← FDA Drug Approvals (Drugs@FDA)
TRANDATE
NDA · New Drug Application · Sponsor: SEBELA IRELAND LTD · Approved 1985-12-31
Drug application
- FDA Application #
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
- Authoritative
- Drugs@FDA application overview
- Machine
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