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Kimmtrak
tebentafusp-tebn
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Kimmtrak
Proper name
tebentafusp-tebn
Licence type
351(a)
BLA number
761228
Applicant
Immunocore Limited
Center
CDER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 100MCG/0.5ML | Injection | Intravenous | Single-Dose Vial | Rx | January 25, 2022 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | January 25, 2029 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |