| Action Date | Supplement Number | Approval Type | Letters, Reviews, Labels, Patient Package Insert |
|
7/16/2003
| 029 | Supplement |
Letter
|
|
7/16/2003
| 026 | Labeling Revision |
Letter
|
|
10/16/2002
| 021 | Manufacturing Change or Addition |
|
|
10/8/2002
| 020 | Control Supplement |
|
|
10/7/2002
| 019 | Control Supplement |
|
|
7/15/2002
| 017 | Control Supplement |
|
|
3/25/2004
| 015 | Formulation Revision |
Letter Label
|
|
7/23/2001
| 014 | Control Supplement |
|
|
3/26/2001
| 013 | Manufacturing Change or Addition |
|
|
10/26/2000
| 012 | Manufacturing Change or Addition |
|
|
11/8/2000
| 011 | Manufacturing Change or Addition |
|
|
8/31/2000
| 010 | Manufacturing Change or Addition |
|
|
2/28/2001
| 009 | Control Supplement |
|
|
1/5/2000
| 008 | Control Supplement |
|
|
11/22/1999
| 007 | Control Supplement |
|
|
5/24/2000
| 006 | New or Modified Indication |
Letter Review
|
|
1/5/2000
| 005 | Control Supplement |
|
|
6/23/1999
| 004 | Manufacturing Change or Addition |
|
|
5/25/2000
| 003 | Control Supplement |
|
|
11/10/1998
| 002 | Control Supplement |
|
|
9/18/1998
| 001 | Manufacturing Change or Addition |
|
|
9/29/1997
| 000 | Approval |
|