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Jemperli
dostarlimab-gxly
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Jemperli
Proper name
dostarlimab-gxly
Licence type
351(a)
BLA number
761174
Applicant
GlaxoSmithKline LLC
Center
CDER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 500MG/10ML (50MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | April 22, 2021 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |