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Imdelltra
tarlatamab-dlle
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Imdelltra
Proper name
tarlatamab-dlle
Licence type
351(a)
BLA number
761344
Applicant
Amgen Inc.
Center
CDER
Presentations
2
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 10MG | Injection | Intravenous | Single-Dose Vial | Rx | May 16, 2024 |
| 1MG | Injection | Intravenous | Single-Dose Vial | Rx | May 16, 2024 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | May 16, 1931 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |