FDA — authorised 25 June 1991
- Application: NDA019851
- Marketing authorisation holder: VALIDUS PHARMS
- Local brand name: LOTENSIN
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 ACEI in United States
FDA authorised ACEI on 25 June 1991
Marketing authorisations
FDA
- Status: approved
ACEI in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Cardiovascular approved in United States
Frequently asked questions
Is ACEI approved in United States?
Yes. FDA authorised it on 25 June 1991; FDA has authorised it.
Who is the marketing authorisation holder for ACEI in United States?
VALIDUS PHARMS holds the US marketing authorisation.