2026-07-29Labeling · Supplement 56 · standardAP
2026-07-29REMS · Supplement 54AP
2025-06-27Labeling · Supplement 52 · standard — Letter ↗AP 2024-08-13REMS · Supplement 51 — Letter ↗AP 2022-08-10Labeling · Supplement 48 · standard — Letter ↗AP 2022-06-06Efficacy · Supplement 49 · standard — Letter ↗AP 2022-06-06Efficacy · Supplement 47 · standard — Letter ↗AP 2021-10-22Labeling · Supplement 43 · standard — Letter ↗AP 2021-10-22Labeling · Supplement 42 · standard — Letter ↗AP 2021-08-11REMS · Supplement 45 — Letter ↗AP 2021-04-21REMS · Supplement 44 — Letter ↗AP 2021-01-15REMS · Supplement 41 — Letter ↗AP 2019-12-13Labeling · Supplement 37 · standard — Label ↗AP 2019-02-27Labeling · Supplement 35 · standard — Label ↗AP 2018-08-23Labeling · Supplement 33 · standard — Label ↗AP 2017-12-18Labeling · Supplement 34 · standard — Label ↗AP 2016-05-26Manufacturing (CMC) · Supplement 32 · standardAP
2015-11-13REMS · Supplement 31 — Letter ↗AP 2015-07-09Labeling · Supplement 30 · standard — Label ↗AP 2013-09-27REMS · Supplement 29 — Letter ↗AP 2013-09-27Labeling · Supplement 28 · standard — Label ↗AP 2013-02-14Manufacturing (CMC) · Supplement 25 · standardAP
2012-09-25REMS · Supplement 20 — Letter ↗AP 2012-06-22Labeling · Supplement 26 · standard — Label ↗AP 2012-06-08Labeling · Supplement 24 · standard — Label ↗AP 2009-10-08Labeling · Supplement 22 · unknown — Label ↗AP 2009-06-18Labeling · Supplement 19 · standard — Label ↗AP 2009-02-27Labeling · Supplement 18 · standard — Letter ↗AP 2008-12-15Labeling · Supplement 17 · standard — Label ↗AP 2008-05-09Labeling · Supplement 16 · standard — Label ↗AP 2007-12-20Labeling · Supplement 13 · standard — Label ↗AP 2007-09-21Labeling · Supplement 14 · standard — Letter ↗AP 2005-10-17Labeling · Supplement 12 · standard — Letter ↗AP 2005-04-12Labeling · Supplement 10 · standard — Label ↗AP 2003-02-28Labeling · Supplement 5 · standard — Label ↗AP 2002-12-17Manufacturing (CMC) · Supplement 7 · standardAP
2002-02-27Manufacturing (CMC) · Supplement 6 · standardAP
2000-07-28Efficacy · Supplement 4 · standard — Label ↗AP 2000-07-27Labeling · Supplement 3 · standard — Review ↗AP 2000-06-16Manufacturing (CMC) · Supplement 2 · standardAP
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.