On this page
Tudriqev
vusolimogene oderparepvec-wtpg
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Tudriqev
Proper name
vusolimogene oderparepvec-wtpg
Licence type
351(a)
BLA number
125827
Applicant
Replimune, Inc.
Center
CBER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 10^6-10^7 PFU/mL | Suspension | Intratumor | Single-Dose Vial | Rx | August 6, 2026 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |