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Lyumjev

insulin lispro-aabc

351(a) Standalone BLA

Overview

Source: Purple Book
Proprietary name
Lyumjev
Proper name
insulin lispro-aabc
Licence type
351(a)
BLA number
761109
Applicant
Eli Lilly and Company
Center
CDER
Presentations
6
First licensure
—

Presentations

Source: Purple Book
Every strength and presentation recorded in the Purple Book for this product.
Strength Dosage form Route Presentation Status Licensed
1,000UNITS/10ML (100UNITS/ML) Injection Intravenous, Subcutaneous Multi-Dose Vial Rx June 15, 2020
300UNITS/3ML (100UNITS/ML) Injection Intravenous, Subcutaneous Autoinjector Disc June 15, 2020
300UNITS/3ML (100UNITS/ML) Injection Intravenous, Subcutaneous Autoinjector Rx June 15, 2020
300UNITS/3ML (100UNITS/ML) Injection Intravenous, Subcutaneous Autoinjector Rx June 15, 2020
300UNITS/3ML (100UNITS/ML) Injection Intravenous, Subcutaneous Multi-Dose Cartridge Disc June 15, 2020
600UNITS/3ML (200UNITS/ML) Injection Intravenous, Subcutaneous Autoinjector Rx June 15, 2020

Sources for this page

Purple Book FDA Licence type, presentations, reference product, exclusivity