2019-03-28Labeling · Supplement 41 · standard — Letter ↗AP 2017-12-01Labeling · Supplement 40 · standard — Label ↗AP 2016-09-15Labeling · Supplement 39 · 901 required — Letter ↗AP 2016-03-22Labeling · Supplement 37 · standard — Label ↗AP 2016-03-10Manufacturing (CMC) · Supplement 38 · standardAP
2015-07-17Labeling · Supplement 35 · standard — Letter ↗AP 2015-03-27Labeling · Supplement 36 · 901 required — Label ↗AP 2013-10-29Manufacturing (CMC) · Supplement 33 · standardAP
2013-08-28Manufacturing (CMC) · Supplement 30 · standardAP
2013-03-05Manufacturing (CMC) · Supplement 32 · standardAP
2013-02-12Labeling · Supplement 31 · standard — Label ↗AP 2012-02-17Labeling · Supplement 29 · 901 required — Letter ↗AP 2011-05-10Labeling · Supplement 26 · standard — Label ↗AP 2010-04-26Labeling · Supplement 24 · unknown — Label ↗AP 2009-09-11Labeling · Supplement 21 · standard — Label ↗AP 2009-04-14Labeling · Supplement 20 · standard — Letter ↗AP 2008-04-30Labeling · Supplement 19 · standard — Letter ↗AP 2008-03-05Labeling · Supplement 17 · standard — Label ↗AP 2008-02-20Labeling · Supplement 16 · standard — Letter ↗AP 2007-12-14Labeling · Supplement 15 · standard — Letter ↗AP 2007-12-13Labeling · Supplement 14 · standard — Letter ↗AP 2007-10-12Efficacy · Supplement 13 · unknown — Letter ↗AP 2007-02-07Labeling · Supplement 10 · standard — Label ↗AP 2006-11-14Labeling · Supplement 11 · standard — Letter ↗AP 2006-08-07Labeling · Supplement 9 · standard — Letter ↗AP 2006-05-11Labeling · Supplement 8 · standard — Letter ↗AP 2006-03-10Labeling · Supplement 7 · standard — Letter ↗AP 2005-11-10Labeling · Supplement 5 · standard — Letter ↗AP 2005-06-13Labeling · Supplement 4 · standard — Label ↗AP 2004-11-29Labeling · Supplement 2 · standard — Letter ↗AP 2003-10-20Type 2 - New Active Ingredient · Original · standard — Letter ↗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.