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Novolog Mix 70/30

insulin aspart protamine and insulin aspart

351(a) Standalone BLA

Overview

Source: Purple Book
Proprietary name
Novolog Mix 70/30
Proper name
insulin aspart protamine and insulin aspart
Licence type
351(a)
BLA number
021172
Applicant
Novo Nordisk Inc.
Center
CDER
Presentations
4
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
210UNITS/3ML (70UNITS/ML); 90UNITS/3ML (30UNITS/ML) Injectable Suspension Subcutaneous Autoinjector Disc November 1, 2001
210UNITS/3ML (70UNITS/ML); 90UNITS/3ML (30UNITS/ML) Injectable Suspension Subcutaneous Pre-Filled Syringe Disc November 1, 2001
210UNITS/3ML (70UNITS/ML); 90UNITS/3ML (30UNITS/ML) Injectable Suspension Subcutaneous Autoinjector Rx May 3, 2002
700UNITS/10ML (70UNITS/ML); 300UNITS/10ML (30UNITS/ML) Injectable Suspension Subcutaneous Multi-Dose Vial Rx November 1, 2001

Sources for this page

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