| Action Date | Supplement Number | Approval Type | Letters, Reviews, Labels, Patient Package Insert |
|
8/8/2003
| 021 | Labeling Revision |
Letter
|
|
8/29/2003
| 019 | New or Modified Indication |
Letter
Label
|
|
12/18/2002
| 018 | Control Supplement |
|
|
7/3/2002
| 017 | Manufacturing Change or Addition |
|
|
9/9/2002
| 016 | New or Modified Indication |
Letter
|
|
3/14/2002
| 015 | Control Supplement |
|
|
6/1/2001
| 014 | Manufacturing Change or Addition |
|
|
6/25/2001
| 013 | Labeling Revision |
Label
|
|
6/25/2001
| 012 | New Dosage Regimen |
Letter
Label
Review
|
|
4/20/2000
| 011 | Labeling Revision |
|
|
6/25/2001
| 010 | Labeling Revision |
Label
|
|
4/20/2000
| 009 | Labeling Revision |
|
|
7/22/1999
| 008 | Manufacturing Change or Addition |
|
|
2/2/1999
| 007 | Package Change |
|
|
11/25/1998
| 006 | Manufacturing Change or Addition |
|
|
4/1/2003
| 005 | New or Modified Indication |
Letter
Label
|
|
4/30/1997
| 004 | Labeling Revision |
|
|
9/26/1997
| 003 | New or Modified Indication |
Review
|
|
10/18/1996
| 002 | Labeling Revision |
|
|
10/4/1996
| 001 | New or Modified Indication |
|
|
12/15/1995
| 000 | Approval |
|