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FDA BLA · BLA761103

RUXIENCE

rituximab-pvvr

Sponsor: PFIZER INC

APPLICATION
BLA761103
TYPE
BLA
ORIGINAL APPROVAL
2019-07-23
LATEST ACTION
2025-06-09
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

RUXIENCEPrescription
RITUXIMAB-PVVR 100MG/10ML(10MG/ML) · INJECTABLE · INJECTION
RUXIENCEPrescription
RITUXIMAB-PVVR 500MG/50ML(10MG/ML) · INJECTABLE · INJECTION

Approval history

2025-06-09BIOSIMILAR · Supplement 14 — Label ↗AP
2023-10-16Labeling · Supplement 11 · standard — Letter ↗AP
2021-11-15Efficacy · Supplement 5 · standard — Label ↗AP
2020-05-26Efficacy · Supplement 3 · standard — Label ↗AP
2019-07-23Type 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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