| Action Date | Supplement Number | Approval Type | Letters, Reviews, Labels, Patient Package Insert |
|
9/2/2005
| 050 | Labeling Revision |
Letter
Label
|
|
1/17/2003
| 044 | Manufacturing Change or Addition |
Letter
Label
|
|
5/28/2002
| 043 | Package Change |
|
|
2/10/2003
| 042 | Manufacturing Change or Addition |
Letter
|
|
5/13/2002
| 041 | Manufacturing Change or Addition |
|
|
1/3/2002
| 040 | Manufacturing Change or Addition |
|
|
6/21/2001
| 039 | Manufacturing Change or Addition |
|
|
7/2/2001
| 038 | Labeling Revision |
|
|
2/17/1999
| 036 | Manufacturing Change or Addition |
|
|
2/17/1999
| 035 | Manufacturing Change or Addition |
|
|
7/31/1998
| 034 | Manufacturing Change or Addition |
|
|
12/17/1998
| 033 | Control Supplement |
|
|
7/24/2002
| 032 | Labeling Revision |
Letter
|
|
10/24/1997
| 031 | Expiration Date Change |
|
|
10/24/1997
| 030 | Control Supplement |
|
|
10/24/1997
| 029 | Control Supplement |
|
|
7/24/2002
| 028 | Labeling Revision |
Letter
|
|
10/24/1997
| 027 | Control Supplement |
|
|
10/21/1996
| 026 | Control Supplement |
|
|
8/14/1996
| 025 | Control Supplement |
|
|
7/16/1996
| 024 | Control Supplement |
|
|
6/12/1996
| 023 | Manufacturing Change or Addition |
|
|
2/16/1996
| 022 | Control Supplement |
|
|
12/6/1994
| 021 | Formulation Revision |
|
|
12/18/1995
| 020 | Formulation Revision |
|
|
2/6/1995
| 019 | Control Supplement |
|
|
5/3/1994
| 017 | New or Modified Indication |
|
|
1/12/1993
| 016 | Control Supplement |
|
|
9/30/1992
| 015 | Manufacturing Change or Addition |
|
|
7/31/1992
| 014 | Labeling Revision |
|
|
10/10/1995
| 012 | Control Supplement |
|
|
11/7/1995
| 011 | Control Supplement |
|
|
2/28/1992
| 010 | Control Supplement |
|
|
10/4/1991
| 008 | Labeling Revision |
|
|
7/3/1991
| 007 | Labeling Revision |
|
|
4/16/1990
| 005 | Labeling Revision |
|
|
6/12/1991
| 004 | Control Supplement |
Review
|
|
6/23/1989
| 003 | Control Supplement |
|
|
10/21/1988
| 000 | Approval |
|