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FDA BLA · BLA761104

LUMOXITI

Sponsor: INNATE PHARMA

APPLICATION
BLA761104
TYPE
BLA
ORIGINAL APPROVAL
2018-09-13
LATEST ACTION
2020-08-20
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

LUMOXITIPrescription
MOXETUMOMAB PASUDOTOX-TDFK 1MG/VIAL · INJECTABLE · INJECTION

Approval history

2020-08-20Labeling · Supplement 3 · standard — Label ↗AP
2019-01-25Labeling · Supplement 1 · standard — Label ↗AP
2018-09-13Type 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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