# DEXMEDETOMIDINE HYDROCHLORIDE
> **ANDA202126** · Abbreviated New Drug Application (Generic) · Sponsor: GLAND · Approved 2015-08-20
## Drug
- **FDA Application Number:** ANDA202126
- **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:** GLAND
- **Manufacturer:** Sun Pharmaceuticals Industries, Inc.
- **First approval:** 2015-08-20
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=202126)
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