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Bayhep B, Hyperhep B S/D
Hepatitis B Immune Globulin (Human)
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Bayhep B, Hyperhep B S/D
Proper name
Hepatitis B Immune Globulin (Human)
Licence type
351(a)
BLA number
101146
Applicant
Grifols Therapeutics LLC
Center
CBER
Presentations
5
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 220IU/5ML | Injection | Intramuscular | Single-Dose Vial | Rx | September 23, 1977 |
| 220U/.5ML | Injection | Intramuscular | Pre-Filled Syringe | Rx | September 23, 1977 |
| 220U/.5ML | Injection | Intramuscular | Single-Dose Vial | Rx | September 23, 1977 |
| 220U/ML | Injection | Intramuscular | Pre-Filled Syringe | Rx | September 23, 1977 |
| 220U/ML | Injection | Intramuscular | Single-Dose Vial | Rx | September 23, 1977 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |