← FDA DRUG APPROVALS

FDA BLA · BLA125289

SIMPONI

golimumab

Sponsor: CENTOCOR ORTHO BIOTECH INC

APPLICATION
BLA125289
TYPE
BLA
ORIGINAL APPROVAL
2009-04-24
LATEST ACTION
2025-10-22
ROUTE
SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

SIMPONIPrescription
GOLIMUMAB 50MG · INJECTABLE · INJECTION

Approval history

2025-10-22Labeling · Supplement 158 · standard — Letter ↗AP
2025-10-07Efficacy · Supplement 157 · standard — Label ↗AP
2025-10-01Labeling · Supplement 156 · standard — Label ↗AP
2025-04-18Labeling · Supplement 155 · standard — Label ↗AP
2023-11-16Labeling · Supplement 153 · standard — Letter ↗AP
2023-03-30Labeling · Supplement 150 · standard — Letter ↗AP
2019-09-24Labeling · Supplement 146 · standard — Label ↗AP
2018-03-06Labeling · Supplement 139 · standard — Label ↗AP
2018-02-09Labeling · Supplement 141 · standard — Label ↗AP
2017-11-13Labeling · Supplement 137 · standard — Label ↗AP
2017-06-22Efficacy · Supplement 133 · standard — Label ↗AP
2017-01-30Labeling · Supplement 135 · standard — Letter ↗AP
2016-01-08Labeling · Supplement 127 · standard — Label ↗AP
2015-06-16Labeling · Supplement 124 · standard — Label ↗AP
2014-12-19Labeling · Supplement 121 · standard — Letter ↗AP
2014-01-24Efficacy · Supplement 105 · standardAP
2013-12-27Labeling · Supplement 103 · standard — Label ↗AP
2013-11-13Labeling · Supplement 94 · standard — Label ↗AP
2013-05-15Efficacy · Supplement 79 · standard — Label ↗AP
2013-05-15Efficacy · Supplement 77 · standard — Label ↗AP
2013-05-15Efficacy · Supplement 78 · standard — Label ↗AP
2013-05-06Labeling · Supplement 86 · standard — Letter ↗AP
2013-04-23Labeling · Supplement 84 · standard — Label ↗AP
2012-11-23Labeling · Supplement 70 · standard — Label ↗AP
2011-12-26Labeling · Supplement 64 · standard — Label ↗AP
2011-09-07Labeling · Supplement 53 · standard — Letter ↗AP
2011-08-17Labeling · Supplement 38 · standard — Label ↗AP
2011-03-17Labeling · Supplement 20 · standard — Letter ↗AP
2010-12-22Labeling · Supplement 29 · standard — Letter ↗AP
2010-09-29Labeling · Supplement 33 · standard — Letter ↗AP
2010-07-29Labeling · Supplement 25 · standard — Label ↗AP
2009-11-18Labeling · Supplement 6 · standard — Letter ↗AP
2009-04-24Type 1 - New Molecular Entity · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Biologics industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →