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Rebinyn
Coagulation Factor IX (Recombinant), GlycoPEGylated
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Rebinyn
Proper name
Coagulation Factor IX (Recombinant), GlycoPEGylated
Licence type
351(a)
BLA number
125611
Applicant
Novo Nordisk Inc.
Center
CBER
Presentations
4
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 1000IU | For Injection | Intravenous | Single-Dose Vial | Rx | May 31, 2017 |
| 2000IU | For Injection | Intravenous | Single-Dose Vial | Rx | May 31, 2017 |
| 3000IU | For Injection | Intravenous | Single-Dose Vial | Rx | August 11, 2022 |
| 500IU | For Injection | Intravenous | Single-Dose Vial | Rx | May 31, 2017 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |