| Application # | Type | Sponsor | Notes | Product # | Drug Name | Form | Strength | Active Ingredient | Approval Date | Marketing Status | Reference Standard |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 215390 | NDA | BIOXCEL | 001 | IGALMI | FILM;BUCCAL, SUBLINGUAL | EQ 0.12MG BASE | DEXMEDETOMIDINE HYDROCHLORIDE | 2022-04-05 | Prescription | Yes | |
| 002 | IGALMI | FILM;BUCCAL, SUBLINGUAL | EQ 0.18MG BASE | DEXMEDETOMIDINE HYDROCHLORIDE | 2022-04-05 | Prescription | Yes |