Product Details for: Repatha

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Subcutaneous
140MG/ML
Pre-Filled Syringe
351(a)
Repatha
Rx
002
Injection
Subcutaneous
140MG/ML
Autoinjector
351(a)
Repatha
Disc
003
Injection
Subcutaneous
420MG/3.5ML
Autoinjector
351(a)
Repatha
Disc
004
Injection
Subcutaneous
140MG/ML
Autoinjector
351(a)
Repatha
Rx
Proper Name
evolocumab
BLA Number
125522
Applicant
Amgen Inc.
Original Approval Date
August 27, 2015
Date of First Licensure
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