2025-09-23Labeling · Supplement 315 · standard — Letter ↗AP 2024-09-13Efficacy · Supplement 275 · standard — Label ↗AP 2023-11-08Labeling · Supplement 309 · standard — Letter ↗AP 2022-12-22Efficacy · Supplement 305 · standard — Letter ↗AP 2019-09-06Labeling · Supplement 293 · standard — Letter ↗AP 2019-03-28Efficacy · Supplement 237 · standard — Letter ↗AP 2019-02-27Labeling · Supplement 289 · standard — Letter ↗AP 2018-06-14Manufacturing (CMC) · Supplement 279AP
2018-05-24Efficacy · Supplement 283 · standard — Label ↗AP 2018-03-20Labeling · Supplement 281 · standard — Label ↗AP 2018-03-16Manufacturing (CMC) · Supplement 286AP
2017-01-04Labeling · Supplement 270 · standard — Label ↗AP 2016-04-28Labeling · Supplement 241 · standard — Label ↗AP 2016-02-26Labeling · Supplement 266 · standardAP
2016-02-03Labeling · Supplement 268 · standard — Letter ↗AP 2015-10-19Labeling · Supplement 264 · standard — Label ↗AP 2013-10-17Efficacy · Supplement 215 · standard — Review ↗AP 2013-09-27Efficacy · Supplement 213 · standard — Review ↗AP 2012-11-15Labeling · Supplement 189 · standard — Label ↗AP 2012-10-05Labeling · Supplement 186 · standard — Label ↗AP 2012-10-05Labeling · Supplement 192 · standard — Label ↗AP 2012-08-29Labeling · Supplement 180 · standard — Label ↗AP 2012-08-02Labeling · Supplement 142 · standard — Label ↗AP 2012-04-17Efficacy · Supplement 174 · standard — Label ↗AP 2011-09-14Labeling · Supplement 152 · standardAP
2011-09-07Labeling · Supplement 157 · standard — Letter ↗AP 2011-07-26Labeling · Supplement 155 · standardAP
2010-12-21Labeling · Supplement 122 · standardAP
2010-10-06Labeling · Supplement 126 · standard — Letter ↗AP 2010-07-29Labeling · Supplement 111 · standard — Label ↗AP 2009-11-18Labeling · Supplement 92 · standard — Letter ↗AP 2009-05-13Efficacy · Supplement 80 · standard — Review ↗AP 2008-12-31Labeling · Supplement 38 · standard — Letter ↗AP 2008-12-22Labeling · Supplement 36 · standardAP
2008-04-22Type 1 - New Molecular Entity · Original · standard — Summary 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.