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Trodelvy
sacituzumab govitecan-hziy
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Trodelvy
Proper name
sacituzumab govitecan-hziy
Licence type
351(a)
BLA number
761115
Applicant
Gilead Sciences, Inc.
Center
CDER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 180MG | For Injection | Intravenous | Single-Dose Vial | Rx | April 22, 2020 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |