# LABETALOL HYDROCHLORIDE
> **ANDA075303** · Abbreviated New Drug Application (Generic) · Sponsor: HIKMA · Approved 1999-05-28
## Drug
- **FDA Application Number:** ANDA075303
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** LABETALOL HYDROCHLORIDE
- **Generic name:** LABETALOL HYDROCHLORIDE
- **Active ingredients:** LABETALOL HYDROCHLORIDE
- **Dosage form:** INJECTABLE
- **Route:** INJECTION
- **Marketing status:** Prescription
- **Sponsor:** HIKMA
- **Manufacturer:** Civica, Inc.
- **First approval:** 1999-05-28
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=075303)
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