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FDA Drug/Biologics Approval BLA 125166 S-431, ECULIZUMAB
FDA Drug/Biologics Approval BLA 125166 S-431, ECULIZUMAB
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BLA 125166 S-431
Company: ALEXION PHARM
Drug Name: SOLIRIS
Active Ingredients: ECULIZUMAB
Strength: 300MG
Dosage Form/Route: INJECTABLE; IV (INFUSION)
Action Date: 03/16/2007
Marketing Status: Prescription
Submission Classification: ORIG-1
Company: ALEXION PHARM
Drug Name: SOLIRIS
Active Ingredients: ECULIZUMAB
Strength: 300MG
Dosage Form/Route: INJECTABLE; IV (INFUSION)
Action Date: 03/16/2007
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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