| Action Date | Supplement Number | Approval Type | Letters, Reviews, Labels, Patient Package Insert |
|
8/27/2007
| 044 | Labeling Revision |
Letter
Letter
Label
Label
|
|
8/30/2007
| 044 | Labeling Revision |
Letter
Letter
Label
Label
|
|
7/13/2007
| 040 | Labeling Revision |
Letter
Label
|
|
11/27/2006
| 035 | Control Supplement |
Letter
Label
|
|
9/21/2006
| 034 | Control Supplement |
Letter
Label
|
|
8/24/2005
| 031 | Labeling Revision |
Letter
Label
|
|
7/9/2004
| 030 | Package Change |
Letter
Label
|
|
2/11/2005
| 029 | Formulation Revision |
Letter
Label
|
|
8/29/2003
| 027 | Accelerated Approval |
Letter
Label
|
|
12/1/2003
| 026 | Labeling Revision |
Letter
Label
Review
|
|
10/17/2002
| 023 | Control Supplement |
|
|
12/31/2002
| 022 | Manufacturing Change or Addition |
|
|
12/20/2002
| 021 | Manufacturing Change or Addition |
|
|
12/3/2001
| 020 | Control Supplement |
|
|
11/19/2001
| 019 | Control Supplement |
|
|
9/6/2002
| 018 | Control Supplement |
|
|
7/19/2001
| 017 | Manufacturing Change or Addition |
|
|
9/6/2001
| 016 | Labeling Revision |
|
|
5/3/2001
| 015 | Manufacturing Change or Addition |
|
|
6/13/2001
| 014 | Labeling Revision |
|
|
8/17/2000
| 013 | Control Supplement |
|
|
7/19/2000
| 012 | Control Supplement |
|
|
4/11/2000
| 011 | Manufacturing Change or Addition |
|
|
10/27/2000
| 010 | Labeling Revision |
|
|
7/17/2000
| 009 | Labeling Revision |
|
|
9/18/2000
| 008 | Expiration Date Change |
|
|
3/28/2000
| 007 | Manufacturing Change or Addition |
|
|
4/4/2000
| 006 | Labeling Revision |
|
|
7/9/1998
| 005 | Control Supplement |
|
|
7/9/1998
| 004 | Manufacturing Change or Addition |
|
|
1/21/1998
| 003 | Manufacturing Change or Addition |
|
|
7/25/1997
| 002 | Control Supplement |
|
|
1/16/1998
| 001 | Labeling Revision |
|
|
8/23/1996
| 000 | Approval |
|