# DEXMEDETOMIDINE HYDROCHLORIDE
> **ANDA216254** · Abbreviated New Drug Application (Generic) · Sponsor: NEPHRON · Approved 2026-09-28
## Drug
- **FDA Application Number:** ANDA216254
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** DEXMEDETOMIDINE HYDROCHLORIDE
- **Generic name:** Dexmedetomidine Hydrochloride
- **Active ingredients:** DEXMEDETOMIDINE HYDROCHLORIDE
- **Dosage form:** INJECTABLE
- **Route:** INJECTION
- **Marketing status:** Prescription
- **Sponsor:** NEPHRON
- **First approval:** 2026-09-28
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216254)
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