| Action Date | Supplement Number | Approval Type | Letters, Reviews, Labels, Patient Package Insert |
|
2/21/2007
| 035 | Labeling Revision |
Letter
|
|
1/3/2007
| 034 | Labeling Revision |
Letter
|
|
6/9/2004
| 030 | Labeling Revision |
Letter
|
|
2/6/2002
| 029 | Labeling Revision |
|
|
3/31/2000
| 028 | Manufacturing Change or Addition |
|
|
8/22/1999
| 027 | Labeling Revision |
|
|
11/7/1997
| 026 | Labeling Revision |
|
|
4/17/1990
| 025 | Control Supplement |
|
|
2/9/1990
| 024 | Formulation Revision |
|
|
7/10/1989
| 023 | Expiration Date Change |
|
|
6/5/1989
| 022 | Manufacturing Change or Addition |
|
|
4/10/1989
| 021 | Control Supplement |
|
|
1/25/1989
| 020 | Package Change |
|
|
8/8/1988
| 019 | Control Supplement |
|
|
5/25/1988
| 018 | Package Change |
|
|
1/20/1987
| 017 | Package Change |
|
|
9/2/1986
| 016 | Control Supplement |
|
|
5/27/1986
| 015 | Formulation Revision |
|
|
3/18/1987
| 013 | New Dosage Regimen |
|
|
3/4/1986
| 012 | Manufacturing Change or Addition |
|
|
11/20/1985
| 011 | Control Supplement |
|
|
4/2/1985
| 010 | Manufacturing Change or Addition |
|
|
1/7/1986
| 009 | Control Supplement |
|
|
8/20/1985
| 008 | General Efficacy (MarkIV) |
|
|
3/21/1985
| 006 | Labeling Revision |
|
|
8/9/1984
| 005 | Expiration Date Change |
|
|
10/11/1984
| 004 | Control Supplement |
|
|
3/6/1984
| 002 | Manufacturing Change or Addition |
|
|
1/9/1984
| 001 | General Efficacy (MarkIV) |
|
|
4/19/1983
| 000 | Approval |
|