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Purple Book
Database of Licensed Biological Products

Product Details for: Tecvayli
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 Subcutaneous30MG/3ML (10MG/ML)Single-Dose Vial351(a)TecvayliRx
002Injection Subcutaneous153MG/1.7ML (90MG/ML)Single-Dose Vial351(a)TecvayliRx

Proper Name
teclistamab-cqyv

BLA Number
761291

Applicant
Janssen Biotech, Inc.

Original Approval Date
October 25, 2022

Date of First Licensure