← FDA DRUG APPROVALS

FDA NDA · NDA022088

TORISEL

temsirolimus

Sponsor: PF PRISM CV

APPLICATION
NDA022088
TYPE
NDA
ORIGINAL APPROVAL
2007-05-30
LATEST ACTION
2018-03-23
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

TORISEL · ReferencePrescription
TEMSIROLIMUS 25MG/ML (25MG/ML) · SOLUTION · INTRAVENOUS

Approval history

2018-03-23Labeling · Supplement 23 · standard — Label ↗AP
2018-03-23Labeling · Supplement 21 · standard — Label ↗AP
2017-05-22Labeling · Supplement 20 · standard — Letter ↗AP
2016-07-27Labeling · Supplement 19 · standard — Label ↗AP
2015-02-26Labeling · Supplement 18 · standard — Label ↗AP
2014-10-07Labeling · Supplement 17 · standard — Label ↗AP
2014-04-07Labeling · Supplement 16 · standard — Label ↗AP
2013-12-20Manufacturing (CMC) · Supplement 15 · priorityAP
2012-05-30Efficacy · Supplement 14 · standard — Label ↗AP
2011-06-16Labeling · Supplement 10 · unknown — Label ↗AP
2011-06-16Labeling · Supplement 4 · standard — Label ↗AP
2011-06-16Labeling · Supplement 2 · standard — Label ↗AP
2011-06-16Labeling · Supplement 7 · standard — Label ↗AP
2011-06-16Labeling · Supplement 5 · standard — Label ↗AP
2011-06-16Labeling · Supplement 12 · unknown — Label ↗AP
2010-07-09Efficacy · Supplement 8 · standard — Letter ↗AP
2010-04-26Efficacy · Supplement 6 · standard — Letter ↗AP
2007-11-09Manufacturing (CMC) · Supplement 1 · priority — Letter ↗AP
2007-05-30Type 1 - New Molecular Entity · Original · priority — Review ↗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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