# TRANDATE
> **NDA018716** · New Drug Application · Sponsor: ALVOGEN · Approved 1984-08-01
## Drug
- **FDA Application Number:** NDA018716
- **Application type:** New Drug Application
- **Brand name:** TRANDATE
- **Generic name:** Labetalol Hydrochloride
- **Active ingredients:** LABETALOL HYDROCHLORIDE
- **Dosage form:** TABLET
- **Route:** ORAL
- **Marketing status:** Discontinued
- **Sponsor:** ALVOGEN
- **First approval:** 1984-08-01
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=018716)
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