Product Details for: Bayrho-D, Hyprho-D, Hyperrho S/D Full Dose, Hyperrho S/D Mini-Dose

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intramuscular
1500IU
Pre-Filled Syringe
351(a)
Bayrho-D, Hyprho-D, Hyperrho S/D Full Dose, Hyperrho S/D Mini-Dose
Rx
002
Injection
Intramuscular
250IU
Pre-Filled Syringe
351(a)
Bayrho-D, Hyprho-D, Hyperrho S/D Full Dose, Hyperrho S/D Mini-Dose
Rx
Proper Name
Rho(D) Immune Globulin (Human)
BLA Number
101141
Applicant
Grifols Therapeutics LLC
Original Approval Date
June 11, 1971
Date of First Licensure