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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intravenous
1,700MG/34ML (50MG/ML)
Single-Dose Vial
351(a)
Rx
Proper Name
raxibacumab
BLA Number
125349
Applicant
Emergent Manufacturing Operations Baltimore LLC
Original Approval Date
December 14, 2012
Date of First Licensure