2020-11-24Labeling · Supplement 38 · standard — Label ↗AP 2018-05-09Labeling · Supplement 36 · standard — Letter ↗AP 2018-05-09Labeling · Supplement 37 · standard — Letter ↗AP 2017-03-20Labeling · Supplement 35 · standard — Label ↗AP 2015-09-30Labeling · Supplement 34 · standard — Letter ↗AP 2015-03-23Efficacy · Supplement 31 · standard — Label ↗AP 2015-02-19Labeling · Supplement 32 · standard — Label ↗AP 2013-09-11Labeling · Supplement 30 · standard — Label ↗AP 2012-05-18Labeling · Supplement 29 · standard — Letter ↗AP 2012-03-15Labeling · Supplement 28 · standard — Letter ↗AP 2011-11-18Labeling · Supplement 27 · 901 required — Label ↗AP 2011-05-13REMS · Supplement 26 — Letter ↗AP 2010-08-04REMS · Supplement 24 — Letter ↗AP 2008-12-19Labeling · Supplement 22 · standard — Letter ↗AP 2008-07-18Efficacy · Supplement 20 · unknown — Letter ↗AP 2007-05-07Labeling · Supplement 19 · standard — Letter ↗AP 2006-08-11Labeling · Supplement 16 · standard — Label ↗AP 2004-08-02Efficacy · Supplement 14 · unknown — Letter ↗AP 2004-07-26Labeling · Supplement 15 · standard — Label ↗AP 2004-04-15Efficacy · Supplement 13 · unknown — Letter ↗AP 2003-07-17Labeling · Supplement 12 · standard — Label ↗AP 2002-12-24Manufacturing (CMC) · Supplement 9 · priority — Review ↗AP 2002-10-02Labeling · Supplement 8 · standard — Label ↗AP 2002-08-14Labeling · Supplement 10 · standard — Letter ↗AP 2002-06-04Labeling · Supplement 7 · standardAP
2002-01-28Labeling · Supplement 6 · standard — Letter ↗AP 2001-07-13Manufacturing (CMC) · Supplement 5 · priorityAP
2000-12-15Efficacy · Supplement 2 · standard — Review ↗AP 2000-07-27Labeling · Supplement 4 · standardAP
2000-04-20Labeling · Supplement 1 · standardAP
1998-12-17Type 3 - New Dosage Form · Original · priority — 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.