FdaApplication
NDA 215390
Identifiers
- fda_app_no: NDA215390
Properties
| Property | Value |
|---|---|
| applicant_name | BIOXCEL THERAPEUTICS INC |
| application_type | NDA |
| approval_date | 2022-04-05 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| IGALMI | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 0.12MG BASE | FILM;BUCCAL, SUBLINGUAL |
| IGALMI | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 0.18MG BASE | FILM;BUCCAL, SUBLINGUAL |
2 products