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Esperoct
Antihemophilic Factor (Recombinant), GlycoPEGylated-exei
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Esperoct
Proper name
Antihemophilic Factor (Recombinant), GlycoPEGylated-exei
Licence type
351(a)
BLA number
125671
Applicant
Novo Nordisk Inc.
Center
CBER
Presentations
7
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 1000IU | For Injection | Intravenous | Single-Dose Vial | Rx | February 19, 2019 |
| 1500IU | For Injection | Intravenous | Single-Dose Vial | Rx | February 19, 2019 |
| 2000IU | For Injection | Intravenous | Single-Dose Vial | Rx | February 19, 2019 |
| 3000IU | For Injection | Intravenous | Single-Dose Vial | Rx | February 19, 2019 |
| 4000IU | For Injection | Intravenous | Single-Dose Vial | Rx | July 3, 2024 |
| 5000IU | For Injection | Intravenous | Single-Dose Vial | Rx | July 3, 2024 |
| 500IU | For Injection | Intravenous | Single-Dose Vial | Rx | February 19, 2019 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |