| Action Date | Supplement Number | Approval Type | Letters, Reviews, Labels, Patient Package Insert |
|
5/3/2006
| 035 | Labeling Revision |
Letter
|
|
2/18/2005
| 029 | Labeling Revision |
Letter
Label
|
|
12/19/2002
| 026 | Control Supplement |
|
|
10/24/2002
| 024 | Manufacturing Change or Addition |
|
|
8/15/2002
| 023 | Efficacy Supplement with Clinical Data to Support |
Letter
|
|
1/30/2002
| 022 | Labeling Revision |
Letter
|
|
1/18/2002
| 021 | Control Supplement |
|
|
2/8/2001
| 020 | Manufacturing Change or Addition |
|
|
2/8/2001
| 019 | Manufacturing Change or Addition |
|
|
1/18/2001
| 018 | Manufacturing Change or Addition |
|
|
8/16/2000
| 017 | Manufacturing Change or Addition |
|
|
7/21/2000
| 016 | Control Supplement |
|
|
10/12/2000
| 015 | New or Modified Indication |
Letter
Label
Review
|
|
5/15/2000
| 014 | Manufacturing Change or Addition |
|
|
9/29/1998
| 011 | New Dosage Regimen |
Letter
Label
Review
|
|
2/12/1998
| 009 | Manufacturing Change or Addition |
|
|
12/9/1996
| 005 | Manufacturing Change or Addition |
|
|
5/28/1996
| 004 | Manufacturing Change or Addition |
|
|
4/9/1996
| 003 | Package Change |
|
|
11/14/1994
| 001 | Labeling Revision |
|
|
12/30/1993
| 000 | Approval |
|