← FDA DRUG APPROVALS

FDA BLA · BLA103772

INFLIXIMAB

Sponsor: CENTOCOR INC

APPLICATION
BLA103772
TYPE
BLA
ORIGINAL APPROVAL
1998-08-24
LATEST ACTION
2025-02-28
ROUTE
INTRAVENOUS
DOSAGE FORM
VIAL
MARKETING STATUS
Prescription

Products

REMICADEPrescription
INFLIXIMAB 100MG · VIAL

Approval history

2025-02-28Labeling · Supplement 5412 · standardLabelAP
2021-10-05Labeling · Supplement 5401 · standardLabelAP
2020-05-14Labeling · Supplement 5389 · standardLabelAP
2020-05-14Labeling · Supplement 5391 · standardLabelAP
2020-05-14Labeling · Supplement 5394 · standardLabelAP
2018-06-19Labeling · Supplement 5385 · standardLetterAP
2017-10-25Labeling · Supplement 5377 · standardLabelAP
2015-10-02Labeling · Supplement 5373 · standardLabelAP
2015-08-27Labeling · Supplement 5374 · standardLetterAP
2015-01-02Labeling · Supplement 5370 · standardLabelAP
2013-11-06Labeling · Supplement 5359 · standardLetterAP
2013-03-28Labeling · Supplement 5345 · standardLabelAP
2012-06-28Labeling · Supplement 5328 · standardLetterAP
2011-10-26Labeling · Supplement 5295 · standardLabelAP
2011-09-23Efficacy · Supplement 5301 · priorityLabelAP
2011-09-07Labeling · Supplement 5314 · standardAP
2011-08-01Supplement · Supplement 5317LetterAP
2011-02-17Labeling · Supplement 5281 · standardLetterAP
2010-12-28Labeling · Supplement 5259 · standardLabelAP
2010-10-04Labeling · Supplement 5285 · standardAP
2010-07-29Labeling · Supplement 5278 · standardLetterAP
2010-04-26Labeling · Supplement 5260 · standardLabelAP
2009-11-18Labeling · Supplement 5258 · standardLetterAP
2009-05-05Supplement · Supplement 5234LabelAP
2008-12-22Labeling · Supplement 5232 · standardLabelAP
2008-08-06Labeling · Supplement 5208 · standardAP
2008-05-19Labeling · Supplement 5206 · standardAP
2007-06-12Labeling · Supplement 5189 · standardLabelAP
2007-04-19Efficacy · Supplement 5160 · standardLabelAP
2006-12-08Labeling · Supplement 5163 · standardLetterAP
2006-10-13Efficacy · Supplement 5145 · standardLetterAP
2006-09-26Efficacy · Supplement 5129 · standardLabelAP
2006-08-11Efficacy · Supplement 5166 · standardLetterAP
2006-08-11Efficacy · Supplement 5167 · standardLabelAP
2006-05-19Efficacy · Supplement 5138 · priorityLabelAP
2006-03-17Labeling · Supplement 5135 · standardAP
2005-09-15Efficacy · Supplement 5113 · priorityLetterAP
2005-05-13Efficacy · Supplement 5089 · standardLabelAP
2005-04-05Labeling · Supplement 5092 · standardLetterAP
2004-12-17Efficacy · Supplement 5077 · standardLabelAP
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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