2023-12-11Efficacy · Supplement 5276 · standard — Label ↗AP 2021-03-24Labeling · Supplement 5275 · standard — Letter ↗AP 2020-10-15Labeling · Supplement 5273 · standard — Letter ↗AP 2017-10-13Efficacy · Supplement 5270 · standard — Label ↗AP 2015-03-18Labeling · Supplement 5264 · standard — Label ↗AP 2014-09-05Labeling · Supplement 5261 · standard — Label ↗AP 2013-07-02Labeling · Supplement 5245 · standard — Label ↗AP 2013-05-16Labeling · Supplement 5241 · standard — Label ↗AP 2011-09-29Efficacy · Supplement 5204 · standard — Label ↗AP 2011-08-22Efficacy · Supplement 5213 · priority — Label ↗AP 2011-08-09Efficacy · Supplement 5186 · standard — Label ↗AP 2011-05-27Efficacy · Supplement 5184 · standard — Label ↗AP 2011-05-09Labeling · Supplement 5216 · standardAP
2011-02-23Labeling · Supplement 5183 · standard — Label ↗AP 2010-05-24Labeling · Supplement 5176 · standard — Letter ↗AP 2010-03-03Labeling · Supplement 5177 · standard — Letter ↗AP 2009-08-07Labeling · Supplement 5171 · standardAP
2009-04-20Labeling · Supplement 5163 · standard — Label ↗AP 2009-04-20Labeling · Supplement 5147 · standard — Label ↗AP 2008-10-31Labeling · Supplement 5133 · standard — Letter ↗AP 2008-09-18Labeling · Supplement 5154 · standard — Label ↗AP 2008-06-13Labeling · Supplement 5144 · standardAP
2008-06-13Labeling · Supplement 5139 · standardAP
2007-06-19Labeling · Supplement 5120 · standard — Letter ↗AP 2005-11-18Labeling · Supplement 5076 · standardAP
2005-05-13Efficacy · Supplement 5037 · standard — Label ↗AP 2005-05-13Labeling · Supplement 5065 · standard — Letter ↗AP 2005-05-13Labeling · Supplement 5057 · standard — Letter ↗AP 2005-02-25Efficacy · Supplement 5039 · priority — Label ↗AP 2004-12-21Labeling · Supplement 5036 · standard — Label ↗AP 2003-10-31Labeling · Supplement 5016 · standardAP
2002-12-03Efficacy · Supplement 5000 · priority — Letter ↗AP 2002-10-16Type 1 - New Molecular Entity · Original · standard — 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.