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 | 2026-06-01 |
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#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 |