| Action Date | Supplement Number | Approval Type | Letters, Reviews, Labels, Patient Package Insert |
|
9/20/2007
| 079 | Labeling Revision |
Letter Label
|
|
9/20/2007
| 077 | Labeling Revision |
Letter Label
|
|
8/1/2007
| 075 | Labeling Revision |
Letter Label
|
|
10/20/2006
| 072 | Labeling Revision |
Letter Label
|
|
9/14/2006
| 071 | Labeling Revision |
Letter Label
|
|
2/7/2007
| 069 | Labeling Revision |
Letter Label
|
|
3/2/2006
| 066 | Package Change |
Letter
|
|
1/12/2006
| 064 | Labeling Revision |
Letter
|
|
1/12/2006
| 062 | Labeling Revision |
Letter
|
|
11/29/2005
| 059 | Patient Population Altered |
Letter Label
|
|
2/18/2005
| 058 | Labeling Revision |
Letter
|
|
11/18/2005
| 057 | New or Modified Indication |
Letter Label
|
|
2/24/2006
| 056 | Labeling Revision |
Letter
|
|
8/1/2007
| 055 | Labeling Revision |
Label
|
|
11/18/2005
| 054 | New or Modified Indication |
Letter Label
|
|
5/13/2004
| 052 | Labeling Revision |
Letter Label
|
|
3/19/2004
| 050 | Labeling Revision |
Letter
|
|
5/13/2004
| 048 | Labeling Revision |
Letter Label
|
|
4/8/2004
| 046 | Labeling Revision |
Letter
|
|
3/16/2004
| 045 | Labeling Revision |
Letter
|
|
9/2/2003
| 043 | Labeling Revision |
Letter Review
|
|
5/13/2004
| 041 | Labeling Revision |
Letter Label
|
|
3/19/2004
| 039 | Labeling Revision |
Letter
|
|
9/2/2003
| 038 | Labeling Revision |
Letter Review
|
|
1/31/2003
| 034 | Supplement |
Review
|
|
2/26/2003
| 032 | Labeling Revision |
Letter Review
|
|
5/5/2004
| 030 | Patient Population Altered |
Letter
|
|
10/22/2002
| 029 | Labeling Revision |
Letter Review
|
|
11/19/2002
| 028 | Control Supplement |
|
|
1/31/2003
| 027 | Supplement |
Review
|
|
1/31/2003
| 026 | Supplement |
Review
|
|
8/7/2002
| 025 | Manufacturing Change or Addition |
|
|
10/23/2001
| 024 | Control Supplement |
|
|
1/31/2003
| 023 | Supplement |
Review
|
|
2/11/2003
| 022 | New or Modified Indication |
Letter Label
|
|
1/31/2003
| 021 | Supplement |
Review
|
|
12/13/2000
| 019 | Package Change |
|
|
1/31/2003
| 018 | Supplement |
Review
|
|
10/31/2000
| 017 | Manufacturing Change or Addition |
|
|
5/2/2001
| 016 | New or Modified Indication |
Letter Label Review
|
|
5/2/2001
| 015 | New or Modified Indication |
Letter Label Review
|
|
1/31/2003
| 014 | Supplement |
Review
|
|
7/20/2000
| 013 | Manufacturing Change or Addition |
|
|
6/12/2000
| 012 | Labeling Revision |
|
|
2/25/2000
| 011 | Manufacturing Change or Addition |
|
|
3/9/2000
| 010 | Manufacturing Change or Addition |
Review
|
|
3/9/2000
| 009 | Manufacturing Change or Addition |
|
|
3/3/2000
| 008 | Labeling Revision |
|
|
7/13/2000
| 007 | Efficacy Supplement with Clinical Data to Support |
|
|
12/21/1999
| 006 | Manufacturing Change or Addition |
|
|
8/22/2001
| 005 | Manufacturing Change or Addition |
|
|
5/8/1998
| 002 | Manufacturing Change or Addition |
|
|
3/11/1999
| 001 | New or Modified Indication |
Letter Label
|
|
10/20/1997
| 000 | Approval |
Other Important Information from FDA
|