| Action Date | Supplement Number | Approval Type | Letters, Reviews, Labels, Patient Package Insert |
|
6/1/2007
| 074 | Control Supplement |
Letter
Label
|
|
5/17/2005
| 070 | Labeling Revision |
Letter
Label
|
|
8/31/2005
| 069 | Labeling Revision |
Letter
Label
|
|
2/25/2004
| 068 | Supplement |
Letter
Label
Review
|
|
2/24/2004
| 067 | Labeling Revision |
Letter
Label
Review
|
|
9/17/2003
| 066 | Labeling Revision |
Letter
Label
|
|
9/17/2003
| 065 | Labeling Revision |
Letter
Label
|
|
4/16/2003
| 058 | New or Modified Indication |
Letter
Label
Review
|
|
5/6/2002
| 057 | Control Supplement |
|
|
10/18/2002
| 056 | Patient Population Altered |
Letter
Label
|
|
2/22/2002
| 055 | Manufacturing Change or Addition |
|
|
3/21/2002
| 054 | Package Change |
|
|
11/14/2001
| 053 | Labeling Revision |
Label
|
|
3/21/2002
| 052 | Efficacy Supplement with Clinical Data to Support |
Letter
Label
Review
|
|
5/6/2002
| 051 | Labeling Revision |
Letter
Label
|
|
9/13/2001
| 050 | Control Supplement |
|
|
6/4/2001
| 049 | Control Supplement |
|
|
4/10/2001
| 048 | Manufacturing Change or Addition |
|
|
4/10/2001
| 047 | Manufacturing Change or Addition |
|
|
11/14/2001
| 045 | Labeling Revision |
|
|
12/11/2000
| 044 | Package Change |
|
|
4/14/2000
| 043 | Manufacturing Change or Addition |
|
|
11/7/2000
| 042 | Efficacy Supplement with Clinical Data to Support |
|
|
3/15/2000
| 041 | Control Supplement |
|
|
4/27/2000
| 040 | New Dosage Regimen |
Letter
Label
Review
|
|
8/22/2000
| 039 | Labeling Revision |
|
|
11/22/1999
| 036 | New or Modified Indication |
Review
|
|
9/15/1999
| 035 | Labeling Revision |
|
|
11/22/1999
| 034 | New or Modified Indication |
Review
|
|
3/22/1999
| 033 | Expiration Date Change |
|
|
8/5/1999
| 032 | New or Modified Indication |
Letter
|
|
4/23/1999
| 031 | Labeling Revision |
|
|
9/24/1998
| 030 | Manufacturing Change or Addition |
|
|
6/29/1998
| 029 | Labeling Revision |
Review
|
|
7/10/1998
| 028 | New Dosage Regimen |
Letter
Review
|
|
3/31/1998
| 027 | New or Modified Indication |
Letter
Review
|
|
7/10/1998
| 026 | New or Modified Indication |
Letter
Review
|
|
12/2/1997
| 025 | Control Supplement |
|
|
9/9/1997
| 023 | Control Supplement |
|
|
7/18/1997
| 022 | Manufacturing Change or Addition |
|
|
10/31/1997
| 021 | New or Modified Indication |
|
|
8/12/1997
| 020 | Labeling Revision |
|
|
3/17/1997
| 019 | Control Supplement |
|
|
5/19/1997
| 018 | Labeling Revision |
Review
|
|
5/23/1997
| 017 | Labeling Revision |
|
|
11/22/1996
| 016 | Control Supplement |
|
|
8/1/1995
| 015 | Labeling Revision |
|
|
6/9/1995
| 014 | Labeling Revision |
|
|
11/6/1995
| 013 | Control Supplement |
|
|
8/1/1995
| 012 | Control Supplement |
|
|
6/30/1995
| 011 | New or Modified Indication |
|
|
2/16/1995
| 010 | Labeling Revision |
|
|
12/21/1994
| 009 | Labeling Revision |
|
|
4/19/1995
| 008 | Labeling Revision |
|
|
7/28/1994
| 007 | Manufacturing Change or Addition |
|
|
1/23/1995
| 006 | Labeling Revision |
|
|
2/22/1994
| 005 | Labeling Revision |
|
|
11/24/1993
| 004 | Package Change |
|
|
2/22/1994
| 003 | Labeling Revision |
|
|
8/9/1993
| 002 | Package Change |
|
|
11/27/1992
| 001 | Labeling Revision |
|
|
12/23/1991
| 000 | Approval |
Other Important Information from FDA
|