| Action Date | Supplement Number | Approval Type | Letters, Reviews, Labels, Patient Package Insert |
|
8/22/2006
| 039 | Labeling Revision |
Letter Label
|
|
12/27/2005
| 037 | Labeling Revision |
Label
|
|
3/25/2005
| 035 | Patient Population Altered |
Letter Label
|
|
11/24/2004
| 034 | Labeling Revision |
Letter Label
|
|
12/8/2000
| 032 | Labeling Revision |
|
|
12/8/2000
| 031 | Labeling Revision |
|
|
4/11/2000
| 030 | Labeling Revision |
|
|
5/14/1999
| 029 | Manufacturing Change or Addition |
|
|
2/17/1999
| 028 | Labeling Revision |
|
|
3/10/1999
| 027 | Labeling Revision |
|
|
8/12/1997
| 024 | Manufacturing Change or Addition |
|
|
4/2/1997
| 023 | Labeling Revision |
|
|
10/31/1997
| 022 | New Route of Administration |
Review
|
|
3/12/1996
| 021 | Labeling Revision |
|
|
5/16/1996
| 020 | New or Modified Indication |
|
|
7/29/1996
| 019 | Package Change |
|
|
2/14/1995
| 018 | Manufacturing Change or Addition |
|
|
4/27/1994
| 016 | Labeling Revision |
|
|
3/31/1994
| 015 | Manufacturing Change or Addition |
|
|
1/31/1995
| 014 | Formulation Revision |
|
|
4/28/1993
| 013 | Labeling Revision |
|
|
2/9/1993
| 012 | Control Supplement |
|
|
3/24/1993
| 011 | Control Supplement |
|
|
1/22/1993
| 010 | Control Supplement |
|
|
12/10/1993
| 009 | Formulation Revision |
|
|
2/2/1993
| 008 | Labeling Revision |
|
|
2/2/1993
| 007 | Labeling Revision |
|
|
8/18/1992
| 006 | Control Supplement |
|
|
8/13/1993
| 005 | New or Modified Indication |
|
|
2/2/1993
| 004 | Labeling Revision |
|
|
2/2/1993
| 003 | New Dosage Regimen |
|
|
2/2/1993
| 002 | Labeling Revision |
|
|
2/2/1993
| 001 | Labeling Revision |
|
|
1/4/1991
| 000 | Approval |
Other Important Information from FDA
|