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Humulin N

insulin isophane human

351(a) Standalone BLA

Overview

Source: Purple Book
Proprietary name
Humulin N
Proper name
insulin isophane human
Licence type
351(a)
BLA number
018781
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
1,000UNITS/10ML (100UNITS/ML) Injectable Suspension Subcutaneous Multi-Dose Vial OTC October 28, 1982
300UNITS/3ML (100UNITS/ML) Injectable Suspension Subcutaneous Multi-Dose Vial OTC October 28, 1982
300UNITS/3ML (100UNITS/ML) Injectable Suspension Subcutaneous Autoinjector OTC November 7, 2013

Sources for this page

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