2026-02-19Labeling · Supplement 70 · standard — Letter ↗AP 2026-01-28Labeling · Supplement 69 · standard — Label ↗AP 2025-03-12Labeling · Supplement 67 · standard — Letter ↗AP 2022-10-18Labeling · Supplement 63 · standard — Letter ↗AP 2022-08-16Labeling · Supplement 64 · standard — Letter ↗AP 2022-01-28Labeling · Supplement 62 · standard — Letter ↗AP 2021-10-13Labeling · Supplement 61 · standard — Letter ↗AP 2021-04-15Labeling · Supplement 60 · standard — Label ↗AP 2021-01-25Labeling · Supplement 59 · standard — Label ↗AP 2021-01-14Labeling · Supplement 57 · standard — Letter ↗AP 2020-09-04Labeling · Supplement 58 · standard — Label ↗AP 2019-04-30Labeling · Supplement 55 · standard — Label ↗AP 2019-01-29Efficacy · Supplement 50 · priority — Label ↗AP 2017-07-28Labeling · Supplement 54 · standard — Label ↗AP 2017-06-15Labeling · Supplement 53 · standard — Letter ↗AP 2016-01-15Manufacturing (CMC) · Supplement 48 · standardAP
2015-02-03Labeling · Supplement 47 · standard — Letter ↗AP 2014-06-24Manufacturing (CMC) · Supplement 46 · standardAP
2014-06-09Manufacturing (CMC) · Supplement 45 · standardAP
2014-04-07Labeling · Supplement 44 · standard — Letter ↗AP 2013-07-25Manufacturing (CMC) · Supplement 42 · standardAP
2011-11-16Labeling · Supplement 40 · standard — Label ↗AP 2011-06-01Labeling · Supplement 37 · unknown — Label ↗AP 2010-12-15Labeling · Supplement 34 · unknown — Letter ↗AP 2010-11-21Labeling · Supplement 36 · unknown — Letter ↗AP 2010-06-17Labeling · Supplement 32 · unknown — Letter ↗AP 2010-06-17Labeling · Supplement 29 · standard — Letter ↗AP 2010-06-17Labeling · Supplement 33 · unknown — Letter ↗AP 2010-06-17Labeling · Supplement 25 · standard — Letter ↗AP 2008-05-30Labeling · Supplement 26 · standard — Letter ↗AP 2008-03-10Labeling · Supplement 24 · standard — Label ↗AP 2008-02-05Labeling · Supplement 16 · standard — Label ↗AP 2006-12-01Labeling · Supplement 21 · standard — Letter ↗AP 2006-05-19Labeling · Supplement 19 · standard — Label ↗AP 2006-03-10Labeling · Supplement 15 · standard — Label ↗AP 2005-12-18Labeling · Supplement 12 · standard — Letter ↗AP 2005-07-07Labeling · Supplement 11 · standard — Label ↗AP 2005-03-24Labeling · Supplement 10 · standard — Label ↗AP 2004-12-21Efficacy · Supplement 9 · standard — Label ↗AP 2004-04-21Labeling · Supplement 5 · standard — Letter ↗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.