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FDA BLA · BLA761109

LYUMJEV

insulin lispro-aabc

Sponsor: ELI LILLY AND CO

APPLICATION
BLA761109
TYPE
BLA
ORIGINAL APPROVAL
2020-06-15
LATEST ACTION
2022-10-14
ROUTE
SUBCUTANEOUS, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

LYUMJEVPrescription
INSULIN LISPRO-AABC 200UNITS/ML(U-200) · INJECTABLE · INJECTION
LYUMJEVPrescription
INSULIN LISPRO-AABC 100UNITS/ML(U-100) · INJECTABLE · INJECTION

Approval history

2022-10-14Efficacy · Supplement 4 · standard — Letter ↗AP
2021-08-13Efficacy · Supplement 3 · standard — Letter ↗AP
2020-06-15Type 5 - New Formulation or New Manufacturer · Original · standard — 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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