Product Details for: Tepezza
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
For Injection
Intravenous
500MG
Single-Dose Vial
351(a)
Tepezza
Rx
Proper Name
teprotumumab-trbw
teprotumumab-trbw
BLA Number
761143
761143
Applicant
Horizon Therapeutics Ireland DAC
Horizon Therapeutics Ireland DAC
Original Approval Date
January 21, 2020
January 21, 2020
Date of First Licensure