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FDA BLA · BLA761035

EMPLICITI

elotuzumab

Sponsor: BRISTOL MYERS SQUIBB

APPLICATION
BLA761035
TYPE
BLA
ORIGINAL APPROVAL
2015-11-30
LATEST ACTION
2022-03-22
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

EMPLICITIPrescription
ELOTUZUMAB 400MG · INJECTABLE · INJECTION
EMPLICITIPrescription
ELOTUZUMAB 300MG · INJECTABLE · INJECTION

Approval history

2022-03-22Efficacy · Supplement 15 · standard — Letter ↗AP
2019-10-28Efficacy · Supplement 10 · standard — Label ↗AP
2018-11-06Efficacy · Supplement 8 · priority — Label ↗AP
2017-05-11Efficacy · Supplement 5 · standard — Letter ↗AP
2015-11-30Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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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