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FDA BLA · BLA761088

TRUXIMA

rituximab-abbs

Sponsor: CELLTRION INC

APPLICATION
BLA761088
TYPE
BLA
ORIGINAL APPROVAL
2018-11-28
LATEST ACTION
2026-06-29
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

TRUXIMAPrescription
RITUXIMAB-ABBS 500MG/50ML(10MG/ML) · INJECTABLE · INJECTION
TRUXIMAPrescription
RITUXIMAB-ABBS 100MG/10ML(10MG/ML) · INJECTABLE · INJECTION

Approval history

2026-06-29Bioequivalence · Supplement 35 — Letter ↗AP
2025-06-09BIOSIMILAR · Supplement 32 — Letter ↗AP
2022-02-04Labeling · Supplement 18 · standard — Letter ↗AP
2020-05-29Labeling · Supplement 9 · standard — Letter ↗AP
2019-12-18Efficacy · Supplement 5 · standard — Label ↗AP
2019-12-18Efficacy · Supplement 6 · standard — Label ↗AP
2019-05-23Efficacy · Supplement 1 · standard — Label ↗AP
2019-05-23Efficacy · Supplement 2 · standard — Label ↗AP
2018-11-28Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗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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