/7/1979
| 000 | Approval |
|