| Action Date | Supplement Number | Approval Type | Letters, Reviews, Labels, Patient Package Insert |
|
10/12/2005
| 025 | Labeling Revision |
Letter
Label
|
|
7/15/2004
| 022 | Labeling Revision |
Letter
|
|
6/16/2003
| 017 | Efficacy Supplement with Clinical Data to Support |
Letter
Label
|
|
2/14/2002
| 016 | Manufacturing Change or Addition |
|
|
1/10/2002
| 015 | Control Supplement |
|
|
7/26/2001
| 014 | Manufacturing Change or Addition |
|
|
6/8/2001
| 013 | Labeling Revision |
Letter
Label
Review
|
|
7/3/2001
| 011 | Manufacturing Change or Addition |
|
|
6/8/2001
| 010 | New Dosage Regimen |
Letter
Label
Review
|
|
5/31/2000
| 009 | Control Supplement |
|
|
6/26/2000
| 008 | Manufacturing Change or Addition |
|
|
3/3/2000
| 007 | Control Supplement |
|
|
12/3/1999
| 006 | Manufacturing Change or Addition |
|
|
4/16/1999
| 005 | Manufacturing Change or Addition |
|
|
7/21/1999
| 004 | Control Supplement |
|
|
7/21/1999
| 003 | Labeling Revision |
|
|
9/20/1999
| 002 | Efficacy Supplement with Clinical Data to Support |
Letter
Label
Review
|
|
9/11/1998
| 001 | Labeling Revision |
|
|
5/18/1998
| 000 | Approval |
Letter
Label
Review
Consumer Information Sheet
|