| Action Date | Supplement Number | Approval Type | Letters, Reviews, Labels, Patient Package Insert |
|
8/14/2007
| 031 | Labeling Revision |
Letter
Label
|
|
9/6/2007
| 030 | Labeling Revision |
Letter
Label
|
|
9/28/2006
| 029 | Labeling Revision |
Letter
|
|
11/4/2006
| 028 | Labeling Revision |
Letter
Label
|
|
8/30/2006
| 027 | Labeling Revision |
Letter
Label
|
|
2/25/2007
| 026 | Efficacy Supplement with Clinical Data to Support |
Letter
Label
|
|
7/20/2004
| 024 | Labeling Revision |
Letter
Label
|
|
8/3/2004
| 023 | Supplement |
Letter
Label
|
|
6/11/2003
| 021 | Labeling Revision |
Letter
Label
|
|
11/26/2003
| 020 | Efficacy Supplement with Clinical Data to Support |
Letter
Label
Review
|
|
12/3/2002
| 018 | Package Change |
Letter
|
|
1/21/2003
| 017 | Efficacy Supplement with Clinical Data to Support |
Letter
|
|
1/7/2002
| 016 | Labeling Revision |
Letter
|
|
2/28/2002
| 015 | Control Supplement |
|
|
8/3/2001
| 014 | Manufacturing Change or Addition |
|
|
10/1/2002
| 013 | Control Supplement |
|
|
5/22/2001
| 012 | Manufacturing Change or Addition |
Review
|
|
7/2/2001
| 011 | Labeling Revision |
|
|
7/12/2002
| 010 | Efficacy Supplement with Clinical Data to Support |
Letter
Label
Review
|
|
7/6/2001
| 009 | Manufacturing Change or Addition |
|
|
7/6/2001
| 008 | Manufacturing Change or Addition |
Review
|
|
4/25/2001
| 007 | Manufacturing Change or Addition |
|
|
11/3/2000
| 006 | Manufacturing Change or Addition |
|
|
7/26/2000
| 005 | Manufacturing Change or Addition |
Review
|
|
10/25/2000
| 004 | Control Supplement |
|
|
4/11/2000
| 003 | Manufacturing Change or Addition |
Review
|
|
2/25/2000
| 002 | Control Supplement |
Review
|
|
2/25/2000
| 001 | Package Change |
Review
|
|
7/15/1999
| 000 | Approval |
Letter
Label
Review
Other Important Information from FDA
|