AFINITOR · ReferencePrescription
EVEROLIMUS 7.5MG · TABLET · ORAL
AFINITOR · ReferencePrescription
EVEROLIMUS 10MG · TABLET · ORAL
AFINITOR · ReferencePrescription
EVEROLIMUS 2.5MG · TABLET · ORAL
AFINITOR · ReferencePrescription
EVEROLIMUS 5MG · TABLET · ORAL
2026-06-01Labeling · Supplement 55 · standard — Label ↗AP 2022-02-01Labeling · Supplement 51 · standard — Letter ↗AP 2021-12-30Efficacy · Supplement 50 · standard — Label ↗AP 2021-04-16Labeling · Supplement 47 · standard — Label ↗AP 2020-02-13Labeling · Supplement 44 · standard — Label ↗AP 2020-01-22Labeling · Supplement 45 · standard — Letter ↗AP 2018-04-10Efficacy · Supplement 40 · standard — Label ↗AP 2017-09-26Efficacy · Supplement 39 · standard — Label ↗AP 2016-06-14Labeling · Supplement 38 · standard — Label ↗AP 2016-02-26Efficacy · Supplement 36 · priority — Letter ↗AP 2016-02-18Efficacy · Supplement 35 · priority — Letter ↗AP 2016-02-04Labeling · Supplement 34 · standard — Label ↗AP 2016-01-29Efficacy · Supplement 32 · standard — Letter ↗AP 2015-09-18Efficacy · Supplement 31 · standard — Letter ↗AP 2015-05-22Efficacy · Supplement 30 · standard — Label ↗AP 2015-01-23Labeling · Supplement 29 · standard — Letter ↗AP 2014-12-18Efficacy · Supplement 27 · standard — Label ↗AP 2014-10-20Manufacturing (CMC) · Supplement 28 · priorityAP
2014-09-12Manufacturing (CMC) · Supplement 26 · priorityAP
2014-07-01Labeling · Supplement 25 · standard — Letter ↗AP 2014-02-20Labeling · Supplement 21 · standard — Label ↗AP 2014-02-20Labeling · Supplement 24 · standard — Label ↗AP 2014-02-20Labeling · Supplement 23 · standard — Label ↗AP 2013-11-06Efficacy · Supplement 22 · standard — Letter ↗AP 2013-06-21Manufacturing (CMC) · Supplement 20 · priorityAP
2013-03-26Manufacturing (CMC) · Supplement 19 · priorityAP
2012-08-29Labeling · Supplement 18 · standard — Letter ↗AP 2012-07-20Efficacy · Supplement 16 · standard — Label ↗AP 2012-04-26Efficacy · Supplement 17 · priority — Label ↗AP 2012-03-30Efficacy · Supplement 14 · standard — Label ↗AP 2012-03-30Labeling · Supplement 15 · unknown — Label ↗AP 2011-05-05Labeling · Supplement 10 · unknown — Label ↗AP 2011-05-05Efficacy · Supplement 9 · priority — Letter ↗AP 2010-10-29Efficacy · Supplement 6 · priority — Letter ↗AP 2010-07-09Labeling · Supplement 4 · unknown — Letter ↗AP 2010-07-09Manufacturing (CMC) · Supplement 5AP
2010-05-13Labeling · Supplement 1 · unknown — 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.