| Action Date | Supplement Number | Approval Type | Letters, Reviews, Labels, Patient Package Insert |
|
7/14/2006
| 039 | New or Modified Indication |
Letter
|
|
4/5/2006
| 037 | Labeling Revision |
Letter
|
|
4/26/2005
| 033 | Efficacy Supplement with Clinical Data to Support |
Letter
Label
|
|
4/20/2005
| 032 | Labeling Revision |
Letter
Label
|
|
5/19/2004
| 029 | New or Modified Indication |
Letter
Label
|
|
11/13/2002
| 022 | Control Supplement |
|
|
5/1/2002
| 021 | Control Supplement |
Letter
|
|
5/18/2001
| 020 | Control Supplement |
|
|
11/1/2000
| 019 | Control Supplement |
|
|
1/4/2001
| 018 | Control Supplement |
|
|
6/9/2000
| 017 | Control Supplement |
|
|
6/22/2000
| 016 | Control Supplement |
|
|
3/3/2000
| 014 | Control Supplement |
|
|
1/6/2003
| 013 | Labeling Revision |
Letter
Label
|
|
11/23/1998
| 011 | Manufacturing Change or Addition |
|
|
6/23/2000
| 010 | Labeling Revision |
|
|
10/16/1998
| 007 | Control Supplement |
|
|
1/23/1998
| 006 | Manufacturing Change or Addition |
|
|
8/25/1998
| 005 | New or Modified Indication |
Letter
Label
|
|
9/18/1997
| 004 | Labeling Revision |
|
|
10/10/1997
| 003 | Manufacturing Change or Addition |
|
|
4/11/1997
| 002 | Control Supplement |
|
|
2/5/1997
| 001 | Manufacturing Change or Addition |
|
|
5/15/1996
| 000 | Approval |
Label
|