Application 761238
- Type
- BLA
- Sponsor
- TG THERAPEUTICS, INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | BRIUMVI | UBLITUXIMAB | INJECTABLE;INTRAVENOUS | 25 MG/ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 73150-150 | BRIUMVI | ublituximab | TG Therapeutics, Inc. | BLA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 84813 | SUPPL | 2026-01-22 |
| 84804 | SUPPL | 2026-01-21 |
| 83149 | SUPPL | 2025-08-20 |
| 83148 | SUPPL | 2025-08-20 |
| 83139 | SUPPL | 2025-08-19 |
| 83138 | SUPPL | 2025-08-19 |
| 80061 | SUPPL | 2024-11-01 |
| 80055 | SUPPL | 2024-10-31 |
| 73390 | ORIG | 2023-02-06 |
| 73061 | ORIG | 2022-12-29 |
| 73056 | ORIG | 2022-12-28 |