| Action Date | Supplement Number | Approval Type | Letters, Reviews, Labels, Patient Package Insert |
|
3/17/2006
| 029 | Labeling Revision |
|
|
9/22/2006
| 027 | New or Modified Indication |
Letter Label Label
|
|
9/25/2006
| 027 | Labeling Revision |
Letter Label Label
|
|
9/22/2006
| 026 | New or Modified Indication |
Letter Label Label
|
|
9/25/2006
| 026 | Labeling Revision |
Letter Label Label
|
|
9/22/2006
| 025 | New or Modified Indication |
Letter Label
|
|
9/25/2006
| 025 | Labeling Revision |
Letter Label
|
|
9/22/2006
| 021 | New or Modified Indication |
Letter Label Label
|
|
9/25/2006
| 021 | Labeling Revision |
Letter Label Label
|
|
4/4/2003
| 018 | Labeling Revision |
Letter
|
|
6/20/2003
| 017 | New or Modified Indication |
Letter Label Review
|
|
1/14/2004
| 016 | Efficacy Supplement with Clinical Data to Support |
Letter
|
|
2/23/2001
| 015 | Labeling Revision |
|
|
9/8/2000
| 014 | Labeling Revision |
|
|
6/12/2000
| 012 | Manufacturing Change or Addition |
|
|
5/25/2001
| 011 | Efficacy Supplement with Clinical Data to Support |
Label Review
|
|
9/22/2006
| 010 | New or Modified Indication |
Letter Label Label
|
|
9/25/2006
| 010 | Labeling Revision |
Letter Label Label
|
|
6/8/1999
| 009 | Manufacturing Change or Addition |
|
|
1/17/2003
| 008 | New or Modified Indication |
Label
|
|
5/10/1999
| 007 | Manufacturing Change or Addition |
|
|
3/16/1998
| 006 | Labeling Revision |
|
|
3/16/1998
| 005 | Control Supplement |
|
|
3/11/1997
| 004 | Labeling Revision |
|
|
12/14/1998
| 003 | New or Modified Indication |
Letter Label Review Dear Health Professional Letter
|
|
8/24/1998
| 002 | New or Modified Indication |
Letter Label Review Dear Health Professional Letter
|
|
12/27/1994
| 000 | Approval |
Other Important Information from FDA
|