Product Details for: Palynziq

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Subcutaneous
2.5MG/0.5ML
Pre-Filled Syringe
351(a)
Palynziq
Rx
002
Injection
Subcutaneous
10MG/0.5ML
Pre-Filled Syringe
351(a)
Palynziq
Rx
003
Injection
Subcutaneous
20MG/ML
Pre-Filled Syringe
351(a)
Palynziq
Rx
Proper Name
pegvaliase-pqpz
BLA Number
761079
Applicant
BioMarin Pharmaceutical Inc.
Original Approval Date
May 24, 2018
Date of First Licensure
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