| Action Date | Supplement Number | Approval Type | Letters, Reviews, Labels, Patient Package Insert |
|
11/16/2005
| 032 | Labeling Revision |
Letter
Label
|
|
10/11/2005
| 031 | Labeling Revision |
Letter
Label
|
|
2/2/2005
| 030 | Labeling Revision |
Letter
Label
|
|
3/24/2004
| 029 | Labeling Revision |
Letter
|
|
1/9/2004
| 028 | Labeling Revision |
Letter
Review
|
|
7/12/2002
| 026 | Efficacy Supplement with Clinical Data to Support |
Letter
|
|
2/12/2002
| 025 | Manufacturing Change or Addition |
|
|
8/20/2001
| 024 | New Dosage Regimen |
Letter
Label
Review
|
|
11/15/2001
| 023 | Control Supplement |
|
|
1/3/2002
| 022 | Manufacturing Change or Addition |
|
|
3/7/2001
| 021 | Control Supplement |
|
|
10/9/2003
| 020 | Labeling Revision |
Letter
|
|
3/31/2000
| 019 | Control Supplement |
|
|
4/28/2000
| 018 | Manufacturing Change or Addition |
|
|
9/22/1998
| 016 | Labeling Revision |
Letter
Review
|
|
9/22/1998
| 015 | Labeling Revision |
Letter
Review
|
|
9/10/1998
| 014 | Manufacturing Change or Addition |
|
|
10/5/1998
| 013 | Manufacturing Change or Addition |
|
|
7/16/1996
| 011 | New or Modified Indication |
|
|
9/1/1995
| 009 | New or Modified Indication |
|
|
12/8/1994
| 008 | Control Supplement |
|
|
9/21/1994
| 007 | New or Modified Indication |
|
|
4/17/1995
| 006 | Control Supplement |
|
|
6/9/1993
| 005 | Labeling Revision |
Review
|
|
4/15/1994
| 004 | New Dosage Regimen |
Letter
Label
Review
|
|
7/21/1992
| 003 | Labeling Revision |
Review
|
|
5/6/1993
| 002 | Control Supplement |
Review
|
|
5/6/1993
| 001 | Formulation Revision |
Review
|
|
10/31/1991
| 000 | Approval |
Letter
Label
Review
|