← FDA DRUG APPROVALS

FDA NDA · NDA021083

SIROLIMUS

Sponsor: PF PRISM CV

APPLICATION
NDA021083
TYPE
NDA
ORIGINAL APPROVAL
1999-09-15
LATEST ACTION
2022-08-22
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

RAPAMUNE · ReferencePrescription
SIROLIMUS 1MG/ML · SOLUTION · ORAL

Approval history

2022-08-22Labeling · Supplement 70 · standard — Letter ↗AP
2022-08-22Labeling · Supplement 69 · standard — Letter ↗AP
2020-01-02Labeling · Supplement 67 · standard — Letter ↗AP
2019-07-15Labeling · Supplement 64 · standard — Letter ↗AP
2019-06-18Labeling · Supplement 66 · standard — Letter ↗AP
2019-04-05Labeling · Supplement 65 · standard — Label ↗AP
2018-05-23Labeling · Supplement 61 · standard — Letter ↗AP
2018-01-12Labeling · Supplement 62 · standard — Label ↗AP
2017-04-11Labeling · Supplement 59 · standard — Label ↗AP
2015-11-05Labeling · Supplement 58 · standard — Letter ↗AP
2015-07-31Manufacturing (CMC) · Supplement 57 · priorityAP
2015-05-28Efficacy · Supplement 55 · priority — Letter ↗AP
2015-03-06Labeling · Supplement 56 · standard — Letter ↗AP
2013-05-30Labeling · Supplement 54 · standard — Letter ↗AP
2013-03-07Labeling · Supplement 53 · standard — Letter ↗AP
2012-12-10Labeling · Supplement 51 · standard — Label ↗AP
2011-07-11Labeling · Supplement 49 · unknown — Letter ↗AP
2011-06-06REMS · Supplement 50 — Letter ↗AP
2010-11-23Labeling · Supplement 44 · unknown — Letter ↗AP
2010-11-23Labeling · Supplement 47 · 901 required — Letter ↗AP
2010-11-08Labeling · Supplement 48 · standard — Label ↗AP
2010-07-02Labeling · Supplement 46 · unknown — Letter ↗AP
2010-04-22Labeling · Supplement 43 · unknown — Label ↗AP
2010-04-22Labeling · Supplement 42 · unknown — Label ↗AP
2010-01-25Labeling · Supplement 45 · unknown — Label ↗AP
2009-10-08Labeling · Supplement 41 · 901 required — Label ↗AP
2009-09-24Labeling · Supplement 40 · standard — Label ↗AP
2009-01-29Labeling · Supplement 38 · standard — Label ↗AP
2008-03-05Labeling · Supplement 36 · standard — Label ↗AP
2008-03-05Labeling · Supplement 37 · standard — Label ↗AP
2008-01-14Efficacy · Supplement 33 · standard — Label ↗AP
2007-10-17Labeling · Supplement 34 · standard — Letter ↗AP
2007-05-02Labeling · Supplement 31 · standard — Letter ↗AP
2007-01-30Efficacy · Supplement 29 · unknown — Letter ↗AP
2007-01-12Labeling · Supplement 30 · standard — Letter ↗AP
2007-01-09Labeling · Supplement 26 · standard — Letter ↗AP
2006-10-19Labeling · Supplement 28 · standard — Label ↗AP
2006-06-02Labeling · Supplement 25 · standard — Letter ↗AP
2006-06-02Efficacy · Supplement 24 · unknown — Letter ↗AP
2005-10-07Labeling · Supplement 23 · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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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.

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