Application 761310
- Type
- BLA
- Sponsor
- IMMUNOGEN INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MIRVETUXIMAB SORAVTANSINE | MIRVETUXIMAB SORAVTANSINE | INJECTABLE;INJECTION | 100mg/20mL single-dose vial | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 72903-853 | ELAHERE | mirvetuximab soravtansine | ImmunoGen, Inc. | BLA | Current |