Product Details for: Soliris
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intravenous
300MG/30ML (10MG/ML)
Single-Dose Vial
351(a)
Soliris
Rx
Proper Name
eculizumab
eculizumab
BLA Number
125166
125166
Applicant
Alexion Pharmaceuticals, Inc.
Alexion Pharmaceuticals, Inc.
Original Approval Date
March 16, 2007
March 16, 2007
Date of First Licensure