2025-01-22Labeling · Supplement 74 · standard — Label ↗AP 2022-03-11Labeling · Supplement 73 · standard — Letter ↗AP 2021-02-12Labeling · Supplement 71 · standard — Letter ↗AP 2020-02-05Labeling · Supplement 72 · 901 required — Letter ↗AP 2019-01-25Labeling · Supplement 70 · standard — Label ↗AP 2018-07-27Labeling · Supplement 68 · standard — Letter ↗AP 2017-02-23Labeling · Supplement 66 · 901 required — Label ↗AP 2016-03-01Labeling · Supplement 65 · standard — Letter ↗AP 2014-04-28Labeling · Supplement 62 · standard — Label ↗AP 2012-08-02Efficacy · Supplement 53 · standard — Letter ↗AP 2012-03-12Labeling · Supplement 55 · standard — Letter ↗AP 2011-09-24Labeling · Supplement 48 · standard — Letter ↗AP 2011-09-24Labeling · Supplement 54 · standard — Label ↗AP 2011-08-24Labeling · Supplement 47 · standard — Label ↗AP 2011-06-15Labeling · Supplement 52 · standard — Letter ↗AP 2010-12-01Labeling · Supplement 51 · 901 required — Label ↗AP 2010-08-30Labeling · Supplement 49 · unknown — Letter ↗AP 2010-08-30Labeling · Supplement 43 · standard — Letter ↗AP 2010-08-30Labeling · Supplement 46 · unknown — Letter ↗AP 2010-08-30Labeling · Supplement 50 · unknown — Label ↗AP 2009-07-19Labeling · Supplement 44 · 901 required — Label ↗AP 2008-08-14Labeling · Supplement 42 · standard — Letter ↗AP 2007-08-22Efficacy · Supplement 37 · priority — Label ↗AP 2007-08-22Efficacy · Supplement 36 · priority — Review ↗AP 2006-10-06Efficacy · Supplement 24 · priority — Review ↗AP 2006-10-06Efficacy · Supplement 29 · standard — Letter ↗AP 2006-10-06Efficacy · Supplement 28 · standard — Review ↗AP 2005-08-17Labeling · Supplement 30 · standard — Label ↗AP 2003-12-04Efficacy · Supplement 17 · standard — Letter ↗AP 2003-12-04Efficacy · Supplement 18 · standard — Label ↗AP 2003-11-21Labeling · Supplement 23 · standard — Letter ↗AP 2003-10-29Labeling · Supplement 16 · standard — Letter ↗AP 2003-09-10Labeling · Supplement 21 · standard — Review ↗AP 2002-11-19Labeling · Supplement 15 · standard — Letter ↗AP 2002-03-03Efficacy · Supplement 4 · standard — Review ↗AP 2001-10-22Manufacturing (CMC) · Supplement 13 · standardAP
1999-07-02Labeling · Supplement 5 · standard — Label ↗AP 1998-10-08Manufacturing (CMC) · Supplement 9 · standardAP
1998-06-03Manufacturing (CMC) · Supplement 8 · standardAP
1998-05-19Manufacturing (CMC) · Supplement 6 · 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.