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FDA Drug/Biologics Approval BLA 761055 S-016, DUPILUMAB
FDA Drug/Biologics Approval BLA 761055 S-016, DUPILUMAB
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BLA 761055 S-016
Company: REGENERON PHARMACEUTICALS
Drug Name: DUPIXENT
Active Ingredients: DUPILUMAB
Strength: 150MG/ML
Dosage Form/Route: INJECTABLE; INJECTION
Action Date: 03/28/2017
Marketing Status: Prescription
Submission Classification: ORIG-1
Company: REGENERON PHARMACEUTICALS
Drug Name: DUPIXENT
Active Ingredients: DUPILUMAB
Strength: 150MG/ML
Dosage Form/Route: INJECTABLE; INJECTION
Action Date: 03/28/2017
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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