| Action Date | Supplement Number | Approval Type | Letters, Reviews, Labels, Patient Package Insert |
|
9/12/2007
| 062 | Labeling Revision |
Letter
|
|
3/19/2007
| 057 | New or Modified Indication |
Letter
Label
|
|
8/15/2006
| 054 | Labeling Revision |
Letter
Label
|
|
8/15/2006
| 050 | New or Modified Indication |
Letter
Label
|
|
1/6/2006
| 048 | Formulation Revision |
Letter
|
|
6/21/2005
| 040 | Patient Population Altered |
Letter
Label
|
|
1/24/2006
| 038 | Labeling Revision |
Letter
|
|
10/26/2004
| 033 | Labeling Revision |
Letter
|
|
10/26/2004
| 032 | Labeling Revision |
Letter
|
|
9/3/2003
| 030 | Labeling Revision |
Letter
|
|
10/17/2002
| 022 | Control Supplement |
|
|
4/17/2002
| 021 | Control Supplement |
|
|
4/1/2002
| 020 | Control Supplement |
|
|
5/22/2002
| 019 | Labeling Revision |
Letter
|
|
5/7/2002
| 018 | Manufacturing Change or Addition |
|
|
1/4/2002
| 017 | Manufacturing Change or Addition |
|
|
1/4/2002
| 016 | Manufacturing Change or Addition |
|
|
10/24/2001
| 015 | Control Supplement |
|
|
11/27/2001
| 014 | Manufacturing Change or Addition |
|
|
5/22/2002
| 013 | Labeling Revision |
Letter
|
|
11/27/2001
| 012 | Manufacturing Change or Addition |
|
|
4/26/2001
| 011 | Manufacturing Change or Addition |
|
|
7/5/2001
| 010 | Control Supplement |
|
|
12/4/2000
| 009 | Control Supplement |
|
|
12/4/2000
| 008 | Control Supplement |
|
|
10/4/2000
| 007 | Manufacturing Change or Addition |
|
|
8/9/2000
| 006 | Manufacturing Change or Addition |
|
|
7/27/2000
| 005 | Manufacturing Change or Addition |
|
|
5/15/2000
| 004 | Manufacturing Change or Addition |
|
|
4/10/2000
| 003 | Labeling Revision |
|
|
11/30/1999
| 000 | Approval |
Letter
Label
Review
Patient Information Sheet
|