On this page

Novolin 70/30

insulin isophane human and insulin human

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Novolin 70/30

Proper name

insulin isophane human and insulin human

Licence type

351(a)

BLA number

019991

Applicant

Novo Nordisk Inc.

Center

CDER

Presentations

First licensure

—

Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
300UNITS/10ML (30UNITS/ML); 700UNITS/10ML (70UNITS/ML)	Injection	Subcutaneous	Multi-Dose Vial	OTC	June 25, 1991
90UNITS/3ML (30UNITS/ML); 210UNITS/3ML (70UNITS/ML)	Injection	Subcutaneous	Autoinjector	OTC	June 1, 2018

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