2023-10-16Labeling · Supplement 47 · standard — Letter ↗AP 2023-04-28Efficacy · Supplement 40 · standard — Letter ↗AP 2022-09-30Labeling · Supplement 45 · standard — Letter ↗AP 2022-05-19Labeling · Supplement 44 · standard — Letter ↗AP 2021-10-14Efficacy · Supplement 39 · standard — Label ↗AP 2021-09-15Labeling · Supplement 41 · standard — Letter ↗AP 2020-11-16Efficacy · Supplement 38 · standard — Label ↗AP 2020-11-16Efficacy · Supplement 36 · standard — Label ↗AP 2019-06-11Labeling · Supplement 35 · standard — Label ↗AP 2019-01-09Efficacy · Supplement 32 · standard — Label ↗AP 2018-11-11Labeling · Supplement 33 · standard — Label ↗AP 2017-11-03Efficacy · Supplement 30 · standard — Label ↗AP 2017-03-24Labeling · Supplement 29 · standard — Label ↗AP 2016-11-02Manufacturing (CMC) · Supplement 27 · standardAP
2016-07-18Manufacturing (CMC) · Supplement 16 · standardAP
2016-06-10Manufacturing (CMC) · Supplement 26 · standardAP
2015-07-09Labeling · Supplement 22 · standard — Label ↗AP 2014-08-29Efficacy · Supplement 20 · standard — Label ↗AP 2014-08-29Efficacy · Supplement 19 · standard — Label ↗AP 2014-08-12Labeling · Supplement 21 · standard — Letter ↗AP 2014-01-16Labeling · Supplement 15 · unknown — Label ↗AP 2013-10-02Manufacturing (CMC) · Supplement 17 · standardAP
2013-09-25Labeling · Supplement 8 · standard — Label ↗AP 2013-09-25Labeling · Supplement 9 · unknown — Label ↗AP 2013-04-17Labeling · Supplement 18 · standard — Letter ↗AP 2013-02-08Labeling · Supplement 5 · unknown — Letter ↗AP 2013-02-05Labeling · Supplement 14 · standard — Label ↗AP 2011-08-10REMS · Supplement 13 — Letter ↗AP 2010-04-20Labeling · Supplement 3 · unknown — Label ↗AP 2009-11-18Labeling · Supplement 1 · standard — Label ↗AP 2008-10-28Type 3 - New Dosage Form · 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.