Application 215390
- Type
- NDA
- Sponsor
- BIOXCEL THERAPEUTICS, INC.
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | IGALMI | DEXMEDETOMIDINE | FILM;SUBLINGUAL | | No | No |
| 002 | IGALMI | DEXMEDETOMIDINE | FILM;SUBLINGUAL | 180MCG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 81092-1120 | IGALMI | DEXMEDETOMIDINE | BioXcel Therapeutics, Inc. | NDA | Current |
| 81092-1120 | IGALMI | DEXMEDETOMIDINE | BioXcel Therapeutics, Inc. | NDA | Current |
| 81092-1180 | IGALMI | DEXMEDETOMIDINE | BioXcel Therapeutics, Inc. | NDA | Current |
| 81092-1180 | IGALMI | DEXMEDETOMIDINE | BioXcel Therapeutics, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 84243 | SUPPL | 2025-11-21 |
| 84239 | SUPPL | 2025-11-20 |
| 73264 | ORIG | 2023-01-23 |
| 73263 | ORIG | 2023-01-23 |
| 72464 | SUPPL | 2022-10-25 |
| 70739 | ORIG | 2022-04-11 |
| 70711 | ORIG | 2022-04-06 |