← FDA DRUG APPROVALS

FDA BLA · BLA125019

ZEVALIN

ibritumomab tiuxetan

Sponsor: SPECTRUM PHARMS

APPLICATION
BLA125019
TYPE
BLA
ORIGINAL APPROVAL
2002-02-19
LATEST ACTION
2018-12-11
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

ZEVALINPrescription
IBRITUMOMAB TIUXETAN 3.2MG/2ML · INJECTABLE · INJECTION

Approval history

2018-12-11Labeling · Supplement 227 · standard — Label ↗AP
2013-08-30Labeling · Supplement 210 — Label ↗AP
2013-08-30Labeling · Supplement 213 · standard — Label ↗AP
2011-11-18Efficacy · Supplement 194 · standard — Label ↗AP
2010-12-16Labeling · Supplement 185 · standardAP
2009-09-03Efficacy · Supplement 156 · priority — Label ↗AP
2008-03-25Labeling · Supplement 135 · standard — Letter ↗AP
2007-11-02Labeling · Supplement 132 · standard — Label ↗AP
2007-01-04Labeling · Supplement 117 · standardAP
2005-09-13Labeling · Supplement 92 · standard — Label ↗AP
2005-07-27Efficacy · Supplement 88 · standard — Label ↗AP
2004-10-29Labeling · Supplement 70 · standard — Label ↗AP
2004-10-22Efficacy · Supplement 58 · standard — Label ↗AP
2003-01-30Labeling · Supplement 8 · standardAP
2002-02-19Type 1 - New Molecular Entity · Original · priority — Label ↗AP
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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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