← FDA DRUG APPROVALS

FDA BLA · BLA103705

RITUXAN

rituximab

Sponsor: GENENTECH

APPLICATION
BLA103705
TYPE
BLA
ORIGINAL APPROVAL
1997-11-26
LATEST ACTION
2021-12-17
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

RITUXANPrescription
RITUXIMAB 500MG/50ML (10MG/ML) · SOLUTION · INTRAVENOUS
RITUXANPrescription
RITUXIMAB 100MG/10ML (10MG/ML) · SOLUTION · INTRAVENOUS

Approval history

2021-12-17Labeling · Supplement 5467 · standard — Label ↗AP
2021-12-02Efficacy · Supplement 5465 · priority — Label ↗AP
2021-06-30Labeling · Supplement 5464 · standard — Label ↗AP
2020-08-28Efficacy · Supplement 5460 · standard — Letter ↗AP
2020-03-13Labeling · Supplement 5458 · standard — Letter ↗AP
2020-01-23Labeling · Supplement 5461 · standard — Letter ↗AP
2019-11-25Labeling · Supplement 5459 · standard — Letter ↗AP
2019-09-27Efficacy · Supplement 5457 · priority — Letter ↗AP
2019-01-25Efficacy · Supplement 5454 · standard — Label ↗AP
2018-10-18Efficacy · Supplement 5451 · standard — Label ↗AP
2018-06-07Efficacy · Supplement 5450 · priority — Label ↗AP
2018-04-03Labeling · Supplement 5453 · standard — Label ↗AP
2014-08-12Labeling · Supplement 5432 · standard — Label ↗AP
2013-09-24Labeling · Supplement 5414 · standard — Letter ↗AP
2013-05-09Labeling · Supplement 5409 · standard — Letter ↗AP
2012-10-19Efficacy · Supplement 5367 · standard — Label ↗AP
2012-10-19Labeling · Supplement 5388 — Label ↗AP
2012-07-13Labeling · Supplement 5373 · standard — Label ↗AP
2012-04-13Labeling · Supplement 5370 · standard — Label ↗AP
2012-02-17Labeling · Supplement 5362 · standard — Label ↗AP
2011-04-19Efficacy · Supplement 5344 · priority — Review ↗AP
2011-01-28Efficacy · Supplement 5332 · standard — Letter ↗AP
2011-01-06Labeling · Supplement 5343 · standard — Label ↗AP
2010-10-06Labeling · Supplement 5334 · standardAP
2010-02-18Efficacy · Supplement 5312 · priority — Label ↗AP
2010-02-18Efficacy · Supplement 5311 · priority — Label ↗AP
2009-10-16Efficacy · Supplement 5299 · standard — Label ↗AP
2009-09-22Labeling · Supplement 5310 · standardAP
2008-09-08Labeling · Supplement 5285 · standard — Letter ↗AP
2008-09-08Supplement · Supplement 5291 — Letter ↗AP
2008-01-25Efficacy · Supplement 5256 · standard — Label ↗AP
2008-01-24Labeling · Supplement 5263 · standard — Label ↗AP
2007-09-28Labeling · Supplement 5262 · standard — Letter ↗AP
2007-08-22Labeling · Supplement 5259 · standard — Letter ↗AP
2007-02-21Labeling · Supplement 5247 · standard — Label ↗AP
2006-09-29Efficacy · Supplement 5231 · priority — Label ↗AP
2006-09-29Efficacy · Supplement 5230 · priority — Label ↗AP
2006-02-28Efficacy · Supplement 5211 · priority — Letter ↗AP
2006-02-10Efficacy · Supplement 5209 · priority — Label ↗AP
1997-11-26Type 1 - New Molecular Entity · Original · priority — 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 →