Application 761150
- Type
- BLA
- Sponsor
- MACROGENICS INC
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761150 | Margenza | margetuximab-cmkb | 351(a) | Rx | 2026-10-01 |
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MARGENZA | MARGETUXIMAB-CMKB | INJECTABLE;INJECTION | 250MG/10ML(25MG/ML) | Yes | 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 |
|---|---|---|---|---|---|---|
| MARGENZA | MARGETUXIMAB-CMKB | TerSera Therapeutics LLC | 6a6d50c7-06ea-479c-83cc-f197a9e428c9 | 2025-02-11 | Boxed warning, Warnings, Adverse reactions | BLA761150 |
| MARGENZA | MARGETUXIMAB-CMKB | MacroGenics, Inc | e97a5872-eabf-463b-8f4c-5b5aed9c7bf0 | 2025-01-23 | Boxed warning, Warnings, Adverse reactions | BLA761150 74527-022 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.