Skip to content
Application 761150
- Type
- BLA
- Sponsor
- MACROGENICS INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | MARGENZA | MARGETUXIMAB-CMKB | INJECTABLE;INJECTION | 250MG/10ML(25MG/ML) | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 74527-022 | MARGENZA | margetuximab-cmkb | MacroGenics, Inc | BLA | Current |
| 74527-022 | MARGENZA | margetuximab-cmkb | MacroGenics, Inc | BLA | Current |
| 74527-022 | MARGENZA | margetuximab-cmkb | MacroGenics, Inc | BLA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 80878 | SUPPL | 2025-01-21 |
| 74384 | SUPPL | 2023-05-26 |
| 74379 | SUPPL | 2023-05-26 |
| 65915 | ORIG | 2021-01-15 |
| 65647 | ORIG | 2020-12-21 |
| 65604 | ORIG | 2020-12-17 |