Product Details for: Rhophylac

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intramuscular
1500IU/ML
Pre-Filled Syringe
351(a)
Rhophylac
Rx
002
Injection
Intravenous
1500IU/ML
Pre-Filled Syringe
351(a)
Rhophylac
Rx
Proper Name
Rho(D) Immune Globulin Intravenous (Human)
BLA Number
125070
Applicant
CSL Behring AG
Original Approval Date
February 12, 2004
Date of First Licensure