RAPAMUNE · ReferencePrescription
SIROLIMUS 0.5MG · TABLET · ORAL
RAPAMUNE · ReferencePrescription
SIROLIMUS 2MG · TABLET · ORAL
RAPAMUNE · ReferenceDiscontinued
SIROLIMUS 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
RAPAMUNE · ReferencePrescription
SIROLIMUS 1MG · TABLET · ORAL
2022-08-22Labeling · Supplement 87 · standard — Letter ↗AP 2022-08-22Labeling · Supplement 88 · standard — Letter ↗AP 2021-08-09Labeling · Supplement 86 · standard — Letter ↗AP 2020-01-02Labeling · Supplement 85 · standard — Letter ↗AP 2019-07-15Labeling · Supplement 83 · standard — Letter ↗AP 2019-04-05Labeling · Supplement 84 · standard — Label ↗AP 2018-05-23Labeling · Supplement 80 · standard — Letter ↗AP 2018-01-12Labeling · Supplement 81 · standard — Label ↗AP 2017-04-11Labeling · Supplement 76 · standard — Label ↗AP 2015-11-05Labeling · Supplement 75 · standard — Letter ↗AP 2015-05-28Efficacy · Supplement 73 · priority — Label ↗AP 2015-03-30Manufacturing (CMC) · Supplement 72 · standardAP
2015-03-06Labeling · Supplement 74 · standard — Label ↗AP 2014-07-03Manufacturing (CMC) · Supplement 71 · standardAP
2014-01-29Manufacturing (CMC) · Supplement 70 · standardAP
2013-11-06Manufacturing (CMC) · Supplement 69 · standardAP
2013-05-30Labeling · Supplement 68 · standard — Letter ↗AP 2013-03-07Labeling · Supplement 67 · standard — Letter ↗AP 2012-12-10Labeling · Supplement 65 · standard — Letter ↗AP 2011-07-11Labeling · Supplement 59 · unknown — Letter ↗AP 2011-06-06REMS · Supplement 60 — Letter ↗AP 2010-11-23Labeling · Supplement 57 · 901 required — Letter ↗AP 2010-11-23Labeling · Supplement 55 · unknown — Letter ↗AP 2010-11-08Labeling · Supplement 58 · unknown — Letter ↗AP 2010-07-02Labeling · Supplement 56 · unknown — Letter ↗AP 2010-04-22Labeling · Supplement 53 · unknown — Label ↗AP 2010-04-22Labeling · Supplement 54 · unknown — Letter ↗AP 2010-01-25Manufacturing (CMC) · Supplement 52 · standard — Label ↗AP 2009-10-08Labeling · Supplement 51 · 901 required — Letter ↗AP 2009-09-24Labeling · Supplement 50 · standard — Label ↗AP 2009-01-29Labeling · Supplement 49 · standard — Label ↗AP 2008-03-05Labeling · Supplement 47 · standard — Letter ↗AP 2008-03-05Labeling · Supplement 48 · standard — Letter ↗AP 2008-01-14Efficacy · Supplement 43 · standard — Letter ↗AP 2007-10-17Labeling · Supplement 45 · standard — Letter ↗AP 2007-05-02Labeling · Supplement 39 · standard — Letter ↗AP 2007-01-30Efficacy · Supplement 37 · unknown — Letter ↗AP 2007-01-12Labeling · Supplement 38 · standard — Label ↗AP 2007-01-09Labeling · Supplement 35 · standard — Letter ↗AP 2006-10-19Labeling · Supplement 36 · 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.