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Bayrho-D, Hyprho-D, Hyperrho S/D Full Dose, Hyperrho S/D Mini-Dose

Rho(D) Immune Globulin (Human)

351(a) Standalone BLA

Overview

Source: Purple Book
Proprietary name
Bayrho-D, Hyprho-D, Hyperrho S/D Full Dose, Hyperrho S/D Mini-Dose
Proper name
Rho(D) Immune Globulin (Human)
Licence type
351(a)
BLA number
101141
Applicant
Grifols Therapeutics LLC
Center
CBER
Presentations
2
First licensure
—

Presentations

Source: Purple Book
Every strength and presentation recorded in the Purple Book for this product.
Strength Dosage form Route Presentation Status Licensed
1500IU Injection Intramuscular Pre-Filled Syringe Rx June 11, 1971
250IU Injection Intramuscular Pre-Filled Syringe Rx June 11, 1971

Sources for this page

Purple Book FDA Licence type, presentations, reference product, exclusivity