2026-07-29Labeling · Supplement 65 · standardAP
2026-07-29REMS · Supplement 63AP
2025-06-27Labeling · Supplement 61 · standard — Letter ↗AP 2024-08-13REMS · Supplement 59 — Letter ↗AP 2022-08-10Labeling · Supplement 55 · standard — Letter ↗AP 2022-06-06Efficacy · Supplement 56 · standard — Letter ↗AP 2022-06-06Efficacy · Supplement 54 · standard — Letter ↗AP 2021-10-22Labeling · Supplement 50 · standard — Letter ↗AP 2021-10-22Labeling · Supplement 51 · standard — Letter ↗AP 2021-08-11REMS · Supplement 53 — Letter ↗AP 2021-04-21REMS · Supplement 52 — Letter ↗AP 2021-01-15REMS · Supplement 49 — Letter ↗AP 2019-12-13Labeling · Supplement 45 · standard — Label ↗AP 2019-02-27Labeling · Supplement 43 · standard — Letter ↗AP 2018-08-23Labeling · Supplement 41 · standard — Label ↗AP 2017-12-18Labeling · Supplement 42 · standard — Label ↗AP 2015-11-13REMS · Supplement 40 — Letter ↗AP 2015-07-16Manufacturing (CMC) · Supplement 39 · standardAP
2015-07-09Labeling · Supplement 38 · standard — Label ↗AP 2013-09-27Labeling · Supplement 36 · standard — Letter ↗AP 2013-09-27REMS · Supplement 37 — Letter ↗AP 2013-07-24Manufacturing (CMC) · Supplement 34 · standardAP
2013-02-14Manufacturing (CMC) · Supplement 32 · standardAP
2012-09-25REMS · Supplement 25 — Letter ↗AP 2012-06-22Labeling · Supplement 33 · standard — Label ↗AP 2012-06-08Labeling · Supplement 31 · standard — Letter ↗AP 2009-10-08Labeling · Supplement 28 · unknown — Label ↗AP 2009-06-18Labeling · Supplement 24 · standard — Label ↗AP 2009-02-27Labeling · Supplement 23 · standard — Letter ↗AP 2008-12-15Labeling · Supplement 22 · standard — Label ↗AP 2008-05-09Labeling · Supplement 21 · standard — Label ↗AP 2007-12-20Labeling · Supplement 18 · standard — Label ↗AP 2007-09-21Labeling · Supplement 19 · standard — Label ↗AP 2005-10-17Labeling · Supplement 15 · standard — Label ↗AP 2003-02-28Labeling · Supplement 8 · standard — Letter ↗AP 2002-12-17Manufacturing (CMC) · Supplement 11 · standardAP
2001-11-21Manufacturing (CMC) · Supplement 10 · standardAP
2001-10-03Manufacturing (CMC) · Supplement 9 · standardAP
2001-02-01Manufacturing (CMC) · Supplement 7 · standardAP
2000-12-20Efficacy · Supplement 5 · 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.