# DEXMEDETOMIDINE HYDROCHLORIDE
> **ANDA208103** · Abbreviated New Drug Application (Generic) · Sponsor: BAXTER HLTHCARE CORP · Approved 2026-04-15
## Drug
- **FDA Application Number:** ANDA208103
- **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:** BAXTER HLTHCARE CORP
- **Manufacturer:** Baxter Healthcare Corporation
- **First approval:** 2026-04-15
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208103)
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