FDA — authorised 1 August 1984
- Application: NDA018716
- Marketing authorisation holder: ALVOGEN
- Local brand name: TRANDATE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Labetalol Injection in United States
FDA authorised Labetalol Injection on 1 August 1984
Marketing authorisations
FDA — authorised 1 August 1984
- Application: NDA018686
- Marketing authorisation holder: SCHERING
- Local brand name: NORMODYNE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 1 August 1984
- Application: NDA018687
- Marketing authorisation holder: SCHERING
- Local brand name: NORMODYNE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 December 1985
- Application: NDA019425
- Marketing authorisation holder: SEBELA IRELAND LTD
- Local brand name: TRANDATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Status: approved
Labetalol Injection in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Labetalol Injection approved in United States?
Yes. FDA authorised it on 1 August 1984; FDA authorised it on 1 August 1984; FDA authorised it on 1 August 1984.
Who is the marketing authorisation holder for Labetalol Injection in United States?
ALVOGEN holds the US marketing authorisation.