2023-09-12Labeling · Supplement 75 · standard — Letter ↗AP 2022-09-16Labeling · Supplement 78 · standard — Letter ↗AP 2021-03-01Labeling · Supplement 74 · standard — Label ↗AP 2019-05-17Labeling · Supplement 72 · standard — Letter ↗AP 2018-10-11Labeling · Supplement 69 · standard — Label ↗AP 2018-05-25Labeling · Supplement 70 · standard — Letter ↗AP 2017-10-31Labeling · Supplement 68 · standard — Label ↗AP 2017-07-10Labeling · Supplement 67 · standard — Label ↗AP 2016-09-16Labeling · Supplement 64 · standard — Label ↗AP 2016-09-16Labeling · Supplement 62 · standard — Label ↗AP 2016-03-24Manufacturing (CMC) · Supplement 63 · priorityAP
2015-07-16Labeling · Supplement 61 · standard — Letter ↗AP 2014-05-14Manufacturing (CMC) · Supplement 60 · priorityAP
2014-03-12Manufacturing (CMC) · Supplement 59 · priorityAP
2013-12-12Labeling · Supplement 58 · standard — Label ↗AP 2013-09-12Labeling · Supplement 57 · standard — Label ↗AP 2013-05-24Manufacturing (CMC) · Supplement 56 · priorityAP
2011-12-20Labeling · Supplement 55 · unknown — Label ↗AP 2011-05-06Efficacy · Supplement 51 · priority — Letter ↗AP 2011-05-03REMS · Supplement 53 — Letter ↗AP 2011-02-01REMS · Supplement 52 — Letter ↗AP 2010-08-24Labeling · Supplement 48 · standard — Letter ↗AP 2010-03-12Labeling · Supplement 42 · standard — Review ↗AP 2009-11-12Labeling · Supplement 44 · unknown — Letter ↗AP 2009-05-05Labeling · Supplement 40 · 901 required — Letter ↗AP 2007-10-22Manufacturing (CMC) · Supplement 39AP
2007-09-20Manufacturing (CMC) · Supplement 38 — Review ↗AP 2007-05-01Labeling · Supplement 37 · standard — Letter ↗AP 2006-08-17Efficacy · Supplement 34 · priority — Review ↗AP 2006-08-04Labeling · Supplement 35 · standard — Label ↗AP 2005-10-14Labeling · Supplement 33 · standard — Letter ↗AP 2005-04-26Labeling · Supplement 28 · standard — Letter ↗AP 2005-04-25Labeling · Supplement 30 · standard — Label ↗AP 2005-04-25Labeling · Supplement 31 · standard — Label ↗AP 2004-10-13Labeling · Supplement 23 · standard — Letter ↗AP 2003-09-29Labeling · Supplement 21 · standard — Letter ↗AP 2003-09-29Labeling · Supplement 24 · standard — Letter ↗AP 2002-09-10Manufacturing (CMC) · Supplement 20 · priority — Review ↗AP 2002-06-10Manufacturing (CMC) · Supplement 22 · priorityAP
2002-02-27Efficacy · Supplement 19 · priority — Review ↗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.