2020-10-21Labeling · Supplement 48 · standard — Letter ↗AP 2019-12-19Labeling · Supplement 47 · standard — Letter ↗AP 2019-08-21Labeling · Supplement 46 · standard — Letter ↗AP 2018-11-15Labeling · Supplement 45 · standard — Label ↗AP 2017-06-29Labeling · Supplement 44 · standard — Label ↗AP 2016-12-22Labeling · Supplement 42 · standard — Label ↗AP 2016-11-22Labeling · Supplement 41 · standard — Letter ↗AP 2016-09-15Labeling · Supplement 43 · 901 required — Label ↗AP 2015-11-10Labeling · Supplement 40 · standard — Letter ↗AP 2015-03-27Labeling · Supplement 39 · 901 required — Label ↗AP 2015-03-16Labeling · Supplement 38 · standard — Letter ↗AP 2013-11-07Labeling · Supplement 36 · standard — Label ↗AP 2012-11-19Labeling · Supplement 35 · standard — Letter ↗AP 2012-03-29Labeling · Supplement 33 · standard — Letter ↗AP 2012-02-17Labeling · Supplement 34 · 901 required — Letter ↗AP 2011-12-06Labeling · Supplement 32 · standard — Label ↗AP 2010-04-27Labeling · Supplement 28 · 901 required — Letter ↗AP 2009-11-23Labeling · Supplement 26 · standard — Letter ↗AP 2008-10-01Labeling · Supplement 23 · standard — Letter ↗AP 2008-08-29Labeling · Supplement 22 · standard — Label ↗AP 2008-05-16Labeling · Supplement 19 · standard — Letter ↗AP 2007-07-31Labeling · Supplement 20 · standard — Letter ↗AP 2007-05-10Labeling · Supplement 18 · standard — Label ↗AP 2005-11-09Labeling · Supplement 16 · standard — Review ↗AP 2005-10-06Efficacy · Supplement 17 · priority — Review ↗AP 2005-03-28Labeling · Supplement 14 · standard — Label ↗AP 2003-09-10Labeling · Supplement 13 · standard — Letter ↗AP 2002-12-24Manufacturing (CMC) · Supplement 12 · standardAP
2002-09-30Manufacturing (CMC) · Supplement 11 · standardAP
2002-09-30Manufacturing (CMC) · Supplement 10 · standardAP
2002-09-17Manufacturing (CMC) · Supplement 9 · standardAP
2002-03-14Labeling · Supplement 8 · standard — Letter ↗AP 2001-08-21Labeling · Supplement 5 · standard — Label ↗AP 2001-03-06Labeling · Supplement 7 · standard — Letter ↗AP 2001-02-05Manufacturing (CMC) · Supplement 6 · standardAP
2000-05-08Labeling · Supplement 4 · standardAP
1999-12-23Manufacturing (CMC) · Supplement 3 · standardAP
1999-10-26Labeling · Supplement 2 · standardAP
1999-10-21Labeling · Supplement 1 · standardAP
1999-06-29Type 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.