| Action Date | Supplement Number | Approval Type | Letters, Reviews, Labels, Patient Package Insert |
|
10/4/2007
| 053 | Labeling Revision |
Letter
|
|
7/16/2007
| 052 | Labeling Revision |
Letter
|
|
6/16/2006
| 050 | Labeling Revision |
Letter
|
|
5/24/2005
| 049 | Labeling Revision |
Letter
|
|
7/1/2003
| 044 | Patient Population Altered |
Letter
Label
Review
|
|
3/30/2004
| 043 | Labeling Revision |
Letter
|
|
7/1/2003
| 042 | Approval |
Letter
Label
Review
|
|
12/15/2000
| 041 | Manufacturing Change or Addition |
|
|
12/19/2000
| 040 | Manufacturing Change or Addition |
|
|
7/27/2000
| 039 | Manufacturing Change or Addition |
|
|
11/18/1999
| 038 | Control Supplement |
|
|
2/7/2000
| 037 | New or Modified Indication |
Letter
Review
|
|
2/24/1999
| 036 | Manufacturing Change or Addition |
|
|
1/20/1999
| 035 | Manufacturing Change or Addition |
Review
|
|
11/6/1998
| 034 | Manufacturing Change or Addition |
Review
|
|
5/1/1998
| 033 | Labeling Revision |
Review
|
|
1/8/1997
| 032 | Labeling Revision |
Review
|
|
10/11/1996
| 031 | Package Change |
Review
|
|
11/15/1995
| 030 | Labeling Revision |
Review
|
|
10/26/1995
| 028 | Manufacturing Change or Addition |
|
|
7/11/1995
| 027 | Package Change |
Review
|
|
7/11/1995
| 026 | Control Supplement |
Review
|
|
3/31/1995
| 025 | Labeling Revision |
|
|
6/5/1995
| 024 | Manufacturing Change or Addition |
Review
|
|
11/24/1995
| 023 | New or Modified Indication |
|
|
5/17/1994
| 022 | Manufacturing Change or Addition |
|
|
8/5/1994
| 021 | Labeling Revision |
|
|
6/13/1995
| 020 | Labeling Revision |
|
|
9/23/1993
| 019 | Labeling Revision |
|
|
3/31/1993
| 018 | Labeling Revision |
Review
|
|
5/26/1993
| 017 | Manufacturing Change or Addition |
Review
|
|
4/29/1993
| 016 | Formulation Revision |
|
|
11/18/1992
| 015 | Manufacturing Change or Addition |
Review
|
|
6/25/1992
| 014 | Labeling Revision |
|
|
2/12/1992
| 013 | Control Supplement |
Review
|
|
12/11/1991
| 012 | Manufacturing Change or Addition |
Review
|
|
7/29/1991
| 011 | Control Supplement |
Review
|
|
4/11/1991
| 010 | Labeling Revision |
|
|
10/17/1990
| 009 | Labeling Revision |
Review
|
|
11/8/1990
| 008 | Control Supplement |
Review
|
|
6/9/1993
| 007 | New or Modified Indication |
|
|
9/5/1989
| 006 | Control Supplement |
Review
|
|
7/20/1989
| 005 | Labeling Revision |
|
|
4/11/1989
| 004 | Labeling Revision |
Review
|
|
1/18/1989
| 003 | Control Supplement |
Review
|
|
9/20/1988
| 002 | Package Change |
Review
|
|
6/30/1988
| 001 | Labeling Revision |
Review
|
|
5/19/1988
| 000 | Approval |
Other Important Information from FDA
|