| Action Date | Supplement Number | Approval Type | Letters, Reviews, Labels, Patient Package Insert |
|
8/2/2007
| 082 | Labeling Revision |
Letter
Label
|
|
8/2/2007
| 081 | Labeling Revision |
Letter
Label
|
|
3/15/2007
| 078 | Labeling Revision |
Letter
|
|
9/20/2006
| 076 | Labeling Revision |
Label
|
|
4/11/2006
| 074 | Labeling Revision |
Letter
|
|
12/1/2005
| 073 | Labeling Revision |
Letter
|
|
2/18/2005
| 072 | Labeling Revision |
Letter
|
|
12/1/2005
| 071 | Labeling Revision |
Letter
|
|
9/3/2004
| 070 | Labeling Revision |
Letter
|
|
8/19/2004
| 069 | Labeling Revision |
Letter
|
|
6/12/2002
| 067 | New Dosage Regimen |
Letter
Label
|
|
7/29/2002
| 065 | Efficacy Supplement with Clinical Data to Support |
|
|
1/3/2003
| 064 | Patient Population Altered |
Letter
Label
Review
|
|
11/28/2000
| 063 | Labeling Revision |
Review
|
|
11/28/2000
| 062 | Labeling Revision |
Review
|
|
11/28/2000
| 060 | Labeling Revision |
Review
|
|
6/16/1999
| 059 | Labeling Revision |
|
|
7/6/2000
| 058 | New or Modified Indication |
Letter
Label
|
|
2/11/1999
| 057 | Manufacturing Change or Addition |
|
|
10/20/1998
| 056 | Control Supplement |
|
|
6/15/1999
| 054 | Formulation Revision |
Review
|
|
5/29/1998
| 053 | Manufacturing Change or Addition |
|
|
10/7/1999
| 052 | Labeling Revision |
Review
|
|
3/13/1998
| 051 | Labeling Revision |
|
|
7/6/1998
| 050 | Manufacturing Change or Addition |
|
|
4/3/1998
| 049 | Package Change |
|
|
9/17/1997
| 046 | Control Supplement |
|
|
12/30/1996
| 043 | Manufacturing Change or Addition |
|
|
9/12/1995
| 040 | Labeling Revision |
|
|
3/1/1995
| 039 | Control Supplement |
|
|
9/12/1995
| 038 | Labeling Revision |
|
|
3/1/1995
| 037 | Labeling Revision |
|
|
3/25/1997
| 036 | Labeling Revision |
Review
|
|
7/6/1994
| 034 | Labeling Revision |
|
|
1/9/1995
| 033 | Manufacturing Change or Addition |
|
|
3/25/1993
| 032 | Labeling Revision |
|
|
8/18/1993
| 031 | Labeling Revision |
|
|
8/20/1992
| 030 | Labeling Revision |
|
|
1/21/1992
| 028 | Labeling Revision |
|
|
1/21/1992
| 027 | Labeling Revision |
|
|
12/23/1992
| 026 | Formulation Revision |
|
|
1/21/1992
| 025 | Labeling Revision |
|
|
4/9/1991
| 024 | Labeling Revision |
|
|
4/9/1991
| 023 | Labeling Revision |
|
|
6/7/1990
| 022 | Labeling Revision |
|
|
6/7/1990
| 021 | Labeling Revision |
|
|
6/7/1990
| 020 | Labeling Revision |
|
|
6/7/1990
| 019 | Labeling Revision |
|
|
6/7/1990
| 018 | Labeling Revision |
|
|
6/7/1990
| 017 | Labeling Revision |
|
|
6/7/1990
| 016 | Labeling Revision |
|
|
6/7/1990
| 015 | Labeling Revision |
|
|
2/8/1989
| 014 | Control Supplement |
|
|
2/16/1989
| 013 | Labeling Revision |
|
|
2/17/1989
| 012 | Control Supplement |
|
|
11/17/1988
| 011 | Labeling Revision |
|
|
11/17/1988
| 009 | Labeling Revision |
|
|
10/26/1988
| 008 | Manufacturing Change or Addition |
|
|
6/22/1988
| 007 | Labeling Revision |
|
|
9/28/1988
| 006 | Package Change |
|
|
11/21/1996
| 004 | New or Modified Indication |
|
|
9/28/1988
| 003 | Control Supplement |
|
|
5/6/1988
| 002 | Control Supplement |
|
|
12/29/1987
| 000 | Approval |
Other Important Information from FDA
|