| Action Date | Supplement Number | Approval Type | Letters, Reviews, Labels, Patient Package Insert |
|
2/15/2007
| 030 | Labeling Revision |
Letter
Label
|
|
2/23/2006
| 026 | Efficacy Supplement with Clinical Data to Support |
Letter
Label
|
|
6/28/2005
| 021 | Labeling Revision |
Letter
Label
Other
Other
|
|
6/28/2005
| 020 | New or Modified Indication |
Letter
Label
Other
Other
|
|
9/17/2001
| 018 | Manufacturing Change or Addition |
|
|
5/2/2001
| 017 | Manufacturing Change or Addition |
|
|
4/13/2000
| 016 | New Dosage Regimen |
Letter
Label
Review
|
|
11/24/1999
| 015 | Labeling Revision |
|
|
11/3/1999
| 014 | Manufacturing Change or Addition |
|
|
12/1/1999
| 013 | Efficacy Supplement with Clinical Data to Support |
Letter
Review
|
|
9/25/1998
| 012 | Control Supplement |
|
|
9/25/1998
| 011 | Control Supplement |
|
|
9/12/1997
| 010 | Control Supplement |
|
|
12/15/1997
| 009 | New or Modified Indication |
|
|
8/7/1996
| 008 | Control Supplement |
|
|
8/21/1995
| 007 | Labeling Revision |
|
|
9/22/1995
| 006 | Control Supplement |
|
|
2/1/1996
| 004 | Manufacturing Change or Addition |
|
|
2/3/1995
| 003 | Manufacturing Change or Addition |
|
|
8/3/1994
| 002 | Manufacturing Change or Addition |
|
|
7/21/1994
| 001 | Manufacturing Change or Addition |
|
|
3/9/1994
| 000 | Approval |
|