FDA Approval for BRIUMVI issued to TG THERAPEUTICS, INC
$TGTX
Biotechnology: Pharmaceutical Preparations
Health Care
Biologic License Application (BLA): 761238
Company: TG THERAPEUTICS, INC
Company: TG THERAPEUTICS, INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BRIUMVI | UBLITUXIMAB | 25 MG/ML | INJECTABLE;INTRAVENOUS | Prescription | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/28/2022 | ORIG-1 | Approval | N/A |
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