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Purple Book
Database of Licensed Biological Products

Product Details for: Takhzyro
Product Label Grayed out Product Label links indicate that there is no product label available for the product.

Product NumberDosage FormRoute of AdministrationStrengthProduct PresentationLicense TypeProprietary NameMarketing Status
001Injection Subcutaneous300MG/2ML (150MG/ML)Single-Dose Vial351(a)TakhzyroRx
002Injection Subcutaneous300MG/2ML (150MG/ML)Pre-Filled Syringe351(a)TakhzyroRx
003Injection Subcutaneous150MG/1ML (150MG/ML)Pre-Filled Syringe351(a)TakhzyroRx

Proper Name
lanadelumab-flyo

BLA Number
761090

Applicant
Takeda Pharmaceuticals U.S.A., Inc.

Original Approval Date
August 23, 2018

Date of First Licensure