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FDA Drug/Biologics Approval BLA 125522 S-001, EVOLOCUMAB
FDA Drug/Biologics Approval BLA 125522 S-001, EVOLOCUMAB
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BLA 125522 S-001
Company: AMGEN INC
Drug Name: REPATHA
Active Ingredients: EVOLOCUMAB
Strength: 140MG/ML
Dosage Form/Route: INJECTABLE;INJECTION
Action Date: 08/27/2015
Marketing Status: Prescription
Submission Classification: ORIG-1
Company: AMGEN INC
Drug Name: REPATHA
Active Ingredients: EVOLOCUMAB
Strength: 140MG/ML
Dosage Form/Route: INJECTABLE;INJECTION
Action Date: 08/27/2015
Marketing Status: Prescription
Submission Classification: ORIG-1
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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