| Action Date | Supplement Number | Approval Type | Letters, Reviews, Labels, Patient Package Insert |
|
9/17/2003
| 015 | Labeling Revision |
Letter Review
|
|
10/26/2001
| 013 | Labeling Revision |
|
|
6/25/2001
| 012 | Manufacturing Change or Addition |
|
|
10/31/2000
| 011 | Control Supplement |
|
|
1/16/2001
| 010 | Manufacturing Change or Addition |
|
|
7/26/2000
| 009 | Manufacturing Change or Addition |
|
|
10/26/2000
| 008 | Manufacturing Change or Addition |
|
|
4/17/2000
| 007 | Control Supplement |
|
|
9/5/2001
| 006 | Labeling Revision |
|
|
12/15/1999
| 005 | Package Change |
|
|
11/18/1999
| 004 | Manufacturing Change or Addition |
|
|
8/10/1999
| 003 | Control Supplement |
Review
|
|
4/1/2002
| 002 | Efficacy Supplement with Clinical Data to Support |
Letter Label
|
|
2/4/1998
| 001 | New or Modified Indication |
|
|
4/26/1994
| 000 | Approval |
|