05/23/2014 |
066 |
Labeling Revision |
Label (PDF) Letter (PDF) |
|
08/14/2013 |
065 |
Labeling Revision |
Label (PDF) Letter (PDF) |
|
04/27/2012 |
061 |
Efficacy Supplement with Clinical Data to Support |
Label (PDF) Letter (PDF) Review |
|
10/11/2011 |
064 |
Labeling Revision |
Label (PDF) Letter (PDF) Review (PDF) |
|
10/11/2011 |
062 |
Labeling Revision |
Label (PDF) Letter (PDF) Review (PDF) |
|
06/09/2011 |
059 |
Labeling Revision |
Label (PDF) Letter (PDF) |
|
02/25/2011 |
058 |
Labeling Revision |
Label (PDF) Letter (PDF) |
|
04/27/2009 |
053 |
Labeling Revision |
Label (PDF) Letter (PDF) |
|
03/12/2009 |
054 |
Labeling Revision |
Letter (PDF) |
Label is not available on this site. |
10/03/2008 |
052 |
Labeling Revision |
Label (PDF) Letter (PDF) |
|
05/05/2008 |
047 |
Patient Population Altered |
Letter (PDF) Summary Review (PDF) |
Label is not available on this site. |
04/16/2008 |
051 |
Labeling Revision |
Label (PDF) Letter (PDF) |
|
12/13/2007 |
050 |
Labeling Revision |
Label (PDF) Letter (PDF) |
|
11/16/2007 |
049 |
Labeling Revision |
Label (PDF) Letter (PDF) |
|
11/15/2007 |
048 |
Labeling Revision |
Label (PDF) Letter (PDF) |
|
09/14/2007 |
041 |
New Dosage Regimen |
Label (PDF) Letter (PDF) |
|
09/11/2007 |
043 |
Patient Population Altered |
Label (PDF) Letter (PDF) |
|
06/19/2007 |
045 |
Labeling Revision |
Label (PDF) Letter (PDF) |
|
05/31/2007 |
042 |
Labeling Revision |
Label (PDF) Letter (PDF) |
|
05/10/2007 |
044 |
Labeling Revision |
Label (PDF) Letter (PDF) |
|
06/23/2006 |
040 |
Labeling Revision |
Label (PDF) Letter (PDF) |
|
01/20/2006 |
039 |
Labeling Revision |
Label (PDF) |
|
08/04/2005 |
037 |
New Dosage Regimen |
Label (PDF) Letter (PDF) |
|
11/24/2004 |
035 |
New or Modified Indication |
Label (PDF) Letter (PDF) |
|
11/04/2004 |
036 |
Labeling Revision |
Label (PDF) Letter (PDF) |
|
09/14/2004 |
034 |
Labeling Revision |
Label (PDF) Letter (PDF) Review (PDF) |
|
09/14/2004 |
033 |
Labeling Revision |
Label (PDF) Letter (PDF) Review (PDF) |
|
07/14/2004 |
030 |
New or Modified Indication |
Label (PDF) |
|
03/05/2004 |
029 |
Labeling Revision |
Label (PDF) Letter (PDF) |
|
10/23/2003 |
028 |
New Dosage Regimen |
Letter (PDF) Review (PDF) |
Label is not available on this site. |
05/23/2003 |
027 |
New or Modified Indication |
Label (PDF) Letter (PDF) Review (PDF) |
|
10/30/2002 |
025 |
New or Modified Indication |
Letter (PDF) |
Label is not available on this site. |
06/12/2002 |
026 |
Control Supplement |
|
This supplement type does not usually require new labeling. |
04/30/2002 |
024 |
Control Supplement |
|
This supplement type does not usually require new labeling. |
01/11/2002 |
023 |
Control Supplement |
|
This supplement type does not usually require new labeling. |
12/18/2001 |
022 |
Labeling Revision |
Label (PDF) Letter (PDF) Review |
|
12/18/2001 |
021 |
Labeling Revision |
Label (PDF) Letter (PDF) Review |
|
12/18/2001 |
015 |
Labeling Revision |
Label (PDF) Letter (PDF) Review |
|
06/08/2001 |
020 |
Manufacturing Change or Addition |
|
This supplement type does not usually require new labeling. |
02/13/2001 |
019 |
Control Supplement |
|
This supplement type does not usually require new labeling. |
01/04/2001 |
018 |
Manufacturing Change or Addition |
|
This supplement type does not usually require new labeling. |
12/13/2000 |
016 |
Package Change |
|
Label is not available on this site. |
09/15/2000 |
017 |
Control Supplement |
|
This supplement type does not usually require new labeling. |
09/08/2000 |
013 |
New or Modified Indication |
Label (PDF) Letter (PDF) |
|
09/08/2000 |
012 |
Control Supplement |
Label (PDF) Letter (PDF) |
This supplement type does not usually require new labeling. |
08/28/2000 |
014 |
Manufacturing Change or Addition |
|
This supplement type does not usually require new labeling. |
02/11/2000 |
011 |
Control Supplement |
|
This supplement type does not usually require new labeling. |
02/02/2000 |
009 |
Labeling Revision |
Letter (PDF) |
Label is not available on this site. |
02/02/2000 |
008 |
New or Modified Indication |
Letter (PDF) Review |
Label is not available on this site. |
09/29/1999 |
010 |
Control Supplement |
|
This supplement type does not usually require new labeling. |
07/29/1999 |
007 |
Labeling Revision |
|
Label is not available on this site. |
07/29/1999 |
006 |
Labeling Revision |
|
Label is not available on this site. |
07/29/1999 |
005 |
Labeling Revision |
|
Label is not available on this site. |
12/17/1998 |
004 |
New or Modified Indication |
Label (PDF) Letter (PDF) Review |
|
05/11/1998 |
002 |
Manufacturing Change or Addition |
|
This supplement type does not usually require new labeling. |
03/24/1998 |
003 |
Manufacturing Change or Addition |
|
This supplement type does not usually require new labeling. |
01/30/1998 |
001 |
Control Supplement |
|
This supplement type does not usually require new labeling. |
12/20/1996 |
000 |
Approval |
Review |
Label is not available on this site. |
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