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Bayrab, Hyperrab
Rabies Immune Globulin (Human)
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Bayrab, Hyperrab
Proper name
Rabies Immune Globulin (Human)
Licence type
351(a)
BLA number
101144
Applicant
Grifols Therapeutics LLC
Center
CBER
Presentations
2
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 1500IU/5 ML | Injection | Intramuscular | Single-Dose Vial | Rx | June 12, 1974 |
| 300IU/ML | Injection | Intramuscular | Single-Dose Vial | Rx | June 12, 1974 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |