| Action Date | Supplement Number | Approval Type | Letters, Reviews, Labels, Patient Package Insert |
|
12/17/2003
| 055 | Manufacturing Change or Addition |
Letter
|
|
2/12/2002
| 054 | Labeling Revision |
Letter
Review
|
|
11/8/1999
| 052 | Manufacturing Change or Addition |
|
|
7/21/1997
| 051 | Labeling Revision |
|
|
5/24/1996
| 050 | Labeling Revision |
|
|
1/26/1996
| 049 | Control Supplement |
|
|
12/15/1992
| 048 | Labeling Revision |
|
|
9/11/1990
| 046 | Control Supplement |
|
|
8/23/1989
| 043 | Control Supplement |
|
|
3/10/1992
| 042 | Package Change |
|
|
12/12/1991
| 040 | New or Modified Indication |
Label
|
|
8/31/1988
| 039 | New or Modified Indication |
|
|
4/5/1989
| 038 | Control Supplement |
|
|
5/23/1988
| 036 | Formulation Revision |
|
|
8/30/1988
| 035 | Labeling Revision |
|
|
1/30/1987
| 034 | Practioner Draft Labeling |
|
|
1/30/1987
| 033 | New Route of Administration |
|
|
1/30/1987
| 032 | New Dosage Regimen |
|
|
6/28/1984
| 031 | Formulation Revision |
|
|
2/22/1984
| 030 | Control Supplement |
|
|
3/29/1983
| 029 | Labeling Revision |
|
|
3/27/1981
| 027 | Labeling Revision |
|
|
1/27/1981
| 026 | Manufacturing Change or Addition |
|
|
12/22/1980
| 025 | Formulation Revision |
|
|
12/19/1980
| 024 | Formulation Revision |
|
|
9/4/1980
| 023 | Manufacturing Change or Addition |
|
|
2/5/1980
| 022 | Package Change |
|
|
1/16/1980
| 021 | Control Supplement |
|
|
4/28/1980
| 020 | Control Supplement |
|
|
7/25/1979
| 019 | Formulation Revision |
|
|
9/7/1979
| 018 | Manufacturing Change or Addition |
|
|
3/6/1979
| 017 | Control Supplement |
|
|
3/6/1979
| 016 | Formulation Revision |
|
|
3/9/1979
| 015 | Control Supplement |
|
|
11/11/1977
| 014 | Control Supplement |
|
|
8/15/1977
| 013 | Control Supplement |
|
|
6/20/1952
| 000 | Approval |
Label
|