Product Details for: Simulect
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
For Injection
Intravenous
20MG
Single-Dose Vial
351(a)
Simulect
Rx
002
For Injection
Intravenous
10MG
Single-Dose Vial
351(a)
Simulect
Rx
Proper Name
basiliximab
basiliximab
BLA Number
103764
103764
Applicant
Novartis Pharmaceuticals Corporation
Novartis Pharmaceuticals Corporation
Original Approval Date
May 12, 1998
May 12, 1998
Date of First Licensure