| Action Date | Supplement Number | Approval Type | Letters, Reviews, Labels, Patient Package Insert |
|
2/2/2007
| 050 | Labeling Revision |
Letter
|
|
10/18/2006
| 049 | Labeling Revision |
Letter
|
|
6/16/2006
| 047 | Labeling Revision |
Letter
|
|
10/5/2005
| 046 | Labeling Revision |
Letter
|
|
3/2/2004
| 044 | Labeling Revision |
Letter
|
|
5/29/2003
| 043 | Patient Population Altered |
Letter Label Review
|
|
8/23/2001
| 042 | Manufacturing Change or Addition |
|
|
4/26/2001
| 041 | Manufacturing Change or Addition |
|
|
5/5/2004
| 040 | Labeling Revision |
Letter
|
|
6/9/2000
| 039 | Manufacturing Change or Addition |
|
|
8/7/2001
| 038 | Labeling Revision |
|
|
3/15/1999
| 037 | Manufacturing Change or Addition |
|
|
2/17/1999
| 036 | Labeling Revision |
Review
|
|
9/3/1996
| 035 | Labeling Revision |
|
|
11/1/1995
| 034 | Control Supplement |
|
|
9/28/1995
| 033 | Labeling Revision |
|
|
6/26/1995
| 032 | Control Supplement |
|
|
9/28/1995
| 031 | Labeling Revision |
|
|
6/8/1995
| 030 | Manufacturing Change or Addition |
|
|
3/21/1995
| 029 | Control Supplement |
|
|
2/22/1995
| 028 | Labeling Revision |
|
|
11/24/1995
| 027 | New or Modified Indication |
|
|
7/24/1994
| 026 | Labeling Revision |
|
|
3/10/1994
| 025 | Labeling Revision |
|
|
9/23/1993
| 024 | Labeling Revision |
|
|
1/28/1994
| 023 | Formulation Revision |
|
|
5/11/1994
| 022 | Labeling Revision |
|
|
1/14/1994
| 021 | Labeling Revision |
|
|
3/10/1993
| 020 | Labeling Revision |
|
|
9/3/1996
| 019 | Labeling Revision |
|
|
9/30/1992
| 018 | Labeling Revision |
|
|
5/13/1992
| 017 | Labeling Revision |
|
|
5/7/1992
| 016 | Labeling Revision |
|
|
1/23/1992
| 015 | Package Change |
|
|
9/30/1992
| 014 | Package Change |
|
|
9/9/1991
| 012 | Control Supplement |
|
|
3/28/1991
| 011 | Labeling Revision |
|
|
2/6/1991
| 010 | Labeling Revision |
|
|
1/7/1991
| 009 | Control Supplement |
|
|
4/11/1990
| 008 | Labeling Revision |
|
|
6/14/1993
| 007 | New or Modified Indication |
|
|
8/9/1989
| 006 | Labeling Revision |
|
|
1/31/1989
| 005 | Labeling Revision |
|
|
3/29/1989
| 004 | Labeling Revision |
|
|
8/19/1988
| 003 | Control Supplement |
|
|
10/25/1988
| 002 | Labeling Revision |
|
|
10/25/1988
| 001 | Labeling Revision |
|
|
12/29/1987
| 000 | Approval |
Letter Label Other Important Information from FDA
|