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Taltz

ixekizumab

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Taltz

Proper name

ixekizumab

Licence type

351(a)

BLA number

125521

Applicant

Eli Lilly and Company

Center

CDER

Presentations

4

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
20MG/0.25ML	Injection	Subcutaneous	Pre-Filled Syringe	Rx	August 20, 2024
40MG/0.5ML	Injection	Subcutaneous	Pre-Filled Syringe	Rx	August 20, 2024
80MG/ML	Injection	Subcutaneous	Autoinjector	Rx	March 22, 2016
80MG/ML	Injection	Subcutaneous	Pre-Filled Syringe	Rx	March 22, 2016

Sources for this page

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