| Action Date | Supplement Number | Approval Type | Letters, Reviews, Labels, Patient Package Insert |
|
11/15/2004
| 046 | Labeling Revision |
Letter
|
|
10/15/2004
| 043 | Labeling Revision |
Letter
|
|
10/15/2004
| 041 | Labeling Revision |
Letter
|
|
10/15/2004
| 040 | Labeling Revision |
Letter
|
|
7/10/2002
| 035 | Manufacturing Change or Addition |
Letter
|
|
8/2/2002
| 034 | Labeling Revision |
Letter
|
|
7/26/2001
| 033 | Manufacturing Change or Addition |
|
|
3/28/2001
| 032 | Manufacturing Change or Addition |
|
|
12/19/2000
| 031 | Manufacturing Change or Addition |
|
|
5/25/2001
| 030 | Control Supplement |
|
|
9/21/2000
| 029 | Manufacturing Change or Addition |
|
|
10/4/2000
| 028 | New or Modified Indication |
Review
|
|
3/16/2000
| 027 | Manufacturing Change or Addition |
|
|
2/29/2000
| 026 | Manufacturing Change or Addition |
|
|
12/16/1998
| 025 | Labeling Revision |
Review
|
|
9/24/1998
| 024 | Package Change |
|
|
9/22/1998
| 023 | Package Change |
|
|
2/25/1998
| 022 | Manufacturing Change or Addition |
|
|
12/4/1997
| 021 | Manufacturing Change or Addition |
|
|
11/25/1997
| 020 | Manufacturing Change or Addition |
|
|
9/3/1996
| 019 | Labeling Revision |
|
|
3/13/1996
| 018 | Control Supplement |
|
|
9/27/1995
| 017 | Control Supplement |
|
|
1/29/1996
| 016 | Package Change |
|
|
5/5/1995
| 015 | Control Supplement |
|
|
7/13/1995
| 014 | Labeling Revision |
|
|
7/13/1995
| 013 | Labeling Revision |
|
|
8/22/1995
| 012 | Control Supplement |
|
|
10/21/1994
| 011 | Labeling Revision |
|
|
8/22/1995
| 010 | New or Modified Indication |
|
|
3/1/1995
| 009 | Labeling Revision |
|
|
1/14/1994
| 008 | Labeling Revision |
|
|
5/20/1993
| 007 | Package Change |
|
|
1/8/1993
| 006 | Labeling Revision |
|
|
6/25/1992
| 005 | Labeling Revision |
|
|
5/18/1992
| 004 | Control Supplement |
|
|
1/9/1992
| 003 | Package Change |
|
|
5/20/1991
| 002 | Control Supplement |
|
|
5/20/1991
| 001 | Control Supplement |
|
|
1/28/1991
| 000 | Approval |
Other Important Information from FDA
|