| Action Date | Supplement Number | Approval Type | Letters, Reviews, Labels, Patient Package Insert |
|
12/12/2002
| 042 | Package Change |
|
|
3/5/2003
| 041 | Labeling Revision |
Letter
|
|
5/23/2001
| 040 | Control Supplement |
|
|
4/10/2001
| 039 | Manufacturing Change or Addition |
|
|
3/4/2002
| 038 | Labeling Revision |
Letter Review
|
|
3/4/2002
| 037 | Labeling Revision |
Letter Review
|
|
6/20/2000
| 036 | New Dosage Regimen |
Letter Label Review
|
|
8/29/2002
| 035 | Labeling Revision |
Letter
|
|
10/25/1999
| 033 | New or Modified Indication |
Letter Label
|
|
12/10/1999
| 032 | Labeling Revision |
|
|
1/8/1999
| 031 | Labeling Revision |
Review
|
|
3/19/1999
| 030 | Control Supplement |
|
|
11/5/1998
| 029 | Manufacturing Change or Addition |
|
|
4/9/1998
| 028 | Labeling Revision |
Letter Label Review
|
|
4/9/1998
| 027 | Labeling Revision |
Letter Label Review
|
|
4/9/1998
| 026 | New or Modified Indication |
Letter Label Review
|
|
12/19/1997
| 025 | Control Supplement |
|
|
6/30/1998
| 024 | New or Modified Indication |
Letter Label Review
|
|
4/1/1998
| 023 | Control Supplement |
|
|
8/4/1997
| 022 | New or Modified Indication |
Label
|
|
1/8/1999
| 021 | Labeling Revision |
Review
|
|
4/25/1997
| 019 | Manufacturing Change or Addition |
|
|
9/18/1997
| 018 | Manufacturing Change or Addition |
|
|
3/5/1997
| 017 | Manufacturing Change or Addition |
|
|
1/8/1999
| 016 | Labeling Revision |
Review
|
|
12/13/1996
| 015 | Package Change |
|
|
1/8/1999
| 014 | Labeling Revision |
Review
|
|
4/3/1996
| 013 | Control Supplement |
|
|
4/1/1996
| 012 | Labeling Revision |
|
|
5/5/1995
| 011 | Formulation Revision |
|
|
2/15/1995
| 010 | Control Supplement |
|
|
7/22/1994
| 009 | Manufacturing Change or Addition |
|
|
10/19/1994
| 008 | Manufacturing Change or Addition |
|
|
4/21/1994
| 007 | Control Supplement |
|
|
3/16/1994
| 005 | Manufacturing Change or Addition |
|
|
4/13/1994
| 004 | New or Modified Indication |
Label
|
|
6/22/1994
| 003 | New Dosage Regimen |
Label
|
|
7/23/1993
| 002 | Labeling Revision |
|
|
6/25/1993
| 001 | Manufacturing Change or Addition |
|
|
12/29/1992
| 000 | Approval |
Label
|