Skip to contentApplication 761269
- Type
- BLA
- Sponsor
- EISAI INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | LEQEMBI | LECANEMAB-IRMB | INJECTABLE;INJECTION | 500MG/5ML | Yes | No |
| 002 | LEQEMBI | LECANEMAB-IRMB | INJECTABLE;INJECTION | 200MG/2ML | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 62856-212 | LEQEMBI | lecanemab | Eisai Inc. | BLA | Current |
| 62856-215 | LEQEMBI | lecanemab | Eisai Inc. | BLA | Current |