Application 761238
- Type
- BLA
- Sponsor
- TG THERAPEUTICS, INC
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761238 | Briumvi | ublituximab-xiiy | 351(a) | Rx | 2026-09-01 |
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BRIUMVI | UBLITUXIMAB | INJECTABLE;INTRAVENOUS | 25 MG/ML | No | No |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| BRIUMVI | UBLITUXIMAB | TG Therapeutics, Inc. | 3a77cd8c-811b-407c-9140-d0c5c26435c2 | 2026-02-19 | Warnings, Adverse reactions | BLA761238 73150-150 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 73150-150 | BRIUMVI | ublituximab | TG Therapeutics, Inc. | BLA | Current |