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Levemir

insulin detemir

351(a) Standalone BLA

Overview

Source: Purple Book
Proprietary name
Levemir
Proper name
insulin detemir
Licence type
351(a)
BLA number
021536
Applicant
Novo Nordisk Inc.
Center
CDER
Presentations
5
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) Injection Subcutaneous Multi-Dose Vial Disc June 16, 2005
300UNITS/3ML (100UNITS/ML) Injection Subcutaneous Autoinjector Disc June 16, 2005
300UNITS/3ML (100UNITS/ML) Injection Subcutaneous Autoinjector Disc June 16, 2005
300UNITS/3ML (100UNITS/ML) Injection Subcutaneous Multi-Dose Cartridge Disc June 16, 2005
300UNITS/3ML (100UNITS/ML) Injection Subcutaneous Autoinjector Disc October 31, 2013

Sources for this page

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