| Action Date | Supplement Number | Approval Type | Letters, Reviews, Labels, Patient Package Insert |
|
9/28/2007
| 045 | New or Modified Indication |
Letter
Label
|
|
10/17/2006
| 039 | New or Modified Indication |
Letter
Label
|
|
6/7/2006
| 036 | Labeling Revision |
Letter
Label
Patient Information Sheet
|
|
3/22/2006
| 035 | New or Modified Indication |
Letter
Label
|
|
11/5/2005
| 034 | Labeling Revision |
Letter
|
|
8/11/2005
| 033 | Labeling Revision |
Letter
Label
|
|
1/6/2005
| 031 | Labeling Revision |
Letter
|
|
8/18/2004
| 029 | New or Modified Indication |
Letter
Label
Review
|
|
5/19/2004
| 028 | New or Modified Indication |
Letter
Label
Review
|
|
1/3/2003
| 022 | Labeling Revision |
Letter
Label
|
|
7/30/2002
| 019 | Labeling Revision |
Letter
Label
|
|
11/27/2002
| 018 | New or Modified Indication |
Letter
Label
Review
|
|
7/9/2002
| 017 | Labeling Revision |
Letter
Label
|
|
4/24/2003
| 016 | Labeling Revision |
Letter
Label
|
|
11/30/2000
| 015 | Manufacturing Change or Addition |
|
|
9/28/2000
| 014 | Control Supplement |
|
|
9/28/2000
| 013 | Manufacturing Change or Addition |
|
|
12/23/1999
| 011 | New or Modified Indication |
Letter
Label
Review
|
|
3/31/1999
| 010 | Manufacturing Change or Addition |
|
|
5/18/1999
| 009 | Control Supplement |
|
|
12/6/1999
| 008 | Control Supplement |
|
|
2/23/1999
| 007 | Manufacturing Change or Addition |
|
|
6/22/1998
| 006 | Labeling Revision |
Letter
|
|
6/22/1998
| 005 | Accelerated Approval |
Letter
Label
|
|
1/6/1998
| 004 | Labeling Revision |
Review
|
|
5/15/1998
| 003 | Manufacturing Change or Addition |
|
|
11/22/1999
| 002 | Formulation Revision |
|
|
4/28/1997
| 001 | Control Supplement |
|
|
5/14/1996
| 000 | Approval |
Label
|