2025-09-23Labeling · Supplement 41 · standard — Letter ↗AP 2024-09-04Labeling · Supplement 42 · standard — Letter ↗AP 2019-01-04Labeling · Supplement 36 · standard — Label ↗AP 2018-03-22Labeling · Supplement 35 · standard — Label ↗AP 2017-11-17Labeling · Supplement 34 · standard — Label ↗AP 2017-03-23Labeling · Supplement 31 · standard — Letter ↗AP 2014-07-03Labeling · Supplement 27 · unknown — Letter ↗AP 2014-06-06Labeling · Supplement 30 · standard — Letter ↗AP 2014-05-08Manufacturing (CMC) · Supplement 29 · standardAP
2014-02-28Manufacturing (CMC) · Supplement 28 · standardAP
2013-02-08Labeling · Supplement 23 · standard — Letter ↗AP 2011-10-30REMS · Supplement 25 — Letter ↗AP 2011-03-03Labeling · Supplement 18 · standard — Letter ↗AP 2011-03-03Labeling · Supplement 22 · standard — Label ↗AP 2011-03-03Labeling · Supplement 20 · standard — Label ↗AP 2011-03-03Labeling · Supplement 19 · standard — Letter ↗AP 2011-03-03Labeling · Supplement 9 · standard — Label ↗AP 2011-03-03Labeling · Supplement 15 · standard — Letter ↗AP 2011-03-03Labeling · Supplement 13 · standard — Letter ↗AP 2009-04-23Labeling · Supplement 21 · 901 required — Letter ↗AP 2007-08-31Labeling · Supplement 14 · standard — Letter ↗AP 2005-10-28Efficacy · Supplement 8 · priority — Label ↗AP 2005-03-25Labeling · Supplement 7 · standard — Letter ↗AP 2002-09-10Manufacturing (CMC) · Supplement 3 · standardAP
2002-04-01Labeling · Supplement 2 · standard — Letter ↗AP 2002-01-18Manufacturing (CMC) · Supplement 1 · standardAP
2001-05-25Type 3 - New Dosage Form · Original · 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.