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Humalog Mix 75/25

insulin lispro protamine and insulin lispro

351(a) Standalone BLA

Overview

Source: Purple Book
Proprietary name
Humalog Mix 75/25
Proper name
insulin lispro protamine and insulin lispro
Licence type
351(a)
BLA number
021017
Applicant
Eli Lilly and Company
Center
CDER
Presentations
3
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
225UNITS/3ML (75UNITS/ML); 75UNITS/3ML (25UNITS/ML) Injectable Suspension Subcutaneous Autoinjector Rx September 6, 2007
225UNITS/3ML (75UNITS/ML); 75UNITS/3ML (25UNITS/ML) Injectable Suspension Subcutaneous Autoinjector Disc December 22, 1999
750UNITS/10ML (75UNITS/ML); 250UNITS/10ML (25UNITS/ML) Injectable Suspension Subcutaneous Multi-Dose Vial Rx December 22, 1999

Sources for this page

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