Application 214517
- Type
- NDA
- Sponsor
- VANDA PHARMACEUTICALS INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | HETLIOZ | TASIMELTEON | CAPSULE;ORAL | 20MG | Yes | No |
| 002 | HETLIOZ LQ | TASIMELTEON | SUSPENSION;ORAL | 4MG/ML | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 43068-304 | Hetlioz | tasimelteon | Vanda Pharmaceuticals Inc. | NDA | Current |
| 43068-304 | Hetlioz | tasimelteon | Vanda Pharmaceuticals Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 68121 | ORIG | 2021-07-19 |
| 65484 | ORIG | 2020-12-02 |
| 65481 | ORIG | 2020-12-02 |