APPLICATION
BLA761270
TYPE
BLA
ORIGINAL APPROVAL
2022-11-10
LATEST ACTION
2022-11-10
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
2022-11-10Type 9 - New indication submitted as distinct BLA, consolidated · Original · standard — Medication Guide ↗AP
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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