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Product Number | Dosage Form | Route of Administration | Strength | Product Presentation | License Type | Proprietary Name | Marketing Status |
---|---|---|---|---|---|---|---|
001 | Injection | Subcutaneous | 300MG/2ML (150MG/ML) | Single-Dose Vial | 351(a) | Takhzyro | Rx |
002 | Injection | Subcutaneous | 300MG/2ML (150MG/ML) | Pre-Filled Syringe | 351(a) | Takhzyro | Rx |
003 | Injection | Subcutaneous | 150MG/1ML (150MG/ML) | Pre-Filled Syringe | 351(a) | Takhzyro | Rx |
Proper Name
lanadelumab-flyo
BLA Number
761090
Applicant
Takeda Pharmaceuticals U.S.A., Inc.
Original Approval Date
August 23, 2018
Date of First Licensure