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Micrhogam, Rhogam
Rho(D) Immune Globulin (Human)
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Micrhogam, Rhogam
Proper name
Rho(D) Immune Globulin (Human)
Licence type
351(a)
BLA number
103777
Applicant
Kedrion Biopharma Inc.
Center
CBER
Presentations
2
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 300UG | Injection | Intramuscular | Pre-Filled Syringe | Rx | April 23, 1998 |
| 50UG | Injection | Intramuscular | Pre-Filled Syringe | Disc | April 23, 1998 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |