2026-03-31Labeling · Supplement 60 · standard — Letter ↗AP 2025-05-01Labeling · Supplement 57 · standard — Letter ↗AP 2025-01-23Labeling · Supplement 56 · standard — Label ↗AP 2024-03-18Labeling · Supplement 55 · standard — Letter ↗AP 2023-02-24Labeling · Supplement 53 · standard — Letter ↗AP 2021-11-30Labeling · Supplement 52 · standard — Letter ↗AP 2021-02-10Labeling · Supplement 51 · standard — Letter ↗AP 2020-05-19Labeling · Supplement 50 · standard — Letter ↗AP 2019-11-22Labeling · Supplement 49 · standard — Letter ↗AP 2019-02-21Labeling · Supplement 48 · standard — Letter ↗AP 2018-03-06Labeling · Supplement 47 · standard — Letter ↗AP 2017-10-05Labeling · Supplement 46 · standard — Letter ↗AP 2017-03-06Labeling · Supplement 45 · standard — Label ↗AP 2016-11-02Labeling · Supplement 44 · standard — Letter ↗AP 2016-02-18Labeling · Supplement 43 · standard — Letter ↗AP 2015-09-23Labeling · Supplement 42 · standard — Letter ↗AP 2015-03-13Labeling · Supplement 41 · standard — Letter ↗AP 2015-01-07Labeling · Supplement 38 · standard — Letter ↗AP 2014-11-20Labeling · Supplement 37 · standard — Letter ↗AP 2014-08-20Labeling · Supplement 40 · standard — Letter ↗AP 2014-06-20Labeling · Supplement 33 · unknown — Label ↗AP 2014-06-19Labeling · Supplement 28 · standard — Label ↗AP 2014-06-09Labeling · Supplement 39 · standard — Label ↗AP 2013-07-31Labeling · Supplement 35 · standard — Letter ↗AP 2013-06-14Labeling · Supplement 36 · standard — Label ↗AP 2013-02-27Labeling · Supplement 34 · standard — Label ↗AP 2011-10-07Labeling · Supplement 27 · standard — Label ↗AP 2011-10-07Labeling · Supplement 25 · standard — Letter ↗AP 2011-10-07Labeling · Supplement 31 · unknown — Letter ↗AP 2011-10-07Labeling · Supplement 29 · unknown — Label ↗AP 2009-04-23Labeling · Supplement 26 · 901 required — Label ↗AP 2008-03-24Efficacy · Supplement 24 · priorityAP
2006-12-19Labeling · Supplement 21 · standard — Letter ↗AP 2006-10-13Labeling · Supplement 22 · standard — Letter ↗AP 2006-01-11Labeling · Supplement 19 · standard — Label ↗AP 2002-12-12Labeling · Supplement 15 · standard — Letter ↗AP 2002-11-05Manufacturing (CMC) · Supplement 16 · standardAP
2000-06-19Labeling · Supplement 14 · standardAP
1998-05-08Manufacturing (CMC) · Supplement 13 · standardAP
1996-12-02Manufacturing (CMC) · Supplement 11 · 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.