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Ryzodeg 70/30

insulin degludec and insulin aspart

351(a) Standalone BLA

Overview

Source: Purple Book
Proprietary name
Ryzodeg 70/30
Proper name
insulin degludec and insulin aspart
Licence type
351(a)
BLA number
203313
Applicant
Novo Nordisk Inc.
Center
CDER
Presentations
1
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); 90UNIT/3ML (30UNITS/ML) Injection Subcutaneous Autoinjector Disc September 25, 2015

Sources for this page

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