2022-12-15Labeling · Supplement 73 · standard — Letter ↗AP 2020-10-21Labeling · Supplement 72 · standard — Letter ↗AP 2019-12-19Labeling · Supplement 71 · standard — Letter ↗AP 2019-08-21Labeling · Supplement 70 · standard — Letter ↗AP 2018-11-15Labeling · Supplement 69 · standard — Label ↗AP 2017-09-29Labeling · Supplement 68 · standard — Label ↗AP 2017-06-29Labeling · Supplement 66 · standard — Label ↗AP 2017-06-07Labeling · Supplement 67 · standard — Label ↗AP 2016-12-22Labeling · Supplement 64 · standard — Label ↗AP 2016-11-22Labeling · Supplement 63 · standard — Letter ↗AP 2016-09-15Labeling · Supplement 65 · 901 required — Letter ↗AP 2015-11-10Labeling · Supplement 62 · standard — Letter ↗AP 2015-03-27Labeling · Supplement 61 · 901 required — Letter ↗AP 2015-03-16Labeling · Supplement 60 · standard — Label ↗AP 2013-11-07Labeling · Supplement 58 · standard — Label ↗AP 2012-11-20Labeling · Supplement 57 · standard — Letter ↗AP 2012-02-17Labeling · Supplement 56 · 901 required — Label ↗AP 2011-12-06Labeling · Supplement 55 · standard — Label ↗AP 2010-04-27Labeling · Supplement 50 · 901 required — Label ↗AP 2010-02-10Labeling · Supplement 45 · standard — Label ↗AP 2009-11-23Labeling · Supplement 47 · standard — Letter ↗AP 2008-10-01Labeling · Supplement 43 · standard — Letter ↗AP 2008-08-29Labeling · Supplement 42 · standard — Label ↗AP 2008-05-16Labeling · Supplement 39 · standard — Letter ↗AP 2007-07-31Labeling · Supplement 40 · standard — Label ↗AP 2007-05-10Labeling · Supplement 36 · standard — Label ↗AP 2005-11-09Labeling · Supplement 33 · standard — Review ↗AP 2005-10-06Efficacy · Supplement 34 · priority — Review ↗AP 2005-03-28Labeling · Supplement 32 · standard — Letter ↗AP 2003-09-10Labeling · Supplement 30 · standard — Label ↗AP 2002-12-24Manufacturing (CMC) · Supplement 28 · priorityAP
2002-03-14Labeling · Supplement 27 · standard — Label ↗AP 2001-08-21Labeling · Supplement 25 · standard — Label ↗AP 2001-03-06Labeling · Supplement 26 · standard — Letter ↗AP 2000-09-01Manufacturing (CMC) · Supplement 24 · priorityAP
2000-05-08Labeling · Supplement 23 · standardAP
1999-10-28Manufacturing (CMC) · Supplement 20 · priorityAP
1999-10-26Labeling · Supplement 22 · standardAP
1999-10-21Labeling · Supplement 21 · standardAP
1999-05-26Efficacy · Supplement 13 · standard — 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.