# TRANDATE
> **NDA019425** · New Drug Application · Sponsor: SEBELA IRELAND LTD · Approved 1985-12-31
## Drug
- **FDA Application Number:** NDA019425
- **Application type:** New Drug Application
- **Brand name:** TRANDATE
- **Generic name:** Labetalol Hydrochloride
- **Active ingredients:** LABETALOL HYDROCHLORIDE
- **Dosage form:** INJECTABLE
- **Route:** INJECTION
- **Marketing status:** Discontinued
- **Sponsor:** SEBELA IRELAND LTD
- **First approval:** 1985-12-31
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=019425)
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