| Action Date | Supplement Number | Approval Type | Letters, Reviews, Labels, Patient Package Insert |
|
11/1/2006
| 030 | Labeling Revision |
Letter
Label
|
|
3/19/2004
| 027 | Labeling Revision |
Letter
|
|
3/19/2004
| 026 | Labeling Revision |
Letter
|
|
1/8/2002
| 024 | Labeling Revision |
Letter
|
|
2/8/2001
| 022 | Labeling Revision |
|
|
8/4/2000
| 021 | Manufacturing Change or Addition |
|
|
4/19/2001
| 020 | Efficacy Supplement with Clinical Data to Support |
Letter
Review
|
|
12/15/2000
| 019 | Patient Population Altered |
Letter
Label
Review
|
|
6/7/1999
| 018 | Control Supplement |
|
|
9/22/1999
| 017 | Efficacy Supplement with Clinical Data to Support |
Review
|
|
3/12/1999
| 016 | Manufacturing Change or Addition |
|
|
6/1/1999
| 015 | Manufacturing Change or Addition |
|
|
12/4/1998
| 014 | Control Supplement |
|
|
11/18/1998
| 013 | Manufacturing Change or Addition |
|
|
11/5/1998
| 011 | Formulation Revision |
|
|
10/22/1998
| 010 | New or Modified Indication |
Letter
Review
|
|
7/2/1998
| 009 | Manufacturing Change or Addition |
|
|
2/10/1998
| 008 | Labeling Revision |
|
|
5/15/1998
| 007 | Manufacturing Change or Addition |
|
|
11/6/1997
| 006 | Labeling Revision |
Review
|
|
6/6/1997
| 005 | Manufacturing Change or Addition |
|
|
7/26/1996
| 004 | Manufacturing Change or Addition |
|
|
4/30/1996
| 003 | Control Supplement |
|
|
9/13/1995
| 002 | Package Change |
|
|
3/3/1995
| 000 | Approval |
|