approval · primary record
DEXMEDETOMIDINE HYDROCHLORIDE
2 approval events · latest 2026-05-01
| Agency | FDA |
|---|---|
| Submission type | NDA |
| Latest action | 2026-05-01 |
| Approval events | 2 |
| Brand | DEXMEDETOMIDINE HYDROCHLORIDE |
| Sponsor | HQ SPCLT PHARMA |
| Route | INTRAVENOUS |
Approval history
2 actions on record. The drug is the stable record; each action below is an event with its own date, so this URL keeps working as new actions arrive.
| Date | Agency | Type | Brand | Sponsor | Route |
|---|---|---|---|---|---|
| 2026-05-01 | FDA | NDA | DEXMEDETOMIDINE HYDROCHLORIDE | HQ SPCLT PHARMA | INTRAVENOUS |
| 2025-11-19 | FDA | NDA | IGALMI | BIOXCEL | BUCCAL, SUBLINGUAL |
Provenance
- Source: openFDA Drugs@FDA
- Fetched at: 2026-10-30T00:31:26.261Z
- Licence class: public-domain
- Verdict: primary-source
- Entity id: approval:dexmedetomidine-hydrochloride
This record is rendered from the AEaH spine. If the source is unreachable the page is not generated.
Same entity, elsewhere in the suite
- Dexmedetomidine Hydrochloride · compound