| Action Date | Supplement Number | Approval Type | Letters, Reviews, Labels, Patient Package Insert |
|
9/4/2007
| 043 | Labeling Revision |
Letter
Label
|
|
9/13/2006
| 039 | Labeling Revision |
Letter
|
|
1/21/2005
| 033 | Labeling Revision |
Letter
Label
|
|
10/29/2002
| 027 | Manufacturing Change or Addition |
|
|
11/5/2001
| 025 | Manufacturing Change or Addition |
|
|
4/18/2001
| 023 | Manufacturing Change or Addition |
|
|
11/14/2000
| 022 | Control Supplement |
|
|
10/24/2000
| 021 | Manufacturing Change or Addition |
|
|
11/10/1999
| 020 | Manufacturing Change or Addition |
|
|
2/5/1999
| 019 | Manufacturing Change or Addition |
|
|
3/10/2000
| 018 | Labeling Revision |
|
|
10/26/1998
| 016 | Package Change |
|
|
9/25/1997
| 015 | Control Supplement |
|
|
3/14/1996
| 013 | Control Supplement |
|
|
3/14/1996
| 012 | Control Supplement |
|
|
11/16/1995
| 011 | Control Supplement |
|
|
3/3/1995
| 010 | Control Supplement |
|
|
2/28/1996
| 009 | Patient Population Altered |
|
|
8/17/1993
| 008 | New or Modified Indication |
|
|
8/22/1990
| 007 | Labeling Revision |
|
|
2/12/1992
| 006 | Formulation Revision |
|
|
8/10/1989
| 005 | Patient Population Altered |
|
|
2/2/1989
| 004 | Labeling Revision |
|
|
3/23/1989
| 003 | Control Supplement |
|
|
4/28/1989
| 001 | New or Modified Indication |
|
|
6/2/1988
| 000 | Approval |
Other Important Information from FDA
|