Skip to contentApplication 212028
- Type
- NDA
- Sponsor
- EISAI INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | DAYVIGO | LEMBOREXANT | TABLET;ORAL | 5MG | Yes | No |
| 002 | DAYVIGO | LEMBOREXANT | TABLET;ORAL | 10MG | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 62856-405 | DAYVIGO | lemborexant | Eisai Inc. | NDA | Current |
| 62856-405 | DAYVIGO | lemborexant | Eisai Inc. | NDA | Current |
| 62856-405 | DAYVIGO | lemborexant | Eisai Inc. | NDA | Current |
| 62856-405 | DAYVIGO | lemborexant | Eisai Inc. | NDA | Current |
| 62856-405 | DAYVIGO | lemborexant | Eisai Inc. | NDA | Current |
| 62856-405 | DAYVIGO | lemborexant | Eisai Inc. | NDA | Current |
| 62856-405 | DAYVIGO | lemborexant | Eisai Inc. | NDA | Current |
| 62856-405 | DAYVIGO | lemborexant | Eisai Inc. | NDA | Current |
| 62856-405 | DAYVIGO | lemborexant | Eisai Inc. | NDA | Current |
| 62856-405 | DAYVIGO | lemborexant | Eisai Inc. | NDA | Current |
| 62856-410 | DAYVIGO | lemborexant | Eisai Inc. | NDA | Current |
| 62856-410 | DAYVIGO | lemborexant | Eisai Inc. | NDA | Current |
| 62856-410 | DAYVIGO | lemborexant | Eisai Inc. | NDA | Current |
| 62856-410 | DAYVIGO | lemborexant | Eisai Inc. | NDA | Current |
| 62856-410 | DAYVIGO | lemborexant | Eisai Inc. | NDA | Current |
| 62856-410 | DAYVIGO | lemborexant | Eisai Inc. | NDA | Current |
| 62856-410 | DAYVIGO | lemborexant | Eisai Inc. | NDA | Current |
| 62856-410 | DAYVIGO | lemborexant | Eisai Inc. | NDA | Current |
| 62856-410 | DAYVIGO | lemborexant | Eisai Inc. | NDA | Current |
| 62856-410 | DAYVIGO | lemborexant | Eisai Inc. | NDA | Current |
| 62856-455 | DAYVIGO | lemborexant | Eisai Inc. | NDA | Current |
| 62856-455 | DAYVIGO | lemborexant | Eisai Inc. | NDA | Current |
| 62856-455 | DAYVIGO | lemborexant | Eisai Inc. | NDA | Current |
| 62856-455 | DAYVIGO | lemborexant | Eisai Inc. | NDA | Current |
| 62856-455 | DAYVIGO | lemborexant | Eisai Inc. | NDA | Current |
| 62856-455 | DAYVIGO | lemborexant | Eisai Inc. | NDA | Current |
| 62856-455 | DAYVIGO | lemborexant | Eisai Inc. | NDA | Current |
| 62856-455 | DAYVIGO | lemborexant | Eisai Inc. | NDA | Current |
| 62856-455 | DAYVIGO | lemborexant | Eisai Inc. | NDA | Current |