2026-06-09Labeling · Supplement 50 · standard — Letter ↗AP 2024-06-27Labeling · Supplement 46 · standard — Label ↗AP 2023-07-18Labeling · Supplement 43 · standard — Letter ↗AP 2021-10-26Labeling · Supplement 42 · standard — Letter ↗AP 2021-09-01Labeling · Supplement 41 · standard — Letter ↗AP 2021-07-16Labeling · Supplement 40 · standard — Label ↗AP 2020-08-05Labeling · Supplement 39 · standard — Label ↗AP 2020-08-05Labeling · Supplement 38 · standard — Label ↗AP 2018-02-01Labeling · Supplement 35 · standard — Label ↗AP 2017-07-13Labeling · Supplement 33 · standard — Letter ↗AP 2015-06-05Labeling · Supplement 34 · standard — Letter ↗AP 2014-07-28Manufacturing (CMC) · Supplement 32 · priorityAP
2014-01-24Labeling · Supplement 31 · standard — Letter ↗AP 2013-10-09Manufacturing (CMC) · Supplement 30 · priorityAP
2013-05-03Labeling · Supplement 22 · standard — Letter ↗AP 2013-05-03Labeling · Supplement 23 · standard — Letter ↗AP 2012-02-13Labeling · Supplement 27 · standard — Label ↗AP 2010-07-16Labeling · Supplement 21 · unknown — Letter ↗AP 2009-12-08Labeling · Supplement 18 · standard — Letter ↗AP 2008-06-20Labeling · Supplement 14 · standard — Label ↗AP 2008-06-20Labeling · Supplement 15 · standard — Letter ↗AP 2007-09-18Manufacturing (CMC) · Supplement 16 · priorityAP
2007-04-26Labeling · Supplement 12 · standard — Review ↗AP 2007-03-26Manufacturing (CMC) · Supplement 13 · priorityAP
2005-11-02Labeling · Supplement 10 · standard — Letter ↗AP 2005-05-12Labeling · Supplement 8 · standard — Letter ↗AP 2005-05-12Efficacy · Supplement 9 · priority — Letter ↗AP 2005-02-10Labeling · Supplement 7 · standard — Letter ↗AP 2004-06-23Efficacy · Supplement 6 · priority — Letter ↗AP 2004-01-05Labeling · Supplement 5 · standard — Letter ↗AP 2003-07-22Efficacy · Supplement 4 · standard — Letter ↗AP 2002-12-19Labeling · Supplement 2 · standard — Letter ↗AP 2002-12-19Efficacy · Supplement 3 · priority — Label ↗AP 2001-02-06Labeling · Supplement 1 · standardAP
2000-04-18Type 3 - New Dosage Form · Original · priority — Label ↗AP 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.