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FDA Drug/Biologics Approval BLA 103979 S-5309, AGALSIDASE BETA
FDA Drug/Biologics Approval BLA 103979 S-5309, AGALSIDASE BETA
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BLA 103979 S-5309
Company: GENZYME
Drug Name: FABRAZYME
Active Ingredients: AGALSIDASE BETA
Strength: 35MG/VIAL
Dosage Form/Route: VIAL; INTRAVENOUS
Action Date: 04/24/2003
Marketing Status: Prescription
Submission Classification: ORIG-1
Company: GENZYME
Drug Name: FABRAZYME
Active Ingredients: AGALSIDASE BETA
Strength: 35MG/VIAL
Dosage Form/Route: VIAL; INTRAVENOUS
Action Date: 04/24/2003
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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