SUSTIVA · ReferenceDiscontinued
EFAVIRENZ 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
SUSTIVA · ReferenceDiscontinued
EFAVIRENZ 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
2023-11-08Labeling · Supplement 47 · standard — Label ↗AP 2019-10-29Labeling · Supplement 45 · standard — Letter ↗AP 2017-10-10Labeling · Supplement 44 · standard — Label ↗AP 2017-01-30Labeling · Supplement 42 · standard — Letter ↗AP 2016-10-31Manufacturing (CMC) · Supplement 40 · standardAP
2016-10-12Labeling · Supplement 41 · standard — Label ↗AP 2016-08-31Labeling · Supplement 39 · standard — Letter ↗AP 2016-03-31Labeling · Supplement 38 · standard — Letter ↗AP 2015-03-27Labeling · Supplement 37 · standard — Letter ↗AP 2014-08-14Manufacturing (CMC) · Supplement 36 · standardAP
2014-05-23Labeling · Supplement 35 · standard — Letter ↗AP 2014-01-22Manufacturing (CMC) · Supplement 34 · standardAP
2013-07-09Manufacturing (CMC) · Supplement 32 · standardAP
2013-05-02Efficacy · Supplement 31 · priority — Letter ↗AP 2012-08-10Labeling · Supplement 30 · 901 required — Label ↗AP 2012-06-22Labeling · Supplement 29 · standard — Letter ↗AP 2011-12-19Labeling · Supplement 28 · standard — Label ↗AP 2011-09-26Labeling · Supplement 26 · standard — Label ↗AP 2010-11-30Labeling · Supplement 24 · standard — Letter ↗AP 2010-03-31Labeling · Supplement 23 · unknown — Letter ↗AP 2009-09-23Labeling · Supplement 21 · standard — Label ↗AP 2009-03-11Labeling · Supplement 18 · standard — Letter ↗AP 2008-08-18Labeling · Supplement 19 · standard — Label ↗AP 2008-08-18Labeling · Supplement 17 · standard — Letter ↗AP 2007-01-24Labeling · Supplement 16 · standard — Label ↗AP 2006-03-28Labeling · Supplement 14 · standard — Label ↗AP 2005-04-20Labeling · Supplement 13 · standard — Label ↗AP 2004-10-22Labeling · Supplement 9 · standard — Label ↗AP 2004-08-13Efficacy · Supplement 6 · unknown — Review ↗AP 2003-11-13Labeling · Supplement 5 · standard — Letter ↗AP 2003-06-10Labeling · Supplement 4 · standard — Label ↗AP 2003-06-10Labeling · Supplement 3 · standard — Label ↗AP 2002-09-20Labeling · Supplement 1 · standard — Letter ↗AP 2002-02-01Type 3 - New Dosage Form · Original · standard — Label ↗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.