| Action Date | Supplement Number | Approval Type | Letters, Reviews, Labels, Patient Package Insert |
|
1/12/2005
| 035 | Labeling Revision |
Letter
Label
|
|
5/27/2004
| 034 | Labeling Revision |
Letter
|
|
6/20/2002
| 033 | Labeling Revision |
Letter
|
|
5/5/2003
| 031 | Labeling Revision |
Letter
Review
|
|
4/23/2002
| 030 | Manufacturing Change or Addition |
|
|
1/8/2002
| 029 | Labeling Revision |
Letter
|
|
12/4/2001
| 028 | Labeling Revision |
Letter
Review
|
|
3/11/2002
| 027 | Control Supplement |
|
|
3/21/2001
| 026 | Labeling Revision |
Letter
Review
|
|
1/23/2001
| 025 | Labeling Revision |
|
|
11/9/2000
| 024 | Manufacturing Change or Addition |
|
|
6/1/2000
| 023 | Labeling Revision |
|
|
4/10/2000
| 022 | Manufacturing Change or Addition |
|
|
11/30/1999
| 021 | Control Supplement |
|
|
9/9/1999
| 020 | Labeling Revision |
|
|
6/1/2000
| 019 | Labeling Revision |
|
|
9/23/1999
| 018 | Manufacturing Change or Addition |
|
|
6/1/2000
| 017 | Labeling Revision |
|
|
6/1/2000
| 016 | Labeling Revision |
|
|
6/1/2000
| 015 | Labeling Revision |
|
|
1/27/1999
| 013 | Manufacturing Change or Addition |
|
|
8/6/1997
| 012 | Labeling Revision |
|
|
3/31/1998
| 011 | Labeling Revision |
Letter
|
|
5/5/1997
| 010 | Labeling Revision |
Review
|
|
5/5/1997
| 009 | Labeling Revision |
Review
|
|
12/2/1996
| 008 | Manufacturing Change or Addition |
|
|
1/13/1997
| 007 | Control Supplement |
|
|
7/26/2000
| 006 | Labeling Revision |
Review
|
|
2/6/1997
| 005 | Manufacturing Change or Addition |
|
|
3/28/1996
| 004 | Manufacturing Change or Addition |
|
|
6/25/1996
| 003 | Labeling Revision |
|
|
3/20/1996
| 002 | Manufacturing Change or Addition |
|
|
3/28/1996
| 001 | Manufacturing Change or Addition |
|
|
12/22/1994
| 000 | Approval |
Other Important Information from FDA
|