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Epkinly
epcoritamab-bysp
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Epkinly
Proper name
epcoritamab-bysp
Licence type
351(a)
BLA number
761324
Applicant
Genmab US, Inc.
Center
CDER
Presentations
2
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 48MG/0.8ML | Injection | Subcutaneous | Single-Dose Vial | Rx | May 19, 2023 |
| 4MG/0.8ML | Injection | Subcutaneous | Single-Dose Vial | Rx | May 19, 2023 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | June 26, 1931 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |