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FDA Drug/Biologics Approval BLA 125320 S-005, DENOSUMAB
FDA Drug/Biologics Approval BLA 125320 S-005, DENOSUMAB
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BLA 125320 S-005
Company: AMGEN
Drug Name: XGEVA
Active Ingredients: DENOSUMAB
Strength: 70MG/ML
Dosage Form/Route: INJECTABLE; SUBCUTANEOUS
Action Date: 06/01/2010
Marketing Status: Prescription
Submission Classification: ORIG-1
Company: AMGEN
Drug Name: XGEVA
Active Ingredients: DENOSUMAB
Strength: 70MG/ML
Dosage Form/Route: INJECTABLE; SUBCUTANEOUS
Action Date: 06/01/2010
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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