| Action Date | Supplement Number | Approval Type | Letters, Reviews, Labels, Patient Package Insert |
|
10/1/2007
| 076 | Labeling Revision |
Letter
|
|
3/25/2005
| 065 | Manufacturing Change or Addition |
Letter
|
|
12/27/2004
| 062 | Labeling Revision |
Letter
|
|
3/5/2004
| 058 | Labeling Revision |
Letter
|
|
11/20/2002
| 054 | Manufacturing Change or Addition |
|
|
8/5/2002
| 053 | Manufacturing Change or Addition |
|
|
12/19/2000
| 052 | Control Supplement |
|
|
9/8/1998
| 051 | Control Supplement |
|
|
12/23/2002
| 049 | Labeling Revision |
Letter
|
|
8/18/1995
| 046 | Manufacturing Change or Addition |
|
|
11/4/1994
| 045 | Manufacturing Change or Addition |
|
|
8/18/1995
| 044 | Control Supplement |
|
|
6/15/1995
| 043 | Labeling Revision |
Review
|
|
11/28/1995
| 042 | Control Supplement |
|
|
9/30/1994
| 041 | Package Change |
|
|
10/20/1992
| 040 | Control Supplement |
|
|
12/23/2002
| 039 | Labeling Revision |
Letter
|
|
9/30/1992
| 038 | Manufacturing Change or Addition |
|
|
12/11/1992
| 037 | Package Change |
|
|
6/1/1994
| 036 | Labeling Revision |
|
|
6/1/1994
| 035 | Package Change |
|
|
3/1/1993
| 034 | Package Change |
|
|
3/1/1993
| 033 | Labeling Revision |
|
|
3/1/1993
| 032 | Control Supplement |
|
|
3/1/1993
| 031 | Manufacturing Change or Addition |
|
|
12/4/1995
| 030 | Control Supplement |
|
|
8/24/1990
| 029 | Package Change |
|
|
7/13/1993
| 028 | New Route of Administration |
Review
|
|
3/26/1992
| 027 | Control Supplement |
|
|
11/30/1989
| 026 | Patient Population Altered |
|
|
5/3/1989
| 024 | Labeling Revision |
|
|
7/28/1989
| 023 | New or Modified Indication |
|
|
7/28/1989
| 022 | Patient Population Altered |
|
|
6/30/1989
| 021 | New or Modified Indication |
|
|
6/30/1989
| 020 | New or Modified Indication |
|
|
1/4/1989
| 019 | Control Supplement |
|
|
3/31/1989
| 018 | New or Modified Indication |
|
|
11/30/1988
| 017 | New or Modified Indication |
|
|
4/18/1988
| 016 | Manufacturing Change or Addition |
|
|
5/24/1988
| 015 | New or Modified Indication |
|
|
7/29/1988
| 014 | New or Modified Indication |
|
|
1/27/1988
| 013 | Control Supplement |
|
|
2/1/1988
| 012 | Patient Population Altered |
|
|
5/22/1989
| 010 | Manufacturing Change or Addition |
|
|
5/12/1987
| 009 | New or Modified Indication |
|
|
12/23/1993
| 008 | Manufacturing Change or Addition |
|
|
6/4/1987
| 007 | Package Change |
|
|
5/27/1987
| 006 | Labeling Revision |
|
|
4/21/1987
| 004 | Labeling Revision |
|
|
11/20/1986
| 003 | Labeling Revision |
|
|
2/5/1987
| 002 | Manufacturing Change or Addition |
|
|
11/26/1986
| 001 | New or Modified Indication |
|
|
12/26/1985
| 000 | Approval |
|