| Action Date | Supplement Number | Approval Type | Letters, Reviews, Labels, Patient Package Insert |
|
11/1/2006
| 058 | New or Modified Indication |
Letter
Label
|
|
10/26/2006
| 052 | Control Supplement |
Letter
Label
|
|
10/26/2006
| 047 | Labeling Revision |
Letter
Label
|
|
6/28/2006
| 046 | Package Change |
Letter
|
|
10/12/2005
| 045 | Supplement |
Letter
Label
|
|
9/22/2004
| 040 | Labeling Revision |
Letter
Label
|
|
7/25/2003
| 033 | New or Modified Indication |
Letter
Label
Review
|
|
3/24/2003
| 032 | Labeling Revision |
Letter
Review
|
|
12/4/2002
| 031 | Labeling Revision |
Letter
|
|
5/22/2001
| 030 | Manufacturing Change or Addition |
|
|
5/1/2001
| 029 | Control Supplement |
|
|
1/17/2001
| 028 | Control Supplement |
|
|
2/12/2001
| 026 | Labeling Revision |
|
|
6/10/2002
| 025 | Labeling Revision |
Letter
|
|
9/7/1999
| 024 | Manufacturing Change or Addition |
|
|
2/4/1999
| 022 | Formulation Revision |
|
|
10/3/1997
| 021 | Labeling Revision |
|
|
6/13/1997
| 020 | Control Supplement |
|
|
3/11/1997
| 019 | Labeling Revision |
Review
|
|
3/11/1997
| 018 | New or Modified Indication |
Review
|
|
8/5/1996
| 017 | Labeling Revision |
|
|
11/22/1996
| 016 | Control Supplement |
|
|
11/7/1996
| 015 | Labeling Revision |
|
|
12/15/1995
| 014 | Manufacturing Change or Addition |
|
|
8/1/1996
| 013 | New or Modified Indication |
|
|
9/22/1995
| 012 | Labeling Revision |
|
|
9/13/1995
| 011 | Control Supplement |
|
|
1/11/1995
| 010 | Control Supplement |
|
|
4/15/1994
| 009 | New Dosage Regimen |
|
|
11/18/1993
| 008 | Labeling Revision |
|
|
12/14/1993
| 007 | Control Supplement |
|
|
3/18/1992
| 006 | Labeling Revision |
|
|
10/11/1990
| 005 | Labeling Revision |
|
|
4/23/1990
| 004 | Control Supplement |
|
|
4/4/1989
| 003 | Labeling Revision |
|
|
5/10/1989
| 002 | New Route of Administration |
|
|
6/23/1987
| 001 | Formulation Revision |
|
|
3/8/1987
| 000 | Approval |
|