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Xultophy 100/3.6

insulin degludec and liraglutide

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Xultophy 100/3.6

Proper name

insulin degludec and liraglutide

Licence type

351(a)

BLA number

208583

Applicant

Novo Nordisk Inc.

Center

CDER

Presentations

First licensure

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Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
300UNITS/3ML (100UNITS/ML); 10.8MG/3ML (3.6MG/ML)	Injection	Subcutaneous	Autoinjector	Rx	November 21, 2016

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