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FDA BLA · BLA125084

ERBITUX

cetuximab

Sponsor: IMCLONE

APPLICATION
BLA125084
TYPE
BLA
ORIGINAL APPROVAL
2004-02-12
LATEST ACTION
2021-09-24
ROUTE
INTRAVENOUS
DOSAGE FORM
VIAL
MARKETING STATUS
Prescription

Products

ERBITUXPrescription
CETUXIMAB 100mg/VIAL · VIAL · INTRAVENOUS

Approval history

2021-09-24Efficacy · Supplement 279 · standard — Letter ↗AP
2021-04-06Efficacy · Supplement 280 · standard — Label ↗AP
2021-04-06Efficacy · Supplement 277 · standard — Label ↗AP
2020-11-10Labeling · Supplement 275 · standard — Letter ↗AP
2019-04-23Labeling · Supplement 273 · standard — Label ↗AP
2018-06-05Labeling · Supplement 269 · standard — Letter ↗AP
2018-05-04Labeling · Supplement 268 · standard — Label ↗AP
2016-10-11Labeling · Supplement 265 · standard — Letter ↗AP
2015-04-10Labeling · Supplement 262 · standard — Letter ↗AP
2015-03-11Labeling · Supplement 263 · standard — Label ↗AP
2013-03-04Labeling · Supplement 242 · standard — Label ↗AP
2012-07-06Efficacy · Supplement 225 · standard — Label ↗AP
2012-01-24Labeling · Supplement 228 · standard — Letter ↗AP
2012-01-19Labeling · Supplement 229 · standard — Letter ↗AP
2011-11-07Efficacy · Supplement 153 · priority — Label ↗AP
2011-03-24Labeling · Supplement 203 · standardAP
2010-07-08Labeling · Supplement 193 · standardAP
2009-07-17Supplement · Supplement 168 — Label ↗AP
2009-07-17Labeling · Supplement 167 · standard — Label ↗AP
2008-09-12Labeling · Supplement 139 · standard — Letter ↗AP
2007-11-20Labeling · Supplement 112 · standardAP
2007-10-02Efficacy · Supplement 103 · priority — Review ↗AP
2006-03-01Efficacy · Supplement 76 · priority — Label ↗AP
2006-03-01Efficacy · Supplement 46 · priority — Letter ↗AP
2005-09-01Labeling · Supplement 30 · standard — Label ↗AP
2004-06-18Supplement · Supplement 1 — Letter ↗AP
2004-02-12Type 1 - New Molecular Entity · Original · priority — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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