2024-08-12Efficacy · Supplement 70 · standard — Label ↗AP 2023-07-18Labeling · Supplement 69 · standard — Letter ↗AP 2022-03-04Labeling · Supplement 64 · standard — Letter ↗AP 2020-11-27Labeling · Supplement 62 · standard — Label ↗AP 2019-04-25Labeling · Supplement 61 · standard — Letter ↗AP 2018-06-07Labeling · Supplement 60 · standard — Label ↗AP 2017-12-20Labeling · Supplement 55 · standard — Label ↗AP 2017-12-06Labeling · Supplement 58 · standard — Label ↗AP 2017-07-06Labeling · Supplement 59 · standard — Label ↗AP 2016-10-24Labeling · Supplement 54 · standard — Letter ↗AP 2015-11-09Manufacturing (CMC) · Supplement 53 · standardAP
2014-12-19Labeling · Supplement 52 · 901 required — Letter ↗AP 2014-11-05Manufacturing (CMC) · Supplement 51 · standardAP
2014-09-26Manufacturing (CMC) · Supplement 50 · standardAP
2014-09-26Manufacturing (CMC) · Supplement 49 · standardAP
2014-03-04Manufacturing (CMC) · Supplement 47 · standardAP
2013-12-12Labeling · Supplement 48 · standard — Letter ↗AP 2012-09-28Labeling · Supplement 44 · standard — Letter ↗AP 2012-05-10Labeling · Supplement 45 · standard — Label ↗AP 2011-12-07Labeling · Supplement 42 · unknown — Letter ↗AP 2011-06-07Labeling · Supplement 41 · unknown — Label ↗AP 2011-05-20Labeling · Supplement 43 · unknown — Letter ↗AP 2010-09-03Labeling · Supplement 40 · unknown — Letter ↗AP 2007-12-20Labeling · Supplement 38 · standard — Letter ↗AP 2005-08-03Manufacturing (CMC) · Supplement 32 · standard — Letter ↗AP 2005-08-02Labeling · Supplement 31 · standard — Label ↗AP 2004-12-06Supplement · Original · standardAP
2004-12-06Efficacy · Supplement 27 · unknown — Label ↗AP 2004-11-18Labeling · Supplement 28 · standard — Letter ↗AP 2004-10-28Manufacturing (CMC) · Supplement 29 · standard — Letter ↗AP 2004-05-05Labeling · Supplement 19 · standard — Label ↗AP 2004-04-02Manufacturing (CMC) · Supplement 24 · standard — Letter ↗AP 2004-04-02Labeling · Supplement 25 · standard — Label ↗AP 2004-03-05Labeling · Supplement 15 · standard — Letter ↗AP 2004-01-09Labeling · Supplement 20 · standard — Label ↗AP 2004-01-02Labeling · Supplement 21 · standard — Letter ↗AP 2003-11-18Labeling · Supplement 17 · standard — Label ↗AP 2003-10-24Labeling · Supplement 16 · standard — Letter ↗AP 2003-02-21Labeling · Supplement 7 · standard — Letter ↗AP 2002-12-04Manufacturing (CMC) · Supplement 14 · 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.