2026-03-18Labeling · Supplement 50 · standard — Letter ↗AP 2021-08-25Labeling · Supplement 49 · standard — Letter ↗AP 2021-06-15Labeling · Supplement 47 · standard — Letter ↗AP 2021-04-13Labeling · Supplement 48 · standard — Letter ↗AP 2015-07-06Manufacturing (CMC) · Supplement 45 · priorityAP
2014-03-11Labeling · Supplement 44 · standard — Label ↗AP 2013-01-16Labeling · Supplement 43 · unknown — Letter ↗AP 2012-04-11Labeling · Supplement 41 · unknown — Label ↗AP 2012-04-11Labeling · Supplement 42 · unknown — Letter ↗AP 2012-04-11Labeling · Supplement 40 · unknown — Letter ↗AP 2011-06-10Labeling · Supplement 35 · unknown — Letter ↗AP 2011-06-09Labeling · Supplement 39 · unknown — Letter ↗AP 2010-10-04Labeling · Supplement 37 · unknown — Label ↗AP 2010-03-23Labeling · Supplement 33 · unknown — Letter ↗AP 2004-04-23Labeling · Supplement 29 · standard — Review ↗AP 2004-04-12Efficacy · Supplement 26 · unknown — Review ↗AP 2003-09-23Labeling · Supplement 20 · standard — Review ↗AP 2003-09-09Labeling · Supplement 27 · standard — Review ↗AP 2003-06-26Labeling · Supplement 25 · standard — Review ↗AP 2002-11-26Manufacturing (CMC) · Supplement 24 · priority — Review ↗AP 2002-10-28Manufacturing (CMC) · Supplement 23 · priority — Review ↗AP 2001-01-30Labeling · Supplement 22 · standard — Review ↗AP 2001-01-17Labeling · Supplement 19 · standard — Review ↗AP 1999-08-02Labeling · Supplement 18 · standard — Review ↗AP 1998-03-20Efficacy · Supplement 15 · standard — Review ↗AP 1998-03-20Efficacy · Supplement 16 · priority — Review ↗AP 1997-12-19Labeling · Supplement 17 · standard — Review ↗AP 1997-05-16Manufacturing (CMC) · Supplement 14 · priority — Review ↗AP 1997-05-12Manufacturing (CMC) · Supplement 13 · priority — Review ↗AP 1996-08-28Labeling · Supplement 11 · standard — Review ↗AP 1996-07-24Manufacturing (CMC) · Supplement 10 · priority — Review ↗AP 1994-12-30Labeling · Supplement 9 · standardAP
1994-05-18Labeling · Supplement 7 · standardAP
1994-05-18Labeling · Supplement 8 · standardAP
1993-09-16Manufacturing (CMC) · Supplement 6 · priorityAP
1993-09-01Manufacturing (CMC) · Supplement 5 · priorityAP
1993-04-05Manufacturing (CMC) · Supplement 4 · priorityAP
1992-12-22Manufacturing (CMC) · Supplement 2 · priorityAP
1992-12-22Labeling · Supplement 3 · standardAP
1992-08-20Labeling · Supplement 1AP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.