Product Details for: Krystexxa

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intravenous
8MG/ML
Single-Dose Vial
351(a)
Krystexxa
Rx
002
Injection
Intravenous
8MG/50ML (0.16MG/ML)
Single-Dose Vial
351(a)
Krystexxa
Rx
Proper Name
pegloticase
BLA Number
125293
Applicant
Horizon Therapeutics Ireland DAC
Original Approval Date
September 14, 2010
Date of First Licensure
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