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FDA Drug/Biologics Approval BLA 103948 S-5151, ALEMTUZUMAB
FDA Drug/Biologics Approval BLA 103948 S-5151, ALEMTUZUMAB
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BLA 103948 S-5151
Company: GENZYME
Drug Name: LEMTRADA
Active Ingredients: ALEMTUZUMAB
Strength: 12MG/1.2ML (10MG/ML)
Dosage Form/Route: INJECTABLE;INJECTION
Action Date: 05/07/2001
Marketing Status: Prescription
Submission Classification: ORIG-1
Company: GENZYME
Drug Name: LEMTRADA
Active Ingredients: ALEMTUZUMAB
Strength: 12MG/1.2ML (10MG/ML)
Dosage Form/Route: INJECTABLE;INJECTION
Action Date: 05/07/2001
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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