← FDA DRUG APPROVALS

FDA BLA · BLA761240

LOQTORZI

toripalimab-tpzi

Sponsor: COHERUS BIOSCIENCES INC

APPLICATION
BLA761240
TYPE
BLA
ORIGINAL APPROVAL
2023-10-27
LATEST ACTION
2024-10-30
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

LOQTORZIPrescription
TORIPALIMAB-TPZI 240MG/6ML(40MG/ML) · INJECTABLE · INJECTION

Approval history

2024-10-30Labeling · Supplement 2 · standard — Letter ↗AP
2024-04-22Labeling · Supplement 1 · standard — Letter ↗AP
2023-10-27Type 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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