| Action Date | Supplement Number | Approval Type | Letters, Reviews, Labels, Patient Package Insert |
|
12/17/2004
| 040 | Labeling Revision |
Letter
Label
|
|
5/28/2004
| 039 | Labeling Revision |
Letter
Label
|
|
5/28/2004
| 036 | Labeling Revision |
Letter
Label
|
|
3/14/2002
| 035 | Manufacturing Change or Addition |
|
|
8/20/2001
| 034 | Manufacturing Change or Addition |
|
|
12/10/1997
| 031 | Labeling Revision |
|
|
6/27/1996
| 029 | Control Supplement |
|
|
6/27/1996
| 028 | Control Supplement |
|
|
12/7/1995
| 027 | Labeling Revision |
|
|
11/28/1995
| 026 | Labeling Revision |
|
|
1/20/1995
| 025 | Manufacturing Change or Addition |
|
|
2/10/1995
| 024 | Formulation Revision |
|
|
5/18/1994
| 023 | Formulation Revision |
|
|
4/5/1993
| 022 | Labeling Revision |
|
|
8/9/1993
| 021 | Control Supplement |
|
|
9/22/1995
| 020 | Labeling Revision |
|
|
1/22/1992
| 019 | Control Supplement |
|
|
10/24/1991
| 018 | New or Modified Indication |
|
|
6/12/1990
| 017 | Manufacturing Change or Addition |
|
|
6/19/1990
| 015 | Labeling Revision |
|
|
6/18/1990
| 014 | Control Supplement |
|
|
1/19/1990
| 013 | Formulation Revision |
|
|
2/3/1989
| 011 | Manufacturing Change or Addition |
|
|
7/1/1988
| 010 | Control Supplement |
|
|
5/25/1988
| 009 | Package Change |
|
|
4/28/1988
| 008 | Labeling Revision |
|
|
7/7/1987
| 007 | Labeling Revision |
|
|
1/7/1988
| 006 | Manufacturing Change or Addition |
|
|
1/7/1988
| 005 | Manufacturing Change or Addition |
|
|
1/7/1988
| 004 | Manufacturing Change or Addition |
|
|
1/7/1988
| 003 | Manufacturing Change or Addition |
|
|
2/26/1987
| 002 | Labeling Revision |
|
|
12/3/1986
| 001 | Control Supplement |
|
|
9/10/1986
| 000 | Approval |
|