# LABETALOL HYDROCHLORIDE
> **NDA213330** · New Drug Application · Sponsor: HIKMA · Approved 2020-11-09
## Drug
- **FDA Application Number:** NDA213330
- **Application type:** New Drug Application
- **Brand name:** LABETALOL HYDROCHLORIDE
- **Generic name:** LABETALOL HYDROCHLORIDE
- **Active ingredients:** LABETALOL HYDROCHLORIDE
- **Dosage form:** SOLUTION
- **Route:** INTRAVENOUS
- **Marketing status:** Discontinued
- **Sponsor:** HIKMA
- **Manufacturer:** Hikma Pharmaceuticals USA Inc.
- **First approval:** 2020-11-09
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213330)
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*MORVS · CC0 1.0*