Product Details for: Tecvayli Product Label Grayed out Product Label links indicate that there is no product label available for the product.
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Product Number | Dosage Form | Route of Administration | Strength | Product Presentation | License Type | Proprietary Name | Marketing Status |
---|---|---|---|---|---|---|---|
001 | Injection | Subcutaneous | 30MG/3ML (10MG/ML) | Single-Dose Vial | 351(a) | Tecvayli | Rx |
002 | Injection | Subcutaneous | 153MG/1.7ML (90MG/ML) | Single-Dose Vial | 351(a) | Tecvayli | Rx |
Proper Name
teclistamab-cqyv
BLA Number
761291
Applicant
Janssen Biotech, Inc.
Original Approval Date
October 25, 2022
Date of First Licensure