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Novolog Mix 50/50

insulin aspart protamine and insulin aspart

351(a) Standalone BLA

Overview

Source: Purple Book
Proprietary name
Novolog Mix 50/50
Proper name
insulin aspart protamine and insulin aspart
Licence type
351(a)
BLA number
021810
Applicant
Novo Nordisk Inc.
Center
CDER
Presentations
2
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
150UNITS/3ML (50UNITS/ML); 150UNITS/3ML (50UNITS/ML) Injectable Suspension Subcutaneous Multi-Dose Cartridge Disc August 26, 2008
150UNITS/3ML (50UNITS/ML); 150UNITS/3ML (50UNITS/ML) Injectable Suspension Subcutaneous Autoinjector Disc August 26, 2008

Sources for this page

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