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FDA BLA · BLA761038

LARTRUVO

Sponsor: ELI LILLY AND CO

APPLICATION
BLA761038
TYPE
BLA
ORIGINAL APPROVAL
2016-10-19
LATEST ACTION
2019-07-10
ROUTE
Injection
DOSAGE FORM
Injectable
MARKETING STATUS
Discontinued

Products

LARTRUVODiscontinued
OLARATUMAB 500MG/50ML · Injectable · Injection

Approval history

2019-07-10Manufacturing (CMC) · Supplement 1 — Review ↗AP
2018-08-09Manufacturing (CMC) · Supplement 9AP
2016-10-19Type 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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