← FDA Drug Approvals (Drugs@FDA)
TRANDATE
NDA · New Drug Application · Sponsor: ALVOGEN · Approved 1984-08-01
Drug application
- FDA Application #
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
- Authoritative
- Drugs@FDA application overview
- Machine
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