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FDA BLA · BLA761289

IMJUDO

tremelimumab

Sponsor: ASTRAZENECA AB

APPLICATION
BLA761289
TYPE
BLA
ORIGINAL APPROVAL
2022-10-21
LATEST ACTION
2024-07-24
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

IMJUDOPrescription
TREMELIMUMAB-ACTL 25MG/1.25ML(20MG/ML) · INJECTABLE · INTRAVENOUS
IMJUDOPrescription
TREMELIMUMAB-ACTL 300MG/15ML(20MG/ML) · INJECTABLE · INTRAVENOUS

Approval history

2024-07-24Labeling · Supplement 6 · standard — Letter ↗AP
2024-01-25Labeling · Supplement 4 · standard — Label ↗AP
2023-06-14Labeling · Supplement 2 · standard — Letter ↗AP
2022-10-28Labeling · Supplement 1 · standard — Letter ↗AP
2022-10-21Type 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.

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