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Rhophylac
Rho(D) Immune Globulin Intravenous (Human)
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Rhophylac
Proper name
Rho(D) Immune Globulin Intravenous (Human)
Licence type
351(a)
BLA number
125070
Applicant
CSL Behring AG
Center
CBER
Presentations
2
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 1500IU/ML | Injection | Intramuscular | Pre-Filled Syringe | Rx | February 12, 2004 |
| 1500IU/ML | Injection | Intravenous | Pre-Filled Syringe | Rx | February 12, 2004 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |