Product Details for: Praluent

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Subcutaneous
75MG/ML
Autoinjector
351(a)
Praluent
Rx
002
Injection
Subcutaneous
150MG/ML
Autoinjector
351(a)
Praluent
Rx
003
Injection
Subcutaneous
75MG/ML
Pre-Filled Syringe
351(a)
Praluent
Disc
004
Injection
Subcutaneous
150MG/ML
Pre-Filled Syringe
351(a)
Praluent
Disc
Proper Name
alirocumab
BLA Number
125559
Applicant
Regeneron Pharmaceuticals, Inc.
Original Approval Date
July 24, 2015
Date of First Licensure
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