OpenRx Open Medications Explorer
© 2026 OpenRx · public-domain U.S. government data
On this page

Datroway

datopotamab deruxtecan-dlnk

351(a) Standalone BLA

Overview

Source: Purple Book
Proprietary name
Datroway
Proper name
datopotamab deruxtecan-dlnk
Licence type
351(a)
BLA number
761394
Applicant
Daiichi Sankyo, Inc
Center
CDER
Presentations
1
First licensure
—

Presentations

Source: Purple Book
Every strength and presentation recorded in the Purple Book for this product.
Strength Dosage form Route Presentation Status Licensed
100MG Injection Intravenous Single-Dose Vial Rx January 17, 2025

Sources for this page

Purple Book FDA Licence type, presentations, reference product, exclusivity